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vatolinalex

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BACKGROUND OF THE INVENTION The present invention relates to improvements in display cabinets of the type employing a plurality of rotating shelves to carry goods to and from a viewing window in one side of the cabinet. More particularly, the invention seeks to simplify and reduce the cost of manufacturing of a drive mechanism which maintains the rotating shelves level at all times and stabilizes them, so that they will not tend to swing on their suspension pivots during rotation. By means of the invention, the above objectives are fully realized without the need for close machining tolerances or expensive mechanical components. The mechanism is also compact and practically maintenance-free. Other features and advantages of the invention will become apparent to those skilled in the art during the course of the following description. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a display cabinet equipped with rotating shelf mechanism in accordance with the invention. FIG. 2 is a fragmentary exploded perspective view of the mechanism. FIG. 3 is a fragmentary horizontal section taken on line 3--3 of FIG. 1. FIG. 4 is a transverse vertical section taken on line 4--4 of FIG. 3. FIG. 5 is a horizontal section taken on line 5--5 of FIG. 3. FIG. 6 is a transverse vertical section taken on line 6--6 of FIG. 3. FIG. 7 is a view similar to FIG. 5 showing a modification of the invention. DETAILED DESCRIPTION Referring to the drawings in detail wherein like numerals designate like parts, a display cabinet 20 for merchandise houses a series of rotating shelves 21 which support the merchandise being displayed. A drive motor 22 mounted on one end wall 23 of the cabinet 20 is operatively coupled with and drives a main drive shaft 24 extending lengthwise of and arranged centrally in the display cabinet. The far end of the drive shaft 24 is journaled in a suitable bearing 25 on the adjacent cabinet end wall 26. A disc 27 having circumferentially equidistantly spaced radial slots 28 in its peripheral edge is fixed on the drive shaft 24 near the motor 22 and revolves with the drive shaft. A corresponding number of crank links 29 have their corresponding end extensions 30 received in bushings 31 formed of dry lube material, and these bushings engage in the radial slots 28 of disc 27. The merchandise shelves 21 which correspond in number to crank links 29 and slots 28 have rising end walls 32 to which the link extensions 30 are rigidly connected as by welding. The far end terminals 33 of crank links 29 are parallel to the extensions 30 and are received in dry lube bushings 34 which in turn engage freely or loosely in openings 35 of a ring 36 disposed axially outwardly of the disc 27 in parallel relation thereto. As rotation is imparted by drive shaft 24 to the disc 27 which is concentric with the drive shaft, the ring 36 which is eccentrically disposed is caused to follow the disc through the driving action of the links 29 on the ring 36. During such driving action, the ring 36 is constrained against horizontal displacement by a pair of diametrically opposed vertical members 37 fixed to the adjacent side wall 23 by screws 38. These vertical members have opposing longitudinal vertical grooves 39 formed therein which receive the peripheral edge portion of the ring 36. The ring 36 is floatingly arranged in the grooves 39 of members 37. Guide members 37 carry interior flanges 40 rigid therewith at right angles thereto, which flanges are located between the disc 27 and ring 36, FIG. 3. During rotation of the disc 27, as each radial slot 28 reaches the three o'clock or nine o'clock position, FIG. 4, an arcuate edge 41 on the flange 40 comes into engagement with the terminal 30 of each crank link 29 preventing each crank link from being displaced radially outwardly in the slot 28, which otherwise might occur if the retaining flange 40 were not present. At other points during rotation of the disc 27 ahead of and after the three o'clock and nine o'clock positions, there is no need for the edge 41 since the crank links themselves will hold the extensions 30 and their bushings 31 in the radial slots 28. During the rotation of shaft 24 and disc 27, referring to FIG. 4, the links 29 remain parallel and remain vertical regardless of the angular position of the disc 27 and the ring 36. The disc and ring will turn in unison and the ring will remain eccentrically disposed to the common axis of drive shaft 24 and disc 27. The several shelves 21 will remain level at all times during the rotational cycle and cannot swing on the axes of extensions 30. The levelness of the rotating shelves 21 can be accurately adjusted in the assembling of the mechanism by adjusting the two members 37 laterally relative to the axis of drive shaft 24. As viewed in FIG. 4, when the two parallel members 37 are adjusted to the left, all of the shelves 21 will be rotated clockwise around the axes of extensions 30. Similarly, when members 37 are adjusted to the right in FIG. 4, the shelves will turn counterclockwise. By virtue of this adjustment, the display shelves can be accurately leveled in a simple and economical manner. The end walls 32 of shelves 21 adjacent to the shaft bearing 25 are suspended from a disc 42 mounted on the drive shaft 24 through a series of pins 43 having dry lube bushings 44. The pins 43 are in axial alignment with link extensions 30 at the far ends of the shelves adjacent to the drive mechanism. In the modification shown in FIG. 7, the comparatively costly main drive shaft 24 can be eliminated without loss of its function. To enable this, the described drive mechanism including disc 27, ring 36, links 29 and associated parts including members 37 is duplicated at the ends of the shelves 21 away from the motor 22 and the driving force for rotation is transmitted through the shelves themselves. A short stub shaft 45 held in bearing 25 supports the disc 27 away from the motor 22 and the motor drives a similar short shaft 46 to which the near disc 27 is attached. The display cabinet in either form can be used with various goods, such as jewelry or perishable products. In the latter case, it may be desirable to heat, cool and/or ventilate the display cabinet. A heat exchange unit, not shown, including a blower, for refrigeration or heating, can be housed in a provided end space 47, FIG. 1, of cabinet 20 to deliver hot or cold air to the interior of the cabinet at 48, see FIGS. 3 and 7. The cabinet includes at least front sliding doors 49 which are transparent and may include similar rear doors for the loading of merchandise after same are removed by customers through the front doors 49. The rear doors are omitted in the drawings. A switch, not shown, triggered by operation of the doors 49 will shut off the blower whenever the doors are opened, in cases where the heat exchange unit is used. While the invention has been disclosed in this application as a mechanism for maintaining the rotating shelves of a display cabinet level and stable during their orbital movement, it should be understood that the mechanism forming the subject matter of the invention is fully capable of additional and more general usage and may, for example, form the drive mechanism for various devices which require continuous orbital movement with the leveling and stablizing advantages afforded by the invention. It is to be understood that the forms of the invention herewith shown and described are to be taken as preferred examples of the same, and that various changes in the shape, size and arrangement of parts may be resorted to, without departing from the spirit of the invention or scope of the subjoined claims.

1a

FIELD OF THE INVENTION This invention relates to a light duty and weight, combination floor vacuum cleaner, duster and upholstery and stair tread cleaner. BACKGROUND OF THE INVENTION A variety of different dry type vacuum cleaners are available for a variety of uses ranging from heavy duty rug and carpet cleaners, light duty rug and carpet cleaners for picking small spills and crumbs, compact hand held cleaners for cleaning cushions, pillows, stair treads and the like. There have also been developed such cleaners particularly designed or equipped with conversion tools to be used for special purposes such as removal of spider webs near the ceiling and adjusting drapery valances and the like. In recent years due to the introduction of plastics and substantial improvements in the design of the electric motors for this type of equipment, the bulk and weight of these machines has been reduced substantially. Also, the development of compact rechargeable, heavy duty batteries has made possible the so-called cordless vacuum cleaner. However, there has remained the problem that the machines were limited to one or two functions. For other functions it has been necessary to have a second tool or a bulky and clumsy conversion kit. An example of a basically single function, floor cleaning vacuum cleaner not suitable for use with cushions or well adapted for cleaning valances or removal of cobwebs close to the ceiling is disclosed in U.S. Pat. No. Des. 280,033, issued Aug. 6, 1985 to Isshin Miyamoto et al. Other examples of a basically single purpose machine are disclosed in U.S. Pat. No. 4,011,624 issued Mar. 15, 1977 to Mark A. Proett and U.S. Pat. No. Des. 274,381 issued June 19, 1984 to Lawrence I. Chiu. In both cases, these machines could be used to remove a floor spill but the use would require the operator to stoop or to kneel on the floor, either of which is inconvenient at best, and for some people, physically impossible. The necessity for having different machines available to satisfy the needs of different circumstances is expensive and for many people creates a problem with storage space. It can also be frustrating when part way through a particular job one finds that a second and different tool is necessary to complete it. BRIEF DESCRIPTION OF THE INVENTION Through a unique "tool within a tool" and "handle within a handle" construction, the invention provides, in a single machine a vacuum cleaner which, without the need of a conversion kit or tray of accessories functions as a full height floor vacuum, a compact hand held upholstery cleaner and a machine having the ability to be used for cleaning out of reach surfaces and objects such as valances. When used as a standard upright, there is no necessity for the user to stoop or kneel. By removing the carpet head, which is simply a pull apart operation, the machine is converted to use for cleaning valances and difficult to reach areas such as ceilings and the like. This simple conversion is made possible by the fact that the insertion port where the carpet head is inserted into the apparatus is itself configured as a cleaning tool. Thus, the carpet head tool is mounted within another too, making conversion of the apparatus from one type of cleaner to another very simple and direct. By unlatching and removing the handle, the machine is converted into a compact, hand held vacuum cleaner for cleaning upholstery, furniture cushions and stair treads. This is made possible by making one end of the machines primary body a handle for the machine when using as a compact hand held unit and also as the anchor for the handle extension used when the machine is adapted to floor or ceiling use. Thus, one handle which creates one type of machine is removably mounted within another handle which, when the first handle is removed, creates a totally different type of machine. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an oblique view of the vacuum cleaner embodying this invention; FIG. 2 is an exploded view of the vacuum cleaner illustrated in FIG. 1, shown on a reduced scale; FIG. 3 is an oblique view of the main body of the vacuum cleaner; FIG. 4 is an end view taken along the plane IV--IV; FIG. 5 is a fragmentary front view of the vacuum cleaner illustrated in FIG. 1; FIG. 6 is an end view taken along the plane VI--VI of FIG. 5; FIG. 7 is an enlarged, fragmentary sectional view taken along the plane VII--VII of FIG. 3; FIG. 8 is a broken bottom view of the vacuum cleaner with the carpet cleaning head removed; FIGS. 9 and 9A are enlarged fragmentary sectional views taken along the plane IX--IX of FIG. 1; FIG. l0 is a side elevation view of the vacuum cleaner as it would appear while being used to vacuum the juncture of a wall and ceiling; and FIG. 11 is a fragmentary sectional view taken along the plane XI--XI of FIG. 7. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1 the numeral 10 refers to a vacuum cleaner having a main body 11, a floor and carpet pickup head 12 and an extension handle 13. As is illustrated in FIG. 2 both the extension handle 13 and the pickup head 12 can be detached from the main body 11. The main body 11 has a two piece housing 14 with a front portion 15 and a rear portion 16 which are detachably latched together by an interfitting latch 17 at the bottom (FIG. 8) and a locking latch 18 at the top (FIG. 1). The locking latch has an operating lever which when depressed by the operator at its rear end releases the front portion providing access to the interior of the front portion. The interior of the front portion 15 serves as a collection chamber for the material such as dirt etc. picked up by the vacuum. The vacuum is created by a motor driven air impeller housed in the front part of the rear portion 16 powered by a rechargeable battery pack also housed in the rear portion. The operation of the motor is controlled by a switch 19. The rear end of the rear portion is shaped to provide a rearwardly extending primary handle 20 of a length and cross-sectional size and shape to be conveniently and comfortably held in the user's hand. The motor control switch 19 is mounted in the forward portion of this handle where the operator can maneuver it by use of the thumb. An opening 30 is provided in the rear end of the primary handle 20 of a size to telescopically receive the end of the wand-like secondary or extension handle 13 (FIG. 6). Within the handle 20, a plurality of spaced, circumferential ribs 32 and longitudinal stiffeners 33 form an elongated circular passageway or tunnel closely fitting about the extension handle 13, so that the extension handle, when fully inserted can firmly support the main body without conveying to the user any sense of looseness (FIGS. 9 and 9A). A latch 34 is pivotally mounted to the handle 20 and is provided with a finger 35 which seats in the latch opening 36 in the extension handle 13 (FIG. 9). The latch 34 is pivoted into locking engagement with the handle by a spring 37 (FIG. 9A). To facilitate entry of the end of the extension handle into the passageway at the top and bottom of the entry path inclined guide surfaces 38 are provided. The length of the extension handle 13 is a matter of choice. A convenient length for normal household usage would be that which would make it easy to use the vacuum cleaner, with carpet head removed, to remove cobwebs at the ceiling/wall juncture in a room of standard ceiling height of eight feet as illustrated in FIG. 10 without requiring the operator to grip the handle at a point above the operator's head. It will be recognized that for use in older houses and some commercial facilities having higher ceilings such as 10 or 12 feet either a longer or a sectional handle could be provided and such would be within the scope of this invention. The end of the handle is provided with a suitable grip 39. The front or bottom face 50 of the main body is inclined rearwardly and downwardly from the upper or front face of the main body at an angle of about 45° (FIGS. 7 and 10). This inclination is such that the front face is generally parallel to the floor when the machine is being used to pick up dirt without use of the carpet head and with the operator holding the handle at a convenient angle while standing erect. It also permits this face to be generally parallel to a wall surface when the equipment is used to clean the upper portion of a wall surface in the manner illustrated in FIG. 10. It will also be observed from FIG. 10 that by inverting the vacuum cleaner about its longitudinal axis the inclination of the front face makes it convenient to use the machine for removing material clinging to the ceiling. This arrangement also makes the machine particularly effective for picking up floor spills such as cereal, ashes, crumbs or the like. The face 50 has a central opening 51 which provides a restricted opening to the internal dirt collection chamber. Opening 51 is laterally elongated, specifically preferably rectangular, so as to improve the pick up characteristics when using face 50 and opening 51 as a pick up tool. The rectangular opening provides good equivalent orifice relative to the floor. Thus, when used for picking up spilled materials, a strong air current is generated in a small area capable of picking up relatively heavy items. Also, this type of strong air current is effective for removing lint and embedded dirt which tends to cling tenaciously to fabric surfaces such as pillow covers and upholstery. Opening 51 is framed by a generally rounded lip 58 and on three sides by inwardly beveled walls 59 (FIGS. 4, 7 and 11). Rounded lip 58 helps prevent the apparatus from scratching hard surfaces or becoming nagged in drapes or fabric, as often happens when one attempts to use the metal pipe of a canister vacuum as a tool. Preferably, walls 59 are beveled at a relatively shallow angle, preferably less than 45° but more than 15° to the plane of face 50, to enhance the rapid flow of air around edge 58 and into the generally rectangular throat 54 surrounding opening 51, which serves as a passageway for air being drawn into the interior dirt collection chamber of the apparatus. To adapt the equipment to general use on floor surfaces, a pickup head attachment 12 equipped with a rectangular, tubular nozzle or coupling 52 is provided. The tubular nozzle is pivotally mounted to the floor engaging body of the head in a conventional manner. The tubular nozzle is coupled to the main body 11 by being telescopically inserted into the opening 51 where it presses firmly against the ribs 53 projecting from the walls of the throat 54 extending inwardly from the opening 51 (FIGS. 4 and 7). The engagement between the ribs 53 and the sides of the nozzle together with a small taper in the walls of the throat provide a firm but slidably disengageable anchor for the pickup head 12. Insertion of the nozzle is limited by the stops 55. At the inner end of the throat a flapper valve 56 is provided to prevent escape of the material collected in the dirt chamber when the motor is turned off. The flapper valve 56 is secured to the plastic posts 57 which are integral with the molded housing. The pickup head is conventional in providing a means for causing a high velocity stream of air to pass through or close to the surface to be cleaned to entrain dirt and other materials on or in that surface. All of the various parts of the main body 11 except the motor, the battery, the extension handle, wiring and incidental fasteners used for assembly are of molded plastic, thus, minimizing weight. The handle is preferably metal tubing for rigidity. The result is a very light weight machine which can be easily used without fatigue even when it is entirely supported by the operator as indicated in FIG. 10. The invention provides a compact, unitized vacuum cleaner which the user carries as a single, light weight unit to the place where it is to be used. At the point of use, the operator adapts the machine to the particular requirements of the job. If it is removing a spill from the carpet the operator simply turns on the motor and uses the machine as is. If the spill has been embedded in a carpet surface, by removing the head 12, the displacement force of the vacuum can be concentrated by exposing the carpet surface to the opening 51 only. If it is to be used to remove a spider web or dust from a valance or the top of a picture or the top rail of panelling, the operator simply removes the carpet head 12 and proceeds with the job. If the job objective is vacuuming upholstery, such as to remove something spilled on it, in addition to removal of the carpet head 12, the extension handle 31 is removed and the main body of the machine is used as a compact hand vacuum while gripping it by the primary handle 20. In each case no accessories or extra equipment has to be brought with the machine. Being of the cordless type, the accessibility of electrical power is irrelevant. The absence of extension cords significantly reduces the weight and pull exerted by the machine which must be supported by the operator. When the clean up is complete, if the machine has been taken apart, it can be reassembled for storage simply by reattaching the carpet head and the extension handle. When returned to storage, it is again recharged by inserting the charging unit in the charger connection 21 (FIG. 8). Further, because the machine is a simple integrated, compact unit which is neither bulky nor of a complex shape, it occupies a minimum of storage space, an important feature in many homes, condominiums and apartments. Having described a preferred embodiment of the invention, it will be understood that various modifications of it can be made without departing from the principles of the invention. Such modifications are to be considered as included in the hereinafter appended claims unless these claims, by their language, expressly state otherwise.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 61/118,602, filed on Nov. 29, 2008. The disclosure of the above application is incorporated herein by reference. TECHNICAL FIELD [0002] The present disclosure pertains to medical devices, and more particularly to conductive couplings for medical electrical leads. BACKGROUND [0003] A medical electrical lead typically includes one or more elongate conductors, each of which electrically couples an electrode of the lead to a corresponding connector contact of the lead. A conductive coupling between a lead conductor and electrode should add a minimum of electrical resistance to the electrical circuit, which is formed by the electrode, conductor, and contact, and should have an adequate strength to maintain good contact under operational loading conditions. [0004] Because medical electrical leads are typically constructed to have the lowest possible profile, without compromising functional integrity, reliability and durability, relatively low profile conductive couplings, which do not significantly increase a profile of the lead are also desired. Although some low profile conductive couplings have been previously disclosed, there is still a need for improved couplings which, in addition meeting the above criteria, provide flexibility in the manufacture of various configurations of medical electrical leads. [0005] As lead bodies become smaller and the height of the connections between conductors and electrodes is reduced, it becomes increasing difficult to make low profile junctions that allow conductor coils to be welded to without damaging or significantly affecting the cable. For example, a radially symetrical crimp barrel or crimp sleeve located entirely within a lead lumen as described in U.S. patent application Ser. No. 11/549,284 filed Oct. 13, 2006 may only have a 3 mil wall due to height constraints. The thermal mass, wall thickness and available material to make an effective weld is negligible. Prior designs such as those disclosed in U.S. Pat. No. 5,676,694 issued to Boser et al and incorporated herein by reference in its entirety have provided an extension to the crimp sleeve which extends outward from the lead lumen to the exterior of the lead body, allowing the a weld to an associated electrode coil to be made spaced from the lead conductor. However, further reductions in lead profile are still desirable over leads fabricated using this connector mechanism. SUMMARY OF THE INVENTION [0006] The present invention is configured to provide an offset weld and crimp in a coupling component that can be located entirely within a lumen of a lead body. This end is accomplished by providing an asymmetric coupling component is provided with a crimp recess, for example a groove or a bore extending along one side of the component and a thickened portion offset laterally from the groove or bore and having a welding surface displaced laterally from the groove or bore. While the embodiments illustrated herein are those employing a crimping groove, for purposes of understanding the invention it should be understood that a bore may be substituted. In preferred embodiments, the crimp recess is used to receive a stranded or cabled conductor within the lead body and the offset portion is used to attach to one or more filars of an electrode coil by welding thereto. [0007] The component displays a generally flattened configuration, with a thickness substantially less than its width as measured perpendicular to the crimp groove or bore. This configuration in turn allows the wall thickness and mass in the area of the weld to be significantly increased and moves the weld energy away form the cable while still maintaining a low profile. In order that the component does not add to the diameter of the lead body, it is preferably located in the lead so that the thickened offset portion extends from the groove or bore along either the longitudinal axis or around the circumference of the lead body. The component may also be provided with curved inner or outer surfaces extending across its width to assist in conforming to the typically cylindrical geometry of leads' internal lumens and surfaces. [0008] The flat geometry and/or curved geometry of the coupling component allows for easy orientation of the component during the welding/assembly. The invention may also comprise an optional recessed region in the offset region of the sleeve. In addition, the electrode wires can be welded together to improve the ability of placing two or more electrode wires in a single recess region. This is particularly effective when attaching flat wire electrode coils to the sleeve. As a further embodiment/option, to aid the cable joining process the inner channel of the sleeve can incorporate an interlock that is engaged when clamping the sleeve on to the cable. This interlock can be useful when the coupling component is fabricated of a material that has spring back (e.g. Titanium). [0009] In some embodiments, the conductor to which the coupling component is crimped is a cabled conductor extending parallel to the axis of the lead body and the groove or bore extends parallel to the axis of the lead body. In other embodiments, the conductor to which the coupling component is crimped is a coiled conductor having individual coils extending generally transverse to the axis of the lead body the groove or bore correspondingly extends generally transverse to the axis of the lead body. In embodiments in which employ a groove, as disclosed in more detail herein, the groove is defined is defined by first and second arms which define the groove therebetween. [0010] The electrode preferentially takes the form of an electrode coil mounted around the outer circumference of the lead body and preferably includes a portion or component that component that extends through the outer insulation sidewall of the lead and into the interior lumen or space within the lead that encloses the lead conductor and the coupling component. The weld is thus located entirely within the outer diameter and preferably within the inner diameter of the lead body. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The following drawings are illustrative of particular embodiments of the present disclosure and therefore do not limit the scope 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. Embodiments will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements. [0012] FIG. 1 is a plan view of an exemplary medical electrical lead that may include embodiments of the present invention. [0013] FIG. 2A is a perspective view of a coupling component, according to some embodiments. [0014] FIGS. 2B-C are each a perspective view of a portion of the lead shown in FIG. 1 , wherein an outer insulation sidewall is cut away to show alternative conductive couplings, according to some alternate embodiments. [0015] FIG. 2D is a cross-section view of an exemplary conductor. [0016] FIG. 3 is a perspective view of a portion of the lead shown in FIG. 1 , wherein an outer insulation sidewall is cut away to show a conductive coupling, according to yet further embodiments. [0017] FIGS. 4A-B are perspective views of coupling components, according to some alternate embodiments. [0018] FIG. 5 is a cross-section through the lead of FIG. 1 showing a conductive coupling within an alternative insulative sidewall configuration, according to some alternate embodiments. DETAILED DESCRIPTION [0019] 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 practical illustrations for implementing exemplary embodiments. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of skill in the field of the disclosure. Those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be utilized. [0020] FIG. 1 is a plan view of an exemplary medical electrical lead 100 that may include embodiments of the present invention. FIG. 1 illustrates lead 100 including an outer insulation sidewall 110 that extends between a proximal portion 116 and a distal portion 117 ; proximal portion 116 includes electrical contact surfaces 12 , 14 and 15 , which are shown mounted on connector legs of proximal portion 116 ; and distal portion 117 includes electrode surfaces 120 , 140 and 151 . Dashed lines in FIG. 1 schematically illustrate conductors 220 , 240 and 250 which extend within outer insulation sidewall 110 to couple each of electrode surfaces 120 , 140 , 151 to a corresponding contact surface 12 , 14 , 15 . Thus, lead 100 is a tripolar lead that may provide pacing and sensing, via electrode surfaces 120 and 140 , and defibrillation, via electrode surface 151 . According to some preferred embodiments, conductor 220 is formed as a coil to provide torque transfer between proximal portion 116 and distal portion and to electrically couple electrode surface 120 to contact surface 12 , and conductors 240 , 250 are each formed as a cable to electrically couple electrode surfaces 140 , 150 to contact surfaces 14 , 15 , respectively. According to embodiments described herein, electrode surface 151 is a first portion of an electrode component 150 , and a second portion of electrode component 150 extends within outer insulative sidewall 110 for coupling with conductor 250 . It should be noted that either or both of the components including electrode surfaces 120 and 140 may also include portions which are coupled to the corresponding conductors 220 , 240 in a manner similar to embodiments described herein. [0021] Two exemplary lead configurations, or arrangements of conductors 220 , 240 , 250 will be described herein (a first in conjunction with FIGS. 2B-C and 3 , and a second in conjunction with FIG. 5 ), but any suitable arrangement of conductors 220 , 240 , 250 , within outer insulation sidewall 110 , is within the scope of the present invention. Furthermore, it should be noted, that embodiments are not limited to inclusion in tripolar pacing and defibrillation leads, like lead 100 , and lead 100 is only an exemplary type of lead used for the purpose of illustration. [0022] FIG. 2A is a perspective view of a coupling component 225 , according to some embodiments, which may be incorporated into lead 100 to form the coupling between conductor 250 and the aforementioned second portion of electrode component 150 . FIG. 2A illustrates coupling component 225 , which is formed from a slug of conductive material, including a first side 211 , a second side 212 , which extends opposite first side 211 , a third side, which extends between first and second sides 211 , 212 , and a fourth side 214 , which also extends between first and second sides 211 , 212 , opposite third side 213 . FIG. 2A further illustrates component 225 including a continuous bulk 25 of the slug of conductive material, which defines third side 213 , and first and second arms 21 , 22 , each of which extend over a length L, from continuous bulk 25 to fourth side 214 ; each arm 21 , 22 is shown having a width W, which is defined between first and second sides 211 , 212 . According to the illustrated embodiment, a space g between first and second arms 21 , 22 of component 225 is intended to receive a length of an elongate conductor, for crimping between the arms, for example, conductor 250 , as shown in FIGS. 2B-C . Although FIG. 2A shows length L being approximately the same for both arms 21 , 22 , it should be noted that, according to alternate embodiments, arms 21 , 22 extend over different lengths; the differing lengths may facilitate an overlapping of arms 21 , 22 when conductor is crimped therebetween, according to these alternate embodiments. [0023] FIGS. 2B-C are each a perspective view of a portion of lead 100 , generally coinciding with section line A-A of FIG. 1 , wherein outer insulation sidewall 110 is cut away to show alternative couplings between electrode component 150 and conductor 250 , via coupling component 225 . FIGS. 2B-C illustrate conductor 250 extending between an inner insulation sidewall 210 and outer insulation sidewall 110 , and coupling component 225 also located between sidewalls 210 , 110 to receive a length of conductor 250 , between arms 21 , 22 , for a crimp joint, and to receive a second portion 152 of electrode component 150 over a surface 20 thereof for a weld joint. Although not shown, it should be appreciated that conductor 220 , which couples electrode surface 120 to contact surface 12 ( FIG. 1 ), extends within inner insulation sidewall 210 . Conductor 240 is also not shown, for the purpose of clarity in the illustration of the coupling; but, it should be appreciated that conductor 240 also extends between inner insulation sidewall 210 and outer insulation sidewall 110 to couple electrode surface 140 to contact surface 14 . Dashed lines in FIGS. 2B-C illustrate an optional extension of conductor 250 beneath first portion 151 of electrode component 150 , beyond the crimped junction with component 225 , for example, to another junction with electrode component 150 , at an opposite end thereof, according to some embodiments. [0024] According to the embodiments of FIGS. 2B-C , a length of conductor 250 , about which arms 21 , 22 are crimped, extends along width W of arms 21 , 22 and, generally, in a direction of a longitudinal axis 11 of lead 100 . Conductor 250 may include a 1×19 cable configured from a plurality of wire strands, for example, formed from MP35N alloy, which is known to those skilled in the art; a cross-section view of conductor 250 including such a cable is shown in FIG. 2D . Silver cored MP35N may also be employed. This present invention is even more important in this context as silver has lower melting point. The conductor wires may alternatively can be cable or solid conductors such as Ta or Ag cored MP35N. FIG. 2D illustrates cable 290 surrounded by an insulative jacket 295 , for example, formed from a fluoropolymer, such as PTFE or ETFE; a portion of jacket 295 is removed from about cable 290 , along the length of conductor 250 which is crimped between arms 21 , 22 , either prior to, or during the formation of the crimp. FIG. 2D further illustrates cable 290 made up of a plurality of wire strands 209 , for example, each having a diameter between approximately 0.0005 inch and approximately 0.005 inch; strands 210 may be stranded with a pitch between approximately 0.3 inch and 0.6 inch. Another exemplary cable, that may form conductor 250 , is known as a 7×7 cable, which includes seven cabled bundles of seven wire strands, and is described in commonly-assigned U.S. Pat. No. 5,760,341, which is hereby incorporated by reference. [0025] According to some embodiments, width W of arms is at least approximately 0.02 inch, and, if a diameter of conductor 250 is approximately 0.006 inch (with insulative jacket 295 removed for the coupling), the space g between arms 21 , 22 is approximately 0.008 inch and a length L over which arms 21 , 22 extend is at least approximately 0.01 inch. A length of arms 21 , 22 may be such that ends of arms do not overlap when the arms are crimped about the conductor, for example, by confronting crimp heads that indent arms 21 , 22 on either side of conductor 250 ; but, according to alternate embodiments, for example, as will be describe below in conjunction with FIG. 3 , a length of arms 21 , 22 is such that one of arms overlaps the other when crimped. [0026] With further reference to FIGS. 2A-C , a surface 20 of component 225 , which faces outer insulation sidewall 110 , is intended to receive an overlapping of second portion 152 of electrode component 150 , for welding thereto, for example, via a solid state YAG type laser, known to those skilled in the art. FIG. 2A illustrates surface 20 of component 225 including a first part 201 , which extends over continuous bulk 25 , and a second part 202 , which extends over first arm 21 ; a spot weld joint between second portion 152 of electrode component 150 and component 225 is preferably located along first part 201 of surface 20 so that a maximum thickness of conductive material, which is present in continuous bulk 25 , as opposed to in arm 21 , is available to maximize the weld pool for the joint. Locating the weld on first part 201 of surface 20 also helps to offset the weld joint from the crimp joint formed between arms 21 , 22 and conductor 250 , so that the formation of the two joints are less likely to compromise one another, while still allowing the entire coupling, between electrode component 150 and conductor 250 , to reside beneath outer insulation sidewall 110 . According to embodiments illustrated by FIG. 2B , second portion 152 of electrode component 150 extends, over first part 201 of surface 20 of component 225 , in a direction transverse to the direction of longitudinal axis 11 ; while, according to embodiments illustrated by FIG. 2C , second portion 152 extends, over first part 201 of surface 20 , in the general direction of longitudinal axis 11 , similar to the extent of the crimped portion of conductor 250 . [0027] Suitable materials from which all, or at least second portion 152 of electrode component 150 may be formed include, without limitation, platinum-iridium alloy, tantalum, tantalum alloys, platinum-iridium clad tantalum and platinum-iridium clad tantalum alloys. Corresponding suitable materials from which component 225 may be formed, in order to accommodate laser welding between bulk 25 and second portion 152 of component 225 , include, without limitation, platinum-iridium alloy, tantalum, tantalum alloys, titanium and titanium alloys. According to some preferred embodiments, if space g and length L of arms 21 , 22 are dimensioned as described above, for conductor 250 as described above, and electrode component 150 is formed by a multi-filar coil, as illustrated, and each filar of the coil has a diameter between approximately 0.005 inch and approximately 0.01 inch, a thickness of bulk 25 (between surface 20 and an opposite surface 20 ′) is between approximately 0.014 inch and approximately 0.02 inch, and an approximate area of first part 201 of surface 20 is the product of width W, which ranges from approximately 0.02 inch to approximately 0.06 inch, and a depth D, which ranges from approximately 0.01 inch to approximately 0.02 inch ( FIG. 2A ). Dimensions may correspondingly be reduced if smaller conductor cables are used. According to some alternate embodiments, electrode component 150 is a coil formed from a single filar, or wire, for example, having a diameter of between approximately 0.005 inch and approximately 0.01 inch. The single or multiple filars forming electrode component 150 , according to some preferred embodiments, are formed from flattened, or ribbon, wire, rather than round wire; a cross-section of the flattened, or ribbon, wire may be defined by a width that is between approximately 0.005 inch and approximately 0.013 inch and a thickness, or height, that is between approximately 0.002 inch and approximately 0.005 inch. [0028] FIG. 3 is a perspective view of a portion of lead 100 ( FIG. 1 ), generally coinciding with section line A-A of FIG. 1 , wherein outer insulation sidewall 110 is cut away to show a conductive coupling, according to yet further embodiments. FIG. 3 illustrates an alternative orientation of both component 225 and the length of conductor 250 , which is crimped between arms 21 , 22 of component 225 . According to the illustrated embodiment, conductor 250 is wound about inner insulation sidewall 210 , and component 225 is oriented such that length L of arms 21 , 22 extends generally in the direction of longitudinal axis 11 and the length of conductor 250 , which is crimped between arms 21 , 22 , extends in the general direction of the winding of conductor 250 , which is transverse to longitudinal axis 11 . Although conductor 240 ( FIG. 1 ) is not shown in FIG. 3 , for the purpose of clarity in the illustration of the coupling, it should be appreciated that conductor 240 may also be wound about inner insulation sidewall 210 , alongside conductor 250 , and extends beneath electrode surface 151 , being routed to a coupling with electrode surface 140 ( FIG. 1 ). FIG. 3 further illustrates arm 21 overlapping arm 22 in the crimp about conductor 250 , for example, having been formed by bending, either as an alternative to, or in addition to indenting, as described above. [0029] FIG. 4A is a perspective view of a coupling component 325 , according to some alternate embodiments, which may be employed, as a substitute for component 225 , in the embodiments illustrated by FIGS. 2B-C and 3 . It should be noted that suitable materials and dimensions for coupling component 325 may be the same as previously described for component 225 . FIG. 4A illustrates coupling component 325 including the four sides 211 , 212 , 213 , 214 , the two arms 21 , 22 , and the continuous bulk 25 , as previously described, such that component 325 has the same general form as component 225 . FIG. 4A further illustrates a surface 30 of component 325 including a first portion 301 , which extends over continuous bulk 25 , a second portion 302 , which extends over arm 21 , and a groove 315 , which is formed in first part 301 of surface 30 and extends orthogonally with respect to length L over which arms 21 , 22 extend. According to the illustrated embodiment, groove 315 is located to receive one or both filars of second portion 152 of electrode component 150 , so as to provide a positively identified position for second portion 152 , for repeatability of welding, from one coupling to the next; and, according to some embodiments, groove 315 may be sized to be a friction fit about second portion 152 , to further hold portion 152 in place for welding. [0030] Dashed lines in FIG. 4A illustrate multiple alternate and/or additional locations and orientations for grooves, according to alternate embodiments of component 325 . According to some alternate embodiments, component 325 includes an additional groove, which extends alongside groove 315 , so that each filar of second portion 152 of electrode component 150 can extend in an independent corresponding groove. According to some further alternate embodiments, component 325 includes one or more grooves that extend at an angle less than 90 degrees with respect to length L over which arms 21 , 22 extend. In order to make embodiments of component 325 less sensitive to orientation, and thereby increase manufacturing flexibility, a duplicate groove or set of grooves may be formed in a first part 301 ″ of a surface 30 ″ of component 325 , which surface 30 ″ is opposite surface 30 . [0031] FIG. 4B is a perspective view of a coupling component 425 , according to yet further alternate embodiments, which may also be employed, as a substitute for component 225 , in the embodiments illustrated by FIGS. 2B-C and 3 . It should be noted that suitable materials and dimensions for coupling component 425 may be the same as previously described for component 225 . FIG. 4B illustrates coupling component 425 including the four sides 211 , 212 , 213 , 214 and the continuous bulk 25 , as previously described for component 225 ; in contrast to component 225 , a first arm 41 of component 425 includes a terminal end 411 that extends toward a second arm 42 of component 425 , and second arm 42 includes a terminal end 412 that extends toward first arm 41 . FIG. 4B further illustrates each of terminal ends 411 , 412 including an interlocking feature, so that arms 41 , 42 mate together when crimped about a conductor, for example, conductor 250 , as illustrated in FIG. 5 . Like coupling components 225 and 325 , component 425 includes continuous bulk 25 defining third side 213 and from which arms 41 and 42 extend; a surface 40 of coupling component includes a first part 401 , which extends over continuous bulk 25 , and a second part 402 , which extends over first arm 41 . According to the illustrated embodiment, and similar to the previously described embodiments, a spot weld joint between second portion 152 of electrode component 150 and component 425 is preferably located along first part 401 of surface 40 so that a maximum thickness of conductive material, which is present in continuous bulk 25 , as opposed to in arm 41 , is available to maximize the weld pool for the joint; such a joint is illustrated in FIG. 5 . [0032] FIG. 5 is a cross-section through medical electrical lead 100 , at section line A-A of FIG. 1 , showing a conductive coupling within an alternative insulative sidewall configuration, according to some alternate embodiments. FIG. 5 illustrates an inner insulative sidewall 510 of lead 100 being integral with outer insulative sidewall 110 in a multi-lumen tube configuration, wherein sidewalls 110 and 510 together form a first lumen 501 , in which conductor 220 extends, a second lumen 502 , in which conductor 240 extends, and a third lumen 503 , in which conductor 250 extends. FIG. 5 further illustrates, a conductive coupling between conductor 250 and electrode component 150 located in third lumen 503 ; the illustrated coupling is formed by interlocking arms 41 , 42 of coupling component 425 crimped about a length of conductor 250 and by a weld joint formed between second portion 152 of electrode component 150 and continuous bulk 25 of coupling component 425 . [0033] In the foregoing detailed description, specific embodiments have been described. 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] This invention relates to surgical devices, and in particular to methods and apparatus for attaching indwelling catheters for draining the urinary bladder that can use pressure actuated magnetic and electret valves sized to be inside catheter tubes and attached to ends of the tubes for restoring normal body cycling functions of allowing the bladder to be filled and emptied, and/or with anti-microbial surfaces, and/or sampling ports and this invention claims the benefit of priority to U.S. Provisional Application 60/280,765 filed Apr. 2, 2001, and U.S. Provisional Application 60/280,766 filed Apr. 2, 2001, and U.S. Provisional Application 60/280,769 filed Apr. 2, 2001, and U.S. Provisional Application 60/284,113 filed Apr. 2, 2001, and this invention is a Continuation-In-Part of U.S. application Ser. No. 10/010,534 filed Dec. 7, 2001, which claims the benefit of priority to U.S. Provisional Application 60/280,767 filed Apr. 2, 2001 and U.S. Provisional Application 280,768 filed Apr. 2, 2001 and U.S. Provisional Application 60/324,601 filed Sep. 25, 2001. BACKGROUND AND PRIOR ART [0002] Catheters are often used for performing continuous bladder irrigation. The most popular type of catheter used is a Foley indwelling or retention catheter that uses an inflatable balloon at the end being inserted into the bladder. See for example, U.S. Pat. No. 4,335,723 to Patel. For the Foley catheter a separate inflation tube adjacent to the main catheter tube or circumferential about the main catheter tube is used to inflate the balloon portion inside the bladder. [0003] Urinary catheters bypass the normal bladder process of storing urine, and for releasing the urine by using the bladder detrusor muscle. Catheters can be a necessary tool to open the bladder to allow urination when patients have trouble urinating. A catheter can be a lifesaving tool since an uncontrolled buildup of urine can cause serious medical problems including renal(kidney) failure and death. [0004] [0004]FIG. 1A shows a prior art indwelling Foley type catheter 1 with a balloon tipped end 3 adjacent to an interior bladder portion 12 adjacent to the urethra(neck) 14 of the bladder 10 . Catheter 1 also includes a longitudinal tube portion 5 having both a main catheter line with output end 9 and a balloon inflation line 6 that feeds to an exterior valve port 7 . FIG. 1B represents a cross-section of a portion inside of the urethra lining 14 having a catheter tube 5 inside the inner walls 15 thereof. A standard catheter tube 5 can have a wall thickness of approximately {fraction (1/16)} of an inch, with an outer diameter of approximately ¼ inch and a hollow inner diameter of approximately ⅛ of an inch. Along the inner wall 6 of the catheter tube 5 can be a fluid fill line 8 that is formed/located about the main drainage tube(lumen) portion 4 of the catheter tube 5 . Although popular, these catheters have many problems. [0005] In the prior art devices that use these typical catheters 5 , the urethra passage 15 in the urethra always remains open to a uncontrolled, involuntary drip/drain urination whether the patient is in need of urinating or not. Thus, the typical catheter tube 5 is not capable of collapsing, and instead forces the urethra passage 15 to be maintained in a substantially open state. [0006] The extra balloon inflation line 8 which could also be placed between 15 and 16 , can also further restrict the diameter of the main catheter line thus reducing bladder drainage rate when needed. Additionally, the extra balloon inflation line 8 can require a larger insertion space diameter in the urethra passage 15 for being inserted into the bladder 10 . Additionally, the Foley catheter must be stiff to be introduced into the bladder, and thus stretches the urethra 14 while being used. [0007] The constant stretching of the passage 15 in the urethra 14 by the non-collapsible catheter tube 5 can be so painful in some patients that its' continued use cannot be tolerated. The continuous stretching of the urethra 14 can also produce urethritis and/or urinary tract infections. Often patients may need medications, sedation and sometimes narcotics to ease extremely painful bladder spasms and urethral discomfort that can develop from using the Folely catheter. [0008] Various types of catheters have been proposed but still fail to overcome the problems of the Foley Catheter. See for example, U.S. Pat. Nos.: 5,183,464 to Dubrul et al.; 5,735,831 to Johnson et al. and 6,096,013 to Hakky et al. Each of these patents generally require inflatable portions or retainers having similar problems. [0009] Catheters have also been known to cause other types of problems. Struvite crystal encrustation is the effect of stagnated urine in the neck of the bladder when using a catheter. In the face of an indwelling catheter, urine can pool at the neck of the bladder, and the pooled urine can shift from a normal acidic pH factor to an abnormal alkaline pH level of 10 or more while it stagnates. Urine shifts to an ammonia state where struvite crystals can precipitate and enlarge on the indwelling catheter. Struvite crystals have sharp, jagged edges which can seriously lacerate the urethral lining when the conventional catheter is removed. This bloody situation is not only excruciatingly painful but can lead to deadly infections. This situation can occur as the bladder loses its natural ability to cyclically flush itself in the face of an indwelling catheter. Bladder wall thickening has also be observed in long-term catheterizations and may be a result of the increasing pH levels. [0010] Urinary tract infections can occur as the urine stagnates and shifts from its normal, acidic antibiotic property through the pH spectrum. Pooled urine that can occur in the neck of the bladder around the Foley balloon and beneath the indwelling catheter can be a natural breeding ground for microbes which can migrate in the body. [0011] Bladder spasms can also occur with an indwelling catheter which causes the bladder to cease its normal cycle of filling and flushing. A dynamic functioning system is converted to a static state with a catheter, and painful bladder spasms can occur. Bladder atone can also occur where short term or more permanent loss of natural bladder functions occurs by using a catheter. [0012] It is also generally well known in medical circles that a human body's primary defense mechanism against urinary tract infections and the other problems listed above is the process known as “wash-out”, where it is advantageous to allow a bladder to normally fill up and be released periodically at one time(all at once) rather than in an uncontrolled drip fashion that would occur with using a traditional catheter. See Cecil, Textbook of Medicine, Saunders Co. 18 th Edition, Page 866, 1988; and Kunin editorial, New England Journal of Medicine, Vol. 319, No. 6. 1988. [0013] Various catheter type instruments and procedures have been used for draining bladders of patients in hospitals. These instruments and procedures have evolved from constant (non-cycling) drip drainage through painfully inserted catheters by siphoning, suction and various types of awkward manually externally controlled cycling apparatus and procedures. Fundamental to an effective, safe, and appropriate device and method is allowing the bladder to fill reasonably and then draining it without a suction pump and without allowing build-up or entry of infectious contaminants in the drainage system. [0014] U.S Pat. Nos. 2,602,448 and 2,860,636 use siphons in combination with reservoirs to provide cyclic draining of the bladder and pressure release is controlled by raising the height of the device on a bedside tree. These devices are subject to distortion by shifting and turning of the patient and are unreliable (can compromise safety) and restrict patients. [0015] U.S. Pat. No. 3,598,124, describes a siphon leg controlled by attaching a catheter to a bedside tree at predetermined heights, to vary the pressure to drain the bladder with a flutter valve to break the siphon action of the system once the bladder has drained. [0016] U.S. Pat. No. 4,230,102, describes a device for the draining of a bladder in which a T-joint has been placed on a catheter and has a pressure membrane attached thereto in a large casing for actuating a pressure switch which in turn actuates an electric motor driving a gear train and cam. A cam follower is spring loaded to clamp the catheter for two minute cycles upon actuation by the pressure switch to drain the bladder. These types of devices, can be expensive, bulky and positions an electricity source close to the catheter and the patient. [0017] U.S. Pat. No. 4,424,058, describes a spring-return valve in conjunction with a siphon-release orifice to prevent both excessive suction and urine from remaining in the system after drainage. A problem with this system was that the restoring force of the spring increased with distance of travel from a closed position. The valve is unsatisfactory because it closed again as soon as the urine fluid pressure dropped off, thus causing fluid to remain trapped in the bladder to stagnate with further elapsed time. Only a full bladder would open it, sometimes at an uncomfortably high (and potentially unsafe) pressure, and then it closed too soon to allow complete drainage unless overridden by the patient bearing down heavily on the lower abdomen. Also, the tube positioning provided a situation for retention of fluid in the system. [0018] U.S. Pat. Nos. 4,865,588 and 5,114,412 to Flinchbaugh, the inventor of the subject invention, describe “magnetic bladder cycler”, title, that requires a “magnet” sliding within a passageway to close a valve port and may use springs and the like, for enhancement. These devices must be added on as, or after, someone is catheterized and is mounted external the catheter. These devices use components substantially larger than a standard diameter of a catheter, thus taking up more space, is more obtrusive, more labor intensive. [0019] None of the proposed patented devices and techniques described above solve all the problems with catheters that are listed above. SUMMARY OF THE INVENTION [0020] A primary objective of the invention is to provide an indwelling catheter that does not stretch out the urethra when being used and can conform to a closed urethra. [0021] A secondary objective of the invention is to provide an indwelling catheter that does not require extra inflation lines for inflating a balloon end nor an inflatable portion. [0022] A third objective of the invention is to provide an indwelling catheter that is less painful and safer when being used than balloon tipped or inflatable catheters. [0023] A fourth objective of the invention is to provide an indwelling catheter that reduces or eliminates the need for medications, sedatives and narcotics as compared to using balloon tipped or inflatable catheter. [0024] A fifth objective of the invention is to provide a catheter having a low pressure magnetic valve for bladder management cyclic flow control. As long as any fluid is coming through the line, the valve will remain open until a complete emptying of the bladder is achieved. [0025] A sixth objective of the invention is to provide catheter having a low pressure magnetic valve for bladder management cyclic flow control that establishes complete and sterile drainage as the bladder is being emptied. [0026] A seventh objective of the invention is to provide a catheter having a low pressure magnetic valve for bladder management cyclic flow control that can be automatically run with a simple and convenient manual override that can be selectively engaged. [0027] An eighth objective of the invention is to provide a catheter having a low pressure magnetic valve for bladder management cyclic flow control that helps restore normal body functions of bladder filling and emptying in a cyclic manner, with normal, healthy pressure sensations in spite of the presence of the catheter which traditionally inhibits “natural” drainage. [0028] The ninth objective of the invention is to provide a catheter having a low pressure magnetic valve for bladder management cyclic flow control which can reduce and eliminate known catheter causing problems such as urinary tract infections, struvite crystal encrustation, bladder spasms and bladder atone. [0029] The tenth objective of the invention is to provide a catheter having magnetic or electret valves that can be used inside of catheter tube for bladder management cycling. [0030] The eleventh objective of the invention is to allow a user wearing a catheter to use their bladder detrusor muscle assist to selectively turn on a valve in the catheter and complete an entire urination emptying cycle of their bladder. [0031] The twelfth objective of the invention is to provide a self sealing sampling port that can be located on the bladder management cycling valve. [0032] The expandable and collapsible catheter includes a catheter tube having a head member with downwardly projecting hollow sleeve with interior and exterior threaded walls inside the catheter, exterior longitudinal slits in the catheter tube, and fixed internal ring having reverse threaded interior walls, within the tube beneath the slits. A user can insert one end of a wire or small-diameter flexible plastic rod type stylette having a threaded tip end through the catheter tube until the threaded tip is screwed in a clockwise direction within the threaded interior walls of the head member. The bottom end of the stylette remains exposed and outside the lower end of the catheter tube. Next the upper head member end of the catheter can be inserted into the bladder through the urethra and positioned in place. The medical practitioner can pull down on the exposed end of the styllete causing the portion of the catheter with the longitudinal strips to expand outward into wing configurations causing, or allowing for, the catheter to be held in an indwelling position within the bladder. Next, the medical practitioner can rotate the stylette in a counter-clockwise direction releasing the threaded end of the stylette from the interior threads of the sleeve in the head member, simultaneously screwing the exterior threaded walls of the sleeve into the interior threaded sleeve of the fixed ring member, thus locking the head member to the ring member while keeping the longitudinal strips in an expanded and folded out positions. The stylette is then removed before the catheter is used for drainage resulting in less pain to the patient, less stretching of the urethra and elimination of problems associated with prior art catheters. [0033] Other embodiments of the invention provide for either consistent magnetic or electret opening and closing of a valve seal with decreased, rather than increased, closing pressure when being opened. As the bladder is being emptied, the decreasing of head pressure against the valve can keep the valve open to establish a complete and sterile drainage. Magnetic and electret valves can be inside the catheter and thin enough to not obstruct fluid flow. [0034] In the invention, valve-closing pressure can decrease as a result of three important factors: (1) magnetic pull of a valve decreases as its open distance from magnetic attraction increases, (2) the gravity-enhanced fluid flow column in the drain down tube provides a slight negative pressure on the back side of the cycling valves (thus tending to hold the valve open until the drain tube empties completely), and (3) fluid passing through the system provides a partial mass flow insulation which tends to hold the cycling valves open, also decreasing any net magnetic or electro static attraction between valve members. [0035] The very low-pressure valve system of the invention allows safe and proper operating pressures, maximum fluid flow rate and complete drainage of the system. [0036] The use method described here is medical in nature, applying to bladder drainage of catheterized patients into a urine collection bag, as needed, in a normal, cyclic fashion. In other words, head pressure of urine building up in volume against the detrusor muscle of a bladder and in a catheter running from the bladder to the valve where it is positioned on a patient's leg or rests on the bed sheet, causes the valve to open away from the valve-port seat. When the valve is opened, distance increases between the valve magnetic member and a member to which it is magnetically attracted in the direction of the valve-port wall, thereby allowing the valve to remain open with less pressure than that initially required to open it. Fluid passing between the open valves which it is attracted magnetically or by electrets decreases further still the closing pressure to offset the head-pressure opening of the valves. [0037] The entire valve system (in the embodiment of a small, streamlined, compact, integrated and durable devices) also serves as an anti-reflux valve between the patient and the urine collection bag, thus preventing drained (and possibly old and unsterile, septic, contaminated) urine from ever re-entering the catheter, urethra, and bladder of the patient, and potentially causing infection or other problems. [0038] The invention can use a manual override for the valves by selectively distancing an externally positioned magnetic members or electret members from the valves that are attracted to it. The override gives flexibility of pressure adjustment and provides the opportunity of assuring full drainage when desired by either physician or the patient. This could manifest itself, in the event of excessive discharge of viscous matter or other mode of lumen blockage, as a “safety” valve to relieve fluid pressure buildup. [0039] The invention can be used as a hospital instrument whenever an indwelling catheter is required, or in clinics, or in physician's offices, or in homes for draining urine from bladders of patients automatically and safely after normal filling, thoroughly and antiseptically. This use is in strong contrast to the typical, non-cyclical, continuous drip associated with urethral catheter drainage into a collection bag. The use of the invention with catheterized patients can help some patients with bladder “retraining” to restore the more normal body function of bladder filling and emptying in a cyclic manner, with normal, healthy pressure sensations in spite of the presence of the catheter which here-tofore prevented “natural” bladder drainage. [0040] A modified urocycler attachment with self-sealing sampling port can be attached to an outer end of most any popular catheter tube. The invention can use extra thin walled catheters, and anti-microbial materials. [0041] Further objects and advantages of this invention will be apparent from the following detailed description of a presently preferred embodiment which is illustrated schematically in the accompanying drawings. BRIEF DESCRIPTION OF THE FIGURES [0042] [0042]FIG. 1A shows a prior art indwelling Foley type catheter with a balloon tipped end. [0043] [0043]FIG. 1B is a cross-sectional view of the catheter of FIG. 1A within the urethra passage. [0044] [0044]FIG. 2 shows a stylette with upwardly protruding threaded tip for use with the invention. [0045] [0045]FIG. 3 shows a catheter having exterior slit(s) and with head member having downwardly protruding threaded portion and fixed interior ring member having interior threads. [0046] [0046]FIG. 4 shows the stylette of FIG. 2 being inserted into the catheter of FIG. 3. [0047] [0047]FIG. 5 shows another view of FIG. 4 with the tip end of the stylette passing through the ring member of the catheter. [0048] [0048]FIG. 6 shows another view of FIG. 5 with the tip end of the stylette located between the ring member and the head member within the catheter. [0049] [0049]FIG. 7 shows a cross-section of the stylette, catheter, ring and head members of FIG. 6. [0050] [0050]FIG. 8 shows another view of FIGS. 6 - 7 with the stylette screwing into the downwardly protruding hollow threaded tip end of the head member. [0051] [0051]FIG. 9 shows another view of FIG. 8 with the tip end of the stylette attached to the head member of the catheter. [0052] [0052]FIG. 10 shows a cross-sectional view of FIG. 9. [0053] [0053]FIG. 11 the head member of FIGS. 9 - 10 after being pulled in the direction of arrow P 1 toward the ring member 80 . [0054] [0054]FIG. 12 is a cross-sectional view of FIG. 11. [0055] [0055]FIG. 13 is another view of the head member of the stylette of FIGS. 11 - 12 being pulled in the direction of arrow P 2 in a final compressed position. [0056] [0056]FIG. 14 is a cross-sectional view of FIG. 13. [0057] [0057]FIG. 15 shows the novel catheter of preceding figures after being inserted into the urethra portion of a bladder. [0058] [0058]FIG. 16A shows another view of the catheter in the bladder of FIG. 15 with the wing portions of the catheter engaged within the bladder. [0059] [0059]FIG. 16B is an enlarged view of the expanded wing portions of the catheter of FIG. 16A. [0060] [0060]FIG. 16C is a cross-section of the urethra and catheter of FIG. 16A in a drainage state. [0061] [0061]FIG. 16D is another cross-section of the urethra and catheter of FIG. 16A in a collapsed non drainage state. [0062] [0062]FIG. 17 is a cross-sectional view of a magnetic cycling piston valve in a closed position in a catheter for controlling bladder drainage. [0063] [0063]FIG. 18A is another view of the valve of FIG. 17 in an open position. [0064] [0064]FIG. 18B is a top view of the valve of FIG. 18A along arrow 18 B. [0065] [0065]FIG. 19 is a cross-sectional view of magnetic cycling funnel/flap valve in a closed position within a catheter for controlling bladder drainage. [0066] [0066]FIG. 20 is another view of the valve of FIG. 19 in an open position. [0067] [0067]FIG. 21 is a cross-sectional view of an electret cycling valve in a closed position within a catheter for controlling bladder drainage. [0068] [0068]FIG. 22 is another view of the valve of FIG. 21 in an open position. [0069] [0069]FIG. 23 shows a top view of an urocycler embodiment for use with the novel catheter tube. [0070] [0070]FIG. 24A is a side cross-sectional view of the urocycler embodiment of FIG. 23. [0071] [0071]FIG. 24B is a cross-sectional view of the embodiment of FIG. 24A along arrow 24 B. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0072] Before explaining the disclosed embodiments of the present invention in detail it is to be understood that the invention is not limited in its application to the details of the particular arrangement shown since the invention is capable of other embodiments. Also, the terminology used herein is for the purpose of description and not of limitation. [0073] This invention is a Continuation-In-Part of U.S. application Ser. No. 10/010,534 filed Dec. 7, 2001, which is incorporated by reference. [0074] Expanding End of Catheter with Stylett Embodiment [0075] [0075]FIG. 2 shows a stylette 50 with an upwardly protruding tip end 56 having a threaded upper surface 57 and upper surface base portion 58 that can be used with the subject invention. Stylette 50 can include a longitudinal portion 54 , and a lower end 52 that can be grabbed by the practitioner using the stylette 50 . The Stylette 50 can be formed from a semi-rigid wire type material such as but not limited to metal wire, plastic, combinations, thereof, and the like. [0076] [0076]FIG. 3 shows a catheter 60 having exterior slit(s) 65 and with head member portion 70 in the upper end 66 of the catheter 60 having downwardly protruding threaded portion and fixed interior ring member 80 having interior threads 83 . [0077] [0077]FIG. 4 shows the stylette 50 of FIG. 2 being inserted into the catheter 60 of FIG. 3 and moved in the direction of arrow I 1 . FIG. 5 shows another view of FIG. 4 with the tip end 56 of the stylette 50 being moved in the direction of arrow I 2 , passing through the ring member 80 of the catheter. FIG. 6 shows another view of FIG. 5 with the tip end 56 of the stylette 50 located between the ring member 80 and the head member 70 passing in the direction of arrow I 3 within the catheter 60 . FIG. 7 shows a cross-section of the stylette 50 , catheter 60 , ring member 80 and head member 70 of FIG. 6. [0078] [0078]FIG. 8 shows another view of FIGS. 6 - 7 with the tip end 56 and threaded portion 57 of the stylette 50 screwing into the downwardly protruding hollow threaded tip end 75 of the head member 70 in the catheter 60 by rotating in a clockwise direction R 1 . [0079] [0079]FIG. 9 shows another view of FIG. 8 with the tip end base portion 58 of the stylette 50 attached to the head member 70 of the catheter 60 , where the base portion 58 having a wider diameter than the outer diameter of the inwardly facing threaded portion 77 that it abuts against the lower portion thereof. FIG. 10 shows a cross-sectional view of FIG. 9. Referring to FIGS. 9 - 10 , the head member 70 can include two parts a partially freely rotatable portion 71 , 74 , 77 , and a fixed ring portion 78 the latter of which can be fixably attached(adhered) to the inner walls of the upper end 66 of the catheter tube 60 . Upper and lower ledges 71 , 77 allow for some rotation of central member 71 , 72 , 74 , and 77 . [0080] During use of the novel catheter assembly, the catheter 60 with internal attached stylette 50 can be inserted into a urethra portion of the bladder of a patient that is going to be catheterized(which will be described in detail in reference to FIGS. 15 , 16 A- 16 C). [0081] [0081]FIG. 11 the head member 70 of FIGS. 9 - 10 after being pulled by the base portion 52 of the stylette 50 in the direction of arrow P 1 toward the ring member 80 . FIG. 12 is a cross-sectional view of FIG. 11. The slits ( 65 , 66 shown in FIGS. 3 - 4 ) in the sides of the catheter 60 expand outward and form wing portions 68 [0082] [0082]FIG. 13 is another view of the head member 70 of the stylette 50 of FIGS. 11 - 12 being pulled in the direction of arrow P 2 in a final compressed position. FIG. 14 is a cross-sectional view of FIG. 13. The stylette 50 can be rotated in a counter-clockwise direction as shown by arrow R 2 , allowing the lower external threaded surface 73 of the head member 70 to rotate within the internal threaded walls 83 of ring member 80 , the latter of which is fixably attached to the inside of the catheter tube 60 . After the head member 70 as become lockably attached to ring member 80 , the upper threaded tip portion 57 of the stylette 50 can be further rotated in the direction of arrow R 2 allowing the stylette 50 to become separated from the both the head member 70 and ring member 80 and then pulled in the direction of arrow P 3 out from the opposite end 62 of the catheter tube 60 . [0083] [0083]FIG. 15 shows the novel catheter 60 of preceding figures after being inserted into the urethra portion 14 of a bladder 10 . Here, the stylette 50 is part of the catheter 60 . [0084] [0084]FIG. 16A shows another view of the novel catheter 60 in the bladder of FIG. 15 with the wing portions 68 ′ of the catheter 60 expanded within the bladder. FIG. 16B is an enlarged view of the expanded wing portions 68 ′ of the catheter 60 of FIG. 16A. As previously described in reference to FIGS. 13 - 14 , the stylette 50 is removed before the catheter tube 60 is used for bladder drainage status. [0085] [0085]FIG. 16C is a cross-section of the urethra 14 and catheter 60 of FIG. 16A while the catheter tube 60 is being used in a drainage state. As shown the urethra 14 is temporarily in an open fluid passage state. [0086] [0086]FIG. 16D is a cross-section of the urethra 14 and catheter tube 60 of FIG. 16A while the catheter tube 60 ′ is in a collapsed non drainage state within the urethra 14 ′. The catheter tube 60 ′ conforms to a closed passageway 15 ′ of closed urethra 60 ′. [0087] Referring to FIGS. 16 C- 16 D, these views further detail the thinner catheter tube 60 that can be used instead of the thick walled catheter tube (5 shown in FIG. 1B) of the prior art. The novel catheter tube can have an outer diameter of approximately ¼ of an inch with a wall thickness of approximately 0.0055 inches, thus allowing for almost an approximate ¼ inch inner diameter flow through portion for the catheter tube 60 . Unlike the thick walled limited drainage passageways, of the prior art, the novel catheter tube 60 more closely approximates the natural diameter size passageway 15 of the urethra 14 . [0088] Additionally, unlike the prior art, the novel catheter 60 of the subject invention can conform to a closed passageway 15 ′ of a closing state urethra 60 ′. Thus, the subject invention does not continuously stretch the urethra, nor cause continuous pain to the catheterized patient, nor cause all the other negative effects by known types of catheters that were described in the background section of the subject invention. [0089] Magnetic Cycling Valves [0090] [0090]FIG. 17 is a cross-sectional view of a first embodiment 100 of a magnetic cycling piston valve 130 in a closed position in a catheter 60 for controlling bladder drainage. FIG. 18A is another view of the valve 130 of FIG. 17 in an open position. FIG. 18B is a top view of the retainer 132 of the valve 130 of FIG. 18A along arrow 18 B. [0091] Referring to FIGS. 17 and 18A- 18 B, an upper nonmagnetic ring member 110 such as flexible plastic, and the like, can be fixably attached to an inner wall 61 of the catheter tube 60 , the latter of which can be the catheter tube 60 described in reference to the preceding figures. Lower ring 120 can be a flexibly pliable permanent magnetic ring hat is fixably attached to the inner wall 61 of the catheter tube 60 beneath the nonmagnetic ring 110 . The moveably piston 130 can include a thin retainer portion 132 such as a single perpendicular portion having one or two ends which can rest on the top 112 of upper ring 110 . As shown in FIG. 18B, the retainer 132 is thin enough to allow fluid to pass about the retainer through the openings defined by the ring members 110 , 120 . The ring member 110 , 120 used can have thin wall thicknesses so as not to obstruct the passageway formed by the inner walls 61 of the catheter tube 60 . Attached perpendicular to and extending below retainer 132 can be a thin longitudinal shaft 134 such as a flexible plastic strip, and the like. Attached beneath shaft 134 can be a stopper 136 formed from a magnetic material that is attracted to lower magnet ring 120 , or a metal material that is attracted to lower magnetic ring 120 , and the like. Alternatively, the stopper 136 can be a magnetic material and the lower ring member 120 can be a metal material that are attracted to each other. Inwardly slanting sides 137 on the stopper 136 can allow for the stopper 136 to be substantially sealed against the opening in lower ring member 120 . [0092] Referring to FIGS. 17 and 18A- 18 B, in operation fluid flowing in the direction of arrow F 1 can push the stopper 136 in a downward direction as shown by arrow M 1 causing the stopper 137 to separate from the lower ring member 120 . The magnetic attraction of the lower ring member 120 and stopper 132 can be calibrated to be approximately equal to natural bladder drainage pressure flows. For example, approximately 0.1 ounces per square feet or approximately 15 cm height of H2O fluid in the catheter tube 60 can be calibrated to be enough to push open the seated stopper 36 of FIG. 17 to the positions shown in FIG. 18A. [0093] [0093]FIG. 19 is a cross-sectional view of a magnetic cycling embodiment 200 using a funnel/flap valve 201 in a closed position within a catheter 60 for controlling bladder drainage. FIG. 20 is another view of the valve 201 of FIG. 19 in an open position. [0094] Referring to FIGS. 19 - 20 , magnetic valve embodiment 200 can include a pliable thin walled ring member 210 , such as pliable plastic and the like, fixably attached to an inside wall portion 61 of the novel catheter tube 60 . Attached to an extending downward from the ring member 210 can be funnel portions 220 , 230 that can be formed from two thin pliable flaps having a lower end portions with small pliable type magnets 225 , 235 attached thereto that be attracted to each other closing off the passageway formed from the opening through ring member 210 which can give the appearance of a funnel shape, and the like. Alternatively, the funnel portions 220 , 230 can be single pliable cylindrical chamber such as thin walled plastic, a plastic bag, and the like, that can have a wall thickness of approximately 0.001 inches, and the like. Although two magnets 125 , 135 are described, the invention can be used with one magnet 125 and a portion 135 having metal attributes and the like. Similar to the preceding embodiment, the ring member 210 and funnel portions 220 , 230 can include thin enough walls not to reduce the opening formed by the inner walls 61 of the catheter tube 60 . The magnetic attraction of the portions 225 , 235 of the funnel portions 220 , 230 can be calibrated to be approximately equal to natural bladder drainage pressure flows. For example, approximately 0.1 ounces per square feet or approximately 15 cm height of H2O fluid in the catheter tube 60 pushing in the direction of arrow F 2 can be calibrated to be enough to push open the funnel of FIG. 19 to the positions shown in FIG. 20. [0095] Electret Cycling Valve [0096] [0096]FIG. 21 is a cross-sectional view of an electret cycling valve embodiment 300 in a closed position within a catheter 60 for controlling bladder drainage. FIG. 22 is another view of the valve 301 of FIG. 21 in an open position. Here a pliable thin walled ring member 310 can be fixably attached to an inner wall surface 61 of catheter tube 60 . Extending below ring member 310 can be two electret material sheets 320 , 330 such as flexible plastic sheets imbedded with electric charges. For example, sheet 320 can include a positive charge on the inner surface of lower end 322 and sheet 330 can include a negative charge an inner surface of lower end 332 . Similar to the preceding embodiment the sheets 320 , 330 can form a funnel shape that can open and close the passageway formed by inner walls 61 of the catheter tube 60 . The electret attraction of the portions 322 , 332 of the funnel portions 320 , 330 can be calibrated to be approximately equal to natural bladder drainage pressure flows. For example, approximately 0.1 ounces per square feet or approximately 15 cm height of H2O fluid in the catheter tube 60 pushing in the direction of arrow F 3 can be calibrated to be enough to push open the funnel of FIG. 21 to the position shown in FIG. 22. [0097] External Urocycler Embodiment [0098] [0098]FIG. 23 shows a top view of a urocycler embodiment 400 for use with the catheter tube 60 of the preceding figures. FIG. 24A is a side cross-sectional view of the urocycler embodiment 400 of FIG. 23. FIG. 24B is a cross-sectional view of the embodiment 400 of FIG. 24A along arrow 24 B. [0099] Embodiment 400 can use the urocycler components described in parent U.S. application Ser. No. 10/010,534 filed Dec. 7, 2001, which is incorporated by reference, and can include inlet barbed connector 402 and outlet barbed connector 404 attached to opposite ends of main nonmagnetic housing 420 , the latter of which can have a male pronged end 424 which snapably and sealingly attaches to a female prong end 422 . A vent hole port 426 can be located on the downstream end of male housing portion 424 . Inside the upstream portion 422 of housing 420 can be a fixed valve member 432 being formed of a magnetic member, and the like, fixed in position adjacent to a hollow valve port ring 434 whose center flow passageway can be opened and closed by moveable valve member 438 with resilient valve seat 436 which can move forward and backward in the direction of double arrow MG along inner channel rails 439 so as to open and close the valve in a cycling manner similar to those embodiments previously described. [0100] A manual override for the valves can be accomplished by selectively distancing an externally positioned magnetic member 440 from the moveable magnet member 438 . The override gives flexibility of pressure adjustment and provides the opportunity of assuring full drainage when desired by either physician or the patient. This could manifest itself, in the event of excessive discharge of viscous matter or other mode of lumen blockage, as a “safety” valve to relieve fluid pressure buildup. This override feature can be used with the previous embodiments by using either an external magnet or an external electret member. [0101] This urocycler embodiment can include a novel sampling port 410 formed about a port housing 412 , with an inner port surface having with inwardly protruding steps 415 so that a like sized and fitted elastomer shaped plug member 411 can be mateably attached thereto. Port 410 can include an elastomer plug shape that is continuously self-sealing after being punctured by needles and the like. In operation, a practitioner can attach the inlet barbed connector 402 to the exposed lower conical shaped end ( 69 for example in FIG. 15) of the catheter tube 60 , and the barbed outlet port 404 of embodiment 400 to a collection bag, and the like. During a urine drainage cycle, the practitioner can swab the outside surface of the elastomeric plug shaped membrane 410 with an antiseptic, and the like. A needle(cannula) or syringe or other sampling device can be inserted through the center of the sampling port 410 and a fresh sample of urine can be drawn. After which, the syringe/cannular can be withdrawn, the self-sealing elastomeric plug becomes sealed again, and the sampling port 410 can be swabbed with antiseptic. [0102] Anti-microbial Catherter Materials [0103] The catheter can include an anti-microbial surface such as an interior coating and/or outside coating. Alternatively, the ant-microbial surface can be caused from an impregnated material which leaches to either or both the inside and/or the outside of the catheter tube. The anti-microbial surface and be an anti-bacterial material, and/or a hydrophyllic material that is compatible with the skin and will not support bacterial growth. Materials that can be used include but are not limited to silver alloy, and the like. [0104] Although the catheter tube 60 is described as being used with the magnetic cyclers of the preceding figures, the novel magnetic cyclers can be used inside other types of catheter tubes such as those described in the background section of the invention. [0105] Although the invention describes the catheters for use as a suprapubic type by passing through the urethra, the invention can be used with other types of catheter uses such as but not limited to renal catheters, cardiology catheters, and the like. [0106] While the invention has been described, disclosed, illustrated and shown in various terms of certain embodiments or modifications which it has presumed in practice, the scope of the invention is not intended to be, nor should it be deemed to be, limited thereby and such other modifications or embodiments as may be suggested by the teachings herein are particularly reserved especially as they fall within the breadth and scope of the claims here appended.

1a

[0001] The present invention relates to a winch for raising and lowering persons, comprising a housing provided with a first attachment member, a first opening formed in the housing substantially opposite to the first attachment member, an electric motor coupled to the input of a reduction gearing, a reel component coupled to the output of the reduction gearing, and a flexible elongated traction member connected to the reel component for winding and unwinding the traction member for raising and lowering a person. Further, the invention relates to the use of a winch according to the invention as a ceiling lift. The invention also relates to a ceiling lift assembly, comprising an overhead rail with at least one carriage guided therein, the carriage being provided with an attachment member, a winch provided with at least one attachment member on the winch housing and the winch comprising a flexible elongated traction member with an attachment member on its free end and a spreader bar with an attachment member. BACKGROUND ART [0002] U.S. Pat. No. 6,085,368 discloses a winch of the above type, that is used as a ceiling lift. Ceiling lifts have the advantage with respect to floor lifts with a mast and a lifting arm arrangement that they do not occupy any floor space. In certain rooms the ceiling lift may only be used on relatively few occasions, and it would be inefficient to keep a winch in such a room continually. Installing winches in a room only for periods of time when they are in use is not an attractive alternative because disengaging conventional hoists from a rail in a first room and engaging the hoist to a rail in another room is a cumbersome process, that often requires the use of special tools. [0003] The rails for ceiling lifts are normally not continuous from one room to another. Moving a lifted person from between rooms that are not joined by a rail, e.g. through a door opening is very complicated or impossible with most conventional hoists. Conventional winches can usually only be operated in one orientation, i.e. the winch can either only be used in the “overhead” orientation where the winch housing is directly suspended from the rail with the spreader bar or other application suspended from the end of the extendable strap or cable, or the winch can only be used in the “upside down” orientation with the winch suspended from the rail via the extendable strap or cable whose free end is connected to the rail and the spreader bar is suspended from the winch housing. The optimum working position and orientation of the winch depends however on circumstances and none of the available prior art winches is flexible in this respect. DISCLOSURE OF THE INVENTION [0004] Against this background, it is an object of the present invention to provide a winch of the kind referred to initially, which overcomes or at least reduces the above mentioned problems by allowing it to operate in a plurality of orientations. This object is achieved in accordance with claim 1 by providing a winch of said kind with the housing having a second opening so that the traction member can be guided through the first opening or through the second opening. [0005] Thus, it becomes possible to operate the winch in more orientations. [0006] The second opening can be formed in a face of the housing that is substantially at right angles with the face of the housing in which the first opening is formed. [0007] Thus, it becomes possible to operate the winch in four distinct orientations, namely: in the overhead orientation with the first attachment member connected to the rail, the traction member guided through the first opening in the housing and the free end of the traction member being connected to the load, in the upside down orientation with the first attachment member connected to the load, the traction member guided through the first opening in the housing and the free end of the traction member being connected to the rail, in the overhead orientation with the second attachment member connected to the rail, the traction member guided through the second opening in the housing and the free end of the traction member being connected to the load, in the upside down orientation with the second attachment member connected to the load, the traction member guided through the second opening in the housing and the free end of the traction member being connected to the rail. [0012] The winch may comprise a second attachment member positioned substantially opposite to the second opening. [0013] The first and/or second attachment member may form part of a quick release coupling system, preferably a system of the bayonet type. [0014] The traction member may pass over a spring biased excenter shaft operatively connected with a switch that changes state when the load on the traction member exceeds a given threshold and thereby urges the excenter shaft to rotate against the spring bias. [0015] It is another object of the present invention to provide a winch of the kind referred to initially, which is more flexible in use. This object is achieved in accordance with claim 6 by providing a winch of said kind in which the one or more attachment members form part of a quick release fastening system, preferably a system of the bayonet type. [0016] Thus, the winch can be connected conveniently to rails, spreader bars, lifting straps and other suspension members. [0017] Preferably, the one or more attachment members are provided with an electronic safety switch that is activated when a complementary part of the quick release fastening system is properly engaged with the attachment member concerned. [0018] The free end of the traction member preferably comprises an attachment member, and the winch preferably comprises two attachment members. [0019] It is another object of the present invention to provide a ceiling lift assembly of the kind referred to that is more flexible in use. This object is achieved in accordance with claim 9 by providing a winch assembly of said kind in which the attachment members are part of an interchangeably quick release coupling system. Thus the complete ceiling lift assembly can be quickly assembled and disassembled to move location, or to change operating position and orientation as different circumstances may require. [0020] It is yet another object of the present invention to provide a winch of the kind referred to initially, with an improved mechanism for preventing operation of the electric motor when the traction member is not tensioned by a load. This object is achieved in accordance with claim 13 by providing a winch of said kind in which the traction member passes over a spring biased excenter shaft operatively connected with a switch that changes state when the load on the traction member exceeds a given threshold and thereby urges the excenter shaft to rotate against the spring bias. [0021] The excenter shaft is preferably provided with an arm extending substantially perpendicular to the excenter shaft with the free end of the arm acting on the switch. [0022] Further objects, features, advantages and properties of the mobile winch and use of the winch according to the invention will become apparent from the detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [0023] In the following detailed portion of the present description, the invention will be explained in more detail with reference to the exemplary embodiments shown in the drawings, in which [0024] FIG. 1 is a perspective view of a winch according to the invention just before attaching it to an overhead rail, [0025] FIG. 2 is a perspective view of a winch according to the invention while attaching it to an overhead rail, [0026] FIG. 3 is a perspective view of a winch according to the invention when it is securely attached an overhead rail, [0027] FIG. 4 is a detailed perspective view from below on an upside down mounted winch according to the invention with a spreader bar directly attached to it, [0028] FIG. 5 is a detailed perspective cut-open view from above of an upside down mounted winch of FIG. 5 , [0029] FIG. 6 is a view of a spreader bar and a free end of a strap with a quick coupling system according to the invention, [0030] FIG. 7 is a view of a ceiling lift according to the invention with an overhead mounted winch in a horizontal orientation, [0031] FIG. 8 is a view of a ceiling lift according to the invention with an overhead mounted winch in a vertical orientation, [0032] FIG. 9 is a view of a ceiling lift according to the invention with an upside down mounted winch in a horizontal orientation, [0033] FIG. 10 is a view of a ceiling lift according to the invention with an upside down mounted winch in a vertical orientation, [0034] FIGS. 11 to 14 illustrate step by step the procedure of passing though a door opening with the winch assembly according to the invention where the rail is interrupted, [0035] FIG. 15 is a detailed view of the bayonet type quick coupling of the winch and ceiling lift according to the invention, [0036] FIGS. 16 and 17 illustrate the engagement procedure of the quick coupling, [0037] FIG. 18 is a view of a load detection system according to the invention, and [0038] FIGS. 19 and 20 are detailed views of the load detection system. DETAILED DESCRIPTION [0039] A ceiling lift 1 according to a preferred embodiment of the invention is illustrated in FIG. 1 . The ceiling lift 1 incorporates an overhead rail 2 that is mounted adjacent to the ceiling. The rail 2 can be mounted on a lift structure or alternatively be mounted to the ceiling. A carriage (not shown) with a downward projection 5 is guided in the overhead rail 2 . [0040] A discus shaped winch 6 is ready to be attached to the downward projection 5 at a connection point formed by first female seat 16 . The first female seat 16 and the downward projection 5 form a quick coupling of the bayonet type that will be described in more detail further below. [0041] The housing of the winch 6 is formed by a first convex side panel 20 and a second convex side panel 21 that are interconnected by a rim 22 . Two recesses in the winch housing allow two diametrically opposite parts of the circumference of the rim 22 serve as handles 23 . [0042] A lifting strap 7 projects from a first opening 17 ( FIG. 5 ) in the first convex side panel 20 . A second opening 19 through which the strap 7 can leave the housing is provided in the rim 22 . The free end 9 of the lifting strap 7 is attached to a spreader bar 10 . The extremities of the spreader bar 10 are provided with hooks for attaching a sling or the like (not shown) holding the patient to be lifted. [0043] FIG. 2 shows the winch 6 with the first female seat 16 placed over the downward projection 5 . FIG. 3 shows the winch secured by rotating it 90° relative to the orientation in FIG. 2 about the vertical axis to engage the bayonet coupling. A second female seat 18 , disposed diametrically opposite to the second opening 19 can now be seen. The operating position of the winch 6 to the carriage in the rail as in FIGS. 1 to 3 will in the following be referred to as “overhead mounted”. [0044] FIG. 4 shows the winch 6 from below. The free end of the strap 7 is connected to the projection 5 of the carriage in the rail 2 . The winch 6 is thus suspended from the strap 7 . The spreader bar 10 is directly connected to the winch 6 at the first female seat 16 . The operating position of the winch as in FIG. 4 will in the following be referred to as “upside down mounted”. [0045] FIG. 5 shows the winch 6 from above with the first convex side panel 20 removed. The strap 7 is guided through the first opening 17 which is provided with a lug 25 on each side. Inside the housing the winch 6 is provided with a support structure with two parallel transverse plates 26 . A reel 27 for winding and unwinding the strap 7 is rotably engaged between the transverse plates 26 . The reel 27 is connected to the output of a straight reduction gearing 28 which is in turn connected to the output of a worm drive 29 . The worm drive 29 is driven by an battery powered electric motor 30 . The electric motor 30 , the worm gear 29 and the reduction gearing 38 are arranged in a compartment 31 next to the support structure. The batteries (not shown) are received in a compartment 32 on the opposite side of the support structure, thus giving the winch 6 a substantially equal weight distribution. The strap 7 can be completely rolled up onto the reel and paid out through the second opening 19 , so that the winch may be used in another orientation. When the strap 7 extends though the first opening 17 the winch can be used in the “horizontal” position as illustrated in FIGS. 1 to 7 . When the strap 7 extends though the second opening 19 the winch 6 can be used in the “vertical” position as illustrated in FIGS. 9 and 10 . Each of these orientations has its advantages, and the optimum choice of operating position depends on circumstances. [0046] FIG. 6 shows a detail of the quick coupling system of the spreader bar 10 and the free end 9 of the strap 7 . A male part 33 the bayonet type quick coupling system extends upward from the spreader bar 10 . The free end 9 of the strap is provided with a seat 35 that incorporates the female part of the bayonet type quick coupling system. Connecting the spreader bar 10 to the free end 9 of the strap 7 is thus merely a matter of inserting the male part 33 into the female seat 35 and turning the seat 35 and the spreader bar 90° relative to one another. The quick coupling system is interchangeable throughout the ceiling lift, i.e. the male parts 5 and 33 fit to all female seats 16 , 18 and 35 . [0047] FIGS. 7 to 10 show the ceiling lift 1 in different operating positions and orientations. In FIG. 7 the winch 6 is overhead mounted and the housing is in the horizontal orientation. This operating position gives a high maximum lifting height and the winch 6 itself is always far from the head of the patient. The winch 6 has however to be lifted up to the ceiling for mounting it with the first female seat 16 to the projection 5 of the carriage in the rail 2 . [0048] In FIG. 8 the winch 6 is mounted upside down and the housing is in the horizontal orientation. This operating position gives also a high maximum lifting height. The winch 6 can be mounted to the rail 2 by extending the strap 7 and engaging the female seat 35 on the free end 9 of the strap to the projection 5 of the carriage in the rail 2 . Then the winch 6 is activated to wind the strap 7 to lift the winch with the spreader bar 10 attached thereto. In this operating position the winch 6 itself is however always close to the head of the patient which could be experienced as an inconvenience. This operating position is particularly suitable for transfer between rooms that are not joined by a rail, as will be set out in detail below [0049] In FIG. 9 the winch 6 is overhead mounted and the housing is in a vertical orientation. This operating position gives a somewhat reduced maximum lifting height but the winch 6 itself is always far from the head of the patient. The winch 6 has however to be lifted up to the ceiling for mounting it with the first female seat 16 to the projection 5 of the carriage in the rail 2 . [0050] In FIG. 10 the winch 6 is upside down mounted and the housing is in a vertical orientation. This operating position gives a somewhat reduced maximum lifting height. The winch 6 can be mounted to the rail 2 by extending the strap 7 and engaging the female seat 35 on the free end 9 of the strap to the projection 5 of the carriage in the rail 2 . Then the winch 6 is activated to wind the strap 7 to lift the winch with the spreader bar 10 attached thereto. In this operating position the winch itself is always near to the head of the patient but since it extends mainly vertically this is usually not experienced as an inconvenience. [0051] FIGS. 11 to 14 illustrate step by step the procedure of passing though a door opening. The lift is to be transferred from the rail 2 to a second rail 102 in an adjacent room. In FIG. 11 the operating position at the start of the procedure is the same as in FIG. 8 . The free end 9 of the strap 7 is attached to the carriage in the rail 2 left to the wall 34 separating the two adjacent rooms. The door opening through which the lift with or without a patient should pass is below the wall 34 . A second non-windable strap 107 has one of its ends hooked to one of the a lugs 25 , and its other end connected to a carriage in the rail 102 . In the next step ( FIG. 12 ) the strap 7 is carefully unwound and the load gradually transfers to strap 107 . Next ( FIG. 13 ), the free end 9 of the strap 7 is detached from the carriage in rail 2 and reconnected to a carriage in rail 102 . Then, strap 7 is wound until the load transfers back to it and when the strap 107 is no longer carrying any load it is removed ( FIG. 14 ) and the procedure is complete. The procedure is facilitated by the use of the quick coupling system. [0052] FIGS. 15 to 17 illustrate in detail the bayonet type quick coupling system according to a preferred embodiment of the invention and its operation. In FIG. 15 the male part 5 , 34 provided with two diametrically opposite redial protrusions 37 is placed just in front of the female seat 16 , 18 , 35 for insertion. The female seat 16 , 18 , 35 is provided with a slot 36 suited for receiving the male part 5 , 33 in the orientation shown. To engage the coupling, the male part 5 , 33 is fully inserted into the slot 36 ( FIG. 16 ) and turned 90° relative to the female seat 16 , 18 , 35 ( FIG. 17 ) and then released. The female seat is provided with two abutment blocks 38 that allow rotation in only one direction when the male part 5 , 34 has just been inserted into the slot 36 . A notch 39 in the female seat for receiving the protrusions 37 extends to both sides of the slot 36 . The protrusions 37 are securely locked into the notch 39 when a load is applied to the male part 5 , 34 . In order to further improve safety, a micro switch 40 is arranged partially in the notch 39 such that it changes state when the protrusions 37 engage properly into the notch 39 . The micro switch 40 is connected to an electronic control unit 60 ( FIG. 18 ) that controls operation of the electric motor 30 . When the switch is not actuated by a protrusion 37 the control unit prevents any winding or unwinding for safety reasons. [0053] FIGS. 18 to 20 show the details of the system in the winch 6 that prevents inadvertedly winding or unwinding of the strap 7 when there is no load on the strap 7 . FIG. 18 shows a cut open side view on the interior of the winch. The strap 7 extends from the reel 27 , passes over an excenter shaft 50 and leaves the winch 6 through the first opening 17 . The excenter shaft 50 is spring biased and provided with a radially extending arm 51 that actuates a micro switch 55 . Tension in the strap 7 urges the excenter shaft 50 to rotate against the spring bias and the radial arm rotates in unison with the excenter shaft. Thus, the switch changes state when a load above a preset threshold is applied to the strap 7 . The micro switch 55 is connected to the electronic control unit 60 . The electronic control unit 60 prevents winding and unwinding of the strap when no load on the strap 7 can be detected. Thus, inadvertedly winding or unwinding an unloaded strap is avoided. The winch 6 is also provided with an excenter shaft 50 , radial arm 51 and micro switch 55 at the second opening 19 from which the strap can leave the winch ( FIG. 19,20 ). [0054] Although the present invention has been described in detail for purpose of illustration, it is understood that such detail is solely for that purpose, and variations can be made therein by those skilled in the art without departing from the scope of the invention. [0055] Thus, while the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Other embodiments and configurations may be devised without departing from the scope of the appended claims. ? [0056] FIG. 5 shows the winch 6 from above with the first convex side panel 20 removed. The strap 7 is guided through the first opening 17 which is provided with a lug 25 on each side. Inside the housing the winch 6 is provided with a support structure with two parallel transverse plates 26 . A reel 27 for winding and unwinding the strap 7 is rotatably rotably engaged between the transverse plates 26 . The reel 27 is connected to the output of a straight reduction gearing 28 which is in turn connected to the output of a worm drive 29 . The worm drive 29 is driven by a an battery powered electric motor 30 . The electric motor 30 , the worm gear 29 and the reduction gearing 28 are arranged in a compartment 31 next to the support structure. The batteries (not shown) are received in a compartment 32 on the opposite side of the support structure, thus giving the winch 6 a substantially equal weight distribution. The strap 7 can be completely rolled up onto the reel and paid out through the second opening 19 , so that the winch may be used in another orientation. When the strap 7 extends though the first opening 17 the winch can be used in the “horizontal” position as illustrated in FIGS. 1 to 7 . When the strap 7 extends though the second opening 19 the winch 6 can be used in the “vertical” position as illustrated in FIGS. 9 and 10 . Each of these orientations has its advantages, and the optimum choice of operating position depends on circumstances. [0057] Please replace the paragraph starting at Page 11 , line 30 , with the following paragraph: [0058] FIGS. 18 to 20 show the details of the system in the winch 6 that prevents inadvertently winding or unwinding of the strap 7 when there is no load on the strap 7 . FIG. 18 shows a cut open side view on the interior of the winch. The strap 7 extends from the reel 27 , passes over an excenter shaft 50 and leaves the winch 6 through the first opening 17 . The excenter shaft 50 is spring biased and provided with a radially extending arm 51 that actuates a micro switch 55 . Tension in the strap 7 urges the excenter shaft 50 to rotate against the spring bias and the radial arm rotates in unison with the excenter shaft. Thus, the switch changes state when a load above a preset threshold is applied to the strap 7 . The micro switch 55 is connected to the electronic control unit 60 . The electronic control unit 60 prevents winding and unwinding of the strap when no load on the strap 7 can be detected. Thus, inadvertently winding or unwinding an unloaded strap is avoided. The winch 6 is also provided with an excenter shaft 50 , radial arm 51 and micro switch 55 at the second opening 19 from which the strap can leave the winch ( FIG. 19,20 ).

1a

PRIORITY CLAIM [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/870,849, entitled “Methods, Systems and Devices for Improving Ventilation in a Lung Area”, filed Jun. 17, 2004, which claims priority to U.S. provisional patent application Ser. No. 60/479,213, filed Jun. 18, 2003, the disclosures of each of which are incorporated herein by reference in their entireties. [0002] This application is also a continuation-in-part of U.S. patent application Ser. No. 10/771,803, entitled “Tracheal Catheter and Prosthesis and Method of Respiratory Support of a Patient”, filed Feb. 4, 2004, which claims priority to German patent application Serial Number 20/40963-001 filed Aug. 11, 2003, the disclosures of each of which are incorporated herein by reference in their entireties. [0003] This application is also a continuation-in-part of U.S. patent application Ser. No. 10/576,746, entitled “Tracheal Catheter and Prosthesis and Method of Respiratory Support of a Patient Airway Prosthesis and Catheter”, filed Feb. 10, 2006, which is a national stage application of PCT patent application PCT/DE2004/001646, entitled “Method and Arrangement for Respiratory Support for a Patient Airway Prosthesis and Catheter”, filed Jul. 23, 2004, and which in turn claims priority to German patent application Serial Number 103 37 189.9, filed Aug. 11, 2003, the disclosures of which are incorporated herein by reference in their entireties. [0004] This application also claims priority to U.S. provisional application Ser. No. 60/835,066, entitled “Methods and Devices for Minimally Invasive Respiratory Support”, filed Aug. 3, 2006, the disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0005] This invention relates to ventilation therapy and oxygen therapy for persons suffering from respiratory impairment, such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and acute respiratory distress syndrome (ARDS). BACKGROUND OF THE INVENTION [0006] The following documents may be considered related art: Patent Application PCT/DE2004/001646, Freitag, L; Method and arrangement for respiratory support for a patient airway prosthesis and catheter U.S. Patent Application 20050005936, Wondka; Methods, systems and devices for improving ventilation in a lung area U.S. Pat. No. 5,419,314, Christopher; Method and apparatus for weaning ventilator-dependent patients U.S. Patent Application 20050247308, Frye, Mark R.; High efficiency liquid oxygen system U.S. Pat. No. 4,938,212, Snook; Inspiration oxygen saver Transtracheal Open Ventilation in Acute Respiratory Failure Secondary to Severe Chronic Obstructive Pulmonary Disease Exacerbation American Journal of Respiratory and Critical Care Medicine Vol 173. pp. 877-881, (2006), Cesare Gregoretti Preliminary observations of transtracheal augmented ventilation for chronic severe respiratory disease. Respir Care. 2001 January; 46(1):15-25, Christopher K L Reduced inspiratory muscle endurance following successful weaning from prolonged mechanical ventilation. Chest. 2005 August; 128(2):553-9 Chest. 2005 August; 128(2):481-3. Chang A T A comparison in a lung model of low- and high-flow regulators for transtracheal jet ventilation. Anesthesiology. 1992 July; 77(1):189-99. Gaughan S D, Benumof J L Tracheal perforation. A complication associated with transtracheal oxygen therapy. Menon A S— Chest— 1 Aug. 1993; 104(2): 636-7 Dangerous complication of transtracheal oxygen therapy with the SCOOP® system. Rothe T B— Pneumologie— 1 Oct. 1996; 50(10): 700-2 [0018] Patients suffering from respiratory impairment are under-oxygenated due to deteriorating lung structure and are fatigued due to the strenuous work required to get air in and out of their compromised lungs. This work leads to patients becoming dormant to reduce their oxygen consumption to reduce their work of breathing (WOB) and in turn this dormancy leads to other health problems. Long term oxygen therapy (LTOT) is a gold standard therapy widely used for decades to assist patients suffering from respiratory impairment. Typically patients are provided 1-6 LPM of continuous oxygen flow into the nose via an oxygen nasal cannula. The supplemental oxygen increases the concentration of oxygen in the lung and alveolii therefore increasing the oxygen delivered to the body thus compensating for the patient's poor lung function. Improvements to LTOT have been more recently introduced such as transtracheal oxygen therapy (TTOT) and demand oxygen delivery (DOD). TTOT (U.S. Pat. No. 5,419,314) is a potential improvement over LTOT in that the oxygen is delivered directly to the trachea thus closer to the lung and thus the oxygen is not wasted in the upper airway and nasal cavity. DOD systems (U.S. Pat. No. 4,938,212) have been devised to sense when the patient is inspiring and deliver oxygen only during inspiration in order to conserve the source of oxygen, a concern in the home care or ambulatory setting although not a concern in the hospital setting where the oxygen source is plentiful. LTOT, TTOT and DOD are useful in improving diffusion of oxygen into the tissues by increasing the oxygen level in the lung and bloodstream, but these therapies all have the drawback of not providing any real ventilatory support for the patient and the excessive WOB is not relieved, especially during the types of simple exertion which occur during normal daily activities, like walking or climbing stairs. [0019] Continuous Positive Airway Pressure (CPAP) ventilation has been used extensively to provide ventilatory support for patients when LTOT alone is insufficient to compensate for a patient's respiratory impairment. However, CPAP is non-portable and is obtrusive to patients because of the nasal mask that must be worn. Further, CPAP can inadvertently train the respiratory muscles to become lazy since the neuromuscular system gets acclimated to the artificial respiratory support, a syndrome known within the respiratory medical community. [0020] Transtracheal High Frequency Jet Ventilation (TTHFJV) as described by Benumof has also been used, for example for emergency ventilation, typically using a small gauge catheter introduced into the trachea. Frequencies are typically 60 cycles per minute or greater, driving pressures are typically around 40 psi, and flow rates are typically greater than 10 LMP therefore requiring a blended oxygen air mixture and heated humidification. TTHFJV is not a portable therapy and is not appropriate as a ventilation assist therapy for an ambulatory, spontaneously breathing, alert, non-critical patient. [0021] Transtracheal Open Ventilation (TOV) as described by Gregoretti has been used as an alternative to mechanical ventilation which uses an endotracheal tube. The purpose of TOV is to reduce the negative side effects of invasive ventilation such as ventilator associated pneumonia. Typically a 4 mm catheter is inserted into a tracheostomy tube already in the patient and the other end of the catheter is attached to a conventional mechanical ventilator which is set in assisted pressure control mode and mechanical breaths are delivered into the trachea synchronized with the patients breath rate. However because the ventilator delivers a predetermined mechanical breath set by the user the ventilator is breathing for the patient and is not truly assisting the patient. TOV is non-portable and is designed to provide a high level or complete support of a patients respiration. [0022] Transtracheal Augmented Ventilation (TAV) as described by Christopher is a therapy in which high flow rates typically greater than 10 LPM of a humidified oxygen/air blend are delivered continuously into the trachea or can be delivered intermittently or synchronized with the patients' breathing pattern. TAV is a good therapy to provide ventilatory support for patients with severe respiratory insufficiency, however TAV is not suitable for an ambulatory portable therapy because of the high flow and humidification requirement. [0023] Current oxygen delivery therapies or ventilation therapies are either too obtrusive, or are not sufficiently compact or mobile, or are limited in their efficacy and are therefore not useful for the vast population of patients with respiratory insufficiency that want to be ambulatory and active while receiving respiratory support. Specifically a therapy does not exist which both (1) oxygen delivery to increase oxygen diffusion into the blood stream, and (2) ventilation support to relieve the WOB in a mobile device. The invention disclosed herein provides unique and novel solutions to this problem by providing an unobtrusive, ultra compact and mobile, clinically effective system that provides both oxygen diffusion support and ventilation support to address respiratory insufficiency. SUMMARY OF THE INVENTION [0024] The invention described herein includes s a method and devices wherein both oxygen delivery and ventilatory support are provided by percutaneous, transtracheal, inspiratory-synchronized jet-augmented ventilation (TIJV). The therapy is provided by an ultra compact wearable ventilator and a small gauge indwelling delivery catheter. [0025] Additional features, advantages, and embodiments of the invention may be set forth or apparent from consideration of the following detailed description, drawings, and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed. BRIEF DESCRIPTION OF THE FIGURES [0026] The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate preferred embodiments of the invention and together with the detail description serve to explain the principles of the invention. In the drawings: [0027] FIG. 1 describes graphically the difference between the present invention and the prior art. [0028] FIG. 2 describes comparing two sensors for compensating for drift and artifacts and differentiating the comparison to correlate the signal to the breathing curve. [0029] FIG. 3 graphically describes conventional oxygen therapy [0030] FIG. 4 graphically describes alternative ventilation delivery timing profiles for the present invention. [0031] FIG. 5 describes a special liquid oxygen system for delivering the ventilation therapy of the present invention. [0032] FIG. 6 describes a special liquid oxygen system with multiple outputs for delivering the ventilation therapy of the present invention. [0033] FIG. 7 describes a special compressed oxygen regulator for delivering the ventilation therapy of the present invention. [0034] FIG. 8 describes a special high output oxygen generating system for delivering the ventilation therapy of the present invention. [0035] FIG. 9 describes converting conventional oxygen supplies into a ventilator for delivering the ventilation therapy of the present invention. [0036] FIG. 10 describes a piston and cylinder for amplifying the volume output of the present invention and for achieving a higher mean output pressure. [0037] FIG. 11 describes combining oxygen insuflation of the bronchial tree with the ventilation therapy of the present invention. [0038] FIG. 12 describes the Venturi effect of the present invention. [0039] FIG. 13 describes adjusting the amplitude of the Venturi effect by catheter mechanisms. [0040] FIG. 14 describes oxygen-air blending techniques to deliver different oxygen concentrations to the patient. [0041] FIG. 15 describes use of a pressure amplifier to boost the pressure output of the oxygen source or ventilator. [0042] FIG. 16 describes a dual chamber system which alternates chambers for delivering gas to the patient. [0043] FIG. 17 describes conventional volume and timing control systems and a special timing and volume control system for delivering the ventilation therapy of the present invention in a small and low-electrically powered unit. [0044] FIG. 18 describes a piston system with a spring assisted gas delivery stroke. [0045] FIG. 19 describes a piston for the present invention with an adjustable volume output. [0046] FIG. 20 describes graphically the effect of an augmentation waveform adjustment of the present invention. [0047] FIG. 21 describes exhalation counterflow therapy to reduce collapse of the airways during exhalation, to be used in conjunction with the augmentation therapy of present invention. [0048] FIG. 22 describes tracheal gas evacuation to reduce the CO2 content in the airways, to be used in conjunction with the augmentation therapy of the present invention. [0049] FIG. 23 describes non-cylindrically shaped oxygen gas cylinders or accumulators for use in the present invention. [0050] FIG. 24 describes a 360 degree curved ventilation catheter tip to position gas delivery orifice in the center of the tracheal lumen. [0051] FIG. 25 describes a 540 degree curved ventilation catheter tip to position the gas delivery tip in the center of the tracheal lumen. [0052] FIG. 26 describes a thin wall outer cannula, stomal sleeve and inner cannula which is the ventilation catheter. [0053] FIG. 27 describes a ventilation catheter with a bend shape to position the catheter against the anterior tracheal wall and the tip orifice at a distance from the anterior wall. [0054] FIG. 28 describes a soft ventilation catheter with a stiffening or shaping member inside the catheter. [0055] FIG. 29 describes a ventilation catheter adaptable to a standard respiratory connector. [0056] FIG. 30 describes a ventilation catheter and a catheter guide, where the catheter has a non-obstructing positioning member. [0057] FIG. 31 describes a ventilation catheter with a spacer positioned to locate the catheter tip at a controlled desired distance from the anterior tracheal wall. [0058] FIG. 32 describes a ventilation catheter with a generally right angle curve to position the tip of the catheter in the center of the tracheal lumen. [0059] FIG. 33 describes a ventilation catheter with a compressible stomal tract seal. [0060] FIG. 34 describes a smart ventilation catheter with electronic tags to handshake with the ventilator. [0061] FIG. 35 describes an ostomy or stomal tract guide with deployable inner retaining flanges. [0062] FIG. 36 describes a ventilation catheter with two breath sensor arrays which use both negative and positive coefficient thermistors, useful in distinguishing between inspiration and exhalation in a variety of temperature conditions. [0063] FIG. 37 describes a screening and tolerance test algorithm and method for the purpose of evaluating a patient for the therapy of the subject invention. [0064] FIG. 38 describes a special catheter with a stepped or tapered dilation section. [0065] FIG. 39 describes the overall invention. REFERENCE NUMERALS [0066] [0000] Reference Numerals Q: Flow rate in LPM t: time in seconds y: y-axis x: x-axis I: Inspiratory phase E: Expiratory phase V: Volume Pt: Patient S: sensor signal P: lung or airway pressure T: Trachea L: Tracheal Lumen W: Tracheal Wall C: Carina LL: Left Lung RL: Right Lung AW: Anterior Tracheal Wall PW: Posterior Tracheal Wall PTCr: positive temperature coefficient reference thermistor PTC: positive temperature coefficient thermistor NTCr: negative temperature coefficient reference thermistor NTC: negative temperature coefficient thermistor R: resistor Prox: Proximal Dist: Distal LPM: liters per minute L: liters m/s: meters per second cwp: centimeters of water pressure cmH2O: centimeters of water pressure cl: centerline  1: HFJV flow curve  2: Patient breathing flow curve  10: High flow O2 therapy flow curve  14: Long term oxygen therapy (LTOT)continuous flow  15: Long term transtracheal oxygen therapy continuous flow curve  16: LTOT pulse demand oxygen delivery (DOD) flow curve  18: Mechanical Ventilator flow curve  20: Patient spontaneous breath effort flow curve  24: Continuous Positive Airway Pressure (CPAP) flow curve  21: Transtracheal inspiratory augmentation ventilation (TIJV) flow curve  25: Transtracheal inspiratory augmentation ventilation lung pressure curve  30: Primary Breath sensor  32: Dampened breath sensor  34: Signal difference between primary breath sensor and dampened breath sensor  36: Prior art pressure or flow sensor signal.  38: Drift in 36  40: Artifact in 36  42: First order differential of 34  43: Patient volume curve  44: LTOT volume curve  46: LTOT DOD volume curve  50: TIJV volume curve  52: Increase in TIJV amplitude  54: Adjustment of TIJV timing to earlier  56: Adjustment of TIJV timing to later  58: Secondary TIJV volume curve  60: Secondary ventilation gas flow 100: Ventilator 101: Battery 102: Counterflow delivery valve 103: Gas evacuation delivery valve 104: Medicant delivery unit 105: Biofeedback signal 110: Liquid Oxygen (LOX) unit 112: LOX reservoir 114: Vacuum chamber 116: LOX exit tube 120: Heater 122: Check valve 124: Heat Exchanger 126: Pressure regulator 127: 2 nd Pressure regulator 128: Oxygen gas reservoir 129: Toggle switch 130: Outlet On/Off valve 131: Pressure regulator manifold 132: Reservoir/accumulator inlet valve 140: O2 gas cylinder output regulator with >0.1″ diameter orifice 160: Oxygen concentrator unit 162: Pump 164: Pressure amplifier 166: Pressure regulator 168: Gas reservoir/accumulator 170: Gas supply 180: Cylinder 182: Piston 183: Valve ball 210: Insuflation gas flow 220: Venturi mixing valve 222: Ventilation Gas 224: Ambient Air 225: Venturi inlet port 226: Venturi check valve 230: Piston check valve 500: catheter 501: Breath sensor 502: catheter ventilation gas exit port 504: catheter insuflation gas exit port 506: gas exit nozzle 510: Nozzle restrictor element 512: Nozzle restrictor element in low Jet position 514: Nozzle restrictor element in high Jet position 520: Nozzle restrictor slide 522: Nozzle restrictor slide in low Jet position 524: Nozzle restrictor slide in high Jet position 530: Reservoir inlet check valve 540: Pressure amplifier inlet stage 542: Pressure amplifier inlet gas drive pressure 544: Pressure amplifier outlet stage 546: Pressure amplifier outlet pressure 548: Pressure amplifier gas supply 550: Pressure amplifier filter 552: Pressure amplifier gas supply regulator 554: Pressure amplifier gas drive inlet 556: Pressure amplifier gas supply inlet 558: Pressure amplifier gas supply outlet 570: Accumulator A1 572: Accumulator A2 574: Accumulator A1 outlet valve 576: Accumulator A2 outlet valve 590: Volume Control valve gas inlet 591: Volume Control valve variable orifice 592: Volume Control valve body 593: Volume Control Valve needle 594: Volume Control valve outlet 596: Volume Control valve outlet pressure sensor 598: Volume Control valve adjustment signal 600: Accumulator inlet check valves 602: Accumulator A 604: Accumulator B 606: Accumulator C 608: Valve A 610: Valve B 612: Valve C 614: Manifold 616: Orifice 1 618: Orifice 2 620: Orifice 3 640: Piston Outlet Chamber 650: Moving End Cap 652: Thread system 654: Adjustment Knob and screw 656: Adjustment drive belt 658: Rotational position sensor 660: End Cap position sensor 232: Piston Augmentation stroke spring 250: Augmentation Stroke 252: Refill Stroke 662: Pneumatic adjustment line 720: Exhalation counter-flow flow curve 722: Increased exhaled flow 724: Oscillatory counter-flow curve 726: sine wave counter-flow curve 728: Short pulse counter-flow curve 730: Ascending counter-flow curve 732: Multiple pulse counter-flow curve 734: Descending counter-flow curve 760: Non-uniform velocity profile 762: Non-diffuse gas exit 764: Uniform velocity profile 766: Diffuse gas exit 780: Gas evacuation flow curve 800: Concave accumulator/reservoir 802: Accumulator cylinder array 804: Ventilator enclosure 805: Hollow bilayer casing 806: Conduit Accumulator 808: Stomal Sleeve 809: Catheter 360 degree bend 810: Catheter 540 degree bend 811: Gas exit port 820: Guiding Cannula 830: Stiffening member 840: Anterior wall spacer 842: Catheter anterior curve 843: Catheter posterior curve 844: Adjustable Flange 850: Centering/anchoring basket 860: Short Trach Tube 864: Catheter 90 degree bend 870: Stomal seal 900: external catheter section 902: internal catheter section 904: non-Jet catheter 906: Jet catheter 908: Signature tag 910: Recognition tag 920: Sleeve external flange 922: Sleeve unfolded internal flange 924: Folded internal flange 930: Flange release cord 952: signal output 1 954: signal output 2 960: Wheatstone bridge circuit 962: Thermistors arrangement exposed to inhaled or exhaled flow 964: Thermistors arrangement exposed and less exposed to airflow 980: Exhalation Counterflow unit 982: Gas evacuation unit 984: Medicant delivery unit 986: Biofeedback signal 988: Auxiliary Flow DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0067] FIG. 1 and Tables 1 and 2 describe the ventilation therapy of the present invention in contrast to conventional therapies. In a main embodiment of the invention a ventilation method is described in which a patient's respiration is augmented by certain ventilation-oxygen delivery parameters, delivered directly into the trachea with an indwelling percutaneous transtracheal catheter coupled to a highly compact light weight portable ventilation apparatus worn or carried by the patient, subsequently referred to as Transtracheal inspiratory-synchronized jet-augmented ventilation (TIJV). Jet pulses of gas are delivered into the trachea in synchrony with the patient's inspiratory phase. [0068] FIGS. 1 f and 1 g describe TIJV and for comparison FIGS. 1 a - 1 e describe the conventional therapies. In FIG. 1 a , HFJV is shown, indicating the patient breathing flow curve 2 at around 20 breaths per minute. The Jet Ventilator flow curve 1 is asynchronous with the patient's breath cycle and cycling at a rate of around 60 cycles per minute. FIG. 1 b describes high flow oxygen therapy (HFOT). HFOT gas source flow is applied to the patient continuously as seen by the HFOT flow curve 10 . FIG. 1 c describes Transtracheal Oxygen Therapy (TTOT) and Pulse Demand Oxygen Delivery (DOD) therapy and the respective flow curves 14 and 16 . TTOT applies continuous flow 14 to the patient, typically 1-6 LPM and DOD delivers a low flow pulse oxygen flow 16 during inspiratory phase I. FIG. 1 d describes Transtracheal Open Ventilation (TOV) in which a mechanical breath 18 is delivered from a conventional intensive care ventilator when a patient breath effort 20 is detected. FIG. 1 e describes Continuous Positive Airway Pressure (CPAP) ventilation in which the lung pressure P of the patient is elevated to the CPAP pressure setting 24 . [0069] Now referring to FIGS. 1 f and 1 g , the TIJV flow curve 21 is shown to be in synchrony with the patient's inspiratory phase I and more pronounced than DOD. As can be seen by the change in lung pressure due to TIJV 25 , the therapy increases the lung pressure in the patient, thus helping the patient's respiratory muscles and showing that TIJV ventilation gas is penetrating deep in the lung. [0070] The gas is delivered at a frequency that matches the patient's breath frequency, typically 12-30 cycles per minute, thus at a relatively low frequency compared to HFJV which is typically 60 cycles per minute. A low minute volume of gas is delivered relative to CPAP, HFJV and HFOT, typically 25 ml-150 ml per breath, or typically 10-25% of the patient's tidal volume requirement. The gas source supply flow rate is relatively low compared to CPAP, HFJV and HFOT, typically 4-8 lpm, and the incoming pressure requirement for the ventilator is relatively low relative to CPAP, HFJV and HFOT, typically 10-30 psi. The gas can typically be delivered to the patient without adding artificial humidification as opposed to CPAP, HFJV and HFOT which requires heated humidification. [0071] The gas delivery velocity, typically 25-400 meters/second, is fast relative to LTOT and DOD which are typically around 10 meters/second. The jet effect allows for better penetration of oxygen into the lungs. The relatively fast gas exit velocity also causes a Venturi effect at the catheter gas exit point which entrains and pulls into the lung gas volume from above the catheter which is typically 5-100% of the volume delivered by the catheter. This entrained gas is naturally humidified and has a beneficial effect of adding to the mechanically delivered gas to extend the benefit of the therapy but without risking drying the lower airways and without risking inadvertent aspiration of saliva from the mouth or gastric contents from the esophagus into the airway due to the relatively low frequency compared to HFJV. In HFJV therapy, 50-75% gas volume (as a percentage of the delivered gas) is entrained from the upper airway but at 60 cycles per minute risking aspiration and compromising speech. HFJV is only useful in acute critical situations. [0072] The gas source supply in TIJV is typically either a liquid oxygen source (LOX), a compressed oxygen source, or an oxygen generation source. The system is an ultra compact portable system, lasting typically 2-8 hours depending on the size of the gas source, to maximize the mobility of the patient. With the unique TIJV parameters therefore, the pulsed gas delivery is designed to augment the patient's bulk ventilatory gas exchange, assist the respiratory muscles in breathing but without making them lazy, as well as to improve oxygen delivery, thus positively effecting both ventilation and diffusion. [0073] In DOD therapy, gas is always delivered in slow low volume pulses (<6 LPM) into the airway typically through the nasal route, thus effecting diffusion but not ventilation. Thus the invention herein is different from DOD therapy in that the gas pulses are delivered in a faster and higher volume pulse and at 12-30 LPM volumetric flow rate compared to 1-6 LPM volumetric flow rate in DOD, and therefore provides both ventilation and diffusion improvement, rather than just diffusion improvement as in DOD. [0074] It should be noted that conventional volume controlled or pressure controlled ICU-type ventilators have the ability to deliver assisted breaths upon sensing inspiration from the patient as described by Gregoretti in transtracheal open ventilation (TOV). However, in TOV, the ventilator delivers a full or substantially full mechanical breath to the patient and dominates the patient's breathing mechanics rather than truly assisting the patient. Although not yet described in the medical community, these ventilators could be set to deliver the same pressure or volume as in TIJV. However, these types of mechanical ventilators are designed for the patient to both receive mechanical breaths and exhale that breath volume back through the large bore breathing circuit attached to the ventilator. In TIJV, there is no exhalation by the patient out through the jet catheter to the ventilator, rather all the exhale gas exits the natural breath routes. If using a conventional ventilator which by design expects to detect exhaled gas exiting the breathing circuit, the ventilator would suspect a leak in the system since there would be no exhaled gas detected and a fault condition would be triggered and the ventilator function interrupted. Therefore, conventional ventilators can not be used to deliver TIJV therapy. In fact, there would be numerous alarms and ventilator inoperative conditions triggered if attempting to use a conventional ICU ventilator to deliver the therapeutic parameters through a small bore ventilation catheter. It is neither clear or obvious how these traditional ventilators could be modified to perform TIJV, and as such, a whole new ventilator design is required to perform TIJV. Further, due to their design, conventional ventilators are inherently heavy, non-compact and not suitable for ambulatory TIJV therapy. A key to TIJV is that its light weight and small size makes it conducive to ambulatory therapy. Ideally, a TIJV ventilator, including gas source and battery should be less than 5.5 lbs in order for it to be successfully embraced by users. [0075] Table 1 describes the output of TIJV ventilation compared to oxygen therapy devices, indicating the fundamental differences in outputs. [0000] TABLE 1 Output of Therapeutic Gas Source Systems O2 LOX Compressed Gas Concentrator Source Output TIJV Pulse Cont. Pulse Cont. Pulse Cont. Pressure Output 10-30 22 22 50 50 5 2 (dead ended, no flow, psi) Pressure Output, open to 4′ 3 mm  8-15 <5 <5 10  5 3 1 inner diameter catheter (psi) Flow Output, open to 4′ 3 mm inner 12-30 <6 <4 1-12 1-12 4 2 catheter (lpm) Table 2 describes in more detail the output of TIJV. [0076] [0000] TABLE 2 TIJV Therapy Description TIJV Transtracheal inspiratory-synchronized Jet- Parameter augmented ventilation Indications Ambulatory use for respiratory insufficiency Configuration Wear-able ventilator, fully equipped with oxygen supply and battery, with transtracheal ventilation catheter, used for open ventilation Description Patient's natural inspiration is mechanically augmented by a burst of oxygen rich gas Access Mini-trach (3-5 mm) or via existing tracheostomy tube (4-10 mm) or guiding cannula (4-10 mm) Volume delivered per cycle 25-250 (mililiters) 5-50% of tidal volume Peak pressure in catheter 70-200 (centimeters of water pressure) Lung pressure during raised but still negative delivery (centimeters of water pressure) Peak Flow (liters per minute) 12-50 LPM Insp. Time (sec) 0.1-0.8 Rate (breaths per minute) Patient's rate Timing Delivered at most comfortable point during patient's spontaneous breath, such as during peak inspiratory flow, or after muscles have reached maximum work, or early in inspiration Synchronization Patient decides breath pattern Breath Sensing Yes. Senses spontaneous airflow stream directly in airway Gas exit Velocity (meters per 25-250/5-100 second)/Entrainment (%) Humidification Not required [0077] In the main embodiment of the present invention, the breathing pattern is sensed for the purpose of timing and controlling the delivery of the TIJV augmentation volume delivery pulse. FIG. 2 describes an embodiment of using breath sensors which compensate for drift and artifacts. Various sections of the breathing curve are distinguished by analyzing the information from the breath sensors. For example, by taking the derivative of the breathing curve, different sections of the breathing curve can be discerned. For example, the change in sign would indicate the point in inspiration when the inspired flow stops increasing and starts decreasing. Or, different points between the start of inspiration and the end of inspiration could be discerned. These different characteristic points can then be used to trigger and time the delivery of the augmentation pulse. [0078] FIG. 2 a describes the patient breath flow curve 2 , and a primary breath sensor signal 30 which lags the patient breath flow curve, and a dampened breath sensor signal 32 which lags the primary sensor signal. In FIG. 2 b , the signal delta 34 between the primary and dampened sensor signals is plotted. The delta curve 34 therefore compensates for drift 38 or artifacts 34 that can be present in a typical breath sensing systems as shown in the prior art pressure or flow sensor signal 36 shown in FIG. 2 c which is derived from the typical pressure or flow sensors that are commonly used. FIG. 2 d shows the curve of the first order differential 42 of the signal delta curve 34 . [0079] In FIG. 3 conventional LTOT is described again, indicating the patient volume curve 43 and the LTOT volume curve 44 . FIG. 4 describes again DOD showing the patient volume curve 43 and the DOD volume curve. DOD systems deliver the oxygen to the patient when the breath sensor senses inspiration has started. Other than the response time in the system, typically 100-200 msec., the oxygen is delivered as soon as the start of inspiration has been detected. [0080] FIG. 4 describes how the present invention is different from the existing systems in that the augmentation Volume pulse 50 pulse is more pronounced and can be delivered at any strategic time within the inspiratory phase I. For example, the augmentation pulse can be delivered in the later half of inspiration after the respiratory muscles have produced their work or most of their work which occurs in the initial “increasing flow rate” section of the inspiratory curve. When persons are ventilated while the respiratory muscles are working, it is known that these persons can neuromuscularly become lazy and will, over time, let the ventilator do more and more of the inspiratory work, thus weakening the persons inspiratory muscles which is undesirable. The present invention can avoid this problem by delivering the oxygen later in the inspiratory phase when the inspiratory muscles are not working or doing less work. Or, alternatively, the augmentation pulse can be delivered early in inspiration. For example, if the patient is under exertion, inspiratory flow is steep at the beginning of inspiration and hence a very early augmentation trigger may be more comfortable, or if the patient is at rest, when the inspiratory flow curve is slow at the beginning of inspiration, a slight delay in the augmentation trigger time might be more comfortable. Further, in the present invention the start point of the augmented pulse delivery can be adjusted backwards and forwards in the inspiratory phase as desired, by manual adjustment or by automatic adjustment for example by a feedback from a respiratory parameter. The delivery time is typically 0.1 to 0.8 seconds, depending on the length of the person's inspiratory phase and I:E ratio. Further, in the main embodiment of the present invention, breath sensors are included on the catheter to directly measure inspiratory and expiratory air flow within the trachea, as opposed to all other prior art systems which if measuring the breathing curve measure air flow or air pressure in the catheter or breathing circuit lumen. Both flow directionality and flow amplitude are measured to discern both the phase of respiration and the depth of respiration throughout the entire breathing pattern. Prior art systems are only good at measuring the start of inspiration and no other portions of the breathing curve. [0081] Also, in the present invention, multiple pulses can be delivered within inspiration, the pulse amplitude can be adjusted 52 , the pulse can be moved earlier in inspiration 54 or moved later in inspiration 56 . In addition a secondary lower volume augmentation pulse 58 can be delivered adjunctively to the augmentation volume pulse 50 , or a secondary ventilation gas flow 60 can be delivered adjunctively to the augmentation volume pulse 50 . [0082] Further in the main embodiment of the present invention, FIGS. 5-19 describe unique pneumatic drive systems to provide the pressure and flow required for TIJV. [0083] First, in FIG. 5 a unique LOX system is described to provide the pressure and flow required for TIJV, including a ventilator 100 , LOX unit 110 , LOX 112 , LOX unit vacuum chamber 114 , LOX outlet tube 116 , heat exchanger 124 , heater 120 , check valve 122 , oxygen gas reservoir 128 , reservoir pressure regulator 126 , gas outlet on/off valve 130 , outlet to patient Pt and incoming breath signal S. Typical LOX systems include a liquid phase oxygen compartment and an oxygen gas phase compartment which is continually filled by the boiling of the liquid oxygen. The phase change is catalyzed by a heat exchanger unit. These systems maintain the gas phase compartment at about 23 psi by bleeding gas to atmosphere to avoid pressurization beyond 23 psi. Typical medical LOX systems have been designed specifically to conserve oxygen and as such their output is relatively weak compared to the requirements of TIJV. The compact LOX systems which are designed for portability are engineered to deliver gas at very low flow rates (<3 LPM) and low pressures (below 5 psi). The larger less portable LOX units are engineered for greater flow output however are not realistically suited for active ambulatory patients because of their larger size. The typical systems are capable of delivering oxygen gas at a continuous flow rate of below 4 liters per minute at a pressure well below 23 psi since the pressure in the gas phase compartment drops within fractions of a second when the system is opened to the patient. The gas phase compartment contains typically less than 50 ml of gas and the rate of gas creation by boiling is limited to below 4 liters per minute due to the design and construction of the heat exchanger which is typically less than 20 square inches surface area. Gas flow output to the patient is also limited by the size of the orifice in the outlet valve, typically less than 0.10″ diameter, thus restricting airflow. In the present invention the heat exchanger unit 54 is designed with greater surface area, typically greater than 30 square inches, to produce gas at the rate of 6-10 liters per minute and the outlet orifice allows that flow rate output as well, typically greater than 0.15″ diameter. A heater 56 may be added to increase the rate of production of gaseous 02 . The gas volume of the gas phase compartment is typically above 80 ml and can be 250 ml, which typically includes a pressure regulator 60 , a reservoir 58 , check valve 66 , on/off valve 62 and incoming breath signal 64 . This unique design provides an oxygen gas output flowrate of above 6 LPM at above 20 psi continuously, thus meet the demands of the ventilation parameters required in TIJV. The unique LOX system includes a catheter and all the requisite sensing components and timing functions described earlier in order to deliver the required volume of gas at the correct pressure and at the correct time of the breathing curve. [0084] In FIG. 6 an additional embodiment is shown comprising a, LOX system with two pressure settings. One low pressure regulator 126 with a setting of 23 psi to be used when the patient requires less powerful therapy or needs to conserve the LOX, and a higher pressure regulator 127 with a setting of for example 30-50 psi for increasing the output of the unit when needed or when conserving the LOX is not a concern. For example, when traveling on an airplane, the LOX system can be-set at the low 23 psi setting, and reset to the high setting after the flight or when arriving to the destination where there is a refill station. The two pressure regulators are configured in a manifold 131 which can be operated by a switch 129 to switch between settings. During flight, the patient can still receive the TIJV therapy but at a lower level of augmentation corresponding the to 23 psi setting, but after the flight and when the patient becomes more active again, the augmentation level can be increased because the pressure is set to the higher output setting. Two pressure settings are exemplary and it can be any number of pressure settings or even a continuous adjustment of the pressure setting between a minimum and maximum value. [0085] FIG. 7 describes an alternate embodiment in which a compressed oxygen gas source is combined with the TIJV ventilator features to create an integrated ventilator and gas source unit. The output regulator of the oxygen cylinder has a larger orifice than in a traditional oxygen therapy gas flow regulator, typically 0.1-0.2 inches in diameter, such that the flow output can be boosted to >6 LPM and meet the demands of TIJV. [0086] In FIG. 8 an alternate embodiment to the present invention is shown comprising a unique oxygen generating device which can be used to provide the requisite ventilation parameters. An oxygen generator unit 160 is integrated into a ventilator 100 which includes a pump 162 , a pressure amplifier 164 , a gas reservoir/accumulator 168 , a reservoir inlet regulator 166 , and a reservoir outlet on/off valve 130 . Typical oxygen generating devices produce a relatively weak output of oxygen (<2 LPM at <5 psi). By increasing the storage capacity and optionally including a pneumatic pressure amplifier, the output can be boosted to 4-10 LPM and 10-30 psi., thus powerful enough to meet the pressure and volume needs of TIJV. This unique oxygen generator system includes a catheter and all the requisite sensing components and timing functions described earlier in order to deliver the required volume of gas at the correct pressure and at the correct time of the breathing curve as required with TIJV therapy. [0087] FIG. 9 : In another main embodiment of the present invention, TIJV therapy can be accomplished by using a conventional gas source 170 , such as a LOX systems, compressed gas tanks, or oxygen generator systems, but with a unique volume accumulator 168 and inlet valve 132 placed in between the gas source and the patient. The accumulator acts as a capacitor and stores a pressurized volume of gas close to the patient. The outlet of the accumulator is relatively unrestricted so that a relatively high flow rate can be delivered to the patient during the augmentation time and therefore meeting the requisite volume and pressure requirements. During the augmentation delivery period, the accumulator is depressurized to the patient through a valve which is switched open and during the non-augmentation time the accumulator is re-pressurized from the gas source by closing the patient valve and opening a valve between the accumulator and the gas source. Because the augmentation:non-augmentation time ratio is typically 1:2-1:3, the accumulator is able to be sufficiently re-pressurized in between augmentation pulses. Without the accumulator, the conventional gas supply systems do not have enough flow rate output and/or pressure output to meet the ventilation parameters of TIJV. A further benefit to this embodiment is safety; because of the valve configurations, if a valve where to fail open, only the cylinder volume could be delivered to the patient. This unique accumulator system is accompanied by all the requisite sensing components and timing functions described earlier in order to deliver the required volume of gas at the correct pressure and at the correct time of the breathing curve. [0088] FIG. 10 : In another main embodiment of the present invention, TIJV therapy can be accomplished by using conventional gas sources (LOX systems, compressed gas or O2 concentrators), but with a unique cylinder and piston placed in between the gas source and the patient. Flow from the gas source 170 flows through an inlet valve 132 into a cylinder 180 , moving a piston 182 while an outlet valve 130 is open to the patient Pt and closed to the gas source 170 . A valve ball 183 or similar valve feature prevents the gas source from being directly connected to the patient. The cylinder stores a pressurized volume of gas similar to the accumulator system described previously in order to boost the flow rate to the patient to meet the TIJV requirements. In addition however the piston in the cylinder compresses the volume in the cylinder as the gas is being delivered to the patient, therefore reducing the pressure and flow rate decay occurring in the cylinder (due to the compression) and therefore boosting the volume delivered to the patient in a given period of time and maintaining peak pressure of the delivered gas for a longer period of time. A further benefit to this embodiment is safety; because of the valve configurations, if a valve where to fail open, only the cylinder volume could be delivered to the patient. This unique accumulator/piston system is accompanied by all the requisite sensing components and timing functions described earlier in order to deliver the required volume of gas at the correct pressure and at the correct time of the breathing curve. Comparison of FIG. 10 b which represents a cylinder 180 with no piston and FIG. 10 c which represents a cylinder 180 with a piston 182 , shows the increase in mean pressure output and volume caused by using the piston. [0089] FIG. 12 describes in more detail the jet effect of the invention. A unique catheter 500 is described to deliver the gas to the patient in the appropriate manner. The delivery catheter may include a nozzle 506 or diameter restriction at its distal tip (the patient end) located above the carina C in the lumen L of the trachea T. The nozzle is dimensioned so that the exit velocity of the gas is increased creating a venturi effect in the local area around the catheter tip. The venturi entrains air from the upper airway above the catheter and pulls that entrained air 400 into the left lung LL and right lung RL with the augmentation jet flow 21 . Thus, the total amount of therapeutic gas provided to the patient is the TIJV augmented volume (VA) 50 being delivered from the ventilator, plus the entrained volume (VE) 400 , thus adding to the ventilatory support provided by the VA alone. Since the VE is pulled from the upper airway, it is naturally humidified and in this manner, TIJV can be successful for longer periods of time without adding artificial humidification. Further, the exit velocity can be designed such that there is for example 50% entrainment, so that only half of the therapeutic volume comes from the ventilator, thus doubling the length of use of the portable oxygen supply being used. The jet can be tailored to provide 5%-100% entrainment, and if desired can even cause >100% entrainment. For comparison, the effects of TIJV are compared to DOD indicating TIJV increases entrained volume and reduces patient respiratory rate because the patient's breathing becomes less strenuous, whereas DOD does not effect these parameters. [0090] Alternatively, as shown in FIG. 13 the nozzle dimensions at the tip of the catheter can be automatically and/or remotely adjustable, for example by moving an inner element or by inflating or deflating a element near the tip ID. For example a nozzle restrictor element 510 can be deflated 512 to produce a low jet output and can be inflated 514 to produce a high jet output. Or a nozzle restrictor slide 520 can be moved from less restricted nozzle position 522 to a more restricted position 524 to increase the jet effect. In this embodiment the nozzle would be adjusted to alter the percentage of entrained airflow, for example if the patient sensed dryness in the nasal cavity or sensed saliva being aspirated into the trachea, the amount of jet velocity could be reduced without removing the catheter in order to reduce the amount of entrained gas from above the catheter. Or if the patient needed more mechanical support then the jet could be increased. The jet adjustment could optionally be done automatically by use of physiological feedback signals. [0091] FIG. 14 : In a further embodiment of the present invention, ambient air can be mixed in with the oxygen gas being delivered with a low or no electrical power consuming mixing device. For example, ambient air can be mixed in with the pressurized oxygen by sucking the air in by creating a venturi effect with the pressurized flowing oxygen gas, or air can be added by the appropriate valving, or can be added by check valves in a mixing chamber, or can be added to mixing chamber with a small, low-power consumption pump. For example in FIG. 14 a , a Venturi air mixing unit 220 is shown receiving oxygen rich gas 222 from a gas source, a venturi port 225 with check valve 226 for sucking in ambient air 224 . Also for example in FIG. 14 b a piston system is shown comprising a piston 182 with check valves 230 such that when the piston strokes 250 to deliver volume to the patient the check valves are closed, and when the piston performs a refill stroke, air enters the chamber through the check valves. Air 224 is brought into the cylinder 180 through an inlet valve 132 and oxygen rich ventilation gas 222 is brought into the cylinder through the outlet valve 130 . Oxygen rich ventilation gas mixed with air is then released to the patient through the outlet valve. The addition of air into the oxygen gas extends the duration of use of the compact portable system. For example a system using a 1 liter cylinder of compressed oxygen can last 2 hours if the ventilator is delivering augmentation pulses of 100% oxygen, however if ambient air is mixed in so that the augmentation pulses are 50% oxygen and 50% nitrogen, then the 1 liter cylinder can last approximately 5 hours. [0092] FIG. 15 : In another embodiment of the present invention a pressure amplification device is used to boost the pressure output of the system to the patient. The ventilator 100 includes a gas source 170 , a pressure amplifier unit 530 , a reservoir/accumulator 168 , on on/off valve 130 , flow to the patient Pt and an incoming breath signal S. The pressure amplifier unit includes an inlet stage 540 receiving a drive air pressure 542 and an outlet stage 544 emitting a amplified air pressure 546 . Schematically the amplifier includes a gas supply 548 , a filter 550 , a regulator 552 , a gas drive inlet 554 , and a gas supply outlet 558 . Incoming pressures from the gas supply can be as low as 1 psi and amplified to 10-30 psi., thus providing adequate pressure and flow to accomplish TIJV. Alternately, the output of the pressure amplifier can be stored in an accumulator which will boost the volume that can be delivered during depressurization of the accumulator during an augmentation pulse as described previously. The pressure amplifier will allow a relatively weak gas supply such as a small LOX system, an oxygen concentrator system, or a low powered electrical air pump to be used for the gas source. The pressure amplifier unit can be pneumatically powered or electro-pneumatically powered. [0093] FIG. 16 : In another embodiment of the present invention, multiple accumulators or pistons are used to store and deliver the augmentation volume. The ventilator 100 includes a gas source 170 , an array of accumulators 570 and 572 , with outlet valves 574 and 576 and a main outlet valve 130 to the patient Pt. The accumulators or pistons can alternate such that for example a first accumulator or piston depressurizes to the patient for a first augmentation pulse and a second accumulator or piston depressurizes to the patient in the next augmentation pulse. In this manner, each accumulator or piston has a longer re-pressurization time (twice as long compared to a system with one accumulator or piston), therefore able to deliver sufficient volume during the augmentation pulse because of starting to depressurize from a higher pressure. This embodiment is particularly useful in fast breath rate situations for example greater than 30 breaths per minute. [0094] FIG. 17 : In another embodiment of the present invention, a unique system is described to provide independent control of augmentation volume and augmentation time for delivering TIJV, but without using a pressure or volume feedback loop. FIG. 17 a describes the conventional approach of a flow control valve with a needle, 593 , a variable orifice 592 , a valve body 591 , a valve inlet 590 and outlet 594 , a pressure or flow sensor 596 and a feedback adjustment signal 598 . In the invention shown in FIG. 17 b , an array of accumulators 602 , 604 and 606 with check valves 600 and an array of orifices 616 , 618 , and 620 of different sizes are arranged with a valving system 608 , 610 , and 612 and manifold 614 such that any reasonably desired augmentation time and augmentation volume can be delivered by activating the correct combination of accumulator(s) and using the correct orifice size. This embodiment allows for independent selection of augmentation volume delivery time and augmentation volume. For example, 100 ml can be delivered in 0.2 seconds or can be delivered in 0.4 seconds, depending on what is desired. [0095] FIG. 18 : In another embodiment of the present invention a piston with a spring is used to amplify volume delivered to the patient. The reservoir/accumulator 168 includes a cylinder 180 , a moving piston 182 , an outlet valve 130 to the patient PT, a pressurization and depressurization outlet chamber 640 , and a spring 232 . The piston strokes in one direction by the cylinder depressurizing through a valve 130 to the patient. A compressed spring 232 on the opposite side of the piston adds speed to the moving piston, thus increasing the cylinder outlet flow rate to the patient. The cylinder then re-pressurizes through the valve 130 and compresses the spring 232 and repeats the cycle for the next augmentation delivery. [0096] FIG. 19 : In another embodiment of the present invention, an adjustable volume cylinder is used to modify volume delivery. In this embodiment shown, the piston in the cylinder stokes from side to side and each stroke sends volume to the patient while to opposite side of the chamber on the other side of the piston is re-pressurizing from the gas supply in preparation for the next stroke to the patient. The cylinder 180 includes a moveable piston 182 , inlet and outlet valves on both ends of the cylinder 130 and 132 , a moveable end cap 650 , a thread system 652 used to move the end cap, an adjustment knob and screw 654 , optionally an adjustment drive belt 656 or other drive system, optionally a knob and screw rotational position sensor 658 , and optionally an end cap axial position sensor 660 . The adjustment can be manual, for example by use of the knob and screw to move one end cap of the cylinder inward or outward. The changed volume will affect the volume delivered during the cylinder depressurization because of the changed capacitance of the accumulator. Alternatively, the adjustment can be electronically controlled and optionally the adjustment position can be sensed for display or control loop function by use of sensors, 660 or 658 . Also, alternatively the same adjustment mechanisms can be applied to the piston embodiments described previously. [0097] FIG. 20 : In another embodiment of the present invention, the augmentation pulse can be shaped in a desired waveform. This is accomplished for example by control of the piston stroke speed which can be controlled with a variable orifice on the outlet of the cylinder, or gas source pressure or stoke speed. For example as shown in the graphs the TIJV volume 50 can be a sine wave, square wave, descending wave or ascending wave. [0098] FIG. 21 : In another embodiment of the present invention exhalation counter-flow is described which will have the effect of reducing collapse of the diseased, collapsible distal airways by giving those airways a back pressure. An increase in exhaled flow 722 and more volume is then able to be exhaled by the patient during exhalation. The exhalation counter-flow can be delivered in a variety of pressure or flow profiles, such as a square exhalation counter-flow flow curve 720 , a short pulse 728 , multiple pulses 732 , ascending or descending profiles 730 and 734 , oscillation 724 , sign wave 726 , or at the beginning or end of exhalation and at high, medium or low amplitudes. The exhalation counter-flow can be delivered by the piston described previously while the piston is stroking in the opposite direction of an augmentation stroke, or it can be delivered by a simple valve between the patient and the gas supply, or by a second cylinder or piston independent of the augmentation delivery mechanism. A catheter 500 is shown in the lumen L of the trachea T. The exhalation counterflow gas exit from the catheter can be non-diffuse 762 to cause a non-uniform velocity profile 760 , or can be diffuse 766 to create a more uniform velocity profile 764 . The gas exit dynamics are adjusted by the gas exit ports on the catheter, a signal port is useful for non-diffuse gas exit and several small side ports are useful for diffuse gas exit. The velocity profile is selected based on the collapsibility of the patients' airways; for example a more uniform profile is used for higher degrees of collapsibility. The counterflow amplitude can also be adjusted manually or automatically based on a physiological signal such as CO2, exhaled flow, volume change. [0099] FIG. 11 : In another embodiment of the present invention tracheal gas insufflation flow 210 can be delivered to create a higher oxygen gas concentration in the upper airway, adjunctively to the TIJV augmentation flow 21 . The catheter 50 includes an augmentation flow exit port 502 and an insufflation flow exit port 504 . The insufflation can be delivered at a strategic time during the patient's inspiratory phase or can be delivered at a strategic time during the patient's expiratory phase. For example, if insufflation is delivered during the 250 msec of inspiration that precedes the augmentation pulse, then the entrained air sucked into the lung by the augmentation jet will be higher in O2 content. Or, if insufflation is delivered during exhalation it can have the effect desired plus also provide exhalation counterflow described previously. The amplitude of the insufflation flow can be adjustable, manually or automatically. [0100] FIG. 22 : In another embodiment of the present invention tracheal gas evacuation is used to lower the CO2 content in the trachea, which will cause a lower CO2 content in the distal compartments of the lung due to mixing and diffusion that will occur because of the concentration gradient. The evacuation flow 780 can be applied during inspiration, exhalation or both and the evacuation profile can be constant, oscillatory, synchronized, sinusoidal, etc., or can be applied intermittently at a rate and amplitude as determined by biofeedback such as by monitoring CO2 levels in the trachea. [0101] FIG. 23 : In another embodiment of the present invention, the ventilator can include a non-cylindrical gas accumulators or gas supply reservoir in order to optimize the overall shape of the compact ventilator, since an optimally small ventilator may not accommodate the conventional shape of a gas cylinder. For example the shape can be concave 800 , or an interconnected series of cylinders 802 , or a conduit system 806 . Or the ventilator enclosure 804 itself can comprise the gas reservoir or gas supply by having a bilayer casing 805 . In the case shown the ventilator enclosure cross section is bone-shaped, however it could be of any reasonable shape. Unorthodox shaped reservoirs are capable of handling the typical working pressure of the invention which is below 50 psi. [0102] In another embodiment of the present invention, the ventilator is electrically powered by a manual hand-cranked charging generator unit, either internal to the ventilator or externally connected to the ventilator, (not shown). [0103] In another embodiment of the present invention the ventilator can receive gas flow and pressure by a manual pneumatic pump system actuated by the user, (not shown). [0104] In other embodiments of the present invention shown in FIGS. 24-33 , catheter designs are described which will space the catheter tip in the center of the trachea, so that the tip is not poking, irritating or traumatizing the wall of the trachea, a problem described with other transtracheal catheters. Also, stabilizing the catheter tip in the center of the tracheal lumen so that the tip does not whip during the jet pulse is important. Whipping, a problem with other catheters, can cause tracheal wall trauma. Further, the tip should be directed generally in the direction of the carina C and not towards a tracheal wall W, in order for the augmentation pulse to effectively reach the lower portions of the left lung LL and right lung RL. [0105] FIG. 24 : In one embodiment of the invention, a looped catheter with approximately a 360 degree curve 809 , is described which is inserted through a stomal sleeve 808 and contacts the anterior wall AW, spaces it from the posterior wall PW, and spaces the catheter gas exit port 811 in the center of the tracheal lumen L. The catheter lumen beyond the exit port is occluded so the gas can exit out of a the port 811 , or the loop can extend so that the catheter tip points downward toward the carina. The catheter loop is biased so that the anterior section of the loop is always touching the anterior tracheal wall thus assuring that the catheter exit port will be somewhere in the middle of the tracheal lumen. Alternatively as shown in FIG. 25 , the catheter can comprise approximately a 450-540 degree loop 810 so that the distal tip is directed down toward the carina. In this embodiment it may be more advantageous for the catheter bend to be biased such that there is contract with either or both of the anterior and posterior tracheal wall. This embodiment will also apply a gentle tension on the tracheal wall to help keep it in position, however when the trachea collapses with coughing, the curved catheter will compress with the trachea. [0106] FIG. 26 : In another embodiment of the invention a dual cannula design is described with an ostomy or stomal sleeve 808 . The outer guiding cannula 820 removably attaches to the sleeve so that the guiding cannula can be removed and reinserted conveniently. The guiding cannula is especially thin wall, for example 0.010″-0.030″ and is typically made of a braid or coil reinforced elastomer or thermoplastic to resist kinking. The guiding cannula, although semi-rigid, is short compared to the front-to-back width of the trachea and therefore is atraumatic. The inner cannula is the TIJV catheter and is dimensioned to fit the ID of the guiding cannula snuggly. The tip of the TIJV catheter extends beyond the tip of the guiding cannula. The guiding cannula semi-rigidity provides a predetermined known track for the TIJV catheter to follow and therefore positions the TIJV catheter tip somewhere in the tracheal lumen and not touching the tracheal wall. [0107] FIG. 27 : In another embodiment of the invention a shaped catheter design is described which is intended to remain close to the anterior wall of the trachea, thus when the patient's trachea collapses during coughing or bronchospasm, the posterior wall is not irritated. Near the tip of the catheter the catheter makes a gentle anterior bend 842 and posterior bend 843 such that the tip is directed away from the tracheal anterior wall. The stomal sleeve inner flange 922 provides a spacing of the catheter away from the anterior wall in that location. The catheter includes an flange 844 that can be adjustable. Alternatively the catheter tip can include an atraumatic spacer that pushes it away from the anterior tracheal wall. [0108] FIG. 28 : In another embodiment of the invention a catheter design is described which is comprised of extremely soft material, for example 30-60 shore A so that it does not irritate the tracheal wall when it comes in contact with it. The shape of the soft highly flexible catheter is maintained by a rigid filament stiffening member 830 imbedded into the catheter construction, for example a thin stainless steel, thermoplastic or shape memory wire shaped-set into the required and desired shape. [0109] FIG. 29 : In another embodiment a catheter is described which is connected to the male connector of a standard tracheal tube such as a short tracheostomy tube 860 or a laryngectomy tube and which includes a protruding or extending sensor 900 which extends through the length of the tracheal tube and into the tracheal airway where the sensor can sense airflow. [0110] FIG. 30 : In another embodiment of the invention a catheter design is described that has an anchoring basket 850 to center the catheter in the tracheal lumen. The basket is highly forgiving such that partial or full collapse of the tracheal diameter (during coughing or spasms) is not impeded by the basket and any contract is atraumatic. The basket material must be lubricious and rounded so that it does not encourage granulation tissue growth and become attached to the tracheal wall. The basket is typically releasable from a sleeve for easy insertion and removal but can also be easily inserted and removed through the ostomy due to its compliant nature. Alternatively, the basket can be an inflatable fenestrated cuff. [0111] FIG. 31 : In another embodiment of the invention a catheter design is described which includes a spacer 840 that spaces it from the anterior wall of the trachea. The spacer can be a soft material or a shape memory foam encapsulated in a highly compliant membrane. Or, the spacer can be an inflatable cuff. The cuff can be a normally deflated cuff that requires inflation by the user, or can be a normally inflated and self inflating cuff which requires deflation for insertion and removal. The spacer can be a protrusion of the stomal sleeve 808 or the catheter 50 . [0112] FIG. 32 : In another embodiment of the invention a shaped catheter design is described which is intended to distend in the tracheal lumen minimally, by being shaped in a right angle or approximately a right angle 864 . This shape allows the tip of the catheter to be directed downward toward the carina, but with a very short catheter length. This shape may be advantageous when the trachea is moving and elongating since the body of the catheter will not be contacting the tracheal walls, unless the trachea is collapsed. The catheter also includes an adjustable flange 860 to set the required depth of insertion of the catheter. [0113] FIG. 33 : In another embodiment a catheter is described comprising a compliant and/or inflatable sealing sleeve 870 for sealing and securing the catheter shaft transcutaneously to the ostomy site. The sleeve can be a self deflating or inflating or a manually deflating or inflating design, for example a memory foam encapsulated by a compliant elastomeric membrane with a deflation bleed port. [0114] FIG. 34 : In another embodiment a smart catheter is described in which there is a proximal external catheter section 900 and distal internal catheter section 902 which connect to each other. Each section contains a miniature device that produces an electrical signature wherein the distal section signature tag 908 is recognized by the proximal section recognition tag 910 . In this manner, different catheter designs for different therapeutic modes can be attached to the ventilator unit, and the ventilator unit will detect which catheter and therefore which mode should be used. For example, a non-jet catheter 904 can be attached and the ventilator can switch to non-jet mode, and a jet catheter 906 can be attached and the ventilator switches to a jet mode. Or the electrical signature can track usage time and alert the user when the catheter needs to be replaced or cleaned. Or the signature can be patient specific or distinguish between adults and pediatric patients, or to report on therapy compliance. [0115] FIG. 35 : In another embodiment a transtracheal catheter sleeve 808 is described for placement in the trachea transcutaneous ostomy site. The sleeve comprises a proximal flange 920 and a distal flange 922 for the purpose of positioning the distal end of the sleeve just barely inside the tracheal lumen and preventing inadvertent decannulation of the sleeve. The distal flange is retractable into the main lumen of the sleeve so that when the sleeve is being inserted into the ostomy the retracted flange 924 is not protruding and the sleeve can assume a low profile for easy and atraumatic insertion. Then, when inserted into the trachea, the flange can be deployed by pushing a trocar against the retracted flange or by releasing a release cord 930 which was keeping the flange in the retracted state. [0116] FIG. 36 : A sensor arrangement is described which combines negative thermal coefficient NTC and positive thermal coefficient PTC thermistors to detect cooling and heating for the purpose of determining breath flow directionality. The NTC thermistor is especially effective in detecting inspiration; as the thermistor is cooled by the cooler inspired air, the start of inspiration is detected. The PTC thermistor is especially effective in detecting exhalation; as the thermistor is heated by the warmer exhaled air the start of exhalation is detected. An external reference thermistor is used to measure ambient temperature. If the ambient temperature is cooler than body temperature which will normally be the case, the arrangement described is used, however if ambient temperature is warmer than body temperature, then the operation of the NTC and PTC thermistors is reversed. Each thermistor is paired with a reference thermistor NTCr and PTCr and the signals from each pair of sensing thermistor and its reference thermistor are processed through an electronic comparator, such as a wheatstone bridge 960 with resistors R to complete the bridge, to yield a dampened output signal 952 and 954 that dampens artifacts in the respiratory pattern and drifts that occur because of surrounding conditions. Alternatively, the thermistor sensors can be heated by applying a voltage to them such that their resting temperature and resistance is kept at a known constant value. Therefore, heating and cooling from inspiration and exhalation is highly predicable when ambient temperature is known. For example, the thermistors can be warmed to a temperature of 120 degrees F. Exhalation cools the thermistor less than inspiration and therefore the breath phase can be determined. The thermistors can be arranged on the catheter such that the positive coefficient thermistors are located on the side of the catheter facing exhaled flow, and the negative coefficient thermistors are located on the side of the catheter facing inspired flow, 962 . Or alternatively, the thermistors can be spacially arranged in some other strategic orientation such as placing the sensing thermistors such that they are fully exposed to airflow and the reference thermistors such that they less exposed to airflow 964 . [0117] In another aspect of the present invention, sensors are included to provide biofeedback for a variety of purposes. For example, the presence of coughing or wheezing or dyspnea is monitored by comparing the measured breathing curve to algorithms in the software. If an exacerbation is detected, a medicant can be delivered, such as a bronchodilator. Or, tracheal humidity can be monitored for the purpose of increasing or decreasing the delivered volume so that the lung does not become dry, or alternatively the jet venturi can be increased or decreased to increase or decrease upper airway entrainment, in order to maintain the correct lung humidity or correct ventilation volume. Or, patient activity level can be monitored with an actigraphy sensor and the ventilation parameters can be adjusted accordingly to match the activity level of the patient. Or the patient's venous oxygen saturation can be measured in the percutaneous ostomy by a pulse oxymetry sensor placed in the ostomy sleeve or in the catheter and the ventilation parameters adjusted accordingly. Or the patient's tracheal CO2 level can be measured with a CO2 sensor and the ventilation parameters adjusted accordingly. All these prospective measured parameters can be transmitted by telemetry or by internet to a clinician for external remote monitoring of the patient's status. [0118] FIG. 37 : Another potential problem of new minimally invasive ventilation and oxygen therapy modalities is the patient acceptance and tolerance to the new therapy, and the acclimation of the body to the intervention such as a minitracheotomy. For example patients may not want to have an intervention performed unless they can experience what the effect of the therapy will be. Or for example, the body may be initially irritated by the intervention, and if the therapy is started immediately after the intervention, the benefit may be spoiled by other physiological reactions. Therefore in another aspect of the present invention a novel medical procedural sequence is described, to allow the patient to experience the therapy and to acclimate the patient to the intervention before the therapy is started. The patient is subjected to a tolerance test by using a non-invasive patient interface such as a mask or nasal gastric tube or a laryngeal mask or oropharyngeal airway (NGT, LMA or OPA). In the case of using the NGT the patient's nasal cavity can be anesthetized to allow the patient to tolerate the NGT easily. TIJV is then applied to the patient in this manner for an acute period of time to determine how well the patient tolerates the therapy. Also, information can be extracted from the tolerance test to extrapolate what the therapeutic ventilation parameters should be for that patient. After the tolerance test, a mini-otomy procedure is performed and an acclimation sleeve and/or acclimation catheter is introduced into the airway. After a subchronic acclimation period with the temporary sleeve/catheter, for example one week, the therapeutic catheter and/or ostomy sleeve is inserted into the patient and the therapy is commenced, or alternatively another brief acclimation period will take place before commencing the ventilation therapy. If the patient was a previous tracheotomy patient, for example having been weaned from mechanical ventilation, then the tolerance test can be applied directly to the trachea through the tracheotomy. If the patient was a previous TTOT patient, for example with a 3 mm transtracheal catheter, in the event the mature ostomy tract is too small for the TIJV catheter, then the tolerance test can be administered from the nasal mask, NGT, LMA or OPA as described previously, or alternatively the tolerance test is performed using a smaller than normal TIJV catheter that can fit in the existing ostomy. Or alternatively the tolerance test is delivered directly through the ostomy pre-existing from the transtracheal catheter using the same or similar transtracheal catheter, or a transtracheal catheter with the required sensors. Then if needed, a larger acclimation catheter and or sleeve is placed in the ostomy to dilate it and after the correct acclimation period the therapy is commenced. [0119] FIG. 38 : In another embodiment of the present invention a special catheter is described with a stepped or tapered dilatation section. The catheter can be used to dilate the otomy to the appropriate amount during an acclimation period or during the therapeutic period by inserting to the appropriate depth, or can be used to successively dilate the otomy to larger and larger diameters. The catheter tapered section can be fixed or inflatable. Length and diameter markings are provided so that the proper diameter is used. [0120] FIG. 39 describes the overall invention, showing a wear-able ventilator 100 being worn by a patient Pt, which includes an integral gas supply 170 , battery 101 , volume reservoir/accumulator 168 , on/off outlet valve 130 , transtracheal catheter 500 , a tracheal airflow breath sensor 101 and signal S, as well as an optional exhalation counterflow unit 980 , gas evacuation unit 982 and medicant delivery unit 984 and respective flow output or input 988 , and a biofeedback signal 986 . [0121] It should be noted that the different embodiments described above can be combined in a variety of ways to deliver a unique therapy to a patient and while the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and combinations can be made without departing for the present invention. Also, while the invention has been described as a means for mobile respiratory support for a patient, it can be appreciated that still within the scope of this invention, the embodiments can be appropriately scaled such that the therapy can provide higher levels of support for more seriously impaired and perhaps non-ambulatory patients or can provide complete or almost complete ventilatory support for non-breathing or critically compromised patients, or can provide support in an emergency, field or transport situation. Also, while the invention has been described as being administered via a transtracheal catheter it should be noted that the ventilation parameters can be administered with a variety of other airway interface devices such as ET tubes, Tracheostomy tubes, laryngectomy tubes, cricothyrotomy tubes, endobronchial catheters, laryngeal mask airways, oropharyngeal airways, nasal masks, nasal cannula, nasal-gastric tubes, full face masks, etc. And while the ventilation parameters disclosed in the embodiments have been specified to be compatible with adult respiratory augmentation, it should be noted that with the proper scaling the therapy can be applied to pediatric and neonatal patients.

1a

CROSS REFERENCE TO RELATED APPLICATION The present invention is a continuation-in-part of the copending U.S. Patent Application Ser. No. 824,860 of the same title filed Jan. 31, 1986, now U.S. Pat. No. 4,663,880, and the disclosure and prosecution thereof is incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to fishing lures. More particularly, it relates to self-contained light emitting fishing lures for enhanced fish attracting qualities. 2. Description of the Prior Art Six prior art patents have been located which disclose light emitting fishing lures. The first is U.S. Pat. No. 4,227,331 issued Oct. 14, 1980 to Ursrey, et al. for a Fish Lure. That patent describes a lure which uses one or more light emitting diodes, preferably of a type which emits green light, and includes a suitable power source disposed interally of the lure body for energizing the diode. The light emitting diodes are attached to and protrude outwardly from the lure body so as to provide wide angle disbursion of light. When the lure is submerged in water, an electrical circuit is established to activate the light emitting source. Another is U.S. Pat. No. 4,250,650, issued Feb. 17, 1981, to Raoul G. Fima for an Intermittently Illuminated Fishing Lure. That patent discloses a fishing lure containing one or more light sources and which includes an internal guide way along which a battery rolls back and forth in response to an occillatory movement of the lure. A series of stationary electrical contacts are positioned along the guide way to successively engage the moving battery to intermittently complete a circuit and energize the light sources. The light sources are mounted interally for protection of the lure body and the light is transmitted to exterior locations by optical conductors. A further one is U.S. Pat. No. 3,621,600 issued Nov. 23, 1971 to M. Dworski for a Fish Lure, and it discloses a lure which has a separate translucent head and body members which are assembled to the head either in the form of a series of disks or like halves assembled around an incandescent lamp and dry cell which weight the lure. Yet another is U.S. Pat. No. 3,608,228 issued Sept. 28, 1971, to R. W. Borreson, et al. for a Fishing Lure. That patent discloses a lure of the plug type comprised of hollow detachable sections which are provided with apparatus for illuminating the lure. Various weights may be positioned within the lure cavities, and the head section is formed of translucent material to provide a prismatic effect for the illumination means to form eye simulating areas on each side of the head section of the lure. Still further is U.S. Pat. No. 3,040,462 issued June 26, 1962, to F. C. Guida for a Luminescent Fishing Lure. That patent discloses a lure which has a pair of chambers, one of which contains a power source and the other of which contains a light emitting bulb which also projects into a third water filled chamber and illuminates the lure by transmitting light through the translucent body of the lure. Still another is disclosed in U.S. Pat. No. 2,121,114 issued June 21, 1938, to G. Beck for a Fish Lure. That device discloses a fish lure also having a translucent body within which a light emitting source is disposed for illuminating the lure. The present invention provides a simplified device which makes use of improved electronics for longer life and ease of construction to reduce cost as compared with the referenced prior art devices. A significant difference between the present invention and the known prior art is that in most cases the prior art devices must be disassembled to remove the battery in order to shut off the light emitter. They do not include a positive switch means for actuating the light sources from a position external to the lure or without immersing the lure in water. Because of the very hostile environment the lures are subjected to, it is very desirable to be able to check batteries and interal circuitry of an illuminable lure quickly. Fishermen also like to be able to change lures rapidly, and in order to accomplish this with the least loss of time, an external switch means is required to turn off the replaced lure and turn on the new one. Disassembly and assembly of lures, with their differing battery requirements, sizes, and parts to shut off and turn on a lure makes those procedures unsatisfactory in the most desired fishing environment. SUMMARY OF THE INVENTION The present invention is a light emitting fishing lure which includes a body portion having a cavity formed therein for containing one or more batteries. An electrical contact for establishing an electrical connection with the battery is formed integral to the cavity. The cavity includes means for urging the battery toward the front end or head portion of the lure. At least one fish hook is secured to the body portion of the lure. A head portion is provided which is securable to the body portion. The front end of the body portion is adapted to mate with the head portion in sealing relation to prevent water from entering the cavity portion of the body. An electrical contact for the battery of opposite polarity from the body portion contact is provided in the head to complete the electrical circuit for the lure. A switch means operable from a position external to the head and body portions is formed integral to the lure for activating the battery. At least one light emitting diode projects from the lure and is electrically connected to the battery and the switch means. OBJECTS OF THE INVENTION It is therefore an important object of the present invention to provide a simplified illuminated lure. It is another object of the present invention to provide an illuminated lure using light emitting diodes as simulated eyes or other features for the lure which flash on and off for increased fish attraction. And it is a further object of the present invention to provide an illuminated fishing lure which has an external switch to allow the light emitter to be turned on and off without assembly or disassembly of the lure and while it is held in the fisherman's hands. Other objects of the invention with become apparent when it is considered in conjunction with the accompanying drawings. DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the light emitting fishing lure of the present invention; FIG. 2 is a side elevation view in cross-section thereof taken along lines 2--2 of FIG. 1; FIG. 3 is a cross-section taken along lines 3--3 of FIG. 1; FIG. 4 is a partial top plan view of the head of the fishing lure; and FIG. 5 is a side elevation in cross-section of an alternative construction of the present invention taken along lines 2--2 of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1 and 2 disclose the light emitting fishing lure of the present invention. It includes a body portion 11 which has a cavity 13 formed therein for containing one or more batteries 15, and a head portion 17 which is securable to the body portion. The front end of the body portion of the lure is adapted to mate with the head portion 17 in sealing relation to prevent water from entering the cavity portion of the body 11. The head portion 17 of the lure is securable to the body portion by means of a threaded connection 19 which is made water tight by means of a gasket 21 in the form of a washer or "O" ring disposed around the threaded shank of the head portion and squeezed between the peripheral shoulders of the head and body portions 23, 25 respectively. The body portion 11 has an electrical contact integral thereto for making an electrical connection with the battery 15. In its simplest form that connection is comprised of a spring 27 which also is the means for urging the battery toward the head portion of the lure. The body portion 11 of the lure can be made of metal for conducting electrical current or of plastic with an internal electrical circuit such as a wire molded into it. The spring contacts the negative electrode or bottom of the battery, and the spring is in electrical contact with the body portion of the lure, if it is electrical conducting, by virtue of its fit in the small cavity 29 disposed at the rear end of the lure. This cavity is a female recess formed to hold the spring 27 therein with a friction fit so that when the battery is removed from the cavity, the spring remains in its predisposed position in the body of the lure at the rear end thereof. If the body is non-conducting, the internal electrical circuit is formed to contact the spring. In the preferred embodiment, the body of the lure is molded of plastic and an electrical wire 31 is placed in electrical contact with the spring. The front end of the body of the lure is formed with an annular collar 33 which is secured in the lure body by a tight fit and waterproof adhesive. The internal surface of the annular collar is provided with female threads for engaging the male threads on the head portion. The electrical wire 31 which is in electrical connection with the new spring 27 is attached to the collar 33 also with an electrical connection. The head portion 17 of the lure shown in FIG. 3 has an electrical contact 35 for engaging the battery which is of opposite polarity from the body portion contact. In the preferred embodiment, this contact 35 which engages the positive electrical contact 37 of the battery is a projecting stud which is imbedded in an epoxy matrix which forms the head portion 17 of the lure and insulates the post 35 from the head portion of the lure if it is coated with metal. The fixed post is in electrical contact with the positive leads 41 for the light emitting diodes (LEDs) 43 by being soldered thereto. The diodes, circuit wires, and electrical contacts all mold integrally into the head portion. When the head portion of the lure is screwed into the body portion, the projecting post 35 engages the positive contact of the battery 37 and remains in continuous engagement therewith by virtue of the spring 27 pressure. A switch means is provided integral to said lure for activating the battery from a position external to the lure. This is effected by an electrical contact which is a rotatable arm 45 that is secured to the head portion of the lure and is in electrical contact with the negative lead 47 of the circuit of the light emitting diode(s). The arm pivots on a journal shaft 49, such as a screw which threadably engages the head portion of the lure by means of a female receptacle stud 51 which is secured in the head portion matrix by a tight fit and waterproof adhesive. The respective ends of the negative 47 and positive leads 41 of the LEDs are soldered together before they are potted in the epoxy matrix of the head. In order to complete the electrical circuit and activate the diodes 43, the rotatable arm 45, which is electrically connected to the negative lead 47 of the light emitting diodes 43, is rotated into contact with the metal collar 33 of the body portion 11 of the lure, which is in electrical connection with the negative contact of the battery, establishing the electrical circuit. The negative and positive leads of the LEDs are insulated from each other by the epoxy matrix of the head portion. Thus, the rotatable arm 45, which can be rotated into and out of contact with the metal collar 33 of the body portion 11 of the lure, from outside of the lure, is the switch means for turning on and off the flashing light emitting diodes 43 by completing the electrical circuit. While the invention contemplates at least one light emitting diode 43 projecting from the lure and being electrically connected to the battery by the switch means, the preferred embodiment utilizes a pair of light emitting diodes which are disposed on, and epoxied into, opposite sides of the lure to project from the head portion thereof with semi-globular configurations for maximum light dispersion simulating a pair of eyes. Additional LEDs could be employed to simulate other features of a fish or simply be disposed at preferred locations to provide additional light emission sources. In the preferred embodiment the LEDs 43 are provided with a solid state circuit which interrupts the electrical flow to make the LEDs intermittent in their light emission. The preferred embodiment of the invention includes at least one fish hook 53 secured to the body 11 of the lure unless the line is just used as a fish attractor in which case a hook is unnecessary. The end of the shank 55 of the hook is provided with a groove 57 instead of an eye. A pin 59 which is force fitted through the body of the lure engages the groove of the fish hook and allows the hook to rotate in its connection to the lure body. The hook can be camouflaged by a rubber or plastic hula skirt disposed over the rear of the lure body and multiple and ganged hooks can be employed as with other lures. Thus, it will be seem from the description of the preferred embodiment of the present invention that all of the objects and advantages attributable thereto have been attained. While the invention has been described in considerable detail the invention is not to be limited to such details as have been set forth except as may be necessitated by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 10/759,211, filed on Jan. 20, 2004 now U.S. Pat. No. 6,964,428, the disclosure of which is hereby incorporated-by-reference thereto in its entirety and the priority of which is claimed under 35 U.S.C. 120. This application is based upon French Patent Application No. 03.00811, filed Jan. 21, 2003, the disclosure of which is hereby incorporated by reference thereto in its entirety and the priority of which is hereby claimed under 35 U.S.C. 119. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to a device for binding a boot, i.e., a boot or a shoe, to a sports article, particularly to a gliding apparatus such as a skate or a ski. More particularly, the invention relates to devices for binding a boot onto a ski. For example, the invention can be implemented for the design and construction of bindings for cross-country skiing, alpine or cross-country skiing, mountain skiing, and Telemark skiing. 2. Description of Background and Relevant Information As a first example of a binding of the aforementioned type is that of “hinge-type” cross-country ski bindings marketed by the assignee Salomon S. A. under the trademark “SNS PROFIL.” Another binding of the aforementioned type is that described in the document EP 768 103 and in U.S. Pat. No. 6,017,050, and which is found on certain cross-country ski binding devices marketed by the assignee under the trademark “SNS PILOT.” In both cases, the boot is articulated at its front end about a transverse axis in relation to the ski, which is provided by a retaining system forming a jaw in which a pivot rod affixed to the boot sole is received. The two systems differ by the design of the systems for the elastic return of the boot to a low position. The invention can also be applied to a device such as described in the document WO 00/13755 and U.S. Pat. No. 6,499,761, which boot retaining system is improved with respect to the prior binding systems. Indeed, the foot movement in relation to the ski, controlled by the retaining system when the heel is raised, is no longer a mere rotation and, instead, approximates a natural foot rolling movement as closely as possible. A device of the same type, more specifically dedicated to alpine cross-country skiing or Telemark skiing, is described in the patent publication EP 890 379. The principle of these devices is to allow a binding of the boot on the ski that is completely rigid in torsion, but which enables the heel of the boot to be raised freely. The invention can also be implemented for binding devices of the types described in the documents WO 96/37269, EP 914 44, and WO 01/93963, as well as in respective family member documents U.S. Pat. No. 6,113,111, U.S. Pat. No. 6,152,458, and U.S. patent application Publication No. 2003/0168830 A1. SUMMARY OF THE INVENTION An object of the invention is to improve upon all of the aforementioned types of bindings having in common a system for retaining the boot that is independent of an elastic return system. Indeed, particularly for cross-country skiing, it is necessary for the binding to have an elastic return system that returns the boot to the low position corresponding to its position when it is supported at the front and rear on the ski. This elastic return system must be sufficiently powerful to return the boot quickly to this low position. For example, when performing the skating step in cross-country skiing, this return occurs when, at the end of the thrust, the skier wishes to return the ski toward the front by lifting it from the snow. In this case, it appears that it is the front of the ski that the return system must return toward the top in relation to the position of the user's boot. If the return is not sufficiently powerful, the front end of the ski will be slow to rise and will run the risk of catching the snow, thus seriously disturbing the skier's progression. However, this elastic return system must also allow for a good progressive increase in the force depending upon the lift angle of the connecting member, and its action must not oppose too much resistance to the rolling movement of the foot. Another requirement that the elastic return system must meet is not to be too bulky or too heavy. In addition, with respect to construction, the elastic return system must be completely integrated into the remainder of the binding device. The bindings to which the invention applies are distinguished from cable bindings of the type described, for example, in the documents U.S. Pat. No. 3,863,942, WO 99/02226, FR 2 363 341, and U.S. Pat. No. 3,844,575. These cable bindings are generally adapted for alpine or Telemark skiing. In any case, they have an abutment arranged at the front, as well as a cable that is adapted to wind around the rear portion of the boot and to be tensioned in order to push the boot forward in support against the abutment. Although the cable can possibly cause an elastic return effect, this is not the primary effect desired and, generally speaking, it only occurs at the end of the boot flexion range. Indeed, the cable primarily serves as a member for retaining the boot within the retaining system constituted by the abutment and the cable. In this way, because the cable is primarily designed for its retaining function, the return is generally arranged near the boot flexion point, which is approximately the center of rotation of the boot heel movement in relation to the ski. As a result, because the return is arranged substantially in the area of this center of rotation, the cable only transmits a small displacement to the spring, and the variation in this displacement with respect to the angular position of the heel varies only slightly, and, in addition, this variation is not actually controlled. In this way, the variation in the return force cannot be completely controlled. For certain positions of the boot, the return force can be almost zero, even negative. It has been noted that it is not possible to have this control when the retaining system and the elastic return system are not independent, as in the cable bindings of the prior art in which, without the cable, the boot is no longer retained on the ski. In order to overcome these various drawbacks, the invention proposes a device for binding a boot to a sports article, of the type having a retaining system whereby the boot is fixed to the ski with a possibility of being displaced in relation to the sports article, between a low position and a high position; of the type having a system for the elastic return of the boot to its low position; and of the type in which the retaining system is independent of the elastic return system, wherein the elastic return systems has at least: an elastic member that is connected to the sports article; and a flexible linkage that connects the elastic member directly or indirectly to the boot, and which cooperates with at least one return member. BRIEF DESCRIPTION OF DRAWINGS Other features and advantages of the invention will become apparent from the following detailed description, with reference to the attached drawings, in which: FIG. 1 is a schematic side view of a first embodiment of a binding device according to the teachings of the invention, shown in the high position; FIG. 2 is a schematic side view of the device of FIG. 1 shown in the low position; FIG. 3 is a view, similar to that of FIG. 1 , showing a variation of the first embodiment of the invention; FIG. 4 is a perspective schematic view of a second embodiment of the invention; FIGS. 5 , 6 , and 7 are schematic views, in partial longitudinal cross-section, of the second embodiment of the invention, shown in an open state prior to fitting the boot, and in a closed state with the boot in the low position, then in the high position, respectively; FIGS. 8 and 9 are very schematic top and side views adapted to show how, by a cooperation of complementary forms, the hook of the elastic return system of the second embodiment is systematically returned to a predetermined position; FIG. 10 is a cross-sectional view along the line X-X of FIG. 9 ; FIG. 11 is a view, similar to that of FIG. 7 , showing an alternative embodiment of the invention incorporating an elastic abutment at the end of the boot travel. DETAILED DESCRIPTION OF THE INVENTION The invention will be described here with respect to the embodiments in which the binding device is more particularly adapted to cross-country skiing. However, as noted above, cross-country skiing is merely exemplary of the fields of endeavor to which the invention is intended to encompass. The first embodiment of a binding device 10 shown in FIGS. 1-3 has a base 12 that is adapted to be fixed to a sports article (not shown), such as a ski or skate, as described above, but which could also be incorporated directly therein as an insert or be unitary with a component thereof. In this first embodiment, the binding device 10 has a connecting member 14 on which a boot is adapted to be connected or integrated, such as by screws, rivets, or by being part of an insert for a sole of the boot or by being made unitary with the sole. This connection can be manifested by a detachable interface system, which could take the form of a “step-in” type interface system in which the connection of the boot on the connecting member 14 occurs automatically, for example, by a mere contact between the two. The disconnection can possibly require manual intervention by the user. As described in the document WO 00/13755 and U.S. Pat. No. 6,499,761, the disclosure of the latter of which is hereby incorporated by reference thereto in its entirety, particularly for a general understanding of the operation of such a binding, the connecting member 14 is provided to be fixed beneath the front portion of the boot, and to move between a low position shown in FIG. 2 (the connecting member, as well as the boot that is attached thereto, is then substantially horizontal) and a high position shown in FIG. 1 , when the user's heel is raised in relation to the sports article. The connecting member 14 is connected to the base by a rocker bar 16 that is rotationally mounted about two transverse axes A 1 and A 2 , possibly in the form of respective pins, on a block 13 , or projection, of the base 12 , on the one hand, and on the connecting member 14 , on the other hand. In the example shown, the rocker bar 16 is articulated by its rear end (with respect to the direction of the sports article) on the base 12 , and by its front end on the front end of the connecting member 14 , such that in the low position, the rocker bar and the connecting member are nested with respect to one another. To this end, one can provide, for example, that the connecting member 14 be made of two parallel elements that are offset transversely and joined by spacers, the rocker bar 16 then being received between the two parallel elements. The rocker bar 16 can also be designed in the form of two parallel elements spaced apart. One can also provide the rocker bar to be made of two parallel elements arranged on both sides of the connecting member 14 . However, the invention can also be implemented by arranging the rocker bar at the front of the connecting member, i.e., by articulating it by its front end on the base and by its rear end on the front end of the connecting member. During the lifting movement of the heel, when the connecting member 14 moves from its low position to its high position, the connecting member 14 is in support on the base by its front end which has a curved profile 19 on at least one portion. The form and development of the curved profile 19 provides for the height position of the axle A 2 in relation to the base 12 , depending upon the angular orientation of the connecting member. By an optimal design of the curved profile 19 , and by a judicious selection of the length and of the initial angle of the rocker bar 16 , one provides for the relative movement of the connecting member 14 in relation to the base 12 during the heel lifting phase. In the example shown, it can be noted that the angular movement of the rocker bar 16 is small, for example, on the order of 10-20 degrees, or approximately 10-20 degrees, when the connecting member 14 tilts over an angle of about 60 degrees, and that given the initial angle of the rocker bar, it translates into a small but actual forward displacement of the axis A 2 . It is noted that the lifting movement of the heel occurs due to a rolling movement with sliding of the curved profile 19 on the base 12 . The connecting member 14 , the rocker bar 16 , and the arrangement for connecting the boot on the connecting member are the main elements forming a retaining system whereby the boot is fixed to the sports article, and whereby the relative movement of the boot in relation to the sports article is determined. The binding device 10 also has a system for the elastic return of the boot to its low position, the retaining system being independent and distinct of the elastic return system. According to the teachings of the invention, the elastic return system has at least one elastic member that is connected to the sports article, and a flexible linkage that connects the elastic member to the boot, and which cooperates with at least one return member. In the first embodiment shown in FIGS. 1-3 , the flexible linkage is indirectly connected to the boot, in the sense that it is not directly connected on the boot, but rather it is connected to the connecting member. However, because the boot and the connecting member are in constant connection when this system is in use, this functionally leads to the same result. In the example shown in FIGS. 1-3 , the binding device 10 has a guiding ridge or rib 18 that is made of a profile having a generally parallelepipedic cross-section, and which extends longitudinally rearward, at the rear of the connecting member 14 . In a manner known in cross-country bindings, for example, this guiding ridge 18 is provided to cooperate with a groove having a complementary cross-section and arranged in the boot sole to ensure a lateral guiding of the boot/binding assembly. Advantageously, the elastic member 20 is integrated into a housing 22 arranged inside the ridge 18 . In this first embodiment, the elastic member 20 comprises a compression spring that is arranged horizontally and longitudinally in the housing 22 . The front end of the spring 20 is in support against a front surface 24 of the housing 22 . This front end of the spring is therefore fixed. The rear end of the spring is in support against a movable carriage 26 that can slide longitudinally in relation to the base 12 and to the ridge 18 . More specifically, the carriage 26 has a front end 27 that moves in the area of a front opening 29 of the housing 22 , and a rear end 31 that moves in the housing 22 , and on which the rear end of the spring 20 takes support. Such an arrangement of an elastic member and of a movable carriage is similar to that found in the device described in the document EP-768 103 and in certain cross-country ski binding devices marketed by the assignee Salomon S. A. under the trademark “SNS PILOT.” However, in contrast to this prior art in which the elastic member is connected to the boot by a rocker bar, the device according to the invention has a flexible linkage 30 that connects the elastic member 20 to the connecting member 14 . As can be seen in the drawing figures, the linkage 30 is not directly connected to the elastic member, but rather on the front end 27 of the carriage 26 . It passes over a guide or return 34 , or return member, which is constituted here of a pulley mounted on a block 13 , coaxially with the rocker bar 16 about the axis A 1 . The return could also be constituted of a mere slide, such as curved surface. In this embodiment, the return 34 is fixed in relation to the base 12 and in relation to the sports article. The other end of the linkage 30 is connected to the connecting member 14 such that the portion of the flexible linkage 30 that extends between the return 34 and the connecting member 14 is substantially vertical, such that the return force exerted on the connecting member 14 is mainly directed downward, i.e., primarily vertical (when the upper surface of the base is considered horizontal) including when the connecting member 14 is in the high position as shown in FIG. 1 . That is, as seen in FIG. 1 , for example, the linkage 30 has an orientation with a greater vertical component than horizontal component. Conversely, the portion of the linkage 30 that extends from the return to the elastic member 20 extends along a substantially horizontal direction, e.g., substantially parallel with the upper surface of the base 12 . As can be seen from FIGS. 1 and 2 , when the connecting member moves from its low position to its high position, the flexible linkage 30 moves lengthwise and pulls the movable carriage forward and causes the compression of the spring, which therefore provides a return force. According to a particular embodiment, the flexible linkage is substantially inextensible. For example, this can be a metallic cable or a cable made of fibers exhibiting very low extensibility, for example, a cable made of aramid fibers. One can also envision this link to be made in the form of a strip, such as a flat strip having a width much greater than its thickness. This traction strip can be obtained, for example, in the form of a metallic strip, or of a harness of parallel fibers embedded in a polymer material. In a particular embodiment, the linkage is sufficiently supple and flexible not to produce a notable elastic effect, and in particular, to support a return having an angle of about 90 degrees. Therefore, the flexibility of the linkage 30 should be generally understood as being the flexional flexibility about the return axis. This flexibility of the link cannot be only local, because the linkage moves in relation to the return. However, particularly if the flexible linkage is a strip, this strip will not be flexible in flexion about an axis perpendicular to the plane of the strip; but this will not prevent the strip from being considered as flexible in the context of the invention if it does not offer any substantial resistance to the flexion about the return axis. This flexibility requires that the transverse guiding of the boot be ensured by a distinct mechanism, in this case by the retaining system. In the example shown, the guiding mechanism is constituted, for example, by the rocker bar 16 and by the sliding surface 19 . However, the guiding mechanism could be designed differently, for example, in the form of a mechanism having a plurality of rocker bars as described in the document WO 96/37269 and U.S. Pat. No. 6,113,111. FIG. 3 shows a variation of the first embodiment of the invention, in which the return system according to the invention has a mechanism for adjusting the stiffness of the elastic member 20 , in order to provide the user with the possibility of increasing or reducing the intensity of the elastic return force to adapt it to his type of sporting activity. Thus, one can see that the front end of the spring is in support on an abutment 36 that is mounted in the housing, on a threaded portion 38 of a rod 40 . The rod 40 is mounted in the housing 22 so as to be rotationally movable about its longitudinal axis A 3 ; but it is stopped longitudinally in translation. Furthermore, it is seen that the rod 40 extends over the entire length of the housing 22 , such that it also ensures the guiding of the spring 20 (whose helical turns wind about the rod) and of the rear end of the carriage 26 on which the spring 20 takes support. Contrary to the spring 20 and to the carriage 26 which slide freely on the rod 38 , the abutment 36 is formed by a nut that is screwed on the threaded portion 38 of the rod 40 , and which cannot pivot about its longitudinal axis A 3 . The front end of the rod 40 extends out of the housing 22 and is in the form of a screw head 44 so as to enable the user to control the rotation of the rod 40 about its axis A 3 . In this way, due to this screw-nut system, the user can cause the longitudinal displacement of the abutment 36 in the housing in order to cause a more or less substantial prestress of the spring 20 . In the example shown, the guiding ridge 18 has a window 42 that enables the user to see the position of the abutment 36 and therefore to evaluate the spring prestress value. Graphical references can be associated with this window 42 . This elastic return system is particularly advantageous because it makes it possible to house the elastic member in a zone of the device where it does not hinder the kinematics and the foot rolling movement allowed by the binding. In this case, the elastic member is arranged toward the rear of the binding device, but it could also be provided to be arranged at the front thereof. The elastic member is therefore generally immovable with respect to the sports article, and it is only indirectly connected to the connecting member by the flexible linkage. In addition, because the latter passes over a return, a better orientation of the direction of the return force is obtained, which follows the direction of the portion of the flexible linkage that extends between the return and the boot. This orientation is substantially parallel to that of the trajectory that the boot must follow toward its low position. In the example shown, the spring is a compression spring, which requires the presence of the movable carriage. The invention could also be embodied as any of other types of elastic members, for example, with a traction spring, as will be described with respect to the second embodiment. In this first embodiment, one can ascertain that the system for retaining the boot remains independent of the elastic return system, even if, in this case, the flexible linkage (which is part of the return system) is connected to the connecting member, which is primarily part of the retaining system. This independence is ascertained by the fact that, even in the absence of the return system (for example in the case of a failure/breakage of the flexible linkage or of the elastic member), the retaining system continues to ensure fully its primary function of retaining the boot. FIGS. 4-7 show an assembly having a boot 46 and a binding device 10 according to a second embodiment of the invention. In this case, the boot has the conventional appearance of a cross-country ski boot 46 having a flexible sole provided, on the lower surface of its sole, with a longitudinal continuous groove adapted to cooperate with a continuous guiding ridge or rib 18 of the binding device 10 . Furthermore, this boot 46 has, at its front end, a front transverse connector, in the form of a bar 48 arranged across the groove and, set back from the front bar 48 , a second transverse bar 50 also arranged across the groove and located substantially in an area vertically beneath an area of the metatarso-phalangeal articulation zone of the user's foot, and at the most, at the rear limit of the first third along the length of the boot which constitutes the extreme rear limit of the metatarso-phalangeal articulation zone. Any position of the rear transverse bar 50 is possible between the front bar 48 and the rear limit defined hereinabove. The front bar 48 is preferably made in the form of a cylindrical rotatable rod adapted to cooperate, in a known manner, with a retaining system having a hook-shaped movable jaw 52 controlled by a lever 54 , and a front edge 56 of the base constituting a fixed jaw for the rotatable latching of the boot on the sports article. The principle of such a binding device is described, for example, in the patent publication FR 2 634 132 and in U.S. Pat. No. 5,085,454, which are commonly owned, and the disclosure of the latter of which is hereby incorporated by reference in its entirety, and which binding device can have either a manual closure, or a self-latching closure. Therefore, it will not be further described. The rear bar 50 is adapted to allow the direct connection of an elastic return system according to the invention on the sole of the boot. Indeed, a return system is found in this second embodiment, in which the elastic member 20 , in this case, a traction spring (i.e., a tension spring), is integrated into a housing 22 arranged within a guiding ridge 18 of the device and is connected by a rear end to the base 12 of the binding device. According to the invention, the front end of the elastic member is connected to a flexible linkage 30 that extends forward. The flexible linkage is provided at its front end with a hook 58 made of metal, for example. As can be seen in FIGS. 6 and 7 , the hook 58 is adapted to be connected to the rear bar 50 of the boot to ensure the connection of the elastic member 20 to the boot 46 , and therefore to enable the system to ensure its function of elastic return. Therefore, the hook 58 forms a connecting member between the flexible linkage and the boot, but this connecting member is only connected to the remainder of the binding device by the flexible linkage 30 . As in the first embodiment, the flexible linkage 30 passes beneath a return 34 (for example, made in the form of a pulley or a curved surface) which is arranged here in the area of the front opening 29 of the housing 22 . One of the difficulties to overcome in implementing this principle is to allow an easy and reliable connection and disconnection of the hook 58 on the rear bar 50 of the boot. Indeed, in contrast to the prior art example of the document EP 768 103 and U.S. Pat. No. 6,017,050, the hook 58 is arranged here at the end of a flexible linkage 30 which therefore cannot, alone, ensure a precise and predetermined positioning of the hook 58 in the absence of the boot 46 . Therefore, according to another aspect of the invention, the hook 58 has a guiding portion 60 that is adapted to cooperate with complementary surfaces of the base 12 of the binding so that, when the elastic member 20 returns the hook 58 to a resting position, by means of the lengthwise movement of the flexible linkage 30 , in the absence of the boot, the latter is guided and maintained in this predetermined position due to the cooperation of the guiding portion and of the associated shapes of the base. Furthermore, it is seen that the binding device also has a drawer/slide 62 which, controlled by the opening lever 54 , also cooperates with the guiding portion of the hook in order to bring the hook from its resting position to a waiting position enabling the positioning of the boot. Indeed, one can see in FIGS. 5-7 that the binding device has a drawer/slide 62 that is mounted to slide longitudinally on the base 12 of the binding, and whose front portion 61 is connected to the movable jaw 52 in order to follow the longitudinal movements thereof, which are controlled by the lever 54 . Thus, when the lever 54 is lifted to bring the binding into an open state, it is noted that the drawer/slide 62 advances longitudinally at the same time as the movable jaw 52 . However, the drawer/slide 62 has a rear portion 64 that is U-shaped in transverse cross-section and which, in the setback position of the drawer/slide 62 , extends within the through opening 29 of the housing 22 . With the adjacent walls 70 of this opening 29 , the U-shaped rear portion 64 thus demarcates shapes complementary to the guiding portion 60 of the hook 58 , as schematically shown in FIGS. 8-10 . The complementary shapes can include engagement ramps 66 , 68 , abutment surfaces 66 , or, in a non-limiting manner, lateral guiding surfaces 70 . Under the effect of the elastic member 20 , the flexible linkage 30 is retracted inside the housing 22 , through the opening 29 and, in the absence of the boot, it pulls the guiding portion 60 of the hook 58 along. The guiding portion is then automatically blocked against the complementary shapes of the base and of the drawer/slide, thus blocking the hook 58 in a predetermined position. From this predetermined resting position, the hook 58 can be displaced longitudinally forward by the rear portion 64 of the drawer/slide 62 when the latter is controlled forwardly when the user lifts the lever. In this waiting position, shown in FIG. 5 , the hook 58 is no longer capable of cooperating with the rear bar 50 of the boot, which can then be positioned (or instead removed). This positioning is done by engaging the front bar 48 of the sole between the two jaws 52 , 54 of the hinge, then by pivoting the sole of the boot 46 downward about the axis formed by hinge. When the boot is in the low position, in support both at the front and at the rear, the rear bar 50 has reached a position in which it is capable of being engaged by the hook 58 . At that moment, the user can close the binding by lowering the lever 54 , which results in locking the jaws of the hinge about the front bar 48 . At the same time, the drawer/slide 62 moves back and, under the return effect of the spring 20 , the hook 48 moves back until it hooks on the rear bar 50 (which is not necessarily a revolving cylinder) that is interposed on its path between its waiting and return positions. The assembly is then in the situation shown in FIG. 6 . If the user raises the heel of the boot, the latter makes a rotational movement about the axis of the hinge defined by the front bar 48 . At the same time, the rear bar 50 is raised along a substantially half-circle arc trajectory and, as shown in FIG. 7 , drives the hook 58 along with it, which causes the expansion of the spring 20 , in accordance with the same principle as that described with respect to the first embodiment. The operation of removing the boot is carried out in reverse direction from the positioning direction. When the boot 46 is the low position, the user opens the binding by raising the lever 54 , which causes the opening of the jaws 52 , 56 , on the one hand, and the advance of the drawer 62 , on the other hand. The latter, by its rear portion 64 , grips the guiding portion 60 of the hook 58 and drives the hook 58 forward, which frees the rear bar 50 from the boot. The two embodiments of the invention provide for a return system whose return force is completely controlled, the retention and the guiding of the movement of the boot being obtained by an independent system. One can thus provide the beginning of the lifting to be carried out with little initial return force, then to program the development curve of this force as a function of the lifting angle of the boot. To this end, the elastic member can be constituted of a plurality of serial and/or parallel springs, and/or it can also incorporate elastomeric elements having another type of force/deformation curve. Furthermore, in any case, the elastic return system can be completed by other elastic systems or abutment systems. Thus, one can provide a limit abutment 72 , as shown in FIG. 11 , which cooperates only at a predetermined lifting angle of the boot. This abutment 72 can be a rigid abutment that limits the travel of the boot, or an elastic abutment obtained in the form of an elastic buffer of the type described in the document FR 2 650 192 and in U.S. Pat. No. 5,152,546, the disclosure of the latter of which is incorporated by reference thereto in its entirety, which will then provide a flexible abutment effect and an additional elastic return force at the same time. The abutment 72 , whether rigid or elastic, can cooperate directly with the boot or with a portion of the retaining system, such as the connecting member 14 of the retaining device. In the illustrated form of the embodiment of FIG. 11 , the abutment 72 is positioned at a front end portion of the binding device and, when the boot is in the low position and, until the rear of the boot reaches a predetermined lifting angle, the abutment 72 is spaced from a front end of the boot. In the embodiments shown in the drawing figures, the guiding ridge 18 is integrated into the base 12 . However, one can provide that the guiding ridge be directly integrated into the sports article, for example, to the ski. In this case, the housing 22 , and the spring 20 (and, if necessary, the carriage 26 ) can be directly integrated into the sports article. Advantageously, this elastic return system can have a width on the order of 15-20 millimeters and can be completely integrated into the sole of the boot, so as to be housed, for example, in the space required by the groove that is found beneath the soles of cross-country skis. Furthermore, one can see that, in all of the embodiments shown, the return 34 is arranged at a short distance from the end of the flexible linkage that is connected to the boot (possibly by means of the connecting member), this being considered with the boot in the low position. The horizontal projection of this distance is preferably less than 3 centimeters, and even more preferably less than 2 centimeters. This proximity ensures that the effective return direction (which is the direction of the portion of the link that extends between the boot and the return) remains as close as possible to a parallel to the direction of the relative movement of the boot with respect the sports article (or close to the direction of a tangent to the trajectory of the boot, which is equivalent). Furthermore, both the end of the flexible linkage connected to the boot and the return are preferably arranged in an area vertically beneath the vicinity of the metatarso-phalangeal articulation zone of the user's foot when the boot is in the low position. Moreover, particularly in the cases where the boot retaining and guiding system determines a relative movement of the boot with respect to the sports article, which is a rotational movement or similar movement (as the second embodiment shown here), one must provide to arrange the return at a certain distance from the center of this rotational movement, otherwise the movement of the boot will cause only a slight displacement or no displacement of the end of the linkage that is connected to the elastic member, rendering the return system inefficient.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to equipment for making food items, and, more particularly, to pizza-making equipment, specifically to pizza sauce dispensers and methods of dispensing pizza sauce. 2. Description of Related Art Commercial kitchens and restaurants face the challenge of making large quantities of food items while maintaining the individual quality of each item prepared. For example, in a pizza restaurant, hundreds of pizzas are made daily. Naturally, this volume requires manually repeating the same preparation tasks (e.g., rolling or otherwise preparing dough, spreading sauce, adding toppings, etc.) over and over again. Manually applying and spreading sauce, however, leads to variability in the amount of sauce applied as well as variability in the spreading pattern. In other environments, such as a frozen pizza factory where thousands of pizzas are made daily, many of these repetitive tasks are automated. For example, a sauce dispenser is used to apply pizza sauce onto a pizza crust (e.g. unbaked dough flattened out to its desired shape and size). The dispenser deposits a predetermined amount (e.g. five ounces) of sauce onto the pizza crust. Such dispensers typically have a single sauce dispensing head and are sized to apply a single-sized portion of sauce. In other words, the dispensing head is capable of dispensing only a single volume of sauce, such as five ounces, rather than being capable of dispensing variable volumes, such as two ounces, three ounces, or even eight ounces of sauce. While generally useful in a factory setting, these types of dispensers are not helpful in a restaurant setting where many different sized pizzas (e.g., ten inch, twelve inch, sixteen inch diameter) are made, each requiring a different amount of sauce. If these factory-type sauce dispensers were used in the restaurant setting, a food service operator would be forced to change the dispensing head each time a different sized pizza was made. This required changeover would defeat any intended gains in efficiency. Moreover, in the restaurant setting, there are several types of pizza with different types of dough and different types of sauce. Since different sauces typically have different viscosities, a different dispensing head likely would be necessary since the flow rate of the conventional dispensing heads is fixed. While conventional sauce dispensing machines are capable of putting sauce on the pizza dough, the sauce still must be spread over the dough. In the factory setting, the typical conventional sauce dispenser drops a single dollop of sauce in the center of the dough and an automated roller rolls across the dough to spread the sauce about the surface of the dough. The roller frequently accumulates particulates from the sauce and dough, compromising the effectiveness of the roller and the appearance of the pizza. Moreover, a different roller is generally necessary for a different type sauce, to avoid cross-contamination of different sauces on the roller. Alternatively, in the retail restaurant setting, a food service operator spreads the sauce manually by hand, such as with a spoon or other cooking utensil. In the retail pizza business, using a roller or spoon to spread the sauce is undesirable since manual pressure applied against the pizza dough can damage the dough. This effect is particularly noticeable for pan pizza dough, which is very delicate. Undue pressure on this dough pushes air out of the dough, causing it to flatten and possibly harden in the area of contact. Of course, this type of damage is noticeable by the consumer and therefore is undesirable. Another conventional method of dispensing pizza sauce includes using a large multi-port dispensing head that sits over and above the pizza dough. Sauce drips through the ports, which are in a dot matrix or honeycomb pattern, down onto the dough. Unfortunately, selected portions of the multiple ports cannot be selectively deactivated, which would permit control over the pattern and volume of sauce applied to each pizza. Accordingly, this type of conventional, multi-port dispensing head is suitable only for saucing a single-sized pizza. A differently sized dispensing head or different machine would be required for each differently sized pizza. In addition, the ports tend to drip sauce even after the saucing operation is terminated, and the ports typically clog, thereby requiring frequent maintenance. Accordingly, conventional methods of applying sauce to pizza crusts in the restaurant setting suffer from several disadvantages. First, manual application and spreading of the sauce leads to variability in the volume of sauce applied and can damage the crust. Second, dispensing sauce through a factory-type sauce dispenser is impractical, because the conventional dispensing heads permit dispensing only a single volume of sauce (e.g., six-ounce portions only) and do not assist in spreading the sauce. Moreover, the rollers available in the factory setting damage some delicate crusts while spreading and present contamination issues where different types of sauces are used. Consequently, conventional factory-type sauce dispensers do not provide the desired efficiencies in the retail restaurant setting, and current manual preparation techniques remain inefficient and lead to variable quality. SUMMARY OF THE INVENTION A pizza sauce dispenser, according to an embodiment of the invention, simultaneously dispenses and spreads a precisely controlled amount of sauce onto a pizza dough base without requiring a food service operator to manually handle the sauce or the dough during operation. According to one embodiment, the dispenser includes a selectively rotatable disc, an arm that selectively pivots over the disc, and a spraying mechanism for spraying sauce onto the disc (or a pizza dough base on the disc). The rotatable disc includes a surface adapted to receive a pizza pan with dough thereon, for example. A nozzle of the spraying mechanism is disposed on an end of the arm and selectively deposits sauce onto the dough. Sauce is supplied to the nozzle by the remainder of the spraying mechanism, including a pumping system and reservoir. A control mechanism coordinates activation and deactivation of the rotatable disc, the pivotable arm, and the nozzle, and/or one or more of the following: (1) a selected rate of disc rotation; (2) a selected rate and selected directional pivoting of dispensing arm; and (3) a selected rate of dispensing sauce through the nozzle. To sauce a pizza dough base, a pizza dough/crust is placed on the disc, the disc is rotated and the dispensing arm can be pivoted simultaneously, so that the nozzle strikes a path from the outer edge of the dough to the center of the dough. While the arm is pivoting over the rotating dough (set on the disc), sauce is sprayed from the nozzle onto the dough, forming a spiral sauce pattern on the dough. The rotatable disc preferably includes a surface having a plurality of nested, concentric rings that match pizzas of different diameters, to permit the disc to instantly accept different sized pizza pans and/or dough bases. In addition, the concentric ring pattern results in automatic centering of the pizza pan (and dough thereon) on the sauce dispenser. The sauce dispensing system optionally includes a second spraying mechanism having a second nozzle, which also is mounted on the end of the pivoting arm, and a second pumping system with its own reservoir. This additional spraying mechanism permits instantaneous access to a second, different type of pizza sauce without requiring any changeover of the first spraying mechanism. Accordingly, a pizza sauce dispenser, according to an embodiment of the invention, automatically applies and spreads sauce onto a pizza dough for many different sized pizzas and multiple sauces, without requiring complicated changeovers of a dispensing head or other equipment, and without a roller, as is generally required with conventional sauce dispensers. Moreover, the sauce dispenser alleviates time pressure and the variable quality associated with pizzas that are sauced manually by food service operators. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the invention will be described with reference to the figures, in which like reference numerals denote like elements and in which: FIG. 1 is a perspective view of a pizza sauce dispenser, according to an embodiment of the invention; FIG. 2 is a schematic illustration, with sectional views, of the pizza sauce dispenser of FIG. 1, according to an embodiment of the invention; FIG. 3 is an enlarged perspective view of the dispenser of FIG. 1, according to an embodiment of the invention, and further incorporating a small pizza pan with dough; FIG. 4 is a perspective view of the dispenser of FIG. 1, according to an embodiment of the invention, and further incorporating a large pizza pan with dough; FIG. 5 is a top, generally schematic illustration of the dispenser of FIG. 1 in operation, according to an embodiment of the invention; FIG. 6 is a perspective view of the dispenser of FIG. 1, according to an embodiment of the invention, and further incorporating a pizza pan with dough and sauce applied by the dispenser onto the dough; FIG. 7 is a schematic top view of an additional sauce pumping system, according to an embodiment of the invention; FIG. 8 is a cross-sectional view of a rotatable disc of a pizza sauce dispenser, according to an embodiment of the invention; FIG. 9 is a schematic top view of a pizza sauce dispensing system including a stationary arm and multi-port nozzle, according to an embodiment of the invention; FIG. 10 is a schematic illustration of a pizza sauce dispensing arm, according to an embodiment of the invention; and FIG. 11 is a schematic illustration of a control mechanism of a pizza sauce dispenser, according to an alternate embodiment of the invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS A pizza sauce dispensing system 10 , according to an embodiment of the invention, is shown generally in FIG. 1 . System 10 includes base 11 , selectively rotatable disc 12 , dispensing arm 14 , which is selectively pivotable according to one embodiment, dispensing or spraying mechanism 15 with nozzle 16 and hose 17 , and controls 18 having display/keypad 20 . Rotatable disc 12 is adapted to receive a pizza pan, with a pizza crust thereon. Spraying mechanism 15 also includes a pumping system and sauce reservoir (not shown) for supplying pizza sauce to nozzle 16 . FIG. 2 is a schematic illustration of pizza sauce dispensing system 10 . As shown in FIG. 2, rotatable disc 12 includes tray 40 having an upper surface of nested, concentric rings 41 , center 42 and outer edge 44 with rim 46 . Rotatable disc 12 further includes motor engagement member 48 . In association with disc 12 , base 11 of system 10 further includes motor 50 having receptacle 52 for receiving base engagement member 48 . Motor 50 is in electrical and operative communication with controls 18 and programmable logic controller (PLC) 54 . Dispensing arm 14 further includes vertical support 60 , horizontal member 62 , first end 64 , second end 65 , and fasteners 68 . In association with arm 14 , base 11 of system 10 further includes motor 70 and sensor 72 , which are both in electrical and operative communication with controls 18 and PLC 54 . As also shown in FIG. 2, spraying mechanisim 15 further includes pump system 80 that supplies nozzle 16 with pizza sauce. Pump system 80 includes reservoir 82 and pump 84 having optional drawback cylinder 86 . Pump 84 is in electrical and operative communication with controls 18 and PLC 54 . Reservoir 82 is preferably refrigerated to lengthen the storage time of the pizza sauce. Rotatable disc 12 is removably attached to motor 50 and supported on base 11 via engagement member 48 , which is removably inserted in receptacle 52 . Motor 50 is preferably a stepper motor, or a motor known in the art for permitting selective clockwise or counterclockwise rotation of disc 12 relative to base 11 . Motor 50 can operate independently (e.g. as a direct drive motor for turntables) or in association with other motors and/or belts and pulleys, as known in the art, for providing selective rotation of disc 12 . Motor 50 receives commands from controls 18 and PLC 54 to determine the activation, deactivation, acceleration, and deceleration of rotation of disc 12 , particularly in relationship to the operation of dispensing arm 14 and spraying mechanism 15 . Dispensing arm 14 is pivotally mounted relative to base 11 , according to one embodiment. In particular, vertical support 60 is mounted to, and extends upwardly from, motor 70 of base 11 . Motor 70 is preferably a stepper motor and is capable of causing rotation of vertical support 60 in either a clockwise or counterclockwise rotation. As with motor 50 , motor 72 also can be another type motor that operates independently (e.g. a direct drive motor) or in association with accompanying belts, pulleys, etc., as known in the art, to achieve selective control over the activation, deactivation, acceleration, deceleration and the rate and direction of rotation of vertical support 60 . Sensor 72 acts in cooperation with motor 70 and PLC 54 to control the extent and direction of pivoting of vertical support 60 . Horizontal member 62 of dispensing arm 14 is connected to vertical support 60 in a generally perpendicular relationship, so that horizontal member 62 extends over rotatable disc 12 . Horizontal member 62 has a length (e.g. up to about ten inches) to ensure that first end 64 will be disposed over or adjacent to center 42 of tray 40 for the largest pizza (e.g. with a sixteen inch diameter dough base) that can be set in tray 40 of rotatable disc 12 . Vertical support 60 has a length sufficient to ensure that horizontal member 62 is vertically spaced from rotatable disc 12 . Horizontal member 62 also carries hose 17 along its length and fasteners 68 for securing hose 17 on member 62 from its first end 64 to second end 64 , and for securing nozzle 16 at second end 65 . Nozzle 16 of spraying mechanism 15 receives sauce for spraying or otherwise dispensing onto the pizza dough base via hose 17 and pumping system 80 . Pumping system 80 can comprise a commercially available condiment pumping system that includes a pump, regulator(s), air solenoid, and/or drawback cylinder, for example. Reservoir 82 , which preferably holds a large volume of sauce, is operably coupled to pump 84 . Drawback cylinder 86 is an optional component of system 80 and causes sauce to evacuate from nozzle 16 through hose 17 after pump 84 is deactivated to prevent dripping and clogging of sauce at nozzle 16 . Other pumping systems known in the art that provide the functions described herein can be readily used. Pump 84 is activated and deactivated selectively, and its flow rate controlled, by PLC 54 and controls 18 . Pumping system 80 also optionally includes a stepper motor that is incorporated into pump 84 , or operates in association with pump 84 , to facilitate control of a variable flow rate of sauce through hose 17 and nozzle 16 . For example, with this feature, it is believed the flow rate may be automatically decreased when less sauce is needed at a given location on the pizza crust (e.g. center) or increased when more sauce is needed at other locations on the pizza crust (e.g. outer edge). FIG. 3 shows dispensing arm 14 of sauce dispensing system 10 in a storage mode, and illustrates the automatic pan-centering feature of system 10 . Arm 14 is stationed adjacent to outer edge of disc 12 . A smaller size pan 110 with dough 111 thereon, such as a pan for a personal pan pizza, is placed concentrically relative to center 42 of nested rings 41 . Each one of the rings 41 is sized with a predetermined diameter and generally has a circular shape, to accommodate a predetermined size and shape of a pan, such as pan 110 . Since rings 41 are concentrically arranged, once pan 110 is set within its matching diameter-sized ring 41 , pan 110 is automatically centered on rotatable disc 12 . FIG. 4 shows sauce dispensing system 10 just prior to use, according to one embodiment. In this example, a larger size pan 120 with dough 122 is set on rotatable disc 12 , in one of the rings 41 that matches the diameter of pan 120 . Pan 120 is automatically centered, as described above, by the concentricity of rings 41 . Using controls 18 , a saucing operation is started. In particular, the diameter size of pan 120 , type and volume of sauce, and type of dough is identified at controls 18 (as well as other parameters). Optimally, this identification at controls 18 occurs by pressing a single key on keypad 20 or via bar code scanning, as will be further described. This information is entered into, or recalled from memory, in PLC 54 . PLC 54 then identifies several parameters regarding the saucing operation for that identified pizza, including a starting location adjacent the outer edge on the dough and an ending location adjacent the center of the dough. Additional parameters of the pre-programmed operation can include: (1) the total time, rate, and/or direction that disc 12 rotates throughout the operation; (2) the total time, rate, and/or direction (counterclockwise or clockwise) that arm 14 pivots over disc 12 ; and (3) the total time, rate, and time of initiation and termination of sauce flowing through nozzle 16 of spraying mechanism 15 . PLC 54 is programmed for these parameters using well known principles of kinematics for a rotating disc, pivoting arm, and vertically dropping liquid, for example including the use of the following equations: W =2 πN /60=0.10472 N (in rad/sec), where N =RPM, and  (1) T =2π/ω, where T is equal to the time required to complete one full cycle.  (2) Using the pressure of the sauce spraying mechanism 15 , the volume of sauce to be sprayed, the desired sauce pattern on the pizza, and the above equations and familiar kinematic principles, a program for activation, deactivation, and rate control of rotatable disc 12 , pivotable arm 14 , and spraying mechanism 15 is stored in PLC 54 for later activation. Ideally, each program for a given pizza results in the time to complete one cycle, including the time to sauce a pizza, being less than nine seconds. After this information is registered in PLC 54 for saucing the dough on pan 120 , operation begins with arm 12 pivoting so that nozzle 16 is located at a predetermined site above dough 122 adjacent an outer edge 131 of dough 122 (e.g., one-quarter inch from an outer edge of the pizza). In a single step, according to one embodiment, disc 12 begins rotating as arm 12 pivots inward and sauce sprays out of nozzle 16 onto dough 122 . FIG. 5 schematically illustrates the interaction of disc 12 and arm 14 as sauce 17 is deposited on dough 122 (resting on tray 40 of rotatable disc 12 ). While sauce is being deposited on dough 122 , disc 12 rotates in a counterclockwise direction (identified by directional arrow A) and arm 14 pivots in a counterclockwise direction (directional arrow B) from an outer position 130 (identified by phantom lines) adjacent outer edge 131 of dough 122 to a center position 132 adjacent center 42 of disc 12 and/or dough 122 . If desired, sauce 17 also can be deposited when arm 14 pivots from its center position 132 to outer position 130 . This return movement is identified by directional arrow C. As seen in e.g. FIG. 5, this operation results in sauce 17 forming a spiral pattern 133 on dough 122 . As described above, PLC 54 is programmed so that an exact start location and an ending location of arm 14 , as well as other identified parameters, during the saucing operation are used for each differently sized pizza, type of pizza and type of sauce. For example, a twelve-inch pan pizza might require about 4.25 ounces of sauce to be deposited over a dough having a surface area diameter of about 10.5 inches. In addition, the pan pizza might require that saucing start about one-quarter inch from outer edge 131 of the dough 122 and use sauce type “A.” Using this criteria and accounting for the speed of rotation of any given point on disc 12 using well known principles of kinematics, the preprogrammed PLC 54 initiates and variably maintains the spraying rate of nozzle 16 (by controlling the rate and/or activation and deactivation of pump 84 ), the rate of rotation of disc 12 and the rate of pivoting and direction of arm 14 . In another example, such as for a different brand pizza, PLC 54 would be preprogrammed to start saucing at about three-quarters of an inch from outer edge 131 of the dough 122 , and/or use sauce type “B.” Finally, in another example, for thin pizza, PLC 54 would be preprogrammed to start saucing at the lip of dough 122 , with one or more of sauce types “A” and “B”, and/or additional sauce types. Of course, for each of the types of pizza, the starting location is achieved by pivoting arm 14 . By using sensor 72 at vertical support 60 of dispensing arm 14 , PLC 54 determines the position of arm 14 relative to outer edge of disc 12 and/or relative to center 42 of the tray 40 . As shown in FIG. 6 and using the above-described method with sauce dispensing system 10 , sauce 17 is distributed evenly over the surface of dough 122 in the exact volume required and without manually handling the sauce or manually spreading the sauce on the dough. This technique is fast and prevents damage to dough since no mechanical force presses downwardly against dough 122 . FIG. 7 shows an optional second spraying mechanism 90 having reservoir 91 , pump 92 , hose 94 , and nozzle 96 . Second spraying mechanism 90 is in electrical and/or operative communication with controls 18 , including PLC 54 . Having second spraying mechanism 90 , in addition to spraying mechanism 15 , allows system 10 to instantaneously apply different types of sauces without changing nozzle 16 , pump 84 or reservoir 82 of pump system 80 . PLC 54 is programmed to selectively activate one or both of pump system 90 and pump system 80 to achieve the desired saucing. As seen in FIG. 7, spraying mechanisms 15 and 90 , particularly nozzle 16 and 96 are arranged side by side on dispensing arm 14 . Of course, more than two spraying mechanisms can be used. For example, if a third or fourth type of sauce is available, a third and fourth spraying mechanism, or portions thereof (e.g. a nozzle or reservoir), can be operably connected to controls 18 and PLC 54 for selectively operating the extra spraying mechanisms. Moreover, if desired, two types of sauces can be applied to a dough base simultaneously or in succession, again without changing hardware or other features of the system. FIG. 8 shows, in greater detail, the nested concentrically arranged rings 41 of tray 40 according to one embodiment. In particular, disc 12 includes optional lower base 141 and removable upper tray 142 . Tray 142 includes rim 144 , center 146 , and large-sized diameter ring 152 , medium-sized diameter ring 154 , and small-sized diameter ring 156 . Tray 142 preferably has an overall height h 1 of about two and one-half inches to maintain a space saving low profile. Each ring 41 of tray 142 (e.g., ring 154 ) has a height h 2 (which may be the same as or different than other rings 41 ) to act as a border to contain the pizza pan that matches the diameter of that ring. Height h 2 is preferably 0.125 inches, according to one embodiment, to allow the entire tray 142 to have a low profile. Of course, a wide variety of dimensions are contemplated according to the invention, for this and other features described herein. Tray 142 optionally is formed integrally with lower base 141 . Tray 142 , with or without base 141 , is preferably removable from base 11 of system 10 to permit easy washing and maintenance of tray 142 . Of course, tray 142 can be formed with any number of rings 41 (more or less than rings 152 , 154 , 156 ), with each ring 41 having a predetermined diameter that matches the diameter of an available pizza pan. Tray 142 is preferably made from a plastic material for easy and inexpensive manufacture, lightweight handling, and convenient washing, although other materials will be apparent for use, of course. FIG. 9 shows pizza sauce dispensing system 200 , according to an alternate embodiment of the invention. System 200 uses rotatable disc 12 and includes stationary arm 201 , inner multi-port nozzle 202 , intermediate multi-port nozzle 204 , and outer multi-port nozzle 206 . Each nozzle 202 , 204 , 206 has its own hose 208 and solenoid 210 . Of course, system 200 further includes controls 18 with PLC 54 and sauce pumping system 215 with reservoir 216 (similar to pump system 80 ) or other pumping systems known in the art. Sauce pumping system 215 is in fluid communication with each hose 208 to supply sauce to nozzles 202 , 204 , and 206 . In addition, as previously described for sauce dispensing system 10 , controls 18 with PLC 54 coordinate the rotation of disc 12 , and activation/deactivation and spray rate of nozzles 202 , 204 , 206 to achieve the selected amount of sauce deposited at the selected thickness and spacing on the pizza crust. In use, arm 201 is stationary while sauce is sprayed from nozzles 202 , 204 , and 206 as rotatable disc 12 rotates underneath arm 201 . For pizzas having smaller diameters, only inner multi-port nozzle 202 is activated to spray sauce on disc 12 while disc 12 rotates through a single revolution. For pizzas with intermediate size diameters, both inner multi-port nozzle 202 and intermediate multi-port 204 are activated to spray sauce on disc 12 while disc 12 rotates through a single revolution. Finally, for pizzas with larger diameters, all three of the inner, intermediate and outer multi-port nozzles 202 , 204 , 206 are activated to spray sauce on disc 12 while disc 12 rotates through a single revolution. Of course, multiple revolutions instead of single revolutions are also contemplated according to the invention. FIG. 10 also schematically illustrates a sauce dispensing system 220 , according to an alternate embodiment of the invention. System 200 includes stationary bracket 221 , slidable member 222 , nozzle 224 , and rotatable disc 226 . Nozzle 224 of system 220 is supplied with sauce from a pump and reservoir system (not shown) substantially similar to pumping system 80 as previously described in connection with FIG. 2 . In this example, sauce is sprayed from nozzle 224 onto rotating disc 226 (with dough thereon), while slidable member 222 selectively slides along bracket 221 from an outer edge of disc 226 to a center of disc 226 , and/or conversely from a center of disc 226 to its outer edge. This arrangement also causes sauce to be deposited in a spiral pattern onto dough on disc 226 , if desired. In addition, as previously described for sauce dispensing system 10 , controls 18 with PLC 54 coordinate the rotation of disc 226 , sliding of member 222 , and activation/deactivation and spray rate of nozzle 224 to achieve the selected amount of sauce deposited at the selected thickness and spacing on the pizza crust. Finally, controls 18 , previously shown in FIG. 2, are further illustrated according to one embodiment in FIG. 11 . Controls 18 include display 250 , manual start 252 , stop 254 , reset 256 , power 258 , operation light 260 , and program selection arrows 262 . Controls 18 also include a communications port 264 (such as a RS232 or other known communication mode, e.g. Ethernet), and associated programming in PLC 54 for receiving and operating with optional bar code scanner 270 . Finally, a membrane-type keypad 280 permits saucing a pizza by identifying a type of pizza sauce and size of pizza with the touch of a single button. To operate system sauce dispensing system 10 using optional bar code scanner 270 , a pizza dough to be sauced will carry a unique bar code ticket that identifies parameters such as a predetermined diameter, sauce type and dough type, or more simply that identifies a preprogrammed saucing operation for that type of pizza. An operator scans the bar code ticket using bar code scanner 270 , thereby registering the selected parameters with the PLC, or identifying the preprogrammed saucing operation within PLC 54 . Updates or changes to programs for running saucing operations can be obtained online, e.g. through the Internet, according to one embodiment, and then downloaded into PLC 54 . Of course, such updates or changes also can be supplied by disk, telephone modem or other known data-transfer devices and methods. Updates can include refinements in coordinating disc rotation and arm pivoting, and/or can include supplying a new set of parameters for applying sauce for a new size or type of pizza and/or type of sauce. The programmable logic controller (PLC) 54 also permits counting the number of pizzas sauced and to be sauced, as well as recording their types, for coordination with e.g. cleaning or maintenance requirements for the system, reservoir replenishment, etc. Since this information can be displayed on display 250 , these features greatly facilitate the preparation of a large number of pizzas having different characteristics. Pizza sauce dispensing systems according to embodiments of the invention provide many advantageous features. First, such systems allow a precisely controlled amount of sauce to be deposited on a pizza dough, in a predetermined pattern, without manually handling the sauce during application and without manual spreading. Second, by using multiple pumping systems, embodiments of the invention permit at least two different sauces to be applied without requiring a change in a dispensing head, pump, or reservoir. Third, the programmable logic controller permits customization of sauce operations that are not practical with factory-type sauce dispensers, to permit saucing a high volume of pizzas while still accommodating different sized pizzas and different sauces. Finally, the sauce dispensing system saves space by allowing several types of pizza to be rapidly made in the space of a single pizza make table. Other advantages will be apparent to those of ordinary skill upon reading this disclosure. While the invention has been described with reference to specific embodiments, the description is illustrative and is not to be construed as limiting the scope of the invention. For example, although embodiments of the invention have been described with respect to pizza, pizza sauce, pizza pans and pizza toppings, the invention is applicable to the preparation of other food items as well. Similarly, references to dough and dough bases should be interpreted to include other edible and inedible platforms for receiving food substances or other substances in the manner disclosed and contemplated herein. Other devices and methods according to the invention will be apparent to those of ordinary skill without departing from the spirit and scope of the invention.

1a

TECHNICAL FIELD [0001] The invention relates to an osteogenic matrix composite of collagen and noncollagenic components of the extracellular matrix (ECM components), a method for its production, a method for the production of an implant or of a scaffold for tissue engineering having a coating of an osteogenic matrix composite, and implants and scaffolds for tissue engineering having a coating of the osteogenic matrix composite for the stimulation and accelerated formation of hard tissue, such as, for example, in the field of osseointegration of implants into bone. BACKGROUND ART [0002] In the tissue, the cells are embedded in the native extracellular matrix (ECM), which is an important part of the cellular environment. The native ECM is a highly ordered, tissue-specific network which consists of collagens, glycoproteins, proteoglycans and glycosaminoglycans (GAG). The composition for various tissue and for various stages of development is very different here, such that the respective matrix has specific properties with respect to interaction with cells and growth factors. [0003] The main structural protein of the native bone matrix is collagen type I, but various other matrix proteins such as proteoglycans and glycoproteins can interact with the collagen and influence the structure and function of the matrix. These noncollagenic ECM proteins fulfill specific functions in the matrix. Thus fibronectin, in addition to cell-binding properties, also has collagen- and GAG-binding properties [Stamatoglou and Keller, 1984 , Biochim Biophys Acta. Oct. 28; 719(1): 90-7], whereas small leucine-rich proteins (SLRPS) such as decorin not only play a role in the organization of the native ECM (decorin modulates fibrilogenesis in vivo), but also bind growth factors such as TGF-β or even play a role as signal molecules [Kresse and Schönherr, 2001, J Cell Phys 189: 266-274]. [0004] Proteoglycans and glycoproteins differ by their degree of glycosylation, the sugar content of the particularly highly glycosylated proteoglycans consisting of various glycosaminoglycans. The distribution of these chains can be tissue-specific, as, for example, for decorin (chondroitin sulfate in the bone, dermatan sulfate in the skin). The glycosaminoglycans are large, unbranched polysaccharides which consist of repeating disaccharides, which are composed, for example, of N-acetyl-galactosamine, N-acetylglucosamine, glucuronate or iduronate, which are sulfated to different degrees. The sugar chains are present in vivo bound to the proteoglycans and play an important role in the function of these proteins, i.e. in growth factor binding and modulation [Bernfield et al, 1999, Annu Rev Biochem, 68: 729-771]. [0005] Individual ECM constituents, in particular collagen, are already utilized for the biocompatible modification of scaffolds and implants in order to improve cell adhesion and tissue integration. In addition to collagen, further ECM components such as polysaccharides are used in various applications. Thus bone tissue was crosslinked with glycosaminoglycans in order to produce a three-dimensional scaffold for applications in tissue culture (WO 01/02030A2). [0006] A chondroitin sulfate-containing mixture is used for the repair of bone defects; this promotes the healing of the connective tissue, mainly on account of the content of aminosugars and increased matrix production caused thereby (WO 98/27988, WO 99/39757). In combination with collagen, plant polysaccharides are used as wound coverings (EP 0140569 A2), and a combination of chitosan and GAGs is described as an agent for the stimulation of the regeneration of hard tissue (WO 96/02259). Collagen-GAG mixtures are produced here by acid coprecipitation, an unstructured precipitate and no defined collagen fibrils comparable to those in the native ECM being formed (U.S. Pat. No. 4,448,718, U.S. Pat. No. 5,716,411, U.S. Pat. No. 6,340,369). [0007] With progressive availability of recombinant growth factors, those osteoinductive factors which actively influence the interactions between implants and surrounding tissue are increasingly of interest for implant applications [Anselme K (2000). Biomaterials. 21, 667-68]. In connection with bone healing, the ‘bone morphogenetic proteins’ (BMP 2, 4-7) are particularly interesting since they induce the differentiation of mesenchymal stem cells in chondrocytes and osteoblasts and the formation of new bone [Celeste A J, Taylor R, Yamaji N, Wang J, Ross J, Wozney J M ( 1994 ) J. Cell Biochem. 16F, 100; Wozney J M, Rosen V (1993) Bone morphogenetic proteins in Mundy, G R, Martin T J (Ed.) Physiology and pharmacology of bone. Handbook of experimental pharmacology, Vol. 107. Springer Verlag, Berlin, 725-748]. On account of these strong bone-inducing effects, recombinant BMPs are employed in various carrier materials in order to promote and to improve the regeneration of bone. Effective carriers for morphogenetic proteins should bind these, protect against hydrolysis, make possible subsequent, controlled release and promote the associated cell reactions. Moreover, such carriers should be biocompatible and biodegradable. Preferred carrier materials for BMPs are, for example, xenogenic bone matrix (WO 99/39757) or natural tissue subsequently crosslinked with GAGs (WO 01/02030 A2), or HAP, collagen, TCP, methylcellulose, PLA, PGA, and various copolymers (EP 0309241 A2, DE 19890329, EP 0309241 A2, DE 19890906, WO 8904646 A1, DE 19890601). Further applications comprise a crosslinked synthetic polymer which can contain additional components such as GAGs, collagen or bioactive factors (WO 97/22371), or crosslinked collagen mixed with glycosaminoglycans and osteogenic factors (WO 91/18558, WO 97/21447). The collagen-GAG mixture is in this case likewise produced by acid coprecipitation. [0008] The use of recombinant growth factors is associated with great disadvantages. Since the recombinant factors usually have a lower activity than the endogenous factors occurring naturally in the tissue, in order to achieve an effect in vivo unphysiologically high doses are necessary. The administration of recombinant factors can only simulate the action of endogenous factors very incompletely. [0009] By the use of factors which promote the action of the BMPs (Bone morphogenetic protein), or by the use of cells which can express the growth factors in situ, it is attempted to minimize or to circumvent this problem (WO 97/21447, WO 98/25460). Further problems can result from the fact that receptors for BMP occur in many different tissues; the function of these growth factors is thus not limited to the bone. SUMMARY OF THE INVENTION [0010] It is the object of the present invention to specify a biocompatible and biodegradable matrix composite which promotes and accelerates bone accumulation and bone growth in the immediate environment and on the surface of implants coated with the matrix composite, and which can be used in particular for the coating of synthetic, metallic or ceramic implants. A further aim of the invention is a coating of carrier materials (scaffolds) for tissue engineering, which assists the production of hard tissue in vitro and subsequently in vivo. [0011] The invention is based on the scientific observation that for implants in contact with the bone in most cases an adequate amount of endogenous bone-forming factors is present on account of the surrounding tissue and the blood circulation. The bone-inducing effect of the BMPs, which can be observed under physiological conditions in vivo, is in all probability also not due to an individual growth factor type, but the result of the synergistic action of a large number of endogenous factors. [0012] Against this background, an implant coating is desirable which advantageously utilizes the endogenous bone-forming factors which are present at the implantation site. [0013] According to the invention, the object is achieved by an osteogenic matrix composite of collagen and at least one noncollagenic ECM component or its derivatives, in which the collagen component consists of non-crosslinked collagen fibrils produced by means of fibrillogenesis, into which are integrated the at least one noncollagenic ECM component or its derivatives. [0014] For the osteogenic matrix composite, according to the invention constituents of the extracellular matrix are used which are as similar as possible in composition and morphology to the matrix constituents which occur naturally in the bone, which are biocompatible and biodegradable, and have bone tissue-specific functions both in the binding and presentation of growth factors, and can directly influence the reactions of the cells. As a result, a microenvironment which is as approximate as possible to the in vivo conditions is presented to the cells, which positively influences the cell functions and the reaction to bone-forming factors such as growth factors. [0015] The term collagen comprises all fibril-forming collagen types. Any collagen source is suitable which produces noncrosslinked, acid-soluble collagen monomers, recombinant or tissue derived, with and without telopeptides. [0016] The term noncollagenic ECM components comprises both glycosaminoglycans and noncollagenic proteins, which are known constituents of the native ECM. [0017] The term noncollagenic proteins comprises all matrix proteins having noncollagenic (proteoglycans and glycoproteins) or partly collagenic (FACITs) structure. [0018] The main constituent of the osteogenic matrix composite is collagen of type I, II, III, V, IX, XI, or combinations thereof. In principle, every fibril-forming collagen type can be used which produces noncrosslinked, acid-soluble collagen monomers, collagen I, III and V being preferred, since these are the collagens mainly represented in the bone. [0019] As GAG components, the osteogenic matrix composition contains chondroitin sulfate A, C, D, E; dermatan sulfate, keratan sulfate, heparan sulfate, heparin, hyaluronic acid or their derivatives, both individually and mixed, chondroitin sulfate being preferred. The sugars used are either prepared synthetically or isolated from biological sources. [0020] As further noncollagenic matrix proteins, the osteogenic matrix composition can contain fibronectin, decorin, biglycan, laminin or versican, both individually and mixed, decorin and biglycan being preferred. The proteins used are either prepared recombinantly or isolated from biological sources in native form. [0021] In order to generate a matrix which is as bone-analogous as possible, preferably collagen type I, decorin and biglycan and/or their GAG chains such as chondroitin sulfate are employed. Decorin or biglycan are used here in order to utilize bonds or synergisms between matrix, growth factor and cell. A further possibility, which is given preference here, is the use of GAG chains, which bind endogenous growth factors or can potentiate in their action; in particular the chondroitin sulfate frequently occurring in the bone. By combination of collagen with further GAGs or matrix constituents, further endogenous growth factors can also be used for accelerated healing, such as, for example, VEGF by heparan sulfate for the promotion of invascularization. [0022] According to the invention, an osteogenic matrix composite of collagen and at least one noncollagenic ECM component or its derivatives is prepared such that collagen fibrils are produced by means of fibrillogenesis and that prior to fibrillogenesis at least one noncollagenic ECM component or its derivatives is added. [0023] The collagen fibrils produced in this way can be utilized as a coating solution after resuspension in water or in a buffer system or lyophilized. [0024] The fibrillogenesis (i.e. the formation of collagen fibrils) proceeds under the following conditions: temperature range from 4° C. to 40° C., preferably 25° C. to 37° C., collagen concentration of 50 to 5000 μg/ml, preferably 250 to 1000 μg/ml, pH 4 to pH 9, preferably pH 6 to pH 8, phosphate content up to 500 mmol/l, preferably 30 to 60 mmol/l, NaCl content up to 1000 mmol/l, preferably up to 300 mmol/l. [0025] By means of the preparation method according to the invention, an osteogenic matrix composite is formed having a defined structure and composition comparable to the situation in the native ECM. [0026] An ordered, mutually transposed lateral association of the collagen monomers is characteristic of collagen fibrils in vivo, a typical band pattern having a periodicity of 64 to 67 nm resulting. This association is due, inter alia, to the charge pattern of the monomers. Fibril formation in vitro is induced by the pH, the temperature and the ionic strength of a cold, acidic collagen solution being brought to values in the vicinity of the physiological parameters. [0027] Glycosaminoglycans or other matrix components are added to the solution containing collagen monomers before fibrillogenesis and thereby included in the following process of fibrillogenesis. Owing to the presence of the noncollagenic ECM components during the fibrillogenesis, these are integrated into the resulting fibril and a matrix is formed which corresponds to the native ECM with respect to the components used, the composition and structure. [0028] During fibrillogenesis in vitro, collagen forms the characteristic transversely striated fibrils analogously to the in vivo-structures, the structure of the resulting fibrils being influenced by the process parameters (pH, ionic strength, phosphate concentration) and by the nature and amount of the noncollagenic components present in the reaction solution. For in vivo matrix-modifying proteoglycans such as decorin, the greatest possible approximation to the native biological function is obtained in this way, as they can in this way also influence the structure of the resulting fibrils under in vitro conditions. [0029] In contrast to structure formation, as a result of aggregation by fibrillogenesis collagen aggregation can also be induced by the addition of a polyanion, as the glycosaminoglycans represent, in the acidic medium, the electrostatic interactions existing between the GAG and the collagen monomer being causal. In such an acid precipitate, the association of the collagen monomers cannot be compared with that under approximately physiological conditions. Either an amorphous precipitate is formed or, with appropriate quantitative ratios and sufficient agreement of the charge patterns, a polymorphous aggregate such as segment long-spacing crystallites is formed. [0030] For glycoproteins or proteoglycans such as decorin, there is no possibility of precipitation from the acidic medium. [0031] In order to remain as close as possible to the conditions in vivo, according to the invention the collagen fibrils are not crosslinked. Although crosslinking would increase the stability, it would disadvantageously have an effect on those domains which can enter into specific bonds with endogenous bone-forming factors. This is in particular of importance for the function of the GAGs, since their growth factor-binding properties are based on free mobility of the sugar chain, which is restricted by the crosslinking. At the same time, the sugars can thus be released from the matrix, which is of importance for the presentation of the growth factors to the cell surface. [0032] The invention comprises the use of the osteogenic matrix composite according to the invention for the coating of implants or scaffolds for tissue engineering. [0033] Implants in the sense of the invention is understood as meaning all metallic, ceramic and polymeric implants or implants composed of various groups of materials whose surfaces are at least partly in contact with bone tissue. Likewise all metallic, ceramic and polymeric structures or structures composed of various groups of materials which serve as a scaffold for the tissue engineering of hard tissue. [0034] The previously described osteogenic matrix composite is suitable, in particular, for the coating of nondegradable implants in bone contact, such as artificial hip joints, tooth implants or other load-bearing applications for which a rapid and solid integration of the implant into the bone is necessary. [0035] The osteogenic matrix in -combination with a three-dimensional, degradable implant, which is implanted as a bone replacement, can advantageously accelerate the integration and the reconstruction of the implant and also the new bone formation. These implants can contain, for example, particulate or three-dimensional structures consisting of calcium phosphates, but also polymeric materials, as a basic component. [0036] For tissue engineering, the osteogenic matrix composition in combination with a scaffold can be advantageous for proliferation and differentiation of the bone-forming cells. As a scaffold, all three-dimensional, porous structures of synthetic and/or natural polymers (e.g. collagen), ceramic or metal individually or in combination are possible, biodegradable scaffolds of polymer and/or ceramic being given preference. [0037] By means of the osteogenic matrix composite, bone-forming factors, such as, for example, growth factors which are present in vivo, are bound to the surface of the implant after implantation and their activity is increased. Advantageously, different endogenous factors which are present at the implantation site are recruited by the implant coated with the osteogenic matrix composite. [0038] For the production of an implant or of a scaffold for tissue engineering, the coating solution comprising the osteogenic matrix composite is utilized in order to immobilize the osteogenic matrix composite on its surface advantageously by means of a dip-coating process. The collagen concentration of the coating solution can be between 0.5 mg/ml to 5 mg/ml, 1 mg/ml to 2 mg/ml being the preferred range. The osteogenic matrix composite is immobilized by incubation of the implant at room temperature for 5 to 20 minutes, subsequently dried and washed with water. The thickness of the resulting layer can be influenced by the concentration of the coating solution and by the number of process repetitions. [0039] For the generation of a coated three-dimensional scaffold in combination with the described osteogenic matrix composite, the component mixture is advantageously introduced into the scaffold, which can be of metallic, ceramic and/or polymeric origin, prior to the beginning of fibrillogenesis. The fibrillogenesis is subsequently induced by increasing the temperature. The fibrils formed in situ can either remain as a collagen gel, or be dried analogously to the surface coating. [0040] The implant or scaffold prepared in this way can advantageously be sterilized using the known nonthermal methods such as ethylene oxide or gamma irradiation and stored at room temperature. [0041] The implant or scaffold coated according to the invention with an osteogenic matrix composite is delineated by the following advantages from the solutions known from the prior art: Good biological compatibility and functionality of the matrix produced by means of largely physiological composition and structure on account of the conditions in the production and use of components which correspond to those of the natural cell environment High variability with respect to employable components and their proportions in the component mixture Easy storage and sterilization conditions High specificity and efficiency due to the utilization of endogenous osteogenic factors. BRIEF DESCRIPTION OF THE DRAWINGS [0046] The invention is illustrated in more detail by means of the following working examples, comparative tests and figures. [0047] The figures show [0048] FIG. 1 Influence of decorin and chondroitin sulfate, (CS) on the formation of collagen fibrils, measured as the increase in the turbidity of a fibrillogenesis solution in OD over time [0049] FIG. 2 AFM photographs of the fibril structure [0050] FIG. 3 Chondroitin sulfate and, decorin present in osteogenic matrix composites according to the invention [0051] FIG. 4 Binding behavior of osteogenic matrix composites according to the invention for the recombinant growth factors BMP-4 and TGF-1β [0052] FIG. 5 Behavior of primary rat calvaria osteoblasts on various osteogenic matrix composites according to the invention influence on adhesion and osteopontin expression [0053] FIG. 6 Activity of alkaline phosphatase in rat calvaria cells on various osteogenic matrix composites according to the invention after addition of 4 pmol/cm 2 of BMP-4 [0054] FIG. 7 New bone formation on the implant surface in percent after 6 months in minipig jaw DETAILED DESCRIPTION OF THE INVENTION WORKING EXAMPLE 1 Fibril Structure after Fibrillogenesis under Various Conditions [0055] For the generation of the osteogenic matrix composite, a solution of collagen monomers in 0.01 M acetic acid is prepared by stirring for 24 hours at 4° C. The collagen fibrils are subsequently formed in the presence of the noncollagenic components by a process of self-aggregation (fibrillogenesis) in aqueous phosphate buffer solutions at neutral pH and a temperature of 37° C. [0056] The range for the formation of the fibrils is between 0.5 and 5 mg of collagen/ml and 0.1 to 5 mg of glycosaminoglycan/ml, 1 mg/ml of collagen and 0.2 mg/ml of GAG and 30 μg/ml of proteoglycan being the preferred conditions. The preferred fibrillogenesis parameters were a 30 mmol/l phosphate buffer pH 7.0, either with 135 mmol/l of NaCl or without NaCl addition. [0057] Glycosaminoglycans or other matrix components are added to the collagen monomers before fibrillogenesis and thereby integrated at least partially into the resulting fibrils in the following process of fibrillogenesis. [0058] FIG. 1 shows, in a measurement of the turbidity of a solution caused by fibril formation, over time, that increasing amounts of decorin (indicated in molar ratios) cause a slowing of the formation kinetics and a reduction of the maximum OD values, indicative of a reduction of the fibril diameter. For chondroitin sulfate, an opposite effect is to be observed. Formation conditions: 250 μg/ml of collagen, 37° C., 30 mmol/l of phosphate buffer pH 7.4 containing 135 mmol/l of NaCl. [0059] In FIG. 2 , the influence of the formation conditions on the structure of the resulting fibrils is documented in AFM photographs. Addition of decorin reduces the fibril diameter (a and d) under all conditions. For chondroitin sulfate, in particular under conditions of low ionic strength, a markedly more heterogeneous distribution of the fibril diameter is visible with increase in the average fibril diameter (f), while the effect is not apparent at higher ionic strengths (c). b and e show the fibril structure without noncollagenic additives. Formation conditions: 250 μg/ml of collagen, 37° C., 30 mmol./l of phosphate buffer pH 7.4 (buffer A) or 30 mmol/l of phosphate buffer pH 7.4 containing 135 mmol/l of NaCl (buffer B). [0060] In all cases, however, during fibrillogenesis in vitro the collagen monomers form the characteristic transversely striated fibrils analogously to the in vivo structures, the structure of the resulting fibrils being influenced both by the process parameters (pH, ionic strength, phosphate concentration) and by the nature and amount of the added noncollagenic components. Collagen fibrils containing noncollagenic constituents such as glycosaminoglycans or decorin can accordingly be produced in a comparatively wide range of mass ratios, within which the integration of the collagen into the fibrils is not or is only slightly influenced. WORKING EXAMPLE 2 Incorporation of Noncollagenic Components into Collagen Fibrils [0061] For generation of the osteogenic matrix composite, a solution of collagen monomers in 0.01 M acetic acid is prepared by stirring at 4° C. for 24 hours. The collagen fibrils are subsequently formed by a process of self-aggregation (fibrillogenesis) in aqueous phosphate buffer solutions at neutral pH in the presence of the noncollagenic components. Formation conditions: 250 μg/ml of collagen, 37° C., 30 mmol/l of phosphate buffer pH 7.4 (buffer A) or 30 mmol/l of phosphate buffer pH 7.4 containing 135 mmol/l of NaCl (buffer B) with different chondroitin sulfate and decorin concentrations. [0062] After washing and hydrolysis of the fibrils in 500 μl of 6 M HCl at 105° C. for 6 hours, decorin and chondroitin sulfate integrated into the fibrils was determined according to the method of Pieper et al. [Pieper J S, Hafmans T, Veerkamp J H, van Kuppevelt T H. Development of tailor-made collagen-glycosaminoglycan matrices: EDC/NHS crosslinking, and ultrastructural aspects. Biomaterials 2000; 21(6): 581-593]. [0063] For chondroitin sulfate, the extent of the integration is dependent on the ionic strength of the buffer system. used. For low ionic strengths (buffer A), of the 20 μg employed, about 2.5 μg of CS are incorporated on 250 μg of collagen, for high ionic strengths (buffer B), however, only a third of this amount ( FIG. 3 ). [0064] The incorporation of decorin also depends on the buffer system used. For buffer A, a third of the amount employed is incorporated, while the values for buffer B were again markedly lower. WORKING EXAMPLE 3 Recruitment of Growth Factors by an Implant Coated with an Osteogenic Matrix Composite [0065] Matrices composed and produced according to the invention can accelerate and improve bone formation and accumulation without the use of recombinant growth factors by the recruitment of endogenous growth factors. In the experiment, such a binding behavior can only be demonstrated using recombinant growth factors. [0066] A sandblasted, cylindrical sample of TiAl6V4 having a diameter of 10 mm is cleaned with ethanol, acetone and water. [0067] A solution of 1 mg/ml of bovine collagen type I in 0.01 M acetic acid is produced by stirring overnight at 4° C. Noncollagenic ECM components (glycosaminoglycan 30 μg/ml, proteoglycans 15 μg/ml) are added to this solution. The mixtures are treated with fibrillogenesis buffer (60 mmol/l of phosphate, 270 mmol/l of NaCl, pH 7.4) on ice and incubated at 37° C. for 18 h. The resulting fibrils are centrifuged off, washed, homogenized and resuspended to give a final concentration of 1 mg/ml. [0068] The cylindrical sample is coated (dip-coating) with this solution at RT for 15 min, washed with water and dried. [0069] Subsequently, growth factors (recombinant BMP-4 or TGF-1β) are immobilized on these -surfaces by an adsorption process (4° C., 18 h, from PBS) and subsequently. determined by means of ELISA. [0070] These in vitro tests with recombinant growth factors show that by the addition according to the invention of noncollagenic components, the binding of the growth factors rhBMP-4 (in particular by addition of chondroitin sulfate) or rhTGF-1β (in particular by addition of decorin) to the matrix is increased. For BMP, with small amounts (2-20 ng/cm 2 ) no effect is observed, with higher amounts (from 50 ng/cm 2 ), however, an approximately 10% higher binding to the chondroitin sulfate-containing layer occurs, compared with the pure collagen layer, shown in % of the amount employed ( FIG. 4 ). [0071] For rhTGF-1β, increased binding is detectable on decorin-containing surfaces both for 1 ng/cm 2 and for 10 ng/cm 2 . [0072] Formation conditions of the matrix: 500 μg/ml of collagen, 30 μg/ml of decorin and/or chondroitin sulfate, 37° C., 30 mmol/l of phosphate buffer pH 7.4 containing 135 mmol/l of NaCl. WORKING EXAMPLE 4 Investigations with Rat Calvaria Osteoblasts on Various Matrix Composites [0073] FIG. 5 shows the behavior of primary rat calvaria osteoblasts on various matrices. Initial adhesion of the cells to different matrix compositions was analyzed by means of cell morphology, cytoskeletal organization (actin staining with phalloidin) and formation of the focal adhesion complexes by means of integrin receptors (immunostaining against vinculin). Adhesion was most pronounced after 2 hours on collagen-CS matrices followed by collagen-decorin. The formation of the FACS (green-yellow dots and red on the ends of the actin fibrils) was also promoted and accelerated by decorin and particularly CS. Controls using pure collagen matrices showed significantly less FACS after 2 hours. [0074] The influence of the matrix composition on the differentiation of the osteoblasts was investigated by means of the expression of the marker protein osteopontin by means of fluorescence-activated cell scanning. Osteoblasts on collagen-CS surfaces produced 5 times more osteopontin (˜2500 fluorescence units) after 8 days than cells on pure collagen surfaces (−500 fluorescence units). Formation conditions of the matrix: 500 μg/ml of collagen, 30 μg/ml of decorin and/or chondroitin sulfate, 37° C., 30 mmol/l of phosphate buffer pH 7.4 containing 135 mmol/l of NaCl. [0075] Further investigations with rat calvaria osteoblasts showed different cell reactions on rhBMP-4 depending on the composition of the carrier matrix. FIG. 6 shows the activity of the alkaline phosphatase in activity units U per mg of protein after addition of 4 pmol/cm 2 of rhBMP-4 to rat calvaria cells. On decorin-containing matrices, the BMP activity is underregulated, while on chondroitin sulfate-containing matrices it is increased. Formation conditions of the matrix: 500 μg/ml of collagen, 30 μg/ml of decorin and/or chondroitin sulfate, 37° C., 30 mmol/l of phosphate buffer pH 7.4 containing 135 mmol/l of NaCl. WORKING EXAMPLE 5 Animal Experiments [0076] In animal experiments, it was surprisingly found that matrices provided with recombinant growth factors perform markedly more poorly with respect to induced bone formation than the noncrosslinked osteogenic matrix composites according to the invention based on collagen type I and chondroitin sulfate. [0077] Ti implants, which have annular incisions at right angles to the axis and thus represent a defect model, are cleaned with 1% Triton X-100, acetone and 96% ethanol, rinsed with distilled water and dried. [0078] The implants employed are coated in two successive dip-coating steps with: A. fibrils of collagen type I, B. osteogenic matrix composite according to the invention based on collagen type I and chondroitin sulfate according to working example 1 C. osteogenic matrix composite according to the invention based on. collagen type I and chondroitin sulfate according to working example 1 [0082] The implants are washed with distilled water, air-dried and sterilized with ethylene oxide at 42° C. for 12 h. Immediately before implantation, the surface condition C is coated overnight with recombinant BMP-4 (400 ng/ml) at 4° C. and subsequently dried. [0083] The implants are employed in the lower jaw of minipigs. The bone implant contact was determined histomorphometrically after 6 months. [0084] The highest percentage for this contact is obtained for implants coated with the osteogenic matrix according to the invention based on collagen and chondroitin sulfate (27.8%), while implants with the same coating and recombinant BMP-4 and the combination were around 15% and thus markedly lower. The lowest values are obtained for the pure collagen coating (12.8%) ( FIG. 7 ). [0085] The following abbreviations are used in the description of the invention: bFGF Basic fibroblast growth factor BMP Bone morphogenetic protein ECM Extracellular matrix EGF Endothelial growth factor FACITs Fibril associated collagen with interrupted triple helix FACS Focal adhesion contacts FGF Fibroblast growth factor GAG Glycosaminoglycan HAP Hydroxylapatite IGF-I Insuline-like growth factor PGA Polyglycolic acid PLA Polylactic acid SLRP Small leucine-rich protein TCP Tricalcium phosphate phases TES (N-[Tris(hydroxymethyl)methyl]-2-aminoethanesulfonic acid) TGF-β Transforming growth factor β VEGF Vascular endothelial growth factor WF Growth factor

1a

This is a continuation, of application Ser. No. 962,435, filed Nov. 20, 1978, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to compositions of poorly soluble or water soluble drugs which provide poor bioavailability or are irregularly absorbed following oral administration of their solid dosage forms. More specifically, the herein disclosed invention relates to new compositions of matter containing poorly soluble or water insoluble drugs, a nontoxic water soluble polymer and a wetting agent. The invention further relates to a process for preparing and a method for using the disclosed compositions which compositions provide a high order of drug bioavailability. In the main, the invention will be illustrated with the known antifungal griseofulvin. 2. Description of the Prior Art Many drugs give an incomplete and irregular absorption when taken orally, particularly poorly water soluble or water insoluble compounds such as griseofulvin and many steroids. One of the earlier attempts to enhance the availability or bioavailability of such drugs relied on mechanical micronization of the pure compounds in order to decrease their particle size. While micronization did enhance absorption over the use of unmicronized material, absorption of the drug was still incomplete. Further the degree of micronization which can be achieved is limited and the micronized particles tend to agglomerate, thus diminishing both the solubility of the drug and its bioavailability. U.S. Pat. No. 2,900,304 is an illustration of griseofulvin compositions for oral or parenteral administration employing micronized drug particles. Another approach for attempting to enhance the bioavailability of griseofulvin was studied by Marvel et al and reported in The J'l of Investigative Dermatology, 42, 197-203 (1964). Their studies related to the effect of a surfactant and particle size on the bioavailability of griseofulvin when orally administered. Results of their studies indicated that bioavailability of the drug was enhanced when administered in very dilute solutions or aqueous suspensions. Their results further tended to confirm that enhanced bioavailability was obtained with griseofulvin having a higher specific surface area, at least when administered in full daily divided doses. With respect to the effect of the surfactant sodium lauryl sulfate incorporated into grisefulvin tablets, their results demonstrated some initial enhancement of bioavailability with regularly particle sized drug and very little enhancement with micronized drug in comparison to surfactant-free tablets. These investigators further reported that when the daily dose was divided, the surfactant had no enhancing effect. Still another approach for the enhancement of drug bioavailability is represented by the work of Tachibana and Nakamura in Kollid-Zeitschrift and Zeitschrift Fur Polymere, 203, pgs. 130-133 (1965) and Mayershohn et al in the Journal of Pharmaceutical Science, 55, pgs. 1323-4 (1966). Both publications deal with the use of polyvinylpyrrolidone (PVP) for forming dispersions of a drug. Tachibana discusses the role of PVP in forming very dilute colloidal dispersions of β-carotene in PVP. Mayersohn further prepared solid dispersions or solid solutions of griseofulvin in PVP and the reported results show dissolution rates for the drug increasing with increasing proportions of PVP. This last publication further reported that in the absence of wetting agent in the dissolution medium, the enhancement of the dissolution rate is still greater. Canadian Pat. No. 987,588 of Riegelman et al, similarly discloses the use and process for making solid dispersions of a drug for enhancing its dissolution rate and bioabailability. In this case the solvents employed were polyethylene glycol (PEG) having molecular weights ranging from 4,000 to 20,000, pentaerythritol, pentaerythritol tetraacetate and monohydrous citric acid. Riegelman postulated that these solvents provided a matrice for griseofulvin which retards crystallization during the solidification process resulting in an ultramicrocrystalline form of the drug with correspondingly faster dissolution. Riegelman's results tend to support this finding of faster dissolution rates for solid solutions of griseofulvin over those of unmicronized, non-wetted micronized and wetted micronized griseofulvin. But his findings were limited to those solid solutions which contain less than 50 percent by weight of the drug since the results demonstrated a slowing of the dissolution rate with higher concentrations of griseofulvin. Riegelman further concluded that the rate of dissolution for a composition having the same ratio of drug to solvent varies significantly depending on the method of preparation, with melt mixing at elevated temperatures in a volatile solvent providing the preferred mode or process. Another process for preparing ultramicrocrystalline drug particles to increase dissolution of a drug is disclosed by Melliger in Belgian Pat. No. 772,594. That process is characterized by preparing a solution of the drug, PVP and urethane and subsequently removing the urethane. It was reported that, in general, satisfactory results were obtained using solutions in which the quantity of drug represented up to 50 percent by weight of the quantity of PVP present. U.S. Pat. Nos. 3,673,163 and 4,024,240 respectively are further illustrations relating to the use of PVP in solid dispersions. In the first-cited patent, coprecipitates of acronycine with polyvinylpyrrolidone were prepared in proportions weighted to the polymer to increase the solubility of the coprecipitated acronycine. In the second-cited patent solid antibiotic dispersions containing the antibiotic designated A-32390, in proportions again weighted toward the PVP co-dispersant, were disclosed. Further examples of antibiotic combinations containing PVP are disclosed in U.S. Pat. No. 3,577,514 wherein the PVP is used as a binding agent; and in U.S. Pat. Nos. 3,485,914 and 3,499,959, wherein the PVP is used to sustain the release of the antibiotic. PVP has also been used as a stabilizer with nitroglycerin to retard migration between nitroglycerin tablets as disclosed in U.S. Pat. No. 4,091,091. With respect to processes employed in preparing certain PVP-griseofulvin compositions, Junginger in Pharm. Ind. 39, Nr. 4 at pgs. 384-388 and Nr. 5 at pgs. 498-501 (1977), reported that spray-dried products provided systems with higher energy levels in comparison with those of simple mixtures and coprecipitates, and correspondingly greater dissolution rates. Junginger further disclosed that the dissolution rates of the simple mixtures were higher when the PVP contents were increased. In a further attempt to increase the bioavailability of griseofulvin, the drug was treated with small amounts of hydroxypropyl cellulose and formulated into capsules, see Fell et al, J. Pharm. Pharmac., 30, 479-482 (1978). While the formulation produced by this treatment increases the rate and extent of availability of micronized griseofulvin, and authors reported that the treated formulation does not always lead to complete absorption from the upper intenstine as was reported for the Riegelman solid disperse system with polyethylene glycol 6000. SUMMARY OF THE INVENTION This invention provides compositions of poorly soluble or water insoluble drugs which provide higher dissolution rates in vitro and increased bioavailability of said drugs in vivo. The composition of this invention comprises a mixture or solution of the drug with a non-toxic, pharmacologically acceptable water soluble polymer wherein said mixture or solution has been treated with a minor amount of a wetting agent selected from anionic and cationic surfactants. The term mixture means the product of a melt mix or that of a dried solution. Examples of suitable polymers are those selected from at least one of the group comprising polyvinylpyrrolidone, hydroxypropylmethyl cellulose, hydroxypropyl cellulose, methyl cellulose, block copolymers of ethylene oxide and propylene oxide, and polyethylene glycol. Suitable surfactants include those of the anionic variety such as sodium lauryl sulfate, sodium laurate or dioctylsodium sulphosuccinate, and those of the cationic variety such as benzalkonium chloride, bis-2-hydroxyethyl oleyl amine or the like. In another embodiment, the invention includes a method for treating mammals with said drugs by increasing the bioavailability of the drug following its administration using the composition of this invention. Still a further embodiment of this invention is a method of preparing compositions with increased bioavailability in mammals from a poorly soluble or water insoluble drug. The method includes the steps of: (a) Forming a mixture or solution of a drug with a non-toxic, pharmacologically acceptable water-soluble polymer; (b) drying the drug-polymer solution; (c) mixing the dried drug-polymer mixture or solution with a surface wetting amount of wetting agent solution wherein said agent is selected from anionic and cationic surfactants; and (d) drying the mixture of step (c). The method for preparing these compositions is also useful as a method for preparing ultramicrocrystalline griseofulvin. While the invention is illustrated with poorly soluble or water soluble drugs, and particularly grisefulvin, it will become apparent to those skilled in the art that the compositions and method of this invention are also suitable for other drugs which while relatively soluble have a tendency to agglomerate or crystallize in storage, or after formulation into pharmaceutical dosage forms. DETAILED DESCRIPTION OF THE INVENTION This invention relates to compositions of a drug with a water soluble polymer which has been treated with a wetting sufficient amount of a wetting agent selected from anionic and cationic surfactants. In preferred embodiments the composition is a solid, usually a powder, which is then compounded into suitable solid dosage forms for oral administration. Griseofulvin is a known antibiotic which has been found useful in the treatment of certain fungus diseases of plants, man and animals. Griseofulvin as discussed in the background of this invention is also known as a poorly soluble or water soluble drug, which in vivo provides a low order of bioavailability when administered orally. Thus the composition of the instant invention is particularly useful for griseofulvin and drugs of a similar nature such as certain steroids and antibiotics which due to their low aqueous solubility and/or high melting point are poorly absorbed. Illustrative of such drugs are medrogestone; progesterone; estradiol; 10,11-dihydro-5H-dibenzo[a,d]cycloheptene-5-carboxamide; 5H-dibenzo[a,d]cycloheptene-5-carboxamide and the like. The compositions of this invention, as will soon be appreciated, further permit the formulation of solid dosage forms which may contain high concentrations of the particular drug, such as griseofulvin, with no concomitant loss of bioavailability usually associated with such high concentrations. These compositions thus allow the preparation of elegant solid dosage forms. The compositions of this invention are also resistant to agglomeration of the drug particles or the tendency of the drug in storage to produce undesirable crystal formation which adversely affects bioavailability of the drug. Polymers useful in this invention include water soluble polymers which are nontoxic and pharmacologically acceptable, particularly for oral administration. Illustrative of polymers, found suitable in this invention include polyvinylpyrrolidone, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, block co-polymers of ethylene oxide and propylene oxide, and polyethylene glycol. Generally these polymers are commercially available over a broad range of average molecular weights. For example, polyvinylpyrrolidone (PVP) is a well known product produced commercially as a series of products having mean molecular weights ranging from about 10,000 to 700,000. Prepared by Reppe's process: 1,4-butanediol obtained in the Reppe butadiene synthesis is dehydrogenated over copper at 200° forming γ-butyrolactone; reaction with ammonia yields pyrrolidone. Subsequent treatment with acetylene gives the vinyl pyrrolidone monomer. Polymerization is carried out by heating in the presence of H 2 O 2 and NH 3 . DeBell et al., German Plastics Practice (Springfield, 1946); Hecth, Weese, Munch. Med. Wochenschr. 1 943, 11; Weese, Naturforschung & Medizin 62, 224 (Wiesbaden 1948), and the corresp vol. of FIAT Review of German Science. Monographs: General Aniline and Film Corp., PVP (New York, 1951); W. Reppe, Polyvinylpyrrolidon (Monographie zu "Angewandte Chemie" no. 66, Weinheim/Bergstr., 1954). Generally available commercial grades have average molecular weights in the range of 10,000 to 360,000, for example, General Aniline and Film Corporation (GAF) markets at least four viscosity grades available as K-15, K-30, K-60, and K-90 which have average molecular weights of about 10,000, 40,000, 160,000 and 360,000, respectively. The K- values are derived from viscosity measurements and calculated according to Fikentscher's formula (Kline, G. M., Modern Plastics 137 No. 1945). Similar commercial products are available from BASF-Wyandotte. Selection of a particular polymer with its characteristic molecular weight will in part depend on its ability to form suitable dosage forms with the particular drug. Thus, in preparing solid dosages, whether in powder, tablet or capsule units, the composition of this invention should be readily grindable or pulverizable, or in the form of free-flowing powders. A second consideration in the selection of a particular polymer derives from the limitations inherent in the use of specific equipment with polymers of increasingly higher viscosity. For example in forming the drug-polymer solution or mixture, complete dissolution or mixing could be inhibited utilizing blenders, mixer or the like, which are inadequate by reason of low shear or proper baffles to form a uniform and homogeneous drug-polymer solution or mixture. Depending on the process employed for forming of the drug-polymer mixture, another consideration in the selection of a particular polymer is that the polymer be mutually soluble in solvents for the particular drug. The wetting agents found most suitable for the present invention are those selected from anionic or cationic surfactants. In addition, to those cited in the summary of this disclosure, other suitable surfactants of the anionic variety are illustrated by sodium stearate, potassium stearate, sodium oleate and the like. The compositions of this invention are prepared in a step by step process. In the first step, a mixture or solution of the drug witht the water soluble polymer is formed. The mixture can be formed in a solvent or solvent mixture which is a mutual solvent for both the drug and the polymer. Alternatively, the drug-polymer, solvent mixture can, at this stage, be coated onto lactose. Where the drug and the polymer are not subject to degradation at elevated temperatures, the drug-polymer mixture may also be formed by melt mixing. Any volatile solvent in which the drug is soluble is suitable for forming the drug-polymer mixture. For griseofulvin, suitable solvents would include methylene chloride, methylene chloride-ethanol, chloroform, acetone, methyl ethyl ketone and combinations thereof. The most suitable polymer for forming the melt mixture with a drug such as griseofulvin is hydroxypropyl cellulose. After the drug-polymer mixture or solution has been formed in a solvent it is dried by spray-drying, flash evaporation or air drying. Commercially, spray-drying is most practical since the dried mixture is already in powder form. In the case of the melt mixture drying the drug-polymer mixture is defined as cooling. The melt-mix product is then ground or milled into powder form in preparation for the next step; grinding or milling may also be necessary for dried solvent formed mixtures. The powdered drug-polymer mixture is then treated with a wetting sufficient amount of a primarily aqueous wetting solution containing a wetting agent selected from anionic and cationic surfactants. This wetting treatment is accomplished by forming a slurry, wet granulation or paste mixture of the powdered drug-polymer with the wetting solution. The wetting solution treatment can be achieved with small incremental additions of the wetting solution or a larger single-shot treatment. The wetting solution treatment apparently fulfills two roles: crystallization of any amorphous regions into ultramicrosize crystals, and the breakup of clusters of such crystals so that they disperse spontaneously when exposed to water. Also, the role of the primarily aqueous solution for the wetting agent treatment is to distribute the wetting agent to surfaces of the drug, whether or not the drug is amorphous or crystalline. When the employment of more than one polymer is desired, separate drug-polymer mixtures for each polymer are usually prepared which are then initimately blended with each either in dry form prior to or after the wetting solution treatment. The treated mixture is then dried as earlier described and, if necessary, it is milled, screened or ground prior to formulating into suitable dosage forms with pharmaceutically acceptable excipients. It will be again appreciated by those skilled in the art that while the invention is illustrated with particularly water insoluble drugs, the composition and method of this invention is also applicable to more soluble drugs in need of enhanced bioavailability. In such instances a broader range of solvents and polymers including the natural gums may be employed to form the drug-polymer mixture. The concentrations of drug found useful in the drug-polymer mixture of this invention range from the lowest therapeutically effective amount of the drug up to about 90 to 95% of the drug. Thus, in griseofulvin-polymer mixtures, the concentration of griseofulvin ranges from about 0.1% by weight to about 90-95% by weight. In order to form pharmaceutically elegant dosage forms for high dose drugs, the concentration of the drug should be at least 50% by weight of the drug-polymer mixture. In especially preferred embodiments the concentration of drug in the drug polymer mixture will range from about 50% to about 80% by weight. The required concentration for the wetting agent (or surfactant) in the primarily aqueous wetting solution is a wetting sufficient amount. This amount further depends on whether incremental or single-shot wetting treatments are employed and on whether a slurry or paste treatment is contemplated. Generally, small incremental treatments will require less wetting agent than a larger single shot treatment and a paste treatment will require more wetting agent than a slurry. In any case, it has been found that satisfactory results are obtained when the amount of wetting agent comprises from about 0.025% to about 2.0% by weight of the dried drug polymer mixture and preferrably from about 0.1% or 0.2% to about 1.0% by weight. While higher concentrations of the wetting agent may be satisfactorily employed, no additional advantages in terms of dissolution and/or bioavailability are obtained. It has also been found that when a griseofulvin-polymer, melt mixture has been wetted and crystallized from an aqueous sorbitol solution, enhanced dissolution rates was obtained, however the rate of dissolution was still less that those mixtures treated with a wetting agent. The invention is further illustrated by the following examples. EXAMPLE 1 The rate of dissolution of the powdered materials was determined by one of three methods. All three methods gave equivalent results and only the results of method 1 outlined below are used herein unless otherwised noted. Method (1) A sample containing 20 mg of griseofulvin was dissolved into 1 liter of a 0.02% polysorbate 80 aqueous solution at 37° C. The solution was monitored by a flow cell in a spectrophotometer set at 295 nm. Method (2) A sample containing 500 mg griseofulvin was dissolved in 10 liters of 0.15% sodium lauryl sulfate in water at 37° C. Method (3) A sample containing 125 mg griseofulvin was dissolved in 24 liters of water at 37° C. For examples 2-5 the wetting agent solution employed was as follows: 2.5 g of sodium lauryl sulfate (SLS) were dissolved into 500 ml of a mixture of 100 ml of water and 400 ml of ethyl alcohol or 0.25 g of sodium lauryl sulfate were dissolved into 50 ml of a mixture of 10 ml of water and 40 ml of ethyl alcohol. EXAMPLE 2 This example describes the preparation of ultramicrocrystalline griseofulvin. The method consists of flash evaporation of a solution containing 10 g of griseofulvin and 10 g of polyvinylpyrrolidone (POVIDONE® K-30, U.S.P.-from GAF Corp.) dissolved in 200 ml of methylene chloride. The evaporation was done on a rotating evaporator at 35°-45° C. in a closed system (Vacuum). About 4-5 ml of the solution to be evaporated was placed in a 100 ml round bottom flask, then placed on the evaporator. Upon evaporation of solvent, the material was deposited onto the wall of the flask. The dried material was found to be amorphous by X-ray diffraction. Next, this amorphous material was treated with the SLS solution. To 2 g of powder, 0.125 ml of the solution was added with constant mixing and the solvent was allowed to dry. This was repeated six more times until a total of 0.875 ml of solution had been added. Microscopic observation and dissolution data showed that ultramicrocrystalline griseofulvin was formed by this method and has a much faster dissolution rate into water at 37° C., than microsized griseofulvin or untreated amorphous material TABLE 1______________________________________ Dissolution profile of griseofulvin into water at 37° C. Thedissolved griseofulvin, unless otherwise specified, is expressedin mg/liter over an elapsed time period in minutes.Sample 1 min. 2 min. 3 min. 5 min. 10 min. 14 min.______________________________________1 11.2 11.7 11.9 12.0 12.2 12.52 2.5 3.8 4.8 6.5 8.7 9.83 1.6 2.7 3.4 4.7 7.0 8.2______________________________________ 1-Flash evaporated griseofulvin: PVP (50% griseofulvin) treated with SLS solution. 2Flash evaporated griseofulvin: PVP(50% 3-Microsized griseofulvin EXAMPLE 3 Table 1--This example describes the preparation of ultramicrocrystalline griseofulvin by coating a solution of griseofulvin and polyvinylpyrrolidone onto lactose then treating the powder with a solution of sodium lauryl sulfate. A solution was prepared by dissolving 1 g of griseofulvin and 1 g of polyvinylpyrrolidone into 8 ml of methylene chloride. All this solution was coated successively in 1 ml portions onto 2 g of lactose and allowed to dry. The material formed by this method was crystalline by X-ray diffraction. Next 1 ml of the SLS solution was added to the 4 g of powder and allowed to dry. Microscopic observation and dissolution data showed that the griseofulvin formed by this method was ultramicrocrystalline and had a much faster dissolution rate into water at 37° C., than microsized griseofulvin. TABLE 2______________________________________Sample 1 min. 2 min. 3 min. 5 min. 10 min. 14 min.______________________________________1 10.8 11.6 11.8 11.9 12.0 12.02 7.0 8.7 9.7 10.5 11.5 11.53 1.6 2.7 3.4 4.7 7.0 8.2______________________________________ 1-griseofulvin: PVP (50:50) coated onto lactose and treated with SLS solution. 2griseofulvin: PVP (50:50) coated onto lactose. 3Microsized griseofulvin EXAMPLE 4 This example describes the preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyvinylpyrrolidone then treating with powder with a solution of sodium lauryl sulfate. A solution of 50 g of griseofulvin and 50 g of polyvinylpyrrolidone dissolved in 2 liters of methylene chloride was spray dried at room temperature. A mixture of 1 ml of the SLS solution and 2 g of the powder was dried. Microscopic observation and dissolution data showed the griseofulvin formed by this method to be ultramicrocrystalline and has a much faster dissolution rate into water at 37° C. than microsized griseofulvin. TABLE 3______________________________________Sample 1 min. 2 min. 3 min. 5 min. 10 min. 14 min.______________________________________1 10.5 10.7 10.8 11.0 11.0 11.02 3.2 4.4 5.6 8.1 9.9 10.43 1.6 2.7 3.4 4.7 7.0 8.2______________________________________ 1-Spray dried griseofulvin: PVP (1:1) treated with SLS solution. 2Spray dried griseofulvin: PVP(1:1) 3-Microsized griseofulvin EXAMPLE 5 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyvinylpyrrolidone and then treating the powder with a solution of sodium lauryl sulfate. A solution containing 70 g of griseofulvin and 30 g of polyvinylpyrrolidone dissolved into 2 liters of methylene chloride was spray dried at room temperature. To 2 g of the powder, 3/4 ml of the SLS solution was added in six 0.125 ml increments and dried between additions. Microscopic observation and dissolution data showed that the griseofulvin formed by this method was ultramicrocrystalline and had a much faster dissolution rate into water at 37° C. than microsized griseofulvin. TABLE 4______________________________________Sam-ple 1 min. 2 min. 3 min. 5 min. 10 min. 14 min. 15 min.______________________________________1 10.0 10.9 11.5 12.0 12.5 12.7 --2 2.5 3.9 4.9 6.5 9.0 10.4 --3 1.6 2.7 3.4 4.7 7.0 8.2 --4 1.9 3.5 4.6 6.3 8.6 -- 9.75 1.8 3.0 4.0 5.8 8.1 -- 9.36 1.9 3.1 4.3 6.0 8.6 -- 9.7______________________________________ 1-Spray dried griseofulvin: PVP(70:30) treated with SLS solution. 2Spray dried griseofulvin: PVP(70:30). 3Microsized griseofulvin 4-Spray-dried griseofulvin: PVP treated with the nonionic polysorbate 80. griseofulvin: PVP: nonionic(69.7:29.7:0.5) 5Spray dried griseofulvin: PVP treated with the nonionic block copolymer of ethylene oxide and propylene oxide (Pluronic® F77) griseofulvin:PVP: nonionic (69.7:29.7:0.5) 6Spray dried griseofulvin: PVP treated with the nonionic isooctyl phenoxy polyethoxy ethanol.griseofulvin PVP: nonionic (69.7:29.7:0.5) TABLE 5______________________________________Dissolution ProfileSample 1 min. 2 min. 3 min. 5 min. 10 min. 14 min.______________________________________1 10.0 10.9 11.5 12.0 12.5 12.72 6.9 8.7 9.7 10.4 11.3 --3 6.0 7.0 7.3 7.7 8.0 --4 1.6 2.7 3.4 4.7 7.0 8.2______________________________________ 1-Spray dried griseofulvin: PVP(70:30) treated 2-Dorsey Laboratories' GrisPeg (Trademark) for griseofulvin composition i PEG 6000. 3Schering Laboratories' Fulvicin P/G (Trademark) for griseofulvin composition in PEG 6000. 4Microsized griseofulvin. EXAMPLE 6 In the samples evaluated in Tables 6-8, the following further describes their preparation. MATERIALS & METHODS Two grades of hydroxypropyl cellulose were used, Klucel® EF and Klucel® LF (Hercules), the former preferred for its lower viscosity. Coarse griseofulvin, spray dried lactose, sorbitol, and sodium lauryl sulfate were the other ingredients. The solvents were methylene chloride and absolute ethanol, U.S.P. grade. Crystallinity of griseofulvin preparations were judged by visual microscopic observation under crossed polarizers, or by X-ray diffraction assay. Preparation of a Melt Mixture A glass melting tube immersed in a hot oil bath was used to melt together various amounts of griseofulvin and Klucel. After complete melting and mixing, the liquid mixture was rapidly chilled under a cold water tap, while rotating the tube horizontally so as to distribute the liquid over the inside walls. After solidification, the tube was further cooled in a dry ice bath, which fractured the product and allowed its removal from the glass tube. The chunky product was ground to a powder in a micromill. Crystallization with a Sorbitol Solution Typically, an amount of powdered melt mixture was intimately mixed with an equal weight of an aqueous solution containing, by weight, about 22% sorbitol and 13% ethanol. This was vigorously mixed and worked with a spatula, until the doughy mixture acquired the consistency of a smooth cream or paste. The paste was allowed to dry, and the dry chunky product was ground in a mortar. Spray Dried Mixtures Solution for spray drying were prepared by dissolving griseofulvin and Klucel in a mixture of methylene chloride and ethanol. An Anhydro Laboratory Spray Dryer No. 3 was used, and the solution was spray dried at room temperature. Crystallization with a Sodium Lauryl Sulfate Solution Typically, a weight of spray dried powder (whether amorphous or crystalline) was intimately mixed with about 0.9 weight of a 1.5% aqueous solution of sodium lauryl sulfate. The solution could also contain ethanol and sorbitol or lactose, but this was found to be unnecessary. The doughy mixture was vigorously mixed and worked with a spatula, until it became a smooth paste. Then, about 0.25 weight of lactose was added, and mixed until again smooth. The paste was spread and dried at around 85° C. The elevated temperature coagulated the wet paste into granules, which could be stirred and mixed at times during drying, to diminish caking. The dry product was milled and passed through a 60 or 80 mesh screen. The product contained about 1% sodium lauryl sulfate. Treatment of Spray Dried Mixtures with Sodium Lauryl Sulfate Solution, Without Pasting About 2.0 g of spray dried griseofulvin-Klucel® mixture was placed in a mortar, then treated successively with six 0.125 ml portions of a wetting solution, allowing enough drying between portions to prevent the powder from becoming pasty. The wetting solution contained 5 mg/ml sodium lauryl sulfate in a mixture of 4 parts ethanol -1 part water, by volume. The final granular powder contained about 0.2% sodium lauryl sulfate. Scale-up Attempts of Paste Treatment Crystallization of spray dried powders with sodium lauryl sulfate solution on a 1 kg scale were achieved in a Hobart mixer, equipped with a small bowl and a pastry blade. Lactose was added to the paste, then the mixture was spread on trays and dried at 85° C. The chunky, partially caked product was milled and screened. ______________________________________ Spray Dried Mixtures of Griseofulvin & Hydroxypropyl cellulose(Klucel)®Composition of SolutionSolids Griseofulvin SolventContent Content Volume(g/l of (% of Ratio Crystallinitysolvent) Solids) (MeCl.sub.2 /EtOH) of Product______________________________________100 50 7/1 Mostly amorphous 50 75 9/1 Amorphous167 75 8.6/1 Crystalline200 80 7/1 Crystalline______________________________________ TABLE 6______________________________________Dissolution profile.Sam-ple 1 min. 2 min. 3 min. 5 min. 10 min. 15 min. 20 min.______________________________________1 4.1 8.0 9.2 10.8 12.6 13.4 13.72 1.5 2.7 3.4 4.7 7.0 8.4 9.23 0.5 1.0 1.3 2.0 3.2 4.2 5.0______________________________________ 1-Melt mixture of griseofulvin (75%)Klucel® (25%), crystallized with sorbitol solution 2-Micronized griseofulvin 3-Melt mixture of griseofulvin (83%)Klucel® (17%), amorphous. TABLE 7______________________________________Sam-ple 1 min. 2 min. 3 min. 5 min. 10 min. 15 min. 20 min.______________________________________1 2.0 3.6 4.7 6.5 9.8 11.4 12.82 2.0 3.6 4.7 6.5 9.2 10.5 11.83 1.5 2.7 3.4 4.7 7.0 8.4 9.24 0.8 1.5 2.0 2.8 4.7 5.8 6.5______________________________________ 1-Spray dried griseofulvin (75%)Klucel® (25%) mixture, amorphous. 2-Spray dried griseofulvin (50%)Klucel® (50%) mixture, mostly amorphous. 3-Micronized griseofulvin. 4Spray dried griseofulvin (80%)Klucel® (20%) mixture crystalline. TABLE 8______________________________________Sam-ple 1 min. 2 min. 3 min. 5 min. 10 min. 15 min. 20 min.______________________________________1 6.2 11.1 11.5 12.0 12.5 12.7 12.82 6.2 10.2 11.0 11.6 12.1 12.2 12.33 1.5 2.7 3.4 4.7 7.0 8.4 9.2______________________________________ 1-Spray dried mixture of griseofulvin: PVP (70:30), treated with SLS solution./ 2 Spray dried mixture of griseofulvin: Klucel® (75:35), crystallized with sodium lauryl sulfate solution. 3Micronized griseofulvin EXAMPLE 7 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and hydroxypropyl methyl cellulose and then treating the powder with a solution of sodium lauryl sulfate. A solution containing 40 g of hydroxypropyl methylcellulose 80 g of griseofulvin and 200 ml of Methanol dissolved into 2 liters of methylene chloride was spray dried at R.T. The dried material was found to be amorphous by X-ray diffraction. To 4 g of the powder, 4 ml of a solution containing 1.5 g sodium lauryl sulfate dissolved into 100 ml of H 2 O was mixed in, and then dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method and has a much faster dissolution rate into water at 37° C., then microsized griseofulvin or untreated amorphous material. EXAMPLE 8 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and methylcellulose and then treating the powder with a solution of sodium lauryl sulfate. A solution containing 40 g of methylcellulose (15 cps) and 120 g of griseofulvin, and 200 ml of methanol dissolved into 2 liters of methylene chloride was spray dried at R.T. The dried material was found to be partly amorphous and partly crystalline by x-ray diffraction. To 4 g of the powder, 4 ml of a 1.5% sodium lauryl sulfate solution was added and mixed in. The mixture then was dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a much faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 9 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and poly(oxypropylene) poly(oxyethylene) block copolymer (Pluronic® F77 BASF Wyandotte Corp.) and then treating the powder with a solution of sodium lauryl sulfate. A solution containing 100 g of the block copolymer and 100 g griseofulvin dissolved into 2 liters of methylene chloride was spray dried at RT, to 4 g of the powder, 2 ml of a 1.5% sodium lauryl sulfate was added, mixed and then dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 10 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyethylene glycol and then treating the powder with a solution of sodium lauryl sulfate. A solution containing 100 g of griseofulvin and 100 g of polyethylene glycol 6000 dissolved into methylene chloride was spray dried. To 4 g of the powder, 2 ml of a 1.5% sodium lauryl sulfate solution was added, mixed and dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a much faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 11 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution containing griseofulvin and hydroxypropyl methylcellulose and then treating the powder with a solution of sodium lauryl sulfate. A solution containing 40 g of hydroxypropyl methylcellulose, 160 g of griseofulvin and 100 ml of ethanol dissolved into 2 liters of methylene chloride was spray dried. To 2 g of powder, 0.125 ml of sodium lauryl sulfate wetting solution (see above example No. 7) was added with constant mixing and the solvent was allowed to dry. This was repeated five more times until a total of 0.750 ml of solution had been added. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method and it has a much faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 12 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyvinylpyrrolidone and then treating the powder with a solution of benzalkonium chloride. A solution of 70 g of griseofulvin and 30 g of polyvinylpyrrolidone dissolved into 2 liters of methylene chloride was spray dried at RT. To 4 g of the powder, 2 ml of a 1% aqueous solution of benzalkonium chloride was added, mixed and then dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a much faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 13 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyvinylpyrrolidone and then treating the powder with a solution of sodium laurate. A solution of 70 g of griseofulvin and 30 g of polyvinylpyrrolidone dissolved into 2 liters of methylene chloride was spray dried at RT. To 4 g of the powder, 2 ml of a 2% aqueous solution of sodium laurate was added, mixed and then dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a much faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 14 This example describes preparation of ultramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyvinylpyrrolidone and then treating the powder with a solution of dioctyl sodium sulfosuccinate. A solution of 70 g of griseofulvin and 30 g of polyvinylpyrrolidone dissolved into 2 liters of methylene chloride was spray dried at RT. To 4 g of the powder, 2 ml of a 1% aqueous solution of dioctyl sodium sulfosuccinate was added, mixed and then dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a much faster dissolution rate then microsized griseofulvin or untreated material. EXAMPLE 15 This example describes preparation of ulramicrocrystalline griseofulvin by spray drying a solution of griseofulvin and polyvinylpyrrolidone and then treating the powder with a solution of bis(2-hydroxyethyl)oleylamine. A solution of 70 g of griseofulvin and 30 g of polyvinylpyrrolidone dissolved into 2 liters of methylene chloride was spray dried at RT. To 4 g of the powder, 2 ml of a 2% aqueous solution of bis(2-hydroxyethyl)oleylamine was added, mixed and then dried. Microscopic observation and dissolution data shows that ultramicrocrystalline griseofulvin was formed by this method, and it has a much faster dissolution rate then microsized griseofulvin or untreated material. TABLE 9__________________________________________________________________________The results of dissolution studies on the samples prepared by Examples7-15are listed below. The unit of expression for this Table is percent ofsaturation achievedin time expressed in minutes. wt. % Wet- Gris- Poly- ting eoful- Percent of Saturation - time Min.Polymer Wetting agent mer Agent vin 1 2 3 4 5 10 15 20 25__________________________________________________________________________None-Griseoful- None None None 100% 14.8 22.3 30.3 36.8 42.6 64.5 76.1 83.1 86.5vin MicrosizedPolyvinyl- Sodium Lauryl 49.9 0.2 49.9 92.9 99.2 100.6 101.3 101.9pyrrolidone SulfatePolyvinyl- Sodium Lauryl 29.9 0.2 69.9 91.6 97.0 98.8 99.4 99.6 100.0pyrrolidone SulfatePolyvinyl- Sodium Lauryl 9.9 0.2 89.9 60.7 70.0 89.0 83.9 85.8 91.6 93.5 94.8 95.6pyrrolidone SulfatePolyvinyl- Benzalkonium 29.8 0.5 69.7 75.7 87.2 92.6 95.3 97.0 99.3 100pyrrolidone ChloridePolyvinyl- Dioctyl Sodium 29.8 0.5 69.7 86.5 92.9 95.5 96.8 97.4 98.3 99.8pyrrolidone SulfosaccinatePolyvinyl- Sodium Laurate 29.7 1.0 69.3 53.5 65.2 72.3 77.4 81.9 90.3 94.8pyrrolidonePolyvinyl- Bis(2-Hydroxy- 29.7 1.0 69.3 74.2 83.9 88.6 91.6 93.2 97.4 100.00 100.6pyrrolidone ethyl) Oleyl AmineHydroxypropyl Sodium Lauryl 24.9 0.2 74.9 85.4 93.2 96.7 98.3 99.3 101.9Cellulose SulfateHydroxypropyl Sodium Lauryl 19.9 0.2 79.9 61.9 71.6 77.4 81.5 84.5 94.2 99.4 101.9 109.0Cellulose SulfateHydroxypropyl Sodium Lauryl 32.8 1.5 65.8 36.8 49.0 57.4 69.8 67.7 88.4 101.3 108.4 112.9Methyl Cellulose SulfatePolyethylene Sodium Lauryl 49.6 0.7 99.6 71.2 83.2 89.6 92.9 94.5 98.3 99.4 99.6Glycol SulfatePolyoxyethylene Sodium Lauryl 44.6 0.7 49.6 43.2 56.7 63.8 68.6 72.3 81.3 85.4 87.7 89.0Polyoxypropylene SulfateCopolymer__________________________________________________________________________ *Saturation 11.6 mg liter. EXAMPLE 16 The relative bioavailability of the composition of this invention with two different polymer mixtures and that of one marketed ultramicrosize griseofulvin dosage form was studied in humans. The urinary excretion of the major griseofulvin metabolite 6-Desmethyl griseofulvin (6-DMG) was determined for all three dosage forms following the administration of 250 mg of griseofulvin (in the form of 125 mg tablets) to 15 healthy adult volunteers divided into three groups using a crossover experimental design. The total tablet weight for each of the 125 mg dosages was 350 mg. The compositions of the invention were represented by spray dried griseofulvin mixtures with either polyvinylpyrrolidone or hydroxypropyl cellulose both treated with SLS. The marketed product evaluated was Schering's Fulvicin® P/G which is perceived as providing maximum bioavailability or absorption following oral administration. The results indicated that there were no statistically significant differences between the 3 dosage forms evaluated. The cumulative mean for all groups expressed in mg of either free or total 6-DMG found in the urine for each of the three dosages was as follows: ______________________________________ Gris-hydroxypropyl Marketed Gris-PVP cellulose Product Free Total Free Total Free Total______________________________________0-24 hours 48:6 75.8 50.3 81.1 48.9 76.724-48 hours 19.1 30.0 20.7 33.3 19.5 37.10-48 hours 68.7 105.8 71.0 114.4 68.4 113.8______________________________________ In a second bioavailability study conducted with 4 healthy adult volunteers, dosage forms containing 500 mg of micronized griseofulvin were administered in the form of a single tablet or 2 capsules each containing 250 mg of micronized griseofulvin. Since griseofulvin is not a dose dependent drug, twice the amount of the 6-DMG metabolite should be excreted over that of a 250 mg dosage of griseofulvin. The cumulative mean was as follows: ______________________________________ 500mg Griseofulvin 500mg Griseofulvin Tablet as 2 × 250mg capsules Free Total Free Total______________________________________0-24 hours 34.4 35.5 38.0 54.724-48 hours 63.5 104.2 64.4 102.80-48 hours 97.9 157.9 102.4 157.5______________________________________ EXAMPLE 17 Typical direct compression tablet formulations may be prepared as follows for 125 mg dosage forms having a final tablet weight of 350 mg. ______________________________________A. 1. Griseofulvin at 59.5% in mixture with hydroxypropyl cellulose, SLS treated 210.0 g2. Microcrystalline Cellulose 87.0 g3. Lactose, Edible 32.0 g4. Sodium Starch Glycolate 17.5 g5. Magnesium Stearate U.S.P. 3.5 g Theoretical Tablet Weight 350 mg.B. 1. Griseofulvin at 67.5% in PVP mixture treated with SLS 185.0 g2. Microcrystalline Cellulose 87.0 g3. Lactose, Edible 67.0 g4. Sodium Starch Glycolate 17.5 g5. Magnesium Stearate 3.5 g Theoretical Tablet Weight 350 g______________________________________ In both A and B, ingredients 1-4 were blended together until uniform, passed through a screen, blended with ingredient 5 and compressed at the correct tablet weight. The dissolution profile for the compressed tablets demonstrated further that there was no significant difference in dissolution for the formulated tablet as compared with the unformulated powdered material.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This is a U.S. National Phase of International Application PCT/US99/18908, Aug. 18, 1999, which claims priority to U.S. Provisional Patent Application Ser. No. 60/097,228 filed on Aug. 20, 1998, the disclosures of which are incorporated herein by reference in their entirety. TECHNICAL FIELD The present invention relates to the preparation of ring modified cyclic peptide analogs by replacing peptide unit(s) in the cyclic peptide ring nucleus of natural products or semi-synthetic derivatives thereof, in particular, Echinocandin-type compounds, and novel semi-synthetic cyclic peptide compounds produced therefrom. BACKGROUND ART Echinocandin B is a natural product with antifungal activity that has been modified in the past in a variety of ways. For example, simple derivatives have been made including dihydro-and tetrahydro-reduction products and modification of active groups pendant from the ring nucleus. The most common approach has been replacement of the N-acyl side chain. For example, U.S. Pat. Nos. 4,293,489; 4,320,052; 5,166,135; and 5,541,160; and EP 359529; 448353; 447186; 462531; and 561639 describe a variety of N-acyl derivatized Echinocandin-type compounds that provide varying degrees of antifungal and antiprotozoal activities. Other modifications have included acylation of the hydroxyl group of the pendant phenolic group. For example, GB 2,242,194; and EP 448343; 448354; 503960 and 525889 describe the introduction of acyl, phosphono and sulfo radicals having a charged group at neutral pH to impart water solubility. GB 2,241,956 and EP 448355 describe hydrogen-reduction products of cyclohexapeptide compounds. A review of the Echinocandin families and their semi-synthetic analogs may be found in Turner, W., et al, Current Pharmaceutical Design , 2, 209-224 (1996). The review compares the in vitro and in vivo activities of the Echinocandin natural products and their semi-synthetic analogs. Each of the approaches described above are limited to reactions with active groups pendant to the cyclic peptide ring nucleus. Some have attempted to build the entire cyclic peptide nucleus synthetically. (See, i.e., U.S. Pat. No. 5,696,084 ; J. Am. Chem. Soc ., 108, 6041 (1986); Evans, D. A., et al., J. Am. Chem. Soc ., 109, 5151 (1987); J. Med. Chem ., 35, 2843 (1992); and Kurokawa, N., et al., Tetrahedron , 49, 6195 (1993).) However, this approach is not cost effective and may lead to racemic mixtures. Therefore, there is a need to provide a more flexible and cost effective process for modifying the cyclic hexapeptide nucleus of natural products to broaden the scope of potential antifungal candidates. Several investigators have disclosed the preferential cleavage of an amide bond in compounds bearing hydroxyl groups in the delta and gamma positions relative to the amide bond to provide asymmetric lactones using acids such as hydrochloric acid and trifluoroacetic acid; however, none have applied the process to the cleavage of a terminal amino acid group of a linear peptide. (See, i.e., K. Tanaka, et al., Tetrahedron Lett , 26(10), 1337 (1985); N. Baba, et al., Chem Lett (5), 889 (1989); H. Yoda, et al, Chem Express , 4(8), 515 (1989); and Y. Yamamoto, et al., J Org Chem , 56(3), 112 (1991).) BRIEF SUMMARY OF THE INVENTION The present invention provides a method for modifying the cyclic peptide ring system of Echinocandin-type compounds to produce new analogs having antifungal activity. The inventive process allows one to make changes in the cyclic peptide structure of natural and semi-synthetic products that were previously not possible. For example, one may incorporate features such as water-solubility into the cyclic peptide ring nucleus, sites for further modification, increase or decrease the number of amino acid or peptide units within the ring nucleus, and increase or decrease the total number of members (or atoms) in the ring nucleus. The process includes the steps of (i) providing a cyclic peptide compound comprising a peptide unit having a γ-hydroxyl group; (ii) opening the ring of the cyclic peptide compound to provide a first linear peptide wherein the peptide unit having a γ-hydroxyl group is the N-terminus peptide unit of the first linear peptide; (iii) cleaving-off the peptide unit having a γ-hydroxyl group to provide a second linear peptide (preferably by adding trifluoroacetic acid or hydrochloric acid to the first linear peptide in an organic solvent); (iv) attaching at least one amino acid, a dipeptide unit or a synthetic unit to the second linear peptide to produce a third linear peptide; (v) cyclizing the third linear peptide to produce a modified cyclic peptide compound having a modified ring nucleus. Alternatively, a second peptide unit may be cleaved-off the second linear peptide produced in step (iii) prior to attaching the amino acid, dipeptide or synthetic unit(s) in step (iv) and subsequent cyclization in step (v). The addition of two or more units in step (iv) may be accomplished in a stepwise fashion (e.g., first one unit is attached then a second unit is attached). Of particular interest is the modification of Echinocandin-type compounds to produce novel cyclic hexapeptide and heptapeptide compounds that show inhibition of fungal and parasitic activity. The process also provides a convenient means to produce cyclic peptide compounds having the formulas I and II (including pharmaceutically acceptable salts, esters and hydrates thereof). where R is an alkyl group, an alkenyl group, an alkynyl group, an aryl group, or heteroaryl group; R2 is —H or —CH 3 ; R3 is —H, —CH 3 , —CH 2 CONH 2 or —CH 2 CH 2 NH 2 ; R4 is —H or —OH; R5 is —OH, —OPO 3 H 2 , or —OSO 3 H; R6 is —H or —OSO 3 H; R7 is —CH 3 or —H; (Y) is represented by the following formula wherein A is —(CH 2 ) a — where a 1-4, —CHR′—CHR″—(CH 2 ) b —, where R′ and R″ are independently —H, —OH, C 6 H 5 O—, —SH, —NH 2 , C n H 2n+1 NH—, C n H 2n+1 O—, C n H 2n+1 S— or C n H 2n+1 , where n=1-4 and b=0-1, —(CH 2 ) c —C(O)NH(CH 2 ) d —, where c=1-2 and d=1-2, —N=CH—(CH 2 ) e — where e=0-2, —NR′″(CH 2 ) f —, where R′″ is —H, —C(O)CH 2 NH 2 , —C(O)CH(NH 2 )CH 2 NH 2 or —C n H 2n+1 where n=1-4 and f=1-3, —(CH 2 ) g —SO 2 —(CH 2 ) h — where g=1-2 and h=1-2, where j is 1 or 2 and Z is an amino group, alkylamino group, or piperidyl amino group; B is a substituted or unsubstituted C1 to C6 alkyl group (e.g., isopropyl, p-hydroxybenzyl, hydroxymethyl, or α-hydroxyethyl); and W is a hydrogen or C(O)R where R is as defined above. In another embodiment of the present invention, novel cyclic peptide compounds are provided having the formulas I and II (above) wherein A is —(CH 2 ) a — where a=1, 2 or 4, —CHR′—CHR″—(CH 2 ) b — where R′ and R″ are independently —H, —OH, C 6 H 5 O—, —SH, —NH 2 , C n H 2n+1 NH—, C n H 2n+1 O, C n H 2n+1 S—or C n H 2n+1 , where n=1-4 and b=0, —(CH 2 ) c —C(O)NH(CH 2 ) d — where c=1-2 and d=1-2, —N=CH—(CH 2 )— where e=0-2, —NR′″(CH 2 ) f — where R′″ is —H, —C(O)CH 2 NH 2 , —C(O)CH(NH 2 )CH 2 NH 2 or where n=1-4 and f=1-3, —(CH 2 )—SO 2 —(CH 2 ) h — where g=1-2 and h=1-2, where j is 1 or 2 and Z is an amino group, alkylamino group, or piperidylamino group. In yet another embodiment of the present invention, a pharmaceutical composition is provided comprising the novel compounds I and II described above (including pharmaceutically acceptable salts, esters and hydrates thereof) in a pharmaceutically inert carrier. Methods for using the novel compounds and pharmaceutical compositions described above for inhibiting fungal growth and parasitic activity are also provided, as well as a method for treating a fungal infection in a human comprising administering to a human in need of such treatment a therapeutically effective amount of the novel antifungal compound described above. As used herein, the term “Echinocandin-type compounds” refers to compounds having the following general structure including any simple derivatives thereof: wherein R is an alkyl group, an alkenyl group, an alkynyl group, an aryl group, or heteroaryl group; R 1 is —H or —OH; R 2 is —H or —CH 3 ; R 3 is —H, —CH 3 , —CH 2 CONH 2 or —CH 2 CH 2 NH 2 ; R 4 is —H or —OH; R 5 is —OH, —OPO 3 H 2 , or —OSO 3 H; and R 6 is —H or —OSO 3 H. The term “alkyl” refers to a hydrocarbon radical of the general formula C n H 2n+1 containing from 1 to 30 carbon atoms unless otherwise indicated. The alkane radical may be straight, branched, cyclic, or multi-cyclic. The alkane radical may be substituted or unsubstituted. Similarly, the alkyl portion of an alkoxy group or alkanoate have the same definition as above. The term “alkenyl” refers to an acyclic hydrocarbon containing at least one carbon-carbon double bond. The alkene radical may be straight, branched, cyclic, or multi-cyclic. The alkene radical may be substituted or unsubstituted. The term “alkynyl” refers to an acyclic hydrocarbon containing at least one carbon-carbon triple bond. The alkyne radical may be straight, or branched. The alkyne radical may be substituted or unsubstituted. The term “aryl” refers to aromatic moieties having single (e.g., phenyl) or fused ring systems (e.g., naphthalene, anthracene, phenanthrene, etc.). The aryl groups may be substituted or unsubstituted. Substituted aryl groups include a chain of aromatic moieties (e.g., biphenyl, terphenyl, phenylnaphthalyl, etc.) The term “heteroaryl” refers to aromatic moieties containing at least one heteratom within the aromatic ring system (e.g., pyrrole, pyridine, indole, thiophene, furan, benzofuran, imidazole, pyrimidine, purine, benzimidazole, quinoline, etc.). The aromatic moiety may consist of a single or fused ring system. The heteroaryl groups may be substituted or unsubstituted. Within the field of organic chemistry and particularly within the field of organic biochemistry, it is widely understood that significant substitution of compounds is tolerated or even useful. In the present invention, for example, the term alkyl group allows for substituents which is a classic alkyl, such as methyl, ethyl, propyl, hexyl, isooctyl, dodecyl, stearyl, etc. The term group specifically envisions and allows for substitutions on alkyls which are common in the art, such as hydroxy, halogen, alkoxy, carbonyl, keto, ester, carbamato, etc., as well as including the unsubstituted alkyl moiety. However, it is generally understood by those skilled in the art that the substituents should be selected so as to not adversely affect the pharmacological characteristics of the compound or adversely interfere with the use of the medicament. Suitable substituents for any of the groups defined above include alkyl, alkenyl, alkynyl, aryl, halo, hydroxy, alkoxy, aryloxy, mercapto, alkylthio, arylthio, mono- and di-alkyl amino, quaternary ammonium salts, aminoalkoxy, hydroxyalkylamino, aminoalkylthio, carbamyl, carbonyl, carboxy, glycolyl, glycyl, hydrazino, guanyl, and combinations thereof. DETAILED DESCRIPTION OF THE INVENTION The synthetic scheme outlined below illustrates the general procedures for modifying the cyclic peptide ring system of Echinocandin-type compounds while maintaining chirality. The cyclic peptide ring of any Echinocandin-type natural product or semi-synthetic derivative can be opened and the terminal ornithine peptide unit cleaved so long as the γ-hydroxyl group of the ornithine peptide unit is present and not blocked. The term “natural product” refers to those secondary metabolites, usually of relatively complex structure, which are of more restricted distribution and more characteristic of a specific source in nature. Suitable natural product starting materials belonging to the Echinocandin cyclic peptide family include Echinocandin B, Echinocandin C, Aculeacin Aγ, Mulundocandin, Sporiofungin A, Pneumocandin A 0 , WF11899A, and Pneumocandin B 0 . For illustrative purposes, the following synthetic scheme starts with Cilofungin. As shown above, the cyclic hexapeptide ring (1) is first opened using base catalysis and then reduced with sodium borohydride to give the linear hexapeptide (2). Upon treatment with triethyl silane in trifluoroacetic acid (TFA), the benzylic hydroxyl is removed and the ornithine unit is cleaved to give the linear pentapeptide (3). The linear pentapeptide (2) can now be protected and the primary amide activated to provide an intermediate (4) which can be recyclized with a new amino acid unit or other synthetic unit to produce a new cyclic compound (5). Cyclic compound (5) can be further modified by deprotecting and acylating the pendant amino group (if present) to provide modified cyclic compound (6) having an N-acyl side chain. Those skilled in the art will appreciate that the N-acyl side chain encompasses a variety of side chain moieties known in the art. Suitable side chain moieties include substituted and unsubstituted alkyl groups, alkenyl groups, alkynyl groups, aryl groups, heteroaryl groups and combinations thereof. Preferably, the side chain contains both a linearly rigid section and a flexible alkyl section to maximize antifungal potency. In addition, further modifications can be made on any new functionality introduced by the incorporation of the new amino acid, peptide or synthetic unit(s) containing such new functionality. Alternatively, another peptide unit can be cleaved from intermediate (3) to provide a tetrapeptide (7) which can be recyclized with a new amino acid unit, dipeptide unit, or other synthetic unit to produce a new cyclic compound (8). Like cyclic compound (5), compound (8) can also be further modified by deprotecting and acylating the pendant amino group (if present) to attach an N-acyl side chain or modification of any new functionality introduced through the incorporation of the new amino acid, peptide or synthetic units. As illustrated in the synthetic scheme above, the ring nucleus is selectively opened at the C-terminus L-proline, N-terminus R-omithine linkage using standard base catalysis well known to those skilled in the art. Once the cyclic hexapeptide is open, then the terminal omithine amino acid may be cleaved and a new amino acid (or other synthetic unit) attached using standard peptide formation processes (or condensation processes) well known to those skilled in the art. The terminal ornithine unit is cleaved with trifluoroacetic acid or hydrochloric acid in an organic solvent such as methylene chloride, toluene, or dioxane. The preferred reaction condition is trifluoroacetic acid in methylene chloride. Any amino acid or peptide unit may be attached to the linear peptide. Theoretically, it is also possible to condense other synthetic units onto the peptide that are capable of cyclization. For example, a sulfonamide linkage may be formed between a terminal amino group on the linear peptide and a sulfonyl group on a synthetic unit. Any number of other linkages may also be envisioned; however, the pharmaceutical activity of such compounds are currently unknown. The insertion of a new amino acid, dipeptide unit or other synthetic unit allows one to change the size of the cyclopeptide ring. The number of atoms in the ring system may be increased or decreased from the original 21 membered Echinocandin ring structure depending upon the particular compound(s) inserted into the ring. Theoretically, the ring size is limited only by the configuration of the linear peptide. If the linear peptide is too short or too long, the ends cannot come into close enough proximity to react and the ends may polymerize with another linear peptide rather than close to form a ring. The optimum configuration of the linear peptide for ring closure will vary depending upon the particular amino acids that make-up the peptide structure. For Echinocandin-type compounds, preferably, the final ring structure contains between 19 to 22 members, more preferably, the final ring structure is a 21- or 22-membered ring, most preferably the final ring structure is a 21-membered ring. It is well-known that the acyl side chain pendant from the Echinocandin ring structure plays an important role in the activity of both the natural products and semi-synthetic Echinocandin type materials. Consequently, any amino acid or synthetic unit may be used for insertion into the ring so long as the final cyclized product contains at least one amino group capable of acylation. When the inserted compound contains more than one unit, the units may be attached one at a time to the linear penta- or tetra-peptide or the individual units can be combined and then added to the linear penta- or tetra-peptide as a block unit. Preferably, the units are added as a block unit to minimize racemization. Acylation of the amino group may be accomplished in a variety of ways well known to those skilled in the art. For example, the amino group may be acylated by reaction with an appropriately substituted acyl halide, preferably in the presence of an acid scavenger such as a tertiary amine (e.g., triethylamine). The reaction is typically carried out at a temperature between about −20° C. to 25° C. Suitable reaction solvents include polar aprotic solvents, such as dioxane or dimethylformamide. Solvent choice is not critical so long as the solvent employed is inert to the ongoing reaction and the reactants are sufficiently solubilized to effect the desired reaction. The amino group may also be acylated by reaction with an appropriately substituted carboxylic acid, in the presence of a coupling agent. Suitable coupling agents include dicyclohexylcarbodiimide (DCC), N,N′-carbonyldiimidazole, bis(2-oxo-3-oxazolidinyl)phosphinic chloride (BOP-Cl), N-ethoxycarbonyl-2-ethoxy-1,2-dihydroquinoline (EEDQ), benzotriazole-1-yloxy-tripyrrolidinophosphonium hexafluorophosphate (PyBOP) and the like. Alternately, the amino group may be acylated with an activated ester of a carboxylic acid such as p-nitrophenyl, 2,4,5-trichlorophenyl, hydroxybenzotriazole hydrate (HOBT.H 2 O), pentafluorophenol, and N-hydroxysuccinimide carboxylate esters. Preferred acylating moieties are the 2,4,5-trichlorophenyl and HOBT carboxylate esters. The reaction is typically ran 1 to 65 hours at a temperature from about 0° C. to 30° C. in an aprotic solvent. The reaction is generally complete after about 24 to 48 hours when carried out at a temperature between about 15° C. to 30° C. Suitable solvents include tetrahydrofuran and dimethylformamide or mixtures thereof. The amino group is generally present in equimolar proportions relative to the activated ester or with a slight excess of the amino group. The compounds of the present invention may be isolated and used per se or in the form of its pharmaceutically acceptable salt or hydrate. The term “pharmaceutically acceptable salt” refers to non-toxic acid addition salts derived from inorganic and organic acids. Suitable salt derivatives include halides, thiocyanates, sulfates, bisulfates, sulfites, bisulfites, arylsulfonates, alkylsulfates, phosphonates, monohydrogenphosphates, dihydrogenphosphates, metaphosphates, pyrophosphonates, alkanoates, cycloalkylalkanoates, arylalkonates, adipates, alginates, aspartates, benzoates, fumarates, glucoheptanoates, glycerophosphates, lactates, maleates, nicotinates, oxalates, palmitates, pectinates, picrates, pivalates, succinates, tartarates, citrates, camphorates, camphorsulfonates, digluconates, trifluoroacetates, and the like. The ring-modified compounds may be used in a variety of pharmaceutical formulations. A typical formulation comprises the ring-modified compound (or its pharmaceutically acceptable salt, ester or hydrate) in combination with a pharmaceutically acceptable carrier, diluent or excipient. The active ingredient is typically formulated into pharmaceutical dosage forms to provide an easily controllable dosage of the drug and to give the patient an elegant and easily handleable product. Formulations may comprise from 0.1% to 99.9% by weight of active ingredient, more generally from about 10% to about 30% by weight. As used herein, the term “unit dose” or “unit dosage” refers to physically discrete units that contain a predetermined quantity of active ingredient calculated to produce a desired therapeutic effect. When a unit dose is administered orally or parenterally, it is typically provided in the form of a tablet, capsule, pill, powder packet, topical composition, suppository, wafer, measured units in ampoules or in multidose containers, etc. Alternatively, a unit dose may be administered in the form of a dry or liquid aerosol which may be inhaled or sprayed. The dosage to be administered may vary depending upon the physical characteristics of the patient, the severity of the patient's symptoms, and the means used to administer the drug. The specific dose for a given patient is usually set by the judgment of the attending physician. Suitable carriers, diluents and excipients are well known to those skilled in the art and include materials such as carbohydrates, waxes, water soluble and/or swellable polymers, hydrophilic or hydrophobic materials, gelatin, oils, solvents, water, and the like. The particular carrier, diluent or excipient used will depend upon the means and purpose for which the active ingredient is being applied. The formulations may also include wetting agents, lubricating agents, emulsifiers, suspending agents, preservatives, sweeteners, stabilizers, perfuming agents, flavoring agents and combinations thereof. A pharmaceutical composition may be administered using a variety of methods. Suitable methods include topical (e.g., ointments or sprays), oral, injection and inhalation. The particular treatment method used will depend upon the type of infection being addressed. Echinocandin-type compounds have been shown to exhibit antifungal and antiparasitic activity such as growth inhibition of various infectious fungi including Candida spp. (i.e., C. Albicans, C. Parapsilosis, C. Krusei, C. Glabrata, C. Tropicalis , or C. Lusitaniaw ); Torulopus spp.(i.e., T. Glabrata ); Aspergillus spp. (i.e., A. Fumigatus ); Histoplasma spp. (i.e., H. Capsulatum ); Cryptococcus spp. (i.e., C. Neoformans ); Blastomyces spp. (i.e., B. Dermatitidis ); Fusarium spp.; Trichophyton spp., Pseudallescheria boydii, Coccidioides immits, Sporothrix schenckii , etc. Compounds of this type also inhibit the growth of certain organisms primarily responsible for opportunistic infections in immunosuppressed individuals, such as growth inhibition of Pneumocystis carinii (the causative organism of pneumocystis pneumonia (PCP) in AIDS and other immunocompromised patients. Other protozoans that are inhibited by Echinocandin-type compounds include Plasmodium spp., Leishmania spp., Trypanosoma spp., Cryptosporidium spp., Isospora spp., Cyclospora spp., Trichomnas spp., Microsporidiosis spp., etc. The compounds of the present invention are useful in combating either systemic fungal infections or fugal skin infections. Accordingly, a method is provided for inhibiting fungal activity comprising contacting a compound of formula I or II (or a pharmaceutically acceptable salt, ester or hydrate thereof) with a fungus. A preferred method includes inhibiting Candida albicans or Aspergillus fumigatis activity. The term “contacting” includes a union or junction, or apparent touching or mutual tangency of a compound of the invention with a parasite or fungus. The term does not imply any further limitations to the process, such as by mechanism of inhibition. The methods are defined to encompass the inhibition of parasitic and fungal activity by the action of the compounds and their inherent antiparasitic and antifungal properties. A method for treating a fungal infection which comprises administering an effective amount of a compound of formula I or II (or a pharmaceutically acceptable salt, ester or hydrate thereof) to a host in need of such treatment is also provided. A preferred method includes treating a Candida albicans or Aspergillus fumigatis infection. The term “effective amount” refers to an amount of active compound which is capable of inhibiting fungal activity. The dose administered will vary depending on such factors as the nature and severity of the infection, the age and general health of the host and the tolerance of the host to the antifungal agent. The particular dose regimen likewise may vary according to these factors. The medicament may be given in a single daily dose or in multiple doses during the day. The regimen may last from about 2-3 days to about 2-3 weeks or longer. A typical daily dose (administered in single or divided doses) contains a dosage level between about 0.01 mg/kg to 100 mg/kg of body weight of an active compound. Preferred daily doses are generally between about 0.1 mg/kg to 60 mg/kg and more preferably between about 2.5 mg/kg to 40 mg/kg. Although the compounds described herein may be used for inhibiting fungal and parasitic activity in a variety of circumstances (e.g., humans, animals, agriculture, etc.), preferably, the methods of use are limited to the treatment of humans to reduce the potential for developing resistance to the pharmaceutical. EXAMPLES Unless indicated otherwise, all chemicals can be acquired from commercial suppliers such as Aldrich Chemical (Milwaukee, Wis.), Sigma, and other commercial sources well-known to those skilled in the art. The following acronyms are representative of the corresponding functional groups or compounds: BOC=t-butoxycarbonyl, (CH 3 ) 3 C—O—C(O)— CBZ=benzyloxycarbonyl, C 6 H 5 CH 2 —O—C(O)— o-Cl-CBZ=ortho-chlorobenzyloxycarbonyl FMOC=fluorenylmethyloxycarbonyl TBDMS=t-butyldimethylsilyl TFA=trifluoroacetic acid AcN=acetonitrile DMF=dimethylformamide THF=tetrahydrofuran TDM=4,4′-tetramethyl-diamino-diphenylmethane CAM=ceric ammonium molybdate The following set of examples illustrate the general reaction conditions for cleaving and inserting new unit(s) into a cyclohexapeptide nucleus. Preparation of Key Intermediates Ring Opening and Reduction of Cilofungin (1) to Give Intermediate I-2. To a stirred solution of Cilofungin (1) (100 g; 96 mmol) in 350 ml of 55% acetonitrile/45% water was added 1 N sodium hydroxide solution (40 ml). The reaction was monitored by high pressure liquid chromatography (C-18 column, 50% AcN/water, 230 nm). After 1 hour, the reaction mixture contained >90% of the intermediate aldehyde. Next, sodium borohydride (1.8 g; 48 mmol) was added and the stirring continued for 20 min. HPLC showed complete conversion to the final alcohol product. The reaction was quenched by adding acetic acid dropwise until the evolution of gas was complete. Most of the acetonitrile was removed by rotary evaporation followed by lyophilization to remove the remainder to give 98.1 g of a mixture of the solid product I-2 and inorganic salts. (93% pure by HPLC) Peptide Cleavage and Deoxygenation of I-2 to Give Pentapeptide (I-3) The unpurified mixture of Compound I-2 (98.1 g) described above was dissolved in trifluoroacetic acid (300 ml) and dichloromethane (100 ml). The mixture was cooled in an ice bath. Triethylsilane (32 ml; 0.2 mol) was added and the reaction was stirred at 0° C. for 1 hour. The ice bath was removed and the reaction was left at ambient temperature for 18 hrs. The solvent was removed in vacuo and the residue redissolved in methanol for HPLC purification. The residue was purified by passage through a C-18 column with 50% acetonitrile/water; 0.1% TFA to remove more lipophilic byproducts. The polar peaks were purified with 10% acetonitrile/water; 0.1% TFA. Lyophilization gave 57.8 g (98% yield) of pure pentapeptide trifluoroacetic acid salt (I-3). FAB MS=653.3 (M+1) Preparation of CBZ Pentapeptide (I-4) To an ice bath cooled solution of I-3 (50.3 g, 66 mmol) in water (200 ml) and tetrahydrofuran (100 ml) was added excess solid sodium bicarbonate until no additional foaming occurred and pH>8. Carbobenzyloxy chloride (10 ml, 70 mmol) was added and the reaction was monitored by HPLC (25% AcN/water, 0.1% TFA, 230 nm). The pH was monitored and occasionally more sodium bicarbonate was added to keep the solution basic. After 1 hour, the reaction was complete and the solvent was removed in vacuo. The residue was slurried in methanol, the solid inorganics removed by filtration, and the solution was passed through a preparative HPLC (25% methanol/water). Removal of solvents gave 25.2 g (49% yield) of I-4 as a white foam. FAB MS=787.38 (M+1) Preparation of Silyl CBZ Pentapeptide (I-5) Compound I-4 (25.2 g, 32 mmol), imidazole (20.6 g, 303 mmol), and t-butyldimethylsilyl chloride 45.6 g, 303 mmol) in dimethylformamide (250 ml) were mixed while following the reaction by TLC (25% ethyl acetate/hexane). After 6 hours, the solvent was removed in vacuo and the residue was slurried and sonicated in ether. The ether solution was washed with 1N HCl, dried over MgSO 4 and reduced in vacuo to give a foam. The crude product was purified by flash chromatography (600 g silica, 25% ethyl acetate/hexane) to give 32.9 g (70% yield) of a white foam. NMR data was consistent with the structure I-5. FAB MS=1472.9 (M) Preparation of DiBOC CBZ Silyl Pentapeptide (I-6) Compound I-5 (32.9 g, 22.3 mmol) was dissolved in acetonitrile (250 ml) and tetrahydrofuran (50 ml). Di-t-butyl dicarbonate (16.1 g, 73.6 mmol) and dimethylaminopyridine (299 mg, 2.2 mmol) were added with stirring. The reaction was followed by TLC (20% ethyl acetate/hexane) and an additional 3 g of di-t-butyl dicarbonate was added after 2 hrs. After an additional 2.5 hours, several ml of acetic acid were added to quench the dimethylaminopyridine. The solvent was removed in vacuo keeping the temperature less than 40° C. The residue was chromatographed (500 g silica, 15% ethyl acetate/hexane) to give 33.6 g (89% yield) of a white foam. NMR data was consistent with the structure I-6. FAB MS=1672.0 (M) Preparation of the Intermediate Linear Tetrapeptide (I-7): To a solution of Pentapeptide Compound I-3 (5.75 g, 7.50 mmol) in anhydrous DMF (200 ml) was added NaHCO 3 (690 mg, 8.25 mmol) and phenyl isothiocyanate (0.99 ml, 8.25 mmol), and the reaction stirred at room temperature for 36 hours. The solids were removed by filtration and the filtrate was concentrated in vacuo. The resulting oil was dissolved in TFA (70 ml) and stirred at room temperature for 1 hour, followed by removal of the solvent in vacuo. The resulting solids were treated with water (150 ml), sonicated, and the insoluble materials were removed by filtration. Reverse phase HPLC of the filtrate (eluting with 4% AcN/0.1% TFA/H 2 O) followed by lyophilization gave 3.20 g of a fluffy white solid, 64% yield. The 1 H NMR (300 MHz)spectrum was consistent with the structure I-7. FAB MS (M + of free base)=552. Example 1 illustrates the general reaction conditions for converting pentapeptide intermediate (I-6) into a cyclic hexapeptide analog of an Echinocandin-type compound. Example 1 Preparation of DiBOC silyl o-Cl-CBZ Hexapeptide (E1-1) A solution of N-α-BOC-N-γ-(2-chloro CBZ)—L-ornithine (480 mg, 1.2 mmol), N-hydroxysuccinimide (138 mg, 1.2 mmol), and dicyclohexylcarbodiimide (247 mg, 1.2 mmol) in 4 ml of tetrahydrofuran was stirred overnight to form the active ester. A solution of I-6 (1.0 g, 0.598 mmol) in ethanol (5 ml) was added to a slurry of 10% Pd/C (250 mg) in 5 ml of ethanol followed by 10 ml of glacial acetic acid. The mixture was put under a balloon of H 2 and after 1 hour the starting material was gone. The catalyst was removed by filtration and the solution was carefully reduced under high vacuum keeping the temperature under 40° C. The resulting oil was dissolved in ether and the previously prepared tetrahydrofuran solution of active ester was added followed by excess triethylamine until the solution was basic to pH paper. After stirring for 2 hours, the solution was extracted with saturated NaHCO 3 solution followed by dilute HCl solution and then another portion of saturated NaHCO 3 solution. The organic layer was dried over MgSO 4 and reduced in vacuo to give 0.85 g of the crude product. Purification by flash chromatography (25% ethyl acetate/hexane) gave 0.53 g of coupled product E1-1 (47% yield). NMR data was consistent with the structure E1-1. FAB MS=1922.2 (M+1) Cyclization of E1-1 to BOC Silyl Cyclohexapeptide (E1-2) An ethanol/acetic acid solution (10 ml of each) of E1-1 (0.53 g, 0.27 mmol) with 10% Pd/C (200 mg) was placed under a balloon of hydrogen. After 2 hours, TLC (30% ethyl acetate/hexane) indicated a complete reaction. The catalyst was removed by filtration and the solvent reduced in vacuo at 40° C. until the residue was a thick oil. The residue was dissolved in ethyl ether (150 ml) and excess triethylamine was added until the solution was basic to pH paper (−2 ml). After 18 hours, TLC indicated a single product spot. The solvent was removed in vacuo and the residue purified over a flash column to provide 343 mg of a white solid (81% yield). NMR data was consistent with the structure E1-2. FAB MS=1536.0 (M+1) Removal of Protecting Groups and Coupling of the Side Chain to Give E1-3 Compound E1-2 (510 mg, 0.332 mmol) was dissolved in 5 ml trifluoroacetic acid at 0° C. After 0.5 hour, water (0.5 ml) was added and the mixture stirred for 0.5 hour longer. The solvent was removed in vacuo and the residue was dissolved in 1N HCl (2 ml) and tetrahydrofuran (2 ml). The solution was refrigerated for 48 hours after which HPLC analysis (15% AcN/water, 230 nm) showed a single product peak. The solvent was removed under high vacuum giving a foam residue which was dissolved in dimethylformamide (8 ml). The terphenyl hydroxybenzotriazole active ester (191 mg, 0.4 mmol) and triethylamine (0.2 ml, 1.4 mmol) were added to the solution. After 4 hours, HPLC (60% AcN/water, 230 nm) showed complete conversion to a new product peak. The solvent was removed under high vacuum and purified by preparative HPLC using the analytical conditions. Solvent removal from the pure fractions gave 238 mg (66% yield) of a white solid. NMR data was consistent with the structure E1-3. FAB MS calculated for C 58 H 74 N 7 O 14 1092.5294; found 1092.5301 (M). The following examples provide further illustrations of converting key intermediate (I-6) into a cyclic hexapeptide analog. In a similar manner I-6 was converted to each of the following cyclic peptides: Coupling with Nα-BOC-Nβ-CBZ-D-ornithine and subsequent cyclization gave 63.9 mg of E1-4 (21-membered ring). FAB MS calculated for C 58 H 74 N 7 O 14 1092.5294; found 1092.5280. Coupling with Nα-BOC-Nε-CBZ-L-lysine and subsequent cyclization gave 44.1 mg of E1-5 (22-membered ring). FAB MS calculated for C 59 H 76 N 7 O 14 1106.5450; found 1106.5464. Coupling with Nα-FMOC-Nδ-CBZ-L-2,4-diaminobutyric acid and subsequent cyclization gave 65.0 mg of E1-6 (20-membered ring). FAB MS calculated for C 57 H 72 N 7 O 14 =1078.5137; found 1078.5128. Coupling with Nα-BOC-Nβ-CBZ-L-2,3-diaminopropionic acid and subsequent cyclization gave 25.5 mg of E1-7 (19-membered ring). FAB MS calculated for C 56 H 70 N 7 O 14 1064.4981; found 1064.4994. Table 1 summarizes the activity data for compounds E1-3 through E1-7 in comparison with the following comparative semi-synthetic Echinocandin compound C1 which has proven in vitro and in vivo antifungal activity. In a murine model of organ recovery, Compound C1 significantly reduced the number of A. Fumigatus recovered from the kidneys and was as effective as amphotericin B on a mg/kg basis when both were administered intraperitoneally. In a Pneumocystis carinii model, Compound C1 reduced the number of cysts in the lungs of heavily infected, immunosuppressed rats by more than 99% when administered orally at 5 mg/kg once daily for 4 days. Prophylactic oral administration of 1 mg/kg twice daily for 4 weeks resulted in >90% reduction in all life cycle forms. (see Turner, W. W. and M. J. Rodriguez, Current Pharmaceutical Design , 1996, 2, p214.) Antifungal activity of the comparative and test compounds were determined in vitro by obtaining the minimum inhibitory concentration (MIC) of the compound using a standard agar dilution test or a disc-diffusion test. TABLE 1 Minimal Inhibitory Concentration MIC (μg/ml) C. C. A. Histoplasma Example No. albicans parapsilosis fumigatus capsulatum Comparative 0.01 0.156 0.02 0.01 C1 (21-membered ring) E1-3 0.005 0.156 0.078 0.156 (21-membered ring) E1-4 1.25 >20 20.0 5.0 (21-membered ring) E1-5 0.02 >20 2.5 0.156 (22-membered ring) E1-6 0.039 >20 20 0.078 (20-membered ring) E1-7 0.312 >20 0.625 0.625 (19-membered ring) Example 2 illustrates the conversion of intermediate I-6 into an azacyclic hexapeptide analog of an Echinocandin-type compound. Example 2 Preparation of the N-BOC, Benzyl, Aldehyde Derivative of L-Homoserine (E2-1) The following procedure described in Baldwin & Flinn, Tetrahedron Lett ., 26(31), 3605, (1987) was used to prepare E2-1. A suspension of L-homoserine (5 g, 42 mmol) in 20 ml of water was treated with solid sodium bicarbonate (3.5 g, 42 mmol). The mixture was stirred at room temperature for approx. 10 minutes. A solution of di-t-butyl dicarbonate (BOC anhydride) (13.75 g, 63 mmol) in 20 ml of p-dioxane was added to the mixture and then stirred vigorously at room temperature for approx. 60 hours. The resulting homogenous solution was reduced in vacuo to yield a colorless oil. A solution of benzyl bromide (10.8 g, 63 mmol) in 50 ml of dimethyl formamide was added to the residue. Another 1.8 g (0.5 eq more) of solid sodium bicarbonate was added to the reaction and the mixture was allowed to stir at room temperature overnight. The reaction was monitored by thin layer chromatography (1:1 chloroform/methanol, plus 1 drop of glacial acetic acid, developed using TDM stain). The volatiles were removed in vacuo and ethyl acetate was added to the resulting residue. The organic layer was washed with water (2 times), then brine. The organic layer was dried over sodium sulfate, filtered and concentrated to yield 14.7 g of a light-yellow oil. The residue was dissolved in 50 ml of dimethyl sulfoxide. Triethylamine (12.7 g, 126 mmol) was added and the mixture was cooled in an ice-bath. A suspension of sulfur trioxide/pyridine complex (20 g, 126 mmol) in 50 ml of dimethylsulfoxide was added with stirring. The ice-bath was removed and the mixture was allowed to warm to room temperature. After approx. 10 minutes, the reaction mixture was poured into 200 ml of ice-water. The aqueous layer was extracted twice with ethyl acetate, the ethyl acetate extract was washed once with 0.1N sodium bisulfate, once with water and then finally with brine. The organic layer was dried over sodium sulfate, filtered and concentrated in vacuo to yield a yellow oil. Flash silica gel column purification chromatography (approx. 250 g, 30% ethyl acetate/hexane) yielded 11.1 g (86%) of a light-yellow oil. NMR and elemental analysis (C,H,N) data were consistent with structure E2-1. MS(FD+)=308 (M+H) Preparation of the Dimethyl Acetal of Compound E2-1 (E2-2) Compound E2-1 (4 g) was dissolved in 50 ml of methanol and then cooled in an ice-bath. A light blanket of HCl gas was introduced over the stirring solution (approx. 2-3 seconds of gas allowed in) and the solution was allowed to continue to stir cold. The reaction was monitored by TLC (30% ethyl acetate/hexane, CAM stain). Additional amounts of HCl gas were added as necessary to drive the reaction to completion. After approx. 2 hours, the reaction appeared to be complete. While still cold, the reaction was quenched by adding solid sodium bicarbonate and keeping the pH slightly on the basic side. The volatiles were removed in vacuo. Ether was added to the residue. The ether layer was washed once with saturated sodium bicarbonate. The aqueous layer was back-extracted with ether. The combined ether extracts were then washed once with brine and dried over sodium sulfate, filtered and concentrated in vacuo to yield 4.6 g (100%) of a clear, colorless oil. NMR and elemental analysis (CHN) data were consistent with the structure E2-2. MS(FD+)=354 (M+H) Debenzylation of Compound E2-2(E2-3) Compound E2-2 (4.2 g, 11.9 mmol) was dissolved in 50 ml of ethyl acetate. The solution was evacuated/purged with nitrogen 3 times, then 1.9 g of 5% palladium on charcoal catalyst was added. The flask was evacuated one more time and then hydrogen was introduced into the flask. The reaction was monitored by TLC (40% ethyl acetate/hexane) and after approx. 2 hours, the reaction was complete. The hydrogen was removed in vacuo, the solution was purged with nitrogen, Celite filter aid was added, stirred, filtered through a small bed of Celite on a sintered glass funnel, rinsed with ethyl acetate and the filtrate concentrated in vacuo to yield 3.1 g (100%) of a colorless oil. NMR data was consistent with the structure E2-3. MS(FD+)=264 (M+H) Elemental Analysis (CHN): Theoretical % (C−50.18; H−8.04; N−5.32) Observed % (C−51.14; H−7.56; N−5.65) Coupling of Compound 2-3 to the Di-BOC-Silyl-CBZ Pentapeptide (I-6) to Give (E2-4) Compound I-6 was dissolved in 5 ml of ethanol and added to a slurry of 200 mg of 10% Palladium on charcoal in 10 ml of ethanol (all under an atmosphere of nitrogen). Glacial acetic acid (2 ml) was added and then a hydrogen atmosphere was introduced via a balloon. Meanwhile, compound E2-3 (0.2 g, 0.76 mmol) was dissolved in 2 ml of tetrahydrofuran (Sure Seal, or freshly distilled from lithium aluminum hydride), 96 mg (0.84 mmol) of N-hydroxysuccinimide was added, followed by 172 mg (0.84 mmol) of dicyclohexylcarbodiimide. The reaction mixture was stirred at room temperature. After approx. 10 minutes, a heavy precipitate was observed. Both reactions were allowed to stir at room temperature approx. 2 to 3 hours and monitored by TLC (25% ethyl acetate/hexane, CAM stain). After completion of the hydrogenation reaction, the mixture was purged with nitrogen, Celite filter aid was added, stirred, and then filtered through a bed of Celite in a sintered glass funnel. The filtrate was concentrated in vacuo, not letting the bath temperature rise above 45° C. The residue was dissolved in 8 ml of tetrahydrofuran and then approx. 2 ml of triethylamine was added to bring the pH to between 6 to 7. The newly formed active ester from the second reaction was filtered directly into this vessel and enough triethylamine was added to keep the reaction mixture basic (approx. pH 9-10). The reaction was stirred at room temperature overnight. The reaction monitored by TLC (25% ethyl acetate/hexane, CAM stain). The volatiles were removed in vacuo, chloroform was added to the residue, the organic layer was washed once with 1N hydrochloric acid, once with saturated sodium bicarbonate solution, once more time with 1N hydrochloric acid, and finally once with brine. The solution was dried over sodium sulfate, filtered, and concentrated in vacuo to yield 1 g of E2-4 as a white foam. The material was used without further purification in the subsequent reaction. However, purification can be accomplished using flash silica gel purification chromatography (approx. 100 g of silica, 20% ethyl acetate/hexane). Yield 395 mg (37%) of a white foam. NMR data was consistent with structure E2-4. MS(FAB)=1726 (M-t-Butyl) Preparation of the Acyl Hydrazone of Compound E2-4 (E2-5) A flask was charged with compound E2-4 (374 mg, 0.21 mmol) and 8 ml of tetrahydrofuran. Hydrazine hydrate (13.6 mg, 0.27 mmol, 13.6 μl) was added and stirred at room temperature. The reaction was monitored by TLC (25% ethyl acetate/hexane, CAM stain). After approx. 15 minutes, the volatiles were removed to yield a white foam. Flash silica gel column chromatography (approx. 25 g, 25%→50% ethyl acetate/hexane) yielded 250 mg (75%) of a white foam. NMR data was consistent with the structure E2-5. MS(FAB)=1541 (M-t-Butyl) Cyclization of Compound E2-5 (E2-6) Stannous chloride (1.5 g) and solid sodium bicarbonate (400 mg) was suspended in 800 ml of methylene chloride. The mixture was stirred for approx. 15 minutes at room temperature. A solution of compound E2-5 (3.2 g) was added in 100 ml of methylene chloride. The container containing compound E2-5 was rinsed with another 100 ml of solvent and added to the reaction vessel. The reaction was monitored by TLC (40% ethyl acetate/hexane, CAM stain). After approx. 3 hours, the residual solids were filtered off and the filtrate concentrated in vacuo to yield 3 g (100%) of E2-6 as a pale-yellow solid. Any attempt at purification failed due to instability. MS(FAB)=1534 (parent ion) Borohydride Reduction of Compound E2-6 (E2-7) Compound E2-6 (6 g, 3.9 mmol) was dissolved in 400 ml of tetrahydrofuran, 425 mg (6.76 mmol) of sodium cyanoborohydride was added followed by 1 ml of glacial acetic acid. The mixture was allowed to stir at room temperature while monitoring by TLC (40% ethyl acetate/hexane, CAM stain). After approx. 2 hours, the volatiles were removed in vacuo, ethyl acetate was added to the residue, washed twice with water, once with brine, dried over sodium sulfate, filtered, and concentrated in vacuo to yield 5.2 g of a white foam. The solid was dissolved in 125 ml of methanol and allowed to stir at room temperature for 6 days. The volatiles were removed in vacuo to yield 4.8 g of a white foam. Flash silica gel column chromatography (approx. 200 g, 25%→35% ethyl acetate/hexane) yielded 2.2 g (37%) of a white foam. NMR data was consistent with the structure E2-7. MS(FAB+)=1537 (M+H) CBz Protection of Compound E2-7 (E2-8) A solution of Compound E2-7 (650 mg, 0.4 mmol) in 15 ml of tetrahydrofuran and solid sodium bicarbonate (67 mg) were added to a reaction vessel fitted with rubber septum and stir bar. The solution was flushed with nitrogen and stirred. The mixture was cooled in an ice-bath and benzyl chloroformate (144 mg, 0.8 mmol, 12 μl) was added via syringe. The mixture was stirred cold for approx. 1 hour. The ice-bath was removed and the mixture was allowed to stir at room temperature for approx. 3 hrs. The reaction was monitored by TLC (20% and 40% ethyl acetate/hexane, CAM stain). The volatiles were removed in vacuo. The residue was dissolved in ether, washed twice with water, once with dilute hydrochloric acid quickly, once with saturated sodium bicarbonate solution, once with brine, dried over sodium sulfate, filtered, and concentrated in vacuo to yield 700 mg of a white foam. Flash silica gel column chromatography (35 g of silica, 20% ethyl acetate/hexane) yielded 460 mg (65%) of a white foam. NMR data was consistent with the structure E2-8. MS(FAB)=1670 (parent ion) Deprotection of Compound E2-8 (E2-9) Compound E2-8 (1.2 g, 0.72 mmol) was dissolved in cold trifluoroacetic acid (10 ml), placed in an ice-bath and stirred for approx. 1.5 hrs. Cold water (5 ml) was added and stirring continued in the ice-bath for approx. 1 hr. The volatiles were removed in vacuo, 5 ml of tetrahydrofuran and 5 ml of 1N hydrochloric acid was added and stirred overnight at room temperature. The volatiles were removed in vacuo, toluene was added to the residue and then evaporated. The procedure was repeated two more times in order to remove the excess trifluoroacetic acid. Ether was added to the residue and then sonicated to yield a white solid. The ether was filtered off and the residue rinsed several times with ether. The residue was dried under high vacuum to yield 660 mg (100%) of a white solid. Analysis by RP-HPLC (C-18 Bondapak, 70:20:10 AcN/water/1% TFA, 230 nm) shows material to be 97% pure. NMR data was consistent with the structure E2-9. MS(FAB)=885.5 (M+H) Preparation of Compound(E2-10(b)) Compound E2-9 (600 mg, 0.68 mmol) was dissolved in 10 ml of dimethylformamide and enough diisopropyl ethylamine added to make the solution basic to pH paper (approx. 0.5 ml). The hydroxybenzotriazole active ester of the terphenyl side chain (388 mg, 0.81 mmol) was added to the reaction vessel and allowed to stir at room temperature overnight. The reaction was monitored by RP-HPLC (60:40 AcN/water, 230 nm). The solvent was removed in vacuo, and a 1:1 mixture of methanol/acetonitrile was added to the resulting residue, followed by stirring and then filtration. The resulting white solid was suspended in ether, stirred, filtered, and the process repeated. The same procedure was performed using methylene chloride, then finally one time more with ether. The residue was dried under vacuum to yield 735 mg (88%) of a white solid—Compound E2-10(a). MS(FAB)=1227.6 (parent ion) The white solid (632 mg, 0.5 mmol) was suspended in glacial acetic acid (100 ml) and subjected to catalytic hydrogenation under a balloon of hydrogen, overnight (100 mg of 10% palladium on charcoal). The reaction was monitored by reverse-phase HPLC (C-18 Bondapak, 60:30:10 AcN/water/1% TFA, 230 nm). The reaction vessel was purged with nitrogen, Celite filter aid was added, stirred, filtered through a bed of Celite in a sintered glass funnel, the catalyst was washed with a 1:1:1 mixture of methanol/AcN/water, and the filtrate was concentrated to dryness. Toluene was added and then allowed to evaporate to dryness yielding 440 mg (81%) of a white solid—Compound E2-10(b). MS(FAB)=1093.5 (parent ion) Alkylation of Deprotected Acyl Hydrazide Nucleus E 2-10 (b), Where R is Methyl, Ethyl or N-propyl (E2-11) The following procedure illustrates a typical preparation for the alkylations. Compound E2-10(b) (100 mg, 0.086 mmol) was dissolved or suspended in 10 ml of dimethyl formamide. Two equivalents of the corresponding aldehyde (for formaldehyde use 5.2 mg (15 μl)) was added (for acetaldehyde use 7.6 mg (10 μl) and for propionaldehyde use 10 mg (12.5 μl), all are 0.173 mmol), followed by enough glacial acetic acid (approx. 3-4 drops) to make the mixture acidic. Sodium cyanoborohydride (11 mg, 0.173 mmol) was added and the mixture stirred at room temperature, overnight. The reaction was monitored by reverse-phase HPLC (C-18 Bondapak, AcN/water/1% TFA (55:35:10), 280 nm). The reaction was quenched with water to obtain a clear solution and a white gummy material in the bottom of the flask. The solvents were removed in vacuo, acetonitrile was added, filtered, and washed with ether to obtain a white powder (150 mg for methyl, 250 mg for ethyl, and 250 mg for propyl). All alkylated materials were isolated using preparative RP-HPLC(50:40: 10 AcN/water/1% HCl, 230 nm for methyl and ethyl and 55:35:10 AcN/water/1% HCl, 230 nm for propyl). Yield: 64 mg for the methyl derivative E2-11(a) having a MS(FAB)=1107.54 (exact mass) 59 mg for the ethyl derivative E2-11(b) having MS(FAB)=1121.55 (exact mass) 73 mg for the propyl derivative E2-11(c) having a MS(FAB)=1135.57 (exact mass) Preparation of the Product From Coupling Glycine to Compound E2-7 (E2-12) CBz-Glycine (2 g, 9.6 mmol) was dissolved in 25 ml of tetrahydrofuran, pentafluorophenol (2.2 g, 11.9 mmol)was added, followed by 1-[3-(dimethylamino)propyl]-3-ethylcarbodiimide hydrochloride (EDAC) (2.2 g, 11.5 mmol). The mixture was stirred at room temperature under nitrogen. The reaction was monitored by TLC (40% ethyl acetate/hexane, UV and CAM stain). After approx. 1 hour, the solvent was removed in vacuo, the residue dissolved in methylene chloride, the organic layer washed once with 1 M sodium bisulfate solution, thrice with 1N sodium hydroxide and finally once with brine. The organic layer was dried over sodium sulfate, filtered and concentrated in vacuo to yield 3.3 g (92%) of a light-pink solid. The material had consistent NMR data. Compound E2-7 (700 mg, 0.45 mmol) was dissolved in 15 ml of tetrahydrofuran. The active ester from above (504 mg, 1.3 mmol) was added, plus a few drops of triethylamine. The mixture was heated near reflux for approx. 4 hours, then cooled to room temperature and allowed to stir overnight. The volatiles were removed in vacuo, ether was added to the residue, washed twice with 1N sodium hydroxide, once with brine, dried over sodium sulfate, filtered, and concentrated in vacuo to yield 1.1 g of a white foam. Flash silica gel column cleanup (20:30% ethyl acetate/hexane) yielded 0.75 g (95%) of a white foam. The material had satisfactory NMR data. MS(FAB): 1727.9 (parent ion) The silyl and BOC protecting groups were removed following the previous procedure for preparation of compound E2-9. The reaction was monitored by RP-HPLC (25:65:10 AcN/water/1% TFA, 230 nm). Yield=490 mg of a white powder The terphenyl side chain was coupled to the above product according to the method for preparation of compound E2-10(b). Reacting amounts: 490 mg of the above compound, 260 mg (0.544 mmol) of the terphenyl active ester, 10 ml of dimethyl formamide, and enough diisopropylethylamine to make the reaction basic. The reaction was followed by RP-HPLC (25:65:10 AcN/water/1% TFA for starting material, 230 nm and 60:30:10 AcN/water/1% TFA for product, 280 nm). The solvent was removed under high vacuum to yield a white, gummy residue. Trituration from ether (2 washes) yielded 800 mg of a pale-yellow powder. The above product was subjected to the same hydrogenolysis conditions as that for compound E2-10(a). Reagent amounts: 400 mg of 10% palladium on charcoal, 100 ml of glacial acetic acid. Overnight reaction yielded 600 mg of an off-white solid. The product was isolated using RP-HPLC (AcN/water/1% TFA (50:40:10), 280 nm). Yield=188 mg of a white powder. NMR data was consistent with structure E2-12. MS(FAB)=1150.54 (exact mass) Preparation of the Product From Coupling Diaminopropionic Acid to Compound E2-7 (E2-13) Following the above procedure for the preparation of compound E2-12, the active ester of L-di-CBz-diamino-propionic acid was prepared. Reacting stoichiometries were: L-di-CBz-diaminopropionic acid—581 mg (1.56 mmol), pentafluorophenol—344 mg (1.87 mmol), 1-[3-(dimethylamino) propyl]-3-ethylcarbodiimide hydrochloride (EDAC)—360 mg (1.87 mmol), tetrahydrofuran—12 ml. TLC system:chloroform/methanol/glacial acetic acid, 75:25:drop, for starting material; 40% ethyl acetate/hexane, TDM stain for product. Same workup yielded 720 mg (86%) of a white solid. The material had satisfactory NMR data. Again, following the above procedure for coupling the active ester (710 mg, 1.32 mmol) to compound E2-7 (800 mg, 0.52 mmol) and refluxing for 2 days, standard workup yielded 1.1 g of a white foam. Flash silica gel column chromatography (100 g of silica, 20% ethyl acetate/hexane) yielded 0.56 g (57% yield) of a white foam. MS(FAB)=1891 (parent ion) The silyl and BOC protecting groups were removed following the previous procedure for preparation of compound E2-9. The reaction was monitored by RP-HPLC (50:40: 10 AcN/water/1% TFA, 230 nm). Yield=550 mg The terphenyl side chain was coupled to the above product according to the method for preparation of compound E2-10(b). Reacting amounts: 550 mg of the above compound, 239 mg (0.5 mmol) of the terphenyl active ester, 10 ml of dimethylformamide, and enough diisopropylethylamine to make the reaction basic. The reaction was followed by RP-HPLC (70:20:10 AcN/water/1% TFA for starting material, 230 nm and 40:50:10 AcN/water/1% TFA for product, 280 nm). The solvent was removed under high vacuum to yield a white, gummy residue. Trituration from ether (2 washes) yielded 850 mg of an off-white powder. The above product was subjected to the same hydrogenolysis conditions as that for compound E2-10(a). Reagent amounts: 400 mg of 10% palladium on charcoal, 100 ml of glacial acetic acid. Overnight reaction yielded 580 mg of an off-white solid. The product was isolated using RP-HPLC (gradient AcN/water/1% TFA (45/45/10→+55/10 elution scheme, 280 nm). Two separate products were isolated, both having the same molecular weight. It was never determined what the relative stereochemistries of the two compounds were. The yield of one E2-13 isomer was 76 mg and the yield of the other E2-13 isomer was 116 mg. MS(FAB)=1179.6 (parent ion) for both Table 2 summarizes the activity data for compounds E2-9 through E2-13 in comparison with the comparative semi-synthetic Echinocandin compound C1. The same testing procedures were used as described in Example 1 above. TABLE 2 Minimal Inhibitory Concentration (MIC) μg/ml Histoplasma Example No. C. albicans C. parapsilosis A. fumigatus capsulatum Comparative 0.01 0.156 0.02 0.01 C1 E2-10(a) 0.625 >20 0.625 5.0 E2-10(b) 0.01 0.156 0.156 0.156 E2-11(a) R = methyl 0.005 0.156 0.039 0.78 TFA salt E2-11(a) R = methyl 0.001 0.156 0.078 0.02 HCl salt E2-11(b) R = ethyl 0.001 0.156 0.312 0.02 HCl salt E2-11(c) R = n-propyl 0.312 1.25 0.156 0.312 HCl salt E2-12 0.01 0.312 0.156 0.039 E2-13 0.078 2.5 0.625 1.25 (isomer 1) E2-13 0.156 20 1.25 10 (isomer 2) Example 3 further illustrates the insertion of a new unit to yield an analog of an Echinocandin-type compound. Example 3 CbzNHCH 2 CH 2 SH was prepared as described in I. Shinkai, T. Liu, R. Reamer, M. Sletzinger, Synthesis , 924, 1980. N-BOC-O-toluenesulfonyl serine methyl ester was prepared as described in N. A. Sasaki, C. Hashimoto, P. A. Potier, Tetrahedron Lett ., 28, 6069-6072, 1987. Preparation o(R)-2-[(Tert-Butoxy-carbonyl)amino]-3-[(2′-N-benzyloxycarbonyl amino)ethanethio]methyl Propiolate (E3-1) Sodium hydride (72 mg, 1.8 mmol, 60% suspension in mineral oil) was triturated with hexanes under a nitrogen atmosphere in a 3-necked round bottomed flask. The flask was placed in a 0° C. bath and a solution of CbzNHCH 2 CH 2 SH (470 mg, 1.87 mmol, 85% pure) in DMF (5 ml) was added. The resulting mixture was stirred at 0° C. for 20 min which resulted in a colorless solution. N-BOC-O-toluenesulfonyl serine methyl ester (671 mg, 1.8 mmol) was added as a solid and washed into the flask with an additional 2 ml of DMF. The resulting mixture was stirred at 0° C. for 3 hours then poured into water and extracted twice with ethyl acetate. The combined organic extracts were washed with water, 1N sodium hydroxide solution, water, and brine, then dried over MgSO 4 and concentrated in vacuo to give 900 mg of an oil. Radial chromatography eluting with 25%→50% ethyl acetate in hexanes gave 570 mg 76% of the desired (R)-2-[(tert-Butoxy-carbonyl)amino]-3-[(2′-N-benzyloxycarbonyl amino)ethanethio]methyl propiolate. Anal. calculated for C 19 H 28 N 2 O 6 S, C: 55.32, H: 6.84, N: 6.79; Found C: 55.26, H: 6.95, N: 6.94. [α] D −1.9° (C=10). Preparation of (R)-2-[(Tert-Butoxycarbonyl)amino]-3-[(2′-N-benzyloxycarbonyl amino)ethanethio]propiolic Acid. (E3-2) Compound E3-1 (520 mg, 1.26 mmol)in dioxane (3 ml) was treated with 0.5M LiOH solution (3 ml) and stirred at room temperature overnight. The dioxane was removed in vacuo and the residue partitioned between 1N hydrochloric acid solution and ethyl acetate. The organic extract was washed with brine, dried over MgSO 4 and concentrated in vacuo to give 500 mg of a colorless oil corresponding to compound E3-2. Anal. calculated for C 18 H 26 N 2 O 6 S+0.4H 2 O, C: 53.29, H: 6.65, N: 6.90; Found C: 53.61, H: 6.82, N: 6.85. [α] D −0.9° (c=10). MS: (m+1) 399. Preparation of (R)-2-[(Tert-Butoxycarbonyl)amino]-3-[(2′-N-benzyloxycarbonyl amino)ethanesulfonyl]Propiolic Acid (E3-3) Compound E3-2(0.95g, 2.38 mmol) was dissolved in MeOH (15 ml) and cooled to 0° C. A solution of Oxone® (1.77g, 5.7 mmol) in water (15 ml) was added and the resulting mixture stirred at 0° C. for 1 hour then at room temperature overnight. The MeOH was removed in vacuo and the residue partitioned between ethyl acetate and water. The aqueous phase was extracted several more times with ethyl acetate. The combined organic extracts were washed with brine, dried over MgSO 4 and concentrated in vacuo to give 800 mg (78%) of a colorless foam corresponding to compound E3-3. Anal. calculated for C 18 H 26 N 2 O 8 S, C: 50.22, H: 6.09, N: 6.51. Found: , C: 50.13, H: 5.86, N: 6.45. [α] D −7° (c=10). MS: (m+1) 431. Preparation of Compound E3-4 To a solution of Compound E3-3(160 mg, 0.37 mmol) and N-hydroxysuccinimide (43 mg, 0.37 mmol) in dry THF (5 ml) was added dicyclohexylcarbodiimide (76 mg, 0.37 mmol) and an additional 2 ml of THF. The mixture was stirred at room temperature for 3 hours then cooled to 0° C. to help precipitate dicyclohexyl urea. In the meantime, the DiBOC CBZ silyl pentapeptide I-6(565 mg, 0.337 mmol) was dissolved in absolute ethanol (10 ml) and glacial acetic acid (95 ml), degassed and then 10% Pd/C (160 mg) was added to the mixture. The mixture was stirred under an atmosphere of H 2 (balloon pressure) for 3 hrs. The catalyst was removed by filtration and the filtrate concentrated in vacuo to a thick oil. THF (10ml) and acetic acid (1ml) were added and the solvents again removed in vacuo to remove all residual ethanol. The above prepared NHS active ester of compound E3-3 was filtered directly into the flask containing the deblocked pentapeptide through a sintered glass funnel, washing the precipitated DCU with an additional 3 ml of THF. The resulting solution was made basic to Litmus paper by dropwise addition of triethyl amine. The mixture was stirred at room temperature for an additional 3 hours, then diluted with ethyl acetate, washed with saturated sodium bicarbonate solution, and brine, then dried over MgSO 4 and concentrated in vacuo. Flash chromatography eluting with 7:2:1 hexane:ethyl acetate:methylene chloride gave the desired coupling product E3-4 as a mixture of isomers. The less polar isomer yielded 140 mg having a MS=1950.9(m+). Mixed fractions: 224 mg. The more polar isomer yielded 155 mg having a MS=1951.9 (m+1). Total yield 519 mg, 78%. This reaction was repeated on a 0.6 mmol scale to give 400 mg of the desired product as a mixture of isomers. Anal. calculated for C 93 H 168 N 8 O 22 SSi 6 , C: 57.25, H: 8.68, N: 5.75; Found C: 57.55, H: 8.63, N: 5.79. (The stereocenter of acid E3-3 racemized in the coupling reaction.) Preparation of Compound E3-5 A solution of compound E3-4 (390 mg, 0.2 mmol, mixture of diastereomers) in absolute ethanol (10 ml) and glacial acetic acid (10 ml) was degassed and then treated with 10% Pd/C (390 mg). The mixture was stirred under an atmosphere of H 2 (balloon pressure) for 2 hrs. The catalyst was removed by filtration through Celite and the filtrate concentrated in vacuo being careful to leave some acetic acid present. The residue was diluted with diethyl ether (175 ml) and triethylamine was added until the mixture was basic to Litmus paper (approximately 1 ml was required). The resulting solution was stirred at room temperature overnight, then washed with 0.1N hydrochloric acid solution, brine, dried over MgSO 4 , and concentrated in vacuo to give a foam. Flash chromatography on silica gel eluted with 30% ethyl acetate in hexanes gave the desired ring closed material E3-5. The less polar isomer yielded 105 mg of a foam having a MS: (m+) 1599.9. The more polar isomer yielded 110 mg of a foam having a MS=1599.8(m+). Total yield was 215 mg, 67%. Preparation of Compound E3-6 The more polar isomer of compound E3-5 (160 mg, 0.1 mmol) was dissolved in trifluoroacetic acid (5 ml) that had been cooled to 0° C. After 30 min water (0.5 ml) was added and the mixture stirred an additional 30 min at 0° C. The mixture was concentrated in vacuo, the residue dissolved in THF and concentrated in vacuo. The residue was dissolved in THF (3 ml), 1N hydrochloric acid solution (1 ml) was added, and the mixture placed in the refrigerator overnight. The solvent removed in vacuo then additional THF was added and the mixture reconcentrated to azeotrope off the water. This treatment provided a white solid. This white solid was dissolved in DMF(5 ml) and the terphenylhydroxybenzotriazole active ester (58 mg, 0.12 mmol) was added followed by triethylamine (60 □1, 0.4 mmol). The resulting solution was stirred at room temperature overnight, then the solvent was removed in vacuo. The residue was purified by preparative RP-HPLC (step gradient 50%-70% AcN in water over 45 min). The major peak was analyzed by HPLC (C-18 u-bondpak column, 60% AcN, 0.1% TFA in water) and the fractions containing the material which eluted at 4 min were combined and freeze dried to give 65 mg (56% yield) of E3-6 as a white powder having a MS 1156.6(m+). In analogous fashion the less polar isomer was converted to E3-7 (material eluted in 7 min under the above described analytical conditions) to give 13 mg (11% yield) of the desired E3-7. FAB MS (M), calculated for C 58 H 74 N 7 O 16 S 1156.4913; found=1156.4924. The following set of examples illustrate the further cleavage of the linear pentapeptide to a tetrapeptide and subsequent insertion of new units onto the linear peptide chain prior to closing. Example 4 To a solution of Compound I-7 (732 mg, 1.1 mmol) in anhydrous THF (25 ml) was added PyBOP® (572 mg, 1.1 mmol), N-Cbz-L-valine (304 mg, 1.21 mmol), diisopropylethyl amine (0.57 ml, 3.3 mmol), and anhydrous DMF (1.0 ml) to dissolve remaining solids. The solution was stirred at room temperature for 2 hrs. followed by removal of the solvents in vacuo. The residue was dissolved in anhydrous THF (40 ml), followed by addition of t-Butyldimethylsilylchloride (1.66 g, 11.0 mmol) and imidazole (750 mg, 11.0 mmol). The solution was stirred at room temperature for 18 hrs. The reaction was concentrated in vacuo and the residue was dissolved in Et 2 O, washed twice with 0.1N HCl, dried over MgSO 4 , and the solvent removed in vacuo. Flash chromatography (eluting with 35% EtOAc/hexane) gave 690 mg of product, 46% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E4-1. FAB MS (M+)=1356. To a solution of Compound E4-1 (700 mg, 0.51 mmol) in anhydrous THF (0.6 ml) and acetonitrile (4 ml) was added N-t-Boc anhydride (0.24 ml, 1.03 mmol) and dimethylaminopyridine (7 mg, 0.05 mmol). The solution was stirred for 3 hrs. Following removal of the solvents in vacuo, flash chromatography (eluting with 17% EtOAc/hexane) gave 307 mg of product, 38% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E4-2. FAB MS (M + of free base)=1556. To a solution of 5% Pd/C (150 mg) in EtOH (15 ml) and AcOH (15 ml) under an N 2 atmosphere was added Compound E4-2 (307 mg, 0.20 mmol). The solution was purged/filled with H 2 (×8) and subjected to constant H 2 pressure for 2.0 hrs., then filtered over Celite to remove the catalyst. The solution was concentrated in vacuo to remove solvents, the residue dissolved in anhydrous THF (30 ml), followed by addition of α-N-t-Boc-γ-N-Cbz-L-ornithine (80 mg, 0.22 mmol), PyBOP® (103 mg, 0.20 mmol), and diisopropylethyl amine (0.10 ml, 0.59 mmol). The reaction was stirred at room temperature for 18 hrs., followed by removal of the solvent in vacuo. Flash chromatography (eluting with 30% EtOAc/hexane) gave 284 mg of a white solid, 81% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E4-3. FAB MS (M + of free base)=1771. To an N 2 purged solution of Compound E4-3 (279 mg, 0.16 mmol) in EtOH (13 ml) and AcOH (12 ml) was added 5% Pd/C (150 mg). The reaction was purged/filled with H 2 (×10) and left under constant H 2 pressure for 2 hrs., followed by removal of the catalyst by filtration over Celite and removal of solvents in vacuo. The resulting oil was dissolved in Et 2 O (75 ml) followed by addition of triethylamine (5 ml, 35.9 mmol). After 18 hrs., the reaction was concentrated in vacuo, and flash chromatography (eluting with 34% EtOAc/hexane) gave 96 mg of product, 43% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E4-4. FAB MS (M + of free base)=1420. A solution of Compound E4-4 (93 mg, 0.07 mmol) in ice cold TFA (2 ml) was placed in a 0° C. freezer for 2 hrs., followed by addition of ice cold water (2 ml) and was then stirred in an ice bath for 2 hrs. The solution was concentrated in vacuo to yield 66 mg white solids, which were dissolved in THF (1.5 ml) and HCl (1.5 ml, 1.0N) and stirred at room temperature for 16 hrs. Toluene was added and the solution was concentrated in vacuo three times to assist in removal of TFA, giving 44.5 mg of an off-white solid, 91% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E4-5. FAB MS (M + of free base)=748. To a solution of Compound E4-5 (44 mg, 0.06 mmol) in anhydrous DMF (2 ml), was added diisopropylethyl amine (0.03 ml, 0.18 mmol) and the hydroxybenzotriazole active ester of the terphenyl side chain (34 mg, 0.07 mmol). The solution was stirred at room temperature for 40 hrs. Solvent was removed in vacuo and the residue was treated with Et 2 O (10 ml), sonicated, and a brown solid was isolated by filtration. RP-HPLC (eluting with 30-70% ACN/0.1% TFA/H 2 O) and freeze drying gave 18.7 mg of a white solid, 29% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E4-6. FAB MS (M + of free base)=1090. Example 5 Example 5 further exemplifies the insertion of new units onto a tetrapeptide chain followed by ring closure to produce a new cyclic peptide Echinocandin-type structure. To a solution of tetrapeptide I-7 (700 mg, 1.05 mmol) in anhydrous THF (20 ml) was added PyBOP® (547 mg, 1.05 mmol), N-Cbz-L-tyrosine (364 mg, 1.16 mmol), N,N-diisopropylethylamine (0.55 ml, 3.15 mmol). The solution was stirred at room temperature for 3 hrs. followed by removal of the solvents in vacuo. Used directly in the next reaction. The above residue E5-1 was dissolved in anhydrous DMF (10 ml), followed by addition of t-Bu-dimethylsilyl chloride (1.90 g, 12.6 mmol) and imidazole (860 mg, 12.6 mmol) and the solution was stirred at room temperature for 18 hrs. The reaction was concentrated in vacuo and the residue was dissolved in Et 2 O, washed twice with cold 0.1N HCl, once with H 2 O, 10% aq. sodium bicarbonate, brine and dried over MgSO 4 , filtered and the solvent removed in vacuo to give 2.0 g crude oil. Purified by radial chromatography (eluting with 35% EtOAc/hexanes) to give 700 mg (43% yield) of product. The 1 H NMR (300 MHz) spectrum was consistent with the structure E5-2. FAB MS (M + )=1534. To a solution of Compound E5-2 (700 mg, 0.46 mmol) in anhydrous THF (10 ml) was added N-t-Boc anhydride (0.41 ml, 1.78 mmol) in portions and dimethylaminopyridine (7 mg, 0.05 mmol), and the solution was stirred for 3 hrs. at ambient temperature. Following removal of solvents in vacuo, purification by radial chromatography (eluting with 20% EtOAc/hexanes) gave 460 mg of product, 58% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E5-3. FAB MS (M + of free base)=1735. To a solution of 10% Pd/C (270 mg) in EtOH (10 ml) and AcOH (10 ml) under an N 2 atmosphere was added Compound E5-3 (460 mg, 0.27 mmol). The solution was purged/filled with H 2 (×4) and subjected to constant H 2 pressure for 2.0 hrs. at ambient temperature, then filtered over Celite to remove catalyst. The solution was concentrated in vacuo to remove solvents, the residue dissolved in anhydrous THF (30 ml), followed by addition of α-N-t-Boc-γ-N-Cbz-L-ornithine-N-hydroxysuccinimide ester (172 mg, 0.37 mmol), and triethylamine to pH 8(≈5 ml). The reaction was stirred at room temperature for 3 hrs. Diluted the reaction with ether and washed with saturated sodium bicarbonate, 0.1N HCl, saturated sodium bicarbonate, and dried over magnesium sulfate. Filtered and concentrated in vacuo. Radial chromatography (eluting with 30% EtOAc/hexanes) gave 280 mg of a white solid, 54% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E5-4. FAB MS (M + of free base)=1949. To an N 2 purged solution of Compound E5-4 (280 mg, 0.14 mmol) in EtOH (10 ml) and AcOH (5 ml) was added 10% Pd/C (200 mg). The reaction was purged/filled with H 2 (×4) and left under constant H 2 pressure for 2 hrs., followed by removal of the catalyst by filtration over Celite. The resulting oil was dissolved in Et 2 O (10 ml) followed by addition of triethylamine (4 ml, 28.7 mmol). After 18 hrs., the reaction was concentrated in vacuo, and purified by radial chromatography (eluting with 40% EtOAc/hexanes) gave 130 mg of product, 57% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E5-5. FAB MS (M + of free base)=1597. A solution of Compound E5-5 (128 mg, 0.08 mmol) in ice cold TFA (2 ml) was placed in 0° C. freezer for 2 hrs., followed by addition of ice cold water (2 ml) and was then stirred in an ice bath for 2 hrs. The solution was concentrated in vacuo, then dissolved in THF (1.5 ml) and 1N HCl (1.5 ml) and stirred at room temperature for 16 hrs. Toluene was added and the solution was concentrated in vacuo three times, giving 70 mg of a dihydrochloride white solid, 100% yield. The 1 H NMR (300 MHz) spectnun was consistent with the structure E5-6. FAB MS calculated for M+H C 39 H 54 N 7 O 12 =812.3830; found=812.3837. To a solution of Compound E5-6 (65 mg, 0.08 mmol) in anhydrous DMF (5 ml), was added N,N-diisopropylethylamine (2.0 ml, 11.5 mmol) and the hydroxybenzotriazole active ester of the terphenyl side chain (50 mg, 0.11 mmol), and the solution was stirred at room temperature for 18 hrs. Solvent was removed in vacuo and the residue was treated with Et 2 O (10 ml), sonicated, and a beige solid was isolated. The methanol soluble portion was purified by RP HPLC (Waters Bondapak C-18, eluting with 58% AcN/0.1% TFA/H 2 O at a flow of 20 ml/min) and freeze drying gave 35 mg of a white solid, 38% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E5-7. FAB MS calculated for M+H C 63 H 76 N 7 O 14 =1154.5450; found=1154.5458. Example 6 illustrates the introduction of a water solubilizing group onto the tetrapeptide intermediate prior to cyclization. Example 6 N-α-Boc-L-α,β-diaminopropionic acid (0.5 g, 2.45 mmol)(available from Bachem) and 1,3-Bis(benzyloxycarbonyl)-2-methyl-2-thiopseudourea (0.88 g, 2.45 mmol) were combined in 15 ml of anhydrous DMF. Triethylamine (1.0 ml, 7.3 mmol) was added and stirred for 3 days at ambient temperature. The reaction was diluted with 100 ml of 0.1 N NaOH and extracted into ether. The aqueous layer was then acidified with cold saturated citric acid and extracted with ethyl acetate (3×200 ml). The combined organics were dried over MgSO 4 , filtered and concentrated to a quantitative yield of a thick colorless oil. The 1 H NMR (300 MHz) spectrum was consistent with structure E6-1. FD MS (M + of free base)=515. To the above acid E6-1 (310 mg, 0.60 mmol) in anhydrous THF (10 ml) was added N-hydroxysuccinimide (69 mg, 0.60 mmol) and DCC (123 mg, 0.60 mmol). A white precipitate began to form after about 1 hr. The reaction was allowed to stir overnight at ambient temperature. The reaction was filtered and the crude solution used directly in the next coupling. To a solution of the above activated ester E6-2 (366 mg, 0.60 mmol) in anhydrous THF (10 ml) and ether (10 ml) was added Compound E5-3(920 mg, 0.60 mmol) and triethylarnine (3 ml). The solution was allowed to stir overnight (18 hrs.) at ambient temperature. The reaction was diluted with ether and washed with saturated sodium bicarbonate (1×250 ml), 0.1 N HCl (1×250 ml), saturated sodium bicarbonate (1×250 ml), dried over magnesium sulfate, filtered and concentrated to 1.0 g crude white solid. The product was purified by radial chromatography (eluting with 30/70 ethyl acetate/hexanes) to give 550 mg (46% yield) of a white solid. The 1 H NMR (300 MHz) spectrum was consistent with structure E6-3. FAB MS (M + of free base)=2036. To a solution of 5% Pd/C (150 mg) in EtOH (15 ml) and AcOH (15 ml) under an N 2 atmosphere was added Compound E6-3 (550 mg, 0.27 mmol). The solution was purged/filled with H 2 (×4) and subjected to constant H 2 pressure for 2.0 hrs., then filtered over Celite to remove the catalyst. The solution was concentrated in vacuo to remove the solvents, the residue dissolved in acetonitrile (10 ml) and ether (3 ml), followed by addition of 2 ml of triethylamine. The mixture was sonicated for 4 hours and the temperature allowed to reach 40° C. The reaction mixture was concentrated and purified by radial chromatography (eluting with 40/60 ethyl acetate/hexanes) to give 57 mg of the desired compound (14% yield). The 1 H NMR (300 MHz) spectrum was consistent with the structure E6-4. FAB MS (M + of free base)=1549. To the above compound E6-4 (77 mg, 0.05 mmol) was added 3 ml of neat trifluoroacetic acid while cooling to 0° C. After 45 minutes, 0.5 ml of water was added while maintaining the reaction at 0° C. After 30 minutes, the mixture was concentrated to a colorless oil. To this oil was added 2 ml of THF and 2 ml of 1N HCl and refrigerated overnight. Toluene was stripped from the mixture to give a quantitative yield of the free amine as the trihydrochloride salt. The 1 H NMR (300 MHz) spectrum was consistent with the structure E6-5. FAB MS (M + of free base)=764. To a solution of Compound E6-5 (50 mg, 0.06 mmol) in anhydrous DMF (5 ml), was added N,N-diisopropylethylamine (2 ml) and the hydroxybenzotriazole active ester of the terphenyl side chain (44 mg, 0.09 mmol), and the solution was stirred at room temperature for 18 hrs. The solvent was removed in vacuo and the residue was triturated with a mixture of acetonitrile and ether. The solid was dried to 25 mg of a crude white solid. The product was purified by RP HPLC on a Waters Bondapak C-18 column eluting with 55% AcN/0.1% TFA/H 2 O at a flow of 20 ml/min. The appropriate fractions were freeze dried to give 10.0 mg of a white solid, 18% yield. The 1 H NMR (300 MHz) spectrum was consistent with the structure E6-6. FAB MS calculated for (M+H) C 57 H 72 N 9 O 14 =1106.5199; found=1106.5185 Table 3 summarizes the activity data for compounds E3-6, E4-6, E5-7 and E6-6 in comparison with the comparative semi-synthetic Echinocandin compound C1. The same testing procedures were used as described in Example 1 above. TABLE 3 Minimal Inhibitory Concentration (MIC) μg/ml Histoplasma Example No. C. albicans C. parapsilosis A. fumigatus capsulatum Comparative 0.01 0.156 0.02 0.01 C1 E3-6 10 >20 20 10 E3-7 >20 >20 >20 >20 E4-6 1.25 >20 >20 >20 E5-7 >20 >20 >20 >20 E6-6 0.078 >20 >20 >20 Example 7 Example 7 illustrates the formation of a cyclic heptapeptide from the intermediate linear pentapeptide (I-6). Preparation of N-α-BOC-D-2,3-diaminopropionic Acid (E7-1) To a 1:1 dimethylformamide:water solution (170 ml) of [bis(trifluoroacetoxy)iodo]benzene (12.89 g, 32.29 mmol, 1.5 equiv) was added N-α-BOC-D-asparagine (5 g, 21.53 mmol, 1 equiv). This solution stirred at room temperature for 0.5 h before pyridine (3.4 g, 43.06 mmol, 2 equiv) was added. After 18 h the reaction was concentrated in vacuo and the residue was redissolved in water before being washed with diethyl ether (2×, 50 ml). The aqueous layer was concentrated in vacuo and the crude product was recrystallized from hot acetonitrile to give E7-1 (1.10 g, 25% yield). Preparation of N-α-BOC-D-2,3-diaminopropionic Acid-N-CBZ-glycine Dipeptide (E7-2) An aqueous solution (12 ml) of N-α-BOC-D-2,3-diaminopropionic acid E7-1 (1.114 g, 5.45 mmol, 1 equiv) and NaHCO 3 (0.458 g, 5.45 mmol, 1 equiv) was stirred rapidly for 15 minutes until complete solvation. To this was added a 1,2-dimethoxyethane solution (22 ml) of N-CBZ-O-N-hydroxysuccinimide glycine ester. After stirring at room temperature for 18 hours the reaction was concentrated in vacuo. The residue was redissolved in water, acidified to pH 3 with 1N aqueous HCl, and partitioned between ethyl acetate and water. The aqueous layer was washed 3× with additional water before organics were combined, dried over MgSO 4 , and concentrated. The crude white foam was purified on reverse phase, C-18 column, preparative HPLC (gradient 5:95 AcN/0.01% TFA to 100% AcN elution scheme) to afford 1.46 g (3.69 mmol, 68% yield) of E7-2. Preparation of N-α-BOC-D-2,3-diaminopropionic Acid-N-CBZ-glycine Dipeptide-O-NHS Active Ester (E7-3) To a 1,2-dimethoxyethane solution (40 ml) of E7-2 (1.40 g, 3.54 mmol, 1 equiv) and N-hydroxysuccinimide (0.448 g, 3.89 mmol, 1.1 equiv) cooled to 0° C. was added dicyclohexylcarbodiimide (0.804 g, 3.89 mmol, 1.1 equiv). After stirring for 1 h at 0° C. it was set in the refrigerator for 18 hours. The solution was then filtered and the filtrate was stripped to dryness and placed on high vacuum for 2 hours to give approximately 2 g of product (contained some DCU byproduct) which was used without further purification. DiBOC Silyl N(α)BOC-D-2,3-diaminopropionic Acid-Glycine-CBZ Heptapeptide (E7-4) A solution of linear peptide intermediate I-6 (1.0 g, 0.598 mmol) in ethanol (5 ml) was added to a slurry of 10% Pd/C (250 mg) in 5 ml of ethanol followed by 10 ml of glacial acetic acid. The mixture was put under a balloon of H 2 and after 1 hr the starting material was gone (TLC 25% ethyl acetate/hexane). The catalyst was removed by filtration through a Celite plug and the solution was carefully reduced (but not to dryness) under high vacuum keeping the temperature under 40° C. The resulting oil was dissolved in 25 ml of ether and a 10 ml tetrahydrofuran solution of dipeptide active ester E7-3 (O-Suc-Nα-BOC-D-2,3-diaminopropionic acid-N-CBZ-glycine) was added followed by excess triethylamine until the solution was basic to pH paper. After stirring for 16 hrs., the solution was extracted with saturated NaHCO 3 solution followed by dilute HCl solution and then another portion of saturated NaHCO 3 solution. The organic layer was dried over MgSO 4 and reduced in vacuo to give 1.194 g of the crude product. Purification by flash chromatography (30% ethyl acetate/hexane) gave 0.674 g (59% yield) of coupled product E7-4. FAB MS=1916.5 (M+1) Cyclization of E7-4 to BOC Silyl Cycloheptapeptide (E7-5) An ethanol/acetic acid solution (10 ml of each) of E7-4 (0.665 g, 0.34 mmol) with 10% Pd/C (200 mg) was placed under a balloon of hydrogen. After 1.5 hrs., TLC (30% ethyl acetate/hexane) indicated a complete reaction. The catalyst was removed by filtration through a plug of Celite and the solvent reduced in vacuo (but not to dryness) at 40° C. until the residue was a thick oil. This material was dissolved in ethyl ether (150 ml) and excess triethylamine (˜8 ml) was added. After 18 hrs., TLC (30% ethyl acetate/hexane) indicated one major product spot. The solvent was removed in vacuo and the residue was redissolved in ethyl acetate and washed several times with water. The organics were combined and dried over MgSO 4 and the solvent removed in vacuo to give 0.800 g of crude product. This was purified over a flash column (silica gel eluted with 30% ethylacetate/hexanes) to provide 293 mg (54% yield) of E7-5 as a white solid. FAB MS=1564.9 Removal of Protecting Groups and Coupling of the Side Chain to Give E7-6 Compound E7-5 (288 mg, 0.181 mmol) was dissolved in trifluoroacetic acid (3 ml) and cooled to 0° C. After 0.5 hrs., water was added (0.5 ml) and the mixture was stirred for 0.6 hrs longer. The solvent was removed in vacuo and the residue was dissolved in 1N HCl (2 ml) and tetrahydrofuran (3 ml). This solution was stirred at room temperature for 1.5 hr after which time it was set in the refrigerator overnight. The solvent was removed under high vacuum giving a foam residue which was dissolved in anhydrous dimethylformamide (3 ml). Terphenyl hydroxybenzotriazole active ester (108 mg, 0.276 mmol) and triethylamine (0.11 ml, 0.78 mmol) were added to the solution. After stirring overnight at room temperature the solvents were removed under high vacuum and the crude material (380 mg) was purified by preparative RP-HPLC (C-18 column eluted with a 50% AcN/0.01% TFA aqueous solution). Lyophilization of the pure fractions gave 97 mg (48% yield) of E7-6(a) as a white solid. FAB MS=1121.5 (M) calc. for C 58 H 72 N 8 O 15 =1121.21 Preparation of E7-6(b) In a similar manner, N-α-BOC-L-asparagine was converted to E7-6(b). The H-NMR data was consistent with the structure E7-6(b). MS(FAB)=1121 (M+) Preparation of N-α-CBZ-D-2,3-diaminopropionic Acid (E7-7) Compound E7-7 was prepared in a similar manner to N-α-BOC-diamino propionic acid E7-1. MS FAB (M+1)=239 Preparation of N-α-CBZ-N-β-BOC-D-2,3-diaminopropionic Acid (E7-8) To a stirring solution of sodium hydroxide (148 mg, 3.69 mmol, 1.1 equiv) in water (5 ml) was added N-α-CBZ-diamino propionic acid E7-7. The reaction was stirred for 10 minutes before tert-butyl alcohol (4 ml) was added. The reaction was cooled to 0° C. and di-tert-butyl dicarbonate (807 mg, 3.69 mmol, 1.1 equiv) was added slowly over 0.5 h. After stirring overnight at room temperature, the reaction was diluted with water (5 ml) and washed 3× with 10 ml ethyl ether. The organics were then combined and washed several times with saturated aqueous sodium bicarbonate. The aqueous layers were combined, cooled to 0° C., and acidified to pH 3 with aqueous potassium hydrogen sulfate (30 g in 200 ml stock solution). This cloudy solution was then extracted several times with ethyl acetate. The organics were combined, dried over MgSO 4 , and concentrated in vacuo to give after overnight high vacuum 0.990 g (2.9 mmol, 87% yield) of E7-8. The 1 H NMR was consistent with structure E7-8. MS FAB (M+1)=339 Preparation of N-β-BOC-D-2,3-diaminopropionic Acid (E7-9) To an ethyl alcohol solution (20 ml) of N-α-CBZ-N-β-BOC-D-2,3-diaminopropionic acid E7-8 was added 10% palladium on carbon catalyst (approx. 200 mg). The mixture was placed under an H 2 atmosphere and stirred vigorously. Due to gel like formation, the reaction required additional ethyl alcohol (total volume of 75 ml) to facilitate easy stirring. After several hours, the reaction was filtered through a plug of Celite and then concentrated in vacuo to give 259 mg (1.27 mmol, 32% yield) of E7-9. Preparation of N-β-BOC-D-2,3-diaminopropionic Acid-N-CBZ-glycine Dipeptide (E7-10) Compound E7-10 was prepared in a similar manner as N-α-BOC-D-2,3-diaminopropionic Acid-N-CBZ-glycine Dipeptide E7-2. The 1 H NMR was consistent with the structure E7-10. Preparation of N-β-BOC-D-2,3-diaminopropionic Acid-N-CBZ-glycine Dipeptide-O-NHS Active Ester (E7-11) Compound E7-11 was prepared in a similar manner as N-α-BOC-D-2,3-diaminopropionic acid-N-CBZ-glycine dipeptide-O-NHS active ester E7-3. Preparation of DiBOC Silyl N(β)BOC-D-2,3-diaminopropionic Acid-glycine-CBZ Heptapeptide (E7-12) Compound E7-12 was prepared in a similar manner as DiBOC silyl N(α)BOC-D-2,3-diaminopropionic acid-glycine-CBZ heptapeptide E7-4. MS FAB (M+1)=1917 Preparation of BOC Silyl Cycloheptapeptide (E7-13) Compound E7-13 was prepared in a similar manner as BOC silyl cycloheptapeptide E7-5. Preparation of Cycloheptapeptide E7-14(a) Compound E7-14 was prepared in a similar manner as cycloheptapeptide E7-6. MS FAB (M)=1121.6 Preparation of Cycloheptapeptide E7-14(b) In a similar manner as E7-14(a), E7-14(b) was prepared from N-α-CBZ-L-2,3-diamino propionic acid. The H 1 -NMR data was consistent with structure E7-14(b). MS(FAB)=1121 (M+) Example 8 Preparation of (-L-)-(α)-N-CBZ-(β)-N-trifluoroacetyl 2,3-Diaminopropionic Acid (E8-1) The procedure of Curphey et al., J. Org. Chem ., 44, 2805, (1979) was utilized as follows. A suspension of (-L)-(α)-N-CBZ-2,3-diaminopropionic acid (2.0 g, 8.39 mmol) and triethylamine (0.84 g, 8.39 mmol) in methanol (10 ml) at ambient temperature was treated with ethyl trifluoroacetate (1.49 g, 10.49 mmol) and the mixture stirred for 48 hrs. The resulting solution was diluted with methanol (5 ml), cooled to 0° C., and treated with Dowex 50W resin(3.30 g). After stirring for 10 min., the suspension was filtered and the filtrate concentrated in vacuo to produce 2.74 g of a white solid (98% yield) that was used without further purification. H 1 NMR data was consistent with the structure E8-1. MS(FD)=334 (M+) Preparation of the N-hydroxysuccinimide Ester (E8-2) From E8-1 To a solution of E8-1 (1.20 g, 3.59 mmol) and N-hydroxysuccinimide (0.45 g, 3.95 mmol) in 1,2-dimethoxyethane (20 ml) at 0° C. was added N,N′-dicyclohexylcarbodiimide (0.81 g, 3.95 mmol). The mixture was stirred at cold bath temperature for 2 hr followed by overnight storage in the refrigerator. Filtration of the suspension and subsequent concentration of the filtrate gave a crude solid product which was recrystallized from ethyl acetate/hexanes to produce 0.78 g of a crystalline solid (50% yield, one crop). The H 1 NMR data was consistent with structure E8-2. MS(FD)=431 (M+) Preparation of Dipeptide (E8-3) From Amino Acid Active Ester E8-2 (-L-)-(α)-N-BOC-2,3-diaminopropionic acid (0.52 g, 2.55 mmol) was dissolved in aqueous sodium bicarbonate solution (prepared from dissolving 0.22 g, 2.55 mmol of sodium bicarbonate in 10 ml of water). This solution was added to a solution of active ester E8-2 (1.1 g, 2.55 mmol) in 1,2-dimethoxyethane (23 ml) and the mixture stirred for 24 hrs. After concentration in vacuo to remove 1,2-dimethoxyethane, the residual suspension was adjusted to pH 5 with 1N aqueous citric acid, then extracted with ethyl acetate (2x). The combined organic extracts were washed successively with water and brine, dried over MgSO 4 and reduced in vacuo to give 1.4 g of a crude foam. Trituration with methylene chloride gave 1.05 g of a flocculent solid (75% yield). Additional product in mother liquor was not recovered. H 1 HMR data was consistent with structure E8-3. MS(negative ion electrospray)=519 (M-H) Preparation of Dipeptide Active Ester (E8-4) From Dipeptide E8-3 To a solution of E8-3 (0.65 g, 1.24 mmol) and N-hydroxysuccinimide (0.16 g, 1.37 mmol) in tetrahydrofuran (5 ml) at 0° C. was added N,N′-dicyclohexylcarbodiimide (0.28 g, 1.37 mmol). The mixture was stirred at cold bath temperature for 2 hrs followed by overnight storage in the refrigerator. Filtration of the suspension and subsequent concentration of the filtrate gave 0.70 g of a crude foam (89% yield). H 1 NMR data was consistent with structure E8-4. MS(FD)=631 (M+) Preparation of DiBOC Silyl (-L-)-(α)-N-BOC-2,3-diaminopropionic Acid-(-L-)-(α)-N-CBZ-(β)-N-trifluoroacetyl 2,3-diaminopropionic Acid Linear Heptapeptide (E8-5) A solution of linear pentapeptide intermediate I-6 (2.0 g, 1.19 mmol) in ethyl acetate(10 ml) was added to a slurry of 10% Pd/C (400 mg) in ethyl acetate (15 ml) followed by 20 ml of glacial acetic acid. The mixture was put under a balloon of H 2 and after 1 hr the starting material was gone. The catalyst was removed by filtration and the solution was carefully reduced under high vacuum keeping the temperature under 40° C. The resulting oil was dissolved in THF (15 ml) and the dipeptide active ester, N-(-L-)-(α)-CBZ-N-(β)-trifluoroacetyl 2,3-diaminopropionic acid-N-(L)-(α)-BOC-2,3-diaminopropionic acid-Osu E8-4, was added followed by excess triethylamine until the solution was basic to pH paper. After stirring for 18 hrs., the solution was reduced in vacuo and the residue partitioned between ethyl ether and water. The ether layer was washed with saturated NaHCO 3 solution, followed by successive washings with water, 1N aqueous citric acid, water, saturated NaHCO 3 and brine. The organic layer was dried over MgSO 4 and reduced in vacuo to give 2.36 g of the crude product. Purification by silica flash chromatography (25% ethyl acetate/hexane) gave 1.22 g of coupled product E8-5 as a foam (56% yield). H 1 NMR data was consistent with structure E8-5. MS(FAB)=2041.5 (M+) Cyclization of E8-5 to BOC Silyl Cycloheptapeptide (E8-6) An ethyl acetate/acetic acid solution (20 ml each) of E8-5 (1.20 g, 0.58 mmol) with 10% Pd/C (290 mg) was placed under a balloon of hydrogen. After 1.5 hrs., TLC indicated deprotection was complete. The catalyst was removed by filtration and the filtrate concentrated in vacuo to a thick slurry. This material was dissolved in ethyl ether(120 ml) and excess triethylamine was added until the solution was basic to pH paper(˜5 ml). After 36 hrs., TLC indicated one major product. The solution was washed successively with water, 1N aqueous citric acid, water, and brine. The organic layer was dried over MgSO 4 and reduced in vacuo to give 1.14 g of crude product. Purification by silica flash chromatography (25% ethyl acetate/hexane) gave 0.69 g of E8-6 as a foam (70% yield). H 1 NMR data was consistent with structure E8-6. MS(FAB)=1690.0(M+H) Removal of Protecting Groups and Coupling of the Side Chain to Generate E8-7 A solution of E8-6 (0.69 g, 0.40 mmol) in trifluoroacetic acid (23 ml) at 0° C. was stirred for 0.5 hr after which time water (2 ml) was added and the stirring continued for an additional 0.75 hr at 0° C. The solvent was removed in vacuo and the residue was dissolved in tetrahydrofuran (9 ml) and treated with 1N HCl (4 ml). This solution was stirred at ambient temperature for 1.25 hr and then refrigerated for 18 hr. HPLC showed one major product peak. Concentration in vacuo produced a residual foam which after dissolution in dimethylformamide (12 ml) was treated with the terphenyl hydroxybenzotriazole active ester (0.25 g, 0.52 mmol) and triethylamine (0.28 ml, 2.0 mmol). After stirring at ambient temperature for 17 hrs., the solvent was removed under high vacuum and the crude residue purified by preparative RP-HPLC (linear gradient 60%-100% AcN/0.1% TFA elution scheme) to produce 0.37 g of a white solid (75% yield). H 1 NMR data was consistent with structure E8-7. MS(FAB)=1246.7(M+) Final Deprotection of E8-7 to Generate E8-8 To a solution of E8-7 (250 mg, 0.20 mmol) in methanol (12 ml) was added a solution of potassium carbonate (138 mg, 1.0 mmol) in water (6 ml), and the resulting mixture stirred at ambient temperature for 20 hrs. Solvent removal in vacuo followed by purification via preparative RP-HPLC (linear gradient 60-100% AcN/0.1% TFA elution scheme) gave 218 mg of a white solid (94% yield). H 1 NMR data was consistent with structure E8-8. MS(FAB)=1150.6(M+) Reductive Alkylation of E8-8 to Generate E8-9 To a solution of E8-8 (40 mg, 0.0347 mmol) in methanol (2 ml) at ambient temperature was added 1-methyl-4-piperidone (7.85 mg, 0.0694 mmol) and glacial acetic acid (2 μl, 0.0347 mmol). The solution was treated with sodium cyanoborohydride (3.27 mg, 0.0520 mmol) and the mixture stirred for 16 hrs. After concentration in vacuo, the crude product was purified via preparative RP-HPLC (step gradient 40-100% AcN/0.1% TFA elution scheme) to yield 19 mg of a white solid (45% yield). H 1 NMR data was consistent with structure E8-9. MS(FAB)=1247.6 (M+) Table 4 summarizes the activity data for compounds E7-6(a), E7-6(b), E7-14(a), E7-14(b), E8-8 and E8-9 in comparison with comparative semi-synthetic Echinocandin compound C1 and Amphotericin B. The same testing procedures were used as described in Example 1 above. TABLE 4 Minimal Inhibitory Concentration (MIC) μg/ml Can - Histo - dida Asper - Crypto - plasma Candida para - gillus coccus capsu - Example No. albicans psilosis fumigatus neoformans latum Comparative 0.01 0.156 0.02 >20 0.01 C1 Ampho B 0.078 0.038 0.312 0.039 0.039 E7-6(a) >20 >20 >20 >20 >20 (22 membered ring) E7-6(b) 0.312 >20 5.0 >20 1.25 (22 membered ring) E7-14(a) 0.312 >20 >20 >20 0.312 (21 membered ring) E7-14(b) 0.156 >20 >20 >20 0.078 (21 membered ring) E8-8 0.078 0.625 5.0 >20 0.312 (22 membered ring) E8-9 0.156 5.0 5.0 >20 0.625 (22 membered ring)

1a

RELATED APPLICATIONS This application claims priority under 35, U.S.C. 119(e) from Provisional Application Ser. No. 60/659,220 filed Mar. 7, 2005. TECHNICAL FIELD [0001] The present invention is in the area of gun holsters. More specifically, it is in the area of concealed carry holsters made from elastic and inelastic textile components. BACKGROUND OF THE INVENTION [0002] Shortly after the invention of the first weapon, a hands free carrying means was invented. With the evolution of weapons from rocks and sticks to today's weaponry, the need for hands free carry has remained. A good hands free weapon carrying apparatus has a few basic requirements. It must positively hold the weapon so the weapon does not fall to the ground and so the weapon consistently remains in the same position. A consistent position is required whenever a weapon must be presented quickly. Losing time while locating a weapon can be fatal. Another requirement is comfort. A weapon that can't be carried comfortably is often left behind. An absent weapon can never be presented quickly. [0003] Cloth bands have often been used to carry weapons. For example, handguns have been carried by thrusting them between the body and a trousers waistband. Another example is the body band. A body band is a cloth band wrapped around the body into which weapons can be tucked. Some body bands are made from elastic materials. The problem with body bands is that they do not hold weapons in a positive manner. The weapon is free to shift positions and occasionally fall. [0004] Holsters are used to positively hold weapons. A weapon can be placed into a holster and the holster can be strapped to the body. Some holsters are designed for concealed carry. For example, paddle holsters are adapted for tucking inside a trousers waistband. Other concealed carry holsters are held to the body by a strap arrangement that encircles the body and at least one shoulder. The reason that at least one shoulder is encircled is that otherwise the weight of the weapon will pull the strap arrangement down the torso. [0005] Another problem with strap arrangements is that they must be carefully fit to each individual user. If not properly fit, the straps are more uncomfortable than usual and the weapon is often not positively held. Therefore, the strap arrangement must be individually tailored, which is expensive, or must be adjustable, which is less expensive. [0006] An adjustable strap arrangement requires many adjustment points because of the number of straps and the complexity of the strap arrangement itself. More recent adjustment points use hook and loop type fasteners such as those discussed in U.S. Pat. No. 2,717,437 and U.S. Pat. No. 3,009,235. The adjustment points add to the discomfort. [0007] Comfortable slip resistant materials have been used to keep bandages and wraps from slipping or shifting. One example of is a fabric with a tacky rubberized surface that is used to keep large bandages from shifting. Light pressure on the material is enough to keep it securely in place. Furthermore it is quite comfortable. Comfortable slip resistant material can be found outside the medical setting. For example, the “Rug Saver Nonslip Rug Pad” and the “Miracle Hold Rug Pad” can be used as comfortable slip resistant material. [0008] An inexpensive and comfortable concealed carry apparatus that positively holds a weapon to the body is needed. BRIEF SUMMARY OF THE INVENTION [0009] The present invention directly addresses the shortcomings of the prior art by using a comfortably wide band with a holster, an elastic strap, easy adjustment and a comfortable slip resistant material to keep the holster from shifting. [0010] In accordance with an aspect of the embodiment, a band is formed from an elastic strap and two end sections. The end sections are adapted for fastening together so that the band makes a single loop around the body or a body extremity. The band fits snugly because the elastic strap is lightly stretched when the band is in place. The end sections can be fastened together by buckling, pinning, gluing, or sewing. Hook and loop fasteners can also can fasten the end sections together. [0011] In accordance with another aspect of the embodiment, fastening the elastic strap with another piece of elastic material along seams forms a pocket assembly. The seams and the elastic pieces form a gun holstering pocket and a magazine holstering pocket. A magazine is an apparatus for holding cartridges for a semiautomatic gun and the magazine pocket is formed such that when the band is worn, the magazine holstering pocket is in front of the gun holstering pocket. The seams can be formed via gluing, sewing, or heat welding. A convenient way to form the pocket assembly is to fold the elastic strap back onto itself and fasten the two sections of elastic strap. [0012] In accordance with yet another aspect of the embodiment, comfortable slip resistant material is fixed to the band in opposition of the pocket assembly. In opposition means that if the band is laid flat with the pocket assembly facing up, then the slip resistant material is on the under side of the band and under the pocket assembly. The comfortable slip resistant material can be fastened to the band via sewing, gluing, hook and loop, or similar techniques. The comfortable slip resistant material can also be sprayed or spread onto the band. [0013] In accordance with yet another aspect of the embodiment, a hole in the gun holstering pocket enables easy access to the gun trigger. Quickly discharging a gun can be helpful in certain tactical settings because of the shock value of the sound. A trigger access hole allows the user to fire a gun without taking the time to remove the weapon from the holster. [0014] In accordance with yet another aspect of the embodiment, a holster liner is fixed to the inside of the gun holstering pocket. Guns often have sharp edges that can cut through elastic material. Therefore, repeatedly holstering and unholstering a gun can cut the gun holstering pocket. A holster liner can protect the gun holstering pocket. [0015] In accordance with yet another aspect of the embodiment, the entrance to the gun holstering pocket is shaped to allow one handed holstering. Stiffening, stretching or molding the opening of the gun holstering pocket can cause it remain somewhat open when no gun in holstered. Another way to form the opening is by fixing a wire, plastic, or similar element to the entrance to the gun holstering pocket. [0016] In accordance with yet another aspect of the embodiment, a slip resistant material can be fixed inside the magazine holstering pocket. The material can be, and probably should be, different from the comfortable slip resistant material used elsewhere. The slip resistant material will help keep the magazine in place, even if the magazine is pushed into the magazine holstering pocket from the underside. [0017] In accordance with yet another aspect of the embodiment, anti-ballistic material can be fixed to the band. Anti ballistic material is a material that can stop or slow a bullet or blade. Tactical body armor often uses solid plates or cloth formed from an aramid fiber as an antiballistic material. Fixing anti ballistic material to the band can protect the wearer's heart and lungs. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The accompanying figures, in which like reference numerals refer to identical or functionally similar elements throughout the separate views and which are incorporated in and form a part of the specification, further illustrate the present invention and, together with the background of the invention, brief summary of the invention, and detailed description of the invention, serve to explain the principles of the present invention. [0019] In accordance with an aspect of the embodiment, FIG. 1 shows a concealed carry apparatus; [0020] In accordance with an aspect of the embodiment, FIG. 2 shows a concealed carry apparatus; [0021] In accordance with an aspect of the embodiment, FIG. 3 shows a pocket assembly; [0022] In accordance with an aspect of the embodiment, FIG. 4 shows a pocket assembly and holster liner; [0023] In accordance with an aspect of the embodiment, FIG. 5 shows a pocket assembly with a shaped opening; [0024] In accordance with an aspect of the embodiment, FIG. 6 shows a concealed carry apparatus with anti ballistic material; [0025] In accordance with an aspect of the embodiment, FIG. 7 shows a concealed carry apparatus with two pocket assemblies; and [0026] In accordance with an aspect of the embodiment, FIG. 8 shows a person wearing a concealed carry apparatus. DETAILED DESCRIPTION OF THE INVENTION [0027] In accordance with an aspect of the embodiment, FIG. 1 shows a concealed carry apparatus. A band is made from an elastic strap 101 , a first end section 103 and a second end section 102 . The band can be passed around the torso or an extremity and the end sections joined such that the elastic strap 101 is lightly stretched. The second end section 102 is shown as an elongated piece because it enables the band to fit a range of body sizes. A pocket assembly 103 with a gun holstering pocket 104 and a magazine holstering pocket 105 can be formed from the elastic material. [0028] The end sections shown in FIG. 1 can be made with a hook and loop material. The first end section 103 can be hook material. The second end section 102 can be hook material. Using hook material with an elongated second end section 102 is advantageous because the hook material can help make the concealed carry apparatus more comfortable. [0029] In accordance with an aspect of the embodiment, FIG. 2 shows a concealed carry apparatus. It is essentially the same apparatus as that shown in FIG. 1 , but from a different perspective. The elastic strap 101 is shown folded back on itself because it is convenient to make the pocket assembly 103 from an uncut length of elastic strap material. The second end section 102 is shown extending through the entire length of the pocket assembly 103 because it can form an extra layer of material between a holstered gun and the wearer. A piece of comfortable slip resistant material 201 is shown where it can be sewn to the band. Observing the positions of the elastic strap 101 , second end section 102 , and comfortable slip resistant material 201 , it is obvious that all the layers can be sewn at once to join all the parts and to form the pocket assembly. [0030] In accordance with an aspect of the embodiment, FIG. 3 shows a pocket assembly 103 . The pocket assembly 103 is formed when, as discussed above, the elastic strap 101 , second end section 102 , and comfortable slip resistant material (not shown) are joined. The act of joining, sewing in particular, forms seams 301 . The seams 301 form the pocket assembly 103 . The seam pattern shown is adapted for a wearer of the concealed carry apparatus to have the magazine holstering pocket 105 in front of the gun holstering pocket. FIG. 3 also shows a trigger access hole 302 . [0031] In accordance with an aspect of the embodiment, FIG. 4 shows a pocket assembly with a holster liner 401 . As discussed above, a holster liner 401 can help prevent the elastic strap 101 from getting cut by repeated gun holstering and unholstering. The holster liner material can be stitched into the gun holstering pocket during that same operation as forms the pocket assembly 103 . [0032] In accordance with an aspect of the embodiment, FIG. 5 shows a pocket assembly with a shaped opening. The entrance to the gun holstering pocket 103 is shaped to allow one handed holstering. Stiffening, stretching or molding the opening to the gun holstering pocket 103 can cause it remain somewhat open when no gun in holstered. Another way to form the opening is by fixing a wire, plastic, or similar element to the entrance to the gun holstering pocket 103 . [0033] In accordance with an aspect of the embodiment, FIG. 6 shows a concealed carry apparatus with anti ballistic material 601 . The antiballistic material 601 is shown as a number of independent overlapping sections because antiballistic material 601 is rarely as elastic as the material used for the elastic strap 101 . If the antiballistic material 601 is sufficiently elastic, it can be used as the elastic strap 601 . Otherwise, the antiballistic material 601 must be fixed to the elastic strap 101 and second end section 102 via sewing or another fastening method. Note that the antiballistic material 601 can be fixed to only the elastic strap 101 , only the second end section 102 , or both. [0034] In accordance with an aspect of the embodiment, FIG. 7 shows a concealed carry apparatus with two pocket assemblies. The purpose of this figure is to show how easily a second pocket assembly 703 can be added to the concealed carry apparatus. The only major difference is that an extra piece of material 701 can be used to position the first end section 101 . Alternatively, the second pocket assembly 703 can also be an end section if a fastener, such as hook material 702 , is sewn to the outside surface. [0035] In accordance with an aspect of the embodiment, FIG. 8 shows a person wearing a concealed carry apparatus 802 . The concealed carry apparatus 802 encircles the torso of the person 801 and positively holds a gun 804 and a magazine 803 . The concealed carry apparatus shown is adapted for the person 801 to grab the gun 804 with the right hand. Another person can prefer a concealed carry apparatus adapted for left handed use. [0036] The embodiment and examples set forth herein are presented to best explain the present invention and its practical application and to thereby enable those skilled in the art to make and utilize the invention. Those skilled in the art, however, will recognize that the foregoing description and examples have been presented for the purpose of illustration and example only. Other variations and modifications of the present invention will be apparent to those skilled in the art following the reading of this disclosure, and it is the intent of the appended claims that such variations and modifications be covered. [0037] The description as set forth is not intended to be exhaustive or to limit the scope of the invention. Many modifications and variations are possible in light of the above teaching without departing from the scope of the following claims. It is contemplated that the use of the present invention can involve components having different characteristics. It is intended that the scope of the present invention be defined by the claims appended hereto, giving full cognizance to equivalents in all respects.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to barbeques and, more particularly to barbeque apparatus having a cantilevered, counterweighted pivoting lid and a pivoting counterweighted grate within a base. 2. Description of the Prior Art There are generally two types of barbeque grills, the first, and smallest, being a type that is generally considered a table-top barbeque. The table-top barbeque grill includes a firebox which may be conveniently disposed on a table, or the like, and a removable lid. Within the firebox there is a space for charcoal or for a gas pipe and a lid fits over the firebox and may be completely removed. A grill for supporting food to be cooked is disposed in the firebox. The second type of barbeque is a larger barbeque that generally includes the elements of the above described barbeque, but includes a base which supports the firebox. The base supports the firebox off of the ground or surface. The barbeque may include wheels on the base for easy portability, or the base may be permanently fixed in place. If the barbeque is fixed in place, there may be a removable lid to the firebox, or the barbeque may be without a lid. For the portable barbeques there is typically a lid. The lids are generally vented to allow for both smoke and steam to escape. In some cases, the lids may be pivoting, but they are generally not counterweighted. Otherwise, the lids are separable removable from the firebox. SUMMARY OF THE INVENTION The invention described and claimed herein comprises a barbeque apparatus which includes a base and a firebox cantilevered away from the face to provide easy accessability for a wheel chair, if desired. The barbeque apparatus includes a hinged and counterweighted lid which may be pivoted away from the firebox with relatively little effort. A grill in the firebox is also counterweighted to allow its pivoting with a minor amount of force or effort. Thus, for example, a wheel chair bound user may easily and conveniently use the barbeque apparatus. The counterweight for the lid is disposed in a vertical post which comprises part of the base. Among the objects of the present invention are the following: To provide new and useful barbeque apparatus; To provide new and useful barbeque apparatus having a cantilevered firebox and a counterweighted lid secured to the firebox; To provide barbeque apparatus having a firebox secured to a base and a counterweighted lid secured to the firebox and the counterweight is movable in a portion of the base; To provide new and useful barbeque apparatus having a counterweighted grill pivotally secured to a firebox; To provide new and useful barbeque apparatus having a firebox cantilevered outwardly from a supporting base structure; and To provide new and useful barbeque apparatus having a firebox cantilevered outwardly from a vertical support column and a lid pivotally secured to the firebox and a counterweight for the lid is movable vertically in the support column. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a perspective view of barbeque apparatus of the present invention. FIG. 2 is a view in partial section taken generally along line 2--2 of FIG. 1. FIG. 3 is an enlarged view in partial section of a portion of the apparatus illustrated in and sequentially following FIG. 2. FIG. 4 is an enlarged side view in partial section of a portion of the apparatus of the present invention. FIG. 5 is a view in partial section taken generally along line 5--5 of FIG. 1. FIG. 6 is an enlarged perspective view of a portion of the apparatus of the present invention taken generally from circle 6 of FIG. 5. FIG. 7 is a front view of an alternate embodiment of the apparatus of the present invention. FIG. 8 is a side view of the apparatus if FIG. 7. FIG. 9 is a front view of another alternate embodiment of the apparatus of the present invention. FIG. 10 is a side view of the apparatus of FIG. 9. FIG. 11 is a view in partial section taken generally along line 11--11 of FIG. 1. FIG. 12 is a view in partial section of an alternate embodiment of the apparatus of FIG. 11. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 is a perspective view of grill apparatus 10 of the present invention disposed on a concrete pad 2. The grill apparatus 10 includes a base plate 12 which is secured to the concrete pad 2. Extending upwardly from the base plate 12 is a pipe cylinder 14. The pipe cylinder 14 comprises a support for a firebox 30. Hingedly secured to the firebox 30 is a lid 60. FIG. 2 is a view in partial section taken through the upper portion of the pipe cylinder 14, through the firebox 30, and showing the lid 60 in its open position. FIG. 3 is an end view of the firebox 30 with the lid 60 in its closed position and showing the upper portion of the cylinder 14 in partial section. FIG. 4 is an enlarged view in partial section of the upper portions of the pipe cylinder 14. For the following discussion of the grill apparatus 10, reference will primarily be made to FIGS. 1, 2, 3, and 4. The grill apparatus 10 includes the base plate 12 which is secured to the concrete pad 2 by a plurality of appropriate fastener elements 13. Extending upwardly from the base plate 12, to which it is appropriately secured, as by welding, is a supporting cylindrical pipe or pipe cylinder 14. The pipe 14 extends upwardly from the base plate 12 and terminates in a top 16. Within the pipe 14 is a bore 18. In the bore 18 are two bushings, a top or upper bushing 20 and a lower or bottom bushing 22. The two bushings 20 and 22 are appropriately spaced apart. Extending outwardly from the supporting pipe 14, and downwardly from the top 16 of the pipe 14 is a support bracket 26. A support bracket 26 extends upwardly and outwardly to provide cantilevered support for the firebox 30. The support bracket 26 is preferably a pipe which is appropriately secured, as by welding, to both the pipe 14 and the firebox 30. At the juncture of the cylindrical pipe 14 and the plate 12 is a weep hole 24. The weep hole 24 communicates with the bore 18. Moisture condensing inside the cylinder 14, or rain, etc., flows out of the cylinder 14 through the weep hole 24. The firebox 30 is a curved or rounded element which includes a front edge 32 and a rear edge 34. The firebox 30 includes two ends, an end 36 and an end 42. The ends 36 and 42 are appropriately secured to the main element which comprises the firebox 30. The end 36 includes a front top edge 38 which extends rearwardly from the front edge 32. At the rear portion of the top front edge 38 is a rear upwardly sloping top edge 40. The edge 40 extends to the rear edge 34. The end 42 includes a top front edge 44 which is aligned with the edge 38 and which extends rearwardly from the front edge 32. A slot 46 extends downwardly from the edge 44 and is curved to receive a handle 124 which will be discussed below. A sloping rear portion 46 comprises the rear portion of the front edge 44 and is generally parallel to the sloping top edge 40. The lid 60 is appropriately hingedly secured to the box 30. The lid 60 includes a front edge 62 which is disposed on the front edge 32 of the firebox 30 when the lid is in its down position, as shown in FIG. 3. The lid 60 also includes a rear edge 64 which is disposed on the rear edge 34 of the firebox 30 when the lid is in its down position. The lid 60 and the firebox 30 are secured together by a hinge 66. The hinge 66 may comprise a pair of hinges spaced apart, or a single hinge, as desired. A handle 68 is secured to the lid 60 adjacent to the front edge 52. The handle extends outwardly from the lid 60 and includes a wooden portion to insulate a user from the hot lid when the grill apparatus is in use. The lid 60 also includes a pair of ends 70 and 76 which matingly engage the sides 36 and 42 of the firebox 30. The end 70 includes a front edge 72 which is aligned with the front edge 38 of the side 36, and a rear sloping edge 74 which is aligned with the sloping edge 40 of the end 36. The end 76 includes a vent 78 extending through it. The vent 78 may be covered with a wire mesh, is desired. The end 76 also includes a front edge 80 which is aligned with the front edge 44 of the side 42, and a rear edge 82 which is aligned with the sloping rear edge 48 of the end 42. With the lid 60 in the down position, as shown in FIG. 3, the respective edges are appropriately aligned, as indicated. A second insulated handle 84 is secured to the side 76 for convenience. Thus, a user, including a user in a wheel chair, may conveniently raise the lid 60 by either the front handle 68 or the side handle 84. While the lid 60 is hingedly secured to the firebox 30, it is also counterweighted for ease in raising and lowering the lid relative to the firebox 30. The counterweight assembly includes a link 90 which is appropriately secured again as by welding, to the lid 60 adjacent to the hinge 66 and the rear edge 64. The link 90 is pinned to a link 92 by a pin 94. The link 92, remote from the pin 94, is pinned to a weight 100. The weight 100 is disposed in the bore 8 and moves in the bushings 20 and 22. Extending upwardly at the top of the weight 100 is a tab 102. The tab 102 is a connecting element for the link 92. The link 92 is pivotally connected to the tab 102 by means of a pin 104. The movement of the links 90 and 92 and the lid 60 is illustrated in FIGS. 2 and 3. In FIG. 2, the lid 60 is shown raised to its up position, with the weight 100 downwardly in the bore 18 to its lower most position. As the lid 60 is closed, as shown in FIG. 3, the counterweight 100 moves upwardly in the bore 18 and the links 90 and 92 move appropriately relative to each other and to the weight 100. With the firebox 30 cantilevered outwardly from supporting pipe cylinder or post 14, a user in a wheel chair may have convenient access to the apparatus 10. With the lid 60 counterweighted, the lid 60 may be easily moved upwardly and downwardly with minimum effort, again very convenient for a user in a wheel chair. FIG. 5 is a top view of a portion of the grill apparatus 10 taken generally along line 5--5 of FIG. 1 through the firebox 30 and disclosing a grill 110 in plan view. FIG. 6 is a perspective view, partially broken away, of a portion of the grill 110 taken generally from circle 6 of FIG. 5. For the following discussion of the grill 110, reference will primarily be made to FIGS. 5 and 6. Reference may also be made to FIGS. 1 and 2. The grill 110 includes a pair of side frame members 112 and 114 to which are secured a plurality of spaced apart rods 116. The rods 116 are generally parallel to each other and generally perpendicular to the side frame members 14 to which they are appropriately secured. The rods 116 support food to be cooked. The side frame members 112 and 114 are spaced slightly inwardly from the side walls 36 and 42, respectively, of the firebox 30. A counterweight 118 also extends between the frame members 112 and 114 rearwardly of a pivot rod 120. The pivot rod 120 extends through apertures in the side walls 36 and 42 of the firebox 30. The pivot rod 120 extends through the side frame members 112 and 114 and outwardly therefrom and comprises a rod on which the grill 110 pivots relative to the firebox 30. Remote from the counterweight 118, and forwardly, toward the front of the firebox 30, is the handle 124. The handle 124 is disposed in the slot 46 in the end 42 when the grill is in the down position, as shown in FIG. 1 and 5. The handle 124 and the slot 46 is also shown in FIG. 3. The handle 124 is connected to a downwardly extending arm 122 and comprises essentially an outwardly extending insulated leg. The downwardly extending arm 122, as shown in FIG. 6, is appropriately secured, as by welding, to the frame member 114. The outwardly extending handle 124 is generally perpendicular to the arm 122. With the counterweight 118, the grill 110 may be raised upwardly, with a minimum of force, to provide access to the bottom of the firebox where coals, charcoal briquets, etc., may be placed prior to using the grill apparatus 30. FIG. 7 is a front view of a portion of the apparatus 30 with a mesh heat shield 130 secured to the front of the firebox 30. FIG. 8 is a side view in partial section of the grill apparatus 10 showing the heat shield 130 in partial section. For the following discussion, reference will primarily be made to FIGS. 7 and 8. The heat shield 130 comprises a curved mesh grill secured to the firebox 30 by brackets 132 and 134. The bracket 132 is the top bracket and bracket 134 is the bottom bracket. The mesh grill heat shield 130 is appropriately secured, as by welding to the brackets 132 and 134. The brackets 132 and 134 are appropriately secured, again preferably by welding, to the firebox 30. The mesh grill heat shield 130 extends from the upper portion of the firebox 30, adjacent to the front edge 32 (see FIGS. 1 and 2) downwardly to about the bottom of the firebox 30. The heat shield 130 also extends nearly the full width of the firebox, as shown in FIG. 7. An alternate embodiment heat shield 140 is shown in FIGS. 9 and 10. FIG. 9 is a front view of the apparatus I 0 and FIG. 10 is a side view of the apparatus 10. For the following discussion, reference will primarily be made to FIGS. 9 and 10. The heat shield 140 comprises a plurality of generally parallel wooden slats 142 appropriately secured to the firebox 30. Each slat 142 is spaced apart from the firebox 30 by a pair of spacers 144. Appropriately fasteners 146 are then used to secure slats 142 to both the spacers 144 and the firebox 130. The spacers 144 may simply be small sections of pipe appropriately secured, as by welding, to the firebox 30, or holes may be drilled in the firebox 130 to receive bolts or screws as fasteners 146 extend through the spacers and the screws are then extended to tapped apertures in the firebox 130. FIG. 11 is a plan view in partial section through the cylinder support post or pipe 14. The pipe 14 is shown in partial section secured to the base plate 12. The base plate 12 is in turn secured to the concrete pad 2 by a plurality of fasteners 13. The plate 14 is preferably a square plate, and the fasteners 13, which may be bolts, etc., are disposed adjacent to the four corners of the plate 12. Such fastening system provides a relatively fixed orientation of the grill apparatus 10 and may be appropriate for a backyard patio situation for a home, or on a concrete pad in a playground, a campground, etc. FIG. 12 is a plan view of an alternate base or support stand for the grill apparatus 10. Again, the pipe 14 is shown in partial section appropriately secured to the plate 12. However, the plate 12, instead of being relatively permanently affixed to the concrete pad, is appropriately secured to a support stand 150. The plate 12 may be welded to the stand 150 or it may be secured to the stand 150 by a plurality of fasteners, such as bolts, etc. (not shown). The stand 150 includes a rear member 152 to which the plate is secured, and a pair of outwardly extending side members 154 and 156. A pair of inwardly extending front side members 158 and 160 extend inwardly to the plate 12 from the outwardly extending side members 154 and 156, respectively. The inwardly extending front side members 158 and 160 are appropriately secured to the front corners of the plate 12. The orientation of the side members 154, 156 and the front side members 158, 160 allows a wheel chair to be accommodated close to the firebox 30 for the convenience of a person using the wheel chair and the grill apparatus 10. While the grill apparatus 10 may be permanently secured to a concrete pad, as shown in FIGS. 1 and 11, the grill apparatus 10 may also be secured to a stand, such as the stand 150, and disposed in an appropriate location, or moved, as desired. While the principles of the invention have been made clear in illustrative embodiments, there will be immediately obvious to those skilled in the art many modifications of structure, arrangement, proportions, the elements, materials, and components used in the practice of the invention, and otherwise, which are particularly adapted to specific environments and operative requirements without departing from those principles. The appended claims are intended to cover and embrace any and all such modifications, within the limits only of the true spirit and scope of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a U.S. nonprovisional patent application of, and claims priority under 35 U.S.C. §119(e) to, U.S. Provisional Patent Application No. 61/117,815, filed Nov. 25, 2008 and titled “SYRINGE AND METHOD FOR RECONSTITUTION OF DRY-FORM DRUGS AND MEDICINES.” The entire disclosure of such application is incorporated herein by reference. COPYRIGHT STATEMENT All of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND OF THE PRESENT INVENTION 1. Field of the Present Invention The present invention relates generally to the field of syringes, and in particular, to syringes for use with reconstituted drugs and medicines. 2. Background Syringes are very well known for use in administering drugs, medicines and the like in fluid (liquid or gaseous) form. A syringe is generally a simple piston pump having a plunger that fits tightly in a tube or barrel. By first pulling the plunger from one end of the barrel, a drug, medicine in liquid or gaseous form may be drawn into the barrel through an orifice at the opposite end. The plunger may then be pushed back into the barrel, causing the medicine to be expelled through the orifice. By fitting the orifice end with a hypodermic needle, the medicine may be injected into body tissues. Dosages of such injectable fluids, such as lidocaine, are commonly measured in milliliters (mL) or cubic centimeters (cc). FIG. 1 is a side view of a conventional syringe, marked in units of milliliters. A dosage of 1.0 mL may be measured by drawing enough of the liquid material up into the syringe such that the liquid passes the 1.0 mL marking on the barrel of the syringe. Conventionally, the syringe is held upside down, tapped to shake air bubbles to the top, and then expelling a small amount of the medicine to bring the level down to exactly 1.0 mL. The syringe is then ready for use. More particularly, if the syringe is a hypodermic syringe and the liquid is to be injected into a body tissue, the syringe is ready for such injection. For reconstituted drugs, it is well established that different dosages may utilize different concentrations of the medicine, drug or the like being administered. For example, a particular drug could be given in a dose of 1.0 mL, or could be diluted with 1.0 mL of saline, in which case the drug amount would remain the same but the total amount of liquid being administered would be 2.0 mL. However, there are some drugs for which it may be preferable to distribute the drug in a standardized concentration. This may be for convenience, safety, or any of a variety of other reasons. For example, in the United States, insulin is conventionally provided only in a concentration of 100 U/mL. In conjunction with this, insulin is provided in special syringes that are marked in “units” rather than in mL. In particular, insulin is often provided in syringes containing 50 or 100 standard units and marked in single unit increments. By using such a standardized approach, insulin can be manufactured, distributed and used in only a single standard concentration, with the end user being able to measure the proper dosage accurately without need for mathematical conversions or the like, thus making the administration of insulin safer and more convenient. Variable concentration levels may be utilized with regard to drugs and medicines that are distributed by the manufacturer in dry form (typically in the form of a vacuum-dried powder) and reconstituted by a medical practitioner or staff member. Some such drugs and medicines, such as botulinum toxin type A (sold for example under the trade names BOTOX®, DYSPORT®, Reloxin™ and Puretox™) and botulinum toxin type B (sold for example under the trade name Myobloc®), may be reconstituted from dry form of the drug to a variety of dilution or concentration levels. In some such drugs and medicines, however, there are various acceptable concentration (dilution) levels, some of which may be established by policy, by individual diagnosis, by personal preference, or the like. In practice, for example, BOTOX® (sometimes referred to herein as “Botox”) may be sold in various numbers of units per milliliter. Unfortunately, traditional syringes used in conjunction with reconstituted Botox, as well as with various other injectable fluids that are reconstituted by practitioners from their dry form, provide only an indication of fluid volume, and not the drug or medicine units contained therein. The situation is further complicated by the fact that different manufacturers sometimes use different standard units to measure otherwise comparable versions of some drugs and medicines. For example, although very similar, Botox is commonly provided by the manufacturer in 100-unit packages or increments, while DYSPORT® (sometimes referred to herein as “Dysport”) is commonly provided by the manufacturer in 300-unit packages or increments, and the relative units are not necessarily equivalent. Thus, a need still exists for apparatuses and methods for proper reconstitution and subsequent handling and administering of injectable fluids distributed to practitioners in dry-form. SUMMARY OF THE PRESENT INVENTION Broadly defined, the present invention according to one embodiment is a method of reconstituting and administering an injectable fluid distributed to practitioners in dry-form, including: receiving a drug or medicine in dry form; selecting a reconstitution concentration for the drug or medicine; reconstituting a desired number of units of the drug or medicine by adding diluent to the dry-form drug or medicine; selecting a syringe having units marked according to the selected reconstitution concentration; drawing up a desired number of drug or medicine units using the selected syringe; and administering a desired number of units according to the unit markings on the selected syringe. A method of reconstituting and administering an injectable drug or medicine, distributed to practitioners in dry form, including: receiving a drug or medicine in dry form; selecting a reconstitution concentration for the drug or medicine; reconstituting a desired number of units of the drug or medicine by adding diluent to the dry-form drug or medicine; selecting a syringe marked in correspondence to the selected reconstitution concentration; drawing up a desired number of drug or medicine units using the selected syringe; and administering a desired number of units according to the unit markings on the selected syringe. In a feature of this aspect, the step of selecting a reconstitution concentration includes selecting the reconstitution concentration from a plurality of different standardized reconstitution concentrations. In a further feature, the step of selecting a syringe includes selecting the syringe from a plurality of differently-marked syringes, wherein the markings on each of the plurality of syringes is representative of a particular standardized reconstitution concentration of the plurality of different standardized reconstitution concentrations. In a further feature, the selected syringe is marked with units according to the selected reconstitution concentration, thereby indicating to a user the number of units of the drug contained in the syringe. In a still further feature, the selected syringe is marked with an alphanumeric character indicating, to a user, the selected reconstitution concentration. In further features, the alphanumeric character includes a number representative of the number of mL of diluent to be added to a predetermined quantity of the dry-form drug, thereby reconstituting the drug (and, optionally, the predetermined quantity of the dry-form drug is 100 units or 300 units); the alphanumeric character includes a letter; and/or the alphanumeric character includes a code representative of the selected reconstitution concentration. In a still further feature, the selected syringe is marked with a non-alphanumeric code that is representative of the selected reconstitution concentration. In further features, the non-alphanumeric code includes one or more rings wherein the number of rings is indicative of the selected reconstitution concentration; and/or the non-alphanumeric code includes a color code wherein the color of one or more elements of the syringe are indicative of the selected reconstitution concentration. In a still further feature, the reconstituting step includes reconstituting the desired number of units of the drug or medicine by adding the diluent to the dry-form drug or medicine at the selected reconstitution concentration. In a still further feature, the selected syringe is marked with a manufacturing source identifier, thereby indirectly providing an indication of the unit measure, of a plurality of possible unit measures, with which the selected syringe is to be used. In a still further feature, the selected syringe is marked with an indication of the unit measure, of a plurality of possible unit measures, with which the selected syringe is to be used. Broadly defined, the present invention according to another embodiment is a syringe for use with reconstitution and administration of an injectable drug, distributed to practitioners in dry-form, including: a barrel; a plunger assembly, including a plunger handle and a piston; a needle; and a needle cap; wherein at least one of the barrel, plunger assembly and needle cap include a visual indicia, representative of a first concentration of a drug in a reconstituted injectable fluid contained in the barrel, that is distinguishable from a corresponding visual indicia, on a second syringe, that is representative of a second concentration of a drug in a reconstituted injectable fluid contained in the second syringe. In a feature of this aspect, each visual indicia is in the form of a number, such that the particular number indicates the respective concentration. In another feature of this aspect, each visual indicia is in the form of one or more rings, such that the particular number of rings indicates the respective concentration. In another feature of this aspect, each visual indicia is in the form of a color, such that the particular color indicates the respective concentration. In another feature of this aspect, each of the barrel, plunger assembly and needle includes the visual indicia. In another feature of this aspect, the syringe is marked with a manufacturing source identifier, thereby indirectly providing an indication of the unit measure, of a plurality of possible unit measures, with which the syringe is to be used. In another feature of this aspect, the syringe is marked with an indication of the unit measure, of a plurality of possible unit measure, with which the syringe is to be used. Broadly defined, the present invention according to another embodiment is a method of distributing an injectable drug or medicine, provided in dry form, for reconstitution and administration, including: packaging an injectable drug or medicine, in dry form, for distribution; procuring a supply of syringes for use with a reconstituted form of the dry-form injectable drug or medicine, wherein each syringe is marked in such a way as to indicate, to a user, the concentration of the drug or medicine to be contained in the syringe when reconstituted and drawn thereinto, and wherein the supply of syringes include a multitude of each of a plurality of differently-marked syringes such that different syringes are to be used with different reconstitution concentrations; and providing a quantity of the injectable drug or medicine to a practitioner in conjunction with one or more syringe together with printed information instructing a user with regard to the reconstitution of the drug or medicine in the concentration corresponding to the marking on the one or more syringe. Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS Further features, embodiments, and advantages of the present invention will become apparent from the following detailed description with reference to the drawings, wherein: FIG. 1 is a side view of a conventional syringe, marked in units of milliliters; FIG. 2 is a side view of a hypodermic syringe marked with dosage unit increments in accordance with one or more preferred embodiments of the present invention; FIG. 3 is a side cross-sectional view of the syringe of FIG. 2 ; FIG. 4 is a side view of a hypodermic syringe similar to that of FIG. 2 but marked in different dosage unit increments; FIGS. 5A and 5B are side views of hypodermic syringes similar to that of FIG. 2 but with markings indicating the concentration of the drug that is to be drawn into the respective syringe; FIG. 6 is a flowchart illustrating the steps of a method of use in accordance with one or more preferred embodiments of the present invention; FIG. 7 is a side view of a hypodermic syringe similar to that of FIG. 2 but marked with a manufacturing source identifier and an indication of the unit measure; and FIG. 8 is a side view of the hypodermic syringe of FIG. 2 , shown with a full 50 units drawn up therein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As a preliminary matter, it will readily be understood by one having ordinary skill in the relevant art (“Ordinary Artisan”) that the present invention has broad utility and application. Furthermore, any embodiment discussed and identified as being “preferred” is considered to be part of a best mode contemplated for carrying out the present invention. Other embodiments also may be discussed for additional illustrative purposes in providing a full and enabling disclosure of the present invention. Moreover, many embodiments, such as adaptations, variations, modifications, and equivalent arrangements, will be implicitly disclosed by the embodiments described herein and fall within the scope of the present invention. Accordingly, while the present invention is described herein in detail in relation to one or more embodiments, it is to be understood that this disclosure is illustrative and exemplary of the present invention, and is made merely for the purposes of providing a full and enabling disclosure of the present invention. The detailed disclosure herein of one or more embodiments is not intended, nor is to be construed, to limit the scope of patent protection afforded the present invention, which scope is to be defined by the claims and the equivalents thereof. It is not intended that the scope of patent protection afforded the present invention be defined by reading into any claim a limitation found herein that does not explicitly appear in the claim itself. Thus, for example, any sequence(s) and/or temporal order of steps of various processes or methods that are described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal order, the steps of any such processes or methods are not limited to being carried out in any particular sequence or order, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and orders while still falling within the scope of the present invention. Accordingly, it is intended that the scope of patent protection afforded the present invention is to be defined by the appended claims rather than the description set forth herein. Additionally, it is important to note that each term used herein refers to that which the Ordinary Artisan would understand such term to mean based on the contextual use of such term herein. To the extent that the meaning of a term used herein—as understood by the Ordinary Artisan based on the contextual use of such term—differs in any way from any particular dictionary definition of such term, it is intended that the meaning of the term as understood by the Ordinary Artisan should prevail. Furthermore, it is important to note that, as used herein, “a” and “an” each generally denotes “at least one,” but does not exclude a plurality unless the contextual use dictates otherwise. Thus, reference to “a picnic basket having an apple” describes “a picnic basket having at least one apple” as well as “a picnic basket having apples.” In contrast, reference to “a picnic basket having a single apple” describes “a picnic basket having only one apple.” When used herein to join a list of items, “or” denotes “at least one of the items,” but does not exclude a plurality of items of the list. Thus, reference to “a picnic basket having cheese or crackers” describes “a picnic basket having cheese without crackers”, “a picnic basket having crackers without cheese”, and “a picnic basket having both cheese and crackers.” Finally, when used herein to join a list of items, “and” denotes “all of the items of the list.” Thus, reference to “a picnic basket having cheese and crackers” describes “a picnic basket having cheese, wherein the picnic basket further has crackers,” as well as describes “a picnic basket having crackers, wherein the picnic basket further has cheese.” Referring now to the drawings, in which like numerals represent like components throughout the several views, the preferred embodiments of the present invention are next described. The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. FIGS. 2 and 3 are a side view and a side cross-sectional view of a hypodermic syringe 10 in accordance with one or more preferred embodiments of the present invention. It will be appreciated that, for the sake of clarity, the syringe 10 of FIG. 2 is shown as being at least partially transparent, wherein broken lines are used to indicate interior surfaces. With reference to both FIGS. 2 and 3 , the syringe 10 may be constructed generally conventionally, with a barrel 20 , a plunger assembly 30 and a hollow needle 18 . The barrel 20 defines an interior cylinder 22 within which the plunger assembly 30 is fitted. The plunger assembly 30 includes a piston 32 , a rubber gasket 34 and a handle 36 extending from one end of the barrel 20 . The hollow needle 18 is coupled, preferably removably such as via a hand-tightened threaded fitting such as a Luer lock, to the opposite end of the barrel 20 , and the interior of the needle 18 is in fluid communication with the interior of the barrel 20 . As a safety precaution, the needle 18 is typically covered with a removable cap (not shown) when not in use. Notably, the barrel 20 of the syringe 10 of FIGS. 2 and 3 is marked in increments of dosage units rather than in hundredths of mL, as in the conventional syringe of FIG. 1 . In particular, as shown in FIG. 2 , the barrel 20 has increments totaling 50 units. If the syringe 10 is a 1 mL syringe (i.e., of the same volume as the syringe of FIG. 1 ), then the syringe 10 shown in FIG. 2 is to be understood to have, and should preferably only be used with, a dosage concentration of 50 units (“U”)/1 mL. FIG. 4 , on the other hand, is a side view of a hypodermic syringe 110 that is generally similar to that of FIG. 2 but is marked in different dosage unit increments. In particular, the barrel 120 has increments totaling 40 units. If the syringe 110 is a 1 mL syringe (i.e., of the same volume as the syringe of FIG. 1 and as the syringe 10 of FIG. 2 ), then the syringe 110 shown in FIG. 4 is to be understood to have, and should preferably only be used with, a dosage concentration of 40 units (“U”)/1 mL. The barrel 20 may also be marked to indicate the concentration level of the solution in the syringe 10 , i.e, the amount of diluent that is used to reconstitute the drug. The capacity may be marked by printing a number 42 , a code 44 (such as a number of rings), or the like, representative of the concentration (in U/mL) of the syringe 10 , on the barrel 20 thereof. For example, the number 42 , code 44 , or the like may directly indicate the amount of diluent used to reconstitute 100 units of the drug. In one such implementation, a “#1” syringe (marked “1” and/or having one ring around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 1 mL of saline for every 100 units of the drug, a “#2” syringe (marked “2” and/or having two rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 2 mL of saline for every 100 units of the drug, a “#3” syringe (marked “3” and/or having three rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 3 mL of saline for every 100 units of the drug, a “#4” syringe (marked “4” and/or having four rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 4 mL of saline for every 100 units of the drug, and a “#5” syringe (marked “5” and/or having five rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 5 mL of saline for every 100 units of the drug. In this example, it will be appreciated that a #1 1 mL syringe, if fully drawn up, would thus contain 100 units of the drug, a #2 1 mL syringe, if fully drawn up, would thus contain 50 units of the drug, a #3 1 mL syringe, if fully drawn up, would thus contain 33 units of the drug, a #4 1 mL syringe, if fully drawn up, would thus contain 25 units of the drug, and a #5 1 mL syringe, if fully drawn up, would thus contain 20 units of the drug. Two such syringes are illustrated in FIGS. 5A and 5B , wherein the syringe 210 in FIG. 5A has a “4” printed near one end of the barrel 220 and 4 rings printed near the opposite end of the barrel 220 and thus contains a concentration of 4 mL of diluent per 100 units of the drug, while the syringe 310 in FIG. 5B has a “2” printed near one end of the barrel 320 and 2 rings printed near the opposite end of the barrel 320 and thus contains a concentration of 2 mL of diluent per 100 units of the drug. In another such implementation, an “A” syringe (marked “A” and/or having one ring around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 1.0 mL of saline for every 100 units of the drug, a “B” syringe (marked “B” and/or having two rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 2.0 mL of saline for every 100 units of the drug, a “C” syringe (marked “C” and/or having three rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 2.5 mL of saline for every 100 units of the drug, a “D” syringe (marked “D” and/or having four rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 4.0 mL of saline for every 100 units of the drug, and an “E” syringe (marked “E” and/or having five rings around the barrel) may indicate that the drug in the syringe has been reconstituted or diluted at a concentration of 8.0 mL of saline for every 100 units of the drug. In this example, it will be appreciated that a 1 mL “A” syringe, if fully drawn up, would thus contain 100 units of the drug, a 1 mL “B” syringe, if fully drawn up, would thus contain 50 units of the drug, a 1 mL “C” syringe, if fully drawn up, would thus contain 40 units of the drug, a 1 mL “D” syringe, if fully drawn up, would thus contain 25 units of the drug, and a 1 mL “E” syringe, if fully drawn up, would thus contain 12.5 units of the drug. Alternatively, the markings (number 42 , rings 44 , or the like) may be used to more directly indicate the number of units contained in the syringe 10 , 110 , 210 , 310 . Color-coding may also be utilized on one or more parts of the syringe 10 , 110 , 210 , 310 to make it easier to distinguish, both for those reconstituting the drug and for those drawing up the syringe 10 , 110 , 210 , 310 , the number of units that are or should be contained therein. For example, all or portions of the barrel 20 , 120 , 220 , 320 , the plunger handle 36 , and/or the cap over the needle 18 may be made of colored material or otherwise colored in some way based on the capacity of the syringe 10 , 110 , 210 , 310 , the number of units contained therein, or the like. The colors may likewise be coordinated with printed material included on charts, instructions, packaging, or the like in order to established a uniform, easily-followed guide for reconstitution and use of the drug and the syringe 10 , 110 , 210 , 310 . In one such implementation, a “#1” syringe includes a red plunger handle and needle cap, a “#2” syringe includes an orange plunger handle and needle cap, a “#3” syringe includes a yellow plunger handle and needle cap, a “#4” syringe includes a green plunger handle and needle cap, a “#5” syringe includes a blue plunger handle and needle cap, and accompanying packaging and printed instructions include color-coordination information and indicia to help the user utilize each syringe properly such that the concentrations described previously for #1, #2, #3, #4 and #5 syringes are drawn up in each one. Information about the chosen color coding system may also be disseminated to patients so that they may readily recognize, understand and use the proper concentration, and thus the proper number of units of the drug. In at least one embodiment, the barrel 20 , 120 , 220 , 320 , the plunger handle 36 , and the cap are marked with the generic name and/or the brand name of the drug in order to assure that the syringe 10 , 110 , 210 , 310 is assembled properly and used with the proper drug. The dimensions of the syringe 10 , 110 , 210 , 310 are chosen so that a sufficient volume of injectable fluid may be drawn up within the interior cylinder 22 for administration to a patient. The barrel 20 , 120 , 220 , 320 of the syringe 10 , 110 , 210 , 310 may be constructed of any conventional syringe material, including glass, polyethylene, polycarbonate, or polyvinyl or other synthetic polymer or various other plastics, and is preferably transparent or translucent such that the fluid or plunger assembly 30 may be viewed within. The plunger assembly 30 is likewise constructed from any suitable inert material including, but not limited to, plastic, vinyl, polyethylene, rubber, platinum-cured silicon or TEFLON®. In at least one embodiment, the interior volume of the syringe 10 , 110 , 210 , 310 is slightly more than 1 mL such that an amount of substantially exactly 1 mL of injectable fluid may be contained therein. However, it will be appreciated that other volumes may likewise be utilized. FIG. 6 is a flowchart illustrating the steps of a method of use 600 in accordance with one or more preferred embodiments of the present invention. The method 600 begins at step 605 with the receipt, by a medical practitioner, facility, organization of the like of an injectable drug, medicine or the like in dry, reconstitutable form. Such injectable drugs or medicines are often provided in vacuum-dried form, and include, without limitation, botulinum toxin type A (sold or planning to be sold under the trade names BOTOX®, Dysport®, Reloxin™ and Puretox™) and botulinum toxin type B (sold under the trade name Myobloc®), both frequently administered for the treatment of facial wrinkles Botox, for example, is typically supplied in vials containing 100 units of Botox in dry form. Such dry-form drugs may often be reconstituted in a variety of concentrations, often depending on practitioner preference. For example, Botox is commonly reconstituted in concentrations of 1.0 mL of diluent (typically nonpreserved normal saline, or 0.9% sodium chloride injection) per 100 units of Botox for a dosage concentration of 10.0 U of Botox per 0.1 mL (100 U/1 mL), 2.0 mL of diluent per 100 units of Botox for a dosage concentration of 5.0 U of Botox per 0.1 mL (50 U/1.0 mL), 2.5 mL of diluent per 100 units of Botox for a dosage concentration of 4.0 U of Botox per 0.1 mL (40 U/1 mL), 4.0 mL of diluent per 100 units of Botox for a dosage concentration of 2.5 U of Botox per 0.1 mL (25 U/1 mL), or 8.0 mL of diluent per 100 units of Botox for a dosage concentration of 1.25 U of Botox per 0.1 mL (12.5 U/1 mL). At step 510 , a desired reconstitution concentration is selected. Preferably, the concentration is selected according to a particular policy, e.g., a particular medical facility may have a policy of providing all dosages in a concentration of 50 U/1 mL, or according to a particular prescription, e.g., a practitioner may prescribe use of a concentration of 40 U/1 mL. At step 615 , a desired number of units may be reconstituted according to the desired dosage concentration. Perhaps most conveniently, an entire vial of the vacuum-dried drug may be reconstituted at once, but portions of vials may in some cases be reconstituted, or multiple vials are reconstituted at once. Reconstitution may be carried out according to conventional procedures, and care should be taken to ensure that the proper concentration is achieved and properly labeled or otherwise tracked before being drawn up into individual syringes. Based on the dosage concentration present in the injectable fluid, one or more corresponding syringe is selected at step 620 for use therewith. More particularly, a syringe, such as the hypodermic syringe 10 of FIG. 2 , having unit markings corresponding with the dosage concentration is selected for use with the dosage concentration. Care should be taken to ensure that only a properly-marked syringe is utilized for each particular dosage concentration. The syringe 10 in FIG. 2 , for example, is labeled for use with a dosage concentration of 50 U/1 mL, and thus should only be used for an injectable fluid having a dosage concentration of 50 U/1 mL. On the other hand, the syringe 110 in FIG. 4 is labeled for use with a dosage concentration of 40 U/1 mL, and thus should only be used for an injectable fluid having a dosage concentration of 40 U/1 mL. It is also recognized that different drugs are provided by different manufacturers in different standard units. For example, although Botox and Dysport are very similar, Botox is commonly provided by the manufacturer in 100-unit packages or increments, while Dysport is commonly provided by the manufacturer in 300-unit packages or increments, and the relative units are not necessarily equivalent. Thus, to help ensure that reconstituted units of a drug are drawn up or otherwise utilized with a syringe that is properly calibrated for that drug, each syringe may be marked with an indication of the drug manufacturer with which the syringe is to be used, with an indication of the standard number of units in which the drug is to be used, or both. For example, FIG. 7 is a side view of a hypodermic syringe 410 similar to that of FIG. 2 but marked with a manufacturing source identifier 446 and an indication 448 of the unit measure. In particular, the manufacturing source identifier 446 on the syringe 410 in FIG. 7 indicates that the syringe 410 is to be used with BOTOX®, which is manufactured by (or possibly under license from) Allergan, Inc. of Irvine, Calif., and the unit measure indication 448 on the syringe 410 in FIG. 7 indicates that the syringe 410 is to be used with a drug, such as BOTOX®, that is supplied in 100-unit increments (rather than, for example, a drug, such as DYSPORT®, that is supplied in 300-unit increments. Selection of a syringe based on manufacturing source identifier 446 , unit measure indication 448 , or both may be incorporated into step 620 . Using the proper syringe 10 , 110 , 210 , 310 , 410 an amount of the injectable fluid corresponding to a desired number of units of the drug may be drawn up at step 625 . For example, FIG. 8 is a side view of the hypodermic syringe 10 of FIG. 2 , shown with a full 50 units drawn up therein. Finally, a desired number of units (which may be some or all of the units that have been drawn up) are administered at each injection site at step 630 . Advantageously, assuming the proper concentration is prepared, the syringes and methods of use of the present invention help to ensure that each syringe is drawn up with the proper concentration of drug. Also advantageously, assuming the proper concentration is prepared and properly drawn into the syringe, the syringes and methods of use of the present invention help to ensure that the proper dosage of the drug is injected. Also advantageously, assuming the proper concentration is prepared and properly drawn into the syringe, the syringes and methods of use of the present invention help to ensure that the patient receives the proper number of units of the drug. Overall, although the present invention cannot prevent an individual from intentionally preparing the wrong concentration or utilizing the wrong syringe for the reconstituted drug, the syringes and methods of use of the present invention advantageously help to avoid accidental errors of these types. Based on the foregoing information, it is readily understood by those persons skilled in the art that the present invention is susceptible of broad utility and application. Many embodiments and adaptations of the present invention other than those specifically described herein, as well as many variations, modifications, and equivalent arrangements, will be apparent from or reasonably suggested by the present invention and the foregoing descriptions thereof, without departing from the substance or scope of the present invention. Accordingly, while the present invention has been described herein in detail in relation to its preferred embodiment, it is to be understood that this disclosure is only illustrative and exemplary of the present invention and is made merely for the purpose of providing a full and enabling disclosure of the invention. The foregoing disclosure is not intended to be construed to limit the present invention or otherwise exclude any such other embodiments, adaptations, variations, modifications or equivalent arrangements; the present invention being limited only by the claims appended hereto and the equivalents thereof. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for the purpose of limitation.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a division and claims the benefit of U.S. Non-Provisional application Ser. No. 15/245,001, filed Aug. 23, 2016, which is a division and claims the benefit of Ser. No. 14/799,500, filed Jul. 14, 2015 which claims the benefit of U.S. Provisional Application No. 62/024,318, filed Jul. 14, 2014, which are hereby incorporated by reference, to the extent that they are not conflicting with the present application. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISC APPENDIX [0003] Not Applicable BACKGROUND OF THE INVENTION 1. Field of the Invention [0004] The invention relates generally to firefighting products and methods and more particularly to fire and smoke prevention compositions and the processes of making them. 2. Description of the Related Art [0005] In United States, a home fire occurs every 85 seconds. On average, and depending on the area and department, the fire department takes about 3-5 minutes to respond to a fire. In 2012, a total of 2,405 lives were lost in and a total of 13,175 injuries reported from residential fires. An estimated 50%-80% of fire deaths are from smoke inhalation. Too much smoke inhalation puts too much carbon monoxide into the lungs and could possibly cause brain damage because the carbon monoxide prohibits red blood cells from transferring oxygen into your body and carbon dioxide out of your body. On average, it would take 15 minutes of straight smoke, with no oxygen, to kill someone and 5-10 minutes to cause permanent brain damage. In addition, some people experience long term lung problems following smoke inhalation. [0006] Oftentimes, the deaths and injuries occur because people are trapped in a bedroom or other rooms of the house, and flames and/or smoke are/is penetrating into the room through door gaps (i.e., the gaps between the door and the floor of the room, hereinafter “door gap” or “floor gap,” and between the door and its frame, also known as door jambs, hereinafter “door gap” or “door jamb gap”), exposing the trapped people to smoke and/or flames before firefighters can save them. [0007] Thus, there is a need for a product that can be easily and safely (e.g., non-toxic) applied by people in the door gaps, and that is effective in preventing smoke and/or flames from entering the room, for a sufficient amount of time, such that trapped people can be saved before they incur injuries or death. [0008] Fire shelters can be a means of protection for firefighters when trapped by fires. The best fire shelters need a combination of three elements to address the three types of heat: radiant, convective, and conductive heat. The first element can be a reflective barrier, which can repel exposed flame, but cannot stop convection. The second element should address this, and it is known in the prior art to use an air pocket polyacrylate insulation barrier in a fire shelter. However, even with effective radiant and convective heat barriers, conductive heat is still a problem due to the direct contact between the reflective and insulation barriers, and due to this fire shelters can fail. Therefore, there is a need for a product that can address all three types of heat in a fire shelter. [0009] FIG. 1 a - c b show prior art, the New Generation Fire Shelter 101 used by the U.S. Forestry (U.S.F.), with an aluminum foil outer shell with a silica weave bound by an adhesive glue. Firefighters may carry a fire shelter 101 on their backs in a pack 102 as a last line of defense. The weak point is the adhesive having a low melting point relative to the other components, of 500 degrees Fahrenheit. The adhesive can melt and cause the foil to “bubble” away from the silica weave underneath, as shown by a fire shelter after used in a fire 101 - a , removing the reflective ability of the fire shelter. The aluminum foil used in the U.S. Forestry fire shelter also failed in some cases due to the 1400 degrees Fahrenheit melting point of the foil. Although most forest fires have a temperature of 800 degrees Fahrenheit, the temperature at which wood is combustible, once wind is introduced, a furnace effect can occur and the temperature is greatly increased. Peak heat can surpass 1400 degrees Fahrenheit. Due to the glue melting at 500 degrees and the duration of their entrapment, some firefighters have died in wildland fires. Even in the cases where the fire shelters are successful, some firefighters still received second- and third-degree burns from touching the fire shelter wall, due to the convection heat that passes through the framework and stitching and into the wall creating radiant heat inside of the shelter. Therefore, there is a need for a fire shelter that can withstand higher temperatures and create a safer environment on the inside. [0010] Absorbing polymers may be considered for use in insulating barriers to protect from fire. Sodium polyacrylate (C 3 H 3 NaO 2 ) is an example of a super-absorbing polymer. It is a cross-linked (network) polymer that contains sodium atoms, and it absorbs water through osmosis. As water is being absorbed by the polymer, sodium molecules are extracted and collected around the hydrated polymer cell. Because of salt's strong ionic bonds, they are ideal at forming an insulation barrier around the hydrated polymer cells, keeping them from melting or evaporating at a heat that would normally do so. BRIEF SUMMARY OF THE INVENTION [0011] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key aspects or essential aspects of the claimed subject matter. Moreover, this Summary is not intended for use as an aid in determining the scope of the claimed subject matter. [0012] In an embodiment, a nontoxic, flame and smoke resistant composition, combining a polymer and water to obtain a gelatinous substance that is easy to use and have a long shelf life, is provided. An advantage of the composition is that, when placed in gaps between a door and door jambs and between a door and the floor, it stops fire and smoke from penetrating a room, and thus, it potentially saves lives. [0013] In another embodiment, color is added to the composition to make it more easily detectable by firefighters and easier to find trapped people behind doors that were sealed with the composition. [0014] In another embodiment, a flow agent is added to the composition so that it can be sprayed onto a fire, to extinguish it. [0015] In another embodiment, the composition may be incorporated into a material to be used as a fire shelter or blanket, as examples. Thus an advantage is protection from fire with a combination of a radiant and convection barriers. [0016] The above embodiments and advantages, as well as other embodiments and advantages, will become apparent from the ensuing description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0017] For exemplification purposes, and not for limitation purposes, embodiments of the invention are illustrated in the figures of the accompanying drawings, in which: [0018] FIG. 1 a - c b show prior art, the New Generation Fire Shelter 101 used by the U.S. Forestry. [0019] FIG. 2 shows a colored gel embodiment of a polyacrylate composition. [0020] FIGS. 3 a - b show a side perspective view and a front perspective view, respectively, of a 1/10 scale door and frame built to simulate a room door. [0021] FIG. 4 shows smoke used for a fire test with the scale door of FIGS. 2 a - b. [0022] FIG. 5 shows a propane torch held 3 to 4 inches from the bottom of the door and floor gap of the scale door of FIGS. 2 a - b. [0023] FIG. 6 is a line graph showing the change in temperature in degrees Fahrenheit over the course of the ten minutes, in seconds, of various parts of the scale door of FIGS. 3 a - b. [0024] FIG. 7 shows Table 1 summarizing the results and observations of smoke and fire tests conducted for various other mixtures. [0025] FIG. 8 shows Table 2, listing the time in seconds that it took for fire or smoke to penetrate to the other side of the door within a 10 minute time frame of the smoke and fire experiments. [0026] FIG. 9 shows a bar graph depicting the data from Table 2 of FIG. 8 . [0027] FIG. 10 shows the 1/10 scale door of FIGS. 3 a - b in a box, with a piece of carpet stapled and glued to the floor of the box. [0028] FIGS. 11 a - f show the steps of making a scale fire shelter using a fire shelter frame, polyacrylate blanket with or without hydration, and using them to conduct a convection test. [0029] FIG. 12 a shows Table 3 summarizing the results of the convection tests using the hydrated polyacrylate, dry polyacrylate, and U.S. Forestry fire shelters. [0030] FIG. 12 b shows a line graph illustrating the results of the convection tests using the hydrated polyacrylate, dry polyacrylate and U.S. Forestry fire shelters. [0031] FIG. 13 a shows Table 4 summarizing the results of the experiments testing the hydrated polyacrylate fire shelter with and without a reflective shield. [0032] FIG. 13 b shows a line graph illustrating the results of test of the hydrated polyacrylate with and without a reflective shield. [0033] FIGS. 14 a - b show a propane torch lit and the flame held towards a U.S. Forestry fire shelter and a hydrated polyacrylate fire shelter, respectively. [0034] FIG. 15 a shows Table 5 summarizing the results of the experiments testing open flame radiation on a hydrated polyacrylate fire shelter and a U.S. Forestry fire shelter. [0035] FIG. 15 b shows a line graph illustrating the results of the open flame radiation tests using a hydrated polyacrylate and U.S.F. fire shelter. [0036] FIG. 16 a shows a raw egg in a Corningware bowl completely submerged in tap water, with a thermometer probe also placed in the water. [0037] FIG. 16 b shows the egg, bowl, and thermometer probe of FIG. 16 a wrapped in aluminum foil. [0038] FIG. 17 a shows Table 6 summarizing the results of the experiments testing the endothermic response of water with and without a reflective shield. [0039] FIG. 17 b shows a line graph illustrating the results of the experiments testing the endothermic response of water with and without a reflective shield [0040] FIGS. 18 a - j show the status of the eggs used after each experiment. [0041] FIG. 19 shows a bar graph illustrating the rests of the aluminum foil shiny and dull side comparison test. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0042] What follows is a detailed description of the preferred embodiments of the invention in which the invention may be practiced. The specific preferred embodiments of the invention, which will be described herein, are presented for exemplification purposes, and not for limitation purposes. It should be understood that structural and/or logical modifications could be made by someone of ordinary skills in the art without departing from the scope and essence of the invention. [0043] In an embodiment, a fire and smoke prevention composition is disclosed. The composition includes sodium polyacrylate (C 3 H 3 NaO 2 ), distilled water and a color agent (e.g., food red dye #5 and/or yellow dye #5). [0044] The sodium polyacrylate compound is known to be an excellent water absorbent. The United States Department of Agriculture (USDA) has developed sodium polyacrylate in the 1960s as a water absorbent for agriculture. With its ability to store water at up to 400 times its weight, this property made it very effective in low rainfall areas. Sodium polyacrylate, which may be best known as superabsorbent polymer (SAP), has several other uses, including the manufacturing of diapers and adult hygiene products. [0045] Distilled water is a well-known substance. Distilled water is better than tap water for use with the composition because, as it will be explained later, when describing the experiments conducted, with distilled water the composition does not break down. [0046] The color agent may be for example a food red dye, a food yellow dye, or even better, a mixture of red and yellow (e.g., 50% red and 50% yellow) dye, so that the fire and smoke prevention composition has a dark orange color. When the composition has a dark orange color, a flashlight pointed on it appears to cause the reflection of an easy-to-spot, neon-like light. This may help firefighters more easily locate trapped persons behind doors, the gaps 306 of which were treated with the composition. It should be noted that the fire and smoke prevention composition would work well (i.e., sealing the door gaps 306 ) without the color agent. However, the adding color to the composition makes the composition even more beneficial as explained above. [0047] The resulting composition (i.e., sodium polyacrylate plus distilled water, with or without the color agent) is a gelatin-like substance that is effective (e.g., will not run) at sealing door gaps in order to prevent smoke and fire from entering the room, suppress the fire, and to obtain other beneficial outcomes, as described herein. To apply the gelatinous composition, a ⅜″ (three eighths of an inch) for example nozzle (on a squeezable bottle for example) may be used, which is optimum for most door gaps. [0048] To make the fire and smoke prevention composition without the color or flow agents, the following process may be followed. First, preferably 2 (two) grams of sodium polyacrylate is added to preferably 400 (four hundred) grams of distilled water of 70-80 degrees Fahrenheit. The mixture is then stirred with for example a whisk, until the mixture becomes a gel. It may take for example 5-6 seconds of stirring to obtain the gel through manual stirring. Next, the gel is allowed to dehydrate, preferably at room temperature (70-80 degrees Fahrenheit) and preferably for 4 (four) days. Next, the evaporated distilled water is replaced. Next, the gel may be placed into a container (e.g., a plastic bottle) with a spout or nozzle ready for use. [0049] FIG. 2 shows a colored gel embodiment 203 of the polyacrylate composition. To make the same fire and smoke prevention gel as described above but colored, preferably 1.5 (one and a half) grams of color agent (e.g., 50% red food dye and 50% yellow food dye) is added first to the distilled water, and the mixture is stirred to mix before adding the sodium polyacrylate. During experimentation, the product was easy to fill into the water bottle with the use of a funnel and chopstick. Once the bottle was filled, it flowed out of the nozzle with a moderate squeeze. [0050] In an alternative embodiment, a flow agent, such as magnesium stearate, may be added. By adding this component to the fire and smoke prevention composition, the composition becomes a somehow heavy viscous liquid, and thus, it has the ability to flow better through pipes, hoses, nozzles (e.g., a medium spray nozzle) and the like. As such, the composition may be used as superior replacement of often toxic and/or hard to clean halon-type compositions, to suppress and extinguish fires, through a similar application (e.g., spraying it on the fire through a medium spray nozzle). Also, in this liquid form, the composition may be easier used to cool, for example, hot metal parts, such as parts subjected to welding. [0051] To make the viscous fire and smoke prevention composition, preferably 100 (one hundred) milligrams of magnesium stearate powder is added first to the distilled water, and the mixture is stirred to mix before adding the sodium polyacrylate. The dehydration and water replacement steps are the same. [0052] To make the viscous fire and smoke prevention composition colored, preferably the 1.5 (one and a half) grams of color agent (e.g., 50% red food dye and 50% yellow food dye) and the 100 (one hundred) milligrams of magnesium stearate powder are both added first to the distilled water, and the mixture is stirred to mix before adding the sodium polyacrylate. The dehydration and water replacement steps are the same. [0053] What follows is a succinct presentation of the experiments conducted to arrive at the compositions and processes disclosed above. [0054] Sodium polyacrylate from a diaper was first mixed and stirred with tap water to form a gel, which was found to be fire resistant. [0055] Next, 10 grams of sodium polyacrylate was extracted from diapers and tests were conducted to find the proper balance of water to sodium polyacrylate to use a fire barrier. It was noticed that all of the mixes started to break down (water separated from gel). [0056] Next, distilled water was used instead of tap water. It was discovered that more distilled water was needed to achieve the same desired composition consistency, than tap water. It was observed that the distilled water mixture was stable, with no visible breakdown. [0057] Next, testing of composition's sealing and fire suppression properties were conducted by using 1/10 scale doors 304 . It was found that the composition was highly fire resistant. However, when deployed into door gaps 306 (on top, sides, and bottom of the door between door, door jambs and floor) small amounts of air pockets formed allowing fire and smoke to penetrate. [0058] Next, different minerals were added to the composition to see if a more gelatinous consistency can be reached. It was found that the composition was highly sensitive to all acids causing immediate breakdowns. [0059] A control batch of the gelatinous composition (distilled water plus sodium polyacrylate mixed as described earlier) was left uncovered for four days causing partial dehydration. Distilled water was then added to compensate for lost water. The composition quickly hydrated, but with no significant air pockets. Testing began again, and the seal around the door, door jambs and floor gap was airtight. No smoke or fire penetrated the gel seal. [0060] Next, a dye was added to help first responders locate trapped victims. Orange was chosen based on its reflective value in the presence of a flashlight. [0061] Next, testing began on the composition to see any limitations that can be foreseen in real life scenarios. The composition was found to be airtight and able to smother a fire in an enclosed room. When a fire in a room with no other substantial access to oxygen (air) other than the doorway, the gel can be deployed around the gaps 306 between the door 305 and door jambs 307 and between the door 305 and floor 307 - a to seal the fire in the room; in other words, to contain the fire in that room. The seal will keep oxygen (air) from entering the room and the result will be the smothering of the fire from lack of oxygen. [0062] Next, while testing a control burn of an untreated door 304 , the composition was used as a fire extinguisher. The results were that less quantity of the composition was needed to extinguish the same amount of fire than water would be needed. [0063] Additional tests and experiments conducted are presented below. [0064] Since it was believed that water is what was keeping the polymer cool to the touch, another experiment was conducted to see if the heat absorption is the same for water as for the mixture/composition (distilled water plus sodium polyacrylate mixed as described earlier). This experiment would eventually show the evaporation rate of water as well as of the composition. [0065] The evaporation test was conducted on both, the composition, then on plain water. The water test was the control. 100 grams of composition was put in a pie pan. 100 grams of water was put in another, same type of pie pan. The heat source was a propane torch held 3 inches away from both items (water and composition). The experiment was to last 20 minutes. [0066] The heat of the pan was to be measured by a digital laser thermometer set in Fahrenheit degrees. The measuring point was the edge of the pie pan. [0067] The results are as follows. In the pie pan with water, the water was completely evaporated after 8 minutes and 34 seconds. The heat of the pan never passed 150 degrees until the 4 minute mark, and then it went up to 223 degrees; by then the water was fully evaporated. [0068] In the pie pan with the gel composition, after 20 (twenty) minutes, the remaining, dehydrated composition weighed only 17 grams. The composition never burned or melted even though at the point it was only 17 grams. The pie pan never passed the 120 degrees mark even after twenty minutes. [0069] The results actually raised the question whether or not the dehydrated composition (after losing the water in this manner) can re-hydrate. 83 grams of distilled water was added to the dehydrated composition in the pan. The dehydrated composition did not reabsorb the water. This finding appears to disprove previous findings that the composition without water would not be affected by direct flame. It turns out that, under certain conditions, it may, by losing the ability to absorb water. The ability of the composition to re-hydrate after a prolonged exposure to fire may be affected. Meaning that the flame, after a prolonged exposure, may break down the sodium polyacrylate. Previous findings showed that, in short flame exposure (10 minutes) or prolonged low level heat exposure (under 550 F for 20 min) the composition will re-hydrate. [0070] The gel composition 203 was tested as a fire repellent several times and it performed equally the same every time. It never, during the 10 minutes test, let any smoke or fire to penetrate the door gaps. [0071] FIGS. 3 a - b show a side perspective view and a front perspective view, respectively, of a 1/10 (one tenth) scale door and frame unit 304 built and used to simulate an actual room door to conduct the experiments described herein. The scale door and frame 304 was used to test how fast the fire would pass through the door gaps 306 and set fire to the opposite side of the door 305 if no fire and smoke prevention gel composition was used to seal the door gaps 306 (between door 304 , door jambs 307 and floor 307 - a ). The results were as follows. [0072] The propane torch flame immediately passed through the door 305 and fully ignited the door 305 on both sides after 2 minutes and 18 seconds. Even though the door 305 had a fire rating of twenty minutes, it did not protect the corners of the door 305 from igniting. The door corner was fully engulfed in fire and the fire was beginning to spread. This was a control test to see how a standard interior door would perform in the same test conditions without the composition. The fire and smoke immediately (within 5 seconds) came through the door gaps 306 and jambs 307 . The fire that penetrated the door 305 caught the edges and corners of the door 305 on fire within three minutes. After five minutes the fire fully engulfed the 1/10 scale door 304 . The door frame (jambs) 307 was also fully engulfed in flames. [0073] Again, after 5 minutes, the 1/10 scale door 304 was fully engulfed in flames. The door 305 temperature was at that time 820 degrees Fahrenheit, and the fire was having large growing flames. The fire extinguishment ability of the gel composition 203 was then tested. About 4 ounces (oz) of the composition 203 that was used as a door sealant (non-magnesium) was thrown at the door. The temperature of the door 305 went from 820 F to 210 F within 5 seconds and it lowered it to 120 F after 2 minutes later, with no further composition added. Additionally, when the test was done with the magnesium composition the results were the same as with the non-magnesium composition. [0074] Thus, the conclusion was that the composition 203 would be equally effective at putting out a fire that already had passed under a door or through door gaps 306 , and thus, at stopping any further advance of the fire into the room. [0075] The gel embodiment 203 of the disclosed composition adhered well to the door jambs 307 on the top and sides of the door 305 , penetrating easily into the ⅛ inch door gaps 306 , without moving. It did not run down or out. It formed a solid seal without any air gaps. Even though the excess material fell off the door jamb 307 , the material in the gap 306 did not move. The bottom door gap 306 filled easily and held its shape up to 2 inches high without running. While dispersing the product, enough mixture flowed to the other side of the door 304 (about 1 inch out). This had a dual purpose. The spill over provided a type of fire proofing for the outside of the door edge and floor. It prevented the floor from burning near the door. It also served as a signal to first responders that someone was in the room and needed help. [0076] Smoke Test [0077] Using a 1/10 scale door 304 in a box, a smoke test was conducted, as briefly described hereinafter. The door gaps 306 (top, left, right and bottom) were sealed with the gel composition 203 by placing the nozzle of the plastic bottle close to the gaps 306 and squeezing the mixture thereto. [0078] FIG. 4 shows smoke 408 used for a fire test with the scale door 304 of FIGS. 3 a - b . Smoke 408 was created by adding 1 oz. wet shredded newspaper to the six ignited briquettes in a pot. Next, the smoke pot was placed on a pie tin in the side of the box that did not have the mixture squirted on the door gaps 306 , to create the smoke as shown in FIG. 4 . [0079] Next, the opening of the box was covered with a shield (e.g., wooden sheet), and towels were placed over the covered opening to seal in the smoke 408 . A stop watch was started. A smoke alarm that was placed on the side that had the mixture was monitored. The test went on the full 10 minutes. The smoke alarm did not go off as no smoke 408 passed through the sealed door gaps 306 . [0080] Fire Test [0081] For the fire test a 1/10 scale door 304 as shown in FIG. 3 a - b in a box was used as well. The door gaps 306 again (top, left, right and bottom) were sealed with the gel composition 203 by placing the nozzle of the plastic bottle close to the gaps and squeezing the mixture thereto. [0082] FIG. 5 shows a propane torch flame 509 held 3 to 4 inches from the bottom of the door 505 and floor gap 506 of the scale door of FIGS. 3 a - b . Simultaneously, a stop watch and a propane torch were started, the propane torch being held 3 to 4 inches away from bottom of the door 505 and floor gap 506 . [0083] At 30 second intervals, the temperature of the gel composition 503 was taken with a laser digital thermometer by aiming the laser at the opposite location of where the fire was being dispensed from. [0084] Temperature readings were also taken of the part of the door that was closest to the mixture, but not covered by it, to see how hot door was. This was done to demonstrate that the heat from fire (propane torch) was intense. [0085] When door 505 started to ignite, the focus of the torch flame 509 was moved slightly to the right, and temperature readings continued to be taken. [0086] This process was continued for 10 minutes. [0087] FIG. 6 is a line graph 610 showing the change in temperature in degrees Fahrenheit over the course of the ten minutes, in seconds, of various parts of the scale door 504 of FIGS. 3 a - b . It was observed that the gel composition 503 did not burn. There was only a slight singe. Although the outside door 504 caught on fire, the composition 503 did not melt nor was there any visible change in its consistency. At any time during the 10 minutes period, including when the torch flame 509 was directly aimed at the door gaps 506 one inch away, no flames penetrated the door gap nor did the product in the gap 506 allow any flame to pass to the other side of the door 505 . When temperature of the door 505 reached 1100 degrees (outside door, where the flame/fire was) and the outside excess gel composition 503 reached 400 degrees, the interior door 505 reached only 110 degrees and the interior gel 503 did not pass 66 degrees (see FIG. 5 ), and again, no flame penetrated. [0088] Also, there was no visible evaporation from the gel composition 503 and anything that the gel composition 503 came in contact with did not burn. Even after the 10 minute mark, the interior door 505 showed no signs of fire. [0089] The same smoke and fire tests were also conducted for other mixtures. It should be noted the superiority of the disclosed composition. [0090] FIG. 7 shows Table 1 summarizing the results and observations of smoke and fire tests conducted for various other mixtures. [0091] FIG. 8 shows Table 2, listing the time in seconds that it took for fire or smoke to penetrate to the other side of the door within a 10 minute time frame of the smoke and fire experiments. 600+ seconds indicate that no penetration occurred within 600 seconds (i.e., 10 minutes). Again, it should be noted the superiority of the disclosed composition. [0092] FIG. 9 shows a bar graph 911 depicting the data from Table 2 of FIG. 8 . It should be noted the superior performance of the disclosed polymer. [0093] Carpet Experiment [0094] Another experiment was conducted, using carpet because many rooms in a house are carpeted. The purpose was to see if the fire would burn the carpet underneath the door bypassing the gel composition. [0095] FIG. 10 shows the 1/10 scale door 1005 of FIGS. 3 a - b in a box, with a piece of carpet 1013 stapled and glued to the floor (i.e., the upper side of the bottom of the box 304 as shown by 307 - a of FIG. 3 ) of the box 304 . Again, a torch flame 509 and a 1/10 scale door in a box was used as shown in FIGS. 3-4 . [0096] Surprisingly, the results were the same as in the fire test described earlier with no carpet 1013 . An added benefit of the disclosed gel composition 1003 is that the carpet 1013 that had the gel composition 1003 on it was unchanged. When the gel composition 1003 was removed from the carpet 1013 , it left no residue on the carpet 1013 . The carpet 1013 that was under the gel composition 1003 was not wet to the touch once the gel 1003 was removed. The carpet 1013 under the gel composition 1003 was protected from the fire by denying oxygen to the advancing fire. [0097] Thus, a nontoxic, flame and smoke resistant mixture 1003 that is easy to use and have a long shelf life was disclosed herein. The disclosed composition, even in the gel form 1003 , can be easily squirted out of plastic water bottle for example. It is watery enough to be injected into door gaps 306 and firm enough to keep its shape and not melt when exposed to direct flame from a propane torch 509 . It is an effective sealant for smoke and fumes as well. The disclosed composition may be a lifesaving tool by injecting it into door gaps 306 , thus, (in the gel form) sealing the door from advancing fire and smoke. When a bright colored dye is added to the mixture, it works as a signal to rescuers that there are people inside the room who need to be saved. When a flow agent is added to the mixture as described earlier, it may be sprayed as a fire extinguisher. [0098] In another exemplary embodiment, a material for a fire shelter, for example, with the fire and smoke prevention composition incorporated therein is provided. [0099] To make a hydrated polyacrylate fire blanket, the following process may be followed. Polyacrylate filling may be wrapped with cheesecloth or any other suitable similar material. The polyacrylate filling may be encased by the cheesecloth or other material by stitching them together with, for example, cotton string, or any other suitable material. The blanket may then be activated by hydration with water by for example pouring water over the blanket or submerging the blanket in water or any other suitable method. Sodium polyacrylate may also be suspended in loose fibers of any suitable material and water soluble glue may be used to make small compartments, such that the sodium polyacrylate crystals are equally distributed throughout the material to be used as a blanket or fire shelter or other fire and smoke prevention device. The blanket or fire shelter or other device may then by activated by hydration with water using any method suitable. The material with sodium polyacrylate crystals may be, for example, carried by any person while the material is unhydrated so as to decrease the overall weight of the object, and then activated by hydration when its use becomes necessary. For example, firefighters may carry dry polyacrylate fire shelters, and if the use of a fire shelter becomes necessary, the firefighters may, for example, use the liquid on their packs to quickly activate the polymer and seek protection inside of the hydrated polyacrylate fire shelter. [0100] What follows is a succinct presentation of the experiments conducted to arrive at the compositions and processes disclosed above. [0101] FIG. 11 a shows a fire shelter frame 1114 built using pine wood strips to simulate actual fire shelters 101 in the experiments described herein. Five fire shelter frames 1114 were built. Two 8″ wood strips were parallel, 4″ apart, and stapled together. Two 4″ wood strips were used to connect the 8″ strips, forming a rectangle. Another rectangle was made in the same manner, and the two rectangles were connected by stapling four additional wood strips, forming a box 1114 . [0102] FIG. 11 b shows an example of a dry polyacrylate blanket 1115 used for the experiments described herein. A 14 inch by 40 inch cheesecloth was used, and polyacrylate filling (not shown, underneath the visible cloth of FIG. 11 b ) was placed on top. The cloth was folded over the polyacrylate filling and stitched to form a 14 inch by 20 inch blanket 1115 . [0103] A dry polyacrylate fire shelter with aluminum foil as a reflective shield was used to perform a convection test. [0104] FIG. 11 c shows the polyacrylate blanket 1115 of FIG. 11 b wrapped around the fire shelter frame 1114 of FIG. 11 a . The blanket 1115 was placed lengthwise, and the wood frame 1114 was placed widthwise on top of the blanket 1115 . An extra-large room temperature raw egg 1116 was placed in the middle of the frame 1114 . A thermometer probe 1117 was placed alongside the egg 1116 , making sure that the wire stuck out of the frame 1114 . [0105] FIG. 11 d shows the blanket and fire shelter frame of FIG. 11 c wrapped in aluminum foil 1118 to create a fire shelter 1120 , with a thermometer probe 1117 inside of the frame 1114 . The foil was placed with its shiny, reflective side down on the table. Next, the frame 1114 wrapped in the blanket 1115 was placed on top, and the foil 1118 was wrapped around the frame 1114 and blanket 1115 , with its shiny, reflective side facing outwards, allowing the wire of the thermometer probe 1117 to protrude from the wrapping, creating a dry polyacrylate fire shelter with a reflective shield 1120 . The thermometer was programmed with an alarm to read 130 degrees Fahrenheit maximum, to gauge when physical harm might begin to occur to an individual. The fire shelter 1120 was placed in an oven (not shown), preheated to 550 degrees Fahrenheit. The temperature inside of the fire shelter 1120 was recorded every minute for 30 minutes. At the end of the 30 minutes, the fire shelter 1120 was removed from the oven, and the aluminum foil 1118 and blanket 1115 were unwrapped. A laser thermometer (not shown) was used to verify the reading of the thermometer probe 1117 . The egg 1116 was removed from the fire shelter 1120 and placed in a pie tin, and cut in half lengthwise. [0106] The starting temperature inside of the fire shelter 1120 was 67 degrees Fahrenheit. The heat transfer occurred immediately. The temperature rose at a very high rate, reaching 136 degrees Fahrenheit in 8 minutes (see FIG. 12 a ). This would be considered deadly in a wildfire. The average rate of increase was ten degrees per minute. At 15 minutes, the smell of burning cloth filled the kitchen where the experiment was taking place. The temperature was 191 degrees, which meant that the heat convection temperature was much higher. After the 30 minutes, the internal temperature was 255 degrees Fahrenheit. Upon removal of the fire shelter 1120 from the oven, it was observed that the framework 1114 had sap leaking out of a knot hole. The laser thermometer reading where the polyacrylate 1115 was touching the foil 1118 was 354 degrees Fahrenheit, the internal polyacrylate 1115 facing the egg 1116 was 288 degrees Fahrenheit, and the egg 1116 when cracked open was 185 degrees Fahrenheit on the inside. The egg 1816 - a was cooked all the way through (see FIG. 18 a ). [0107] The overall performance of the dry polyacrylate 1115 in the test was observed to be low. The main ingredient of the insulation in the shelter 1120 was the air pockets in the polyacrylate blanket 1115 . The foil 1118 wrapped around the blanket 1115 trapped air pockets, giving some protection from the heat. Although the fire shelter 1120 reached 136 degrees Fahrenheit in 8 minutes, it still offered some protection for a short-term situation. The convection heat of an oven will penetrate through aluminum foil 1118 quickly as the foil 1118 absorbs the heat and converts it into radiant heat. The heat then passes through the cloth's 1115 air pockets, passing it to the inner shelter and then converting it back into convection heat. What occurs is the air trapped in the shelter 1120 in the air gap begin to rotate, creating current spreading the hot air in the top and bottom of the shelter. The air gap provides substantial protection, about a 40 degree difference between the interior surface temperature of the shelter and the egg 1116 surface temperature, solely due to the air gap. Since the conduction heat passing through the cloth 1115 is broken up by the air gap, the energy has to then be converted back to convection, and this lowers the overall temperature. [0108] A hydrated polyacrylate fire shelter 1123 with aluminum foil as a reflective shield was used to perform a convection test. A fire shelter frame 1114 as shown in FIG. 11 a was used, and a polyacrylate blanket as shown in FIG. 11 b was used. The experimental set up was the same as described above for the dry polyacrylate fire shelter with a reflective shield 1120 , with the following additional steps. Before wrapping with foil 1118 , the blanket 1115 was wrapped around the fire shelter frame 1114 and then stitched together to prevent it from opening up around the frame, and then placed in a large mixing bowl. Next, water 1119 was poured over it. [0109] FIG. 11 e shows a fire shelter frame wrapped with a polyacrylate blanket 1123 being hydrated with tap water 1119 poured over it. 71.1 oz of tap water 1119 was poured over the polyacrylate 1123 . Then, after wrapping the fire shelter frame 1114 and blanket 1115 with foil 1118 , with its shiny, reflective side facing outwards, the procedure was the same as the previously described experiment. After removing the fire shelter 1120 from the oven, the foil 1118 was unwrapped and the stitching on the blanket 1115 was cut in order to verify the temperature inside of the frame and to remove and cut the egg 1116 . [0110] The starting temperature inside the fire shelter 112 was 67 degrees Fahrenheit. There was no change in temperature observed until the fourteenth minute. From there, the temperature rose by one degree every four minutes. At 22 minutes, the rise in temperature became one degree every two minutes. The last four minutes of the experiment, the rise in temperature became one degree every minute. At the end of the 30 minutes, the temperature was 78 degrees Fahrenheit (see FIG. 12 a ). Unlike the dry polyacrylate experiment, there was no noticeable odor. After removal of the fire shelter 1120 from the oven, the outside temperature of the polyacrylate 1115 touching the foil 1118 was 146 degrees, the temperature of the polyacrylate 1115 facing the framework 1114 was 90 degrees, and the outside of the egg 1116 was 78 degrees. The internal temperature of the egg 1116 was 77 degrees. When cracked open, the egg 1816 - b was observed to be raw (see FIG. 18 b ). [0111] The observed slow rise in temperature in this experiment was due to the Second Law of Thermodynamics, stating that heat will flow from a higher temperature to a lower temperature until equilibrium is reached. Because of the density of the water in sodium polyacrylate's polymer cells, the slow rise in temperature showed that heat takes a much longer time to travel through it. Heat can travel faster through air cells or pockets since air much less dense than water, and less energy may be spent so that more heat can pass through. Another reason for the heat taking longer to pass through the hydrated polymer is that there is a layering effect. Heat must raise the temperature in each individual pocket before passing onto the next pocket through conduction heat. When the polyacrylate polymer 1115 is hydrated 1123 , it forms thousands of cells, which form individual layers. The sodium that surrounds the hydrated polymer cells act similarly to a foil wrapping, providing another layer of insulation. Thus, the density of the water 1119 gives insulation properties, the individual cells of water formed by the polymer makes many layers, and the sodium keeps the water 1119 from dehydrating from the polymer. [0112] A U.S. Forestry fire shelter blanket 1121 was used to perform a convection test. The U.S. Forestry fire shelter was cut to form a 14 inch by 20 inch sample blanket, which was wrapped around a fire shelter frame 1114 containing an egg 1116 and thermometer probe 1117 and placed in an oven. The experimental procedure then was the same as the above described experiment with a dry polyacrylate blanket 1115 . [0113] The starting temperature inside of the fire shelter was 67 degrees Fahrenheit. After one minute, it rose to 118 degrees, roughly one degree per second. At one minute and 13 seconds, the internal temperature reached 130 degrees Fahrenheit, the temperature at which physical harm might occur to an individual. The temperature rise remained steady, at a rate of 1 degree for every 2-3 seconds, with no temperature spikes. The smell of burning wood and burning glue filled the kitchen. The maximum temperature of 390 degrees Fahrenheit was reached on the thermometer probe before the 15 minute mark. No more reliable data could be collected, so the experiment was stopped at this point (see FIG. 12 a ). After removal from the oven, the temperature of the egg 1816 - c was 221 degrees Fahrenheit and fully cooked (see FIG. 18 c ), and the shell was cracked. [0114] The results of the U.S. Forestry fire shelter 1121 convection test showed the importance of having an additional form of insulation. In the oven, the shelter quickly rose to the maximum temperature that the thermometer probe could measure, 390 degrees Fahrenheit, in under 15 minutes, and the experiment had to be stopped prematurely. Upon removal from the oven, it was observed that the shelter 1121 had begun to come apart. The glue which held the two foil sheets and silica weave together had failed, and during the test, the smell of burning glue had been observed. [0115] FIG. 11 f shows that the silica weave 1122 of the U.S. Forestry (U.S.F.) fire shelter 1121 had turned a light brown color, indicating that it had burned. In researching the prior art, it was found that silica weave 1122 can withstand 2400 degrees Fahrenheit before breaking down. Therefore, it was concluded that it was the glue that had failed. The glue of the U.S.F. fire shelter 1121 was known to have failed at 500 degrees Fahrenheit previously, and these test results confirmed this finding. Upon removing the silica weave 1122 from the shelter 1121 , it was observed under a magnifying glass that the weave 1122 was transparent and its fibers had open space between them. Previous experiments disclosed herein using the fire and smoke prevention composition showed that the best way to keep fire and smoke from penetrating a door jamb or gap was to fill it with something that has a strong bond with itself (see FIG. 5 , FIG. 10 ). The silica weave 1122 of the U.S.F. fire shelter 1121 depended solely on the foil to complete its air pocket or air cell. As in the previous experiment which relied on air pockets, the heat passed through quickly. The U.S.F. fire shelter performed worse than the dry polyacrylate cloth 1115 , which may have been due to the size of the air pockets. The polyacrylate cloth had more air pockets, because it was thicker than the U.S.F. fire shelter 1121 material. Additionally, because the U.S.F. fire shelter 1121 had two sheets of aluminum, the transfer of heat through conduction was much greater, since metal conducts heat better than cloth. [0116] FIG. 12 a shows Table 3 summarizing the results of the 30 minute convection tests using the hydrated polyacrylate 1123 , dry polyacrylate 1115 , and U.S. Forestry 1121 fire shelters. [0117] FIG. 12 b shows a line graph 1224 illustrating the results of the 30 minute convection tests using the hydrated polyacrylate 1123 , dry polyacrylate 1115 , and U.S. Forestry 1121 fire shelters. It should be noted the superior performance of the hydrated polyacrylate fire shelter 1123 . [0118] To test a hydrated polyacrylate fire shelter with no reflective shield, the experimental procedure was followed for the hydrated polyacrylate fire shelter described above, but without the aluminum foil. [0119] The starting temperature inside the fire shelter was 71 degrees Fahrenheit. Unlike the experiment with a reflective shield, the polyacrylate 1123 had a steady climb in temperature. The temperature rose between 1-2 degrees every minute until it reached 120 degrees Fahrenheit. There were no spikes or plateaus as there were in other experiments. At the end of the experiment, the temperature of the outside of the polyacrylate 1123 was 214 degrees, the temperature of the polacrylate facing the egg was 152 degrees, and the egg was 119 degrees. The egg 1816 - e was observed to have a soft boiled texture, with mostly uncooked egg whites mixed with some cooked egg whites, and runny yolk (see FIG. 18 e ). [0120] These results showed that the foil or reflective shield does delay the heat transfer. With the foil, the hydrated polacrylate 1123 started to heat up at the 14 minute mark. Without the foil, the heat began rising immediately. It was a slow, steady rise, unlike the experiments using the dry polyacrylate 1115 or the U.S.F. 1121 fire shelters, which showed a steep rise in temperature (see FIG. 12 a ). There was a nearly 50 degree climb in temperature; however, the end result of the experiment still suggested a survivable condition at 120 degrees after 30 minutes. Foil was found to work as a reflective barrier, but not a conduction barrier. It does not retain heat at all once the heat source is removed. The foil 1118 may not be keeping the heat out as much as it is keeping the cool hydrated polymer 1123 from heating up through direct convection heat. Thus, this test shows how the reflective insulator delays the heat by providing another barrier. Since the foil reflects some heat, it also reflects the cooler temperature of the hydrated polymer into itself. Without the foil, the hydrated polymer immediately started its temperature rise. Although at a much slower rate, it still rose steadily, possibly due to the convection heat turning into conduction heat much quicker without the reflective insulation. [0121] FIG. 13 a shows Table 4 summarizing the results of the experiments testing the hydrated polyacrylate 1123 fire shelter with and without a reflective shield. [0122] FIG. 13 b shows a line graph 1325 illustrating the results of the 30 minute test of the hydrated polyacrylate with and without a reflective shield. It should be noted the superior performance of the hydrated polyacrylate with a reflective shield. [0123] To test open flame radiation with a U.S. Forestry fire shelter, a 14 inch by 18 inch sheet was cut from a U.S. Forestry fire shelter to make a sample blanket. One extra-large room temperature raw egg was placed in the middle of the sheet, with a thermometer probe. The fire shelter blanket was wrapped around the egg and probe to make an 11 inch by 4 inch by 3 inch shelter. [0124] FIG. 14 a shows a U.S. Forestry fire shelter 1426 blanket wrapped around an egg and thermometer probe, with a lit propane torch 1409 applying flame about four inches from the fire shelter 1426 . The experiment proceeded for 15 minutes, with temperature readings being recorded every minute. The shelter 1426 was then opened and the egg was cut in half. [0125] The starting temperature inside of the fire shelter 1426 was 82 degrees Fahrenheit. There was an approximately 1 inch air gap separating the egg from the inner lining of the U.S.F. fire shelter. The foil immediately bubbled and separated exposing the silica weave 1122 , which turned a glowing red. After one minute, the temperature reached 123 degrees. After three minutes, it reached 222 degrees, at a steep incline. At four minutes, it reached 236 degrees and it plateaued until the eighth minute, when it rose to 239. By the eleventh minute, it reached 244 degrees and remained there until the end of the 15 minute test. When the wrapping was opened, the egg shell was cracked, with egg white seeping out. The egg shell was 140 degrees and the internal egg temperature was 103 degrees. There was a very slight amount of egg white that was cooked; otherwise, the egg 1816 - g was raw (see FIG. 18 g ). [0126] The results of this test helped to understand how a U.S.F. fire shelter 1426 would perform under extreme direct heat from a propane torch 1409 . The torch flame 1409 can reach a temperature of 2400 degrees Fahrenheit. The shelter 1426 was built into a small scale shelter, but with the same principle of how a firefighter may use it. As the fire was directed onto the foil 1426 , the foil 1426 quickly flaked away. This supported the research that was done on the foil, which suggested that foil may only be able to reach 1400 degrees before it melts. After the foil was flaked away, the flame 1409 was directly aimed at the silica weave 1122 from four inches away. The weave 1122 immediately glowed red under the direct flame, and the internal temperature of the wrapping quickly rose to 123 degrees after one minute and continued to rise until 244 degrees was reached after 11 minutes. The temperature remained the same until the end of the 15 minute test. The observation of the exposed silica weave 1122 glowing but not burning led to the suggestion that the flame was under 2400 degrees, which would cause a breakdown of the silica weave at its melting point. [0127] As previously noted, the silica weave 1122 was very loose in its construction, with many air gaps, so that heat transferred easily into the inner shelter. The next observation is why the temperature rise stopped at 244 degrees. It is known that the internal temperature of the U.S.F. fire shelter can reach 200 degrees, which supports the idea that the silica weave has an ability to reflect and insulate very high radiation heat, but not high convection heat. [0128] To test open flame radiation with a hydrated polyacrylate fire shelter, aluminum foil was laid with its shiny, reflective side down, and a polyacrylate blanket was placed on top. 6 oz of water was poured evenly over the blanket. An extra-large room temperature raw egg was placed in the middle of the blanket, alongside a thermometer probe. The blanket and foil were wrapped around the egg and probe, to make an 11 inch by 4 inch by 3 inch fire shelter. [0129] FIG. 14 b shows a propane torch 1409 lit and the flame held about 4 inches away from a hydrated polyacrylate fire shelter 1427 . The experiment proceeded for 15 minutes, with temperature readings being recorded every minute. The shelter 1427 was then opened and the egg was cut in half. [0130] The starting temperature inside of the fire shelter 1427 was 82 degrees Fahrenheit. The foil burned away immediately as in the previous experiment. However, while the hydrated polymer blanket interior did char slightly, no other breakdowns occurred and there were no other visible effects. During the 15 minute test, the temperature inside the shelter 1427 did not rise. These results supported the findings of the convection heat test. When the egg 1816 - f was removed and cracked open at the end of the experiment, it was observed to be completely raw and still at the same temperature of 82 degrees (see FIG. 18 f ). [0131] These results supported the idea that the hydrated polymer reflects the direct heat from the flame because of the sodium that surrounds the individual cells. Although there was some charring to inidicate that the polymer did break down and burn, it also formed an insulation with that resulting carbon, which may be what stopped the polymer from continuing to break down. Previous experiments had shown that in longer experiments, the polymer may break down. [0132] FIG. 15 a shows Table 5 summarizing the results of the experiments testing open flame radiation on a hydrated polyacrylate fire shelter and a U.S. Forestry fire shelter. [0133] FIG. 15 b shows a line graph 1528 illustrating the results of the 15 minute open flame radiation tests using a hydrated polyacrylate 1427 and U.S.F. 1426 fire shelter. It should be noted the superior performance of the hydrated polyacrylate fire shelter 1427 , which did not allow any change in temperature on the inside. [0134] To test the endothermic response of water with no reflective shield, a raw egg was placed in a Corningware bowl. [0135] FIG. 16 a shows a raw egg in a Corningware bowl completely submerged in 24 oz of tap water 1619 , with a thermometer probe also placed in the water. The starting temperature was recorded. Next, the bowl was placed into an oven. The experiment proceeded for 30 minutes, with temperature readings being recorded every minute. The bowl was then removed from the oven and the egg was cut in half. [0136] The starting temperature of the egg in water was 73 degrees Fahrenheit. There was an overall steady climb in temperature of 5-8 degrees per minute with no heavy spikes or plateaus. Once the experiment had proceeded for 20 minutes, the temperature reached 210 degrees and the water had a steady boil. This continued until the end of the 30 minutes. Upon removal of the egg 1816 - i , it was observed that it had been hard-boiled (see FIG. 18 i ). [0137] These results showed that the water without a foil barrier or an air gap had a quick and steady increase in temperature. The boiling point of the water was reached at the 20 minute mark. [0138] To test the endothermic response of water with a reflective shield, a raw egg 1616 was submerged in 24 oz of water 1619 in a Corningware bowl 1629 with a thermometer probe 1617 . [0139] FIG. 16 b shows a bowl 1629 wrapped in aluminum foil 1618 with the shiny, reflective side facing outwards. The starting temperature was recorded. Next, the wrapped bowl 1629 was placed into an oven. The experiment proceeded for 30 minutes, with temperature readings being recorded every minute. The bowl 1629 was then removed from the oven and the egg 1616 was cut in half. [0140] The starting temperature was 73 degrees Fahrenheit. There was a steady climb in temperature during the experiment, generally 2-3 every minute. It reached 152 degrees at the end of the 30 minutes, and did not reach the boiling point of 210 degrees during the test even though the oven temperature had been set to 550 degrees. When the bowl 1629 was removed from the oven and the foil was pulled back, small bubbles of air on the side of the bowl 1629 were observed, although the water had not begun boiling. When the egg 1816 - h was removed and cut into, its internal temperature was 150 degrees. Parts of the egg were still soft, and overall was mostly cooked (see FIG. 18 h ). [0141] These two endothermic response test results strongly suggested that a reflective shield does form an insulation barrier. The foil shield worked well to reflect some heat and delay the second endothermic law. Additionally, although the foil did act as a shield, it is likely that the air gap that formed in the area between the foil and the water played a greater role in these results. The two tests described herein suggested strongly that having a foil barrier and maintaining an air gap are beneficial in insulation. [0142] FIG. 17 a shows Table 6 summarizing the results of the experiments testing the endothermic response of water with and without a reflective shield. [0143] FIG. 17 b shows a line graph 1730 illustrating the results of the experiments testing the endothermic response of water with ( FIG. 16 a ) and without a reflective shield ( FIG. 16 b ). It should be noted the superior performance of the reflective shield ( FIG. 16 a ) in maintaining a lower temperature of water 1619 . [0144] To test thermal conductivity of a hydrated polyacrylate blanket with a reflective shield and with no air gap, a raw egg and hydrated polyacrylate blanket were used as in previously described experiments, but no fire shelter frame was used. A sheet of 16 inch by 14 inch aluminum foil was laid out and a 3 inch by 12 inch polyacrylate blanket was laid on top of the foil. Room temperature water was poured over the polyacrylate blanket. A raw egg was placed in the middle of the blanket and wrapped with the blanket and foil with the foil's shiny, reflective side facing outwards. This wrapping was placed in an oven for 30 minutes, and then removed and cut in half. [0145] The starting temperature inside of the wrapping was 71 degrees Fahrenheit. After the 30 minutes, the temperature of the outside of the foil was 92 degrees, the temperature of the polyacrylate touching the foil was 175 degrees, and the temperature of the polymer facing the egg was 160 degrees. The egg's temperature was 140 degrees. When the egg 1816 - j was cracked, it was observed to look like a soft-boiled egg, with some runny egg white and some runny yolk (see FIG. 18 j ). There was observed to be a large amount of heat transference between the foil and the polyacrylate blanket. [0146] These results strongly suggested the importance of an air gap in the fire shelter. There was a nearly 70 degree rise in temperature compared to the test that was performed with an air gap, using the fire shelter frame with blanket wrapped around the frame (see FIG. 12 a ), which rose only 11 degrees. In analyzing the results, it was observed that the air gap works by breaking up the conductive heat, meaning that contact between two objects of different temperatures will follow the Second Law of Thermodynamics. The object of greater temperature will pass heat to that of the lesser temperature. With contact, the heat transfer is very effective. Even though the polymer is an effective insulator, it still passes some conductive heat through the contact of polymer cells, which may be why the insulator passed the heat onto the egg. With an air gap, heat may pass onto the inner shelter no matter what insulator is in place. [0147] FIGS. 18 a - j show the status of the eggs used after each experiment. It should be noted the superiority of the conditions that resulted in uncooked, raw eggs. [0148] To test the shiny and dull sides of aluminum foil for their insulation value, two potatoes (not shown) of nearly the exact same weight, length, and girth were used. The temperatures of the potatoes were taken and each were wrapped with enough foil to cover the potatoes in one layer of foil. One potato was wrapped with the foil's shiny, reflective side facing outwards, and the other was wrapped with the foil's dull side facing outwards. Both wrapped potatoes were placed in an oven that had been preheated to 400 degrees Fahrenheit. The potatoes were placed in the oven for 30 minutes. The potatoes were then removed and a laser thermometer was used to measure the outside temperature of the aluminum foil of both wrapped potatoes. A thermometer probe was then used to measure the internal temperatures of both potatoes by inserting the probe one inch deep into the potatoes. The experiment was repeated for other sets of exact same weight potatoes. [0149] The starting temperature of the potatoes was 72 degrees Fahrenheit. After the 30 minutes, the potatoes were removed from the oven and their temperatures were measured using a laser thermometer. [0150] FIG. 19 shows a bar graph 1931 illustrating the rests of the aluminum foil shiny and dull side comparison test. When the test was performed using sets of potatoes having different weights, the temperature of the potato that had the dull side of the foil facing outwards was consistently approximately 5 degrees higher than that of the potato that had the shiny side of the foil facing outwards. [0151] It may be advantageous to set forth definitions of certain words and phrases used in this patent document. [0152] All temperature degrees in this disclosure are Fahrenheit degrees, unless otherwise indicated. All length units are inches, unless otherwise indicated. All eggs were extra-large and raw, and at room temperature at the start of each experiment. All experiments using an oven had the oven preheated to 550 degrees Fahrenheit unless otherwise indicated. [0153] The terms “include” and “comprise,” as well as derivatives thereof, mean inclusion without limitation. The term “or” is inclusive, meaning and/or. The phrases “associated with” and “associated therewith,” as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like. [0154] Although specific embodiments have been illustrated and described herein for the purpose of disclosing the preferred embodiments, someone of ordinary skills in the art will easily detect alternate embodiments and/or equivalent variations, which may be capable of achieving the same results, and which may be substituted for the specific embodiments illustrated and described herein without departing from the scope of the invention. Therefore, the scope of this application is intended to cover alternate embodiments and/or equivalent variations of the specific embodiments illustrated and/or described herein.

1a

TECHNICAL FIELD OF THE INVENTION [0001] The present invention relates to an apparatus and system for performing surgery, and in particular, to a surgical anchor for hands-free operation and control of medical instruments inside a body cavity. BACKGROUND OF THE INVENTION [0002] This application claims priority to U.S. Provisional Application Ser. No. 60/526,700, filed Dec. 2, 2003; and U.S. Provisional Application Ser. No. 60/536,765, filed Jan. 15, 2004. Without limiting the scope of the invention, its background is described with respect to surgical procedures, and in particular, laparoscopy. [0003] Compared with open surgery, laparoscopy results in significantly less pain, faster convalescence and less morbidity. However, eye-hand dissociation, a two-dimensional field-of-view and fixed instrumentation with limited degrees of freedom contribute to a steep learning curve and demanding dexterity requirements for many laparoscopic procedures. One of the main limitations of laparoscopy is the fixed working envelope surrounding each trocar, often necessitating placement of multiple ports to accommodate changes in position of the instruments or laparoscope to improve visibility and efficiency. The placement of additional working ports contributes to post-operative pain and carries a small risk of bleeding or adjacent organ damage. What is needed is a system that reduced the required number of ports. [0004] One such system is disclosed in U.S. Pat. No. 5,352,219, issued to Reddy. A two-part modular tool and method is taught for use in conjunction with laparoscopic techniques by enabling tools to be manipulated within a body cavity through holes created by a shank. The two-part tool has an instrument head initially inserted through a laparoscopic port and an acuminate shaft that intra-corporeally attaches to the instrument head. The instrument head is then manipulated through the needle hole at the site of desired use. The instrument head may be any tool configuration useful in surgical procedures that can be miniaturized to pass through a laparoscopic port. Problem associated with the invention are that the tool has a limited area of use, the tool is limited by the strength and length of the needle and the tool is limited to the site of insertion. The limited two and three dimensional field of view within the body cavity may cause insertion of the needle at the wrong location, requiring additional insertions of the shank, thereby increasing greatly the number of skin punctures and increased morbidity from multiple punctures. Furthermore, in order the manipulate the tool, the needle(s) must not only be of a diameter and strength to make the tool useful, without the benefit of a trocar the tool damages the lining at the site of puncture every time the tool is actuated. SUMMARY OF THE INVENTION [0005] In order to provide for greater flexibility of endoscopic viewing and instrument usage and to further reduce morbidity, a laparoscopic surgical anchor system has been developed around an internal platform capable of supporting various laparoscopic tools that is secured via a pin or needle to the abdominal wall. The pin is able to provide electrical, mechanical, pneumatic and other power or support externally to the surgical anchor located internally. [0006] More particularly, the present invention includes a device for manipulating a surgical tool at an intended manipulation location, e.g., in a confined or inaccessible space wherein the surgical anchor has at least one opening that provides a catch for a pin and at least one anchor point for the surgical tool. The pin may be, e.g., a needle that is threaded, beaded, knotched and the like for insertion and self-locking into the catch at the opening in the surgical anchor. The pin may even provide electrical power, pneumatic power, communication or even light to the surgical tool attached to the surgical anchor. [0007] Surgical tools for use with the present invention may be attached to the surgical anchor by a universal joint and may even be, e.g., completely or partially self-actuating, controlled manually or magentically. Every type of surgical tool that has been reduced in size for entry into a body cavity via a trocar may be attached to the surgical anchor, e.g., a camera, a retractor, a paddle, a hose, a cutting tool, a light, a hook, a net or an anchor provided the tool includes an attachment point to the surgical anchor. The surgical tool may also include a drawstring for removing the surgical tool. In one embodiment, the surgical anchor and the surgical tool are of unitary construction and inserted through a trocar at the same time, e.g., anchored surgical camera. The surgical anchor may be made of one or more materials, e.g., surgical plastic, stainless steel, aluminum, nylon, polyester, and mixtures and combinations thereof. [0008] In another embodiment, the surgical anchor include at least one opening, wherein the opening provides a catch for a pin, at least one anchor point for a surgical tool and a ferrous material disposed in or about the surgical anchor. The ferrous material may be disposed on or about the surgical anchor or it may even be a wire, wires, a wire bundle and the like and may be, e.g., oriented along the length of the surgical anchor in one or more orientations. The ferrous material on the surgical anchor may be used to attract a magnet positioned externally from the surgical anchor (within a body cavity), wherein manipulation of the magnet directs movement of the anchor within the body cavity or vice verse, that is, the surgical anchor is magnetic and a ferrous material or another magnet is external to the body cavity. In one embodiment the magnet is, e.g., a permanent magnet. [0009] Yet another embodiment of the present invention is a remotely operated surgical device that has a generally tubular anchor with at least one opening, wherein the opening provides a catch for a pin, at least one anchor point for a surgical device and a surgical device anchored to the anchor point of the anchor, wherein the surgical tool can operate independently of a hand-held laparoscopic tool within a confined space at distances greater than, e.g., 20 centimeters. [0010] Yet another embodiment of the present invention is a general purpose surgical platform that includes an anchored surgical device (e.g., magnetically anchored) that has a linear ferrous portion that extends along at least one length of the surgical device and an intraabdominal tool anchor point, wherein the platform allows for hands-free operation within a limited surgical envelope. Generally, the magnetically anchored surgical device will collapse to a cylindrical diameter of between about 5, 8, 12 and about 15 mm for insertion through a trocar. The anchored surgical device may also include an opening with a catch for semi-permanent anchoring of the device. An intraabdominal tool may be attached prior to or after insertion of the platform into the body cavity at the surgical anchor point, wherein the intraabdominal tool is a camera, a retractor, a scissors, a paddle, a hose, a cutting tool, a light, a hook, a net and the like. The anchor may also include one ore more suction cups for additional attachment strength. [0011] The surgical anchor may further include a ferrous insert, coating or combination thereof that permits manipulation (position and orientation) of the anchor after insertion through a trocar internally without the need for permanent tools or connections. The surgical anchor may also include magnets or suction cups that increase the control for positioning and strength of attachment in a hands-free system. After insertion into, e.g., an abdominal cavity, the surgical anchor and tools attached thereto remain surgeon-controlled via, e.g., external magnetic couples on the patient's abdomen. Using the surgical system disclosed herein, instruments, e.g., miniature endoscopic cameras, lights, retractors, scalpels, and the like may be used to augment, e.g., the surgical field of view, surgical precision and anchoring. [0012] Accordingly, the present inventors have recognized that the field of laparoscopic surgery needs a method and apparatus that enables a surgeon to manipulate the position and orientation of one or more instruments within a human body without the necessity for multiple trocars. To provide for greater flexibility of endoscopic viewing and instrument usage and to further reduce morbidity, the inventors have developed a novel laparoscopic system that allows for unrestricted intra-abdominal movement of an endoscopic camera and surgical instruments without additional port sites. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The accompanying figures, in which like reference numerals refer to identical or functionally-similar elements throughout the separate views and which are incorporated in and form part of the specification, further illustrate the present invention and, together with the detailed description of the invention, serve to explain the principles of the present invention. [0014] FIG. 1A is an isometric view, and 1 B, 1 C are cross-sectional views of the surgical anchor of the present invention; [0015] FIGS. 2A, 2B and 2 C are a bottom, side and top view of a surgical anchor, respectively; [0016] FIG. 3 is a graph of simulated and empirical force versus gap results using magnets for controlling the positioning of a surgical anchor; [0017] FIG. 4 is a magnetic field simulation for computer generated flux paths for a single-stack magnet configuration; [0018] FIGS. 5A and 5B are a side and a bottom view, respectively, of a trocar cable and light port for use with the present invention, respectively; [0019] FIG. 6A is a top view of a dual-magnet, 6 B is cross-sectional view of the dual magnet, and 6 C is a cross-sectional view combining the surgical anchor and the dual magnet for use with the present invention; [0020] FIG. 7 is an isometric view of an anchored paddle retractor for use with the present invention; [0021] FIG. 8 is an isometric view of another embodiment of an anchored tool with a pneumatic piston; and [0022] FIG. 9 is an isometric view of another embodiment of an anchored tool with both a pneumatic piston and an electrical actuator. DETAILED DESCRIPTION OF THE INVENTION [0023] The novel features of the present invention will become apparent to those of skill in the art upon examination of the following detailed description of the invention. It should be understood, however, that the detailed description of the invention and the specific examples presented, while indicating certain embodiments of the present invention, are provided for illustration purposes only because various changes and modifications within the spirit and scope of the invention will become apparent to those of skill in the art from the detailed description of the invention and claims that follow. [0024] The description of laproscopic surgery is set forth to demonstrate the use of the present invention in one type of surgery and is not intended to be exhaustive or to limit the scope of the invention. Many modifications and variations are possible in light of the teachings described herein without departing from the spirit and scope of the following claims. It is contemplated that the use of the present invention can involve components having different characteristics. It is intended that the scope of the present invention be defined by the claims appended hereto, giving full cognizance to equivalents in all respects. [0025] Surgical trocars are most commonly used in laparoscopic surgery. For example, prior to use of the trocar, the surgeon may introduce a Veress needle into the patient's abdominal cavity. The Veress needle has a stylet, which permits the introduction of gas into the abdominal cavity. After the Veress needle is properly inserted, it is connected to a gas source and the abdominal cavity is insufflated to an approximate abdominal pressure of, e.g., 15 mm Hg. By insufflating the abdominal cavity, pneumoperitoneum is created separating the wall of the body cavity from the internal organs. [0026] A trocar with a piercing tip is then used to puncture the body cavity. The piercing tip or obturator of the trocar is inserted through the cannula or sheath and the cannula partially enters the body cavity through the incision made by the trocar. The obturator may then be removed from the cannula and an elongated endoscope or camera may be inserted through the cannula to view the body cavity, or surgical instruments may be inserted to perform ligations or other procedures. [0027] A great deal of force is often required to cause the obturator to pierce the wall of the body cavity. When the piercing tip breaks through the cavity wall, resistance to penetration ceases and the tip may reach internal organs or blood vessels, with resultant lacerations and potentially serious injury. The creation of the pneumoperitoneum provides some free space within which the surgeon may stop the penetration of the trocar. To provide further protection, trocars have more recently been developed with spring loaded shields surrounding the piercing tip of the obturator. Once the piercing tip of the obturator has completely pierced the body cavity wall, the resistance of the tissue to the spring-loaded shield is reduced and the shield springs forward into the body cavity and covers the piercing tip. The shield thereby protects internal body organs and blood vessels from incidental contact with the piercing tip and resultant injury. [0028] Once the cannula has been introduced into the opening in the body cavity wall, the pneumoperitoneum may be maintained by introducing gas into the abdominal cavity through the cannula. Various seals and valves have been used to allow abdominal pressure to be maintained in this fashion. Maintaining abdominal pressure is important both to allow working room in the body cavity for instruments introduced through the cannula and to provide free space for the puncturing of the body cavity wall by one or more additional trocars as may be required for some procedures. [0029] A principal limitation of traditional laparoscopy relates to the fixed working envelope surrounding each trocar. These relatively small working envelopes often necessitate the placement of multiple ports in order to accommodate necessary changes in instrument position and to improve visibility and efficiency. The creation of additional ports is known to contribute to post-operative pain and to increase the risk of bleeding or organ damage. Therefore, the present invention has been developed to: (1) improve the control of tools within a surgical envelope; (2) reduce the number of trocars required (e.g., a single puncture); (3) improve the working envelope associated with, e.g., laproscopic surgery; and/or (4) improve instrument positioning, visibility and efficiency. [0030] The present invention has been evaluated in a dry laboratory as well as in porcine models, with several others currently under investigation. Some of the anchoring designs disclosed herein have been optimized for size, strength and surgical compatibility, as well as the benefits, limitations and prospects for the use of incision-less, magnetically-coupled tooling in laparoscopic surgery are now being performed with the use of trocars and cannulas. Originally these devices were used for making a puncture and leaving a tube to drain fluids. As technology and surgical techniques have advanced, it is now possible to insert surgical instruments through the cannulas and perform invasive procedures through openings less than half an inch in diameter. These surgical procedures required previously incisions of many inches. By minimizing the incision, the stress and loss of blood suffered by a patient is reduced and the patient's recovery time is dramatically reduced. [0031] The present invention is a platform capable of supporting one or more surgical tools that may are secured to the abdominal wall and subsequently positioned within the abdominal cavity through surgeon-controlled, e.g., using external magnetic couples on the patient's abdomen. Using the surgical anchor disclosed herein, in conjunction with the techniques outlined for magnetic manipulation, instruments such as miniature endoscopic cameras may be used to augment, e.g., the surgical field of view and surgical tools. The present inventors have evaluated the theoretical and empirical uses of anchoring designs optimized for size, strength and surgical compatibility, as well as the benefits, limitations and prospects for the use of incisionless, magnetically-coupled tooling in laparoscopic surgery. [0032] One such system is a magnetic anchoring system design. Several types and generations of magnetic anchoring schemes have been developed and evaluated. A fundamental design decision arises in generating the magnetic field electrically or via permanently magnetized materials. Electromagnets were initially favored due to: (1) the intrinsic ability to control the field strength, from zero to a maximum desired value; and (2) high magnetizing forces available in a relatively small footprint. Ex vivo and in vivo studies were used to evaluate the attractive force needed for use of electromagnets and permanent magnets. With electromagnets it was found that field strength was high at direct contact with the core, however, the field strength across tissue dropped-off drastically over relatively short distances, resulting in relatively bulky and heavy devices even after optimizing their length-to-diameter ratio and winding configuration. It was also found that heating caused by resistance limited the useful force attainable from an electromagnet due to its effect on skin contact temperature, winding insulation integrity, and surgeon comfort; these drawbacks may be overcome with active cooling. Given these constraints, permanent magnets were also investigated and they were found to deliver a higher coupling force per unit volume than the basic electromagnetic designs, and they can be controlled, when required, by adjusting their distance from their magnetic couple manually or in a closed-loop system. One limitation of permanent magnets relative to electromagnets is that the coupling force is always present, causing attraction to unintended targets and thus requiring strict handling procedures in the operating room. As such, in some applications electromagnets may be preferred, while in others permanent magnets may be preferred. [0033] Magnetic performance is the result of complex, three-dimensional field interactions governed by material, size, shape, location of magnetic poles, and location relative to the target. For this reason, practical design analyses and optimization are tractable only through computer simulation and empirical testing. In a transabdominal magnetic anchoring system design it was found that the coupling force between two magnets as a function of distance. A baseline analytic relationship is given by: F = B 2 ⁢ A 8 ⁢   ⁢ π ( 1 ) where F is the attractive force in dynes, B is the flux density in gauss, and A is the gap cross-sectional area in cm 2 . In the simplest case of interest, a pair of identical opposing cylindrical magnets of radius R, length L, and separated by an air gap G, the flux density at the gap center is approximated by: B = B r [ L + G 2 R 2 + ( L + G 2 ) 2 - G 2 R 2 + ( G 2 ) 2 ] ( 2 ) where Br, the residual flux density, is a material property. [0034] The resulting force vs. gap characteristic resembled an inverse power relationship. In arriving at an optimal magnetic anchoring system configuration, the main constraint is the size of the intraabdominal couple; e.g., it was designed to fit through a standard 12 or 15 mm trocar port in conjunction with its attached tooling. The dimensions of the external anchor are not critical but must be kept as small as practical and ergonomically compatible with abdominal laparoscopic surgery. Lastly, the device will produce generally an appropriate coupling force, nominally higher than 500 grams at a 10 mm gap to be useful. These parameters have led to two different magnetic anchoring system embodiments, based on a ø9×12 mm internal magnet coupled to a ø25×50 mm external magnet in single-stack and double stack (side-by-side, 25 mm between centerlines) configurations; all use NdFeB rare-earth magnets. [0035] The surgical anchor described herein may be used as a general purpose platform to which a variety of intraabdominal tools can be attached as well as externally positioned by the surgeon. One design constraint for these tools is that they must collapse to a cylindrical envelope 12 to 15 mm in diameter for insertion through the trocar; this is typically accomplished through pin joints which also allow for relative link motion when coupled to two external anchors. The tools that may be anchored to the surgical anchor may also be capable of self-actuation, e.g., self-actuating scissors, graspers, hook cautery, and fine-scan motion cameras. Unlike the recent generation of laparoscopic surgical robots, however, these instruments neither require, nor are limited, by the standard working envelope of a dedicated trocar port. [0036] FIG. 1A is an isometric view of one embodiment of the surgical anchor 10 of the present invention. The surgical anchor 10 depicted incorporates an opening 12 depicted having a conical shape within top surface 14 and having a conical focal point at the bottom of the opening 12 through which a pin (not depicted) is inserted to anchor the surgical anchor 10 to a surface. Also depicted are two pads 16 that, in this embodiment, are generally round and are inserted into the top surface 14 of the surgical anchor 10 . Pads 16 may be made from, e.g., a ferrous material, coated with teflon or even a magnetic material. In one example, the pads 16 may be a ferrous, ferromagnetic, a magnetic material or combinations thereof that provide for external magnetic positioning and control of the surgical anchor 10 within a body lumen, e.g., the peritoneal cavity after insertion through a trocar. In this view, at least one anchor point 18 is depicted for holding a surgical tool (not depicted). The anchoring mechanism of the anchor point 18 may be integral with the surgical anchor 10 , however, in this embodiment is depicted with a cotter pin 20 to which a wide variety of surgical tools may be attached. [0037] FIGS. 1B and 1C are cross-sectional view of surgical anchor 10 of the present invention in which two types of locking mechanisms for the pin 15 having a pin lock 17 . The pin 17 will generally have a sharpened point for traversing a tissue. To hold the pin 15 in place, a pin lock 17 , in this embodiment depicted as having a shaft 17 a and a lock pad 17 b is depicted. As with the surgical anchor 10 depicted in FIG. 1A , the surgical anchor of FIG. 1B includes as opening 12 having a conical focal point at the bottom of the opening 12 through which the pin 15 is inserted to anchor the surgical anchor 10 , and having a locking arm 19 that self-locks. The pin 15 depicted has serrations 21 , which may be used to increase friction and thereby improve the anchoring capacity of the surgical anchor 10 . FIG. 1C depicts another variation of a locking mechanism for the pin 15 and surgical anchor 12 in which the serrations 21 thread into an internal thread 23 . When using the surgical anchors 10 depicted in FIGS. 1B and 1C , the surgeon position the surgical anchor 10 as the anchor site and then may lock the anchor into position semi-permanently by inserting the pin 15 into the self-locking mechanism. [0038] In traditional forms of laparoscopic surgery, laparoscopic instruments inserted into a body cavity are manipulated principally by the application of force to the portion of the laparoscopic instrument protruding from the patient and integral with a handle. The handle is controlled by the surgeon and requires at all times insertion through a trocar, e.g., a 5, 8, 10, 12 or even a 15 mm ID (internal diameter) trocar. Although this method is useful for adjusting the depth of insertion of the laparoscopic instrument and can provide a limited range of angular or side-to-side movement, all but minor changes in the orientation of the laparoscopic instrument may be accomplished without the creation of additional incisions in the patient. [0039] The surgical anchor 10 of the present invention provides several distinct advantages over the use or conventional hand-held laproscopic tools. First, it provides an independent anchor point for the attachment of one or more surgical tools, retractors, scalpels, cameras, lights and the like that are inserted once into the patient through a single trocar. The independent surgical anchor 10 is anchored to the lumen of the body cavity by insertion of a single small pin, which may attached via, e.g., a self-locking mechanism, thereby providing a hands-free anchor point for other tools while also freeing-up the trocar for insertion of additional anchors of providing for insertion of another working surgical tool. Second, one or more independent surgical anchors may be inserted and tools may be swapped between the anchors without the need for additional large incisions. Third, by using magnetic positioning, the same surgical anchor may be moved from location to location, again reducing the number of major incisions while allowing maximum flexibility for tool use and positioning. [0040] FIG. 2A is a bottom view of the surgical tool 10 that depicts a single anchor-point opening 22 in relation to the pads 16 and the opening 12 . A self-locking ring 24 is depicted at the focal point of-the opening 12 . The self-locking ring 24 may easily be replaced with a screw (internal or external), a bolt or other fastener for a pin. In one embodiment, the entire structure of the surgical tool may be a plastic or ferrous material. [0041] FIG. 2B is a cross-section of the surgical tool 10 that depicts the relationship between the opening 12 , pad openings 16 , the anchor point 18 and the cotter pin 20 . In this cross-sectional view the surgical anchor 10 is depicted as top and a bottom components ( 26 , 28 ), however, the surgical anchor 10 may be of unitary construction using, e.g., molding, milling and the like. The opening 12 is depicted as having generally a conical shape, however, any number of shapes or combination of shapes may be used for the opening, e.g., a circular and/or conical shape having a 135 degree internal angle may be used for pin insertion. [0042] FIG. 2C is a top of the surgical anchor 10 that depicts two pad openings 26 in relation to the opening 12 on top surface 14 . As will be apparent from the current disclosure, additional openings 12 and pad openings 26 may be added and positioned in a linear, parallel, square, oval, round, and/or in two and three-dimensions. The surgical anchor 10 shown in FIG. 1 is positioned in place by manual manipulation, or may be positioned with the help of, e.g., a magnetic field. [0043] FIG. 3 shows the empirical versus simulated coupling force of a magnetic field. FIG. 3 shows the force (in grams) versus gap data. FIG. 4 is a magnetic field simulation of the magnetic flux paths for a single-stack magnet configuration. In certain embodiments, the magnets may be permanent magnets generating a magnetic field of a constant strength. In other embodiments, the magnetic field may be an electromagnetic field having a constant strength, a variable strength, or a varying time-dependent strength. Magnetic fields for use with the present invention may be single magnetic sources, or may be composed of arrays of smaller sources. In one embodiment, the pads 16 are magnetic pads that are attracted to a ferrous material external to the lumen, e.g., a single attachment point on a stand, a wire or even a three-dimensional cover that is positioned over the surgical subject or patient. In yet another embodiment, both the surgical anchor 12 and the external positioning and/or attachment point are magnetic. [0044] Surgical tools for use with the present invention will generally be sized to be passable through a trocar port by a laparoscopic grasper or forceps for attachment to the surgical anchor 10 . In some cases, it may be desirable for the surgical tools to be a camera, a camera with one or more lights (e.g., optic fibers), surgical retractors, e.g., a retractor, a sling retractor, a paddle retractor, a basket, a bag, a hook and the like, a cutting tool, e.g., a laser or a scalpel, or even a suction tube for removal of tissue. The surgical tool will include a hook or other locking mechanism that is complementary with the anchor point 18 . The surgical anchor 10 , the surgical tools, etc. may be formed of metal, plastic, combination of metal and plastics or other suitable material. The surgical tool may also include drawstrings to help remove the surgical tool through the trocar or other opening after use. [0045] In one specific example, the surgical tool that is anchored to the abdominal lumen may be a high-resolution charge-coupled device (CCD) camera or even an analog camera. While the camera may obtain and transmit a signal independent of an external power source, the surgical anchor of the present invention may also provide electrical and optical contacts with the surgical tool attached to the surgical anchor. For example, a camera and lights may obtain, e.g., electrical power from the pin and be grounded via the patient or a wire within the pin. If the pin is made of, or includes, optic fiber, a signal may be transmitted to and from the camera through the pin itself. The pin may even provide electrical, mechanical, pneumatic, communications and the like to the surgical tool via or around the surgical anchor. In another embodiment, the camera delivers a signal via a radio frequency or other transmission system and is wireless. [0046] The sensitivity, reliability and simplicity of operation of the system may be evaluated by direct comparison to conventional images captured using conventional laparoscopic instruments. Other image capture systems may be used in conjunction with the imaging system. For example, fiber optic leads may be placed close to the image and the image transferred for capture outside the body. In addition, wavelengths outside visible light may be captured by the imaging system. [0047] FIGS. 5A and 5B are a side and a bottom view of a trocar cable and light port 40 , respectively, that may be used in conjunction with the present invention. Typically, light is required for any video system to transmit a signal for use in surgery. The trocar cable and light port 40 permits for the insertion of additional wires, optical fiber and pneumatic lines into, e.g., the abdominal area to provide command, control and electrical connections through the abdominal wall without leaking gas out of the abdomen. The trocar cable and light port 40 has one or more internal conduits 42 that traverse the length of the trocar cable and light port 40 and through which one or more cables, optic fiber and pneumatic lines may be inserted into the patient, while at the same time maintaining access to the intraabdominal cavity through the trocar. When not in use, the conduits 42 may be plugged at one or both ends or may even include a gel or gel-like materials that seals the conduit and thereby the trocar. Furthermore, the trocar cable and light port 40 depicted also includes a gas release opening 44 for introduction or release of gas from the intraabdominal or other cavity. [0048] In conjunction with the surgical anchor 10 , one or more conventional laproscopic tools may be inserted, positioned and used at the same time after introduction into the abdominal cavity through a single abdominal incision. Unlike conventional trocars which have a single smooth opening, the trocar cable and light port 40 allows the insertion of cables and a conventional laproscopic tool at the same time. [0049] FIGS. 6A and 6B are a top and cross-sectional view, respectively, of a dual external magnet stack 50 for use with the surgical anchor when the surgical anchor is made of, or includes, a magnetically attracting material. The dual external magnet stack 50 has magnet openings 52 in casing 54 and will generally be small enough to be hand-held. Into each of the magnet opening 52 may be inserted a magnetic source in: N—S, S—N, S—S or N—N orientation. In one embodiment, the magnet is an electromagnet and the strength and orientation of the field may be externally controlled by providing power to the electromagnet. The magnet openings 52 are depicted as cylindrical, however, they may have any shape: oval, square, rectangular, etc. The holes 56 in the casing 54 and may be used to attach the dual external magnet stack 50 to a stand or holder. One particularly useful aspect of the dual external magnet stack 50 is that, when used in conjunction with the surgical anchor 10 depicted in FIG. 1 having pads 16 , the dual external magnet stack 50 may be used to turn the surgical anchor 360 degrees while anchored by magnetically coupling the each of the magnets of the dual stack each to one of the pads 16 . [0050] FIG. 6C combined the dual external magnet stack 50 has magnets 58 in the casing 54 in combination with the surgical anchor 10 depicted in FIG. 1A . The surgical anchor 20 is also shown in cross-section and with opening 12 through which the pin 15 is inserted to anchor the surgical anchor 10 , and having a locking arm 19 that self-locks. The pin 15 then traverses the magnet stack 50 , which includes within its casing 54 an opening 59 that has a internal opening into which the pin lock 17 is inserted and which may even permit the pin 15 to be locked into position with the magnet stack 50 . By using the combination of the magnetic stack 50 with the pin 15 and the surgical anchor 10 , the surgical anchor may even be rotated 360 degrees under the external control of the surgeon by rotating the magnet stack 50 , which is magnetically connected with the surgical anchor when the pads 16 are of a magnetically attracting material. [0051] A wide variety of permanent magnets may be used with the present invention, such as rare earth magnets, ceramic magnets, alnico magnets, which may be rigid, semi-rigid or flexible. Flexible magnets are made by impregnating a flexible material such as neoprene rubber, vinyl, nitrile, nylon or a plastic with a material such as iron having magnetic characteristics. Other examples of magnets for use as described hereinabove, are rare earth magnets include neodymium iron boron (NdFeB) and Samarium Cobalt (SmCo) classes of magnets. Within each of these classes are a number of different grades that have a wide range of properties and application requirements. Rare earth magnets are available in sintered as well as in bonded form. [0052] Ceramic magnets are sintered permanent magnets composed of Barium Ferrite (BaO (Fe 2 O 3 ) n ) or Strontium Ferrite (SnO(Fe 2 O 3 ) n ), where n is a variable quantity of ferrite. Also known as anisotropic hexaferrites, this class of magnets is useful due to its good resistance to demagnetization and its low cost. While ceramic magnets tend to be hard and brittle, requiring special machining techniques, these magnets can be used in magnetic holding devices having very precise specifications or may be positioned within a protective cover, e.g., a plastic cover. Anisotropic grades are oriented during manufacturing, and must be magnetized in a specified direction. Ceramic magnets may also be isotropic, and are often more convenient due to their lower cost. Ceramic magnets are useful in a wide range of applications and can be pre-capped or formed for use with the present invention. [0053] FIG. 7 is an isometric view of one embodiment of an anchored tool 60 . The anchored tool 60 has surgical anchors ( 62 a , 62 b ) that may be individually anchored and/or controlled. In the embodiment depicted, magnets ( 64 a, b, c and d ) are depicted in the surgical anchors 62 a , 62 b for control and positioning via, e.g., the dual external magnet stack 50 . In the anchored tool 60 , the surgical anchors 62 a , 62 b art connected via universal joints ( 64 a , 64 b ) to arms ( 66 a , 66 b ), respectively, which are in turn connected to each other at joint 68 . Connected to the joint 68 and under three dimensional control by the surgical anchors 62 a , 62 b via the arms 66 a , 66 b , is a tool 70 , in this case depicted as a paddle retractor. [0054] FIG. 8 is an isometric view of another embodiment of an anchored tool 80 that includes, in this example, an actuated paddle retractor 82 and further includes a piston 84 that may be connected to a pneumatic source (not depicted) through an opening 86 in the pin 15 . By providing pneumatic power from an external source through the opening 86 in pin 15 via a pneumatic connection 88 with the piston 84 to the paddle retractor 82 , the surgeon is able to apply variable amounts of pressure at the desired time to the tool 80 . The anchored tool 80 is depicted with two different embodiment of the surgical anchors 62 a , 62 b for control and positioning via the dual external magnet stack 50 . In this embodiment, the magnet stack 50 is depicted with locks 90 that lock into position the pins 50 and which, as depicted, may be used to raise and lower the pins 15 in relation to anchors 62 a , 62 b via fine adjustments. An example of a lock 90 may be a self-locking or even a threaded lock that holds the pin via mechanical friction. [0055] FIG. 9 is an isometric view of another embodiment of an anchored tool 100 that includes, in this example, a cutting hook 102 that is connected to an actuation arm 104 and further includes a piston 84 that may be connected to a pneumatic source via pneumatic connection 88 by pneumatic power provided through opening 86 in the pin 15 . Also depicted in FIG. 9 is an electrical actuator 106 that is electrically connected to an external power source via wires 108 that electrically connect via the surgical anchor 10 with external electrical power provided via pin 15 . By providing both electrical and pneumatic power from an external source through the pin 15 , the surgeon is able to apply variable amounts of pressure at the desired time to the tool 80 , provide for electrical and even computer control of the arm 104 and power to the hook cutting tool 102 . [0056] The embodiments and examples set forth herein are presented to best explain the present invention and its practical application and to thereby enable those skilled in the art to make and utilize the invention. Those skilled in the art, however, will recognize that the foregoing description and examples have been presented for the purpose of illustration and example only. Other variations and modifications of the present invention will be apparent to those of skill in the art, and it is the intent of the appended claims that such variations and modifications be covered. The description as set forth is not intended to be exhaustive or to limit the scope of the invention. Many modifications and variations are possible in light of the above teaching without departing from the spirit and scope of the following claims. It is contemplated that the use of the present invention can involve components having different characteristics. It is intended that the scope of the present invention be defined by the claims appended hereto, giving full cognizance to equivalents in all respects.

1a

FIELD OF THE INVENTION [0001] The present invention relates generally to hand-held instruments and tools. In preferred forms, the present invention relates to hand-held surgical instruments, especially those usefully employed for ophthalmic surgical procedures. BACKGROUND AND SUMMARY OF THE INVENTION [0002] Ophthalmic surgical procedures require the use of miniaturized instruments such as, for example, forceps, scissors and the like in order to allow the surgeon to operate on and within a patient's eye. One well known instrument that is used for such ophthalmic surgical procedures is the so-called Sutherland-type instrument commercially available from Alcon Grieshaber. The Sutherland-type instrument has a pen-like handle and uses a lever as an actuator for actuating mechanically operable spring-loaded tools, such as forceps, scissors, knives and the like which are threaded or otherwise operably connected to the distal end of the handle. [0003] Recently, improvements to such Sutherland-type instruments have been proposed in U.S. Pat. No. 5,634,918 (the entire content of which is expressly incorporated hereinto by reference). In general, the improvements proposed by the '918 Patent include providing a circumferentially arranged series of lever-like triggers which are pivotal in response to a radial force being applied thereto. Radially inward and outward pivotal movements of one trigger will, in turn, be converted respectively into rightward and leftward translation of the trigger retainer and is accompanied by like simultaneous movement of all the other triggers. Thus, any working tool attached operable to the trigger retainer will likewise translate rightward and leftward therewith. [0004] Additional improvements in Sutherland-type instruments are disclosed in copending U.S. patent application Ser. No. 09/549,469 filed on Apr. 14, 2000, the entire content of which is expressly incorporated hereinto by reference, in which a radially flexible actuator band is seated in a generally V-shaped circumferential channel defined between a pair of rings, at least one of which is longitudinally moveable. In response to a radially compressive force. The actuator band will therefore be flexed radially inwardly so as to longitudinally move at least one of the slide rings, and hence a distally mounted tool operatively connected thereto. [0005] The present invention is directed to further improvements in surgical instruments of the Sutherland-type. In this regard, the present invention broadly is directed to hand-held instruments which may be employed to actuate a distally mounted tool by application of radial force about the entirety of the instrument circumference (i.e., is omni-actuatable). In preferred forms, the present invention is embodied in hand-held instruments having a handle which includes an actuator assembly for actuating a tool, wherein the actuator assembly includes a plurality of circumferentially spaced-apart generally L-shaped actuator levers defining respective arcuate bearing surfaces along exterior edge regions thereof, and a retaining ring which circumferentially bounds the actuator levers around said exterior edge regions thereof. The retaining ring most preferably defines an interior stationary arcuate guide surface in conformable mated relationship to the bearing surfaces of said actuator levers. [0006] In especially preferred embodiments, the actuation levers are one-piece structures which include a proximally extending manually actuable arm section, and a generally radially downwardly extending leg section. Bearing surfaces are defined along exterior edge regions of the levers at respective junctures between these arm and leg sections so as to cooperate with the conformably shaped guide surface of the retaining ring. [0007] Most preferably the levers have proximally extending arm sections which are planar structural elements oriented coincidentally in respective radial planes emanating from the longitudinal axis of the device. These proximally extending arm sections thus define edge regions which establish generatrices of a curved surface (which may be convexly and/or concavely curved) in surrounding relationship to the device's longitudinal axis. [0008] These as well as other aspects and advantages of the present invention will become more clear after careful consideration is given to the following detailed description of the preferred exemplary embodiments thereof. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS [0009] Reference will hereinafter be made to the accompanying drawings, wherein like reference numerals throughout the various FIGURES denote like structural elements, and wherein [0010] [0010]FIG. 1 is a perspective view of a hand-held surgical instrument in accordance with a presently preferred embodiment of the invention; [0011] [0011]FIG. 2 is an enlarged perspective view of the actuator assembly employed in the surgical instrument of FIG. 1; [0012] [0012]FIGS. 3 and 4 each depict a cross-sectional elevational view of the actuator assembly of the present invention in rest and operative conditions thereof, respectively; and [0013] [0013]FIGS. 5A and 5B depict an alternative embodiments of the actuating levers that may be employed in the present invention. DETAILED DESCRIPTION OF THE INVENTION [0014] Accompanying FIG. 1 depicts an exemplary embodiment of a hand-held surgical instrument 10 according to the present invention. In this regard, the surgical instrument 10 includes an elongated handle 12 sized and configured to allow the instrument 10 to be handled manually by a surgeon during surgical procedures. The handle 12 includes a manually operated actuator assembly 10 - 1 which serves to actuate a tool 11 operatively attached to, and extending from, the distal end of the handle. The tool 11 , for example, may be a miniature forceps 11 - 1 positioned at the distal-most end thereof which open and close in response to actuation of the actuator assembly 10 - 1 in a manner that will be described in greater detail below. [0015] As is perhaps more clearly shown in accompanying FIG. 2, the distal end 12 - 1 of the handle 12 includes an axially elongate cylindrical recess 12 - 2 which receives a proximal correspondingly configured stem portion 14 - 1 of the actuation pin holder 14 . The stem portion 14 - 1 of the actuation pin holder 14 is most preferably fixed immovably within the recess 12 - 2 by any convenient technique, for example, by press-fitting and/or adhesives, so that the actuation pin holder 14 is a rigid distal extension of the handle 12 . [0016] The distal end of the actuation pin holder 14 is provided with a circumferentially enlarged male head portion 14 - 3 which is threadably coupled to a threaded female recess portion 16 - 1 of the lever housing 16 , the purpose and function of which will be described in greater detail below. [0017] The actuation pin holder 14 also defines a distally open-ended, axially oriented, cylindrical hollow 14 - 2 which is sized so as to movably receive therewithin the proximal barrel portion 18 - 1 of the actuation pin 18 . The barrel portion 18 - 1 is therefore capable of coaxially longitudinal sliding movements within the hollow 14 - 2 of the pin holder 14 so as to move axially between advanced and retracted conditions. In this regard, the structures are shown in accompanying FIG. 2 as being in their respective rest, or “normal” conditions. Thus, the “normal” condition for the actuation pin 18 is in its retracted condition as shown therein. [0018] The distal end of the actuation pin 18 includes a generally conically shaped bearing nib 18 - 2 which distally projects from an axially transverse flange 18 - 3 . An annular channel 18 - 4 is defined between the transverse flange 18 - 3 and the proximally disposed barrel portion 18 - 1 and receives the terminal end regions of each of the circumferentially spaced-apart actuation levers (a few of which are identified in FIG. 2 by reference numeral 20 ). [0019] As shown, each of the actuation levers 20 is generally L-shaped and includes a proximally extending arm section 20 - 1 of substantially greater length as compared to the distal leg section 20 - 2 . The levers 20 are most preferably one-piece structures and define an arcuately shaped bearing surface 20 - 3 along an outer edge region generally at the juncture of the arm and leg sections 20 - 1 , 20 - 2 . [0020] The housing 16 defines a plurality of radially oriented slots corresponding in number to the number of actuation levers 20 . The slots 16 - 2 are circumferentially spaced-apart from one another by an equal angular distance so that each receives therein a respective one of the actuation levers 20 generally at the juncture between the arm and leg sections 20 - 1 and 20 - 2 . The levers 20 are thus also circumferentially spaced apart from one another about the central longitudinal axis A l (see FIG. 2) of the device 10 and thus the actuation pin 18 also. In such a manner, the arm sections 20 - 1 of each lever 20 extend proximally outwardly from the housing 16 and thus bridge the space between the housing 16 and the distal tapered end 12 - 3 of the handle 12 in coaxially circumferentially surrounding relationship to the actuation pin holder 14 . These numerous exposed arm sections 20 - 1 of each actuation lever 20 thereby present the attending surgeon with a tactile sensation of a seemingly “solid” surface surrounding the central longitudinal axis of the device 10 . Thus, the exposed proximally extending outer edge regions of the arm sections 20 - 1 will establish the generatrices of a curved surface which coaxially surrounds the longitudinal axis A l of the device 10 and essentially bridges the distance between the distal lever housing 16 and the proximal handle 12 . [0021] The actuation levers 20 are physically retained in each of their respective slots by an annular retaining ring 22 which bounds the housing 16 and the individual actuation levers 20 disposed in the slots 16 - 2 . The retaining ring 22 defines an interior cross-sectionally arcuate stationary guide surface 22 - 1 which conformably mates with the bearing surface 20 - 3 of each of the actuation levers 20 . Thus, the radii of curvature of each of the surfaces 22 - 1 and 20 - 3 are coincident with one another. [0022] As will be observed particularly in FIGS. 1 and 2, the individual actuation levers 20 are most preferably relatively thin, planar structures which are oriented in the radial slots 16 - 2 of the housing 16 so as to be disposed coincident with radial planes from the central axis A l . The exposed outer proximal edge regions of each of the levers 20 may thus be provided with serrations 20 - 4 so as to promote a more rough feel to the attending surgeon. Other means may also be employed in order to improve the tactile sensation and/or feel of the levers 20 , such as, for example coating at least the external exposed edges of the levers with a friction material (e.g., an elastomeric material) or the like. [0023] The operation of the actuator assembly 10 - 1 employed in the hand-held surgical device 10 in accordance with the present invention is depicted generally in accompanying FIGS. 3 and 4. In this regard, the proximal end 11 - 2 of the tool 11 (see FIG. 1) may be threadably and removeably connected to the threaded nipple 16 - 3 coaxially extending distally from the housing 16 . Although not shown, the tool 11 will conventionally have an actuator rod which extends through the nipple 16 - 3 proximally into operative engagement with the bearing nib 18 - 2 . Moreover, the tool 11 is conventionally provided with a spring element which urges the actuation rod thereof into contact with the activation nib 18 - 2 . Thus, the force of the tool's spring element will cause the actuation pin 18 to be displaced proximally within the holder 14 so that it assumes its “normal” or rest condition as shown in FIG. 3. [0024] Upon application of a radially inwardly directed force (as noted by the arrows A f in FIG. 3), the lever arms 20 - 1 are caused to move collectively toward the holder 14 (that is, to be moved to a position closer to the central axis A l of the device 10 ). More specifically, the bearing surfaces 20 - 3 of the levers 20 are caused to slide along the cross-sectionally arcuate guide surface 22 - 1 of the retainer ring 22 so that as to cause the radially inwardly directed lever leg 20 - 2 to be moved generally pivotally from its rest condition as shown in FIG. 3 to its active condition as shown in FIG. 4. As will be observed, since the terminal ends of each of the legs 20 - 2 are received within the annular channel 18 - 4 of the actuation pin 18 , such movement (or “throw”) of the lever legs 20 - 2 will translate in coaxial linear movement of the actuator pin 18 (and hence its distally extending actuation nib 18 - 2 ) from its rest position as shown in FIG. 3 to its actuation condition in the direction of arrow Am as shown in FIG. 4. Thus, the nib 18 - 2 will push the tool's actuation rod (not shown) distally against the bias force of the tool's spring element (also not shown) to cause actuation of the working elements of the tool 11 , such as the miniature forceps 11 - 1 as depicted in FIG. 1. [0025] It should be noted here that, although the tool 11 is in and or itself conventional and of the type that may be employed generally in combination with Sutherland-type instruments—that is, will have its own self-contained spring element—the surgical devices 10 in accordance with this invention could alternatively (or additionally) be provided with a spring element. For example, a spring element could be positioned within the hollow 14 - 2 of the holder 14 and exert an appropriate bias force on the actuation pin 18 as may be required or desired. [0026] Accompanying FIG. 5A and 5B depict alternative embodiments of the actuator assembly 10 - 1 that may be employed in the devices of the present invention. In this regard, each of the actuator assemblies 10 - 1 ′ and 10 - 1 ″ shown in FIGS. 5A and 5B, respectively, is generally identical to the actuator assembly 10 - 1 , with the principal exceptions being the configurations of the levers 20 and the retaining ring 22 . Thus, identical structural elements among the various embodiments are noted by the same reference numerals. [0027] By way of example, the embodiment depicted in FIG. 5A includes actuation levers 20 ′ which define a generally semi-circular bearing surface 20 - 3 ′ provided generally at the juncture between the proximally extending lever arm sections 20 - 1 ″ and the downwardly radially projecting leg sections 20 - 2 ′ . This bearing surface 20 - 3 ′ therefore bears against, and cooperates with, a semi-circularly shaped guide surface 22 - 1 ′ defined in cross-section by the retaining ring 22 ′. A retaining lip 20 - 5 is also provided as an extension of sorts of the bearing surface 20 - 3 ′ and therefore projects somewhat distally around the guide surface 22 - 1 ′ so as to assist in the sliding movement of the bearing surface 20 - 3 ′ against the stationary guide surface 22 - 1 ′. [0028] The terminal ends of the lever leg sections 20 - 2 ′ terminate in a slightly arcuate terminal edge 20 - 4 ′ which is received within the recessed channel 18 - 4 of the actuation pin 18 . The center of the arcuate terminal edge 20 - 4 ′ is coincident with centers of the semi-circular bearing surface 20 - 3 ′ and guide surface 22 - 1 ′, capturing the levers 20 ′ between them. The arcuate edges 20 - 4 ′ of the leg sections 20 - 2 ′ thereby help to ensure relatively smooth pivoting of the levers 20 - 1 ′ around the coincident centers of the arcs defined by the surfaces 20 - 3 ′, 22 - 1 ′ and 20 - 4 ′ and thus relatively smooth movements of the actuation pin 18 . The coincident centers of the arcs defined by surfaces 20 - 3 ′, 22 - 1 ′ and 20 - 4 ′ may lie outside the major diameter of the handle. [0029] It will also be observed that the leg sections 20 - 2 ′ project downwardly and somewhat proximally as compared to the leg sections 20 - 2 discussed previously. Thus, instead of the arm and leg sections 20 - 1 and 20 - 2 , respectively forming a substantially right (or minimally obtuse) angle therebetween, the arm and leg sections 20 - 1 ′ and 20 ′- 2 ′ form a somewhat acute angle therebetween. [0030] The levers 20 ″ shown in FIG. 5B are substantially identical to the levers 20 ′ shown in FIG. 5A except for the curvature of the arm sections 20 - 1 ″ thereof. In this regard, it will be observed that, whereas the proximally extending arm sections 20 - 1 ′ of the levers 20 ′ shown in FIG. 5A have a slight convex curvature, the arm sections 20 - 1 ″ have a slight concave curvature. Of course, the levers that may be employed in the practice of this invention may have virtually any geometric configuration and/or curvature combination (including levers having respective sections of convex and concave curvatures) as may be desired by an individual physician's personal preference. Thus, for example, instead of having any curvature (concave and/or convex), the levers may define a linear edge which is substantially parallel or even somewhat angularly disposed relative to the longitudinal axis A l . [0031] While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuaton of International Application PCT/EP01/12663 with an international filing date of Oct. 31, 2001, not published in the English language under PCT Article 21(2), and now abandoned. BACKGROUND OF INVENTION [0002] This invention relates to the use of procollagen (III) propeptides and related substances for treating fibrotic diseases and a method for producing and renaturing recombinant N- and/or C-terminal procollagen (III) propeptides. Said procollagen (III) propeptides and related substances are suitable for treating fibrosis of any type, of any organ manifestation. The invention also relates to a method for producing renatured N-terminal procollagen (III) propeptide and/or C-terminal procollagen (III) propeptide. [0003] Collagen Biosynthesis. [0004] The collagens of types I and III are synthesized as prepropeptides and are extensively modified posttranslationally. Among the intracellular modifications are glycosylations, enzymatic hydroxylation reactions involving lysine and proline in its 3- and 4-positions. The modified propeptides spontaneously assemble into [α 1 (III)]3 homotrimers in the case of collagen (III). In the case of collagen type I mostly [α 1(I)]2 α 2(I) heterotrimers as well as—to a lesser extent—[α 1(I)]3 homotrimers are formed. After exocytosis, the propeptides are first cleaved at the C-terminus of the nascent collagen and then at the N-terminus by a set of specific endoproteases. The cleavage resulting in the C-terminal procollagen propeptide (PIIICP) is catalyzed by the procollagen C-proteinase which is identical to the Bone Morphogenetic Protein-1. Different tissue-specific expression patterns of different splice variants of the BMP-1 protein have been discovered. [0005] The N-terminal procollagen propeptide of collagen I (PINP) is cleaved off by the same N-proteinase that also digests the N-terminal procollagen propeptide of collagen type II. By contrast, N-terminal procollagen (III) propeptide (PIIINP) is cleaved by off by a proteinase activity distinct from the N-proteinase (I and II). The responsible enzyme is called procollagen N-proteinase type III. [0006] PIIICP. [0007] PIIICP occurs as a trimer consisting of three identical monomeric PIIICP subunits that are linked by intermolecular disulfide bridges. Theoretical structural considerations and site-directed mutagenesis experiments with so-called collagen mini genes have led to the conclusion that at least 4 and probably 6 cysteine residues of each monomeric PIIICP subunit are involved in intramolecular disulfide bridge formation. It is likely that only the cysteine residues in positions 51 and 68 are involved in intermolecular disulfide bridge formation. It has been observed, however, that the region around these cysteine residues is critical for the correct formation of intramolecular disulfide bridges because a Cys→Ser mutation in that region leads to impaired intramolecular disulfide bridge formation. On the other hand it has been observed that the trimerization of collagen (III) fibrils proceeds even when interchain cystine bridge formation has become impossible by a Cys→Ser mutation in position 51. [0008] So far, there have been no reports about the quantification of PIIICP except in the patents: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1). [0009] There are no reports about pharmacokinetic data for PIIICP. For PICP, clearance and mode of elimination have been investigated. For 125 I-labeled PICP, an elimination from the serum by the mannose-6-phosphate receptor has been reported. PIIICP could also be cleared from the circulation by this receptor as PIIICP may also be glycosylated at position Asn173. This mechanism can safely be excluded for recombinant PIIICP from E. coli , however, as the protein is not glycosylated when expressed in this host. [0010] With regard to the physiological role of PIIICP, there is no information available in the literature. With regard to the biological effects of the C-terminal propeptide of collagen type I, different effects have been described in the literature. [0011] The nucleotide sequence of human PIIICP has been deposited in the Genebank (Accession No. X14420 and X01742). The amino acid sequence of this peptide is shown in FIG. 1 (I) as an example. The propeptide sequence is indicated in the appendix in the context of the whole procollagen sequence C-terminal of the procollagen C proteinase cleavage site. [0012] In fibroblast cell culture, a reduction of collagen production by 80% was measured when intact PICP was present at a concentration of 40 nM, while it was decreased by 30% at 10 nM. However, these changes in the protein biosynthesis very well correlated with the measured changes at the level of transcription. This lead to the speculation that PICP exerts a regulatory effect at the level of transcription. [0013] For intact rat PICP, isolated from fibroblasts, an inhibiton of collagen biosynthesis was also demonstrated with cell cultures of hepatic stellate cells. At a concentration of 33.3 nM an inhibitory effect of 66% was measured that increased to 83% at a concentration of 133.2 nM, respectively, Changes in mRNA concentrations affected by PICP were not investigated. It was shown in this series of experiments, however, that the inhibitory effect was strongly dependent on the structure of the protein. A covalent modification of PICP induced by the exposure to acetaldehyde lead to a marked reduction of the effect on collagen biosynthesis. [0014] The effects of overlapping synthetic polypeptides derived from the PICP sequence in a fibroblast cell culture model are reported ambiguously in the literature. [0015] An inhibitory effect at the level of the rate of biosynthesis was observed with a polypeptide consisting of 22 amino acid residues (residues 225 to 246). [0016] By contrast, a further polypeptide consisting of 45 amino acid residues (residues 197 to 242) lead to an increased rate of biosynthesis for collagens of types I and III as well as for fibronectin contrary to all previous results. At a concentration of 45 μM an increase of collagen biosynthesis by a factor of 3.3 and of fibronectin biosynthesis by a factor of 6.1 was observed in human lung fibroblasts after 4 h. After 8 a maximal stimulation of collagen biosynthesis by a factor of 6- to 8-fold was measured. [0017] However, the stimulatory effect was dependent on the degree of confluence of the cells. While an effect was observed in subconfluent fibroblast cells, this effect could not be demonstrated in confluent cells. The effects were neither cell type-nor species-specific. In further experiments the polypeptide sequence sufficient for eliciting the stimulatory effect could be reduced to a pentapeptide (amino acid residues 212 to 216). In these experiments, 80% of the maximal stimulation was observed. The effect was notably more pronounced with fibronectin (5- to 11-fold increase) in comparison with collagen type I (4- to 7-fold increase). In parallel to the experiments focused on the protein level, the mRNA concentrations of the concerned genes were investigated. For collagen as well as for fibronectin, no concentration changes were measured at the mRNA level. According to these data, the synthetic polypeptides exerted their effects on the stimulation of collagen biosynthesis at the posttranscriptional level. [0018] In vivo experiments with PIIICP or related substances have not been reported in the literature so far. [0019] PIIINP. [0020] PIIINP occurs as a trimer consisting of three identical monomeric PIIINP subunits that are linked by intermolecular disulfide bridges. The PIIINP molecule is structurally divided into three domains. The most N-terminally located domain (Col 1) consists of a globular structure and contains several intramolecular cystine bridges. The C-terminally adjacent Col3 domain possesses a collagen-like structure characterized by periodic Gly and Pro residues. This domain assembles into a characteristic triple-helical collagen-like structure. The Col2 domain encompasses those parts of the procollagen telopeptide region which are N-terminal of the N-proteinase cleavage site. The monomeric PIIINP strands are assembled parallel to each other in this region. [0021] Characteristically, the Col2 domain contains two cysteine residues that are both involved in intermolecular disulfide bridge formation and that are of eminent importance for the trimeric structure of PIIINP. An oligosaccharide glycosylation site is located in the vicinity of the N-proteinase (III) cleavage site. Eight amino acid residues C-terminal of the propeptide cleavage site, one of the four lysyl residues is located which are oxidatively desaminated into aldehydes before the collagen fibrils become covalently crosslinked. [0022] A special characteristic of collagen type III is that a fraction of the N-terminal propeptides is not cleaved off the procollagen trimer. This so-called pN-collagen type III is still incorporated into fibrils. The form of these fibrils is described in the literature in different ways: as thin fibrils which are associated with collagen type I or as pearl necklace-like fibrils that associate to become net-like structures. Electron-microscopically, pN-collagen of type III has the appearance of a “barbed wire”. The presence of pN-collagen type III on the surface of collagen fibrils could play a role in the regulation of the diameter of the fibrils. [0023] With regard to the stability of PIIINP in the body, half lives between 2 min and 239 min have been reported. The determined values varied considerably depending on the model and/or the labelling of the antigen. In rats a clearance of the N-terminal propeptide of collagens III and I from the serum independently of the antigen species by the scavenger receptor on liver endothelial cells has been reported (Melkko 1994). Endocytosis was mediated by the same receptor for both proteins. [0024] The amino acid sequence of human PIIINP is deposited in the Genebank database with the accession number X14420. As an example, the the amino acid sequences of this propeptide are shown in FIG. 1 (II). The propeptide sequence is indicated in the context of the whole procollagen sequence N-terminal of the procollagen N proteinase type III cleavage site. [0025] PIIINP has so far mostly been described as a marker of fibrosis. It can be used in the context of possible therapies of liver fibrosis as a possible non-invasive parameter to follow the course of the disease. [0026] For PIIINP, research about its role as a feedback inhibitor of collagen biosynthesis in cell culture systems and in cell-free lysates has been published. For the N-terminal propeptides of collagens type I and type III as well as for the Col 1 domain of PINP, a concentration-dependent cell-specific inhibition of collagen production of the α 1 (I) and α 2 (I) chains has been measured in the fibroblast cell culture system. Protein concentrations from 0.5 μM to 6 μM were used. The inhibition was in the range between 30% to 50% in comparison with control experiments. In these experiments experimental evidence was provided that the rate of translation was influenced by the propeptides and by their fragments. These data were supported by the localization of the internalized proteins in the vicinity of the endoplasmatic reticulum. [0027] In addition, experiments with the Col 1 domains of both N-terminal propeptides were carried out in the cell-free reticulocyte system. Protein concentrations ranging from 0.4 to 3.2 μM were used. A concentration-dependent inhibition of collagen (I) synthesis was measured. In both cases, an inhibition between 38% and 71% in comparison with control experiments was measured. When very high protein concentrations (8 μM) were used, it was demonstrated that the inhibitory effect on collagen translation could not be further increased. [0028] When the mechanism of action of PINP was investigated a system for the recombinant cyotosolic expression of PINP in fibroblast cell culture was also examined. While the measured collagen (I) mRNA concentration was unchanged, the rate of biosynthesis of the corresponding protein was reduced. It was therefore regulated at the post transcriptional level. [0029] These results for PINP are supported by experiments with skin fibroblasts from dermatosparactic sheep. In the homologous human disease, Ehlers Danlos syndrome of type VIIa or VIIb, a mutation within the N-proteinase cleavage site of procollagen type I occurs. Consequently, PINP cannot be cleaved off. In cell culture, these cells which lack the PINP feedback mechanism in comparison with heterozygous control fibroblasts, displayed a proportion of 15 to 20% of collagen biosynthesis compared to the total cellular biosynthesis (control fibroblasts 2 to 4%). [0030] Recombinant Production of Procollagen III Propeptides. [0031] The recombinant production of procollagen (III) propeptides has been reported in a number of publications. The recombinant production of a collagen α 2 (I) mutant in so-called A2 cells derived from the rat liver epithelial cell line W8 which is in turn deficient for collagen α 2 (I) is described. The recombinant expression of collagen α 1 (III) minigenes has been described more recently. [0032] Recently, the production of PIIICP in Zf9 cells as a trimeric protein has been described. The recombinant protein could only be produced in small quantities for analytical purposes, however. The recombinant production of PIIICP in E. coli was described in the patent applications: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1) and in Burchardt, 1998. The yields were above 20 mg/l fluid culture medium with this expression method. The majority of the recombinant protein was in the form of inclusion body protein, however, and had to be purified using denaturing methods of dissolution. The expressed proteins also contained an N-terminal His tag, so that they could be purified in denaturing solvents over a Ni-NTA column. For chronic in vivo applications, these proteins were less suitable because of the potential immunogenicity of the His tag and because the biological half-life of the recombinant proteins may be decreased for this reason. They occurred mostly in a monomeric form when the methods disclosed in this application were used. Their solubility was too low for most therapeutic applications. When a concentration of approximately 10 μg/ml was exceeded, the recombinant PIIICP precipitated from aqueous solutions. [0033] The recombinant expression of human PIIINP in E. coli has been described in the patent application: Monoclonal antibody and assay for detecting PIIINP (WO 99/61477A2), and the expression of murine PIIINP has been reported in Kauschke, 1999. The yields were at approximately 5 mg/l fluid culture medium with this expression method. These expressed proteins also contained an N-terminal His tag, so that they could be purified in denaturing solvents over a Ni-NTA column. For chronic in vivo applications, these proteins were also less suitable because of the potential immunogenicity of the His tag and because the biological half-life of the recombinant proteins may be decreased for this reason. The solubility of PIIINP in aqueous solutions was too low for most therapeutic applications. [0034] Fibrotic Diseases. [0035] Fibrotic diseases are defined as a diverse group of diseases that are associated with a qualitatively altered collagen production or with an increased deposition of collagen in the exrtracellular space. To this group of diseases belong, among others, systemic or localized scleroderma, liver fibrosis of various etiologies, alcoholic cirrhosis, e.g. alcoholic liver cirrhosis, biliary cirrhosis, hepatitis of viral or other origin, veno-occlusive disease, idiopathic interstitial fibrosis, idiopathic pulmonary fibrosis, interstitial pulmonary fibrosis, acute pulmonary fibrosis, acute respiratory distress syndrome, perimuscular fibrosis, pericentral fibrosis, dermatofibroma, kidney fibrosis, diabetic nephropathy, glomerulonephritis, keloids, hypertrophic scars, joint adhesions, arthrosis, myelofibrosis, corneal scaring, cystic fibrosis, muscular fibrosis, Duchenne's muscular dystrophy, esophageal stricture, retroabdominal scaring, Crohn's disease, ulcerative colitis, atherosclerotic alterations, pulmonary hypertension, angiopathy of the arteries and veins, aneurysms of large vessels. [0036] Further fibrotic diseases are induced or initiated by scar revisions, plastic surgeries, glaucoma, cataract fibrosis, corneal scaring, graft vs. host disease, tendon surgery, nerve entrapment, Dupuytren's contracture, OB/GYN adhesions, pelvic adhesions, infertility, peridural fibrosis, diseases of the thyroid gland or the parathyroids, metastatic bone disease, multiple myeloma, or restenoses. In many of the aforementioned diseases, a successful therapy has not been established so far. In others, a need for improved approaches or for the reduction of undesired side effects exists. [0037] From the aforementioned it follows that there is a further need to supply efficacious drugs against fibrotic diseases. The solution to this task is achieved by the embodiments presented in the examples. SUMMARY OF INVENTION [0038] Thus the present invention relates to a composition; preferably a medicament, containing (a) a (poly) peptide which is the N-terminal procollagen (III) propeptide and/or the C-terminal procollagen (III) propeptide or (b) a fragment or derivative thereof with mainly the antifibrotic activity of the (poly) peptide (a) and/or (c) a peptide which contains the recognition sequence of procollagen C-proteinase of type III and/or a peptide that contains the cleavage sequence of procollagen N-proteinase of type III, in combination with a pharmaceutically tolerable carrier or diluent. [0039] The term “(poly)peptide which is the N-terminal procollagen (III) propeptide and/or the C-terminal procollagen (III) propeptide” means in the light of the invention that the (poly) peptide is the N-terminal or C-terminal procollagen (III) propeptide to which further amino acid sequences can be added N-terminally or C-terminally so that a longer (poly) peptide is generated. The additional sequences can be derived from procollagen or can be heterologous or artificial sequences. Preferred are (poly) peptides which contain possible procollagen C- or N-proteinase-recognized cleavage sites in addition to the (human) PIIICP or PIIINP amino acid sequence. [0040] The term “a fragment or derivative thereof with mainly the antifibrotic activity of the (poly) peptide (a)” means in the light of the invention that this fragment or derivative thereof has at least 50%, preferably 75%, more preferred 85%, and especially preferred 90% of the antifibrotic activity of the N-terminal or C-terminal procollagen propeptide. Derivatives of the (poly) peptide may contain other amino acids than the natural amino acids or substituted amino acids. For example, derivatives can be obtained from peptidomimetics. [0041] While the following embodiments are commonly discussed in the context of medicaments, they also apply mutatis mutandis to the compositions. [0042] The term “(poly) peptide” applies to polypeptides as well as to peptides. A peptide commonly contains not more than 30 amino acids. [0043] Possible procollagen C-proteinase recognition sequences are indicated in FIG. 1 (I). [0044] Possible procollagen-N-proteinase recognition sequences are indicated in the PIIINP sequence in FIG. 1 (II). [0045] Examples of suitable pharmaceutically tolerable carriers and/or dilutants are known to the specialist and encompass for example phosphate-buffered saline solutions, water, emulsions, as for example oil/water emulsions, different kinds of detergents, sterile solutions, etc. Medicaments that contain such carriers can be formulated by known conventional methods. These medicaments can be administered to the individual at a suitable dose. The administration route can be oral or parenteral, for example intravenous, intraperitoneal, subcutaneous, intramuscular, local, intranasal, intrabronchial, oral or intradermal, or via a catheter at a location inside of an artery. Formulations for a parenteral administration encompass sterile aqueous or non-aqueous solutions, suspensions and emulsions. Examples of non-aqueous dilutants suitable for injections are propylene glycol, polyethylene glycol, plant oils, as for example olive oil, and organic esters, as for example ethyloleate. Aqueous carriers encompass water, alcoholic aqueous solutions, emulsions, suspensions, salt solutions and buffered media. Parenteral carriers encompass sodium chloride solutions, Ringer Dextrose, Dextrose and sodium chloride, Ringer Lactate, and bound oils. Intravenous carriers encompass, for example, fluid-, nutrient- and electrolyte-additives (as for example those that are based on Ringer Dextrose). The medicament can also contain preservatives and other additives, as for example antimicrobial compounds, antioxidants, complex forming substances and inert gases. Furthermore, it may contain other active agents, for example interleukins, growth factors, differentiation factors, interferons, chemotactic proteins, or an unspecific immunomodulatory agent. [0046] The kind of dosing is determined by the treating physician according to clinical factors. It is known to the specialist that the kind of dosing is dependent on different factors, e.g. body height or weight, respectively, the body surface, age, sex, or the general state of health of the patient, but also on the agent to be administered specifically, the duration and kind of administration, and on other medicaments that are possibly administered in parallel. A typical dose can for example be in the range between 0.001 and 1000 μg, whereby doses above and below this exemplary range are imaginable, in particular taking into account the factors mentioned above. Commonly, the dose should be in the range between 1 μg and 10 mg per day when the formulation of the invention is administered regularly. Commonly, the agents will be present at a concentration of more than 10 p g/ml in a physiological buffer in these formulations. They can, however also be present in a solid state at a concentration of 0.1 to 99.5% (weight/weight) in the final mixture. Commonly, it has proved to be of advantage to apply the agent(s) in total amounts of approximately 0.001 mg/kg to 100 mg/kg, preferably in total amounts of 0.01 mg/kg to 10 mg/kg body weight per 24 hours, as a continuous infusion or as several single administrations, to achieve the desired results. When the formulation is applied intravenously the dose should be in the range between 1 μg and 10 mg units per kilogram body weight per day. The medicament can be applied locally or systemically. [0047] Surprisingly, it was discovered in the present invention that the above mentioned (poly) peptides, and PIIICP in particular, are taken above in the liver in vivo and display antifibrotic activity. The mechanism of action of recombinant PIIICP by downregulation of connective tissue growth factor mRNA was surprising as well and unexpected. The role of PIIICP as a natural feedback inhibitor of fibrotic matrix deposition was described for the first time here. The findings of the invention were furthermore surprising because PIIICP/PIIINP were so far, for the most part, only discussed as diagnosis markers to monitor the effectiveness of other medicaments, but not in the context as a therapeutic agent for use in humans. The achieved antifibrotic effect was thus entirely surprising. [0048] In vivo experiments to ameliorate fibrotic diseases by administration of recombinant PIIINP have not been described in the literature so far. Because of the lacking glycosylation of recombinant PIIINP from E. coli the reduction of the fibrotic area described in this application was utterly surprising and unexpected. [0049] In a preferred embodiment the (poly) peptide or fragment or derivative and/or peptide stems from human procollagen (III) or is derived from it. [0050] In a further preferred embodiment the recognition sequence-containing (poly) peptide contains 10 to 15 amino acids N-terminal of the cleavage site. [0051] In an additional preferred embodiment the recognition sequence-containing (poly) peptide contains 10 to 15 amino acids C-terminal of the cleavage site. [0052] In a further preferred embodiment the (poly)peptide is a fusion protein. [0053] In an especially preferred embodiment the (poly)peptide contains a His tag. The His tag can be added C-terminally or N-terminally. [0054] In a further especially preferred embodiment the His tag is a 6 His tag and is added N-terminally. [0055] Furthermore, the present inventions relates to the use of the afore described (poly) peptide or fragment or derivative thereof to manufacture a medicament or medical device to treat or prevent fibrotic diseases. [0056] In a preferred embodiment the fibrotic diseases are chosen from systemic or localized scleroderma, liver fibrosis of various etiologies, alcoholic cirrhosis, e.g. alcoholic liver cirrhosis, biliary cirrhosis, hepatitis of viral or other origin, veno-occlusive disease, idiopathic interstitial fibrosis, idiopathic pulmonary fibrosis, interstitial pulmonary fibrosis, acute pulmonary fibrosis, acute respiratory distress syndrome, perimuscular fibrosis, pericentral fibrosis, dermatofibroma, kidney fibrosis, diabetic nephropathy, glomerulonephritis, keloids, hypertrophic scars, joint adhesions, arthrosis, myelofibrosis, corneal scaring, cystic fibrosis, muscular fibrosis, Duchenne's muscular dystrophy, esophageal stricture, retroabdominal scaring, Crohn's disease, ulcerative colitis, atherosclerotic alterations, pulmonary hypertension, angiopathy of the arteries and veins, aneurysms of large vessels or are induced or initiated by scar revisions, plastic surgeries, glaucoma, cataract fibrosis, corneal scaring, graft vs. host disease, tendon surgery, nerve entrapment, Dupuytren's contracture, OB/GYN adhesions, pelvic adhesions, infertility, peridural fibrosis, diseases of the thyroid gland or the parathyroids, metastatic bone disease, multiple myeloma, or restenoses. [0057] Furthermore, the present invention relates to a method to produce renatured N-terminal procollagen (III) propeptide and/or C-terminal procollagen (III) propeptide, where (a) inclusion bodies are produced in E. coli employing to commonly known methods, where the inclusion bodies are dissolved in a 0.5 to 8 M denaturing buffer; (b) the buffer according to (a) is pipetted dropwise into a limited dilution buffer that is buffered around neutral pH and contains L-Arginine in a final concentration between 200 to 1,000 nM and a disulifide bridges-reducing coupled redox system, until a volume ratio of the denaturing buffer to the limited dilution buffer of maximally 1:3 is reached, respectively; (c) the buffer mixture according to (b) is dialyzed against a physiological buffer that contains L-Arginine at a final concentration of 50 to 200 nM and a disulfide bridges-reducing coupled redox system for at least 2 hours; (d) the buffer mixture according to (c) is dialyzed against a physiological buffer that contains a disulifide bridges-reducing coupled redox system for at least 2 hours; and (e) the buffer mixture according to (d) is dialyzed against a physiological buffer for at least 2 hours. [0058] It follows that the buffer of step (d) contains no Arginine and in step (e) neither Arginine nor the redox system. [0059] The possibility to dissolve recombinant PIIICP in higher concentrations than previously described in physiological buffer was completely surprising and unexpected because it is known to the specialist that collagens are hard to dissolve in physiological buffers. [0060] By this method the therapeutic application of recombinant procollagen propeptides and of related substances in therapeutically relevant concentrations becomes possible. In example 4 the use of procollagen propeptides that were renatured according to this method in animal models of liver fibrosis is described. [0061] In a preferred embodiment a chelator is added to the buffer in at least one of the steps (b) to (d). Preferably the chelator is EDTA, for example at a final concentration of 10 mM. [0062] In a further preferred embodiment the redox system consists of reduced Glutathione oxidized Glutathione. It is especially preferred that the components of the redox system of example 2 occur at the concentrations disclosed in example 2. [0063] In another preferred embodiment a protease inhibitor is added to the buffer in at least one of the steps (b) to (d). Preferred is the protease inhibitor Pefabloc SC. [0064] In an additional preferred embodiment a salt is added to the buffer in one of the steps (b) and/or (d) at a final concentration of approximately 10 mM. Preferably, the salt is NaCl. It is especially preferred that the limited dilution buffer and the dialysis buffer are of the concentrations disclosed in example 2. [0065] In a further preferred embodiment the denaturing buffer of step (a) contains urea at a final concentration from 0.5 to 8 M. Preferentially, the buffer contains urea at a final concentration of approximately 6 M. [0066] In another preferred embodiment Trizma-Base is used as a buffer. [0067] In an additional preferred embodiment the dialysis steps are carried out at approximately 4° C. [0068] In another preferred embodiment the dialysis is carried out against at least 100 times the volume of the dialysate in steps (c) to (e). [0069] In addition, the present invention relates to a method to produce a medicament wherein the renatured N-terminal procollagen (III) propeptide and/or C-terminal procollagen (III) propeptide, which is produced according to claims 10 to 18, is concentrated according to common methods or lyophilised, and a pharmaceutically tolerable carrier or pharmaceutically tolerable diluent is added. [0070] Suitable, pharmaceutically tolerable carriers and dilutants have been discussed previously. [0071] Furthermore, the present invention relates to the use of an N-terminal procollagen (III) propeptide and/or C-terminal procollagen (III) propeptide which is produced according to the methods disclosed in the invention, to treat or prevent fibrotic diseases. [0072] In a preferred embodiment fibrotic diseases are chosen among systemic or localized scleroderma, liver fibrosis of various etiologies, alcoholic cirrhosis, e.g. alcoholic liver cirrhosis, biliary cirrhosis, hepatitis of viral or other origin, veno-occlusive disease, idiopathic interstitial fibrosis, idiopathic pulmonary fibrosis, interstitial pulmonary fibrosis, acute pulmonary fibrosis, acute respiratory distress syndrome, perimuscular fibrosis, pericentral fibrosis, dermatofibroma, kidney fibrosis, diabetic nephropathy, glomerulonephritis, keloids, hypertrophic scars, joint adhesions, arthrosis, myelofibrosis, corneal scaring, cystic fibrosis, muscular fibrosis, Duchenne's muscular dystrophy, esophageal stricture, retroabdominal scaring, Crohn's disease, ulcerative colitis, atherosclerotic alterations, pulmonary hypertension, angiopathy of the arteries and veins, aneurysms of large vessels or are induced or initiated by scar revisions, plastic surgeries, glaucoma, cataract fibrosis, corneal scaring, graft vs. host disease, tendon surgery, nerve entrapment, Dupuytren's contracture, OB/GYN adhesions, pelvic adhesions, infertility, peridural fibrosis, diseases of the thyroid gland or the parathyroids, metastatic bone disease, multiple myeloma, or restenoses. [0073] The tables show the following. [0074] Table 1 shows the body weight at the end of the experiment, the relative liver weight, GIDH serum activities, collagen types III and I as well as TGF-β 1 mRNA concentrations after chronic application of different procollagen α 1(III) propeptides in the mouse CCl4 model. mRNA concentrations after TaqMan analysis are presented as Δ ct values in comparison with the intact control (mean+/−SEM). [0075] Table 2 shows the body weight at the end of the experiment, the relative liver weight, GIDH serum activities collagen types III and I as well as TGF-β 1 mRNA concentrations after chronic application of different concentrations of the PIIICP4.1 protein in the mouse CCl4 model. MRNA concentrations after TaqMan analysis are presented as Δ ct values in comparison with the intact control (mean+/−SEM). [0076] [t1] TABLE 1 [t1] PIIICP4.1 PIIICP M1 (500 4.5.2. (500 (500 Fibrosis Intact Group μg/ml) μg/ml) μg/ml) Control Control Final 26.25 +/− 24.29 +/− 25.56 +/− 26.22 +/− 30.25 +/− Body 0.75 0.81 0.38 0.32 0.63 Weight (g) (p < 0.03) Liver 6.52 +/− 6.44 +/− 6.42 +/− 6.12 +/− 5.13 +/− Weight 0.13 0.16 0.12 0.12 0.26 (g/100 g body weight) GIDH 3715 +/− 3983 +/− 3977 +/− 4480 +/− 12 +/− Activity 268 305 312 269 4 (U/ml serum) Collagen 3.32. +/− 2.53 +/− 3.05 +/− 2.76 +/− 0.00 +/− α 1 (III) 0.32 0.37 0.28 0.29 0.24 mRNA- Conc. Collagen 4.62 +/− 4.27 +/− 5.13 +/− 4.63 +/− 0.00 +/− α 1 (I) mRNA- 0.35 0.18 0.33 0.33 0.12 Conc. TGF β 1 1.40 +/− 2.71 +/− 1.99 +/− 2.11 +/− 0.00 +/− mRNA- 0.51 0.48 0.44 0.26 0.35 Conc. [0077] [0077] TABLE 2 PIIICP4.1 PIIICP4.1 PIIICP4.1 (50 (150 (500 Fibrosis Intact Group μg/ml) μg/ml) μg/ml) Control Control Final Body 25.88 +/− 25.33 +/− 26.00 +/− 24.50 +/− 29.63 +/− Weight (g) 0.30 0.88 0.856 1.17 0.38 Liver Weight 6.94 +/− 7.01 +/− 7.66 +/− 6.83 +/− 5.62 +/− (g/100 g 0.26 0.27 0.29 0.31 0.22 body weight) GIDH 589 +/− 522 +/− 578 +/− 867 +/− 32 +/− Activity (U/ 77 33 115 126 14 ml serum) (p < 0.05) Collagen α 1 2.27 +/− 2.20 +/− 1.98 +/− 1.79 +/− 0.00 +/− (III) mRNA- 0.17 0.42 0.34 0.52 0.30 Conc. Collagen α 1 3.85 +/− 3.58 +/− 3.72 +/− 3.25 +/− 0.00 +/− (I) mRNA- 0.21 0.46 0.41 0.58 0.41 Conc. BRIEF DESCRIPTION OF DRAWINGS [0078] [0078]FIG. 1 (I) depicts the amino acid sequence around the human C-terminal procollagen (III) propeptide (PIIICP). The N-terminal end of the prosequence is formed by the procollagen C-proteinase cleavage site (designated by the arrow). The propeptide sequence itself is printed in bold letters. The section of the sequence in the vicinity of the the procollagen C-proteinase cleavage site is underlined. FIG. 1 (II) shows the amino acid sequence around the human N-terminal procollagen (III) propeptide (PIIINP). The N-terminal end of the prosequence borders to the presequence. The procollagen N-proteinase cleavage site is designated by an arrow. The propeptide sequence itself is printed in bold letters. The part of the sequence in the vicinity of the the procollagen N-proteinase cleavage site is underlined. [0079] [0079]FIG. 2 shows the time course of PIIICP serum concentrations in the model of the anaesthetized rat. The terminal half life time was approximately 80 min, the terminal distribution volume was at approximately 7.4 l/kg and the elimination rate at approximately 6.3 l/(h*kg). For details refer to example 3 of the present invention [0080] [0080]FIG. 3 shows (A) the fraction of the collagen area with respect to the total area and (B) the CTGF mRNA concentration after chronic application of various procollagen α 1 (III) propeptides in the mouse CCl 4 model (mean±SEM). [0081] [0081]FIG. 4 shows (A) the fraction of the collagen area with respect to the total area and (B) the CTGF mRNA concentration after chronic application of different concentrations of the PIIICP4.1 protein in the mouse CCl 4 model (mean±SEM). For details refer to example 4 of the present invention. [0082] [0082]FIG. 5 shows immunohistochemical studies on the locali ention.of the PIIICP antigen on representative sections from rat livers. The monoclonal antibody 48D19 was used. (A) intact control after 7 days of infusion of a buffer control solution (240-fold magnification); (B) CCl 4 -induced liver fibrosis after 7 days of infusion of PIIICP protein (400-fold magnification C; (C) CCl 4 -induced liver fibrosis after 7 days of infusion of a buffer control solution (fibrosis control, 320-fold magnification). DETAILED DESCRIPTION [0083] In this description a number of documents are cited. The disclosed content of these documents, including instructions of the manufacturer, is hereby incorporated by reference. [0084] In the examples “v/v” denotes volume percentage and “w/v” denotes weight percentage. EXAMPLE 1 Purification of PIIICP from Inclusion Bodies in E. coli [0085] PIIICP was produced in the form of inclusion bodies in E. coli (Burchardt 1998). The cell pellets from three 200 ml cell cultures were resuspended in 24 ml 50 mM Tris-HCl (pH 8.0) 1 M NaCl, frozen over night at 20° C. and centrifuged at 5,000 g for 10 minutes after thawing. 4.8 ml of the same buffer were added to the precipitate and 4.8 ml of a 25 mM Tris-HCl (pH 8.0), 5 mg/ml lysozyme as well as 4.8 ml of a 0.5 M EDTA solution (pH 8.0) were added. After 1 hour of incubation at 37° C. the bacteria cells were disintegrated by ultrasonification. Subsequently, 12 ml of 10% Triton-X-100, 1 mM EDTA, dissolved in 50 mM Tris HCl (pH 8.0), were added and after 30 min of incubation the mixture was centrifuged at 5,000 g for 10 minutes. The unsoluable fraction was dissolved by ultrasonification in 24 ml 5% Triton-X-100, dissolved in 50 mM Tris-HCl (pH 8.0), incubated at 37° C. one more time and was again centrifuged at 5,000 g for 10 minutes. The triton extraction was repeated once to remove the membrane lipids. Subsequently, the pellet was dissolved by ultrasonification in 24 ml 1 M urea, 1 mM EDTA, dissolved in 50 mM Tris HCl (pH 8.0) and centrifuged again after 30 minutes of incubation (5,000 g, 10 min). The pellet almost entirely consisted of almost pure PIIICP in the form of inclusion bodies. The protein could be dissolved in 6 M urea, in turn dissolved in 50 mM Tris-HCl (pH 8.0). When the sample was centrifuged for 30 minutes at 15,800 g, the inclusion body protein remained in the supernatant. EXAMPLE 2 Renaturation of recombinant collagen α 1(III) propeptides. [0086] As an example, recombinant human PIIICP4.1 was renatured, the production of which was described in Burchardt, 1998, and in the patents: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1). Furthermore, recombinant human PIIINP 4.5.2 was renatured, the production of which was described in the patent: Monoclonal antibody and assay for detecting PIIINP (WO 99/61477A2). Finally, recombinant murine PIIINP, the production of which was described in Kauschke, 1999, was renatured using the method described below. [0087] However, the method is not limited to the renaturation of these exemplary propeptides, but is suitable for the renaturation of other procollagen propeptides and similar compounds. [0088] Method. [0089] Used Buffers. [0090] A) Dialysis Buffer. [0091] 300 mM Trizma-Base, pH 7.4. [0092] 400 mM L-Arginine. [0093] 10 mM EDTA. [0094] 0.4 mM Pefabloc SC. [0095] 1 mM Glutathione reduced. [0096] 0.1 mM Glutathione oxidized. [0097] B) Limited Dilution Buffer. [0098] 50 mM Trizma-Base, pH 7.4. [0099] 800 mM L-arginine. [0100] 10 mM NaCl. [0101] 10 mM EDTA. [0102] 0.4 mM Pefabloc SC. [0103] 1 mM Glutathione reduced. [0104] 0.1 mM Glutathione oxidized. [0105] Collagen α 1 (III) propeptides can be dissolved in 6 M urea buffer. In a limited dilution step the buffer conditions were abruptly altered for the proteins. A redox system present in the buffer facilitated the formation of disulfide bridges. To this effect, the protein solution was added dropwise to a surplus of ice-cold limited dilution-buffer while being gently shaken. This solution was stored over night at 4° C. [0106] All dialysis steps were performed at 4° C. At every step the dialysis was performed for at least three hours and against a one-hundredfold buffer volume. The limited dilution solution was transferred into a tube of suitable pore size and dialyzed against the dialysis buffer. In the following dialysis steps the L-Arginine concentration was lowered to 100 mM, subsequently a buffer without L-Arginine was used. In addition, the fourth buffer was lacking the Glutathione redox system. The final buffer was chosen according to the intended use. For in vivo experiments, for example, it consisted of 10 mM Trizma-Base, pH 7.4, 145 mM NaCl. The dialysate was finally stored at 4° C. EXAMPLE 3 Measurement of the Elimination Kinetics of Renatured PIIICP in the Anaesthetized Rat. [0107] Materials and Methods. [0108] PIIICP-Plate-ELISA: The determination of PIIICP concentrations in biological samples was carried out with a sandwich ELISA assay. Two monoclonal anti-PIIICP antibodies were used (Burchardt, 1998). [0109] As a catching antibody, antibody 48B14 (Burchardt, 1998) was immobilized on an ELISA plate at a concentration of 5 μg/ml. After blocking free unspecific binding sites on the plate by incubation with a 3% (v/v) BSA solution, biological samples or buffered solutions with known PIIICP concentrations were added together with a known concentration of a FITC-labelled secondary antibody (48D19) (Burchardt, 1998) for 30 minutes to the immobilized secondary antibody. Remaining free PIIICP antigen and free secondary antibody were subsequently removed by washing steps and the amount of bound, labelled secondary antibody was determined. The aforementioned antibodies can be replaced by other anti-PIIICP antibody couples that can be produced according to commonly used practices. [0110] The measured in vivo concentrations in human serum were for the most part below the limit of detection (below 0.5 ng/ml, see the patent application: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1)). These results are almost an order of magnitude below the phsysiological PIIINP concentrations in human serum. [0111] Animal experiment: Fastened Sprague-Dawley rats with a body weight of approximately 300 g were anaesthetized by intraperitoneal administration of Trapanal at 100 mg/kg body weight. [0112] Fluids or dilutions of the substances were applied through a catheter placed into the jugular vein. The measurement of the blood pressure as well as the drawing of blood were performed via a femoral artery catheter. To facilitate spontaneous breathing the tracheae of the animals were canalized. During the experiments the animals received infrared heat radiation. After initiation of the surgical procedures, the animals received 5 ml of physiological salt solution per kg body weight as a bolus to compensate for the loss of blood. After a recovery period of 15 minutes, the substance dilutions in physiological buffer (10 mM Trizma-Base, pH 7.4, 145 mM NaCl) were administered for 2 hours by continuous infusion of renatured PIIICP4.1 (Burchardt, 1998) at a flow rate of 100 μl per kg body weight and minute (The PIIICP4.1 concentration in the infusion solution was. approximately 150 μg/ml). Blood samples were drawn after 2 min, 60 min, 115 min, 150 min, 180 min and 225 min after the start of the infusion. This was paralleled by a recording of the blood pressure. At each time point 400 μl of blood were drawn and immediately 20 μl of heparin (250 IE/ml) were added, the sample was centrifuged at high speed and the plasma was stored at 20° C. until testing. After the experiment the experimental animals were sacrifized by application of a KCl solution. The pharmacokinetic parameters were determined subsequent to the PIIICP concentration measurements in the samples. [0113] Results. [0114] The terminal half life time was determined as approximately 80 minutes. In the terminal area of the curve approximately 6.1% of the total area were under the curve. The distribution volume in the terminal phase was at approximately 7.4 l/kg and the rate of elimination was determined at approximately 6.3 l/h/kg (see FIG. 2). EXAMPLE 4 Demonstration of the Biological Efficacy of PIIICP and PIIINP. [0115] The biological efficacy of the compounds can be demonstrated in cell culture assays and in vivo. For example, after addition of the inhibitors to human cell lines, a drop in the concentration of free α 1(III) propeptide in the supernatant can be measured because the peptide is released by the enzymatic activity of PCP. To measure PIIICP concentrations in the supernatant a recently established assay can be used (Burchardt, 1997, and patent application: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1)). [0116] In this patent the biological efficacy of PIIICP4.1 (production described in Burchardt, 1998, and in the patents: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1), purification and renaturation described above in this patent as an example); of PIIINP4.5.2 (production described in the patent: Monoclonal antibody and assay for detecting PIIINP (WO 99/61477A2), renaturation described above in this patent as an example) and of murine recombinant PIIINP (production described by Kauschke, 1999, renaturation described above in this patent as an example) are described as examples in the model of the CCl 4 -induced liver fibrosis of the mouse. [0117] For PIIICP the antifibrotic effect of 3 different doses of this compound in this animal model is described as an example. [0118] Depending on the organ manifestation or the kind of fibrotic damage animal models with other fibrosis manifestations, for example in the heart, in the kidney, in the lungs, in the skin, or in other organs can be used. [0119] In the example of the CCl 4 -induced liver fibrosis of the mouse the reduction of the collagen deposition brought about by PIIICP and PIIINP is described by quantitative morphometry. It can also be carried out by determination of the hydroxyprolin content of the fibrotic organs or by quantitative morphometry (Kauschke, 1999). In addition, the organ-protective effective effect of PIIICP and PIIINP by reduction of cell damage is described in the example, as determined by measurement of the activities of intracellular marker enzymes (e.g. GIDH). The measurement of the organ-protective effect can also be carried out in a different way, for example by measurement of inhibition of the extent of apoptosis or necrosis or such. [0120] Materials and Methods. [0121] Animal experiments: The experimental animals received 0.2 ml per 100 g body weight of a mixture of CCl 4 and mineral oil in a ratio of 1:8 twice per week. The substance was administered by daily intraperitoneal application of 0.5 ml of a dilution of the substance. The fibrosis- and the intact-controls received a buffer control solution without procollagen propeptides. The animals had free access to standard diet and water during the whole experiment. The body weight of the animals was measured at the beginning and at the end of the experiment. Upon termination of the experiment the wet weight of the liver was determined, the liver was portioned for the subsequent experiments and immediately shock-frozen in liquid nitrogen. It was stored until use at 80° C. In addition, plasma samples were drawn from the experimental animals to determine clinical chemistry parameters with them. [0122] Total collagen staining with Sirius Red/Fast Green: 14 μm frozen sections were dried over night. After a 10 minute treatment with a 10% (v/v) formaldehyde solution the slices were washed twice for 5 minutes with H 2 O dest., respectively. The Picrosirius Red staining was carried out for 30 minutes at room temperature in a 0.1% (w/v) Sirius Red solution in saturated picric acid (per 400 ml a PBS tablet and 10 ml of concentrated acidic acid were added). The sections were again washed with H 2 O dest. twice and subsequently stained in a 0.1% (w/v) Fast Green solution in saturated picric acid (per 400 ml a PBS tablet and 10 ml of concentrated acidic acid were added). The unstaining and dehydratization steps consisted of a sequence of washing steps: 10 seconds H 2 O dest., 10 seconds 70% (v/v) ethanol, a minute 80% (v/v) and 90% (v/v) ethanol, respectively, three times with pure ethanol for two minutes, respectively. Before they were covered with the Leica CV Mount, the sections were washed three times in xylol for 5 minutes. [0123] Total RNA preparation from tissue: Approximately 20 mg of tissue were pulverized in liquid nitrogen and transferred into an Eppendorf tube. 600 μl of RLT buffer (with 0.1% (v/v) β-mercaptoethanol) were added to the powdered tissue, mixed to homogeneity, and the mixture was applied on a QIAshredder column. The column was centrifuged at 18,000 g and 4° C. for 2 minutes. The retained solid constituents were discarded, and the flow through was further used. The subsequent processing steps were carried out with the RNeasy Total RNA Kit (Qiagen, Hilden) according to the manufacturer's recommendations. The elution steps was carried out with 35 μl of RNase-free H 2 O. The RNA content of each preparation was determined directly thereafter in an aliquot, a further aliquot was examined for the integrity of the obtained RNA bands using an RNA formaldehyde agarose gel. The samples were stored at 80° C. until use. [0124] cDNA synthesis from total RNA: The synthesis of cDNA from the prepared total RNA samples was performed with the SuperScript preamplification system according to the manufacturer's (Gibco BRL) recommendations in all cases. All working steps were carried out on ice. In all cases, 1 μg of total RNA and master mixes were used. Before the reverse transcription potentially present impurities consisting of genomic DNA were removed from all samples by digestion with DNase I. For this purpose 1 μg of total RNA solution was brought up to a volume of 8 μl with RNase-free water, 1 μl of DNase I solution (Superscript kit) and 1 μl of 10× buffer were added and the digest was incubated for 10 minutes at room temperature. The DNase I digest was stopped by the addition of 1 μl of 25 mM EDTA solution and subsequent incubation (10 minutes at 65° C.). The whole volume was used in the cDNA synthesis. Subsequent to the cDNA synthesis the volume was brought up to 100 μl total volume with DNase-free water and stored at 80° C. until use. In all cDNA synthesis procedures, controls without the addition of reverse transcriptase were carried out randomly to check for contaminations consisting of genomic DNA. [0125] Determination of mRNA concentrations by a TaqMan PCR analysis: The determination of specific mRNA concentrations was carried out by a TaqMan analysis. During the PCR reaction a specific hybridizing fluorescent probe is cleaved by the exonuclease activity of the Taq polymerase—and the resulting fluorescent signal is measured in real time. The results are presented as the number of cycles when the measured specific fluorescent signal exceeds the threshold value for the first time. Smaller ct values indicate that a higher specific mRNA concentration had been present in the original sample. Maximally achievable is a doubling of the amount of product during each cycle. By choosing suitable primers and probes, and a small length of the amplified sequence, approximately a doubling of the amount of product can be assumed in each PCR cycle during the exponential phase of the reaction. Consequently, using the measured differences in the ct values, differences in the mRNA concentrations of the respective transcript in the original sample can be calculated after calibration. Thus, a calibrated difference of 3 ct units means that the mRNA concentrations of this transcript are differing from the reference samples by a factor of 8(=23) when the assumption of a doubling of the amount of product during each PCR cycle is valid. [0126] With regard to the mRNA concentrations, all measured mRNA concentrations were calibrated based on the respective HPRT mRNA concentration. For the HPRT mRNA concentration it was possible to show that it remains unaltered during the course of a fibrotic disease and that HPRT can be used as a standard, meaning as a reference level. [0127] All primers and probes were so chosen, with respect to their localization on the gene and to the expected amplification product, that a doubling of the concentration of the product in each cycle was to be expected in the course of a TaqMan PCR reaction. These assumptions were checked by control experiments before and verified. The primers and the 6-FAM-labeled probes were all present at concentrations of 100 μM. To prevent variability between the different incubations master mixes were used in all cases and every incubation was carried out at least in duplicate. Determinations of every single transcript were carried out for all samples on the same plate. In all experiments, control experiments without template or without previous reverse transcription were carried out. All work was performed on ice. The master mix contained 12.5 μl of the TaqMan Universal Master Mix (Roche), 7.5 μl of the primer-probe-mix (1 μM with respect to each primer and 0.5 μM probe in DNase/RNase-free water) as well as 3.75 μl DNase/RNase-free water. Per determination, 2.5 μl cDNA solution were pipetted into 96 well plates with optical lids and mixed with 22.5 μl of the master mix. The plates were centrifuged for 1 minute at 500 g and 4° C. The program of the TaqMan PR reaction encompassed a heating phase of 2 minutes at 50° C., a 10 minute denaturing step at 95° C. as well as 40 cycles with a denaturing step at 95° C. for 15 seconds and a combined one minute annealing/expansion step at 60° C. Within the cycles, the fluorescence of the liberated fluorescent probe was measured automatically at the time point of the denaturation step. The evaluation was carried out with the ABI PRISM Sequence Detection Software. The baseline was set at the mean of cycles 3 and 15, the threshold was 0.04. [0128] Results. [0129] Effects of the infusion of procollagen (III) propeptides in the chronic i.p. experiment in the mouse CCl 4 model: To investigate the effect of the recombinantly produced procollagen α 1(III) propeptides on the formation of an experimentally induced liver fibrosis groups of 10 mice were treated with CCl 4 only or with protein solutions at concentrations of 500 μg/ml, respectively. In addition, one group received buffer control solution only (intact control). As therapeutic recombinant proteins, human PIIICP4.1 (production described in Burchardt, 1998, and in the patent applications: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1)), purification and renaturation described above in this patent application as an example); complete human PIIINP4.5.2 (production described in the patent: Monoclonal antibody and assay for detecting PIIINP (WO 99/61477A2); renaturation described above in this patent as an example); and murine PIIINP containing 18 amino acid residues of the prosequence (designated M1, production described by Kauschke, 1999, renaturation described above in this patent application as an example) were used. [0130] At the end of the treatment the dissolved PIIICP in the infusion solution was not degraded in all cases. This was demonstrated with an SDS PAGE gel. [0131] In all animals, the relative collagen area with respect to the total area was determined morphometrically in liver sections as well as the GIDH activity in the serum and the mRNA concentration of selected transcripts by a TaqMan analysis. [0132] The proteins were well tolerated by the animals over the studied time period in the concentrations used. There were no pathologic signs, furthermore an increased mortality did not occur. [0133] The morphometrically determined relative collagen area with respect to the total area, as determined by automated analysis of the Sirius Red-stained area, showed the highest values in the fibrosis control group (Kauschke, 1999). In the treatment groups the relative collagen area with respect to the total area was significantly reduced in all cases (FIG. 3A). With PIIICP4.1, to 71% of the fibrosis control (p<0.04); with PIIINP4.5.2 to 63% of the fibrosis control (p<0.01); and with M1 to 68% of the fibrosis control (p<0.02). [0134] When the CTGF mRNA concentrations in the liver are regarded, a significant reduction in concentration in the treatment groups in comparison to the fibrosis control was observed (FIG. 3B). The differences were approximately +1.9 Δ ct-units (PIIICP4.1, p<0.001), approximately +1.5 Δ ct-units (PIIINP4.5.2, p<0.01), and approximately +1.2 Δ ct-units (M1, p<0.02). [0135] The GIDH serum activity was also reduced in all treatment groups in comparison to the fibrosis control (Table 1) (Kauschke 1999). The serum activities were 17% (PIIICP 4.1) or 11% (PIIINP4.5.2, M1), respectively, lower than in the fibrosis control. Due to individual variations the differences did not reach the level of significance (p<0.05) in any case. [0136] In all cases with CCl 4 application a reduction in body weight (Table 1) was observed. Differences between the treatment groups and the fibrosis control were not observed. [0137] The relative liver weight was above the intact controls in all CCl 4 groups. Treated animals tended to present with slightly higher relative liver weights in comparison to the fibrosis control. The absolute liver weights were not significantly different among the groups (Table 1). [0138] The mRNA concentrations of the transcripts for collagens type III and type I, TGF β 1 (Table 1) as well as for lysyl oxidase, MMP-1, PAI-1, and tenascin (data not shown) revealed no significant differences between the fibrosis control group and the treatment groups receiving the procollagen α 1 (III) propeptide applications. [0139] More detailed studies on the in vivo effects of the recombinantly produced PIIICP 4.1 protein: To investigate the effect of the recombinantly produced procollagen α 1 (III) propeptides (production described in Burchardt, 1998, and in the patent applications: An immunoassay for procollagen-III-C-terminal propeptide (WO 99/24835A2 and EP00988964A1), purification and renaturation described above in this patent application as an example) on the formation of an experimentally induced liver fibrosis were carried out in the mouse CCl 4 model. [0140] Groups of 8 mice were treated with CCl 4 only (fibrosis control), or additionally with PIIICP4.1 protein solutions with concentrations of 50 μg/ml PIIICP4.1, of 150 μg/ml and of 500 μg/ml over a period of 14 days, respectively. In addition, on group was treated with buffer solution only (intact control). [0141] At the end of the treatment the dissolved PIIICP in the infusion solution was not degraded in all cases. This was demonstrated with an SDS PAGE gel. [0142] In all animals, the relative collagen area with respect to the total area was determined morphometrically in liver sections, as well as the GIDH activity in the serum and the mRNA concentrations of selected transcripts by TaqMan analysis. [0143] The proteins were well tolerated by the animals over the studied time period in the concentrations used. There were no pathologic signs, furthermore an increased mortality did not occur. [0144] In all animals with CCl 4 application a reduction in body weight was observed in comparison with the untreated control animals at the end of the experiment (Table 2). However, when comparing between the fibrosis control and the PIIICP groups significant differences were not observed. There was merely a tendency towards higher body weights in the animals receiving PIIICP applications, independently of the received concentration. [0145] The relative liver weight was higher in all CCl 4 -treated groups than in the untreated intact control. There were no significant differences when the single treatment groups were compared to the fibrosis control (Table 2). [0146] When the total collagen deposition as determined by automatic analysis of the Sirius Red-stained areas is regarded, significant differences between the different groups of animals were revealed (FIG. 4A). After chronic treatment with i.p.-injected renatured PIIICP4.1 solution a reduction in the total collagen area was measured in all treatment groups. In the treatment groups with the lowest PIIICP dose (50 μg/ml) the total collagen area was reduced significantly by 32% in comparison with the fibrosis control (p<0.05). After a treatment with 150 μg/ml PIIICP 4.1 the significant reduction was 44% with respect to the fibrosis control (p<0.02). The treatment group with the highest protein concentration (500 μg/ml PIIICP 4.1) exhibited marked variations of the measured total collagen area within the treatment group and showed a reduction of the total collagen area by 31%. The level of significance (p<0.05) was not reached in comparison with the fibrosis control. [0147] The clinical parameter GIDH activity was determined in the serum in parallel as a measure of the degree of cell damage and was markedly reduced in the groups that received additional PIIICP4.1 protein solution in comparison with the fibrosis control (Table 2). After chronic treatment with 50 μg/ml PIIICP4.1 GIDH serum activity was 68% of the activity in the fibrosis control, after 150 μg/ml PIIICP it was at approximately 60% of the fibrosis control and after 500 μg/ml it was at approximately 67% of the fibrosis control. Only at 150 μg/ml was the reduction significant in comparison with the fibrosis control (p<0.05). In the other two treatment groups the level of significance was not reached due to variations of the results from one animal to the other, respectively. [0148] After calibration based on HPRT, differences between the intact control animals (without CCl 4 application) and the fibrosis control were observed with all transcripts (collagen type I, collagen type III, tenascin, PAI-1, MMP-1, lysyl oxidase, and CTGF). All examined transcripts were genes that participate in the synthesis of the extracellular matrix. Consequently, the mRNA concentrations were on the average by the factor of 6 to 10 higher in the fibrosis controls than in the intact controls. [0149] Significant differences between those animals that were treated with PIIICP4.1 in addition to the CCl 4 damage and the fibrosis control were measured for the CTGF transcript among all examined transcripts (FIG. 4B). At 50 μg/mIPIIICP4.1 the difference was at approximately +0.74 Δ ct-units (p<0.04), at 150 μg/ml at approximately +0.75 Δ ct-units (p<0.05) and at 500 μg/ml PIIICP4.1 at approximately +1.41 Δ ct-units (p<0.02). EXAMPLE 5 Immunohistochemical detection of PIIICP on liver sections. [0150] Materials and Methods. [0151] Liver fibrosis model of the bile duct-ligated rat: In fastened female Sprague-Dawley rats the main bile duct was isolated after medial opening the upper abdomen medially during barbiturate anaesthesia. By means of an inserted catheter the bile duct system was occluded by the application of approximately 0.1 ml Ethibloc per animal. The bile duct was subsequently ligated distally and proximally and dissected. Intact control animals were also operated, the bile duct system was not occluded, however. [0152] The PIIICP4.1 application (production described in Burchardt, 1998, and in the patent applications: An immunoassay for procollagen-Ill-C-terminal propeptide (WO 99/24835A2 and EP00988964A1), purification and renaturation described above in this patent application as an example) was performed by a permanent venous infusion via an implanted permanent catheter. [0153] The implantation of a femoral vein catheter was performed in parallel to the bile duct occlusion. For this purpose the skin was opened in the right inguinal region and the femoral vein was atraumatically isolated and fixated by two ligatures. After incision a venous catheter was inserted towards the heart and fixated. The catheter was subsequently directed towards the collar subcutaneously by means of a trocar and the surgical wound was closed by a skin suture. The venous catheter was connected to a rotation adapter by a necklace through a protective spiral. It was coupled to an infusion pump. For infection prophylaxis 0.1 ml of Tardomycel were applied subcutaneously following the surgery. [0154] The initiation of the PIIICP4.1 infusion at a concentration of 300 μg/ml took place 24 h after the surgery. The intact—and fibrosis controls received buffer control infusions. The infusion was performed at a rate of 0.2 ml per hour over a time period of seven days. The infusion solution was kept cool (approximately 7° C.) over the entire time period of the experiment. [0155] The rats were kept in a round cage with free access to standard diet and water. The body weight of the animals was recorded at the beginning and at the end. At the end of the experiment the liver was portioned for subsequent experiments and immediately shock-frozen in liquid nitrogen and stored at −80° C. until use. [0156] Fixation of the tissue for immunohistochemistry: For immunohistochemical studies the tissues were fixated for 24 h in a 3.6% formaldehyde solution (v/v). After washing with destined water the water was extracted with increasing concentrations of ethanol and the tissues were embedded in paraffin at 52° C. [0157] Immunohistochemistry: 5 μm paraffin sections were deparaffinized. For this purpose the sections were immersed successively in xylol, pure ethanol, and in a concentration series of an ethanol-water mixture (90% (v/v), 80% (v/v) 70% (v/v)) and subsequently transferred into pure water. After a five minute treatment with 3.6% (v/v) H 2 O 2 they were washed with destined H 2 O. Subsequently they were washed for five minutes with PBS. Blocking was performed for 20 minutes in a solution of 5% (w/v) dry milk powder and in 1% (w/v) BSA in PBS. After washing twice for three minutes in PBS the primary antibody (monoclonal mouse anti-PIIICP-antibody 48D19) was added at a concentration of 4 μg/ml in PBS and incubated for an hour at room temperature. After two further washing steps the next steps were performed according to the ExtrAvidin Staining Kit (Sigma Aldrich). The sections were incubated with biotinylated anti mouse IgG's in a 1:15 dilution in PBS with 1% (w/v) for 20 minutes at room temperature. After two washing steps they were treated with a 1:15 dilution of ExtrAvidin Peroxidase for 20 minutes at room temperature. This dilution was prepared using PBS with an addition of 1% (w/v) BSA. Following two washing steps the sections were developed for 10 minutes with the DAB system (1 tablette per 5 ml of water, respectively) (Sigma Aldrich). Residual staining solution was removed with H 2 O dest. The counterstaining of the cell nuclei was performed using hematoxylin. The tissue sections were placed into acidic Mayer's hematoxylin (1:4 dilution in H 2 O dest.), the stain was subsequently washed out with H 2 O dest. The sections were rinsed with tab water for 5 minutes to develop the bluish color of hematoxylin. After a washing step with H 2 O dest. the sections were dehydrated. Using aqueous ethanol solutions of increasing concentrations the water was extracted (70% (v/v), 80% (v/v), 90% (v/v), finally three times with pure ethanol). The dehydrated sections were washed three times with xylol for 5 minutes and were embedded with the Leica CV Mount artificial resin. [0158] Results. [0159] [0159]FIG. 5 shows immunohistochemical studies with the anti-PIIICP antibody 48D19 on representative sections from rat livers. A liver fibrosis was induced by a bile duct ligation. Subsequently, a PIIICP protein solution or a buffer control solution was infused for a period of 7 days through a permanent catheter. [0160] In the intact control, namely sham-operated animals infused with a buffer control solution, immunohistochemical staining with the PIIICP antibody was hardly discernable (FIG. 5A). [0161] The fibrosis control revealed heavy damages to the liver (FIG. 5C). A massive proliferation of the bile ducts was observed in the damaged livers. In the area of the hepatic sinoids single cells, that proved positive for smooth muscle cell actin (α-SMA) on control sections, were stained heavily. They were transformed hepatic stellate cells which were stained selectively. The hepatic sinoids were markedly reduced in their perfusion capacity. A staining of hepatocytes was not observed. [0162] On sections from animals with bile duct ligation and PIIICP infusion a strong intracellular staining of hepatic stellate cells was also observed (FIG. 5B). In contrast to the fibrosis control, these cells showed additional intracellular staining in the shape of granula. This intracellular staining was in these cases also detected in hepatocytes with access to the sinoids. As far as can be seen, there was no specific immune reaction in the cell nucleus. The extent of fibrosis was less than in the fibrosis control. LITERATURE [0163] Burchardt E R et al. Monoclonal antibody and assay for detecting PIIINP. WO 99/61477A2. [0164] Burchardt E R et al. An immunoassay for procollagen-III-C-terminal propeptide. WO 99/24835A2 and EP00988964A1. [0165] Burchardt E R, Schr ö der W, Heke M, Kohlmeyer J, Neumann R, Kroll W (1997) Expression cloning of C-terminal procollagen (III) propeptide and its use in a novel serum assay to monitor liver fibrogenesis. Hepatology 26: 487A. [0166] Burchardt E R, Heke M, Kauschke S G, Harjes P, Kohlmeyer J, Kroll W, Schauer M, Schroeder W, Voelker M (1998) Epitope-specific monoclonal antibodies against human C-terminal procollagen α 1 (III)-propeptide. Matrix Biology 17: 673-677. [0167] Kauschke S G, Knorr A, Heke M, Kohlmeyer J, Schauer M, Theiss G, Waehler R, Burchardt E R (1999) Two assays for measuring fibrosis: RT-PCR of collagen alpha1 type III is an early predictor of subsequent collagen deposition while a novel N-terminal procollagen (III) propeptide assay reflects manifest fibrosis in CCl 4 -treated rats. Analytical Biochemistry 275: 131-140.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] Not Applicable. BACKGROUND OF THE INVENTION [0003] The present invention relates in general to endoscopic harvesting of blood vessels, and, more specifically, to reducing endothelial damage resulting from dissection, cauterizing, and handling of a target vessel. [0004] In coronary artery bypass grafting (CABG), a blood vessel or vessel section, such as an artery or vein, is “harvested” (i.e., removed) from its natural location in a patient's body for use as a graft. After removal, the section of blood vessel is joined between an arterial blood source and the coronary artery that is to be bypassed. Among the preferred sources for the vessel to be used as the bypass graft are the saphenous vein in the legs and the radial artery in the arms. [0005] Endoscopic surgical procedures for harvesting a section of a vessel (e.g., the saphenous vein) subcutaneously have been developed in order to avoid disadvantages and potential complications of older harvesting techniques wherein a continuous incision (e.g., along the leg) was made for the full length of the desired vessel section in order to provide adequate exposure for visualizing the vessel and for introducing surgical instruments to sever, cauterize, and ligate the tissue and side branches of the vessel. One such minimally-invasive technique employs a small incision for locating the desired vessel and for introducing one or more endoscopic harvesting devices. Primary dissection occurs by introduction of a dissecting instrument through the incision to create a working space and to separate the vessel from the surrounding tissue. Then a cutting instrument is introduced into the working space to sever the blood vessel from the connective tissue surrounding the section to be harvested and any side branches of the blood vessel. The branches may be clipped and/or cauterized. [0006] In one typical procedure, the endoscopic entry site is located near the midpoint of the vessel being harvested, with dissection and cutting of branches proceeding in both directions along the vessel from the entry site. In order to remove the desired section of the blood vessel, a second small incision, or stab wound, is made at one end thereof and the blood vessel section is ligated. A third small incision is made at the other end of the blood vessel section which is then ligated, thereby allowing the desired vessel section to be completely removed through the first incision. Alternatively, only the first two incisions may be necessary if the length of the endoscopic device is sufficient to obtain the desired length of the blood vessel while working in only one direction along the vessel from the entry point. [0007] An example of a commercially available product for performing the endoscopic vessel harvesting described above is the VirtuoSaph™ Endoscopic Vein Harvesting System from Terumo Cardiovascular Systems Corporation of Ann Arbor, Mich. Endoscopic vessel harvesting systems are described in U.S. Pat. No. 8,465,488 to Maeda et al and U.S. Pat. No. 7,547,314 to Kadykowski, both of which are incorporated herein by reference in their entirety. After harvesting, the vessel is inspected and prepared for surgery by checking for leaks or other defects. The prepared vessel is then stored in a preservative fluid until needed. U.S. Pat. No. 8,123,672 discloses a kit for preparing and preserving a blood vessel for bypass graft surgery. [0008] In the VirtuoSaph™ System, the cutting tool for severing and cauterizing branches has the form of a V-cutter wherein a V-shaped tip at the distal end of the cutter guides a branch to be cut into a longitudinal slit. Electrodes adjacent the slit are electrically energized with a high frequency voltage in order to cauterize and sever the branch by coagulation. Unfortunately, a cascade of biochemical events within the tissue can affect the endothelium. It would be advantageous if the cascade of events could be minimized with respect to the endothelium in order to improve the long term patency of vessels used as coronary artery bypass grafts. SUMMARY OF THE INVENTION [0009] In one aspect of the invention, an endoscopic vessel harvester comprises a longitudinal insertion member having a proximal end with a handle and a distal end adapted for insertion into a tunnel dissected along a target vessel within a body of a patient. A vessel keeper is extendably mounted at the distal end of the insertion member comprising a capture frame with a movable side having an opened position to admit the target vessel and having a closed position to slidably capture the target vessel. A cutter member is extendably mounted at the distal end of the insertion member having a cauterizing element adapted to contact side branches of the target vessel and to cut and cauterize the side branches while the target vessel is slidably captured in the vessel keeper. A spray nozzle is carried by the vessel keeper. A preservative distributor includes a manual control valve and a conduit between the valve and the spray nozzle adapted to deliver a preservative fluid to the target vessel proximate a respective side branch immediately after being cauterized. Thus, a harvested vessel is bathed in preservative fluid prior to being actually removed from the body, lessening endothelial damage arising from cascading biochemical events. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a side view of a vessel harvester of the invention. [0011] FIG. 2 is a top view of the distal end of the vessel harvester. [0012] FIG. 3 is a perspective view of the distal end of the harvester. [0013] FIG. 4 is an endoscopic view of the harvester inside the body of a patient during harvesting of a vessel. [0014] FIG. 5 is a perspective view of the cutter member and an irrigator for flushing debris from the cutter member. [0015] FIG. 6 is an end view of the embodiment of FIG. 5 . [0016] FIG. 7 is a block diagram showing the shared supply of preservative fluid for bathing the target vessel and flushing the cutter member. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0017] FIG. 1 shows a harvester rod 10 used to grasp the target vessel being dissected and to sever any branches or connective tissue connecting to the vessel. Harvester rod 10 is inserted into a working tunnel along a target vessel that is created using a dissector rod (not shown). Harvester rod 10 has a handle 11 connected to an elongated sleeve member or insertion member 12 and to an endoscope receiver 13 . At the distal end of insertion member 12 are a vessel-keeper (V-keeper) 14 which is a capture frame for retaining the vessel being dissected and a V-cutter 15 for severing side branches and connective tissue. V-keeper 14 is manipulated by V-keeper buttons 16 on handle 11 . V-cutter 15 is extended or retracted by manipulating a V-cutter extender button 17 on handle 11 . An endoscope wiper lever 18 may be provided on handle 11 for controlling a wiper that clears the end of the endoscope when the endoscope optics become covered by material from the body cavity. An insufflator tube 20 can be connected to a source of gas such as CO 2 to deliver insufflation gas to the distal end of insert member 12 . A bipolar cord 21 has a connector 22 at one end for connecting to a source of high frequency voltage, and includes conductors for supplying the voltage to electrodes on V-cutter 15 . [0018] V-keeper 14 and V-cutter 15 are shown in greater detail in FIG. 2 . V-keeper 14 includes a guide frame 25 mounted to a support rod 26 and a movable rod 27 . Guide frame 25 and rod 27 together form the capture frame with an internal opening 28 . The vein or other vessel to be harvested is maneuvered into opening 28 , and then the V-keeper buttons on the handle are manipulated to extend rod 27 along one side of the capture frame in order to close opening 28 and thereby retain the vessel. V-cutter 15 includes a V-tip 30 with a central slit mounted to an extendable guide 31 that is manipulated by the V-cutter button on the handle in order to place side branches into the slit. [0019] FIG. 3 shows the distal end of harvester rod 10 in greater detail. V-keeper 14 is longitudinally extendable as shown by arrow 37 while rod 27 is independently longitudinally extendable as shown by arrow 38 . In FIG. 3 , rod 27 is in an extended position used for maintaining the vessel being harvested within opening 28 (i.e., the side of the capture frame is closed). [0020] V-cutter 15 is longitudinally extendable in the directions shown by arrow 39 . Elongated insertion member 12 has a notch 40 with a terminal edge 41 which exposes V-cutter 15 prior to being extended further than the end of insertion member 12 . A guard piece 42 is provided beneath V-cutter 15 . A lens portion 43 at the end of the endoscope is shown positioned near the distal end of member 12 . A wiper 44 is mounted for pivoting over lens 43 as controlled by lever 18 ( FIG. 1 ) to wipe away debris from lens 43 . [0021] In the illustrated embodiment of FIGS. 1-3 , the invention provides distribution of a preservative fluid in the region of V-keeper 14 so that, after a cauterizing event, the preservative fluid can be delivered to the target vessel proximate to the cauterized area. The fluid locally bathes the target vessel, not only resulting in cooling of the vessel but also minimizing the usual cascade of biochemical events that affect the endothelium even before the vessel is removed from the body. Since the fluid would interfere with cauterization, it is only delivered after cauterization is complete at each particular position along the length of the vessel. [0022] As shown in FIGS. 2 and 3 , a spray nozzle 50 receives preservation fluid via a fluid conduit 51 passing through frame 24 and rod 26 . Nozzle 50 may be comprised of any suitable type of fluid exit with or without features for atomizing or otherwise dispersing an outflow of preservation fluid. By locating nozzle 50 on frame 25 (preferably oriented to spray fluid toward opening 28 ), the spray can be easily directed to a desired portion of the target vessel which is captured within opening 28 . Thus, after V-cutter 15 has been energized to cauterize a side branch, V-keeper 14 is put into a position from which the preservative fluid spraying out from nozzle 50 will bathe the target vessel in an area proximate to where the cauterization has occurred. The preservative fluid may preferably be a biocompatible aqueous solution such as an isotonic saline solution. The saline solution may be lactated (such as with a lactated Ringer's solution) or may include medications (such as with a papaverine solution). Solutions other than saline can also be used, such as a potassium-chloride solution. [0023] FIG. 4 is an endoscopic view as seen during vessel harvesting wherein a target vessel (e.g., saphenous vein) 55 is retained within opening 28 of V-keeper 14 within a cavity around vessel 55 created previously during blunt dissection. V-cutter 15 is in position for extending toward a side branch 56 for cauterizing and severing it to prepare a section of vessel 55 for removal. After cauterizing and severing branch 56 , V-keeper frame 25 is positioned to align spray nozzle 50 alongside vessel 55 proximate to cauterized branch 56 , and a supply of preservative fluid is activated in order to deliver a fluid spray 57 . Besides a cooling effect provided by the fluid, preservation of the functioning of the endothelium is initiated much sooner than in the prior art which did not apply any preservative until the target vessel was removed from the body. [0024] FIGS. 5 and 6 show a further embodiment of the invention wherein a fluid supply is simultaneously used within the harvester for the purpose of clearing debris from the V-cutter. Thus, an irrigator nozzle 61 is mounted to insertion member 12 at notch edge 41 . Nozzle 61 is in longitudinal alignment with a slit 60 in V-cutter 15 for dispensing a fluid to clean slit 60 when V-cutter 15 is moved to the inward position. FIG. 6 shows an end view wherein nozzle 61 is located directly above slit 60 . Preferably, nozzle 61 may be oriented to direct discharged fluid slightly downward in the figure. [0025] FIG. 7 shows V-cutter 15 retracted to its inward position facilitating the flow of fluid in a jet from nozzle 61 . A fluid distribution system is provided for sharing a supply of pressurized preservative fluid from a supply tank 65 . Aqueous fluid is delivered to V-keeper spray nozzle 50 ( FIGS. 2-4 ) by fluid conduit 51 passing through insertion member 12 from a first manually-controlled valve 66 which is connected to tank 65 . In parallel, irrigation nozzle 60 receives the aqueous fluid via a fluid conduit 62 passing through insertion member 12 . Conduit 62 selectably receives fluid via a second manually-controlled valve 67 connected to tank 65 . Tank 65 may preferably include a pump (not shown) for outputting a flow of saline solution to selectably generate sprays from nozzles 50 and 61 . The pump and valves 66 and 67 are operator controlled to coordinate creation of the spray with proper positioning of the V-keeper and/or the V-cutter. [0026] During an endoscopic procedure to harvest a vessel, the endoscopic vessel harvester is inserted into the body alongside the vessel to be harvested. The cutter is extended and the electrodes are energized (e.g., by a foot pedal operated by a surgeon) to individually sever a plurality of branches. Periodically (e.g., after each cauterizing event), valve 66 is manually activated in order to bathe the target vessel with preservative fluid in the area proximate to the severed branch(es). Repeated cutting operations may result in a buildup of debris in the longitudinal slit. The cutter is then retracted to a position longitudinally inward from its cutting position while maintaining the endoscopic vessel harvester in the body so that the debris may be cleared from the longitudinal slit by manually activating valve 67 to deliver a spray that flushes away the debris.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a divisional of U.S. patent application Ser. No. 12/874,863 filed Sep. 2, 2010 (now allowed) claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Ser. No. 61/239,974, filed Sep. 4, 2009, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to an intraocular lens, an intraocular lens system and a method of producing and/or implanting the lens or system in an eye wherein at least one intraocular lens includes a coating that aids in resisting interlenticular opacification (ILO). BACKGROUND OF THE INVENTION [0003] The human eye functions to provide vision by transmitting and refracting light through a clear outer portion called the cornea, and further focusing the image by way of a lens onto the retina at the back of the eye. The quality of the focused image depends on many factors including the size, shape and length of the eye, and the shape and transparency of the cornea and lens. [0004] When trauma, age, disease or other malady cause an individual's natural crystalline lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is often referred to as a cataract. The treatment for this condition is surgical removal of the natural crystalline lens and implantation of an intraocular lens (IOL). [0005] While early IOLs were made from hard plastic, such as polymethylmethacrylate (PMMA), soft, foldable IOLs made from acrylate based material have become increasingly popular because of the ability to fold or roll these soft lenses and insert them through a smaller incision. Such acrylate based lenses are particularly desirable because they exhibit excellent folding and unfolding characteristics during and upon implantation within the eye. Such acrylate lenses also exhibit desired biocompatibility characteristics. [0006] While typical procedures involve the implantation of only one lens in an eye, there are multiple situations where it is desirable to have a second or two lenses implanted. As one example, dual optic accommodative lenses have been developed to improve the focal range of IOLs. As another example, it may be desirable to, after insertion of a first IOL, implant a second IOL, referred to as piggyback lenses, to improve visual performance. [0007] While such two lens systems can improve visual performance, recent articles have suggested that various types of these lens systems may be susceptible to the development of interlenticular opacification (ILO). Such articles include: Gayton J L, Apple D J, Peng Q, et al., Interlenticular Opacification: A Clinicopathological Correction of a New Complication of Piggyback Posterior Chamber Intraocular Lenses , J. Cataract Refract. Surg., 2000; Eleftheriadis H, Marcantonio J, et al., Interlenticular Opacification in Piggyback AcrySof Intraocular Lenses: Explantation Technique and Laboratory Investigations , Br. J. Ophthalmol. 2001, July 85(7): 830-836; and Werner L., Mamalis N., et al., Interlenticular Opacification: Dual - Optic Versus Piggyback Intraocular Lenses , J. Cataract Refract. Surg. 2006, 32: 655-661. At least one of these articles suggests that acrylate based two lens systems are susceptible to ILO formation. [0008] In view of the above, it would be quite desirable to provide an intraocular lens, particularly a two lens system, that inhibits the formation of ILO that might otherwise occur. SUMMARY OF THE INVENTION [0009] In one embodiment, the present invention is directed to an intraocular lens for use as part of a set of dual optic intraocular lenses or piggyback intraocular lenses. The lens includes a body formed of a hydrophobic material and the body defines an outer surface. A coating is disposed on a region of the outer surface of the body. The coating is formed of a hydrophilic material or a super-hydrophobic material. The body and coating cooperatively form a first intraocular lens, which is configured to face and oppose an outer surface of a second intraocular lens when both the first and the second intraocular lens have been implanted within an eye. [0010] In another embodiment, the present invention is directed to an intraocular lens system of dual optic intraocular lenses or piggyback intraocular lenses. The system includes a first intraocular lens having a body defining an outer surface and a coating disposed on a region of the outer surface of the body. The body of the first intraocular lens is formed of a hydrophobic material and the coating of the first intraocular lens is formed of a hydrophilic material or a super-hydrophobic material. The system also includes a second intraocular lens having a body defining an outer surface. The second intraocular lens is disposed adjacent the first lens thereby forming an interlenticular space between the first lens and the second lens. The coating of the first intraocular lens faces and opposes the outer surface of the second intraocular lens. Further, the coating of the first intraocular lens is located directly adjacent and at least partially defines the interlenticular space. [0011] In yet another embodiment, the present invention is directed to a method of producing and/or implanting an intraocular lens system of dual optic intraocular lenses or piggyback intraocular lenses. According to the method, there is provided a first intraocular lens having a body defining an outer surface and a coating disposed upon a region of the outer surface. The body is formed of a hydrophobic material and the coating is formed of a hydrophilic material or a super-hydrophobic material. The first intraocular lens is implanted in an eye such that the first intraocular lens is disposed adjacent a second intraocular lens within the eye. The second lens also has a body defining an outer surface. The first and second lenses cooperatively form the intraocular lens system and the first and second lenses define an intralenticular space between the first and second lens. The coating of the first intraocular lens faces and opposes the outer surface of the second intraocular lens. Moreover, the coating of the first intraocular lens is located directly adjacent and at least partially defines the interlenticular space. The second lens may also have a coating formed of a hydrophilic or super-hydrophobic material and the coating of the second lens will typically face and opposed the coating of the first lens. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a sectional view of a pair of exemplary intraocular lenses that are arranged to form an intraocular lens system in accordance with an aspect of the present invention. [0013] FIG. 2 is a sectional view of a pair of exemplary intraocular lenses are arranged to form an alternative intraocular lens system in accordance with an aspect of the present invention. [0014] FIG. 3 is a front view of an exemplary intraocular lens in accordance with an aspect of the present invention. [0015] FIG. 4 is a sectional view of an exemplary piggyback lens system in accordance with the present invention. [0016] FIG. 5 is a sectional view of an exemplary dual optic accommodative lens system in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION [0017] The present invention is predicated upon the provision of at least one intraocular lens (IOL) and preferably two IOLs that have a coating for aiding in the prevention of opacification, particularly interlenticular lens opacification (ILO). The IOL[s] typically form an intraocular lens system such as a dual optic or piggyback lens system. The coating is typically formed of a hydrophilic or super-hydrophobic material for aiding in the resistance or prevention of ILO. [0018] Unless otherwise specifically stated, percentages of materials as used herein are weight percentages (w/w). [0019] FIG. 1 illustrates an exemplary intraocular lens system 10 in accordance with an aspect of the present invention. The system 10 includes a first intraocular lens 12 and a second intraocular lens 14 . As used herein, the terms “first” and “second” as they are used to indicate a lens of the system are merely used to indicate one of the lenses as opposed to the other. These terms are not intended to suggest any order such as order of implantation, unless otherwise specifically stated. [0020] Each of the lenses 12 , 14 includes a body 18 defining an outer surface 20 and a coating 24 disposed upon a region 28 of that outer surface 20 . The coatings 24 of the lenses 12 , 14 can aid in the prevention of ILO as is discussed further below. Each of the lenses 12 , 14 also includes haptics 32 extending outwardly from the bodies 18 of the lenses 12 , 14 . [0021] Each coating 24 of each of the lenses 12 , 14 faces and opposes the outer surface 20 of the other of the lenses 12 , 14 . This is particularly the case after both lenses have been implanted within an eye. The intraocular lenses 12 , 14 define an interlenticular space 36 therebetween and the coatings 24 of the lenses 12 , 14 are both located directly adjacent and at least partially define the interlenticular space 36 . [0022] In the embodiment shown in FIG. 1 , each of the lenses 12 , 14 has its own coating 24 . However, it is contemplated that only one of the lenses may have a coating while the other lens may be uncoated. This configuration is shown in FIG. 2 . This may be the case, for example, when the intraocular system includes a set of piggyback lenses for which a first uncoated lens has already been implanted and a second coated lens is implanted as an adjustment to the first lens. [0023] In the embodiment of FIG. 1 , the coating 24 of each lens 12 , 14 is disposed upon a region 28 of the body 18 and more particularly is disposed only upon one of two opposing sides 40 , 42 of the body 18 . It is contemplated, however, that the coating may be disposed upon other regions of the body or the entirety of the body of the lens. The term “region” as used herein is intended to mean only a portion of the body. However, the suggestion that the coating covers or is disposed upon a region of the outer surface of the body is not intended to restrict the coating from being located on other portions of the body unless it is specifically stated that the coating is only disposed upon that region. [0024] In instances where the coating is selectively disposed upon only a region of the IOL, it is generally preferred that the region be a substantial portion of the outer surface of the body of the IOL. Preferably, that substantial portion is at least 20%, more preferably at least 40% and even possibly at least 60% of the outer surface of the body. The substantial portion is typically less than 90% and more typically less than 80% of the outer surface of the body. The aforementioned percentages are taken as percentages of total surface area of the body. The outer surface of the body is considered exclusive of any outer surface area of the haptics. Of course, the haptics may also be coated, but are not considered part of the body. [0025] In one preferred embodiment, the coating is formed as a ring about only a peripheral region of the IOL body as shown in FIG. 3 . In such an embodiment, the peripheral region may be on only one side of the IOL or on both sides. It is contemplated that a second IOL in a system according to the present invention could have a ring shaped coating that is configured to oppose and face the ring shaped coating of FIG. 3 or such second IOL may have an alternative coating shape such as a coating covering one entire side of its body. [0026] The body, the haptics or both of any of the intraocular lenses according to the present invention are preferably formed of a hydrophobic material. Such hydrophobic material will typically have a contact angle that is no greater than 90 degrees, more typically no greater than 85 degrees and even possibly no greater than 80 degrees. Such material will also typically have a contact angle that is at least 50 degrees and more typically at least 60 degrees and even possibly at least 65 degrees. Unless stated otherwise, contact angles for the materials of the present invention are determined in accordance with Young's equation as discussed in Physical Chemistry of Surfaces ( sixth edition ), Adamson, Arthur W. et al., Chapter X, pgs. 352-354. [0027] The material of the body, the haptics or both is preferably an acrylate based material. Acrylate based materials are defined as having a substantial portion of acrylate monomers, which are preferably of formulation 1 below: [0000] [0000] wherein: X is H or CH 3 ; m is 0-10; Y is nothing, O, S, or NR wherein R is H, CH 3 , C n H 2n+1 (n=1-10), iso-OC 3 H 7 , C 6 H 5, or CH 2 C 6 H 5 ; Ar is any aromatic ring which can be unsubstituted or substituted with CH 3 , C 2 H 5 , n-C 3 H 7 , iso-C 3 H 7 , OCH 3 , C 6 H 11 , C 6 H 5 , or CH 2 C 6 H 5 ; [0028] Suitable monomers of structure (I) include, but are not limited to: 2-ethylphenoxy methacrylate; 2-ethylphenoxy acrylate; 2-ethylthiophenyl methacrylate; 2-ethylthiophenyl acrylate; 2-ethylaminophenyl methacrylate; 2-ethylaminophenyl acrylate; phenyl methacrylate; phenyl acrylate; benzyl methacrylate; benzyl acrylate; 2-phenylethyl methacrylate; 2-phenylethyl acrylate; 3-phenylpropyl methacrylate; 3-phenylpropyl acrylate; 4-phenylbutyl methacrylate; 4-phenylbutyl acrylate; 4-methylphenyl methacrylate; 4-methylphenyl acrylate; 4-methylbenzyl methacrylate; 4-methylbenzyl acrylate; 2-2-methylphenylethyl methacrylate; 2-2-methylphenylethyl acrylate; 2-3-methylphenylethyl methacrylate; 2-3-methylphenylethyl acrylate; 24-methylphenylethyl methacrylate; 2-4-methylphenylethyl acrylate; 2-(4-propylphenyl)ethyl methacrylate; 2-(4-propylphenyl)ethyl acrylate; 2-(4-(1-methylethyl)phenyl)ethyl methacrylate; 2-(4-(1-methylethyl)phenyl)ethyl acrylate; 2-(4-methoxyphenyl)ethyl methacrylate; 2-(4-methoxyphenyl)ethyl acrylate; 2-(4-cyclohexylphenyl)ethyl methacrylate; 2-(4-cyclohexylphenyl)ethyl acrylate; 2-(2-chlorophenyl)ethyl methacrylate; 2-(2-chlorophenyl)ethyl acrylate; 2-(3-chlorophenyl)ethyl methacrylate; 2-(3-chlorophenyl)ethyl acrylate; 2-(4-chlorophenyl)ethyl methacrylate; 2-(4-chlorophenyl)ethyl acrylate; 2-(4-bromophenyl)ethyl methacrylate; 2-(4-bromophenyl)ethyl acrylate; 2-(3-phenylphenyl)ethyl methacrylate; 2-(3-phenylphenyl)ethyl acrylate; 2-(4-phenylphenyl)ethyl methacrylate; 2-(4-phenylphenyl)ethyl acrylate; 2-(4-benzylphenyl)ethyl methacrylate; and 2-(4-benzylphenyl)ethyl acrylate, and the like. [0029] It is contemplated that the first and second IOLs of a system can be formed of substantially identical material, but may be formed of different materials. Preferably, the material of both IOLs of the system are acrylate based, however, it is possible for one to be acrylate based while another may be formed of a different material (e.g., a silicone based material). In such circumstances, the acrylate based IOL will typically include a coating according to the present invention while the other IOL of different material may or may not include a coating. [0030] The material of the body and/or haptics is typically formed from at least 30%, more typically at least 70% and even possibly at least 95% acrylate monomers. The material of the body and/or haptics is typically formed from no greater than about 99.9% acrylate monomers. These acrylate based materials are typically mixed with a curing agent and/or a polymerization initiator so that the materials may be cured to form the IOLs. As such, it will be understood that these monomers are linked to form polymers in the finished IOLs. Examples of acrylate-based lenses are, without limitation, described in U.S. Pat. Nos. 5,922,821; 6,313,187; 6,353,069; and 6,703,466, all of which are fully incorporated herein by reference for all purposes. [0031] The coating is preferably formed of a hydrophilic material or a super-hydrophobic material. A suitable hydrophilic material will typically have a contact angle that is no greater than 50 degrees, more typically no greater than 45 degrees and even possibly no greater than 35 degrees. Such material will typically have a contact angle that is at least 5 degrees. [0032] A hydrophilic coating can also be formed of a hydrogel material. In such an embodiment, functionalized hydrogel precursors of hydrogel materials such as polyacrylic acid (PAA), polyvinyl acetate (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol (PEG), polyether imide (PEI), combinations thereof or the like may be coated upon the outer surface of the IOL body. The precursors can then be cross-linked by ultraviolet and/or visible light, plasma, radiation, heat energy or the like to form the coating of hydrogel material. [0033] A suitable super-hydrophobic material for the coating will typically have a contact angle that is at least 90 degrees, more typically at least 100 degrees and even more possibly at least 130 degrees. Such material will typically have a contact angle no greater than 177 degrees. [0034] When the coating is formed of a super-hydrophobic material, silicone based materials are typically quite desirable. Silicone based materials are those materials that include a substantial portion of silicon or silicon monomers (e.g., silane or siloxane). When silicone based, the material of the coating typically is formed from at least 30%, more typically at least 60% and even possibly at least 80% silicone monomers. In such embodiment, the material of the coating is typically formed from no greater than about 99.9% silicone monomers. Examples of silicone materials are, without limitation, described in U.S. Pat. Nos. 5,420,213; 5,494,946; 7,033,391; and 7,071,244, all of which are fully incorporated herein by reference for all purposes. [0035] Silicone based coatings can be formed upon the body of the IOL using various techniques. In one embodiment, silicon monomers (e.g., silane or siloxane monomers) can be coated on the outer surface of the body by plasma deposition or polymerization onto the surface of the body. In another embodiment, plasma treatment (e.g., oxygen or water plasma treatment) can be employed to introduce hydroxyl groups onto the outer surface of the IOL body followed by a silanization treatment. In yet another embodiment, a surface modifying agent containing silicone block copolymer can be blended with the acrylate material prior to casting and curing of the IOL. [0036] As an alternative to silicone, super-hydrophobic materials with even greater hydrophobicity (e.g., contact angles of at least 130 degrees) may be used. These super-hydrophobic coatings can be formed using continuous or, more preferably, modulated plasma deposition/polymerization treatment of perfluorocarbons monomers, which can then be cross-linked to form a polytetrafluoroehtylene (PTFE) coating. As an alternative, benzene moieties can be attached to the IOL body outer surface by direct fluorination to form a super-hydrophobic coating. As another alternative, plasma treatment (e.g., oxygen or water plasma treatment) can be used to introduce hydroxyl groups onto the outer surface of the IOL body followed by a fluorinated silanization treatment. [0037] As an alternative or addition to a hydrophilic or super-hydrophobic coating, it is contemplated that a coating may be formed of bioactive agents. As one example, natural or synthetic molecules that modulate or inhibit protein adsorption and/or cell adhesion can be attached to the outer surface of the body to form a modified surface coating (e.g., a modified surface that preferentially adsorb serum albumin). As another example, pharmacological agents such as immunosuppressants, mTOR inhibitors or the like can be attached or otherwise coated on the outer surface of the IOL body to form a coating that prohibits or inhibits lens epithelial cell (LEC) growth. It is also contemplated that a coating may only cover a peripheral region (e.g., a peripheral edge) of the lens body and, for example, may form a ring about the lens body and/or may extend radially outwardly from the peripheral region. Still further, it is contemplated that the coating may be formed as a separate solid film (e.g., an annular disc shape film) that is then disposed over the surface of the lens body and preferably attached (e.g., adhered) thereto. [0038] Implantation [0039] Lens systems of the present invention can be implanted in the eye according various protocols. Typically a first lens is implanted followed by a second lens. It is contemplated, however, that two lenses may be implanted at least partially simultaneously. Both lenses may be implanted in the capsular bag or one may be located in the capsular bag while the other is outside of the capsular bag. [0040] In one preferred embodiment, a first lens is implanted in the capsular bag and then, upon discovery that the first lens is not providing the desired visual performance, a second lens is implanted in the sulces of the eye. Such lenses are typically referred to as piggy-back lenses. As example of such lenses are shown in FIG. 4 . As can be seen, a first lens 50 is disposed in the capsular bag and is without a coating. However, a second lens 52 , which has been implanted later in the sulces does include a coating 54 in accordance with the present invention. Generally, for piggy-back lens systems, the lens implanted in the sulces or the second lens implanted will be the only lens to include a coating since the lens in the capsular bag will have been implanted without the knowledge that a second lens would necessarily be implanted. Of course, it would be possible for the first implanted lens 50 (i.e., the lens in the capsular bag) to also include a coating, particularly if there is a likelihood that a second piggyback lens will be implanted later. In the embodiment shown, the coating 54 is in opposing facing relation to an outer side surface 56 of the first lens 50 and directly adjacent an interlenticular space 58 between the lenses. [0041] In another preferred embodiment, a first lens is implanted in the capsular bag and then a second lens is implanted in the capsular bag and connected to the first lens to form a dual optic intraocular lens system (e.g., an accommodative system). As can be seen in FIG. 5 , a first lens 60 having positive power is implanted and a second lens 62 having negative power is implanted. They are then attached to each other with attachment members 64 (e.g., interlocking haptics or other members) to form a dual optic accommodative intraocular lens system. As can also be seen, both of the lenses 60 and 62 having coatings 66 , 68 on only one side of the lenses 60 , 62 and those coatings 66 , 68 are in opposing facing relation to each other and adjacent an intralenticular space 70 . [0042] The entire contents of all cited references in this disclosure are specifically incorporated herein by reference. Further, when an amount, concentration, or other value or parameter is given as either a range, preferred range, or a list of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. Where a range of numerical values is recited herein, unless otherwise stated, the range is intended to include the endpoints thereof, and all integers and fractions within the range. It is not intended that the scope of the invention be limited to the specific values recited when defining a range. [0043] Other embodiments of the present invention will be apparent to those skilled in the art from consideration of the present specification and practice of the present invention disclosed herein. It is intended that the present specification and examples be considered as exemplary only with a true scope and spirit of the invention being indicated by the following claims and equivalents thereof.

1a

FIELD OF THE INVENTION This invention relates to certain substituted diphenyl ether oxime derivatives and to the use of the same to control the growth of noxious plants, i.e., weeds. DESCRIPTION OF THE INVENTION This invention provides herbicidally active substituted diphenyl ether oxime compounds represented by the Formula I: ##STR1## wherein: X and Y are the same or different halogen; R is hydrogen, halogen, cyano, C 1 to C 4 alkyl or haloalkyl, C 1 to C 4 alkoxy or alkylthio, or mono or dialkylamino; R 1 is hydrogen or C 1 to C 4 alkyl; R 2 is hydrogen or up to C 10 alkyl, haloalkyl, cycloalkyl, alkenyl, alkynyl, alkoxyalkyl or phenyl, substituted phenyl, benzyl or substituted benzyl; and n is 0, 1, 2 or 3. It is, of course, understood that agronomically acceptable salts of the Formula I compounds are within the scope of this invention, e.g., compounds wherein R 2 is an alkali metal ion, ammonium or substituted ammonium ion. Stereo and optical isomers of the Formula I compounds are also included. Suitable alkyl radicals of which the various `R` groups are representative include methyl, ethyl, n-propyl, iso-propyl, n-butyl, t-butyl or iso-butyl. Chloromethyl, chloroethyl, dichloroethyl, bromomethyl, bromoethyl, trifluoromethyl, trifluoroethyl, trichloromethyl and the like are exemplary haloalkyls. As examples of alkoxy and alkylthio radicals there may be mentioned methoxy, ethoxy, propoxy, methylthio, ethylthio or the like. Mono or dialkyl amino groups include methylamino, dimethylamino, methylethylamino, diethylamino or the like. Halogens represented by X and Y include bromine, chlorine or fluorine. Sodium, potassium or lithium, preferably sodium or potassium, are exemplary of alkali metal ions represented by R 2 . Preferred compounds of the Formula I are wherein X and Y are fluorine or chlorine; R is alkyl or haloalkyl; R 1 is hydrogen; R 2 is alkyl or haloalkyl; and n is 0. Compounds of the Formula I may be prepared using techniques known to and starting materials available to the art. For example, a Formula I compound may be prepared by reacting an appropriately substituted diphenyl ether oxime of the Formula II: ##STR2## wherein X, Y, and R are as previously defined, with an appropriately substituted haloalkanoic acid or ester of the Formula III: ##STR3## wherein R 1 , R 2 and n are as previously defined and Hal is halogen, preferably, bromine or chlorine. The following Examples are illustrative of the preparation of a certain compound of this invention. EXAMPLE I Preparation of: 3-(2-chloro-6-fluoro-4-trifluoromethylphenoxy) acetophenone oxime-0-(acetic acid, methyl ester) 7.5 Grams of 3-(2-chloro-6-fluoro-4-trifluoromethylphenoxy) acetophenone oxime was dissolved in 150 milliters of dry tetrahydrofuran and cooled to 0° C. under a nitrogen blanket. 1.2 Grams of sodium hydride were added and the reaction mixture was stirred for 15 minutes. To the stirred reaction mixture were added 3.3 grams of methyl bromoacetate and stirring was continued for one hour, the reaction mixture having warmed to room temperature. The reaction was then poured into 100 milliliters of water and extracted with 150 milliliters of diethylether. After, drying over anhydrous magnesium sulfate, the organic phase was stripped of solvent in vacuo, affording a yellow oil which crystallized on standing. The crystalline solid was twice recrystallized from hexane affording a total of 5.6 grams of recrystallized material confirmed by NMR and MS analyses as the desired product. EXAMPLE II Preparation of: 3-(2,6-dichloro-4-trifluoromethylphenoxy) acetophenone oxime-0-(acetic acid, methyl ester) To 10 milliliters of dimethyl sulfoxide were added, under a nitrogen blanket, 1.39 grams of 3-(2,6-dichloro-4-trifluoromethylphenoxy) acetophenone oxime and 0.66 gram of potassium carbonate. To the stirred reaction mixture was added 0.57 gram of methyl bromoacetate and stirring was continued for 24 hours at room temperature. The reaction mixture was then poured into water and extracted with diethyl ether. The organic phase was then stripped of solvent in vacuo, affording a yellow oil. The oil was charged to a column containing 30 grams of silica gel and eluted with a 1:9 v/v mixture of ethyl acetate:hexane. Solvent removal afforded 0.65 gram of white solid, confirmed by NMR and MS analyses, as the desired product. EXAMPLE III Preparation of: 3-(2,6-difluoro-4-trifluoromethylphenoxy) acetophenone oxime-0-(acetic acid, methyl ester) 1.5 Grams of 3-(2,6-difluoro-4-trifluoromethylphenoxy) acetophenone oxime was dissolved in 20 milliliters of dry tetrahydrofuran and cooled to 0° C. under a nitrogen blanket. 0.25 Gram of sodium hydride was added, followed in 5 minutes by the addition of 0.67 gram of methyl bromoacetate. The reaction mixture was stirred for one hour by which time it had warmed to room temperature. The reaction mixture was then added to water and extracted with 100 milliliters of diethyl ether. The organic phase was dried over anhydrous magnesium sulfate and stripped of solvent, in vacuo, affording a yellow oil which was purified by passage through a column containing 30 grams of silica gel and eluted with hexane followed by diethyl ether. Solvent removal afforded 1.0 gram of colorless, sticky oil confirmed by NMR and MS analyses as the desired product. Although preparation of certain compounds of the invention have been illustrated by the foregoing Examples, it is to be understood that other compounds of the invention may be readily prepared by those skilled in the art using the same or similar techniques and by varying the choice of starting materials. Weed control in accordance with this invention is effected by application, either before or after emergence of weeds, of a herbicidally effective amount of a compound of this invention. It is, of course, to be understood that the term "a compound of this invention" also includes mixtures of such compounds. The term "herbicidally effective amount" is that amount of a compound of this invention required to so injure or damage weeds such that the weeds are incapable of recovering following application. The quantity of a compound of this invention applied in order to exhibit a satisfactory herbicidal effect may vary over a wide range and depends on a variety of factors, such as, for example, hardiness of a particular weed species, extent of weed infestation, climatic conditions, soil conditions, method of application, and the like. Typically, less than one pound per acre of a compound of this invention would be expected to provide satisfactory weed control, although in some instances application rates in excess of one pound per acre; e.g., up to 5 or more pounds per acre might be required. Of course, the efficacy of a particular compound against a particular weed species may readily be determined by routine laboratory or field testing in a manner well known to the art. It is expected that satisfactory weed control can be had at a rate of application in the range of 0.5 to 2.0 pounds per acre. Of course, a compound of this invention can be formulated according to routine methods with any of several known and commonly used herbicidal diluents, adjuvants and carriers. The formulations can contain liquid carriers and adjuvants such as organic solvents, as well as emulsifiers, stabilizers, dispersants, suspending agents, spreaders, penetrants, wetting agents and the like. Typical carriers utilized in dry formulations include clay, talc, diatomaceous earth, silica and the like. Preferred formulations are those in the form of wettable powders, flowables, dispersible granulates or aqueous emulsifiable concentrates which can be diluted with water at the site of application. Also, dry formulations such as granules, dusts, and the like, may be used. When desired, a compound of this invention can be applied in combination with other herbicidal agents in an effort to achieve even broader vegetative control. Typical herbicides which can be conveniently combined with Formula I compound include atrazine, hexazinone, metribuzin, ametryn, cyanazine, cyprazine, prometon, prometryn, propazine, simazine, terbutryn, propham, alachlor, acifluorfen, bentazon, metolachlor and N,N-dialkyl thiocarbamates such as EPTC, butylate or vernolate. These, as well as other herbicides described, for example, in the Herbicide Handbook of the Weed Society of America, may be used in combination with a compound or compounds of the invention. Typically such formulations will contain from about 5 to about 95 percent by weight of a compound of this invention. The herbicidal formulations contemplated herein can be applied by any of several methods known to the art. Generally, the formulation will be surface applied as an aqueous spray. Such application can be carried out by conventional ground equipment, or if desired, the sprays can be aerially applied. Soil incorporation of such surface applied herbicides is accomplished by natural leaching, and is, of course, facilitated by natural rainfall and melting snow. If desired, however, the herbicides can be incorporated into the soil by conventional tillage means. The compounds prepared as described in the Examples were tested for herbicidal efficacy, against a variety of broadleaf weed species, under controlled laboratory conditions of light, humidity and temperature. A solvent solution of said compound was applied postemergence to test flats containing the various weed species, and herbicidal efficacy was determined by periodic visual inspection, after application of the compounds. Herbicidal efficacy was determined on a Numerical Injury Rating scale of from 0 (no injury) to 10 (all plants dead). A NIR of 7 to 9 indicates severe injury; a NIR of 4 to 6 indicates moderate injury, i.e. plant growth is reduced to the extent that normal growth would be expected only under ideal conditions; and a NIR of 1 to 3 indicates slight injury. The following table gives the postemergence NIR for the compounds prepared as described in the Examples against each of the broadleaf weed species to which it was applied. The compound was applied at a rate of 1.0 pound per acre and the NIR was determined two weeks after application. The broadleaf (BL) weeds used in the test were coffeeweed (COFE), jimsonweed (JMWD), tall morningglory (MNGY), teaweed (TEAW), velvetleaf (VTLF), sicklepod (SKPD) and lambsquarter (LMBQ). ______________________________________ ExampleBL-Weeds: I II III______________________________________COFE 9 4 6JMWD 10 10 10MNGY 10 10 10TEAW 6 4 5VTLF 10 5 5SKPD 2 2 1LMBQ 10 10 10Average BL NIR 8.1 6.4 6.7______________________________________ Basis these screening tests, compounds of this invention can be effectively used for postemergence control of a wide variety of broadleaf weeds. Although the invention has been described in considerable detail by the foregoing, it is to be understood that many variations may be made therein by those skilled in the art without departing from the spirit and scope thereof as defined by the appended claims.

1a

BACKGROUND OF THE INVENTION The invention relates to a device for the manufacture of tablets or compacts in accordance with at least two compacting tools which, in each case, can be moved in relation to one another and at least one template interacting with these and with filling means to feed the tabletting material into the template. Automatic devices for the manufacture of tablets are based on the principle that a tabletting material is pressed to a tablet by means of a compacting process. For this purpose, two moving punches serve as compacting tools. Known automatic devices for the manufacture of tablets possess a bottom punch in vertical alignment which works in a template and a top punch which is led into the template only for compacting. The top punch slides into the template, pushes the powder together and compacts the tablet. The thickness, firmness and compacted gloss of the tablet depend on said top punch and its compacting pressure. The depth of insertion and the amount of pressure can be adjusted. The bottom punch is located in the template. It limits the pot towards the bottom. During the compacting process it as a rule forms the pressure sustaining part. At the end of compacting, it is led upwards and so moves the tablet to the template edge where it is pushed to the side. In the next cycle, the bottom punch returns to its start position and the template pot is ready to accept the next filling. The filling of the template is performed via a filling funnel whose bottom part is termed a filling shoe. These known devices are as a rule today designed as concentric tabletting machines. In these types, the filling shoe of the filling funnel is stationary while the template is movable. A round horizontal plate supports a number of templates. As described above, each template has its own top and bottom punch. The punches are raised or lowered via rollers. By turning a horizontal plate, the templates are moved one with their punches after the other into the position ready for filling underneath the filling shoe. Concentric tabletting machines possess a number of serious defects due to their process technology which cannot be eliminated completely due to the design principle of the device described above. Here, the following disadvantages are of most significance in the manufacture of tablets for pharmaceutical purposes or also of compacts in the food sector: An intensive pre-treatment of the substances to be compacted is necessary in order to obtain good flow behavior and dosing capability. The filling principle (fixed filling shoe on a rotating template table) means that relatively high material loss has to be accepted and that, for example, metal rubbings enter into the product to be made through the seal rails to be provided on the filling shoe. The so-called black spots are created on the table surface. Dust created in the compacting pot of the device is first deposited on the free surfaces of the greased top punch. As the process continues, it falls off and enters into the filling shoe through the template table. This effect also leads to the already mentioned "black spots" on the tablet surface. SUMMARY OF THE INVENTION It is therefore the object of the invention to provide a device for the manufacture of tablets or compacts with which tablets or compacts can be manufactured without the so-called "black spots" on the tablet surface. This object is solved on the basis of a device of the type specified in accordance with compacting tools movable in relation to one another being aligned horizontally. In accordance with this, the basic idea to solve the invention is in contrast to the whole prior art to align the compacting tools which can be moved relative to each other no longer vertically, but horizontally. In this way, the occurrence of the "black spots" can be effectively avoided. Perferably, the compacting tools are positioned on a rotor which can be set into rotary motion. Here, multiple compacting tool pairs which pair parts are movable in relation to each other can be arranged at equal distances on the circumference of the rotor. The filling means can be coupled with the rotor in such a way that it can be set into rotary motion together with the rotor. Here, the rotor and filling means can be coupled to each other via the axle of rotation. The filling means can comprise a filling funnel formed in a convex design onto which tapering channels are set in a funnel design the tapered ends of which channels open into a filling aperture of the relevant template. This arrangement of the filling funnel allows the templates to be filled with the tabletting material by means of centrifugal force. In this way, even poorly flowing materials can be processed well and a more precise dosing is possible. Advantageously, the compacting tools which are movable in relation to each other are moved in a horizontal direction during their rotation through guide curves associated with each of them. In this way, at certain angle positions a correspondingly associated work cycle can be performed. A pressure roller can be supported eccentrically to the axis of rotation of the rotor and at the end of the rotating part of the device, two further pressure rollers can be located so that via the eccentric pressure roller and the two further pressure rollers the pressing tools which are positioned between them during the corresponding passage can be pressed against one another. These two further pressure rollers can be located at a different distance to the associated compacting tools in such a way that a compacting pressure with different force can be generated. In this way, at a certain angle position, pre-compacting can be ensured by a first pressure roller and at a second angle position, full compacting can be performed by the second pressure roller. BRIEF DESCRIPTION OF THE DRAWINGS Further details and advantages of the invention are described in more detail by means of an embodiment shown in the drawings in which FIG. 1 shows a schematic section through one part of a first embodiment of the device in accordance with the invention; FIG. 2 illustrates a top view of a part of the device in accordance with the invention in accordance with FIG. 1; and FIGS. 3-5 illustrate detailed representations which explain different worksteps of the device in accordance with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS The device shown in FIGS. 1 and 2 possesses a rotor 1 driven by a motor not shown in any detail here which rotor can be set into rotary motion in rotating direction a in accordance with FIG. 2. On this rotor, in horizontal alignment, are fitted two compacting tools 2, 4 which in each case are movable in relation to one another. The compacting tools 2, 4 are designed in the form of an inner punch 4 and an outer punch 2 which dip into a corresponding borehole of a template 3. On the circumference of the rotor 1 in the present embodiment, are located four compacting tool pairs which interact with the corresponding templates. On a central axle A of the rotor 1 there is additionally positioned a material filling funnel 5 which rotates together with the rotor 1. As the rotor I rotates, the outer compacting tool 2, the outer punch, is moved over an outer guide curve 12 (FIG. 2) in a horizontal plane relative to the rotor 1. Equally, the second compacting tool 4, the inner punch, is moved over a guide curve 11 in the horizontal plane of the rotor as the rotor 1 rotates. In this way, the compacting tools 2 and 4 take on a different position to one another in dependence on the angle position of the rotor 1 due to the corresponding guide curves. This is made clear by means of the representation in accordance with FIG. 2. In position I, the two compacting tools are at a large distance from one another. Here, the tabletting material is filled in and dosed. In position II, the compacting tools 2 and 4 are moved closer to one another. Here the tabletting material is increasingly compressed. To apply the required compacting force, two pressure rollers 6 and 8 are positioned opposite each other here. In this position, the pre-compacting of the tablet or compact is performed within template 3. In position III, the compacting tools 2 and 4 are moved even closer together so that the tabletting material is compressed even further. Here the final compacting pressure to form the tablet is achieved. The final compacting pressure is applied by the pressure roller 6 and the pressure roller 7 (FIG. 2). Finally, the compacting tools are moved by the curve control in such a way that the finished tablet or compact is ejected from the template. This ejection position is marked by IV in FIG. 2. The pressure rollers 6, 7 and 8 are designed to be movable. The pressure roller 6 positioned in the central area of the rotor 1 is located eccentrically to the axle A of the rotor 1 here and is adjustable in its eccentricity. The pressure rollers 7 and 8 are each adjustable in their distance to the rotor 1. Thanks to this adjustability, the compacting forces to form the tablet or compact can be varied. Basically, the pressure rollers 6, 7 and 8 serve, as described above, to generate the required compacting forces and to transfer these to the compacting tools. In this process, at each passage of the compacting tool pair 2, 4 between the pressure rollers 6 and 8 and 6 and 7 associated therewith in each case, a packing of the template contents takes place. The filling means 5 in the embodiment shown here is designed as a filling funnel with a convex design, with the funnel shape being obtained by a cone located in the interior of the filling funnel. Funnel-like tapering channels 9 are formed between the filling funnel 5 and corresponding filling apertures 10 in the templates 3. Due to the centrifugal forces which apply to the tabletting material particles located in the tapering ends as a result of the rotation of the filling funnel, a safe transport and so filling of the templates 3 is ensured at position I. In FIGS. 3 to 5, different working positions of the compacting tools 2 and 4 in relation to each other are shown in each case. In FIG. 3, the phase of template filling is shown. This representation corresponds to position I in FIG. 2. In FIG. 4, the compression of the tabletting material is shown. This phase 2 corresponds to positions II and III of FIG. 2. Finally, FIG. 5 shows the ejecting of the finished tablet T. Phase 3 corresponds to position IV in FIG. 2. It becomes clear here that the finished Tablet T can fall down due to gravity through a corresponding slot 13 into a collecting box not shown in any detail here.

1a

This application is a continuation of application Ser. No. 08/523,417, filed on Sep. 5, 1995, now abandoned, which in turn is a continuation of application Ser. No. 08/236,667, filed on May 2, 1994, now U.S. Pat. No. 5,495,974, which in turn is a continuation of application Ser. No. 07/989,197, filed on Dec. 11, 1992, now abandoned. BACKGROUND OF THE INVENTION The present invention relates to a new and novel fastener attaching tool particularly suited for use in consumer applications such as to recouple detached buttons to clothing, etc. The conventional method of coupling or recoupling buttons to garments or fabrics, either by machine or by hand, is with thread. The button is held in place and a needle containing thread is inserted through each of two, three or more holes in the button and into the material several times until sufficient strands of thread exist to securely hold the button to the material. The thread must then be tied or otherwise fastened so that it will not unravel. In some instances, where it is desired to elevate the button from the material, a pedestal effect is achieved by laterally wrapping the strands with additional thread. The disadvantages to this method of securing buttons to fabric or garments are several. First of all, it is a slow and tedious job and the button can soon become detached if only one of the threads is severed or if the ends of the thread are not secured properly. In the commonly assigned U.S. Pat. Nos. 3,399,432, 3,470,834, and 3,494,004, all of which are incorporated herein by reference, there is described a plastic fastener which may be used instead of thread to couple or to recouple a button to an article of clothing. The fastener typically comprises a flexible filament having a head at one end and a transverse bar at the opposite end. A plurality of such fasteners are typically manufactured as part of a clip in which the fasteners are interconnected in a row to a stringer or runner bar connected to the transverse bars of the fasteners by corresponding necks or connector posts. To sever an individual fastener from the fastener clip and to attach the severed fastener to a desired article (e.g., through a button hole and into an article of clothing), a fastener attaching device is typically used. Such a device typically comprises a casing, a needle projecting from the casing, the needle and the casing having longitudinal bores in alignment with each other, a plunger slidable back and forth within said bores, a handle telescoping over the rear of the casing for sliding said plunger within said bores, and means comprising an indexing wheel for feeding fasteners into the device successively with the transverse bars in alignment with said bores ahead of the plunger so that they may be projected through the needle by reciprocating the plunger. Typically, the rear end of the needle is shaped to define a knife edge so that insertion of the transverse bar into the longitudinal bore of the needle using the plunger causes the knife edge of the needle to sever the connector post connecting the fastener to the remainder of the fastener clip. While the above-described fasteners have been found to be generally satisfactory for attaching buttons to certain articles of clothing, they have not found universal application for the following reasons: First, when placed in direct contact with a person's skin, the transverse bar of the fastener has a tendency to be irritating. This is in part because the above-described severing of the connector post often leaves a burr on the bottom of the transverse bar and is in part because of the somewhat sharp ends and large size of the transverse bar. Second, the fasteners are often too big to be used with many buttons and, therefore, require the use of specially designed buttons having large holes. Third, the fasteners tend to be conspicuous in appearance due to the fact that a separate fastener is used for every button hole, as opposed to being looped between two or more button holes in the same way that thread typically is. SUMMARY OF THE INVENTION It is an object of the present invention to provide a new and novel fastener attaching tool particularly suited for use in consumer applications such as to recouple detached buttons to clothing, etc. It is another object of the present invention to provide a fastener attaching tool as described above which is adapted for use with a new and novel fastener clip, the fastener clip preferably comprising a pair of generally parallel runner bars and one or more fasteners, each fastener comprising a U-shaped filament and a pair of generally parallel transverse bars disposed at opposite ends thereof, the U-shaped filament being disposed in the plane of the pair of generally parallel runner bars and aligned with the longitudinal axes thereof, each of the pair of transverse bars being connected to a corresponding runner bar by a connector post, the connector posts being severably connected to the outer sides of their respective transverse bars. It is still another object of the present invention to provide a fastener attaching tool as described above which lends itself to construction using moldable parts and thus may be mass-produced relatively inexpensively. Additional objects, features, and advantages of the present invention will be set forth in part in the description which follows, and in part will be obvious from the description or may be learned by practice of the invention. The objects, features and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. In a preferred embodiment of the invention, the fastener attaching tool comprises a body, a needle block, a pair of needles, a spring, and an ejector mechanism. Each of the pair of needles includes a longitudinally extending slotted bore adapted to receive one of the transverse bars of the fastener, with the adjacent end of the filament extending through the slot in the bore. The needles are mounted in a parallel arrangement in the needle block which, in turn, is removably mounted in a cavity formed in the front end of the body. Each needle has a knife edge formed on its outer side which is adapted to sever a connector post from its associated transverse bar as the transverse bar is pushed by it. The body is also shaped to include a transverse feed slot disposed just to the rear of the needles down through which the above-described fastener clip is manually inserted. To assist in properly aligning the fastener clip within the feed slot so that the transverse bars of a desired fastener are aligned with the longitudinal bores of the needles, the inner walls of the slot are shaped to include a pair of feed bars which engage corresponding indentations formed on the outer sides of the fastener clip. The ejector mechanism, which is slidably mounted back and forth within the body and is rearwardly biased by the spring, is manually operable from the rear of the body. Actuation of the ejector mechanism is preferably achieved using one's thumb, and the body is provided with a pair of finger openings so that the device may be held and used like a syringe. The ejector mechanism includes a pair of ejector rods which are slidable back and forth within the longitudinal bores of the needles and are used both to load the transverse bars of the aligned fastener into the longitudinal bores of the needles and to push the transverse bars therethrough into a desired article. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are hereby incorporated in and constitute a part of this specification, illustrate the preferred embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings, wherein like reference numerals represent like parts: FIG. 1 is a front view of one embodiment of a fastener clip constructed according to the teachings of the present invention; FIG. 2 is a bottom view of the fastener clip shown in FIG. 1; FIG. 3 is an enlarged front perspective view of one of the fasteners shown in FIG. 1 after it has been separated from the remainder of the fastener clip; FIG. 4 is a top view of one embodiment of a fastener attaching device constructed according to the teachings of the present invention for attaching an individual fastener from the fastener clip of FIG. 1 to a garment through a pair of button holes in such a way as to attach the button to the garment; FIG. 5 is a partially exploded top view of the fastener attaching device shown in FIG. 4 with the body being broken away in part; FIG. 6 is a section view of the body shown in FIG. 5 taken along line 6 — 6 . FIGS. 7 ( a ) through 7 ( d ) are front, rear, top and right side views, respectively, of the needle block shown in FIG. 5; FIG. 8 is a section view of the body shown in FIG. 5 taken along line 8 — 8 ; FIGS. 9 ( a ) through 9 ( d ) are top, right side, left side and rear views, respectively, of one of the needles shown in FIG. 5; FIGS. 10 ( a ) and 10 ( b ) are bottom and right side views, respectively, of the ejector mechanism shown in FIG. 5; FIG. 11 is a top view, broken away in part, of a second embodiment of a fastener attaching device constructed according to the teachings of the present invention for attaching an individual fastener from the fastener clip of FIG. 1 to a garment through a pair of button holes in such a way as to attach the button to the garment; FIG. 12 is an enlarged section view of the front end of the fastener attaching device of FIG. 4 shown with the pair of ejector rods in an advanced position to illustrate how one of the fasteners shown in FIG. 1 may be inserted through a pair of button holes and secured to a garment; FIG. 13 is an enlarged section view similar to FIG. 12 but after the fastener attaching device has been removed showing how one of the fasteners shown in FIG. 1 is used to attach a button to a garment; FIG. 14 is a top view of the combination of the button, garment and fastener shown in FIG. 13; FIG. 15 is a fragmentary front view of a second embodiment of a fastener clip constucted according to the teachings of the present invention; FIG. 16 is a left side view of the fastener clip shown in FIG. 15; and FIG. 17 is a top view of the fastener clip shown in FIG. 15 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring to the drawings and in particular to FIGS. 1 and 2, there are shown front and bottom views, respectively, of a fastener clip constructed according to the teachings of the present invention, the fastener clip being represented generally by reference numeral 11 . Clip 11 is a unitary structure preferably molded from polyurethane or similar materials. Clip 11 comprises five identical fasteners 13 , the number of fasteners being illustrative only. Each fastener 13 includes a flexible U-shaped filament 15 and a pair of transverse bars or feet 17 - 1 and 17 - 2 disposed at opposite ends thereof. To maximize the strength of the fastener, filament 15 is preferably rectangular in cross-section and has a non-uniform thickness, i.e., the arcuate region 16 has a thickness t 1 greater than the thickness t 2 at the ends. Feet 17 - 1 and 17 - 2 are appropriately dimensioned so that they may be inserted into a desired garment through a pair of button holes of conventional size and thereafter be retained by the underside of the garment. Clip 11 also comprises a pair of runner bars 19 - 1 and 19 - 2 , the top ends of which are joined to form a handle 21 . The outer edges of runner bars 19 - 1 and 19 - 2 are provided with indentations 24 which, as will be seen below, assist in properly feeding clip 11 into a fastener attaching tool. Each fastener 13 is connected to runner bars 19 - 1 and 19 - 2 by severable connector posts 23 - 1 and 23 - 2 , respectively. For reasons to be discussed below, connector posts 23 - 1 and 23 - 2 are connected to the outer sides 25 - 1 and 25 - 2 of feet 17 - 1 and 17 - 2 , respectively. In order that fastener 13 may be used with garments in which feet 17 - 1 and 17 - 2 may be placed in direct contact with a person's skin, fastener clip 11 includes the following features which are designed to minimize irritation of a person's skin. First, as noted above, connector posts 23 - 1 and 23 - 2 are connected to the outer sides 25 - 1 and 25 - 2 of feet 17 - 1 and 17 - 2 . In this manner, when posts 23 - 1 and 23 - 2 are severed, burrs 27 - 1 and 27 - 2 (see FIG. 3) are left on outer sides 25 - 1 and 25 - 2 , where they are not as likely to come into contact with a person's skin as they would be if they were left on the bottom surface of feet 17 - 1 and 17 - 2 . Second, feet 17 - 1 and 17 - 2 have a length l which is comparatively small, i.e., approximately 2 mm as compared to 6 mm for the transverse bars of existing like fasteners, and an overall size that is comparable to that of a knot of a thread used to secure a button to a piece of fabric. Consequently, feet 17 - 1 and 17 - 2 have relatively little surface area which may come into contact with a person's skin. Third, the top surfaces 29 - 1 and 29 - 2 of feet 17 - 1 and 17 - 2 , respectively, are generally flat to give feet 17 - 1 and 17 - 2 a low profile and to keep feet 17 - 1 and 17 - 2 from rocking relative to the underside of a garment to which fastener 13 has been attached (see FIG. 13 ). Fourth, feet 17 - 1 and 17 - 2 have rounded ends 31 - 1 / 31 - 2 and 33 - 1 / 33 - 2 , respectively. To use fastener 13 to couple a button to a garment, an individual fastener 13 is first detached from fastener clip 11 by severing connector posts 23 - 1 and 23 - 2 . Feet 17 - 1 and 17 - 2 of the severed fastener 13 are then inserted first through a corresponding pair of button holes and then through the desired garment. Both the severing and inserting steps may be done manually or with the aid of an appropriate fastener attaching tool. Referring now to FIGS. 4 and 5, there is shown one embodiment of a fastener attaching tool suitable for use with fastener clip 11 in the above-described manner, the fastener attaching tool being represented generally by reference numeral 51 . Tool 51 includes a body 53 , a needle block 55 , a pair of needles 57 - 1 and 57 - 2 , a spring 59 , and an ejector mechanism 61 . Body 53 is a unitary structure preferably molded from a lightweight durable plastic. Body 53 is shaped to define a pair of transverse openings 63 - 1 and 63 - 2 which are provided so that a user may operate tool 51 like a syringe by placing the index and middle fingers through openings 63 - 1 and 63 - 2 while actuating ejector mechanism 61 with the thumb. Body 53 is also provided with a transversely extending feed slot 64 down through which fastener clip 11 may be inserted in a direction perpendicular to the longitudinal axis of body 53 . As can be seen best in FIG. 6, slot 64 is shaped to include a pair of feed bars 64 - 1 and 64 - 2 which, as will be discussed below in greater detail, are used to engage indentations 24 on runner bars 19 - 1 and 19 - 2 , respectively, to properly align fastener clip 11 within tool 51 . Needle block 55 , which is removably mounted in a cavity 65 formed in body 53 and accessible from the front end thereof, is shown in greater detail in FIGS. 7 ( a ) through 7 ( d ). As can be seen therein, block 55 is generally rectangular unitary structure having a pair of generally cylindrically shaped grooves 67 - 1 and 67 - 2 adapted to receive needles 57 - 1 and 57 - 2 , respectively. Block 55 is retained within opening 65 by means of a plurality of outwardly biasing tabs 69 - 1 through 69 - 3 which snap into place in corresponding slots 71 - 1 through 71 - 3 (see FIG. 8) in cavity 65 . Block 55 is also preferably molded from a lightweight durable plastic. Needle 57 - 1 , which is a mirror image of needle 57 - 2 reflected along its longitudinal axis, is shown in greater detail in FIGS. 9 ( a ) through 9 ( d ). As can be seen therein, needle 57 - 1 is a unitary structure shaped to include a generally cylindrical slotted bore 73 - 1 . Bore 73 - 1 has a cross-sectional diameter slightly larger than that of foot 17 - 1 of fastener 13 . The forward end 75 - 1 of needle 57 - 1 is pointed to permit its insertion through garments and button holes of conventional size. The rearward end 77 - 1 of needle 57 - 1 is open and is appropriately dimensioned to permit foot 17 - 1 to be loaded into bore 73 - 1 with the adjacent end of filament 15 extending through the slot of bore 73 - 1 . Needle 57 - 1 is retained within groove 67 - 1 of block 55 by means of a downwardly-angled fin 79 - 1 which engages a corresponding slot 81 - 1 in groove 67 - 1 (see FIGS. 7 ( b ) and 7 ( c )). The left side of needle 57 - 1 (viewing needle 57 - 1 from its rearward end 77 - 1 as opposed to its forward end 75 - 1 ) is shaped to define a knife 83 - 1 . As will be described below in greater detail, knife 83 - 1 is used to sever the connecting post 23 - 1 connecting a desired fastener 13 to runner bar 19 - 1 . (A corresponding knife edge formed on the right side of needle 57 - 2 is similarly used to sever the connecting post 23 - 2 connecting the same fastener to runner bar 19 - 2 .) Needles 57 - 1 and 57 - 2 are preferably cut and stamped from sheet metal. Ejector mechanism 61 , which is shown in greater detail in FIGS. 10 ( a ) and 10 ( b ), is slidably mounted within a longitudinally extending channel 89 formed in body 53 and accessible from the rear end thereof. As can be seen therein, mechanism 61 comprises an elongated generally rectangular ejector block 91 having a front portion 91 - 1 of comparatively smaller cross-section and a rear portion 91 - 2 of comparatively larger cross-section. A pair of ejector rods 93 - 1 and 93 - 2 are fixedly mounted on the forward end of front portion 91 - 1 . As will hereinafter be described in greater detail, ejector rods 93 - 1 and 93 - 2 are appropriately dimensioned and properly positioned so that, as ejector block 91 moves through channel 89 , the front ends of ejector rods 93 - 1 and 93 - 2 cause feet 17 - 1 and 17 - 2 of a fastener 13 which is properly disposed within slot 64 to be loaded onto needles 57 - 1 and 57 - 2 and thereafter to be ejected therefrom. A disc-shaped base 95 is fixedly mounted on the rearward end of rear portion 91 - 2 to facilitate manipulation of mechanism 61 . Ejector rods 93 - 1 and 93 - 2 are preferably made of metal, and the remainder of ejector mechanism 61 is preferably molded from lightweight durable plastic. Lightweight movement of mechanism 61 within channel 89 is restricted by base 95 and by a pair of integrally formed posts 97 - 1 and 97 - 2 disposed on the top and bottom surfaces, respectively, of rear portion 91 - 2 which travel in corresponding guide slots 99 - 1 and 99 - 2 (see FIG. 5) formed in body 53 . Posts 97 - 1 and 97 - 2 are made to be depressable inwardly to permit insertion of block 91 into channel 89 . Spring 59 , which engages the front of channel 89 at one end and the forward end of rear portion 91 - 2 at the opposite end, biases ejector mechanism 61 towards the rear of channel 89 . A fastener dispensing tool similar in construction to tool 51 is shown in FIG. 11, the tool being represented generally by reference numeral 101 . The differences between tool 101 and tool 51 are few, the principal differences being the shape of body 103 , the lack of a base 95 in tool 101 , and the construction of spring 105 . Tool 101 is operated in the same way as tool 51 . In use, a desired fastener clip 11 is loaded into tool 51 by grasping handle 21 and pushing the clip down through inlet 106 slot 64 until the indentations 24 on runner bars 19 - 1 and 19 - 2 corresponding to a desired fastener 13 are engaged by bars 64 - 1 and 64 - 2 . With this done, feet 17 - 1 and 17 - 2 of the desired fastener 13 are positioned behind needles 57 - 1 and 57 - 2 , respectively, and are in alignment with their corresponding bores 73 - 1 and 73 - 2 . To attach a button to a piece of fabric using the fastener loaded in the above manner, the tips 75 - 1 and 75 - 2 of needles 57 - 1 and 57 - 2 , respectively, are inserted first through a pair of holes in the button and then through the piece of fabric. Ejector mechanism 61 is then advanced through channel 89 towards the front of body 53 . The initial advancement of ejector mechanism 61 causes ejector rods 93 - 1 and 93 - 2 to push feet 17 - 1 and 17 - 2 of the desired fastener 13 into bores 73 - 1 and 73 - 2 . As the advancement of ejector mechanism 61 continues, ejector rods 93 - 1 and 93 - 2 push feet 17 - 1 and 17 - 2 past knife edges 83 - 1 and 83 - 2 of needles 57 - 1 and 57 - 2 , causing connector posts 23 - 1 and 23 - 2 to be severed thereby. Finally, as the advancement of ejector mechanism 61 terminates, ejector rods 93 - 1 and 93 - 2 cause feet 17 - 1 and 17 - 2 to be ejected from the front ends of needles 57 - 1 and 57 - 2 . Ejector mechanism 61 is then allowed to retract and needles 57 - 1 and 57 - 2 are withdrawn. FIG. 12 shows a fastener 13 being inserted through a pair of button holes 8 1 and 8 2 and into a piece of fabric F using tool 51 . Referring now to FIGS. 13 and 14, there are shown section and top views, respectively, of a button 8 which has been coupled to a piece of fabric F using fastener 13 . As seen best in FIG. 13, the advantages resulting from gating fastener 13 to runner bars 19 - 1 and 19 - 2 on the outer sides of feet 17 - 1 and 17 - 2 are substantial as burrs 27 - 1 and 27 - 2 are not left on the bottoms of feet 17 - 1 and 17 - 2 where they are most likely to irritate a person's skin. The consequences of making the top surfaces of feet 17 - 1 and 17 - 2 flat, as opposed to curved, to give feet 17 - 1 and 17 - 2 a low profile and to keep feet 17 - 1 and 17 - 2 from rocking in the directions indicated by arrows C and D can also be seen in FIG. 13 . As seen best in FIG. 14, another benefit to fastener 13 is that, by having filament 15 extend between button holes 8 1 and 8 2 in a looped fashion, it creates the appearance that thread, as opposed to a plastic fastener, is being used to secure the button to the fabric. Referring now to FIGS. 15 through 17, there are shown various views of a second embodiment of a fastener clip constructed according to the teachings of the present invention, the fastener clip being represented generally by reference numeral 131 . Fastener clip 131 includes a plurality of identical fasteners 133 , each fastener 133 including a flexible filament 134 having a head 135 at one end and a foot 137 at the opposite end. Foot 137 is similar in size and shape to feet 17 - 1 and 17 - 2 of fastener 13 . Fastener clip 131 also includes a runner bar 141 which is severably connected to fasteners 133 by connector posts 143 , each connector post 143 being connected to the side of its corresponding foot 137 . The embodiments of the present invention recited herein are intended to be merely exemplary and those skilled in the art will be able to make numerous variations and modifications to it without departing from the spirit of the present invention. All such variations and modifications are intended to be within the scope of the present invention as defined by the claims appended hereto.

1a

This is a continuation of application Ser. No. 170,620 filed July 12, 1980 abandoned. BACKGROUND OF THE INVENTION The present invention relates to apparatus for peeling vegetables and more particularly to apparatus for slicing peel from vegetables using a cutting knife. Industrial apparatus for peeling vegetables commonly employs abrasive or chemical means. The abrasive means can include abrasive rotating discs or drums which abrade the surface to remove the vegetable peel. The chemical means include immersion of the vegetable in a caustic liquid which dissolves the outer layer including the peel. The caustic liquid and dissolved vegetable are washed away with water. For certain users, it is desirable to produce a peeled vegetable having a smooth shiny outer surface such as is produced by manual peeling with a knife. This is especially true in the preparation of carrot sticks for sale and consumption in fresh uncooked form. Unfortunately, both of the above-mentioned industrial peeling methods leave a dull looking and/or abraded outer surface. OBJECTS AND SUMMARY OF THE INVENTION It is an object of the present invention to provide a vegetable peeling apparatus which overcomes the drawbacks of prior devices. It is a further object of the invention to provide an industrial vegetable peeling apparatus which removes the vegetable peel with cutting knives. According to an aspect of the invention, there is provided a vegetable peeling apparatus comprising at least first and second pairs of parallel knife members and means fur urging the knife members of each pair toward each other. Means are also provided for forcing a vegetable to be peeled successively between each of the pairs of parallel knife members. The pairs of parallel knife members have means responsive to the forcing of the vegetable between them for moving the parallel knife members apart to accommodate the vegetable therebetween. Each knife member includes means for slicing a strip of peel from the vegetable as it is forced therebetween whereby first and second strips of peel are sliced from opposed sides of the vegetable. The pairs of prallel knife members are angularly offset from each other so that each pair of knife members slices first and second strip of peel from different surface portions of the vegetable. The above, and other objects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings in which like reference numerals designate the same elements. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a simplified perspective view of an embodiment of the invention from which certain elements are omitted for clarity of presentation. FIG. 2 shows an end view of one of the cutting knife assemblies of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to FIG. 1, parts of a peeling apparatus are shown with other parts ommitted for clarity of presentation. A plurality, preferably four, pairs of cutting knife assemblies, represented by two cutting knife assemblies 10 and 12, in FIG. 1 are stacked for sequential operation on a vegetable or other item to be peeled. Each of the four cutting knife assemblies is identical to cutting knife assembly 10 except for its position in the stack and its angular orientation, and therefore only cutting knife assembly 10 is described in detail. Cutting knife assembly 10 includes a first knife member 14 opposed to a second knife member 14'. First knife member 14 has an outwardly flaring guide plate 18 to provide an entry portion. A pair of support bars 20 and 22 extend downward near the ends of guide plate 18 leaving a space 24 therebetween. A knife bar 26 is supported near the ends of support bars 20 and 22. A pair of pivot pins 28 and 30 are welded or otherwise affixed to support bars 20 and 22 respectively. A pivoted arm 32 is pivoted to a machine frame, represented in FIG. 1 by a bar 34 by any convenient means such as by a bolt 36 and a nut 38. A U-shaped saddle 40 is rigidly affixed to the outboard end of pivoted arm 32. Arms 42 and 44 of U-shaped saddle 40 include pivot holes 46 and 48 therein through which pivot pins 28 and 30 are passed. It should be clear that first knife member 14 is pivotable about an axis defined by pivot pins 28 and 30. Referring now also to the end view of cutting knife assembly 10, in FIG. 2, a stop member 50 is rigidly affixed to U-shaped saddle 40 outside the central area in which cutting normally takes place. Stop member 50 has an upper abutment 52 which is effective to contact the inner surface of guide plate 18 to limit the couterclockwise rotation of first knife member 14 in FIG. 2. Stop member 50 also has a lower abutment 54 which is effective to contact knife bar 26 to limit the clockwise rotation of knife member 14 in FIG. 2. The total angular freedom of first knife member 14 is preferably between about 15 and 25 degrees and is most preferably about 20 degrees. Second knife member 14' is an identical mirror image of first knife member 14. Thus, elements of second knife member 14' are identified by primed reference numbers and will not be further described. A resilient member of any convenient type such as a coil spring 56 urges pivoted arms 32 and 32' and knife members 14 and 14' toward each other. Instead of being pivoted to bar 34 at separate bolts 36 and 36', pivoted arms 32 and 32' may be curved or bent in a fashion well known in the art and not shown to permit pivoting, both of pivoted arms 32 and 32' on a single pivot. Furthermore, it would be clear to one skilled in the art that, as pivoted arms 32 and 32' are moved apart, knife bars 26 and 26' develop a skew angle between them rather than remaining parallel. A pantograph arrangement may be substituted for pivoted arms 32 and 32' to maintain knife bars 26 and 26' parallel at all values of separation therebetween. Cutting knife assembly 12 is seen to have its axis rotated approximately 45 degrees with respect to the axis of cutting knife assembly 12, and have its knife bars 26" and 26"' disposed directly above knife bars 26 and 26' of cutting knife assembly 14. Two additional cutting knife assemblies (not shown) are preferably included in the apparatus. A first of the additional cutting knife assemblies should have its axis rotated an additional 45 degrees from that of cutting knife assembly 12. This places its axis 90 degrees from the axis of cutting knife assembly 10. The other of the additional cutting knife assemblies should have its axis rotated an additional 45 degrees from that of cutting knife assembly 12. This places its axis 90 degrees from the axis of cutting knife assembly 10. The other of the additional cutting knife assemblies should have its axis rotated 90 degrees from that of cutting knife assembly 12 (135 degrees from cutting knife assembly 10). A pusher assembly 58, may be employed to push a vegetable or other object, such as a carrot 60 through the sets of cutting knife assemblies. Carrot 60 may be suitable prepared by cutting off the top and bottom thereof in a conventional manner before peeling. Pusher assembly 58 may use any suitable technology capable of providing the required motion, but preferably employs a pneumatic or hydraulic cylinder 62 which is operative to expel and withdraw a plunger 64 the required distance and at the required speed to propel carrot 60 completely through the four cutting knife assemblies at production speeds. Although not shown in FIG. 1, plunger 64 may have a plurality of tines on the outer extremity thereof for piercing carrot 60 to secure it thereto and to prevent carrot 60 from rotating as it passes through the four cutting knife assemblies. In operation, a carrot 60 or other suitable object to be peels is pushed end first by plunger 64 toward the uppermost cutting knife assembly 12. Before the arrival of carrot 60, guide plates 18" and 18"', as well as knife bars 26" and 26"' are closer together than the diameter of carrot 60. Carrot 60 pushes against the angled portions of guided plates 18" and 18"' to thereby increase the opening between knife bars 26" and 26"' to a value which just permits carrot 60 to pass therebetween. Upper abutments 52" and 52"' (FIG. 2) prevent excessive rotation of knife members 14" and 14"'. As carrot 60 is forced into contact with the cutting edge of knife bars 26" and 26"', thin peel slices 66 and 68 are removed from opposite sides of carrot 60. Knife members 14" and 14"' pivot about their respective pivot pins (not shown) as required to conform to the angle of carrot 60 and to local surface irregularities thereon. A similar peeling operation takes place in passage of carrot 60 through the remaining three cutting knife assemblies including cutting knife assembly 10. A completely peeled carrot 60 is seen below cutting knife assembly 10. The completely peeled carrot has eight flat sides corresponding to the eight knife bars which have removed strips of peel therefrom. Having described a specific embodiment of the invention with reference to the accompanying drawings, it is to be understood that the invention is not limited to this precise embodiment, and that various changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims. For example, more or less than the preferred four cutting knife assemblies may be employed for removing pairs of peel slices. Two cutting knife assemblies appears to be a minimum. Furthermore, instead of having two opposed knife bars, each cutting knife assembly may have three or more knife bars without departing from the invention. Auxiliary apparatus, such as guides and water spray devices may also be employed.

1a

BACKGROUND [0001] Computer games and other types of simulations typically include a virtual universe that users interact with in order to achieve one or more goals, such as shooting all of the “bad” guys or playing a hole of golf. A virtual universe is the paradigm with which the user interacts when playing a computer game and can include representations of virtual environments, equipment, objects, characters, and associated state information. For instance, a virtual universe can include a virtual golf course, golf clubs and golf balls. Users interact with a virtual universe through a user interface that can accept input from a game controller (e.g., a joy stick, a mouse, verbal commands). A click of a mouse button, for example, might cause a virtual golf club to swing and strike a virtual golf ball in the virtual golf course. [0002] Typical computer game genres include role-playing, first person shooter, third person shooter, sports, racing, fighting, action, strategy, and simulation. A computer game can incorporate a combination of two or more genres. Examples of popular computer games include, Black & White 2 (available from EA Games), Grand Theft Auto (available from Rockstar Games), Perfect Dark Zero (available from Microsoft Game Studios), and Halo 3 (available from Microsoft Game Studios). Computer games are commonly available for different computer platforms such as workstations, personal computers, game consoles 104 (e.g., Sony PlayStation and PlayStation Portable, Microsoft Xbox, Nintendo GameCube and Game Boy), cellular telephones 102 , and other mobile computing devices. See FIG. 1 . Computer games can be single player or multi-player. Some multiplayer games allow users connected via the Internet to interact in a common or shared virtual universe. [0003] Users interact with one or more pieces of virtual equipment in a virtual universe, such as a virtual weapon or a virtual golf club. Virtual equipment can also include avatars and other virtual representations of a user including, but not limited to, a user's movements and gestures. By way of illustration, fighting games allow a user to box, kick or punch virtual opponents in a virtual universe. The virtual equipment in these cases is the virtual representation of the user (or the user's movements or gestures) in the fight. [0004] The virtual universe and virtual equipment can change as users achieve goals. For example, in action games as users advance to higher game levels, typically the virtual universe is changed to model the new level and users are furnished with different virtual equipment, such as more powerful weapons. Some computer games allow users to manually select their virtual equipment. For example, a user interface 106 ( FIG. 1 ) for a computer golf game allows users to choose which type of virtual golf club they will use. Users having little skill may chose a fairway wood club 108 rather than a driver 10 , which is harder to control in the virtual universe (as in real life). However, computer games do not automatically adapt a given piece of virtual equipment to accommodate how skilled a user has become at using that virtual equipment. SUMMARY [0005] In general, in one aspect, embodiments of the invention feature determining a user skill level for user interaction with virtual equipment in an interactive computer game. The virtual equipment is capable of being manipulated through user interaction with an associated representation. A virtual equipment model associated with the virtual equipment is automatically adapted to reflect the determined user skill level. The virtual equipment model governs how the virtual equipment behaves in response to user interaction with the representation. [0006] These and other embodiments can optionally include one or more of the following features. The adapting includes changing a sweet spot for the virtual equipment. The sweet spot is an area of a distribution curve for a variable associated with the virtual equipment model. The sweet spot is related to one or more of: accuracy of the user interaction and precision of the user interaction. The adapting includes changing an input model or the associated representation. The adapting is based on a current state of a virtual universe. The determining is in response to detecting an improvement or a decline in the user skill level. The representation includes one or more of: graphical rendering, sound, or haptic feedback. The adapting includes changing or more relationships between a plurality variables in the user interaction model. The virtual equipment is one of: a golf club, a weapon, an automobile, a racket, a ping pong paddle, or a baseball bat. [0007] In general, in another aspect, embodiments of the invention feature determining a user skill level for user interaction with virtual equipment in an interactive computer game. The virtual equipment is capable of being manipulated through user interaction with an associated representation. A sweet spot associated with the virtual equipment is automatically adapted based on the determined user skill level, the sweet spot governing how the virtual equipment behaves in response to user interaction with the representation. [0008] These and other embodiments can optionally include one or more of the following features. The sweet spot is an area of a distribution curve for a variable associated with the virtual equipment. The sweet spot is related to one or more of: accuracy of the user interaction and precision of the user interaction. The adapting includes changing an input model or the associated representation. [0009] Particular embodiments of the invention can be implemented to realize one or more of the following advantages. Virtual equipment automatically adapts to reflect changes in user skill level and keep users challenged as their skill level improves. As a result, users are less likely to loose interest in a computer game. An associated user input model and visual representation of virtual equipment can be automatically modified to reflect changes in users' skill levels. Automatically adapting virtual equipment adds a dimension of realism to electronic games of skill and other types of simulations and provides a more accurate reflection of skill in a virtue world, less hindered by a static, limited user interface. [0010] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, aspects, and advantages of the invention will become apparent from the description, the drawings, and the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 illustrates a user interface for selecting a golf club. [0012] FIG. 2 illustrates four exemplary graphs related to equipment control. [0013] FIG. 3 illustrates a virtual equipment model system. [0014] FIG. 4 illustrates a virtual equipment model adaptation process. [0015] FIG. 5 illustrates a system architecture. [0016] Like reference numbers and designations in the various drawings indicate like elements. DETAILED DESCRIPTION [0017] In various implementations, a given piece of virtual equipment has one or more associated “sweet spots”. A sweet spot translates into a margin of error that a user's interaction with a piece of virtual equipment will cause an intended outcome in a virtual universe. In one implementation, a large sweet spot corresponds to a greater deviation on a normalized distribution curve and a small sweet spot corresponds to a lesser deviation on a normalized distribution curve. [0018] For example, there are different types of golf clubs for golfers of differing abilities, each golf club having various sized and located sweet spots. Generally speaking, a golfer can select a club based on the golfer's swing speed and power, and based on the golf club's sweet spot. A club with a large sweet spot tends to be very forgiving since the club's face has been designed with a large surface area in which to make contact with the ball and has a perimeter weigh distribution to balance a miss hit. A golfer's swing of a club with a large sweet spot can be several standard deviations from the mean—the mean being a perfect swing—and still result in an acceptable shot. However, in having a large sweet spot the golfer usually forgoes some level of control, power and feel. For a professional golf club, the sweet spot is much smaller and requires a greater amount of skill to correctly hit the ball but the rewards for hitting a proper shot usually result in farther distance, control, precision, and accuracy. A golfer's swing of a club with a small sweet spot must be closer to the mean in order to be an acceptable shot. [0019] In real life, as users become more skilled with equipment, their existing equipment is easier to use and they can select new equipment that gives them an increased level of control. This observation forms the basis for automatically adjusting a piece of virtual equipment's sweet spot(s) according to a user's skill level. Graph 202 in FIG. 2 illustrates standard deviation curves 202 b , 202 c , 202 d for variables associated with the same or different pieces of virtual equipment. For example, curve 202 b could represent the power of a virtual golf club swing, curve 202 c could represent the orientation of the virtual golf club face when it impacts a virtual golf ball, and curve 202 d could represent the trajectory of a kick or a punch for a virtual fighter. A zero deviation represents the ideal value of a variable (e.g., a small sweet spot) for a piece of virtual equipment, such as the ideal power of a virtual golf club swing or the ideal aim of a virtual gun. Each standard deviation away from zero represents increasingly less than ideal values for a given variable. In one implementation, values above a threshold 202 a (which can be different for each curve) have a higher probability of causing a successful outcome (e.g., achieving a goal such as landing a virtual golf ball where the user intended) than values below the threshold. The sweet spot can be viewed as the area of a distribution curve above the threshold and within the requisite standard deviation from the mean. For instance, even with a large sweet spot, it may still be possible to cause a successful outcome if the value for a given variable is above the threshold, although the outcome may not be ideal. Moreover, sweet spots can be varied by the type of virtual equipment. For example, curve 202 b could represent a professional forged golf iron club with a very small sweet spot (e.g., +/−1 standard deviation) and curve 202 c could represent a hollow back off set beginner iron club with a much larger sweet spot (e.g., +/−1.8 standard deviation). [0020] As a user becomes more adept at using a piece of virtual equipment, the sweet spot for one or more of the virtual equipment's variables is adjusted to require the user's interaction with the virtual equipment to achieve values for those variables closer to their means in order to cause a successful outcome. Likewise, as a user's skill level decreases, the sweet spot for one or more of the virtual equipment's variables can be adjusted to allow the user's interaction with the virtual equipment to achieve values for those variables farther from their means and still have a chance of causing a successful outcome. [0021] Accuracy is the probability that a given piece of virtual equipment will perform as a user intended. The probability that a swing of a virtual golf club will cause a virtual golf ball to follow an intended trajectory and land where it was aimed is an example of accuracy. By way of another illustration, accuracy can be the probability that a virtual gun will hit a virtual target when fired. Precision is the probability that user interaction with a given piece of virtual equipment will result in the same outcome time after time. For example, precision can be the probability that the same swing of a golf club will result in the same outcome. In one implementation, the accuracy and precision of a given piece of virtual equipment can be automatically increased as a user's skill level increases. Similarly, the accuracy and precision of a given piece of virtual equipment can be automatically decreased as a user's skill level decreases. These relationships are illustrated in exemplary graphs 204 and 206 of FIG. 2 . In summary, a user's ability to control virtual equipment increases commensurate with their skill level as shown in graph 208 . Although the exemplary graphs 204 , 206 and 208 in FIG. 2 illustrate roughly linear relationships, other relationships are possible and can be defined by a virtual equipment model, as described below. [0022] FIG. 3 is a diagram of a virtual equipment model (VEM) system 300 for a computer game application or other simulation. The functionality encompassed in system 300 can be distributed to fewer or more components than those illustrated. The system 300 includes a VEM 306 which models a piece of virtual equipment. A piece of virtual equipment may comprise more than one object in the virtual universe, such as a set of virtual balls that are juggled by the user in a computer juggling game. In one implementation, there is a VEM 306 for each piece of virtual equipment a user may interact with in a virtual universe. In a further implementation, the VEM 306 maintains a nonempty set of variables and a nonempty set of relationships among two or more of the variables for modeling the behavior of the piece of virtual equipment. In one implementation, a sweet spot for a piece of virtual equipment is inversely related to the precision and accuracy of the virtual equipment. [0023] In one implementation, the VEM 306 minimally includes variables, as described above, representing precision, accuracy, one or more distribution curves (e.g., 202 b , 202 c ), thresholds (e.g., 202 a ), and sweet spots. If the virtual equipment is a golf club, for instance, variables can include stroke power, club face trajectory, distribution curves and associated sweet spots and thresholds for stroke power and club face trajectory, club accuracy, and club precision. [0024] Generally speaking, a VEM 306 variable's value can be based on a user input, a user's skill level at using the virtual equipment, the attribute of the virtual equipment itself, the state of the virtual universe (e.g., weather, emotional and physical stresses on the player) as determined by a game engine 310 , configuration information, the value of one or more other variables, and combinations of these. An input model 302 maps user inputs (e.g., button presses, voice commands, sounds, gestures, eye movements, body movements, brain waves, other types of physiological sensors, and combinations of these) to one or more variable values for variables in the set of variables associated for VEM 306 . The VEM 306 interprets user input provided by the input model 302 using the set of relationships. The VEM 306 has an associated representation 304 of the virtual equipment that is presented to a user, such as through a graphical display means (e.g., a liquid crystal or plasma display device), sound generation means, haptic technology, odor generation means, and combinations of these. For example, in a first person shooter game a virtual gun can have a graphical representation consisting of cross hairs indicating where the gun is currently pointed and sound feedback to indicate when the virtual gun is fired. A joystick or other user input device can be used to aim the virtual gun and a button can be pressed to fire the virtual gun. The VEM 306 communicates with a game engine 310 to affect changes to the virtual universe based on user interaction with the VEM 306 . [0025] The set of variables, their values, and relationships associated with the VEM 306 can change based the state of a virtual universe, or the context or purpose for which a piece of virtual equipment is used. For example, if the virtual equipment is a sword in a sword fight computer game, successful use of the sword requires a user to perform certain offensive and defensive actions that are appropriate given the actions of the user's opponent. In addition to sweet spot(s) associated with the virtual sword, each virtual sword action may have its own sweet spot(s) associated with it, which can change based on the type of offensive or defensive action the user is attempting. The sword's sweets spot could also vary based on the type of sword being used which would also affect the threshold level. [0026] A skill level monitor 306 monitors changes to user skill level. A change in user skill level can be detected by the user's proficiency at using a given piece of virtual equipment to achieve one or more goals in the virtual universe (e.g., such as an improved score), the ability to perform relatively advanced tasks with the virtual equipment, an achieved accuracy rate using the virtual equipment, an achieved precision rate using the virtual equipment, time spent using the virtual equipment, combinations of these, and other factors. In one implementation, user skill level is quantified as a number. If the skill level increases or decreases beyond a certain threshold, a change is communicated to the VEM 306 , which in turn can communicate the change to the input model 302 and the representation 304 . Using a non-zero threshold value can prevent the VEM 306 from changing too rapidly. [0027] Based on a change in skill level, one or more of the VEM 306 , the input model 302 , and the representation 304 can adapt to reflect the change. Adapting the VEM 306 can include changing the value of one or more variables in the set of variables, changing one or more relationships in the set of relationships, adding or removing one or more variables in the set of variables, adding or removing one or more relationships in the set of relationships, and combinations of these. In the case of an increased user skill level, for example, the virtual equipment model 306 could add additional variables for controlling the virtual equipment that were not available at a lower skill level and change variables representing distribution curves, thresholds and sweet spots. [0028] Adapting the input model 302 can include changing the way a user interacts with the representation 304 by adding or removing required and optional user inputs, changing the order of user inputs, changing the semantics of user input, and changing the mappings of user input to one or more variables in the set of VEM 306 variables. By way of illustration, if the virtual equipment is a golf club, the user input at one skill level could include two mouse button clicks: the first click to set the power of a stroke and the second click within a preset time limit from the first click to determine the trajectory of the golf club face as strikes a virtual golf ball. User input at a more advanced skill level could add a third mouse click to determine the loft of the virtual golf ball. Adapting the representation 304 can include changing the virtual equipment appearance, the user interface, sound, haptics, odors, or combinations of these. For example, if the input model 302 or the VEM 306 has been adapted, the representation can be modified to provide an indication of such to the user. A virtual golf club's appearance could be changed to indicate that a user is playing with a more advanced club, for instance. [0029] A game engine 310 maintains state for the virtual universe based on user input and the interaction of objects in the virtual universe. The game engine 310 can include a renderer for rendering graphical views of the virtual universe that can be presented on a display device. The game engine can also artificial intelligence capabilities for determining one or more future states for the virtual universe. Objects in the virtual universe such as virtual equipment are associated with assets 312 (e.g., content, models, sounds, physics, artificial intelligence). Assets are used by the game engine 310 to represent objects and render the computer game. The game engine 310 communicates with the skill level monitor 308 to convey user skill level information, such as detected changes to user skill level. The VEM 306 communicates with the game engine 310 to affect changes to the virtual universe based on user interaction with the VEM 306 . [0030] FIG. 4 illustrates a virtual equipment model adaptation process. A user skill level for a piece of virtual equipment is determined by, for example, the skill level monitor 308 (step 402 ). It is then determined whether the skill level has increased or decreased beyond a threshold (step 406 ). If the user skill level has not increased or decreased beyond the threshold, the user skill level is determined again at a later point in time (step 402 ). Otherwise, the VEM 306 associated with the virtual equipment is adapted based on the user skill level (step 406 ), for example by changing the value of one or more sweet spots associated with the virtual equipment, or other variables. The input model 302 and representation 304 can be optionally adapted based on the user skill level (step 408 ), for example by depicting the head of a golf club differently to emphasize the golf club's changed properties. [0031] FIG. 5 is a block diagram of exemplary system architecture 500 for automatically adapting virtual equipment model. The architecture 500 includes one or more processors 502 (e.g., IBM PowerPC®, Intel Pentium® 4, etc.), one or more display devices 504 (e.g., CRT, LCD), one or more graphics processing units 506 (e.g., NVIDIA® Quadro FX 4500, GeForce® 7800 GT, etc.), one or more network interfaces 508 (e.g., Ethernet, FireWire, USB, etc.), one or more input devices 510 (e.g., keyboard, mouse, game controller, camera, microphone, etc.), and one or more computer-readable mediums 512 (e.g. SDRAM, optical disks, hard disks, flash memory, L1 or L2 cache, etc.). These components can exchange communications and data via one or more buses 514 (e.g., EISA, PCI, PCI Express, etc.). [0032] The term “computer-readable medium” refers to any medium that participates in providing instructions to a processor 502 for execution, including without limitation, non-volatile media (e.g., optical or magnetic disks), volatile media (e.g., memory) and transmission media. Transmission media includes, without limitation, coaxial cables, copper wire and fiber optics. Transmission media can also take the form of acoustic, light or radio frequency waves. [0033] The computer-readable medium 512 further includes an operating system 516 (e.g., Mac OS®, Windows®, Linux, etc.), a network communication module 518 , computer game assets 520 , and a computer game application 522 . The computer game application 522 further includes a game engine 524 , a skill level monitor 526 , one or more VEMs 528 , one or more input models 530 , and one or more representations 532 . In some implementations, the electronic game application 522 can be integrated with other applications 534 or be configured as a plug-in to other applications 534 . [0034] The operating system 516 can be multi-user, multiprocessing, multitasking, multithreading, real-time and the like. The operating system 516 performs basic tasks, including but not limited to: recognizing input from input devices 510 ; sending output to display devices 504 ; keeping track of files and directories on computer-readable mediums 512 (e.g., memory or a storage device); controlling peripheral devices (e.g., disk drives, printers, GPUs 506 , etc.); and managing traffic on the one or more buses 514 . The network communications module 518 includes various components for establishing and maintaining network connections (e.g., software for implementing communication protocols, such as TCP/IP, HTTP, Ethernet, etc.). The application 522 , together with its components, implements the various tasks and functions, as described with respect to FIGS. 2-4 . [0035] The user system architecture 500 can be implemented in any electronic or computing device capable of hosting the application 502 , or part of the application 502 , including but not limited to: portable or desktop computers, workstations, main frame computers, personal digital assistants, portable game devices, mobile telephones, network servers, etc. All of these component may by physically remote to each other. [0036] Embodiments of the invention and all of the functional operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Embodiments of the invention can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a computer-readable medium for execution by, or to control the operation of, data processing apparatus. [0037] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub-programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network. [0038] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit). [0039] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for performing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio player, a Global Positioning System (GPS) receiver, to name just a few. Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry. [0040] To provide for interaction with a user, embodiments of the invention can be implemented on a computer having a display device, e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, for displaying information to the user and a keyboard and a pointing device, e.g., a mouse or a trackball, by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, brain waves, other physiological input, eye movements, gestures, body movements, or tactile input. [0041] Embodiments of the invention can be implemented in a computing system that includes a back-end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front-end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the invention, or any combination of one or more such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), e.g., the Internet. [0042] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. [0043] While this specification contains many specifics, these should not be construed as limitations on the scope of the invention or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the invention. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a sub combination. [0044] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products. [0045] Thus, particular embodiments of the invention have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results.

1a

FIELD OF THE INVENTION [0001] The present invention relates to a mechanism for use in an article of clothing, wearable fabric or garment. More particularly, the present invention relates to a mechanism adapted to enable a user to electrically connect different electrically powered devices to a wearable fabric or garment. BACKGROUND OF THE INVENTION [0002] Efforts have been made previously to create clothes, fabrics and garments that incorporate electrodes for monitoring a condition of the wearer, such as an Electro-cardiogram, or conductive fibers for electromagnetic screening. U.S. Pat. No. 4,580,572 to Granek et al. discloses a garment for delivering and receiving electric impulses which can include wires sewn onto the cloth or conducting cloth sewn onto non-conducting cloth. [0003] However, although useful, these patents fail to address and combat the inherent problems of utilizing wearable electronics. There exist certain operational problems in wearable electronics. These operational problems include the interface between soft fabrics and hard product. This interface, for instance between a shirt and bulky computer or bulky sensory equipment can lead to uncomfortable results to the wearer of the article of clothing. Attaching a bulky product to the inside of a jacket or shirt can cause discomfort, cuts, burns, bruises and related injury to the wearer. Furthermore, there also exist problems associated with the decreased flexibility of the article of clothing that has a bulky hard product disposed therein. Generally, the comfort, flexibility and fit of an article decrease dramatically when a user adds bulky, heavy and inflexible electronic devices to the garment. [0004] Additionally, there also are operational difficulties with regard to electrical connectivity between the electronic device and a circuit integrated in the article of clothing. Given the wide range of activities that the wearer may engage in, either rain or perspiration may penetrate or otherwise enter the electrical circuit. Fluid, perspiration and moisture may disrupt the operation of the wearable garment hence, the difficulties associated with the implementation in practice. Additionally, protection of the wearer of the garment from the detrimental attributes of an electronic device is a great concern. [0005] A need, therefore, exists for a mechanism for electrically connecting various electronic devices to an article of clothing. There is also a need for an improved mechanism having a sliding track for carrying the various electronic devices, the sliding track having at least one channel, the channel selectively enclosing at least one conductive element disposed therein, the channel enabling selective access to the at least one conductive element. Further, there is a need for an improved mechanism having a sliding track for carrying the various electronic devices attached to an article of clothing that is comfortable, and flexible. Still further, there is also a need for an improved mechanism for electrically connecting an electronic device to a power supply that will not permit perspiration, fluid or moisture to interrupt the electrical connection and that is safe and not maintenance intensive. SUMMARY OF THE INVENTION [0006] There is provided a mechanism for electrically connecting various electronic devices to a garment. The mechanism has a sliding track for engaging and slidably supporting at least one electronic device. The sliding track has one or more channels with at least one conductive element disposed therein. The one or more channels selectively enclose or seal the one or more conductive elements so as to allow for the selective electrical communication between the at least one electronic device and a power source. BRIEF DESCRIPTION OF THE DRAWINGS [0007] Other objects, advantages and features of the present invention will be understood by reference to the following specification in conjunction with the accompanying drawings, in which like reference characters denote like elements of structure and: [0008] [0008]FIG. 1 is a cross sectional view of the mechanism for electrically connecting various electronic devices to an article of clothing of the present invention with the conductors in the open position; [0009] [0009]FIG. 2 is a cross sectional view of the mechanism for electrically connecting various electronic devices to an article of clothing of the present invention with the conductors in the closed position; [0010] [0010]FIG. 3 is a top view of the mechanism for electrically connecting various electronic devices to an article of clothing; [0011] [0011]FIG. 4 is a side view of the mechanism for electrically connecting various electronic devices to an article of clothing; [0012] [0012]FIG. 5 is a cross sectional view of another exemplary embodiment of the mechanism for electrically connecting various electronic devices to an article of clothing; [0013] [0013]FIG. 6 is a top view of the mechanism of FIG. 5; [0014] [0014]FIG. 7 is a cross sectional view of the mechanism along line A-A of FIG. 5. DESCRIPTION OF THE PREFERRED EMBODIMENT [0015] With reference to FIGS. 1 through 7, there is provided a mechanism for electrically connecting various electronic devices to an article of clothing. The mechanism includes a sliding track 10 for carrying various electronic devices, such as for example diagnostic equipment, sensors, mobile computers, cooling devices and mobile telephones. Sliding track 10 is a bulbous member. Sliding track 10 may be stitched, knit, bonded, adhered or affixed via a hook and loop material to an article of clothing. Sliding track 10 has a flat bottom surface that may be disposed adjacent to or attached to a garment. Sliding track 10 may be extruded from a suitable non-conductive material and may be cut or stitched to a garment, such as a shirt, pants, shoes, hat or coat. In an exemplary embodiment of the present invention, sliding track 10 is formed from rubber. The sliding track 10 has a top surface that is disposed on the exterior surface of an exemplary garment. The top or bulbous area of the sliding track 10 has a plurality of channels. In an exemplary embodiment of the present invention, the sliding track 10 may have two lower channels 12 and two upper channels 14 . Lower channels 12 and upper channels 14 may be formed as U shaped apertures cut out or extruded with the sliding track 10 . [0016] In an exemplary embodiment of the present invention, the upper channels 14 and lower channels 12 have curvilinear edges 20 that define slits in the lateral sides of the sliding track 10 . An exemplary feature of the upper channels 14 and the lower channels 12 is that the upper channels 14 and the lower channels 12 encapsulate or otherwise seal and/or insulate at least one first conductive material, such as a copper wire, a metal coated carbon fiber, a metallic fiber, a doped fiber, a conductive fiber, an conductive organic material or a conductive polymer that may be disposed therein. In this manner, the upper channels 14 and the lower channels 12 prevent moisture, perspiration or fluid from entering upper channels 14 and lower channels 12 . [0017] Disposed in the respective upper channels 14 and lower channels 12 is at least one first conductive material forming a lengthwise strip of material 50 . An exemplary feature of the first conductive material 50 , is that first conductive material 50 is disposed along a length of the sliding track 10 in each respective channel. First conductive material 50 may be stitched into the sliding track 10 . In another exemplary aspect, the first conductive material 50 may be any suitable material that may conduct electricity or photons particles. First conductive material 50 may be disposed in any suitable location in upper channels 14 and the lower channels 12 so as to maintain the seal and/or insulation properties of the upper channels 14 and the lower channels 12 . For illustrative purposes, the first conductive material 50 is disposed on the respective lateral side walls of the sliding track 10 parallel to the vertical center axis of the sliding track 10 . Another exemplary feature of the first conductive material 50 is that the first conductive material 50 is electrically connected to a power source, for example a battery pack (not shown). Power source (not shown) may be a portable battery, a DC power source, solar power or any other suitable power supply for supplying electric current to the first conductive material 50 . [0018] In an exemplary embodiment of the present invention, first conductive material 50 is sewn or otherwise disposed in the garment. The first conductive material 50 is disposed in between the respective edges 20 of the U shaped channels in a manner to maintain a seal to prevent perspiration, moisture or any fluid from entering into and contacting the first conductive material 50 throughout the length of the garment. First conductive material 50 is also insulated to protect the wearer of the garment. An aspect of the exemplary insulation is that thermal and electrical conductivity, from the power supply (not shown) to the first conductive material 50 is not transmitted to the user's body tissues. [0019] Referring now again to FIG. 1, there is shown an exemplary attachable portable electronic device 100 that may be affixed to an exemplary garment. Electronic device 100 is illustrated as a rectangular shaped device, however one skilled in the art should appreciate that electronic device 100 may be any suitable shape and size. An exemplary feature of the electronic device 100 is that electronic device 100 has a plurality of spring biased rectangular buttons 105 disposed on the lateral sides of the electronic device 100 . Connected to buttons are a plurality of second conductive elements 110 and 115 . Second conductive elements 110 and 115 are shown as rectangular cylindrical structures, however second conductive elements 110 and 115 may be any suitable shape and size to allow second conductive elements 110 and 115 to mate with the respective upper channels 14 and lower channels 12 . An exemplary feature of the second conductive elements 110 and 115 is that second conductive elements 110 and 115 protrude through the respective edges 20 , insulation and/or seal and interface or otherwise mate with at least one first conductive element 50 to provide electrical power to electronic device 100 . One skilled in the art should appreciate that second conductive elements 110 and 115 are made from any suitable electrically conductive material, such as for example a copper wire, a metal, a conductive polymer, a metal coated carbon fiber, a doped fiber a metallic fiber, a wire, or any combination thereof. A plurality of spring members 120 are disposed along the length of the second conductive elements 110 and 115 . However, any other suitable method for biasing second conductive elements 110 and 115 may be utilized and incorporated into the present invention. [0020] Referring now to FIG. 2, as can be understood from the drawings there is shown the sliding track 10 with electronic device 100 receiving electrical power from the first conductive element 50 . In an exemplary embodiment of the present invention, electronic device 100 has a contact 150 for a connection with ground. Contact 150 is disposed in the interior of electronic device 100 , however it should be appreciated that contact 150 may be disposed in any suitable location in electronic device 100 for grounding electronic device 100 . It should be appreciate by one skilled in the art that a user may depress buttons 105 by imparting an axial force to at least one or both buttons 105 on the exterior surface of electronic device 100 . In this manner, second conductive elements 110 and 115 extend laterally in the direction toward sliding track 10 . One skilled in the art should appreciate that the second conductive elements 110 and 115 protrude through the channel edges 20 , insulation and/or seal and contact or otherwise communicate with the at least one first conductive element 50 . In this manner, the power from mobile power supply (not shown) is directed through first conductive element 50 to the second conductive elements 110 and 115 . [0021] In an illustrative embodiment of the present invention, the second conductive elements 110 and 115 contact and supply electrical power to electronic device 100 to operate electronic device 100 . In an exemplary embodiment of the present invention, the electronic device 100 may be any suitable product 100 that utilizes electric power such as a computing device, a semiconductor, a sensor for monitoring physical aspects of the wearer, a mobile telephone, a mobile information infrastructure or any other suitable portable electronic device that may be attached to a garment and add beneficial qualities to the wearer and user. [0022] Referring to FIG. 3 and FIG. 4, there is provided a respective top view and a cross sectional side view of an exemplary embodiment of the present invention for illustration purposes only. As can be understood from the drawings slider track 10 is stitched to the garment by knit operation 40 . However, any known methods in the art for attaching slider track 10 to a garment may be utilized including for example an adhesive, a hook and loop operation and/or bonding. As can be further understood from FIG. 3, the electronic device 100 has buttons 105 that extend and protrude outward from the exterior lateral sides of electronic device 100 . It should also be appreciated that buttons 105 may be place in any suitable location disposed on electronic device 100 for allowing the second conductive elements 110 and 115 to mate with the respective pair of first channels 14 and second channels 12 . Buttons 105 allow respective pair of second conductive elements 110 and 115 to interface with first conductive element 50 and transfer electrical power from first conductive element 50 to second conductive elements 110 and 115 to electronic device 100 for operational purposes. [0023] It should be also appreciated by one skilled in the art, that electronic device 100 may slide, glide or otherwise traverse vertically up and down the face of the garment in substantially parallel relation to first conductive element 50 , on sliding track 10 without a short circuit or interruption of power. An exemplary aspect of the sliding track 10 is that the sealing and/or insulation of the respective first channels 14 and respective second channels 12 is not disturbed by the sliding movement of the electronic device 100 . Respective first channels 14 and respective second channels 12 are fabricated such that perspiration, fluid or moisture does not at any time enter the respective first channels 14 and respective second channels 12 to interrupt the transfer of power from first conductive material 50 to electronic device 100 . [0024] Referring to FIG. 5, there is provided a cross sectional view of another exemplary embodiment of the present invention. An adapter 310 or intermediate element is provided. Adapter 310 may be formed as a rectangular structure. Disposed on the bottom side of adapter 310 are a number of third conductive elements 320 . A strip 200 may also include a first protective element 300 and a second protective element 305 disposed on the top side of the strip 200 . An exemplary aspect of the first protective element 300 and the second protective element 305 is that the respective first protective element 300 and the second protective element 305 overlay and provide a seal and/or insulation to the first conductive element 50 disposed within the strip 200 . [0025] In an exemplary embodiment of the present invention, a number of third conductive elements 320 are disposed on the bottom side of an adapter 310 . One skilled in the art should appreciate, that any number of third conductive elements 320 may be used to transmit a suitable amount of power through adapter 310 to an exemplary electronic device (not shown). Third conductive elements 320 interface with first conductive element 50 to provide power to an exemplary electronic device (not shown). First conductive element 50 may be disposed in any suitable location in a flexible strip 200 . Strip 200 may be a rectangular shaped thermally non-conductive and electrically non-conductive structure that houses the first conductive element 50 . [0026] An exemplary feature of the first conductive element 50 is that the first conductive element 50 is in spaced relation and adjacent to a first protective element 300 and a second protective element 305 . First protective element 300 and a second protective element 305 mate with one another to act as a seal and insulator. In this manner, the first protective element 300 and the second protective element 305 prevent moisture, perspiration and/or fluid from entering and interrupting the flow of power through the first conductive element 50 disposed in the strip 200 . An exemplary feature of the first protective element 300 and a second protective element 305 is that the respective first protective element 300 and a second protective element 305 are a substantially rectangular in shape. The respective first protective element 300 and a second protective element 305 include a connection point having a male and female member disposed therebetween to allow the respective first protective element 300 and a second protective element 305 to interface with respect to one another. The respective first protective element 300 and a second protective element 305 are selectively attached to strip 200 that houses the first conductive element 50 . The respective first protective element 300 and second protective element 305 extend outward from strip 200 and are of a suitable width to fit within a pair of arcuate channels 120 , 130 that are disposed on adapter 310 . [0027] It should be appreciated by one skilled in the art, that strip 200 may be connected or otherwise stitched to the garment. A number of third conductive elements 320 are electrically connected through adapter 10 by wires to an exemplary socket or interface 205 disposed on the top surface of the adapter 10 . Top surface of the adapter 10 includes an aperture 210 for allowing the respective plurality of second conductive elements (not shown) disposed on an exemplary electronic device to connect with socket 205 so electronic device may receive power when electronic device is disposed on top of adapter 310 . [0028] Referring to FIG. 6, there is provided a top view of the present invention. As can be understood from the drawings, the respective first channel 120 and the second channel 130 are curvilinear in shape. First channel 120 and second channel 130 allow first protective element 300 and a second protective element 305 to spread apart with respect to one another and pass therethrough. In this manner, an exemplary electronic device 100 may transverse strip 200 disposed on garment. As can be further understood from the drawings, an electronic device may be disposed on the socket 210 on the top surface of the adapter 310 . Strip 200 is made from a suitable thermally and electrically non-conductive material. Strip 200 may be attached by a knit operation to an exemplary garment. [0029] Referring to FIG. 7, there is provided a cross sectional view along line AA of the adapter 310 . As can be understood from the drawings, the strip 200 has the respective first protective element 300 and second protective element 305 disposed on the top surface of strip 200 . In this manner, first protective element 300 and second protective element 305 are spread apart. First protective element 300 and second protective element 305 pass through the respective first channel 120 and second channel 130 in the curvilinear fashion as adapter 310 traverses the strip 200 . Along line A-A, the first channel 120 and second channel 130 intersect to form a sole unified channel. After adapter 310 passes over a portion of the strip 200 the curvilinear channels 120 , 130 direct first protective element 300 to mate with second protective element 305 as shown in FIG. 7. The first protective element 300 mates with second protective element 305 as shown in FIG. 7, thereby allowing the strip 200 to seal and encapsulate the respective at least one first conductive element 50 disposed therein. One skilled in the art should appreciate first protective element 300 and second protective element 305 in the closed position as shown in FIG. 7 are suitable to prevent moisture, perspiration and fluid from entering therein so that uninterrupted power may be transferred from a power supply (not shown) to the exemplary electronic device 100 . [0030] The present invention having been thus described with particular reference to the preferred forms thereof, it will be obvious that various changes and modifications may be made therein without departing from the spirit and scope of the present invention as defined in the appended claims.

1a

TECHNICAL FIELD The present invention relates to a probe for physiological tonometry or pressure measurement in a human or animal body, the probe comprising a probe head, a line such as a catheter, and a pressure transducer in the probe head. For measuring pressure in the body, the probe head with the pressure transducer is disposed at the measuring site, with the probe head being adapted to be connected to an analyzer and display unit via the line. BACKGROUND OF THE INVENTION Probes of this kind have been known for a long time and are employed particularly for intra-cranial pressure measurement. There, the probe consists of a probe head including an electric pressure transducer. For tonometric measurement, the probe head with the pressure transducer is arranged on the measuring site. The probe head is then connected via a catheter including electric connecting leads to an analyzer and display unit by means of a coupler such as a connector. The pressure measured by the probe or detected by the pressure transducer included in the probe head is then displayed in the display unit. Such probes may be used mainly to measure the epidural pressure—in this case the probe is located between the cranial bones and the Dura mater—the subdural pressure—here the probe is located between the Dura mater and the brain substance—the parenchymatous pressure—for this measurement the probe is located in the brain substance—or the ventricular pressure—in which case the probe is located in a ventricle. All of these measurements are consistently measurements of a relative pressure, which means that the pressure is measured relative to the environment. The pressure transducer consists, for instance, of a piezo crystal mounted on the distal end of the catheter in the probe head. The catheter may comprise a silicon tube or a tube made of another biologically compatible material, for example, and includes electric leads disposed inside. The catheter is adapted for connection via a coupler to the analyzer and display unit. Resistance strain gauges or capacitive pressure transducers may also be employed as an alternative to the piezo crystal. The electric pressure transducer is designed as a bridge circuit, e.g. in the form of a Wheatstone bridge, in order to increase the sensitivity. A current or voltage source outside the probe is provided for supplying the bridge circuit or the pressure transducer with electric power. The leads are connected to a voltage source and the pressure transducer. For tonometric application, the probe is guided to the measuring site in the body. Then the catheter is connected to the analyzer and display unit that serves equally as power or voltage source, i.e. a source of energy, for the probe. The energy and equally the electric signals are transmitted via the electric leads contained in the catheter tube. The measurement of a relative pressure requires the storage of the electric value of the bridge voltage at zero pressure. To this end, null balancing must be carried out. The crucial point in the known probes resides, however, in the aspect that these probes are only able to perform a certain number of pressure measurements and must then be recalibrated. As a result of the necessary sterilization cycles, the users are therefore required to record a log of the number of the operating applications of the probe. When a predetermined number of operating applications of the probe—i.e. of pressure measurements—is reached, the probe must be returned to the manufacturer for recalibration. This method of recording the performed operating applications is, however, extremely expensive and, as a rule, does not function in an optimum manner in practical application. As result, probe failure occurs again and again because the probes are used even though the specified number of operating applications has been exceeded. In the everyday routine in a hospital it is impossible to keep records of the number of operating applications. The reliability and safety in operation is then no longer ensured and failure occurs in the implanted condition, which exposes the clinically monitored patient to a substantial risk. SUMMARY OF THE INVENTION The present invention is therefore based on the problem of improving a probe for physiological pressure measurement in the human or animal body in such a way that a facilitated recording of the operating applications will become possible while the aforementioned disadvantages are avoided. This problem is solved by providing a counter means which records the number of performed operational applications of the probe. This problem can also be solved by a controller means, which records a transducer offset value after each autoclaving or sterilization operation performed to sterilize the probe after each use and detects an error condition by detecting abnormal offset values or abnormal offset value changes since a previous autoclaving or sterilization operation. The invention is based on the finding that counter or controller means are available of such a small size that they can be incorporated into probes so that the probe can record and report its operating applications automatically. In accordance with the present invention, the probe therefore comprises a counter or controller means recording the operating applications of the probe. In this simple manner it is ensured that each tonometric application will be recorded. Now a record kept by hand is no longer required. Moreover, this provision improves the safety with respect to manipulations of the specified number of operating applications and hence the documentability of possibly asserted warranty claims. In a preferred embodiment at least one additional counter for counting overload conditions of the pressure transducer is integrated in the unit. It can be set to count overload conditions all the time during autoclaving or sterilization or only during regular operation. In another preferred embodiment an additional counter for counting autoclaving or sterilization operation is provided. These autoclaving or sterilization operations may be detected by a rise in temperature or pressure. Another preferred embodiment of the invention comprises an additional timer for measuring operational hours. The counter means is preferably disposed in that part of the coupler that is connected to the line. In order to prevent specifically any use of the probe in excess of the specified number of operational uses and hence false measuring results or the failure of the probe during measurement, the counter means renders the pressure transducer and hence the probe inoperative as soon as the specified number of operating applications is reached. The number of the operating applications and/or the number of applications remaining until the end of service of the probe can be displayed via a display means so that the user can inform himself at any time about the remaining number of operational applications and the number of completed operational uses of the probe. To this end, the display means is integrated, in particular, into that part of the coupler that is connected to the line so that the user can obtain this information from the probe directly. According to one embodiment of the invention, the probe comprises an electric pressure transducer and an electric counter means. The counter means is configured with temperature-resistant electric components. The counter means triggers a counting operation only when voltage is applied to the probe throughout a defined period. This provision is intended to prevent that the counting operation is triggered when a voltage is applied only briefly. This may be the case, for instance, when the connection with the probe is to be tested. What is to be counted is only the occurrence of an actual application in operation, i.e. when the voltage is applied, for instance, for half an hour at minimum. To prevent a further use of the probe when the specified number of operating applications has already been reached, the counter means operates a switch that disconnects the power supply of the pressure converter when a specified number of operational applications is reached. The analyzer and display unit recognizes this situation and stops the measurement or no longer permits a further measurement. This prevents a further application of the probe in operation. The user is hence forced in a simple manner to return the probe to the manufacturer for inspection and calibration. The counter means preferably operates in a decrementing mode for rendering the probe inoperative, i.e. it counts from the specified number down to zero so that when zero is reached the probe is taken out of service. Additionally, the counter means operates continuously in an incrementing mode for recording the total number of operational applications of the probe. The user is thus enabled, on the one hand, to detect the total number of applications of the probe and, on the other hand, to establish the number of potential operating applications remaining up to the point where the probe is rendered inoperative and the probe must be inspected and calibrated by the manufacturer. To ensure small dimensions of the probe and to widen the range of potential applications even further, the counter means comprises a microprocessor with a memory, with the number of operating applications as well as the remaining number of potential operating applications up to the end of service being stored in this memory. According to one embodiment of the invention, the display means is constituted by a light-emitting diode that indicates the desired number by a string of flashing signals. With this provision, the smallest display means possible is implemented. Preferably the number of the specified operational applications of the probe can be set. This number is set in particular when the specified number of operating applications is reached, at which the probe is rendered inoperative, and at the time when the service is resumed after calibration. The setting is carried out by means of appropriate software. In order to be able to handle maintenance jobs in a facilitated manner the memory stores further data such as manufacturer-specific information such as serial number, customer number, date of delivery, name of the person calibrating the probe, date of last calibration, or the like. The blood-borne Creutzfeld-Jakob (CFJ) disease has occurred recently to an increasing extent. Insofar it is necessary to use methods for sterilization which operate at temperatures higher than 130° C. in order to ensure a complete and safe destruction of the CFJ agents. The probe therefore consists of a biologically compatible material stable in terms of temperature, which allows a sterilization method such as autoclaving/steam sterilization above 130° C. As far as is known to date, the CFJ agents are completely destroyed at these temperatures, which permits repeated use of the probe. A particular field of application of this probe is that of intra-cranial pressure measurement. For this application a small size—preferably a diameter less than 8 mm is required. With a drop-shaped housing the explantation is simplified significantly. Another preferred embodiment of the invention comprises a controller which detects an error condition by comparing an offset value by at least on predetermined limit value. So the offset value can be compared for example with an upper limit value and a lower limit value. If it is outside the limit values an error condition occurs. For improved detection of error conditions a value like the first order derivation which is a measure of change of offset values is calculated. This may be done by subtracting an offset value of a previous offset value and dividing the difference by a value which is either the number of operational/calibration cycles or the time elapsed between the measurement of these values. An error condition may be detected by comparing such a value by at least on predetermined limit value. By this way extreme, abnormal changes of the offset value can be detected. For further improved detection the previous procedure can be applied to the change of offset values themselves to get a second order derivation. This can also be compared by predetermined limit values. A method for monitoring lifetime and reliability of pressure probes is described. This method uses a probe head, a line such as a catheter, and a pressure transducer in the probe head. The number of operational applications of the probe are counted. A method for monitoring lifetime and reliability of pressure probes is described. This method uses a probe head, a line such as a catheter, and a pressure transducer in the probe head. The offset value of the pressure transducer is measured after each sterilization operation or before each new application of the probe. The offset value, changes of offset values, changes of changes of offset values are evaluated to detect error conditions or states of abnormal operation. BRIEF DESCRIPTION OF THE DRAWINGS Further advantages and features of the invention become evident from the following description of an embodiment of the invention with reference to the drawings wherein: FIG. 1 is a schematic view of the inventive probe including a connecting cable; FIG. 2 shows a schematic illustration of the measurement of cerebral pressure, using the probe of FIG. 1; and FIG. 3 is a block diagram of the counter means of the probe according to FIG. 1 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the drawings reference numeral 30 is alternatively related to the counter or controller. The physical arrangement of counter and controller could be at the same positions although their functions are different. FIG. 1 shows a probe 18 according to the present invention while FIG. 2 is a schematic illustration of a display and analyzer unit 10 for intra-cranial pressure measurement. A connecting cable 12 is connected to this unit 10 and, via a plug connector 14 which serves as coupler, to a catheter 16 . A probe head 20 is disposed on the distal end of the catheter 16 . The probe head 20 is inserted via an opening 24 into a patient's skull 22 . The probe head 20 is located here between the Dura mater and the cranial bones for measuring the epidural pressure. The probe 18 comprises a piezo crystal as pressure transducer, together with a bridge circuit, in a manner known per se. The bridge circuit is supplied with power via leads extending within the catheter 16 , with the unit 10 serving as energy source. A window 26 is formed in the connector 14 to permit an unobstructed view of a light-emitting diode 28 inside the connector 14 . FIG. 3 is a schematic block diagram illustrating components inside the part 14 b of the connector 14 . A counter/controller means 30 , which cooperates with the light-emitting diode 28 and a switch 32 , is connected to the input side of the bridge circuit. The counter/controller means 30 is connected to the energy source of the bridge circuit via line 34 and via line 36 . Alternatively a controller means can be used instead of the counter means. A voltage supplied by the energy source serves to operate a microprocessor 38 that cooperates with a memory 40 . The microprocessor 38 and the memory 40 are parts of the counter means 30 disposed inside the part 14 b of the connector 14 . The counter/controller means 30 comprises moreover data lines 42 and 44 connected to a data input 46 and a data output 48 . A predetermined number is input into the counter/controller means 30 via the data lines, and when this number is reached the switch 32 is actuated. The predetermined number is set by means of a computer. The measuring signals of the bridge circuit are transmitted via the lines 50 and 52 to the unit 10 . Prior to the start of operation of the probe 18 , a predetermined number is input via the data lines 42 and 44 into the counter/controller means 30 , for instance twenty operational applications. Furthermore, a period is specified via the data lines 42 and 44 , from which onwards a respective counting operation is to be performed. For example, when a voltage is applied to the lines 34 and 36 for at least half an hour, a counting operation is triggered. The counter/controller means 30 hence counts the number of operational applications, i.e. the pressure measurements, of the probe 18 . An operational application is then defined in such a way that a voltage must be applied to the lines 34 and 36 for at least half an hour. When the voltage has been applied for more than half an hour a counting operation is triggered. The counting operation then decrements from the specified number one unit at a time, so that the number of remaining operational applications is stored in the memory 40 . Furthermore, the total number of operational applications is detected, which means that after each operational application the number is incremented by one and then separately stored in the memory 40 . The number of operational applications still remaining up to actuation of the switch 32 is indicated by a string of flashing signals via the light-emitting diode 28 . The switch 32 is illustrated in FIG. 3 in a state in which the probe has not yet reached the predetermined number of operational applications. As soon as the specified number of operating applications is reached the switch 32 is closed to short the lines 34 and 36 . With this switching the bridge circuit is rendered inoperative and the probe 18 can no longer be used for tonometric applications. The user must then return the probe 18 to the manufacturer for calibration. After calibration, the manufacturer sets anew the specified number via the setting means 42 and 44 , so that the switch 32 will be opened again and the probe 18 is switched again into its state ready for operation. The counter/controller means 30 moreover comprises a data input 46 and a data output 48 via which the contents of the memory 40 can be read, which means that the manufacturer can establish how often the probe 18 has been in operation altogether and how often calibration has been performed. Apart therefrom, additional data is stored in the memory 40 , specifically the customer number, the serial number, the data of delivery, the name of the person calibrating the probe 18 and the data of calibration, the date of last calibration of the probe, and similar information. The predetermined number of the counter/controller means 30 may be set and the operation of the probe 18 resumed via the data lines 42 and 44 and the data input 46 and the data output 48 , with the switch 32 then resuming its open position illustrated in FIG. 3 . A series resistor 54 is inserted in line 34 —plus—so that the monitor of the display and analyzer unit 10 will not be affected. The probe 18 is made of a temperature-resistant and biologically compatible material and is adapted for complete autoclaving, together with the catheter 16 . The invention ensures in a simple manner that an electric counter/controller means 30 with small dimensions can be realized in the probe 18 , via which the predetermined number of operational applications is indicated. The switch 32 serves to prevent the probe 18 from being operative beyond the specified number of operating applications. List of Reference Numerals 10 analyzer and display unit 12 connecting cable 14 connector 14 a socket 14 b plug 16 catheter 18 probe 19 pressure transducer 20 probe head 22 cranium (skull) 24 cranial opening 26 window 28 light-emitting diode 30 counter/controller 32 switch 34 line-plus 36 line-ground 38 microprocessor 40 memory 42 data line 44 data line 46 data input 48 data output 59 signal line 52 signal line 54 series resistor

1a

FIELD OF THE INVENTION [0001] The present invention relates to toothbrushes and more particularly, to toothbrushes mounted on a finger and having shorter bristles adjacent the tip thereof to enhance access to and cleaning of the back teeth. BACKGROUND OF THE INVENTION [0002] Finger mounted toothbrushes are well known in the art as a low cost means of providing a toothbrush with enhanced control in brushing. Examples of such prior art toothbrushes are disclosed in U.S. Pat. Nos. 2,077,540, 2,915,767, 2,921,590, 3,583,019, 3,798,698, 4,134,172, 4,679,274 and 5,287,584, among others, all of which provide bristles or other tooth cleaning elements which generally have a generally flat bristle trim or a uniform bristle height, i.e. the length which the bristles extend from the surface of the finger toothbrush to which they are secured. To provide adequate access to the facial tooth surfaces of the rear molars, these prior art toothbrushes must fit between the narrowing distance between the facial surfaces of the teeth and the cheek near the rear of the mouth. Unfortunately, while the finger does thin towards its end, this thinning does not allow sufficient entry of the tip of these finger mounted prior art toothbrush with their generally uniform flat trim bristle height into the narrowed space between the facial side of the rear molars and the cheek to provide sufficient room for maneuvering and adequate cleaning. [0003] U.S. Pat. No. 4,617,694 discloses a toothbrush with a specially contoured bristle pattern disclosed as providing enhanced cleaning to all teeth, particularly to those at the rear of the mouth. The height or length of the bristles disclosed in this toothbrush increases uniformly toward the tip of the brush, i.e. the tip of the finger. This increasing bristle length toward the tip of the toothbrush, when the combined decreasing thickness of the finger toward the tip of the toothbrush (See, FIG. 1 in U.S. Pat. No. 4,617,694) keeps the total combined thickness of finger and bristles at a generally constant thickness. Such a constant thickness does not allow sufficient access of the tip of this finger mounted toothbrush into the narrowing space between the cheek and the facial surfaces of the rear molars, the same problem as disclosed herein above with respect to other prior art finger toothbrushes. [0004] Thus there is a clear need for a low cost finger toothbrush with a configuration that allows it to fit into the narrowing space between the cheek and the facial surfaces of the back molars to provide the desired cleaning thereof. BRIEF SUMMARY OF THE INVENTION [0005] The present invention encompasses a finger toothbrush wherein the bristles most adjacent the tip of the brush are the shortest in height as measured from the brush face and the bristles furthest from the tip of the brush are the longest as measured from the brush face. Providing such short bristles at the tip of the finger toothbrush reduces the overall height of the tip to allow it to adequately fit into the narrow space between the cheek and the facial surfaces of the rear molars to reach and clean the rear molars and surrounding gum tissues. Further, the longer bristles, located away from the tip of the subject finger toothbrush will provide a more pleasant softer feel to the user and an enhanced ability to penetrate into the interproximal spaces between the teeth for enhanced cleaning therein. [0006] Alternate embodiments of the present finger toothbrush invention include bristles which linearly ramp down in height as measured from the brush face to the shortest bristles adjacent the tip, or which arcuately ramp down in height, in for example a concave arc, measured from the brush face to the shortest bristles adjacent the tip (a concave arc which better conforms to the curvature of the teeth). The bristles, in the present finger toothbrush, may be grouped in conventional bristle tufts and aligned in rows, wherein the closest row or rows of tufts to the tip of the toothbrush are the shortest. BRIEF DESCRIPTION OF THE DRAWINGS [0007] The above disclosed and other features, objects and advantages of the present invention will be better understood from a reading of the detailed description of the preferred embodiment in conjunction with the following drawings, in which: [0008] [0008]FIG. 1 is a side view of a preferred embodiment of the finger toothbrush of the present invention; [0009] [0009]FIG. 1A is a side view of an alternative embodiment of the finger toothbrush of the present invention; [0010] [0010]FIG. 2 is a perspective view, showing the finger toothbrush of FIG. 1, wherein the bristles are mounted on a rigid plastic face enclosed in an elastomeric frame. [0011] [0011]FIG. 3 is a top view, showing the finger toothbrush of FIG. 1. [0012] [0012]FIG. 4 is a perspective view showing in isolation the elastomeric frame of FIG. 2. DETAILED DESCRIPTION OF THE INVENTION [0013] Referring to the drawings, wherein like reference numerals refer to the same or similar elements among the several figures, there is shown a finger toothbrush 10 in accordance with the present invention, i.e. the bristles or bristle tufts 16 closest to the tip 18 of the finger toothbrush 10 are the shortest bristles 16 and the bristles furthest from the tip 18 are the longest. In a first embodiment of the present invention shown in FIG. 1, the finger toothbrush 10 has a generally tubular finger grip section 20 extending along a portion of the length of the back-side 32 of a rigid platform 14 . The bristles 16 may be organized in a plurality of bristle tufts (also designed as 16 ) aligned in rows and securely mounted and extend from the front side or brush face 22 . The length or height of the rows of bristles or bristle tufts 16 from the face 22 , uniformly decrease along the longitudinal axis of the finger toothbrush 10 toward the tip 18 thereof, easing entry of the finger toothbrush 10 into the narrowing space between the cheek and the facial surface of the molars in the rear of the mouth for enhanced cleaning thereof. [0014] In a second embodiment of the present invention, as illustrated in FIG. 1A, the bristle tufts 16 decrease in height linearly in a 1st region furthest from the tip 18 of the finger toothbrush 10 and continue to decease in height in a 2nd region until the shortest tufts of a uniform height is reached for the bristle tufts 16 nearest the tip 18 . In another alternate embodiment, the bristle tufts 16 may be uniform as well as decreasing in height in the 1st region furthest from the tip 18 of the finger toothbrush 10 and then continue to decease in height in a 2nd region until the shortest tufts of a uniform height is reached for the bristle tufts 16 nearest the tip 18 . Finally, in a third alternate embodiment, the bristles may decrease in height in an arcuately along the length or part of the length of the brush face 22 , in for example a concave curve which is concave towards the brush face 22 , such that the shortest bristle tufts 16 are adjacent to the brush tip 18 and the tallest bristle tufts 16 are furthest from the brush tip 18 . [0015] Referring again to FIG. 1, the row of bristles furthest from the tip 18 of the finger toothbrush 10 of the present invention extend from the face 22 a height of about 8 to about 14 mm, preferably about 8 to about 11 mm and most preferably about 9 mm. The bristles nearest the tip 18 of the finger toothbrush 10 extend from the face 22 a height of about 4 to about 7 mm, preferably about 5 to 7 mm, and most preferably about 6 mm. [0016] The generally tubular finger grip section 20 may be integrally mounted to the edges 30 of the rigid platform 14 or to the back-side 32 of the rigid platform 14 itself, preferably being mounted along the edges 30 right at the juncture of the edges 30 and the rigid platform 14 (see FIG. 4). The diameter of the tube aperture through the tubular finger grip section 20 may be from about 1.5 to about 2.5 mm, preferably about 2.0 mm. The tubular finger grip section 20 may contain a slit 36 , aligned in the general direction of the longitudinal axis of the finger toothbrush and extending 40%, 50% or more of the length of the tubular finger grip section 20 toward the tip of the toothbrush 18 . This slit 36 provides added flexibility to the tubular finger grip section 20 to accommodate larger fingers. [0017] The cross-section of the monofilament bristles 16 , useful in the present invention may be circular, oval, rectangular or polygonal, with a diameter or is largest cross-sectional dimension of from about 0.10 mm to about 0.40 mm or more. The monofilament bristles 16 may be made of the same or different polymeric materials, including aliphatic polyamides, aromatic polymides, polyesters, polyolefins, styrenes, fluoropolymers, polyvinylchloride (PVC), polyurethane, polyvinylidene chloride, and polystyrene and styrene copolymers, or combinations thereof. A preferred material is 6,12 nylon; though other nylons may be used, including 4 nylon, 6 nylon, 11 nylon, 12 nylon, 6,6 nylon, 6,10 nylon, 6,14 nylon, 10,10 nylon, 12,12 nylon and other nylon co-polymers. A particularly preferred 6,12 nylon is sold under the tradename TYNEX®, and is manufactured by E.I. DuPont de Nemours and Company of Wilmington, Del. [0018] The finger toothbrush 10 of the present invention may be formed of an external rubber or elastomeric frame 24 shown in FIG. 4 into which a more rigid plastic is overmolded, to form the completed finger toothbrush as illustrated in FIGS. 1 to 3 . The elastomeric frame 24 provides cushioning and an avoidance of abrasion to the soft tissues of the cheek and gums and the rigid overmolded plastic provides a rigid structure to the finger toothbrush 10 and a means to securely fasten the bristles 16 therein. To provide such cushioning and abrasion avoidance, the elastomeric frame 24 may be manufactured of natural rubber or a thermoplastic elastomer (TPE), or a combination thereof. Such acceptable materials include thermoplastic vulcanate (TPV) which consists of a mixture of polyproplyene and EPDM (ethylene propylene diene monomers) which is available as Santoprene (brand), described in U.S. Pat. No. 5,393,796; or Vyram (brand), another TPV consisting of a mixture of polypropylene and natural rubber; both Santoprene and Vyram being elastomers marketed by Advanced Elastomer Systems LP, Akron, Ohio 44311. Another, and preferred TPE is Dynaflex G6713 (brand), marketed by GLS Corp., Cary, Ill. 60013. These and other suitable elastomers typically have a Shore A hardness of from about 13 to 94, with about 29 being a preferred hardness. The elastomeric frame 24 should be at least 0.5 mm in thickness, preferably at least 1.59 mm in thickness, though the thickness need not be uniform about the entire body of the elastomeric frame 24 . [0019] The overmolded rigid plastic, about the elastomeric frame shown in FIG. 4, includes a rigid platform 14 having a plurality of bristle holes in the face 22 thereof, into which holes the rows of bristles 16 are fastened, preferably using conventional staple technology. The overmolded rigid plastic is preferably manufactured of a thermoplastic, especially polypropylene, though other rigid plastic materials, such as polyester may be used. A suitable polypropylene, with a flexural modulus of 216,000 psi (15,186 kilograms/cm 2 ) by ASTM test method D790, is available from Huntsman Corporation, Longview, Tex., 75603 under the trade-designation Huntsman Polypropylene P4G3Z-039. Another suitable polypropylene is available from Amoco Polymers, Inc., Alpharetta, Ga. 30202-3914, sold under the trade designation 7635 with a flexural modulus of about 275,000 psi (19,334 kilograms/cm 2 ). Use of a toothbrush handle of such a 216,000 psi (15,186 kilograms/cm 2 ) to 275,000 psi (19,334 kilograms/cm 2 ) material will provide enhanced rigidity to allow the rows of bristles 16 to be securely fastened therein. [0020] The manufacture of toothbrushes of the present invention can be facilitated by using known, conventional two-step injection molding processes. Within such a two-step injection molding process, the elastomeric frame 24 is initially injection molded. The elastomeric frames are then positioned within a second mold and the rigid plastic is injection molded about the elastomeric frame 24 , to form the completed finger toothbrush body. Finally the bristles 16 are secured to the rigid plastic platform by known manufacturing techniques, including the use of conventional staple technology. [0021] Conventional two component injection molds useful in the manufacture of the present invention are available from Machines Boucherie NV, Izegem, Belgium. Which molds can be mounted in typical injection molding machines, such as 300 ton injection molding machines available from Engel Canada, Inc., Guelph, Ontario.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of Invention [0002] An aspect of the present invention relates to a method to determine a right intensity for one's fitness level based on results of an exercise stress test. [0003] 2. Description of Related Art [0004] Several parameters are known to be useful indicators o determine the appropriate exercise intensity in the training or in the ergo therapy or to evaluate functions of the respiratory organs system and circulatory organ system. [0005] The several parameters includes a threshold level at which the blood lactate concentration begins an upward trend (the conversion from aerobic exercise to anaerobic exercise is considered to occur at the threshold level), the lactate threshold value that is expressed as the numerical value of oxygen uptake, the ventilatory threshold value at which of a sudden increase of the carbon dioxide in the expiration is observed according to the exercise load strength and the anaerobic threshold value. [0006] The above parameters are generally observed or monitored invasively. [0007] On the contrary, a method to determine a right intensity of fitness level or exercise stress based on amplitudes of heart sound has been proposed. Amplitudes of heart sound can be observed or monitored noninvasively. SUMMARY OF THE INVENTION [0008] An object of an aspect of the present invention is to determine a safe and right intensity of one's fitness level or exercise stress. [0009] A first aspect of the present invention is related to a method for determining a right intensity for fitness level or exercise stress that includes a first step of inspection a first change of amplitudes of a first heart sound with regard to a second change of intensities of exercise stress, a second step of inspection of a third change of ratios of a first length of a cardiac dilation period relative to a second length of one cardiac cycle with regard to the second change, a third step of identification of a folding point of the first change, and a fourth step of determination of an intensity of the intensities at the folding point as the tight intensity of exercise stress if a ratio of the ratios at the intensity is higher than a predetermined value. [0010] A second aspect of the present invention is related to a method for determining a right intensity of exercise stress that includes a first step of inspection of a first change of amplitudes of a first heart sound with regard to a second change of intensities of exercise stress, a second step of inspection of a third change of ratios of a first length of a cardiac dilation period relative to a second length of one cardiac cycle with regard to the second change, a third step of identification of a first intensity at a first folding point of the first change a fourth step of identification of a second intensity at a second folding point of the third change, and a fifth step of determination of the second intensity as the right intensity of exercise stress if the second intensity is lower than the first intensity. [0011] A third aspect of the present invention is related to a method for determining a right intensity of exercise stress that includes a first step of inspection of a fourth change of ratios of a first length of a cardiac dilation period relative to a second length of one cardiac cycle with regard to a fifth change of intensities of exercise stress, a second step of identification of a folding point of the fourth change, and a third step of determination of an intensity at the folding point as the right intensity of exercise stress. [0012] The amplitudes of a first heart sound with regard to a second change of intensities of exercise stress changes suddenly in the vicinity of the first folding point. [0013] The of ratios of the first length of a cardiac dilation period relative to the second length of one cardiac cycle changes suddenly in the vicinity of the second folding point. [0014] The first change may be obtained under a resting condition or after an exercise stress in any one of the above methods. [0015] The method may further include a step of evaluation of whether a person being tested is in exercise condition or not by an acceleration sensor. [0016] The acceleration sensor may be attached to a part of a body in any one of the above methods. [0017] The acceleration sensor may be a waist or an arm of the person being tested. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 shows a block diagram for the measuring processing procedure in an exemplified experiment. [0019] FIG. 2 shows a cardiac electronic signal waveform (waveform 1 ) and a cardiac sound waveform (waveform 2 ). [0020] FIG. 3 shows changes of amplitude of first heart sound S 1 (mV), ratio of a length of a cardiac dilation period relative to a length of one cardiac cycle (%), epinephrine concentration (pg/ml) and blood lactate concentration (mmol/l) according to change of intensity of an exercise stress after 10 times of heart beats from the end of the exercise stress. [0021] FIG. 4 shows a comparison between a change of amplitude of the first heart sound during exercise and a change of amplitude of the first heart sound after exercise. [0022] FIG. 5 shows changes of ratio of a length of a cardiac dilation period relative to a length of one cardiac cycle for 10 seconds before and after the end of exercise stress whose intensity is 50 watt. [0023] FIG. 6 shows changes of ratio of a length of a cardiac dilation period relative to a length of one cardiac cycle for 10 seconds before and after the end of exercise stress whose intensity is 100 watt. [0024] FIG. 7 shows changes of ratio of a length of a cardiac dilation period relative to a length of one cardiac cycle for 10 seconds before and after the end of exercise stress whose intensity is 150 watt. [0025] FIG. 8 shows changes of ratio of a length of a cardiac dilation period relative to a length of one cardiac cycle for 10 seconds before and after the end of exercise stress whose intensity is 200 watt. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0026] An exemplified embodiment regarding with the present invention will be explained in reference to drawings below. [0027] FIG. 1 shows a block diagram that shows measuring means employed in the exemplified embodiment. [0028] A cardiac rate is estimated from an electrocardiogram. A cardiac sound is recorded by a microphone attached to a breast. The microphone is covered by a plastic cover having a dome shape. The cardiac sound and the cardiac electronic signal corresponding to a cardiac electrogram were taken in a personal computer through an A/D converter after amplification of the cardiac sound and the cardiac electronic signal. [0029] An output from an acceleration sensor attached to a part of body is taken in a personal computer thorough an A/D converter after amplification of the output. [0030] The acceleration sensor was attached to the lumbar part of a person being tested (23 years old, male, height: 173.5 cm, weight: 70.1 kg) and used for detecting exercise condition of the person being tested. [0031] FIG. 2 shows cycles of the person's heart. Waveform 1 and waveform 2 shown in FIG. 2 correspond to a cardiac electrogram waveform and a cardiac sound waveform, respectively. [0032] The period from R 1 to R 2 corresponds to one cardiac cycle. A first heart sound S 1 appears after the appearance of R wave corresponds to a closing sound of mitral valve or eustachian valve, or an opening sound of the aortic valve. [0033] A second heart sound S 2 appears after the appearance of T wave corresponds to a closing sound of the aortic valve. [0034] A ratio of a length of a cardiac dilation period relative to a length of one cardiac cycle is estimated by dividing a value obtained by subtracting the length of the period from S 2 to S 1 from the length of the period from R 1 to R 2 by the length of the period from R 1 to R 2 . [0035] The heart may become ischemic if the ratio of the length of the cardiac dilation period relative to the length of one cardiac cycle is extremely low because oxygen is supplied to myocardium during the cardiac dilation period. The ratio should be higher than 50% for narrowing of coronary arteries for safety's sake. [0036] FIG. 3 shows changes of amplitude of first heart sound S 1 (mV), ratio of a length of cardiac dilation period relative to a length of one cardiac cycle (%), epinephrine concentration (pg/ml) and blood lactate concentration (mmol/l) according to change of exercise stress intensity after 10 times of heart beats from the end of the exercise. [0037] HSBP (Heart Sound Break Point) where the amplitude of the first cardiac sound changes sharply appears at around 120 watt clearly. [0038] Epinephrine concentration begins an upward trend in the vicinity of the HSBP. [0039] Blood lactate concentration begins also an upward trend in the vicinity of the HSBP. [0040] It is can be concluded that change of the amplitude of first cardiac sound according to change of load strength of the exercise or intensity of the exercise stress correlates with changes of epinephrine concentration and blood lactate concentration according to change of load strength of the exercise or intensity of the exercise stress. [0041] This indicates that a right intensity of fitness level or exercise stress can be determined by examining change of the amplitude of the first cardiac sound, which can be observed noninvasively. [0042] As mentioned above, it is possible to determine a right intensity of fitness level or exercise stress based on change of amplitude of first cardiac sound. [0043] It is preferable to consider length of cardiac dilation period to assure safeness in addition to change of amplitude of the first cardiac sound. [0044] If a criterion ratio of the length of cardiac dilation period relative to the length of period of one cardiac cycle below which is contraindicated with a patient is known in advance, it is possible to determine a safe and right fitness level of patient based on the criterion ratio. [0045] For example, it is preferable to confirm that the criterion ratio of the length of cardiac dilation period relative to the length of the period of one cardiac cycle is higher than 50% at a right intensity of exercise stress estimated from amplitude of first cardiac sound because this may cause ischemia of a patient with a symptom such as narrowing of coronary arteries if the ratio of length of cardiac dilation period relative to length of period of one cardiac cycle is 50% or less. [0046] In the exemplified embodiment, a right intensity of exercise stress estimated from amplitude of first cardiac sound may be safe because a ratio of the length of cardiac dilation period relative to length of period of one cardiac cycle at (HSBP) is higher than 50%. [0047] It is desirable to pay attention to a folding point of the change of the ratio of the length of cardiac dilation period relative to the length of the period of one cardiac cycle to determine an safe exercise strength. [0048] As shown in FIG. 3 , the change of the ratio of length of cardiac dilation period relative to length of period of one cardiac cycle has a folding point ranging from 80 watt to 90 watt where a sharp change is observed. The folding, point corresponds to change of cardiac burden. [0049] It is preferable to determine intensities between 80 watt and 90 watt as a right intensity for a severe patient. A right intensity of exercise stress for the severe patient can be estimated from a folding point of the change of ratio of the length of cardiac dilation period relative to length of the period of one cardiac cycle. [0050] Changes of amplitude of first heat sound and ratio of length of cardiac dilation period relative to length of the period of one cardiac cycle are useful indicators to determine a safe and appropriate intensity of exercise stress. [0051] If an intensity corresponding to a folding point of change of ratio of the length of cardiac dilation period relative to the length of the period of one cardiac cycle is lower than an intensity corresponding to folding point of change of amplitude of the first heat sound a right intensity of exercise stress can be easily determined only based on change of ratio of length of cardiac dilation period relative to length of period of one cardiac cycle. [0052] FIG. 4 shows a comparison between a change of amplitude of the first heart sound during exercise and change of amplitude of first heart sound after exercise. [0053] Change of amplitude of first heart sound during exercise was obtained by averaging amplitudes of first heart sound detected with almost no noise during 30 seconds before the end of an ergometer exercise. [0054] Change of amplitude of first heart sound after exercise was obtained by averaging amplitudes of first heart sound detected during ten times of heart beats just after the ergometer exercise. [0055] A folding point obtained from amplitude of first heart sound after exercise appears more clearly than a folding point obtained from amplitude of first heart sound during exercise as shown in FIG. 4 . [0056] It is possible to easily determine an appropriate intensity of exercise stress by inspecting amplitudes of the first heat sound just after exercise. [0057] As mentioned above, it is preferable to inspect amplitudes of first heat sound just after exercise to determine an appropriate intensity of exercise stress. [0058] An acceleration sensor can be used for inspection of exercise condition. The acceleration sensor may be attached a body of a person being tested. [0059] An acceleration sensor may be attached to a pectoral region. In this case, the acceleration sensor may be used as a microphone for detecting heat sounds. [0060] An acceleration sensor may be attached to a part of body to which a microphone is attached. [0061] It is necessary to inspect change of ratio of length of cardiac dilation period relative to length of period of one cardiac cycle during exercise to determine a right intensity of exercise stress exactly. However, it is difficult because of noise generated during exercise. [0062] However, As shown in figures form 5 to 8 , there is little difference between change of ratio of length of cardiac dilation period relative to length of period of one cardiac cycle during exercise and change of ratio of length of cardiac dilation period relative to length of period of one cardiac cycle during 10 seconds just after the end that exercise. [0063] Therefore, it is proper to determine a right intensity of exercise stress based on change of ratio of length of cardiac dilation period relative to length of period of one cardiac cycle during a short period just after the exercise. [0064] If a criterion ratio of length of cardiac dilation period relative to length of period of one cardiac cycle is set to be higher than 50%, a ratio of length of cardiac dilation period relative to length of the period of one cardiac cycle for 50 watt of intensity of exercise stress and a ratio of length of cardiac dilation period relative to length of the period of one cardiac cycle for 50 watt of intensity of exercise stress are higher than 50% together. [0065] Accordingly, a right intensity of exercise stress can be considered to be in the range from 50 watt to 100 watt. This correlates with that the folding point of change of ratio of length of cardiac dilation period relative to length of the period of one cardiac cycle as described above.

1a

FIELD OF THE INVENTION [0001] The present invention is directed to medicament-containing chewing gum compositions. In particular, the present invention is directed to chewing gum compositions, which effectively mask the unpleasant tastes of compounds according to formula I contained therein and methods for preparing such chewing gum. TECHNICAL BACKGROUND OF THE INVENTION [0002] People suffering from hay fever, seasonal allergy, and allergy to other substances (such as dust mites, animal dander, and molds), including runny nose, sneezing, and red, itchy, tearing eyes commonly take medications called antihistamines for symptomatic relief. [0003] It is commonly accepted that one group of useful antihistamines is active compounds such as 2-[4-(diphenylmethyl)-1-piperazine] derivatives having the general formula I: [0000] [0000] wherein [0004] R 1 is selected from the group consisting of —CH 2 CH 2 -0-CH 2 —R 2 , —CH 2 CH═CH—Ar 1 , —CH 2 —Ar 2 and [0000] [0005] R 2 may be selected from the group consisting of a —CH 2 OH group, a —COOH group and a —CONH 2 group; [0006] Ar 1 and Ar 2 are independently an aromatic or heteroaromatic ring with 5 or 6 atoms in the ring, said heteroaromatic ring having 1, 2 or 3 heteroatoms selected from the group consisting of nitrogen, oxygen and sulfur, said ring being unsubstituted or substituted with C 1-4 alkyl, preferably methyl or tertiary butyl, Ar 1 and Ar 2 preferably being unsubstituted phenyl or phenyl substituted with C 1-4 alkyl, preferably methyl or tertiary butyl; and [0007] X 1 and X 2 may independently be selected from the group consisting of a hydrogen atom, a halogen atom, a straight-chain or branched C 1 -C 4 alkoxy group or a trifluoromethyl group; as well as pharmaceutically acceptable salts, geometrical isomers, enantiomers, diastereomers and mixtures thereof. [0008] In the present context, the term “C 1-4 -alkoxy” is intended to mean C 1-4 -alkyl-oxy, such as methoxy, ethoxy, n-propoxy, isopropoxy, n-butoxy, isobutoxy, sec-butoxy and tert-butoxy. Furthermore, the term “halogen” includes fluorine, chlorine, bromine and iodine. [0009] One of the most popular and effective antihistamines is cetirizine, which in its dihydrochloride form marketed under the tradename Zyrtec®, the (S)-enantiomer thereof, levocetirizine, in its dihydrochloride form marketed under the trade name Xyzal® and efletirizine in its dihydrochloride form. [0010] This medicament however is very bitter and has a highly unacceptable taste. Accordingly, it is usually administered in syrups where masking of the bitter taste is relatively easy. Cetirizine has also been incorporated in tablets. Such tablets are formulated as white, film-coated, rounded-off rectangular shaped tablets so that its displeasing organoleptic qualities completely bypass the sense of taste. [0011] Attempts to incorporate cetirizine in chewing gums, however, have yielded products, which are generally unacceptable. Some cetirizine-containing chewing gums have been found to have the bitter taste, and unacceptable flavour associated with this agent become especially noticeable after the first two to five minutes of chewing. In other chewing gum products, cetirizine has been coated in waxes in order to combat the unpleasant taste. [0012] For example in US 2005/0038039 an oral pharmaceutical composition is described containing at least two separate formulations: a first formulation, which contains an active compound according to the above formula I and which first formulation does not contain polyols having a molecular weight of less than 300 in a molar ratio between the polyol and active compound of formula I above 10; and a second formulation, which contains one or more polyol(s) with a molecular weight of less than 3000 and is free of any drug. [0013] It is a well-known problem in the chewing gum industry to find suitable agents, which both mask the bitter taste of active compounds and give good palatability to medicated chewing gums. As it has been shown that the above-mentioned taste-masking agents are the most useful agents, there is an industrial need to find a solution to how these agents can be used in medicated chewing gums. SUMMARY OF THE INVENTION [0014] Thus, the present invention provides a medical formulation of an active compound according to formula I having a consumer acceptable taste and good palatability. Accordingly, in a first aspect, the present invention relates to a compressed chewing gum tablet comprising at least one active compound selected from 2-[4-(diphenylmethyl)-1-piperazine] derivatives having the general formula I: [0000] [0000] wherein [0015] R 1 is selected from the group consisting of —CH 2 CH 2 —O—CH 2 —R 2 , —CH 2 CH═CH—Ar 1 , —CH 2 —Ar 2 and [0000] [0016] R 2 may be selected from the group consisting of a —CH 2 OH group, a —COOH group and a —CONH 2 group; [0017] Ar 1 and Ar 2 are independently an aromatic or heteroaromatic ring with 5 or 6 atoms in the ring, said heteroaromatic ring having 1, 2 or 3 heteroatoms selected from the group consisting of nitrogen, oxygen and sulfur, said ring being unsubstituted or substituted with C 1-4 alkyl, preferably methyl or tertiary butyl, Ar 1 and Ar 2 preferably being unsubstituted phenyl or phenyl substituted with C 1-4 alkyl, preferably methyl or tertiary butyl; and [0018] X 1 and X 2 may independently be selected from the group consisting of a hydrogen atom, a halogen atom, a straight-chain or branched C 1 -C 4 alkoxy group or a trifluoromethyl group; as well as pharmaceutically acceptable salts, geometrical isomers, enantiomers, diastereomers and mixtures thereof; [0019] a taste-masking agent and a first compressed module comprising compressed chewing gum particles containing gum base; and wherein the weight ratio between the taste-masking agent and the compound according to formula I is at least 5:1. [0020] Without being bound theory, the inventors suggest that the obtained good taste and palatability of the present chewing gum tablet is achieved by providing a well-balanced ratio between the active compound according to formula I and the taste-masking agent in combination with the use of compressed particles containing gum base. This combination results in an effective masking of the bitter taste of the active compound, as well as an acceptable texture and an interesting taste experience. [0021] It has further been found that when the active compound and the taste-masking agent are positioned as described in detailed below, the medicament and the agent are co-released upon chewing resulting in an effective masking of the medicaments bitter taste. [0022] In a further aspect of the present invention there is provided a method of preparing a compressed chewing gum tablet according to the invention comprising one compressed module, the method comprising the steps of: a) providing a portion comprising an active compound according to formula I, a portion comprising taste-masking agent, and chewing gum particles containing gum base; b) optionally providing one or more further chewing gum ingredients; c) dosing the portion comprising the compound according to formula I, the portion comprising taste-masking agent, and the chewing gum particles containing gum base, and optionally the one or more further chewing gum ingredients; and d) compressing a) and b) after dosing, to obtain a first compressed module. [0023] In a still further aspect, the present invention provides a method of preparing a compressed chewing gum tablet according to the invention comprising one compressed module, the method comprising the steps of: a) providing a portion comprising an active compound according to formula I, a portion comprising taste-masking agent, and chewing gum particles containing gum base; b) optionally providing one or more further chewing gum ingredients; c) mixing the portion comprising the compound according to formula I, the portion comprising taste-masking agent, and the chewing gum particles containing gum base, and optionally the one or more further chewing gum ingredients, thus obtaining a mixture; and d) compressing the mixture to obtain a first compressed module. [0024] Yet further, the present invention provides a method of preparing a compressed chewing gum tablet according to the invention comprising two compressed modules, the method comprising the steps of: a) providing chewing gum particles containing gum base and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising an active compound according to formula I and a portion comprising a taste-masking agent; c) compressing a) to obtain a first compressed module; d) contacting the first compressed module with b); and e) compressing b) and the first compressed module, to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module. [0025] In a still further aspect, there is provided a method of preparing a compressed chewing gum tablet according to the invention comprising two compressed modules, the method comprising the steps of: a) providing chewing gum particles containing gum base and a portion comprising an active compound according to formula I, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising taste-masking agent; c) compressing a) to obtain a first compressed module; d) contacting the first compressed module with b); and e) compressing b) and the first compressed module, to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module. [0026] A further aspect relates to a method of preparing a compressed chewing gum tablet according to the invention comprising three compressed modules, the method comprising the steps of: a) providing chewing gum particles containing gum base, a portion comprising a taste-masking agent, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising tablet material and optionally a portion comprising an active compound according to formula I; c) providing a portion comprising tablet material and a portion comprising an active compound according to formula I; and d) locating b) and c) on opposite sites of a) following a sequence of one or more compressing step(s), to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module and a third compressed module. [0027] In a further aspect, there is provided a method of preparing a compressed chewing gum tablet according to the invention comprising three compressed modules, the method comprising the steps of: a) providing chewing gum particles containing gum base, a portion comprising an active compound according to formula I, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising tablet material and optionally a portion comprising a taste-masking agent; c) providing a portion comprising tablet material and a portion comprising a taste-masking agent; and d) locating b) and c) on opposite sites of a) following a sequence of one or more compressing step(s), to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module and a third compressed module. [0028] A final aspect relates to a method of preparing a compressed chewing gum tablet according to the invention comprising three compressed modules, the method comprising the steps of a) providing chewing gum particles containing gum base, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising tablet material and a portion comprising an active compound according to formula I and a portion comprising a taste-masking agent; c) providing a portion comprising tablet material and a portion comprising an active compound according to formula I and a portion comprising a taste-masking agent; and d) locating b) and c) on opposite sites of a) following a sequence of one or more compressing step(s), to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module and a third compressed module. BRIEF DESCRIPTION OF THE FIGURES [0029] The invention will now be described with reference to the drawings of which [0030] FIGS. 1 a - 1 b illustrate a two-layer compressed tablet according to an embodiment of the invention, [0031] FIGS. 2 a - 2 b illustrate a three layer compressed tablet according to an embodiment of the invention, [0032] FIGS. 3 a - 3 b illustrate a further two layer compressed tablet according to an embodiment of the invention, [0033] FIGS. 4 a - 4 b illustrate a further two layer compressed tablet according to an embodiment of the invention, and where [0034] FIGS. 5 a - 5 b illustrate a further two layer compressed tablet according to an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION Definitions [0035] In the present context, the expression “taste-masking agent” relates to one or more agents or compounds which, optionally together, successfully mask or cover the bitter taste of the compound according to formula I, but which simultaneously provide the chewing gum a good palatability. In a preferred embodiment, the taste-masking agent comprises a polyol sweetener. [0036] In the present context, the term “gum base” refers in general to a commercially available gum base suitable for production of chewing gum. Such gum bases normally comprise one or more elastomeric compounds which may be of synthetic or natural origin, one or more resinous compounds which may be of synthetic or natural origin and softening compounds. [0037] The term “gum base composition” as used herein may be a gum base as defined above comprising one or more ingredients (e.g. sweetener, flavour, colouring agents, fillers etc.) as described below. [0038] The term “chewing gum composition” is the final formulation, which constitutes at least a part of the compressed chewing gum tablets ready for sale or use by the consumer. A chewing gum composition may comprise an active compound according to formula I, a taste masking agent, sweetener and/or flavour and optionally other ingredients like colouring agents, enzymes, humectants, flavour enhancers, anticaking agents etc. [0039] Furthermore, the expression “compressed chewing gum tablets” denote a ready for use chewing gum tablet, e.g. comprising compressed particles containing gum base possibly mixed with an active compound according to formula I, a taste-masking agent, sweeteners, flavour or other ingredients and optionally coated. As described in detail below, a compressed chewing gum tablet is produced by an initial conventional mixing of the gum base with e.g. water-insoluble ingredients such as elastomers and resins, followed by a granulation or the like of the obtained gum base mix. The obtained particles containing gum base may then be mixed with further chewing gum ingredients, such as an active compound according to formula I, a taste-masking agent, sweeteners and flavours. The final mix may then be compressed under high pressure (typically when applying cooling) into to a compressed chewing gum tablet or a compressed module. [0040] Thus, the expression “chewing gum particles containing gum base” refers to particulated material of chewing gum composition and is to be understood as any form of chewing gum particles containing a certain amount of gum base as described in detail below. The chewing gum particles may be in any suitable form such as pellets, granules, agglomerates, powder. Thus, in some embodiments, the particles have been particulated prior to application. Particulation may be in any form of “building up” particles from smaller primary particles into macro particles or in any form of “building down” from larger substances into macro particles. Any form of particulation may be applied, such as granulation, pelletizing, agglomeration, or any other suitable means for particulation, as described below. Thus, the particles may also to be understood as macroparticles. [0041] Furthermore, the expression “compressed chewing gum particles containing gum base” refers to a portion of chewing gum particles which become compressed after mixed with e.g. an active compound according to formula I, a taste-masking agent, sweeteners or flavours. Preferred Embodiments [0042] The present invention relates to a medicated chewing gum tablet with an effective amount of an active compound according to formula I, having a costumer acceptable taste during all chewing phases. [0043] This is achieved by preferably placing the compound according to formula I and a taste-masking agent in the chewing gum in such a way that, upon chewing, some of the taste-masking agent releases when the compound releases. The inventors of the present invention found, that such a co-release of the compound according to formula I and the taste-masking agent results in an effective masking of the bitter taste of the compound. This masking effect does not depend on the release of the whole portion of taste-masking agent. Thus, under some circumstances, the compound and the taste-masking agent are positioned in such a way that, upon chewing, not all taste-masking agent releases during the release of the compound according to formula I. [0044] Accordingly, the present invention provides a compressed chewing gum tablet comprising at least one active compound selected from 2-[4-(diphenylmethyl)-1-piperazine] derivatives having the general formula I: [0000] [0000] wherein [0045] R 1 is selected from the group consisting of —CH 2 CH 2 —O—CH 2 —R 2 , —CH 2 CH═CH—Ar 1 , —CH 2 —Ar 2 and [0000] [0046] R 2 may be selected from the group consisting of a —CH 2 OH group, a —COOH group and a —CONH 2 group; [0047] Ar 1 and Ar 2 are independently an aromatic or heteroaromatic ring with 5 or 6 atoms in the ring, said heteroaromatic ring having 1, 2 or 3 heteroatoms selected from the group consisting of nitrogen, oxygen and sulfur, said ring being unsubstituted or substituted with C 1-4 alkyl, preferably methyl or tertiary butyl, Ar 1 and Ar 2 preferably being unsubstituted phenyl or phenyl substituted with C 1-4 alkyl, preferably methyl or tertiary butyl, and [0048] X 1 and X 2 may independently be selected from the group consisting of a hydrogen atom, a halogen atom, a straight-chain or branched C 1 -C 4 alkoxy group or a trifluoromethyl group; as well as pharmaceutically acceptable salts, geometrical isomers, enantiomers, diastereomers and mixtures thereof; [0049] a taste-masking agent and a first compressed module comprising compressed chewing gum particles containing gum base, wherein the weight ratio between the taste-masking agent and the compound according to formula I is at least 1:5, and preferably at least 5:1. The Taste-Masking Agent [0050] As defined above, the taste-masking agents are one or more agents or compounds which, optionally together, successfully mask or cover the bitter taste of the compound according to formula I, but which simultaneously provide the chewing gum a good palatability. In a preferred embodiment, the taste-masking agent comprises a polyol sweetener. [0051] In useful embodiments, the polyol sweetener is a sugar which may be selected from the group consisting of dextrose, sucrose, maltose, fructose and lactose. [0052] In another preferred embodiment, the chewing gum comprises a polyol sweetener, which is a sugar alcohol. A useful sugar alcohol may be selected from the group consisting of xylitol, sorbitol, mannitol, maltitol, isomaltol or isomalt, erythritol, lactitol, maltodextrin and hydrogenated starch hydrolysates. [0053] The taste masking agent, when comprising a polyol sweetener, may be used in an amount in the range of 90-100% by weight of the taste masking agent, preferably in the range 95-99.9% and even more preferred in the range 97-99.5% by weight of the taste masking agent. [0054] The presence of mannitol in the compressed chewing gum tablet surprisingly appears to improve the stability of the active compound according to formula I relative to chewing gum tablets containing other low molecular weight polyol sweeteners such as sorbitol. Thus, in a preferred embodiment of the invention, the polyol sweetener of the compressed chewing gum tablet comprises mannitol in an amount of at least 25% by weight of the total amount of polyol sweetener of the compressed chewing gum tablet, such as in an amount of at least 50% by weight, preferably in an amount of at least 75%, and even more preferred in an amount of at least 95% by weight of the total amount of polyol sweetener of the compressed chewing gum tablet. In an embodiment of the invention, substantially all polyol sweetener of the compressed chewing gum tablet is mannitol. [0055] In another embodiment of the invention, the polyol sweetener of the second compressed module comprises mannitol in an amount of at least 25% by weight of the total amount of polyol sweetener of the second compressed module, such as in an amount of at least 50% by weight, preferably in an amount of at least 75%, and even more preferred in an amount of at least 95% by weight of the total amount of polyol sweetener of the second compressed module. [0056] In an embodiment of the invention, substantially all polyol sweetener of the second compressed module is mannitol. [0057] In an interesting embodiment, the chewing gum according to the invention is one wherein the taste-masking agent comprising a high intensity sweetener or a flavour. Useful high intensity sweetener may be selected from the group consisting of sucralose, neotame, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones e.g. NHDC, thaumatin, monellin, stevioside, Twinsweet (aspartame-acesulfame salt) and combinations thereof. [0058] Such a high intensity sweetener may be used in the chewing gum according to the invention in an amount in the range of 0.01-5% by weight of the taste masking agent, preferably in the range 0.1-2% and even more preferred in the range 0.4-1.5% by weight of the taste masking agent. [0059] In an interesting embodiment, the taste-masking agent comprises one or more high intensity sweetener in an amount in the range of 0.01-5% by weight of the taste-masking agent and one or more polyol sweetener in an amount in the range of 90-100% by weight of the taste masking agent, and preferably the taste-masking agent comprises high intensity sweetener in an amount in the range of 0.1-2% by weight of the taste-masking agent and polyol sweetener in an amount in the range of 98-99.9% by weight of the taste masking agent. [0060] Under some circumstances it may be desirable to use more than one taste-masking agent. Thus, in a useful embodiment, the chewing gum tablet according to the invention is one, which comprises an additional taste-masking agent and may, optionally, be located between the compressed chewing gum particles containing gum base. Such additional taste-masking agent may be selected from the group consisting of a salt of gluconate, such as e.g. sodium gluconate. Compound According to Formula I [0061] Active compounds according to formula I may be added at any time during the process of preparing the chewing gum. However, it is presently preferred that the active compounds are added to the chewing gum subsequent to any significant heating or mixing. In other words, the active compounds should preferably be added immediately prior to the compression of the final tablet. Referring to the process described below, the adding of active compounds may be cautiously blended with pre-mixed gum base particles and further desired ingredients, immediately prior to the final compression of the tablet. [0062] The active compounds according to formula I are preferably orally active and selective histamine Hi-receptor antagonists. In preferred embodiments of the invention, the active compound according to formula I is so selected that X 1 is a hydrogen atom, X 2 is a halogen atom, and R 1 is —CH 2 CH 2 -0-CH 2 —COOH. Preferably, the active compound according to formula I is a salt, e.g. a dihydrochloride salt. [0063] In another embodiment of the invention, the active compound according to formula I is selected from the group consisting of buclizine, cetirizine, chlorcyclizine, cinnarizine, cyclizine, hydroxyzine, levocetirizine, meclozine, efletirizine and oxatomide, as well as any pharmaceutically acceptable salts, geometrical isomers, enantiomers, diastereomers and mixtures thereof. [0064] Useful active compounds according to formula I may be selected from the group consisting of is cetirizine, the dihydrochloride salt of cetirizine, levocetirizine, the dihydrochloride salt of levocetirizine, efletirizine, and the dihydrochloride salt of efletirizine. [0065] In a preferred embodiment, the active compound according to formula I is cetirizine, i.e. 2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]acetic acid having the following formula II: [0000] [0000] or a salt thereof, preferably cetirizine dihydrochloride. [0066] It has been found, that a well-balanced ratio between cetirizine and a taste-masking agent in combination with the use of compressed particles containing gum base results in a pleasant taste experience and excellent texture of the chewing gum tablet, as well as an effective masking of the bitter taste of cetirizine. [0067] In embodiments of the invention, the chewing gum comprises the compound according to formula I, e.g. cetirizine or cetirizine dihydrochloride, in an amount in the range of 0.1-50 mg, preferably in the range of 1-30 mg, and even more preferably in the range of 5-25 mg. [0068] As will be apparent to the person skilled in the art, the active compound according to formula I can be used for the present invention in any suitable form, which includes encapsulates, complexes, or clathrates of the active compound according to formula I. Different Types of Chewing Gum Tablets [0069] In an embodiment of the invention, the compressed chewing gum tablet is one wherein the first compressed module is on top of a second compressed module. FIGS. 1 a and 1 b illustrates such a compressed chewing gum tablet according to the invention. The illustrated chewing gum tablet 10 comprises two chewing gum modules 11 and 12 . [0070] According to the illustrated embodiment, each module is simply comprised by a layer. The multi-module tablet may in this embodiment be regarded as a two-layer or two-module chewing gum tablet 10 . The two modules 11 and 12 are adhered to each other. Different processes may be applied for the purpose as described below. However, according to a preferred embodiment of the invention, the mutual adhering between the two modules is obtained by the compression of one module 11 onto the other module 12 . [0071] The illustrated chewing gum tablet 10 may for example comprise a non-gum base-containing module 11 and a gum base-containing module 12 . Thus, in an embodiment of the invention, the compressed chewing gum tablet in one wherein the second compressed module, i.e. the module 11 , comprises compressed tablet material. Examples of useful tablet material are described below. [0072] However, it may under some circumstances be useful also to include gum base in the second compressed module. Thus, in a useful embodiment, the second compressed module, i.e. the module 11 , comprises compressed chewing gum particles containing gum base and optionally one or more further chewing gum ingredients. [0073] FIG. 2 a illustrates a cross-section of a compressed chewing gum tablet according to the invention and FIG. 2 b illustrates the chewing gum from above. Thus, an embodiment of the present invention is one wherein the first compressed module is on top of a second compressed module on top of a third compressed module, or described in another manner, the first module is located between two outer modules. [0074] The illustrated chewing gum tablet 20 in FIG. 2 a may in one embodiment comprises a three-module chewing gum of which the lowest module or third module 23 comprises compressed tablet material, and the modules 21 and 22 are as described above in FIG. 1 . In a further embodiment, the compressed chewing gum tablet 20 is one wherein the third compressed module 23 comprises compressed chewing gum particles containing gum base and optionally one or more further chewing gum ingredients. The modules 21 and 22 may be as described above in FIG. 1 . [0075] However, under some circumstances it may be useful to provide a chewing gum tablet having three modules comprising compressed chewing gum particles containing gum base. Thus, in a useful embodiment, the compressed chewing gum tablet is one wherein said first, second and/or third compressed module comprises compressed chewing gum particles containing gum base and one or more further chewing gum ingredients. [0076] An interesting embodiment of the invention is where the chewing gum tablet 20 comprises three modules, wherein the first compressed module 22 comprises compressed chewing gum particles containing gum base and one or more further chewing gum ingredients, and where said module is located between two compressed outer modules 21 and 23 comprising compressed tablet material. [0077] FIG. 3 a illustrates a cross-section of a compressed chewing gum tablet 30 according the invention and illustrated in FIG. 3 b from above. The illustrated chewing gum tablet 30 comprises a module 32 comprising compressed chewing gum particles containing gum base and optionally one or more further chewing gum ingredients upon which a second module 31 is arranged. The module 31 may comprise compressed tablet material or compressed chewing gum particles containing gum base and one or more further chewing gum ingredients. [0078] FIG. 4 a illustrates a cross-section of a further compressed multi-modular chewing gum tablet 40 according to the invention and illustrated in FIG. 4 b from above. The tablet 40 differs somewhat from the other described tablets in the sense that the tablet comprises a module 42 comprising compressed chewing gum particles containing gum base and optionally one or more further chewing gum ingredients forming a gum centre. The module 42 is encapsulated by a surrounding module 41 . The module 41 may comprise compressed tablet material or compressed chewing gum particles containing gum base and one or more further chewing gum ingredients. [0079] FIG. 5 a illustrates a cross-section of a compressed multi-modular chewing gum tablet 50 according to the invention and illustrated in FIG. 5 b from above. According to the illustrated embodiment, showing a ring-formed two-module tablet 50 , a module 52 comprising compressed chewing gum particles containing gum base a certain concentration and optionally one or more further chewing gum ingredients, whereas the other module 51 comprises compressed tablet material. [0080] Alternatively, the chewing gum module 51 may comprise a content of compressed chewing gum particles containing gum base differing from that of the content of module 52 , thereby facilitating a chewing gum providing at least two different release profiles in one piece. [0081] The compressed chewing gum tablet of the present invention comprises an active compound according to formula I as well as a taste-masking agent. An advantage of the compressed chewing gum tablet according the present invention is that the compound according to formula I is released faster than from conventionally mixed chewing gum. An additional advantage is that the specific location of the compound according to formula I and the taste-masking agent provides for a co-release of the compound according to formula I and the taste-masking agent. In this context, the “co-release” means that when the compound according to formula I is released from the chewing gum during chewing, some taste-masking agent is also released. A preferred embodiment of the invention is one, when the compound according to formula I is released from the chewing gum during chewing, an amount of taste-masking agent sufficient to mask the bitter taste of the compound according to formula I is also released. Active Compound According to Formula I Between the Particles [0082] In a preferred embodiment, the chewing gum of the present invention, is one wherein the compound according to formula I and the taste-masking agent are located between the compressed chewing gum particles containing gum base of the first compressed module, and/or, if a second compressed module is present, between the compressed chewing gum particles containing gum base of the second compressed module. In a useful embodiment, the compound according to formula I and the taste-masking agent are located in the compressed chewing gum particles containing gum base of the first and/or second compressed module. [0083] Without being bound by theory, the inventors suggest that the effective masking effect results from a quick release and/or co-release of the taste-masking agent in the chewing gum. This is achieved by placing the compound according to formula I together or in direct contact with the taste-masking agent so that both compounds releases simultaneously. Compound According to Formula I Located in Different Compressed Modules [0084] A quick release of the taste-masking agent and/or co-release of the taste-masking agent and the compound according to formula I in the chewing gum may also be obtained by placing the agent and the compound together or separate in different compressed modules of the chewing gum according to the invention. [0085] Thus, in a useful embodiment, the chewing gum of the present invention is one comprising a first and a second compressed module, wherein the first compressed module comprises compressed chewing gum particles containing gum base, an active compound according to formula I, and a taste-masking agent. [0086] It is well known for a skilled person in the art to prepare a chewing gum with multiple compressed modules. In accordance with invention, the second compressed module may preferable not comprise gum base, or only comprise at most 1% gum base, such as at the most 0.5% gum base by weight of the second compressed module. [0087] In a further preferred embodiment, the compressed chewing gum tablet is one comprising a first and a second compressed module, wherein the first compressed module comprises compressed chewing gum particles containing gum base, and an active compound according to formula I, and the second compressed module comprises a taste-masking agent. [0088] In an even further preferred embodiment, the compressed chewing gum tablet is one comprising a first and a second compressed module, wherein the first compressed module comprises compressed chewing gum particles containing gum base, and a taste-masking agent, and the second compressed module comprises an active compound according to formula I. [0089] A quick release of the taste-masking agent and/or co-release of the taste-masking agent and the compound according to formula I in the chewing gum may also be obtained by placing the two compounds together in a different compressed module of the chewing gum than the module comprising compressed chewing gum particles containing gum base. [0090] Thus, in a still further preferred embodiment, the compressed chewing gum tablet is one comprising a first and a second compressed module, wherein the first compressed module comprises compressed chewing gum particles containing gum base, and the second compressed module comprises an active compound according to formula I and a taste-masking agent. [0091] In an embodiment, the compressed chewing gum tablet comprises a first, a second and a third compressed module, wherein the first compressed module comprises compressed chewing gum particles containing gum base, and the second compressed module may comprise an active compound according to formula I and the third compressed module may comprise a taste-masking agent. In a further embodiment, the compressed chewing gum tablet is one, wherein the first compressed module comprises further a taste-masking agent and the compressed modules comprising compressed tablet material comprises an active compound according to formula I. [0092] In accordance with the invention, the compound according to formula I and the taste-masking agent are compressed together with the chewing gum particles containing gum base. However, this process is described in detail below. [0093] Although it is under some circumstances preferred that the second compressed module not comprises gum base, or only comprise at most 1% gum base, such as at the most 0.5% gum base by weight of the second compressed module, it may be useful to incorporate compressed chewing gum particles containing gum base in the second module of the chewing gum. Ratio Between Active Compound According to Formula I and Taste-Masking Agent [0094] In accordance with the present invention, the ratio between the active compound according to formula I and the taste-masking agent is well-balanced as it is presently believed that a specifically defined ratio is one of the reasons for providing a good taste and palatability of the present compressed chewing gum tablet. [0095] In a preferred embodiment, the weight ratio between the taste-masking agent and the compound according to formula I is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0096] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent and the compound according to formula I is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1, such as in the range of 50:1-150:1. [0097] In a further preferred embodiment, the weight ratio between the taste-masking agent of the first compressed module and the compound according to formula I of the first compressed module is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0098] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent of the first compressed module and the compound according to formula I of the first compressed module is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1 such as in the range of 50:1-150:1. [0099] In another preferred embodiment, the weight ratio between the taste-masking agent of the second compressed module and the compound according to formula I of the first compressed module is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0100] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent of the second compressed module and the compound according to formula I of the first compressed module is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1, such as in the range of 50:1-150:1. [0101] In another preferred embodiment, the weight ratio between the taste-masking agent and of the first compressed module and the compound according to formula I of the second compressed module is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0102] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent of the first compressed module and the compound according to formula I of the second compressed module is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1, such as in the range of 50:1-150:1. [0103] In a further preferred embodiment, the weight ratio between the taste-masking agent of the second compressed module and the compound according to formula I of the second compressed module and is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0104] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent of the second compressed module and the compound according to formula I of the second compressed module is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1, such as in the range of 50:1-150:1. [0105] In a preferred embodiment, the chewing gum tablet comprising a first, second and third module, the weight ratio between the taste-masking agent of the third compressed module and the compound according to formula I of the second compressed module is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0106] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent of the third compressed module and the compound according to formula I of the second compressed module is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1, such as in the range of 50:1-150:1. [0107] In another preferred embodiment, the weight ratio between the taste-masking agent of the first compressed module and the compound according to formula I of the modules comprising tablet material and is at least 5:1, preferably at least 10:1, such as at least 20:1, and even more preferred at least 50:1, such as at least 100:1. [0108] In a useful embodiment, the chewing gum is one wherein the weight ratio between the taste-masking agent of the first compressed module and the compound according to formula I of the modules comprising tablet material is in the range of 5:1-500:1, preferably in the range of 10:1-250:1, such as in the range of 20:1-200:1, and even more preferred in the range of 40:1-175:1, such as in the range of 50:1-150:1. The Chewing Gum Particles Containing Gum Base [0109] The gum base contained in the compressed modules of the chewing gum tablet according to the invention is typically present in the form of compressed gum base particles. The manufacturing of gum base particles is described below. However, the particles may be manufactured according to conventional methods or e.g. those described in the EP1474993, EP1474994 and EP1474995, hereby incorporated by reference. [0110] It was found, that by using compressed particles of gum base in combination with a specifically defined ratio between the active compound according to formula I and the taste-masking agent, as described above, results in an acceptable texture and an interesting taste experience as well as an effective masking of the bitter taste of the active compound. [0111] In accordance with the invention, the chewing gum particles comprise gum base. As described above, the chewing gum particles may have any form of chewing gum particles containing a certain amount of gum base. The content of gum base in the particles may vary. In some embodiments, the amount of gum base in the chewing gum particles is rather high, such in the range of 40-99% by weight of the chewing gum particles. In some embodiments, the amount of gum base in the chewing gum particles is in the range of 40-90% by weight of the chewing gum particles, such as in the range of 40-80% by weight, including in the range of 40-70% by weight, e.g. in the range of 40-50% by weight, such as in the range of 50-85% by weight, including in the range of 50-75% by weight, e.g. in the range of 50-55% by weight of the chewing gum particles. [0112] In some other embodiments, the amount of gum base in the chewing gum particles is lower, such as in the range of 15-60% by weight of the chewing gum particles. Other useful amounts may vary in the range of 20-60% by weight of the chewing gum particles, such as in the range of 20-50%, including in the range of 20-40% by weight, e.g. in the range of 30-55% by weight, such as in the range of 30-45% by weight of the chewing gum particles. The remaining content of the chewing gum particles may comprise one or more of the below described chewing gum ingredients. [0113] In some embodiments, the particles are made entirely of gum base, substantially without conventional chewing gum ingredients. In this case, the chewing gum ingredients may be applied in the compression process, such as by adding the chewing gum ingredients together with the gum base particles for compression. [0114] In some other embodiments, the particles are made of chewing gum, substantially without further needs for chewing gum ingredients in the compression process. Of course, intermediate solutions may be applicable, such as a varying amount of chewing gum ingredients in the chewing gum particles or in the compression process. [0115] It may be preferred to apply at least a certain amount of high intensity sweetener and/or flavour and/or colour to the chewing gum particles in some embodiments of the invention, such as in case the chewing gum particles substantially consist of gum base. [0116] In preferred embodiments, the average particle size of the particles is in the range of 50-2000 micrometer measured as the longest dimension of the particle, preferably in the range of 100-1500 micrometer, and even more preferred in the range of 200-1300 micrometer. [0117] In even more preferred embodiments, the chewing gum tablet is one wherein at least 70% of the particles have a particle size in the range of 50-2000 micrometer measured as the longest dimension of the particle, preferably in the range of 100-1500 micrometer, and even more preferred in the range of 200-1300 micrometer. Gum Base [0118] In a preferred embodiment, the chewing gum composition comprises a gum base. Typically, a useful gum base compositions typically comprise one or more elastomeric compounds which may be of synthetic or natural origin, one or more resinous compounds which may be of synthetic or natural origin, fillers, softening compounds and minor amounts of miscellaneous ingredients such as antioxidants and colorants, etc. One advantage of the present invention is that there is no need to adjust the content of other chewing gum ingredients in order to maintain the desired texture. Furthermore, a very interesting observation is that no disintegration of the chewing gum occurs upon chewing. [0119] The compressed module containing gum base according to the invention may typically be made on the basis of gum base particles. The gum base particles are made on the basis of a gum base. In addition to the above definition of the expression “gum base”, the expression further refers to the water-insoluble part of the chewing gum tablet which typically constitutes 10 to 99% by weight including the range of 20-99% by weight of the total chewing gum composition, such as the range of 30-99% by weight of the total chewing gum composition. In preferred embodiments, the chewing gum composition comprises gum base in the range of 10-80% by weight of the chewing gum composition, preferably in the range 20-70% by weight, and even more preferably in the range 30-60% by weight of the chewing gum composition. [0120] The chewing gum base, which is admixed with chewing gum ingredients as defined below, can vary substantially depending on the particular product to be prepared and on the desired masticatory and other sensory characteristics of the final product. However, typical ranges (weight %) of the above gum base components are: 5 to 50% by weight elastomeric compounds, 5 to 55% by weight elastomer plasticizers, 0 to 50% by weight filler/texturiser, 5 to 35% by weight softener and 0 to 1% by weight of miscellaneous ingredients such as antioxidants, colorants, etc. [0121] In a preferred embodiment, the gum base may comprise an elastomer. Natural elastomers may include natural rubber such as smoked or liquid latex and guayule as well as natural gums such as jelutong, lechi caspi, massaranduba balata, sorva, perillo, rosindinha, massaranduba chocolate, chicle, nispero, gutta hang kang, and combinations thereof. Useful synthetic elastomers include, but are not limited to, synthetic elastomers listed in U.S. Food and Drug Administration, CFR, Title 21, Section 172,615, the Masticatory Substances, Synthetic, the contents of which are incorporated herein by reference for all purposes) such as polyisobutylene. e.g. having an average molecular weight in the range of about 10,000 to 1,000,000 including the range of 50,000 to 80,000, isobutylene-isoprene copolymer (butyl elastomer), styrene-butadiene copolymers e.g. having styrene-butadiene ratios of about 1:3 to 3:1, polyvinyl acetate (PVA), e.g. having a average molecular weight in the range of 2,000 to 90,000 such as the range of 3,000 to 80,000 including the range of 30,000 to 50,000, where the higher molecular weight polyvinyl acetates are typically used in bubble gum base, polyisoprene, polyethylene, vinyl acetate-vinyl laurate copolymer e.g. having a vinyl laurate content of about 5 to 50% by weight such as 10 to 45% by weight of the copolymer and combinations hereof. [0122] It is possible to combine a synthetic elastomer having a high molecular weight and a synthetic elastomer having a low molecular weight elastomer in a gum base. Presently preferred combinations of synthetic elastomers include, but are not limited to, polyisobutylene and styrene-butadiene, polyisobutylene and polyisoprene, polyisobutylene and isobutylene-isoprene copolymer (butyl rubber) and a combination of polyisobutylene, styrene-butadiene copolymer and isobutylene isoprene copolymer, and all of the above individual synthetic polymers in admixture with polyvinyl acetate, vinyl acetate-vinyl laurate copolymers, respectively and mixtures thereof. [0123] Typically, the gum base comprises at least one elastomer in an amount in the range of 3-80% by weight of the gum base, preferably in an amount in the range of 4-60% by weight of the gum base, and even more preferred in the range of 5-40% by weight of the gum base, such as in the range of 8-20% by weight of the gum base. [0124] Particularly interesting elastomeric or resinous polymer compounds which advantageously can be used in accordance with the present invention include polymers which, in contrast to currently used elastomers and resins, can be degraded physically, chemically or enzymatically in the environment after use of the chewing gum, thereby giving rise to less environmental pollution than chewing gums based on non-degradable polymers, as the used degradable chewing gum remnants will eventually disintegrate and/or can be removed more readily by physical or chemical means from the site where it has been dumped. [0125] In preferred embodiments, the gum base of the chewing gum tablet may comprise one or more resins contributing to obtain the desired masticatory properties and acting as plasticizers for the elastomers of the gum base. The resin may be a natural resin and/or it may be a synthetic resin. In the present context, useful resins include, but are not limited to, natural rosin esters, often referred to as ester gums including as examples glycerol esters of partially hydrogenated rosins, glycerol esters of polymerised rosins, glycerol esters of partially dimerised rosins, glycerol esters of tally oil rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins and pentaerythritol esters of rosins. Other useful resinous compounds include synthetic resins such as terpene resins derived from alpha-pinene, beta-pinene, and/or d-limonene, natural terpene resins; and any suitable combinations of the foregoing. The choice of resins will vary depending on the specific application, and on the type of elastomer(s) being used. [0126] Usually, the gum base comprises at least one resin in an amount in the range of 10-90% by weight of the gum base, preferably in the range of 20-80% by weight, even more preferred in the range of 30-70% by weight of the gum base, such as in the range of 40-60% by weight of the gum base. In preferred embodiments, the gum base comprises at least one resin in the range of 3-80% by weight of the gum base, preferably in an amount in the range of 4-60% by weight of the gum base, and even more preferred in the range of 5-40% by weight of the gum base, such as in the range of 8-20% by weight of the gum base. [0127] The gum base may furthermore comprise one or more softener. According to the present text, the term “softener” may be used interchangeably with plasticizers and plasticizing agents, and is used for ingredients, which softens the gum or chewing gum formulation and encompass wax, fat, oil, emulsifiers, surfactants, solubilizers etc. The softeners may also include sucrose polyesters, such as glycerin, lecithin, and combinations thereof. Aqueous sweetener solutions such as those containing sorbitol, hydrogenated starch hydrolysates, corn syrup and combinations thereof, may also be used as softeners and binding agents in the chewing gum according to the invention. [0128] In a preferred embodiment, the gum base comprises an emulsifier, which aid in dispersing any immiscible components into a single stable system. The emulsifiers useful in this invention include glyceryl monostearate, lecithin, fatty acid monoglycerides, diglycerides, propylene glycol monostearate, and the like, and mixtures thereof. The emulsifier may be employed in an amount in the range of 1-15% by weight of the gum base, and preferably in the range 5-10% by weight of the gum base. [0129] Further examples of useful emulsifier include anionic, cationic, amphoteric or non-ionic emulsifiers can be used. Suitable emulsifiers include lecithins, polyoxyethylene stearate, polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of edible fatty acids, saccharose esters of fatty acids, polyglycerol esters of fatty acids, polyglycerol esters of interesterified castor oil acid (E476), sodium stearoyllatylate, sodium lauryl sulfate and sorbitan esters of fatty acids and polyoxyethylated hydrogenated castor oil (e.g. the product sold under the trade name CREMOPHOR), block copolymers of ethylene oxide and propylene oxide (e.g. products sold under trade names PLURONIC and POLOXAMER), polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters of fatty acids and polyoxyethylene steraric acid esters. [0130] Particularly suitable emulsifiers are polyoxyethylene stearates, such as for instance polyoxyethylene (8) stearate and polyoxyethylene (40) stearate, the polyoxyethylene sorbitan fatty acid esters sold under the trade name TWEEN, for instance TWEEN 20 (monolaurate), TWEEN 80 (monooleate), TWEEN 40 (monopalmitate), TWEEN 60 (monostearate) or TWEEN 65 (tristearate), mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of edible fatty acids, sodium stearoyllactylate, sodium laurylsulfate, polyoxyethylated hydrogenated castor oil, block copolymers of ethylene oxide and propyleneoxide and polyoxyethylene fatty alcohol ether. The emulsifiers may either be a single compound or a combination of several compounds. [0131] Some emulsifier also referred to as plasticizers, to provide a variety of desirable textures and consistency properties. Because of the low molecular weight of these components, the plasticizers are able to penetrate the fundamental structure of the gum base making it plastic and less viscous. Useful plasticizers include lanolin, palmitic acid, oleic acid, stearic acid, sodium stearate, potassium stearate, glyceryl triacetate, glyceryl lecithin, glyceryl monostearate, propylene glycol monostearate, acetylated monoglyceride, glycerine, and the like, and mixtures thereof. [0132] In preferred embodiments, the softener used in the gum base of the chewing gum of the invention is a fat. The fat may e.g. include partially or fully hydrogenated vegetable or animal fats, such as partially or fully hydrogenated coconut oil, partially or fully hydrogenated palm oil, partially or fully hydrogenated palm kernel oil, partially or fully hydrogenated rapeseed oil, partially or fully hydrogenated castor oil, partially or fully hydrogenated maize oil, partially or fully hydrogenated cottonseed oil, partially or fully hydrogenated olive oil, partially or fully hydrogenated sunflower oil, partially or fully hydrogenated safflower oil, partially or fully hydrogenated sesame oil, partially or fully hydrogenated soybean oil, partially or fully hydrogenated beef tallow, and partially or fully hydrogenated lard, and any mixture thereof and any derivative thereof. In useful embodiments, the gum base comprises a fat in an amount in the range of 1-15% by weight of the gum base, and preferably in the range 5-10% by weight of the gum base. [0133] The gum base may furthermore comprise a wax. When a wax is present in the gum base, it softens the polymeric elastomer mixture and improves the elasticity of the gum base. The waxes employed will have a melting point below about 60° C., and preferably between about 45° C. and about 55° C. The low melting wax may be a paraffin wax. The wax may be present in the gum base in an amount from about 6% to about 10%, and preferably from about 7% to about 9.5% by weight of the gum base. [0134] In addition to the low melting point waxes, waxes having a higher melting point may be used in the gum base in amounts up to about 5%, by weight of the gum base. Such high melting waxes include beeswax, vegetable wax, candelilla wax, canauba wax, most petroleum waxes, and the like, and mixtures thereof. [0135] Further useful waxes include natural and synthetic waxes, hydrogenated vegetable oils, petroleum waxes such as polyurethane waxes, polyethylene waxes, paraffin waxes, microcrystalline waxes, fatty waxes, sorbitan monostearate, tallow, propylene glycol, mixtures thereof, and the like, may also be incorporated into the gum base. [0136] Anhydrous glycerin may also be employed as a softening agent, such as the commercially available United States Pharmacopeia (USP) grade. Glycerin is a syrupy liquid with a sweet warm taste and has a sweetness of about 60% of that of cane sugar. Because glycerin is hygroscopic, the anhydrous glycerin may be maintained under anhydrous conditions throughout the preparation of the chewing gum composition. [0137] In an embodiment of the invention, the gum base comprises at least one resin in an amount in the range of 10-90% by weight of the gum base, at least one elastomer in an amount in the range of 4-60% by weight of the gum base, and an emulsifier in an amount in the range of 1-15% by weight. Preferably, the gum base comprises at least one resin in an amount in the range of 30-70% by weight of the gum base, at least one elastomer in an amount in the range of 5-40% by weight of the gum base, and an emulsifier in an amount in the range of 5-10% by weight of the gum base. [0138] In a preferred embodiment, the gum base of the chewing gum according to the invention comprises a filler. The fillers/texturizers may include magnesium and calcium carbonate, sodium sulphate, ground limestone, silicate types such as magnesium and aluminium silicate, kaolin, clay, aluminium oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, and combinations thereof. [0139] The fillers/texturizers may also include natural organic fibres such as fruit vegetable fibres, grain, rice, cellulose and combinations thereof. Chewing Gum Ingredients [0140] In accordance with the present invention the chewing gum tablet comprises one or more further chewing gum ingredients. Such a chewing gum ingredient may be selected from the group consisting least a bulk sweetener, a high intensity sweetener, a flavouring agent, a cooling agent, a warming agent, a colouring agent, a binding agent, a pH regulating agent and an active ingredient. [0141] In a useful embodiment of the present invention, the at least one chewing gum ingredient is a bulk sweetener. The bulk sweetener may be selected from the group consisting of monosaccharides, disaccharides, polysaccharides, sugar alcohols, and mixtures thereof; randomly bonded glucose polymers such as those polymers distributed under the tradename POLYDEXTROSE by Pfizer, Inc., Groton, Conn.; isomalt (a racemic mixture of alpha-D-glucopyranosyl-1,6-mannitol and alpha-D-glucopyranosyl-1,6-sorbitol manufactured under the tradename PALATINIT by Süddeutsche Zucker), maltodextrins; hydrogenated starch hydrolysates; hydrogenated hexoses; and hydrogenated disaccharides. [0142] Furthermore, the bulk sweetener may be selected from the group consisting of dextrose, sucrose, lactose, xylitol, mannitol, sorbitol, mannitol, maltitol, isomaltol or isomalt, erythritol, lactitol, and cyclodextrin. [0143] In an especially preferred embodiment of the invention, the bulk sweetener is present in amount ranging from 10-70% by weight of the chewing gum composition. [0144] The bulk sweetener may be present in amount ranging from 30-70% by weight of the chewing gum composition, such as e.g. in the range 35-65% by weight of the chewing gum composition, and in the range 40-60% by weight of the chewing gum composition. For example, the bulk sweetener may be present in amount ranging from 20-55% by weight of the chewing gum composition, such as e.g. in amount ranging from 30-50% by weight of the chewing gum composition. [0145] In interesting embodiment, the chewing gum composition according to the invention further comprises a high intensity sweetener. Useful high intensity sweetener may be selected from the group consisting of sucralose, neotame, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones e.g. NHDC, thaumatin, monellin, stevioside, Twinsweet (aspartame-acesulfame salt) and combinations thereof. [0146] In order to provide longer lasting sweetness and flavour perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweetener. Likewise, encapsulation may be applied for the purpose of stabilizing the ingredients. Techniques such as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, coascervation, encapsulation in yeast cells and fiber extrusion may be used to achieve the desired release characteristics. Encapsulation of sweetening agents can also be provided e.g. using another chewing gum component, such as a resinous compound, as the encapsulation agent. [0147] Usage level of the artificial sweetener will vary considerably depending e.g. on factors such as potency of the sweetener, rate of release, desired sweetness of the product, level and type of flavour used and cost considerations. Thus, the active level of artificial sweetener may vary from about 0.02 to 8% by weight. When carriers used for encapsulation are included, the usage level of the encapsulated sweetener will be proportionally higher. Combinations of sugar and/or non-sugar sweeteners can be used in the chewing gum formulation processed in accordance with the invention. Additionally, the softener may also provide additional sweetness such as with aqueous sugar or alditol solutions. [0148] If a low calorie chewing gum tablet is desired, a low calorie bulking agent can be used. Examples of low calorie bulking agents include polydextrose, Raftilose, Raftilin, Inuline, fructooligosaccharides (NutraFlora®), palatinose oligosaccharided; guar gum hydrolysates (e.g. Sun Fiber®) or indigestible dextrins (e.g. Fibersol®). However, other low calorie-bulking agents can be used. [0149] Flavouring agents may also be useful for the organoleptic properties in the chewing gum composition according to the invention. The flavouring agents which may be used include those flavouring agents known to the skilled artisan, such as natural and artificial flavouring agents. These flavouring agents may be chosen from synthetic flavour oils and flavouring aromatics and/or oils, oleoresins and extracts derived from plants, leaves, flowers, fruits, and so forth, and combinations thereof. Non-limiting representative flavour oils include spearmint oil, cinnamon oil, oil of wintergreen (methyl salicylate), peppermint oil, clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, allspice, oil of sage, mace, oil of bitter almonds, and cassia oil. Also useful flavouring agents are artificial, natural and synthetic fruit flavours such as vanilla, and citrus oils including lemon, orange, lime, grapefruit, and fruit essences including apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot and so forth. These flavouring agents may be used in liquid or solid form and may be used individually or in admixture. Commonly used flavouring agents include mints such as peppermint, menthol, spearmint, artificial vanilla, cinnamon derivatives, and various fruit flavouring agents, whether employed individually or in admixture. [0150] Other useful flavouring agents include aldehydes and esters such as cinnamyl acetate, cinnamaldehyde, citral diethylacetal, dihydrocarvyl acetate, eugenyl formate, p-methylamisol, and so forth may be used. Generally any flavouring agent or food additive such as those described in Chemicals Used in Food Processing, publication 1274, pages 63-258, by the National Academy of Sciences, may be used. This publication is incorporated herein by reference. [0151] Further examples of aldehyde flavouring agents include, but are not limited to, acetaldehyde (apple), benzaldehyde (cherry, almond), anisic aldehyde (licorice, anise), cinnamic aldehyde (cinnamon), citral, i.e., alpha-citral (lemon, lime), neral, i.e., beta-citral (lemon, lime), decanal (orange, lemon), ethyl vanillin (vanilla, cream), heliotrope, i.e., piperonal (vanilla, cream), vanillin (vanilla, cream), alpha-amyl cinnamaldehyde (spicy fruity flavours), butyraldehyde (butter, cheese), valeraldehyde (butter, cheese), citronellal (modifies, many types), decanal (citrus fruits), aldehyde C-8 (citrus fruits), aldehyde C-9 (citrus fruits), aldehyde C-12 (citrus fruits), 2-ethyl butyraldehyde (berry fruits), hexenal, i.e., trans-2 (berry fruits), tolyl aldehyde (cherry, almond), veratraldehyde (vanilla), 2,6-dimethyl-5-heptenal, i.e., melonal (melon), 2,6-dimethyloctanal (green fruit), and 2-dodecenal (citrus, mandarin), cherry, grape, strawberry shortcake, and mixtures thereof. [0152] In some embodiments, the flavouring agent may be employed in either liquid form and/or dried form. When employed in the latter form, suitable drying means such as spray drying the oil may be used. Alternatively, the flavouring agent may be absorbed onto water soluble materials, such as cellulose, starch, sugar, maltodextrin, gum arabic and so forth or may be encapsulated. The actual techniques for preparing such dried forms are well-known. [0153] In some embodiments, the flavouring agents may be used in many distinct physical forms well-known in the art to provide an initial burst of flavour and/or a prolonged sensation of flavour. Without being limited thereto, such physical forms include free forms, such as spray dried, powdered, beaded forms, encapsulated forms, and mixtures thereof. [0154] The amount of flavouring agent employed herein may be a matter of preference subject to such factors as the type of final chewing gum, the individual flavour, the gum base employed, and the strength of flavour desired. Thus, the amount of flavouring may be varied in order to obtain the result desired in the final product and such variations are within the capabilities of those skilled in the art without the need for undue experimentation. In chewing gum compositions, the flavouring agent is generally present in amounts from about 0.02% to about 5% by weight, and more specifically from about 0.1% to about 2% by weight, and even more specifically, from about 0.8% to about 1.8%, by weight of the chewing gum composition. [0155] According to the invention, encapsulated flavours may be added to the final blend prior to compression. Different methods of encapsulating flavours mixed into the gum base and flavours compressed into the chewing gum may e.g. include spray drying, spray cooling, film coating, coascervation, double emulsion method (extrusion technology) or prilling. Materials to be used for the above-mentioned encapsulation methods may e.g. include gelatine, wheat protein, soya protein, sodium caseinate, caseine, gum arabic, modified starch, hydrolyzed starches (maltodextrines), alginates, pectin, carregeenan, xanthan gum, locus bean gum, chitosan, bees wax, candelilla wax, carnauba wax, hydrogenated vegetable oils, zein and/or sucrose. [0156] Useful cooling agents are mentioned in U.S. Pat. No. 6,627,233, the contents of which are incorporated herein by reference for all purposes. Particular examples of cooling agents include: menthol, xylitol, menthane, menthone, menthyl acetate, menthyl salicylate, N,2,3-trimethyl-2-isopropyl butanamide (WS-23), substituted p-menthanes, substituted p-menthane-carboxamides (e.g., N-ethyl-p-menthane-3-carboxamide (FEMA 3455)), acyclic carboxamides, substituted cyclohexanamides, substituted cyclohexane carboxamides, substituted ureas and sulphonamides, and substituted menthanols (all from Wilkinson Sword); hydroxymethyl and hydroxyethyl derivatives of p-menthane (from Lever Bros.); menthyl succinate; 2-mercapto-cyclo-decanone (from International Flavors and Fragrances); 2-isopropanyl-5-methylcyclohexanol (from Hisamitsu Pharmaceuticals, hereinafter “isopregol”); hydroxycarboxylic acids with 2-6 carbon atoms; menthone glycerol ketals (FEMA 3807, tradename FRESCOLAT™ type MGA); 3-I-menthoxypropane-1,2-diol (from Takasago, FEMA 3784, (hereinafter “TCA”)); menthyl lactate; (from Haarman & Reimer, FEMA 3748, tradename FRESCOLAT™ type ML). These and other suitable cooling agents are further described in the following U.S. patents, all of which are incorporated in their entirety by reference hereto: U.S. Pat. Nos. 4,230,688 and 4,032,661 to Rowsell et al.; 4,459,425 to Amano et al.; 4,136,163 to Watson et al.; and 5,266,592 to Grub et al. The cooling agents are typically present in amounts of about 0.001 to about 10% by weight of the chewing gum composition. [0157] Useful warming agents may be selected from a wide variety of compounds known to provide the sensory signal of warming to the user. These compounds offer the perceived sensation of warmth, particularly in the oral cavity, and often enhance the perception of flavours, sweeteners and other organoleptic components. Among the useful warming compounds included are vanillyl alcohol n-butylether (TK-1000) supplied by Takasago Perfumary Company Limited, Tokyo, Japan, vanillyl alcohol n-propylether, vanillyl alcohol isopropylether, vanillyl alcohol isobutylether, vanillyl alcohol n-aminoether, vanillyl alcohol isoamyleather, vanillyl alcohol n-hexyleather, vanillyl alcohol methylether, vanillyl alcohol ethyleather, gingerol, shogaol, paradol, zingerone, capsaicin, dihydrocapsaicin, nordihydrocapsaicin, homocapsaicin, homodihydrocapsaicin, ethanol, isopropol alcohol, iso-amylalcohol, benzyl alcohol, glycerine, and combinations thereof. Furthermore, useful warming agents include capsicum and nicotinate esters, such as benzyl nicotinate. [0158] Whiteners and colouring agents may be used in amounts effective to produce the desired colour. The colouring agents may include pigments which may be incorporated in amounts up to about 6%, by weight of the chewing gum composition. For example, titanium dioxide may be incorporated in amounts up to about 2%, and preferably less than about 1%, by weight of the chewing gum composition. The colourants may also include natural food colours and dyes suitable for food, drug and cosmetic applications. These colourants are known as F.D.& C. dyes and lakes. The materials acceptable for the foregoing uses are preferably water-soluble. Illustrative nonlimiting examples include the indigoid dye known as F.D.& C. Blue No. 2, which is the disodium salt of 5,5-indigotindisulfonic acid. Similarly, the dye known as F.D.& C. Green No. 1 comprises a triphenylmethane dye and is the monosodium salt of 4-[4-(N-ethyl-p-sulfoniumbenzylamino) diphenylmethylene]-[1-(N-ethyl-N-p-sulfoniumbenzyl)-delta-2,5-cyclohexadieneimine]. A full recitation of all F.D.&C. colourants and their corresponding chemical structures may be found in the Kirk-Othmer Encyclopedia of Chemical Technology, 3rd Edition, in volume 5 at pages 857-884, which text is incorporated herein by reference. [0159] Useful pH-regulating agents, acidity regulators, or pH control agents are additives which may be added to the chewing gum to change or maintain pH (acidic, alkaline or pH neutral). They can be organic or mineral acids (acidulants), bases, neutralizing agents, or buffering agents. Examples of useful compounds include ascorbic acid, fumaric acid, adipic acid, lactic acid, malic acid, citric acid, tartaric acid, propionic acid, phosphoric acid and combinations thereof. [0160] Compression adjuvants may also be added. These compounds facilitate compression of the gum into tablets. Suitable compression adjuvants include, but are limited to, glidants, lubricants, wetting agents, diluents, humectants. More specifically, useful compression adjuvants include silicon dioxide, magnesium stearate, calcium stearate, behenic acid, talc and similar substances which can be used to limit the tendency of the gum tablets to stick to the presses. [0161] The above mentioned chewing gum ingredients may be pre-mixed into the gum base or be added to a portion of the chewing gum comprising no or a low amount of gum base. [0162] In an embodiment of the invention, the chewing gum comprises a center filling. Furthermore, the chewing gum tablet may be processed into in a number of different shapes such as a stick, a core, a tablet, a slab, a bead, a pellet, a tape, or a ball. Alkalizing Agent [0163] Preliminary experiments (not shown here) have indicated that compressed chewing gum tablets according to the present invention gain improved stability by the presence of one or more alkalizing agent. Thus, in a preferred embodiment of the invention, the compressed chewing gum tablet furthermore comprises one or more alkalizing agent(s). [0164] In the context of the present invention, the term “alkalizing agent” covers any compounds which are able to increase the pH of deionized water when added to it. [0165] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises an alkali or alkaline-earth metal hydroxide. [0166] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises a carbonate salt. [0167] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises a bicarbonate salt. [0168] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises a phosphate salt. [0169] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises a borate salt. [0170] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises a basic salt of an organic acid. [0171] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises a basic salt of a carboxylic acid or of a hydroxy carboxylic acid. An example of this is e.g. a basic salt of a food acid. Examples of useful alkalizing agents are a basic salt of ascorbic acid, a basic salt of fumaric acid, a basic salt of adipic acid, a basic salt of lactic acid, a basic salt of malic acid, a basic salt of citric acid, a basic salt of tartaric acid, a basic salt of propionic acid, or combinations thereof. [0172] In an embodiment of the invention, at least one of the one or more alkalizing agent(s) comprises tri-sodium citrate. [0173] The one or more alkalizing agent(s) may be located different places in the tablet. In an embodiment of the invention, the first compressed module comprises the one or more alkalizing agent(s). [0174] In a preferred embodiment of the invention, the second compressed module comprises the one or more alkalizing agent(s). [0175] In yet an embodiment of the invention, the first and second compressed modules comprise the one or more alkalizing agent(s), i.e. the one or more alkalizing agent may be present both in first and the second compressed module at the same time. [0176] The stability effect provided by the alkalizing agent appears to be particularly predominant when the one or more alkalizing agent(s) is/are present in the tablet an amount sufficient to yield a pH within a specific range as mentioned below when the tablet is submerged and partially dissolved in water. [0177] Thus, in a preferred embodiment of the invention, the one or more alkalizing agent(s) is/are present in the tablet an amount sufficient to form a pH in the range of pH 5-12, preferably in the range of pH 5.5-11, and even more preferably in the range of pH 6-10, such as in the range of pH 6.5-9, or in the range of pH 7-9, wherein the formed pH is determined by submerging the compressed chewing gum tablet chewing gum tablet in 50 mL deionized water, stirring the mixture of the tablet and deionized water for 30 minutes, and then immediately measuring the pH of the mixture, and wherein the temperature of the mixture is maintained at approx. 25 degrees C. during the stirring and the measurement. [0179] In embodiments where the tablet comprises a water-insoluble coating, the pH determination is performed using the uncoated tablet. [0180] In another embodiment of the invention, the one or more alkalizing agent(s) is/are present in the second compressed module in an amount sufficient to form a pH in the range of pH 5-12, preferably in the range of pH 5.5-11, and even more preferably in the range of pH 6-10, such as in the range of pH 6.5-9, or in the range of pH 7-9, wherein the formed pH is determined by submerging the second compressed module in 50 mL deionized water, stirring the mixture of the second compressed module and deionized water for 30 minutes, and then immediately measuring the pH of the mixture, and wherein the temperature of the mixture is maintained at approx. 25 degrees C. during the stirring and the measurement. [0182] The amount of the one or more alkalizing agent(s) varies with the selection of the active compound according to formula I and the other excipients of the tablet. In an embodiment of the invention, the compressed chewing gum tablet comprises the one or more alkalizing agent(s) in an amount in the range of 0.01-25% by weight of the tablet, preferably in the range of 0.1-10% by weight of the tablet, and even more preferred in the range of 0.25-5% by weight of the tablet. [0183] In yet an embodiment of the invention, the first compressed layer comprises the one or more alkalizing agent(s) in an amount in the range of 0.01-25% by weight of the first compressed layer, preferably in the range of 0.1-10% by weight of the first compressed layer, and even more preferred in the range of 0.25-5% by weight of the first compressed layer. [0184] In preferred embodiment of the invention, the second compressed layer comprises the one or more alkalizing agent(s) in an amount in the range of 0.01-25% by weight of the second compressed layer, preferably in the range of 0.1-10% by weight of the second compressed layer, and even more preferred in the range of 0.25-5% by weight of the second compressed layer. [0185] While the one or more alkalizing agent(s) may be present in the tablet in many different forms, it is presently preferred that at least one of the one or more alkalizing agents(s) is in particulate form. [0186] In another embodiment of the invention, at least one of the one or more alkalizing agents(s) is in intimate contact with the active compound according to formula I. Intimate contact may e.g. be accomplished by granulated the at least one of the one or more alkalizing agents(s) with the active compound according to formula I. Alternatively it may be accomplished by pre-blending the at least one of the one or more alkalizing agents(s) with the active compound according to formula I with the active compound according to formula I before the preparing the powder mixture for compression. Pre-blending is particularly effective if the average particle size of the alkalizing agent is substantially smaller than the particle size of the particles comprising the active compound according to formula I. Tablet Material [0187] In accordance with the present invention, the second and/or third compressed module of the chewing gum may comprise tablet material. The expression “tablet material” is in the present context used for the above described chewing gum ingredients when these are used in a compressed module comprising tablet material. However, examples of further useful tablet materials include, but are not limited to, conventional pharmaceutical acceptable excipients such as a glidant, a lubricant, a filler substance, and a dry or wet binder. [0188] Examples of useful glidants and lubricants are stearic acid, metallic stearates, talc, colloidal silica, sodium stearyl fumarate and alkyl sulphates. [0189] In the present invention, a dry binder such as e.g. sorbitol, isomalt, or mixtures thereof may be used. The dry binder provides the effect of binding a material and thereby providing a powder that can be compressed into a tablet. [0190] A wet binder is an excipient that in combination with water facilitates a powder to be compressed into tablets. A wet binder must, at least to some extent, be soluble in water. Examples of wet binders are PVP (polyvinylpyrrolidone), HPMC (hydroxymethylpropylcellulose) or gelatine. [0191] A filler substance may be any pharmaceutically acceptable substance that does not interact with the active compound according to formula I or with other excipients. Useful filler substances include sorbitol, mannitol, dextrins, maltodextrins, inositol, erythritol, isomalt, lactitol, maltitol, mannitol, xylitol, low-substituted hydroxypropylcellulose, starches or modified starches (e.g. potato starch, maize starch, rice starch, pre-gelatinised starch), polyvinylpyrrolidone, polyvinylpyrrolidone/vinyl acetate copolymer, agar (e.g. sodium alginate), carboxyalkylcellulose, dextrates, gelatine, gummi arabicum, hydroxypropyl cellulose, hydroxypropylmethylcellulose, methylcellulose, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysaccharides e.g. dextran, soy polysaccharide, sodium carbonate, and sodium chloride. Coating [0192] In accordance with the invention, the chewing gum tablet may comprise a coating applied onto the chewing gum center. In the present context, a suitable coating is any coating that results in extended storage stability of the compressed chewing gum products as defined above, relative to a chewing gum of the same composition that is not coated. Thus, suitable coating types include hard coatings, soft coatings, film coatings and sealing coatings of any composition including those currently used in coating of chewing gum, pharmaceutical products and confectioneries. The chewing gum tablet comprises the coating in an amount in the range of 1-80% by weight of the chewing gum, such as in an amount in the range of 10-50%, or 15-45% by weight of the chewing gum. Preferably, the chewing gum tablet comprises the coating in an amount in the range of 20-40% by weight of the chewing gum tablet. [0193] In a useful embodiment of the invention, the coating comprises an active compound according to formula I. The coating may e.g. comprise an active compound according to formula I in an amount in the range of 1-30 mg, and preferably in the range of 5-20 mg. Preferably, the coating comprises an active compound according to formula I an amount in the range of 1-10% by weight of the coating. [0194] The coating may be a hard coating, which term is used in the conventional meaning of that term including sugar coatings and sugar-free (or sugarless) coatings and combinations thereof. The objects of hard coating are to obtain a sweet, crunchy layer, which is appreciated by the consumer, and to protect the composition for various reasons. In a typical process of providing the composition with a protective sugar coating the gum centers are successively treated in suitable coating equipment with aqueous solutions of crystallizable sugar such as sucrose or dextrose, which, depending on the stage of coating reached, may contain other functional ingredients, e.g. fillers, colours, etc. In the present context, the sugar coating may contain further functional or active compounds including flavour compounds, pharmaceutically active compounds and/or polymer degrading substances. [0195] In the production of chewing gums it may, however, be preferred to replace the cariogenic sugar compounds in the coating by other, preferably crystallizable, sweetening compounds that do not have a cariogenic effect. In the art such coating is generally referred to as sugarless or sugar-free coatings. Presently preferred non-cariogenic hard coating substances include polyols, e.g. sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol, isomalt and tagatose which are obtained by industrial methods by hydrogenation of D-glucose, maltose, fructose or levulose, xylose, erythrose, lactose, isomaltulose and D-galactose, respectively. One advantage of using polyols in the coating is that they act simultaneously as a sweetener and as a taste-masking agent for the bitter taste of an active compound according to formula I. [0196] In a typical hard coating process, a syrup containing crystallizable sugar and/or polyol is applied onto the chewing gum tablet and the water it contains is evaporated off by blowing with warm, dry air. This cycle may be repeated several times, typically 10 to 80 times, in order to reach the swelling required. The term “swelling” refers to the increase in weight of the products, as considered at the end of the coating operation by comparison with the beginning, and in relation to the final weight of the chewing gum. [0197] Alternatively, the coating may be a soft coating. Such a soft coating is applied using conventional methods and may advantageously consist of a composition of a sugar or any of the above non-cariogenic, sugar-less sweetening compounds and a starch hydrolysate. [0198] In a preferred embodiment of the invention, the chewing gum tablet comprises a film coating. The film coating may be obtained by subjecting the composition to a film coating process and which therefore comprises one or more film-forming polymeric agents and optionally one or more auxiliary compounds, e.g. plasticizers, pigments and opacifiers. A film coating is a thin polymer-based coating applied to a composition of any of the above forms. The thickness of such a film coating is usually between 20 and 100 micrometer. Generally, the film coating is obtained by passing the composition through a spray zone with atomized droplets of the coating materials in a suitable aqueous or organic solvent vehicle, after which the material adhering to the composition is dried before the next module of coating is received. This cycle is repeated until the coating is complete. [0199] In the present context, suitable film-coating polymers include edible cellulose derivatives such as cellulose ethers including methylcellulose (MC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC) and hydroxypropyl methylcellulose (HPMC). Other useful film-coating agents are acrylic polymers and copolymers, e.g. methylacrylate aminoester copolymer or mixtures of cellulose derivatives and acrylic polymers. Useful polymers may include: cellulose acetate phtalate (CAP), polyvinyl acetate phtalate (PVAP), shellac, metacrylic acid copolymers, cellulose acetate trimellitate (CAT) and HPMC. It will be appreciated that the outer film coating according to the present invention may comprise any combination of the above film-coating polymers. [0200] In other embodiments of the invention, the film-coating layer of the chewing gum tablet comprise a plasticizing agent having the capacity to alter the physical properties of a polymer to render it more useful in performing its function as a film forming material. In general, the effect of plasticizers will be to make the polymer softer and more pliable as the plasticizer molecules interpose themselves between the individual polymer strands thus breaking down polymer-polymer interactions. Most plasticizers used in film coating are either amorphous or have very little crystallinity. [0201] In the present context, suitable plasticizers include polyols such as glycerol, propylene glycol, polyethylene glycol, e.g. the 200-6000 grades hereof, organic esters such as phtalate esters, dibutyl sebacate, citrate esters and triacetin, oils/glycerides including castor oil, acetylated monoglycerides and fractionated coconut oil. [0202] The choice of film-forming polymer (s) and plasticizing agent (s) for the film coating of the composition is made with due consideration for achieving the best possible barrier properties of the coating in respect of dissolution and diffusion across the film of moisture and gasses. [0203] The film coating of the chewing gum tablet may also contain one or more colorants or opacifiers. In addition to providing a desired colour hue, such agents may contribute to protecting the compressed gum base against pre-chewing reactions, in particular by forming a barrier against moisture and gasses. Suitable colorants/opacifiers include organic dyes and their lakes, inorganic colouring agents, e.g. titanium oxide and natural colours such as e.g. beta-carotene. [0204] Additionally, film coatings may contain one or several auxiliary substances such as flavours and waxes or saccharide compounds such as polydextrose, dextrins including maltodextrin, lactose, modified starch, a protein such as gelatine or zein, a vegetable gum and any combination thereof. [0205] A sealing coating of e.g. shellac, ethyl cellulose, zein, acrylic compounds or carnauba wax or the like may be applied over the hard coating, if desired, in order to seal the crunchy coating to reduce the exposure of the coating to atmospheric moisture. [0206] The coating, in general, typically comprises one or more layers. For example the number of layers of the coating may be in the range of 1-100 layers, such as 3-75 layers, 10-60 layers, and 20-40 layers. [0207] The coating comprises for example comprise a wax layer. In an embodiment of the invention, the outermost layer of the coating is a wax layer. [0208] A compressed chewing gum tablet according to the present invention, has typically a weight in the range of 0.1-10 g, such as in the range of 0.5-5 g or in the range of 0.75-2.5 g, preferably in the range of 0.8-2 g, and even more preferred in the range of 1-1.5 g. Furthermore, the chewing gum tablet has a weight in the range of 0.5-3.0 g, such as in the range of 0.75-2.5 g or in the range of 0.8-2.0 g, preferably in the range of 1.0-1.5 g. Center-filled chewing gums normally have weights in the range of 0.5-5 g, preferably in the range of 1-4 g, and even more preferred in the range of 2-3 g. Typical weights for bead shaped chewing gums are in the range of 0.1-0.6 g, preferably in the range of 0.2-0.5 g, and even more preferred in the range of 0.3-0.4 g. [0209] Yet an aspect of the invention relates to an oral dosage form identical to the compressed chewing gum tablet as defined herein, but with the one exception that all gum base has been replaced with an inert excipient, such as polyol sweetener. All aspects and embodiments mentioned herein, except for details relating to the gum base, also apply to the oral dosage form. [0210] The oral dosage form may be in the form of a capsule; a tablet, and particularly an effervescent tablet or a fast disintegrating tablet; a liquid syrup; a dry syrup; a lozenge; or a hardboiled confectionery. In a preferred embodiment of the invention, the oral dosage form is in the form of a tablet. [0211] It should be understood that any embodiments and/or feature discussed above in connection with the compressed chewing gum tablet according to the invention apply by analogy to the below aspects of the present invention. Method of Preparing a Compressed Chewing Gum Tablet [0212] In further aspects there are provided methods for preparing a compressed chewing gum tablet having multiple compressed modules. Initially, chewing gum particles containing gum base are provided. Useful particles may be manufactured according to conventional methods or e.g. those described in the EP 1 474 993, EP 1 474 994 and EP 1 474 995, hereby incorporated by reference. [0213] The chewing gum particles may be in any suitable form according to the invention. As described above, in some embodiments, the particles have been particulated prior to application. Particulation may be in any form of “building up” particles from smaller primary particles into macro particles or in any form of “building down” from larger substances into macro particles. Any form of particulation may be applied, such as granulation, pelletizing, agglomeration, or any other suitable means for particulation. [0214] Granulation may be applied in some embodiments as a means for particulation, resulting in granules. Granules should be understood in its broadest content. In some embodiments of the invention, the granules may be a result of a total chewing gum manufacture, where the chewing gum after production is comminuted into smaller particles, optionally under cooling conditions such as with a coolant or physical cooling, where after these particles are pressed together, optionally using at least some further processing aids. The comminuted particles may be achieved by grinding, milling, or any other suitable processing means. [0215] Thus, in a specific embodiment the chewing gum particles are provided by a method where the particles are obtained through grinding of the prepared chewing gum composition. More specifically, such a method comprises the steps of a) mixing of a soft basic gum base with at least one sweetener and, optionally, at least one other chewing gum ingredient, at a temperature of between 35 and 75° C.; b) cooling of the mixture thus obtained to a temperature of between 0 and −40° C. and, preferably, between −10 and −40° C.; c) grinding and subsequent screening of the mixture thus obtained to a particle size of less than 10 mesh; and d) optional mixing of the powder thus obtained with at least one anti-agglutination agent. [0216] Agglomeration may also be applied in some other embodiments as a means for participation, resulting in agglomerates. [0217] Pelletizing may be applied in some other embodiments as a means for particulation, resulting in pellets. The pellets may be partly manufactured as a result of an extruding process. In some embodiments, the pellets are pelletized in an underwater process, whereby gum base are pressed through dies in a die plate, meaning openings of a certain diameter, into a cooling media and thereupon dried. In some other embodiments, the pellets are pelletized in a strand pelletizing process with cool air. [0218] Thus, in a specific embodiment, the chewing gum particles containing gum base are provided by a method comprising at least the steps of a) feeding a gum base into an extruder; b) pressurizing the gum base in the extruder; c) extruding the gum base through a die means; and d) cutting the extruded gum base in a liquid filled chamber. [0219] In useful embodiments, the provided chewing gum particles are made entirely of a [0000] gum base, substantially without conventional chewing gum ingredients. In this case, the chewing gum ingredients may be applied in the compression process, such as by adding the chewing gum ingredients together with the gum base particles for compression. [0220] However, under some circumstances it may be useful to provide chewing gum particles made entirely of a chewing gum composition, substantially without further needs for chewing gum ingredients in the compression process. [0221] Chewing gum ingredients, e.g. flavours and sweeteners, may with advantage be added to the gum base in order to obtain a gum base composition in the extruder immediately before the composition is extruded through the die means into the water filled chamber where the extruded and cut chewing gum composition is immediately cooled to low temperatures. [0222] Of course, intermediate solutions may be applicable, such as a varying amount of chewing gum ingredients in the chewing gum particles or in the compression process. It may be preferred to apply at least a certain amount of high intensity sweetener and/or flavour and/or colour to the chewing gum particles in some embodiments of the invention, such as in case the chewing gum particles substantially consist of gum base. [0223] By adding the chewing gum ingredients to the chewing gum particles, the ingredients are only subjected to elevated temperatures during the extrusion, such as only during the latter part thereof, and the short duration of the extrusion and the quick cooling in the water prevents or reduces decomposition of fragile flavours components, and thus preserving a maximum of the components. This is especially important for natural flavours in order to maintain the full natural taste of the flavour. [0224] In accordance with the present invention, the chewing gum tablet is a compressed chewing gum tablet. The compression is preferably performed by applying pressure to the mixture of chewing gum particles, ingredients etc., whereby the bulk volume is reduced and the amount of air is decreased. During this process energy is consumed. As the components of the mixture come into closer proximity to each other during the volume reduction process, bonds may be established between the components. The formation of bonds is associated with a reduction in the energy of the system as energy is released. Volume reduction takes place by various mechanisms and different types of bonds may be established between the components depending on the pressure applied and the properties of the components. [0225] In one aspect of the present invention, there is provided a method of preparing a compressed chewing gum tablet, comprising one compressed module, the method comprising the steps of: a) providing a portion comprising an active compound according to formula I, a portion comprising taste-masking agent, and chewing gum particles containing gum base; b) optionally providing one or more further chewing gum ingredients; c) dosing the portion comprising the compound according to formula I, the portion comprising taste-masking agent, and the chewing gum particles containing gum base, and optionally the one or more further chewing gum ingredients; and d) compressing a) and b) after dosing, to obtain a first compressed module. [0226] Thus, the compressed chewing gum tablet is prepared by providing a portion comprising the compound according to formula I, a portion comprising taste-masking agent, and chewing gum particles containing gum base. Subsequent, the portions are individually dosed, i.e. the portions are individually loaded in the table machine, and compressed together under high pressure (typically when applying cooling) into a first compressed module. Any tablet pressing machine may be used which is capable of pressing tablets comprising particles containing chewing gum base. [0227] In accordance with the present invention, one or more chewing gum ingredients may, as described above, may be provided and compressed together in step d) with the portion comprising the compound according to formula I, the portion comprising taste-masking agent and the chewing gum particles containing gum base. However, the one and more chewing gum ingredients may also be added to the gum base in the extruder as described above. [0228] In a further aspect of the present invention, the method comprising the steps of a) providing a portion comprising an active compound according to formula I, a portion comprising taste-masking agent, and chewing gum particles containing gum base; b) optionally providing one or more further chewing gum ingredients; c) mixing the portion comprising the compound according to formula I, the portion comprising taste-masking agent, and the chewing gum particles containing gum base, and optionally the one or more further chewing gum ingredients, thus obtaining a mixture, and d) compressing the mixture, to obtain a first compressed module. Thus, the portions of the chewing gum components are mixed before the loading of the tablet machine. [0229] In a useful embodiment, the methods according to the invention furthermore comprise a step of coating the first compressed module with the above mentioned coatings. [0230] In an embodiment, the above methods furthermore comprises the steps of e) providing a portion comprising tablet material; f) contacting the first compressed module with the portion of step e), i.e. the tablet material; and g) compressing the portion of e) and the first compressed module to obtain a coherent compressed chewing gum tablet comprising a first and a second compressed module. A further step of the present methods comprises a step of coating the coherent compressed chewing gum tablet of step g). [0231] Useful tablet materials are mentioned above. Furthermore, the method comprises a step of coating the coherent compressed chewing gum tablet. [0232] A further aspect relates to a method of preparing a compressed chewing gum tablet according to the invention comprising two compressed modules, the method comprising the steps of a) providing chewing gum particles containing gum base and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising an active compound according to formula I and a portion comprising a taste-masking agent; c) compressing a) to obtain a first compressed module; d) contacting the first compressed module with b); and e) compressing b) and the first compressed module to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module. It will be understood, that the portion comprising an active compound according to formula I and the portion comprising a taste-masking agent may be dosed individually or mixed together before dosed in the tablet machine. [0233] A further step of the present method comprises a step of coating the coherent compressed chewing gum tablet of step e). [0234] In a useful embodiment, chewing gum particles containing gum base and optionally one or more chewing gum ingredients are further provided in step b), and subsequent compressed to obtain a second compressed module prior to contacting the first portion. [0235] In an interesting embodiment, a tablet material is further provided in step b). [0236] In a still further aspect, there is provided a method of preparing a compressed chewing gum tablet according to the invention comprising two compressed modules, the method comprising the steps of a) providing chewing gum particles containing gum base and a portion comprising an active compound according to formula I, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising taste-masking agent; c) compressing a) to obtain a first compressed module; d) contacting the first compressed module with b); e) compressing b) and the first compressed module, to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module. It will be understood, that the portion comprising an active compound according to formula I and chewing gum particles comprising gum base may be dosed individually or mixed together before dosed in the tablet machine. [0237] A further step of the present method according comprises a step of coating the coherent compressed chewing gum tablet of step e). [0238] In a useful embodiment, chewing gum particles containing gum base and optionally one or more chewing gum ingredients are further provided in step b), and subsequent compressed to obtain a second compressed module prior to contacting the first portion. [0239] In an interesting embodiment, a tablet material is further provided in step b). [0240] In a further aspect of the present invention, there is provided a method of preparing a compressed chewing gum tablet according to the invention comprising three compressed modules, the method comprising the steps of a) providing chewing gum particles containing gum base, a portion comprising a taste-masking agent, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising tablet material and optionally a portion comprising an active compound according to formula I; c) providing a portion comprising tablet material and a portion comprising an active compound according to formula I; d) locating b) and c) on opposite sites of a) following a sequence of one or more compressing step(s), to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module and a third compressed module. It will be understood, that the portion comprising a taste-masking agent and the chewing gum particles containing gum base may be dosed individually or mixed together before dosed in the tablet machine. [0241] In a useful embodiment, the method according to the invention furthermore comprises a step of coating the coherent compressed chewing gum tablet of step d). [0242] A still further aspect relates to a method of preparing a compressed chewing gum tablet according to the invention comprising three compressed modules, the method comprising the steps of a) providing chewing gum particles containing gum base, a portion comprising an active compound according to formula I, and optionally portion(s) comprising one or more chewing gum ingredients, b) providing a portion comprising tablet material and optionally a portion comprising a taste-masking agent, c) providing a portion comprising tablet material and a portion comprising a taste-masking agent, d) locating b) and c) on opposite sites of a) following a sequence of one or more compressing step(s), to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module and a third compressed module. [0243] In a useful embodiment, the method according to the invention furthermore comprises a step of coating the coherent compressed chewing gum tablet of step d). [0244] A final aspect relates to a method of preparing a compressed chewing gum tablet according to the invention comprising three compressed modules, the method comprising the steps of a) providing chewing gum particles containing gum base, and optionally portion(s) comprising one or more chewing gum ingredients; b) providing a portion comprising tablet material and a portion comprising an active compound according to formula I and a portion comprising a taste-masking agent; c) providing a portion comprising tablet material and a portion comprising an active compound according to formula I and a portion comprising a taste-masking agent; and d) locating b) and c) on opposite sites of a) following a sequence of one or more compressing step(s), to obtain a coherent compressed chewing gum tablet comprising a first compressed module and a second compressed module and a third compressed module. It will be understood, that the a portion comprising an active compound according to formula I and the portion comprising a taste-masking agent may be dosed individually or mixed together before dosed in the tablet machine. [0245] The following examples are included to demonstrate particular embodiments of the invention. However, those of skill in the art should, in view of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention. The following examples are offered by way of illustration and are not intended to limit the invention in any way. EXAMPLES Example 1 Compressed Chewing Gum Tablet Having One Compressed Module [0246] 24 specific chewing gum tablets comprising cetirizine, a polyol (taste-masking agent) and chewing gum particles containing gum base are prepared. Table 1.1 shows the location of the cetirizine and the taste-masking agent in the different chewing gum type A-F, and Table 1.2 show the concentration of cetirizine (i.e. 5 mg and 10 mg) and taste-masking agent (i.e. 250 mg and 500 mg) in the chewing gum type A-F. [0247] The chewing gum in the following example is manufactured from a commercially available gum base (Danfree, available from Gumlink A/S, Vejle, Denmark) supplemented with about 15% by weight elastomer, about 20% by weight natural resin, about 20% by weight PVA, about 20% by weight filler, about 5% emulsifier, and about 20% by weight fat. Such mixture is in the following referred to as the “gum base” [0000] Cetirizine and/or Polyol Between the Chewing Gum Particles Containing Gum Base [0248] The gum base is feed to an extruder (Leistrits ZSE/BL 360 kw 104, available from GALA GmbH, Germany) and flavour is added and mixed with gum base in the extruder. The resulting gum base composition is extruded to a granulator comprising a die plate and liquid filled chamber (A5 PAC 6, available from GALA GmbH, Germany) connected to a water system comprising water supply for the granulator and centrifugal dryer (TWS 20, available from GALA GmbH, Germany). The granulator produces chewing gum particles containing gum base. The preparation of chewing gum particles is described in details in EP1474993, EP147994 and EP147995. [0249] The chewing gum particles containing gum base are subsequently mixed with cetirizine, taste-masking agent and/or other chewing gum ingredients in order to obtain chewing gum tablet type D, E and F. [0000] Cetirizine and/or Polyol in the Chewing Gum Particles Containing Gum Base [0250] Method I: The gum base is feed to an extruder (Leistrits ZSE/BL 360 kw 104, available from GALA GmbH, Germany) and cetirizine, polyol and/or flavour are added and mixed to the gum base in the extruder. The resulting chewing gum composition is extruded to a granulator comprising a die plate and liquid filled chamber (A5 PAC 6, available from GALA GmbH, Germany) [0251] Method II: Cetirizine and/or polyol may also be incorporated into the particles by adding them during the manufacturing of the gum base. Cetirizine and/or polyol are added during the mixing of the gum base ingredients preferably at the end of mixing. The gum base can subsequent be particulated by extrusion, pelletizing, milling, grinding or any other methods Compression [0252] Before pressing, the mixture is passed through a standard horizontal vibration sieve removing particles larger than 2.6 mm. The mixture is subsequently passed to a standard tablet pressing machine comprising dosing apparatus (e.g. P 3200 C, available from Fette GmbH, Germany) and pressed into compressed chewing gum tablets having one compressed module. The filling depth is approximately 7.5 mm and the diameter 7.0 mm. The tablets are pre-compressed to 5.0 mm and then main compressed to 3.2 mm using a pressing pressure of 33.0-33.6 kN. There are 61 punches on the rotor, and the rotor speed used is 11 rpm. The individual compressed tablets have a weight of approx. 1.5 g. [0000] TABLE 1.1 Location of cetirizine and polyol in compressed chewing gum tablet types A-F Chewing gum Cetirizine location Polyol location A In the particles In the particles B In the particles Between the particles C In the particles Both in the particles and between the particles D Between the particles In the particles E Between the particles Between the particles F Between the particles Both in the particles and between the particles [0000] TABLE 1.2 Concentration of cetirizine and polyol in compressed chewing gums types A-F No Chewing Conc. Cetirizine Conc. Polyol 1 A 5 250 2 A 5 500 3 A 10 250 4 A 10 500 5 B 5 250 6 B 5 500 7 B 10 250 8 B 10 500 9 C 5 250 10 C 5 500 11 C 10 250 12 C 10 500 13 D 5 250 14 D 5 500 15 D 10 250 16 D 10 500 17 E 5 250 18 E 5 500 19 E 10 250 20 E 10 500 21 F 5 250 22 F 5 500 23 F 10 250 24 F 10 500 Example 2 Compressed Chewing Gum Tablet Having Two Compressed Modules [0253] A number of compressed chewing gum tablets having two compressed modules comprising cetirizine and polyol (taste-masking agent) are prepared. Tables 2.1, 2.3, 2.5 and 2.7 show the location of the cetirizine and polyol in the different chewing gum type G-R, S-DD, EE-NN and OO-WW, respectively, and Tables 2.2, 2.4, 2.6 and 2.8 show the concentration of cetirizine (i.e. 5 or 10 mg) and polyol (i.e. 250 or 500 mg) in the chewing gum type G-R, S-DD, EE-NN and OO-WW, respectively. [0254] The chewing gum particles containing gum base are prepared as described above in Example 1. The manufacturing of cetirizine and/or polyol in or between the chewing gum particles containing gum base is also performed as described in Example 1. Two chewing gum mixtures I and II are prepared comprising each cetirizine, polyol and other chewing gum ingredients. As outlines in below tables 2.1, 2.3, 2.5 and 2.7, within these mixture the cetirizine and polyol may be located either in or between the chewing gum particles containing gum base [0255] Chewing gum mixture I is passed to a standard tablet pressing machine comprising dosing apparatus (e.g. P 3200 C, available from Fette GmbH, Germany) and compressed to form a first compressed module. Subsequent, 2 g of chewing gum mixture II is filed into the tablet pressing machine and compressed onto the first module to form a chewing gum tablet having two compressed modules. However, in some chewing gum tablets (i.e. chewing gum J, N, R, V, Z, DD, HH and OO-WW) tablet material (i.e. gum free module) is used instead of chewing gum particles comprising gum base. Examples of such tablet materials are described above. [0000] TABLE 2.1 Location of cetirizine and a polyol in a two-module compressed chewing gum tablet type G-R, wherein the first module comprises chewing gum particles containing gum base and cetirizine, and the second module comprises chewing gum particles containing gum base a polyol or tablet material and a polyol Chewing gum Cetirizine location Polyol location G In the particles of first Between the particles of the module second module H In the particles of first In the particles of the module second module I In the particles of first Both in and between the module particles of the second module J In the particles of first In a gum free module module K Between the particles of Between the particles of the the first module second module L Between the particles of In the particles of the the first module second module M Between the particles of Both in and between the the first module particles of the second module N Between the particles of In a gum free module the first module O Both in and between the Between the particles of the particles of the first second module module P Both in and between the In the particles of the particles of the first second module module Q Both in and between the Both in and between the particles of the first particles of the second module module R Both in and between the In a gum free module particles of the first module [0000] TABLE 2.2 Concentration of cetirizine and polyol in two-module compressed chewing gum tablet type G-R No. Chewing Conc. cetirizine Conc. polyol 25 G 5 250 26 G 5 500 27 G 10 250 28 G 10 500 29 H 5 250 30 H 5 500 31 H 10 250 32 H 10 500 33 I 5 250 34 I 5 500 35 I 10 250 36 I 10 500 37 J 5 250 38 J 5 500 39 J 10 250 40 J 10 500 41 K 5 250 42 K 5 500 43 K 10 250 44 K 10 500 45 L 5 250 46 L 5 500 47 L 10 250 48 L 10 500 49 M 5 250 50 M 5 500 51 M 10 250 52 M 10 500 53 N 5 250 54 N 5 500 55 N 10 250 56 N 10 500 57 O 5 250 58 O 5 500 59 O 10 250 60 O 10 500 61 P 5 250 62 P 5 500 63 P 10 250 64 P 10 500 65 Q 5 250 66 Q 5 500 67 Q 10 250 68 Q 10 500 69 R 5 250 70 R 5 500 71 R 10 250 72 R 10 500 [0000] TABLE 2.3 Location of cetirizine and a polyol in a two-module compressed chewing gum tablet types S-DD, wherein the first module comprises chewing gum particles containing gum base and a polyol, and the second module comprises chewing gum particles containing gum base and cetirizine or tablet material and cetirizine Chewing gum Cetirizine location Polyol location S Between the particles of In the particles of first the second module module T In the particles of the In the particles of first second module module U Both in and between the In the particles of first particles of the second module module V In a gum free module In the particles of first module W Between the particles of Between the particles of the the second module first module X In the particles of the Between the particles of the second module first module Y Both in and between the Between the particles of the particles of the second first module module Z In a gum free module Between the particles of the first module AA Between the particles of Both in and between the the second module particles of the first module BB In the particles of the Both in and between the second module particles of the first module CC Both in and between the Both in and between the particles of the second particles of the first module module DD In a gum free module Both in and between the particles of the first module [0000] TABLE 2.4 Concentration of cetirizine and polyol in two module compressed chewing gum tablet type S-DD. Chewing Conc. cetirizine Conc. polyol No. gum mg mg 73 S 5 250 74 S 5 500 75 S 10 250 76 S 10 500 77 T 5 250 78 T 5 500 79 T 10 250 80 T 10 500 81 U 5 250 82 U 5 500 83 U 10 250 84 U 10 500 85 V 5 250 86 V 5 500 87 V 10 250 88 V 10 500 89 W 5 250 90 W 5 500 91 W 10 250 92 W 10 500 93 X 5 250 94 X 5 500 95 X 10 250 96 X 10 500 97 Y 5 250 98 Y 5 500 99 Y 10 250 100 Y 10 500 101 Z 5 250 102 Z 5 500 103 Z 10 250 104 Z 10 500 105 AA 5 250 106 AA 5 500 107 AA 10 250 108 AA 10 500 109 BB 5 250 110 BB 5 500 111 BB 10 250 112 BB 10 500 113 CC 5 250 114 CC 5 500 115 CC 10 250 116 CC 10 500 117 DD 5 250 118 DD 5 500 119 DD 10 250 120 DD 10 500 [0000] TABLE 2.5 Location of cetirizine and a polyol in a two-module compressed chewing gum tablet type EE-NN, wherein the first module comprises chewing gum particles containing gum base and the second module comprises chewing gum particles containing gum base, cetirizine and a polyol, or tablet material, cetirizine and a polyol Chewing gum Cetirizine location Polyol location EE Between the particles of the In the particles of second second module module FF In the particles of the second In the particles of second module module GG Both in and between the In the particles of second particles of the second module module HH In a gum free module In a gum free module II Between the particles of the Between the particles of the second module second module JJ In the particles of the second Between the particles of the module second module KK Both in and between the Between the particles of the particles of the second second module module LL Between the particles of the Both in and between the second module particles of the second module MM In the particles of the second Both in and between the module particles of the second module NN Both in and between the Both in and between the particles of the second particles of the second module module [0000] TABLE 2.6 Concentration of cetirizine and polyol in two module compressed chewing gum tablet type EE-NN Chewing Conc. cetirizine Conc. polyol No. gum mg mg 121 EE 5 250 122 EE 5 500 123 EE 10 250 124 EE 10 500 125 FF 5 250 126 FF 5 500 127 FF 10 250 128 FF 10 500 129 GG 5 250 130 GG 5 500 131 GG 10 250 132 GG 10 500 133 HH 5 250 134 HH 5 500 135 HH 10 250 136 HH 10 500 137 II 5 250 138 II 5 500 139 II 10 250 140 II 10 500 141 JJ 5 250 142 JJ 5 500 143 JJ 10 250 144 JJ 10 500 145 KK 5 250 146 KK 5 500 147 KK 10 250 148 KK 10 500 149 LL 5 250 150 LL 5 500 151 LL 10 250 152 LL 10 500 153 MM 5 250 154 MM 5 500 155 MM 10 250 156 MM 10 500 157 NN 5 250 158 NN 5 500 159 NN 10 250 160 NN 10 500 [0000] TABLE 2.7 Location of cetirizine and a polyol in a two-module compressed chewing gum tablet type OO-WW, wherein the first module comprises chewing gum particles containing gum base, cetirizine and a polyol and the second module comprises tablet material Chewing gum Cetirizine location Polyol location OO Between the particles of the In the particles of first first module module PP In the particles of the first In the particles of first module module QQ Both in and between the In the particles of first particles of the first module module RR Between the particles of the Between the particles of the first module first module SS In the particles of the first Between the particles of the module first module TT Both in and between the Between the particles of the particles of the first module first module UU Between the particles of the Both in and between the first module particles of the first module VV In the particles of the first Both in and between the module particles of the first module WW Both in and between the Both in and between the particles of the first module particles of the first module [0000] TABLE 2.8 Concentration of cetirizine and polyol in two-module compressed chewing gum tablet type OO-WW Chewing No. gum Conc. cetirizine Conc. polyol 161 OO 5 250 162 OO 5 500 163 OO 10 250 164 OO 10 500 165 PP 5 250 166 PP 5 500 167 PP 10 250 168 PP 10 500 169 QQ 5 250 170 QQ 5 500 171 QQ 10 250 172 QQ 10 500 173 RR 5 250 174 RR 5 500 175 RR 10 250 176 RR 10 500 177 SS 5 250 178 SS 5 500 179 SS 10 250 180 SS 10 500 181 TT 5 250 182 TT 5 500 183 TT 10 250 184 TT 10 500 185 UU 5 250 186 UU 5 500 187 UU 10 250 188 UU 10 500 189 VV 5 250 190 VV 5 500 191 VV 10 250 192 VV 10 500 193 WW 5 250 194 WW 5 500 195 WW 10 250 196 WW 10 500 Example 3 Compressed Chewing Gum Tablet Having Two Compressed Modules [0256] A compressed chewing gum tablets having two compressed modules comprising cetirizine and polyol (taste-masking agent) was prepared. [0257] The first module (layer) contained [0000] Gum base (with antioxidant BHT = 700 ppm) 400 gram  Isomalt (for direct compression) 527 gram  Twin Sweet  3 gram Grapefruit flavour 60 gram Magnesium stearate 10 gram [0258] The second module (layer) contained [0000] Cetirizine  10 gram Magnesium stearate 0.8 gram Grapefruit flavour 8.0 gram Sorbitol 310.8 gram  Saccharin sodium 0.4 gram [0259] The ingredients for each module were mixed dry in a conventional dry mixer and formed into a tablet in a two station tablet machine as described in Example 1. [0260] The mixtures gave a total of 1000 tablets where each tablet is made op of module 1=1000 mg and module 2=400 mg. The content of Cetirizine is 10 mg per chewing gum piece. If a chewing gum with 5 mg cetirizine is desired, 5 gram of cetirizine is added in the portion for the second module and the sorbitol content is adjusted to 315.8 gram.

1a

RELATED APPLICATIONS This application is the U.S. National Phase under 35 U.S.C. §371 of International Application PCT/US2007/006101, filed Mar. 9, 2007, which application claims the benefit of priority to U.S. Provisional Application Ser. No. 60/780,945, filed Mar. 9, 2006, both of which are herein incorporated by reference in their entirety. FIELD OF THE INVENTION The present invention relates to the field of therapeutic methods and devices for the extracorporeal removal of microvesicular particles, useful, for example, for reversing immune suppression in a subject in need thereof (e.g., a cancer patient) through extracorporeal means. BACKGROUND OF THE INVENTION Immunological control of neoplasia has been a topic of intense investigation dating back to the days of William Coley, who at the beginning of the 20 th century reported potent induction of tumor remission through administration of various non-specific immune stimulatory bacterial extracts which came to be known as “Coley's Toxins” (1). Suggestions of the ability to induce anti-cancer immunological responses also came from experiments in the 1920s demonstrating that the vaccination with non-viable tumor cells mounts a specific “resistance” to secondary challenge, although at the time, the concept of MHC matching was not known and it was possible that the secondary resistance was only a product of allogeneic sensitization (2). Although the field of cancer immunotherapy has been very controversial throughout the 20 th Century, with some authors actually claiming that immunological responses are necessary for tumor growth (3), the age of molecular biology has demonstrated that indeed immune responses are capable of controlling tumors from initiating, as well as in some cases inhibiting the growth of established tumors. Originally demonstrated in the murine system, the concept of a productive anti-tumor response was associated with a cytokine profile termed Th1, whereas an ineffective anti-tumor response was associated with Th2. The prototypic method of assessing Th1 activity was by quantitation of the cytokine IFN-γ (4). At an epigenetic level it is known that the chromatin structure of Th1 and Th2 cells is distinct, thus providing a solid foundation that once a naïve T cell has differentiated into a Th1 or Th2 cell, the silenced and activated parts of the chromatin are passed to progeny cells, thus the phenotype is stable (5). Associated with such chromatin changes is the activation of the multi-gene inducing transcription factors GATA-3 (6), STAT6 (7, 8) in Th2 cells, and T-bet (9), and STAT4 (10) in Th1 cells. Accordingly studies have been performed using STAT6 knockout mice as a model of an immune response lacking Th2 influences, thus predominated by Th1. Tumors administered to STAT6 knockout animals are either spontaneously rejected (11), or immunity to them is achieved with much higher potency compared to wild-type animals (12). Furthermore immunologically mediated increased resistance to metastasis is observed (13). In agreement with the Th1/Th2 balance, mice lacking STAT4 develop accelerated tumors in a chemically-induced carcinogenesis model (14). In the clinical situation correlation between suppressed immune responses and a higher incidence of cancer is well established. For example, natural immune deficiency such as the congenital abnormality Chediak-Higashi Syndrome, in which patients have abnormal natural killer cell function, is associated with an overall weakened immune response. In this population, the overall incidence of malignant tumors is 200-300 times greater than that in the general population (15). In another example, a specific polymorphism of the IL-4 receptor gene that is known to be associated with augmented Th2 responses was investigated in an epidemiological study. Multivariate regression analysis showed that the specific genotype of the IL-4R associated with augmented Th2 activity was an independent prognostic factor for shorter cancer survival and more advanced histopathological grade (16). In addition to inborn genetic abnormalities, the immune suppressive regimens used for post-transplant antirejection effect are associated with a selective inhibition of Th1 responses (17-19). In support of the concept that suppression of Th1 immunity is associated with cancer onset, the incidence of cancer in the post-transplant population is markedly increased in comparison to controls living under similar environmental conditions (20-25). In terms of disease associated immune suppression, HIV infected patients also have a marked predisposition to a variety of tumors, especially, but not limited to lymphomas, as a result of immunodeficiency (26). Although the above examples support a relation between immune suppression (or Th2 deviation) and cancer, the opposite situation, of immune stimulation resulting in anticancer response, is also documented. Numerous clinical trials using antigen specific approaches such as vaccination with either tumor antigens alone (27, 28), tumor antigens bound to immunogens (29, 30), tumor antigens delivered alone (31) or in combination with costimulatory molecules by viral methods (32), tumor antigens loaded on dendritic cells ex vivo (33-35), or administration of in vitro generated tumor-reactive T cells (36), have all demonstrated some clinical effects. Unfortunately, to date, there is no safe, reproducible, and mass-applicable method of therapeutically inducing regression of established tumors, or metastasis via immunotherapy. Approved immunotherapeutic agents such as systemic cytokine administration are associated with serious adverse effects, as well as mediocre responses and applicability to a very limited patient subset. Accordingly, there is a need in the art to develop successful immunotherapy capable of stimulating specific immune responses that only target neoplastic tissue, or components of the host tissue whose activity is necessary for the progression of neoplasia (ie endothelium). The development of such a successful immunotherapy is hindered by suppression of the host immune system by the cancer. Experiments in the 1970s demonstrated the existence of immunological “blocking factors” that antigen-specifically inhibited lymphocyte responses. Some of this early work involved culturing autologous lymphocytes with autologous tumor cells in the presence of third party healthy serum. This culture resulted in an inhibition of growth of the autologous tumor as a result of the lymphocytes. Third party lymphocytes did not inhibit the growth of the tumor. Interestingly when autologous serum was added to the cultures the lymphocyte mediated inhibition of tumor growth was not observed. These experiments gave rise to the concept of antigen-specific “blocking factors” found in the body of cancer patients that incapacitate successful tumor immunity (37-39). More recent demonstration of tumor-suppression of immune function was seen in experiments showing that T cell function is suppressed in terms of inability to secrete interferon gamma due to a cleavage of the critical T cell receptor transduction component, the TCR-zeta chain. Originally, zeta chain cleavage was identified in T cells prone to undergo apoptosis. Although a wide variety of explanations have been put forth for the cleavage of the zeta chain, one particular cause was postulated to be tumor-secreted microvesicles. Microvesicles secreted by tumor cells have been known since the early 1980s. They were estimated to be between 50-200 nanometers in diameter and associated with a variety of immune inhibitory effects. Specifically, it was demonstrated that such microvesicles could not only induce T cell apoptosis, but also block various aspects of T cell signaling, proliferation, cytokine production, and cytotoxicity. Although much interest arose in said microvesicles, little therapeutic applications developed since they were uncharacterized at a molecular level. Research occurring independently identified another type of microvesicular-like structures, which were termed “exosomes”. Originally defined as small (i.e., 80-200 nanometers in diameter), exosomes were observed initially in maturing reticulocytes. Subsequently it was discovered that exosomes are a potent method of dendritic cell communication with other antigen presenting cells. Exosomes secreted by dendritic cells were observed to contain extremely high levels of MHC I, MHC II, costimulatory molecules, and various adhesion molecules. In addition, dendritic cell exosomes contain antigens that said dendritic cell had previously engulfed. The ability of exosomes to act as “mini-antigen presenting cells” has stimulated cancer researchers to pulse dendritic cells with tumor antigens, collect exosomes secreted by the tumor antigen-pulsed dendritic cell, and use these exosomes for immunotherapy. Such exosomes were seen to be capable of eradicating established tumors when administered in various murine models. The ability of dendritic exosomes to potently prime the immune system brought about the question if exosomes may also possess a tolerance inducing or immune suppressive role. Since it is established that the exosome has a high concentration of tumor antigens, the question arose if whether exosomes may induce an abortive T cell activation process leading to anergy. Specifically, it is known that numerous tumor cells express the T cell apoptosis inducing molecule Fas ligand. Fas ligand is an integral type II membrane protein belonging to the TNF family whose expression is observed in a variety of tissues and cells such as activated lymphocytes and the anterior chamber in the eye. Fas ligand induces apoptotic cell death in various types of cells target cells via its corresponding receptor, CD95/APO1. Fas ligand not only plays important roles in the homeostasis of activated lymphocytes, but it has also been implicated in establishing immune-privileged status in the testis and eye, as well as a mechanisms by which tumors escape immune mediated killing. Accordingly, given the expression of Fas ligand on a variety of tumors, we and others have sought, and successful demonstrated that Fas ligand is expressed on exosomes secreted by tumor cells (40). Due to the ability of exosomes to mediate a variety of immunological signals, the model system was proposed that at the beginning of the neoplastic process, tumor secreted exosomes selectively induce antigen-specific T cell apoptosis, through activating the T cell receptor, which in turn upregulates expression of Fas on the T cell, subsequently, the Fas ligand molecule on the exosome induces apoptosis. This process may be occurring by a direct interaction between the tumor exosome and the T cell, or it may be occurring indirectly by tumor exosomes binding dendritic cells, then subsequently when T cells bind dendritic cells in lymphatic areas, the exosome actually is bound by the dendritic cell and uses dendritic cell adhesion/costimulatory molecules to form a stable interaction with the T cell and induce apoptosis. In the context of more advanced cancer patients, where exosomes reach higher concentrations systemically, the induction of T cell apoptosis occurs in an antigen-nonspecific, but Fas ligand, MHC I-dependent manner. The recent recognition that tumor secreted exosomes are identical to the tumor secreted microvesicles described in the 1980s (41), has stimulated a wide variety of research into the immune suppressive ability of said microvesicles. Specifically, immune suppressive microvesicles were identified not only in cancer patients (42, 43), but also in pregnancy (44-46), transplant tolerance (47, 48), and oral tolerance (49, 50) situations. Previous methods of inducing anti-cancer immunity have focused on stimulation of either innate or specific immune responses, however relatively little work has been performed clinically in terms of de-repressing the immune functions of cancer patients. Specifically, a cancer patient having tolerance-inducing exosomes has little chance of mounting a successful anti-tumor immune response. This may be one of the causes for mediocre, if not outright poor, results of current day immunotherapy. Others have attempted to de-repress the immune system of cancer patients using extracorporeal removal of “blocking factors”. Specifically, Lentz in U.S. Pat. No. 4,708,713 describes an extracorporeal method of removing proteins approximately 200 kDa, which are associated with immune suppression. Although Lentz has generated very promising results using this approach, the approach is: a) not-selective for specific inhibitors; b) theoretically would result in loss of immune stimulatory cytokines; c) is not applicable on a wide scale; and d) would have no effect against tumor-secreted microvesicles which are much larger than 200 kDa. The recently discovered properties of microvesicles in general, and tumor microvesicles specifically, have made them a very promising target for extracorporeal removal. Properties such as upregulated expression of MHC I, Fas ligand, increased affinity towards lectins, and modified sphingomyelin content allow for use of extracorporeal devices to achieve their selective removal. Additionally, the size of microvesicles would allow for non-selective removal either alone or as one of a series of steps in selective removal. SUMMARY OF THE INVENTION In accordance with the present invention, there are provided methods of immune stimulation and/or immune de-repression using extracorporeal techniques to remove microvesicles from circulation. In one aspect, the present invention relates to methods of removing microvesicles from the circulation of a subject in need thereof (e.g., cancer patients), thereby de-repressing immune suppression present in said subjects. Accordingly, the present invention teaches the use of various extracorporeal devices and methods of producing extracorporeal devices for use in clearing microvesicle content in subjects in need thereof. Said microvesicles may be elaborated by the tumor itself, or may be generated by non-malignant cells under the influence of tumor soluble or contact dependent interactions. Said microvesicles may be directly suppressing the host immune system through induction of T cell apoptosis, proliferation inhibition, incapacitation, anergy, deviation in cytokine production capability or cleavage of the T cell receptor zeta chain, or alternatively said microvesicles may be indirectly suppressing the immune system through modification of function of other immunological cells such as dendritic cells, NK cells, NKT cells and B cells. Said microvesicles may be suppressing the host antitumor immune response either in an antigen-specific or an antigen-nonspecific manner, or both. One of the objects of the present invention is to provide an effective and relatively benign treatment for cancer. Another object is to provide an adjuvant, and/or neoadjuvant therapy to be used in conjunction with currently used cancer treatments that require a functional immune response for efficacy. Another object is to provide an adjuvant, and/or neoadjuvant therapy to be used in conjunction with currently used cancer treatments that stimulate the immune response of a subject in need thereof in an antigen-specific manner. Another object is to provide an adjuvant, and/or neoadjuvant therapy to be used in conjunction with currently used cancer treatments that stimulate the immune response of a subject in need thereof in an antigen-nonspecific manner. Another object is to provide improvements in extracorporeal treatment of cancer through selecting the novel target of tumor associated microvesicles. Another object is to provide beads or other types of particles that can form a matrix outside of a hollow fiber filter, said matrix component having a size greater than pores of said hollow fiber filter, and said beads or other types of particles being bound to agents that capture microvesicles. Another object is to provide improvements in extracorporeal treatment of cancer through selecting the novel target of tumor associated microvesicles containing unique properties that are not found on microvesicles found in non-cancer patients. Another object is to provide improved specific affinity devices, particularly immunoadsorption devices, and methods useful for removal of cancer associated microvesicles from cancer patients. Specifically, immunoadsorption devices use proteins with affinity to components of the tumor associated microvesicles. Said proteins include antibodies such as antibodies to Fas ligand, MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC II-peptide complexes, or proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient. Contemplated within the invention are proteins that act as ligands for the microvesicular proteins, said proteins may be currently in existence, or may be generated by in silico means based on known qualities of microvesicle-specific proteins. In accordance with one particular aspect of the present invention, methods and devices for treating cancer are provided that are based on the utilization of specific affinity adsorption of microvesicles that are associated with the cancerous state. The affinity adsorbents utilized in accordance with the present invention are both immunoadsorbents and non-immune-based specific affinity chemical adsorbents. More specifically, adsorption can be accomplished based on specific properties of the cancer associated microvesicles, one said property is preferential affinity to lectins and other sugar-binding compounds. In one particular embodiment, the invention provides a device for extracorporeal treatment of blood or a blood fraction such as plasma. This device has a sorbent circulation circuit, which adheres to and retains microvesicles, and a blood circulation circuit through which blood cells flow unimpeded. The device may be constructed in several variations that would be clear to one skilled in the art. Specifically, the device may be constructed as a closed system in a manner that no accumulating reservoir is needed and the sorbent circulation system accumulates the microvesicles, while non-microvesicle matter is allowed to flow back into the blood circulation system and subsequently returned to the patient. Alternatively, the device may use an accumulator reservoir that is attached to the sorbent circulation circuit and connected in such a manner so that waste fluid is discarded, but volume replenishing fluid is inserted back into the blood circulation system so the substantially microvesicle purified blood that is reintroduced to said patient resembles a hematocrit of significant homology to the blood that was extracted from said patient. DETAILED DESCRIPTION OF THE INVENTION For the purposes of advancing and clarifying the principles of the invention disclosed herein, reference will be made to certain embodiments and specific language will be used to describe said embodiments. It will nevertheless be understood and made clear that no limitation of the scope of the invention is thereby intended. The alterations, further modifications and applications of the principles of the invention as described herein serve only as specific embodiment, however one skilled in the art to which the invention relates will understand that the following are indeed only specific embodiments for illustrative purposes, and will derive similar types of applications upon reading and understanding this disclosure. In accordance with one aspect of the present invention, there are provided methods of removing microvesicular particles from a subject in need thereof, said methods comprising: a) establishing an extracorporeal circulation system which comprises contacting the whole blood or components thereof with a single or plurality of agents capable of binding microvesicles found within said blood or components thereof; and b) returning said blood or components thereof into the original blood, said blood or blood components containing substantially less immune suppressive particles in comparison to the blood or blood components originally residing in the blood. Invention methods are useful, for example, for de-repressing immune response, which includes restoration of one or more of the following: T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function. Presently preferred applications of invention methods include restoration of one or more of the following: T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function includes prevention of apoptosis; it is especially preferred that restoration of one or more of the following: T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function includes restoration and/or endowment of activity capable of inhibiting cancer progression. Inhibiting cancer progression as contemplated herein is accomplished in a variety of ways, e.g., by one or more of the following: direct cytolysis of tumor cells, direct induction of tumor cell apoptosis, induction of tumor cell cytolysis through stimulation of intrinsic host antitumor responses, induction of tumor cell apoptosis through stimulation of intrinsic host antitumor responses, inhibition of tumor cell metastasis, inhibition of tumor cell proliferation, and induction of senescence in the tumor cell. Exemplary tumor cells contemplated for treatment herein are selected from the group of cancers consisting of: soft tissue sarcomas, kidney, liver, intestinal, rectal, leukemias, lymphomas, and cancers of the brain, esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate. Agents capable of binding microvesicles contemplated for use herein are selected from the group consisting of one or more of the following: a) a singular or plurality of antibody species; b) a singular or plurality of proteins (e.g., lectins); c) a singular or plurality of aptamers, d) a surface that selectively restricts microvesicles from passage, and e) a surface with selective adhesion to microvesicles. Antibodies contemplated for use herein have a specificity for proteins selected from the group consisting of one or more of the following: Fas ligand, MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC II-peptide complexes, and proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient. Presently preferred antibodies are specific to Fas ligand, MHC I, and the like. Binding proteins contemplated for use herein are selected from the group comprising consisting of one or more of the following: Fas, T cell Receptor, protein extracts isolated from T cells, protein extracts isolated from dendritic cells, and proteins found to possess affinity for binding proteins found on microvesicles associated with immune suppression. Surfaces contemplated for use herein that selectively restrict passage of said microvesicles typically have pore sizes in the range of about 20-400 nanometers in size, with surfaces having pore sized in the range of about 40-300 nanometers in size being preferred, with surfaces having a pore size in the range of about 50-280 nanometers in size being especially preserred. Surfaces with selective adhesion to microvesicles contemplated for use herein can be coated with a single compound, or a plurality of compounds that bind particles that are enriched in sphingomyelin and with a lower level of phosphatidylcholine as found in the cellular membranes of non-malignant cells. In accordance with another aspect of the present invention, agents capable of binding microvesicles are immobilized on a porous hollow fiber membrane. For example, agents capable of binding microvesicles are immobilized on the porous exterior of the hollow fiber membrane. In accordance with another aspect of the present invention, existing methods and devices of extracorporeal treatment of blood can be integrated (in whole or in part) with the above-described methods to augment ex vivo clearance of microvesicles in a physiologically applicable manner. For example, existing methods for extracorporeal treatment of blood can be selected from one or more of the following: a) hemofiltration; b) hemodialysis; and c) hemodiafiltration. A presently preferred existing method for extracorporeal treatment of blood comprises apheresis followed by filtration. In accordance with another embodiment of the present invention, there are provided medical devices useful for the removal of cancer associated microvesicles from the blood of a cancer patient, said device comprising: a) an intake conduit through which blood of a cancer patient in need of treatment enters; b) a single or plurality of matrices capable of adhering to microvesicles causative of cancer associated immune suppression; and c) a system for reintroduction of said blood into the patient in need thereof, whereby said blood is reintroduced under physiologically acceptable conditions. In one aspect of the above-described medical device, the matrices surround a plurality of hollow fiber filters. Preferably, the hollow fiber filters have a diameter of sufficient size to allow passage of blood cells through the lumen, and diffusion of particles between 80-300 nanometers in size. In another aspect fo the above-described medical device, a microvesicle binding agent is chemically reacted with a high-molecular weight substrate and placed on the exterior of said hollow fibers so as to bind non-blood cell liquids permeating through the pores of said hollow fibers. Exemplary microvesicle binding agents include one or more of the following: a) a singular or plurality of antibody species; b) a singular or plurality of proteins (e.g., lectins); c) a singular or plurality of aptamers, d) a surface that selectively restricts microvesicles from passage, and e) a surface with selective adhesion to microvesicles. Exemplary antibodies contemplated for use herein have a specificity for proteins selected from the group consisting of one or more of the following: Fas ligand, MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC II-peptide complexes, and proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient. Presently preferred antibodies are specific to Fas ligand, MHC I, and the like. Exemplary proteins contemplated for use in the invention device are selected from the group consisting of one or more of the following: Fas, T cell Receptor, protein extracts isolated from T cells, protein extracts isolated from dendritic cells, and proteins found to possess affinity for binding proteins found on microvesicles associated with immune suppression. In accordance with another embodiment of the present invention, there are provided methods of potentiating the immunologically mediated anticancer response elicited by vaccination to tumor antigens, said methods comprising: a) immunizing a subject in need thereof using a single or combination of tumor antigens; b) removing immunosuppressive microvesicles from the sera of said subject by extracorporeal means; and c) adjusting the amount of removal of immune suppressive microvesicles based on immune stimulation desired. In accordance with yet another embodiment of the present invention there are provided methods of enhancing the immune response of a subject in need thereof through the removal of microvesicular particles found in systemic circulation of said subject, said methods comprising: a) establishing an extracorporeal circulation system which comprises contacting the whole blood or components thereof with a single or plurality of agents capable of binding microvesicles found within said blood or components thereof; and b) returning said blood or components thereof into the subject, said blood or blood components containing substantially less immune suppressive particles in comparison to the blood or blood components originally residing in said subject. Enhancing immune response as contemplated herein includes one or more of the following: upregulation of T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function. In a presently preferred embodiment, upregulation of one or more of T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function includes prevention of apoptosis. In yet another preferred embodiment, upregulation of one or more of T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function includes enhancing and/or endowment of activity capable of inhibiting cancer progression. Inhibiting cancer progression contemplated herein is accomplished in a variety of ways, e.g., by direct cytolysis of tumor cells, direct induction of tumor cell apoptosis, induction of tumor cell cytolysis through stimulation of intrinsic host antitumor responses, induction of tumor cell apoptosis through stimulation of intrinsic host antitumor responses, inhibition of tumor cell metastasis, inhibition of tumor cell proliferation, and induction of senescence in the tumor cell. Tumor cells contemplated for treatment in accordance with the present invention are selected from the group of cancers consisting of: soft tissue sarcomas, kidney, liver, intestinal, rectal, leukemias, lymphomas, and cancers of the brain, esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate. Agents capable of binding microvesicles contemplated for use herein are selected from the group consisting of one or more of the following: a) a singular or plurality of antibody species; b) a singular or plurality of proteins (e.g., lectins); c) a singular or plurality of aptamers, d) a surface that selectively restricts microvesicles from passage, and e) a surface with selective adhesion to microvesicles. Antibodies having specificity for proteins contemplated for use herein are selected from the group consisting of one or more of the following: Fas ligand, MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC II-peptide complexes, and proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient. Presently preferred antibodies are specific to Fas ligand, MHC I, and the like. Proteins contemplated for use herein are selected from the group consisting of one or more of the following: Fas, T cell Receptor, protein extracts isolated from T cells, protein extracts isolated from dendritic cells, and proteins found to possess affinity for binding proteins found on microvesicles associated with immune suppression. Surfaces that selectively restrict passage of said microvesicles contemplated for use herein typically have a pore size in the range of about 20-400 nanometers in size, with pores sizes in the range of about 40-300 nanometers in size being preferred, and pore sizes in the range of about 50-280 nanometers in size being especially preferred. Surfaces with selective adhesion to microvesicles contemplated for use herein are coated with a variety of agents, e.g., a single compound, or plurality of compounds that bind particles that are enriched in sphingomyelin and with a lower level of phosphatidylcholine as found in the cellular membranes of non-malignant cells. In one aspect, the above-described agents capable of binding microvesicles are immobilized on a porous hollow fiber membrane, e.g., on the porous exterior of the hollow fiber membrane. In another aspect of the invention, existing methods and devices of extracorporeal treatment of blood are integrated (in whole or in part) for augmenting ex vivo clearance of microvesicles in a physiologically applicable manner. Exemplary existing methods for extracorporeal treatment of blood are selected from one or more of the following: a) hemofiltration; b) hemodialysis; and c) hemodiafiltration. A presently preferred existing method for extracorporeal treatment of blood comprises apheresis followed by filtration. In accordance with yet another embodiment of the present invention, there are provided methods of enhancing the immune response of a subject in need thereof through the removal of microvesicular particles found in systemic circulation of said subject, said methods comprising: a) establishing an extracorporeal circulation system which comprises contacting the whole blood or components thereof with a single or plurality of agents capable of binding microvesicles found within said blood or components thereof, said agents being in turn bound to a plurality of objects; b) performing a filtration step such that said objects of a defined size are captured within said extracorporeal circulation system; and c) returning said blood or components thereof into the subject, said blood or blood components containing substantially less immune suppressive particles in comparison to the blood or blood components originally residing in said subject. Enhancing immune response contemplated herein includes one or more of the following: upregulation of T cell, natural killer (NK) cell, natural killer T (NKT) cell, gamma-delta T cell, and B cell function. It is presently preferred that upregulation of one or more of T cell, natural killer (NK) cell, natural killer T (NKT) cell gamma-delta T cell, and B cell function includes prevention of apoptosis. It is also presently preferred that upregulation of one or more of T cell, natural killer (NK) cell, natural killer T (NKT) cell gamma-delta T cell, and B cell function includes enhancing and/or endowment of activity capable of inhibiting cancer progression. Inhibiting cancer progression contemplated herein is accomplished by one or more of the following: direct cytolysis of tumor cells, direct induction of tumor cell apoptosis, induction of tumor cell cytolysis through stimulation of intrinsic host antitumor responses, induction of tumor cell apoptosis through stimulation of intrinsic host antitumor responses, inhibition of tumor cell metastasis, inhibition of tumor cell proliferation, and induction of senescence in the tumor cells. Tumor cells contemplated for treatment in accordance with the present invention are selected from the group of cancers consisting of: soft tissue sarcomas, kidney, liver, intestinal, rectal, leukemias, lymphomas, and cancers of the brain, esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate. Agents capable of binding microvesicles contemplated for use herein are selected from the group consisting of one or more of the following: a) a singular or plurality of antibody species; b) a singular or plurality of proteins (e.g., lectins); c) a singular or plurality of aptamers, d) a surface that selectively restricts microvesicles from passage, and e) a surface with selective adhesion to microvesicles. The plurality of objects contemplated for use herein comprise beads manufactured to a specific size or range of sizes in a manner so that said agents capable of binding microvesicles may be conjugated to said plurality of objects. Preferably such beads have a defined size range to restrict their movement out of said extracorporeal circulation system, e.g., the beads are of a size range larger than pores of hollow fibers used in extracorporeal systems so as to restrict their movement out of said extracorporeal systems. In one aspect, such beads possess properties responsive to an electromagnetic field, such that subsequent to said beads contacting said microvesicles, said beads may be removed or sequestered by said electromagnetic field in order to substantially prevent movement of said beads out of said extracorporeal system. Examples of beads contemplated for use herein are MACS™ beads alone or conjugated with compounds in order to allow said beads to form complexes with said agents capable of binding microvesicles, Dynal™ beads alone or conjugated with compounds in order to allow said beads to form complexes with said agents capable of binding microvesicles, and the like. Antibodies contemplated for use herein have a specificity for proteins selected from a group consisting of one or more of the following: Fas ligand, MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC II-peptide complexes, and proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient. Presently preferred antibodies are specific to Fas ligand, MHC I, and the like. Proteins contemplated for use herein are selected from the group consisting of one or more of the following: Fas, T cell Receptor, protein extracts isolated from T cells, protein extracts isolated from dendritic cells, and proteins found to possess affinity for binding proteins found on microvesicles associated with immune suppression. Surfaces that selectively restrict passage of said microvesicles typically fall in the range of about 20-400 nanometers in size, with microvesicles falling in the range of about 40-300 nanometers in size being presently preferred, and microvesicles in the range of about 50-280 nanometers in size being especially preferred. Exemplary surfaces with selective adhesion to microvesicles are coated with a single compound, or plurality of compounds that bind particles that are enriched in sphingomyelin and with a lower level of phosphatidylcholine as found in the cellular membranes of non-malignant cells. In accordance with another aspect of the invention, agents capable of binding microvesicles can be immobilized on a porous hollow fiber membrane, e.g., on the porous exterior of the hollow fiber membrane. In accordance with still another aspect of the present invention, existing methods and devices of extracorporeal treatment of blood can be integrated (in whole or in part) with the above-described methods to augment ex vivo clearance of microvesicles in a physiologically applicable manner. Exemplary methods contemplated for use herein include: a) hemofiltration; b) hemodialysis; and c) hemodiafiltration, with a preferred method including apheresis followed by filtration. In accordance with various aspects of the present invention, extracorporeal removal of microvesicles can be performed through selective adhesion of said microvesicles to matrices or substrates that are conjugated to agents possessing higher affinity to microvesicles with a high sugar content, in comparison to microvesicles of a lower sugar content. In accordance with yet another embodiment of the present invention, there are provided methods of extracorporeally removing microvesicles from a subject in need thereof, said method comprising passing said subject's whole blood, or separated blood components, through a system capable of selectively binding and retaining microvesicles based on one or more of size, charge, affinity towards lectins, or affinity towards molecules that are known to be present on said microvesicles. In accordance with a further embodiment of the present invention, there are provided methods of extracorporeally removing microvesicles from a subject in need thereof, said methods comprising passing said subject's whole blood, or separated blood components, through a system capable of non-selectively binding and retaining microvesicles based on one or more of size, charge, affinity towards lectins, or affinity towards molecules that are known to be present on said microvesicles. In accordance with a still further embodiment of the present invention, there are provided methods of extracorporeally removing microvesicles from a subject in need thereof, said methods comprising passing said subject's whole blood, or separated blood components, through a system capable of selectively binding and retaining microvesicles based on similarities between properties of microvesicles and membranes of cancer cells. In accordance with yet another embodiment of the present invention, there are provided methods of extracorporeally removing microvesicles from a subject in need thereof, said methods comprising passing said subject's whole blood, or separated blood components, through a system capable of non-selectively binding and retaining microvesicles based on similarities between properties of microvesicles and membranes of cancer cells. When carrying out the above-described methods, the similarities between cancer associated microvesicles and membranes of cancer cells include ability to bind a lectin or plurality of lectins. Reference to lectins herein includes GNA, NPA, Conconavalin A and cyanovirin, with a presently preferred lectin being Conconavalin A. One embodiment of the present invention relates to methods that can be used for extracorporeal treatment of blood or a blood fraction for the removal of microvesicles associated with immune suppression in a cancer patient. Blood is run through an extracorporeal circulation circuit that uses a hollow fiber cartridge with the membranes of said hollow fibers having sufficient permeability for the microvesicles found in the blood to be removed through the membrane of the hollow fibers and into an area outside of the fibers containing a substrate that is bound to a single or plurality of agents capable of adhering to said microvesicles in a manner such that said microvesicles are attached to said agent and do not substantially re-enter the hollow fibers. Within the knowledge of one skilled in the art are available numerous types of hollow fiber systems. Selection of said hollow fiber system is dependent on the desired blood volume and rate of passage of said blood volume through the hollow fiber system. Specifically, hollow fiber cartridges may be used having lengths of 250 mm and containing 535 hollow fibers supplied by Amicon, and having the fiber dimensions: I.D. 180 micron and O.D. 360 micron, and the total contact surface area in the cartridge is 750 cm 2 . Alternatively, the “Plasmaflux P2” hollow fiber filter cartridge (sold by Fresenius) or Plasmart PS60 cartridges (sold by Medical srl) may be used. These and other hollow fiber systems are described by Ambrus and Horvath in U.S. Pat. No. 4,714,556 and incorporated herein by reference in its entirety. Hollow fiber cartridges such as described by Tullis in U.S. Patent Application 20040175291 (incorporated by reference herein in its entirety) may also be used. Furthermore, said hollow fiber cartridges and affinity cartridges in general are thought in U.S. Pat. Nos. 4,714,556, 4,787,974 and 6,528,057, which are incorporated herein by reference in their entirety. Regardless of hollow fiber system used, the concept needed for application of the present invention, is that said hollow fiber filters are required to allow passage of blood cells through the interior of said hollow fiber, and allow diffusion of microvesicles to the exterior. In order to allow such diffusion, the pores on the membrane of the hollow fiber need to be of a diameter sufficient to allow particles ranging from the size of 20 nanometers to 500 nanometers in diameter. More specifically, the pores on the membrane of the hollow fiber need to be of a diameter sufficient to allow particles ranging from the size of 50 nanometers to 300 nanometers in diameter. Even more specifically, the pores on the membrane of the hollow fiber need to be of a diameter sufficient to allow particles ranging from the size of 80 nanometers to 200 nanometers in diameter. During experimentation with different hollow fibers, one skilled in the art would find it useful to utilize particles of similar size ranges as the microvesicles in order to calibrate and quantitate the ability of various pore sizes of hollow filters. One method of performing this is through the utilization of commercially available MACS™ Beads (Milteny Biotech), which have a size of 60 nanometers. Fluorescent, spherical latex beads ranging in size from 25 to 1000 nm are also available for this purpose (e.g., from Duke Scientific (Palo Alto, Calif.)). The substrate or matrix to be used in practicing the present invention needs to allow sufficient permeation of flow so that non-cellular blood components that enter the space exterior to the hollow fiber are distributed throughout the substrate or matrix material, so that substantial contact is made between the microvesicles permeating the hollow fiber filter and the microvesicle-binding agent that is attached to the substrate or matrix. Suitable substrates or matrices are known to one skilled in the art. Said substrates or matrices include silica gel, dextran, agarose, nylon polymers, polymers of acrylic acid, co-polymers of ethylene and maleic acid anhydride, aminopropylsilica, aminocelite, glass beads, silicate containing diatomaceous earth or other substrates or matrices known in the art. Examples of such are described in the following patents, each of which are incorporated by reference herein in their entirety: Lentz U.S. Pat. No. 4,708,713, Motomura U.S. Pat. No. 5,667,684, Takashima et al U.S. Pat. No. 5,041,079, and Porath and Janson U.S. Pat. No. 3,925,152. The agents that are attached to said substrate are chosen based on known affinity to cancer associated microvesicles. Said agents may be capable of non-specifically binding to said microvesicles, in that binding occurs both from non-tumor associated microvesicles, and from tumor associated microvesicles, or conversely, said agents may display a certain degree of selectivity for exosomes derived from tumors. In one embodiment said agents non-specifically bind all microvesicles due to common expression of molecules such as MHC I on microvesicles that are associated with conditions of neoplasia, and microvesicles that are not. Specifically, an agent that would bind both types of microvesicles would be an antibody specific to the non-polymorphic regions of MHC I. Therefore, in the embodiment of the invention in which non-selective removal of microvesicles is sought, anti-MHC I antibodies would be bound to said substrate chosen, and the combination would be placed to reside outside of the hollow fiber filters in order to allow binding of said microvesicles to the substrate, however blood cells and other components of the blood would not be removed during the passage of blood through the encased system containing said hollow fiber filters, exterior substrate, and microvesicle binding agent. In order to achieve non-specific removal of microvesicles, another embodiment of the invention is the use of hollow fiber filters of sufficient size of the pores on the side of the hollow fiber filter for microvesicles to exit, while not allowing blood cells to exit, and passing a continuous solution over said hollow fiber filters in order to clear said microvesicles leaking through the sides of the hollow fiber filters. In such a situation it would be critical to re-introduce the other blood components that escaped the hollow fiber filter, such as albumin, back into the microvesicle purified blood, before returning of the blood to the subject. Alternatively, the hollow-fiber cartridge may be sealed as described in Ambrus. In such a system, both diffusion and convection cause blood fluids (exclusive of blood cells) to pass through the pores in the hollow fibers and into contact with the capture molecules bound to the solid phase matrix. The fluids (e.g. plasma) pass back into the circulation at the distal end of the cartridge through a process known as Starling flow. In this system, there is no significant loss of blood fluids and therefore no need for blood component replacement. In the situations where a substantially specific removal of microvesicles associated with tumors is desired, the said agent bound to said substrate outside of said hollow fiber filters possesses affinity to molecules specifically found on said microvesicles associated with tumors. Said agent may be an antibody to the molecule Fas Ligand, may be a recombinant Fas protein, or may be directed to MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC I-peptide complexes, and proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient. Another embodiment of the invention takes advantage of the similarity of tumor membranes with tumor microvesicles and the known high concentration of mannose and other sugars on tumor membranes compared to membranes of non-malignant cells. In a situation where microvesicles associated with tumors are meant to be withdrawn with a certain degree of selectivity from the systemic circulation of a subject in need thereof, said agent binding the matrix or substrate may be a lectin. Specific methodologies for use of lectins in removal of viruses are described by Tullis in U.S. Patent Application 20040175291 (incorporated by reference herein in its entirety) and these methodologies may also be used in part or in whole for practicing the present invention. In various embodiments of the invention, it is important that said systems include means for maintaining the blood at conditions similar to that found in the host, so that upon returning said blood to the host, no adverse reactions occur. In other words, it is within the scope of the invention to use technologies that are known to one skilled in the art to maintain blood at physiological ion concentrations, osmolality, pH, hematocrit, temperature, and flow in order to avoid harm being caused to the subject subsequent to reinfusion of blood treated as disclosed herein. Said technologies are well known to one skilled in the art. In another embodiment of the invention a system for extracorporeal clearance of microvesicles; either selectively removing tumor associated microvesicles, or non-selectively microvesicles that are found in healthy subjects as well as tumor bearing subjects. The invention comprises several interacting components whose primary purpose is the formation of a functional circuit capable of depleting microvesicles in order to de-repress, or in some cases augment the immune response of a cancer patient. More specifically, a means for separating blood from a subject in need thereof (e.g., a cancer patient) into plasma and cellular elements is used. Appropriate means for such separation are available commercially, and well-known to the skilled artisan. They include, for example, the Exorim System, the Fresenius Hemocare Apheresis system, and the Gambo Prisma System. Plasma purified through said separation means is then run over an array of filtration means, said filtration means possessing a higher affinity towards tumor associated microvesicles in comparison to other molecules. Said filtration means includes, in some embodiments, microvesicle binding agents immobilized to a substrate. Said microvesicle binding agents include but are not limited to antibodies, proteins, or compounds with selective affinity towards microvesicles associated with the cancer or not associated. Examples of such agents include antibodies to Fas ligand, MHC I, MHC II, CD44, placental alkaline phosphatase, TSG-101, MHC I-peptide complexes, MHC II-peptide complexes, or proteins found to be present on the exterior of microvesicles contributing to immune suppression found in a cancer patient, as well as lectins such as conconavalin A, phytohemagluttanin, GNA, NPA, and cyanovirin. Said substrate is selected from known substrates previously used in the are, these include, for example SEPHAROSE™ made by Amersham-Biosciences, Upsala, Sweden, as well as acrylamide and agarose particles or beads. The substrates used should have the properties of being able to tightly bind the microvesicle binding agent, the ability to be produced in a sterile means, and be compatible with standard dialysis/extracorporeal tubings. In other embodiments, the agent capable of binding the tumor associated or non-tumor associated microvesicles is immobilized to a filter membrane or capillary dialysis tubing, where the plasma passes adjacent to, or through, the membranes to which said agent capable of binding the tumor associated or non-tumor associated microvesicles are bound. Suitable filters include those mentioned previously with respect to separation of blood components. These may be the same filters, having immobilized agents capable of binding microvesicles (either tumor associated or non-associated, or may be arranged in sequence, so that the first filter divides the blood components and the secondary, tertiary and additional filter removes one or more of the components of said cancer associated microvesicles. Conjugation of the agent capable of binding the tumor associated or non-associated microvesicle to said substrate may be accomplished by numerous means known in the art. Said means include avidin-streptavidin, cynanogen bromide coupling, the use of a linker such as a polyethylene glycol linker. A means of returning the blood together with plasma substantially cleared of tumor associated microvesicles back to said subject is also provided in the invention. Preferred means are chosen by one of skill in the art based on the desired application, extent of microvesicle removal desired, patient condition, extracorporeal method chosen, and microvesicle-binding agent chosen. In one embodiment of the invention, extracorporeal removal of microvesicles is performed in a cancer patient in order to accelerate the rate of tumor-specific T cell proliferation and activation. It is known in the art that tumors contain antigens that are specific to the tumor (e.g. the bcr-abl product p210 in CML), expressed on other tissues but overexpressed on cancer cells (e.g. tyrosinase), or expressed embryonically and re-expressed in the cancer (e.g. telomerase). Vaccination to such antigens has been demonstrated to induce immune response, and in some cases generation of cytotoxic T lymphocytes (CTL). Unfortunately, despite much effort in development of cancer vaccines, clinical translation has been slow, with most cancer vaccines not demonstrating efficacy in the double-blind setting. In order to increase efficacy of cancer vaccines, it is important that the cancer patient has an immunological environment in which proper T cell activation may occur. It is known that high numbers of microvesicles are present in the circulation of patients with a wide variety of histologically differing tumors including melanoma (52), ovarian (53), colorectal (54), and breast (55). Importantly, such microvesicles are known to induce suppression of immunity via direct mechanisms such as induction of T cell death via FasL expression (52), through indirect mechanisms such as stimulation of myeloid suppressor cell activity (54). Indeed, numerous mechanisms are known for suppression of T cell immunity by cancer-secreted microvesicles (56-59). Accordingly, in one embodiment a cancer patient is treated with a therapeutic cancer vaccine either prior to, concurrently, or subsequent to undergoing extracorporeal removal of exosomes. Said cancer vaccine may be used for stimulation of immune responses to antigens that are found either exclusively on the tumor, to antigens found on non-malignant tissues but at higher concentration on the tumor, or antigens whose presence is required for tumor functionality. In a specific embodiment of the invention, tumor vaccination is performed to peptides, polypeptides, glycoproteins, peptidomimetics, or combinations thereof Tumor vaccination may be performed in the context of a cell therapy, such as, for example, administration of dendritic cells that are pulsed with tumor antigens or tumor lysates. Tumor vaccines are commonly known in the art and are described in the following reviews, which are incorporated by reference (60-64). Examples of tumor antigens that may be used in the practice of the current invention include CDK-4/ma MUM-1/2, MUM-3, Myosin/m, Redox-perox/m, MART-2/m, Actin/4/ma, ELF2-M, CASP-8/ma, HLA-A2-R17OJ, HSP70-2/ma, CDKN2A, CDC27a, TPI, LDLR/FUT Fibronectin/m, RT-PTP-K/ma, BAGE, GAGE, MAGE, telomerase, and tyrosinase, and fragments thereof. In one specific embodiment, a patient with ovarian cancer is selected for treatment with cancer vaccination. Said patient plasma is assessed for exosomal content based on methods known in the art, as for example described in the following study and incorporated herein by reference (65). In specific method involves the following procedure: ETDA treated plasma is purified from peripheral blood by centrifugation at 500 g for half-hour. Separation of cellular debris is accomplished by a second centrifugation at 7,000 g for an additional half-hour. Exosomes are subsequently collected by centrifugation at 100,000 g for 3 hours, followed by a washing step in PBS under the same conditions. Using this procedure, approximately 0.5-0.6 ug/ml of exosomal protein is detected from healthy volunteers as visualized by the Bradfort Assay (Bio-Rad, Hercules, Calif.) (66). In contrast, the plasma of cancer patients typically contains a higher exosomal yield, ranging between 200-500 ug/ml. This is in agreement with studies describing high concentrations of “membrane vesicles” found systemically circulating in cancer patients (65). For the practice of the invention patients with high exosomal content compared to healthy volunteers are selected. For example, patients with exosomal content above two fold the concentration of exosomes in healthy volunteers may be treated by the invention. In another embodiment, patients with exosomal contented 10-fold higher than exosomal content of healthy volunteers are treated. In another embodiment of the invention, patients with higher exosomal content than healthy volunteers which have spontaneous T cell apoptosis present are selected for treatment. Protocols for assessment of spontaneous T cell apoptosis are known in the art and described, for example by Whiteside's group and incorporated here by reference (67). Assessment of exosome immune suppressive activity may be quantified by culture of exosomes purified from patient plasma with a Fas expressing T cell line such as the Jurkat clone E6.1 (ATCC Manassas, Va.). These cells may be cultured in standard conditions using the method described by Andreola et al and incorporated herein by reference (52) in order to develop a standardized assay. Briefly 10 6 /ml Jurkat cells are seeded in 24-well plates in 10% FBS RPMI 1640 and co-cultured with escalating concentrations of exosomes from healthy volunteers, as well as cancer patients. Apoptosis of Jurkat cells may be quantified by assessment of Annexin-V staining using flow cytometry. Patients displaying elevated numbers of exosomes, and/or apoptotic T cells, and/or possessing exosomes capable of inducing T cell apoptosis are selected for extracorporeal removal of said exosomes. In one preferred embodiment, patent blood is passaged over an extracorporeal circuit for a time sufficient to substantially reduce exosome burden. Reduction of exosome burden is quantified as described above. Correlation can be made between exosome concentration and spontaneous T cell apoptosis. When reduction of both plasma exosome concentration and spontaneous T cell apoptosis is achieved, said patient may be immunized with a tumor vaccine. Alternatively, patients may have exosome removal performed without immunization with a tumor vaccine so as to allow for endogenous antitumor responses to be derepressed. Alternatively patients may be treated with a non-specific immune stimulator, said immune stimulator may be a small molecule (e.g. muramyl dipeptide, thymosin, 7,8-disubstituted guanosine, imiquimod, detoxified lipopolysaccharide, isatoribine or alpha-galactosylceramide), a protein (e.g. IL-2, IL-7, IL-8, IL-12, IL-15, IL-18, IL-21, IL-23, IFN-a, b, g, TRANCE, TAG-7, CEL-1000, bacterial cell wall complexes, or LIGHT), or an immunogeneic nucleic acid (e.g. short interfering RNA targeting the mRNA of immune suppressive proteins, CpG oligonucleotides, Poly IC, unmethylated oligonucleotides, plasmid encoding immune stimulatory molecules, or chromatin-purified DNA). Said non-specific immune stimulants are known in the art and in some cases are already in clinical use. Said non-specific immune stimulants in clinical use include interleukin-2, interferon gamma, interferon alpha, BCG, or low dose cyclophosphamide. In another embodiment extracorporeal removal of exosomes is performed in conjunction with chemotherapy in order to derepress immune suppression caused by exosomes, while at the same time allowing said chemotherapy to perform direct tumor inhibitory functions. Alternatively, extracorporeal removal of exosomes may be utilized to remove increased exosomes caused by tumor cell death during chemotherapy use. Numerous types of chemotherapies are known in the art that may be utilized in the context of the present invention, these include: alkylating agents such as thiotepa and cyclosphosphamide (CYTOXAN™); alkyl sulfonates such as busulfan, improsulfan and piposulfan; aziridines such as benzodopa, carboquone, meturedopa, and uredopa; ethylenimines and methylamelamines including altretamine, triethylenemelamine, triethylenephosphoramide, triethylenethiophosphoramide and trimethylolomelamine; nitrogen mustards such as chlorambucil, chlomaphazine, cholophosphamide, estramustine, ifosfamide, mechlorethamine, mechlorethamine oxide hydrochloride, melphalan, novembichin, phenesterine, prednimustine, trofosfamide, uracil mustard; nitrosureas such as carmustine, chlorozotocin, fotemustine, lomustine, nimustine, ranimustine; antibiotics such as aclacinomysins, actinomycin, authramycin, azaserine, bleomycins, cactinomycin, calicheamicin, carabicin, carminomycin, carzinophilin, chromomycins, dactinomycin, daunorubicin, detorubicin, 6-diazo-5-oxo-L-norleucine, doxorubicin, epirubicin, esorubicin, idarubicin, marcellomycin, mitomycins, mycophenolic acid, nogalamycin, olivomycins, peplomycin, potfiromycin, puromycin, quelamycin, rodorubicin, streptonigrin, streptozocin, tubercidin, ubenimex, zinostatin, zorubicin; anti-metabolites such as methotrexate and 5-fluorouracil (5-FU); folic acid analogues such as denopterin, methotrexate, pteropterin, trimetrexate; purine analogs such as fludarabine, 6-mercaptopurine, thiamiprine, thioguanine; pyrimidine analogs such as ancitabine, azacitidine, 6-azauridine, carmofur, cytarabine, dideoxyuridine, doxifluridine, enocitabine, floxuridine, 5-FU; androgens such as calusterone, dromostanolone propionate, epitiostanol, mepitiostane, testolactone; anti-adrenals such as aminoglutethimide, mitotane, trilostane; folic acid replenisher such as frolinic acid; aceglatone; aldophosphamide glycoside; aminolevulinic acid; amsacrine; bestrabucil; bisantrene; edatraxate; defofamine; demecolcine; diaziquone; elfornithine; elliptinium acetate; etoglucid; gallium nitrate; hydroxyurea; lentinan; lonidamine; mitoguazone; mitoxantrone; mopidamol; nitracrine; pentostatin; phenamet; pirarubicin; podophyllinic acid; 2-ethylhydrazide; procarbazine; PSK®; razoxane; sizofiran; spirogermanium; tenuazonic acid; triaziquone; 2,2′,2″-trichlorotriethylamine; urethan; vindesine; dacarbazine; mannomustine; mitobronitol; mitolactol; pipobroman; gacytosine; arabinoside (“Ara-C”); cyclophosphamide; thiotepa; taxanes, e.g. paclitaxel (TAXOL®, Bristol-Myers Squibb Oncology, Princeton, N.J.) and docetaxel (TAXOTERE®, Rhone-Poulenc Rorer, Antony, France); chlorambucil; gemcitabine; 6-thioguanine; mercaptopurine; methotrexate; platinum analogs such as cisplatin and carboplatin; vinblastine; platinum; etoposide (VP-16); ifosfamide; mitomycin C; mitoxantrone; vincristine; vinorelbine; navelbine; novantrone; teniposide; daunomycin; aminopterin; xeloda; ibandronate; CPT-11; topoisomerase inhibitor RFS 2000; difluoromethylomithine (DMFO); retinoic acid; esperamicins; and capecitabine. In one embodiment, frequency and length of extracorporeal treatment is performed based on the amount of time (or blood volume) needed for reduction of exosome concentration to a level significant to correlate with reduction in spontaneous T cell apoptosis. In one embodiment a reduction of spontaneous T cell apoptosis by approximately 20% in comparison to pre-extracorporeal treatment values is judged as sufficient. In another embodiment a reduction of spontaneous T cell apoptosis by approximately 50% in comparison to pre-extracorporeal treatment values is judged as sufficient. In another embodiment a reduction of spontaneous T cell apoptosis by approximately 90% in comparison to pre-extracorporeal treatment values is judged as sufficient. Although assessment of spontaneous T cell apoptosis is used in some embodiments for judging the frequency, and/or time, and/or blood volume needed for extracorporeal treatment, other means of measuring immune responses may be used. For example restoration of cytokine production (68), T cell proliferation (69), or TCR-zeta chain expression (70) are all known in the art and described in the references incorporated herein. One skilled in the art will appreciate that these methods and devices are and may be adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The methods, procedures, and devices described herein are presently representative of preferred embodiments and are exemplary and are not intended as limitations on the scope of the invention. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the disclosure. It will be apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention. EXAMPLES There are numerous methods of conjugating antibodies to substrates that are used for packing the Hollow Fiber Cartridge. In the examples, the binding of proteins and other chemical binding agents is generally performed using variations of the glutaraldehyde techniques described by Ambrus and Horvath in U.S. Pat. No. 4,714,556 (incorporated herein by reference in its entirety). Example 1 Preparation of GNA Covalently Coupled to Agarose using Cyanogen Bromide Cyanogen bromide (CNBr) activated agarose was used for direct coupling essentially according to Cuatrecasas, et al (Cuatracasas, Wilchek and Anfinsen. Proc Natl Acad Sci USA 61(2): 636-643, 1968). In brief, 1 ml of GNA at a concentration of 10 mg/ml in 0.1M NaHCO 3 pH 9.5 is added to 1 ml CNBr activated agarose (Sigma, St. Louis, Mo.) and allowed to react overnight in the cold. Care must be taken to maintain alkaline pH to prevent the potential release of HCN gas. When the reaction is complete, unreacted materials are aspirated and the lectin coupled agarose washed extensively with sterile cold PBS. The lectin agarose affinity matrix is then stored cold until ready for use. Alternatively, GNA agarose is available commercially from Vector Labs (Burlingame, Calif.) Example 2 Preparation of an Antibody Covalently Coupled to Glass Beads via Schiff's Base and Reduction with Cyanoborohydride The affinity matrix was prepared by a modification of the method of Hermanson (Hermanson. Bioconjugate Techniques: 785, 1996). Anti-HIV monoclonal antibody dissolved to a final protein concentration of 10 mg/ml in 0.1M sodium borate pH 9.5 is added to aldehyde derivatized silica glass beads (BioConnexant, Austin Tex.). The reaction is most efficient at alkaline pH but will go at pH 7-9 and is normally done at a 2-4 fold excess of protein over coupling sites. To this mixture is added 10 ul 5M NaCNBH 3 in 1N NaOH (Aldrich, St Louis, Mo.) per ml of coupling reaction and the mixture allowed to react for 2 hours at room temperature. At the end of the reaction, remaining unreacted aldehyde on the glass surfaces are capped with 20 ul 3M ethanolamine pH 9.5 per ml of reaction. After 15 minutes at room temperature, the reaction solution is decanted and the unbound proteins and reagents removed by washing extensively in PBS. The matrix is the stored in the refrigerator until ready for use. Example 3 Preparation of an Exosome Specific Antibody Covalently Coupled to Chromosorb (Diatomaceous Earth) Using Glutaraldehyde Preparation of aminated diatomaceous earth is accomplished using γ-aminopropyl triethoxysilane (GAPS) (Sigma Chemical, St. Louis, Mo.) and Chromosorb 60/80 mesh. Although other grades of diatomaceous earth may be used, Chromosorb of this mesh size (200-300 microns in diameter) is often used to prevent small particulates from entering the sample through the largest available pore sizes found in hollow-fiber cartridges used for plasma separation (˜0.5 micron). Amino Chromosorb was prepared by suspension in an excess of 5% aqueous solution of GAPS in an overnight reaction. Aminated-Chromosorb was washed free of excess reagent with water and ethanol and dried overnight in a drying oven to yield an off white powder. One gram of the powder was then suspended in 5 ml 5% glutaraldehyde (Sigma) for 30 minutes. Excess glutaraldehyde was then removed by filtration and washing with water until no detectable aldehyde remained in the wash using Schiff's reagent (Sigma Chemical). The filter cake was then resuspended in 5 ml of Sigma borohydride coupling buffer containing 2-3 mg/ml of the antibody and the reaction allowed to proceed overnight at 4 degrees C. At the end of the reaction, excess antibody is washed off and the remaining aldehyde reacted with ethanolamine as described. After final washing in sterile PBS, the material was stored cold until ready for use. Example 4 Preparation of an AntiFas-Ligand Specific Antibody Covalently Coupled to Polyacrylate Beads Using Glutaraldehyde and Azide Anti-Fas Ligand antibody (NOK-1 mouse anti-human as described by Kayagaki et al in U.S. Pat. No. 6,946,255 and incorporated herein by reference in its entirety) is dissolved in a concentration of 50-200 mg./ml. with human serum albumin in a phosphate-buffered aqueous medium of pH 7.0. Glutaraldehyde at a concentration of 0.05-10% is added to the solution which is then incubated for 1-24 hours, but preferably 12 hours, at 4 degree. C. Excess glutaraldehyde that remains in the reaction mixture is removed by addition of glycine, or other suitable compounds known in the art, to the solution at the end of incubation. This solution is then diafiltered through a membrane having a minimal retentively value of 500,000 molecular weight. The diafiltered antibody-bearing product is dissolved in saline or dialysis fluid. To obtain a reactive polymer to act as a substrate for said anti-Fas Ligand antibody, polyacrylic acid polymer beads (≦1 micron in diameter) are activated by the azide procedure (51). The ratios of antibody to reactive polyester are selected to avoid excessive reaction. If this ratio is appropriately adjusted, the spacing of the antibody along the polymer chain will allow a binding of the antibody with the antigen found on microvesicle without untoward steric hindrances and the antibody conjugate is intended to remain soluble. Said antiFas Ligand antibody conjugates are subsequently loaded into a hollow fiber filter cartridge, on the exterior of said hollow fibers. The external filling ports are then sealed. This allows for passage of blood cell components through the lumen of said hollow fibers. Blood plasma containing the microvessicles, convects and diffuses through pores in the hollow fibers into the extralumenal space where it contacts the antibody-polyacrylate conjugates. Treated plasma inside the cartridge diffuses back into the general circulation leaving the microvesicles attached to the insolublized anti-FAS Ligand antibody. Example 5 Patient Treatment Using AntiFas-Ligand Specific Antibody Covalently Coupled to Polyacrylate Beads from Example 4 A patient with stage IV unresectable colorectal cancer presents with a suppressed ability to produce interferon-gamma subsequent to ex vivo stimulation of peripheral blood mononuclear cells with anti-CD3. In order to de-repress the ability of said patients immune response to produce interferon gamma, said patient is treated with an extracorporeal device capable of removing microvesicles that contribute, at least in part, to the suppressed production of interferon gamma. Said medical device is manufactured as in Example 4: The modified hollow fiber filter is connected to a veno-venous dialysis machine and connected to the circulation of said patient for a time period necessary to remove microvesicles associated with suppression of interferon gamma production. Vascular access is obtained via a double-lumen catheter in the subclavian or femoral vein. For this specific application the hollow fiber hemofilter is connected to a flow-controlled blood roller pump, the blood flow rate (Q b ) is set at 100 to 400 ml/min, (more preferably at 200 to 300 ml/min depending on the cardiovascular stability of the patient). The dialysis circuit is anticoagulated with a continuous heparin infusion in the afferent limb. The activated clotting time (ACT) is measured every hour, and the heparin infusion is adjusted to maintain the ACT between 160 and 180 seconds. Said patient is monitored based on the concentration of microvesicles expressing Fas Ligand in circulation, as well as by ability of said patient lymphocytes to produce interferon gamma in response to mitogenic or antibody stimulation. Upon upregulation of interferon gamma production, said patient can be administered a tumor vaccine with the goal of antigen-specifically stimulating host immune responses in an environment conducive to immune-mediated clearance of the primary and/or metastatic tumors. Example 6 Removal of Exosomes from Blood Using Plasmapheresis Selective removal of exosomes from blood may be accomplished using plasmapheresis combined with affinity capture using any of the matrices described in Examples 1-5. Plasmapheresis is done using either centrifugal separation or hollow-fiber plasma separation methods. The blood circuit is anticoagulated with a continuous heparin infusion in the afferent limb. The activated clotting time (ACT) is measured every hour, and the heparin infusion is adjusted to maintain the ACT between 160 and 180 seconds. The plasma obtained from the patient may be discarded and replaced with a combination of normal saline and fresh plasma from healthy donors (i.e. plasma exchange). Alternatively, the plasma containing the microvesicles can be pumped at 60-100 ml/min over the affinity matrix which captures the exosomes. The cleaned plasma may then be reinfused into the patient. A similar system (the Prosorba column) has been described for the removal of immunoglobulin complexes from patients with drug refractory rheumatoid arthritis (71, 72). The clearance of the microvesicles may be monitored based on the concentration of microvesicles expressing Fas Ligand remaining in circulation. Example 7 Direct Coupling of an Aptamer Specific for Tumor Exosomes to the Hollow-Fibers In hollow-fiber based devices, more intimate contact with the blood is obtained by direct coupling of the capture agent to the hollow-fibers. Aptamers are short pieces of synthetic DNA and its chemical derivatives which bind to specific antigens (i.e. DNA antibodies). The process for generating aptamers is described in detail in U.S. Pat. No. 5,567,588 (1996; issued to Gold et al.; incorporated herein by reference in its entirety). In this example the isolation of Fas Ligand protein specific DNA aptamers and the production of hollow-fiber coupled aptamer affinity matrices are described. Purified Fas Ligand protein is chemically coupled to agarose using Amino-Link agarose (Pierce Chemical Co.). AminoLink Coupling Gel is a 4% crosslinked beaded agarose support, activated to form aldehyde functional groups which develops a stable bond, in the form of a secondary amine, between the gel and the protein with coupling efficiencies of 85% between pH 4-10. In this example 2 ml Fas Ligand protein (1 mg/ml in coupling buffer) is applied to the Aminolink gel for 7 hours at 4 degrees C. Unreacted protein is then washed off with 25 volumes of phosphate buffered saline (PBS) and the product material stored cold until ready for use. Next DNA oligonucleotides, typically 80 nucleotides long are prepared containing the following elements. First a PCR primer site of 20 nucleotides on both the 5′ and 3′ ends and a 40 base segment in the middle of the molecule prepared with a random mixture of bases. This generates a very large number of DNA species from which the specific aptamer (i.e. DNA antibody) may be selected. The DNA capable of binding selectively to the target protein Fas Ligand is then selected by multiple rounds of binding to the immobilized Fas Ligand interspersed with polymerase chain reaction (PCR) amplification on the recovered fragments. The final material with high selectivity for Fas Ligand may then be cloned and sequenced to yield a consensus sequence. Copies of the consensus sequence are then chemically synthesized with 5′ or 3′ terminal amino groups and coupled to a solid phase such as described in Example 3. In this specific example, the chemically synthesized FasL specific aptamer containing a terminal amine is to be coupled directly to polysulfone hollow-fibers in situ in a plasma separator cartridge. To accomplish this, the cartridge is first exposed to a solution of 4% human serum albumin (HSA) reacted overnight at 4 degrees C. The adsorbed HSA is then cross-linked with glutaraldehyde. Excess glutaraldehyde is then briefly washed out with water. The cartridge is then filled with Sigma cyanoborohydride coupling buffer containing 2-3 mg/ml of the aminated FasL aptamer and reacted overnight at 4 degrees C. At the end of the reaction, excess aptamer is washed off and the remaining unreacted aldehyde reacted with ethanolamine. After final washing in sterile PBS, the cartridge was dried in sterile air, packaged and sterililzed using gamma-irradiation (25-40 kGy) and stored in a cool, dark area until ready for use. Those skilled in the art recognize that the aspects and embodiments of the invention set forth herein may be practiced separate from each other or in conjunction with each other. Therefore, combinations of separate embodiments are within the scope of the invention as disclosed herein. All patents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein any of the terms “comprising,” “consisting essentially of” and “consisting of” may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions indicates the exclusion of equivalents of the features shown and described or portions thereof. It is recognized that various modifications are possible within the scope of the present invention. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the disclosure. REFERENCES 1. Wiemann, B., and Starnes, C. O. 1994. Coley's toxins, tumor necrosis factor and cancer research: a historical perspective. Pharmacol Ther 64:529-564. 2. Woglom, W. 1929. Cancer Rev. 4:129. 3. Ichim, C. V. 2005. Revisiting immunosurveillance and immunostimulation: Implications for cancer immunotherapy. J Transl Med 3:8. 4. Romagnani, S. 1992. Human TH1 and TH2 subsets: regulation of differentiation and role in protection and immunopathology. Int Arch Allergy Immunol 98:279-285. 5. Sanders, V. M. 2005. Epigenetic regulation of Th1 and Th2 cell development. Brain Behav Immun. 6. 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1a

RELATED APPLICATIONS [0001] This application claims the benefit of German Patent Application No. DE 102013208610.5, filed May 10, 2013. The entire contents of the priority document are hereby incorporated herein by reference. TECHNICAL FIELD [0002] The present teachings relate generally to patient transportation systems. BACKGROUND [0003] In hospitals, patients may be transported between different diagnostic and therapeutic instruments, or between holding areas and examination rooms. Oftentimes, patients are transported in a lying position on a patient transportation device (e.g., a trolley). For diagnosis or treatment with a diagnostic or treatment instrument (e.g. computed tomography scanner, magnetic resonance imaging scanner, x-ray instrument, radiation therapy instrument, etc.), a patient may be moved from the patient transportation device to a space provided for the diagnosis or treatment procedure. The patient, who may be in a poor physical state, may be moved with minimum exertion on the part of the patient. Conventional patient transportation devices are, in part, configured for docking onto a medical instrument or a medical modality. For example, the patient transportation device may be fastened to the medical instrument in order to simplify repositioning of the patient. [0004] Quick and efficient docking of a patient transportation device onto a medical instrument may reduce patient stress and prevent interruption of the medical workflow. United States Patent Application Publication No. US 2006/0167356 A1 describes a trolley that provides automatic assistance in the docking procedure. Sensors support the locking of the trolley onto a medical instrument, thereby facilitating the connection and minimizing difficulties encountered by operating staff. SUMMARY AND DESCRIPTION [0005] The scope of the present invention is defined solely by the appended claims, and is not affected to any degree by the statements within this summary. [0006] The present embodiments may obviate one or more of the drawbacks or limitations in the related art. For example, some embodiments may provide assistance to the operating staff when transporting patients by a patient transportation device. [0007] A patient transportation system in accordance with the present teachings includes a patient transportation device (e.g., a trolley) with a plurality of wheels. The device is configured to dock onto a medical instrument or medical modality (e.g., computed tomography scanner, magnetic resonance imaging scanner, x-ray instrument, radiation therapy instrument, etc.). [0008] Furthermore, the patient transportation system has a registration apparatus configured to register information. As used herein, the term “information” includes the registration of a plurality of items of information (e.g., individual associated or separate items of information). By way of example, the information may also be an image. [0009] The patient transportation system also includes a control unit configured to change at least one wheel position of at least one wheel of the plurality of wheels based on information registered by the registration apparatus. The change in wheel position may involve a change in direction. The change in wheel position may also involve locking a wheel, thereby braking the patient transportation device. In some embodiments, the registration apparatus and the control unit may be part of the patient transportation device. In other embodiments, the registration apparatus and the control unit are not part of the patient transportation device. [0010] In accordance with the present teachings, assistance may be provided for the docking procedure itself, and for the approach of the patient transportation device to the docking interface of the medical instrument. The operating staff may be assisted in bringing the transportation device to the interface provided for docking, thereby simplifying transportation and docking for medical examinations or treatments. [0011] The information registered by the registration apparatus may contain directional information, distance information, movement information or a combination of thereof. In some embodiments, the information may not directly contain one of directional information, distance information, or movement information. Instead, directional information, distance information, movement information or a combination thereof may be obtained from the registered information by evaluation (e.g., by analyzing an image captured by a camera). By way of example, the directional information may include the direction to the docking interface of the medical instrument. The distance information may include the distance to the medical instrument. By way of example, both the directional information and the distance information are registered and used to calculate the wheel position. The movement produced by an operator moving or pushing the transportation device may be detected and used for setting the wheel position. By way of example, a movement sensor may detect braking by the operator and assist the braking by locking the wheels. [0012] The registration apparatus may include one or more sensors configured to detect the information. The sensor may be an optical sensor (e.g., including a camera), a sensor operating on a capacitive basis, an ultrasound-based sensor, or an RFID-based sensor. [0013] The patient transportation system may be identical to the patient transportation device. The registration apparatus may include a plurality of sensors that are arranged, in some embodiments, at the front end of and under the patient transportation device. [0014] In other embodiments, the registration apparatus is not part of the patient transportation device. Rather, the registration apparatus is arranged in the vicinity of the medical instrument. The registration apparatus, for registration purposes, may be connected to a transmission device arranged externally to the patient transportation device. The connection may be physical but may also include a radio link. The transmission device may be configured to transmit control information to the patient transportation device. The patient transportation device may be equipped with a receiver configured to receive control information transmitted by the transmission device. To process or evaluate the information registered by the registration apparatus, a registration apparatus may be provided external to the patient transportation device. An evaluation device configured to evaluate or analyze the registered information may be connected to the registration apparatus that is arranged external to the patient device and may be connected to the transmission device. In some embodiments, the connection is not physical but may be achieved, for example, by telecommunication. The evaluation may include calculation of a direction from a recorded image. The evaluation device may be provided external to the patient transportation device in the case of a magnetic resonance imaging scanner to facilitate shielding of the evaluation device from magnetic fields. [0015] In some embodiments, the patient transportation device includes a motor configured to interact with the control unit for changing the at least one wheel position. The motor may be further configured for driving the wheels and/or for adjusting the height of a patient bearing. Alternatively, one or two separate motors may also be provided for driving the wheels and/or for adjusting the height of a patient bearing. [0016] The information registered by the registration apparatus may include a marking in the vicinity of the medical instrument or a camera image. The registration apparatus may be suitably arranged depending on the position and type of information to be registered. In some embodiments, a marking may be provided on the floor in the vicinity of the medical instrument, and the registration apparatus may be attached to the underside of the patient transportation device. The marking may be registered by the registration apparatus if the marking is situated underneath the patient transportation device in a registration region of the registration apparatus. The marking may include a line that allows continuous registration of a path to the medical instrument. Alternatively, a plurality of separate markings may be provided. The plurality of separate markings may be arranged at such a distance from one another that at least one marking is detected at all times in the registration region (e.g., a region that may be detected by one or more sensors of the registration apparatus). In some embodiments, the marking may include distance information relating to the distance between the patient transportation device and the medical instrument. The distance information may be provided to initiate an action (e.g. braking, directional adaptation, etc.) that relates to the docking of the patient transportation device onto the medical instrument. [0017] In some embodiments, the patient transportation system includes a sensor (e.g. an ultrasound sensor) configured to establish the distance between the patient transportation device and the medical instrument. The patient transportation system may be configured to initiate an action (e.g. braking, directional adaptation, etc.) that relates to the docking of the patient transportation device onto the medical instrument based on the established distance. [0018] In some embodiments, the patient transportation device includes a central wheel. The wheel position of the central wheel is controlled by the information. The central wheel may be coupled (e.g., mechanically) to one or more of the other wheels of the plurality of wheels. The wheel position of the coupled wheels may be adapted or set by the coupling based on the wheel position of the central wheel. In some embodiments, the central wheel may be provided in the form of a plurality of wheels (e.g., two) that may be selectively coupled to other wheels, thereby providing better control. [0019] A mobile medical device in accordance with the present teachings may include features analogous to those described herein in connection with the patient transportation device. [0020] A mobile medical instrument configured to dock a patient transportation device onto a medical instrument includes a plurality of wheels, a registration apparatus configured to register information, and a control unit configured to change at least one wheel position of at least one wheel of the plurality of wheels based on information registered by the registration apparatus. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 shows a perspective view of a docking device. [0022] FIG. 2 shows an example of a patient transportation system. [0023] FIG. 3 shows an example of the coupling of wheels in an exemplary patient transportation system. [0024] FIG. 4 shows an example of a patient transportation system that includes a control system configured as a double wheel. [0025] FIG. 5 shows an example of a patient transportation system configured for partial external registration of information. [0026] FIG. 6 shows a schematic image of an example of a patient transportation device. [0027] FIG. 7 shows a schematic image of an example of guiding an approach of an exemplary patient transportation device by a line marking. [0028] FIG. 8 shows an example of an alternative marking system. [0029] FIG. 9 shows an example of a system that includes an exemplary mobile medical instrument. [0030] FIG. 10 shows an example of a system with a line marking that includes distance information. DETAILED DESCRIPTION [0031] FIG. 1 shows the front docking region of a patient transportation device 2 and a docking module 20 fastened to a medical instrument (not shown). The components shown in FIG. 1 define a mechanical interface designed for locking the patient transportation device 2 on the medical instrument. The docking procedure has an associated outlay and is to be learned by the operating staff. For successful docking, the patient transportation device 2 is led to the docking module 20 at the correct position and at angle. [0032] FIG. 2 shows a patient transportation device 2 , configured in accordance with the present teachings. The control is implemented by a wheel 11 that is fastened to the central lower region of the patient transportation device 2 . A motor unit 6 that contains first motor 61 and second motor 62 is situated over the wheel 11 . The first motor 61 controls the position of the wheel 11 and the second motor 62 drives the wheel. Fastening the motor centrally in the lower region of the patient transportation device may facilitate docking onto a magnetic resonance imaging scanner since the positioning minimizes magnetic interference. The patient transportation device 2 contains a control device 5 (e.g. a microprocessor). The control commands for the motor unit 6 are generated by the control device 5 . Additional wheels, such as first wheel 12 , second wheel 13 , third wheel 14 , and fourth wheel 15 , may be coupled to the central wheel 11 . [0033] The coupling is shown in FIG. 3 . The central wheel 11 is coupled to the first wheel 12 and the second wheel 13 by a coupling mechanism 7 . The positions of the first wheel 12 and the second wheel 13 adapt based on the position of the central wheel 11 . The motor component 6 changes the wheel position of the central wheel 11 . Different motors for controlling and driving the wheels and for adjusting the height of the patient transportation device may be used. In some embodiments, one motor is used. In other embodiments, a plurality of motors is used. [0034] FIG. 4 shows an embodiment of the patient transportation device that includes a double wheel 11 in place of a single wheel. FIG. 4 also shows a component 8 for docking (e.g., a docking interface) and an operator 9 . The patient transportation device may include movement sensors that assist the movement (e.g., direction or braking) produced by the operator 9 . [0035] FIG. 5 shows a further embodiment of a patient transportation system in accordance with the present teachings. The patient transportation device 2 shown in FIG. 5 is configured to assist the approach to the medical modality 1 along a path 5 . The patient device may be formed with a central wheel or a central pair of wheels 11 . The central wheel or the central pair of wheels 11 may be coupled to other wheels, such as first wheel 12 , second wheel 13 , third wheel 14 , and fifth wheel 15 . The registration apparatus contains two subsystems. A first subsystem is fastened to the patient transportation device 2 . The second subsystem is fastened external to the patient transportation device. The registration subsystem on the patient transportation device 2 includes a sensor 21 that determines a distance 4 from the medical modality 1 (e.g., using ultrasound). A camera 22 fastened close to the ceiling may be provided as an external registration subsystem. The camera 22 records an image of the patient transportation device 2 and the modality 1 . The image is transmitted to an evaluation device 221 that is shielded from magnetic fields by a shield 222 . [0036] The evaluation device 221 determines or calculates control information (e.g., a current approach vector of the patient transportation system 2 and the deviation thereof from an ideal approach vector). The evaluation system 221 establishes control information (e.g. wheel position) and passes the control information to a transmitter 223 that transmits the control information wirelessly to the receiver 224 of the patient transportation device 2 . The wheel position may be adapted on the basis of the control information. [0037] FIG. 6 shows a further embodiment of a patient transportation device 2 in accordance with the present teachings. The patient transportation device 2 includes a central wheel 11 , first wheel 12 , second wheel 13 , third wheel 14 , and fourth wheel 15 . The transportation device 2 includes a handle 25 for manual movement. As shown in FIG. 6 , the patient transportation device 2 includes first motor 61 and second motor 62 . The first motor 61 sets the position of the central wheel 11 . The second motor 62 controls height adjustment of the patient bearing. No motor is provided for the drive in the embodiment shown in FIG. 6 since the transportation device 2 is configured to be driven by operating staff. As shown in FIG. 6 , the patient transportation device 2 contains an optical sensor 231 fastened on the underside at the front of the device and configured to detect floor markings. [0038] The use of floor markings is shown in more detail in FIGS. 7 and 8 . In addition to the front optical sensor 231 , the patient transportation device 2 shown in FIG. 7 optionally includes an additional optical sensor 234 that is likewise configured to detect floor markings. A marking 7 that specifies a transportation path to the medical instrument 1 is applied to the floor. The wheel positions of the central wheel 11 with the round configuration and of the coupled first wheel 12 , second wheel 13 , third wheel 14 , and fourth wheel 15 are corrected based on the detected line 7 , thereby providing automatic steering. Thus, the trolley 2 may be pushed by operating staff without manual steering. For embodiments containing an additional motorized drive, the trolley 2 may be automatically driven to the docking position without human intervention. [0039] FIG. 8 shows an alternative marking for the line shown in FIG. 7 . A schematic top view of an examination room is shown in FIG. 8 . A first area 1 is occupied by a medical modality. The patient transportation device 2 is positioned at the lower right-hand corner of FIG. 8 . The floor is subdivided into a plurality of sections 8 . Sections 8 of the floor that are relevant to the approach include markings 71 . The markings 71 are identified by sensors fastened to the underside of the patient transportation device 2 . Alternatively, the sensors may be fastened externally to the ceiling and used to control the wheels of the patient transportation device 2 . The individual markings 71 encode information about the position of the respective section 8 in relation to the docking point of the medical instrument 1 . [0040] FIG. 9 shows a patient transportation device 2 and a mobile medical instrument 1 (e.g. a mobile computed tomography instrument). The patient transportation device 2 and the mobile medical instrument 1 are configured for movement control using lines 7 on the floor that may be optically registered. The patient transportation device 2 and the mobile medical instrument 1 each include an optical sensor 231 configured to optically register the lines 7 . Moreover, each of the patient transportation device 2 and the mobile medical instrument 1 includes a central wheel 11 with control functionality, and each of the patient transportation device 2 and the mobile medical instrument 1 may include additional wheels, such as first wheel 12 , second wheel 13 , and third wheel 14 . In addition, the patient transportation device 2 and the mobile medical instrument 1 each include an ultrasound sensor 16 . The ultrasound sensor 16 may be used for measuring the distance. The distance established may in turn be used to initiate and control a docking procedure. By way of example, based on the distance, the velocity may be reduced, the docking interfaces may be activated, and the angle of approach may be adapted. [0041] Alternatively, or in addition, the distance information for controlling the docking procedure may also be encoded into the guide line 7 , as shown in more detail in FIG. 10 . The guide line or marking line 7 may include detectable marking bars, such as a sequence of equidistant bars that contain a first bar 72 and a second bar 73 , as shown in FIG. 10 . Distance information that triggers the docking is encoded by the distance between bars. Between the third bar 73 and the fourth bar 74 , bar spacing has increased in relation to the bar sequence. The increase in bar spacing is interpreted as a signal to initiate the docking procedure. For example, the velocity is reduced. The ultrasound sensors 16 are used to measure the distance, and the velocity is curbed as a function of the measured distance. The detection of the fourth bar 74 triggers the docking procedure. The next and final fifth bar 75 marks the end position for the docking procedure. [0042] While the present invention has been described above by reference to various embodiments, it should be understood that many changes and modifications may be made to the described embodiments. It is therefore intended that the foregoing description be regarded as illustrative rather than limiting, and that it be understood that all equivalents and/or combinations of embodiments are intended to be included in this description. [0043] It is to be understood that the elements and features recited in the appended claims may be combined in different ways to produce new claims that likewise fall within the scope of the present invention. Thus, whereas the dependent claims appended below depend from only a single independent or dependent claim, it is to be understood that these dependent claims may, alternatively, be made to depend in the alternative from any preceding claim—whether independent or dependent—and that such new combinations are to be understood as forming a part of the present specification.

1a

FIELD [0001] The present disclosure relates to electrical interconnects for implantable medical systems and devices, and, more particularly, to a co-fired ceramic electrical feedthrough assembly. INTRODUCTION [0002] The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent the work is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure. [0003] Miniaturized electrical feedthroughs are required for implantable medical devices (IMDs) that offer reduced functional volume in a small package while offering a high level of electromagnetic interference (EMI) protection. In conventional feedthrough technologies, EMI filtering is oftentimes accomplished by mounting chip-type capacitors or discoidal capacitors on the surface of an electrical feedthrough. This technology suffers from the disadvantage of increasing overall device volume while increasing lead interconnect length required to attach the termination of the capacitor to the hermetic pin assembly and grounding structure (typically the ferrule and a portion of the outer enclosure of a metallic IMD). Technologies are required that enable integration of EMI protection while improving the electrical performance in a very small, low-profile, miniaturized device structure. [0004] The present teachings provide a feedthrough assembly of the type used, for example, in implantable medical devices such as heart pacemakers and the like, wherein the feedthrough assembly is constructed of a plurality of layers of a non-conductive material with conductive traces present thereon. SUMMARY [0005] In various exemplary embodiments, the present disclosure relates to a multilayered feedthrough for an implantable medical device. The multilayered feedthrough includes a first edge and a second edge, and further includes a substrate having a first edge, a second edge, and a substrate length. A plurality of traces is formed on the substrate and extends along the substrate length. A plurality of contact pads is electrically coupled with the plurality of traces and extends to the first and second edges of the substrate. An insulator layer is formed on the substrate and the plurality of traces. The feedthrough further includes a ground plane layer. [0006] In various exemplary embodiments, the present disclosure relates to a multilayered feedthrough for an implantable medical device. The multilayered feedthrough includes a substrate having a first edge, a second edge, a substrate length, a first surface and a second surface opposite the first surface. A first plurality of traces is formed on the first surface and extends along the substrate length. A second plurality of traces is formed on the second surface and extends along the substrate length. A first plurality of contact pads is electrically coupled with the first plurality of traces and extends to the first and second edges of the substrate. A second plurality of contact pads is electrically coupled with the second plurality of traces and extends to the first and second edges of the substrate. A first insulator layer is formed on the first surface and the first plurality of traces. A second insulator layer is formed on the second surface and the second plurality of traces. The feedthrough further includes first and second ground plane layers. [0007] Further areas of applicability of the present disclosure will become apparent from the detailed description, the claims and the drawings. The detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the disclosure. BRIEF DESCRIPTION OF DRAWINGS [0008] The present disclosure will become more fully understood from the detailed description and the accompanying drawings, wherein: [0009] FIGS. 1 and 2 are isometric and exploded views, respectively, of a feedthrough assembly according to various embodiments of the present disclosure; [0010] FIG. 3 is an isometric view of a feedthrough assembly according to various embodiments of the present disclosure; [0011] FIG. 4 is an isometric view of a feedthrough assembly with an integrated transceiver according to various embodiments of the present disclosure; [0012] FIG. 5 is an isometric view of a feedthrough assembly with attached weld ring according to various embodiments of the present disclosure; [0013] FIG. 6 is an isometric view of a feedthrough assembly according to various embodiments of the present disclosure; and [0014] FIG. 7 is a cross-sectional view of the feedthrough assembly of FIG. 6 along line 7 - 7 . DESCRIPTION [0015] The following description is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. For purposes of clarity, the same reference numbers will be used in the drawings to identify similar elements. As used herein, the phrase at least one of A, B, and C should be construed to mean a logical (A or B or C), using a non-exclusive logical or. It should be understood that steps within a method can be executed in different order without altering the principles of the present disclosure. [0016] Referring now to FIGS. 1 and 2 , a feedthrough assembly 10 according to various embodiments of the present disclosure as illustrated. The feedthrough assembly 10 includes a plurality of layers. A substrate 14 includes a plurality of traces 15 formed on one or both sides of the substrate 14 . The substrate 14 can be made of any non-conductive material, for example, a high temperature co-fired ceramic or other ceramic material. The traces 15 can be formed on the substrate 14 by depositing a conductive material, such as platinum, gold or palladium, on the surface of substrate 14 such that they extend from one edge of the substrate to the other. Other methods of forming traces 15 can be utilized. [0017] The traces 15 can be formed on a first surface 144 a and/or a second surface 144 b of the substrate 14 . In various embodiments, integrated devices such as capacitors and/or filtering devices, e.g., SAW filters, can be formed (for example, by screening or photo lithography processes) on the substrate 14 or applied to the substrate 14 , and electrically connected to the traces 15 /contact pads 150 . For example, a SAW filter can be made from various materials, such as lithium niobate or lithium tantalate, and surface mounted to the substrate 14 . In this case, the insulator layer(s), which are described below, can encase the SAW filter to serve as a hermetic housing. [0018] An insulator layer 13 a , 13 b can be formed on the first and second surfaces 144 a , 144 b , respectively. The insulator layer can be formed of any non-conductive material, such as a high temperature co-fired ceramic or other ceramic material, similar to the substrate 14 . In some embodiments, the insulator layers 13 a , 13 b can be formed of any biostable and biocompatible materials, e.g., alumina, zirconia or a combination thereof. In various embodiments, the insulator layer 13 a , 13 b covers only a portion of the first and second surfaces 144 a , 144 b of the substrate 14 . For example, substrate edges 142 a , 142 b can remain exposed and not covered by insulator layer 13 a , 13 b . In this manner, traces 15 can be electrically connected to the IMD. [0019] Ground planes 12 a , 12 b can be formed on the insulator layer 13 a , 13 b in various embodiments. The ground planes 12 a , 12 b can be formed of any conductive material, such as platinum, gold, palladium or other metal. The ground planes 12 a , 12 b assist in shielding the traces 15 from stray electromagnetic interference, as well as minimizing interference between the traces 15 themselves. In various embodiments, the ground planes 12 a , 12 b can be formed of a continuous layer of conductive material covering the insulator layers 13 a , 13 b . In some embodiments, the ground planes 12 a , 12 b can be formed of a mesh or grid of conductive material covering the insulator layers 13 a , 13 b . Another insulator layer 11 a , 11 b can be formed on the ground planes 12 a , 12 b to insulate the ground planes 12 a , 12 b from the IMD. [0020] While the illustrated embodiments show the ground planes 12 a , 12 b to be formed on layers separate from substrate 14 , the present disclosure encompasses the formation of ground planes 12 a , 12 b in different configurations. For example, ground planes 12 a , 12 b can be formed on the substrate 14 and electrically insulated from traces 15 . Furthermore, ground planes 12 a , 12 b can be formed to substantially surround the substrate 14 and/or be oriented perpendicular to the first and second surfaces 144 a , 144 b of substrate 14 . Ground planes 12 a , 12 b can be connected to electrical ground potential in various ways, for example, by connection with one or more of the traces 15 , one or more of the contact pads 150 , with a weld ring 35 (described more fully below) or a combination thereof. For example only, ground planes 12 a , 12 b can be connected with traces 15 through the use of one or more vias formed in an insulator layers or layers 11 a , 11 b . The use of vias is described more fully below with respect to FIGS. 6-7 . [0021] The traces 15 of the feedthrough assembly 10 can extend to the edges 142 a , 142 b of the substrate 14 . In this manner, the traces 15 can be utilized as card edge connectors to mate with corresponding receiver slots (not shown) present, e.g., in the IMD. In various embodiments, contact pads 150 are included as part of the traces 15 . The contact pads 150 can have a larger surface area than traces 15 such that positive coupling between the traces and the associated circuitry of the IMD can be assured. In various embodiments, the traces 15 /contact pads 150 can extend around the edges 142 a , 142 b and be present on end surfaces 140 of the substrate 14 , as shown in FIG. 3 . The presence of the traces 15 , with or without contact pads 150 , on the end surfaces 140 can provide a more consistent coupling between the feedthrough assembly 10 and the receiver slots of the IMD. [0022] Referring now to FIG. 4 , a feedthrough assembly 20 with an integrated transceiver 26 according to various embodiments of the present disclosure as illustrated. Similar to feedthrough assembly 10 discussed above, the feedthrough assembly 20 includes a plurality of layers. A substrate 24 includes a plurality of traces 25 formed on one or both sides of the substrate 24 . The substrate 24 can be made of any non-conductive material, for example, a high temperature co-fired ceramic or other ceramic material. The traces 25 can be formed on the substrate 24 by depositing a conductive material, such as platinum, gold or palladium, on the surface of substrate 24 such that they extend from one edge of the substrate to the other. Other methods of forming traces 25 can be utilized. The traces 25 can be formed on a first surface 244 a and/or a second surface 244 b of the substrate 14 . The traces 25 can include contact pads, similar to that described above in regard to traces 15 and contact pads 150 . In various embodiments, integrated devices such as capacitors and/or filtering devices, e.g., SAW filters, can be formed on the substrate 24 and electrically connected to the traces 25 . [0023] An insulator layer 23 a , 23 b can be formed on the first and second surfaces 244 a , 244 b , respectively. The insulator layer can be formed of any non-conductive material, such as, a high temperature co-fired ceramic or other ceramic material, similar to the substrate 24 . In various embodiments, the insulator layer 23 a , 23 b covers only a portion of the first and second surfaces 244 a , 244 b of the substrate 24 . Substrate edges 242 a , 242 b can remain exposed and not covered by insulator layer 23 a , 23 b . In this manner, traces 25 can be electrically connected to the IMD. [0024] Ground planes 22 a , 22 b can be formed on the insulator layer 23 a , 23 b in various embodiments. The ground planes 22 a , 22 b can be formed of any conductive material, such as platinum, gold, palladium or other metal. The ground planes 22 a , 22 b assist in shielding the traces 25 from stray electromagnetic interference, as well as minimizing interference between the traces 25 themselves. In various embodiments, the ground planes 22 a , 22 b can be formed of a continuous layer of conductive material covering the insulator layers 23 a , 23 b . In some embodiments, another insulator layer 21 a , 21 b is formed on the ground planes 22 a , 22 b to insulate the ground planes 22 a , 22 b from the IMD. As described above, ground planes 22 a , 22 b can be connected to electrical ground potential in various ways, for example, by connection with one or more of the traces 25 , one or more of the contact pads 150 , with a weld ring 35 (described more fully below) or a combination thereof. [0025] The traces 25 of the feedthrough assembly 20 can extend to the edges 242 a , 242 b of the substrate 24 . In this manner, the traces 25 can be utilized as card edge connectors to mate with corresponding receiver slots (not shown) present, e.g., in the IMD. In various embodiments, the traces 25 can extend to around the edges 242 a , 242 b and be present on end surfaces 240 of the substrate 24 , as shown in FIG. 3 with respect to feedthrough assembly 10 . The presence of the traces 25 on the end surfaces 240 can provide a more consistent coupling between the feedthrough assembly 20 and the receiver slots of the IMD. [0026] An integrated transceiver 26 can be surface mounted on the substrate 24 , as illustrated in FIG. 4 . A signal-in trace 262 can be electrically connected to integrated transceiver 26 from the IMD. In this manner, integrated transceiver 26 can receive signals from the IMD. Integrated transceiver 26 can be further electrically connected to a signal-out trace 264 . Signal-out trace 264 can be electrically connected to an antenna or transmission/reception element (not shown). In this manner, integrated transceiver 26 can transmit information received from the IMD to, as well as receive information from, a remote device. Integrated transceiver 26 can be powered by power lines 266 formed as traces on substrate 24 . In various embodiments, transceiver 26 can include power lines and/or include signal-in and signal-out lines that are separate from the substrate 24 and traces 25 formed thereon, such as with a wire or ribbon bond. [0027] Referring now to FIG. 5 , a feedthrough assembly 30 according to various embodiments of the present disclosure as illustrated. Feedthrough assembly 30 can be substantially similar to feedthrough assemblies 10 and 20 described above. Weld ring 35 can be hermetically sealed to feedthrough assembly 30 . Weld ring 35 can be can be made of any biostable and biocompatible material, for example, titanium, niobium, tantalum or combinations thereof. Weld ring 35 can also be connected to the body of IMD such that there is a hermetic seal between IMD and feedthrough assembly 30 . The weld ring 35 can be coupled to the feedthrough assembly in various manners, such as by braze joint, diffusion bond, glass seal or a compression seal. [0028] Referring now to FIGS. 6 and 7 , a feedthrough assembly 200 according to various embodiments of the present disclosure as illustrated. The feedthrough assembly 200 includes a plurality of layers. A substrate 204 includes a plurality of traces 205 ( FIG. 7 ) formed on one or both sides of the substrate 204 . The substrate 204 can be made of any non-conductive material, for example, a high temperature co-fired ceramic or other ceramic material. The traces 205 can be formed on the substrate 204 by depositing a conductive material, such as platinum, gold or palladium, on the surface of substrate 204 . Other methods of forming traces 205 can be utilized. [0029] The traces 205 can be formed on a first surface 244 a and/or a second surface 244 b of the substrate 204 . In various embodiments, integrated devices such as capacitors and/or filtering devices, e.g., SAW filters, can be formed (for example, by screening or photo lithography processes) on the substrate 204 or applied to the substrate 204 , and electrically connected to the traces 205 /contact pads 250 . For example, a SAW filter can be made from various materials, such as lithium niobate or lithium tantalate, and surface mounted to the substrate 204 . In this case, the insulator layer(s), which are described below, can encase the SAW filter to serve as a hermetic housing. [0030] An insulator layer 203 a , 203 b can be formed on the first and second surfaces 244 a , 244 b , respectively. The insulator layer can be formed of any non-conductive material, such as a high temperature co-fired ceramic or other ceramic material, similar to the substrate 204 . In some embodiments, the insulator layers 203 a , 203 b can be formed of any biostable and biocompatible materials, e.g., alumina, zirconia or a combination thereof. In various embodiments, the insulator layer 203 a , 203 b covers the entire first and second surfaces 244 a , 244 b of the substrate 204 . [0031] Ground planes 202 a , 202 b can be formed on the insulator layer 203 a , 203 b in various embodiments. The ground planes 202 a , 202 b can be formed of any conductive material, such as platinum, gold, palladium or other metal. The ground planes 202 a , 202 b assist in shielding the traces 205 from stray electromagnetic interference, as well as minimizing interference between the traces 205 themselves. In various embodiments, the ground planes 202 a , 202 b can be formed of a continuous layer of conductive material covering the insulator layers 203 a , 203 b . In some embodiments, the ground planes 202 a , 202 b can be formed of a mesh or grid of conductive material covering the insulator layers 203 a , 203 b . Another insulator layer 201 a , 201 b can be formed on the ground planes 202 a , 202 b to insulate the ground planes 202 a , 202 b from the IMD. While the illustrated embodiments show the ground planes 202 a , 202 b to be formed on layers separate from substrate 204 , the present disclosure encompasses the formation of ground planes 202 a , 202 b in different configurations. For example, ground planes 202 a , 202 b can be formed on the substrate 204 and electrically insulated from traces 205 . Furthermore, ground planes 202 a , 202 b can be formed to substantially surround the substrate 204 and/or be oriented perpendicular to the first and second surfaces 244 a , 244 b of substrate 204 . As described above, ground planes 202 a , 202 b can be connected to electrical ground potential in various ways, for example, by connection with one or more traces 205 , one or more contact pads 250 , a weld ring 35 (described more fully below) or a combination thereof. [0032] In various embodiments, the traces 205 of the feedthrough assembly 200 do not extend to the edges of the substrate 204 . Instead, contact pads 250 are formed on a separate layer (in the illustrated example, insulator layer 201 a ) and electrically coupled with traces 205 . In this manner, the contact pads 250 can be utilized as card edge connectors to mate with corresponding receiver slots (not shown) present, e.g., in the IMD. The contact pads 250 can have a larger surface area than traces 205 such that positive coupling between the traces and the associated circuitry of the IMD can be assured. In various embodiments, the contact pads 250 can extend around the edges of the feedthrough assembly, similar to feedthrough assembly 20 illustrated in FIG. 3 . The presence of the contact pads 250 on the end surfaces can provide a more consistent coupling between the feedthrough assembly 200 and the receiver slots of the IMD. [0033] The traces 205 can be electrically coupled with the contact pads 250 by vias 255 . Vias 255 extend between the various layers of feedthrough assembly 200 , and can be formed of any conductive material, such as platinum, gold, palladium or other metal. In the illustrated embodiment, vias 255 extend through insulator layer 201 a , ground plane 202 a and insulator layer 203 a to couple contact pads 250 to traces 205 . In order to isolate the vias 255 from ground plane 202 a , apertures 257 are formed in ground plane 202 a through which vias 255 extend. In some embodiments, apertures 257 can be filled with an insulative material. In other various embodiments, apertures 257 can be hollow openings in the various layers through which vias 255 extend. [0034] In various embodiments of the present disclosure, feedthrough assembly 200 can include a weld ring 235 to hermetically seal feedthrough assembly 200 . Weld ring 235 can also be connected to the body of IMD such that there is a hermetic seal between IMD and feedthrough assembly 200 . The weld ring 235 can be coupled to the feedthrough assembly in various manners, such as by braze joint, diffusion bond, glass seal or a compression seal. Furthermore, in various embodiments, feedthrough assembly 200 can include an integrated transceiver, similar to feedthrough assembly 20 described above and illustrated in FIG. 4 . [0035] The broad teachings of the disclosure can be implemented in a variety of forms. Therefore, while this disclosure includes particular examples, the true scope of the disclosure should not be so limited since other modifications will become apparent upon a study of the drawings, the specification, and the following claims.

1a

This a continuation of application Ser. No. 07/885,789 filed May 20, 1992, now U.S. Pat. No. 5,221,253 which is a continuation of application Ser. No. 07/704,718, filed May 20, 1991 now U.S. Pat. No. 5,116,309, which is a continuation of application Ser. No. 07/301,090, filed Jan. 25, 1989, now abandoned. TECHNICAL FIELD OF THE INVENTION The present invention relates to a universal catheter inserted by conventional means which, once in place, functions as an external ureteral catheter which can be easily converted into an internalized ureteral catheter or stent. BACKGROUND OF THE INVENTION Ureteral catheters and stents are fundamental to the practice of Urology. These devices allow one to bypass and drain an obstructed ureter, determine urine output from a particular renal unit, and inject contrast to study the upper urinary tract. With the advent of newer methods to manage upper urinary tract stones (ESWL and ureteroscopy), the indications and use of ureteral catheters have and will continue to further increase. The ideal ureteral catheter should allow one to measure urine output from a particular renal unit, drain even tenaciously purulent material, allow injection of contrast for imaging and finally remain indwelling and self contained if longterm ureteral stenting or drainage is required. The presently available devices consist of external or internal ureteral catheters. Both types are usually passed through the ureteral meatus via a cystoscope, though they can be placed openly through different sites in the urinary tract. Externalized ureteral catheters drain the upper urinary tract and pass through the bladder, exiting the urethra and draining into an external collecting device. They allow drainage through ports and a central lumen and can be irrigated as needed to drain tenacious and obstructing material. By draining externally, the output from the involved renal unit can be carefully monitored. Contrast can be injected as needed to evaluate the upper tract. Unfortunately, these devices are not self contained and must be secured to an indwelling urethral catheter or they will migrate and be extruded by ureteral peristalsis. They therefore are not suitable for longterm outpatient care. With this objective in mind, internalized ureteral catheters were developed. The most commonly used type is a plastic catheter with a curl at both the proximal and distal ends; i.e. Double J catheter. The curls are straightened over a central stiffening wire in order to pass the stent, but are reformed when the stiffening wire is removed. The proximal curl prevents distal migration and thereby keeps the device in the renal pelvis. The distal curl is positioned in the bladder to allow completely internalized drainage. No urethral catheter is needed to secure this type of stent, making it ideal for outpatient management. U.S. Pat. No. 4,713,049 to Carter; 4,307,723 to Finney and 4,610,657 to Densaw all show this general approach while U.S. Pat 4,531,933 shows a variation of this concept by using helixes to replace hooks. The devices shown by these patents, however, have disadvantages. The urine output from the involved renal unit can not be recorded as only total urethral urine output can be recorded and this would include both kidneys. Also, since the distal end of the catheter is internalized, it is not possible to irrigate the tube should it become obstructed. Under these circumstances the obstructed catheter could be more detrimental than beneficial as it would occlude an already narrowed ureteral lumen. Since the ureteral catheter can become obstructed without any external indication, the situation can become dramatically acute before it is realized that the internalized stent is no longer serving its purpose. Lastly, as the stent is not externalized, contrast cannot be injected if needed to image the upper tract. A modification of the usual Double J catheter is available at present that allows injection of contrast via a small lumen--in the stiffening wire. This lumen however, is too small to allow reliable and accurate monitoring of urine output or drainage and irrigation of tenacious debris from the involved kidney. SUMMARY AND OBJECT OF THE INVENTION It is an object of the present invention to provide a combination catheter-stent that improves on the known prior art devices in that it has the advantages of both an externalized ureteral catheter and the advantage of an internalizable ureteral catheter once the necessity of externalized drainage or access is overcome. The device of the present invention comprises a Double J catheter with side ports along its proximal half. The proximal end is preferably closed. The distal one-third of the Double J catheter has a wider lumen diameter and is open ended and has consequently a somewhat wider outer diameter than the proximal end. This allows the distal end of the ureteral stent to accept the insertion of a rigid open-ended ureteral catheter. The distal end of the Double-J catheter terminates in a flange of greater outer diameter in order to allow retraction of the stiff ureteral catheter from the stent against an immobilizing abutting device. This rigid ureteral catheter is long enough to exit the urethra and can be drained by an external drainage system. When the necessity of outside drainage, contrast injection, or monitoring no longer exists, the rigid catheter can be easily disconnected from the flexible ureteral catheter. This allows the part of the stent in the bladder to return to its preformed curl or J shape and then function as a prior art stent of the Double J shape. DESCRIPTION OF THE DRAWINGS FIG. 1 is a view of the device as assembled for packaging. FIG. 2 is a view of the device after insertion and with the stiffening wire removed. FIG. 3 is a view of the stiff pusher needed for removal of the stiff ureteral catheter. FIG. 4 is a view of the device in its internalized (stent) form after detachment of the rigid ureteral catheter. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS In a preferred embodiment as shown in the figures the ureteral catheter 1 of the subject invention comprises a flexible plastic tube 2 having apertures 3 along the proximal end 4. The apertures extend between the outside of the catheter and the lumen 5. The catheter 1 may be constructed from any plastic material, preferably a soft flexible material provided with conventional indicating means 6 and is more preferably formed from a radiopaque silicone or silastic material of the type conventionally used for ureteral catheters or stents. The catheter should be marked with conventional centimeter markings to indicate the catheter's position. Only the proximal tip 14 of the ureteral catheter need be made of radiopaque material but it is preferable that the entire ureteral catheter including the flange be of radiopaque material to facilitate placement of the device. The distal one third 12 of the flexible plastic tube has an inside and outside diameter wider than that of the proximal end and has a flange 7 that begins about 1 centimeter proximal to the distal end. The distal end of the tube is open. A rigid open ended catheter 8 of the same diameter as the proximal end of the flexible tube is fitted through the flanged end and into the distal end of the flexible plastic tube. The rigid catheter is inserted far enough into the flexible tube to assure secure engagement of the flexible tube. The rigid catheter is held in place by reason of its close fit with the flexible tube. The flange design functions to allow the pusher 16 to disengage the rigid ureteral catheter from the flexible tube by abutting against and immobilizing the flexible tube while the rigid ureteral tube is disengaged. The outside flange diameter is larger than the internal diameter of the pusher. The flange is formed of the same material as the flexible tube. As shown in FIG. 1 a stiffening wire 9 is used to keep the flexible tube stiff while the catheter as a unit is being inserted. The stiffening wire can be passed through a rubber stopper 10 within the distal end of the rigid catheter. The stopper prevents the wire from receding from the distal end of the ureteral catheter during insertion. When the apparatus has been properly placed, withdrawing the rigid wire will also withdraw the stopper. Portions adjacent each of the ends 11 and 12 of the flexible tubular member 2 are formed and set in the shape of gentle curls 13 and 14 as shown in FIG. 4. The insertion of the stiff catheter 8 into the flanged end of the flexible stent straightens the curl or J 14 and holds it in straight alignment as shown in FIG. 2. A stiffening wire 9 straightens the device including the proximal end 11 of the Double J catheter for easy insertion. A thread or suture 15 can be attached to the distal end of the flexible catheter in order to allow easy removal of the device by pulling on the suture. The rigid ureteral catheter 8 is formed of material conventionally used for such catheters and is preferably a stiff polymeric material with a hard smooth surface that glides such as polytetrafluoroethylene or nylon. The rigid ureteral catheter is marked near its distal end. With the rigid ureteral tube inserted in the flexible catheter, the length of rigid tubing between the flange and the marking 17 is equal to the length of the "pusher" 16. The length of the "pusher" is such that when passed over the rigid ureteral catheter, the flange of the flexible tube will be abutted just as the marking on the rigid ureteral catheter is visualized. This allows the operator to know when the flanged end of the flexible ureteral catheter is immobilized prior to extraction of the rigid ureteral catheter. The device is sterilely packaged assembled. Different sizes and diameters can be made available with component sizes scaled appropriately. The sizes, lengths and diameters of the various elements are those conventionally used in the art. As an example of procedure, consider a #7 French Universal Stent. The proximal two thirds of the catheter has a size 7 French lumen and the distal third of the catheter has a size 8.5 French lumen. The distal end of the silastic catheter has a size 9 French flange that begins 1 centimeters proximal to the distal end. The proximal J is straightened over a O.038 mm stiff guide wire. This wire also passes through a rigid plastic 7 French ureteral catheter which is inserted into the 8.5 French distal third of the silastic catheter. The wire exits the distal part of the rigid ureteral catheter and is held in place securely by a detachable rubber stopper. With the wire in place, the proximal end of the J catheter is straightened and can be inserted through a #22 French cystoscope and passed up in the ureteral orifice to the renal pelvis. The wire then is removed along with the rubber stopper, allowing the proximal curl to form. The rigid ureteral catheter exits through the urethra and the system can be used for an immediate imaging study if needed. To continuously drain the kidney (i.e. to monitor urine output, drain purulent debris, or irrigate to free the system of purulent material) one can secure the rigid ureteral catheter to an indwelling urethral catheter and attach the rigid ureteral catheter to an external drainage bag. Once the patient is stable and there is no more need for external drainage, the stent can be internalized. The rigid catheter is then completely cleansed with a topical disinfectant and sterile gloves are donned. Packaged separately is a sterile size 8.5 French "pusher" (open ended tube) which then is lubricated and passed over the rigid ureteral catheter until resistance is met as it abuts the flanged distal end of the silastic ureteral catheter. The operator will also know that the flanged distal end of the silastic ureteral catheter has been abutted because the marking on the rigid ureteral catheter will be visualized. Then gently pull the rigid catheter through the pusher, holding the pusher in place. Then gently extract the pusher from the urethra. This will allow the distal end of the silastic catheter to form a curl in the bladder and thereby leave a completely internalized stent. The thread or suture can be left attached to the distal end of the silastic catheter to allow easy extraction through the urethra. If desired, the stiffening wire can be inserted first using conventional means. After cutting off the proximal tip of the stent, the stent-ureteral catheter device is passed over the wire in order to insert the catheter combination. Also if desired, various adapters can be secured to the external end of the stiff ureteral catheter in order to permit irrigation, application of contrast solutions to the renal cavity etc. The thread or suture is preferably of a synthetic polymer with opaque characteristics. It is attached to the stent at any convenient location. The advantages of the above described device are many. The materials of construction are conventional. The device can be packaged intact and ready to insert. The various elements can be formed in a variety of sizes, lengths and diameters with component sizes scaled appropriately. The device obviates the need for separate externalized and internalized ureteral catheters. Further, the device is simple in operation and makes use of concepts and designs proven to be effective and reliable. The device as described in the preferred embodiment specifies insertion of the rigid catheter into the distal third of the flexible tube. However, it is only necessary that the rigid tube be held securely in the stent until it is removed. Further, it can be seen that the specific type of connection described is not critical. Any method of connection that allows the apparatus to function as described is contemplated. Also, as described, the flange, in connection with the stiff pusher, serves only to hold the apparatus in place while the stiff catheter is removed. Any structure that serves to prevent the catheter from being pulled out of the renal cavity when the stiff catheter is removed is contemplated. It will be readily apparent to those skilled in the art that a number of modifications and changes can be made without departing from the spirit of the invention. Therefore, it is to be understood that the scope of the invention is not to be limited by the foregoing description, but only by the claims.

1a

BACKGROUND OF THE INVENTION Traction devices which have been used for years by the medical profession are either expensive devices employed in hospitals or cumbersome devices employing weights which may be used in one's home. SUMMARY OF THE INVENTION It is an object of the present invention to provide a portable, simple, easy to use, and inexpensive traction device which may be used in hospitals, a physican's office, or in the patient's home. It is a further object of the present invention to provide a traction device that is readily adjustable and that employs a quick release device to enable the patient to release the traction. In the preferred embodiment, the traction device comprises a frame adapted to fit about a patient's body. The frame has two telescoping side members and two end members, the latter of which have connecting means adapted to be coupled to the patient's body at two different positions. Means is provided for biasing the telescoping members outward to apply tension to the patient's body. Means is provided to allow the tension to be varied depending upon the need. In addition a quick release device operable by the patient is provided to release the tension. BRIEF DESCRIPTIO OF THE DRAWINGS FIG. 1 illustrates the traction device of the present invention fitted about and to a patient; FIG. 2 is an enlarged view of the traction device of FIG. 1 with the different type of lower body harness attached thereto; FIG. 3 is an enlarged partial cross section of a portion of the device of FIGS. 1 and 2; and FIG. 4 illustrates in detail the quick release device employed in the traction device of FIGS. 1 and 2. DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, the traction device of the present invention comprises a rectangular shaped frame 21 adapted to fit about a patient's body while lying down on a bed or the like as seen in FIG. 1. The frame 21 is separate from the bed and forms no part thereof. It comprises two telescoping side members 23 and 25 and two end members 27 and 29. Side member 23 comprises a hollow tubular member 31 having a tubular member 33 of smaller diameter slideably fitted within end member 31 and extending out of its end 31A. Similarly, side member 25 comprises a hollow tubular member 35 having a tubular member 37 of smaller diameter slideably fitted within end member 35 and extending out of its end 35A. The end 33A and 37A of members 33 and 37 are press fitted within the openings of elbows 39 and 41 respectively. The member 27 is a tubular member press fitted within the other openings of elbosw 39 and 41. Eye-bolts 43 and 45 are attached to end member 27 for holding harnesses 47 and 49 for attaching the patient's feet to end member 27 as shown in FIG. 1, or for holding a corset type harness 51 for attaching the patient's hips to end member 27 as shown in FIG. 2. The ends 31B and 35B of members 31 and 35 are press fitted within first openings of hollow of T-members 63 and 65 respectively. The end member 29 is a tubular member and is press fitted within the intermediate openings of T-members 63 and 65. An eye-bolt 67 is attached to end member 29 for holding a harness 69 for attaching the patient's head to end member 29 as shown in FIG. 1 or for holding a different type of harness for attaching the shoulders or the chest of the patient's body to end member 29. Two short hollow tubular members 71 and 73 are permently attached within the other openings of T-members 63 and 65 respectively. Removable end caps 75 and 77 are threaded to the ends of members 71 and 73. Aligned openings extend through members 71, 63 and 31 and through members 73, 65, and 35. Located within tubular members 31 and 35 are biasing springs and inserts for normally biasing members 33 and 37 outward from members 31 and 35 whereby ends 27 and 29 are normally biased away from each other for applying traction or tension to the patient's body. Each pair of biasing springs and inserts for members 31 and 35 are the same. Reference will be made to FIG. 3 for a description of the biasing spring and insert employed in tubular member 31. In this Figure, the member 31 is shown from a position opposite that of FIGS. 1 and 2 such that slideable member 33 is shown on the left rather than on the right. The biasing spring is a compression spring identified at 81 and the insert is a tubular member identified at 83. Tubular spacers 85 may be located between spring 81 and the end of insert 83. A similar spring 81 and insert 83 will be located in tubular member 35. If spacers 85 are located in tubular member 31, similar spacers will be located in tubular member 35. In FIG. 2 the springs 81, spacers 85 and inserts 83 are shown in dotted form. The inserts 83 are slideably fitted in tubular members 31 and 35 and have ends adapted to engage the end caps 75 and 77 and opposite ends adapted to engage the end of springs 81 or spacers 85 which engage the springs 81 when the patient's lower and upper portions of his body are attached to end members 27 and 29. Thus, when the patient's upper and lower portions of his body are connected to ends 27 and 29, compression springs 81 of the tubular members 31 and 35 engage the ends of members 33 and 37 and the ends of spacers 85 or the ends of inserts 83 and urge the members 33 and 35 and inserts 83 in opposite directions. Since the opposite ends of inserts 83 engage end caps 75 and 77, the ends of members 27 and 29 will be urged in opposite directions to apply traction or tension to the patient's body. The compression strength of each of springs 81 is the same and is predetermined. The amount of traction or tension applied to the patient's body depends on the length of the insert 83 and/or the presence or absence of spacers 85. This is determined solely by the physician or other properly trained practitioner and may be measured by a spring operated scale 87 which is attached to the harness 69. For a patient of a given size, the amount of traction may be increased by using longer inserts 83 or by the use of one or more spacers 85. The traction may be decreased by using shorter inserts 83 or by removing the spacers 85. The inserts 83 and spacers 85 may be inserted into or removed from the tubular members 31 and 35 through members 71 and 73 by removing the end caps 75 and 77. For convenience and safety, a traction release operable by the patient is provided. It is coupled to the harness 69 and is identified at 91 in FIG. 4. The device 91 comprises a strap 93 having one end coupled to the end of member 29 by way of the scale 87 and an opposite end releaseably coupled to a spring biased clip 95 which in turn is connected to a bar 97 of the hearness 69. A strap 99 is connected to the bar 97 and is positioned around the patient's chin as shown in FIG. 1 or under the patient's arms if the harness is of a different type, for allowing the upper portion of the patient's body to be attached to the end member 29. The clip 95 comprises two plates 101 and 103 pivotally coupled together by way of a pivot pin 105. Plate 101 has an opening 107 formed therethrough for receiving the free end 93A of the strap 93. Plate 103 has teeth 109 formed at one end which are urged against the strap 93 to secure it to the clip 95. The clip 95 may be opened by moving ends 101A and 103A toward each other. The patient is fitted to the frame by first attaching the lower portion of the body to the end member 27 by way of the selected harness 47, 49 or 51. Having determined the desired length of the inserts 83 and the use or absence of the spacers 85 for a given patient, the harness 69 is attached to the patient and clip 95 is opened and the free end 93A of the strap 93 is inserted through the opening 107. The free end 93A of the strap is then pulled toward member 29 until the desired tension is reached as shown by scale 87. At this point, the clip 95 is closed to allow the teeth 109 to bite into the strap to secure the strap to the clip. If the patient desires to release the traction, he merely has to reach behind him and open the clip 95 with his hand. Thus, it can be understood that the traction device of the present invention is readily adjustable to accommodate a wide variety of patient sizes and shapes. In the preferred embodiment, the tubular components of the device are formed of PVC whereby they are light weight. Since the members 31, 35 and 29 are press fitted into T-members 63 and 65 and members 33, 37 and 27 are press fitted to elbows 39 and 41, the frame may be readily disassembled to permit transportation in a light weight, compact package. After use, it also may be disassembled completely for proper cleaning and sterilization if desired. Since the device is simply constructed, assembly may be readily accomplished. The device will permit the physician or other practitioner to prescribe the proper amount of traction and to adjust the device so that the patient or other unskilled individual cannot inadvertently apply more than the desired amount of traction. The scale 87 permits the proper amount of traction to be applied, as prescribed by a physician or other properly trained practitioner. It can also be understood that the traction device will accommodate a wide variety of standard harness configurations that will permit the device to be attached to the patient. It is thus capable of applying varying degrees of traction to the cervical and lumbar vertebra, to the pelvic area, and to the lower extremities. The device is equally suitable for use in a hospital, a physician's office, or in the patient's home. Since it is simple, it is easily understood by the patient's so that they may make use of the device upon their own person or with the help of other persons. The harnesses 47, 49 and 51 are lace up type harnesses whereby the patient may himself connect his lower portions to the frame 27 or with the help of others. The patient himself or with the help of others may readily use the upper harness 69 to attach his upper body to the end member 29 as described previously. Also as described previously, the patient may release the traction himself in the event that he desires to do so.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/972,494 filed Mar. 31, 2014, the entire contents of which is herein incorporated by reference. FIELD OF THE INVENTION This invention relates to metering apparatuses for agricultural product. BACKGROUND OF THE INVENTION Implements for distributing agricultural product (e.g. seed, fertilizer, etc.) in a field are generally towed behind a tractor or other vehicle. Such implements include one or more ground engaging tools for opening the ground to provide a path in which the agricultural product is deposited. Deposition is accomplished by a system for distributing the agricultural product generally from a single large bin through various lines and ports to be finally deposited on the ground through an outlet port. Following the deposition of the agricultural product, packers cover the deposited agricultural product with soil. An air cart is one system for distributing agricultural product. An air cart comprises one or more large bins for holding one or more different types of agricultural product, an airflow source (e.g. a fan) and lines or hoses through which agricultural product is carried by the airflow to outlets located at or near the ground engaging tools of the implement. The product passes through the outlet to be deposited on the ground. There are typically a plurality of lines, hoses and ports, one outlet port associated with each ground engaging tool in order to apply product in a regular pattern to large areas of land in a single pass of the implement. In air carts, proper metering of agricultural product into the airflow is desired to regularize the amount of product delivered to the outlets over time in order to reduce over- or under-deposition of the product in a particular area. Air carts traditionally employed single auger hoppers in which one very large (1-2 feet long) rotating auger distributed agricultural product from the hopper into a single airstream. Such arrangements are still used today by some manufacturers, for example Amity. Single auger air carts suffer from a number of problems. First, either the auger is on or off so agricultural product is either delivered across the entire implement or not delivered at all anywhere on the implement. Thus, fine control over sectional metering is impossible. Second, agricultural product must be metered into an initial large 5″ line, and then split into 2.5″ lines followed by another split into 1″ lines. This creates more complexity as secondary splitters are required and provides less control in how product is transported around the distribution system. Third, it is impossible to distribute more than one kind of product at the same time. Fine sectional control is desirable because passage of the implement over soil that has already received agricultural product (e.g. the headland) would result in waste of product; therefore, it is desirable to shout off distribution to parts of the implement that are passing over such soil. In an effort to solve this problem, metering apparatuses are preferably equipped with sectional shutoff capabilities to selectively stop deposition of product at parts of the implement passing over already serviced soil. Metering apparatuses for this purpose are known in the art, for example as disclosed in US 2012/0325131 published Dec. 27, 2012, U.S. Pat. No. 8,132,521 issued Mar. 13, 2012, U.S. Pat. No. 8,141,504 issued Mar. 27, 2012 and U.S. Pat. No. 8,196,534 issued Jun. 12, 2012, the entire contents of all of which are herein incorporated by reference. Such metering apparatuses generally involve a meter roller assembly in which a plurality of meter rollers is rotated on a common shaft, the rollers rotating around a transverse axis relative to the motion of the distribution implement. In such an arrangement, sectional control of the meter rollers to prevent distribution of product to certain parts of the implement is problematic. Complicated clutching mechanisms or inefficient gating mechanisms have all been used as described in the aforementioned prior art apparatuses. Recent developments have provided metering apparatuses for distributing an agricultural product having a plurality of metering elements coupled to a drive input, each of the metering elements rotating around different axes of rotation. Examples are described in commonly owned U.S. Ser. No. 14/198,584 filed Mar. 5, 2014 and in U.S. Pat. No. 8,434,416 issued May 7, 2013, the entire contents of both of which are herein incorporated by reference. Sectional control may be accomplished by shutting off flow of agricultural product at individual metering elements through the use of clutches or individually driven metering elements. However, there remains a need for metering apparatuses for agricultural product having different means for sectional control of product distribution in a field. SUMMARY OF THE INVENTION There is provided a metering apparatus for distributing an agricultural product, comprising: a meterbox configured for association with a hopper for receiving agricultural product from the hopper; a rotatable metering element disposed within a chamber in the meterbox, the rotating metering element configured to deliver the agricultural product at a regulated rate from the hopper through the chamber to a product distribution line; and, stopping means for selectively stopping delivery of the agricultural product to the product distribution line, the stopping means comprising a reversibly inflatable seal between the metering element and an outlet to the distribution line, a reversible seal formed by contact between the metering element and an inlet from the hopper to the chamber, or a disengagement structure for disengaging the agricultural product from the metering element while the metering element continues to rotate. There is further provided an agricultural product distribution system comprising a metering apparatus of the present invention. The metering apparatus and distribution system have a longitudinal axis in the direction of forward (or backward) motion of an agricultural product distribution implement as it is being towed across the ground. The longitudinal axis runs from front to rear (or rear to front) of the metering apparatus and distribution system. The metering apparatus and distribution system have a transverse axis that is perpendicular to the longitudinal axis and runs side to side (left to right or right to left) of the metering apparatus and distribution system. The metering apparatus comprises a rotatable metering element disposed within a chamber in the meterbox. Rotatable metering element may include, for example, belt meters, meter rollers and the like. Meter rollers may include smooth output rollers, pegged output rollers, fluted output rollers, high output rollers, etc. There may be one or a plurality of the metering elements in the chamber arranged in one or a plurality of rows. The metering elements may be driven on a common shaft, or one or more of the metering elements may be driven on one or more separate shafts. In one embodiment, all of the metering elements may be driven on a single shaft. The number of metering elements per meterbox is preferably three or more, four or more or five or more. One or more, two or more or three or more rows of metering elements may be used. The numbers will depend to an extent on the size of the distribution implement. From 1 to 5 rows and from 5 to 15 metering elements per row are preferred. For many applications, 1 row with from 6 to 12 metering elements in one meterbox is suitable. One or more drive inputs may be used to drive rotation of the metering elements. The drive input may be derived from any suitable source of mechanical power, for example a motor or motors. Motors include electric motors, hydraulic motors, stepper motors, internal combustion engines, etc. In some cases the power take-off from a towing vehicle may be used to drive the metering elements. In other cases, a ground driven wheel may be used to provide rotational movement of the drive input by virtue of forward travel of the implement along the field. The drive input may be coupled to the metering elements by any coupling means suitable for the type of drive input and the arrangement of the metering elements on drive shafts. Couplings include, for example, belt on pulley, chain on sprocket, directly linked drive shaft, etc. The metering elements may be disposed in the meterbox collectively in a single chamber, individually within individual chambers or some combination thereof. The chamber may comprise one or more openable and closeable access ports for permitting access into the chamber without removing any metering element. Access permits servicing the metering apparatus without necessarily needing to take the time to remove the metering elements. In some embodiments, the access ports may also permit individual servicing of each metering element, for example individual cleaning or, if needed or desired, individual change out of a metering element without needing to disturb the other metering elements. The meterbox may further comprise an inlet for receiving agricultural product from the hopper and an outlet for delivering metered product to a product distribution line, for example an air distribution line in the case of air carts. There may be a plurality of inlets and/or outlets. Each metering element may be associated with one inlet, or one inlet may provide product to more than one metering element. Each metering element may be associated with one outlet, one metering element may be associated with more than one outlet, one outlet may be associated with more than one metering element of some combination thereof. The meterbox may be separated from or integrated within the hopper. The hopper and/or meterbox may be equipped with other standard features, for example, covers, canopies and/or agitator bars. The stopping means permits selective delivery of the agricultural product to the product distribution line. Being able to select whether the product distribution line will receive product at any given time permits sectional control of product delivery to the field. It is desirable to avoid multiple applications of agricultural product to the same area of the field, both for reducing product waste and also for improving product performance by providing it at the correct dosage. Furthermore, where the metering apparatus comprises a plurality of metering elements, it is possible to configure the stopping means to prevent delivery of product from one or more metering elements but not others. This permits an operator to sequentially or otherwise selectively prevent product delivery from individual or groups of metering elements when approaching an irregular boundary, such as a water hole, in a field while towing the distribution implement. Because the implement must be towed to avoid the irregular boundary, parts of the implement will be towed over areas of the field in which agricultural product has already been deposited. By selectively determining the rate of application of agricultural product across a width of the distribution implement, the present invention permits control over where the agricultural product will be deposited, thus greatly reducing product waste and improving distribution patterns of the product in the field. The stopping means may comprise a reversibly inflatable seal between the metering element and an outlet to the distribution line. The reversibly inflatable seal may comprise a surface that engages an inner surface of the chamber when the inflatable seal is inflated to block passage of the agricultural product from the chamber to the outlet. The surface of the inflatable seal may comprise a protrusion, and the protrusion may abut a floor of the chamber proximate the outlet when the inflatable seal is inflated. The inflatable seal may comprise a base secured to a wall of the chamber. When there is a plurality of metering elements, there may be a single inflatable seal for all the metering elements, one inflatable seal for each metering element or one inflatable seal for a few of the metering elements and other inflatable seals for the other metering elements. For individual control over product flow from individual metering element, one inflatable seal per metering element is preferred. Furthermore, the metering apparatus may comprise one or more conduits for recycling agricultural product from the chamber to the hopper when the inflatable seal is inflated. The stopping means may comprise a reversible seal formed by contact between the metering element and an inlet from the hopper to the chamber. The seal may be formed and unformed by moving the metering element between a lowered unsealing position and a raised sealing position. The movement may involve a simple translation of the metering element up and down, or may involve a pivoting motion of the metering element. In one embodiment, the metering element comprises a meter roller. The meter roller may comprise an arcuate surface that protrudes into the hopper through the inlet when the meter roller is in the raised sealing position, whereby the arcuate surface abuts the hopper on each side of the inlet to seal the inlet to prevent flow of agricultural product from the hopper to the chamber. The meter roller may be pivotable between the raised sealing position and the lowered unsealing position to open and close a gap between the arcuate surface and the hopper at only one side of the inlet. The gap has a size that may be adjusted to vary the rate at which the agricultural product is delivered to the product distribution line. In another embodiment, the metering element comprises a belt meter. The belt meter may comprise an endless belt having an outer surface that abuts the hopper on each side of the inlet when the belt meter is in the raised sealing position to seal the inlet and prevent flow of agricultural product from the hopper to the chamber. The belt meter may be pivotable between the raised sealing position and the lowered unsealing position to open and close a gap between the endless belt and the hopper at one side of the inlet and to downwardly incline the belt meter toward the one side of the inlet when the belt meter is in the lowered unsealing position. The gap has a size that may be adjusted to vary the rate at which the agricultural product is delivered to the product distribution line. The stopping means may comprise a disengagement structure for disengaging the agricultural product from the metering element while the metering element continues to rotate. The disengagement structure permits disengagement of the agricultural product from the metering element while the metering element continues to rotate; however, in addition to using the disengagement structure, the metering element may also be stopped, if desired, to further ensure that metering of the agricultural product is stopped. In one embodiment, the disengagement structure may comprise moving the agricultural product away from the metering element. Moving the agricultural product may involve lowering, raising and/or laterally translating a structure that contains the agricultural product. For example, the chamber may comprise a chamber floor and the disengagement structure may comprise the chamber floor movable between a product engaging position and a product disengaging position. Preferably, the product engaging position comprises a raised position and the product disengaging position comprises a lowered position. One of a variety of arrangements may be utilized to facilitate moving the chamber floor. In one arrangement, the chamber may comprise a trough portion secured by a hinge to the hopper or an immovable part of the meterbox, whereby the trough portion may comprise the chamber floor and the trough portion may swing on the hinge between a raised and lowered positions. The meterbox may comprise an inclined portion having a lip over which the agricultural product flows to reach an outlet to the product distribution line, and an inlet guard depending down from the hopper into the chamber such that an end of the inlet guard is at a level low enough to prevent continuous agricultural product flow over the lip. In one embodiment, the inlet guard is at the same level as or lower than the lip. The chamber floor may comprise an inclined portion that slidably abuts the inclined portion of the meterbox to form a seal to prevent agricultural product from exiting the chamber without flowing over the lip. In another arrangement, the chamber may comprise a trough portion secured to a translatable product conduit. The product conduit may be configured to permit agricultural product to flow from the hopper to the trough portion. An actuator, for example a hydraulic cylinder, an electrical actuator, a spring or a combination thereof, may be utilized to effect translation of the product conduit and trough portion. In one embodiment, a hydraulic actuator may be utilized to selectively translate the product conduit and trough portion, while a compression spring may be utilized at the same time to continuously bias the product conduit and trough portion toward the product engaging position. The conduit may be translated in any direction, for example vertically, laterally or at an angle to the lateral and/or vertical directions. Preferably, the conduit is translated vertically, or at an angle of up to 45° to the vertical and horizontal directions. In another embodiment, the metering element may comprise a meter roller and the disengagement structure may comprise the meter roller movable between a lowered product engaging position and a raised product disengaging position. The chamber may comprise a chamber floor comprising an inclined portion having a lip over which the agricultural product flows to reach an outlet to the product distribution line, and an inlet guard depending down from the hopper into the chamber such that an end of the inlet guard is at a level low enough to prevent continuous agricultural product flow over the lip. In one embodiment, the inlet guard is at the same level as or lower than the lip. Raising and lowering of the meter roller may involve a simple translation of the meter roller up and down, or may involve a pivoting motion of the meter roller. The meter roller may be pivoted between the raised and lowered positions in any suitable fashion, for example by an actuator (e.g. a linear actuator or a hydraulic cylinder). The meter roller may be connected to a gear and the gear intermeshed with a driven sprocket. Driving the sprocket drives the meter roller. Where more than one meter roller is present, one or more drive axles may be used to drive the sprockets and hence the meter rollers. Agricultural product may include, for example, seed, fertilizer, pesticide, etc. Different types of agricultural product may be distributed separately or at the same time. It is a particular advantage that one implement can have multiple hoppers, each hopper containing different agricultural product and equipped with metering elements arranged in accordance with the present invention for simultaneous distribution of different agricultural product while having separate sectional control over the distribution of each type of agricultural product. The metering apparatus may be used in conjunction with an agricultural product distribution system, for example an air cart where airflow is used to transport agricultural product through various air lines (e.g. hoses) and ports to outlet ports through which the product is deposited in soil. In such an air cart arrangement, the metering apparatus meters agricultural product into an airstream that carries the product to other parts of the distribution implement. Each airstream is generally carried in separate air lines. There may be one or more than one metering element per airstream, so a single airstream may receive product from one or more than one metering element. Further features of the invention will be described or will become apparent in the course of the following detailed description. It will be apparent that certain features while described in the context of one embodiment are also applicable in the context of any other embodiment, and that the detailed description is meant to illustrate particular embodiments and not limit the applicability of individual features only to the embodiments in which the features are described. BRIEF DESCRIPTION OF THE DRAWINGS In order that the invention may be more clearly understood, embodiments thereof will now be described in detail by way of example, with reference to the accompanying drawings, in which: FIG. 1A depicts a first embodiment of a metering apparatus where flow of agricultural product to an air distribution line is blocked by an inflatable balloon between a meter roller and an outlet to the air distribution line. FIG. 1B depicts the metering apparatus of FIG. 1A where the inflatable balloon is deflated to permit flow of agricultural product to the air distribution line. FIG. 2A depicts a perspective view of a second embodiment of a metering apparatus where flow of agricultural product to an air distribution line is blocked by a meter roller protruding into a hopper and forming a seal with the hopper at an inlet from the hopper into a metering chamber. FIG. 2B depicts a side view of FIG. 2A . FIG. 2C depicts an end view of FIG. 2A . FIG. 2D depicts the metering apparatus of FIG. 2A where the meter roller has been pivoted away from the inlet to permit flow of agricultural product from the hopper to the metering chamber and then to the air distribution line. FIG. 2E depicts a side view of FIG. 2D . FIG. 2F depicts an end view of FIG. 2D . FIG. 3A depicts a perspective view of a third embodiment of a metering apparatus where flow of agricultural product to an air distribution line is blocked by a belt of a belt meter forming a seal with a hopper at an inlet from the hopper into a metering chamber. FIG. 3B depicts a side view of FIG. 3A . FIG. 3C depicts a top view of FIG. 3A . FIG. 3D depicts the metering apparatus of FIG. 3A where the belt meter has been pivoted away from the inlet to permit flow of agricultural product from the hopper to the metering chamber and then to the air distribution line. FIG. 3E depicts a side view of FIG. 3D . FIG. 3F depicts a top view of FIG. 3D . FIG. 4A depicts a perspective view of a fourth embodiment of a metering apparatus where flow of agricultural product to an air distribution line is prevented by lowering the agricultural product in a metering chamber away from a continuously turning meter roller to disengage the agricultural product from the meter roller. FIG. 4B depicts a side view of FIG. 4A . FIG. 4C depicts an end view of FIG. 4A . FIG. 4D depicts the metering apparatus of FIG. 4A where the agricultural product is raised in the metering chamber to engage the meter roller to permit metering of the agricultural product to the air distribution line. FIG. 4E depicts a side view of FIG. 4D . FIG. 4F depicts an end view of FIG. 4D . FIG. 5A depicts a perspective view of a fifth embodiment of a metering apparatus where flow of agricultural product to an air distribution line is prevented by raising a continuously rotating meter roller away from the agricultural product in a metering chamber to disengage the meter roller from the agricultural product. FIG. 5B depicts a side view of FIG. 5A . FIG. 5C depicts a top view of FIG. 5A . FIG. 5D depicts the metering apparatus of FIG. 5A where the meter roller is lowered in the metering chamber to engage the meter roller with the agricultural product to permit metering of the agricultural product to the air distribution line. FIG. 5E depicts a side view of FIG. 5D . FIG. 5F depicts a top view of FIG. 5D . FIG. 6A depicts a perspective view of a sixth embodiment of a metering apparatus where flow of agricultural product to an air distribution line is prevented by pivoting a continuously rotating meter roller to raise the meter roller away from the agricultural product in a metering chamber to disengage the meter roller from the agricultural product. FIG. 6B depicts an end view of the metering apparatus of FIG. 6A . FIG. 7A depicts a perspective view of a seventh embodiment of a metering apparatus where flow of agricultural product to an air distribution line is prevented by moving the agricultural product in a metering chamber away from a meter roller to disengage the agricultural product from the meter roller. FIG. 7B depicts a side view of FIG. 7A in a configuration for permitting product flow to the air distribution line. FIG. 7C depicts a side view of FIG. 7A in a configuration for preventing product flow to the air distribution line. DESCRIPTION OF PREFERRED EMBODIMENTS With reference to FIG. 1A and FIG. 1B , a metering apparatus 100 is shown in which flow of agricultural product from a hopper 150 to an air distribution line 190 may be blocked by an inflatable balloon 105 between a meter roller 110 and an outlet 130 to the air distribution line 190 . The metering apparatus 100 comprises the meter roller 110 , in this case a pegged meter roller although any suitable meter roller (e.g. a smooth roller, fluted roller or high output roller) may be employed, disposed within a metering chamber 106 of a meterbox 107 . The metering chamber 106 is in communication with the hopper 150 via an inlet 115 so that the agricultural product in the hopper 150 can flow into the metering chamber 106 . The agricultural product collects on a floor 109 of the metering chamber 106 and engages with the meter roller 110 . As seen in FIG. 1B , when the balloon 105 is deflated, rotation of the meter roller 110 , in this case clockwise rotation, meters the agricultural product at a regulated rate up and over a lip 112 proximate an end of an inclined portion 113 of the floor 109 to exit the metering chamber 106 through the outlet 130 into the air distribution line 190 , which carries the agricultural product to product application outlets for distribution in a field. When it becomes desirable to cut off flow of the agricultural product to the air distribution line 190 , the balloon 105 may be inflated by directing air flow (or some other gaseous or liquid medium) into the balloon 105 . Air for inflating the balloon may be provided by the same or different source as the air for the air distribution line. For example, an air compressor or other type of compressive device may be provided to inflate the balloon with any suitable gaseous or liquid medium. Decompression may be accomplished by letting the medium vent into the environment. The balloon naturally retracts and decompresses to its deflated state. The balloon 105 comprises an external knob 104 that engages and seals against the lip 112 of the floor 109 of the metering chamber 106 when the balloon is inflated thereby sealing the outlet 130 away from the meter roller 110 so that the agricultural product cannot be metered through the outlet 130 even though the meter roller 110 continues to rotate. Deflating the balloon 105 disengages the knob 104 from the lip 112 to once again permit the agricultural product to flow over the lip 112 through the outlet 130 and into the air distribution line 190 . The balloon 105 is made from a sufficiently flexible material, for example an elastomer such as natural or synthetic rubber, to permit inflation and deflation of the balloon. The knob 104 may be made of the same or different material as the balloon 105 . The knob 104 is preferably made of sufficiently flexible material to form a suitable seal with the lip 112 . Both the balloon 105 and the knob 104 are preferably made of sufficient durable material to be able to resist the flow of agricultural product from a constantly rotating meter roller and to withstand repeated inflations and deflations. The balloon 105 may be secured in the metering chamber 106 by attaching base 103 of the balloon to a wall of the metering chamber 106 . When the balloon 105 is inflated as shown in FIG. 1A , agricultural product moved as a result of the meter roller 110 constantly rotating may travel up the side of the balloon 105 . To prevent agricultural product from overtopping the balloon 105 and falling down the other side, a duct may be provided to recycle the agricultural product back to the hopper 150 from the metering chamber 106 . Further, a pressure equalizing duct 155 is provided for venting out air from above the meter roller 110 when the air distribution fan is turned off. Furthermore, to be able to access the inside of the metering chamber 106 to effect maintenance, repair, cleaning or the like of the metering apparatus, a removable gate 170 may be included over an aperture in one of the walls of the metering chamber 106 . Removing the removable gate 170 provides access to the inside of the metering chamber 106 through the aperture in the wall of the metering chamber 106 . With reference to FIG. 2A , FIG. 2B , FIG. 2C , FIG. 2D , FIG. 2E and FIG. 2F , a metering apparatus 200 is shown in which flow of agricultural product 220 from a hopper 250 to an air distribution line (not shown) may be blocked by a meter roller 210 protruding into the hopper 250 and forming a seal with the hopper 250 at an inlet 215 from the hopper 250 into a metering chamber 206 . The metering apparatus 200 comprises the meter roller 210 , in this case a smooth surfaced meter roller although any suitable meter roller (e.g. a pegged roller, fluted roller or high output roller) may be employed, disposed within the metering chamber 206 of a meterbox 207 . The metering chamber 206 is in communication with the hopper 250 via the inlet 215 so that the agricultural product 220 in the hopper 250 can flow into the metering chamber 206 when the meter roller 210 does not block the inlet 215 . The hopper 250 comprises first and second roller plates 251 , 252 having end surfaces 253 , 254 , respectively, that are configured to abut or almost abut the arcuate outer surface 211 of the meter roller 210 . The roller plates 251 , 252 are secured to an inside wall of the hopper 250 and flank the inlet 215 , protruding partially into the inlet aperture 215 . When the meter roller 210 is in a closed position a seen in FIG. 2A and FIG. 2B , the end surfaces 253 , 254 of the roller plates 251 , 252 , respectively, are abutting or in close proximity to the arcuate surface 211 of the meter roller 210 so that there is insufficient space between the arcuate surface 211 and the end surfaces 253 , 254 to permit agricultural product 220 from entering the metering chamber 206 from the hopper 250 . At the same time, the arcuate surface 211 may not actually touch the end surfaces 253 , 254 or may only touch slightly so that the meter roller 210 can continue to rotate or to accommodate surface features on the meter roller, e.g. pegs, in which case a brush may be disposed at the inlet to prevent product from flowing when the meter roller is in the closed position. To open the inlet as shown in FIG. 2D and FIG. 2E , the meter roller 210 may be pivoted downward by rotation of a driven sprocket 265 geared to a gear 217 on a roller shaft 213 on which the meter roller 210 is mounted. Pivoting of the meter roller 210 causes the arcuate surface 211 to move away from the end surface 253 of the first plate 251 thereby opening a gap 219 between the arcuate surface 211 of the meter roller 210 and the end surface 253 of the first plate 251 . The gap 219 permits the agricultural product 220 from the hopper 250 to enter the metering chamber 206 and to be metered down at a regulated rate to outlet 230 at the bottom of the metering chamber 206 by the rotating meter roller 210 , which in this case is rotating clockwise. Further, varying the width of the gap 219 provides an opportunity to change the rate of metered product, permitting changes for various sizes and rates of agricultural product in addition to being able to vary the speed of the meter roller 210 . The outlet 230 is in communication with the air distribution line, which carries the agricultural product 220 to product application outlets for distribution in a field. The sprocket 265 and shaft 213 are configured so that pivoting of the meter roller 210 does not appreciably change the distance between the arcuate surface 211 and the end surface 254 of the second plate 252 . Reversing the pivoting motion of the meter roller 210 causes the gap 219 to close between the arcuate surface 211 and the end surface 253 of the first plate 251 thereby preventing flow of the agricultural product 220 from the hopper 250 to the metering chamber 206 . With reference to FIG. 3A , FIG. 3B , FIG. 3C , FIG. 3D , FIG. 3E and FIG. 3F , a metering apparatus 300 is shown in which flow of agricultural product 320 from a hopper 350 to an air distribution line (not shown) may be blocked by an endless belt 311 of a belt meter 310 that may form a seal with the hopper 350 at an inlet 315 from the hopper 350 into a metering chamber 306 . The metering apparatus 300 comprises the belt meter 310 , in this case a smooth belt although any suitable belt (e.g. a pegged belt or fluted belt) may be employed, disposed within the metering chamber 306 of a meterbox 307 . The metering chamber 306 is in communication with the hopper 350 via the inlet 315 so that the agricultural product 320 in the hopper 350 can flow into the metering chamber 306 when the endless belt 311 of the belt meter 310 does not block the inlet 315 . The hopper 350 comprises first and second belt plates 351 , 352 having end surfaces 353 , 354 , respectively, that are configured to abut or almost abut the outer surface of the endless belt 311 of the belt meter 310 . The belt plates 351 , 352 are secured to an inside wall of the hopper 350 in the inlet 315 leaving a sufficiently sized aperture for the agricultural product 320 to flow through the inlet 315 . When the belt meter 310 is in a closed position a seen in FIG. 3A and FIG. 3B , the end surfaces 353 , 354 of the belt plates 251 , 252 , respectively, are abutting or in close proximity to the outer surface of the endless belt 311 of the belt meter 310 so that there is insufficient space between the outer surface of the endless belt 311 and the end surfaces 353 , 354 to permit agricultural product 320 from entering the metering chamber 306 from the hopper 350 . At the same time, the outer surface of the endless belt 311 may not actually touch the end surfaces 353 , 354 or may only touch slightly so that the endless belt 311 can continue to rotate or to accommodate surface features on the endless belt, e.g. pegs, in which case a brush may be disposed at the inlet to prevent product from flowing when the belt meter is in the closed position. The belt meter 310 comprises the endless belt 311 looped around driven pulley 323 and idler pulley 324 . The driven pulley 323 is mounted on drive shaft 313 and the idler pulley 324 is mounted on idler shaft 314 . The inside surface of the endless belt 311 and the outside surface of the pulleys 323 , 324 may comprise mated engagement elements 326 , 327 that engage each other to assist with preventing slippage of the endless belt 311 when the endless belt 311 is being driven. Slippage would be problematic for the regulated metering of agricultural product 320 by the belt meter 310 . In alternate embodiments, the shaft 314 may be driven and the shaft 313 may be an idler or both shafts may be driven. To open the inlet as shown in FIG. 3D and FIG. 3E , the belt meter 310 may be pivoted downward about driven shaft 313 . Pivoting of the belt meter 310 in this way causes the outside surface of the endless belt 311 to move away from the end surface 353 of the first plate 351 thereby opening a gap 319 between the outside surface of the endless belt 311 and the end surface 353 of the first plate 351 . In addition, the belt meter 310 becomes downwardly inclined toward the side of the inlet 315 at which the gap 319 has opened. The gap 319 permits the agricultural product 320 from the hopper 350 to flow through the inlet 315 on to the endless belt 311 , which in this case is rotating clockwise, to be metered at a regulated rate by the belt meter 310 through the metering chamber 306 down to outlet 330 at the bottom of the metering chamber 306 . Further, varying the size of the gap 319 provides an opportunity to change the rate of metered product, permitting changes for various sizes and rates in addition to being able to vary the speed of the belt meter 310 . The outlet 330 is in communication with the air distribution line, which carries the agricultural product 320 to product application outlets for distribution in a field. Reversing the pivoting motion of the belt meter 310 causes the gap to close between the outer surface of the endless belt 311 and the end surface 353 of the first plate 351 thereby preventing flow of the agricultural product 320 from the hopper 350 to the metering chamber 306 . With reference to FIG. 4A , FIG. 4B , FIG. 4C , FIG. 4D , FIG. 4E and FIG. 4F , a metering apparatus 400 is shown in which flow of agricultural product 420 from a hopper 450 to an air distribution line (not shown) may be stopped from entering the air distribution line by lowering the agricultural product 420 in a metering chamber 406 away from a continuously turning meter roller 410 to disengage the agricultural product 420 from the meter roller 410 . The metering apparatus 400 comprises the meter roller 410 , in this case a pegged meter roller although any suitable meter roller (e.g. a smooth roller, fluted roller or high output roller) may be employed, mounted on shaft 417 and disposed within the metering chamber 406 of a meterbox 407 . The metering chamber 406 is in communication with the hopper 450 via the inlet 415 so that the agricultural product 420 in the hopper 450 can flow into the metering chamber 406 . The agricultural product 420 collects on a floor 409 of the metering chamber 406 and engages with the meter roller 410 . As seen in FIG. 4D and FIG. 4E , when the floor 409 of the metering chamber 406 is in a raised position, rotation of the meter roller 410 , in this case clockwise rotation, meters the agricultural product 420 at a regulated rate up and over a lip 412 proximate an end of an inclined portion 413 of the meterbox 407 to exit the metering chamber 406 through an outlet 430 into the air distribution line, which carries the agricultural product 420 to product application outlets for distribution in a field. When it becomes desirable to cut off flow of the agricultural product 420 to the air distribution line, the floor 409 of the metering chamber 406 is lowered proximate the lip 412 as seen in FIG. 4A and FIG. 4B . The metering chamber 406 comprises a trough portion 401 , the trough portion 401 comprising side walls, the floor 409 and a back wall 402 hingedly secured to the hopper 450 (or an immovable part of the meterbox 407 ) by a hinge 427 proximate the inlet 415 . Allowing the trough portion 401 to swing counter-clockwise around the hinge 427 (in the configuration depicted in FIG. 4D and FIG. 4E ) causes the floor 409 to become lower proximate the lip 412 as seen in FIG. 4A and FIG. 4B . Because the floor 409 proximate the lip 412 is now lower, the meter roller 410 cannot engage the agricultural product 420 resting on the floor 409 thereby stopping flow of agricultural product 420 over the lip 412 and stopping flow of agricultural product 420 into the outlet 430 . To prevent agricultural product 420 from slipping between the inclined portion 413 of the meterbox 407 and the floor 409 when the floor 409 is in the lowered position, the floor 409 comprises a matching inclined portion 403 that slides along the inclined portion 413 maintaining a seal between the metering chamber 406 and the exterior of the meterbox. Further, to ensure that the metering chamber 406 doesn't simply fill up with agricultural product 420 to the level of the meter roller 410 when the floor 409 is in the lowered position, an inlet guard plate 418 depending down from the hopper 450 into the metering chamber 406 is configured to be long enough that the end of the inlet guard plate 418 is at the level of or lower than the lip 412 . To bring the agricultural product 420 back into contact with the meter roller 410 , the trough portion 401 is swung in the reverse direction to raise the floor 409 back to the height depicted in FIG. 4D and FIG. 4E . The trough portion 401 may be raised and lowered by an actuator, for example a linear actuator or a hydraulic cylinder, connecting the trough portion 401 to the hopper 450 . As shown in FIG. 4D , FIG. 4E and FIG. 4F , the actuator may be secured to the outside of the hopper 450 at attachment 455 and to the outside of the back wall 402 of the trough portion 401 at attachment 405 . With reference to FIG. 5A , FIG. 5B , FIG. 5C , FIG. 5D , FIG. 5E and FIG. 5F , a metering apparatus 500 is shown in which flow of agricultural product 520 from a hopper 550 to an air distribution line (not shown) may be stopped from entering the air distribution line by raising a meter roller 510 away from the agricultural product 520 in a metering chamber 506 to disengage the agricultural product 520 from the meter roller 510 . The metering apparatus 500 comprises the meter roller 510 , in this case a pegged meter roller although any suitable meter roller (e.g. a smooth roller, fluted roller or high output roller) may be employed, mounted on shaft 517 and disposed within the metering chamber 506 of a meterbox 507 . The metering chamber 506 is in communication with the hopper 550 via the inlet 515 so that the agricultural product 520 in the hopper 550 can flow into the metering chamber 506 . The agricultural product 520 collects on a floor 509 of the metering chamber 506 and engages with the meter roller 510 . As seen in FIG. 5E , when the meter roller 510 is in a lowered position, rotation of the meter roller 510 , in this case clockwise rotation, meters the agricultural product 520 at a regulated rate up and over a lip 512 proximate an end of an inclined portion 513 of the floor 509 of the meterbox 507 to exit the metering chamber 506 through an outlet 530 into the air distribution line, which carries the agricultural product 520 to product application outlets for distribution in a field. When it becomes desirable to cut off flow of the agricultural product 520 to the air distribution line, the meter roller 510 is raised as seen in FIG. 5A and FIG. 5B . The meter roller 510 may be raised by lifting the shaft 517 . Because the meter roller 510 is now higher, the meter roller 510 cannot engage the agricultural product 520 resting on the floor 509 thereby stopping flow of agricultural product 520 over the lip 512 and stopping flow of agricultural product 520 into the outlet 530 . Further, to ensure that the metering chamber 506 doesn't simply fill up with agricultural product 520 to the level of the meter roller 510 when the meter roller 510 is in the raised position, an inlet guard plate 518 depending down from the hopper 550 into the metering chamber 506 is configured to be long enough that the end of the inlet guard plate 518 is at the level of or lower than the lip 512 . To bring the agricultural product 520 back into contact with the meter roller 510 , the meter roller 510 is lowered back into contact with the agricultural product 520 as depicted in FIG. 5E . With reference to FIG. 6A and FIG. 6B , two side-by-side metering apparatuses 600 a , 600 b are depicted each operating similarly to the metering apparatus depicted in FIG. 5A to FIG. 5F . Both metering apparatuses 600 a , 600 b are housed in the same meterbox 607 . The metering apparatus 600 a comprises a roller housing that is shown housing meter roller 610 a in a raised, product disengaging position, while the metering apparatus 600 b comprises a roller housing that is shown housing meter roller 610 b in a lowered product engaging position. The housing that houses meter roller 610 a is raised and lowered by actuator 674 a , while the housing that houses meter roller 610 b is raised and lowered by actuator 674 b . The actuators 674 a and 674 b may be independently controlled so that one or the other or both meter rollers 610 a , 610 b may be metering or not metering agricultural product. The meter rollers 610 a , 610 b are constantly driven by the same drive axle 627 , whether in the raised or lowered positions. The meter rollers 610 a , 610 b are mounted on separate shafts (not shown) together with separate gears. Gear 615 a for meter roller 610 a can be seen in FIG. 6A . The gears are intermeshed with sprockets 628 a , 628 b mounted on and driven by the drive axle 627 . The drive axle 627 drives the sprockets 628 a , 628 b , which in turn drive the gears and thus the meter rollers 610 a , 610 b . The drive axle 627 also provides an axis for the meter rollers 610 a , 610 b to pivot about when being raised and lowered by the actuators 674 a and 674 b . Raising and lowering the meter rollers 610 a , 610 b does not disengage the gears from the sprockets so the meter rollers 610 a , 610 b are always driven, whether or not they are actively metering agricultural product. Because the meter rollers 610 a , 610 b are mounted on separate shafts, servicing the meter rollers 610 a , 610 b , for example, cleaning or changing out the meter rollers, is facilitated as the meter rollers 610 a , 610 b may be accessed, and if needed individually removed, through access ports 621 a , 621 b . The structure and operation of the remainder of the metering apparatuses 600 a , 600 b are like that described in connection with FIG. 5A to FIG. 5F . The metering apparatuses 600 a , 600 b are shown in cooperation with air distribution lines 640 a , 640 b therebelow. The air distribution lines 640 a , 640 b are housed in an air distribution box 645 and each line 640 a , 640 b receives agricultural product metered by the metering apparatus directly thereabove. Agricultural product metered into each line 640 a , 640 b is carried by a flow of air to product application outlets for distribution in a field. With reference to FIG. 7A , FIG. 7B and FIG. 7C , a metering apparatus 700 is shown in which flow of agricultural product from a hopper 750 to an air distribution line 751 may be stopped from entering the air distribution line 751 by moving, in this case lowering, the agricultural product in a metering chamber 706 away from a continuously turning meter roller 710 to disengage the agricultural product from the meter roller 710 . The metering apparatus 700 comprises the meter roller 710 , in this case a pegged meter roller although any suitable meter roller (e.g. a smooth roller, fluted roller or high output roller) may be employed, mounted on shaft 717 and disposed within the metering chamber 706 of a meterbox 707 . The metering chamber 706 is in communication with the hopper 750 via a tube 714 having an inlet 715 so that the agricultural product in the hopper 750 can flow through the tube 714 into the metering chamber 706 . The agricultural product collects on a floor 709 of the metering chamber 706 and engages with the meter roller 710 . As seen in FIG. 7B , when the floor 709 of the metering chamber 706 is in a raised position, rotation of the meter roller 710 , in this case counterclockwise rotation, meters the agricultural product at a regulated rate up and over a lip 712 proximate an end of an inclined portion 713 extending up from the floor 709 to exit the metering chamber 706 through an outlet 730 into the air distribution line 751 , which carries the agricultural product to product application outlets for distribution in a field. When it becomes desirable to cut off flow of the agricultural product to the air distribution line 751 , the floor 709 of the metering chamber 706 is lowered as seen in FIG. 7A and FIG. 7C . The meterbox 707 comprises a trough portion 701 , the trough portion 701 comprising the floor 709 , a back wall 702 and a ceiling portion 703 , the ceiling portion 703 secured to the tube 714 so that agricultural product may flow from the tube 714 into the metering chamber 706 through an aperture in the ceiling portion 703 . To lower the floor 709 , the trough portion 701 and the tube 714 to which the ceiling portion 703 of the trough portion 701 is secured, are linked to an actuator 727 (e.g. a hydraulic cylinder or an electric actuator) through a flange 728 secured to the back wall 702 of the trough portion 701 . The flange 728 is linked to a plunger 729 by a linkage pin 730 , and the plunger 729 is connected to an extendible rod 726 of the actuator 727 . Extension of the rod 726 pushes the trough portion 701 and the tube 714 vertically downward to the lowered product disengaging position as seen in FIG. 7A and FIG. 7C , while retraction of the rod 726 pulls the trough portion 701 and the tube 714 vertically upward to the raised product engaging position as seen in FIG. 7B . A compression spring 731 seated around the plunger 729 is compressed when the rod 726 is extended thereby exerting a bias on the trough portion 701 and the tube 714 back toward the raised position. In case of a failure of the actuator 727 , the spring 731 ensures that the trough portion 701 and the tube 714 are in the raised position so that metering of agricultural product into the air distribution line 751 may continue. While the tube 714 is depicted as cylindrical, any suitable cross-sectional shape of tube may be employed, for example an elliptical or a polyhedral cross-section (e.g. triangular, square, rectangular, pentagonal, hexagonal and the like). A polyhedral cross-section provides a benefit of reducing a tendency of the tube to twist or move laterally while being raised and lowered. To further reduce the tendency of the tube 714 to move laterally while being raised and lowered, the tube 714 is bracketed by guides 734 and 735 , the tube 714 being allowed to move vertically freely within the guides 734 and 735 . The novel features of the present invention will become apparent to those of skill in the art upon examination of the detailed description of the invention. It should be understood, however, that the scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the specification as a whole.

1a

TECHNICAL FIELD This invention relates to cranial bolts or screws and systems for monitoring physiological functions in human and animal brains. BACKGROUND Cranial bolts are frequently used for temporarily securing a catheter to the skull, the catheter being used for monitoring intercranial pressure in the intensive care of patients who have suffered head injuries. In one procedure a catheter is introduced into the brain through a hollow bolt and the intercranial pressure measured by means of a sensor in the tip of the catheter. The catheter may be inserted into various parts of the brain. Where it is introduced into a cranial ventricle, the catheter may also be used to draw off cerebral spinal fluid (CSF) in order to alleviate pressure increases or to analyse samples of the CSF. Existing cranial bolts are bulky and typically incorporate a Luer lock or other device for fixing the catheter securely to the bolt. More recently interest has arisen in measuring a number of physiological parameters in the brain during intensive care. If a number of securing devices, such as Luer locks are incorporated in the bolt, it becomes even more bulky and awkward to use. SUMMARY It is now proposed to provide a cranial bolt in which one or more tubes (or a single multi-lumen catheter) are fixed directly into a hollow shank forming the body of the bolt and individual passageways are provided within the shank for passing probe(s) or tube(s) into desired positions in the brain. According to one aspect of the invention there is provided a cranial bolt for connecting one or more elongate, flexible members, such as tubes, cables, filaments or the like, with the interior of the skull, said bolt comprising a hollow shank having one threaded end and a second end opposite said threaded end for receiving one or more elongate members, each said member being retained in said second end and communicating with a separate passageway in the shank extending to the threaded end. Conveniently the tube or tubes or other elongate member are fixed into the end of the shank with adhesive. It will be appreciated that instead of fixing a plurality of individual catheters into the second open end of the shank, a multi-lumen catheter could be fixed into the end of the shank and probes or smaller tubes fed through respective lumens and passageways into the brain. The term ‘multi-lumen catheter’ is used here in a broad sense and may comprise a bundle of individual tubes which are gathered together, e.g. by enclosing them in a common external sheath, or held together by a non-tubular gathering device such as a series of external rings or a spring-like coil. Alternatively, the multi-lumen catheter may be a catheter in which two or more lumens are extruded integrally so that externally the catheter appears to be a single tube. Whatever the particular construction selected, the individual lumens are split out of the assembly at the point where the catheter enters the shank and individual connections are made to passageways therein. Similarly, at the end of the assembly remote from the shank, the lumens are split out of the assembly and individual connections made to appropriate devices, e.g. via Luer locks. Although the shank may be manufactured from plastics material, e.g. an engineering plastic such as polycarbonate, the shank is preferably made from metal. Some plastics are hard enough to cut a thread in the skull but metals do this more efficiently. Titanium or its alloys are preferred because they are non-magnetic and interfere less than other materials in magnetic scanning procedures. The bolts of the present invention are designed to make use of the minimum of metal. In order to facilitate manipulation of the bolt and manually screwing the bolt into the skull while minimising the amount of metal employed in manufacturing the bolt, a metal shank is preferably received within a plastics body member which may be moulded with wings or other projections to permit the member to be gripped and the shank screwed more easily into a hole in the skull. Preferably the shank is generally cylindrical and preferably formed with a central axial passageway and a further passageway or passageways disposed around the central passageway. The central passage preferably has a larger cross-section than the further passageways and may be used for example, for draining CSF fluid. The further passageways are preferably angled with respect to the central passageway. For example, they may be inclined at an angle between about 3 and 15° (such as about 5 to 10°) to the longitudinal axis of the shank. In order to avoid the danger of the catheters kinking, particularly at or close to the point where they enter the shank, a kink-resistant catheter construction is preferred. Flexible tubes can be made kink-resistant by stiffening them with a spring 25 , such as a coil spring. The spring may be metal or plastic but preferably is a tubular metal coil spring, and the wire from which it is made preferably has a generally flat cross-section. In order to minimise flow disturbance or contamination of fluids in the tube, the spring is preferably embedded or encapsulated in the wall of the tube or is sandwiched between coaxial tubes which form the catheter. Catheters such as described in U.S. Pat. Nos. 5380304 and 5700253 and in our U.S. patent application Ser. No. 09/093,934 are preferred, and their disclosure is specifically incorporated herein by reference. BRIEF DESCRIPTION OF THE DRAWINGS The invention is illustrated by the following specific description and accompanying drawings of cranial bolts in accordance with the invention, in which: FIG. 1 is a perspective view of cranial bolt showing a member of catheters fixed to its receiving end, FIG. 2A is a perspective view of the same bolt in an exploded view, and FIG. 2B is a perspective, fragmented view of an alternate embodiment of the bolt, and FIG. 2C is a perspective, fragmented view of another alternate embodiment of the FIG. 3 is a schematic, partly in section, showing one way in which the bolt maybe fitted to a patients skull. DETAILED DESCRIPTION Referring to the drawings, the cranial bolt comprises a generally cylindrical shank 1 having a threaded lower end 2 for securing the bolt into a preformed hole in the skull 30 , see FIG. 3 . The distal end 3 of the shank has a smaller diameter than the threaded portion 2 . This is to prevent the passageways within the shank being occluded by uncut portions of the skull at the inner end of the hole which has been cut to receive the threaded end. This arrangement may also avoid the need to ream the hole in the skull after cutting a hole of appropriate size to receive the shank and therefore simplify installation of the bolt. The shank 1 is formed at its upper end with a shaped profile 4 adopted to engage in a hole 5 in a plastic body member 6 . Body member 6 is formed with wing-like projections 7 to facilitate screwing the threaded part 2 of the shank into a preformed hole in the skull. Body member 6 may be moulded separately from the shank or moulded onto the upper part 4 . At its upper end, the body member 6 is formed with a part 8 which is connectible with a flexible collar 9 . Collar 9 may be manufactured from a flexible, resilient plastics material and is a push fit onto the end part 8 of the shank or moulded in situ onto the end of the shank. The collar 9 helps to prevent chafing of the tubes 21 , 22 . Shank 1 is formed internally with a plurality of passageways. As seen best in FIG. 2A, one of the passageways 10 is larger than the other two 11 . Passageway 10 preferably extends axially of the shank and is sized to house a drainage catheter. The passageways 11 may be disposed around the major passageways 10 and are designed to accommodate small catheters or probes for sensing parameters, such as oxygen concentration, carbon dioxide concentration, pH and temperature. FIG. 1 illustrates one way in which tubes 20 , 21 , 22 are grasped together and anchored to the bolt fixed into the extension piece 9 , by fixing with adhesive into the shank portion. The distal ends of the tubes 20 , 21 , 22 may be sealed into the passageways 10 , 11 . The tubes 20 , 21 , 22 may constitute tubular guides through which sensors or smaller catheters are fed to the desired site. This is illustrated in FIG. 1 in which a catheter 23 is fed through tube 22 , passes through the respective passageway in the shank and exits through the distal end of the shank. A Luer lock 24 is provided to maintain the catheter in the desired position after it has been located in the brain. A further alternative method of feeding probes or catheters into the bolt is to provide a multi-lumen tube which is fixed into the shank. Individual lumens are divided from the multi-lumen tube and aligned with passageways in the shank. Probes or catheters having diameters smaller than a lumen can then be fed into a respective lumen and passageway and into the brain through the distal end of the bolt. The tubes, 20 , 21 and 22 are preferably kink-resistant, at least over the portion from the shank 1 to the Luer lock or locks 24 . Because the tubes or catheters are grouped together in the flexible collar 9 and extend axially of the shank, the bolt has a minimum lateral spread. This is advantageous because a bolt which is bulky and has in-feed catheters extending from the bolt in various directions is more likely to be knocked or displaced accidentally during nursing or handling the patient. FIGS. 2B and 2C show alternate arrangements for the location of the passageways through the shank. In practice, it may be desirable to form the outer passageways 11 so that they are inclined at a small acute angle to the longitudinal axis of the shank. Preferably the angle is 3° to 15°, e.g. 4° to 8°. FIG. 3 shows one method of fitting the cranial bolt into the skull 30 . The scalp 31 is cut away for a sufficient distance to gain access to the skull 30 and a hole is cut in the skull 30 of a size which is just less than the diameter of the threaded part 2 . The bolt can then be secured to the hole in the skull 30 , by securing the threaded part 2 into the skull 30 . Once the bolt has been secured into the skull 30 , catheters are passed through the guide tubes 20 , 21 , and 22 into the bolt and through the internal passageways in the bolt into the desired positions in the brain. The guide tubes 21 and 22 may be fixed e.g. by adhesive into the upper part of the bolt. When the bolt is to be removed, the catheters are first withdrawn and the bolt is then removed by unscrewing the shank 1 . The bolt in accordance with the invention can be used to install single or multi-lumen catheters, sensors or drainage or sampling tubes into various parts of the brain, including the ventricles, sub-dural, epidural or parenchymal areas of the brain. Sampling tubes may include microdialysis catheters in which a saline solution is passed down one lumen and samples of chemicals in the brain are extracted through a second lumen via a membrane, and the extracted fluid analysed.

1a

FIELD OF THE INVENTION [0001] This invention relates generally to the fields of medical treatment devices and methods of use. In particular, the invention relates to devices and methods for irradiating tissue surrounding a body cavity, such as a site from which cancerous, pre-cancerous, or other tissue has been removed. BACKGROUND OF THE INVENTION [0002] In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. A biopsy typically results in a biopsy cavity occupying the space formerly occupied by the tissue that was removed. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. Treatment of cancers identified by biopsy may include subsequent removal of tissue surrounding the biopsy site, leaving an enlarged cavity in the patient's body. Cancerous tissue is often treated by application of radiation, by chemotherapy, or by thermal treatment (e.g., local heating, cryogenic therapy, and other treatments to heat, cool, or freeze tissue). [0003] Cancer treatment may be directed to a natural cavity, or to a cavity in a patient's body from which tissue has been removed, typically following removal of cancerous tissue during a biopsy or surgical procedure. For example, U.S. Pat. No. 6,923,754 to Lubock and U.S. patent application Ser. No. 10/849,410 to Lubock, the disclosures of which are all hereby incorporated by reference in their entireties, describe devices for implantation into a cavity resulting from the removal of cancerous tissue which can be used to deliver radiation to surrounding tissue. One form of radiation treatment used to treat cancer near a body cavity remaining following removal of tissue is “brachytherapy” in which a source of radiation is placed near to the site to be treated. [0004] Lubock above describes implantable devices for treating tissue surrounding a cavity left by surgical removal of cancerous or other tissue that includes an inflatable balloon constructed for placement in the cavity. Such devices may be used to apply one or more of radiation therapy, chemotherapy, and thermal therapy to the tissue surrounding the cavity from which the tissue was removed. The delivery lumen of the device may receive a solid or a liquid radiation source. Radiation treatment is applied to tissue adjacent the balloon of the device by placing radioactive material such as radioactive “seeds” in a delivery lumen. Such treatments may be repeated if desired. [0005] For example, a “MammoSite® Radiation Therapy System” (MammoSite® RTS, Proxima Therapeutics, Inc., Alpharetta, Ga. 30005 USA) includes a balloon catheter with a radiation source or configured to receive a radiation source that can be placed within a tumor resection cavity in a breast after a lumpectomy. It can deliver a prescribed dose of radiation from inside the tumor resection cavity to the tissue surrounding the original tumor. The radiation source is typically a solid radiation source; however, a liquid radiation source may also be used with a balloon catheter placed within a body cavity (e.g., Iotrex®, Proxima Therapeutics, Inc.). A radiation source such as a miniature or microminiature x-ray tube catheter may also be used (e.g. U.S. Pat. No. 6,319,188). The x-ray tube catheters are small, flexible and are believed to be maneuverable enough to reach the desired treatment location within a patient's body. The radiation source may be removed following each treatment session, or may remain in place as long as the balloon remains within the body cavity. Inflatable treatment delivery devices and systems, such as the MammoSite® RTS and similar devices and systems (e.g., GliaSite® RTS (Proxima Therapeutics, Inc.)), are useful to treat cancer in tissue adjacent a body cavity. [0006] Tissue cavities resulting from biopsy or other surgical procedures such as lumpectomy typically are not always uniform or regular in their sizes and shapes, so that radiation treatment often result in differences in dosages applied to different regions of surrounding tissue, including “hot spots” and regions of relatively low dosage. However, by conforming the tissue lining the cavity about an inflated member, such as a balloon, a more uniform or controlled radiation can be applied to the tissue. [0007] However, making a robust, inflatable balloon which has a predictable inflated size and shape can be problematic, particularly with a balloon size suitable for breast biopsy/lumpectomy cavities which range from about 0.5 to about 4 inches in maximum diameter, and are typically about 2 inches. SUMMARY OF THE INVENTION [0008] This invention is generally directed to irradiating tissue surrounding a patient's body cavity, and particularly to devices and methods for such treatments. The invention is particularly suitable for treating tissue adjacent a patient's body cavity formed by removal of tissue for a biopsy or lumpectomy. [0009] More specifically, a device embodying features of the invention includes an elongated shaft with a treatment location at a distal portion of the shaft which is configured to receive or which includes a radiation source and an inflatable cavity filling member or balloon surrounding the treatment location on the distal shaft portion having two or more layers of compliant or semi-compliant polymeric materials. In this embodiment, the polymeric material of one or more of the multiple layers of the inflatable balloon in a formed but un-inflated condition has limited expansion to a turgid inflated condition with the balloon material at or near the material's elastic limit. The balloon's volumetric expansion from an initial formed condition to an inflated turgid condition should be less than 200%, preferably less than 175% and should be more than 25%. Typically, the expansion should be about 50% to about 150%. The residual stress in the formed polymeric material of the one or more layers of the balloon should be the result of an expansion of the external surface area of a balloon to the surface area of the balloon in the initial formed condition. This expansion can be represented by the ratio of the external surface area of the initially formed condition of the balloon to the to-be-expanded external surface area of the balloon preform represented as a percentage of the to-be-expanded surface area of the balloon preform. This ratio should be not more than 1000%, preferably less than 800% from a pre-form such as a tube. Preferably, the pre-form is an extruded product. The process of expansion may involve heating the preform and the level of residual stress in the balloon material at the initial formed condition may be dependent on the temperature of the preform during the expansion and the time dependant profile of the heating and cooling cycle of the material during expansion. [0010] The multiple layers of the inflatable cavity filling member should be formed of a thermoplastic elastomeric polymer such as polyester polyurethane, e.g. Pellethane™ which is available from Dow Chemical. Preferably the polymeric material has a Shore Durometer of 90 A. Other suitable polymeric materials may be employed. The polymeric material of the balloon layers may be a blend of polymers or a copolymer. [0011] Balloons of this type are often filled with a radiopaque fluid for visualization for positional and symmetry verification and CT for positional verification and radiation dose planning. The balloons themselves may be radiopaque by compounding radiopaque agents into the balloon material, coating the inside and/or outside surfaces of a balloon layer with radiopaque material or providing a radiopaque material between balloon layers. Radiopaque agents or materials may be one or more metals of the group consisting of tantalum, tungsten, rhenium, titanium and alloys thereof or compounds containing oxides of titanium or barium salts such as those which are often used as pigments. [0012] A radiation catheter device embodying features of the invention preferably has an inflatable cavity filling member or balloon at the treatment location which is configured to at least in part fill the body cavity to be treated. The device also may include an inner lumen configured to be in fluid communication with a proximal vacuum source and one or more vacuum ports preferably proximal and/or distal to the cavity filling member such as described in U.S. Pat. No. 6,923,754 and co-pending application Ser. No. 10/849,410, filed on May 19, 2004, both of which are assigned to the present assignee. Application of a vacuum within the inner lumen aspirates fluid in the cavity through the one or more vacuum ports and the application of a vacuum within the body cavity pulls tissue defining the cavity onto the exterior of the inflated cavity filling member deployed within the cavity so as to conform the tissue lining to the shape of the cavity filling member. [0013] Methods previously described in co-pending applications Ser. No. 11/357,274, filed on Feb. 17, 2006 and Ser. No. 11/593,789, filed on Nov. 6, 2006 for using radiation catheters are suitable for a radiation catheter embodying features of the invention body cavity. The present invention however, provides enhanced control over the expansion of the balloon and a more predictable ultimate balloon size and shape. These and other advantages of the present invention are described in more detail in the following detailed description and the accompanying exemplary drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a perspective view of a catheter device embodying features of the invention including a multilayered balloon. [0015] FIG. 2 is a transverse cross section of the catheter shaft taken along the lines 2 - 2 shown in FIG. 1 . [0016] FIG. 3 is an enlarged transverse cross sectional view of the multilayered balloon wall shown in FIG. 2 . [0017] FIG. 4 is an enlarged sectional view of the balloon wall shown in the circle 3 - 3 in FIG. 3 to illustrate the multiple layers thereof. [0018] FIG. 5 is an enlarged longitudinal cross-section of a radiation tube taken along the lines 5 - 5 shown in FIG. 1 to illustrate the deployment of a radiation source within the treatment location. DETAILED DESCRIPTION OF THE INVENTION [0019] The present invention provides devices and methods for treatment of a patient's body cavity. For example, devices and methods having features of the invention are used to deliver radiation or other treatment into a biopsy site or into a cavity left after removal of cancerous tissue from the patient's body. [0020] FIGS. 1-5 illustrate a catheter device 10 which has an elongated shaft 11 , a cavity filling member or balloon 12 on the distal portion of the shaft which for the most part defines the treatment location, and an adapter 13 on the proximal end of shaft 11 . A plurality of tubes 14 - 18 extend into the adapter 13 and are in fluid communication with lumens 20 - 24 respectively within the shaft 11 which are configured to receive one or more radiation sources 25 . The device 10 also has an inflation tube 26 which is in fluid communication with inflation lumen 27 that extends to and is in fluid communication with the interior of the balloon 12 to facilitate delivery of inflation fluid thereto. The inflation fluid may be radiopaque to facilitate imaging of the balloon and shaft within the patient. The lumen 27 is shown filled with radiopaque fluid in FIG. 1 . The adapter 13 also has a vacuum tube 28 that is in fluid communication with lumens 30 and 31 . Lumen 30 is in fluid communication with proximal vacuum port 32 and lumen 31 is in fluid communication with tubular member 33 which extends across the interior of balloon 12 and which in turn is in fluid communication with distal vacuum port 34 . Radiation delivery tubes 35 - 39 extend through the interior of balloon 12 and are in fluid communication with lumens 20 - 24 within shaft 11 . The radiation delivery tubes 35 , 36 , 38 and 39 extend radially away from a center line axis 40 within the interior of balloon 12 in order to position a radiation source 25 closer to a first tissue portion surrounding a body cavity than a second tissue portion. While tubes 35 , 36 , 38 and 39 are shown as being slightly radially extended within the interior of balloon 12 , less than all of them may radially extend within the balloon 12 depending upon the need for a particular treatment. Moreover, tubes 35 , 36 , 38 and 39 may be in a contracted state within recesses of support member 41 , and one or more of the tubes may be radially extended out of the recesses after the balloon 12 is deployed within a cavity at the target body site. [0021] The support element 41 , which extends between the proximal and distal ends of the balloon 12 , has four compartments 42 - 4 which are designed to receive tubular radiation delivery members 35 , 36 , 38 and 39 respectively. The radiation delivery tubes will not usually be radially extended to the extent that they contact the interior surface of the balloon 12 in an inflated condition. [0022] The balloon 12 is provided with two separate layers 50 and 51 as shown in FIG. 3 . The expansion of the balloon 12 is illustrated in FIG. 2 with the balloon in an as formed, non-turgid condition shown in phantom. The arrow 52 illustrates the expansion of the balloon from the formed condition to the turgid condition. The volumetric expansion is less than 200% of the initial formed volume (diameter shown as arrow 53 ), preferably less than 175% and is typically about 75 to about 125% of the initial balloon volume. While the inflated, turgid balloon 12 is shown as being spherical in shape, other shapes may be suitable, such as an ovoid shape. Depending upon the material and the conditions at the body site, the wall of the turgid balloon may relax somewhat after reaching the turgid condition. The thicknesses of the balloon wall layers can vary depending upon the material characteristics and the number of layers. Typically, the thickness of individual balloon wall layers range from about 0.0003 to about 0.006 inch, preferably about 0.001 to about 0.002 inch. The total thickness of the balloon wall is about 0.0006 to about 0.012 inch, preferably about 0.002 to about 0.004 inch. [0023] The radiation delivery tubes 14 - 18 , which extend into the adapter 13 , may extend through the lumens 20 - 24 in shaft 11 and may form tubes 35 - 39 which are received by the support member 40 and extend into the interior of balloon 12 . [0024] All of the radiation delivery tubes which extend through the interior of the balloon 12 would not necessarily be used in a particular irradiation procedure, but they would be available for use by the physician if needed, e.g. when the balloon 12 of the radiation catheter 10 is not in a desired position and rotation of the catheter is not appropriate or desirable. The shaft 11 is shown as a solid shaft having a plurality of passageways. However, the shaft 11 may be made more flexible by utilizing a plurality of elongated tubes 14 - 18 which are bundled together to form the shaft. Multiple bands may encircle the tubular members along their length to hold the tubular members together. [0025] The radiation source 25 for the brachytherapy device 10 is shown as a radiation seed on the distal end of rod 41 . However, the radiation source 25 may be a solid or liquid radiation source. Suitable liquid radiation sources include, for example, a liquid containing a radioactive iodine isotope (e.g., I 125 or I 131 ), a slurry of a solid isotope, for example, 198 Au or 169 Yb, or a gel containing a radioactive isotope. Liquid radiation sources are commercially available (e.g., Iotrex®, Proxima Therapeutics, Inc., Alpharetta, Ga.). The radiation source 25 preferably includes brachytherapy seeds or other solid radiation sources used in radiation therapy. A catheter with a micro-miniature x-ray source may also be utilized. The radiation source 25 may be either preloaded into the device 10 at the time of manufacture or may be loaded into the device 10 before or after placement into a body cavity or other site of a patient. Solid radionuclides suitable for use with a device 10 embodying features of the present invention are currently generally available as brachytherapy radiation sources (e.g., I-Plant.™ Med-Tec, Orange City, Iowa.). Radiation may also be delivered by a micro-miniature x-ray device such as described in U.S. Pat. No. 6,319,188. The x-ray tubes are small, flexible and are believed to be maneuverable enough to reach the desired location within a patient's body. [0026] The radiation source 18 of the device 10 can include a radiation source which is solid or liquid or both, e.g. a slurry. Suitable liquid radiation sources include, for example, a liquid containing a radioactive iodine isotope (e.g., I 125 or I 131 ), a slurry of a solid isotope, for example, 198 AU or 169 Yb, or a gel containing a radioactive isotope. Liquid radiation sources are commercially available (e.g., Iotrex®, Proxima Therapeutics, Inc., Alpharetta, Ga.). The radiation source 18 preferably is one or more brachytherapy seeds, for example, a radioactive microsphere available from 3M Company of St. Paul, Minn. Other suitable brachytherapy radiation sources include I-Plant™, (Med-Tec, Orange City, Iowa.). Radiation may also be delivered by a microminiature x-ray tube catheter such as described in U.S. Pat. No. 6,319,188. X-ray tube catheters are small, flexible and are believed to be maneuverable enough to reach the desired location within a patient's body. [0027] The device 10 can be provided, at least in part, with a lubricious coating, such as a hydrophilic material. The lubricious coating preferably is applied to the elongate shaft 11 or to the balloon 12 or both, to reduce sticking and friction during insertion and withdrawal of the device 10 . Hydrophilic coatings such as those provided by AST, Surmodics, TUA Systems, Hydromer, or STS Biopolymers are suitable. The surfaces of the device 10 may also include an antimicrobial coating that covers all or a portion of the device 10 to minimize the risk of introducing of an infection during extended treatments. The antimicrobial coating preferably is comprised of silver ions impregnated into a hydrophilic carrier. Alternatively the silver ions are implanted onto the surface of the device 10 by ion beam deposition. The antimicrobial coating may also be an antiseptic or disinfectant such as chlorhexadiene, benzyl chloride or other suitable biocompatible antimicrobial materials impregnated into hydrophilic coatings. Antimicrobial coatings such as those provided by Spire, AST, Algon, Surfacine, Ion Fusion, or Bacterin International would be suitable. Alternatively a cuff member covered with the antimicrobial coating may be provided on the elongated shaft of the delivery device 10 at the point where the device 10 enters the patient's skin. [0028] The balloon 11 may also be provided with radiopaque material to facilitate detection during CT, X-ray or fluoroscopic imaging. Such imaging allows the physician or other staff to detect the size and shape of the balloon and whether the balloon is properly located at the desired location. Preferably, the exterior surface of an inner layer of the balloon is coated at least in part with radiopaque material. One suitable method for coating the surface of the layer is to mix a polymer, preferably essentially the same polymer of the layer, with a solvent such as tetrahydrofuran and a radiopaque agent such as a powdered metallic material, e.g. titanium, gold, platinum and the like, or other suitable radiopaque materials. The mixture is applied to the exterior surface of an inner balloon layer and the solvent is allowed to evaporate, leaving the radiopaque material and the polymer bonded to the balloon layer. The multiple layers of the balloon are then secured to the catheter shaft. [0029] The device 10 may be used to treat a body cavity of a patient, e.g. a biopsy or lumpectomy site within a patient's breast, in the manner described in the previously referred to co-pending applications. Usually the adapter 13 on the proximal end of the catheter device extends out of the patient during the procedure when the balloon is inflated. The catheter shaft 11 is preferably flexible enough along a length thereof, so that once the balloon is inflated to its turgid condition, the catheter shaft can be folded or coiled and placed under the patient's skin before the exterior opening of the treatment passageway to the treatment site is closed. At the end of the treatment time, e.g. 5-10 days, the exterior opening can be reopened and the catheter removed from the patient. See for example the discussion thereof in previously discussed co-pending application Ser. No. 11/357,274. [0030] Radiation balloon catheters for breast implantation generally are about 6 to about 12 inches (15.2-30.5 cm) in length, typically about 10.6 inch (27 cm). The shaft diameter is about 0.1 to about 0.5 inch (2.5-12.7 mm), preferably about 0.2 to about 0.4 inch (5.1-10.2 mm), typically 0.32 inch (8 mm). The individual radiation lumens are about 0.02 to about 0.15 inch (0.5-3.8 mm), preferably about 0.04 to about 0.1 inch (1-1.5 mm). The balloons are designed for inflated configurations about 0.5 to about 4 inches (1.3-10.2 cm), typically about 1 to about 3 inches (2.5-7.5 cm) in transverse dimensions, e.g. diameters. [0031] While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. To the extent not previously described, the various elements of the catheter device may be made from conventional materials used in similar devices. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention be defined by the scope of the appended claims as broadly as the prior art will permit. [0032] Terms such as “element”, “member”, “component”, “device”, “means”, “manufacture”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the terms “means for” or “step for” followed by a particular function without reference to a specific structure or action. All patents and all patent applications referred to above are hereby incorporated by reference in their entirety.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a U.S. non-provisional application. This application claims the benefit of U.S. application Ser. No. 60/234,912, filed on Sep. 25, 2000 under 35 USC 119(e). FIELD OF THE INVENTION The present invention relates generally to QT intervals, and, more particularly to a system and method of statistical analysis of QT interval as a function of changes in ventricular heart rate. DESCRIPTION OF THE RELATED ART The duration of cardiac ventricular depolarization and repolarization is represented as the QT interval, which extends from the beginning of the QRS complex to the end of the T wave on an electrocardiogram (ECG), see FIG. 1 . QT interval prolongation has been associated with the occurrence of arrhythmias, including torsade de pointes, a polymorphic ventricular tachycardia, which can lead to sudden death. Cardiovascular agents such as sotalol, as well as non-cardiovascular therapeutic agents terfenadine (Seldane®) and cisapride (Propulsid®) have caused QT prolongation and sudden death in humans. This has resulted in a more aggressive review by regulatory agencies of data supporting new drug applications. Therefore, a rigorous assessment of pre-clinical and clinical studies evaluating QT interval is advocated for both cardiac and non-cardiac therapeutic agents in development. Changes in heart rate play a major, though not exclusive, role in QT interval variation. Other sources of variation in QT interval include measurement technique, sympathetic and parasympathetic activity, electrolyte disorders (K + , Ca 2+ , Mg 2+ ), changes in cardiac afterload, diseases states, and drug modulators of channel activity within the myocardium. The QT interval, though, typically increases with decreasing heart rate (“HR”), reflected by an increase in the interval between heartbeats, or RR interval of the electrocardiogram, as shown in FIG. 1 . Considerable debate has centered on how to compensate QT for changes in heart rate to provide a corrected QT interval (QTc). The most common approaches use Bazeft or Fridericia's correction, which divide QT by the square root or cube root of the preceding RR interval, respectively. This calculation normalizes the QT interval to a heart rate of 60 beats/min (RR interval of 1 second) and provides the analyst with a single metric from which to assess changes in the QT trend. Both methods have their limitations when trying to compare subjects that have different heart rates. These one-parameter models under-correct QT at high heart rates and over-correct QT at heart rates below 60 beats/min. Undercorrection can lead to a false positive indication of problems while overcorrection may mask the potential hazards of high QT intervals. There is a growing consensus among experts that QT should not be corrected for heart rate. Instead, one should report and compare the QT interval at equivalent heart rates (for example, QT 50 , QT 60 , QT 100 for heart rates of 50, 60, and 100 beats/min, respectively). This approach for interpreting variation in QT is not dependent solely on heart rate but the chosen heart rates are ad hoc. For a wide range of human subjects, the RR intervals for individual cardiac cycles vary enough to establish a functional relationship between QT and RR. Pre-clinically, in vivo animal models such as the dog have been used to measure QT versus RR interval relationships. A multi-parameter regression analysis can be used to relate QT as a function of the previous RR interval for a single subject or a group of subjects. While curve-fitting can characterize the average trend of the QT-RR relationship, heart rate corrections for QT do not account for an increase in QT variance as a function of RR. Increased variability in the QT intervals result in episodes of prolonged QT that are significantly higher than normal. Depending on the nature of these prolonged episodes, they may not be detected by any change in the curve that is determined by the majority of the other non-prolonged points. SUMMARY OF THE INVENTION The present invention satisfies the need to analyze the RR-compensated QT trend as well as any significant increase in QT variance. The present inventors have found that three statistical comparisons are required to fully characterize the QT response to pharmacological intervention: (1) a comparison of post compound dose and pre compound dose curves to give an overall effect; (2) the incidence of points exceeding, for example, an upper 95% confidence bound of the pre-dose curve to reflect the degree of heterogeneity of ventricular repolarization; and (3) the magnitude of these points to provide a quantitative assessment of compound induced changes in the QT-RR relationship. The statistical analysis method of the present invention does not interpret variations of QT as exclusively dependent on changes in heart rate (RR interval), but rather uses the relationship to reference a control baseline response. Furthermore, this method does not exclude its utility for examining changes in QT due to disease states, electrolyte disorders, or changes in sympathetic or parasympathetic activity. Also, this method of analysis can be used to compare any two QT-RR data sets including but not limited to the following: control to treated data, baseline to diseased state, and pre-treated to post-treated timed data. Data discussed below from conscious mongrel dogs under resting conditions, and pharmacological maneuvers using both cardiac and non-cardiac therapeutic agents, support the use of the above-mentioned three statistical comparisons to fully characterize QT prolongation. The data discussed below are purely exemplary, as the present invention is not limited to use with dogs. Rather the present invention may be used equally well with humans as well as other mammals. Additional advantages of the invention will be set forth in part in the description that follows, and in part will be learned from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. Further in accordance with the purpose, the present invention includes a computer readable medium that stores instructions executable by one or more processors to perform statistical analysis of QT interval as a function of changes in the RR interval compared to a control reference, including: instructions for comparing a pre-dose curve of QT interval versus RR interval to a post-dose curve of QT interval versus RR interval; instructions for determining the incidence of points of the post-dose curve that exceed an upper confidence limit of the pre-dose curve to determine the degree of heterogeneity of ventricular repolarization; and instructions for comparing the points of the post-dose curve that exceed the upper confidence limit to the pre-dose curve to determine the magnitude of these points and provide a quantitative assessment of compound induced or other changes in the QT-RR relationship. Still further in accordance with the purpose, the present invention includes a system for statistical analysis of QT interval as a function of changes in the RR interval compared to a control reference, the system including: a memory configured to store instructions; and a processor configured to execute instructions for: comparing a pre-dose curve of QT interval versus RR interval to a post-dose curve of QT interval versus RR interval, determining the incidence of points of the post-dose curve that exceed an upper confidence limit to determine the degree of heterogeneity of ventricular repolarization, and comparing the points of the post-dose curve that exceed the upper confidence limit to the pre-dose curve to determine the magnitude of these points and provide a quantitative assessment of compound induced or other changes in the QT-RR relationship. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one embodiment of the invention and together with the description, serve to explain the principles of the invention. In the drawings: FIG. 1 is a chart showing how the QT interval is measured on an electrocardiogram. FIG. 2 is a chart showing the QT-RR interval relationship following intravenous infusion of a vehicle in the conscious mongrel dog analyzed using the system and method of the present invention; FIG. 3 is a chart showing the QT-RR interval relationship following intravenous infusion of the drug E-4031 in the conscious mongrel dog analyzed using the system and method of the present invention; FIG. 4 is a chart showing the QT-RR interval relationship following intravenous infusion of the compound terfenadine in the conscious mongrel dog analyzed using the system and method of the present invention; FIG. 5 is a chart showing the QT-RR interval relationship following intravenous infusion of the compound cisapride in the conscious mongrel dog analyzed using the system and method of the present invention; FIG. 6 is a schematic diagram showing the system for recording electrocardiogram data of the present invention; FIG. 7 is a schematic diagram showing a computing device used in the system of FIG. 6 ; and FIG. 8 is a flow chart of processing performed by the computing device shown in FIG. 7 . DETAILED DESCRIPTION Reference will now be made in detail to the present preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. I. Recording of Electrocardiogram A system for recording electrocardiogram data in accordance with the present invention is broadly shown in FIG. 6 as reference numeral 100 . An electrocardiogram (ECG) monitor 104 is connected to a patient, such as a dog 102 . Preferably ECG monitor 104 uses electrodes in the Lead II position, however, a QT measurement can be calculated from other ECG vectors, including Leads I and III, a VL, a VR, a VF, and all pre-cordial leads (V1-V6). A vehicle or test compound is administered to dog 102 with a compound administration device 106 . The vehicle or test compound may be administered in various ways, including but not limited to orally, intravenously, or subcutaneous. ECG monitor 104 provides signals 110 to a data acquisition interface 108 which processes the signals 110 and provides processed signals 112 to a computing device 114 . Heart rate (RR interval) and Lead II ECG data are collected continuously on a beat-to-beat basis at a sampling rate of 1000 Hz to allow for millisecond (ms) resolution. Using the sampled data, the QT interval and preceding RR interval are measured on individual cardiac cycles using commercially available data acquisition and analysis software. The software package used in support of the data presented here was from Gould Inc. (Po-Ne-Mah) subsidiary. This software permits visual validation of the determination of end points used in the calculation of the ECG time intervals. The collection of data is not limited to any particular method. For example, ECG time intervals can be measured using a ECG strip chart recorder. Thus, both manual and electrical data collection is possible with the present invention. Computing device 114 , as shown in FIG. 7 , includes a bus 200 interconnecting a processor 202 , a read-only memory (ROM) 204 , a main memory 206 , a storage device 208 , an input device 210 , and an output device 212 . Bus 200 is a network topology or circuit arrangement in which all devices are attached to a line directly and all signals pass through each of the devices. Each device has a unique identity and can recognize those signals intended for it. Processor 202 includes the logic circuitry that responds to and processes the basic instructions that drive device 114 . ROM 204 includes a static memory that stores instructions and data used by processor 202 Computer storage is the holding of data in an electromagnetic form for access by a computer processor. Main memory 206 , which may be a RAM or another type of dynamic memory, makes up the primary storage of device 114 . Secondary storage of device 114 may comprise storage device 208 , such as hard disks, tapes, diskettes, Zip drives, RAID systems, holographic storage, optical storage, CD-ROMs, magnetic tapes, and other external devices and their corresponding drives. Input device 210 may include a keyboard, mouse, pointing device, sound device (e.g. a microphone, etc.), biometric device, or any other device providing input to device 114 . Output device 212 may comprise a display, a printer, a sound device (e.g. a speaker, etc.), or other device providing output for device 114 . As will be described below, a computing device 114 consistent with the present invention may perform a method for statistical analysis of QT interval as a function of changes in the RR interval. Device 114 performs this task in response to processor 202 executing sequences of instructions contained in a computer-readable medium, such as main memory 206 . A computer-readable medium may include one or more memory devices and/or carrier waves. Execution of the sequences of instructions contained in main memory 206 causes processor 202 to perform processes that will be described later. Alternatively, hardwired circuitry may be used in place of or in combination with software and any such arrangement wherein the device is set to perform the tasks of the algorithms disclosed herein, either by hardwire circuitry, stored instructions, or combination thereof, would comprise a means for comparing a pre-dose curve of QT interval versus RR interval to a post-dose curve of QT interval versus RR interval, determining the incidence of points of the post-dose data that exceed an upper 95% single-point prediction limit to determine the degree of heterogeneity of ventricular repolarization and a means for comparing the points of the post data that exceed the upper 95% single-point prediction limit of the pre-dose curve to determine the magnitude of these points and provide a quantitative assessment of treatment-induced changes in the QT-RR relationship instructions to implement processes consistent with the present invention. Thus, the present invention is not limited to any specific combination of hardware circuitry and software. The various treatments with vehicle or compounds are studied in a randomized fashion. The drugs include Methanesulfonamide, N-[4-[[1-[2(6-methyl-2-pyridinyl)ethyl]-4-piperidinyl]carbonyl]phenyl] (i.e., E-4031), terfenadine, and cisapride. E-4031, an antiarrhythmic, terfenadine (Seldane®), an antihistamine, and cisapride (Propulsid®), a gastrointestinal prokinetic agent, clinically have all been shown to cause a clear, dose-dependent increase in QT C . The term “vehicle” as used herein is defined as a non-reactive solvent used in the administration of the compound. II. Analysis of QT Interval as a Function of the Preceding RR Interval The method for statistical analysis of QT interval as a function of changes in the RR interval in accordance with the present invention is performed by computing device 114 . As shown in FIG. 8 , the method 300 of the present invention includes a plurality of steps, including the step 302 of replaying the stored data from ECG. The method further includes: a step 304 of analyzing the QT interval on individual cardiac cycles; a step 306 of statistically analyzing the QT-RR interval relationship; a step 308 of statistically comparing best fit curves of the QT-RR relationship; a step 310 of statistically comparing the number of QT interval measurements exceeding the upper 95% confidence interval; a step 312 of statistically comparing the magnitude of the outliers; and a step 314 of statistically comparing the QT at an RR interval of 1000 ms. Each of the steps of the method 300 of the present invention is explained in the following sections in greater detail. QT Analysis on Individual Cardiac Cycles The calibrated analog signal is replayed on computer device 114 in order to analyze QT interval measurements for individual cardiac cycles. Approximately 250 to 300 consecutive cardiac cycles are analyzed for a pre-dose period and during steady-state compound exposure. This encompasses between three to five minutes of continuous data for each data collection period. A previous analysis for statistical power for the variance of the data for the dog showed that approximately 250 points were required for a probability of 0.15 of a false negative, β, (i.e. determining the treatments to be the same when they are, in fact, different) with a Type I error rate (false positive) of α=0.05. The (α and β values were chosen from historical precedence with physiological data. Sample size determinations should be done for each type of experiment and subject. Each QT measurement is monitored by a technician on a data replay screen (e.g., a computer monitor) connected to computing device 114 . If there is a discrepancy between the software analysis and the technician's interpretation of the end of the T wave, the cardiac cycle is reanalyzed interactively by the technician using on-screen measurement cursors. QT is then analyzed as a function of the previous RR interval for each cardiac cycle of a selected time period. An asymptotic decaying exponential growth curve fit is used to describe the relationship between QT and RR interval: QT=A−B *exp(− C*RR /1000)  (1) The coefficients A, B, and C represent different aspects of the QT-RR relationship. The terms A, B, and C are regression coefficients that are determined by a non-linear regression technique applied to the data. The coefficients A, B, and C are unique for a given data set. The coefficient “A” represents the behavior of QT at very large values of RR. The coefficient “B” represents the behavior of QT at very low values of RR. The coefficient “C” represents the relationship of the intermediate points and the steepness of the curve between low and high RR values. Calculation of the relationship between QT and RR interval is not limited to Equation (1). Rather, other curve fit equations may be used, including a log growth function, Bazett or Fridericia's correction (described above), and all of the equations set forth in T. Matsunaga et al., “QT Corrected For Heart Rate and Relation Between QT and RR Intervals in Beagle Dogs”, Journal of Pharmacological and Toxicological Methods , 38, pp. 201-209 (1998). Another curve fit equation developed by the present inventors is an arc tan function QT=A+B×arctan(C×RR). Statistical Analysis of the QT-RR Interval Relationship All statistical comparisons used the following statistical hypotheses: H 0 (null hypotheses): μ(dose)≦μ(pre-dose) H 1 (alternative hypotheses): μ(dose)>μ(pre-dose) In the interest of QT prolongation, the concern is for QT values elevated above the pre-dose value for the corresponding RR interval defined by the regression analysis-fitted curve. The null hypothesis H 0 is a one-sided hypothesis and all rejections of the null hypothesis are based on whether the dose measurements were greater than 95% of the pre-dose data (i.e. 0.05 significance level). For treatments where the interest lies in detection of increasing QT, the one-sided hypothesis H 0 is the appropriate test. In this case, a QT value that is higher than 95% of the pre-dose data is determined to be different, or prolonged, from the pre-dose data, and the hypothesis H 0 is rejected in favor of the alternative hypothesis H 1 . A false negative is defined as accepting hypothesis H 0 when it should have been rejected. The analysis of the vehicle or compound versus pre-dose effect on QT was accomplished by a statistically significant indication of QT prolongation by at least one of the following: (1) a significant rise in QT post-dose curve above the pre-dose curve; (2) a significant increase in the number of episodes of QT intervals that exceed the pre-dose 95% prediction interval threshold; or (3) a significant increase in the magnitude by which the prolonged points exceed the pre-dose curve. Statistical Comparison of the Curves Equation (1) is used to fit the QT measurements to the preceding RR interval for each separate data set of consecutive cardiac cycles. The data from each sample period for each vehicle or compound dose is fit to the equation using a least squares nonlinear regression method such as, but not limited to, Quasi Gauss-Newton. Post-dose curves are inspected to determine if and at what point the dose curve becomes significantly higher than the pre-dose curve. The upper 95% confidence limit for the difference of the curves is determined for each of the dose-to-pre-dose comparisons. If the dose curve crosses the 95% limit, the QT and RR values and the direction of crossing is noted. If the treatment curve is significantly elevated or depressed for the entire RR range, then the curves will not cross, indicative of an overall significant rise in QT or no significant overall rise, respectively. Statistical Comparison of the Number of QT Measurements Exceeding the Upper 95% Confidence Interval The analysis of the compound versus vehicle effect on QT is also accomplished by comparisons of the number of prolonged points exceeding the 95% confidence interval of their respective pre-dose curves. The pre-dose curve value represents the least squares estimate of QT at that value of RR. The 95% limits are then used to compare the overall effect of the treatment (compound or vehicle) to that of the pre-dose response. The confidence limits of the two curves are combined (pooled) to determine the standard error of the difference between the pre-dose and post-dose curves. The single-point prediction limits for the pre-dose data are used to determine whether a QT point is significantly prolonged. The extent of the confidence and prediction limits depends on the overall variability of the data and the values of the coefficients. The number of pre-dose data that exceed the upper 95% prediction limit (referred to herein as “outliers”) is compared to the number of post-dose data that exceed the limit for each of the time periods. A repeated measures test for significant difference between pre-dose and post-dose outliers is conducted to evaluate an effect. In the case of small but consistent effects, the repeated measures test detects significant differences better than individual tests. Individual significance tests of the proportion of prolonged outliers, such as, but not limited to Chi-square and Fisher's Exact Test, are also conducted to determine if any one treatment is significantly higher than the pre-dose results. To minimize the chance of false negatives, β, conventionally known as “Type II errors,” no multiple comparison adjustments are made for the individual tests. Statistical Comparison of the Magnitude of the Outliers Once the outliers are identified, they are compared to the pre-dose curve to estimate the magnitude of prolongation, ΔQT, above the QT-RR curve fit to the pre-dose data. The magnitude of prolongation is referenced to the curve rather than the upper 95% confidence bound because the curve is the best estimate of the QT-RR functional relationship, regardless of the number of data points. The resulting ΔQT are then compared within treatment groups (dose to pre-dose) using a comparative statistical method such as, but not limited to, signed rank tests and t-test. Statistical Comparison of the QT at RR 1000 ms The nonlinear curve defined by Equation (1) is used to provide a least squares estimate of the QT interval at a physiologically relevant heart rate of 60 beats/min (QT RR1000 ). A one-tailed Student's T-test is then used for comparison of post-dose versus the pre-dose response. Statistical Analysis Across Treatments When comparing two or more treatments given with the same dosing protocol, the responses are first compared to the pre-dose data and curve. Treatments include, but are not limited to, different dose levels, compounds and days. The resulting outlier numbers and magnitudes (ΔQT) are then compared between treatments. For measurements at repeated intervals, a repeated measures test is conducted on the number and magnitude data for statistical significance. Individual tests are conducted without multiple comparison corrections to minimize the chance of false negatives. A simultaneous overall measure of significant treatment effect over all measurement times provides increased statistical power for a consistent trend at all data collection periods. This overall measurement was done using a Mantel-Haenszel statistical analysis. The analysis can be done using conventional independent (such as a Chi-Square) or correlated (such as McNemar) statistical tests and can include a continuity correction for low frequencies or outliers. Individual measurements may also be performed to investigate each period's results. Other statistical tests may be performed using transformed outlier frequency data and standard repeated measures of variance (such as ANOVA, Linear Models) or categorical methods (such as logistic regression and generalized linear models). III. Results of the QT Interval Analysis The results of three tests for significance increases the sensitivity of detecting QT prolongation by testing for the incidence and magnitude of prolonged episodes. Conventional methods such as Bazett or Fridericia may not fit the data, depending on the range of RR intervals associated with each QT interval. Additionally, conventional testing does not account for the effects of increasing incidence in prolonged QT episodes nor do they test specifically for the magnitude of the determined outliers. The statistical method of the present invention evaluates individual responses to ensure sensitivity in detecting statistically significant effects in a heterogenous population that may otherwise mask changes if one evaluates only the pooled study group response. Overall Rise in QT Exemplary data of the QT-RR relationship for a variety of compounds known to prolong QT are shown in FIGS. 2-5 , with the statistical analysis summarized in Table 1. The Bazett correction for the treatment curve is also included in FIGS. 2-5 to demonstrate how poorly this predicts the QT-RR relationship. The data in FIG. 2 show no difference between the vehicle and the pre-dose baseline for this dog. For E-4031, FIG. 3 shows a large rise in overall QT over the entire RR range. The results for terfenadine, shown in FIG. 4 , are slightly different from those of E-4031. The QT values of the terfenadine data are close to the baseline values for low (<600 ms) RR values. However, as with E-4031, there is a clear rise in QT values at RR values above 1000 ms. The effect of cisapride on the QT-RR relationship is shown in FIG. 5 . The post-dose curve is not significantly greater than the pre-dose curve for RR>1094 ms (the crossing point of the curves). The rate dependence of the cisapride effect would not be shown in a simple measurement of QTc. Increase in the Number and Magnitude of Prolonged QT Values Table 1 summarizes the statistical analysis of the number and magnitude of ΔQT measurements exceeding the upper 95% confidence bounds of the curve fit. E-non-breaking E-4031, terfenadine, and cisapride all caused a significant increase in the number and magnitude of the outliers compared to the pre-dose and vehicle response. TABLE 1 Statistical analysis of treatment effect on QT interval in the conscious mongrel dog: Comparison of pre- versus post-dose response as well as drug versus vehicle treatment QT exceeding 95% confidence bounds of pre-does curve Vehicle Treatment outlier Vehicle vs Drug crosses #outliers/ Vehicle Mean mean ΔQT Mean ΔQT pre-dose Treatment Time QT RR1000 total #outliers/total (range) ΔQT range ΔQT vs t = 0 #outliers of outliers curve E-4031 Pre 238 ± 9    10/313 8  7-23 Post 290 ± 12* ξ 198/198 49 41-87 P < 0.001 P < 0.001 P < 0.001 No Pre-dose Pre-dose 6 terfenadine Pre 239 ± 10   43/351 12/374 (6-8) 9  8-17 Post 253 ± 6* ξ 271/297 14  8-23 P < 0.001 P < 0.001 P < 0.001 No Post-dose Post-dose 7 cisapride Pre 237 ± 6   14/315 56/329 (6-11) 6  5-7  Post 240 ± 18 130/324 12  5-47 P < 0.001 P < 0.001 P < 0.001 Yes: RR = 1094 ms QT RR1000 mean ± SEM was derived from the curve fit and 95% Cl. *Denotes significant increase between pre- and post-dose measurements (P < 0.05). ξ Denotes significant increase in .QT for drug response compared to .QT for vehicle treatment. IV. Discussion of the Results Conventional single-parameter models, such as Bazett's or Fridericia's, while able to provide one measure of prolongation, fail to adequately fit the data over the wide RR range. The single parameter model forces QT=0 at R=0. QT then increases monotonically with increasing RR, resulting in overly high QT values at RR>1000 ms. Both of these models will overestimate the QTc at low RR, calling normal values prolonged, and underestimate QTc at high RR, calling almost nothing prolonged. The use of a multiparameter model of the present invention, rather than reporting the functional relationship of QT to RR, uses the pre-dose response over the RR domain as a baseline from which to measure the treatment response for a given experiment. Inherent differences between subject pre-treatment QT-RR relationships should be taken into account in the response of the subject to treatment. Therefore the QT response to treatment is examined within the context of the observed pre-treatment QT statistics. Effects such as change in baseline level or change in QT variability, are then accounted for and valid comparisons between subjects (or treatments) can be done. It will be apparent to those skilled in the art that various modifications and variations can be made in the system and method of the present invention and in construction of this system and method without departing from the scope or spirit of the invention. As an example, repeated measures analysis of the number of outliers can be accomplished using transformed data or sets of 2×2 contingency tables (eg. Mantel-Haenszel). Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the description and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

1a

BACKGROUND OF THE INVENTION This invention relates to an improvement in a spool braking device for a double-bearing fishing reel. The conventional means for adjusting the braking force of the spool in a double-bearing fishing reel, especially in a large double-bearing fishing reel, has the construction in which an adjustment lever rotating around a reel side-plate is provided on the reel side-plate on the attachment end of a rotary handle so as to rough-adjust the braking force while a dial knob for fine-adjustment is fitted to the reel side-plate to make the fine adjustment. Such prior art devices are disclosed in U.S. Pat. Nos. 3,478,979 and 3,425,644, for example. However, the mode of braking the spool varies with the kind of fishing. In other words, some kinds of fishing do not require much adjustment once the braking quantity is set, while others require frequent adjustment of the braking force during fishing. In the latter case, especially, the adjustment operation must be carried out rapidly and reliably. In the conventional system described above, however, the adjustment lever and the fine adjustment dial knob can not be rotated simultaneously and rapidly. In particular, when the spool is set for braking, it is difficult to release it so that it can rotate completely freely in order to pay out the fishing line, or to return a freely-rotating spool after the fishing line has been paid out to the original braking state in a rapid and smooth way. In addition, the adjustment quantity of the fine adjustment dial knob can not be clearly checked by eye when fishing. SUMMARY OF THE INVENTION The present invention is designed to eliminate all these problems with the prior art. The first characterizing feature of the present invention is that a lever for the fine adjustment of the spool braking force is provided on the same spool shaft as that of an operation lever for the coarse adjustment of the braking force so that the adjustment of the braking force is in the same direction, and an adjustment of the spool braking force over a wide range can be made quickly, smoothly and lightly. The second characterizing feature of the present invention is that the operation lever for the coarse adjustment of the spool braking force and the operation lever for the fine adjustment can be rotated to substantially the same angle on the same lever shaft so that both levers can be operated simultaneously. According to this construction, the spool can be operated extremely conveniently by two fingers so as to bring the spool from its braking condition to a freely rotating condition for casting the line, or return it from the free rotation condition to the original braking condition. Another feature of the present invention is that the position in which the fine adjustment of the spool braking force is set can be easily confirmed at once in accordance with the position of the fine adjustment lever, and the lever itself can be set easily. These and other objects and features of the present invention will become more apparent from the following detailed description of one embodiment thereof taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a longitudinal sectional view of the present invention; FIG. 2 is a right-hand side view of the present invention; FIG. 3 is a left-hand side view of the friction transmission member of the present invention; and FIG. 4 is an exploded perspective view of the principal components of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention will now be described with reference to the accompanying drawings. A spool shaft 4 is supported slidably in the axial direction by bearings 3 between right and left reel side-plates 1, 2 and a spool 5 is rotatably supported on the spool shaft 4 by bearings 6. A pinion 7 provided integrally with the reel side-plate 1 end of the spool shaft 4 engages with a driving gear 9 of a handle shaft 8 which is pivoted to the reel side plate 1. A braking member 11, which is prevented from rotating in reverse by anchor pawls 10 pivoted to the reel side-plate 2, is fitted to the reel side-plate 2 end of the spool shaft 4 so as to be movable only in the axial direction, as shown in FIG. 3. The braking member 11 is urged toward and brought into contact with the bearing 3 by a spring 12 that is interposed between the braking member 11 and the bearing 6. A friction transmission member 14 is interposed between the braking member 11 and a flange 13 of the spool 5. The friction transmission member 14 has a construction that is well known in the art, it consists of a metal plate 15 engaging with the braking member 11, a metal plate 18 engaging with an engagement groove 17 of a cylinder 16 that is formed on the flange 13 so as to project therefrom, and washers 19 made of leather, synthetic resin or the like, interposed between these metal plates 15 and 18. This friction transmission member 14 transmits the rotation of the spool shaft 4 to the spool. A leaf spring 20 that is stronger than the spring 12 is interposed between the bearing 6 and the pinion 7 on the reel side-plate 1 side, and the spool shaft 4 beyond the pinion 7 is supported rotatably by the bearing 3. A fine adjustment cam 21 is formed integrally with an inner operation cylinder 24, and a fine-adjustment lever 23 engages with a slit 22 which is formed at the outer end of the cylinder 24. This operation cylinder 24 is fitted to the spool shaft 4 outside the bearing 3. Pins 26 projecting outward in the radial direction and other pins 27 projecting inward in the radial direction are provided on a support case 25 on the bearing 3. The outwardly projecting pins 26 slidably engage with engagement grooves 29 formed on the inner surface of a bearing cylinder 28 which is fitted and fixed to the reel side-plate 1 and comes into contact with a front cam surface 31 of a cam cylinder 30 which is fitted around the outside of the operation cylinder 24. The inwardly projecting pins 27 come into contact with the fine adjustment cam 21 of the operation cylinder 24. An adjustment lever 33 engages with slits 32 formed in the outer end of the cam cylinder 30. A knob 34 fixed to the end of the adjustment lever 33 has a ball 38 that is urged by a spring 37 so that the ball can engage with one of a plurality of stop holes 36 in a semicircular stop plate 35 fixed to the outer surface of the reel side-plate 1. The knob 34 can thus be held at any rotational position. The fine-adjustment lever 23 is shorter than the adjustment lever 33 and its knob 39 has a ball 43 urged by a spring 42 so that the ball resiliently engages with one of a plurality of stop holes 41 of a disc plate 40. This plate 40 is fixed to the reel side-plate 1 and has a diameter smaller than that of the stop plate 35. Thus, both levers 23 and 33 are provided with spring loaded ball detent means (parts 36-38 and 41-43) to enhance their operation. In the drawings, reference numeral 44 represents a handle, 45 in a washer and 46 is a plate cover. In the embodiment of the present invention having the construction described above, when the adjustment lever 33 is rotated clockwise in FIG. 2, the cam cylinder 30 rotates so that its cam surface 31 pushes the pins 26 which push the bearing 3 through the support case 25, the pins 27 and the fine-adjustment cam 21. This pressure pushes the spool shaft 4 and then the spool 5 via the leaf spring 20, thereby increasing the frictional force transmitted by the friction transmission member 14, making it transmit the rotation of the handle shaft 8 by the handle 44 to the spool 5. When the adjustment lever 33 is rotated counter clockwise, on the other hand, the transmitted frictional force is reduced and the spool braking force can be adjusted over a large range. When the fine-adjustment lever 23 is rotated clockwise, the operation cylinder 24 rotates and its fine-adjustment cam 21 pushes the bearing 3 directly so that the frictional force transmitted by the friction transmission member 14 is increased by a limited amount. When the fine-adjustment lever 23 is rotated counter clockwise, on the other hand, the transmitted frictional force is reduced by a limited amount and thus the spool braking force can be adjusted within a fine range. More specifically, when the lever 23 is rotated clockwise in FIG. 2, the operating cylinder 24 rotates integrally therewith because the lever engages with the notched groove 22 in the operating cylinder 24, and the fine adjustment cam 21 of the operating cylinder 24 comes into contact with the pin 27 projecting from the inner surface of the support case 25. However, the support case 25 does not move outwards (towards the handle 44) because the bearing cylinder 28 is attached integrally to the reel side plate 1 by the cam cylinder 30, and the operating cylinder 24 moves the shaft 4 in the inward axial direction via the bearing 3, thereby minutely increasing the frictional transmission force of the frictional transmission member 14. The coarse and fine adjustments are provided by the difference in the cam surfaces 21 and 31, see FIG. 4. The angle of inclination of the fine adjustment cam surface 21 of the operating cylinder 24 is less than that of the cam surface 31 of the cam 30 of the adjustment operation lever 33, and the corresponding amounts of axial movement of the shaft 4 are thus in proportion, i.e., surface 31, the coarse adjustment, moves the shaft 4 more than does surface 21. Accordingly, even if the rotation of the adjustment operation lever 33 is the same as heat of the fine adjustment operation lever 23, the degree of axial motion by the shaft 4 is correspondingly different. Accordingly, after the spool braking force is roughly set by the adjustment lever 33 in accordance with the kind of fishing and the kind of fish the fisherman intends to catch, the spool braking force is then fine-adjusted by the fine-adjustment lever 23 before fishing. To pay out the fishing line, both the adjustment lever 33 and fine-adjustment lever 23 are simultaneously rotated fully counterclockwise. The fishing line is paid out while the spool 5 is thus able to rotate freely. The fishing can be done immediately by rotating both the adjustment lever 33 and fine-adjustment lever 23 back to their original positions after the fishing line is paid out. While the invention has been described in detail above, it is to be understood that this detailed description is by way of example only, and the protection granted is to be limited only within the spirit of the invention and the scope of the following claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is based on provisional application serial number 61188656, filed on Aug. 12, 2008. BACKGROUND OF THE INVENTION [0002] This invention relates generally to the field of cosmetics and more specifically to a composition of matter comprising a semi-permanent mascara that is waterproof, will not run smudge or smear, and lasts 2 to 3 weeks; and the process to professionally apply the same. [0003] Mascara was invented many years ago, and throughout the years, different chemicals and additives have been created in an attempt to make the mascara more waterproof and smudgeproof. Currently this product application does not exist. Traditional mascara runs and smears. Mascara claiming to be waterproof only lasts 24 hours and can be removed with creams and oils. Tinting, coloring or dyeing the eyelashes with tints or dyes only adds pigment, not volume, texture or length. Tinting, coloring or dyeing the eyelashes is also not permitted in all states. Strip lashes are temporarily glued onto the skin and fall off easily and can not endure any water. Eyelash extensions use an adhesive to adhere one synthetic lash to the existing lash. Eyelash extensions are very costly and take 2 hours to apply. [0004] Cyanoacrylate was invented years ago and has many uses in the medical field. Recently, the specific pharmaceutical grade, black pigmented cyanoacrylate has been used to bond individual eyelash extensions to the eyelashes. However, the pigmented cyanoacrylate has not been used as a stand alone mascara coating application. [0005] Cry Baby Permanent Mascara's combination of microfiber powder polytetrafluoroethylene with the black pigmented cyanoacrylate creates a custom blend with a superior bond to the eyelash. When the coating mixture is applied to the eyelash like traditional mascara, it cures in 2 to 5 minutes, creating a 100% waterproof, smudge and smear proof eyelash coating lasting 2 to 3 weeks. [0006] Consumer mascara applications are not completely waterproof, nor are they completely smudge proof. Physical activities such as swimming or excessive exercise will cause the traditional mascara to run or smear. No other product exists that is completely waterproof and smudgeproof or that lasts 2 to 3 weeks. BRIEF SUMMARY OF THE INVENTION [0007] The primary object of the invention is to create a professionally applied semi-permanent mascara that will not run, smear, is 100% waterproof, is antimicrobial, and lasts 2 to 3 weeks. [0008] Another object of the invention is to create a method to professionally apply the semipermanent mascara. [0009] Other objects and advantages of the present invention will become apparent from the following descriptions, taken in connection with the accompanying drawings, wherein, by way of illustration and example, an embodiment of the present invention is disclosed. [0010] In accordance with a preferred embodiment of the invention, there is disclosed a composition of matter comprising semi-permanent mascara encompassing a tinted type of pharmaceutical grade cyanoacrylate, mixed with a small amount of polytetrafluoroethene in microfiber powder form, and professionally applied to the eyelashes creating a semi-permanent mascara application that lasts 2 to 3 weeks. [0011] In accordance with a preferred embodiment of the invention, there is disclosed a process to professionally apply a composition of matter comprising semi-permanent mascara which is a tinted type of pharmaceutical grade cyanoacrylate, mixed with a small amount of polytetrafluoroethene in microfiber powder form, creating a semi-permanent mascara application that lasts 2 to 3 weeks. BRIEF DESCRIPTION OF THE DRAWINGS [0012] The drawings constitute a part of this specification and include exemplary embodiments to the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention. [0013] FIG. 1 is a front view of the eye area with bottom eyelashes covered with gel pad. [0014] FIG. 2 is a front view of the eye area with bottom eyelashes not covered by gel pad. [0015] FIG. 3 is a top view of the applicator tools used in the invention. [0016] FIG. 4 is a top view of tools and process to mix the adhesive to the dry powder microfibers. [0017] FIG. 5 is a top view of mixing the adhesive with the dry powder microfibers. [0018] FIG. 6 is a front view of the process to apply the product to top eyelashes. [0019] FIG. 7 is a front view of the process to apply the product to the bottom eyelashes. [0020] FIG. 8 is a front view of the process of precision application of the product to the top eyelashes. [0021] FIG. 9 is a front view of the process and tools used to remove the product from the eyelashes. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0022] Detailed descriptions of the preferred embodiment are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in virtually any appropriately detailed system, structure or manner. [0023] Cry Baby Permanent Mascara is a composition of matter comprising a material and a procedure in which you curl, and coat the eyelashes with waterproof, black pigmented, pharmaceutical grade adhesive coating (a special type of rubber toughened cyanoacrylate). It is mixed with a dry white microfiber powder which consists of an insoluble, irregular shaped polytetrafluoroethylene (PTFE) fibers CAS #9002-84-0. The procedure is to be performed by a certified salon professional. [0024] Referring to FIGS. 1-8 , the professional first cleans the eye area 10 and places protective medical tape or gel eye pads 14 over the bottom lashes 13 to protect the bottom lash 13 and skin. Next the top lashes 12 are curled with an eyelash wand if necessary. [0025] On a glass slab 19 , the adhesive coating (black pigmented cyanoacrylate) 17 is mixed with the dry powder microfibers (PTFE) 18 to the correct consistency (thin to paste like) and is applied with a stainless-steel pick applicator 16 or mascara wand 15 to each individual eyelash 12 . It is applied by stroking lashes evenly from lash base 12 a to tip 12 b and dried with an electric air blower. You repeat until all eyelashes 12 on the top lid 11 are covered and fully dry. The bottom lashes 13 are then cleaned and separated. Medical tape or gel eye pads 14 are placed under the bottom eyelashes 13 to protect the skin. An electric air blower is held on the eye area 10 for client comfort. The bottom lashes 13 are then coated with the adhesive 17 and fiber 18 mixture and dried. [0026] This is a semi-permanent alternative to enhance the natural lash 12 , 13 and keep the curl, like traditional mascara, yet it is waterproof, smear proof, and it will never run. An application can last 2-3 weeks or more. The coating can be professionally removed, or it will simply wear off in 2-3 weeks on it's own. Referring to FIG. 9 , to remove the coating, the professional holds a non-woven 2×2 pad 20 under or behind the lashes 12 , 13 . Using a micro brush 21 or foam shadow applicator 22 , the professional applies liquid remover by pressing lashes 12 , 13 brushing on the remover to release the coating from the lashes 12 , 13 . Continue until all coating is removed. Rinse lashes 12 , 13 with warm water and cleanse. [0027] Client Analysis— [0028] A client with healthy skin and eye area 10 . [0029] Anyone with sensitive eyes or skin is not a good candidate. [0030] Materials— [0031] Eyelash curler [0032] Micro fibers (PTFE) 18 [0033] Black cyanoacrylate 17 [0034] Adhesive remover liquid/gel [0035] Primer (93% alcohol) [0036] Needle nose tweezers [0037] 3M-medical tape/Gel eye pads 14 [0038] Disposable setup tray [0039] Adhesive applicators/separator [0040] Stainless steel pick 16 [0041] Mascara wand 15 (large, medium and mini) [0042] Micro brushes 21 [0043] Non-woven 2×2 pads 20 [0044] Foam shadow applicators 22 [0045] Remover applicator brush/Ultra brush [0046] Electric air blower [0047] Procedure Application— [0000] 1. Position client on facial bed or chair. 2. Clean eye and lash area. 3. Apply gel pads 14 or medical tapes to protect bottom lashes 13 . 4. Curl top lashes 12 with lash curler (if necessary). 5. Apply primer to the top eyelashes 12 . 6. Custom mix adhesive 17 and micro fibers (PTFE) 18 for individual client needs. 7. Separate top lashes 12 and apply adhesive to one top lash 12 at a time or traditionally with a mascara wand 15 . 8. Stroke adhesive fiber coating from base 12 a to tip 12 b and blow dry for 15 seconds. 9. Do not get adhesive coating on the skin or eyelid 11 . 10. Repeat until all top lashes 12 are covered and completely dry. 11. Remove bottom lash 13 protector 14 . 12. Replace a gel pad 14 or medical tapes under bottom eyelashes 13 to protect skin 13. Clean and prime bottom lashes 13 . 14. An electric air blower is used during bottom lash 13 application. 15. Have client hold electric air blower on the eye area 10 on bottom lashes 13 . 16. Keep air blowing on eye area 10 the entire application of bottom lashes 13 to insure client comfort. 17. Have client look up with eyes open and begin separating and coating bottom lashes 13 . 18. Allow client to blink as necessary. 19. Blow dry lashes 12 , 13 thoroughly. [0048] This procedure is for salon professionals only; they must be licensed and certified. The Cry Baby Permanent Mascara procedure should take 30 minutes. [0049] Currently this product application does not exist. Traditional mascara runs and smears and waterproof versions only last 24 hours and can be removed with creams and oils. Tinting, coloring or dyeing the eyelashes with hair color only adds pigment, not volume, texture or length, and it is not allowed in all US states. Strip lashes are temporarily glued onto the skin and fall off easily and cannot endure any water. Eyelash extensions use an adhesive to adhere one synthetic lash to the eyelash and it is very costly and takes 2 hours to apply. [0050] Cry Baby Permanent Mascara is mascara applied by a salon professional that must be trained and certified. It is the texture of traditional mascara but it adheres to the eyelashes and causes a 100% waterproof coating that colors, thickens, lengthens and strengthens the lashes. It allows flexibility with an opaque gloss finish. Once cured it will last 2-3 weeks or longer. There is not a product or application like it. This product application fills a niche. It has the highest performance as a waterproof eyelash coating. It is cost effective and time saving compared to other eyelash extension applications. It is anti-microbial and can wear off on its own without having to be removed at the salon. Once it starts to wear off, one can just start using regular mascara again, or it can be professionally removed and reapplied every 2 to 3 weeks. [0051] Product development— [0052] The adhesive coating or the powdered PTFE microfibers will be developed in different colors using FDA approved pigments for the eye area (i.e. brown, blue, hot pink and purple). Black and clear are the only colors currently available in the adhesive. The pigment will be unique to this procedure only. [0053] While the invention has been described in connection with a preferred embodiment, it is not intended to limit the scope of the invention to the particular form set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.

1a

The present invention relates to a portable foot bath with a tub having collapsible sides for compact packing and shipping. Portable foot baths are known but they are difficult to operate for some people who have a problem bending down to operate the controls which are usually at floor level. In addition, because of the tub height, it is difficult to package a number of tubs in a single carton, and causing the packing and shipping of foot baths to be relatively costly. Furthermore, the arch of the foot is neglected in massaging while in a foot bath. SUMMARY OF THE INVENTION The invention is a wet/dry foot bath or spa having a tub of rubber or soft plastic, and a motor underneath the floor having a vibratory coil which causes limited reciprocating movement of the floor of the tub. A feature of the present invention is to provide a rope type heater which radiates heat in the entire undersurface of the floor of the tub and is mounted in channels in a heater holder. A further feature of the present invention is to provide metal reflectors above the rope heater which aids in the transmission of heat generated by the rope heater to substantially all areas of the floor of the foot bath tub. Another feature of the present invention is to provide an arch support centrally located in the floor of the tub for massaging the arch of a foot, and spaced around it are rounded projections for massaging the foot in general. Another feature of the present invention is to provide a remote control unit connected by a line cord in the base of the tub so that the user can operate the foot bath without bending down to operate the controls. A further feature of the present invention is to provide bendable sides of the tub of the foot bath which can be folded over to reduce the overall height of the tub for packing and shipping. In order that the present invention will be more fully understood it will now be disclosed in greater detail with reference to the accompanying drawings in which: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan view of a portable foot bath constructed in accordance with the teachings of my invention. FIG. 2 is a sectional view taken along the lines 2--2 of FIG. FIG. 3 is a top plan view of a heater platform showing the rope heater placed in heater channels. FIG. 4 is an exploded view of all the elements of the present invention. FIG. 5 is a top perspective view of the foot bath showing the remote control unit mounted in the base. FIG. 6 is a top perspective view of the base platform, and FIG. 7 is a partial sectional view of the tub showing accordion sides which can be folded down for packing and shipping. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIGS. 1, 2 and 5 a portable foot bath is shown provided with a tub 10 fabricated of rubber or a soft plastic, such as vinyl. The tub is generally of a rectangular shape and is provided with a peripheral top edge 12, as seen in FIGS. 2, 4 and 5. The top edge 12 is folded over the sides 14 of the tubs in order to conserve space in a packing carton. However, when it is desired to use the foot bath the top edge 12 is grasped by the user's hands and pulled up to position shown in dotted lines in FIG. 2 and as well as shown in FIGS. 4 and 5. The floor 16 of the tub 10 has spaced shallow, rounded projections 18 which function as foot massaging elements. The floor of the tub also has a centrally located curved arch support 20 which is designed to massage the arch of the foot. Referring now to FIGS. 2 and 4 a heater platform 24 is shown mounted on the base support 22 and has a sinuous channel 26 on the top surface of the platform. The channel 26 is provided with a rope heater 28 within the entire sinuous channel 26 in order to radiate heat throughout the floor 16 of the tub. The heater 28 is connected to a power source (not shown) and is provided with a thermostat 30. The rope heater 28 is held in place by holders 32, as seen in FIG. 3. A motor bracket 34 is located at the underside of heater platform 28 and is affixed to four bosses 36 projecting downward from the bottom of platform 28 by means of bolts 38. A motor 40 having a vibrating coil 42 is affixed to the bracket 34. Located above the heater platform 24 having the rope heater 28 are a pair of spaced thin metal reflectors 44 such as aluminum foil. The reflectors 44 are connected by a smaller reflector 46 having a central opening 46 which is aligned with opening 25 in the heater platform 24. All of the metal reflectors abut the underside of the floor of the tub 10 and function to radiate the heat generated by the rope heater throughout the floor 16 of the tub 10. The heater platform 24 is fixed to the base platform 22 by means of bosses 48 which are placed in holes 50 in the base platform, and attached by screws 52. Non-marking rubber feet 54 cover the screw heads. The tub 10 is affixed to heater platform 24 by means of bosses 56 in tub 10 and aligned bosses 58 in platform 24, and connected by means of screws 60. On the underside of the floor 16 of the tub 10 is a pipe-like projection 62 which passes through an opening in the metal reflector 46 and opening 25 in heater platform 24 to engage the motor bracket 34 thus imparting vibratory motion of the motor directly to the arch support 20. Referring now to FIG. 6, the base platform 22 is provided with compartments 62 and 64 in which compartment 62 has an opening 70 in front wall 66 of the base 22 while compartment 64 has an opening 72 in the rear wall 68 of the base. Located within compartment 62 is a power cord 74 with removable remote control unit 76. In compartment 64 a standard power Cord 78 is shown which can be connected to any 110 Volt AC outlet. The remote control unit 76 can be placed in the opening 70 as shown in FIG. 5, or it may be removed from the opening, as seen in FIG. 6, in order to operate the foot bath from a distance. This arrangement is especially desirable for people who have difficulty bending down and operating the controls since the foot bath device can be operated from a sitting or standing position. As will be seen in FIGS. 2 and 7, the flexible sides 14 of the tub are folded over, as shown in full lines, for packing and transportation. When the foot bath is desired to be used, the sides 14 are pulled up all around the tub to the dotted line position shown in FIG. 2. Thus the depth of the tub 10 is approximately doubled thereby permitting a higher level of water in the tub. Furthermore, the vibratory, rounded projections spaced throughout the floor 16 of the tub 10, as well as the vibrating arch support 20, rejuvenate the soles and arches of the feet not only in warm water but in dry heat as well. FIG. 7 shows another embodiment of the present invention wherein the flexible sides 80 are accordion shaped so that tub 10 can be packed and shipped in a collapsed condition, as seen in full lines, or the accordion sides 80a can be pulled up to the enlarged tub position for use, as seen in dotted lines. While the invention has been disclosed and described with reference to several embodiments it will be apparent that changes and modifications may be made therein, and it is intended that the following claims cover each such variation and modification as falls within the true spirit and scope of the present invention.

1a

RELATED APPLICATIONS [0001] The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Ser. No. 61/868,769, filed Aug. 22, 2013, which is hereby incorporated by reference. COPYRIGHT NOTICE [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 the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND OF THE INVENTION [0003] 1. Field of the Invention [0004] The present disclosure relates generally to exercise devices and methods, and more particularly, to exercise devices and methods relating to resistance training. [0005] 2. Description of Related Art [0006] Resistance training is often considered an essential component of any fitness program. A variety of different types of equipment are available for resistance training including free weights, weight machines, resistance bands, etc. Many people prefer using resistance bands/stretchable cords because of their ease of use and portability. Resistance bands generally include handle(s) and a stretchable cord. However, current devices have a fixed point which can limit the exercises a user can perform. Furthermore, current devices are prone to error and thus do not provide consistent and accurate resistance. Additionally, the fixed point can create stress on the cable over time. BRIEF SUMMARY OF THE INVENTION [0007] In accordance with the present disclosure, interchangeable rotating free-motion fitness handle systems that may be used by individuals for exercise/physical fitness purposes such as resistance training, and methods for creating them are illustrated and described herein. [0008] In one example of an interchangeable and rotational resistance tube handle system, a handle used as an exercise device (“fitness handle”) which allows a resilient cord, or tube to move in a linear direction in order to maintain consistent resistance is disclosed. The fitness handle doesn't require a fixed point for the resistance tube. The fitness handle includes a grip and a frame. The frame includes an opening which allows the cord to slide. The cord/tube/etc has an adjoining portion which fits into the opening of the handle. [0009] In another embodiment, a hinge-locking tube anchor and pulley system is disclosed. The mechanism may allow users to create an anchor point from which they are able to generate resistance using resistance tubes. Key features can include, but are not limited to, the outer ends of a component which allow sewn webbing loop, or suitable design, to be applied and removed from the component when the webbing is not under tension. [0010] It should be noted that this disclosure should not be limited to the embodiments disclosed herein. A variety of other embodiments are also possible using the concepts enclosed herein. BRIEF DESCRIPTION OF THE FIGURES (NON-LIMITING EMBODIMENTS OF THE DISCLOSURE) [0011] FIG. 1 illustrates an embodiment of an interchangeable rotating free-motion fitness handle system; [0012] FIG. 2 illustrates the components of an interchangeable rotating free-motion fitness handle system; [0013] FIG. 3 illustrates an isometric view of one embodiment of a fitness handle and anchoring mechanism; [0014] FIGS. 4A-4B illustrates 3-dimensional views of one embodiment of a fitness handle and anchoring mechanism; [0015] FIG. 5 illustrates additional views of one embodiment of a fitness handle and anchoring mechanism; [0016] FIG. 6 illustrates several embodiments of an anchoring mechanism; [0017] FIGS. 7A-7C illustrate various embodiments of a fitness handle; [0018] FIG. 8 illustrates various views of components of an embodiment of an interchangeable rotating free-motion fitness handle system; [0019] FIG. 9 illustrates a more detailed view of the components of an embodiment of an interchangeable rotating free-motion fitness handle system; [0020] FIG. 10 illustrates a detailed isometric view of the components of one embodiment of a fitness handle; [0021] FIG. 11 illustrates detailed views of the components of a grip and a resistance band insert; [0022] FIG. 12 illustrates one embodiment of a hinge-locking tube anchor and pulley system; [0023] FIG. 13 illustrates one embodiment of a button lock ankle/wrist attachment; [0024] FIG. 14 illustrates one embodiment of a multi-attachment point fitness harness; and [0025] FIG. 15 illustrates one embodiment of a fitness harness. DETAILED DESCRIPTION [0026] Reference will now be made to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific exemplary embodiments. The principles described herein may, however, be embodied in many different forms. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. In some instances, example measurements are mentioned merely as illustrations of one or more embodiments and not to restrict the invention. Moreover, in the figures, like referenced numerals may be placed to designate corresponding parts throughout the different views. [0027] An interchangeable rotating free-motion fitness handle system may provide more accurate and consistent results because the tube/cord is always stretching linearly and thus, it's not manipulated by a fixed point. Additional muscles can be targeted by using the rotational features. [0028] In one example of an interchangeable rotating free-motion fitness handle system, a fitness handle that features an opening “oculus” that permits a resistance tube anchoring mechanism to enter into a sliding channel such that when combined with a rotational-hand-grip, allows a fitness resistance tube equipped with a resistance tube anchoring mechanism to both pan left and right, as well as hinge up and down as users move through exercise motions is disclosed. A “barb” that may be located next to the oculus prevents the resistance tube anchoring mechanism from exiting the sliding channel when under any tension. [0029] A resistance tube anchoring mechanism can be a mechanism that is applied to the tail end(s) of plugged resistance tubes which allows for said tubes to be connected to tube accessories including interchangeable handle(s) and any appropriate accessories. Such accessories may be equipped with, for example, a button-style fabric tube anchor point (see FIG. 12 for example). Of course, the length and resistance characteristics of the cables/stretch tubes the resistance tube anchoring mechanism is applied to can vary depending on the needs of the user. [0030] A hinge-locking tube anchor and pulley system may be a mechanism that allows users to create an anchor point from which they are able to generate resistance using resistance tubes. Key features can include, but are not limited to, the outer ends of a component which allow sewn webbing loop, or suitable design, to be applied and removed from the component when said webbing is not under tension. The component may be made of, but of course, is not limited to plastic. Other suitable materials may be also be used. [0031] When under tension, the webbing loops may secure the component as an anchor point, while allowing it to rotate, creating a pulley which responds to torsion friction applied by the fitness tube, thereby reducing wear/damage to the tube. This removable webbing loop design allows the hinge-locking tube anchor and pulley system to be secured to door hinges to create a superiorly secure anchor point, regardless of user orientation to the door. This allows the system to work on both open and closed doors, and offers the convenience of remaining in place when not in use, if the user so chooses. One additional feature is the larger pulley guide fins that define the outer limits of the pulley space. These large fins respond to pressure coming from the resistance tube, when in use, and adjust the orientation of the pulley to minimize wear on the tubes as different exercise movements are performed. [0032] A button-lock ankle/wrist Attachment allows a sewn or otherwise connected cuff to be attached to body regions of the user without requiring hand-grip. The key feature is the sewn button lock (slit) which receives the resistance tube anchoring mechanism and holds it securely when under tension, similar to the manner a shirt button behaves. The length of fabric between the sewn button lock and the sewn attachment point to the cuff creates a flexible ‘hinge’ which allows the system to remain secure as orientation to the tube forces change. [0033] Referring to FIG. 1 , an exemplary embodiment of an interchangeable rotating free-motion fitness handle system is illustrated. Interchangeable rotating free-motion fitness handle system includes cable/stretch tube/resistance band (“fitness tube”) 110 and interchangeable and rotational fitness handle system 120 . [0034] FIG. 2 illustrates the components of an interchangeable rotating free-motion fitness handle system. FIG. 2 includes an exemplary stretch tube/resistance band 110 , anchoring mechanism 210 and fitness handle 220 . Flat slide surface 211 of anchoring mechanism 210 is also illustrated. [0035] FIGS. 3-5 illustrate various views of fitness handle system 120 . Referring briefly to FIGS. 4A and 5 , opening 410 allows the anchoring mechanism 210 to enter into a sliding channel 420 such that when combined with a rotational-hand grip 430 allows a fitness tube to both pan left and right, as well as hinge up and down as users move through exercise motions. Barb 440 can prevent the anchoring mechanism 210 from exiting sliding channel 420 when under any tension. [0036] FIG. 6 illustrates several embodiments of anchoring mechanism 210 including pill 610 , barrel 620 , and cone 630 . As can be seen, fitness tube 110 can be inserted into the anchoring mechanisms 610 , 620 , and 630 . FIGS. 7A-7C illustrate various embodiments of a fitness handle 220 . FIGS. 7A-7C also illustrate more detailed views of some embodiments of sliding channel 710 and rotational-hand grip 720 . FIG. 8 illustrates various views of components of an embodiment of an interchangeable rotating free-motion fitness handle system. [0037] FIG. 9 illustrates a more detailed view of the components of an embodiment of an interchangeable rotating free-motion fitness handle system. This embodiment of an interchangeable rotating free-motion fitness handle system includes clip lock 910 , plastic grip with TPR overmold 920 , frame/main body 930 , connection bar 940 and anchoring mechanism 210 . Plastic grip with TPR overmold 920 may provide a comfortable grip to a user and may not be required. While this embodiment uses a plastic grip with TPR overmold, numerous alternative grips are also possible within the scope of the invention. The anchoring mechanism 210 includes resistance band insert 950 for inserting a resistance band. Clip lock 910 may be made from a variety of different materials. In one embodiment clip lock 910 is made of plastic. Other materials may be used within the scope of the invention. Additionally, any specific measurements in this figure and others are illustrated to assist in the understanding of the invention and not to restrict or in any way limit the invention. [0038] FIG. 10 illustrates detailed views of the components of one embodiment of a fitness handle. Clip lock 910 , main body 930 , and connection bar 940 are further broken down to illustrate the components in detail. Once again, measurements in FIG. 10 are illustrated to assist in the understanding of the invention and not to restrict or limit the invention. [0039] FIG. 11 illustrates detailed views of the components of grip 920 and resistance band insert 950 . FIG. 12 illustrates one embodiment of a fitness cable anchor and pulley system. Multi cable pulley 1210 may be designed such that it is wear reducing, thus increasing the life of the system. A rib 1220 may be added for strength purposes. Loop 1230 may “lock” onto the pulley 1210 contour when under tension, and may completely encompass the hinge for added safety. Loop 1230 may be sewn. The material of loop 1230 may be made of nylon but any other suitable material can also be used. The system may be used on both sides of the door 1240 . For example, an open door install may be configured to stay up when the door is opened or not in use. [0040] FIG. 13 illustrates one embodiment of a button lock ankle/wrist attachment. In this embodiment, a Velcro strap with a soft-inner-backer is used. FIG. 14 illustrates one embodiment of a multi-attachment point fitness harness. FIG. 15 illustrates one embodiment of a 360 degree rotating fitness harness. [0041] While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible within the scope of the invention. Accordingly, the invention is not to be restricted, except as set forth in the following claims.

1a

[0001] This application is a divisional of application Ser. No. 11/547,055, filed Oct. 2, 2006, which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Technical Field [0003] The present invention relates to a connector-attached syringe, a connector used for a syringe and a syringe. [0004] 2. Background [0005] In the medical field, syringes (i.e., medical instruments for injection) are used in a variety of different ways. [0006] For example, in a typical syringe, a female taper connector, such as a needle hub having a needle tube, is generally attached to a luer part located at the tip of syringes, and such syringes are used to draw blood from patients and to inject medication held in the syringes to patients. [0007] In addition, syringes may be used in a system referred to as a pipeline system, such as a transfusion line system and a blood collection line system. In the pipeline system, a syringe is connected to an external port of the line system, and then medication in the syringe is applied therefrom, or reversely fluid is drawn from the line. To connect a syringe to such a line system, a direct connection method (also known as luer slip) and a fixed connection method are used. In the direct connection method, the luer part is inserted directly into the port of the line system. In the fixed connection method, a luer part 1141 L of a syringe 1000 L is connected to a port 1200 L by screwing them together using a connector (locknut) 1130 L, as shown in FIGS. 41A to 41C . [0008] Prefilled syringes are also used in medical practices. Prefilled syringes are syringes containing prefilled medication in the syringe body. In this case, the nozzle tip of the syringe body is sealed by resin, for example, and the tip is opened before use and a plunger is inserted into the opening to thereby discharge the medication. Such prefilled syringes facilitate a rapid procedure by reducing the trouble and time required for administration of medication to patients and medication mixing. [0009] As to syringes connectable to the port of the above-mentioned line system in a fixed manner (referred to as luer-lock syringes), it is often the case that a locknut is already attached to the luer part. A stepped portion, whose diameter is different from that of the rest of the luer part, is provided in the luer part. The luer part is preliminarily inserted into the locknut, which is kept in place by the stepped portion. This structure is adopted in order to reliably connect the syringe and the line system and enable a quick connection operation. [0010] However, such a connector-attached syringe has a problem that the luer part cannot be connected to the direct connection port since the locknut is in the way, as shown in FIG. 42 . [0011] Another problem is that, when attempting to attach a needle hub to the connector-attached syringe at the luer part, the user cannot see the right positional relationship between the luer part and the needle hub since the lock nut is in the way, as shown in FIG. 43 , and cannot connect the luer part and needle hub successfully. In addition, since the locknut is set on the luer part, the length of a portion of the luer part exposing outside is insufficient, which leads to a problem of not being able to make the needle hub adequately hold onto the luer part. [0012] Thus, immediate improvement is desired in the versatility of locknut-attached syringes due to the requirements for speedy and accurate responses in medical field. SUMMARY OF THE INVENTION [0013] One Embodiment of the present invention includes: a syringe connectable to a port in a fixed manner as well as capable of demonstrating high operational performance even in the case of direct connection where a connector is not used; a connector used for the syringe; and a syringe able to attach the connector thereto. [0014] In order to solve the above problems, one embodiment of the present invention is a connector-attached syringe having a connector for connecting a syringe unit to a port. The connector is disposed at a luer part in the syringe unit which includes a syringe body and a plunger. Here, the luer part includes an engaging portion for engaging with the connector. The connector includes a first opening for engaging with the engaging portion in the syringe axial direction and a second opening larger than the first opening and allowing for the luer part to be freely insertable and removable thereto and from in the syringe axial direction. The first and second openings communicate with each other. In some embodiments, the first and second openings may communicate with each other via a passage. [0015] Furthermore, in the present invention, the engaging portion may be a step positioned between a tip and a base of the luer part. [0016] First, according to such structures of the present invention, the luer part is inserted into the second opening (insertion hole) of the connector, and then slid into the first opening (engaging hole) so that the base side of the luer part next to the engaging portion is fitted into the engaging hole of the connector, and whereby the connector is attached to the syringe while these two are engaged with each other. Thus, the user is able to attach the connector to the syringe and connect the syringe, using the connector, to a fixed connection port of a transfusion line system or the like. [0017] Second, in one embodiment, the connector can be readily detached from the luer part engaged with the engaging hole of the connector by relatively moving the luer part to the insertion hole. [0018] Thus, the connector can be detached from the luer part so as not to be in the way when the luer part is connected to the direct connection port. As a result, the luer part can be reliably connected to a direct connection port of a transfusion line system or the like where a connector is not used. Thus, the syringe of the present invention exhibits high versatility. [0019] A prefilled syringe having a conventional structure has problems regarding operational performance such as the connector obstructing the view of the user, thus making it difficult to determine the positioning of the luer part and the needle hab. Additionally, the needle hub cannot be deeply placed in and attached to the luer part due to the presence of the connector. However, the present invention is able to fundamentally solve these conventional problems since the connector is readily detachable from the connector. [0020] Additionally, in one embodiment, the passage is provided between the first and second openings so that these openings communicate with each other. Herewith, the luer part is forcedly shifted through the passage and moved to the engaging hole to be thereby reliably fitted when the syringe is used. [0021] To solve the above problems, one embodiment of the present invention is also a connector-attached syringe having a connector for connecting a syringe unit to a port. The connector is disposed at a luer part in the syringe unit which includes a syringe body and a plunger. Here, a first engaging portion for engaging with a second engaging portion on the connector is disposed on the outer peripheral surface of the syringe body. When an external force is applied, according to a predetermined operation, to one of the connector and the syringe unit in a direction different from a syringe axial direction, the engagement of the first and second engaging portions is released. [0022] Here, the first engaging portion may be, on the outer peripheral surface of the body of the syringe, a tip portion of the luer part, which has a larger diameter than the remaining portion (a stepped region in which a convex and a concave portions are provided side by side). [0023] Specifically, a body of the connector may be tubular, and the second engaging portion may be on an extension portion which extends from the body of the connector. Here, the first and second engaging portions are engaged with each other by inserting the luer part into the body of the connector and elastically contacting the extension portion with the outer peripheral surface of the syringe body. The engagement is released when the second engaging portion is detached from the outer peripheral surface by performing the predetermined operation on one of the connector and the syringe unit. [0024] First, according to such a structure of the present invention, the connector can be attached to the syringe while these two are engaged with each other by inserting the luer part into the connector and engaging the second engaging portion of the connector with the first engaging portion of the body of the syringe. Thus, the user is able to engage the connector with the syringe and connect the syringe, using the connector, to a fixed connection port of a transfusion line system or the like. [0025] Second, in one embodiment of the present invention, an external force is applied to the connector in a direction different from the syringe axial direction (e.g. in the syringe radial direction) according to a predetermined operation to detach the second engaging portion of the connector provided, for example, on the extention portion from the first engaging portion on the syringe. Herewith, the first and second engaging portions are disengaged, and whereby the connector can be readily detached from the luer part. [0026] Thus, the connector can be detached from the luer part so as not to be in the way when the luer part is connected to the direct connection port. As a result, the luer part can be reliably connected to a direct connection port of a transfusion line system or the like where a connector is not used. Thus, the syringe of the present invention exhibits high versatility. [0027] A prefilled syringe having a conventional structure has problems regarding operational performance such as that the connector obstructs the view of the user and makes it difficult to determine the positioning of the luer part and the needle hab and that the needle hub cannot be deeply placed in and attached to the luer part due to the presence of the connector. However, embodiments of the present invention are able to fundamentally solve these conventional problems since the connector is readily detached from the connector. [0028] To solve the above problems, embodiments of the present invention are also a connector-attached syringe having a connector attached to a luer part jutting out from a syringe unit which includes a syringe body and a plunger. The connector is used for fixedly holding the syringe unit on a port. Here, the luer part includes an engaging portion for engaging with the connector. The connector includes a tubular body portion with a base and a constraint portion encircling a periphery of the body portion and exerting constraint effects on the base by shifting in the axial direction of the body portion. The base includes a plurality of swingable petal-shaped members. In a first state where the petal-shaped members are closed due to the constraint effects exerted on the base, the engaging portion is engaged with the petal-shaped members in the axial direction. In a second state where the petal-shaped members are open due to the base being free from the constraint effects, the luer part is freely insertable and removable into and from the connector in the axial direction via an open hole formed in a substantially central region of the base when the petal-shaped members are open. [0029] As to embodiments of the present invention, the constraint portion may be a nut having a screw on an internal peripheral surface thereof. Here, the body portion is in the shape of a substantial cylinder, and has a screw, which corresponds to the nut, on a section of the outer peripheral surface of the cylinder. The section is a range where the constraint portion is movable. In the first state, part of the body portion corresponding to the section is closed, taking on a shape of a cylinder. In the second state, the part of the body portion is open, spreading like open tweezers towards the base in the axial direction. [0030] Here, in the connector-attached syringe, the luer part may have, on the base side thereof, a reduced-diameter section, and the engaging portion may be a step created by the reduced-diameter section. [0031] Furthermore, one embodiment of the present invention is a connector for fixedly holding a syringe unit on a port and being disposed at a luer part jutting out from the syringe unit which includes a syringe body and a plunger. The connector comprises: a tubular body portion with a base; and a constraint portion encircling a periphery of the body portion and exerting constraint effects on the base by shifting in the axial direction of the body portion. Here, the base of the body portion includes a plurality of swingable petal-shaped members. In a first state where the petal-shaped members are closed due to the constraint effects exerted on the base, the luer part is engaged with the petal-shaped members in the syringe axial direction. In a second state where the petal-shaped members are open due to the base being free from the constraint effects, the luer part is freely insertable and removable into and from the connector via an open hole formed in a substantially central region of the base when the petal-shaped members are open. [0032] In the connector above, the constraint portion may be a nut having a screw on an internal peripheral surface thereof. Here, the body portion is in the shape of a substantial cylinder, and has a screw, which corresponds to the nut, on a section of the outer peripheral surface of the cylinder. The section is a range where the constraint portion is movable. In the first state, part of the body portion corresponding to the section is closed, taking on a shape of a cylinder, and in the second state, the part of the body portion is open, spreading like open tweezers towards the base in the axial direction. [0033] One embodiment of the present invention is also a procedure method for treatment and diagnosis using the connector-attached syringe above. [0034] With the connector-attached syringe of embodiments of the present invention, the connector can readily change the state between the first and the second states. Accordingly, the connector-attached syringe is capable of engaging the luer part of the syringe with the petal-shaped members of the base as well as making the luer part freely insertable and removable via the open hole on the base. That is, the connector-attached syringe allows for a selective use of the syringe between the luer-lock type and the luer-slip type according to the connection style of a port on which the syringe is to be fixedly held. [0035] As to the connector-attached syringe of embodiments of the present invention, the connector can be thus freely attached and detached according to the connection style of the port, and the detached connector can be used with another syringe. This results in a reduction in the cost burden on the user but does not cause a decrease in work performance when the syringe is used. In addition, the connector-attached syringe of the present invention can be connected to a port in either the luer-slip style or the luer-lock style, having high versatility for connection with a port. [0036] Since having the same structure as the connector attached to the luer part in the connector-attached syringe above, the connector of one embodiment of the present invention also has similar advantageous effects as described above. [0037] Therefore, the connector in one embodiment of the present invention is effective to enhance the versatility of the syringe when it is fixedly held on a port. [0038] Furthermore, one embodiment of the present invention is a connector-attached syringe having a connector attached to a luer part jutting out from a syringe unit which includes a syringe body and a plunger. The connector is used for fixedly hold the syringe unit on a port. Here, the luer part includes an engaging portion for engaging with the connector. The connector includes a plurality of components, which individually have interlocking members for coupling mechanisms. The interlocking members are interlocked with each other to thereby couple the components and make the connector in the shape of a tube having a base. When made in the shape of the tube, the connector engages with the engaging portion of the luer part. When the coupling of the components is released, the luer part is freely insertable and removable into and from the connector. [0039] As to the present invention, in the above-mentioned connector-attached syringe, the components may be symmetrical to each other and have end portions facing to each other. Here, a cutout is disposed on each of the end portions. The cutouts face to each other to form an engaging hole, which engages with the engaging portion of the luer part. [0040] As to the present invention, in the above-mentioned connector-attached syringe, at least one of the coupling mechanisms may include a locking tab and a locked tab which interlock with each other when the components are coupled. [0041] As to the present invention, in one of the above-mentioned connector-attached syringes, the luer part may have, on a base side thereof, a reduced-diameter section, and the engaging portion may be a step created by the reduced-diameter section. [0042] Furthermore, one embodiment of the present invention has a connector for fixedly holding a syringe unit on a port and being disposed at a luer part jutting out from the syringe unit which includes a syringe body and a plunger. The connector comprises: a plurality of components, which individually have interlocking members for coupling mechanisms. The interlocking members interlock with each other to thereby couple the components and make the connector in the shape of a tube having a base. Here, when made in the shape of the tube, the connector engages with the luer part. When the coupling of the components is released, the luer part is freely insertable and removable into and from the connector. [0043] As to the present invention, in the above-mentioned connector, the components may be symmetrical to each other and have end portions facing to each other. Here, a cutout is disposed on each of the end portions, and the cutouts face to each other to form an engaging hole, which engages with an engaging portion of the luer part. [0044] As to the present invention, in the above-mentioned connector, at least one of the coupling mechanisms may include a locking tab and a locked tab which interlock with each other when the components are coupled. [0045] Furthermore, one embodiment of the present invention is a procedure method for treatment and diagnosis using the connector-attached syringe above. [0046] The connector-attached syringe of this embodiment of the present invention has a structure in which the connector is freely attachable and detachable to and from the luer part of the syringe simply by changing the state of the connector between the state where the multiple components are coupled to form the tube with a base and the state where the coupling is released. Accordingly, the connector-attached syringe allows for a selective use of the syringe between the luer-lock type and the luer-slip type according to the connection style of a port on which the syringe is to be fixedly held. [0047] Additionally, with the connector-attached syringe, the connector may be detached from the syringe after used or when not used, and then the detached connector may be used with another syringe. [0048] Herewith, the connector-attached syringe of the present invention reduces the cost burden on the user but does not cause a decrease in work performance when the syringe is used. In addition, the connector-attached syringe of the present invention can be connected to a port in either the luer-slip style or the luer-lock style, exhibiting high versatility for connection with a port. [0049] Similarly to the connector attached to the connector-attached syringe above, the connector of the present invention can be easily attached and detached to and from the luer part of the syringe simply by changing the state of the connector between the state where the multiple components are coupled to form the tube with a base and the state where the coupling is released. Herewith, the connector can be attachable and detachable according to need—for example, the connector is engaged with the luer part of the syringe when the syringe and port are connected in the luer-lock style, and the connector is disengaged when they are connected in the luer-slip style. [0050] As a result, the connector of the present invention is effective to enhance the versatility of the syringe for connection with a port. [0051] In order to solve the above problems, in one embodiment of the present invention is a connector-attached medical syringe having a tubular connection supporting member and a pin for increasing, when a syringe unit including a syringe body and a plunger is connected to a port, a connecting force between a luer part of the syringe unit and the port. The luer part is inserted into the port. Here, the connection supporting member includes a first insertion hole disposed on the outer peripheral surface thereof and a second insertion hole disposed on an end portion thereof. The first insertion hole is for the pin to be inserted thereto. The pin includes a fit portion for being fitted with the luer part. The syringe unit freely changes a state thereof between (i) a connector hold state, in which, when the luer part is inserted into the second insertion hole, the pin is inserted into the first insertion hole along an insertion path until the fit portion is fitted with the luer part and (ii) a connector release state, in which the fitting of the fit portion and the luer part is released by pulling the pin out from the first insertion hole. [0052] The syringe of the present invention may be a connector-attached medical syringe having a tubular connection supporting member and a pin for increasing, when a syringe unit including a syringe body and a plunger is connected to a port, a connecting force between a luer part of the syringe unit and the port. The luer part is inserted into the port. Here, the connection supporting member includes a first insertion hole disposed on the outer peripheral surface thereof and a second insertion hole disposed on an end portion thereof. The first insertion hole is for the pin to be inserted thereto. The pin includes a fit portion for being fitted with the luer part. The syringe unit freely changes a state thereof between (i) a connector hold state, in which, when the luer part is inserted into the second insertion hole, the pin is inserted into the first insertion hole along an insertion path until the fit portion is fitted with the luer part and (ii) a connector release state, in which the fitting of the fit portion and the luer part is released by pulling the pin out from the first insertion hole. [0053] Herewith, the syringe can be used as a so-called luer-slip syringe by pulling out the pin and thereby disengaging the connector from the syringe. In addition, the syringe can be used also as a so-called luer-lock syringe by inserting the pin into the connector and thereby engaging the luer part and the connector. [0054] That is, since the syringe functions as either type, its versatility increases. [0055] In addition, the luer part may be in the shape of a substantially cylinder locally having a reduced-diameter section in vicinity of a central region or a base portion thereof. Here, the insertion path of the pin is a line connecting facing sections on the outer peripheral surface and passing in vicinity of the central axis of the connection supporting member. The fitting is made when the fit portion is fitted with the reduced-diameter section of the luer part in the vicinity of the central axis. [0056] According to the structure, the central axis of the luer part coincides with or come close to that of the connector. [0057] As to a connection-target instrument in the luer-lock style, an insertion point for the luer part is generally located in the middle of an engaging structure such as a threaded portion or a groove portion for engagement. Therefore, since the central axes of the luer part and connector substantially coincide, the insertion of the luer part into the port can be performed while the pin is being fitted with the luer part. [0058] In addition, the fitting may be made so that the pin is freely rotatable around the central axis of the reduced-diameter section. [0059] Accordingly, the syringe and the connection-target instrument in the luer-lock style can be connected and fixed to each other simply by rotating the connector without rotating the syringe itself. [0060] In addition, the pin may include a handle portion to be grasped in a case of insertion and pullout. This facilitates easy insertion and pullout of the pin. BRIEF DESCRIPTION OF THE DRAWINGS [0061] FIG. 1 is a cross sectional view showing a structure of a prefilled syringe of Embodiment 1; [0062] FIG. 2 shows the way to attach a locknut of Embodiment 1 to the prefilled syringe; [0063] FIG. 3 shows the prefilled syringe of Embodiment 1 connected to a fixed connection port; [0064] FIG. 4 shows the prefilled syringe of Embodiment 1 connected to a direct connection port; [0065] FIG. 5 shows the prefilled syringe of Embodiment 1 to which a conventional needle hub is attached; [0066] FIG. 6 shows a structure of a locknut of Embodiment 2; [0067] FIG. 7 shows a structure of a locknut of Embodiment 3; [0068] FIG. 8 shows a structure of a locknut of Embodiment 4; [0069] FIG. 9 shows a structure of a locknut of Embodiment 5; [0070] FIG. 10 is a cross sectional view showing a structure of a prefilled syringe of Embodiment 6; [0071] FIG. 11 shows the way to attach a locknut of Embodiment 6 to the prefilled syringe; [0072] FIG. 12 shows the locknut of Embodiment 6 fitted to the prefilled syringe; [0073] FIG. 13 is a cross sectional view of the prefilled syringe and locknut of Embodiment 6; [0074] FIG. 14 is a cross sectional view showing the prefilled syringe of Embodiment 6 connected to a direct connection port of a transfusion line system; [0075] FIG. 15 is a cross sectional view showing a luer part of the prefilled syringe of Embodiment 6 to which a needle hub is attached; [0076] FIG. 16 shows a structure of a locknut and a prefilled syringe of Embodiment 7; [0077] FIG. 17 shows a structure of a locknut and a prefilled syringe of Embodiment 8; [0078] FIG. 18 shows a structure of a locknut and a prefilled syringe of Embodiment 9; [0079] FIG. 19 is a cross sectional view showing a prefilled syringe and a locknut of Embodiment 10; [0080] FIG. 20 is an assembly drawing of the prefilled syringe, a fixture and the locknut of Embodiment 10; [0081] FIG. 21 shows the way to connect the prefilled syringe of Embodiment 10 to the fixed connection port; [0082] FIG. 22 shows the state of the locknut being disengaged from the fixture of Embodiment 10; [0083] FIG. 23 shows the prefilled syringe of Embodiment 10 connected to the direct connection port; [0084] FIG. 24 shows the prefilled syringe of Embodiment 10 to which a conventional needle hub is attached; [0085] FIG. 25 shows a structure of a locknut of Embodiment 11; [0086] FIG. 26 shows a structure of a locknut of Embodiment 12; [0087] FIG. 27A is a lateral side view (with a partial cross sectional view) of a connector 1 of Embodiment 13; and FIG. 27B is a front view of the connector 1 ; [0088] FIG. 28A is a lateral side view (with a partial cross sectional view) of the connector 1 before the connection with a syringe 5 of Embodiment 13; and FIG. 28B is a lateral side view (with a partial cross sectional view) of the connector 1 after the connection with the syringe 5 of Embodiment 13; [0089] FIG. 29 is a perspective view showing a relation between the connector 1 and an extension tube 6 when they are to be connected to each other, according to Embodiment 13; [0090] FIG. 30 is a lateral side view showing a coinfusion port 7 or an injection needle is to be connected to the syringe 5 J in luer-slip style without using the connector 1 , according to Embodiment 13; [0091] FIG. 31A is a perspective view of a connector 1 of Embodiment 14; and FIG. 31B is a front view of the connector 1 ; [0092] FIG. 32 is a perspective view showing a relationship between the connector 1 and an extension tube 6 when they are to be connected to each other, according to Embodiment 14; [0093] FIG. 33 is a lateral side view showing a coinfusion port 7 or an injection needle 8 is to be connected to the syringe 5 K in the luer-slip style without using the connector 1 , according to Embodiment 14; [0094] FIG. 34 is a perspective view showing a relation between a connector 2 of Embodiment 15 and the syringe 5 ; [0095] FIG. 35 is a perspective view showing a shape of a connector 3 of Embodiment 16; [0096] FIG. 36 illustrates usage of a syringe according to Embodiment 17; [0097] FIG. 37 shows the way of a coupling pin being inserted into a lock part according to Embodiment 17; [0098] FIG. 38 shows the way of the syringe of Embodiment 17 being inserted into a coinfusion port in the luer-slip style; [0099] FIG. 39 shows an example of realizing a lock mechanism of a syringe of Embodiment 18, using another structure other than a screw nut; [0100] FIG. 40 shows an example where the lock part and syringe are engaged with each other using a coupling pin of Embodiment 19, the shape of which is different from that of the coupling pin of Embodiment 17; [0101] FIG. 41 illustrates usage of a conventional luer-lock syringe; [0102] FIG. 42 shows a structure of a conventional locknut and a prefilled syringe; and [0103] FIG. 43 shows a structure of a conventional locknut and a prefilled syringe. DETAILED DESCRIPTION OF THE INVENTION [0104] The following sequentially describes Embodiments 1 through 19 of medical syringes of the present invention with the aid of drawings. 1. Embodiment 1 1-1. Overall Structure of Prefilled Syringe [0105] FIG. 1 is a cross sectional diagram showing structures of a prefilled syringe and a connector (a locknut) according to Embodiment 1. Note that, here, a structure is adopted in which a prefilled syringe and a locknut are combined, however, the present invention may be applied to syringes other than prefilled syringes. For convenience of explanation, a plunger 40 is shown here in normal lateral view rather than in cross section. [0106] As shown in FIG. 1 , a prefilled syringe 1 may comprise a syringe body 10 , the plunger (also referred to as a piston) 40 and the like. [0107] In this embodiment, the syringe body 10 is a tubular body formed by injection molding a material with high chemical resistance, such as polyethylene, polypropylene, polycarbonate or polyvinyl chloride. The tip end of the syringe body 10 is sealed by a top face portion 110 , and a luer part 120 juts or extends out from the center of the top face portion 110 . [0108] On the other hand, an opening 12 may be formed at the posterior end of the syringe body 10 . Although the luer part 120 is formed by drawing to basically give a tapered shape, a stepped portion 123 is provided in a part of the tapered shape, which thereby forms a luer base portion 121 having a smaller diameter and a luer tip portion 122 located on the tip side of the luer part 120 having a larger diameter. [0109] A locknut 30 , to be hereinafter described, may be fitted to the stepped portion 123 . In addition, the luer tip portion 122 may be formed in a tapered shape in compliance with ISO6/100 so that the regular needle hub 20 can be attached easily. In FIG. 1 , a cap 20 is attached to the tip of the luer part 120 . [0110] In the following description, the longitudinal direction of the syringe body 10 is referred to as an “axial direction” while a direction perpendicular to the axial direction is referred to as a “radial direction”. [0111] The plunger 40 can be made of a resin material with high chemical resistance, similarly to the syringe body 10 , and includes a plunger body 42 having a cruciform cross sectional shape for the purpose of reinforcement, at each end of which are formed disk-shaped end pieces having main surfaces in the radial direction. One of the end pieces is a pressing end portion 41 to be pressed by the user with a thumb, and the other end piece is a head portion 43 that is inserted inside the syringe body 10 in the axial direction. [0112] A packing 44 is provided at the tip of the head portion 43 in a manner to make tight contact with the internal wall of the syringe body 10 . Here, medication 100 is held in the syringe body 10 , which is internally sealed by the packing 44 and the cap 20 . [0113] When using the prefilled syringe 1 having such a structure, the user removes the cap 20 to enable discharge of the medication 100 . As the user pushes the pressing end portion 41 of the plunger 40 into the syringe body 10 with a thumb, the medication 100 is discharged from the tip of the luer part 120 according to the depressed amount of the plunger 40 . 1-2. Structure of Locknut [0114] The prefilled syringe 1 of Embodiment 1 includes the locknut 30 , which is a connector easily detachable from the luer part 120 , and which is attached so as to engage, in the axial direction, with the stepped portion 123 of the luer part 120 . The locknut 30 is used in the medical field as a connection implement for connecting the prefilled syringe 10 to a fixed connection port of a transfusion line system or blood collection line system. [0115] The locknut 30 has a cylindrical form with a bottom, being formed by injection molding a resin material with high mechanical strength. A screw thread is cut on the internal surface of a lateral side portion 301 , which corresponds to the cylindrical part of the locknut 30 , to thereby form a female screw 3010 in compliance with, for example, ISO594-2. The female screw 3010 may engage with a male screw 5010 to be hereinafter described. [0116] A snowman-shaped hole 3020 formed by perforating two holes communicating with each other is provided on a main surface portion 302 that is the bottom of the locknut 30 (for detail, see FIG. 2 ). One of these two holes is a loose-insertion hole 3021 and is formed on the main surface portion 302 away from the center by perforation. The other hole is an engaging hole 3022 which is formed in the center of the main surface portion 302 by perforation. The loose-insertion hole 3021 has a diameter at least larger than that of the luer tip portion 122 so that the entire luer part 120 of the prefilled syringe 1 can be inserted into the hole with clearance therebetween. On the other hand, the engaging hole 2022 has a diameter slightly smaller than that of the luer tip portion 122 so that the stepped portion 123 of the luer part 120 is fitted thereto and the locknut 30 rotates with respect to the luer part 120 . A passage 303 is formed between the loose-insertion hole 3021 and engaging hole 3022 , having a diameter further smaller than that of the engaging hole 3022 . The width of the passage 303 is slightly smaller than the diameter of the luer base portion 121 so that the luer part 120 shifts to the passage 303 side only when more than a certain amount of force is applied to the luer base portion 121 . 1-3. Engagement of Syringe and Locknut [0117] FIG. 2A shows how to attach the locknut 30 to the syringe 1 and FIG. 2B shows the locknut 30 after the attachment. As to the locknut 30 having the above structure, when using the prefilled syringe 1 , the user first inserts the luer part 120 of the prefilled syringe 1 into the loose-insertion hole 3021 in the axial direction, as shown in FIG. 2A ( FIG. 2A shows that the luer part 120 is about to be inserted in the direction A, i.e. the axial direction). Since the loose-insertion hole 3021 has a diameter sufficiently larger than that of the luer tip portion 122 of the luer part 120 , the luer part 120 can be smoothly inserted into the locknut 30 . [0118] In the second step after the user has inserted the luer part 120 into the loose-insertion hole 3021 so as to assuredly insert the luer base portion 121 thereto, the user brings the lateral side of the luer base portion 121 into contact with the lateral surface of the loose-insertion hole 3021 and shifts the luer part 120 to the engaging hole 3022 via the passage 303 ( FIG. 2A also shows that the luer part 120 is to be shifted in the direction B). In this process, the luer base portion 121 is forcedly shifted through the passage 303 , then the stepped portion 123 shifts and becomes fitted into the small engaging hole 3022 . Since the diameter of the engaging hole 3022 matches that of the stepped portion 123 and the passage 303 exists between the engaging hole 3022 and loose-insertion hole 3021 , the stepped portion 123 of the luer part 120 abuts against the circumference of the engaging hole 3022 and is securely engaged in the axial direction, as shown in FIG. 2B . [0119] After the locknut 30 having the snowman-shaped hole 3020 is engaged with the syringe body 10 , these two can be readily detached from each other in the following manner. That is, the user shifts the luer part 120 from the engaging hole 3022 to the insertion hole 3021 as exerting some force on the luer part 120 . This operation can be performed in a reversible and simple fashion (for example, in one hand), and the user is therefore able to easily attach the locknut 30 to the prefilled syringe 1 when required, and detach the locknut 30 , when not required, to thereby use the prefilled syringe 1 alone. [0120] FIG. 3 is a cross sectional view showing that the prefilled syringe 1 is connected, using the locknut 30 , to a fixed connection port 50 of a transfusion line system. As the male screw 5010 of the port 50 is screwed into the female screw 3010 of the locknut 30 , the luer tip portion 122 of the luer part 120 of the prefilled syringe 1 comes in close contact with a packing 52 provided inside the port 50 , and eventually gets inserted into the transfusion line while pressing the packing 52 . At this point, in the locknut 30 , the circumference of the engaging hole 3022 exerts pressure on the stepped portion 123 of the luer part 120 so that they tightly engage with each other. Thus, even if some degree of tension is applied to the prefilled syringe 1 , the prefilled syringe 1 does not come apart from the port 50 along the axial direction. As a result, the user is able to safely push the plunger 40 into the syringe body 10 accordingly and deliver a required amount of medication 100 to the inside of the port 50 . [0121] On the other hand, FIG. 4 is a cross sectional view showing that the locknut 30 has been detached from the prefilled syringe 1 , which is then connected to a direct connection port 500 of a transfusion line system. Thus, according to Embodiment 1, since the locknut 30 has been taken off, or otherwise may be an obstacle, the luer tip portion 122 of the prefilled syringe 1 is properly and tightly held by the packing 52 in the port 500 , which makes a suitable connection between the prefilled syringe 1 and the port 500 . [0122] FIG. 5 is a cross sectional view showing that the locknut 30 has been detached from the prefilled syringe 1 and a needle hub 60 is attached to the luer tip portion 122 . The needle hub 60 has a structure in which a socket portion 61 composed of a resin material and formed to match the shape of the luer tip portion 122 holds a needle tube 62 which is an injection needle. With the conventional prefilled syringe in which the locknut is fixed and cannot be detached therefrom as shown in FIG. 43 , the locknut obstructs the view of the user and makes it difficult to determine the positioning of the luer part and the needle hub, thereby creating the danger of the user mistakenly pricking himself/herself and coming into contact with infectious material. In addition, the conventional problem that the needle hub cannot be deeply placed in and attached to the luer part due to the presence of the locknut can be fundamentally solved by Embodiment 1 since the snowman-shaped hole 3020 enables easy detachment of the locknut 30 from the prefilled syringe 1 . Other Embodiments [0123] Note that although in Embodiment 1 the snowman-shaped hole is formed by circular insertion and engaging holes communicating with each other via the passage, the following embodiments are also within the scope of the present invention. 2. Embodiment 2 [0124] With a snowman-shaped hole 3020 a in a locknut 30 A of Embodiment 2 shown in FIG. 6 , arcs of a loose-insertion hole 3021 a and an engaging hole 3022 a are partially overlapped with each other, and two circumferences of these holes where they overlap form a passage 303 a. [0125] With the snowman-shaped hole 3020 a having such a shape, the present invention is able to achieve an equivalent effect to that of Embodiment 1. In addition, since the passage 303 a of Embodiment 2 is formed where the loose-insertion hole 3021 a and engaging hole 3022 a overlap, it is rather edged as compared with that of Embodiment 1, and the luer part 120 is reliably engaged with the engaging hole 3022 a due to the shape. 3. Embodiment 3 [0126] With a snowman-shaped hole 3020 b in a locknut 30 B according to Embodiment 3 shown in FIG. 7 , an engaging hole 3022 b is formed between two insertion holes 3021 b A and 3021 b B. Although arcs of the engaging hole 3022 b and each of the insertion holes 3021 b A and 3021 b B are partially overlapped with each other, these holes may be communicated with each other by passages therebetween. In addition, the insertion holes 3021 b A and 3021 b B need not have the same size and shape, but need to have sizes such that at least the stepped portion 123 of the luer part 120 can be inserted thereto with clearance therebetween. [0127] With the snowman-shaped hole 3020 b having such a structure, the user can detach the locknut 30 easily when using the syringe 1 since the luer part 120 can be shifted from the engaging hole 3022 b to either of the two insertion holes 3021 b A and 3021 b B. This results in reducing the operational load on the user. Embodiment 3 is expected to achieve a very high level of convenience especially in medical practices which require the user to handle the prefilled syringe 1 and locknut 30 in one hand based on the treatment method using the prefilled syringe 1 . 4. Embodiment 4 [0128] With a snowman-shaped hole 3020 c in a locknut 30 C of Embodiment 4 shown in FIG. 8 , a circular engaging hole 3022 c is communicated with a rectangular loose-insertion hole 3021 c via a passage 3023 c. [0129] With such a structure also, a similar effect to that of the locknut 30 of Embodiment 1 can be achieved. An additional advantage is that the user readily recognizes and distinguishes the loose-insertion hole 3021 c and engaging hole 3022 c without confusion and is able to properly use the locknut 30 C since the shapes of these holes are distinctly different. 5. Embodiment 5 [0130] With a snowman-shaped hole 3020 d in a locknut 30 D of Embodiment 5 shown in FIG. 9 , a circular engaging hole 3022 d is communicated with a hexagonal loose-insertion hole 3021 d via a passage 3023 d. [0131] With such a structure also, a similar effect to that of the locknut 30 of Embodiment 1 can be achieved. Similarly to Embodiment 4, since the shapes of the loose-insertion hole 3021 d and engaging hole 3022 d are distinctly different, the user readily recognizes and distinguishes these two holes without confusion and is able to properly use the locknut 30 D. Additional Particulars Regarding Embodiments 1 Through 5 [0132] Although the prefilled syringe 1 of the present invention has been explained with an example in which the needle hub 60 is attached after the locknut 30 being detached, the present invention is not limited to that case. Instead of a needle hub, a tubelike luer or a tube may be used. It is effective to attach, from the top, a cap or the like to the prefilled syringe 1 with a needle hub attached thereto so as to protectively cover the needle hub and needle tube for the purpose of avoiding accidental pricking. As such a cap, one similar to a cap for a vial container can be used. [0133] Each embodiment described above discloses a structural example of a connector (locknut) in which a screw thread is cut to form a female screw. However, the present invention is not confined to this structure, and the prefilled syringe 1 may be appropriately connected to the port of a line system using a discontinuous thread, a cup joint, or another structure. [0134] The luer part of the syringe used in the present invention does not necessarily have a circular cross section, and either one of the luer tip portion and the luer base portion or both have rectangular, elliptic, or triangle cross sections. Note however that it is preferable that the shape of the engaging hole be appropriately decided in accordance with the cross sectional shape of the stepped portion of the luer part so as to stably and reliably engage the luer part in the engaging hole of the locknut. 6. EMBODIMENT 6 6-1. Overall Structure of Prefilled Syringe [0135] FIG. 10 is a cross sectional view showing structures of a prefilled syringe and a connector (locknut) according to Embodiment 1. Note that Embodiment 6 has a structure in which a prefilled syringe and a locknut are combined, however, the present invention is applicable to syringes other than prefilled syringes. For convenience of explanation, the plunger 40 is shown here in normal lateral view rather than in cross section. [0136] The prefilled syringe 1 shown in the figure may comprise the syringe body 10 , the plunger (also referred to as a piston) 40 and the like. The syringe body 10 may be a tubular body formed by injection molding a material with high chemical resistance, such as polyethylene, polypropylene, polycarbonate or polyvinyl chloride. The tip end of the syringe body 10 is sealed by the top face portion 110 , and the luer part 120 formed by drawing to give a tapered shape juts or extends out from the center of the top face portion 110 . The luer part 120 is formed in a tapered shape in compliance with IS06/100 so that the normal needle hub 20 is easily attached thereto. In FIG. 10 , the cap 20 is attached to the tip of the luer part 120 . The prefilled syringe 1 of the present invention is configured, such that convex portions 101 and 102 and a concave portion 103 are provided side by side, situated closer to the luer part 120 , so as to encircle the circumference of the syringe body 10 . These portions are for engaging with the locknut 30 to be hereinafter described. [0137] On the other hand, the opening 12 is formed at the posterior end of the syringe body 10 . [0138] In the following description, the longitudinal direction of the syringe body 10 is referred to as an “axial direction” while a direction perpendicular to the axial direction is referred to as a “radial direction”. [0139] The plunger 40 is made of a resin material with high chemical resistance, similarly to the syringe body 10 , and includes the plunger body 42 having a cruciform cross sectional shape for the purpose of reinforcement, at each end of which are formed disk-shaped end pieces having main surfaces in the radial direction. One of the end pieces is the pressing end portion 41 to be pressed by the user with a thumb, and the other end piece is the head portion 43 that is inserted inside the syringe body 10 in the axial direction. [0140] The packing 44 is provided at the tip of the head portion 43 in a manner to make tight contact with the internal wall of the syringe body 10 . Here, medication 100 is held in the syringe body 10 , which is internally sealed by the packing 44 and the cap 20 . [0141] When using the prefilled syringe 1 having such a structure, the user removes the cap 20 to enable discharge of the medication 100 . As the user pushes the pressing end portion 41 of the plunger 40 into the syringe body 10 with a thumb, the medication 100 is discharged from the tip of the luer part 120 according to the depressed amount of the plunger. 6-2. Structure of Locknut [0142] The prefilled syringe 1 of Embodiment 6 is configured, such that the locknut 30 , which is a connector easily detachable from the luer part 120 , is attached thereto as shown in FIG. 10 . The locknut 30 is used in the medical field as a connection implement for connecting the prefilled syringe 10 to a fixed connection port of a transfusion line system or blood collection line system. [0143] The locknut 30 has a cylindrical shape having a bottom, and is formed by injection molding a resin material with high mechanical strength. A screw thread is cut on the internal surface of a lateral side portion 301 , which corresponds to the cylindrical part of the locknut 30 , to thereby form a female screw 3010 in compliance with, for example, ISO594-2. The female screw 3010 engages with the male screw 5010 to be hereinafter described. [0144] A rib 3020 having in the center a perforation with a size such that the luer part 120 can be inserted, leaving no space therebetween, is formed in the locknut 30 , and forms a bulkhead which divides the internal space of the locknut 30 into a syringe side and a port side. On the other hand, outside the locknut 30 , two plate-like arms 31 and 32 are formed parallel to the syringe body 10 in the axial direction to make T shapes with the rib. Tab projections 310 and 320 having triangular cross sections are formed on the inner sides of the tip ends of the arms 31 and 32 . The shape of the projections 310 and 320 is made to be complementary to that of the concave portion 103 of the syringe body 10 . 6-3. Detachment of Locknut from Syringe [0145] FIG. 11 shows the way of engaging the locknut 30 and the state of locknut 30 after the engagement. [0146] As to the locknut 30 having the above structure, when the prefilled syringe 1 is used, the user first inserts the luer part 120 into the locknut 30 (here, the luer part 120 is inserted in the center of the rib 3020 inside the locknut 30 ) as shown in FIG. 11 . At this point, the user makes sure that the luer part 120 is inserted so that the rib 3020 comes all the way to the base of the luer part 120 . [0147] In the second step, using the arms 31 and 32 extending from the locknut 30 , the user engages the projections 310 and 320 provided on the inner sides of the arms 31 and 32 with the concave portion 103 of the syringe body 10 by elastically contacting and fitting them with each other. The shape of the projection 310 and 320 is formed so as to conform to the convex portions 101 and 102 and the concave portion 103 , and therefore the locknut 30 is securely kept on the syringe body 10 by the engagement. [0148] FIG. 12 is a cross sectional view showing the prefilled syringe 1 that is, using the locknut 30 , connected to the fixed connection port 50 of a transfusion line system. As the male screw 5010 of the port 50 is screwed into the female screw 3010 of the locknut 30 , the tip of the luer part 120 of the prefilled syringe 1 is tightly pressing the packing 52 provided inside the port 50 , and eventually gets inserted into the transfusion line. The prefilled syringe 1 is not disengaged while in use because the syringe body 10 is securely fixed with the locknut 30 by the convex portions 101 and 102 , concave portion 103 , and projections 310 and 320 , and besides the luer part 120 is supported by the rib 3020 in the locknut 30 to keep the luer part 120 in place. As a result, the user is able to safely push the plunger 40 into the syringe body 10 accordingly and deliver a required amount of medication 100 to the inside of the port 50 . [0149] According to Embodiment 6, after being engaged with the syringe body 10 , the locknut 30 can be easily disengaged from the syringe 1 by performing a predetermined operation in the following manner. This operation can be performed in a reversible and simple fashion (for example, in one hand), and the user is therefore able to easily engage the locknut 30 with the prefilled syringe 1 when required, and detach the locknut 30 , when not required, to thereby use the prefilled syringe 1 alone. [0150] In a specific method of disengaging the locknut 30 (the predetermined operation), the user presses the arms 31 and 32 on the anterior side of the syringe 1 , as shown in FIG. 13 , which is a cross sectional view of the syringe 1 and locknut 30 . In this embodiment, “the principle of leverage” may be applied, with the centers of the arms 31 and 32 being fulcrums while the points where the projections 310 and 320 abut on the convex portions 101 being working points. Accordingly, the ends of the arms 31 and 32 where the projections 310 and 320 are provided warp away from the syringe body 10 (i.e. an external force is applied to the locknut 30 in a direction different from the syringe axial direction). Herewith, the projections 310 and 320 detach and come free, at least, from the convex portion 102 and concave portion 103 . While maintaining this state, the user is able to pull out the locknut 30 from the syringe 1 with a little force. Note that the locknut 30 can be easily disengaged from the syringe body 10 by spreading outward the ends of the arms 31 and 32 with the projections 310 and 320 by fingers, instead of pressing the arms 31 and 32 on the anterior side of the syringe 1 . [0151] It is desirable that the arms 31 and 32 be provided on the locknut 30 so that T shapes are formed with the rib, and points where the arms 31 and 32 abut on the rib become fulcrums. This, the user can easily disengage the locknut 30 from the syringe body 10 by pushing the posterior ends of the arms 31 and 32 to spread the anterior ends thereof. [0152] FIG. 14 is a cross sectional view showing that the prefilled syringe 1 may be connected to the direct connection port 500 of a transfusion line system after the locknut 30 has been detached therefrom according to the above method. Thus, in Embodiment 6, since the locknut 30 has been removed, or may otherwise be an obstacle, the luer part 120 of the prefilled syringe 1 is properly and tightly held by the packing 52 in the port 500 , which makes a suitable connection between the prefilled syringe 1 and the port 500 . [0153] FIG. 15 is a cross sectional view showing that the needle hub 70 is attached to the luer part 120 after the locknut 30 has been detached from the prefilled syringe 1 . The needle hub 70 has a structure in which a socket portion 71 composed of a resin material and formed to match the shape of the luer part 120 holds a needle tube 72 which is an injection needle. With the conventional prefilled syringe in which the locknut is fixed and cannot be detached therefrom as shown in FIG. 43 , the locknut obstructs the view of the user and makes it difficult to check on the positioning of the luer and the needle hub, thereby creating the danger of the user mistakenly pricking himself/herself and coming into contact with infectious material. In addition, the conventional problem that the needle hub cannot be deeply placed in and attached to the luer part due to the presence of the locknut can be fundamentally solved by Embodiment 6 since the user can readily detach the locknut 30 from the prefilled syringe 1 by handling the arms 31 and 32 in a simple fashion. Other Embodiments [0154] Note that Embodiment 6 has a structure in which one projection 310 or 320 having a triangular cross section is formed on the end of each arm 31 and 32 and fitted with the convex portions 101 and 102 and concave portion 103 of the syringe body 10 . However, the following embodiments are also within the scope of the present invention. 7. Embodiment 7 [0155] As to Embodiment 7 shown in FIG. 16 , although the structure of the locknut 30 is substantially similar to that of Embodiment 1, the syringe body 10 has a slightly different structure. Embodiment 7 is characterized by a male screw portion 104 formed with a helical convex portion provided on the outer surface of the syringe body 10 . [0156] With using the syringe body 10 having the male screw portion 104 also, the present invention is able to achieve an equivalent effect to that of Embodiment 6. In addition, Embodiment 7 allows for a slight adjustment of the positional relationship between the syringe body 10 and the locknut 30 by changing the degree of screwing of the male screw portion 104 into the locknut 30 (i.e. how far the male screw portion 104 is screwed into the locknut 30 ). Consequently, Embodiment 7 achieves a good connection of the syringe 1 to a fixed connection port corresponding to the luer part 120 shorter than a conventional one. 8. Embodiment 8 [0157] As to Embodiment 8 shown in FIG. 17 , although the structure of the locknut 30 is substantially similar to that of Embodiment 6, the syringe body 10 has a slightly different structure. Embodiment 8 is configured to have a concave portion 105 which is formed by concaving the outer surface of the syringe body 10 . [0158] With using the syringe body 10 having the concave portion 105 also, Embodiment 8 is able to achieve an equivalent effect to that of Embodiment 6. In addition, since the syringe body 10 of Embodiment 8 has a smooth surface without the convex portions 101 and 102 , a problem such as the convex portions 101 and 102 of the syringe body 10 catching the user's clothes while in use can be avoided. It is a matter of course that the syringe body 10 according to Embodiment 8 must have enough thickness for the formation of the concave portion 105 . 9. Embodiment 9 [0159] As to Embodiment 9 shown in FIG. 18 , although the structure of the syringe body 10 is substantially similar to that of Embodiment 6, a locknut 35 has a slightly different structure. Embodiment 9 is characterized by projection sets 351 and 352 , each of which includes multiple projections, formed on the inner sides of the tip ends of arms 36 and 37 , respectively. Here, in the respective sets 351 and 352 , the projections are provided with a predetermined distance therebetween. [0160] With using the syringe body 10 having the locknut 35 also, Embodiment 9 is able to achieve an equivalent effect to that of Embodiment 6. Especially since the multiple projections of the sets 351 and 352 are fitted with the syringe body 10 , Embodiment 9 allows for a more reliable fixation of the syringe 1 and locknut 35 . Additional Particulars Regarding Embodiments 6 Through 9 [0161] Although the prefilled syringe 1 of the present invention has been explained with an example in which the needle hub 60 is attached after the locknut 30 being detached, the present invention is not limited to that case. Instead of a needle hub, a tubelike luer or a tube may be used. It is effective to attach, from the top, a cap or the like to the prefilled syringe 1 with a needle hub attached thereto so as to protectively cover the needle hub and needle tube for the purpose of avoiding accidental pricking. As such a cap, one similar to a cap for a vial container can be used. [0162] Each embodiment described above discloses a structural example of a locknut having a female screw formed therein. However, the present invention is not confined to this structure, and the prefilled syringe 1 may be appropriately connected to the port of a line system using a discontinuous thread, a cup joint, or another structure. [0163] In addition, although each embodiment above describes a structural example of a locknut having two arms, the present invention is not limited to the number of arms. Further more, instead of the arms, a tubular extension may be formed by extending the cylindrical body of the locknut in the axial direction, and projections may be provided on the inner side of the extension. In this case, it is desirable that the locknut and syringe be engaged with each other by not fitting engagement, but screwing engagement in view of the elastic deformation properties of the locknut. [0164] The luer part of the syringe used in the present invention does not necessarily have a circular cross section, and may have a rectangular, elliptic or triangle cross section, for example. Note however that, in this case, a port and a needle hub matching the shape of the luer part have to be employed. [0165] In addition, the present invention may have a structure in which multiple arms are provided that extend from the outer circumference of the top face portion positioned at the base of the luer part, and are engaged with the convex portion formed on the outer surface of the locknut. In this case, the structure is designed so that each arm is detached from the locknut by applying external forces to the syringe body in a direction different from the axial direction. 10. Embodiment 10 10-1. Overall Structure of Prefilled Syringe [0166] FIG. 19 is a cross sectional diagram showing structures of a prefilled syringe and a connector (locknut) according to Embodiment 10. For convenience of explanation, the plunger 40 is shown here in normal lateral view rather than in cross section. [0167] The prefilled syringe 1 shown in FIG. 19 may comprise the syringe body 10 , the plunger (also referred to as a piston) 40 and the like. [0168] The syringe body 10 may be a tubular body formed by injection molding a material with high chemical resistance, such as polyethylene, polypropylene, polycarbonate or polyvinyl chloride. The tip end of the syringe body 10 is sealed by the top face portion 110 , and the luer part 120 juts out from the center of the top face portion 110 . [0169] On the other hand, the opening 12 is formed at the posterior end of the syringe body 10 . Although the luer part 120 is formed by drawing to basically give a tapered shape, the stepped portion 123 is provided in a part of the tapered shape, which thereby forms the luer base portion 121 having a smaller diameter and the luer tip portion 122 located on the tip side of the luer part 120 and having a larger diameter. A fixture 20 , to be hereinafter described, is fitted to the stepped portion 123 . In addition, the luer tip portion 122 is formed in a tapered shape in compliance with ISO6/100 so that the regular needle hub 20 can be attached thereto easily. In FIG. 19 , the cap 15 is attached to the tip of the luer part 120 . [0170] In the following description, the longitudinal direction of the syringe body 10 is referred to as an “axial direction” while a direction perpendicular to the axial direction is referred to as a “radial direction”. [0171] The plunger 40 is made of a resin material with high chemical resistance, similarly to the syringe body 10 , and includes the plunger body 42 having a cruciform cross sectional shape for the purpose of reinforcement, at each end of which are formed disk-shaped end pieces having main surfaces in the radial direction. One of the end pieces is the pressing end portion 41 to be pressed by the user with a thumb, and the other end piece is the head portion 43 that is inserted inside the syringe body 10 in the axial direction. [0172] The packing 44 is provided at the tip of the head portion 43 in a manner to make tight contact with the internal wall of the syringe body 10 . Here, medication 100 is held in the syringe body 10 , which is internally sealed by the packing 44 and the cap 20 . [0173] When using the prefilled syringe 1 having such a structure, the user removes the cap 20 to enable discharge of the medication 100 . As the user pushes the pressing end portion of the plunger 40 into the syringe body 10 with a thumb, the medication 100 is discharged from the tip of the luer part 120 according to the depressed amount of the plunger. 10-2. Structures of Fixture and Locknut [0174] The prefilled syringe 1 of Embodiment 10 is constructed such that the locknut 30 , which is a connector easily detachable from the syringe body 10 , is inserted onto the luer part 120 in the axial direction and attached thereto so as to be engaged with the fixture 20 positioned at the stepped portion 123 . The locknut 30 is used in the medical field as a connection implement for connecting the prefilled syringe 10 to a fixed connection port of a transfusion line system or blood collection line system. Note that, here, the prefilled syringe 1 is adopted as a syringe for engaging with the locknut 30 ; however, the present invention may be applied to syringes other than prefilled syringes. [0175] The fixture 20 is formed by injection molding a resin material with mechanical strength and appropriate elasticity. As shown in the assembly drawing of FIG. 20 , the fixture 20 comprises: a platy fixture body 201 having an insertion hole 202 ; two platy arms 205 and 206 extending in one direction from the periphery of the fixture body 201 ; and two platy levers 203 and 204 also extending in the opposite direction from the periphery of the fixture body 201 . [0176] The diameter of the insertion hole 202 of the fixture body 201 is slightly smaller than that of the luer tip portion 122 of the luer part 120 , but larger than that of the luer base portion 121 . The fixture 20 is inserted onto the luer part 120 through the insertion hole 202 and then forcedly shifted to fit at the luer base portion, and whereby the stepped portion 123 abuts on the periphery of the insertion hole 202 and the fixture 20 is held so as to be not easily separated from the luer part 120 . In order to favorably hold the fixture body 201 by “forced fit” at the stepped portion 123 using the insertion hole 202 , it is desirable to make the insertion hole 202 have the minimum possible diameter that enables the luer base portion 121 to pass therethrough. In addition, the diameter enabling the “forced fit” varies according to the elasticity of the material of the fixture body 201 , and therefore it is desirable to take into account the size of the luer base portion 121 and the material properties of the fixture 20 for designing the insertion hole 202 . [0177] The two arms 205 and 206 extend in the syringe axial direction, and projections 2050 and 2060 , each having a triangular cross section, are formed inside the tip ends of the arms 205 and 206 . Note that the cross-sectional shape of the projections 2050 and 2060 may be rectangular, semicircular, or other forms. [0178] The two levers 203 and 204 and the arms 205 and 206 are formed swayable so that each of these sets warps away from the syringe axis, with portions thereof adjacent to the fixture body 201 being fixed points and their tip ends spreading like open tweezers. As shown in FIG. 20 , the levers 203 and 204 are formed to be symmetric with the two arms 205 and 206 , respectively, around the fixed points of the fixture 201 , and thereby when the levers 203 and 204 are pressed, the arms 205 and 206 open up, warping away from the syringe axis. This mechanism is for detaching the locknut 30 . Note that it is desirable to use a material having appropriate elasticity (polypropylene, for example) for the fixture 20 in order to favorably design the insertion hole 202 and achieve the swayable mechanism. [0179] The locknut 30 has a cylindrical shape having a bottom, and is formed by injection molding a resin material with high mechanical strength. A screw thread is cut on the internal surface of the lateral side portion (outer surface) 301 , which corresponds to the cylindrical part of the locknut 30 , to thereby form the female screw 3010 in compliance with, for example, ISO594-2. The female screw 3010 engages with the male screw to be hereinafter described. [0180] An insertion hole 305 is provided on the main surface portion 302 that is the bottom of the locknut 30 . The insertion hole 305 is formed to have a diameter at least larger than that of the luer tip portion 122 so that the entire luer part 120 of the prefilled syringe 1 is inserted thereto with clearance therebetween. Concave portions 303 and 304 are formed on the lateral side portion 301 of the locknut. These concave portions 303 and 304 have, for example, a rectangular cross section, and their locations and sizes are determined so that the concave portions 303 and 304 can engage with the projections 2050 and 2060 provided on the arms 205 and 206 of the fixture 20 . 10-3. Engagement of Syringe and Locknut [0181] As a characteristic of Embodiment 10, the engagement of the syringe body 10 and locknut 30 using the fixture 20 is described with reference to the assembly drawing of FIG. 20 . Note that FIG. 20 shows an operation of attaching the fixture 20 to the luer part 120 , and this operation takes place only when the fixture 20 is attached to the syringe body 10 for the first time. Once the luer part 120 and fixture 20 are attached to each other, the present invention does not require to detach them again. [0182] As to the locknut 30 having the above structure and the fixture 20 fitted with the luer base portion 121 of the luer part 120 and held at the stepped portion 123 , the user first presses the levers 203 and 204 by gripping them with fingers so as to open the tip ends of the arms 205 and 206 away from the axial direction, as shown in FIG. 22 . While this state is maintained, the user inserts, into the insertion hole 305 along the axial direction, the luer tip portion 122 of the luer part 120 to which the fixture 20 is attached. At this point, since the insertion hole 305 has a sufficiently large diameter as compared to the luer tip portion 122 of the luer part 120 , the user can smoothly insert the luer part 120 into the locknut 30 . Note that the size of the insertion hole 305 may be set so that the insertion hole 305 is slidable over the luer tip portion 122 to some degree, and then a device preventing the locknut 30 from easily disengaging from the luer tip portion 122 may be provided. [0183] After shifting the locknut 30 sufficiently to the luer part 120 side, as the second step, the user checks on the relative positions of the concave portions 303 and 304 provided on the locknut's lateral side portion 301 and the projections 2050 and 2060 of the fixture 20 , and releases the pressure applied on the levers 203 and 204 . Herewith, the projections 2050 and 2060 of the arms 205 and 206 engage with the concave portions 303 and 304 of the locknut 30 , and whereby the locknut 30 is favorably held on the syringe body 10 by means of the fixture 20 . [0184] On the other hand, the fixture 20 and locknut 30 can, after being engaged with each other, be again detached by performing a predetermined operation (i.e. applying an external force on the fixture 20 in a direction different from the syringe axial direction) in the following manner. That is, when the user presses the levers 203 and 204 while grasping the fixture 20 , the projections 2050 and 2060 of the arms 205 and 206 are released from the concave portions 303 and 304 of the locknut 30 according to so-called “the principle of leverage”, and in this state of things, the user can pull the locknut 30 out along the axial direction. This operation can be performed in a reversible and simple fashion (for example, in one hand), and the user is therefore able to easily attach the locknut 30 to the prefilled syringe 1 when required, and detach the locknut 30 , when not required, to thereby use the prefilled syringe 1 alone. [0185] FIG. 21 is a cross sectional view showing that the prefilled syringe 1 may be connected, using the locknut 30 , to the fixed connection port 50 of a transfusion line system. The male screw of the port 50 is screwed into the female screw 3010 of the locknut 30 shown in FIG. 21 , and herewith the luer tip portion 122 of the luer part 120 of the prefilled syringe 1 is in close contact with the packing 52 provided inside the port 50 and is inserted into the transfusion line. The locknut 30 is tightly engaged with the syringe 1 by the projections 2050 and 2060 of the arms 205 and 206 and the concave portions 303 and 304 of the locknut 30 so that the prefilled syringe 1 does not come apart from the port 50 along the axial direction even if some degree of tension is applied to the prefilled syringe 1 . As a result, the user is able to leave the prefilled syringe 1 connected to the port 50 over a long period of time and deliver a required amount of medication 100 to the inside of the port 50 by safely pushing the plunger 40 into the syringe body 10 . [0186] On the other hand, FIG. 23 is a cross sectional view showing that the prefilled syringe 1 is connected to the direct connection port 500 of a transfusion line system after the locknut 30 has been detached from the prefilled syringe 1 . With the prefilled syringe 1 from which the locknut 30 has been detached, no obstacle exists around the luer tip portion. It is therefore possible to, without the interference of the locknut 30 , achieve a suitable connection between the prefilled syringe 1 and the port 500 by properly and tightly holding the luer tip portion 122 with the packing 52 in the port 500 . As a result, with the direct connection port 500 also, the user is able to leave the prefilled syringe 1 connected to the port 500 over a long period of time and deliver a required amount of medication 100 to the inside of the port 50 by safely pushing the plunger 40 into the syringe body 10 . [0187] FIG. 24 is a cross sectional view showing that the needle hub 60 is attached to the luer tip portion 122 after the locknut 30 has been detached from the prefilled syringe 1 . The needle hub 60 has a structure in which the socket portion 61 composed of a resin material and formed to match the shape of the luer tip portion 122 holds the needle tube 62 which is an injection needle. With the conventional prefilled syringe in which the locknut is fixed and cannot be detached therefrom as shown in FIG. 43 , the locknut obstructs the view of the user and makes it difficult to visually determine the positioning of the luer and the needle hub, thereby creating the danger of the user mistakenly pricking himself/herself and coming into contact with infectious material. However, Embodiment 1 solves such a conventional problem since allowing for easy observation of the positional relationship around the luer between the levers 205 and 206 which spread like open tweezers from the fixture 20 . Other Embodiments [0188] Note that although in Embodiment 10 the locknut 30 is attached to the syringe using the arms 205 and 206 and concave portions 303 and 304 , the following embodiments are also within the scope of the present invention. 11. Embodiment 11 [0189] In a structural example of Embodiment 11 shown in FIG. 25 , slit-shaped concave portions 303 E and 304 E are formed on a lateral side portion 301 E of a locknut 30 E along the circumference thereof. On the other hand, in addition to levers 203 A and 204 A similar to the levers 203 and 204 of Embodiment 10, arms 205 A and 206 A are provided, each shaped like an arc of a semicircle in cross section. These arms 205 A and 206 A extend from a fixture body 20 A, and a slit 207 A is created on the arms 205 A and 206 A adjacent to the boundary between the arms 205 A and 206 A and the fixture body 201 A. With the slit 207 A, the arms 205 A and 206 A spread like open tweezers when the user presses the levers 203 A and 204 A. On the inner side of the tip ends of the arms 205 A and 206 A, projections 2050 A and 2060 A are formed to match the shape of the slit-shaped concave portions 303 E and 304 E. [0190] Embodiment 11 with the fixture 20 and locknut 30 having such structures can achieve an equivalent effect to that of Embodiment 10. In addition, Embodiment 11 has a structure in which the arms 205 A and 206 A hold the locknut 30 E in a manner to encase it, enabling more reliably attachment of the locknut 30 E to the syringe 1 without any play. Furthermore, according to Embodiment 11, even if torque is applied to the locknut 30 E in the radial direction while in use, the engagement of the slit-shaped concave portions 303 E and 304 E and the projections 2050 A and 2060 A favorably prevents the locknut 30 A from rotating, which results in maintaining stable engagement of the syringe 1 and locknut 30 E. 12. Embodiment 12 [0191] In a structural example of Embodiment 12 shown in FIG. 26 , a female screw portion 303 B is spirally formed on a lateral side portion 301 B of the locknut 30 B along the circumference thereof. On the other hand, in addition to levers 203 B and 204 B similar to the levers 203 and 204 of Embodiment 10, arms 205 B and 206 B having male screw portions 2050 B and 2060 B made up of multiple projections are provided. The female screw portion 303 B and male screw portions 2050 B and 2060 B are formed so that they can be screwed with each other. The arms 205 B and 206 B are provided so as to extend from a fixture body 201 B, and spread like open tweezers when the user presses levers 203 B and 204 B. To attach a fixture 20 B to the locknut 30 B, the user spreads the male screw portions 2050 B and 2060 B by pressing the levers 203 B and 204 B, and brings the male screw portions 2050 B and 2060 B into contact with the female screw portion 303 B provided on the external peripheral surface of the locknut 30 B. Subsequently, the male screw portions 2050 B and 2060 B and the female screw portion 303 B are screwed with each other by causing relative rotation between the fixture 20 B and locknut 30 B. [0192] Embodiment 12 with the fixture 20 B and locknut 30 B having such structures can achieve an equivalent effect to that of Embodiment 10. In addition, according to Embodiment 12, it is possible to securely attach the locknut 30 B to the syringe 1 while preventing play and unwanted rotation between the fixture 20 B and locknut 30 B by adjusting the degree of screwing of the male screw portions 2050 B and 2060 B into the female screw portion 303 B (i.e. how tightly they are locked together). As a result, even if unwanted torque is applied to the locknut 30 B in the radial direction while in use, the engagement of the screw portions favorably prevents the locknut 30 B from rotating, which results in maintaining stable engagement of the syringe 1 and locknut 30 B. Additional Particulars Regarding Embodiments 10 Through 12 [0193] Although the prefilled syringe 1 of the above embodiments has been explained with an example in which the needle hub 60 is attached after the locknut 30 being detached, the present invention is not limited to that case. Instead of a needle hub, a tubelike luer or a tube may be used. It is effective to attach, from the top, a cap or the like to the prefilled syringe 1 with a needle hub attached thereto so as to protectively cover the needle hub and needle tube for the purpose of avoiding accidental pricking. As such a cap, one similar to a cap for a vial container can be used. [0194] The luer part of the syringe used in the present invention does not necessarily have a circular cross section, and either one of the luer tip portion and the luer base portion or both have rectangular, elliptic, or triangle cross sections. In brief, the luer tip portion must have a larger diameter than the luer base portion. 13. Embodiment 13 13-1. Structure of Connecter 1 J [0195] The following describes a structure of a connecter 1 J which is a connector of Embodiment 13, with reference to FIG. 27 . [0196] The connector 1 J is used to fixedly hold a syringe 5 J, to be hereinafter described, on a port 61 J (see FIG. 29 ). As shown in FIG. 27A , the connector 1 J is made up of: a connector body 10 J as the main body thereof; and a locknut 20 J functioning as a constraint portion which constrains the shape of the connector body 10 J. FIG. 27A shows that, in the connecter 1 J, the connector body 10 J is free from the construction of the locknut 20 J. [0197] Of the components of the connector 1 J, the connector body 10 J is substantially tubular with a bottom, and includes a port connecting portion 11 J and a syringe connecting portion 12 J which are integrally formed. The port connecting portion 11 J is located on the opening side of the substantially tubular connector body 10 J, and a male screw 11 a for connecting with an instrument is formed on the internal surface of the tubular body. In addition, knurling with straight ridges and grooves is provided on the outer surface of the tubular body so as to prevent slippage in an operation of connecting the connector 1 J to an instrument. [0198] The syringe connecting portion 12 J is positioned, within the connector body 10 J, at the bottom face thereof and part of the lateral wall adjacent to the bottom face. The bottom-face part of the syringe connecting portion 12 J is divided by a slit 13 J into two, up and down halves—an upper bottom member 121 J and a lower bottom member 122 J—in the y direction in the figure. The halved bottom members 121 J and 122 J are structured so that the slit 13 J therebetween is opened and closed according to the constraint force exerted by the locknut 20 J onto the connector body 10 J. A single female screw 12 a discontinued by the slit 13 J is formed on the outer surface of the syringe connecting portion 12 J. [0199] As shown in FIG. 27B , the upper and lower bottom members 121 J and 122 J divided by the slit 13 J into up and down halves in the y direction respectively have a petal-like shape, and swing in the y direction in the figure when no constraint force is exerted by the locknut 20 J. Formed on the respective bottom members 121 J and 122 J are semicircular cutouts 121 h and 122 h . The chords of the cutouts 121 h and 122 h correspond to the lines extending from the edges of the bottom members 121 J and 122 J exposed to the slit 13 J. In the state shown in FIG. 27B , the cutouts 121 h and 122 h oppose each other across a space, forming an oval shape. Here, a hypothetical inscribed circle 12 h of the cutouts 121 h and 122 h has a diameter of φD 0 . [0200] Referring back to FIG. 27A , the locknut 20 J is placed to encircle the periphery of the syringe connecting portion 12 J in the connector body 10 J, and a male screw 21 J is provided on the internal peripheral surface as shown in the closeup in the figure. The male screw 21 J is to be screwed with the female screw 12 a formed on the outer surface of the syringe connecting portion 12 J in the connector body 10 J. In addition, on the outer peripheral surface of the locknut 20 J, knurling, similar to the one provided on the outer surface of the port connecting portion 11 , is performed on the outer peripheral surface of the locknut 20 J to thereby prevent slippage. When the locknut 20 J is positioned, in the x direction, to the right of the syringe connecting portion 12 J as shown in FIG. 27 , the syringe connecting portion 12 J spreads like open tweezers toward the bottom side. Herewith, the cutouts 121 h and 122 h form an oval shape as described above. 13-2. State-Changeable Mechanism of Connector 1 J [0201] The following describes a state-changeable mechanism of the connector 1 J having the above-mentioned structure. [0202] In FIG. 27A , the locknut 20 J is located, in the x direction, on the rightmost side of the syringe connecting portion 12 J in the connector body 10 J. In this configuration, the locknut 20 J does not apply constraint force to the syringe connecting portion 12 J. [0203] When the locknut 20 J in the configuration shown in FIG. 27A is shifted, in the x direction, to the left of the syringe connecting portion 12 J as being screwed into the female screw 12 a , the syringe connecting portion 12 J becomes subject to constraint force exerted by the locknut 20 J in the direction that the slit 13 J becomes narrowed—i.e. in the direction that the space between the petal shaped bottom members 121 J and 122 J becomes narrowed. When the locknut 20 J has been shifted to the vicinity of the bottom, the shape of the syringe connecting portion 12 J that previously spread like open tweezers has been transformed to be substantially tubular. With the transformation, the space between the cutouts 121 h and 122 h narrows, and the diameter of the inscribed circle 12 h is also reduced to less than the diameter φD 0 . [0204] It is preferable that the connector body 10 J be made of a material having elastic properties (e.g. a resin material) in consideration for repetitive attachment and detachment. Although the syringe connecting portion 12 J changes its shape under the constraint force of the locknut 20 J, the transformation is performed within the elastic range of the material constituting the connector body 10 J. Accordingly, the syringe connection portion 12 J returns to the state shown in FIGS. 27A and 27B without any deformation once the constraint force of the locknut 20 J is removed. [0205] Thus, the connector 1 J has a mechanism that the space between the cutouts 121 h and 122 h on the bottom members 121 J and 122 J widens and narrows simply by tightening and loosening the locknut 20 J. This mechanism is reversible and can be operated repeatedly. [0206] The general structure of a syringe 5 J is described with reference to FIG. 28 . [0207] The syringe 5 J, part of which is shown in FIG. 28A , is a prefilled syringe, and a luer part 51 J juts or extends out at the right-hand end of a syringe body 52 J. Formed on the base side of the luer part 51 J is a neck portion 53 J having a reduced diameter. Although no illustration is given, the syringe 5 J includes a plunger, a packing and the like, and the tubular part of the syringe body 52 J is filled with the liquid medication. [0208] Among the components of the syringe 5 J, the luer part 51 J has a tapered shape and a maximum outer diameter of φD 1 . The outer diameter φD 1 is smaller than the diameter D 0 of the inscribed circle 12 h of the connector 1 J in the open state shown in FIG. 27 , i.e. (φD 1 <φD 0 ). The neck portion 53 J on the base side of the luer part 51 J is tubular with a diameter smaller than the diameter φD 1 . [0209] A step is made in a part of the luer part 51 J close to the neck portion 53 J so as to form an engaging portion 51 a. [0210] The connection of the above-mentioned syringe 5 J and connector 1 J are described next also with reference to FIG. 28 . [0211] As shown in FIG. 28A , the locknut 20 J of the connector 1 J is set back, within the syringe connecting portion 12 J, to the side closest to the port connecting portion 11 J, and whereby the connector body 10 J is kept free from the constraint force of the locknut 20 J in the radial direction, similar to the case of FIG. 27 . The luer part 51 J of the syringe 5 J is inserted toward the inscribed circle 12 h (not shown in FIG. 28 ) of the cutouts 121 h and 122 h of the connector 1 J in this state (arrow B). Here, the maximum outer diameter D 1 of the luer part 51 J and the diameter φD 0 of the inscribed circle 12 h satisfy φD 1 <φD 0 , which thereby allows for smooth insertion of the luer part 51 J. [0212] The insertion of the luer part 51 J into the connector 1 J is done when the neck portion 53 J reaches an inner bottom surface 123 J of the connector 1 J. While the center of the syringe 5 J in the radial direction is substantially aligned with that of the connector 1 J, the locknut 20 J of the connector 1 J is rotated along the female screw 12 a and shifted to the left in the figure. The shifting is done when the locknut 20 J substantially reaches the left end of the connector body 10 J. [0213] The female screw 12 a on the outer surface of the syringe connection portion 12 J is formed up to the bottom members 121 J and 122 J (see FIG. 1 ) so that the locknut 20 J stops thereat. [0214] As shown in FIG. 28B , in a condition where the locknut 20 J has been shifted to the leftmost side of the syringe connection portion 12 J, the syringe connection portion 12 J that previously spread like open tweezers as in FIG. 28A closes under the constraint force exerted by the locknut 20 J to be substantially tubular. With the transformation, the space between the cutouts 121 h and 122 h narrows, and the diameter of the inscribed circle 12 h is also reduced. Then, the inscribed circle 12 h formed by the cutouts 121 h and 122 h becomes substantially circular in the state of FIG. 28B . At this point, the diameter of the inscribed circle 12 h of the connector 1 is φD 2 . The relationship between the diameters φD 1 and φD 2 is φD 2 <φD 1 . Namely, in the state of FIG. 28B , the inner bottom surface 123 J of the connector 1 J is engaged with the engaging portion 51 a of the syringe 5 J, and the syringe 5 J is fixedly held by the connector 1 J. [0215] Note that, in FIG. 28B , the diameter φD 2 of the open hole formed by the cutouts 121 h and 122 h in the connector 1 J is slightly larger than the outer diameter of the neck portion 53 J of the syringe 5 J so as to have a clearance therebetween. However, this clearance is not necessarily provided. [0216] As has been described, the connector 1 J is structured to be freely attachable to and detachable from the syringe 5 J by simply handling the locknut 20 J. Here, the connector 1 J may be provided to the user as an accessory of the syringe 5 J, or separately by itself. [0217] In order to change a state of the syringe 5 J from one in which the connector 1 J is attached, as shown in FIG. 28B , to one in which the connector 1 J is detached, as shown in FIG. 28A , a reverse process of the above-mentioned procedure for connecting the connector 1 J may be performed. [0218] Referring to FIG. 29 , the following describes a method of connecting the syringe 5 J, to which the connector 1 J is attached, to a port of a medical instrument in the luer-lock style. In FIG. 29 , an extension tube 6 J with a port attached thereto is used as an example of a connection target to which the syringe 5 J is connected in the luer-lock style. [0219] The extension tube 6 J of the connection target includes the port 61 J provided at one end of a tube 62 J, as shown in FIG. 29 . Within the port 61 J, a female screw 61 a is formed on the outer surface of the tubular body. The female screw 61 a corresponds to the male screw 11 a (not shown in FIG. 29 ; refer to FIGS. 27 and 28 ) of the connector 1 J (i.e. the male screw 11 a can be screwed into the female screw 61 a ). [0220] On the end face of the port 61 J, a hole 63 J is provided in the central region. This hole 63 J is connected to the inner duct of the tube 62 J. The inner diameter of the hole 63 J is set slightly smaller than the maximum outer diameter φD 1 of the luer part 51 J of the syringe 5 J, and a portion of the luer part 51 J of the syringe 5 J can enter the inner duct through the hole 63 J when the syringe 5 J is connected to the extension tube 6 J. [0221] For connecting the syringe 5 J and the extension tube 6 J to each other, the user brings the connector 1 J attached to the proximity of the luer part 51 J of the syringe 5 J (see FIG. 28 ) forward (arrow E) with respect to the extension tube 6 J, and when the connector 1 J and the port 61 of the extension tube 6 J make contacts, the user starts rotating the connector 1 J in the direction of arrow C. Herewith, the male screw 11 a provided in the connector body 10 J (see FIGS. 27 and 28 ) is progressively screwed into the female screw 61 a on the port 61 J of the extension tube 6 J. At this point, the luer part 51 J of the syringe 5 J is being inserted into the hole 63 J of the extension tube 6 J. The male screw 11 a is continuously screwed into the female screw 61 a until the space between the external peripheral surface of the luer part 51 J and the periphery of the hole 63 J is closed. [0222] In the above manner, the luer-lock connection of the syringe 5 J and extension tube 6 J is completed. Since the connection in the luer-lock style is stable, the syringe 5 J and the extension tube 6 J are less likely to come disengaged or loose from each other over a long period of time. [0223] Referring to FIG. 30 , the following describes a method of connecting the syringe 5 J to a port of a medical instrument in the luer-slip style. In FIG. 30 , a coinfusion port 7 J and an injection needle 8 J are used as examples of connection targets to which the syringe 5 J is connected. [0224] For the connection in the luer-slip style, the syringe 5 J to which the connector 1 J is not attached is used, as shown in FIG. 30 . As to the syringe 5 J, the user may use one to which no connector is originally attached, or alternatively obtain one with the connector 1 J attached thereto and use this syringe after detaching the connector 1 J therefrom. The connector 1 J can be readily detached according to a reverse process of the above-mentioned procedure shown in FIG. 28 . [0225] For the connection in the luer-slip style, the luer part 51 J of the syringe 5 J is simply inserted into a port of a connection-target medical instrument. For example, the connection of the syringe 5 J to the coinfusion port 7 J is completed simply by inserting the luer part 51 J of the syringe 5 J into a valve plug (not shown) provided in a cover body 71 J. Herewith, the interior of the syringe 5 J and the interior of the tubes 72 J and 73 J of the coinfusion port 7 J are communicated to each other. [0226] The valve plug of the coinfusion port 7 J is an elastic thin film, and a slit to receive the luer part 51 J is formed in a part of the valve plug. Since such matters are public knowledge, the descriptions are omitted here. [0227] Next, for connecting the syringe 5 J and the injection needle 8 J to each other, a needle hub 82 J of the injection needle 8 J is mounted on the luer part 51 J of the syringe 5 J. The syringe 5 J and the injection needle 8 J are connected to each other when an internal peripheral surface 82 f of the needle hub 82 J becomes tightly attached to the external peripheral surface 51 f of the luer part 51 J. Although no graphic representation is given, the needle tube 81 J juts out also inside the needle hub 82 J, and the jutted part is inserted into an inner hole of the luer part 51 J when the syringe 5 J and the injection needle 8 J are connected to each other. The needle hub 82 J and the inner hole of the luer part 51 J are tightly fitted to each other while the injection needle 8 J being connected to the syringe 5 J. That is, the needle hub 81 J and the inner hole are designed so that the liquid medication will not leak out therefrom or bacteria will not enter therefrom. [0228] The luer-slip connection of the syringe 5 J and another medical instrument has been described by presenting two examples above. The syringe 5 J of FIG. 30 does not have the connector 1 J attached thereto, allowing for quick luer-slip connection. [0229] Although, there are various medical instruments that can be connected to the syringe 5 J in the luer-slip style besides the above two examples, the connection operations for those instruments are the same as above. [0230] Advantages of Connector 1 J and Syringe 5 J Having Connector 1 J Attached Thereto [0231] As has been described above and also shown in FIG. 28 , the connector 1 J of Embodiment 13 is attachable to and detachable from the syringe 5 J by simply performing the screwing operation of the locknut 20 J. [0232] Thus, in the medical practices, the user is able to readily attach and detach the connector 1 J to/from the syringe 5 J according to need. [0233] Thus, since being able to attach and detach the connector 1 J functioning as a connector to/from the syringe 5 J if necessary, the user can use the detached connector 1 J with another syringe. This results in a reduction in the cost burden on the user and allows for an excellent operational performance of the syringe 5 . Furthermore, the syringe 5 J can be connected to the port of another medical instrument in either the luer-slip or luer-lock style. [0234] When connecting the injection needle 8 J to the syringe 5 J, the user can use the syringe 5 J from which the connector 1 J has been detached, as shown in FIG. 30 . Thus, the syringe 5 J is also effective in preventing the user from mistakenly pricking himself/herself. [0235] Note that the connector 1 J, which functions as a connector, does not have to be provided with every syringe 5 J when supplied to the user, and may be singularly provided to the user instead. In such a case, the user may attach/detach the connector 1 J to/from the syringe 5 J according to need. Thus, the connector 1 J can be attached and detached, according to the connection style of the syringe 5 J with the port, at the stages of treatment and medical care in the medical practices. As a result, operating efficiency can be improved, and the number of syringe types required to be prepared in advance can be reduced. [0236] Additional Particulars Regarding Embodiment 13 [0237] Although Embodiment 13 is described with an example in which the connector body 10 J is fitted to the extension tube 6 J by screwing the locknut 20 J into the connector body 10 J and thereby making the locknut 20 J shift toward the connector body 10 J, the present invention is not limited to the case. The same effect as that of Embodiment 13 can be achieved, for example, with a connector having, instead of the locknut 20 J, a ring body with no screw provided on the internal peripheral surface thereof. Here, the connector body 10 J is fitted to the extension tube 6 J by sliding the ring body toward the connector body 10 J. [0238] Note that, in the case of adopting such a sliding mechanism, it is required to implement a measure that prevents the ring body from shifting back to the original position when the connector body 10 J is fitted to the extension tube 6 J. Fixing the ring body with a pin is an example of such a measure. [0239] Although, in the above embodiment, the connection target is the (prefilled) syringe 5 J filled with liquid medication in advance, the above operation remains the same even if a different type of syringe, other than a prefilled syringe, is used. 14. Embodiment 14 [0240] The structure of a connector 1 K of Embodiment 14 which functions as a connector is described with the aid of FIG. 31 . [0241] As shown in FIG. 31A , the connector 1 K may be made up of three components: split frames 11 K and 12 K; and a coupling portion 13 K coupling the sides of the split frames 11 K and 12 K. These three components are integrally formed. Of them, the split frames 11 K and 12 K have a shape as if created by halving, along the axis, a hollow cylinder having a bottom. FIGS. 31A and 31B show the state where the split frames 11 K and 12 K are open (hereinafter, “the open position”). [0242] Each of the split frames 11 K and 12 K having a shape as if created by halving a cylinder hollow having a bottom includes a semicylindrical portion 112 K/ 122 K and a semicircular bottom portion 11 K/ 121 K. Formed on the semicylindrical portions 112 K and 122 K are sets of tabs 11 m and 12 m to be interlocked with each other. That is, the tabs 11 m and 12 m function as coupling members of the split frames 11 K and 12 K, and become interlocked with each other when the split frames 11 K and 12 K are coupled. These tabs 11 m and 12 m are designed so that, when once they are interlocked with each other, the coupling will not be disconnected unless an operation of pulling the tabs 12 m outward is performed. Cutouts 11 h and 12 h are formed on the bottom portions 111 K and 112 K that butt against each other when the split frames 11 K and 12 K are engaged using the tabs 11 m and 12 m (hereinafter, “the closed position”). Each of the cutouts 11 h and 12 h has the shape of a semicircle with a chord coinciding with the halving line of the split frames 11 K and 12 K. [0243] Furthermore, male screw portions 11 n and 12 n are provided on the inner surface of the semicylindrical portions 112 K and 122 K of the split frames 11 K and 12 K. These male screw portions 11 n and 12 n form a single, unbroken male screw when the split frames 11 K and 12 K are in the closed position. [0244] The wall thickness of the coupling portion 13 K is thinner than that of the individual split frames 11 K and 12 K, and the coupling portion 13 K will not be dismembered after repetitive opening and closing of the split frames 11 K and 12 K. [0245] The opening-and-closing mechanism of the connector 1 K having the above structure is described next with the aid of FIG. 31B showing the connector 1 K of FIG. 31A viewed from arrow A. [0246] As shown in FIG. 31B , in an anterior view, each of the split frames 11 K and 12 K is semicircular. When folded at the coupling portion 13 , the split frames 11 K and 12 K face to each other, and the tabs 11 m and 12 m interlock with each other. Thus, the connector 1 K is substantially in the shape of a cylinder having a bottom when the tabs 11 m and 12 m engage with each other (i.e. in the closed position). [0247] Thus, when the split frames 11 K and 12 K are joined together, the cutouts 11 h and 12 h provided on the split frames 11 K and 12 K also face to each other to form a circular hole with a diameter of φD 1 . [0248] Note that the split frames 11 K and 12 K and the coupling portion 13 K, all of which are integrally formed, are preferably made of, for example, a resin material in order to achieve the above-mentioned functions. [0249] A general structure of a syringe 5 K is described with the aid of FIG. 32 . [0250] The syringe 5 K, a part of which is shown in FIG. 32 , is a prefilled syringe, and a luer part 51 K juts out at the right-hand end of a syringe body 52 K. Formed on the base side of the luer part 51 K is a neck portion 53 K having a reduced diameter. Although no illustration is given, the syringe 5 K includes a plunger, a packing and the like, and the tubular part of the syringe body 52 K is filled with the liquid medication. [0251] Among the components of the syringe 5 K, the luer part 51 K has a tapered shape and a maximum outer diameter of φD 3 . The outer diameter φD 3 is larger than the diameter φD 1 of the hole formed by the cutouts 11 h and 12 h in FIG. 31 (i.e. φD 3 >φD 1 ). The neck portion 53 K located on the base side of the luer part 51 K is in the shape of a cylinder with an outer diameter of φD 2 . [0252] A step is made in a part of the luer part 51 K close to the neck portion 53 K so as to form an engaging portion 51 n. [0253] The connection of the above-mentioned syringe 5 K and connector 1 K is described next with reference to FIGS. 31 and 32 . [0254] The luer part 51 K of the syringe 5 K is inserted into the connector 1 K in the open position as shown in FIG. 31A and positioned in a manner that the neck portion 53 K sets in the edge of either the cutout 11 h or 12 h . At this point, the syringe 5 K and the connector 1 K are maintained so that their axes substantially coincide with each other. [0255] Next, while the syringe 5 K is held not to move with respect to the connector 1 K, the split frames 11 K and 12 K are folded at the coupling portion 13 K so that the openings of the split frames 11 K and 12 K face to each other. The connector 1 K has the shape of a cylinder having a bottom when the tabs 11 m and 12 m of the split frames 11 K and 12 K interlock with each other. At this point, the cutouts 11 h and 12 h form a circular hole with an inner diameter of φD 1 . [0256] The syringe 5 K is thus engaged, at the neck portion 53 K, with the connector 1 K in the closed position. That is, the maximum outer diameter φD 3 of the luer part 51 K is larger than the inner diameter φD 1 of the hole formed by the cutouts 11 h and 12 h , and the engaging portion 51 n of the luer part 51 K is fixedly held by inner bottom faces 111 n and 121 n of the connector 1 K. Thus, the syringe 5 K and the connector 1 K are connected to each other. The tabs 11 m / 12 m of each set are provided at two locations on the split frame 11 K/ 12 K, and when these tabs 11 m and 12 m once interlock with each other, the connector 1 K does not return to the open position unless the disengagement operation (releasing the coupling of the tabs 11 m and 12 m ) is conducted. [0257] Note that the male screw portions 11 n and 12 n , each provided on the split frame 11 K/ 12 K of the connector 1 K, are designed to form one unbroken male screw across a line of junction 1 KL of the split frames 11 K and 12 K. [0258] Referring to FIG. 32 , the following describes a method of connecting the syringe 5 K, to which the connector 1 K is attached, to a port of another medical instrument in the luer-lock style. In FIG. 32 , an extension tube 6 K with a port attached thereto is used as an example of a connection target to which the syringe 5 K is connected. [0259] The extension tube 6 K being a connection target includes a port 61 K provided at one end of a tube 62 K, as shown in FIG. 32 . Within the port 61 K, a female screw portion 61 n is formed on the outer surface of the tubular body. The female screw portion 61 n corresponds to the male screw portions 11 n and 12 n of the connector 1 K. Although no illustration is given, a hole is provided in the central region of the end face of the port 61 K, and functions as an opening of the inner duct of the tube 62 K. [0260] The hole in the central region of the port 61 K has an inner diameter slightly smaller than the maximum outer diameter φD 3 of the luer part 51 K of the syringe 5 K. Thus, the hole of the port 61 K is designed so that the luer part 51 K of the syringe 5 K can be inserted thereinto. [0261] For connecting the syringe 5 K and the extension tube 6 K to each other, the user brings the connector 1 K attached to the syringe 5 K forward (arrow B) with respect to the port 61 K of the extension tube 6 K. When the connector 1 K and the port 61 K of the extension tube 6 K make contacts, the user starts rotating the connector 1 K in the direction of arrow C and still brings the connector 1 K forward. Herewith, the male screw portions 11 n and 12 n provided in the split frames 11 K and 12 K are progressively screwed into the female screw portion 61 n on the port 61 K of the extension tube 6 K. In parallel with the screwing operation, the luer part 51 K of the syringe 5 K is gradually inserted into the hole on the end face of the port 61 K of the extension tube 6 K. Subsequently, when the male screw portions 11 n and 12 n of the connector 1 K are completely screwed into the female screw portion 61 n of the port 61 K, the syringe 5 K and the extension tube 6 K are connected to each other. [0262] Since the connection of the syringe 5 K and the extension tube 6 K with the connector 1 K therebetween (the luer-lock connection) is stable, the syringe 5 K and the extension tube 6 K are less likely to disengage or loose from each other over a long period of time. [0263] Referring to FIG. 33 , the following describes a method of connecting the syringe 5 K and another medical instrument in the luer-slip style. In FIG. 33 , a coinfusion port 7 K and an injection needle 8 K are used as examples of connection targets to which the syringe 5 K is connected. [0264] For the connection in the luer-slip style, the syringe 5 K to which the connector 1 K is not attached is used, as shown in FIG. 33 . As to the syringe 5 K, the user may use a syringe to which no connector is originally attached, or alternatively obtain a syringe with the connector 1 K attached and use this after detaching the connector 1 K therefrom. The connector 1 K can be readily detached by releasing the coupling of the interlocking tabs 11 m and 12 m. [0265] In the connection in the luer-slip style, the luer part 51 K of the syringe 5 K is simply inserted into a port of a connection-target medical instrument. For example, the connection of the syringe 5 K to the coinfusion port 7 K is completed simply by inserting the luer part 51 K of the syringe 5 K into a valve plug (not shown) provided in a cover body 71 K. Herewith, the interior of the syringe 5 K and the interior of the tubes 72 K and 73 K of the coinfusion port 7 K are communicated to each other. [0266] The valve plug of the coinfusion port 7 K is an elastic thin film, and a slit to receive the luer part 51 K is formed in a part of the valve plug. Since such matters are public knowledge, the descriptions are omitted here. [0267] Next, for connecting the syringe 5 K and the injection needle 8 K to each other, a needle hub 82 K of the injection needle 8 K is mounted on the luer part 51 K of the syringe 5 K. The syringe 5 K and the injection needle 8 K are connected to each other when an internal peripheral surface 82 f of the needle hub 82 K becomes tightly attached to the external peripheral surface 51 f of the luer part 51 K. Although no graphic representation is given, the needle tube 81 K juts out also inside the needle hub 82 K, and the jutted part is inserted into an inner hole of the luer part 51 K when the syringe 5 K and the injection needle 8 K are connected to each other. The needle hub 82 K and the inner hole of the luer part 51 K are tightly fitted to each other while the injection needle 8 K being connected to the syringe 5 K. That is, the needle hub 81 K and the inner hole are designed so that the liquid medication will not leak out therefrom or bacteria will not enter therefrom. [0268] The luer-slip connection of the syringe 5 K and another medical instrument has been described by presenting two examples above. The syringe 5 K of FIG. 33 does not have the connector 1 K attached thereto, allowing for quick luer-slip connection. [0269] Although there are various medical instruments can be connected to the syringe 5 K in the luer-slip style besides the above two examples, the connection operations for those instruments are the same as above. [0270] Advantages of Connector 1 K and Syringe 5 K Having Connector 1 K Attached Thereto [0271] As has been described above and also shown in FIG. 31 , the connector 1 K of Embodiment 14 is composed of the split frames 11 K and 12 K and the coupling portion 13 K, and allows for easy attachment to the syringe 5 K by the coupling operation of the two split frames 11 K and 12 K as well as easy detachment from the syringe 5 K by releasing the interlocking tabs 11 m and 12 m and opening the split frames 11 K and 12 K. On the other hand, unless the interlocking tabs 11 m and 12 m are released, an incident in which the split frames 11 K and 12 K open up during the use of the syringe 5 K or the like is avoided. [0272] Thus, since the user is able to attach and detach the connector 1 K to/from the syringe 5 K as the need arises, the connector 1 K has advantageous effects of (1) reducing the cost burden on the user, (2) not causing hindrance to the work performance when the syringe 5 K is used, and (3) enabling connection of the syringe 5 K to the port of another instrument in either the luer-slip or luer-lock style. The syringe 5 K having the connector 1 K attached thereto also exhibits these advantages. [0273] When connecting the injection needle 8 K to the syringe 5 K, the user can use the syringe 5 K from which the connector 1 K has been detached, as shown in FIG. 33 . Thus, the syringe 5 K is also effective in preventing the user from mistakenly pricking himself/herself. [0274] Note that the connector 1 K does not have to be provided with every syringe 5 K when supplied to the user, and may be singularly provided to the user instead. In such a case, the user may attach/detach the connector 1 K to/from the syringe 5 K according to need. [0275] If using the syringe 5 K having the connector 1 K attached thereto for treatment and testing in the medical practices, the user is able to select whether to attach or detach the connector 1 K according to the connection style of the syringe to the port. Thus, using the syringe 5 K with the connector 1 K attached thereto achieves high efficiency in the medical practices. 15. Embodiment 15 [0276] A connector 2 of Embodiment 15 is described with the aid of FIG. 34 . [0277] The connector 2 K is composed of split frames 21 K and 22 K as shown in FIG. 34 , and differs from the connector 1 K in that these split frames 21 K and 22 K are separated from each other. That is, the connector 2 K can be said to be the connector 1 K of Embodiment 14 from which the coupling portion 13 K is removed. Note however that the connector 2 has additional tabs 11 m and 12 m formed on the split frames 21 K and 22 K at the locations corresponding to where the coupling portion 13 K is attached. [0278] Since other components of the connector 2 K are the same as those of the connector 1 K, the descriptions are omitted here. [0279] Attachment of the connector 2 K to the syringe 5 K is achieved by setting the neck portion 53 K of the syringe 5 in the cutouts 21 h and 22 h while the split frames 21 K and 22 K are separated from each other, and then interlocking the tabs 11 m of the split frame 21 K and the tabs 12 m of the split frame 22 K. Here, the relationships of the inner diameter of the hole formed by the cutouts 21 h and 22 h with the maximum outer diameter of the luer part 51 K of the syringe 5 K, and with the outer diameter of the neck portion 53 K are the same as those of connector 1 K of Embodiment 14 above. [0280] The connector 2 K is easily detached from the syringe 5 K by doing the reverse of the above procedure, i.e. releasing the interlocking tabs 11 m and 12 m . Accordingly, also when using the connector 2 K according to the present embodiment, the user is able to easily attach and detach the connector 2 K to/from the syringe 5 K as the need arises. [0281] As a result, the connector 2 K of Embodiment 15 also has advantageous effects of (1) reducing the cost burden on the user, (2) not causing hindrance to the work performance when the syringe 5 K is used, and (3) enabling connection of the syringe 5 K to the port of another instrument in either the luer-slip or luer-lock style. 16. Embodiment 16 [0282] A connector 3 K of Embodiment 16 is described next with the aid of FIG. 35 . [0283] The connector 3 K is characterized by the split balance of split frames 31 K and 32 K different from that of split frames 11 K and 12 K of the connector 1 K, as shown in FIG. 35 . That is, while the split frames 11 K and 12 K of the connector 1 K have a shape as if they were formed by halving, along the axis, a hollow cylinder with a bottom, the split frame 32 K of the connector 3 K according to the present embodiment has a shape as if it was formed by halving only the bottom face and the vicinity thereof of a hollow cylinder with a bottom. [0284] The opening and closing of the connector 3 K is basically the same as that of the connector 1 K shown in FIG. 31 . [0285] Besides the advantageous effects of the connector 1 K, the connector 3 K has an additional advantage of having a cylindrical part which exhibits higher stiffness when the connector 3 K is being screwed on another medical instrument (e.g. the extension tube 6 K of FIG. 32 ), as compared to that of the connector 1 K. That is, when a male screw 31 n of the connector 3 K is screwed into the female screw of the medical instrument to thereby join the connector 3 K with the medical instrument, the cylindrical part of the connector 3 K receives a force also in the outer radial direction. At this point, the connector 3 K whose cylindrical part is not split has an advantage in exhibiting higher stiffness in the radial direction than the connector 1 K whose cylindrical part is split. [0286] This means that the connector 3 K enables to set the syringe more firmly on the port of another medical instrument. Additional Particulars Regarding Embodiments 14 Through 16 [0287] In Embodiments 14 to 16 above, the features, functions and effects of the present invention are described by taking as examples three kinds of connectors 1 K, 2 K and 3 K, however, the present invention is not limited to those. [0288] Although, in Embodiment 14 above, a prefilled syringe filled with liquid medication in advance is used as an example of the syringe, the above-mentioned functions and effects remain the same even if a syringe of a different type is used. [0289] In Embodiments 14 to 16, the connector 1 K, 2 K or 3 K is connected to the syringe 5 K by using the neck portion 53 K formed on the base side of the luer part 51 K of the syringe 5 K. However, it is not necessary that the neck portion 53 K is formed on the base side of the luer part 51 K. For example, similar functions and effects to the above can be achieved by providing a narrowed part (which corresponds to the neck portion) on a part of the external peripheral surface of the syringe body 52 K and forming a connector to correspond to the narrowed part. 17. Embodiment 17 [0290] FIGS. 36A , 36 B, 36 C and 36 D illustrate a structure of a syringe of Embodiment 17. [0291] A syringe 100 L is a prefilled syringe filled with liquid medication 110 L in advance, and allows for speedy insertion and removal into/out of either the luer-lock coinfusion port or the luer-slip coinfusion port. [0292] Regarding the syringe 100 , as shown in FIG. 36A , a cylindrical syringe portion 120 L is filled with the liquid medication 110 L and subsequently sealed by a plunger portion 150 L, and a lock part 130 L (which is an example of a connection supporting member) is freely rotatably coupled to one end of the syringe portion 120 L by means of a coupling pin 160 L (which is an example of a pin). [0293] In the syringe part 120 L, a cylindrical luer part 140 L extends from one end (hereinafter referred to as “the first end”) of a cylindrical syringe body 121 L, and a flange 121 a is provided at the opposite end to the first end (hereinafter referred to as “the second end”). [0294] The luer part 140 L is cylindrical, and may be composed of: a 1 st luer portion 144 L with a diameter d 1 on the base side; and a tapered 2 nd luer portion 141 L located on the tip side of the luer part 140 L and having a tip-end diameter d 2 and a rear-end diameter d 3 . With this arrangement, d 3 >d 2 and d 3 >d 1 . [0295] The lock part 130 L is made of a resin material, and is a cylindrical nut with a bottom for engaging the syringe 100 L and a connection-target instrument. A through hole 134 L of a diameter d 4 is provided on the bottom face of the lock part 130 L, and through holes 132 a and 132 b with rectangular openings are provided on the lateral side of the cylindrical body. [0296] Note that d 4 is larger than d 3 to enable the 2 nd luer portion 141 L to pass through the through hole 134 L. [0297] The coupling pin 160 L is a substantially U-shaped pin for engaging the lock part 130 L and the luer part 140 L, and has a function of engaging with the 1 st luer portion 144 L while penetrating through the hull of the lock part 130 L to be thereby fitted with the lock part 130 L. [0298] To be more specific, as shown in FIG. 36D which is a cutaway view of the coupling pin 160 L fitted with the lock part 130 L and cut parallel to the main surface thereof, the coupling pin 160 L is a substantially U-shaped pin having two symmetric extending portions 163 L extending from a rectangular base portion 161 L. Stepped portions 162 L, which abut against the lock part 130 L when inserted thereinto, are provided at the base of the extending portions 163 L, and a projecting portion 163 a is provided on the outer side of each extending portion 163 L, towards the tip end thereof. [0299] Provided in the center of the groove 164 L formed between these two extending portions 163 L is a concave portion 165 L to which the 1st luer portion 144 L is fitted. [0300] There is no problem whether the lock part 130 L and coupling pin 160 L are detached or attached from/to the syringe 100 L when the syringe 100 L is delivered to a medical practice site. Here, for convenience of explanation, the syringe 100 L is used from which the lock part 130 L and coupling pin 160 L have been detached at the time of delivery. [0301] The following explains how to use the syringe 100 L. [0302] Connection with Luer-Lock Coinfusion Port [0303] When a coinfusion port to which the syringe 100 L is to be connected is a luer-lock coinfusion port, a person (hereinafter, the “operator”) inserts the luer part 140 L into the through hole 134 L of the lock part 130 L, as shown in FIG. 36A . Subsequently, the operator inserts the coupling pin 160 L into the through holes 132 a and 132 b of the lock part 130 L as shown in FIG. 36B , and pushes the coupling pin 160 L thereinto until the edges of the stepped portions 162 L of the lock part 130 L make contacts with edges 162 a of both sides of the through hole 132 a , as shown in FIGS. 37A to 37F . [0304] At this point, the projecting portions 163 a of the coupling pin 160 L go over contact points 162 b on both sides of the through hole 132 b and thereby prohibit the coupling pins 160 L from shifting in the reverse direction of the insertion. At the same time, the 1 st luer portion 144 L is fitted into the concave portion 165 L. [0305] Here, the 1st luer portion 144 L and the lock part 130 L are engaged with each other to be positioned concentrically. [0306] In addition, since the contact faces of the 1st luer portion 144 L and the concave portion 165 L of the coupling pin 160 L slip against each other in the circumferential direction, the 1st luer portion 144 L and the lock part 130 L rotate relatively to each other around the central axis of the 1st luer portion 144 L. [0307] As to the above-mentioned coinfusion port 200 L which is a luer-lock coinfusion port, on the lateral side of a port body 201 L functioning as a transfusion line or a similar flow path, a rubber valve 204 having a hole 204 a is held in place by being covered with a cylindrical cover body 202 L. A screw thread is cut on the external periphery of the cover body 202 L to thereby form a thread groove 203 L. [0308] When connecting the syringe 100 L to the coinfusion port 200 L, the operator rotates the lock part 130 L and screws the lock part 130 L onto the thread groove 203 L while inserting the 2nd luer portion 141 L of the syringe 100 L into the hole 204 a of the coinfusion port 200 L, as shown in FIG. 36C , and whereby the syringe 100 L is securely connected to the coinfusion port 200 L. [0309] When connecting the syringe 100 L to the luer-slip coinfusion port 210 L, the operator is able to rapidly connect the syringe 100 L, to which the lock part 130 L is not attached, to a coinfusion port 210 L by inserting the 2nd luer portion 141 L into the hole 204 a of the coinfusion port 210 L, as shown in FIG. 38 . [0310] Thus, since the syringe 100 L of the present embodiment allows for easy attachment and detachment of the lock part 130 L by insertion and pullout of the coupling pin 160 L, the syringe 100 L is smoothly connected to a luer-slip style instrument by detaching the lock part 130 L from the syringe 100 L, similarly to the case of a conventional luer-slip syringe. [0311] When the syringe 100 L is connected to an instrument in the luer-lock style, secure connection can be established by attaching the lock part 130 L to the syringe 100 L, similarly to the case of a conventional luer-lock syringe. [0312] In Embodiment 17, the 1 st luer portion 144 L and the lock part 130 L are designed to rotate relatively to each other, however, the present invention is not limited to this. For example, the following structure may be employed: a spline parallel to the syringe axis direction (hereinafter, “the 1 st spline) is provided on the outer surface of the 1 st luer portion 144 L of the syringe 100 L, and another spline (hereinafter, “the 2 nd spline”) corresponding to the 1 st spline is provided on the concave portion 165 L of the coupling pin 160 L. Herewith, when the 1 st luer portion 144 L is fitted into the concave portion 165 L, the 1 st and 2 nd splines are fitted with each other so that the 1 st luer portion 144 L is positionally fixed in relation to the concave portion 165 L. [0313] In this case, although the syringe 100 L and the lock part 130 L cannot rotate relative to each other, the above-mentioned nut can be screwed by rotating the entire syringe 100 L while inserting the 2 nd luer portion 141 L into a target location since the lock part 130 L and the 1 st luer portion 144 L are in a concentric configuration. [0314] Note also that, although in Embodiment 17 the lock part 130 L of the syringe 100 L is a nut that engages with an instrument such as a coinfusion port, this is merely an example and the part does not have to be a nut. [0315] For instance, as in Embodiment 18 shown in FIG. 39 , a lock part 132 L having claw portions 133 a and 133 b may be used instead of the lock part 130 L having a thread. [0316] In this case, the change in the locking mechanism of the syringe necessitates a change in the structure of the engaging portion of the luer-lock coinfusion port. A coinfusion port 220 L having two L-shaped grooves 231 a is one example of such a structural change. [0317] Note that, although the coupling pin 160 L is substantially U-shaped, this is merely an example. If a pin fulfills a similar function, i.e. enabling the lock part 130 L and the luer part 140 L to be fixed at a determined position, the pin may take any shape. [0318] For example, a coupling pin 180 of Embodiment 19 shown in FIG. 40 (corresponding to FIG. 36D ) may be used. Here, a lock part 170 L has been formed by partially revising the cross-sectional shape of the lock part 130 L so that the lock part 170 L serves the function fulfilled by one of the two extending portions 163 L of the coupling pin 160 L, and the coupling pin 180 L has only one extending portion 163 L. INDUSTRIAL APPLICABILITY [0319] The connector-attached syringes, connectors used for syringes, and syringes of the present invention can be used to apply liquid medication to patients and collect blood in medical practices. [0320] The connector-attached syringes and connectors of the present invention are adaptable for both luer-slip and luer-lock style ports, providing a cost reduction to the users. [0321] The present invention is applicable to manufacturing medical syringes used in medical practices in which various types of connection ports are used.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Ser. No. 08/189,694, filed Feb. 1, 1994, which is a continuation of International Application No. PCT/US92/06290, filed Aug. 3, 1992, which is a continuation-in-part of U.S. Ser. No. 07/739,765, filed Aug. 1, 1991, abandoned. SUMMARY OF THE INVENTION This invention pertains to a new method for killing and controlling worms (Helminths) and new compositions for killing and controlling worms in animals. The invention is more particularly directed to a new method for killing and controlling parasitic worms in animals with dioxapyrrolomycin and to new anthelmintic compositions comprising the same. Dioxapyrrolomycin has the general structural formula I. BACKGROUND OF THE INVENTION The diseases or groups of diseases described generally as helminthiasis are due to infection of the animal parasitic worms known as helminths. Helminthiasis and helminthosis are prevalent and may lead to serious economic and/or health problems in sheep, swine, cattle, goats, dogs, cats, horses, poultry and man. Among the helminths, the groups of worms known as nematodes, trematodes and cestodes cause widespread and often-times serious infections in various species of animals including man. The most common genera of nematodes, trematodes and cestodes infecting the animals referred to above are Dictyocaulus, Haemonchus, Trichostrongylus, Ostertagia, Nematodirus, Cooperia, Bunostomum, Oesophagostomum, Chabertia, Strongyloides, Trichuris, Fasciola, Dicrocoelium, Enterobius, Ascaris, Toxascaris, Toxocara, Ascaridia, Capillaria, Heterakis, Ancylostoma, Uncinaria, Onchocerca, Taenia, Moniezia, Dipylidium, Metastrongylus, Hyostrongylus, and Strongylus. Some of these genera attack primarily the intestinal tract, while others inhabit the stomach, lungs, liver and subcutaneous tissues. The parasitic infections causing helminthiasis and helminthosis lead to anemia, malnutrition, weakness, weight loss, unthriftiness, severe damage to the gastrointestinal tract wall and, if left to run their course, may result in death of the infected animals. The anthelmintic activity of dioxapyrrolomycin has not been previously reported. INFORMATION DISCLOSURE Pyrrolomycins, including dioxapyrrolomycin, pyrrolomycin C, and pyrrolomycin D, are known metabolites of Streptomyces sp. The discover of dioxapyrrolomycin was reported originally by Lederle Lab, G. T. Carter, et al., J. Antibio. 40:233 (1987), under the name LL-F42248 alpha without any chemical name. Shortly after, the name of dioxapyrrolomycin was used in a report by the Institute of Microbial Chemistry, H. Nakamara, et al. J. Antibio. 40:899 (1987). Dioxapyrrolomycin was reported to be primarily active against Gram-positive bacteria with some limited antifungal activity. The LD 50 was reported to be 13 mg/kg (po) and 125-250 mg/kg (ip) in mice, G. T. Carter, et al., J. Antibio. 40:233 (1987). The insecticidal activity of dioxapyrrolomycin is also known. ACS Meeting Abstracts 97, 98, 99 (Spring 1991). G. T. Carter et al., J. Chem. Soc., Chem. Commun., 1989, pages 1271-1273, describes the biosynthesis of dioxapyrrolomycin. N. Ezaki et al., J. Antibio., 34:1363-1365 (1981); M. Kaneda et al., J. Antibio., 34: 1366-1368 (1981); and M. Koyama et al., J. Antibio., 34:1569-1576 (1981); disclose the structures and synthesis of pyrrolomycins A and B. M. Ishizuka, T. Sawa and T. Takeuchi, J. Antibio., 37:1253-1256 (1984), discloses the immunopotentiator activity of pyrrolomycin B. K. Umezawa et al., Biochem. and Biophysic. Research Communic., 105:82-88, discloses enhancement of haemolysis and cellular arachidonic acid release by pyrrolomycins, such as pyrrolomycins A, B, C and D. N. Ezaki et al., J. Antibio., 36:1263-1267 (1983), discloses pyrrolomycins C, D and E; and M. Koyama et al., J. Antibio., 36:1483-1489 (1983), discloses their structures. U.S. Pat. No. 4,495,358 discloses antibiotic pyrrolomycin E prepared by culturing a Streptomyces sp. Pyrrolomycin A, B, C and D are also produced. Derwent Abstract, Accession Number 83-755496, discloses antibiotics pyrrolomycin F, prepared by culturing Streptomyces sp. N. Ezaki et at., J. Antibio., 36:1431-1438 (1983), discloses pyrrolomycins F1, F 2a , F 2b and F 3 , which are pyrrolomycin metabolites produced by the addition of bromide to the fermentation. European Published Application 0 080 051 discloses 1-triiodoalkyl-allyl-pyrroles and analogues thereof having antifungal and antimicrobial activity, which are especially useful as antibacterial agents. These compounds were made as a result of structural modifications of pyrrolomycin A. DETAILED DESCRIPTION OF THE INVENTION The present invention particularly provides: A method of killing or preventing the occurrence of parasitic worms in an animal hosting or susceptible to said worms comprising the administration to said animal of a therapeutic or prophylactic dosage of dioxapyrrolomycin. Dioxapyrrolomycin is particularly effective against the following parasitic worms: Dictyocaulus, Haemonchus, Trichostrongylus, Ostertagia, Nematodirus, Cooperia, Bunostomum, Oesophagostomum, Chabertia, Strongyloides, Trichuris, Fasciola, Dicrocoelium, Enterobius, Ascaris, Toxascaris, Toxocara, Ascaridia, Capillaria, Heterakis, Ancylostoma, Uncinaria, Onchocerca, Taenia, Moniezia, Dipylidium, Metastrongylus, Hyostrongylus, and Strongylus. These worms most often occur in animals, such as sheep, swine, cattle, goats, dogs, cats, horses, poultry and man. The present invention also provides: An anthelmintic composition for administration to animals which comprises an effective anthelmintic amount of dioxapyrrolomycin. Such a composition is useful in animals, such as sheep, swine, cattle, goats, dogs, cats, horses, poultry and man. Lastly, the present invention provides: In the process for producing dioxapyrrolomycin from a Streptomyces sp., the improvement which comprises: the use of a culture medium comprising from about 10 to about 30 mg of starch, from about 10 to about 30 g of Solulys, from about 2 to about 8 g of meat extract, and from about 4 to about 6 g of sodium chloride, to culture the Streptomyces sp. The preferred ingredients for the medium are the following: Difco soluble starch 20 g/l; Solulys 20 g; Beef extract 4 g; NaCl 5 g; tap water, quantity sufficient (qs) 1 liter; pH adjusted to 7.2 (KOH). This process may be further improved by the addition of the resin XAD-2 to the medium. Pharmaceutically acceptable refers to those properties and/or substances which are acceptable to the patient from a pharmacological-toxicological point of view and to the manufacturing pharmaceutical chemist from a physical-chemical point of view regarding composition, formulation, stability, patient acceptance and bioavailability. The present invention includes the anthelmintic use and anthelmintic compositions of dioxapyrrolomycin. Its structure is shown as Formula I in the Formula Chart below. Dioxapyrrolomycin is a known compound and may be prepared by the methods described in G. T. Carter, et at., J. Antibio. 40:233 (1987); H. Nakamara, et at. J. Antibio. 40:899 (1987). However, the present invention provides an improvement in the process for the preparation of dioxapyrrolomycin. In G. T. Carter, et al., J. Antibio. 40:233 (1987), the medium employed in the tank fermentation consisted of molasses 20 g/l; dextrin 10 g; soy peptone 10 g; CaCO 3 1 g; pH adjusted to 7.2 (KOH). The medium of the present invention employs CBS-10 which preferably comprises Difco soluble starch 20 g/l; Solulys 20 g; Beef extract 4 g; NaCl 5 g; tap water, quantity sufficient (qs) 1 l; pH adjusted to 7.2 (KOH). These ingredients are commercially available. The amounts of ingredients are approximate and may be varied as appropriate by one of ordinary skill in the art. Corn steep liquor or spray dried lard water may be used in place of Solulys. The use of this medium more than doubled the yield of dioxapyrrolomycin. The use of this medium plus the resin XAD-2, which is commercially available, not only doubled the yield of dioxapyrrolomycin, but also produced twice as pure compound, as did the medium alone. Other such neutral resins may be used, but XAD-2 is preferred. Thus, in producing dioxapyrrolomycin for the present invention, the use of a neutral resin (XAD-2) as a titer enhancer was successfully employed. It was found that the addition of 50 g/L of XAD-2 in tank fermentations, more than doubled the amount of crude fermentation products that are extractable than when literature procedures alone are used. This increased product yield increases the amount of recoverable dioxapyrrolomycin even though the production of dioxapyrrolomycin has not increased relative to the other fermentation products. The biological assays used to examine this compound included in vitro effects on the free-living nematode Caenorhabditis elegans, ability to clear target nematodes (Haemonchus contortus and Trichostrongylus colubriformis) from experimentally infected jirds, and clearance of Haemonchus contortus from monospecifically infected lambs, as described in more detail below. Dioxapyrrolomycin is active in the C. elegans in vitro assay at 0.825 ppm. Table I shows results obtained for dioxapyrrolomycin against H. contortus and a second target parasite, T. colubriformis in the jird model. Dioxapyrrolomycin exhibited strong activity (≧90.9% clearance at 0.33 mg/jird=8.25 mg/kg; 96.4% clearance at 0.037 mg/jird=0.925 mg/kg) against this parasite. It also is worth noting that although dioxapyrrolomycin is not highly active against T. colubriformis, it has a hint of activity (41.5% clearance at 0.33 mg/jird=8.25 mg/kg) against this parasite. Table II shows results obtained for dioxapyrrolomycin in sheep against H. contortus (monospecific, experimental infections). Dioxapyrrolomycin exhibited potent activity (92.2% clearance of the worms at 1.56 mg/kg). Having shown potent activity against H. contortus in sheep, dioxapyrrolomycin was examined for cross-resistance to the three major classes of broad-spectrum anthelmintics (ivermectin, levamisole, and benzimidazoles) using jirds infected with resistant strains of H. contortus. The data presented in Table III shows that dioxapyrrolomycin is equally efficacious against the resistant and nonresistant strains studied and hence is not cross-resistant to the major broad-spectrum anthelmintics. Dioxapyrrolomycin does, however, exhibit cross-resistance to closantel, a narrow-spectrum anthelmintic used in controlling H. contortus. In vitro, the dioxapyrrolomycin dose required to affect a closantel-resistant strain of H. contortus is approximately seventeen times that required for the susceptible strain. In summary, dioxapyrrolomycin has activity of potential utility against the important ruminant parasite, H. contortus. Dioxapyrrolomycin appears to have some, albeit very weak, activity against a second ruminant parasite, T. colubriformis. Lack of cross-resistance with the three (3) major classes of broad-spectrum anthelmintics, but cross-resistance with the narrow-spectrum drug closantel, has been demonstrated for dioxapyrrolomycin. Therefore, dioxapyrrolomycin is effective against worms, particularly parasitic worms of warm-blooded animals and more particularly helminth parasites in ovines (sheep) and bovines (cattle). Dioxapyrrolomycin of Formula I can be used as the pure compound or as a mixture of pure compound, but for practical reasons, the compound is preferably formulated as an anthelmintic composition and administered as a single or multiple dose, alone or in combination with other anthelmintics (e.g. avermectins, benzimidazoles, levamisole, praziquantel, etc.). For example, aqueous or oil suspensions can be administered orally, or the compound can be formulated with a solid carrier for feeding. Furthermore, an oil suspension can be converted into an aqueous emulsion by mixing with water and injecting the emulsion intramuscularly, subcutaneously or into the peritoneal cavity. In addition, dioxapyrrolomycin (which hereafter may be referred to as the "active compound") can be administered topically to the animal in a conventional pour-on formula. Pure active compound, mixtures of the active compound, or combinations thereof with a solid carrier can be administered in the animal's food, or administered in the form of tablets, pills, boluses, wafers, pastes, and other conventional unit dosage forms, as well as sustained/controlled release dosage forms which deliver the active compound over an extended period of days, weeks or months. All of these various forms of the active compound of this invention can be prepared using physiologically acceptable carriers and known methods of formulation and manufacture. Representative solid carriers conveniently available and satisfactory for physiologically acceptable, unit dosage formulations include corn starch, powdered lactose, powdered sucrose, talc, stearic acid, magnesium stearate, finely divided bentonite, and the like. The active compound can be mixed with a carrier in varying proportions from, for example, about 0.001 percent by weight in animal feed to about 90 or 95 percent or more in a pill or capsule. In the latter form, one might use no more carrier than sufficient to bind the particles of active compound. In general, the active compound can be formulated in stable powders or granules for mixing in an amount of feed for a single feeding or enough feed for one day and thus obtain therapeutic efficacy without complication. It is the prepared and stored feeds or feed premixes that require care. A recommended practice is to coat a granular formulation to protect and preserve the active compound. A prepared hog-feed containing about 0.02 percent of the active compound will provide a dosage of about 10 mg per kg body weight for each 100 lb pig in its daily ration. A solid diluent carrier need not be a homogeneous entity, but mixtures of different diluent carriers can include small proportions of adjuvants such as water; alcohols; protein solutions and suspensions like skimmed milk; edible oils; solutions, e.g., syrups; and organic adjuvants such as propylene glycols, sorbitol, glycerol, diethyl carbonate, and the like. The solid carrier formulations of the active compound are conveniently prepared in unit dosage forms, to facilitate administration to animals. Accordingly, several large boluses (about 2 g weight) amounting to about 4.1 g of active compound would be required for a single dosage to a 900 lb horse at a dosage rate of 10 mg/kg of body weight. Similarly, a 60 lb lamb at a dosage rate of 10 mg/kg of body weight would require a pill, capsule, or bolus containing about 0.3 g of active compound. A small dog, on the other hand, weighing about 20 lbs. would require a total dosage of about 90 mg at a dosage rate of 10 mg/kg of body weight. The solid, unit dosage forms can be conveniently prepared in various sizes and concentrations of active compound, to accomodate treatment of the various sizes of animals that are parasitized by worms. Liquid formulations can also be used. Representative liquid formulations include aqueous (including isotonic saline) suspensions, oil solutions and suspensions, and oil in water emulsions. Aqueous suspensions are obtained by dispersing the active compound in water, preferably including a suitable surface-active dispersing agent such as cationic, anionic, or non-ionic surface-active agents. Representative suitable ones are polyoxyalkylene derivatives of fatty alcohols and of sorbitan esters, and glycerol and sorbitan esters of fatty acids. Various dispersing or suspending agents can be included and representative ones are synthetic and natural gums, tragacanth, acacia, alginate, dextran, gelatin, sodium carboxymethylcellulose, methylcellulose, sodium polyvinylpyrrolidone, and the like. The proportion of the active compound in the aqueous suspensions of the invention can vary from about 1 percent to about 20 percent or more. Oil solutions are prepared by mixing the active compound and an oil, e.g. an edible oil such as cottonseed oil, peanut oil, coconut oil, modified soybean oil, and sesame oil. Usually, solubility in oil will be limited and oil suspensions can be prepared by mixing additional finely divided active compound in the oil. Oil in water emulsions are prepared by mixing and dispersing an oil solution or suspension of the active compound in water preferably aided by surface-active agents and dispersing or suspending agents as indicated above. In general, the formulations of this invention are administered to animals so as to achieve therapeutic or prophylactic levels of the active compound. At present, it is known that doses of 1.56 to 12.5 mg/kg of body weight in sheep of dioxapyrrolomycin will effectively combat H. contortus. Effective therapeutic and prophylactic dosages are contemplated in the range of about 2 to about 20 mg/kg of body weight. In other animals, and for other kinds of parasitic worms, definitive dosages can be proposed. Contemplated are dosage rates of about 1 mg to about 20 mg/kg of body weight. A preferred, contemplated range of dosage rates is from about 5 mg to about 10 mg/kg of body weight. In this regard, it should be noted that the concentration of active compound in the formulation selected for administration is in many situations not critical. One can administer a larger quantity of a formulation having a relatively low concentration and achieve the same therapeutic or prophylactic dosage as a relatively small quantity of a relatively more concentrated formulation. More frequent small dosages will likewise give results comparable to one large dose. One can also administer a sustained release dosage system (protracted delivery formulation) so as to provide therapeutic and/or prophylactic dosage amounts over an extended period. Unit dosage forms in accordance with this invention can have anywhere from less than 1 mg to 50 g of active compound per unit. Although dioxapyrrolomycin will find its primary use in the treatment and/or prevention of helminth parasitisms in domesticated animals such as sheep, cattle, horses, dogs, swine, goats and poultry, it is also effective in treatment that occurs in other warm blooded animals, including humans. The optimum amount to be employed for best results will, of course, depend upon species of animal to be treated, the regimen treatment and the type and severity of helminth infection. Generally good results are obtained with dioxapyrrolomycin by the oral or parenteral route of administration of about 1 to 10 mg/kg of animal body weight (such total dose being given at one time, in a protracted manner or in divided doses over a short period of time such as 1-4 days). The technique for administering these materials to animals are known to those skilled in the veterinary and medical fields. It is contemplated that dioxapyrrolomycin can be used to treat various helminth diseases in humans, including those caused by Ascaris, Enterobius, Ancylostoma, Trichuris, Strongyloides, Fasciola, Taenia, and/or Onchocerca or other filariae at a dose of from 1 to 20 mg/kg of body weight upon oral and/or parenteral administration. The following detailed examples/procedures describe the biological testing and production of dioxapyrrolomycin and are to be construed as merely illustrative, and not limitations of the preceding disclosure in any way whatsoever. Those skilled in the art will promptly recognize appropriate variations from the procedures. DESCRIPTION OF THE PREFERRED EMBODIMENTS EXAMPLE 1 Caenorhabditis elegans Assay The free-living nematode C. elegans in vitro assay has been described extensively in the literature, for example, K. G. Simpkin and G. C. Coles, J. Chem. Tech. Biotechnol., 31:66-69 (1981). Dioxapyrrolomycin is active in the C. elegans assay at 0.825 ppm. EXAMPLE 2 Haemonchus contortus/Trichostrongylus colubriformis/Jird Assay: This in vivo assay utilizes jirds infected with two important target parasites of ruminants, H. contortus and T. colubriformis (anthelmintic-sensitive or -resistant worms can be used). Initially, activity is assessed only against H. contortus as described in G. A. Conder et. al., J. Parasitol. 76:168-170 (1990), while follow-up studies examine activity against both species of parasites using the techniques outlined in G. A. Conder et at., J. Parsitol. 77:168-170 (1991). Table I shows results obtained for dioxapyrrolomycin in the jird model. EXAMPLE 3 Haemonchus contortus/Sheep Assay: Purpose bred, helminth-free lambs are procured. Upon ardvai, the lambs are treated with ivermectin (0.2 mg/kg, subcutaneously), vaccinated for sore mouth, and placed in a single, community pen. Three weeks later each lamb is treated with levamisole hydrochloride (8.0 mg/kg per os). Two weeks after treatment with levamisole, all lambs are inoculated per os with--7,500 infective larvae of H. contortus. Rectal fecal samples are taken from each lamb 1 to 3 days prior to infection and these are examined using the double centrifugation technique to verify that the animals are free of trichostrongyles prior to infection. On day 32-34 postinoculation (PI), a rectal fecal sample from each lamb is examined again using the McMaster counting chamber technique to verify infection; those animals which do not exhibit suitable infection are dropped from the study. Remaining lambs are treated per os on day 35 PI; 4-5 animals receive vehicle only. Prior to administration, test materials are prepared in a manner suitable for the substance being examined. All lambs are monitored for toxic signs following treatment. Lambs are killed 7 days after treatment (day 42 PI), and the abomasum is ligated and removed from each animal. Each abomasum is opened longitudinally and the contents rinsed into an 80 mesh sieve. Sieve contents are collected in individual containers and fixed in formol-alcohol. Later each sample is transferred to a 1,000 ml graduated cylinder and the volume brought to 400-1000 ml with tap water. The total number of worms in a 10% aliquot is determined. If no worms are found in the 10% aliquot, the entire sample is examined. Total worm number/lamb and percentage clearance for each treatment are calculated. Percentage clearance is determined according to the following formula: Percentage clearance=[(Mean number of worms recovered from vehicle control lambs--number of worms recovered from treated lamb)/mean number of worms recovered from vehicle control lambs]×100. A substance is considered highly active if its clearance is ≧90% and moderately active if its clearance is ≧70 but <90%. Table II shows results obtained for dioxapyrrolomycin in sheep against H. contortus (monospecific, experimental infections). EXAMPLE 4 Production and Isolation of Dioxapyrrolomycin Bacterial Culture Streptomyces sp. 90413 (strain number in Upjohn Culture Collection, 90413, UC® 11065, The Upjohn Co., Kalamazoo, Mich.) is isolated from Michigan soil and maintained as frozen agar plugs of vegetative growth in a liquid nitrogen vapor phase. It is believed that other known dioxapyrrolomycin-producing Streptomyces sp., such as those identified in G. T. Carter, et al., J. Antibio. 40:233 (1987), and H. Nakamara, et at., J. Antiobio. 40:899 (1987), would be suitable substitutes for the above species in the process of the present example. Fermentation Conditions Primary fermentations in medium CBS 10 are carded out in 100 ml volumes in shaken flasks. Shake flask fermentations are run for 72 hours in 100 ml volumes in 500 ml wide-mouth flasks at 28° C. (250 rpm, 1.5 inch throw). Shake flask pools (2 and 3 liter) are inoculated from 100 mi seed shake flask cultures (medium GS-7:25 g/l cerelose, 25 g/l Pharmamedia, pH=7.2 with NH 4 OH, autoclaved 30 minutes) at a 5% (v/v) rate. Production Fermentations using Neutral Resins The organism is inoculated into medium GS-7. The inoculated 100 ml volumes of GS-7 are fermented for 72 hours as described above. The mature seed cultures are used as the source of inoculum (5% seed rate) for the fermentation medium (CBS 10 containing XAD-2). CBS-10 is composed of Difco soluble starch 20 g; solulys, 20 g; beef extract 4 g; NaCl 5 g; and tap water, quantity sufficient (qs) 11. Neutral resin (XAD-2) is incorporated into CBS 10 before autoclaving in flasks at a final concentration of 60 g/l. In tank fermentations, sterile XAD-2 is added 2-3 hours post inoculation at a final concentration of 50 g/l. The pH of the fermentation medium is adjusted to 7.2 using KOH before autoclaving (30 min/flask, 90 min/tank). Inoculated flask fermentations are employed in the manner described for GS-7 above for four days of fermentation. Inoculated 10 L tank fermentations (Labraferm) are stirred at 250 rpm at 28° C. with an air flow rate of 6-7 l/min for 4-5 days of fermentation. Sample Preparation, Assay and Harvesting Assay samples from shake flask fermentations (1.5 ml) are centrifuged and the clear supernatants are transferred to 1.2 ml microtubes. Samples are assayed for activity as described in the examples above. Extraction Procedure Filter whole beer at harvest pH (celaton FW-40 filter aid may be used if desired). The clear filtrate may be discarded. Process the mycelial cake as described below. The XAD-2 resin remains in the mycelial cake during filtration and should be processed as part of the cake. Trituration of the Mycelial Cake with Acetone 1. Stir mycelial cake three times with 1/6 original beer volumes of acetone each time (ACETONE-1 ,-2,-3). Combine acetone extracts 1, 2 & 3 and process as described below. Extraction of Aetone Pool 1. Add 1/2 pool volume of methylene chloride to the acetone pool. Separate organic phase (lower) from the aqueous acetone phase (upper). Aqueous phase may be discarded. Dry MeCl 2 /acetone organic phase over Na 2 SO 4 and concentrate to an oil in vacuo (preparation A). Preparation A should then be fractionated by silica gel column chromatography as described below. Silica Gel Column Chromatography 1. An open silica gel (70-230 mesh) column * is poured and equilibrated in two bed volumes of n-hexane. Preparation A from above is absorbed onto 2 times its weight of silica gel and loaded onto the head of the column. 2. The silica gel column is then eluted** in the following manner: start: 2 - bed volumes n-hexane 4 - bed volumes 85 hexane: 15 EtOAc end: 2 - bed volumes EtOAc 3. Silica column pools are collected in bed volume aliquots as described below: Pool A: bed volumes 1 & 2 (discard) Pool B: bed volume 3 Pool C: bed volume 4 Pool D: bed volume 5 Pool E: bed volume 6 Pool F: bed volumes 7 & 8 4. The above silica column pools B - F are then concentrated to dryness in vacuo. Pool D will contain the majority of dioxapyrrolomycin and will be referred to as preparation B. Pools C and E may contain small quantities of dioxapyrrolomycin. Verification of silica pool compositions may be done by the analytical HPLC procedure described below. Analytical HPLC of Preparation B 1. Analytical HPLC for sample analysis and peak identification was performed on a Hewlett Packard (HP) 1090A with Diode Array Detector (DAD) and HP PC work station. Separation was performed on an HP 2.1 mm×200 mm ODS (Hypersil) RP (5 um) column preceded by an HP ODS guard column. Elution was achieved with isocratic 65% ACN:35% NH 4 OAc (pH=4.0) for 5.0 minutes followed by a 20 minute linear gradient to 100% ACN. Column temperature was maintained at 65° C. and column eluant was monitored by UV detection @240 nm. Mobile phase flow rate was maintained at 0.5 ml/min throughout the entire separation. Sample injections of 1.0-25.0 mcl were performed automatically by the HP 1090A HPLC. The relative retention time of dioxapyrrolomycin under these analytical HPLC parameters is 1.4 minutes and peak identification is verified by dioxapyrrolomycin's characteristic UV spectrum recorded by the DAD. Once the composition of preparation B has been verified by analytical HPLC, the final recovery of pure dioxapyrrolomycin from preparation B was carried out by preparative HPLC as described below. Preparative HPLC Purification of Dioxapyrrolomycin from Preparation B Preparative HPLC for purification of dioxapyrrolomycin from preparation B was performed on a Waters prep LC 3000 with a variable wavelength UV/VIS detector and Waters 745B integrator. Separation was performed on three Waters Radial Pak C-18 (25×100 mm) columns in series with a Waters 25×10 mm Radial Pak C-18 guard column. Elution was achieved with isocratic 60% ACN: 40% NH 4 OAc (pH=4.0) for 25 minutes. Column was maintained at ambient temperature with column eluant monitored by UV detection @254 nm. Mobile phase flow rate was maintained at 34.2 ml/min throughout the entire separation. Sample injections were pumped directly onto the head of the column with maxima injection volumes of 50.0 ml. The retention time of dioxapyrrolomycin under these preparative HPLC parameters ranges between 9.00 and 12.00 minutes depending on sample load. Baseline resolution of dioxapyrrolomycin is achievable under these parameters; however, purity of preparative HPLC fractions should be checked by analytical HPLC analysis prior to pooling of preparative fractions. Excess NH 4 OAc buffer from the preparative HPLC procedure was removed from the sample by absorbing the dioxapyrrolomycin onto HP-20 resin and washing of the resin with water. The dioxapyrrolomycin was then recovered from the resin by extraction with MeOH. Crystalline dioxapyrrolomycin (preparation C) is the resulting product of this final purification stage. Verification of the structure of preparation C, was then accomplished by the spectroscopic and analytical analysis described below. Identification of Dioxapyrrolomycin Preparation C (1) was obtained as fine yellow needles. The UV spectrum of 1 suggested 1 is structurally related to pyrrolomycins. Computer search of the IR spectrum of 1 against the spectrum library identified dioxapyrrolomycin as the most likely structure. Comparison of these spectra, with published UV and IR spectrum of dioxapyrrolomycin showed that they are virtually superimposable. The elemental analysis results (37.4% C, 1.5% H, 7.0% N, 36.5% Cl) of 1 are consistent the molecular formula of dioxapyrrolomycin (C 12 H 6 N 2 O 4 Cl 4 which predicts 37.5% C, 1.6% H, 7.35 N, 37.0% Cl). FAB-MS spectrum of 1 displayed a weak ion cluster (m/e=382, 384, 386), expected for the (M+H) + ions of dioxapyrrolomycin. The most intense peaks at 306, 308, and 310 represent the loss of one nitro and one formaldehyde (M--NO 2 --CH 2 O) from molecular ions. The HMR spectrum (obtained in CDCl3) of 1 displayed only one exchangeable proton at 9.14 ppm, due to the pyrrole proton. The higher field position of this proton, compared to the similar situated proton in pyrrolomycin C, is attributed to the absence of a neighboring carbonyl group. A total of five non-exchangeable protons were detected between 5 and 8 ppm region. The AB quartet (5.58, 5.37 ppm, J=6.2 Hz) is consistent with the presence of a mythylenedioxy group. The sharp singlet (6.85 ppm) is consistent with the presence of a carbinol proton sandwiched between two aromatic systems. The two long-ranged coupled protons at 7.31 and 6.88 ppm (J=2.1 Hz) are consistent with the presence of a 1,2,3,5 tetrasubstituted phenyl group. Again, the relative deshielding of these two protons, compared to pyrrolomycin C, is attributed to the reduction of the carbonyl group to the methyleneoxy functionality. The CMR signals of 1 (75 MHz, deuterated MeOH) are as follows: δ 146.2 (s), 131.5(s), 130.5(d), 130.4(s), 127.3(s), 126.1(d), 125.5(s), 124.0(s), 117.5(s), 106.0(s), 92.3(t) and 70.4(d). While all of above signals (chemical shift and multiplicities) agree well with the structure of dioxapyrrolomycin, small differences were observed between these and the reported values (8) (obtained in CDCl3) as a result of solvent effects. Since the structure of dioxapyrrolomycin contains an optical center, ORD of 1 was obtained (c=2.23, MeOH) to determine the chirality of 1. The result (-77°) is in fair agreement with the reported value (-88°) of dioxapyrrolomycin therefore indicated that 1 has same absolute configurations as that of dioxapyrrolomycin. TABLE I__________________________________________________________________________Percentage Clearance of Haemonchus contortus and Trichostrongyluscolubriformisfrom jirds inoculated per os with ˜1,000 exsheathed, infectivelarvae of each parasite,treated per os with dioxapyrrolomycin on day 10 postinoculation (PI) andnecropsied onday 13 postinoculation.Compound Dose n (survived Percentage Clearance(Reference) Purity (mg/jird) to necropsy) H. contortus T. colubriformis__________________________________________________________________________Dioxapyrrolomycin ˜100% 0.33 3(1) 90.9 41.5 0.33 3(3) 100 41.5 0.11 3(3) 100 0 0.037 3(3) 96.4 17.2 0.012 3(3) 45.8 48.8__________________________________________________________________________ TABLE II______________________________________Percentage clearance of Haemonchus contortus from lambs mono-specifically inoculated per os with ˜7,500 infective larvae of theparasite, treated per os with dioxapyrrolomycin on day 35 post-inoculation (PI), and necropsied on day 42 PI.Compound Dose Percentage(Reference) Purity (mg/kg) Clearance______________________________________Dioxapyrrolomycin ˜100% 12.5 100 6.25 99.9 3.125 99.7 ˜100% 3.125 99.9 1.56 92.2 0.78 44.0______________________________________ TABLE III__________________________________________________________________________Percentage clearance of susceptible, levamisole/benzimidazole-resistant,orivermectin-resistant Haemonchus contortus from jirds inoculated per oswith˜1,000 exsheathed, infective larvae of a particular strain of theparasite, treated peros with dioxapyrrolomycin, levamisole hydrochloride, albendazole, orivermectinon day 10 postinoculation (PI), and necropsied on day 13 PI. Percentage Clearance Levamisole/Compound Dose Benzimidazole Ivermectin(Reference) Purity (mg/jird) Susceptible Resistant Resistant__________________________________________________________________________Dioxapyrrolomycin 95%* 0.11 95.8 98.6 92.7Levamisole hydro- 0.4 ˜95.0 51.7 96.4chlorideAlbendazole 0.075 ˜95.0 36.2 N.D.Ivermectin 0.005 ˜95.0 98.6 18.7__________________________________________________________________________ *Pyrrolomycin C makes up the majority of the remainder. N.D. = Not Done. ##STR2##

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from U.S. Provisional Application No. 61/286,668 filed Dec. 15, 2009, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention relates to compositions for topical delivery of active agents. The compositions relate to delivery of active agents to the skin with reduced toxicity such as drying, irritation, or inflammation. The inventive composition is related to delivery of topical agents such as retinoids to the skin. BACKGROUND OF THE INVENTION [0003] Lipophilic skin care active agents such as retinoids are generally applied topically to reduce the appearance of aging, for other cosmetic purposes, or to treat a skin condition such as acne. [0004] The comfort associated with application of topical agents is related in part to the rate of evaporation of the applied composition on the skin. A product with a slow evaporation rate could feel greasy on the skin whereas a product with an overly rapid evaporation rate feels either as if it has not been applied to the skin at all or leaves the user with the impression that not enough has been applied possibly leading to overuse. Combining topical agents with volatile silicones allows the proper evaporation rate to provide a pleasing application. Silicones, however, by themselves are poor solvents for hydrophobic organic active agents. [0005] To address the poor solubility in silicones, delivery systems for these agents commonly require 35% or more organic solvent as a carrier to solubilize the active agent as well as provide suitability for combination with volatile compounds that provide pleasing application by the user. The prior art prefers alcohols such as ethyl alcohol as an organic solvent. [0006] Many active agents contribute to thinning or drying of the skin. This problem is worsened by including significant levels of organic solvents that themselves can alter epidermal barrier lipids and contribute to skin irritation. Ethyl alcohol, as used in the retinoid composition of U.S. Pat. No. 4,826,828, incorporated herein by reference, was believed to be the solution for topical delivery of hydrophobic agents. Ethyl alcohol, to the contrary, contributes to skin irritation and dryness. Thus, combining ethyl alcohol with potentially irritating active agents increases skin dryness leading to non-optimal use. [0007] Thus, there exists a need for a hydrophobic active agent delivery system that provides pleasing application and does not contribute to toxicity. SUMMARY OF THE INVENTION [0008] The following summary of the invention is provided to facilitate an understanding of some of the innovative features unique to the present invention and is not intended to be a full description. A full appreciation of the various aspects of the invention can be gained by taking the entire specification, claims, drawings, and abstract as a whole. [0009] An active agent delivery composition is provided that creates pleasing administration of an active agent to the skin of a subject without a greasy feeling residue. An inventive composition includes an active agent illustratively: vitamin A or its derivatives; hydroxy acids; benzoyl peroxide; resorcinol; antimicrobials; anti-neoplastic agents; anti-viral agents; nonsteroidal anti-inflammatory agents; UV filters; lipids; and immunomodulators. An active agent is optionally vitamin A or a derivative thereof present at between 0.001 to 2 weight percent. Optionally, a vitamin A derivative is retinal, retinoic acid, retinyl ester, retinol, tretinoin, isotretinoin, adapalene, tazarotene, or combinations thereof. An active agent is optionally salicylic acid, acetylsalicylic acid, or combinations thereof [0010] The inventive composition provides for pleasing skin administration through the use of a silicone carrier that is optionally a linear aliphatic polyorganosiloxane, optionally ethyl trisiloxane. [0011] A polyhalogenic vehicle is present in the inventive composition to solubilize the active agent with the carrier while reducing or eliminating the need for an organic solvent such as ethanol. A vehicle is optionally a perfluoro ether, optionally, methoxyonafluorobutane or ethoxyonafluorobutane. The vehicle is optionally present from about 15 to 25 percent by weight. [0012] An optional organic solvent is included. Optionally, the organic solvent is present at less than 25 percent by weight. Optionally, the organic solvent is present at less than 5 percent by weight. [0013] Also provided is a process of treating a skin condition in a subject. The skin condition may be, for example, acne, wrinkles, dryness, cancer, or perspiration. The inventive process includes applying an inventive composition to the skin of a subject. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0014] It is to be understood that the present invention is not limited to particular embodiments described, which may, of course, vary. It is also to be understood that the teuninology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. [0015] The invention has utility for topical delivery of active agents. The invention has more specific utility for the delivery of hydrophobic active agents to the skin with reduced agent or solvent related side effects and improved comfort and user compliance. [0016] The inventive composition includes an active agent combined with a carrier and a compatible vehicle. [0017] As used herein the term “active agent” refers to a molecule suitable for delivery to the skin or mucosal regions of a subject. Optionally, an active agent has pharmaceutical activity and is present for the treatment or prevention of a skin condition. Active agents are optionally low polarity molecules such as those having a hydrocarbon chain of three or more carbons, but may also comprise materials of higher polarity. Examples of active agents illustratively include: vitamin A or its derivatives; hydroxy acids; aromatic molecules such as benzoyl peroxide and resorcinol; antimicrobials such as azelaic acid, erythromycin, sodium sulfacetamide, tetracycline and derivatives, and clindamycin; anti-neoplastic agents and/or ophthalmic agents illustratively including 5-fluorouracil, doxorubicin, imiquimod, and sodium [o-(2,6-dichloranilino) phenyl] acetate; anti-viral agents illustratively ganciclovir, trifluorothymidine and related compounds; nonsteroidal anti-inflammatory agents illustratively flurbiprofen, ibuprofen, naproxen, indomethacin and related compounds; anti-mitotic drugs illustratively colchicine taxol and related compounds; drugs that act on actin polymerization illustratively phalloidin, cytochlasin B and related compounds; inhibitors of dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP) and/or uridine phosphorylase (UP) enzyme inhibitors; ultraviolet light (UV) filters illustratively benzophenone derivatives such as oxybenzone, octocrylene, octyl methoxycinnamate, and avobenzone; radiation proactive agents illustratively methyluracils such as 6-methyluracil and 4-methyluracil; and immunomodulating molecules such as tacrolimus, and pimecrolimus. An active agent need not have pharmaceutical activity. Other active agents are illustratively cosmetics such as pigments, dyes, and fillers. It is appreciated that an inventive composition optionally includes more than one active agent. Optionally, 2, 3, 4, 5, 6, or more active agents are present in an inventive composition. An active agent is optionally a prodrug that is converted to a desired active species optionally in the skin or layer thereof. [0018] An active agent is optionally a lipid such as those suitable for controlling perspiration. Lipids optionally have an HLB of less than about 12, less than about 8, or optionally less than about 6. Illustrative examples of lipids include glyceryl monostearate, glyceryl monoisostearate, glyceryl monomyristate, glyceryl monoleate, diglyceryl monoisostearate, propylene of glycol monostearate, propylene glycol monoisostearate, propylene glycol monocaprylate, sorbitan monoisostearate, sorbitan monocaprylate, sorbitan monoisooleate, glyceryl monolaurate, glyceryl monocaprylate, glyceryl monocaprate, mixtures thereof or the like. Optionally, the lipid is glyceryl monolaurate, made available by suppliers like Fitz Chem Corporation under the name MONOMULS 90-L12. [0019] Typically, the lipid makes up from about 4 to about 35%, and optionally, from about 5 to about 20%, and optionally, from about 10 to about 15% by weight of the composition, based on total weight of the composition and including all ranges subsumed therein. [0020] Examples of pigments illustratively include inorganic or organic molecules such as molecules in the form of metal lakes. Pigments are illustratively made of titanium dioxide, zinc oxide, D&C Red No. 36 and D&C Orange No. 17, calcium lakes of D&C Red No. 7, 11, 31 and 34, barium lake of D&C Red No. 12, D&C Red No. 13 strontium lake, aluminum lakes of FD&C Yellow No. 5, of FD&C Yellow No. 6, of D&C Red No. 27, of D&C Red No. 21 and of FD&C Blue No. 1, iron oxides, manganese violet, chromium oxide and ultramarine blue. [0021] Examples of vitamin A or its derivatives illustratively include retinoids such as retinal, retinoic acid, retinyl ester, retinol, tretinoin, isotretinoin, adapalene, tazarotene, and the like. [0022] Examples of hydroxy acids illustratively include beta hydroxy acids such as salicylic acid, acetylsalicylic acid, and the like. [0023] While the description uses retinol as an illustrative example of an active agent, the specification is not limited as such. Other active agents are similarly operable herein. [0024] Numerous skin or systemic conditions are treatable with the inventive composition illustratively including acne, wrinkles, dryness, eczema, psoriasis, actinic and nonactinic keratoses, rosaceous, among others. U.S. Pat. No. 3,932,665 described retinal as a therapeutic agent in a method for treating acne by topical application. The disclosure of U.S. Pat. No. 3,932,665 is accordingly hereby incorporated by reference. The topical administration of 5-fluorouracil for treatment of keratoses is described in U.S. Pat. No. 4,034,114, the contents of which are incorporated herein by reference. The inventive composition reduces the associated side effects that typically accompany topical or ophthalmologic administration of active agents. [0025] The inventive composition is suitable for topical delivery of an active agent. The inventive composition illustratively includes a retinol formulated in a carrier containing volatile silicone. With such a carrier, retinol levels needed to achieve beneficial effects are minimized and the potential for irritant effects to the skin by retinol are greatly diminished. Moreover, retinol is stable when formulated in the silicone containing compositions of the invention in contrast to other conventional carriers. [0026] The compositions of the invention may include 0.005 to 1.0 weight percent retinol, in which case they are optionally applied directly to the skin, or supplied as more concentrated solution containing higher levels of active agent, in which case prior to application they are diluted optionally by means of a cosmetically acceptable carrier to a desired level such as 0.005 to 1.0 weight percent for retinol. In the formulations of the invention, water is optionally minimized or eliminated to improve the stability of retinol and to minimize the potential for separation of the oil and water. Optionally, water is present at less than 2%. One of ordinary skill in the art will recognize that differing levels of active agent will be operable herein depending on the desired final amount of active agent. [0027] Optionally, active agent is present in less than 30 percent w/w amounts. Optionally, active agent is present at a weight percent of 30, 29, 28, 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 0.1, 0.01, 0.001, 0.0001, any level in between or any range therein. Optionally, active agent is present at 20 percent w/w. Illustratively, when azelaic acid is an active agent it is present at 15 to 25 percent w/w. A vitamin A derivative is optionally present at 0.001 to 2 percent by weight. Imiquimod is optionally present at 3 to 8 percent by weight. Benzoyl peroxide is optionally present at 1 to 10 percent by weight. It is within the skill of the art to determine the optimal level of active agent in either a concentrated solution or a final solution for application. [0028] An active agent is preferably provided in a carrier. A carrier is optionally present from 10 to 75 percent w/v. Carriers are optionally volatile compounds such as volatile silicones. Silicones are illustratively cyclic silicones or non-cyclic silicones. Examples of cyclic silicones illustratively include cyclic polydiorganosiloxanes, cyclotetradimethicones and cyclopentadimethicones. Linear organopolysiloxanes are illustratively alkyl-, alkoxy- or phenyldimethicones, and alkyl-, alkoxy- or phenyltrimethicones. Optionally, a carrier is an aliphatic volatile silicone. Aliphatic volatile silicones optionally have from two to six silicon atoms. Optionally, an aliphatic volatile silicone is a linear polyorganosiloxane such as a polyorganosiloxane with 2 to 6 silicon atoms, optionally, trisiloxane. Optionally, a carrier is ethyl trisiloxane. It is appreciated that an inventive composition optionally includes more than one carrier. [0029] Volatile silicones optionally are lightweight carriers that evaporate on application and thus have an elegant, light-weight “feel” on the skin. Volatile silicones are typically limited in their ability to dissolve low polarity (i.e. usually greater than C7-C8)) organic compounds like retinoids. For example, when relatively low therapeutic levels of retinol (0.1-0.2% w/v) are dissolved in cyclomethicone alone, hazy solutions result due to incomplete solubilization by the silicone fluid. [0030] Among the nearly infinite possibilities of vehicles that could function with both an active agent and a volatile silicone, it was unexpectedly discovered that an organic polyhalogenic vehicle could incorporate a retinoid at appropriate therapeutic levels and reduces the levels of hydrocarbon solvent to less than 5 percent in contrast to US Patent No. 4,826,828 which required 35-60 percent w/w hydrocarbon solvent. This discovery is interesting due to the fact that organic polyhalogenic vehicles are poor solubilizers of molecules such as retinoid on their own. Combined with the knowledge that silicones are poor solvents, one or ordinary skill in the art has no expectation of success combining two poor solubilizers to faun a system that effectively solubilizes active agents. Organic polyhalogenic solvents are optionally those disclosed in U.S. Pat. No. 6,251,375, the contents of which are incorporated herein by reference. In particular instances, vehicles incorporate a halogen such as one or more fluorine atoms. In some specific instances, a vehicle is a perfluoro ether. In some particular instances, a vehicle is methoxyonafluorobutane or ethoxyonafluorobutane available from 3M Specialty Materials, St. Paul, Minn. A vehicle optionally has a boiling point less than 78° C. Optionally, a vehicle has a boiling point below 65° C. A vehicle is optionally present at a final concentration of about 5 percent to 40 percent w/w. Optionally, a vehicle is present at from 15 percent to 25 percent w/w. Optionally, a vehicle is present at 20% w/w. It is appreciated that more than one vehicle is optionally present in an inventive composition. Optionally, 2, 3, 4, 5, 6, or more vehicles are present in an inventive composition. [0031] The inventive composition is optionally formulated with levels of organic solvent. An organic solvent is optionally volatile at ambient temperatures and pressures. Optionally, less than 35% organic solvent is included. Optionally, less than 30% organic solvent is included. Optionally, the level of volatile organic solvent is less than 15 percent w/w. Optionally, an organic solvent is present at 5% or less w/w. Optionally, an organic solvent is absent. An organic solvent is optionally an alcohol, illustratively ethanol. Optionally, an alcohol is an ethoxydiglycol, ethanol, or isopropyl alcohol. Optionally, an organic solvent is ethoxydiglycol present at 10 percent w/w or less. Optionally, ethoxydiglycol is present at 3 percent w/w. The level of organic solvent optionally does not induce noticeable drying or other toxic effects on the skin as opposed to the prior art that requires volatile organic solvents such as ethanol at much higher concentrations. It is appreciated that more than one organic solvent is optionally present in an inventive composition. It is further appreciated that the inventive composition be entirely ethanol free. [0032] It is a particularly unexpected and surprising discovery of the subject invention that stable solutions of active compounds in the carrier can be prepared with less than 15 percent w/w organic solvent when combined with a vehicle at 5 percent to 40 percent w/w. It is particularly surprising that a vehicle at 5 percent to 40 percent w/w can promote a stable soluble solution with less than 5% organic solvent. [0033] The inventive composition optionally includes other additives or pharmaceutical carriers illustratively including: stabilizers such as the anti-oxidant BHT; surfactants illustratively Laureth-4; anti-oxidants illustratively vitamins C and E, and Green tea extract (i.e. Camellia sinensis ) or SILOX GT from Collaborative Labs, Stony Brook, N.Y.; and emollients illustratively the mixture or single components of the emollient sold under the brand name SYMREPAIR available from Symrise, Teterboro, N.J. One of ordinary skill in the art readily appreciates additives suitable for use with the present invention such as to provide desired flow characteristics, absorption, evaporation, delivery of active agent, conversion of a prodrug, or other desired characteristic. [0034] The compositions of the invention are also optionally diluted to the appropriate active agent level for application by using other topically acceptable compounds or vehicles which are optionally miscible with the retinol or other active agent of the invention. Other cosmetic additives are optionally employed, either in the compositions of the invention or in those compositions when diluted with a suitable vehicle. [0035] The compositions formulated as described herein are optionally topically applied to the skin on concentration which result in application of 0.005 to 1.0 weight percent retinol, optionally 0.01 to 0.50 weight percent. An active agent is optionally applied in the areas where fine lines, wrinkles, dry or inelastic skin or large pores are observed. Optionally, a moisturizer is applied with or after application of the inventive compositions to enhance the tactile comfort associated with application of the compositions and to enhance the wrinkle effacement and other benefits achieved by the compositions. An improved characteristic of the inventive composition is that the use of additional moisturizers is not required. [0036] Optionally, moisturizing efficacy is achieved in the compositions of the present invention containing the retinol, thereby precluding the need for a separate moisturizer. Therefore, optional compositions of the invention are formulated to include moisturizing components that are compatible with the silicone carrier to a level of up to 35% by weight of the final formulation. Preferred moisturizing ingredients suitable for use the preferred compositions of the invention are illustratively petrolatum, ethylhexyl palmitate, cholesterol fatty acid ceramide, and squalene. The addition of one or more moisturizing components is beneficial when the inventive composition is applied to previously dried skin or under conditions where dryness commonly occurs such as in cold climates, or winter months. Optionally, a moisturizing component is applied where the active agent itself has a drying effect such as when retinol or 5-fluorouracil is applied. [0037] With daily application of a retinol containing composition, skin texture, color and tone will improve. Wrinkles and fine lines will be reduced with minimal irritant effects. [0038] An inventive composition is optionally applied to the skin of a subject. A subject is optionally a patient. A subject is optionally a mammal such as humans, non-human primates, horses, goats, cows, sheep, pigs, dogs, cats, and rodents. [0039] An inventive composition is optionally provided as a lotion, cream, gel, bar, ointment, or in pad form. Optionally, the composition is provided in a single use container the contents of which are applied directly to the stratum corneum of a subject or applied to an applicator pad for subsequent delivery to the subject. [0040] A cooling effect is optionally observed upon application of the inventive composition. Cooling effect as used herein means reducing the temperature of skin, optionally, from about 1 to about 2° C. upon application. The cooling effect includes the effect that results from carrier or vehicle evaporation. [0041] The inventive composition is optionally administered one to three times daily. Optionally, the inventive composition is delivered once daily. Optionally, the inventive composition is administered weekly, biweekly, monthly, or any subdivision thereof. It is appreciated that the inventive composition be administered for an amount of time suitable for efficacy of the active agent. Optionally, the inventive composition is administered for one to six weeks. Optionally, the inventive composition is administered indefinitely. [0042] Also provided is a process of formulating an inventive composition optionally for pleasing administration to the skin of a subject. An inventive process illustratively includes making a first solution by solubilizing one or more active agents optionally in an organic solvent preferably performed with gentle mixing in low to no light conditions. [0043] A second solution is made by mixing additives such as emollients and vitamins. The second solution is added to and mixed with the first solution. Mixing is preferably in the dark under gentle mixing conditions. [0044] A third solution of carrier and vehicle is made and the third solution is added to the combined first and second solutions to form a composition. Mixing is optionally non-vortex, gentle mixing in low light or darkness. Mixing is preferably for 120 minutes. The composition is preferably stored under inert gas such as nitrogen gas. [0045] It is appreciated that low to no light conditions are important should light sensitive components be present in the subject invention. In the absence of light sensitive components, the inventive process is optionally performed in ambient or other lighting conditions. [0046] The inventive process is optionally performed at ambient temperature and pressure conditions. Optionally, the inventive process is performed by heating one or more components or solutions. [0047] Various aspects of the present invention are illustrated by the following non-limiting examples. The examples are for illustrative purposes and are not a limitation on any practice of the present invention. It will be understood that variations and modifications can be made without departing from the spirit and scope of the invention. One of ordinary skill in the art readily knows how to synthesize or commercially obtain the reagents and components described herein. EXAMPLE 1 [0048] A Formula A composition is mixed containing 3.0 percent ethoxydiglycol, 0.5 percent Laureth-4, 0.10 percent hydroxypinnacolone retinoate, 0.05% BHT, 2.0 percent SYMREPAIR, 2.0 percent Tetrahexyldecyl ascorbate, 0.50 percent Tocopherol, 20 percent methoxyonafluorobutane, 1.0 percent SILOX GT, and the remainder Ethyl trisiloxane. [0049] Formula A is prepared by creating solution 1 containing Ethoxydiglycol (Transcutol CG purchased from Gattefosse, Toronto, ON, Canada), Laureth-4 (Croda, Edison, N.J.), Hydrocypinnacolone retinoate (MDI-101, Concert LLC) and BHT by gentle mixing in a propeller mixer using low light conditions. Solution 2 is prepared separately. Solution 2 includes SYMREPAIR (Symrise, Inc., Teterboro, N.J.) which includes hexyldecanol, bisabolol, cetyl hydroxyproline palmitate, steraic acid, and Brassica campestris sterols. SYMREPAIR is mixed with tetrahexyldecyl ascorbate (BV-OSC, Barnet, Englewood Cliffs, N.J.) and tocopherol USP in a propeller mixer until a clear solution forms. Solution 1 is combined with solution 2 by slow addition with continuous, non-vortex propeller mixing protecting the solutions from light. Solution 3 is prepared by gentle propeller mixing at ambient temperature. Solution 3 includes ethyltrisiloxane (Silsoft ETS, Monentiv, Albany, N.Y.), CF-61 (3M Specialty Materials) and SILOX GT (combination of cyclopentasiloxane and Camellia sinesis leaf extract from BASF Beauty Care). The combined solutions 1 and 2 are slowly added to solution 3 the continuous, non-vortex propeller mixing protected from the light. Mixing is continued for 120 minutes. [0050] Formula A is transferred to opaque holding containers with nitrogen head-space for storage. 60 mL of Formula A is then transferred to 2 oz. amber glass bottles with a purified nitrogen gas head-space and stored protected from light until used. [0051] A comparator solution is made containing 46.3% Cyclomethicone-Tetramer; 35% Alcohol SD 40B Anhydrous; 5% Ethylhexyl Palmitate; 5% Octyl Dimethyl PABA; 2% Benzophenone-3; 2% Demineralized Water; 2% Neopentyl Glycol Dicaprate; 1.5% Ethyl Cellulose K5000; 0.22% Butylated Hydroxytoluene; and 1% Retinoid Blend. Formula B is prepared essentially as described in U.S. Pat. No. 4,826,828, the contents of which are incorporated herein by reference. EXAMPLE 2 [0052] A split face test is performed by using Formula A or the comparator as follows. Twelve females aged 20 to 59 apply Formula A to one side of their faces and comparator to the other side once daily for eight weeks. Thin shavings of the skin on each side of the face are taken before the test begins and after the eight week test period. The skin shavings after the test are in better condition than those before the test in all twelve women in the Formula A group and in nine of the twelve women in the comparator group. The skin of all women is both thicker and more organized after the test than before. All women in the Formula A group report improved moisture in the tested skin whereas the comparator group issues complaints of drying and cracking of the tested skin areas. EXAMPLE 3 [0053] The ability of an electric current to flow through the stratum corneum provides an indirect measurement of the corneum's water content. The panelists who participated in the study in Example 2 are assessed for moisturization using an IBS impedance/conductance meter. At least twelve hours elapse between the last product application and the skin conductance measurement. The data demonstrate that the Formula A treated side is moister (higher conductance readings at all measurement time points) than comparator side. The comparator side of the face fails to show similar levels of relative moisture content. Thus, the objective measurement and substantiation of the stratum corneum's electrical conductivity shows a significant enhancement in facial skin moisture content. EXAMPLE 4 [0054] A test of the ability of the Formula A composition of Example 1 relative to the comparator to reduce skin dryness is performed with or without supplemental moisturizer. Twelve panelists who demonstrate skin dryness upon repeated soap washing of the hands are selected to participate in this study. Initially, the panelists induce a condition of dryness by washing their hands with bar soap. The test formulations are applied daily to one hand while the other is left untreated to serve as a control side. Each hand is rated randomly by two trained evaluators who have no knowledge of which hand is treated. The evaluators use a stereomicroscope to assist them with their ratings. The results of this study demonstrate that the unmoisturized comparator side shows additional dryness compared to the control hand. This level of dryness is improved by application of moisturizer after each comparator application. In contrast, Formula A treated hands show marked improvement in moisture content. The addition of moisturizer after each Formula A application does not appreciably improve the treated skin moisture content. The Formula A benefits persist for twenty-four hours after the final treatment indicating that the Formula A composition provides effective long-lasting moisturization. EXAMPLE 5 [0055] A Formula C solution is prepared wherein the active ingredient is benzoyl peroxide at 2.5 percent weight percent final. A phase 1 solution is prepared at ambient temperature by combining dimethyl isosorbide at 15% w/w final, ethanol (SD-Alcohol 40-B, 200 proof) at 4.7% w/w final, Laureth-4 at 1% w/w final, and benzoyl peroxide at 2.5% w/w final. The phase 1 ingredients are combined with continuous non-vortex propeller mixing. [0056] Phase 2 is formed by combination of Methyl perfluorobutyl ether (and) Methyl perfluoroisobutyl ether (CF-61) at 35% w/w final and the remainder ethyl trisiloxane with continuous non-vortex propeller mixing until a clear solution is formed. [0057] Phase 2 is slowly combined with phase 1 with continuous non-vortex propeller mixing. If a hazy solution is observed it will clarify upon standing for 24-48 hours at ambient temperature. [0058] Formula C is stored in 60 ml volumes with absorbent applicator pads. EXAMPLE 6 [0059] Patients presenting with acne to a dermatologist provide informed consent to a split face test comparing Formula C of Example 5 with a commercially available benzoyl peroxide topical acne treatment of equal active ingredient concentration (STRIDEX POWER PADS, Blistex, Inc. Oak Brook, Ill.). [0060] Fifteen females aged 20 to 39 apply Formula C to one side of their faces and the benzolyl peroxide comparator to the other side once daily for two weeks. Each subject is asked to record any side effects such as dryness, irritation, and perceived skin clarification. Both the Formula C and the comparator demonstrate similar skin clarification. Subjects report less irritation and improved skin condition on the Formula C treated side relative to comparator. [0061] Various modifications of the present invention, in addition to those shown and described herein, will be apparent to those skilled in the art of the above description. Such modifications are also intended to fall within the scope of the appended claims. [0062] Patents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These patents and publications are incorporated herein by reference to the same extent as if each individual application or publication was specifically and individually incorporated herein by reference. [0063] The foregoing description is illustrative of particular embodiments of the invention, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the invention.

1a

BACKGROUND OF THE INVENTION This invention relates to an improved apparatus for preparing a popped corn snack food popularly call "kettle corn." Frontiersmen and early settlers prepared popped corn in iron kettles placed over open wood fires. Later, such crude equipment and methods were modified by popped corn vendors who mounted kettle-like popping receptacles upon wagons and carts for movement along city streets and sidewalks. Descriptions of the structural and operational features of early portable poppers are contained in these prior U.S. Patents: ______________________________________1,449,687 Marfisi March 27, 19231,457,854 Parks June 05, 19231,464,567 French August 14, 19231,594,190 Barnard July 27, 1926______________________________________ Typically, these popper structures comprised a wheeled cabinet upon which were mounted a tiltable corn popping kettle, a popped corn storage receptacle proximate the kettle, and a fuel burner disposed below the kettle. Commonly, such burners were fueled with pressurized gasoline or kerosene vapor; however, later poppers having similar structural arrangements were provided with electric heater units such as that shown in U.S. Pat. No. 2,117,872 issued to Barnard on May 17, 1938. In more recent times, the carts of street vendors of popped corn have been replaced by sophisticated, highly efficient popping machines commonly encountered in theater lobbies, snack bars and fast-food stores. Moreover, consumers can now purchase sealed packages of popped corn in a variety of flavors; and, corn kernels can be popped at home by means of microwave ovens or specialized hot air appliances. In spite of these dramatic changes in methods and means for popping corn, a vestige of "old time" corn popping has been preserved through the years by certain vendors who pop corn in large metal kettles over an open flame. Such vendors tout their kettle corn as having a special flavor and texture imparted to the popped corn by preparing it in accordance with "old time" methods in an outdoor setting where freshly popped corn is immediately sold and consumed. Today, kettle corn vendors can be found at outdoor events such as pioneer festivals, community commemorative events, fairs, markets, exhibitions of antiquated crafts, and a variety of outdoor sports events. Vendors who reproduce the original kettle corn flavor and demonstrate faithfully pioneer kettle popping procedures use a kettle much larger than those disclosed in the aforecited U.S. Patents in order to retain exploding kernels within a kettle which typically has no lid or similar top closure. Moreover, it is desirable that the kettle top remains open so that the appetizing aroma and characteristic sound of popping corn can better escape the kettle to entice potential customers. A sizeable, open top kettle also enables a vendor to pop large batches of corn while continuously monitoring the popping process and agitating the mass of popping kernels with a rustic pole or paddle which carries out a back-country theme. Due to the considerable size of a preferred popping kettle and the common use of iron and steel to fabricate such kettles, their bulk and weight make them inherently difficult to transport from place to place and to support vertically above a heat source. Besides the problems encountered in transporting and positioning heavy kettles, emptying a hot kettle of a mass of popped corn can be an arduous task. To forestall overcooking or burning of popped kernels, the preparer had to empty the kettle quickly by scooping the kernels over the edge of the kettle into another receptacle all the while avoiding personal contact with the heat source under the kettle and the hot surface of the kettle itself. Heretofore the aforenoted multiple problems of transporting, supporting and emptying a weighty old-style popping kettle have been somewhat alleviated by situating the bowl-like kettle inside a box-like cabinet with the top of the kettle opening upwardly through the top of the cabinet. The kettle is attached to and suspended from the top of the cabinet with the kettle bottom hanging above a fuel burner mounted inside the cabinet. The cabinet top is manually pivotable about one edge in a manner which permits the preparer to dump the contents of the kettle into a suitable receptacle disposed outside the cabinet. Normally, a frame defining the bottom of the cabinet rested directly upon an underlying ground surface. The cabinet was movable from one popping site to another by lifting both the cabinet and the kettle contained therein and transporting them manually or by means of a hand truck, or the like, inserted under the bottom edge of the cabinet. Handling the aggregate weight and bulk of the cabinet and kettle by such a lifting and moving operation comprised a laborious task particularly over uneven or sloping surfaces. Another problem entailed in popping large quantities of popcorn in a large kettle over an open flame involves management not only of the flame, but also of the substantial volume of combustion products and heated air created by burning a sufficient quantity of fuel to achieve and maintain the required popping temperature of about 400° F. for a prolonged period of time. Most of the abovecited prior U.S. patents depict open flame poppers supported on various cabinet structures from which flame and hot gases created inside the cabinets are vented upwardly through the open cabinet top about the upstanding sidewall of the popping kettle. Contemporary kettle corn poppers also involve such venting of flame and gas directly through the open top of the box-like cabinet which suspends the kettle over the flame. This upward flow of hot gases produces unwanted heating of the upper wall portion of the kettle as well as the cabinet structure surrounding and supporting the top of the kettle. Unless great care is taken, such flow of hot gas about the periphery of the kettle during popping may cause injury to the vendor as he attempts to stir the kernels in the kettle to assure even and complete popping. Should the popping kettle be situated inside a tent or similar structure or shaded by an awning, uncontrolled upward venting of hot gases could create a fire hazard. Another significant shortcoming of previously known kettle poppers is the lack of an efficient means for handling a large mass of popped corn. After popping is completed, the popped corn is dumped from the hot kettle by tipping the top frame of the cabinet together with the kettle which is usually secured to this frame. Such manual tipping of the hot kettle can be difficult and dangerous; therefore, various auxiliary devices, including components such as gears and counterbalancing springs, have been incorporated in contemporary kettle poppers to assist the preparer in tipping the kettle. Such devices have proven to be cumbersome, complicated, and largely ineffective. Since a popping kettle is capable of producing very large individual batches of popped corn and since multiple batches are often prepared in rapid succession to accommodate a rush of customers, a large receptacle able to hold several batches is usually placed proximate the popping kettle. Popped corn is then manually scooped from this holding receptacle and bagged as needed. Usually, the holding receptacle, which may comprise a second metal vessel is not structurally associated with the frame which supports the kettle but is, instead, placed directly on the ground or on another stand at one side of the kettle. Since the holding vessel is not coupled directly to the kettle frame, it is subject to accidental dumping or shifting out of alignment with a stream of popped corn as it empties from the kettle. The foregoing recitation of the shortcomings of kettle-type corn popping components and methods suggests that several changes in popper construction and organization are needed to provide a comprehensive apparatus which exhibits the operational convenience and efficiency required by those whose business is preparing and vending kettle corn, namely: The popping kettle and its supporting frame or cabinet should be readily movable from place to place yet be highly stable once moved. The upward emission of flame and hot gases from the popper should be contained and directed so as to reduce or eliminate the chance of injury to vendors conducting the popping operation, to customers who approach the popper cabinet, and to combustible materials disposed proximate the popper cabinet. After a batch of corn is popped, the kettle should be conveniently tiltable over an edge of the popper cabinet in a quick and easy manner to dump successively popped batches into a suitable vessel. The vessel for receiving and holding popped corn dumped from the popping kettle should have a volume substantially greater than the kettle; and, the vessel should be detachably coupled to the frame of the cabinet at the correct height and angular alignment with respect to the kettle for receipt of the kettle contents. SUMMARY OF THE INVENTION A general object of this invention is to provide a corn popping apparatus for preparing kettle corn which overcomes the aforementioned shortcomings of prior art devices now employed for this purpose. A primary object of this invention is to combine structurally a large popping kettle, a kettle-supporting cabinet and a popped corn receiving-holding vessel to achieve these important advantages: Provision of substantial degree of mobility for such a relatively heavy structural combination; Provision of an improved process and means for producing and vending large quantities of freshly prepared popcorn; and, Reduction to a minimum of the hazards and discomfort unavoidably attending the preparation of popped corn over an open flame. With the above objects in view this invention is embodied in an improved cabinet structure having a hinged lid which carries the popping kettle. The cabinet comprises an assemblage of elongated metal members which are joined together to form an open, box-like framework. The vertical side frames are covered with metal panels, the top frame is partially closed by a centrally apertured panel. The lid is hinged at one edge to the top horizontal edge of one of the side frames. Between the panels covering the top frame and the lid frame, an air space or chamber is defined when the lid frame rests upon the underlying top frame. The axially aligned apertures opening through the top panel and the lid panel are circular and are sized to receive the circular kettle bottom so that the portion of the kettle which depends through the top panel and the lid into the cabinet interior is substantially greater than the remaining kettle portion which projects vertically above the lid panel. The lid panel and the kettle exterior wall are welded together about their circular line of contact; and, the aperture in the top panel through which the kettle passes is sized to fit closely about the kettle exterior. Pivotal movement of the lid about its hinged edge with respect to the top frame of the stationary cabinet withdraws the kettle bottom through the aperture in the top wall closure panel and causes the kettle to swing upwardly in an arc over and beyond the hinged edge of the cabinet causing a gravity-induced flow of the kettle's contents into a suitable receptacle or vessel. In accordance with another objective of this invention, the horizontal bottom members of two opposed side frames of the cabinet extend horizontally outwardly well beyond the side frame to which the lid is hinged. These bottom members pivotably support therebetween a wheel-mounting frame which is selectively swingable between opposed angular positions. An axle secured between the sides of the wheel mounting frame carries wheels which are lowered for engagement with the ground in one extreme angular position of the mounting frame and are lifted off the ground when the frame is moved to its opposed extreme angular position. When the wheels are in the lifted condition, the extended side frame bottom members rest on the ground. A second pair of wheels carried by an axle attached between the aforesaid bottom members extend through the open bottom frame of the cabinet for rolling contact with the ground surface underlying the cabinet. It will be appreciated that all four wheels engage the ground in the lowered position of the wheel mounting frame to facilitate movement of the kettle-cabinet-holding vessel combination; and, that, in the raised position of the wheel-mounting frame, the extended side frame bottom members rest directly upon the ground surface and serve to stabilize the popper apparatus. Another aspect of this invention is the provision of improved means for detachably mounting a popped corn receiving and holding vessel to that side of the cabinet over which the popping kettle is tipped for dumping. To this end, the vessel is suspended off the ground at a convenient height by a curved, circular bracket which underlies and engages the peripheral rim of the vessel. The bracket includes elongated tubular receivers into which are insertable a pair of elongated shafts projecting toward the vessel from the cabinet side frame proximate the vessel. The telescoping engagement of the tubular receivers about the elongated shafts maintains the plane of the circular bracket perpendicular to the proximate upright side of the cabinet and holds the vessel bottom in vertically spaced relation with the underlying wheel-mounting frame. The vessel and its supporting bracket are easily detached from the cabinet for cleaning or transporting simply by slidably withdrawing the bracket receivers from the shafts projecting from the cabinet. A further object is to provide an improved cabinet for housing and venting a burner which heats that portion of the surface of the popping kettle which depends downwardly from the lid panel through the subjacent top panel and into the cabinet interior. To this end, the cabinet is open at its bottom to admit combustion air for the burner, the aperture through the cabinet top panel is substantially sealed by the interfitting kettle bottom, and combustion products and heated air are vented through selected side panels of the cabinet except for those brief intervals when the kettle is tipped upwardly for dumping. Not only do the cabinet top panel and the lid panel coact to block most of the undesirable upward venting of hot gas from the cabinet top, but the aforedescribed air space defined by and between these panels provides a useful degree of thermal insulation between the heated cabinet interior and area above and around the cabinet top where the preparer is required to work. Yet another object is to provide a counterbalancing mechanism between the cabinet and the lid which enables the preparer to tilt the kettle for dumping its contents very quickly and with little physical effort. A still further object is to provide an improved corn popping apparatus having the aforesaid characteristics which is practical and efficient in its use and operation, which is of simple yet rugged construction, and which can be manufactured at low cost. These and other objects and advantageous features of the invention will become apparent and the invention will be best understood and fully appreciated by having reference to the following detailed description of a preferred embodiment of the invention taken in conjunction with the accompanying drawings. DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevation of an improved corn popping apparatus with a portion of the cabinet side panel broken away; FIG. 2 is a top plan view with various panels broken away to show interior details of the apparatus; FIG. 3 is a section taken along lines 3--3 of FIG. 2; FIG. 4 is a section taken along lines 4--4 of FIG. 2; FIG. 5 is a partial side elevation; FIG. 6 is a fragmentary view of a wheel-mounting frame; FIG. 7 is a section taken generally along lines 7--7 of FIG. 1; and, FIG. 8 is a partial sectional view taken along lines 8--8 of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION Referring FIGS. 1 and 2 of the drawings, the illustrative popping apparatus includes a generally cubic cabinet 10 to a top edge of which is attached a tiltable lid 12 penetrated by the bottom portion of a sizeable corn popping kettle 14. A bracket 16 is mounted on the cabinet and supports a large holding vessel 18 proximate the front wall of the cabinet. Two sets of ground engaging wheels 20 and 22 are attached to the bottom of the cabinet 10 to facilitate movement of the apparatus from place to place. A fuel burner 24 is housed within the cabinet below the kettle 14 for heating corn kernels to popping temperature. The cabinet 10 includes an open, box-like structure made up of upright, generally square metal frames 26 and 28 which provide the right hand side and left hand side, respective, of the cabinet as viewed in FIG. 2, and similar frames 30 and 32 which provide the front side and rear side, respectively, as viewed in FIG. 1. Preferably, the frames 26, 28, 30, 32 are fabricated by welding together tubular steel members having a square cross section. For example, and as best shown in FIG. 1, the top and bottom horizontal members 26a, 26b, respectively, of side frame 26 are welded to the front and rear vertical members 26c, 26d of this frame. The other cabinet frames referred to hereinafter are similar in structure; and, the method of assembling the basic cabinet framework will be obvious to those acquainted with metal fabrication. Each of the upright frames 26, 28, 30, 32 is covered by a steel sheet or panel welded to the vertical and horizontal tubular members defining each frame. FIG. 1 shows the right hand panel 34, FIG. 5 depicts a major fragment of the left hand panel 36, and FIGS. 3 and 4 show small fragments of the front panel 38. The rear frame 32 is covered by a similar panel, not shown, to complete the vertical enclosure of the space inside cabinet 10. The bottom of the cabinet is open to admit combustion air to the fuel burner 24. The joined upper members of side frames 26, 28, 30, 32, of which members 26a, 28a, and 30a are shown in the drawings, define a top marginal frame for the cabinet 10. To the undersides of these marginal members is attached a transverse top panel 40 similar to vertical sidewall panels covering the sides of the cabinet. The lid 12 includes a frame 42 corresponding in size and shape to the aforedescribed frame defining the top of the cabinet; and, frame 42 is made up of side members 42a, 42b and front and rear members 42c, 42d. Overlying and attached to the upper surfaces of members 42a, 42b, 42c, 42d is a transverse lid panel 44 having a central aperture 46 through which extends the bottom portion of kettle 14. The kettle 14 and lid panel are welded together or otherwise attached at their circular line of contact so that the kettle may be tilted with the lid 12 and dumped in a manner to be described. The lid 12 is pivotally hinged to the cabinet 10 for upward tilting movement about an axis extending longitudinally through the front top frame member 42c. FIG. 3 shows one of two like metal strap hinges 48 which surround pivot member 42c and are fixed to the underlying front frame member 30a. The looped bodies 48a of the hinges are axially penetrated by member 42c; and, the spaced legs 48b of the hinges are welded to opposed surfaces of member 30a. The lid panel 44 is notched as shown at numeral 50 in FIGS. 2 and 3 to permit pivotal movement of the lid panel 44 relative to the fixed strap hinges 48. In FIG. 1 the lid 12 and kettle 14 are depicted in their lowered or popping position relative to the cabinet 10; and, in FIG. 2, the lowered or popping position is shown in phantom lines while the tilted or dumping position is shown in full lines. To manipulate the lid and kettle about pivot member 42c to dump or to lower the same, the preparer may grasp a C-shaped handle 52 attached to the rearward portion of the top surface of lid panel 44. To limit the forward pivotal movement of the lid 12 to the desired stop position shown in FIG. 1, a metallic lug 54 is welded to the upper surface of lid frame member 42c and projects through a slot 56 relieved medially in the forward margin of lid panel 44. As best illustrated in FIG. 4, forward tilting of lid 12 and kettle 14 is arrested by abutment of the stop lug 54 against the front cabinet frame member 30a. In this arrested position, the lower portion of kettle rim 14a is disposed over and within the open top of the vessel 18 thereby assuring that the kettle contents will be directed into vessel without spillage. As best seen in FIG. 1, a conventional propane gas burner 24 is mounted on a bracket 58 which extends upwardly from the center of an underlying crossmember 60 attached at its opposite ends to cabinet frame members 26b and 28b. A suitable burner control assembly 62 including a conventional gas supply valve and pilot light is mounted on the rear cabinet panel and is connected in line with the burner 24 and a propane tank, not shown. An essential feature of this invention is the provision of a central aperture 66 in the top wall panel 40 of the cabinet 10 which has a diameter selected to permit the kettle's bottom portion 14b just to pass through panel 40 while depending downwardly into the cabinet interior in close proximity with the burner 24 when lid frame 42 is lowered to rest on the cabinet top frame. By mounting the kettle so that its bottom 14b projects through the lid panel 44 and by additionally providing the cabinet 10 with a top wall panel 40 having an aperture that can be effectively blocked by the kettle bottom, the emission of hot gases upwardly from the cabinet top during the popping operation is substantially reduced, if not altogether eliminated. Not only do the lid panel 44 and the top wall cabinet panel 40 coact to provide a double barrier to direct discharge of hot gas from the cabinet top, but an essentially closed, flat chamber 68 is defined between these panels when the kettle is lowered for popping. The vertical extent of chamber 68 is shown in FIG. 3; and, from FIG. 2 it will be understood that a wall segment of kettle 14 defines the inner wall of this chamber while the cabinet top frame and the lid frame abut one another to form an essentially square outer wall for chamber 68. An unexpected benefit derived from the provision of chamber 68 is that this air-filled space functions as a thermal insulating barrier which somewhat reduces unwanted convective heating of the lid 42, the handle 52, the kettle segment extending upwardly through the lid panel 44, as well as the open space immediately above the cabinet. When the lid 12 is tipped to dump popped corn into vessel 18, the control 62 may be operated to reduce the heat output of the burner 24. In any event, when the central aperture 66 through the top panel 40 is open, the remainder of panel 40 partially abets the rush of hot gas from the open cabinet top. It is intended that the cabinet interior be vented at all times by means of suitable openings through one or more of the aforedescribed upright cabinet wall panels. For example, FIG. 1 shows that an upper corner of panel 34 has been removed and a protective screen put in place over the triangular opening; and, FIG. 5 depicts an array of circular openings 72 through wall panel 36. In accordance with one object of this invention, a substantial degree of mobility is afforded the relatively heavy and bulky corn popping apparatus by means of rear and front wheels 20, 22. The rear wheels 20 are conventionally mounted on a rear axle 74 attached between the cabinet side frame bottom members 26b, 28b whereby the wheels 20 project downwardly through and beyond the bottom of the cabinet 10, as shown in FIG. 1. The side frame bottom members 26b, 28b project forwardly considerably beyond the cabinet side frame upright members 26c, 28c, respectively, as shown in FIGS. 1 and 5. A front axle 76 which carries the front wheels 22 is mounted on an oscillating frame 78 comprising spaced legs 80 which are connected by a cross member 82 and by the axle 76. Attached proximate the ends of the legs opposite the cross-member 82 are apertured blocks 84 which receive and retain the opposite ends of the axle 76. As shown in FIGS. 2 and 6, the frame 78 is rotatably attached between the cabinet side frame bottom members 26b, 28b by pins 86 extending laterally through the legs 80. In the wheel-lifting position of the frame 78, shown in full lines in FIG. 1 and also shown in FIG. 6, the blocks 84 project upwardly from the frame legs 80 thereby raising the axle sufficiently to support the wheels 22 out of engagement with any underlying surface upon which the rear cabinet wheels 20 rest. With wheels 22 so raised, the front end of the members 26b, 28b will be tilted downwardly slightly by the cabinet's weight into stabilizing engagement with the surface underlying the cabinet. To lower the wheels 22 for ground engagement, members 26b, 28b are lifted so that frame 78 can be rotated or pivoted counterclockwise, as viewed in FIG. 1, through 180 degrees to place the wheels in the lowered condition depicted by phantom lines. In this position of the frame 78, the ends of the legs 80 opposite the wheels 22 will bear against a pair of stop tabs 88 which limit counterclockwise frame rotation. The tabs are located and fixed to the underside of members 26b, 28b so that they do not interfere with subsequent reverse rotation of legs 80. To raise the wheels 22, the members 26b, 28b are lifted to permit clockwise rotation of frame 78 and the wheels to the position shown in full lines in FIGS. 1 and 5 wherein the members 26b, 28b will again rest on an underlying surface. In accordance with this invention, the large, pot-like vessel 18 has a volumetric capacity great enough for holding several batches of popped corn dumped thereinto from the popping kettle 14. The vessel is preferably fabricated from a malleable metal such as copper and its size gives it substantial weight The vessel 18 is mounted directly upon cabinet 10 to provide the advantages of easy transportation of the vessel with the wheeled cabinet, stable support of the curved-bottom vessel off the ground, and vertical support for the vessel at an elevated height whereby manual scooping of popped corn from the vessel for bagging becomes more convenient and less tiresome. To this end, vessel 18 is suspended by a circular collar or bracket 16 which underlies and engages the vessel rim 90. FIG. 8 shows that the rim 90 is somewhat enlarged and has been shaped to project radially outwardly from the vessel wall 92. The bracket 16 is rectangular in cross section and is thin enough to permit the bracket to underly the rim 90 and to flex somewhat to conform to any irregularities in the vessel wall. As shown in FIG. 2 angularly opposed portions of the bracket 16 are connected to tubular receivers 94. The forward projection ends 94a of the elongated hollow receivers 94 are appropriately shaped to conform to the vertical wall of the bracket thereby facilitating attachment of the receivers to the bracket by welding or a similar process. As best illustrated in FIG. 7 an elongated cylindrical shaft 96 is rigidly fixed to the upright right side frame member 26c. An identical shaft, not shown, is similarly attached to the upright left side frame member 28c. The shafts 96 project in a cantilevered fashion forwardly from the members 26c and 28c and closely fit with the interior cylindrical wall 94b of the receivers 94. When shafts 96 are fully inserted into the receivers, the extreme rear end surfaces of the receivers abut the members 26c and 28c and the distal ends 96a of the shafts are situated proximate the points of attachment of the receiver ends 94a to the bracket 16. Such substantial telescopic engagement of the shafts 96 and receivers 94 rigidly supports the bracket 16 in vertically spaced relation with the underlying wheel-mounting frame 78. While ruggedly constructed receivers 94 and shafts 96 coact to support the substantial weight of the vessel 18, it will be understood that the bracket 16 can be readily removed from the cabinet 10, with or without the vessel in place, by sliding the receivers horizontally forwardly from the shafts. The ease of assembly and disassembly of the bracket 16 from the cabinet 10 facilitates removal of the vessel as desired for cleaning, transporting and storing the same. To enable an operator of the hereindisclosed corn popping apparatus to tilt the kettle 14 for rapidly emptying its contents into vessel 18 thereby reducing the time that hot gas or flame may escape through the top panel opening 46 and, accordingly, reducing the exposure of the operator and customers near the apparatus to injury or discomfort, a counterbalancing device, indicated in its entirety by numeral 98, is attached between the cabinet side frame member 28b and the lid member 42c which, as noted above, pivots within the hinges 48 as the lid is raised and lowered. The device 98 includes a short rod 100 having a threaded end 102 extending through the opening of a nut 104 that is rigidly fixed to the laterally projecting extension 106 of the lid member 42c. The opposite end 108 of rod 100 is transversely penetrated by a pin 110 which, in turn, penetrates the spaced arms of a clevis 112. A rod 114 rigidly attached to the clevis at its upper end 116 has its lower end 118 threaded through a nut 120 fixed to the upper end coil of an elongated tension spring 122. The opposed end coil of this spring is anchored to a tab 124 extending outwardly from the left side frame bottom member 28b. The purpose of the spring 122 is to exert tension through the rod 114 and clevis 112 upon the forward end 108 of the rod 100. This tensile force acting on rod 100 creates a moment about the longitudinal axis of the lid pivot member 42c which counterbalances a substantial part of countervailing clockwise moment created by the combined weight of the lid 12 and the kettle 14. This counterbalancing effect can be adjusted to minimize operator effort required to tilt the lid for dumping while still permitting the lid to reseat completely upon the cabinet top frame when it is lowered. Such adjustment is achieved by changing the length of the forwardly projecting end 108 of the rod 100 and/or by changing the extent to which the 114 is threaded through the nut 120 whereby the spring tension is varied accordingly. The foregoing description of the embodiment of the invention shown in the drawings is illustrative and explanatory only; and, various changes in the size, shape and materials, as well as in specific details of the illustrated construction, may be made without departing from the scope of the invention. Therefore, I do not intend to be limited to the structure shown and described herein, but intend to cover all changes, modifications and substructures which are encompassed by the scope and spirit of the appended claims.

1a

RELATED APPLICATION [0001] The present application claims the benefit of provisional application 61/400,078, filed on Jul. 22, 2010. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention generally concerns cushions of the type that are specifically configured to alleviate discomfort in sitting, and in particular seat cushions used for the prevention, protection or alleviation either of pain, pressure or discomfort to the pelvic floor, perineum, coccyx and rectal region of the human body caused by sitting. [0004] 2. Description of the Prior Art [0005] Although symptoms of the above type may be centralized in the lower body, secondary sites in the upper body or extremities may be affected, with pain radiating from the original site of pain or discomfort. [0006] Developmentally, humans learn to sit upright at the age of approximately five months. Humans progressively gain motor control and core strength, enabling an upright position to be maintained while sitting on the body's weight bearing surfaces, the ischial tuberosities and greater trochanters. [0007] There is a well-documented need for seat cushions that perform at least one of the following functions. There is a need to pad or protect the user from pain or discomfort caused by either short or long periods of sitting on an un-padded, or insufficiently padded, surface. There is also a need to pad or protect the user from exacerbating pain or discomfort from an existing pathology or injury, such as childbirth, traumatic injury, surgery, etc. [0008] There is furthermore a need to lift the user off of the surface of a seat by redistributing weight and allowing the suspension of affected body parts above the seat. [0009] There is also a need to create an ergonomically correct seated position and posture for the user. [0010] A number of products are known that have attempted to address these needs for protection or alignment correction. [0011] Among these is the well known “donut” foam seat cushion, which is cylindrical with a hollow core for pressure relief, so named because it is in the shape of a donut with a hole in the middle. The donut foam cushion is large and is made of relatively dense material. The donut cushion, as one of few options that are available to users, has not received complete acceptance, due to its cumbersome size, the obviousness of its use (some users would prefer a cushion that is not so noticeable when in use), and issues with comfort. Examples of such cushions are disclosed in U.S. Pat. Nos. 5,079,785 and 5,046,205 and 5,288,132. [0012] While the donut cushion does promote pressure relief due to the hollow core, it may cause a pressure build-up as a result of the user's weight displacement into the center of the circle. The vascular supply to the perineum may be altered secondary to the increase in pressure around the ring from the user's weight being subject to natural gravitational forces, so as to displace the tissue down into the central opening. [0013] A U-shaped cushion with a thermal transfer unit is described in U.S. Pat. No. 7,344,196. [0014] Another commercially available product is the so-called “Tush Cush,” described in U.S. Pat. No. 4,840,425 which is a padded seat cushion in the shape of a square, having a small central opening in order to decrease pressure on the coccyx. The cushion itself is not adjustable, and the limited size of the opening may decrease pressure only for users who fall within a relatively limited range of weights and body types. Moreover, this cushion is large and bulky, and does not address pressure relief in the perineum. SUMMARY OF THE INVENTION [0015] It is an object of the present invention to provide a seat cushion that addresses the above issues in a unique and more effective manner than currently available cushions. [0016] This object is achieved in accordance with the present invention by a cushion adapted for human sitting, that is formed by two padded members or “wings” that are joined together at one end of each wing, so as to form a V-shape. The wings are joined together by a connection that allows the internal angle of the V-shape to be selectively adjusted. For storage or portability, the wings can be brought to a closed position directly adjacent to each other, wherein the angle is essentially 0 degrees. [0017] The V-cushion assembly is small, portable, lightweight and can be discretely used, making it ideal for use in the workplace, at sporting events, and concerts. The V-cushion assembly may also be beneficial for use while driving, or in any application where long periods of sitting, especially on a hard surface, are required. [0018] Compared to existing products, the V-cushion assembly exhibits superior portability and a discreet size and shape, thereby making the V-cushion assembly much more amenable to frequent use in all types of environments. Because the V-cushion assembly is not cumbersome and is easily portable and can be discreetly used, users are more likely to make use of the V-cushion assembly in environments where the user may previously have had a reluctance to use currently available products. [0019] In general, the V-cushion assembly provides relief and prevention of discomfort and pain experienced by persons seeking relief from such issues related to sitting. The V-cushion assembly offers an alternative to costly or insufficient products available to persons who have a range and variety of issues with unsatisfactory existing products. The V-cushion assembly is portable and concealable when in use, and thus offers a discrete solution to the use of such a cushion in public. The V-cushion assembly is easily adjustable by the user to ensure a proper sitting position that reduces that particular user's pressure, discomfort and/or pain. The V-cushion assembly offers relief to persons who are required to sit for long periods of time, whether in a work or recreational environment, or who have a medical need for such relief. The wings of the V-cushion assembly can be made available in various heights, widths and lengths so as to provide a range of models that suit all body types and sizes. Even with the use of a “standard” model of the V-cushion assembly, having dimensions designed to accommodate the “average” person, the versatility and adjustability of the V-cushion assembly allows the user a significant degree of customization to configure the V-cushion assembly to provide each person with the most comfortable configuration that simultaneously maximizes relief and minimizes the introduction of new, or exacerbation of existing, pain or discomfort. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 is a top view of the V-cushion assembly in accordance with the present invention. [0021] FIG. 2 is a bottom view of the V-cushion assembly in accordance with the present invention. [0022] FIG. 3 is a top view of the V-cushion assembly according to the invention with different configurations of the wings. [0023] FIG. 4 is a top view of the V-cushion assembly according to the invention, placed on the seat of a common chair. [0024] FIG. 5 shows the V-cushion assembly in accordance with the invention placed on a flat surface while lying flat, and while being folded to stack the wings, and in a completely folded position. [0025] FIG. 6 shows a further embodiment of the V-cushion assembly in accordance with the present invention having rigid angle straps. [0026] FIG. 7 shows a further embodiment of the V-cushion assembly according to the present invention placed on the seat of a common chair, making use of both rigid angle straps and pliable security straps. [0027] FIG. 8 shows a detail of the construction of a wing member of the V-cushion assembly in accordance with the present invention. [0028] FIG. 9 shows a detail and application of the rigid angle strap. [0029] FIG. 10 shows a detail and application of the pliable security strap. [0030] FIG. 11 is a side view, showing a preferred use of the V-cushion assembly in accordance with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0031] FIG. 1 shows a top view of a V-cushion assembly in accordance with the invention. The V-cushion assembly has two wings W 1 and W 2 , that are joined together at a connecting point CP, at which a connector C is present. The connector C not only holds the wings W 1 and W 2 together to form a V-shape, but also functions as a hinge to allow the angle between the wings W 1 and W 2 to be selectively adjusted. [0032] As explained in more detail below, the V-cushion assembly shown in FIG. 1 is intended to be placed on a seat surface, on which a human user will be seated. FIG. 2 shows a bottom view of the V-cushion assembly, i.e., the portion of the V-cushion assembly that will be adjacent to the seating surface when the V-cushion assembly is in use. As shown in the embodiment of FIG. 2 , the wings W 1 and W 2 can optionally be provided with respective non-slip regions NSP 1 and NSP 2 . The non-slip regions NSP 1 and NSP 2 provide sufficient frictional engagement with the seating surface to prevent slippage or shifting of the V-cushion assembly when in use on such a seating surface. [0033] FIG. 3 shows how the V-cushion assembly can be selectively configured to provide different angles θ between the wings W 1 and W 2 . The left portion of FIG. 3 shows the wings W 1 and W 2 in a relatively wide open configuration, whereas the center portion of FIG. 3 shows the wings W 1 and W 2 in a still open, but more closed configuration, and the right portion of FIG. 3 shows the V-cushion assembly in a closed position, with the wings W 1 and W 2 being directly adjacent to each other. The right portion in FIG. 3 may be used, for example, for carrying the V-cushion assembly in a compact form. [0034] FIG. 4 is a top view showing how the V-cushion assembly can be placed on the seat of a common chair. The V-cushion assembly can be placed with the V-shape being open toward the back of the chair, as illustrated in the left portion of FIG. 4 , or with the V-shape being open toward the front of the chair, as shown in the right portion of FIG. 4 . Depending on the preferences and comfort of the user, either orientation may be appropriate. [0035] FIG. 5 shows how the connector allows further folding of the wings W 1 and W 2 of the V-cushion assembly, in addition to the above-described adjustability of the angle of the V-shape. As shown in the left illustration in FIG. 5 , the wings W 1 and W 2 can lie completely flat, when in the closed position described above in connection with the right illustration in FIG. 3 . As shown in the center illustration in FIG. 5 , the wings W 1 and W 2 can be folded out of the plane shown in the left illustration, into a completely folded configuration as shown in the right illustration in FIG. 5 . [0036] FIG. 6 shows different top views of an embodiment of the V-cushion assembly placed on a seat of a common chair, in the orientations described above in connection with FIG. 4 . The two left illustrations in FIG. 6 show an embodiment of the V-cushion assembly having a rigid angle strap AS, which is sufficiently rigid to maintain the selected angle of the V-cushion assembly that is made by the user, once the user has appropriately configured the wings W 1 and W 2 . The angle strap AS can be affixed in any appropriate manner to the wings W 1 and W 2 to maintain them at the selected angle. [0037] The two right illustrations in FIG. 6 show the combination of an angle strap and the further option of security straps SS The security straps SS secure the V-cushion assembly to the seat of the chair, and are attached to the exterior sides of the wings W 1 and W 2 . The security straps SS can proceed beneath the seating surface, and be connected together in any suitable manner, such as by a buckle, snaps, or a hook-and-loop fastener. Alternatively, a continuous security strap, that does not require a connector, can be used, that is sufficiently elastic to hold the V-cushion assembly in place on the seat. [0038] FIG. 7 shows a further embodiment in the left illustrations, using both the angle strap AS and the security straps SS. In this embodiment, the security straps proceed between the front and rear of the seating surface, as opposed to proceeding around the sides of the seating surface as in the embodiment of FIG. 6 . An embodiment showing the use of only the security straps SS, without the angle strap AS, is shown in FIG. 7 , wherein the security straps SS again proceed between the front and rear of the seating surface. [0039] FIG. 8 shows a detail of one of the wings, in a top view, a side view, and a perspective view. [0040] FIG. 9 schematically illustrates the embodiment of the V-cushion assembly with the angle strap AS in a top view and a bottom view. This embodiment also includes the non-slip regions described above. As can be seen, the angle strip AS can be attached at the bottom of the wings of the V-cushion assembly, so as not to be noticeable by a user seated on the V-cushion assembly. [0041] FIG. 10 schematically illustrates a top view and a bottom view of the V-cushion assembly in the embodiment employing the security straps SS, in place on a chair. As can be seen in the bottom view at the right of FIG. 10 , the security strap SS proceeds between the legs of the chair in an appropriate manner. [0042] Each wing can be constructed of a flat soft core, having a width in a range between approximately 2 and 8 inches, a length and a range between approximately 8 and 16 inches and a thickness in a range between approximately 0.125 and 2.225 inches. The wings can be provided in different models with different dimensions and different combinations of dimensions, so as to provide a range of V-cushions that accommodate all different body sizes and weights. The core material of each wing may be foam, gel, batting, or any suitable material that provides a sufficient and desirable degree of padding, protection and separation from the seating surface. The material may be flexible foam rubber, cut from sheets or poured in a suitable mold. Moreover, each wing may be formed as a multi-layer combination with any number of the aforementioned materials. Each wing is covered by a durable, washable, water resistant protective cover, which may be removed for cleaning, decorative enhancement or replacement. The cover may be held in place on the core material simply by a custom-fit, with the covering being provided with a slip or other type of opening therein in order to insert and remove the core material. Alternatively, the cover may be provided with a zipper, snaps, or other releasable closure at a location that does not come into contact, and thus cause discomfort to, a user of the V-cushion assembly. Another alternative is a vinyl cover. [0043] FIG. 11 schematically illustrates the V-cushion assembly in place on a chair, with a user seated on the V-cushion assembly on the chair. [0044] 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

RELATED APPLICATION [0001] This application claims priority to U.S. Provisional Patent Application Serial No. 60/245,722, filed Nov. 2, 2000, and entitled “Method and System for Modulation of Oscillating Signals to Enhance Bilogic Effects” TECHNICAL FIELD [0002] The present invention relates generally to medical procedures and, more particularly, to a method and system for enhancing the efficacy of an applied tissue stimulation signal. BACKGROUND OF THE INVENTION [0003] As one can readily ascertain from a simple Internet inquiry, utilizing tissue stimulation to effect healing is an area of medicine which has gained a tremendous amount of acceptance. One of the more researched areas of tissue stimulation, magnetic and electromagnetic therapy, has been measured and proven to be effective in a wide variety of applications. For example, magnetic therapy has been used to promote healing in musculoskeletal conditions including spinal fusion, fracture non-union, osteonecrosis, ligament and tendon injuries, osteoprosis, and many other conditions. Magnetic therapy has also been applied to the cardiovascular system to treat blood vessels, to stimulate tissue angiogenesis, and other applications are currently being developed. [0004] A widely employed form of tissue stimulation utilizes pulsed electromagnetic fields (PEMF). PEMF is generally a low-energy, time varying-magnetic field commonly produced by an electromagnetic transducer coil. The electromagnetic transducer coil is situated near an injured area such that pulsing the electromagnetic transducer coil produces a driving PEMF that penetrates the underlying tissue and promotes healing of the injured area. SUMMARY OF THE INVENTION [0005] While it is known and has been shown that magnetic field therapy positively affects healing processes, it is thought that the current levels of magnetic field therapy efficacy could be improved. For example, research has shown, that in a population of cells treated with PEMF therapy, only a portion of the cells in the population respond to the applied PEMF. It is believed that if the PEMF affected a greater portion of the cell population, the resultant healing processes would be more effective, i.e., the healing processes would proceed at a greater pace and encompass larger regions of tissue. In addition, increased efficacy of magnetic therapy would allow magnetic therapy devices to be engineered to take advantage of this new-found effectiveness through the use of smaller units that require less power. [0006] It has been theorized that one of the reasons for the lack of response is that receptors on the non-responding cell in a cell population are slightly out-of-tune with cells in the remaining cell population that do respond. Thus, if a precise field is being applied to a cell population, only the cells that are in tune with the precise field will receive the field and subsequently be stimulated. The out-of-tune cells will generally not be able to receive the field and, therefore, will not be stimulated. [0007] Therefore, there is a need for a method and system for determining and selectively modulating tissue stimulation signals capable of accomplishing a desired effect on selected tissue at a treatment site which is more efficient and more effective than current tissue stimulation signal techniques and technology. This desired effect could include either stimulation of tissue growth and healing such as would enhance fracture healing or angiogenesis. In some conditions, however, the treatment frequency might be adjusted to selectively produce tissue damage in order to dissolve a blood clot or obstructing tissue mass such as a tumor. [0008] Thus, in accordance with teachings of the present invention, a tissue stimulation signal method and system are provided to more efficiently and more effectively produce a desired effect (either tissue growth or destruction) at a treatment site than known tissue stimulation signal methods and systems. [0009] In one aspect, the present invention increases the efficacy of magnetic field therapy by providing a method for affecting selected tissue at a treatment site. This method includes determining at least one stimulation signal capable of affecting at least one characteristic of the selected tissue and selectively modulating at least one stimulation signal such that a desired effect on the selected tissue is achieved. Modulating the stimulation signal increases the treatment frequencies that are applied to the tissue and results in an increased number of tissue cells responding to the treatment. [0010] In another aspect, the present invention provides a method for enhancing the biologic effects of an applied signal. The method may include generating at least one stimulation signal capable of effecting a desired result on the selected tissue at a treatment site, tuning at least one stimulation signal relative to at least one characteristic of the treatment site and applying the stimulation signal to the selected tissue at the treatment site. [0011] In yet another aspect, the present invention provides a system for enhancing the biologic effects of signals applied to selected tissue at a treatment site including at least one signal generator capable of generating at least one stimulation signal configured to produce a desired effect on selected tissue at a treatment site, at least one modulator operably coupled to the signal generator and configured to selectively modulate at least one stimulation signal such that at least one stimulation signal correlates with at least one characteristic of the treatment site and at least one emitter, preferably coupled to at least one signal generator and at least one modulator, configured to apply at least one stimulation signal to the selected tissue at the treatment site. [0012] In another embodiment, the present invention provides a method for enhancing the biologic effects of an applied signal. The method preferably includes generating at least one stimulation signal capable of effecting a desired result on selected tissue at a treatment site. The method then preferably selectively modulates at least one stimulation signal such that a desired effect on the tissue site is achieved and subsequently applies the stimulation signal to the selected tissue. BRIEF DESCRIPTION OF THE DRAWINGS [0013] For a more complete understanding of the present invention, and the advantages thereof, reference is now made to the following written description taken in conjunction with the accompanying drawings, in which: [0014] [0014]FIG. 1 illustrates a flow chart for one method according to teachings of the present invention; [0015] [0015]FIG. 2 illustrates a block diagram of a system according to teachings of the present invention; [0016] [0016]FIGS. 3A and 3B illustrate a stimulation signal routine before and after frequency modulation and the Fourier transform associated with each according to one embodiment of the present invention; [0017] [0017]FIG. 4 illustrates a stimulation device configured for use on a shoulder according to teachings of the present invention; [0018] [0018]FIG. 5 illustrates a stimulation device configured for use on an arm according to teachings of the present invention; [0019] [0019]FIG. 6 illustrates a stimulation device configured for use around a leg or torso according to teachings of the present invention; and [0020] [0020]FIG. 7 illustrates a read-out unit that may be used for displaying and recording a user's operation of a system according to teachings of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0021] Preferred embodiments of the present invention and its advantages are best understood by referring to the FIGS. 1 - 7 of the drawings, like numerals being used for like and corresponding parts of the various drawings. [0022] [0022]FIG. 1 illustrates a flow chart indicating a method 100 of implementing a stimulation signal treatment routine capable of producing a desired effect on selected tissue at a treatment site. Method 100 begins with step 105 in which identification of the tissue to be treated is performed. This identification, or diagnosis, produces results such as a fractured bone, a tumor or growth, a blood clot, or another medical condition which may respond to stimulation signal therapy. [0023] One of the goals of step 105 is to determine and select which type of tissue should be stimulated in order to most effectively treat the condition. For example, in the case of a fractured bone, it may be determined that it would be most effective to stimulate red blood cells and blood flow in the area of the fracture in order to enhance the calcification of the extracellular matrix, which would increase fracture healing. In the case of an organ with marginal blood supply, tissue stimulation therapy may be applied to stimulate angiogenesis (the formation of new blood vessels) in a previously ischemic area. [0024] In the case of a blood clot, it may be determined that the most effective treatment is to use a stimulation treatment frequency that would stimulate the clot itself such that it is broken up and the blood vessel is cleared of any obstruction to blood flow. Alternatively, it might be determined that stimulating red blood cells to increase the blood flow at the site of the clot will clear the blood vessel. Therefore, a stimulation signal capable of stimulating red blood cells to increase blood flow in the clotted area may be the selected treatment. [0025] In some cases it may be determined that stimulating certain cell or tissue types at a treatment site will be harmful to the desired outcome. In this situation, the use of certain stimulation signals should be avoided and those used should be ones which do not stimulate those particular cell and tissue types. [0026] Once the site to be treated has been identified, including the underlying components for which the treatment will be focused, e.g., red blood cells, bone tissue, or soft tissue, method 100 proceeds to step 110 where a determination of the type of stimulation signal which will most effectively produce the desired result is made. The present invention accommodates a myriad of possible factors which can influence the type of stimulation signal used to stimulate tissue at a treatment site. For example, it may be determined in accordance with teachings of the present invention that there is a relationship between the dimensions of a particular type of cell and the wavelength or frequency of an applied PEMF to which the cell will respond. In this scenario, the cell dimensions of the tissue to be treated would be determined and an appropriate PEMF would be generated and applied to the tissue. The stimulation signal is, in effect, tuned to the frequency which will be best received by the tissue under treatment. [0027] In addition to cell dimensions, other cell characteristics can be important in determining the most effective stimulation signal to be applied to a tissue type. For example, chemical compounds which make up or reside near the tissue can influence the type of stimulation signal which should be applied. Cell density and molecular dynamics, as well as other characteristics of a treatment site may have some bearing on what type of stimulation signal would be most effective for the treatment of the selected tissue at the treatment site. [0028] Once the appropriate characteristics of the tissue to be treated have been determined, it can then be determined whether application of an electrical stimulation signal or a mechanical stimulation signal would be more effective in the treatment of the selected tissue. For example, consider a situation where an obstructing tissue mass needs to be broken down. If the density or other characteristics of the tissue mass indicate that an electrical stimulation signal would not effectively break the tissue down it might be desirable to use a mechanical stimulation signal, such as a sound wave, to treat the tissue mass. The mechanical stimulation signal could then be adjusted so that the resonant frequency of the tissue mass and the frequency of the mechanical stimulation signal were additive. This additive effect could then result in the over-stimulation and eventual breakdown of the tissue mass. For some applications, a combination of electrical stimulation signals and mechanical stimulation signals may be used in accordance with teachings of the present invention. [0029] In determining the most effective stimulation signal, it may be desirable to treat more than one tissue type at a time. This will require determining a preferred stimulation signal for each tissue. For example, if it would be more effective to dissolve a blood clot by increasing blood flow and breaking up the clotting tissue, it may be determined that a sound wave stimulation signal tuned to break up the clotting tissue and a PEMF stimulation signal tuned to increase blood flow need to be simultaneously applied. [0030] Once the most effective stimulation signal or series of signals have been determined, method 100 proceeds to step 115 at which a stimulation signal treatment plan is devised. At step 115 , the most effective means of achieving the desired results on the selected tissue is further analyzed. [0031] The most effective stimulation signal therapy routine can involve many different factors. For example, if a portion of a cell population is showing no response to an applied PEMF, it may be determined that part of the population is out of tune with the PEMF and that is why it is not responding. One method of improving the response at this point would be to tune the applied PEMF such that a larger portion of the population exhibits a response to a given frequency of stimulation. [0032] An alternate method involves modulating the PEMF, such as by Frequency Modulation (FM) or Amplitude Modulation (AM), to effectively spread out the PEMF stimulation signal and increase the range of frequencies simultaneously applied to the tissue. This technique subsequently enables the PEMF stimulation signal to reach, be received by, and, therefore, stimulate a greater portion of the cell population. [0033] In the situation where multiple stimulation signals are needed to treat a selected tissue site, it is in step 115 where the output routine of the stimulation signals is determined. For example, it may be decided for reasons of device or treatment efficiency that the best way for the multiple stimulation signals to be applied to the tissue site is to overlap the signals such that a first stimulation signal is applied, and at the same time a second signal is applied, and so on, up to as many signals as are necessary for an effective treatment. An alternative to this overlapping, or parallel application, of multiple stimulation signals is to transmit each of the signals serially. For example, a first signal may be transmitted for a time period, turned off and then a second stimulation signal is transmitted and then turned off. This procedure can be repeated with as many stimulation signals as are necessary for an effective treatment. The sequence can then be begun all over again starting with the first signal. Other methods of serially applying stimulation signals are considered within the scope of the present invention. [0034] Upon determination of an appropriate stimulation signal routine, method 100 proceeds to step 120 . In step 120 , the stimulation signal routine is applied to the selected tissue at the treatment site. This application can take place using non-invasive devices such as those illustrated in FIGS. 4 - 7 , discussed below, or by using devices configured to be implanted internally at or near the treatment site of the subject being treated. [0035] To ensure the stimulation signal routine is effective, one embodiment of method 100 includes step 125 which involves monitoring the stimulation signal routine. Monitoring of the stimulation signal routine includes, but is not limited to, monitoring the effects on the selected tissue under treatment, monitoring the amount of time the stimulation signal therapy is applied, monitoring the consistency of the applied stimulation signal routine, as well as other characteristics. [0036] One possible goal of the monitoring performed in step 125 is to provide a reference for the evaluation of the stimulation signal and the stimulation signal routine to ensure that the stimulation signal and the stimulation signal routine are producing the desired effects on the selected tissue at the treatment site. For example, if the monitoring results indicate that the stimulation signal routine has been applied as planned but laboratory and radiologic tests indicate that the selected tissue is not responding, the frequency of stimulation signal being employed would be reevaluated at step 110 . If the stimulation signal in use is reaffirmed as the most effective, method 100 proceeds to step 115 for a stimulation signal routine reevaluation. Alternatively, if the monitoring results of step 125 determine that the stimulation signal routine is beginning to produce the desired results at the tissue site under treatment, method 100 returns to step 120 to continue application of the stimulation signal routine until the monitoring results are checked again. When it is determined that the results of step 125 indicate that the treatment of the selected tissue has been successful, method 100 ends stimulation signal therapy at 130 . [0037] [0037]FIG. 2 illustrates a block diagram of one embodiment of a system capable of performing method 100 of FIG. 1. System 200 includes tissue analysis module 205 to enable the identification of the tissue site to be treated. Components that might be included in tissue analysis module 205 include X-ray machines, blood analyzers, chemical detection means, as well as other components for evaluating biologic effects at a treatment site. Stimulation signal selection module 210 is included in tissue analysis module 205 to allow an appropriate stimulation signal to be quickly determined. Stimulation signal module 210 might include a database consisting of scientific data supporting which type of stimulation signal is most effective on certain types of tissues, chemical compounds, cell sizes, etc. Stimulation signal module 210 might also contain simulations of the effects of various stimulation signal types on various tissue types to enable the selection of the appropriate stimulation signal for producing a desired result. [0038] Operably coupled to tissue analysis module 205 is stimulation signal module 215 . Stimulation signal module 215 includes at least one signal generator 220 capable of generating the stimulation signal determined to be appropriate by tissue analysis module 205 . Signal generator 220 , in a preferred embodiment, is capable of producing various waveforms with various duty cycles, amplitudes, frequencies, as well as other signal characteristics. In addition, signal generator 220 is configured with a tuning capability. Stimulation signal module 215 also includes at least one modulator 225 capable of selectively modulating the signals generated by signal generator 220 . Various forms of modulation are anticipated, including, but not limited to, Frequency Modulation (FM), Amplitude Modulation (AM), duty cycle modulation, as well as variants thereof. Emitter 230 is included to enable the stimulation signal generated to be applied to the selected tissue at the treatment site. [0039] Stimulation signal module 215 is preferably coupled to monitoring module 235 . Monitoring module 235 might include memory, such as random access memory, magnetic media, as well as others, to record the stimulation signal routine being emitted by stimulation signal module 215 . [0040] Exemplary embodiments of the tissue site therapy system of the present invention are configured to provide stimulation signals, in the form of PEMFs, sound waves, or other forms of electromagnetic energy or heat energy. The treatment sites may include the shoulder, the hands, the hip, blood vessels, the heart, tumors or essentially any other anatomic region to assist in the healing of injuries or the treatment of ailments. [0041] [0041]FIGS. 3A and 3B illustrate a stimulation signal routine before and after frequency modulation and the Fourier transform associated with each according to one embodiment of the present invention. Specifically, in FIG. 3A, a sinusoidal stimulation signal routine 315 is illustrated in the time domain at 305 and in the frequency domain 310 . Sinusoidal stimulation signal routine 315 is oscillating at center frequency fc. As illustrated at 320 , the power carried by sinusoidal stimulation signal routine 315 is centralized primarily at center frequency fc. Thus, unmodulated stimulation signal routines typically provide the majority of their power primarily at their center frequency or oscillating frequency, as illustrated at 310 . [0042] According to teachings of the present invention, a lack of response in a portion of the cells at the treatment site is likely to be displayed because the receptors of the non-responsive cells are out of tune with center frequency fc of the applied stimulation signal. Thus, the precise field of an unmodulated stimulation signal routine will be received by that portion of the cells at the treatment site which are in tune with the precise field. Accordingly, only that portion receiving the precise field will be affected by the unmodulated stimulation signal routine. [0043] Illustrated at 323 in FIG. 3B, is the result of passing sinusoidal stimulation signal routine 315 of FIG. 3A through a frequency modulator. The resultant Fourier transform of frequency modulated stimulation signal routine 325 is illustrated at 330 . One significant result of frequency modulating sinusoidal stimulation signal routine 315 is that instead of being limited to the primary power frequency fc as indicated at 320 , the power in frequency modulated sinusoidal stimulation signal routine 325 is spread out over a broad range of frequencies. The result of this spreading of power is that a greater portion of the cells at the tissue site under treatment, will be effected. [0044] As mentioned above, since the cells at the tissue site under treatment are likely to be out of tune with a primary frequency, the spreading out of the power contained in a stimulation signal routine enables a greater portions of the cells to be effected. Subsequently, as illustrated at 330 , significant power can be observed not only at center frequency 333 , but also at harmonics 334 - 337 and sub-harmonics 338 - 341 of frequency modulated stimulation signal routine 325 . Additionally, although FIGS. 3A and 3B include a sinusoidal stimulation signal routine, stimulation signal routines of other forms, such as square, triangular, diamond and other, are also considered within the scope of the present invention. [0045] FIGS. 4 - 7 illustrate different examples of non-invasive stimulation therapy systems formed according to teachings of the present invention. The stimulation signal generators employed to effect the present invention may be formed and anatomically contoured for the shoulder, the wrist, the hip or other areas of the anatomy. FIG. 4, in particular, shows a contoured triangular stimulation signal transducer 410 that is anatomically contoured for providing stimulation therapy to the shoulder area. That is, one side is curved to fit over the top of the shoulder so that corresponding angular areas are positioned in front and in back of the shoulder, with the other sides being curved down along the upper arm. The shoulder transducer is an integral unit including drive electronics and control electronics that may be held in place by a body strap. [0046] [0046]FIG. 5 shows a placement of a stimulation therapy device that includes a stimulation transducer 512 according to the teachings of the present invention, but of a size and shape that best suits the patient's wrist or other limb portion. Stimulation transducer drive circuitry and control electronics are preferably included as an integral part of stimulation transducer 512 . [0047] [0047]FIG. 6 shows yet another embodiment of the present invention as a hip belt stimulation therapy device 618 that a patient may wear around the waist, the stimulation transducer 620 arranged over the hip area. The drive electronics and control circuitry, again, are an integral part of stimulation therapy device 618 . [0048] [0048]FIG. 7 shows a read-out unit 722 that may be used for displaying and recording a patient's operation of the present invention. The present invention may include, therefore, an extended memory and built-in printer interface 724 for providing the ability to correlate patient usage with desired healing progress and provide results on a paper print-out device 726 . The system of the present embodiment, for example, may store months of compliance data for developing important correlation data and print out such data using a paper print-out device 726 . [0049] Although the present invention and its advantages have been described in detail it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the invention as defined by the following claims.

1a

RELATED APPLICATIONS [0001] This is a §371 of International Application No. PCT/CL2011/000010, with an international filing date of Jan. 28, 2011 (WO 2011/094888 A1, published Aug. 11, 2011), which is based on Chilean Patent Application No. 099-2010, filed Feb. 4, 2010, the subject matter of which is incorporated by reference. TECHNICAL FIELD [0002] This disclosure relates to a viability detection method for plant cells, tissues and plants which does not cause damage in the plant sample under study, allowing its normal growth after being submitted to evaluation. The method disclosed is based on the determination of the activity of the alpha-amylase enzyme present in plant tissues. [0003] This disclosure also relates to a viability detection device and the suitable revealing system. BACKGROUND [0004] The development of in vitro plant culturing techniques permitted the creation of a biotechnological industry oriented to the production and commercialization of plants at a world level. One of the critical points in the development of this industry is the determination of the viability of the tissues with which one works, a determinant factor for methodological efficiencies and profitability of the production. On the other side, at the level of research studies, physiological and biotechnological studies, cell viability represents an important parameter associated to the response to biotic or abiotic stress, generation of genetically engineered plants among other uses. Viability has been an essential parameter in the assessment of adaptation to different types of stress, such as cold tolerance (Leborgne et al. 1995) and in responses to freezing, heat or high salinity (Ishikawa et al. 1995). [0005] The methods used for assessing viability of plant cells or tissue are mostly invasive and destructive, based on the irreversible staining of plant cells or tissues, without the possibility of recovering and reintroducing them into the productive system. On the other side, these methods are usually complex and costly for the plant producing industry. In general terms, the methods used for measuring viability may be classified in two groups: those that only stain dead cells and those that only color the living cells, in this latter case, the color is normally a product of metabolic activity (Widholm, 1972). The most used stains for dead cells are Evans blue, bromophenol blue, methylene blue and phenosafranin, whereas fluorescein diacetate (FDA) is used for living cells. [0006] Another viability evaluation method includes determination of enzymes such as reductases and esterases. Reductase activity is determined spectrometrically measuring the absorbance of formazan, which is a reduction product of 2,3,5-triphenyltetrazolium chloride (Towill and Mazur, 1974). The determination of esterase activity uses its ability for hydrolyzing the fluorogenic substrate fluorescein diacetate (FDA), which is widely used for viability detection both of animal and plant cells, this compound passes through the cell membrane and is converted into a fluorescent substrate, named fluorescein, by the endogenous esterase enzyme. In general, the use of FDA makes it possible to distinguish living cells from dead cells by fluorescence detection equipment (Yamori et al. 2006). [0007] For viability detection of whole plants, a colorimetric technology has been developed oriented to determine the stress-produced damage in fruit, vegetable, plant or flower, which is based on the difference in the production of volatile compounds like ethanol and aldehyde by plants upon suffering the damage. The method comprises covering the plant with an isolating cover and determining the change in the gases in the interior thereof, the gas detection method is of the colorimetric type, with reagents of the potassium dichromate type for determining volatile ethanol (U.S. Pat. No. 6,306,620). [0008] Over the last years and thanks to the increase in the capacity to measure weak light signals (Ntziachristos et al. 2005, Fujimoto et al. 2000, Watanabe et al. 2007), there has been developed a technology for determination of seed viability by retarded luminescence. It is considered that photons may be considered as information carriers due to their interaction at the atomic and molecular level, providing information regarding the chemical components and the complex structure of the systems (Costanzo et al. 2008). Even though the system allows to determine the viability of plant samples non invasively and with quite accurate results, a series of sophisticated pieces of equipment are required for performing the measurements and the analysis thereof. [0009] On the other side, for seed viability detection there exist some non destructive technologies based on bioelectric current. Each organism contains redox activity levels, and in plants, it has been established that bioelectric currents are associated with ion mobility. Redox activity can be used to monitor enzymatic activity levels and consequently seed viability. In the method designed, seeds are moistened to initiate the first phase of their pregermination cycle, and electric current is passed therethrough. Seed viability has been calibrated by correlating the radicular length with the electric current values measured in the corresponding seeds (U.S. Pat. No. 3,852,914). This method, although non invasive, requires special equipment to be able to perform the measurements and the analysis thereof. [0010] This disclosure possesses advantages over the subject matters described in the state of the art, since it allows to detect in a simple manner the viability of plant cells, tissues and whole plants without damaging the analyzed samples, allowing the subsequent growth and utilization thereof in a normal manner. On the other side, this disclosure provides trustworthy results without requiring sophisticated equipment for the implementation thereof or for interpretation of results. SUMMARY [0011] This disclosure relates to a viability detection method for plant cells, tissues and/or whole plants, based on the determination of the activity of the alpha-amylase released into the medium, the enzyme is indirectly detected by determining degraded starch in a culture medium supplemented with the carbohydrate. [0012] The method for determining the viability of a plant sample comprises the following steps: a) providing a viability detection device containing a solid or semisolid culture medium suitable for the nutritional requirements of a plant sample, wherein the culture medium has a starch supplement; b) growing the plant tissue in the viability detection device from the previous step; c) removing the plant tissue sample from the viability detection device; d) revealing the viability detection device. [0017] This disclosure comprises a viability detection kit for a plant sample, which comprises: a support, a culture medium, a starch supplement, and an iodine-based revealing composition, wherein the starch supplement is to be added to the culture medium in a concentration sufficient to achieve a starch concentration in the culture medium of between 0.5 and 5.0 gL −1 , and wherein the culture medium and the starch supplement are admixed to form a culture medium supplemented with starch. The support contains the culture medium supplemented with starch. The culture medium supplemented with starch has a starch concentration of between 0.5 and 5.0 gL −1 . [0018] This disclosure comprises a viability detection device for a plant sample, which comprises a support which contains a culture medium supplemented with starch in which the plant tissue is grown. [0019] The viability detection device comprises a support which comprises a plate, a flask, a Petri plate or an Eppendorf tube, with or without a lid. [0020] The present viability detection method does not destroy or damage plant tissues, allowing the normal growth of the plant after being submitted to viability detection analysis. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 shows standardization of the starch concentration in the culture medium for detection of plant viability. The photograph shows 4 plates with culture medium (MS basal medium+7 gL −1 of agar-agar+30 gL −1 of sucrose) supplemented with different starch concentrations, Plate A: 1.0 gL −1 ; B: 1.0 gL −1 , Plate C: 1.5 gL −1 , Plate D: 2.0 gL −1 . Explants of nodal segments of tobacco were cultured in the 4 plates for 72 hours at 25° C. in the dark. Subsequently, the explants were removed from plates B, C and D, and plates B, C and D were revealed with a 10% iodine solution. Plate A corresponds to controls of living explants which correspond to nodal segments of tobacco growing in MS+7 gL −1 of agar-agar+30 gL −1 of sucrose+starch at 1.0 gL −1 , which plate was not revealed. The arrows in plates B, C and D indicate some of the locations where the explants were seeded. [0022] FIG. 2 shows viability detection in living (A) and dead (B) rhizomes of the terrestrial orchid Chloraea crispa . The sign of viability in the living tissues (Plate A) is expressed in the formation of a colorless halo in the zone where the explants were cultured, an effect that is not produced in dead tissues (Plate B). The living and dead tissues were incubated in plates A and B during 72 hours in the dark, at rest and at a temperature of 25° C. After that time, the rhizomes were removed and the plates were treated with revealing solution. The arrows indicate the locations where the explants were seeded. [0023] FIG. 3 shows viability detection in different papaya tissues. Fig. A corresponds to detection of the viability of a nodal segment of papaya ( Carica vasconcellea ) cultured in MS basal medium+sucrose (30 gL −1 )+GA 3 (1.0 mgL −1 )+starch (1.0 gL −1 ) in triplicate. Fig. B corresponds to detection of the viability of papaya ( Carica vasconcellea ) leaves cultured in MS basal medium+sucrose (30 gL −1 )+GA 3 (1.0 mgL −1 )+starch (1.0 gL −1 ) in triplicate. All tissues were incubated in plates during 72 hours in the dark, at rest and at a temperature of 25° C. After that time, the nodal segments and the leaves from papaya were removed from the plates, and the plates were treated with revealing solution. The arrows indicate some of the locations where the explants were seeded. [0024] FIG. 4 shows viability detection in orchid meristems. The tissues were cultured in Van Waes Medium salts+sucrose (30 gL −1 )+TDZ (1.5 mgL −1 )+IBA (1.5 mgL −1 )+starch (1.0 gL −1 ) in triplicate. All tissues were incubated in the plates during 72 hours in the dark, at rest and at a temperature of 25° C. After that time, the meristems were removed, and the plates were treated with revealing solution. The arrow indicates one of the locations where the explants were seeded. [0025] FIG. 5 shows viability detection in nodal segments of tobacco ( Nicotiana tabacum ). The tissues were cultured in MS+sucrose (30 gL −1 )+6-benzylaminopurine (BAP) (0.1 mgL −1 )+starch (1.0 gL −1 ) in triplicate. All tissues were incubated in plates during 72 hours in the dark, at rest and at a temperature of 25° C. After that time, the nodal segments were removed and the plates were treated with revealing solution. The arrow indicates one of the locations where the explants were seeded. [0026] FIG. 6 shows the effect of starch on the morphogenic response of nodal segments cultured in propagation basal medium for 15 days. (A) shows nodal segments of tobacco cultured in culture medium without a carbon source. (B) shows nodal segments of tobacco cultured in culture medium supplemented with sucrose at 30 gL −1 as an energy source, and starch at 1.5 gL −1 . (C) shows nodal segments of tobacco cultured in culture medium supplemented only with starch at 1.5 gL −1 . DETAILED DESCRIPTION [0027] The method proposed is based on detection of the activity of the alpha-amylase enzyme released into the culture medium, as a way of determining the viability of any plant tissue. In general terms, the method is based on the ability of the alpha-amylase enzyme for degrading the starch present in the culture medium of the detection device where the plant sample is grown, the degradation is evidenced by the lack of color on the surface of the culture medium of the device, upon being revealed with an iodine-based solution. The alpha-amylase enzyme is mainly present in plant tissues, whereby the method has a level of selection toward the growth of other organisms, without prejudice to the foregoing. Preferably, the method is developed under conventional aseptic conditions of the state of the art. [0028] The alpha-amylase enzyme is present in all plant tissues and cells, and although it exhibits a different degree of presence and activity in the different tissues and stages of development of a plant, they are perfectly detectable through the proposed method. [0029] The method disclosed allows to determine viability in plant samples from different species of gymnosperm or angiosperm, monocotyledonous or dicotyledonous plants, from plants grown in vivo or cultured in vitro. On the other side, the present method allows to determine viability at different stages of development of the plant, for example, and not limited to organogenesis, callogenesis, somatic embryogenesis, differentiated tissues and sex tissues. The method for determining viability allows to determine viability in plant tissues from different parts of the plant, not limited to leaves, stems, petioles, calluses, embryos, protocorms, rhizomes or roots, in addition to polen and seeds. [0030] The method for determining viability as designed may be applied to any plant culture process which requires a viability detection step either with commercial, scientific research or other purposes, for example, and not limited to, micropropagation technology, viability in polen grains, viability of in vitro and ex vitro tissues submitted to biotic and abiotic stress, viability of tissues from genetically engineered plants, viability of ovaries, detection of the viability of any plant tissue and culturing in bioreactors. [0031] The culture medium is chosen from the state of the art according to the nutritional requirements typical of the plant tissue to be analyzed. The culture medium may be supplemented with compounds normally used in processes such as: culturing plant tissues; selecting transformed tissues; avoiding contamination of the medium with other prokaryotic or eukaryotic organisms; stimulating the morphogenic response of the tissues; ensuring the development and growth of the cells or tissues in the physiologic state in which the present viability detection method is developed, among others. The compounds with which the culture medium may be supplemented comprise, for example: inorganic salts, organic salts, minerals, vitamins, aminoacids, natural or synthetic growth regulators, agar or any other polymer used to solidify culture media, bactericides, fungicides; organic acids and inorganic acids and water. [0032] The culture medium is additionally supplemented with starch. Preferably, the starch concentration of the culture medium is between 0.5 and 5.0 gL −1 , preferably between 1.0 and 3.0 gL −1 , more preferably between 1.0 and 2.0 gL −1 . [0033] The revealing composition is based on iodine with a 10% iodine solution, the revealing composition may further contain preservatives, such as organic acids, antibiotics and fungicides. [0034] The device is manufactured under regular sterility and asepsis conditions described in the state of the art. The plant sample is treated considering the normal aseptic conditions described in the state of the art. [0035] In the method for determining viability, the plant samples are placed on the surface of the culture medium of the device and are incubated for a period of time and in temperature conditions suitable for each plant species. Preferably, the culturing of plant tissues is carried out in dark conditions since a greater starch uptake by the plant tissue is obtained. [0036] In step c) the tissue sample is removed from the culture medium. The analyzed plant sample may be subsequently subcultured in culture medium without starch or used according to the purposes deemed convenient by the user. [0037] In step d) for revealing the viability detection device, an iodine solution is poured onto the surface of the culture medium which is incubated for a period of time at room temperature. Preferably, this incubation lasts between 3 and 5 minutes and is conducted between 20 and 25° C. Subsequently, the iodine solution is removed from the surface and, as a positive viability result, a colorless halo is observed in the location where the plant sample was grown. This halo reflects the degradation of the starch present in the culture medium. Degradation of the starch by the enzymes of the plant is evidenced visually, thus detecting the viability of the assessed sample. If the tissue is alive, a colorless halo is observed underneath the place where the tissue was located. The halo may be of a variable size, depending on the type of tissue and the plant species, however, clear differences are observed between the color of the culture medium and the halo formed in the zone where the explant was cultured, when the tissue is viable. If the tissue is dead, the surface underneath the evaluated explant is stained with blue similar to the rest of the culture medium. EXAMPLES Example 1 Standardization of the Culture Medium for the Viability Detection Device [0038] To define the starch composition of the test culture medium to be used in the following experiments, tests were conducted with basic culture medium supplemented with different starch concentrations. In this experiment ( FIG. 1 ), nodal segments of tobacco ( Nicotiana tabacum ) were used as a model. [0039] The culture medium was prepared with MS basal medium (Murashige and Skoog, 1962) and agar-agar (7 gL −1 ), supplemented with sucrose (30 gL −1 ) and different amounts of starch (0.5 gL −1 , 1.0 gL −1 , 1.5 gL −1 , 2.0 gL −1 ). The pH of the culture medium was adjusted to 5.6-5.7, before sterilizing. Sterilization of the culture medium was performed by pressurized steam in an autoclave at a temperature of 121° C., a pressure of 1 kgcm −2 and for 30 minutes. Once sterile, the culture media were dispensed into viability detection devices such as Petri plates in aseptic conditions. [0040] The explants were taken from aseptic nodal segments of tobacco grown in vitro. The explants were prepared in segments of 0.5 cm in length and 0.5 cm in length. Once prepared, the explants were placed in the viability detection devices, trying to keep sufficient distance therebetween to avoid interferences in the signs of viability, preferably 5 explants per device. The explants were cultured for 1, 2, 3 and 5 days, at 25° C. and in dark conditions. After this incubation period, the explants were removed from the plates and the latter were revealed with an iodine solution as indicated in the following paragraph. [0041] Revealing of the plates was performed using an iodine solution diluted to 10%. The iodine solution diluted to 10% was prepared in two steps: firstly, a colorless solution of potassium iodide (KI) at 300 gL −1 was prepared. Subsequently, the KI solution was used to prepare the iodinated solution by adding 233.1 mL of KI solution and 56 g of iodine crystals to 500 ml of distilled water. The solution was stirred for 1 hour or until the crystals were completely dissolved and the solution was homogenized, and was left to stand for 24 hours. Finally, the volume of the solution was adjusted by adding 3.5 liters of distilled water. [0042] To visualize the signs of viability in the detection plates, a film of iodine solution diluted to 10% was applied for 3 minutes on the surface of the plates until staining was observed in the culture medium. Subsequently, the iodine solution was removed from the surface of the plates by runoff. [0043] FIG. 1 shows the results of the standardization of the culture medium in viability detection experiments on nodal segments of tobacco, in plates B, C and D, a colorless halo is observed on the surface where the implants were cultured, demonstrating the viability of the grown tissues. It was determined to use 1.5 gL −1 of starch in the culture medium as the preferred concentration for cell viability detection in this experimental model. Example 2 Viability Detection in Different Explants from Strawberry ( Fragaria chiloensis ), Tobacco ( Nicotiana tabacum ), Blueberries ( Vaccinum corymbosun ) and Andean Papaya ( Carica vasconcellea ) [0044] Viability tests were conducted on explants obtained from different plant species and different tissues thereof, using our viability detection device. [0045] The experimental steps for detecting the viability of the different tissues are described below: a) Preparation of the Viability Detection Plates: [0000] MS basal medium (Murashige and Skoog, 1962) was used, supplemented with 1.5 gL −1 of starch, 30 gL −1 of sucrose, 7 gL −1 of agar-agar and growth regulators according to the type of explant and the species, as indicated in Table 1. This working concentration was chosen according to the type of explant, the plant species and the morphogenic process in which the viability detection is performed. The basal salts and the vitamins of the MS medium were added according to the concentrations suggested for the preparation of this culture medium, without any modification (Murashige and Skoog, 1962). The pH of the culture medium was adjusted to 5.6-5.7, before sterilizing. Sterilization of the culture medium was performed by pressurized steam in an autoclave at a temperature of 121° C., a pressure of 1 kgcm −2 and for 30 minutes. Once sterile, the culture media were dispensed into Petri plates in aseptic conditions. The plates may be sealed and kept in the dark and at room temperature for up to 30 days before being used. [0000] TABLE 1 Composition of the culture media used in the viability tests on different explants and species. Species Explant Culture medium Tobacco Leaves, stems, MS salts + sucrose (30 gL −1 ) + 6-benzyl-aminopurine (BAP) (0.1 mgL −1 ) petioles, calluses Papaya Leaves, stems, MS salts + sucrose (30 gL −1 ) + gibberellic acid (GA 3 ) (1.0 mgL −1 ) petioles Calluses MS salts + sucrose (30 gL −1 ) + 2,4-dichloro-phenoxyacetic acid (2,4-D) (1.0 mgL −1 ) + thidiazuron (TDZ) (1.5 mgL −1 ) Strawberry Leaves, stems, MS salts + sucrose (30 gL −1 ) + indole-butyric acid (IBA) (1.0 mgL −1 ) petioles Calluses MS salts + sucrose (30 gL −1 ) + IBA (0.01 mgL −1 ) + TDZ (0.25 mgL −1 ) Blueberries Leaves, stems, Woody Plant Medium salts (McCown and Lloyd, 1991) + sucrose petioles, calluses (30 gL −1 ) + 2-iP (4.0 mgL −1 ). Orchids Leaves, rhizomes Van Waes Medium salts (van Waes and Debergh, 1986) + sucrose (30 gL −1 ) + TDZ (1.5 mgL −1 ) + IBA (1.5 mgL −1 ). Calluses, somatic Van Waes Medium salts (van Waes and Debergh, 1986) + sucrose embryos (30 gL 1 ) + BAP (0.2 mgL −1 ). b) Preparation of the Explants: [0000] All explants were taken from plants grown under in vitro conditions. The explants were prepared in segments of 0.5 cm in length and 0.5 cm in length in the case of the leaves; 0.5 cm in diameter for the calluses; 0.5 cm in length for the nodal segments and petioles. c) Culturing of the Explants in the Culture Plates and Viability Assay. [0000] Once prepared, the explants were placed in the viability detection plate, trying to keep sufficient distance therebetween to avoid interferences in the signs of viability. In this case, not more than 6 explants were placed in plates of 10 cm in diameter, without prejudice to other densities in the species and tissues that might permit them. All the explants were placed on the culture medium as if they were to be manipulated for generating morphogenic responses according to the indications of the protocols for each species. The explants were cultured in the viability detection plates from 24 hours to 5 days and were cultured at 25° C. and in dark conditions. The explants were removed from the viability detection medium for the subsequent revealing of the plates. The explants were subcultured in a culture medium recommended for each species to induce the desired morphogenic response. In this case, the basal culture medium described in Table 1 was used, but without the addition of starch. FIG. 6 shows that the culturing period in the viability detection medium did not affect the morphogenic response. [0053] Revealing of the viability detection plates was performed using an iodine solution diluted to 10%. This solution was prepared according to the protocol for the preparation of the iodine solution described in Example 1. [0054] To visualize the signs of viability in the detection plates, a film of iodine solution diluted to 10% was applied for 3 minutes on the surface of the plates until staining was observed in the culture medium. Subsequently, the iodine solution was removed from the surface of the plates by runoff. [0055] As a way of control, viability tests were carried out with samples of living and dead tissues. To this end, rhizomes of the terrestrial orchid Chloraea crispa cultured in vitro were used. The dead tissue samples were obtained by sterilizing them in an autoclave at 121° C. and 1 kgcm −2 for 40 minutes. FIG. 2 shows the results of the experiment, demonstrating that the detection system allows to clearly determine the viability of the tissue under study, since a colorless halo can be clearly observed on the surface of the plate where the living tissues were cultured ( FIG. 2A ), due to the degradation of the starch in this sector of the plate. The halos are not observed in the plates with dead tissues ( FIG. 2B ). [0056] FIGS. 3 , 4 and 5 show the results of the viability tests performed for some of the types of tissues described in Table 1. In these photographs, it can be confirmed that the system proposed allows to detect the activity of living tissues of different origins, both at the level of species and of tissue type, independent of the basal culture medium used. [0057] It should be mentioned that the tissues used in these tests are those commonly used in the in vitro multiplication protocols of most plant species. Example 3 Effect of Starch on the Growth of Plant Tissues [0058] To determine the possible effect of starch on the normal growth and morphogenic response of the tissues submitted to the viability detection test, nodal segments of tobacco were cultured for 15 days in basal propagation medium (MS medium) supplemented with different carbon sources. The culture media were prepared according to the protocol described in the preceding examples. Three different culture media were prepared, which were: without carbon source ( FIG. 6A ), culture medium supplemented with sucrose at 30 gL −1 as an energy source, and starch at 1.5 gL −1 ( FIG. 6B ) and culture medium supplemented only with starch at 1.5 gL −1 ( FIG. 6C ). [0059] FIG. 6 shows the effect of the different types of culture media on nodal segments of tobacco. In the photographs of FIGS. 6A and 6C , scarce growth of the plants is observed, showing that starch does not replace the carbon source for these cultures. On the other side, in FIG. 6B it can be appreciated that starch did not affect the growth of the cultured plant, and the growth and morphogenic response produced were normal for the plant.

1a

RELATED APPLICATIONS The present invention was first described in and claims the benefit of U.S. Provisional Application No. 62/032,868 filed Aug. 4, 2014, the entire disclosures of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates generally to a training device providing a method for assisting in training for a more effective breathing technique. BACKGROUND OF THE INVENTION The lack of proper breathing technique is often the initial cause of many physical illnesses. Without sufficient oxygen, one's organs—including the heart, lungs and brain will quickly weaken. Overtime, this oxygen deprivation ultimately affects the ability to perform daily activities including beneficial exercises which may then lead to other health problems. As such, it is well known that the ability to distribute oxygen to other organs within the body via the bloodstream is critical to not only increasing endurance, but maintaining and enhancing life as well. Without a proper breathing technique, users will always feel tired and unable to perform basic tasks. Furthermore, the ability to properly breathe aids in retarding the aging process, and revitalizes muscles for a long life. Accordingly, there exists a need for a means by which a user can be easily taught proper breathing techniques, and have such techniques reinforced so that such techniques become rote and easily reproduced in one's daily life. The use of the training device and method of use provides users the benefits of proper and healthy breathing, and helps teach them to breathe properly even when not using the invention. SUMMARY OF THE INVENTION The inventor has recognized the aforementioned inherent problems and lack in the art and observed that there is a need for a training device providing a method for assisting in training for a more effective breathing technique. It is therefore an object of the invention to provide a training device, comprising a support frame which comprises of a foot platform and a seat platform which are vertically upstanding and secured near an end of the foot platform. The device also comprises a training device assembly which has a rotating member, a transmission in mechanical communication with the rotating member via a pair of linkage members and secured within a housing attached to the rotating member, a pair of reciprocating handlebars each in mechanical communication with one (1) of the pair of linkage members, a device frame securing the rotating member and the housing to the foot platform, a processor configured to be in electrical communication with a power source, a display in electrical communication with the power source and located on the frame, a sensing means in mechanical communication with the rotation member and the transmission, and an abdominal pad adjustably attached to an upper end of a post, the post having a lower end attached to the housing. The device also comprises a resistance mechanism which is attached to each of the pair of handlebars. The foot platform also comprises a plurality of casters along the bottom surface. The support frame is secured to an upper surface of the foot platform using a plurality of fasteners which may be brackets. The seat platform may consist of a bench seat. The abdominal pad is designed with an outer curve which is adapted to align with the curves of a given user's abdomen. The abdominal pad comprises a plate affixed to a rear side of the pad and a fixture affixed to the plate opposite the pad. The fixture is capable of being secured at a given user's desired position along the post. The fixture consists of a hand knob, a threaded shaft mechanically secured to the hand knob and a support frame which has an aperture. The fixture is capable of traveling along the post and secured in place by the threaded shaft. The threaded shaft also has a captive feature which prevents the removal of the threaded shaft from the fixture. The method for using the device is as follows: step one (1), having a user obtain a device as described above; step two (2), having the user apply a force to the seat platform; step three (3), having the user adjust the abdominal pad to abut the user's abdomen; step four (4), having the user apply a force by pressing his or her abdomen against the abdominal pad; step five (5), having the user apply an alternating force by motioning the pair of reciprocating handlebars back and forth, resulting in the spinning of the rotating member; step six (6), having the user breath during steps one through five (1-5) through his or her nose and exhaling through his or her mouth; step seven (7), having the user continue the motioning, pressing, and breathing steps for a minimum of five minutes; step eight (8), having the user physically engage the display while performing the motioning, pressing, and breathing steps to regulate and monitor the user's performance; step nine (9), having the user adjust the resistance mechanism attached to each of the pair of handlebars to a desired greater or lesser force; step ten (10), having the user adjust the fixture along the length of the post; and lastly step eleven (11), having the user turn the hand knob which cause the threaded shaft to secure the fixture in place along the post. BRIEF DESCRIPTION OF THE DRAWINGS The advantages and features of the present invention will become better understood with reference to the following more detailed description and claims taken in conjunction with the accompanying drawings, in which like elements are identified with like symbols, and in which: FIG. 1 is a perspective view of a respiratory training device 10 , according to a preferred embodiment of the present invention; FIG. 2 is an environmental view of the respiratory training device 10 depicting an in-use state, according to a preferred embodiment of the present invention; FIG. 3 is a sectional view of the abdominal pad 75 along with its supporting structure as seen along a line I-I as shown in FIG. 1 , according to a preferred embodiment of the present invention; and, FIG. 4 is a mechanical force diagram depicting the actions and forces generated by the respiratory training device 10 , according to a preferred embodiment of the present invention. DESCRIPTIVE KEY 10 respiratory training device 20 user support frame 22 foot platform 25 seat platform 50 training device assembly 52 rotating member 54 training device frame 56 reciprocating handlebar 57 hand grip 58 display 60 resistance adjustment mechanism 62 linkage 64 transmission housing 66 caster 70 post 75 abdominal pad 78 plate 80 height adjustment fixture 100 user 105 abdomen 110 outer curved surface 115 hand knob 120 threaded shaft 122 captive feature 125 support frame 130 first applied force 135 second applied force 140 third applied force 145 fourth applied force DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The best mode for carrying out the invention is presented in terms of its preferred embodiment, herein depicted within FIGS. 1-4 . However, the invention is not limited to the described embodiment, and a person skilled in the art will appreciate that many other embodiments of the invention are possible without deviating from the basic concept of the invention and that any such work around will also fall under scope of this invention. It is envisioned that other styles and configurations of the present invention can be easily incorporated into the teachings of the present invention, and only one particular configuration shall be shown and described for purposes of clarity and disclosure and not by way of limitation of scope. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. The present invention describes a respiratory training device (herein described as the “apparatus”) 10 , which provides an exercise machine that provides an effective upper body workout while reinforcing a proper breathing technique. Referring now to FIG. 1 , a perspective view of the apparatus 10 , according to the preferred embodiment of the present invention, is disclosed. The apparatus 10 provides a user support frame 20 and a training device assembly 50 . The user support frame 20 includes a foot platform 22 and a seat 25 . The user support frame 20 provides an “L”-shaped structure onto which a user 100 occupies a rearwardly located seat 25 and places their feet upon a foot platform 22 during performance of an upper body and breathing training workout session. The user support frame 20 is envisioned being made of durable rigid materials such as, but not limited to: metal, wood, or plastic, and may be covered with carpeting, padding, or the like based upon a user's preference. It is envisioned that the foot platform 22 would provide a plurality of casters 66 along a bottom surface to provide convenient portability of the apparatus 10 . The foot platform 22 provides a means of attachment of a training device frame portion 54 of the training device assembly 50 using suitable brackets fastener portions. The seat 25 is stylized as a bench-type seating platform in a preferred embodiment. The training device assembly 50 is envisioned to provide a similar construction as a conventional stationary bicycle exercise machine including a rotating member 52 , a pair of reciprocating handlebars 56 with grip portions 57 , a resistance adjustment mechanism 60 , a processor; and, a digital display 58 in electrical communication with a sensing means in mechanical communication with the rotating member 52 . The sensing means communicates physical data gleaned from the rotating member 52 and coupled with the resistance settings of the adjustment mechanism 61 communicates performance parameters to the processor which is in electrical communication with the digital display 58 . The training device assembly 50 also includes a plurality of linkage members 62 and a transmission (not shown), housed in a housing 64 which mechanically couple the reciprocating handlebars 56 to the rotating member 52 , embodied as a front wheel of a stationary bicycle. The abdominal pad 75 includes an integral height adjustment fixture 80 along a rear surface which provides height adjustable attachment to a post 70 portion of the training device assembly 50 . The post 70 is envisioned to be made of rectangular tubing being insertable through the height adjustment fixture 80 , being integral to, and protruding upward from the training device assembly 50 to allow a user 100 to selectively position the abdominal pad 75 against their abdominal muscles 105 (see FIG. 2 ). The post 70 is supported by the transmission housing 64 , as it is located directly below and in front of the seat 25 . Referring now to FIG. 2 , an environmental view of the apparatus 10 depicting an in-use state, according to the preferred embodiment of the present invention, is disclosed. In use, a user 100 sits upon the seat 25 with their feet stationarily positioned upon the foot platform 22 , while grasping and motioning the reciprocating handlebars 56 . The user 100 may adjust a level of resistance to movement of the reciprocating handlebars 56 if desired using a knob portion of the resistance adjustment mechanism 60 . Additionally, the user 100 is encouraged to perform a particular breathing technique 100 during the workout to maximize an effectiveness of the workout routine (as described below). It is envisioned that the user 100 will experience a strengthening of heart and lungs, thereby obtaining a higher level of endurance. Referring next to FIG. 3 , a sectional view of the abdominal pad 75 along with its supporting structure as seen along a line I-I as shown in FIG. 1 , according to the preferred embodiment of the present invention is disclosed. The abdominal pad 75 is provided with an outer curved surface 110 that closely aligns with the abdomen 105 (as shown in FIG. 2 ) of the user 100 (as shown in FIG. 2 ). Said alignment is critical to the proper use of the respiratory training device 10 along with obtaining the maximum physical benefit. Alignment is obtained by use of the height adjustment fixture 80 which necessitates turning a hand knob 115 that is connected to a threaded shaft 120 . A feature 122 located on the distal end of the threaded shaft 120 enables the threaded shaft 120 to be held captive by a support frame 125 that slides along the post 70 . Simultaneously, the support frame 125 is mechanically connected to a plate 78 affixed to a rear of the abdominal pad 75 . When the proper position of the abdominal pad 75 is obtained by test fitting, trial and error process, the hand knob 115 is tightened down, forcing the threaded shaft 120 against the post 70 where it remains firmly in position until further adjustment, perhaps for a different user 100 , is necessary. The hand knob 115 is then loosened to enable further adjustment. Referring finally to FIG. 4 , a mechanical force diagram depicting the actions and forces generated by the respiratory training device 10 , according to a preferred embodiment of the present invention is disclosed. A first applied force 130 is generated when the user 100 (as shown in FIG. 2 ) sits upon the seat 25 . A second applied force 135 is generated by the abdominal pad 75 against the abdomen of the user 100 (as shown in FIG. 2 ). Said second applied force 135 is then magnified to improve the breathing process of the user 100 (as shown in FIG. 2 ) as the reciprocating handlebar 56 are driven back and forth in accordance with a third applied force 140 and a fourth applied force 145 as shown by the arms of the user 100 (as shown in FIG. 2 ). It is envisioned the tension and speed of the third applied force 140 and a fourth applied force 145 can be varied in an increasing manner as the user 100 (as shown in FIG. 2 ) improves with each cyclic use of the respiratory training device 10 . It is envisioned that other styles and configurations of the present invention can be easily incorporated into the teachings of the present invention, and only one particular configuration shall be shown and described for purposes of clarity and disclosure and not by way of limitation of scope. The preferred embodiment of the present invention can be utilized by the common user in a simple and effortless manner with little or no training. After initial purchase or acquisition of the apparatus 10 , it would be installed and utilized as indicated in FIGS. 1-4 . The method of configuring and utilizing the apparatus 10 may be achieved by performing the following steps: procuring the apparatus 10 ; sitting upon the seat 25 with feet flat on the foot platform 22 ; adjusting the height of the abdominal pad 75 against one's abdomen 105 using the height adjustment fixture 80 ; grasping grip portions 57 and motioning the reciprocating handlebars 56 forward and rearward in a reciprocating manner; pressing an abdominal area 105 against the abdominal pad 75 during the exercise; performing an enhanced breathing technique during the exercise by breathing in through the nose and exhaling through the mouth to increase oxygen intake into the body and muscles; continuing the exercise for approximately five minutes ( 5 mires) duration; utilizing the display 58 while exercising to regulate and monitor exercise parameters such as, but not limited to handlebar reciprocating frequency, heart rate, and duration; repeating the workout routine daily; strengthening heart and lung muscles by consistently performing the exercise over a period of time while practicing the breathing technique; and, benefiting from strengthened heart and lung muscles and a higher level of endurance, afforded a user 100 of the present invention 10 . It is envisioned that performing the exercise as described above in a consistent manner over a period of approximately thirty-five to forty-five days (35-45 d) will enable the user's body to experience a strengthening of heart and lung muscles, thereby obtaining a higher level of endurance. The present invention 10 improves the physical body condition of the user 100 and provides a lifelong benefit through continued reinforcing use. Said present invention 10 improves the blood oxygen level of the user 100 thus aiding in the retardation of the aging process, the rejuvenation of tissues and results in stronger lungs that will expel a higher percentage of carbon dioxide from the tissues. Usage per the described description will result in proper breathing and an improved quality of life. This is accomplished by “retraining” the lungs to a natural breathing process to obtain the maximum performance from the human body by burning food energy and not lactic acid. The actual retraining process is enhanced by pressure caused by the abdominal pad 75 pressing against the abdominal muscles thus forcing the proper breathing method by breathing in (inhaling) through the nose and breathing out (exhaling) through the mouth. The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated.

1a

BACKGROUND OF THE INVENTION This invention relates to poultry nest pads for use by poultry breeders and egg producers. More particularly, this invention relates to an improved poultry nest pad for egg laying hens. More particularly, this invention relates to an improved poultry nest pad that encourages an increased egg production from egg laying hens. DESCRIPTION OF THE PRIOR ART The individual farmer with a few chickens usually provided a house for the chickens with nests created from straw, or other available materials, to encourage egg laying at a location where the eggs could be easily gathered. As the poultry and egg industries grew, large houses became commonplace and new materials were desired for use as the nests to provide longer useful life for the nest and to provide a cleaner environment for the poultry and eggs. As a result rubber mats, mats made of non-woven materials and plastic nest pads such as, for example, the AstroTurf® poultry nest pad produced by Monsanto Company were developed. The AstroTurf poultry nest pad is produced as a thermoplastic, three-dimensional, molded grass-like product such as that shown in U.S. Pat. No. 3,507,010. These poultry nest pads were produced in the natural farm colors such as brown and green so that the pads would be accepted by the poultry. SUMMARY OF THE INVENTION This invention is directed to an improved poultry nest pad that encourages an increased egg production from egg laying hens. More specifically the invention is a gray poultry nest pad. The gray color utilized in this invention is specified as the color space defined by "The Munsell System" in terms of hue, value and chroma as set out in the Munsell® Book Of Color--Glossy Finish Collection, 1976 Edition by Macbeth® Division of Kollmorgen, in which: Hue is 2.5 R through 10 RP inclusive; Value is 3 through 9 inclusive; and Chroma is 0 through 2 inclusive. The gray color utilized in this invention is more preferably specified as the color space defined by "The Munsell System" in terms of hue, value and chroma as set out in the Munsell® Book Of Color--Glossy Finish Collection, 1976 Edition by Macbeth® Division of Kollmorgen, in which: Hue is 2.5 R through 10 RP inclusive; Value is 4 through 8.5 inclusive; and Chroma is 0 through 1 inclusive. An expanded view, or more detail, of a portion of the color space defined above is presented in the Munsell® Book Of Color--Nearly Neutrals™ Collection, 1991 Edition by Macbeth® Division of Kollmorgen. In addition to the definition above, the gray color may be specified as the color space defined as N3 through N9 inclusive, and preferably as N4 through N8.5 inclusive, as set out in The Munsell® Neutral Value Scale, 1971 Edition by Macbeth® Division of Kollmorgen. These and other features and advantages of the present invention will become apparent from the following detailed description, wherein reference is made to the figures in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a pictorial view of a portion of a poultry nest pad illustrating the projecting members and the perforations in the base of the liner. FIG. 2 is a pictorial view of the portion of a poultry nest pad of FIG. 1 after it has undergone a texturizing treatment to impart a grass-like resemblance to the liner. DESCRIPTION OF THE PREFERRED EMBODIMENTS This invention is directed to an improved poultry nest pad that encourages an increased egg production from egg laying hens. More specifically the invention is a gray poultry nest pad. The AstroTurf® poultry nest pad produced by Monsanto Company, shown in two embodiments in FIGS. 1 and 2, is the preferred shape for the poultry nest pad of this invention. This poultry nest pad is produced as a thermoplastic, three-dimensional, molded grass-like product such as that shown in U.S. Pat. No. 3,507,010, the specification of which is incorporated by reference. The poultry nest pad has a relatively flat matrix formed of parallel strips or ribs 21 separated by hollow, circular clusters or buds 22 from which projections 23 extend to simulate natural grass. The clusters 22 do not abut one another. They are separated from one another to provide openings or holes in the matrix between adjacent clusters 22 and through the center of the hollow clusters 22 to allow drainage through the poultry nest pad to enable easier cleaning of the nest pad and to enable waste or refuse from the hens to flow through the nest pad between cleanings. The projections 23 extending from the clusters 22 are essentially vertical after being molded, as shown in FIG. 1. To impart the appearance of natural grass it is necessary to texture the molded material to disperse the tips of the projections 23 randomly, much in the manner of natural grass. This may be conveniently done by applying a plate with pressure to the top of the molded material, that is, to the side from which the projections extend. This texturing imparts a permanent crimp in the projections 23 whereby they remain bent or flattened with the tips dispersed randomly over the surface, as shown in FIG. 2. While the poultry nest pad construction describe above is preferred, it is not the only construction that may be used. Rubber mats, mats made of non-woven materials and plastic materials having other configurations may also be used without detracting from this invention. The important feature of this invention is the provision that the poultry nest pads must be gray in color. Galvanized sheet metal color is the primary color seen by poults prior to their placement in the breeder house. Poultry research indicates that poults are imprinted by what they see at this young age. Thus, gray poultry nest pads resemble the galvanized sheet metal color and provide a more comfortable environment. The hens put on gray nesting appear to be more content than hens placed in houses with nest pads of other conventional colors and this encourages the hens to produce more eggs. Up to thirty-five percent more eggs were laid in the gray poultry nest pads than in nest pads of other colors. The gray color utilized in this invention is specified as the color space defined by "The Munsell System" in terms of hue, value and chroma as set out in the Munsell® Book Of Color--Glossy Finish Collection, 1976 Edition by Macbeth® Division of Kollmorgen, in which: Hue is 2.5 R through 10 RP inclusive; Value is 3 through 9 inclusive; and Chroma is 0 through 2 inclusive. The gray color utilized in this invention is more preferably specified as the color space defined by "The Munsell System" in terms of hue, value and chroma as set out in the Munsell® Book Of Color--Glossy Finish Collection, 1976 Edition by Macbeth® Division of Kollmorgen, in which: Hue is 2.5 R through 10 RP inclusive; Value is 4 through 8.5 inclusive; and Chroma is 0 through 1 inclusive. An expanded view, or more detail, of a portion of the color space defined above is presented in the Munsell® Book Of Color--Nearly Neutrals™ Collection, 1991 Edition by Macbeth® Division of Kollmorgen. In addition to the definition above, the gray color may be specified as the color space defined as N3 through N9 inclusive, and preferably as N4 through N8.5 inclusive, as set out in The Munsell® Neutral Value Scale, 1971 Edition by Macbeth® Division of Kollmorgen. The most common color currently used for nest pads is brown. A study was made to compare the results of using different colors for the poultry nest pads. In the study brown nest pads were compared in separate tests to red, green, black and gray nest pads. For the study, newly hatched chicks were raised and the nest pads were introduced during the chicks' twentieth week. Four groups of chicks were used in each test. In Test 1 brown and black nest pads were compared, in Test 2 brown and green nest pads were compared, in Test 3 brown and gray nest pads were compared, and in Test 4 brown and red nest pads were compared. In each test, an equal number of nest pads of each nest pad color were used. During the twenty-eighth and the thirty-second weeks, the number of eggs in each nest during a period of five days were counted. The number of eggs in the nests of each nest pad color were averaged to determine the number of eggs per nest per five day period (Eggs/Nest/5 Day Period) and the results are shown in Table 1. TABLE 1______________________________________Nest Color Eggs/Nest/5 Day Period______________________________________Brown 16.5Black 14.7Brown 17.5Green 16.1Brown 14.7Gray 19.9Brown 16.2Red 17.0______________________________________ In the tests comparing brown and black, brown and green, and brown and red nest pads, the hens did not exhibit any significant preference for one color of nest pad over the other color of nest pad. There was even a slight preference for the brown pad over the black and green pads. However, in the test comparing the brown nest pad to the gray nest pad, the difference in egg production was significant as there were more than thirty-five percent (35%) more eggs laid in the nests having the gray nest pad than in the nests having the brown nest pad. It will be apparent from the foregoing that many other variations and modifications may be made in the apparatus herein before described, by those having experience in this technology, without departing from the concept of the present invention. Accordingly, it should be clearly understood that the apparatus depicted in the accompanying drawings and referred to in the foregoing description are illustrative only and not intended to have limitations on the scope of the invention.

1a

[0001] This application is a divisional of U.S. patent application Ser. No. 13/880,928 filed Aug. 9, 2013, which entitled to the benefit of, and incorporates by reference essential subject matter disclosed in PCT Application No. PCT/GB2011/052033 filed on Oct. 20, 2011, which claims priority to Great Britain Application No. 1017711.1 filed Oct. 20, 2010, all of which are herein incorporated by reference. BACKGROUND OF THE INVENTION [0002] 1. Technical Field [0003] The invention relates to a position determination system for determining the position of one or more mobile units with respect to one or more fixed position base units. [0004] 2. Background Information [0005] Indoor real-time location systems (RTLS) can operate with different levels of accuracy depending on the system infrastructure. In general, a real time location system can provide a 3 dimensional position (e.g. x, y and z coordinates) using for example triangulation on ultrasound or radio frequency (RF) signal amplitudes (e.g. from a Wi-Fi infrastructure). However, when deployed in a single floor, it is not normally possible to determine an accurate vertical (z) coordinate. An accurate vertical coordinate can be obtained by installing significant additional infrastructure. For example, with additional infrastructure, three dimensional coordinates can be determined to centimeter accuracy. However this additional infrastructure can be very costly. [0006] In some scenarios there is high value in fixing the position along the vertical axis. For example in a home care or hospital setting it is essential to quickly establish if a patient has collapsed or fallen on the ground. It is sufficient to know which room the patient is in when lying on the floor, i.e. the horizontal (x, y) plane does not need to be determined to high accuracy, while the vertical (z) axis needs to differentiate between the patient lying on the floor and sitting in a chair. This is contrary to the accuracy of a normal indoor real time location system which provides high accuracy in the horizontal plane while providing low accuracy in the vertical axis. [0007] Accelerometers may appear appealing at first sight, but such an inertial system also requires attitude estimation (using gyros) and becomes rapidly complex. An inertial system would also need to be on all the time in order to integrate the acceleration to achieve velocity and position and would thus draw too much power for a battery powered tag. SUMMARY OF THE DISCLOSURE [0008] According to a first aspect, the invention provides a position determination system comprising one or more fixed base units and one or more mobile units, wherein the system is arranged to determine the horizontal position of a mobile unit based on the proximity of said mobile unit to at least one base unit and wherein the system is arranged to determine a vertical position of said mobile unit based on the air pressure sensed at the mobile unit and the air pressure sensed at one or more of the base units. [0009] Thus the base units and mobile units comprise means for determining air pressure e.g. air pressure sensors. By using air pressure sensors to determine the height (i.e. the vertical axis position or z-ordinate) of the mobile unit, the system can avoid the additional complexity and expense of the additional infrastructure described above. Although air pressure sensors need to be introduced into the system, these can be introduced into the existing units, i.e. the mobile units and base units. Installation of further base units is not required to increase the vertical accuracy of the system. [0010] In fact, although many systems may want to retain an accurate position determination in the horizontal (x, y) plane (e.g. to centimeter accuracy as described above), the system allows the system hardware to be reduced further where this is not required. For example, as mentioned above, in some circumstances room level accuracy is sufficient. This can be achieved with only a single base unit in each room. The base unit can simply determine the presence or absence of a mobile unit. Alternatively, even if more than one base unit can detect the mobile unit, the position can easily be determined to room level based on signal strength. In other arrangements it may be possible to use only one base unit per floor. [0011] By measuring the air pressure at the base unit which is in a fixed (static) position at a known height, and measuring the air pressure at the mobile unit which is mobile and at a variable height, the difference in pressure can be determined and thereby a difference in height can be calculated. Therefore the height of the mobile unit relative to the known height of the base unit can be determined. [0012] Recently, inexpensive low-power air pressure sensors have become available that can provide up to 10 cm height accuracy (i.e. they can detect the pressure change caused by 10 cms of vertical movement). In the case of a mobile tag worn on a patient's arm, this accuracy is sufficient to distinguish between the situations where the patient is sitting in a chair and lying on the floor. [0013] The air pressure sensor readings may inherently drift slowly over time. This can lead to inaccurate height determinations and consequently incorrect situation analysis (either false positives or false negatives). Sensor readings may drift due to changes in air pressure and also due to changes in temperature or mechanical stress within the sensor. For example pressure sensors are typically made using silicon microsystem technology and stresses can arise from differences in expansion coefficients between the materials that the pressure sensor is made of, e.g. between the packaging and the sensor itself. This drift is inherent to the sensor. Therefore preferably the position determination system comprises a plurality of base units and the system is arranged to determine a reference pressure based on an average of the pressures sensed at each of the plurality of base units. By combining the readings from multiple base units, the inherent sensor drift can be averaged out in order to provide the overall reference pressure. Depending on the infrastructure employed in the system, the readings from all base units may be combined or the base units may be formed into groups (for example one group per floor) and the readings of each group combined to provide a plurality of reference pressures. [0014] The air pressure sensor readings in the mobile units can also drift over time. It is not practical to provide multiple pressure sensors in each mobile unit, so the above averaging scheme cannot be employed. The mobile units could simply be calibrated manually at regular intervals to ensure readings are accurate. However, preferably the position determination system comprises at least one height reference base unit and the system is arranged such that when a mobile unit is determined to be within a certain proximity of said height reference base unit the system determines that the mobile unit is at a predetermined mobile unit reference height. In response to said proximity determination, the system may instruct the mobile unit to perform a calibration based on the mobile unit reference height. [0015] To explain further, in certain situations a mobile unit can be assumed to be within a certain narrow height band. For example, when a patient is passing through a door or along a corridor it can be assumed that the patient is walking Therefore a mobile unit worn on a person's arm is at a fairly consistent height above ground. At such times, the height of the mobile unit is known and the current air pressure at that height is known from the base units, so the pressure sensor in the mobile unit can be calibrated to be consistent with the base units. This may be done by sending correction information to the mobile unit or it may be done by storing correction information elsewhere within the system to be applied to all pressure data collected from that mobile unit. [0016] Preferably the mobile unit can be instructed to increase a communication rate when in close proximity to the height reference base unit. This allows the system to detect the point at which the mobile unit and the base unit are closest which will allow a more accurate calibration to be performed. When the units are closest together, the pressure-height relationships at the two locations will be most similar. [0017] The predetermined height may be different for each tag. For example, people can be different heights. Therefore mobile units (tags) worn by those people will be positioned at different heights above ground. Consequently, when those people pass through the calibration zone, the calibration will need to take into account those different heights. Preferably each mobile unit for use with the system has a unique identifier and the system can determine which mobile unit is passing the height reference base unit. The system can then look up the identifier in a database in order to find the expected height of that mobile unit in order to perform the calibration correctly. In alternative embodiments, the expected height of each mobile unit may be programmed into the respective mobile unit. Calibration can then be effected either by transmitting the expected height data from the mobile unit to the base unit or by transmitting pressure data from the base unit to the mobile unit. Processing for performing the calibration calculations can be carried out either on the mobile unit, on the base unit or on a separate processor connected to the system. [0018] In some arrangements the system may comprise a height calibration zone. Said height calibration zone could be any height determination system which can establish a height of the mobile unit. The height determination system may comprise a plurality of base units positionally arranged so as to be capable of determining the height of a mobile unit based on the proximity of said mobile unit to each of said plurality of base units. In this way an accurate vertical axis position can be obtained without use of the pressure sensors. In response to said height determination, the system may instruct the mobile unit to perform a calibration based on a determined height of the mobile unit and/or a reference pressure. The calibration may be performed on a server or within the mobile unit as discussed in more detail later. Although this arrangement requires the extra infrastructure for accurate vertical axis determination, that infrastructure is only required in the location of the calibration zone, not throughout the system. The additional cost is therefore minimized [0019] Preferably the system is arranged to raise an alarm based on one or more criteria being met by the system. More preferably, one of the criteria involves information taken from a mobile unit. The alarm could take the form of an audible alert (e.g. a siren), a visual alert (e.g. flashing light), or an alert on a computer system (which can notify one or more users of the system). The alarm could also take the form of paging one or more persons (e.g. medical staff) or telephoning one or more persons (e.g. relatives or friends) and playing a recorded message. Preferably the alarm is arranged to indicate an identification of the mobile unit and a current position of the mobile unit. This enables the alarm respondents to proceed to the location of the particular mobile unit quickly and efficiently. [0020] Preferably one alarm criterion is based on the current height of the mobile unit. As described above, in a medical or care environment this criterion can be used to detect a patient collapsing or falling to the floor. Another alarm criterion may be based on a threshold amount, a difference of height and/or rate of change of height of said mobile unit: e.g. a sudden change of height can be indicative of a patient collapsing. [0021] In preferred embodiments the criteria depend on the current position of said mobile unit. For example, if the system is being used to detect patient emergencies by detecting a patient collapsing, it is important to distinguish certain zones such as stairs where a patient (and corresponding mobile unit) should be allowed to descend to and below the floor level without raising an alarm. Similarly, a patient may sink rapidly into a chair or onto a bed when there is no emergency situation. [0022] In such situations, a number of different data can be combined to make a more accurate determination of an alarm situation. For example, the height data can be combined with the height change data to establish for example if a patient descended rapidly, but not to floor level, or if the patient descended to floor level slowly and deliberately (e.g. to pick something up or to look under a bed). In situations which are unclear, further data may be gathered as described in more detail below. [0023] The base unit and the mobile unit may be arranged to communicate via ultrasound—i.e. they are provided with respective ultrasound transmitters and/or receivers. Alternatively or additionally, the base unit and the mobile unit may be arranged to communicate via radio communication i.e. they are provided with respective radio transmitters and/or receivers. In either case communications may be one way or two way. Different communication set-ups may be preferred in different situations. For example, radio waves can pass through solid objects more readily than ultrasound waves. In situations where position determination is to be carried out on a room-level within a building, ultrasound may be preferred as sensors in neighboring rooms are less likely to detect a mobile unit. Electromagnetic radiation can also interfere with important equipment within a hospital or care environment, again favoring ultrasound. Alternatively, in irregularly-shaped rooms or where many obstructing objects may be located, electromagnetic radiation may be preferred. [0024] The height determination of the mobile unit may be based on pressure data combined with height determination based on proximity to the base units. For example, a crude estimation of height may be obtained based on location relative to the base units (e.g. by triangulation or trilateration) without using the pressure data. The pressure data (which is likely to be more accurate) can then be combined with this crude height estimate in order to provide a more precise height determination. The techniques of sensor fusion may be employed in combining the various data. [0025] In preferred embodiments, a stationary mobile unit may be arranged to act as an additional base unit. When the mobile unit is stationary (as determined by a motion sensor or by external position detectors for example), it can essentially provide the same function as a fixed base unit. With this arrangement all stationary mobile units can be used to improve the reference pressure estimation without the complexity and expense involved in adding extra base units to the system. [0026] Preferably, the mobile units and/or the base units comprise temperature sensors. Temperature sensors can be used in the calibration of the pressure sensors. [0027] According to another aspect, the invention provides a mobile unit for use in a position determination system, said mobile unit comprising an air pressure sensor and a transmitter arranged to transmit data from said air pressure sensor to said system. The transmitter may be an ultrasound transmitter. [0028] In some embodiments the mobile unit comprises a receiver and the unit is adapted to transmit position data including at least data from said pressure sensor in response to receipt of an instruction or request signal. [0029] Preferably the mobile unit is adapted to receive a calibration instruction and in response to said calibration instruction the mobile unit is adapted to calibrate the pressure sensor. The calibration instruction may include at least a reference pressure and/or a reference height. [0030] The pressure sensor is preferably capable of determining height (altitude) to the nearest 30 cm, more preferably to the nearest 20 cm, more preferably still to the nearest 10 cm. [0031] The mobile unit and the base units preferably sample the air pressure at regular intervals. The mobile unit may comprise a motion sensor and the mobile unit may be adapted to reduce the frequency of sampling of the air pressure when the motion sensor senses that the mobile unit has not moved for a predetermined time. The frequency may be reduced to zero, but preferably the air pressure is sampled regularly to compensate for drift. When the mobile unit is stationary, all changes in pressure can be assumed to derive from sensor drift or from atmospheric pressure changes. [0032] In preferred embodiments, the mobile unit described above is used as part of the position determination system described above. [0033] According to a further aspect, the invention provides a building comprising a position determination system as described above, the building comprising one or more monitoring zones for positioning mobile units, wherein each monitoring zone comprises at least one base unit. Preferably at least one monitoring zone comprises only one base unit. The one or more monitoring zones may each correspond to a room within the building. A building thus fitted with a position determination system can be used to locate monitoring units to within room accuracy. [0034] Intelligent buildings are becoming more commonplace, with sensors being fitted to more and more components of the building and capable of sending data to a central monitoring station. Such sensors can provide useful further indications of a particular situation and therefore incorporating these sensors into the system logic can provide more reliable situation analysis. This can result in fewer false positive and/or false negative determinations. As an example, a system which determines a patient emergency situation based on the sensed pressure data, can determine that the situation is most likely a false positive if immediately afterwards, the door of the detected room is shut and the light switched off Preferably therefore the position determination system is adapted to receive data from one or more sensors within the building, the sensors including at least one of: a light switch sensor, a motion sensor, a door sensor and a telephone activity sensor. Preferably the position determination system is adapted to raise an alarm based on one or more criteria being met by a mobile unit and based on the output of said building sensors. [0035] According to another aspect, the invention provides a method of determining the position of a mobile unit relative to one or more fixed base units, comprising: measuring the air pressure at the position of said mobile unit; measuring the air pressure at the position of said base units; measuring the proximity of the mobile unit to said base units; determining the horizontal position of said mobile unit based on said proximity measurements; and determining the height of said mobile unit based on said air pressure measurements. [0036] It is to be understood that, where preferred features have been described above in relation to one aspect (e.g. the system, mobile unit, building or method), they are equally applicable to all other aspects. The different aspects described above are all inter-related and form part of the same overall system. [0037] Although some of the features above have been described in relation to a hospital or other care environment for detecting patient emergencies, it will be understood that the system can also apply to a large number of other situations. [0038] In one example, the system could be used as part of an equipment or inventory monitoring system for locating specific pieces of equipment or items of stock, and for detecting misplacement of articles. For example, an alarm could be raised if fragile items are detected as moving above a certain height which is considered to be risky. [0039] In one set of embodiments the system is arranged to raise an alarm when a mobile unit is in a predetermined zone and its rate of change of a vertical coordinate is less than a threshold value. The zone may be a stairwell, a ramp or a lift shaft or some other such region of the system premises in which the height of a mobile unit may be expected to change (increase or decrease) at a certain rate. For example in a care environment as described elsewhere in this document, a patient in a stairwell is expected to be ascending or descending the stairs. If a mobile unit attached to the patient indicates that the patient is not changing their vertical coordinate, it may indicate that the patient is in difficulty and an alarm should be raised. As with the other systems described in this document, the horizontal position determination need not be particularly accurate—it could be accurate only to room level (e.g. sufficient to locate the stairwell in which the patient is located). [0040] Such an arrangement is novel and inventive in its own right and thus according to another aspect the invention provides a monitoring system comprising a three dimensional position determination system for determining the three dimensional coordinates of one or more mobile units, said system comprising at least one zone in which the system is arranged to raise an alarm when the rate of change of a vertical coordinate of a mobile unit is less than a predetermined value. [0041] In this system, the vertical coordinate could be determined by any means, e.g. by air pressure sensors as previously described or by means of ultrasound or RF signals. [0042] In a set of embodiments the system according to the aspect of the invention set out above further comprises at least one zone in which the system is arranged to raise an alarm when the rate of change of a vertical coordinate of a mobile unit is greater than a predetermined value. As described elsewhere, the system needs to distinguish between the two types of zone as the conditions for raising an alarm change when the patient moves from one type of zone to the other. In an ordinary room, the patient is expected to remain mostly at a constant height and an alarm should be raised if that height changes rapidly. BRIEF DESCRIPTION OF THE DRAWINGS [0043] Preferred embodiments of the invention will now be described, by way of example only, and with reference to the accompanying drawings in which: [0044] FIG. 1 shows a floor of a building with a location system according to the invention; and [0045] FIG. 2 schematically illustrates a mobile unit and a base unit. DETAILED DESCRIPTION OF THE INVENTION [0046] FIG. 1 illustrates a floor 100 of a building which has been fitted with a real time location system embodying the invention. The floor 100 is divided into a number of separate spaces 101 to 108 . 101 is a stairwell with stairs leading up and/or down to floors above and/or below. 102 to 107 are various rooms and 108 is a corridor. In particular, room 105 is a monitoring room containing a central computer 130 which may be monitored by an operator 134 . It should be appreciated however that the computer 130 may be located elsewhere within the building or completely off site, connected to the system through a direct connection, or over a network and/or the interne. [0047] FIG. 2 schematically illustrates a mobile tag 140 and a base station 110 in communication with each other. The base station 110 is fixed to a static structure of the building such as a wall, floor or ceiling. It has a receiver 220 and a transmitter 222 . These may be any kind of wireless transmitter and receiver, but most conveniently ultrasound or radio frequency (RF) electromagnetic communication are used. Ultrasound is advantageous in care environments as electromagnetic waves can interfere with other equipment in the building. Ultrasound also does not penetrate the walls and so interference between base stations or from background noise is reduced compared with electromagnetic transmissions. Combinations of ultrasound and electromagnetic communication may be used. [0048] The base unit 110 includes an air pressure sensor 224 and a temperature sensor 226 . These are illustrated separately, but in practice the two sensors could be combined on a single sensor circuit. The base unit 110 also includes a processor 228 and memory 230 . The processor 228 controls the transmitter 222 and receiver 220 for transmitting and receiving data and also reads data from the pressure and temperature sensors 224 , 226 . Memory 230 may be used during the processing procedure and may also store historical data and/or preloaded values such as predetermined values or thresholds for use in calculations and/or database structures (which may be populated or unpopulated with data). All of these data values may be updated during the course of operation. [0049] The mobile unit or tag 140 is mounted on a strap 202 which can be used to attach the tag 140 to a person or object. In some preferred embodiments, the strap 202 is an arm band. The tag 140 has a transmitter 204 and a receiver 206 . As with the base unit 110 , these may be ultrasound transducers or RF antennae or combinations of both. The tag 140 also has an air pressure sensor 208 and a temperature sensor 210 similar to the base station 110 . Again, the transmitter 204 , receiver 206 , pressure sensor 208 and temperature sensor 210 are all operated by a processor 214 which again has a memory 216 available for use. Additionally, a motion sensor 212 is provided (also connected to the processor 214 ) for use as described below. [0050] For the pressure sensors and temperature sensors 208 , 210 , 224 , 226 the units 110 , 140 may use the SCP1000 from VTI and/or the MS5607 from MEAS Switzerland. These devices are low power, relatively inexpensive and can provide a height measurement accurate to within 10 cm. Both units also incorporate a temperature sensor. [0051] First the overall infrastructure will be described with reference to FIG. 1 . The description below is given in relation to a care environment where the tags 140 are attached to patients and the system is arranged to detect emergency situations when a patient collapses. A number of tags 140 a - d are shown in different locations within the floor. [0052] One or more base stations (base units) 110 are provided per floor 100 of a building, each of which contains an air pressure sensor 224 (shown in FIG. 2 ). The base stations 110 are statically located, i.e. they are at known fixed positions. The height above the floor of each base station 110 is known. The base station 110 samples the air pressure at regular time intervals. The sampling interval may depend on whether the unit 110 is battery powered or externally powered. [0053] A tag (mobile unit) 140 is attached to a patient, e.g. via an arm band 202 . The tag 140 also contains a pressure sensor 208 (shown in FIG. 2 ). The air pressure at the tag 140 is transmitted, either via ultrasound (US) or via radio frequency electromagnetic radiation (RF), and the system calculates the difference in air pressure between the tag 140 and the base station 110 . [0054] The altitude H is given by [0000] H = T G [ 1 - ( P P 0 ) ( GR g ) ] ( 1 ) [0000] where: T is the temperature in Kelvin, P is the pressure, P 0 is a reference pressure at a fixed height, G=−dT/dH is the negative of the temperature gradient, R is the specific gas constant, and g is the acceleration of gravity. [0061] It can be assumed that the temperature within the vicinity of a pressure base unit is constant, or alternatively the system can compensate for it as a function of height based on the fact that hot air rises to the ceiling. [0062] If all pressure base units are at the same height, that height and the corresponding pressure may be used as the reference height and pressure. In general, if the base units are at different heights, each unit must convert its measured pressure to a reference pressure at a common reference height (e.g. at the floor). [0063] The temperature gradient may also be measured by using temperature sensors at different heights, e.g. at the floor and at the ceiling (or at the highest relevant height for the installation). [0064] For the calculation of height differences within rooms, the above formula can be approximated as: [0000] Δ   H = - ( R g ) · T · ( Δ   P P ) ( 2 ) [0000] where P is the reference pressure and AP is the pressure difference between the mobile unit and the base unit. [0065] Equation (2) is a low power variant of equation (1) which may be simpler to implement in mobile units. [0066] Hence, the air pressure measurements in the tag 140 and in the base station 110 provide a measure of the height difference between the two. Knowing the height of the base station 110 above the floor, the height of the tag 140 above the floor can be deduced. In particular, it can be determined whether the tag 140 (and the patient) is possibly lying on the floor or not. [0067] The air pressure measurements are associated with considerable noise. For example, the pressure in the region of the sensor will be continually varying due to the constant movement of air due to movement of people, opening of doors, circulation of air caused by fans, etc. Signal conditioning such as averaging over multiple samples, low-pass filtering, or Kalman filtering may be applied in order to get a robust measure of the height above the floor. [0068] The air pressure sensor readings may inherently drift slowly over time. Using multiple base stations 110 with air pressure sensors 224 on the same floor 100 , this drift can be averaged out to provide a reference air pressure for the floor (assuming the drift is of a random nature, the drifts from each base station will cancel out when averaging over several base stations). [0069] Drift in the air pressure sensors 208 in the tags 140 can be compensated in a number of ways. Some tags 140 include a motion sensor 212 that can be used to make the tag 140 enter a sleep mode when the tag 140 is stationary. In this mode, the air pressure can be sampled occasionally to compensate for drift. The process of air pressure calibration and drift compensation can be preformed in the background even though the mobile unit is stationary (in the case where it has a motion sensor and would otherwise be asleep to save power). [0070] In some embodiments, when the tag is stationary (as indicated for example by the motion sensor), the tag can perform the role of a base station, communicating with the other base stations and improving the reference pressure estimation and saving cost in the infrastructure. [0071] Another way to compensate for drift in the sensors of the mobile tags 140 is to assume a height band when the system detects motion from room to room. For example, a tag 140 attached to a patient's arm can be assumed to be in a rather narrow height band if one can determine that the patient is walking Such an arrangement is illustrated in the corridor 108 of FIG. 1 where mobile unit 140 d is passing along the corridor. It should be noted that although two base units 110 are shown in the corridor 108 , only one base unit 110 is required for this method of calibration. When the unit 110 detects that the tag 140 d is in close proximity (e.g. within a threshold distance), it determines that the patient wearing tag 140 d is in the corridor in the vicinity of the base unit 110 and is therefore almost certainly walking. It can therefore assume that the tag 140 d is at some predetermined height. The predetermined height will vary from patient to patient (according to the patient's height) and is preferably stored in a database on the central computer 130 . The unit 110 can contact the central computer 130 (either through a direct connection or over a network and either wired or wirelessly) to request the predetermined height for that tag 140 d . Each tag has a unique identifier which can be read by base unit 110 and sent to the central computer 130 . The central computer looks up the identifier in its database and returns the appropriate predetermined height to base unit 110 . Alternatively all calibration calculations can be performed on the central computer 130 which can then return calibration values (pressure and/or height) to the base station 110 . [0072] If the tag is capable of receiving data, base unit 110 can send calibration data (e.g. a current height and/or a corrected pressure reading) to the tag 140 so that the tag 140 can recalibrate itself. In an alternative arrangement, the tag 140 could have the predetermined height programmed into it, e.g. stored in memory 216 (which could be random access memory, flash memory or similar). An on board processor unit 214 can perform the recalibration calculations. If the tag 140 is not set up to receive incoming data or instructions then the unit cannot be instructed to recalibrate. Instead, the tag 140 d sends its pressure data as normal to the base unit 110 and the base unit 110 (or the central computer 130 ) determines an error between this reading and the reading that would be expected for the predetermined height. This determined error can be stored (e.g. in a database on central computer 130 ) alongside the unique identifier for tag 140 d and used to apply a correction to all data received from tag 140 d . Every time the tag 140 d passes through a recalibration zone, the calculation can be performed again and the database can be updated with corrected data. [0073] Another way to compensate for drift is to take advantage of zones instrumented for full 3D positioning to calibrate the air pressure reading from the tag 140 . Such zones do not rely on any pressure data in order to determine an accurate height for the tag 140 . These zones can be deployed for the purpose of general 3D positioning as illustrated in room 104 of FIG. 1 which has three base units 110 attached to the walls and preferably has a further base unit 110 mounted in the ceiling or floor to provide an accurate z-coordinate (i.e. height above the floor). Calibration can be performed in a manner similar to that described previously. [0074] Where the tag 140 is constrained to move through portals, e.g. doors, narrow corridors, etc, height estimation infrastructure may be deployed specifically to provide an accurate height measure. For example a series of receivers (which could be a base unit 110 ) arranged in a vertical array could simultaneously detect the proximity of a tag 140 as it passes by. The receiver which receives the strongest signal is determined to be the receiver at the closest height to that of the tag 140 thereby providing a simple yet accurate height detection method. If the tag is fitted with two-way communication, the tag can be instructed to enter a frequent update mode to provide accurate position estimation, for example to catch the exact moment when the tag 140 moves through a door. [0075] Fall detection (e.g. the collapse of a patient) can, in the simplest embodiment, be detected simply on the basis of the height of a tag 140 being detected at or near the floor. However, there may be other reasons for a tag being at or near the floor, such as a patient bending down to pick something up or to access a low drawer or cupboard. Therefore a system relying solely on the current height of a tag is liable to trigger false positive alarms, i.e. the system could raise an alarm when the situation does not require it. Such a system is however reasonably robust to false negatives, i.e. it should reliably detect most situations where a patient has collapsed to the floor and correctly raise an alarm. [0076] In a slightly more advanced system, fall detection can also be triggered by a sudden drop in height, independent of the reference pressure in the base station 110 . The mobile unit 140 can raise the alarm itself based solely on its own data. However, the base station 110 can provide extra information about the starting height and finishing height of the tag. For example, the base station 110 can confirm that the tag actually ended up on the floor. An intelligent system can combine these pieces of information and raise an alarm based on the sudden drop in height together with the information that the finishing height is at or near floor level. [0077] In yet more advanced systems, the indoor real time location system may additionally have zoning within rooms. For example, as shown in room 104 of FIG. 1 , the system can identify different areas within the room. Such areas may include areas containing beds, sofas, chairs, stairs, etc that can be associated with typical patient/tag heights, and can provide additional filtering information for providing reliable alarms. As shown in FIG. 1 , two special zones have been identified (and programmed into the system) in room 104 . The first zone 120 is a zone containing a bed 122 . When a patient is lying on the bed 122 , a tag 140 can be expected to be within a predictable height band and can be expected to remain at that height for some time. A second zone 124 contains a table 126 and four chairs 128 . Again, tags 140 within this zone 124 can be expected to remain mostly within a certain predictable height band, but will be prone to sudden rises and falls as people sit down or get up. The heights of the tags 140 should not however end up at floor level. The system may also combine time information with the spatial zones, for example time periods may be identified when a person is expected to be in bed 122 or dining at table 126 . [0078] As shown in room 107 of FIG. 1 , an intelligent building may be equipped with a number of other sensors which can feed data into the position detection system and can be used in determining alert situations. Room 107 contains a motion sensor 150 (e.g. an infrared, ultrasound or radar motion detector such as may be used in a burglar alarm system), a light switch sensor 152 which indicates the current state (on/off) of the light, and a door sensor 154 which indicates whether the door is open or closed. It will be appreciated that these are just examples of sensors which could be used and many others could just as easily be incorporated into the system. [0079] With all of this sensor data available to the system, substantial logic can be built involving all available sensor readings, e.g. air pressure (at the tag 140 and base units 110 ), ultrasound and/or RF signals from the tags 140 and other indicators such as telephone activity, motion evidence from a burglar alarm, operation of light switches, opening of doors, and other sensors in the intelligent building. It will be appreciated that the fall detection alarm needs to be reliable. In a home care setting, there is a high cost of false positives as emergency procedures will be initiated when the alarm is set off. Likewise, false negatives may be disastrous for the persons not getting the proper attention. In general, the more information that is available, the more reliably the situation can be determined. [0080] It will be appreciated that indoor real time location systems can provide additional information like motion detection via Doppler shift that can also be used to verify the fall detection alarm. [0081] In some situations, the logic for determining an alert situation can be significantly different, depending on the location. In particular, there could be zones for stairs with dedicated logic such that there will be no alarm when the tag descends towards (and through) the floor level. At the same time, within a stair zone, an alarm should be issued if the height remains constant, regardless of the height; or if it reduces too quickly. [0082] In general, the air pressure sensors can be used to allow three dimensional positioning in an infrastructure deployed for two dimensional positioning. This set up is not only useful for the fall detection case outlined above, but can be used in all situations where three dimensional positioning is useful. The cost benefits of using the pressure sensors in place of additional ultrasound or RF base units still apply in such situations. [0083] It will also be appreciated that the above principle of using an air pressure sensor to detect the height of a mobile unit 140 can be combined advantageously with any RTLS independent of the type of positioning principle deployed. Further, the tags 140 and base stations 110 described above can interact easily with existing tags (without pressure sensors) or with two dimensional infrastructure, simply without using the pressure information. Similarly, existing two dimensional infrastructure can be upgraded easily and conveniently simply by adding pressure sensors to existing base units or by replacing old base units with new ones. Such upgrades need not involve installation of additional units to provide full three dimensional positioning. [0084] Although this invention has been shown and described with respect to the detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail thereof may be made without departing from the spirit and the scope of the invention.

1a

BACKGROUND OF THE INVENTION A. Field of the Invention The present invention relates to mirrors of the type used by people to facilitate performance of personal care functions such as shaving, applying cosmetics, and the like. More particularly, the invention relates to a novel travel mirror device which is collapsible into a compact, lightweight, readily transportable assembly, and which includes a pair of mirrors of different relative magnification and an integral annular illuminator which is effective in illuminating objects in front of both mirrors. B. Description of Background Art People who travel frequently to distant locations often must deal with the absence of conveniences which are taken for granted in their home environments. For example, women who perform grooming tasks such as applying cosmetics and the like typically perform such tasks at a customary location which is adequately lighted and which is provided with a fixed wall-mounted mirror, or a mirror which rests on a table, vanity or the like. However, lodgings at travel destinations usually do not have the optimal arrangements of lighting and seating located near a suitable mirror, such as one has available at his or her personal residence. Also, many people find it useful to have available mirrors with different magnification factors greater than the unitary or 1× imaging factor of conventional flat mirrors. For example, mirrors having 5× or 9× magnification factors are useful in facilitating the performance of detailed grooming procedures. But most travel lodgings have at best 1× flat mirrors which do not provide magnified images. In view of the foregoing considerations, it would be desirable to have a mirror device which has multiple magnification factors, and an integral light source for illuminating an object such as a person's face within the object field of the mirror. Moreover, it would be desirable to have a dual magnification mirror with an integral illumination source, which could be folded into a lightweight, compact configuration in which reflecting surfaces of two mirrors were protectively enclosed for transport in a purse, briefcase or the like, yet be readily unfoldable at a use site such as a hotel room to deploy for use a mirror of selected magnification, adequate size, and adjustable orientation. The present inventor is unaware of any existing mirror device which possesses the foregoing characteristics and the unavailability of the desired combination of features was a factor motivating the present invention. OBJECTS OF THE INVENTION An object of the present invention is to provide a portable illuminated, dual magnification mirror device which is sufficiently small and light in weight to be conveniently and safely transportable in a traveler's luggage, carry-on bag, purse or briefcase. Another object of the invention is to provide an illuminated travel mirror which includes a mirror assembly that includes a first or primary mirror having a first magnification and a peripheral annular illumination source which is effective in illuminating an object field in front of the primary mirror. Another object of the invention is to provide an illuminated travel mirror which includes a peripherally illuminated primary mirror having a first image magnification factor, and a secondary mirror having a second image magnification factor which is mounted to an edge of a frame holding the primary mirror by a hinge coupler that enables the secondary mirror to be pivoted from a compact transit and storage configuration overlying and covering the primary mirror to a use configuration deployed radially outwardly from the primary mirror. Another object of the invention is to provide an illuminated travel mirror which includes a primary mirror mounted in a primary frame provided with a peripheral annular illuminator, a secondary mirror mounted in a secondary frame which has a peripheral light-transmissive annular ring-shaped bezel, and a hinge coupler provided with a pivotable joint which connects peripheral edges of the primary and secondary frames and which enables the secondary mirror to be pivoted to a position overlying the main mirror frame, enabling light from the illuminator of the primary mirror frame to be transmitted through the light transmissive bezel of the secondary mirror and thereby illuminate an object field in front of the secondary mirror. Another object of the invention is to provide an illuminated travel mirror which includes a base, an elongated handle which has a lower end pivotably mounted to the base by a handle joint, a dual mirror assembly telescopically mounted to an upper end of the handle assembly and which includes a first, primary mirror frame which holds a circular primary mirror that is effective in producing reflected images having a first magnification factor and an annular ring-shaped peripheral illumination source that at least partially circumscribes the primary mirror, a secondary, upper mirror frame which is pivotably connected by a hinge coupler to an upper part of the primary mirror frame at a location opposite to the end joined to the handle and which includes a second, secondary mirror having a different magnification factor than that of the primary mirror and which is circumscribed by a light transmissive peripheral frame portion or bezel, the hinge coupler connecting the secondary frame to the primary frame being so constructed as to enable the secondary mirror frame to be pivoted about a transverse axle of the hinge coupler away from a compact storage and transit configuration overlying the primary mirror frame to a use configuration disposed radially outwardly from the primary mirror frame, whereby the annular illumination source is enabled to illuminate an object field in front of the primary mirror, and whereby the secondary mirror frame is rotatable about a radially disposed swivel axis of the hinge coupler to position the reflective surface of the secondary mirror facing away from the primary mirror, and the secondary mirror frame pivoted towards an orientation overlying the primary mirror and illumination source, whereby light from the illumination source is enabled to be transmitted through the annular light-transmissive bezel ring of the secondary mirror, and thereby illuminate an object field in front of the reflective surface of the secondary mirror. Various other objects and advantages of the present invention, and its most novel features, will become apparent to those skilled in the art by perusing the accompanying specification, drawings and claims. It is to be understood that although the invention disclosed herein is fully capable of achieving the objects and providing the advantages described, the characteristics of the invention described herein are merely illustrative of the preferred embodiments. Accordingly, I do not intend that the scope of my exclusive rights and privileges in the invention be limited to details of the embodiments described. I do intend that equivalents, adaptations and modifications of the invention reasonably inferable from the description contained herein be included within the scope of the invention as defined by the appended claims. SUMMARY OF THE INVENTION Briefly stated, the present invention comprehends a portable travel mirror device which includes a pair of mirrors having different magnification factors, e.g., 1× and 5×, and an annular illumination source which is effective in selectably illuminating object fields of both mirrors. A dual magnification portable travel mirror with annular illuminator according to the present invention includes a base that has a generally flat lower surface for resting on a horizontal support surface, or optionally hanging on a wall. The travel mirror includes a mirror assembly support handle which is mounted to the base by a handle pivot joint that has a horizontally disposed pivot axis which enables the handle to be pivoted upwardly, from a compact storage/travel position in which the handle lies in a longitudinally fore and aft disposed groove in the upper surface of the base, parallel to the lower surface of the base, to an upstanding use position. The handle pivot joint includes a laterally disposed friction pad between the outer surface of a laterally disposed cylindrical axle located at a lower end of the handle, and the inner surface of a laterally disposed cylindrical cavity located within a front portion of the base. The handle pivot joint also includes a friction control thumb screw which exerts an adjustable axially directed compressive force on one or more cylindrical friction disk that bears against an end face of the handle axle. Combined radial and axial frictional forces exerted by the friction pad and disks, respectively, maintain the handle fixed at an adjustable elevation angle above the base. The travel mirror according to the present invention includes a dual mirror assembly which is telescopically mounted to an upper part of the mirror assembly support handle. The dual mirror assembly includes a circular dish-shaped primary mirror frame which has a generally flat front surface and a convex rear surface that has a circular perimeter and which is joined to the front surface of the frame by a convex, arcuately radiused annular edge wall. An elongated hollow rectangular handle boss tube protrudes outwardly from the rear surface of the primary frame, the boss being disposed symmetrically along a diameter of the rear frame surface between the flat circular portion of the rear frame surface, and the radiused edge wall. and extending nearly the full diameter of the mirror. The handle boss has a closed, rearwardly angled upper transverse end wall and a lower transverse end wall penetrated by a rectangular cross section channel which extends internally within the boss to the upper transverse end wall. The handle boss channel telescopically receives the upper end of the rectangular cross-section handle. Inside the channel is located a longitudinally elongated detent plate provided with a series of longitudinally spaced apart, laterally disposed detent grooves in a rear surface of the plate, which is located at the front or inner wall of the channel. Also, the front or upper longitudinally elongated rectangular wall of the handle has at upper end thereof a laterally disposed detent rib which is urged resiliently forward towards the grooved surface of the detent plate. The detent rib has an arcuately curved, generally semi-cylindrically shaped transverse cross section, i.e., is radiused, and is of the proper size and shape to snap resiliently into an adjacent detent groove when aligned therewith, and require a relatively large longitudinal force to be exerted on the handle to disengage the rib from the groove. Thus constructed, the primary mirror assembly is telescopically extendable and retractable with respect to the handle, to an adjustable position which is maintained by cooperative action of the detent rib and a detent groove. The primary mirror frame has in a front part thereof a shallow circular dish-shaped cavity in which is mounted a circular mirror of smaller diameter than the outer diameter of the frame. An annular ring-shaped peripheral channel around the mirror cavity holds a ring-shaped illumination source, preferably a thin, tubular cold-cathode fluorescent lamp. The lamp is energized by a high-voltage electrical current generated by a dc-to-ac inverter located in a hollow interior space within the base of the travel mirror and powered by batteries also located in the base. The front surface of the annular lamp channel is covered by an annular ring-shaped window which preferably has a diffusive light transmission. When the lamp is energized, a circular ring-shaped pattern of light emitted from the lamp and which is transmitted through the window is effective in illuminating an object field in front of the primary mirror. In a preferred embodiment, the primary mirror has a concave spherical shape which provides a magnified image of objects in front of the mirror, such as a person's face. The magnification factor of the primary mirror, which is inversely related to its radius of curvature, may be any desired value, but typically is in the range of 5× to 9×. According to the present invention, the mirror assembly includes a circular secondary mirror which has a different magnification factor than that of the primary mirror, e.g., 1× vs. 5×–9×. The secondary mirror is mounted in a circular frame which is pivotably mounted by a dual-joint hinge coupler at an outer, lower peripheral edge thereof to an outer, upper peripheral edge of the primary mirror frame. Preferably, the secondary mirror frame has an outer diameter approximating that of the primary mirror frame, and is pivotable downwardly to overlie the primary mirror, with the reflective side of the secondary mirror facing that of the primary mirror thereby protecting both primary and secondary mirrors when the travel mirror is telescopically and pivotably configured to a compact configuration for storage or travel. The secondary mirror frame has a circular plate-like shape which includes a generally flat, annular ring-shaped outer peripheral or bezel portion made of a light transmissive material. Also, the secondary mirror preferably has a diameter approximately equal to, or less than, that of the primary mirror. The hinge coupler which joins the secondary mirror to the primary mirror has two bearing axes, including a first, transverse pivot axis disposed along the center line of a transversely disposed axle which is parallel to a tangent to an upper peripheral edge of the primary mirror frame, and which pivotably supports the bushing of a hinge member fastened to a lower peripheral edge of the secondary mirror frame. The hinge coupler includes a second, swivel axis which lies along a center line of a swivel pin that protrudes radially outwardly from the lower edge of the secondary mirror frame and which is rotatable in a radially disposed journal bore centered between opposite sides of the pivot bushing. Thus constructed, the hinge coupler enables the secondary mirror frame to be pivoted away from a protective orientation overlying the primary mirror, to an upwardly angled orientation in which the surface of the secondary mirror faces generally forward, so that a person may view his or her face in either the primary mirror or the secondary mirror. Moreover, the primary mirror frame can be swiveled 180 degrees about the radially disposed swivel pin to thus position the reflecting surface of the s tation overlying the primary mirror, to an upwardly angled orientation in which the surface of the secondary econdary mirror in a rearward direction, away from that of the primary mirror. With the secondary mirror thus swiveled, the secondary mirror frame is pivotable downwardly to a position overlying and generally parallel to the upper surface of the secondary mirror, thus positioning the reflecting surface of the secondary mirror in the same forward-facing direction as that of the primary mirror. In this disposition, light emitted by the annular illumination source and transmitted through the annular ring-shaped window of the primary mirror frame is transmitted through the annular light transmissive bezel ring of the secondary mirror frame, thus illuminating an object field located in front of the secondary mirror. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A is a left side perspective view of a dual magnification travel mirror device with annular illuminator according to the present invention, showing the device in a fully telescopically and pivotably collapsed configuration suitable for travel. FIG. 1B is a left perspective view of the travel mirror device of FIG. 1A , showing a secondary mirror frame thereof pivoted upwardly from a dual mirror assembly of the device. FIG. 1C is a front perspective view of the device of FIG. 1B . FIG. 1D is a left perspective view of the travel mirror device of FIG. 1B , showing a secondary mirror frame thereof swiveled partially rearwardly. FIG. 1E is a front perspective view showing the secondary mirror frame swiveled 180 degrees from its disposition in FIG. 1A , and pivoted downwardly into a partial overlying use position relative to a primary mirror and base part of the device. FIG. 2 is a lower plan view of the travel mirror of FIG. 1 . FIG. 3A is a perspective view of a left-handed modification of the travel mirror of FIG. 1 . FIG. 3B is a perspective view of the travel mirror of FIG. 3A , showing a dual mirror assembly and handle portion of the device pivoted upwardly from a base part of the device. FIG. 4 is a front perspective view similar to that of FIG. 1E , but showing the handle of the device pivoted fully upwards from the base, and the dual mirror assembly telescopically extended to its maximum height. FIG. 5 is a rear perspective view of the arrangement of FIG. 4 . FIG. 6A is an exploded longitudinal sectional view of dual mirror assembly of the device of FIG. 1 . FIG. 6B is an upper plan view of a hinge coupler for the dual mirror assembly of FIG. 6A . FIG. 6C is a side elevation view of the hinge coupler of FIG. 6A . FIG. 6D is an upper plan view of the hinge coupler of FIG. 6A . FIG. 6E is an exploded sectional view of a base component of the mirror device of FIG. 1 . FIG. 6F is an exploded sectional view of a handle component of the mirror device of FIG. 1 . FIG. 7A is a fragmentary upper plan view of a primary mirror frame of the dual mirror assembly of FIG. 6A . FIG. 7B is a longitudinal sectional view of the primary mirror frame of FIG. 7A . FIG. 7C is a fragmentary lower plan view of the primary mirror frame of FIG. 7A . FIG. 7D is a sectional view of the frame of FIG. 7C , taken in the direction of line 7 D— 7 D. FIG. 7E is a fragmentary upper plan view of a secondary mirror frame of the dual mirror assembly of FIG. 6A . FIG. 7F is a longitudinal sectional view of the secondary mirror frame of FIG. 7E . FIG. 8A is a front perspective view of the left-hand mirror device of FIG. 3A , showing the handle pivoted rearwardly to an oblique angle, and showing an upper, secondary mirror of the dual mirror assembly pivoted upwardly away from a lower, primary mirror thereof. FIG. 8B is a fragmentary front elevation view of an annular diffuser plate for the primary mirror frame of FIG. 1 . FIG. 8C is a longitudinal sectional view of the diffuser plate of FIG. 8B . FIG. 9 is a side elevation view of the device arrangement of FIG. 8A . FIG. 10A is a perspective view similar to that of FIG. 8A , but showing the right-hand mirror device of FIG. 1 , with the upper, secondary mirror rotated 180 degrees about a longitudinal, radially disposed swivel axis lying in a vertical medial plane of the handle. FIG. 10B is a view similar to that of FIG. 10A , but showing the secondary mirror being pivoted downwardly about a transverse pivot axis perpendicular to the rotation axis, to thereby orient the frame side of the upper mirror next to the front surface of the lower mirror, thereby orienting the front, reflective surface of the upper mirror to a forward-facing use position. FIG. 10C is a view similar to that of FIG. 10B but showing the secondary mirror nearly parallel to the primary mirror, and showing light emitted by an annular illuminator of the primary mirror transmitted through a light transmissive bezel ring of the secondary mirror frame to thereby illuminate an object field in front of the secondary mirror. FIG. 11 is a left side perspective view of the left-hand mirror device of FIG. 3 , showing the dual mirror assembly thereof telescopically retracted on the handle towards the base of the device, and showing the upper mirror of the dual mirror assembly pivoted upwardly and rotated to orient the reflective surface of the upper mirror to a forward use position. FIG. 12A is an exploded lower perspective view of the mirror device of FIGS. 1A and 2 , showing an upper half shell portion of the base removed from a lower half shell portion and inverted. FIG. 12B is an enlarged lower view of the upper half shell portion of the base shown in FIG. 12A . FIG. 12C is a fragmentary lower plan view of the upper half-shell portion of the base of FIG. 12B , showing circuitry thereof removed. FIG. 12D is a transverse sectional view of the upper base half-shell of FIG. 12C . FIG. 12E is a longitudinal sectional view of the upper base half-shell of FIG. 12C . FIG. 12F is an upper plan view of the upper base half-shell of FIG. 12C . FIG. 12G is a transverse sectional view of the upper base half-shell of FIG. 12F . FIG. 12H is an upper plan view of the lower base half-shell of FIG. 12A , on a somewhat larger scale. FIG. 12J is a side elevation viewe of the lower base half-shell of FIG. 12H . FIG. 13 is an enlarged view of the mirror frame and handle assembly and the lower shell portion of the base shown in FIG. 12A , and showing handle-pivot friction control elements transferred from upper half shell grooves to lower half shell grooves, the mirror frame fully extended, and the secondary mirror swiveled into a use position overlying the primary mirror. FIG. 14 is a view similar to that of FIG. 13 , showing the handle portion of the device pivoted away from the base. FIG. 15A is a front elevation view of a front body shell portion of the handle of the mirror of FIG. 1 . FIG. 15B is a transverse vertical sectional view of the handle shell of FIG. 15A , taken in the direction of line 15 B— 15 B. FIG. 15C is a transverse vertical sectional view of the handle shell of FIG. 15A , taken in the direction of line 15 C— 15 C. FIG. 15D is a transverse vertical sectional view of the handle shell of FIG. 15A , taken in the direction of line 15 D— 15 D. FIG. 16 is a longitudinal sectional view of the handle shell of FIG. 15A . FIG. 17 is a rear elevation view of a rear cover portion of the handle of the mirror of FIG. 1 . FIG. 17A is a transverse vertical sectional view of the rear handle cover of FIG. 17 , taken in the direction of line 17 A— 17 A. FIG. 17B is a transverse vertical sectional view of the rear handle cover of FIG. 17 , taken in the direction of line 17 B— 17 B. FIG. 17C is a side elevation view of the rear handle cover of FIG. 17 . FIG. 17D is a longitudinal sectional view of the rear handle cover of FIG. 17 , taken in the direction of line 17 D— 17 D. FIG. 18 is a rear elevation view of a handle retainer detent plate which mounts in the primary mirror frame of FIG. 7 . FIG. 19 is a transverse sectional view of the detent plate of FIG. 17 . FIG. 20 is a longitudinal sectional view of the retainer detent plate of FIG. 18 . FIG. 21 is an enlarged fragmentary view of the detent plate of FIG. 20 . DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1A–21 illustrate various aspects of a dual magnification folding travel mirror with annular illuminator according to the present invention. Referring first to FIGS. 1A–8A , it may be seen that a dual magnification travel mirror with annular illuminator 20 according to the present invention includes a base 21 , an elongated, generally rectangularly-shaped handle 22 pivotably mounted at a lower end thereof to a front edge of the base by a handle pivot joint 23 , and a dual mirror assembly 24 telescopically mounted to an upper end of the handle. As shown in FIGS. 6A–9 , dual mirror assembly 24 includes a first, lower, or primary circular dish-shaped mirror frame 25 in which is mounted a first, lower or primary circular disk-shaped mirror 26 . As is also shown in those figures, dual mirror assembly 24 includes a second, upper or secondary circular plate-shaped mirror frame 27 in which is mounted a second, upper or secondary circular disk-shaped secondary mirror 28 . As shown in FIGS. 8A and 9 , secondary mirror frame 27 is pivotably and swivelably coupled to primary mirror frame 25 by a dual joint hinge coupler 29 . As shown in FIGS. 7A–9 , hinge coupler 29 is joined to primary mirror frame 25 by a pair of circumferentially spaced apart, parallel lugs 30 L, 30 R which protrude chordally outwards from an upper peripheral portion 31 of primary mirror frame 25 . As shown in FIGS. 6B–6D , hinge coupler 29 includes a laterally symmetrically shaped body 32 which has a generally cylindrically-shaped lower bushing member 33 that fits between inner facing surfaces 34 L, 34 R of lugs 30 L, 30 R. Bushing 33 has disposed laterally through its length a bore 35 which is coaxially aligned with and rotatable with respect to a transversely disposed pivot axle 36 which is disposed through the bore and which is fixed at opposite longitudinal ends thereof in bores 37 L, 37 R through lugs 30 L, 30 R. Body member 32 of hinge coupler 32 includes a generally rectangularly-shaped, laterally elongated boss 38 which protrudes radially outwardly from lower bushing portion 33 . Boss 38 has an upper surface 39 which lies in a plane above transverse pivot axle 36 and has protruding perpendicularly downwards into upper surface 39 a swivel pin bore 40 which is disposed perpendicularly to and radially outwardly from the transverse pivot axle, midway between opposite transverse sides 41 L, 41 R of bushing member 33 located at opposite longitudinal ends thereof. Swivel bore 40 rotatably holds a swivel pin 42 which protrudes radially outwardly from a lower edge 43 of upper, secondary mirror frame 27 . With this arrangement, secondary mirror frame 27 is pivotable above transversely disposed pivot axle 36 , and swivelable in orthogonally disposed, radial swivel pin bore 40 , as shown in FIGS. 8 and 10 . As shown in FIGS. 6A , 7 A, 7 D, 8 B, and 8 C, primary mirror frame 25 includes in an outer peripheral portion which borders primary mirror 26 a rearwardly or inwardly concave annular ring-shaped lamp channel 44 in which is mounted a circular ring-shaped, tubular lamp 45 , which is preferably a cold-cathode, fluorescent lamp. As shown in FIGS. 6A , 8 A, and 8 B, lamp channel 44 has a generally flat, annular, ring-shaped cover window 46 which has light transmissive and preferably partially light-diffusive. In a preferred embodiment, primary mirror 26 has a concave, spherically-shaped reflective surface 47 which has a radius of curvature selected to yield a desired magnification factor, e.g., between about 5× and about 9×. Although the dimensions of lamp channel 44 are not critical, the radial width of the channel in an example embodiment of travel mirror 20 was about ¾ inch. As shown in FIGS. 6A , 7 A and 7 B, primary mirror 26 is mounted within a rearwardly concave, generally spherically contoured cavity 48 formed in the front surface of primary mirror frame 25 , concentrically located with respect to lamp channel 44 , by any suitable means, such as thin strips of tape 49 coated on both sides with a pressure sensitive adhesive and located between an outer annular portion 50 of rear surface 51 of the mirror, and an annular shoulder ledge 52 which protrudes radially inwardly of the outer circumferential wall of the cavity. As shown in FIGS. 6A and 7B , shoulder ledge 52 is recessed inwardly or rearwardly of outer circumferential edge 53 of primary mirror frame 25 , sufficiently far to locate the front surface 54 of primary mirror 26 inwardly or rearwardly of annular lamp channel cover window 46 , thereby preventing contact between the front surface of the primary mirror with the front surface 55 of secondary mirror 28 , when secondary mirror frame 27 is pivoted to overlie the primary mirror, as shown in FIG. 1 . Referring to FIG. 6A , it may be seen that secondary mirror 28 has a circular shape, and may have a spherical concave surface which has a different radius of curvature than that of primary mirror 26 , but preferably has less curvature and thereby a smaller magnification factor. In a preferred embodiment, mirror 28 has an infinitely large radius of curvature, i.e., is flat, and thus has a “1×” or unity magnification factor. As shown in FIGS. 6A , 7 E, 7 F, and 11 , secondary mirror frame 27 has a shape approximating that of a thin circular plate which has a flat front surface 56 and a convex, arcuately curved rear surface 57 which has a slight curvature. Front surface 56 of secondary mirror frame 27 has formed therein a concentric, circular shallow recess 58 which has a circular bottom wall 59 and a cylindrically shaped peripheral wall 60 . Recess 58 has an outer circumference 61 sufficiently smaller than that of the outer circumferential edge 62 of secondary mirror frame 27 to form therebetween an annular ring-shaped bezel 63 which has a radial width approximately equal to or slightly less than that of annular ring-shaped cover window 46 of primary mirror frame 25 , e.g., about ⅝ inch. According to the invention, at least bezel portion 63 of secondary mirror frame 27 is made of a light transmissive material. In a preferred embodiment, frame 27 is fabricated as a unitary molded part from a transparent material such as a polycarbonate or acrylic polymer plastic. Secondary mirror 28 is retained within recess 58 of frame 27 by any suitable means, such as pressure sensitive adhesive 64 between rear surface 65 of the secondary mirror and upper surface 66 of bottom wall 59 of the recess. Referring to FIGS. 6A , 7 E, and 7 F, it may be seen that secondary mirror frame 27 has a sector-shaped notch formed in outer circumferential edge 62 thereof, thereby forming a straight edge wall 67 lying along a chord of the outer circumferential edge, the edge wall being bisected by a radius of the frame. Chordal edge wall 67 of secondary frame 27 has a flat outer peripheral surface 68 which is perpendicular to flat front surface 56 of the frame, and has protruding radially inwardly therefrom a tapered bore 69 in which is fixed swivel pin 42 . As explained above, the outwardly protruding, lower portion 42 of swivel pin 42 is rotatably held within swivel bore 40 of hinge coupler 29 . FIGS. 1A–21 4 , 5 and 9 – 14 illustrate details of base 21 , handle 22 , and handle pivot joint 23 of travel mirror 20 according to the present invention. As shown in those figures, base 21 preferably includes an upper upwardly concave base half shell 70 , and a lower 27 downwardly concave base half shell 71 , each of which has in plan view a longitudinally elongated oblong shape with arcuately curved transverse end walls. Thus, upper half shell 70 has an upper wall 72 which has protruding downwardly therefrom a flange wall 73 which includes straight left and right parallel longitudinally disposed side wall segments 74 , 75 and front and rear convex arcuately curved transverse end wall segments 76 , 77 , respectively, which are each symmetrically shaped about a longitudinal vertical center plane of the base, and symmetrically shaped with respect to one another through a transversely disposed central mirror plane of the base. Similarly, lower base half shell 71 has a lower base wall 82 which has protruding upwardly therefrom a flange wall 83 which includes straight left and right parallel longitudinally disposed side wall segments 84 , 85 and front and rear convex arcuately curved transverse end wall segments 86 , 87 , respectively, which are each symmetrically shaped about a longitudinal vertical center plane of the base, and symmetrically shaped with respect to one another through a transversely disposed central plane of the base. As shown in FIGS. 5 and 6E , upper half shell 70 has formed in upper surface 72 U of upper wall 72 thereof a relatively wide, longitudinally elongated rectangularly-shaped handle groove 87 located centrally between left and right side walls 74 , 75 of the upper half shell. Referring now to FIGS. 9–14 , it may be seen that upper and lower half shells 70 , 71 have inner concave spaces 90 , 91 , respectively, which, when the half shells are fastened together, form an elongated hollow interior space 92 . Concave inner space 90 of upper half shell 70 contains a battery compartment 93 which is adapted to hold four AA dry cells connected in series with a pair of positive and negative output lead wires 94 , 95 which are connected in parallel with a battery eliminator jack 96 mounted in a vertically opposed pair of upper and lower slots 97 , 98 of upper and lower half shells 70 , 71 , the jack protruding rearward through upper and lower U-shaped half apertures 99 , 100 in rear transverse end walls 77 , 87 , respectively, of the upper and lower half shells. Positive and negative output lead wires 94 , 95 are also connected through a switch 101 to power input terminals of a d.c.-a.c. inverter 102 , which has a pair of high-voltage a.c. output lead wires 103 , 104 which thread through the bore 105 of a diametrically split axle bushing 106 located at a transverse end of a handle pivot axle 107 located at the lower end of handle 22 , and thence to electrodes 108 , 109 of lamp 45 . As shown in FIGS. 2 and 12A , bottom half shell 71 of base 21 has a longitudinally disposed battery compartment access door 110 frictionally held within a longitudinally elongated, rectangularly shaped battery compartment access port 111 by a resilient plastic folded leaf-shaped self-spring latch 112 molded integrally with the access door, which is vertically aligned with battery compartment 93 . Preferably, base wall 82 of lower half shell 71 also has through its thickness dimension a pair of longitudinally spaced apart, front and rear laterally disposed mounting holes 113 F, 113 B which each have generally circularly shaped center portion 114 and a pair of diametrically opposed radially outwardly protruding, mirror symmetric slots 115 for slidably receiving the shank of mounting screw (not shown) screwed into a wall which has a head (not shown) insertable into the center portion of the mounting holes, thereby enabling travel mirror 20 to be removably mounted onto a wall by a pair of vertically disposed screws. Referring to FIGS. 12A-14 , it may be seen that handle pivot axle 107 located at a lower end portion of handle 22 has a generally cylindrical shaped major body portion 116 which is disposed transversely between opposite left and right vertical sides 117 L, 117 R of the handle. Pivot axle 107 includes at one side of, e.g., the left side, a bushing 106 of smaller diameter than body 116 of the axle which protrudes axially, i.e., perpendicularly outwards from left transverse face end 119 of the axle body. Also, pivot axle 107 has protruding from an opposite, e.g., right transverse side thereof, a cylindrically shaped boss section 120 which has a diameter approximating that of main axle body 116 . Cylindrical boss section 120 of axle 107 has formed in outer cylindrical wall surface 121 thereof a rectangular cross-section, circumferential annular groove 122 , an inner transverse end wall 123 of which is located adjacent to right vertical side wall 117 R of the handle. Boss section 120 also has a cylindrically shaped axially outwardly located end portion 124 which extends from an outer transverse end wall 125 of groove 122 . Outer cylindrical end portion 124 of right-hand cylindrical boss section 120 of handle pivot axle 107 has a transversely disposed, outer circular end face 125 , which has protruding perpendicularly outwards therefrom a concentrically located stud 126 which has a generally rectangular transverse cross section. Referring still to FIGS. 12A-14 , it may be seen that upper and lower base half shells 70 , 71 have formed in front portions of inner opposed concave faces 127 , 128 thereof transversely disposed, generally semi-cylindrically shaped upper and lower grooves or channels 129 , 130 , respectively, which, when the half shells are secured together, form a generally cylindrically-shaped cavity 131 for rotatably receiving cylindrically-shaped handle pivot axle 107 . Thus, as shown in FIGS. 9–11 , lower base half shell 71 has protruding upwardly from lower base wall 82 thereof a laterally centrally located, generally semi-cylindrically-shaped pivot axle groove 132 which has a front upper wall 133 adjacent to front transverse end wall 86 of the base shell. Pivot axle groove 132 has a rear edge wall comprised of a thin, arcuately curved web 134 which protrudes upwardly from the upper surface 135 of lower base wall 82 , and a lower wall surface 135 comprised of a semi-cylindrically contoured groove formed in the upper surface of the lower base half shell. As shown in FIG. 12H , lower curved wall surface 135 of semi-cylindrical pivot axle groove 132 preferably has protruding downwardly therefrom a laterally elongated, rectangularly-shaped shallow recess 136 in which is mounted a rectangularly-shaped friction pad 137 that is made of a material such as silicone rubber which has a relatively large surface coefficient of sliding friction. As shown in FIGS. 12H , pivot axle groove 132 has left and right U-shaped, transverse end journals 138 , 139 located at left and right ends thereof, respectively, of the groove. The end journals 138 , 139 are comprised of generally uniform-thickness, transversely disposed U-shaped webs 140 , 141 which protrude perpendicularly upwards from upper surface 135 of lower base wall 82 of lower half shell 71 . Left and right end journals 138 , 139 have formed in upper surfaces thereof left and right downwardly concave semi-cylindrically-shaped grooves 142 , 143 which are of a suitable size and lateral spacing from one another to rotatably receive the left-hand bushing 106 and right-had groove 122 of right-hand cylindrical boss section 120 , respectively, of handle pivot axle body 116 . As is also shown in FIG. 12H , lower base half shell 71 also includes a generally semi-cylindrically shaped, axial friction control groove 144 which is adjacent to the outer, right-hand transverse face 145 of right-hand handle pivot axle body journal 139 . Friction control groove 144 is coaxially aligned with lower semi-cylindrical pivot axle groove 132 , and preferably of smaller diameter and length. Also, friction control groove 144 has located at a right transverse end thereof a short semi-cylindrically shaped nut holder groove 146 which has a polygonal transverse cross-section and which is adapted to irrotatably hold a hex nut 147 . Nut holder groove 146 has an outer, right-hand transverse end journal 148 which has the form of a U-shaped web 149 that has in an upper surface thereof a groove 150 adapted to rotatably receive the shank 151 of a friction adjustment screw 152 which has located at the outer end thereof, a fluted friction-adjustment knob 153 . Also, the inner, left-hand transverse end of nut holder groove 146 is bordered by a U-shaped left-hand end journal 154 comprised of U-shaped web 155 which protrudes upwardly from upper surface 135 of lower base wall 82 of lower half shell 71 . Left-hand nut groove journal 154 has formed in upper surface 156 of web 155 thereof a downwardly concave semi-cylindrically shaped groove 157 which is of a suitable size to provide clearance for and therefore allow free rotation of screw shank 151 . Referring still to FIG. 12H it may be seen that outer, left-hand transverse face 158 of left-hand nut groove journal 154 has protruding axially outwards therefrom a pair of generally rectangularly-shaped, vertically disposed front and rear end spacer ribs 159 F, 159 B, which are spaced equal distances radially outwards from front and rear sides of journal groove 157 . Outer, left-hand face 158 of left-hand nut groove journal 158 also has protruding axially outwards from a lower base portion thereof a low, rectangular cross-section, slider rib 160 which protrudes upwardly from the center of lower semi-cylindrical wall surface 161 of friction control groove 144 . As shown in FIGS. 9 and 10 , slider rib 160 protrudes upwardly into a longitudinally disposed lower groove 162 L formed in the outer cylindrical surface 163 of a cylindrically-shaped slider bushing 165 which is longitudinally slidably located in axial friction control groove 144 . As shown in FIGS. 12A–14 , slider bushing 165 has formed in outer cylindrical surface 163 thereof upper and lower longitudinally disposed, diametrically opposed, rectangular cross-section grooves 162 U, 162 L, respectively. Slider bushing 165 has a transversely disposed circular, flat outer or right-hand end face 166 , and a circular left-hand transverse face in which are formed axially inwardly protruding rectangular cross-section vertically disposed transverse grooves 167 U, 167 L which are continuous with upper and lower longitudinal grooves 162 U, 162 L, and a pair of radially disposed front and rear transverse grooves 168 F, 168 B which are perpendicular to the vertically disposed grooves. All of the above-identified end face grooves radiate from a coaxially centrally located blind bore 169 which protrudes inwardly from outer, left-hand transverse face 170 of slider bushing 165 . Bore 169 is provided for receiving stud 126 which protrudes outwardly from boss 120 of handle pivot axle 107 . The function of end face grooves 167 U, 167 L, 168 F, 168 B is to facilitate elastic deformation of bushing 165 in response to longitudinal forces exerted on the bushing. As shown in FIGS. 12A–14 , friction control groove 144 longitudinally slidably holds in axial alignment with slider bushing 165 a circular rubber washer 171 , which is preferably sandwiched between a pair of outer and inner circular plastic washers 172 O, 172 I, all of which have a diameter approximating that of the slider bushing and slightly less than that of the friction control groove. Each of the washers is provided with central coaxial through-bore. The inner transverse face 173 I of inner plastic washer 172 I adjacent to outer circular end face 126 of right-hand cylindrical boss section 120 of handle pivot axle 107 is pressed against the right-hand end face of the handle axle boss section with an axial force which is adjustable by turning friction control knob 153 . Turning friction control knob 153 in a direction which advances friction adjustment screw shank 151 towards the handle pivot axle increases the axial frictional force exerted on the pivot axle to resist pivotable motion of the handle relative to the base; turning the control knob in the opposite direction retracts the screw shank to thereby reduce frictional resistance to pivotable motion of the handle. Referring to FIGS. 12A–14 , it may be seen that upper base half shell 70 has formed therein an upwardly concave generally semi-cylindrically shaped, transversely disposed upper half shell channel 129 that has several structural elements which have shapes complementary to those of elements of the lower half shell which were identified and described above. Those upper and lower structural elements are mirror symmetrical through a horizontally disposed joint plane between upper and lower base half shells 70 , 71 and cooperate to form generally cylindrically shaped cavities. Thus, for example, upper base half shell 70 has left and right transverse end journals 188 , 189 , which mate with lower base half shell journals 138 , 139 , the semi-cylindrically shaped grooves 142 , 143 of the lower journals mating with semi-cylindrically shaped grooves 192 , 193 of the upper half shell journals to form closed, cylindrically shaped pivot axle body end journals 292 , 293 , respectively. Similarly, upper base half shell 70 has formed therein an upper semi-cylindrically shaped friction control groove 194 which forms with lower semi-cylindrically shaped friction control groove 144 of lower base half shell 71 a cylindrically shaped friction control cavity 293 . Upper base half shell 70 also includes a semi-cylindrically shaped upper nut holder groove 196 which is bordered on right and left ends thereof by right and left upper nut groove journals 198 , 204 , forming with corresponding lower right and left journals 148 , 154 , respectively, a closed, cylindrically shaped nut holder cavity 296 . Referring still to FIGS. 12A–14 , it may be seen that upper base half shell 70 has protruding downwardly from the upper inner surface thereof spacer ribs 209 F, 209 B and a slider rib 210 which are mirror images of ribs 159 F, 159 B, and 160 , respectively, of lower base half shell 71 . As shown in FIGS. 12A–14 , upper base half shell 70 has protruding rearwardly from front edge wall 221 thereof an elongated, rectangularly-shaped notch 222 which is laterally symmetrically located with respect to the left and right side walls 223 L, 223 R of the upper half shell. With upper and lower base half shells 70 , 71 fastened together, notch 222 is vertically aligned with semi-cylindrically shaped pivot axle groove 132 , and enables handle pivot axle 107 to rotate from an angular orientation in which handle 22 is received in handle groove 87 in the upper surface of the upper half shell, in a compact storage/transit configuration, to an upright use configuration in which the handle is angled upwardly from base 21 , as shown in FIGS. 11 and 14 . FIGS. 15A through 21 illustrate structural elements of mirror device 20 which enable telescopic adjustment of dual mirror assembly 24 of mirror device 20 to a desired height relative to base 21 . As shown in those figures, handle 22 of mirror 20 has a vertically elongated, generally rectangular plan-view front portion 224 which has a shape approximating that of rectangular cross-section channel member or shell which includes a front vertically elongated rectangular front base plate member 225 , and rearwardly protruding left and right flange walls 226 L, 226 R. Front handle portion 224 has a rearwardly curved, transversely disposed lower end portion 227 which is coextensive with front, upper half 228 of handle pivot axle 107 . Also, handle 22 has a rear rectangular plate-shaped panel 229 which is secured within a longitudinally disposed channel 230 in the rear side of front handle shell 224 , and has located at a lower end thereof a transversely disposed, generally semi-cylindrically shaped extension 231 which mates with semi-cylindrically shaped lower end 227 of front handle shell 224 to form cylindrically-shaped handle pivot axle 107 . Handle 22 fits telescopically slidably within an elongated rectangular bore 232 within an elongated generally rectangularly-shaped handle boss tube 233 which protrudes rearwardly from rear surface 234 of primary mirror frame 25 , the handle boss extending vertically along a diameter of the mirror frame, centered on a diameter thereof. As shown in FIGS. 6A , 7 A– 7 D and 15 – 19 , bore 232 of handle boss tube 231 has mounted in a front or bottom longitudinally disposed base wall thereof a generally rectangularly-shaped, longitudinally elongated detent plate 235 . Detent plate 235 has located in rear surface 236 thereof a plurality of a longitudinally spaced apart, laterally disposed detent grooves 237 . As is also shown in FIGS. 15A and 16 , front base plate member 225 of front handle shell 224 has an upper transversely disposed edge wall 238 which has protruding perpendicularly inwardly therefrom a pair of parallel, longitudinally disposed left and right slots 239 L, 239 R which are spaced equal distances to the left and right, respectively, of a longitudinally center plane of the handle shell. Slots 239 L, 239 R form therebetween a rectangularly-shaped tab 240 , which is flexibly and resiliently joined at a rear transverse edge 241 thereof to a longitudinally inwardly located portion of the front base wall plate 225 by an elastically deformable self hinge 242 , resulting from front wall plate 225 being made of an elastically deformable polymer such as polypropylene. Tab 240 has protruding downwardly or forwardly from a front edge wall 243 thereof a laterally disposed, radiused detent rib 244 . Detent rib 244 is of the proper size and shape to snap resiliently into a particular one of detent grooves 237 that it becomes aligned with as primary mirror frame 25 is moved longitudinally with respect to handle 22 . With rib 244 resiliently engaged within a detent groove 237 , a relatively large longitudinal force must be exerted on handle 22 relative to primary mirror frame 25 to disengage the rib from the groove. Thus constructed, primary mirror frame 25 is telescopically extendible and retractable with respect to handle 22 , to an adjustable length or height relative to base 22 , the adjusted height being maintained by cooperative action of the detent rib and a detent groove.

1a

CROSS-REFERENCES [0001] The present application claims the benefit of priority to U.S. Provisional Application No. 61/471,714 (filed 5 Apr. 2011), which is incorporated by reference herein. TECHNICAL FIELD [0002] The present invention relates to surgical lighting systems. BACKGROUND OF THE INVENTION [0003] It is generally believed that it would be desirable to produce a surgical lighting system that can eliminate the need for a surgeon or scrub nurse to manually move a surgical light with their hands to provide focused lighting at the surgical site. Such a system would prevent undue contamination of instruments as a result of transfer of bacterium from lamp handles, allow surgical personnel to focus their attention to more important tasks such as instrument passing, and alleviate the need for low-hanging, reachable lamp handles which may obstruct the surgical flow. [0004] There exist several different approaches to alleviate this problem. U.S. Pat. No. 5,093,769 by Luntsford discloses a surgical lighting system which is remotely controlled by surgical personnel. This system is also capable of “recording” a sequence of lamp configurations which can be “played back” during time of surgery. Another solution as disclosed in U.S. Pat. No. 6,560,492 by Borders describes a system which can control several aspects of operating room function such as: patient table movement, temperature control, and lighting intensity. The solution by Luntsford eliminates the need for surgical personnel to manually move surgical lamps by allowing them to remotely control the lamps, but does not totally eliminate the need to have surgical personnel to initiate such movements, and is therefore only semi-automatic. The solution by Borders suffers from a similar downside, as a user is required to control the disclosed system. Border's solution offers to modulate the intensity of the surgical lights, but does not allow for movement of said lights. [0005] The system disclosed in U.S. Pat. No. 6,642,836 by Wang et al discusses a device which utilizes voice recognition to control various machines in the operating room including lights. However this system still requires a surgeon or assistant to initiate the lamp movement using their voice, and is thus only semi-automatic. Also, the voice recognition system introduces the complication of voice-recognition which may not always be accurate. SUMMARY [0006] The present invention provides illumination for a surgical procedure. Using an optical tracking system, the illumination is made to automatically track an optical marker on a surgical glove worn by a clinician to provide more consistent illumination for a surgical procedure. [0007] The present invention uses a surgical glove that comprises an optical marker that can be detected by an optical sensor. The optical marker may be an active optical marker that emits light in any suitable wavelength range, including infrared. Any suitable light-emitting source may be used. For example, the optical marker may be a light-emitting diode (LED). This active optical marker can be switched on or off when desired by the user (such as a surgeon). Alternatively, the optical marker may be a passive marker that reflects light received from an external source. In some cases, the passive marker may be an infrared reflector. [0008] In one embodiment, the present invention provides a surgical lighting system that comprises a lighting apparatus. The lighting apparatus comprises a movable platform and an illumination source on the movable platform. The illumination source provides visible light for performing surgical procedures. The movable platform can be moved to change the direction of the illumination. The lighting apparatus further comprises a motor for moving the movable platform to change the direction of the illumination source. There is a controller operably coupled to the motor and an optical sensor operably coupled to the controller. The automatic operation of the surgical lighting system can be switched on or off by two methods: (a) Switching on or off the controller of the lighting apparatus; or (b) Switching on or off the active optical marker. [0009] The optical sensor detects the light emitted or reflected by an optical marker on a surgical glove. The controller operates the motor based on information received from the optical sensor to direct the illumination source towards the glove. [0010] The controller may use any suitable tracking, searching, or positioning algorithm. For example, the lighting apparatus may comprise an array of sensors (e g infrared sensors) surrounding the illumination source and arranged in a radial and equidistant pattern from a fixed point. The general direction of movement or placement of the optical marker on the gloved hand can be determined by reading the intensity values and determining the largest intensity value from the array of sensors. In response to the sensor readings, motors on the lighting system move the platform so that the illumination source points in the direction corresponding to the sensor giving the highest intensity reading. [0011] In embodiments where the optical marker on the glove is an infrared reflector, the system may rely on an infrared source on the lighting apparatus for providing the infrared emissions. The infrared source may be the same as the illumination source (e.g. the illumination source includes infrared emissions) or a separate component of the lighting apparatus. [0012] In another embodiment, the present invention provides a method of providing illumination for a surgical procedure. The method comprises providing a lighting apparatus of the present invention. The method further comprises providing either (a) a surgical glove and an optical marker for attaching to the glove, or (b) a surgical glove comprising an optical marker. The optical sensor detects the light emitted or reflected by the optical marker on the surgical glove. The controller operates the motor based on information received from the optical sensor to direct the illumination source towards the glove. [0013] In another embodiment, the present invention provides a method of performing a surgical procedure. In this method, the clinician places a surgical glove that comprises an optical marker on a hand. The clinician moves the gloved hand while performing the surgical procedure. The method further comprises using a lighting apparatus of the present invention. The optical sensor detects the light emitted or reflected by the optical marker on the surgical glove. The controller operates the motor based on information received from the optical sensor to direct the illumination source towards the glove. [0014] In another embodiment, the present invention provides a room for performing a surgical procedure. The room comprises a surgical bed or chair; a surgical glove comprising an optical marker, or a surgical glove and separately, an optical marker for attaching to the glove. The room further comprises a lighting apparatus of the present invention. The optical sensor detects the light emitted or reflected by an optical marker on a surgical glove. The controller operates the motor based on information received from the optical sensor to direct the illumination source towards the glove. [0015] The lighting apparatus is positioned so that it can be directed towards the surgical bed or chair. For example, the lighting apparatus may be fixed to the ceiling, wall, or floor of the room so that it can be directed towards surgical bed or chair. [0016] In another embodiment, the present invention provides a surgical glove comprising an optical marker. Being a surgical glove, the glove may have one or more of the following characteristics: sterile, elastic, conforms tightly to a person's hand, made of latex or other elastic material, and/or impermeable to body fluids (such as blood, saliva, urine, wound exudate, mucous, etc.). The surgical glove may be used for any suitable medical procedure, including surgical, dental, obstetric, gynecological, and/or dermatological applications. As used herein, surgical procedures include surgical, dental, obstetric, gynecological, veterinary, and/or dermatological procedures. [0017] In another embodiment, the optical marker can be placed on bare hands for other uses. In another embodiment, the glove is not necessarily a surgical glove. For example, the glove could be for semiconductor or industrial uses. [0018] The optical marker may be part of the glove in any suitable way, such as being embedded in the glove, attached to the glove, or part of the glove as a single unitary article. Alternatively, the optical marker may be provided separately for the user to attach to the glove. For example, the optical marker may be an adhesive patch that can be attached to the glove. In one particular example, the optical marker may be an infrared-reflective adhesive patch that can be attached to the outer surface of the glove (e.g. surface for the back of the hand). In another example, an active optical marker could have an adhesive surface for attachment to any surface including the surgical glove. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 illustrates the automated surgical illumination system according to the present invention. [0020] FIG. 2 illustrates to the cone attached to the lower arm of the surgical illumination system as an example of the invention. [0021] FIG. 3 shows an example lighting apparatus of the present invention. [0022] FIG. 4 shows an example illumination source and camera of the present invention. [0023] FIG. 5 illustrates a functional schematic diagram of the surgical illumination system in which the invention may usefully practice. [0024] FIG. 6 illustrates two examples of an optical marker used in the present invention. [0025] FIG. 7 illustrates an example of a switch that can activate and deactivate an active optical marker. DETAILED DESCRIPTION [0026] FIG. 1 and FIG. 2 illustrate an automated surgical illumination system according to one embodiment of the present invention. The base 1 of the device is to be mounted to the ceiling. Attached to the base 1 is the upper arm segment 3 . The upper arm segment 3 rotates 360 degrees both clockwise and counterclockwise on its axis within base 1 . Upper arm segment 3 is able to rotate in said manner when motor 2 is turned on in either direction. Attached to the upper arm segment 3 at hinge 5 is lower arm segment 6 . Lower arm segment 6 rotates 180 degrees both clockwise and counterclockwise at hinge 5 . Lower arm segment 6 is able to rotate in said manner when motor 4 is turned on in either direction. At the end of lower arm attaches a third motor 7 that gives the cone the third range of motion. The lamp reflective cone 8 also functions as a stage for several sensors 9 mounted to the cone 8 to form a sensor array. The light source 10 is affixed and centered inside the reflective cone 8 . [0027] An LED emitter (active optical marker) 11 is embedded in a surgical glove worn over the hand. A switch 12 connects and disconnects power to the LED emitter and is worn at a location on the surgeon's hand or body. The said gloved hand is placed underneath the reflective cone 8 , which also functions as the sensor array stage. [0028] FIG. 3 and FIG. 4 illustrate another embodiment of the present invention using a passive optical marker. The lamp reflective cone 8 houses several infrared (IR) LEDs 14 and a camera with IR pass filter 15 . The light source 10 is affixed outside the IR LEDs 14 and a camera with IR pass filter 15 . [0029] An IR-reflective patch 13 is embedded in a surgical glove worn over the hand. The IR-reflective patch 13 reflects the light in the IR wavelength emitted by IR LEDs 14 . The camera with IR pass filter 15 then senses the position of the IR-reflective patch. [0030] FIG. 5 is a functional schematic diagram of the automated surgical illumination system according to the present invention. This diagram should be taken exemplary of the type of device in which the invention may be embodied, and not as limiting, as it is believed that the invention may usefully be practiced in variety of device implementations including instances where the surgical light is desired to be fixated on a point, thus only tracking when the surgeon initiates tracking. User input comprising of an optical marker (e.g. IR source or IR LED) is detected by the sensor (e.g. IR sensor), which is mounted with the light. The detection in terms of voltage is connected to the input of the microprocessor. Microprocessor makes a calculation and makes a decision whether or not the sensor is centered on the IR source. If the microprocessor makes a decision that the IR sensor is centered on the optical marker, then, the activation of motor stops. However, if the microprocessor decides that the IR sensor is not centered on the optical marker, the motors are activated to center the sensor on the optical marker. [0031] FIG. 6 shows two examples of an optical marker used in the present invention. In one example, an LED emitter (active optical marker) 11 is embedded in a surgical glove worn over the hand in which a switch 12 activates and deactivates the active optical marker 11 . In another example, an IR-reflective patch 13 (passive optical marker) attaches to the surgical glove worn over the hand and does not have a switch. [0032] FIG. 7 illustrates an example of a switch 12 in its on and off position. This switch controls whether the active optical marker is activated or deactivated.

1a

This invention relates to furniture. In particular, it relates to small step stools convertible to more than one configuration. BACKGROUND AND SUMMARY OF THE INVENTION Small step stools are commonly needed in households, most of which contain at least a few storage areas located too high from the floor for easy access. In particular, when there are small children present in the home, such stools may be needed in areas such as bathrooms and other sink or counter facilities to render such facilities accessible while the children are growing up. Such a stool should ideally be able to be moved easily to and from the floor in front of a sink so that the area can also be used by the persons of normal height. In addition, it must of course be entirely stable against sidewise motion while in use. An ordinary short stool, with its legs cut to the necessary height, may be employed. It must, however, be transported to and from the site of use, and may not be stable enough for a very young child. One kick stool, of known design, is easy to transport because it rolls readily across the floor with a kick and becomes stable when stepped upon. However, it occupies space on another area of the floor, which can be a problem in small quarters such as a bathroom. The present invention obviates these difficulties. It is a stool which has two major parts. By reassembling the parts it can be used either as a free-standing stool of traditional design and useful height, or instead, as a folding stool. When in the folding stool configuration, one part is fastened to the lowest shelf in the typical sink cabinet while the other part, pivoting outward from the first part, can be pulled out by a child for temporary use as a stool. The vertical relationship between the parts is adjustable for adapting the device to the cabinet shelf height. When the child has grown to the point that the folding stool is unnecessary at the sink or counter, it may be removed altogether from its mounting in the cabinet, and reassembled easily into the free-standing configuration for general household use, or for the child's use in reaching high shelves. Accordingly, it is an object of the invention to provide a supporting stool for lifting a small child to the necessary level for use of a sink or countertop atop a base cabinet. A further object of the invention is to provide such a stool which is stably mounted against sidewise motion but which can easily be moved away from the standing site so the area can be used by others. Another object of the invention is to provide such a stool which may be converted into a single free-standing step stool when no longer needed at the cabinet. Other objects and a fuller understanding of the invention will be apparent from the claims herein, the accompanying specification, and the description to follow of a preferred embodiment taken together with the figures, in which: FIG. 1 a perspective drawing of the stool of the present invention, assembled or configured as a free-standing step stool. FIG. 2 is a perspective drawing of the stool configured as a fixed folding step stool. FIG. 3 is a plan view of the stool of FIG. 1. FIG. 4 is a side elevational view of the same stool, exploded into its two major parts. FIG. 5 is a front elevational view partly in phantom section, of the same stool. FIG. 6 is a side elevational view of the stool as configured in FIG 2. FIG. 7 is another side elevational view, partly in phantom section, of the stool as configured in FIG. 2, except that the assembly is adjusted with a different vertical relationship between the members. FIG. 8 is a further side elevational view of the stool of FIG. 7, shown in the folded portion. FIGS. 9a, 9b and 9c are perspective views showing the disassembly of the configuration of FIG. 1 and the stool's reassembly into the configuration of FIG. 2. DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1 and 2 show in perspective the two ways of configuring the parts of the present invention. In FIG. 1, a free-standing stool is shown, and in FIG. 2 a folding stool which has a supporting member attached to a step or the lowest shelf of a cabinet. The free-standing stool of FIG. 1 as also seen in FIGS. 3, 4, 5 and 9a comprises two essential parts. As best seen in FIGS. 3, 4 and 9a, a platform member 10 is supported by an interlocking supporting member 20, by means of four 1/4 inch machine screws 31, 32, 33 and 34. The fastening means could of course be any similar means such as bolts, or could comprise instead two long fasteners extending through the platform member 10. Screw 31 is inserted through hole 11 in platform member 10 and hole 21 in supporting member 20, screw 32 through holes 12 and 24, and similarly on the other side, not shown. As best seen in FIGS. 8, 9a, 9b and 9c, supporting member 21 is provided with recesses 25, 26 and 27 to permit interlocking and enable it to be fastened to a shelf by screws. The folding stool configuration shown in FIG. 2 is shown in more detail in FIGS. 6, 7, 8 and 9c. In this configuration the supporting member 20 has been inverted with respect to platform member 10, and rotated through ninety degrees. It has been fastened to a shelf 40, and then screwed to platform member 10 through hole 12 and the corresponding hole on the other side. FIGS. 6 and 7 illustrate two versions of this configuration, differing only by the choice of which of holes 21, 22, 23 or 24 on supporting member 20 is selected for assembly to platform member 10. This choice will be determined by the height of shelf 40 from the floor. This reconfiguration is best seen in FIGS. 9a through 9c. The conversion to a folding stool is easily effected by removing the four screws 31 through 34 and separating the members as shown in FIG. 9a. The supporting member 20 is inverted and its desired position on the base counter shelf marked with a pencil through holes in its outer wall. These holes may be provided in the supporting member at manufacture, but it is preferred to mold indents into the member, which indents are used to located holes drilled just before installation. Generally a clearance of 1/2 inch between the edge of shelf 40 suffices to permit closing of the cabinet door, but this will be adapted according to the cabinet itself in an obvious manner. When supporting member 20 is screwed to shelf 40, the one of holes 21, 22, 23 or 24 is chosen which best levels platform member 10 with the floor. It has been found that holes about 1/2 inch apart will suffice for adequate leveling in the preferred embodiment. Each side is fastened with one screw, tightened enough to hold securely but just loose enough to permit pivoting of the members 10 and 20 with respect to each other. FIG. 8 shows the step stool in the closed position. In the preferred embodiment, the members are blowmolded plastic with an average wall thickness of 0.08" to 0.10". The height of the platform member, which is slightly domed on top for strength, is 8.7 inches from the floor. A 3 3/4 inch space between the legs on each member provides a convenient handle area for easy lifting of the stool, or pivoting of the platform member when in the second configuration. A rubber foot is securely screwed to the bottom of each leg to help prevent slipping when the stool is in the free-standing form. As seen best in FIGS. 6, 7, 8 and 9b, recesses are provided for easy clearance during the marking, drilling and mounting operations. In the preferred embodiment, screw holes 21 through 24, and their counterparts on the other side of the supporting member, are contained in a separate insertable molded plastic member provided with an integral plastic flap or "living hinge" for best appearance. The principal use for the folding step stool will be as described, for supporting a child at a convenient height from the floor in front of a base cabinet. It will of course be recognized, however, that the same kind of arrangement will suffice to hold any object away from a first horizontal surface, where there is a second surface present to which the supporting member may be fastened. The essential point of the invention is its re-configurability between the free-standing and the fastened down, but folding, forms of the stool. The invention has been described in detail with particular emphasis on the preferred embodiments thereof, but it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains.

1a

This is a division of application Ser. No. 280,542 filed Aug. 14, 1972, now U.S. Pat. No. 3,882,026. BACKGROUND Parenteral solutions such as normal saline, 5% dextrose, etc., are commonly infused into a patient's vein to replenish liquid and correct electrolyte imbalances. This is often done with a 1-liter bottle suspended mouth downwardly above the patient and liquid flows by gravity from the bottle and through a flexible administration line connected to the bottle and then through a needle inserted into the patient's vein. The bottle of parenteral solution being infused into the patient has been sterilized either at the manufacturer of the bottled solution or at the hospital where hospitals make up their own solutions. Likewise the tubular administration set connected to the bottle has also been sterilized. While the solution, bottle and administration set are sterile, the solution might pick up a minute amount of sterile particulate matter in the micron size range. These particles could come from various sources such as the bottle, closure, or inner surface of the administration set. In the past it has been proposed to place a so-called "final filter" at a lower end of the administration set immediately before it enters the venous needle and the patient's vein. While it would be desirable to filter out all sterile particulate matter regardless of how infinitesimally small, as a practical matter filters that would not pass any particles at all also would not pass liquid. With a working practical filter it is desirable to filter out 90 percent or more of all the sterile particulate matter 5 micron or above in size from a sterile parenteral solution. The problem with previous filters that filtered out 90 percent of all particulate matter 5 micron or above size was the physical size of the filter. These previous filters were roughly the size of a silver dollar and presented a large and cumbersome unit hanging on a needle stuck in the patient's vein. Most of the prior filters were of the "absolute" type, with a series of holes of a given size passing straight through the filter for conducting liquid through the filter while physically blocking particle passage. A woven screen is an example of an absolute filter. Thus to filter out particles of larger than 5 micron the holes must be 5 micron size or smaller. The problem with the absolute filter was that occasionally one hole would be larger than the others and allow some larger particles through. Therefore, an absolute filter rated for 0.45 micron pore size might only filter out 95 percent of all particles of 5 micron and larger. To get liquid to flow through a 0.45 micron related absolute filter a very large surface area was required. An area of 1 inch diameter was not uncommon. Another reason for the large size of prior filters was that they were of hydrophilic or readily "wettable" materials that had an absorbing effect on the liquid. While liquid would pass through such hydrophilic filters, large surface areas were required to get the liquid flow to a rate normally used in intravenous administration. SUMMARY OF THE INVENTION I have overcome the problem of previous "final filters" at the patient's venous needle by providing a filter of substantially smaller size. Instead of an absolute filter of 1 inch diameter I have discovered that very high filtering efficiencies are obtained by passing the parenteral solution through a small filter disc of roughly 1/4 inch in diameter. This tiny filter disc fits into a housing that is very convenient and compact for attaching directly to a venous needle. The filter disc of my invention involves a hydrophobic nonfibrous "depth" filter with interconnecting stacked passages of from 10 to 40 micron size. This is entirely different from "absolute" filters of the past which had only a single layer of holes such as would resemble a woven screen or a plate with a series of straight holes drilled through it. A "depth" filter resembles a piece of bread with a series of interconnecting passages. This "depth" filter is of a hydrophobic material which is commonly used in the medical field to prevent liquid passage while allowing air to pass. Examples of these air-liquid separator filters are described in the Reily U.S. Pat. No. 3,631,654, and Bujan U.S. Pat. No. 3,157,481. I have unexpectedly found that by using relatively large pores of from 10 to 40 micron size in a "depth" filter of hydrophobic material, such as porous polytetrafluoroethylene marketed under the name Teflon (DuPont trademark), liquid can be filtered at very high filtering efficiencies for particles of 5 micron size and above. Normally liquid will not pass through such filter because of the liquid-shunning nature of the material. However, I have discovered liquid flow can be started through the filter by initiating a shock wave, such as a physical tap, to the filter after the filter has had one or more surfaces in contact with the parenteral solution for a period of 15 to 60 seconds. Once liquid starts through this hydrophobic filter an amazing thing happens. More than 90 percent of all particulate matter of 5 micron size and larger in the parenteral solution is filtered out by such hydrophobic filter. This filtering occurs even though the passages are more than twice the size of the 5 micron size. I have found that in measuring and counting the filtered particles from a typical sterile parenteral solution that more than 1/2 of all particles filtered out fall in the 5-20 micron range, when filtering with a depth filter having a pore size of 20 to 30 micron size range. This hydrophobic filter of approximately 1/4 inch diameter fits inside a rigid transparent housing where it is permanently secured by a special hydraulic assembly method and is connected directly to a venous needle. This invention can be better understood with reference to the attached drawings. THE DRAWINGS FIG. 1 is a front elevational view showing the filter device connected to an administration set at the venous needle; FIG. 2 is an enlarged side elevational view of the filter device disconnected from the venous needle and the administration set; FIG. 3 is an enlarged side elevational view of the filter device showing removable protectors on opposite end portions of the device; FIG. 4 is an enlarged exploded cross sectional view showing two parts of a hollow housing that contains the filter discs; FIG. 5 is a sectional view taken along line 5--5 of FIG. 4; FIG. 6 is a further enlarged section view of the filter device shown in vertical position; FIG. 7 is still a further enlarged view showing a rounded tipped support prong engaging one of the filter discs; FIG. 8 is a sectional view taken along line 8--8 of FIG. 6; FIG. 9 is a further enlarged fragmentary sectional view showing the two parts of the housing being telescopically assembled together; FIG. 10 is still a further enlarged fragmentary view showing the two filter discs permanently secured to the filter housing; and FIG. 11 is an enlarged schematic view showing an example of a random path liquid takes in its flow through the "depth" filter discs. DETAILED DESCRIPTION Referring in detail to the attached drawings, FIG. 1 shows the system set up for administering parenteral solutions. The bottle 1 is suspended mouth downwardly from a hanger 2 above the patient. A tubular administration set has a spike 3 that is connected to an outlet of bottle 1. An air tube 4 in the bottle, permits air to enter the bottle as liquid is dispensed through the administration set. The administration set includes a spike 3, a drip housing 5, a flexible tube 6, a roller clamp 7 for controlling flow rates, and a venous needle 8. As shown in FIG. 1, a filter device generally indicated as 9 is connected between a distal end 10 of the flexible tube 6 and the venous needle 8. Thus, as liquid flows from bottle 1 through drip chamber 5 and conduit 6 it must pass through filter 9 before entering venous needle 8. It is to this special "final" filter 9 at the venous needle that this invention relates. The special filter device is shown in an enlarged view in FIG. 2. This filter device includes a hollow housing 11 that has a forward adapter section 12 and a rearward adapter section 13. The forward adapter section 12 has a tapered needle adapter 14 and a protector adapter 15. A protruding rib 16 is used to indicate the direction of needle bevel of a hypodermic needle when attached to tapered adapter section 14. The rear adapter portion 13 includes a series of longitudinal ribs illustrated as 17 and 18. Over these ribs fit and end portion of flexible tube 6. If the filter device is sold preattached to tube 6 it can be permanently bonded to this tube. Otherwise if sold separately the adapter can be telescopically wedged into tube 6. FIG. 3 shows the identical filter device of FIG. 2 with the hollow housing 11. However, here the forward adapter section 12 and the rearward adapter section 13 are covered respectively with removable protectors 19 and 20. If desired, these protectors can be reversed with the longer protector 20 on forward adapter section 12 and the shorter adapter 19 on rearward adapter section 13. Also, if desired the ribs 17 and 18 can be eliminated and a particular protector fitted to the rearward adapter 13 in an air tight fit. In this event a sterilizing vent can be made in through the protector on forward adapter 12. The internal structure of the filter device can best be seen in FIG. 4. Here there is a first hollow body member 21 that includes an enlarged chamber 22 that has an internal wall surface 23 and an internal wall surface 24. As noted in FIG. 4 the internal wall surface 24 is slightly larger than the wall surface 23 so as to provide a shoulder surface 25 therebetween. Directly adjacent an outlet passage 26 of the first body member 21 are a series of support prongs with rounded contact areas as illustrated at 27 and 28. The purpose of these prongs will be explained in more detail later. Also forming a part of the housing is a second hollow body member 30. This hollow body member has a hollow chamber 31 defined by a skirt 32 that includes a rear outer wall surface 33 and a slightly smaller forward outer wall surface 34. There is shown in FIG. 4 a shoulder surface 35 between wall surface 33 and 34. At a forward end of the second hollow body member is an annular hydraulic pressure surface 36 forming a sharp annular wiper ring edge 37 at a juncture with forward outer wall surface 34. The importance of the wiper ring edge and hydraulic pressure surface will be explained in more detail with reference to FIG. 9. In the exploded view of FIG. 4 are shown two hydrophobic depth filter discs 40 and 41. These two hydrophobic filter discs are firmly held in face-to-face relationship when the second hollow body member is telescopically urged into the chamber 22 of the first body member. In FIG. 5 the filter discs, with their circular shape, each have a thickness of 0.003 to 0.008 inch and a diameter of less than 0.375 inch. Preferably each disc has an effective area of 0.250 inch diameter. The discs are shown immediately before being pushed into the chamber 22 of the first hollow body member. In FIG. 6 the special filter device is shown in a vertical position after the second body member 30 has been permanently assembled to the first body member 21. It is seen here that the two hydrophobic filter discs 40 and 41 are supported in a central area by support prongs illustrated as 27 and 28. The filter discs are also firmly urged against an annular sealing ledge 42. In FIG. 7 the support prong 28 is substantially enlarged. In this view it is clearly shown that the supporting surface is a rounded generally hemispherical-shaped crown surface 43. This support prong is on the downstream side of the hydrophobic filter discs. At very low liquid flow rates through the filter disc the disc rides up on the crowned support surface 43 so as to rest on a very small area which transverse dimension is illustrated generally as a. The purpose of this minimal contact with the filter is to maintain as much area as possible of the filter available for filtering so that the filter can be very small in size. A single prong 28 contacts less than 5 percent of the filter area under normal administration pressures. When four prongs are used they contact the filter over less than 20 percent of its area. In previous filters that used a checkerboard grid surface, sometimes as much as 50 percent of the effective filtering area was blocked out by the supporting grid structure. I have been able to provide a very small filter of approximately 1/4 inch diameter in a highly efficient filtering device. Previous filter devices required filter discs as large as 1 to 2 inches in diameter. Such were extremely cumbersome for attaching to a venous needle. The dotted lines in FIG. 7 illustrate the interrelationship between the filter disc and support prong 28 when a pressure surge of liquid comes through the filter device. Such might happen when a hypodermic syringe injects a medicament into the administration line under very high pressures. When this happens the filter disc 41 will sink down on support prong 28 and is temporarily supported by a broader crowned surface whose lateral dimension is indicated by the b. After the pressure surge has gone the filter disc 41 will again ride up high on the support prong 28 so that minimal filtering area of the filter disc is blocked off. FIG. 8 shows the top view of the support prongs of FIG. 6. Here is shown four support prongs, each having a hemispherical protruding crown portion of 0.035 to 0.060 inch diameter. I have found that this construction works very well and blocks out less than 20 percent of the effective filtering area of a filter disc of approximately 1/4 inch in diameter. In the further enlarged fragmentary view of FIG. 9 a very important feature of the relationship of the filter housing and the filter discs is shown. In order for my special hydrophobic filter device to operate effectively as a final filter for parenteral solutions it is extremely important that the filter discs be permanently bonded about their peripheries to the filter housing. The importance of this cannot be overstressed because if there is any break in this peripheral seal to the housing, parenteral solution can flow around an edge of the filter disc and enter the venous needle in an unfiltered state. I have developed a very unique procedure for assembling the hollow body member 21 and second hollow body member 30 so that the disc is securely sealed to the housing. As shown in FIG. 9 the first hollow body member has a sharp annular edge 37 and an annular hydraulic pressure surface 36. This pressure surface preferably has a series of annular grooves such as 38 and 39 with land surfaces therebetween. The grooves help pick up the solvent when the part is dipped in solvent and the lands help drive the solvent into the filter disc's pores. The sharp corner at 37 and hydraulic pressure surface 36 combine with outer wall surface 34 to create a piston effect. After the second body member 30 has been dipped in a solvent such as cyclohexanone the second body member is telescopically urged into the first body member 21. As this happens the cyclohexanone rolls along the hydraulic pressure surface 36 to create an annular rolling ring of solvent. I have discovered that substantially rounded surfaces corresponding to surface 36 and edge 37 and pressure surface 36 do not create an effective rolling ring of solvent. With the structure shown in FIG. 9 the rolling ring of solvent contacts the two hydrophobic filter members 40 and 41, and the hydraulic annular pressure surface drives this rolling ring of solvent and the solvent in the grooves through the pores of peripheral segments of both the hydrophobic filter disc 40 and filter disc 41 and firmly presses the discs against annular ledge 42. As the two body members are pushed together the two filter discs become bonded, one to the first hollow body member 21 and one to the second hollow body member 30. The two body members are at the same time solvent bonded together. In this state the hydrophobic filter membranes take on a squeezed configuration at their peripheries such a shown at FIG. 6. I have found that this is an extremely reliable way to peripherally seal the two filters to the housing formed by the two hollow body members. Preferably, the hollow body members are of a transparent thermoplastic material. I have found that a rigid polypropionate works very well for the body members, but other materials could be used if desired. FIG. 10 is a still further enlarged fragmentary view showing just how the hydraulic force pushes the solvent into the pores of the filter member and permanently bonds it to the hollow body member. Such a sealing arrangement is very effective and does not rely on a particular degree of heating or welding. Once the filter device has been assembled the two filter discs 40 and 41 present a pair of "depth" filters in face-to-face relationship as shown in FIG. 11. A random path is shown by means of arrows to schematically illustrate a path liquid might travel through the hydrophobic filter discs. It is important to note that these two hydrophobic filter discs are of nonfibrous material so that no shedding of particles are likely to break off from the filter material. Once the filter device has been assembled as described above and fitted to a parenteral solution administration set as shown in FIG. 1, the intravenous administration is ready to start. Because the filter discs are hydrophobic and of a nonwetting nature, there is a special procedure for starting the filtering through the discs. The parenteral solution flows down to the hydrophobic filter discs that have randomly interconnected stacked passages of from 10 to 40 micron size and preferably from 20 to 30 micron size. When the liquid first contacts this hydrophobic filter it will pass only very slowly, if at all, through its pores. The hydrophobic filter is of polytetrafluoroethylene. Polytetrafluoroethylene filters have been used before specifically to prevent liquid passage but allow air passage. Examples of this type for use for a hydrophobic filter are shown in U.S. Pat. Nos. 3,631,654 and 3,157,431 that describe an air purge system and an air inletting spike respectively. These previous hydrophobic filters were used to stop liquid passage through the filter. I have discovered that with very large pore size of from 10 to 40 micron a hydrophobic filter will provide an amazing unit that will pass liquid. A shock wave, such as by a manual tap, sent through the filter device after the hydrophobic filter discs have "soaked" for 15 to 60 seconds, causes the liquid to freely flow through the hydrophobic filters that have interconnecting passages of from 10 to 40 micron. As liquid passes through these hydrophobic filters after the shock wave has initiated liquid flow provides an unexpected result. Even though the interconnecting passages are from 10 to 40 micron in size they filter out in excess of 95 percent of all particulate matter of 5 micron size and above if two discs as shown are used. In laboratory tests the filtering efficiency with the two discs of FIG. 6 averaged 97-98 percent removal of all particles of 5 micron size and above. Even with only one disc more than 90 percent of all particles of 5 micron size and above were removed. This filtering action occurs with a very small type filter. By discovering this amazing effect I have developed a highly efficient final filter for parenteral solutions that need be only approximately 1/4 inch in effective diameter or roughly the diameter size of the eraser on an end of a pencil. This is a tremendous advantage over previous final filters of the "wetting" or hydrophilic nature. These hydrophilic filters were often of from 1 to 2 inch diameter and their large housings were a burdensome weight on the venous needle sticking in the patient's arm. With my invention I have provided a unique filter for parenteral solutions that is very small in size and is also very efficient. I have provided this by using an unexpected functioning of a hydrophobic filter of relatively large pore size. Such a filter does pass liquid after an initial shock wave and does filter out very small particulate matter. Throughout the specification and the following claims I have used the word "hydrophobic" filter. By this term I mean to describe a filter of a generally nonwettable material, with polytetrafluoroethylene given as an example. The word "hydrophobic" has been used even though the filter does freely pass liquid after an initial shock wave has been sent through it. In the foregoing specification and claims I have used a specific example to describe my invention. However, it is understood by those skilled in the art that certain modifications can be made to this embodiment without departing from the spirit and scope of the invention.

1a

BACKGROUND OF THE INVENTION The present invention relates to bonding of materials, and more particularly to brazeless bonding of dissimilar materials. Even more particularly, the present invention relates to brazeless hermetically sealed bonding of ceramic to metal for use in implantable devices. stimulators that are to be implanted in living bodies and powered from external informational sources must be housed in packages of biocompatible material. Such packages must protect the electronic circuitry within the implanted stimulator from body fluids and ions so that the circuitry can survive for extended periods without any significant changes in performance. Today, the most commonly used metals for implantable packages are titanium, stainless steel and cobalt-chromium alloys. These metals are biocompatible and corrosion resistant. Normally, the package consists of two parts welded together to insure hermeticity. The electrical components inside the package are connected to stimulating leads by hermetic feedthroughs, which permit the flow of electrical currents through the package while maintaining hermeticity. However, where there is a need to inductively couple an alternating electromagnetic field to an internal pickup coil, the metal package becomes a hinderance. Specifically, transmission of power is substantially reduced by eddy currents generated in the metal package due to the alternating electromagnetic field. To solve that problem, receiving coils are often placed outside the metal package, increasing the size and complexity of the of the implanted device. It is known that the glasses and ceramics are transparent to alternating electromagnetic fields and that receiving antennas can be placed inside a hermetic zone of a ceramic or glass package, creating an overall smaller and simpler implant device and reducing the possibility of antenna failure due to saline leakage. Glasses and ceramics are inert and highly insoluble, which are favorable characteristics for long term implant materials. Unfortunately, however, because glasses and ceramics are inelastic, they are subject to fracture not only from mechanical shock but also from differential thermal expansion if even a moderate temperature gradient exists thereacross. Therefore, welding is not a practical method of sealing glass or ceramic materials. Instead, virtually the entire package and its contents must be raised to the melting temperature of the glass, ceramic or metal braze used to effect a sealing of the glass or ceramic package. Such sealing methods are unsatisfactory. All known biocompatible glasses and ceramics are characterized by high sealing temperatures that will damage electronic components commonly included in electronic devices implanted in living bodies. Low melting temperature glasses all have the property of being corroded by body fluids. Further, metal or glass frits and solders useful in brazing glasses and ceramics and having melting temperatures below the thermal damage limits of implanted electronic components are either not biocompatible or corrode easily in body solutions. Therefore, packages composed entirely of ceramic and/or glass are not considered practical for such implant applications. Also, in many ceramic and glass packages, the metal solder used to seal the main body and cap portions thereof forms a closed loop that is very close to coaxial with, or in a plane parallel to, the receiving coil used as the antenna for the electronics housed in the implantable package. Thus configured, the closed metal loop or solder acts as a shunt to the alternating electromagnetic fields impressed upon the package to transmit power and/or data to the implanted electronics. This has resulted in the generation of undesired heat within the package and the reduction of power transfer efficiency. A packaged combination of one ceramic and two metal members is shown in U.S. Pat. No. 4,991,582, issued to Byers et al. and incorporated herein by reference. The one ceramic member is a ceramic case and one of the metal members is a metal band. The other metal member is a header plate. The ceramic case and the metal band are hermetically sealed together, each being characterized by similar coefficients of linear thermal expansion. The final package closure is effected by soldering the metal band to the ceramic case and the metal header plate to the metal band. The junction between the ceramic case and metal band includes a bond of flat and smooth non-interlocking geometries. By such a design, forces resulting from unequal expansion or contraction of materials in or near the junction of the ceramic and metal members during temperature changes within and about the package are very inefficiently transferred to the ceramic members. This reduces the risk of residual strain and ultimately of fractures in the ceramic. Alternatively, where the coefficients of linear thermal expansion of the ceramic case and metal band are similar, i.e., very close, the junction between the ceramic case and metal band may be interlocking to effect a self-jigging of the members during assembly. In such a form, temperature changes will produce corresponding changes in the geometries of the ceramic and metal members and undesired stresses on the junction will be minimized. More particularly, the ceramic case shown in the '582 patent consists of a hollow flattened ceramic sleeve having a closed end and side walls and an open end for receiving electronic components of an implantable device, which are adversely sensitive to high temperatures such as those components that receive and transmit electromagnetic energy from or to the outside of the package. The coils comprising the antenna are positioned within the ceramic sleeve remote from and in a plane transverse and preferably normal to a flat annular end surface around the open end of the ceramic sleeve where the metal band is bonded. The metal band has a flat annular edge hermetically sealed as by a biocompatible metallic braze or glass solder to the flat annular end surface of the ceramic sleeve. Thus configured, the closed metal loop formed by the metal band and/or metal solder does not act as a shunt to power and/or information conveying alternating electromagnetic fields impressed upon the package and antenna of the present invention. Finally, the header plate closes the package by means of an hermetic bond to the metal band. The header plate carries a plurality of electrical feedthrough connectors for connecting electrical leads to the electronic components within the package. The metal sleeve is bonded by high temperature welding, such as electron beam or laser welding, to the metal band after the electrical components are mounted in the ceramic sleeve (or case) and adequate heat sinking is applied to insure that there is no heat transfer to any heat sensitive electronic components or ceramic package component during the hermetic sealing operation. Unfortunately, the package shown in the '582 patent still requires the use of a hermetically sealed weld or solder joint between the ceramic case and the metal band that suffers from one or more the following problems: (a) lack of biocompatability; (b) lack of corrosion resistance; (c) lack of electrolytic compatibility; (d) susceptibility to cracking of the ceramic case; and/or (e) toxicity. Thus, improvements are needed to overcome these problems with hermetically sealed bonds of ceramic to metal in packages for implantable devices. SUMMARY OF THE INVENTION The present invention advantageously addresses the needs above as well as other needs by providing an apparatus and method for forming a brazeless hermetically sealed bond. The invention may be characterized as a method of forming the hermetically sealed bond between materials. The method includes positioning a first structure, made from a first material, against a second structure, made from a second material. A compressive force directed at the second structure is applied to the first structure, and an equal force directed at the first structure in a direction opposite the compressive force is applied to the second structure so that the first and second structures are isodynamically pressed together. Next, the first and second structures are heated to a diffusion temperature whereat the first material and the second material undergo diffusion, thereby forming a hermetically sealed bond between the first and second materials. In this way, the hermetically sealed bond is formed between the first and second structures. In one embodiment, the first structure is inserted or slid into a cavity of an inner jig through an open end of the cavity until the first structure seats against a closed end of the cavity. Next, the second structure is placed against a portion of the first structure that is exposed through the open end of the cavity. The second structure may be partially inserted into the cavity through the open end before it seats against the first structure, or the second structure may seat against the first structure at or outside the open end. An outer jig is placed against a support surface, and then the inner jig is inserted into an open-ended cavity of the outer jig. Outer walls of the inner jig slide against inner walls of the outer jig's open-ended cavity so as to restrict the sliding of the inner jig to be along a single coordinate axis. The support surface lies in a plane substantially normal to the single coordinate axis, with the open end of the inner jig's cavity being oriented toward the plane and the closed end of the inner jig's cavity being oriented away from the plane. The second structure is also oriented toward the plane. As the inner jig is slid into the outer jig, the second structure seats against the support surface. As a result, the sliding of the inner jig into the outer jig is stopped. The compressive force is applied against the inner jig toward the support surface and along the single coordinate axis. The compressive force is translated to the first structure by the closed end of the inner jig's cavity. The equal force is exerted by the support surface in the direction opposite the compressive force, and is translated to the second structure by the support structure. In this way, a hermetically sealed bond is created between the first structure and the second structure. The invention may also be characterized as an apparatus for forming a hermetically sealed bond between materials. The apparatus includes: an inner jig; an outer jig; a support surface; compressing means; and heating means. The inner jig has outer walls, and a cavity. The cavity has an open end formed so as to receive a first structure, and has a closed end against which the first structure can be seated. The outer jig has an open-ended cavity having inner walls that slidably engage the outer walls of the inner jig. When the outer walls of the inner jig are slidably engaged against the inner walls of the outer jig, movement of the inner jig is restricted to be along a single coordinate axis. The support surface has a substantially planar surface against which the outer jig is supported, and that is substantially normal to the single coordinate axis. Before the inner jig is slid into the outer jig, a second structure is interposed between the first structure and the support surface. The second structure may be inserted into the open end of the inner jig's cavity, and seat against the first structure therein, or may seat against the first structure at or outside the open end of the inner jig's cavity. Such will depend on whether the first structure protrudes through the open end of the inner jig's cavity when the first structure seats against the closed end of the inner jig's cavity. The compression means applies a compressive force applied against the inner jig, which is translated to the first structure by the inner jig. The compressive force is oriented toward the planar surface along the single coordinate axis. The compression means further applies an equal force opposite the compressive force to the support surface. The support surface translates the equal force to the second structure so as to isodynamically compress a bonding junction between the first and second structures. The heating means heats the first and second structures to a diffusion temperature. At the diffusion temperature, a first material in the first structure and a second material in the second structure undergo diffusion. As a result, a hermetically sealed bond is formed between the first and second structures. It is therefore a feature of the invention to provide a method and apparatus for forming a hermetically-sealed bond between a first structure and a second structure. It is another feature of the invention to form such hermetically-sealed bond without the need for soldering. It is a further feature of the invention to form such hermetically-sealed bond while maintaining biocompatability, corrosion resistance and electrolytic compatibility, and eliminating toxicity. It is an additional feature of the invention to form such bond while minimizing the risk of cracking in the first and/or second structures. BRIEF DESCRIPTION OF THE DRAWINGS The above and other aspects, features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein: FIG. 1 is a cross-sectional view of a case and a band having been bonded together in accordance with one embodiment of the invention taken along a first sectional plane; FIG. 2 is another cross-sectional view of the case and the band having been bonded together as in FIG. 1 taken along a second sectional plane that intersects line A--A of FIG. 1 and that is normal to the first sectional plane, which intersects line B--B in FIG. 2; FIG. 3 is an end view of the band of FIGS. 1 and 2 showing a flat annular surface to which a similar flat annular surface of the case is bonded; FIG. 4 is a perspective view of an outer jig that can be used in bonding together the case and band of FIGS. 1, 2 and 3; FIG. 5 is a perspective view of an inner jig that can be used in conjunction with the outer jig of FIG. 4 when bonding together the case and band of FIGS. 1, 2 and 3; FIG. 6 is a cross-sectional view of the inner jig of FIG. 5 taken along plane C of FIG. 5; FIG. 7 is a side view of the inner jig of FIG. 5 shown perpendicular to plane C of FIG. 5; FIG. 8 is a perspective view of a support surface that is utilized in conjunction with the outer jig of FIG. 4 and the inner jig of FIGS. 5, 6 and 7 in bonding together the case and band of FIGS. 1, 2 and 3; and FIG. 9 is a partial cross sectional view of the outer jig of FIG. 4, taken along plane D of FIG. 4, and the inner jig of FIGS. 5, 6 and 7. DETAILED DESCRIPTION OF THE INVENTION The following description of the presently contemplated best mode of practicing the invention is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. Referring first to FIG. 1, a cross-sectional view is shown of a case 10 and a band 12 (or case/band assembly 8) having been bonded together at a bonding site 14. Similarly, in reference to FIG. 2, a cross-sectional view is shown of the case 10 (or first structure) and the band 12 (or second structure) having been bonded together at the bonding site 14. The view shown in FIG. 1 is taken along line B--B shown in FIG. 2, and the view shown in FIG. 2 is taken along line A--A shown in FIG. 1. In both FIGS. 1 and 2, the case 10 is shown as having a "D" shaped cross section. Such cross section facilitates implantation and accommodates any electronic components that are to be housed within the case/band assembly 8, as well as one or more coils that can be housed within the case/band assembly 8. The case 10 is preferably made from a body-safe ceramic, e.g., Alumina (AlO 2 ) or Zirconium Oxide (ZO 2 ), and is open at its straight end, i.e., the straight end of the "D" shape while its curved end and side walls are closed. Walls 16 of the case 10 terminate around the open end forming a first annular surface 18. Referring next to FIG. 3, an end view is shown of the band 12 showing a second flat annular surface 20 (also shown in FIGS. 1 and 2) to which the first flat annular surface 18 of the case 10 is ultimately bonded. The band 12 is preferably made from a body-safe metal, e.g., an alloy of Titanium-45 Niobium (i.e., 55% Ti and 45% Nb), available from Teledyne Wha Chang of Albany, N.Y., or numerous other sources, or any other metal or alloy that readily forms an instant oxide when heated, i.e., that readily oxidizes when heated in an oxygen-containing atmosphere. Note that both the alumina and the Titanium-45 Niobium have thermal coefficients of expansion (TCEs) of between 8 and 9 mm 3 /°C. This minimizes the risk of cracking when the case 10 and band 12 are bonded together at high temperature and then cooled. The band 12 has two open ends. Side walls 22 of the band case 12 terminate at each of the open ends, forming the second flat annular surface 20 at one of the ends, and having, e.g., a flanged edge 24 at another of the ends, which can be for receiving a header plate (not shown). See, e.g., U.S. Pat. No. 4,991,582, previously incorporated herein by reference. Referring next to FIG. 4, a perspective view is shown of an outer jig 30 that is used in bonding the case 10 and band 12 together. The outer jig 30 has generally a rectangular three dimensional shape with a rectangular cavity 32 passing therethrough. The upper surface 34 is identical to the lower surface 36 except for a channel 38 in the lower surface 36 that passes from the center of one of the outer side edges of the outer jig 30 to the center of one of the inner side edges of the cavity 32. The channel 38 is also illustrated in FIG. 9 and is explained more fully below. The dimensions of the outer jig 30 are dictated by the size and shape of the case 10 and band 12 that are bonded together. For the case 10 and band 12, shown in the figures, the outer jig 30 is preferably made from ALUMINA, available from ICI Advanced Ceramics, and has the following outer dimensions: 8.97×7.06×3.81 cm. The dimensions of the cavity 32 are preferably: 3.89×1.98×3.81 cm, and the channel preferably has a cross sectional area of 7.70 cm 2 . The outer jig 30 preferably has beveled or rounded edges to improve its appearance and to facilitate its handling. Referring next to FIG. 5, a perspective view is shown of an inner jig 40 that is used in conjunction with the outer jig 30 in bonding together the case 10 and band 12. Like the outer jig 30, the inner jig 40 has generally a rectangular three dimensional shape. The inner jig 40 has a cavity 42 opening on one of its sides that is formed so as to receive the case 10. When the case 10 is inserted into the cavity 42 it to is held with all of the interior walls of the cavity 42 touching all of the exterior walls of the case 10. For the preferred embodiment shown in the figures, the inner jig 40 is preferably made from ALUMINA, available from ICI Advanced Ceramics, and has the following outer dimensions: 3.81×1.90×3.81 cm so that the inner jig 40 can be slid into the cavity 32 of the outer jig 30. The inner jig 40 preferably has beveled or rounded edges to improve its appearance and handling. In practice, the case 10 is slid into the inner jig's cavity 42 until it becomes seated against a closed end 44 (FIG. 6) and side walls 46 (FIG. 6) of the cavity 2. After the case 10 is slid into the cavity 42, the band 12 is slid into the cavity 42 until the second flat annular surface 20 (FIGS. 1 and 2) seats against the first flat annular surface 18 (FIGS. 1 and 2) of the case 10. The band 12 protrudes from the cavity 42 when it is seated against the case 10, as shown in FIG. 9 below. Referring to FIG. 6, a cross sectional view of the inner jig is shown taken along plane C of FIG. 5. As viewed in FIG. 6, the cavity 42 in the inner jig 40 is substantially "D" shaped so as to accommodate the "D"-shaped case/band assembly 8 of FIG. 1 (or case 10 and band 12, before they are bonded together). Referring next to FIG. 7, a side view is shown perpendicular to plane C of FIG. 5 of the inner jig. The inner jig 40 is shown, and the cavity 42 is shown with dashed lines. The cavity 42 also has a "D" shaped cross section as viewed in FIG. 7, which accommodates the "D"-shaped cross section of the case/band assembly 8 as viewed in FIG. 2 (or case 10 and band 12, before they are bonded together). Referring next to FIG. 8, a perspective view is shown of a support surface 50 that is utilized in conjunction with the outer jig 30 and the inner jig 40 in bonding the case 10 and band 12. The support surface 50 has a lip 52 at the periphery of an upper side 51 of the support surface 50. The lip 52 is used to keep powdered titanium oxide on the support surface 50. (Use of the powdered titanium oxide powder is described below.) A lower side 53 of the support surface is supported against, e.g., an alumina plate, which in turn rests against a rack or grill within a vacuum oven, described below. The support surface 50 has a vent hole 54 near its center that allows gasses to readily enter and exit the case/band assembly 8 when the other open end of the band 12, i.e., not the end that is against the open end of the case 10, is aligned over the vent hole 54. Referring to FIG. 9, a partial cross sectional view is shown of the outer jig 30, the inner jig 40, the support surface 50, and the case/bend assembly 8. The lower surface 36 of the outer jig 30 is held by gravity against the upper side 51 of the support surface 50 with the upper jig's channel 38 having a central longitudinal axis within the plane of the paper in FIG. 9, and shown to the left of the cavity 32 of the outer jig 30. The case 10 is inserted into the inner jig's cavity 42 until it seats against the closed end 44 and sides 46 of the inner jig 40. Next, the band 12 is inserted into the cavity 42 until it seats against the case 10 and the sides 46 of the cavity 40. The band 12 protrudes from the cavity when seated against the case 10 and sides 46. Before inserting the case 10 and band 12 into the cavity 42, however, the interior surface of the cavity 42, as well as the upper side 51 of the support surface 50, is coated with powdered titanium oxide (TO 2 ) to prevent the case 10 and band 12 from bonding to the inner jig 40 and support surface 50. The inner jig 40, with the band 12 protruding therefrom, is inserted cavity-first into the outer jig 30 through the open end of the outer jig's cavity 32 at the upper surface 34 of the outer jig 30. The inner jig 40 is inserted into the outer jig's cavity 32 until the band 12 protruding from the inner jig 30 seats against the support surface. The inner jig 30 does not come into contact with the support surface 50. While the inner jig 30 is sliding into the outer jig's cavity 32, the inner jig's movement is restricted to movement along a single coordinate axis, which is preferably normal to the support surface 34, i.e., the plane defining the upper side 51 of the support surface 50. The other open end of the band, i.e., the open end of the band 12 that is not seated against the case 10, is centered over the vent hole 54, and a chamber formed by the space within the outer jig's cavity 32, below the inner jig 40, above the support surface 50 and outside the band 12, is vented by the channel 38 in the outer jig 30. The support surface 50, outer jig 30, inner jig 40, case 10 and band 12 are placed onto, e.g., a grate (not shown) in a vacuum oven 70, and a compressive force F is applied along the single coordinate axis to the inner jig 40 in a downward direction, as depicted in FIG. 9 by the downward pointing arrow. This force may be applied by placing weights subject to gravity on top of the inner jig 40. The weights can be secured by wrapping stainless steel bands over the top of the weights and securing them under the support surface 50. Preferably, four or more bands having a width of 1.27 cm and a thickness of 0.025 cm are used. The compressive force applied should be from between 950 N/m 2 to 1500 N/m 2 . The compressive force F is translated to the case 10 by the inner jig 40. Note also that an equal force is applied by the support surface 50, to the band 12 along the single coordinate axis opposite the direction of the compressive force F. The compressive force F and the opposing equal force isodynamically press the case 10 and band 12 together at the sight where the second flat annular surface 20 of the band 12 is seated against the first flat annular surface 18 of the case 10. Next, a sealed chamber of the vacuum oven 70 is evacuated to at least 10 -5 , preferably 10 -6 , atmospheres using a vacuum pump 72. The vacuum oven 70 is then heated by energizing a heating coil 74 using a power supply 76. The temperature in the vacuum oven is heated at the rate of approximately 5° C./minute until it reaches a temperature of at least 1000° C., preferably to between 1000° C. and 1100° C. This temperature is maintained for about 2 hours, i.e., 120 minutes, by a thermostat 78 that is coupled to the power supply 76. The thermostat 78 uses a temperature probe 80 to monitor the temperature within the vacuum oven 70. After the 2 hours, the vacuum oven 70 is cooled at a rate of approximately 1° C./minute, which generally takes about 17 hours, e.g., 1000 minutes, at ambient temperature. Preferably, no forced cooling is performed, i.e., no cold gas spray, or other exposure to a cold environment. Note that during the cooling of the vacuum oven 70, the heating coil 74 will generally remain energized, at least partially, in order to assure that the desired slow rate of cooling is achieved, i.e., 1° C./minute. During the time the case 10 and band 12 are heated and pressed together, titanium atoms from the band diffuse into the alumina of the case 10. This is caused by an attraction of the titanium atoms to oxygen atoms that are loosely held by the alumina at the above-mentioned temperatures. When the case 10 and band 12 are cooled, the titanium atoms share the oxygen atoms with the alumina. In this way, a hermetically sealed bond is formed between the case 10 and band 12, so that the case 10 and band 12 can be safely utilized to house an implantable electronic device. Advantageously, the bonding does not degrade or crack the metal or ceramic, and they each maintain their hermeticity. A header plate (not shown) is used to seal the other end of the band after electronic circuits, and, e.g., inductive pickup coils, are inserted into the case/band assembly 8. The header plate is bonded to the band by, e.g., welding, as is described in U.S. Pat. No. 4,991,582, previously incorporated herein by reference. Note that because the electronic circuits are not inserted into the case/band assembly 8 until after the cooling, and because the header plate can be sealed to the other open end of the band 12 without the need for heating the entire case/band assembly 8 to high temperatures, the electronics are much less prone to heat damage than with many heretofore utilized techniques for bonding the ceramic case 10 to the metal band 12. While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.

1a

This is a divisional of copending application Ser. No. 07/125,652 filed on Nov. 30, 1987, now U.S. Pat. No. 4,919,129. RELATED CASE The subject matter of this application is related to the subject matter of U.S. Pat. No. 4,307,720 which is incorporated herein by reference. BACKGROUND OF THE INVENTION Field of Invention This invention relates to electrocautery surgical instruments and more particularly to an electrocautery scalpel system having variably extendable suction and electrode elements to facilitate electrocautery surgery at deep locations within surrounding tissue. Electrocautery instruments commonly rely upon high-voltage, high-frequency electrical signals of various waveforms to selectively sever, clamp or coagulate living tissue during surgical procedures. In addition, many such electrocautery instruments include integral vacuum conduits and associated suction apparatus for evacuating tissue fluids and volatized tissue materials that commonly accompany electrocautery incision of living tissue. Devices of these types are disclosed in the literature (see, for example, U.S. Pat. Nos. 1,311,494; 1,963,636; 2,002,594; 2,894,512; 3,662,151; 3,682,162; 3,828,780; 3,835,842; 3,850,175; 3,884,237; 3,902,494; 3,906,955; 3,974,833; 3,987,795; 4,011,872; 4,112,950; and 4,562,838; and French Patent No. 73.30854). Electrocautery instruments of these types also commonly employ a retractable electrode or a vacuum port to enhance the utility of the instrument during surgical procedures. One difficulty encountered with certain electrocautery scalpels having extendable and retractable electrodes is that the geometry of the instruments usually limits the depth in tissue to which the instruments can conveniently penetrate without expanding the incision to accommodate the surgeon's hand. As certain surgical procedures progress and penetrate deeper into a surgical site, it is frequently desirable to extend the instrument to longer dimension with control over the retractable electrode in order to facilitate advancing the surgery into deep, confined sites. SUMMARY OF THE INVENTION In accordance with the present invention, an improved electrocautery surgical instrument includes a retractable electrode and a vacuum conduit for selectively evacuating a surgical site, and also includes attachable extension units of various lengths for selectively extending the operational utility of the instrument as a surgical procedure progresses. The vacuum port and slidable electrode/blade of the instrument are thereby extended a selected dimension to facilitate deep surgical procedures in confined sites. Safety switching is included within the instrument to control application of high-voltage electrical signals to the electrode/blade and to permit the user to establish electrically inactive conditions during attachment and removal of extension units. The electrocautery surgical instrument thus configured according to the present invention facilitates surgical procedures in deep surgical sites as well as in shallow surgical sites without having to replace the instrument in the surgeon's hand during the surgical procedure. DESCRIPTION OF THE DRAWINGS FIG. 1 is a partial perspective view of the electrocautery surgical instrument with an attached extension unit; and FIG. 2 is a side view of the extension unit of FIG. 1; and FIG. 3 is a partial sectional assembly view of the extension unit of FIG. 1; and FIG. 4, 4(A) and 4(B) are an exploded assembly view of the instrument of FIG. 1; and FIG. 5 is a sectional view of the interlock switch of FIG. 4; and FIG. 6 is a sectional view of another embodiment of the interlock switch according to the present invention. FIG. 7(A) and (B) are plan and sectional views, respectively, of the body of the electrode scraping means; and FIGS. 8(A) and (B) are plan and side views, respectively, of a flat, blade-like electrode for assembly within the body of FIG. 7. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to FIG. 1, there is shown a perspective view of the electrocautery instrument 9 with an extension unit 11 attached to the front end of the instrument. Specifically, the retractable electrode/blade 13 is extended forward and is retractable within the extension unit 11, and the vacuum port 15 is also extended forward from the instrument 9 to provide substantially the same blade 13 and port 15 characteristic at the front of the extension unit 11 as are available on the front of the instrument 9 without the extension unit 11 in place. The extension units 11 may be of variable length as desired to facilitate deep surgical procedures, and may be attached and removed as desired by press-fit or snap-toggle attachment on the front of the instrument 9. A manually-slidable element 17 is attached to the electrode 13 to control the extent of the protrusion of the electrode 13 from the front of the attached extension unit 11. Push buttons 19 and 21 are provided to control application of different high-voltage, high-frequency waveforms to the electrode 13 for either incising or cauterizing tissue in known manner. In addition, the guide opening for the electrode 13 at the front of the extension unit 11 may be disposed closely about the blade 13 to scrape off adherent coagulum and tissue materials as the electrode is retracted therethrough in response to manual activation of the slide element 17. The Portion 27 of electrode 13 that is exposed is insulated to facilitate manipulation of the instrument within surrounding tissue without undesirably discharging electrical signals to surrounding tissue in the region 27 between the electrode 13 and the front 25 of the unit 9. A decompression port 29 is disposed in at least one lateral dimension from the vacuum port 15 to control the maximum pressure differential that can be developed at the vacuum port 15 under conditions of the port 15 being occluded by tissue which might be damaged by excessive suction. Referring now to FIG. 2, there is shown a side view of the extension unit 11. The lower tube 31 is the vacuum conduit with the vacuum port 15 and decompression port 29. The upper electrode 13 and connecting conductor 33 is insulated 35 over the region 27 that extends between the instrument 9 and the exposed electrode 13. The body 37 of the extension unit 11 may be welded, glued or otherwise attached to the vacuum tube 31, and serves as a guide for the electrode 13 which is slideably mounted therein. The electrode 13 may be needle-like, or generally flat (i.e., its width is greater than the thickness) to serve as a surgical blade. The body 37 may include a scraping guide 39 for removing adherent coagulum and tissue material as the electrode 13 and the conductor 33 to which it is attached is withdrawn into and through the body 37. The sectional view of FIG. 3 illustrates the attachment of the vacuum tube 31 to the body 37. Also, the electrode/blade 13 portion of the conductor 33 is shown disposed to slide within the guide way 41 in the body 37 through and past the scraping means 39 at the forward end thereof. Alternative embodiments of scraping means are described herein with reference to FIGS. 7 and 8. Referring now to the exploded assembly drawing of FIG. 4, there is shown the internal features of the instrument 9 which accommodate attachment of the extension unit 11 on the front end thereof. Specifically, the right and left half sections 43, 45 of the instrument 9 are disposed to house the switches, electrode, manual slider, vacuum conduit and valving, and associated wiring to form the electrocautery instrument when assembled as shown. The vacuum conduit or suction tube 47 in the lower portion of the sections 43,45 is positioned in fluid-tight engagement 49 with the vacuum port 51 in the forward end of the instrument 9, which vacuum port has an inner diameter (or other cross-sectional dimensions) that receive therein the attachment end of the vacuum conduit 31 of the extension unit 11 in press-fitted, fluid-tight engagement. Alternatively, jam taper fit, or threaded engagement, or snap-fitting o-ring on an annular recess may be used to seal and secure the instrument and extension unit together as well as form a continuation of the vacuum conduit 47, 31. Also, the vacuum port 51 of the instrument 9 may have a decompression port 53 for limiting the pressure differential at the port, as previously described with reference to the ports 15, 29 on the extension unit 11. This decompression port 53 is disposed within a socket or receptacle of the vacuum port 51 to be sealed off by insertion into such socket or receptacle of the connecting end of the vacuum conduit 31 of the extension unit 11. The vacuum conduit is therefore extended forward to the vacuum and decompression ports 15, 29 of the extension unit 11 when the extension unit 11 is properly attached to the front of the instrument 9. This vacuum conduit may be connected via a suitable control valve such as a roller 55 disposed to manually Pinch off the flexible conduit 47 that connects to a remote vacuum supply (not shown). In this way, the operating surgeon may control the application of suction at a surgical site by positioning the vacuum port 15 (or 51, if an extension unit 11 is not attached) and by manually rotating the pinch roller 55 to selectively pinch off the flexible conduit 47, and thereby control the vacuum action at the port 15. In the upper portion of the instrument 9, the slide element 17 is disPosed to slide longitudinally in tracks or grooves 61 in the body of the instrument 9. The tab 68 that protrudes from the slide element 17 through a groove 65 engages the slide electrode 100 at the recess 101 to thereby control retraction and extension of the electrode 71 under manual control of the slide element 17. The electrode conductor 69, in one embodiment of the present invention, may slide in electrical contact through contactor 67 to engage the safety switch 85 in its rearward-most retracted position. The electrode 71 attaches 73 to the slide electrode 100 at the forward end thereof for gripping the electrode/blade 71 (or the contact end 33 of the electrode conductor 35 of an extension unit 11) by friction or snap-toggle engagement, or the like, in known manner. The switch plate 63 includes conventional dome-type switches 79, 81 which may be activated by the push buttons 75, 77 that are mounted in the body of the instrument 9. Thus, the push-button switches 79, 81 may be manually activated when the slide element 17 (and therefore the electrode/blade 71 or 13) is positioned in the forward location. In the rearward position of the slide element 17, one or more of the push-button switches 79, 81 are shrouded by the slide element 17 as protection against inadvertent manual activation. Additionally, the rearward end of the electrode conductor 69, 71, is disposed to engage an interlock switch 85 that is wired into the circuit including the electrode and a source (not shown) of high-frequency, high-voltage electrical signals. Thus, electrical signals for either severing or cauterizing tissue are connected from such source via a cable 87 (which may be integral with the vacuum conduit for convenience) to the switches 79, 81 on the switch plate 63. The interlock switch 85 is thus disposed to cut off the application of all electrical signals when the electrode conductor 69 is in the rearward-most position. In this position, the slide element 17 shrouds either or both of the Push buttons 75, 77 as a further safety interlock feature while the electrode is withdrawn rearwardly into the body of the instrument 9 (or into the body 37 of an extension unit 11). Scraping means 89, as illustrated in FIG. 7, may be disposed about the electrode/blade 71 to dislodge adherent coagulum and tissue material as the electrode/blade 71 is withdrawn into the body under manual control of the slide element 17. Thus, during operating procedures, the electrode/blade 71 (or 13 of an extension unit 11) may be withdrawn into the body of the instrument 9 (or of the extension unit 11) under manual control of the slide element 17 to clean the blade and to configure the front end of the unit to facilitate its use simply as a vacuum probe to evacuate a surgical site. In this configuration, the push buttons 75, 77 are shrouded against inadvertent activation, and the roller 55 may be manually activated to pinch and unpinch the flexible tubing 47, as desired. Alternatively, the electrode 71 (or 13 of an extension unit 11) may be advanced under manual control of the slide element 17 to protrude from the instrument 9 (or extension unit 11). In this configuration, the push buttons 75, 77 are exposed and may be manually activated to control the supply of either severing or coagulating electrical signals to the electrode/blade via the interlock switch 85. Referring now to FIG. 5, there is shown a sectional view of one embodiment of the interlock switch 85 which is disposed within an enclosing housing 91 to be actuated by the rearward end of the electrode conductor 69. Thus, the control leads 93, 95 (which may conduct low-voltage control signals) from the push button switches 79, 81 on the contact plate 63 connect via the cable 87 to a conventional source (not shown) of high-voltage, high-frequency signal, and such signal is thus supplied through a power conductor 86 in the cable 87 and through contact 84 of the interlock switch 85 to the switch plate 63, slide contactor 67, and electrode 71 (or 13). In the rearward-most or retracted position of the electrode conductor 69, the power conductor 86 may be shunted to ground through alternate contact 88 and a ground conductor 90 in the cable 87. In another embodiment of the interlock switch 85 according to the present invention, as illustrated in the sectional view of FIG. 6, the electrode conductor 69 of FIG. 4 is formed in a printed-circuit like structure 103 including a non conductive central region 105 having a recess 107 to receive the tab 68 of the slide element 17, and a rearward section 109 that includes a conductor 110 disposed on an insulating layer 112. The conductor 110, of course, connects to the attaching means (or universal chuck) 73, and is slideably engaged by contacts 114 and 119. Electrical signal on contacts 114 (from a signal generator not shown) is applied to the electrode 71 (or 13 of an extender unit) while such electrode is in extended position under the manual control of the slide element 17. However, the insulating layer 112 of the electrode conductor 69 includes an aperture 116 at a location approximately at the maximum rearward extent of travel (i.e. retracted electrode) and in line with the contact 114. Another sliding contact 118 is disposed to connect to the contact 114 only within the aperture 116, and to be insulated therefrom by the insulating layer 112 otherwise. In the retracted position of structure 103, the sliding contact 119 may also be insultated by 112 from conductor 110 based upon the particular pattern of the conductor 110. Contact 118 may be connected back to ground via the shield on cable 87. Therefore, the electrode 13 or 71 may be effectively grounded while in the retracted position to prevent inadvertent electrical excitation of the electrode blade 71 (or 13) during configuration and use of the instrument as a vacuum probe, or during attachment of detachment of an extension unit. Referring now to FIG. 7A and B, there are shown plan and sectional views, respectively, of the scraping means 89 for guiding and scraping the electrode blade illustrated in FIGS. 8A and B. Specifically, these views illustrate the ferrule-like structure 89 of FIG. 7 that may conveniently snap into place near the forward edge of the instrument (or of an extension unit) for easy replacement of electrodes of different configurations (e.g. flat or needle-like). Thus, the scraping means 89 includes a generally hollow body through which the electrode 13 of FIG. 8 slides, and includes a close-fitting forward aperture 121 which engages the blade portion 123 of the electrode 13 is sliding, contacting relationship. The rear portion of the body 89 includes resilient jaws-like structure 125 to facilitate assembly of the electrode 71 (including the section 127 of expanded diameter) into the body from the rearward end toward the forward end. The jaws-like structure return to position to retain the electrode 71 entirely to captivated and slideable within the body 89. The section 127 is received by and retained in the attachment means 73 to facilitate the mechanical sliding motion of the electrode 71 within the body 89 under manual control of the user. Spring-like protrusions 129 formed on the body 89 about its central section facilitate the snap-in retention of the body 89 and captivated electrode 71 within and near the forward end of the instrument 9. Thus, electrodes 71 of different shapes and lengths may be conveniently inserted in and removed from the instrument (or extension units) as the surgical operation proceeds. In operation, the instrument 9 (with or without attached extension unit 11) may be configured to operate either as a vacuum probe alone (with the electrode/blade 71, 13 retracted) or as an electrosurgical instrument with the electrode/blade 13, 71 extended into operational position. In the latter configuration, the electrical control buttons are exposed and the safety, interlocking switch is actuated to permit high-voltage, high-frequency electrical signals to be supplied to the protruding electrode/blade under control of one or more of the uncovered, exposed push buttons. The operational length of the instrument may be altered by attaching or detaching extension units of desired length. The vacuum port of the instrument is altered by attachment of an extension unit, and the electrode/blade of the extension unit is electrically connected and mechanically attached for convenient manual extension and retraction control from the instrument. Therefore, the method and apparatus of the present invention facilitates the convenient extension of an electrocautery surgical instrument to accommodate surgical procedures performed deep within surrounding tissue while providing interlock features that enhance the safety and utility of the instrument during attachment and detachment of extension units and during its operation as a vacuum probe.

1a

BACKGROUND OF THE INVENTION The invention relates to a source of pulses for electronic instruments designed for suppression of pain. There are known instruments, which provide oscillations of a frequency from 10 Hz up to 2000 Hz, with a voltage around 30 V, the principle of which resides in the fact that after output electrodes have been applied on the skin of a patient--at least one of the electrodes being situated in the respective active spot--there appears to be an analgetic effect, i.e. phantom pains are either diminished or suppressed completely. As to the design of these known instruments, a source of oscillation is mostly represented by a multivibrator having excitation voltages of 30 V and more, or with other additional circuits, transformers, etc. This fact makes the requirements for a supply source and dimensions of the instrument more complicated. SUMMARY OF THE INVENTION The abovementioned drawback may be obviated by wiring a multivibrator with a double amplitude of the output signal according to the invention, the principle of which resides in the fact that in parallel to the input terminals, there are connected both a serial combination of a first charging diode, first and second charging capacitors and a second charging diode, as well as the emitters of a first complementary pair of transistors, the collectors thereof being connected to a common point B of the first and second charging capacitors, while the bases thereof are connected through exciting resistors to a common point A of the collectors of a second complementary pair of transistors, the emitters of which being connected through respective diode gates and the charging diodes, shunted by a first and second smoothing condenser, to the input terminals, the bases of the second complementary pair of transistors being interconnected by means of a charging resistor and connected through respective coupling condensers to the common point B of the collectors of the first complementary pair of transistors and charging capacitors. The wiring according to the invention is in fact a multivibrator with two pairs of complementary transistors, one pair of which also works as a change-over switch and feeder of the voltage doublers, working in the rhythm of the multivibrator. If we do not take into consideration voltage drops in the semiconductor junctions, then the amplitude in the output of the multivibrator at a common points A and B is four times greater than the supply voltage of the source. DESCRIPTION OF THE DRAWING In order that the invention may be clearly understood and readily carried into effect, a preferred embodiment thereof is, by way of example, hereinafter more fully described and illustrated in the accompanying drawing, in which: FIG. 1 shows a wiring diagram of the multivibrator according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the FIGURE, in parallel to input terminals 1 and 2, there are connected a serial combination of a first charging diode 3, a first charging capacitor 4, a second charging capacitor 5, a second charging diode 6, and a first complementary pair of transistors 10 and 11, the emitters of which being connected to the input terminals 1, 2, respectively, and the collectors of which being connected to a common point B of the first and second charging capacitors 4 and 5. The bases of the first complementary pair of transistors 10, 11 are connected, through respective feeding resistors 13, 14, to a common point A, to which the collectors of a second complementary pair of transistors 15 and 16 are respectively connected. The emitters of the second complementary pair of transistors 15, 16 are respectively connected, through diode gates 7 and 8 and the charging diodes 3, 6, shunted by first and second smoothing condensers 9 and 12, to the input terminals 1, 2. The bases of the second complementary pair of transistors 15, 16 are mutually connected by means of a shunting charging resistor 17, and by means of respective coupling condensers 18 and 19, which in turn are connected to the common point B of the first and second charging capacitors 4, 5 and the collectors of the first complementary pair of transistors 10, 11. After connecting the source of supply voltage to terminals 1 and 2, one of the transistors 15 or 16 starts opening more quickly than the other. Let us assume that it is transistor 15. So, in the common point A of the collectors of transistors 15 and 16, a positive voltage of the source appears. Voltage drops in the semiconductor junctions may be neglected for making the case simpler. The positive voltage in the common point A causes the closing of the transistor 10 and the opening of the transistor 11. In this way the common point B of the collectors of transistors 10 and 11 and the charging capacitors 4 and 5 is connected to the zero potential terminal 2 of the supply voltage, and the capacitor 4 is charged to the full voltage of the source through the charging diode 3. As the coupling condensers 18 and 19 are also connected to the common point B, which is now connected to the zero potential terminal 2, the coupling condenser 18 will be charged by the base-emitter path of the transistor 15, and, through the charging resistor 17, the coupling condenser 19 will be charged as well. The positive voltage across the bases of the transistors 15 and 16 causes a change of their conductivity. The transistor 15 closes while the transistor 16 opens and, in this way, connects the common point A of the collectors of the transistors 15 and 16 to the zero potential terminal 2 of the supply voltage source. This fact causes the opening of the transistor 10 and the closing of the transistor 11. The common point B of the collectors of the transistors 10 and 11 and of the charging capacitors 4 and 5 has now the same potential as the positive terminal 1 of the source. As the charging capacitor 4 was charged in advance, the voltage between the positive end of capacitor 4 and the zero potential terminal 2 is doubled with respect to the voltage of the source. The smoothing condenser 9 is fed with this voltage through the diode gate 7. Simultaneously, the capacitor 5 is charged through the charging diode 6 and the coupling condenser 19 is discharged through the base-emitter path of the transistor 16; through the resistor 17, there is discharged the coupling condenser 18. The discharging of the coupling condensers 18 and 19 causes again a change of conductivity of the transistors. The transistors 15 and 11 open, the transistors 16 and 10 close. At the common point A, the potential is identical with the potential of the positive end of the smoothing condenser 9, viz. it is higher than the voltage of the supply source. The common point B is connected again to the zero potential terminal 2. The charging capacitor 4 is charged again through the diode 3 to the voltage of the source. The charging capacitor 5 is discharged through the diode gate 8 into the smoothing condenser 12. Simultaneously, the coupling condenser 18 is charged through the base-emitter path of transistor 15 and the coupling condenser 19 through the charging resistor 17. The charging of these condensers causes again the change of conductivity of the transistors 15 and 16 and the process repeats in the described way. The smoothing condensers 9 and 12 are charged continuously up to the full voltage of the source. At the positive end of the smoothing condenser 9, the voltage is doubled with respect to the zero potential terminal, and at the negative end of the smoothing condenser 12, there is the same voltage, but of the opposite polarity than the voltage of the supply source. Across the mentioned ends, the voltage is tripled with respect to the supply source. Between the common points A and B, rectangular voltage pulses arise. If one marks the supply voltage U and if one neglects the voltage drops in the semiconductor junctions, then in case of conductivity of transistors 15 and 11, at the common point A, a voltage of +2U takes place, and at the common point B there is zero voltage. In case of conductivity of the transistors 16 and 10, a voltage -U takes place at the common point A, and a voltage +U at the common point B. The change of these pulses is determined by the time constant of the coupling condensers 18 and 19 and the charging resistor 17. The wiring may be carried out even with an opposite polarity of semiconductor elements, condensers and supply voltage. The invention may be applied for portable battery instruments, where one needs voltage pulses, the amplitude of which is a multiple of the feeding voltage of ordinary batteries, e.g. portable embodiments of instruments for electric acupuncture. Although the invention is illustrated and described with reference to one preferred embodiment thereof, it is to be expressly understood that it is in no way limited to the disclosure of such a preferred embodiment, but it is capable of numerous modifications within the scope of the appended claims.

1a

FIELD OF THE INVENTION [0001] The present invention generally relates to an implantable medical device system, particularly a subcutaneous ICD (SubQ ICD) and an improved detection system and method for detecting arrhythmias from sinus tachycardia and noise in subcutaneous ECG signals. BACKGROUND OF THE INVENTION [0002] Many types of implantable medical devices (IMDs) have been clinically implanted over the last twenty years that deliver relatively high-energy cardioversion and/or defibrillation shocks to a patient's heart when a malignant tachyarrhythmia, e.g., atrial or ventricular fibrillation, is detected. Cardioversion shocks are typically delivered in synchrony with a detected R-wave when fibrillation detection criteria are met, whereas defibrillation shocks are typically delivered when fibrillation criteria are met and an R-wave cannot be discerned from the electrogram (EGM). [0003] The current state of the art of ICDs or implantable pacemaker/cardioverter/defibrillators (PCDs) includes a full featured set of extensive programmable parameters which includes multiple arrhythmia detection criteria, multiple therapy prescriptions (for example, stimulation for pacing in the atrial, ventricular and dual chamber; atrial and ventricular for bradycardia; bi-atrial and/or bi-ventricular for heart failure; and arrhythmia overdrive or entrainment stimulation; and high level stimulation for cardioversion and/or defibrillation), extensive diagnostic capabilities and high speed telemetry systems. These full-featured ICDs or PCDs, hereinafter IMD, are typically implanted into patients who have had, and survived, a significant cardiac event (such as sudden death). Additionally, these devices are expected to last up to 5-8 years and/or provide at least 200 life saving therapy episodes. [0004] Even though there have been great strides in size reduction over the past 20 years, the incorporation of all these features in an IMD, including the longevity requirements, dictates that the devices be typically much larger than current state of the art pacemakers. Such devices are often difficult to implant in some patients (particularly children and thin, elderly patients) and typically require the sacrifice of 1 or 2 veins to implant the lead system. Current technology for the implantation of an IMD uses a transvenous approach for cardiac electrodes and lead wires. The defibrillator canister/housing is generally implanted as an active can for defibrillation and electrodes positioned in the heart are used for pacing, sensing and detection of arrhythmias. [0005] Although IMDs and implant procedures are very expensive, most patients who are implanted have experienced and survived a sudden cardiac death episode because of interventional therapies delivered by the IMDs. Survivors of sudden cardiac death episodes are in the minority, and studies are ongoing to identify patients who are asymptomatic by conventional measures but are nevertheless at risk of a future sudden death episode. Current studies of patient populations, e.g., the MADIT II and SCDHeFT studies, are establishing that there are large numbers of patients in any given population that are susceptible to sudden cardiac death, that they can be identified with some degree of certainty and that they are candidates for a prophylactic implantation of a defibrillator (often called primary prevention). However, implanting currently available IMDs in all such patients would be prohibitively expensive. Further, even if the cost factor is eliminated there is shortage of trained personnel and implanting resources. [0006] One option proposed for this patient population is to implant a prophylactic subcutaneous implantable cardioverter/defibrillator (SubQ ICD) such that when these patients receive a shock and survived a cardiac episode, they will ultimately have an implant with a full-featured ICD and transvenous leads. [0007] While there are a few small populations in whom SubQ ICD might be the first choice of implantation for a defibrillator, the vast majority of patients are physically suited to be implanted with either an ICD or SubQ ICD. It is likely that pricing of the SubQ ICD will be at a lower price point than an ICD. Further, as SubQ ICD technology evolves, it may develop a clear and distinct advantage over ICDs. For example, the SubO ICD does not require leads to be placed in the bloodstream. Accordingly, complications arising from leads placed in the cardiovasculature environment is eliminated. Further, endocardial lead placement is not possible with patients who have a mechanical heart valve implant and is not generally recommended for pediatric cardiac patients. For these and other reasons, a SubQ ICD may be preferred over an ICD. [0008] There are technical challenges associated with the implantation of a SubQ ICD. For example, SubQ ICD sensing is challenged by the presence of muscle artifact, respiration and other physiological signal sources. This is particularly because the SubQ ICD is limited to far-field sensing since there are no intracardial or epicardial electrodes in a subcutaneous system. Further, sensing of atrial activation from subcutaneous electrodes is limited since the atria represent a small muscle mass and the atrial signals are not sufficiently detectable transthoracically. Thus, SubO ICD sensing presents a bigger challenge than an ICD which has the advantage of electrodes inside the heart and, especially, inside the atrium. Accordingly, the design of a SubQ ICD is a difficult proposition given the technical challenges to sense and detect arrhythmias. [0009] Yet another challenge could be combining a SubQ ICD with an existing pacemaker (IPG) in a patient. While this may be desirable in a case where an IPG patient may need a defibrillator, a combination implant of SubQ ICD and IPG may result in inappropriate therapy by the SubQ ICD, which may pace or shock based on spikes from the IPG. Specifically, each time the IPG emits a pacing stimulus, the SubQ ICD may interpret it as a genuine cardiac beat. The result can be over-counting beats from the atrium, ventricles or both; or, because of the larger pacing spikes, sensing of arrhythmic signals (which are typically much smaller in amplitude) may be compromised. [0010] Thus, providing a robust detection in the presence of challenges presented by SubQ ICD requirements and the environment under which it is expected to perform calls for special considerations. [0011] Therefore, for these and other reasons, a need exists for an improved method and apparatus to reliably sense and detect arrhythmias, subcutaneously, while rejecting noise and other physiologic signals. SUMMARY OF THE INVENTION [0012] A method and apparatus is described which provides for an improved detection of arrhythmias via an ECG signal obtained from a SubQ ICD, with no endocardial or epicardial leads. Specifically, the invention includes utilizing signal crossings within a fixed time window with a threshold signal based on subcutaneous signal characteristics and subsequent generation and evaluation of a histogram to distinguish between noise, sinus rhythm and ventricular fibrillation. BRIEF DESCRIPTION OF THE DRAWINGS [0013] These and other features of the present invention will be appreciated as the same becomes better understood by reference to the following detailed description of the embodiments of the invention when considered in connection with the accompanying drawings, in which like numbered reference numbers designate like parts throughout the figures thereof, and wherein: [0014] FIG. 1 depicts a SubQ ICD implanted in a patient; [0015] FIG. 2 depicts a frontal and side view of a SubQ ICD and an electrical lead body associated therewith; [0016] FIG. 3 is a circuit diagram of an embodiment of the circuitry of the SubQ ICD in accordance with the present invention. [0017] FIG. 4 is a block diagram representing the sensing circuitry of the SubQ ICD in accordance with the present invention. [0018] FIG. 5 a is a representation of signals for normal sinus rhythm derived from a subcutaneous ECG signal; [0019] FIG. 5 b is a representation of signals for ventricular fibrillation derived from a subcutaneous ECG signal; [0020] FIG. 5 c is a representation of noise signals derived from a subcutaneous ECG signal; and [0021] FIG. 6 is a simplified flow diagram illustrating the method of detection of arrhythmias by the SubQ ICD in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION [0022] FIG. 1 shows SubQ ICD 14 implanted in patient 12 . The SubQ ICD 14 is subcutaneously implanted outside the ribcage of patient 12 , anterior to the cardiac notch. Further, a subcutaneous sensing and cardioversion/defibrillation therapy delivery lead 28 in electrical communication with SubQ ICD 14 , is tunneled subcutaneously into a location adjacent to a portion of a latissimus dorsi muscle of patient 12 . Specifically, lead 28 is tunneled subcutaneously from the median implant pocket of SubQ ICD 14 laterally and posterially to the patient's back to a location opposite the heart such that the heart 16 is disposed between the SubQ ICD 14 and the distal electrode coil 29 of lead 28 . [0023] Further referring to FIG. 1 , programmer 20 is shown in telemetric communication with SubQ ICD 14 by RF communication link 24 such as Bluetooth, WiFi, MICS, or as described in U.S. Pat. No. 5,683,432 “Adaptive Performance-Optimizing Communication System for Communicating with an Implantable Medical Device” to Goedeke, et al and incorporated herein by reference in its entirety. [0024] FIG. 2 is a frontal and plan view of SubQ ICD 14 . SubO ICD 14 is an ovoid and includes a substantially kidney-shaped profile forming a housing with connector 25 for attaching a subcutaneous sensing and cardioversion/defibrillation therapy delivery lead 28 . SubQ ICD 14 may be constructed of stainless steel, titanium or ceramic as described in U.S. Pat. Nos. 4,180,078 “Lead Connector for a Body Implantable Stimulator” to Anderson and 5,470,345 “Implantable Medical Device with Multi-layered Ceramic Enclosure” to Hassler, et al. The electronics circuitry of SubQ ICD 14 may be incorporated on a polyamide flex circuit, printed circuit board (PCB) or ceramic substrate with integrated circuits packaged in leadless chip carriers and/or chip scale packaging (CSP). The plan view shows the ovoid construction that promotes ease of subcutaneous implant. This structure is ergonomically adapted to minimize patient discomfort during normal body movement and flexing of the thoracic musculature. [0025] The electronic circuitry employed in SubQ ICD 14 can take any of the known forms that detect a tachyarrhythmia from the sensed ECG and provide cardioversion/defibrillation shocks as well as post-shock pacing as needed while the heart recovers. A simplified block diagram of such circuitry adapted to function employing the first and second and, optionally, the third cardioversion-defibrillation electrodes as well as the ECG sensing and pacing electrodes described herein below is set forth in FIG. 3 . It will be understood that the simplified block diagram does not show all of the conventional components and circuitry of such ICDs including digital clocks and clock lines, low voltage power supply and supply lines for powering the circuits and providing pacing pulses or telemetry circuits for telemetry transmissions between the SubQ ICD 14 and external programmer 20 . [0026] FIG. 3 depicts the electronic circuitry including low voltage and high voltage batteries within the hermetically sealed housing of SubQ ICD 14 . The low voltage battery 353 is coupled to a power supply (not shown) that supplies power to the SubQ ICD 14 circuitry and the pacing output capacitors to supply pacing energy in a manner well known in the art. The low voltage battery can comprise one or two conventional LiCF x , LiMnO 2 or Lil 2 cells. The high voltage battery 312 can comprise one or two conventional LiSVO or LiMnO 2 cell. [0027] Further referring to FIG. 3 , SubQ ICD 14 functions are controlled by means of software, firmware and hardware that cooperatively monitor the ECG, determine when a cardioversion-defibrillation shock or pacing is necessary, and deliver prescribed cardioversion-defibrillation and pacing therapies. The block diagram of FIG. 3 incorporates circuitry set forth in commonly assigned U.S. Pat. Nos. 5,163,427 “Apparatus for Delivering Single and Multiple Cardioversion and Defibrillation Pulses” to Keimel and 5,188,105 “Apparatus and Method for Treating a Tachyarrhythmia” to Keimel for selectively delivering single phase, simultaneous biphasic and sequential biphasic cardioversion-defibrillation shocks typically employing an ICD IPG housing electrode coupled to the COMMON output 312 of high voltage output circuit 340 and one or two cardioversion-defibrillation electrodes disposed posterially and subcutaneously and coupled to the HVI and HV-2 outputs ( 313 and 323 , respectively) of the high voltage output circuit 340 . The circuitry of the SubQ ICD 14 of the present invention could be simplified by adoption of one such cardioversion-defibrillation shock waveform for delivery between the first and second cardioversion-defibrillation electrodes 313 and 323 coupled to the HV-I and HV-2 outputs respectively. Alternatively, the third cardioversion-defibrillation electrode 332 can be coupled to the COMMON output as shown in FIG. 3 and the first and second cardioversion-defibrillation electrodes 313 and 323 can be electrically connected in to the HV-I and the HV-2 outputs, respectively, as depicted in FIG. 3 . [0028] The cardioversion-defibrillation shock energy and capacitor charge voltages can be intermediate to those supplied by ICDs having at least one cardioversion-defibrillation electrode in contact with the heart and most AEDs having cardioversion-defibrillation electrodes in contact with the skin. The typical maximum voltage necessary for ICDs using most biphasic waveforms is approximately 750 Volts with an associated maximum energy of approximately 40 Joules. The typical maximum voltage necessary for AEDs is approximately 2000-5000 Volts with an associated maximum energy of approximately 200-360 Joules depending upon the model and waveform used. The SubQ ICD of the present invention uses maximum voltages in the range of about 700 to about 3150 Volts and is associated with energies of about 25 Joules to about 210 Joules. The total high voltage capacitance could range from about 50 to about 300 microfarads. Such cardioversion-defibrillation shocks are only delivered when a malignant tachyarrhythmia, e.g., ventricular fibrillation is detected through processing of the far field cardiac ECG employing one of the available detection algorithms known in the ICD art. [0029] In FIG. 3 , pacer timing/sense amplifier circuit 378 processes the far field ECG SENSE signal that is developed across a particular ECG sense vector defined by a selected pair of the electrodes 332 , 313 and, optionally, electrode 323 if present as noted above. The selection of the sensing electrode pair is made through the switch matrix/MUX 390 in a manner to provide the most reliable sensing of the EGM signal of interest, which would be the R wave for patients who are believed to be at risk of ventricular fibrillation leading to sudden death. The far field ECG signals are passed through the switch matrix/MUX 390 to the input of a sense amplifier in the pacer timing/sense amplifier circuit 378 . Bradycardia is typically determined by an escape interval timer within the pacer timing circuit 378 or the timing and control circuit 344 , and pacing pulses that develop a PACE TRIGGER signal applied to the pacing pulse generator 392 when the interval between successive R-waves exceeds the escape interval. Bradycardia pacing is often temporarily provided to maintain cardiac output after delivery of a cardioversion-defibrillation shock that may cause the heart to slowly beat as it recovers back to normal function. [0030] Detection of a malignant tachyarrhythmia is determined in the timing and control circuit 344 as a function of the intervals between R-wave sense event signals that are output from the pacer timing/sense amplifier circuit 378 to the timing and control circuit 344 . It should be noted that the present invention utilizes not only the interval based signal analysis method but also the histogram signal processing method and apparatus as described hereinbelow. [0031] Certain steps in the performance of the detection algorithm criteria are cooperatively performed in microcomputer 342 , including microprocessor, RAM and ROM, associated circuitry, and stored detection criteria that may be programmed into RAM via a telemetry interface (not shown) conventional in the art. Data and commands are exchanged between microcomputer 342 and timing and control circuit 344 , pacer timing/amplifier circuit 378 , and high voltage output circuit 340 via a bidirectional data/control bus 346 . The pacer timing/amplifier circuit 378 and the timing and control circuit 344 are clocked at a slow clock rate. The microcomputer 342 is normally asleep, but is awakened and operated by a fast clock by interrupts developed by each R-wave sense event or on receipt of a downlink telemetry programming instruction or upon delivery of cardiac pacing pulses to perform any necessary mathematical calculations, to perform tachycardia and fibrillation detection procedures, and to update the time intervals monitored and controlled by the timers in pace/sense circuitry 378 . [0032] The algorithms and functions of the microcomputer 342 and timer and control circuit 344 employed and performed in detection of tachyarrhythmias are set forth, for example, in commonly assigned U.S. Pat. Nos. 5,354,316 “Method and Apparatus for Detection and Treatment of Tachycardia and Fibrillation” to Keimel; 5,545,186 “Prioritized Rule Based Method and Apparatus for Diagnosis and Treatment of Arrhythmias” to Olson, et al, 5,855,593 “Prioritized Rule Based Method and Apparatus for Diagnosis and Treatment of Arrhythmias” to Olson, et al and 5,193,535 “Method and Apparatus for Discrimination of Ventricular Tachycardia from Ventricular Fibrillation and Treatment Thereof” to Bardy, et al, (all incorporated herein by reference in their entireties). Particular algorithms for detection of ventricular fibrillation and malignant ventricular tachycardias can be selected from among the comprehensive algorithms for distinguishing atrial and ventricular tachyarrhythmias from one another and from high rate sinus rhythms that are set forth in the '316, '186, '593 and '593 patents. [0033] The detection algorithms are highly sensitive and specific for the presence or absence of life threatening ventricular arrhythmias, e.g., ventricular tachycardia (V-TACH) and ventricular fibrillation (V-FIB). Another optional aspect of the present invention is that the operational circuitry can detect the presence of atrial fibrillation (A FIB) as described in Olson, W. et al. “Onset And Stability For Ventricular Tachyarrhythmia Detection in an Implantable Cardioverter and Defibrillator,” Computers in Cardiology (1986) pp. 167-170. Detection can be provided via R-R Cycle length instability detection algorithms. Once A-FIB has been detected, the operational circuitry will then provide QRS synchronized atrial cardioversion/defibrillation using the same shock energy and wave shapes used for ventricular cardioversion/defibrillation. [0034] Operating modes and parameters of the detection algorithm are programmable and the algorithm is focused on the detection of V-FIB and high rate V-TACH (>180 bpm). Although SubQ ICD 14 of the present invention may rarely be used for an actual sudden death event, the simplicity of design and implementation allows it to be employed in large populations of patients at relatively little or no risk with modest cost by medical personnel other than electrophysiologists. Consequently, SubQ ICD 14 of the present invention includes the automatic detection and therapy of the most malignant rhythm disorders. As part of the detection algorithm's applicability to children, the upper rate range is programmable upward for use in children, known to have rapid supraventricular tachycardias and more rapid V-FIB. [0035] When a malignant tachycardia is detected, high voltage capacitors 356 , 358 , 360 , and 362 are charged to a pre-programmed voltage level by a high-voltage charging circuit 364 . It is generally considered inefficient to maintain a constant charge on the high voltage output capacitors 356 , 358 , 360 , 362 . Instead, charging is initiated when control circuit 344 issues a high voltage charge command HVCHG delivered on line 345 to high voltage charge circuit 364 and charging is controlled by means of bi-directional control/data bus 366 and a feedback signal VCAP from the HV output circuit 340 . High voltage output capacitors 356 , 358 , 360 and 362 may be of film, aluminum electrolytic or wet tantalum construction. [0036] The negative terminal of high voltage battery 312 is directly coupled to system ground. Switch circuit 314 is normally open so that the positive terminal of high voltage battery 312 is disconnected from the positive power input of the high voltage charge circuit 364 . The high voltage charge command HVCHG is also conducted via conductor 349 to the control input of switch circuit 314 , and switch circuit 314 closes in response to connect positive high voltage battery voltage EXT B+ to the positive power input of high voltage charge circuit 364 . Switch circuit 314 may be, for example, a field effect transistor (FET) with its source-to-drain path interrupting the EXT B+ conductor 318 and its gate receiving the HVCHG signal on conductor 345 . High voltage charge circuit 364 is thereby rendered ready to begin charging the high voltage output capacitors 356 , 358 , 360 , and 362 with charging current from high voltage battery 312 . [0037] High voltage output capacitors 356 , 358 , 360 , and 362 may be charged to very high voltages, e.g., 700-3150V, to be discharged through the body and heart between the selected electrode pairs among first, second, and, optionally, third subcutaneous cardioversion-defibrillation electrodes 313 , 323 , and 332 . The details of the voltage charging circuitry are also not deemed to be critical with regard to practicing the present invention; one high voltage charging circuit believed to be suitable for the purposes of the present invention is disclosed. High voltage capacitors 356 , 358 , 360 , and 362 are charged by high voltage charge circuit 364 and a high frequency, high-voltage transformer 368 as described in detail in commonly assigned U.S. Pat. No. 4,548,209 “Energy Converter for Implantable Cardioverter” to Wielders, et al. Proper charging polarities are maintained by diodes 370 , 372 , 374 and 376 interconnecting the output windings of high-voltage transformer 368 and the capacitors 356 , 358 , 360 , and 362 . As noted above, the state of capacitor charge is monitored by circuitry within the high voltage output circuit 340 that provides a VCAP, feedback signal indicative of the voltage to the timing and control circuit 344 . Timing and control circuit 344 terminates the high voltage charge command HVCHG when the VCAP signal matches the programmed capacitor output voltage, i.e., the cardioversion-defibrillation peak shock voltage. [0038] Timing and control circuit 344 then develops first and second control signals NPULSE 1 and NPULSE 2 , respectively, that are applied to the high voltage output circuit 340 for triggering the delivery of cardioverting or defibrillating shocks. In particular, the NPULSE 1 signal triggers discharge of the first capacitor bank, comprising capacitors 356 and 358 . The NPULSE 2 signal triggers discharge of the first capacitor bank and a second capacitor bank, comprising capacitors 360 and 362 . It is possible to select between a plurality of output pulse regimes simply by modifying the number and time order of assertion of the NPULSE 1 and NPULSE 2 signals. The NPULSE 1 signals and NPULSE 2 signals may be provided sequentially, simultaneously or individually. In this way, control circuitry 344 serves to control operation of the high voltage output stage 340 , which delivers high energy cardioversion-defibrillation shocks between a selected pair or pairs of the first, second, and, optionally, the third cardioversion-defibrillation electrodes 313 , 323 , and 332 coupled to the HV-I, HV-2 and optionally to the COMMON output as shown in FIG. 3 . [0039] Thus, SubQ ICD 14 monitors the patient's cardiac status and initiates the delivery of a cardioversion-defibrillation shock through a selected pair or pairs of the first, second and third cardioversion-defibrillation electrodes 313 , 323 and 332 in response to detection of a tachyarrhythmia requiring cardioversion-defibrillation. The high HVCHG signal causes the high voltage battery 312 to be connected through the switch circuit 314 with the high voltage charge circuit 364 and the charging of output capacitors 356 , 358 , 360 , and 362 to commence. Charging continues until the programmed charge voltage is reflected by the VCAP signal, at which point control and timing circuit 344 sets the HVCHG signal low terminating charging and opening switch circuit 314 . Typically, the charging cycle takes only fifteen to twenty seconds, and occurs very infrequently. The SubQ ICD 14 can be programmed to attempt to deliver cardioversion shocks to; the heart in the manners described above in timed synchrony with a detected R-wave or can be programmed or fabricated to deliver defibrillation shocks to the heart in the manners described above without attempting to synchronize the delivery to a detected R-wave. Episode data related to the detection of the tachyarrhythmia and delivery of the cardioversion-defibrillation shock can be stored in RAM for uplink telemetry transmission to an external programmer as is well known in the art to facilitate in diagnosis of the patient's cardiac state. A patient receiving the ICD 10 on a prophylactic basis would be instructed to report each such episode to the attending physician for further evaluation of the patient's condition and assessment for the need for implantation of a more sophisticated and long-lived ICD. [0040] SubO ICD 14 desirably includes telemetry circuit (not shown in FIG. 3 ), so that it is capable of being programmed by means of external programmer 20 via a 2-way telemetry link 24 (shown in FIG. 1 ). Uplink telemetry allows device status and diagnostic/event data to be sent to external programmer 20 for review by the patient's physician. Downlink telemetry allows the external programmer via physician control to allow the programming of device function and the optimization of the detection and therapy for a specific patient. Programmers and telemetry systems suitable for use in the practice of the present invention have been well known for many years. Known programmers typically communicate with an implanted device via a bidirectional radio-frequency telemetry link, so that the programmer can transmit control commands and operational parameter values to be received by the implanted device, and so that the implanted device can communicate diagnostic and operational data to the programmer. Programmers believed to be suitable for the purposes of practicing the present invention include the Models 9790 and CareLink® programmers, commercially available from Medtronic; Inc., Minneapolis, Minnesota. Various telemetry systems for providing the necessary communications channels between an external programming unit and an implanted device have been developed and are well known in the art. Telemetry systems believed to be suitable for the purposes of practicing the present invention are disclosed, for example, in the following U.S. Patents: U.S. Pat. No. 5,127,404 to Wyborny et al. entitled “Telemetry Format for Implanted Medical Device”; U.S. Pat. No. 4,374,382 to Markowitz entitled “Marker Channel Telemetry System for a Medical Device”; and U.S. Pat. No. 4,556,063 to Thompson et al. entitled “Telemetry System for a Medical Device”. The Wyborny et al. '404, Markowitz '382, and Thompson et al. '063 patents are commonly assigned to the assignee of the present invention, and are each hereby incorporated by reference herein in their respective entireties. [0041] FIG. 4 shows a block diagram 400 relating to the signal processing aspects of the invention The ECG signal 401 from the distal electrode 29 of subcutaneous lead 28 and the electrode on the SubQ ICD 14 is amplified and bandpass filtered (0.67-30 Hz) by amplifier 402 located in Pacer Timing/Amps 378 of FIG. 3 . Narrow band amplifier/filter 402 is desirably a finite impulse response filter (FIR). Rectifier block 404 performs full wave rectification on the amplified signal from bandpass filter 402 . A level waveform is derived from the narrowband signal at processing block 406 . A programmable fixed threshold, a moving average or, alternatively, an auto-adjusting threshold is generated as described in U.S. Pat. No. 5,117,824 “Apparatus for Monitoring Electrical Physiologic Signals” to Keimel, et al incorporated herein by reference in its entirety. A comparator 406 determines signal crossings from the selected and generated threshold from level block 408 . Microprocessor 342 , control circuit 344 and programs located in RAM/ROM generate a histogram with 10 ms bins, for example, of signal crossings in adjacent two-second windows at block 410 . A single or several histograms from adjacent windows are evaluated to allow detection of normal sinus rhythm, physiologic noise signals, sinus tachycardia, ventricular tachycardia and/or ventricular fibrillation. The examples shown are two-second windows, but other window sizes may be used. It is likely that a window size between two and 10 seconds would provide best performance and a desired window size is three seconds. A programmable n of m (i.e., 2 of 3) criteria is used to make the final determination of VF or VT versus non-life-threatening signals. [0042] FIG. 5A shows a two-second window 500 with a rectified and filtered subcutaneous normal sinus rhythm signal 502 . The auto-adjusting threshold waveform is also shown at 504 . Rising edge crossings between the subcutaneous signal and the auto-adjusting threshold are depicted at 506 . Histograms of the signal crossings are shown for a two-second window at 510 . Note that normal sinus rhythm generates regular consistent peaks 512 in consecutive two-second windows (for purposes of simplicity, drawing shows one window only). [0043] FIG. 5B shows a two-second window 520 with a rectified and filtered subcutaneous ventricular fibrillation signal 522 . The auto-adjusting threshold waveform is also shown at 524 . Rising edge crossings between the subcutaneous signal and the auto-adjusting threshold are depicted at 526 . Histograms of the signal crossings are shown for a two-second window at 530 . Note that ventricular fibrillation generates a gaussian (i.e., bell shaped) distribution 532 centered around 100 mSec in consecutive two-second windows. [0044] FIG. 5C shows a two-second window 540 with a rectified and filtered physiologic noise signal (i.e., myopotentials) 542 . The auto-adjusting threshold waveform is also shown at 544 . Rising edge crossings between the subcutaneous signal and the auto-adjusting threshold are depicted at 546 . Histograms of the signal crossings are shown for a two-second window at 550 . Note that noise signals generates high frequency occurrence 552 of short interval crossings (range 15-75 mSec) in consecutive two-second windows. [0045] FIG. 6 is a simplified flow diagram 600 illustrating a process of detection of arrhythmias in accordance with the present invention. At step 602 the subcutaneous signal from lead 28 and canister 14 or from bilpolar electrodes on canister periphery is bandpass filtered (0.67-30 Hz) and full wave rectified at step 604 . A threshold signal is generated at step 606 . This threshold may be programmed/selected from a constant value (percentage of peak value), a moving average and an auto-adjusting threshold value. At step 610 a two-second timer is evaluated. The duration of this timer corresponds to the desired window size and is set to two-seconds for this example. As noted above, a window size between 2 and 10 seconds is desired. If the two-second timer has not completed its timeout, the flow diagram continues to evaluate/compare rectified signals versus the threshold signal/level. If at step 610 , the two-second timer is completed, a two-second histogram is generated at step 612 . The histogram is evaluated at step 614 and a determination is made whether the subcutaneous signals presented are normal sinus rhythm (regular consistent peaks at longer intervals), ventricular fibrillation (bell shaped gaussian curve near 100 mSec) or noise (high frequency occurrence of short intervals such as 15-75 mSec). A reconfirmation of diagnosis is made at step 616 by considering several adjacent histograms and comparing to a programmable criteria, n similar diagnosis of m adjacent histograms (i.e., 2 of 3). If the diagnosis is not confirmed based on the criteria, the flow diagram returns to step 602 and repeats the signal evaluation process as described hereinabove. If at step 616 , the n of m test is affirmatively confirmed, then a pre-programmed therapy is delivered at step 618 , as required. After therapy is delivered at step 618 , the flow diagram returns to step 602 . [0046] It will be apparent from the foregoing that while particular embodiments of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of application Ser. No. 14/188,101, filed Feb. 24, 2014, now allowed, which is a divisional of International Application No. PCT/US2013/027982, filed Feb, 27, 2013, which claims the benefit of U.S. Provisional Application Ser. No. 61/604,410, filed Feb,28, 2012, and U.S. Provisional Application Ser. No. 61/666,835, filed Jun, 30, 2012, each of which is hereby incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a trainable nutraceutical beverage mixing system and method for operating the same. More particularly, the present invention relates to a customizable supplement beverage system, and method for personalizing the same to a particular user and for tracking of the same. The invention also relates to multi-compartment pods or containers for use with the trainable beverage mixing system. [0004] 2. Description of the Related Art [0005] Industrial applications of trainable computer systems are known in the art, and typically include user-preference memorization. Also known are customized nutritional food and beverage dispensing systems, such as the one in U.S. Pat. No. 7,762,181 (Boland et al.), the entire contents of which are incorporated by reference. [0006] As discussed in detail in Boland '181 a highly complex ingredient processor blends, cooks and prepares in an individual dose system requiring continuous update and complex operational steps. Unfortunately, this reference processor blends, cooks and prepares in an individual dose system requiring continuous update and complex operational steps. Unfortunately, this reference fails to identify the trainable operation desired of the present invention, system and method. Also detriment to '181 is a substantially high cost requirement for a dispensing system which prohibits individual-use systems. [0007] Accordingly, there is a need for an improved trainable nutraceutical beverage mixing system and method of operating the same. Further, there is also a need to improve process efficiencies in tracking, identifying, dispensing and monitoring individually customizable supplement programs matched with a user's needs. There is also a need for a portable beverage mixing system including multi-component containers for use therewith. ASPECTS AND SUMMARY OF THE INVENTION [0008] In response, the present invention provides a trainable nutraceutical beverage system. Provided is a customizable supplement beverage system, and method for personalizing and operating the same to a particular user and for operative tracking Proposed additionally is an operative system for receiving and individually identifying a concentrate or supplement combinations, for mixing the same prior to a use, and for dispensing the same for use, and for tracking control factors relating to the same. Also proposed is a personalized supplement program that is beverage based for user convenience. [0009] Also proposed are various portable mixing systems with safety controls according to the preferred embodiment of the present invention with the system. Preferably, the systems comprise a housing body having a pod or container receiving portion with a slip resistant bottom surface. Alternatively, bottom surface may be a type of key-in surface to lock or otherwise secure the pod or container in place during operation. The preferred pods or containers for use with the invention will be discussed in greater detail below. Optionally, the mixing system may have safety controls to alert the user to a particular speed or frequency of the mixing based upon the type of nutraceutical being used or the size or amount being used. A user access code, fingerprint scan, retina scan or other known type of safety control mechanisms that are difficult to bypass, including software safety control, may be employed with the system, especially for the consumption of quantity-sensitive materials (i.e., Iron, etc.) to prevent accidental overdose. The mixing system further comprises a movable mixing head comprising a back head movably connected to a front mixing head which includes a stirrer or mixer. [0010] During operation, after the pod or container is positioned securely on the surface, the mixing head is lowered such that the mixer or stirrer is engaged with an upper component of the pod or container. The user then selects the appropriate control for the desired frequency or speed of the mixing. Optionally, the front mixing head, which is connected to the back head via one or more movable arms such that the mixing arm moves about within the pod or container. Similarly, the mixing head may also optionally partially rotate (e.g., approximately 45%, 60%, 75%, etc.) again to move the mixing arm around within container or pod. Optionally, the mixing or agitation may additionally involve varying the depth of the engagement between the mixing paddle and the beverage, varying the duration of the mixing or agitation, reversing and/or oscillating the direction of the mixing (i.e., clockwise, counterclockwise, clockwise, etc.), and/or oscillating the depth of the engagement between the mixing paddle and the beverage (i.e., up, down, up, down, etc.). [0011] Preferably, internal (not shown) to the mixing system is an internal process controller unit (including suitable memory and processing units) optionally linked with an external communication control system. As will be understood by those of skill in the system operational arts, during any use, system may be able to track individual uses, dispensements, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the communication control system may be able to communicate externally to process control system and data tables and with the delivery supply system, thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, the system may be able to re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0012] Also proposed are various embodiments for two compartment mixing pods or containers and some of their components that may be employed with the various mixing systems discussed above. For example, a first embodiment of a pod or container for use with the mixing systems previously described, illustrates a two part pod, a nutritional supplement part and a housing part for containing filtered water, with a mixing paddle having radially projecting blades or fans and a upwardly projecting stem for interfacing with the disclosed mixing systems. Preferably, an upper part of the pod has a sealing cap having a sealing membrane or protective label there on. Optionally, a protective label may contain a 2D or 3D barcode thereon for the mixing system to read, store and/or transmit information about the product being used. Also optionally, a lid or cap is secured onto an upper portion of the housing part in a tamper resistant manner such that if the seal is broken the average user would notice. [0013] Preferably, the pod or portion pack is made substantially of recyclable materials. Also, the multiple parts of the pod or pack are preferably embodied as an assembly all of which are molded of the same material (e.g., polyethylene, etc.) which can be disposed of and recycled as an assembly. This is advantageous because it simplifies the waste stream through eliminating the identification and separation of unlike materials. [0014] During operation, once the pod or container is positioned securely into the mixing system, a mixing head will lower the mixing arm or stirrer down onto the upper portion or protective label of the pod or container. The mixing system will continue to move mixing arm downward until the lower end of the mixing arm connects or otherwise engages with the upper end of a stem of the paddle such that when the mixing arm spins, the paddle will rotate at the same speed and/or frequency. The mixing arm continues to apply downward pressure on the stem until a lower tip of the paddle punctures the sealing membrane which had been maintaining the nutritional supplement or vitamin away from the water. Once the sealing membrane is punctured the nutritional supplement or vitamin spills into the water and the mixing arm continues to apply downward pressure on the stem until the paddle is sufficiently submerged to a distance within the water to adequately and completely mix the water and nutritional supplement as described above with respect to any of the mixing systems disclosed herein. Once sufficiently mixed, the mixing arm rises out from within the container so that the container may be removed from the mixing system. Optionally, the mixing arm and/or stem may comprise a mechanism or may be configured in such a way that they become securely engaged and that when the mixing arm is removed from container, it removes the paddle as well. Optionally, the paddle may remain within the container and be disposed of along with the container once all of the liquid mixture is gone. [0015] The above and other aspects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings, in which like reference numerals designate the same elements. BRIEF DESCRIPTION OF THE DRAWINGS [0016] A further understanding of the present invention can be obtained by reference to a preferred embodiment set forth in the illustrations of the accompanying drawings. Although the illustrated preferred embodiment is merely exemplary of methods, structures and compositions for carrying out the present invention, both the organization and method of the invention, in general, together with further objectives and advantages thereof, may be more easily understood by reference to the drawings and the following description. The drawings are not intended to limit the scope of this invention, which is set forth with particularity in the claims as appended or as subsequently amended, but merely to clarify and exemplify the invention. [0017] For a more complete understanding of the present invention, reference is now made to the following drawings in which: [0018] FIG. 1 is a descriptive illustration of one alternative embodiment of the proposed system; [0019] FIG. 2 is an illustrative flow chart of one alternative method according to one embodiment of the proposed invention; [0020] FIG. 3A is a front plan view of the portable mixing system with safety controls according to the preferred embodiment of the present invention with the system in the raised or open position; [0021] FIG. 3B is a top plan view of the mixing system shown in FIG. 3A ; [0022] FIG. 3C is a side view of the mixing system shown in FIG. 3A ; [0023] FIG. 4A is a front plan view of the portable mixing system shown in FIG. 3A with the system in the lowered or closed position; [0024] FIG. 4B is a side view of the mixing system shown in FIG. 4A ; [0025] FIG. 5A is a front plan view of the portable mixing system with safety controls according to an alternate embodiment of the present invention; [0026] FIG. 5B is a top plan view of the mixing system shown in FIG. 5A ; [0027] FIG. 5C is a side view of the mixing system shown in FIG. 5A ; [0028] FIG. 6A is a front plan view of the portable mixing system with safety controls according to another alternate embodiment of the present invention; [0029] FIG. 6B is a side view of the mixing system shown in FIG. 6A ; [0030] FIG. 7A is a front plan view of the portable mixing system with safety controls according to another alternate embodiment of the present invention; [0031] FIG. 7B is a side view of the mixing system shown in FIG. 7A ; [0032] FIG. 8A is a front plan view of the portable mixing system with safety controls according to another alternate embodiment of the present invention; [0033] FIG. 8B is a side view of the mixing system shown in FIG. 8A ; [0034] FIG. 9A is a closed front plan view of the preferred embodiment for a two part pod with a mixing paddle therein for use with the mixing system according to the invention; [0035] FIG. 9B is an exposed cross-sectional view of the two part pod shown in FIG. 9A further showing the mixing paddle; [0036] FIG. 9C is an exposed cross-sectional view of the two part pod shown in FIG. 9A further showing the mixing paddle; [0037] FIG. 9D is a top plan view of the cap or lid for use with the two part pod shown in FIGS. 9A-C ; [0038] FIG. 10 is an exposed cross-sectional view of an alternative embodiment for a two part pod for use with the mixing system according to the invention; [0039] FIG. 11A is a descriptive illustration of phase one of a bi-pod filtration process used with the system according to one aspect of the invention; [0040] FIG. 11B is a descriptive illustration of phase two of a bi-pod filtration process used with the system according to one aspect of the invention; [0041] FIG. 12 is an exploded perspective view of an alternative embodiment for a two part spin pod for use with the mixing system in accordance with the invention; [0042] FIG. 13A is a perspective view of a first embodiment for a stir pod spinning mechanism in the closed position for use in mixing the contents of the spin pod during operation of the mixing system; [0043] FIG. 13B is a perspective view of the stir pod spinning mechanism shown in FIG. 13A but shown in the open position; [0044] FIG. 14A is a perspective view of a second embodiment for a stir pod spinning mechanism in the closed position having three blades for use in mixing the contents of the spin pod during operation of the mixing system; [0045] FIG. 14B is a perspective view of the stir pod spinning mechanism shown in FIG. 14A but shown in the open position; [0046] FIG. 14C is a perspective view of the stir pod spinning mechanism shown in FIG. 14A but shown in the open position and having only two stirring blades; [0047] FIG. 15A is a perspective view of a third embodiment for a stir pod spinning mechanism for use in mixing the contents of the spin pod during operation of the mixing system; [0048] FIG. 15B is a perspective view of the stir pod spinning mechanism shown in FIG. 15A further indicating the flow of liquid during spinning in order to mix the contents of the spin pod; [0049] FIG. 16 is a perspective view of one embodiment of how the stir pods may be packaged for proper sealing and safety; [0050] FIG. 17A is a front plan view of yet another alternative embodiment for a two part pod for use with the mixing system in accordance with the invention; [0051] FIG. 17B is an exposed cross-sectional view of the two part pod shown in FIG. 17A further showing the membrane piercing component upon compression of the two part pod; [0052] FIG. 17C is a perspective view of one embodiment of the membrane piercing component for use with the invention; [0053] FIG. 17D is a perspective view of an alternate embodiment of the two part pod shown in FIGS. 17A-B ; [0054] FIG. 18A is a front plan view of yet another alternative embodiment for a two part pod for use with the mixing system in accordance with the invention; [0055] FIG. 18B is an exposed cross-sectional view of the two part pod shown in FIG. 18A further showing multiple membrane piercing component upon compression of the two part pod; [0056] FIG. 18C is a perspective view of an alternate embodiment of the two part pod shown in FIGS. 18A-B ; and [0057] FIG. 19 is a front plan view of still another alternative embodiment for a two part pod or compartment for use with the mixing system in accordance with the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0058] As required, a detailed illustrative embodiment of the present invention is disclosed herein. However, techniques, systems, compositions and operating structures in accordance with the present invention may be embodied in a wide variety of sizes, shapes, forms and modes, some of which may be quite different from those in the disclosed embodiment. Consequently, the specific structural and functional details disclosed herein are merely representative, yet in that regard, they are deemed to afford the best embodiment for purposes of disclosure and to provide a basis for the claims herein which define the scope of the present invention. [0059] Reference will now be made in detail to embodiments of the invention. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps. The drawings are in simplified form and are not to precise scale. The word ‘couple’ and similar terms do not necessarily denote direct and immediate connections, but also include connections through intermediate elements or devices. For purposes of convenience and clarity only, directional (up/down, etc.) or motional (forward/back, etc.) terms may be used with respect to the drawings. These and similar directional terms should not be construed to limit the scope in any manner. It will also be understood that other embodiments may be utilized without departing from the scope of the present invention, and that the detailed description is not to be taken in a limiting sense, and that elements may be differently positioned, or otherwise noted as in the appended claims without requirements of the written description being required thereto. [0060] Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments of the present invention; however, the order of description should not be construed to imply that these operations are order dependent. [0061] Referring now to FIG. 1 , the proposed system 100 includes an operable process control system and operable data tables 102 that is in communication with a delivery and supply system 101 for management of system 100 as will be discussed. As will be understood from the exemplary illustration an optional data communication loop is provided by illustrated arrows, but this will be understood by those of skill in the art to be operable over any known telecommunication process for receipt, manipulation, and delivery of information, and for tracking physical delivery of later described items. [0062] Within system 100 there is provided a user-unit operable for receipt of a concentrate or supplement container 1 and a supply of a dilutant (e.g., water, coffee, tea, milk, carbonated beverages, any hot or cold fluid, or any other suitable fluid) 2 , with operable power input access 3 (at rear of unit) and a control system 4 containing suitable controls for achieving the goals of the proposed system (including but not limited to on/off, volume control, temp, control, mixing proportions, optional weight-stage for dispensing tracking etc.). Both container 1 and dilutant 2 may be in multi-use, continuous, or single-use sizes. [0063] Additionally noted is a dispensing station unit 5 for supporting a volume to receive a mixture of dilutant 1 and concentrate 2 under mixing conditions controlled by control system 4 . An individual tracking identification or bar code 6 is provided on each concentrate/supplement container 1 and there is positioned an associated reader 7 for receiving identification/use information from code 6 during an installation and use of container 1 . Internal (not shown) to the location unit is an internal process controller unit 8 (including suitable memory and processing units) linked with an optional external communication control system 9 . As will be understood by those of skill in the system operational arts, during any use, system 100 will be able to track individual uses, dispensments, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the end unit and communication control system 9 will be able to communicate externally to process control system and data tables 102 and with delivery supply system 101 , thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, system 100 will be able to optionally re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0064] Regarding process control system and data tables 102 , it will be understood that these include a comprehensive process control units to receive, track, organize, and select from informational data bases involving comprehensive user identifications, complete medical and query information and user goals, a complete selection with all parameters of dilutants and also all supplements, minerals, pharmaceuticals etc. that may be selected based upon user-parameters. [0065] Referring now to FIG. 2 wherein an operative and optional method of the proposed system is illustrated. In a first step 201 an initial determination is provided of user preferences and needs and includes (in each step noted hereafter) links with process and data control unit and system 102 containing operative communication links 102 A. Such determination step may include questionnaires (multiple) following family history, health concerns, health history, desired outcomes (weight loss, muscle gain, medical treatment support (e.g., diabetes, wound healing, cancer treatment support, etc. without limitations thereto). [0066] Following initial questionnaire and detail information for each individualized users an initial recommended user-unique supplement determination is made in a step 202 linked with a unique identification step 203 and via process and data control system 102 , a supplement concentrate product is created, packaged, and shipped in a combined step 204 to a user for installation in a device 205 . Device system 100 recognizes the unique identification and conducts local controls and monitoring as discussed elsewhere through continuous use steps 206 for a designated period of time (user determined, medically determined etc.) until a desire to conduct a secondary determination step 207 is reached. [0067] In step 207 a link with the unique identification is made via path 210 to process control 102 and the historic data is stored in data tables therewith. Additional steps in a rebalancing step 208 are conducted that would include modifying the initial supplement determination step 202 and crafting a replacement or secondary supplement via a path 209 shown also linked with process control 102 . In this matter, during a rebalancing step a new individually identifiable supplement is packaged, shipped, delivered, linked with the system and dispensed therefrom. [0068] It will be recognized that this process of initial determination and later rebalancing may be repeated without limit so as to provide a continual trainable process unique to each user's needs. [0069] Further, it will be understood that the entire contents of the incorporated-by-reference U.S. Pat. No. 7,762,181 is available to access for enabling content upon question by one of skill in the art. Additionally, it will be understood that this application will incorporate the currently known highest skill in the communication, data management, shipping, user-identification and product-identification technologies in the art. Thus, for a non-limiting example where data is “sent” or “recorded” this will be understood to incorporate all known ways (wired, wireless, encrypted, open, random-access memory, bubble-memory, cloud-based etc.). For example, the current process control system and data tables could be cloud-based, or located on a proprietary enterprise type system with server modules. Finally, it will be understood that the full health, medical, vitamin, pharmaceutical, and nutrition data available and is used to guide supplement or concentrate and dilutant determination. [0070] It will be understood that the phrase dilutant supply or dilutant may be any fluid material that is not the nutraceutical concentration, thereby allowing a dilution of the concentration during a use dispensment. The dilutant may be any suitable fluid for human consumption, and by way of non-limiting example the dilutant may be water or another combination of components (e.g., coffee, tea, milk, pharmaceutical combinations etc., without limitation). [0071] It will be understood that the phrase nutraceutical, indicates a portmanteau of the words “nutrition” and “pharmaceutical”, and as used herein is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease, and that this food or food product may be of any kind, but is preferably in the form of a fluid concentrate intended for combination with water prior to ingestion by an end user. Nothing herein will limit the interpretation to requiring a pharmaceutical product. It will also be understood that nutraceutical may additionally include those compounds, vitamins, flavorings, minerals, drugs, or pharmaceutical compositions (without limit to any) that are believed to have a physiological benefit or provide protection against chronic disease. With recent developments in cellular-level nutraceutical agents the proposed use will be understood as non-limiting and is to be broadly interpreted to include any complementary and alternative therapies now known or later developed. [0072] Turning next to FIGS. 3A-C and 4 A- 4 B, shown are the portable mixing system with safety controls according to the preferred embodiment of the present invention with the system in the raised or open position ( FIGS. 3A-C ) and in the lowered or closed position ( FIGS. 4A-B ). Preferably, the system comprises a housing body 318 having a pod or container receiving portion 312 with a slip resistant bottom surface 310 . Alternatively, bottom surface 310 may be a type of key-in surface to lock or otherwise secure the pod or container 316 in place during operation. The preferred pods or containers 316 for use with the invention will be discussed in greater detail below. Optionally, the mixing system 300 may have safety controls 314 to alert the user to a particular speed or frequency of the mixing based upon the type of nutraceutical being used or the size or amount being used. Mixing system 300 further comprises movable mixing head 320 comprising back head 302 movably connected to front mixing head 304 which includes stirrer or mixer 306 . [0073] During operation, after pod or container 316 is positioned securely on surface 310 , mixing head 320 is lowered (see FIGS. 4A-B ) such that mixer or stirrer 306 is inserted into the contents of the pod or container 316 . The user then selects the appropriate control 314 for the desired frequency or speed of the mixing. Optionally, front mixing head, which is connected to back head 302 via movable arms 308 such that mixing arm 306 moves about within pod or container 316 . Similarly, the mixing head 320 may also optionally partially rotate (e.g., approximately 45% or 60%) again to move mixing arm 306 around within container or pod 316 . [0074] Preferably, internal (not shown) to the mixing system 300 is an internal process controller unit (including suitable memory and processing units) optionally linked with an external communication control system. As will be understood by those of skill in the system operational arts, during any use, system 300 may be able to track individual uses, dispensements, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the communication control system may be able to communicate externally to process control system and data tables and with delivery supply system, thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, system 300 may be able to re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0075] Referring next to FIGS. 5A-C , shown is the portable mixing system with safety controls according to an alternate embodiment of the present invention. Preferably, the system comprises a housing body 418 having a pod or container receiving portion 412 with a slip resistant bottom surface 410 . Alternatively, bottom surface 410 may be a type of key-in surface to lock or otherwise secure the pod or container in place during operation. The preferred pods or containers for use with the invention will be discussed in greater detail below. Optionally, the mixing system 400 may have power control switch 422 and safety controls 414 (e.g., one for mom, one for dad, and one for child) to identify for or alert the user to a particular speed or frequency of the mixing based upon the type of nutraceutical or other health product being used or the size or amount being used. Optionally, a user access code, fingerprint scan, retina scan or other known type of safety control mechanisms that are difficult to bypass, including software safety control, may be employed with the system, especially for the consumption of quantity-sensitive materials (i.e., Iron, etc.) to prevent accidental overdose. Mixing system 400 further comprises movable mixing head 420 movably connected within housing 418 and is connected on its bottom surface to stirrer or mixing arm 406 . [0076] During operation, after a pod or container is positioned securely on surface 410 , mixing head 420 is lowered such that mixing arm or stirrer 406 is inserted into the contents of the pod or container. The user then selects the appropriate control 414 for the desired frequency or speed of the mixing. As will be discussed further below, the mixing arm 406 may optionally have fans or blades which extend radially from mixing arm 406 to aid in the mixing process. Optionally, the mixing head 420 may also move up and down as well as partially rotate within housing 418 (e.g., approximately 45% or 60%) again to move mixing arm 406 around within the container or pod. [0077] As discussed above, internal (not shown) to the mixing system 400 is preferably an internal process controller unit (including suitable memory and processing units) optionally linked with an external communication control system. In addition, a barcode reader or scanner 404 may be included to read and transmit information from the product being used to the internal process controller unit. As will be understood by those of skill in the system operational arts, during any use, system 400 may be able to track individual uses, dispensements, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the communication control system may be able to communicate externally to process control system and data tables and with the delivery supply system, thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, system 400 may be able to re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0078] Turning next to FIGS. 6A-B , shown is the portable mixing system 500 with safety controls according to yet another alternate embodiment of the present invention. Preferably, the system comprises a housing body 518 having a pod or container receiving portion 512 with a slip resistant bottom surface 510 . Alternatively, bottom surface 510 may be a type of key-in surface to lock or otherwise secure the pod or container in place during operation. The preferred pods or containers for use with the invention will be discussed in greater detail below. Optionally, the mixing system 500 may have a power control switch and safety controls 514 (e.g., one for mom, one for dad, and one for child) to identify for or alert the user to a particular speed or frequency of the mixing based upon the type of nutraceutical or other health product being used or the size or amount being used. Alternatively, an LED or other touch based electronic screen 504 may be employed to provide all the control menus and options for the user of the system. Mixing system 500 further comprises mixing head 520 connected to housing 518 directly above container receiving portion 512 and is connected to stirrer or mixing arm 506 . [0079] During operation, after a pod or container is positioned securely on surface 510 , mixing head 520 lowers mixing arm or stirrer 506 into the contents of the pod or container. The user then selects the appropriate control 514 (or using other control pad 504 ) for the desired frequency or speed of the mixing. As will be discussed further below, the mixing arm 506 may optionally have fans or blades which extend radially from mixing arm 506 to aid in the mixing process. Optionally, the mixing head 520 may also move up and down as well as partially rotate within housing 518 (e.g., approximately 45% or 60%) again to move mixing arm 506 around within the container or pod. [0080] As discussed above with the other embodiments, internal (not shown) to the mixing system 500 is preferably an internal process controller unit (including suitable memory and processing units) optionally linked with an external communication control system. In addition, a barcode reader or scanner 508 may be included to read and transmit information from the product being used to the internal process controller unit. As will be understood by those of skill in the system operational arts, during any use, system 500 may be able to track individual uses, dispensements, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the communication control system may be able to communicate externally to process control system and data tables and with delivery supply system, thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, system 500 may be able to re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0081] Turning next to FIGS. 7A-B , shown is the portable mixing system 600 with safety controls according to still yet another alternate embodiment of the present invention. Preferably, the system comprises a housing body 618 having a pod or container receiving portion 612 with a slip resistant bottom surface 610 . Alternatively, bottom surface 610 may be a type of key-in surface to lock or otherwise secure the pod or container in place during operation. The preferred pods or containers for use with the invention will be discussed in greater detail below. Optionally, the mixing system 600 may have a power control switch 622 and safety controls 614 (e.g., one for mom, one for dad, and one for child) to identify for or alert the user to a particular speed or frequency of the mixing based upon the type of nutraceutical or other health product being used or the size or amount being used. Alternatively, an LED or other touch based electronic screen 604 may be employed to provide all the control menus and options for the user of the system. Mixing system 600 further comprises mixing head 620 , in this embodiment a ball-shaped head, connected to housing 618 directly above container receiving portion 612 and is connected to stirrer or mixing arm 606 . [0082] Again, during operation, after a pod or container is positioned securely on surface 610 , mixing head 620 lowers mixing arm or stirrer 606 into the contents of the pod or container. The user then selects the appropriate control 614 (or using other control pad 604 ) for the desired frequency or speed of the mixing. Mixing system 600 may optionally employ a locking mechanism or child safety lock to prevent a child from accidentally selecting an adult size or speed. As will be discussed further below, the mixing arm 606 may optionally have fans or blades which extend radially from mixing arm 606 to aid in the mixing process. Optionally, the mixing head 620 may also move up and down as well as partially rotate within housing 618 (e.g., approximately 45% or 60%) again to move mixing arm 606 around within the container or pod. [0083] As discussed above with the other embodiments, internal (not shown) to the mixing system 600 is preferably an internal process controller unit (including suitable memory and processing units) optionally linked with an external communication control system. In addition, a barcode reader or scanner 508 may be included to read and transmit information from the product being used to the internal process controller unit. As will be understood by those of skill in the system operational arts, during any use, system 600 may be able to track individual uses, dispensements, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the communication control system may be able to communicate externally to process control system and data tables and with delivery supply system, thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, system 600 may be able to re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0084] Referring now to FIGS. 8A-B , shown is the portable mixing system 700 with safety controls according to still another alternate embodiment of the present invention. Preferably, the system comprises a housing body 718 having a pod or container receiving portion 712 with a slip resistant bottom surface 710 . Alternatively, bottom surface 710 may be a type of key-in surface to lock or otherwise secure the pod or container in place during operation. The preferred pods or containers for use with the invention will be discussed in greater detail below. Optionally, the mixing system 700 may have a power control switches 722 and safety controls 714 (e.g., one for mom, one for dad, and one for child) to identify for or alert the user to a particular speed or frequency of the mixing based upon the type of nutraceutical or other health product being used or the size or amount being used. Alternatively, an LED or other touch based electronic screen 704 may be employed to provide all the control menus and options for the user of the system. Mixing system 700 further comprises a mixing head (not seen) within the upper portion of housing 718 connected to directly above container receiving portion 712 and which is connected to or integral with stirrer or mixing arm 706 (also not seen). [0085] During operation, after a pod or container is positioned securely on surface 710 , mixing head lowers mixing arm or stirrer 706 into the contents of the pod or container. The user then selects the appropriate control 714 (or using other control pad 704 ) for the desired frequency or speed of the mixing. Mixing system 700 may optionally employ a locking mechanism or child safety lock to prevent a child from accidentally selecting an adult size or speed. As will be discussed further below, the mixing arm 706 may optionally have fans or blades which extend radially from mixing arm 706 to aid in the mixing process. Optionally, the mixing head may also move up and down as well as partially rotate within housing 718 (e.g., approximately 45%, 60%, 75%, etc.) again to move mixing arm 706 around within the container or pod. [0086] As discussed above with the other embodiments, internal (not shown) to the mixing system 700 is preferably an internal process controller unit (including suitable memory and processing units) optionally linked with an external communication control system. In addition, a barcode reader or scanner 708 may be included to read and transmit information from the product being used to the internal process controller unit. As will be understood by those of skill in the system operational arts, during any use, system 700 may be able to track individual uses, dispensements, particular mixing proportions, total supplement delivery and other operations. Additionally, in an optional embodiment, the communication control system may be able to communicate externally to process control system and data tables and with delivery supply system, thereby permitting comprehensive benefit, use, and adaptation tracking for a user's health benefit. Additionally, system 700 may be able to re-order, and operate commercial transactions on behalf of a user based upon designated user preferences. [0087] Turning our attention now to FIGS. 9 through 19 , shown are various embodiment for pods or containers and some of their components that may be employed with the various mixing systems discussed above with respect to FIGS. 3 through 8 . Referring first to FIGS. 9A-9D , show is a first embodiment of a pod or container 800 for use with the mixing systems previously described, illustrating a two part pod 800 ( 802 , 804 ), a nutritional supplement part 810 and a housing part 804 for containing filtered water 814 , with a mixing paddle 806 having radially projecting blades or fans and a upwardly projecting stem 808 for interfacing with the disclosed mixing systems. The nutritional supplement or vitamin supplement contained within nutritional supplement part 810 for any of the embodiments disclosed herein may be in the form of powder, liquid, dissolvable capsules or tablets, microcapsules, or other known form. [0088] Preferably, upper part 810 of pod 800 has a sealing cap 802 having a sealing membrane or protective label 816 there on. Optionally, protective label 816 contains a 2D or 3D barcode thereon as seen in FIG. 9D for the mixing system to read, store and/or transmit information about the product being used. Also optionally, lid or cap 802 is secured onto an upper portion of housing part 804 in a tamper resistant manner such that if the seal is broken the average user would notice. Any of the known tamper resistant mechanisms for bottles or containers may be employed. [0089] During operation, once pod or container 800 is positioned securely into the mixing system, a mixing head lowers the mixing arm or stirrer down onto the upper portion or protective label 816 of pod or container 800 . The mixing system will continue to move mixing arm downward until the lower end of the mixing arm connects or otherwise engages with the upper end of stem 808 of paddle 806 such that when mixing arm spins, paddle 806 will rotate at the same speed and/or frequency. Mixing arm continues to apply downward pressure on stem 808 until a lower tip 807 of paddle 806 punctures sealing membrane 812 which had been maintaining nutritional supplement or vitamin 810 away from water 814 . Once sealing membrane 812 is punctured nutritional supplement or vitamin 810 spills into water 814 and mixing arm continue to apply downward pressure on stem 808 until paddle 806 is sufficiently submerged to a distance within water 814 to adequately and completely mix the water and nutritional supplement as described above with respect to any of the mixing systems disclosed herein. Once sufficiently mixed, the mixing arm rises out from within container 800 so that container 800 may be removed from the mixing system. Optionally, mixing arm (see any of FIGS. 3 through 8 ) and/or stem 808 may comprise a mechanism or may be configured in such a way that they become securely engaged and that when the mixing arm is removed from container 800 , it removes paddle 806 as well. Optionally, paddle may remain with container and be disposed of along with container once all the liquid mixture is gone. [0090] Turning next to FIG. 10 , shown is an exposed cross-sectional view of an alternative embodiment for a two part pod or container 820 for use with the mixing systems in accordance with the invention. In this embodiment, two part pod or container 820 comprises outer container 828 housing liquid (e.g., 3 or 4 ounces of water) and inner container or baggie 826 housing the nutritional supplement blend or vitamins 836 . Inner container 826 is preferably heat-sealed on its upper end to the upper end of outer container 828 . Outer container 828 may preferably be a blow molded polyurethane (PE) bottle or any other suitable container material for foods. An injection molded PE cap 832 is preferably affixed on the outer side of upper end of outer container 828 and includes an injection molded lance 830 through its top surface such that lance 830 has a lower bladed end within baggie 826 and an upper end extending outwardly through cap 832 . Adjacent the outer top side of cap 832 is preferably positioned a compression spring 822 which is surrounded by a film 824 heat sealed to cap and covering spring 822 . Compression spring 822 is configured such that it maintains lance 830 in position until a downward force is applied during use. [0091] As previously discussed, during operation, once pod or container 820 is positioned securely into the mixing system, a mixing head will lower the mixing arm or stirrer down onto the upper portion directly above spring 22 pod or container 820 . The mixing system will continue to move its mixing arm downward until the lower end of the mixing arm connects or otherwise engages with the upper end of lance 830 . The mixing arm continues to apply downward pressure on upper end of lance 830 until a lower tip of lance 830 punctures the lower end of baggie 826 . Once broken, nutritional supplement or vitamin 836 spills into water 834 and mixing arm continue to apply downward pressure on lance 830 until sufficiently submerged to a distance within water 834 to adequately and completely mix the water and nutritional supplement as described above with respect to any of the mixing systems disclosed herein. Once sufficiently mixed, the mixing arm rises out from within container 820 so that container 820 may be removed from the mixing system. Optionally, mixing arm (see any of FIGS. 3 through 8 ) and/or lance 830 may comprise a mechanism or may be configured in such a way that they become securely engaged and that when the mixing arm is removed from container 820 , it removes lance 830 as well. Optionally, lance 830 may remain with container and be disposed of along with container once all the liquid mixture is gone. [0092] Referring next to FIGS. 11A-B , shown are descriptive illustrations of phase one and phase two of a bi-pod filtration process used with the system according to one aspect of the invention. [0093] Looking now at FIG. 12 , shown is an exploded perspective view of another alternative embodiment for a two part spin pod for use with the mixing system in accordance with the invention. As shown, two part pod 840 comprises housing or container 848 for hold liquid, and stir pod 845 comprising upper shaft 842 (preferably of a hex shape or some other shape such that secure interface may be made with the lower end of a mixing arm), side portions 844 and mixing paddle 846 . During operation, once pod or container 840 is positioned securely into the mixing system, a mixing head will lower the mixing arm or stirrer down onto the upper portion directly above and engages upper shaft 842 without applying too much pressure. The mixing system will then begin rotation of the mixing arm thereby rotating stir pod 845 . [0094] Depicted in FIGS. 13 through 15 are alternative embodiments for the stir pod used in conjunction with the spin pod 840 shown in FIG. 12 . For example, FIGS. 13A-B shows stir pod 850 in its closed ( FIG. 13A ) and its open ( FIG. 13B ) positions. During use, the centrifugal force from rotation of stir pod 850 from engaging the mixing arm of one of the above described mixing systems generates sufficient centrifugal force to open blades 852 thereby spilling the nutritional supplement blend therefrom and into the liquid in the container below. Blades 852 are then used to mix the water and nutritional supplement. Similarly, FIGS. 14A-C shows stir pods 854 , 860 (stir pod 860 only having two blades) in closed ( FIG. 14A ) and open ( FIG. 14B-C ) positions. During use, pressure applied to tabs 856 during rotation of stir pods 854 , 860 open blades 858 , 862 thereby spilling the nutritional supplement blend therefrom and into the liquid in the container below. Blades 858 , 862 are then used to mix the water and nutritional supplement. Looking at FIGS. 15A-B shown is another alternate embodiment for a stir pod for use with the invention. That is, stir pod 864 comprises veins or inwardly opening blades 866 such that with rotation thereof water flows into the stir pod 864 and out through an opening 868 on a bottom end of stir pod 864 . During use, the centrifugal force from rotation of stir pod 884 from engaging the mixing arm of one of the above described mixing systems generates sufficient force to open blades 866 inwardly or allow water to break through a seal of some kind to mix with the nutritional supplement within stir pod 864 and flow out through its bottom thereby spilling the combined water-nutritional supplement blend from the stir pod 864 . Briefly, FIG. 16 shows a perspective view of one embodiment of how any of the spinning pods may be packaged for proper sealing and safe handling. [0095] As an alternative embodiment to the portable electronic mixing systems disclosed above, shown in FIG. 17A-C , 18 A-C and 19 describe various embodiments for a portable and disposable two part pod mixing system in accordance with the invention. [0096] Referring first to FIGS. 17A-D , shown is a first embodiment of a pod or container 900 . As illustrated, mixing container 900 preferably comprises a blow molded (P.P. or PET) housing 904 , which is heat sealed on its lower end 906 with a PP or foil membrane to a blow molded PP lower compressible container 910 . Preferably, housing 904 contains liquid (i.e., approximately 3 ounces of water) while lower collapsible container 910 contains the desired nutritional supplement. On its upper end, housing 904 is removably closed with a cap, such as the cap for an ordinary water bottle or soda bottle. Also optionally, lid or cap 902 is secured onto an upper portion of housing part 904 in a tamper resistant manner such that if the seal is broken the average user would notice. Any of the known tamper resistant mechanisms for bottles or containers may be employed. Of course, a larger lid configuration of container having a large lid such as container 901 may be used. [0097] Also, within lower collapsible container 910 is positioned, preferably affixed to the bottom surface thereof, a foil or membrane piercing divider 914 . Upon shaking or vigorous up and down motion of the container 900 , piercing divider 914 punctures ( 912 ) foil or membrane 908 thereby allowing the nutritional supplement in lower container 910 to mix with the water in housing 904 upon continued shaking Accordingly, while it is preferred that piercing divider 914 be configured as shown, i.e., in the shape of a pyramid, any shape divider which has a sharp enough apex would suffice. [0098] Turning to FIGS. 18A-B , shown is a second embodiment of a two compartment mixing pod or container 920 . As illustrated, mixing container 920 here preferably comprises a blow molded (P.P. or PET) housing 924 , which is heat sealed on its lower end with a PP or foil membrane to a blow molded PP lower compressible container 930 . Preferably, housing 924 contains liquid (i.e., approximately 3 ounces of water) while lower collapsible container 930 contains the desired nutritional supplement. On its upper end, housing 924 is removably closed with a tamper resistant heat sealed pull off lid 922 , such as the pull off lid for a container of yogurt. [0099] Also, within lower collapsible container 930 is positioned, preferably affixed to the bottom surface thereof, a foil or membrane piercing divider 934 . Upon shaking or vigorous up and down motion of the container 920 , piercing divider 934 punctures the foil or membrane thereby allowing the nutritional supplement in lower container 930 to mix with the water in housing 924 upon continued shaking Accordingly, while it is preferred that piercing divider 934 be configured as shown, i.e., in the shape of a pyramid, any shape divider which has a sharp enough apex would suffice. Moreover, while two piercing dividers are shown, other numbers of dividers may be used with the invention. [0100] As seen in FIG. 18C , yet another alternate embodiment of the two part mixing pod is shown. Here, pod 920 comprises on its lower end an expandable lower region 926 which on its lower end is heat sealed to lower collapsible compartment 928 . In this embodiment, upon shaking or vigorous up and down motion of the container 920 , a piercing divider, much like divider 934 seen in FIG. 18B punctures the foil or membrane thereby allowing the nutritional supplement in lower container 928 to mix with the water in housing 924 upon continued shaking Preferably, upon puncture of the membrane, lower compartment 928 compresses or collapses while at the same time or close to the same time expanding region 926 of pod 920 expands to allow for extra space with housing 924 upon entry of the nutritional supplement. [0101] Similar to the embodiment just described with respect to FIG. 18C , yet another alternate embodiment of the two part mixing pod is shown in FIG. 19 , which is similar to the two compartment pods shown in FIGS. 17A-B but with the added expandable region 946 . Here, pod 940 comprises on its lower end an expandable lower region 946 which on its lower end is heat sealed 938 to lower collapsible compartment 948 . In this embodiment, upon shaking or vigorous up and down motion of the container 940 , a piercing divider, much like divider 934 seen in FIG. 18B , punctures the foil or membrane thereby allowing the nutritional supplement in lower container 948 to mix with the water in housing 944 upon continued shaking Preferably, upon puncture of the membrane, lower compartment 948 compresses or collapses while at the same time or close to the same time expanding region 946 of pod 940 expands to allow for extra space within housing 944 for entry of the nutritional supplement. Alternatively, pod 940 may be held by a machine at 950 . The machine would compress lower compartment 948 , then shaking pod 940 such that expanding region 946 expands. [0102] In the claims, means or step-plus-function clauses are intended to cover the structures described or suggested herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, for example, although a nail, a screw, and a bolt may not be structural equivalents in that a nail relies on friction between a wooden part and a cylindrical surface, a screw's helical surface positively engages the wooden part, and a bolt's head and nut compress opposite sides of a wooden part, in the environment of fastening wooden parts, a nail, a screw, and a bolt may be readily understood by those skilled in the art as equivalent structures. [0103] Having described at least one of the preferred embodiments of the present invention with reference to the accompanying drawings, it will be apparent to those skilled in the art that the invention is not limited to those precise embodiments, and that various modifications and variations can be made in the presently disclosed system without departing from the scope or spirit of the invention. Thus, it is intended that the present disclosure cover modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents. The scope of the invention, therefore, shall be defined solely by the following claims. It should be appreciated that the present invention is capable of being embodied in other forms without departing from its essential characteristics.

1a

COPYRIGHT NOTICE [0001] A portion of the disclosure of this patent contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a bottom surface substrate for an aquarium. In particular, the present invention relates to a molded aquarium substrate with optional aquarium decoration attachment means. [0004] 2. Description of Related Art [0005] Display aquariums generally use some sort of substrate at the bottom of the aquarium tank for securing aquarium decorations, providing a natural looking environment, maintaining an environmental balance and generally providing a pleasing and artistic appearance of the aquarium. Typically, the bottom surface substrate of an aquarium is a granular material such as sand, gravel, aragonite, cichlid and coral. Other artificial granular materials are used including polymeric granular materials which can be easily colored and can even be made luminescent. These materials are relatively hard, dense to remain at the bottom and of relatively medium size particle. While these materials have been used for decades now in the display of fish, small retiles, and other aquatic and land creatures they present some problems in terms of maintenance and cleaning. The biggest problem comes when the aquarium is cleaned. The granular substrate must be removed, cleaned and dealt with which leads to spills difficulty in cleaning and a general mess. While these problems are certainly a source of frustration and work for the aquarium owner, the lack of alternatives has led most people to accept the limitations of the current substrate materials. [0006] One important reason for a lack of alternatives is the ability of the current substrates to effectively act as an anchor for decorative items. These items include things such as artificial and live plants, ornamental articles and the like that act to create a particular environment from natural to fanciful in nature. Typically a decorative item is partially buried in a substrate to anchor it. Water currents, the density and weight of the particular decoration and the environment (especially with water) in general however create difficulties in not only placement of articles but in keeping the decorative items stationary once placed. [0007] Live plants have been anchored with weights attached to the plant and items such as flat disks, etc have been added to mounting devices to attach other items. The majority of means to secure decorations work under ideal conditions but are inadequate with a more challenging environment, especially with larger fish or reptiles. As a result frequent adjustment and replacement has been necessary. One solution to the attachment problem has been disclosed in U.S. Pat. No. 5,855,982 to Wechsler Issued Jan. 5, 1999. In this patent there is described an anchoring accessory which includes a support element for reception of plants, a means for selectively positioning the accessory at one of a series of specific locations and a means for fastening an article to a support element. The claimed device is designed to work under and with granular substrate materials and while it does provide a means to anchor decorations it does nothing to avoid the problems with granular substrate materials. [0008] While the problems with aquariums are not as great when the environment is not an aquatic one, the problems encountered with cleaning anchoring and the like are still significant. It is clear that since the problems with current substrates have existed for decades that the art is desperate for new solutions to this problem. SUMMARY OF THE PRESENT INVENTION [0009] It has been discovered that an aquarium bottom surface substrate can be made from a combination of granular substrate and polymeric material. The material substrate solves long standing problems with cleaning aquarium substrates. Waste is not forced down into the granular material and cleaning can be done with the substrate in place. In addition, anchoring of aquarium decorations can be done in a fixed way that is part of the substrate and not an additional part that must be used in conjunction with loose granular material. [0010] Accordingly one embodiment of the invention comprises an aquarium bottom surface substrate comprising: a) a granular substrate material; and b) a biocompatible polymeric material molded to fit the bottom surface of an aquarium; wherein the granular substrate material is embedded into the molded polymeric material such that a portion of the granular material extends from the surface of the polymeric material. [0013] Yet another embodiment of the present invention comprises a kit of parts comprising: a) an aquarium substrate comprising a granular substrate material and a biocompatible polymeric material molded to fit the bottom surface of an aquarium wherein the granular substrate material is embedded into the molded polymeric material such that a portion of the granular material extends from the surface of the polymeric material; b) a plurality of means for attaching aquarium decorations to the substrate; and c) at least one aquarium decoration capable of attaching to the attaching means. [0017] As can be seen there are many embodiments and one skilled in the art can modify the teachings and embodiments consistent with the teaching herein. Other benefits and surprising utility of the present invention will be further seen from the description of the invention which follows. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 is a perspective view of an embodiment of the invention [0019] FIG. 2 a is a perspective view of an attachment means of the invention with a matching decorative aquarium piece. [0020] FIG. 2 b is a perspective view of an alternative embodiment of the attachment means for aquarium decorations. [0021] FIG. 2 c is a perspective view of an alternative embodiment of the attachment means with a push on decoration. [0022] FIG. 3 a is a partial side view of the present invention with an embedded attachment means and granular material only on the top. [0023] FIG. 3 b is a partial side view of the present invention with a through the polymer attachment means and the granular material evenly distributed. [0024] FIG. 3 c is a partial side view of the present invention with an attachment means and a decorative plant attached thereto and granular material partially distributed throughout the polymer. [0025] FIG. 4 is an embodiment of the present invention with aquarium decorations and aquarium backdrop in an aquarium. [0026] FIG. 5 is a view of an embodiment comprising a lift out means to aid in removing the substrate from an aquarium. DETAILED DESCRIPTION OF THE INVENTION [0027] The present invention relates to an aquarium substrate consisting of a granular aquarium substrate fixed into a polymeric mat. It has been found that the appearance of the resulting substrate looks like the granular substrate alone however it is much easier to clean and very easy to remove when desired. This invention is a great step forward in that granular substrates have been used for decades and no suitable substitute has previously been found in spite of the limitations and problems with granular substrates for aquarium use. [0028] While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail specific embodiments, with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described. In the description below, like reference numerals are used to describe the same, similar or corresponding parts in the several views of the drawings. This detailed description defines the meaning of the terms used herein and specifically describes embodiments in order for those skilled in the art to practice the invention. [0029] The terms “a” or “an”, as used herein, are defined as one as or more than one. The term “plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). The term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. [0030] Reference throughout this document to “one embodiment”, “certain embodiments”, “and an embodiment” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or 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 without limitation. [0031] The term “or” as used herein is to be interpreted as an inclusive or meaning any one or any combination. Therefore, “A, B or C” means “any of the following: A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive. [0032] As used herein the term “aquarium bottom surface substrate” refers to material used at the bottom of aquariums for decorative purposes or to hold decorations and the like. Aquariums has its plain meaning and refers to glass and plastic containers usually open at the top and used primarily for aquatic animals but frequently used for small land animals such as small mammals, reptiles and the like. Where used without water, aquariums can also have side doors and the like for access to the animal and contents of the aquarium. While often terms such as vivarium and terrarium are used to describe other uses for aquariums for purposes of the discussion herein the term aquarium shall be considered inclusive of these and any related terms and devices. [0033] As used herein the term “granular substrate material” refers to those normally loose granular materials available to the art that are used as aquarium bottom surface substrate. This includes such natural materials (natural or colored) as sand and gravel and the like but also includes artificial materials such as polymeric gravel. [0034] As used herein the term “biocompatible polymeric material” refers to moldable polymers which can be cast into a flexible or rigid solid and are not toxic or injurious, or do not produce significant immunological response in living tissue of aquatic or animal life that may come in contact directly or indirectly with the polymer in an aquarium. In general, many biocompatible polymers are well known such as acrylic polymers for example the brand Acrylic Water and in view of this disclosure are selectable by one skilled in the art. Examples include but are not limited to polyurethanes, polycarbonates, silicone polymers, polyamides, polysulfones, polyvinyls, polyacrylics, polyesters, polyethers and the like. The present invention includes a single polymer or could include a blend of polymers for the exact properties desired and to have the highest compatibility with the granular substrate material. The polymeric material can be any color or opacity. In one embodiment the polymer is essentially clear when molded. [0035] The biocompatible material is “molded to fit the bottom surface of an aquarium. The bottom of an aquarium can literally be any size. Most aquariums are rectangular in shape but multi-sides and round aquariums are well known. In order to simulate familiar bottom surfaces the polymeric material will be molded to fit the particular aquarium it is to be used in. So for example where the bottom surface interior measurements are 2 foot by 6 inches the width and length of the polymeric material would be just short of those measurements to fit the bottom. The thickness of the polymeric material can be done as desired but in general between about ⅜ of an inch and about 2 inches and in another embodiment between about ¾ of an inch and 1¼ inch depending on the desired look of the final product. One skilled in the art could easily make the final determination and the above described dimensions are not intended to be limiting. [0036] The present invention aquarium bottom surface substrate is produced by embedding, for example by casting, molding or the like, a selected quantity of the granular substrate material into the polymeric material. The polymer then holds together the granular substrate. The amount of granular material selected is based on the particular look one desires with the present invention. Where replication of loose granular substrate is desired a large amount of granular substrate is added. Likewise a smaller amount can be added. In one embodiment the granular material protrudes from the surface of the polymeric material while in another it is entirely embedded in the material. In one embodiment the granular material is only on at least a portion of the polymeric material and in another embodiment it is distributed throughout the entire polymeric material. The granular substrate may be evenly distributed or may be distributed with varying amounts in different portions of the polymeric material. For example one may desire to have no granular substrate in the bottom portion of the polymeric material so the polymeric material may lie flat on the bottom surface of the aquarium. [0037] In a further embodiment of the invention there is an anchoring means associated with the present invention. The anchoring means could be anything embedded, attached or pushed through the polymeric material which then in turn a decorative item could be attached to. In one embodiment a snap means is pushed through the polymeric material from the bottom so that the snap means protrudes from the top surface of the polymer and granular material. Then a decorative item with a corresponding attachment means for the snap can be positioned and attached to the snap means. By having multiply holes or choosing a polymer which the attachment means can be pushed through or embedding attachment means into the polymer one or more decorations can be attached. The decorations thus attached are much more stable than those just placed on or in loose granular substrate but can easily be removed for replacement or cleaning. [0038] Since the present invention provides a means for the bottom substrate presentation the present invention could also include as an additional element, an aquarium background that by a selected means matches the present invention bottom surface substrate. One skilled in the art could easily select the backgrounds based on the present disclosure and the artistic needs of the background. [0039] In another embodiment the substrate could also be provided with a means to remove the substrate from an aquarium. Tabs, rings, tethers and the like could be employed to aid in lifting the substrate as desired. One embodiment is to use a through the substrate means with a ring or other grabbing means to grab and lift the substrate. [0040] The present invention can be presented as polymeric mat alone or can be sold as a kit of parts with the present invention, the attachment means and one or more attachable decorations. In addition, the kit of parts could include the above described aquarium background. [0041] Now referring to the drawings; FIG. 1 is a perspective of the present invention the aquarium bottom surface substrate 1 the polymeric material 2 is shown in this embodiment as clear rectangular molded polymer. It could be either a rigid or flexible polymer as desired. In this perspective granular material 5 is distributed within the polymeric material all the way to the bottom 10 of the polymeric material granular material 6 is embedded entirely within the polymeric material and does not extend to the bottom 10 . While the granular materials 5 and 6 are shown in only a portion of the polymer and distributed in two different ways one skilled in the art could either evenly or unevenly distribute the granular material as desired. The particular embodiment of the substrate 1 is shown with a height 20 , length 21 , and width. In this embodiment no decoration or attachment means are shown. [0042] FIG. 2 a is a perspective view of an attachment means of the invention with a matching decorative aquarium piece. The attachment means 31 has a base 32 , body shaft 33 and a snap means 34 . Aquarium decoration 40 is depicted as a crude artificial aquatic plant. It includes a decorative base 41 have an opening 42 which when the attachment means 31 is inserted into decorative piece bottom 43 moves up until snap means 34 moves into opening 42 holding it in place. The aquarium plant 45 is show for illustrative purposes and could be any aquarium decorative item with the attachment base 41 on it. [0043] FIG. 2 b shows an alternative embodiment of an attachment means. Attachment means 35 has a base 32 but has dual shafts 36 in a spread apart manner with dual snaps 37 . The attachment means 35 would attach to base 41 from FIG. 2 a in the same manner. While snap means are shown other attachments means could in view of the disclosure be used including things such as pressure fittings, O-ring attachments, tied on decorations and the like. In view of the disclosure one skilled in the art could design alternative attachment means without undue experimentation. [0044] FIG. 2 c depicts yet another embodiment of attachment means. In this view, attachment means 80 consists of shaft 83 and friction tip 84 . Suction base 85 is a suction means which will stick to the bottom of the aquarium. The corresponding decoration 86 has hallow shaft 87 which slides over shaft 83 and is held in place by the friction between tip 84 and the inside of hallow shaft 87 . [0045] FIGS. 3 a, 3 b and 3 c show partial side view of the polymer with embedded granular material showing various granular embeddings as well as different ways of using the attachment means with the present invention substrate. FIG. 3 a shows the attachment means 50 embedded within the polymeric material. Also granular material 61 is only embedded in the top surface 70 of the polymeric material. The remainder of the polymeric material 2 is without granular material 61 . In view 3 b the attachment means 51 is pushed through the polymeric material 2 . The base 32 protruding from the bottom 71 of polymeric material 2 . The base 32 could also be in a recess, not shown of the polymeric material so that the base 32 is flush with the bottom 71 of the polymeric material. In this view granular substrate 62 is evenly distributed in the polymeric material 2 . In FIG. 3 c once again an attachment means 52 is shown as through the polymeric material 2 with the base 32 outside the polymeric material bottom 71 . In this view a decorative plant 40 is attached to the attachment means 52 with the protrusion means 38 protruding through holes 42 , not visible from this view. The granular substrate 63 in this view is distributed in an upper portion of the polymeric material 2 leaving the bottom portion of the polymeric material 2 free of granular material 63 . Inn all of these views the selected polymer is a clear polymer but opaque and colors could also be selected as desired. [0046] FIG. 4 is an embodiment of the present invention in use in an aquarium with the optional aquarium backdrop. The present aquarium bottom substrate 1 consisting of granular material 90 and polymer 2 is placed in the bottom of aquarium 101 . The granular material 90 is shown as distributed throughout the polymer 2 . Also shown are two decorative plants attached to attachment means not shown as hidden underneath the base 41 of the decorative plant 40 . [0047] FIG. 4 also shows decorative backdrop 110 . The backdrop 110 is show without a particular design but could be a photograph, drawing color or any background typical for an aquarium. [0048] FIG. 5 depicts the substrate 1 with lift out means 50 . The lift out means 50 is similar to a decorative anchor but comprises a ring or other grabbing means that will enable the user to grab the means 50 and lift and remove the substrate 1 from an aquarium tank. One or more lift out means 50 can be provided as necessary. In one embodiment there are two lift out means. Decorations 51 can also be designed to attach to the lift out means 50 to hide or decorate the lift out means 50 . [0049] The drawings and the descriptions thereof are not intended to be limiting selection of attachment means granular substrate and polymer and the like can be selected based on the drawings and the disclosure and no such limitation should be read upon the claims which follow.

1a

FIELD OF THE INVENTION This invention relates to orthosis for regulating the movement of an associate body part and in particular, to orthopedic knee and elbow hinges providing facilitated adjustment to the arc of flexion and extension. BACKGROUND OF THE INVENTION Traditionally, orthopedic hinges were of two types, polycentric and single pivotal. Single pivot hinges permit changes in the flexion and extension angles when the pivot axis of the hinge and that of the limb are aligned. However, when these axes are not aligned, these devices apply a force or bending moment to the joint that can be both painful and deleterious to the success of orthopedic implants and other corrective surgery. Polycentric prostheses usually consist of two control arms having separate pivot points. See Castillo, U.S. Pat. No. 4,599,998, which is incorporated by reference. The control arms of Castillo operate through identical arcs of rotation and are mutually dependent on the same activation member. Castillo discloses an adjustable polycentric orthopedic appliance hinge having a rack cooperating with pinions formed at the ends of a pair of control arms. The device engages the arms in dependent relation with one another and with a drive member such that the rotational position of the arms, and thus the angle between them, is altered, upon translation of the drive member. The drive member of this device is combined with stops that limit the degree of the translation of the drive member in at least one direction and, preferably, in both directions. The stops are independently adjustable to provide a range of angular movement to the control arms. Devices such as that disclosed by Castillo have multi-hinge pivot points, however, there are frictional and bending forces created at the contact point between the teeth of the control arms and the drive member. These forces are translated to the joint and complicate the "tracking", or alignment with the joint. Moreover, when the control arms contact a stop point for either flexion or extension, the dependent engagement of the arms with the drive member creates stresses which can result in forward or backward pressure at the joint with attendant consequences. Freely, bi-pivotal prostheses, on the other hand, provide a greater distance between their pivot points, leaving a margin of error for positioning the knee within the appliance without creating bending moments at the knee joint. See Seton Products Inc., trade literature SET-1856-1585 RP disclosing the MASTER HINGE® brace. Bi-pivotal motion provides improved knee tracking by permitting changes in the angle between the control arms when the knee joint proceeds to a point at which the pivot points of the hinge and the joint are no longer aligned. The MASTER HINGE® design is positively adjustable for controlling extension and flexion of the knee. Despite its advantages, the MASTER HINGE® provides a complicated arrangement of two adjustment screws for each control arm for independently setting the extension and flexion arc of each arm. The hinge provides no mechanism for matching the flexion or extension of both arms simultaneously and relies on the skill and patience of a physician to match the arcs of restriction of the upper and lower control arms. Generally, if a mistake is made in matching the arcs and they are adjusted to be unequal, more stress will be created at the joint. It is further understood that physicians cannot readily determine what range of motion is provided by the arms without moving the arms about their pivots over their entire arc. This procedure takes considerably more time and requires a longer training period for acquainting physicians with its use. In fact it is understood that, one of the most common complaints provided by physicians using this device is that the product is too complicated to learn and use on a regular basis. Accordingly, there is a need for an orthopedic hinge that provides joint tracking capability while at the same time providing for matched arcs for flexion and extension of the control arms. There is also a need for an orthopedic hinge that is freely bi-pivotal, which also provides a less complicated adjustment means for varying the range of motion of the control arms. SUMMARY OF THE INVENTION An orthopedic hinge is provided having control arms which are free to rotate independent of one another. The hinge also includes a first and second adjustment means for simultaneously controlling each of the control arms to thereby define an arc of extension and an arc of flexion of an associated body part. Each of the control arms of this device have an arc of travel of about 30° to 120°, preferably 40° to 80°, and more preferably about 60°. This arc is ultimately limited by interfering portions of the preferred hinge housing. The device includes a preferred single adjustment screw for controlling the arc of flexion of both arms, and a preferred single adjustment screw for controlling the arc of extension of both arms. The preferred screws are preferably disposed in threaded engagement with wedge portions which are caused to move longitudinally along the screw. These wedge portions can be engaged with the control arms and moved along the screw because they contact the walls of the housing to preclude their rotation with the screws. Preferably, as the wedges move towards the center line defined by a pair of pivot points of said control arms, the degree of extension and flexion permitted by these control arms becomes reduced by reason of interference between the wedges and the control arms. It is, therefore, an object of this invention to provide an orthopedic hinge that minimizes bending moments created at joints due to misalignment of the alignment centers of the hinge and the joint. It is another object of this invention to provide an orthopedic hinge which is easier to use, and which can provide a reading for flexion setting and extension setting without undue experimentation. It is still another object of this invention to provide an orthopedic hinge that provides for matched arcs of rotation for both control arms while still providing for independent movement of the control arms within a given range of arc mobility. With these and other objects in view, which will become apparent to one skilled in the art as the description proceeds, this invention resides in the novel construction, combination, arrangement of parts and methods substantially as hereinafter described and more particularly defined in the attached claims. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings illustrate a complete embodiment of the invention according to the best mode for the best practical application of the principles thereof, and in which: FIG. 1: is a perspective drawing of the orthopedic hinge of this invention; FIG. 2: is a top view of the orthopedic hinge of FIG. 1; FIG. 3: is a enlarged, cross-sectional view taken through line 3--3 of FIG. 2, illustrating the internal elements of the orthopedic hinge of FIG. 1 including cut away views of the wedge portions of this embodiment; FIG. 4: is a transverse cross-sectional view of the embodiment of FIG. 2, taken through line 4--4 illustrating the preferred adjustment screws and wedges of this invention; FIG. 5: is a transverse view of the orthopedic hinge of FIG. 3, illustrating how one of the control arms impinges a wedge for creating flexion block. FIG. 6: is an enlarged view of the hinge embodiment of FIG. 1 illustrating the preferred scale and indicator means for determining the setting of the device. DESCRIPTION OF THE INVENTION According to this invention, an orthopedic hinge is provided comprising a housing, a pair of control arms rotatably mounted to the housing which are free to move independently of one another, a first adjustment means for simultaneously controlling these control arms to thereby define an arc of flexion and a second adjustment means for simultaneously controlling the control arms to thereby define an arc of extension. The invention preferably utilizes only two adjustment screws, one for regulating the arc of extension and one for regulating the arc of flexion of an associated body part. Preferably, the orthopedic hinge of this invention includes a scale on the housing which in conjunction with indicator means on the preferred wedges, provides a reading indicative of the degree of "flexion control" and "extension block" of the hinge. Referring now to the Figures, a preferred hinge embodiment 100 is provided. A housing 10, preferably constructed of stainless steel, and preferably AISI 303 stainless steel is depicted. The housing 10 is preferably constructed with a face plate. The housing 10 and face plate ideally are made from investment castings to provide a greater degree of accuracy of movement of the hinge 100. As illustrated in FIGS. 1 and 3, a pair of control arms 12 and 14 are rotatably mounted to the housing 10. The control arms 12 and 14 are free to move independently of one another with unimpinged bi-polar movement between the interfering portions 30. This invention includes a first adjustment means having a first element for simultaneously controlling the pair of control arms 12 and 14 to thereby define an arc of flexion of an associated body part. Also included is a second adjustment means having a second element for simultaneously controlling the pair of control arms 12 and 14 to thereby define an arc of extension of the body part. Interfering portions 30, which are preferably an integral part of the housing 10, are designed to limit the maximum arc of rotations for each of the control arms 12 and 14. Further according to this invention, the first element of the first adjustment means can comprise a first single adjustment screw 31 for adjusting an arc of rotation of the pair of control arms 12 and 14 during flexion of the body part. The first adjustment means can also comprise a first wedge portion 40 within the housing 10 for engaging and limiting the arc of rotation of the pair of control arms 12 and 14 during flexion of the body part. The second adjustment means of this invention preferably comprises a second single adjustment screw 33 for adjusting an arc of rotation of the pair of control arms 12 and 14 during extension. The second adjustment means can further comprise a second wedge portion 42 within the housing 10 for engaging and limiting the arc of rotation of the pair of control arms 12 and 14 during extension. As in the case of the housing 10, these wedge portions 40 and 42 are preferably investment cast from AISI 303 stainless steel. As described in FIG. 4, the preferred arrangement of the hinge includes the first wedge portion 40 disposed in threaded engagement with the first single adjustment screw 31 and the second wedge portion 42 disposed in threaded engagement with the second single adjustment screw 33. The control arms 12 and 14 of this invention are preferably freely bi-pivotal. By this, it is meant that the first arm 14 of said pair of control arms rotates about a first pivot point 51 and the second arm 12 rotates about a second pivot point 52. The first and second pivot points 51 and 52 are preferably located within the housing 10. Ideally, the first and second adjustment screws 31 and 33 are located along an axis bisecting the first and second pivot points 51 and 52. As depicted FIG. 3, control arms 12 and 14 preferably are constructed with arm holding castings 13 and 17 for engaging the first and second wedge portions 40 and 42. These castings 13 and 17 are preferably AISI 303 stainless steel investment castings and are fastened to control arms 12 and 14 with fasteners 19, which are preferably stainless steel rivets. The control castings 13 and 17 preferably comprise projections 22 and 24 for engaging the first and second wedge portions 40 and 42, as substantially described in FIGS. 3 and 5. In order to minimize the weight of the overall hinge 100, the arms 12 and 14 can be constructed of light weight metal, such as aluminum or magnesium, preferably 6061 aluminum in a T-6 heat-treated condition. The arms 14 and 17, once positioned in the preferred control castings 13 and 17, are free to rotate about pivot points 51 and 52. Further according to FIG. 3, a block member 50 is provided which can be attached to an interior portion of the housing 10 for engaging with the end portions of the first and second single adjustment screws 31 and 33. Preferably the block 50 is disposed so that the first and second wedge portions 40 and 42 slidably overlap its top surface. This is not a requirement, however, this arrangement may provide more stability to the wedges 40 and 42 when adjusted by screws 31 and 33. Referring again to FIG. 4, illustrating a cross-sectional view of the hinge 100 of FIG. 2, the operation of the adjustment screws 31 and 33 can now be explained. According to one embodiment of this invention, the head portion of each of the screws is disposed in complementary formed regions 43 and 45 of the hinge housing 10 such that a rotation of the screws 31 and 33 does not result in a longitudinal translation of the screws 31 and 33 within the housing 10. Also according to this embodiment, the first and second wedge portions 40 and 42 can comprise a surface 61 or 63 for engaging with the housing 10 and for preventing a rotation of the first and second wedge portions 40 and 42 when the screws 31 and 33 are rotated. In accordance with the preferred teachings of this invention, the first adjustment screw 31 causes a longitudinal translation of the first wedge portion 40 along said first adjustment screw 31. This translation causes a change in the arc of rotation of both control arms 12 and 14 during flexion of an associated body part. Also preferred, but not necessarily required, is the feature that the second adjustment screw 33 cause a longitudinal translation of the second wedge portion 42 along the second adjustment screw 33 to cause a change in the arc of rotation of both control arms 12 and 14 during extension of the body part. Referring now to FIG. 6, a novel flexion-extension gauge is provided. In the preferred embodiment, the housing 10 comprises an aperture or calibration window 78 for observing a position within said housing for said wedge portions 40 and 42. The wedge portions can be provided with indicator means, shown as black lines 71 and 73 for providing an indication of the longitudinal translation of said wedge portions 40 and 42 within said housing 10. In the most preferred embodiment, the housing comprises scale means 70 which in conjunction with the indicator means 71 and 73 provides a reading indicative of an adjusted arc of rotation for both control arms 12 and 14 during flexion and extension of the associated body part. In the most preferred embodiment of this invention, the first and second adjustment screws 31 and 33 have hexagonal heads adapted for an allen wrench. The invention is used by first inserting a supplied allen wrench into the first adjustment screw 31, corresponding to the "flexion control" of the device. The first adjustment 31 screw should be turned counter-clockwise until it stops. This process should be repeated with the second adjustment screw 33 corresponding to the "extension block" of the device. This setting will allow the hinge 100 to move unrestricted through about a preferred 120° range of motion. To block extension, the supplied allen wrench, in the most preferred embodiment, is inserted into the second adjustment screw 33 and turned clockwise until the preferred black line marking, 71 on wedge portion 40 is observed through aperture or window 78 to align with a desired degree of setting on the scale means 70. To set inflexion, the supplied allen wrench is inserted into the second adjustment screw 33 and turned clockwise until the preferred black line, corresponding to marking 73 on wedge portion 42, aligns with a desired degree of setting on said scale means 70. Similarly, by turning the appropriate adjustment screw counter-clockwise the settings for flexion or extension can be reduced until a new desired setting is achieved. To lock the hinge 100 in a fixed position, a desired degree of extension block must be set, as described above. Then the first adjustment screw 31 corresponding to flexion control, is turned clockwise until it stops. One must not over-tighten the screws 31 and 33 once the hinge 100 has been locked, in order to avoid damaging the hinge 100. The hinge 100 can be unlocked by simply turning the first and second adjustment screws 31 and 33 counter-clockwise. From the foregoing it can be realized that this invention provides an improved orthopedic hinge having independently bi-pivotal control arms and greatly facilitated adjustment means. Although various embodiments have been illustrated, this was for the purpose of describing but not limiting the invention. Various modifications, which will become apparent to one skilled in the art, are within the scope of this invention described in the attached claims.

1a

[0001] This application is a continuation-in-part of U.S. Ser. No. 10/189,992, filed Jul. 5, 2002, which is a continuation-in-part of U.S. Ser. No. 10/090,675, filed Mar. 5, 2002, which are both incorporated by reference herein in their entireties. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates broadly to ophthalmic implants. More particularly, this invention relates to intraocular lenses which are focusable and allow for accommodation for near vision. [0004] 2. State of the Art [0005] Referring to FIG. 1, the human eye 10 generally comprises a cornea 12 , an iris 14 , a ciliary body (muscle) 16 , a capsular bag 18 having an anterior wall 20 and a posterior wall 22 , and a natural crystalline lens 24 contained with the walls of the capsular bag. The capsular bag 18 is connected to the ciliary body 16 by means of a plurality of zonules 26 which are strands or fibers. The ciliary body 16 surrounds the capsular bag 18 and lens 24 , defining an open space, the diameter of which depends upon the state (relaxed or contracted) of the ciliary body 16 . [0006] When the ciliary body 16 relaxes, the diameter of the opening increases, and the zonules 26 are pulled taut and exert a tensile force on the anterior and posterior walls 20 , 22 of the capsular bag 18 , tending to flatten it. As a consequence, the lens 24 is also flattened, thereby undergoing a decrease in focusing power. This is the condition for normal distance viewing. Thus, the emmetropic human eye is naturally focused on distant objects. [0007] Through a process termed accommodation, the human eye can increase its focusing power and bring into focus objects at near. Accommodation is enabled by a change in shape of the lens 24 . More particularly, when the ciliary body 16 contracts, the diameter of the opening is decreased thereby causing a compensatory relaxation of the zonules 26 . This in turn removes or decreases the tension on the capsular bag 18 , and allows the lens 24 to assume a more rounded or spherical shape. This rounded shape increases the focal power of the lens such that the lens focuses on objects at near. [0008] As such, the process of accommodation is made more efficient by the interplay between stresses in the ciliary body and the lens. When the ciliary body relaxes and reduces its internal stress, there is a compensatory transfer of this stress into the body of the lens, which is then stretched away from its globular relaxed state into a more stressed elongated conformation for distance viewing. The opposite happens as accommodation occurs for near vision, where the stress is transferred from the elongated lens into the contracted ciliary body. [0009] In this sense, referring to FIG. 2, there is conservation of potential energy (as measured by the stress or level of excitation) between the ciliary body and the crystalline lens from the point of complete ciliary body relaxation for distance vision through a continuum of states leading to full accommodation of the lens. [0010] As humans age, there is a general loss of ability to accommodate, termed “presbyopia”, which eventually leaves the eye unable to focus on near objects. In addition, when cataract surgery is performed and the natural crystalline lens is replaced by an artificial intraocular lens, there is generally a complete loss of the ability to accommodate. This occurs because the active muscular process of accommodation involving the ciliary body is not translated into a change in focusing power of the implanted artificial intraocular lens. [0011] There have been numerous attempts to achieve at least some useful degree of accommodation with an implanted intraocular lens which, for various reasons, fall short of being satisfactory. In U.S. Pat. No. 4,666,446 to Koziol et al., there is shown an intraocular lens having a complex shape for achieving a bi-focal result. The lens is held in place within the eye by haptics which are attached to the ciliary body. However, the implant requires the patient to wear spectacles for proper functioning. Another device shown in U.S. Pat. No. 4,944,082 to Richards et al., also utilizes a lens having regions of different focus, or a pair of compound lenses, which are held in place by haptics attached to the ciliary body. In this arrangement, contraction and relaxation of the ciliary muscle causes the haptics to move the lens or lenses, thereby altering the effective focal length. There are numerous other patented arrangements which utilize haptics connected to the ciliary body, or are otherwise coupled thereto, such as are shown in U.S. Pat. No. 4,932,966 to Christie et al., U.S. Pat. No. 4,888,012 to Horne et al. and U.S. Pat. No. 4,892,543 to Turley, and rely upon the ciliary muscle to achieve the desired alteration in lens focus. [0012] In any arrangement that is connected to the ciliary body, by haptic connection or otherwise, extensive erosion, scarring, and distortion of the ciliary body usually results. Such scarring and distortion leads to a disruption of the local architecture of the ciliary body and thus causes failure of the small forces to be transmitted to the intraocular lens. Thus, for a successful long-term implant, connection and fixation to the ciliary body is to be avoided if at all possible. [0013] In U.S. Pat. No. 4,842,601 to Smith, there is shown an accommodating intraocular lens that is implanted into and floats within the capsular bag. The lens comprises front and rear flexible walls joined at their edges, which bear against the anterior and posterior inner surfaces of the capsular bag. Thus, when the zonules exert a tensional pull on the circumference of the capsular bag, the bag, and hence the intraocular lens, is flattened, thereby changing the effective power of refraction of the lens. The implantation procedure requires that the capsular bag be intact and undamaged and that the lens itself be dimensioned to remain in place within the bag without attachment thereto. Additionally, the lens must be assembled within the capsular bag and biasing means for imparting an initial shape to the lens must be activated within the capsular bag. Such an implantation is technically quite difficult and risks damaging the capsular bag, inasmuch as most of the operations involved take place with tools which invade the bag. In addition, the Smith arrangement relies upon pressure from the anterior and posterior walls of the capsular bag to deform the lens, which requires that the lens be extremely resilient and deformable. However, the more resilient and soft the lens elements, the more difficult assembly within the capsular bag becomes. Furthermore, fibrosis and stiffening of the capsular remnants following cataract surgery may make this approach problematic. [0014] U.S. Pat. No. 6,197,059 to Cumming and U.S. Pat. No. 6,231,603 to Lang each disclose an intraocular lens design where the configuration of a hinged lens support ostensibly allows the intraocular lens to change axial position in response to accommodation and thus change effective optical power. U.S. Pat. No. 6,299,641 to Woods describes another intraocular lens that also increases effective focusing power as a result of a change in axial position during accommodation. In each of these intraocular lenses, a shift in axial position and an increase in distance from the retina results in a relative increase in focusing power. All lenses that depend upon a shift in the axial position of the lens to achieve some degree of accommodation are limited by the amount of excursion possible during accommodation. [0015] U.S. Pat. No. 5,607,472 to Thompson describes a dual-lens design. Prior to implantation, the lens is stressed into a non-accommodative state with a gel forced into a circumferential expansion channel about the lens. At implantation, the surgeon must create a substantially perfectly round capsullorrhexis, and insert the lens therethrough. A ledge adjacent to the anterior flexible lens is then bonded 360° around (at the opening of the capsulorrhexis) by the surgeon to the anterior capsule to secure the lens in place. This approach has numerous drawbacks, a few of which follow. First, several aspects of the procedure are substantially difficult and not within the technical skill level of many eye surgeons. For example, creation of the desired round capsullorrhexis within the stated tolerance required is particularly difficult. Second, the bonding “ledge” may disrupt the optical image produced by the adjacent optic. Third, intraocular bonding requires a high degree of skill, and may fail if the capsullorrhexis is not 360° round. Fourth, the proposed method invites cautionary speculation as to the result should the glue fail to hold the lens in position in entirety or over a sectional region. Fifth, it is well known that after lens implantation surgery the capsular bag, upon healing, shrinks. Such shrinking can distort a lens glued to the bag in a pre-shrunk state, especially since the lens is permanently affixed to a structure which is not yet in equilibrium. Sixth, Thompson fails to provide a teaching as to how or when to release the gel from the expansion channel; i.e., remove the stress from the lens. If the gel is not removed, the lens will not accommodate. If the gel is removed during the procedure, the lens is only in a flattened non-accommodating shape during adhesion to the capsule, but not post-operatively, and it is believed that the lens therefore will fail to interact with the ciliary body as required to provide the desired accommodation as the capsular bag may change shape in the post-operative period. If the gel is otherwise removed thereafter, Thompson ostensibly requires an additional surgical procedure therefor. In view of these problems, it is doubtful that the lens system disclosed by Thompson can be successfully employed. [0016] Thus, the prior art discloses numerous concepts for accommodating intraocular lenses. However, none are capable of providing an accommodating implant which does not, in one way or another, risk damage to the ciliary body or the capsular bag, present technical barriers, or present potential serious consequences upon failure of the device. SUMMARY OF THE INVENTION [0017] It is therefore an object of the invention to provide an intraocular lens that functions similarly to the natural crystalline lens. [0018] It is another object of the invention to provide an intraocular lens that changes shape and increases power during accommodation. [0019] It is also an object of the invention to provide an intraocular lens that produces a sufficient increase in focusing power such that it is clinically useful. [0020] It is an additional object of the invention to provide an intraocular lens that permits uncomplicated implantation of the lens in a manner compatible with modern-day cataract surgery techniques. [0021] In accord with these objects, which will be discussed in detail below, an intraocular lens (IOL) system that permits accommodation and a method of implanting such an intraocular lens system are provided. Generally, the invention includes an intraocular lens that is maintained in a stressed non-accommodating configuration during implantation into the capsular bag of the eye and maintained in the stressed configuration during a post-operative healing period during which the capsular bag heals about the lens. After the post-operative healing period, the intraocular lens is preferably atraumatically released from the stressed state and permitted to move between accommodative and non-accommodative configurations in accord with stresses placed thereon by the ciliary body and other physiological forces. [0022] According to one embodiment of the invention, the intraocular lens system includes a flexible optic having a skirt (periphery or haptic), and a restraining element about the skirt and adapted to temporarily maintain the flexible optic in a stressed, non-accommodating configuration during a post-operative period. The retraining element may comprise a dissolvable bioabsorbable material such that the element automatically releases the optic after a post-operative period, or may be released under the control of a eye surgeon, preferably via a non-surgically invasive means such as via a laser or a chemical agent added to the eye. [0023] According to another embodiment of the invention, the intraocular lens system includes an optic, a pair of haptics located on sides of the optic, and hinge portions at each of the optic haptic junctions. The hinge portions have stressed and non-stressed state configurations. In accord with the invention, one or more restraining elements are provided to maintain the stressed state configuration of the hinge portion during implantation and during a post-operative period. [0024] Generally, the method includes (a) inducing cycloplegia; (b) providing an intraocular lens having an optic portion and haptics and having an as manufactured bias induced between the optic portion and haptics, the intraocular lens being held in a non-accommodating stressed state by a restraining means such that the intraocular lens has a lower optical power relative to an accommodating non-stressed state of the lens; (c) inserting the stressed state intraocular lens into a capsular bag of the eye; (d) maintaining cycloplegia until the capsular bag physiologically affixes to the intraocular lens; and (e) non-surgically invasively releasing the restraining means to permit the intraocular lens to move from the stressed state into the non-stressed state in which the intraocular lens has an increased optical power, and wherein the optical power of the intraocular lens is reversibly adjustable in response to stresses induced by the eye such that the lens can accommodate. [0025] More particularly, according to a preferred method of implantation, the ciliary body muscle is pharmacologically induced into a relaxed stated (cycloplegia), a capsulorrhexis is performed on the lens capsule, and the natural lens is removed from the capsule. The prosthetic lens is then placed within the lens capsule. According to a preferred aspect of the invention, the ciliary body is maintained in the relaxed state for the duration of the time required for the capsule to naturally heal and shrink about the lens; i.e., possibly for several weeks. After healing has occurred, the restraining element automatically or under surgeon control releases the lens from the stressed state. The ciliary body and lens may then interact in a manner substantially similar to the physiological interaction between the ciliary body and a healthy natural crystalline lens. [0026] Alternatively, a fully relaxed lens (i.e., without restraining element) can be coupled to a fully stressed and contracted ciliary body. [0027] The intraocular lens system of the invention is compatible with modern cataract surgery techniques and allows for large increases in optical power of the implanted lens. Unlike other proposed accommodating intraocular lens systems, the lens described herein is capable of higher levels of accommodation and better mimics the function of the lens of the human eye. Further, unlike other lens systems previously described, the lens take into account certain reciprocal aspects of the relationship between the natural crystalline lens and the ciliary body. Moreover, the implantation is relatively easy and rapid. [0028] Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures. BRIEF DESCRIPTION OF THE DRAWINGS [0029] [0029]FIG. 1 is a diagrammatic view of a cross-section of a normal eye; [0030] [0030]FIG. 2 is a graph of the stresses on the ciliary body-crystalline lens system of the eye in a continuum of states between distance vision and full accommodation; [0031] [0031]FIG. 3 is a schematic front view of an intraocular lens according to the invention configured into a stressed state with a restraining element; [0032] [0032]FIG. 4 is a schematic transverse section view of the intraocular lens of FIG. 3 in a stressed state; [0033] [0033]FIG. 5 is a schematic transverse section view of the intraocular lens of FIG. 3 in a non-stressed accommodating state; [0034] [0034]FIGS. 6 and 7 are other schematic transverse section views of intraocular lenses according to the invention; [0035] [0035]FIG. 8 is a schematic front view of an intraocular lens according to the invention with the restraining element removed, and thus, configured in a non-stressed accommodating state; [0036] [0036]FIG. 9 is a transparent front view of an intraocular lens according to the invention shown with a second embodiment of a restraining element; [0037] [0037]FIG. 10 is a schematic transverse view of the intraocular lens of FIG. 9; [0038] [0038]FIG. 11 is a transparent front view of an intraocular lens according to the invention shown with a third embodiment of a restraining element; [0039] [0039]FIG. 12 is a schematic transverse view of the intraocular lens of FIG. 11; [0040] [0040]FIG. 13 is a transparent front view of an intraocular lens according to the invention shown with a fourth embodiment of a restraining element; [0041] [0041]FIG. 14 is a schematic transverse view of the intraocular lens of FIG. 13; [0042] [0042]FIG. 15 is a schematic front view of an intraocular lens according to the invention having a particular skirt configuration which include haptics and another alternate embodiment restraining element; [0043] [0043]FIG. 16 is a schematic front view of another intraocular lens according to the invention having a particular skirt configuration which include haptics and yet another alternate embodiment restraining element; [0044] [0044]FIG. 17 is a schematic side view of the intraocular lens of FIG. 16; [0045] [0045]FIG. 18 is an intraocular lens according to the invention having a particular skirt configuration which include haptics and yet a further alternate embodiment restraining element; [0046] [0046]FIG. 19 is a block diagram of a first embodiment of a method of implanting an intraocular lens according to the invention; [0047] [0047]FIG. 20 is a block diagram of a second embodiment of a method of implanting an intraocular lens according to the invention; [0048] [0048]FIG. 21 is a block diagram of a third embodiment of a method of implanting an intraocular lens according to the invention; [0049] [0049]FIG. 22 is a schematic front view of a second embodiment of an intraocular lens according to the invention, shown in a stressed configuration; [0050] [0050]FIG. 23 is a schematic side view of the intraocular lens of FIG. 22, shown in a stressed configuration; [0051] [0051]FIG. 24 is a schematic side view of the intraocular lens of FIG. 22, shown in a non-stressed configuration; [0052] [0052]FIG. 25 is a schematic side view of the intraocular lens according to the second embodiment of the invention held in a stressed configuration with a bridge-type restraining element; [0053] [0053]FIG. 26 is a schematic side view of the intraocular lens of FIG. 25 shown in a non-stressed configuration; [0054] [0054]FIG. 27 is a schematic front view of an intraocular lens according to the invention having four haptics; [0055] [0055]FIG. 28 is a diagrammatic view of a cross-section of an eye having an intraocular lens according to the second embodiment of the invention implanted therein, the lens being in a stressed configuration; and [0056] [0056]FIG. 29 is a diagrammatic view of a cross-section of an eye having an intraocular lens according to the second embodiment of the invention implanted therein, the lens being in a non-stressed configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0057] Turning now to FIG. 3, a first preferred embodiment of an intraocular lens 100 according to the invention is shown. The lens includes a pliable optic portion 102 having an elastic memory, and is peripherally surrounded by a skirt portion 104 . A restraining element 106 is provided on the skirt portion 104 and operates to hold the skirt portion and optic portion 102 in a stressed (i.e., stretched) configuration. Comparing FIG. 3, showing the optic portion in a stressed configuration, with FIG. 8, showing the optic portion in a non-stressed configuration, it is seen that the optic portion has a smaller diameter in the non-stressed configuration. [0058] More particularly, the optic portion 102 is typically approximately 5 to 6 mm in diameter and made from a silicone polymer or other suitable flexible polymer. The optic portion defines an anterior surface 110 and a posterior surface 112 . The optic portion may have a biconvex shape in which each of the anterior surface 110 and posterior surface 112 have similar rounded shapes. FIG. 4 illustrates such a lens in a stressed non-accommodating configuration, while FIG. 5 illustrates such a lens in the non-stressed accommodating configuration. Alternatively, referring to FIG. 6, the anterior surface 110 a may be provided with a substantially greater curvature than the posterior surface 112 a . In addition, referring to FIG. 7, the anterior and posterior surfaces 110 , 112 of the optic portion can be evenly pliable throughout, or, referring back to FIG. 6, greater flexibility and pliability can be fashioned into the central portion 114 of the anterior 110 surface of the lens to enhance the accommodating effect. This may be done by using materials of differing modulus of elasticity or by altering the thickness of the central portion and/or anterior surface 110 of the optic portion 102 . [0059] Referring back to FIG. 3, the skirt portion 104 has substantially less pliability than the optic portion 102 . The periphery 116 of the skirt portion 104 is preferably provided with a plurality of circumferentially displaced fenestration holes 118 . The fenestration holes 118 operate to promote firm attachment of the capsular bag to the lens skirt 104 during the healing period. That is, during the healing process, the capsular bag shrinks by a substantial amount and portions of the anterior and posterior capsular bag enter into the fenestration holes 118 and join together to lock the lens 100 within the capsule without necessitating any bonding agent, sutures, or the like. Alternatively, the peripheral portion 104 could be fashioned with a textured surface, ridges or any surface modification that promotes strong adhesion of the capsule to the lens skirt 104 . [0060] Referring to FIGS. 3 and 4, according to a preferred, though not essential, aspect of the invention, a preferably thin and pliable collar 120 is positioned around the anterior surface of lens near the junction 122 (FIG. 8) of the optic portion 102 and the skirt portion 104 to keep the more central portions of the anterior capsular remnant from adhering to the optic portion. The collar is preferably made from silicone or another smooth polymer. [0061] As discussed above, the skirt portion 104 is maintained in a stressed configuration by the restraining element until the restraining element is removed. According to a preferred embodiment of the restraining element, the restraining element is a band provided on the outside of the skirt portion. The band 106 is preferably comprised of a dissolvable, preferably bioasborbable material that is adapted to preferably naturally dissolve in the fluid of the eye within a predetermined period of time after implantation. Alternatively, the dissolvable material may be selected so that it dissolves only upon the addition of a dissolving-promoting agent into the eye. Preferred dissolvable materials for the restraining band 106 include collagen, natural gut materials, glycan, polyglactin, poliglecaprone, polydioxanone, or other carbohydrate-based or protein-based absorbable material. [0062] Referring now to FIGS. 9 and 10, according to a second embodiment of the restraining element 106 a , the restraining element comprises a circumferential channel 130 a in the skirt 104 that is filled with a fluid or gel 132 a . Preferably an isotonic solution such as a balanced salt solution is used. Alternatively, other suitable fluids, solution, or gels, including viscoelastics can be used. The channel 130 a has an outlet 134 a that is blocked by a dissolvable, preferably bioabsorbable seal 136 a . The filled channel 130 a operates to stress the optic portion 102 into a non-accommodating configuration until the seal 136 a is dissolved and the outlet 134 a is thereby opened. Then, the material 132 a within the channel 130 a is forced out of the channel by the natural elasticity of the lens and permits the lens to move in accord with the excitation state of the ciliary body; i.e., between non-accommodative and accommodative states. Alternatively, the seal material 136 a may not be naturally dissolvable within the environment of the eye, but rather is dissolvable within the presence of a chemical agent, such as an enzyme, which can be added to the eye. In such case, the eye surgeon can non-surgically control the release of the seal. [0063] Turning now to FIGS. 11 and 12, according to a third embodiment of the restraining element, the restraining element 106 b comprises a circumferential channel 130 b in the skirt portion 104 that is filled with a balanced salt solution or other suitable material 132 b that maintains the optic portion into a non-accommodating stressed configuration. The channel 130 b has an outlet tube 134 b that is biased outward from the optic portion 108 but which is preferably anchored with an anchor 135 b toward the optic portion 102 but which preferably does not overlie a central area of the optic portion which would interrupt the vision of the patient when the lens is implanted. The outlet tube 134 b is provided with a seal 136 b made from a material, e.g., hard silicone, polymethylmethacrylate (PMMA) or plastic, that is ablatable or otherwise able to be unsealed by laser light from a YAG laser or other laser suitable for eye surgery. Likewise, the anchor 135 b is also made from such a material. When the lens is implanted, as discussed in detail below, the anchor 135 b and the outlet tube 134 b , by being directed toward the optic portion 102 , is visible to the eye surgeon through a dilated iris and is positioned to receive laser light. In this embodiment, the seal 136 b can be removed and the outlet tube 134 b opened under the full control of the eye surgeon (at his or her discretion upon post-operative evaluation of the lens recipient) by use of a laser to remove the pressure in the channel 130 b to equilibrate with the anterior chamber pressure of the eye. Moreover, removal of the anchor 135 b enables the outlet tube to move away from the optic portion in accord with its bias and toward the periphery to minimize any potential interference with the patient's vision. [0064] According to a fourth embodiment of the restraining element, any mechanical means for maintaining the lens in a stressed configuration can be used. For example, referring to FIGS. 13 and 14, a relatively stiff restraining element 132 c having a circular form can be inserted or otherwise provided within a circumferential channel 130 c . The restraining element is made from a material designed to be ablated or broken upon receiving laser energy, e.g., hard silicone, polymethylmethacrylate (PMMA) or plastic. Alternatively, the end of the element 132 c can be provided with a length of flexible material 134 c , e.g., suture, which can be extended to outside the eye. When it is desired to remove the restraining element, the surgeon grasps the suture with a forceps and pulls the suture. This either removes the restraining element from the lens or breaks the restraining element. In either case, the stress is released from the optic. As yet another less preferred alternative, stiff restraining element is removable or broken only upon an invasive (requiring an incision) surgical procedure. [0065] Other embodiments for the restraining elements and removal thereof are possible. For example, and not by way of limitation, the seal for an inflated channel can be attached to a suture or other length of flexible material which extends outside the eye. The suture can be pulled by the surgeon to remove the seal. In yet another example, shallow shells, adapted to be dissolvable naturally or in conjunction with an additive agent, may be provided to the front and back of the optic portion to force the optic portion to adopt a flatter (i.e., stressed) configuration. By way of another example, dissolvable or laser-removable arced struts may be provided across the lens which force the optic portion into a stressed state. [0066] Moreover, embodiments of the restraining element which maintain the stressed state of the optic via external flattening of the optic or by arced struts are suitable for use with a non-circumferential skirt portion; i.e., where the skirt portion is defined by a plurality of haptics extending outward from the optic portion. For example, FIGS. 15-18, illustrate the “skirt portion” defined by a plurality of haptics, rather than a complete ring about the optic. FIG. 15 discloses a skirt portion 104 a a defined by three haptics 140 a , each of which preferably includes fenestration holes 118 a . Dissolvable or laser-ablatable arced struts 142 a are situated to maintain a radial stress on the optic portion 102 a ; i.e., the struts 142 a function together as a restraining member. FIGS. 16 and 17 discloses a skirt defined by four haptics 140 b , each of which preferably includes fenestration holes 118 b . Shells 144 b are coupled to the haptics anterior and posterior of the optic to flatten the optic. FIG. 18 discloses a skirt defined by two haptics 140 c , each of which preferably includes fenestration holes 118 c . Multiple struts 142 c are coupled to each haptic 140 c. [0067] In addition, it is recognized that the optic portion may be provided in an optically transparent bag, and the bag may be pulled or otherwise forced taught to stress the optic. The bag may be pulled taught by using one of the restraining element described above, e.g., retaining rings, channels, shells, or struts, or any other suitable means, provided either directly to the bag or provided to an element coupled about a periphery of the bag. [0068] Moreover, it is recognized that the lens of the invention may comprise two optic elements: one stationary and the other adapted to change shape and thereby alter the optic power of the dual optic system. In such an embodiment, the optic element adapted to change shape would be provided in a stressed-configuration, according to any embodiment described above. [0069] In each embodiment of the restraining element, the restraining element is preferably configured on or in the lens during manufacture, such that the lens is manufactured, shipped, and ready for implant in a fully stressed configuration. [0070] The lens is implanted according to a first method of implantation, as follows. Referring to FIG. 19, the patient is prepared for cataract surgery in the usual way, including full cycloplegia (paralysis of the ciliary body) at 200 . Cycloplegia is preferably pharmacologically induced, e.g., through the use of short-acting anticholinergics such as tropicamide or longer-lasting anticholinergics such as atropine. [0071] An anterior capsullorrhexis is then performed at 202 and the lens material removed. A stressed lens according to the invention is selected that preferably has an optic portion that in a stressed-state has a lens power selected to leave the patient approximately emmetropic after surgery. The lens is inserted into the empty capsular bag at 204 . [0072] Cycloplegia is maintained for several weeks (preferably two to four weeks) or long enough to allow the capsular bag to heal and “shrink-wrap” around the stressed and elongated lens at 206 . This can be accomplished post-operatively through the use of one percent atropine drops twice daily. As the lens shrinks, the anterior and posterior capsular bag walls enter into the fenestration holes and join together to lock the lens in position. [0073] If the lens includes a restraining element having a dissolvable component, eventually the dissolvable material is lost from the lens, and the lens is unrestrained. If the lens includes a restraining element having a laser-removable component, a surgeon may at a desired time remove the component to place the lens in a unrestrained configuration. If the lens includes a retraining element which must be surgical removed or altered, the surgeon may at a desired time perform a second eye procedure to remove the component and place the lens in an unrestrained configuration. [0074] Regardless of the method used, when the lens is unrestrained (i.e., released from the stressed state) at 208 and the post-operative cycloplegic medicines are stopped at 210 the lens is initially still maintained in a stressed state (FIG. 4) due to the inherent zonular stress of the non-accommodating eye. When the patient begins accommodating, the zonular stress is reduced and the implanted lens is permitted to reach a more relaxed globular conformation, as shown in FIGS. 5 and 8. This change in shape provides the optic with more focusing power and thus accommodation for the patient is enabled. As with the natural crystalline lens, the relaxation of the implanted lens to a more globular shape is coupled with a development of strain or stress in the ciliary body during accommodation. Further, when the patient relaxes accommodation, the stress in the ciliary body is reduced, and there is a compensatory gain in stress as the lens is stretched into its non-accommodative shape (See again FIG. 2). [0075] Referring to FIG. 20, according to another embodiment of the method of the invention, a lens of similar design as described above is used, except that there is no restraining element on the lens. Temporary cycloplegia is induced, and a capsulorrhexis is performed 300 . The lens is implanted while the ciliary body is in a fully relaxed state at 302 . The patient is then fully accommodated (i.e., the ciliary body is placed in a contracted state) at 304 , preferably through pharmacological agents such as pilocarpine. [0076] Once the capsular bag is fully annealed (affixed) to the lens periphery at 306 , the pharmacological agent promoting accommodation is stopped at 308 . Then, as the ciliary body relaxes, the lens is stretched into an elongated shape having less focusing power. Conversely, as accommodation recurs, the lens returns to it resting shape having greater focusing power. [0077] Referring to FIG. 21, in yet another embodiment of the method of the invention, the patient is cyclopleged during cataract surgery at 400 , a capsulorrhexis is performed at 402 , and a flexible lens in an unstressed state is implanted in the capsular bag at 404 . After a few weeks of complete cycloplegia and during which capsular fixation of the lens periphery is accomplished at 406 , light (e.g., ultraviolet or infrared), a chemical agent, or another suitable means is used to shrink or otherwise alter the optic or the adjacent skirt of the lens while the patient is still fully cyclopleged at 408 . In this manner, the optic is again placed into a stressed configuration while the ciliary body is fully relaxed. As with previous embodiments, when cycloplegia is stopped and accommodation occurs at 410 , the lens is able to return to a more relaxed globular configuration. [0078] The intraocular lens systems described with respect to FIGS. 1 through 18 operate to provide accommodation through a change in shape in the optic resulting from an equilibrium of the anatomical forces and the forces in the lens. As now described, it is also possible to provide accommodation through axial movement of a lens within the eye, all while maintaining equilibrium between the anatomical forces and the structural stress designed into the lens. [0079] Turning now to FIG. 22 through 24 , an embodiment of another intraocular lens system according to the invention is shown. The lens 500 includes a central optic 502 , two peripheral haptics 504 , and a junction 506 between the optic 502 and the haptics 504 . The junction 506 preferably has an elastic memory such that, in a relaxed configuration of the lens 500 , free ends 505 of the haptics 504 are oriented at a posterior angle a relative to the optic 502 (FIG. 24); i.e., there is a bias induced between the optic and haptics along an anterior-posterior axis. A preferred range for angle a includes 1 to 60 degrees, with a more preferred angle a being 25 to 35 degrees. The junction 506 can be a skirt portion attached about the periphery of the optic, or can be integrated into the periphery of the optic, particularly where the optic and junction are unitarily formed as one piece from a flexible polymeric material. In addition, the junction 506 can vary in size allowing elastic bias over part or all of the haptic. For instance, the unstressed conformation of the haptic can describe an arc over all or part of its length. A restraining element 508 is preferably provided either at the junction 506 to restrain flexing at the junction (FIGS. 22) or extends as a bridge from the optic 502 to the haptics 504 (FIG. 25) to maintain the lens 500 in a stressed preferably substantially planar configuration during implantation and for a post-operative period. Alternatively, the stressed configuration can be any configuration of the lens in which the optic is oriented in a more posterior orientation relative to the haptic than in the non-stressed configuration. When the restraining element 508 is removed, the haptics 504 are biased toward an angled configuration relative to the optic 502 , with the optic moved anteriorly relative to the haptics (FIG. 26). [0080] More particularly, the optic 502 can be a flexible construction, as in the previous embodiments, or may be substantially rigid. The optic is preferably fixed in power, but may contain zones of different optic power. As such, the optic is either constructed of a suitable flexible polymer such as a silicone polymer, or a suitable stiff plastic such as polymethylmethacrylate (PMMA). The optic preferably has a diameter of approximately 4 mm to 7 mm, and most preferably approximately 5 mm. [0081] The haptics 504 can be substantially planar, curved or loop-like in structure; i.e., they may generally conform to any well-known haptic structure. Moreover, as shown in FIG. 27, there may be more than two haptics, e.g., four haptics 504 a . Furthermore, as described with respect to the previous embodiments, the haptics 504 may be provided with any number of surface modifications, including knobs, protuberances, textures, fenestration holes, ridge, etc., that promote strong adhesion with the shrink-wrapped capsular remnant. For example, referring back to FIGS. 25 and 26, a peripheral ridge 510 may be provided to the haptics 504 . The ridge 510 promotes adhesion as well as forces the lens into a more posterior portion of the capsular bag upon implantation, which may be desirable. In addition, the haptics may contain portions of varying flexibility, such as a more flexible peripheral extent to promote flexion of the peripheral haptic against the capsular rim. [0082] The restraining elements 508 , as described with respect to the earlier embodiments, are preferably bio-resorbable, chemically resorbable, laser-removable, or surgically removable. Any restraining element that is removable in the one of the above listed manners or in any other relatively atraumatic manner and which provides the necessary function of maintaining the lens in a relatively planar stressed configuration during implantation and during a post-operative period can be similarly used. [0083] The lens 500 is implanted as described above. That is, cycloplegia is induced, an anterior capsullorrhexis is performed and the lens material removed. Referring to FIG. 28, the lens, in a stressed, substantially planar configuration is inserted into the empty capsular bag. Cycloplegia is maintained long enough to allow the capsular bag to heal, “shrink-wrap”, and fibrose around the stressed lens. After the bag has healed, cycloplegia is terminated and the restraining element (not shown in FIG. 28) is removed. [0084] Referring to FIG. 29, with the lens unrestrained, the optic 502 of the lens 500 is able to move anteriorly forward during accommodation and increase the focusing power of the eye. The optic 502 moves forward for at least two reasons. First, with accommodation, the stress in the ciliary body 16 is increased causing constriction of the ciliary body, and resultant reduced tension on the zonules 26 . This allows bending of the haptic-optic junction 506 back to its relaxed non-planar configuration. Second, during accommodation there is anterior movement of the ciliary body 16 . [0085] Then, when the patient relaxes accommodation, the stress in the ciliary body 16 is reduced and the ciliary body dilates and moves posteriorly. There is a compensatory gain in stress across the optic-haptic junction 506 as the junction is bent against its memory into a more planar configuration and the optic 502 moves posteriorly (See again FIG. 28). [0086] In addition, as discussed above with respect to the first embodiment, a photoreactive intraocular lens may be implanted in an unstressed state. After capsular fixation of the lens, light (e.g., ultraviolet or infrared), a chemical agent, or another suitable means is used to alter the optic into a stressed configuration while the ciliary body is fully relaxed. Then, when cycloplegia is stopped and accommodation occurs, the lens is able to return to non-stressed configuration in which the lens is located anteriorly relative to the haptic portion. [0087] Moreover, as also discussed above with respect to the first embodiment, the lens can be implanted in the eye in a non-stressed configuration, and the ciliary can be pharmacologically induced to contract during the healing period. After healing, pharmacological inducement of ciliary contraction is stopped, and the lens operates in the same manner as described above. [0088] There have been described and illustrated herein several embodiments of an intraocular lens and methods of implanting the same into an eye. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while two particular states of intraocular lenses (fully stressed and fully accommodating) have been disclosed, it will be appreciated that there is a continuum of states of stress that can be fashioned in the inserted lens that would be appropriate for any given state of the ciliary body. In addition, while particular types of materials have been disclosed for the lens, the dissolving material, and a viscoelastic material (where used), it will be understood that other suitable materials can be used. Also, while exemplar pharmacological agents are disclosed for maintaining a state of the ciliary body, it is understood that other agents can be used. Furthermore, while the skirt has been shown comprised of two to four haptics, it is recognized that a single haptic or five or more haptics may be utilized. Moreover, while the restraining struts and shells have been described with respect to skirts comprising haptics, it will be appreciated that the restraining struts and shells can be used with a circular skirt, as described with respect to the preferred embodiments. In addition, while in the second embodiment the optic-haptic junction is stated to preferably have a memory, it is appreciated that other means may be employed to cause the haptics to assume a non-stressed angle configuration relative to optic. For example, an elastic membrane or struts may connect the free ends of the haptics to urge the free ends toward each other and consequently the optic forward. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

1a

PRIORITY CLAIM The present application claims benefit under 35 USC Section 119(e) of U.S. Provisional Patent Application Ser. No. 60/976,423 filed on 29 Sep. 2007 and of U.S. Provisional Patent Application Ser. No. 60/976,425 filed on 29 Sep. 2007. The present application is based on and claims priority from these applications, the disclosures of which are hereby expressly incorporated herein by reference. BACKGROUND The present invention relates to devices, systems, and treatment methods directed at aligning and correcting orthodontic or dentofacial abnormalities, including both foundational correction (a treatment that changes the skeletal and/or dental tissues) and functional correction (a treatment that changes the soft tissues and/or tissue spaces). More specifically, the present invention relates to devices, systems, and methods incorporating osteogenetic-orthodontic appliances. Osteogenetic-orthodontic appliances are specialized orthopedic and/or orthodontic appliances that signal the genome of the patient to remodel tissues and spaces. In contrast, the prior art teaches that common orthodontic and dentofacial abnormalities are suitably corrected by using treatment methods and devices that apply continuous forces via brackets and wires (which translate to vectors that apply force to teeth). Traditional orthodontic or dentofacial treatments that address orthopedic correction are known as Phase I treatments and are characterized, typically, as using bio-mechanical systems. Examples known in the art include Twin Block appliances. After Phase I treatments for orthopedic correction, using brackets bonded to teeth, Phase II is undertaken: Correcting, leveling, aligning, and rotation of the teeth is undertaken using wires of various shapes and sizes. The present invention, along with traditional methods and devices, attempts to correct common orthodontic and craniofacial abnormalities, which are undesired for both esthetic and medical reasons. For example, in the craniofacial region, a well-balanced face is not only perceived as beautiful, but it is also free of health problems such as: dental malocclusions and tooth wear; facial underdevelopment (including facial asymmetry and craniofacial obesity); temporo-mandibular joint dysfunction (TMD), and upper airway difficulties, such as snoring, sleep disordered breathing, and obstructive sleep apnea (OSA). These conditions, whether diagnosed or covert, represent major issues in this field of work. For example, traditional devices and treatments do not adequately address the underlying causes of poor tooth alignment. Poor tooth alignment is commonly accompanied by several other clinically-observable signs and symptoms, such as facial asymmetry, according to the patient's genome. One major issue not adequately addressed in the prior art teachings and traditional methods and devices is the irregular alignment of teeth as a result of development compensation. For example, malocclusion, an obvious sign of which is irregular teeth, belies a more serious issue, and may require correction and/or development of the bone constituting the jaws during comprehensive orthodontic care. The current art does not fully treat the underlying cause by adequately interacting with or naturally-manipulating the genome because the traditional methods and devices do not recognize the importance of the gene-environmental interactions and, therefore, lack the structural elements necessary to properly signal the genes, which results in less than optimal corrections despite the temporo-spatial pattern or genetic template of facial development. Examples of common but detrimental environmental stimuli include myofunctional influences, such as bottle-feeding, a lack of breast-feeding, pacifier use, thumb-sucking, and other childhood habits including a soft diet of refined foods. Thus, dysfunctional features—such as adverse tongue posture, abnormal swallowing patterns, and lip activity—lead to further craniofacial consequences as the child matures (such as malocclusion). Yet, some of these consequences (such as obstructive sleep apnea) may not manifest until adulthood. These consequences are the outcomes of gene-environmental factors that are thought to perturb the genetic craniofacial foundation encoded by genes, and include features such as a high-vaulted palate with maloccluded teeth, and functional features, such as a submandibular pannus (double chin). However, the complexity of these gene-environmental interactions leads to heterogeneity in terms of patient presentation. Thus, patients may present with a single feature, such as a malocclusion, TMD, snoring, wear facets on teeth, aged facial appearance, or any combination of the above, even though the underlying etiology is similar. For any foundational correction to remain stable, it must be co-provided with a functional correction. More recently, biomechanical loading is thought to be an important regulator of osteogenesis, as bone formation occurs in response to its functional environment. Based on this information, biophysical techniques of osteo-stimulation have been successfully introduced into clinical practice. These biophysical techniques include craniofacial distraction osteogenesis, and the application of ultrasound etc. to promote bone formation. As well, titanium implants are commonly used in orthopedics and dentistry. These implants integrate into the host's bone by a complex process known as osseo-integration. Data suggest that micromechanical forces may have anabolic effects on bone in-growth surrounding intra-osseous titanium implants. For example, in one study micromechanical forces of 200 mN at 1 Hz were delivered axially to implants for 10 minutes per day for 12 consecutive days. The average bone volume near the mechanically loaded implants was significantly greater than the unloaded control side, and the average number of bone-producing osteoblast-like cells was significantly greater on the loaded side compared to the controls. There was also a significant increase in mineral apposition and bone-formation rate for the mechanically stressed implants compared to the controls. Therefore, modulation of bone in-growth can occur by in vivo micromechanical loading. A considerable part of oral and maxillofacial surgery deals with bone healing. Recently, low-intensity ultrasound treatment has been shown to reduce the healing time of bone fractures. To observe the clinical effects of low intensity ultrasound after tooth extraction in patients, the sockets on one side were treated with low intensity ultrasound while the other side underwent no treatment. It was found that clinical use of low intensity ultrasound reduced post-operative pain and the incidence dry socket, and it also stimulated bone healing after extraction of mandibular third molar teeth. Therefore, the potential of ultrasound to stimulate maxillofacial bone healing may be of value in other orthopedic applications. One study applied ultrasound to human gingival fibroblasts, mandibular osteoblasts, and monocytes. Ultrasound was found to induce cell proliferation in fibroblasts and osteoblasts by 35-50%. Collagen synthesis was also significantly enhanced (up to 110%) using a 45 kHz ultrasound device with intensities of 15 and 30 mW/cm2 (SA). In addition, angiogenesis-related cytokine production, such as IL-8, bFGF and VEGF were also significantly stimulated in osteoblasts. Therefore, therapeutic ultrasound induces in vitro cell proliferation, collagen production, bone formation, and angiogenesis. Another known structure known in the prior art is sutures, which are fibrous connective tissue joints found between intramembranous craniofacial bones. They consist of multiple connective tissue cell lines, such as mesenchymal cells, fibroblasts, osteogenic cells, and osteoclasts. Sutures are organized with osteogenic cells at the periphery, producing a matrix that is mineralized during bone growth and development; with fibroblastic cells with their matrices in the center. Cyclic loading of these sutures may have clinical implications including acting as mechanical stimuli for modulating craniofacial growth and development in patients. One study demonstrated that in vivo mechanical forces regulate sutural growth responses in rats. In that study, cyclic compressive forces of 300 mN at 4 Hz were applied to the maxilla for 20 minutes per day over 5 consecutive days. Computerized analysis revealed that cyclic loading significantly increased the average widths of the sutures studied in comparison with matched controls, and the amount of osteoblast-occupied sutural bone surface was significantly greater in cyclically loaded sutures. These data demonstrate that cyclic forces are potent stimuli for modulating postnatal sutural development, potentially by stimulating both bone formation (osteogenesis) and remodeling (osteoclastogenesis). In a similar study, static and cyclic forces with the same magnitude of 5N were applied to the maxilla in growing rabbits in vivo. Bone strain recordings showed that the waveforms of static force and 1 Hz cyclic force were expressed as corresponding static and cyclic sutural strain patterns. However, on application of repetitive 5N cyclic and static forces in vivo for 10 minutes per day over 12 days, cyclic loading induced significantly greater sutural widths than controls and static loading. Cell counting also revealed significantly more sutural cells on repetitive cyclic loading than sham control and static loading. Fluorescent labeling of newly formed sutural bone demonstrated more osteogenesis on cyclic loading in comparison with sham control and static loading. Thus, the oscillatory component of cyclic force, or more precisely the resulting cyclic strain experienced in sutures, is a potent stimulus for sutural growth. The increased sutural growth by cyclic mechanical strain suggests that both microscale tension and compression induce anabolic sutural growth response. Therefore, mechanical forces readily modulate bone growth, and cyclic forces evoke greater anabolic responses of craniofacial sutures and cartilage. In another study, the premaxillo-maxillary sutures of growing rabbits received in vivo exogenous static forces with peak magnitudes of 2N, or cyclic forces of 2N with frequencies of 0.2 Hz and 1 Hz. The static force and two cyclic forces did not evoke significant differences in the peak magnitude of static bone strain. However, cyclic forces at 0.2 Hz delivered to the premaxillo-maxillary suture for 10 minutes per day over 12 days (120 cycles per day) induced significantly more craniofacial growth, marked sutural separation, and islands of newly formed bone, in comparison with both sham controls and static force of matching peak magnitude. This data demonstrates that application of brief doses of cyclic forces induces sutural osteogenesis more effectively than static forces with matching peak magnitude. Sutural growth is accelerated upon small doses of oscillatory strain (600 cycles delivered 10 minutes per day over 12 days), and both oscillatory tensile and compressive strains induce anabolic sutural responses beyond natural growth. Oscillatory strain likely modulates genes and transcription factors that activate cellular developmental pathways via mechanotransduction pathways. And, sutural growth is determined by hereditary and mechanical signals via gene-environmental interactions or epigenetics. Therefore, small doses of oscillatory mechanical stimuli have the potential to modulate sutural growth for therapeutic objectives. The above data suggest that oro-facial sutures have capacities for mechanical deformation. The elastic properties of sutures are potentially useful for improving our understanding of their roles in facial development. Current data on suture mechanics suggest that mechanical forces regulate sutural growth by inducing sutural mechanical strain. Therefore, various orthopedic therapies, including orthodontic functional appliances, may induce sutural strain, leading to modification of natural sutural growth. Additionally, for example, Singh G. D., Diaz, J., Busquets-Vaello, C., and Belfor, T. R. in “Soft tissue facial changes following treatment with a removable orthodontic appliance in adults,” Funct. Orthod ., (2004) vol. 21 no. 3 at pp. 18-23 reported dental and facial changes in adults treated with a static removable orthodontic appliance (and as disclosed in United States Patent Application No. 2007/0264605 published on 15 Nov. 2007 and as disclosed in U.S. Pat. Nos. 7,314,372 issued on 1 Jan. 2008 and 7,357,635 issued on 15 Apr. 2008, the full disclosures of which are hereby incorporated by reference as if set out fully herein). The maxillary arch showed a 30-percent relative size increase in the mid-palatal region (corresponding to the mid-palatal suture) with shape changes consistent with improved dental alignment and maxillary expansion in the transverse direction. However, the treatment time was excessively long (up to 30 months in one case). Nevertheless, current orthodontic and dentofacial orthopedic therapies exclusively utilize static forces to change the shape of craniofacial bones via mechanically induced bone apposition and resorption, but cyclic forces capable of inducing different sutural strain wave forms may accelerate sutural anabolic or catabolic responses. Recently, it was shown that low intensity pulsed ultrasound enhances jaw growth in primates when combined with a mandibular appliance, and that orthodontically induced root resorption can be repaired using ultrasound in humans. Thus, there remains a need for improved treatment methods, systems, and devices that utilize therapy that harness the underlying developmental mechanisms—encoded at the level of the gene. Further, such improved treatment methods, devices, and systems should utilize the application of brief doses of cyclic forces to induce sutural osteogenesis. Additionally, there remains a need for a removable orthopedic-orthodontic appliance with cyclic functionality and a system and method to bioengineer vibrational orthopedic-orthodontic devices. Further, teeth are adept at adapting to axial stimuli preferentially through physiologic mechanisms. These developmental mechanisms include active tooth eruption, passive tooth eruption; and the tooth support phenomenon. For example, when a deciduous tooth is lost, the permanent successor will typically actively erupt in an axial direction until it makes contact with an opposing tooth or teeth. Similarly, when a tooth is extracted, the opposing tooth can passively erupt until it meets some hindrance. In the tooth support phenomenon, teeth undergo an initial elastic intrusion when an axial force is applied; and a further visco-elastic intrusion if the force is maintained, for example during mastication. When the axial force is removed, the tooth undergoes initial elastic extrusion and further visco-elastic extrusion (recovery) so that the tooth returns to its original position, in balance or in equilibrium with the opposing tooth/teeth. However, when an orthodontic device is applied to a tooth these natural mechanisms of homeostasis can be overpowered. In contrast, during the development of the dentition, commonly referred to as tooth eruption, it is now thought that inherited genes are transcribed and expressed. The timing and orderly eruption of teeth is genetically-encoded in a developmental mechanism that is part of a systemic phenomenon called temporo-spatial patterning. In other words, specific teeth develop at specific sites at specific times. Thus, there is an innate, physiologic mechanism of tooth alignment that can be overpowered by biomechanical orthodontic therapy. Moreover, current research in molecular genetics suggests that external stimuli can cause the expression of genes that are not normally expressed. Therefore, the application of appropriate external stimuli to teeth that have already completed their eruptive phase can cause these teeth to take up new positions in accord with the patient's genome as determined by temporo-spatial patterning, using the patient's own natural genome. Bearing in mind that teeth are adept at adapting to stimuli in the axial direction, the spring design described herein is orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth, unlike all previous designs that contact the palatal/lingual surface of the tooth in the transverse plane. Conventional orthodontic therapy is based on the premise that when a force is applied to a tooth, the tooth will move in response to the force. Thus, conventional fixed orthodontic approaches are primarily based upon the manipulation of teeth by exerting, controlling and maintaining forces, vectors and moments on teeth and/or roots. This torque control can be exerted on teeth either individually, segmentally or by the use of wires that engage the entire dental arch through the use of brackets. In order to apply corrective forces, sophisticated systems of brackets and wires are commonly deployed. Brackets and/or bands of various designs are directly bonded to the surfaces of the teeth. The brackets have slots at various orientations that can engage wires. The wires are also of different materials, such as stainless steel and/or other alloys such as Nickel-Titanium; and of different cross-sectional shapes, such as round, square or rectangular; and of different sizes e.g. 0.016 inch round and 0.018 by 0.022 inch rectangular etc. The wires are ligated to the brackets in various ways to permit low-friction, sliding mechanics, for example. Typically, the first phase of this biomechanical orthodontic correction is leveling using round wires, followed by more detailed tooth re-orientation using rectangular or square wires. Other corrections, such as space closure, are often accomplished by using elastics attached to the brackets or coil springs along the arch-wire to pull or push teeth into positions as determined by the orthodontic clinician. From the patients' viewpoint, apart from esthetic considerations, one of the drawbacks of conventional fixed appliances is the trauma that the metallic orthodontic components and/or elastics may cause. The inside surface mucosa of the cheeks and lips, as well as the tongue, routinely contacts the metallic orthodontic components and/or elastics during swallowing, speech and mastication, which can cause cheek-biting, painful mouth ulcers, etc. In addition, inappropriate forces and moments that reach or exceed physiologic blood pressure during fixed orthodontic treatment can cause root resorption, by producing stresses in the periodontium. To avoid high pressures, the acting forces need to remain below about 0.5N. These levels of forces can be achieved by using Nickel-Titanium (NiTi) wires with a diameter of 0.012-inches, for example. The use of NiTi wires ensures an almost constant moment (torque) based on its stiffness, spring-back, shape memory, and elasticity. A superior NiTi alloy wire was developed by the Furukawa Electric Co., Ltd., Japan. This Japanese NiTi wire exhibits “super-elasticity” in that this particular wire delivers a constant force over an extended portion of its deactivation range. This Japanese NiTi alloy wire undergoes minimal permanent deformation during activation, and its stress remains nearly constant despite the change in strain within a specific range. This unique feature is called ‘super-elasticity’. Moreover, Titanium-Niobium-Aluminum (Ti—Nb—Al) springs generate lighter and more continuous forces. Thus, Ti—Nb—Al wire has superior mechanical properties for smooth, continuous tooth movement, and Ti—Nb—Al wire may be used as a nickel-free, shape-memory and super-elastic alloy wire for orthodontic tooth movement instead of Ni—Ti wire. Similarly, NiTi coil springs, used with elastic chains, can generate nearly constant forces over a wide range of activation due to low load deflection. Reducing the load deflection rates of orthodontic springs is important, as it provides relative constancy of the moment-to-force ratio applied to the teeth with concomitant, predictable tooth movements. Lower load deflection rate springs increase patient comfort and reduce the number of office visits, while lowering potential tissue damage. Using 0.016″×0.022″ NiTi and multi-stranded arch wires employed in a 0.018″ slot system, with power-hooks or up-righting springs, bodily tooth movements can be achieved. But, friction may increase if the up-righting torque is too strong and other unwanted side effects such as tooth extrusion, rotation and tipping can also occur. Therefore, the load-deflection rate of an orthodontic spring depends on the modulus of elasticity of the utilized alloy and the geometric configuration of the spring. Thus, it is usually preferable to choose springs with a low load-deflection rate of about 50 p/mm (50 kN/mm 2 ). Nevertheless, it has been found that the force systems produced by straight wire and conventional up-righting springs can show severe extrusive force components, which may lead to occlusal trauma. Furthermore, intra-oral adjustment of up-righting springs is difficult because of high susceptibility to minor modifications of geometry. Prior art had described the design and construction of the stainless steel flap springs utilized, including springs constructed of heat-treated alloy wire transversely orientated against the palatal/lingual surfaces of the pertinent teeth. Nevertheless, palatal finger springs; open springs; boxed springs; cranked palatal springs; re-curved springs, double cantilever or Z-springs, and T-springs etc. that are transversely orientated against the palatal/lingual or mesial/distal surfaces of the pertinent teeth are commonly found in the orthodontic literature as known by those skilled in the art. Indeed, the use of acrylic buttons attached to the palatal/lingual surfaces of pertinent teeth has been commonly deployed to prevent the transversely orientated spring from riding up the palatal/lingual tooth surface. Thus, there remains a need for improved treatment methods, systems, and devices that utilize springs that harness the underlying developmental mechanisms—encoded at the level of the gene. Further, such improved treatment methods, devices, and systems should utilize cyclic intermittent forces to induce sutural osteogenesis. Additionally, there remains a need for a spring with cyclic functionality as a key component of a system and method to bioengineer vibrational orthopedic-orthodontic devices. SUMMARY OF THE INVENTION The present invention provides a device, system, and treatment method for correcting common orthodontic and craniofacial abnormalities. In one preferred embodiment, the present invention includes a vibrational orthopedic-orthodontic appliance adapted to induce craniofacial homeostasis by triggering the patient's genome. One objective of the invention is to increase, enhance, optimize and augment craniofacial homeostasis, equilibrium and balance. The present invention further contemplates a system comprising a device including a removable orthodontic appliance with active plates. Its framework is a base plate made from acrylic or a similar (thermoplastic) material. The appliance or device comprises an acrylic body that incorporates various components within its two halves as shown in FIG. 1 . This component serves as a base in which the various components are embedded and onto which clasps, bands or bonded brackets are attached directly or indirectly ( FIG. 2 ). The active elements of the device can be vibrational, ultrasonic or oscillatory components with an actuator or other expansion mechanism that straddles the two parts of the body plate ( FIG. 3 ). The tooth-contacting material can be high-elasticity, pre-formed alloys that are custom-formed to adapt to the long axis of the palatal/lingual surfaces of the teeth. These materials can be adjusted as required by the clinician. Alternatively, electrical ultrasonic/vibrational, meso-motors or micro-motors can be located between the two halves of the body plate. These ultrasonic/vibrational motors can have their characteristics varied manually or through the use of a microprocessor, chip or programmable integrated circuit. In addition, these small electrical motors adjust the separation of the two plate halves automatically through the use of pressure sensors in contact with several tooth surfaces to ensure the device remains in contact with the tissues without having to manually adjust the appliance. These sensors can be used to monitor, download and measure the pressure applied to each tooth or groups of teeth. The sensors can be located in other positions, such as the body plate to record readings in the roof of the mouth or floor of the mouth, and to provide soft tissue pressure measurements. In addition, by using a global positioning system changes in tooth position could be monitored, downloaded and measured for calculations and predictive modeling of changes using appropriate computer software. Further adjustments can then be made by applying an electric current to the micro- or meso-motors, assisted by the readings of the output of the sensors and/or the global positioning system. For these reasons, a microprocessor will be provided embedded within the body plate. To power the microprocessor, a battery or cell is also provided, similar to those used for hearing aids or bone conductors. The microprocessor is supplied via conducting wires with information from the pressure sensors, and its output can drive the ultrasonic/vibrational, micro-motors or meso-motors, via other conducting wires at least partially embedded in the plastic body, in order to automatically keep the vibrational pressure on the teeth and tissues at a pre-set level. Furthermore, the dental healthcare provider can create a therapy profile that will lead to a good outcome for each patient. For example, the force vectors need to be cyclic, intermittent, long-acting, low-level and consistent so as not to over do the application of force and produce an inferior result. This profile may be in the form of data or digital codes stored in a memory that is part of the microprocessor. Thus the microprocessor would control the motors based on the profile data and the readings from the sensors. The intra-oral device is attached to at least two permanent or deciduous teeth using clasps, bands or direct bonding to the surfaces of the teeth with orthodontic brackets. A labial bow and other wires in the form of springs can also be provided as required. The body of the device lies in close approximation to the patient's tissues, especially in the palate in the maxillary version of the appliance; and on the lingual areas in the mandibular version of the appliance. In addition, extensions of the plate body symmetrically overlay the biting (occlusal) surfaces of at least two of the patient's teeth in the space where those teeth would normally contact the opposing teeth from the upper or lower jaw. The thickness of the occlusal coverage ranges from approximately 0.5 mm to approximately 5.0 mm, as determined by orthodontic equilibration, and may be absent in certain locations or spots, if required. The plate body itself has a thickness that varies, and ranges from about 1.0 mm to about 5.0 mm, depending upon the components embedded within it. Micromechanical, cyclic, tensile and/or compressive forces and/or doses of oscillatory strain will be applied using an ultrasonic/vibrational component similar to that found in ultrasonic dental scalers, electric toothbrushes, ultrasonic dental cleaning appliances and cellular telephones. The range of force applied will be very low and vary between 0.1-10N although forces of other magnitudes may be applied as required. The frequency applied will vary between 1-600 Hz although other ranges of cycles may be applied as required. The device will be activated for 10-60 minutes per day although other durations of application may be used as required. The overall duration of the ultrasonic/vibrational therapy will last between 5-14 consecutive days or non-consecutive days e.g. alternate days, although other durations of therapy will be used as required, depending on the patient's response, as it is thought that frequent small activations of a midline screw-mechanism or actuator are more effective than a few large ones. The device may be used in conjunction with conventional fixed orthodontic appliances (braces), if required. It may also be used as a component in a two-phase orthopedic-orthodontic treatment. The device should be equally applicable to child, teenage and adult dental patients. One preferred embodiment includes two or more retentive (Adams or Delta or Crozat) clasps to hold the appliance in place while it is being worn. These Adams or Delta or Crozat clasps are attached to the molar teeth and provide good retention. In one preferred embodiment the appliance includes a passive acrylic baseplate connecting the two halves with an intervening midline jack-screw. In an alternate preferred embodiment the appliance includes a memory- or posture-pedic smart material for the baseplate. This active baseplate will help remodel the underlying bone as tooth movement proceeds. Another preferred embodiment of the present invention includes a method for achieving concurrent craniofacial correction, combining simultaneous orthopedic and orthodontic therapies without the use of typical biomechanical forces. The method comprises: (a) introducing appliances into the oral cavity that alter the spatial relations or the bite of the jaws and teeth; (b) adjusting the appliances to achieve intimate contact with oral structures, including the teeth, but without the use of force that push or pull on the teeth; (c) inducing an intermittent, non-continuous, cyclic stimulus or stimuli that reach a physiologic threshold to evoke mechanoreceptors present within craniofacial sutures, including the periodontium; (d) permitting tissue remodeling to occur such that the appliances lose intimate contact with oral structures, including the teeth; and (e) re-adjusting the appliance or appliances to re-establish intimate contact. This method is further adopted to include adjusting the amount of correction relative to an individual patient's genome. Additionally, the time of correction depends on the individual's genome. Notably, this method does not require the application of orthodontic brackets to the teeth. However, in an alternative embodiment, the present method adapts to cooperate with orthodontic brackets applied to the teeth. In yet another alternative preferred embodiment, the method adapts to cooperate with orthodontic wires applied to orthodontic brackets applied to the teeth. One possible device or appliance according to another preferred embodiment of the present invention includes an orthopedic-orthodontic appliance for inducing remodeling of craniofacial hard and soft tissues comprising: (a) a removable oral appliance composed of a discontinuous hard acrylic base plate wherein the discontinuous hard acrylic includes extensions overlaying an occlusal surface of posterior teeth bilaterally; (b) a tooth contacting material, which is anchored to the hard acrylic and contacts the palatal/lingual surface of at least one tooth; wherein the contacting material has the ability to produce and transmit intermittent, cyclic signals to said palatal/lingual surface of said tooth; and (c) a midline medio-lateral actuator, which permits separation of said two halves of hard acrylic, wherein the hard acrylic includes clasps, which are anchored to said hard acrylic and attach to said posterior teeth bilaterally. Further, this contacting material is a wire composed of a single strand of alloy. Alternatively, the contacting material is a braided wire composed of a plurality of strands of alloy. In yet another preferred embodiment, the contacting material is orientated at an angle approximately parallel to the long axis of said tooth. In yet another preferred embodiment, the oral appliance includes a contacting material comprising a lever arm of a vibrational meso-motor capable of producing intermittent, cyclic signaling. In yet another preferred embodiment, the oral appliance further includes a vibratory signal contacting the palatal lingual surface of one tooth is produced by ultrasonic technology. Additionally, the acrylic overlay of posterior teeth bilaterally is about 5 mm in thickness or less. And, the vibratory signal is produced by intermittent contact of opposing teeth in the maxillary and mandibular dental arches, during sleep, swallowing, speech and mastication, for example. In yet another preferred embodiment, a three-dimensional (3-D) axial spring design is described wherein said spring is orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root (see FIG. 4 ). Said 3-D axial spring lies on palatal/lingual surface of the contiguous oral structures (mucosa) orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root (see FIG. 4 ). FIG. 5 illustrates the three axes, including transverse (from side to side across the tooth), antero-posterior (from the front biting edge of the tooth back towards the gum), and vertical (spring loops extending up away from the tooth, and down towards the tongue). The 3-D axial spring design wherein the active (compression-extension) axis of the spring is orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root, instead of it lying approximately parallel to the transverse axis of the palatal/lingual surface of the crown of said tooth is described. The initial arm 30 of said 3-D axial spring is embedded in a discontinuous acrylic base-plate, and the terminal arm 30 of said 3-D axial spring is embedded in said acrylic base-plate, both arms 30 lying in approximately the same vertical axis. Said initial arm 30 and said terminal arm 30 are connected by a plurality of undulating U-bends that comprise the body of said 3-D axial spring. Said plurality of U-bends may vary in amplitude, being bigger or smaller in size. Said plurality of U-bends may vary in frequency, being many or few in number. Said plurality of U-bends may vary in characteristic, being differently shaped, such as a ‘Z’ formation or a square waveform etc. Said plurality of U-bends in said initial and said terminal arms 30 of said body of said 3-D axial spring lie in close approximation with respect to each other for the entire length of said active (compression-extension) axis of said 3-D axial spring. Said 3-D axial spring lies on palatal/lingual surface of the contiguous oral structures (mucosa) orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root (see FIG. 4 ). The head of said 3-D axial spring intimately contacts the long axis of said palatal/lingual surface of said tooth (see FIG. 4 ). The three-dimensional (3-D) axial spring design as in FIGS. 5A , 5 B, and 5 C whereby a plurality of said 3-D axial springs are orientated approximately parallel to the long axis of said palatal/lingual surface of said tooth/root or a plurality of said teeth/roots (see FIG. 3 ). The 3-D axial spring design wherein one active (compression-extension) arm 30 of said 3-D axial spring is orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root, and the other active (compression-extension) arm 30 of said 3-D axial spring is lying approximately parallel to the transverse axis of said palatal/lingual surface of the crown of said tooth. The initial arm 30 of said 3-D axial spring is partially or fully embedded in a discontinuous acrylic base-plate, and the terminal arm 30 of said 3-D axial spring is embedded in said acrylic base-plate, both arms 30 lying at approximately 90-degrees or less with respect to each other (see FIG. 3 ). Said initial arm 30 and said terminal arm 30 consist of and are connected by a plurality of undulating U-bends that comprise the body of said 3-D axial spring. Said plurality of U-bends may vary in amplitude, being bigger or smaller. Said plurality of U-bends may vary in frequency, being many or few. Said plurality of U-bends may vary in characteristic, being differently shaped. The arrangement of said plurality of U-bends is in an open configuration for the entire length of said active (compression-extension) arms 30 of said 3-D axial spring. Said initial arm 30 of said 3-D axial spring lies on palatal/lingual surface of the contiguous oral structures (mucosa) orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root (see FIG. 4 ). Said terminal arm 30 of said 3-D axial spring is orientated at an angle approximately parallel to said transverse axis of said palatal/lingual surface of said tooth, not contacting any hard or soft tissues; however, head of said active (compression-extension) arm 30 of said 3-D axial spring orientated at an angle approximately parallel to said transverse axis of said palatal/lingual surface of crown of said tooth, lies in intimate contact with said palatal/lingual surface of crown of said tooth. The 3-D axial spring design as in FIGS. 5A-5C whereby a plurality of said 3-D axial springs are interconnected by a plurality of U-bends approximately parallel to the long axis of said palatal/lingual surface of said tooth/root or a plurality of said teeth/roots, said plurality of U-bends lying on palatal/lingual mucosa of said teeth and/or roots (see FIGS. 3 and 4 ). DRAWING FIG. 1 is a bottom view of a device according to a preferred embodiment of the present invention. FIG. 2 is a top view of the device of FIG. 1 . FIG. 3 is a bottom view of an alternative embodiment according to the present invention. FIG. 4 is a partial side view showing the embodiment of FIG. 3 in relationship to a tooth of a patient. FIG. 5A is an offset frontal view of a three-dimensional axial spring device and method according a preferred embodiment of the present invention. FIG. 5B is a side view of the 3-D axial spring of FIG. 5A . FIG. 5C is a top view of the 3-D axial spring of FIG. 5A . FIG. 6 shows a device according to a preferred embodiment of the present invention used to treat the lower jaw and teeth of a patient. FIG. 7 illustrates a patient's teeth at the beginning of treatment according to a method of the present invention. FIG. 8 illustrates the patient of FIG. 7 after one week of the treatment method. FIG. 9 is a representational diagram of a computer system according to one embodiment of the present invention. FIG. 10 is a “before” drawing of a patient. FIG. 11 is an “after” drawing representing the patient of FIG. 10 after a method according to the present invention was applied. FIG. 12 illustrates a patient's teeth before the device and method of the current invention was applied. FIG. 13 illustrates a patient's corrected teeth after the device and method of the present invention was applied. FIG. 14 is a side view of a patient before the device and method of the current invention was applied. FIG. 15 is a side view of a patient after the device and method of the present invention was applied. DESCRIPTION OF THE INVENTION Possible preferred embodiments will now be described with reference to the drawings and those skilled in the art will understand that alternative configurations and combinations of components may be substituted without subtracting from the invention. Also, in some figures certain components are omitted to more clearly illustrate the invention. The present invention, in a first preferred embodiment, includes a treatment method including the following procedures: The clinician should first be able to visualize the effects of ideal facial development for a given patient. Next, a clinical examination of the head, neck and facial area is performed followed by a postural evaluation. Diagnostic imaging is then performed using lateral cephalographs, panoral radiography, computerized tomography, Cone-beam CT scan, and/or MRI. Photographic images are also taken intra-orally, extra-orally, and posturally. Three-dimensional techniques such as stereophotogrammetry or laser scan should also be performed. Subsequent to medical imaging, an electro-diagnostic analysis is performed using Joint Vibrational Analysis (JVA), Electromyography (EMG), and Electrognathology (EGN). Impressions of the maxillary and mandibular arches should be taken to produce study models, which can be laser scanned to create digital study models. Prior to the induction of craniofacial homeostasis, a treatment protocol is developed with the goal of visualizing the treatment objective. The foregoing treatment plans need to be based on what is termed the osteogenetic-orthodontic concept, i.e., the growth and development of the craniofacial region can be influenced by signaling using an osteogenetic-orthodontic appliance. Data-driven predictive modeling with computer analyses may be utilized where available. The following steps must be followed prior to the induction of craniofacial homeostasis: Evaluation of facial features should include assessments of: facial asymmetry, intercanthal angle, sclera, venous pooling, and lower eyelid of the patient. The vertical and antero-posterior axes of the ears should be noted. Asymmetry of the nares, morphology of the dorsum, and relative size of the nose should be noted, including the depth of the nasolabial grooves. The form of the lips should be examined for: asymmetry, thin upper lip, dry and/or everted lower lip, and the depth of the labiomental groove. Facial profile analysis should include: frontonasal angle, cranial base length, facial proportions, under-developed midface/maxilla with or without midfacial retrognathia, underdeveloped mandible with or without retrognathia (retruded position). Esthetic Line of the face is assessed. This is the measurement of the midface in relation to the cranial base, and represents the fullness of the facial profile. It is the distance from the tip of the nose to the incisal edge of the upper incisor in the midline. This measurement should be approximately 38 mm in adults. Protocol for the Induction of Craniofacial Homeostasis: With the foregoing steps accomplished, the next step is the foundational correction treatment protocol by which facial development for maximum medical improvement is enhanced by achieving skeletal and dental balance, equilibrium and homeostasis. The desired results from a successful protocol are: 1) Correcting the size and shape of the maxilla; 2) Correcting the size, shape and position of the mandible; and, 3) Bringing the mandible into occlusion with the maxilla, and maintaining the corrected spatial relations (including the posture of the tongue, lips etc.). Treatment Planning: Proper treatment planning will take into account the following: 1) Correcting skeletal midline to soft tissue midline; 2) Correcting occlusion to Class I molar/cuspid relationship; and, 3) Correcting condyles to symmetrical positions. For patients having space less than 2 mm (Class I Christiansen effect): Step 1. Development of Maxilla Insert upper osteogenetic-orthodontic appliance with snug or intimate fit; Occlusal coverage should be adjusted to avoid open-bite; anterior teeth should be edge to edge; Wear osteogenetic-orthodontic appliance at night-time, or additionally as indicated; Turn screw approximately once per week (abut 0.25 mm), or more or less as required. If maxilla is not ready for the turn, the patient should wait until it is ready (i.e. when the appliance feels loose). Step 2. Development of Mandible Upper appliance should be used for about 3 to about 6 months (or as required) before insertion of lower appliance. Insert lower osteogenetic-orthodontic appliance with snug or intimate fit. Stop developing the maxilla but have patient continue to wear the upper appliance. Mandible should be developed until it occludes with the maxillary arch. Turn screw approximately once per week (about 0.25 mm, or more or less as required in a particular patient's case). If mandible is not ready for the turn, the patient should wait until it is ready (i.e. when the appliance feels loose). For Steps 1 and 2: Try to avoid complete buccal crossbite during development. Anterior 3-D axial springs are activated to re-position teeth to ideal esthetic line measurement, approximately. 3-D axial springs are activated for tooth alignment, if needed. Step 3. Finish Treatment Adjust upper and lower appliances simultaneously until optimally-desired results are reached. Balance any facial asymmetries as far as possible Step 4. Retention Maintain balance; Continue using osteogenetic-orthodontic appliance(s) at night only. For Steps 1-4: Rate of development depends on individual; and Time of treatment depends on rate of development. For patients having space more than 2 mm (Class II Christiansen effect): Step 1. Development of Maxilla Insert upper osteogenetic-orthodontic appliance with snug fit. Patient continues using day-time orthotic repositioning appliance for day wear, including eating. As maxilla develops, adjust day-time re-positioner appliance as required. If patient wakes up with pain, construct an NTI appliance (night orthotic) for use during sleep. Turn screw approximately about once per week (about 0.25 mm), or as required (more or less frequently). If maxilla is not ready for the turn, the patient should wait until it is ready (i.e. when the appliance feels loose). When Christiansen effect is 2 mm or less, construct lower osteogenetic-orthodontic appliance Step 2. Development of Mandible Insert lower osteogenetic-orthodontic appliance with snug fit. Remove day-time re-positioner appliance. Stop developing the maxilla. Turn screw approx. once per week (0.25 mm). If mandible is not ready for the turn, the patient should wait until it is ready (i.e. when the appliance feels loose). Mandible should be developed until it occludes with the maxillary arch. For steps 1-2. Rate of development depends on individual. Time of treatment depends on rate of development. Avoid complete buccal crossbite. Activate anterior 3-D axial springs for tooth alignment as needed. Step 3. Finish Treatment Adjust upper and lower appliances simultaneously until optimally-desired results are reached. Balance any facial asymmetries as far as possible. Step 4. Retention Maintain balance. Continue using osteogenetic-orthodontic appliance(s) at night only. The Functional Correction treatment protocol is directed toward enhancing facial development by achieving extra-oral (facial) and intra-oral soft tissue balance, equilibrium and homeostasis for maximum medical improvement. This is achieved through: 1) Developing the muscles of the face (muscles of facial expression); 2) Developing the muscles of the jaws (muscles of mastication); 3) Maintaining corrected spatial relations (posture of tongue, lips etc.); and, 4) Losing features of craniofacial obesity where indicated. A treatment plan is developed which takes into account: 1) Correcting extra-oral soft tissues; 2) Correcting intra-oral soft tissues; and, 3) Correcting tongue posture to enhance functional airway space. The method developed includes facial therapy to workout facial muscles approximately 10 mins. per day and oral myofunctional therapy to correct oral muscles, including the tongue. This treatment method just described results in before and after conditions of the patient as exemplified in FIGS. 10-11 , for example. In a second preferred embodiment, and well-suited for use with the treatment method previously described, the present invention includes an orthodontic device or appliance 10 of FIGS. 1-6 . FIGS. 1 , 2 and 3 show an orthodontic device or appliance 10 of the split palate type in accordance with one preferred embodiment of the present invention. Device 10 includes a plate body 12 , preferably of plastic material, such as acrylic. The plate body is preferably in two halves 12 A, 12 B, but it can be in one piece or in several pieces of unequal size. Plate body 12 has overlay 14 extending from it to a position that would cover the top of a tooth. While it is shown with one such overlay 14 A on the left side in FIG. 3 , it should be understood that the overlay 14 B is on the right side. The location and extent of the overlay 14 is based on a clinical determination by the dental health care provider to achieve the desired equilibration in an optimal way. A first clasp 16 and a second clasp 18 are connected to the plate; preferably by being embedded in the plastic material of plate body 12 . Each clasp 16 , 18 includes an archway 20 , 22 for selectively permitting device 10 to be fitted about a tooth, preferably one of the posterior teeth, to hold the device or appliance in place. When fitted or connected, overlay 14 A may be positioned to extend over one of the archways (archway 20 is shown in FIG. 3 , with overlay 14 B additionally extending over archway 22 ) so as to be in contact with the teeth. Overlay 14 is preferably placed on top of the teeth adjacent to archway 20 or 22 of the respective clasp 18 , 20 , thereby preventing the jaw from fully closing. The halves 12 A, 12 B of plate body 12 may be connected by an expansion jack screw 24 . While the screw 24 may be manually adjustable to control the separation of the plate halves, a small electrical micro-motor 25 may incorporate the screw 24 and be used to adjust the separation. A labial bow 26 , in the form of an arch wire, is also connected to the plate body 12 , preferably by being embedded in the plastic material of the plate body 12 . Labial bow 26 wraps around the front of the teeth and additionally acts to keep device 10 in place. A plurality of 3-D axial springs 28 , which are also known in the art as Singh springs in FIG. 2 , for example—or in an alternative preferred embodiment as the Singh spring 29 shown in FIGS. 5A , 5 B, and 5 C, for example—are coupled or otherwise connected to the plate body, preferably by being embedded in the plastic material of the plate body 12 . Each 3-D axial spring 29 includes an arm portion 30 and a head portion 32 . As is common, the head portion 32 rests against the inside of the teeth and contacts the patient's tissues at that location. Typically, the amount of contact can be adjusted by manual bending of the arm portions 30 . As an alternative, small electrical motors 35 can be located between the body plate 12 and one or more of the 3-D axial springs 28 to adjust the contact that the 3-D axial springs have to the patient's teeth and tissues without having to manually bend the springs. In addition, sensors can be located at the ends of the 3-D axial springs where they meet the teeth in order to measure the pressure applied to each tooth or group of teeth by the 3-D axial spring. The sensor can be located in other positions, but in such a case it would not provide a direct measurement of the pressure and some calculation would be necessary to arrive at the actual pressure. During use of the device, as the jaw expands and other bones develop, it will be necessary to adjust the separation of the body plates 12 A, 12 B, as well as the contact of the 3-D axial springs, in order to continue the development of the bones. This can be accomplished during periodic visits, e.g., once a week, to the dental health care provider for adjustments. Such adjustments can be manual or, where the motors 25 , 35 are present, they can be made by applying an electric current to the motors. In part, the output of sensors can be read by the dental health care provider to better adjust the appliance. A microprocessor 40 can be provided on or embedded within the body plate 12 . In order to power the microprocessor, a battery 42 would also be provided. The microprocessor may be supplied via conducting wires with information from the sensors and its output can drive the micro-motors 25 , 35 , via other conducting wires at least partially embedded in the plastic body 12 , in order to automatically keep the contact on the teeth at a preset level. In this way patient errors such as missed, over-zealous or reversed screw-turns are eliminated, and the visits to the dental healthcare provider are reduced to an optimized level. Further, the dental healthcare provider can create a force profile that will lead to a desired outcome for the patient. For example, the vectors need to be intermittent, cyclic, long-acting, low-level and consistent so as not to over do the application of force and produce an inferior result. This profile may be in the form of data or digital codes stored in a memory that is part of the microprocessor. Thus the microprocessor controls the motors based on the profile data and the readings from the sensors. The plate body 12 does not include the clasps 16 , 18 , the labial bow 26 , and the 3-D axial springs 28 or 29 . The body 12 of device 10 , except for the overlay 14 , is slightly spaced from the patient's tissue, including the palate and mandibular lingual areas. Therefore, the only portion of the plate body 12 that touches the patient's tissues is the overlay 14 , which contacts the biting (occlusal) surface of at least one of the patient's teeth in the space where that tooth would normally contact an opposing tooth from the opposite set of teeth, i.e., upper or lower jaw. The overlay 14 is sufficiently thick to prevent the jaws from fully closing. The thickness of the overlay, where it contacts the tooth preferably ranges from approximately about 0.5 mm to approximately about 2 mm. But, the overlay can have a thickness ranging from approximately about 0 mm to approximately about 5.0 mm. The plate body 12 has a thickness that varies and ranges from about 1 mm to about 5 mm. To change the form of the jaw and facial bones with device 10 , the device is placed within the mouth of a patient so that overlay 14 contacts at least one tooth and the remainder of the plate body 12 is spaced from the patient's tissue, including the palate. Overlay 14 prevents the patient's jaws from fully closing. It is believed that this contact of the teeth with the overlay causes intermittent forces to be applied to the body plate 12 and through it to the 3-D axial springs 28 , 29 to the teeth. This cyclic intermittent signaling stimulates the patient's genome during function, essentially each time the patient speaks, swallows, smiles etc., which is estimated to be about 2,000 to 3,000 times per day/night. This frequent cyclic intermittent signaling on the facial and alveolar bones is believed to cause development of the facial and jaw bones where jaw development did not fully occur during childhood. This bone development may include a descent of the palate (i.e., remodeling of the vault of the palate downwardly toward the lower jaw); a widening of the palate; an upward and outward remodeling of the body of the maxilla; and an increase in palatal length, if necessary. FIGS. 7 , 10 , 12 and 14 show the teeth and mouth of a patient at the beginning of treatment prior to use of the device 10 of the present invention. FIGS. 8 , 11 , 13 and 15 is the same patient after partial treatment (for one week) of the device 10 . It should be noted that the teeth have been re-positioned more favorably in the “after” figures of 8 , 11 , 13 and 15 when compared to the “before” FIGS. 7 , 10 , 12 , and 14 ). In effect the jawbone has been developed to accommodate the new position of the teeth. Notice that tooth X and tooth Y are now better aligned because of the effects of the device 10 . This alignment was brought about by the application of intermittent cyclic signals to the patient's tissues. During function, e.g., as the patient swallows while wearing the device, either while awake or asleep, the teeth come into contact with the overlay 14 , which applies signals through the device to the bones of the jaw. This repetitive signaling causes stimulation of the genes that encode the bones of the jaw and face. While not wishing to be held to any theory of operation, it is believed that the symmetrical nature of the result of the reformation of the teeth and jaw bones is not due entirely to the application of force to specific areas of bone, but to the developmental mechanisms encoded at the genetic level of the patient, as predicted by the Spatial Matrix Hypothesis of Singh. The vibrational signals from the 3-D axial springs (for example spring 28 , 29 of FIGS. 1-6 ) stimulate the patient's jaw (alveolar) and facial bone genes while wearing the device, which is estimated to be for about 20-30 minutes per day and/or while sleeping at night. This frequent, cyclic, intermittent signaling of the facial and alveolar bones causes development of the facial and jaw bones that did not occur optimally during childhood. This bone development may include remodeling of the palate, eruption of the teeth, remodeling of the facial bones and jaws etc., according to the patient's genome. It should be noted that the teeth are expected to relocate outwards; in effect the jawbone will be expanded to accommodate the new positions of the teeth, without any new spacing occurring between individual teeth. The spring 28 and 29 is also known as an orthodontic spring and comprises a resilient material. Suitable materials, well-understood in this art, include, for example, a Titanium-Niobium-Aluminum (Ti—Nb—Al) alloy, a Cobalt-Chromium-Nickel alloy, also known under the trade name “Elgiloy®” available from Elgiloy Specialty Alloys of Elgin, Ill., USA, or a NiTi wire that exhibits “super-elasticity”. Additionally, the spring 28 and 29 is further comprised of a wire composed of a single strand of alloy. Alternatively, this spring is constructed from a braided wire composed of a plurality of strands of a single alloy. In yet another embodiment, this spring is constructed from a braided wire composed of a plurality of strands of a plurality of alloys. Other contemplated alloys include a Nickel-free β-titanium alloy. Further, the spring 28 , 29 includes a spring body having an arm 30 and oppositely spaced head 32 . The spring body further includes three axes of movement. The three axes include a transverse axis (from side to side across the tooth), an antero-posterior axis (from the front biting edge of the tooth back towards the gum), and a vertical axis (spring loops extending up away from the tooth, and down towards the tongue). Although the invention has been particularly shown and described with reference to certain embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the invention.

1a

FIELD OF THE INVENTION The present invention relates to a new indigestible polysaccharide containing matrix for a controlled release of an active principle. The present invention also relates to the use and method for making the same. BACKGROUND OF THE INVENTION The local treatment of Inflammatory Bowel Diseases (e.g., Crohn's Disease and Ulcerative Colitis) is highly challenging, because conventional dosage forms rapidly release the drug in the upper gastro intestinal tract (GIT). Upon absorption into the blood stream the drug is distributed throughout the human body, resulting in potentially severe side effects. In addition, the drug concentration at the site of action—the inflamed colon—is low, leading to low therapeutic efficacies. To overcome these restrictions, drug release from the dosage form should ideally be suppressed in the stomach and small intestine, but set on as soon as the target site is reached. Different interesting approaches have been described in the literature to allow for site specific drug delivery to the colon upon oral administration. Generally, a drug reservoir is surrounded by a film coating, which is poorly permeable for the drug in the upper GIT, but becomes permeable as soon as the colon is reached. The change in drug permeability of the film coating might be caused by: (i) the change in the pH of the contents of the GIT (stomach—small intestine—colon), (ii) degradation of the film coating by enzymes, which are secreted by colonic bacteria, or (iii) structural changes in the film coating as soon as the target site is reached (e.g., rupturing after a certain lag time, due to a steadily increasing hydrostatic pressure within the dosage form). Furthermore, drug release might start right after oral administration at a rate which is sufficiently small in order to assure that drug is still present in the dosage form once the colon is reached. However, great care must be taken, because the conditions in the GIT of a patient suffering from Crohn's Disease or Ulcerative Colitis might significantly differ from those in a healthy subject. In particular, the pH values and transit times within the various GIT segments as well as the quality and quantity of the colonic microflora can be very different from those under physiological conditions. Thus, a dosage form which might reliably deliver a drug specifically to the colon in a healthy subject might fail in a patient. Also, the intra- and inter-variability of the dosage form's performance can be expected to be considerable if the onset of drug release is not induced in the disease state. Recently, an Indigestible polysaccharide (IPS), more particularly a branched polysaccharide containing film coatings has been proposed for colon targeting in Inflammatory Bowel Disease patients. This branched polysaccharide is a water-soluble, indigestible polysaccharide with high fiber contents, obtained from wheat starch. Importantly, it serves as a substrate for enzymes secreted from colonic bacteria present in the feces of patients suffering from Crohn's Disease and Ulcerative Colitis. However, so far, only IPS-based film coatings have been described. In these cases, a drug containing reservoir is surrounded by a continuous film, which avoids premature drug release into the contents of the stomach and small intestine. Yet, the potential of matrix systems containing an indigestible polysaccharide as colon targeting compound is unknown. The concept of matrix systems is fundamentally different from that of film coated dosage forms. There is no “reservoir—membrane” structure. The drug is more or less homogeneously distributed throughout the dosage form. This type of devices can also be called “monolithic systems” or “one-block-systems”. There is no complete local separation of the drug depot on the one hand side and the release rate controlling film coating on the other hand side. In these cases, the drug is embedded within the release rate controlling material. Since IPS as well as the most frequently used drug for the local treatment of Inflammatory Bowel Diseases [5-aminosalicylic acid (5-ASA)] are water soluble at 37° C., an additional, water-insoluble excipient is needed, for instance a lipid. MMX® is a technology used in the commercial product Lialda® aiming at colon specific delivery of 5-ASA. The idea is to embed the drug within a lipid matrix (carnauba wax and stearic acid) and to disperse this phase within a hydrogel consisting mainly of sodium carboxymethylcellulose and sodium starch glycolate. The drug-lipid-hydrogel mixture is compressed into tablets, which are film coated with Eudragit® S and Eudragit® L. Thus, this system requires a coating step and it is a single unit dosage form, suffering from the all-or-nothing effect and an eventually non-homogeneous distribution within the contents of the GIT. The aim of the invention was to prepare and characterize novel, multiparticulate dosage forms (matrix pellets and mini tablets) usable uncoated or coated and containing the colon targeting compound IPS and high doses of an active agent such as 5-ASA. The high drug content is of major practical importance, because up to 4.8 g 5-ASA is administered per day. Different types of lipids were added to minimize premature drug release in the upper GIT and the effects of various formulation and processing parameters were studied. The present invention also relates to a method for producing such controlled release composition. SUMMARY OF THE INVENTION An object of the present invention is to provide a delivery dosage form to control the rate and extent of delivery of an active ingredient, for example, without limitation an active pharmaceutical ingredient, biological, chemical, nutraceutical, agricultural or nutritional active ingredients. Another object of the present invention is to provide a controlled-release oral pharmaceutical composition comprising a dose of an active ingredient, comprising a lipophilic matrix and a hydrophilic matrix, wherein the hydrophilic matrix comprises the indigestible polysaccharide according to the invention. The active ingredient may be at least partly inglobated in the lipophilic matrix which is then dispersed in the hydrophilic matrix when the active ingredient is hydrophobic. Inversely, when the active ingredient is hydrophilic, it may be dispersed in at least one part of the hydrophilic matrix which is then dispersed in the lipophilic matrix. The obtained granules may be subsequently dispersed in the other part of the hydrophilic matrix. Alternatively at least one active ingredient may be dispersed in each hydrophilic and lipophilic matrix prior to there mix. The present invention provides a controlled-release oral pharmaceutical composition of at least an active agent, comprising: a) a lipophilic matrix consisting of lipophilic compounds and/or amphiphilic compounds; b) an hydrophilic matrix, wherein the hydrophilic matrix comprises at least an indigestible polysaccharide, the active ingredient being dispersed in the lipophilic and/or the hydrophilic matrix. Advantageously, the indigestible polysaccharide according to a preferred embodiment is selected from a group consisting of xylooligosaccharide, inulin, oligofructose, fructo-oligosacharide (FOS), lactulose, galactomannan, indigestible polydextrose, indigestible dextrin, trans-galacto-oligosaccharide (GOS), xylo-oligosaccharide (XOS), acemannan, lentinan, beta-glucan, polysaccharide-K (PSK), indigestible maltodextrin and partial hydrolysates thereof. Preferably, the indigestible polysaccharide is a polysaccharide having between 15 and 50%, preferably between 20 and 40%, more preferably between 25 and 35% of 1→6 glucoside linkages, a reducing sugar content of less than 20%, preferably between 2 and 18%, more preferably between 2.5 and 15%, even more preferably between 3.5 and 10.5%, typically between 4.5 and 8%, a polymolecularity index of less than 5, preferably between 1 and 4%, more preferably between 1.5 and 3%, and a number-average molecular mass Mn at most equal to 4500 g/mol, more preferably between 500 and 3000 g/mol, more preferably between 700 and 2800 g/mol, more preferably between 1000 and 2600 g/mol. In a preferred embodiment, the indigestible polysaccharide is a branched maltodextrin or dextrin. The indigestible polysaccharide according to the invention advantageously provides the controlled release effect of the pharmaceutical composition without the need of a colon targeting outer coating. The embedding matrix being a barrier to the premature releasing of the active ingredients, that is, before the colon is reached. Different physico-chemical phenomena might be involved in the control of drug release from the dosage forms described in this invention. This might potentially include for example: (i) the penetration of water into the dose form upon contact with aqueous body fluids, (ii) the dissolution of incorporated drug particles, (iii) the diffusion of dissolved drug molecules or ions through hydrophilic and lipophilic matrices, (iv) the swelling of hydrophilic compounds, (v) the dissolution of hydrophilic compounds, (v) the enzymatic degradation of system compounds, (vi) the creation of water-filled pores, through which dissolved drug molecules might diffuse. The combination of hydrophilic matrix compounds according to the invention with lipophilic matrix compounds confers a controlled release of the active principle and optimized drug concentrations at the site of action. The composition of the invention can further contain conventional excipients, for example bioadhesive excipients such as chitosans, polyacrylamides, natural or synthetic gums, acrylic acid polymers. In an embodiment of the present invention, the lipophilic matrix comprises lipophilic compounds selected from unsaturated and/or hydrogenated C6-C22 alcohols or fatty acids (preferably C8-C22 fatty acids) salts, esters or amides thereof; fatty acids with glycerol or sorbitol or other polyalcohols (preferably fatty acid mono-, di- or triglycerids, polyoxyethylated derivatives thereof); waxes, ceramides, cholesterol derivatives long chain aliphatic alcohols. In a further embodiment of the present invention, the fatty acid polyalcohol is at least one selected from the group consisting of cetostearyl alcohol, stearyl alcohol, lauryl alcohol and myristyl alcohol; fatty acid ester is at least one selected from the group consisting of glyceryl monostearate, glycerol monooleate, acetylated monoglyceride, tristearin, tripalmitin, cetyl ester wax, glyceryl palmitostearate and glyceryl behenate; and wax is at least one selected from the group consisting of beeswax, carnauba wax, glyco wax and castor wax. Typically, the lipophilic compound is selected from soybean oil, glyceryl tristearate, glyceryl tripalmitate, glyceryl behenate, glyceryl palmitostearate, hydrogenated cottonseed oil and hydrogenated soybean oil. In a further embodiment of the invention, the lipophilic matrix comprises amphiphilic compounds selected from polar lipids of type I or II (lecithin, phosphatidylcholine, phosphatidylethanolamine), ceramides, glycol alkyl ethers such as diethylene glycol monomethyl ether (Transcutol®), polyoxyethylenated castor oil, sodium laurylsulfate, polysorbates, phosphoacetylcholine. Preferably, the active ingredient is embedded in the lipophilic and/or hydrophilic matrix by kneading, extrusion, granulation and/or spray drying. Those different technologies provide an intense mixing of the ingredients. Advantageously, the percentage of the active ingredient on the total composition weight ranges from 1 to 95%, preferably 5 to 90%, more preferably 10 to 80%, the percentage of the lipophilic matrix on the total composition weight ranges from 2.5 to 85%, preferably 15 to 80%, more preferably 20 to 70%, even more preferably 35% to 60%, the percentage of the hydrophilic matrix on the total composition weight ranges from 2.5 to 35%, preferably 10 to 30, more preferably 12 to 25%, even more preferably 15 to 20%. The hydrophilic matrix further includes but is not limited to celluloses or their salts or derivatives thereof, hydroxyethylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, alginic acid or their salts and derivatives thereof, carbomer (Carbopol™), polyethyleneoxide, xanthan gum, guar gum, locust bean gum, poly vinyl acetate, polyvinyl alcohol. According to a first embodiment, the lipophilic matrix is an inner matrix and the hydrophilic matrix is an outer matrix, the lipophilic matrix preferably forming lipophilic matrix granules containing the active ingredient. Typically, the lipophilic matrix granules containing the active ingredient are mixed with the hydrophilic matrix in a weight ratio ranging from 100:0.5 to 100:50 (lipophilic matrix: hydrophilic matrix). According to a second embodiment, the hydrophilic matrix is an inner matrix and the lipophilic matrix is an outer matrix, the hydrophilic matrix preferably forming hydrophilic matrix granules containing the active ingredient. Typically, the hydrophilic matrix granules containing the active ingredient are mixed with the hydrophilic matrix in a weight ratio ranging from 100:0.5 to 100:50 (hydrophilic matrix: lipophilic matrix). According to a third embodiment, different active ingredients may be embedded in lipophilic matrices and hydrophilic matrices and both lipophilic and hydrophilic granules may then be embedded in lipophilic and/or hydrophilic matrices. According to a first alternative, the composition is an uncoated solid form. This solid form is advantageously easy to be obtained. According to another advantageous alternative the composition is a coated solid form comprising an outer coating. The outer coating may contain another active ingredient with a different releasing profile. Typically, said outer coating is a gastro-resistant coating or colon-targeting coating. Preferentially, the outer coating comprises hydrophobic release-modifying polymer, hydrophilic release-modifying polymer, pH-dependent release-modifying polymer or a mixture thereof, preferably methacrylic acid polymers or cellulose derivatives. In a preferred embodiment, the outer coating is 1 to 20% by weight to total weight of the composition, and the matrix containing the drug reach 50 to 80% by weight to total weight of the composition. The hydrophilic release-modifying polymer used for the formation of release-modifying layer, is at least one selected from the group consisting of ethylcellulose, shellac and ammonio methacrylate copolymer; said hydrophilic release-modifying polymer is at least one selected from the group consisting of hydroxyalkylcellulose and hydroxypropylalkylcellulose; and said pH-dependent release-modifying polymer is at least one selected from the group consisting of hydroxyalkylcellulose phthalate, hydroxyalkylmethylcellulose phthalate, cellulose acetyl phthalate, sodium cellulose acetate phthalate, cellulose ester phthalate, cellulose ether phthalate, and anionic copolymer of methacrylic acid with methyl or ethyl methacrylate. According to a first variant of the invention, the composition according to the invention is in the form of granules, pellets, tablets, capsules, minitablets, wherein the active ingredient is dispersed in the lipophilic matrix and/or the hydrophilic matrix. Typically, the active ingredient is further dispersed in the outer coating. According to a further embodiment, the active ingredient is an aminosalicylate active agent preferably chosen from 4-amino salicylic acid, 5-amino salicylic acid, and pharmaceutically acceptable salt or enantiomer or polymorph or metabolites, esters or pro-drugs thereof. The present invention also provides a process for the preparation of the compositions according to the invention, which comprises: a) kneading or mixing a first matrix with at least an active ingredient for forming granules; b) mixing the granules from step a) with a second matrix and optionally a subsequent step of compression and/or compaction and/or extrusion and/or spray drying; wherein at least one of the matrices is an hydrophilic matrix and the other one is an lipophilic matrix, the lipophilic matrix containing lipophilic and/or amphiphilic compounds and the hydrophilic matrix comprising at least an indigestible polysaccharide. Advantageously, the indigestible polysaccharide, according to a preferred embodiment, is selected from a group consisting of xylooligosaccharide, inulin, oligofructose, fructo-oligosacharide (FOS), lactulose, galactomannan and suitable hydrolysates thereof, indigestible polydextrose, indigestible dextrins and partial hydrolysates thereof, trans-galacto-oligosaccharides (GOS), xylo-oligosaccharides (XOS), acemannans, lentinans or beta-glucans and partial hydrolysates thereof, polysaccharides-K (PSK), and indigestible maltodextrins and partial hydrolysates thereof. Preferably, the indigestible polysaccharide has between 15 and 50%, preferably between 20 and 40%, more preferably between 25 and 35% of 1→6 glucoside linkages, a reducing sugar content of less than 20%, preferably between 2 and 18%, more preferably between 2.5 and 15%, more preferably between 3.5 and 10.5%, typically between 4.5 and 8%, a polymolecularity index of less than 5, preferably between 1 and 4%, more preferably between 1.5 and 3%, and a number-average molecular mass Mn at most equal to 4500 g/mol, more preferably between 500 and 3000 g/mol, more preferably between 700 and 2800 g/mol, more preferably between 1000 and 2600 g/mol. According to an advantageous embodiment, the process comprises a further step of film-coating of the oral solid forms from step b). Preferably, the step a) of kneading or mixing the active ingredient with a first matrix is carried out in the absence of solvents or water-alcoholic solvents. In a further embodiment, the process according to the invention comprises a curing time preferably at 40 to 80° C., more preferably 50 to 60° C. This thermal after-treatment might lead to changes in the inner system structure: Lipid compounds might at least partially melt and embed more efficiently drug particles. Preferably the step a) is an extrusion and/or a granulation. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 : 5-ASA release from pellets consisting of 60% drug, 15% IPS and 25% lipid: (a) hardened soybean oil, (b) glyceryl tristearate, (c) Sasolwax® or Synthetic Wax, or (d) Microwax® HG or Microwax® HW. The release medium was 0.1 N HCl (for the first 2 h) and phosphate buffer pH 6.8 (for the subsequent 8 h). The curing conditions are indicated in the diagrams. FIG. 2 : Effects of the replacement of 10% hardened soybean oil by MCC or PVP (as indicated) on 5-ASA release from pellets containing 60% drug and 15% IPS. The reference formulations contained 25% hardened soybean oil. The curing conditions are indicated in the diagram, the release medium was 0.1 N HCl for 2 h, followed by phosphate buffer pH 6.8 for 8 h. FIG. 3 : Effects of an additional long term curing on drug release from pellets consisting of 60% 5-ASA, 15% IPS and 25% lipid (the type is indicated in the diagram) upon exposure to 0.1 N HCl (for 2 h) and phosphate buffer pH 6.8 (for 8 h). The solid curves indicate drug release from pellets, which were only cured for 3 min at 90° C. The dotted curves show drug release from pellets, which were additionally cured for 7 days at 40° C. FIG. 4 : DSC thermograms of pellets consisting of 60% 5-ASA, 15% IPS and 25% glyceryl palmitostearate or tripalmitate. The curing conditions are indicated in the diagram. For reasons of comparison, also thermograms of 5-ASA, IPS and the lipid powders as received are shown. FIG. 5 : Impact of the presence of enzymes in the bulk fluid [0.32% w/v pepsin in 0.1 N HCl (for 2 h), and 1% w/v pancreatin in phosphate buffer pH 6.8 (for 8 h)] on 5-ASA release from pellets consisting of 60% drug, 15% IPS and 25% lipid (the type is indicated in the diagram). All pellets were cured at 90° C. for 3 min, followed by 7 days at 40° C. FIG. 6 : Long term stability (under stress conditions) of pellets containing 60% 5-ASA, 15% IPS and 25% glyceryl palmitostearate: Drug release in 0.1 N HCl (for 2 h) and phosphate buffer pH 6.8 (for 8 h) from systems, which were cured for 3 min at 90° C., optionally followed by 7 days or 6 months at 37, 40 or 45° C. (as indicated). FIG. 7 : 5-ASA release from mini tablets consisting of 50% drug, 15% IPS and 35% lipid: (a) glyceryl tripalmitate, glyceryl tristearate, or hardened soybean oil, (b) glyceryl behenate or glyceryl palmitostearate, (c) hydrogenated cottonseed or hydrogenated soybean oil. Drug release was measured in 0.1 N HCl for 2 h and phosphate buffer pH 6.8 for 8 h. The curing conditions are indicated in the diagrams. All tablets were prepared by direct compression. FIG. 8 : Effects of the curing conditions on 5 ASA release from mini tablets consisting of 50% drug, 15% IPS and 35% glyceryl palmitostearate in 0.1 N HCl (for 2 h) and phosphate buffer pH 6.8 (for 8 h). All tablets were prepared by direct compression. FIG. 9 : Effects of the type of preparation method: direct compression versus partial melt granulation & compression versus separate melt granulation & compression versus melt granulation & compression. Details on the different preparation methods are given in the text. The mini tablets consisted of 50% drug, 15% IPS and 35% glyceryl palmitostearate. The release medium was 0.1 N HCl during the first 2 h, followed by phosphate buffer pH 6.8 during the subsequent 8 h. FIG. 10 : Effects of the replacement of 5% glyceryl palmitostearate by chitosan on 5-ASA release from mini tablets (prepared by melt granulation & compression). The systems consisted of 50% drug, 15% IPS and 35% glyceryl palmitostearate [5% of which was replaced by chitosan, if indicated]. The release medium was 0.1 N HCl during the first 2 h, followed by phosphate buffer pH 6.8 during the subsequent 8 h. FIG. 11 : Impact of the IPS content and curing conditions on 5-ASA release from mini tablets containing 50% drug and 50% “IPS+glyceryl palmitostearate” in 0.1 N HCl (for 2 h) and phosphate buffer pH 6.8 (for 8 h). The curing conditions are indicated in the diagram. All tablets were prepared by melt granulation & compression. DETAILED DESCRIPTION OF THE INVENTION In describing and claiming the present invention, the following terminology is used in accordance with the definitions set out herein. As used herein, the term “active ingredient”, “drug” or “pharmacologically active ingredient” or any other similar term means any chemical or biological material or compound suitable for administration by the methods previously known in the art and/or by the methods taught in the present invention, that induces a desired biological or pharmacological effect, which may include but is not limited to (1) having a prophylactic effect on the organism and preventing an undesired biological effect such as preventing an infection, (2) alleviating a condition caused by a disease, for example, alleviating pain or inflammation caused as a result of disease, and/or (3) either alleviating, reducing, or completely eliminating the disease from the organism. The effect may be local, such as providing for a local anaesthetic effect, or it may be systemic. As used herein, the term “controlled release delivery” or “controlled release” means that the release of the active ingredient out of the dosage form is controlled with respect to time or with respect to the site of delivery. The term “coat” is used herein to encompass coatings for solid supports and also capsules enclosing fluids and/or solids and the term “coated” is used similarly. The expression “water insoluble polymer” should be understood broadly, this expression refers to polymers that do not completely dissolve in water, such as for example ethyl cellulose, certain starch derivatives or acrylic acid/methacrylic acid derivatives. The term “indigestible polysaccharide” as used in the present invention refers to saccharides which are not or only partially digested in the intestine by the action of acids or digestive enzymes present in the human upper digestive tract (small intestine and stomach) but which are at least partially fermented by the human intestinal flora. Indigestible polysaccharide that may be employed in preferred embodiments of the invention are polysaccharides containing indigestible glucosidic linkages conferring on those saccharides additional properties identical to dietetic fibers such as “branched polysaccharides”. In the sense of the invention, by branched maltodextrins or dextrins is meant maltodextrins or dextrins, of which the content of glucosidic linkages 1→6 is greater than that of standard maltodextrins or dextrins. For example, standard maltodextrins are defined as purified and concentrated mixtures of glucose and glucose polymers essentially linked in 1→4 with only 4 to 5% glucosidic linkages 1→6, of extremely varied molecular weights, completely soluble in water and with low reducing power. Examples of those indigestible polysaccharides are polydextrose, branched dextrins or branched maltodextrins such as those described in patent EP 1 006 128, of which the applicant company is the proprietor. In practice, the number average molecular mass (Mn) and the weight average molecular mass (Mw) values which allow a better definition of the polymolecular species of the polymer mixtures, are measured by gel permeation chromatography, on chromatography columns calibrated with dextrans of known molecular weight (Alsop et al., Process Biochem, 12, 15-22; 1977 or Alsop et al., Chromatography 246, 227-240; 1982). This method of measurement is very suitable for glucose polymers and is the method used within the context of the present invention. The index of polymolecularity (I.P.) that is the ratio Mw/Mn makes it possible to characterize overall the distribution of the molecular weights of a polymer mixture. The indigestible polysaccharide according to the present invention have a total fiber content of greater than or equal to 50% on a dry basis, determined according to AOAC method No. 2001-03 (2001). The invention provides novel polymeric film coatings for colon targeting which are adapted to the disease state of the patients suffering from inflammatory bowel diseases. In the following, the invention will be illustrated by means of the following examples as well as the figures. EXAMPLE A. Materials and Methods A.1. Materials Aminosalicylic acid (5-ASA; Falk Pharma, Freiburg, Germany); glyceryl behenate (Compritol® 888 ATO) and glyceryl palmitostearate (Precirol® ATO 5) (Gattefosse®, St. Priest, France); hydrogenated soybean oil (Sterotex® HM) and hydrogenated cottonseed oil (Sterotex® NF) (Abitec, Janesville, Wis., USA); glyceryl trimyristate/glyceryl tripalmitate/glyceryl tristearate/hardened soybean oil (Dynasan® 114/116/118/120) and synthetic hard paraffines (Sasolwax® Spray 30 and Synthetic Wax) (Sasol, Witten, Germany); IPS (NUTRIOSE® FB 06; Roquette Freres, Lestrem, France); microcristalline cellulose (MCC, Avicel PH 101; FMC BioPolymer, Brussels, Belgium); poly(vinylpyrrolidone) (PVP, Povidone® K30) (Cooperation Pharmaceutique Francaise, Melun, France); chitosan (Protasan® C1 213; Novamatrix®, FMC BioPolymer, Drammen, Norway); Microwax® HG and Microwax® HW (Paramelt, Heerhugowaard, The Netherlands); pancreatin (from mammalian pancreas=mixture of amylase, protease and lipase) and pepsin (Fisher Bioblock, Illkirch, France). NUTRIOSE ® FB06 Number average molecular mass Mn 2640 (g/mole) Number average molecular weight Mw 4941 (g/mole) Mn/Mw 1.9 1-6 links 29-32 Reducing sugar 3.9 A.2. Preparation of Matrix Pellets 5-ASA loaded matrix pellets were prepared by extrusion-spheronisation. The drug, IPS and the respective lipid(s) were blended and granulated manually with demineralized water in a mortar with a pestle. The obtained wet mass was extruded using a cylinder extruder with two counter-rotating rollers (1 mm orifice, 3 mm thickness, extrusion speed=32 rpm, GA 65 extruder; Alexanderwerk, Remscheid, Germany). The extrudates were subsequently spheronised (Caleva model 15; Caleva, Dorset, UK) for 180 s at 364 rpm. The obtained pellets were dried for 24 h in an oven at 40° C. and sieved (fraction: 0.71-1.00 mm). If indicated, the pellets were cured for specific time periods at defined temperatures in an oven. A.3. Preparation of Mini Tablets 5-ASA, IPS and the respective lipid(s) were blended manually in a mortar with a pestle. Mini tablets were prepared by: (i) direct compression on a Frank 81802 (Karl Frank, Birkenau, Germany), equipped with a 2 mm diameter punch set (Korsch, Berlin, Germany), or (ii) compression of granules obtained via melt granulation. If not otherwise stated, the respective compounds were heated and mixed on a water bath at 85° C. After cooling to room temperature, the obtained mass was ball milled, sieved (fraction 50-100 μm) and compressed using the same equipment as in (i). The tablet height was 2 mm. Optionally, the tablets were cured in an oven for different time periods at various temperatures, as indicated. A.4. Drug Release Measurements Drug release from matrix pellets was measured in 120 mL cylindrical plastic flasks (diameter: 5.5 cm, height: 6.5 cm) containing 100 ml release medium: 0.1 N HCl (optionally containing 0.32% w/v pepsin) for 2 h and phosphate buffer pH 6.8 (USP 32) (optionally containing 1.0% w/v pancreatin) for 8 h (complete medium change after 2 h). The flasks were agitated in a horizontal shaker (37° C., 80 rpm, n=3) (GFL 3033; Gesellschaft fuer Labortechnik, Burgwedel, Germany). At pre-determined time points, 3 mL samples were withdrawn (replaced with fresh medium), filtered and analyzed UV-spectrophotometrically at λ=302.4 nm (0.1 N HCl), or λ=331.2 nm (phosphate buffer pH 6.8) (UV-1650PC; Shimadzu, Champs-sur-Marne, France). In the presence of enzymes, the samples were centrifuged at 13,000 rpm for 10 min (Universal 320 centrifuge; Hettich, Tuttlingen, Germany) and filtered (0.2 μm, PTFE) prior to UV measurements. Drug release from mini tablets was measured using the USP 32 apparatus 3 (Bio Dis; Varian, Les Ulis, France) (37° C., 5 dpm, n=3) in 200 mL release medium: 0.1 N HCl for 2 h and phosphate buffer pH 6.8 (USP 32) for 8 h (complete medium change after 2 h). At pre-determined time points, 3 mL samples were withdrawn (replaced with fresh medium), filtered and analyzed UV-spectrophotometrically as described above. A.5. Determination of Drug Solubility Excess amounts of 5 aminosalicylic acid were placed in contact with 0.1 N HCl and phosphate buffer pH 6.8 at 37° C. in a horizontal shaker (80 rpm, GFL 3033). Samples were withdrawn every 12 h, filtered and analyzed for their drug content as described in section 2.4. until equilibrium was reached. A.6. DSC Analysis Thermograms of different types of pellets and raw materials (for reasons of comparison) were measured by differential scanning calorimetry (DSC1; STARe Software; Mettler Toledo SAS, Viroflay, France). Pellets were gently crushed in a mortar with a pestle and approximately 7 mg samples were heated in sealed aluminum pans (investigated temperature range: 20 to 90° C., heating rate: 10° C./min). B. Results and Discussion B.1. IPS-Containing Matrix Pellets Extrusion-spheronisation allowed obtaining spherical pellets in all cases. The systems contained 60% 5 ASA, 15% IPS and 25% lipid(s) (optionally partially replaced by MCC or PVP). The high drug loading is of great practical importance, because 5 ASA is highly dosed (up to 4.8 g per day). The presence of IPS in the pellets aims at providing colon specific drug delivery: This polymer has been reported to be degraded by enzymes present in feces of Inflammatory Bowel Disease patients. The lipids, MCC and PVP aim at avoiding immediate drug release upon contact with aqueous body fluids (note that the drug and IPS are both water soluble at 37° C.). FIG. 1 shows the release of 5 ASA from pellets containing 25% (w/w) of the following lipids: (a) hardened soybean oil, (b) glyceryl tristearate, (c) Sasolwax® or Synthetic Wax, or (d) Microwax® HG or Microwax® HW. The systems were cured at different temperatures for 1, 2 or 3 min (as indicated) in order to allow for a more homogeneous lipid distribution, more efficient embedding of the drug particles and eventually the (partial) transformation of a lipid into a more stable modification. The melting points of the investigated lipids (glyceryl tristearate: 70-73° C., hardened soybean oil: 67 72° C., Sasolwax®: 96 100° C., Synthetic Wax: 94 97° C., Microwax® HG: 80 86° C., Microwax® HW: 75 80° C.) were close to or well below the investigated curing temperatures. As it can be seen in FIG. 1 , immediate drug release is avoided and the release rate generally decreased with increasing curing temperature and time, irrespective of the type of lipid. Thus, in principle the applied strategy is successful. However, in all cases drug release was too rapid and most of the drug was released during the observation period (corresponding to the simulated transit period through the upper GIT; note that long residence times have been assumed, simulating unfavorable conditions for the drug delivery system). Hence, premature drug release in vivo is highly likely. The fact that after complete medium change (at t=2 h), the release rate decreased in most cases can probably (at least partially) be attributed to the lower aqueous solubility of 5 ASA in phosphate buffer pH 6.8 compared to 0.1 N HCl at 37° C.: 4.4 mg/mL versus 10 mg/mL. In order to reduce the undesired premature drug release in 0.1 N HCl and phosphate buffer pH 6.8, parts of the lipid were substituted by MCC or PVP. FIG. 2 shows 5-ASA release from pellets containing 60% drug, 15% IPS, 15% hardened soybean oil and 10% MCC or PVP. For reasons of comparison, also drug release from MCC/PVP-free systems (containing 25% hardened soybean oil) is shown. All pellets were cured for 3 min at 70, 80 or 90° C. (as indicated). Interestingly, the replacement of 10% (w/w, referred to the total system mass) lipid by MCC resulted in accelerated drug release, irrespective of the curing conditions. Thus, the lipid is more efficient in hindering drug release from these pellets than MCC. In contrast, the partial replacement of hardened soybean oil by PVP led to slightly/moderately decreased drug release rates, if the systems were cured at 70 and 80° C. However, upon curing at 90° C., also in this case drug release was accelerated upon lipid substitution. Thus, these approaches are not suitable to effectively minimize premature drug release in the upper GIT. In a further attempt to avoid the observed undesired drug release in 0.1 N HCl and phosphate buffer pH 6.8, a short term curing for 3 min at 90° C. was followed by a long term curing at 40° C. for 7 days. FIG. 3 shows 5-ASA release from pellets containing 25% glyceryl trimyristate, hardened soybean oil, glyceryl behenate, glyceryl palmitostearate, glyceryl tripalmitate, hydrogenated cottonseed oil, or glyceryl tristearate upon exposure to 0.1 N HCl for 2 h, followed by phosphate buffer pH 6.8 for 8 h (dotted curves). For reasons of comparison, also drug release from pellets, which were only cured for 3 min at 90° C. are shown (solid curves). Clearly, the release rate significantly decreased in most cases upon long term curing. This can at least partially be attributed to changes in the modifications of the lipids: FIG. 4 shows exemplarily DSC thermograms of pellets consisting of 60% 5-ASA, 15% IPS and 25% glyceryl palmitostearate or tripalmitate (as indicated). The pellets were cured for 3 min at 90° C. and optionally subsequently for 7 days at 40° C. For reasons of comparison, also thermograms of 5-ASA, IPS and of the lipid powders as received are shown in FIG. 4 . The melting peaks of the powders as received correspond to the melting peaks of the stable β-modifications of these lipids. In contrast, pellets which were only cured for 3 min at 90° C. also showed the melting/transformation of a less stable modification, irrespective of the type of lipid. Importantly, pellets cured for 7 days at 40° C. again only showed the melting of the stable lipid modification (in both cases). It has to be pointed out that the curing temperature during long term curing was well below the melting point of the respective lipids. Hence, the observed changes in the resulting drug release rates during long term curing are probably not caused by potential redistributions of the lipids. As lipids were used to slow down drug release within the upper part of the GIT, it was important to measure the effects of the presence of enzymes in the bulk fluids on drug release. FIG. 5 shows 5-ASA release from pellets consisting of 60% drug, 15% IPS and 25% hydrogenated cottonseed oil, glyceryl tripalmitate or glyceryl palmitostearate (as indicated). The release medium was either 0.1 N HCl for the first 2 h, followed by phosphate buffer pH 6.8 for the subsequent 8 h (solid curves), or 0.1 N HCl containing 0.32% w/v pepsin for the first 2 h, followed by phosphate buffer pH 6.8 containing 1% w/v pancreatin for the subsequent 8 h (dotted curves). All pellets were cured for 3 min at 90° C., followed by 7 days at 40° C. Clearly, drug release significantly increased in the presence of enzymes in the case of hydrogenated cottonseed oil and glyceryl tripalmitate, due to the (at least partial) degradation of these lipids. In contrast, the release rate only slightly increased in the case of glyceryl palmitostearate. Thus, this lipid seems to be much less affected by the added enzymes under these conditions. For this reason, glyceryl palmitostearate was used as standard lipid in all further experiments (if not otherwise stated). When developing controlled drug delivery systems, special care needs to be taken with respect to potential changes in the systems' properties during long term storage. Modifications in the molecular structures might alter the resulting matrix permeability for the drug and, thus, the release rate. For these reasons, it is of great practical importance to measure drug release before and after long term storage from such dosage forms. Storage under stress conditions (e.g., elevated temperature) can allow obtaining results more rapidly than under ambient conditions. FIG. 6 shows the release of 5-ASA from pellets consisting of 60% drug, 15% IPS and 25% glyceryl palmitostearate. The pellets were cured for 3 min at 90° C., followed by 7 days at 37, 40 and 45° C. (as indicated) (the melting range of glyceryl palmitostearate is 53 57° C.). For reasons of comparison, also drug release from pellets, which were only cured for 3 min at 90° C. and from pellets, which were cured for 3 min at 90° C., followed by 6 months at 37, 40 and 45° C. is illustrated. Clearly, a days curing is required to slow down drug release, irrespective of the curing temperature. Interestingly, the resulting release profiles do not overlap, indicating possible differences in the lipid distribution within the system. Importantly, drug release further slowed down when increasing the curing period to 6 months in the case of curing at 37° C., but not in the case of curing at 40 or 45° C. Thus, the latter pellets are likely to be stable during long term storage at room temperature. B.2. IPS-Containing Mini Tablets As an alternative to matrix pellets, also mini tablets (diameter: 2 mm; height: 2 mm) consisting of 50% 5-ASA, 15% IPS and 35% lipid were prepared. Again, the high drug loading was important because of the high daily doses of 5-ASA. IPS was the colon targeting compound and the lipid was intended to minimize drug release in the upper GIT. To evaluate the suitability of different types of lipids in these dosage forms, hardened soybean oil, glyceryl tristearate, glyceryl tripalmitate, glyceryl behenate, glyceryl palmitostearate, hydrogenated cottonseed oil as well as hydrogenated soybean oil were studied ( FIG. 7 ). The mini tablets were prepared by direct compression, followed by a curing for 24 or 48 h at 60, 65, 70 or 75° C. (as indicated), according to the melting points of the lipids: hardened soybean oil 67 72° C., glyceryl tristearate 70 73° C., glyceryl tripalmitate 63° C., glyceryl behenate 69 74° C., glyceryl palmitostearate 53 57° C., hydrogenated cottonseed oil 60 62.5° C. hydrogenated soybean oil 66.5 69.5° C. As it can be seen in FIG. 7 , drug release upon 2 h exposure to 0.1 N HCl, followed by 8 h exposure to phosphate buffer pH 6.8 is considerable in all cases. Generally, the release rate decreased with increasing curing time and temperature, due to altered lipid modifications and/or lipid distribution within the system. As in the case of matrix pellets, glyceryl palmitostearate showed the most promising potential as release rate controlling lipid. For this reason it was studied in more detail. In order to minimize the undesired, premature drug release in the upper GIT, the curing time and temperature were further increased. FIG. 8 shows 5-ASA release from mini tablets consisting of 50% drug, 15% IPS and 35% glyceryl palmitostearate. The systems were cured for 3 min at 90° C., followed by 7 days, 14 days or 1 month at 40° C., or by 12, 24 or 48 h at 60° C. For reasons of comparison, also 5-ASA release from mini tablets cured for 24 h at 60° C. is shown. Clearly, the release rate was not very much affected by the curing conditions, except for the 1 month curing. As the latter is difficult to realize at an industrial scale and as the release rate still remains considerable, this approach was not further investigated. Since the distribution of the lipid within the mini tablets can be expected to significantly alter its ability to hinder drug release, four different preparation techniques were studied, which are likely to result in a more or less intense embedding of the drug within the glyceryl palmitostearate: (i) direct compression, (ii) partial melt granulation & compression, (iii) separate melt granulation & compression, and (iv) melt granulation & compression. In the case of “partial melt granulation & compression”, 5-ASA, IPS and 60% of the glycerol palmitostearate were molten at 85° C. on a water bath, cooled down to room temperature, ball milled and sieved (fraction 50-100 μm). The obtained powder was blended with the remaining glyceryl palmitostearate and compressed. In the case of “separate melt granulation & compression”, glyceryl palmitostearate and IPS were blended in equal parts and molten at 85° C. on a water bath. The remaining glyceryl palmitostearate was blended with the drug and also this blend was molten at 85° C. on a water bath. Both melts were cooled down to room temperature, ball milled, sieved (fraction 50-100 μm), blended and compressed. In the case of “melt granulation & compression”, all compounds were molten together at 85° C. on a water bath, cooled down to room temperature, ball milled, sieved (fraction 50-100 μm) and compressed. The mini tablets were optionally cured for 24 h at 60° C. As it can be seen in FIG. 9 , the drug release rate decreased in the following ranking order: direct compression>partial melt granulation & compression>separate melt granulation & compression>melt granulation & compression. This was true for uncured as well as for cured mini tablets and can probably be attributed to a more and more intense embedding of the drug within the lipid. As also chitosan has been reported to allow for site specific drug delivery to the colon, the partial substitution of glyceryl palmitostearate by chitosan was studied. FIG. 10 shows drug release from mini tablets consisting of 50% ASA, 15% IPS, 30% glyceryl palmitostearate and 5% chitosan. For reasons of comparison, also drug release from mini tablets free of chitosan (containing 35% glyceryl palmitostearate) is shown. All systems were prepared by melt granulation & compression. The tablets were either uncured or cured for 24 h at 60° C. (as indicated). Clearly, the presence of only 5% chitosan significantly increased the resulting drug release rate, leading to undesired, premature drug release. This was true for uncured as well as for cured tablets and can be attributed to the higher permeability of the hydrogel chitosan for the low molecular weight drug 5-ASA and/or rapid leaching of this compound into the surrounding bulk fluid at low pH. It has to be pointed out that an enteric coating can avoid an undesired dissolution of chitosan at low pH. Such composition is suitable for a use in a coated form. FIG. 11 shows the effects of the IPS content (while keeping the “IPS+glyceryl palmintostearate content” constant at 50%) and of the curing conditions on the resulting drug release kinetics from mini tablets prepared by melt granulation & compression upon exposure to 0.1 N HCl for 2 h and subsequent exposure to phosphate buffer pH 6.8 for 8 h. The IPS content was increased from 15 to 25% (while the glyceryl palmitostearate content was decreased from 35 to 25%), the tablets were optionally cured for 24 or 48 h at 60° C. (as indicated). As it can be seen, the release rate increased with increasing IPS content, because glyceryl palmitostearate is more effectively hindering drug release than IPS. Note that IPS is more effectively hindering drug release than chitosan in this type of dosage forms: When comparing 5-ASA release from mini tablets cured for 24 h at 60° C., containing 50% drug, 30% glyceryl palmitostaerate and 20% IPS (open squares and solid curves in FIG. 11 ) versus 15% IPS+5% chitosan (open squares in FIG. 10 ), it can be seen that drug release was slower in the case of 20% IPS. Furthermore, the release rate decreased with increasing curing temperature and time, irrespective of the IPS content ( FIG. 11 ). Importantly, at a IPS level of 15%, 5-ASA release from mini tablets cured at 60° C. for 24 and 48 h is virtually overlapping (open triangles: dotted and solid curves), indicating that a stable system is likely to be achieved. Thus, mini tablets consisting of 50% 5-ASA, 15% IPS and 35% glyceryl palmitostearate prepared by melt granulation & compression and subsequent curing for 24 h at 60° C. show an interesting potential for colon specific drug delivery.

1a

CLAIM OF PRIORITY [0001] This application claims priority to U.S. provisional application Ser. No. 60/992,370, filed Dec. 5, 2007, the entire disclosure of which is incorporated by reference herein. BACKGROUND OF THE INVENTION [0002] The present invention generally relates to orthotic devices and, in particular, an orthotic device that is designed to span the elbow and that are secured to an arm both above and below the elbow. [0003] Following a neurological injury, a patient often experiences upper limb involvement (hemiparesis). Often times the elbow presents with hypertonia or hypotonia. Hypertonia is when the elbow tends to, stay in the flexed position, and hypotonia is when the elbow is week and hangs down at the side. Hypotonia is often also referred to as flaccid. [0004] Orthotic devices that address the hemiparetic elbow conventionally include an upper component that attaches to the arm above the elbow and a lower component that attaches to the arm below the elbow. Furthermore, the upper component and the lower component are hinged together in pivotable disposition in the area of the elbow, and a biasing member typically biases the upper and lower components toward a particular orientation relative to one another and thereby urges the arm into flexion or extension, as the case may be. An example of such an orthotic device 100 is shown in FIGS. 1-3 . In particular, FIG. 1 is an overall perspective view of a conventional elbow orthotic 100 ; FIG. 2 is a partial perspective view of the orthotic 100 in a flexed position; and FIG. 3 is a partial perspective view of the orthotic 100 in a flexed position. As will be appreciated from review of FIGS. 1-3 , upper and lower arm components 102 , 104 of the orthotic 100 have overlapping portions that are hinged together at an axis 106 . [0005] A drawback to such conventional orthotic devices is that they tend to inhibit or otherwise interfere with movement of the forearm between pronation and supination. In this respect, it is important to note that the elbow flexes and extends; however, below the elbow the forearm pronates and supinates, which is to say that the forearm turns the hand palm down and palm up, respectively. This is anatomically done by the physical make up of two bones of the forearm, i.e., the Radius and the Ulna. Another drawback with conventional elbow orthotic devices is that they do not incorporate the hand functionally for grasp and release activities. [0006] An orthotic device in accordance with one or more preferred embodiments of the present invention addresses such drawback. SUMMARY OF THE INVENTION [0007] The present invention includes many aspects and features. [0008] In an aspect of the invention, an orthotic includes: (a) an upper component configured to be attached to an arm above the elbow; (b) a lower component configured to be attached to an arm below the elbow; and (c) one or more elongate intermediate components connecting the upper component and the lower component together, wherein the one or more intermediate component are elastic and wherein only the one or more intermediate components connect the upper and lower components together. [0009] In another aspect of the invention, an orthotic includes: (a) an upper component configured to be attached to an arm above the elbow; (b) a lower component configured to be attached to an arm below the elbow; and (c) one or more elongate intermediate components connecting the upper component and the lower component together, wherein the one or more intermediate component are elastic and wherein the upper and lower components are not hinged together. [0010] In a feature of one or more of these aspects, the orthotic is an elbow orthotic and is configured to urge the arm into flexion. [0011] In a feature of one or more of these aspects, the orthotic is an elbow orthotic and is configured to urge the arm into extension. [0012] In a feature of one or more of these aspects, the one or more intermediate components is an elastic cord. [0013] In a feature of one or more of these aspects, the one or more intermediate components is a flexible rod. [0014] In a feature of one or more of these aspects, the orthotic further includes a component that is attached to and extends from the upper component and that defines a point of tensional redirection in one of the intermediate components. [0015] Another aspect of the invention is a method of treating a hemiparetic elbow using an orthotic of any of the preceding aspects and features. [0016] Another aspect of the invention is a method of making/assembling the orthotic of any of the preceding aspects and features. [0017] In still yet another aspect, an upper arm component configured to be secured to an upper arm above the elbow and a component attached thereto and extending therefrom and configured to guide a line of tension from the upper arm component to a point of tensional redirection located below the elbow. [0018] In addition to the aforementioned aspects and features of the present invention, the present invention further encompasses the various possible combinations of such aspects and features. BRIEF DESCRIPTION OF THE DRAWINGS [0019] One or more preferred embodiments of the present invention now will be described in detail with reference to the accompanying drawings, wherein the same elements are referred to with the same reference numerals, and wherein: [0020] FIG. 1 is an overall perspective view of the conventional elbow orthotic. [0021] FIG. 2 is a partial perspective view of the orthotic of FIG. 1 in an extended position. [0022] FIG. 3 is a partial perspective view of the orthotic of FIG. 1 in a flexed position [0023] FIG. 4 is a perspective view of an elbow orthotic in accordance with a preferred embodiment of the present invention, wherein the arm is in a partially extended position. [0024] FIG. 5 is a perspective view of the elbow orthotic of FIG. 4 , wherein the arm is in a flexed position. [0025] FIG. 6 is a perspective view of an elbow orthotic in accordance with another preferred embodiment of the present invention. [0026] FIGS. 7-11 are different perspective views of an orthotic in accordance with another preferred embodiment of the invention. [0027] FIGS. 12-13 are different perspective views of another orthotic in accordance with a preferred embodiment of the invention. [0028] FIG. 14 illustrates an upper arm component in accordance with a preferred embodiment of the invention. [0029] FIG. 15 illustrates an upper arm component in accordance with another preferred embodiment of the invention. [0030] FIG. 16 illustrates an upper arm component in accordance with still another preferred embodiment of the invention. DETAILED DESCRIPTION [0031] As a preliminary matter, it will readily be understood by one having ordinary skill in the relevant art (“Ordinary Artisan”) that the present invention has broad utility and application. Furthermore, any embodiment discussed and identified as being “preferred” is considered to be part of a best mode contemplated for carrying out the present invention. Other embodiments also may be discussed for additional illustrative purposes in providing a full and enabling disclosure of the present invention. Moreover, many embodiments, such as adaptations, variations, modifications, and equivalent arrangements, will be implicitly disclosed by the embodiments described herein and fall within the scope of the present invention. [0032] Accordingly, while the present invention is described herein in detail in relation to one or more embodiments, it is to be understood that this disclosure is illustrative and exemplary of the present invention, and is made merely for the purposes of providing a full and enabling disclosure of the present invention. The detailed disclosure herein of one or more embodiments is not intended, nor is to be construed, to limit the scope of patent protection afforded the present invention, which scope is to be defined by the claims and the equivalents thereof. It is not intended that the scope of patent protection afforded the present invention be defined by reading into any claim a limitation found herein that does not explicitly appear in the claim itself. [0033] Thus, for example, any sequence(s) and/or temporal order of steps of various processes or methods that are described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal order, the steps of any such processes or methods are not limited to being carried out in any particular sequence or order, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and orders while still falling within the scope of the present invention. Accordingly, it is intended that the scope of patent protection afforded the present invention is to be defined by the appended claims rather than the description set forth herein. [0034] Additionally, it is important to note that each term used herein refers to that which the Ordinary Artisan would understand such term to mean based on the contextual use of such term herein. To the extent that the meaning of a term used herein—as understood by the Ordinary Artisan based on the contextual use of such term—differs in any way from any particular dictionary definition of such term, it is intended that the meaning of the term as understood by the Ordinary Artisan should prevail. [0035] Furthermore, it is important to note that, as used herein, “a” and “an” each generally denotes “at least one,” but does not exclude a plurality unless the contextual use dictates otherwise. Thus, reference to “a picnic basket having an apple” describes “a picnic basket having at least one apple” as well as “a picnic basket having apples.” In contrast, reference to “a picnic basket having a single apple” describes “a picnic basket having only one apple.” [0036] When used herein to join a list of items, “or” denotes “at least one of the items,” but does not exclude a plurality of items of the list. Thus, reference to “a picnic basket having cheese or crackers” describes “a picnic basket having cheese without crackers”, “a picnic basket having crackers without cheese”, and “a picnic basket having both cheese and crackers.” Finally, when used herein to join a list of items, “and” denotes “all of the items of the list.” Thus, reference to “a picnic basket having cheese and crackers” describes “a picnic basket having cheese, wherein the picnic basket further has crackers,” as well as describes “a picnic basket having crackers, wherein the picnic basket further has cheese.” [0037] Referring now to the drawings and, in particular, FIGS. 4-6 , one or more preferred embodiments of the present invention are next described. The following description of one or more preferred embodiments is merely exemplary in nature and is in no way intended to limit the invention, its implementations, or uses. [0038] In this regard, FIG. 4 is a perspective view of an elbow orthotic 400 in accordance with a preferred embodiment of the present invention, wherein the arm is in an extended position; and FIG. 5 is a perspective view of the elbow orthotic 400 wherein the arm is in a flexed position. Additionally, FIG. 6 is a perspective view of an elbow orthotic 600 in accordance with another preferred embodiment of the present invention that is similar in construction and design to orthotic 400 , but that further includes a padding component 602 as part of the orthotic 600 . [0039] In general, an orthotic of the present invention preferably comprises: an upper arm component that is configured to be secured to the upper arm above the elbow; and a lower arm component that is configured to be secured to the lower arm below the elbow. In particular, the lower arm section is secured to the wrist; to the wrist and hand; or to the wrist, hand, and fingers, as shown in FIG. 4 . [0040] In the orthotics 400 , 600 , the upper arm section preferably is in the form of a cuff 402 that is approximately 4 to 6 inches in length. As shown in FIGS. 4 and 7 , upper cuff 402 may have either a anterior or lateral opening in order to secure the cuff to the user's upper arm. The cuff is secured to the arm with one or more attachments such as straps, clasps, buckles, or the like. The lower arm component itself comprises forearm-wrist-hand orthotics 404 substantially as shown and described in U.S. Pat. No. 7,001,352, which is hereby incorporated herein by reference; however, other designs of the lower arm component are certainly with the scope of the present invention, and the invention is not limited to use only of orthotics 404 of this patent. [0041] In accordance with the present invention, upper arm component 402 and lower arm component 404 are connected by one or more elongate members 406 . In contrast to conventional elbow orthotics, the upper and lower arm components are not hinged together. [0042] In the illustrated embodiments of FIGS. 4-6 , the elongate members comprise elastic cords 406 each of which provides a line of tension in the orthotic that tends to bias the upper and lower arm components toward a particular orientation relative to one another. In particular, elastic cord 406 is attached both to upper arm component 402 and to lower arm component 404 . The attachments of elastic cord 406 can be accomplished, for example, using hooks, cleats, cams, clips, and the like. In the embodiment shown in FIG. 4 , cleats 407 and 409 are used. [0043] Furthermore, an outrigger 408 is attached to the posterior and/or lateral aspects of cuff 402 and can be adjustably mounted in the proximal and/or distal directions via additional attachment openings in the cuff. Outrigger 408 serves to guide each elastic cord 406 from cuff 402 to a point located below the apex of the elbow, from which elastic cord 406 extends and is attached to lower arm component 404 . This arrangement assists with pulling the elbow into an extension position. Outrigger 408 thus defines a point of tensional redirection that is located below the elbow. In a variation not shown, but which will be apparent to the ordinary artisan over the drawings disclosed and described herein, another attachment to the cuff may be provided that locates the point of tensional redirection above the apex of the elbow in order to assist the elbow into a flexed position. The tensional redirection of an elastic cord is achieved in the preferred embodiment by means of a pulley 410 , i.e., a freely rotatable wheel mounted at the distal end of the outrigger. FIGS. 7-16 shows another embodiment where redirection is achieved by a fixed end of outrigger 408 . [0044] When using elastic/shock cords to facilitate elbow extension, it is preferred that the cord or cords attach to outrigger 408 on upper component 402 , with a cord (or more cords if using more than one cord) passing down outrigger 408 , passing behind and being redirected below the apex of the elbow, and extending and attaching to lower component 404 . The adjustable force generated in various flexed positions will help pull the elbow back into an extension position. In this case, the tension/force mimics the non-functioning muscle (triceps) that moves the elbow into extension. It also provides resistance to the weakened non-functioning muscle (biceps) that moves the elbow into flexion, thus assisting with strengthening. [0045] When using elastic/shock cords to facilitate elbow flexion, it is preferred that the cord or cords attach to a site on the posterior or lateral aspect of upper arm component 402 , with a cord (or more cords if using more than one cord) passing above and being redirected above the apex of the elbow, and extending to attach to lower arm component 404 . The adjustable force then generated will help pull the elbow into a flexed position. In this case, the tension/force mimics the non-functioning muscle (biceps) that moves the elbow into flexion. It also provides resistance to the weakened non-functioning muscle (triceps) that moves the elbow into extension, thus assisting with strengthening. [0046] The attachment sites on the lower component may also allow for force/tension adjustments, such as when cleats/cams 407 are used in conjunction with elastic/shock cords (e.g. when pulling the elastic cord further through the cleat thus increasing the tension/force). [0047] As an alternative to elastic-cord 406 and -pulley 410 , an elongate energy storing material like spring steel or a flex rod may be used as the elongate member for connecting and biasing the upper and lower arm sections toward a particular orientation relative to one another. Various energy storing materials may be used, and different forces will be generated depending on the respective physical properties of such materials (e.g. a ⅛ of an inch diameter elastic/shock cord will offer less force than a 3/16 of an inch diameter elastic/shock cord). [0048] Outrigger 408 may also incorporate a padding component 602 at the posterior aspect of the elbow, as shown in FIG. 6 . Padding component 602 helps maintain the position of upper cuff 402 and lower cuff 404 is moved. [0049] Still yet, FIG. 7-11 are different perspective views of an orthotic 700 in accordance with another preferred embodiment of the invention. This orthotic 700 is similar to orthotic 400 in that it has an upper cuff 702 , lower arm component 704 that attaches to the forearm and hand and further spans the wrist. An outrigger 708 is releasably coupled to upper cuff 702 similar to that in the embodiments shown in FIGS. 4-6 . Elastic cord 706 coupled upper cuff 702 to lower cuff 704 . In contrast, FIGS. 12-13 are different perspective views of another orthotic 1200 in accordance with a preferred embodiment of the invention, wherein lower arm component 704 attaches only to the forearm. In this embodiment, upper cuff 1202 has two outriggers 1208 that redirect elastic cords 1206 . Cords 1206 connect to lower cuff 1204 by cleats 1207 (only one is shown in the figure). A pad 1210 is coupled to outrigger 1208 to provide additional upper arm support. As shown in FIG. 13 , pad 1210 is secured to outrigger 1208 by an adjustable spring clamp 1212 . [0050] FIGS. 14-16 illustrate variations of the upper arm component. In FIG. 14 , upper arm component 1400 has conduit guides 1402 that are attached to cuff 1404 by adjustable spring plates 1408 and 1414 and that receive therethrough the elastic cords (not shown for clarity). Moreover, the elastic cords are guided by bent or curved sections outrigger end sections 1406 located proximate to the end of the conduit guides as shown in FIG. 14 . For reference, upper arm component 1400 of FIG. 14 is utilized in the orthotic 700 of FIGS. 7-11 . [0051] In contrast, FIG. 15 is intended to illustrate an upper arm component 1500 having telescoping conduit guides, in that the bent or curved sections 1506 located at the end of the conduit guides 1502 actually extend within the conduit guides 1502 in frictional fit therewith and may pulled out to lengthen the protraction of the curved sections 1506 from cuff 1504 , whereby the point of tensional redirection can be adjusted and positioned as desired along the direction of the axes of the conduit guides. [0052] In the structural design of the upper arm component 1400 , 1500 of FIGS. 14 and 15 , the conduit guides are removably attached to the cuff by spring plate 1408 , which includes curved sides 1410 that receive and retain the conduit guides against the cuff but that may be raised so as to release and remove the conduit guides from the cuff. Furthermore, as shown, a padding component 1412 is adjustably attached to the conduit guides via a second spring plate 1414 . [0053] FIG. 16 illustrates another upper arm component 1600 in accordance with another preferred embodiment thereof. In this embodiment, outriggers 1602 are provided with pulleys 1604 attached at their distal ends. Proximal ends of the outriggers (i.e., the opposite ends thereof) include retention members 1606 for receiving and retaining ends of the elastic cords (not shown for clarity) that are used to connect the upper and lower components together in an orthotic, which elastic cords are engaged and redirected by the pulleys. Outriggers 1602 is secured to the cuff by a mounting member 1608 and the outrigger preferably is adjustable along the axis thereof by sliding frictional engagement through bores formed in mounting member 1608 . A padding component 1610 also is releasably mounted to outriggers 1602 using a spring plate 1612 and, in FIG. 16 , spring plate 1612 and padding component 1610 are actually shown in a disengaged state with padding component 1610 disposed below outriggers 1602 . Padding component 1610 is secured to spring plate 1612 using conventional fasteners, such as screws. [0054] Based on the foregoing description, it will be readily understood by those persons skilled in the art that the present invention is susceptible of broad utility and application. Many embodiments and adaptations of the present invention other than those specifically described herein, as well as many variations, modifications, and equivalent arrangements, will be apparent from or reasonably suggested by the present invention and the foregoing descriptions thereof, without departing from the substance or scope of the present invention. Accordingly, while the present invention has been described herein in detail in relation to one or more preferred embodiments, it is to be understood that this disclosure is only illustrative and exemplary of the present invention and is made merely for the purpose of providing a full and enabling disclosure of the invention. The foregoing disclosure is not intended to be construed to limit the present invention or otherwise exclude any such other embodiments, adaptations, variations, modifications or equivalent arrangements, the present invention being limited only by the claims appended hereto and the equivalents thereof.

1a

FIELD OF INVENTION The present invention relates generally to orthotic braces and more particularly to articulated braces having a joint with adjustable lift assist. BACKGROUND There are many pathologies that can lead to loss of function of the foot and ankle. By way of example, these include stroke, diabetes, Muscular dystrophy, multiple sclerosis and peripheral vascular disease, as well as others. Often the biomechanical deficit will involve loss of dorsiflexion, i.e. the loss of ability to bring the foot up. This situation is generically known as drop foot. The traditional solution is to provide a brace commonly known as an Ankle Foot Orthosis (AFO). The orthosis is commonly made out of one piece of plastic which is trimmed in the back so that it becomes flexible. This design is commonly known in the art as a Posterior Leaf Spring AFO. An improved orthosis is an articulated AFO. This orthosis has an upper portion (calf section) connected to a lower portion (foot section) by a joint. The joint is internally or externally spring loaded so that it picks up the foot. For a spastic patient, a range limiting joint design may be indicated. A range limiting joint limits the patients' ability to push the foot down (plantarflex) beyond a predetermined angle. The articulated design allows a better biomechanical movement of the foot. U.S. Pat. No. 5,826,304 to Carlson describes a composite flexure unit for hingedly joining two relatively movable parts. The unit includes a flexure member comprising a low modulus of elasticity material. The flexure has two mounting portions and a middle connecting portion. The flexure is bendable for pivoting about a rotational axis passing through the middle portion. A load bearing element comprises a high modulus of elasticity material for providing longitudinal strength and stiffness, without significantly increasing flexion stiffness about the rotational axis. An improvement over the Carlson patent is known and marketed under the trade name Tamarak Variable Assist™ Joint, (available from Tamarack Habilitation Technologies, Inc, Blaine, Minn., USA) wherein an adjustable hinge is added to one of the mounting portions, to allow mounting the flexure unit at adjustable angles to a portion of the brace. U.S. Pat. No. 4,665,904 to Lerman discloses a supportive brace includes lateral and medial circular hinges rotatably securing the lateral and medial sides of the leg-supporting shell to the foot supporting shell. The circular hinges are formed by relatively large area wall portions of the shells which overlie each other in the vicinity of the ankle bones projected from the lateral and medial sides of the ankle. It is therefore desired to provide a mechanism of adjustability of the joint characteristics that can easily tailored to individual patient needs such for example by the health care practitioner. Two degrees of adjustability are desired: the angle from which the plantarflexion preloading begins and the moment of force that is created from the preloading. An articulated AFO design that allows this adjustability is biomechanically desired for two important reasons: shock absorption at heel contact and knee stability at heel contact. During ambulation the first part of the step is when the heel hits the ground and the foot plantarflexes to what is generally referred to as footflat. At that first part, it is desirable to adjust the amount of resistance to plantarflexion according to individual needs, as without such resistance there is little to no shock absorption. On the other hand, an excessive resistance to plantarflexion will force the knee forward, resulting in a less stable biomechanical situation. The present invention provides easy adjustability, in an easy to manufacture design, which is cost efficient to manufacture. An orthosis made of two parts presents a problem where, upon sliding the foot into the orthosis, the foot painfully hits, or otherwise gets snagged by, the foot portion. Certain aspects of the present invention aim to resolve this problem. BRIEF DESCRIPTION The present invention provides an articulated AFO or other orthosis, wherein the joint has a combination of a tension element (equivalently called a tensor hereinafter) and an elastic compression element that is being compressed by at least a pair of compression surfaces attached to the foot portion and the calf portion respectively. When applied to any articulating orthosis other than an AFO, the hinged parts of the orthosis are considered the portions equivalent to the calf portion and foot portion. By modifying the dimensions of the compression element, there is provided a field adjustable preloading, i.e. an adjustable angle at no load or light load conditions. Similar effect may be obtained by adjusting the effective length of the tensor. Adjustment of dorsiflexion moment is achieved by modifying the size, shape, or the elastic characteristics of the compression element. The present invention is equally applicable both to custom made and to pre-fabricated braces. By using a flat tensor a ‘foot funnel’ is created that eases donning the brace by providing surfaces that prevent the interference between the foot and the lower part of the brace as described above. Therefore in accordance with a preferred embodiment of the invention, there is provided an articulated orthosis having a first and a second hinged parts, the orthosis having an inner and outer surfaces, and at least one joint for hinging the first and second part. The orthosis comprises a tension element having a first anchor point coupled to the first hinged part and a second anchor point coupled to the second hinged parts, the tension element having at least one flat outer surface which is substantially parallel to the inner surface of the orthosis adjacent to the tension element. Further provided are a first and a second compression surfaces coupled to the first and second parts respectively, with a compression element disposed between the compression surfaces wherein the compression surfaces are located so as to transmit forces to the compression element as a result of angular motion between the first and second hinged parts, the forces being operable to compress the compression element. Preferably, the compression element comprises a first block of resilient material. Also preferably, the flat surface of the tensor is co-planar with the inner surface to provide a better ‘foot funnel’. At an unloaded condition the preload angle between the first and second hinged parts is variable by the dimensions of the compression element. Preferably the tension element has an adjustable effective length, for allowing relative lateral or medial adjustment of the hinged parts, as well as an additional method of controlling the preload angle. The resistance to moment force applied to at least one of the hinged parts is variable by the modulus of elasticity of the compression element. In the preferred embodiment at least one of the hinged parts has a plurality of retaining walls for forming a chamber to at least partially contain the compression element. The tension element (equivalently referred to as a tensor) defines a boundary of the chamber. Most preferably, a part of the chamber is formed in the first hinged part, and another part is formed in the second hinged part, and the compression surfaces comprise a part of the chamber, such as one or more of the walls defining the chamber. Optionally, at least one of said retaining walls is movable for changing the dimensions of the chamber, for allowing field adjustment of the joint characteristics such as pre-load and/or resistance to moment force. Also optionally, at least one of the compression surfaces is adjustable. Optionally, the compression element further comprises a second block of resilient material having a higher modulus of elasticity than the modulus of elasticity of the first block, the second block disposed between at least a portion of the first and second hinged parts, so as to be compressed as result of angular motion therebetween, after compression has been applied to the first block. This results in a ‘stop block’, which limits the relative movement of the hinged parts, while providing a soft rather than an abrupt stop. For ease of manufacturing the tension element preferably comprises anchor points transverse to the flat side. Preferably the tensor has an overall bending stiffness of between 0.035 and 1.3 Nm (Newton meter). More preferably, the tension element has an overall bending stiffness of between 0.08 and 0.9 Nm. Most preferably, the tension element has an overall bending stiffness between 0.2 and 0.5 Nm. An alternative compression element may be selected from a list consisting of a spring, jell cell, pneumatic container, hydraulic cell, or a combination thereof. In another aspect of the present invention there is provided an articulated orthosis having a first and a second hinged parts, the orthosis having an inner and outer surfaces, and at least one joint for hinging the first and second part. The orthosis comprises a first and a second compression surfaces coupled to the first and second parts respectively, and a plurality of retaining walls coupled to at least one of the hinged parts, the walls defining a chamber. Preferably, the compression surfaces are integrated in the chamber. A compression element that is at least partially disposed within the chamber, and a tension element which is at least at least partially disposed within the chamber, the tension element comprises a first anchor point coupled to the first hinged part and a second anchor point coupled to the second hinged parts. The compression surfaces are located so as to transmit forces to the compression element as a result of angular motion between the first and second hinged parts, the forces being operable to compress the compression element. Preferably, the compression element comprises a first block of resilient material, however as in the previous case, it may is selected from a list consisting of a spring, jell cell, pneumatic container, hydraulic cell, or a combination thereof. Optionally, the tension element is retained in place by forces applied by the compression element. Further optionally, the tension element comprises at least one support, which interacts with the compression element to retain the compression element in place. A potential application for the invention is in the design of a wrist hand orthosis. Like the foot, pathologies may make it difficult or painful to extend the wrist in order to raise the hand. The articulated design connects the upper section (forearm section) to the lower section (hand section) in order to provide lift assist to the hand. The range limiting feature may also be desirable for certain treatment options. The skilled in the art will see that the teachings provided herein easily and clearly extend to a wrist hand orthosis. BRIEF DESCRIPTION OF THE DRAWINGS Different aspects of preferred embodiments of the invention will be better understood in view of the accompanying drawings, in which: FIG. 1 is a general depiction of an articulated brace. FIG. 2 depicts a cross section of a preferred embodiment of the joint in an unloaded state. FIG. 3 depicts the joint of FIG. 2 in a compressed, or loaded state. FIG. 4 depicts a rear view of the joint of FIG. 2 . FIG. 5 depicts the front view of the joint of FIG. 2 . FIG. 6 depicts a perspective view of the joint of the previous figures. FIG. 7 depicts a cross section view along cutoff line AA in FIG. 4 . FIG. 8 depicts the joint of FIG. 3 with a motion limiter. FIG. 9 depicts a cross section of the preferred embodiment, showing the tensor in an over-flexed state. FIG. 10 depicts another preferred embodiment of the joint. FIG. 11 shows the alternative design of FIG. 10 as applied to an AFO. FIG. 12 depicts a cross section view along line BB in FIG. 11 . FIG. 13 depicts an alternative tensor construction. FIG. 14 depicts the cross section of the embodiment with an adjustable compression surface. FIG. 15 depicts another embodiment of the invention as it relates to the wrist and hand. DETAILED DESCRIPTION Different aspects of the invention are described in terms of an AFO, which is the preferred embodiment, however it will be clear to the skilled in the art that the invention extends to other orthosis requiring adjustability in pre-loading and moment. Some preferred embodiments are described below. FIG. 1 is a general depiction of an ankle foot brace. A calf section 1 is articulated to a foot section 2 through two joints 3 and 4 respectively. While a single joint brace is also useful, the preferred embodiment calls for utilizing two joints. FIG. 2 depicts a cross section of the preferred embodiment of the invention in an unloaded state. The calf portion 1 and the foot portion 2 of the brace, each have a compression surface 7 and 8 respectively. A tensor 60 is coupled to the calf portion and to the foot portion and holds the portions together. In the preferred embodiment the tensor is coupled using fasteners, such as screws, rivets and the like. The tensor is made of resilient material having relatively high tensile strength in at least one plane. The tensor is sufficiently stiff to resist unwanted over flexion, yet sufficiently flexible to allow for a full range of motion. This effect is achieved by a quality described as overall bending stiffness. Bending Stiffness is described by EI, the product of Young's modulus of elasticity (E) and the second moment of inertia (I). In other words, the bending stiffness of the tensor can be varied by changing the material (thus modulus of elasticity) or the shape (or size) of the cross section of the tensor. The values presented in these specifications for overall bending stiffness are values of bending stiffness (EI) divided by the length of the tensor (L) [overall bending stiffness=EI/L]. The values presented are for tensors with a consistent cross section throughout the length of the tensor. It will be clear to the skilled in the art that equivalent overall bending stiffness may be achieved with an infinite range of various cross sections within the length of the tensor. The preferred embodiment will use tensors having varying cross section to better support the mounting points. As mentioned above, a common problem during donning an AFO is interference between the foot and foot section. A common way of donning the brace involves sliding the foot from the calf section to the foot section. Therefore it is desirable to provide support for the foot as it slides down the brace creating a ‘foot funnel’ to assist in donning. In the preferred embodiment the tensors are located on the inside surface of the brace, and therefore provide a continuity, over which the foot glides as it is being inserted into the brace. It is therefore clear why the preferred embodiment uses a generally flat tensor, mounted with its flat side mounted substantially parallel to the inner surface of the brace, and most preferably coplanar therewith. Thus the tensors of the joint create a “slide” that bridges the gap between the calf section and the foot section. This provides a smooth ‘foot funnel’. It is noted however that other tensor cross sections are also applicable. Placing of the joint posterior superior to the ankle joint further assists in creating such a ‘foot funnel’. Furthermore, the preferred embodiment would comprise one or more of the tensors be an integral part of the calf section, thus providing a smoother ‘foot funnel’ effect. Preferably, the tensor has several anchor points to vary its length and thus the distance between the calf portion and the foot portion. In the preferred embodiment, the tensor is flat, and the anchor points are drilled through the flat side, i.e. the anchor points are transverse to the flat side, therefore allowing easy mounting of the tensor to the foot and calf portions, while crating the ‘foot funnel’ described above. Alternatively, different sizes of tensors may be provided, and/or a plurality of anchor points may be provided in the brace shell. A compression element 20 (equivalently referred to as a bumper in these specifications) is disposed between the two compression surfaces 7 and 8 . The bumper 20 may be held in place by any desired method, such as glue, fastener, strap and the like, but the most preferred embodiment calls for a chamber bounded by side walls and top walls 5 and 15 integral to the brace sections, and the tensor 60 . Such chamber holds the bumper securely and limits the movement of the bumper during both compressed and free states. Most preferably the chamber is formed in two parts, divided between the calf portion and the foot portion, each formed integrally into the respective brace portion. This construction allows for a strong support to the compression surfaces 7 and 8 that constitute one wall of the chamber. The chamber walls may be formed separate from the compression surfaces, and other methods of creating the chamber will also be apparent to the skilled in the art. The compression surfaces are preferably flat, but may take any desired form as long as they are capable of transmitting the plantarflexion moment forces to the bumper. One or more of the compression surfaces may be adjustable as shown for example in FIG. 14 to allow fine tuning of the preload and/or the plantarflexion resistance. Such adjustability may be provided by screws 7 b , cams, ratchets, or any other arrangement that will be known to the skilled in the art for varying the location of a surface 7 a without compromising its load bearing capacity. Preferably, the bumper consists of a piece of flexible material having relatively low modulus of elasticity. The modulus of elasticity is commonly known as ‘durometer number’ after a common instrument to measure the compressibility of the material. Materials such as rubber, silicone, urethane, polyurethane, surlyn™, foam, and the like, are but few examples of suitable bumper material. However alternative bumper construct may be used such as springs, jell cells, pneumatic containers, hydraulic cells, and other implements that provide elastic response to plantarflexion forces. Preferably, the bumper is slightly oversized to the chamber size. Thus the unloaded foot portion of the brace is set at an acute angle to the calf section. The preload angle of the foot and calf sections may be adjusted by selecting bumpers of varying dimensions as regards to size and/or shape. While the bumper may be attached to the brace, compression walls or chamber, it is preferably floating, i.e. freely disposed, within the chamber. The preferred embodiment utilizes a compression fit into one half of the chamber and a looser fit into the other half. The floating bumper allows for inexpensive manufacturing and easy bumper replacement. The tensor attaches the foot and calf portions, and carries the load applied by the foot. As shown in FIG. 3 , during plantarflexion, the compression surfaces transmit the moment force applied by plantarflexion, as forces indicated by vectors Y and Y′, to the bumper. As the bumper has a relatively low modulus of elasticity it allows a certain amount of compression and resists excessive plantarflexion. Thus the modulus of elasticity and the bumper dimensions allow adjustability of the resistance to plantarflexion. FIG. 3 depicts a side view of a joint according to a preferred embodiment during plantarflexion, with the bumper 20 in a compressed state. The bumper is partially enclosed by a chamber formed by pockets in the calf section 1 and in the foot section 2 . As shown in FIGS. 1 and 5 , the tensor 60 defines another boundary, or wall, of the chamber. The skilled in the art will recognize that the tensor is under tension load, while the bumper is under compression load. Therefore the tensor and bumper form a strong joint that provides full range of motion and simultaneously provides resistance to excessive platerflexion. As can be seen in FIG. 1 , the preferred embodiment calls for the tensor to be placed on the interior surface of the brace and for the chamber to be formed in the exterior surface of the brace. FIG. 4 depicts the rear view of the preferred embodiment of the joint, and FIG. 5 provides a view of the front (preferably the one close to the foot). FIG. 5 also shows an optional way to adjust the effective length of the tensor by selecting one of a plurality of mounting holes serving as anchor points. Doing so allows for angular, lateral, or medial adjustment between the foot portion and calf portions. The skilled in the art will recognize that a similar method employing a plurality of mounting in the foot portion, the calf portion, or in both, will achieve equivalent result that is also within the scope of the invention. In both cases, it is preferred that the tensor anchor points are transverse to the flat side of the tensor. Preferably a gap 22 exists between the calf and foot portions. The inner chamber wall is depicted by a dashed line 25 . Fasteners 27 are preferably used to attach the tensor to the foot and calf portions. FIG. 6 is a perspective view of the joint showing the tensor, bumper, and the chambers partially surrounding he bumper. FIG. 7 depicts a cross section of the joint at dashed lines AA in FIG. 4 . In certain cases for an AFO it is desirable to limit the maximum distance that the foot may travel, such as to prevent a drop foot. When one or more of the relatively rigid chamber walls meet, (such as the chamber outer walls 5 and 15 ) further motion is prevented, however such direct contact of the foot and calf portion may result in abrupt stop of the foot motion. FIG. 8 shows an example of a motion limiting arrangement that offers a more gradual motion limit by having the chamber walls 5 and 15 apply force to a stopper 30 having a higher modulus of elasticity, which results in increased resistance to excessive plantarflexion without the jarring motion two rigid parts coming into abrupt contact. Clearly, other placement of the stopper 30 and the respective surfaces applying forces thereto are possible, however the placement of the stopper in the vicinity or within the bumper are preferred as it places the stopper in proximity to the tensors and thus allow better force distribution. FIG. 9 is a cross section of the preferred embodiment, showing how bumpers may be replaced. A notable advantage of the preferred embodiments is the chamber, which allows the bumper to float freely therein, requiring no means of attachment of the bumper to the brace. This advantage eases field adjustability of the brace for the needs of individual patients, by simple replacement of the bumper. In order to replace the bumper, the two portions are angularly rotated about the tensor, creating a sufficiently large opening in the chamber to allow the bumper to be withdrawn. Therefor, in the most preferred embodiment, it is highly desirable to utilize a tensor having high tensile strength along the axis between its mounting points, and sufficiently flexible to allow resilient bending between the foot portion relative to the calf portion, thus allowing easy replacement of the bumper. To best achieve those goals in the present preferred embodiments, the tensor will have an overall bending stiffness in at least one axis, of between 0.035 and 1.3 Nm, where the range between 0.08 and 0.9 Nm is preferred. Presently, it is believed that the ideal range is between 0.2 is 0.5 Nm. In certain cases it is advantageous to place the hinges near ankle. FIG. 10 shows a brace with such placement. Furthermore, the joint depicted in FIG. 10 is of an alternative design, details of which are shown on FIGS. 11 , 12 and 13 . In this embodiment, the bumper and the tensor are both inserted from the inside of the brace. Tensor 60 is inserted inside the chamber, alongside the bumper 20 , as can be seen in FIG. 12 which is a cross section along the lines BB in FIG. 11 . In order to maintain the bumper 20 in position, the tensor in this embodiment is shaped with a bumper holder 90 . The bumper holder may be any protrusion extending to hold the bumper in place, however the preferred embodiment uses fingers that are bent about 90 degrees to the plane of the tensor as seen in FIG. 13 . Optionally, this embodiment offers yet another advantage: if desired, the tensor may have slots 62 cut therein that interact with protrusions (not shown) in the calf and foot portions of the brace, to achieve anchoring. Such arrangement provides easy anchoring of the tensor and the tension forces are transferred to the tensor via the slots. The slots obviate the need for fasteners and therefore reduce the cost of manufacture. Holes 61 are preferably cut into the tensor and engage with matching teeth in the brace to hold the tensor in place. FIG. 15 shows an embodiment of the invention as it may be applied to a wrist hand orthosis. The upper forearm section 12 is hingedly connected to the lower hand section 11 . The skilled in the art will recognize that the operation of the joints as described above between the calf and foot portions will be equivalently applicable to the operation of such joints between the forearm and wrist sections. Therefore while the majority of the description related to the AFO example, the scope of the claims clearly extends to the wrist hand orthosis and other similar orthosis types. It will be appreciated that the invention is not limited to what has been described hereinabove merely by way of example. While there have been described what are at present considered to be the preferred embodiments of this invention, it will be obvious to those skilled in the art that various other embodiments, changes, and modifications may be made therein without departing from the spirit or scope of this invention and that it is, therefore, aimed to cover all such changes and modifications as fall within the true spirit and scope of the invention, for which letters patent is applied.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefits of the Taiwan Patent Application Serial Number 101117892, filed on May 18, 2012, the subject matter of which is incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a fat graft injection device, and particularly to an automatic fat graft injection device which comprises an injection unit, a storage unit, and a pump unit. [0004] 2. Description of Related Art [0005] Autologous fat transplantation technique involves the following steps: the liposuction of an individual's own subcutaneous fat; first to take out autologous fat followed by the extraction and purification of the obtained fat in a sterile condition; and the transplantation by injecting fat grafts to depression or emaciated areas where desired, either congenital or acquired. [0006] In the early period, autologous fat transplantation is not popular became the low fat graft survival and overly high autologous absorptivity due to immaturity of technique and processes. Currently, with the advance of fat graft technique, the tools are also improved correspondingly and with the aid of fat graft survival techniques, autologous fat transplantation is gradually being widely used. [0007] Nevertheless, in the current fat graft, the fat in the syringe is injected into the targeted portion manually. In addition, the fat graft process involves extremely delicate and precise positioning and quantification. Therefore, if the injection dosages are not consistent, excess fat grafts may be overlappingly filled into the targeted area, resulting in unevenness of skin and fat necrosis. Also, when there is a slight error in injection position, the survival of the fat graft may be low, and furthermore, excessive pressure may cause more fat graft necrosis when the pressure is unevenly applied. Thus, a slight mistake may lead to poor blood circulation for the injected fat grafts, thereby causing suppuration, inflammation, or calcification at the affected region. Accordingly, there is an increased risk of surgical failure if all the surgical conditions are solely relied on manual operation. [0008] Therefore, to solve the above-mentioned problems, what is needed in the art is to develop an automatic fat graft injection device to allow fixed orientation, quantification, and constant pressure, thereby increasing survival of fat grafts and relieving considerable physical and mental fatigue of the surgeon during surgery, as well as preventing surgical errors. SUMMARY OF THE INVENTION [0009] An object of the present invention is to provide a fat graft injection device in which a pump unit is used to replace a traditional syringe. The pump unit is automatically controlled to inject the fat graft into the adipose layer in a constant quantity and pressure to maintain the flatness of skin, keeping the fat graft at the right position for access to blood circulation to increase survival. [0010] To achieve these objects, the present invention provides a fat graft injection device, comprising: an injection unit having a connection end and a terminal; a storage unit connected to the injection unit; and a pump unit connected to the storage unit between the injection unit and the pump unit; wherein the storage unit contains fat graft therein, and the fat graft in the storage unit is injected into the adipose layer through the injection unit by the pump unit, thus completing the fat graft injection. [0011] In the fat graft injection device of the present invention, the terminal of the injection unit comprises at least one or more through holes. There may be a plurality of through holes disposed on a single side of the injection unit along a one-dimensional path, and furthermore, there may also be at least one through hole on the tube walls surrounding the terminal of the injection unit, and a through hole disposed on the top of the terminal of the injection unit. In addition, the injection unit is tubular to provide delivery of fat, that means, the fat is introduced into the adipose layer through the injection unit and then via the through holes. Depending on the different positions, the fat amount required for graft may vary. For example, for facial areas, the fat dosage may be usually merely 10 ml to 50 ml, while for breast areas, the fat dosage may be about 50 ml to 500 ml. Thus, the injection unit may be designed with various pipe diameters, different numbers of the through holes, diameters of the through holes, and so on, to cope with the demand for different dosages. [0012] The storage unit of the fat graft injection device according to the present invention is used to store fat grafts obtained from autologous liposuction after a purification process (such as centrifugation). Such fat grafts have fat regenerative capacity. In addition, the storage unit further comprises a case formed of a rigid material to serve as a holding part to protect and cover the storage unit therein. [0013] Furthermore, the storage unit of the fat graft injection device according to the present invention further comprises a storage unit adjusting element to control the flow rate of fat graft by regulating the diameter for fat graft exit in the storage unit. The storage unit adjusting element may be disposed anywhere, as long as convenient for user's operation. The storage unit adjusting element may be in a form of a turning button, a push button, or a push bar, preferably a turning button or a push bar, and more preferably a push button. [0014] Also, the pump unit of the fat graft injection device according to the present invention is used to provide a propulsive force to drive the fat in the storage unit forward into the injection unit. As such, the fat graft is delivered by the injection unit through the holes to a desirable position in the adipose layer. In addition, the pump unit further comprises a pump unit adjusting element to control the operation of the pump unit. With the pump unit adjusting element, the switch of the pump unit can be controlled to thereby, regulate the pressure supplied. An increase in pressure may increase the amount of fat grafts entering the adipose layer, while a decrease in pressure may reduce the amount of fat grafts entering the adipose layer. The pump unit adjusting element may be disposed anywhere, as long as convenient for user's operation, and preferably on the case of the storage unit. The pump unit adjusting element may be in a form of a turning button, a push button, or a push bar, preferably a turning button or a push bar, and more preferably a push button. In addition, the pump unit adjusting element further comprises a control chip which is a voice control chip or a touch control chip to achieve the object of regulating the switch of the pump unit and the pressure supply in a voice or touch manner. Furthermore, the fat graft injection device of the present invention further comprises a microprocessor connected to the storage unit and the pump unit in a wireless or wired manner, to control the operation state of the entire fat graft injection device and regulate the parameters of each component. The microprocessor further comprises a sensing unit which may be a “Navigation system” like device a three-dimensional scanner, an ultrasonic detector, a photosensor, a thermal sensor, a camera, or the like, to provide positioning information. Preferably, a typical three-dimensional scanner and an ultrasonic detector are used to serve as the sensing unit to provide image signals effectively, determine the direction of a designated point and the depth and thickness of an adipose layer, and confirm the site to be injected. [0015] In addition, the fat graft injection device of the present invention may further comprise a power supply unit, wherein the power supply unit may be an external power supply unit which may connect to a power supply through a wire extended from the fat graft injection device. Furthermore, the power supply unit may also be a power supply unit built-in the fat graft injection device, such as a battery. [0016] In the fat graft injection device according to the present invention, a robotic arm connected to the storage unit is further comprised to rotate and move the injection cannula unit multidirectionally. The fat graft injection device employs a robotic arm to replace manual effort of the surgeon during surgery to decrease the load of the surgeon. The robotic arm of the present invention controls the manner of movement and rotation of injection cannula unit. Thereby, the robotic arm may also adjust the operation process of direction alteration, movement, and rotation with the coordination of the navigation system. [0017] In the fat graft injection device of the present invention, a servo motor is further included as a controller for the fat injection to control a switch unit (such as an automatic valve, a revolvers, a rotatable disk, or the like) which is connected and controls the injection unit to inject fat in a form of successive batch. Such a servo motor connected to a computer and acts following the instruction from the computer program. Alternatively, the servo motor self may serve as a dispenser to control the injection in a form of successive batch. [0018] In an embodiment, the navigation system according to the present invention may include a camera, a wireless unit (e.g. radio frequency or blue tooth), or a processor to position the probes more precisely, and then a series of electrical signals may be obtained by the camera, processed by the processor, and transmitted through the wireless unit. Such that, the area and depth for fat injection thus be defined, and then the robotic system with particular size and the number of the side hole may be calculated and planed by using the series of electrical signals to do fat injection. [0019] Before the surgery is performed, fat position should be investigated with a computer tomography (CT) system or a 3-Dimentional digital camera to determine the area for fat injection. After characteristics of the internal structure of an object such as dimensions, shape, internal defects, and density are readily available from CT images, or appearance images obtained from the camera, these obtained images are processed by a computer programming for 3D image modeling, and 3D surface topology. The robotic arm automatically moves to the specific position in 3 directions: latitudinal direction, longitudinal direction, and transverse direction (horizontal direction) according to the obtained 3D surface topology of a computer programming. [0020] In addition, the automatic fat graft injection device according to the present invention may be operated combining with a robotic system to further overcome the limitations of traditional fat grafting surgery and improve the effectiveness and accuracy. [0021] In the present invention, according to the obtained 3 D surface topology of a computer programming and the obtained area, the thickness and the volume, multiple layers, number of incisional sites, positions of injection routes, moving speeds of an injection unit in the adipose layer, and quantity/time for the fat injection surgery can be calculated automatically by computer programming. In result, the fat injection using the automatic fat graft injection device of the present invention is automatically performed in the form of stratification with a specific multiple layers, number of incisional sites, injection routes, moving speeds of an injection unit in the adipose layer, and quantity/time by computer programming, wherein the fat injection at each of the incisional site in the same layer may distribute evenly and smoothly, and achieve the predictive goals. [0022] In summary, the present invention provides an automatic fat graft injection device including a pump unit and a storage unit used to store fat, wherein a navigation system (such as a three-dimensional scanner and an ultrasonic detector) of a microprocessor is used to detect the adipose layer and to inject fat graft to the recipient site in need little by little in a one-dimensional direction in multiple lines, multiple layers. Also, the fat graft amount and the pressure of each injection can be automatically controlled by the pump unit to achieve the object of precise and uniform fat graft, thereby maintaining the higher survival rate, flatness of skin and reducing manual efforts. BRIEF DESCRIPTION OF THE DRAWINGS [0023] The above and other objects, features and other advantages of the present invention will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings, in which: [0024] FIG. 1 shows a schematic view of the fat graft injection device contains of injection unit, control panel, storage unit of Embodiment 1 according to the present invention. The fat graft injection device of this embodiment comprises an injection unit 1 , a storage unit 2 , a pump unit 3 , a computer 4 with a detector 42 , a robotic arm 5 , a servo motor 6 , an operation table fixation 7 , and a power supply unit (not shown), wherein the injection unit 1 is tubular and has a connection end 11 and a terminal 12 . [0025] FIGS. 2A-2C shows a schematic view of the injection unit may have different sizes and distributed of side holes. Embodiment 1 according to the present invention, wherein the terminal 12 may be cylindrical or beak-like and may have one or more side holes 121 through which the fat graft can be injected into the adipose layer. [0026] FIG. 3 shows a schematic view of the fat graft injection device with a navigation system of Embodiment 2 according to the present invention. A navigation system can be added to adjust the recipient site area and depth for fat graft injection. The fat graft injection device is substantially the same as Embodiment 1, an except navigation system that this embodiment further comprises a microprocessor 4 connected to the storage unit 2 and the pump unit 3 in a wireless or wired manner to transmit signals with each other, to control and show each parameter in the fat graft injection device of this embodiment. [0027] FIG. 4 shows a schematic view of the fat graft injection device of Embodiment 3 according to the present invention. The fat graft injection device is substantially the same as Embodiment 2, except that the pump unit control panel of the this embodiment is a control chip 33 for regulating the operation of the pump unit 3 in a touch manner. [0028] FIG. 5A shows a schematic view of the fat graft injection device of Embodiment 4 according to the present invention. [0029] FIG. 5B shows an enlarged schematic view of the storage unit adjusting element of Embodiment 4 according to the present invention. The fat graft injection device is substantially the same as Embodiment 2, except that this embodiment uses a storage unit adjusting element 22 to control the flow rate of fat graft, in a manner of rotating a gear 221 by a turning button (not shown) to drive the rack rail 222 ′ on a partition 222 mechanically, thereby pressing down or lifting up the partition 222 to regulate the exit diameter of the storage unit adjusting element 22 to the injection unit 1 to control the fat graft amount of each injection. [0030] FIG. 6 shows a schematic view of the fat graft injection device of Embodiment 5 according to the present invention. The fat graft injection device is substantially the same as Embodiment 1, except that the electric power source of this embodiment is a battery 43 , and thus, this embodiment has the same portability with a syringe of the traditional fat graft injection device, but surpasses the traditional syringe with its automation. [0031] FIG. 7A shows a schematic view of positioning and layout of the site for fat injection. Before the surgery is performed, the area for fat graft injection should be disinfected, and then a positioning needles for measuring the x, y plane is inserted at this area. The positioning needles inserted at the X mark to determine the area for fat graft injection, and the insertion depth is set by a microprocessor unit, wherein the positioning needle is further installed with at least one sensor connected to the microprocessor unit to transmit signals with each other. [0032] FIG. 7B shows an enlarged schematic view of the site for fat injection. Four positioning needles 80 are inserted at the area, which fat graft through the dermal layer 91 to the adipose layer 92 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0033] In the following description, numerous specific details are set forth to provide a thorough understanding of embodiments of the present disclosure. However, one having an ordinary skill in the art will recognize that embodiments of the disclosure can be practiced without these specific details. [0034] Observation of Fat Position [0035] Before the surgery is performed, the recipient site should be accessed with a computer tomography (CT) system or a 3-Dimantional digital camera to determine the area for fat injection. Computer tomography (CT) is a powerful nondestructive evaluation technique for producing 2-D and 3-D cross-sectional images of an object from flat X-ray images. After characteristics of the internal structure of an object such as dimensions, shape, internal defects, and density are readily available from CT images, or appearance images obtained from the 3-D camera, these obtained images are processed by a computer programming for 3D image modeling, or 3D surface topology. The robotic arm 5 automatically moves to the specific position in 3 directions: latitudinal direction, longitudinal direction, and transverse direction (horizontal direction) according to the obtained 3D surface topology of a computer programming. Embodiment 1 [0036] Referring to FIG. 1 , which shows a schematic view of the fat graft injection device of Embodiment 1 according to the present invention. The fat graft injection device of this embodiment comprises an injection unit 1 , a storage unit 2 , a pump unit 3 , a computer 4 with a detector 42 , a robotic arm 5 , a servo motor 6 , an operation table fixation 7 , and a power supply unit (not shown), wherein the injection unit 1 is tubular and has a connection end 11 and a terminal 12 . As shown in FIGS. 2A-2C , the terminal 12 may be cylindrical or beak-like and may have one or more side holes 121 through which the fat graft can be injected into the adipose layer. In addition, the storage unit 2 connected to the injection unit 1 is used to store fat grafts obtained from the purified autologous fat graft. Also, the storage unit may further comprise a case 21 formed of a rigid material to serve as a holding part of the fat graft injection device according to the present invention to protect and cover the storage unit 2 therein. [0037] The pump unit 3 is connected to the storage unit 2 via a pipeline 31 , and the storage unit 2 is disposed between the injection unit 1 and the pump unit 2 , wherein the pipeline 31 is used to provide a propulsive force to drive the fat graft in the storage unit 2 into the injection unit 1 . As such, the fat graft is delivered by the injection unit 1 through the side holes 121 to a desirable area in the adipose layer. In addition, the storage unit 3 further comprises a pump unit control panel 32 disposed on the case 21 of the storage unit 2 in a form of a combination of buttons comprising a switch button, a pressure increase button, and a pressure decrease button, to control the operation of the pump unit 3 . The switch button of the control panel 32 can turn on the pump unit 3 in a pulse manner to provide a positive pressure to inject the fat grafts from the storage unit 2 into the adipose layer through the injection unit 1 . Also, the applied pressure can be regulated by the pressure increase button and the pressure decrease button, and an increase in pressure may increase the amount of fat grafts entering the adipose layer, while a decrease in pressure may reduce the amount of fat grafts entering the adipose layer. However, the storage unit 2 and the pump unit 3 can be connected by an electrical connection (not shown), to control the signal transmission therebetween. Also, the storage unit 2 of this embodiment is connected to a power line 41 extending to the power supply unit (not shown) to provide electric power source of this embodiment. [0038] In this Embodiment, the robotic arm 5 is connected to the injection unit 1 to rotate and move the storage unit 2 , line by line, layer by layer according to X, Y axis. The robotic arm replaces manual operation and can adjust the position and angle of the storage unit 2 , thereby adjusting the positions and angles of the navigation system. [0039] In the fat graft injection device of this embodiment, a servo motor 6 is further included as a controller for the fat injection to control an automatic valve (not shown), which is connected and controls the injection unit to inject fat in a form of successive batch. Such a servo motor connected to a computer and acts following the instruction from the computer program. Embodiment 2 [0040] Referring to FIG. 3 , which shows a schematic view of the fat graft injection device of Embodiment 2 according to the present invention. The fat graft injection device is substantially the same as Embodiment 1, an except navigation system that this embodiment further comprises a microprocessor 4 connected to the storage unit 2 and the pump unit 3 in a wireless or wired manner to transmit signals with each other, to control and show each parameter in the fat graft injection device of this embodiment. The microprocessor 4 also connects to the computer. Furthermore, the microprocessor 4 further comprises a sensing unit 42 which may be a three-dimensional scanner for positioning and confirming the depth and thickness of an adipose layer, and transmitting image signals to be processed by the microprocessor 4 , thereby providing information of the designated position for a surgeon to determine the position of fat grafting. Embodiment 3 [0041] Referring to FIG. 4 , which shows a schematic view of the fat graft injection device of Embodiment 3 according to the present invention. The fat graft injection device is substantially the same as Embodiment 2, except that the pump unit control panel of the this embodiment is a control chip 33 for regulating the operation of the pump unit 3 in a touch manner. Embodiment 4 [0042] Referring to FIG. 5A , which shows a schematic view of the fat graft injection device of Embodiment 4 according to the present invention. The fat graft injection device is substantially the same as Embodiment 2, except that this embodiment uses a storage unit adjusting element 22 to control the flow rate of fat graft, in a manner of rotating a gear 221 by a turning button (not shown) to drive the rack rail 222 ′ on a partition 222 (as shown in FIG. 5B ) mechanically, thereby pressing down or lifting up the partition 222 to regulate the exit diameter of the storage unit adjusting element 22 to the injection unit 1 to control the fat graft amount of each injection. However, the turning button adjusting element may also control the operation of a mechanical adjusting element according to the parameters set by the microprocessor 4 . Embodiment 5 [0043] Referring to FIG. 6 , which shows a schematic view of the fat graft injection device of Embodiment 5 according to the present invention. The fat graft injection device is substantially the same as Embodiment 1, except that the electric power source of this embodiment is a battery 43 , and thus, this embodiment has the same portability with a syringe of the traditional fat graft injection device, but surpasses the traditional syringe with its automation. [0044] In summary, according to the above embodiments of the present invention, the fat grafts in the storage unit are injected into the adipose layer through the injection unit by the pump unit, and the fat graft injection is performed with a syringe pushed in an automatic manner instead of manual operation. In addition, with the microprocessor, the conditions of the surgery process can be fine-tuned, to achieve a fat graft injection with multiple lines, multiple layers, equally distributed, quantification, and constant pressure, thereby increasing survival of fat grafts and relieving considerable physical and mental fatigue of the surgeon during surgery. Operation Embodiment 1: Positioning of the Area and Thickness of the Recipient Site (x, y, z Axis) Before Fat Injection [0045] Before the surgery is performed, the site for fat graft injection should be disinfected, and then a positioning needle for measuring the x, y plane is inserted at this site, as shown in FIG. 7A . The following steps were comprised: 1. Insert the positioning needles (probes) to definite the area and depth of fat injection; 2. Navigation system is used to start to scan the surface of area defined for the volume and area of fat injection; 3. Micro processer (chip) calculate and make a plan for fat injection, such as area, depth, volume, speed, and required time; 4. Choose injection unit (large or small diameter with different side holes); 5. Set up the robotic system; 6. Action. The positioning needles inserted at the X mark to determine the area for fat graft injection, and the insertion depth is set by a microprocessor unit (such as a computer), wherein the positioning needle is further installed with at least one sensor connected to the microprocessor unit to transmit signals with each other. For example, referring to FIG. 7B , four positioning needles 80 are inserted at the site graft through the dermal layer 91 to the adipose layer 92 . Each of the positioning needles 80 has a first positioning sensor 801 and a second positioning sensor 802 , wherein a height H between the first positioning sensor 801 and the second positioning sensor 802 may be adjusted depending on the different thicknesses of the tissue. The first positioning sensor 801 is disposed between the dermal layer 91 and the adipose layer 92 , and the second positioning needle sensor 802 is disposed in the space between the adipose layer 92 and the muscle layer 93 . Thus, the fat graft injection device will not migrate to the muscle layer. The positioning needles 80 are used not only to determine the area for the fat graft injection, but also to decide the depth (z axis) for the fat graft injection, as well as to provide a stereotactic positioning function, to achieve automatic fat graft injection. In addition, the sensors and the guiding unit of the present invention transmit signals with each other, and the sensors may also scan the depth for fat graft injection automatically and provide instructions of the area for fat injection. Then, the x. y. and z axes are determined at the site for fat graft injection (as shown in FIG. 7B ), wherein [x×y] is the area for fat graft injection, z is the depth of the fat. In addition, the distance between the four positioning needles is divided into “m” equal parts in x axis, “n” equal parts in y axis, and “k” equal parts in z axis, to lay out a grid pattern, i.e. a m×n grid pattern, in the xy plane for fat injection. “m” is using the unit of centimeter such 6 cm, m=6. Thus, the fat amount and direction for fat injection are easy to control and well distributed. Such a positioning system can be used to estimate the area (m×n), the thickness (k−1) and the volume [m×n×(k−1)], as well as the processing time for fat injection, wherein (k−1) is the thickness of the adipose layer excluding the thickness (z-axis) of the dermal layer. The reason for z-axis amount “k−1” is for preserving 1 cm away from the skin to avoid penetrating or uneven skin surface. Therefore, after the fat injection of a predetermined plane (as shown in FIG. 7B : x 1 , y 1 ) is completed, another plane for fat injection (x 2 , y 2 ) located at a shallower position is subsequently performed, in a manner of from deep to superficial planes along the z-axis. Therefore, the flatness of skin can be maintained after the fat injection surgery. [0046] In the present invention, according to the obtained 3D surface topology of a computer programming and the obtained area (m×n cm 2 ), the thickness (k−1 cm) and the volume [m×n×(k−1) cm 3 ], multiple layers of stratification, a incisional site number and position, a moving speed of an injection unit 1 in the subcutaneous layer, and a quantity/time for the fat graft injection surgery can be calculated automatically by computer programming. In result, the fat injection using the automatic fat graft injection device of the present invention is automatically performed in the form of stratification with a specific layer numbers, numbers of incisional sites, injection route, a moving speed of an injection unit 1 in the adipose layer, and quantity/time by computer programming, wherein the fat injection at each of the subcutaneous layer may distribute evenly and smoothly, and achieve the predictive goals. [0047] Although the present invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as hereinafter claimed.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This is a continuation under 37 CFR 1.53(b) of pending prior application Ser. No. 11/244,114 filed Oct. 5, 2005 and claims the benefit of priority under 35 U.S.C. §119 of German Application DE 10 2004 050 981.6 filed Oct. 20, 2004. The entire contents of each of the applications is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention pertains to an electrode belt for carrying out electrodiagnostic procedures on the human body. BACKGROUND OF THE INVENTION [0003] It has been known for a long time that electric signals, which are obtained via electrodes applied to the body, can be evaluated in connection with various diagnostic procedures. The application of electrodes on the body surface, which is necessary for this, must guarantee primarily reliability and stability of position. Large contact areas are used, in general, for obtaining signals in a reliable manner in order to ensure good electric contact. [0004] Two basic principles have become widespread, in principle, for attaching the electrodes. Electrodes are either attached to the body surface as individually adhering electrodes, or the electrodes are attached to a carrier means, which ensures the reliable seating of the electrodes in the desired positions. Numerous different carrier means have been known for such an attaching of electrodes. General requirements, which are also to be imposed on other devices that are intended for use in the field of medicine, are imposed, as a rule, on these [carrier means]. These may include a design as a reusable product and, associated herewith, good suitability for easy cleaning or disinfection or sterilization. Furthermore, low production costs are always sought to be achieved: Besides, the possibility of rapidly arranging such a carrier means even on recumbent or unconscious patients, which must possibly be possible by a single care person, is to be provided. [0005] Furthermore, requirements that ensure the acceptance of the particular carrier means and of the diagnostic procedure that can be embodied therewith are to be taken into consideration. Forms of geometric design, i.e., for example, a flat design, which limit the particular patient's mobility only slightly at best, are therefore desired. A stretching behavior, which can be metered in a pleasant manner and is not felt to be disturbing, a surface quality that does not lead to discomfort on the part of the patient, as well as a pleasant wear behavior even in case of long-term applications are desirable in case of elastic devices. Particular attention should be paid, besides, to efforts to find embodiments that lead to a minimal formation of necroses at best during long-term applications. [0006] Various forms of belts have proved to be particularly successful as carrier means for diagnostic procedures in which electrodes must be arranged essentially in one plane around a patient's body or only individual electrodes must be attached to the body. [0007] The electroimpedance tomography procedure is such a procedure, which requires the arrangement of a plurality of electrodes essentially in one plane around the body of a patient. Electroimpedance tomography is a procedure in which the electric alternating current impedance between the feed point and the measurement point can be calculated by feeding an electric alternating current into the human body and measuring the resulting surface potentials at different points of the body. A two-dimensional tomogram of the electric impedance distribution in the body being examined can be determined by means of suitable mathematical reconstruction algorithms with different combinations of the feed site and measurement site, for example, by successive rotation of the position of the current feed around the body while measuring the surface potentials at the same time along a section plane. [0008] A tomogram of the impedance distribution of the human body is of interest in medicine, because the electric impedance changes with both the air content and the content of extracellular fluids in the tissue. Thus, both ventilation, especially the distribution of air-filled cavities, and perfusion can be visualized and monitored within the section plane in a regionally resolved manner. This is of significance especially in examinations of the thorax. [0009] Since electroimpedance tomography imposes relatively high requirements on the application of the electrodes, the present invention shall be explained below as an example on the basis of this procedure even though the technical teaching can be extrapolated without problems to other electrodiagnostic procedures as well. [0010] The reliable and rapid connection of the electrodes to recumbent patients as well as a permanently good contact between the skin and the individual electrodes are of crucial significance for the clinical acceptance of the electroimpedance tomography procedure. The use of standard electrodes, i.e., for example, commercially available ECG electrodes, belongs to the state of the art. These are frequently connected to individually extending electrode cables. To suppress electric interferences and strong inductive disturbance, these electrodes are connected to the electroimpedance tomography apparatus in some cases via shielded lines. This shielding can be operated actively in some cases. Since electroimpedance tomography is a procedure in which signals fed in are needed that must be known accurately in order to make possible the meaningful evaluation of received signals, this procedure inherently has an especially high susceptibility to coupled interferences. [0011] Various processes have been known for reducing such interferences by means of specific filter algorithms or for minimizing them by corresponding calibrations concerning their effect. However, since individual cables may also interfere with one another, a relative stability of the positions of the individual cables in relation to one another is absolutely necessary for such a calibration. This requirement can be met for a large number of cables at considerable effort only. A larger number of individually extending cables is, moreover, less comfortable for the patient as well as the medical staff. To guarantee low susceptibility to errors, overstressing of these lines is to be avoided in connection with the use of electric lines. In particular, kinking and strong tensile loads are to be avoided. [0012] Numerous approaches to partially master these problems have been known from the state of the art. [0013] It is known from a device of this class that a plurality of electrodes can be arranged at a support structure and they can be actuated and polled through individual lines, which lead to a multipole cable. However, this device is suitable preferably for performing ECG examinations. This device is susceptible to interferences in case of application in the area of electroimpedance tomography, because the individual lines lack sufficiently stable positions (WO 97/14346). [0014] Furthermore, it is known that a plurality of electrodes can be cast in one piece with a belt. However, this sometimes causes the manufacturer to face considerable difficulties and reduces the subsequent possibility of adaptability of such a belt system to special requirements (WO 03/082103 A1). [0015] Furthermore, it is known that a plurality of electrodes can be arranged on an elastic band. However, such a solution possibly offers an excessively low level of safety concerning the stability of position of the electrodes under various conditions of use (DE 196 10 246 A1). [0016] Furthermore, it is known that the susceptibility to interferences of a described device with a plurality of electrodes can be reduced by special driver circuits. However, this causes a rather substantial increase in the technical effort and offers only conditional safety against the effects of various coupled interferences (DE 101 56 833 A1). [0017] Furthermore, it is known that the meaningfulness of images obtained by electroimpedance tomography can be increased by superimposing to these images other images that were obtained by other physical diagnostic procedures. However, this considerably increases the technologically necessary effort (EP 1000580 A1). SUMMARY OF THE INVENTION [0018] The object of the present invention is to provide an electrode belt that extensively avoids the above-described drawbacks of the state of the art and is, in particular, well suited for use in the area of electroimpedance tomography. [0019] The present invention is embodied by an electrode belt for carrying out electrodiagnostic procedures on the human body. This electrode belt comprises a belt, which consists at least partially of an elastic material and surrounds the body of a test subject, and a plurality of electrodes, which are mechanically connected to the belt and are in flat contact with the body of a test subject, wherein at least one contact means passes through the belt from the electrodes and is connected to a connection element, which is connected to a respective lead of a multicore cable. The contact means is designed for this purpose as a conductive connection between the electrode surface and the connection element, it is firmly connected in an advantageous embodiment to the electrode and has a sufficient thickness to hold, as a support means, the connection element in its position. [0020] It is advantageous if each lead of the multicore cable has a separate shielding. [0021] The embodiment in which the leads are led within a multicore cable guarantees nearly constant position of the individual leads in relation to one another. The effects of different interferences can be effectively reduced in connection with the separate shielding of each lead. Such a multicore cable may be defined as a cable tree comprising a plurality of individually shielded cables, which is characterized by especially good positional stability of the individual cables in relation to one another and by especially easy handling. [0022] An advantageous applicability of an electrode belt according to the present invention can be embodied if the contact means connected with the electrodes are detachably connected to the connection elements, which are connected to a lead each of the multicore cable. The complete cable structure including the connection elements can thus be separated from the electrode belt without having to remove the electrodes from the support structure of the belt. It is particularly advantageous for such an embodiment if each electrode has a rigid contact pin each, which is passed through the belt and protrudes from the belt on the side of the belt facing away from the body. This contact pin is preferably connected detachably with a corresponding connection element. The connection is advantageously carried out in the manner of a pushbutton connection. For example, the contact pins of the electrodes may have for this purpose a spherical closure on the side facing away from the body. The connection elements, which are connected to a lead each of the multicore cable, have, in their turn, spring elements, which make it possible to reach behind the spherical closure of the contact pins. The pushbutton connection can thus be brought about by simply pressing the connection elements on the contact pin and pulling them off the contact pin, or it can be supported by unlocking aids contained in the connection elements. For example, cable systems as described in US 2004/0105245 A1 may be used for this embodiment. Highly reliable results were thus obtained in a signal feed frequency range of 50-200 kHz. Very low interference levels can be reached by means of a cabling arranged in this manner with separate shielding of the individual leads. The inductive disturbance between the leads is, moreover, well compensated; handling is very user-friendly, and movement artifacts due to changes in the distance between individual leads are reduced as well. The possibility of separating the belt and the cable from one another is advantageous for cleaning operations which become necessary in the course of everyday use. [0023] It is particularly advantageous for increasing wearing comfort if the electrodes have a planar surface, which is in flat contact with the test subject's body and the edge of the electrodes ends approximately flush with the belt surface lying on the body. An especially high reliability of contact is obtained if the electrodes have a convex surface, which is in flat contact with the test subject's body and the edge of the electrodes ends approximately flush with the belt surface lying on the body. Due to the elevation of the convex surface, there will be an especially close contact between the electrode and the surface of the body at least in the middle area of the electrode surface. [0024] Moreover, it is advantageous especially for long-term applications if only mild skin irritations occur at best at the edges of the belt. One problem arises due to the fact that such electrode belts are frequently used in relatively obese patients. The pressing pressure of the belt that is necessary for a reliable electric contact may possibly cause the belt to cut relatively deeply into the skin. To nevertheless prevent skin irritations at the edges of the belt even during long-term wear, it is advantageous if the thickness of the belt material decreases toward the edges. Easier deformability of the edges of the belt is achieved as a result, which prevents the skin from overlapping in this area because the belt can adapt itself better to the shape of the skin and a sharp-edged termination cannot occur. Skin irritations in the edge area of the electrode belt can be prevented from occurring especially effectively if the edges of the belt are designed as a hose-like bead. As a result, the skin cannot form folds, which would have edges that would touch each other, even if the belt penetrates relatively deeply into the patient's skin, but it can gather only around areas of the hose-like bead. It was found that such an embodiment of the belt contributes to the effective prevention of necroses even during long-term applications. [0025] To guarantee protection of the cables from excessive pull, it is advantageous if the distance between adjacent electrodes in the relaxed state is shorter than the length of the multicore cable between the corresponding adjacent connection elements and the multicore cable has a meandering course extending approximately in parallel to the body surface. It proved to be especially advantageous if the cable is approx. 30% longer than the belt in the relaxed state. If the elastic belt is stretched, only the length of the belt will change, but the length of the cable will remain constant, and the meander structure, in which the cable is led, will be flattened, instead. Thus, in case of a 30% longer cable, stretching of the belt by 30% can be achieved without the tensile load on the cable changing. This acts as a securing against overload when the belt is stretched to the full length of the cable. It is especially advantageous for a meandering cable pattern if the connection elements are connected to the contact means of the electrodes such that they can be rotated about an axis in parallel to the normal line to the body surface in the area of the flat contact of the electrodes. This makes it possible to firmly clamp the cable in the connection elements. Kinking of the cables under different tensile loads is thus completely prevented from occurring. Long-term stable use without a necessary change of cable is thus ensured. The quality of the signals is essentially maintained because sensitive kinks are prevented from forming in the cable. [0026] It is especially advantageous if the belt and/or the electrodes consist of a material that can be disinfected and sterilized without being damaged. Silicone as the belt and/or electrode material is provided for this purpose in an advantageous embodiment. Moreover, it is advantageous for maintaining the contact properties if the electrodes consist at least partially of a conductive plastic or a plastic coated with a conductive material. In an alternative advantageous embodiment, the electrodes consist partially of stainless steel or sintered silver chloride. [0027] An especially high reliability of the electrode contact and electrode position is obtained if at least individual electrodes have adhesive gel pads on one side. To facilitate the placement of an electrode belt according to the present invention, it is advantageous if the electrode belt can be opened at least at one point. It is especially advantageous if the belt comprises a plurality of individual segments that can be connected with one another and each of these individual segments is connected with at least four electrodes. These four electrodes each are advantageously connected to connection means that are connected to different, individually shielded leads of a multicore cable each. The individual segments with the electrodes and the cable can thus be separated from one another in the completely mounted state and can be individually replaced or put on one after another. [0028] It is advantageous in connection with the use of the electrode belt according to the present invention in the area of the chest if tensioning means, which ensure the firm seating of individual electrodes in concave areas of the body surface, are additionally present. These tensioning means may be designed such that at least one gel pad is present, which makes it possible to support the electrodes at a tensioning means arranged at a spaced location in front of the body, for example, at a belt. [0029] An especially effective shielding against interferences can be achieved if the individual leads of the multicore cable are doubly shielded. In another, especially effective embodiment, the individual leads of the multicore cable have an individual shielding each and are additionally surrounded as a whole by a second, common shielding. Individual shieldings or all shieldings may be driven actively or act passively. [0030] An especially high reliability of operation can be achieved if the connection between the belt and the connection elements is designed such that liquids are prevented from penetrating into the area in which the electric contact is established or the penetration of liquids is at least made difficult. This can be achieved, for example, by molding seals on the belt, which engage a groove in the body of the individual connection elements in a positive-locking manner. [0031] The present invention will be explained in greater detail on the basis of an exemplary embodiment. [0032] 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 specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which preferred embodiments of the invention are illustrated. BRIEF DESCRIPTION OF THE DRAWINGS [0033] In the drawings: [0034] FIG. 1 is a sectional view of an electrode belt according to the present invention with electrodes with a planar contact surface; [0035] FIG. 2 is a sectional view of an electrode belt according to the present invention with electrodes with a convex contact surface; [0036] FIG. 3 is a schematic overall view of an electrode belt according to the present invention; [0037] FIG. 4 is the view of an electrode belt according to the present invention in the relaxed state; [0038] FIG. 5 is the view of an electrode belt according to the present invention in the tensioned state; [0039] FIG. 6 is a sectional view of an especially advantageous belt shape; [0040] FIG. 7 is a schematic view of an electrode belt according to the present invention with a gel pad for supporting the electrodes in the area of the sternum; [0041] FIG. 8 is a schematic view of a connection element with an electrode attached thereto; and [0042] FIG. 9 is a schematic view of a connection element with an electrode attached thereto, wherein the area of the electric contact is secured against the penetration of liquids. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0043] Referring to the drawings in particular, FIG. 1 shows, in a sectional view of an electrode belt according to the present invention, how an electrode 1 is integrated in an elastic belt 2 . The electrode 1 has a planar contact surface 3 . This ends flush with the belt 2 , so that a uniform, flat surface is formed on the patient's body. A contact pin 4 passes through the belt 2 , protrudes from the belt 2 on the side facing away from the body, and has a spherical closure 5 . This spherical closure 5 can be introduced into a corresponding connection element according to the pushbutton principle. Attaching of the connection elements, in which the connection elements are mounted rotatably about an axis at right angles to the electrode surface, even though they are fixed in a position, can be achieved by means of this pushbutton connection in an especially simple manner. The thickness of the belt material decreases from the center toward the edge, which leads to increased wear comfort. As a whole, this embodiment makes possible a very flat design. [0044] FIG. 2 shows a similar design according to the present invention with an electrode 1 , which has a convex contact surface 3 ′. As a result, the contact surface 3 ′ slightly projects from the belt 2 , which ensures an especially effective contact with the patient's skin. In addition, the entire contact surface 3 ′ projects slightly over the belt material. This projection is dimensioned such that the skin will not be damaged and there will be no loss of wear comfort. The edge areas of the belt 2 , which end flat, ensure even in case of highly obese patients and relatively strong pressing pressures that there will be no skin irritation at the edge of the belt when the belt cuts into the skin. The flatly tapering areas of the belt possibly fit the shape of any possible skin fold. [0045] FIG. 3 shows a schematic overall view of an electrode belt according to the present invention, which surrounds a patient's upper body. This comprises a belt 2 made of a stretchable biocompatible material, such as silicone, which has a good stretching behavior in case of a slight increase in force and represents hardly any allergenic burden. The electrode belt also comprises in this case 16 firmly integrated electrodes 1 - 1 through 1 - 16 made of silicone, which are connected to a cable tree by means of a pushbutton connection on the rear side of the belt. This cable tree comprises essentially one or more multicore cables, whose individual leads are shielded individually. In this exemplary embodiment, the device contains two electrode groups with eight electrodes each, which are supplied with corresponding cable connections from two directions, wherein four electrodes each are connected via connection elements to a respective common cable 6 , 6 ′, 6 ″, 6 ′″. The electrode belt may be advantageously separated at a connection element 7 at intermediate points between the electrode groups, here between the electrodes 1 - 1 and 1 - 16 , in order to facilitate the application. Besides the fixed integration of the electrodes into the belt material, a detachable connection is possible between the electrodes and the belt in another advantageous embodiment, for example, by plugging the electrodes into a belt provided with prepared openings. As a result, especially simple cleaning and disinfection can be achieved and the entire electrode belt can be adapted to changed requirements. Due to the elasticity of the belt material, a pressure that depends on the circumference of the thorax and the length of the belt is applied to the electrodes. The four multicore cables 6 , 6 ′, 6 ″, 6 ′″ are led in pairs, on the side of the patient, to a plug type connection 8 located near the patient, to which a reference electrode 9 and a connection cable 10 for connection to an electrode belt are connected. [0046] FIG. 4 shows the side of a half of an electrode belt shown in FIG. 3 , which side faces away from the body. The eight electrodes are supplied by two multicore cables 6 , 6 ′, four electrodes each being connected via connection elements 11 - 1 through 11 - 4 and 11 - 5 through 11 - 8 to one and the same multicore cable and the connection elements being each connected to another, individually shielded lead. The belt 2 is in the relaxed state. The length of the multicore cable is approximately 30% greater than the length of the carrying belt 2 in the relaxed state. The connection elements 11 - 1 through 11 - 8 are mounted rotatably and have an orientation that enables the multicore cables to have a kink-free, meandering course. [0047] FIG. 5 shows the same detail of an electrode belt according to the present invention in the state in which it is overstretched by 30%. The belt 2 and the multicore cable 6 , 6 ′ are approximately parallel in this situation. The rotatably mounted connection elements 11 - 1 through 11 - 8 are pivoted into a position that makes possible the kink-free, parallel course of the cable in front of the belt. In addition, a strain relief integrated in the multicore cable becomes effective in case of this overstretching. A further stretching is not possible, because the multicore cable connected to the belt via the connection elements and the electrodes acts as a stop. [0048] The use of a multicore cable, in which each lead is shielded individually, offers technological advantages. Such cables can be manufactured as cut goods and are cut at the particular necessary points only in case of applications to an electrode belt according to the present invention, and only the lead that is to be connected to the corresponding connection element is actually cut electrically in case of such a cutting, while the other remaining leads extend past the connection point without damage to the shielding or the core. Thus, all leads of the multicore cable extend through the entire length of the multicore cable, and each lead is interrupted once at a different point. This configuration additionally offers more possibilities for an actively driven or passive shielding. The individual shieldings around the leads can additionally be combined with other variants of shielding. [0049] FIG. 6 shows another embodiment of an electrode belt according to the present invention in a schematic sectional view of the carrying belt 2 ′ without electrodes. The edge areas of this belt are designed as a hose-like bead 12 , 12 ′. This bead prevents sharp skin folds from forming and thus effectively counteracts skin irritations or necroses, even in case of long-term application. In an especially advantageous embodiment, these hose-like beads 12 , 12 ′ may be additionally filled with a gas, for example, air, which makes it possible to set the diameter of the hose-like beads. The carrying properties of electrode belts according to the present invention can thus be adapted in terms of their wear comfort to the requirements of different patients. The embodiment as an elastic round bead without a cavity or the possibility of filling is additionally provided in a simplified form. [0050] FIG. 7 shows a schematic view of an electrode belt according to the present invention with a gel pad 13 for supporting the electrodes in the area of the sternum. The electrode belt surrounds the entire upper body of a patient. In the area of the sternum, the upper body has a concave area, in which the electrodes have no contact with the skin without auxiliary means with the belt tightened tightly. A belt-like support means 14 is present for this reason, which spans over the concave area of the upper body. The gel pad 13 , which is a flexible spacer, can be supported on this. As a result, the necessary pressing pressure can be applied to the electrodes 1 - 1 and 1 - 16 via the gel pad 13 in the concave area of the upper body. [0051] FIG. 8 shows a schematic view of a connection element 11 and an electrode attached thereto with a convex contact surface 3 ′. The electrode is embedded in an elastic belt 2 . The connection element 11 is connected to a multicore cable 6 . The individual wires may be connected with each connection element 11 by soldering or by crimping. Spring elements 15 , which extend behind the spherical closure 5 of the contact pin and thus ensure a pushbutton-like connection between the electrode 1 and the connection element 11 , are arranged inside the connection element. Due to being able to slide around the contact pin, the spring elements 15 make possible the rotatable mounting of the connection element 11 , the rotation taking place essentially about the main axis of the contact pin. The spring contact 15 may also be provided formed of an electrically conducting synthetic material. With this, an electrical and mechanical connection may be provided with the connection element 11 to the individual wires by welding or by a melting process. The spring elements 15 may also be provided formed of silicone. The individual wires are then connected with connection element 11 by a vulcanizing process. The spring elements 15 may also be provided formed of various other materials. In such cases the individual wires may be connected with the connection element 11 by means of an electrically conductive glue. [0052] FIG. 9 shows a schematic view of a connection element 11 with an electrode attached thereto, wherein the area of the electric contact is secured against the penetration of liquids. A sealing bead 16 is made integrally in one piece with the elastic belt 2 in the area of contact with the connection element 11 . The body of the connection element 11 has a groove 17 which is complementary to the sealing bead 16 . The sealing bead engages the groove 17 in a positive-locking manner. Nevertheless, the connection remains rotatable. All advantageous embodiments of the present invention can thus be utilized combined with an especially secure contacting. [0053] While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to troughs for use in watering livestock, and more particularly to a trough that automatically maintains a selected volume of water and substantially resists damage to its operative components by livestock. 2. Description of the Prior Art Watering troughs are widely used by livestock producers who raise their livestock in grazing paddocks that do not have natural water sources such as streams or ponds. The use of water troughs is also frequently used for the exclusion of livestock from natural bodies of water. Some water troughs take the form of a simple holding tank that is placed in the pasture and must be manually filled with water that is brought to the trough from a remote source. Some troughs are positioned adjacent to a water source that must be manually actuated, such as a hand pump that is coupled with a well. However, the manual labor required to deliver water to the troughs expends valuable time and, depending on the location of the trough, can be a significant inconvenience. Prior art methods have attempted to automate livestock watering systems. However, those attempts typically resulted in watering troughs that were either too complex and costly to operate or troughs that repeatedly failed to perform their automated function. Oftentimes, the failure of an automated water trough is due to component damage caused by livestock or the elements. As livestock repeatedly come into contact with water supply lines, valves and other such structures, the automated system invariably becomes damaged and fails over time. Harsh winters and dry, hot summers will also wear down component systems, if not causing them to fail suddenly. Accordingly, what is needed is an automated watering system for livestock that is comprised of structural components that resist the damaging effects that livestock and the elements can have on such systems. However, such an automated watering system should also be flexible in use as well as simple and inexpensive to manufacture. SUMMARY OF THE INVENTION The watering trough of the present invention is generally provided with an automated water supply system that maintains a desired volume of water for watering livestock throughout the year. The trough is provided with a base and an outer wall that extends upwardly from a peripheral edge of the base to form an open cavity for holding the water. A fluid supply conduit is positioned to deliver the water to the cavity. In one preferred embodiment, the fluid supply conduit extends beneath the ground surface from a water source and enters the trough through its base. A valve and valve actuator are coupled to the fluid supply conduit and adjusted to permit the flow of water into the cavity until a desired volume is reached, at which time the flow of water is terminated. A preferred embodiment of the trough incorporates an inner wall that at least partially surrounds the valve and valve actuator to substantially limit the incidence of contact between the components and the livestock. The inner wall may be shaped to form a protective tower, which surrounds the valve and valve actuator. An overflow conduit may also be positioned within the protective tower to disperse excess water in the event that the valve actuator fails to terminate the flow of water. To further reduce the incidence of contact between the components and the livestock, the protective tower may extend upwardly from the base of the water trough at a point approximating the center of the trough. Another preferred embodiment fabricates the base and wall of the trough from a portion of a recycled over-the-road tire. A plug is fashioned to seal the bottom opening of the tire, and the protective tower is positioned to extend upwardly from the plug. Such a “tire trough” may be easily incorporated with a heat sink to reduce the chances of the water freezing during the winter. It is therefore one of the principal objects of the present invention to provide an automated watering trough that substantially prevents damage to the automation components and water supply by livestock using the trough. A further object of the present invention is to provide an automated watering trough that substantially prevents damage to the automation components from the weather and other natural elements. Yet another object of the present invention is to provide an automated watering trough that makes a substantial use of recycled products during its construction. Still another object of the present invention is to provide an automated watering trough that is relatively simple in construction. Yet another object of the present invention is to provide an automated watering trough that is easily adapted for a plurality of uses in different settings and environments. A further object of the present invention is to provide an automated watering trough that is easy to use and maintain. These and other objects of the present invention will be clear to those of skill in the art. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an isometric cut-away view of one embodiment of the automated trough of the present invention; FIG. 2 is a partial exploded view of one embodiment of the automation components of the present invention; FIG. 3 is a partial cut-away view of one embodiment of the automation components of the present invention and one method of coupling the same to a trough of the present invention; and FIG. 4 is a partial cut-away view of the automation components of FIG. 2 and one method of coupling the same to a trough of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT The livestock trough 10 of the present invention is generally depicted in FIGS. 1–4 . The trough 10 is provided with a base 12 having an upper surface 14 and a lower surface 16 . A wall 18 extends upwardly from the peripheral edge portion of the base 12 to form an open cavity 20 . It is contemplated that the base 12 and wall 18 could be formed from nearly any material, so long as the material is suitable for extended periods of contact with water. For example, the trough could be formed from metal, such as the ubiquitous round or ovular metal water troughs that are frequently used for watering livestock. The shape of the trough is relatively unimportant and may be configured to fit any particular application. It is preferred, however, that the trough be sized and shaped to support a sufficient volume of water to support the livestock for which it is intended. In a preferred embodiment, the trough is comprised of a recycled over-the-road tire having one of its sidewalls removed. When positioned in a generally horizontal fashion, the base 12 of the trough will be comprised of the remaining side wall, and the wall 18 will be comprised of the tread. In this position, however, the base will have an inner edge portion that defines a large opening 22 in the base 12 . A plug 24 must be used to seal the opening 22 so that the trough 10 will hold a desirable volume of fluid. It is contemplated that the plug 24 could be comprised of nearly any material, such as rubber, metal or concrete. However, in a preferred embodiment, the plug 24 is comprised of a plastic, such as polyethylene or other similar material. A fluid supply conduit 26 should be positioned in selective fluid communication with the cavity 20 to supply the desired volume of water. It is contemplated that the source of the water could be a neighboring body of water, a well or the like. It is further contemplated that the method of delivering the water through the fluid supply conduit 26 could be one of many known methods, including gravity systems, electric pumps, solar-powered pumps, sling pumps, etc. In a preferred embodiment, the fluid supply conduit 26 extends upwardly through an opening 28 in the plug 24 so that it is positioned at least partially within the cavity 20 . It is contemplated, however, that a similar opening could be formed in virtually any other location in the trough, such as the base 12 or the wall 18 through which the fluid supply conduit 26 could be run. Location of the fluid supply conduit 26 through the plug 24 , however, provides a generally centered location for the fluid supply conduit 26 , making it more difficult for the livestock to come into contact with the fluid supply conduit 26 . A valve 30 is coupled to the terminal end of the fluid supply conduit 26 . In a preferred embodiment, a float valve is used, such as the float valves depicted in FIGS. 2–4 . However, other known valves could be interchanged with the float valve to achieve the desired regulation of water through the fluid supply conduit 26 . A valve actuator 32 , such as the ball float 33 depicted in FIGS. 2–4 , is coupled with the valve 30 . Where circumstances deem prudent, many different types of valve actuators could be incorporated with the valve 30 . For example, a ball float 33 may be coupled to the float valve using a substantially rigid arm member 35 ( FIGS. 2 and 3 ) or a substantially flexible cord member, depending on the type of float valve used. To conserve space, a vertically movable float 39 ( FIG. 4 ) can be coupled with the valve 30 and the fluid supply conduit 26 . Other actuators, such as electronic moisture sensors and the like, could be incorporated. Regardless of the type of actuator 32 or valve 30 used with the system, the principal function of the two will be to regulate the flow of the water from the fluid supply conduit 26 until a desired volume is attained. At that point, the actuator 32 should function to simply close the valve 30 . It is preferred that the actuator be adjustable to alter the volume of fluid within the trough 10 as desired. In a preferred embodiment, an inner wall 34 is coupled to the trough 10 so that it at least partially surrounds the valve 30 and valve actuator 32 , forming a protective tower to further reduce the likelihood of contact between the fluid supply line 26 , the valve 30 , or the valve actuator 32 with the livestock. As depicted in FIGS. 3 and 5 , the inner wall 34 is shaped to define an inner chamber 36 , which should be sized and shaped to house the valve 30 and valve actuator 32 accordingly. Where desirable, an overflow conduit 41 may be positioned within the inner chamber 26 at a desired height from the base 12 or plug 24 so that the fluid within the cavity 20 will not overflow in the event that the valve 30 and/or valve actuator 32 fail. A removable cap 38 may be removably coupled to the inner wall 34 to further protect the structures positioned within the inner chamber 36 , while permitting access for maintenance. The inner wall 34 should be secured to the plug 24 (or other structural member from which it will depend) in a watertight fashion. As depicted in FIGS. 2 , 3 and 5 , the inner wall 34 may be secured to a water access cover 40 , which can be fastened to the plug 24 over an optional access hole 45 formed within the plug 24 . The type of fastener 42 used will depend upon the materials selected for the plug 24 . However, in the example of a plastic member, stainless steel screws are an example of one type of appropriate fastener. To further guarantee a watertight seal, an O-ring 43 can be secured between the plug 24 and the water access cover 40 around the access opening 45 . The plug 24 , where a plastic or rubber material is used, can be secured to the base 12 adjacent the opening 22 by first applying a layer of sealant between the plug 24 and the base 12 . The plug 24 can then be fastened to the base 12 using an appropriate fastener, such as the stainless steel screws 44 . However, the type of fastener 44 used may change where the materials for the plug 24 and the base 12 require. To substantially drain the volume of fluid from the cavity 20 , a drain hole 46 should be formed within the base 12 or wall 18 . A drain plug 48 should be provided to adequately seal the drain hole 46 when the trough 10 is in use. Press-fit, threadably-mated, and other drain plugs 48 are contemplated. The design of the trough 10 is sufficiently flexible to accommodate additional structures and features. For example, the trough 10 may be supported above ground level by a base, which could be comprised of a second over-the-road tire, to provide an elevated drinking position for the livestock. Where a heat sink is desired in colder climates, the trough 10 is easily positioned above a hole in the ground, which is dug deeper than the frost line. One or more heat conduits could be inserted through the base 12 or plug 24 to direct the passage of heat from below the frost line, up through the hole in the ground, and through the heat conduits, forming a heat sink to substantially prevent the fluid within the cavity 20 from freezing. In the drawings and in the specification, there have been set forth preferred embodiments of the invention; and although specific items are employed, these are used in a generic and descriptive sense only and not for purposes of limitation. Changes in the form and proportion of parts, as well as substitution of equivalents, are contemplated as circumstances may suggest or render expedient without departing from the spirit or scope of the invention as further defined in the following claims. Thus it can be seen that the invention accomplishes at least all of its stated objectives.

1a

CLAIM OF PRIORITY [0001] This patent application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61/075,124, filed on Jun. 24, 2008, which application is herein incorporated by reference in its entirety. TECHNICAL FIELD [0002] This invention relates generally to an electronic signal processing circuit for adapting a polarized respiratory air temperature and pressure change sensor to a conventional polysomnograph (PSG) machine of the type commonly used in sleep laboratory applications, and more particularly to an adapter that simultaneously processes two separate polyvinylidene (PVDF) film transducer signals. More specifically one signal from a temperature change sensing PVDF film transducer and another signal from a pressure change sensing PVDF film transducer signal. BACKGROUND [0003] In addressing sleep related problems, such as sleep apnea, insomnia and other physiologic events or conditions occurring during sleep, various hospitals and clinics have established laboratories sometimes referred to as “Sleep Laboratories” (sleep labs). At these sleep labs, using instrumentation, such as patient bio-data sensors connected to a polysomnograph (PSG) machine, a patient's sleep patterns may be monitored and recorded for later analysis so that a proper diagnosis may be made and a therapy prescribed. Varieties of sensors have been devised for providing recordable signals related to respiratory (inhaling and exhaling) patterns during sleep. These sensors commonly are mechanical to electrical transducers that produce an electrical signal related to respiration. [0004] Current practice and procedure in sleep labs use two different sensing systems at the same time on the same patient that measure respiratory air temperature and pressure. Respiratory air temperature is typically measured using either a thermocouple or a thermistor attached directly to a sleep labs PSG machine. Respiratory air pressure is often measured using a nasal pressure prong cannula placed in the patient's nostrils and attached via a plastic hose to an air pressure transducer. The output of air pressure transducers connect directly to PSG machines. [0005] Air pressure transducers with nasal cannulas in combination with either a thermistor or thermocouple, as used in sleep studies, are invasive, uncomfortable and prone to clogging and body movement and thus put an unnecessary strain and discomfort on the patients. SUMMARY [0006] The present inventor has recognized, among other things, that there is a need to there is a need to provide an apparatus and method for processing respiratory air temperature and pressure change transducer signals that does not require the patient to wear two different and separate temperature and pressure sensors apparatus at the same time in nearly the same space. [0007] Furthermore, there is a need for an apparatus and method for simultaneously processing respiratory air temperature and pressure change transducer signals in order to provide a rigid phase and polarity relationship between respiratory air temperature and pressure to final graphical indication of the individually processed PVDF film transducers signals on the PSG machine display. [0008] Furthermore, there is a need to provide an apparatus and method for processing respiratory air temperature and pressure change transducer signals in order to provide the sleep professional with a simpler method to diagnose sleep related disorders. [0009] Furthermore, there is also a need to provide an apparatus and method for processing respiratory air temperature and pressure change transducer signals in order to provide a rigid phase relationship between respiratory airflow (inspiration and expiration) to final graphical indication of the polarized piezoelectric film sensor signals on the PSG machine display. [0010] In certain examples, a PVDF film can have both pyroelectric and piezoelectric properties and, as such, can be responsive to both inspiratory and expiratory air temperature and air pressure changes, producing a corresponding polarized electrical signal output indicating either inspiratory air temperature and pressure or expiratory air temperature and pressure. The polarized electrical sensor output signal can be processed to effectively separate the inspiratory or expiratory temperature change induced signal from the signal due to inspiratory or expiratory pressure change. [0011] The present inventor has recognized, among other things, that an apparatus and method can be provided for processing respiratory air temperature and pressure change transducer signals for a polarized respiratory air temperature and pressure change sensor especially constructed to simultaneously detect respiratory air temperature and pressure changes at the same time with a single sensor for the comfort of a patient undergoing evaluation. [0012] In certain examples, an adaptor can be provided for simultaneously processing the signals of a temperature change sensing PVDF film transducer and a pressure change sensing PVDF film transducer for further connection to a PSG machine. [0013] In an example, the adapter can include two independent sets of differential amplifier and integrator circuits with resistive reset having a pair of input terminals that are adapted to be coupled to the outputs of a temperature change sensing PVDF film transducer and a pressure change sensing PVDF film transducer the polarized piezoelectric film sensor. The differential amplifier and signal integrator with resistive reset can be configured to provide a predetermined gain factor to amplify the temperature change sensing and the pressure change sensing PVDF film transducer output signals, to provide transducer signal averaging over time to reduce unwanted differential noise, and to significantly attenuate common-mode noise. Each of the outputs of the two differential amplifier and signal integrator with resistive reset circuits can be fed to a set of signal output attenuators. [0014] By utilizing a differential input amplifier with a predetermined gain factor and by appropriately conditioning the amplified temperature change sensing and pressure change sensing PVDF film transducer output signals, the resulting filter outputs can be readily matched to existing PSG machines already on hand in most sleep laboratories. [0015] The temperature change sensing and the pressure change sensing PVDF film transducers that are part of a respiratory airflow temperature and pressure change sensor can sense thermal and mechanical energies well in the GHz range. In various examples, because the normal human adult resting respiration rate can be relatively slow (e.g., 12 to 20 breaths per minute), irregular in frequency and amplitude and in a distorted sinusoidal form, the raw PVDF film transducer signals can be averaged over time to condition the signal for graphical presentation in the PSG machine. Sensor signal averaging over time can remove undesired patient motion signals and other environmentally induced noise signal artifacts. [0016] Polarized lead wires can be provided to interface the PVDF film transducers and the PSG machine. One wire may be outfitted with a red marking and is designated positive. The other wire may be outfitted with a black marking and is designated negative. The PVDF film transducer can generate a direct current (DC) voltage, much like a battery, when subjected to temperature and pressure variations during exhaling and inhaling. During respiration, the temperature sensing PVDF film transducer can be subjected to a change in thermal energy of expired air molecules and the pressure sensing PVDF film transducer can be subjected to a change in kinetic energy of expired air molecules. Lead wires can be provided to interface between the sensor and the PSG machine. In an example, the positive designated PVDF film transducer surface electrode can become negatively charged when exhaling, and the positive designated PVDF film transducer surface electrode can become positively charged when inhaling. Accordingly, the negative designated PVDF film transducer surface electrode can become negatively charged when inhaling, and the negative designated PVDF film transducer surface electrode can become positively charged when exhaling. [0017] In an example, when a negative voltage/charge is presented to the PSG input reference terminal, an upward deflection on the PSG display can indicate a respiratory exhalation effort. When a positive voltage/charge is presented to the PSG input reference terminal, a downward deflection on the PSG display can indicate a respiratory inhalation effort. [0018] In order to maintain the polarity processing properties and to minimize potentially long phase delays, all electronic signal-processing paths can be DC coupled. Persons skilled in the art will recognize the DC coupling when reviewing the disclosed schematic diagram by the absence of capacitors in the forward signal paths in any of the electronic building blocks. [0019] In an example, multiple polarity indicating outputs can be created using two polarized piezoelectric film sensors. Typically, the respiratory air temperature and pressure change transducers can be constructed of polyvinylidene (PVDF) film and can be included as part of a polarized respiratory air temperature and pressure change sensor. The adapter apparatus can contain a respiratory air temperature change signal-processing channel and a respiratory air pressure change signal-processing channel. The input section of the respiratory air temperature change signal-processing channel can consist of a differential amplifier and integrator with resistive reset coupled to receive the temperature change signal from the PVDF film transducer that makes up the sensing apparatus in the polarized respiratory air temperature and pressure change sensor. The input section of the respiratory air pressure change signal-processing channel can consist of a differential amplifier and integrator with resistive reset coupled to receive the pressure change signal from the PVDF film transducer that makes up the sensing apparatus in the polarized respiratory air temperature and pressure change sensor. Further, the signal processing channels can render the sensor outputs compatible with existing PSG machines. [0020] In Example 1, an adapter apparatus for simultaneously processing respiratory air temperature information and respiratory air pressure information includes an electronic signal processing circuit configured to receive information indicative of respiratory air temperature from a respiratory air temperature piezoelectric film sensor and to receive information indicative of respiratory air pressure from a respiratory air pressure piezoelectric film sensor, wherein the electronic signal processing circuit is configured to simultaneously process the received respiratory air temperature information and the received respiratory air pressure information to produce a first signal output indicative of respiratory air temperature and a second signal output indicative of respiratory air pressure. The electronic signal processing circuit includes a first differential amplifier and signal integrator with resistive reset configured to average the received respiratory air temperature information to reduce differential noise and to attenuate common mode noise, and a second differential amplifier and signal integrator with resistive reset, separate from the first differential amplifier and signal integrator with resistive reset, configured to average the received respiratory air pressure information to reduce differential noise and to attenuate common mode noise. [0021] In Example 2, the adapter apparatus of Example 1 optionally includes the respiratory air temperature piezoelectric film sensor and the respiratory air pressure piezoelectric film sensor. [0022] In Example 3, the respiratory air temperature piezoelectric film sensor of any one or more of Examples 1-2 optionally includes a polyvinylidene fluoride film sensor configured to detect respiratory air temperature information. [0023] In Example 4, the respiratory air pressure piezoelectric film sensor of any one or more of Examples 1-3 optionally includes a polyvinylidene fluoride film sensor configured to detect respiratory air pressure information. [0024] In Example 5, the adapter apparatus of any one or more of Examples 1-4 optionally includes a single polyvinylidene fluoride film sensor configured to detect respiratory air temperature information and respiratory air pressure information, the single polyvinylidene fluoride film sensor including the respiratory air temperature piezoelectric film sensor and the respiratory air pressure piezoelectric film sensor. [0025] In Example 6, the respiratory air temperature piezoelectric film sensor and the respiratory air pressure piezoelectric film sensor of any one or more of Examples 1-5 are optionally configured to provide a rigid phase and polarity relationship between respiratory air temperature and respiratory air pressure. [0026] In Example 7, the first and second differential amplifiers and signal integrators with resistive resets of any one or more of Examples 1-6 are optionally configured to provide a predetermined gain factor by which the received respiratory air temperature information and the received respiratory air pressure information are amplified, to provide signal averaging over time to reduce differential noise, and to attenuate common-mode noise. [0027] In Example 8, the electronic signal processing circuit of any one or more of Examples 1-7 optionally includes a first third order Butterworth low pass filters configured to remove components from the received respiratory air temperature information having a frequency above approximately 125 mHz, and a second third order Butterworth low pass filters configured to remove components from the received respiratory air pressure information having a frequency above approximately 1 Hz. [0028] In Example 9, the first and second differential amplifiers and signal integrators with resistive resets of any one or more of Examples 1-8 are optionally configured to average the received respiratory air temperature information and the received respiratory air pressure information using a time constant based on a respiratory response time. [0029] In Example 10, the first signal output indicative of respiratory air temperature of any one or more of Examples 1-9 optionally includes the averaged received respiratory air temperature information, and the second signal output indicative of respiratory air pressure includes the averaged received respiratory air pressure information. [0030] In Example 11, the adapter apparatus of any one or more of Examples 1-10 optionally includes a cable configured to couple the integrated sensor to a PSG machine, wherein the electronic signal processing circuit is integrated with the cable. [0031] In Example 12, a system includes a respiratory air temperature piezoelectric polyvinylidene fluoride film sensor configured to detect a respiratory air temperature of a subject, a respiratory air pressure piezoelectric polyvinylidene fluoride film sensor configured to detect a respiratory air pressure of the subject, an electronic signal processing circuit configured to receive information indicative of a respiratory air temperature from the respiratory air temperature piezoelectric polyvinylidene fluoride film sensor and information indicative of a respiratory air pressure from the respiratory air pressure piezoelectric polyvinylidene fluoride film sensor, wherein the electronic signal processing circuit is configured to simultaneously process the received respiratory air temperature information and the received respiratory air pressure information to produce a first signal output indicative of respiratory air temperature and a second signal output indicative of respiratory air pressure. The electronic signal processing includes a first differential amplifier and signal integrator with resistive reset configured to average the received respiratory air temperature information to reduce differential noise and to attenuate common mode noise, and a second differential amplifier and signal integrator with resistive reset, separate from the first differential amplifier and signal integrator with resistive reset, configured to average the received respiratory air pressure information to reduce differential noise and to attenuate common mode noise. The first signal output indicative of respiratory air temperature includes the averaged received respiratory air temperature information, and the second signal output indicative of respiratory air pressure includes the averaged received respiratory air pressure information. The system further includes a polysomnograph machine, coupled to the electronic signal processing circuit, the polysomnograph machine configured to receive the averaged received respiratory air temperature and the averaged received respiratory air pressure information from the electronic signal processing circuit and to provide the averaged received respiratory air temperature information and the averaged received respiratory air pressure information to a user. [0032] In Example 13, the system of Example 12 optionally includes a single polyvinylidene fluoride film sensor configured to detect respiratory air temperature information and respiratory air pressure information, the single polyvinylidene fluoride film sensor including the respiratory air temperature piezoelectric polyvinylidene fluoride film sensor and the respiratory air pressure piezoelectric polyvinylidene fluoride film sensor. [0033] In Example 14, a method for simultaneously processing respiratory air temperature information and respiratory air pressure information includes receiving information indicative of respiratory air temperature of a subject from a respiratory air temperature piezoelectric film sensor and information indicative of respiratory air pressure of the subject from a respiratory air pressure piezoelectric film sensor, and simultaneously processing the received respiratory air temperature information and the received respiratory air pressure information to produce a first electronic signal output indicative of respiratory air temperature and a second electronic signal output indicative of respiratory air pressure. The processing includes averaging the received respiratory air temperature information using a first differential amplifier and signal integrator with resistive reset to reduce differential noise and to attenuate common-mode noise, and averaging the received respiratory air pressure information using a second differential amplifier and signal integrator with resistive reset, separate from the first differential amplifier and signal integrator with resistive reset, to reduce differential noise and to attenuate common-mode noise. [0034] In Example 15, the receiving the respiratory air temperature information of Example 14 optionally includes using a respiratory air temperature piezoelectric polyvinylidene fluoride film sensor, and the receiving the respiratory air pressure information include using a respiratory air pressure piezoelectric polyvinylidene fluoride film sensor. [0035] In Example 16, the receiving the respiratory air temperature information and the receiving the respiratory air pressure information of any one or more of Examples 14-15 optionally includes using a single polyvinylidene fluoride film sensor configured to detect respiratory air temperature information and respiratory air pressure information. [0036] In Example 17, the receiving the respiratory air temperature information and the respiratory air pressure information of any one or more of Examples 14-16 optionally includes receiving rigid phase and polarity relationship information between respiratory air temperature and respiratory air pressure. [0037] In Example 18, the simultaneously processing the received respiratory air temperature information and the received respiratory air pressure information of any one or more of Examples 14-17 optionally includes amplifying the received respiratory air temperature information and the received respiratory air pressure information by a predetermined gain factor using the first and second differential amplifiers and signal integrators with resistive resets, to provide signal averaging over time to reduce differential noise, and to attenuate common-mode noise. [0038] In Example 19, the simultaneously processing the received respiratory air temperature information and the received respiratory air pressure information of any one or more of Examples 14-18 optionally includes removing components from the received respiratory air temperature information having a frequency above approximately 125 mHz using a first third order Butterworth low pass filter, and removing components from the received respiratory air pressure information having a frequency above approximately 1 Hz using a second third order Butterworth low pass filter. [0039] In Example 20, the averaging the received respiratory air temperature information and the received respiratory air pressure information of any one or more of Examples 14-19 optionally includes using a time constant based on a respiratory response time of the subject. [0040] Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. DESCRIPTION OF THE DRAWINGS [0041] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. [0042] The forgoing features, objects and advantages of the invention will become apparent to those skilled in the art from the following detailed description of a preferred embodiment, especially when considered in conjunction with the accompanying drawings in which like the numerals in the several views refer to the corresponding parts: [0043] FIGS. 1-3 illustrate generally an example of a system including an adapter apparatus for processing respiratory air temperature and pressure change transducer signals. [0044] FIG. 4 illustrates generally an example of a schematic diagram of an adapter apparatus for processing respiratory air temperature and pressure change transducer signals. DETAILED DESCRIPTION [0045] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. [0046] FIG. 1 illustrates generally an example of a system including an adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals. Referring to FIG. 1 , there is indicated generally by numeral 1 a typical sleep laboratory patient who has been outfitted with a respiratory air temperature and pressure change sensor 2 to measure respiratory air flow. A pair of temperature signal leads 3 and a pair of pressure signal leads 4 connect the respiratory air temperature and pressure change sensor 2 to the adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals. [0047] This specific exemplary embodiment shows two polarity indicating output wire pairs 6 and 7 connecting the adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals and presenting same to a conventional, commercially-available PSG machine 8 , such as: [0048] Model Sandman available from Covidien of Kanata, ON Canada; [0049] Model Alice available from Respironics Inc of Murrysville, Pa.; [0050] Model Connex available from Natus Medical of Oakville, ON Canada; [0051] Model Harmonie-S available from Stellate of Montreal, QC Canada; [0052] Model Polysmith available from Nihon Kohden America of Foothill Ranch, Calif.; [0053] Model Comet available from Astro-Med, Inc of West Warwick, R.I.; [0054] Model Embletta available from Embla of Broomfield, Colo.; [0055] Model E Series available from Compumedics of Charlotte, N.C.; [0056] Model 20B available from CleveMed of Cleveland, Ohio; [0057] Model Somnostar available from Cardinal Health of Yorba Linda, Calif.; [0058] Model Easy II available from Cadwell Laboratories, Inc of Kennewick, Wash.; [0059] Model Pursuit Sleep2 available from Braebon of Ogdensburg, N.Y.; or [0060] Model SleepScan available from Natus Medical of Mundelein, Ill. [0000] All trademarks are property of their respective owners. This list is only exemplary in nature and does not claim to be comprehensive or complete. [0061] In a typical sleep laboratory application, temperature signal output 6 is configured to produce the respiratory air temperature change showing inhalation as an upward deflection of respiratory effort and showing exhalation as a downward deflection of respiratory effort on the PSG machine 8 display. [0062] Furthermore, pressure signal output 7 is configured to produce the respiratory air pressure change showing inhalation as an upward deflection of respiratory effort and showing exhalation as a downward deflection of respiratory effort on the PSG machine 8 display. [0063] It is by international convention and by requirement of the American Association of Sleep Medicine (AASM) that a patient's inhalation produces an upward deflection and exhalation produces a downward deflection on the PSG machine 8 display. [0064] FIG. 2 illustrates generally an example of a system including an adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals, including an example of wiring connections connecting the adapter apparatus 5 to the respiratory air temperature and pressure change sensor 2 . In an example, the respiratory air temperature and pressure change sensor 2 can include a temperature change sensing PVDF film transducer 10 and a pressure change sensing PVDF film transducer 20 . A pair of temperature signal leads 3 and a pair of pressure signal leads 4 connect the respiratory air temperature and pressure change sensor 2 to the adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals. [0065] This specific exemplary of the embodiment shows two polarity indicating output wire pairs 6 and 7 connecting the adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals to a conventional, commercially-available PSG machine 8 . [0066] FIG. 3 illustrates generally an example of a system including an adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals, including an example of functional components included in the adapter apparatus 5 . [0067] The temperature change sensing PVDF film transducer 10 in one example is constructed in accordance with the teachings of the commonly-assigned Reinhold Henke et al. U.S. Provisional Application 61/075,124, entitled “Polarized Respiratory Air Temperature and Pressure Change Sensor,” filed on Jun. 24, 2008, incorporated herein in its entirety. The sensor 10 is adapted to sense a patient's inspiratory and expiratory air temperature. [0068] In an example, the temperature change sensing PVDF film transducer 10 connects to the respiratory air temperature signal path differential amplifier and integrator with resistive reset 40 via a pair of input wire leads 2 - 14 . [0069] In this example, wire 12 of the input wire pair is indicated to represent the positive terminal of the temperature change sensing PVDF film transducer that goes positive when patient is inhaling. Further, wire 14 of the input wire pair is indicated to represent the negative terminal of the temperature change sensing PVDF film transducer that goes positive when patient is inhaling. The differential amplifier and integrator with resistive reset 40 of the respiratory air temperature change signal path comprises a differential type amplifier which functions to increase the common-mode rejection of the adapter apparatus 5 so as to make it less susceptible to 60 Hz noise present in the environment as well as to motion artifacts. The signal integrator with resistive reset serves to slowly average the incoming signal over time so that the differential amplifier only amplifies signals that are within the response time of interest, i.e., the patient's respiratory response time. In various examples, the averaging signal integrator may operate with a fixed time constant of about 62.5 ms. [0070] Without limitation, the differential amplifier and integrator with resistive reset 40 may have a gain in the range of from 2 to 10 with about 6.2 being quite adequate. [0071] The output signal from the differential input amplifier and integrator with resistive reset 40 on lead 42 is applied to a 3 rd -order Butterworth low pass filter 44 . It should be understood by those skilled in the art that the type of filter response is neither limited to a 3 rd -order filter nor is it limited to a Butterworth response. Other filter responses may also be used. [0072] Typically, but not limited to, the cut-off frequency for the third order Butterworth low pass filter 44 may be about 125 mHz. [0073] As seen in the example of FIG. 2 , the output 72 of the respiratory air temperature change signal path low pass filter 44 can connect to an input of the respiratory air temperature change signal path output attenuator module 84 . [0074] In an example, the respiratory air temperature change signal path output attenuator 84 attenuates the signal coming from the respiratory air temperature change signal path low pass filter module 44 in order to reduce the temperature change signal path amplitude to a level that is compliant with the requirements of the input specifications of the input jack of the particular PSG machine 8 employed by way of lines 90 and 92 respectively. [0075] It should be clear to those skilled in the art that the entire temperature signal path starting from the polarized piezoelectric film sensor 10 and ending at the PSG machine 8 is DC coupled, thus ensuring that the relationship of polarized piezoelectric film sensor polarity and indication of respiration effort between inhalation and exhalation on the PSG machine is purposely maintained. [0076] The pressure change sensing PVDF film transducer 20 is in some examples is constructed in accordance with the teachings of the afore-referenced patent application of Reinhold Henke and entitled “Polarized Respiratory Air Temperature and Pressure Change Sensor”. The sensor 20 is adapted to sense a sleep lab subject's inspiratory and expiratory air pressure. [0077] The pressure change sensing PVDF film transducer 20 connects to the respiratory air pressure signal path differential amplifier and integrator with resistive reset 60 via a pair of input wire leads 22 - 24 . [0078] Wire 22 of the input wire pair is indicated to represent the positive terminal of the pressure change sensing PVDF film transducer that goes positive when patient is inhaling. [0079] Wire 24 of the input wire pair is indicated to represent the negative terminal of the pressure change sensing PVDF film transducer that goes positive when patient is inhaling. The differential amplifier and integrator with resistive reset 60 of the respiratory air pressure change signal path comprises a differential type amplifier which functions to increase the common-mode rejection of the adapter apparatus 5 so as to make it less susceptible to 60 Hz noise present in the environment as well as to motion artifacts. The signal integrator with resistive reset serves to slowly average the incoming signal over time so that the differential amplifier only amplifies signals that are within the response time of interest, i.e., the patient's respiratory response time. In various examples, the averaging signal integrator may operate with a fixed time constant of about 62.5 ms. [0080] Without limitation, the differential amplifier and integrator with resistive reset 60 may have a gain in the range of from 2 to 10 with about 6.2 being adequate. [0081] The output on wire 62 from the differential input amplifier and integrator with resistive reset 60 is applied to a third order Butterworth low pass filter 64 . The input of the respiratory air pressure change signal path low pass third order Butterworth filter 64 is connected to the output wire 62 of the differential input amplifier 60 . [0082] It should be understood by those skilled in the art that the type of filter response is neither limited to a third order filter nor is it limited to a Butterworth response. Other filter responses may also be used. [0083] Typically, the cut-off frequency for the third order Butterworth low pass filter 64 may be about 1 Hz, but limitation thereto is not intended. [0084] The output on line 74 of the respiratory air pressure change signal path low pass filer 3rd order Butterworth filter module 64 connects to the input of the respiratory air pressure change signal path output attenuator module 88 . [0085] The respiratory air pressure change signal path output attenuator 88 functions to attenuate the signal coming from the respiratory air pressure change signal low pass filter 3rd order Butterworth filter module 64 in order to reduce the pressure change signal path amplitude to a level that is compliant with the requirements of the input specifications of the input jack of the PSG machine 8 by way of lines 96 and 98 respectively. [0086] It should be clear to those skilled in the art that the entire pressure signal path starting from the polarized piezoelectric film sensor 20 and ending at the PSG machine 8 is DC coupled, thus ensuring that the relationship of polarized piezoelectric film sensor polarity and indication of respiration effort between inhalation and exhalation on the PSG machine is purposely maintained. [0087] Having described an example overall configuration of the adapter apparatus of FIG. 3 , a more detailed explanation of a specific implementation of the adapter will now be presented and, in that regard, reference is made to the schematic circuit diagram of FIG. 4 . [0088] FIG. 4 illustrates generally an example of a schematic diagram of an adapter apparatus 5 for processing respiratory air temperature and pressure change transducer signals. [0089] In an example, the adapter apparatus 5 can be integrated with the cable used to couple the temperature change and pressure change sensing PVDF film transducers 10 and 20 , respectively, to the polysomnograph machine 8 . As such, it incorporates its own power supply and virtual ground generator 50 in the form of a single lithium battery 52 with its positive battery voltage terminal 53 identified as V+and its negative battery voltage terminal 54 labeled V-. A resistor 55 connects the positive battery voltage terminal to a virtual ground point 59 . A resistor 56 connects the negative battery voltage terminal to the virtual ground point 59 . Resistors 55 and 56 are preferably of equal value in establishing virtual ground point 59 . A polarized capacitor 57 connects in parallel with resistors 56 to form a low alternating current (AC) impedance return path from the negative battery terminal 54 to the virtual ground point 59 . [0090] The input terminal 12 to the differential amplifier and integrator with resistive reset 40 is coupled, via resistor 402 to the inverting input of operational amplifier 416 , to the gain setting and integrator resetting resistor 410 and to the integrating capacitor 412 . The input terminal 14 connects to the non-inverting input of differential operational amplifier and integrator with resistive reset 416 , via a resistor 404 and to an input load resistor 408 . [0091] The output from the differential input amplifier circuit 416 appears on lead 42 and connects to the respiratory air temperature change signal path third order Butterworth low-pass filter circuit 44 . [0092] Referring to filter circuit 44 , the input appearing on lead 42 is applied, via series connected resistors 442 , 448 and 450 , to the non-inverting input of an operational amplifier 460 and those resistors, along with capacitors 446 , 454 and 458 cooperate with the operational amplifier 460 to function as a low-pass Butterworth filter. The output of the operational amplifier 460 is presented to lead 72 . [0093] The values of the resistors 442 , 448 and 450 and the capacitors 446 , 454 and 458 may be set to establish a cut-off frequency of the third order Butterworth low-pass filter circuit 44 to about 125 mHz as mentioned previously. [0094] Lead 72 feeds into the respiratory air temperature change signal path output attenuator 84 , which comprises a voltage divider including resistors 902 and 904 to drop the polarized piezoelectric film sensor based signal component to acceptable levels of the PSG machine to which the polarized piezoelectric film sensor is being interfaced via a pair of lead wires 90 and 92 , respectively. [0095] The input terminal 22 of the differential amplifier and integrator with resistive reset 60 is coupled, via resistor 602 to the inverting input of operational amplifier 616 , to the gain setting and integrator-resetting resistor 610 and to the integrating capacitor 612 . The input terminal 24 of the differential amplifier and integrator with resistive reset 60 is coupled, via resistor 604 to the non-inverting input of operational amplifier 616 and to the input load resistor 608 . [0096] The output from the differential input amplifier circuit 616 appears on lead 62 and connects to the respiratory air pressure signal path third order Butterworth low-pass filter circuit 64 . [0097] Referring to filter circuit 64 , the input appearing on lead 62 is applied, via series connected resistors 642 , 654 and 650 , to the non-inverting input of an operational amplifier 660 and those resistors, along with capacitors 646 , 652 and 658 cooperate with the operational amplifier 660 to function as a low-pass filter. The output of the operational amplifier 660 is presented on lead 74 . [0098] The values of the resistors 642 , 648 and 650 and the capacitors 646 , 654 and 658 may be set to establish a cut-off frequency of the third order Butterworth low-pass filter circuit 64 to about 1 Hz as mentioned previously. [0099] Lead 74 feeds into the respiratory air pressure change signal path output attenuator 88 , which comprises a voltage divider including resistors 962 and 964 to drop the polarized piezoelectric film sensor based signal component to acceptable levels of the PSG machine to which the polarized piezoelectric film sensor is being interfaced via a pair of lead wires 96 and 98 , respectively. [0100] The list of specific components used to assemble a printed circuit board assembly is known in the industry as a Bill-of-Materials (BOM). Below is an example of a BOM for one embodiment of the components of FIG. 4 . [0000] B1 BR2330A/FA C1 0.1 uF C3 1 uF C5 0.39 uF C6 0.056 uF C7 0.1 uF C8 1 uF C9 0.39 uF C10 0.056 uF C11 10 uF/tant R1 1.00 M R2 100k R3 100k R4 10.0k R5 560k R6 560k R7 560k R9 1.00k R11 2.7 M R16 100k R18 10.0k R19 1.00 M R20 3.30 M R21 3.30 M R22 3.30 M R23 1.00k R24 100k R25 2.70 M R26 330k R27 330k U1:A LMC6442AIM U1:B LMC6442AIM U2:A LMC6442AIM U2:B LMC6442AIM [0101] During operation in a typical application, such as in a sleep laboratory, a patient is fitted with a polarized respiratory air temperature and pressure change sensor. In an example, the polarized respiratory air temperature and pressure change sensor can be connected using an adapter apparatus to a PSG machine. The adapter apparatus has been described herein for sleep scientists, sleep physicians and sleep technicians to see, detect and properly diagnose specific sleep disorders and diseases which including abnormal respiratory events including events occurring in the upper airway of the patient. [0102] This invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment and operating procedures, can be accomplished without departing from the scope of the invention itself. [0103] The description of the various embodiments is merely exemplary in nature and, thus, variations that do not depart from the gist of the examples and detailed description herein are intended to be within the scope of the present disclosure. Such variations are not to be regarded as a departure from the spirit and scope of the present disclosure.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/568,498, filed Dec. 8, 2011, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD [0002] The present disclosure relates generally to the visualization of vessels and, in particular, the visualization of vessels having a blockage or other restriction to the flow of fluid through the vessel. Aspects of the present disclosure are particularly suited for evaluation of biological vessels in some instances. For example, some particular embodiments of the present disclosure are specifically configured for the visualizing and treating total occlusions of human blood vessels, such as a chronic total occlusion, an acute total occlusion, or a severe stenosis. BACKGROUND [0003] Intravascular ultrasound (IVUS) imaging systems have been designed for use by interventional cardiologists in the diagnosis and treatment of cardiovascular and peripheral vascular disease. Such systems enhance the effectiveness of the diagnosis and treatment by providing important diagnostic information that is not available from conventional x-ray angiography. This information includes the location, amount, and composition of arteriosclerotic plaque and enables physicians to identify lesion characteristics, select an optimum course of treatment, position therapeutic devices and promptly assess the results of treatment. [0004] Such IVUS systems generally include an IVUS device having one or more miniaturized transducers mounted on the distal portion of a catheter or guide wire to provide electronic signals to an external imaging system. The external imaging system produces an image of the lumen of the artery or other cavity into which the catheter is inserted, the tissue of the vessel, and/or the tissue surrounding the vessel. Problems encountered with these systems include clearly visualizing the tissue around the catheter, and identifying the precise location of the image with regard to known spatial references, such as angiographic references. [0005] Before the development of less invasive approaches, the principal mode of treatment for occluded arteries was bypass surgery and, in the case of occlusions in the coronary arteries, coronary artery bypass surgery. Coronary artery bypass surgery is a highly invasive procedure in which the chest cavity is opened to expose the heart to provide direct surgical access to the coronary arteries. The procedure also includes the surgical removal of blood vessels from other locations in the patient's body (e.g., the sapheneous vein) which then are grafted surgically to the coronary arteries to bypass the occlusions. The recuperative period is lengthy with considerable discomfort to the patient. [0006] The use of less invasive, catheter-based, intravascular techniques has developed for several decades and may be considered as the preferred mode of treatment for those patients amenable to such treatment. Typically, the intravascular procedures, such as angioplasty, atherectomy, and stenting require preliminary navigation of a guidewire through the patient's arteries to and through the occlusion. This guidewire, so placed, serves as a rail along which catheters can be advanced directly to and withdrawn from the target site. Total occlusions often cannot be treated with such minimally invasive intravascular approaches because of the inability to advance a guidewire through the stenosis. Typically patients with such occlusions have been treatable, if at all, by bypass surgery. Although in some instances, physicians may be able to force a guidewire through a total occlusion if the occluding material is relatively soft, attempts to force the guidewire through can present serious risks of perforating the artery. Arterial perforation can be life threatening. [0007] The difficulties presented when trying to cross a total or near-total occlusion are compounded by the typical manner in which the anatomy of an occluded artery is diagnosed. Conventionally, such diagnosis involves an angiographic procedure in which a radiopaque contrast liquid is injected into the artery upstream of the occlusion and a radiographic image is made. The resulting image is that of the compromised lumen which necessarily differs from the natural arterial lumen. Although with angiographic visualization techniques, the physician can determine the location of the occluded region and an indication of the degree of obstruction, angiographic images do not provide a clear understanding of where, in the occluded region, the natural boundaries of the vessel are located. [0008] As used herein, the term “severe occlusion” or “severe obstruction” is intended to include total occlusions as well as those occlusions and stenoses that are so restrictive as to require preliminary formation of a passage through the occlusion in order to receive additional intravascular therapeutic devices. Such occlusions have various causes and occur in both the arterial or venous systems. Total or near total occlusions occur in some instances as a consequence of the build-up of plaque or thrombus, the latter being problematic in arteries as well as in the venous system. For example, deep veined thrombus and thrombotic occlusion of vein grafts are serious conditions requiring treatment. [0009] As noted above, recently techniques and systems have been developed to visualize the anatomy of vascular occlusions by using intravascular ultrasound (IVUS) imaging. IVUS techniques are catheter-based and provide a real-time sectional image of the arterial lumen and the arterial wall. An IVUS catheter includes one or more ultrasound transducers at the distal portion of the catheter by which images containing cross-sectional information of the artery under investigation can be determined. The ultrasound transducer(s) are typically spaced from the distal tip of the catheter. In that regard, the catheters typically include a distal tip formed of a radiopaque material such that the distal tip of the catheter is identifiable on fluoroscopy, x-ray, angiograph, or other similar imaging techniques. As a result of the distal tip, the ultrasound transducer(s) may be anywhere from one to five centimeters proximal of the distal tip of the catheter. For example, in each of the Atlantis SR Pro Imaging Catheter and iCross Coronary Imaging Catheter available from Boston Scientific Corporation, the ultrasound transducer is positioned 2.1 cm proximal of a marker band near the distal tip such that the ultrasound transducer is approximately 3 cm proximal of the distal tip of the device. Further, even in the EagleEye® Platinum RX Digital IVUS Catheter available from Volcano Corporation, the transducer array is spaced from the distal tip by a distance of 1 cm. This spacing of the ultrasound transducer(s) from the distal tip of the device is suitable for many vessel visualization applications and evaluations, but has limited effectiveness in the visualization and evaluation of severe occlusions [0010] Accordingly, there remains a need for improved devices, systems, and methods for visualizing vessels having a severe blockage or other restriction to the flow of fluid through the vessel. In that regard, there remains a need for improved devices, systems, and methods for visualizing the severe blockage to facilitate safely crossing the blockage. SUMMARY [0011] Embodiments of the present disclosure are configured to visualize a blockage in a vessel and, in particular, a severe blockage in a blood vessel to facilitate crossing of that blockage. In some instances, devices particularly suited for visualizing a blockage are provided. In that regard, the devices include one or more imaging elements (such as ultrasound, OCT, thermal, and/or other imaging modality) positioned adjacent the distal tip of the device. In some instances, the imaging element(s) are positioned less than 5 mm, less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, and/or less than 0.5 mm from the distal tip of the device. Further, in some implementations the device is a catheter that includes an inner lumen that is sized and shaped to receive a guidewire. In that regard, in some embodiments the catheter is arranged as a rapid-exchange catheter having at least one opening in communication with the central lumen for receiving the guidewire, the opening being positioned between the proximal and distal ends of the catheter. In other embodiments, the catheter is an over-the-wire catheter. [0012] In other instances, methods of crossing a total occlusion of a vessel of a patient are provided. The method includes introducing an imaging device into the vessel of the patient, advancing the imaging device to a position immediately adjacent the total occlusion of the vessel such that a distal tip of the imaging device is in contact with the occlusion and one or more imaging elements (such as ultrasound, OCT, thermal, and/or other imaging modality) of the imaging device are positioned less than 5 mm, less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, and/or less than 0.5 mm from the occlusion. The method further includes obtaining images of the vessel, including the occlusion, with the imaging device positioned immediately adjacent the total occlusion. In some instances, the method further includes penetrating the total occlusion based on the images obtained by the imaging device. In that regard, in some instances an ablation guidewire or other occlusion crossing device is advanced through a central lumen of the imaging device to the occlusion. In some instances, the occlusion is partially penetrated or crossed using the ablation guidewire (e.g., RF, laser, electric, plasma, etc.) or other occlusion crossing device (e.g., needle, etc.), then the imaging device is advanced into the opening created by the partial penetration/crossing and again used to image the vessel, including the occlusion. This process can be repeated to safely guide the ablation guidewire or other occlusion crossing device through the occlusion. [0013] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [0014] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which: [0015] FIG. 1 is a diagrammatic perspective view of an imaging device according to an embodiment of the present disclosure. [0016] FIG. 2 is a diagrammatic perspective view of an imaging device according to another embodiment of the present disclosure. [0017] FIG. 3 is a diagrammatic side view of a distal portion of an imaging device, such as the imaging devices shown in FIGS. 1 and 2 , according to an embodiment of the present disclosure. [0018] FIG. 4 is a close up diagrammatic side view of a distal tip of the distal portion of the imaging device shown in FIG. 3 . [0019] FIG. 5 is a diagrammatic perspective view of an imaging system according to an embodiment of the present disclosure. [0020] FIG. 6 is an isometric view of a side-looking or lateral imaging plane of an imaging device according to an embodiment of the present disclosure. [0021] FIG. 7 is an isometric view of a forward-looking imaging plane of an imaging device according to an embodiment of the present disclosure. [0022] FIG. 8 is an isometric view of a forward-looking imaging plane of an imaging device according to another embodiment of the present disclosure. [0023] FIG. 9 is a diagrammatic, schematic view of an imaging system according to an embodiment of the present disclosure. DETAILED DESCRIPTION [0024] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately. [0025] Referring to FIG. 1 , shown therein is an imaging device 100 according to an embodiment of the present disclosure. As shown, the imaging device 100 comprises an elongate flexible body 102 having a proximal portion 104 and a distal portion 106 . The proximal portion 104 includes an adapter 108 . In the illustrated embodiment, the adapter 108 is y-shaped with extensions 110 and 112 . In that regard, extension 110 generally extends along the longitudinal axis of the body 102 , while extension 112 extends at an oblique angle with respect to the longitudinal axis of the body. Generally, the extensions 110 and 112 provide access to the body 102 . In that regard, in the illustrated embodiment extension 110 is configured to receive a guidewire 114 that is sized and shaped to fit within a lumen that extends along the length of the body 102 from the proximal portion 104 to the distal portion 106 and defines an opening at the distal end of the imaging device 100 . As a result of this arrangement, the imaging device 100 is understood to be what is commonly referred to as an over-the-wire catheter. In some embodiments, the lumen of the imaging device is centered about the central longitudinal axis of the body 102 . In other embodiments, the lumen is offset with respect to the central longitudinal axis of the body 102 . [0026] In the illustrated embodiment, extension 112 of adapter 108 is configured to receive communication lines (e.g., electrical, optical, and/or combinations thereof) that are coupled to imaging components positioned within the distal portion 106 of the imaging device 100 . In that regard, a cable 116 containing one or more communication lines extends from extension 112 to a connector 118 . The connector 118 is configured to interface the imaging device directly or indirectly with one or more of a patient interface module (“PIM”), a processor, a controller, and/or combinations thereof. The particular type of connection depends on the type of imaging components implemented in the imaging device, but generally include one or more of an electrical connection, an optical connection, and/or combinations thereof. [0027] The distal portion 106 includes a plurality of markers 120 . In that regard, the markers 120 are visible using non-invasive imaging techniques (e.g., fluoroscopy, x-ray, CT scan, etc.) to track the location of the distal portion 106 of the imaging device 100 within a patient. Accordingly, in some instances the markers 120 are radiopaque bands extending around the circumference of the body 102 . Further, the markers 120 are positioned at known, fixed distances from an imaging element 122 and/or the distal end 124 of the imaging device 100 in some instances. While the distal portion 106 has been illustrated and described as having a plurality (two or more) of markers 120 , in other embodiments the distal portion 106 includes one marker or no markers. Further, in some embodiments, one or more components associated with the imaging element 122 can be utilized as a marker to provide a reference of the position of the distal portion 106 of the imaging device 100 . [0028] The imaging element 122 may be any type of imaging element suitable for visualizing a vessel and, in particular, a sever occlusion in a vessel. Accordingly, the imaging element may be an ultrasound transducer array (e.g., arrays having 16, 32, 64, or 128 elements are utilized in some embodiments), a single ultrasound transducer, one or more optical coherence tomography (“OCT”) elements (e.g., mirror, reflector, and/or optical fiber), and/or combinations thereof. In that regard, in some embodiments the imaging device 100 is configured to be rotated (either manually by hand or by use of a motor or other rotary device) to obtain images of the vessel. [0029] Referring to FIG. 2 , shown therein is an imaging device 200 according to another embodiment of the present disclosure. As shown, the imaging device 200 comprises an elongate flexible body 202 having a proximal portion 204 and a distal portion 206 . The proximal portion 204 includes a handle 208 for grasping by a user. In the illustrated embodiment, a cable 216 extends from the handle 208 and includes one or more communication lines (e.g., electrical, optical, and/or combinations thereof) that are coupled to imaging components positioned within the distal portion 206 of the imaging device 200 . In that regard, a cable 216 containing one or more communication lines extends from handle 208 to a connector 218 . The connector 218 is configured to interface the imaging device directly or indirectly with one or more of a patient interface module (“PIM”), a processor, a controller, and/or combinations thereof. The particular type of connection depends on the type of imaging components implemented in the imaging device, but generally include one or more of an electrical connection, an optical connection, and/or combinations thereof. [0030] The body 202 includes an opening 210 that is in communication with a lumen that extends along the length of the body 202 from the opening 210 to the distal portion 206 and defines an opening at the distal end of the imaging device 200 . The opening 210 and the lumen it is in communication with are configured to receive a guidewire. As a result of this arrangement, the imaging device 200 is understood to be what is commonly referred to as a rapid exchange catheter. In some embodiments, the lumen of the imaging device is centered about the central longitudinal axis of the body 202 . In other embodiments, the lumen is offset with respect to the central longitudinal axis of the body 202 . [0031] The distal portion 206 includes a plurality of markers 220 . In that regard, the markers 220 are visible using non-invasive imaging techniques (e.g., fluoroscopy, x-ray, CT scan, etc.) to track the location of the distal portion 206 of the imaging device 200 within a patient. Accordingly, in some instances the markers 220 are radiopaque bands extending around the circumference of the body 202 . Further, the markers 220 are positioned at known, fixed distances from an imaging element 222 and/or the distal end 224 of the imaging device 200 in some instances. While the distal portion 106 has been illustrated and described as having a plurality (two or more) of markers 220 , in other embodiments the distal portion 206 includes one marker or no markers. Further, in some embodiments, one or more components associated with the imaging element 222 can be utilized as a marker to provide a reference of the position of the distal portion 206 of the imaging device 200 . [0032] The imaging element 222 may be any type of imaging element suitable for visualizing a vessel and, in particular, a sever occlusion in a vessel. Accordingly, the imaging element may be an ultrasound transducer array (e.g., arrays having 16, 32, 64, or 128 elements are utilized in some embodiments), a single ultrasound transducer, one or more optical coherence tomography (“OCT”) elements (e.g., mirror, reflector, and/or optical fiber), and/or combinations thereof. In that regard, in some embodiments the imaging device 200 is configured to be rotated (either manually by hand or by use of a motor or other rotary device) to obtain images of the vessel. [0033] Referring now to FIGS. 3 and 4 , shown therein is a distal portion 300 of an imaging device according to an embodiment of the present disclosure. In that regard, the illustrated arrangement of the distal portion 300 is suitable for use in both over-the-wire catheters (e.g., imaging device 100 of FIG. 1 ) and rapid exchange catheters (e.g., imaging device 200 of FIG. 2 ). As shown, the distal portion 300 includes a main body 302 the contains imaging components 304 , which may include various electronic, optical, and/or electro-optical components necessary for the particular imaging modality utilized by the imaging device. In the illustrated embodiment, the distal portion 300 of the imaging device is configured for ultrasound imaging and includes an array 306 of ultrasound transducers arranged circumferentially about the distal portion 300 of the imaging device. In that regard, in some embodiments the transducer array 306 and associated components 304 include features as disclosed in U.S. Pat. No. 5,857,974 to Eberle et al. that issued Jan. 12, 1999, U.S. Pat. No. 6,283,921 to Nix et al. that issued on Sep. 4, 2001, U.S. Pat. No. 6,080,109 to Baker et al. that issued on Jun. 27, 2000, U.S. Pat. No. 6,123,673 to Eberle et al. that issued on Sep. 26, 2000, U.S. Pat. No. 6,457,365 to Stephens et al. that issued on Oct. 1, 2002, U.S. Pat. No. 7,762,954 to Nix et al. that issued on Jul. 27, 2010, U.S. Pat. No. 7,846,101 to Eberle et al. that issued on Dec. 7, 2010, and U.S. Patent Application Publication No. 2004/0054287 that published on Mar. 18, 2004, each of which is hereby incorporated by reference in its entirety. [0034] As shown, the main body 302 of the distal portion 300 has a diameter or thickness 308 . Generally, the diameter or thickness 308 of the distal portion 300 closely matches the diameter of the main body of the imaging device. In some instances, the diameter or thickness 308 of the distal portion 300 exactly matches the diameter of the main body of the imaging device. In other instances, the diameter or thickness 308 of the distal portion 300 is slightly larger or slight smaller than the diameter of the main body of the imaging device. In some instances, the diameter or thickness 308 is between about 0.5 mm and about 5 mm, with some particular embodiments having a diameter or thickness of 2.73 mm (8.2 French), 2.33 mm (7 French), 1.17 mm (3.5 French), 1.1 mm (3.3 French), 1.0 mm (3 French), 0.97 mm (2.9 French), or otherwise. [0035] The distal portion 300 also includes a tapered tip portion 310 that extends distally from the main body 302 to the distal end 312 . As shown, the tapered tip portion 310 transitions the distal portion 300 from the diameter or thickness 308 to a reduced diameter or thickness 314 at the distal end 312 . In some instances, the diameter or thickness 314 is between about 0.30 mm and about 2.5 mm, with some particular embodiments having a diameter or thickness of 0.30 mm (0.012″ or 0.9 French), 0.38 mm (0.015″ or 1.14 French), 0.48 mm (0.019″ or 1.44 French), or otherwise. In that regard, the diameter or thickness 314 is determined based on the desired lumen size for the imaging device in some instances. For example, as shown in FIGS. 3 and 4 a guidewire 114 is received within the lumen of the imaging device such that it extends through an opening in the distal end 312 of the imaging device. In some particular instances, the guidewire 114 has an outer diameter between about 0.28 mm (0.011″ or 0.84 French) and about 0.46 mm (0.018″ or 1.38 French) mm, with some embodiments having an outer diameter of 0.36 mm (0.014″ or 1.07 French). In other instances, the guidewire 114 has outer diameter outside of this range, either larger or smaller. As the distal end 312 of the imaging device defines the opening that receives the guidewire, the diameter or thickness 314 is between 0.28 mm (0.011″ or 0.84 French) and about 0.5 mm (0.020″ or 1.5 French) in some embodiments. In that regard, it is understood that the distal end 312 of the imaging device will necessarily have a slightly larger diameter or thickness than that of the guidewire 114 such that the guidewire can be received therein. However, in some instances the diameter or thickness 314 of the distal end 312 of the imaging device is within 0.03 mm (0.001″ or 0.09 French) or less of the outer diameter of the guidewire. In other instances, the diameter or thickness 314 of the distal end 312 of the imaging device is within 0.5 mm (0.020″ or 1.5 French) or less of the outer diameter of the guidewire. [0036] As shown, the tapered tip portion 310 of the imaging device extends proximal of the distal end 312 by a distance 316 . In that regard, the distance 316 is less than 5 mm in some embodiments. Further, the distance 316 is less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, and/or less than 0.5 mm from the distal end 312 of the device in some instances. The distance 316 and the difference between the diameter or thickness 308 of the main body 302 and the diameter or thickness 314 at the distal end 312 determine the slope of the outer surface defined by the tapered tip portion 310 . In that regard, in some embodiments the tapered tip portion 310 includes a constant taper between the diameter or thickness 308 of the main body 302 at the proximal end of the tapered tip portion and the diameter or thickness 314 at the distal end 312 of the tapered tip portion. In other instances, the tapered tip portion 310 includes a variable taper between the diameter or thickness 308 of the main body 302 at the proximal end of the tapered tip portion and the diameter or thickness 314 at the distal end 312 of the tapered tip portion. For example, in some instances the degree of taper decreases as the tapered tip portion 310 extends distally towards the distal end 312 . [0037] Referring now to FIG. 5 , there is shown a catheter 400 for intravascular use, which may be similar to either of imaging devices 100 and 200 discussed above. In that regard, this catheter has an elongated flexible body 402 with an axially extending lumen 404 through which a guide wire 406 , fluids, and/or various therapeutic devices or other instruments can be passed. The present disclosure is not, however, limited to use with the illustrated catheter arrangements, and it can be utilized with any suitable catheter, guide wire, probe, etc. An ultrasonic imaging transducer assembly 408 is provided at the distal portion 410 of the catheter, with a connector 424 located at the proximal end of the catheter. This transducer 408 comprises a plurality of transducer elements 412 that are preferably arranged in a cylindrical array centered about the longitudinal axis 414 of the catheter for transmitting and receiving ultrasonic energy. The transducer elements 412 are mounted on a cylindrical substrate 416 which, in the embodiment illustrated, consists of a flexible circuit material that has been rolled into the form of a tube. A transducer backing material with the proper acoustical properties surrounds the transducer elements 412 . [0038] Each of the transducer elements 412 comprises an elongated body of PZT or other suitable piezoelectric material. The elements extend longitudinally on the cylindrical substrate and parallel to the axis of the catheter. Each element has a rectangular cross-section, with a generally flat surface at the distal end thereof. The transducer elements are piezoelectrically poled in one direction along their entire length as highlighted. In some embodiments, a transversely extending notch of generally triangular cross-section is formed in each of the transducer elements. The notch opens through the inner surface of the transducer element and extends almost all the way through to the outer surface. Preferably, the notch has a vertical sidewall on the distal side and an inclined sidewall on the proximal side. The vertical wall is perpendicular to the longitudinal axis of the catheter, and the inclined wall is inclined at an angle on the order of 60 degrees to the axis. The notch, which exists in all the array transducer elements, can be filled with a stable non-conductive material. An example of a material that can be used to fill notch is a non-conductive epoxy having low acoustic impedance. Although not the preferred material, conductive materials having low acoustic impedance may also be used to fill notch. If a conductive material is used as the notch filler, it could avoid having to metalize the top portion to interconnect both portions of the transducer elements as required if a nonconductive material is utilized. Conductive materials are not the preferred notch filler given that they have an affect on the E-fields generated by the transducer elements. [0039] In the preferred embodiment, the transducer array provides for a forward looking elevation aperture for 10 mega Hertz (MHz) ultrasound transmit and receive, and a side looking elevation aperture for 20 MHz ultrasound transmit and receive. Other frequencies and/or frequency combinations can be used depending on the particular design requirements or intended uses for the imaging device. The transducer array is manufactured by electrically and mechanically bonding a poled, metalized block of the piezoelectric material to the flexible circuit substrate with the substrate in its unrolled or flat condition. The transducer block exists, as a piezoelectrically poled state where the thickness-axis poling is generally uniform in distribution and in the same axis throughout the entire block of material. If included, a notch is then formed across the entire piezoelectric block, e.g. by cutting it with a dicing saw. Each of the individual notches is filled with a material such as plastic and a metallization is applied to the top of the notch to form a continuous transducer inner electrode with metallization. The block is then cut lengthwise to form the individual elements that are isolated from each other both electrically and mechanically, with kerfs formed between the elements. Cable wire attachment terminals are provided on the substrate that allow microcables that are electrically connected to an external ultrasound system to connect with the transducer assembly in order to control the transducers. [0040] Integrated circuits are installed on the substrate and the substrate is then rolled into its cylindrical shape, with the transducer elements on the inner side of the cylinder. The sleeve of radiopaque material is mounted on the core, the core is positioned within the cylinder, and the acoustic absorbing material is introduced into the volume between the core and the transducer elements. In the event that a radiopaque marker is not required for a particular application, it can be omitted. The transducer elements 412 can be operated to preferentially transmit and receive ultrasonic energy in either a thickness extensional TE) mode (k 33 operation) or a length extensional (LE) mode (k 31 operation). The frequency of excitation for the TE mode is determined by the thickness of the transducer elements in the radial direction, and the frequency for the LE mode is determined by the length of the body between distal end surface and the vertical wall of notch. The thickness TE mode is resonant at a frequency whose half wavelength in the piezoelectric material is equal to the thickness of the element. And the LE mode is resonant at a frequency whose half wavelength in the piezoelectric material is equal to the distance between the distal end and the notch. Each transducer element is capable of individually operating to transmit and receive ultrasound energy in either mode, with the selection of the desired mode (i.e. “side”, or “forward”) being dependent upon; a) an electronically selected frequency band of interest, b) a transducer design that spatially isolates the echo beam patterns between the two modes, and c) image plane specific beam-forming weights and delays for a particular desired image plane to reconstruct using synthetic aperture beam-forming techniques, where echo timing incoherence between the “side” and “forward” beam patterns will help maintain modal isolation. [0041] Referring now to FIGS. 6-8 , shown therein are various imaging planes that are utilized in some embodiments of the devices and methods of the present disclosure. In that regard, some of the ultrasonic imaging catheters of the present disclosure are configured to be “side looking” devices that produce B-mode images in a plane that is perpendicular to the longitudinal axis of the catheter and passes through the transducer. That plane can be referred to as the B-mode lateral plane and is illustrated in FIG. 6 . Further, some of the ultrasonic imaging catheters of the present disclosure are configured to be “forward looking” devices that produce a C-mode image plane that is perpendicular to the axis of the catheter and spaced distally from the transducer array, which is illustrated in FIG. 7 . Further still, some of the ultrasonic imaging catheters of the present disclosure are configured to be “forward looking” devices that produce a B-mode image in a plane that extends in a forward direction from the transducer and parallel to the axis of the catheter. That imaging plane is referred to as the B-mode forward plane and is illustrated in FIG. 8 . Forward viewing devices can be particularly advantageous in some crossing severe occlusions as they allow the physician to see aspects of the occlusion in front of the catheter. Finally, some of the ultrasonic imaging catheters of the present disclosure are configured to transition between two or more of the imaging planes shown in FIGS. 6-8 . The following discusses ways these multiple modes of imaging can be implemented. It is understood that some embodiments of the present disclosure implement only a single one of these imaging modes. Further, it is understood that any suitable operating frequencies may be utilized for the different imaging modes, including frequencies between 10 MHz and 80 MHz, including without limitation 10 MHz, 20 MHz, 40 MHz, and 80 MHz. The forward-looking imaging modes described below utilize a 20 MHz operating frequency in some instances. [0042] Multiple Modes of Imaging: Explanation of the Principals of Operation [0043] A piezoelectric transducer, when properly excited, will perform a translation of electrical energy to mechanical energy, and as well, mechanical to electrical. The effectiveness of these translations depends largely on the fundamental transduction efficiency of the transducer assembly taken as a whole. The transducer is a three dimensional electromechanical device though, and as such is always capable of some degree of electromechanical coupling in all possible resonate modes, with one or several modes dominating. Generally an imaging transducer design seeks to create a single dominate mode of electromechanical coupling, suppressing all other coupling modes as “spurious.” The common method used to accomplish a transducer design with a single dominate mode of electromechanical coupling usually rests in the creation of a single, efficient mechanical coupling “port” to the medium outside of the transducer. The single port is created by mounting the transducer such that the most efficient resonant mode of transducer operation faces that mechanical coupling port, with all other modes suppressed by means of mechanical dispersion attained by transducer dimensional control and dampening materials. [0044] In the design of the present disclosure, the transducer design utilizes the fact that a transducer can be effective in two principal electromechanical coupling modes, each mode using a different frequency of operation, acoustic “port”, and electro-mechanical coupling efficiency. One port is the “side looking” port that is used in the cross-sectional view image (as shown in FIG. 6 ). The other port is the “end” or “forward looking” port of the array (as shown in FIGS. 7 and 8 ). [0045] The present disclosure allows the two electromechanical coupling modes (i.e. “side” and “forward”) to be always active, without any mechanical switching necessary to choose one mode exclusive of the other. This design also assures that echoes of any image target in the “side looking” plane (see FIG. 6 ) do not interfere with the target reconstruction in the “forward looking” planes (see FIGS. 7 and 8 ), and reciprocally, image targets from the “forward looking” do not interfere with the target reconstruction in the “side looking” planes. In accordance with the disclosure, the design methods listed below are used to maintain sufficient isolation between the two modes of operation. [0046] A) Resonant and Spatial Isolation of the Two Modes [0047] In some instances, the “side looking” port is designed for approximately twice the frequency of the “forward looking” port in accordance with the preferred embodiment. The transducer dimensional design is such that the “high frequency and side looking” transducer port sensitivity to low frequency signals, and as well the “low frequency and forward looking” transducer port to high frequency signals, is very low. [0048] Additionally, the transmit and receive acoustic “beam” directions of the two modes are at approximately right angles to each other and this feature offers an additional isolation with respect to image target identification. Also, as a means to further promote isolation between the two modes of operation, and as well optimize a sparse array echo collection method, the echo collection process in “forward” beam reconstruction uses an intentional physical separation of transmitting and receiving transducer elements of preferably 10 elements or more in the circular array annulus. This physical separation aids in preventing “spurious” transmit echoes from the “high frequency side looking” port from contaminating the receiving element listening to “forward only” echoes at the its lower frequency of operation. [0049] B) Electrical Frequency Band Isolation of the Two Modes [0050] As stated previously, the two modes of operation are operated at center frequencies that differ by about a factor of two. This design feature allows for additional isolation between the two modes through the use of band pass filters in the host system that is processing the echo signals received from the catheter. Additionally, if one or both of the two modes is operated in a low fractional bandwidth design (i.e. <30%), the bandpass filters will be even more effective in the maintenance of very high modal isolation. [0051] C) Beam Formation Isolation Through Synthetic Aperture Reconstruction [0052] Synthetic aperture beam reconstruction is used for all image modes. The beam formation process will preferentially focus only on image targets that are coherently imaged in a particular image plane. Thus, while image reconstruction is forming an image in, for example, the “side looking” plane, targets that may have contaminated the echoes from the “forward looking” planes will be generally incoherent and will be suppressed as a type of background noise. The reciprocal is also true: “side looking” echoes contaminants will be generally incoherent in “forward looking” imaging and will be suppressed through the process of synthetic aperture reconstruction. [0053] A flexible digital image reconstruction system is required for the creation of multiple image planes on demand. The preferred method of assembling multiple image planes utilizes a synthetic aperture reconstruction approach. The “side looking” image shown in FIG. 1 can be reconstructed using sampled transducer element apertures as large as for example 14 contiguous transducer elements in a 64 total transducer element circular array. The transmit-receive echo collection for aperture reconstruction can be continuously shifted around the circular array, sampling all transmit-receive cross-product terms to be used in a particular aperture reconstruction. Within any 14-element aperture there can be 105 independent transmit-receive echo cross products used to construct the image synthetically. [0054] “Forward looking” images shown in FIGS. 7 and 8 can be reconstructed using sampled apertures that consist of selected transducer elements arranged on the annulus end of the circular array. For the 64 transducer element example mentioned above, all elements may contribute to a complete data set capture (this would consist of 64 by 32 independent transmit-receive element cross-products) to form a “forward looking” image in either C-mode or B-mode. As an alternative to the complete data set approach, a reduced number of independent transmit-receive element cross-products are used to adequately formulate the image. The transmit-receive echo collection for aperture reconstruction can be continuously shifted around the circular array, sampling all transmit-receive element cross-products to be used in a particular aperture reconstruction. [0055] Special signal processing may be advantageous, especially in the “forward looking” imaging modes that use a less efficient transducer coupling coefficient (k 31 ) and as well may suffer from additional diffraction loss not experienced in the “side looking” mode of synthetic aperture imaging. In forming a “forward looking” C-mode image plane as an example, a low noise bandwidth can be achieved by using a high number of transmit pulses and a narrow bandpass echo filter in the processing system. Additionally, or as a preferred alternative, a matched filter implementation from the use of correlation processing may be used to improve the echo signal-to-noise ratio. [0056] Standard Cross-Sectional B-Mode Operation [0057] The advantage of this cross-sectional B-mode operation of the catheter imaging device is in its ability to see an image at great depth in the radial dimension from the catheter, and at high image resolution. This depth of view can help aid the user of the catheter to position the device correctly prior to electronically switching to a “forward viewing” mode of operation. Image targets moving quickly in a path generally parallel to the long axis of the catheter can be detected and displayed as a colored region in this mode; this information can be used to compare and confirm moving target information from the “forward viewing” mode of operation of the catheter to enhance the usefulness of the imaging tool. [0058] 1. Transducer Operation [0059] The transducer in this “primary” mode operates in the thickness extensional (TE) resonance, utilizing the k 33 electro-mechanical coupling coefficient to describe the coupling efficiency. This “thickness resonance” refers to a quarter wave or half wave (depending on the acoustic impedance of the transducer backing formulation) resonance in the transducer dimension that is in alignment with the polarization direction of the transducer, and also the sensed or applied electric field. This TE mode utilizes a typically high frequency thickness resonance developed in the transducer short dimension following either electric field excitation to generate ultrasound acoustic transmit echoes, or, in reception mode following acoustic excitation to generate an electric field in the transducer. [0060] Array Stepping [0061] The TE mode is used for generating a cross-sectional B-mode image. This cross-section image cuts through the array elements in an orthogonal plane to the long axis of the transducer elements. Echo information gathered from sequential transducer element sampling around the array allows for the synthetically derived apertures of various sizes around the array. For the creation of any synthetically derived aperture, a contiguous group of transducer elements in the array are sequentially used in a way to fully sample all the echo-independent transmit-receive element pairs from the aperture. This sequencing of elements to fully sample an aperture usually involves the transmission of echo information from one or more contiguous elements in the aperture and the reception of echo information on the same or other elements, proceeding until all the echo independent transmit-receive pairs are collected. [0062] Notch Effect [0063] The small notch forming an acoustical discontinuity in the middle of the array of some embodiments will have a minor, but insignificant effect on the TE mode transmission or reception beam pattern for that element. The small notch will be a non-active region for the TE mode resonance and therefore contribute to a “hole” in the very near field beam pattern for each element. The important beam characteristics however, such as the main lobe effective beam width and amplitude, will not be substantially affected, and except for a very minor rise in the transducer elevation side lobes, reasonable beam characteristics will be preserved as if the entire length of the transducer element was uniformly active. [0064] Modal Dispersion [0065] The TE mode transducer operation will exist with other resonant modes simultaneously. The efficiency of electromechanical energy coupling however for each mode though depends on primarily these factors: a) the k coefficient that describes the energy efficiency of transduction for a given resonance node, b) the acoustic coupling path to the desired insonification medium, and c) the echo transmission-reception signal bandwidth matching to the transducer resonance for that particular mode. Thus, for the creation of a “side looking” image, a transducer design is created to optimize the factors above for only the TE resonance, while the other resonant modes within a transducer are to be ignored through the design which suppresses the undesired resonances by minimizing the energy coupling factors mentioned above. [0066] Through this frequency dispersion of unwanted coupling, the desired echoes transmitted and received from the “side looking” transducer port necessary to create a B-mode image plane will be most efficiently coupled through the TE resonance mode within any particular element. Therefore, the proposed transducer design which features a high efficiency TE mode coupling for desired echoes and frequency dispersion of the unwanted resonances and echoes, along with the other modal isolation reasons stated in an earlier section, constitutes a means for high quality TE echo energy transduction for only those desired in-plane echoes used in the creation of the B-mode cross-sectional image plane. [0067] 2. System operation for the Standard Cross-Sectional B-Mode Imaging [0068] The host ultrasound processing system shown in FIG. 9 controls the ultrasound array 408 element selection and stepping process whereby a single element 412 or multiple elements will transmit and the same or other elements will receive the return echo information. The elements in the array that participate in a given aperture will be sampled sequentially so that all essential cross product transmit-receive terms needed in the beam forming sum are obtained. [0069] The host processing system or computer 914 and reconstruction controller 918 will control the transmit pulse timing provided to wideband pulser/receiver 902 , the use of any matched filter 910 via control line 916 to perform echo pulse compression. The echo band pass filter (BPF) processing paths in the system are selected using control signal 906 to select between either the 10 MHz 904 or 20 MHz 936 center frequency BPF paths. The amplified and processed analog echo information is digitized using ADC 908 with enough bits to preserve the dynamic range of the echo signals, and passed to the beam-former processing section via signal 912 . The beam former section under the control of reconstruction controller 918 uses stored echo data from all the transmit-receive element pairs that exist in an aperture of interest. As the element echo sampling continues sequentially around the circular array, all element group apertures are “reconstructed” using well known synthetic aperture reconstruction techniques to form beam-formed vectors of weighted and summed echo data that radially emanate from the catheter surface using beam-former memory array 922 , devices 924 and summation unit 926 . Memory control signal 920 controls switch bank 924 which selects which memory array to store the incoming data. [0070] The vector echo data is processed through envelope detection of the echo data and rejection of the RF carrier using vector processor 928 . Finally a process of coordinate conversion is done to map the radial vector lines of echo data to raster scan data using scan converter 930 for video display using display 932 . [0071] This processing system, through the host control, may also accomplish blood velocity detection by tracking the blood cells through the elevation length of the transducer beams. The tracking scheme involves a modification of the element echo sampling sequencing and the use of the beam-former section of the host processing system. The blood velocity information may be displayed as a color on the video display; this blood velocity color information is superimposed on the image display to allow the user to see simultaneous anatomical information and blood movement information. [0072] Forward Looking Cross-Sectional C-Mode Operation [0073] The advantage of this “forward looking” operation of the catheter imaging device is in its ability to see an image of objects in front of the catheter where possibly the catheter could not otherwise physically traverse. A “forward” C-mode plane produces a cross-sectional view similar to the standard B-mode cross-sectional view, and so can offer comparable image interpretation for the user, and as well this forward image plane is made more useful because the user can see the presence of image targets at the center of the image, otherwise obscured in the standard cross-sectional view by the catheter itself. This forward view allows also the ideal acoustic beam positioning for the detection and color image display of Doppler echo signals from targets moving generally in parallel with the long axis of the catheter device. [0074] 1. Transducer Operation [0075] The transducer in this “secondary” mode operates in the length extensional (LE) resonance, utilizing the k 31 electromechanical coupling coefficient to describe the coupling efficiency. In this mode of operation, the poling direction of the transducer element and the sensed or applied electric field in the transducer are in alignment, but the acoustic resonance is at 90 degrees to the electric field and poling direction. This “length resonance” refers fundamentally to a half wave resonance in the transducer element's length dimension that is at 90 degrees with the polarization direction of the transducer. The LE mode of resonance, which is typically much lower in resonant frequency than the TE mode because the element length is normally much longer than the thickness dimension, always exists to some extent in a typical transducer array element, but is usually suppressed through a frequency dispersive design. [0076] Some embodiments of the present disclosure utilize an abrupt physical discontinuity (a notch) in the transducer element to allow a half wave LE resonance to manifest itself at a desired frequency, in the case of the preferred embodiment, at about one half the frequency of the TE mode resonance. A unique feature of this disclosure is a mechanically fixed transducer design that allows two resonant modes to operate at reasonably high efficiencies, while the “selection” of a desired mode (i.e. “side”, or “forward”) is a function of a) an electronically selected frequency band of interest, b) a transducer design that spatially isolates the echo beam patterns between the two modes, and c) image plane specific beam-forming weights and delays for a particular desired image plane to reconstruct using synthetic aperture beam-forming techniques, where echo timing incoherence between the “side” and “forward” beam patterns will help maintain modal isolation. [0077] As discussed earlier, a resonant mode in a transducer design can be made efficient in electromechanical energy coupling if at least the three fundamental factors effecting coupling merit are optimized, namely a) the k coefficient (in this case it is the k 31 electro-mechanical coupling coefficient) that describes the energy efficiency of transduction for a given resonance node, b) the acoustic coupling path to the desired insonification medium, and c) the echo transmission-reception signal bandwidth matching to the transducer resonance for that particular mode. The disclosure allows for reasonable optimization of these factors for the LE mode of resonance, although the LE mode coupling efficiency is lower than that of the TE mode coupling. The k 31 coupling factor, used in describing LE mode efficiency, is typically one half that of k 33 , the coupling factor that describes the TE mode efficiency. [0078] The abrupt acoustical discontinuity in the transducer element is created at a step in the assembly of the array. Following the attachment of the transducer material to the flex circuit to create a mechanical bond and electrical connection between the transducer block and the flex circuit, while the transducer material is still in block form, a dicing saw cut can be made the entire length of the transducer material block, creating the notch. The notch depth should be deep enough in the transducer material to create an abrupt discontinuity in the distal portion of the transducer material to allow for a high efficiency LE mode half wave resonance to exist in this end of the transducer element. The saw cut should not be so deep as to sever the ground electrode trace on the transducer block side bonded to the flex circuit. The cut should ideally have a taper on the proximal side to allow for acoustically emitted energy to be reflected up into the backing material area and become absorbed. [0079] Generally, it is not desirable to have any acoustic coupling exist between the LE modes of resonance in the distal and proximal transducer regions separated by the notch. The distal transducer region LE mode half wave resonance will exist at 10 MHz in PZT (Motorola 3203HD) for a length of about 170 microns between the distal end of the transducer element and the notch. The proximal transducer region LE mode resonance will exist at a frequency considered out of band (approximately 6 MHz) in the two embodiments shown in FIGS. 5 and 7 so as to minimally interfere with the desired operating frequencies (in this case 10 MHz LE mode resonance in the distal region for “forward” acoustic propagation, and 20 MHz TE mode resonance in the entire active field length of the transducer). [0080] The desired acoustic energy coupling port of the distal transducer LE resonant mode region is at the distal end of the catheter array. To protect the end of the array and potentially act as an acoustic matching layer, an end cap made of polyurethane could be used, or alternatively, a uniform coating of adhesive material would suffice. The beam pattern produced by this acoustic port must be broad enough to insonify a large area that covers intended extent of the image plane to be formed. To this end, the beam pattern must typically be at least 60 degrees wide as a “cone shaped” beam measured in the plane to be formed at the half-maximum intensity angles for 2-way (transmitted and received) echoes. The preferred design of the array has 64 or more elements, and a transducer sawing pitch equal to pi times the catheter array diameter divided by the number of elements in the array. For an effective array diameter of 1.13 mm and 64 elements, the pitch is 0.055 mm. Using two consecutive array elements as a “single” effective LE mode acoustic port can provide an adequate, uniform beam pattern that produces the required 60-degree full-width half maximum (“FWHM”) figure of merit. The aperture of this “single” forward looking port is then approximately 0.080 mm by 0.085 mm (where 0.085 mm is twice the pitch dimension minus the kerf width of 0.025 mm). [0081] The transducer design may also include a version where no notch is needed in the transducer block. In this case, the driven electrode can exist all along one surface of the transducer element, and the ground or reference electrode can exist all along the opposite side of the element. The long axis length of the transducer will resonate at a half wavelength in LE mode, and the thickness dimension will allow the production of a TE mode resonance in that thickness dimension. In order for this design to operate though, the LE and TE mode resonant frequencies will be quite different in order to maintain the proper TE mode elevation beam focus. As an example, in maintaining the length of the active region of the element for an adequately narrow 20 MHz TE mode elevation beam width at 3 mm radially distant from the catheter, the element length should be approximately 0.5 mm long. The resulting half wave resonance frequency in LE mode then will be about 3 MHz. This design can be used for dual-mode imaging, but will not offer the focusing benefits that 10 MHz imaging can offer for the forward looking image planes. Other designs are possible, where the forward frequency is maintained near 10 MHz, but the required frequency for the side-looking mode will rise dramatically, and although this can be useful in itself, will complicate the design by requiring a concomitant increase in the number of elements and/or a reduction in the array element pitch dimension. [0082] 2. System Operation [0083] The host processing system will control the array element selection and stepping process whereby one element, a two element pair, or other multiple elements in combination, will transmit and the same or other elements will receive the return echo information. The intended array operational mode is the LE resonant mode to send and receive echo information in a forward direction from the end of the catheter array. As stated earlier, the LE mode echoes produced may be isolated from the TE mode echoes through primarily frequency band limitations (both by transducer structural design and by electrical band selection filters), and through the beam-forming reconstruction process itself as a kind of echo selection filter. [0084] To produce an image of the best possible in-plane resolution while operating in the forward-looking cross-sectional C-mode, the entire array diameter will be used as the maximum aperture dimension. This means that, in general, element echo sampling will take place at element locations throughout the whole array in preferably a sparse sampling mode of operation to gather the necessary minimum number of cross-product echoes needed to create image resolution of high quality everywhere in the reconstructed plane. [0085] By using transmit-receive echo contributions collected from elements throughout the whole catheter array, using either a “complete data set” (e.g. 64×32), or a sparse sampling (e.g. less than 64×32) of elements, the FWHM main beam resolution will be close to the 20 MHz resolution of the “side looking” cross-sectional image. This is due to the fact that although the “forward looking” echo frequency is about one half as much as the “side looking” frequency, the usable aperture for the forward looking mode is about 1.6 times that of the largest side looking aperture (i.e. the largest side looking aperture is about 0.7 mm, and the forward aperture is about 1.15 mm). For a 10 MHz forward looking design, the FWHM main lobe resolution in an image plane reconstructed at a depth of 3 mm will be approximately 0.39 mm, and 0.65 mm resolution at 5 mm distance. [0086] Due to the limitation of beam diffraction available in the design using 10 MHz as the echo frequency for “forward looking”, the C-mode image diameter that can be reconstructed and displayed with a high level of resolution from echo contributions throughout the whole array will be related to the distance between the reconstructed C-mode image plane and the distal end of the catheter. At 3 mm from the end of the catheter, the C-mode image diameter will be about 2.3 mm, at 5 mm distance the image diameter will be 4.6 mm, and at 7 mm distance the image diameter will be 6.9 mm. [0087] The host processing system, in addition to the control of the transducer element selection and stepping around the array, will control the transmit pulse timing, the use of any matched filter to perform echo pulse compression, and the echo band pass filter processing path in the system. The amplified and processed analog echo information is digitized with enough bits to preserve the dynamic range of the echo signals, and passed to the beam-former processing section. The beam former section uses stored echo data from the sparse array sampling (or alternatively the whole complete array echo data set of 64.times.32 of transmit-receive element pairs) that exist in an aperture of interest. As the element echo sampling continues sequentially around the circular array 1108 as shown in FIGS. 10 and 11 , a number of “full trips” around the array will have been made to collect a sufficient number of echo cross-products (up to 105 in the preferred sparse sampling method) to allow the reconstruction of one image vector line 1102 . As cross-product sampling continues around the array, the “older” echo cross-product collections are replaced with new samples and the next image vector is formed. This process repeats through an angular rotation to create new image vectors while sampling their element cross-product contributors around the array. In the same manner as described in the processing of the “side looking” image, the vector echo data is processed through envelope detection of the echo data and rejection of the RF carrier. Finally a process of coordinate conversion is done to map the radial vector lines of echo data to raster scan data for video display. [0088] This processing system, through the host control, may also accomplish “forward looking” target (such as blood cells) velocity detection by either correlation-tracking the targets along the “forward looking” direction (with processing as earlier discussed with the “side looking” approach), or by standard Doppler processing of echo frequency shifts that correspond to target movement in directions parallel with the “forward looking” echo paths. The target (e.g. blood) velocity information may be displayed as a color on the video display; this velocity color information is superimposed on the image display to allow the user to see simultaneous anatomical information and target movement information. [0089] Forward Looking Sagittal-Sectional B-Mode Operation [0090] The advantage of the “forward looking” operation of the catheter imaging device is in its ability to see an image of objects in front of the catheter where possibly the catheter could not otherwise physically traverse. “Forward” B-mode plane imaging produces a cross-sectional planar “sector” view (see FIG. 8 ) that can exist in any plane parallel to the catheter central axis and distal to the end of the catheter array. This imaging mode may be used, in addition, to produce image “sector” views that are tilted slightly out of plane (see FIG. 8 ), and as well, may produce individual or sets of image “sectors” rotated generally about the catheter axis to allow the user to see a multitude of forward image slices in a format that shows clearly the multidimensional aspects of the forward target region of interest. This forward B-mode imaging (as with C-mode plane imaging) utilizes the ideal acoustic beam positioning for the detection and color image display of Doppler echo signals from targets moving generally in parallel with the long axis of the catheter device. [0091] 1. Transducer Operation [0092] The transducer operation in creating the “forward looking” B-mode image format is virtually the same as discussed earlier for creating the “forward looking” C-mode image. The transducer in this “secondary” mode operates in the length extensional (LE) resonance, utilizing the k 31 electromechanical coupling coefficient to describe the coupling efficiency. As with the C-mode image creation, the number of elements used at any time to form a wide beam pointing in the “forward” direction are selected to produce a required 60 degree FWHM beam width performance; the modal isolation techniques mentioned earlier against the higher frequency TE resonances are valid as well for this forward B-mode imaging method. [0093] However, where it is merely preferred to operate the “forward” C-mode imaging with high bandwidth echo signals (low bandwidth echo signals can also be used, but with some minor loss in image resolution), it is a requirement in the “forward” B-mode imaging that only high bandwidth echo signals (echo fractional bandwidth greater than 30%) be used to preserve the “axial” resolution in the “forward” B-mode image. The lateral resolution in the “forward” B-mode image is determined (as the C-mode image plane resolution) by the aperture (diameter of the array) used for the image reconstruction. The lateral resolution performance will be as stated earlier (i.e. from the description of the C-mode imaging case) for various depths from the catheter distal end. [0094] 2. System Operation [0095] The system operation in creating the “forward looking” B-mode image format is largely the same as discussed earlier for creating the “forward looking” C-mode image, with the difference being in the use of the echo signals collected in the beam-forming process to create, rather than a C-mode image plane, a “forward” sagittal B-mode image in a plane that effectively cuts through the center of the circular array at the distal end of the catheter. [0096] The host processing system, as shown in FIG. 9 , will control the array element selection and stepping process whereby one element, a two element pair, or other multiple elements in combination, will transmit and the same or other elements will receive the return echo information. The intended array operational mode is the LE resonant mode to send and receive echo information in a forward direction from the end of the catheter array. As stated earlier, the LE mode echoes produced may be isolated from the TE mode echoes through primarily frequency band limitations (both by transducer structural design and by electrical band selection filters), and through the beam-forming reconstruction process itself as a kind of echo selection filter. [0097] To produce an image of the best possible in-plane resolution while operating in the “forward looking” sagittal B-mode, the entire array diameter will be used as the maximum aperture dimension. This means that, in general, element echo sampling will take place at element locations throughout the whole array in preferably a sparse sampling mode of operation to gather the necessary minimum number of cross-product echoes needed to create image resolution of high quality everywhere in the reconstructed plane. By using transmit-receive echo contributions collected from elements throughout the whole catheter array, using either a “complete data set” (e.g. 64×32), or a sparse sampling (e.g. less than 64×32) of elements, the FWHM main beam lateral resolution in the B-mode plane will be close to the 20 MHz resolution of the “side looking” cross-sectional image. Similarly, as stated earlier for the C-mode image case, in the creation of the B-mode image using a 10 MHz forward looking design, the FWHM main lobe lateral resolution in the image plane reconstructed at a depth of 3 mm will be approximately 0.39 mm, and 0.65 mm resolution at 5 mm distance. [0098] Due to the limitation of beam diffraction available in the design using 10 MHz as the echo frequency for “forward looking”, the B-mode sector image width that can be reconstructed and displayed with a high level of resolution from echo contributions throughout the whole array will be related to the distance between the reconstructed B-mode target depth in the image sector and the distal end of the catheter. At 3 mm from the end of the catheter, the B-mode image sector width will be about 2.3 mm, at 5 mm distance the image sector width will be 4.6 mm, and at 7 mm distance the image sector width will be 6.9 mm. [0099] The host processing system, in addition to the control of the transducer element selection and stepping around the array, will control the transmit pulse timing, the use of any matched filter to perform echo pulse compression, and the echo band pass filter processing path in the system. The amplified and processed analog echo information is digitized with enough bits to preserve the dynamic range of the echo signals, and passed to the beam-former processing section. The beam former section uses stored echo data from the sparse array sampling (or alternatively the whole complete array echo data-set of 64.times.32 of transmit-receive element pairs) that exist in an aperture of interest. As the element echo sampling continues sequentially around the circular array, a number of “full trips” around the array will have been made to collect a sufficient number of echo cross-products (up to 105 in the preferred sparse sampling method) to allow the reconstruction of one image vector line. As cross-product sampling continues around the array, the “older” echo cross-product collections are replaced with new samples and the next image vector is formed. This process repeats through an angular rotation in the array to create new image vectors while sampling their element cross-product contributors around the array. [0100] The method used for the creation of a single “forward looking” sagittal B-mode image plane may be expanded to create multiple rotated sagittal planes around an axis either congruent with the catheter central axis, or itself slightly tilted off the catheter central axis. If enough rotated planes are collected, the beam-forming system could then possess a capability to construct and display arbitrary oblique “slices” through this multidimensional volume, with B-mode or C-mode visualization in either a 2-D sector format, a 2-D circular format, or, other multidimensional formats. The echo data volume may also be off-loaded to a conventional 3-D graphics engine that could create the desired image format and feature rendering that would enable improved visualization. In the same manner as described in the processing of the “forward looking” C-mode image, the vector echo data is processed through envelope detection of the echo data and rejection of the RF carrier. Finally a process of coordinate conversion is done to map the radial vector lines of echo data to a video sector-format display of the “forward looking” B-mode image. [0101] This processing system, through the host control, may also accomplish “forward looking” target (such as blood cells) velocity detection by either correlation-tracking the targets along the “forward looking” direction (with processing as earlier discussed with the “side looking” approach), or by standard Doppler processing of echo frequency shifts that correspond to target movement in directions parallel with the “forward looking” echo paths in the “forward looking” B-mode plane. The target (e.g. blood) velocity information may be displayed as a color on the video display; this velocity color information is superimposed on the image display to allow the user to see simultaneous anatomical information and target movement information. [0102] The disclosure has a number of important features and advantages. It provides an ultrasonic imaging transducer and method that can be used for imaging tissue in multiple planes without any moving parts. It can operate in both forward and side imaging modes, and it permits imaging to be done while procedures are being carried out. Thus, for example, it can operate in a forward looking C-mode, while at the same time a therapeutic device such as a laser fiber-bundle can be used to treat tissue (e.g. an uncrossable arterial occlusion) ahead of the catheter tip either by tissue ablation, or, tissue photochemotherapy. The laser pulses may be timed with the ultrasound transmit-receive process so that the high frequency laser induced tissue reverberations can be seen in the ultrasound image plane simultaneously. In this way the disclosure can dynamically guide the operator's vision during a microsurgical procedure. [0103] In some instances, the present disclosure is directed to a method of crossing a severe occlusion of a vessel of a patient. In that regard, the method includes introducing a flexible, elongate imaging device into the vessel of the patient, advancing the imaging device to a position immediately adjacent the severe occlusion of the vessel such that a tapered distal tip of the imaging device is in contact with the occlusion and such that at least one imaging element of the imaging device is spaced from the occlusion by a distance less than 5 mm, less than 3 mm, or less than 1 mm; and obtaining images of the vessel, including the occlusion, with the imaging device positioned immediately adjacent the severe occlusion. In some instances, the imaging device is an ultrasound device and the at least one imaging element is an ultrasound transducer. In other instances, the imaging device is an optical coherence tomography device and the at least one imaging element is an optical fiber or a reflector. Further, in some embodiments flexible, elongate imaging device is a catheter, such as a rapid-exchange catheter or an over-the-wire catheter. The method also includes penetrating the severe occlusion based on the images obtained by the imaging device. In that regard, penetrating the severe occlusion includes advancing an occlusion crossing device through a central lumen of the catheter to the occlusion. The occlusion crossing device may be one or more of an ablation device and a puncture device. In some instances, penetrating the severe occlusion comprises partially crossing the severe occlusion such that a recess is created in the occlusion, and the method further includes advancing the imaging device into the recess created by the partial crossing; obtaining images of the vessel, including the partially crossed occlusion, with the imaging device positioned within the recess; and further penetrating the severe occlusion based on the images obtained by the imaging device while positioned within the recess. This process can be repeated until the occlusion has been completely crossed. Further, in some instances, after the occlusion has been crossed a balloon or other expansion mechanism may be introduced into the opening created through the occlusion and used to further expand the opening. In some instances, the balloon or other expansion mechanism is attached to or formed as part of the imaging device. [0104] In some embodiments, an imaging device for use in imaging a severe occlusion of a vessel of a patient is provided. The device includes an flexible elongate body having proximal portion and a distal portion, the flexible elongate body having a constant diameter along a majority of its length between the proximal and distal portions, the distal portion defining a distal tip that tapers from the constant diameter of the flexible elongate body to a smaller diameter as the distal tip extends distally along a longitudinal axis of the flexible elongate body, wherein the tapered portion of the distal tip has a length less than 5 mm as measured along the longitudinal axis of the flexible elongate body, and wherein at least the distal portion of the flexible elongate body includes a lumen extending along its length; and at least one imaging element secured to the distal portion of the flexible elongate body proximal of the tapered portion of the distal tip such that the at least one imaging element is spaced from a distal end of the flexible elongate body by a distance of 5 mm or less. In some embodiments, the imaging device is an ultrasound device and the at least one imaging element is an ultrasound transducer, such as single ultrasound transducer or an array of ultrasound transducer elements. In other embodiments, the imaging device is an optical coherence tomography device and the at least one imaging element is an optical fiber or a reflector. In some instances, the lumen is in communication with an opening in a sidewall of the flexible elongate body such that the imaging device is configured as a rapid-exchange catheter. In some instances, the lumen extends along a full length of the flexible elongate body such that the imaging device is configured as an over-the-wire catheter. [0105] Aspects of the present disclosure can also be used in a biopsy or atherectomy procedure to allow the operator to perform a tissue identification prior to tissue excision; the advantage being that the catheter or biopsy probe device can be pointing in the general direction of the target tissue and thus aid significantly in the stereotaxic orientation necessary to excise the proper tissue sample. The disclosure can also be used for the proper positioning of a radiotherapy core wire in the treatment of target tissue that exists well beyond the distal extent of the catheter. [0106] Persons skilled in the art will recognize that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.

1a

The invention concerns a platform assembly mobile within a cylindrical structure. A platform assembly of this kind is designed to receive passengers and is intended to be installed in theme parks and tourist sites, for example. DESCRIPTION OF THE PRIOR ART Various systems are known for enabling passengers to be lifted up and obtain the benefit of an unrestricted view of a landscape of interest or simply for their amusement. For example, U.S. Pat. No. 7,926,787 describes a platform assembly designed to receive passengers and a mechanism for raising the platform assembly by means of inflatable pockets enabling the platform assembly to be raised and lowered. Other systems are known in which the platform assembly intended to receive the passengers is suspended. These systems are more impressive for the passengers because they have the sensation that there is nothing under their feet. For example, a platform assembly suspended by a cable from the boom of a crane is used to receive guests and to organize a dinner or an event high up and combining dining and amusement (see www.dinnerinthesky.com). Published patent FR 2882996 in the name of the applicant describes a system with a basket suspended from a balloon that is its mobile within a tower, the basket being able to receive passengers. The cited suspended systems suffer from the problem of balancing the platform assembly or the basket once the passengers have boarded, however, and the drawback of having elements above the passengers. In an even more classic way, lifts enable passengers to be carried in a cabin. The cabin is either suspended from a central fixed point or pushed by a system situated at the bottom, for example a ram, thus reducing the sensation experienced by the passengers. For obvious safety reasons, the proximity of the supporting structure guiding the cabin moreover obliges the passengers to be safely inside a closed cabin which may at best be glazed. Finally, other elevating platform assembly systems consist of a fixed pylon (tower) and a lateral or annular basket surrounding the pylon and able to move in translation along the pylon. In these cases, the bulk of the tower and its proximity to the basket rule out a 360° view. The height to which such a platform assembly can be raised is moreover limited by stability constraints. U.S. Pat. No. 1,034,864 describes a device consisting of a tower comprising uprights, reinforcements and platforms. A spiral track is mounted between the uprights. A vertical shaft comprising channels is mounted at the centre of the tower. A structure comprising passenger-carrying cars is mounted around the vertical shaft, said structure being connected to the channels and disposed on wheels on the spiral track. The present invention provides an ascending platform assembly intended to receive passengers that enables a very high level of stability at the same time as offering the passengers a strong sensation of being lifted up in the open air, with minimum obstruction of a panoramic view. SUMMARY OF THE INVENTION In a first aspect, the invention concerns an assembly comprising a platform assembly intended to receive passengers, a cylindrical structure, the platform assembly being mobile within the cylindrical structure. In a preferred embodiment, the cylindrical structure comprises at least three vertical posts. The three posts may be connected by braces. The cylindrical structure has a circular base, for example, with braces curved in a helix, or more simply cylindrical with a triangular base. Further, the assembly includes at least three carriages fastened to the platform assembly and adapted to be attached to drive cables accommodated in guide rails of at least three of the posts of the cylindrical structure. With nothing above or below them, the passengers in the attraction experience strong sensations and have the benefit of an unrestricted view. The stability of such a structure enables lifting to several tens of meters, or even around 100 meters. It is therefore possible to organize events of the dinner-in-the-sky, cocktail party, etc. type. In one variant, the assembly comprises, for each carriage, a fall-preventing mechanism. For example, the fall-preventing mechanism comprises a finger fastened to the carriage and a rack fixed to the guide rail, the finger being designed to abut against a tooth of the rack in the event of loss of tension in the cable. In one variant, the platform assembly comprises a central platform and beams extending from the central platform, the carriages being fixed to the ends of the beams. In one variant, the assembly includes a motor associated with each drive cable to drive the cable in one direction or the other. In one variant, the assembly comprises a control unit adapted to synchronize the cable drive motors. In one variant, the assembly comprises a cover for protecting passengers against inclement weather fixed above the platform assembly. The cover is inflatable and of ellipsoidal shape, for example. BRIEF DESCRIPTION OF THE FIGURES Other aspects and advantages of the invention will become apparent on reading the following description, illustrated by the following figures: FIGS. 1A and 1B are diagrams showing a platform assembly in accordance with one embodiment of the invention that is mobile within a cylindrical structure; FIG. 2 is a perspective view of one particular embodiment of the assembly formed of the cylindrical structure and the mobile platform assembly; FIG. 3 is a detail view of the drive system of the mobile platform assembly from FIG. 2 ; FIG. 4 is a perspective view of a platform assembly in one embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION FIGS. 1A and 1B show an assembly in accordance with one embodiment of the invention formed of a platform assembly 100 and a cylindrical structure or tower 200 , respectively with the platform assembly on the ground and with the platform assembly raised. FIG. 2 shows in more detail one embodiment of the assembly shown in FIGS. 1A and 1B . The tower 200 comprises a vertical structure with at least three posts 250 two of which can be seen in FIGS. 1A and 1B . The tower may also comprise walls between the vertical posts or braces connecting the vertical posts to stiffen the structure, for example braces 260 forming crossmembers or crossed helices, as shown in FIG. 2 . The posts and the braces are metal tubes or structural sections, for example. In accordance with the present invention, the platform assembly 100 intended to receive passengers is mobile within the tower 200 . For example, it is driven up the tower by cables 220 of a drive system. In the example of FIGS. 1A , 1 B and 2 , the tower is substantially cylindrical with a circular base and the circular platform assembly is provided with arms or beams enabling it to be spaced from the tower. This shape is not limiting on the invention, however, and the cylindrical structure forming the tower can have any section, for example hexagonal, triangular or square. As shown in FIG. 2 , the platform assembly 100 may comprise seats 150 for passengers. For example, the seats are arranged around a central platform 110 of the platform assembly, itself connected to the drive system by beams or arms 120 . The seats may face toward the inside or the outside of the tower. In the former case, the passengers have the benefit or a more friendly arrangement; in the latter case, they have a direct view over the panorama. The seats may also pivot on themselves so that the passengers have the benefit of a 360° view. The platform assembly may also comprise a cover or roof 400 enabling protection of the passengers from inclement weather. The platform assembly being connected directly to the drive system rather than suspended, stability is significantly improved and a large number of passengers may be arranged around the central platform, even in an irregular manner. For example, the passengers are arranged within a circle that must have a diameter sufficient to accommodate all the passengers comfortably. The tower may have a height between 30 m and 80 m in order to afford a good panoramic view when passengers are raised up on the platform assembly. Moreover, the platform assembly being connected directly to the drive system, it is possible for the passengers to have a completely unrestricted view in the raised position of the platform assembly ( FIG. 1B ), including of the structure itself. For example, the posts 250 comprise guide rails in which the drive cables 220 are placed, for example cables of the type used for lifts. The guide rails are adapted to accommodate respective carriages 300 fastened to the ends of the beams 120 of the platform assembly. Each cable may extend from a winch 160 at the base of the tower to an idler pulley 210 at the top of the tower with a return run from the pulley 210 to the winch 160 . The winch may be of the type used for lift installations; it may be associated with a control unit for controlling the direction of rotation of the cable 220 and regulate its speed; the control unit also synchronizes the movement of the three carriages so that the platform assembly rises in the tower level, i.e. keeping the central platform 110 horizontal. FIG. 3 shows a detail view of the platform assembly driving system in one embodiment. FIG. 3 shows a portion of a post 250 of the tower and a portion of a beam 120 connected to the central platform of the platform assembly. FIG. 3 also shows a carriage 300 accommodated in guide rails of the post 250 and attached to a drive cable 220 . The cable 220 has two cable runs on either side of the idler pulley 210 ( FIGS. 1A , 1 B), a first cable run to which the carriage is attached defining a driving path and a second cable run defining a return path toward the winch 160 for winding in the cable. Each winch may be associated with a motor for driving movement of the cable in one direction or the other. For example, there may be three motors synchronized by an electronic unit to control the movement of the three cables to drive three carriages of the balloon along three posts of the tower. There may of course be more than three carriages and more than three motors if the tower has more than three vertical posts. There may equally well be a single motor driving movement of three cables. FIG. 3 also shows a view in lateral section of a carriage 300 of substantially parallelepiped shape appropriate to a C-section ( 240 ) inside which it slides. The C-section is attached to a post 250 of the cylindrical supporting structure. The carriage is pulled by the cable 220 . Lateral rollers 350 , of which there are four, for example, bear on the right-hand and left-hand sides of the C-section. Transverse rollers 360 bear on the back of the C-section or on these returns. The arms or beams 120 of the platform assembly rest on the shoe of the carriage via a flexible damping member 370 of the Silentbloc® type that provides a flexible interface. A sling 320 suspends the arm from the carriage. Its length is adjustable to adjust the distribution of forces between the sling (tension) and the Silentbloc® (compression) and to optimize the behaviour of the platform assembly. Greater tension in the slings will be reflected in a greater freedom of movement of the platform assembly. Greater compression of the Silentbloc® will be reflected in more severe recentring of the platform assembly. In order to increase the safety of the passengers, the use of a plurality of synchronized motors to drive the movement of a plurality of cables driving the carriages provides redundancy in the event of a breakdown or of a cable breaking. If a cable breaks, the carriage attached to that cable will slide along the post under its own weight, which will cause the platform assembly to tilt toward the post with the broken cable. This tilting, even if not dangerous to safety, may nevertheless frighten the passengers. A fall-preventing mechanism may therefore be provided on each carriage 300 . In normal operation, the cable 220 takes the weight of the carriage and the platform assembly. The tension in the cable 220 drives vertical movement in translation of the link 380 . The spring 381 is stretched and the finger 310 is retracted inside the carriage. If the cable 220 breaks, the tension in the cable disappears and the link is free to move in downward translation, being pulled by the spring 381 and causing the finger 310 to swing toward the exterior of the carriage. The carriage then falls freely until the projecting finger 310 strikes against a tooth of the rack 230 fixed to the back at the centre of the C-section. The spring 382 enables damping of the impact when the link strikes the rack and therefore stopping of the carriage and the platform assembly. FIG. 4 shows one embodiment of a platform assembly comprising a central platform 110 connected to the cylindrical structure by beams 120 . For example, the central platform is equipped with seats 150 for the passengers arranged around a structure forming a bar. The bar and the passengers are protected by a cover 400 . The cover may be of any kind and may include an advertising sign, for example. It could be inflatable, for example. This inflatable cover could advantageously have an ellipsoidal shape, as shown in FIG. 4 , in order to offer minimum wind resistance when the platform assembly is in the raised position and the cover extends beyond the upper edge of the tower. Although described by way of a certain number of detailed embodiments, the assembly formed of the mobile platform assembly and the cylindrical structure in which the platform assembly is designed to be raised lends itself to different variants, modifications and improvements that will be obvious to the person skilled in the art, it being understood that these different variants, modifications and improvements fall within the scope of the invention as defined by the following claims.

1a

This is a continuation of application Ser. No. 08/754,684, filed Nov. 21, 1996 now abandoned. BACKGROUND OF THE INVENTION The field of the present invention is hypodermic syringes. The invention has particular application to those hypodermic syringes which are used for administering medicaments such as vaccines, local anesthetics and antibiotics which are designed to be injected intramuscularly, subcutaneously, or intradermally but not directly into a vein or artery. The invention also has particular application to those hypodermic syringes which are used in introducing catheters and tubes into the lumens of blood vessels. The present invention is directed to certain improvements in the construction of a hypodermic syringe which facilitate one-handed performance of an aspiration test, hereinafter further described, which is useful to avoid the accidental injection of medicaments into blood vessels or else to confirm that the tip of the needle is in the lumen of a blood vessel when this is the desired goal, as in catheterizing a blood vessel. The improvements are ones which are suitable for incorporation into a fully disposable, single-use syringe of compact size and configuration which has barrel and plunger components that can be made of moldable plastics. Correct technique for injecting medicaments which are intended for hypodermic but not intravenous injection requires the practitioner to insert the syringe needle into muscle, subcutaneous or intradermal tissue and then draw back on the plunger and observe whether blood is or is not aspirated into the syringe barrel. If the practitioner observes blood being aspirated, the practitioner takes this as an indication that the needle has perforated a vein or artery, and the needle is then withdrawn and the injection procedure started over at a different site. Performance of this so-called aspiration test is recommended in numerous guides and treatises which physicians and other clinical professionals regularly consult. For example, a well-known nursing training text includes this instruction: "Aspirate by holding the barrel of the syringe steady with your nondominant hand and by pulling back on the plunger with your dominant hand. If blood appears in the syringe, withdraw the needle, discard the syringe, and prepare a new injection. Rationale: This step determines whether the needle is in a blood vessel." (B. Kozier & G. Erb, Fundamentals of Nursing Concepts and Procedures 3d Ed., Addison-Wesley 1987!, p. 1521.) Another well-known nursing treatise, in instructing on how to administer a subcutaneous injection, recommends the aspiration step "to determine whether the needle is in a blood vessel" and warns that " d!iscomfort and possibly a serious reaction may occur if a drug intended for subcutaneous use is injected into a vein." (L. Wolf, M. H. Weitzel & E. Fuerst, Fundamentals of Nursing 6th Ed., J. B. Lippincott 1979!, p. 614). Similarly, a Physicians' Desk Reference (hereinafter cited simply as "PDR") article on Haemophilus b Conjugate (Tetanus Toxoid Conjugate) reconstituted with CLI DTP (Diphtheria, Tetanus and Pertussis) vaccine warns that the vaccine is not to be injected intravenously and recommends: "After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel." (R. Arky, medical consultant, Physicians' Desk Reference 49th Ed., Medical Economics Data Prod. Co. 1995!, p. 903.) In addition to the cited references, there are numerous others which recommend that the aspiration test be performed to minimize risk of unintentionally injecting medicaments into blood vessels. It is noted in the medical literature that failure to perform the aspiration test, resulting in the accidental injection into a blood vessel of a medicament not intended for that mode of administration, may have serious consequences for the patient. For example, in L. Tessio, L. Bassi and L. Strada, Spinal Cord Lesion After Penicillin Gluteal Injection, 6 Paraplegia 442 (June 1992), the authors state that in eight cases seen by or reported to them, gluteal injection of penicillin caused sudden and irreversible paraplegia. The authors suggest that "the mechanism might be the accidental injection into the superior gluteal artery, causing its distal spasm and the upstream ascent of the penicillin with ensuing embolic and/or spastic occlusion of the anterior spinal artery." For another example, it is noted in J. R. Roberts & J. R. Hedges, Clinical Procedures in Emergency Medicine Saunders 1985!, p. 436, that there is risk of inducing convulsions and generalized seizures in patients by injecting local anesthetics (intended for intramuscular or subcutaneous administration) into an artery by mistake. As for vaccines, there is apparently little or no published evidence of toxicity to the patient resulting from accidental injection into a blood vessel. However, for absorption reasons, vaccines are typically designed to be injected intramuscularly or subcutaneously, and immunogenicity from vaccines can depend on proper administration. Hence, there is at least reason for concern that a vaccine intended for intramuscular or subcutaneous injection might not have the same efficacy if injected into a vein or artery, even if no toxicity to the patient would thereby result. (In addition to the PDR article cited above regarding the Haemophilus b Conjugate (Tetanus Toxoid Conjugate) reconstituted with CLI DTP (Diphtheria, Tetanus and Pertussis) vaccine, PDR articles pertaining to other vaccines as well caution that they are not to be injected intravenously. See, e.g., articles on the Measles, Mumps and Rubella Virus Vaccine, PDR, p. 1575, and on the Hepatitis B Vaccine, id., p. 2372).) Although reports of adverse effects on patients from accidental injections of medicaments into blood vessels are apparently not common, the severity of possible risks dictates that the aspiration test should be performed routinely, whenever an intramuscular, subcutaneous or intradermal injection of a medicament is administered. In most clinical settings involving normal adult patients, the drawing-back-the-plunger maneuver, and hence the aspiration test, can be accomplished without any intolerable amount of difficulty because the patient can ordinarily be relied upon to hold still voluntarily. The practitioner thus has both hands free, and so can grasp the barrel of the syringe in one hand while drawing back the plunger with the other hand to check for aspiration of blood. Even with normal adults, however, there are clinical situations (such as, for example, the injection of a local anesthetic into a painful area) in which the need to use one hand to immobilize the injection site, leaving the practitioner with only one hand free to operate the syringe, poses serious inconvenience to a practitioner trying to perform the aspiration test. Where the patient is a child, performance of the drawing-back-the-plunger maneuver is especially likely to prove cumbersome and inconvenient with a conventional syringe. Children, in contrast to normal adults, often struggle when receiving injections, and cannot be depended upon to possess the self-control necessary to hold still voluntarily. Hence, a practitioner who is, for example, injecting a medicament into the arm of a child must take steps to see that the child's arm is held immobile during the injection. Otherwise there is risk of such mishaps as the practitioner's suffering an accidental needle stick, or breaking off the needle in the patient's arm, or accidentally withdrawing the entire needle, or lacerating the patient's tissue. Unless the practitioner has an assistant to hold the child, the practitioner must typically hold the child's arm immobile with one hand while operating the syringe with the other hand. The practitioner therefore does not have two hands free to accomplish the drawing-back-the plunger maneuver; and with a syringe of the kind now conventionally used for the intramuscular, subcutaneous or intradermal injection of vaccines, antibiotics and other medicaments, the maneuver is very difficult, if not altogether impossible, to perform with one hand. The result is that the practitioner is tempted to, and all too often does, forego the drawing-back-the-plunger maneuver, omit the aspiration test, and hence fail to make certain that a vein or artery has not been perforated by accident. Correct technique, and its attendant advantages in terms of safety and efficacy, are thereby sacrificed for convenience's sake. There are clinical situations where the practitioner, rather than desiring to avoid perforating a blood vessel, desires instead to confirm that such perforation has been accomplished. One example of such a situation is when the practitioner desires to accomplish a venous catheterization, that is, the introduction of a catheter, or tube, into the lumen of a vein. Such catheterization may be desired, for example, in order to secure intravenous access for delivery of medicaments or in order to guide a sensing device. to the patient's heart to take cardiac measurements. Typically, catheterization is accomplished by first inserting a relatively large-bore hypodermic needle through a vein, often without a syringe attached. When the practitioner believes that the needle has achieved the through-the-vein position, a syringe containing saline is attached and, while the practitioner withdraws the plunger in an aspirating maneuver, he or she simultaneously begins a gradual withdrawal of the syringe and needle. The practitioner looks for aspirated blood to appear in the syringe, indicating that the tip of the needle has now been withdrawn to the point where it is in the lumen of the vein. With the needle so positioned, the practitioner detaches the syringe and introduces a guidewire into the vein through the bore of the needle. The needle is then slipped out over the guidewire and a catheter is slipped in over the guidewire. Once the catheter is in place the guidewire is withdrawn through the catheter. A syringe is then attached to the catheter and an aspiration stroke is typically performed, the appearance of aspirated blood in the syringe being a reconfirmation that the catheter is correctly positioned in the lumen of the vein. The syringe typically is then used to flush the catheter with heparin to inhibit formation of clots and emboli. The venous catheterization technique just described depends, of course, on the practitioner's success in positioning the tip of the needle within the lumen of the vein; and the aspiration-while-gradually-withdrawing-the-needle maneuver is important in that it confirms that that positioning has been achieved. Syringes according to the present invention, because they render it ergonomically easier than conventional syringes to accomplish the aspiration stroke while handling the syringe with a single hand, enhance the ease and convenience with which the practitioner can accomplish the aspiration-while-gradually-withdrawing-the-needle maneuver. So-called "control syringes" are known in the art which include a pair of finger rings affixed to opposite sides of the barrel (the barrel rings), together with a thumb ring atop the plunger. By inserting the index and middle fingers through the barrel rings and the thumb through the thumb ring, the practitioner can achieve a measure of control over the syringe and can operate the plunger on the backward (withdrawing) stroke with one hand. However, the three-rings arrangement of the "control syringe" is typically seen in a syringe much larger than syringes designed for the intramuscular injection of medicaments and syringes designed for use in venous catheterization procedures. "Control syringes" are typically not intended for those uses, but instead for irrigation and the like. It would not be immediately apparent or obvious to adapt the three-rings feature of the "control syringe" to provide a one-hand-operable syringe for the intramuscular injection of medicaments, because the resulting syringe would have substantial obvious disadvantages. First, the barrel rings, being relatively large and bulky, would increase material cost, would increase the complexity of molding the syringe body if it were attempted to mold it in a single piece, and would make the syringe less compact to package, ship and store. While making the syringe barrel itself larger might make it easier to attach and configure the rings, the use of an unnecessarily large disposable syringe would make for unnecessary cost and waste of materials, and could also make difficult the accurate measurement of doses as small as some doses, especially pediatric doses, can be (e.g., 0.5 cc or the like). Thus, syringe designers would not consider such a design to be acceptable. Secondly, the manual maneuver required to insert the fingers through the barrel rings would be slow and awkward compared to the simpler maneuver of grasping the barrel of the syringe between the fingers (or between finger and thumb) in the region of the finger-stops of the present invention as hereinafter described. Thirdly, neither the barrel rings nor the thumb ring on a conventional "control syringe" are adjustable, but are instead made in fixed diameters designed to admit the largest fingers and thumbs expected to be encountered. Practitioners with average or smaller than average sized fingers will find their grasp of a control syringe to be less than optimally secure because of the looseness, or play, which results from the excessive size of the rings. Fourthly, the non-adjustable ring atop the plunger of a control syringe, necessarily being designed to accommodate the largest normal thumb, will be much too large to make a snug fit with a small or even a normal index finger inserted therethrough; whereas the adjustable plunger loop of the present invention, as hereinafter described, affords equal convenience to those practitioners who choose to operate the plunger with the index finger while grasping the barrel between the thumb and middle finger (as is typical in administering vaccines) and those practitioners who prefer to operate the plunger with the thumb while grasping the syringe barrel between the index and middle fingers (as is typical in administering local anesthetics). SUMMARY OF THE INVENTION The present invention provides an improved hypodermic syringe for the intramuscular, subcutaneous or intradermal injection of vaccines, antibiotics, anesthetics and other medicaments, and for the catheterization of blood vessels. The improvements are designed to encourage the practitioner, when inserting medicaments not intended for intravenous delivery, to perform the aspiration test by making it easy and convenient to operate the syringe on the backward (plunger-withdrawing) stroke with a single hand, thereby to observe whether or not blood is aspirated into the syringe, indicating that a blood vessel has been perforated and that the needle should be withdrawn and the injection procedure started over. The improvements also make the syringe of the present invention more easily usable in procedures involving the catheterization of blood vessels. The improvements, because they facilitate one-handed performance of the aspiration test, make the syringe especially desirable for injecting pediatric patients, for injecting patients in areas where it is cumbersome to have two hands on the syringe, and in general for injecting patients who, because of tremors, convulsive disorders or other reasons, cannot or will not hold still for an injection and require the practitioner to use one hand to stabilize the injection site while using the other hand, alone, to operate the syringe. The hypodermic syringe of the present invention is preferably of the fully disposable type, having a barrel molded from plastic in a single piece and a plunger member also molded from plastic in a single piece, fitted at the distal end thereof with a conventional piston that cooperates with the bore of the barrel in the conventional way. The barrel is provided at the distal end with a conventional hub on which is mounted (preferably detachably) a conventional hollow needle. The plunger member is fitted at the proximal end with a loop that can be adjusted to embrace, snugly but easily releasably, a variety of sizes of fingers and thumbs when inserted therethrough. At diametrically opposed positions upon the exterior surface of the barrel, and preferably molded integrally therewith, is a pair of finger-stop structures which serve as barriers such that when the barrel is grasped in the region of the finger-stop structures between the index and middle fingers (or between the middle finger and thumb, if the index finger is being used to operate the plunger), the fingers grasping the barrel are not only prevented from slipping in the proximal (rearward) direction along the barrel during the forward (injection) stroke of the plunger but are also prevented from slipping in the distal (forward) direction along the barrel during the backward (aspiration) stroke of the plunger. The finger-stop structures are preferably not fully circumferential about the barrel, and preferably are so positioned as not to interfere with the legibility of a calibration scale which is inscribed longitudinally upon the barrel and which extends into, or through, that region of the barrel with which the finger-stop structures are associated. Thus it is an object of the present invention to provide a hypodermic syringe that is ergonomically well adapted to the structural and functional limitations of the human hand, such that the syringe is easily operable, both on the backward (aspiration) and forward (injection) stroke, with but a single hand. It is a further object of the present invention to provide an improved hypodermic syringe that promotes safe and sound injection technique by facilitating performance of the aspiration test in patients, such as pediatric patients and persons with tremors and convulsive disorders, who typically will not, or cannot, voluntarily hold still while being injected. It is a further object of the present invention to promote the safe, rapid and efficient administration of intramuscularly, subcutaneously or intradermally injected medicaments to large numbers of patients, especially children, by enabling a single practitioner properly to inject them without the help of an assistant to hold the patients. It is a further object of the present invention to provide a disposable hypodermic syringe for the intramuscular, subcutaneous or intradermal injection of medicaments whose body and plunger member are each moldable in a single piece. Yet a further object of the present invention is to provide a disposable hypodermic syringe which is convenient for one-handed use in injecting local anesthetics. Still another object of the present invention is to provide a disposable hypodermic syringe for the intramuscular, subcutaneous or intradermal injection of medicaments which is compact in its dimensions, thereby to conserve space in its packaging, shipping and storage and to conserve materials in its manufacture. An additional object of the present invention is to provide a syringe which promotes ease and efficiency in accomplishing venous catheterization, in that it facilitates performance of the above-described aspiration-while-gradually-withdrawing-the-needle maneuver, and the above-described aspirating-blood-through-the-catheter maneuver, with a single hand. Other purposes, advantages and objects of the present invention will appear from the description that follows, including the drawings which are parts hereof. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a hypodermic syringe illustrating a preferred embodiment of the invention. FIG. 2 is a view along the longitudinal axis of the syringe body, from the distal end. It illustrates the diametrically opposed positions of two finger-stop structures on the exterior surface of the syringe barrel. FIG. 3 is a plan view of the plunger member of a hypodermic syringe according to the present invention, having at its distal end a conventional piston and at its proximal end on alternative embodiment of a plunger button with two loop members formed integrally therewith which, when closed together, define the aperture of an adjustable plunger loop. FIG. 4 is a detailed plan view of the proximal end of the plunger assembly, showing the adjustable plunger loop of FIG. 3 with its aperture closed about a finger (or thumb) which has been inserted therethrough and secured therein. FIG. 5 is a detailed plan view of another alternative embodiment of an adjustable plunger loop having two loop members which define an aperture through which a finger (or thumb) can be inserted to be held securely therein. FIG. 6 is a detailed plan view of another alternative embodiment of an adjustable plunger loop, having a single loop member which defines an aperture through which a finger (or thumb) can be inserted to be held securely therein. FIG. 7 is a detailed plan view of another alternative embodiment of an adjustable plunger loop, having a single loop member which defines an aperture through which a finger (or thumb) can be inserted to be held securely therein, the size of said aperture being adjusted by drawing the free end of the loop member through a ratchet housing. FIG. 8 is a cross-sectional view, taken though the ratchet housing of FIG. 7, which illustrates the cooperation between the teeth on the outer surface of the free end of the loop which passes through the ratchet housing and the teeth on a pawl which is movably mounted within the ratchet housing. FIG. 9 is a perspective view of a portion of the barrel of a syringe made according to the present invention, showing a pair of finger-stop structures at diametrically opposed positions on the external surface of the barrel, and a calibration scale affixed longitudinally upon the barrel and extending into the longitudinal region of the barrel where the finger-stop structures are located, but at a radially different position such that the finger-loop structures do not interfere with the legibility of the calibration scale. FIG. 10 is a perspective view showing the syringe barrel being grasped between the index and middle fingers of a hand while the thumb is poised to operate the plunger, as is typical when the syringe is being used to inject a local anesthetic. FIG. 11 is a perspective view showing the syringe barrel being grasped between the thumb and the middle finger of a hand while the index finger is poised to operate the plunger, as is typical when the syringe is being used to inject a vaccine. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The syringe of the present invention, a preferred embodiment of which is illustrated in FIG. 1, includes a body 10 having a barrel portion 1 which outwardly is generally configured as a right circular cylinder for most of its length and has a frusto-conical portion 2 near the distal end, where the body diameter reduces down to the diameter of a conventional hub 3, upon which is mounted (preferably detachably) a conventional hollow needle 4. The body 10 includes a hollow bore (shown in phantom) which is open at the proximal end to receive a plunger member 20. The bore within the barrel portion of the syringe body is generally configured, according to convention, as a right circular cylinder so dimensioned that the plunger shaft 23, with the piston 21 at its distal end, fits closely but slidably therein. The syringe body 10 is preferably made of moldable plastic in a single piece, but any of a number of other materials would also be suitable, including for example glass or metal, and the body could be made in multiple pieces which could then be fused, cemented or otherwise joined together by conventional means. On the barrel portion 1 of the syringe body 10, at diametrically opposed positions, is a pair of finger-stop structures 5, 5. In the preferred embodiment shown in FIGS. 1 and 9, each of the finger-stop structures has a distal barrier 6 and a proximal barrier 7 which define a region 8 therebetween, which region 8 is sufficiently wide and deep to accommodate an adult finger or thumb, so that the syringe barrel can easily be grasped in region 8 between the index and middle fingers (if the practitioner chooses to operate the plunger with the thumb as shown in FIG. 10) or between the middle finger and thumb (if the practitioner chooses to operate the plunger with the index finger as shown in FIG. 11). When the syringe barrel is grasped in region 8 between said fingers (or between said finger and thumb), slippage of the fingers down the barrel in a distal direction is blocked by the distal barrier 6, while slippage up the barrel in a proximal direction is blocked by the proximal barrier 7. Thus the finger-stops are dual-directional: They impede slippage of the barrel-grasping fingers in both the distal and the proximal direction. In this they differ from the flange often seen at the proximal end of a conventional molded syringe barrel, which flange is designed to block slippage of the fingers in the proximal direction only. The finger-stop structures 5, 5 need not be positioned at the extreme proximal end of the syringe body 1, but may be positioned longitudinally at some intermediate place between the proximal and distal ends of the barrel portion 1 of the syringe body 10. The finger-stop structures preferably are molded integrally with the rest of the syringe body 10, as this avoids the extra manufacturing steps of separately making the finger-stop structures and of affixing them to the barrel; but they can be made separately and affixed by conventional means such as bonding by heat or any suitable glue or cement. As is most clearly seen in FIGS. 1, 2, 9 and 11, the finger-stop structures 5, 5 do not occupy the entire circumference of the barrel in the longitudinal region thereof at which they are placed. Instead they leave part of that circumference unobstructed, so that a calibration scale 11 can be inscribed longitudinally along the barrel continuously without hindrance or interruption, and without compromise to its legibility where the calibration scale passes into or through the longitudinal region of the barrel at which the finger-stop structures are placed. As is best seen in FIGS. 1 and 9, the calibration scale does enter the longitudinal region where the finger-stop structures are, but the calibration scale occupies a different radial position than do the finger-stop structures, thus avoiding interference. This arrangement affords the practical advantage of avoiding unduly lengthening the barrel, as would be necessary if the entirety of the calibration scale had to be located distally of the finger-stop structures. Unnecessary barrel length is undesirable for several reasons, including these: It compromises the goal of compactness of packaging, storage and shipping of the syringes, a consideration particularly important in disposable syringes, which are typically sold and used in large quantities and as to which the costs associated with packaging, shipping and storage are typically a more important consideration than with syringes designed to be reused; it requires more material to manufacture a longer syringe barrel (and a longer plunger assembly to cooperate with the longer barrel), thus increasing cost and waste; and a longer barrel requires greater length of travel of the plunger during the stroke, making the syringe less easily controllable and the plunger member ergonomically harder to operate in both directions with one hand. It will be appreciated that finger-stop structures much different from those shown in FIGS. 1, 2 and 9 may be used instead. Any pair of structures formed upon, attached to or impressed into diametrically opposed places on the barrel may serve the purpose of dual-directional finger-stops as long as those structures serve to inhibit slippage of the syringe-holding fingers in both the proximal and the distal direction along the barrel. Among the alternative structures that could be employed as finger-stops at diametrically opposed places on the barrel are, for example, the following: Patches of knurled, scored or otherwise roughened surface upon the exterior of the barrel; dimples or depressions or other concavities in the exterior surface of the barrel; or a pair of parallel, interrupted rings occupying a portion of the circumference of the barrel. Even a single such interrupted ring, if located at a suitable longitudinal position intermediate between the proximal and distal ends of the barrel (such as at region 8 indicated in FIGS. 1 and 9), would serve as an adequate dual-directional finger-stop, although some convenience would be sacrificed by the operator's need to perform a grip-shifting maneuver in transitioning from the upward (aspiration) stroke to the downward (injection) stroke; that is, the syringe-grasping fingers would have to be positioned above (i.e., proximally from) the single interrupted ring so that it would serve as a barrier against slippage in the distal direction during the upward (aspiration) stroke but then shifted to a position below ((i.e., distally from) the ring so that it would serve as a barrier against slippage in the proximal direction during the downward (injection) stroke of the plunger. As seen in FIG. 3, the plunger member 20 includes at its distal end a piston 21, preferably made of rubber or other resilient material and preferably having at least one ring 22 which, when the plunger shaft 23 is inserted into the bore, forms a seal with the wall thereof which is impermeable to liquids and gases. At the proximal end of the plunger shaft 23 is a plunger button 24, having associated therewith an inferior loop member 25 and a superior loop member 26. The loop members are preferably made of a flexible plastic material and are preferably integrally molded with plunger button 24, which in turn is preferably integrally molded with plunger shaft 23. Upon the superior surface of inferior loop member 25, and preferably molded integrally therewith, are a series of whisker-like projections 27. It will be appreciated that they do not project perpendicularly from the surface of said inferior loop portion, but at a slightly backward slant with reference to the distal end thereof. A corresponding series of whisker-like projections 28 is formed on the inferior surface of the superior loop member 26. If desired, the inferior loop member 25 may be biased upwardly and the superior loop member 26 biased downwardly, so that in the structure's resting state the superior surface of inferior loop member 25 bears against the inferior surface of superior loop member 26, causing whisker-like projections 27 to engage the whisker-like projections 28. Alternatively, the two loop members may be biased so that they are spaced apart, as seen in FIG. 3, but may be urged together to form a closed aperture which is tightened around, and securely holds, a finger or thumb inserted therethrough, as seen in FIG. 4. It will be appreciated that when the whisker-like projections 27 and 28 are engaged with each other, they cooperate in a ratchet-like manner, such that the loop aperture which loop members 25 and 26 define can be made smaller by sliding the superior loop member 26 distally (leftwardly in FIG. 3), but the structure resists sliding in the opposite direction. Hence, the whisker-like projections cause the superior and inferior loop members to cooperate with each other in such a manner that the loop aperture can easily be made smaller but will resist being made larger when the whisker-like projections 27 and 28 are engaged with each other. As can best be seen in FIG. 4, superior loop member 26 can be closed down upon inferior loop member 25 and, either by pulling superior loop member 26 in its distal (i.e., leftward, in FIG. 4) direction or by pinching together the left and right sides of the loop formed by loop members 25 and 26, a finger or thumb T can be snugly embraced within the loop aperture formed by the cooperation of said loop members. As can readily be seen, the two loop members may be slipped and slid with respect to each other so as to adjust the size of the aperture they form, thereby to accommodate a variety of differently-sized fingers and thumbs, making the loop adjustable to accommodate different practitioners' different finger sizes, and to accommodate each practitioner's personal preference whether to operate the plunger with the index finger or with the thumb. It will also be appreciated that when the finger or thumb T exerts force upwardly in the direction indicated by arrow A1 in FIG. 4, as it would if the finger or thumb T were being used to withdraw the plunger from the syringe barrel, as in performing the aspiration test, the whisker-like projections 27, 28 will be pressed forcibly against each other, causing the loop aperture to resist opening. When the injection procedure is completed, finger or thumb T can be easily released simply by lifting up the distal end of superior loop member 26 in the direction of arrow A2, shown in FIG. 4, thereby disengaging the whisker-like projections 27, 28 from each other and permitting the opening of the loop aperture and the easy release of the thumb or finger held within that aperture. Alternatively, the finger or thumb may simply be withdrawn from the aperture of the loop without opening the loop. Hence, an adjustable and easily releasable plunger loop is provided which serves to facilitate one-handed performance of the aspiration step. As should be apparent from the foregoing description, whisker-like projections 27, 28 function as means for fastening loop members 25 and 26 together in a conveniently adjustable and releasable way. Other means are available which are equivalent to, and may readily be substituted for, whisker-like projections 27, 28 to achieve the adjustable and releasable fastening function thereof. For example, cooperating VELCRO® fastener strips could be applied to the superior surface of loop member 25 and to the inferior surface of loop member 26, in lieu of whisker-like projections. For another example, a strip coated on both sides with a pressure-sensitive adhesive could be applied to the superior surface of loop member 25, or to the inferior surface of loop member 26, or to both surfaces, in lieu of whisker-like projections. Such adhesive strips are readily obtainable in the market. For instance, tape with pressure-sensitive adhesive on both sides, and flat, rectangular patches coated on both sides with pressure-sensitive adhesive, are widely available under brands including the SCOTCH® brand. These and virtually any like material could readily be adapted, by a person skilled in the art, to provide the desired adjustable and releasable fastening means. FIG. 5 shows an alternative embodiment of an adjustable and easily releasable plunger loop. It is preferably made of a resilient, elastomeric plastic and is preferably molded of a single piece with the plunger shaft 23, although it can be made separately and affixed at the proximal end of the shaft 23 by conventional means such as gluing, cementing or heat bonding. If desired, a plunger button 24 (not shown in FIG. 5 but indicated in FIGS. 1 and 3) can be provided in association with the plunger loop. The plunger loop of FIG. 5 comprises an inferior loop member 40 and a superior loop member 41 which are biased to return to their resting state, as shown, and to form a loop which defines an aperture through which a thumb or finger can be inserted. Preferably the diameter of the aperture thus defined is, in the loop members' resting state, small enough to fit snugly a small adult index finger. When the operator's thumb or finger is inserted into the aperture, loop members 40 and 41 are displaced in a manner that expands the aperture to accommodate the thumb or finger; but because the loop members are biased to return to their resting state, they exert springing forces which hold the finger or thumb securely, and the plunger loop they form resists opening and prevents escape of the thumb or finger during performance of the upward (aspiration) stroke of the plunger. When the injection procedure is complete, the thumb or finger is released simply by withdrawing it from the loop. It will be appreciated that whereas the embodiment of the adjustable plunger loop shown in FIGS. 3 and 4 employs whisker-like projections 27, 28 to provide adjustability of the loop and resistance against opening during the aspiration step, the embodiment of FIG. 5 depends principally on the springing forces exerted by loop members 40 and 41 to accomplish these purposes. Another alternative adjustable plunger loop structure is illustrated in FIG. 1, where loop members 30 and 31, preferably formed integrally with plunger button 24, are generally configured as overlapping arcs of a circle when in their resting state. Loop members 30 and 31 are made of a resilient material, biased to return to their resting state after a load is withdrawn. In their resting state, loop members 30 and 31 define an aperture that is preferably no larger than a small adult index finger. When an index finger or thumb that is larger than the aperture is attempted to be inserted therein, loop members 30 and 31 are displaced sufficiently to accommodate the finger or thumb; but because they are biased to return to their resting state, they exert a springing force upon the finger or thumb, embracing it snugly. When the thumb or finger so embraced is then lifted to exert a withdrawing force upon the plunger, loop members 30 and 31 retain it, enabling the accomplishment of the aspiration test. After that test, or the injection procedure, is complete, the thumb or finger may be withdrawn. Loop members 30 and 31 in the embodiment shown in FIG. 1 thus act similarly to loop members 40 and 41 in the embodiment shown in FIG. 5, a difference, however, being that loop members 40, 41 overlap in an "over-and-under" fashion while loop members 30 and 31 overlap in a "side-by-side" fashion. It will be appreciated that a single-arm loop structure could be employed, instead of either the two-overlapping-loop-members structure described above and shown in FIG. 1 or the two-overlapping-loop-members structure described above and shown in FIG. 5. Such a single-arm loop structure is shown in FIG. 6, where single loop member 50 defines an aperture open at one side, rather than aperture closed on all sides. Loop member 50 is preferably molded integrally with, but may be formed separately and affixed at the proximal end of, plunger shaft 23. If desired, a plunger button 24 (not shown in FIG. 6 but indicated in FIGS. 1 and 3) may be provided in association with loop member 50. Loop member 50 is preferably made of a resilient, elastomeric plastic and it preferably forms an aperture which, in the resting configuration shown in FIG. 6, has a diameter not larger than that of a small adult index finger. When the operator's thumb or finger is inserted into the aperture, loop member 50 is displaced to accommodate that thumb or finger; but because loop member 50 is biased to return to its resting configuration, it captures and snugly holds the finger or thumb and resists further opening when the finger or thumb is raised to perform the upward (aspiration) stroke. Loop member 50 is preferably provided, at the free end thereof, with a detent 51 which serves to prevent escape of the thumb or finger from the open side of the aperture when the loop is under load, as when the captured finger or thumb is being used to apply a plunger-withdrawing force. Yet another alternative for constructing an adjustable plunger loop is shown in FIGS. 7 and 8. Single loop member 60 is made of a flexible material, preferably a plastic, and is fixed at one end to the proximal end of plunger shaft 23. It is preferably molded of a single piece with the plunger shaft, although it can be formed separately and attached to the plunger shaft by conventional means. Loop member 60 may, if desired, be provided in association with a plunger button 24 (not shown in FIGS. 7 and 8, but indicated in FIGS. 1 and 3). At least the portion near the free (distal) end of loop member 60 has upon its superior surface, and preferably formed integrally therewith, a series of sawtooth projections 61. Ratchet housing 62 is preferably molded integrally with plunger shaft 23 but may be formed separately and attached by conventional means. When the free end of loop member 60 is conducted through ratchet housing 62, a closed loop is formed through which the operator's thumb or finger may be inserted. Ratchet housing 62 is provided with a pawl 63 which comprises one or more sawtooth projections configured to mesh with those on loop member 60. Preferably, pawl 63 is also provided with a releasing tang 64. Pawl 63 is pivotably mounted within the ratchet housing and is biased to contact loop member 60 so that the sawtooth projections on loop member 60 mesh with one or more sawtooth projections on the pawl. Preferably the mounting of the pawl, and its bias to engage the sawtooth projections on the loop member, are accomplished by making the pawl of a flexible material and forming it integrally with the ratchet housing. It will be appreciated that the cooperation of the loop member 60 with the pawl 63 provides a snare-like action, such that the loop can be easily adjusted to make the aperture smaller and tighten it around a finger or thumb which is inserted therethrough, but the loop resists opening under load. The tightening adjustment is accomplished by pushing or pulling the free end of the loop member 60 farther through the ratchet housing 62. The pivotably mounted pawl rides over the sawtooth projections on the loop member and permits its passage so as to decrease the size of the aperture; but when a withdrawing force is applied, the sawtooth projections on the loop member engage with one or more corresponding projections on the pawl and resist the enlargement of the loop aperture. After the injection procedure (or the use of the syringe in a venous catheter-insertion procedure) has been completed, the operator may simply withdraw the finger or thumb from the aperture. Alternatively, the pawl may be provided with a tang 64 which affords the operator a convenient means to disengage the pawl from the loop member so as to permit the latter's withdrawal from the ratchet housing and the enlargement of the plunger loop so as to facilitate withdrawal of the operator's finger or thumb. It is within the skill of the art to devise a snare-like loop-size adjustment means which is simpler than that shown in FIGS. 7 and 8 but which will still work adequately for the purpose. For example, it is possible to dispense with the pivotably-mounted pawl and use instead a single ratchet tooth, mounted in or formed integrally with the roof (that is, the side facing sawtooth projections 61) of the ratchet housing 62, and to dimension the ratchet housing and tooth so that the tooth engages the sawtooth projections 61 on the loop member 60. By varying the flexibility if the materials, or by varying the pitch of the ratchet tooth and the sawtooth projections 61 or the dimensions thereof, or the degree of interference therebetween, practitioners of skill in the art can readily arrive at a configuration which affords acceptable ease of closing the loop and an acceptable amount of resistance by the loop against opening under load. If both great ease of closing the loop and high resistance to opening are desired, the pitch of the sawtooth projections 61 and the ratchet tooth can be varied so that the pitch of the proximally-facing (i.e., toward the fixed end, and away from the free end, of loop member 60), sides of the sawtooth projections on the loop member 60 is much steeper than the pitch of the distally-facing (i.e., toward the free end of loop member 60) sides thereof. It will be appreciated that if the projections on the loop member are so configured they will cooperate with the ratchet tooth to provide a snare-like loop size adjustment means, in that the loop may easily be tightened by pulling on the distal end of loop member 60 to conduct it through ratchet housing 62, but may not easily be loosened. Thus the finger or thumb T may be secured snugly within the aperture defined by the loop member and may be withdrawn from the aperture thereafter without loosening it; or, by applying sufficient force, the loop member may be made to withdraw partially from the ratchet housing so that the plunger loop loosens to facilitate withdrawal of the finger or thumb. As will be evident from the foregoing description, a practitioner using the syringe here disclosed for the injection of medicaments can easily and conveniently perform the aspiration test with a single hand, by performing the following steps: First the practitioner picks up the syringe by grasping the barrel between thumb and middle finger as shown in FIG. 11 (or, if preferred, between index and middle fingers as shown in FIG. 10) in the region of the finger-stop structures. Next, the practitioner inserts the index finger (if the thumb is being used to grasp the barrel) or the thumb (if the index finger is being used to grasp the barrel) through the loop aperture. Next, the aperture is adjusted if necessary, as described above, to secure the plunger-operating finger (or thumb) snugly within it. The practitioner then loads the medicament into the syringe, measuring its amount with the syringe's calibration scale if desired. Using one hand to stabilize the patient's arm (or other injection site), the practitioner then inserts the needle with the other hand. Because the plunger-operating finger (or thumb) is secured within the adjustable loop aperture atop the syringe's plunger member while the barrel is being securely grasped by other fingers of the same hand through the use of the finger-stops, the practitioner can easily draw the plunger backward to perform the aspiration test simply by raising the plunger-operating finger or thumb. If the test indicates that a blood vessel has been punctured, and intravenous injection of the medicament is not desired, then the practitioner withdraws the needle and starts over; but if a blood vessel has not been punctured, then the practitioner proceeds with the injection in the usual way. A practitioner who desires to insert a catheter or tube into the lumen of a blood vessel can manipulate the syringe here disclosed in a similar manner, so far as the techniques of grasping the syringe barrel and engaging the plunger-operating finger or thumb with the plunger are concerned. The present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The presently disclosed embodiments are therefore to be considered in all respects as being examples only, the scope of the invention being 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

TECHNICAL FIELD This invention relates generally to an apparatus for withdrawing fluid from the human body, and, in particular, it relates to a device that simultaneously withdraws fluid from the human body and mixes with that fluid a liquid additive containing one or more compounds or agents in a pre-selected proportion before discharging the mixture to a collection point. BACKGROUND OF THE INVENTION Clinical studies and tests have shown that thoracic duct drainage is a mode of therapy by which the deleterious effects of the cell-mediated immune response in man could be abrogated by removal of thoracic duct lymphoytes 1 . Thoracic duct drainage is a technique by which the thoracic duct lymph and its contained lymphocytes are diverted from the body to eliminate one or all of the lymph components. The presumed mechanism is depletion of lymphocytes and possibly depletion of certain immune globulins. In order to produce attenuation, experience has demonstrated that drainage must be continuous for periods of one month or longer. Presently the procedure is costly and technically demanding because the lymph must be processed to remove the cells and then re-infused intravenously. Alternatively, the lymph is discarded and replaced by human serum albumin. Cost estimates for a month of treatment are in the order of twenty to fifty thousand dollars. Although donor or cadaver kidney transplantation becomes more expensive with thoracic duct drainage, there is little or no added morbidity or mortality, and improved graft survival rates are generated. If the cost could be reduced and the technique simplified, greatly improved donor and cadaveric transplant results would be assured. In general the flow rates and the quantity of bodily fluid involved is somewhat variable. One investigator 2 reported on the concept of extra-corporeal lymph dialysis and envisioned flow rates ranging from 1.5 to 2.5 liters per day. However, in four patients the flow rate ranged from 4 to 14 liters per day and averaged in excess of six liters per day. Since no means of bypass was available, it was necessary to collect, dialyze, and infuse the total flow from each patient daily. In addition, fluid pressure must be carefully controlled. Animal studies have shown that clamping the thoracic duct cannula 3 would cause the rapid development of alternate channels which would completely divert all flow from the cannulated duct. Attempts to connect the thoracic duct cannula directly to the venous catheter were only successful when duct pressure exceeded the venous pressure. In fact, since duct pressure varies with metabolic rate, intervals exist when venous pressure substantially exceeds duct pressure. Under these conditions blood could enter the venous catheter and clot. It appears, therefore, that a device used to drain fluid from a thoracic duct must be one that does not produce any back-pressure favorable to the development of collateral channels or cause the lymphatic valves 4 to become incompetent. On the other hand, if the suction pressure is too great the thoracic duct could be forced to collapse. Moreover, since lymph flow rates can vary anywhere from three to one thousand milliliters per hour, the apparatus used to drain or pump the fluid from the duct must adjust almost instantly to this range of flow rates. In addition, the apparatus should have several channels or flow paths--one for metering proportionately an anticoagulant such as heparin or preferably trisodium citrate in a saline solution and a second flow path for infusing anti-humoral drugs, for example. The lymph fluid drawn off by the apparatus would be collected, filtered, treated and/or purified and then redirected back into the patient. The removed lymphocytes would be discarded or used for some other purpose. Another method is phoresis or cytophoresis. Another possibility, under investigation, is to install an extra-corporal bed to which the lymphocytes can attach themselves. In addition, a protein A absorbent may be employed to remove the immune complexes in the lymph. Finally, the drainage procedure provides a ready source of antigen for the production of antilymphocyte serum. Thus, prolonged lymphodepletion by way of thoracic duct drainage can provide excellent pre-transplant immunosuppression for donor or cadaver kidney recipients. A simple, reliable, easy to control device reducing the constant attention and diligence of medical and nursing personnel would improve the acceptance of this technique and reduce present costs. SUMMARY OF THE INVENTION In accordance with the present invention an apparatus is provided that simultaneously draws fluid from inside a patient's body and mixes with that fluid a liquid additive producing a fluid mixture of a pre-selected concentration. The apparatus includes unique features to prevent an adverse effect on the patient resulting from withdrawing fluid too quickly or from excess back pressure. Specifically, the apparatus employs a frame to which are attached tubing or piping defining two passageways or flow paths. One flow path is called "the body fluid flow path" since the inlet to that flow path is adapted to be removably joined to a source of fluid within the patient. The second flow path is called the "additive fluid flow path" since the inlet is adapted to be removably joined to the reservoir of an additive fluid such as an anticoagulant, a fluid containing agents such as cytotoxic materials, or other medicaments. Each flow path contains a reciprocating pumping means, an inlet valve and an outlet valve. The fluid discharged from the additive fluid flow path joins the body fluid flow path at a location upstream of the reciprocating pumping means and downstream of the inlet valve in the body fluid flow path. The confluence of the two flow paths is the place where body fluid and additive fluid are mixed together. The outlet of the body fluid flow path is adapted to be joined to a container suitable for collecting the mixture of additive fluid and body fluid. A motor means, mounted on the frame, operates the inlet and outlet valves and the reciprocating pumping means in each of the two flow paths. Specifically, the motor means sequences the operation of the inlet and outlet valves and the stroking of the reciprocating pumping means so as to mix the additive fluid with the body fluid and to discharge the mixture to a suitable container. A fluid pressure sensor means is positioned in the body fluid flow path downstream of the inlet valve and upstream of the associated reciprocating pumping means. The fluid pressure sensor means applies a control signal to the motor means. If the pressure in the body fluid flow path upstream of the associated reciprocating pumping means becomes abnormal, the motor means is shut off. This insures that an adverse reaction is not produced in the patient's body by the operation of the apparatus. Each inlet and outlet valve preferably consists of a section of flexible tubing that is juxtaposed between a stop joined to the frame and a pinching means which is used to press the walls of the flexible tube against the stop to shut off flow therethrough. A cam and follower operated by the same device powering the reciprocating pumping means may be used to sequence the pinching means. The motor means incorporates features which allow the stroke of the reciprocating pumping means to be adjusted and hence the amount of fluid transferred by the reciprocating pumping means. The inherent versatility, simplicity, and integrated relationship of the components forming the apparatus allows medical personnel to easily understand operation of the components and to quickly troubleshoot them should any difficulty be encountered. Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments illustrated therein, from the claims, and from the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram illustrating the major components of the present invention in a first position; FIG. 2 is the same schematic diagram shown in FIG. 1 illustrating the major components of the present invention in a second position; FIG. 3A is an enlarged view of a portion of the apparatus shown in FIGS. 1 and 2 illustrating one embodiment of the fluid pressure sensor means; FIG. 3B is a second embodiment of the fluid pressure sensor means; and FIG. 4 is an enlarged, partial, schematic diagram of a second embodiment of the motor means used to drive the apparatus shown in FIGS. 1 and 2. DETAILED DESCRIPTION While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail several specific embodiments, with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated. Turning to the drawings, FIG. 1 illustrates the major components 8 of the present invention and one embodiment of the apparatus used to actuate the movable components. For purposes of orientation, the major flow paths will be described first followed by a detailed discussion of the specific components included in those flow paths. The major components 8 are carried on a common frame 9. Briefly, these components include: piping or tubing forming two major flow paths 10 and 18; pumping means 34 and 36; valving means 26, 28, 30, and 32; fluid pressure sensor means 15; and a motor means 48 which is used to operate the valving means and the pumping means. Together they form a closed, sterile flow network. The piping or tubing forming the two flow paths 10 and 18, and the components in fluid communication with the flow paths are fabricated from materials which are easy to clean and sterilize after use. Preferably, the tubing is joined to the frame 9 and the other components in such a manner that it may be easily removed and discarded after use. For convenience and to simplify fabrication, the two flow paths 10 and 18 can be formed from clear plastic tubing. The other components joined to the tubing, such as the pumping means 34 and 36, may be formed from plastic or glass. The first flow path or flow stream 10 is used to conduct fluid from the body of a patient represented by numeral 14, to a collection point or removable collection chamber 11 such as a transfer pack or sterile plastic bag. Because of this relationship, the first flow path 10 will be referred to as the "body fluid flow path." The second flow path or flow stream 18 is used to conduct additive fluid from an external supply tank or reservoir 20 to the body fluid flow path 10 where the additive fluid is mixed with the fluid drawn from the body. Alternatively, the second flow path 18 will be referred to as the "additive fluid flow path." Specifically, one end 12 of the body fluid flow path 10 is adapted to be joined to an interior duct or channel in the body 14 of the patient. The other end 13 of the body fluid flow path 10 is adapted to be joined or removably connected to a collection means or chamber 11. It should be understood that, although the collection means 11 at the outlet of the body fluid flow path 10 is illustrated as a plastic bag (FIG. 1), the outlet may be joined to a filter, or other device used to process the fluid drawn from the patient's body 14. One end 19 of the second flow path 18 is adapted to be removably joined to or connected to an external supply tank or reservoir 20 of additive fluid. The other end 22 of the second flow path 18 is joined to the first flow path 10 at a point 24 intermediate the two ends 12 and 13 of the first flow path 10. This intermediate point 24 forms the "confluence" of the two flow streams 10 and 18. It is here that the additive fluid is mixed with the fluid drawn from the body. Returning to the first flow path 10, valving means are positioned at either end 12 and 13 of the flow path. Specifically, an inlet valve means 26 is located at that end 12 joined to the duct in the body of the patient 14. An outlet valve means 28 is located at the end 13 of the first flow path 10 that discharges the mixture of body fluid and additive fluid to the collection means 11. Similarly, the second flow path 18 has an inlet valve means 30 at that end 19 joined to the reservoir 20 of additive fluid and an outlet valve means 32 at that end 22 joined to the first flow path 10. The operation and sequencing of these valves will be explained at a later point in this discussion. Each flow path 10 and 18 includes a reciprocating pumping means to transfer fluid therethrough. A first reciprocating pumping means 34 is located intermediate the two ends 12, 13 of the first flow path 10. Likewise, a second reciprocating pumping means 36 is located in the second flow path 18 at a point intermediate the two ends 19 and 22 of that flow path. Each reciprocating pumping means 34 and 36 is formed from a fluid reservoir and a piston. Specifically, the first reciprocating pumping means 34 includes a cylindrical enclosure or first cylinder 38 having one open end. The open end is plugged by a piston 40 (alternatively referred to as the "first piston" since it fits within the first cylinder 38). The closed end of the cylinder 38 has an opening 42 that is in flow communication with the body fluid flow path 10. This opening 42 defines the "inlet" and the "outlet" of the first reciprocating pumping means 34. Likewise, the second reciprocating pumping means 36 is formed from a second cylinder 35 having an open end and a closed end. The open end is plugged by a piston 44. The closed end has an opening 46 that is in communication with the second flow path 18. The opening 46 at the end of the second reciprocating pumping means 36 defines the "inlet" and the "outlet" of the second reciprocating pumping means. As the name implies, the pistons 40 and 44 in each of the two cylinders 35 and 38 are driven reciprocally along the longitudinal axis of the enclosures to induce the transfer of fluid. These two pistons 40 and 44 are driven by a motor means 48 which will be explained in detail at a later point in this discussion. How each reciprocating pumping means 34 and 36 produces pumping action so as to transfer fluid will now be explained. Since each of the two reciprocating pumping means 34 and 36 operates in essentially the same manner, only one will be explained in detail. Turning to the first reciprocating pumping means 34 in the body fluid flow path 10, as the first piston 40 is drawn towards the open end of the cylinder 38 the internal volume of that cylinder in communication with the body fluid flow path 10 increases and fluid fills the first cylinder 38. This is referred to as the "intake" or "suction" portion of the stroke or reciprocating cycle of the first reciprocating pumping means 34. By examining FIG. 1 it should be appreciated that in order for fluid to be drawn into the first cylinder 38 from the body 14, the inlet valve means 26 has to be open and the outlet valve means 28 has to be shut. Once the piston 40 has been drawn to the end of the first cylinder 38, the suction stroke of the first reciprocating pumping means 34 is completed. In order for fluid to be forced from the first cylinder 38 into the collection means or chamber 11, the inlet valve means 26 has to be shut and the outlet valve means 28 has to be opened. Once these two valving means 26 and 28 are so positioned, the piston 40 can be forced inwardly towards the closed end of the first cylinder 38. When this is done the fluid contained within the first cylinder 38 is forced out of that cylinder through the body fluid flow path 10 into the collection means 11. Thus, as long as the piston 40 is reciprocated and the inlet valve means 26 and outlet valve means 28 are controlled in the manner described above, fluid will be continually pumped from the interior of the patient's body 14 into the collection means 11. The second reciprocating pumping means 36 operates in the same manner as the first reciprocating pumping means 34. Since the discharge or outlet 22 of the second flow path 18 joins the first flow path 10 upstream of the first reciprocating pumping means 34, the second reciprocating pumping means 36 discharges fluid when the first reciprocating pumping means is drawing in fluid from the body of the patient 14. In other words, the first reciprocating pumping means 34 and the second reciprocating pumping means 36 are operated "180 degrees out of phase". Thus, the body fluid and additive fluid are mixed together during the suction stroke of the first reciprocating pumping means 34. The motor means 48 insures that the correct "timing" or phase relationship between the two reciprocating pumping means 34 and 36 are maintained in the proper synchronous relationship. It should be understood that if fluid is being drawn by the first reciprocating pumping means 34 from the body of the patient 14 at the same time that the second reciprocating pumping means 36 is discharging additive fluid into the first or body fluid flow path 10, that the two fluids are mixed at the confluence 24 of the two flow paths. Thus, by maintaining the two pumping means 34 and 36 in the correct time and phase relationship, additive fluids (such as an anticoagulant) can be added to a body fluid (such as lymph drawn from the thoracic duct) in a preselected proportion so as to produce a predetermined mixture of additive fluid and body fluid. This mixture is then discharged out of the end 13 of the first flow path 10 that is joined to the collection chamber 11. The proper mixture or concentration of the two fluids is determined by the amount of additive fluid discharged by the second reciprocating pumping means 36 in relation to the amount of body fluid drawn by the first reciprocating pumping means 34. Either the stroke of the pistons 40 and 44 or the size of the cylinders 35 and 38 may be changed to control the concentration of the mixture of body fluid and additive fluid. In particular, by forming the pistons 40 and 44 and cylinders 35 and 38 from readily available disposible syringes of different sizes, the flow rate and concentration of the mixture of additive and body fluid may be easily regulated. All that one needs to do to change the reciprocating pumping means from one size to another is to change the size of the syringe used. The motor means 48 will now be described. As previously explained, the function of the motor means 48 is to stroke the two pistons 40 and 44 in each of the two reciprocating pumping means 34 and 36 and operate the inlet valve means 26 and 30 and the outlet valve means 28 and 32 in each of the two flow paths 10 and 18. Preferably, the motor means 48 is carried by the frame 9 in such a manner that the major components 8 can be strapped to the patient (by a strapping means 200A, 200B) without unnecessarily immobilizing the patient. As shown in FIG. 1 the two pistons 40 and 44 are reciprocated by a linkage that is a variation of a "Scotch Yoke." Specifically, a crank 50 is rotated at a uniform angular velocity by a shaft 52 joined to an electric motor (not shown). Batteries can be used to power the electric motor. When the frame 9 is joined to the patient's body, the batteries can be carried in a belt worn by the patient. Such an arrangement allows the patient some freedom and does not unduly restrict him to a fixed position (such as a bed). The free end 54 of the crank fits within a yoke 55. One end 56 of the yoke 55 is joined to a connecting rod 58 attached to the first piston 40. The opposite end 60 of the yoke 55 is joined to a connecting rod 62 attached to the second piston 44. The yoke 55 is constrained by guides (not shown) to move in a direction perpendicular to its length. The connecting rods 58 and 62 are joined to the yoke 55 by a connection means 57 and 59. As shown in FIG. 3A the connection means 59 is a tongue and groove arrangement. The tongue 47 is attached to the rod 58 and the complementary groove or slot 49 is attached to the yoke 55. This allows the connecting rod 58 to by quickly joined to the yoke 55 without any special tools. The frictional fit between the tongue 47 and groove 49 holds the connecting rod 58 secured to the yoke 55. As previously mentioned, the reciprocating pumping means 34 may be fabricated from a disposible syringe. The discharge port or opening 42 of the syringe barrel or cylinder 38 is frictionally joined to the first flow path 10 by simply slipping the female opening 43F of the "T-connection" 45 over the male opening 43M of the syringe barrel or cylinder 38. This technique allows the flow capacity of the two reciprocating pumping means 34 and 36 to be quickly and easily changed. Furthermore, it allows components to be easily changed should they fail or become inoperative. Alternatively, the flow capacity of the two reciprocating pumping means 34 and 36 may be adjusted by varying the speed of the motor rotating the shaft 52. A reduction gear and a variable speed transmission are two other devices which may be used to adjust the speed of the shaft 52 and thus the flow capacity of the two reciprocating pumping means 34 and 36. Another mechanism or linkage that can be used to stroke the two pistons 40 and 44 in the two reciprocating pumping means 36 and 38 is shown in FIG. 4. Just as in the mechanism previously described, a crank 50 is rotated at a uniform angular velocity by a shaft 52 joined to a motor (not shown). Please note that the crank 50 in FIG. 4 is rotated counterclockwise. The free end of the crank 54 fits within a slotted link 70. One end 72 of the slotted link 70 is pivotally joined to a fixed point on the frame 9. The opposite end 74 of the slotted link 70 is joined to the connecting rod 58 joined to the first piston 40. A similar linkage 70' is provided to operate the second reciprocating pumping means 36. Those skilled in the art of mechanical linkages and mechanisms will recognize this as being a "quick return linkage." Specifically, such a linkage produces reciprocating motion such that the stroke in one direction is faster than the stroke in the opposite direction. As shown in FIG. 4, as the crank 50 rotates counterclockwise from the nine o'clock to the three o'clock position, the speed of the free end 74 of the slotted link 70 is greater than the speed of the free end when the slotted link is rotated counterclockwise from the three o'clock to the nine o'clock position. Since the crank 50 is rotated at a uniform speed, the free end 74 of the slotted link 70 must of necessity move at a slower speed when the free end 54 of the crank 50 is at its farthest distance from the fixed end 72 of the slotted link 70 relative to the speed at which the free end of the slotted link moves when the free end of the crank is closest to the fixed end of the slotted link. One advantage of a quick return linkage is that the linkage insures that fluid is drawn slowly into the first cylinder 38 while fluid is discharged from the first cylinder at a relatively higher flow rate. Drawing in fluid from the patient's body 14 slowly tends to minimize the pressure transient imposed on the duct in the patient's body from which the fluid is taken. As shown in FIG. 4, a second quick return linkage 70' is used to operate the second reciprocating pumping means 36. There a separate crank (not shown) operates the second linkage 70'. A single crank may be used to position both linkages 70 and 70'. As explained previously, the sequencing of the inlet valve means 26 and 30 and the outlet valve means 28 and 32 must be synchronized with the operation of the pistons 40 and 44 in the first and the second reciprocating pumping means 34 and 36 if additive fluid is to be mixed with the body fluid before the mixture is discharged to the collection flask 11 by the first reciprocating pumping means 34. In FIGS. 1, 3, and 4 a cam and follower mechanism is used to synchronize the operation of the valve means in relationship to the pumps. Specifically, the shaft 52 drives a cam 80 having two lobes 79 and 81 which in turn position a pair of spring loaded followers 82 and 84. Since each of the followers are of identical construction only one, the first follower, 82 will be described in detail. It should be noted, however, that two cams may be employed, one for each follower. The two cams may be arranged so that the actuation of the inlet and outlet valve means "overlap" (i.e., a certain amount of "dwell" can be introduced) during which time both inlet and outlet valve means in any one of the flow paths 10 and 18 are open or both are shut. For example, by having both the inlet and the outlet valve means 26, and 28 shut in the body fluid flow path 10 before the outlet valve means 28 is opened, there is no point in time that, in the event the motor driving the shaft 52 should fail, an unobstructed fluid path is formed between the duct in the patients body 14 and the collection means 11. It is conceivable that a "siphon effect" could be produced if both valves are open and the two pumping means are stopped whereby the fluid in the collection chamber 11 or in the reservoir 20 of additive fluid would "back-flow" into the patients body 14. Those skilled in the art should consider this possibility in making the apparatus that is the subject of this invention. The first follower 82 (see FIG. 1) is formed from a link 85 pivoted at a point 86 intermediate its ends. One end 87 of the link 85 is rotatably joined to a roller 88 by a pin 89. A spring or biasing means 90 holds the roller 88 against the cam 80. Thus, as the cam 80 is rotated the roller 88 is forced inwardly and outwardly relative to the center of the cam by virtue of the spring 90 pushing the link 85 against the two lobes 79 and 81 of the cam. In the embodiments illustrated in the figures, the valving function at the inlets 12 and 19 and the outlets 13 and 22 of the two flow paths 10 and 18 is produced by squeezing or pinching together the walls of a flexible tube when flow must be cut off and relaxing or releasing the pinched tube when flow is to be restored. Since each of the valve means 26, 28, 30 and 32 functions in the same manner only one 26 will be described in detail. At this point, it should be mentioned that one or more of the valve means may be a check valve (i.e., spring loaded, lift check, etc.). Check valves suitable for this service are known to those skilled in the art. Illustrations of typical check valves are found in laboratory and hospital equipment catalogs. The suction and discharge forces that are produced by the first and second pumping means 34 and 36 are used to actuate the associated check valves. One advantage of using check valves is that one or both follower mechanisms 82 and 84 may be eliminated. However, a check valve may produce a greater pressure drop than a similar length of plastic tubing. Consequently, the amount of fluid pumped may be reduced when check valves are employed. One advantage of employing a check valve as the valve means 92 at the inlet to the body fluid flow path 10 is that a check valve will automatically isolate the duct (from which the apparatus is drawing fluid in the patient's body 14) from the first and second reciprocating pumping means 34 and 36 in the event a high pressure condition is developed downstream the check valve. This would occur whether or not the motor means 48 is in operation or the pressure sensor means 75 (to be described in detail at a later point in this discussion) operates to shut off the first and second pumping means 34 and 36. The preferred embodiments are illustrated in the drawings and those embodiments do not employ check valves. Referring to FIG. 1 the inlet valve means 26 at the inlet end 12 of the first or body fluid flow path 10 includes a stop or abutment 92 fixed to the frame 9, a length of flexible tubing 93 and a pinching means 94. The pinching means 94 pushes the walls of the flexible tube 93 against the stop 92 to cut off flow. When flow is to be restored the pinching means 94 moves sufficiently far from the stop 92 to allow the walls of the flexible tube 93 to expand thereby restoring flow. As shown in FIGS. 1 and 2, the pinching means 94 is a protruberance at the free end of the pivoted link 85 forming part of the first follower 82. Thus, as the cam 80 operates the follower 82, the protuberance or pinching means 94 is pushed towards and away from the walls of the tube 93 in such a manner as to sequentially cut off and restore flow. It will be recalled that the first reciprocating pumping means 34 operates 180 degrees out of synchronization with the second reciprocating pumping means 36. As a consequence, the inlet valve means 26 to the first or body fluid flow path 10 is shut when the inlet valve means 30 to the second flow path 18 is opened (See FIG. 1). Similarly, the outlet valve means 28 for the first or body fluid flow path 10 is open when the outlet valve means 32 on the second flow path 18 is shut. This relationship is reversed when the first reciprocating pumping means 32 and the second reciprocating pumping means 36 change directions (see FIG. 2). Because of this relationship the same pinching means 94 can be used to cut off and restore flow for both inlet valve means 26 and 30. The same is true for the outlet valve means 28 and 32, that is, the same pinching means 94' can operate both valves. Referring to FIGS. 1 and 2 and to the cam 80 and the two follower mechanisms 82 and 84 illustrated there, and remembering that for any one flow path 10 or 18, the inlet valve means 26 or 30 is always positioned opposite to the corresponding outlet valve means 28 or 32, it should be apparent that the rollers 88 and 88' are positioned relative to the cam lobes 79 and 81 in such a manner that one of the rollers rests on the outer lobe 81 whenever the other roller is on the inner lobe 79. It should be appreciated from the foregoing discussion that any combination of the various linkages described can be used to produce the same effect. For example, FIGS. 1 and 2 illustrate the use of a cam and two follower mechanisms 82 and 84 to position the inlet 26 and 30 and outlet 28 and 32 valve means, and a modified version of a Scotch Yoke to operate the first and second reciprocating pumping means 34 and 36. On the other hand, FIG. 4 illustrates the use of a cam and two follower mechanisms 82 and 84 to position the inlet 26 and 30 and the outlet 28 and 32 valve means, and a variation of a quick return linkage to position the first 34 and second 36 reciprocating pumping means. Other variations and combinations may be used. The last component to be described is the fluid pressure sensor means. The fluid pressure sensor means 15 is positioned in the body fluid flow path 10 downstream the inlet valve means 26 and upstream the first reciprocating pumping means 34. FIG. 3A is an enlarged detailed view of the fluid pressure sensor means 15 shown in FIGS. 1, 2, and 4. The function of the fluid pressure sensor means 15 is two-fold: (1) It reduces the pressure surges induced in the upstream end 12 of the body fluid flow path 10 and in the duct in the body of the patient 14 to which the first reciprocating pumping means 34 is attached; and (2) It shuts off the motor means 48 in the event that an abnormal pressure condition is created or detected in the upstream end 12 of the body fluid flow path. The fluid pressure sensor means 15 has two major components: a variable volume chamber 100; and a switch means 102. The variable volume chamber 100 has an inlet 104 and an outlet 106. One wall 108 of the chamber 100 is formed from a material having a high coefficient of flexibility. In other words, this wall 108 will expand to a greater degree than the walls forming the inlet 104 or the outlet 106 of the chamber 100 or the walls of the tubing forming the body fluid flow path 10. In addition, this wall 108 preferably should have a higher coefficient of flexibility than that of the duct or passageway in the patient's body 14 to which the inlet 12 of the body fluid flow path 10 is connected. This latter characteristic insures that variable volume chamber 100 expands and contracts to a greater degree than the duct or passageway in the patient's body 14. The concern is that surges induced by the first reciprocating pumping means 38 may be transmitted to the relatively thin and fragile walls of the duct in the patient's body 14 to which the apparatus is attached. If the pressure imposed upon the walls of the duct in the body is sufficiently high, those walls may be ruptured. Conversely, if a high suction or negative pressure is produced on the walls of the duct, those walls may implode or collapse. If the wall 108 of the variable volume chamber 100 responds to pressure forces before the thin, fragile walls of the duct are flexed or pressurized, the duct is in effect protected from these pressure surges. The second component of the fluid pressure sensor means 15 is the switch means 102. The switch means 102 is joined to the flexible wall 108 of the variable volume chamber 100 by a connecting rod 110. As shown in FIG. 3A, if a negative pressure were created at the inlet 12 to the body fluid flow path 10, the flexible wall 108 would collapse or would be drawn inwardly as shown by the dotted line and the downwardly directed arrows. If this condition is allowed to continue unabated, the walls of the duct in the patient's body 14 could collapse. The switch means 102 is used to interrupt power going to the motor driving the shaft 52 which is used to operate the two reciprocating pumping means 34 and 36 and the valve means 26, 28, 30, and 32. As illustrated in FIG. 3A the switch means 102 includes: a connecting rod 110 joined at one end to the flexible wall 108 of the variable volume chamber 100. The opposite end of the connecting rod 110 carries a bridge wire 112. The connecting rod 110 is free to move reciprocably through an opening 114 in a terminal board 116 attached to the frame 9. Two wires 118 and 120 are joined to the terminal board 116. When the bridge wire 112 connects together these two wires 118 and 120, an electrical circuit (not shown) is completed that shuts-off power to the motor means 48. Another variation to this circuit is shown in FIG. 3B. The fluid pressure sensor means 15' shown in FIG. 3B employs a cylinder 101 opened at one end to form the variable volume chamber 100'. A piston 108' closes off the open end of the cylinder 101. Thus, as pressure increases or decreases in the upstream end 12 of the body fluid flow path 10, the piston 108' is driven inwardly or outwardly relative to the cylinder 101. Here, the switch means 102' has a second bridge wire 112' attached to the lower end of the connecting rod 110. The second bridge wire 112' completes the electrical path between the two wires 120 and 118 when the variable volume chamber 100' is driven outwardly. This could occur, for example, when the pressure in the upstream end 12 of body fluid flow path 10 is increasing or driven beyond a predetermined acceptable value. One cause for this could be an obstruction in any one of the lines forming the body fluid flow path 10 downstream of the first reciprocating pumping means 34. Effectively, the fluid would be forced to back flow into the upstream end 12 and back into the patient's body 14. Thus, the fluid pressure means 15' acts to shut off the motor means in the event of abnormally high pressure or an abnormally low pressure in the upstream end 12 of the body fluid flow path 10. Other variations of the switch means 102 may be used. For example, the connecting rod may be joined to a wiper arm to which one 118 or 120 of the two wires 118 is directly connected. The wiper arm is driven reciprocally across a fixed conductor or contact bar joined directly to the other wire 120 or 118. In this circuit, current flows between the two wires 118 and 120 so long as the wiper arm lies between two ends of the contact bar. If the pressure in the variable volume chamber 100 becomes too high, the wiper arm is driven off one end of the contact bar. This interrupts the current flow to the motor means 48. Similarly, if the pressure in the variable volume chamber 100 becomes too low, the wiper arm is driven off the other end of the contact bar and the circuit between wires 118 and 120 is interrupted; again the motor means 48 is shut off. Other variations in the switch means 102 and the variable volume chamber 100 should be apparent to those skilled in the art from the foregoing description. The overall operation of the invention will now be described. FIG. 1. illustrates the various components, linkages and valves at the end of the discharge stroke of the first reciprocating pumping means 34 and the end of the suction stroke of the second reciprocating pumping means 36. Consistent with these conditions the inlet valve means 26 in the body fluid flow path 10 is shut and the outlet valve means 28 for the body fluid flow path is open. Similarly, the inlet valve means 30 for the second flow path 18 is opened and the outlet valve means 32 for the second flow path 18 is shut. As the motor (not shown) drives the shaft 52 clockwise, the crank 50 is also driven clockwise. Consequently, the yoke 55, driven by the free end 54 of the crank 50, is driven from the right to the left end of the frame 9. This drives the piston 40 in the first reciprocating pumping means 34 outwardly and the piston 44 in the second reciprocating pumping means 36 inwardly. Simultaneous with the movement of the yoke 55 the double lobed cam 80 is rotated clockwise. As the cam 80 is driven clockwise, the first follower 84 is repositioned from the inner lobe 79 to the outer lobe 81. Conversely, the second follower 82 is repositioned from the outer lobe 81 to the inner lobe 79. Repositioning the two followers 82 and 84 repositions the inlet valve means 26 and 30 and the outlet valve means 28 and 32 in the two flow paths 10 and 18. Repositioning the valves as indicated above is consistent with the first reciprocating pumping means 34 drawing fluid from the patient's body 14 and the second reciprocating pumping means 36 forcing additive fluid into the body fluid flow path 10 at the confluence 34 of the two flow paths 10 and 18. FIG. 2 illustrates the position of the various components at the end of the suction stroke of the first reciprocating pumping means 34 at the end of the discharge stroke of the second reciprocating pumping means 36. Again, consistent with the discussion above, the inlet valve means 26 to the body fluid flow path 10 is open and the inlet valve means 30 to the second flow path 18 is shut. Also, the outlet valve means 28 for the body fluid flow path 10 is shut and the outlet valve means 32 of the second fluid flow path 18 is open. The flow of fluid is indicated by the arrows. Continued clockwise rotation of the shaft 52 will drive the yoke 55 from the left to the right which forces fluid out of the first cylinder 38 into the collection means 11 and draws fluid into the second cylinder 35. Since the mixture of body fluid and additive fluid is discharged at a positive pressure, the mixture can flow through components such as filters, membranes, etc. located downstream the outlet end 13 of the body fluid flow path 10. Continued clockwise rotation of the cam 80 will result in the two followers 82 and 84 repositioning such that the valves will shift position to that shown in FIG. 1. This cycle will be repeated as long as the motor means 48 continues to operate. If at any time the pressure in the inlet 12 to the first reciprocating pumping means 34 becomes abnormal, the fluid pressure sensor means 15, 15' will be actuated to shut off the motor means 48 which shuts down the entire apparatus. A suitable warning device (not shown) can be provided to alert personnel of the problem so that they may take remedial action. Once the problem is corrected the motor means 48 can be reactivated and pumping cycle continued. Thus, it is apparent that there has been provided in accordance with the present invention, a unique and novel apparatus suitable for use in drawing fluid from a patient's body which at the same time mixes with that fluid an additive in a prescribed proportion so long as the apparatus is in operation. Inherent design features are not only provided to insure that fluid is properly drawn from the body but also features are provided to shut off the apparatus in the event that an abnormal pressure condition is created or detected. While the invention has been described in conjunction with certain specific embodiments, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing detailed description. Accordingly, it is intended to cover all such alternatives, modifications, and variations as set forth within the spirit and broad scope of the appended claims.

1a

BACKGROUND DESCRIPTION OF PRIOR ART Innovation has always been the way to promote more efficient living. Inventions such as electric appliances, and microwave ovens have made our lives easier; Computers and facsimile machines have saved us time. Everywhere we turn technology has made our lives better. The disclosed invention follows in these historic footsteps, and makes everyday life simpler. This invention makes the process of cleaning ones home more enjoyable. The design of home vacuum cleaners have not changed much in the last 70 years. Some of the original designs, like the Royal Upright, have not changed much since the 1920's, and still outperforms many of the newer models. Recently however, a major change has taken place in the vacuum cleaner market. The incorporation a vacuum hose along with an upright vacuum cleaner has spread throughout the market. This is no surprise since having a hose and its attachments at hand allows the user to easily switch from one mode of cleaning to another. No longer does one have to attach a clumsy cover over the beater bar opening to attach a hose. This switch to multipurpose vacuum cleaners, however, has seen very little redesign of the nozzle attachments. The crevice, upholstery, and dust brush nozzles have not changed much since they were invented. A crevice tool is still a long narrow tube for getting into small openings like the space between seat cushions, while an upholstery tool is still designed with a long rectangular nozzle for cleaning a fabric surface quickly. And a brush tool is still a ring of bristles around a vacuum port for cleaning dust off of hard surfaces without scratching. These three tools have been the mainstay of the vacuum cleaner industry for decades. Only recently have people begun to combine these tools. U.S. Pat. No. 4,688,294 to Simonsson on Aug. 25, 1987 shows a vacuum nozzle with two functions: a brush tool and an upholstery tool. The design is basically comprised of two separate tools which have been joined together. Each tool has its own nozzle port and its own cleaning duct. U.S. Pat. No. 2,815,525 to Lofgren on Dec. 10, 1957, U.S. Pat. No. 3,108,311 to House on Oct. 29, 1963, and U.S. Pat. No. 4,897,894 to Fahlen on Feb. 6, 1990, combines a dust brush with an upholstery tool like Simonsson's device, but uses a single air passageway for both tools. With the use of folding arms these three devices convert the upholstery tool into a nozzle inlet. This arrangement saves space, and makes the tool very compact. Unfortunately, none of these tools have a way to clean sharp corners, edges, or crevices. One must use other nozzles to perform these cleaning tasks, a significant disadvantage. Other devices such as, U.S. Pat. No. 4,459,720 to Ahlf on Jul. 17, 1984, U.S. Pat. No. 4,506,406 to LaMonte on Mar. 26, 1985, and U.S. Pat. No. 4,694,529 to Choiniere on Sep. 22, 1987 combine different forms of crevice and upholstery tools. Choiniere's device does not even bother to seal one tool from the other, both are open to the same air flow. This two opening tool configuration reduces the effectiveness of both tools, making it practically useless except in very specific tasks. Ahlf's device is basically two tools joined together, each with its own air duct. The design has the aspiration of each tool selectively by actuating the suction hose respective to the nozzle. This feature makes it easier to use, but requires a valve flap and a flexible joint. Both of which make the tool more prone to failure and complicated. LaMonte's tool solves half the air direction problem with a sliding door, but the side mounted upholstery tool is extremely awkward for most items. Our five-function vacuum cleaner nozzle provides a simple and highly functional tool that combines all 3 of the major vacuum nozzle tools, plus an added advantage of being convertible into a corner tool and an edge tool. No other vacuum cleaner nozzle combines so many functions. The user may clean upholstery, or crevices, or edges, or stair corners, or hard surfaces without having to returning to the vacuum cleaner to change tools. The problem of running back and forth to the vacuum cleaner has been solved. Our vacuum nozzle has the added advantage of being extremely compact. It has the same number of parts and is approximately the same size and shape as Fahlen's invention, (a commercially successful two-function tool). The small size of our vacuum nozzle seems to defy the incredible increase in functionality over Fahlen's invention. Our five-function vacuum nozzle is compact enough to be placed right on the handle of the vacuum hose for immediate use. OBJECTIVES AND ADVANTAGES Accordingly, several objects and advantages of our invention are: a) The integration of 5 separate vacuum cleaner nozzles into a single compact unit. b) The use of a single air passageway for all five tool functions. c) All 5 tools are scaled off from each other when in operation. d) Tool has a convenient bend in it so that it is easy for the tool to be angled against a surface. e) Requires less plastic than would be needed to make five separate nozzle tools, thus saving resources. f) Tool arms can be angled between zero and 180 degree for cleaning corners, such as the lip on carpeted stairs. g) Tool has openings at the ends of the upholstery tool, creating a high speed air flow, for better cleaning. i) The openings on the ends of the arms while in upholstery configuration not only provide better air flow for picking up dirt, but also produce an edge cleaning effect. j) And, because all five tools are in one, they take up less space. This allows for a smaller, more compact, vacuum cleaner design. The space savings could be used to allow other cleaning equipment to be placed on the vacuum. Possible accessories could include, a dust cloth, spray bottle, extra bags for the vacuum cleaner, and etc. k) Finally, the dust brush is removable and can be replaced with any number of other tools. To do floors one could attach a floor brush. Or if a very long crevice tool is needed, it could be attached. These nozzle attachable tools further extends the functionality of this tool. DRAWING FIGURES FIG. 1 Section view of the Four-function nozzle in corner tool position with phantom lines showing some possible arm positions. FIG. 2 Side view of the Four-function nozzle in section. FIG. 3 Perspective view of Four-function nozzle. FIG. 4 Detailed view of Pivotal Cleaning Arms. FIG. 5A Section view of the Five-function nozzle in Dust-Brush configuration. FIG. 5B Section view of the Five-function nozzle with a floor brush attachment installed. FIG. 6 Front section view of the Five,function nozzle in Corner tool configuration. FIG. 7 Section view of the Five-function nozzle in Crevice tool configuration. FIG. 8 Perspective view of the Five-function nozzle in Upholster/Edge configuration, with crevice tool configuration shown in phantom lines. FIG. 9A Section view of alternative Five-function nozzle. FIG. 9B Alternate five-function nozzle in crevice/upholstery configuration. FIG. 10 Perspective view of alternative Five-function nozzle Arm. FIG. 11 Side view of alternative Five-function nozzle in section. ______________________________________DRAWING REFERENCE NUMBERS______________________________________2 Nozzle housing (4-function) 4 Suction conduit6 Cleaning Arms 8 Suction Passageway10R Housing friction ridges 10L Housing friction ridges12F Front sealing flange 12B Back sealing flange14 Conduit receiving port 16 Tool end of housing18 Conduit stop 20 Arm pivot pegs (2 per arm)22 Bevel on end of arms 24 arm channel26 Fiber picking edges 28 Arm friction ridges30 Pivot holes (4 total) 32 Guard tabs34 Arm stops 35R Arm stop (Right)35L Arm stop (left) 40 Nozzle housing (5-function)41 Upholstery surface 42 Attachment recess43 Bristle retainer 44 Dust brush45 Bristles 46F Front sealing flange46B Back sealing flange 47 Retainer gripping handle48R Range of motion (Right arm) 48L Range of motion (Left arm)50 Second conduit port 52 First conduit port54 Third port (tool end) 55 tabs56 Tabs 57 Flexible skirt58 Contact line 60 Contact edge62 Lip 64 Holes68 Port 50 axis line 70 Port 52 axis line72 Arm stops 74 Friction ridges80 Floor brush housing 82 bristles84 Air Channel 86 Connecting tube88 Attachment ring 90 Alternate housing92 Bristles 94 Cleaning arm96 Arm stop 98 Arm stop100 Arm pegs 102 Friction ridges104 Indentation 106 Tabs108 Arm wing 110 Air channel112R Friction ridges 112L Friction ridges114F Front flange 114B Back flange116 Lip 118 Dust brush port120 Upholster/crevice port 122 Center axis for port 118124 Center axis for port 120 126 Brush attachment skirt128 Conduit stop 132 Peg holes134 Extension 136 Hub138R Right tongue 138L Left tongue______________________________________ DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The description presented here is organized in a logical manner. The discussion will start with the four-function vacuum cleaner nozzle. Then we will move on to the five-function nozzle, which incorporates the four-function nozzle into its design, and finally, we will present an alternative housing and arm design for the five-function nozzle. Four-Function Nozzle FIGS. 1 to 4 FIG. 1 shows a section view of a four-function vacuum cleaner nozzle in corner tool configuration. Phantom lines show several other positions for cleaning arms 6. The vacuum nozzle consists of three main parts: a nozzle housing 2, and a right and left cleaning arms 6. Nozzle housing 2 is designed with a conduit receiving port 14, and a tool end 16. Receiving port 14 consists of a cylindrical tube designed to be attached on a suction conduit 4. The suction conduit is a suction communicating device such as a vacuum cleaner hose. The tool end is fashioned for mounting of two pivotal cleaning arms 6. A pair of friction ridges 10R and 10L interact with friction ridges 28 to provide many stable positions for the arms. Also on the tool end of housing 2 are a pair of sealing flanges 12F(front flange, not shown) and 12B(back flange). These flanges seal in vacuum air from escaping between the two arms. Conduit stop 18 prevents conduit 4 from being inserted too far into housing 2. Thus, stop 18 prevents conduit 4 from binding with arms 6. FIG. 2 shows the angled nature of housing 2. This angle is optional, but an angle around 45 degrees makes it easier to properly place the tool on most items to be cleaned. Pivot holes 30 are formed in the base of flanges 12F and 12B. Two pair (4 total) of these pivot holes provide a rotatable connection for pivot pegs 20 which protrude from each side of arms 6. FIG. 2 shows arms 6 attached to housing 2. The left and right arms are identically constructed. This allows for easier manufacturing since only one mold is needed. Both arms are installed in housing 2 with channels 24 facing each other. The connecting of pegs 20 into holes 30 allow the arms to be rotated through an approximately 90 degree arc. The arms are made from any moldable material. A hard plastic works very well, though other materials could easily be used. Tab 32 and stop 34 protrude from the base of each arm. These protrusions help keep soft fabric material, such as drapes, from being sucked down suction passageway 8 when cleaning in upholstery tool configuration (FIG. 3). As seen in FIG. 2, tab 32 and arm stop 34 are purposely positioned asymmetrically. The staggered positioning allows them to mesh when rotated. This prevents binding, and prevents such things as curtains from being sucked into the housing. Each arm has a "U" shape to it when looking down its length, forming a tapered channel with open ends. This shape forms channels 24 in which suction air may flow. In FIG. 3 we see a perspective view of the four-function tool with the arms extended horizontally to be used as an edge or upholstery tool. Arms 6 are positioned to the sides forming a flat working surface for the fiber picking edges 26. These edges are designed to enhance the effectiveness of the nozzle. The fiber picking edges may be designed in several ways. For example, the edges could be coated with a resilient material such as rubber. This rubbery edge helps pull stubborn fibers away from fabrics so they may be sucked away more easily. Other possible edge would be a short whisker brush, or just a textured plastic surface. Edges 26 would increase friction, and thus, help pull fibers into channel 24 to be sucked away. FIG. 4 shows arms 6 removed from the housing and in a united position where they are parallel to each other with the working surfaces opposed to each other. Pegs 20 protrude from the sides of each arm at its inner end. The positioning of the pegs is such that when installed in a housing edges 26 come together as shown. This allows the formation of a single enclosed passageway down the center of the two arms. On the inner portion of each arm is a stop 34 and a tab 32. Also on the inner end of the arms are friction ridges 28. These ridges are placed at a constant distance from the pivot pegs and extend around these pegs for approximately 90 degrees. The arms narrow toward the outer end, and end at beveled end 22. Five-Function Nozzle FIGS. 4 to 8 The five-function vacuum cleaner nozzle adds one more feature and one more part to the four-function nozzle, that is, a dust brush. The five-function nozzle consists of four main parts which are; a nozzle housing 40, a dust brush 44, and two cleaning arms 6. Notice the arms are identically to those used on the four-function nozzle. This five-function design is the most preferred configuration of the disclosed vacuum nozzle. In FIG. 5A we see housing 40 in section. The housing has three ports labeled 50, 52, and 54. These three ports all intersect forming a connected suction passageway through the interior of housing 40. Ports 50 and 52 have the same diameter so they alternately accept suction conduit 4. Port 54 is basically the same structure as found on the four-function nozzle, with arm pegs 20 fitting into holes 64. Also on port 54 are front and back flanges 46F and 46B, which seal the junction area between the two arms, and thus form a continuous channel when in upholstery configuration. When conduit 4 is inserted into port 50, the end of conduit 4 seals against the inside wall of port 52 with an arc shaped contact line 58 (see FIG. 5B). This arrangement forms a tight seal so that port 54 is closed off from port 52. In FIG. 5B we see ports 50 and 52 both have a cylindrical shape. The intersection of these two ports is such that center axis 68 of port 50 intersects center axis 70 of port 52, but does not pass through port 52. Port 50 extends into port 52 only far enough for the outer edge of the cylinder inscribed by axis 68 to touch the back wall of port 52 at contact line 58. Notice line 58 is drawn above the projection line for axis 68. In actuality line 58 would follow this projection line, but for clarity it has been drawn the way it is so it is seen. All three ports 50, 52, and 54 are connected near the center of housing 40. Port 50 comes down from the right and port 52 straight up from below, while port 54 angles up to the left. FIG. 6 shows a section view from the front of the five-function nozzle. The dashed line marked 50 shows the rim of port 50 as if it were not cut away for the section view. The housing is constructed as a single injection molded part, and must be pliable enough to allow friction ridges 28 and 74 to slip past each other, as well as, flexible enough to insert arms 6 between flanges 46F and 46B. Friction ridges 74 are defined on each side of housing 40 and interact with ridges 28 to provide several stable positions for arms 6. Stops 72 on each side of housing 40, limit the rotation of each arm, so the arms form a rigid upholstery tool when folded horizontal. In FIG. 7 we see the same nozzle with the conduit inserted into port 52. The conduit seals against an arc shaped contact edge 60 on the inside extreme of port 50. The contact edge 60 matches the cylindrical shaped end of conduit 4, so port 50 is sealed off from the other two ports when the conduit is inserted. We also see, that holes 64 are placed far enough away from contact edge 60, so that tab 32 and stop 34 do not bind against conduit 4 when it is inserted into port 52 (as shown). In FIG. 5A, dust brush 44 consists of bristles 45 which are held together by ring shaped retainer 43. The outside of retainer 43 is shaped to snap fit into attachment recess 42. The retainer extends down around the bristles to provide a gripping surface 47 for removing and installing the brush. Tabs 55 and tabs 56 are spaced around the inside of recess 42 to help dust brush 44 snap into place. With this design, different brushes may be attached (such as a floor brush, see FIG. 5B). The bristles surround the walls of port 52 and lip 62 help keep the bristles from jamming when suction conduit 4 is inserted into port 52 (FIG. 7). FIG. 8 shows a perspective view of the five-function tool in upholstery tool position. The outer end of each arm has a beveled end 22 to allow the nozzle to slide over fabric surfaces more easily when in crevice configuration (phantom lines). Notice how port 54 intersects the interior of port 50. This figure does not show suction conduit 4 fully inserted. If it were the end of the suction conduit would be touching contact edge 60. Alternate Five-Function Nozzle FIGS. 9A to 11 In FIG. 9A we see the alternate five-function vacuum cleaner nozzle in section. This nozzle consists of four main parts; a housing 90, a bristles 92, and a pair of cleaning arms 94. For simplicity we show bristles 92 molded into housing 90 at attachment skirt 126. This configuration makes the nozzle housing narrower, because there are no attachment brackets. This in turn allows arms 94 to rest closer to housing 90 when they are folded back to accept a suction conduit 4. The bristles could be attached in any number of ways, including, gluing, pressure fit, or snap fit as seen on the five-function nozzle. The bristle fibers may be natural or synthetic, and are stiff enough to effectively agitate dust from surfaces, stiffness depending on preference. In FIG. 9B we see the alternate nozzle in section. Arms 94, and bristles 92 are attached to housing 90. The housing is cylindrical shaped with an air passage through its center. Ports 118 and 120, both accept a suction conduit and connect the two ends of the nozzle. On the brush side of the nozzle, lip 116 forms a soft ring shaped end of the housing. This lip helps keep brush bristles out of port 118 and also helps guide a suction conduit into port 118. FIG. 10 shows a perspective view of alternate cleaning arm 94. Each arm has a pair of round pegs 100 at each end of cylindrical hub 136. Arms 94 are roughly "L" shaped (see FIG. 9A) when viewed from the side. With extension 134 and hub 136 forming the bottom portion of the "L" shape, and arm wing 108 forming the remainder. Arm wing 108 also defines an air channel 110 which extends the length of the arm. And friction ridges 102 are formed on hub 136 and follow the contour of indentation 104. In FIG. 11 we see housing 90 has two ports 118 and 120 with center-of-axis lines 122 and 124 respectively. The two ports form a junction with an angle approximately 45 degrees off from parallel. Stop 128 is molded into the interior wall of port 118. This protrusion prevents over insertion of a suction conduit into port 118 so that the suction conduit does not bind against arms 94. At port 120 the housing is designed to accept two cleaning arms 94. Holes 132 are formed in pairs at the base of flanges 114F and 114B. These hole pairs accept pegs 100 on the arms. The flanges extend above the holes and provide an air seal for the arms when they are in upholstery configuration. The flanges are made to rest flush against the sides of arms 94. At the base of flanges 114F and 114B and along the sides between them are a series of friction ridges 112R (see FIG. 9A) and 112L. In FIG. 11 we see the ridges are shaped to follow the contour of friction ridges 102 on arm 94. Tongues 138R (see FIG. 9B) and 138L in the center of ridges 112R and 112L seal air from escaping and also provide the surface for stop 96 and stop 98 interact with. OPERATIONAL DESCRIPTION Since there is a slight difference in operation between the different embodiments presented in this paper, we will present each embodiment separately. We will start with the four-function nozzle, then move on to the five-function nozzle, and finally finish with the alternate five-function nozzle. Four-Function Nozzle FIGS. 1, 3, and 6 FIG. 1 shows a section view of the four-function nozzle with cleaning arms 6 in position to be used as a crevice tool. A suction conduit 4 is inserted into a receiving port 14 of housing 2 until it reaches stop 18. Suction air is then communicated through passageway 8 to the cleaning arms. If arm 6 on the left is rotated vertically like arm 6 on the right, then channel 24 on each arm unite to form a single air passageway which focuses suction air to beveled end 22. The small width of end 22 allows the tool to get into small cracks and crevices to remove dirt and dust. To change the mode of operation the arms are moved to any of several positions. Two of the many possible positions are shown in phantom lines in FIG. 1. Stop 34 prevents each arm from rotating passed a vertical (crevice mode) position. Stops 35R and 35L are the counter stops for stop 34, and prevent the arms from rotating passed an in-line (upholstery mode) position. FIG. 3 shows both arms folded to the side so that channel 24 on each arm form one long continuous channel. This arrangement produces a nozzle that will function as an upholstery tool. Fiber picking edges 26 of each arm are rubbed back and forth across a surface. The sticking nature of the edges tend to ball up hair and fibers so they are more easily vacuumed away. Suction air moving down channel 24 sweep away any such fibers and removes them from the nozzle through conduit 4. FIG. 3 also shows the configuration for an edge cleaner. The open end of each arm provides a powerful suction force from channel 24 which easily pulls dust and dirt away from edges. The nozzle arm is simply moved along a surface with the end of one arm against the edge to be cleaned, vacuum air does the rest. FIG. 6 shows the five-function nozzle, however, the four-function nozzle in corner configuration operates in substantially the same way. In FIG. 6, arms 6 are be positioned to clean a curved edge; in this case, a right angled corner. By angling one arm vertically, and the other horizontally, a 90 degree angle is formed. Air channel 24 of each arm conducts suction air to the end of each arm, creating a fast moving stream of air across upholstery surface 41. Thus, when the nozzle is rubbed back and forth across surface 41, edges 26 help loosen fibers. Five-Function Nozzle FIGS. 5A TO 8 Lets first look at the dust brush operation. In FIG. 5A we see a section view of the five-function nozzle. Suction conduit 4 is inserted into port 50 so that vacuum suction is communicated to port 52 (dust brush). Because of the cylindrical shape of port 52, the front edge of conduit 4 nearly matches the arcing inner surface of port 52. This means that a nearly perfect seal is made between port 52 and conduit 4 at contact line 58. In tests, with housing 40 made from a slightly pliable material, a good seal was accomplished without any modifications to the inner wall of port 52. With the suction conduit inserted as shown in FIG. 5A, the dust brush is ready for use. Cleaning arms 6 may be placed in any position while using the dust brush, however, our preference is with the arms in crevice tool position as shown in this figure. Dusting is accomplished by moving the brush back and forth across the surface to be cleaned. Dust and dirt is then sucked up into port 52 and away through conduit 4. To change tools on port 52, one grips handle portion 47 of retainer 43 and pulls the dust brush off of housing 40. Then a new tool is installed. FIG. 5B shows how the dust brush is detachable and how a floor brush, or other tool, is snap fit into recess 42. The changing of tools is simply a matter of pulling one tool off and snapping the other in place. An attachment ring 88 on floor brush housing 80 snaps into place between tabs 56 and skirt 57. Connecting tube 86 extends brush housing 80 passed lip 62 to provide unobstructed air flow. For operation, a suction conduit would be inserted into port 50 to communicate suction to floor brush housing 80. Suction air is distributed to bristles 82 through channel 84. Agitating bristles 82 back and forth across a hard floor surface knocks dirt and debris loose, which is sucked away. Note in FIG. 5B that floor brush housing 80 is installed 90 degrees off of its normal operating orientation. For ease of use, the long axis of housing 80 should be perpendicular to axis 68 of port 50. Now lets look at the other end of the five-function nozzle where arms 6 are attached. FIG. 7 shows the five-function nozzle with suction conduit 4 inserted into port 52. In this position, conduit 4 communicates vacuum suction to port 54 (and ultimately to arms 6). Port 50 is closed off in this configuration, with conduit 4 sealing against contact edge 60. In FIG. 8 we see arms 6 are pivotal through 90 degrees between a position where edges 26 form a flat surface for cleaning upholstery, and a position where the arms come together in a substantially united position (see phantom lines) to form a crevice tool. Each arm may be moved independently and adjusted to any intermediate position to form an angled tool for cleaning such curved surfaces as stair corners. In upholstery configuration as shown in FIG. 8 the arms form a flat channel which is open at each end. When the arms are place down on a surface to be cleaned, air is sucked in through the ends of the arms. Thus, a fast moving passageway of air sucks dust and dirt away toward the center of the arms and up into port 54 and then way through conduit 4. FIG. 6 shows one possible configuration. In this drawing arms 6 forming a 90 degree angle for cleaning a corner. Channels 24 form two air passageways when arms 6 is placed against a right angled surface 41. Air then flows down channel 24 of each arm as arms 6 move along the surface. This air flow sucks dust and dirt away as the nozzle is moved back and forth across surface 41. Edges 26 help dislodge foreign material so that it may be vacuumed away. FIG. 7 and 8 show arms 6 in crevice tool position, (phantom lines in FIG. 8). In this position the two arms act as one. Force exerted on the side of either arm does not shift the crevice tool configuration. This is because stop 34 on each arm prevent the arms from going pass their forward facing position. Vacuum suction also helps hold the two arms together. Thus, the only way to separate the arms is to pull them apart. When the nozzle is being used as a crevice tool, it is sometimes slid back and forth sideways across a surface. With this type of motion there is the possibility that the trailing arm could catch on the surface and be pulled away from the other arm. To help prevent this, the end of each arm is beveled (end 22). Beveled end 22 help reduce friction as the tool is slid sideways across a surface, thus reducing the chances arms 6 will catch on the cleaning surface and be pulled apart. FIG. 8 also shows the configuration for an edge cleaner. The open end of each arm provides a powerful suction force from channel 24 when placed against a surface. The nozzle arm is simply moved along a surface with the end of one arm against the edge to be cleaned, vacuum air does the rest. Alternate Five-Function Nozzle FIGS. 9 TO 11 FIG. 9A shows the alternate L nozzle in section. Port 118 and port 120 are fashioned to accept a suction conduit. Conduit 4 is shown inserted into port 120. Arms 94 are rotated down and to the sides of housing 90. Indentation 104 (see FIG. 0) allows conduit 4 to slide passed the arms. Once conduit 4 is positioned as shown in FIG. 9A suction air is communicated to port 118 and then to bristles 92. With suction air flowing to bristles 92, cleaning is accomplished by sliding bristles 92 across a surface. This action agitates dust and dirt, which is then sucked up into port 118 and away through conduit 4. Lip 116 helps keep the bristle from getting pulled inside port 118. FIG. 9B shows the same view as FIG. 9A, but with suction conduit 4 inserted into port 118 and the arms in different working positions. Stop 128 restricts the depth to which conduit 4 is insertion. This prevents the end of conduit 4 from binding with tabs 106 on arms 94. Once the conduit is inserted suction air is communicated to port 120 and then to arms 94. FIG. 9B shows a few positions of arms 94 in phantom lines. By positioning arms 94 in different position they have different functions. With the arms forward facing (pointing up in FIG. 9B) the nozzle acts as a crevice tool. When the arms are horizontal (pointing away from each other) they function as an upholstery tool. In upholstery configuration the open ends of arms 94 act like small crevice tools, perfect for cleaning edges. And by adjusting the arms to intermediate positions, one may clean curved surface or corners. In upholstery configuration, arms 94 are horizontal. A single long air channel is formed by placing channel 110 of each arm in line with each other. Flanges 114F (shown in FIG. 11) and 114B seal suction air within channels 110 by closing off the open space between arms 94. When cleaning very flexible surfaces, such as drapes, tab 106 on each arm keep the drapes from being sucked into conduit 4. In FIG. 9B with both arms facing upward as the right arm, a crevice tool is formed. Suction air is conducted through port 120 and out through the air passage created by joining air channels 110 from each arm. Stop 96 prevents the arms from rotating passed the vertical position. By limiting the rotation the crevice tool formed by arms 94 is stable, and resists side forces. FIG. 10 shows a perspective view of the alternate arm 94. The most notable difference between this arm and the arm used on the other nozzle housings is an indentation 104 in the center of friction ridges 102. This indentation allows conduit 4 to be inserted when arms 94 are rotated backward flush against housing 90 (see FIG. 9A). Extension 134 is also added to increase the reach of wing 108. Without this extension, arms 94 would be too far apart for wings 108 to form a crevice tool. FIG. 11 shows a side view of the alternate nozzle in section. This design has the same angled passage as the five-function tool, but only has two ports. The elimination of the extra port is accomplished by redesigning the arms so that a suction conduit can be installed in port 120. Indentation 104 allow the rotation axis of arms 94 to be placed closer to each other. This reduces the length of extension 134 and flanges 114F and 114B. Indentation 104 also helps reduce the overall width of housing and thus makes a smaller nozzle. NOVEL FEATURES The invention has many novel features, the most notable being that it functions as five-tools-in-one. Even more amazing is that two of the functions (corner and edge tool configuration) were created by accident when making a three-function tool. The arm design allowed these two added function by simply adjusting the arms. This was all accomplished without any added parts compared to Fahlen's 2-function nozzle. The arm assembly itself is novel, because it allows so many tools to be incorporated into a single unit (Crevice, Edge, Corner, and Upholstery tools). The arm design requires only three parts: a Tool Housing, and a Left and Right Arm. By pivoting of the arms into different positions one can convert between functions. The open ended channel defined on each arm is also novel and without which a crevice tool could not be formed. Finally, the three-port tool housing design is novel. The ability to use the vacuum hose conduit to seal off unwanted ports is critical to the design. The double-inlet double-outlet three-port design, is both new and unusual. It allows two separate tool assemblies to receive air from two separate air ports, while only having a total of three ports. SUMMARY, RAMIFICATIONS, and SCOPE Although the above description of the invention contains many specifications, these should not be viewed as limiting the scope of the invention. Instead, the above description should be considered illustrations of some of the presently preferred embodiments of this invention. For example, the seal flanges on the tool housings, could be eliminated all together by redesigning the arms so that they mesh. Also, the length of the arms is a matter of preference, being easily made longer or shorter. Many other minor changes in the invention could be made, such as, changing the shape of the tool housing, the shape of the arms, the position and angle of the ports, the shape and length of the brush, the friction method on the arms, and etc. Furthermore, brush 44 and recess 42 need not be round, but could be made to whatever shape desired. Alternative ways to attach bristles 45 would include molding them directly into the housing, gluing them into recess 42, or etc. Likewise, stop 128 for the alternate nozzle, is not needed if port 120 was made longer. The arm designs may also be changed. Arms 94 on the alternate nozzle in FIG. 9B could easily be redesigned so that channel 110 is wider and deeper near its inner end (where attached to housing). Air channel 110 on each arm would then be much larger, and this added space would allow easy entry of a suction conduit into port 120. The arms would only need to be separated a small angle from the crevice tool position for suction conduit 4 to be inserted. This would eliminate the need for the arms to rotate passed and in-line (upholstery configuration) and thus make a more stable upholstery tool. Finally, the housings could also be changed. If made from a hard plastic, slots could be cut into the sealing flanges, which would lead to the peg holes. This would allow the arms to be snapped in place even though the housing does not have much resiliency. Or one could just replace the peg holes with dimples that receive a nipple formed on the arms. The arms would then be snapped into place. Thus, the scope of this invention should not be limited to the above examples, but should be determined from the following claims.

1a

This is a division of application Ser. No. 444,587, filed Dec. 1, 1989, now U.S. Pat. No. 5,019,153, which is a division of application Ser. No. 861,954, filed May 12, 1986, now U.S. Pat. No. 4,855,026. This invention relates to a new class of 2,6-substituted pyridinecarboxylic acid derivatives having a wide range of activity as herbicides. Pyridine derivatives have, for many years, been investigated for use in the biological sciences. For example, 2,6-bis-(trifluoromethyl)-4-pyridinols have been found useful as herbicides and fungicides as disclosed in U.S. Pat. No. 3,748,334. Such compounds are characterized by substitution in the 4-position by a hydroxyl radical. In addition to the hydroxyl radical, the pyridine nucleus may also be substituted with bromo, chloro or iodo radicals. Trifluoromethyl pyridine derivatives have also been disclosed in U.S. Pat. Nos. 2,516,402 and 3,705,170 wherein the nucleus is further substituted by halogens as well as numerous other substituents. Some of these compounds are also noted to be useful as herbicides. Also known because of their fungicidal activity are 4-substituted 2,6-dichloro-3,5-dicyanopyridines wherein the 4-position is substituted with alkyl, phenyl, naphthyl or pyridyl groups. Such compounds are disclosed in U.S. Pat. No. 3,284,293, while similar compounds are disclosed in U.S. Pat. No 3,629,270 wherein the 4-position is substituted with a heterocyclic group wherein the hetero atom is oxygen or sulfur. In EPO patent 44,262 there are disclosed 2,6-dialkyl-3-phenylcarbamyl-5-pyridinecarboxylates and -5-cyano-compounds useful as herbicides. There is no disclosure of the 2-haloalkyl radicals nor any substitution in the 4-position of the pyridine ring. The pyridine derivatives have also received attention in the search for new herbicides and have been reported in U.S. Pat. Nos. 1,944,412, 3,637,716, and 3,651,070. All of these patents disclose polyhalo derivatives of dicarboxypyridines. All have in common the direct substitution on a ring carbon by a halogen in the 3- and 5-positions while the 2- and 6-positions are occupied by carboxylate groups. The 4-position is open to substitution by a wide range of materials including halogens, hydroxy radicals, alkoxy, and carboxyl groups. Such compounds have found utilization as herbicides, bactericides, and fungicides. When the 4 position is occupied by a silver salt, U.S. Pat. No. 1,944,412 discloses that such compounds have been utilized in the production of X-ray pictures with intraveneous injection of such compounds. Pyridine dicarboxylate compounds useful as herbicides are described in European Patent publication 133,612 which corresponds to U.S. Pat. No. 4,692,184. These compounds have fluorinated methyl groups at the 2- and 6-positions and carboxylic acid derivative at the 3- and 5-positions. BRIEF DESCRIPTION OF THE INVENTION It is an object of this invention to provide herbicidal methods and compositions utilizing the novel pyridines of this invention. The compounds of this invention are useful as herbicides or intermediates which can be converted to herbicides and are represented by the generic formula ##STR5## wherein: Y is selected from O and S; R 1 and R 4 are independently selected from fluorinated methyl, chlorofluorinated methyl, and C 1 -C 4 alkyl, provided that not both R 1 and R 4 may be C 1 -C 4 alkyl; R 2 is selected from hydrogen, lower alkyl, haloalkyl, alkenyl, alkynyl, haloalkenyl, aryl, benzyl, and a cation; R 3 is selected from C 1 -C 5 alkyl, cycloalkyl, cycloalkylalkyl, hydroxy, alkoxy, alkylthio, dialkylamino, alkylamino, cycloalkylamino, cycloalkoxy, and cycloalkylthio; and X is selected from a) a halogen; ##STR6## where R 6 is selected from H, ##STR7## in which R 9 is C 1 -C 4 alkyl, R 11 is selected from H and C 1 -C 4 alkyl, R 12 is selected from R 1 and lower haloalkyl, where R 1 is C 1 -C 4 alkyl, R 13 a is hydrogen, alkyl, or haloalkyl; c) --N 3 ; d) ##STR8## in which R 8 is selected from H, alkyl and CF 3 and R 10 is selected from F, Cl, --OR 1 , --SR 1 , --NHR 1 , --N(R 1 ) 2 , phenyl, substituted phenyl, and --P(OR 1 ) 2 ; where R 1 is as defined above; e) --N═S═O; f) --NO 2 ; ##STR9## wherein R 1 is as defined above; ##STR10## wherein R 14 and R 15 are independently selected from hydrogen and alkyl; and k) --N═C═O The term "alkyl" means herein both straight and branched chain radicals which include, but are not limited to, ethyl, methyl, n-propyl, 1-ethylpropyl, 1-methylpropyl, n-butyl, 2,2-dimethylpropyl, pentyl, isobutyl, isopropyl. The term "cycloalkyl" is intended to mean saturated cyclic radicals such as cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, and cycloheptyl, as well as substituted cycloalkyl radicals. The term "lower alkyl" herein means an alkyl radical having 1 to 7 carbon atoms. The term "cycloalkylalkyl" is intended to mean alkyl radicals substituted with a C 3-6 cycloalkyl radical. The term "haloalkyl" is intended to mean alkyl radicals substituted with one or more halogen atoms. The terms "lower alkenyl" and "lower alkynyl" herein mean alkenyl and alkynyl groups having 3 to 7 carbon atoms. Examples of such alkenyl groups include 2-propenyl, 2-butenyl, 3-butenyl, 2-methyl-2-propenyl, and the like. Examples of such lower alkynyl groups include 2-propenyl, and so forth. The term "cation" means any cation derived from a base providing a salt. Typical cations include, but are not limited to, alkali metals such as sodium, potassium, and lithium, alkaline earth metals such as calcium, organic amines, and ammonium salts, sulfonium salts, phosphonium salts, and other salt complexes. The term "fluorinated methyl" means herein methyl radicals having one or more fluorine atoms attached thereto including radicals wherein all hydrogen atoms replaced by fluorine. The term "chlorofluorinated methyl" means herein a methyl radical having at least one hydrogen replaced by fluorine and at least one other hydrogen replaced by chlorine. DETAILED DESCRIPTION OF THE INVENTION The schemes shown below schematically depict a method whereby the pyridine monocarboxylate compounds of this invention may be prepared from compounds which are known in the art. Starting with a pyridinedicarboxylate compound such as those described in European Patent Publication No. 133,612, the dicarboxylic acid chloride is prepared by treating with a chlorinating agent such as PCl 5 or SOCl 2 . The or 5-amino-monocarboxylate is then prepared from the 3- or 5-chlorocarbonyl compound by treatment with NaN 3 followed by a Curtis rearrangement. The 3- or 5-amino compound so produced is then transformed into a 3- or 5-halogen substituted pyridinemonocarboxylate or a compound in which the atom linked to the pyridine ring at the 3- or 5-position is a nitrogen atom as shown in Schemes 2, 3 and 4. Reference to the Examples will provide greater detail about the steps shown in Schemes 1-4. ##STR11## Preparation of further compounds of this invention will become clear by reference to the scheme in conjunction with the following examples. As used throughout the specification, including the Examples, the following abbreviations have the following meanings: LDA--lithium diisopropylamide THF--tetrahydrofuran DME--dimethyl ether DBU--1,8 diazobicyclo-[5 4.0]-undec-7-ene DMF--N,N-dimethylformamide ETFAA--ethyl trifluoroacetoacetate MCPBA--m-chloroperbenzoic acid HPLC---high pressure liquid chromatography TLC--thin layer chromatography n-BuLi--n-Butyl lithium DMSO--dimethyl sulfoxide Pd/C--hydrogenation catalyst which is palladium deposited on finely-divided carbon TsCl--tosyl chloride. As used in the following Examples, the terms "workup as usual", or "normal workup", or equivalent language refer to the process of washing the organic extract with brine, drying by pouring through a cone of anhydrous sodium sulfate, and concentrating in vacuo. EXAMPLE 1 3-Pyridinecarboxylic acid, 5-amino-6-(difluoromethyl) -4-isobutyl-2-(trifluoromethyl)-,ethyl ester. Six grams (15.1 mmol) of product of Example 32 of European Patent Application No. 133,612 published Feb. 27, 1985, was added to 0.95 g of 89% potassium hydroxide (15.1 mmol) and 35 mL of ethanol and was stirred at room temperature for 1 day. The reaction mixture was poured into 135 mL of water, washed with ether (2×20 mL) and acidified with concentrated hydrochloric acid. The product was extracted into ether (2×50 mL), which was worked up as usual to afford 4.91 g (88%) of the desired mono-acid as an off-white solid suitable for further transformation. This was refluxed overnight with thionyl chloride (25 mL). The excess thionyl chloride was removed in vacuo and the resulting acid chloride was added dropwise to a rapidly-stirred slurry of 1.8 g of sodium azide in 15 mL of 4:1 acetone:water. This was stirred at room temperature for the weekend, then diluted with 75 mL of water and extracted with ether 3×20 mL . Workup as usual afforded 4.66 g (91% overall yield) of product as a tan solid. Recrystallization from cyclohexane gave analytically pure material, mp 68°-70° C. ______________________________________Elemental Analysis C H N______________________________________Calculated 49.41 5.04 8.23Found 49.23 4.97 8.26______________________________________ EXAMPLE 2 3-Pyridinecarboxylic acid, 5-amino-6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-, ethyl ester. A mixture of 35.0 g (0.103 mol) of product of Example 55 of European Patent Application No. 133,612 published Feb. 27, 1985, and 60 mL of thionyl chloride was refluxed overnight. The excess thionyl chloride was removed in vacuo, and the acid chloride was diluted with 10 mL of acetone and added to a slurry of 14.3g of NaN 3 25 ml of H 2 O and 90 ml of acetone. An exothermic reaction occurred with vigorous gas evolution. After the reaction mixture cooled to room temperature, 300 mL of water was added and the product was extracted into chloroform. Normal workup gave 30.9 g (96%) of product as a tan solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 92°-94° C. ______________________________________Elemental Analysis C H N______________________________________Calculated 46.16 4.20 8.97Found 46.08 4.23 8.94______________________________________ 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-(methoxycarbonyl)amino]-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. A mixture of 13.7g (0.037 mol) of ethyl 6-(difluoromethyl)-5-(chlorocarbonyl) -4-(2-methylpropyl)-2-(trifluoromethyl) -3-pyridinecarboxylate prepared by methods shown in European Patent Application No. 133,612 published Feb. 27, 1985, and 40 ml of thionyl chloride was stirred at reflux for 7 hours, then was concentrated in vacuo. The residue was kugelrohr distilled (130° C. at 1 torr) to give 13.4g (93%) of the corresponding acid chloride as a yellow oil. To a 0° C. solution of 5.0 g (0.013 mol) of this acid chloride in 50 mL of chloroform was added dropwise a solution of 1.03 g (0.013 mol) of pyridine and 14.5 mL 0.0149 mol) of 1.025 M hydrazoic acid in chloroform. After the addition was complete, the reaction mixture was stirred 30 min at room temperature, diluted with 20 mL of methanol and heated on a hot plate until gas evolution ceased. This was then poured into 100 mL of water and extracted with chloroform (3×40 mL). Normal workup afforded 5.03 g (97%) of product as a tan solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 109°-110° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.25 4.81 7.03Found 48.03 4.76 7.21______________________________________ EXAMPLE 4 3-Pyridinecarboxylic acid, 5-([Bis (1-methylethyl)amino]carbonylamino)-6-(difluoromethyl) -4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. A mixture of 13.7g (0.037 mol) of ethyl 6-(difluoromethyl)-5-(chlorocarbonyl)-4-(2-methylpropyl) -2-(trifluoromethyl)-3-pyridinecarboxylate prepared by methods shown in European Patent Application No. 133,612 published Feb. 27, 1985, and 40 ml of thionyl chloride was stirred at reflux for 7 hours, then was concentrated in vacuo. The residue was kugelrohr distilled (130° C. at 1 torr) to give 13.4g (93%) of the corresponding acid chloride as a yellow oil. A 0° C. solution of 5.0 g (0.013 mmol) of this acid chloride in 50 mL of chloroform was added dropwise to a solution of 1.03 g (0.013 mol) of pyridine and 14.5 mL (0.015 mol) of 1.025 M hydrazoic acid in chloroform. After the addition was complete, it was stirred at room temperature for 30 min. Then 20 mL of diisopropylamine was added causing an exothermic reaction to occur. The reaction was allowed to cool to room temperature and diluted with 100 mL of water. The product was extracted into chloroform (3×40 mL). Normal workup afforded 5.54 g 91 ) of product as a tan solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 137°-139° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 53.96 6.47 8.99Found 53.91 6.46 8.95______________________________________ EXAMPLE 5 3-Pyridinecarboxylic acid, 5-amino-6-(difluromethyl) -4-ethyl-2-(trifluoromethyl)-,methyl ester. A mixture of 45.0g (0.132 mol) of methyl 5-carboxy-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl) -3-pyridinecarboxylate prepared by methods shown in European Patent Application No. 133,612 published Feb. 27, 1985, 8.91g (0.135 mol) of 85% potassium hydroxide, 125 ml of methanol and 15 ml of water was stirred at room temperature for 24 hours. The reaction mixture was poured into water (500 ml), washed with chloroform (2×200 ml), and then was acidified with concentrated hydrochloric acid. Extraction with ethyl acetate (3×150 ml) followed by workup as usual afforded 38.2g (88%) of the corresponding carboxylic acid as a white solid. A solution of 38.2g (0.117 mol) of this acid and 50 mL of thionyl chloride was refluxed for 3 h. The excess thionyl chloride was removed in vacuo and the remaining acid chloride was dissolved in acetone (15 mL). This was added to a rapidly stirred slurry of 17.8 g (0.27 mol) of sodium azide, 30 mL of water and 100 mL of acetone, resulting in an exothermic reaction with vigorous gas evolution. After 2 h, the reaction mixture was diluted with 200 mL of water and extracted with chloroform (3×70 mL). Normal workup afforded 33.0 g (86%) of product as a tan solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 92°-93° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.30 3.72 9.39Found 44.59 3.83 9.16______________________________________ EXAMPLE 6 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(methoxycarbonyl]amino]-2-(trifluoromethyl) -,ethyl ester. A solution of 5.0 g (0.015 mol) of product of Example 28 of European Patent Application No. 133,612 published Feb. 27, 1985, and 15 mL of thionyl chloride was refluxed overnight. The excess thionyl chloride was then removed in vacuo and the resulting acid chloride was diluted with 25 mL of methylene chloride and cooled to 0° C. To this stirred solution was added dropwise a mixture of 1.16 g of pyridine and 16 mL of 1.0 M hydrazoic acid in chloroform. After the addition was complete, the reaction mixture was warmed to room temperature for 10 min. Then, 35 mL of methanol was added and the reaction mixture was warmed on a hot plate until gas evolution ceased. This was then diluted with 100 mL of water and extracted with chloroform (3×40 mL). Normal workup afforded 5.6 g (quantitative) of product as an off-white solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 84°-86° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.41 4.08 7.51Found 45.17 4.08 8.14______________________________________ EXAMPLE 7 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-(2-methylpropyl]-5-L(trifluoroaoetyl) amino]-2-itrifluoromethyl)-, ethyl ester. To a slurry of 1.08 g (0.027 mol) of 60% sodium hydride and 10 mL of anhydrous tetrahydrofuran was added a solution of 8.0 g (0.023 mol) of product of Example 1 in 10 mL of tetrahydrofuran. This was refluxed for 2 h, then stirred overnight at room temperature. To this was added 5.5 g (0.026 mol) of trifluoroacetic anhydride dropwise. This was stirred for 1 h then poured into 100 mL of 5% hydrochloric acid and extracted with chloroform (3×50 mL). Normal workup afforded 11.0 g of brown solid. Recrystallization from ethyl acetate/cyclohexane afforded 9.53 g (90%) of product as a white solid, mp 102°-104° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.05 3.70 6.42Found 44.45 3.76 6.44______________________________________ EXAMPLE 8 3-Pyridinecarboxylic acid, 5-chloro-6-(difluoromethyl) -4-isobutyl-6-itrifluoromethyl)-,ethyl ester. To a mixture of 2.96 g (0.022 mol) of cupric chloride, 2.26 g (0.018 mol) of t-butyl nitrite and 40 mL of acetonitrile is added dropwise to a solution of 5.0 g (0.015 mol) of product of Example 1 in 10 mL of acetonitrile. This was stirred overnight at room temperature, then poured into 100 mL of 2.5 M hydrochloric acid. The product was extracted into 3×50 mL of ether. Workup as usual afforded 5.26 g of dark brown oil. This was chromatographed on the Prep-500 using 2% ethyl acetate/cyclohexane as elution solvent. Fraction 1 afforded 2.14 g (41%) of product as a colorless oil material; n D 25 1.456 ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 46.75 4.20 3.89 9.86Found 46.82 4.24 3.86 9.90______________________________________ EXAMPLE 9 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-iodo-4-isobutyl-2-(trifluoromethyl)-, ethyl ester. To a 0° C. solution of 4.0 g (0.012mol) of product of Example 1, 2.16 g (0.012 mol) of 48% fluoroboric acid and 30 mL of acetonitrile was added 1.34 g (0.013 mol) of t-butyl nitrite. This was allowed to stir at 0° C. for 30 min, then it was added to a solution of 30 g potassium iodide in 150 mL of water. After stirring for 30 min, the reaction mixture was extracted with chloroform (4×40 mL). The chloroform extract was washed with 10% sodium thiosulfate (2×50 mL), brine (50 mL) and dried through a cone of sodium sulfate. Concentration in vacuo afforded 4.82 g of orange oil which was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. The first fraction contained 1.98 g (37%) of product as a colorless oil; n D 25 1.493. ______________________________________Elemental Analysis: C H N______________________________________Calculated 37.27 3.35 3.10Found 37.55 3.42 3.13______________________________________ The second fraction contained 1.65 g (31%) of product as a light yellow oil; n D 25 1.488. ______________________________________Elemental Analysis: C H N______________________________________Calculated 37.27 3.35 3.10Found 37.57 3.40 3.09______________________________________ EXAMPLE 10 3-Pyridinecarboxylic acid, 5-chloro-6-(difluoromethyl) -4-ethyl-6-(trifluoromethyl)-,ethyl ester. To a slurry of 2.55 g (0.019 mol) of cupric chloride, 2.48 g (0.024 mol) of t-butyl nitrite and 70 mL of anhydrous acetonitrile was added a solution of 5.0 g (0.016 mol) of product of Example 2 in 5 mL acetonitrile. This was stirred at room temperature for 2 h, diluted with 200 mL of 10% hydrochloric acid and extracted into chloroform (3×40 mL). Normal workup afforded an orange oil which was Kugelrohr distilled (120° C. @ 1.0 torr) to give 4.57 g (86%) of product as a colorless liquid. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 43.46 3.34 4.22 10.69Found 43.44 3.41 4.30 10.81______________________________________ EXAMPLE 11 3-Pyridinecarboxylic acid, 5-chloro-6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-,methyl ester. To a solution of 3.23 g (0.024 mol) of cupric chloride, 3.09 g (0.030 mol) of t-butyl nitrite and 65 mL of acetonitrile was added to a solution of 6.0 g of product of Example 5 in 10 mL of acetonitrile. After stirring at room temperature for 3 h, the reaction mixture was poured into 200 mL of 10% hydrochloric acid and extracted with chloroform (3×70 mL). Normal workup afforded 6.32 g of an orange oil which was chromatographed on the Prep-500 using 2% ethyl acetate/cyclohexane. Workup of the first fraction afforded 4.12 g 66%) of product as a white solid. Recrystallization from cyclohexane afforded analytically pure material, mp 62°-62° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 41.59 2.86 4.41 11.16Found 41.57 2.79 4.34 11.18______________________________________ EXAMPLE 12 3-Pyridinecarboxylic acid, 5-bromo-6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-,ethyl ester. To a solution of 5.09 g (0.023 mol) of cupric bromide, 2.94 g (0.029 mol) of t-butyl nitrite and 70 mL of anhydrous acetonitrile was added a solution of 6.0 g (0.019 mol) of product of Example 2 in 5 ml acetonitrile. This was stirred at room temperature for 2 h, then poured into 10% hydrochloric acid (200 mL) and extracted with chloroform (3×40 mL). Normal workup afforded 6.95 g of a light yellow oil. Kugelrohr distillation (125° C. @ 1.0 torr) gave 6.35 g (89%) of product as a white solid. Recrystallization from cyclohexane gave analytically pure material, mp 39°-41° C. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 38.32 2.95 3.72 21.25Found 38.47 2.99 3.77 21.40______________________________________ EXAMPLE 13 3-Pyridinecarboxylic acid,5-bromo-6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-,methyl ester. To a solution of 5.36 g (0.024 mol) of cupric bromide, 3.09 g (0.030 mol) of t-butyl nitrite and 6.5 mL of acetonitrile was added a solution of 6.0 g (0.020 mol) of product of Example 5 in 10 mL of acetonitrile. After stirring for 3 h at room temperature, the reaction mixture was added to 200 mL of 10% hydrochloric acid and extracted with chloroform. Normal workup afforded 7.05 g of brown oil which was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the first fraction afforded 4.83 g (68%) of product as a white solid. Recrystallization from cyclohexane afforded analytically pure material, mp 61°-62° C. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 36.49 2.51 3.87 22.07Found 36.56 2.55 3.86 22.16______________________________________ EXAMPLE 14 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-iodo-2-(trifluoromethyl)-,ethyl ester. To a 0° C. solution of 2.0 g (6.40 mmol) of product of Example 2, 1.18 g (6.40 mmol) of 48% fluoroboric acid and 10 mL of acetonitrile was added to 0.72 g of t-butyl nitrite. This solution was stirred at 0° C. for 15 min then was added to a rapidly stirred solution of 12 g of potassium iodide in 100 mL of water. This was stirred for 30 min, then was extracted with chloroform (3×40 mL). The combined chloroform extract was washed with 10% sodium thiosulfate (2×100 mL), brine (50 mL), and dried through a cone of sodium sulfate. Concentration in vacuo afforded an orange oil which was filtered through a short plug of silica gel (5% ethyl acetate/cyclohexane as eluant) to afford 2.10 g (78%) of product as a white solid. Recrystallization from cyclohexane afforded analytically pure material, mp 63°-65° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 34.06 2.62 3.31Found 34.32 2.68 3.30______________________________________ EXAMPLE 15 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-iodo-2-(trifluoromethyl)-,methyl ester. To a 0° C. solution of 6.25 g (0.021 mol) of product of Example 5, 3.84 g (0.021 mol) of 48% fluoroboric acid and 55 mL of acetonitrile was slowly added 2.38 g 0.023 mol) of t-butyl nitrite. This was stirred at 0° C. for 30 min, then added to a rapidly stirred solution of 55 g of potassium iodide in 200 mL of water. After 20 min, this was diluted with water 20 (200 mL) and extracted with chloroform (3×50 mL). This was washed with 10% sodium thiosulfate (2×50 mL), brine (100 mL) and dried through sodium sulfate. Concentration in vacuo afforded 7.80 g of brown oil, which was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the first fraction afforded 4.58 g (56%) of product as a white solid. Recrystallization from cyclohexane afforded analytically pure material, mp 62°-63° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 32.30 2.22 3.42Found 32.37 2.26 3.38______________________________________ EXAMPLE 16 3-Pyridinecarboxylic acid,5-amino-6-(difluoromethyl) -4-propyl-2-(trifluoromethyl)-,ethyl ester. To a stirred slurry of 41.3 g of sodium azide, 75 mL of water and 260 mL of acetone was slowly added a solution of 109 g (0.292 mol) of product of Example 47 of European Patent Application No. 133,612 published Feb. 27, 1985, in 30 mL of acetone. An exothermic reaction took place with vigorous gas evolution. After the reaction mixture cooled to room temperature, it was diluted with water (500 mL) and extracted into CHCl 3 (3×150mL). Normal workup afforded 94.8g (quantitative) of product as an offwhite solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 73°-75° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.86 4.63 8.59Found 47.79 4.66 8.59______________________________________ EXAMPLE 17 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-(ethoxymethylene)amino]-4-propyl-2-(trifluoromethyl)-, ethyl ester. A solution of 20.0 g (0.061 mol) of product of Example 16, 22.7 g (0.153 mol) of triethyl orthoformate and 300 mg of p-toluenesulfonic acid was heated at 110° C. with removal of ethanol by distillation. After 4 h, the excess orthoformate was removed in vacuo and the residue was Kugelrohr distilled (140° C. @ 1 torr) to afford 23.3 g (quantitative) of product as a colorless liquid; n D 25 1.462. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 50.18 5.01 7.29______________________________________ EXAMPLE 18 3-Pyridinecarboxylic acid, S-amino-4-ethyl -6-methyl-2-(trifluoromethyl)-,ethyl ester. A solution of 19.2 g (0.054 mol) of 3-t-butyl 5-ethyl 4-ethyl-2-methyl-6-(trifluoromethyl)-3,5-pyridinedicarboxylate prepared by methods shown in European Patent Application No. 133,612, and 40 mL of 97% formic acid was stirred overnight at 85° C. The reaction mixture was then concentrated in vacuo to give an orange oil which was diluted with 50 mL of thionyl chloride and refluxed for 3 h. The excess thionyl chloride was removed in vacuo and the residue was Kugelrohr distilled to give 13.4 g (78%) of the acid chloride. This was taken up in 5 mL of acetone and added to a stirred slurry of 7.5 g of sodium azide, 13 mL of water and 50 mL of acetone. An exothermic reaction occurred with vigouous gas evolution. After the reaction mixture cooled to room temperature, it was diluted with 200 mL of water and extracted with chloroform (3×75 mL). Normal workup afforded an oily solid which was chromatographed on silica gel using 20% ethyl acetate/cyclohexane to give 6.35 (55%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 107°-109° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 52.17 5.47 10.14Found 52.26 5.54 10.11______________________________________ EXAMPLE 19 3-Pyridinecarboxylic acid, 4-ethyl-6-methyl-5-nitro-2-(trifluoromethyl)-, ethyl ester. To a 55° C. slurry of 7.82 g of sodium perborate (0.051 mol) and 40 mL of glacial acetic acid was added a solution of 3.5 g (0.013 mol) of product of Example 18 in 15 mL of glacial acetic acid. The reaction mixture was maintained at 55° C. for 2 h, then was poured into 150 mL of water and extracted with chloroform (3×40 mL). Workup as usual afforded a dark oil which was Kugelrohr distilled (130° C. @ 1 torr) to give 1.57 g of product as a light yellow oil. The residue which did not distill was chromatographed on silica gel (1% EtOAc/cyclohexane) to afford an additional 1.00 g of product to give a total of 2.57 % (66%); n D 25 1.%65. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.07 4.28 9.15Found 47.01 4.29 9.23______________________________________ EXAMPLE 20 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-nitro-2-(trifluoromethyl),ethyl ester. To a solution of 4.0 g (0.013 mol) of product of Example 2 in 100 mL of concentrated sulfuric acid at 0° C. was carefully added 10 mL of 90% hydrogen peroxide. This was slowly warmed to room temperature over a 3-hour period and then stirred there overnight. The reaction mixture was diluted with ice (300 g) and extracted with chloroform. Normal workup gave a white solid which was chromatographed on silica gel using 1% ethyl acetate/cyclohexane. Workup of the first fraction gave 2.02 g (46%) of product as a white solid, mp 44°-46° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.12 3.24 8.19Found 42.28 3.25 8.15______________________________________ EXAMPLE 21 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-nitro-4-propyl-2-(trifluoromethyl)-,ethyl ester To a 0° C. solution of 15.0 g (0.046 mol) of product of Example 16 and 360 mL of concentrated sulfuric acid was carefully added 36 mL of 90% hydrogen peroxide. This was slowly warmed to room temperature over a 3-hour period and stirred there overnight. The reaction mixture was quenched with ice (300 g) and extracted into chloroform (3×100 mL). Workup as usual gave a white solid which was chromatographed on silica gel using 1% ethyl acetate/cyclohexane. Workup of the first fraction gave 9.35 g (57%) of product as a white solid, mp 63°-65° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 43.83 3.68 7.86Found 43.83 3.69 7.86______________________________________ EXAMPLE 22 3-Pyridinecarboxylic acid,2-(trifluoromethyl) -4-(2-methylpropyl]-5-nitro-6-(difluoromethyl)-, ethyl ester. To a 0° C. solution 6.0 g (0.018 mol) of product of Example 1 and 135 mL of concentrated sulfuric acid was carefully added 13.5 mL of 90% hydrogen peroxide, dropwise. This was slowly warmed to room temperature over a period of 3 h, then was stirred overnight. To this was added 200 g of ice chips and the resulting aqueous solution was extracted with chloroform (3×75 mL). Workup as usual gave a brown oil which was chromatographed on silica gel (1% ethyl acetate/cyclohexane). Workup gave 3.53 g (54%) of product as a white solid, mp 44°-46° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.41 4.08 7.57Found 45.47 4.03 7.75______________________________________ EXAMPLE 23 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-methyl-5-nitro-2-(trifluoromethyl)-, ethyl ester. To a 0° C. solution of 15.0 g (0.050 mol) of product of Example 71 and 360 mL of concentrated sulfuric acid was carefully added 36 mL of 90% hydrogen peroxide dropwise. This was slowly warmed to room temperature over a 3-hour period and allowed to stir there overnight. Then, 300 g of ice chips were added and the product was extracted into chloroform (3×75 mL). Workup as usual afforded an off-white solid which was Kugelrohr distilled (140° C. @ 1 torr) to give 11.8 g (72%) of product as a white solid, mp 93°-95° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.26 2.76 8.54Found 40.43 2.75 8.33______________________________________ EXAMPLE 24 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-nitro-2-(trifluoromethyl)-,methyl ester. To a 0° C. solution of 5.0 g (0.017 mol) of product of Example 5 and 120 mL of concentrated sulfuric acid was carefully added 12 mL of 90% hydrogen peroxide dropwise. This was stirred at 0° C. for 3 h, then slowly warmed to room temperature and stirred overnight. The reaction mixture was then diluted with 200 g of ice and extracted with chloroform. Workup as usual gave a white solid which was chromatographed on silica gel (1% ethyl acetate/cyclohexane). Workup of the first fraction afforded 2.73 g (50%) of product as a white solid, mp 65°-67° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.26 2.76 8.54Found 40.30 2.76 8.54______________________________________ EXAMPLE 25 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(trifluoroacetyl)amino-2-(trifluoromethyl)-, ethyl ester. A solution a 4.0 g (0.16 mol) of product of Example 2, 35 mL of trifluoroacetic anhydride and 20 mL of methylene chloride was stirred at room temperature for 3 h. The reaction mixture was then concentrated in vacuo (50° C. @ 20 torr) affording 6.19 g (95%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 98°-100° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 41.19 2.96 6.86Found 41.49 3.09 6.95______________________________________ EXAMPLE 26 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-methyl-5-(trifluoroacetyl)amino]-2-(trifluoromethyl)-, ethyl ester. A solution of 7.44 g (0.025 mol) of product of Example 71, 20 g of trifluoroacetic anhydride and 20 mL of chloroform was stirred at room temperature for 2 h. The reaction mixture was concentrated in vacuo to afford a white solid which was recrystallized from ethyl acetate/cyclohexane to give 8.5 g (90%) of product, mp 112°-114° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 39.61 2.56 7.14Found 39.55 2.58 7.11______________________________________ EXAMPLE 27 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(pentafluoropropionyl)amino]-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g 0.0128 mol) of product of Example 71, 15 mL of dichloromethane and 5.0 g (0.16 mol) of pentafluoropropionic anhydride was stirred at room temperature for 1 day. The reaction mixture was then concentrated in vacuo and Kugelrohr distilled (150° C. @ 5 torr) to give 4.8 g (82%) of product as a white solid, mp 113°-115° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 39.32 2.64 6.11Found 39.72 2.68 6.17______________________________________ EXAMPLE 28 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(pentafluoropropionyl)amino]-2-(trifluoromethyl)-, ethyl ester. A solution of 3.0 g (0.010 mol) of product of Example 5, 9 mL of pentafluoropropionic anhydride and 14 mL of chloroform was stirred at room temperature for 3 h. The reaction mixture was concentrated in vacuo affording a white solid. Recrystallization from ethyl acetate/cyclohexane gave 4.07 g (92%) of product as a white solid, mp 96°-98° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 37.85 2.27 6.31Found 38.10 2.41 6.50______________________________________ EXAMPLE 29 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-(formylamino)-4-methyl-2-itrifluoromethyl) -,ethyl ester. To 43.2 g (0.42 mol) of acetic anhydride at 0° C. was added 24.4 g (0.53 mol) of formic acid. This was warmed to room temperature, then heated at 50° C. for 15 min. This was then immediately cooled to 0° C. and 4.68 g 0.016 mol) of product of Example 71 was added. After stirring at room temperature for 40 min, the reaction mixture was concentrated in vacuo and the resulting solid was recrystallized from ethyl acetate to give 3.51 g (67%) of product as a white solid, mp 151°-152° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.18 3.40 8.59Found 44.11 3.43 8.57______________________________________ EXAMPLE 30 3-Pyridinecarboxylic acid, 5-[(α-chloroacetyl) amino-6-(difluoromethyl]-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.0128 mol) of product of Example 2, 1.50 g (0.013 mol) of chloroacetyl chloride and 10 mL of acetonitrile was stirred overnight at room temperature. A small amount of starting material remained, as determined by gas chromatography, so another 75 mg of chloroacetyl chloride was added and the reaction was stirred another 4 h. Concentration of the reaction mixture in vacuo gave 5.10 g (quantitative) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 104°-106° C. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 43.26 3.63 7.21 9.12Found 43.40 3.67 7.26 9.10______________________________________ EXAMPLE 31 3-Pyridinecarboxylic acid, 5-[(α,α-dichloropropionyl)amino]-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.0128 mol) of product of Example 2, 2.42 g (0.015 mol) of 2,2-dichloropropionyl chloride, 1.18 g (0.015 mol) of pyridine and 10 mL of acetonitrile was refluxed for 24 h. The reaction mixture was then poured into 50 mL of 1M hydrochloric acid and extracted with chloroform. Normal workup afforded a dark solid which was Kugelrohr distilled (160° C. @ 1 torr) to give 4.52 g (81%) of product as an off-white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 145°-146° C. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 41.21 3.46 6.41 16.22Found 41.26 3.46 6.37 16.15______________________________________ EXAMPLE 32 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(ethoxymethylene)amino]-4-methyl-2-(trifluoromethyl)-, ethyl ester. A solution of 5.0 g (0.0168 mol) of product of Example 71, 7.0 g of triethyl orthoformate and 100 mg of p-toluenesulfonic acid was heated at 110° C. with removal of ethanol by distillation. After 3 h, the reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (140° C. @ 1 torr) to afford 5.10 g (86%) of product as a colorless liquid; n D 25 1.46S. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.46 4.27 7.91Found 47.47 4.29 7.89______________________________________ EXAMPLE 33 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(ethoxymethylene)amino]-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.013 mol) of product of Example 2, 5.7 g (0.038 mol) of triethyl orthoformate and 70 mg of p-toluenesulfonic acid was stirred at 100° C. for 2 h with removal of the ethanol formed by distillation. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 3.86 g (82%) of product as a colorless oil; n D 25 . ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.92 4.65 7.61Found 48.78 4.62 7.51______________________________________ EXAMPLE 34 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(methoxymethylene)amino]-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.013 mol) of product of Example 2, 4.0 g (0.038 mol) of trimethyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 100° C. for 2 h, removing the methanol formed by distillation. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to afford 3.90 g (86%) of product a colorless oil; n D 25 1.463. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.46 4.27 7.91Found 47.67 4.36 7.86______________________________________ EXAMPLE 35 3-Pyridinecarboxylic acid, 6-(difluoromethyl)-5-[(ethoxymethylene) amino]-4-(2-methylpropyl) -2-(trifluoromethyl)-,ethyl ester. A solution of 3.75 g (0.011 mol) of product of Example 1, 4.90 (0.033 mol) of triethyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 100° C. for 2 h, removing the ethanol which formed by distillation. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 3.83 g (88%) of product as a colorless liquid; n D 25 1.464. ______________________________________Elemental Analysis: C H N______________________________________Calculated 51.52 5.34 7.07Found 51.80 5.48 7.03______________________________________ EXAMPLE 36 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(methoxymethylene)amino]-4-methyl-2-{trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.013 mol) of product of Example 71, 4.2 g (0.040 mol) of trimethyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 100° C. for 2 h, removing the methanol which formed by distillation. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 4.01 g (88%) of product as a light yellow oil; n D 25 1.463. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.89 3.85 8.23Found 45.89 3.94 8.03______________________________________ EXAMPLE 37 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-(methoxymethylene)amino]-2-(trifluoromethyl)-, methyl ester. A solution of 3.50 g (0.012 mol) of product of Example 5, 3.82 g (0.036 mol) of trimethyl orthoformate and 30 mg of p-toluenesulfonic acid was stirred at reflux for 2 h, then concentrated in vacuo. The residue was Kugelrohr distilled (145° C. @ 1 torr) to give 3.47 g (84%) of product as a colorless oil which slowly solidified, mp 29°-30° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.89 3.85 8.23Found 46.04 3.82 8.11______________________________________ EXAMPLE 38 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(methoxymethylene)amino]-4-propyl-2-(trifluoromethyl)-, ethyl ester. A solution of 3.0 g (0.0092 mol) of product of Example 16, 10 mL of trimethyl orthoformate and 70 mg of p-toluenesulfonic acid was stirred at 100° C. for 2 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (135° C. ° C. @ 1 torr to give 3.13 g (92%) of product as a colorless oil; n D 25 1.465. ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.92 4.65 7.61Found 48.66 4.57 7.33______________________________________ EXAMPLE 39 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(methoxymethylene)amino-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. A solution of 4.10g (0.012 mol) of product of Example 1, 7 mL of trimethyl orthoformate and 70 mg of p-toluenesulfonic acid was stirred overnight at 100° C. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr to give 4.07 g (89%) of product as a colorless oil; n D 25 1.457. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 50.16 5.19 7.01______________________________________ EXAMPLE 40 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(methoxymethylene)amino]-2-(trifluoromethyl)-, methyl ester. A solution of 4.0 g (0.013 mol) of product of Example 1, 10 mL of triethyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 100° C. for 3 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. ° C. @ 1 torr) to give 4.18 g (88%) of product as a colorless oil; n D 25 1.463. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.46 4.27 7.91Found 47.41 4.29 7.80______________________________________ EXAMPLE 41 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(2-methylpropoxy]methylene]amino}-4-propyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (.012 mol) of product of Example 16, 10 mL of tri-i-butyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 110° C. for 16 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. ° C. @ 1 torr) to afford 4.6 % (81%) of product as a colorless oil; n D 25 1.503. ______________________________________Elemental Analysis: C H N______________________________________Calculated 52.68 5.65 6.83Found 52.65 5.69 6.82______________________________________ EXAMPLE 42 3-Pyridinecarboxylic acid, 5-[(n-butoxymethylene)amino]-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A solution of 8.7 g of tri-n-butyl orthoformate, 4.0 g (0.013 mol) of product of Example 2 and 70 mg of p-toluenesulfonic acid was heated at 110° C. for 18 h. The reaction was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. ° C. 1 torr) to give a yellow oil. Chromatography on silica gel (2% ethyl acetate/cyclohexane) afforded 1.98 g (39%) of product as a colorless oil; n D 25 1.500. ______________________________________Elemental Analysis: C H N______________________________________Calculated 51.52 5.34 7.07Found 51.76 5.42 7.00______________________________________ EXAMPLE 43 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[[n-propoxymethylene)amino]-2-(trifluoromethyl)-,ethyl ester. A solution of 5.0 g (0.016 mol) of product of Example 2, 10 mL of tri-n-propyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 110° C. for 1 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (140° C. ° C. @ 1 torr) to give 4.25 g (69%) of product as a light yellow oil; n D 25 1 461. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 50.24 5.02 7.30______________________________________ EXAMPLE 44 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(2-methylpropoxy)methylene]amino}-2-(trifluoromethyl)-,ethyl ester. A solution of 4.0 g (0.013 mol) of product of Example 2, 10 mL of triisobutyl orthoformate and 70 mg of p-toluenesulfonic acid was heated to 110° C. for 18 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (140° C. ° C. @ 1 torr) to afford 3.8 g (75%) of product as a light yellow oil, which slowly crystallized, mp 34°-34° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 51.51 5.34 7.07Found 51.37 5.35 7.01______________________________________ EXAMPLE 45 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(N,N-dimethylamino)methylene]amino}-4-methyl-2-(trifluoromethyl)-, ethyl ester. A slurry of 5.0 g (0.168 mol) of product of Example 71, 4.0 g (0.34 mol) of dimethylformamide dimethylacetal and 100 mg of p-toluenesulfonic acid was heated at reflux for 1 h. The reaction mixture was concentrated in vacuo and Kugelrohr distilled (150° C. ° C. @ 1 torr) to give 5.20 g (88%) of product as a white solid, mp 70°-71° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.50 4.57 11.89Found 47.61 4.43 11.64______________________________________ EXAMPLE 46 3-Pyridinecarboxylic acid, 5-[(1-chloro-2,2,2-trifluoroethylidene) amino]-6-(difluoromethyl)-4-methyl-2-itrifluoromethyl)-, ethyl ester. A mixture of 4.0 g (0.010 mol) of product of Example 26 and 2.11 g (0.010 mol) of phosphorous pentachloride was heated to 140° C. and stirred there for 16 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (130° C.° C. @ 1 torr) to give 3.24 g of product as a colorless oil; n D 25 1.435. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 37.84 2.20 6.79 8.59Found 38.15 2.26 6.82 8.63______________________________________ EXAMPLE 47 3-Pyridinecarboxylic acid, 5-(1-chloro-2,2,2-trifluoroethylidene) amino-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A mixture of 33.5 g (0.082 mol) of product of Example 25 and 17.08 g (0.082 mol) of phosphorous pentachloride was heated at 140° C. for 18 h. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 31.7 g (91%) of product as a colorless oil; n D 25 1.436 ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 39.41 2.60 6.57 8.31Found 39.81 2.65 6.59 8.35______________________________________ EXAMPLE 48 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(1-ethoxy-2,2,2-trifluoroethylidene)amino]-4-ethyl-2-(trifluoromethyl)-, ethyl ester. To an ethanolic sodium ethoxide solution, prepared from 0.25 g (0.011 mol) of sodium metal and 5 mL of absolute ethanol, was added a solution of 4.0 g (0.0094 mol) of product of Example 47 in 5 mL of ethanol. A white precipitate formed immediately. After stirring for 15 min the reaction mixture was poured into water and extracted with chloroform. Workup gave a light yellow oil which was Kugelrohr distilled (130° C. ° C. @ 1 torr) to give 3.67 (89%) of product as a colorless oil; n D 25 1.440. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.05 3.70 6.42Found 44.46 3.76 6.48______________________________________ EXAMPLE 49 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(1-methoxy-2,2,-2-trifluoroethylidine)amino]-2-(trifluoromethyl)-,ethyl ester. To a methanolic sodium methoxide solution, prepared from 0.23 g (0.010 mol) of sodium metal and 4 mL of methanol was added a solution of 4.0 g (0.0094 mol) of product of Example 47 in 5 mL of methanol. A white precipitate formed immediately. After 15 min, the reaction mixture was poured into water and extracted with chloroform. Workup as usual gave a yellow oil which was Kugelrohr distilled (130° C. @ 1 torr) to give 3.63 g (91%) of product as a colorless oil which slowly solidified, mp 49°-51° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.67 3.34 6.63Found 43.03 3.39 6.65______________________________________ EXAMPLE 50 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[1-(ethylthio)-2,2,2-trifluoroethylidine]amino}-2-(trifluoromethyl)-,ethyl ester. To a slurry of 0.38 g (0.0094 mol) of 60% sodium hydride in 10 mL of anhydrous tetrahydrofuran under a nitrogen atmosphere was added 0.59 g (0.0094 mol) of ethanethiol. After gas evolution ceased, a solution of 4.0 g (0.0094 mol) of product of Example 47, 5 mL of tetrahydrofuran was added dropwise. After 15 min, the reaction mixture was poured into water and extracted with chloroform. Workup as usual gave a yellow oil which was Kugelrohr distilled (135° C. @ 1 torr) to give 3.87 g (91%) of product as a colorless liquid; n D 25 1.464. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 42.48 3.57 6.19 7.09Found 42.86 3.64 6.24 7.24______________________________________ EXAMPLE 51 3-Pyridinecarboxylic acid,5-{[1-(diethoxyphosphinyl)-2,2,2-trifluoroethylidene]amino}-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A mixture of 2.5 g (0.0059 mol) of product of Example 47 and 0.98 g of triethylphosphite was heated at 160° C. for 30 min. The reaction mixture was then cooled to room temperature where solidification occurred. Trituration of this solid with cyclohexane gave 3.03 g (quantitative) of product as a light yellow solid, mp 73°-75° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.92 4.01 5.30Found 40.72 4.00 5.19______________________________________ EXAMPLE 52 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-5-[5-(trifluoromethyl) -1H-tetrazol-1-yl]-,ethyl ester. To a solution of 4.0 g (0.0094 mol) of product of Example 47 and 0 mL of tetrahydrofuran was added 0 65 g (0.01 mol) of sodium azide. This was stirred at room temperature and 4 mL of water was added. The reaction mixture became warm immediately. After 5 min, the reaction mixture was diluted with water (25 mL) and extracted with chloroform (3×20 mL). Workup as usual afforded a thick oil which was Kugelrohr distilled (150° C. ° C. @ torr) to give 3.83 g (94%) of product as a light yellow oil; n D 25 1.444. ______________________________________Elemental Analysis: C H N______________________________________Calculated 38.81 2.56 16.16Found 39.12 2.68 15.92______________________________________ EXAMPLE 53 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-5-{[1-(trifluoromethyl)ethylidene]amino}-,ethyl ester. To a solution of 2.3 g (0.0054 mol) of product of Example 47 in 5 mL of anhydrous tetrahydrofuran at 0° C. under a dry nitrogen atmosphere was added dropwise 1.7 mL (0.0054 mol) of 3.2 M methyl magnesium bromide in ether. This was stirred at 0° C. for 30 min, then was poured into 10 mL of saturated ammonium chloride. The reaction mixture was suction filtered and the filtrate was extracted with ether (3×25 mL). Workup as usual gave an oil which was chromatographed on silica gel using 5% ethyl acetate/cyclohexane. Workup of the first fraction afforded 1.0 g (46%) of product as a colorless oil; n D 25 1.500. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.35 3.47 6.89Found 43.35 3.40 6.70______________________________________ EXAMPLE 54 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-isocyanato-2-(trifluoromethyl)-, ethyl ester. The product of Example 46 (50.4g, 0.14 mol) of European Patent Application No. 133,612 published Feb. 27, 1985, was added to 17.3 g of azidotrimethyl silane (0.15 mol) and 100 mL of carbon tetrachloride and heated at reflux until gas evolution ceased (˜4 h). The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (140° C. @ 1 torr) to give 35.2 g (74%) of product as a light yellow oil; n D 25 1.457. ______________________________________Elemental Analysis: C H N______________________________________Calculated 46.16 3.28 8.28Found 45.88 3.40 8.03______________________________________ EXAMPLE 55 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-isocyanato-2-(trifluoromethyl)-, methyl ester. Methyl 5-chlorocarbonyl-6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-3-pyridinecarboxylate (84.1 g, 0.243 mol) was added to 150 mL of carbon tetrachloride and 30 g (0.26 mol) of azidotrimethyl silane and stirred overnight at 55° C. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled to give 57.3 g (72%) of product as a white solid, mp 55°-57° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.46 2.80 8.64Found 44.32 2.94 8.77______________________________________ EXAMPLE 56 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-isocyanato-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. Ethyl 5-chlorocarbonyl-4-(2-methylpropyl) -2-(trifluoromethyl)-3-pyridinecarboxylate (64.1 g, 0.165 mol) was added to 21.06 (0.182 mol) of azidotrimethyl silane and 120 mL of carbon tetrachloride and heated at reflux for 4h, at which time, gas evolution ceased. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (100° C. @ 1 torr to give 29.4 g (65%) of product as a light yellow oil; n D 25 1.455. ______________________________________Elemental Analysis: C H N______________________________________Calculated 49.19 4.13 7.65Found 48.95 4.02 7.77______________________________________ EXAMPLE 57 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(ethylthio]carbonyl]amino}-2-(trifluoromethyl)-, ethyl ester. To a solution of 4.5 g (0.013 mol) of product of Example 54 and 20 mL of methylene chloride was added 15 mL of ethanethiol. To this was added 30 mg of potassium t-butoxide causing an exotherm. The reaction mixture was allowed to stir overnight then was concentrated in vacuo affording a light yellow solid. Recrystallization from ethyl acetate/cyclohexane gave 4.63 g (90%) of product as a white solid, mp 124°-126° C. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 45.00 4.28 7.00 8.01Found 44.73 4.14 6.80 7.83______________________________________ EXAMPLE 58 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(ethylthio)carbonyl]amino}-2-(trifluoromethyl)-,methyl ester. To a slurry of 0.49 g (0.012 mol) of 60% sodium hydride in 10 mL of anhydrous tetrahydrofuran was added a solution of 4.0 g (0.012 mol) of product of Example 55 in 25 mL of anhydrous tetrahydrofuran. This was stirred at room temperature for 1 h then 50 mL of water was added and the product was extracted into ethyl acetate (3×25 mL). Workup as usual gave 3.95 g (83%) of product as a white solid, mp 143°-145° C. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 43.52 3.91 7.25 8.30Found 43.42 3.97 7.21 8.38______________________________________ EXAMPLE 59 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(methylthio)carbonyl]amino}-2-(trifluoromethyl)-,methyl ester. A solution of 15.0 g (0.046 mol) of product of Example 55 and 50 mL of tetrahydrofuran was cooled to 0° C. and 10 g of methanethiol was added. To this mixture was added 100 mg of potassium t-butoxide. The reaction mixture was slowly warmed to room temperature and stirred overnight. The reaction mixture was concentrated in vacuo and the residue taken up in chloroform (100 mL). Workup as usual afforded 15.21 % (89%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 134°-135° C. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 41.94 3.52 7.52 8.61Found 42.01 3.53 7.57 8.57______________________________________ EXAMPLE 60 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(ethylthio)carbonyl]amino}-4-(2-methylpropyl) -2-(trifluoromethyl)-,ethyl ester. To a solution of 3.50 g (0.0095 mol) of product of Example 56, 0.93 g (0.015 mol) of ethanethiol and 20 mL of tetrahydrofuran was added 15 mg of potassium t-butoxide. This was stirred for 2 h at room temperature, then was concentrated in vacuo. This solid was dissolved in 75 mL of chloroform and worked up as usual to give 3.54 g (86%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 113°-114° C. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 47.66 4.94 6.54 7.48Found 47.65 4.96 6.52 7.56______________________________________ EXAMPLE 61 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(ethoxycarbonyl)amino]-4-ethyl-2-(trifluoro- methyl)-, methyl ester. A solution of 4.1 g (0.013 mol) of product of Example 55, 25 mL of chloroform and 25 mL of ethanol was stirred at reflux for 15 min. The reaction mixture was concentrated in vacuo to give 4.53 g (97%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 100°-101° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.41 4.08 7.75Found 45.31 4.11 7.63______________________________________ EXAMPLE 62 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(1-methylethoxy)carbonyl]amino}-2-(trifluoromethyl)-,methyl ester. A solution of 4.0 g (.012 mol) of product of Example 55, 25 mL of chloroform and 25 mL of 2-propanol was refluxed for 15 min. The reaction mixture was concentrated in vacuo to give 4.63 g (85%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 130°-132° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 46.88 4.46 7.29Found 46.67 4.47 7.37______________________________________ EXAMPLE 63 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(1-methylethylthio)carbonyl]amino}-2-(trifluoromethyl)-,methyl ester. To a solution of 4.0 g (0.012 mol) of product of Example 55, 5.0 g (0.066 mol) of 2-propanethiol and 20 mL of tetrahydrofuran was added 20 mg of potassium t-butoxide. The reaction mixture was stirred at room temperature for 2 hours then concentrated in vacuo to give a white solid. Recrystallization from ethyl acetate/cyclohexane afforded 4.37 (89%) of product as a white solid, mp 139°-140° C. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 45.00 4.28 7.00 8.01Found 45.04 4.30 7.00 8.06______________________________________ EXAMPLE 64 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-({[(1,1-dimethylethyl)thio]carbonylamino)-4-ethyl-2-(trifluoromethyl)-, methyl ester. A solution of 3.60 g (0.011 mol) of product of Example 55, 20 mL of chloroform and 20 mL of t-butanol was stirred at reflux for 15 min. The reaction mixture was concentrated in vacuo and the resulting solid was recrystallized from ethyl acetate/cyclohexane to give 4.01 g (91%) of product as a white solid, mp 99°-100° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.25 4.81 7.03Found 48.31 4.93 7.00______________________________________ EXAMPLE 65 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(methoxycarbonyl)amino]-2-(trifluoromethyl)-, methyl ester. A solution of 3.0 g (0.0093 mol) of product of Example 55, 20 mL of chloroform and 20 mL of methanol was stirred at reflux for 15 min, then concentrated in vacuo. The resulting solid was recrystallized from ethyl acetate/cyclohexane to give 3.08 g (93%) of product as a white solid, mp 111°-113° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 43.83 3.68 7.86Found 44.21 3.75 8.12______________________________________ EXAMPLE 66 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(dimethylamino)carbonyl]amino}-4-ethyl-2-(trifluoromethyl)-, methyl ester. To a solution of 3.0 g (0.0093 mol) of product of Example 55, 20 mL of dioxane was added 10 mL of 26% aqueous dimethylamine. This was stirred at 60° C. for 10 min, then was poured into 100 mL of water and extracted with chloroform (3×40 mL . Workup as usual afforded 3.06 g (89%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 177°-178° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.53 4.37 11.38Found 45.64 4.41 11.29______________________________________ EXAMPLE 67 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(N-methylamino)carbonyl]amino}-2-(trifluoromethyl)-, methyl ester. To a solution of 3.57 g (0.011 mol) of product of Example 55 and 20 mL of dioxane was added 7 mL of 40% aqueous methylamine. A white preciptiate formed immediately. This was stirred at 50° C. for 10 min, cooled to room temperature, and suction filtered. Air drying afforded 3.56 g (91%) of product as a white solid, mp 202°-203° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 43.95 3.97 11.83Found 43.82 4.02 11.78______________________________________ EXAMPLE 68 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-(4,5-dihydro-5-oxo-1H-tetrazol-1-yl)-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.012 mol) of product of Example 54 and 2.72 g 0.024 mol) of azidotrimethyl silane was refluxed for 1.5 days then was concentrated in vacuo. The reaction mixture slowly solidified over a period of 3 days. Trituration with ethyl acetate/cyclohexane gave 2.20 g (49%) of product as a white solid, mp 139°-141° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.95 3.17 18.37Found 40.88 3.21 18.33______________________________________ EXAMPLE 69 3-Pyridinecarboxylic acid, 5-{[(2-chloroethoxy)carbonyl]amino]-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.12 mol) of product of Example 54, 9 mL of chloroform and 9 mL of 2-chloroethanol was heated at reflux for 1.5 days. The reaction mixture was concentrated in vacuo and the residue slowly solidified over 3 days. Trituration with ethyl acetate/cyclohexane gave 3.27 g (66%) of product as a white solid, mp 102°-103° C. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 43.02 3.85 6.69 8.47Found 43.21 3.87 6.68 8.50______________________________________ EXAMPLE 70 3-Pyridinecarboxylic acid,5-{[(diethoxyphosphinyl)carbonyl]amino}-6-(difluoromethyl)-4-ethyl-2-(trifluoromethyl)-, methyl ester. To a solution of 4.0 g (0.012 mol) of product of Example 55 and 3 drops of triethylamine in 20 mL of toluene was added 1.70 g of diethyl phosphite. This was heated at 80° C. for 1.5 day, then was concentrated in vacuo. The residue was dissolved in chloroform, washed with water 20 mL , 1 M hydrochloric acid (20 mL ) and brine (20 mL). Workup as usual afforded 5.1 g (90%) of product as a white solid, mp 91°-94° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 41.57 4.36 6.06Found 41.24 4.28 6.29______________________________________ EXAMPLE 71 3-Pyridinecarboxylic acid,5-amino-6-(difluoromethyl) -4-methyl-2-itrifluoromethyl)-,ethyl ester. To a slurry of 50 g of sodium azide, 90 mL of water and 315 mL of acetone was added 0.474 mol of ethyl 5-chlorocarbonyl-6-(difluoromethyl)-4-methyl-2-(trifluoromethyl)-3-pyridinecarboxylate in 35 mL of acetone with rapid stirring. An exothermic reaction resulted with vigorous gas evolution. After the reaction mixture cooled to room temperature, it was diluted with 200 mL of water and extracted with chloroform. Normal workup afforded 86.3 g (82%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane afforded analytically pure material, mp 71°-72° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.30 3.72 9.39Found 44.30 3.73 9.40______________________________________ EXAMPLE 72 3-Pyridinecarboxylic acid,5-amino-6-(difluoromethyl) -4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. To a rapidly-stirred solution of 21 g of sodium azide, 35 mL of water and 140 mL of acetone was added a solution of 0.096 mol of product of Example 44 of European Patent Application No. 133,612 published Feb. 27, 1985, in 20 mL of acetone. An exothermic reaction followed with gas evolution. After the reaction mixture cooled to room temperature, it was diluted with water (300 mL) and extracted with chloroform (3×100 mL). Normal workup afforded 28.4 g (91%) of product as a tan solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 56°-58° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.86 4.63 8.59Found 47.92 4.68 8.58______________________________________ EXAMPLE 73 3-Pyridinecarboxylic acid, 5-chloro-6-(difluoromethyl) -4-methyl-2-(trifluoromethyl)-,ethyl ester. To a solution of 3.76 g (0.028 mol) of cupric chloride, 3.61 g (0.035 mol) of t-butyl nitrite and 80 mL of acetonitrile was added a solution of 7.0g (0.023 mol) of product of Example 71 in 7 mL of acetonitrile. This was stirred at room temperature for 90 min, then poured into 200 mL of 1 M hydrochloric acid and extracted with chloroform. Normal workup afforded an orange oil which was filtered through a short silica gel column with 2% ethyl acetate/cyclohexane. Concentration in vacuo afforded 5.92 g (81%) of product as a colorless liquid; n D 25 1.452. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 41.59 2.86 4.41 11.16Found 41.60 2.87 4.39 11.15______________________________________ EXAMPLE 74 3-Pyridinecarboxylic acid, 5-bromo-6-(difluoromethyl) -4-methyl-2-(trifluoromethyl)-,ethyl ester. To a solution of 6.25 g (0.028 mol) of cupric bromide, 3.61 g (0.035 mol) of t-butyl nitrite and 80 mL of acetonitrile was added a solution of 7.0 g (0.023 mol) of product of Example 71 in 7 mL of acetonitrile. This was stirred at room temperature for 1.5 h, then poured into 200 mL of 10% hydrochloric acid and extracted with chloroform (3×50 mL). Normal workup gave a yellow oil which was filtered through a short silica gel column (2% ethyl acetate/cyclohexane) to give 7.54 g (91%) of product as a colorless liquid; n D 25 1 470. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 36.49 2.51 3.87 22.07Found 36.47 2.53 3.86 21.99______________________________________ EXAMPLE 75 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-iodo-4-methyl-2-(trifluoromethyl)-,ethyl ester. To a 0° C. solution of 7.0 g (0.023 mol) of product of Example 71, 4.21 g 0.023 mol) of 48% fluoroboric acid and 60 mL of acetonitrile was added 2.61 g of t-butyl nitrite dropwise. This was stirred at 0° C. for 1 h, then added to a rapidly stirred solution of 60 g of potassium iodide in 200 mL of water. After 15 min, the reaction mixture was diluted with 200 mL of water and extracted with chloroform (3×100 mL). The chloroform extract was washed with 10% sodium thiosulfate (2×50 mL , brine (50 mL) and dried through sodium sulfate. Concentration in vacuo afforded an orange oil which was filtered through a short plug of silica gel. The resulting oil was Kugelrohr distilled (150° C. @ 1 torr) to afford 1.73 g (18%) of product as a white solid, mp 41°-43° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 32.30 2.22 3.42Found 32.51 2.12 3.60______________________________________ EXAMPLE 76 3-Pyridinecarboxylic acid, 5-chloro-6-(difluoromethyl) -4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. To a mixture of 2.69 g (0.02 mol) of cupric chloride, 2.58 g (0.025 mol) of t-butyl nitrite and 40 mL of acetonitrile was added a solution of 5.44 g (0.017 mol) of product of Example 72 in 7 mL of acetonitrile. This was stirred at room temperature for 1.5 h, poured into 150 mL of 1 M hydrochloric acid and extracted into chloroform (3×50 mL). Normal workup gave 5.73 g of a brown oil which was passed through a short silica gel column with 2% ethyl acetate/cyclohexane. Kugelrohr distillation (140° C. @ 2 torr) of the resulting oil afforded 4.32 g (75%) of product as a colorless liquid; n D 25 1.457. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 45.17 3.79 4.05 10.26Found 45.31 3.81 4.06 10.28______________________________________ EXAMPLE 77 3-Pyridinecarboxylic acid, 5-bromo-6-(difluoromethyl) -4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. To a solution of 4.47 g (0.020 mol) of cupric bromide, 2.58 g (0.025 mol) of t-butyl nitrite and 40 mL of acetonitrile was added a solution of 5.49 g (0.17 mol) of product of Example 72 in 7 mL of acetonitrile. This was stirred at room temperature for 1.5 h, poured into 150 mL of 1 M hydrochloric acid and extracted with chloroform (3×75 mL). Normal workup afforded a brown oil which was filtered through a short silica gel column with 2% ethyl acetate/cyclohexane. Kugelrohr distillation (140° C. @ 2 torr) of the resulting oil afforded 5.13 g (78%) of product as a colorless liquid; n D 25 1.473. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 40.02 3.36 3.59 20.48Found 40.05 3.38 3.57 20.40______________________________________ EXAMPLE 78 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-iodo-4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. To a solution of 6.0 q 0.018 mol) of product of Example 72, 3.29 g 0.018 mol) of 48% fluoroboric acid and 45 mL of acetonitrile was added 2.04 g (0.02 mol) of t-butyl nitrite dropwise. This was stirred at 0° C. for 15 min, then was added to a rapidly stirred solution of 60 g of potassium iodide in 150 mL of water. The reaction mixture was stirred for 30 min, then was diluted with water (200 mL) and extracted with chloroform (3×50 mL). The chloroform extract was washed with 100 mL of 10% sodium thiosulfate, 100 mL of brine, and dried though sodium sulfate. Concentration in vacuo afforded a red-orange oil that was filtered through a short silica gel column with 2% ethyl acetate/cyclohexane. Kugelrohr distillation (160° C. @ 2 torr) of the resulting oil afforded 4.3 g (55%) of product as a light yellow oil; n D 25 1.498. ______________________________________Elemental Analysis: C H N I______________________________________Calculated 35.72 3.00 3.20 29.03Found 35.83 3.00 3.15 28.94______________________________________ EXAMPLE 79 3™Pyridinecarboxylic acid, 5-chloro-6-(difluoromethyl) -4-propyl-2-(trifluoromethyl)-,ethyl ester. To a slurry of 4.97 g (0.037 mol) of cupric chloride, 4.84 g (0.047 mol) of t-butyl nitrite and 80 mL of acetonitrile was added a solution of 10.0 g (0.031 mol) of product of Example 16 in 10 mL of acetonitrile. Gas evolution occurred immediately. After the reaction was stirred at room temperature for 90 min, it was poured into 250 mL of 1 M hydrocholoric acid and extracted with chloroform. Normal workup afforded 10.45 g of a brown oil which was filtered through a short silica gel column (2% ethyl acetate/cyclohexane) and Kugelrohr distilled 130° C. @ 2 torr) to afford 7.33 g (68%) of product as a colorless liquid; n D 25 1.454. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 45.17 3.79 4.05 10.26Found 45.19 3.81 4.02 10.34______________________________________ EXAMPLE 80 3-Pyridinecarboxylic acid, 5-bromo-6-(difluoromethyl) -4-propyl-2-(trifluoromethyl)-,ethyl ester. To a solution of 8.26 g (0.037 mol) of cupric bromide, 4.84 g (0.047 mol) of t-butyl nitrite and 80 mL of acetonitrile was added 10.0 g (0.031 mol) of product of Example 16 in 10 mL of acetonitrile, resulting in immediate gas evolution. After 90 min the reaction mixture was poured into 250 mL of 1M hydrochloric acid. Extraction with chloroform (3×75 mL) and workup as usual afforded 11.81 g of a brown oil. This material was filtered through a short silica gel column (2% ethyl acetate/cyclohexane), then Kugelrohr distilled (135° C. @ 1.5 torr) to afford 8.7 g (72%) of product as a colorless Oil; n D 25 1.467. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 40.02 3.36 3.59 20.48Found 40.14 3.38 3.58 20.58______________________________________ EXAMPLE 81 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-iodo-4-propyl-2-(trifluoromethyl)-,ethyl ester. To a 0° C. solution of 10.0 g 0.031 mol) of product of Example 16, 5.67 g of 48% fluoroboric acid 0.031 mol) and 55 mL of acetonitrile was added 3.50 g (0.034 mol) of t-butyl nitrite dropwise. After 20 min at 0° C., the reaction mixture was added to a rapidly-stirred solution of 80 g of potassium iodide in 175 mL of water. This was stirred for 45 min, diluted with 200 mL of water and extracted with chloroform (3×75 mL). The chloroform extract was washed with 10% sodium thiosulfate (2×50 mL), brine (100 mL) and dried through sodium sulfate. Normal workup afforded 12.8 g of an oily brown solid which was filtered through a short silica gel column with 2% ethyl acetate/cyclohexane. Kugelrohr distillation (140° C. at 1.5 torr) afforded 9.32g (69%) of product as a white solid, mp 45°-48° C. ______________________________________Elemental Analysis: C H N I______________________________________Calculated 35.72 3.00 3.20 29.03Found 35.77 3.00 3.17 28.96______________________________________ EXAMPLE 82 3-Pyridinecarboxylic acid, 5-chloro-4-ethyl-6-methyl-2-(trifluoromethyl)-, ethyl ester. To a stirred slurry of 2.92 g (0.022 mol) of cupric chloride, 2.80 g (0.027 mol) of t-butyl nitrite and 50 mL of acetonitrile was added a solution of 5.0 g (0.018 mol) of product of Example 18 in 10 mL of acetonitrile. This was stirred at room temperature for 2 h, then was poured into 150 mL of 1 M hydrochloric acid and extracted with chloroform (3×75 mL). Workup as usual afforded a brown oil that was Kugelrohr distilled (120° C. @ 1 torr to give 4.73 g (88%) of product as a yellow liquid; n D 25 1.%70. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 48.74 4.43 4.74 11.99Found 48.83 4.20 5.11 12.26______________________________________ EXAMPLE 83 3-Pyridinecarobxylic acid, 5-bromo-4-ethyl-6-methyl-2-(trifluoromethyl)-, ethyl ester. To a stirred solution of 4.85 g (0.022 mol) of cupric bromide, 2.80 g (0.027 mol) of t-butyl nitrite and 50 mL of acetonitrile was added a solution of 5.0 g (0.018 mol) of product of Example 18 in 10 mL of acetonitrile. This was stirred at room temperature for 2 h, then was diluted with 200 mL of 1M hydrochloric acid and extracted with chloroform (3×75 mL). Normal workup afforded an orange oil that was Kugelrohr distilled (120° C. @ 1 torr) to give 5.21 g (84%) of product as a light yellow oil; n D 25 1.484. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 42.37 3.85 4.12 23.49Found 42.43 3.88 4.11 23.41______________________________________ EXAMPLE 84 3-Pyridinecarboxylic acid, 4-ethyl-5-iodo-6-methyl-2-(trifluoromethyl)-, ethyl ester. To a 0° C. solution of 4.66 g (0.017 mol) of product of Example 18, 3.08 g of 48% fluoroboric acid and 35 mL of acetonitrile was added 1.91 g (0.019 mol) of t-butyl nitrite dropwise. This was stirred at 0° C. for 25 min, then was added to a rapidly stirred solution of 40 g of potassium iodide in 120 mL of water. After 30 min, 120 mL of water was added and the reaction mixture was extracted with chloroform (3×70 mL). The chloroform extracts were washed with 10% sodium thiosulfate (2×50 mL , brine (50 mL and dried through sodium sulfate. Workup as usual afforded an orange oil that was Kugelrohr distilled (120° C. @ 1 torr) to give 4.88 (75%) of product as a light yellow oil; n D 25 1.504. ______________________________________Elemental Analysis: C H N I______________________________________Calculated 37.23 3.38 3.62 32.78Found 37.35 3.42 3.55 32.50______________________________________ EXAMPLE 85 3-Pyridinecarboxylic acid, 5-azido-6-(difluoromethyl) -4-ethyl-2-(trifluoromethyl)-,ethyl ester. To a 0° C. solution of 4.0 g (0.013 mol) of product of Example 2, 2.34 g (0.013 mol) of 48% fluoroboric acid and 30 mL of acetonitrile was added 1.46 g (0.014 mol) of t-butyl nitrite dropwise. After 30 min, a solution of 1.7 g (0.026 mol) of sodium azide in 9 mL of water was added dropwise, resulting in vigorous gas evolution. This was stirred at room temperature for 30 min, diluted with water (50 mL) and extracted with chloroform (3×25 mL). Workup as usual afforded a yellow oil. Chromatography on silica gel (2% ethyl acetate/cyclohexane) afforded 2.44 g (55%) of product as a light yellow oil; n D 25 1.476. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.61 3.28 16.56Found 42.76 3.33 16.49______________________________________ EXAMPLE 86 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[(1-methylethoxy)methylene]amino}-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.013 mol) of product of Example 2, 10 mL of triisopropyl orthoformate and 70 mg of p-toluenesulfonic acid was heated to 100° C. and stirred for 4 h. The temperature was then raised to 130° C. and stirring was continued for another 18 hours. The reaction mixture was then concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 1.58 g (32%) of product as a colorless oil; n D 25 1.502. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 49.97 4.95 7.67______________________________________ EXAMPLE 87 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(2-methylpropoxy)methylene]amino-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.012 mol) of product of Example 1, 10 mL of triisobutyl orthoformate and 70 mg of p-toluenesulfonic acid was stirred at 100° C. for 18 h, then at 120° C. for another 18 h. The reaction mixture was concentrated in vacuo. The residue was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the correct fraction gave 1.93 g (39%) of product as a light yellow oil; n D 25 1.500. ______________________________________Elemental Analysis: C H N______________________________________Calculated 53.77 5.94 6.60Found 54.30 6.00 6.34______________________________________ EXAMPLE 88 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-(2-methylpropyl)-5-(propoxymethylene) amino]-2-(trifluoromethyl)-,ethyl ester. A solution of 4.0 g (0.012 mol) of product of Example 1, 10 mL of tripropyl orthoformate and 70 mg of p-toluenesulfonic acid was stirred at 100° C. for 18 h. The reaction mixture was concentrated in vacuo and the residue was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the correct fraction gave 2.71 g (56%) of product as a colorless oil; n D 25 1.458. ______________________________________Elemental Analysis: C H N______________________________________Calculated 52.68 5.65 6.83Found 52.85 5.76 6.43______________________________________ EXAMPLE 89 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[2,2,2-trifluoro-1-(dimethylamino) ethylidene]amino}-2-(trifluoromethyl)-,ethyl ester. To a rapidly stirred solution of 4.3 g (0.010 mol) of product of Example 47 in 5 mL of dioxane was added 4.5 mL (0.025 mol) of 26% aqueous dimethylamine. An exothermic reaction occurred. When the reaction cooled to room temperature, 50 mL of water was added and the product was extracted into methylene chloride (3×25 mL). Workup as usual afforded a dark oil that was Kugelrohr distilled (130° C. @ 1 torr) to give 2.35 g 54%) of product as a yellow oil; n D 25 1.466. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.15 3.94 9.65Found 44.17 3.77 9.37______________________________________ EXAMPLE 90 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-{[2,2,2-trifluoro-1-(methylamino) ethylidene]amino}-2-(trifluoromethyl)-, ethyl ester. To a stirred solution of 4.0 g (0.0094 mol) of product of Example 47 and 5 mL of dioxane was added 2 mL of 40% aqueous methylamine. After 30 min, 50 mL of water was added and the product was extracted with methylene chloride. Workup as usual, followed by Kugelrohr distillation (170° C. @ 1 torr) gave 3.07 g (78%) of product as a white solid, mp 95°-97° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.77 3.59 9.97Found 42.59 3.63 9.98______________________________________ EXAMPLE 91 3-Pyridinecarboxylic acid, 5-[(ethoxymethylene)amino]-4-ethyl-6-methyl-2-(trifluoromethyl)-, ethyl ester. A solution of 3.5 g 0.013 mol) of product of Example 18, 10 mL of triethyl orthoformate and 70 mg of p-toluenesulfonic acid was stirred at 100° C. for the weekend. The reaction mixture was then concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 3.73 g (88%) of product as a colorless oil ; n D 25 1.477. ______________________________________Elemental Analysis: C H N______________________________________Calculated 54.21 5.76 8.43Found 54.16 5.80 8.23______________________________________ EXAMPLE 92 3-Pyridinecarboxylic acid, 5-{[(dimethylamino)methylene]amino}-4-ethyl-6-methyl-2-(trifluoromethyl)-, ethyl ester. A solution of 3.70 g (0.013 mol) of product of Example 18, 10 mL of dimethylformamide dimethyl acetal, and 70 mg of p-toluenesulfonic acid was stirred at 100° C. overnight. The reaction mixture was concentrated in vacuo and the residue was Kugelrohr distilled (150° C. @ 1 torr) to give 3.55 g (80%) of product as a yellow solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material as a white solid, mp 71°-73° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 54.37 6.08 12.68Found 54.38 6.13 12.62______________________________________ EXAMPLE 93 3-Pyridinecarboxylic acid, 5-azido-6-(difluoromethyl) -4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. To a 0° C. solution of 4.0 g (0.012 mol) of product of Example 1, 2.16 g 0.012 mol) of (48%) fluoroboric acid and 40 mL of acetonitrile was added 1.34 g of t-butyl nitrite dropwise. This was stirred at 0° C. for-20 min then a solution of 2.1 g of sodium azide in 11 mL of water was added slowly, causing immediate gas evolution. After 10 min, 50 mL of water was added and the product was extracted into chloroform. Workup as usual afforded a yellow oil which was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the first fraction gave 2.85 g (66%) of product as a light yellow oil; n D 25 1.470. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.91 4.13 15.30Found 45.71 4.21 15.37______________________________________ EXAMPLE 94 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-({1-[(1-methylethyl)thio]-2,2,2-trifluoroethylidene}amino)-2-(trifluoromethyl)-, ethyl ester. To a slurry of 0.40g (0.010 mol) of 60% sodium hydride in 7 mL of anhydrous tetrahydrofuran under a nitrogen atmosphere was added 0.74 g (0.0097 mol) of 2-propanethiol. This was stirred at room temperature for 30 min, then a solution of 4.0 g (0.0094 mol) of product of Example 47 in 5 mL of tetrahydrofuran was added dropwise. This was stirred for 30 min, diluted with 25 mL of water and extracted with ether (3×15 mL). Workup as usual, followed by Kugelrohr distillation (150° C. @ 1 torr) afforded 2.92 g (67%) of product as a yellow liquid; n D 25 1.466. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 43.78 3.89 6.01 6.87Found 44.09 3.90 5.90 6.89______________________________________ EXAMPLE 95 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-(methylamino)-2-(trifluoromethyl)ethyl ester. To 40 ml of acetic anhydride at 0° C. was added 20 ml of formic acid. This was warmed to room temperature, then was heated to 50° C. for 15 min. The flask was immediately re-cooled to 0° C. and 5.0g (0.016 mol) of product of Example 2 was added. This was stirred at room temperature for 18 hours, then was concentrated in vacuo to afford a yellow oil. This was dissolved in 15 ml of anhydrous tetrahydrofuran, and stirred at 0° C. under a dry nitrogen atmosphere. To this, 20 ml (0.04 mol) of 2.0 M borane-dimethyl sulfide complex in tetrahydrofuran was added dropwise. After the addition was complete, the reaction mixture was stirred at 70° C. for 3.5 hours. The reaction mixture was then cooled to 0° C. and 10 ml of methanol was added slowly. After frothing ceased, the mixture was warmed to room temperature and stirred for 1 hour. The 7 ml of concentrated hydrochloric acid was added and the mixture was refluxed for 1 hour. The reaction mixture was concentrated in vacuo to afford a yellow solid, which was slurried with ethyl acetate and stirred with 25 ml of 10% sodium hydroxide solution. The organic layer was separated and workup as usual gave a yellow oil. Chromatography on silica gel using 5% ethyl acetate/cyclohexane gave 2.77g of product as a yellow oil which slowly solidified, mp 38°-40° C. ______________________________________Elemental Analysi: C H N______________________________________Calculated 47.86 4.63 8.59Found 47.88 4.63 8.56______________________________________ EXAMPLE 96 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-[(2,2,2-trifluoroethyl)amino]-2-(trifluoromethyl)-, ethyl ester. To a solution of 5.16g (0.0128 mol) of product of Example 25 in 12 ml of anhydrous tetrahydrofuran at 0° C. under a nitrogen atmosphere, was added 16 ml of 2.OM borane-dimethyl sulfide complex in tetrahydrofuran dropwise. The reaction mixture was heated at 70° C. for 3 hours. Then the mixture was cooled to 0° C. and 10 ml of methanol was added carefully. After frothing ceased 10 ml of concentrated hydrochloric acid was added and the mixture was refluxed for 1 hour. The reaction mixture was concentrated in vacuo and the residue was slurried with 50 ml of ethyl acetate and stirred with 25 ml of 10% sodium hydroxide. Workup of the ethyl acetate solution afforded a yellow oil that was chromatographed on silica gel with 5% ethyl acetate/cyclohexane. Workup of the correct fraction gave 2.15g (43%) of product as a colorless oil; n D 25 1.439. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.65 3.58 7.11Found 42.93 3.58 7.13______________________________________ EXAMPLE 97 3-Pyridinecarboxylic acid, 5-azido-6-(difluoromethyl) -4-methyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0g 0.0134 mol) of product of Example 71, 2.45g 0.0134 mol) of 48% fluoroboric acid and 45 ml of acetonitrile was stirred at 0° C. and 1.44g 0.014 mol) of t-butyl nitrite was added dropwise. This was allowed to stir at 0° C. for 20 minutes, then a solution of 2.1 g of sodium azide in 11 ml of water was added dropwise, resulting in immediate gas evolution. After stirring for an additional 10 minutes the reaction mixture was diluted with water and extracted with chloroform. Workup as usual gave a yellow oil which was chromatographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the correct fraction gave 2.27g (52%) of product as a yellow oil; n D 25 1.474. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.75 2.80 17.28Found 40.96 2.71 17.03______________________________________ EXAMPLE 98 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(methoxymethylene)amino]-4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. A solution of 5.0g (0.015 mol) of product of Example 72, 10 ml of trimethyl orthoformate and 70 mg of p-toluenesulfonic acid was heated to 100° C. and stirred for 2 hours. The reaction mixture was concentrated in vacuo and the residue was kugelrohr distilled (140° C. at 1 torr) to afford 5.05g (90%) of product as a colorless oil which slowly crystallized, mp 57°-59° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.92 4.65 7.61Found 48.91 4.66 7.59______________________________________ EXAMPLE 99 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(ethoxymethylene)amino]4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. A solution of 5.0g (0.015 mol) of product of Example 72, 10 ml of triethyl orthoformate and 70 mg of p-toluenesulfonic acid was heated at 100° C. overnight. The reaction mixture was concentrated in vacuo and the residue was kugelrohr distilled (145° C. 1 torr) to give 5.07 g 8%) of product as a colorless oil; n D 25 1.464. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 50.26 5.05 7.30______________________________________ EXAMPLE 100 3-Pyridinecarboxylic acid, 6-(difluoromethyl) 4-ethyl-5-{[(dimethylamino)methylene]amino]-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.0128 mol) of product of Example 2, 10 ml of dimethylformamide dimethyl acetal and 70 mg of p-toluenesulfonic acid was refluxed overnight. The reaction mixture was concentrated in vacuo and the residue was kugelrohr distilled (145° C. at 1 torr) to afford 3.90 g (83%) of product as a yellow solid, mp 50°-52° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 49.05 4.94 11.44Found 49.02 4.93 11.33______________________________________ EXAMPLE 101 3-Pyridinecarboxylic acid, 6-(difluoromethyl -5-{[(dimethylamino)methylene]amino}-4-(1-methylethyl) -2-(trifluoromethyl)-, ethyl ester. A solution of 4.25 g (0.013 mol) of product of Example 72, 10 ml of dimethylformamide dimethyl acetal and 70 mg of p-toluenesulfonic acid was heated overnight at 100° C. The reaction mixture was concentrated in vacuo and the residue was chromatographed on silica gel using 5% ethyl acetate/cyclohexane. Workup of the correct fraction afforded 4.17 g (84%) of product as a yellow oil; n D 25 1.487. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.39 5.29 11.02Found 50.33 5.22 11.28______________________________________ EXAMPLE 102 3-Pyridinecarboxylic acid, 5-azido-6-(difluoromethyl) -4-(1-methylethyl)-2-(trifluoromethyl)-, ethyl ester. To a 0° C. solution of 4.0 g (0.012 mol) of product of Example 72, 2.25 g (0.012 mol) of 48% fluoroboric acid and 40 ml of acetonitrile was added 1.40 g (0.013 mol) of t-butyl nitrite dropwise. This was stirred at 0° C. for 20 minutes, then a solution of 2.1 g of sodium azide in 11 ml of water was added slowly, resulting in vigorous gas evolution. After stirring for 10 minutes, 100 ml of water was added and the product was extracted into chloroform (3×50 ml). Workup as usual afforded an orange oil which was chromatrographed on silica gel using 2% ethyl acetate/cyclohexane. Workup of the correct fraction gave 2.41g (56%) of product as a slightly yellow oil; n D 25 1.472. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.33 3.72 15.91Found 44.11 3.72 15.91______________________________________ EXAMPLE 103 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-ethyl-5-(sulfinylamino)-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g of product of Example 2 and 15 ml of thionyl chloride was stirred at reflux overnight. The excess thionyl chloride was removed in vacuo and the residue was kugelrohr distilled (145° C. at 1 torr) to give 4.21 g (92%) of product as a bright yellow oil; n D 25 1.477. ______________________________________Elemental Analysis: C H N S______________________________________Calculated 40.23 3.09 7.82 8.95Found 40.30 3.11 7.80 8.87______________________________________ EXAMPLE 104 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-isocyanato-4-propyl-2-(trifluoromethyl)-, ethyl ester. The product of Example 47 (5.0 g, 0.0134 mol) of European Patent Application No. 133,612 published Feb. 27, 1985, was added to 1.66 g (0.0144 mol) of azidotrimethyl silane and 10 ml of carbon tetrachloride and stirred at reflux until gas evolution ceased (˜45 minutes). The reaction mixture was concentrated in vacuo and the residue was kugelrohr distilled (130° C. at 1 torr) to give 2.65 g (50%) of product as a light yellow oil; n D 25 1.459. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.74 3.72 7.95Found 47.74 3.89 7.80______________________________________ EXAMPLE 105 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-propyl-5-[(2,2,2-trifluoro-1-methoxyethylidene)amino]-2-(trifluoromethyl)-, ethyl ester. To a solution of 2.16 g (0.01 mol) of 25% methanolic sodium methoxide in 5 ml of methanol was added a solution of 4.0 g (0.0091 mol) of product of Example 108 in 5 ml of methanol, resulting in the immediate formation of a white precipitate. The reaction mixture was stirred for 1 hour, then was poured into water (50 ml) and extracted with ether (3×15 ml). Workup as usual afforded a colorless oil which was kugelrohr distilled (130° at 1.5 torr) to give 3.27 g (82%) of product as a colorless oil; n D 25 1.438. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.05 3.70 6.42Found 44.13 3.69 6.44______________________________________ EXAMPLE 106 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(dimethylamino)methylene]amino}-4-propyl-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g (0.012 mol) of product of Example 16, 10 ml of dimethylformamide dimethyl acetal and 70 mg of p-toluenesulfonic acid was stirred at reflux overnight. The reaction mixture was then concentrated in vacuo and the residue was kugelrohr distilled (165° C. at 1.5 torr to give 4.10 g (87%) of product as a yellow oil; n D 25 1.486. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.39 5.29 11.02Found 50.50 5.29 10.99______________________________________ EXAMPLE 107 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(trifluoroacetyl)amino]-4-propyl™2™(trifluoromethyl)-, ethyl ester. A solution of 35.0 g (0.107 mol) of product of Example 16, 100 ml of methylene chloride and 30 g (0.14 mol) of trifluoroacetic anhydride was stirred at room temperature overnight. Concentration in vacuo afforded 45.7 g 100%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 95°-97° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.67 3.34 6.63Found 42.80 3.20 6.74______________________________________ EXAMPLE 108 3-Pyridinecarboxylic acid, 5-[(1-chloro-2,2,2-trifluoroethylidene) amino]-6-(difluoromethyl) -4-propyl-2-(trifluoromethyl)-, ethyl ester. A mixture of 39.58 g (0.0937 mol) of product of Example 107 and 19.51 g (0.0937 mol) of phosphorous pentachloride was heated at 135° C. for 3 hours. The reaction mixture was concentrated in vacuo and the residue was kugelrohr distilled (130° C. at 1 torr) to give 40.07 g (97%) of product as a colorless oil; n D 25 1.434. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 40.88 2.97 6.36 8.04Found 40.53 2.73 6.26 8.08______________________________________ EXAMPLE 109 3-Pyridinecarboxylic aoid, 5-[[1-(diethoxyphosphinyl) -2,2,2-trifluoroethylidene]amino]-6-(difluoromethyl)-4-propyl-2-(trifluoromethyl)-, ethyl ester. A solution of 6.0 g (0.0136 mol) of product of Example 108 and 2.26 g (0.0136 mol) of triethyl phosphine was stirred at 160° C. for 30 min. The reaction mixture was then cooled to room temperature affording 7.35 g (˜quant.) of product as a yellow oil; n D 25 1.437. ______________________________________Elemental Analysis: C H N______________________________________Calculated 42.08 4.27 5.17Found 41.68 4.29 5.14______________________________________ EXAMPLE 110 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-propyl-5-[(2,2,2-trifluoro-1-ethoxyethylidene)amino]-2-(trifluoromethyl)-, ethyl ester. To a solution of 3.24 g (0.010 mol) of 21% ethanolic sodium ethoxide and 5 ml of ethanol was added a solution of 4.0 g (0.0091 mol) of product of Example 108 in 5 ml of ethanol. This was stirred at room temperature for 15 minutes during which time a white precipitate formed. The reaction mixture was poured into water (50 ml) and extracted with ether. Workup as usual gave a yellow oil which was kugelrohr distilled (150° at 1.5 torr to give 3.87 g (84%) of product as a colorless oil; n D 25 1.438. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.34 4.03 6.22Found 45.44 4.00 6.26______________________________________ EXAMPLE 111 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-propyl-2-(trifluoromethyl)-5-[5-(trifluoromethyl) -1H-tetrazol-1-yl]-, ethyl ester. To a solution of 4.0 g (0.0091 mol) of product of Example 108 in 20 ml of tetrahydrofuran was added 0.65 g (0.01 mol) of sodium azide followed by the addition of 4 ml of water. The reaction mixture was stirred at room temperature for 30 minutes, then was diluted with water 50 ml) and extracted with chloroform (3×25 ml). Normal workup gave 3.87 g (86%) of product as a white solid. Recrystallization from ethyl acetate/cyclohexane gave analytically pure material, mp 66°-68° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.28 2.93 15.66Found 40.07 2.87 15.77______________________________________ EXAMPLE 112 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[1-(dimethylamino)-2,2,2-trifluoroethylidene]amino}-4-propyl-2-(trifluoromethyl)-, ethyl ester. To a solution of 4.0 g (0.0091 mol) of product of Example 108 and 10 ml of dioxane was added 4.5 ml of 26% aq. dimethylamine. The solution became warm immediately. This was allowed to stir for 30 minutes, then was diluted with water (50 ml) and extracted with chloroform (3×25 ml). Normal workup gave an orange oil which was kugelrohr distilled (165° C. at 1 torr) to give 3.77 g (84%) of product as a colorless 1.464. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.44 4.26 9.35Found 45.42 4.18 9.19______________________________________ EXAMPLE 113 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[2,2,2-trifluoro-1 (methylamino) ethylidene]amino}-4-propyl-2-(trifluoromethyl)-, ethyl ester. To a stirred solution of 4.0 g (0.0091 mol) of product of Example 108 and 10 ml of dioxane was added 2 ml of 40% aq. methylamine. The reaction mixture became warm. This was allowed to stir for 30 minutes, then was diluted with water (50 ml) and extracted with chloroform (3×25 ml). Normal workup gave a yellow oil which was kugelrohr distilled (165° C. at 1 torr) to give 3.53 g (89%) of product as a thick colorless oil; n D 25 1.461. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.15 3.94 9.65Found 44.25 3.77 9.38______________________________________ EXAMPLE 114 3-Pyridinecarboxylic acid, 2-(difluoromethyl) -5-[(ethoxymethylene)amino]-4-(2-methylpropyl)-6-(trifluoromethyl)-, methyl ester. A solution of 4.0 g (0.013 mol) of product of Example 209, 7.8 ml of triethyl orthoformate and 78 mg of p-toluenesulfonic acid was heated to 100° C. and stirred for 6 hours. The reaction mixture was concentrated in vacuo to give 5.39 g (100%) of product as a colorless oil. Chromatography on silica gel (1% ethyl acetate/cyclohexane) ave analytically pure material; n D 25 1.462. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 50.50 5.09 7.30______________________________________ EXAMPLE 115 3-Pyridinecarboxylic acid, 5-amino-2-(difluoromethyl) -4-ethyl-6-(trifluoromethyl)-, methyl ester. To a stirred slurry of 14.3 g of sodium azide, 25 ml of water and 75 ml of acetone was slowly added a solution of 35.77 g (0.103 mol) of methyl 5-chlorocarbonyl-2-(difluoromethyl) -4-ethyl-6-(trifluoromethyl)-3-pyridinecarboxylic in 20 ml of acetone. An exothermic reaction followed with vigorous gas evolution. The reaction mixture was allowed to cool to room temperature and diluted with water (300 ml) and extracted into chloroform (3×100 ml). Normal workup afforded 26.61 g (82%) of product as a light yellow solid. Trituration with cyclohexane gave analytically pure material, mp 54°-56° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 44.30 3.72 9.39Found 44.37 3.72 9.37______________________________________ EXAMPLE 116 3-Pyridinecarboxylic acid, 2-{difluoromethyl) -4-ethyl-5-[(methoxymethylene)amino]-6-(trifluoromethyl)-, methyl ester. A solution of 4.0 g (0.013 mol) of product of Example 115, 7.4 ml of trimethyl orthoformate and 74 mg of p-toluenesulfonic acid was refluxed overnight. The reaction mixture was then concentrated in vacuo and the residue kugelrohr distilled (150°-165° C. at 1 torr) to give 4.24 g (98%) of product as white solid, mp 67°-69° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.89 3.85 8.23Found 45.92 3.85 8.21______________________________________ EXAMPLE 117 3-Pyridinecarboxylic acid, 2-(difluoromethyl) -5-[(ethoxymethylene)amino]-4-ethyl-6-(trifluoromethyl)-, methyl ester. A solution of 4.0 g (0.013 mol) of product of Example 115, 7.8 ml of triethyl orthoformate and 78 mg of p-toluenesulfonic acid was refluxed overnight. The reaction mixture was concentrated in vacuo and the residue was kugelrohr distilled (150°-165° C. at 1 torr) to give 4.3 g (0.012 mol) of product as a white solid. Trituration with cyclohexane gave analytically pure material, mp 68°-69° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.46 4.27 7.91Found 47.37 4.30 7.90______________________________________ EXAMPLE 118 3-Pyridinecarboxylic acid, 2-(difluoromethyl) -5-[(methoxymethylene)amino]-4-(2-methylpropyl)-6-(trifluoromethyl)-, methyl ester. A solution of 3.5 g (0.011 mol) of product of Example 209, 6.7 ml of trimethyl orthoformate, and 67 mg of p-toluenesulfonic acid was refluxed for 2 hours. Reaction mixture was then concentrated in vacuo and the residue kugelrohr distilled (150°-160° C. at 1 torr) to give 3.67 g (93%) of product as a colorless oil; n D 25 1 466. ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.92 4.65 7.61Found 48.98 4.66 7.61______________________________________ EXAMPLE 119 3-Pyridinecarboxylic acid, 5-bromo-2-(difluoromethyl) -4-ethyl-6-(trifluoromethyl)-, methyl ester. To a stirred solution of 3.41 g (0.015 mol) of copper (II) bromide and 1.96 g (0.019 mol) of t-butyl nitrite in 36 ml of acetonitrile was added a solution of 4.0 g (0.013 mol) of product of Example 115 in 7 ml of acetonitrile. The reaction was stirred at room temperature for 1 hour, then was poured into 180 ml of 20% aqueous hydrochloric acid and extracted with ether (3×50 ml). Normal workup followed by kugelrohr distillation (130°-145° C. at 1 torr) gave 3.63 g (79%) of product as a colorless oil. Chromatography of a small amount of product on silica gel (2% ethyl acetate/cyclohexane) gave an analytically pure white solid, mp 25 49°-51° C. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 36.49 2.51 3.87 22.07Found 37.14 2.59 3.92 22.39______________________________________ EXAMPLE 120 3-Pyridinecarboxylic acid, 5-chloro-2-(difluoromethyl) -4-ethyl-6-(trifluoromethyl)-, methyl ester. To a stirred solution of 2.05 g (0.015 mol) of copper (II) chloride and 1.96 g (.019 mol) of t-butyl nitrite in 36 ml of acetonitrile was added a solution of 4.0 g (0.013 mol) of product of Example 115 in 7 ml of acetonitrile. The reaction was stirred at room temperature for 1 hour. The reaction mixture was poured into 180 ml of 20% aqueous hydrochloric acid and extracted with ether (3×50 ml). Workup as usual followed by kugelrohr distillation (130°-145° C.) gave 3.28 g (81%) of product as a colorless oil. Chromatography of a small amount of product on silica gel (2% ethyl acetate/cyclohexane) gave analytically pure material; n D 25 1.454. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 41.59 2.86 4.41 11.16Found 41.72 2.88 4.47 11.20______________________________________ EXAMPLE 121 3-Pyridinecarboxylic acid, 2-(difluoromethyl) -4-ethyl-5-iodo-6-(trifluoromethyl)-, methyl ester. To a stirred solution of 3.98 g (0.013 mol) of product of Example 115, 2.32 g (0.013 mol) of 48% fluoroboric acid and 33 ml of acetonitrile in an ice bath was slowly added 1.44 g 0.014 mol) of t-butyl nitrite. The solution was stirred at 0° C. for 30 minutes and then added to a rapidly stirred solution of 33.17 g (0.20 mol) of potassium iodide in 120 ml water. After 30 minutes, the reaction mixture was diluted with 120 ml of water and extracted with chloroform (3×75 ml). The chloroform solution was washed with 10% sodium thiosulfate solution (2×75 ml). Workup as usual followed by kugelrohr distillation (140°-165° C. at 1 torr) gave 3.75 g (72%) of product as an off-white solid, mp 63°-65° C. Chromatography of a small amount of product on silica gel (2% ethyl acetate/cyclohexane gave an analytically pure white solid, mp 72°-73° C. ______________________________________Elemental Analysis: C H N I______________________________________Calculated 32.30 2.22 3.42 31.02Found 32.12 2.23 3.37 30.98______________________________________ EXAMPLE 122 3-Pyridinecarboxylic acid, 5-bromo-2-(difluoromethyl) -4-(2-methylpropyl)-6-(trifluoromethyl) -, methyl ester. To a stirred solution of 16.22 g (0.072 mol) of copper (II) bromide and 9.32 g (0.091 mol) of t-butyl nitrite in 170 ml of acetonitrile was added a solution of 19.71 g (0.060 mol) of product of Example 209 in 34 ml of acetonitrile. The reaction was stirred at room temperature for 1 hour. The reaction mixture was poured into 856 ml of 20% hydrochloric acid and then extracted with ether. Normal workup yielded 20.22 g (86%) of product as a bright yellow oil. Chromatography on silica gel (1% ethyl acetate/cyclohexane) yielded 12.24 g (52%) of product as a colorless oil; n D 25 1.472. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 40.02 3.36 3.59 20.48Found 40.15 3.37 3.58 20.42______________________________________ EXAMPLE 123 3-Pyridinecarboxylic acid, 5-amino-6-(difluoromethyl) -4-(2-methylpropyl)-2-(trifluoromethyl) -, methyl ester. To a stirred slurry of 26.9 g (0.414 mol) of sodium azide, 47 ml of water and 158 ml acetone was slowly added a solution of 62.53 g (0.168 mol) of methyl 5-chlorocarbonyl-6-(difluoromethyl)-4-(2-methylpropyl) -2-(trifluoromethyl)-3-pyridinecarboxylate in 21 ml of acetone. An exothermic reaction followed with vigorous gas evolution. The reaction was allowed to cool to room temperature and diluted with 565 ml water and extracted with chloroform (3×100 ml). Workup as usual gave 52.9 g (97%) of product as a light yellow solid. Chromatography on silica gel (20% ethyl acetate/cyclohexane to elute product) gave 37.25 g (68%) of analytically pure material, mp 104°-106° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.86 4.63 8.59Found 47.78 4.68 8.56______________________________________ EXAMPLE 124 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(methoxymethylene)amino]-4-(2-methylpropyl) -2-(trifluoromethyl)-, methyl ester. A solution of 3.25 g (0.01 mol) of product of Example 123, 6.0 ml of trimethyl orthoformate, and 60 mg of p-toluenesulfonic acid was stirred for 28 hours at 100° C. The reaction mixture was concentrated in vacuo and kugelrohr distilled (145°-155° C. at 1 torr) to yield 3.39 g (92%) of product as a colorless oil. Chromatography of product on silica gel (2% ethyl acetate/cyclohexane) gave analytically pure material; n D 25 1.466. ______________________________________Elemental Analysis: C H N______________________________________Calculated 48.92 4.65 7.61Found 48.84 4.69 7.61______________________________________ EXAMPLE 125 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-[(ethoxymethylene)amino]-4-(2-methylpropyl)-2-(trifluoromethyl)-, methyl ester. A solution of 3.25 g (0.010 mol) of product of Example 123, 6.2 ml of triethyl orthoformate and 62 mg of p-toluenesulfonic acid was stirred at 100° C. for 8 hours. An additional 62 mg of p-toluenesulfonic acid was added and the reaction was complete 20 hours later. The reaction mixture was concentrated in vacuo and kugelrohr distilled (135°-145° C. at 1 torr) to give 3.8 g (99%) of product as a colorless oil; n D 25 1.4655. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.26 5.01 7.33Found 50.32 5.02 7.23______________________________________ EXAMPLE 126 3-Pyridinecarboxylic acid, 2-(difluoromethyl) -5-[[(dimethylamino)methylene]amino]-4-ethyl-6-(trifluoromethyl)-, methyl ester. A stirred solution of 4.0 g (0.013 mol) of product of Example 115, 10 ml of dimethylformamide dimethyl acetal, and 70 mg of p-toluenesulfonic acid was refluxed overnight. The reaction mixture was concentrated in vacuo and kugelrohr distilled (170°-185° C. at 1 torr) to give 3.98 g of product as a yellow solid, mp 89°-91° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.60 4.56 11.89Found 47.63 4.59 11.88______________________________________ EXAMPLE 127 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(dimethylamino)methylene]amino]-4-(2-methylpropyl) -2-(trifluoromethyl)-, methyl ester. A stirred solution of 4.0 g (0.012 mol) of product of Example 123, 10 ml of dimethylformamide dimethyl acetal, and 70 mg p-toluenesulfonic acid was refluxed overnight. The reaction mixture was concentrated in vacuo and the residue kugelrohr distilled (170°-185° C. at 1 torr) to give 4.11 g (88%) of product as yellow liquid that slowly solidified, mp 59°-60° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 50.39 5.29 11.02Found 50.41 5.28 10.98______________________________________ EXAMPLE 128 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[(dimethylamino)methylene]amino}-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. A solution of 4.0 g of product of Example 1, 9 ml of dimethylformamide dimethyl acetal, and 91 mg of p-toluenesulfonic acid was stirred at reflux for 3 hours. The reaction mixture was concentrated in vacuo and the residue kugelrohr distilled (185°-200° C. at 1 torr) to yield a brown oil. Chromatography on silica gel (7% ethyl acetate/cyclohexane) gave 3.29 g (71%) of product as a colorless oil; n D 25 1.486. ______________________________________Elemental Analysis: C H N______________________________________Calculated 51.64 5.61 10.63Found 51.73 5.62 10.61______________________________________ EXAMPLE 129 3-Pyridinecarboxylic acid, 5-azido-2-(difluoromethyl) -4-ethyl-6-(trifluoromethyl)-, methyl ester. To a 0° C. solution of 5.0 g (0.016 mol) of product of Example 115, 2.9 g (0.016 mol) of 48% fluoroboric acid, and 52 ml of acetonitrile was added 1.75 g (0.017 mol) of t-butyl nitrite dropwise. The reaction mixture was stirred at 0° C. for 20 minutes, then a solution of 2.72 g 0.042 mol) of sodium azide in 14 ml of water was added. Vigorous gas evolution followed. The reaction was stirred for 10 minutes at room temperature, then diluted with 100 ml of water and extracted with chloroform (3×25 ml). Normal workup afforded 5.07 g (98%) of product as an orange oil. Chromatography on silica gel (2% ethyl acetate/cyclohexane) gave 2.61 g (50%) of product as a colorless oil; n D 25 1.570. ______________________________________Elemental Analysis: C H N______________________________________Calculated 40.75 2.80 17.28Found 40.82 2.77 17.10______________________________________ EXAMPLE 130 3-Pyridinecarboxylic acid,5-(1-chloro-2,2,2-trifluoroethylidene) amino]-6-(difluoromethyl)-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. A mixture of 37.65 g (0.086 mol) of product of Example 7 and 17.97 g (1 equivalent) of PCls was stirred overnight at 130° C. in a flask fitted with a reflux condenser and a drying tube. The reaction mixture was concentrated in vacuo, then kugelrohr distilled at 90° C. to remove low-boiling impurities and finally at 130° C. to afford 35.78 g (0.078 mol) of product as a yellow oil which gradually solidified. Yield was 91%. mp 33.0°-34.0° C. ______________________________________Elemental Analysis: C H N Cl______________________________________Calculated 42.26 3.32 6.16 7.80Found 42.69 3.39 6.22 7.86______________________________________ EXAMPLE 131 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-(2-methylpropyl)-5- (2,2,2-trifluoro-1-methoxyethylidene)amino]-2-(trifluoromethyl)-, ethyl ester. To a room temperature solution of 2.09 g (0.010 mol) of 25% sodium methoxide/methanol and 5 ml of methanol was added a solution of 4.0 g 0.009 mol) of product of Example 130 in 4.7 ml methanol. A yellow precipitate formed immediately and the reaction mixture was stirred at room temperature for 1 hour, then diluted with 25 ml of water and extracted with ether (3×20 ml . Workup as usual followed by kugelrohr distillation (135° C. at 1 torr) gave 2.57 g (65%) of product as a colorless oil. Chromatography on silica gel (0.5% ethyl acetate/cyclohexane) gave 1.89 g (48%) of pure product as a colorless oil; n D 25 1.438. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.34 4.03 6.22Found 45.32 3.91 6.25______________________________________ EXAMPLE 132 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -4-(2-methylpropyl)-2-(trifluoromethyl)-5-[(2,2,2-trifluoro-1-ethoxyethylidine) amino]-, ethyl ester. To a solution of 3.24 g (0.010 mol) of 21% sodium ethoxide/ethanol and 5 ml of ethanol was added a solution of 4.0 g (0.009 mol) of product of Example 130 in 5 ml ethanol. The reaction was stirred at room temperature for 15 minutes. The reaction mixture was diluted with 100 ml water and extracted with ether (3×25 ml) which was worked up as usual. Kugelrohr distillation (135°-145° C. at 1 torr) gave 2.87 g (70%) of product as a colorless oil. Chromatography on silica gel (1% ethyl acetate/cyclohexane) gave 1.89 g (46%) of product as a colorless oil; n D 25 1.439. ______________________________________Elemental Analysis: C H N______________________________________Calculated 46.56 4.34 6.03Found 46.64 4.34 6.14______________________________________ EXAMPLE 133 3-Pyridinecarboxylic acid, 5-{[1-(dimethylamino) -2,2,2-trifluoroethylidene]amino-6-(difluoromethyl) -4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. To a room temperature solution of 4.0 g (0.009 mol) of product of Example 130 and 10 ml of dioxane was added 4.5 ml (0.026 mol) of 26% aqueous solution of dimethylamine. The solution became warm and was stirred for 30 minutes. The reaction mixture was diluted with 250 ml of water and extracted with chloroform (3×30 ml). Workup as usual gave a brown oil which was kugelrohr distilled (165° C. at 1 torr) to give 2.06 g (50%) of product as a yellow oil; n D 25 1.467. ______________________________________Elemental Analysis: C H N______________________________________Calculated 46.66 4.57 9.07Found 46.44 4.56 9.01______________________________________ EXAMPLE 134 3-Pyridinecarboxylic acid, 6-(difluoromethyl) -5-{[1-(methylamino)-2,2,2-trifluoroethylidene]amino}-4-(2-methylpropyl)-2-(trifluoromethyl)-, ethyl ester. To a room temperature solution of 4.0 g (0.009 mol) of product of Example 130 in 10 ml dioxane was added 2 ml (0.026 mol) of 40% aqueous methylamine. The reaction became warm and was stirred for 30 minutes. The reaction mixture was diluted with 250 ml of water and extracted with chloroform (3×30 ml). Normal workup gave a yellow oil which was kugelrohr distilled (175° C. at 1 torr) to yield product as a thick yellow oil; n D 25 1.454. ______________________________________Elemental Analysis: C H N______________________________________Calculated 45.44 4.26 9.35Found 45.54 4.27 9.18______________________________________ EXAMPLE 135 Ethyl 2,6-bis-trifluoromethyl)-5-bromo-4-hydroxy -3-pyridinecarboxylate. The precursor ethyl 2,6-bis(trifluoromethyl)-4-hydroxy-3-pyridinecarboxylate was prepared as follows: To a flame dried 3-liter, four-necked flask equipped with nitrogen inlet, low temperature thermometer, 500 ml addition funnel and mechanical stirrer was charged 91.0 g (126 ml, 0.899 mol) of diisopropylamine and 500 ml of dry tetrahydrofuran. The resulting solution was cooled to -78° C. using an acetone-dry ice bath. To this was slowly added 383 ml (0.880 mol) of 2.3M n-BuLi in hexane at such a rate that the reaction temperature was kept below -60° C. After stirring at -78° C. for 1 hour, a solution of 90.0 g (0.400 mol) of ethyl 2-acetyl-3-amino-4,4,4-trifluoro 2-butenoate in 150 ml of dry tetrahydrofuran was added in such a rate that the reaction temperature was kept below -60° C. The reaction mixture turned yellow and a solid suspension formed. After 1 hour of stirring at -78° C., the reaction mixture was treated with 184.7 g (155 ml, 1.300 mol) of ethyl trifluoroacetate in such rate that the reaction temperature was kept below -60° C. This reaction mixture was left at -78° C. for 1 hour, then warmed to room temperature (the yellow suspension disappeared and a brown solution was formed) and stirred for 18 hours. The resulting solution was poured into 1.5 L of 10% HCl (aqueous) and extracted 3 times with methylene chloride. The combined methylene chloride layers were dried (MgSO 4 ) and reduced in vacuo affording a thick brown oil. The residue was kugelrohr distilled at 47 Pa. The earlier fraction (pot temperature 50° C.) was discarded. The later fraction (pot temperature 80° C.) afforded 80.0 g (66%) of the pyridine intermediate; mp 70°-77° C. To a solution of 5.0 g (0.165 mol) of the compound prepared above in 50 mL of 10% NaOH was added 5 mL of bromine. An exothermic reaction occurred instantly. The reaction mixture was stirred for 5 minutes and poured into a mixture of 20 mL of concentrated HCl and 50 mL of water. To the above mixture was added sodium sulfite until all red bromine color disappeared. The white oil precipitate was extracted into ether. The ether solution was dried and concentrated. The residue was kugelrohr distilled at 0.8 mm (pot temperature 95° C.) to give 5.7 g of an oil which was crystallized from petroleum ether at low temperature to give 3.5 g (55.9%) of product, mp 30°-32° C., which turned into a liquid upon standing, n D 25 1.4646. ______________________________________Elemental Analysis: C H N Br______________________________________Calculated 31.44 1.58 3.67 20.92Found 31.30 1.59 3.64 20.86______________________________________ Using preparative techniques similar to those set out in detail above in Examples 1 through 136, additional compounds were prepared. These additional compounds are shown in the following Table 1, along with a physical property for each where available. TABLE 1__________________________________________________________________________ ##STR12##Example R.sub.1 R.sub.2 R Ra X MP (°C.) n.sub.D.sup.25__________________________________________________________________________136 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHSCH.sub.3 Cyclobutyl 59.8-64.8137 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 Br Isobutyl 1.473138 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHSCH.sub.2 CH.sub.3 Cyclobutyl139 CF.sub.3 CF.sub.3 OCH.sub.2 CH.sub.3 NH.sub.2 Methoxy 70.0-71.0140 CF.sub.3 CF.sub.3 OCH.sub.2 CH.sub.3 Br Methoxy 1.449141 CF.sub.3 CF.sub.3 OCH.sub.2 CH.sub.3 I Methoxy 39.0-40.0142 CF.sub.3 CF.sub.2 H SCH.sub.3 ##STR13## Isobutyl 1.518143 CF.sub.3 CF.sub.2 H SCH.sub.3 NCHOCH.sub.2 CH.sub.3 Cyclopropylmethyl 1.480144 CF.sub.3 CF.sub.2 H SCH.sub.3 ##STR14## Isobutyl 96.0-97.0145 CF.sub.3 CF.sub.2 H OCH.sub.3 Br Cyclobutyl 50.0-54.0146 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR15## Cyclobutyl 83.0-83.7147 CF.sub.3 CF.sub.2 H OCH.sub.3 Br Isobutyl 1.471148 CF.sub.3 CH.sub.3 OCH.sub.2 CH.sub.3 NH.sub.2 Isobutyl 94.0-96.0149 CF.sub.3 CH.sub.3 OCH.sub.2 CH.sub.3 NCHOCH.sub.3 Isobutyl 1.477150 CF.sub.3 CH.sub.3 OCH.sub.2 CH.sub.3 Br Isobutyl 1.483151 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 ##STR16## Propyl 82.0-84.0152 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR17## Cyclobutyl153 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 NSO Propyl 1.476154 CF.sub.3 CF.sub.2 H SCH.sub.3 ##STR18## Isobutyl 1.493155 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 ##STR19## Isobutyl 1.442156 CF.sub.2 H CF.sub.3 OCH.sub.3 NCHN(CH.sub.3).sub.2 Isobutyl 54.0-57.0157 CF.sub.3 CH.sub.3 OCH.sub.2 CH.sub.3 NCHN(CH.sub.3).sub.2 Isobutyl 1.497158 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 NHCH.sub.3 Isobutyl 1.473159 CF.sub.3 CH.sub.3 OCH.sub.2 CH.sub.3 NO.sub.2 Isobutyl 1.465160 CF.sub.2 H CF.sub.3 OCH.sub.3 NO.sub.2 Ethyl 1.451161 CF.sub.3 CF.sub.2 H SCH.sub.3 ##STR20## Isobutyl 1.502162 CF.sub.3 CF.sub.2 H OCH.sub.3 NCO Isobutyl 1.466163 CF.sub.3 CF.sub.2 H OCH.sub.3 NSO Isobutyl 1.479164 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 ##STR21## Propyl 64.0-66.0165 CF.sub.2 H CF.sub. 3 OCH.sub.3 NSO Isobutyl 1.482166 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR22## Isobutyl 168.0-171.0167 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 ##STR23## Isobutyl 1.418168 CF.sub.3 CF.sub.2 H SCH.sub.3 NH.sub.2 Isobutyl 108.0-110.0169 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 ##STR24## Isobutyl 90.0-92.0170 CF.sub.3 CF.sub.2 H SCH.sub.3 NCHN(CH.sub.3).sub.2 Isobutyl 70.0-71.0171 CF.sub.3 CF.sub.2 H SCH.sub.3 NCHOCH.sub.3 Isobutyl 1.494172 CF.sub.3 CF.sub.2 H SCH.sub.3 NCHOCH.sub.2 CH.sub.3 Isobutyl 1.492173 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 NCHSCH.sub.3 Isobutyl 1.4925174 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR25## Isobutyl 118.0-120.0175 CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 NSO Isobutyl 1.477176 CF.sub.3 CF.sub.2 H SCH.sub.3 Br Isobutyl 37.0-38.0177 ##STR26##177 (cont.) CF.sub.3 CF.sub.2 H OCH.sub.2 CH.sub.3 ##STR27## Isobutyl178 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHSCH.sub.3 Isobutyl 1.493179 CF.sub.3 CF.sub.2 H OCH.sub.3 N(CHO).sub.2 Isobutyl 1.457180 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHSCH.sub.2 CH.sub.3 Isobutyl 1.493181 CF.sub.2 H CF.sub.3 OCH.sub.3 ##STR28## Isobutyl 182.0-184.0182 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR29## Isobutyl 1.488183 CF.sub.2 H CF.sub.3 OCH.sub.3 ##STR30## Isobutyl 1.494184 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR31## Isobutyl 112.0-114.0185 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR32## Isobutyl 1.483186 CF.sub.2 H CF.sub.3 OCH.sub.3 ##STR33## Isobutyl 160.0-161.0187 CF.sub.2 H CF.sub.3 SCH.sub.3 Br Isobutyl 1.507188 CF.sub.3 CF.sub.2 H SCH.sub.2 CH.sub.3 NCHN(CH.sub.3).sub.2 Isobutyl 1.511189 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR34## Isobutyl 1.470190 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR35## Isobutyl 1.4845191 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR36## Isobutyl 1.462192 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR37## Isobutyl 1.477193 CF.sub.3 CF.sub.2 H OCH.sub.3 NCFCH.sub.3 Isobutyl 158.0-160.0194 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR38## Isobutyl 1.492195 CF.sub.3 CF.sub.2 H OCH.sub.3 ##STR39## Isobutyl 118.0-119.0196 CF.sub.3 CF.sub.2 H SCH.sub.3 NCHSCH.sub.3 Isobutyl 1.523197 CF.sub.3 CF.sub.2 H SCH.sub.3 NHCOCH.sub.3 Isobutyl 140.0-142.0198 CF.sub.3 CF.sub.2 H SCH.sub.3 NH.sub.2 Cyclopropylmethyl 90.0-92.0199 CF.sub.3 CF.sub.2 H SCH.sub.3 NCHN(CH.sub.3).sub.2 Cyclopropylmethyl 109.0-112.0200 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHOCH.sub.3 Cyclobutyl 64.0-66.0201 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHOCH.sub.2 CH.sub.3 Cyclobutyl 48.0-52.0202 CF.sub.3 CF.sub.2 H OCH.sub.3 NCHN(CH.sub.3).sub.2 Cyclobutyl 86.6-88.4203 CF.sub.3 CF.sub.2 H OCH.sub.3 NH.sub.2 Cyclobutyl 88.8-90.5204 CF.sub.2 H CF.sub.3 OCH.sub.3 NH.sub.2 Cyclobutyl 89.0-92.8205 CF.sub.2 H CF.sub.3 OCH.sub.3 NCHOCH.sub.3 Cyclobutyl206 CF.sub.2 H CF.sub.3 OCH.sub.3 NCHOCH.sub.2 CH.sub.3 Cyclobutyl207 CF.sub.2 H CF.sub.3 OCH.sub.3 NCHN(CH.sub.3).sub.2 Cyclobutyl 69.0-74.0208 CF.sub.2 H CF.sub.3 OCH.sub.3 Br Cyclobutyl__________________________________________________________________________ PG,85 EXAMPLE 209 3-Pyridinecarboxylic acid, 5-amino-2-(difluoromethyl) -4-(2-methylpropyl)-6-(trifluoromethyl)-, methyl ester. To a stirred slurry of 27.8 g of sodium azide, 50 ml of water and 164 ml of acetone was slowly added a solution of 65.2 g (0.183 mol) of methyl 5-chlorocarbonyl -6-(difluoromethyl)-4-(2-methylpropyl)-2-(trifluoromethyl)-3-pyridinecarboxylate in 16 ml of acetone. An exothermic reaction followed with vigorous gas evolution. The reaction mixture was allowed to cool to room temperature and diluted with water (500 ml) and extracted into chloroform (3×100 ml). Normal workup afforded 51.93 g (94%) of product as green solid. Chromatography on silica gel (10% ethyl acetate/cyclohexane) gave analytically pure material, mp 48°-50° C. ______________________________________Elemental Analysis: C H N______________________________________Calculated 47.86 4.63 8.59Found 47.81 4.63 8.58______________________________________ PRE-EMERGENT HERBICIDE EXAMPLES As noted above, many of the compounds of this invention have been found to be effective as pre-emergent and post-emergent herbicides. Table 2 summarizes results of tests conducted to determine the pre-emergent herbicidal activity of the compounds of this invention on common weeds. The pre-emergent tests are conducted as follows: Top soil is placed in aluminum pans and compacted to a depth of 0.95 to 1.27 cm. from the top of the pan. On the top of the soil is placed a predetermined number of seeds or vegetative propagules of various plant species. The soil required to level fill the pans after seeding or adding vegetative propagules is weighed into a pan. A known amount of the active ingredient applied in acetone as a solvent is thoroughly mixed with the soil, and the herbicide/soil mixture is used as a cover layer for prepared pans. In Table 3 below the amount of active ingredient is equal to the rate of 11.2 kg/ha. After treatment, the pans are moved to a greenhouse bench where they are watered from below as needed to give adequate moisture for germination and growth. Approximately 10-14 days (usually 11 days) after seeding and treating, the pans are observed and the results recorded. In some instances, a second observation is made approximately 24-28 days after seeding and treating, and these observations are indicated in the following tables by an asterisk (*) immediately following the Example number. Table 2 below summarizes the results of the pre-emergent herbicidal activity tests of compounds of this invention in weeds. The herbicidal rating is obtained by means of a fixed scale based on the percent inhibition of each plant species. The symbols in the Table are defined as follows: ______________________________________% Inhibition Rating______________________________________ 0-24 025-49 150-74 2 75-100 3Not planted --Species planted, Nno data______________________________________ WEED-PLANT HERBICIDE ACTIVITY The plant species usually regarded as weeds which are utilized in one set of tests, the data for which are shown in Table 3, are identified by letter headings above the columns in accordance with the following legend: ______________________________________ A - Canada Thistle* B - Cocklebur C - Velvetleaf D - Morningglory E - Common Lambsquarters F - Pennsylvania Smartweed G - Yellow Nutsedge* H - Quackgrass* I - Jonhsongrass* J - Downy Brome K - Barnyardgrass______________________________________ *Grown from vegetative propagules TABLE 2______________________________________PRE-EMERGENT ACTIVITY FOR WEEDSExample No. Kg/ha A B C D E F G H I J K______________________________________ 1 11.2 0 0 1 2 3 3 0 3 0 3 3 2 11.2 0 0 3 3 3 3 0 2 -- 3 3 3 11.2 0 0 1 2 3 2 0 3 3 1 3 4 11.2 0 0 0 0 1 3 0 0 3 0 1 5 11.2 3 2 3 3 3 3 2 2 3 3 3 6 11.2 0 0 3 1 3 3 0 0 3 3 3 7 11.2 3 0 2 3 3 2 0 0 3 2 2 8 11.2 0 0 0 0 0 1 0 3 3 3 3 9 11.2 3 0 2 3 3 3 0 1 N 3 3 10 11.2 3 N 2 3 3 2 1 3 3 3 3 11 11.2 0 1 1 3 2 2 0 3 3 3 3 12 11.2 3 1 1 3 3 3 0 3 -- 3 3 13 11.2 3 1 2 3 3 3 0 3 3 3 3 14 11.2 3 0 2 3 3 3 3 3 -- 3 3 15 11.2 1 1 3 3 3 3 2 3 3 3 3 16 11.2 3 0 3 3 3 3 0 2 0 2 3 17 11.2 -- 1 3 3 3 3 0 3 2 3 3 18 11.2 -- N 0 0 3 0 0 0 0 0 1 19 11.2 -- 0 1 2 3 3 0 3 3 3 3 20 11.2 -- 1 0 0 0 1 0 0 0 0 1 21 11.2 -- 0 0 0 0 0 0 0 0 2 0 22 11.2 -- 0 0 0 0 2 0 0 0 2 2 23 11.2 -- 1 1 0 0 1 1 0 1 0 1 24 11.2 -- 0 0 0 0 0 0 0 3 0 0 25 11.2 1 N 1 0 3 1 0 0 0 0 2 26 11.2 -- 0 2 0 3 2 0 0 0 1 2 26* 11.2 -- 0 2 0 3 1 0 0 0 1 2 27 11.2 -- 0 3 3 N 3 0 0 0 0 0 28 11.2 -- 2 3 3 3 3 0 1 1 1 1 29 11.2 -- 0 0 0 2 2 0 0 0 3 3 30 11.2 -- 0 0 0 0 0 0 0 0 1 0 31 11.2 -- 2 2 0 0 3 0 0 0 1 3 32 11.2 -- 3 3 3 3 3 0 3 3 3 3 33 11.2 -- 1 3 3 3 3 0 3 3 3 3 34 11.2 -- 0 3 3 3 3 0 3 3 3 3 35 11.2 -- 2 3 3 3 3 2 3 3 3 3 36 11.2 -- 0 3 3 3 3 0 3 0 3 3 37 11.2 -- 0 3 3 3 2 0 3 0 3 3 38 11.2 -- 1 3 3 3 3 1 3 3 3 3 39 11.2 -- 2 3 3 3 3 2 3 3 3 3 40 11.2 -- 0 3 3 3 3 0 3 3 3 3 41 11.2 -- 0 0 0 3 3 0 0 N 0 3 42 11.2 -- 0 2 0 2 3 0 0 N 1 3 43 11.2 -- 0 0 0 3 3 0 0 0 3 3 44 11.2 -- 0 0 0 3 3 0 0 0 0 3 45 11.2 -- 0 1 0 3 3 0 0 0 3 3 46 11.2 -- 1 0 0 3 3 1 0 0 1 0 47 11.2 -- 0 0 2 1 3 0 1 0 3 3 49 11.2 -- 1 1 1 3 3 0 3 3 3 3 50 11.2 -- 0 0 0 1 2 0 1 2 3 3 51 11.2 -- 0 1 0 3 1 0 0 0 0 0 52 11.2 -- 0 1 1 3 3 0 2 0 3 3 53 11.2 -- 0 2 3 3 3 0 3 1 3 3 54 11.2 -- 3 3 3 3 3 1 3 1 3 3 55 11.2 -- 0 2 2 1 2 0 3 0 3 3 56 11.2 -- 0 1 3 3 3 0 2 0 3 3 57 11.2 -- 1 3 3 3 3 0 3 1 3 3 58 11.2 -- 0 2 1 3 2 0 3 0 3 3 59 11.2 -- 1 2 1 2 2 0 0 0 1 3 60 11.2 -- 0 2 1 3 3 0 0 0 3 3 61 11.2 -- 0 0 0 1 0 0 0 0 0 3 62 11.2 -- 0 0 0 0 0 0 0 0 0 2 63 11.2 -- 0 1 0 3 2 0 2 0 2 3 64 11.2 -- 0 0 0 0 1 0 3 1 0 3 65 11.2 -- 0 3 0 1 1 0 2 0 0 3 66 11.2 -- 3 0 0 0 0 0 0 3 0 0 67 11.2 -- 0 2 0 0 0 0 1 N 0 0 68 11.2 -- 3 3 3 3 3 0 0 0 3 3 69 11.2 -- 3 0 3 3 2 0 0 0 1 3 70 11.2 -- 0 0 0 0 0 0 0 0 0 0 71 11.2 0 1 3 3 3 3 0 1 1 2 3 72 11.2 1 0 3 3 3 3 0 3 0 3 3 73 11.2 0 3 0 3 1 1 0 3 3 3 3 74 11.2 0 3 0 3 3 3 0 3 0 3 3 75 11.2 0 3 1 3 3 3 0 1 0 3 3 76 11.2 -- 0 2 3 3 3 0 3 3 3 3 77 11.2 -- 0 2 3 3 3 0 3 0 3 3 78 11.2 -- 1 2 3 3 3 0 3 0 3 3 79 11.2 -- 0 1 3 3 3 0 3 1 3 3 80 11.2 -- 0 1 3 3 3 0 3 0 3 3 81 11.2 -- 0 3 3 3 3 1 3 0 3 3 82 11.2 -- 1 0 3 2 1 0 3 3 3 3 83 11.2 -- 0 1 3 3 3 0 3 0 3 3 84 11.2 -- 1 2 3 3 3 0 3 1 3 3 85 11.2 -- 1 3 3 3 3 2 3 3 3 3 86 11.2 -- 0 3 3 3 3 0 3 2 3 3 87 11.2 -- 0 1 1 1 1 0 0 N 1 3 88 11.2 -- 0 2 2 3 3 0 2 N 3 3 89 11.2 -- 0 3 3 3 3 0 2 2 3 3 90 11.2 -- 0 3 3 3 3 0 0 0 2 3 91 11.2 -- 0 2 3 3 1 0 0 N 2 3 92 11.2 -- 0 2 3 3 2 0 1 0 2 3 93 11.2 -- 0 0 1 3 3 0 0 0 3 3 94 11.2 -- 1 0 0 1 0 0 0 0 3 3 95 11.2 -- 1 2 3 3 3 0 3 2 3 3 96 11.2 -- 0 3 3 3 3 0 3 0 3 3 97 11.2 -- 0 2 3 3 3 0 3 3 3 3 98 11.2 3 1 3 3 3 3 1 3 2 3 3 99 11.2 -- 1 3 3 3 3 0 3 0 3 3 100 11.2 -- 2 3 3 3 3 2 3 3 3 3 101 11.2 3 0 3 3 3 3 0 3 0 3 3 102 11.2 0 1 3 3 3 3 1 3 0 3 3 103 11.2 1 1 3 2 3 3 0 1 0 3 3 104 11.2 0 0 1 2 3 3 0 0 0 1 3 105 11.2 0 1 2 3 3 3 0 3 3 3 3 106 11.2 2 2 3 3 3 3 0 3 0 3 3 107 11.2 2 0 1 1 3 1 0 0 0 0 1 108 11.2 1 1 0 2 3 2 0 0 0 0 0 109 11.2 0 1 0 3 3 3 1 0 0 0 3 110 11.2 1 0 1 1 2 1 0 0 0 3 3 111 11.2 1 0 0 0 2 1 0 0 2 1 3 112 11.2 3 0 3 3 3 3 0 0 0 3 3 113 11.2 0 0 3 3 3 3 0 0 3 3 3 114 11.2 3 3 3 3 3 3 3 3 3 3 3 115 11.2 0 1 3 3 3 3 0 0 3 3 3 116 11.2 1 3 3 3 3 3 1 3 1 3 3 117 11.2 3 1 3 3 3 3 1 3 3 3 3 118 11.2 3 3 3 3 3 3 3 3 3 3 3 119 11.2 0 0 2 3 3 3 3 3 0 3 3 120 11.2 0 0 1 2 2 3 0 3 0 3 3 121 11.2 3 0 3 3 3 3 1 3 3 3 3 122 11.2 1 0 3 3 3 3 2 3 0 3 3 123 11.2 1 1 3 2 3 3 0 0 0 3 3 124 11.2 3 2 3 3 3 3 3 3 3 3 3 125 11.2 3 3 3 3 3 3 3 3 3 3 3 126 11.2 1 1 3 3 3 3 0 3 2 3 3 127 11.2 3 3 3 3 3 3 3 3 3 3 3 128 11.2 3 2 3 3 3 3 3 3 3 3 3 129 11.2 3 1 3 3 3 3 3 3 3 3 3 130 11.2 2 1 3 3 3 3 0 3 0 2 3 131 11.2 0 1 3 3 3 3 0 3 3 3 3 132 11.2 0 0 1 0 0 0 0 2 1 3 3 133 11.2 0 0 3 3 3 3 0 2 0 3 3 134 11.2 0 0 3 3 3 3 0 2 0 3 3 135 11.2 0 1 2 2 3 3 0 N 0 0 0 135* 11.2 0 0 1 2 3 2 0 N 0 0 0 136 11.2 3 2 3 3 3 3 1 3 3 -- 3 137 11.2 3 1 0 1 2 2 0 3 -- 3 3 138 11.2 0 0 1 2 3 3 0 2 3 -- 3 139 11.2 0 0 0 1 0 0 0 0 0 0 3 140 11.2 3 0 0 2 0 0 0 0 N 0 0 141 11.2 0 0 0 2 3 3 0 0 N 3 3 142 11.2 3 3 3 3 3 3 2 3 3 -- 3 143 11.2 3 2 3 3 3 3 2 3 3 -- 3 144 11.2 3 0 3 3 3 3 1 3 3 -- 3 145 11.2 1 0 2 2 3 3 1 3 0 -- 3 146 11.2 3 1 3 3 3 3 2 3 3 -- 3 147 11.2 1 0 1 3 3 3 0 3 1 3 3 148 11.2 0 0 2 0 3 2 1 0 0 1 3 149 11.2 3 1 3 3 3 3 0 3 3 3 3 150 11.2 3 0 0 2 3 0 0 3 3 1 3 151 11.2 3 0 3 3 3 3 1 0 0 2 3 152 11.2 3 0 3 3 3 3 0 3 0 -- 3 153 11.2 2 0 3 3 3 3 0 0 0 2 3 154 11.2 3 2 3 3 3 3 3 3 3 3 3 155 11.2 3 0 1 3 3 2 0 0 0 0 3 156 11.2 3 3 3 3 3 3 2 3 3 3 3 157 11.2 3 0 3 3 3 3 1 3 1 3 3 158 11.2 0 0 3 3 3 3 0 3 0 3 3 159 11.2 0 0 0 0 3 1 0 3 1 3 3 160 11.2 0 0 0 0 0 0 0 1 0 0 3 161 11.2 3 0 3 3 3 3 0 0 0 -- 3 162 11.2 0 0 1 2 3 3 0 0 0 3 3 163 11.2 1 0 1 1 3 3 0 0 0 3 3 164 11.2 3 0 3 3 3 3 0 3 0 3 3 165 11.2 1 0 3 3 3 3 1 3 0 3 3 166 11.2 3 0 1 1 3 3 0 3 0 3 3 167 11.2 3 0 2 3 3 3 1 3 0 1 3 168 11.2 3 1 3 3 3 3 2 3 1 3 3 169 11.2 1 0 3 3 3 3 0 0 0 1 3 170 11.2 3 3 3 3 3 3 3 3 3 3 3 171 11.2 3 2 3 3 3 3 2 3 3 3 3 172 11.2 3 2 3 3 3 3 1 3 1 3 3 173 11.2 3 2 3 3 3 3 3 3 2 3 3 174 11.2 0 0 1 0 2 0 0 0 0 0 3 175 11.2 1 0 3 3 3 3 0 1 0 3 3 176 11.2 0 0 3 3 3 3 0 3 0 3 3 177 11.2 0 0 0 0 3 1 0 2 0 0 3 178 11.2 3 2 3 3 3 3 3 3 3 3 3 179 11.2 1 0 0 0 3 1 0 0 0 0 3 180 11.2 3 1 3 3 3 3 0 3 3 3 3 181 11.2 0 0 0 2 2 1 0 1 3 0 3 182 11.2 0 0 0 0 3 3 0 0 0 1 3 183 11.2 1 0 3 3 3 3 0 3 0 3 3 184 11.2 0 0 2 1 3 3 0 1 0 3 3 185 11.2 0 0 2 1 3 3 0 0 0 3 3 186 11.2 0 0 0 0 0 0 0 0 0 0 3 187 11.2 1 0 2 3 3 3 0 3 0 3 3 188 11.2 2 1 3 3 3 3 1 3 0 3 3 189 11.2 0 0 0 0 0 0 0 0 0 0 0 190 11.2 3 1 3 3 3 3 1 3 3 3 3 191 11.2 3 3 3 3 3 3 3 3 3 N 3 192 11.2 0 0 2 3 3 1 0 1 0 N 3 193 11.2 0 0 1 0 0 0 0 0 0 N 3 194 11.2 3 1 3 3 3 3 2 3 3 3 3 195 11.2 0 0 0 1 2 0 0 0 3 1 3 196 11.2 3 3 3 3 3 3 3 3 3 3 3 197 11.2 0 0 0 0 2 0 0 0 N 0 3 198 11.2 1 1 2 3 3 3 0 0 0 3 3 199 11.2 3 2 3 3 3 3 3 3 2 3 3 200 11.2 3 0 3 3 3 3 2 3 3 3 3 201 11.2 0 0 3 3 3 3 1 3 3 3 3 202 11.2 3 0 3 3 3 3 1 3 3 3 3 203 11.2 0 0 3 3 3 3 0 0 3 1 3 204 11.2 3 0 3 3 3 3 1 3 3 3 3 205 11.2 3 3 3 3 3 3 1 3 3 3 3 206 11.2 3 2 3 3 3 3 1 3 3 3 3 207 11.2 3 0 3 3 3 3 0 3 3 3 3 208 11.2 3 0 3 3 3 3 1 3 3 3 3______________________________________ CROP AND WEED PLANT HERBICIDE ACTIVITY The compounds were further tested by utilizing the above procedure on the following plant species, i.e., on weeds in the presence of crop plants. ______________________________________L - Soybean R - Hemp SesbaniaM - Sugarbeet E - Common LambsquartersN - Wheat F - Pennsylvania SmartweedO - Rice C - VelvetleafP - Grain Sorghum J - Downy BromeB - Cocklebur S - Panicum spp.Q - Wild Buckwheat K - BarnyardgrassD - Morningglory T - Large Crabgrass______________________________________ The results are summarized in table 3. TABLE 3__________________________________________________________________________PRE-EMERGENT ACTIVITY FOR WEEDS IN CROP PLANTSExample No. Kg/ha L M N O P B Q D R E F C J S K T__________________________________________________________________________ 1 5.6 0 3 0 0 2 0 0 1 1 3 3 1 1 2 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 5.6 0 3 2 2 3 0 3 3 2 3 3 2 3 3 3 3 1.12 0 1 0 0 0 0 0 0 0 0 0 0 0 1 1 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 5.6 2 3 0 3 3 0 3 3 3 3 2 3 3 3 3 3 1.12 0 2 0 0 2 0 2 0 0 1 1 1 1 3 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 4 5.6 0 1 0 0 2 0 0 0 1 0 0 0 2 2 2 2 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 5.6 1 3 1 3 3 0 2 2 2 3 2 2 3 3 3 3 1.12 0 1 0 0 0 0 0 2 2 2 1 1 1 2 3 3 0.28 0 0 0 0 0 N 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 N 0 0 0 0 0 0 0 0 0 0 6 5.6 0 3 1 1 3 N 3 3 3 3 3 2 3 3 3 3 1.12 0 0 0 0 0 N 0 0 0 2 1 1 1 0 0 3 0.28 0 0 0 0 0 N 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 N 0 0 0 0 0 0 0 0 0 0 7 5.6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 5.6 0 0 1 1 3 0 0 0 0 0 0 0 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 9 5.6 1 3 3 2 3 0 3 3 3 3 3 3 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 1 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 010 5.6 1 3 3 3 3 0 2 1 2 3 1 1 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 2 0.28 0 0 0 0 0 N 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 011 5.6 0 2 1 3 3 0 0 2 1 1 1 1 1 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 012 5.6 1 3 2 3 3 0 3 3 2 3 3 1 3 3 3 3 1.12 0 2 1 0 3 0 2 2 1 2 2 1 3 3 2 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 013 5.6 0 1 3 3 3 1 3 3 3 3 3 2 3 3 3 3 1.12 0 1 0 1 2 0 0 0 1 1 1 0 0 2 1 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 014 5.6 2 3 3 3 3 0 3 3 3 3 3 3 3 3 3 3 1.12 0 1 0 0 1 0 0 0 0 2 2 0 0 3 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 015 5.6 3 3 2 3 3 0 3 3 3 3 3 2 3 3 3 3 1.12 0 2 0 3 3 0 1 3 2 3 1 0 2 3 3 3 0.28 0 1 0 0 2 0 0 1 2 1 0 0 0 0 1 2 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 016 5.6 0 2 0 0 3 0 2 2 2 3 3 2 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 2 2 1 0 0 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 017 5.6 3 3 3 3 3 0 3 3 3 3 3 3 N 3 3 3 1.12 0 2 3 1 3 0 2 1 2 2 2 1 N 3 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 N 0 0 3 0.056 0 0 0 0 0 0 0 0 0 0 0 0 N 0 0 119 5.6 0 2 1 1 2 0 0 0 0 1 2 0 2 2 3 3 1.12 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 027 5.6 0 3 0 0 0 0 0 2 0 3 3 3 0 0 0 0 1.12 0 0 0 0 0 0 0 3 0 2 2 2 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 028 5.6 0 3 0 0 0 0 0 0 0 1 1 0 0 0 2 0 1.12 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 029 5.6 0 1 0 0 1 0 0 0 0 2 1 0 1 2 3 2 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 031 5.6 0 0 1 1 0 0 0 0 0 1 2 0 N 0 3 2 1.12 0 0 0 0 0 0 0 0 0 0 1 0 N 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 1 0 N 0 1 032 5.6 1 3 2 1 3 0 3 3 2 3 3 1 3 3 3 3 1.12 0 1 0 0 2 0 0 0 0 0 0 0 2 2 1 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 033 5.6 2 3 3 3 3 0 2 3 3 3 3 3 3 3 3 3 1.12 0 1 1 0 2 0 0 0 1 1 2 0 2 2 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 3 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 234 5.6 1 3 3 2 3 0 3 3 3 3 3 3 3 3 3 3 1.12 0 3 3 1 3 0 1 2 2 2 2 2 2 3 3 3 0.28 0 1 1 0 0 0 0 0 0 0 0 0 2 0 1 3 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 135 5.6 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 1.12 1 3 3 2 3 0 2 0 3 3 3 3 3 3 3 3 0.28 0 2 0 1 1 0 1 0 1 1 1 0 2 1 3 3 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 236 5.6 2 3 3 2 3 0 3 3 3 3 3 3 3 3 3 3 1.12 0 1 0 0 3 0 0 0 1 2 1 1 0 3 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 N 0 0 0 0 0 1 0 0 0 037 5.6 0 3 3 1 3 0 2 3 1 2 2 2 3 3 3 3 1.12 0 0 0 0 2 0 0 0 0 1 0 0 0 2 3 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 038 5.6 2 3 3 3 3 0 3 3 3 3 3 3 3 3 3 3 1.12 1 3 3 1 3 0 3 2 1 3 3 0 3 3 3 3 0.28 0 2 1 0 0 0 0 0 0 0 0 0 0 0 3 3 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 339 5.6 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 1.12 0 2 3 3 3 0 2 2 2 3 3 2 3 3 3 3 0.28 0 1 0 1 2 0 0 1 0 2 0 1 1 2 3 3 0.056 0 0 2 0 2 0 1 0 0 0 0 0 1 1 3 3 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 040 5.6 2 3 3 2 3 0 2 2 2 1 2 1 3 3 3 3 1.12 0 0 1 0 3 0 0 0 0 1 0 0 2 2 3 3 0.28 0 0 0 0 0 0 1 0 0 0 0 0 0 0 2 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 041 5.6 0 0 1 1 1 0 0 1 0 0 1 1 0 0 2 2 1.12 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 142 5.6 0 0 0 1 1 0 0 1 0 3 2 0 0 0 2 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 043 5.6 0 3 1 0 3 0 2 0 0 0 1 0 3 0 3 3 1.12 0 0 0 0 0 0 2 0 0 0 0 0 1 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 044 5.6 0 1 0 0 0 0 0 0 0 1 1 0 1 0 2 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 045 5.6 0 2 1 1 1 0 0 1 2 3 2 2 N 3 3 3 1.12 0 0 0 0 0 0 0 0 0 2 1 2 N 1 0 3 0.28 0 0 0 0 0 0 0 0 0 1 0 1 N 0 0 246 5.6 0 3 0 0 0 0 0 0 0 3 0 0 0 0 0 2 1.12 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0.28 0 0 0 0 0 N 0 0 0 0 0 0 0 0 0 047 5.6 0 3 0 0 0 0 0 0 0 2 1 1 0 0 0 1 1.12 0 2 0 0 0 0 0 0 0 3 0 1 0 0 0 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 048 5.6 0 2 2 0 2 0 3 1 1 3 2 0 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 049 5.6 1 3 3 2 3 0 1 1 2 2 2 1 3 3 3 3 1.12 0 2 0 0 0 0 0 0 0 0 0 0 0 0 2 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 050 5.6 0 1 0 0 0 0 0 0 0 1 1 0 2 3 3 3 1.12 0 1 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0.28 0 1 0 0 0 0 2 0 0 0 0 0 0 0 0 052 5.6 0 2 0 0 3 0 1 0 0 2 2 1 3 3 3 3 1.12 0 2 1 0 0 0 0 0 0 1 0 0 0 0 2 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 153 5.6 0 1 1 2 3 0 0 0 0 0 1 0 2 2 3 3 1.12 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0.28 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 054 5.6 0 2 3 1 3 0 3 3 2 3 3 3 3 3 3 3 1.12 0 1 0 0 0 0 0 1 0 2 2 1 1 1 2 3 0.28 0 0 1 0 0 0 1 0 0 0 0 0 3 0 0 1 0.56 0 0 1 1 2 0 1 0 0 0 0 0 2 1 0 355 5.6 0 2 0 0 2 0 0 0 0 1 2 2 0 1 3 2 1.12 0 1 0 0 0 0 0 0 0 1 0 0 2 0 2 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 056 5.6 0 2 0 0 1 0 1 1 0 1 1 0 1 1 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 057 5.6 1 3 2 1 3 0 3 2 2 3 3 3 2 3 3 3 1.12 0 0 0 0 0 0 0 0 0 2 1 0 1 0 0 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 058 5.6 0 2 1 1 1 0 0 0 0 0 1 0 0 1 3 2 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 059 5.6 0 2 0 0 3 0 2 1 0 3 2 1 2 3 3 3 1.12 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 060 5.6 0 3 1 1 1 2 2 1 1 3 3 1 3 3 3 3 1.12 0 0 1 0 0 0 2 0 0 0 0 0 0 0 1 0 0.28 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 061 5.6 0 0 0 0 0 0 0 0 0 2 0 1 2 0 0 0 1.12 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 063 5.6 0 0 0 0 2 2 0 1 0 1 2 0 0 2 3 0 1.12 0 1 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 064 5.6 0 1 1 0 0 0 0 0 0 0 1 0 0 0 3 0 1.12 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0.28 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 065 5.6 0 1 0 0 0 0 1 0 0 2 1 0 0 0 0 0 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 068 5.6 1 3 2 1 3 1 3 2 2 3 3 2 3 3 3 3 1.12 0 0 0 0 0 0 2 0 1 2 2 1 1 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 069 5.6 0 1 0 0 1 0 1 2 1 2 0 0 1 3 3 3 1.12 0 1 0 0 0 0 0 0 0 0 0 0 2 0 0 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 071 5.6 0 3 0 3 2 N 2 2 3 3 3 2 2 3 3 3 1.12 0 1 0 0 0 0 0 0 0 0 0 0 0 1 2 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 072 5.6 3 3 3 1 3 0 3 3 3 3 3 3 3 3 3 3 1.12 0 1 1 0 2 0 0 0 0 1 2 1 1 1 2 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 073 5.6 0 0 1 0 0 0 0 0 0 1 1 0 0 0 1 2 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 074 5.6 0 3 3 3 3 0 3 2 2 3 3 1 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 075 5.6 2 3 2 3 3 0 3 3 3 3 3 2 3 3 3 3 1.12 0 0 0 1 0 0 0 0 0 0 0 0 1 2 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 076 5.6 0 3 2 2 0 0 1 2 2 2 2 0 1 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.056 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 077 5.6 2 3 1 2 3 0 0 3 2 3 3 0 3 3 3 3 1.12 0 1 0 1 0 0 3 0 1 1 1 0 1 1 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 078 5.6 1 3 1 3 3 1 3 3 3 3 3 3 3 3 3 3 1.12 0 2 0 1 0 0 0 0 1 3 3 0 1 1 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 3 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 079 5.6 0 2 1 1 1 3 0 2 2 1 1 0 1 2 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 080 5.6 0 3 1 2 3 0 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5.6 0 3 0 1 0 0 1 0 0 3 1 0 1 1 0 3 1.12 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 2 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0170 5.6 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 1.12 3 3 3 3 3 2 3 3 3 3 3 3 3 3 3 3 0.28 1 3 3 3 3 0 3 3 3 3 3 3 3 3 3 3 0.056 0 3 2 3 3 0 3 0 3 3 3 3 3 3 3 3 0.0112 0 2 0 0 1 0 1 0 0 3 2 1 0 1 3 3171 5.6 3 3 3 3 3 2 3 3 3 3 3 3 3 3 3 3 1.12 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 0.28 0 2 3 3 3 0 2 2 2 3 3 2 3 3 3 3 0.056 0 0 1 1 3 0 0 0 0 2 2 0 2 3 3 3 0.0112 0 0 0 0 0 0 0 0 0 1 0 0 0 0 2 3172 5.6 3 3 3 3 3 2 3 3 3 3 3 3 3 3 3 3 1.12 3 3 3 3 3 0 3 3 3 3 3 3 3 3 3 3 0.28 0 2 2 2 3 0 2 0 1 3 3 1 3 3 3 3 0.056 0 0 0 1 0 0 1 0 0 0 0 0 2 2 2 3 0.0112 0 0 0 0 0 0 0 0 1 1 1 1 1 0 0 0173 5.6 3 3 3 3 3 1 3 3 3 3 3 2 3 3 3 3 1.12 0 3 1 1 3 0 3 3 3 3 3 1 3 3 3 3 0.28 0 2 0 0 3 0 0 1 2 2 3 0 3 3 3 3 0.056 0 1 0 0 0 0 0 0 1 0 1 0 1 2 3 2 0.0112 0 0 0 0 0 0 0 N 0 0 1 0 0 0 0 0174 5.6 0 2 0 1 0 0 0 0 0 3 1 0 3 0 0 2 1.12 0 0 0 0 0 0 0 0 0 1 0 0 2 0 0 1175 5.6 0 3 1 1 3 0 0 1 1 2 3 1 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 1 0 2 1 3 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0176 5.6 1 3 3 3 3 0 3 2 3 3 3 2 3 3 3 3 1.12 0 3 2 1 3 0 2 0 1 3 2 0 3 3 3 3 0.28 0 1 0 0 0 0 0 0 0 0 0 0 3 0 2 2 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0177 5.6 2 3 1 1 0 0 2 0 1 3 2 1 3 1 3 3 1.12 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1178 5.6 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 1.12 3 3 3 3 3 0 3 3 3 3 3 2 3 3 3 3 0.28 0 3 1 1 3 0 3 2 2 3 3 0 3 3 3 3 0.056 0 0 0 0 0 0 3 0 0 0 0 0 3 3 3 3 0.0112 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 2179 5.6 0 3 0 0 0 0 0 0 0 2 1 0 2 1 2 2 1.12 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0180 5.6 3 3 3 3 3 2 3 3 3 3 3 3 3 3 3 3 1.12 0 2 2 2 2 0 2 2 2 3 3 2 2 3 3 3 0.56 0 0 2 0 1 0 1 1 0 2 3 0 2 3 3 3 0.28 0 0 1 0 1 0 0 0 0 0 2 0 2 3 3 3 0.14 0 0 0 0 0 0 0 0 0 0 1 0 1 1 3 3 0.07 0 1 1 0 0 0 0 0 0 1 0 0 1 0 1 1 0.035 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0182 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0818 5.6 0 3 0 0 0 0 2 0 0 2 2 0 1 1 3 2 1.12 0 2 0 0 0 0 0 0 0 2 2 0 0 0 0 0 0.56 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0182 5.6 0 1 0 1 3 0 1 1 1 2 2 0 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 1 0 0 0 2 3 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1183 5.6 1 3 3 3 3 0 3 2 3 3 3 1 3 3 3 3 1.12 0 0 2 1 3 0 0 1 1 2 1 N 1 3 3 3 0.28 1 0 0 0 1 0 0 0 0 0 1 0 0 0 3 2 0.056 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1184 5.6 1 0 1 0 2 0 0 0 0 0 2 0 2 3 3 3 1.12 0 0 1 0 0 0 0 0 0 0 1 0 0 0 1 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1185 5.6 0 1 0 1 3 0 1 1 1 0 2 0 3 3 3 3 1.12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1186 5.6 0 3 0 1 0 1 0 2 2 2 2 1 1 0 1 3 1.12 0 2 0 0 0 0 0 0 1 2 2 1 0 0 0 1188 5.6 3 3 3 3 3 0 3 3 3 3 3 3 3 3 3 3 1.12 0 3 2 2 2 0 2 2 3 2 3 3 2 3 3 3 0.56 0 3 1 1 2 0 2 2 2 2 3 2 2 3 3 3 0.28 0 2 0 1 1 0 1 1 2 1 3 0 1 3 3 3 0.14 0 1 0 0 1 0 0 0 0 0 2 0 0 2 3 3 0.07 0 1 0 0 0 0 0 0 0 0 1 0 0 0 1 2190 5.6 1 3 1 2 2 1 3 2 2 3 3 2 3 3 3 3 1.12 1 3 1 1 1 1 2 1 0 3 2 1 3 2 3 3 0.56 0 0 1 0 1 0 2 0 0 1 1 0 2 1 1 2 0.28 0 1 1 1 0 0 2 0 0 0 0 0 0 0 0 0 0.14 0 1 0 0 0 0 2 0 0 0 0 0 0 0 0 1 0.07 0 1 0 0 0 0 2 0 0 1 0 0 2 0 0 1 0.035 0 1 2 1 0 0 1 0 0 1 1 0 1 0 0 0191 5.6 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 1.12 1 3 3 3 3 0 3 2 2 3 3 3 3 3 3 3 0.56 0 3 3 3 3 0 2 1 2 3 3 2 3 3 3 3 0.28 0 1 2 2 3 0 1 0 1 2 2 0 3 3 3 3 0.14 0 1 1 1 3 0 1 0 0 0 2 0 2 2 3 2 0.07 0 0 0 1 1 0 0 0 0 0 1 0 3 3 3 1 0.035 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 0.0182 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.009 0 0 0 0 0 0 0 0 0 0 0 N 0 0 0 0192 5.6 0 2 1 0 3 0 2 2 1 3 3 3 3 3 3 3 1.12 0 1 0 0 0 0 0 0 1 3 1 0 0 1 3 3 0.56 0 1 0 0 0 0 0 0 0 1 2 1 1 0 0 1 0.28 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0.14 0 0 0 0 0 0 1 0 0 2 0 0 1 0 0 0193 5.6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1.12 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.56 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0__________________________________________________________________________ POST-EMERGENT HERBICIDE EXAMPLES The post-emergence herbioidal activity of some of the various compounds of this invention was demonstrated by greenhouse testing in the following manner. Top soil is placed in aluminum pans having holes in the bottom and compacted to a depth of 0.95 to 1.27 cm. from the top of the pan. A predetermined number of seeds of each of several dicotyledonous and monocotyledonous annual plant species and/or vegetative propagules for the perennial plant species were placed on the soil and pressed into the soil surface. The seeds and/or vegetative propagules are covered with soil and leveled. The pans are then placed on a bench in the greenhouse and watered from below as needed. After the plants reach the desired age (two to three weeks), each pan, is removed individually to a spraying chamber and sprayed by means of an atomizer, operating at a spray pressure of 170.3 kPa (10 psig) at the application rates noted. In the spray solution is an amount of an emulsifying agent mixture to give a spray solution or suspension which contains about 0.4% by volume of the emulsifier. The spray solution or suspension contains a sufficient amount of the candidate chemical in order to give application rates of the active ingredient corresponding to those shown in the Tables while applying a total amount of solution or suspension equivalent to 1870 L/Ha (200 gallons/acre). The pans were returned to the greenhouse and watered as before and the injury to the plants as compared to the control is observed at approximately 10-14 days (usually 11 days) and in some instances observed again at 24-28 days (usually 25 days) after spraying. These latter observations are designated by an asterisk (*) following the column of example numbers in the Table. The post-emergent herbicidal activity index used in Table 4 is as follows: ______________________________________Plant Response Index______________________________________0-24% inhibition 025-49% inhibition 150-74% inhibition 275-99% inhibition 3100% inhibition 4Species not planted --Species planted, no data N______________________________________ TABLE 4______________________________________POST-EMERGENT ACTIVITY FOR WEEDSExample No. Kg/ha A B C D E F G H I J K______________________________________ 1 11.2 0 0 0 0 0 0 0 0 0 0 0 2 11.2 0 0 0 0 0 0 0 0 0 0 0 3 11.2 0 0 0 0 0 0 0 0 -- 0 0 4 11.2 0 0 0 0 0 0 1 0 -- 0 1 5 11.2 0 N 0 1 0 0 0 0 0 0 0 6 11.2 0 0 0 0 0 0 0 0 -- 0 0 7 11.2 N 3 1 3 4 1 0 0 0 0 2 7* 11.2 N 4 1 3 4 1 0 0 0 0 1 7* 11.2 N 3 1 3 3 0 0 0 0 0 1 8 11.2 0 0 0 0 0 0 0 0 0 0 0 9 11.2 0 0 0 0 0 0 0 0 0 0 0 10 11.2 N 0 1 0 0 0 0 0 0 0 0 11 11.2 0 N 0 0 0 0 0 0 0 0 0 12 11.2 0 0 0 0 0 0 0 0 -- 0 0 13 11.2 0 N 0 0 0 0 0 0 0 0 0 14 11.2 0 0 0 0 0 0 0 0 N 0 0 15 11.2 0 N 0 0 0 0 0 0 0 0 0 16 11.2 0 0 0 0 0 0 0 0 N 0 0 17 11.2 -- 0 1 1 N 0 0 0 0 0 1 18 11.2 -- 0 0 0 0 0 0 1 0 0 1 19 11.2 -- 0 0 0 0 0 0 0 1 0 0 20 11.2 -- 0 0 0 0 0 0 0 0 0 0 21 11.2 -- 0 0 0 0 0 0 0 0 0 0 22 11.2 -- 0 0 0 0 0 0 0 0 0 0 23 11.2 -- 0 0 0 0 0 0 0 0 0 0 24 11.2 -- 0 0 0 0 0 0 0 0 0 0 25 11.2 N 0 0 1 1 0 1 1 0 0 1 26 11.2 -- 0 1 3 3 0 1 0 0 0 1 26* 11.2 -- 1 0 3 3 0 0 0 0 0 1 27 11.2 -- 1 1 1 1 0 1 0 0 0 1 28 11.2 -- 1 0 1 3 0 0 0 0 0 0 29 11.2 -- 0 0 0 0 0 0 0 0 0 0 30 11.2 -- 0 0 1 N 0 0 0 0 0 0 31 11.2 -- 0 0 1 0 0 0 0 0 0 1 32 11.2 -- 0 0 0 0 0 0 0 2 0 1 33 11.2 -- 0 0 0 0 0 0 0 0 0 0 34 11.2 -- 0 0 0 0 0 0 0 0 0 0 35 11.2 -- 1 0 0 0 0 0 0 0 0 0 36 11.2 -- 0 0 0 0 0 0 0 0 0 0 37 11.2 -- 0 0 0 0 0 0 0 0 0 0 38 11.2 -- 0 0 0 0 0 0 0 0 0 0 39 11.2 -- 0 0 0 0 0 0 0 0 0 0 40 11.2 -- 0 0 0 0 0 0 0 N 0 0 41 11.2 -- 0 0 0 0 0 0 0 0 0 0 42 11.2 -- 0 0 0 0 0 0 0 0 0 0 43 11.2 -- 0 0 0 0 0 0 0 N 0 0 44 11.2 -- 0 0 0 0 0 0 0 N 0 0 45 11.2 -- 0 0 1 1 0 0 0 0 0 0 46 11.2 -- 0 0 0 0 0 0 0 0 0 0 47 11.2 -- 0 0 0 2 0 0 0 0 0 1 48 11.2 -- 0 0 0 0 0 0 0 0 0 0 49 11.2 -- 0 0 0 0 0 0 0 0 0 0 50 11.2 -- 0 0 0 0 0 0 0 0 0 0 51 11.2 -- 1 0 0 0 0 0 0 0 0 0 52 11.2 -- 0 0 0 0 0 0 0 0 0 0 53 11.2 -- 0 0 0 0 0 0 0 N 0 0 54 11.2 -- 0 0 0 0 0 0 0 0 0 0 55 11.2 -- 0 0 0 0 0 0 0 0 0 0 56 11.2 -- 0 0 0 0 0 0 0 0 0 0 57 11.2 -- 0 0 0 0 0 0 0 0 0 0 58 11.2 -- 0 0 0 1 0 0 0 0 0 1 59 11.2 -- 0 0 0 0 0 0 0 0 0 0 60 11.2 -- 0 0 0 0 0 0 0 0 0 0 61 11.2 -- 0 0 0 0 0 0 0 0 0 0 62 11.2 -- 0 0 0 0 0 0 0 0 0 0 63 11.2 -- 0 0 0 0 0 0 0 0 0 0 64 11.2 -- 0 0 0 0 0 0 0 0 0 0 65 11.2 -- 0 0 0 0 0 0 0 0 0 0 66 11.2 -- 0 0 0 0 0 0 0 N 0 0 67 11.2 -- 1 0 0 0 0 0 0 0 0 0 68 11.2 -- 0 0 0 0 0 0 0 0 0 0 69 11.2 -- 0 0 0 0 0 0 0 0 0 0 70 11.2 -- 0 0 0 0 0 0 0 0 0 0 71 11.2 0 1 1 1 1 0 0 0 0 0 0 72 11.2 0 0 0 0 0 0 0 0 N 0 0 73 11.2 N 0 0 0 0 0 0 0 0 0 0 74 11.2 N 0 0 0 0 0 0 0 0 0 0 75 11.2 0 0 0 0 0 0 0 0 0 0 0 76 11.2 0 0 0 0 0 0 0 0 0 0 0 77 11.2 0 0 0 0 0 0 0 0 0 0 0 78 11.2 0 0 0 0 0 0 0 0 0 0 0 79 11.2 0 0 0 0 0 0 0 0 0 0 0 80 11.2 0 0 0 0 0 0 0 0 0 0 0 81 11.2 -- 0 0 0 0 0 0 0 0 0 0 82 11.2 -- 0 0 0 0 0 0 0 0 0 0 83 11.2 -- 0 0 0 0 0 0 0 0 0 0 84 11.2 -- 0 0 0 0 0 0 0 0 0 0 85 11.2 -- 0 0 0 0 0 0 0 0 0 0 86 11.2 -- 0 0 0 0 0 0 0 0 0 0 87 11.2 -- 0 0 0 0 0 0 0 0 0 0 88 11.2 -- 0 1 0 0 0 0 0 N 0 0 89 11.2 -- 0 0 0 0 0 0 0 N 0 0 90 11.2 -- 0 1 0 0 0 0 0 N 0 0 91 11.2 -- 0 0 0 0 0 0 0 N 0 0 92 11.2 -- 0 0 0 0 0 0 0 N 0 0 93 11.2 -- 0 0 0 0 0 0 0 0 0 1 94 11.2 -- 0 1 0 0 0 0 0 N 0 0 95 11.2 -- 0 1 0 0 0 0 1 0 0 0 96 11.2 -- 0 1 1 0 0 0 0 0 0 0 97 11.2 -- 0 0 0 1 0 0 0 0 0 0 98 11.2 -- 0 0 1 0 0 0 0 0 0 0 99 11.2 -- 0 1 1 0 0 0 1 0 0 0 100 11.2 -- 0 1 1 0 0 0 0 0 0 0 101 11.2 -- 0 0 N 0 0 0 0 0 0 1 102 11.2 -- 1 0 0 0 0 0 0 0 0 1 103 11.2 0 0 0 1 0 0 0 0 0 0 0 104 11.2 0 0 0 0 0 0 0 0 0 0 0 105 11.2 0 0 1 1 0 0 0 0 0 0 0 106 11.2 0 1 1 1 0 0 0 0 0 0 1 107 11.2 1 1 0 1 4 0 1 0 0 0 1 107* 11.2 2 1 1 2 4 0 1 0 0 0 1 108 11.2 0 1 1 1 3 0 0 0 0 0 1 109 11.2 0 0 0 0 1 0 0 1 0 0 1 110 11.2 0 0 0 0 0 0 0 0 0 0 0 111 11.2 0 0 0 0 1 0 0 0 0 0 0 112 11.2 0 1 1 0 1 0 0 0 0 0 1 113 11.2 1 1 1 1 0 0 0 0 0 0 0 114 11.2 1 1 0 1 0 0 0 0 0 0 0 115 11.2 0 0 0 0 0 0 0 0 0 0 0 116 11.2 0 0 0 0 0 0 0 0 0 0 0 117 11.2 0 0 0 0 0 0 0 0 0 0 0 118 11.2 0 N 1 2 1 1 1 0 0 0 2 119 11.2 0 0 0 0 0 0 0 0 0 0 0 120 11.2 0 0 0 0 0 0 0 0 0 0 0 121 11.2 0 0 0 0 1 0 0 0 0 0 0 122 11.2 0 0 0 0 0 0 0 0 0 0 0 123 11.2 0 0 0 N 0 0 0 0 0 0 0 124 11.2 0 0 2 1 1 0 0 0 0 0 1 125 11.2 0 0 1 N 1 0 0 0 1 0 2 126 11.2 0 1 0 N 0 0 0 0 0 0 0 127 11.2 N 2 1 1 0 1 1 0 0 0 2 128 11.2 0 1 0 0 1 0 0 0 0 0 1 129 11.2 0 0 0 0 0 0 0 0 0 0 0 130 11.2 0 1 1 1 0 0 0 0 0 0 1 131 11.2 0 0 0 0 0 0 0 0 0 0 0 132 11.2 0 0 0 0 0 0 0 0 0 0 0 133 11.2 0 0 0 0 0 0 0 0 0 0 0 134 11.2 0 0 0 0 0 0 0 0 0 0 0 135 11.2 N 3 2 3 3 1 1 3 1 0 2 135* 11.2 N 3 2 3 3 2 0 3 1 0 1 136 11.2 4 0 0 2 3 0 0 0 0 -- 0 137 11.2 N 0 0 0 0 0 0 0 0 0 0 138 11.2 0 0 0 0 4 0 0 0 0 -- 0 139 11.2 0 0 0 0 0 0 0 0 0 0 0 140 11.2 0 0 0 0 0 0 0 0 N 0 0 141 11.2 N 0 0 0 0 0 0 0 N 0 0 142 11.2 0 0 0 1 0 0 0 0 0 0 0 143 11.2 0 1 1 1 0 0 0 0 N 0 0 144 11.2 0 0 0 0 0 0 0 0 0 0 0 145 11.2 0 0 0 0 2 0 0 0 0 0 0 146 11.2 0 0 0 0 0 0 0 0 N 0 1 147 11.2 0 0 0 0 0 0 0 0 0 0 0 148 11.2 0 0 1 0 1 0 0 0 0 0 0 149 11.2 0 0 0 0 1 0 0 0 0 0 0 150 11.2 0 0 0 0 0 0 0 0 0 0 0 151 11.2 0 0 0 1 0 0 0 0 0 0 0 152 11.2 0 0 1 1 0 0 0 0 N 0 0 153 11.2 0 0 0 0 0 0 0 0 0 0 0 154 11.2 0 0 0 0 0 0 0 N 0 0 0 155 11.2 0 0 1 1 0 0 0 0 0 0 0 155 11.2 N 0 1 0 0 0 0 0 0 0 1 157 11.2 1 0 1 0 0 0 0 0 0 0 0 158 11.2 0 0 0 0 0 0 0 0 0 0 0 159 11.2 0 0 0 0 0 0 0 0 0 0 0 160 11.2 0 0 0 0 0 0 0 0 0 0 1 161 11.2 0 0 0 0 0 0 0 0 N 0 0 162 11.2 0 0 0 0 0 0 0 0 0 0 0 163 11.2 0 0 0 0 0 0 0 0 0 0 0 164 11.2 N 0 0 0 0 0 0 0 1 0 0 165 11.2 0 0 1 0 0 0 0 0 0 1 0 166 11.2 0 0 0 0 0 0 0 0 0 0 0 167 11.2 1 1 1 1 2 0 0 0 0 0 1 168 11.2 0 0 1 1 0 0 0 0 0 0 0 169 11.2 N 0 1 0 0 0 0 0 0 0 0 170 11.2 1 1 1 1 0 0 0 0 0 0 1 171 11.2 N 0 0 0 0 0 0 0 0 0 1 172 11.2 N 0 0 0 0 0 0 0 0 0 0 173 11.2 0 0 1 0 0 0 0 0 0 0 0 174 11.2 0 0 0 0 0 0 0 0 0 0 0 175 11.2 0 0 0 0 0 0 0 0 0 0 0 176 11.2 0 0 1 0 N 0 0 0 0 0 0 177 11.2 0 0 0 0 0 0 0 0 0 0 0 178 11.2 0 0 0 0 0 0 0 0 0 0 0 179 11.2 0 0 0 0 0 0 0 0 0 0 0 180 11.2 0 0 1 0 0 0 0 0 0 0 1 181 11.2 0 0 0 0 0 0 0 0 0 0 0 182 11.2 0 0 0 0 N 0 0 0 0 0 0 183 11.2 0 0 0 0 0 0 0 0 0 0 0 184 11.2 0 0 1 0 N 0 0 0 0 0 0 185 11.2 0 0 0 0 N 0 0 0 0 0 0 186 11.2 0 0 0 0 0 0 0 0 0 0 0 187 11.2 0 0 0 0 0 0 0 0 0 0 0 188 11.2 1 2 1 1 1 0 0 0 0 0 1 189 11.2 0 0 0 0 0 0 0 0 0 0 0 190 11.2 0 0 0 0 0 0 0 0 0 0 0 191 11.2 0 0 0 0 0 0 0 0 0 0 0 192 11.2 0 0 0 0 0 0 0 0 0 0 0 193 11.2 0 0 0 0 0 0 0 0 0 0 0 194 11.2 0 0 0 0 0 0 0 0 N 0 1 195 11.2 0 0 0 0 0 0 0 0 N 0 0 196 11.2 0 0 0 0 0 0 0 0 N 0 0 197 11.2 0 0 0 0 0 0 0 0 0 0 0 198 11.2 0 0 0 0 0 0 0 0 0 0 0 199 11.2 0 0 0 0 0 0 0 0 0 0 0 200 11.2 0 0 0 0 0 0 0 0 0 0 0 201 11.2 0 0 0 0 0 0 0 0 0 0 0 202 11.2 0 0 0 0 0 0 0 0 0 0 0 203 11.2 0 0 0 0 0 0 0 0 0 0 0 204 11.2 0 0 0 0 0 0 0 0 0 0 0 205 11.2 0 0 0 0 0 0 0 0 0 0 0 206 11.2 0 0 0 0 0 0 0 0 0 0 0 207 11.2 0 0 0 0 1 0 0 0 0 0 0 208 11.2 0 0 0 0 0 0 0 0 N 0 0______________________________________ As can be seen from the data above, some of the compounds appear to be quite safe on certain crops and can thus be used for selective control of weeds in these crops. The herbicidal compositions of this invention, including concentrates which require dilution prior to application, may contain at least one active ingredient and an adjuvant in liquid or solid form. The compositions are prepared by admixing the active ingredient with an adjuvant including diluents, extenders, carriers, and conditioning agents to provide compositions in the form of finely-divided particulate solids, granules, pellets, solutions, dispersions or emulsions. Thus, it is believed that the active ingredient could be used with an adjuvant such as a finely-divided solid, a liquid of organic origin, water, a wetting agent, a dispersing agent, an emulsifying agent or any suitable combination of these. Suitable wetting agents are believed to include alkyl benzene and alkyl naphthalene sulfonates, sulfated fatty alcohols, amines or acid amides, long chain acid esters of sodium isothionate, esters of sodium sulfosuccinate, sulfated or sulfonated fatty acid esters, petroleum sulfonates, sulfonated vegetable oils, ditertiary acetylenic glycols, polyoxyethylene derivatives of alkylphenols (particularly isooctylphenol and nonylphenol) and polyoxyethylene derivatives of the mono-higher fatty acid esters of hexitol anhydrides (e.g., sorbitan). Preferred dispersants are methyl, cellulose, polyvinyl alcohol, sodium lignin sulfonates, polymeric alkyl naphthalene sulfonates, sodium naphthalene sulfonate, and polymethylene bisnaphthalene sulfonate. Wettable powders are water-dispersible compositions containing one or more active ingredients, an inert solid extender and one or more wetting and dispersing agents. The inert solid extenders are usually of mineral origin such as the natural clays, diatomaceous earth and synthetic minerals derived from silica and the like. Examples of such extenders include kaolinites, attapulgite clay and synthetic magnesium silicate. The wettable powders compositions of this invention usually contain from above 0.5 to 60 parts (preferably from 5-20 parts) of active ingredient, from about 0.25 to 25 parts (preferably 1-15 parts) of wetting agent, from about 0.25 to 25 parts (preferably 1.0-15 parts of dispersant and from 5 to about 95 parts (preferably 5-50 parts) of inert solid extender, all parts being by weight of the total composition. Where required, from about 0.1 to 2.0 parts of the solid inert extender can be replaced by a corrosion inhibitor or anti-foaming agent or both. Other formulations include dust concentrates comprising from 0.1 to 60% by weight of the active ingredient on a suitable extender; these dusts may be diluted for application at concentrations within the range of from about 0.1-10% by weight. Aqueous suspensions or emulsions may be prepared by stirring a nonaqueous solution of a water-insoluble active ingredient and an emulsification agent with water until uniform and then homogenizing to give stable emulsion of very finely-divided particles. The resulting concentrated aqueous suspension is characterized by its extremely small particle size, so that when diluted and sprayed, coverage is very uniform. Suitable concentrations of these formulations contain from about 0.1-60% preferably 5-50% by weight of active ingredient, the upper limit being determined by the solubility limit of active ingredient in the solvent. Concentrates are usually solutions of active ingredient in water-immiscible or partially waterimmiscible solvents together with a surface active agent. Suitable solvents for the active ingredient of this invention include dimethylformamide, dimethylsulfoxide, N-methyl-pyrrolidone, hydrocarbons, and water-immiscible ethers, esters, or ketones. However, other high strength liquid concentrates may be formulated by dissolving the active ingredient in a solvent then diluting, e.g., with kerosene, to spray concentration. The concentrate compositions herein generally contain from about 0.1 to 95 parts (preferably 5-60 parts) active ingredient, about 0.25 to 50 parts (preferably 1-25 parts) surface active agent and where required about 4 to 94 parts solvent, all parts being by weight based on the total weight of emulsifiable oil. Granules are physically stable particulate compositions comprising active ingredient adhering to or distributed through a basic matrix of an inert, finely-divided particulate extender. In order to aid leaching of the active ingredient from the particulate, a surface active agent such as those listed hereinbefore can be present in the composition. Natural clays, pyrophyllites, illite, and vermiculite are examples of operable classes of particulate mineral extenders. The preferred extenders are the porous, absorptive, preformed particules such as preformed and screened particulate attapulgite or heat expanded, particulate vermiculite and the finely-divided clays such as kaolin clays, hydrated attapulgite or bentonitic clays. These extenders are sprayed or blended with the active ingredient to form the herbicidal granules. The granular compositions of this invention may contain from about 0.1 to about 30 parts by weight of active ingredient per 100 parts by weight of clay and 0 to about 5 parts by weight of surface active agent per 100 parts by weight of particulate clay. The compositions of this invention can also contain other additaments, for example, fertilizers, other herbicides, other pesticides, safeners and the like used as adjuvants or in combination with any of the above-described adjuvants. Chemicals useful in combination with the active ingredients of this invention included, for example, triazines, ureas, carbamates, acetamides, acetanilides, uracils, acetic acid or phenol derivatives, thiolcarbamates, triazoles, benzoic acids, nitriles, biphenyl ethers and the like such as: Heterocyclic Nitrogen/Sulfur Derivatives 2-Chloro-4-ethylamino-6-isopropylamino-s-triazine 2-Chloro-4,6-bis(isopropylamino)-s-triazine 2-Chloro-4,6-bis(ethylamino)-s-triazine 3-Isopropyl-1H-2,1,3-benzothiadiazin-4-(3H)-one 2,2 dioxide 3-Amino-1,2,4-triazole 6,7-Dihydrodipyrido(1,2-α:2',1'-c)-pyrazidiinium salt 5-Bromo-3-isopropyl-6-methyluracil 1,1'-Dimethyl-4,4'-bipyridinium 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-3-quinolinecarboxylic acid Isopropylamine salt of 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl) nicotinic acid Methyl 6-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-m-toluate and methyl 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl) -p-toluate Ureas N-(4-chlorophenoxy phenyl-N,N-dimethylurea N,N-dimethyl-N'-(3-chloro-4-methylphenyl) urea 3-(3,4-dichlorophenyl)-1,1-dimethylurea 1,3-Dimethyl-3-(2-benzothiazolyl) urea 3-(p-Chlorophenyl)-1,1-dimethyurea 1-Butyl-3-(3,4-dichlorophenyl)-1-methylurea 2-Chloro-N[(4-methoxy-6-methyl-3,5-triazin-2-yl) aminocarbonyl]-benzenesulfonamide Methyl 2-(((((4,6-dimethyl-2-pyrimidinyl)amino)-carbonyl)amino)sulfonyl) benzoate Ethyl 2-[methyl 2-(((((4,6-dimethyl-2-pyrimidinyl)-amino)carbonyl)amino)sulfonyl)]benzoate Methyl-2((4,6-dimethoxy pyrimidin-2-yl)amino-carbonyl)amino sulfonyl methyl) benzoate Methyl 2-(((((4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino)carbonyl)amino)sulfonyl) benzoate Carbamates/Thiolcarbamates 2-Chloroallyl diethyldithiocarbamate S-(4-chlorobenzyl)N,N-diethylthiolcarbamate Isopropyl N-(3-chlorophenyl) carbamate S-2,3-dichloroallyl N,N-diisopropylthiolcarbamate S-N,N-dipropylthiolcarbamate S-propyl N,N-dipropylthiolcarbamate S-2,3,3-trichloroallyl N,N-diisopropylthiolcarbamate Acetamides/Acetanilides/Anilines/Amides 2-Chloro-N,N-diallylacetamide N,N-dimethyl-2,2-diphenylacetamide N-(2,4-dimethyl-5-[(trifluoromethyl)sulfonyl]amino]-phenyl]acetamide N-Isopropyl-2-chloroacetanilide 2',6'-Diethyl-N-methoxymethyl-2-chloroacetanilide 2'-Methyl-6'-ethyl-N-(2-methoxyprop-2-yl)-2-chloroacetanilide α,α,α-Trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine N-(1,1-dimethylpropynyl)-3,5-dichlorobenzamide Acids/Esters/Alcohols 2,2-Dichloropropionic acid 2-Methyl-4-chlorophenoxyacetic acid 2,4-Dichlorophenoxyacetic acid Methyl-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate 3-Amino-2,5-dichlorobenzoic acid 2-Methoxy-3,6-dichlorobenzoic acid 2,3,6-Trichlorophenylacetic acid N-1-naphthylphthalamic acid Sodium 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate 4,6-Dinitro-o-sec-butylphenol N-(phosphonomethyl) glycine and its salts. Butyl 2-[4-[(5-(trifluoromethyl)-2-pyridinyl)oxy]-phenoxy]-propanoate Ethers 2,4-Dichlorophenyl-4-nitrophenyl ether 2-Chloro-α,α,α-trifluoro-p-tolyl-3-ethoxy-4-nitrodiphenyl ether 5-(2-chloro-4-trifluoromethylphenoxy)-N-methylsulfonyl 2-nitrobenzamide 1'-(Carboethoxy) ethyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate Miscellaneous 2,6-Dichlorobenzonitrile Monosodium acid methanearsonate Disodium methanearsonate 2-(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinon 7-oxabicyclo (2.2.1) heptane, 1-methyl-4-(1-methyl ethyl)-2-(2-methylphenylmethoxy)-,exo-. Fertilizer useful in combination with the active ingredients include, for example ammonium nitrate, urea, potash and superphosphate. Other useful additaments include materials in which plant organisms take root and grow such as compost, manure, humus, sand and the like. Herbicidal formulations of the types described above are exemplified in several illustrative embodiments below. ______________________________________ Weight Percent______________________________________I. Emulsifiable ConcentratesA. Compound of Example No. 3 11.0Free acid of complex organic 5.59phosphate or aromatic oraliphatic hydrophobe base(e.g., GAFAC RE-610, registeredtrademark of GAF Corp.)Polyoxyethylene/polyoxypropylene 1.11block copolymer with butanol(e.g., Tergitol XH, registeredtrademark of Union Carbide Corp.)Pheno1 5.34Monochlorobenzene 76.96 100.00B. Compound of Example No. 14 25.00Free acid of complex organic 5.00phosphate of aromatic oraliphatic hydrophobe base(e.g., GAFAC RE-610)Polyoxyethylene/polyoxypropylene 1.60block copolymer with butanol(e.g., Tergitol XH)Phenol 4.75Monochlorobenzene 63.65 100.00II. FlowablesA. Compound of Example No. 24 25.00Methyl cellulose 0.3Silica Aerogel 1.5Sodium lignosulfonate 3.5Sodium N-methyl-N-oleyl taurate 2.0Water 67.7 100.00B. Compound of Example No. 18 45.0Methyl cellulose .3Silica aerogel 1.5Sodium lignosulfonate 3.5Sodium N-methyl-N-oleyl taurate 2.0Water 47.7 100.00III. Wettable PowdersA. Compound of Example No. 5 25.0Sodium lignosulfonate 3.0Sodium N-methyl-N-oleyl-taurate 1.0Amorphous silica (synthetic) 71.0 100.00B. Compound of Example 21 80.00Sodium dioctyl sulfosuccinate 1.25Calcium lignosulfonate 2.75Amorphous silica (synthetic) 16.00 100.00C. Compound of Example No. 6 10.0Sodium lignosulfonate 3.0Sodium N-methyl-N-oleyl-taurate 1.0Kaolinite clay 86.0 100.00IV. DustsA. Compound of Example No. 13 2.0Attapulgite 98.0 100.00B. Compound of Example No. 10 60.0Montmorillonite 40.0 100.00C. Compound of Example No. 54 30.0Ethylene glycol 1.0Bentonite 69.0 100.00D. Compound of Example No. 62 1.0Diatomaceous earth 99.0 100.00V. GranulesA. Compound of Example No. 52 15.0Granular attapulgite (20/40 mesh) 85.0 100.00B. Compound of Example No. 70 30.0Diatomaceous earth (20/40) 70.0 100.00C. Compound of Example No. 58 1.0Ethylene glyco1 5.0Methylene blue 0.1Pyrophyllite 93.9 100.00D. Compound of Example No. 46 5.0Pyrophyllite (20/40) 95.0 100.00______________________________________ When operating in accordance with the present invention, effective amounts of the compounds of this invention are applied to the soil containing the seeds, or vegetative propagules or may be incorporated into the soil media in any convenient fashion. The application of liquid and particulate solid compositions to the soil can be carried out by conventional methods, e.g., power dusters, boom and hand sprayers and spray dusters. The compositions can also be applied from airplanes as a dust or a spray because of their effectiveness at low dosages. The exact amount of active ingredient to be employed is dependent upon various factors, including the plant species and stage of development thereof, the type and condition of soil, the amount of rainfall and the specific compounds employed. In selective preemergence application or to the soil, a dosage of from about 0.02 to about 11.2 kg/ha, preferably from about 0.1 to about 5.60 kg/ha, is usually employed. Lower or higher rates may be required in some instances. One skilled in the art can readily determine from this specification, including the above examples, the optimum rate to be applied in any particular case. The term "soil" is employed in its broadest sense to be inclusive of all conventional "soils" as defined in Webster's New International Dictionary, Second Edition, Unabridged (1961). Thus, the term refers to any substance or media in which vegetation may take root and grow, and includes not only earth but also compost, manure, muck, humus, sand, and the like, adapted to support plant growth. Although the invention is described with respect to specific modifications, the details thereof are not to be construed as limitations.

1a

This invention relates to freestanding roadside structures, such as curbside stone or brick mailbox structures, and methods for making the same. BACKGROUND OF THE INVENTION Freestanding structures of the type to which the present invention relates include entranceways, fence posts, mailboxes and similar structures typically found curbside and elsewhere on street rights-of-way. In recent years, there has been a proliferation especially of immovable roadside mailboxes which are a hazard to motorists and quite frequently violate building codes and local ordinances. Roadside mailbox structures of brick, stone, concrete block and the like have an aesthetic appeal in that they provide a pleasing structure that comports with the color, texture and appearance of the house or other main structure with which they are associated. In a usual construction, such roadside mailboxes may be built up of solid bricks or stones, or may be fabricated by erecting a wood or concrete block substructure in situ which is covered with a brick, stone or other masonry facade. Such structures present a serious safety hazard when struck by vehicles. When hit they are either totally immovable, giving the effect of crashing into a solid wall, or else the constituents thereof become dangerous projectiles that can cause secondary injuries beyond the impact with the structure itself. There are also structural problems with such structures. Uneven ground shifting causes premature and unsightly cracking, with individual bricks or other building elements sometimes becoming dislodged and ending up in the roadway. The mail signal flag also comes loose or falls out because it has not been securely fastened to the hard materials. Immovable roadside structures continue to be built despite local prohibitions against their construction on street rights-of-way and despite state and federal road guidelines that require that they break off without serious damage to a vehicle when hit. SUMMARY OF THE INVENTION It is an object of the present invention to overcome the above and other drawbacks of the prior art by providing a breakaway freestanding roadside structure formed of a block of rigid lightweight shape-giving material to which a decorative coating material is applied to comport with the external appearance of an associated main structure. In one aspect of the invention, discussed in greater detail below, a roadside mailbox is provided having a preformed block of rigid lightweight plastic foam material covered with one or more coatings of cementitious material and a mailbox secured within a cutout thereof. In another aspect of the invention a method for construction of a roadside structure is provided in which a form giving preformed block of rigid lightweight plastic foam material is covered with coatings of cementitious material in a manner that permits recesses to be formed, texturing to be given, and coloring to be added so as to closely match and simulate the external stone, brick or other masonry appearance of an associated main structure. In preferred embodiments, discussed in greater detail below, the structure and method of the invention utilizes preformed blocks of styrofoam which are covered with layers of stucco shaped to give the desired.texture and appearance, and to one or more of which coloring pigmentation is added. In a described mailbox embodiment, a flag is secured by extending a fastener from the outside of the structure all the way through to the inside of a mailbox received in a cutout therein. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the invention have been chosen for purposes of illustration and description, and are shown in the accompanying drawings, wherein: FIGS. 1A-1H are views, including partial sections, of the steps of the method of the invention, with the structure of the invention formed as a product thereof; FIG. 2 an exploded view of one step in an embodiment of the method of FIG. 1; FIG. 3 is a view of a planter mailbox form of the invention; FIG. 4 is a view of an entranceway post version of the invention, and FIGS. 5A-5B show a fence post version of the invention. Throughout the drawings, like elements are referred to by like numerals. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1A-1H show the construction of a breakaway freestanding roadside structure in accordance with the invention, in the form of a brick mailbox for curbside installation. A preformed block 10 of rigid lightweight plastic foam material, preferably styrofoam, is provided with a cutout 11 opening onto a front surface thereof and into which a standard aluminum rural delivery mailbox fixture 12 (FIGS. 1A and 1B) is inserted. The block 10 serves to establish the shape of the end mailbox structure and is chosen accordingly. The embodiment illustrated in FIGS. 1A-1H utilizes a block 10 of parallelpiped configuration having a height of 42"-48" and a flat 18"×18" square top and base. Other possible configurations include a top which is rounded, cascaded or pagoda-shaped. The cutout 11 can easily be achieved using conventional plastic foam material cutting means, such as a hot wire cutting tool. Undesired openings, such as a cutout access line 13 (FIG. 1A), are covered with commercially available fiberglass mesh tape, or other patching substance. The cutout is dimensioned to tightly envelop the mailbox, with just enough of the front of the mailbox left out (about 1") to permit the opening of the box lid for mail insertion and retrieval. The box may be secured within the cutout using an adhesive, such as a silicon elastomer. With the fixture 12 in place in the cutout 11, a first scratch coat of masonry stucco material is hand-troweled with a masonry trowel evenly over the entire exposed outside of the block 10 to form a coating 14, which is allowed to dry completely (FIG. 1B). A 1/8" to 1/4" thickness of coating 14 is suggested, with a drying time of one to three days depending on air moisture conditions. A second thicker coating 15 of stucco, to which coloring material has been added, is then applied over the first coat 14 and allowed to partially dry (FIG. 1C). A third coating 16, also to which coloring material has been added is then applied over the second coat 15 after a few hours when the second coat has not yet completely dried (FIG. 1D). The third coat, while wet, is then hand cut (FIG. 1E) to simulate individual bricks by introducing horizontal and vertical recesses 17, 18 thereto which extend down into the second layer 16. The cuts can be made with the assistance of shapers, templates or similar implements. The coloring material (which may take the form of cement color pigments such as available commercially from Lambert Davis, for example) added to the second coating 14 serves to establish the color of the simulated mortar joint lines between the bricks. The color of the third coating 16 establishes the basic brick color. The outer coating 16 can be shaped, marked, scored, etc. as desired to give the texture of the brick runs to be simulated, i.e. rough brick, Chicago brick, etc. External coloring can be brush painted on the outer surface of coating 16 at this stage, or later after the structure has been set in its end use position, to more closely match the appearance of actual brick. Although the coatings 14, 15, and 16 are preferably of stucco, as described, other cementitious coating materials are also possible that will adhere to the block 10 and give the desired appearance. Also, while the simulation of brickwork has been described, block, stone or other building facades (plain stucco, coral, wood, etc.) can be simulated by selection of appropriate color additives and corresponding differences in recess shaping and texture. The second and third coatings 15, 16 are applied in appropriate depths depending on the surface to be simulated. Simulation of a Tennessee rock exterior will, for example, require a much thicker outer coat 16, with recesses 17, 18 formed as wandering paths and the islands left between the recesses being contoured to resemble rock faces. A total thickness "A" (FIG. lE) can typically be 1/2" for a plain unrecessed stucco effect, 3/4" for simulated brick, and 2 1/2 for stone simulation. To keep the total weight of the fabricated structure down, the stucco used for the coatings 14, 15, 16 may advantageously be mixed with a lightweight aggregate material. A 50:50 mixture of commercially available Permalite™ plaster/tile aggregate filler material added to the stucco has been found appropriate. Using such a mixture for successively coating a block 10 of styrofoam material of about 10 pounds weight, a total end structure weight of 75 to 100 pounds is achieved. FIG. 1E illustrates the freestanding structure of the invention which is fabricated in accordance with the described method. The finished structure is of lightweight material and can be conveniently delivered to a roadside location for installation. A preferred installation method is illustrated by the steps shown in FIGS. 1F-1H. The structure is set on the ground at the desired location and a boundary is marked extending 4" from the edge of the structure base, as shown. The structure is then removed and the ground dug out in the marked area to a depth of 4" (FIG. 1G). The structure is then again set down in centered position within the dug out hole and a concrete collar 19 is poured in the marginal region between the edge of the structure and the edge of the hole (FIG. 1H). If the climate so requires, the concrete collar can be replaced by a collar in the form of an expansion joint pad. Final color matching of the exterior of the structure to the exterior of an associated house or the like can be done after installation by painting additional pigmentation marks over the top layer 16. At a convenient point in the assembly or installation process, a mail flag 20 is added to the mailbox structure, as shown in FIG. 2. This is preferably done after completion and shaping of the third coating 16 but before delivery to the installation site. The flag 20 is placed in position within a slotted flag bracket 21 which is brought flush against one side of the coated block 10. A piece of threaded rod 22 of suitable length is then run through the bracket 21 and flag 20, through the block 10 from the exterior of the structure to the mailbox 11, and through an aperture 23 in the wall of the box 13 to the interior of the box. The rod is secured by a cap nut 24, fitted onto its bracket 21 end and a flat nut 25 threaded at its mailbox 11 end. A plastic spider washer 26 is positioned between the bracket 21 and the third coating 16. The flag mounting arrangement, except for the extensive rod 22, is essentially the same as the arrangement for direct mounting of a flag on a mailbox 12 which is placed on a roadside post mounting, and utilizes the same parts. The extended rod 22 offers an improvement over conventional methods of mounting flags to immovable brick mailbox structures, because such mountings do not connect the flag all the way through the brick to the box. This leads to the flags becoming dislodged because they come loose from the brickwork, and makes replacement of a broken flag mechanism difficult. With the direct mounting connection between the flag and the mailbox insert 12 contemplated by the present invention, as shown in FIG. 2, both installation and replacement are facilitated. The rod 22 is preferably heated for ease in poking it through the styrofoam to the mailbox aperture 23. FIG. 3 shows a version of a mailbox similar to that produced by the method described in connection with FIGS. 1A-1H, to which a planter 30 including an upper cutout 31 has been added. The planter form 30, which is preferably of the same preformed block material as the form 32 of the mailbox form proper, is attached by means of silicon elastomer or other suitable adhesive to the main mailbox structure at the FIG. 1A step in construction. (The main mailbox structure of FIG. 3 has a rounded top in contrast to the flat top previously described.) Stucco coatings are then successively added and installation proceeds as discussed with respect to FIGS. 1B-1H. FIG. 4 illustrates a roadside structure in accordance with the invention having the same breakaway feature and taking the form of an entranceway post 40. The post is divided into two blocks 41, 42 which are secured together in known ways at a first construction step (i.e. as in FIG. 1A.) The first block 41 has a generally parallelpiped shape, and the second block 42 has an elongated, tapered shape. Coatings are added to the joined blocks and the same are installed at a roadside location in accordance with a method similar to that of FIGS. 1B-1H. The embodiment of breakway freestanding structure shown in FIGS. 5A-5B takes the form of a fence post 50 which has the same preformed block structure as previously described. Here, However, cutouts take the form of circular openings 51 which extend horizontally all the way through the block structure. The openings are lined with PVC pipe protectors 52 which adhere with silicon elastomer or other material to the block and protect the block from PVC, wooden or other rails 53 which can be added to extend between fence posts. FIG. 5B illustrates fence posts in which the cutouts extend only partially through the block to serve as end posts. In another embodiment (not shown), PVC tubing can be inserted within channels in the styrofoam to provide conduits for electric wiring for the addition of lighting fixtures, etc. Embodiments of the structure of the invention constructed and installed in accordance with the above described method provide a breakaway freestanding roadside structure with significant advantages over immovable prior art structures. Should a vehicle collide with the structure, the structure will break free of the collar and be moved in one piece, causing relatively little damage to the driver. The structure is lightweight, easily constructed and readily conformable to the external appearance of an associated main structure. The unity and integrity of the finished structure avoids the disparate shifting experienced by the prior art immovable structures that causes cracks and dislodging of materials. The selection of polystyrene as the preferred shape forming material provides an inert, mildew and rot resistant substructure that is readily formable and easy to work with. The choice of a stucco-aggregate mixture for the cementitious coating material likewise provides an easily utilized, readily available, durable substance. Those skilled in the art to which the present invention relates will recognize that various substitutions and modifications may be made to the illustrative embodiments, without departing from the spirit and scope of the present invention as defined by the claims appended hereto, and such variations are intended to be covered hereby.

1a

CROSS-REFERENCE TO RELATED APPLICATION The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/793,245 filed Apr. 20, 2006 entitled “Wash/Rinse System For a Drawer-Type Dishwasher.” BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention pertains to the art of dishwashers and, more particularly, to a wash/rinse system for a drawer-type dishwasher. 2. Discussion of the Prior Art Drawer-type dishwashers are widely known in the art and, once again, gaining popularity with consumers. Typically, a drawer-type dishwasher will include a drawer or washing tub that is slidably mounted in a cabinet. A dish rack is provided within the washing tub to support dishware and the like during a washing operation. In any event, various models of drawer-type dishwasher are available to today's consumers. The dishwasher can range from a single drawer unit to multi-compartment units that are arranged in upper and lower or side-by-side configurations. The multi-compartment units include either multiple drawers or, a combined drawer and conventional type dishwasher. However, regardless of the particular configuration, a drawer-type dishwasher includes a lid that selectively seals the washing tub during a wash operation. During the washing operation, washing fluid is sprayed onto kitchenware and the like situated in the washing tub. The washing fluid is directed from a lower wash arm and, often times, from a wash arm mounted to the lid. In this manner, the manufacturer ensures that all of the kitchenware is exposed to jets of washing fluid during the washing operation. While effective at establishing a more uniform distribution of washing fluid, upper or lid mounted wash arms are prone to leak or drip water onto internal dishwasher components when the drawer is withdrawn from the cabinet. Water dripping onto internal machine components can cause erosion problems that may ultimately create maintenance or premature failure issues for the consumer. Thus, based on the above, there still exists a need in the art for a drawer-type dishwasher that includes a wash/rinse system that directs sprays of washing fluid into upper portions of a washing chamber wherein, when the drawer is removed for unloading/loading dishwasher, washing fluid does not drip onto internal dishwasher components. SUMMARY OF THE INVENTION The present invention is directed to a wash/rinse system for a drawer-type dishwasher including an outer support body, a drawer slidingly received in the outer support body having front, rear, bottom and opposing side walls that collectively define a washing chamber, a lid shiftably mounted in the outer support body for selectively closing the washing chamber, and a dishrack positioned in the washing chamber for supporting articles to be exposed to a washing operation. In accordance with the invention, the wash/rinse system includes a wash mechanism having a paddlewheel provided with at least one deflector member and a spray bar. The spray bar is provided with at least one nozzle and is mounted in the washing chamber adjacent the paddlewheel. In further accordance with the invention, the at least one nozzle is positioned so as to deliver a jet of washing fluid onto the at least one deflector member in order to impart a rotational force to the paddlewheel. Upon impacting the at least one deflector member, the jet of washing fluid diverges into a stream(s) of washing fluid which is sprayed onto articles supported in the washing chamber during the washing operation. Preferably, the spray bar includes a plurality of nozzles which direct multiple jets of washing fluid onto a corresponding plurality of deflector members. In the most preferred form of the invention, the paddlewheel is mounted at an upper portion of the back wall of the washing chamber, with the plurality of deflector members being positioned at various angles or orientations so as to create random streams of washing fluid that are sprayed about the washing chamber. In this manner, the random streams of washing fluid combine with washing fluid emanating from a lower wash arm to clean the articles supported upon the rack. Additional objects, features and advantages of the present invention will become more readily apparent from the following detailed description of preferred embodiments when taken in conjunction with the drawings wherein like reference numerals refer to corresponding parts in the several views. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an upper right perspective view of a drawer-type dishwasher incorporating a wash/rinse system constructed in accordance with the present invention; FIG. 2 is an upper right, partially cut-away perspective view of a drawer portion of the dishwasher of FIG. 1 illustrating the wash/rinse system mounted in accordance with the present invention; FIG. 3 is an upper right perspective view of the wash/rinse system of FIG. 2 ; FIG. 4 is a perspective view of an inlet nozzle portion of the wash/rinse system; FIG. 5 is an exploded view of a feed member portion of the wash/rinse system; FIG. 6 is a perspective view of the inlet nozzle of FIG. 4 being attached to the feed member of FIG. 5 at a rear wall of the wash chamber; FIG. 7 is a rear view of the washing chamber of FIG. 2 illustrating a flow sensor mounted in accordance with the present invention; and FIG. 8 is a wash/rinse system constructed in accordance with an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT With initial reference to FIGS. 1 and 2 , a dishwasher constructed in accordance with the present invention, is generally indicated at 2 . Dishwasher 2 includes an outer support body 4 which is positioned below a kitchen countertop 6 along side a plurality of cabinets 8 . As shown, cabinets 8 include drawers 9 - 12 and a door 13 . As further shown, dishwasher 2 includes an upper washing unit or drawer 16 , as well as a lower washing unit or drawer 18 . As each washing unit 16 , 18 is similarly constructed, a detailed description will be made with respect to upper washing unit 16 with an understanding that lower washing unit 18 includes corresponding structure. Upper washing unit 16 includes a front wall 20 , a rear wall 21 , a bottom wall 22 and opposing side walls 23 and 24 that collectively define an upper washing chamber 28 . A dishrack 30 is positioned within upper washing chamber 28 to support kitchenware, indicated generally at 31 , which may include plates, cups or the like. Upper washing unit 16 is slidably supported within outer support body 4 through a pair of extensible drawer glides, one of which is indicated at 33 . Finally, dishwasher 2 is shown to include a lid 37 that is selectively shiftable relative to washing chamber 28 as drawer 16 is moved into and out of outer support body 4 . Dishwasher 2 selectively performs a washing operation in washing chamber 28 during which sprays or jets of washing fluid are directed onto kitchenware 31 by a lower wash arm 47 , as well as an upper washing mechanism 50 . In the embodiment shown, upper washing mechanism 50 is positioned at an upper portion of rear wall 21 . As best shown in FIGS. 2 and 3 , upper washing mechanism 50 includes a water delivery portion 56 having an inlet conduit 58 which directs a flow of washing fluid towards a spray bar 60 . In accordance with the invention, inlet conduit 58 includes a first end section 63 that extends to a second end section 64 through an intermediate section 65 . First end section 63 is preferably domed-shaped so as to receive an inlet nozzle 69 therein (see FIG. 4 ) as will be discussed more fully below. As further shown in FIG. 3 , spray bar 60 includes a first end portion 90 that extends to a second end portion 91 through an intermediate portion 92 that defines a central trough 97 . First and second end portions 90 and 91 actually define support members in a manner that will be detailed more fully below. In any event, spray bar 60 is actually fluidly connected to second end section 64 of inlet conduit 58 so as to receive a flow of washing fluid from inlet nozzle 69 . The flow of washing fluid is directed outward from central trough 97 through a plurality of nozzles 104 - 111 . Actually, trough 97 is divided into first and second lateral sections or zones 114 and 115 by a central support member 112 , with nozzles 104 - 107 being positioned in first lateral zone 114 and nozzles 108 - 111 being positioned in second lateral zone 115 . Upper washing mechanism 50 also includes a paddlewheel member 119 rotatably supported within trough 97 of spray bar 60 . Paddlewheel member 119 actually includes a first paddle support 121 having a first end section 122 that extends to a second end section 123 through an intermediate section 124 . First paddle support 121 is arranged within first lateral zone 114 of trough 97 . Arranged alongside first paddle support 121 , in second lateral zone 115 , is a second paddle support 129 . In a manner similar to that described above, second paddle support 129 includes a first end section 130 , a second end section 131 and an intermediate section 132 . First and second paddle supports 121 and 129 are rotatably supported upon a central rod 135 that extends substantially the entire length of trough 97 . Towards that end, central rod 135 includes first and second outer bearing elements 137 and 138 that are rotatably supported upon first and second end sections 90 and 91 of spray bar 60 , as well as a central bearing/support portion 139 that rests upon central support member 112 . In any case, as each paddle support 121 , 129 is substantially, identically constructed, a detailed description will be made with respect to first paddle support 121 with an understanding that second paddle support 129 is correspondingly constructed. First paddle support 121 includes a plurality of disk-shaped deflector members 145 - 147 positioned adjacent nozzles 104 , 106 and 107 respectively, as well as a paddle-shaped deflector member 150 positioned adjacent to nozzle 105 . With this arrangement, a jet of washing fluid exiting nozzle 105 impacts paddle-shaped deflector member 150 causing first paddle support 121 to rotate about an axis defined by central rod 135 . As first paddle support 121 rotates, additional jets of washing fluid emanating from nozzles 104 , 106 and 107 impact disk-shaped deflector members 145 - 147 respectively, causing the jets of washing fluid to diverge into streams of washing fluid which are directed onto kitchenware supported upon dishrack 30 . As discussed above, washing fluid is introduced into upper washing mechanism 50 through inlet nozzle 69 illustrated in FIG. 4 . In accordance with the invention, inlet nozzle 69 includes a main body portion 160 having a base section 162 , provided with a circular flange 163 , which extends through an intermediate section 164 to a tapered or nozzle section 165 . Nozzle section 165 is provided with a plurality of openings, one of which is indicated at 167 , as well as a diffuser 169 . Diffuser 169 includes an aperture 171 that receives a mechanical fastener 174 (see FIG. 3 ) which secures upper washing mechanism 50 to washing chamber 28 . In addition to mechanical fastener 174 , upper washing mechanism 50 is also retained against rear wall 21 by a mounting bracket 184 . In further accordance with the invention, mounting bracket 184 includes a main body 186 having a ring portion 188 from which extends an intermediate or planar portion 189 before terminating in a support portion 190 . Support portion 190 includes first and second ear elements 192 and 193 , each provided with a corresponding tab element 196 , 197 that snap-fittingly engages inlet conduit 58 . As will be discussed more fully below, mounting bracket 184 is secured against rear wall 21 of washing chamber 28 through circular flange 163 of inlet nozzle 69 . As best shown in FIGS. 5 and 6 , inlet nozzle 69 is connected to and receives a flow of washing fluid through an inlet feed member 206 extending through rear wall 21 of washing chamber 28 . Inlet feed member 206 includes a conduit portion 208 and a base portion 210 . Conduit portion 208 includes a main body section 214 having a base section 215 from which extend an inlet nipple 216 and an outlet nipple 217 . Main body section 214 also includes a flange 222 having a pair of mounting ears, one of which is indicated at 225 . As will be discussed more fully below, flange 222 acts as an interface between conduit portion 208 and base portion 210 . Outlet nipple 217 includes a hollow interior portion 228 that leads into base section 215 and fluidly connects to inlet nipple 216 . Outlet nipple 217 also includes a plurality of external threads 231 which, as best shown in FIG. 6 , engage with inlet nozzle 69 . More specifically, outlet nipple 217 extends through rear wall 21 of washing chamber 28 and ring portion 188 of mounting bracket 184 . Once in place, inlet nozzle 69 is secured to inlet feed member 206 through threads 231 , with circular flange 163 trapping mounting bracket 184 against rear wall 21 . Finally, inlet nipple 217 is shown to include a pair of outer rings 235 and 236 which provide a positive engagement for a hose 238 that is secured through a clamp 239 (see FIG. 7 ). With this arrangement, inlet feed member 206 receives a flow of washing fluid from a pump (not shown) through inlet nipple 216 . The flow of washing fluid is thereafter redirected outward through outlet nipple 217 into inlet nozzle 69 and into spray bar 60 . As stated above, conduit portion 208 is supported upon a base portion 210 through flange 222 . Towards that end, base member 210 is provided with a main housing 245 that includes a mounting member 247 and a cover 248 . Mounting member 247 is provided with a pair of supports 260 and 261 that align with mounting ears 225 . Supports 260 and 261 are adapted to receive mechanical fasteners, one of which is shown at 265 , to secure conduit portion 208 to base portion 210 . Mounting member 247 further includes a central opening 267 that leads into main housing 245 . A seal 269 extends about central opening 267 and engages with flange 222 of conduit portion 208 . In addition, cover 248 is pivotally connected to mounting member 247 through a hinge 270 and secured through a tab member 273 . Actually, main housing 245 serves as an enclosure for electronic circuitry 280 (see FIG. 7 ) associated with a flow sensor 283 , such as a diaphragm positioned across central opening 267 . Sensor 283 senses the flow of washing fluid through conduit portion 208 during an overall washing operation. Reference will now be made to FIG. 8 in describing an alternative embodiment of the present invention. As shown, an upper wash mechanism 350 includes a water delivery portion 356 having an inlet conduit 358 that is connected to a spray bar 360 . Spray bar 360 includes a first end section 390 that extends to a second end section 391 through an intermediate section 392 . Actually, arranged at intermediate section 392 is a “T” member 394 that directs a flow of washing fluid into a first lateral zone 360 and a second lateral zone 361 . Each lateral zone 360 , 361 includes a plurality of nozzles 404 - 406 and 407 - 409 respectively. Jets of washing fluid emanating from nozzles 404 - 409 impact upon a paddlewheel member 419 that is rotatably mounted to a pair of laterally spaced first and second support members 421 and 429 . Actually, paddlewheel member 419 is provided with a pair of bearings, one of which is indicated at 438 , that provide smooth rotation as paddlewheel 419 is impacted and rotated by jets of washing fluid emanating from nozzles 404 - 409 . In addition, paddlewheel member 419 is provided with a slight twist or spiral which ensures continued exposure to the jets of washing fluid. Thus, in accordance with the embodiment shown, paddlewheel member 419 constitutes an overall deflector member 445 that causes the jets of washing fluid to diverge into a plurality of streams which subsequently impact upon kitchenware supported upon dishrack 30 during an overall washing operation. At this point, it should be readily understood that the present invention provides for an efficient upper washing mechanism for directing water to an upper portion of a washing chamber in a drawer-type dishwasher. More particularly, mounting the upper washing mechanism to a wall of the wash chamber advantageously provides protection to various wash system components arranged within outer housing 4 . More specifically, the particular positioning of the upper washing mechanism ensures that any residual water remaining within the wash system drops directly into the washing chamber and not onto various components carried within outer housing 4 as would be the case with a wash arm mounted to, for example, lid 37 . In addition, the paddlewheel configuration establishes an extremely efficient and effective washing fluid distribution arrangement that creates streams of washing fluid sprayed randomly about the washing chamber. In any case, although described with reference to preferred embodiments of the invention, it should be readily understood that various changes and/or modifications can be made to the invention without departing from the spirit thereof. For instance, the overall shape, angular orientation, number and spacing of the deflector members can vary in accordance with the present invention. In general, the invention is only intended to be limited by the scope of the following claims.

1a

BACKGROUND OF THE INVENTION The present invention relates to an applicator intended for local treatment of the skin; such a treatment is, for example, treatment for spots or for blotches. The aim of the invention is to provide an applicator which is capable of delivering an infinitesimal dose directly to the skin in a very precise manner and of additionally permitting the massage of the skin. SUMMARY OF THE INVENTION According to the present invention, such an applicator includes a reservoir which contains a substance to be applied, a cap which is intended to close the reservoir, and an applicator holder supporting a deformable element for applying the substance, the element being made of foam or of low-hardness elastomer, and is characterized by the fact that the deformable element has a roughened surface and is provided with a substantial shape memory, and in that the reservoir holding the substance is limited by a finger-shaped capillary end-piece having a base equipped with a seat which is pierced with at least one capillary orifice against which the deformable element is applied and deformed in the position in which the reservoir is closed by the cap. The application element advantageously includes a foam with open cells which communicate with one another when the deformable element is not deformed. By virtue of this arrangement, when the deformable element is compressed on the seat of the base of the capillary end-piece, its surface in contact with the seat is increased; when the applicator is opened, that is to say when the cap is separated from the reservoir, the deformable element recovers its initial shape which it has in the free state and creates a suction effect which draws up the drop of substance, held hitherto by capillarity on that face of the base of the capillary end-piece which is opposite the one bearing the seat, on account of the presence of the capillary orifice. The design of the applicator according to the invention permits, in a simple manner, the provision of several functions. The deformable element compressed on the seat ensures the sealing of the reservoir. The considerable shape memory of the deformable element permits the function of pumping and suctioning of the substance. The flexibility of the deformable element permits a local massage of the skin. The capillary orifice, of which there is at least one, is advantageously circular and its diameter is between 0.5 and 3 mm; alternatively, the capillary orifice, of which there is at least one, is a slit having a cross-section of between 0.2 and 7 mm 2 . The end of the deformable element which cooperates with the seat and the orifice is flat, or in the shape of a conical tip, or round. The applicator holder supporting the deformable element preferably includes a hollow rod; alternatively, it includes a rigid support sleeve in the shape of an ogive. According to another alternative, the applicator holder includes a rigid solid rod; the solid rod is advantageously equipped, at its end, with a stiffening element of elongate shape for guiding the deformable element during its deformation. The capillary end-piece is supported by a spacer element which is integral with the reservoir and through which the applicator holder passes. According to a preferred embodiment, the capillary orifice opens into the reservoir along a flared, frustoconical portion which serves as a capillary reservoir. The dimensions of the capillary orifice will be adjusted depending on the viscosity of the substance to be applied. The capillary end-piece is advantageously made of semi-rigid material; alternatively, the end-piece is made of a rigid material. BRIEF DESCRIPTION OF THE DRAWINGS In order to permit a better understanding of the subject-matter of the invention, a description will now be given, by way of a purely illustrative and non-limiting example, of an embodiment thereof which is shown in the attached drawings. In these drawings: FIG. 1 is a partial sectional view of an applicator according to the invention; FIG. 2 is similar to FIG. 1, but the applicator is shown in the open position; FIGS. 3 to 5 are partial sections showing the respective positions of the deformable element during the functioning as a capillary pump; FIGS. 6 to 8 each show an alternative of the deformable element for an applicator according to the invention; FIGS. 9 to 11 each show an alternative of the applicator holder supporting an alternative of the deformable element, for an applicator according to the invention; FIG. 12 is a partial sectional view of an alternative of the applicator according to the invention; FIG. 13 is a view along XIII--XIII in FIG. 12; FIG. 14 is a partial sectional view of an alternative of the applicator according to FIG. 12; FIG. 15 is a partial sectional view of another applicator according to the invention; FIGS. 16/I to 16/V show different cross-sectional shapes of the capillary orifice; FIGS. 17 and 18 represent, in longitudinal section, two alternatives of the capillary orifice; FIG. 19 is a partial sectional view of another alternative of the applicator according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS According to FIG. 1, an applicator 1 includes a reservoir 2 in the shape of a cylinder which has a base and is open at one end; a spacer element 10 of the same cross-section as the reservoir 2 is force-fitted through this end until a flange 26 of the spacer element 10, of an external diameter equal to the external diameter of the reservoir 2, abuts the frontal outer edge of the opening of the reservoir 2. The spacer element 10 supports a finger-shaped end-piece 11; to do this, the spacer element 10 includes an axial cylindrical recess 13 extended via a coaxial passage 14 of smaller diameter, which is itself extended via a flared area 15 opening to the outside; in line with this flared area 15, the spacer element 10 has an external thread 16 on the surface of a cylindrical end portion which is of a smaller diameter than that of the part of the spacer element 10 fitted in the reservoir 2. At the end of the spacer element 10 distinct from the end which has the thread 16, the spacer element 10 is equipped with an annular bulge 17 for snap-in fitting; the end-piece 11 is housed in the cylindrical recess 13; the end-piece 11 is in the shape of a finger and defines a cylindrical chamber 25 and a base 20: the base 20 has a seat 24 pierced with a capillary orifice 23; the base 20 is bordered by a flange 21 for snap-fitting which is of a shape complementary to that of the annular bulge 17 of the spacer element 10, allowing the end-piece 11 to be joined to the spacer element 10 by snap-fitting. The base 20 of the end-piece 11 is at a distance from the base 3 of the reservoir 2 for a substance 5 to be applied. The applicator 1 also includes a cap 4 represented partially in the figures; the cap 4 is also in the shape of a cylinder which has a base (not represented) and is open at one end; a stopper 40 having the same cross-section as the cap 4 is force-fitted through this end, the cap 4 itself having a cross-section similar to that of the reservoir 2; the stopper 40 is fitted into the cap 4 until a flange 45 of the stopper 40 abuts the outer edge of the opening of the cap 4. The stopper 40 has a top 41 in which there is formed a cavity 42 extended via a bore 43 of greater diameter which has on the inside a thread 44 complementary to the thread 16 of the spacer element 10. The stopper 40 is integral with an applicator holder 30 supporting a deformable application element 35 made in this example, of a foam; the applicator holder 30 includes a hollow rod 31, pierced with a bore 32, one end of which has longitudinal fins 33 for holding the rod 31 in the cavity 42 of the top 41 by forcefitting. The other end of the rod 31 is equipped with a rigid supporting sleeve 34 in the shape of an ogive holding the deformable element 35 via its end of smaller diameter defining a constriction 36. In an alternative which is not represented, the deformable element 35 is held directly by the hollow rod 31. The deformable element 35 is made of a material having a considerable shape memory. In the position represented in FIG. 1, the applicator is closed; the cap 4 is screwed onto the reservoir, a sealing joint 50 being placed around the rod 31, between the stopper 40 and the spacer element 10; in this closure position, the deformable element 35 is crushed against the seat 24 and the orifice 23. A ball 60 is housed in the reservoir 2 and permits agitation of the substance 5, if necessary. The orifice 23 opens into the reservoir 2 along a flared, frustoconical portion 22. By virtue of the capillary orifice 23, whose diameter is of the order of 0.5 to 3 mm, a drop 6 of substances adheres by capillarity to the surface of the base 20 opposite the seat 24. FIG. 2 shows the applicator 1 in an open position, just before use; in this position, which corresponds to a position in which the cap 4 is drawn back with respect to the reservoir 2, the deformable element 35 has recovered its initial position; the deformable element 35 is charged with a part 8 of the drop 6 of substance, the remainder 7 of the substance obstructing the orifice 23 in which it is held by capillarity. The manner in which the deformable element 35 is charged with substance is illustrated in FIGS. 3 to 5; in these figures, the base of the end-piece 11, in which the capillary orifice 23 is formed, has been represented diagrammatically. FIG. 3 corresponds to the closed applicator, the drop 6 of substance being held by capillarity; FIG. 5 corresponds to the position in which the deformable element 35 is charged with a part 8 of the drop 6 of substance 5, the orifice being obstructed by the remainder 7 of the substance 5; FIG. 4 corresponds to an intermediate position in which a drop 6A is smaller than the drop 6 in FIG. 3, the deformable element 35 having begun to be charged with substance, as it gradually recovers its original shape. The deformable element 35 can have different shapes at rest: thus, according to FIG. 6, the deformable element 135 has a flat end; according to FIG. 7, the deformable element 235 has the shape of a rounded conical tip; according to FIG. 8, the deformable element 335 has a spherical end. The deformable element has a roughened surface which can be of any type: it can include a large number of protrusions separated by small cavities, or of fine circular and parallel grooves, as illustrated in FIG. 7. According to the alternatives in FIGS. 9 to 11, the applicator holder 400, 500, 600 includes a solid rod 431, 531, 631 whose end is shaped to support the deformable element 435, 535, 635, here preferably made of low-hardness elastomer; low-hardness elastomer is understood to mean an elastomer whose hardness is between 15 Shore A and 70 Shore A. This elastomer is made up of open-cell foam. According to FIG. 9, the solid rod 431 has, at its end, a cylindrical recess 432 in which an end 436 of the deformable element 435 is tightly fitted. According to FIG. 10, the solid rod 531 has, at its end, an annular cylindrical recess 532 bordered at the center with a stiffening element 534 of elongate shape, along the axis of the rod 531, the axial length of the stiffening element 534 being greater than that of the recess 532; the deformable element 535 has a cavity 538 of a shape complementary to that of the stiffening element 534 on which it is engaged tightly, the end 536 of the element 535 being likewise fitted tightly in the recess 532; the stiffening element 534 makes it possible to guide the deformable element 535 during its deformation. According to FIG. 11, the solid rod 631 has, at its end, a stiffening element 634, without the annular recess in the preceding alternative; a radial protrusion 637 with which the stiffening element 634 is equipped permits a better axial support of the deformable element 635. FIGS. 12 and 13 show an alternative of the applicator in which the capillary end-piece 11, which limits the substance reservoir 2, is equipped with a seat 24 pierced with several capillary slits 230, six slits in the shape of arcs of a circle in the example represented in these figures; these slits can of course have, in cross-section, any suitable shapes, such as, for example, those represented in FIGS. 16/I to 16/V; these slits can have, in longitudinal section of the base 201, frustoconical shapes 231, as shown in FIG. 17, or partially frustoconical shapes 232, as shown in FIG. 18, in such a way as to form a reserve of substance. The end-piece 11 in this alternative is made of a rigid material and has threads 203 on the outer surface of an upper part 202 thereof; the upper part 202 is extended downwards via a flared skirt 200 surrounding the seat 24, being at a radial distance from the latter; the skirt 200 covers the reservoir 2, of the hemispherical-shaped type, and is made integral with the reservoir 2, for example by adhesive bonding; the reservoir 2 is advantageously made of a transparent material. The threads 203 of the end-piece 11 cooperate with threads 403 on the cap 4, which also has, on the inner face of its upper part, an annular sealing lip 404 for sealed closure of the capillary end-piece 11, the lip 404 surrounding a solid transverse wall constituting the stopper 40. According to FIG. 14, the applicator is similar to that in FIG. 12, except that the reservoir 2 is a flexible tube connected to the flared skirt 200, which is in this case shorter than that in the alternative in FIG. 12. According to FIG. 15, the applicator includes an applicator holder 30 which is not integral with the cap 4; the applicator holder 30, which supports the deformable element 35, is made of a plate 301 on one face of which the element 35 is secured, while the other face of the plate 301 bears a grip 302, the applicator holder 30 thereby constituting a sort of powder puff application. The cap 4 has, on the inner face of its upper part, a central rib 440 intended to cooperate with the grip 302, by means of which the applicator holder 30 is applied on the seat 24 when the cap 4 is screwed on to the upper part of the end-piece 11, by cooperation of the threads 203 and 403 on, respectively, the capillary end-piece 11 and the cap 4; the cap 4 also has, on the inner face of its upper part, an annular sealing lip 404 for sealed closure of the capillary end-piece 11; a transverse plate closes the skirt 200 at its lower part in order to form the reservoir 2. According to FIG. 19, the applicator is of the same type as the applicators described with reference to FIGS. 12 to 15, except that the capillary end-piece 11 is made of semi-rigid material, secured in the neck of the reservoir 2, the capillary end-piece 11 being a component distinct from the reservoir 2, as described with reference to FIGS. 1 to 11.

1a

FIELD OF INVENTION [0001] The present invention relates to biocidal agents designed to protect industrial products against microbial, bacterial, fungal and algal infections. In particular, the present invention relates to co-crystals containing 3-iodopropynyl butylcarbamate (IPBC) and to compositions containing said co-crystals which have improved physical, chemical and workability properties compared with the use of IPBC. DESCRIPTION OF THE STATE OF THE ART [0002] 3-Iodopropynyl butylcarbamate (IPBC) is a biocide used as a preservative, fungicide and algaecide in industrial formulations such as paints and coatings, in metalworking and in the protection and preservation of wood. It is also added to polymer formulations to prevent the growth of fungi and bacteria in products obtained from polymers. It is also present in personal care products and cosmetics to prevent the growth of bacteria and fungi. [0003] In some of its applications, IPBC can be added directly to the formulation concerned at room temperature. However, the compound is difficult to use in industrial products and processes. Its solubility in water is extremely low (156 ppm at 20° C.), and it tends to be uneven and sticky, which makes it unsuitable for automatic manufacturing devices. The product melts at the temperature of 67° C., above which it degrades rapidly. It is therefore considered unusable in compositions which must be used above said temperature. [0004] The product can be prepared with high yields and purity as disclosed in U.S. Pat. No. 6,999,208. [0005] The crystalline and molecular structure of IPBC was described by E. V. Avtomonov et al, Zeitschrifit fuer Naturforschung, B: Chemical Sciences, 52(2), 256-258, 1997. [0006] Co-crystals between IPBC and a second component are not known. [0007] The definition of co-crystal has long been debated in the crystallography sphere. The simplest definition is a crystalline structure consisting of two or more components in a precise stoichiometric ratio, where each component can be an atom, an ion or a molecule (G. P. Stahly et al., A survey of co-crystals reported prior to 2000 , Crystal Growth & Design , 9(10), 4212-4229, 2009). However, this definition includes many types of compounds, such as hydrates, solvates and clathrates, so the definition is sometimes extended by specifying that the components of the co-crystals are solid in their pure forms under room conditions (J. H. ter Horst et al, Discovering new co-crystals, Crystal Growth & Design . 9 (3), 1531-1537, 2009). Another definition present in the literature is that co-crystals consist of two or more components that form a single crystalline structure having unique properties (G. P. Stahly, Diversity in Single- and Multiple-Component Crystals. The Search for and Prevalence of Polymorphs and Cocrystals, Crystal Growth & Design 7(6), 1007-1026, 2007). [0008] Co-crystals are orderly structures, and their components interact through non-covalent interactions, such as hydrogen bonds, ionic interactions, van der Waals interactions and π interactions. The properties of co-crystals, such as their melting point, solubility, chemical stability and mechanical properties, differ from those of their individual components. [0009] The formation of co-crystals wherein one of the components is a substance with biological activity is an increasingly common approach in the pharmaceutical industry, because it allows the chemico-physical properties of the active ingredient of interest to be optimised. See, for example: M. J. Zaworokto et al, The role of cocrystals in pharmaceutical science, Drug Discovery Today, 13, 440, 2008; O. Almarsson et al, Crystal engineering of the composition of pharmaceutical phases. Do pharmaceutical cocrystals represent a new path to improved medicines? Chem. Comm., 1889, 2004; P. Vishweshwar et al, Pharmaceutical cocrystals. J. Pharm. Sciences, 95, 499, 2006; A. V. Trask, An overview of pharmaceutical cocrystals as intellectual property. Mol. Pharma. 4, 30, 2007; W. Jones et al., Pharmaceutical cocrystals: an emerging approach to physical property enhancement. MRS Bull. 31, 875, 2006. [0010] Examples of co-crystallisation approaches used to generate new supramolecular materials are reported in US2011152266 (A1), GB2476202 (A), CA2738866 (A1), WO2011035456 (A1), KR20100091127 (A), WO2010011926 (A2), WO2010128977 (A1), MX2008015937 (A), KR20090015912 (A), WO2009116055 (A1), US2009247749 (A1), WO2008108639 (A1), US2008280858 (A1), WO2008021559 (A2), WO2007067727 (A2), US2006149521 (A1), CN1757780 (A) and WO2005089375 (A2). In all cases, the co-crystals are formed by non-covalent interactions involving hydrogen bonds, π-π (stacking) interactions or ion-π interactions. [0011] Methods for generating new molecular entities involving IPBC are described in US20040143011A1 and US7851516B2. However, these documents do not suggest the formation of co-crystals involving the iodoacetylenyl group and halogen bond interaction like those forming the object of the present application. DEFINITIONS [0012] For the purpose of the present application, “co-crystal” is defined as a crystal that contains in the crystal unit cell at least one molecule of IPBC and at least one molecule of a second compound, called the “co-crystallisation agent”, which can be liquid or solid at room temperature. [0013] For the purpose of the present application, the term “halogen bond” (XB) indicates a non-covalent interaction involving the iodine atom of IPBC, which acts as electron density acceptor. This type of bond is indicated in the present application by the graphical representation D - - - I, wherein I is the iodine atom (Lewis acid, electron acceptor, XB-donor) and D is an electron-donor species (Lewis base, XB-acceptor). For a discussion of the halogen bond, see P. Metrangolo, F. Meyer, T. Pilati, G. Resnati, G. Terraneo, Halogen Bonding in Supramolecular Chemistry, Angewandte Chemie International Edition, Volume 47(33), 6114-6127, 2008. DISCLOSURE OF THE INVENTION [0014] The object of the present invention is co-crystals of the compound 3-iodopropynyl butylcarbamate with a co-crystallisation agent, wherein said agent is in the liquid or solid state at room temperature and is bonded to IPBC via at least one halogen bond. The co-crystals according to the invention have more advantageous chemico-physical properties than IPBC, such as better water solubility, greater heat stability, better powder flowability and better compressibility for tablet formation. [0015] The co-crystals according to the invention are obtained by synthesis in the solid state or in solution. They can be formed by a supramolecular approach involving assembly of IPBC with selected chemical species called co-crystallisation agents, which are able to establish non-covalent interactions involving the iodine atom (halogen bond, XB) present on the molecular structure of IPBC. The co-crystallisation agents used in the present invention are: organic bases, in particular aliphatic amines or aromatic heterocyclic derivatives containing at least one basic nitrogen atom; halides; phosphates; and carboxylates. [0016] A further object of the invention is a composition containing a co-crystal as defined above, and additives. [0017] A further object of the invention is the use of a co-crystal as defined above, or a composition as defined above, as a biocide, in particular as a preservative, antibacterial, fungicide or algaecide. [0018] A further object of the invention is industrial products containing a co-crystal as defined above. [0019] Finally, a further object of the invention is a process for the preparation of a co-crystal as defined above, comprising: a) placing IPBC in contact with a co-crystallisation agent able to form at least one halogen bond with said IPBC, under crystallisation conditions such as to form a solid phase wherein the IPBC and said agent are bonded together via at least one halogen bond; and b) optional isolation of the co-crystals formed in step a). DETAILED DESCRIPTION OF THE INVENTION [0020] In one embodiment of the invention the co-crystallisation agent is selected from aromatic heterocycles containing at least one basic nitrogen atom, and is preferably selected from pyridine, pyrimidine, pyrazine, pyridazine, pyrazole, thiazole, isothiazole, oxazole, isoxazole; their derivatives functionalized with C 1 -C 6 alkyl; C 2 -C 6 alkenyl; C 2 -C 6 alkyl groups containing an epoxy group; C 3 -C 7 cycloalkyl groups; benzyl groups; C 6 -C 10 aryl groups; C 1 -C 6 alkoxyl groups; halides; carboxyamide; carbonyl optionally in the form of an acetal or a ketal deriving from a C 1 -C 6 alcohol or optionally in the form of a cyclic ketal deriving from a C 2 -C 6 alkane-1,2-diol or a C 2 -C 6 alkane-1,3-diol; hydroxyl; C 1 -C 6 -alkoxycarbonyl groups; sulfhydryl; C 1 -C 6 alkylthio groups; C 1 -C 6 -alkylsulfinyl groups; C 1 -C 6 -alkylsulfonyl groups; sulfonamide; and benzocondensed derivatives thereof, such as quinoline and isoquinoline. [0021] In one embodiment said aromatic heterocycles useful as co-crystallisation agents are selected from pyridine and derivatives of pyridine of general formula (I) [0000] [0022] wherein L is selected from —(CH 2 ) n —, wherein n is 0 or an integer between 1 and 6, and —C(O)—NH—(CH 2 ) m —NH—C(O)—, wherein m is an integer between 2 and 6, and wherein in said compound (I) one or both pyridine rings can be benzocondensed. [0023] In a preferred embodiment the compounds of formula (I) are selected from 4,4′-bipyridyl, 4-[2-(4-pyridinyl)ethyl]pyridine and N,N′-bis(4-pyridylcarbonyl)-1,6-hexanediamine. [0024] In another embodiment of the invention the co-crystallisation agent is an aliphatic amine of formula R 1 R 2 R 3 N wherein R 1 , R 2 and R 3 are independently selected from the group containing hydrogen, C 1 -C 6 alkyl and C 3 -C 7 cycloalkyl; or R 1 is as defined above and R 2 and R 3 , taken together with the nitrogen atom to which they are bonded, form a 4-7 member nitrogenous heterocyclic ring optionally containing one oxygen or sulphur atom or a further nitrogen atom, said further nitrogen atom being substituted by an R 1 group as defined above; or the aliphatic amines are selected from the group of bicyclic tertiary amines of formula (II) [0000] [0000] wherein p, q and r are independently selected from the integers 2 or 3. [0025] Examples of aliphatic amines useful for the purposes of the present invention are triethylamine, diisopropylethylamine, tributylamine, N-methylpiperidine, N-methylmorpholine and N,N′-dimethylpiperazine. In a preferred embodiment the bicyclic tertiary amine of formula (II) is 1,4-diazabicyclo[2.2.2]octane. [0026] In another embodiment of the invention, the co-crystallisation agent is an organic or inorganic halide. [0027] When an organic halide is used, it is preferably a tetraalkyl ammonium halide of formula R 4 N + X − wherein each R can independently be a C 1 -C 6 alkyl and X − is a halide. [0028] In a preferred embodiment the organic halide is tetrabutyl ammonium halide, preferably tetrabutyl ammonium chloride or tetrabutyl ammonium iodide. [0029] In another embodiment of the invention, the co-crystallisation agent is an inorganic halide, and is preferably an alkali or alkaline-earth metal or transition metal halide selected from iron and zinc, or a tin halide. Examples of inorganic halides usable as co-crystallisation agents according to the present invention are iodides such as cuprous iodide and potassium iodide; chlorides such as ammonium chloride, magnesium chloride, potassium chloride, stannous chloride, calcium chloride, ferric chloride, sodium chloride and zinc (II) chloride. [0030] In a preferred embodiment the inorganic halide is calcium chloride or zinc (II) chloride. [0031] In another embodiment of the invention, the co-crystallisation agent is an inorganic phosphate, such as monobasic ammonium phosphate, dibasic ammonium phosphate, dibasic magnesium phosphate, tribasic magnesium phosphate, monobasic calcium phosphate, dibasic calcium phosphate, tribasic calcium phosphate, calcium pyrophosphate, ferric phosphate, ferric pyrophosphate, monobasic potassium phosphate, dibasic potassium phosphate, tribasic potassium phosphate, potassium pyrophosphate, sodium aluminium phosphate, monobasic sodium phosphate, dibasic sodium phosphate, tribasic sodium phosphate or sodium pyrophosphate. [0032] In another embodiment of the invention the co-crystallisation agent is an alkali or alkaline-earth metal or transition metal carboxylate. Examples of carboxylates useful for the purpose of the present invention are acetates, such as calcium acetate, sodium acetate and zinc acetate; citrates, such as ammonium citrate, calcium citrate, iron (III) citrate, ammonium iron (III) citrate, sodium citrate and potassium citrate; and benzoates, such as sodium benzoate. [0033] In the co-crystals according to the invention, IPBC and the co-crystallisation agent are present in a molar ratio ranging between 2:1 and 4:1. [0034] The preferred co-crystals according to the invention are: co-crystal containing 3-iodopropynyl butylcarbamate and pyridine in a 1:1 molar ratio; co-crystal containing 3-iodopropynyl butylcarbamate and 4-[2-(4-pyridinyl)ethyl]pyridine in a 2:1 molar ratio; co-crystal containing 3-iodopropynyl butylcarbamate and 4,4′-bipyridine in a 2:1 molar ratio; co-crystal containing 3-iodopropynyl butylcarbamate and 1,4-diazabicyclo[2.2.2]octane in a 2:1 molar ratio; co-crystal containing 3-iodopropynyl butylcarbamate and tetrabutyl ammonium iodide in a 3:1 molar ratio; co-crystal containing 3-iodopropynyl butyl carbamate and tetrabutyl ammonium chloride in a 2:1 molar ratio; co-crystal containing 3-iodopropynyl butylcarbamate and calcium chloride in a 4:1 molar ratio; co-crystal containing 3-iodopropynyl butylcarbamate and zinc chloride in a 4:1 molar ratio co-crystal containing 3-iodopropynyl butylcarbamate and N,N′-bis(4-pyridylcarbonyl)-1,6-hexanediamine in a 2:1 molar ratio. [0044] Further preferred co-crystals according to the invention are: co-crystal containing 3-iodopropynyl butylcarbamate and 4-[2-(4-pyridinyl)ethyl]pyridine in a 2:1 molar ratio, having characteristic X-ray powder diffraction (XRPD) peaks at 2θ angle values of 5.12, 5.68, 11.44, 16.95, 22.22, 22.66, 24.97 and 27.88±0.05°, and unit cell dimensions [a=30.666(3) b=4.9869(4) c=21.068(2)] and [α=90.00 β=92.115(6) γ=90.00]; co-crystal containing 3-iodopropynyl butylcarbamate and 4,4′-bipyridine in a 2:1 molar ratio, having characteristic X-ray powder diffraction (XRPD) peaks at 2θ angle values of 6.23 and 21.93±0.05°, and unit cell dimensions a=28.683(2) b=4.9270(4) c=21.429(2)] and [α=90.00 β=99.92(2) γ=90.00]; co-crystal containing 3-iodopropynyl butylcarbamate and tetrabutyl ammonium iodide in a 3:1 molar ratio, having characteristic X-ray powder diffraction (XRPD) peaks at 2θ angle values of 9.28, 14.48, 16.32, 17.73, 20.25, 20.69, 21.10, 21.33, 22.26, 22.90, 23.60, 23.97, 24.30, 25.01, 26.13, 26.51, 27.90 and 28.40±0.1°, and unit cell dimensions [a=10.7688(9) b=20.204(2) c=23.735(2)] and [α=90.00 β=94.778(2) γ=90.00]; co-crystal containing 3-iodopropynyl butylcarbamate and calcium chloride in a 4:1 molar ratio, having characteristic X-ray powder diffraction peaks (XRPD) at 2θ angle values of 9.67 and 22.28±0.05°; co-crystal containing 3-iodopropynyl butylcarbamate and N,N′-bis(4-pyridylcarbonyl)-1,6-hexanediamine in a 2:1 molar ratio, having characteristic X-ray powder diffraction (XRPD) peaks at 2θ angle values of 11.83 and 22.78±0.05°, and unit cell dimensions [a=29.4501(18) b=5.1100(3) c=27.9417(17)] and [α=90.00 β=118.566(3) γ=90.00]; co-crystal containing 3-iodopropynyl butylcarbamate and pyridine in a 1:1 molar ratio, having a 13 C-NMR spectrum substantially as depicted in FIG. 20 wherein the chemical shift may vary from 4.00 ppm up to 14 ppm; co-crystal containing 3-iodopropynyl butylcarbamate and 1,4-diazabicyclo[2.2.2]octane (DABCO) in a 2:1 molar ratio, having an orthorhombic unit cell, Pccn, a: 9.8955(7); b: 31.623(2); c: 8.9335(6) and V=2795.55 A 3 ; co-crystal containing 3-iodopropynyl butylcarbamate and tetrabutylammonium chloride in a 2:1 molar ratio, having an IR spectrum substantially as depicted in FIG. 22 ; co-crystal containing 3-iodopropynyl butylcarbamate and zinc chloride in a 4:1 molar ratio, having a DSC plot substantially as depicted in FIG. 23 , showing two peaks at 118° C. and 139° C. [0054] “Characteristic peaks in the XRPD spectrum” means peaks with a relative intensity exceeding 40% compared with the peak of greatest intensity, taken as 100. [0055] The crystallisation methods used to prepare the co-crystals according to the invention comprise slow and fast evaporation of solutions containing IPBC and the co-crystallisation agent in the desired stoichiometric ratios, wherein the formation of the co-crystal takes place in solution by slow and fast evaporation of the solvent; fast precipitation from quasi-saturated solvent solutions containing IPBC and the co-crystallisation agent; grinding (dry or in the presence of drops of solvent) of a mixture of IPBC and the co-crystallisation agent; melting of the mixture of IPBC and the co-crystallisation agent; mechano-chemical solid-phase synthesis in a ball mill; or a combination of said methods. The choice of one or more of said methods is made on the basis of the physical state (solid or liquid) of the IPBC and/or the co-crystallisation agent at the temperature at which the formation of the co-crystal is conducted. [0056] In one embodiment of the invention, the co-crystals are synthesised in solution. [0057] If both IPBC and the co-crystallisation agent are in the solid state, each substance, in the exact molar ratios, is dissolved separately in a suitable solvent, such as methanol, ethanol, chloroform, dichloromethane, acetonitrile or ethyl acetate. The two solutions are then mixed together, and the resulting mixture is left to evaporate. The evaporation is performed slowly if a single crystal is to be obtained or rapidly, for example with the aid of a vacuum evaporation system, if the co-crystal is to be obtained in powder form. [0058] However, if the co-crystallisation agent is a liquid, a quasi-saturated solution of IPBC is prepared in a suitable solvent, such as methanol, ethanol, chloroform, dichloromethane, acetonitrile or ethyl acetate. The liquid co-crystallisation agent is then added to said solution in an exact molar ratio. The resulting mixture is left to evaporate. The evaporation is performed slowly if a single crystal is to be obtained or rapidly, for example with the aid of a vacuum evaporation system, if the co-crystal is to be obtained in powder form. [0059] In another embodiment of the invention, the co-crystals are synthesised in the solid state. IPBC and the co-crystallisation agent, weighed in the exact molar ratio desired for the co-crystal, are mixed together and placed in a metal container of various dimensions. One or more metal balls of various dimensions are introduced into the container. The container is placed in a ball mill and vibrated with a frequency of 10-30 Hz for a time ranging between 5 and 30 minutes, depending on the dimensions of the container. The product recovered from the container is the co-crystal, which requires no further purification. [0060] The co-crystals according to the invention containing IPBC are suitable to protect industrial materials such as adhesives, glues, paper, cardboard, leather, wood and wood-based materials, coating materials, paints, plastic materials, industrial coolants, industrial lubricants, metalworking fluids, body care products such as wet wipes, toilet paper, cosmetics, and other materials which can be infested or decomposed by micro-organisms. Examples of micro-organisms which can cause the degradation or deterioration of industrial materials, against which the co-crystals according to the invention can be advantageously used, are bacteria, fungi (in particular fungi and moulds that attack wood), yeasts, algae and mucous organisms such as slime. Specific examples are micro-organisms of the genus Alternaria , such as Alternaria tenuis, Aspergillus , such as Aspergillus niger, Chaetomium , such as Chaetomium globosum, Coniophora , such as Coniophora puetana, Lentinus, such as Lentinus tigrinus, Penicillium , such as Penicillium glaucum, Polyporus , such as Polyporus versicolor, Aureobasidium , such as Aureobasidium pullulans, Sclerophoma , such as Sclerophoma pityophila, Trichoderma , such as Trichoderma viride, Escherichia , such as Escherichia coli, Pseudomonas , such as Pseudomonas aeruginosa , and Staphylococcus , such as Staphylococcus aureus. [0061] Depending on their chemico-physical properties, the co-crystals according to the invention can be incorporated in formulations such as solutions, emulsions, suspensions, powders, foams, pastes, granules, tablets and inhalers, or microencapsulated in polymers. The formulations according to the invention can be prepared by conventional methods. For example, the formulations can be prepared by mixing the co-crystals with diluents, such as liquid solvents or gases liquefied under pressure, and/or with solid diluents, if necessary also using surfactants, such as emulsifying agents and/or dispersing agents and/or foaming agents. If the diluent used is water, organic solvents can also be used as co-solvents. The solvents usable are aromatic solvents such as toluene and xylene; chlorinated aliphatic or aromatic hydrocarbons such as dichloromethane and chlorobenzene; aliphatic hydrocarbons such as cyclohexane; alcohols such as butanol, ethylene glycol and their ethers and esters; ketones such as acetone and ethyl methyl ketone, or cyclohexanone; highly polar solvents such as water, dimethyl sulphoxide and dimethylformamide. Examples of gases liquefied under pressure are liquids which are gaseous at room pressure and temperature, such as halogenated hydrocarbons, butane, propane, nitrogen and carbon dioxide. [0062] Suitable solid diluents are pulverised natural or synthetic minerals such as kaolins, clays, talc, gypsum, quartz, fossil flours, and silica, alumina and silicate powders. [0063] Suitable emulsifying and/or foaming agents are, for example, non-ionic or anionic emulsifying agents such as polyoxyethylene esters with fatty acids, ethers between polyoxyethylene and fatty alcohols, alkyl- or aryl-sulphonates, and alkylsulphates. An example of a suitable dispersing agent is methylcellulose. [0064] The formulations generally contain between 0.1% and 95% by weight of the co-crystals, preferably between 2% and 75% by weight. [0065] A further object of the present invention is therefore compositions with a biocidal activity containing a co-crystal of IPBC according to the invention and at least one solvent or diluent. The compositions according to the invention can also contain additives which assist the process of obtaining the composition and, if necessary, other biocidal agents such as agents with an antimicrobial, fungicidal, bactericidal, herbicidal, insecticidal or algaecidal activity. In this case, the co-crystals according to the invention and the other biocidal agents can be present in solution, suspension or emulsion. The solvents or diluents can be water or conventional organic solvents. Compositions containing a co-crystal according to the invention and another biocidal agent as active ingredients can present a broader action spectrum than the individual active ingredients and/or a synergic effect. Examples of other biocidal agents which can be present in the compositions according to the invention include azaconazole, bromuconazole, cyproconazole, dichlorobutrazole, diniconazole, diuron, hexaconazole, metconazole, penconazole, propiconazole, tebuconazole, dichlofluanid, tolylfluanid, fluorfolpet, methfuroxam, carboxin, cyclohexyl-benzo[b]thiophene carboxamide S,S-dioxide, fenpiclonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, butenafine, imazalil, N-methyl-isothiazolin-3-one, 5-chloro-N-methyl-isothiazolin-3-one, N-octyl-isothiazolin-3-one, dichloro-N-octyl-isothiazolinone, mercaptobenzothiazole, thiocyano-methylthiobenzothiazole, tiabendazole, benzisothiazolinone, N-(2-hydroxypropyl)aminomethanol, benzyl hemiformal, N-methylol-chloroacetamide, N-(2-hydroxypropyl)aminomethanol, glutaraldehyde, omadine, Zn-omadine, dimethyl dicarbonate, 2-bromo-2-nitro-1,3-propanediol, bethoxazin, o-phthaldialdehyde, 2,2-dibromo-3-cyano-propionamide, 1,2-dibromo-2,4-dicyano-butane, 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH), tetramethylolacetylenediurea (TMAD), ethylene glycol hemiformal, p-hydroxybenzoic acid and p-hydroxybenzoic acid esters (parabens), such as ethyl p-hydroxybenzoate (E214), ethyl-p-hydroxybenzoate sodium salt (E215), propyl p-hydroxybenzoate (E216), propyl p-hydroxybenzoate sodium salt (E217), methyl-p-hydroxybenzoate (E218) and methyl-p-hydroxybenzoate sodium salt (E219), carbendazim, chlorophene, 3-methyl-4-chlorophenol and o-phenylphenol. [0066] The weight ratio between the co-crystals of the invention and the other biocidal agents can vary within a wide range. Said ratio preferably ranges between 50:1 and 1:50. [0067] The compositions with antimicrobial activity of the invention contain the co-crystals of the invention or a mixture of the co-crystals of the invention and another biocidal agent in a concentration of between 0.1% and 95% by weight, preferably between 0.1% and 60% by weight. [0068] The concentrations at which the co-crystals of the invention or their combination with another biocidal agent are used depend on the nature and incidence of the micro-organisms to be controlled, and the composition of the material to be protected. The ideal quantity for use can be determined by a series of tests. In general, for most applications the concentration is between 0.001% and 5% by weight, preferably between 0.05% and 2% by weight, depending on the material to be protected. [0069] Compositions containing the co-crystals of the invention have better physical and chemical properties (such as greater solubility in water and greater heat stability) and workability properties (such as better powder flowability and better compressibility for tablet formation) than compositions containing IPBC. [0070] A further object of the invention is therefore the use of a co-crystal or composition of the invention as biocide in industrial products, in particular as a preservative, antibacterial, fungicide or algaecide, especially in paints, coatings, metalworking fluids, protection and preservation of wood, and in body care products or cosmetic formulations. DESCRIPTION OF FIGURES [0071] FIG. 1 : Graphical representation of the co-crystal of example 1. [0072] FIG. 2 : IR spectrum of the co-crystal of example 1. [0073] FIG. 3 : XRPD tracing of the co-crystal of example 1. [0074] FIG. 4 : DSC tracing of the co-crystal of example 1. [0075] FIG. 5 : Graphical representation of the co-crystal of example 2. [0076] FIG. 6 : IR spectrum of the co-crystal of example 2. [0077] FIG. 7 : XRPD tracing of the co-crystal of example 2. [0078] FIG. 8 : DSC tracing of the co-crystal of example 2. [0079] FIG. 9 : Graphical representation of the co-crystal of example 3. [0080] FIG. 10 : API IR spectrum of the co-crystal of example 3. [0081] FIG. 11 : XRPD tracing of the co-crystal of example 3. [0082] FIG. 12 : DSC tracing of the co-crystal of example 3. [0083] FIG. 13 : API IR spectrum of the co-crystal of example 4. [0084] FIG. 14 : XRPD tracing of the co-crystal of example 4. [0085] FIG. 15 : DSC tracing of the co-crystal of example 4. [0086] FIG. 16 : Graphical representation of the co-crystal of example 5. [0087] FIG. 17 : API IR spectrum of the co-crystal of example 5. [0088] FIG. 18 : XRPD tracing of the co-crystal of example 5. [0089] FIG. 19 : DSC tracing of the co-crystal of example 5. [0090] FIG. 20 : 13 C-NMR of the co-crystal of example 6. [0091] FIG. 21 : Ball and stick representation from single crystal analysis of the co-crystal of example 7. DABCO hydrogen atoms are omitted for clarity. [0092] FIG. 22 : IR spectrum of the co-crystal of example 8. [0093] FIG. 23 : DSC plot of the co-crystal of example 9. [0094] FIG. 24 : Pictures of cones of pure IPBC (A, C) and co-crystal (IPBC) 4 :CaCl 2 (B, D) powders, taken after flowing the powders through the funnel. [0095] The invention will now be illustrated by the following examples. EXAMPLES Materials and Methods [0096] The IR spectra were obtained with a Nicolet Nexus FTIR spectrophotometer equipped with the U-ATR device. The values are reported as wave numbers, and are rounded to 1 cm −1 after automatic assignment. The melting points were obtained by differential scanning calorimetry (DSC, Mettler Toledo 823e). [0097] Single-Crystal X-Ray Diffraction The data were collected at different temperatures with a Bruker KAPPA APEX II diffractometer with Mo-Kα radiation (λ=0.71073) and a CCD detector. The Bruker KRYOFLEX device was used for the low-temperature acquisitions. The structures were resolved and refined with the SIR2004 and SHELXL-97 programs respectively. The refinement was performed by the full-matrix least squares method on F 2 . The hydrogen atoms were placed using standard geometric models and with their thermal parameters based on those of their geminal atoms. [0098] X-Ray Powder Diffraction [0099] The X-ray powder diffraction experiments were conducted with a Bruker D8 Advance diffractometer operating in reflection mode with Ge-monochromatic Cu Kα1 radiation (λ=1.5406 Å) and with a position-sensitive linear detector. The powder diffraction data was collected at room temperature with a 20 interval of 5-40°, using increments of 0.016° and an exposure time of 1.5 s per increment. Example 1 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and 4-[2-(4-Pyridinyl)Ethyl]pyridine in a 2:1 Molar Ratio (Co-Crystal 1) [0100] [0101] This example demonstrates the ability of IPBC to co-crystallise with a neutral aromatic amine able to act as halogen bond acceptor, such as 4-[2-(4-pyridinyl)ethyl]pyridine. [0102] Rapid precipitation of the two compounds in a quasi-saturated acetonitrile solution leads to the formation of a solid white powder with a melting point of between 81° C. and 83° C. [0103] Single-crystal X-ray diffraction demonstrates that in the co-crystal, IPBC and 4-[2-(4-pyridinyl)ethyl]pyridine are present in a molar ratio of 2:1, as shown in FIG. 1 . The basic structural pattern in the co-crystal is a trimer unit wherein 4-[2-(4-pyridinyl)ethyl]pyridine acts as bridge between two IPBC molecules via two halogen bonds I - - - N. [0104] The dimensions and angles of the crystallographic unit cell are [a=30.666(3) b=4.9869(4) c=21.068(2)] and [α=90.00 β=92.115(6) γ=90.00] respectively. [0105] The IR spectrum of the co-crystal and its characteristic bands are reported in FIG. 2 . [0106] FIG. 3 shows the X-ray powder diffraction (XRPD) of the co-crystal, the main peaks of which, in the 5-40° 2θ value range, are shown in Table 1. [0107] The DSC thermogram of co-crystal 1 is reported in FIG. 4 . [0000] TABLE 1 Angle(2θ)* d (Å) Intensity % 2th = 5.117° 17.25577 2521 51.2 2th = 5.684° 15.53601 4923 100.0 2th = 8.644° 10.22081 1240 25.2 2th = 8.924° 9.90129 1792 36.4 2th = 9.274° 9.52842 907 18.4 2th = 11.445° 7.72521 3010 61.1 2th = 12.225° 7.23443 490 10.0 2th = 14.471° 6.11592 932 18.9 2th = 15.726° 5.63077 310 6.3 2th = 16.087° 5.50517 408 8.3 2th = 16.402° 5.40011 592 12.0 2th = 16.951° 5.22630 2000 40.6 2th = 17.228° 5.14312 872 17.7 2th = 17.997° 4.92493 576 11.7 2th = 18.382° 4.82269 644 13.1 2th = 19.133° 4.63491 368 7.5 2th = 19.692° 4.50459 476 9.7 2th = 20.105° 4.41308 507 10.3 2th = 21.176° 4.19213 350 7.1 2th = 21.524° 4.12518 1449 29.4 2th = 21.800° 4.07364 894 18.2 2th = 22.221° 3.99734 4665 94.8 2th = 22.663° 3.92047 2184 44.4 2th = 23.181° 3.83400 1450 29.5 2th = 24.580° 3.61886 373 7.6 2th = 24.967° 3.56356 2850 57.9 2th = 25.348° 3.51083 400 8.1 2th = 25.876° 3.44043 339 6.9 2th = 26.404° 3.37283 302 6.1 2th = 27.191° 3.27701 783 15.9 2th = 27.882° 3.19725 4091 83.1 2th = 28.258° 3.15564 451 9.2 2th = 28.838° 3.09341 1892 38.4 2th = 29.185° 3.05747 373 7.6 2th = 30.311° 2.94642 344 7.0 2th = 30.988° 2.88354 260 5.3 2th = 32.914° 2.71904 255 5.2 2th = 33.516° 2.67160 361 7.3 2th = 34.345° 2.60901 250 5.1 2th = 34.793° 2.57641 883 17.9 2th = 35.051° 2.55803 443 9.0 2th = 35.850° 2.50285 270 5.5 2th = 36.589° 2.45396 519 10.5 2th = 37.072° 2.42311 464 9.4 2th = 37.905° 2.37175 254 5.2 2th = 38.291° 2.34872 309 6.3 2th = 39.015° 2.30676 228 4.6 2th = 39.738° 2.26645 438 8.9 *Values ± 0.05° [0108] The co-crystal thus obtained has a higher melting point, higher thermal stability, better workability and higher degree of crystallinity than IPBC. It is easily manageable in the operations required to form tablets, such as compression. Example 2 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and 4,4′-Bipyridine in a 2:1 Molar Ratio (Co-Crystal 2) [0109] [0110] This example demonstrates the ability of IPBC to co-crystallise with another neutral aromatic amine able to act as halogen bond acceptor, such as 4,4′-dipyridine. [0111] In this case the formation of the co-crystal was effected by slow precipitation from an ethanol solution, which leads to the formation of a white powder. [0112] The basic structural motif in the co-crystal is a trimeric unit, bonded via halogen bonds, consisting of one molecule of 4,4′-bipyridine and two molecules of IPBC, as shown in FIG. 5 . [0113] The co-crystal is a solid crystalline product with a melting point of between 112° C. and 114° C. The dimensions and angles of the crystallographic unit cell are [a=28.683(2) b=4.9270(4) c=21.429(2)] and [α=90.00 β=99.92(2) γ=90.00] respectively. [0114] The IR spectrum of the co-crystal and its characteristic bands are reported in FIG. 6 . [0115] FIG. 7 shows the X-ray powder diffraction (XRPD) of the co-crystal, the main peaks of which, in the 5-40° 2θ value range, are shown in Table 2. [0116] The DSC thermogram of co-crystal 2 is reported in FIG. 8 . [0000] TABLE 2 Angle(2θ)* d (Å) Intensity % 2th = 6.234° 14.16728 8558 100.0 2th = 8.358° 10.57069 353 4.1 2th = 9.560° 9.24440 679 7.9 2th = 12.160° 7.27286 269 3.1 2th = 12.521° 7.06371 1737 20.3 2th = 13.187° 6.70850 197 2.3 2th = 13.841° 6.39289 399 4.7 2th = 16.255° 5.44854 2148 25.1 2th = 16.825° 5.26536 663 7.7 2th = 18.651° 4.75371 507 5.9 2th = 18.861° 4.70134 1402 16.4 2th = 19.248° 4.60750 1051 12.3 2th = 19.892° 4.45974 187 2.2 2th = 20.400° 4.34990 797 9.3 2th = 21.931° 4.04952 5931 69.3 2th = 22.695° 3.91488 453 5.3 2th = 23.110° 3.84554 991 11.6 2th = 23.835° 3.73028 1084 12.7 2th = 24.461° 3.63616 319 3.7 2th = 24.826° 3.58348 679 7.9 2th = 25.194° 3.53200 3287 38.4 2th = 26.333° 3.38179 452 5.3 2th = 27.465° 3.24488 325 3.8 2th = 27.980° 3.18637 877 10.2 2th = 28.475° 3.13207 786 9.2 2th = 28.928° 3.08399 349 4.1 2th = 29.463° 3.02919 427 5.0 2th = 29.735° 3.00209 298 3.5 2th = 30.264° 2.95086 255 3.0 2th = 30.571° 2.92189 319 3.7 2th = 31.311° 2.85455 198 2.3 2th = 32.653° 2.74021 176 2.1 2th = 33.314° 2.68732 203 2.4 2th = 33.439° 2.67760 232 2.7 2th = 33.914° 2.64116 241 2.8 2th = 34.205° 2.61934 475 5.6 2th = 34.762° 2.57862 234 2.7 2th = 36.146° 2.48303 206 2.4 2th = 37.672° 2.38589 384 4.5 2th = 38.213° 2.35331 596 7.0 2th = 38.614° 2.32980 258 3.0 *Values ± 0.05° [0117] The co-crystal thus obtained has a higher melting point, higher thermal stability, better workability and higher degree of crystallinity than IPBC. It is easily manageable in the operations required to form tablets, such as compression. Example 3 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and Tetrabutyl Ammonium Iodide in a 3:1 Molar Ratio (Co-Crystal 3) [0118] [0119] This example demonstrates the ability of IPBC to co-crystallise with a halide deriving from an organic salt such as tetrabutylammonium iodide. [0120] The co-crystal was formed by mechano-chemical synthesis in a ball mill, using a stoichiometric ratio of 1:3 between tetrabutyl ammonium iodide and IPBC. [0121] The co-crystal obtained contains one molecule of tetrabutyl ammonium iodide and three molecules of IPBC, as shown in the graphical representation in FIG. 9 . [0122] The co-crystal is a solid crystalline product with a melting point between 42° C. and 47.5° C. The dimensions and angles of the crystallographic unit cell are a=10.7688(9) b=20.204(2) c=23.735(2)] and [α=90.00 β=94.778(2) γ=90.00] respectively. [0123] The IR spectrum of the co-crystal and its characteristic bands are reported in FIG. 10 . [0124] FIG. 11 shows the X-ray powder diffraction (XRPD) of the co-crystal, the main peaks of which, in the 5-40° 2θ value range, are shown in Table 3. [0125] The DSC thermogram of co-crystal 3 is reported in FIG. 12 . [0000] TABLE 3 Angle(2θ)* d (Å) Intensity % 2th = 9.285° 9.51690 513 53.5 2th = 14.485° 6.11006 445 46.5 2th = 16.322° 5.42635 469 49.0 2th = 17.432° 5.08330 346 36.1 2th = 17.729° 4.99868 537 56.1 2th = 18.440° 4.80755 373 38.9 2th = 20.246° 4.38272 517 54.0 2th = 20.698° 4.28791 438 45.7 2th = 21.072° 4.21276 423 44.2 2th = 21.331° 4.16217 629 65.7 2th = 22.261° 3.99035 958 100.0 2th = 22.903° 3.87977 590 61.6 2th = 23.605° 3.76596 613 64.0 2th = 23.968° 3.70974 484 50.5 2th = 24.305° 3.65910 616 64.3 2th = 25.009° 3.55775 580 60.5 2th = 25.670° 3.46761 363 37.9 2th = 26.129° 3.40770 406 42.4 2th = 26.507° 3.35996 423 44.2 2th = 26.730° 3.33240 343 35.8 2th = 27.359° 3.25726 326 34.0 2th = 27.893° 3.19608 432 45.1 2th = 28.399° 3.14030 389 40.6 2th = 28.918° 3.08502 372 38.8 2th = 30.514° 2.92722 311 32.5 2th = 31.221° 2.86256 302 31.5 2th = 31.654° 2.82441 322 33.6 2th = 32.085° 2.78741 349 36.4 2th = 32.592° 2.74517 308 32.2 2th = 33.490° 2.67360 323 33.7 2th = 34.033° 2.63217 246 25.7 2th = 34.608° 2.58975 249 26.0 2th = 34.973° 2.56357 314 32.8 2th = 35.533° 2.52440 269 28.1 2th = 36.332° 2.47069 261 27.2 2th = 36.772° 2.44214 278 29.0 2th = 37.328° 2.40703 225 23.5 2th = 38.414° 2.34144 277 28.9 *Values ± 0.1° [0126] The co-crystal thus obtained has a lower melting point, higher solubility and better workability in an aqueous medium than IPBC. In particular, its aqueous solubility is approx. 40% greater than that of IPBC. Example 4 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and Calcium Chloride in a 4:1 Molar Ratio (Co-Crystal 4) [0127] [0128] This example demonstrates the ability of IPBC to co-crystallise with a halide deriving from an inorganic salt such as calcium chloride. [0129] The co-crystal was formed by mechano-chemical synthesis in a ball mill, using a stoichiometric ratio of 1:4 between calcium chloride and IPBC. [0130] The composition of the co-crystal was detected by analysing the DSC trace, where the presence of peaks of the starting products was not observed. [0131] The co-crystal is a solid crystalline product with a melting point of 83-86° C. [0132] The IR spectrum of the co-crystal and its characteristic bands are reported in FIG. 13 . [0133] FIG. 14 shows the X-ray powder diffraction (XRPD) of the co-crystal, the main peaks of which, in the 5-40° 2θ value range, are shown in Table 4. [0134] The DSC thermogram of co-crystal 4 is reported in FIG. 15 . [0000] TABLE 4 Angle(2θ) d (Å) Intensity % 2th = 6.581° 13.41984 5844 16.2 2th = 7.314° 12.07749 10715 29.7 2th = 8.160° 10.82602 4892 13.6 2th = 9.674° 9.13549 16217 45.0 2th = 11.059° 7.99382 7263 20.1 2th = 11.991° 7.37478 4418 12.3 2th = 13.299° 6.65245 6966 19.3 2th = 15.631° 5.66483 4674 13.0 2th = 15.982° 5.54118 6113 17.0 2th = 17.374° 5.10003 8718 24.2 2th = 18.517° 4.78765 9325 25.9 2th = 19.365° 4.57995 11180 31.0 2th = 20.091° 4.41616 3184 8.8 2th = 21.313° 4.16552 4102 11.4 2th = 22.282° 3.98664 36057 100.0 2th = 23.054° 3.85484 3660 10.2 2th = 23.469° 3.78751 3136 8.7 2th = 24.435° 3.63994 6628 18.4 2th = 24.990° 3.56041 12456 34.5 2th = 26.159° 3.40384 5054 14.0 2th = 26.775° 3.32689 4703 13.0 2th = 27.659° 3.22252 11372 31.5 2th = 28.514° 3.12789 5945 16.5 2th = 29.588° 3.01671 6588 18.3 2th = 30.368° 2.94095 2644 7.3 2th = 31.158° 2.86817 4800 13.3 2th = 31.838° 2.80850 8422 23.4 2th = 32.766° 2.73101 2388 6.6 2th = 33.979° 2.63621 4478 12.4 2th = 34.729° 2.58102 3049 8.5 2th = 35.337° 2.53800 2887 8.0 2th = 36.000° 2.49271 2816 7.8 2th = 36.603° 2.45308 2980 8.3 2th = 37.030° 2.42574 3009 8.3 2th = 37.436° 2.40037 3085 8.6 2th = 38.110° 2.35946 4670 13.0 2th = 38.968° 2.30947 3168 8.8 2th = 39.475° 2.28092 2995 8.3 * Values ± 0.05° [0135] The co-crystal thus obtained has a higher melting point, higher solubility and better workability in an aqueous medium than IPBC. In particular, its aqueous solubility is approx. 50% greater than that of IPBC. Example 5 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and N,N′-Bis(4-Pyridylcarbonyl)-1,6-Hexanediamine in a 2:1 Molar Ratio (Co-Crystal 5) [0136] [0137] In this example, IPBC was co-crystallised with N,N′-bis(4-pyridylcarbonyl)-1,6-hexanediamine by slow evaporation from alcohol solutions and by mechano-chemical synthesis in a ball mill, using a ratio of 1:2 between the co-crystallisation agent and IPBC. [0138] In the co-crystal obtained there is a ratio of 1:2 between the co-crystallisation agent and IPBC, as shown in the graphical representation in FIG. 16 . [0139] The co-crystal is a solid crystalline product with a melting point of 132° C. The dimensions and angles of the crystallographic unit cell are [a=29.4501(18) b=5.1100(3) c=27.9417(17)] and [α=90.00 β=118.566(3) γ=90.00] respectively. [0140] The IR spectrum of the co-crystal and its characteristic bands are reported in FIG. 17 . [0141] FIG. 18 shows the X-ray powder diffraction (XRPD) of the co-crystal, the main peaks of which, in the 5-40° 2θ value range, are shown in Table 5. [0142] The DSC thermogram of co-crystal 5 is reported in FIG. 19 . [0000] TABLE 5 Angle(2θ) d (Å) Intensity % 2th = 5.887° 14.99966 1231 18.2 2th = 6.951° 12.70619 545 8.1 2th = 10.380° 8.51551 690 10.2 2th = 11.831° 7.47444 3530 52.3 2th = 13.013° 6.79759 324 4.8 2th = 13.477° 6.56468 591 8.8 2th = 13.961° 6.33814 1111 16.5 2th = 14.270° 6.20161 272 4.0 2th = 15.441° 5.73399 1653 24.5 2th = 16.713° 5.30018 510 7.6 2th = 17.132° 5.17156 244 3.6 2th = 17.945° 4.93909 411 6.1 2th = 18.816° 4.71240 331 4.9 2th = 19.095° 4.64417 378 5.6 2th = 19.516° 4.54479 300 4.4 2th = 20.075° 4.41964 366 5.4 2th = 20.950° 4.23697 1050 15.6 2th = 21.366° 4.15541 563 8.3 2th = 21.916° 4.05229 740 11.0 2th = 22.784° 3.89988 6751 100.0 2th = 23.513° 3.78060 855 12.7 2th = 23.856° 3.72703 939 13.9 2th = 24.326° 3.65609 332 4.9 2th = 25.096° 3.54550 509 7.5 2th = 25.760° 3.45568 376 5.6 2th = 26.944° 3.30641 653 9.7 2th = 27.924° 3.19254 305 4.5 2th = 28.684° 3.10973 548 8.1 2th = 29.094° 3.06678 276 4.1 2th = 29.709° 3.00471 330 4.9 2th = 30.531° 2.92568 430 6.4 2th = 31.214° 2.86315 419 6.2 2th = 31.568° 2.83188 367 5.4 2th = 32.461° 2.75600 241 3.6 2th = 32.802° 2.72810 284 4.2 2th = 34.124° 2.62537 365 5.4 2th = 34.688° 2.58393 478 7.1 2th = 36.154° 2.48246 505 7.5 2th = 36.966° 2.42976 398 5.9 2th = 37.750° 2.38110 561 8.3 2th = 39.102° 2.30185 457 6.8 * Values ± 0.05° [0143] The co-crystal thus obtained has a higher melting point, higher thermal stability, better workability and higher degree of crystallinity than IPBC. It is easily manageable in the operations required to form tablets, such as compression. Example 6 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and Pyridine in a 1:1 Molar Ratio (Co-Crystal 6) [0144] In this example, IPBC was co-crystallised with pyridine. [0145] The co-crystal was prepared dissolving in the 1:1 molar ratio IPBC in pyridine. [0146] The cocrystal is liquid at room temperature, but the formation of a halogen bonded system between IPBC and pyridine can be confirmed looking at the chemical shift variation of 13 C-NMR for the carbon bound to iodine. [0147] Previous studies have demonstrated that the 13 C signals of the iodinated carbons of iodoethynyl moieties undergo major low-field shifts on changing the solvent from chloroform to dimethylsulphoxide as a consequence of the XB occurring with the oxygen atoms of the solvent. [ref. Rege, P. D.; Malkina, O. L.; Goroff, N. S. J. Am. Chem. Soc. 2002, 124, 370-371. Gao, K.; Goroff, N. S. J. Am. Chem. Soc. 2000, 122, 9320-9321.]. The ≡C—I signals of deuterochloroform solutions of pure IPBC is at 3.68 ppm, in the cocrystal with pyridine the ≡C—I chemical shift varies from 4.00 ppm up to 14 ppm depending of the concentration of pyridine used, as shown in FIG. 20 . Example 7 [0148] Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and 1,4-Diazabicyclo[2.2.2]Octane (DABCO) in a 2:1 Molar Ratio (Co-Crystal 7) [0149] In this example, IPBC was co-crystallised with the bicyclic tertiary amine 1,4-diazabicyclo[2.2.2]octane (DABCO), to give a co-crystal IPBC:DABCO with molar ratio 2:1. [0150] IPBC was co-crystallised with DABCO by slow evaporation from alcohol/haloalkane solutions, using a ratio of 1:2 between the co-crystallisation agent and IPBC. [0151] Melting point: 35-38° C. [0152] The structure of the IPBC.DABCO co-crystal from single crystal crystallographic analysis is shown in FIG. 21 , wherein DABCO hydrogen atoms are omitted for clarity. [0153] Crystallographic data: orthorhombic, Pccn, a: 9.8955(7); b: 31.623(2); c: 8.9335(6) and V=2795.55 A 3 . Example 8 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and Tetrabutylammonium Chloride (TBACl) in a 2:1 Molar Ratio (Co-Crystal 8) [0154] In this example, IPBC was co-crystallised with tetrabutylammonium chloride (TBACl) to give a IPBC:TBACl co-crystal with molar ratio 2:1. [0155] The co-crystal was formed by heating the two components up to 50° C. using a stoichiometric ratio of 1:2 between tetrabutyl ammonium chloride and IPBC. [0156] The co-crystal is liquid at room temperature. [0157] Melting point −15° C. [0158] The formation of a halogen bonded co-crystal between IPBC and TBACl can be confirmed looking at the IR wave number variation for C≡C group. The triple bond stretching band is at 2198 cm −1 in the pure IPBC while it is red-shifted at 2181 cm −1 for the (IPBC) 2 :TBACl cocrystal, as shown in FIG. 22 . Example 9 Co-Crystal Containing 3-Iodopropynyl Butylcarbamate and Zinc Chloride in a 4:1 Molar Ratio (Co-Crystal 9) [0159] This example demonstrates the ability of IPBC to co-crystallise with a halide deriving from a transition metal, such as zinc chloride, to give a IPBC:ZnCl 2 co-crystal with molar ratio 4:1 [0160] The co-crystal was prepared using the same procedure employed for example 4. [0161] The formation of a halogen bonded cocrystal between IPBC and ZnCl 2 can be confirmed looking at the DSC plot ( FIG. 23 ) showing two peaks at 118° C. and 139° C. (mixture of polymorphs) and the absence of the IPBC melting peak. Example 10 Evaluation of Flowing Characteristics of Powders Containing the Halogen Bonded (IPBC) 4 :CaCl 2 Complex or Pure IPBC [0162] In this example the angle of response of powders containing the halogen bonded (IPBC) 4 :CaCl 2 complex of example 4 was compared to that of powders containing pure IPBC ( FIG. 24 ). The angle of response estimates the flow characteristics of the powders, [0163] The use of pure IPBC in industrial products faces significant manufacturing drawbacks. IPBC is difficult to handle because it tends to be clumpy and sticky, this implies that it cannot be fed easily from the blending equipment and the automatic feeding device. [0164] FIG. 24 shows that the cohesive properties of powder for co-crystal (IPBC) 4 :CaCl 2 are drastically different compared to the pure IPBC. Co-crystal (IPBC) 4 :CaCl 2 has values of angle of repose between 13° and 20° which indicates that it has excellent free-flow powder characteristic. On the contrary for the pure IPBC it is impossible to evaluate any angle of repose since the cohesive forces in the powder are too strong and its powder does not form an appropriate cone shape but tends to aggregate in irregular pillared shape. The cylindrical shape of IPBC cones indicates clearly the high cohesion of the powders, while the flat cone shape of co-crystal (IPBC) 4 :CaCl 2 indicates improved flow powder properties.

1a

BACKGROUND OF THE INVENTION The field of the present invention is remote training devices for animals. In the training of animals since the late 1960's, owners/handlers/trainers (hereinafter “user”) have employed various electronic techniques and technologies to encourage and/or discourage an animal's actions. From this, an animal can learn desired behaviors. These electronic aides, whether remotely controlled by the user, manually controlled by sensor inputs or automatically controlled by the animal's own actions, have advanced throughout the years to gain prominence in today's electronic world. Different kinds of electronic cue signals have been employed using varying degrees, or levels, of sounds, vibrations, and electrical impulses. With these tools and through experience gained through the years, focus has been on making these cue signals fit specific events while improving the animal's acceptance in learning its tasks more easily. This experience has been predominately been with dogs; although the application of such devices are not specifically limited only to dogs. During this evolution, manufacturers offered users the capability to select different levels of cue signals at a given moment from a hand-held transmitter to the dog's collar at a distance and from one to over one hundred different levels. From this vantage, what has been learned is that one level is not always the appropriate level. Rather, many levels are useful and depend upon the temperament and distraction level of each individual dog at any given moment. It is advantageous to have the means to quickly adjust the level to match the dog's current focus. Yet, even a selector dial with many levels to select from may not be enough as the available levels may not properly match the dog's adrenal releases and distractions. Therefore a device was needed which provides incremental gradual levels that can be quickly adjusted just as the volume control in ones car radio—fitting the individual's hearing quality while overcoming background noise levels. In this manner, the device's output needs to finitely change to match the dog's adrenaline and background distractions at any given moment and at appropriate distances. Not only to go up in level but to instantly come down in level, therein never overwhelming the dog or causing any over reactions by the dog. SUMMARY OF THE INVENTION The present invention is directed to a remote control for animal training including a remote controller held by a user and a training device worn by an animal coupled by radio frequency (RF) communication. The remote controller has a stimulation mode selection button, a control for setting the level of electrical impulse stimulation to be applied to the animal which includes a three-terminal potentiometer for volume control. A voltage-to-frequency converter converts a voltage level set by the volume control to a corresponding frequency signal proportional to the voltage level. RF communication circuitry transmits signals including the kind and mode of stimuli and the level of electrical impulse stimulation to the training device through a transmitting antenna. Additional features are selectively contemplated including a buzzer and an LED on the training device controlled by the remote controller. Battery charge status of the power sources on the two devices are contemplated for the remote controller. A GPS locator and a detachable antenna are also contemplated. Therefore, it is an object of the present invention to provide an improved animal training device. Other and further objects and advantages will become apparent from the following description. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view showing a remote controller and a training device used in a remote animal training system. FIG. 2 is a block diagram showing the remote controller circuitry according to a first embodiment. FIG. 3 is a block diagram showing the training device according to the first embodiment. FIG. 4 is a block diagram showing the remote controller circuitry according to a second embodiment. FIG. 5 is a block diagram showing the training device according to the second embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A remote control for animal training includes a user hand-held transmitter for transmitting coded command signals. The command signals are transmitted via a microprocessor amplified through a RF system and outputted through an antenna. The remote control further includes a training device worn by the animal to be trained. An RF receiver receives command signals with individual output levels of three different styles of stimuli to the sensory system of the animal in order to allow the animal to properly react or respond to these levels of stimuli. A hand-held transmitter uses a voltage frequency converter (VFC) for converting input from a three-terminal potentiometer voltage to a frequency proportional thereto. The frequency signal is input to a microprocessor. The microprocessor has a security code function to limit control of the training device to that of the remote controller. Five function switches allow for the selection of one of five types of stimulation, 1) brief electrical impulse stimulation, 2) continuous electrical impulse stimulation, 3) boost continuous electrical impulse stimulation, at a preset level above the continuous stimulation setting, 4) magnetic buzzer stimulation, and 5) light stimulation. The switches are connected to the RF circuitry to produce and amplify signals denoting the selected stimulation then delivered to an antenna driver and in turn to a tuned broadcast antenna. An animal collar receiver receives the RF transmitted coded signals from the transmitter. A detector circuit detects the coded signals and sends them to an on-board microprocessor. The microprocessor converts the coded signals and activates one of five driver circuits for then outputting the selected stimuli and the appropriate level to the animal. The same RF circuitry on both the remote controller and the training device can function as paired transceivers to broadcast intelligent data back to the hand-held transmitter. A stimulator adjustment control includes a voltage divider network with a three-terminal potentiometer. The potentiometer is coupled to a voltage to frequency converter circuit (VFC) which converts the voltage level into individual separate frequencies. These separate frequencies allow the microprocessor to send the appropriate signal to the individual stimuli drivers for the five different outputs at the animal collar to articulate many different gradual levels of output from each of the five individually selectable stimuli. Both the transmitter and receiver employee a DC battery pack for operating each system through an on-board regulator and power switch. In one embodiment, rechargeable batteries and their charging circuits are installed. On/off power switches are provided in each the transmitter and the receiver to activate and deactivate each system independently. In one embodiment, an LCD screen is employed in the transmitter and offers the user the capability to observe in a visual display the level setting, the state of the transmitter battery and which one of the five select function buttons is powered up when that particular button is pressed, preferably by icon. With the capability to adjust gradual levels upward and downward while also providing different styles of stimulation, the control offers the animal opportunities to be successful while allowing the user to build a more meaningful relationship with the animal. To allow greater potential for successful training results, these sensory detectors and their drive circuitry would include utilizing optical, photo, infrared, air flow, vibration, tilt, pressure, reflective, magnetic, temperature, voltage, current, frequency, and percussion transducer/sensors of all sorts and kinds. Such electronic control activations would include utilizing the following signal types as cues: Sound—audible, ultrasonic, and subsonic created by mechanical speaker/microphone, relay buzzer, solid-state, piezoelectric, ceramic, ferrite, magnetic, condenser, and percussion (utilizing all frequencies, pulse rates, duty cycles, pulse widths, amplitudes, duration, repetition rates and such.) Light—all spectrum colors, brilliances, and such (utilizing all frequencies, pulse rates, duty cycles, pulse widths, amplitudes, duration, repetition rates and such.) Taste—sweet to poison. Smell—pungent to flowery. Electrical impulse—Transformer control of low current (50 micro-amps to 100 milliamps) with high-voltage (50 VAC to 10,000 VAC) (utilizing all frequencies, pulse rates, duty cycles, pulse widths, amplitudes, duration, repetition rates and such.) Vibration—motor-drive, mechanical offset fulcrum, pancake, ceramic, percussion and transducer (utilizing all frequencies, pulse rates, duty cycles, pulse widths, amplitudes, duration, repetition rates and such.) Looking more specifically to the figures, FIGS. 2 and 4 depict a hand-held remote controller 100 . If any one of first to fifth function buttons (switches) of the remote controller is pressed, corresponding data and ID codes set by an ID code setting means are provided to an oscillator/modulator 151 . Then, RF signals generated in the oscillator/modulator 151 are amplified at an RF amplifier 152 and an RF output terminal 153 , filtered at a low-pass filter 154 to remove harmonics, and then emitted through an antenna 155 as radio waves. A stimulation adjustment control 130 uses a potentiometer as a “volume” (magnitude) control which allows precise control or gradual change of the stimulation level suitably for an animal, differently from the prior art. A conventional stimulation adjustment means uses a mechanical selector switch, and such a selector switch cannot subdivide a stimulation level precisely. FIGS. 3 and 5 depict a training device 200 . The training device 200 receives the RF signals emitted in the transmission of the remote controller 100 of FIGS. 2 and 4 respectively through an antenna 221 included therein. Then, a high-frequency amplifier 222 amplifies weak radio waves, and a mixer 224 makes a secondary intermediate frequency such that a detector 227 extracts the data sent from the transmitter via a filter 226 . The extracted data is input to a low-frequency amplifier included in a microprocessor 210 . The microprocessor 210 outputs a signal to a selected one of a electrical impulse stimulation generator if the ID code contained in itself is identical to the ID code sent from the transmitter. REFERENCE SYMBOLS FIGS. 2 and 4 Remote Controller 100 120 : Buttons (or, switches) 121 : Brief Stimulation Button Brief low-frequency electrical impulse stimulation (3 to 5 pulses) is generated at the training device regardless of the time during which the button of the remote controller is pressed. 122 : Continuous Stimulation Button Continuous low-frequency electrical impulse stimulation is generated at the training device during the time that the button of the remote controller is pressed (12 seconds at the maximum). 123 : +20 Level Boost Continuous Stimulation Button Boost low-frequency electrical impulse stimulation is preset at 20 levels higher than the continuous impulse level and is generated at the training device during the time that the button of the remote controller is pressed (5 to 7 seconds at the maximum). 124 : Buzzer Button A brief buzz sound is generated at the training device (3 to 5 pulses) regardless of the time during which the button of the remote controller is pressed. 125 : Light Button An LED light at the training device is turned on at the first press and turned off at the second press regardless of the time between when the button of the remote controller is pressed. 130 : Volume Control The volume control is used for adjusting the stimulation level of the training device. A low-frequency electrical impulse stimulation corresponding to the level set by the volume control is generated at the training device by means of the first, second and third function buttons. 132 : V/F Converter An analog voltage according to the level output from the volume control 130 is converted into frequency, which is a digital value recognizable by a microprocessor in the remote controller, and then transmitted to the microprocessor in the training device. For example, 20 Hz signal is provided to the microprocessor in case a volume output voltage is 0.1V (i.e. level 1 ), and 100 Hz signal is provided to the microprocessor in case a volume output voltage is 0.5V (i.e. level 5 ). 110 : Microprocessor The microprocessor controls all functions input from the function buttons 120 and outputs an ID code signal. The microprocessor also has a power ON/OFF function. The microprocessor recognizes and processes the frequency signal supplied according to a stimulation level operates a display 140 and operates a RF control 156 , which controls an RF oscillator 151 and an RF amplifier 152 when a function is operated. In the two-way system (in the second embodiment), the microprocessor processes the data received from the training device 200 . For instance, the microprocessor computes a distance between a user and an animal based on position data of the user and the animal. 140 , 142 : Display The level set by the volume control 130 , and a residual battery capacity of the remote controller is displayed. In the two-way system (in the second embodiment), a residual battery capacity of the training device, a direction and distance of an animal from the user, a moving speed of the animal, and so on are displayed on the display 142 . 151 : Oscillator//Modulator The remote controller uses FM (Frequency Modulation), and a modulation-allowable VOXO is applied to give RF oscillation and modulation at the same time. 152 : RF Amplifier RF output from the oscillator and modulator 151 is low, so the RF amplifier amplifies the output RF such that a following output terminal can be operated. 153 : RF Output The RF output is for amplifying RF such that the remote controller and the training device are within a reachable distance. 154 : Low-pass Filter The low-pass filter blocks high frequencies in the RF signal other than fundamental waves. 155 : Antenna The antenna transmits RF composed of fundamental waves, which has passed through the low-pass filter 154 . In the two-way system (in the second embodiment), the antenna receives RF signal transmitted from the training device. 156 : RF Control When any one of the first to fifth button 121 ˜ 125 of the remote controller is pressed, the RF control supplies power to the oscillator/modulator 151 and the RF amplifier 152 such that the oscillator/modulator 151 and the RF amplifier 152 are operated. 161 : Regulator & Power Switch The regulator & power switch has a constant-voltage IC function that is operated in association with the microprocessor 110 . If the power switch of the remote controller is pressed over 0.5 second, the power is turned on. If the power switch is pressed for over 1 second again after the power is turned on, the power is turned off. 162 : Battery A rechargeable battery, is adopted. 163 : Charging Device The battery 162 is a rechargeable battery and thus the charging device is used. 170 : GPS Module (in the second embodiment) The GPS module 170 receives signals from the GPS of the training device 200 to provide the microprocessor 110 with position data of the trainer. 180 : Two-way Receiver (in the second embodiment) The two-way receiver 180 is used for receiving the information of the training device, and the two-way receiver 180 gives data to the microprocessor 110 . REFERENCE SYMBOLS FIGS. 3 and 5 Training Device 200 221 : Antenna The antenna receives RF signal transmitted from the remote controller 100 . In the two-way system (in the second embodiment), the antenna transmits RF signal to the remote controller 100 . It is preferable that the antenna 221 is an internal (built-in) antenna and a detachable external antenna 221 ′ (see FIG. 1 ) is further provided to extend a reachable distance. 222 : High-frequency Amplifier The high-frequency amplifier amplifies weak RF signals induced to the receiving antenna 221 . 223 : OSC OSC is an oscillator that oscillates in itself to give a secondary intermediate frequency. 224 : Mixer RF signal supplied from the high-frequency amplifier 222 is mixed with the signal supplied from the OSC 223 to make an intermediate frequency that is a secondary frequency. 225 : Intermediate-frequency Amplifier The intermediate-frequency amplifier amplifies the intermediate frequencies made at the mixer 224 . 226 : Filter The filter filters the intermediate frequencies made at the mixer 224 to remove noise. 227 : Detector The detector detects function signals and ID signals sent from the remote controller. 210 : Microprocessor A low-frequency amplifier included in the microprocessor amplifies analog signals detected by the detector 227 ; and, in case the received signal is identical to ID code already stored, a signal of any one selected from the first to fifth button 121 ˜ 125 of the remote controller is output. In the two-way system (in the second embodiment), the microprocessor processes the information of the training device and gives the information to a two-way transmitter 280 . 231 : D/A Converter The D/A converter is used for outputting a stimulation level, set by the volume control of the remote controller, as analog signals. 232 : Electrical Impulse Stimulation Generator The electrical impulse stimulation generator generates high-voltage stimulations to give low-frequency electrical impulse stimulations to an animal utilizing a transformer output. 233 : Stimulation Terminals The stimulation terminals are electrodes for supplying electrical impulse stimulation to an animal. 234 : Stimulation Generating Circuit Control When the first, second and third function button 121 ˜ 123 of the remote controller are pressed, the stimulation generating circuit control 234 supplies power to the electrical impulse stimulation generator 232 to operate the electrical impulse stimulation generator 232 . 241 : Buzzer Driver The buzzer driver is used for operating a magnetic buzzer when the fourth function button 124 of the remote controller is pressed. 242 : Magnetic Buzzer The magnetic buzzer 242 is used for converting electric signals into sound signals. 251 : Light Driver The light driver 251 is used for operating at least one LED light when the fifth function button 125 of the remote controller is pressed. 252 : LED Two high-brightness LED's 252 are applied to convert electric signals into light signals. 261 : Regulator & Power Switch The regulator & power switch 261 has a constant-voltage IC function that is operated in association with the microprocessor 210 . If the magnet is contacted with the lead switch of the training device over 0.5 second, the power is turned on. If the magnet is contacted over 0.5 second again after the power is turned on, the power is turned off. 262 : Battery A rechargeable battery, is adopted. 263 : Charging Means The battery 262 is a rechargeable battery and thus the charging means 263 is used. 270 : GPS (in the second embodiment) The GPS (Global Positioning System) 270 obtains reference signals from at least three satellites to provide the microprocessor 210 with position data of the animal. 280 : Two-way Transmitter (in the second embodiment) The two-way transmitter 280 is used for transmitting the information of the training device, and the two-way transmitting 280 emits data as radio waves. Thus, an improved animal training device has been disclosed. While embodiments and applications of this invention have been shown and described, it would be apparent to those skilled in the art that many more modifications are possible without departing from the inventive concepts herein. The invention, therefore is not to be restricted except in the spirit of the appended claims.

1a

FIELD OF THE INVENTION [0001] The present invention relates to a medical manipulator by which an end effector can be inserted into the interior of a living body for enabling a treatment to be carried out on a treatment target. BACKGROUND OF THE INVENTION [0002] In a surgical treatment, without performing a thoracotomy or a laparotomy with respect to a patient, small holes are opened in the body, forceps, scissors, or the like are introduced into the body through the holes, and a desired surgical treatment (a so-called endoscopic surgical procedure) is carried out on diseased biological tissue or the like in the body. Recently, in this type of treatment, in addition to forceps or scissors, a medical manipulator is used, which is capable of performing operations with a higher degree of freedom in the living body. [0003] For example, with the medical manipulator disclosed in Japanese Laid-Open Patent Publication No. 2011-072570, during the surgical treatment, an end effector, which is disposed on a distal end side of a shaft, is inserted into the living body. The end effector is constituted as a gripper that is capable of gripping a target object to be treated and then applying electrical energy to the target object to be treated. By transmitting an operating force from an operating element (main body portion) disposed on the proximal end side of the shaft, variations in posture (for example, a yawing operation to tilt the gripper in a direction differing from the axial direction of the shaft, a rolling operation to rotate the gripper about the axis of the shaft, etc.) or opening and closing operations of the gripper are carried out. [0004] In the case that a surgical treatment is carried out using the medical manipulator, a plurality of holes are opened in the abdomen or the like of a patient, and an endoscope (camera) and a forceps or the like are inserted into the body cavity, together with inserting a distal end (gripper) of the medical manipulator. Consequently, under observation of the camera, the gripper is delivered to the site of a living tissue (treatment object) in the body, and by a closing operation of the gripper, the living tissue is gripped while electrical current is applied to the living tissue. During delivery of the gripper or when a treatment on the living tissue is performed, based on the operating force transmitted from the main body portion, the state of the gripper (the posture or the opening/closing condition thereof) can freely be changed at locations in the living body. SUMMARY OF THE INVENTION [0005] The present invention has been devised in relation to the above-described medical manipulator, and has the object of providing a medical manipulator, which enhances the operability of an end effector that carries out a treatment on a treatment target, whereby the treatment can be implemented efficiently and with improved accuracy. [0006] To accomplish the aforementioned objects, the present invention is characterized by a medical manipulator including a shaft, a distal end working unit provided on a distal end of the shaft and having an end effector configured to carry out a treatment on a treatment target, and a main body portion disposed on a proximal end of the shaft and configured to operate the end effector based on an input from a person. The distal end working unit includes a bending portion disposed between the end effector and the shaft and which causes the distal end working unit to bend in a direction that differs from an axial direction of the shaft, in accordance with an operating force in the bending direction that is transmitted from the main body portion, and a tube, which is disposed at a position overlapping with the bending portion and is capable of bending in following relation to the movement of the bending portion. The tube transmits a rotational operating force, which is transmitted from the main body portion, to the end effector, so as to enable the end effector to be rotated through an unlimited range of rotation. [0007] According to the above description, the tube that is disposed in a position overlapping with the bending portion bends in following relation with the movement of the bending portion. Therefore, for example, even in the case that the treatment target is located deeply inside the living body, the posture of the end effector can easily be changed, and the end effector can be delivered smoothly to the treatment target. Further, the tube delivers the operating force in the rotational direction to the end effector, and the end effector is capable of rotating through an unlimited range of rotation, whereby the posture of the end effector at the distal end side of the bending portion can freely be changed, and a precise treatment can be carried out by changing the orientation of the end effector any number of times to conform with the treatment target. More specifically, high operability for the end effector is obtained, and the procedure performed on the treatment target can be conducted efficiently and accurately. [0008] The bending portion may include a structure in which three or more rigid joint members are arrayed in the axial direction, and the adjacent joint members are connected to each other so as to bend mutually. Further, the tube may extend over a length that is longer than the axial length of the bending portion. [0009] In this manner, with a structure in which three or more joints are subjected to bending, the bending portion can be bent gently and gradually. Further, the tube, which extends a greater length than the bending portion, easily bends in following relation to the bending portion, so that even in a bent state, the operating force in the direction of rotation can be transferred smoothly to the end effector. [0010] The distal end working unit may transmit operating forces in a distal end direction and a proximal end direction, which are transferred from the main body portion, to the end effector through the tube. [0011] In this manner, by transferring operating forces in the distal end and proximal end directions, to the end effector through the tube, the end effector can be caused to carry out various operations by the operating forces in the distal end and proximal end directions. [0012] In this case, the end effector is a gripper in which first and second gripper members are opened and closed to grip the treatment target. The gripper can close the first and second gripper members by the operating force in the proximal end direction that is transmitted through the tube, and can open the first and second gripper members by the operating force in the distal end direction that is transmitted through the tube. [0013] In this manner, assuming a structure is provided in which the first and second gripper members are opened and closed by operating forces in the distal end and proximal end directions, the treatment target can easily be sandwiched and gripped between the gripper members, and a predetermined treatment can be performed efficiently. [0014] Furthermore, the distal end working unit may include an outer shell member connected to a distal end of the bending portion, and a retaining member, which retains the end effector under a condition in which at least a portion of the retaining member is accommodated in the interior of the outer shell member, and is rotated relatively with respect to the outer shell member by the rotational operating force from the tube. [0015] Consequently, since the tube and the retaining member can be rotated relatively with respect to the bending portion and the outer shell member, the end effector that is held on the retaining member can be rotated suitably. [0016] In this case, the outer shell member may include a groove that is engraved in a circumferential direction on an inner wall confronting an outer surface of the retaining member, and the retaining member may include a projection that is inserted rotatably in the groove. [0017] In this manner, by inserting the projection of the retaining member rotatably in the groove, rotation of the retaining member is guided by the groove, and therefore, the retaining member (i.e., the end effector) can be rotated more reliably. [0018] Further, plural coils may be disposed in the interior of the tube in an overlapping manner so as to surround a hollow portion that extends in the axial direction, and at least two coils among the plural coils may be wound in mutually different winding directions. [0019] In this manner, by arranging the two coils, which are wound in different winding directions, in the interior of the tube, the strength of the tube can be increased. As a result, the rotational operating forces from the shaft can be transferred smoothly to the end effector through the tube. [0020] According to the present invention, the operability of an end effector that carries out a treatment on a treatment target can be improved, whereby the treatment can be implemented efficiently and with improved accuracy. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 is a perspective view showing the overall structure of a medical manipulator according to an embodiment of the present invention; [0022] FIG. 2 is a perspective view showing an enlarged representation of main components of a distal end working unit of the manipulator of FIG. 1 ; [0023] FIG. 3A is a first schematic view for describing in outline an energizing operation of the manipulator of FIG. 1 ; [0024] FIG. 3B is a second schematic view for describing in outline the energizing operation of the manipulator of FIG. 1 ; [0025] FIG. 4A is a first schematic view for describing in outline a yawing operation of the manipulator of FIG. 1 ; [0026] FIG. 4B is a second schematic view for describing in outline the yawing operation of the manipulator of FIG. 1 ; [0027] FIG. 5 is a schematic view for describing in outline a rolling operation of the manipulator of FIG. 1 ; [0028] FIG. 6A is a first schematic view for describing in outline an opening and closing operation of the manipulator of FIG. 1 ; [0029] FIG. 6B is a second schematic view for describing in outline the opening and closing operation of the manipulator of FIG. 1 ; [0030] FIG. 7 is a partial exploded perspective view showing an enlarged representation of a distal end side of the manipulator of FIG. 1 ; [0031] FIG. 8 is a partial exploded perspective view showing an enlarged representation of a bending portion of the manipulator of FIG. 1 ; [0032] FIG. 9 is a partial exploded perspective view showing an enlarged representation of a handle of the manipulator of FIG. 1 ; [0033] FIG. 10 is a schematic plan view for describing the yawing operation of the manipulator of FIG. 1 ; [0034] FIG. 11 is a partial perspective view for describing the yawing operation of the manipulator of FIG. 1 ; [0035] FIG. 12 is a partial perspective view for describing an assembled condition in the interior of the handle of FIG. 1 ; [0036] FIG. 13A is a side view showing main components of the bending portion of the manipulator of FIG. 1 ; [0037] FIG. 13B is a plan view showing main components of the bending portion of the manipulator; [0038] FIG. 13C is a cross sectional view taken along line XIIIC-XIIIC of FIG. 13B ; [0039] FIG. 14A is a partial perspective view showing at an enlarged scale a joint member of FIG. 13A ; [0040] FIG. 14B is a partial perspective view showing at an enlarged scale an assembled condition of the joint members; [0041] FIG. 15 is a schematic side view for describing the rolling operation of the manipulator of FIG. 1 ; [0042] FIG. 16 is a partial perspective view for describing an assembled condition in the interior of the handle of FIG. 1 ; [0043] FIG. 17 is a perspective view, partially cut away, of main components of a distal end part of the manipulator of FIG. 1 ; [0044] FIG. 18A is a cross sectional plan view showing a distal end part of the manipulator of FIG. 1 ; [0045] FIG. 18B is a cross sectional side view showing a distal end part of the manipulator of FIG. 1 ; [0046] FIG. 19 is a schematic perspective view for describing an opening and closing operation of the gripper of FIG. 1 ; [0047] FIG. 20A is a first side view for describing operations on the side of the handle of FIG. 19 ; [0048] FIG. 20B is a second side view for describing operations on the side of the handle of FIG. 19 ; [0049] FIG. 21A is a principal plan view showing the gripper of FIG. 1 ; [0050] FIG. 21B is a partial plan view showing an open state of the gripper; and [0051] FIG. 21C is a partial plan view showing a closed state of the gripper. DETAILED DESCRIPTION OF THE INVENTION [0052] Hereinafter, a preferred embodiment of a medical manipulator according to the present invention will be described in detail below with reference to the accompanying drawings. [0053] FIG. 1 is a perspective view showing the overall structure of the medical manipulator according to the present embodiment. The medical manipulator (hereinafter referred to simply as a “manipulator 10 ”) according to the present embodiment is used in an endoscopic surgical procedure, and is configured to carry out a predetermined process (e.g., cauterization by application of heat) by applying electrical energy to a living tissue that serves as a treatment target X. As a biological tissue that serves as the treatment target X on which the manipulator 10 performs a treatment, for example, tumors (lesions), muscles, blood vessels, or nerves, etc., may be cited. [0054] The end effector of the manipulator 10 is constituted as a gripper 12 (electrosurgical knife) that applies electrical energy to the treatment target X by gripping the treatment target X. In the interior of the manipulator 10 , various mechanisms are provided for implementing delivery and gripping (an energizing operation) of the gripper 12 . Below, a detailed description will be given concerning the manipulator 10 . [0055] As shown in FIG. 1 , the manipulator 10 comprises a distal end working unit 14 having a gripper 12 for carrying out a surgical procedure end, and a handle 18 (main body portion) disposed on the proximal end side of the shaft 16 , and which operates the distal end working unit 14 based on an operation (input) from a person or user of the manipulator 10 . Further, a controller 20 is connected to the handle 18 of the manipulator 10 for supplying desired electrical power when the distal end working unit 14 is operated. In addition, a high frequency power source 22 for energizing (supplying high frequency voltage) to the gripper 12 is connected to the handle 18 . [0056] Upon use of the manipulator 10 , the handle 18 is gripped and operated by the user (an operator such as a doctor or the like), and a distal end side of the manipulator 10 (the distal end working unit 14 and the distal end side of the shaft 16 ) is inserted into the body of a patient. At this time, the user opens a small diameter hole at a predetermined position on the body surface of the patient, installs a trocar 24 together with injecting a carbon dioxide gas, and inserts the shaft 16 into the patient via the trocar 24 . Further, in a state in which the distal end side of the manipulator 10 is inserted into the body, while observations are made through an endoscope, variations in posture and opening and closing operations of the gripper 12 are carried out appropriately. Consequently, the gripper 12 is delivered to the site of the treatment target X, and a procedure is performed to supply electrical current to the treatment target X. [0057] The structure of the end effector is not limited to a gripper 12 that supplies current to the treatment target X, and various alternative structures may be adopted for the end effector. For example, as the end effector, there may be applied a scissors or a surgical knife (blade) for cutting living tissue. Further, the end effector may be constituted as a gripping device for gripping a medical device (forceps, needle, etc.), and a surgical procedure can be performed on the treatment target X by the medical device that is gripped. [0058] As shown in FIG. 2 , variations in posture and opening and closing operations of the gripper 12 are implemented on a distal end working unit 14 on the distal end of the manipulator 10 . As changes in the posture of the gripper 12 , there may be cited a yawing operation by which the gripper 12 is tilted so as to curve in a lateral direction (yawing direction) with respect to an axis Os of the shaft 16 , and a rolling operation in which the gripper 12 is rotated about an axis Or of the gripper 12 . Naturally, the variations in posture of the gripper 12 are not limited to a yawing operation and a rolling operation. For example, a pitch operation may be performed in which the gripper 12 is tilted in a vertical direction (pitch direction) with respect to the axis Os of the shaft 16 . [0059] The gripper 12 is constituted from two gripper members (first gripper member 26 , second gripper member 28 ), which are held while being capable of opening and closing by a gripper retaining member 30 . Distal end parts of the first and second gripper members 26 , 28 are subjected to an opening and closing operation about a vertically oriented axis Og of the gripper retaining member 30 . The proximal end side of the gripper retaining member 30 is inserted rotatably through a cylindrically shaped outer shell member 32 . A bending portion 34 (joint part) that carries out the yawing operation of the distal end working unit 14 is connected to the proximal end side of the outer shell member 32 . [0060] The bending portion 34 is constituted by juxtaposing in the axial direction a plurality of joint members 36 (five are shown in FIG. 2 ), which are made of a hard material, for example, stainless steel (hereinbelow, a description will be given in which the letters A through E are appended to each of the respective joint members 36 in order from the distal end side). The adjacent joint members 36 are connected so as to be mutually rotatable about hinge members 38 . Further, concerning the joint members 36 , the joint member 36 A on the furthest most distal end side is connected in a bendable fashion to the outer shell member 32 , whereas the joint member 36 E on the furthest most proximal end side is connected and fixed to the distal end of the shaft 16 . In the present embodiment, although stainless steel is used as the material for the joint members 36 , the invention is not limited to this feature, insofar as the joint members 36 are excellent in durability and are capable of realizing the functions of the present invention. For example, a polyether ether ketone resin (PEEK) may be used. [0061] The yawing operation of the distal end working unit 14 is implemented by continuing to bend in a linked manner the five hinge members 38 about the operational fulcrum of the joint member 36 E. Stated otherwise, by the outer shell member 32 and the joint members 36 A through 36 D being inclined in a yawing direction at substantially the same angle, the gripper 12 and the gripper retaining member 30 on the distal end side of the bending portion 34 are tilted integrally. The movable range of the yawing operation of the bending portion 34 can be set appropriately. For example, if the movable range is set up to a range at which the roll axis Or of the gripper 12 becomes perpendicular to the axis Os of the shaft 16 , i.e., a range in which the gripper 12 can be tilted to the left and right, that is, tilted 180°, the facing orientation of the gripper 12 can be varied over a wide range within the body. [0062] On the other hand, the rolling operation of the distal end working unit 14 is carried out by rotating the gripper retaining member 30 relatively to the outer shell member 32 . Stated otherwise, the outer shell member 32 that is connected to the bending portion 34 is maintained in a fixed condition with respect to the direction of rotation, and the gripper retaining member 30 rotates with respect to the outer shell member 32 . Therefore, the gripper 12 and the gripper retaining member 30 rotate together in unison. Further, in the present embodiment, the movable range (range of rotation of the gripper 12 ) of the rolling operation is unlimited. [0063] Furthermore, the opening and closing operation of the gripper 12 is carried out by opening and closing the first and second gripper members 26 , 28 , i.e., by having the distal end parts of the first and second gripper members 26 , 28 approach toward (abut) and separate away from each other, in a state of being held by the gripper retaining member 30 . The opening and closing operation of the gripper 12 can be realized at a desired timing based on operations of the user, regardless of any change in the posture of the gripper 12 . [0064] In the present embodiment, the variation in posture (the yawing operation and the rolling operation) of the gripper 12 and the opening and closing operation of the gripper 12 are carried out based on operating forces that are transmitted from the shaft 16 to the distal end working unit 14 . [0065] Returning to FIG. 1 , the shaft 16 that is connected to the distal end working unit 14 extends in a straight line over a predetermined length (e.g., 350 mm), and the handle 18 is connected to a proximal end portion of the shaft 16 . The shaft 16 includes a function to transfer operating forces from the handle 18 to the distal end working unit 14 . Further, during a surgical procedure, the proximal end side of the shaft 16 is exposed outside the body of the patient, and by manipulating the position and angle of the manipulator 10 (shaft 16 ) from the outside, the insertion angle and insertion amount of the distal end working unit 14 that is inserted in the body are changed. [0066] The handle 18 includes a handle main body 40 that is formed in the shape of a pistol for enabling easy gripping thereof by one hand of the user, and a drive unit 41 that is capable of being attached to and detached from an upper proximal end side portion of the handle main body 40 . The handle main body 40 includes a body portion 42 , which extends in the same direction as the axial direction of the shaft 16 , and a gripping unit 44 that extends downwardly from a lower side of the body portion 42 . [0067] The body portion 42 includes an internal space (not shown) having a comparatively large volume, and is provided with various mechanisms in the internal space for effecting operations (the yawing operation, the rolling operation, the opening and closing operation of the gripper 12 ) of the above-described distal end working unit 14 . On the other hand, a drive motor 46 (see FIG. 11 ) that serves as a drive source for the yawing operation of the distal end working unit 14 is accommodated in the interior of the drive unit 41 . Further, the aforementioned controller 20 and the high frequency power source 22 are connected to the drive unit 41 . The controller 20 is connected to a non-illustrated power source, and includes a function to control rotary driving of the drive motor 46 . The high frequency power source 22 includes a function to supply power (high frequency voltage) to the gripper 12 based on manipulations performed by the user. [0068] Switches 48 (tilting operation unit) that carry out the yawing operation of the distal end working unit 14 are connected to side surfaces of the body portion 42 . Further, a rotating handle 50 (rolling operation unit) that carries out the rolling operation of the distal end working unit 14 is disposed in surrounding relation to an outer side of the shaft 16 at a portion where the shaft 16 is connected to the distal end side of the body portion 42 . Furthermore, a trigger 52 (opening and closing operation unit) that carries out the opening and closing operation of the gripper 12 is disposed in front of the gripping unit 44 on a lower side of the body portion 42 . [0069] The gripping unit 44 is formed somewhat more toward the distal end side than a middle region in the axial direction of the body portion 42 , and has a structure such that, in a condition in which a user grips the gripping unit 44 with one hand, the switches 48 , the rotating handle 50 , and the trigger 52 can be operated by a finger of the one hand that has gripped the gripping unit 44 . [0070] Operations of the distal end working unit 14 are carried out by the switches 48 , the rotating handle 50 and the trigger 52 being manipulated suitably by the user. The manipulator 10 according to the present embodiment performs a treatment on the treatment target X by mutually linking changes in posture (the yawing operation, the rolling operation) and the opening and closing operation of the gripper 12 , and an energizing operation based on the opening and closing operation of the gripper 12 . In the following description, to facilitate understanding of the invention, structures related to such operations will be described separately below in outline. [0071] FIG. 3A is a first schematic view for describing in outline the energizing operation of the manipulator 10 of FIG. 1 , and FIG. 3B is a second schematic view for describing in outline the energizing operation of the manipulator 10 of FIG. 1 . First, a structure for enabling the energizing operation of the manipulator 10 will be described in outline. [0072] As described above, the manipulator 10 includes a function to supply electrical current to the treatment target X while the treatment target X is gripped by the gripper 12 . Therefore, the first and second gripper members 26 , 28 are made from a metal material, and constitute electrodes (a minus electrode and a plus electrode) that supply current to the treatment target X. More specifically, the gripper 12 according to the present embodiment is a bipolar type of electrosurgical knife. Naturally, the invention is not limited to such a structure, and the end effector may be constituted as a monopolar type of electrosurgical knife. [0073] The first gripper member 26 and the second gripper member 28 are pivotally supported in an insulated state by a single fulcrum pin 54 (see FIG. 2 ). When the operating force of the opening and closing operation is received, the distal end parts of the first and second gripper members 26 , 28 are made to approach and separate away from one another about the fulcrum pin 54 . Therefore, although supply of current is interrupted in an open state in which the distal end parts of the first and second gripper members 26 , 28 are separated, in a closed state in which the distal end parts of the first and second gripper members 26 , 28 are brought into abutment (including a condition of an indirectly closed state upon sandwiching the treatment target X), the first and second gripper members 26 , 28 become energized to thereby supply electrical current to the treatment target X. [0074] Respective metal members 56 (conductive paths) are connected electrically to the proximal end sides of the first and second gripper members 26 , 28 . The metal members 56 (e.g., copper wires) of two polarities are covered by insulating members 58 at portions thereof that extend along the bending portion 34 and the shaft 16 , and the two insulating members 58 extend in the form of a single combined conductive line 60 as a result of being joined by welding or an adhesive. The conductive line 60 extends toward the proximal end together with the shaft 16 , and is inserted into the handle 18 . In the present embodiment, the conductive line 60 is arranged to pass through the axial center (axis Os) of the bending portion 34 and the shaft 16 . Consequently, since there is no need to provide separate wiring for the conductive line on the side surface of the distal end working unit 14 or the shaft 16 , entanglement of the conductive line by operating the distal end working unit 14 is avoided, and supply of current can suitably be performed. [0075] The conductive line 60 extends to the proximal end side of the shaft 16 that is inserted into the interior of the handle 18 , and the two metal members 56 in the conductive line 60 are connected respectively to a pair of cylindrical terminals 62 (rotating terminals) that are disposed on the shaft 16 . Contact terminals 64 are in contact respectively with the pair of cylindrical terminals 62 , and the contact terminals 64 are connected to the high frequency power source 22 externally of the handle 18 . [0076] FIG. 4A is a first schematic view for describing in outline the yawing operation of the manipulator 10 of FIG. 1 , and FIG. 4B is a second schematic view for describing in outline the yawing operation of the manipulator 10 of FIG. 1 . Next, a structure for implementing the yawing operation will be described in outline. [0077] As described above, the yawing operation of the manipulator 10 is realized by the bending portion 34 that is connected to the distal end working unit 14 . On inner side surfaces in the width direction of the five joint members 36 that are arrayed in the axial direction, a pair of belts (a first belt 66 and a second belt 68 ) are inserted. The respective joint members 36 hold the first and second belts 66 , 68 slidably. The distal end sides of the first and second belts 66 , 68 are connected to the outer shell member 32 , and the proximal end sides thereof are connected to a pair of semicircular pipes (first semicircular pipe 70 , second semicircular pipe 72 : bending operation force transmitting members) that extend inside the shaft 16 . [0078] The first and second semicircular pipes 70 , 72 are inserted through the interior of the shaft 16 extending to the handle 18 , and are connected to a pair of slide members (first slide member 74 , second slide member 76 ), which are disposed in the interior of the handle 18 . The first and second slide members 74 , 76 are arranged at mutually confronting positions, with racks 78 being formed respectively on confronting surfaces thereof. Further, between the first and second slide members 74 , 76 , a single pinion 80 (rotating member) is arranged in meshing relation with both of the racks 78 . The pinion 80 is connected mechanically to the drive motor 46 through a plurality of gears, which will be described later. [0079] With the manipulator 10 , which is constructed in this manner, for example, as shown in FIG. 4B , when the pinion 80 is rotated clockwise by rotary driving of the drive motor 46 , the first slide member 74 undergoes sliding movement in the proximal end direction, and the second slide member 76 undergoes sliding movement in the distal end direction. Therefore, the first semicircular pipe 70 , which is connected to the first slide member 74 , also undergoes sliding movement in the proximal end direction, and the second semicircular pipe 72 , which is connected to the second slide member 76 , also undergoes sliding movement in the distal end direction. The operating forces of the first and second semicircular pipes 70 , 72 are transmitted to the distal end working unit 14 (bending portion 34 ). [0080] More specifically, by the first belt 66 being moved relatively to the bending portion 34 in the proximal end direction, the first belt 66 in the bending portion 34 becomes shorter, and by the second belt 68 being moved relatively to the bending portion 34 in the distal end direction, the second belt 68 in the bending portion 34 becomes longer. As a result, the five joint members 36 tilt in conjunction to the side of the shortened first belt 66 , the outer shell member 32 that is connected to the distal end side of the joint members 36 is tilted, and the gripper 12 and the gripper retaining member 30 are made to move laterally (in the yawing direction) with respect to the axis Os of the shaft 16 . [0081] FIG. 5 is a schematic view for describing in outline the rolling operation of the manipulator 10 of FIG. 1 . Next, a structure for implementing the rolling operation will be described in outline. [0082] As described above, the rolling operation of the manipulator 10 is carried out by rotating the gripper 12 and the gripper retaining member 30 relatively with respect to the outer shell member 32 . A rotatable hollow tube 82 is connected to the proximal end side of the gripper retaining member 30 , and the hollow tube 82 is inserted through the interior of the bending portion 34 (the five joint members 36 ). The hollow tube 82 is flexible and is capable of following the bending movement of the bending portion 34 , and is constructed as a torque tube, which is capable of rotating even if the hollow tube 82 is bent in following relation to the bending portion 34 . The conductive line 60 (see FIG. 3A ) is inserted through the interior of the hollow tube 82 . The outer diameter of the hollow tube 82 preferably is 2.5 mm to 3.0 mm, and in the present embodiment, a description is given in which the outer diameter thereof is 2.7 mm. [0083] The shaft 16 that is connected to the bending portion 34 is constituted by a double tube structure, including an outer tube 84 that makes up the exterior and extends in the axial direction, and an inner tube 86 that is inserted through the interior of the outer tube 84 . The hollow tube 82 is connected to the inner tube 86 of the shaft 16 , and rotates by receiving an operating force (rotational torque) in the direction of rotation that is transmitted from the inner tube 86 . [0084] The proximal end side of the outer tube 84 is inserted into the handle 18 , and is connected fixedly at a distal end position of the handle 18 . On the other hand, the inner tube 86 extends toward the proximal end more so than the outer tube 84 , and is supported rotatably by a rotation mechanism 88 in the interior of the handle 18 . The rotation mechanism 88 includes a plurality of gears, and the inner tube 86 is connected mechanically through the plural gears to the rotating handle 50 that is disposed on the distal end side of the handle 18 . The rotating handle 50 is rotatable along the circumferential direction of the outer tube 84 . [0085] Accordingly, when the user manually performs a rotating operation on the rotating handle 50 , the rotational torque of the rotating handle 50 is transmitted to the interior of the handle 18 on the proximal end side, and the inner tube 86 is made to rotate through the rotation mechanism 88 . The operating force in the direction of rotation of the inner tube 86 is transmitted to the hollow tube 82 , and the hollow tube 82 rotates together with the inner tube 86 . As a result, the gripper retaining member 30 (gripper 12 ), which is connected to the distal end side of the hollow tube 82 , is rotated about the axis Or of the gripper 12 . In particular, in the manipulator 10 according to the present embodiment, the gripper 12 , the gripper retaining member 30 , the hollow tube 82 , and the inner tube 86 are arranged in a separated state with respect to the outer shell member 32 , the bending portion 34 , and the outer tube 84 , and are capable of being rotated through an unlimited range of rotation. Accordingly, a change in posture of the gripper 12 by the rolling operation can be carried out any number of times. [0086] FIG. 6A is a first schematic view for describing in outline the opening and closing operation of the manipulator 10 of FIG. 1 , and FIG. 6B is a second schematic view for describing in outline an opening and closing operation of the manipulator 10 of FIG. 1 . Next, a structure for implementing the opening and closing operation will be described in outline. [0087] The opening and closing operation of the gripper 12 is realized by transmission of the operating force in the distal end and proximal end directions from the handle 18 with respect to the gripper 12 . The first and second gripper members 26 , 28 comprise extension pieces 90 that extend backward obliquely toward the proximal end side beyond the fulcrum pin 54 about which the first and second gripper members 26 , 28 pivot mutually. Long holes 92 are formed in the extension pieces 90 . A moving body 94 , which is capable of advancing and retracting (i.e., moving in the distal end and proximal end directions) relatively with respect to the gripper retaining member 30 , is arranged in the interior of the gripper retaining member 30 . A movable pin 96 , which is attached to the moving body 94 , is inserted into the long holes 92 . The relationship in which the gripper retaining member 30 and the moving body 94 are arranged is a relationship where, during the rolling operation, the gripper retaining member 30 and the moving body 94 move together, however, during the opening and closing operation, the gripper retaining member 30 does not move, and the moving body 94 makes advancing and retracting movements. Therefore, the movable pin 96 (moving body 94 ) approaches toward and separates away from the fulcrum pin 54 of the gripper retaining member 30 . [0088] The above-described hollow tube 82 is connected to the proximal end side of the moving body 94 . The moving body 94 undergoes advancing and retracting movements by transmission of the operating force in the distal end and proximal end directions from the hollow tube 82 . Further, the above-described inner tube 86 is connected to the proximal end side of the hollow tube 82 , and an advancing and retracting movement mechanism 98 in the handle 18 is connected to the proximal end side of the inner tube 86 . The advancing and retracting movement mechanism 98 includes a plurality of links, which mechanically connect the inner tube 86 with the trigger 52 that is disposed on the lower side of the handle 18 . [0089] For example, when the user performs a manual operation to pull the trigger 52 , the operating force of the trigger 52 is transmitted to the proximal end side within the handle 18 , and the inner tube 86 is moved in the direction of the proximal end through the advancing and retracting movement mechanism 98 . The operating force in the proximal end direction of the inner tube 86 is transmitted to the moving body 94 through the hollow tube 82 , whereby the moving body 94 undergoes a retracting movement. Conversely, if a pressing operation of the trigger 52 is performed, the moving body 94 undergoes an advancing movement. [0090] As shown in FIG. 6A , in the position at which the moving body 94 is moved forward (i.e., in a state in which the movable pin 96 is located on the distal end side of the long holes 92 ), the extension pieces 90 of the first and second gripper members 26 , 28 intersect at the location of the movable pin 96 . Therefore, the distal end portions of the first and second gripper members 26 , 28 separate away from one another and are placed in an open condition. As shown in FIG. 6B , at the position at which the moving body 94 is retracted (i.e., in a state in which the movable pin 96 is located on the proximal end side of the long holes 92 ), the long holes 92 of the first and second gripper members 26 , 28 are guided, and the respective extension pieces 90 come into mutual proximity (overlap) with each other. Accordingly, the distal end portions of the first and second gripper members 26 , 28 approach one another mutually and are placed in a closed condition. In this manner, at the gripper 12 , an opening and closing operation is realized by transmission of the operating force in the distal end and proximal end directions from the hollow tube 82 . [0091] FIG. 7 is a partial exploded perspective view showing an enlarged representation of a distal end side of the manipulator 10 of FIG. 1 , FIG. 8 is a partial exploded perspective view showing an enlarged representation of the bending portion 34 of the manipulator 10 of FIG. 1 , and FIG. 9 is a partial exploded perspective view showing an enlarged representation of the handle 18 of the manipulator 10 of FIG. 1 . Next, with reference to FIGS. 7 through 9 , members that make up the manipulator 10 according to the present embodiment will be described in detail. [0092] The first and second gripper members 26 , 28 that constitute the gripper 12 are of a shape that extends in the distal end direction while the distal end portions are curved downward, and serrated meshing teeth 100 are formed on mutually confronting surfaces thereof. The meshing teeth 100 of the first and second gripper members 26 , 28 enmesh with one another in a closed state. Further, the extension pieces 90 of the first and second gripper members 26 , 28 are formed in flat plate shapes having a predetermined plate thickness (e.g., 0.5 mm), which extend from proximal end portions of the meshing teeth 100 . Round holes 102 in which the fulcrum pin 54 is fitted are bored through the extension pieces 90 at portions near the distal ends thereof. The fulcrum pin 54 is supported by insulating rings 104 , which are fitted into the round holes 102 . Long holes 92 are bored through proximal end sides of the extension pieces 90 . A movable pin 96 is inserted through an insulating tube 106 in the long holes 92 . Further, the extension pieces 90 of the first and second gripper members 26 , 28 are inserted respectively into gaps 108 on the distal end side of the gripper retaining member 30 . [0093] The gripper retaining member 30 is made up from a three-pronged retaining member side section 112 that extends toward the distal end such that plate-shaped retaining plates 110 branch in three prongs so as to form the gaps 108 , and an engagement tubular portion 114 , which extends toward the proximal end and joins with the proximal end side of the three-pronged retaining member side section 112 . Fulcrum pin holes 116 through which the fulcrum pin 54 is inserted are formed on distal end parts of the three retaining plates 110 , and movable pin long holes 118 through which the movable pin 96 is inserted are formed on a proximal end side of the fulcrum pin holes 116 . A projection 120 , which projects radially outward and extends in the circumferential direction, is disposed on an outer surface of the engagement tubular portion 114 . Further, within the three-pronged retaining member side section 112 and the engagement tubular portion 114 , a sliding space 122 through which the moving body 94 is inserted (see FIG. 18A ) is formed in a continuous manner. [0094] In a condition in which the first and second gripper members 26 , 28 are arranged in the gaps 108 , the fulcrum pin 54 is inserted through the fulcrum pin holes 116 , and the end of the fulcrum pin 54 is fixed by a washer 124 , whereby the first and second gripper members 26 , 28 are pivotally supported. In a condition in which the first and second gripper members 26 , 28 are fixed by the fulcrum pin 54 , and the moving body 94 has been inserted through the sliding space 122 , the movable pin 96 is inserted through the long holes 92 and the movable pin long holes 118 , and by fixing the end of the movable pin 96 through a washer 126 , the movable pin 96 is arranged so as to be capable of advancing and retracting with respect to the long holes 92 and the movable pin long holes 118 . [0095] Similar to the gripper retaining member 30 , the moving body 94 has a three-pronged moving body side section 132 that extends toward the distal end such that plate-shaped retaining plates 128 branch in three prongs so as to form gaps 130 having the same width as the gaps 108 , and an insertion part 134 , which extends toward the proximal end and joins with the proximal end side of the three-pronged moving body side section 132 . Movable pin round holes 136 are formed on distal end parts of the three retaining plates 128 . The movable pin 96 is inserted through the movable pin round holes 136 , whereby attachment with the moving body 94 is completed. Further, a cylindrical body 138 is inserted in the insertion part 134 of the moving body 94 . A retaining plate 128 a , which extends in the center among the three retaining plates 128 of the moving body 94 , is made of an insulating material. [0096] The cylindrical body 138 extends a predetermined length (e.g., 6 mm) in the axial direction, and a hollow space 140 is formed in the interior of the cylindrical body 138 . The insertion part 134 is inserted in a distal end portion of the cylindrical body 138 , and a first connector 142 is inserted in a proximal end portion of the cylindrical body 138 . [0097] The first connector 142 includes a flange 144 disposed at an intermediate location, a distal end connecting projection 146 that extends toward the distal end from the flange 144 , and a proximal end connecting projection 148 that extends toward the proximal end from the flange 144 . The distal end connecting projection 146 of the first connector 142 is inserted into the cylindrical body 138 , and the proximal end connecting projection 148 of the first connector 142 is inserted into the hollow tube 82 , thereby connecting the cylindrical body 138 and the hollow tube 82 to each other. In a state in which the hollow tube 82 (first connector 142 ) is connected thereto, the cylindrical body 138 is inserted into the interior of the outer shell member 32 . [0098] The outer shell member 32 is made up from a distal end side tubular portion 150 in which the engagement tubular portion 114 of the gripper retaining member 30 is inserted, and a proximal end side tubular portion 152 in which the cylindrical body 138 is inserted. The distal end side tubular portion 150 includes an arcuate piece 150 a that is separable in half from one side. On an inner surface of the distal end side tubular portion 150 (including the arcuate piece 150 a ), a groove 154 having a predetermined width (e.g., 2 mm) is provided. In the inserted condition of the gripper retaining member 30 , the projection 120 thereof is inserted in engagement with the groove 154 . [0099] The cylindrical body 138 , the first connector 142 , and the distal end side of the hollow tube 82 are inserted into the proximal end side tubular portion 152 . At upper and lower positions of the proximal end side tubular portion 152 , outer shell member side hinge pieces 156 are formed, which project in the proximal end direction. The outer shell member side hinge pieces 156 are connected bendably to the bending portion 34 positioned on the proximal end side with respect to the hinge pieces 156 . Further, cutout portions 158 , which match substantially with the distal end shapes of the belts (first and second belts 66 , 68 ), are formed as a pair on the outside surface of the proximal end side tubular portion 152 . The distal ends of the belts are connected and fixed in the cutout portions 158 by fixing pins 160 . [0100] As shown in FIG. 8 , the distal end working unit 14 includes a bending portion 34 that carries out the yawing operation of the gripper 12 (see FIG. 7 ) on a proximal end side with respect to the outer shell member 32 . Four of the joint members 36 A through 36 D from among the five joint members 36 A through 36 E that make up the bending portion 34 are each equipped with a center tubular portion 162 (tubular portion), which is formed in a tubular shape in a central region thereof, distal end hinge pieces 164 , which extend toward the distal end side from the center tubular portion 162 , and proximal end hinge pieces 166 , which extend toward the proximal end side from the center tubular portion 162 . The center tubular portion 162 includes a hollow part 162 a (see FIG. 14A ) in a central portion thereof that penetrates in the axial direction. [0101] The distal end hinge pieces 164 are formed to extend inwardly more than the proximal end hinge pieces 166 . Each of the adjacent joint members 36 are connected such that the distal end hinge pieces 164 and the proximal end hinge pieces 166 overlap one another. Further, hinge holes 168 are formed in both the distal end hinge pieces 164 and the proximal end hinge pieces 166 , and joint pins 170 are inserted in the hinge holes 168 in a state in which the distal end hinge pieces 164 and the proximal end hinge pieces 166 overlap. Consequently, the hinge members 38 are constructed such that the adjacent joint members 36 are mutually connected bendably about the joint pins 170 . Further, the distal end hinge pieces 164 of the joint member 36 A on the furthest most distal end side are connected in a bendable fashion to the outer shell member side hinge pieces 156 of the outer shell member 32 . [0102] On the other hand, although the joint member 36 E on the furthest most proximal end side includes the center tubular portion 162 and the distal end hinge pieces 164 in the same manner as the joint members 36 A through 36 D, the joint member 36 E is not provided with the proximal end hinge pieces 166 on the proximal end side of the center tubular portion 162 , and includes a fitting extension 172 , which is formed with an outer diameter matching substantially with the inner diameter of the outer tube 84 . The fitting extension 172 of the joint member 36 E is fitted into and fixed to the outer tube 84 . [0103] The flexible hollow tube 82 is inserted through the hollow parts 162 a of the five joint members 36 . The hollow tube 82 is formed with a predetermined inner diameter (e.g., 1.5 mm), and includes a hollow portion 82 a that penetrates through the hollow tube 82 in the axial direction. The first connector 142 is connected to the distal end of the hollow tube 82 , and a second connector 174 is connected to a proximal end of the hollow tube 82 . The second connector 174 , similar to the first connector 142 , includes a flange 176 disposed at an intermediate location, a distal end connecting projection 178 that extends toward the distal end from the flange 176 , and a proximal end connecting projection 180 that extends toward the proximal end from the flange 176 . The distal end connecting projection 178 of the second connector 174 is inserted into the hollow tube 82 , and the proximal end connecting projection 180 of the second connector 174 is inserted into the inner tube 86 , thereby connecting the hollow tube 82 and the inner tube 86 to each other. [0104] Further, the belts (the first and second belts 66 , 68 ) are inserted through the bending portion 34 along inner side surfaces of the five joint members 36 . Reinforcing plates 182 are bonded to inner sides of the first and second belts 66 , 68 , and the first and second belts 66 , 68 extend in the axial direction. The distal ends of the first and second belts 66 , 68 are connected to (the cutout portions 158 of) the outer shell member 32 , whereas the proximal ends thereof are connected to the first and second semicircular pipes 70 , 72 that are arranged between the outer tube 84 and the inner tube 86 . The first and second belts 66 , 68 are slidable with respect to the joint members 36 , so that the outer shell member 32 on the distal end side can be tilted in lateral directions responsive to the sliding amount of the first and second belts 66 , 68 . [0105] The outer tube 84 and the inner tube 86 that make up the shaft 16 , and the first and second semicircular pipes 70 , 72 that are disposed therebetween, extend in the proximal end direction and are inserted into the handle 18 . As shown in FIG. 9 , the handle main body 40 of the handle 18 is constructed so as to be capable of being separated (into a right side casing 40 a and a left side casing 40 b , see FIG. 1 ) in the vertical direction (the left side casing 40 b is omitted from illustration in FIG. 9 ). Further, an insertion hole 42 a for insertion therein of the shaft 16 is formed on the distal end surface of the handle main body 40 . [0106] A first bracket 200 to which the proximal end of the shaft 16 (outer tube 84 ) is connected, and a second bracket 202 that confronts the first bracket 200 are arranged in the interior space of the handle main body 40 . The first bracket 200 is formed in a bent plate-like shape having a distal end surface and a right side surface, and the second bracket 202 is formed in a bent plate-like shape having an upper surface and a left side surface. A shaft insertion pipe 204 , which extends in the distal end direction, is disposed on the distal end surface of the first bracket 200 , and the shaft 16 is inserted into the shaft insertion pipe 204 in a condition in which the outer tube 84 , the semicircular pipes, and the inner tube 86 overlap. Further, by insertion of the shaft insertion pipe 204 into a through hole 50 a of the rotating handle 50 , the rotating handle 50 is mounted rotatably with respect to the first bracket 200 (i.e., the handle 18 ). [0107] The first and second slide members 74 , 76 are arranged at positions near an upper portion between the first and second brackets 200 , 202 . The first and second slide members 74 , 76 are substantially T-shaped as viewed from the side, and have bar portions 206 that extend in the distal end and proximal end directions, and attachment parts 208 that extend downwardly from the bar portions 206 . The above-described racks 78 are disposed on confronting surfaces of the pair of bar portions 206 . The bar portions 206 are disposed slidably in supporting cutouts 210 that are formed in the first bracket 200 . A stopper 212 , which regulates a movement limit of the proximal end side of the first and second slide members 74 , 76 , is disposed on the proximal end side of the first and second brackets 200 , 202 . [0108] On the other hand, confronting surfaces on the lower end side of the pair of attachment parts 208 are formed in arcuate shapes, and are capable of coming into intimate contact with outer surfaces of the first and second semicircular pipes 70 , 72 . Stated otherwise, the first semicircular pipe 70 is connected to the attachment part 208 of the first slide member 74 , and the second semicircular pipe 72 is connected to the attachment part 208 of the second slide member 76 . Consequently, the proximal end sides of the first and second semicircular pipes 70 , 72 are supported by the first and second slide members 74 , 76 , and the first and second semicircular pipes 70 , 72 extend in the distal end direction between the outer tube 84 and the inner tube 86 . [0109] The pinion 80 , which is disposed on the racks 78 between the first and second slide members 74 , 76 , is formed on the lower end of a pinion shaft 214 . The pinion shaft 214 extends upwardly and is inserted through a pinion hole 202 a provided in an upper surface of the second bracket 202 . On the pinion shaft 214 , a driven bevel gear 216 is fitted at a position located above the pinion 80 . The driven bevel gear 216 is formed with a toothed surface on an upper side surface (inclined surface) thereof, and a toothed surface of a main drive bevel gear 218 is arranged in meshed engagement with respect to the toothed surface of the driven bevel gear 216 . The main drive bevel gear 218 is connected to the distal end of a motor gear pin 220 , and a motor-driven driven gear 222 is disposed on the proximal end of the motor gear pin 220 . [0110] In a state in which the drive unit 41 is attached to the handle main body 40 , the motor-driven driven gear 222 is made to mesh with a motor-driven main drive gear 224 that projects from the distal end surface of the drive unit 41 . The drive motor 46 (see FIG. 11 ) is arranged in the interior of the drive unit 41 , and the motor-driven main drive gear 224 is driven rotatably by the drive motor 46 . By such a structure, based on the rotary drive from the drive motor 46 , the first and second slide members 74 , 76 are made to move slidably in the distal end and proximal end directions, whereby the first and second semicircular pipes 70 , 72 connected thereto are operated. [0111] Further, the above-described switches 48 are disposed respectively on the right side surface of the first bracket 200 and on the left side surface of the second bracket 202 . The switches 48 are exposed to the outside from windows 42 b that are formed on side surfaces of the handle main body 40 (see FIG. 1 ). Non-illustrated electrical circuits, which are capable of sensing the operating state of the switches 48 , are printed on outer side surfaces of the first and second brackets 200 , 202 that are in contact with both ends of the switches 48 . Further, a second signal connector (not shown) is disposed in the interior of the handle 18 . The second signal connector is electrically connected to the aforementioned electrical circuits, and when the drive unit 41 is mounted, the second signal connector is connected to a first signal connector (not shown) of the drive unit 41 . The manipulator 10 is constructed such that, by the connections of the first and second signal connectors, power is supplied to the electrical circuits, and operating signals (voltage values), which are generated by operating the switches 48 , are transmitted to the external controller 20 . Based on the operating signals, the controller 20 supplies power (signals) for rotating the drive motor 46 . [0112] Incidentally, the inner tube 86 , which is covered by the first and second semicircular pipes 70 , 72 , extends in the proximal end direction more than the attachment parts 208 of the first and second slide members 74 , 76 . A rotary driven gear 226 , which constitutes a portion of the rotation mechanism 88 , and a sliding drive shaft 228 (rotating shaft member), which constitutes a portion of the advancing and retracting movement mechanism 98 , are mounted on a proximal end side surface of the inner tube 86 . [0113] The rotary driven gear 226 extends a predetermined axial length (e.g., 6 mm), and a toothed surface, which is formed on the outer side surface thereof, meshes with a toothed surface of a rotary main drive gear 230 , which is arranged on the lower side of the rotary driven gear 226 . The rotary main drive gear 230 is connected and fixed to the proximal end of a rotating pin 232 . The rotating pin 232 is axially supported rotatably by a retaining projection 234 that projects from the plate surface of the first bracket 200 . Further, a handle-driven gear 236 is formed on the distal end of the rotating pin 232 . The handle-driven gear 236 is arranged in front of the distal end surface of the first bracket 200 . A toothed surface of the handle-driven gear 236 is enmeshed with a toothed surface of a handle main drive gear 238 , which is disposed on the proximal end side of the rotating handle 50 and is arranged inside the body portion 42 . By constructing the rotation mechanism 88 in this manner, the inner tube 86 is made to rotate about its axis based on a rotating operation of the rotating handle 50 . [0114] On the other hand, the sliding drive shaft 228 that is mounted on the inner tube 86 includes a head part 240 that is expanded radially outward on the distal end side, and a shank part 242 that extends a predetermined length toward the proximal end side from the head part 240 . A recessed portion 244 (groove) is formed along the circumferential direction on an outer side surface of the head part 240 , and projecting portions 248 (protrusion) of a responsive member 246 (moving body), which is arranged on the lower side of the sliding drive shaft 228 , is inserted into the recessed portion 244 . [0115] The responsive member 246 is made up from a block body which is formed in an oval shape as viewed from the side, and a pair of arms 250 that extend from an upper portion of the block body. The projecting portions 248 are formed on inner side surfaces, respectively, of upper end sides of the pair of arms 250 . Further, on a side surface of the responsive member 246 , two holes (an upper side hole 246 a and a lower side hole 246 b ) are formed. The upper side hole 246 a is pivotally supported by a first support pin 252 that extends from the first bracket 200 . Accordingly, the responsive member 246 is capable of rotating about the upper side hole 246 a (first support pin 252 ). On the other hand, a spring link 256 is connected to the lower side hole 246 b through a first link shaft 254 . [0116] The spring link 256 includes a zigzag-shaped spring member 258 in a central portion, together with two holes (front side hole 256 a , rear side hole 256 b ) formed on both ends thereof. The aforementioned first link shaft 254 is inserted in the rear side hole 256 b , and a second link shaft 260 is inserted in the front side hole 256 a . The second link shaft 260 is connected to an upper end of the trigger 52 . [0117] The trigger 52 is constituted from an extending handle 262 , which extends downwardly in a bifurcated form, and a linkage 264 , which projects from an upper portion of the extending handle 262 , and in which two holes (link hole 264 a , support hole 264 b ) are formed to penetrate. The aforementioned second link shaft 260 is inserted into the link hole 264 a . On the other hand, the support hole 264 b is pivotally supported on a second support pin 266 that extends from the first bracket 200 . Accordingly, the trigger 52 is capable of rotating about the support hole 264 b (second support pin 266 ). By constructing the advancing and retracting movement mechanism 98 in this manner, the sliding drive shaft 228 is made to move in the distal end and proximal end directions, based on a pulling operation and a pushing operation of the trigger 52 . As a result, advancing and retracting movements of the inner tube 86 can be implemented. [0118] Further, a rotating part of a slip ring system 270 is disposed on the shank part 242 of the sliding drive shaft 228 . The slip ring system 270 is a mechanism to continuously establish an electrical connection between the high frequency power source 22 and the conductive line 60 (the two metal members 56 ) arranged inside the inner tube 86 , even while the inner tube 86 is being rotated by the rotation mechanism 88 . More specifically, a first resin tube 272 , a first cylindrical terminal 62 a , a second resin tube 274 , a second cylindrical terminal 62 b , an insulating washer 276 , and a nut 278 are mounted externally with respect to the shank part 242 of the sliding drive shaft 228 . The first cylindrical terminal 62 a is mounted on an outer side surface of the first resin tube 272 , with one of the metal members 56 (e.g., a positive terminal) being connected to the interior thereof. The second cylindrical terminal 62 b is mounted on an outer side surface of the second resin tube 274 , with the other of the metal members 56 (e.g., a negative terminal) being connected to the interior thereof. The first and second contact terminals 64 a , 64 b abut respectively against side surfaces of the first and second cylindrical terminals 62 a , 62 b , and the first and second contact terminals 64 a , 64 b are connected to the high frequency power source 22 . Consequently, in the slip ring system 270 , the first and second contact terminals 64 a , 64 b continue to remain in abutment, even if the first and second cylindrical terminals 62 a , 62 b are rotating. Thus, the output from the high frequency power source 22 is supplied to the metal members 56 . [0119] FIG. 10 is a schematic plan view for describing the yawing operation of the manipulator 10 of FIG. 1 , FIG. 11 is a partial perspective view for describing the yawing operation of the manipulator 10 of FIG. 1 , and FIG. 12 is a partial perspective view for describing an assembled condition in the interior of the handle 18 of FIG. 1 . [0120] Next, a structure in relation to the yawing operation of the manipulator 10 according to the present embodiment will be described in greater detail. As shown in FIGS. 9 and 10 , on the handle 18 , two switches 48 (right side switch 48 a , left side switch 48 b ) are mounted on opposite side surfaces of the handle main body 40 . Center portions of the right side and left side switches 48 a , 48 b are supported on the handle 18 (by the first and second brackets 200 , 202 ), and a structure is provided such that both end portions (a distal end portion and a proximal end portion) thereof are displaced about the center portions in response to pushing operation of the switches by the user. The right side and left side switches 48 a , 48 b are structured to be capable of being handled by both left-handed and right-handed users. For example, in the case that the gripping unit 44 is gripped by the right hand, the right side switch 48 a can be operated by the index finger of the right hand. [0121] The right side switch 48 a is constituted such that, in the case that the proximal end side (A1 in FIG. 10 ) thereof is pressed, the distal end working unit 14 undergoes a yawing operation in a rightward direction (Y1 direction), and in the case that the distal end side (A2 in FIG. 10 ) thereof is pressed, the distal end working unit 14 undergoes a yawing operation in a leftward direction (Y2 direction). On the other hand, the left side switch 48 b is constituted such that, in the case that the proximal end side (A2 in FIG. 10 ) thereof is pressed, the distal end working unit 14 undergoes a yawing operation in a leftward direction (Y2 direction), and in the case that the distal end side (A1 in FIG. 10 ) thereof is pressed, the distal end working unit 14 undergoes a yawing operation in a rightward direction (Y1 direction). Owing to such a structure, whichever switch, i.e., the right side switch 48 a or the left side switch 48 b , the user operates, the feeling of operation of the switches 48 matches with the sense (viewpoint) of the user. [0122] Stated otherwise, the operating signals that are generated by operating the switches 48 are of two patterns, i.e., a yawing operation signal in the left direction and a yawing operation signal in the right direction, and the signals are transmitted to the controller 20 (see FIG. 11 ). The controller 20 outputs, to the drive motor 46 , a drive signal based on the operating signal for controlling the rotational speed, the rotational direction, etc. of the drive motor 46 . Based on the drive signal from the controller 20 , rotation of the drive motor 46 is carried out in the form of a clockwise rotation or a counterclockwise rotation. The driving control of the drive motor 46 may adopt various configurations. For example, configurations may be adopted in which, corresponding to the pressing force applied to the switches 48 , the rotational speed of the drive motor 46 is varied, or the bending speed of the yawing operation is varied. [0123] As shown in FIGS. 11 and 12 , the manipulator 10 is constructed such that, by attaching the drive unit 41 to the handle main body 40 , the motor-driven main drive gear 224 that is mounted on the distal end of the drive motor 46 meshes with the motor-driven driven gear 222 in the interior of the handle 18 . The motor gear pin 220 , which is equipped with the motor-driven driven gear 222 , is retained rotatably by a first support bar 280 and a second support bar 282 , which are erected upwardly from the proximal end side of the second bracket 202 . The first support bar 280 includes an upper end portion which extends in the direction of the distal end and holds an upper end of the pinion shaft 214 . The pinion shaft 214 is rotated by the driven bevel gear 216 , which abuts against the main drive bevel gear 218 that is disposed on the distal end of the motor gear pin 220 , so as to rotate the pinion 80 that is formed on the lower end of the driven bevel gear 216 . [0124] The pinion 80 is arranged in a space that is formed by assembly of the first and second brackets 200 , 202 . The first and second slide members 74 , 76 are disposed in confronting relation sandwiching the pinion 80 . The bar portions 206 of the first and second slide members 74 , 76 are supported in the supporting cutouts 210 (see FIG. 9 ) of the first bracket 200 . The first and second semicircular pipes 70 , 72 are connected respectively to the attachment parts 208 that extend downwardly from the bar portions 206 . Therefore, when the pinion 80 is rotated in one direction, the first slide member 74 and the second slide member 76 slide mutually in opposite directions, accompanied by the first semicircular pipe 70 and the second semicircular pipe 72 also sliding mutually in opposite directions. Sliding of the first and second semicircular pipes 70 , 72 in opposite directions is transferred through the shaft 16 to the distal end working unit 14 on the distal end side. [0125] FIG. 13A is a side view showing main components of the bending portion 34 of the manipulator 10 of FIG. 1 , FIG. 13B is a plan view showing main components of the bending portion 34 of the manipulator 10 , and FIG. 13C is a cross sectional view taken along line XIIIC-XIIIC of FIG. 13B . FIG. 14A is a partial perspective view showing at an enlarged scale one of the joint members 36 of FIG. 13A , and FIG. 14B is a partial perspective view showing at an enlarged scale an assembled condition of the joint members 36 . [0126] As shown in FIGS. 13A and 13B , with the bending portion 34 , the first and second belts 66 , 68 , which are connected to the distal ends of the first and second semicircular pipes 70 , 72 , are inserted through the five joint members 36 , and are connected by fixing pins 160 to the outer shell member 32 on the distal end side. During the yawing operation, by sliding movement of the first and second belts 66 , 68 in opposite directions, since one of the belts becomes shorter and the other of the belts becomes longer, the bending portion 34 is subjected to a bending operation. For implementing the bending operation, a structure is provided in which the first and second belts 66 , 68 slide along inner side surfaces of the joint members 36 . [0127] As shown in FIG. 14A , guide members 283 that serve to guide the first and second belts 66 , 68 are disposed in the center tubular portions 162 of the joint members 36 on an outer side of the hollow parts 162 a of the center tubular portions 162 . The guide members 283 comprise belt spaces 286 (penetrating cavities) that penetrate in the axial direction through the center tubular portion 162 , and projecting walls 284 that act as separations between the hollow parts 162 a and the belt spaces 286 . The projecting walls 284 are erected in the hollow parts 162 a perpendicularly to the distal end and proximal end hinge pieces 164 , 166 , which extend in pairs on upper and lower parts of the center tubular portion 162 . The first and second belts 66 , 68 are mounted so as to be inserted through the belt spaces 286 that are separated by the projecting walls 284 (see FIG. 14B ). [0128] On the other hand, the distal end hinge pieces 164 and the proximal end hinge pieces 166 are formed at positions shifted by 90° with respect to the belt spaces 286 through which the first and second belts 66 , 68 are inserted. Accordingly, the distal end hinge pieces 164 and the proximal end hinge pieces 166 are bendably connected by the joint pins 170 , and the adjacent joint members 36 are easily bent about the joint pins 170 responsive to sliding of the first and second belts 66 , 68 . Further, in the case that the first and second belts 66 , 68 are slid (i.e., in the event that the bending portion 34 is subjected to bending), the first and second belts 66 , 68 can avoid becoming separated from the inner side surfaces of the center tubular portions 162 by the projecting walls 284 , and corresponding to the sliding amount, the joint members 36 can be bent together in conjunction. [0129] Furthermore, arcuate surfaces 288 through which the hollow tube 82 can be inserted are formed on upper and lower inside surfaces of the joint members 36 . In the event that the joint members 36 are bent, the hollow tube 82 bends in following relation thereto as a result of being guided by the arcuate surfaces 288 . [0130] The hollow tube 82 is flexible and is capable of being bent in following relation to the bending movement of the bending portion 34 , and as shown in FIG. 13C , a hollow portion 82 a is formed therein having an inner diameter that enables insertion of the conductive line 60 . The second connector 174 is connected to the proximal end side of the hollow portion 82 a , and the first connector 142 is connected to the distal end side of the hollow portion 82 a. [0131] Further, a double coil (a first coil 290 , a second coil 292 ) is arranged in the interior of the hollow tube 82 to surround the hollow portion 82 a . The first and second coils 290 , 292 extend axially in an overlapping manner in a state of being wound mutually in different (clockwise, counterclockwise) winding directions. Consequently, when the hollow tube 82 is rotated clockwise, the coil (e.g., the first coil 290 ) that is wound in the clockwise direction expands in diameter, and the coil (e.g., the second coil 292 ) that is wound in the counterclockwise direction is reduced in diameter. Therefore, the shape of the double coil overall is maintained. As a result, even if the hollow tube 82 is rotated in a state in which the hollow tube 82 is bent by the bending portion 34 , the rotational torque thereof can easily be transmitted to the distal end side (the gripper 12 ). [0132] By constructing the manipulator 10 to include the distal end working unit 14 and the handle 18 , as described above, the gripper 12 can be tilted in lateral directions by the yawing operation. For example, as shown in FIG. 11 , in the event that the gripper 12 is to be tilted in a rightward direction, the user presses the proximal end A1 of the right side switch 48 a (or the distal end A1 of the left side switch 48 b ) (see FIG. 10 ), whereby an operating signal from the switch 48 is sent to the controller 20 . The controller 20 receives the operating signal and outputs, to the drive motor 46 , a predetermined drive signal (electric power), and then the controller 20 rotates the motor-driven main drive gear 224 of the drive motor 46 in a clockwise direction. As a result, the motor gear pin 220 (and the motor-driven driven gear 222 ) is rotated in a counterclockwise direction, and the driven bevel gear 216 (and the pinion shaft 214 ), which is enmeshed with the main drive bevel gear 218 , is rotated in a clockwise direction as viewed in plan. Accordingly, the pinion 80 is rotated clockwise, whereupon the first slide member 74 is made to slide in the proximal end direction, and the second slide member 76 is made to slide in the distal end direction. [0133] Accompanying movement of the first slide member 74 in the proximal end direction, the first semicircular pipe 70 and the first belt 66 also undergo sliding movement in the proximal end direction. Further, accompanying movement of the second slide member 76 in the distal end direction, the second semicircular pipe 72 and the second belt 68 also undergo sliding movement in the distal end direction. Accordingly, in the bending portion 34 , since the axial length of the first belt 66 becomes shorter, whereas the axial length of the second belt 68 becomes longer, the bending portion 34 undergoes a yawing operation and is bent on the side of the first belt 66 . As a result, the gripper 12 , which is disposed on the distal end side of the bending portion 34 , is changed to a rightward tilted posture. [0134] The bending portion 34 may be constructed such that, during bending of the bending portion 34 , the sliding amounts of the first and second belts 66 , 68 are changed responsive to the bending direction. More specifically, in the case that the bending portion 34 is bent, the length of the belt (first belt 66 ) on the inside of the bending direction becomes shorter than the belt on the outside (second belt 68 ) by an amount that is more than necessary. For this reason, a structure may be provided in which, by interposing non-illustrated gears between the pinion 80 and the racks 78 of the first and second slide members 74 , 76 without the pinion 80 meshing directly with the racks 78 , the sliding amount of the belt on the inside of the bending direction (i.e., the first belt 66 in the case of the right side, the second belt 68 in the case of the left side) can be reduced. [0135] FIG. 15 is a schematic side view for describing the rolling operation of the manipulator 10 of FIG. 1 , and FIG. 16 is a partial perspective view for describing an assembled condition in the interior of the handle 18 of FIG. 1 . [0136] Next, a structure in relation to the rolling operation of the manipulator 10 according to the present embodiment will be described in greater detail. As shown in FIG. 15 , by the rolling operation, the gripper 12 on the distal end of the manipulator 10 is rotated about the axis Or of the gripper 12 . In the present embodiment, the axis Or of the gripper 12 (end effector) is defined by the center axis of a portion that extends substantially in a straight line on the distal end side of the bending portion 34 (joint part). The axis Or is tilted in the yawing direction with respect to the axis Os of the shaft 16 (see FIG. 4B ). [0137] The rolling operation is implemented by the user manually operating the rotating handle 50 that is mounted on the distal end of the handle 18 . The rotating handle 50 is a block shaped member having a width that is smaller than the width of the handle 18 as viewed in plan (see FIG. 10 ). The shaft insertion pipe 204 of the first bracket 200 is inserted into the through hole 50 a that is provided in the center thereof (see FIG. 9 ). Further, plural blades 50 b that make the rotating operation easier for the user are provided on side surfaces of the rotating handle 50 . [0138] As shown in FIGS. 15 and 16 , a latch gear 294 and a handle main drive gear 238 , which rotates together with the rotating handle 50 , are disposed on the proximal end side of the rotating handle 50 . The latch gear 294 and the handle main drive gear 238 are disposed in a distal end part of an interior space of the handle 18 . The outer side surface of the latch gear 294 is formed in a wavelike shape (irregular surface) by arc-shaped valley portions 296 , and mountain portions 298 that bulge upwardly between the valley portions 296 . A latch piece 300 is configured to abut against the outer side surface of the latch gear 294 . [0139] The latch piece 300 includes a mounting portion 304 , which is attached to a mounting plate 302 that extends in the distal end direction from the second bracket 202 , and an elastic piece 306 that extends obliquely downward from the mounting portion 304 and is capable of swinging elastically with respect to the mounting portion 304 (see FIG. 9 ). The lower end of the elastic piece 306 is formed in an arcuate shape that matches with the valley portions 296 of the latch gear 294 , and in a mounted state of the latch piece 300 , is in surface contact with the valley portions 296 . When the rotating handle 50 is rotated, the latch gear 294 also rotates, and by such rotation, the latch piece 300 (the elastic piece 306 ) swings elastically along the valley portions 296 and the mountain portions 298 . When the elastic piece 306 overcomes the mountain portions 298 and moves into the valley portions 296 , a positive displacement takes place due to the elastic force thereof, and the displacement of the latch piece 300 is transmitted as a tactile sensation to the user that operates the rotating handle 50 . Furthermore, along with displacement of the latch piece 300 , since operating noise is generated, the operational feeling of the rotating handle 50 can be recognized more strongly by the user. Consequently, the user can perform the rotating operation of the rotating handle 50 more intuitively. [0140] The handle main drive gear 238 rotates the rotating pin 232 (handle-driven gear 236 ) that is supported on the first bracket 200 . The handle-driven gear 236 is formed with a smaller outer diameter than the handle main drive gear 238 , and is rotated at a greater amount of rotation than the amount of rotation of the rotating handle 50 . The rotary main drive gear 230 , which is disposed on the proximal end side of the rotating pin 232 , rotates the rotary driven gear 226 that is fixed to the inner tube 86 of the shaft 16 , and the rotary driven gear 226 is rotated integrally with the inner tube 86 . [0141] Further, the sliding drive shaft 228 and the slip ring system 270 (excluding the first and second contact terminals 64 a , 64 b ), which are mounted more on the proximal end side than the rotary driven gear 226 , rotate together with the inner tube 86 . The first and second contact terminals 64 a , 64 b abut elastically against the first and second cylindrical terminals 62 a , 62 b , so as to remain in contact therewith even though the first and second cylindrical terminals 62 a , 62 b are rotating. Thus, steady electrical conduction is realized between the high frequency power source 22 and the conductive line 60 that is arranged in the interior of the inner tube 86 . [0142] FIG. 17 is a perspective view, partially cut away, of main components of a distal end part of the manipulator 10 of FIG. 1 , FIG. 18A is a cross sectional plan view showing a distal end part of the manipulator 10 of FIG. 1 , and FIG. 18B is a cross sectional side view showing a distal end part of the manipulator 10 of FIG. 1 . [0143] As shown in FIG. 17 , the distal end working unit 14 is constituted such that the gripper 12 rotates in the circumferential direction on the distal end side of the bending portion 34 . More specifically, by connecting the outer shell member 32 to the distal end of the joint members 36 that constitute the bending portion 34 , a structure is provided in which the outer shell member 32 does not rotate. On the other hand, by transferring the rotational torque from the hollow tube 82 that is disposed in the interior of the bending portion 34 , a structure is provided in which the gripper 12 and the gripper retaining member 30 are rotated in the circumferential direction about the axis of the gripper 12 . [0144] More specifically, the hollow tube 82 is connected through the second connector 174 to the inner tube 86 of the shaft 16 , whereby the inner tube 86 rotates together with the hollow tube 82 (see FIG. 13C ). As shown in FIGS. 18A and 18B , the distal end of the hollow tube 82 is inserted into the engagement tubular portion 114 of the gripper retaining member 30 , and is fitted and connected to the proximal end connecting projection 148 of the first connector 142 . Further, the distal end connecting projection 146 of the first connector 142 is fitted into the cylindrical body 138 . [0145] The cylindrical body 138 is formed with an outer diameter that matches substantially with the inner diameter of the engagement tubular portion 114 . To the engagement tubular portion 114 , the rotational torque is transferred from the cylindrical body 138 that is connected to the hollow tube 82 . More specifically, when the hollow tube 82 is rotated and the rotational torque therefrom is transmitted, the first connector 142 and the cylindrical body 138 rotate together integrally, and the gripper retaining member 30 (the engagement tubular portion 114 ) is rotated accompanying rotation of the cylindrical body 138 . [0146] The insertion part 134 of the aforementioned moving body 94 is inserted in a distal end portion of the cylindrical body 138 . The retaining plate 128 a at the center of the moving body 94 is made of an insulating material, and the retaining plate 128 a extends to the proximal end side of the insertion part 134 , with welded portions 308 being provided on both upper and lower surfaces of the proximal end part thereof. The metal members 56 (metal wires), which are exposed from the distal end of the conductive line 60 , are welded by a welding material to the welded portions 308 . The conductive line 60 extends in the axial direction in the hollow portion 82 a of the hollow tube 82 while a distal end part thereof is fixedly retained by the first connector 142 . By fitting the insertion part 134 in the cylindrical body 138 , the moving body 94 rotates along with the rotation of the cylindrical body 138 . Also, by transmitting rotation of the moving body 94 to the gripper retaining member 30 , the gripper retaining member 30 is rotated more smoothly. [0147] Because the first and second gripper members 26 , 28 that make up the gripper 12 are supported by the gripper retaining member 30 , the first and second gripper members 26 , 28 rotate together with rotation of the gripper retaining member 30 . More specifically, in the manipulator 10 , as shown in FIG. 17 , the gripper 12 , the gripper retaining member 30 , and the hollow tube 82 are rotated about the axis Or of the gripper 12 . [0148] In particular, in the manipulator 10 according to the present embodiment, the rolling operation of the gripper 12 enables the gripper 12 to be rotated through a 360° unlimited range of rotation with respect to the axis Or of the gripper 12 . More specifically, the inner tube 86 is rotatable in an unlimited manner with respect to the outer tube 84 , and the hollow tube 82 , which is arranged at a position overlapping with the bending portion 34 , also is rotatable in an unlimited manner. Similarly, the gripper retaining member 30 (gripper 12 ), which is inserted in the outer shell member 32 , is rotatable in an unlimited manner. Further, since the conductive line 60 extends inside the hollow tube 82 and the inner tube 86 , the conductive line 60 rotates together with the hollow tube 82 and the inner tube 86 . At this time, conduction of electricity with the high frequency power source 22 at the proximal end side of the conductive line 60 is continued by the slip ring system 270 . [0149] FIG. 19 is a schematic perspective view for describing the opening and closing operation of the gripper 12 of FIG. 1 , FIG. 20A is a first side view for describing operations on the side of the handle 18 of FIG. 19 , and FIG. 20B is a second side view for describing operations on the side of the handle 18 of FIG. 19 . [0150] Next, a structure in relation to the opening and closing operation of the gripper 12 of the manipulator 10 according to the present embodiment will be described in greater detail. As shown in FIG. 19 , by the opening and closing operation, distal end portions (serrated meshing teeth 100 ) of the first and second gripper members 26 , 28 of the gripper 12 are made to approach and separate away from each other. The opening and closing operation is implemented by the user manually operating the trigger 52 of the handle 18 . [0151] As shown in FIGS. 20A and 20B , the trigger 52 is arranged on the lower side of the rotating pin 232 that makes up the rotation mechanism 88 , and is supported swingably with respect to the first bracket 200 (handle 18 ). More specifically, the linkage 264 of the trigger 52 is supported by the second support pin 266 that extends from the first bracket 200 , and the extending handle 262 is operated in the distal end and proximal end directions about the second support pin 266 . [0152] The linkage 264 of the trigger 52 is connected to the advancing and retracting movement mechanism 98 that operates the inner tube 86 . More specifically, a distal end of the spring link 256 is connected through the second link shaft 260 to an upper portion (link hole 264 a ) above the insertion position of the second support pin 266 of the linkage 264 . The spring link 256 is arranged to extend in the proximal end direction, and the proximal end thereof is connected through the first link shaft 254 to a lower end portion (lower side hole 246 b ) of the responsive member 246 . The first support pin 252 that extends from the first bracket 200 is inserted into the upper side hole 246 a of the responsive member 246 , and the projecting portion 248 (see FIG. 9 ) of the pair of arms 250 that extend upwardly above the upper side hole 246 a is inserted into the recessed portion 244 of the sliding drive shaft 228 . [0153] Consequently, when the extending handle 262 of the trigger 52 is pulled in the proximal end direction, the trigger 52 rotates about the second support pin 266 , and the upper end (the connection location of the spring link 256 ) of the linkage 264 is moved in the direction of the distal end. Along therewith, the spring link 256 also moves in the distal end direction, whereby the lower end of the responsive member 246 is made to move in the distal end direction. By the lower end moving in the distal end direction, the responsive member 246 rotates about the first support pin 252 , and the arms 250 on the upper end side are made to move in the direction of the proximal end. Accordingly, the sliding drive shaft 228 (recessed portion 244 ) is pressed by the projecting portion 248 and moves in the direction of the proximal end. As a result, the inner tube 86 moves in the proximal end direction together with the sliding drive shaft 228 , and the operating force in the proximal end direction is transferred through the shaft 16 to the distal end working unit 14 on the distal end side. [0154] Moreover, in the event that the extending handle 262 of the trigger 52 is operated by being pulled, the spring member 258 of the spring link 256 expands elastically, and serves to suppress movement of the inner tube 86 in the proximal end direction. Stated otherwise, the movement amount when the inner tube 86 is moved in the proximal end direction is limited to the degree at which the gripper 12 shifts to the closed state from the open state, and in the case that the trigger 52 is pulled beyond the above degree, the operating force is absorbed by elastic deformation of the spring member 258 . As a result, application of a large torque during the closing operation of the gripper 12 can be avoided. For example, movement of the inner tube 86 in the proximal end direction is of a degree that enables transitioning from the condition shown in FIG. 20A to the condition shown in FIG. 20B . [0155] The axial length of the rotary driven gear 226 and the two cylindrical terminals 62 , which are mounted on the inner tube 86 , is set to be longer than the movement amount in advancing and retracting directions of the inner tube 86 . Therefore, even in the case that the trigger 52 is operated and the inner tube 86 is moved in the proximal end direction, the rotary main drive gear 230 can mesh continuously with the rotary driven gear 226 , and the first and second contact terminals 64 a , 64 b can remain in contact continuously with the first and second cylindrical terminals 62 a , 62 b . Consequently, while the inner tube 86 undergoes rotation (i.e., while the rolling operation of the gripper 12 is carried out), opening and closing of the gripper 12 can be performed, and current can be supplied to energize the treatment target X. [0156] FIG. 21A is a principal plan view showing the gripper 12 of FIG. 1 , FIG. 21B is a partial plan view showing an open state of the gripper 12 , and FIG. 21C is a partial plan view showing a closed state of the gripper 12 . The operating force that moves the inner tube 86 in the distal end and proximal end directions is transmitted to the hollow tube 82 , which is connected to the distal end of the inner tube 86 , whereby the hollow tube 82 is made to move in the distal end and proximal and directions. The cylindrical body 138 is connected through the first connector 142 to the distal end of the hollow tube 82 , and the cylindrical body 138 also is made to move together with the hollow tube 82 . [0157] The length in the axial direction of the hollow tube 82 is longer than the axial length of the bending portion 34 of the distal end working unit 14 , such that even if the hollow tube 82 is advanced and retracted, the hollow tube 82 is arranged to overlap with the bending portion 34 at all times. Accordingly, even if the bending portion 34 is subjected to bending as shown in FIG. 11 , and the hollow tube 82 bends in following relation thereto, the hollow tube 82 can be advanced and retracted along the bend, and the operating force of the advancing and retracting movement can be transmitted to the cylindrical body 138 that is connected to the distal end side of the hollow tube 82 . [0158] As shown in FIG. 18A , connecting pins 310 a , 310 b , which project inwardly (into the hollow space 140 ) by a predetermined amount, are disposed on the distal end side and the proximal end side of the cylindrical body 138 . The first connector 142 is equipped with a first connector side engagement groove 312 , which is engraved in a circumferential direction in a root portion of the distal end connecting projection 146 . The proximal end side connecting pin 310 a is inserted into the first connector side engagement groove 312 . Further, the moving body 94 is equipped with a moving body side engagement groove 314 , which is engraved in a circumferential direction in the insertion part 134 that projects in the proximal end direction. The distal end side connecting pin 310 b is inserted into the moving body side engagement groove 314 . By this structure, the axial connections between the first connector 142 , the cylindrical body 138 , and the moving body 94 are reinforced by the connecting pins 310 a , 310 b , and the operating force of the advancing and retracting movement, which is transmitted from the hollow tube 82 , is further transmitted reliably to the moving body through the cylindrical body 138 . [0159] On the other hand, the gripper retaining member 30 is placed in a condition in which the moving body 94 is arranged in the sliding space 122 thereof, and the gripper retaining member 30 remains fixed with respect to movements of the moving body 94 in the distal end and proximal end directions. More specifically, by engagement between the projection 120 , which is formed on the outer side surface of the engagement tubular portion 114 , and the groove 154 , which is formed on the inner side surface of the outer shell member 32 , the gripper retaining member 30 is placed in a fixed state in which back and forth movement thereof is restricted, in contrast to the advancing and retracting movements of the moving body 94 . [0160] In the moving body 94 , the first and second gripper members 26 , 28 are sandwiched between the gaps 130 of (the three-pronged moving body side section 132 of) the distal end, and the movable pin 96 , which is inserted in the long holes 92 of the extension pieces 90 , is retained therein. As shown in FIGS. 21A through 21C , in a condition in which the moving body 94 is positioned on the distal end side of the sliding space 122 , the movable pin 96 is moved to the distal end side of the long holes 92 , and the distal end portions of the first and second gripper members 26 , 28 are separated and placed in an open condition. [0161] With respect to the open condition, when the inner tube 86 is moved in the proximal end direction by a pulling operation of the trigger 52 , an operating force in the proximal end direction is transmitted to the moving body 94 via the inner tube 86 , the second connector 174 , the hollow tube 82 , the first connector 142 , and the cylindrical body 138 . At this time, the first connector 142 , the cylindrical body 138 , and the moving body 94 are connected by the connecting pins 310 a , 310 b , whereby the operating force in the proximal end direction is transferred smoothly. When the moving body 94 is moved in the proximal end direction, the movable pin 96 moves in the proximal end direction while guiding the long holes 92 , and based on the guiding of the long holes 92 , the distal end parts of the first and second gripper members 26 , 28 are made to approach one another mutually, and a closed condition can be obtained. [0162] Further, as discussed above, in the close state of the gripper 12 , a current supplying condition is formed by the connection of the first and second gripper members 26 , 28 , which are of different polarities. More specifically, in a state in which the treatment target X is sandwiched between the first and second gripper members 26 , 28 , an output, which is supplied to the first and second gripper members 26 , 28 through the conductive line 60 from the high frequency power source 22 , is supplied to the treatment target X, and a predetermined process (cauterization by application of heat, or the like) is performed thereon. [0163] In the foregoing manner, by means of the manipulator 10 according to the present embodiment, the hollow tube 82 that is disposed in a position overlapping with the bending portion 34 bends in following relation with the yawing operation of the bending portion 34 . Therefore, for example, even in the case that the treatment target X is located deeply inside the living body, the posture (inclination) of the gripper 12 can easily be changed, and the gripper 12 can be delivered smoothly to the treatment target X. [0164] Further, in the distal end working unit 14 , an operating force in the direction of rotation is transmitted to the gripper 12 by the hollow tube 82 , whereby the gripper 12 is rotated (subjected to a rolling operation) through an unlimited range of rotation. Therefore, the posture of the gripper 12 (i.e., a posture in the direction of rotation around the roll axis Or of the gripper 12 ) on the distal end side of the bending portion 34 can be changed freely, and the orientation of the gripper 12 can be changed any number of times to match with the treatment target X, and to enable an accurate treatment to be carried out on the treatment target X. [0165] Further, by constructing the bending portion 34 from the plural (five) joint members 36 , the bending portion 34 can be bent gently and gradually. Therefore, the hollow tube 82 , which is disposed at a position overlapping with the bending portion 34 , can easily follow the bending movement of the bending portion 34 . In addition, since the hollow tube 82 extends a greater length than the bending portion 34 , the operating force in the direction of rotation and the operating force in the distal end and proximal end directions, which are transmitted from the inner tube 86 , can be transferred smoothly beyond the bending portion 34 to the distal end side (gripper 12 ). [0166] Furthermore, in accordance with the operating forces in the distal end and proximal end directions that are transmitted through the hollow tube 82 , the opening and closing operation of the gripper 12 can easily be carried out. Consequently, the treatment target X can easily be gripped by the gripper 12 , and a predetermined procedure (energizing treatment) can be performed efficiently on the treatment target X. The operating forces in the distal end and proximal end directions may be used not only for carrying out an opening and closing operation of the gripper 12 , but also for carrying out, for example, an operation for moving, in the distal end and proximal end directions, the end effector as it is. [0167] Still further, by rotating the hollow tube 82 in a position overlapping with the bending portion 34 , and thereby rotating the gripper retaining member 30 that is connected to the hollow tube 82 relatively with respect to the outer shell member 32 , the gripper 12 that is held by the gripper retaining member 30 can be rotated suitably. At this time, the projection 120 of the gripper retaining member 30 is inserted rotatably in the groove 154 of the outer shell member 32 , whereby rotation of the gripper retaining member 30 is guided by the groove 154 . Thus, the gripper 12 can be rotated more smoothly, and the gripper 12 can be oriented in a desired posture. [0168] Further still, by arranging the first and second coils 290 , 292 , which are wound in different winding directions, in the interior (hollow portion 82 a ) of the hollow tube 82 , the strength of the hollow tube 82 can be increased. More specifically, the rotational operating forces that are transmitted from the inner tube 86 can be transferred smoothly to the gripper 12 through the hollow tube 82 , the strength of which is increased and the shape of which is maintained. [0169] Further, by means of the manipulator 10 according to the present embodiment, even if the hollow tube 82 , which is disposed in a position overlapping with the bending portion 34 , is subjected to bending by the bending portion 34 , the operating force from the inner tube 86 is transferred to the distal end side (the gripper retaining member 30 and the moving body 94 ) relative to the bending portion 34 , while the hollow tube 82 remains in a bent condition. Thus, at the distal end side with respect to the bending portion 34 , variations in posture or opening and closing operations of the gripper 12 can easily be performed. [0170] In this case, by disposing the conductive line 60 in the hollow portion 82 a of the hollow tube 82 , a conductive path leading to the gripper 12 , which is constituted as a bipolar type of electrosurgical knife, can easily be constructed, and electrical power can be supplied stably to the gripper 12 . [0171] For example, in the event that the operating force transmitted from the handle 18 is an operating force for rotating the inner tube 86 , the hollow tube 82 is rotated by the operating force, and the gripper 12 , which is connected to the distal end side of the hollow tube 82 , is made to undergo a rolling operation, whereby the gripper 12 can be made to face toward the treatment target X at a desired posture. At this time, by integral rotation of the conductive line 60 that is accommodated in the hollow tube 82 , disconnection between the gripper 12 and the conductive line 60 (conductive path) can reliably be prevented. [0172] Further, as described above, the slip ring system 270 is provided in the manipulator 10 . Specifically, a structure is enabled in which the contact terminals 64 are electrically connected to the cylindrical terminals 62 during times that the cylindrical terminals 62 are rotating and at rest. Consequently, even if the inner tube 86 is rotated in order for the gripper 12 to undergo the rolling operation, conduction of electricity with the high frequency power source 22 can continuously be maintained. Accordingly, even if the posture of the gripper 12 in the direction of rotation is changed, an electrical treatment can suitably be carried out. [0173] Further, for example, in the event that the operating force transmitted from the handle 18 is an operating force for moving the inner tube 86 in the distal end and proximal end directions, the hollow tube 82 is advanced and retracted together with movement of the inner tube 86 , whereby the gripper 12 can be opened and closed. At this time, by integral advancing and retracting movement of the conductive line 60 integrally with the hollow tube 82 , disconnection between the gripper 12 and the conductive line 60 (conductive path) can reliably be prevented. [0174] Furthermore, by means of the manipulator 10 according to the present embodiment, by constructing the bending portion 34 from the plural (five) joint members 36 , the hinge members 38 , and the first and second belts 66 , 68 , the gripper 12 can easily be bent in a direction that differs from the axis Os of the shaft 16 . Further, through application of the first and second belts 66 , 68 , the alignment of the plural joint members 36 can stably be maintained. For example, an operation to restore the bending portion 34 to its origin (where the bending portion 34 is aligned with the axial direction of the shaft 16 ) or the like can be performed quickly and accurately. Furthermore, in the case that the first and second belts 66 , 68 cause the bending portion 34 to bend, the plural joint members 36 can smoothly be bent together in conjunction. The belts are not limited to the structure described above in which a pair (two) of such belts are disposed on the bending portion 34 , and one or three or more of such belts may be provided. [0175] In the case that a pair of belts (the first and second belts 66 , 68 ) are provided, by relative operations of the first and second belts 66 , 68 , the bending portion 34 can be bent smoothly. In other words, by carrying out an operation to move the first belt 66 in the proximal end direction and to move the second belt 68 oppositely in the distal end direction, the gripper 12 can easily be tilted to the side of the first belt 66 . [0176] Further, by providing the pinion 80 and the first and second slide members 74 , 76 in the handle 18 , the rotational driving force of the pinion 80 can easily be converted into operating forces in the distal end and proximal end directions of the first and second slide members 74 , 76 . In addition, the operating forces can be transmitted easily to the first and second belts 66 , 68 through the first and second semicircular pipes 70 , 72 . In this case, by controlling the rotational amount of the pinion 80 , the amount by which the bending portion 34 curves (i.e., the tilt angle of the gripper 12 ) can be changed freely. [0177] Furthermore, in the manipulator 10 , by the first and second belts 66 , 68 being guided by the guide members 283 , the first and second belts 66 , 68 move smoothly with respect to the center tubular portion 162 , and the operating force that moves the first and second belts 66 , 68 in the distal end and proximal end directions can easily be transferred to the surrounding joint members 36 . At the time that the bending portion 34 is bent, outward bulging of the first and second belts 66 , 68 can be suppressed. Furthermore, by disposing the guide members 283 on the outer side of the hollow parts 162 a , various transmission members that serve to operate the end effector (gripper 12 ) can appropriately be arranged in the hollow parts 162 a. [0178] Further, the guide members 283 are equipped with the projecting walls 284 that function as separations between the hollow parts 162 a and the belt spaces 286 . Thus, since flexure of the first and second belts 66 , 68 toward the inside (toward the centers of the joint members 36 ) is restricted by the projecting walls 284 at the time that the bending portion 34 is bent, the bending portion 34 can be bent more smoothly. [0179] Furthermore, by forming the arcuate surfaces 288 that are capable of contacting the hollow tube 82 on the inner side surface of the center tubular portions 162 , in the case that the bending portion 34 is bent, the hollow tube 82 that is inserted through the interior of the center tubular portions 162 can also easily be bent. [0180] Still further, with the manipulator 10 according to the present embodiment, by providing the rotation mechanism 88 and the advancing and retracting movement mechanism 98 in the interior of the handle 18 , the inner tube 86 can be moved in the distal end and proximal end directions, and the inner tube 86 can be rotated. Two types of operating forces of the inner tube 86 are transmitted to the gripper 12 of the distal end working unit 14 that is disposed on the distal end of the shaft 16 , whereby variations in posture and opening and closing operations of the gripper 12 can be carried out easily. [0181] In this case, by forming the length in the axial direction of at least one of the rotary driven gear 226 and the rotary main drive gear 230 of the rotation mechanism 88 to be longer than the movement amount of the inner tube 86 performed by the advancing and retracting movement mechanism 98 , even if the inner tube 86 is moved in the distal end and proximal end directions by the advancing and retracting movement mechanism 98 , the rotary driven gear 226 and the rotary main drive gear 230 can be kept in meshing engagement with each other at all times. Thus, the inner tube 86 can be rotated in a stable fashion. [0182] Further, by disposing the rotating handle 50 at a position in the vicinity of the handle 18 , in a state in which the user of the manipulator 10 has gripped the handle 18 , the user can easily manipulate the rotating handle 50 , which is in such a nearby position. Further, by forming the rotating handle 50 to be narrower than the width of the handle 18 , in the case that multiple medical devices (a forceps, a manipulator 10 , etc.) are used during a procedure, interference of the rotating handle 50 with such medical devices can be reduced. [0183] Furthermore, by providing the latch gear 294 that rotates accompanying rotation of the rotating handle 50 and the latch piece 300 that abuts elastically against the latch gear 294 , when the rotating handle 50 is operated, a latching sensation can be imparted to the user. Consequently, the user can recognize intuitively the amount of rotation of the rotating handle 50 , and can easily adjust the rotation of the inner tube 86 . [0184] Still further, in the advancing and retracting movement mechanism 98 , based on rotational operations of the responsive member 246 , the projecting portion 248 is displaced in the distal end and proximal end directions, and the sliding drive shaft 228 including the recessed portion 244 in which the projecting portion 248 is inserted also is displaced in the distal end and proximal end directions. Accordingly, the inner tube 86 on which the sliding drive shaft 228 is installed can move smoothly in the distal end and proximal end directions. Further, since the recessed portion 244 is formed in the circumferential direction, the sliding drive shaft 228 can rotate relatively with respect to the projecting portion 248 , and with a simple structure, rotation of the inner tube 86 can be allowed. [0185] More specifically, with the manipulator 10 according to the present embodiment, high operability of the gripper 12 that is inserted in the interior of the living body can be obtained, and the procedure performed on the treatment target X can be conducted efficiently and accurately. [0186] Although a certain preferred embodiment of the present invention has been shown and described in detail above, it should be understood that the present invention is not limited to the above embodiment and various changes and modifications may be made to the embodiment without departing from the scope of the invention as set forth in the appended claims. For example, in the above-described manipulator 10 , a structure is provided in which only the yawing operation is made to operate electrically (through the drive motor 46 ). However, the invention is not limited to this feature. More specifically, in the manipulator 10 , among the yawing operation, the rolling operation, and the opening and closing operation, any one or two or more of these operations can be constituted as an electrically driven operation, or alternatively the yawing operation, the rolling operation, and the opening and closing operation can all be constituted as manually driven operations.

1a

BACKGROUND OF THE INVENTION This invention relates, in general, to baby chairs, and, in particular, to a device for bouncing baby chairs. DESCRIPTION OF THE PRIOR ART In the prior art various types of devices for bouncing baby chairs have been proposed. For example, U.S. Pat. No. 6,574,806 to Maher discloses a device for rocking a chair comprising a crank arm and a strap member that extends from the crank arm to the top of the chair. As the crank rotates the strap pulls on the chair to rock it. U.S. Pat. No. 3,186,008 to Fuller discloses a device for rocking a chair comprising a cam that rotates within a slot in a chair base. The base is positioned on an incline so the base will move up and down as the cam rotates. U.S. Pat. No. 5,342,113 to Wu discloses a device for rocking a chair comprising a rotary arm driven by a motor and a shaft is connected to the arm at one end and to the chair at the other end so as the arm rotates the shaft pulls on the chair to rock it. U.S. Pat. No. 3,653,080 to Hafele discloses a device for rocking a chair comprising a rotary arm driven by a motor and a shaft is connected to the arm at one end and to the chair at the other end so as the arm rotates the shaft pulls on the chair to rock it. U.S. Pat. No. 6,774,589 to Sato et al discloses a device for rocking a chair comprising a solenoid for bi-directionally attracting a magnetic member on the chair. U.S. Pat. No. 4,985,949 to Jantz discloses a device for rocking a chair comprising a drive means consisting of an eccentric mounted to the output of a drive unit and slidably connected to a lifting member which converts rotational energy of the drive unit to vertically reciprocating motion of the lifting member. U.S. Pat. No. 3,851,343 to Kinslow, Jr. discloses for rocking a chair comprising a rotary arm driven by a motor and a shaft is connected to the arm at one end and to the chair at the other end so as the arm rotates the shaft pulls on the chair to rock it. U.S. Pat. No. 5,615,428 to Li discloses a device for rocking a chair comprising an elastic cord attached at one end to the chair and attached to a pivoting arm at the other end, and the arm is rotated by a motor. U.S. Pat. No. 5,464,381 to Wilson discloses a device for rocking a chair comprising a motor with an eccentric which provides motion for the seat. U.S. Pat. No. 5,660,597 to Fox et al discloses a device for rocking a chair comprising a unit that attaches to the chair and provides a vibrating motion. U.S. Pat. No. 4,141,095 to Adachi discloses a device for rocking a chair comprising a chair pivoted at one end to a U-shaped stand and a rocking mechanism for moving the chair about the pivot. U.S. Pat. No. 3,806,966 to Thompson discloses a device for rocking a cot comprising a wheel which is driven by a motor and the wheel has a pin which engages a slot on the cot, so the revolving pin moves the cot up and down as it rotates. SUMMARY OF THE INVENTION The present invention is directed to a device for bouncing a baby chair. The device has a seat into which a baby can be placed. The seat is attached to a stand that provides a springy action to the baby seat. The stand has an adjustment mechanism so the stand can be adjusted to compensate for babies of different weights. It is an object of the present invention to provide a new and improved baby chair. It is an object of the present invention to provide a new and improved baby chair that can compensate for different size babies. It is an object of the present invention to provide a new and improved baby chair that is easily adjustable for different size babie These and other objects and advantages of the present invention will be fully apparent from the following description, when taken in connection with the annexed drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of the present invention. FIG. 2 is a side view of a drive mechanism in one position of the present invention. FIG. 3 is a side view of the drive mechanism of FIG. 2 in another position. FIG. 4 is a side view of another drive of the present invention. FIG. 5 is a side view of the drive mechanism of FIG. 4 in another position. FIG. 6 shows a perspective view of the present invention with a different locking mechanism. FIG. 7 shows a partial view of the locking mechanism of FIG. 6 . DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings in greater detail, FIG. 1 shows a baby seat or chair having a back rest 1 which is attached to a seat portion 2 which in turn is attached to a support portion 3 . It should be noted that the seat shown in FIG. 1 is merely illustrative of a baby seat, and other shapes could be used without departing from the scope of the present invention. The support portion 3 has a horizontal portion 4 which is secured, in any conventional manner, to a support block 10 , most of which has been removed from FIG. 1 for clarity. The support block 10 receives and supports the horizontal portion 4 in any conventional manner. The chair has a second horizontal portion 13 which fits into the support block 10 , but is free to move with respect to the block. The top of the second horizontal portion 13 has a series of valleys 9 which form teeth 14 in between the valleys. In addition, the end of the second horizontal portion 13 has a stop 8 so the gear 6 can not move off the second horizontal portion 13 . The chair has a second support portion 11 and a third horizontal portion 12 which form the rest of the support for the chair. A control knob 5 is mounted for rotation to the block 10 in any conventional manner. The knob 5 is connected to gear 6 so that when knob 5 is rotated, gear 6 will also rotate. Gear 6 engages the teeth 14 on the top of the second horizontal portion 13 so when knob 5 is turned in one direction the first horizontal portion 4 moves toward the right in FIG. 1 . When knob 5 is turned in the opposite direction the first horizontal portion 4 moves toward the left in FIG. 1 . The portions 11 , 12 , 13 of the support stand are made from a springy material so the upper leg 13 will move up and down with respect to the lower leg 12 . The adjustment mechanisms 5 , 6 , 9 and 14 are designed to compensate for different size babies. As shown in FIG. 1 , the seat is adjusted to hold about a twenty pound baby. If the baby weighs more than twenty pounds, the adjustment mechanisms would be used to move the blocks 10 to the right in FIG. 1 . Since the top leg 13 is essentially a cantilevered beam, this would reduce the moment arm of the beam making it more difficult for the leg 13 to move up and down. If the baby weighs less than twenty pounds, the adjustment mechanisms would be used to move the blocks 10 to the left in FIG. 1 . Since the top leg 13 is essentially a cantilevered beam, this would increase the moment arm of the beam making it less difficult for the leg 13 to move up and down. Therefore, the adjustment mechanisms allow the present invention to be adjusted for virtually any size baby. In order to move the upper leg 13 (and the seat secured to leg 13 ) up and down, a motor driven mechanism is attached to the back portion 1 of the seat by any conventional attachment means 26 . A motor 27 is provided with a first wheel 26 that will be driven by the motor. The wheel 26 engages a second wheel 15 which rotates about a pivot point 25 , so the wheel 27 , driven by the motor 13 , will cause wheel 15 to rotate. Wheel 15 has a weight 16 attached thereto by any conventional means. The weight 16 will throw the wheel 15 out of balance as it rotates, which will cause a vibration in attachment means 26 , through seat 1 , 2 , 3 , through block 10 , and eventually into arm 13 . Since the arm 13 is springy, the seat 1 , 2 , 3 will move up and down and, in so doing, will entertain a baby seated in the seat. It should be noted that a framework will support motor 27 , and wheels 26 , 15 , however it has been removed from FIG. 1 for clarity. Also, any motor can be used in the present invention including, but not limited to, an AC motor, a DC motor, a battery operated motor, or a motor operated by a mechanical means such as a spring. FIGS. 2 and 3 show a different operating means for the seat of FIG. 1 . Wheel 15 ′ (which is essentially wheel 15 in FIG. 1 without weight 16 ) has a cam 17 secured thereto which moves a follower 18 as the wheel 15 ′ rotates. The wheel 15 ′ is rotated by a motor (not shown in FIGS. 2 , 3 ) like the motor 15 in FIG. 1 . The follower 18 is connected to a beam 19 , by any conventional means, which is pivoted at 23 on one end, and which has a weight 20 at the other end. As the cam 17 rotates from a down position, as shown in FIG. 2 ) to an up position (shown in FIG. 3 ) it moves the follower 18 which in turn pivots the beam 19 up. As the follower moves to the down position, the weight causes the beam 19 to move from the position shown in FIG. 3 to the position shown in FIG. 2 , thereby causing the wheel 15 ′ to vibrate which will vibrate the seat 1 , 2 , 3 . FIGS. 4 and 5 show a different activation mechanism. Wheel 15 ″ (which is essentially wheel 15 in FIG. 1 without weight 16 ) has a solenoid 21 secured thereto by any conventional means. The solenoid 21 can be operated by the same motor 13 or it can be operated by a separate motor. The solenoid 21 moves a shaft 22 up ( FIG. 5 ) and down ( FIG. 4 ) as the solenoid 21 is turned on and off. The shaft 22 is secured to the wheel 15 ″ in a way so the wheel will move up and down with the shaft 22 . In this way the wheel will vibrate which will cause the seat 1 , 2 , 3 to vibrate as in FIGS. 1 , 2 , 3 . Once the wheel, which is essentially just a weight, is started up and down by the solenoid it will continue in an up and down motion for a while even after the solenoid is turned off. FIGS. 6 and 7 show a different securing means for adjustably attaching the seat 1 ′″ to the springy legs 13 ′″ which are supported on legs 12 ′″ in the same manner as legs 13 and 12 in FIG. 1 . A bar 24 is secured, in any conventional manner, to the seat. The bar 24 has apertures that receive the legs 13 ′″. A set screw 23 is threaded into the bars 24 . In order to adjust the seat for different size babies, the set screw 23 will be loosened, the bar 24 will be moved to a new location, and then the set screw will be tightened to secure the bar in the new location. In all other respects, the device will operate in the same manner as the FIG. 1 device. It should be noted that the motor and wheels have been removed from FIGS. 6 and 7 for clarity. Although the Baby Bouncer and the method of using the same according to the present invention has been described in the foregoing specification with considerable details, it is to be understood that modifications may be made to the invention which do not exceed the scope of the appended claims and modified forms of the present invention done by others skilled in the art to which the invention pertains will be considered infringements of this invention when those modified forms fall within the claimed scope of this invention.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application claims priority from European Patent Application No. 11007282.4 filed Sep. 7, 2011, the disclosure of which is hereby incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present disclosure relates to a surgical power tool with a head portion having a tool and a shaft which is connected to the head portion for guiding the head portion to a surgical site. [0003] Surgical procedures often involve drilling, screwing or other operations at a bone. Surgical power tools are known in the art which support the surgeon when such operations need to be performed. [0004] A surgical power tool is, for example, disclosed in EP 836 976 A1 (U.S. Patent Application Publication No. US 2007/0225720). The power tool comprises a drill or similar tool arranged at a distal end of the power tool and a gripping shaft to handle the power tool. The longitudinal axis of the gripping shaft is angled with respect to the drill or other tool. [0005] When the surgeon accomplishes a surgical procedure, he or she has to exert pressure over the gripping shaft of the surgical power tool, so that enough force will arrive at the distally arranged tool. This situation could result in a slip of, for example, the drill at the surgical site, and the patient being treated can get injured. Consequently, it requires a great effort for the surgeon to carry out an accurate drill or cut with a surgical power tool without injuring the patient. BRIEF SUMMARY OF THE INVENTION [0006] There is a need for a surgical power tool which supports the surgeon to carry out an accurate operation at the surgical site and reduces the risk of injuring the patient. [0007] A surgical tool is provided that comprises a head portion having a tool with a tool axis and a shaft which is connected to the head portion for guiding the head portion to a surgical site, wherein the shaft has a longitudinal axis and the tool axis is angled with respect to the longitudinal axis of the shaft. The surgical power tool further comprises a handle portion for exerting pressure to the head portion along the tool axis. [0008] The axis of the tool is angled with respect to the shaft of the surgical power tool. This angle may be defined such that the user can easily reach the desired position at the surgical site. Thus, the angle can be between 60 and 120 degrees, for example between 80 and 100 degrees (e.g., approximately 90 degrees). The angle may be adjustable (e.g., mechanically or electrically). [0009] The power tool can be powered by any kind of electric motor. The electric motor can be accommodated in the shaft or the handle portion or can be connected to the surgical power tool by means of a driveshaft. The transfer of the power to the angled tool can be accomplished by any kind of transmission. The power tool can also be powered by pressurized air or in any other manner. [0010] The handle portion may comprise at its proximal end a handle for being gripped by a surgeon. The longitudinal axis of the handle may be substantially parallel with the tool axis. There can be any tolerance (e.g., up to 20 degrees) between the longitudinal axis of the handle and the tool axis. Due to the arrangement of the handle and the tool, pressure can be exerted to the head portion, in particular in the direction of the tool axis. The longitudinal axis of the handle may in particular be coaxial with the tool axis, so that the pressure can be accurately exerted in the direction of the tool axis and therewith to the surgical site. [0011] In an optional aspect, the handle of the handle portion is angled with respect to the shaft, so that pressure can be exerted in a direction toward the tool axis. The resultant force exerted by the surgeon on the handle may be directed towards the tool axis to support the surgical procedure. The angle between the handle and the shaft can be between 60 and 120 degrees, for example between 80 and 100 degrees (e.g., approximately 90 degrees). [0012] According to a further optional aspect, the handle portion is configured to secure the handle portion to the shaft, so that the handle portion is fixed and cannot be moved or rotated with respect to the shaft. This securing can be accomplished in a releasable manner, for example by a clamping element. The clamping element may be arranged at a distal end of the handle portion and can at least partly encompass the shaft. The clamping element can have a C- or U-like shape to accommodate the shaft. Any other shape is feasible as long as the connection can be fixed. [0013] In an exemplary implementation, the connection is such that the handle portion can easily be removed from the shaft (e.g., so that both parts can be individually sterilized). The handle portion can be secured to the shaft by means of a connecting fastener which can be a locking screw, snap-in connection or interlocking connection. [0014] Advantageously, the clamping element is distanced from the head portion, so that the handle portion is not directly connected to the head portion of the surgical power tool. The clamping element may be connected to the shaft close to the head portion to provide a small lever arm defined between the clamping element and the tool along the shaft. [0015] The clamping element may further be designed such that the handle portion can be adjusted relative to the longitudinal axis of the shaft, for example by a guided rail. The clamping element can also comprise some kind of electric contacts, so that information can be transferred from the handle portion to the shaft or the head portion. [0016] According to another optional aspect, the surgical power tool comprises an illumination device for providing light to the surgical site. The light may be guided by an optical cable to the surgical site or a light source can be arranged directly at the head portion. The light may be cool light. [0017] The illumination device can be guided along or inside the handle portion. In particular, the handle portion may be adapted to accommodate at least one part of the illumination device, for example a power supply of the light source, a switch of the light source and/or the light source itself. The illumination device can also be guided along or inside the shaft. [0018] In one realization, the surgical power tool comprises at least one of a mirror and an endoscope which provides a view of the surgical site, in particular the portion of the site illuminated by a illumination device. The mirror or endoscope can be arranged at the head portion, but it can also be arranged at the shaft or the handle portion. [0019] The mirror or endoscope or at least one part of it may be releasably connected to the surgical power tool. The mirror or endoscope may be adjusted, mechanically or electrically, by for example an electric motor. The adjustment may be provided remotely from the shaft or the handle portion. [0020] According to a further optional aspect, the surgical power tool comprises a rinsing device for providing fluid to the surgical site. The rinsing device can be guided at or inside the shaft or handle portion towards the tool. Any system which can provide a constant stream or flash of fluid can be connected to a rinsing inlet of the rinsing device. [0021] In a further realization, a fixture device may be arranged at the head portion, the shaft or the handle portion to hold any parts which are needed to carry out the surgical procedure. In particular, the fixture device may provide a clamping arrangement to hold the needed parts. These parts can comprise a tissue protection sleeve, a fixation module or plate that is be secured to the bone. BRIEF DESCRIPTION OF THE DRAWINGS [0022] These and other features, aspects and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein: [0023] FIG. 1 shows an embodiment of a surgical power tool in a perspective view; [0024] FIG. 2 is an enlarged perspective view of the surgical power tool showing FIG. 1 ; [0025] FIG. 3 is a further enlarged perspective view of the surgical power tool showing FIG. 1 ; [0026] FIG. 4 is a perspective view of a further embodiment of a surgical power tool; [0027] FIG. 5 is an enlarged perspective view of the embodiment shown in FIG. 4 ; and [0028] FIG. 6 is a further enlarged perspective view of the embodiment shown in FIG. 4 DETAILED DESCRIPTION [0029] Referring to FIG. 1 , there is shown an embodiment of a surgical power tool 1 in the form of a surgical power drill. As shown, the surgical power tool 1 comprises a shaft 10 which is surrounded at its proximal end by a grip 11 . The grip 11 extends over approximately at least half of the length of the whole shaft 10 , so that a surgeon can easily handle the power tool 1 . A head portion 20 is arranged at the distal end of the shaft 10 . This head portion 20 carries a tool 21 in the form of a drill to create a bore in the bone at the surgical site. The shaft 10 can comprise components to operate and/or drive the tool 21 of the surgical power tool 1 . Moreover, the tool 21 may be removable from the head portion 20 . [0030] As illustrated in FIG. 1 , the tool 21 as a tool axis that is angled with respect to a longitudinal axis of the shaft 10 . In the present embodiment, the angle is 90 degrees and may be adjustable within a predefined range. The surgical power tool 1 further comprises a handle portion 30 having a handle 31 at its proximal end. The handle 31 is long enough so that at least one hand of the surgeon can easily grasp the handle 31 . A longitudinal axis of the handle 31 is parallel to the tool axis of the tool 21 and may be coaxial therewith. [0031] The handle portion 30 further comprises a connecting shaft portion or linkage 33 and a clamping element 32 at its distal end. The linkage 33 is arranged between the handle 31 and the clamping element 32 . The linkage 33 is formed in a bent shape and is rigid, so that application forces can be transferred. Specifically, the linkage 33 has the form of approximately an S to facilitate, for example, intra-oral and/or transbuccal procedures. The linkage 33 is located in a plane defined by a longitudinal axis of the shaft 10 and the longitudinal axis of the handle 31 . [0032] The clamping element 32 is arranged at the distal end of the handle portion 30 and is configured to secure the handle portion 30 to the shaft 10 . The location of the clamping element 32 is situated on the shaft 10 between the head portion 20 and the grip 11 . The clamping element 32 is located spaced apart but near the head portion 20 , so that pressure can be exerted to the tool 21 over the clamping element 32 without straddling the linkage 33 . [0033] As shown in FIG. 2 , the clamping element 32 partly encompasses the shaft 10 and is locked by a connecting fastener 34 . The shaft 10 is fixedly clamped by the clamping element 32 , so that no movement or rotation of the handle portion 30 relative to the shaft 10 is possible. The connecting fastener 34 is a locking screw which is configured to push one part of the clamping element 32 towards the shaft 10 and therewith provides a frictional engagement. Thus, handle 30 and the shaft 10 are releasably fixed to each other. [0034] A head of the locking screw 34 is large enough so that the surgeon can easily secure and release the locking screw 34 . Due to the straight shape of the shaft 10 , the clamping element can be axially moved along the shaft 10 to any desired position when the locking screw 34 is released. The handle 31 can also be removed from the shaft 10 for cleaning and sterilization activities. [0035] As illustrated in FIGS. 2 and 3 , an illumination device 40 comprising a light inlet 41 , an optical cable 43 and a light outlet 42 is (mainly) arranged along the linkage 33 of the handle portion 30 . The light inlet 41 comprises a connector (not shown) to receive a light unit which generates a beam of cool light. The light outlet 42 is directed toward the tool 21 to illuminate the surgical site, wherein the light outlet 42 can be movable to position the light outlet 42 such that the surgeon is not bothered. [0036] The surgical power tool 1 further comprises a rinsing device 50 having a rinsing inlet 51 , a tube 52 and a rinsing outlet 53 . The rinsing inlet 51 is configured to be coupled to any device capable of providing a rinsing fluid. The tube 52 leads the fluid from the rinsing inlet 51 to the rinsing outlet 53 . The rinsing outlet 53 can be selectively positioned by the surgeon such that the fluid is directed towards the surgical site. The rinsing device 50 is guided along and connected to the part of the shaft 10 which is not encompassed by the grip 11 . [0037] A mirror 60 is arranged at the head portion 20 opposite of the shaft 10 , so that the surgeon operating the surgical power tool 1 can view the surgical site through this mirror 60 . The mirror 60 can be adjusted as needed by the surgeon. In addition or as an alternative to the mirror 60 , an endoscope may be used to provide a view of the surgical site. The endoscope may be attached to the surgical power tool 1 in a similar manner as (e.g., instead of) the illumination device 40 and the rinsing device 50 . [0038] FIGS. 4 to 6 show a further embodiment of a surgical power tool 1 . The difference between this embodiment and the aforementioned embodiment is that the illumination device 40 is now arranged at the shaft 10 next to the rinsing device 50 . All other parts and features correspond to the aforementioned embodiment. [0039] As has become apparent from the embodiments, the shaft for guiding the head portion to the surgical site and the handle portion to exert pressure to the tool are separated from each other, so that the surgeon can accurately guide the head portion to the desired position with one hand on grip 11 and can further exert pressure to the handle portion with the other hand on handle 31 . [0040] The surgical power tool described in the above embodiments has a tool in the form of a drill. It will be appreciated that the tool could alternatively be realized by a screw driver blade or in any other manner. [0041] While the present disclosure has been described with respect to particular embodiments, those skilled in the art will recognize that the present invention is not limited to the specific embodiments described and illustrated herein. It is to be understood that the disclosure is only illustrative. Accordingly, it is intended that the invention be limited only by the scope of the claims attended hereto.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority of German application No. 10 2010 062 030.0 filed Nov. 26, 2010, which is incorporated by reference herein in its entirety. FIELD OF THE INVENTION [0002] The invention relates to a method for calculating perfusion data, such as blood volume or blood flow for example, from 2-D angiography data or DSA sequences. BACKGROUND OF THE INVENTION [0003] The blood supply can be compromised inter alia by stenoses in blood vessels. These can either be treated through medication or by means of an angioplasty—with or without stent—or alternatively be circumvented by means of a bypass, of coronaries for example. [0004] The success of these treatments is usually demonstrated by the diameter of the vessel both before and after a treatment or determined according to the subjectively optical distribution of the contrast agent in an image of the vessel acquired for example by means of DSA (Digital Subtraction Angiography). However, the treatment with medication in particular has no effect on the vessel diameter. In the case of perfusion deficits caused by spasms it is nonetheless in fact true that the administration of drugs (e.g. nimodipine) leads to a dilation of the vessel. [0005] A typical X-ray system by means of which DSA sequences of the aforesaid type can be produced is shown for example in FIG. 1 , which depicts a monoplane X-ray system having a C-arm 2 which is mounted on a pedestal 1 in the form of a six-axis industrial or articulated-arm robot and at the ends of which are attached an X-ray radiation source, for example an X-ray emitter 3 comprising X-ray tube and collimator, and an X-ray image detector 4 as image acquisition unit. [0006] The C-arm 2 can be adjusted arbitrarily in space by means of the articulated-arm robot known for example from U.S. Pat. No. 7,500,784 B2, which robot preferably has six axes of rotation and therefore six degrees of freedom, for example in that it is rotated about a center of rotation between the X-ray emitter 3 and the X-ray image detector 4 . The angiographic X-ray system 1 to 4 according to the invention is rotatable in particular about centers of rotation and axes of rotation in the C-arm plane of the X-ray image detector 4 , preferably about the center point of the X-ray image detector 4 and about axes of rotation intersecting the center point of the X-ray image detector 4 . [0007] The known articulated-arm robot has a base frame which is permanently installed on a floor for example. Attached thereto is a carousel which is rotatable about a first axis of rotation. Mounted on the carousel so as to be pivotable about a second axis of rotation is a robot rocker arm to which is attached a robot arm which is rotatable about a third axis of rotation. Mounted at the end of the robot arm is a robot hand which is rotatable about a fourth axis of rotation. The robot hand has a retaining element for the C-arm 2 , said retaining element being pivotable about a fifth axis of rotation and rotatable about a sixth axis of rotation running perpendicular thereto. [0008] The X-ray diagnostic apparatus is not dependent for its implementation on the industrial robot. Conventional C-arm devices having a standard ceiling- or floor-mounted retaining fixture for the C-arm 2 can also be used. Instead of the C-arm 2 shown by way of example, the angiographic X-ray system can also have separate ceiling- and/or floor-mounted retaining fixtures for the X-ray emitter 3 and the X-ray image detector 4 which are rigidly coupled electronically, for example. [0009] The X-ray image detector 4 can be a rectangular or square, flat semiconductor detector which is preferably produced from amorphous silicon (a-Si). Integrating and possibly counting CMOS detectors can also be used, however. [0010] A patient 6 that is to be examined is located as the examination subject in the beam path of the X-ray emitter 3 on a tabletop 5 of a patient positioning table. Connected to the X-ray diagnostic apparatus is a system control unit 7 having an imaging system 8 which receives and processes the image signals from the X-ray image detector 4 (control elements are not shown, for example). The X-ray images can then be studied on displays of a traffic-light monitor array 9 . [0011] Numerous diagnostic and therapeutic applications require information in relation to tissue perfusion. What is understood by this general term is quantitative information in respect of the blood flow through tissue regions such as, for example, tumors in the oncology environment or infarction-threatened cerebral areas in the neurology domain. Key perfusion parameters include the blood volume (static, typically specified in ml/100 g) and the blood flow (dynamic, typically specified in ml/100 g/min). [0012] Perfusion measurements are established methods in computed tomography (CT), in magnetic resonance tomography (MRT) and in nuclear medicine. Ultrasound technology also permits conclusions in relation to perfusions to be reached to a limited degree. [0013] To date, however, there still exists no practical prior art approach to extracting perfusion data such as blood volume and blood flow from 2-D angiography data or DSA sequences. [0014] Theoretical preliminary work is described in “Estimating perfusion using X-ray angiography” by Hrvoje Bogunovic and Sven Loncaric, Proc. IEEE ISPA, 2005, pages 147 to 150. However, this approach as described in Bogunovic et al. has the disadvantage that the perfusion measurements are dependent on the injection profile of the contrast agent bolus. Moreover the approach according to Bogunovic et al. yields only qualitative results, since proportionality constants are ignored. [0015] In computed tomography, which constitutes an imaging method in 3-D, there exist various physical models and approaches which serve as a basis for the calculation of CT perfusion data and some of these are also already available as products. These models serve as a starting point for present approaches based on 2-D image series. SUMMARY OF THE INVENTION [0016] The invention is based on the object of embodying a method of the type cited in the introduction in such a way that relative perfusion data in respect of blood volume and blood flow can be extracted in a simple manner from 2-D angiography data or from 2-D DSA sequences. [0017] The object is achieved according to the invention by the features disclosed in the independent claim. Advantageous embodiments are set forth in the dependent claims. [0018] The object is achieved according to the invention by means of the following steps: S1) recording at least one angiography scene using specific acquisition parameters in order to generate the 2-D angiography data or DSA sequences with administration of contrast agent based on a multiplicity of individual angiography images, S2) defining a region of interest suitable for comparison purposes, S3) calculating the volume segments defined by the region of interest, S4) determining the time/contrast curve in the volume segments, S5) ascertaining perfusion data for the purpose of calculating the relative perfusion data, S6) comparing the perfusion data, S7) calculating the relative perfusion data, and S8) rendering the calculated relative perfusion data. [0027] The invention therefore relates to a method for determining relative perfusion data such as blood volume and blood flow for example. The term “relative” refers to the fact that the perfusion data (blood volume and blood flow) calculated by means of the method steps according to the invention is not specified in terms of absolute physical quantities, but is provided simply as ratios (left/right or before/after (pre-/post-treatment)). [0028] By defining a region of interest suitable for comparison purposes it is possible to arrive at conclusions about the mass ratio of the contrast agent associated with respective time instants (and hence of the blood, provided an ideal mixture of blood and contrast agent is assumed) within the volume segments defined by the region of interest, such that the relative blood volume and/or the relative blood flow can be calculated. [0029] However, if absolute perfusion data, for example from previous CT perfusion examinations (CTP examinations), is available, then approximations for absolute perfusion data can again be derived from the relative perfusion data. [0030] It has proven advantageous if an angulation of the angiography system is chosen which has the fewest possible interfering overlays of the tissue region that is to be examined by blood vessels lying spatially in front of or behind said tissue region. The greater the number of such overlays occurring, the more inaccurate will be the estimation of the relative perfusion parameters. [0031] According to the invention the perfusion data according to step S5) can be the blood volume and/or the blood flow. [0032] The comparison according to step S6) can advantageously be carried out at two time instants in the before/after comparison and/or at two locations in the left/right comparison. [0033] It has proven advantageous, for the purpose of the comparison according to step S6), to form the ratio of slopes, intensities, areas at a specific time instant and/or of the maxima of the intensities of the time/contrast curves. [0034] According to the invention changes to exposure parameters due to regulating actions of a system control unit can be calculated out of the image sequences by means of an imaging system. Said changes to exposure parameters can result for example from an automatic dose regulation by the angiography system. [0035] During the definition of a region of interest (ROI) according to step S2) for the purpose of a before/after comparison at the respective time instant, the acquisition parameters can advantageously be kept constant, for example in the case of tumor embolizations, wherein according to the invention the acquisition parameters that are kept constant can be the angulation of the C-arm, the zoom factor used and the injection protocol. [0036] During the definition of a region of interest according to step S2) for the purpose of left/right comparisons it is possible according to the invention to choose an injection protocol which prefers no half of the body per se. Typically a stationary state is necessary for determining the blood volume in a tissue region. [0037] According to the invention the left/right comparison can be carried out in the brain or in paired organs, such as the kidneys for example. [0038] It has proven advantageous if, upon presentation of absolute perfusion data from previous CT perfusion examinations, approximations for absolute perfusion data are again derived from the relative perfusion data. BRIEF DESCRIPTION OF THE DRAWINGS [0039] The invention is explained in more detail below with reference to exemplary embodiments illustrated in the drawing, in which: [0040] FIG. 1 shows a known biplane C-arm X-ray system for neuroradiology, [0041] FIG. 2 shows a 3-D region which is implicitly defined by means of a chosen 2-D region of interest, [0042] FIG. 3 shows a first time/contrast curve before the treatment, [0043] FIG. 4 shows a second time/contrast curve after the treatment, [0044] FIG. 5 shows a first simplified time/contrast curve, [0045] FIG. 6 shows a second simplified time/contrast curve, [0046] FIG. 7 shows a first time/contrast curve before the treatment, [0047] FIG. 8 shows a second time/contrast curve after the treatment, [0048] FIG. 9 shows a simplified model of a first time/contrast curve, and [0049] FIG. 10 shows a simplified model of a second time/contrast curve. DETAILED DESCRIPTION OF THE INVENTION [0050] The following terms should first be clarified at the outset: [0051] Region of Interest (ROI): [0052] The invention is based on the appropriate definition of regions of interest (ROIs), as will be explained briefly with reference to FIG. 2 . In a 2-D X-ray or angiography image 11 containing blood vessels 12 for example, what is understood quite generally by an ROI is a user-defined section of the angiography image 11 . As a result of the preceding subtraction of the mask image in the case of DSA sequences the sum of the grayscale values of all pixels lying within the ROI in each individual image of the sequence is directly proportional to the mass of the contrast agent that is contained in the 3-D volume segment V ROI defined by the ROI. Since no depth information at all is in fact contained in a 2-D X-ray image 11 , present approaches consequently always acquire the 3-D volume segment V ROI which is “excised” by the ROI defined in 2-D and which extends over the entire object depth. [0053] It is important for the application of the approaches proposed here that an angulation of the angiography system is chosen which has the fewest possible overlays of the tissue region that is to be examined by blood vessels 12 lying spatially in front of or behind said tissue region. The greater the number of such overlays occurring, the more inaccurate will be the estimation of the relative perfusion parameters. [0054] Relative Blood Volume from 2-D Angiography Data: [0055] Defining suitable ROIs—either for the purpose of before/after comparisons (e.g. in the case of tumor embolizations) or for the purpose of left/right comparisons either in the brain or in paired organs such as the kidneys for example—enables results to be computed in relation to the mass ratio of the contrast agent associated with the respective time instant (in left/right comparisons) or with the respective two time instants (in before/after comparisons) (and hence of the blood, provided an ideal mixture of blood and contrast agent is assumed) within the volume segments V ROI defined by the ROIs. [0056] Meaningful determinations of the relative blood volume naturally demand here that in the case of before/after comparisons the acquisition parameters, such as in particular the angulation of the C-arm and the zoom factor used for example, and the injection protocol remain constant. Any changes to the exposure parameters resulting from the automatic dose regulation by the angiography system must be calculated out of the image sequences accordingly in order to allow a meaningful comparison. In the case of left/right comparisons it is of course likewise necessary to choose a suitable injection protocol which prefers no half of the body per se. Typically a stationary state is required for determining the blood volume in a tissue region. [0057] According to the theory (see equation (5) in Konstas et al.) the blood volume V in a volume segment can in fact also be calculated from dynamic data as follows: [0000] V ∝ ∫ 0 T  C tissue  ( t )   t ∫ 0 T  C artery  ( t )   t . ( 1 ) [0000] C tissue (t) denotes the average contrast agent concentration in the tissue region under examination, while C artery (t) denotes the sum of the average contrast agent concentrations in the supplying arteries. In this case the upper integration limit T should be suitably chosen to enable the transported contrast agent bolus to be recorded completely. However, the integration should only include the time in which the contrast agent bolus undertakes a first pass through the tissue so that distortions of the values caused by recirculation of the bolus are avoided. [0058] In before/after comparisons with constant injection protocol and constant acquisition parameters as well as in left/right comparisons with appropriately chosen injection protocol it may be assumed for simplicity that the arterial input left and right or, as the case may be, before and after is consistent, such that in the case of before/after comparisons the relation [0000] V after V before = ∫ 0 T  C tissue , after  ( t )   t ∫ 0 T  C tissue , before  ( t )   t ( 2  t ) [0000] is obtained and in the case of left/right comparisons the analog relation [0000] V left V right = ∫ 0 T  C tissue , left  ( t )   t ∫ 0 T  C tissue , right  ( t )   t ( 2  o ) [0000] is obtained. It should be noted that a change in the blood flow (specified in ml/100 g/min) in the case of before/after comparisons or a different blood flow left/right in the case of left/right comparisons has no relevance, since the flow has already been eliminated in the course of the derivation of equation (1). Equation (1) henceforth includes only the time-dependent contrast agent concentrations. [0059] Taking into account that the concentration of the contrast agent is proportional to the mass of the contrast agent (concentration=mass/volume), and assuming that the volume segments being examined are present with at least approximately the same size (both in before/after and in left/right comparisons), the proportionality constants (1/volume) are omitted in the above formulae and the corresponding relative blood volumes can be expressed by means of the contrast agent masses. As already mentioned further above, the contrast agent masses are in turn proportional to the sums of the grayscale values of all pixels lying within the ROIs (in each individual image of the sequence). [0060] Accordingly the relative blood volumes can be determined as follows: [0000] V after V before = ∫ 0 T  m after  ( t )   t ∫ 0 T  m before  ( t )   t ( 3  t ) [0000] and analogously thereto [0000] V left V right = ∫ 0 T  m left  ( t )   t ∫ 0 T  m right  ( t )   t . ( 3  o ) [0061] In the two previous formulae, therefore, the time integrals are placed over the ROI-specific time/contrast curves in the numerator and in the denominator in each case. [0062] The general case of the calculation of the change in relative blood volume is explained in more detail with reference to FIGS. 3 to 6 . For the purpose of determining relative perfusion data according to the invention a perfusion measurement device 10 is provided in the system control unit 7 , as shown in FIG. 1 . As output of the calculated perfusion data this also effects an insertion for example as a numeric value characteristic of the ROI into the image on a display of the traffic-light monitor array 9 . [0063] FIG. 3 shows a first time/contrast curve 13 I/t before the treatment and FIG. 4 shows a second time/contrast curve 14 I/t after the treatment. The area AUC (area under the curve) under the overall curves 13 and 14 is formed by the time integrals. Their ratio expresses a change in relative blood volume. In order to calculate the change in relative blood volume the areas under the overall curves 13 and 14 can now be put into the ratio AUC after /AUC before . [0064] For simplicity the calculation of the integrals according to the examples explained with reference to FIGS. 3 and 4 can be dispensed with here and in each case the maximum of the associated time/contrast curve can be used instead, as is shown with reference to FIGS. 5 and 6 (in this regard see also FIG. 2 in Konstas et al. “Theoretic Basis and Technical Implementations of CT Perfusion in Acute Ischemic Stroke, Part 1: Theoretic Basis”, AJNR Am. J. Neuroradiol. 30, 2009, pages 662 to 668). This simplification is based on the assumption that there are plateau-like maxima of the time/contrast curves at which a saturated state of the contrast agent concentration can be assumed. The advantage of this simplification consists in the fact that it is not necessary to integrate over a relatively long time period and therefore overlay effects caused by the contrast agent flow in draining veins, which could of course also be visible in the projection image, are avoided. However, this simplifying estimation of the relative blood volume requires a greater amount of contrast agent to be administered in order to achieve the stationary state, which is not always desirable or feasible. [0065] According to the invention the calculation can now be simplified in that, as shown in FIGS. 5 and 6 , the slopes 15 and the maxima 16 of the first simplified time/contrast curve before the treatment and the second simplified time/contrast curve after the treatment are assumed to be straight lines. The maximum intensity 17 I max,v before the treatment and the maximum intensity 18 I max,n after the treatment can then be ascertained in a simple manner. [0066] In order to calculate the simplified change in relative blood volume the two maximum intensities are now put into the ratio I max,after /I max,before . Example [0067] In the case of a tumor embolization the tumor can be characterized in the two DSA sequences (pre- and post-treatment (before/after)) by means of an ROI in each case and then the ratio of the time integrals over the two time/contrast curves determined. According to the above consideration their quotient represents the ratio of the blood volumes before and after the intervention. Ideally, no more contrast agent at all accumulates in the tumor after the embolization, thus yielding the ratio V after /V before ˜0 as result. As already mentioned, a suitable angulation must be chosen for an examination of said type to ensure that no large blood vessels run through the volume segment defined by means of the ROI, since these would distort the result. [0068] Relative Blood Flow from 2-D Angiography Data: [0069] The relative blood flow can be determined in a comparable way to the determining of the relative blood volume. In this case the so-called “maximum slope method” can be used, see equation (10) in Konstas et al. In spite of simplifying assumptions this method is also employed in CT for the purpose of measuring the blood flow. This method provides a simple computing rule for determining the flow F which is assumed as constant over time: [0000] [  m  ( t )  t ] max = F · [ C artery  ( t ) ] max [0070] Here, m(t) denotes the mass of contrast agent contained in the tissue volume under examination at the time instant t, and C artery (t) denotes the contrast agent concentration in the supplying artery at the time instant t. For the sake of simplicity it is assumed that no venous outflow takes place during the examination time period and that precisely one artery supplies the examined tissue volume. According to this relation the flow F can therefore be determined by dividing the maximum rise of the mass of contrast agent in the tissue by the maximum contrast agent concentration in the supplying artery. [0071] The general case of the calculation of the change in relative blood flow is explained in more detail with reference to FIGS. 7 and 8 . In this case FIG. 7 shows a first time/contrast curve 19 before the treatment. A first maximum slope 20 is applied to the ascending branch of said first time/contrast curve 19 . FIG. 8 shows a second time/contrast curve 21 after the treatment, to the ascending branch of which a second maximum slope 22 is applied. [0072] As also in the case of the determining of the relative blood volume from 2-D angiography data, suitable ROIs should be defined in 2-D at a suitable angulation of the C-arm, which ROIs then again characterize 3-D volume segments that extend over the entire object depth. On the assumption that the arterial inflow left/right or before/after is the same, the relative blood flow can be approximated as follows in the case of left/right comparisons according to the formula [0000] F left F right = [  m left  ( t )  t ] max [  m right  ( t )  t ] max ( 4  o ) [0000] and in the case of before/after comparisons according to the formula [0000] F after F before = [  m after  ( t )  t ] max [  m before  ( t )  t ] max . ( 4  t ) [0073] This means that—owing to the direct proportionality of contrast agent mass and the attenuation along the X-ray beams—the quotients from the maximum slopes 20 and 22 of the time/contrast curves 19 and 21 must be formed in order to obtain the corresponding estimations of the relative blood flow. [0074] Thus, as was already the case in the determining of the relative blood volumes, the “trick” consists in determining the relative flows (left/right and/or after/before), since then the proportionality constants, which are not known due to the absence of depth information, are omitted from the formation of the quotients. [0075] The simplified case of the calculation of the change in relative blood flow is explained in more detail below with reference to FIGS. 9 and 10 . Instead of the maximum slopes 20 and 22 that were explained with reference to FIGS. 7 and 8 , alternative parameters for determining blood flow can also be chosen if a specific model of the time/contrast curves I/t is assumed for simplicity. [0076] In this simplified model it is assumed that a first time/contrast curve 23 rises linearly until saturation is reached, as revealed in FIGS. 9 and 10 . It is easy to show that the slope 24 of the first simplified time/contrast curve 23 in this rise phase is proportional to two other parameters. The first parameter is the intensity value I′ v at a time instant t′, which must chosen such that it lies before the maximum contrast is reached. The second parameter is the first integral 25 (area under the curve (AUC)) of the first time/contrast curve 23 up to the time instant t′. [0077] The same also applies to the after case shown in FIG. 10 , in which a linear rise of a second simplified time/contrast curve 26 until saturation is reached is likewise assumed. Here too it holds that the slope 27 of the second simplified time/contrast curve 26 in this rise phase is proportional to the intensity value I′ n at the time instant t′. The second integral 28 of the second simplified time/contrast curve 26 up to the time instant t′ can also be drawn upon again here as the second parameter. [0078] Since these two parameters are proportional to the maximum slope, they can likewise be used for calculating the relative flow by formation of the quotients of the values before and after a treatment (or, of course, also referred to a left/right comparison). [0079] The change in relative blood flow can therefore be calculated in a simplified manner as follows: [0000] I′ after /I′ before =AUC after /AUC before ≈m after /m before [0000] where m is the maximum slope and AUC is the area under the time/contrast curve I/t. [0080] It is important to bear in mind that this simplifying assumption of a linear rise together with the associated simplified estimation of the relative blood flow has nothing to do with the above-explained assumption of a stationary state which leads to a simplified estimation of the relative blood volume. [0081] The invention relates to an imaging method for calculating and deriving relative perfusion data, such as blood volume or blood flow for example, from 2-D angiography data, for example 2-D DSA sequences. To clarify: Per se this perfusion data represents absolute values (e.g. where CT perfusion is concerned). In the case of a 2-D image series this restriction to relative perfusion data must be applied, since no depth information at all is available. By waiving the requirement for absolute data and considering relative data by quotient formation it is possible to dispense with the depth information, which, of course, is not contained in the 2-D image sequences. Put more precisely, this dispenses with knowledge of the proportionality constant which relates the mass of the contrast agent along an X-ray beam to the concentration of the contrast agent along said X-ray beam.

1a

This application is a divisional application of U.S. Ser. No. 190,287 (filed May 4, 1988) and now U.S. Pat. No. 4,918,161, itself a continuation-in-part of U.S. Ser. Nos. 100,372 and now U.S. Pat. No. 4,882,422 (filed Sept. 24, 1987 as a CIP of 897,183 and 781,130); 897,183 (filed Aug. 15, 1986 as a CIP of 781,130) and now abandoned; and 781,130 (filed Sept. 26, 1985), and now abandoned, the contents of which are hereby incorporated by reference. FIELD OF THE INVENTION This invention relates to proteins originally isolated from human lung lavage, methods for obtaining said proteins and uses thereof. BACKGROUND OF THE INVENTION Throughout this application various publications are referenced. Full citations for these publications may be found at the end of the specification. The disclosure of these publications are hereby incorporated by reference in order to more fully describe the state of the art to which this invention pertains. Hyaline Membrane Disease (HMD) and Respiratory Distress Syndrome (RDS) are synonymous terms denoting the clinical condition of pulmonary dysfunction in premature infants. The disease is attributable to the absence of surface active material (surfactant) which lines the air-alveolar interface in the lung and prevents collapse of the alveoli during respiration. Current therapy is predominantly supportive. However, recent clinical trials indicate that one promising therapy is the instillation of bovine-derived surfactant into the lungs of the neonate. Surface tension in the alveoli of the lung is lowered by a lipoprotein complex called pulmonary surfactant. This complex consists of phospholipid and 5-10% protein (King, 1982). The protein fraction of the surfactant is composed of nonserum and serum proteins. The major surfactant associated protein is reportedly a 35,000 dalton nonserum, sialoglycoprotein (Shelly et al., 1982; Bhattacharyya et al, 1975; Sueishin and Benson 1981; King et al, 1973, Katyal & Singh, 1981). This protein reportedly seems to be important for the normal function of the pulmonary surfactant (King et. al., 1983; Hawgood et.al., 1985). It is present in reduced amounts in amniotic fluid samples taken shortly before the birth of infants who subsequently develop respiratory distress syndrome (Katyal and Singh, 1984; Shelly et al., 1982; King et al., 1975). Recently the biosynthesis of a 35,000 dalton protein in normal human lung tissue was studied and in an in vitro translation reaction, proteins of 29 and 31 kDa were identified as the primary translation products (Floros et al., 1985). A 35 kDa protein also accumulates in the lungs of patients with alveolar proteinosis (Battacharyya and Lynn, 1978, Battacharyya and Lynn, 1980a). This protein has the same electrophoretic mobility, immunological determinants and peptide mapping as the 35 kDa protein from normal human broncho-alveolar lavage material (Phelps et al., 1984; Whitsett et al., 1985). In addition to the above mentioned proteins, the presence in rat lungs of a number of lower molecular weight surfactant-associated proteins has recently been reported. See D. L. Wang, A. Chandler and A. B. Fisher, Fed. Proc. 44(4): 1024 (1985), Abstract No. 3587 (ca. 9000 dalton rat protein) and S. Katyal and G. Singh, Fed. Proc. 44(6): 1890 (1985), Abstract No. 8639 (10,000-12,000 dalton rat protein). Additionally, a Feb. 6, 1985 press release from California Biotechnology Inc. reports the cloning and "detailed manipulation" of "the gene encoding human lung surfactant protein." However, the press release does not characterize that protein or describe the "detailed manipulations." Two other reports of possible surfactant-related proteins have also been published recently, namely, J. A. Whitsett et al., 1986, Pediatr. Res. 20:460 and A. Takahashi et al., 1986, BBRC 135:527. The present invention relates to a new group of proteins recovered and purified from lung lavage of patients with alveolar proteinosis; methods for obtaining the proteins; corresponding recombinant proteins; antibodies to the proteins (which may be obtained by conventional methods now that the proteins may be obtained in pure form) for use, e.g. in diagnostic products; compositions containing the novel proteins; and methods for using the compositions, e.g. in the treatment of infants afflicted with conditions such as Respiratory Distress Syndrome (RDS), as a drug delivery vehicle in the administration of other therapeutic materials to the lungs or other organs and in the treatment of adult RDS, which can occur during cardiopulmonary operations or in other situations when the lungs are filled with fluid and natural pulmonary surfactant production and/or function ceases. SUMMARY OF THE INVENTION This invention relates to novel purified forms of human proteins useful for enhancing pulmonary surfactant activity, methods for obtaining said proteins in purified form and compositions containing one or more of the proteins. The proteins of this invention include the following: 1. A purified protein, i.e. free or substantially free from other human proteins, characterized by: (a) solubility in 1-butanol at 4° C.; (b) substantial insolubility in 1-butanol at -20° C., i.e. permitting protein precipitation therefrom; (c) containing the peptide sequence FPIPLPY-WL--AL (where "-" represents a non-determined amino acid residue); and, (d) a predominant band having an apparent molecular weight (MW) of ˜6 kd as determined by SDS-PAGE analysis. The protein so defined may be obtained and purified from lung lavage of patients suffering from alveolar proteinosis or may be produced by recombinant means, both as described herein, and should be useful in providing or enhancing enhancing pulmonary surfactant activity. Accordingly, this invention encompasses both the purified natural material as well as recombinant versions thereof. The amino acid composition of the protein as purified from lavage material is shown in Table 3. As described elsewhere herein, the recombinant form of the protein is encoded for by the DNA sequence of Table 1 or by a DNA sequence capable, or capable but for the use of synonymous codons, of hybridizing thereto under stringent conditions "Stringent conditions" as the phrase is used herein are hybrization conditions substantially equivalent to 65° C. in 5×SSC (1×SSC=150 mM NaCl/0.15M Na Citrate). Thus this invention also encompasses proteins which are at least about 90% homologous, and preferably at least about 95% homologous, to polypeptide sequences encoded by the DNA sequence of Table 1. 2. A purified protein, i.e. free or substantially free from other human proteins, characterized by: (a) solubility in 1-butanol at -20° C.; (b) a predominant band having an apparent MW of about 6 kd as determined by SDS-PAGE; and, (c) an amino acid composition substantially as set forth in Table 2. This protein should also be useful in providing or enhancing enhancing pulmonary surfactant activity. TABLE 1__________________________________________________________________________DNA and Corresponding Protein Sequence of 6K Clone__________________________________________________________________________ ##STR1## ##STR2## ##STR3## ##STR4## ##STR5## ##STR6## ##STR7## ##STR8## ##STR9## ##STR10## ##STR11## ##STR12## ##STR13## ##STR14## ##STR15## ##STR16## ##STR17## ##STR18## ##STR19## ##STR20## ##STR21## ##STR22## ##STR23## ##STR24## ##STR25## ##STR26## ##STR27## ##STR28## ##STR29## ##STR30## ##STR31## ##STR32## ##STR33## ##STR34##__________________________________________________________________________ Deduced protein sequence of 6Kd PSP protein is underlined TABLES 2 & 3______________________________________Amino acid compositions of the cold butanolinsoluble and soluble "6 kd" proteins, respectively TABLE 3 TABLE 2______________________________________Asp/Asn 3.06 2.7Thr 1.18 2.0Ser 2.55 2.1Glu/Gln 5.97 1.6Pro 7.64 6.3Gly 7.38 22.9Ala 9.13 3.3Cys 9.14 0.95Val 10.13 5.5Met 3.46 3.4Ile 6.46 4.8Leu 16.23 17.3Tyr 2.31 3.3Phe 1.55 6.3His .34 2.9Lys 1.62 3.6Arg 7.88 1.94______________________________________ (calculated based on MW = 10,000 daltons; ave residue MW = 110) Both proteins are referred to herein as "6 kd" proteins for the sake of simplicity, although it should be appreciated that other minor bands believed to represent incompletely processed forms of the proteins (e.g. at ˜12 kd and/or ˜16-18 kd) are also observed upon SDS-PAGE analysis of the proteins. DETAILED DESCRIPTION OF THE INVENTION The proteins of this invention were obtained by subjecting pulmonary lavage material from an alveolar proteinosis patient to a combination of separation techniques followed by chromatographic purification. More specifically, the lavage material was centrifuged, and the protein-containing pellet so obtained was washed with buffer and extracted with a solvent such as 1-butanol to remove lipids and lipid-associated proteins. The butanol extract was set aside and treated as described below. The 1-butanol-insoluble material was then washed, redissolved in buffer and purified chromatographically. Two proteins were thus obtained which are characterized by a molecular weight of about 35 kd. Those proteins are described in greater detail in in Published International Application WO 86/02037. Butanol-soluble proteins were obtained by cryoprecipitation. More specifically, storage of the 1-butanol extract at -20° C. yielded a precipitate which was purified chromatographically to yield a protein characterized by a predominant band having an apparent molecular weight of about 6 kd (as determined by SDS-PAGE) and the observed amino acid composition set forth in Table 3. A second 6 kd (as determined by SDS-PAGE) protein was obtained by concentrating the supernatant to dryness and purifying the residue chromatographically. The observed amino acid composition of the latter 6 kd protein is set forth in Table 2. The two low molecular weight proteins of this invention differ significantly from each other with respect to amino acid composition, as well as from the protein described by Tanaka, Chem. Pharm. Bull. 311:4100 (1983). Additionally, the N-terminal peptide sequence of the cold butanol-insoluble 6 kd protein was determined (Table 4). As previously mentioned, for the sake of simplicity, both low molecular weight PSP proteins are referred to hereinafter as "6k" proteins based on the approximate apparent molecular weights of their predominant protein bands as determined by conventional SDS-PAGE. It should be understood, however, that the actual molecular weights of these protein bands are presumably in the range of ˜5-˜9 kilodaltons. The fact that these proteins can now be obtained in pure form by the above-described methods made it possible for one to apply conventional methods to elucidate the amino acid composition and sequence of the proteins; to prepare oligonucleotide probes based on the elucidated peptide sequences; to identify genomic DNA or cDNA encoding the proteins by conventional means, e.g., via (a) hybridization of labeled oligonucleotide probes to DNA of an appropriate library (Jacobs et al., 1985), (b) expression cloning (Wong et al., 1985) and screening for surfactant enhancing activity or (c) immunoreactivity of the expressed protein with antibodies to the proteins or fragments thereof; and to produce corresponding recombinant proteins using the identified genomic DNA or cDNA and conventional expression technology i.e. by culturing genetically engineered host cells such as microbial, insect or mammalian host cells containing the DNA so identified, for instance, transformed with the DNA or with an expression vector containing the DNA. By way of example, genes encoding the two 35 kd proteins were cloned as described in detail in WO 86/02037. Additionally, oligonucleotide probes based on the N-terminal sequence of the cold butanol-insoluble 6K protein (See Table 4) were synthesized and were used to screen a cDNA library prepared from human lung mRNA (Toole et al., 1984) as described in greater detail in Example 2, below. Several clones which hybridized to the probes were identified. Based on hybridization intensity one clone was selected, subcloned into M13 and sequenced. Plasmid PSP6K-17-3 was constructed by inserting the cloned cDNA so identified as an EcoRI fragment into the EcoRI site of plasmid SP65 (D. A. Melton et al., 1984, Nucleic Acids Res., 12:7035-7056). PSP6K-17-3 has been deposited with the ATCC under accession No. ATCC 40245. The nucleotide sequence of the cloned cDNA insert is shown in Table 1. TABLE 4______________________________________ ##STR35##______________________________________ (-) = Not determined (positions 8,11 & 12 were unidentified) As those skilled in the art will appreciate, the cDNA insert in PSP6K-17-3 contains an open reading frame encoding a protein having a molecular weight of over 40kd. It is believed that the primary translation product is further processed, e.g., by Type II pneumocytes (Alveolar Type II cells), to yield the approximately 6K protein. It is contemplated that the cloned cDNA, portions thereof or sequences capable of hybridizing thereto under stringent conditions may be expressed in host cells or cell lines by conventional expression methods to produce "recombinant" proteins having surfactant or surfactant enhancing activity. With respect to the cloned approximately 6K protein, this invention encompasses vectors containing a heterologous DNA sequence encoding the characteristic peptide sequence Ile through Cys corresponding to nucleotides A-656 through C-757 of the sequence shown in Table 1, i.e., IKRIQAMIPKGALAVAVAQVCRVVPLVAGGICQC. One such vector contains the nucleotide sequence. ##STR36## Other vectors of this invention contain a heterologous DNA sequence encoding at least a portion of the characteristic peptide sequence substantially as depicted in the underlined peptide region of Table 6, i.e., FPIPLPYCWLCRALIKRIQAMIPKGALAVAVAQVCRVVPLVAGGICQCLAERYSVILLDTLLGRML. One such vector contains the DNA sequence substantially as depicted in the underlined nucleotide sequence of Table 1, i.e., ##STR37## Another exemplary vector contains a heterologous DNA sequence, such as the nucleotide sequence depicted in Table 1, which encodes the full-length peptide sequence of Table 1. DNA inserts for such vectors which comprise a DNA sequence shorter than the full-length cDNA of PSP6K-17-3, depicted in Table 1, may be synthesized by known methods, e.g. using an automated DNA synthesizer, or may be prepared from the full-length cDNA sequence by conventional methods such as loop-out mutagenesis or cleavage with restriction enzymes and ligation. Vectors so prepared may be used to express the subject proteins by conventional means or may be used in the assembly of vectors with larger cDNA inserts In the former case the vector will also contain a promoter to which the DNA insert is operatively linked and may additionally contain an amplifiable and/or selectable marker, all as is well known in the art. The proteins of this invention may thus be produced by recovering and purifying the naturally-occuring proteins from human pulmonary lavage material as described herein. Alternatively, the corresponding "recombinant" proteins may be produced by expression of the DNA sequence encoding the desired protein by conventional expression methodology using microbial or insect or preferably, mammalian host cells. Suitable vectors as well as methods for inserting therein the desired DNA are well known in the art. Suitable host cells for transfection or transformation by such vectors and expression of the cDNA are also known in the art. Mammalian cell expression vectors, for example, may be synthesized by techniques well known to those skilled in this art. The components of the vectors such as the bacterial replicons, selection genes, enhancers, promoters, and the like may be obtained from natural sources or synthesized by known procedures. See Kaufman, Proc. Natl. Acad. Sci. 82: 689-693 (1985). Established cell lines, including transformed cell lines, are suitable as hosts. Normal diploid cells, cell strains derived from in vitro culture of primary tissue, as well as primary explants are also suitable. Candidate cells need not be genotypically deficient in the selection gene so long as the selection gene is dominantly acting. The host cells preferably will be established mammalian cell lines. For stable integration of vector DNA into chromosomal DNA, and for subsequenct amplification of integrated vector DNA, both by conventional methods, CHO (Chinese hamster Ovary) cells are generally preferred. Alternatively, the vector DNA may include all or part of the bovine papilloma virus genome (Lusky et al., Cell, 36:391-401 (1984) and be carried in cell lines such as C127 mouse cells as a stable episomal element. Other usable mammalian cell lines include HeLa, COS-1 monkey cells, mouse L-929 cells, 3T3 lines derived from Swiss, Balb-c or NIH mice, BHK or HaK hamster cell lines and the like. Cell lines derived from Alveolar Type II cells may be preferred in certain cases such as expression of the 6K protein (alone or with one or more other proteins of this invention) using the cDNA insert from PSP6K-13-7 or a fragment thereof. Stable transformants then are screened for expression of the product by standard immunological or enzymatic assays. The presence of the DNA encoding the proteins may be detected by standard procedures such as Southern blotting. Transient expression of the DNA encoding the proteins during the several days after introduction of the expression vector DNA into suitable host cells such as COS-1 monkey cells is measured without selection by activity or immunological assay of the proteins in the culture medium. In the case of bacterial expression, the DNA encoding the protein may be further modified to contain preferred codons for bacterial expression as is known in the art and preferably is operatively linked in-frame to a nucleotide sequence encoding a secretory leader polypeptide permittng bacterial secretion of the mature variant protein, also as is known in the art. The compounds expressed in mammalian, insect or microbial host cells may then be recovered, purified, and/or characterized with respect to physicochemical, biochemical and/or clinical parameters, all by known methods. One or more of the proteins of this invention may be combined with a pharmaceutically acceptable fatty acid or lipid such as dipalmitoylphosphatidyl choline or with mixtures of such fatty acids or lipids which may be obtained from commercial sources or by conventional methods, or with natural surfactant lipids to provide a formulated pulmonary surfactant composition. Natural surfactant lipids may be extracted by known methods from lung lavage, e.g. bovine or human lung lavage. Typically the weight ratios of total lipids to total proteins in the composition will be about 20:1 to about 100:1. At the levels currently being tested in clinical trials, one dose of the surfactant composition corresponds to 1-2 mg of total protein and 98-99 mg of total lipid. It is contemplated that certain subcombinations of one or more of the proteins of this invention with one or more of the proteins described in WO 86/02037 and compositions containing such subcombinations may be especially useful in the treatment of patients with particular clinical indications. EXPERIMENTAL EXAMPLES EXAMPLE1 Isolation and Characterization of the Surfactant Associated Proteins Pulmonary lavage (50 ml) from an alveolar proteinosis patient was centrifuged at 10,000×g for 5 min. The pellet was collected and washed 5 times in 20 mm Tris HCl, 0.5M NaCl, pH 7.4. The lipids and lipid-associated proteins were extracted from the washed pellet by shaking with 50 ml 1-butanol for 1 hr at room temperature. The butanol extract so obtained was stored at -20° C. causing precipitation of one of the low MW proteins. The precipitate was collected by centrifugation and dried under vacuum. The butanol layer containing butanol-soluble protein was evaporated to dryness. The precipitated cold butanol insoluble protein and the cold butanol-soluble protein were then purified in parallel by the same method as follows. Each crude protein was separately dissolved in CHCl 3 : MeOH (2:1, v/v), applied to Sephadex LH20 columns and eluted with CHCl 3 :MeOH (2:1). The proteins were then analyzed by SDS-PAGE. Fractions containing the protein were pooled and evaporated to dryness. Amino acid composition was determined by hydrolysis in 6N HCl at 110° C. for 22 hrs followed by chromatography on a Beckman model 63000 amino acid analyzer. N-terminal sequence was determined on an Applied Biosystems 470A sequencer Molecular weights were determined on 10-20% gradient SDS polyacrylamide gels. EXAMPLE 2 Screening of the cDNA Library and Sequencing of Clones for the 6Kd Proteins Based on the first six amino acids of the sequence shown in Table 4 an oligonucleotide probe was synthesized. The probe consisted of six pools of 17 mers. Three of the pools each contained 128 different sequences, and three of the pools each contained 64 different sequences. Based on the first seven amino acids two pools of 20 mers were synthesized. These pools contained either 384 or 192 different sequences. A cDNA library from human lung m was prepared as described in Toole et al., (1984) and screened with the total mixture of the six pools using tetramethylammoniumchloride as a hybridization solvent (Jacobs et al., 1985). Approximately 100,000 phage were screened, and 100 phage which hybridized to the probe were plaque purified. The phage were then pooled into groups of 25 and screened with the individual 17 mer and 20 mer pools. Six phage which hybridized most intensely to one of the 20 mer oligonucleotide probes and one of the corresponding 17 mer pools (pool 1447 containing 128 different sequences) were plaque purified. The 17 mer pool 1447 was divided into four pools of 32 different sequences and hybridized to a dot blot of DNA prepared from these phage. Based on the hybridization intensity, DNA from one of these six phage were subcloned into M13 for DNA sequence analysis. A sequence corresponding in identity and position to the amino acids shown in Table 4 was obtained, confirming that the isolated clone coded for the approximately 6 kd cold butanol-insoluble protein found in the lavage material of alveolar proteinosis patients (see above). The first clone obtained was presumed to be an incomplete copy of the mRNA because it lacked an initiating methionine, and was used to isolate longer clones. Two clones were oompletely sequenced by generating an ordered set of deletions with Bal 31 nuclease, recloning into other M13 vectors and sequencing via the dideoxynucleotide chain termination procedure (Viera and Messing, 1982; Sanger et al., 1977). One clone corresponded to a full-length copy of the type referred to as 17 (Table 1), the second began at nucleotide 148 of clone 17. Sequence of the 5' end of a third clone confirmed the sequence of the 5' end of clone 17. The clones are identical throughout the coding region and differ only at two positions in the 3' untranslated region. As those of ordinary skill in this art will appreciate, the cloned gene may be conveniently obtained by excision from PSP6K-17-3 (ATCC No. 40245) or may be recloned using sequence information provided herein in Table 1. REFERENCES 1. Bhattacharyya, S. N., and Lynn, W. S. (1978) Biochem. Biophys. Acta 537, 329-335 2. Bhattacharyya, S. N., and Lynn, W. S. (1980) Biochem. Biophys. Acta 625, 451-458 3. Bhattacharyya, S. N., Passero, M. A., DiAugustine, R. P., and Lynn, W. S. (1975) J. Clin. Invest. 55, 914-920 4. Floros, J., Phelps, D. S., and Taeusch, W. H. (1985) J. Biol. Chem. 260, 495-500 5. Hawgood, S., Benson, B. J., and Hamilton, Jr. R. L. (1985) Biochemistry 24, 184-190 6. Hunkapiller, M. W. and Hood, L. E. (1983) Methods in Enzymology 91, 486. 7. Jacobs, K., Shoemaker, C., Rudersdorf, R., Neil, S. D., Kaufman, R. J., Mufson, A., Seehra, J., Jones, S. S., Hewick, R., Fritsch, E. E., Kawakita, M., Shimizu, T., and Miyake, T. (1985) Nature (Lond.) 313, 806-810. 8. Kafatos, E., Jones, W. C., and Efstratiadis, A. (1979) Nucleic acid Rest. 7, 1541-1552. 9. Katyal, S. L., Amenta, J. S., Singh, G., and Silverman, J. A. (1984) Am. J. Obstet. Gynecol. 148, 48-53. 10. Katyal, S. L. and Singh, G. (1981) Biochem. Biophys. Acta 670, 323-331. 11. King, R. J., Carmichael, M. C., and Horowitz, P.M. (1983) J. Biol. Chem. 258, 10672-10680. 12. King, R. J. (1982) J. Appl. Physiol. Exercise Physiol. 53, 1-8. 13. King. R. J., Klass, D. J., Gikas, E. G., and Clements, J. A. (1973) Am. J. Physiol 224, 788-795. 14. King, R. J., Ruch, J., Gikas, E. G., Platzker, A. C. G., and Creasy, R. K. (1975) J. of Applied Phys. 39, 735-741. 15. Laemmli, U. K. (1970) Nature (Lond.) 227, 680-685. 16. Miller, J. S., Paterson, B. M., Ricciardi, R. P., Cohen, L and Roberts, B. E. (1983) Methods in Enzymology 101p. 650-674. 17. Phelps, D. S., Taeusch, W. H., Benson, B., and Hawgood, S. (1984) Biochem. Biophs. Acta, 791-226-238. 18. Shelley, S. A., Balis, J. U., Paciga, J. E., Knuppel, R. A., Ruffolo, E. H., and Bouis, P. J. (1982) Am. J. Obstet. Gynecol. 144, 224-228. 19. Sigrist, H., Sigrist-Nelson, K., and Gither, G. (1977) BBRC 74, 178, 184. 20. Sueishi, K., and Benson, G. J. (1981) Biochem. Biophys. Acta 665, 442-453. 21. Toole, J. J., Knopf, J. L., Wozney, J. M., Sultzman L. A., Bucker, J. L., Pittman, D. D., Kaufman, R. J., Brown, E., Shoemaker, C., Orr, E. C., Amphlett, G. W., Foster, W. G., Coe, M. L., Knutson, G. L., Eass, D. N., Hewick, R. M. (1984) Nature (Lond.) 312, 342-347. 22. Whitsett, J. A., Hull, W., Ross, G., and Weaver, T. (1985) Pediatric Res. 19, 501-508. 23. Wong, G. G. et al., 1985, Science, 228:810-815

1a

This application is a Continuation-in-Part of U.S. Ser. No. 08/230,197 filed on Apr. 20, 1994 of the same title and now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to an assembly of extendable, or projectable, and retractable spikes for use with footwear. More specifically, in the working embodiment, an array or assembly of ground-engaging spikes is encased in the sole-heel matrix of a piece of footwear and mechanized so that the spikes may be projected from the sole-heel in a surface-contacting protrusion or retracted when their gripping facility is no longer desired. 2. Discussion of the Relevant Art Structures similar to that described above are known in the art. The concept of a projectable and retractable anti-slip device is employed in the shoe or boot footwear associated with hiking and skiing, and could be conceivable employed in other sports such as golf. In my search for relevant art, I discovered several patents which taught purely mechanical actuation devices for projectable and retractable spikes. U.S. Pat. No. 3,793,751 discloses a retractable spike apparatus for use in a golf shoe and the like. By turning a knob which projects or protrudes from the heel of the shoe, two eccentrically mounted shafts, that are coupled by a flexible, intermediate shaft, effect a camming action that forces each of two strap-captured plates downward. The plates carry a plurality of spikes which are caused to protrude through the heel-sole portion of the shoe into ground contact. Further rotation of the camming shafts causes their retreat from the plates, allowing them to be rebiased in the upward position and withdrawn into the sole-heel ensemble. A ski boot traction device, disclosed in U.S. Pat. No. 3,717,238, teaches a retractable anti-slip spike assembly encased in a ski shoe and consisting of a tubular metal casing transversely embedded in the sole and the heel of the shoe. The casing has a longitudinally rotatable camming member mounted over a longitudinal plate element that is provided with a plurality of depending spikes which are accessible through openings in the bottom wall portion of the shoe casing. The plate member is spring-biased upwardly in order to retract the spikes while the rotatable camming member may be manually operated through use of a radial handle element which is accessible to the user. As with '751, this device utilizes at least one camming member to drive the spikes downward through a plurality of openings in the sole-heel of the boot. Still employing a camming action, but using a spike array that need not be afforded openings in the sole-heel ensemble, U.S. Pat. No. 4,375,729, for footwear having retractable spikes, employs a mechanism for selectively extending and retracting the spikes through the use of finger pressure on an enclosed heel cam extension bar. By digital manipulation, a heel locking mechanism is released and a rigid cam member is moved to a forward or rearward direction. The spikes are mounted on a resilient plate in a retracted position and the plate is superimposed by the cam member. As the cam member slides over the spike plate, individual cam portions of the upper member slide over the spike bases and push them downward, causing them to extend beneath the sole-heel plane. A great advantage of the '729 device is that the spike driving mechanism is relatively inaccessible through the base of the shoe or boot which encases the entire spike assembly. German Patent No. 191178, issued in 1907 discloses an early attempt to translate a longitudinally disposed gang-bar by means of an articulated knuckle which is rotated by a key mechanism. Most interesting is the use of a metal framework for mounting thereon the pivotation axis of several cleats. This device was readily amenable to strap-on (the shoe) usage and in the northern United States and Canada was commonly referred to as an "ice creeper" or "ice walker". The articulated portion is restricted only to the knuckle mechanism, the gang-bars of the disclosure consisting only of fairly rigid ribbonous shafts. Straps for donning the creepers are affixed, as with all devices of this type, near heel and mid-sole portions of the frame. State-of-the art patent, U.S. Pat. No. 5,337,494 discloses a cleated shoe mechanism that is actuated to move spikes into and out of a plurality of "pits" located in the bottom of the sole. This mechanism is housed or encased in the sole-heel portion of a shoe and thus, the pits are a useful adjunct to my invention. Finally, the Brookstone (Reg. TM) Catalog of Hard To Find Tools (Brookstone T-1-95A1; Mexico, Missouri--Copyright 1994) features a cover advertisement for strap-on "ice walkers" that are useable with low-heel dress shoes. It is clear that the removable facility is contemplated with such "strap-ons" because of nonretractability of the cleats. In order to provide a noteworthy advancement in this field, I have devised an extensible and retractable shoe spike assembly, the spikes of which are extensible from and retractable into pits located in the firm, cast portions of the sole and heel, that is the base, of a shoe or boot. Minimizing apertures in these portions of the footwear obviates a degradation of the mechanism due to fouling by the entrance into the extension-retraction mechanism of soil, mud or other debris. On the other hand, the simple and elegant mechanization of '751 could not be ignored, nor could the fact that is it operated without the use of tools and can be readily manipulated by a youngster or a person's gloved hand. Very little technique is required in a simple rotation of a knob. 3. Incorporation by Reference Because they disclose first of their kind mechanisms or state-of-the art, the patents U.S. Pat. No. 5,337,494 and German No. 191178 are incorporated by reference. To the extent that is discloses strap-on walking cleats, the Brookstone (Reg. TM) Catalog is also incorporated by reference. SUMMARY OF THE INVENTION I have devised an improved lockable, extensible and retractable shoe spike assembly that is to be housed within a footwear base having interior channeling or spatial equivalent that includes both a forward sole portion and a rearward heel portion. This assembly consists in three subassemblies: a locking subassembly; a transmission network for conveying a motivating force throughout the assembly; and, a spike movement subassembly. The locking subassembly is housed substantially in the heel portion and includes a lockable shaft, a portion of which protrudes beyond the heel margin, and to which is applied two types of force for motivating the spike movement subassembly. The first motion, a reciprocative one, is used to lock and unlock the heel-borne mechanism; while a rotational or angular force is conveyed by the shaft to a motion translation (conversion) mechanism that translates the rotational motion of the shaft to a reciprocal motion that is transmitted to the spike array. To achieve this motion translation, I have coupled the shaft to a dual cylinder mechanism, the first or outer cylinder being a fixed bushing within which the inner and hollow cylinder is allowed to rotate when driven by the shaft coupled thereto. The inner cylinder of the aforesaid duality is helically slotted, that is, it bears slots which penetrate its hull and effect at least a partial helix. A bolt, having pin protrusions or detents in opposition on one end thereof, is fitted into the inner cylinder so that the detents seat in the opposing helical slots. Thus, as the inner cylinder is rotated by the shaft coupled thereto, the bolt which occupies the core of the inner cylinder is caused to traverse a portion of that cylinder's length, thus effecting a reciprocative motion induced by the rotation or angular motion of the shaft-coupled inner cylinder. The transmission network, receiving the translation mechanism-generated reciprocative motion (also termed force) conveys it to a plurality of pivotally mounted levers via several straight shafts. An advantage obtained by my present invention is the versatility in the type of sole into which the device can be incorporated. Many types of footwear have a highly flexible sole which do not interface well with other inventions for providing retractable retrusion. My invention, however, uses multiple short straight shafts, which are hingedly connected by link pins. This configuration, as well as the placement of the connectors at the major flex points of the sole, enable my invention to function properly without significantly inhibiting the normal flex of the sole. I have, therefore, located four link pins in the half of the sole closest to the toe portion of the sole, where most flexing takes place. The levers are fixed to a series of roller bars which act as rotatable fulcrums because they are mounted in respective fixed tubular bushings. The roller bars are positioned in the heel and sole portions of the footwear base so that only incremental portions of their surfaces are exposed outside the heel and sole, and then only through a plurality of shallow depressions or pit areas in the base. When a reciprocative force is applied to the pivotal drive levers of the roller bars, the exposed increments effect an orthogonal or 90° rotation, which is described simply as forward and down or rearward and up. In each of these incrementally exposed areas of the roller bar are inserted a respective number of threadably removable and replaceable spikes. Thus, the only spring biasing which I employ is that which allows me to lock and unlock the rotatable shaft. Thereafter, rotational motion applied to the shaft will extend or retract the spikes in a most positive and secure manner. Irrespective of the spike disposition, spring biasing will return the rotatable operating shaft to a locked position and the spikes, in whatever mode, will be secured. The base is, in the preferred form, a casting of a firm, durable substance such as rubber. Alternatively, it is a strong frame-work, both articulable and of a strap-on construction; it may be made of metal. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan of the invention partially sectionalized and in the preferred form; FIG. 2 is a side elevation of the invention within the (phantom) confines of the base; FIG. 3 is an exploded view of selected portions of the invention; FIG. 4 is a partially exploded view of selected portions of the invention; FIG. 5 is an elevational section of FIG. 1 showing a spike mechanism; FIG. 6A is a partial isometric illustration of the heel showing spikes retracted; FIG. 6B is the FIG. 6A section showing spikes projected; FIG. 7 is an isometric view of the operating shaft and key; FIG. 8 is an end sectional view of the inner cylinder and associated mechanism as seen from 8--8 of FIG. 2; FIG. 9 is a rear sectional view of the dual cylinder apparatus looking forward from pin P3; and FIG. 10 is a sectional view of the locking mechanism as seen from 10--10 of FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Before presenting the details of my invention, I would first make the following definition of terms: "footwear base" shall mean the ground-contacting part of a strap-on cleat frame, shoe, boot, etc., of varying thickness whether or not hollow; "encased" shall mean housed or substantially enclosed within; and, "extend" and "project" root words shall have the same connotation irrespective of grammatical usage. Referring now to FIG. 1, the invention 10 is shown in plan, encased in a footwear base 12, which is preferably cast but may consist in a covered frame of say, high density plastic or metal. I will not digress into means for making the footwear base since a great deal is already known in the art or/and incorporated by reference. Locking and transmission subassemblies are situated predominantly in the heel portion of the base, the parts thereof being now disclosed sequentially beginning with the mechanism actuating knob 14 with integral collar 18. The collar 18 is set on shaft 20 by means of screw 16 and passed through U bracket 22, coil spring 23, keeper plate 24 and backer plate 25 which is assembled with bolts 17 (not clearly shown) and nuts 19. The aforesaid parts, items 17 and 19-25 comprise, for the most part, the bearing unit for the shaft 20 as well as the keeper mechanism for key 21 (not shown). This keeper-bearing mechanism is permanently fixed or set into the footwear base matrix or casting. Shaft 20 exits the keeper-bearing assembly passing through bushing B1 (not itemized) into the rear portion of hollow inner cylinder 26 which, with its bushing cylinder 28, that is also firmly fixed to or set in the footwear base comprises the critical dual cylinder or cylinder pair which is fundamental to the motion translation process that I use in my invention. As will be disclosed hereinafter, the cylinder pair 26, 28, with internal mechanisms, converts the rotary motion applied to the shaft 20 to a reciprocative motion effected by bolt 30, which is inserted into the inner cylinder 26. Hereinafter, inner cylinder 26 will take on the nomenclature "slotted cylinder 26" as discussion ensues as to the internal mechanisms of this dual cylinder apparatus. To this point, the plan view of FIG. 1 has been addressed; however, the reader is urged to consider FIG. 2, an elevational view of the FIG. 1 apparatus for the remainder of this discussion concerning the overall invention assembly 10. The reciprocative motion or force effected by bolt 30 is coupled to link shaft 32 and immediately to the forwardmost spike mechanism by the link assembly LA. The connection of the link shaft 32 to both bolt 30 and link assembly LA is by way of link pins 39, seen throughout this apparatus. From linking point LA the motion and force transmission digresses to the apparatus contained in the heel and also forward in the footwear base to the sole portion. The first power take-off is at the forwardmost spike roller mechanism of the heel. Reciprocative motion derived from the bolt 30 is transferred to a pivotally connected lever 36 and from there to a roller bar 38 in which the lever 36 is firmly fixed. The roller bar 38 rotates in sleeve bushing 40, thus effecting a roller type fulcrum. Proximate one of the ends of the forwardmost heel roller assembly is another lever 36 lying in the same plane as the aforementioned lever with respect to the roller bar 38. This is the only roller bar on which two or more levers 36 are seen to appear. At this point, the remaining heel roller assembly typifies the remaining roller assembly found in the sole of the shoe: lever 36 is linked by link pin 39 to short shaft 35 which is, in turn, connected to another lever by a similar link pin 39 which motivates a second of the heel-disposed roller bar 38. By concatenating lever 36 ends with succeeding short shafts 35 via link pins 39, the aforementioned apparatus may be used to gang as many roller assemblies as required. This is clearly seen in FIGS. 1 and 2 in respect of the area forward of the heel portion, generally termed the sole portion. There, main shaft 34 duplicates the heel roller bar assembly in every respect. Referring specifically to FIG. 2, roller bars 38 residing in their tubular bushings 40 are seen in a sectional elevation taken at 2--2 of FIG. 1. The reader will note that portions of the footwear base 12 are provided cut out ports 13 which, according to a manufacture's desire, may be disposed as treads in the sole and heel of the base. As mentioned earlier, since the tubular bushings 40 are fixed to or in the footwear base, a small increment of the bushing length and arcuate surface must be opened to allow a depending spike 42 to translate between the positions shown in FIG. 2, that is between the projected or extended position shown in solid illustration and the retracted, shown in phantom. This increment is denoted by I as seen in the spike apparatus (also FIG. 3). Having described or defined, in FIGS. 1 and 2, all visible features, I will now discuss the main parts of the spike assembly apparatus with reference to the exploded illustration of FIG. 3. As in FIG. 1, the description in detail of FIG. 3 begins at the rearmost portion of the spike assembly apparatus beginning with knob 14 secured to rotatable shaft 20 through the collar 18 securing mechanism 15, 16. The rectangular key 21 is secured to the shaft 20 by pin P1. Pin P2 seen at the left end of shaft 20, rearward of slot G4, is placed in the shaft before any further assembly. The functions of P2 and G4 will be explained later. Using machine bolts 17, U bracket 22, biasing coil spring 23, base plate 24, retaining plate 25 and nuts 19, the locking and rotational force application subassembly is assembled as shown and fixed in the matrix of the footwear base. Bushing B1 is placed at the end of the shaft 20 which protrudes from the locking subassembly toward the left of the illustration (which is the "forward" direction of apparatus appearance). A motion translation (conversion) subassembly, consisting of a slotted 27 rotatable cylinder 26 is hollowed so that an essentially round bar 30 may slide therethrough. An outer cylinder, a bushing cylinder 28, is fitted over the slotted cylinder 26 and fixed also in the footwear matrix to act as a bushing for the slotted cylinder. The bar 30 is fitted with pin P3 at its rearmost end such that the tips of pin P3 protrude from the surface of the bar to the extent that the ends will comfortably fit into the slots 27 of the inner slotted cylinder 26. Thus, as cylinder 26 is caused to rotate in its bushing 28, the ends of pin P3, being constrained to remain in a vertical position as shown, are drawn by the helical slots 27 of cylinder 26 in reciprocative fashion to the left or right (forward or rearward) as is apparent from the illustration. At this point, the reader must realize that the sizing of parts in all illustrations are not totally accurate, but rather presented as they are for the purposes of exposition and to impart ease of understanding. Some of the minor parts and details are not herein enumerated, but will be discussed later during explanation of the remaining drawings. The leftmost portion of the FIG. 3 illustration typifies the transmission network by which the reciprocating force resulting from movement of round bar 30 is conveyed via link shaft 32 to other link shafts, main shaft 34 and to the roller bar (fulcrum) assembly 38, 40 via levers 36 and link pins 39. Finally, in the FIG. 3 illustration, a single spike 42 is shown with its apparent disposition in roller bar 38, a portion of which is exposed, as the increment I, through roller bushing 40. A spike removal/insertion tool 50 is isometrically illustrated and is self explanatory. FIG. 4 is an isometric, exploded illustration of the apparatus lying predominantly in the heel portion and is provided in order to explain the function of pin P2 and slot or groove G2. As before, the reader is cautioned not to seek accuracy in the size and shape of the elements presented herein since they are presented for illustrative purposes only. Forward of the locking and force application subassembly, rotational shaft 20 (also termed "key shaft") is slotted and pinned at its foremost end. The pin P2 has ends which protrude from the surface of the shaft 20. Cylinder 26 is either fitted with an adapting cylinder 26' or, if suitable, its interior is longitudinally grooved G2 to receive the protruding ends of pin P2. It is this pin and groove combination which allows rotational motion and force of shaft 20 to be transferred to the inner cylinder 26. The purpose for slot G4 will be understood later during the discussion of FIG. 8. During the discussion of FIG. 2, there was pointed out the two positions to which the spikes of the invention may be driven. FIGS. 5, 6A and 6B carry this disclosure a bit further and the reader may readily discern the placement of parts and sections of the spike rotation apparatus as formerly enumerated. Moving to FIG. 7, there is depicted an elevational view of key shaft 20, bearing the rectangular key 21 device, pin P2 and with slot G4 and screw 16--receiving hole 15'. Whereas FIG. 1 illustrated the components to which, and with which, the FIG. 7 device was connected, FIG. 8, a cross section of the dual cylinder motion translation subassembly, better illustrates the functional relationship between the shaft 20 and itself. In FIG. 8, bushing cylinder 28 cylindrically envelopes slotted cylinder 26. An adaptive cylinder 26', integral with slotted cylinder 26 provides grooving G2 and the necessary inner diameter to accept the left end of shaft 20 as shown in FIG. 7. The exposed ends of pin fitted in grooves G2, are the primary guidance and force transfer mechanism between the shaft 20 and the inner slotted cylinder 26; the duo assure alignment between P4/G4. During locked modes of the invention, slot G4 of shaft 20 resides over and captures pin P4, which bisects and is securely fixed in slotted cylinder 26. Thus, when in a locked mode, that is, shaft 20 bearing fixed key 21 spring biased forwardly so that key 21 resides in keeper aperture K, the locking assembly securely captures pin P4 and prevents any further movement of the slotted cylinder 26. Forward of the FIG. 8 apparatus, the dual cylinder motion translation means is shown in cross section at FIG. 9. Therein, bushing cylinder 28 cylindrically envelopes slotted cylinder 26 which contains therein bolt 30. Bolt 30, transfixed by pin P3 is constrained from rotational movement by residence of pin P3 in the 0°-180° longitudinally disposed grooves G5 in bushing cylinder 28. Regressing somewhat to the locking assembly, FIG. 10, taken at 10--10 of FIG. 2, is a sectional elevation of the key and keeper device of the invention. The essential part, key 21 of shaft 20 is seen residing in keeper aperture K of keeper plate 24. The pin depicted is P2, which is superimposed illustratively over pin P1. The reader will recall that pin P2 (from FIG. 7) is a most essential device in that its communication in groove G2 of the slotted cylinder apparatus 26, 26' is necessary to assure rotational motion force transfer from shaft 20 to the slotted cylinder 26. Although I have described my invention in a generalized footwear base, the routineer will recognize that its applications, namely the moving of a translational shaft by rotary motion is not restricted solely to the disclosed embodiments. It should also be realized that the footwear base may serve as a strap-on "ice walker" or "creeper", as well as the sub-sole or ground-contacting sole of a shoe or boot. Having defined in detail the working embodiment of my invention, I would now commend its usage to those in the field who would apply it within the spirit of the instant disclosure. Such use is strongly encouraged by me consistent with the hereinafter appended claims.

1a

FIELD OF THE INVENTION [0001] The present invention is directed to a system for automatically steering a utility vehicle, wherein signal quality information from two position sensors is evaluated and used to steer the utility vehicle along an intended target path. BACKGROUND OF THE INVENTION [0002] WO 94/24845 A and U.S. Pat. No. 6,128,574 disclose an automatic steering system for agricultural vehicles, wherein the system locates the vehicle on the basis of its immediate position and its intended target path. The position is determined from a location sensor receiving satellite location signals (GPS or DGPS). In this way the automatic steering system can continue to steer the vehicle even if the satellite location signals fail. U.S. Pat. No. 6,128,574 discloses that the utility vehicle is equipped with operating direction sensors and velocity sensors. Both references propose that the signals of the satellite system be supplemented by sensors attached to the utility vehicle, that can detect, for example, the crop edge of a standing crop or windrow. The crop edge can be detected, according to WO 94/24845 A, by an image operating system or, according to U.S. Pat. No. 6,128,574, by a reflex location system (such as, for example, a laser scanner) or by a harvested edge orientation system relying on mechanical contact with the crop. [0003] In both cases cited above, the steering is performed exclusively on the basis of a map previously stored in memory, that defines the path to be followed. However, in some applications no map of the area to be processed may be available and the generation of a map would be uneconomical. SUMMARY OF THE INVENTION [0004] It is an object of the present invention to provide an improved automatic steering system for a utility vehicle that is highly accurate. [0005] The automatic steering system of the present invention is provided with a first position sensor for generating a first position signal and a second position sensor for generating a second position signal. The first position sensor and the second position sensor are independent of one another. Both position signals are communicated to a controller having a memory. The controller is also supplied signal quality information about the quality of at least one of the position signals. The controller evaluates the position signals based on the signal quality information and weights the position signals accordingly to calculate the position of the vehicle and select the vehicle's target path. The target path is selected from several target paths. The selected target path is the best path that corresponds to the position of the vehicle. Based on the position signal and the selected target path, the controller generates a steering signal that is communicated to a steering controller for steering the vehicle. [0006] The controller can steer the vehicle along a target path defined by a fixed object (boundary of operation). The fixed object could be a crop edge that the vehicle is steered along during a harvesting operation. In this case the target path information corresponds to the intended position of the utility vehicle relative to the boundary of operation. A digital map generated in advance of the area to be processed is not required. If the signal quality information indicates the accuracy of the position signal is not adequate, the controller then derives the selected target path from previously recorded position information that was automatically recorded in the memory in the form of a map. Storing the position information is in the form of a learning operation. The steering then is controlled on the basis of the signal form the other position sensor. The target path information then corresponds to the map that was stored in memory to define the path to be followed. If it is found later on the basis of the signal quality information that the position signal detecting the boundary of operation is again adequate, the latter can again be used for steering the utility vehicle. Similarly, if the vehicle is steered from the satellite signals generated position signal along a path from a stored map, and the satellite signals cease, the other position sensor sensing the boundary of operation and a movement sensor can be used by the controller to generate a steering signal, the target path information now no longer corresponds to the map, but to the intended transverse distance to the boundary of operation. [0007] In this way it becomes possible to equip an agricultural utility vehicle with several different position sensors and to automatically steer it on the basis of the most appropriate target path information conforming to the most appropriate position signals. The target path information is not necessarily derived from a pre-stored map, but from information that is relatively easy to obtain, for example, the desired position of a boundary of operation or information about a path that has already been covered. [0008] In a preferred embodiment of the invention it is proposed that the controller gives weighted consideration to the position signals of the first and the second position sensor in the generation of the steering signal on the basis of the quality information that has been supplied to the controller. If the quality information points to a relatively high degree of accuracy of the first position signal, that first signal is considered exclusively or at least to a great proportion in the calculation of the steering signal. The second position signal is considered only in a small proportion or not at all. Analogously the first position signal is ignored or considered only in a small proportion, if the quality information points to a low accuracy of the first position information. With approximately median accuracy of the first and the second position signals, the first and the second position signal can be considered with equal weight. The target path information is selected accordingly. [0009] Preferably the controller is provided with signal quality information for both position signals. The controller also uses this information, in order to establish which position signal is considered and to which degree it is considered. [0010] The first position signal can be generated by satellite signals that can be generated by the GPS (global positioning system). However, the use of an inertial navigation system is also conceivable. [0011] The second position signal can be generated by a local sensor on the agricultural utility vehicle. The local sensor can detect the movement of the utility vehicle (start, direction and velocity and possibly also the inclination of the terrain). Alternatively or in addition the local sensor is a sensor that can detect the position of the utility vehicle relative to a stationary object, particularly the boundary of an operation. Sensors of this type are sufficiently well known in the form of image processing systems, laser scanning sensors or mechanical scanning arrangements for the detection of rows of crop as are used in automatic steering systems for harvesting machines. Sensors for measurement of width of cut on cutter heads can also be used. [0012] With laser scanning sensors there is occasionally the problem that the sensors can no longer recognize an edge. This problem occurs at that time, for example, when the edge is relatively low, several crop edges lie side-by-side, the harvesting machine rounds a curve or at the beginning of a harvest operation wherein the crop edge cannot be recognized. Therefore in the preferred embodiment, the controller stores previously position information indicating the path covered by the vehicle and the expected position of the boundary of operation. In that way if the headlands are harvested from the field at the beginning of a harvesting operation and if thereby the outline of the field is known to the controller by its record of the positions previously covered, then information is available as to which portion of the field has been harvested. This information can be utilized if the laser scanning sensor is not in the position to detect the boundary of operation automatically. This information can also be used upon the entry into the stand of the crop in order to establish the position of the boundary of operation so as to orient the sensor. The prediction of the controller relies on the assumption that the paths of the operation run steadily and parallel to the preceding path. Only edges corresponding to such paths are used by the laser scanning sensor as possible locations for the crop edge. Crop edges that extend at an angle or at implausible spacing distances from the previously detected path may be ignored. In order to recognize crop edges running at angles, all detected crop edges are stored in memory for a period of time so that the path of the vehicle along the crop edge can be recognized. If during operation around curves the boundary of the operation has reached beyond the measurement region of the laser scanning sensor, the angular scanning region of the laser scanning sensor can be oriented anew on the basis of the position detected. This is performed internally within the sensor by changing the position of lenses, transmitter and receiver and/or by rotating the entire sensor unit. [0013] By estimating the position of the boundary of operation the scanning angle of a laser scanning sensor can be reduced by the controller to a region where the boundary of operation is expected. Thereby higher scanning rates and better control response can be attained at higher forward propulsion velocities. Nevertheless during the narrowing of the scanning sensor region the quality (accuracy) of the available position data must also be considered. BRIEF DESCRIPTION OF THE DRAWINGS [0014] [0014]FIG. 1 shows an agricultural utility vehicle with an arrangement according to the invention for automatic steering. [0015] [0015]FIG. 2 shows a plan view of the utility vehicle during the harvesting of a field. [0016] [0016]FIG. 3 shows a flow chart according to which the controller operates. DETAILED DESCRIPTION [0017] The utility vehicle 10 , illustrated in FIG. 1, is an agricultural combine. The combine is supported on front driven and rear steerable wheels 12 and 14 , respectively, and is provided with an operator's cab 16 from which it is controlled by an operator. The present invention could also be used on other utility vehicles, such as, self propelled forage harvesters, self-propelled large balers and tractors having ground engaging implements or seeding machines. A grain tank 18 is located behind the operator's cab 16 . The grain tank 18 is used for temporarily storing clean grain until it is transferred to a grain cart or truck by unloading auger 20 . The grain tank 18 is supported on a frame 22 formed by two side sheets. The harvested crop is separated into its large and small components within the side sheets. The crop is first harvested by a harvesting assembly 64 (See FIG. 2) and from the harvesting assembly 64 the harvested crop is directed to a feeder house 38 . The feeder house 38 is an upwardly sloping conveyor which conveys the harvested crop past a stone trap 40 to a threshing assembly. The threshing assembly comprises a threshing cylinder 24 with associated concave 26 and a beater 28 . The threshed crop material is transferred to a separation assembly comprising straw walkers 30 which expand the threshed crop mat to release grain trapped in this mat. Clean grain and chaff falling from the concave 26 and the straw walkers 30 is directed to a grain pan 32 . Crop material other than grain is expelled over the rear of the straw walkers 30 and out of the combine. The grain pan 32 directs the clean grain and chaff to a cleaning assembly which comprises sieves 34 and a cleaning fan 36 . The cleaning fan 36 blows the chaff out the rear of the combine, whereas the clean grain falls downwardly and is collected on the floor of the combine. The clean grain is transferred upwardly by a clean grain elevator to the grain tank 18 . [0018] The roof of the operator's cab 16 is provided with a first position sensor 42 . The first position sensor is an antenna for the reception of GPS signals. Although this sensor is located on the roof of the operator's cab 16 , it may be located at any position on the combine where it would receive a good GPS signal. [0019] The front of the operator's cab 16 is provided with a second position sensor 44 . The second position sensor 44 has a transmitter for emitting laser radiation which reaches the ground approximately 10 meters ahead of the vehicle 10 . The laser radiation is reflected back from the ground or crop to the sensor 44 which is also provided with a receiver for receiving this reflected radiation. The distance to the reflection point from the sensor 44 is determined by the propagation time of the laser radiation to be received by the receiver. The second position sensor 44 is pivoted about an approximately vertical axis, in order to scan a region transverse to the direction of forward movement of the vehicle 10 . The signal of the receiver makes it possible to establish the angle between the forward operating direction and the position of the boundary of standing crop. Such position sensors 44 are known and are described, for example, in U.S. Pat. Nos. 6,095,254, and 6,101,795, whose disclosures are incorporated herein by reference. There is a possibility of using a laser distance sensor in which the transmitter and receiver are not rotated, but a mirror rotating step-by-step or continuously is used to scan the visible region. It can scan an angular region of up to 180°. Such sensors are available from Sick A. G., D-72796, Reute, under the designation LMS. [0020] The first position sensor 42 and the second position sensor 44 communicate over a bus with a controller 46 having a memory 48 . The controller 46 supplies a steering signal to a steering controller 50 . The steering controller 50 is used for controlling the steering angle of the rear steerable wheels 14 . [0021] [0021]FIG. 2 shows a plan view of the utility vehicle 10 during an agricultural harvesting operation. The harvesting assembly 64 is a harvesting platform, that cuts the plants (cereal crop) from the field. Numerical designator 68 characterizes the boundary of operation between the previously harvested proportion of the field and the plants 62 that are still to be harvested. This boundary of operation in this application is known as a crop edge. The angular region covered by the scanning sensor 44 is scanning region 66 . It can be seen that the right portion of the scanning region 66 overlaps the boundary of operation 68 . Furthermore, it can be seen that a time delay exists between the measurement of the position of the boundary of operation 68 and the point in time at which the vehicle 10 reaches the measurement point. This time delay must be considered in the providing a steering signal to the steering controller 50 . [0022] [0022]FIG. 3 is a flow chart illustrating the operation of the controller 46 . After the start in step 100 , step 102 follows in which the first position signal of the first position sensor 42 is received. The position signal transmitted by the position sensor 42 from the satellite antenna may exhibit differing degrees of accuracy depending on external conditions. Position sensor 42 may have a limited view of the sky and may not receive a sufficiently large number of GPS satellites or in the case DGPS may not receive the correction signals. Obstacles located in the vicinity of the utility vehicle such as buildings or trees create errors in the propagation time that can also reduce the accuracy. Therefore the first position sensor transmits signal quality information about the quality or the accuracy of the first position signal, that is derived from the number of GPS satellites received at that time and the amplitude (field strength) of the signals received by the first position sensor 42 . The first singal quality information transmitted to the controller 46 is therefore a measure of the accuracy or reliability of the first position signal. [0023] In the following step 104 , the controller 46 receives a second position signal from the second position sensor 44 . The second position signal contains distance information as well as the angle between the longitudinal centerline of the utility vehicle 10 and the crop edge at that time. Optical sensors for the recognizing crop edges of a windrow or standing crop may operate with less accuracy in dusty conditions, in fog, with lodged grain crop, and in very thin crop stands. In addition these sensor may have difficulty in finding the crop edge when operating around sharp curves, upon entry into a crop stand, upon reaching the end of the field, and for when several edges are encountered. In these cases the second position signal would not be as accurate and precise influencing the steering negatively. For this reason the controller 46 is supplied with a second signal quality information that is derived from the size of the change in the signal at the crop edge received by the receiver of the second position sensor 44 . The greater the change in the signal from the crop edge, the more precise the measurement of the angle will be by which the crop edge is located. [0024] In step 106 , the actual position of the utility vehicle 10 is calculated from the first position signal and the second position signal. The second position signal contains information about the position of the utility vehicle 10 relative to the crop edge, whose accuracy is in the centimeter range. Since the harvesting operation normally is performed along parallel tracks with an offset that is specific to the harvesting assembly, the crop edge can be calculated from previous crossings of the field, in which the position of the utility vehicle 10 was stored in memory 48 . On the basis of the position previously calculated of the crop edge and the position of the utility vehicle 10 relative to it, the second position signal can be utilized to improve the accuracy of the first position signal. The position of the utility vehicle 10 is determined by considering the direction and the velocity of the vehicle 10 as well as the distance required by the vehicle 10 to cover the time delayed location sensed by the second position sensor 44 . In this way the first position signal from the first position sensor 42 is compared with the time delayed second position signal of the second position sensor 44 . The controller 46 considered both position signals and the quality information associated with both position signals. The better the quality of one of the signals relative to the other signal, the more strongly it is considered and weighted in calculating the actual position of the utility vehicle 10 . [0025] In the next step 108 , the controller 46 evaluates the accuracy of the second position signal to determine if it is greater than a threshold value stored in memory 48 , that corresponds to an accuracy of a few centimeters. If the accuracy is sufficient, step 110 follows, in which a steering signal is generated, based on the second position signal, and is transmitted to the steering controller 50 . The steering signal is selected by the controller 46 on the basis of the second position signal or the position calculated in step 106 in such a way that the utility vehicle 10 is guided in a manner known in itself along the crop edge. The target path information stored in memory 48 corresponds to the intended path along the crop edge where, however, no map is stored in memory, but only the desired transverse distance between the longitudinal centerline of the utility vehicle 10 and the crop edge. In step 112 the controller 46 orders that the position information calculated in step 106 be stored in memory 48 . Step 112 is again followed by step 102 . [0026] If step 108 concludes that the accuracy of the second position signal is not adequate, step 114 follows, in which the position signal as was calculated in step 106 , whose accuracy can be improved in case the accuracy of the second position signal is inadequate or independent thereof can be improved by local sensors for the movement of the utility vehicle 10 , the steering angles and acceleration and possibly the inclination of the slope, and generates a steering signal from the path previously covered by the utility vehicle 10 that was recorded in the memory arrangement 48 , and supplies this to the steering controller 50 . Since the operation on the field is normally performed in parallel paths with an offset depending on the width of the crop recovery arrangement, the path of the utility vehicle 10 can be predicted on the basis of the position calculated in step 106 (as was recorded). The method of the designation of the target path (for example, by a map, on the basis of the boundary of the operation or the previous path) may also be provided as input by the operator, in addition to the automatic selection. Step 114 is followed by step 112 . [0027] Having described the preferred embodiment, it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is based upon and claims the benefit of priority from prior Japanese Patent Application No. P2004-208125, filed on Jul. 15, 2004, the entire contents of which are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to an ultrasound diagnosis apparatus including a main unit and an ultrasound probe, which is connectable to the main unit. [0004] 2. Discussion of the Background [0005] Ultrasound diagnosis apparatuses are generally used in a medical field. An ultrasound diagnosis apparatus transmits ultrasound signals from its ultrasound probe towards a patient and receives echo signals resulting from the ultrasound signals from the patient so that ultrasound image data can be prepared based on the echo signals. Doctors diagnose ultrasound images displayed based on the ultrasound image data with respect to the patient. There are many types of ultrasound probes according to diagnostic purposes, such as, for example, which part to diagnose and in what condition the patient is. One of the ultrasound probes which is appropriate for a specific purpose may selectively be used by switching the ultrasound probes connected to a main unit of the ultrasound diagnosis apparatus. Each ultrasound probe is detachable from the main unit through connectors. For example, when three ultrasound probes are connected to the main unit, one desired from the three ultrasound probes is made usable by the doctor's operating one or more switches provided in the main unit. [0006] An ultrasound probe electrically connected to the main unit may be called an active ultrasound probe. An ultrasound probe which is not electrically connected to the main unit but ready for use may be called a standby ultrasound probe. An ultrasound probe which may not be used relatively so often can be the standby ultrasound probe and be replaced with the active ultrasound probe, if necessary. [0007] FIG. 1A is an illustration showing a front view of the first conventional ultrasound diagnosis apparatus. FIG. 1B is an illustration showing a side view of the first conventional ultrasound diagnosis apparatus. Similarly, FIG. 2A is an illustration showing a front view of the second conventional ultrasound diagnosis apparatus. FIG. 2B is an illustration showing a side view of the second conventional ultrasound diagnosis apparatus. The difference between the first and second conventional ultrasound diagnosis apparatuses is an arrangement of connectors for ultrasound probes as will be described below. [0008] An ultrasound diagnosis apparatus 1 includes casters 2 , a main unit 3 , an ultrasound probe 4 (shown in FIG. 3 ), an operation panel 5 , a display unit 6 , and a cable hanger 7 . The main unit 3 is allowed to move with the casters 2 . The main unit 3 receives echo signals from the ultrasound probe 4 and processes the echo signals so as to obtain ultrasound images. The main unit 3 has a plurality of main unit connector 3 a (e.g. three main unit connectors 3 a ) along a horizontal direction of the main unit 3 as shown in FIGS. 1A and 1B or along a vertical direction of the main unit 3 as shown in FIGS. 2A and 2B . The three main unit connectors 3 a are electrically connected to a circuitry board provided in the main unit 3 . There is a plurality of the ultrasound probe 4 (e.g. three ultrasound probes 4 ). When the three ultrasound probes 4 are connected to the three main unit connectors 3 a, one of the three ultrasound probes 4 can selectively be activated through the circuitry board and one of the main unit connectors 3 a. [0009] Each ultrasound probe 4 can be used to transmit ultrasound signals and receive echo signals resulting from the ultrasound signals. As shown in FIG. 3 , the ultrasound probe 4 includes an ultrasound probe head 4 a, an ultrasound probe connector 4 b, a cable 4 c, a connector fixing tab 4 d, and a connection pin 4 e. The ultrasound probe head 4 a includes a plurality of ultrasound transducers to transmit ultrasound signals (or ultrasound pulses). The ultrasound transducers are also used to receive echo signals resulting from the ultrasound signals. The ultrasound probe head 4 a is connected to the ultrasound probe connector 4 b through the cable 4 c. The ultrasound probe connector 4 b can be connected to the main unit connector 3 a provided in the main unit 3 when the ultrasound probe 4 is used as an active ultrasound probe. The connector fixing tab 4 d is used to fix the ultrasound probe connector 4 b to the main unit connector 3 a when the ultrasound probe connector 4 b is connected to the main unit connector 3 a. The connection pin 4 e is inserted into a connection hole provided in the main unit connector 3 a when the ultrasound probe connector 4 b is connected to the main unit connector 3 a. [0010] The operation panel 5 is provided at the upper part of the main unit 3 and used to input information, instructions, and the like. The operation panel 5 has a probe head holder 5 a to hold the ultrasound probe head 4 a. The display unit 6 is provided on the top of the main unit 3 and used to display ultrasound images. The cable hanger 7 is provided to hang a part of the cable 4 c at a higher position than the probe head holder 5 a. The cable hanger 7 can be inflected or bended so as to hang the cable 4 c at a desired height. In FIGS. 1A to 2 B, the cable hanger 7 hangs the cables 4 c of the three ultrasound probes 4 . There may be one or more standby ultrasound probes which may be placed at other position than the ultrasound diagnosis apparatus 1 . [0011] Another ultrasound diagnosis apparatus has been introduced as described in Japanese patent application publication No. 2003-339702 which may correspond to U.S. patent application publication No. 2003/0217600. In this ultrasound diagnosis apparatus, a main unit connector to be connected to an ultrasound probe connector is provided at a position between a main unit and a display unit. [0012] The conventional ultrasound diagnosis apparatuses have the following problems or defects. [0013] The ultrasound diagnosis apparatus has been required to improve image resolution. To meet this requirement, the ultrasound probe head 4 a has more and more channels, that is, a number of ultrasound transducers provided in the ultrasound probe head 4 a including, for example, piezoelectric transducers. The number of channels affects the number of signal pins provided at a face of the ultrasound probe head 4 a where the ultrasound probe connector 4 b is connected to the main unit connector 3 a. Therefore, the more the number of channels increases, the larger the ultrasound probe head 4 a becomes. Further, a three-dimensional ultrasound scan has been introduced recently, which is accomplished by an ultrasound probe having ultrasound transducers two-dimensionally arrayed at an ultrasound probe head. In such an ultrasound probe, the number of channels significantly increases, compared to an ultrasound probe including one-dimensionally arrayed ultrasound transducers. Therefore, the ultrasound probe connector becomes larger and a cable connected to the ultrasound probe connector becomes thicker. [0014] Meanwhile, the main unit 3 has recently been required to be more compact and lighter-weight so as to be easily moved and to occupy less space. This requirement limits the number of main unit connectors 3 a and flexibility of a layout of the main unit connectors 3 a. Particularly, this is a problem when the ultrasound probe 4 has a larger size of the ultrasound probe connector 4 b. In other words, it is hard to make the main unit 3 compact if the desired number of ultrasound probe connectors 3 a are provided in the main unit 3 and/or the ultrasound probe head 4 a has more channels. [0015] Further, when the standby ultrasound probe is placed at other position than the ultrasound diagnosis apparatus 1 , it is not easy to immediately replace the active ultrasound probe with the standby ultrasound probe, which results in a waste of time in an ultrasound imaging examination. [0016] When the ultrasound probe connectors 4 b are connected to the main unit connectors 3 a as shown in FIGS. 1A and 2A , the cables 4 c may be lead out from the ultrasound probe connectors 4 b to be pulled towards the cable hanger 7 at about right angle particularly when the cables 4 c are thick and rigid like the ultrasound probe including the two-dimensionally arrayed ultrasound transducers. Alternatively, the cables 4 c may sag a little and be pulled towards the cable hanger 7 . In either way, the cables 4 c are given a strong effort in the vicinity of the ultrasound probe connectors 4 b, which may lead to a wire break in the cables 4 c. Particularly, when the cables 4 c are thick and rigid, the moment of force given to the cables 4 c in the vicinity of the ultrasound probe connectors 4 b may become too large so that the cables 4 c may be damaged. In addition, when the doctor brings the ultrasound probe connector 4 b so as to connect it to the main unit connector 3 a, the strong tension of the cable 4 is effected to the doctor's hand and arm. This may result in deteriorating the operationality of connecting the ultrasound probe connector 4 b. [0017] Still further, when the circuitry board is provided in parallel with the three main unit connectors 3 a, the signal transmission distance between the circuitry board and the ultrasound probe connector 4 b connected to the main unit connector 3 a differs among the main unit connectors 3 a. This may cause the echo signals received from the ultrasound probe 4 to be different in their characteristics. [0018] Further, the circuitry board is typically provided in the middle of or in the lower part of the main unit 3 . Therefore, when it is the ultrasound diagnosis apparatus described in the above-mentioned Japanese patent application publication, the signal transmission distance between the circuitry board and the main unit connector is so long that noise signals may be generated in the echo signals received from the ultrasound probe 4 and deteriorate ultrasound image quality. In addition, since the main unit connector is provided at a rather high position of the ultrasound diagnosis apparatus, dragging about the cable may disturb the doctor's operation of the ultrasound diagnosis apparatus. SUMMARY OF THE INVENTION [0019] According to the first aspect of the present invention, there is provided an ultrasound diagnosis apparatus including an ultrasound probe and a main unit. The ultrasound probe includes a cable, a probe head coupled to one end of the cable, and a connector coupled to the other end of the cable. The probe head has an ultrasound transducer. The ultrasound probe is configured to transmit an ultrasound signal and receive an echo signal resulting from the ultrasound signal. The main unit has a concave portion into which the connector is inserted. The main unit is configured to receive the echo signal from the ultrasound probe and to process the echo signal so as to obtain an ultrasound image. The concave portion is slanted on a side surface of the main unit. [0020] According to the second aspect of the present invention, there is provided an ultrasound diagnosis apparatus including an ultrasound probe and a main unit. The ultrasound probe includes a cable, a probe head coupled to one end of the cable, and a connector coupled to the other end of the cable. The probe head has an ultrasound transducer. The ultrasound probe is configured to transmit an ultrasound signal and receive an echo signal resulting from the ultrasound signal. T main unit has a concave portion into which the connector is inserted. The main unit is configured to receive the echo signal from the ultrasound probe and to process the echo signal so as to obtain an ultrasound image. One end of the concave portion is shallower than an opposite end of the concave portion. [0021] According to the third aspect of the present invention, there is provided an ultrasound diagnosis apparatus including an ultrasound probe and a main unit. The ultrasound probe includes a cable, a probe head coupled to one end of the cable, and a connector coupled to the other end of the cable. The probe head has an ultrasound transducer. The ultrasound probe is configured to transmit an ultrasound signal and receive an echo signal resulting from the ultrasound signal. The main unit has a concave portion into which the connector is inserted. The main unit is configured to receive the echo signal from the ultrasound probe and to process the echo signal so as to obtain an ultrasound image. The concave portion is provided so that the other end of the cable is lead out from the connector at an upward angle with respect to a horizontal direction when the connector is inserted in the concave portion. BRIEF DESCRIPTION OF THE DRAWINGS [0022] A more complete appreciation of embodiments of the present invention and many of its attendant advantages will be readily obtained by reference to the following detailed description considered in connection with the accompanying drawings, in which: [0023] FIG. 1A is an illustration showing a front view of the first conventional ultrasound diagnosis apparatus; [0024] FIG. 1B is an illustration showing a side view of the first conventional ultrasound diagnosis apparatus; [0025] FIG. 2A is an illustration showing a front view of the second conventional ultrasound diagnosis apparatus; [0026] FIG. 2B is an illustration showing a side view of the second conventional ultrasound diagnosis apparatus; [0027] FIG. 3 is an illustration showing an example of a conventional ultrasound probe; [0028] FIG. 4A is an illustration showing an exemplary front view of an ultrasound diagnosis apparatus according to the first embodiment; [0029] FIG. 4B is an illustration showing an exemplary side view of the ultrasound diagnosis apparatus according to the first embodiment; [0030] FIG. 5A is an illustration showing an exemplary front view of a main unit of the ultrasound diagnosis apparatus according to the first embodiment; [0031] FIG. 5B is an illustration showing an exemplary cross-sectional view of the main unit along a line A-A; [0032] FIG. 5C is an illustration showing an exemplary cross-sectional view of the main unit along a line B-B; [0033] FIG. 5D is an illustration showing an exemplary cross-sectional view of the main unit along a line B-B when an ultrasound probe is inserted in the main unit; [0034] FIG. 5E is an illustration showing an exemplary cross-sectional view of the main unit along a line C-C; [0035] FIG. 5F is an illustration showing an exemplary cross-sectional view of the main unit along the line C-C when an ultrasound probe is inserted in the main unit; [0036] FIG. 6A is an illustration showing another exemplary cross-sectional view of the main unit along the line A-A; [0037] FIG. 6B is an illustration showing another exemplary cross-sectional view of the main unit along the line B-B; [0038] FIG. 6C is an illustration showing another exemplary cross-sectional view of the main unit along the line B-B when the ultrasound probe is inserted in the main unit; [0039] FIG. 6D is an illustration showing another exemplary cross-sectional view of the main unit along the line C-C; [0040] FIG. 6E is an illustration showing another exemplary cross-sectional view of the main unit along the line C-C when the ultrasound probe is inserted in the main unit; [0041] FIG. 7A is an illustration showing an exemplary front view of the ultrasound diagnosis apparatus according to the second embodiment; [0042] FIG. 7B is an illustration showing an exemplary side view of the ultrasound diagnosis apparatus according to the second embodiment; [0043] FIG. 8A is an illustration showing an exemplary cross-sectional view of the main unit along the line C-C according to the second embodiment; [0044] FIG. 8B is an illustration showing an exemplary cross-sectional view of the main unit along the line C-C when an ultrasound probe is inserted in the main unit according to the second embodiment; [0045] FIG. 8C is an illustration showing an exemplary side view of the main unit according to the second embodiment; [0046] FIG. 9A is an illustration showing an exemplary front view of the main unit according to the third embodiment; [0047] FIG. 9B is an illustration showing an exemplary cross-sectional view of the main unit along a line A-A; [0048] FIG. 9C is an illustration showing an exemplary cross-sectional view of the main unit along a line B-B; [0049] FIG. 9D is an illustration showing an exemplary cross-sectional view of the main unit along the line B-B when an ultrasound probe is inserted in the main unit; [0050] FIG. 9E is an illustration showing an exemplary cross-sectional view of the main unit along a line C-C; [0051] FIG. 9F is an illustration showing an exemplary cross-sectional view of the main unit along the line C-C when an ultrasound probe is inserted in the main unit; [0052] FIG. 10A is an illustration showing an exemplary front view of the ultrasound diagnosis apparatus according to the fourth embodiment; [0053] FIG. 10B is an illustration showing an exemplary side view of the ultrasound diagnosis apparatus according to the fourth embodiment; and [0054] FIG. 11 is an illustration showing an exemplary front view of the main unit according to the fifth embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0055] Embodiments of the present invention will be described with reference to the accompanying drawings. The reference numbers used in FIGS. 1 to 3 are still used to show similar components shown in the drawings to be referred to in the following description. Detailed explanation will be omitted for such components. First Embodiment [0056] FIG. 4A is an illustration showing an exemplary front view of an ultrasound diagnosis apparatus according to the first embodiment. Also, FIG. 4B is an illustration showing an exemplary side view of the ultrasound diagnosis apparatus according to the first embodiment. As shown in FIG. 4A , three ultrasound probes 4 b may be placed as active ultrasound probes and two ultrasound probes 4 as standby ultrasound probes on the front face of the main unit 3 while the main unit 3 is still kept compact in size. [0057] The main unit 3 has, for example, three main unit connectors 30 as an example of ‘concave portion’ below the operation panel 5 . The number of the main unit connectors 30 is not limited to three. The main unit connectors 30 are connected to a circuitry board provided in the main unit 3 and can be connected to active ultrasound probes. The main unit connectors 30 may be provided on the right side of the front face of the main unit 3 . [0058] The main unit connectors 30 are slanted on the front face of the main unit 3 towards an upper right direction of the main unit 3 at a predetermined angle. The angle may preferably be around thirty degrees with respect to the horizontal direction. This is because it may become easy for the doctor to connect and disconnect the ultrasound probe 4 to and from the main unit 3 without unreasonable strain on a wrist of the doctor. In other words, the doctor may easily be able to insert the ultrasound probe connector 4 b into the main unit connector 30 and pull it out of the main unit connector 30 without much stress on the wrist. In addition, it is possible to avoid the cable 4 c from being given a strong effort in the vicinity of the ultrasound probe connectors 4 b and being damaged. The cable 4 c may be pulled towards the cable hanger 7 along one of side surfaces of the main unit 3 . The above-mentioned angle may be determined, considering the insertion direction of the ultrasound probe connector 4 b and/or the direction of the cable 4 c led out from the ultrasound probe connector 4 b. The three main unit connectors 30 may be arranged in parallel with one another so as not to unnecessarily occupy a wide space of the front face of the main unit 3 . [0059] After the ultrasound probe connector 4 b has been inserted in the main unit connector 30 , the connector fixing tab 4 d is winded to fix the ultrasound probe connector 4 b to the main unit connector 30 so that the ultrasound probe 4 is fixed to the main unit 3 . The ultrasound probe head 4 a is held by the probe head holder 5 a which is provided on the right side of the operation panel 5 . The ultrasound probe head 4 a is omitted in FIG. 4A to avoid the complication of the drawing. [0060] As shown in FIG. 4A , the main unit 3 also has, for example, two holders 31 as another example of ‘concave portion’ below the operation panel 5 . The number of the holders 31 is not limited to two. The holders 31 are not connected to the circuitry board and can be connected to standby ultrasound probes. The holders 31 may be vertically provided on the left side of the main unit 3 along the horizontal direction. A connection surface of the holder 31 where a connection hole to insert the connection pin 4 e is provided is slanted towards the upper inside of the main unit 3 at a predetermined angle. The angle may preferably be around fifteen degrees with respect to the vertical direction. This is because it may become easy for the doctor to place the ultrasound probe connector 4 b to the holder 31 and detach it from the holder 31 . In addition, it is possible to avoid the cable 4 c from being given a strong effort in the vicinity of the ultrasound probe connectors 4 b and being damaged. The above-mentioned angle may be determined, considering the placing direction of the ultrasound probe connector 4 b and/or the direction of the cable 4 c led out from the ultrasound probe connector 4 b. The two holders 31 may be arranged in parallel with each other so as not to unnecessarily occupy a wide space of the front face of the main unit 3 . [0061] After the ultrasound probe connector 4 b has been placed to the holder 31 , the connector fixing tab 4 d is winded to fix the ultrasound probe connector 4 b to the holder 31 so that the ultrasound probe 4 is fixed to the main unit 3 . Since the holder 31 is not connected to the circuitry board, the fixation is not for the electrical connection but for the physical connection to avoid the ultrasound probe connector 4 b from falling down from the holder 31 . The ultrasound probe head 4 a of the standby ultrasound probe may also be held by another probe head holder which can be provided, for example, on the left side of the operation panel 5 . Accordingly, the use of the holders 31 (and another probe head holder) can make it possible to hold the standby ultrasound probes with the ultrasound diagnosis apparatus 1 . This is helpful for the doctor to use the standby ultrasound probe by immediately replacing the active ultrasound probe with the standby ultrasound probe. The doctor pulls out the ultrasound probe connector 4 b of the active ultrasound probe from the main unit connector 30 and also detaches the ultrasound probe connector 4 b of the standby ultrasound probe from the holder 31 . Then, the doctor can insert the ultrasound probe connector 4 b of the standby ultrasound probe into the main unit connector 30 so as to use it as a new active ultrasound probe. [0062] Details of the main unit connectors 30 , the holders 31 , and their modified examples will be described with reference to FIGS. 5A to 6 E. FIG. 5A is an illustration showing an exemplary front view of the main unit 3 . As shown in FIG. 5A , the main unit connectors 30 and the holders 31 are provided in the main unit 3 . Exemplary cross-sectional views of the main unit 3 along lines A-A and B-B are shown in FIGS. 5B and 5C , respectively. The depth of each main unit connector 30 is even and each main unit connector 30 has a concave shape. The main unit connectors 30 are connected to a circuitry board 50 through electric wires 51 . When an ultrasound probe connector 4 b is inserted in the main unit connector 30 , the ultrasound probe connector 4 b is connected to the electric wires 51 as shown in FIG. 5D . [0063] An exemplary cross-sectional view of the main unit 3 along a line C-C is shown in FIG. 5E . The depth of each holder 31 is not even since the connection surface of the holder 31 where a connection hole 52 to insert the connection pin 4 e is provided is slanted towards the upper inside of the main unit 3 at a predetermined angle. The holders 31 are not connected to the circuitry board 50 . When an ultrasound probe connector 4 b is inserted in the holder 31 , the ultrasound probe connector 4 b is not connected to the circuitry board 50 as shown in FIG. 5F . [0064] Modified examples of the main unit connectors 30 and the holders 31 are shown as main unit connectors 32 and holders 33 . Exemplary cross-sectional views of the main unit 3 along lines A-A and B-B in FIG. 5A are shown in FIGS. 6A and 6B , respectively. The depth of each main unit connector 32 is not even since a connection surface of the main unit connector 32 where a connection hole 53 to insert the connection pin 4 e is provided is slanted towards the upper inside of the main unit 3 at a predetermined angle. The main unit connectors 32 are connected to the circuitry board 50 through the electric wires 51 . When an ultrasound probe connector 4 b is inserted in the main unit connector 32 , the ultrasound probe connector 4 b is connected to the electric wires 51 as shown in FIG. 6C . [0065] An exemplary cross-sectional view of the main unit 3 along the line C-C in FIG. 5A is shown in FIG. 6D . The depth of each holder 33 is even and each holder 33 has a concave shape. The holders 33 are not connected to the circuitry board 50 . When an ultrasound probe connector 4 b is inserted in the holder 33 , the ultrasound probe connector 4 b is not connected to the circuitry board 50 as shown in FIG. 6E . In FIG. 6E , the connector fixing tab 4 d may not be used to fix the ultrasound probe connector 4 b to the holder 33 if the depth of the holder 33 is deep enough to support the ultrasound probe connector 4 b. Second Embodiment [0066] FIG. 7A is an illustration showing an exemplary front view of the ultrasound diagnosis apparatus 1 according to the second embodiment. Also, FIG. 7B is an illustration showing an exemplary side view of the ultrasound diagnosis apparatus 1 according to the second embodiment. The difference between the first and second embodiments is that the main unit 3 as shown in FIG. 7B has supporters 70 each of which for supporting at least a part of the ultrasound probe connector 4 b when the ultrasound probe connector 4 b is inserted in the holder 31 . Components similar to those shown in FIGS. 4A and 4B are given the same reference numbers and the detailed explanation of such components is omitted herein although the ultrasound probe head 4 a and the cable 4 c are omitted and not shown in FIGS. 7A and 7B . [0067] Details of the holder 31 will be described with reference to FIGS. 8A to 8 D. An exemplary cross-sectional view of the main unit 3 along the line C-C in FIG. 5A is shown in FIG. BA. The supporter 70 is provided at positions corresponding to the bottom and sides of the holder 31 so that the ultrasound probe connector 4 b can be supported by the supporter 70 when the ultrasound probe connector 4 b is inserted in the holder 31 as shown in FIG. 8B . FIG. 8C is an illustration showing an exemplary side view of the main unit 3 according to the second embodiment. The supporter 70 may be more clearly understood by referring to FIG. 8C . The supporter 70 is extended away from the front face of the main unit 3 so as to support the bottom and sides of the ultrasound probe connector 4 b. In FIG. 8C , the supporter 70 may support only a part of each side of the ultrasound probe connector 4 b. The supporter 70 , however, may support a whole surface of either or both of the sides of the ultrasound probe connector 4 b. [0068] According to the second embodiment, it may not be necessary to fix the ultrasound probe connector 4 b to the holder 31 with the connector fixing tab 4 d since the ultrasound probe connector 4 b is supported by the supporter 70 . Therefore, it may be possible to avoid the ultrasound probe connector 4 b from falling down from the holder 31 without fixing with the connector fixing tab 4 d even if the ultrasound diagnosis apparatus 1 is vibrated for some sort of reasons, for example, traveling of the ultrasound diagnosis apparatus 1 . The position where the supporter 70 is provided and the shape of the supporter 70 are not limited to those shown in FIGS. 8 A to 8 C. Third Embodiment [0069] In the first embodiment, the slanted main unit connectors 30 have been used to electrically connect the ultrasound probe connector 4 b to the circuitry board 50 while the vertically-provided holders 31 have not been connected to the circuitry board 50 . The third embodiment will describe the opposite case to the first embodiment. That is, as shown in FIG. 9A , the slanted main unit connectors 30 are replaced with holders 34 which are slanted on the front face of the main unit 3 towards an upper right direction of the main unit 3 at a predetermined angle while the vertically-provided holders 31 are replaced with main unit connectors 35 which are vertically provided on the front face of the main unit 3 . [0070] Details of the holders 34 and the main unit connectors 35 will be described with reference to FIGS. 9B to 9 E. Exemplary cross-sectional views of the main unit 3 along the lines A-A and B-B are shown in FIGS. 9B and 9C , respectively. The depth of each holder 34 is even and each holder 34 has a concave shape. Here, the holders 34 are not connected to the circuitry board 50 . When an ultrasound probe connector 4 b is inserted in the holder 34 , the ultrasound probe connector 4 b is not connected to the circuitry board 50 as shown in FIG. 9 D. [0071] An exemplary cross-sectional view of the main unit 3 along the line C-C is shown in FIG. 9E . The depth of each main unit connector 35 is not even since the connection surface of the main unit connector 35 where a connection hole 54 to insert the connection pin 4 e is provided is slanted towards the upper inside of the main unit 3 at a predetermined angle. The main unit connectors 35 are connected to the circuitry board 50 through electric wires 55 . When an ultrasound probe connector 4 b is inserted in the main unit connector 35 , the ultrasound probe connector 4 b is connected to the electric wires 55 as shown in FIG. 9F . Fourth Embodiment [0072] The fourth embodiment will be described with reference to FIGS. 10A and 10B . FIG. 10A is an illustration showing an exemplary front view of the ultrasound diagnosis apparatus 1 according to the fourth embodiment. Also, FIG. 10B is an illustration showing an exemplary side view of the ultrasound diagnosis apparatus 1 according to the fourth embodiment. The difference between the first and fourth embodiments is that the main unit 3 has main unit connectors 36 instead of the main unit connectors 3 . The main unit connectors 36 are slanted on the front face of the main unit 3 towards an upper right direction of the main unit 3 at a predetermined angle. The angle may preferably be around thirty degrees with respect to the horizontal direction. Accordingly, the doctor may easily be able to insert the ultrasound probe connector 4 b into the main unit connector 36 and pull it out of the main unit connector 36 without much stress on the wrist. In addition, it is possible to avoid the cable 4 c from being given a strong effort in the vicinity of the ultrasound probe connectors 4 b and being damaged. The cable 4 c may be pulled towards the cable hanger 7 along one or more side surfaces of the main unit 3 . The above-mentioned angle may be determined, considering the insertion direction of the ultrasound probe connector 4 b and/or the direction of the cable 4 c led out from the ultrasound probe connector 4 b. The main unit connectors 36 may be provided along the horizontal direction and arranged in parallel with one another so as not to unnecessarily occupy a wide space of the front face of the main unit 3 . [0073] Components similar to those shown in FIGS. 4A and 4B are given the same reference numbers and the detailed explanation of such components is omitted herein. The number of the main unit connectors 30 is not limited to three. In FIG. 10A , the main unit 3 does not have any holder. If necessary, one or more holders may be provided under the arrangement of the main unit connectors 36 . Fifth Embodiment [0074] FIG. 11 is an illustration showing an exemplary front view of the main unit 3 according to the fifth embodiment. The main unit 3 has main unit connectors 37 to 39 . As understood from FIG. 11 , the main unit connectors 37 to 39 are not arranged in parallel with one another but at a different angle relative to each of the main unit connectors 37 to 39 . Particularly, the main unit connector 37 provided closer to the top of the main unit 3 is less slanted on the front face of the main unit 3 towards an upper right direction of the main unit 3 , compared to the main unit connectors 38 and 39 while the main unit connector 39 provided closer to the bottom of the main unit 3 is more slanted on the front face of the main unit 3 towards an upper right direction of the main unit 3 , compared to the main unit connectors 37 and 38 . [0075] This type of layout may require more space on the front face of the main unit 3 than the parallel layout and so may be implemented when the main unit 3 is not required to be so compact. This layout may make it easier for the doctor to insert the ultrasound probe connector 4 b into the main unit connectors 37 to 39 and pull it out of the main unit connectors 37 to 39 . [0076] Any combination of two or more of the main unit connectors 30 , 32 , 35 to 39 and the holders 31 , 33 , and 34 may be made as another embodiment or modification of the embodiments according to the necessity. [0077] The side surface of the main unit 3 where the main unit connectors and the holders are provided is not limited to the front face but may alternatively be other side surface of the main unit 3 such as, for example, a lateral face of the main unit 3 . Further, the main unit connectors and the holders may be provided in a plurality of side surface of the main unit 3 . [0078] The main unit connectors may alternatively be slanted towards an upper left direction of the main unit 3 at a predetermined angle, if necessary. [0079] The embodiments of the present invention described above are examples described only for making it easier to understand the present invention, and are not described for the limitation of the present invention. Consequently, each component and element disclosed in the embodiments of the present invention may be redesigned or modified to its equivalent within a scope of the present invention. Furthermore, any possible combination of such components and elements may be included in a scope of the present invention as long as an advantage similar to those obtained according to the above disclosure in the embodiments of the present invention is obtained. [0080] Numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

1a

CROSS REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of U.S. provisional patent application Ser. No. 61/494,317 filed Jun. 7, 2011 and U.S. provisional patent application Ser. No. 61/562,957 filed Nov. 22, 2011, both of which are hereby incorporated by reference in their entirety as if fully set forth herein. RELEVANT FIELD The systems and methods disclosed herein relate generally to portable drug delivery and sampling devices having impedance pumps. BACKGROUND For many diseases, treatment with oral or parenteral medicament administration requires a high dose which would lead to side effects that would inhibit a therapeutic concentration of the medicament from reaching diseased tissue. Thus, for such diseases, local medicament delivery to the diseased tissue is a desirable objective. It can provide higher concentrations of the medicament to the diseased tissue and allow control of the amount, rate and timing of delivery, which makes local delivery an option for long-term continuous treatment and potentially reduces systemic side effects. However, for some anatomical structures, such as the inner ear, local medicament delivery has special challenges due to, for example, limited natural points of entry, complex structures, barriers, and delicate environments. Known delivery modalities, e.g., systemic, intratympanic, etc., have not adequately or effectively addressed these challenges. Therefore, there is a need for a medicament delivery system that can provide localized delivery of a medicament. SUMMARY Described herein are systems, devices, and methods for the delivery of substances to, or the sampling of substances from, a patient using a portable and preferably implantable device. The substances introduced to and/or taken from the patient are preferably fluidic and are driven by a miniature pump, such as a microimpedance pump. A number of design variations are explicitly and implicitly described, such as the use of multiple pumps and multiple reservoirs for containing medicaments. Methods of manufacture of these systems and devices are also described, for instance, using molding, micromachining, or lithographic processes. Other systems, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments in this summary section, or in the following description sections, be construed as limiting the appended claims, absent express recitation of those features in the claims. BRIEF DESCRIPTION OF FIGURES The details of the systems, devices, and methods described herein, both as to their structure and operation, can be gleaned in part by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating principles. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. FIG. 1 is a schematic view depicting an example embodiment of a medicament delivery system. FIGS. 2A-F are cross-sectional views depicting an example method of manufacture of a medicament delivery system. FIGS. 2G-H are schematic views depicting an example method of securing inlet and/or outlet tubes to the delivery system substrate. FIGS. 3A-E are cross-sectional views depicting example flow distributions for medicament exiting a medicament delivery system. FIGS. 4A-B depict another example embodiment of a medicament delivery system. DETAILED DESCRIPTION The detailed description set forth below in connection with the appended drawings is intended to describe various example embodiments and is not intended to represent the only embodiments that may be practiced. In the following section, numerous examples and example embodiments are described. These embodiments are not described as rigid alternatives, but are rather intended to illustrate the broad scope and interchangeability of the systems, devices, and methods described herein. Thus, any feature, element, step, or aspect of one embodiment can be added to or substituted within any other embodiment described herein. An example embodiment of a medicament delivery system 10 is shown in FIG. 1 . Generally, the delivery system 10 is intended to be used to deliver a medicament into the inner ear for the treatment of inner ear and/or vestibular system disorders (e.g., tinnitus, SNHL, presbycusis, meniere's disease, etc.). While the embodiments described herein will be done so generally with regard to inner ear delivery, it should be understood that these embodiments can be used to deliver substances to any desired tissue or anatomical structure, including but not limited to intrathecal delivery (e.g., for pain management) and intraocular delivery. Likewise, the delivery system can be used to deliver any desired substance, drug, medicament, or therapeutic, including but not limited to cancer therapeutics and insulin. In the example embodiment of FIG. 1 , the delivery system 10 can be implanted in the mastoid portion of the temporal bone. In an example implantation procedure, a pocket can be formed in the mastoid bone for insertion of the delivery system 10 . Holes can be drilled to provide access to the scala tympani for the delivery system 10 . In another example embodiment, the delivery system 10 can be implanted using a postauricular mastoidomy or posterior tympanotomy. The delivery system 10 can also be configured to lie outside the body and deliver a substance through a catheter or subcutaneously through a needle. Alternatively, the delivery system 10 can lie outside the body and sample body fluids through a catheter or subcutaneously through a needle. In yet another example, the delivery system 10 can lie outside the body and deliver or sample substances through the dermis. The delivery system 10 includes a substrate (or body) 12 , pump 16 and tubing that can be manufactured from biocompatible polymeric materials (including, but not limited to, silicone, PDMS, PEEK, PTFE and Polysulfone (PSU), other fluoropolymers, PVDF, parylene, polyurethane, polysulphone, polyolefin, polyvinyl chloride, polypropylene, polycarbonate, and PMMA), metallic materials (including, but not limited to, nickel, titanium, and any alloys thereof (e.g., Ti6Al4V), stainless steel, and chromium), ceramics (including, but not limited to, zirconia and alumina), or combinations of the same. In an example embodiment, the substrate 12 can include a pump chamber 14 which houses a pump 16 for circulating fluid through the delivery system 10 . Pump 16 preferably utilizes a mismatch in impedance to drive flow and can be embodied by a compressible section or movable wall coupled at either end to wave reflection sites or locations where pressure wave energy is reflected. Here, pump 16 is an impedance pump enclosed within substrate 12 . Pump 16 can be manufactured from one or more materials and can assume any desired shape. In this example, pump 16 is made from silicon and is rectangular. In embodiments where pump 16 is manufactured from two or more materials, the first material can have a first impedance and the second material can have a second impedance, different from the first. Of course, any number of materials having different impedances can be used. Further examples of pump 16 can be, but are not limited to, those pump configurations and geometries described in U.S. Pat. Nos. 6,254,355, 6,679,687, 7,387,500, 7,163,385 and U.S. Patent Application Publication Nos. 2007/0177997 and 2011/0125136. Every patent and published application in the preceding sentence is expressly incorporated herein by reference for all purposes. Here, pump 16 has a longitudinal axis L and a transverse (or lateral) axis T. An activation element 18 (e.g., a magnet) can be disposed on a surface of substrate 12 , preferably a surface of a thin wall or membrane opposite pump chamber 14 . Activation element 18 is adapted to activate and/or instigate the mechanism that causes the pumping action, which in this embodiment is the movement of the thin wall underlying element 18 . Activation element 18 can be a piezoelectric, electromagnetic, or magnetostrictive device, to name a few. Activation element 18 preferably interfaces with a control device, which can also be a portable (e.g., wearable, implantable, or handheld) device located in proximity with delivery system 10 . The control device (not shown) can generate a permanent or variable magnetic field that interfaces with, e.g., a magnetic activation element 18 and causes that activation element to move. The control device is preferably programmable and adjustable based on user input. In one example embodiment, the control device has on-board electronics such as power management, frequency synthesizer, controller, communication links, and a battery. The device 10 itself may be implanted subcutaneously or worn externally with the drug perfusion tubing extending into the patient. In another example embodiment, the device functions as an in hospital delivery platform for drug perfusion through a venous or arterial catheter placed in the patient. In another embodiment device 10 functions in combination with a cochlear implant providing both stimulation and therapeutic treatments. In the instance where the geometry of the ends of channels 20 , 24 leading into pump chamber 14 are the same, then magnet 18 is preferably disposed at a position longitudinally offset from the central transverse axis T of pump chamber 14 . This asymmetry leads to the addition of pressure waves within chamber 14 that in turn creates the pumping effect (see, e.g., the incorporated U.S. Pat. No. 7,163,385). The geometry of the ends of channels 20 , 24 leading into pump chamber 14 can also be different, sized in the appropriate manner to allow activation element 18 to be centrally placed along axis T. A first channel 20 is disposed in substrate 12 and has a first opening 51 in fluid communication with pump 16 and a second opening 52 in fluid communication with an inlet tube 22 . Here, openings 51 and 52 are also located at opposite terminal ends of channel 20 . A second channel 24 is disposed in substrate 12 and has a first opening 53 in fluid communication with pump 16 (at an end of pump 16 opposite opening 51 of first channel 20 ) and a second opening 54 disposed in fluid communication with an outlet tube 26 . Here, openings 53 and 54 are also located at opposite terminal ends of channel 24 . First and second channels 20 , 24 define a fluid path through substrate 12 for fluid being pumped by the pump 16 . The cross-sectional area of the channels 20 , 24 can be the same or different from each other, but in either case are substantially less than the transverse cross-sectional area of pump 16 . Delivery system 10 can be used with multiple pumps. These additional pumps can be used to deliver different drugs (e.g., to allow the delivery of drug combinations or drug cocktails), or used in a cascaded or additive configuration (e.g., to increase the flow rate of the pumping mechanism with system 10 ). In another embodiment, one or more pumps are used to draw fluid out of a liquid reservoir to combine drugs or drug components. In another embodiment, delivery system 10 contains a mixer utilizing an unsteady output of a pump to combine drugs or drug components. Although the term “delivery system” is used, it should be noted that in all of the embodiments described herein, the pump can be used with the primary intent to deliver a foreign substance into the patient, or with the primary intent to extract a substance from the patient (such as blood for diagnostic purposes). In embodiments where a fluid circuit is used to both pass a substance into the patient and extract a substance from the patient, those of skill in the art will readily recognize that the pump accomplishes both a delivery and extraction function. In FIG. 1 , a single pump 16 accomplishes both functions, but system 10 can be configured with dedicated pumps where one or more pumps primarily (or exclusively) deliver a substance to the body and one or more different pumps primarily (or exclusively) extract a substance from the body. Drug perfusion tubing in the form of inlet and outlet tubes 22 , 26 can extend laterally from substrate 12 with terminal ends coupled in proximity to each other or coupled to an interface component 28 (e.g., a connector). For instance, the terminal ends of the tubes 22 , 26 on the patient-side can be configured or molded as a single dual lumen tube. Interface component 28 can be implanted into the inner ear (e.g., via a cochleostomy), allowing perilymph to circulate through tubes 22 and 26 , channels 20 and 24 , and pump 16 . Interface component 28 can also be secured to the scala tympani with an adhesive or a graft. While tubes 22 , 26 are described as “inlet” and “outlet” tubes in the example embodiment, those of skill in the art will understand that such terminology is for reference only, and that each tube can act as an inlet or an outlet depending on the direction of circulation of fluid through delivery system 10 . Tubes 22 , 26 can be manufactured from any desired metal, metallic alloy, or polymeric material (e.g., PEEK). One or more sheaths (not shown) can be used to cover each of tubes 22 , 26 , for example, to prevent kinking of tubes 22 , 26 or accommodate potential displacement of delivery system 10 within the mastoid bone. One sheath can cover both tubes 22 , 26 or separate sheaths can cover each tube 22 , 26 alone. A sensor (not shown) can also be included along inlet tube 22 or first channel 52 and used to analyze the fluid sampled by the system 10 . Alternatively (or additionally), the sensor (or the fluid being delivered by system 10 ). In an example embodiment, one or more reservoirs 30 are formed in substrate 12 for containing a substance, e.g., a medicament, a diagnostic agent, etc. Reservoir 30 can be in fluid communication with first channel 20 and/or second channel 24 such that the fluid circulating through delivery system 10 contacts the medicament contained in reservoir 30 . Reservoir 30 can be in fluid communication with first channel 20 and/or second channel 24 such that fluid does not circulate through delivery system 10 yet contacts the medicament contained in reservoir 30 . A plurality of reservoirs 30 can be in disposed in substrate 12 . In such embodiments, reservoirs 30 can be disposed in series or parallel along a channel. Examples of such arrangements are described in the incorporated U.S. Patent Application Publication 2011/0125136. FIG. 4A is a top down view of another example embodiment of delivery system 10 where multiple reservoirs 30 are present. FIG. 4B is a cross-sectional view taken along line 4 B- 4 B of FIG. 4A . Here, four reservoirs are present and immediately adjacent channel 24 . Medicament 40 in the form of a solid pill-like element is present within each reservoir 30 , where one type of medicament 40 - 1 is in two reservoirs and another type of medicament 40 - 2 is in the other two reservoirs. It should be noted that system 10 can be an integrated (or monolithic) device, or can be modular with, for instance, pump 16 in one module and reservoir 30 in a separate connectable module. Such a configuration would allow for easy replacement of the medicament. Reservoirs 30 can also be piggy-backed on each other, such that pumped fluid will contact a substance in a first reservoir, and that reservoir will empty (or the substance will be exhausted) before fluid contacts the same or a different substance in a second reservoir. In another embodiment, the terminal ends of the tubes 22 , 26 are coupled to two separate interface components, for example, to allow outlet tube 26 to be located in the tissue of interest and to allow inlet tube 22 to be coupled to a liquid reservoir containing, e.g., a liquid formulated drug or a carrier fluid for a drug in solid form located in reservoir 30 . The medicament contained in any reservoir 30 can be a solid formulation (e.g., a monolithic pill, particulates, etc.), a gel formulation (with or without a suspension), a liquid formulation, a slurry formulation, and the like. Example medicaments which can be included in the delivery system 10 are nomifensine and dexmethasone. However, those of skill in the art will understand that other medicaments can be utilized depending on the therapeutic purpose of the delivery system 10 . A more comprehensive (but non-exhaustive) list is provided in the “Substances and Applications” section. The medicament is preferably formulated to prevent portions of the medicament from breaking off and occluding any portion of system 10 , particularly channels 20 , 24 and/or tubes 22 , 26 . For example, the medicament can be disposed in a polymeric matrix which maintains structural integrity while in contact with the fluid circulating through delivery system 10 . A physical safeguard can also be used to prevent partial or complete occlusion. For instance, the medicament can be disposed in a semi-permeable membraneous coating, which can allow for diffusion of the fluid and the dissolved medicament, but prevent large particles of medicament from passing through. Alternatively (or additionally), a molecular sieve can be used as a filter that allows diffusion of the fluid and the dissolved medicament, but prevents large particles of medicament from passing through. The main body of system having substrate 12 is preferably small enough to be implanted without difficulty. In one example, which is provided for illustrative purposes only and is not intended to be limiting, the dimensions of the main body of system 10 (without the perfusion tubing) is 5 mm by 20 mm by 20 mm, although both smaller and larger sizes are possible. The perfusion tubes each preferably have a diameter of less than 1 mm, although larger sizes can be used. When used to treat diseases of the inner ear, e.g., tinnitus, the preferred depth of implantation into the scala tympani is less than 0.5 mm. FIGS. 2A-F depict an example embodiment of a manufacturing process for a delivery system 10 . This embodiment generally relates to a two layer system, although one of ordinary skill in the art will readily recognize that three or more layers can be used, depending on the complexity of the system, the number of pumps, reservoirs, sampling wells, channels, etc. In FIGS. 2A-B , a first layer 32 and a second layer 36 of substrate 12 are provided. Layers 32 and 36 can be formed or molded with the appropriate elements therein. This can be done by first creating a mold with the positive impressions of the elements thereon, such as through micromachining (e.g., soft lithography) or photolithography. Layers 32 and 34 will then be formed with negative impressions of those elements therein. For layer 32 , this includes a chamber for magnet 18 , reservoir 30 , and a vertical channel 34 , while for layer 36 , this includes the pump chamber 14 (present in this stage as an elongate recess), and first and second elongate channels 20 , 24 (not shown). The formation of layers 32 , 36 can also be done by micromachining or photolithography to etch or carve the elements directly into layers 32 , 36 . Magnet 18 is coupled to (or seated in) layer 32 after formation the magnet chamber. Afterwards, the magnet chamber can be filled with silicon. Beneath magnet 18 is a thin wall or membrane that can be displaced to generate the pumping forces. As shown in FIG. 2A , a vertical channel 34 is present to create a fluid path to/from reservoir 30 . FIG. 2C depicts a reservoir plug 38 . FIG. 2D depicts a medicament 40 disposed in reservoir 30 . In this example embodiment, medicament 40 is a solid pellet which sits in reservoir 30 and abuts an open end of vertical channel 34 . FIG. 2E shows reservoir plug 38 coupled to first layer 32 to seal medicament 40 in reservoir 30 . Plug 38 can be bonded to first layer 32 by plasma treatment, curing of first layer 32 , or through the use of an adhesive. In another example embodiment, plug 38 can be molded into first layer 32 . In yet another example embodiment, plug 38 can be a resealable septum which covers reservoir 30 but allows for re-filling, e.g., by a needle injecting a medicament into reservoir 30 . FIG. 2F shows first layer 32 coupled to the second layer 36 . First layer 32 forms a cover or roof to second layer 36 , enclosing the elongate recess to form pump chamber 14 with the thin pump chamber wall present in layer 32 . The elongate channels are also covered to fully enclose them (with the exception of the open ends through which fluid flows). In an example embodiment, layers 32 , 36 are bonded by O 2 plasma treatment and a subsequent bond curing period in an oven at 80° C. In another example embodiment, layers 32 , 36 can be bonded through thermal treatments at 80° C. by adjusting a ratio of a curing agent in a mixture used to fabricate layers 32 , 36 . In yet another example embodiment, layers 32 , 36 are sealed using UV ozone treatment or any other treatment which hydrophilizes the surface of silicone. In yet another example embodiment, layers 32 , 36 are bonded using an adhesive, e.g., uncured PDMS. In still another example embodiment, system 10 is hermetically sealed to prevent the intrusion of bodily fluids. An overmolding process is preferably used to secure the inlet and outlet tubes 22 , 26 with respect to channels 20 , 24 . FIGS. 2G-H depict an example method used in the securement of tubes 22 , 26 with respect to substrate 12 for a similar but alternate layout to system 10 . In this layout, reservoir 30 is located laterally offset from channel 24 and is coupled to channel 24 by way of two feeder channels 55 and 56 , each having a cross-sectional dimension less than channel 24 . This layout can allow for less concentrated doses. Preferably, after first layer 32 is coupled to second layer 36 , tubes 22 , 26 are press-fit into openings 60 , 61 for channels 20 , 24 , respectively. FIG. 2G shows the press-fitting insertion of tube 22 into opening 60 and along a length of channel 20 . An adhesive can be used to further secure the coupling of tubes 22 , 24 to substrate 12 after press-fitting. After both tubes are inserted, an overmolding process can then be used to encapsulate and fully secure tubes 22 , 26 to substrate 12 . Uncured silicone is poured into a mold holding tubes 22 , 26 in the substrate 12 and also holding layers 32 , 36 together. A priming solution can be used to increase bond strength between tubes 22 , 26 and substrate 12 . This assembly can then be baked in an oven (e.g., at 80° C.) and cured. The overmolding process adds an overmolded portion 58 to the length of substrate 12 and surrounds (or encapsulates) and stabilizes tubes 22 , 26 and layers 32 , 36 . The overmolding process can be followed by application of an adhesive to tubes 22 , 26 to further secure them to substrate 12 . In another example embodiment, tubes 22 , 26 are molded into first layer 32 or second layer 36 , or one tube is molded into first layer 32 and the other tube is molded into second layer 36 . FIGS. 3A-E show an example embodiment of medicament delivery by delivery system 10 . In FIG. 3A , fluid (e.g., perilymph) circulating through delivery system 10 contacts medicament 40 . For example, as the fluid enters delivery system 10 , the fluid can push up through vertical channel 34 and contact medicament 40 , which allows medicament 40 to dissolve or disperse into the fluid. As shown in FIG. 3B , prolonged contact between the fluid and medicament 40 , such as when pump 16 is inactive, can allow more of medicament 40 to dissolve into the fluid. Delivery system 10 can include valves to restrict flow during periods of pump inactivity. Multiple valves can be used. One or more valves can be placed before or after the pump along channel 20 and/or 24 . One or more valves can also be placed between reservoir 30 and channels 20 or 24 (e.g., valves in one or more of feeder channel 55 , feeder channel 56 , and vertical channel 34 ). The valves can be off-the-shelf or custom built. The valves can be micro-machined, or fabricated in MEMS, multi-leaflet (e.g., bi-leaflet), check, or pincher-type, to name a few. FIG. 3C shows a displacement of the dissolved medicament 40 when pump 16 is activated, e.g., by passing an external actuator (magnet) over magnet 18 . When this occurs, magnet 18 on pump 16 moves the wall on which it is mounted and compresses the pump chamber to push fluid through delivery system 10 . Vibrational waves travel along pump 16 and bounce off an interface between pump 16 and channels 20 , 24 , due to the rapid change in surface area between the cross-sectional area of pump chamber 14 and the cross-sectional area of channels 20 , 24 . Changing location of magnet 18 on axis L of pump 16 and/or changing the frequency of oscillations of pump 16 can increase/decrease, or even reverse direction of, fluid flow. FIG. 3D shows that while pump 16 is activated, the fluid can be pushed past vertical channel 34 and less fluid can contact medicament 40 . Thus, when pump 16 is inactive, a “dose” of medicament 40 can be allowed to dissolve into the fluid, as shown in FIG. 3E . In one example method of delivery, the fluid channels are allowed to fill with the drug and, while the pump remains inactive, the drug spreads diffusely as depicted in FIGS. 3A-B . This can be referred to as mode one. Once the effective dose has been reached, determined either by time or the presence of a sensor, pump 16 is activated and the drug is washed out with the fluid transitioning through the channels, as depicted in FIGS. 3C-D . This can be referred to as mode two. After this the pump is turned off again (or made inactive) as shown in FIG. 3E . The combination of modes one and two result in the delivery of the effective dose. Substances and Applications The substances that can be used with delivery system 10 , as well as the applications in which system 10 can be used, are very broad. As described in US Patent Application Publication 2009/0209945, there are numerous circumstances in which it can be desirable to deliver drugs or other agents in a tissue-specific manner, on an intermittent or continuous basis and using implantable drug delivery systems such as those described herein, to treat a particular condition. Disorders of the middle and inner ear can be treatable using the systems and methods described herein. Examples of middle and inner ear disorders include (but are not limited to) autoimmune inner ear disorder (AIED), Meniere's disease (idiopathic endolymphic hydrops), inner ear disorder associated with metabolic imbalances, inner ear disorder associated with infections, inner ear disorder associated with allergic or neurogenic factors, blast injury, noise-induced hearing loss, drug-induced hearing loss, tinnitus, presbycusis, barotrauma, otitis media (acute, chronic or serious), infectious mastoiditis, infectious myringitis, sensorineural hearing loss, conductive hearing loss, vestibular neuronitis, labyrinthitis, post-traumatic vertigo, perilymph fistula, cervical vertigo, ototoxicity, Mal de Debarquement Syndrome (MDDS), acoustic neuroma, migraine associated vertigo (MAV), benign paroxysmal positional vertigo (BPPV), eustachian tube dysfunction, cancers of the middle or inner ear, and infections (bacterial, viral or fungal) of the middle or inner ear. Degenerative ocular disorders can also be treatable using the systems and methods described herein. Examples of such degenerative ocular disorders include (but are not limited to) dry macular degeneration, glaucoma, macular edema secondary to vascular disorders, retinitis pigmentosa and wet macular degeneration. Similarly, inflammatory ocular diseases (including but not limited to birdshot retinopathy, diabetic retinopathy, Harada's and Vogt-Koyanagi-Harada syndrome, iritis, multifocal choroiditis and panuveitis, pars planitis, posterior scleritis, sarcoidosis, retinitis due to systemic lupus erythematosus, sympathetic ophthalmia, subretinal fibrosis, uveitis syndrome and white dot syndrome), ocular disorders associated with neovascularization (including but not limited to age-related macular degeneration, angioid streaks, choroiditis, diabetes-related iris neovascularization, diabetic retinopathy, idiopathic choroidal neovascularization, pathologic myopia, retinal detachment, retinal tumors, and sickle cell retinopathy), and ocular infections associated with the choroids, retina or cornea (including but not limited to cytomegalovirus retinitis, histoplasma retinochoroiditis, toxoplasma retinochoroiditis and tuberculous choroiditis) and ocular neoplastic diseases (including but not limited to abnormal tissue growth (in the retina, choroid, uvea, vitreous or cornea), choroidal melanoma, intraocular lymphoma (of the choroids, vitreous or retina), retinoblastoma, and vitreous seeding from retinoblastoma) can be treatable using the devices and methods described herein. Further examples of conditions that can be treatable using the devices and methods described herein include, but are not limited to, the following: ocular, inner ear or other neural trauma; disorders of the auditory cortex; disorders of the inferior colliculus (by surface treatment or injection); neurological disorders of the brain on top of or below the dura; chronic pain; hyperactivity of the nervous system; migraines; Parkinson's disease; Alzheimer's disease; seizures; hearing related disorders in addition to those specified elsewhere herein; nervous disorders in addition to those specified elsewhere herein; ophthalmic disorders in addition to those specified elsewhere herein; ear, eye, brain disorders in addition to those specified elsewhere herein; cancers in addition to those specified elsewhere herein; bacterial, viral or fungal infections in addition to those specified elsewhere herein; endocrine, metabolic, or immune disorders in addition to those specified elsewhere herein; degenerative or inflammatory diseases in addition to those specified elsewhere herein; neoplastic diseases in addition to those specified elsewhere herein; conditions of the auditory, optic, or other sensory nerves; sensory disorders in additions to those specified elsewhere herein; conditions treatable by delivery of drug to the vicinity of the pituitary, adrenal, thymus, ovary, testis, or other gland; conditions treatable by delivery of drug to the vicinity of the heart, pancreas, liver, spleen or other organs; and conditions treatable by delivery of drug to specific regions of the brain or spinal cord. The preceding identification of conditions is not intend to be exhaustive. Drug delivery systems and devices according to the embodiments described herein can be used to deliver one or more drugs to a particular target site so as to treat one or more of the conditions described above, as well as to treat other conditions. Drugs that can be delivered using the embodiments described herein include, but are not limited to, the following: antibiotics (including but are not limited to an aminoglycoside, an ansamycin, a carbacephem, a carbapenum, a cephalosporin, a macrolide, a monobactam, and a penicillin); anti-viral drugs (including but not limited to an antisense inhibitor, fomiversen, lamivudine, pleconaril, amantadine, and rimantadine); anti-inflammatory factors and agents (including but not limited to glucocorticoids, mineralocorticoids from adrenal cortical cells, dexamethasone, triamcinolone acetonide, hydrocortisone, sodium phosphate, methylprednisolone acetate, indomethacin, and naprosyn); neurologically active drugs (including but not limited to ketamine, caroverine, gacyclidine, memantine, lidocaine, traxoprodil, an NMDA receptor antagonist, a calcium channel blocker, a GABA A agonist, an α2δ agonist, a cholinergic, and an anticholinergic); anti-cancer drugs (including but not limited to abarelix, aldesleukin, alemtuzamab, alitretinoin, allopurinol, altretamine, amifostine, anastrolzole, anti-hormones such as Arimidex, azacitidine, bevacuzimab, bleomycin, bortezomib, busulfan, capecitabine, carboplatin, carmustine, chlorambucil, cisplatin, cyclophosphamide, cyclosporine, darbepoetin, daunorubicin, docetaxel, doxorubicine, epirubicin, epoetin, etoposide, fluorouracil, gemicitabine, hydroxyurea, idarubicin, imatinib, interferon, letrozole, methotrexate, mitomycin C, oxaliplatin, paclitaxel, tamoxifen, taxol and taxol analogs, topothecan, vinblastine and related analogs, vincristine, and zoledronate); fungicides (including but not limited to azaconazole, a benzimidazole, captafol, diclobutrazol, etaconazole, kasugamycin, and metiram); anti-migraine medication (including but not limited to IMITREX); autonomic drugs (including but not limited to adrenergic agents, adrenergic blocking agents, anticholinergic agents, and skeletal muscle relaxants); anti-secretory molecules (including but not limited to proton pump inhibitors (e.g., pantoprazole, lansoprazole and rabprazole) and muscarinic antagonists (e.g., atropine and scopalomine)); central nervous system agents (including but not limited to analgesics, anti-convulsants, and antipyretics); hormones and synthetic hormones in addition to those described elsewhere herein; immunomodulating agents (including but not limited to etanercept, cyclosporine, FK506 and other immunosuppressant); neurotrophic factors and agents (factors and agents retarding cell degeneration, promoting cell sparing, or promoting new cell growth); angiogenesis inhibitors and factors (including but not limited to COX-2 selective inhibitors (e.g., CELEBREX), fumagillin (including analogs such as AGM-1470), and small molecules anti-angiogenic agents (e.g., thalidomide)); neuroprotective agents (agents capable of retarding, reducing or minimizing the death of neuronal cells) (including but not limited to N-methyl-D-aspartate (NMDA) antagonists, gacyclidine (GK11), and D-JNK-kinase inhibitors); and carbonic anhydrase inhibitors (including but not limited to acetazolamide (e.g., DIAMOX), methazolamide (e.g., NEPTAZANE), dorzolamide (e.g., TRUSOPT), and brinzolamide (e.g., AZOPT)). In at least some embodiments, an implanted drug delivery system such as is described herein is used to deliver a drug (including but not limited to one or more of the drugs listed above) as a pure drug nanoparticle and/or microparticle suspension, as a suspension of nanoparticles and/or microparticles formed from drug formulated with binders and other ingredients to control release, or as some other type of nanoparticle- and/or microparticle-bound formulation. Nanoparticle- and/or microparticle-based delivery is advantageous in closed loop embodiments by allowing drug-containing particles to circulate within the closed loop as a solid suspended in the vehicle while delivering the desired therapeutic dose to the target tissue through the semi-permeable membrane or hollow fiber. Nanoparticle- and/or microparticle-bound delivery also offers the advantage of maintaining drug stability and avoiding loss of drug to polymeric components that can be encountered in a fluid pathway. Many diseases and disorders are associated with one or more of angiogenesis, inflammation and degeneration. To treat these and other disorders, the embodiments disclosed herein can permit delivery of anti-angiogenic factors; anti-inflammatory factors; factors that retard cell degeneration, promote cell sparing, or promote cell growth; and combinations of the foregoing. Diabetic retinopathy is characterized by angiogenesis. At least some embodiments contemplate treating diabetic retinopathy by implanting devices delivering one or more anti-angiogenic factors either intraocularly, preferably in the vitreous, or periocularly, preferably in the sub-Tenon's region. It can also be desirable to co-deliver one or more neurotrophic factors either intraocularly, periocularly, and/or intravitreally. Uveitis involves inflammation. At least some embodiments contemplate treating uveitis by intraocular, vitreal or anterior chamber implantation of devices releasing one or more anti-inflammatory factors. Anti-inflammatory factors contemplated for use in at least some embodiments include, but are not limited to, glucocorticoids and mineralocorticoids (from adrenal cortical cells). Retinitis pigmentosa is characterized by retinal degeneration. At least some embodiments contemplate treating retinitis pigmentosa by intraocular or vitreal placement of devices secreting one or more neurotrophic factors. Age-related macular degeneration (wet and dry) involves both angiogenesis and retinal degeneration. Embodiments described herein can be used to deliver one or more neurotrophic factors intraocularly, preferably to the vitreous, and/or one or more anti-angiogenic factors intraocularly or periocularly, preferably periocularly, most preferably to the sub-Tenon's region. Glaucoma is characterized by increased ocular pressure and loss of retinal ganglion cells. Treatments for glaucoma contemplated in at least some embodiments include delivery of one or more neuroprotective agents that protect cells from excitotoxic damage. Such agents include, but are not limited to, N-methyl-D-aspartate (NMDA) antagonists and neurotrophic factors. These agents can be delivered intraocularly, preferably intravitreally. Gacyclidine (GK11) is an NMDA antagonist and is believed to be useful in treating glaucoma and other diseases where neuroprotection would be helpful or where there are hyperactive neurons. Additional compounds with useful activity are D-JNK-kinase inhibitors. Neuroprotective agents can be useful in the treatment of various disorders associated with neuronal cell death (e.g., following sound trauma, cochlear implant surgery, diabetic retinopathy, glaucoma, etc.). Examples of neuroprotective agents that can be used in at least some embodiments include, but are not limited to, apoptosis inhibitors, caspase inhibitors, neurotrophic factors and NMDA antagonists (such as gacyclidine and related analogs). At least some embodiments can be useful for the treatment of ocular neovascularization, a condition associated with many ocular diseases and disorders and accounting for a majority of severe visual loss. For example, contemplated is treatment of retinal ischemia-associated ocular neovascularization, a major cause of blindness in diabetes and many other diseases; corneal neovascularization; and neovascularization associated with diabetic retinopathy, and possibly age-related macular degeneration. One or more of the embodiments described herein can be used to deliver an anti-infective agent, such as an antibiotic, anti-viral agent or anti-fungal agent, for the treatment of an ocular infection. They can also be used to deliver a steroid, for example, hydrocortisone, dexamethasone sodium phosphate or methylprednisolone acetate, for the treatment of an inflammatory disease of the eye. One or more of the embodiments described herein can be used to deliver a chemotherapeutic or cytotoxic agent, for example, methotrexate, chlorambucil, or cyclosporine, for the treatment of a neoplasm. They can also be used to deliver an anti-inflammatory drug and/or a carbonic anhydrase inhibitor for the treatment of certain degenerative ocular disorders. Chronic infections located in a specific tissue and suppressible by long-term local treatment without developing resistance (e.g., viral infections) can be treated using one or more of the embodiments described herein. The above list of treating drug and treated condition examples are merely illustrative and do not exclude uses of one or more other drugs in the previous list of example drugs to treat a condition in the previous list of example conditions. The devices and systems described herein can be configured for use in veterinary, diagnostic, laboratory, clinical research and development (“clinical R&D”) or other types of environments, as well as use of such devices and/or systems in such environments. While the specification describes particular embodiments of the systems, devices, and methods described herein, those of ordinary skill can devise variations to this subject matter without departing from the spirit and scope of the present disclosure. Thus, the claims are not intended to be limited to the embodiments shown, but are to be accorded the full scope consistent with the language of the claims, where reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later come to be known to those or ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedication to the public regardless of whether such disclosure is explicitly recited in the claims. No claim elements are to be construed under the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.”

1a

BACKGROUND OF THE INVENTION [0001] The current invention generally relates to an apparatus for detecting force or pressure applied to the bottom of a foot and lower extremity, and more particularly, to an apparatus for detecting the application of a predetermined threshold amount of force or pressure applied to a cast, boot, shoe, mat, insole, sock, or other lower extremity immobilization or protective device, where the predetermined threshold relates to a pressure threshold that could be deleterious or harmful if exceeded (including situations where patients are recovering from a bony fracture, tendon injury, and recent lower extremity surgery). [0002] A recurring problem with recovery from an injury in a lower extremity, such as a leg or foot, is the risk of secondary injuries or trauma. As patients begin recovering, they naturally want to resume their typical routine, and in many cases the increased activity is part of their rehabilitation regime. However, even if a patient is generally aware and exercising care not to place undue pressure on a recovering extremity, it is difficult for most people to remember how much a given threshold weight feels like when using their legs, and even the best of patients find it difficult to remain conscious of the need to avoid more than that threshold, avoid missteps or loss of balance, or the like, all events which could lead to too much pressure being exerted. [0003] To minimize the risk of new injury or trauma, a variety of alert devices have been developed to assist in warning patients as too much weight is being exerted. Despite the extensive development of such devices, they continue to exhibit certain disadvantages. For example, their designs are: (1) too complex, (2) too costly, (3) and fail to fully record and document all incidents in which too much pressure has been exerted. Thus, there exists a continuing need for the development of new and improved, easier to use and inexpensive devices for the detection of force or pressure applied to a cast, boot, shoe, mat, sock, insole, or other lower extremity immobilization or protective device. SUMMARY OF THE INVENTION [0004] Recognizing the need for the development of improved pressure monitoring under or within, for example, a cast, boot, shoe, mat, sock, insole or other lower extremity immobilization or protective device, the present invention is generally directed to satisfying the needs set forth above and overcoming these and other disadvantages with prior art devices and to providing a device that is comfortable or at least not uncomfortable when used. [0005] An illustrative, but not inclusive, listing of advantages that may now be realized in various exemplary embodiments of the present invention include: providing a pressure detection device that is simple to construct and use and whose manufacturing costs my be kept to a minimum; providing a pressure detection device that will detect that a threshold of pressure has been applied to the bottom of a cast, boot, shoe, or other lower extremity immobilization or protective device; and providing a pressure detection device that will alert both the patient and health care provider detect that pressure has been applied to the bottom of a cast, boot, shoe, or other lower extremity immobilization or protective device, such that, for instance: (1) appropriate counseling may be undertaken, (2) further instruction or physical therapy can be provided to the patient, or (3) the protective device may be appropriately augmented. BRIEF DESCRIPTION OF THE DRAWINGS [0006] FIG. 1A diagrammatically illustrates a bottom and side view of a first exemplary embodiment of the present invention. [0007] FIG. 1B diagrammatically illustrates a bottom and side view of a second exemplary embodiment of the present invention. [0008] FIG. 1C diagrammatically illustrates a bottom and side view of a third exemplary embodiment of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0009] In the following, FIGS. 1A-1C diagrammatically illustrate various embodiments of the present invention. These figures respectively depict illustrative bottom and right side cross-sectional views each of different passive foot pressure detection devices in accordance with embodiments of the present invention. In this and the other figures, the symbol “•” is used to schematically represent pressure sensitive chambers. [0010] In accordance with embodiments of the present invention, the pressure sensitive chambers are preferably designed to burst or otherwise release their contents at a known, e.g., pre-determined force or weight. As will be recognized by those skilled in the art, the pressure that the chambers burst depends upon the material of chambers and, for example, the thickness of the chamber walls. These parameters are well known to those skilled in the art, and are therefore not discussed herein. [0011] The pressure sensitive chambers may be filled with air or other gases, a suitable liquid, or semi-liquid or releasable solids (e.g., a fine granular solid) material; either dyed or undyed. They can be filled with miniature or sub microscopic particulate transmitters that permit continuous or immediate identification of their location in space. [0012] The pressure sensitive chambers themselves may be made from any appropriate material, such as plastics, and will typically be the same as the material of the base. The base material may be of any desired shape and thickness, e.g., up to several mm if serving as an insert. Or, for example, the base material need be no thicker than needed to serve as an adhesive tape. In the adhesive example, the adhesive can be on one side and the pressure sensitive chambers (e.g., micro-bubbles) formed onto the opposite side. The adhesive or attaching materials, when used, could be any suitable adhesive for attachment to a lower extremity device, such as a cast, a boot, a shoe, or other lower extremity immobilization or protective device (“LED”). The pressure sensitive device can be fabricated of any suitable material, such as, for example, plastic, polymer, cloth, foam, cork, rubber, natural or synthetic material, or some combination thereof of these materials. In some embodiment it may be desirable to select a material for the pressure sensitive chambers that is temperature and/or moisture resistant so that the pressure sensitive chambers do not spontaneous rupture prior to application of the predetermined force or pressure and so that the mechanical properties of the device are not altered upon exposure to the environment. The base can be constructed of the same material if desired. [0013] While the present embodiments are preferably formed for lower extremity devices, the present invention is not limited to such use, and can be utilized in any manner where excessive force is desired to be monitored in connection with any limb, appendage or body part that when in contact with the environment creates a mechanical pressure. [0014] In the exemplary embodiments, the device is preferably flat and may or may not have adhesive or some other method for securing the device such as, but not limited too, clasps, Velcro, etc, on the side opposite of the pressure sensitive chambers. Other ways of attaching the device may be used, such as adhesive tabs. Or course, in some situations, it is not necessary to secure the device. [0015] In the exemplary embodiments, the shape of the device approximates the shape of the human foot in the transverse plane. However, the device may also be made in other shapes, including, but not limited to, oval, rectangular, circular, square, and eccentric shapes, or any limb, appendage or body part that when in contact with the environment creates a mechanical pressure desired to be monitored. [0016] Referring to FIG. 1A , this figure diagrammatically illustrates a bottom and side view of a first exemplary embodiment of the present invention. In FIG. 1 , there are two regions/clusters of pressure sensitive chambers (a); one located in the heel region of the base (b) and the other in the forefoot region of the base (b). In this case, a single pressure detection device (“PDD”) can serve as an insert, e.g., formed to fit in shoes or other LED's without sliding, or as an externally attachable unit. [0017] FIG. 1B diagrammatically illustrates a bottom and side view of a second exemplary embodiment of the present invention. In FIG. 1B , there are several regions/clusters of pressure sensitive chambers (a) distributed over the base (b) of the pressure detection device. The distribution of the pressure sensitive chambers (a) need not be uniform as shown in the example of FIG. 1B . [0018] FIG. 1C diagrammatically illustrates a bottom and side view of a third exemplary embodiment of the present invention. In FIG. 1C , the pressure sensitive chambers (a) are distributed in a non-clustered fashion over the entire base (b) of the pressure sensitive device. Again, as in the exemplary embodiment of FIG. 1B , the distribution of the pressure sensitive chambers need not be uniform as shown in FIG. 1C . [0019] In accordance with embodiments of the present invention, the pressure sensitive chambers can be arranged in rows and/or columns such that a set amount of force or pressure will burst substantially all the pressure sensitive chambers of one row, column, or cluster. [0020] In accordance with one preferred embodiment of the present invention, a pressure detection device can be applied to the bottom of a cast, boot, shoe, or other lower extremity immobilization or protective device by, for example, an adhesive applied to the superior aspect of the PDD. The PDD comprises a single pressure sensitive chamber or set of pressure sensitive chambers, fixedly attached to a backing material or base, and with the adhesive on a first side of the material. When the adhesive is exposed or activated, a user (e.g., a medical doctor) applies the PDD to a desired region of the LED for monitoring pressure in that region. Multiple PDDs can be applied to different regions of the LED, allowing detection of excess pressure at each of the regions. [0021] Further, the cell(s) of each PDD have a predetermined pressure threshold, which if exceeded leads to a destructive (e.g., bursting) or non-destructive (e.g., release via a valve, that can be refilled) change in the cell(s), which readily indicates that the threshold pressure was exceeded. A destructive release is preferred, as being the easiest and most economical form of PDD to make and maintain. If the PDDs are formed in the shape of strips (e.g., FIG. 2 ), all pressure sensitive chambers in a given strip can be conveniently designed to burst at the same pressure threshold, and different strips having different pressure thresholds can be designated by any convenient manner (e.g., color or alphanumeric coding on the strip). Alternatively, a given strip can be utilized that has pressure sensitive chambers with multiple thresholds. For example, a first threshold can be used to warn the patient visibly or by giving a popping noise, that he/she is using pressure close to an unsafe threshold, and pressure sensitive chambers with a second threshold can be used that burst when an unsafe threshold is exceeded. As will be recognized by those skilled in the art, the present invention contemplates that the pressure sensitive chambers be in the base, such as with material that has the chambers formed in the base such as, for example a suitably strengthened form of bubble wrap, to provide the popping, or on the base such as shown in the figures. The present invention is not limited to any particular structure or arrangement of the pressure sensitive chambers. [0022] In another embodiment of the present invention, the pressure detection device may be inserted within some portion a cast, boot, shoe, mat, sock, insole, or other lower extremity immobilization or protective device. [0023] In another embodiment of the present invention, the pressure detection device may be encased in a protective envelope consisting of a material that will protect the individual chambers from abrasive wear. [0024] Alternatively, in another embodiment of the present invention, the pressure detection device may be covered with or positioned adjacent to an absorbent material or adsorbent material. Such materials can be selected, as known to those skilled in the art, to exhibit the efflux of the contents of the burst pressure sensitive chamber or chambers. [0025] Of course, one skilled in the art will appreciate how a variety of alternatives are possible for the individual elements, and their arrangement, described above, while still falling within the spirit of the invention. Thus, for example, the pressure sensitive chambers may be any commercially available bursting cell. Examples of suitable base materials have been given above, and one skilled in the art will appreciate that a variety of different PDD(s) may be used with different LEDs, the particular selection being a matter of design choice. Any convenient material (adhesives, tapes, velcro patches, heat sealing, etc.) or process may be used to help fix the position of the pressure sensitive chambers of the PDD so they are maintained proximate the desired region of the LED/foot when worn. Alternatively, part of the attachment mechanism for the PDD/pressure sensitive chambers (e.g., the base of a 2-part velcro-style patch) can be formed as an part of a regular or specialized LED or LED insert if desired, already appropriately positioned when forming the LED. [0026] While the above describes several embodiments of the invention used primarily in connection with an adjustable cell system in treating positional hindfoot disorder, those skilled in the art will appreciate that there are a number of alternatives, based on system design choices and choice of protocol options, and extensions that still fall within the spirit of my invention. Thus, it is to be understood that the invention is not limited to the embodiments described above, and that in light of the present disclosure, various other embodiments and applications should be apparent to persons skilled in the art. Accordingly, it is intended that the invention not be limited to the specific illustrative embodiments.

1a

BACKGROUND [0001] Many homes utilize cabinets as a means of storage. Cabinets allow people to store items on shelves with opening and closing doors. Cabinets are often placed high along walls and may have deep storage areas. These high locations and deep storage areas often present difficulties for shorter people, such as children, who require assistance to reach items in hard-to-reach areas of the cabinets. It would be useful to have new and innovative way to reach items that may be on high cabinet shelves or deep within cabinet storage systems. SUMMARY [0002] This invention relates to a device for making cabinet storage easier to access. The device is composed of a base, slideable parts, gyrate brackets, and shelf frames. This device allows shorter people to access cabinet storage that would otherwise be out of reach. [0003] These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0004] FIG. 1 is a 3-dimensional view of an embodiment of the device in the folded state. [0005] FIG. 2 is a 3-dimensional view of an embodiment of the device in the opened state. [0006] FIG. 3 is a side view of an embodiment of the device in the opened state. [0007] FIG. 4 is a side view of a base component of an embodiment of the device. [0008] FIG. 5 is an isometric view of a base component of an embodiment of the device. [0009] FIG. 6 is a side view of a slideable part component of an embodiment of the device. [0010] FIG. 7 is an isometric view of a slideable part component of an embodiment of the device. [0011] FIG. 8 is a side view of gyrate bracket components of an embodiment of the device. [0012] FIG. 9 is a side view of a shelf frame component of an embodiment of the device. [0013] FIG. 10 is an isometric view of a shelf component of an embodiment of the device. [0014] FIG. 11 is a front view of a shelf frame with shelves of an embodiment of the device. DETAILED DESCRIPTION [0015] In the particular embodiment illustrated in FIG. 2 , the device 100 is composed of two bases 110 , two slideable parts 120 , six gyrate brackets 130 , two shelf frames 140 , and three shelves 150 . [0016] Each base 110 is composed of metal, wood, or another strong material, depending on weight, strength, and cost considerations. Each base 110 is mounted on one side of a cabinet compartment where the device will be installed. The bases 110 are mounted on the cabinet compartment using traditional means, such as mounting brackets, bolts, screws, nails, or other appropriate means. The pair of bases 110 is intended to act as the main support for the device. [0017] As illustrated in FIG. 4 , each base 110 has two sets of rails 112 , one near the top and one near the bottom. Rails 112 connect slideable parts 120 . Rails 112 allow slideable parts 120 to slide in and out of the cabinet space via wheels, ball bearings, or other appropriate means. [0018] Each base 110 has a slot 116 located below top rail 112 . Slot 116 is a shallow, horizontal groove that provides a guide for the sliding action of slideable part 120 . Slot 116 prevents slideable part 120 from sliding all the way out of the cabinet. [0019] Bases 110 may optionally have grooves 118 . Grooves 118 are areas of thinner material or no material at all that reduce the weight of bases 110 . Grooves 118 may be necessary depending on the material that bases 110 are constructed from, in order to provide sufficient strength without being too heavy. [0020] Between the bottom of the cabinet and each base 110 are wedges 114 . Wedges 114 are composed of plastic or other lightweight, strong material. Wedges 114 are square shaped, or can be another shape if the space requires it. Wedges 114 lift bases 110 off the bottom of the cabinet so that slideable parts 120 will clear any lip on the bottom of the cabinet. Wedges 114 are sized appropriately to provide enough space as is needed. Wedges 114 may optionally be placed between the sides of bases 110 and the cabinet walls in order to provide enough space for slideable parts 120 to clear any lip on the sides of the cabinet. [0021] Slideable parts 120 are composed of similar material to the rest of the device, such as wood or metal, depending on strength, weight, and cost considerations. As illustrated in FIG. 7 , each slideable part 120 has rails 122 . Rails 122 are sized to fit inside of rails 112 . Rails 122 allow slideable part 120 to slide partially out of the cabinet space. Guide 124 is a short protrusion intended to fit in slot 116 . Guide 124 prevents slideable part 120 from sliding all the way out of the cabinet space. [0022] Each slideable part 120 has at least 3 pins 126 . Pins 126 are short, cylindrical protrusions intended to attach gyrate brackets 130 . Pins 126 are located near the bottom of slideable part 120 , nearly evenly distributed horizontally. One of the pins 126 , typically the pin closest to the rear wall of the cabinet, is located higher than the others. [0023] Each slideable part 120 has a groove 128 . Groove 128 is a shallow curved groove intended to provide stability to the operation of gyrate brackets 130 . Groove 128 is located and shaped such that it forms an arc with center pin 126 as the anchor. [0024] Each slideable part has a spring hole 127 . Spring hole 127 is a small hole which allows a spring to be mounted. [0025] Slideable parts 120 may optionally have grooves 129 . Grooves 129 are areas of thinner material or no material at all that reduce the weight of slideable parts 120 . Grooves 129 may be necessary depending on the material that slideable parts 120 are constructed from, in order to provide sufficient strength without being too heavy. [0026] The particular embodiment described uses three gyrate brackets 130 for each side, as shown in FIG. 8 . Each gyrate bracket 130 is composed of a strong material such as metal. Each gyrate bracket 130 is shaped as a long, thin rectangle with rounded corners. Each gyrate bracket 130 has two pinholes 138 , located near either end of gyrate bracket 130 . Pinholes 138 are sized and shaped such that pins 126 will fit inside. Center gyrate bracket 134 has an additional protrusion which contains spring hole 137 . Center gyrate bracket 134 also has pin 139 . Pin 139 is a protruding pin sized to fit in groove 128 . Center gyrate bracket 134 has a thinner top section with less material, which corresponds to a similar bottom section of bottom gyrate bracket 136 . [0027] When assembled, top gyrate bracket 132 connects to slideable part 120 via rear pin 126 , as shown in FIG. 3 . Top gyrate bracket 132 also connects to shelf frame 140 via pin 142 . Center gyrate bracket 134 connects to slideable part 120 via center pin 126 , while pin 139 fits into groove 128 to provide additional stability when opening and closing the device. Center gyrate bracket 134 connects to spring 135 via spring hole 137 . The other end of spring 135 connects to slideable part 120 via spring hole 127 . Spring 135 assists in closing operations by providing additional force from the tension in the spring 135 . Center gyrate bracket 134 also connects to shelf frame 140 via pin 142 . Bottom gyrate bracket 136 connects to slideable part 120 via bottom pin 126 . Bottom gyrate bracket 136 also connects to shelf frame 140 via pin 142 . Though not pictured, a washer is typically placed between gyrate brackets 132 , 134 , and 136 , and slideable part 120 to prevent friction damage. [0028] Shelf frames 140 are composed of similar material to the rest of the device, such as wood or metal, depending on strength, weight, and cost considerations. As shown in FIG. 9 , each shelf frame 140 has pins 142 , grooves 144 , and slideable wedges 148 . Pins 142 are sized to fit gyrate brackets 130 . Pins 142 are positioned such that when gyrate brackets 130 are connected, each shelf frame 140 is in a level position. Slideable wedges 148 are composed of plastic or similar material that allow sliding with little friction. Slideable wedges 148 are attached to each shelf frame 140 by glue or other appropriate means. Slideable wedges 148 allow for easier opening and closing and prevent the shelf frames 140 from contacting the surface of bases 110 . [0029] Shelf frames 140 may optionally have grooves 146 . Grooves 146 are areas of thinner material or no material at all that reduce the weight of shelf frames 140 . Grooves 146 may be necessary depending on the material that shelf frames 140 are constructed from, in order to provide sufficient strength without being too heavy. [0030] Shelves 150 are composed of wood, plastic, metal, or other material appropriate for shelves. As shown in FIG. 10 , each shelf 150 has a basic shelf 152 , and optionally side holders 156 , and optionally mounting brackets 154 . Basic shelf 152 is a rectangular piece of material that functions as a typical shelf. Optional side holders 156 are lips placed at the front and back of shelves 150 in order to prevent items from falling off during opening and closing operations. Optional side holders 156 are attached to each basic shelf 152 by appropriate means such as brackets, bolts, screws, nails, pins, or glue. Optional mounting brackets 154 are attached to each basic shelf 152 using bolts, screws, or other typical means. Optional mounting brackets 154 are then placed into grooves 144 at whatever location is appropriate to achieve the desired shelf height. Other means of mounting the shelves 150 to the shelf frames 140 may also be used, such as bolts, screws, nails, pins, or glue. [0031] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are contemplated herein.

1a

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] Not Applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] Not Applicable. BACKGROUND OF THE INVENTION [0003] The present invention relates to wearable devices that dispense chemicals such as insect repellents and/or fragrances. [0004] Various techniques have been developed to provide humans with protection from insect bites. For insect control inside buildings a primary emphasis is placed on trying to keep insects from entering the building at all (e.g. placing screens over windows). This sometimes is supplemented with chemical treatment of room air and/or the use of traps. See e.g. U.S. Pat. Nos. 6,582,714 and 7,175,815, and also U.S. Patent Application Publication Nos. 2005/0079113, 2006/0039835, 2006/0137241 and 2007/0036688. [0005] When the individual is outdoors where the area cannot be effectively screened, and the individual is mostly staying in a particular area (e.g. at a picnic, or on a patio near a building), traps and area-repellents are the primary focus. [0006] Alternatively, when the individual is moving away from a single area that they control, individuals often apply a personal insect repellent to clothing or directly to their skin. However, some consumers have expressed a reluctance to apply insect repellents directly to their skin or to delicate clothing. [0007] As a result, portable electrical devices having a fan and an insecticide source have been developed. These devices may have a clip so that they can easily be mounted on a belt, a purse, or even a pocket, and thus be “worn” by the consumer as they move outside. The device may draw air through, or blow air past, a substrate impregnated with an insect repellent or other air treatment chemical, thereby dispensing the active into the air, preferably (in the case of a repellent) downward along the outside of a human's clothing. See, for example, U.S. Pat. Nos. 6,926,902, 7,007,861, 7,152,809, and 7,168,630, and U.S. Patent Application Publication Nos. 2003/0044326, 2003/0175171, 2007/0183940, and 2009/0060799 (also ES 1063655). [0008] However, some such devices may blow the active too far out away from the human body, causing too little of the active to reach locations of primary concern (e.g. near ankles). Other such devices do not provide a way of minimizing waste of the active, such as while blower operation is suspended between uses. Still other such devices are unduly costly, are too heavy, or have other deficiencies. [0009] The deficiencies in the above noted devices have been addressed by the wearable chemical dispensers described in U.S. Patent Application Publication Nos. 2008/0141928 and 2009/0008411. However, it is still desirable to improve this type of product further, particularly with respect to making the device even more compact and lightweight, making the device easier to use when the consumer is seated, and making the refill unit for the air treatment chemical easier to replace when used up. [0010] Hence, a need still exists to improve devices of this type in these areas. SUMMARY OF THE INVENTION [0011] In one aspect the invention provides a wearable device for dispensing an air treatment chemical, where the device has: [0012] (a) a housing including an inlet for permitting air to enter into an interior space of the housing and including an outlet for permitting air mixed with air treatment chemical to exit the interior space; [0013] (b) a substrate positioned in the housing, the substrate bearing an air treatment chemical; [0014] (c) a power supply mounted to the housing; [0015] (d) a motor mounted in the housing, the motor being powered by the power supply; and [0016] (e) a fan mounted in the housing, the fan being capable of moving air from the inlet adjacent the substrate so as to mix air treatment chemical into the moving air, and then deliver a mixture of air and air treatment chemical through the outlet to outside of the housing, the fan including a rotor connected to the motor and a plurality of spaced apart blades connected to and extending away from the rotor. [0017] In one form, the device can maintain an average volumetric flow rate of air of at least 1.5 cubic feet per minute (cfm) (0.042 m 3 /min.) over a twelve hour period with the device consuming from the power supply 0.35 watts or less of power for the twelve hour period. [0018] In particularly preferred forms of this aspect of the invention the fan includes 12 to 18 blades (e.g. 13 to 15 blades, e.g. 14 blades), and each blade has a body extending from an inner edge to an outer edge, the inner edge of each blade being spaced a distance from a centerpoint of the rotor along a radial line from the centerpoint of the rotor, the body of a plurality of such blades: [0019] (a) forming an included angle with its associated radial line in the range of 100 to 150 degrees; and/or [0020] (b) having a length measuring 80% to 130% of a distance from a centerpoint of the rotor to the inner edge of the blade; and/or [0021] (c) having a length measuring 45% to 75% of a distance from a centerpoint of the rotor to the outer edge of the blade; and/or [0022] (d) having a length from a centerpoint of the rotor to an outer edge of the rotor of 10 to 50 millimeters. [0023] The rotor can include a central wall spaced inward from a perimeter of the rotor and the wall defines a recess in the rotor. At least a portion of the motor is positioned in the recess, and the blades extend from the wall radially outward toward the perimeter of the rotor. [0024] In other preferred forms the housing has a plurality of spaced apart openings, the openings being spaced around at least 180 degrees (more preferably at least 235 degrees) of a side structure of the housing, and a plurality of the blades are substantially perpendicular to a front wall of the housing, the front wall of the housing having an array of inlet apertures. The device can produce an average volumetric flow rate of air of at least 1.5 cubic feet per minute over a twelve hour period (preferably for an even longer period), yet is so efficient in energy use and power requirements more compact batteries (e.g. AAA rather than AA) can be used to power the device. This not only makes the device more compact from that factor, this permits the batteries to be positioned in an otherwise unavailable location, thereby further reducing the size and weight of the device. [0025] In another aspect the invention provides a wearable device for dispensing an air treatment chemical, where the device has: [0026] (a) a housing including an inlet for permitting air to enter into an interior space of the housing and including an outlet for permitting air mixed with air treatment chemical to exit the interior space; [0027] (b) a substrate positioned in the housing, the substrate bearing an air treatment chemical; [0028] (c) a power supply mounted to the housing; [0029] (d) a motor mounted in the housing, the motor being powered by the power supply; [0030] (e) a fan connected to the motor, the fan being capable of moving air from the inlet adjacent the substrate so as to mix air treatment chemical into the moving air, and then deliver a mixture of air and air treatment chemical through the outlet to outside of the housing; and [0031] (f) a clip rotatably connected to an outer wall of the housing. [0032] Preferred forms of this device are where one of the clip and the outer wall of the housing includes a projection, the other of the clip and the outer wall of the housing includes an arcuate well, and the projection moves in the well when rotating the clip. For example, the well can be dimensioned such that the clip can rotate at least 90 degrees, and there can be a means for indexed rotational positioning of the housing and the clip relative to each other. This latter feature can be a detent system where there is a flexible tab on one of the clip and housing, and a series of distinct rest positions for the tab on another of the clip and housing. For example, each such rest position can be in the form of a depression, and the tab can have a projection thereon. [0033] In yet another aspect of the invention there is provided a wearable device for dispensing an air treatment chemical, the device having: [0034] (a) a housing including a first main housing section and a second lid housing section, the first main housing section and the second lid housing section defining an interior space of the housing when the first main housing section and the second lid housing section are in a closed position, the housing having an inlet for permitting air to enter into an interior space of the housing, and an outlet for permitting air mixed with air treatment chemical to exit the interior space; [0035] (b) a substrate positioned in the interior space of the housing, the substrate bearing an air treatment chemical; [0036] (c) a power supply mounted to the housing; [0037] (d) a motor mounted in the interior space of the housing, the motor being powered by the power supply; [0038] (e) a fan connected to the motor, the fan being capable of moving air from the inlet adjacent the substrate so as to mix air treatment chemical into the moving air, and then deliver a mixture of air and air treatment chemical through the outlet to outside of the housing; and [0039] (f) a hinge mechanism connecting the first main housing section and the second lid housing section for governing pivotal movement between a closed position and an open position of the second lid housing section relative to the first main housing section, the hinge mechanism comprising a pair of spaced apart hinge arms mounted on the second lid housing section, and a pair of spaced apart notches positioned on the first main housing section, each hinge arm including a pivot pin, each pivot pin capable of rotating within an associated one of the notches. [0040] In preferred forms of this aspect of the invention the pivot pin of each hinge arm extends laterally adjacent an end of the hinge arm, each such pivot pin having an outer wall having a flat section, and the flat section of each such pivot pin is mounted in a notch to contact a flat surface of its associated notch when the second lid housing section is in the fully open position. [0041] Each such pivot pin may also have on an outer wall a second flat section, and the second flat section of each pivot pin contacts a flat surface of its associated notch when the second lid housing section is in the fully open position. For example, the notches can be generally rectangular. These structures are most useful when their is a frame in the housing for supporting the substrate, the frame including a pair of slots, and each of the hinge arms moves within one of the slots during pivotal movement between the closed position and the fully open position of the second lid housing section. [0042] Hence, it should be appreciated that the devices of the present invention have more efficient power usage, thereby permitting smaller power supplies and in any event a more compact and more lightweight assembly. Further, these devices make it more comfortable for the device to be operated even when the consumer is sitting and also provide greater control of the dispensing direction. Also, the special hinging and notch arrangement holds the lid open during replacement of the refill of active, but will cause the lid to snap to the closed once the lid is moved to a defined midpoint. This facilitates refill replacement. [0043] These improvements lower the cost of production, permit the device to be operated at lower cost, and meets consumer preferences to minimize the weight of the device if a device like this is to be used. [0044] These and other advantages of the present invention will become better understood upon consideration of the following detailed description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0045] FIG. 1 is a left, top, frontal perspective view of a wearable chemical dispenser according to the invention; [0046] FIG. 2 is a left side elevational view of the dispenser of FIG. 1 ; [0047] FIG. 3 is a right side elevational view of the dispenser of FIG. 1 ; [0048] FIG. 4 is a rear elevational view of the dispenser of FIG. 1 ; [0049] FIG. 5 is a right, bottom perspective view of the dispenser of FIG. 1 , albeit with the lid in an open position; [0050] FIG. 6 is an exploded perspective view of the dispenser of FIG. 1 ; [0051] FIG. 7 is a cross-sectional view taken along line 7 - 7 of FIG. 5 ; [0052] FIG. 8 is an enlarged detailed perspective view focusing on the hinge supports of the dispenser of FIG. 1 ; [0053] FIG. 8A is an enlarged detailed cross-sectional view of one arm of the hinge in one hinge support, with the lid in a fully open position; [0054] FIG. 8B is a view similar to FIG. 8A , but with the lid instead in only a partially open position; [0055] FIG. 8C is a view similar to FIG. 8A , but with the lid instead in the closed position; [0056] FIG. 9 is a view taken along line 9 - 9 of FIG. 7 , albeit with the clip added in phantom to show where its relative position would be if viewable in rear view; [0057] FIG. 10 is an enlarged frontal view of the rotating clip of the dispenser of FIG. 1 by itself; and [0058] FIG. 11 is a top view of the rotor fan of the dispenser of FIG. 1 . DETAILED DESCRIPTION OF THE INVENTION [0059] A preferred example wearable chemical dispenser 18 is shown in FIGS. 1-11 . The wearable chemical dispenser 18 includes a top housing section 20 having a generally oblong side wall 22 that extends from a top wall 23 . In use, the wall 23 is typically frontally disposed and acts as a lid. A plurality of spaced apart apertures 24 are radially arranged in the top wall 23 of the top housing section 20 . The apertures 24 provide an inlet for permitting air to enter into an interior space of the wearable chemical dispenser 18 . A tab 26 provides a means to grasp the top housing section 20 when opening the top housing section 20 . [0060] The wearable chemical dispenser 18 also includes a slide cover 28 having an on-off button 29 , openings 31 , and a cam projection 32 . A fastener 34 (see FIG. 6 ) mounts the slide cover 28 to the top housing section 20 such that the slide cover 28 may rotate with respect to the top housing section 20 when a user moves the on-off button 29 along the side wall 22 of the top housing section 20 . In the ‘off’ position, the slide cover 28 closes the apertures 24 that are radially arranged in the top wall 23 of the top housing section 20 . In the ‘on’ position, the openings 31 of the slide cover 28 align with the apertures 24 that are radially arranged in the top wall 23 of the top housing section 20 . [0061] The wearable chemical dispenser 18 also includes a hinge bracket 36 that is mounted to an inner surface of the top housing section 20 as shown in FIG. 5 . The hinge bracket 36 has a flat base plate 37 that mounts to the top housing section 20 , a generally L-shaped arm 38 having an inwardly directed pivot pin 39 at its end, and generally L-shaped arm 40 having an inwardly directed pivot pin 41 at its end. The arm 38 and the arm 40 are spaced apart on the plate 37 as shown in FIGS. 5 and 6 . The hinge bracket 36 forms part of a hinge mechanism as described below. [0062] A replaceable refill unit 44 is provided with the wearable chemical dispenser 18 . The refill unit 44 has a generally slab-like support structure 45 . In top plan view, the refill unit 44 has an essentially tear-drop shaped overall appearance, with a generally circular portion at one end and a generally triangular portion at another end. There is a spoke support 47 across a circular opening through the refill unit 44 (see FIG. 5 ). Across the spoke support 47 is positioned a fabric substrate 48 . When air is drawn in, the air passes through the fabric substrate 48 . The choice of the fabric, and its porosity, the speed of the air flow, and the vapor pressure of the active, are the main factors in coordinating the speed of use up of the active with the speed of use up of a visual use-up cue 49 (see FIG. 5 ) that can be viewed through the slot 25 of the top housing section 20 . An example refill unit has a twelve hour life, and the visual use-up cue 49 is designed to evaporate or change in appearance after twelve hours. A suitable visual use-up cue is described in U.S. Patent Application Publication No. 2008/0141928. [0063] By impregnating the fabric substrate 48 with an appropriate air treatment chemical, air entering the device will pick up some of the volatile chemical, and dispense it out of the device. Active release rates of 0.2 milligrams per hour (mg./hr.) or higher are preferred. Particularly preferred actives are transfluthrin, prallethrin, vaporthrin, tefluthrin, and esbiothrin or other synthetic pyrethroids. For use in controlling mosquitoes, it is preferred to use metofluthrin from the Sumitomo Chemical Company (trade name SumiOne). The impregnation material can be pure active, or for ease of handling the material can be dissolved in a hydrocarbon or other solvent. Alternatively, or in addition, the fabric may also bear a fragrance, a deodorizer, or other air treatment chemical. It is preferred to have the fabric substrate 48 configured so that the pressure drop across the substrate is no more than 40 Pascals (Pa). Suitable fabrics can be made of woven or non-woven materials providing only minimal resistance to the airflow. [0064] The fabric substrate 48 should also be capable of holding active ingredient dosed onto the material and also allow ready migration of the active to the surface so as to allow its evaporation in response to the airflow. For an active ingredient that is hydrophobic and migrateable at common environmental temperatures between about 10° C. and 40° C. (e.g., metofluthrin), suitable materials include, only by way of example, polyester, polypropylene, cotton, cellulose, poly-rayon, and other similar fabrics. These can be non-wovens with basis weights ranging from 10 grams per square meter (gsm) to 40 grams per square meter (gsm), fabricated from synthetic, natural, or combined synthetic and natural polymeric materials. [0065] The ideal fabric substrate 48 should also allow for wicking of the active ingredient following dosing so as to ensure efficient distribution throughout the substrate, and thereafter allow migration of active ingredient to the substrate surface to replenish the active ingredient that is being evaporated by the passing airflow. Dosing may be by dropping, spraying, printing, or other conventional delivery of a liquid active ingredient to the substrate. A particularly desirable fabric is a non-woven felted material with a basis weight of 20-30 gsm fabricated from polyethylene terephthalate. [0066] A frame 50 is located below the refill unit 44 in the wearable chemical dispenser 18 . The frame 50 has a generally oblong perimeter, and supports the refill unit 44 (see FIGS. 5 and 6 ). Note that one side of the essentially triangular portion of the refill unit 44 is straight and the other is indented. This slight lack of symmetry is designed to accommodate a corresponding slight lack of symmetry along the top side of frame 50 , and to thereby prevent a consumer from installing the refill unit 44 inside-out on the frame 50 . One end of the frame 50 has a pair of slots 51 that form part of a hinge mechanism as described below. A circular opening 52 is provided at the other end of the frame 50 . Holes 54 in the frame 50 support a rotating activation button 56 that is biased by a rotary spring 57 into an off position. [0067] Looking at FIGS. 6 and 11 , there is shown a fan 60 of the wearable chemical dispenser 18 . The fan 60 has a rotor 61 having a central vertical wall 63 that joins a top central horizontal wall 64 . The central vertical wall 63 and the top horizontal wall 64 define a recess 65 in the bottom of the rotor 61 (see FIG. 7 ). The top horizontal wall 64 of the rotor 61 includes a tubular mounting element 66 on the axis of the rotor 61 . [0068] The preferred fan 60 includes fourteen fan blades 68 a to 68 n (see FIG. 11 ). It has been discovered that a fan configuration, which results in an ideal balance of airflow and minimal power consumption for the wearable chemical dispenser 18 , includes twelve to eighteen fan blades. Preferably, the fan produces an average volumetric flow rate of air of 1.5 to 3 cubic feet per minute (with the refill unit 44 installed) over the life (e.g., at least eight, and most preferably at least twelve hours) of a refill unit 44 . Typically, the fan will operate at 3000-5000 rpm. In one example wearable chemical dispenser 18 , over the life (e.g., twelve hours) of a refill unit 44 , the consumed power from the power supply is 0.35 watts or less, preferably 0.30 watts or less, more preferably 0.25 watts or less, and even more preferably 0.20 watts or less. In one example embodiment, over a twelve hour life of a refill unit 44 , the consumed power from the power supply is about 0.17 watts while maintaining an average volumetric flow rate of air of at least 1.5 cubic feet per minute over the twelve hour period. When using one or more batteries for the power supply, the voltage will vary during discharge. However, the power consumed can be determined from the total energy consumed divided by the total time. [0069] Each blade 68 a to 68 n has a generally rectangular body 69 defined by an inner edge 70 , an outer edge 71 , a top edge 72 extending from the inner edge 70 to the outer edge 71 , and top surface 73 of the rotor 61 . Looking at FIG. 11 , a radial reference line R 1 can be extended from a centerpoint C of the rotor 61 to the inner edge 70 of each blade 68 a to 68 n. Likewise, a radial reference line R 2 can be extended from a centerpoint C of the rotor 61 to the outer edge 71 of each blade 68 a to 68 n. The body 69 of each blade 68 a to 68 n forms an included angle A with its associated radial reference line R 1 . [0070] It has been discovered that a fan configuration, which results in an ideal balance of airflow and minimal power consumption for the wearable chemical dispenser 18 , includes a range of fan sizes and fan blade angles. Preferably, each blade 68 a to 68 n has a length extending from the inner edge 70 to the outer edge 71 in which the length measures 80% to 130% of the distance of radial reference line R 1 . Preferably, each blade 68 a to 68 n has a length extending from the inner edge 70 to the outer edge 71 in which the length measures 45% to 75% of the distance of radial reference line R 2 . Preferably, the included angle A in FIG. 11 , which is formed between the body 69 of each blade 68 a to 68 n and its associated radial reference line R 1 , is in the range of 100 to 150 degrees. These example fan sizes and fan blade angles contribute to an ideal balance of airflow and minimal power consumption for the wearable chemical dispenser 18 . Thus, among other things, the average volumetric flow rate of air from the fan depends on the outer radius of the rotor, the inner radius of the rotor, the number of blades, the blade angles, and the fan revolutions per minutes. [0071] One non-limiting example of the fan 60 has a length extending from the inner edge 70 to the outer edge 71 of about 15 millimeters, a radial reference line R 1 of about 14 millimeters, a radial reference line R 2 of about 25 millimeters, and an included angle A of about 120 degrees. In this non-limiting example, blade thicknesses can range from 0.3-1.0 millimeters, with 0.6 millimeters being preferred, and blade height (from the top surface 73 of the rotor 61 to the top edge 72 of the body 69 ) can range from 5-11 millimeters, with about 8 millimeters being preferred. [0072] The wearable chemical dispenser 18 includes an electrical power supply. In the example embodiment shown, a microswitch 75 of the power supply is electrically connected to battery contacts 76 . Another battery contact 77 completes an electrical circuit with batteries 78 and the battery contacts 76 to provide electricity to the microswitch 75 . When a user rotates the slide cover 28 by rotating the on-off button 29 into the ‘on’ position, the cam projection 32 of the slide cover 28 is driven into the rotating activation button 56 which then contacts the microswitch 75 to turn on the power supply. [0073] Looking at FIGS. 6-8 , the wearable chemical dispenser 18 includes a chassis 80 for mounting various components of the wearable chemical dispenser 18 . When the top housing section 20 and the chassis 80 are in a closed position (see, e.g., FIG. 1 ), a housing having an interior space is formed. The chassis 80 engages the frame 50 in a snap fit. [0074] The chassis 80 has a bottom wall 81 with a raised portion 82 that defines a upwardly directed space 83 in the chassis 80 (see FIGS. 6 and 7 ). A battery compartment 84 is also provided in the bottom wall 81 of the chassis 80 (see FIG. 7 ). The battery contacts 76 , 77 are mounted at opposite ends of the battery compartment 84 . Extending upward from the bottom wall 81 of the chassis 80 there is a hinge support 85 having a notch 86 and a hinge support 87 having a notch 88 (see FIGS. 6 and 8 ). The hinge support 85 and the hinge support 87 form part of a hinge mechanism as described below. [0075] The chassis 80 also includes a side wall 90 having regularly spaced openings 91 that define an outlet for permitting air mixed with air treatment chemical to exit the interior space of the wearable chemical dispenser 18 . In the non-limiting example embodiment shown in FIG. 5 , the openings 91 extend from point E to point F around the side wall 90 of the chassis 80 . In FIG. 5 , the included angle between point E and point F and point D (which is on axis X shown in FIG. 6 ) is about 270 degrees. Therefore, the openings 91 are regularly spaced around 270 degrees of the side wall 90 of the chassis 80 . Preferably, the openings 91 are regularly spaced around at least 180 degrees of the side wall 90 of the chassis 80 . More preferably, the openings 91 are spaced around at least 235 degrees of the side wall 90 of the chassis 80 . One non-limiting example of the total outlet area of the openings 91 is 8.5×10 −4 m 2 . Advantageously, the battery compartment 84 is isolated from the openings 91 . These example opening configurations contribute to an ideal balance of airflow and minimal power consumption for the wearable chemical dispenser 18 . [0076] Preferably, a flow path from the fan to the openings 91 is unobstructed. Some other devices included a slide cover designed to shut off air flow by blocking the inlet vents and the exhaust vents. The intent was to minimize loss of actives while the unit is not in use by blocking off airflow across the dosed pad. The walls blocking the exhaust vents and the geometries supporting them occupied large space and caused the device to increase in size. These blocking walls are eliminated in the present invention without increased loss in actives ingredient. [0077] A motor 93 is positioned in the space 83 in the chassis 80 , and a wire 94 connects the motor 93 to the microswitch 75 for powering the motor when the rotating activation button 56 contacts the microswitch 75 to turn on the power supply. The motor 93 includes a drive shaft 95 that is connected to the tubular mounting element 66 on the rotor 61 . As a result, the motor 93 can rotate the fan 60 . A battery door 96 covers the battery compartment 84 in the bottom wall 81 of the chassis 80 . The battery door 96 includes mounting tabs 97 . A bottom cover 102 is fastened to the chassis 80 by way of fasteners. [0078] Looking now at FIGS. 6 , 9 and 10 , means for clipping the wearable chemical dispenser 18 to a user's clothing (e.g., a belt) are shown. The bottom cover 102 includes a throughhole 103 partially surrounded by an arcuate well 104 in a bottom surface 105 of the bottom cover 102 . The bottom surface 105 of the bottom cover 102 further includes five spaced apart oblong depressions 106 a, 106 b, 106 c, 106 d, 106 e arranged in a semicircle around the throughhole 103 . The wearable chemical dispenser 18 also includes a clip 110 having a front section 112 that is spaced at its upper end from a rear section 113 by a top section 114 that connects the front section 112 and the rear section 113 . At the lower end of the clip 110 , the front section 112 and the rear section 113 are in contact until flexed apart by a user. The rear section 113 of the clip 110 has an arcuate projection 116 , a tubular mounting element 117 , and a movable tab 119 having a protrusion 120 on its end. The movable tab 119 is formed by a cutout 121 in the rear section 113 of the clip 110 . A fastener 122 (see FIG. 6 ) is inserted through the throughhole 103 of the bottom cover 102 and into the tubular mounting element 117 of the clip 110 to connect the bottom cover 102 and the clip 110 . [0079] Still looking at FIGS. 6 , 9 and 10 , a rotation feature of the clip 110 can be explained. When the clip 110 is connected to the bottom cover 102 , the clip 110 is positioned as in FIG. 9 . The fastener 122 secures the tubular mounting element 117 of the clip 110 in the throughhole 103 of the bottom cover 102 such that the clip 110 can rotate with respect to the bottom cover 102 . When the clip 110 is rotated clockwise from its position shown in FIG. 9 , the arcuate projection 116 moves in the arcuate well 104 in a clockwise direction thereby guiding rotation of the clip 110 . The protrusion 120 of the movable tab 119 moves out of the depression 106 c by way of flexing of the movable tab 119 . The clip 110 rotates clockwise until the protrusion 120 of the movable tab 119 moves into the depression 106 b of the bottom cover 102 . When the clip 110 is further rotated clockwise from the position in which the protrusion 120 is in the depression 106 b, the arcuate projection 116 moves further clockwise in the arcuate well 104 , and the protrusion 120 moves out of the depression 106 b by way of flexing of the movable tab 119 . The clip 110 rotates clockwise until the protrusion 120 of the movable tab 119 moves into the depression 106 a of the bottom cover 102 . When in this position, the arcuate projection 116 is prevented from moving further clockwise by wall 129 of the arcuate well 104 , and the housing of the wearable chemical dispenser 18 is at 90 degrees in relation to the clip 110 . [0080] When the clip 110 is rotated counterclockwise from its position shown in FIG. 9 , the arcuate projection 116 moves in the arcuate well 104 in a counterclockwise direction thereby guiding rotation of the clip 110 . The protrusion 120 of the movable tab 119 moves out of the depression 106 c by way of flexing of the movable tab 119 . The clip 110 rotates counterclockwise until the protrusion 120 of the movable tab 119 moves into the depression 106 d of the bottom cover 102 . When the clip 110 is further rotated counterclockwise from the position in which the protrusion 120 is in the depression 106 d, the arcuate projection 116 moves further counterclockwise in the arcuate well 104 , and the protrusion 120 moves out of the depression 106 d by way of flexing of the movable tab 119 . The clip 110 rotates counterclockwise until the protrusion 120 of the movable tab 119 moves into the depression 106 e of the bottom cover 102 . When in this position, the arcuate projection 116 is prevented from moving further counterclockwise by wall 127 of the arcuate well 104 , and the housing of the wearable chemical dispenser 18 is at 90 degrees in relation to the clip 110 . [0081] Thus, the arcuate projection 116 and the arcuate well 104 provide a means for controlled rotation of the clip 110 with respect to the bottom cover 102 . Specifically, the projection 116 moves in the well 104 when rotating the clip 100 . In the example embodiment of FIG. 9 , the well 104 and the projection 116 are dimensioned such that the clip 110 can rotate 180 degrees (i.e., 90 degrees clockwise and 90 degrees counterclockwise). Preferably, the clip 110 can rotate at least 90 degrees. [0082] In addition, the movable tab 119 with the protrusion 120 and the spaced apart oblong depressions 106 a, 106 b, 106 c, 106 d, 106 e arranged in a semicircle around the throughhole 103 provide a means for indexed rotational positioning of the clip 100 and the housing relative to each other. The depressions 106 a, 106 b, 106 c, 106 d, 106 e provide a guide and the protrusion 120 of the movable tab 119 travels stepwise in the guide as explained above. [0083] Often a user will clip the wearable chemical dispenser 18 to a belt with the clip 110 of the wearable chemical dispenser 18 in the position shown in FIG. 9 wherein the outlet openings 91 face down from, to one side, and to the opposite side of the user. This directs a mixture of air and air treatment chemical down from, to one side, and to the opposite side of the user. If a user wishes to direct the mixture of air and air treatment chemical up, down, and to one side, the user can rotate the housing using the rotating clip 110 as described above. A user may also wish to rotate the housing in order to avoid any pinching against the body when sitting. Also, by locating a pivot point of the clip 110 in a section of the housing adjacent the outlet openings 91 , more precise control of the direction of the mixture of air and air treatment chemical is afforded when rotating the clip 110 . Thus, the housing of the wearable chemical dispenser 18 can be vertical or horizontal when in use. [0084] Turning now to FIGS. 5 , 6 , 8 , 8 A, 8 B, and 8 C, the hinge mechanism of the wearable chemical dispenser 18 can be described further. The hinge mechanism allows a user to open the top housing section 20 to the open position of FIGS. 5 , 7 and 8 A so that a new refill unit 44 can be installed on the frame 50 as shown in FIG. 5 . [0085] Looking at FIGS. 8A , 8 B and 8 C, movement of the pivot pin 39 of the hinge arm 38 in the notch 86 of the hinge support 85 can be explained. The pivot pin 39 has an outer wall 131 having an arcuate section 132 that extends between a first flat section 133 and a second flat section 134 . An intermediate section 135 connects the first flat section 133 and the second flat section 134 . Although FIGS. 8A , 8 B and 8 C do not show the pivot pin 41 , the pivot pin 41 has an outer wall with the same shape as outer wall 131 of pivot pin 39 . [0086] In FIG. 8A , the top housing section 20 is in a fully open position. The second flat section 134 of the outer wall 131 of the pivot pin 39 rests on a bottom flat surface 137 (see FIG. 8 ) of the notch 86 of the hinge support 85 . The mating of the bottom flat surface 137 of the notch 86 and the second flat section 134 of the outer wall 131 of the pivot pin 39 keeps the top housing section 20 in the fully open position. [0087] In FIG. 8C , the top housing section 20 is in a closed position. The first flat section 133 of the outer wall 131 of the pivot pin 39 rests on the bottom flat surface 137 of the notch 86 of the hinge support 85 . The mating of the bottom flat surface 137 of the notch 86 and the first flat section 133 of the outer wall 131 of the pivot pin 39 keeps the top housing section 20 in the closed position. Also, a catch 155 (see FIG. 5 ) of the top housing section 20 engages a slot 157 (see FIG. 5 ) to keep the housing closed. [0088] In FIG. 8B , the top housing section 20 is in a partially open position. The intermediate section 135 of the outer wall 131 of the pivot pin 39 rests on the bottom flat surface 137 of the notch 86 of the hinge support 85 . The mating of the bottom flat surface 137 of the notch 86 and the intermediate section 135 of the outer wall 131 of the pivot pin 39 tends to keep the top housing section 20 in the partially open position. However, movement of the top housing section 20 in direction Z will cause the top housing section 20 to quickly return to the fully open position shown in FIG. 8A as pivot pin 39 will rotate due to gravity until the second flat section 134 of the outer wall 131 of the pivot pin 39 rests on a bottom flat surface 137 of the notch 86 . In contrast, movement of the top housing section 20 in direction Y will cause the top housing section 20 to move to the closed position shown in FIG. 8C as pivot pin 39 will rotate due to gravity until the first flat section 133 of the outer wall 131 of the pivot pin 39 rests on a bottom flat surface 137 of the notch 86 . [0089] The pivot pin 41 moves in the notch 88 in a similar manner with flat sections of the outer wall of the pivot pin 40 resting on the bottom flat surface 138 (see FIG. 8 ) of the notch 88 of the hinge support 87 during opening of the top housing section 20 . During movement of the hinge, the arm 38 and the arm 40 of the hinge bracket 36 move in the slots 51 of the frame 50 (see FIG. 5 ). [0090] The configuration of the outer wall of the pivot pins 39 , 41 of the arms 38 , 40 of the hinge bracket 36 provides an advantageous hinging action when opening the top housing section 20 . When a user first begins to open the top housing section 20 , the user must overcome the tendency of the pivot pins 39 , 41 to return to the closed position where the first flat section of the outer wall of the pivot pin rests on a bottom flat surface of the associated notch (see FIG. 8C ). However, once the top housing section 20 has reached the partially open position of FIG. 8B , a small amount of further movement in direction Z will cause the top housing section 20 to quickly move to the fully open position shown in FIG. 8A as pivot pin 39 will rotate due to gravity until the second flat section 134 of the outer wall 131 of the pivot pin 39 rests on a bottom flat surface 137 of the notch 86 . [0091] Likewise, the configuration of the outer wall of the pivot pins 39 , 41 of the arms 38 , 40 of the hinge bracket 36 provides an advantageous hinging action when closing the top housing section 20 . When a user first begins to close the top housing section 20 , the user must overcome the tendency of the pivot pins 39 , 41 to return to the fully open position where the second flat section of the outer wall of the pivot pin rests on a bottom flat surface of the associated notch (see FIG. 8A ). However, once the top housing section 20 has reached the partially open position of FIG. 8B , a small amount of further movement in direction Y will cause the top housing section 20 to quickly move to the closed position shown in FIG. 8C as pivot pin 39 will rotate due to gravity until the first flat section 133 of the outer wall 131 of the pivot pin 39 rests on a bottom flat surface 137 of the notch 86 . [0092] Regarding component construction, the top housing section 20 , slide cover 28 , hinge bracket 36 , support structure 45 of the refill unit 44 , frame 50 , fan 60 , chassis 80 , battery door 96 , bottom cover 102 , and clip 110 may be formed from a suitable polymeric material such as polyethylene, polypropylene, or polyester. [0093] In operation, the wearable chemical dispenser 18 will be clipped on a belt, purse or the like using clip 110 for that purpose. When a user moves the on-off button 29 along the side wall 22 of the top housing section 20 into the ‘on’ position, the openings 31 of the slide cover 28 align with the apertures 24 that are radially arranged in the top wall 23 of the top housing section 20 . The cam projection 32 of the slide cover 28 is driven into the rotating activation button 56 which then contacts the microswitch 75 to turn on the power supply to power the fan 60 by way of motor 93 . Air is sucked by the fan 60 of the wearable chemical dispenser 18 in through apertures 24 and the openings 31 . As the air passes through fabric substrate 48 , the air treatment chemical mixes into the air and a mixture of air and air treatment chemical is then blown radially out openings 91 (preferably down along pants or dresses). A user can rotate the clip 110 as described above. [0094] While the present device is primarily intended to be used as a wearable item carried with a human when outdoors, it can also be laid flat, with the clip 110 downward and the top housing section 20 upward, on a picnic table or the like. When used in this manner it can provide protection to an area during a picnic or similar outdoor activity. [0095] Hence, the device is much more compact and lightweight, yet still effective. Further, the cost of operation from a battery standpoint is reduced. The device can more comfortably be used when seated, and provides greater control over dispensing direction. Also, installing a replacement active refill is easier. These advantages are achieved at lowered cost, and provide a reliable construction. [0096] In the wearable dispenser, the intake grill size is designed to work in concert with an improved fan which falls within a specific range of fan blades, size and blade angle. A low current draw motor is recessed into the axial hub of the fan design. The airflow exits through 270 of output vents. This combination of design features results in an ideal balance of airflow and minimal power consumption that results in a highly efficient system, which produces good insect repellency and usage duration in a relatively small, lightweight unit. [0097] While an example embodiment has been described above, it should be appreciated that there are numerous other embodiments of the invention within the spirit and scope of this disclosure. For example, the device can be powered by a different source of energy (e.g. a solar power panel), other forms of actives can be dispensed along with or in substitution for the insect control ingredients (e.g. a fragrance or deodorizing chemical), and even when an insect control ingredient is dispensed it need not be one focused on controlling mosquitoes (e.g. chemicals for repelling other flying or crawling insects or pests can be used). Hence, the invention is not to be limited to just the specific embodiments shown or described. INDUSTRIAL APPLICABILITY [0098] Provided herein are wearable dispensing devices capable of dispensing insect control chemicals and/or other air treatment chemicals adjacent a human body.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to the fields of immunology and tumor biology. More specifically, the present invention relates to treatment for the enhancement of CD38 protein expression in target tumor cells to increase the cytotoxicity of anti-CD38 based immunotoxins. 2. Description of the Related Art The use of monoclonal antibodies for delivering drugs or toxins to distinct molecular structures expressed on the surface of unwanted tumor cells represents an attractive and potentially useful strategy. Theoretically, such a targeted approach to cancer therapy could offer a major advance in the selective elimination of tumor cells while reducing the toxicity of treatment towards normal non-target tissues. Nevertheless, in practice many problems exist that need to be addressed before immunotoxin or antibody-drug therapies can be truly effective in vivo. One potential limitation to the success of any targeted approach to therapy is the heterogeneity of target antigen expression within a population of tumor cells. It follows that if a small number of cells within a tumor were negative for the target antigen or expressed the antigen only very weakly, then these cells could possibly escape destruction due to a failure of antibody-mediated delivery of the cytotoxic agent to those particular cells. A possible means of overcoming this problem would be to identify agents that induce high levels of cell surface target molecules, in the expectation that target tumor cells which were antigen negative would express these target molecules in abundance. All-trans-retinoic acid (RA) is an agent that induces high levels of CD38 cell surface antigen expression in several myeloid and lymphoid leukemia cells. Retinoic acid-induced expression of CD38 in these cells is specific, rapid, dose-dependent, and highly sensitive, with 4-fold induction at as low a dose of retinoic acid as 10 −13 M. The induction of CD38 expression by retinoic acids has been shown to involve the RARα retinoid receptor. RAR receptors form heterodimers with RXR receptors; the RXR/RAR heterodimer then interacts with DNA sequences known as retinoic acid response elements (RARE's) which are involved in retinoid-induced transcription. CD38 is a 45-kDa cell surface protein which is primarily expressed by early progenitor and mature activated cells of the hematopoetic system. It is a transmembrane glycoprotein with a short N-terminal cytoplasmic domain and a long C-terminal extracellular domain. The extracellular domain has been shown to be a bifunctional enzyme having ADP-ribosyl cyclase as well as ADP-ribosyl hydrolase activities in that it catalyzes the conversion of NAD+ to cADPR (cyclase) and can further hydrolyze it to ADP-ribose (hydrolase). cADPR is involved in the mobilization of calcium from intracellular stores which is a second messenger activity important for cellular proliferation, differentiation, and apoptosis. CD38 is believed to act as a receptor for an unidentified ligand and to act as a cell adhesion molecule by interacting with CD31. Experiments in which CD38 function was activated by monoclonal antibodies directed against it have implicated CD38 in proliferation of mature B lymphocytes and myeloid leukemia cells, rescue of germinal center cells from apoptosis, and growth suppression of stroma-supported cultures of B-cell progenitors as well as induction of the cytokines IL-6, IGN-g, GM-CSF, and IL-10. In addition, it has been shown to signal an increase in TNF-α, IL-1, IL-6, and IL-8 transcription in myeloid leukemia cells. The prior art is deficient in the lack of a method to induce the expression of a target molecule for immunotherapy of tumor and other disease-causing cells. The present invention fulfills this longstanding need and desire in the art. SUMMARY OF THE INVENTION The present invention demonstrates the potential of retinoid-induced CD38 expression to serve as a target for delivering the immunotoxin anti-CD38-gelonin. The results obtained suggested that retinoic acid treatment of leukemia cells, even at very low concentrations (subnanomolar) makes these cells exquisitely sensitive to immunotoxin-induced killing. The current invention comprises a method of treating an individual having a pathophysiological state, comprising the step of administering to said individual a pharmacologically effective dose of an agent which upregulates the expression of a cellular target and also administering a pharmacologically effective dose of an immunotoxin directed against the upregulated cellular target. The current invention also comprises a method of treating an individual having a pathophysiological state responsive to retinoid treatment, comprising the step of administering to said individual a pharmacologically effective dose of a retinoic acid metabolite and a pharmacologically effective dose of an immunotoxin. Other and further aspects, features, and advantages of the present invention will be apparent from the following description of the presently preferred embodiments of the invention. These embodiments are given for the purpose of disclosure. BRIEF DESCRIPTION OF THE DRAWINGS So that the matter in which the above-recited features, advantages and objects of the invention, as well as others which will become clear, are attained and can be understood in detail, more particular descriptions of the invention briefly summarized above may be had by reference to certain embodiments thereof which are illustrated in the appended drawings. These drawings form a part of the specification. It is to be noted, however, that the appended drawings illustrate preferred embodiments of the invention and therefore are not to be considered limiting in their scope. FIG. 1 shows a dot blot of mRNA from a variety of human tissues after hybridization with a radiolabeled human CD38-specific nucleic acid probe. Relatively low CD38 mRNA expression was observed only in thymus tissue [from both adult (E5) and fetal (G6)] while a lesser level of expression was seen in normal prostate (C7). FIG. 2 shows the effects of 5 nM all-trans-retinoic acid (RA) on the cytotoxicity of the immunotoxin and the effects of adding increasing concentrations of the unconjugated anti-CD38 monoclonal antibody (IB4). Point C indicates the effect of immunotoxin alone. +IT (+RA) shows the effect of 5 nM all-trans-retinoic acid (RA) on the cytotoxicity of the immunotoxin. In the rest of the samples, increasing concentrations of IB4 were added along with immunotoxin and 5 nM all-trans-retinoic acid (RA). After 3 days of incubation, cell viability was determined with the MTS assay. The results are represented in terms of % surviving cells. FIG. 3 shows effect of retinoic acid pretreatment on the cytotoxicity of anti-CD38 immunotoxin on HL-60 cells. HL-60 cells were incubated overnight in the presence or absence of retinoic acid. After removal of the media and twice washing the cells, the cells were reincubated with increasing concentrations of immunotoxin (represented as ng/well) in the presence or absence of 100-fold excess of unconjugated anti-CD38 monoclonal antibody IB4. After three days, the MTS assay was used to determine cell viability which is represented in terms of % surviving cells. FIG. 4 shows the effect of treatment with either immunotoxin or gelonin on the viability of HL-60 cells. HL-60 cells were incubated for three days in increasing concentrations of either immunotoxin or gelonin (represented as ng/well toxin) in the presence or absence of 5 nM retinoic acid. Cell viability was determined by the MTS assay and is represented here in terms of percent cell survival relative to the control sample (no toxin). FIG. 5 shows the effect of increasing concentrations of all-trans-retinoic acid (RA) (in nM) on cell survival. HL-60 cells were incubated with either immunotoxin or unconjugated anti-CD38 monoclonal antibody in either the absence or the presence of increasing concentration of retinoic acid (shown in nM). After three days, cell viability was determined by MTS assay and is shown in terms of percentage of cell survival relative to an untreated control. FIG. 6 shows the effect of increasing concentrations of immunotoxin (shown in ng/well) in either the presence or absence of 5 nM all-trans-retinoic acid (RA) on cell survival of different cell lines including (Daudi, THP-1, K562 (which is resistant to RA-induced expression of CD38), and a RARα-expressing variant of HL60. Cell viability was measured by the MTS assay after three days and is represented in terms of percent cell survival relative to an untreated control. FIG. 7 shows the immunotoxin induced killing of Doxo-resistant HL-60 cells which are resistant to adriamycin-induced killing. The cells were incubated with increasing concentrations of immunotoxin (shown in ng/well) in either the presence or absence of 5 nM RA. Cell survival was assayed after 3 days using the MTS assay. FIG. 8 shows the immunotoxin mediated killing of the non-Hodgkin lymphoma cell line MZ(NHL) that has a high basal expression of CD38 antigen. The cell were incubated with increasing concentrations of immunotoxin (shown in ng/well) in the presence or absence of 5 nM retinoic acid. After three days, cell viability was assayed with the MTS assay and is shown in terms of % viable cells. FIG. 9 shows the immunotoxin mediated killing of the retinoic acid-resistant variant of the HL60 cell line (HL60R). These cells are resistant to retinoic acid-induced expression of the CD38 antigen due to a point mutation in the retinoic acid receptor alpha (RARα) gene. The cell line was cultured with increasing concentrations of immunotoxin (in ng/ml) under different conditions. After 3 days, cell viability was assayed by the MTS assay and is represented in terms of O.D. The presence of retinoic acid failed to promote immunotoxin-induced killing of these cells due to their inability to express CD38 antigen in response to retinoic acid treatment. DETAILED DESCRIPTION OF THE INVENTION An immunotoxin is defined as any immunological molecule such as an antibody which has been conjugated with a toxin, preferably a cytotoxin. The present invention is directed to a method of treating an individual having a pathophysiological state, comprising the step of administering to said individual an a pharmacologically effective dose of an agent which upregulates the expression of a cellular target. This administration is followed by the administration of a pharmacologically effective dose of an immunotoxin directed against the cellular target. Preferably, the administered agent is selected from the group consisting of differentiating agents, cytokines, interleukin-2, tumor necrosis factor, interferon-α, interferon-γ and peptide hormones. In one embodiment, the invention comprises the administration of a pharmacologically effective dose of a retinoid. Preferably, the retinoid induces expression of CD38 antigen in cells. If this is the case, a pharmacologically effective dose of a anti-CD38 immunotoxin is administered. Representative pathophysiological states which may be treated using the methods of this embodiment of the invention include RARα selective acute myeloid leukemia, acute promyelocytic leukemia, lymphomas, and myelomas. Representative retinoic acid metabolites which may be used in the methods of the present invention include all-trans-retinoic acid (RA); 9-cis retinoic acid (9-cis RA); (E)-4-[2-(5,6,7,8-tetrahydro-5,5,8,8-tetramethyl-2-naphthalenyl)-1-propenyl]benzoic acid (TTNPB); (E)-4-[2-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)-1-propenyl]benzoic acid (3-met TTNPB); and other retinoids that can bind and activate the RARα receptor. Preferably, the retinoid is administered in a dose of from about 0.1 mg/kg to about 2 mg/kg. The immunotoxin used in the methods of the present invention specifically target cells expressing the CD38 antigen. Preferably, the immunotoxin comprises a monoclonal antibody directed against the CD38 antigen conjugated to a toxin molecule. Although a person having ordinary skill in this art could substitute any toxin, a preferred toxin useful in these methods is gelonin. Although a person having ordinary skill in this art could substitute any monoclonal antibody specific for the CD38 antigen, IB4 or IB6 antibodies were used herein to demonstrate the present methods. Preferably, the immunotoxin is administered in a dose of from about 0.05 mg/kg to about 2 mg/kg. The following examples are given for the purpose of illustrating various embodiments of the invention and are not meant to limit the present invention in any fashion. EXAMPLE 1 CD38 Expression in Normal Tissues is Limited Mainly to the Thymus. The tissue specificity of CD38 was examined by the hybridization of a radiolabeled CD38 nucleic acid probe against a commercial (CLONTECH) tissue specific mRNA dot blot. The results of the hybridization are shown in FIG. 1 . It was observed that CD38 is mainly expressed in the thymus with significantly lower levels of expression in the prostate. EXAMPLE 2 Retinoic Acid (RA) Augments the Cytotoxic Effect of Immunotoxin Through Enhanced Expression of CD38. HL-60 cells were incubated with either immunotoxin alone or in the presence of 5 nM retinoic acid (RA). Increasing concentrations of unconjugated IB4 monoclonal antibody were added to the cells incubated with immunotoxin and retinoic acid. After three days, the cells were assayed for viability with the MTS assay. Briefly, 6.5 mg/ml MTS solution [(3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium] and 0.5 mM PMS (phenazine methosulfate) solution were mixed at a ratio of 20:1. 20 μl of the combined MTS/PMS solution was placed in each well of a 96 well plate containing samples of the cells to be tested. The plate was incubated for 1–4 hours at 37° C. in a 5% CO 2 atmosphere, after which time, the amount of formazan produced by live cells from cellular reduction of MTS was measured by reading the absorbance at 490 nm. The results are shown in FIG. 2 . Immunotoxin alone had little effect on the viability of the cells (C). However, when the cells were incubated with immunotoxin in the presence of 5 nM retinoic acid, a significant reduction in cell viability was observed. Increasing concentrations of unconjugated IB4 monoclonal antibody blocked the cytotoxic effect of immunotoxin and retinoic acid. The fact that unconjugated IB4 blocked the ability of the immunotoxin to kill the cells demonstrates that the immunotoxin is specifically interacting with the CD38 surface marker and that the effect of the retinoic acid is to increase the expression of the CD38 antigen. EXAMPLE 3 All-Trans-Retinoic Acid (RA) Pretreatment Enhances the Induced Killing of HL-60 Cells. HL-60 cells were preincubated overnight in either the presence or absence of 5 nM all-trans-retinoic acid. The cells were washed twice and incubated in increasing concentrations of immunotoxin in either the presence or absence of IB4 unconjugated anti-CD38 MoAb. After three days, the cell were assayed for viability. The results are shown in FIG. 3 . Preincubation with all-trans-retinoic acid followed by immunotoxin treatment resulted in more cell death than treatment with immunotoxin alone. The presence of 100 fold excess of the unconjugated anti-CD38 monoclonal antibody IB4 blocked the toxicity of the immunotoxin in both cases by competing with the immunotoxin for access to the CD38 markers on the cells. These results demonstrate that the all-trans-retinoic acid (RA) was causing some change in the cells which render them more susceptible to the immunotoxin rather than playing a direct role in the death of the target cells. EXAMPLE 4 Gelonin must be Conjugated to the Anti-CD38 Antibody to have a Toxic Effect on the Target Cells. HL-60 cells were incubated for three days with increasing concentrations of either immunotoxin or gelonin in either the presence or absence of 5 nM retinoic acid. Afterwards, the cells were assayed for viability using the MTS assay. As seen in FIG. 4 , gelonin alone had no toxic effect in either the presence of absence of 5 nM. Thus, the toxic effect of gelonin depends on it being conjugated to the anti-CD38 monoclonal antibody in order to deliver the toxin to the cell. EXAMPLE 5 Even Nominal Levels of All-Trans-Retinoic Acid (RA) Lead to Increased Toxicity of the Immunotoxin. HL-60 were incubated with either immunotoxin or unconjugated IB4 monoclonal antibody in increasing concentrations of monoclonal antibody. FIG. 5 shows that even the lowest level of all-trans-retinoic acid (RA) (1 nM) lead to almost complete killing of the target cells by the immunotoxin. This effect was not observed with the unconjugated monoclonal antibody. This result indicates that it is the gelonin conjugated to the monoclonal antibody in the immunotoxin that leads to the increased cell death rather than some effect of the antibody itself. EXAMPLE 6 Retinoic Acid can Induce Expression of the CD38 Marker in a Variety of Cell Lines. The Daudi, THP-1, K562, and HL60-RARα cell lines were treated with increasing concentrations of immunotoxin in either the presence or absence of 5 nM all-trans-retinoic acid (RA). After three days, the viability of the cells was examined using the MTS assay, which is shown in FIG. 6 . In the THP-1 and HL60-RARα cell lines, all-trans-retinoic acid induced cell death while the cell which were cultured in the absence of all-trans-retinoic acid were mostly unaffected by the immunotoxin. In the Daudi cells, which have a high basal expression of CD38, the immunotoxin resulted in almost complete cell death regardless of whether retinoic acid was present. On the other hand, K562, which are resistant to RA-induced CD38 expression, were unaffected by the immunotoxin regardless of the presence of retinoic acid. EXAMPLE 7 Immunotoxin Induced Cell Death in HL-60 Cells Resistant to Adriamycin. HL-60 subcloned cells, resistant to adriamycin-induced killing were cultured with immunotoxin either alone or in the presence of 5 nM all-trans-retinoic acid. After three days, the MTS assay was used to test cell viability. FIG. 7 shows the results obtained. Some cell death was observed in the presence of immunotoxin alone which was greatly augmented by the addition of 5 nM all-trans-retinoic acid. EXAMPLE 8 Cells which have High Basal Expression of CD38 are Killed by Immunotoxin Regardless of the Presence or Absence of All-Trans-Retinoic Acid (RA). MZ, a non-Hodgkin lymphoma cell line which has a high basal expression of CD38, was treated with increasing amounts of immunotoxin in either the presence or absence of 5 nM all-trans-retinoic acid. The addition of immunotoxin resulted in a high level of cell death regardless of the presence or absence of retinoic acid ( FIG. 8 ). This is strong evidence that retinoic acid is increasing the toxicity of immunotoxin by enhancing the level of CD38 on other cell lines which do not have a high basal level of CD38. EXAMPLE 9 Retinoic Increases CD38 Expression in a Number of Lymphoid Tumor Cells. Table I lists the potential targets for anti-CD38 bound toxin treatment A number of different lymphoid tumor cell lines were treated with 5 nM all-trans-retinoic acid (RA). Afterwards, the expression of CD38 in untreated versus treated cell was measured by flow cytometry. A significant rise in CD38 expression was observed in acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), lymphoma, and myeloma tumor cells. The increase in CD38 expression ranges from 2.5 to 20 fold. Thus, retinoic acid can be used in all of these tumor types to increase the vulnerability of the tumor cells to immunotoxin treatment. EXAMPLE 10 Immunotoxin does not Affect Cells Resistant to All-Trans-Retinoic Acid (RA) HL-60 cells with a mutated RARα gene that renders the cells resistant to the effects of retinoic acid were treated with immunotoxin in either the presence or absence of 5 nM retinoic acid. In these cells, the addition of retinoic acid had no effect on the toxicity of the immunotoxin. As shown in FIG. 9 , no appreciable cell death was observed in the cells treated with all-trans-retinoic acid (RA), with unconjugated IB4 and gelonin, or with gelonin alone. This is further proof that the immunotoxin kills cells which are affected by retinoic acid because of a retinoid induced increased in expression of CD38 target of the immunotoxin. Any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. These patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The present examples along with the methods, procedures, treatments, molecules, and specific compounds described herein are presently representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the invention. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention as defined by the scope of the claims. TABLE 1 Potential targets for anti-CD38 bound toxin treatment Cell target Basal CD38 CD38 after RA treatment AML 50 ± 10 180 ± 20 APL  6 ± 4 120 ± 30 Lymphomas 80 ± 20 210 ± 10 Myelomas 60 ± 20 180 ± 25 SLE Myesthenia {close oversize bracket} B cells producing self reactive ab gravis Rheumatoid arthritis Self reactive T lymphocyte Organ Transplantation

1a

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0001] This invention was developed and/or researched using federal government funds under NIH Contract #______. CROSS REFERENCE TO RELATED APPLICATIONS [0002] Not applicable. NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT [0003] Not applicable. BACKGROUND [0004] 1. Field of the Invention [0005] This invention relates to a compact scanner assembly with a resonant scanner and two galvanometer scanners for multi region of interest (mroi) imaging and targeting of intact tissue. [0006] 2. Background of the Invention [0007] Two-photon laser scanning microcopy (2PLSM) is a method for high-resolution, three-dimensional imaging in intact tissue. For the past 2 decades, 2PLSM has enabled celllar resolution in vivo brain imaging [ ]. Within the last decade, experimental approaches and molecular tools have advanced to allow robust observation of cellular-resolution brain activity in awake behaving animals, such as: navigation in virtual reality environments, active motion, controlled sensory input, complex behavioral tasks, and measurable animal learning [ . . . ]. [0008] The cerebral cortex is widely understood to be organized into columns of 300-600 μm in diameter 1-4 . Information in the brain is distributed and transformed across cortical columns and areas ( FIG. 1 a ). Such coordination between brain regions can be increasingly correlated to specific and measurable animal behavior, such as the coordination of contralateral cortical premotor regions in preparing a unilateral motion 5 . [0009] Full understanding of information processing in the brain requires cellular resolution activity mapping of two or more interacting cortical columns during specific behaviors. But today's widely used 2PLSM optics and objectives reach fields-of-view (FOV) of only up to ˜500 μm diameter, i.e. corresponding to the size of a single cortical column. Newly reported wide-FOV scanning optics are more than doubling the scanned area with current-day objectives (to >1 mm diameter); and new wide-FOV objectives are expanding the area even further, reaching up to 3.5 mm diameter 6 . These field sizes span beyond individual and adjacent columns to cover much broader cortical regions—indeed nearly the entire visual cortex of the mouse brain. [0010] These new optics provide an exciting avenue to allow large-scale optical recordings of neural activity in multiple cortical regions concurrently. But a key additional development is required to maintain both imaging speed and signal quality comparable to today's optical recordings, across such wider FOVs. Imaging must be targeted to specific cortical regions-of-interest (ROIs), in order to ensure that neither laser scanning time, nor the proportional signal integration time, is wasted by imaging across large intervening areas not under study. [0011] Market Outlook and Commercialization [0012] Certain software products are widely used for 2PLSM applications in neurobiology ( FIG. 2 ), such as for example Vidrio Technologies ScanImage software product. Market research indicates there are at least 1000 2PLSM systems worldwide for cellular brain imaging, with approximately 100 new scope systems being sold each year. Thus, there is a great need for these products in the marketplace. Market interest is accelerating due to great advances in molecular indicators 7 that are narrowing the gap in spike sensitivity and signal fidelity compared to electrical recordings. Numerous researchers previously focused exclusively on electrical recording approaches are switching to or adding optical recording techniques to their toolkit. The vast majority of deployed 2PLSM systems are galvo-galvo (GG) scanner systems. Because of the speed, signal and specimen quality, and motion tolerance benefits of resonant scanning 8,9 , the majority of these users have a strong desire to benefit by upgrading to an RG raster scanning system. SUMMARY OF THE INVENTION [0013] We provide the alternative of Multi-ROI (MROI) Imaging which combines raster scanning with random-access scanning, to target multiple geometric ROIs, e.g. rectangular, linear, 3-D spaces, for imaging ( FIG. 1 b ). MROI imaging employs a combination of scanner components: one resonant scanner and two galvanometer (galvo) scanners, arranged sequentially within a single scanner assembly (RGG). [0014] MROI imaging based on RGG scanner hardware can be retrofitted into existing 2PLSM systems to reach wide 1 mm FOV diameters, provided that a compact assembly with sufficient size and angular range is designed and produced (Aspect 1). Dedicated MROI imaging system software will coordinate targeted scanning in each plane with an axial sweep, allowing simultaneous optical recordings from neural ensembles (>100) in multiple volume ROIs at >4 Hz (Aspect 2; FIG. 1 c ). [0015] Phase 2 work adapting MROI imaging to wider-FOV objectives requires a more optimized optical design 6 , forming a complementary hardware option to the compact design achieved in Phase 1. Adaptive and stepped axial scan modes are added in software to more precisely specify and shape the planes imaged during MROI volume imaging [0016] MROI imaging allows scientists to observe interacting cortical regions in the mammalian brain at multiple spatial scales: cellular resolution imaging within distinct and separated anatomical and functional regions. Examples include the transformation of visual input from lower to higher-order representations and associations[ ] in primary visual cortex (V 1 ) and the sensorimotor loop interactions[ ] between somatosensory (S 1 ) and motor (M 1 ) cortices ( FIG. 1 c ). Preferred Embodiments [0017] Accordingly, provided herein as one preferred embodiment is an apparatus for targeting a sample, the apparatus comprising: a source of beamed electromagnetic energy producing a beam; a compact scanner assembly for multi-region of interest (MROI) angular scanning of the beam; and optics for imaging the angular scanned beam from scanner assembly to a microscope objective lens, wherein the microscope objective lens converts the angular scanned beam to a focused spatial focusing scanned beam onto intact cellular tissue. [0018] In another preferred embodiment is an apparatus for imaging a sample, the apparatus comprising: a source of beamed electromagnetic energy producing a beam; a compact scanner assembly for multi-region of interest (MROI) angular scanning of the beam; and optics for imaging the angular scanned beam from scanner assembly to a microscope objective lens, wherein the microscope objective lens converts the angular scanned beam to a focused spatial focusing scanned beam onto intact cellular tissue; and a detector to detect the resulting radiation signal from the sample region. [0019] In another preferred embodiment is provided a compact scanner assembly for multi-region of interest (MROI) imaging of intact cellular tissue, comprising a set of three electromagnetically actuated scanning mirrors, the first scanning mirror comprising a resonant scanner (R) driven at its resonant frequency, the second scanning mirror comprising a galvanometer scanner (G 1 ) having a mirror (m 1 ), the third scanning mirror comprising a galvanometer scanner (G 2 ) having a mirror (m 2 ), wherein the galvanometer scanner (G 1 ) and the galvanometer scanner (G 2 ) are driven by a lower bandwidth control signal specifying an angle for mirror (m 1 ) and for mirror (m 2 ), wherein the scanners are arranged sequentially as the resonant scanner (R) followed by the galvanometer scanner (G 1 ) and the galvanometer scanner (G 2 ), wherein the set of three scanning mirrors are within a single scanner assembly (RGG). [0020] In another preferred embodiment is provided the compact scanner assembly, wherein the set of three scanning mirrors are oriented within the compact scanner assembly to produce a two-dimensional (X & Y) angular scan at an assembly output, wherein the resonant scanner (R) and the galvanometer scanner (G 1 ) are oriented to produce scanning in the same (X) angular direction. [0021] In another preferred embodiment is provided the compact scanner assembly, wherein the compact scanner assembly for MROI combines raster scanning with random-access scanning to target multiple geometric ROIs for imaging. [0022] In another preferred embodiment is provided the compact scanner assembly, wherein the geometric ROIs comprise a linear ROI, a planar ROI, or a three-dimensional ROI. [0023] In another preferred embodiment is provided the compact scanner assembly, wherein the geometric ROIs comprise a rectangular ROI, a line ROI, a curved line ROI, a circular ROI, an elliptical ROI, a multi-sided ROI, a polygon ROI, an irregular ROI, a cubic ROI, a prismatic ROI, a cylindrical ROI, or a spherical ROI. [0024] In another preferred embodiment is provided a method of imaging a sample, comprising: scanning a beam of electromagnetic energy over an intact tissue sample; using a compact scanner assembly for multi-region of interest (MROI) imaging of intact cellular tissue disposed to receive the beam; and detecting the resulting radiation signal from the sample region. [0025] In another preferred embodiment is provided a method for providing multi region cellular resolution imaging, comprising the steps: providing a device as herein, using the device to obtain MROI images. [0026] In another preferred embodiment is provided a method of targeting a sample of cellular tissue, comprising: directing a beam of electromagnetic energy at an intact tissue sample; and using a compact scanner assembly for multi-region of interest (MROI) targeting of intact cellular tissue disposed to receive the beam. [0027] In another preferred embodiment is provided a method for providing multi region cellular resolution targeting, comprising the steps: providing a device as herein, using the device to target cellular tissue. [0028] In another preferred embodiment is provided the method as herein, wherein the cellular tissue is a synapse. [0029] In another preferred embodiment is provided the method as herein, further comprising the step of ablating of the targeted cells. [0030] In another preferred embodiment is provided the method as herein, further comprising the step of optogenically stimulating the targeted cells. [0031] In another preferred embodiment is provided the method as herein, further comprising the step of photo-stimulating the targeted cells. [0032] In another preferred embodiment is provided the methods as herein, wherein the compact scanner assembly for MROI combines raster scanning with random-access scanning to target multiple geometric ROIs for targeting wherein the geometric ROIs comprise a linear ROI, a planar ROI, or a three-dimensional ROI. [0033] In another preferred embodiment is provided the method as herein, wherein the geometric ROIs comprise a rectangular ROI, a line ROI, a curved line ROI, a circular ROI, an elliptical ROI, a multi-sided ROI, a polygon ROI, an irregular ROI, a cubic ROI, a prismatic ROI, a cylindrical ROI, or a spherical ROI. BRIEF DESCRIPTION OF THE FIGURES [0034] FIG. 1 is a three part (a), (b), (c) graphic. FIG. 1 a show information flows between cortical columns. FIG. 1 b shows MROI imaging combines random access and raster scanning. FIG. 1 c shows example applications of MROI optical recordings. [0035] FIG. 2 is a bra graph. FIG. 2 shows growing needs for products in the marketplace that provide solutions offered by the present invention. [0036] FIG. 3 is a two part graphic, (a) and (b). FIG. 3 a shows RGG scanner combination for MROI imaging. FIG. 3 b shows scanner characterization by diameter and scan angle. [0037] FIG. 4 is an image. FIG. 4 shows volume imaging and MROI. [0038] FIG. 5 is a graphic illustration. FIG. 5 shows a compact scanner assembly for MROI imaging. [0039] FIG. 6 is a graphic illustration. FIG. 6 shows MROI volume imaging graphed against axial sweep. DETAILED DESCRIPTION OF THE INVENTION [0040] Referring now to FIG. 3 , Multi Region-Of-Interest (MROI) imaging is a resonant-galvo-galvo (RGG) scanning approach that extends widely used RG raster scanning and GG random-access scanning approaches ( FIG. 3 a ) for in vivo 2PLSM to allow two innovative new capabilities: random-access imaging, rather than point or contour random-access scanning 10-12 , to allow robustly motion correctable optical recordings across a wide FOV multi-region cellular resolution imaging with greater compatibility to existing microscopes and greater scalability, to beyond 2 regions, than existing approaches 6,13 RGG scanning may also be used in other key applications in brain science. [0041] Random-Access Imaging [0042] Previous random-access laser scanning approaches described to date have employed galvo or acousto-optic deflector 12,14-17 scanning pairs. Galvo scan bandwidths are limited to ˜1 kHz line rates. For this reason, random-access optical recordings with GG scanner pairs have employed complex scan trajectory based on parametric 10,18 or heuristic 11 optimization of scanner trajectory to maximize the recording rate and the number of sites recorded. However, such approaches are only suited for motion-free in vitro applications; locking such complex scans during in vivo imaging would require highly complex registration and control heuristics. [0043] Acousto-optic deflectors (AODs) allow extremely fast (inertia-free) scans suited for multi-area scanning, but are not currently suited for use with wide-FOV optics due to their limited scanner étendue 19 , defined as the product of the optical aperture and angular range ( FIG. 3 b ). Étendue is an invariant quantity preserved by any subsequent optics imaging the scanner to the objective back entrance aperture. Current wide FOV objectives (Nikon CFI 75 16×) have back entrance apertures ˜20 mm and entrance angular ranges of +/−4°. Filling the aperture (to achieve full resolution) and angular range (to reach full extent of the FOV) would require a scanner étendue of 160 mm-degrees; with even larger values required for emergent wider FOV objectives 6 . AODs suited for 2PLSM are currently limited to only <50 mm-degrees and thus cannot fully utilize even today's wide-FOV objectives 15 . [0044] Referring now to FIG. 1 , The Multi-ROI Imaging strategy overcomes these limitations by combining the 16 kHz line rate of resonant scanning (Cambridge Technology CRS 8) with 2D random-access GG scanning to allow random-access imaging ( FIG. 1 b ). Galvo scanners used for 2PLSM can reach large étendue values of 240 mm-degrees (e.g. the Cambridge Technology 6215 6 mm, +/−20° scanner). Moreover, their limited scan speed does not greatly limit MROI imaging: the GG transit time (100-500 μs) is negligible, to first order, between each rectangular ROI in comparison to each ROI imaging period. The photon efficiency of targeting the laser scan only to ROIs can be flexibly allocated to achieve gains in imaging speed, pixel integration time, and/or image resolution, compared to the reference full FOV raster scan (Table 1). [0000] TABLE 1 Table 1: Example Multi-ROI Imaging scenarios Frame ROI # Rate (Pixel Time Zoom Pixelation ROIs (Hz) (normalized) Comments 1 256 × 256 1 60 1 Reference RG raster of full FOV 4 64 × 64 2 120 4 Max gain in frame speed 4 64 × 64 3 80 4 4 64 × 64 4 60 4 Pure gain in ROI signal quality 4 128 × 128 2 60 2 Gain in ROI line resolution [0045] Multi-Region Imaging [0046] Two very recent reports have described new technologies to address the challenge identified by this proposal: simultaneous cellular-resolution imaging of multiple separated cortical regions. [0047] One technology circumvents the limited FOV of standard microscope systems by using two independent microendoscopic paths 13 . Another technology, Trepan2P, employs two parallel GG scanner pathways, together with temporal multiplexing, to achieve targeted two-area imaging 6 . [0048] Compared to MROI imaging, both of these techniques are considerably more complex to implement and align; moreover, neither readily scales to beyond two regions. Moreover Trepan2P is not readily extensible to 10× faster resonant (RG) raster imaging, so that its frame rates are slower than MROI imaging (Table 1) despite truly simultaneous dual region imaging. [0049] MROI imaging hardware is, in contrast, readily inserted as a plug-and-play upgrade to existing 2PLSM systems, reaching at least >1 mm diameters as provided here (Aspect 1). [0050] Other RGG Scanning Applications [0051] Notably, the same core RGG-scanning technology, combining random and raster-access scanning, can be applied to other key applications in brain science. For instance, MROI imaging achieves fast, photon-efficient imaging for subcellular scale applications, such as comprehensive mapping of synaptic input to a single neuron. RGG scanning may also be applied to multi-site photostimulation applications using optogenetics 20 , which has been recently made compatible with two-photon excitation using area scanning approaches targeted to neural cell bodies 21,22 . Finally, RGG scanning is applicable to neural imaging and photostimulation applications in other brain areas [ ] and other model organisms such as the fly [ ] and zebrafish [ ] that are accessible by 2PLSM. These uses broaden the impact of this research. [0052] Approach [0053] Preliminary Data [0054] Referring now to FIG. 4 , Vidrio Technologies flagship ScanImage product has been widely used for single cortical region (column) in vivo imaging applications in the mammalian brain [ . . . ], including recent applications using resonant scanned volume imaging [ . . . ] ( FIG. 4 a ). One of Vidrio Technologies' customers (HHMI/Janelia Research Campus) has constructed a custom optical system that includes a resonant scanner and galvo scanner pair in sequence. Vidrio has developed alpha-level software for this customer demonstrating the concept of MROI imaging ( FIG. 4 b ). Recently this was combined with swept axial scanning to allow mapping of activity along multiple adjacent dendritic segments ( FIG. 4 c ). [0055] Aspect 1: MROI Scanner Assembly Prototype [0056] Referring now to FIG. 5 , a compact scanner assembly is designed and fabricated to mount and align the scanner surfaces (mirrors) of one resonant and two galvo scanners ( FIG. 5 ). [0057] We have identified the following key design criteria for this: [0058] Scanner étendue (aperture-angle product) of >100 mm-degrees a. Scan at or near diffraction limit across 1 mm diameter with current objectives [0060] Avoid relay optic couplings to minimize assembly size a. Integrate readily into existing microscope systems [0062] Minimize inter-scanner distances a. Minimize pupil shift effect limiting power throughput at large angles [0064] Soundproofed housing (to below 40 dB) a. Avoid sound distractors of animal behavior and learning experiments [0066] Design and Manufacture [0067] The Nikon CFI 75 16× is a representative recent wide-FOV objective with full entrance aperture and angular range values of 18 mm and 9 degrees, respectively (162 mm-degrees of étendue). Full aperture & angle imaging through this objective achieves diffraction-limited imaging across a reported field of 1.8 mm diameter, but requires the use of additional custom relay optics 6 (see Risks & Alternatives). We provide the use of a more compact assembly to achieve ease of integration with existing microscope systems, while still achieving >1 mm FOV. [0068] Referring again to FIG. 5 , a scanner assembly of 5 mm aperture size and 20 degree angular range (100 mm-degrees) is built from standard components (CRS 8 resonant and 6215H/6 mm galvo scanners; Cambridge Technology). These are selected and ordered such that each successive mirror is larger than the previous mirror: Resonant X (5 mm), Galvo X (6 mm), Galvo Y (6 mm elongated). This, along with maximal close packing, will ensure the full angular range of each scanner is incident on each successive scanner ( FIG. 5 ). [0069] Close packing of the scanner furthermore minimizes “pupil shift” caused by the axial displacement between the scanner surfaces. In 2PLSM systems, scanners are imaged to the objective entrance by telescope optics of magnification M, in order to maximize filling of the objective and thereby the resulting optical resolution 25 . Axial displacement is also imaged to the objective entrance, causing beam to be shifted on the entrance pupil (i.e. pupil shift) at large scan angles, reducing power throughput. The axial displacement at objective is more strongly magnified by M 2 (e.g. M=4× to magnify 5 mm scanner to 20 mm objective aperture results in 16× axial displacement magnification). Thus minimizing scanner separation is important. [0070] Despite the pupil-shift effect, virtually all existing 2PLSM systems already use closely spaced RG or GG scanner pairs. Our provided three scanner design adds minimal amount since the thin-shafted resonant scanner is placed very closely to the subsequent X galvo ( FIG. 5 ). Additionally, this configuration allows resonant scanner to extend vertically away from the optical axis. Consequently, the lateral footprint of assembly remains nearly unchanged from a standard GG scanner pair, allowing for ease of integration into existing 2PLSM optical trains. [0071] An initial design of the RGG scanner block is developed using mechanical engineering skills on staff. This design refines the design, adds a soundproofed enclosure, and adds cable connector blocks. [0072] Evaluation [0073] The prototype assemblies are tested using a collimated laser diode (CPS180; Thorlabs), expanded to a 5 mm beam, at the entrance, and a simple photodiode at the output. The GG pair is positioned to central, intermediate, and full deflection angles across the +/−10° range in each dimension. At each 2D angular coordinate, the output beam diameter and relative power is measured, to ensure that a 5 mm diameter and >50% transmission (relative to central angle) is achieved throughout the 20° angular range. [0074] Risks & Alternatives [0075] The current design adds pupil shift beyond current 2PLSM scopes which may lead to significant power dropoff towards edges of the FOV, possibly falling to <50% transmission relative to central angle. A more optimal optical design for the RGG scanner assembly eliminates pupil shift via afocal relay optics between scanners 26 . Such optics are further optimized, together with the microscope scan optics, to avoid off-axis optical aberrations that otherwise prevent the full utilization of étendue beyond 100 mm-degrees. Optimizing to support >150 mm-degrees maximizes the FOV utilization of both existing (e.g. Nikon CFI 75 16×) and emerging wide-FOV objectives 6 . This design is not a compact upgrade path for existing 2PLSM systems, but is used for new MROI 2PLSM systems. [0076] Aspect 2: MROI Imaging System Prototype [0077] Referring now to FIG. 4 , a software prototype is developed for MROI volume imaging using arbitrary RGG scanning hardware (including compact configurations such as in Aspect 1). This software is built on the backbone of Vidrio's ScanImage production hardware and software for resonant raster scanning 2PLSM ( FIG. 4 a ). Using this software prototype, MROI optical recordings in two or more separated cortical volumes may be shown in customer laboratories. [0078] Lateral MROI Imaging [0079] Software will generate & acquire small raster scans at each ROI and then reposition the GG pair to each subsequent ROI with command for shortest transit time possible, computed from a two-parameter model sufficient to describe galvo control systems: acceleration and max velocity 10 . [0080] The backbone ScanImage platform uses field-programmable gate array (FPGA) hardware to process high-speed input light data at each resonant scanner period into image lines. For MROI optical recordings, the imaging and non-imaging (inter-ROI transit) times will be discretized into integer sets of the 8 kHz resonant scanner periods, with transit periods being discarded at the FPGA level. [0081] Because the pupil-shift effect and other factors limits power transmission as a function of scan angle, power normalization is implemented whereby power is increased towards the edges of the FOV. This normalization is superimposed atop power normalization for each resonant scanned ROI, to compensate for the variable dwell time at each pixel. [0082] Volume MROI Imaging [0083] Referring now to FIG. 6 , users are provided the ability to select ROIs in two-dimensions from a reference image or image stack recently collected via resonant or galvo raster scanning (latter having a larger angular range). For three-dimensional volume imaging, an axial sweep scan command signal is generated for analog control of focus, e.g. using either a piezoelectric actuator or an electrically tuned lens (Optotune). The axial sweep is synchronized to a user-specified integer number Z of axial planes over a specified range, each containing a set of 2 or more selected ROIs, with an ordering & image directionality to optimize overall galvo transit time ( FIG. 6 ). Volume imaging rates are F/(Z+1), where F is the 2D MROI frame rate, with one frame period discarded to allow for the axial scanner flyback. For instance, imaging of 3 ROIs of 4× zoom through 8 axial planes is achieved at ˜8 Hz with 64×64 pixel imaging (Table 1). [0084] Evaluation [0085] An MROI imaging prototype system is tested. MROI volume imaging of neural ensemble activity in 2 or more distinct cortical columns is shown at >4 Hz and >100 neurons per ensemble. For 1 mm diameter FOV (Aspect 1), specifying ROI zoom factors of 4×(250 μm diameter) and a set of 8 planes (e.g. 30 μm spacing) would be expected to contain >100 cells in even sparsely labeled subjects, with expected rates of ˜8 Hz and ˜4 Hz for 3 and 4 ROIs, respectively. [0086] For each MROI volume imaging dataset, a comparison acquisition is obtained using conventional raster volume imaging. The MROI advantage is determined by computing the neuronal volume imaging figure-of-merit M: [0000] M=T vol ×Σ i N ROI SNR i [0000] where T vol is the imaging period for the full volume, SNR i is the signal-to-noise ratio assessed at each ROI, and N ROI is the number of ROIs selected for MRoI imaging. For an ROI zoom factor of 4×, SNR increases of up to 4× per ROI and aggregate frame speed increases up to 2× would nominally achieve M=16 regardless of scenario chosen (Table 1), with real values of M>5 after accounting for inter-ROI transit times and possible sublinear scaling of SNR with pixel integration time. [0087] Risks and Alternatives [0088] A stepped axial scanning mode was considered using a fast stepping electrically tuned lens 27 . This would avoid the tilting of the image volume that occurs with the swept axial scan provided. 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Two-photon optogenetics of dendritic spines and neural circuits. Nat Methods. 2012; 9(12):1202-1205. doi:10.1038/nmeth.2249. [0112] 23. Rickgauer J P, Tank D W. Two-photon excitation of channelrhodopsin-2 at saturation. Proc Natl Acad Sci USA. 2009; 106(35):15025-15030. doi:10.1073/pnas.0907084106. [0113] 24. Williams S C P, Deisseroth K. Optogenetics. Proc Natl Acad Sci USA. 2013; 110(41):16287. doi:10.1073/pnas.1317033110. [0114] 25. Zipfel W R, Williams R M, Webb W W. Nonlinear magic: multiphoton microscopy in the biosciences. Nat Biotechnol. 2003; 21(11):1369-1377. doi:10.1038/nbt899. [0115] 26. Tsai P S, Kleinfeld D. In vivo two-photon laser scanning microscopy with concurrent plasma-mediated ablation. In: Frostig R, ed. Methods for In Vivo Optical Imaging. CRC Press; 2009: 59-115. [0116] 27. Sheffield M E J, Dombeck D A. Calcium transient prevalence across the dendritic arbour predicts place field properties. Nature. 2014. doi:10.1038/nature13871. [0117] 28. Patterson G H, Piston D W. Photobleaching in two-photon excitation microscopy. Biophys J. 2000; 78(4):2159-2162. doi:10.1016/S0006-3495(00)76762-2. [0118] The references recited herein are incorporated herein in their entirety, particularly as they relate to teaching the level of ordinary skill in this art and for any disclosure necessary for the commoner understanding of the subject matter of the claimed invention. It will be clear to a person of ordinary skill in the art that the above embodiments may be altered or that insubstantial changes may be made without departing from the scope of the invention. Accordingly, the scope of the invention is determined by the scope of the following claims and their equitable Equivalents. [0119] Notes [0120] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls. [0121] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. [0122] Method examples described herein can be machine-implemented or computer implemented at least in part. Some examples can include a tangible computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, the code may be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times. These computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like. [0123] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

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BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lift mechanism for use with various agricultural and other implements requiring height adjustment. 2. Description of the Prior Art In the prior art various lift cylinder mechanisms have been advanced for raising large implements, particularly tool bar frame implements such as field cultivators and chisel plows. For example, U.S. Pat. No. 4,194,573 shows an agricultural subsoil implement having individual wheel assemblies which are controlled by hydraulic cylinders for raising and lowering the support wheels relative to the frame and thus raising and lowering the frame relative to the ground. The cylinders are directly supported back to the frame, and this requires substantial complexity in the design in order to maintain the correct placement of the cylinder mount location. Further, adjustments for adjusting the cylinder position to compensate for wear is quite difficult. This is particularly true where a stop member is provided on the cylinder so that when the cylinder is retracted it returns to a fixed length. U.S. Pat. No. 4,117,893 shows an agricultural tool bar with individual wheel assemblies that are adjusted through the extension and retraction of hydraulic cylinders for depth control. The cylinders are also mounted directly between the frame and the wheel assemblies and have the same problems as those shown in U.S. Pat. No. 4,194,573. U.S. Pat. No. 4,106,568 shows a chisel plow with a rock shaft depth control of the conventional type. The device of the present invention is designed specifically to correct the torsion loading present in the axle tubes shown in U.S. Pat. No. 4,106,568. Threaded adjustments are known for adjusting depth controls. For example, in U.S. Pat. No. 2,655,851 there is a lift cylinder supported on an overhead frame and which acts directly to pivot a support member for the wheels and has a threaded piston rod for adjustment purposes. U.S. Pat. No. 4,117,893 also shows a cylinder mounted on an overhead frame and operable for raising and lowering support wheels. Threaded stops are also known. For example, U.S. Pat. No. 3,700,043 shows a threaded stop for stopping movement of the piston rod in a desired location. Typical additional patents which illustrate the state of the art and which were uncovered in the course of a preliminary search include U.S. Pat. Nos. 1,844,124; 3,090,446; 3,648,780; 3,172,218; and 4,077,477. SUMMARY OF THE INVENTION The present invention relates to a lift mechanism using a double acting hydraulic cylinder in the lift mechanism which acts directly on a pivoting axle leg that supports the wheels of an implement. The axle leg is fixed to a pivoting axle tube which is pivotally supported on the implement frame. The cylinder is connected to a mast that is rotatably or pivotally mounted on the axle tube. An adjustable reaction link is used for reacting load from the mast (as it tends to rotate) back to the implement frame. All supporting components are stressed in either tension or compression (except for small torsion loads caused by frictional forces in the rotational mountings of the axle tube) thereby simplifying the construction of the lift framework itself and additionally permitting reduction in the size and weight of the axle tube. The forces are resolved into the tension and compression components by use of the described three bar linkage, which eliminates substantial torsion loading in any parts caused by the load on the wheels supporting the implement. A simple length adjustment link is used to permit compensation for wear giving a strong, economical and very reliable lift mechanism. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a fragmentary side elevational view of a typical tool bar implement frame having support wheels operated by an integral lift cylinder mechanism made according to the present invention; and FIG. 2 is a top plan view of the device of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT An implement frame indicated generally at 10 is shown only schematically in the present drawings, because it can be any desired type of frame such as those discussed in connection with the prior art identified above, or tool bar frames used for field cultivators and chisel plows and air seeders made by Wil-Rich, Inc., of Wahpeton, N. Dak., the assignee of the present application. The frame 10 includes fore and aft extending frame members 12, 12 which are spaced transversely apart and fixed in place with transverse frame members 13. Suitable cross braces 14 can be used on the frame 10, if desired. Cross members 15 are used adjacent the wheel mounting regions for additional strength. The lateral or transverse frame members 13 are used for mounting suitable earth working tools or other devices (not shown) such as field cultivator shank assemblies or chisel plow shank assemblies. The height of the frame 10 relative to the ground level is controllable with the device of the present invention by controlling the relative positions of a plurality of walking beam assemblies 20, one of which is shown in the drawings. The walking beam assembly 20 carries spindles 22, 22 on which the wheels 21, 21 are mounted. The walking beam assembly 20 in turn is pivotally mounted on a support shaft 23 that is mounted at the end of an axle leg 24. The upper end of the axle leg 24 is welded to an axle tube 25. The axle tube 25 in turn is rotatably mounted in a pair of bearing supports 26, 26 which in turn are supported on axle tube supports 27, 27. Each of the axle tubes supports 27 is supported from a separate one of the force and aft frame members 12, and the axle tube 25 is prevented from sliding axially relative to the bearing supports 26 by suitable stop members 28 which are welded to the tube but yet will permit the tube to rotate during adjustment of the axle leg. The vertical position of the wheels 21, 21 relative to the frame is adjusted by controlling the pivoting of the axle tube. In many previous devices, the adjustment of height of the frame relative to the wheels has been accomplished by having the axle tube 25 act as a torsion shaft which is operated by a cylinder that is offset from the center line of the axle leg 24. In previous lift arrangements substantial torsion loads were introduced into the axle tube, requiring heavier tubes with greater wall thicknesses and larger diameters than needed with the present lift. The device of the present invention eliminates torsion loads in the axle tube by providing a three bar linkage illustrated generally at 30 to support the loads on the axle leg from the wheels 21 and react the loads back to the frame. The three bar linkage includes a mast assembly 31 that comprises a pair of spaced members 32 which are rotatably mounted on the axle tube 25 through the use of a pair of mast bearing caps 33, one of which is suitably attached to each of the members 32. Mast assembly 31 further includes a cylinder support ear 34 that is mounted between the members 32, 32 at the upper ends thereof. Ear 34 is provided with an aperture that receives a mounting pin 35 for pivotally mounting the base end of a double acting hydraulic cylinder assembly 37 to support ear 34. The cylinder assembly 37 is operated through a suitable valve 38 to extend and retract a cylinder rod 41. Rod 41 has a clevis or rod end 42 pivotally mounted by a pin 43 to an ear 44 that is fixed to the axle leg 24. An adjustable mechanical stop member 45 is mounted on the cylinder rod 41 so that the retracted position of the rod can be mechanically determined. The stop 45 will engage the end of the cylinder to provide a precise mechanical location for the lowest position of the frame. The stop 45 is adjustable to permit a fixed position to be achieved when retracting the cylinder assembly 37. The force or load from the weight supported by wheels 21 that is reacted by the lift cylinder assembly 37 to the mast assembly is transmitted back to the frame 10 through a force link 50. The mast, as previously explained, is free to rotate on the tube 25. The force link 50 comprises a tube that is pivotally mounted at one end as at 51 between the mast members 32, 32 of the mast assembly. A threaded adjustment rod 52 is threaded through a nut 53 which is welded to the end of the tube. The rod 52 can be threaded to change the length of the force link as desired. The lower end of the force link, comprising the threaded rod 52, is mounted through an anchor assembly indicated generally at 55 that includes a cross member 56 that has an opening through which the threaded rod 52 is passed. Lock nuts 57 are used for clamping the lower end of the rod 52 and thus the lower end of the force link securely to the anchor assembly. In addition to the cross member 56, the anchor assembly has fore and aft extending members 58 that are attached to lateral frame members 13 and 15 with U bolts, as shown in FIG. 1, so that the force link is securely anchored back to the implement frame. As mentioned, the force exerted on the axle leg 24 by the lift cylinder 37 is carried back to the mast assembly 31 which is free to rotate on the axle tube 25, and the load is reacted through the force link 50 back to the frame. This puts the cylinder assembly 37 in compression and the force link 50 in compression while the mast assembly carries some tension. The axle tube 25 is not subjected to torsion loads during the raising and lowering operations. Additionally, the length of force link 50 can be adjusted to compensate for wear and the stop 45 can be utilized for letting the lift cylinder return to a set position when it is retracted to lower the frame relative to the ground. Thus, a simple framework is utilized by having a mast that pivots relative to the movable or pivoting axle support, which is directly centered on the axle leg. The linkage mechanism carrying the implement load forces are subjected to tension and compression load rather than torsion loads.

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