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TECHNICAL FIELD OF THE INVENTION [0001] This invention generally relates to stents for implantation into blood vessels or other organs, and more specifically to stents that are absorbable over time and capable of local drag/gene delivery for enhancing therapeutic effects. BACKGROUND OF THE INVENTION [0002] Intraluminal stents are commonly employed for treatment of various vascular conditions such as arteriosclerosis, often as coronary artery implants. A stent can be implanted at the site of a vessel stricture or steno sis using a conventional balloon catheter delivery system as used in angioplasty. Stents also maybe employed in body passageways other than blood vessels to treat strictures or prevent luminal occlusion. Such stents ordinarily consist of a cylindrical network of very small metal wires. The stent is inserted in a small-diameter configuration and then expanded to a large-diameter final configuration against the walls of the blood vessel or other body lumen. Such stent structures and implantation techniques are well known. [0003] Great efforts have been expended to modify metallic stents to eliminate stress-induced and/or inflammation-induced restenosis, and to effectively deliver therapeutic agents to lesion sites. Some advancements in drug-coated metal stents have been made recently. However, metallic stents still present a potential vessel injury problem. Furthermore, the delivery of medicine to a lesion site either by local or systemic means is unsatisfactory with current stent and catheter technology. The present invention addresses these problems. SUMMARY OF THE INVENTION [0004] In accordance with a principal object of the present invention, luminal support and localized treatment of lesion sites within body passageways is accomplished by the implantation of an expandable biodegradable polymeric stent that includes therapeutic agents. By virtue of its gradual absorption over time, the inventive stent avoids residual stress, and permits local drug delivery or local radiation treatment. [0005] In its preferred implantation, the stent of the present invention provides adequate mechanical support during and following the interventional procedure, and, by being absorbed over controllable periods, avoids chronic mechanical disturbance of the vessel wall. The residual stress against the vessel wall is eliminated after the stent is degraded. During the degradation process, loaded therapeutic agents are released in a controlled fashion, and effective concentrations at target lesions can be maintained. Local radiation treatment can likewise be maintained. [0006] The stent of the present invention preferably has the following features: (1) it has an all-polymer construction with similar mechanical function to conventional metallic stents; (2) it is constructed with fiber cords having both central and peripheral lobes and is stabilized by longitudinal rods, thus presenting a low profile during delivery and a large effective diameter following expansion; (3) it is expandable with an expansion ratio that can be customized to meet various needs; (4) it can be deployed at body temperature with low inflation pressure (3 atm); (5) it is a temporary implant; (6) it may be a local drug or gene delivery device; (7) it may be a local radiation therapy device; and (8) it can include fibers with various functions (mechanical support, acute drug burst, long-term drug release, etc.), enabling a variety of treatment options including multiple functions with a single stent and using a single stent-implant procedure. [0007] The present invention has a number of advantages over conventional stents. Firstly, in contrast to metal stents, the polymeric stent of the present invention is a temporary implant. The temporary residence permits the residual stress against the vessel wall to be resolved, a factor commonly leading to in-stent restenosis in the case of metallic stents. Secondly, the inventive stent is also capable of carrying therapeutic agents either incorporated in the polymer bulk or coated on the polymer surface. Thirdly, it is possible to control the operation of the inventive stent by selection of the polymer composition, the polymer molecular weight, fiber cord diameter and processing conditions, thus controlling the degradation rate, drug release rate and period of mechanical support. Fourthly, compared with tubular-shaped polymeric stents, the inventive stent has superior expandability and flexibility. Additionally, the inventive stent also has advantages over the “zigzag” polymeric stent recently disclosed in the prior art (Circulation, vol. 102, pp. 399-404, 2000), since it is deployed at body temperature with low inflation pressure. [0008] In addition to being biodegradable, the stent of the present invention synergistically combines excellent mechanical support and local drug delivery, for both short-term and long-term applications. Current metallic stents are incapable of delivering drugs without polymer coatings. Moreover, metallic stents are known to be a stimulus for chronic vessel injury. Other current approaches, such as the combination of a metallic stent and bolus drug delivery by a porous angioplasty balloon, provide both mechanical support and short-term drug delivery. However, other than initial control of drug concentration at the lesion site, the porous angioplasty balloon approach is limited in its application and is incapable of performing certain desirable functions, such as prolonged drug delivery and transient radiation therapy. The biodegradable polymeric stent of the present invention provides sufficient mechanical strength as well as controllable short-term and long-term drug delivery while eliminating the stimulus for chronic vessel wall injury. BRIEF DESCRIPTION OF THE DRAWINGS [0009] For a more complete understanding of the present invention and the advantages thereof reference is now made to the following description taken in conjunction with the accompanying Drawings in which: [0010] [0010]FIG. 1 is a schematic illustration of the three-dimensional structure of an expandable stent according to the present invention; [0011] [0011]FIGS. 2A, 2B and 2 C are schematic end views of the inventive stent at three stages during deployment with an inflatable balloon shown therein in phantom, FIG. 2A showing the stent in its furled state, FIG. 2B showing the stent in a partially expanded state, and FIG. 2C showing the stent in its fully expanded state; [0012] [0012]FIG. 2D is a schematic perspective view of the inventive stent in its fully expanded state; and [0013] [0013]FIGS. 3A and 3B are schematic end views of an alternative embodiment of the inventive stent. DETAILED DESCRIPTION OF THE INVENTION [0014] Referring to FIG. 1, a preferred embodiment of a stent according to the present invention is shown and generally designated by reference numeral 10 . The stent 10 comprises a coiled cord 50 of non-metallic material, preferably a polymer fiber or ply of multiple polymer fibers, wherein the polymer preferably comprises Poly-L-Lactic Acid (“PLLA”). The use of PLLA to construct the stent 10 is advantageous because it is biodegradable. It degrades away gradually within the body, the chemical products of the degradation process being primarily carbon dioxide and water, which are harmless to the host patient. Degradation occurs over a period of about six months to three years, mainly depending on the molecular weight of the polymer employed. PLLA is also advantageous because it can be impregnated with drugs or other chemical agents for local treatment of tissue at the stent implant site. [0015] Byway of example, the stent 10 of FIG. 1 is constructed with twelve coil rotations of a single-fiber cord, each rotation having one central lobe 20 and three peripheral lobes 30 . The twelve central lobes 20 form the backbone of the stent 10 . Three longitudinal rods 40 are attached on the exterior surface of the central lobes 20 , preferably using a viscous PLLA-chloroform solution. The rods 40 may comprise the same single-fiber material as the coil of lobes 20 and 30 . Alternatively, the coil of lobes 20 and 30 and the rods 40 may comprise a multiple-fiber ply material. For example, the coil of lobes 20 and 30 may be formed from a double-fiber ply material, and each of the three rods 40 may be formed from a triple-fiber ply material for added rigidity. Also, by way of example, the length of inventive stent is 15 mm and the initial diameter is 1.9 mm. In this example, the final diameter, after balloon expansion, can reach 3.24 mm. The length of the stent can be increased by increasing the number of coil rotations. The peripheral and central lobe diameters determine the final diameter of the stent. To assure mechanical integrity, it is preferred that the coiled lobes 20 and 30 of the stent 10 be formed from a single cord that is continuous end-to-end. [0016] The mechanical strength of the stent 10 can easily be varied (1) by adjusting the coil density; or (2) by adjusting the fiber ply. In practice, a stent with 15 coil rotations and a length of 15 mm will be stronger than a stent of the same length with 12 rotations. However, a stent in which the cord 50 is composed of a multiple-fiber ply will have higher resistance to radial compression. A double-fiber ply will have about twice the radial compression resistance of a single-fiber construction, and triple-fiber ply will have about three times the radial compression resistance of a single-fiber construction. Additionally, the diameter of the stent 10 can be adjusted (1) by adjusting the diameter of central and peripheral lobes; or (2) by adjusting the number of multiple peripheral lobes per central lobe. The stent diameter increases as the diameter of central and peripheral lobes increases, and vise versa. It will also be appreciated that more peripheral lobes with the same diameter results in a stent of larger diameter in its fully expanded state. [0017] The above-described design provides an excellent way to maximize the expandability of a polymeric stent. The major difference between metal and polymeric stent materials is that metal is more malleable and generally has a greater tensile strength. Thus, a metal wire can be deformed without affecting mechanical strength. In contrast, a polymer fiber cord cannot retain its original mechanical strength following permanent deformation (bending, for example). Despite the lower mechanical strength of polymeric materials relative to metals, the polymeric stent of the present invention has sufficient strength to retain its shape in the expanded state, thereby stabilizing the vessel or duct wall for the intended purposes as with a conventional metal stent. [0018] In accordance with an important concept of the invention, an extra length of cord is provided by the peripheral lobes to facilitate expansion from the furled state to the final large-diameter state. If the desired final length of the stent in the furled, multiple-lobe configuration is known, stents can be prepared using the exact same initial length of cord. After expansion, the final deployed length is achieved without damaging cord. It will be appreciated that this approach to stent design and fabrication provides a polymeric stent with excellent mechanical strength and flexibility for effective implantation. [0019] According to another important feature of the invention, the longitudinal rods 40 provide support for the flexible coiled cord 50 . Furthermore, the longitudinal rods 40 maintain the axial length of the stent 10 constant as its radial dimension increases during expansion. Solid wall tubular stents have the practical limitations that they are relatively inflexible, making it difficult for them to pass through sometimes tortuous vessel networks. This is because their relatively rigid cylindrical structure reduces the freedom to bend in all directions. In this invention, the integrity of the stent 10 is maintained by the longitudinal rods 40 , three in embodiment of FIG. 1 preferably arranged at 120° intervals. Therefore, the expandable stent 10 has the inherent flexibility of a coil design yet has sufficient rigidity for effective handling due to the presence of the longitudinal rods 40 . The advantages of this design compared with currently available clinical metal models will be readily apparent to the skilled practitioner. [0020] It should be mentioned that the number of longitudinal reinforcing rods can be selected based on the number of peripheral lobes that design considerations dictate. Preferably, the longitudinally aligned groups of peripheral lobes are equal in number to the longitudinal reinforcing rods, which are alternately positioned so that each rod is midway between its two neighboring peripheral lobe groups. In FIG. 1, the preferred arrangement is illustrated in which there are three longitudinal reinforcing rods 40 and three longitudinally aligned groups of peripheral lobes 30 . [0021] Prototypes of the inventive stent have been constructed using a fixture and manually winding a fiber cord in a spiral fashion along the fixture. The fixture employed included a central cylindrical mandrel attached to a base at one end, and three cylindrical side posts attached to the base and extending along and parallel to the mandrel, the posts being circumferentially spaced around the mandrel at 120° intervals. The stent is constructed by attaching one end of the cord to the free end of the mandrel, then winding the cord around the mandrel, and successively looping the cord around the posts moving downward toward the base until twelve rotations of the mandrel have been completed. Periodically during the winding process, each of three longitudinal rods 40 are attached to the central lobes 20 in the manner depicted in FIG. 1. Upon completion, the stent is slidably removed from the mandrel and side posts. Design of an automated system is contemplated for reducing the labor-intensive winding process used to make the prototype stents. [0022] The stent delivery and deployment system is based on conventional balloon catheter delivery systems used currently in clinical angioplasty. Therefore, the stent of the present invention can be implanted in practice using much of the conventional clinical deployment techniques used with metal stents. [0023] FIGS. 2 A-D illustrate the procedure of stent expansion and the structure of an expanded stent. In FIG. 2A, the stent 10 is in its small-diameter furled state, which enables the stent 10 to readily travel through a vessel to a site where it is to be deployed. A balloon 60 , shown in phantom, is provided inside the stent 10 to effect expansion. In this end view, the symmetrical spacing of the three rods 40 with the three longitudinally aligned groups of peripheral lobes 30 can be envisioned more clearly when considered together with FIG. 1. In the small-diameter furled state, it will be seen that the central lobes 20 viewed from the end of the stent 10 are generally triangular in shape. Thus, the term “small-diameter” is used herein to describe the relative size of the stent 10 in the original furled state, the “diameter” this context being the effective diameter of a circle or imaginary cylinder tangentially contacting the outer ends of the peripheral lobes 30 . [0024] In FIG. 2B, the stent 10 is starting to expand under the force of the expanding balloon 60 , as indicated by the arrows. For comparison, dashed lines are provided in FIG. 2B to show the configuration of the stent 10 in its original furled state as depicted in FIG. 2A. [0025] In FIG. 2C, the stent 10 is shown in its large-diameter, fully expanded state, in which the peripheral lobes 30 (shown in FIGS. 2A and 2B) have disappeared, their cord lengths having merged into the central lobe 20 of each of the twelve coils. Experimental data reveals that the stent 10 expands uniformly under increasing balloon pressure until it reaches its final diameter. The terms “final diameter” and “large-diameter” are used to describe the relative size of the stent 10 in its fully expanded state as depicted in FIG. 2C, the “diameter” being the effective diameter of a circle or imaginary cylinder tangentially contacting the outer edges of the longitudinal rods 40 . FIG. 2C is not drawn to an accurate relative scale compared to FIG. 2A. In practice, it has been found that sufficient cord length can be provided in the peripheral lobes 30 to cause the effective diameter of the stent 10 to approximately double in size going from the original furled state of FIG. 2A to the final fully expanded state of FIG. 2C. [0026] [0026]FIG. 2D shows the stent 10 with the balloon removed in its large-diameter state and also depicts the longitudinal rods 40 in their 120° spaced peripheral positions along the length of the stent 10 . The helical nature of the stent 10 in its fully expanded state is evident in FIG. 2D. Though the central lobes 20 are derived from a single cord of polymeric material that generally defines a helix in the fully expanded state, each lobe 20 can be viewed as one 360° length of cord with a leading end and a trailing end spaced apart by one-twelfth (in the case of a twelve-lobe stent) of the length of the stent 10 . For example, to illustrate this concept, the first lobe 20 a at the right end of the stent 10 of FIG. 2D has a leading end 70 and a trailing end 80 . The trailing end 80 of the first lobe 20 a corresponds to the leading end of the second lobe 20 b. The pattern continues through the length of the stent 10 , each lobe's trailing end corresponding to the next successive lobe's leading end until the last lobe is reached, whose trailing end (not shown in FIG. 2D) is the free end of the cord 50 at the left end of the stent 10 . [0027] It will be appreciated from FIGS. 1 and 2A that the stent 10 in its original furled state has a more complex shape. From the example shown in FIG. 2A, it will be appreciated that each central lobe 20 has three peripheral lobes 30 , a leading one of which being defined by a portion of the cord 50 that adjoins the leading end of the corresponding central lobe 20 , a trailing one of which being defined by a portion of the cord 50 that adjoins the trailing end of the corresponding central lobe 20 , and the last of the three peripheral lobes 30 being defined by a portion of the cord 50 at an intermediate point of the corresponding central lobe 20 . [0028] The stent 10 of the present invention can be adapted to a broad range of inflation pressures from 3 to 10 atm (a maximum pressure possibly even exceeding 10 atm). Experimental data has shown that, using a double-fiber ply stent, full expansion occurs at about 3 atm, and that the fully expanded diameter is stably maintained at inflation pressures of up to 10 atm. In the above-described example, the stent 10 has limited recoil about 4% when in an unstressed condition. The collapsing pressure holds at least up to 16 psi (i.e., greater than 1 atm), which is comparable to conventional metal stents. [0029] It will be appreciated that the preferred PLLA fibers preferably used for the stent fabrication can be loaded with a non-steroid type anti-inflammation agent, such as curcumin. The curcumin-loaded fibers significantly reduce inflammation at the stent implant site by reducing the adhesion of inflammatory cells. Other drugs can be used with the expandable biodegradable polymer stent of the present invention. The impregnated drugs can be prepared in a way that controllably delivers the drug over a predetermined time period. [0030] [0030]FIGS. 3A and 3B show an alternate embodiment of the inventive stent, generally designated by reference numeral 100 . The stent 100 has a furled state shown in FIG. 3A in which the fiber coils are tightly furled and central lobes 120 (one shown) are confined to a small diameter. There are three peripheral lobes per coil, which are designated by numerals 130 and, in this embodiment, are located inside the central lobes 120 . As in the previously-described embodiment of the stent 10 shown in FIG. 1, there may be twelve coils, which are formed from a continuous cord and extend longitudinally to define the body of the stent 100 . Each coil has a large central lobe 120 and three internally-disposed peripheral lobes 130 , shown in FIG. 3A. As in the previously described stent 10 , the stent 100 has longitudinally extending rods 140 that support the coil structure. When the stent 100 is expanded as shown in FIG. 3B, the peripheral lobes merge into a single large-diameter central lobe 120 for each of the twelve coils of the stent 100 . Using this construction of internal peripheral lobes 130 , the ratio of the final expanded stent diameter to the initial furled stent diameter can be greater than a factor of two. [0031] Those skilled in the art will appreciate that the inventive stent, in its disclosed embodiments or variations thereof, provides mechanical and therapeutic advantages over conventional stents. In addition, advantageous treatments will suggest themselves to the skilled practitioner considering the foregoing description of the invention. By virtue of the biodegradable polymeric nature of the inventive stent, the same vessel site can be retreated at a later time if needed, including staging procedures during growth of the patient. Similarly, successive treatments of a tissue that is changing size can be facilitated with the disclosed stent. It should also be noted that the inventive stent can be implanted at a site of healthy tissue for diagnostic purposes or therapeutic treatment of adjacent tissue. [0032] Although preferred embodiments have been described and illustrated, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority to U.S. Provisional Application Ser. No. 62/118,278, filed Feb. 19, 2015, which is herein incorporated by reference in its entirety. BACKGROUND [0002] Often times mobility impairments such as: quadriplegia, cerebral palsy, arthritis, multiple sclerosis, and stroke can impact a person's ability to use their lower extremities as well as their upper extremities. While a wheelchair can be an effective solution to improve mobility for a person with limited lower extremity function, the effectiveness of self-propelling a manual wheelchair can be reduced if a person does not have adequate hand dexterity. Neurological, osteopathic, and or neuro-muscular limitations of the upper extremities, especially of the hands and forearms, are common in cases of spinal cord injury and can make self-propelling a manual wheelchair difficult. Such individuals as well as older or geriatric wheelchair users may find traditional manual wheelchairs difficult to propel due to their decreased ability to grip and push manual wheelchair's smooth plastic or metal hand rims. [0003] To address this problem, the wheelchair industry currently offers rubber coated hand rims as a $300 dollar optional extra on the wheelchair. The rubber coating tends to dry out, crack, deteriorate and become sharp in the user's hands after one year, but it cannot easily be replaced as it involves a long process of removing the tire with special tools that most users do not possess. [0004] In other solutions, as exemplified by U.S. Patent Application Publication 2001/0007389 filed by Carol Frauwirth, a cover uses an adhesive to permanently attach the cover to the hand rims. As a result, the covers are difficult to replace. [0005] Another solution, as exemplified by U.S. Pat. No. 7,040,642 issued to Douglas B. Lowry, describes a substantially ring-shaped sleeve that fits onto a hand rim through an annular gap into a hollow interior. However, the hand rim must align with the diameter of the gap. In other words, the sleeve corresponds to one hand rim diameter. As such, each hand rim diameter must have a corresponding sleeve. [0006] In view of the existing hand rim covers, sleeves and coatings that provide comfort and grip for wheelchair users, there exists a need for a one size fits all hand rim cover that is comfortable, secure, easily installed and easily removed. SUMMARY OF THE INVENTION [0007] A wheelchair hand rim cover is disclosed and generally comprises an elastic loop having a relaxed diameter and cross sectional area, wherein the product of the cross sectional area and modulus of elasticity ranges from about 70 pounds to 180 pounds; a gap extending circumferentially along the elastic loop and corresponding to the hand rim; a first edge and second edge separated by the gap; a hollow interior bounded by an interior wall of the elastic loop; and an exterior surface. [0008] In another embodiment, a wheelchair hand rim cover is disclosed and generally comprises a hand rim including at least one groove disposed around a circumferential ring of the hand rim; the at least one groove includes a longitudinal axis running along the entire circumference of the hand rim; and the at least one groove complimentary fits with the groove of the hand rim cover as to keep the hand rim cover from being axially pushed from the longitudinal axis of the at least one groove. [0009] The methods, systems, and apparatuses are set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of the methods, apparatuses, and systems. The advantages of the methods, apparatuses, and systems will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. 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 methods, apparatuses, and systems, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS [0010] In the accompanying figures, like elements are identified by like reference numerals among the several preferred embodiments of the present invention. [0011] FIGS. 1A and 1B illustrate the relaxed and stretched diameter of one embodiment of the hand rim cover. [0012] FIG. 2 is a cross-sectional view along A-A of one embodiment of the hand rim cover applied to a hand rim. [0013] FIG. 3 illustrates alternative cross sectional geometries of embodiments of the hand rim cover. [0014] FIGS. 4A and 4B illustrate an embodiment of textured features disposed on the outer surface of the hand rim cover. [0015] FIGS. 5A and 5B illustrate an embodiment of the first edge that has a plurality of mounting recesses and further illustrate various number and positions of mounting points the mounting recesses can accommodate. [0016] FIGS. 6A through 6C illustrate on procedure for applying an embodiment of the hand rim cover to a wheelchair hand rim. [0017] FIG. 7A is a perspective view of an alternative embodiment of the hand rim; FIG. 7B is a cross-sectional view of the hand rim coupled with an alternative embodiment of the hand rim cover. [0018] FIGS. 8A-8C are cross-sectional view of alternative embodiments of the hand rim and the hand rim cover. [0019] FIG. 9 is a perspective of alternative embodiments of the hand rim cover. DETAILED DESCRIPTION OF THE INVENTION [0020] The foregoing and other features and advantages of the invention are apparent from the following detailed description of exemplary embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof. [0021] Embodiments of the invention will now be described with reference to the Figures, wherein like numerals reflect like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive way, simply because it is being utilized in conjunction with detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the invention described herein. The words proximal and distal are applied herein to denote specific ends of components of the instrument described herein. A proximal end refers to the end of an instrument nearer to an operator of the instrument when the instrument is being used. A distal end refers to the end of a component further from the operator and extending towards the surgical area of a patient and/or the implant. [0022] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. It will be further understood that the terms “comprises,” “comprising,” “includes,” and/or “including,” when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. [0023] Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. The word “about,” when accompanying a numerical value, is to be construed as indicating a deviation of up to and inclusive of 10% from the stated numerical value. The use of any and all examples, or exemplary language (“e.g.” or “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any nonclaimed element as essential to the practice of the invention. [0024] References to “one embodiment,” “an embodiment,” “example embodiment,” “various embodiments,” etc., may indicate that the embodiment(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase “in one embodiment,” or “in an exemplary embodiment,” do not necessarily refer to the same embodiment, although they may. [0025] In one embodiment, the hand rim cover is an elastic loop that has the property to stretch from a rested diameter to the uncoated rim diameter with no tools. Furthermore, the exemplary embodiment also has a coefficient of static or kinetic friction between the material and the hand rim to prevent slipping during use with only the tension of the material. As such, the same goal is accomplished as permanently coated hand rims, but the exemplary embodiment can be reversibly installed and replaced with no tools and can fit tightly on a wide range of hand rim diameters without requiring tools. One embodiment is made from a significantly softer material than traditional coated hand rims, and provides a significantly more comfortable feel when compared to uncoated and coated hand rims. [0026] In one embodiment, the cover is molded instead of extruded to feature textured and raised surfaces and logos under the hand to provide a better grip for the user. The texture is confined only to the top surface of the grip, and no texture is provided on the outside surface of the hand rim which is commonly used for braking and slowing the wheelchair. Texture there has been found to be disruptive and uncomfortable during the braking process but helpful on the top of the rim when propelling. In the exemplary embodiment, hand rim cover jackets the top and sides of the hand rim. The bottom is left completely bare for smooth braking. [0027] In another embodiment, the hand rim cover is an elastic loop having a relaxed diameter and cross sectional area. The elasticity of the exemplary embodiment is characterized by the product of the material's modulus of elasticity and cross sectional area ranging from about 70 pounds to 180 pounds. The exemplary embodiment has a gap extending circumferentially along the elastic loop that separates a first edge from a second edge. The gap corresponds to the hand rim such that the hand rim can enter through the space between the first and second edge to a hollow interior of the elastic loop through the gap. [0028] In one embodiment, the hand rim cover is an elastic loop with a relaxed diameter ranging from about 17 inches to about 20 inches. In the exemplary embodiment, the elastic loop is able to stretch from the relaxed diameter to fit wheelchairs having nominal wheel diameters ranging from 24 to 26 inches, or hand rims with outside diameters ranging from 20.0 to 22.8 inches. [0029] In another embodiment, the hand rim cover is an elastic loop with a relaxed diameter ranging from about 13 inches to about 18 inches. In the exemplary embodiment, the elastic loop is able to stretch from the relaxed diameter to accommodate pediatric sized wheelchair wheels. [0030] In one embodiment, the cross sectional area of the hand rim cover has a center line defined by the boundary where substantially equal amounts of material comprise each side of the line. [0031] In another embodiment, the hand rim cover has an apex circumferentially disposed on the outer surface of the elastic loop. [0032] In another embodiment, the apex is disposed off the center line towards the wheel. [0033] In one embodiment, the apex has a thickness defined between the interior wall and the highest point of the apex ranging from about 0.15 inches to about 0.45 inches. [0034] In one embodiment, the hand rim cover has a Type A Shore Durometer hardness ranging from about 30 Shore to about 70 Shore. [0035] In another embodiment, the hand rim cover has a surface roughness of at least about 30 Ra micro-inches. [0036] In one embodiment, the hand rim cover has a coefficient of static or kinetic friction between the interior wall and the hand rim of at least about 0.01 and about 0.39. [0037] In one embodiment, the first edge is a series of mount recesses that are evenly distributed circumferentially. [0038] In one embodiment there are 72 mount recesses equally spaced around the circle. [0039] In one embodiment, the hand rim cover is an elastic loop that has a stretched diameter. The upper limit of the stretched diameter of the exemplary embodiment is greater than about 125% of the relaxed diameter. [0040] In one embodiment the hand rim cover has significantly more material is disposed on top of the hand rim than the side of the hand rim to provide greater comfort when gripped by the user. [0041] In another embodiment the hand rim cover has textured features disposed on the outer surface of the hand rim cover to provide improved grip. In an exemplary embodiment, the textured features are disposed only on the top section of the outer surface to provide a smooth braking surface on the side sections of the hand rim cover. [0042] Generally speaking, a hand rim for a 24 inch wheelchair wheel is usually in the range of 19.5-21.5 inches in diameter. 26 inch wheels have hand rims 21.5-22.5 inches in diameter. Size is stated relative to the wheel size in the wheelchair. As such, embodiments described herein fit on a hand rim for a stated wheel diameter, not for a specific hand rim size. This is consistent with industry practice as manufacturers and retailers only list the diameter of the wheel to which the hand rim attaches. [0043] In an embodiment as shown in FIG. 1A , the hand rim cover 100 is an elastic loop 110 , which has a relaxed diameter 112 and a stretched diameter 114 . In an exemplary embodiment, the stretched diameter 114 accommodates various hand rims corresponding to wheelchair wheel sizes. An exemplary embodiment, as shown in FIG. 1B , illustrates elastic loop 110 expanded to a stretched diameter 112 to accommodate the diameter of the hand rim. The elasticity of the elastic loop 110 provides a normal force on the hand rim surface such that the coefficient of static or kinetic friction between the hand rim 140 and interior wall 120 , as shown in FIG. 2 , provide a frictional force to prevent the elastic loop from slipping in use. In one embodiment, the elasticity is characterized by the product of the modulus of elasticity and cross sectional area of the loop. In an exemplary embodiment, the product of the modulus of elasticity and cross sectional area of the loop ranges from about 50 pounds to about 200 pounds. A more preferred range is from about 70 pounds to about 180 pounds. In the exemplary embodiment, the coefficient of static or kinetic friction is at least about 0.3. A more preferred limit is at least about 0.39, alternatively between about 0.01 and 0.04. In one embodiment the stretched diameter 114 has an upper limit of stretching to a diameter of about 130% the relaxed diameter 112 . In a preferred embodiment, the stretched diameter 114 has an upper limit of stretching to a diameter of about 125% the relaxed diameter 112 . A more preferred upper limit of stretching is about 123% the relaxed diameter. [0044] Embodiments using different hand rim cover 100 materials having material properties resulting in various elasticity and various coefficients of static or kinetic friction with various hand rim 140 materials are fully contemplated as long as the coefficient of static or kinetic friction and the product of the cross sectional area with the modulus of elasticity are within acceptable ranges preventing slippage during use. [0045] In one embodiment, the relaxed diameter 112 ranges from about 17 inches to about 20 inches, wherein any loop diameter within the range can stretch to accommodate wheelchair wheel sizes between 24 and 26 inches. In another embodiment, the relaxed diameter 112 ranges from about 13 inches to 18 inches to accommodate pediatric size wheelchair wheel diameters 20 and 22 inches, wherein any loop diameter within the range can stretch to fit the pediatric size wheelchair wheel diameters. [0046] In one embodiment, the hand rim cover 100 is an elastic loop 110 having a hardness that is comfortable to touch and grip. In an exemplary embodiment, the hardness of elastic loop 110 is measured by a Shore durometer type A scale and has a durometer ranging from about 25 Shore A to about 75 Shore A. A more preferred hardness of elastic loop 110 ranges from about 30 Shore A to about 70 Shore A. [0047] In an embodiment, the hand rim cover 100 is an elastic loop 110 having a surface roughness suitable to hide the feeling of dirt, dust and grit. In one embodiment, the surface roughness has an arithmetic average roughness (R a ) at least about 30 μ-inches. A preferred surface roughness is at least about 32 μ-inches. [0048] To provide secure and uniform circumferential contact between the outer surface of hand rim 140 and substantially the entire surface of interior wall 120 , as shown in FIG. 2 , one embodiment of the hand rim cover 100 , is an elastic loop 110 that includes a hollow interior 122 having a dimension complementing the outer surface of hand rim 140 . In an exemplary embodiment as shown in FIG. 2 , the hand rim 140 enters the hollow interior 122 through a gap 124 that is circumferentially disposed along the elastic loop 110 . In the exemplary embodiment, the gap 124 provides separation between a first edge 126 and second edge 128 such that the space provided by the gap 124 limits coverage to the top and side portions of hand rim 140 . In this embodiment, the bottom of hand rim 140 is left uncovered for smooth braking. In another embodiment not shown, the space provided by gap 124 results in the second edge 128 extending to cover the bottom portion of hand rim 140 . [0049] As shown in FIG. 2 , the cross sectional view of hand rim cover 100 has a center line 132 . In one embodiment, as shown in FIG. 2 , the center line 132 is defined as the edge of a plane that divides the cross section of hand rim cover 100 into substantially equal amounts of material on each side. The center line 132 as shown in FIG. 2 , although asymmetric, represents that the amount of material on the left and right side of center line 132 is equal. In one embodiment, the hand rim cover 100 is an elastic loop wherein center line 132 divides elastic material of the elastic loop 110 into equal portions on each side of the center line 132 . In other embodiments not shown, it is fully contemplated that the center line 132 is an axis of symmetry. In the embodiment as shown in FIG. 2 , center line 132 is collinear with the z-axis of hand rim 140 . [0050] In one embodiment, as shown in FIG. 2 , the hand rim cover 100 includes an apex 134 circumferentially disposed on the outer surface of the hand rim cover 100 . The apex 134 may be disposed such that the peak of the apex 134 is aligned with the center line 132 . In an exemplary embodiment, as shown in FIG. 2 , the peak of the apex 134 is off set toward the wheelchair wheel. The offset toward the wheelchair wheel functions to prevent the hand of the user from contacting any sharp edges that may result from the parting line during molding of the hand rim cover 100 . The apex 134 has a thickness disposed between the peak of apex 134 to the interior wall 120 . In one embodiment the thickness ranges from about 0.1 inches to about 1 inch. A more preferred thickness ranges from about 0.1 inches to 0.5 inches. The most preferred thickness ranges from about 0.15 inches to about 0.45 inches. As shown in FIG. 2 , significantly more material comprising the hand rim cover 100 is on the top of the hand rim to provide a comfortable cushion under the hand of the user. FIG. 3 depicts various embodiments of the hand rim cover 100 having a several different cross-sectional geometries. While the top left drawing is the most preferred embodiment, the other cross sections have pros and cons associated with them for users with different injury types and, therefore, different styles of grip. The profiles in the center column all have the thickest section right on the top which is good for comfort, but most manufacturing processes will leave a small ridge directly under the most sensitive portions of the hand. The profiles on the right column have added cushion directly under the top right quarter which is great for users with quadriplegia, but not as comfortable for other injury types. The cross sections at the bottom of the page feature a longer cross section top to bottom which fits a wide variety of hands and tends to be more comfortable, but they use quite a bit more material which makes them expensive to manufacture. Some of the grip profiles have coverage over more of the hand rim than others which can be good for enhanced grip but detrimental during braking. All wheelchair users have a slightly different style of grip when using a wheelchair, and selected to optimize balance of comfort, manufacturability, power, and braking. [0051] In one embodiment, as shown in FIGS. 4A and 4B , textured features 150 are disposed on the outside surface of the hand rim cover 100 . The textured features 150 function to provide greater grip for the user. In an exemplary embodiment, the textured features 150 are confined to only the top surface of the hand rim cover 100 . The side portion of hand rim cover 100 is commonly used by an individual for braking and slowing the wheelchair by hand. As such, disposition of the textured features 150 to the top portion of the hand rim cover 100 functions to provides a smooth comfortable surface for braking. Textured features 150 can include any geometry and/or includes logos comprised of any symbols and/or text. [0052] As shown in FIGS. 1 and 5A , one embodiment of the first edge 126 of hand rim 100 has a plurality of mounting recesses 127 . In one embodiment, as shown in FIGS. 5B , the mounting recesses 127 correspond to positions, referred to herein as mounting points, where the hand rim 140 is mounted to the wheelchair wheel. The mounting recesses 127 function to accommodate the mounting points to further secure the hand rim cover 100 and prevent slippage during use in addition to frictional forces. In one embodiment, the mounting recesses 127 are evenly distributed circumferentially along the first edge 126 . In an exemplary embodiment, the disposition of evenly distributed mounting recesses 127 accommodates 6, 8 or 9 mounting points equally spaced around the circle. In one embodiment, the first edge 126 has 72 evenly distributed mounting recesses 127 . [0053] As shown in FIGS. 6A-6C , an exemplary embodiment of the hand rim cover 100 as an elastic loop 110 is applied to a hand rim. As illustrated, initially, the elastic loop 110 covers the hand rim 140 such that the hand rim 140 enters gap 124 in to hollow interior 122 at a section of the hand rim 140 . Once secured, the elastic loop 110 is stretched to house the remaining sections such that the mounting points on the hand rim are secured in the mounting recesses 127 of the hand rim until the entirety of the hand rim is covered for use as shown in FIG. 5C . [0054] In an alternative embodiment, the hand rim 140 , as shown in FIGS. 7A-7B , includes at least one groove 142 disposed around the entire the circumferential ring 144 of the hand rim 140 . The at least one groove includes a longitudinal axis running along the entire circumference of the hand rim 140 . The at least one groove 142 complimentary fits with the groove of the hand rim cover 200 , as shown in FIGS. 8A-8C , as to keep the hand rim cover from rotating or being axially pushed from the longitudinal axis of the at least one groove. [0055] The circumferential ring 144 of the hand rim 140 includes a profile or cross-section disposed with the thickness, as shown in FIG. 7B . The at least one groove 142 is disposed at a depth D into the profile of the circumferential ring 144 . The at least one groove 142 includes a cross section or profile that is generally V-shaped. Alternatively, the at least one groove 142 may include alternative cross-sections or profiles such as square shaped, U shaped, trapezoidal shaped, polygonal shaped, rectangular shaped, or keyway shaped. In one embodiment, the depth D may be between 0.1 inches to about 2.0 inches, alternatively, the depth D may be between 0.1 and 0.5 inches. The depth D may be selected based upon type of hand rim cover being used and degree of rotation and pull on the hand rim cover. For example, a greater depth D may be selected for a thicker hand rim cover or a greater degree of rotation and pull of the hand rim cover. The at least one groove 142 also includes an angle A formed by at least two wall surfaces 146 . The angle A may be between 25 and 75 degrees. The angle A may be selected based upon the degree of rotation and pull on the hand rim cover. For example, a larger angle A may be selected for a thicker hand rim cover or a greater degree of rotation and pull of the hand rim cover. [0056] The wall surface 146 of each groove 142 may be substantially smooth, such as illustrated in FIG. 7B , or wall surface 146 may be jagged, or roughened, as to prevent longitudinal movement of the hand rim cover 200 during external pressure or force. The wall surface 146 could also be provided with at least one axial indentation if desired, and a complementary axial protrusion for the hand rim cover could be provided as to prevent longitudinal movement of the hand rim cover 200 during external pressure or force. [0057] As shown in FIG. 7B , the groove 142 includes a width W that traverses an imaginary line from a circumferential surface 148 of the circumferential ring 144 . The hand rim cover 200 includes an outer width W 2 , as shown in FIG. 8A , to sufficiently plug or fill the outer width W of the at least one groove 142 to provide a grip or traction for the user. [0058] As shown in FIG. 8A , the hand rim cover 200 is shown operably coupled to the hand rim 120 . The hand rim cover 200 includes at least one protrusion 210 extending around the entire inner circumferential ring of the hand rim cover 200 . The at least one protrusion 210 includes an inner wall surface 214 and is complimentary and fits into the at least one groove 142 , whereby a user grips the outer circumferential ring 212 when the hand rim cover 200 is engaged with the at least one groove 142 of the hand rim 120 . The at least one protrusion 210 includes a cross section or profile that is generally V-shaped. Alternatively, the at least one protrusion 210 may include alternative cross-sections or profiles as to be complimentary to the at least one groove 142 , such as square shaped, U shaped, trapezoidal shaped, polygonal shaped, rectangular shaped, or keyway shaped. In one embodiment, the at least one protrusion 210 includes a depth D 2 , which is complimentary to the depth D of the at least one groove 142 , which may be between 0.1 inches to about 0.5 inches; alternatively the depth may be between 0.1 and 2.0 inches. As such, the depth D 2 may be selected based upon type of hand rim cover 200 being used and degree of rotation and pull on the hand rim cover. For example, a greater depth D 2 may be selected for a thicker hand rim cover or a greater degree of rotation and pull of the hand rim cover. The at least one protrusion 210 also includes an angle A 2 which is complimentary to the angle A of the at least one groove 142 . In one embodiment, the angle A 2 may be between 5 and 60 degrees. The angle A 2 may be selected based upon the degree of rotation and pull on the hand rim cover. For example, a larger angle A may be selected for a thicker hand rim cover or a greater degree of rotation and pull of the hand rim cover. [0059] In one embodiment, the hand rim cover 200 may include a low profile when engaged with the hand rim 140 , as shown in FIG. 8A . The outer width W 2 of the hand rim cover 200 sufficiently traverses and fills the width W of the at least one groove 142 . The outer width W 2 traverses and completes the circumferential surface 148 at the outer width W as to allow for a low profile of the hand rim cover 200 . In one embodiment, the at least one protrusion includes at least two inner wall surfaces 214 that substantially abut and engage the wall surfaces 146 of the at least one groove 142 . In one embodiment, the inner wall surfaces 214 may include a coefficient of static or kinetic friction between the wall surface 146 of the groove 142 to prevent slipping during use with only the tension of the material, as previously described. Alternatively, a non-permanent glue may be used to seal the wall surfaces 214 of the hand rim cover 200 to the wall surface 146 of each groove 142 . [0060] As shown in FIG. 8B , an alternative hand rim cover 300 includes an alternative profile whereby the circumferential ring 212 of the hand rim cover 220 substantially covers the circumferential surface 148 of the hand rim 120 . The circumferential ring 212 includes at least two covering portions 222 that cover the circumferential surface 148 on both sides of the at least one groove 142 . The circumferential ring 212 includes a substantially curved portion as to match the curvature of the circumferential surface 148 . In one embodiment, the circumferential ring 212 includes a textured outer surface 228 for additional gripping capabilities for the user, as shown in FIG. 9 . In one embodiment, the two covering portions 222 may include a coefficient of static or kinetic friction with the circumferential surface 148 of the hand rim 120 to prevent slipping during use with only the tension of the material, as previously described. [0061] As shown in FIG. 8C , an alternative hand rim cover 300 includes an alternative profile whereby the circumferential ring 312 includes a first covering portion 322 and a second covering portion 324 . The second covering portion 324 extends along a second side 123 of the hand rim 120 , and the first covering portion 322 extends along a first side 121 of the hand rim 120 . The second covering portion 324 and the first covering portion 322 allow for a wider grip area and increased surface area, so a user may control the hand rim cover 300 with almost any part of the hand. [0062] As shown in FIG. 9 , the hand rim 120 with the groove 142 showing alternative profiles or cross-sections of the hand rim covers that can be interchanged. In one embodiment, the hand rim cover 400 may include a winged portion 420 extending from the circumferential ring 412 . The hand rim cover 400 may include only a first covering portion 422 extending around at least half of the circumference of the hand rim. In one embodiment, the hand rim cover 500 includes a circumferential ring 512 including a first covering portion 522 with a substantially flat side 523 . The hand rim cover 500 includes a second covering portion 524 extending around more than half of the circumference of the hand rim 120 . [0063] While the invention has been described in connection with various embodiments, it will be understood that the invention is capable of further modifications. This application is intended to cover any variations, uses or adaptations of the invention following, in general, the principles of the invention, and including such departures from the present disclosure as, within the known and customary practice within the art to which the invention pertains.

1a

BACKGROUND-CROSS-REFERENCES TO RELATED APPLICATION [0001] This application claims the benefit of Provisional Patent Application Ser. No.: 60/229151 filed on Aug. 30, 2000. FIELD OF THE INVENTION [0002] The present invention relates to novel compositions of matter containing optically pure enantiomers of S-adenosyl-l-methionine. These compositions possess potent activity in treating various conditions involving hypomethylation and transulfuration reactions. TECHNICAL FIELD [0003] This patent relates to novel compositions of matter containing optically pure enantiomers of S-adenosyl-l-methionine (SAM-e) and to therapeutic uses of these new compositions. More particularly, the invention relates to the substantially optically pure enantiomer (S,S)-S-adenosylmethionine, pharmaceutically acceptable salts and pharmaceutical compositions that contain them as active principles. BACKGROUND OF THE INVENTION [0004] Many organic compounds exist in optically active forms, i.e., they have the ability to rotate the plane of plane-polarized light. In describing an optically active compound, the prefixes D and L or R and S are used to denote the absolute configuration of the molecule about its chiral center. [0005] The prefixes d and l or (+) and (−) are employed to designate the sign of rotation of planepolarized light by the compound, with (−) or l meaning that the compound is levorotatory. A compound prefixed with (+) or d is dextrorotatory. For a given chemical structure, these compounds, called stereoisomers, are identical except that they are mirror images of one another. A specific stereoisomer may also be referred to as an enantiomer, and a mixture of such isomers is often called an enantiomeric mixture. A 50:50 mixture of enantiomers is referred to as a racemic mixture. [0006] Stereochemical purity is of importance in the field of pharmaceuticals, where 12 of the 20 most prescribed drugs exhibit chirality. A case in point is provided by the L-form of the betaadrenergic blocking agent, propranolol, which is known to be 100 times more potent than the D-enantiomer. [0007] Furthermore, optical purity is important since certain isomers may actually be deleterious rather than simply inert. For example, it has been suggested that the D-enantiomer of thalidomide was a safe and effective sedative when prescribed for the control of morning sickness during pregnancy, and that the corresponding L-enantiomer was a potent teratogen. [0008] S-adenosyl-l-methionine is a naturally occurring substance that is present in all living organisms and has a number of very important biological functions. Among these functions are the following: methyl group donor in transmethylation reactions (it is the sole methyl group donor in such reactions-including methylation of DNA, proteins, hormones, catechol and indoleamines and phosphatidylethanolamine to phosphatidylcholine); it is a substrate of an enzyme lyase that converts S-adenosyl-l-methionine to the molecule methylthioadenosine and homoserine; it is an aminobutyric chain donor to tRNA; it is an aminoacidic chain donor in the biosynthesis of biotin; SAM-e, after decarboxylation, is the donor of aminopropyl groups for the biosynthesis of neuroregulatory polyamines spermidine and spermine. (Zappia et al (1979), Biomedical and Pharmacologcial roles of Adenosylmethionine and the Central Nervous System, page 1, Pergamon Press. N.Y.) [0009] SAM-e has been used clinically in the treatment of liver disease (Friedel H, Goa, K. L., and Benfield P., (1989), S-Adenosyl-l-methionine: a review of its pharmacological properties and therapeutic potential in liver dysfunction and affective disorders in relation to its physiological role in cell metabolism. Drugs. 38, 389-416), arthritis (Di Padova C, (1987), S-adenosyl-l-methionine in the treatment of osteoarthritis: review of the clinical studies. Am J. Med. 83, (Suppl. 5), 6-65), and depression (Kagan, B, Sultzer D. L., Rosenlicht N and Gerner R. (1990), Oral S-adenosylmethionine in depression: a randomized, double blind, placebo-controlled trial. Am. J. Psychiatry 147, 591-595.) Alzheimer's patients have reduced cerebral spinal fluid levels of S-adenosyl-l-methionine (Bottiglieri et al, (1990), Cerebrospinal fluid S-adenosyl-l-methionine in depression and dementia: effects of treatment with parenteral and oral S-adenosyl-l-methionine. J. Neurol. Neurosurg. Psychiatry 53, 1096-1098.) In a preliminary study, SAM-e was able to produce cognitive improvement in patients with Alzheimer's disease. (Bottiglieri et al (1994), The clinical potential of admetionine (S-adenosyl-l-methioinine) in neurological disorders. Drugs 48, 137-152.) SAM-e brain levels in patients with Alzheimer's disease are also severely decreased. (Morrison et al, (1996), Brain S-adenosylmethionine levels are severely decreased in Alzheimer's disease, Journal of Neurochemistry, 67, 1328-1331.) Patients with Parkinson's disease have also been shown to have significantly decreased blood levels of SAM-e. (Cheng et al, (1997), Levels of L-methionine S-adenosyltransferase activity in erythrocytes and concentrations of S-adenosylmethionine and S-adenosylhomocysteine in whole blood of patients with Parkinson's disease. Experimental Neurology 145, 580-585.) [0010] SAM-e levels in patients treated with the antineoplastic drug methotrexate are reduced. Neurotoxicity associated with this drug may be attenuated by co-administration of SAM-e. (Bottiglieri et al (1994), The Clinical Potential of Ademetionine (S-adenosylmethionine) in neurological disorders, Drugs, 48 (2), 137-152.) [0011] Cerebral spinal fluid levels of SAM-e have been investigated in HIV AIDS dementia Complex/HIV encephalopathy and found to be significantly lower than in non-HIV infected patients. (Keating et al (1991), Evidence of brain methyltransferase inhibition and early brain involvement in HIV positive patients Lancet: 337:935-9.) [0012] De La Cruz et al have shown that SAM-e, chronically administered, can modify the oxidative status in the brain by enhancing anti-oxidative defenses. (De La Cruz et al, (2000), Effects of chronic administration of S-adenosyl-l-methionine on brain oxidative stress in rats. Naunyn-Schmiedeberg's Archives Pharmacol 361: 47-52.) This is similar to results obtained with SAM-e in liver and kidney tissue. Thus SAM-e would be useful as an antioxidant. [0013] Oral SAM-e administration to patients with and without liver disease has resulted in increases in liver glutathione levels. (Vendemiale G et al, (1989), Effect of oral S-adenosyl-l-methionine on hepatic glutathione in patients with liver disease. Scand J Gastroenterol; 24: 407-15. Oral administration of SAM-e to patients suffering from intrahepatic cholestasis had improvements in both the pruritus as well as the biochemical markers of cholestasis. (Giudici et al, The use of admethionine (SAM-e) in the treatment of cholestatic liver disorders. Meta-analysis of clinical trials. In: Mato et al editors. Methionine Metabolism: Molecular Mechanism and Clinical Implications. Madrid: CSIC Press; 1992 pp 67-79.) Oral SAM-e administration to patients suffering from primary fibromyalgia resulted in significant improvement after a short term trial. (Tavoni et al, Evaluation of S-adenosylmethioine in Primary Fibromaylgia. The American Journal of Medicine, Vol 83 (suppl 5A), pp 107-110, 1987.) SAM-e has been used for the treatment of osteoarthritis as well. (Koenig B. A long-term (two years) clinical trial with S-adenosylmethionine for the treatment of osteoarthritis. The American Journal of Medicine, Vol 83 (suppl 5A), Nov. 20, 1987 pp 89-94) [0014] SAM-e is clinically useful in many apparently unrelated areas because of its important function in basic metabolic processes. One of its most striking clinical uses is in the treatment of alcoholic liver cirrhosis that, until now, remained medically untreatable. Mato et al demonstrated the ability of oral SAM-e in alcoholic liver cirrhosis to decrease the overall mortality and/or progression to liver transplant by 29% vs 12% as compared with a placebo treated group. (Mato et al (1999), S-adenosylmethionine in alcohol liver cirrhosis: a randomized, placebo-controlled, double blind, multi-center clinical trial, Journal of Hepatology, 30, 1081-1089.) [0015] Sam-e also attenuates the damage caused by tumor necrosis factor alpha and can also decrease the amount of tumor necrosis factor alpha secreted by cells. Consequently, conditions in which this particular inflammatory factor is elevated would benefit from the administration of SAM-e. (Watson WH, Zhao Y, Chawla RK, (1999) Biochem J Aug. 15; 342 (Pt 1):21-5. S-adenosylmethionine attenuates the lipopolysaccharide-induced expression of the gene for tumour necrosis factor alpha.) SAM-e has also been studied for its ability to reduce the toxicity associated with administration of cyclosporine A, a powerful immunosuppressor. (Galan A, et al, Cyclosporine A toxicity and effect of the s-adenosylmethionine, Ars Pharmaceutica, 40:3; 151-163, 1999.) [0016] SAM-e, incubated in vitro with human erythrocytes, penetrates the cell membrane and increases ATP within the cell thus restoring the cell shape. (Friedel et al, S-adenosyl-l-methionine: A review of its pharmacological properties and therapeutic potential in liver dysfunction and affective disorders in relation to its physiological role in cell metabolism, Drugs 38 (3):389-416, 1989) [0017] SAM-e has been studied in patients suffering from migraines and found to be of benefit. (Friedel et al, S-adenosyl-l-methionine: A review of its pharmacological properties and therapeutic potential in liver dysfunction and affective disorders in relation to its physiological role in cell metabolism, Drugs 38 (3): 389-416, 1989) [0018] SAM-e has been administered to patients with peripheral occlusive arterial disease and was shown to reduce blood viscosity, chiefly via its effect on erythrocyte deformability. [0019] SAM-e is commercially available using fermentation technologies that result in SAM-e formulations varying between 60 and 80% purity. (That is, the final product contains 60-80% of the active or (S, S)-SAM-e and 20-40% of the inactive or (R, S) -SAM-e.) (Gross, A., Geresh, S., and Whitesides, Gm (1983) Appl. Biochem. Biotech. 8, 415.) Enzymatic synthetic methodologies have been reported to yield the inactive isomer in concentrations exceeding 60%. (Matos, JR, Rauschel FM, Wong, CH. S-Adenosylmethionine: Studies on Chemical and Enzymatic Synthesis. Biotechnology and Applied Biochemistry 9, 39-52 (1987). Enantiomeric separation technologies have been reported to resolve the pure active enantiomer of SAM-e. (Matos, JR, Rauschel FM, Wong, CH. S-Adenosylmethionine: Studies on Chemical and Enzymatic Synthesis. Biotechnology and Applied Biochemistry 9, 39-52 (1987; Hoffman, Chromatographic Analysis of the Chiral and Covalent Instability of S-adenosyl-l-methionine, Biochemistry 1986, 25 4444-4449: Segal D and Eichler D, The Specificity of Interaction between S-adenosyl-l-methionine and a nucleolar 2-0-methyltransferase, Archives of Biochemistry and Biophysics, Vol. 275, No. 2, December, pp. 334-343, 1989) Newer separation technologies exist to resolve enantiomers on a large commercial production scale at a very economic cost. In addition, it would be conceivable to synthesize the biologically active enantiomer using special sterioselective methodologies but this has not been accomplished to date. [0020] De la Haba first showed that the sulfur is chiral and that only one of the two possible configurations was synthesized and used biologically. (De la Haba et al J. Am. Chem. Soc. 81, 3975-3980, 1959) Methylation of RNA and DNA is essential for normal cellular growth. This methylation is carried out using SAM-e as the sole or major methyl donor with the reaction being carried out by a methyltransferase enzyme. Segal and Eichler showed that the enzyme bound (S, S)-SAM-e 10 fold more tightly than the biologically inactive (R, S)-SAM-e thus demonstrating a novel binding stereospecificity at the sulfur chiral center. Other methyltransferases have been reported to bind (R, S)-SAM-e to the same extent as (S, S)-SAM-e and thus (R, S)-SAM-e could act as a competitive inhibitor of that enzyme. (Segal D and Eichler D, The Specificity of Interaction between S-adenosyl-l-methionine and a nucleolar 2-0-methyltransferase, Archives of Biochemistry and Biophysics, Vol. 275, No. 2, December pp. 334-343, 1989; Borchardt RT and Wu YS , Potential inhibitors of S-adenosylmethionine-dependent methyltransferases. Role of the Asymmetric Sulfonium Pole in the Enzymatic binding of S-adenosyl-l-methionine, Journal of Medicinal Chemistry, 1976, Vol 19, No. 9, 1099-1103.) [0021] SAM-e (whether in its optically pure enantiomeric form or in an enantiomeric or racemic mixture) presents certain difficult problems in terms of its stability at ambient temperature that result in degradation of the molecule to undesirable degradation products. SAM-e (and thus its enantiomers) must be further stabilized since it exhibits intramolecular instability that causes the destabilization and breakdown of the molecule at both high as well as ambient temperatures. SAM-e has therefore been the subject of many patents directed both towards obtaining new stable salts, and towards the provision of preparation processes that can be implemented on an industrial scale. The present patent thus envisions the use of any of the salts of SAM-e already disclosed in the prior art to stabilize the enantiomeric forms of SAM-e. PRIOR ART [0022] Many patents exist disclosing salts of SAM-e that stabilize the molecule but none discloses the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 2,969,353, Shunk et al, Jan. 24, 1962, discloses a method for the preparation of Sam-e and a stable salt of SAM-e but not the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 3,707,536, Haid et al, Dec. 26, 1972, discloses a new SAM-e bisulfate salt but not the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 3,893,999, Fiecchi, Jul. 8, 1975, discloses a new salt of SAM-e made with tri-p-toluensulphonate but not the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 5,102,791, Gennari, Apr. 7, 1992, discloses, among others, a 1,4 butanedisulfonate salt of SAM-e but not the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,028,183, Fiecchi, Jun. 7, 1977, discloses, among others, p-toluene sulfonate as a means to stabilize the SAM-e molecule but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No.4,764,603, Zappia, Aug. 16, 1988, discloses the use of polyanions such as polyphosphates, polyvinylsulfonates-sulfates or phosphates, polyacrylates, and polystyrene sulfonates. However, this patent does not disclose the use of an optically pure enantiomer of SAM-e. [0023] U.S. Pat. No. 6,117,849, Zimmermann, et al. Sep. 12, 2000, discloses the use of SAM-e complexed with nucleosides as HIV inhibitors but does not disclose the use of an optically pure enantiomer of SAM-e for any other condition nor the enantiomer of SAM-e uncomplexed to another molecule. U.S. Pat. No. 4,465,672, Gennari, Aug. 14, 1984, discloses new SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 3,954,726, Fiecchi, May 4, 1976, discloses double salts of SAM-e but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,057,686, Fiecchi, Nov. 8, 1977, discloses stable salts of SAM-e but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,109,079 Kawahara, et al., Aug. 22, 1978, discloses new stable SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,242,505, Kawahara, et al. Dec. 30, 1980, discloses new stabilizing salts of SAM-e but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,369,177, Kozaki, et al. Jan. 18, 1983, discloses new stable SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,543,408, Gennari, Sep. 24, 1985, discloses new SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,558,122, Gennari, Dec. 10, 1985, discloses new SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,764,603, Zappia, et al. Aug. 16, 1988, discloses the use of new salts of SAM-e but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 4,990,606, Gennari, Feb. 5, 1991, discloses new salts of SAM-e but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 5,073,546, Zappia, et al. Dec. 17, 1991, discloses new salts of SAM-e but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 5,114,931, Gennari, May 19, 1992, discloses injectable SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 5,128,249, Gennari, Jul. 7, 1992, discloses new SAM-e salts but does not disclose the use of an optically pure enantiomer of SAM-e. U.S. Pat. No. 5,196,402, Braganza, et al. Mar. 23, 1993, discloses the use of SAM-e for certain clinical uses but does not disclose the use of an optically pure enantiomer of SAM-e. [0024] U.S. Pat. No. 5,466,678, Kawabata, et al. Nov. 14, 1995, discloses the use SAM-e to decrease the side effects of chemotherapy but does not disclose the use of an optically pure enantiomer of SAM-e to accomplish this. U.S. Pat. No. 5,137,712, Kask et al, Aug. 11, 1992 discloses the use of SAM-e to reverse or prevent side effects of neuroleptic treatment but does not disclose the use of an optically pure enantiomer of SAM-e. [0025] Administration of optically pure enantiomers of SAM-e salts of the present invention would have significant utility over a wide range of disorders or conditions associated with low levels of SAM-e. Since the two enantiomeric forms of S-adenosyl-l-methionine do not exhibit the same biological activity but rather that the (R, S) S-adenosyl-l-methionine enantiomer exhibits no biological activity (or even competitive inhibition), it is therefore necessary for a rational pharmaceutical therapy to use the more active enantiomeric form of S-adenosyl-l methionine. In this regard, and in view of the (R, S)-SAM-e enantiomer to act as a competitive inhibitor of (S, S,) SAM-e in methyltransferase reactions, a more ideal SAM-e composition would be the substantially optically pure biologically active (S, S)-SAM-e form. [0026] It is an object of the present invention to provide new compositions of SAM-e containing substantially pure biologically active (S, S) SAM-e. It is a further object of the present invention to provide such compositions that provide treatment or prevention of conditions that are related to lowering SAM-e levels. It is a still further object of the present invention to provide such compositions having good stability. [0027] Accordingly, there is need in the art for new, substantially optically pure enantiomeric forms of SAM-e as well as methods related to the use of such substantially optically pure enantiomeric forms of SAM-e to increase blood and other tissue and fluid levels of SAM-e and to treat conditions which result from low blood and tissue levels of SAM-e. The author of this present invention fulfills these needs, and provides further related advantages. SUMMARY OF THE INVENTION [0028] Briefly stated, the present invention discloses compositions of substantially optically pure enantiomeric forms of SAM-e, and methods for the use thereof. These new substantially optically pure enantiomeric forms of SAM-e of this present invention have utility in increasing blood and other tissue or fluid levels of SAM-e, as well as treating or preventing a wide variety of conditions associated with low blood or other tissue or fluid levels of SAM-e and inhibit tumor necrosis factor alpha. Thus in one embodiment, a substantially optically pure enantiomeric form of SAM-e salt is administered to a warm-blooded animal in need thereof to increase SAM-e levels. In another embodiment, a substantially optically pure enantiomeric form of SAM-e salt is administered to a warm-blooded animal in need thereof to prevent or treat a condition associated with low levels of SAM-e. In yet a further embodiment, a substantially optically pure enantiomeric form of SAM-e salt is administered to a warm blooded animal to prevent and or treat the following conditions: aging, aging of the skin, Alzheimer's disease, rheumatoid arthritis, osteoarthritis, both as an anti-inflammatory as well as to promote new cartilage formation, cancer, conditions of hypomethylation, mitochondrial diseases, hypomethylation of DNA and RNA, nerve damage associated with HIV/AIDS, anxiety, attention deficit disorder and ADHD, sleep regulation, organ preservation for transplant industry, dyslipidemias, excess sebum production, migraines, bile dysfunction caused by pregnancy and use of contraceptive medications, depression, acute and chronic liver disease, cirrhosis of the liver, ischemic reperfusion injury, Parkinson's disease, memory disturbances, memory loss, pancreatitis, intrahepatic cholestasis, inflammation, pain, side effects of administration of chemotherapy, liver disease associated with administration of total parenteral nutrition, liver dysfunction, low tissue levels of glutathione, administration of neuroleptic drugs, administration of cyclosporin A, asthma, alcohol withdrawal, DETAILED DESCRIPTION OF THE INVENTION [0029] As mentioned above, this invention is generally directed to compositions of a substantially optically pure enantiomeric form of SAM-e salts. Such new optically pure enantiomeric forms of SAM-e salts, when administered to a warm blooded animal in need thereof, have utility in the prevention or treatment of conditions associated with low levels of SAM-e in warm blooded animals, including humans. [0030] As used herein, the term “conditions” includes diseases, injuries, disorders, indications and/or afflictions that are associated with decreased levels of SAM-e. The term “treat” or “treatment” means that the symptoms associated with one or more conditions associated with low levels of SAM-e are alleviated or reduced in severity or frequency and the term “prevent” means that subsequent occurrences of such symptoms are avoided or that the frequency between such occurrences is prolonged. [0031] The substantially optically pure enantiomeric forms of SAM-e salts of this invention may be used to prevent and/or treat a variety of conditions associated with lowered levels of SAM-e. Due to its ubiquitous distribution in mammalian tissue, SAM-e is associated with a variety of conditions: aging, aging of the skin, Alzheimer's disease, rheumatoid arthritis, osteoarthritis, both as an anti-inflammatory as well as to promote new cartilage formation, cancer, conditions of hypomethylation, mitochondrial diseases, hypomethylation of DNA and RNA, HIV/AIDS, anxiety, attention deficit disorder and ADHD, sleep regulation, organ preservation for transplant industry, dyslipidemias, excess sebum production, migraines, bile dysfunction caused by pregnancy and use of contraceptive medications, depression, acute and chronic liver disease, cirrhosis of the liver, ischemic reperfusion injury, Parkinson's disease, memory disturbances, memory loss, pancreatitis, intrahepatic cholestasis, inflammation, pain, side effects of administration of chemotherapy, liver disease associated with administration of total parenteral nutrition, liver dysfunction, low tissue levels of glutathione, administration of neuroleptic drugs, administration of cyclosporin A, asthma, alcohol withdrawal,. [0032] Accordingly, substantially optically pure enantiomeric forms of SAM-e salts of this invention are effective in preventing and/or treating the above conditions due to their ability to increase SAM-e levels. To this end, substantially optically pure enantiomeric forms of SAM-e salts of the present invention may be used for pharmaceutical, prophylactic and/or cosmetic purposes, and are administered to a warm-blooded animal in an effective amount to achieve a desired result. [0033] In the case of pharmaceutical administration, an effective amount is a quantity sufficient to treat the symptoms of a condition and/or the underlying condition itself An effective amount in the context of prophylactic administration means an amount sufficient to avoid or delay the onset of a condition and/or its symptoms. Lastly, an effective amount with regard to cosmetic administration is an amount sufficient to achieve the desired cosmetic result. [0034] In a preferred embodiment, the substantially optically pure enantiomeric forms of SAM-e salts of the present invention are administered to a warm-blooded animal as a pharmaceutical, prophylactic or cosmetic composition containing at least one substantially optically pure enantiomeric forms of SAM-e salt in combination with at least one pharmaceutically, prophylactically or cosmetically acceptable carrier or diluent. Administration may be accomplished by systemic or topical application, with the preferred mode dependent upon the type and location of the conditions to be treated. Frequency of administration may vary, and is typically accomplished by daily administration. [0035] Systemic administration may be achieved, for example, by injection (e.g., intramuscular, intravenous, subcutaneous or intradermal) or oral delivery of the composition to the warm-blooded animal. Suitable carriers and diluents for injection are known to those skilled in the art, and generally are in the form of an aqueous solution containing appropriate buffers and preservatives. Oral delivery is generally accomplished by formulating the composition in a liquid or solid form, such as a tablet or capsule, by known formulation techniques. [0036] Topical administration may be accomplished, for example, by formulating the composition as solution, cream, gel, ointment, powder, paste, gum or lozenge using techniques known to those skilled in the formulation field. As used herein, topical administration includes delivery of the composition to mucosal tissue of the mouth, nose and throat by, for example, spray or mist application, as well as to the vagina and rectum by, for example, suppository application. [0037] The following example illustrates the synthetic process by which the new enantiomeric SAM-e salts may be made. In addition, the example shows how these new SAM-e salts may be used clinically. This example is given to illustrate the present invention, but not by way of limitation. Accordingly, the scope of this invention should be determined not by the embodiment illustrated, but rather by the appended claims and their legal equivalents. EXAMPLE 1 [0038] 1. (S, S)-s-adenosylmethionine was prepared according to the method of Hoffman (Hoffman, Chromatographic Analysis of the Chiral and Covalent Instability of S-adenosyl-l-methionine, Biochemistry 1986, 25 4444-4449). Enantiomerically pure (S, S)-SAM-e was stabilized according to Fiecchi (U.S. Pat. No. 4,028,183, Jun. 7, 1977) using p-toluene sulfonate as the stabilizing agent. [0039] (S, S)-s-adenosylmethionine 400 mg was administered twice daily in an open, non-blind study of 10 volunteers who gave informed consent. All patients had normal results on pre-study medical examinations, including laboratory examinations. Patients received 400 mg of (S, S)-s-adenosylmethionine in an enteric-coated tablet form twice daily for 14 days or until remission of depression symptoms. The 10 patients satisfied the DSM-III criteria for a major depressive episode. Patients' symptoms were monitored daily using the Hamilton Rating Scale for Depression. 9 patients completed the study. (One patient declined to continue the study after beginning.) Eight of the nine patients who completed the trial improved over the 14 days. One patient had no change at all. No side effects were noted or reported by any of the patients nor as measured by laboratory or physical examination. (S, S)-s-adenosylmethionine 400 mg twice daily appeared to be safe and effective in this small, non-blinded study of depression.

1a

FIELD OF THE INVENTION The present invention relates to a novel therapeutic application of the fluoroquinolone derivatives of general formula: ##STR2## in which R 1 is an alkyl radical containing 1 to 4 carbon atoms or a fluoroethyl, cyclopropyl or difluorophenyl radical, R 2 , R 3 and R 4 are identical or different and represent hydrogen atoms or methyl radicals, X represents a nitrogen atom or a group ═CR 6 -- in which R 6 is a hydrogen or fluorine atom, or alternatively R 6 with the radical R 1 and the atoms to which they are attached forms a six-membered heterocycle substituted with a methyl radical and optionally containing an oxygen atom, and R 5 is a hydrogen atom, or can represent an amino radical if R 6 is a fluorine atom, as well as their salts. BACKGROUND OF THE INVENTION The fluoroquinolone derivatives which form the subject of the present invention are widely known for their antimicrobial activity: BE 870,576; U.S. Pat. No. 4,448,962, DE 3,142,854; EP 47,005; EP 206,283; BE 887,574; EP 221,463; EP 140,116; EP 131,839; EP 154,780; EP 78,362; EP 310,849. Pneumocystis carinii is a ubiquitous microorganism capable of infecting many mammals. In particular, in immunosuppressed humans, it is the source of severe hypoxaemia-inducing pneumonia, which is fatal in the absence of treatment. Pneumonia caused by Pneumocystis carinii occurs in subjects such as premature infants or those suffering from a severe chronic disease, and older children or adults suffering from cancer or from hematological malignancies (leukosis, Hodgkin's disease) subjected to prolonged corticoid therapy or to an immunosuppressive treatment. Pneumonia caused by Pneumocystis carinii is, in effect, the commonest opportunistic infection of AIDS and is responsible for a high mortality rate in patients suffering from this disease. DESCRIPTION OF THE INVENTION It has been found that the fluoroquinolones of general formula (I), as well as their salts, possess an especially advantageous anti-Pneumocystis activity, and are thus entirely suitable for the preparation of a medicinal product intended for the preventive and/or treating of pneumocystosis of man and/or of animals. Among the products of general formula (I), the products mentioned below are the preferred products: pefloxacin, enoxacin, norfloxacin, ofloxacin, ciprofloxacin, sparfloxacin, fleroxacin, lomefloxacin or temafloxacin. The activity was demonstrated by the following test: ACTIVITY AGAINST PNEUMOCYSTOSIS OF RATS First Series of Trials Rats weighing 200 to 250 g, immunosuppressed by two subcutaneous injections per week of hydrocortisone acetate (25 mg) and a protein-poor diet, are used. Some rats additionally receive doxycycline (10 mg) subcutaneously twice weekly, so as to prevent the occurrence of infections other than pneumocystosis. After two weeks of immunosuppression, the existence of a progressive pneumocystosis is verified by sacrificing some rats and counting the Pneumocystis present per gram of lung. The products tested for their anti-Pneumocystis activity are dissolved in isotonic phosphate buffer at the desired concentration. They are administered intraperitoneally for two weeks. Two groups of control animals are formed: 1/--immunosuppressed rats receiving doxycycline throughout the study period (four weeks), 2/--immunosuppressed rats receiving doxycycline only during the first two weeks of the study. Another group of immunosuppressed rats, receiving doxycycline during the first two weeks of the study, receives the combination trimethoprim (40 mg/kg)/sulphamethoxazole (200 mg/kg) subcutaneously twice weekly during the last two weeks of the study. Two groups of animals are treated with the product under study; they comprise immunosuppressed rats receiving doxycycline only during the first two weeks of the study, and then: 1/--the product under study (50 mg/kg) twice daily intraperitoneally during 14 days; 2/--the product under study (100 mg/kg) twice daily intraperitoneally during 14 days. At the end of the four weeks, all the rats are sacrificed, the lungs are removed and the Pneumocystis carinii are counted. RESULTS The results obtained appear in Table I below. At autopsy the lungs of the control animals of the 1st and 2nd groups were brownish-grey with broad oedematous areas. In contrast, those of the animals treated with the test product and with the trimethoprim/sulphamethoxazole combination (3rd control group) were pink and showed no pathological sign. The mean lung weights do not differ and are lower than those of the control animals. Number of Pneumocystis carinii: The control rats of groups 1 and 2 had a mean of 3.7×10 7 and 2.6×10 7 Pneumocystis per lung. The animals treated with the test product had a mean of 1.3×10 5 Pneumocystis (50 mg/kg) and 8.9×10 4 Pneumocystis (100 mg/kg), respectively, per lung. These values are very close to those obtained following treatment with the trimethoprim/sulphamethoxazole combination (2.4×10 4 Pneumocystis). CONCLUSION The treatment with 50 mg/kg is especially effective. SECOND SERIES OF TRIALS In another series of trials, the control group consists of immunosuppressed rats receiving doxycycline (10 mg) subcutaneously twice weekly throughout the trial period (4 weeks). Another group of immunosuppressed rats receives the combination trimethoprim (40 mg/kg)/suphamethoxazole (200 mg/kg) subcutaneously twice weekly from the start of immunosuppression. The products under study are administered orally to immunosuppressed rats on the basis of 100 mg/kg 3 times weekly. The action of pefloxacin, temafloxacin and ofloxacin is studied. After 4 weeks of immunosuppression, all the animals are sacrificed and the intrapulmonary Pneumocystis carinii are quantified. RESULTS The results obtained appear in Table II below. Pefloxacin, temafloxacin and ofloxacin administered orally produce a decrease in the number of Pneumocystis carinii. TABLE I__________________________________________________________________________ACTIVITY AGAINST MURINE PNEUMOCYSTOSIS Group receiving trimethoprim/ 1st control 2nd control Pefloxacin Pefloxacin sulphamethoxazole group + doxycyline group + doxycyline 50 mg/kg i.p. 100 mg/kg i.p. 40/200 mg/kg s.c. (4 weeks) (6 rats) (2 weeks) (4 rats) (5 rats) (5 rats) (5 rats)__________________________________________________________________________Initial 241 ± 17 238 ± 15 237 ± 12 238 ± 12 232 ± 8weight (g)Weight + 145 ± 16 147 ± 9 164 ± 6 163 ± 6 177 ± 104 weeksRats dead 3 0 0 2 1 (yeast)Rats sacrificed 3 4 5 3 4Lung 144 ± 0.31 1.36 ± 0.28 0.95 ± 0.04 0.86 ± 0.04 1.00 ± 0.15weight (g)Number of 3 × 10.sup.7 ± 1.7 × 10.sup.7 1.7 × 10.sup.7 ± 2.4 × 10.sup.7 1.4 × 10.sup.5 ± 1 × 10.sup.5 9.8 × 10.sup.4 ± 12 × 10.sup.4 2.3 × 10.sup.4 ± 2.9 × 10.sup.4Pneumocystis/gof lungNumber of 3.7 × 10.sup.7 ± 2.1 × 10.sup.7 2.6 × 10.sup.7 ± 2.8 × 10.sup.7 1.3 × 10.sup.5 ± 1 × 10.sup.5 8.9 × 10.sup.4 ± 10 × 10.sup.4 2.4 × 10.sup.4 ± 2.8 × 10.sup.4Pneumocystisper lung__________________________________________________________________________ After the first two weeks of immunosuppression, 3 rats were sacrificed: Number of Pneumocystis = 2 × 10.sup.6 /g of lung. TABLE II__________________________________________________________________________ACTIVITY AGAINST MURINE PNEUMOCYSTOSIS Group receiving trimethoprim/ Control group + Pefloxacin Temafloxacin Ofloxacin sulphamethoxazole. doxycyline 100 mg/kg p.o. 100 mg/kg p.o. 100 mg/kg p.o. 40/200 mg/kg s.c. (4 weeks) (15 rats) (5 rats) (5 rats) (5 rats) (10__________________________________________________________________________ rats)Initial 223 ± 18 237 ± 13 210 ± 6 236 ± 9 237 ± 14weight (g)Weight + 164 ± 22 183 ± 18 160 ± 12 205 ± 25 178 ± 114 weeksRats dead 2 0 0 0 1Rats sacrificed 13 5 5 5 9Number of 4.8 × 10.sup.6 8.0 × 10.sup.3 6.1 × 10.sup.5 7.9 × 10.sup.5 2.0 × 10.sup.3Pneumocystis/g 2.1 × 10.sup.6 - 1.1 × 10.sup.7 3.0 × 10.sup.2 - 2.1 × 10.sup.5 2.1 × 10.sup.5 - 1.8 1.4 × 10.sup.5 - 4.4 × 10.sup.6 1.0 × 10.sup.3 - 3.3 × 10.sup.3of lung__________________________________________________________________________ The present invention relates to the production of a medicinal product containing at least one product of general formula (I), optionally in salt form, in the pure state or in the form of a pharmaceutical composition in combination with one or more compatible diluents or adjuvants. These compositions may be used orally, parenterally or as aerosols. The compositions may be used for the purposes of cure or of prevention in subjects exhibiting an immunodeficiency and/or infected with Pneumocystis carinii and/or possessing a risk of contamination with Pneumocystis carinii. Naturally, the constitution of these compositions will be adapted to the particular case of the digestive tract of the immunosuppressed subjects. As solid compositions for oral administration, tablets, pills, hard gelatin capsules, powders or granules may be used. In these compositions, the active product according to the invention is mixed with one or more inert diluents or adjuvants such as sucrose, lactose or starch. These compositions may comprise substances other than diluents, e.g. a lubricant such as magnesium stearate. As liquid compositions for oral administration, solutions which are pharmaceutically acceptable, suspensions, emulsions, syrups and elixirs containing inert diluents such as water or liquid paraffin may be used. These compositions may also comprise substances other than diluents, e.g. wetting, sweetening or flavoring products. The compositions for parenteral administration can be sterile solutions, aqueous or non-aqueous, suspensions or emulsions. As a solvent or vehicle, propylene glycol, a polyethylene glycol, vegetable oils, especially olive oil, and injectable organic esters, e.g. ethyl oleate, may be employed. These compositions can also contain adjuvants, especially wetting, tonicity, emulsifying, dispersant and stabilizing agents. The sterilization may be carried out in several ways, e.g. using a bacteriological filter, by irradiation or by heating. They may also be prepared in the form of sterile solid compositions which can be dissolved at the time of use in sterile water or any other sterile injectable medium. The compositions intended for use in the form of liquid aerosols can be stable sterile solutions or solid compositions dissolved at the time of use in pyrogen-free sterile water, saline or any other pharmaceutically acceptable vehicle. The aerosols can also be dry aerosols intended for direct inhalation, in which the finely divided active principle is combined with a water-soluble solid diluent or vehicle having a particle size of 30 to 80 microns, such as, e.g., dextran, mannitol or lactose. In human therapy, the doctor will determine the dosage he considers most suitable in accordance with a preventive or curative treatment, in accordance with the age, weight, degree of infection and other factors specific to the subject to be treated. In general, the doses are between 1 and 5 g per day orally for an adult. The examples which follow illustrate compositions according to the invention intended for the treatment of pneumocystosis: EXAMPLE A Tablets are prepared containing a 400-mg dose and having the following composition: Pefloxacin in the form of a mesylate dihydrate: 400 mg Excipient: core: wheat starch, gelatin, talc, magnesium stearate, sodium carboxymethylstarch q.s. one core; coating: hydroxypropylmethylcellulose, ethylcellulose, dibutyl sebacate, titanium oxide, talc, polyoxyethylene glycol 6,000. EXAMPLE B Tablets are prepared containing an 800-mg dose and having the following composition: Pefloxacin in the form of a mesylate dihydrate: 800 mg Excipient: core: wheat starch, gelatin, talc, magnesium stearate, sodium carboxymethylstarch q.s. one core; coating: hydroxypropylmethylcellulose, ethylcellulose, dibutyl sebacate, titanium oxide, talc, polyoxyethylene glycol 6,000. The present invention also relates to compositions for preventive or curative veterinary use against pneumocystosis: The compositions for veterinary use may be used in the various injectable dosage forms described above for administration in man. They can also be animal feeds or concentrated mixtures intended for animal feeding, containing a sufficient quantity of the derivative of general formula (I). More specifically, they can take the form of water-soluble powders to be mixed with the feed. Generally speaking, the dosage to be employed will be that which is most suitable in accordance with the animal's weight, the degree of injection and other specific factors which may be involved, it being understood that the appropriate dose for producing an effect can vary within fairly wide limits. Although the invention has been described in conjunction with specific embodiments, it is evident that many alternatives and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, the invention is intended to embrace all of the alternatives and variations that fall within the spirit and scope of the appended claims. The above references are hereby incorporated by reference.

1a

BACKGROUND OF THE INVENTION [0001] The invention relates to a phase and sedimentation-stable, plastically deformable preparation (implant material/bone replacement material) with intrinsic pore formation, that can be used for instance for filling bone defects and for augmentation, and also relates to a method for producing same. [0002] Resorbable and non-resorbable implant materials based on calcium phosphates have been known for some time as bone replacement materials for filling bone defects and for augmentation. In addition to shaped bodies and granulates, in particular injectable and kneadable implant materials are of interest. [0003] One method and composition for repairing bones is disclosed in WO 03/063686. The composition is a hydrogel that is formed from hyaluronic acid and that is mixed with animal bone components, bone-like powder, or hydroxyapatite. Likewise, a growth inducing peptide can be a component of the mixture. [0004] A malleable bone composition for filling bone defects is described in EP 1 477 176 A1. This composition can be embodied as a paste or flowable gel and can comprise inter alia bone powder in a hydrogel carrier. In accordance with EP 1 477 176 A1, the powder component can comprise 25 to 35% of the material and can have a particle size of 100-850 μm. The hydrogel carrier can comprise chitosan having a molecular weight of 100,000-300,000 Daltons and comprising 1-4.5% of the material. [0005] Known from U.S. Pat. No. 5,258,028 are injectable microimplants that comprise a hydrogel made of polyvinylpyrrolidone and a plastic material made of polydimethylsiloxane. Alternative to this polymer, particles made of calcium salts, such as hydroxyapatite, biocompatible ceramics, or biocompatible metals can also be used. The size of the biologically compatible particles can be between 10 and 3000 micrometers. [0006] U.S. Pat. No. 4,710,76 discloses a coating composition that comprises highly porous spherical particles and a resorbable binder. The particles comprise tricalcium phosphate and the binder comprises gelatins, polyamino acids, or collagen. [0007] U.S. Pat. No. 4,780,450 suggests a composition for bone treatment, the composition containing polycrystalline, particulate calcium phosphate ceramic, acid, phosphorous-containing proteins, and type I collagen. In U.S. Pat. No. 4,780,450, hydroxyapatite, β-tricalcium phosphate ceramic, or mixtures thereof are listed as calcium phosphate ceramics. [0008] EP 0416 398 A1 also describes paste-like bone replacement material, the materials being formed from an aqueous solution of pullulan, glycol chitin, carboxymethyl chitin and pectin, in which solution calcium phosphate particles are suspended. Hydroxyapatite, fluorapatite, α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium phosphate are used as calcium phosphates. [0009] US 2002/169506 also describes kneadable fill materials, these materials comprising calcium phosphate granulate and so-called “small chips”. These chips are formed from chitin and after contact with water are intended to bind the granules of the calcium phosphate granulate in that they stick together. [0010] WO 03/082365 describes a kneadable and pliable bone replacement mass that comprises a mixture of calcium-containing ceramic particles and a hydrogel or a substance that can swell to form a hydrogel, the ceramic particles being of entirely synthetic origin and the majority of the ceramic particles not being round in shape. The individual ceramic particles have an at least partially cohesive, porous structure. The calcium-containing ceramic particles can comprise dicalcium phosphate dihydrate, dicalcium phosphate, α-TCP, β-TCP, wherein “TCP” means tricalcium phosphate, calcium-deficient hydroxyapatite, hydroxyapatite, carbonate apatite, chlorapatite, whitlockite, tetracalcium phosphate, oxyapatite, calcium pyrophosphate, and octacalcium phosphate. The substances that can swell to form hydrogels can contain polyamino acids, polysaccharides, polylipids, nucleotides, or combinations thereof as components. [0011] Patent application US 2003/055512 discloses an injectable, bioresorbable bone replacement material based on calcium. The material is a mixture of calcium sulfate and a phosphate cement powder that hardens after mixing with water. [0012] A paste for treating bones is known from WO 2004/011053. This paste comprises a carrier gel based on hyaluronic acid and synthetic hydroxyapatite suspended therein or comprises hydroxyapatite prepared from bone material. [0013] “Bioresorbable composite bone paste using polysaccharide based nano hydroxyapatite” (R. Murugan, S. Ramakrishna, Biomaterials 2004, 25 3829-3835) describes a paste having nanoparticulate, precipitated hydroxyapatite. Sols made of chitosan, a polysaccharide, are used for binders and matrix for the hydroxyapatite particles. [0014] FR 28 52 249 discloses a bone filling material, especially for use in conjunction with oral implants, comprising a source of phosphate and calcium and a stimulant for stimulating collagen production using osteoblasts, for instance in the form of hydroxyproline-mono or di-palmitate. Cited as calcium phosphate sources are hydroxyapatite, dicalcium phosphate, α-tricalcium phosphate, β-tricalcium phosphate, tetracalcium phosphate, and octacalcium phosphate, which are intended to stimulate collagen formation. The composition can be produced in different forms, inter alia having a viscosity that permits application in a syringe. [0015] The viscosity of the composition is set by means of cohesion promoters that belong to the group of celluloses, amidones, cyclodextrines, alginates, dextransul fates, polyvinylpyrrolidones, or hyaluronic acid. The grain size of the calcium phosphate is less than 100 μm and can be 50, 20, 10, or 5 μm. Combination with platelet rich plasma (PRP) and other growth factors is possible. [0016] WO 03/035124 describes bioactive materials and methods for producing and using same. Disclosed in this publication inter alia is a bioactive composition made of a fibroin suspension and optionally a pore-forming, particulate material. The fibroin suspension can have the form of an occlusion, a gel, a crème, or a paste. The fibroin can derive from the fiber substance of silk threads from the Bombyx mori silkworm. The pore-forming, particulate material can be hydroxyapatite, tricalcium phosphate, Korelle, chitosan, or a combination of these materials. Furthermore, the pore-forming, particulate materials can be a composite in which the core can comprise calcium phosphates or glass ceramics and the surrounding shell can comprise one or a plurality of biodegradable polymers such as polylactide, polyglycolide, poly-alpha-hydroxy acids, polyamides, etc. [0017] Known from WO 03/028779 is an injectable osseous defect filler comprising calcium salt particles, an organic binder having an affinity to the calcium salt, cells from the group of stem cells, osteogenic cells, and osteoprogenitor cells, and a pharmaceutically acceptable buffer. In this osseous filler, calcium phosphate particles, such as for instance monetite (CaHPO 4 ), brushite (CaHPO 4 *2H 2 O), calcium pyrophosphate, and also calcium carbonate and combinations thereof are used as calcium salts. The calcium salts can also comprise hydroxyapatite and β-TCP or mixtures thereof. The particle diameter of the calcium salts is in the range of 100 to 600 μm, preferably in the range of 200 to 400 μm. Alginates, dextrans, celluloses and their derivatives, plasma, biogenic binders, hyaluronic acid and combinations thereof are cited as organic binders. Hyaluronic acid, sodium alginate, sodium carboxymethyl cellulose, dextran, fibrin glue, and transglutaminase are preferred. WO 03/028779 states that the best effects are obtained with sodium alginate. In accordance with this publication, the quantities of binder are in the range of 0.5 to 10% by weight, preferably in the range of 3 to 7% by weight. A phosphate buffer (PBS) is used for the buffer. The solid content is in the range of 30 to 70, preferably in the range of 40 to 60% by weight. According to WO 03/028779, pastes having a viscosity of 30,000 to 100,000 centipoise can be easily injected. The needles used have a diameter of 2 to 5 mm and a length of 5 to 20 mm. The information regarding the force necessary for injection is provided as a function of different parameters. Additional growth factors may be present in addition to the cells that colonize on the surface of the calcium phosphate particles. [0018] Known from WO 02/058755 is an injectable porous bone replacement material that can increase its porosity in situ. This material comprises a bone-like compound and a hydrophobic carrier. The bone-like compound can comprise calcium phosphates, potassium phosphate, calcium sulfate, hydroxyapatite, bioactive glasses, and combinations thereof. The hydrophobic substances can comprise proteins, glycoproteins, polyesters, polyanhydrides, polyamines, wax-like biodegradable polymers such as polyglycolid and combinations thereof. [0019] Moreover, in accordance with WO 02/058755, aqueous components and mixtures of a degradable component and the aforesaid bone-like substances can be used. The biodegradable components can comprise polyhydroxypolyesters, albumin, collagen, proteins, polysaccharides, glycoproteins, and combinations thereof. A gas forming component, for instance hydrogen peroxide and/or peroxidase, is suggested for producing porosity. [0020] WO 01/41821 describes an injectable, self-setting mixture that enables formation of hardened biomaterials with broad variations in properties. This mixture comprises a water-based liquid component, at least one cationic polymer, and a monophosphate salt having a pH in the range of 6.5 to 7.4. According to WO 01/41821, the aqueous phase has endothermal gel-forming properties. The second component of the mixture comprises at least two calcium phosphates made of apatites, octacalcium phosphates, amorphous calcium phosphates, tetracalcium phosphates, tricalcium phosphates, dicalcium phosphates, and monocalcium phosphates. The cationic polymer is contained in the first component at 0.1-5.0% by weight and can comprise polysaccharides, polypeptides or synthetic polymers, chitin, or chitosan. The monophosphate salt can constitute sodium potassium phosphates, magnesium phosphates, manganese phosphates, or iron phosphates with different stoichiometry. Mentioned as water-soluble polymers are various modified celluloses, polyethylene glycol, polyvinyl alcohol, organic polyols, glycol oligomers, sugar, and glycerol. The mixture can furthermore contain growth factors. [0021] EP 1 475 109 A1 discloses a formulation for injectable application of osteogenic proteins comprising a pharmaceutically acceptable admixture of the osteogenic protein and a hemostatic gelatin foam paste. This formulation can also contain tricalcium phosphate. The osteogenic proteins can derive from the BMP (bone morphogenetic protein) family, preferably BMP-2 and OP-1. The TCP (tricalcium phosphate) particles are microporous and have a particle size of 45-125 μm, which can be injected through an 18-gauge needle (equivalent of 1.2 mm diameter and 40 mm length). Moreover, this publication also describes alginates or celluloses as agents for controlled release of the proteins. [0022] Known from WO 01/41824 is a hydraulic brushite cement that is stabilized with magnesium salts. The brushite cement can be produced from an basic calcium phosphate, a second component comprising an acid calcium phosphate, a third component comprising water, and a fourth component, for controlling the setting reaction, comprising a magnesium salt. In accordance with WO 01/41824, the basic calcium phosphates can derive from the class of tricalcium phosphates and apatites. The acid phosphate components can comprise monocalcium phosphates. The fourth component, contained as from 0.001 to 60% by weight, can derive from various magnesium phosphates and magnesium salts of organic compounds. [0023] The liquid components can also contain sulfuric acid or phosphoric acid. In accordance with WO 01/41824, additives can be used for controlling the flow properties of the cements. These can comprise polysaccharides, preferably hyaluronic acid and its salts, dextran, alginate, hydroxypropylmethyl cellulose, chitosan, or xanthan. The cement can contain granules with diameters ranging from 100 μm to 500 μm, preferably ranging from 200 to 350 μm. The granules can comprise calcium phosphate or gypsum. The set cement mixture can have a Ca:P ratio of 1.00 to 1.67. [0024] WO 00/07639 discloses bone precursor compositions and methods for producing same. These compositions can contain injectable calcium cements made of monocalcium phosphate monohydrate and β-TCP (“TCP” meaning tricalcium phosphate) and also calcium pyrophosphate and calcium sulfate. These calcium cements can have granular shapes ranging from 1 to 500 μm. Collagens, methylcellulose, biopolymers, or other pharmaceutically acceptable substances may be contained for controlling viscosity. In addition, CAPS, triethanolamine, TES, tricine, HEPES, glycine, PBS, bis tris propane, TAPS, AMP, and TRIS can be used to neutralize the pH of the bone precursor substance. [0025] WO 00/45867 discloses a hydraulic cement having a calcium source, water, and a hydrophobic liquid. This mixture constitutes a calcium source and water, which when mixed with one another results in a self-hardening cement paste. A third component comprises a hydrophobic liquid that, washed out in situ, results in a cement having an open macroporosity that permits rapid bone ingrowth. The hydrophobic liquid can derive from the group of fats or oils. The calcium source can derive from the class of calcium phosphates. The Ca:P ratio for the calcium source can be between 1.0 and 1.67. In this regard, the publication cites inter alia monocalcium phosphate monohydrate and anhydrous monocalcium phosphate, dicalcium phosphate, octacalcium phosphate, alpha and beta tricalcium phosphate, tetracalcium phosphate, hydroxyapatite. Polymer additives can be used as additives for controlling the flow properties of the cement. These additives can derive from the group of polysaccharides and can include for instance modified celluloses such as hydroxypropylmethyl cellulose, hydroxyethyl cellulose, and hyaluronic acid. Moreover, an emulsifying agent from the group of surfactants can be used as a stabilizer. Pharmaceutically and physiologically active substances can be added in. [0026] Known from WO 95/21634 is a biomaterial composition and a method for producing same. The composition can contain 40 to 75% by weight β-tricalcium phosphate and hydroxyapatite in a ratio of from 20:80 to 70:30, as well as calcium titanium phosphate (CaTi 4 (PO 4 ) 6 ) and 60 to 25% by weight of a liquid phase, comprising an aqueous solution of a cellulose derivative. Furthermore, the publication also mentions hydroxypropyl methylcellulose. [0027] The size of the granules is 80 to 200 μm. The material is sterile, ready for use, and injectable. SUMMARY OF THE INVENTION [0028] The disadvantage of many of the aforementioned known mixtures is that they are not homogenous or stabile over an extended period of time. In addition, there is the fact that some mixtures cannot be applied using cannulas because of their nature. In terms of the compositions from the prior art that contain calcium phosphate, there is the problem that over an extended period of time a relatively solid calcium phosphate phase that cannot be kneaded settles out under an aqueous phase, which is particularly disadvantageous for the commercial viability of pre-manufactured mixtures. [0029] The present invention is intended to eliminate the aforesaid deficiencies of the prior art in a simple manner and to provide a phase and sedimentation-stable, plastically deformable implant material with intrinsic pore formation that has a viscous to paste-like consistency, that is not complex to create, and that can be inserted into a bone defect by injection or alternatively can be applied to/fitted in a bone defect as a kneadable mass. It is furthermore the object of the invention to provide a method for producing this material. [0030] The essence of the invention is comprised in that particles are used that have a diameter in a range that is greater than a phagocytable particle (in section 2 “Particle Size and Mechanical Properties”, F. Peters, D. Reif publication “Functional Materials for Bone Regeneration from Beta-Tricalcium Phosphate”, Mat.-wiss. u. Werkstoffiech. 2004, 35 (4), 203-207, states that for biomaterials made of beta-tricalcium phosphate the mean particle size should be in the range of 7-10 μm in order to prevent the phenomenon of phagocytosis) and that is matched to the passage diameter of common injection cannulas and these particles are mixed intimately with a binder substances, stabilizing substances that suppress sedimentation being added simultaneously. The binder substances are organic in nature and can be from the group of alginates, starches, polysaccharides, celluloses, modified celluloses, hyaluronic acids and their salts, gelatins, collagens, polyacrylic acids, aqueous or alcoholic solutions thereof, dextrans, polyethylene glycols, or mixtures thereof. [0031] In accordance with the present invention, it is possible to produce stable, flowable suspensions using anhydrous mixtures of liquid polyethylene glycols and calcium phosphate particles. Likewise, in accordance with the invention, stable suspensions can be produced with aqueous solutions of the aforesaid polysaccharides, alginates, starches, modified celluloses, proteins, and protein mixtures. [0032] Sliding of the ceramic particles relative to one another is effected using the inventive addition of cohesion promoters, particularly advantageously hydrogels, to the composition. At the same time, the inventively added cohesion promoters prevent individual components in the composition from settling (sedimentation) so that the composition is maintained as a homogenous suspension over an extended period of time. [0033] In a bone defect to be filled, the easily soluble hydrogel component acts as an intrinsic pore former. The intermediate spaces between the particles, whose size is a function of particle size and particle size distribution, promote ingrowth of veins and tissue. The more easily soluble hydrogel matrix additionally expands the agglomeration of the particles and at the same acts as a cohesion promoter for insuring injectability. The hydrogel matrix is disposed between the particles. When inserted into the defect, blood coagulates calcium-indicated on the surface of the particle material. The more easily soluble hydrogel component is resorbed within a short period of time; agglomeration of the particles stabilized by the fibrous tissue remains behind. This agglomeration is made of resorbable bioceramic with large interparticulate intermediate spaces now satisfies all of the requirements for a bone replacement material in terms of porosity, freedom from phase shift, and resorbability. The following is understood for the term “not easily soluble”. The “not easily soluble” substance dissolves in water at room temperature in a maximum concentration of 100 mg/L. [0034] The inventive addition of substances that are phase-pure (i.e., consisting of a single phase), in particular phase-pure beta-tricalcium phosphate, to the composition effects greater structural stability because no materials having different coefficients of thermal expansion or different solubility cause premature particulate disintegration [0035] The inventive composition has particles that have interconnecting pores (micropores ≦0.01-50 μm) so that cells can be fed in vivo, even within the composition/biomaterial. In addition, the liquids (for instance blood or body fluid) dissolve a resorbable/degradable biomaterial (such as for instance beta-tricalcium phosphate) from the inside to the outside so that prompt resorption can accompany bone growth. Due to the interconnecting microporosity of the biomaterial, capillary forces also cause a tamponade-like effect in feeding the defect. Macropores (>50 μm) promote vascularization and provide guides for the growth of newly-formed bone. Pore diameters in the range of 50-100 μm demonstrated good results. Long and winding pores cannot be completely filled with bone if there is no contact with the supply media. Therefore it is necessary to design the large pores so that they are interconnected by small pores. For large blocks of biomaterial, this porosity is attained by adding pore-formers, foaming, or drilling. With granules, the intergranular intermediate spaces satisfy the function of macropores. [0036] Moreover, due to pores being added and due to small particles there is a lower quantity of material per defect volume acting as placeholder in the bone defect. Increased resorption speed results from the lower quantity of material and from the large surface area for smaller particles. The stability of the open structure is optimized by the inventive solution in that no premature decomposition into phagocytable subparticles occurs during the resorption. [0037] It is inventive that porous particles in the size range of 0.1-150 μm, with pore diameters of 0.01-50 μm, can comprise β-tricalcium phosphate, α-tricalcium phosphate, whitlockite, tetracalcium phosphate, octacalcium phosphate, hydroxyapatite, type A carbonate apatite, type B carbonate apatite, calcium-deficient hydroxyapatite, amorphous calcium phosphate, and/or resorbable glass ceramics. The particles can have both a round shape and a polygonally broken shape that is rounded by wear and thermal sintering. [0038] The plastically deformable implant material having particles embodied in this manner can be paste-like or can have a very highly viscous, more kneadable to wax-like form. The paste-like form of the implant material is embodied such that it can be applied to the bone defect in a minimally invasive manner by means of an injection syringe having a straight or angled cannula. The diameters of the particles are optimized for the cannula diameter of an injection cannula. Particle diameters are optimized such that the paste-like material can also be applied using a cannula that is angled up to 60°, measured with respect to the longitudinal axis of the injection syringe. [0039] The inventive particles are not easily soluble in water, are biologically active, and have a polygonally broken rounded shape. This shape attains optimum cohesion of the structural agglomeration of the particles. [0040] It is essential for the invention that it is constructed from a mixture of 60-98% by mass calcium phosphate particles and 1-30% by mass of an aqueous or alcoholic solution of dextran and/or carboxymethyl dextran and/or hyaluronic acid and/or dermatan sulfate, carboxymethyl cellulose and/or oxidized cellulose and/or gelatins and/or mixtures thereof. The use of polysaccharide derivatives, such as for instance carboxymethyl dextran, carboxymethyl hyaluronic acid, and sulfated hyaluronic acid, is also within the sense of the invention. The particular advantage of using hydrophobically modified calcium phosphate particles is that in particular anionic polysaccharides and polysaccharide derivatives, such as hyaluronic acid or carboxymethol dextran, can interact, via their carboxyl groups, with the calcium phosphate surfaces in only a limited manner. This has a positive effect on rheological properties. It is likewise inventive that it is preferably constructed from a mixture of 80-98% by mass calcium phosphate particles, 1-20% by mass anhydrous polyethylene glycol 400, and 1-20% by mass anhydrous polyethylene glycol 600. Polyethylene glycol 400 and polyethylene glycol 600 can also contain oxidation stabilizers, in addition. [0041] The plastically deformable preparation for bone construction/replacement based on ceramic suspensions is inventively in a paste form so that it can be applied using an injection cannula. [0042] The particle shape and particle size of the particulate component that is not easily soluble in water are matched to the diameter of the injection cannula. [0043] The mean particle diameter of the biologically active substance is inventively optimized such that the mixture can be applied using an angled cannula, the angle being up to 60°, preferably 45°, measured with respect to the longitudinal axis of the injection syringe. [0044] The particle size of the ceramic particle to be injected has an upper limit (tilt of the particles just prior to and in the cannula), but it is also limited in terms of the smallest diameter: from various works it is known that large quantities of particles in the range of less than 5 μm-diameter can lead to an excessive reaction to foreign bodies. The particles are absorbed and transported away or metabolized (phagocytosis) by macrophages (large foreign-body-eating cells). This is addressed inter alia in the following publications: S. Shimizu in Biomed. Res. 1988, 9 (2), 95 and J. van der Meulen and H. K. Koerten in J. Biomed. Mater. Res. 1994, 28, 1455. The consequence can be aseptic excessive reactions to foreign bodies that can trigger inflammation of the surrounding soft tissue. The reduction in pH in the vicinity of the phagocyting macrophages (center of inflammation) leads to the decomposition of additional ceramic into small subparticles that are also phagocyted. Soft tissue can grow into the resultant gaps and thus interfere with successfully correcting the defect. [0045] Therefore, the majority of invention-essential mean particle diameters are larger than the phagocytable size. [0046] The invention-essential mean particle diameters d 10 , d 50 , and d 90 of the biologically active substance/particles behave as follows for cannula diameter k: [0000] K≧ 3/20 *d 10 +1/2 , k≧ 2/25 *d 50 , and k≧ 2/25 *d 90 +4/5. [0047] In addition to particle size, the particle shape also has a characteristic property that is essential to the invention. For attaining a polygonally-broken shape, larger units of the ceramic powder are pressed, sintered (burned), and broken. The broken particles are subjected to a thermal sintering step so that they have a rounded sintered structure. Thus no sharp-edged areas that could lead to irritation of the surrounding soft tissue after implantation can be detected on the particle surface. [0048] The inventive preparation can be in a kneadable form and thus can be more simple to apply and adapt. [0049] When in paste form, the inventive preparation/mixture can be applied using an injection cannula, the mixture having 60-80% by weight, preferably 67-75% by weight β-tricalcium phosphate, 17-37% by weight, preferably 25-35% by weight water, and 0.3-3% by weight, preferably 0.5-1.5% by weight low-viscosity methylcellulose. [0050] A kneadable wax-like inventive preparation can also comprise a mixture of 65-85% by weight, preferably 68-78% by weight β-tricalcium phosphate, 13-32% by weight, preferably 20-30% by weight water, and 0.1-3% by weight, preferably 0.3-1.0% by weight high-viscosity methylcellulose. [0051] Another paste-like form of the inventive preparation that can be applied using an injection cannula can comprise a mixture of 60-80% by weight, preferably 68-76% by weight β-tricalcium phosphate, 15-35% by weight, preferably 25-31% by weight water, and 0.1-3% by weight, preferably 0.2-0.9% by weight low-viscosity methylcellulose, and 0.01-2% by weight, preferably 0.1-0.6% by weight sodium hyaluronate or hyaluronic acid. [0052] One kneadable form of the inventive preparation can comprise a mixture of 60-80% by weight, preferably 65-78% by weight β tricalcium phosphate, 20-35% by weight, preferably 24-30% by weight water, and 0.05-3% by weight, preferably 0.1-0.7% by weight high-viscosity methylcellulose, and 0.05-2% by weight, preferably 0.1-0.5% by weight sodium hyaluronate or hyaluronic acid. [0053] Particularly advantageous is a preparation in the form of a mixture of made of 20-98% by mass calcium phosphate particles, 1-20% by mass anhydrous polyethylene glycol 400, and 1-20% by mass anhydrous polyethylene glycol 600. Moreover, the combinations HS+methocel+dextran; HS+methocel+PEG or HS+methocel+PEG+dextran are particularly advantageous. [0054] The density of the inventive preparation is between 1.3 g/cm 3 and 2.1 g/cm 3 , preferably between 1.6 g/cm 3 and 1.9 g/cm 3 , the water soluble organic binder substance with the particulate biologically active substance forming a porous agglomeration that is dimensionally stable when applied, the easily soluble component in the defect environment being exchanged for fibrous tissue and the porous particle packing thus remaining dimensionally stable and being slowly integrated, vascularized, and resorbed. [0055] It is particularly advantageous when the water-soluble organic binder substance is provided such that it prevents settling of the particulate, biologically active substance in two phases, specifically a dense phase that primarily comprises the particulate substance and an aqueous phase. [0056] It is furthermore particularly advantageous when the hydrogel-forming components that are soluble in water or alcoholic solvents derive from substances from the group of alginates, starches, polysaccharides, celluloses, modified celluloses, hyaluronic acids and their salts, gelatins, collagens, shellac, polyacrylic acids, aqueous or alcoholic solutions thereof, dextranes, polyethylene glycols and their mixtures, and the biologically active substance comprises calcium phosphates and/or sodium-containing and/or potassium-containing and/or calcium-containing and/or silicate-containing acid and/or neutral and/or alkaline bioglasses or mixtures of the aforesaid. [0057] The biologically active substance also particularly advantageously comprises monocalcium phosphate-monohydrate, anhydrous monocalcium phosphate, dicalcium phosphate-dihydrate, anhydrous dicalcium phosphate, β-tricalcium phosphate, α-tricalcium phosphate, tetracalcium phosphate, whitlockite, octacalcium phosphate, hydroxyapatite, oxyapatite, type A carbonate apatite, type B carbonate apatite, calcium-deficient hydroxyapatite, amorphous calcium phosphate, amorphous carbonate-containing calcium phosphate, or mixtures of the aforesaid. The advantage of the inventive paste-like, kneadable, injectable compositions is that the hydrogel forming components that are soluble in water or alcoholic solvents have a property that inhibits crystallization so that recrystallization of the calcium phosphate system or the other possible ceramic components into a different phase by water is suppressed by this stabilizing component. [0058] Moreover, the preparation can contain growth-inducing proteins and thus can effectively promote bone and tissue regeneration. These growth factors can derive from the family of growth factors (GF) or from the bone morphogenetic proteins. Growth factors used are BMP-1 through BMP-12, particularly advantageously BMP-2 and BMP-7, and/or FGF, TGF-β, PDGF, VEGF, IGF, HGF, PTH, and/or mixtures thereof. [0059] Moreover, growth factor mixtures obtained directly from the patient's blood, such as e.g. platelet rich plasma (PRP), can also be contained in the preparation. [0060] The invention is explained in the following using the figures and exemplary embodiments. BRIEF DESCRIPTION OF THE DRAWINGS [0061] FIG. 1 is an embodiment of the inventive preparation in the form of a particle embedded in a hydrogel matrix; [0062] FIG. 2 is the embodiment in accordance with FIG. 1 with coagulated blood on the surface and pores resulting from the released hydrogel matrix; [0063] FIG. 3 is a graphic depiction of the measurement results in terms of phase stability of the embodiment of the inventive preparation in accordance with FIG. 1 ; [0064] FIG. 4 is another graphic depiction of the measurement results (x-ray powder diffractograms) for the conversion or recrystallization stability of the embodiment of the inventive preparation in accordance with FIG. 1 in various carrying media; [0065] FIG. 5 is a graphic depiction of a mercury pressure porosimetry measurement for determining the pore distribution in the particulate component of the embodiment of the inventive preparation in accordance with FIG. 1 , which component is difficult to dissolve. DETAILED DESCRIPTION OF THE INVENTION [0066] The inventive preparation based on calcium phosphate suspensions includes: a) a particulate component that is difficult to dissolve in water, and, b) at least one liquid or gel component that is soluble in water, so that a paste-like mixture is formed. [0069] The hydrogel component that dissolves more easily acts as an intrinsic pore former in the bone defect. [0070] The intermediate spaces between the particles of the preparation, the size of which is a function of the particle size and the particle size distribution, promote the ingrowth of veins and tissue. [0071] The hydrogel matrix that dissolves more easily also expands the agglomeration of the particles and simultaneously promotes cohesion in order to assure injectability. [0072] As FIG. 1 depicts, the hydrogel matrix ( 1 ) is located between the particles ( 2 ). [0073] When the inventive preparation is inserted into the defect, blood ( 3 ) coagulates, calcium-indicated, on the surface of the agglomeration of the particles, which is depicted schematically in FIG. 2 . [0074] The hydrogel component that dissolves more easily is resorbed within a short period of time so that the particle agglomeration stabilized by fibrous tissue remains. This agglomeration made of resorbable bioceramic having large interparticulate intermediate spaces now satisfies all requirements for a bone replacement material in terms of porosity, freedom from phase shift, and resorbability. [0075] The following is understood for the term not easily soluble. The not easily soluble substance dissolves in water at room temperature in a maximum concentration of 100 mg/L. [0076] In accordance with the invention, the particles in the preparation have a size in the range from 0.1 to 150 μm, pores having a diameter of 0.01-50 μm, and can comprise β-tricalcium phosphate, α-tricalcium phosphate, whitlockite, octacalcium phosphate, hydroxyapatite, type A carbonate apatite, type B carbonate apatite, calcium-deficient hydroxyapatite, amorphous calcium phosphate, and/or resorbable glass ceramics. [0077] The calcium phosphate particles can have both a round shape and a polygonally broken shape that is rounded by wear and thermal sintering. [0078] The aforesaid particles in the size range of 0.1 to 150 μm have pore diameters of 0.01 to 50 μm. [0079] The inventive, plastically deformable preparation can be paste-like or can have a very viscous, more kneadable to wax-like form. [0080] The paste-like form of the preparation is designed such that it can be applied to a bone defect in a minimally invasive manner by means of an injection syringe having a straight or angled cannula. [0081] The diameters of the particles are optimized for the cannula diameter of an injection cannula. Particle diameters are optimized such that the paste-like material can also be applied using an cannula that is angled up to 60°, measured with respect to the longitudinal axis of the injection syringe. [0082] It is essential for the invention that it is constructed from a mixture of 60-90% by mass calcium phosphate particles and 1-30% by mass of an aqueous or alcoholic solution of dextran and/or carboxymethyl dextran and/or hyaluronic acid and/or dermatan sulfate, carboxymethyl cellulose and/or oxidized cellulose and/or gelatins and/or mixtures thereof. The use of polysaccharide derivatives, such as for instance carboxymethyl dextran, carboxymethyl hyaluronic acid, and sulfated hyaluronic acid, is also within the sense of the invention. [0083] It is likewise inventive that it is preferably constructed from a mixture of 80-98% by mass calcium phosphate particles, 1-20% by mass anhydrous polyethylene glycol 400, and 1-20% by mass anhydrous polyethylene glycol 600. Polyethylene glycol 400 and polyethylene glycol 600 can also contain oxidation stabilizers, in addition. [0084] FIG. 3 provides detailed images of the x-ray powder diffractograms of (1) the initial batch of a β-TCP ceramic (2) β-TCP in hyaluronic acid solution (3) β-TCP in dextran solution (4) β-TCP in methylcellulose solution after 12 weeks' storage in water. [0089] As can be seen from this documentation, in the inventive formulation there is no conversion to a different phase of the calcium phosphate family. [0090] FIG. 4 provides detailed images of the x-ray powder diffractograms of (1) the initial batch of a β-TCP ceramic (2) the same ceramic after 12 weeks' storage in water [0093] As can be seen from this documentation, in the aqueous suspension there was partial conversion/recrystallization of β-TCP to hydroxyapatite. [0094] The inventive preparation can be sterilized with dry heat or using gamma rays at a dosage of 8 to 30 kGy (=Kilograys). [0095] The hyaluronic acid used for the inventive preparation or the hyaluronic acid salts can be bioengineered, the hyaluronic acid having a molecular weight of 1,500,000 to 4,500,000 Daltons and sterilization reducing this to 700,000 to 2,500,000 Daltons. [0096] The invention shall be explained using examples in the following, but the invention shall not be limited to these examples. [0097] Components A through K can be used for producing the plastically deformable implant material. Component A: [0098] Sodium hyaluronate, bioengineered with a molecular weight of 2.5 MDa Component B: [0099] 99% β-tricalcium phosphate, free of phase shift, polygonally broken, the broken edges rounded by abrasion and subsequent burning, having a porosity of 20±5% and particle size distribution of 0.1-50 μm, bulk density of 1.1±0.1 g/cm 3 , and grain size of <63 μm (d 50 =15±5 μm) Component C: [0100] Warm water for injection (30° C.) Component D: [0101] Low-viscosity methylcellulose Component E: [0102] High-viscosity methylcellulose Component F: [0103] High-viscosity hydroxypropyl cellulose Component G: [0104] Low-viscosity hydroxypropyl cellulose Component H: [0105] Polyethylene glycol 400 Component I: [0106] Polyethylene glycol 20,000 Component K: [0107] Dextran Example 1 [0108] 0.3 g Component A are added to 20.05 g Component C. After a 4-hour swelling time, the gel is sterile-filtered, slowly added to a total of 50 g Component B, and mixed intimately. The mixture is sterilized in a container at 121° C. using dry heat. [0109] The result is a homogenous mixture with a paste-like consistency that is easily extruded through a cannula, conforms to a defect due to plastic flow, and that air easily hardens superficially, it being possible to accelerate this process using a gentle airflow from a compressed air pistol. After heat sterilization the material has a molecular weight of 1.7±0.5 MDa. [0110] Even after 4 hours of centrifuging, no solid or liquid settles out. An extruded paste adheres well to surrounding tissue. An extruded and superficially dried body retains its shape in the simulated body environment (moist chamber under physiological conditions). Example 2 [0111] 0.2 g Component A are added to 20.0 g Component C. After a 4-hour swelling time, the swollen gel is sterile-filtered, slowly added to a total of 63.4 g Component B while stirring, and mixed intimately. The mixture is sterilized in a closed container at 121° C. using dry heat. [0112] The result is a homogenous mixture that has a plastic consistency and is kneadable, that because of its kneadability is easily applied to a bone defect, that adheres well to the surrounding tissue, and that air easily hardens superficially, it being possible to accelerate this process using a gentle airflow from a compressed air pistol. After sterilization the material has a molecular weight of 1.7±0.5 MDa. [0113] Even after 4 hours of centrifuging, no solid or liquid settles out. A hand-formed and superficially dried body retains its shape in the simulated body environment (moist chamber under physiological conditions). Example 3 [0114] 225 mg Component D are added to 38 mg Component A, and then 9.7 g Component C is added while stirring. After a 1-hour swelling time, the swollen gel is sterile-filtered, slowly added to a total of 22 g Component B while stirring, and mixed intimately. The mixture is sterilized in a closed container at 121° C. using dry heat. [0115] The result is a homogenous mixture with a paste-like consistency that is easily extruded through a cannula, conforms to a defect due to plastic flow, and that air easily hardens superficially, it being possible to accelerate this process using a gentle airflow from a compressed air pistol. Even after 4 hours of centrifuging, no solid or liquid settles out. A large quantity of the material does not result in an aqueous solution settling on the surface, even after standing for a number of weeks. An extruded paste adheres well to surrounding tissue. An extruded and superficially dried body retains its shape in the simulated body environment (moist chamber under physiological conditions). Example 4 [0116] 200 mg Component E are mixed with 100 mg Component A, and then 19 g Component C are added while stirring. After a 1-hour swelling time, the swollen gel is sterile-filtered, slowly added to a total of 58 g Component B while stirring, and mixed intimately. The mixture is sterilized in a closed container at 121° C. using dry heat. [0117] The result is a homogenous mixture that has a plastic consistency and is kneadable, that because of its kneadability is easily applied to a bone defect, that adheres well to the surrounding tissue, and that air easily hardens superficially, it being possible to accelerate this process using a gentle airflow from a compressed air pistol. Even after 4 hours of centrifuging, no solid or liquid settles out. A large quantity of the material does not result in an aqueous solution settling on the surface, even after standing for a number of weeks. A hand-formed and superficially dried body retains its shape in the simulated body environment (moist chamber under physiological conditions). Example 5 [0118] 500 mg Component F are mixed with Component C to make 10.0 g. After a 4-hour swelling time, the swollen gel is sterile-filtered, slowly added to a total of 27 g Component B while stirring, and mixed intimately. The mixture is sterilized in a closed container at 121° C. using dry heat. [0119] The result is a homogenous, plastic mass that is kneadable, that because of its kneadability is easily applied to a bone defect, that adheres well to the surrounding tissue, and that air easily hardens superficially, it being possible to accelerate this process using a gentle airflow from a compressed air pistol. Even after 4 hours of centrifuging, no solid or liquid settles out. A hand-formed and superficially dried body retains its shape in the simulated body environment (moist chamber under physiological conditions). Example 6 [0120] 500 mg Component G are mixed with Component C to make 10.0 g. After a 4-hour swelling time, the swollen gel is sterile-filtered, slowly added to a total of 22 g Component B while stirring, and mixed intimately. The mixture is sterilized in a closed container at 121° C. using dry heat. [0121] The result is a homogenous, paste-like mixture that is easily extruded through a cannula, conforms to a defect due to plastic flow, and that air easily hardens superficially, it being possible to accelerate this process using a gentle airflow from a compressed air pistol. Even after 4 hours of centrifuging, no solid or liquid settles out. An extruded paste adheres well to surrounding tissue. An extruded and superficially dried body retains its shape in the simulated body environment (moist chamber under physiological conditions). Example 7 [0122] Sterile filtration is performed in 1.9 g Component H. Then 5 g Component B are added slowly while stirring. [0123] The result is a paste that can flow plastically and that is easily extruded through a syringe. The material can easily flow plastically into the intermediate spaces of a defect. [0124] Even after multiple hours of centrifuging, the TCP particles remain in suspension. The material is very suitable for a bone construction material, especially for complicated defects. Example 8 [0125] 2.0 g Component I are mixed with Component C to make 10.0 g and after homogenization are sterile filtered. After 25 g Component B are added the material is mixed intensively. The result is a paste that has good plastic flow and that is easily extruded through a syringe. The material has plastic flow and therefore is ideal for filling intermediate spaces in a defect and adheres to the surrounding tissue. [0126] Even after multiple hours of centrifuging the TCP particles remain in suspension. The material is very suitable for bone construction material, especially for complex defects. Example 9 [0127] 0.2 g Component I are mixed with Component H to make 10.0 g and after homogenization are sterile filtered. After 25 g Component B are added the material is mixed intensively. [0128] The result is a non-extrudable, kneadable paste that is slightly elastic and is shapeable like wax. Because of its shapability, the material can be matched well to different defects and remains in the defect temporarily as a placeholder. [0129] Even after multiple hours of centrifuging the TCP particles remain in suspension. The material is very suitable for bone construction material, especially for complex defects. Example 10 [0130] 3.0 g Component K are mixed with Component C to make 10.0 g. Once Component K has dissolved, the material is sterile filtered and added to 26.3 g Component B. [0131] The result is a paste that extrudes well through a syringe and that is shapeable and does not drip from the cannula. Because of its shapability, the material can be matched well to different defects and remains temporarily in the defect as a placeholder. [0132] Even after multiple hours of centrifuging the TCP particles remain in suspension. The material is very suitable for bone construction material, especially for minimally-invasive applications. Example 11 [0133] 300 g Component D are mixed with Component C to make 10.0 g. After a 1-hour swelling time, 25 g Component B having the mean grain sizes according to the table below are added and mixed intimately. The result is a paste-like mass, the extrudability of which is tested using different cannula diameters. [0134] Extrudability is documented in the table below and indicates the suitability of various particle diameters for producing an extrudable paste. [0000] Extrudability Extrudability D 10 D 50 D 90 through cannula through cannula Sample [μm] [μm] [μm] having Ø 0.8 mm having Ø 2.0 mm 1 1.60 9.65 20.28 ++ +++ 2 2.20 15.23 35.77 + +++ 3 10.14 27.15 44.42 −− ++ 4 14.89 35.52 63.60 −−− + 5 19.35 44.48 78.15 −−− − +++ = very good (good and homogeneous extrudability) ++ = good to very good (good extrudability) + = good to moderate (satisfactory extrudability, slight resistance can be detected from canting of individual particles) − = moderate (adequate extrudability, significant resistance due to canting of particles) −− = difficult (poor extrudability, particles cant rapidly) −−− = very difficult (not extrudable at all, significant canting). [0135] The advantage of the inventive composition is that a phase and sedimentation-stable, plastically deformable implant material with intrinsic pore formation is provided that can be created such that it does not migrate much and is inserted into a bone defect by injection or alternatively can be applied to/fitted in a bone defect as a kneadable mass. [0136] In the inventive composition, the liquid or paste components that are soluble in water stabilize the biologically active polygonally broken rounded particles that are difficult to dissolve in water and that are in the size range of 0.1-150 μm having pores in the size range of 0.01-50 μm such that they do not convert to other phases or substances due to a dissolution/recrystallization process. [0137] Moreover, with the inventive application of the paste-like implant material/the inventive composition, the water-soluble organic binder substance with the particulate biologically active substance forms a porous structural accumulation that is dimensionally stable when applied, the easily soluble components being exchanged for fibrous tissue in the defect environment so that the porous particle packing remains dimensionally stable and is slowly integrated, vascularized, and resorbed. [0138] All of the features described in the following claims and in the drawings can be essential to the invention, both individually and in any combination with one another.

1a

FIELD OF THE INVENTION The present invention relates generally to a metallic hollow golf club head, and specifically, to the placement of a stamped insert into the face of the club. This invention is also directed to a weight element being located on the sole in the heel/skirt regions of the club. BACKGROUND OF THE INVENTION Golf club “metal woods”, were originally manufactured primarily by casting of durable metals such as stainless steel, aluminum, beryllium copper, etc. into a unitary structure comprising of a metal body, face and hosel. As technology progressed it became more desirable to strengthen the face of the club, and usually this was achieved by using a titanium material. With a high percentage of amateur golfers constantly searching for more distance on their drives, the golf industry has responded by providing golf clubs specifically designed with distance in mind. The head sizes have increased which allows for the club to possess a higher moment of inertia, which translates to a greater ability to resist twisting on off-center hits. As a wood head becomes larger, its center of gravity will be moved back away from the face resulting in hits flying higher than expected. Reducing the lofts of the larger head clubs can compensate for this. Also the larger heads, because the center of gravity is moved further away from hosel axis, can cause these clubs to remain open on contact, thereby inducing a “slice” effect (in the case of a right-handed golfer the ball deviates to the right). Offsetting the head and incorporating a hook face angle can help compensate for this by “squaring” the face at impact, but often more is required to eliminate the “slice” tendency. The present invention provides such a solution. Another technological breakthrough in recent years towards providing the average golfer with more distance is to make larger head clubs, while keeping the weight constant or even lighter, by casting consistently thinner shell thickness and going to lighter materials such as titanium. Also the face of the clubs have been steadily becoming extremely thin. The thinner face will maximize what is known as the COR (Coefficient of Restitution). The more a face rebounds upon impact, the more energy that may be imparted to the ball, thereby increasing distance. In order to make the faces thinner, manufacturers have moved to a forged or stamped metal face which are stronger than cast faces. Common practice is to attach the forged or stamped metal face by welding them to the body at the sole and crown junctions. The present invention provides a novel method for attaching an impact face to the club without sacrificing any COR (Coefficient of Restitution) value in the club. The prior art teaches methods to enhance the weight distribution of metal woods to help reduce the club from being open on contact with the ball. Usually, this is accomplished by the addition of weights to the body casting itself or strategically adding a weight element at some point in the club. Many efforts have been made to incorporate weight elements into the metal wood head. They are usually placed at specific locations, which will have a positive influence on the flight of the ball or to overcome a particular golfer's shortcomings. As previously stated, a major problem area of the higher handicap golfer is the tendency to “slice” which besides deviating the ball to the right, also imparts a greater spin to the ball. To reduce this tendency, the present patent teaches the placing of a weight element directly into the club head. The placement of the weight is designed so that the spin of the ball will be reduced, and also a “draw” (a right to left ball flight for a right-handed golfer) will be facilitated into the ball flight. This ball flight pattern is also designed to help the distance challenged golfer because a lower spinning ball will generally roll a greater distance after hitting the ground than it would roll with a higher spin. The present invention provides such a golf club. Several patents have been issued which are directed towards using an insert in the face of the club to increase the strength therein. One such patent, U.S. Pat. No. 5,344,140 issued to Anderson, cites a face plate of forged metal. None of the above inventions and patents, either singly or in combination, is seen to describe the instant invention as claimed. SUMMARY OF THE INVENTION In accordance with one aspect of the invention, a metal wood golf club head is provided which includes a hollow body having a stamped metal impact face welded to it. The body is preferably cast as a single member and includes an inner cavity surrounded by a sole plate, a crown portion, a toe portion, a heel portion, a skirt portion and a face perimeter forming an oval opening. The present invention utilizes a sheet metal insert that is preferably placed into the face approximately 0.20″ removed from the crown portion and 0.20″ removed from the sole plate. The face insert should be at least 0.15″ from either the crown portion or the sole plate. The shell of the face perimeter is preferably of uniform thickness and less than the thickness of the insert. The insert preferably has a thickness that varies based on a double radii method that is described later. In accordance with another aspect of the invention, the club head includes the addition of a weight element to the sole plate. The purpose of this weight addition is to reduce the tendency of a golfer to slice and to lower the spin rate of the ball, which actually tends to increase distance. The weight element is centered substantially on a projection extending away from and generally perpendicular to the impact face on a line through a point where the shaft centerline would meet the sole plate. The center of gravity of the weight element is thus substantially directly behind the point where the hosel axis intersects the sole plate. Preferably, the weight element is placed at a juncture of the heel/skirt portions of the sole plate. The weight element may be either cast with the body or can be a separate piece attached to the sole plate by conventional means such as welding. The center of the weight element should be at least 1.0″ and preferably more than 1.5″ from the intersection point of the hosel centerline and the sole plate. It is anticipated that the weight element be greater than 12 grams and more preferably greater than 16 grams. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view of the present invention showing cut out section and stamped metal insert. FIG. 2 is a side view of the impact insert of FIG. 1 . FIG. 3 is a partial top view showing the intersection point where the centerline of the hosel meets the sole plate. FIG. 4 is a partial cross-sectional side view of a golf club head with a face having a different interior and exterior vertical roll radii. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIGS. 1-5, showing the first embodiment of the present invention, there is provided a golf club head 10 , which is integrally formed by welding and combining the edges of a body 11 with an impact insert 12 so as to form a cavity 13 therein. The body 11 includes a crown portion 14 , a sole plate 15 , a heel portion 16 , a toe portion 17 , a skirt portion 18 and a face perimeter 19 . Body 11 can be formed of sheets welded together or cast, preferably from a titanium alloy. The body also includes a hosel 20 that extends from heel portion 16 . Hosel 20 includes a bore defining a centerline axis A—A. An opening 21 , that in one embodiment is substantially oval shaped, is defined within face perimeter 19 for receiving impact insert 12 . A plurality of chads 22 , being in alignment with an inner surface 23 of body 11 provide a pocket within opening 21 for receiving the impact insert 12 which is therein integrally connected by welding. Insert 12 is preferably formed of high strength material and can be cast, forged or stamped sheet metal. Most preferably the insert is stamped sheet metal, and for one embodiment preferably made from a titanium alloy. The thickness of the impact insert 12 should be preferably between about 0.05″ and 0.13″. The insert can be uniform thickness or have a thicker center section and thinner outer section. For a preferred embodiment the outer dimension (T 2 ) should be about 0.09″ and the center dimension (T 3 ) should be approximately 0.10″ controlled by a technique described in co-pending application Ser. No. 09/836,266. It's basically a technique wherein the impact insert 12 has two different radii of curvature. The exterior surface 24 being substantially defined along a first radius R 1 and the interior surface 25 being substantially defined along a second radius R 2 , such that the first radius R 1 is less than the second radius R 2 . The present invention further is adapted towards the face having a vertical roll radius: that being from crown 14 to sole 15 . This will allow insert 12 to have less thickness at the outer edge than at the center. The thickness of the impact insert 12 is viewed as a critical compromise between first, being able to achieve the desired “COR”, and secondly, providing a club head that is strong enough to withstand the impact forces which occur during collision between club and ball. In one embodiment of the present invention, the edges 27 of face perimeter 19 are as thin as possible, while still maintaining structural integrity. Preferably the thickness (T 1 at the sole/face transition junction 29 and T 4 at the crown/face transition junction 28 ) is approximately the same and is less than 0.11 inches. More preferably, they are less than 0.09 inches and most preferably approximately 0.08″ for maximum COR values. In a preferred embodiment of the present invention, the body 11 includes a face perimeter section 19 that extends from the crown portion 14 over a distance (denoted as Δ 1 in the drawings), of at least about 0.15 inches, and also over a distance of about 0.15 inches from the sole plate 15 (Δ 2 in drawings). The welds 30 of impact insert 12 to body 11 will be conducted at a suitable distance from the transition junctions 28 and 29 . The dimensions of both Δ 1 and Δ 2 are preferably should not less than 0.20 inches. This construction allows for thin shell thickness at the crown/face transition junction 28 and sole/face transition junctions 29 . The thinness of these sections help increase the club head's COR value that extrapolates into greater distance. In a second embodiment, the body 11 can still be cast from a titanium alloy, but the stamped impact insert 12 can be a stamped titanium alloy sheet metal. The thickness of the impact insert 12 for this embodiments can be a constant measurement of about 0.08 to 0.13 inches for T 1 , T 2 , T 3 and T 4 . For another embodiment, the body 11 and stamped impact insert can be manufactured out of stainless steel. Preferably, the head is more than 270 cubic centimeters and the body is cast and the insert is stamped sheet metal. The thickness of the impact insert 12 for this embodiment is preferably a constant measurement of between about 0.075″ to 0.105″ for T 1 , T 2 , T 3 and T 4 . In another embodiment the club head loft is greater than 13° and the inserts 12 have a constant thickness between about 0.05″ to 0.09″. Another important design concept of the present invention is providing a weight element 26 located on the sole plate 15 approximately at the heel/skirt portions 16 and 18 . As shown in FIGS. 1 to 5 , weight element 26 is preferably centered substantially on a projection B—B extending directly rearward from a point (P) on the sole plate where an extension of the center line A—A of hosel 20 would intersect the sole plate 15 . Preferably, the center of gravity of the weight element 26 is adjacent the juncture of the sole and skirt portions 16 and 18 . It is preferred that the center of weight element 26 be located at a distance (D) of at least 1.0″ and more preferably at least 1.5″ from the intersection point P. This is shown on FIG. 3 . The weight element 26 is preferably at least 12 grams and more preferably at least 16 grams. The weight element 26 can be part of the casting or preferably welded into position. More preferably, the weight element 26 is selected from a plurality of weights designed to make specific adjustments to the head weight. While various descriptions of the present invention are described above, it should be understood that the various features of each embodiment can be used singly or in any combination thereof. Therefore, this invention is not to be limited to only the specifically preferred embodiments depicted herein. Further, 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. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention is accordingly defined as set forth in the appended claims.

1a

BACKGROUND OF THE INVENTION The present invention relates to an arrangement for applying an adhesive medium, particularly for leather and shoe articles. More particularly, it relates to an arrangement for applying an adhesive medium which has an adhesive medium applying nozzle, and a nozzle needle member which closes and opens the nozzle. Arrangements of the abovementioned general type are known in the art. In a known arrangement an adhesive medium applying nozzle cooperates with a nozzle needle member which has an end portion connected with a longitudinally displaceable driver. The driver is coupled with a driving device which respectively displaces the driver and thereby displaces the nozzle needle member relative to a nozzle needle. One of such arrangements for applying an adhesive medium is disclosed, for example, in our DE-OS 3,108,793. In practical use of such arrangements, it is frequently desirable to supply different quantities of the adhesive medium per time unit in correspondence with the various applications of the arrangement. This can be done with the known arrangements for applying an adhesive media and spraying pistols only in such a manner that different quantities of discharge adhesive medium can be adjusted manually. Such a manual adjustment is, however, complicated and very rime consuming in the event of frequent changes in the quantity of adhesive medium to be applied. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide an arrangement for applying medium, especially to leather and shoe articles, which avoids the disadvantages of the prior art. More particularly, it is an object of the present invention to provide an arrangement for applying an adhesive medium especially to leather and shoe articles, in which different quantities of adhesive medium can be applied easier and faster than in the known arrangements of the above-described type. In keeping with these objects and with others which will become apparent hereinafter, one feature of the present invention resides, briefly stated, in an arrangement for applying an adhesive medium which has an adhesive medium applying nozzle, a nozzle needle member cooperating with the nozzle so as to close and to open the same, and at least two selectively actuatable drive units which act on the nozzle needle member so as to provide different strokes of the nozzle needle member. When the arrangement for applying an adhesive medium is formed in accordance with the present invention, different quantities of adhesive medium per time unit can be applied by selective actuation of the respective drive unit for the nozzle needle member. The desired quantities of adhesive medium can be adjusted by adjusting of the individual drive units. A user no longer has to adjust the individual desired quantities in one adjusting device, but instead he just has to release the respective drive units. In accordance with another advantageous feature of the present invention, the drive units are formed as two coaxial cylinder-piston units which can be pneumatic or hydraulic. The piston rod of one of the cylinder-piston units is connected with the cylinder of the other cylinder-piston unit, and the piston rod of the other cylinder-piston unit is connected with a displaceable driver for the nozzle needle member. In accordance with a further feature of the present invention, the displacement paths of the pistons of the drive units can be limited by means of individual abutments so as to adjust the desired quantity of an adhesive medium to be applied per time unit. The inventive arrangement for applying an adhesive medium is therefore used with fully automatic operation, and the time interval of operation of the drive units can be preselected in advance. Normally, the inventive arrangement for applying adhesive medium is designed for a switching impulse which is automatically limited in time and is releasable by a user. The novel features which are considered as characteristic for the invention are set forth in particular in the appended claims. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWING The single FIGURE of the drawing is a view schematically showing a longitudinal section of an arrangement for applying an adhesive medium in accordance with the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS An arrangement for applying adhesive medium in accordance with the present invention has a housing which is provided with a hollow cylindrical wall 10 and end walls 11 and 33. A nozzle needle 12 extends through the end wall 11 outwardly of the housing and has a tip 13. In the inoperative position, the tip 13 closes an outlet opening 14 of an adhesive medium applying nozzle 15. The nozzle 15 is screwed into a threaded opening of a partially shown housing part 16. The housing part 16 bounds a receiving chamber 17 for a not shown adhesive medium which is accommodated in the chamber 17 under pressure. The nozzle needle 12 is filled from the adhesive medium receiving chamber 17 by means of a rubber seal 18. The seal 18 is tightly mounted on the inner side of the end wall 11, on the one hand, and on the nozzle needle 12, on the other hand. The nozzle needle 12 has an inner end and is widened at this end so as to form a head 19. The head 19 is retained in an adjusting screw 20. The adjusting screw 20 is a part of a longitudinally displaceable driver 21. The adjusting screw 20 extends into screw nut 22 of the driver 21. The driver 21 is mounted on an outer end of a piston rod 23 of a first cylinder-piston drive unit 24. The piston rod 23 leads to a piston 26 which is arranged in a cylinder housing 25 of the first drive unit 24 and is acted upon at one side by a pressure air. The piston 26 is displaceable against the force of return spring 27 which is also located in the cylinder housing 25. The first drive unit 24 has a pressure chamber 28 which communicates via a connecting opening 29 and via a not shown switching device with a not shown source of pressure air. A second drive unit 30 is arranged coaxially with the first drive unit 24. The second drive unit 30 has a cylinder housing 31 which is anchored by means of a screw 32 in the end end wall 33 of the housing 10 which is spaced from the nozzle. The cylinder housing 31 has a pressure chamber 34 which communicates via a connecting opening 35 and a not shown second switching device with the abovementioned source of pressure air. The second drive unit 30 has a piston 36 which is displaceable against the force of a return spring 37. A piston rod 38 is connected with the piston 36 and has an outer end with which it is screwed in a closing plate 39 of the cylinder housing 25, and the closing plate 39 is fixedly connected with the cylinder housing 25 of the first drive unit 24. In both selectively actuatable drive units 24 and 30, the piston 26 of the first drive unit 24 is coupled via the driver 21 with the nozzle needle 12, while the piston 36 of the second drive unit 30 is coupled with the cylinder housing 25 of the first drive unit 24. When the first drive unit 24 is actuated by the pressure air supply into the pressure chamber 28 and its piston 26 is displaced against the force of the return spring 27, the driver 21 with the needle nozzle 12 is taken along by the piston rod 23. The displacement path of the piston 26 and thereby the displacement path of the nozzle needle 12 is limited by the value A which is determined by a first abutment nut 40 that is concentrically screwed on the cylinder housing 25. When the second drive unit 30 is actuated by supplying pressure air into the pressure chamber 34, the piston 36 displaces via the piston rod 38 the cylinder housing 25 of the first drive unit 24 and thereby also the driver 21 with the nozzle needle 12. The displacement movement of the piston 36 of the second drive unit 30 is adjusted to a value B which is for example greater than the value A and is determined by a second abutment nut 41 mounted on the cylinder housing 31 of the second drive unit 30. The housing 10 can accommodate more than two drive units arranged with the abovedescribed coupling, so that more than two different displacement paths for the needle nozzle 12 can be performed. The not shown switching device can be formed so that each drive unit 24 and 30 obtains a pressure impulse of an equal length which leads because of the different adjustments of the abutment nuts 40 and 41, to different displacement movements of the needle nozzle 12. On the other hand, the switching devices can be also formed so that the individual drive units 24 and 30 are actuated during different time periods. In any case, the abutment nut on the individual drive unit must be adjusted only once for feeding of the desired adhesive medium, which then can be applied by releasing of the switching device. Depending on the actuation of one or the other drive unit, the adhesive medium applying arrangement can discharge during its operation, for example on a shoe part, either a smaller or a wider adhesive medium line. It will be understood that each of the elements described above, or two or more together, may also find a useful application in other types of constructions differing from the types described above. While the invention has been illustrated and described as embodied in an arrangement for applying adhesive medium, it is not intended to be limited to the details shown, since various modifications and structural changes may be made without departing in any way from the spirit of the present invention. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic or specific aspects of this invention.

1a

This application is a continuation of Application No. 08/564,936, filed Nov. 30, 1995, now abandoned which is a continuation of Application No. 08/233,046, filed Apr. 25, 1994, now abandoned. BACKGROUND OF THE INVENTION This invention relates to endoprosthesis devices, generally called stents, and, more particularly, radiopaque markers for use with endoprosthesis devices. Stents are useful in the treatment of atherosclerotic stenoses in blood vessels and are generally tubular shaped devices which function to hold open a segment of a blood vessel or other anatomical lumen. They are particularly suitable for use in supporting and holding back a dissected arterial lining which can occlude the fluid passage way therethrough. In order to accomplish precise placement of stents, various means are employed to identify the position of the stent within a blood vessel. One means frequently described for accomplishing precise placement of a stent is the attachment of radiopaque markers to the stent so that through the use of fluoroscopy, the position of the stent within a blood vessel can be identified. Once the stent with its radiopaque markers has been implanted, subsequent checkups of the treated segment are easily performed since the markers remain visible under fluoroscopy. Conventional radiopaque markers, however, have various limitations. Upon attachment to a stent, certain conventional radiopaque markers define a profile that is readily discernible from that of the stent, thereby comprising projections which may undesirably alter the contemplated profile of the stent. That is, these conventional radiopaque markers protrude from the walls of the stent and depending upon their location upon the stent, may either project into the blood flow or into the walls of the blood vessel. In addition, these conventional radiopaque markers are limited in that their attachment to the stent can be tedious and imprecise. Other conventional radiopaque markers restrict the expansion capabilities of an expandable stent by adding rigidity to the stent in areas designated for stent deformation. Still other conventional stents utilize material, such as tantalum, that is effective for use in identifying the location of a stent within a vessel, but fluoroscopically illuminate so brightly so as to obscure proper visibility of the blood vessel lesion, thereby impairing the ability to repair the lesion. Finally, conventional radiopaque markers do not generally, under fluoroscopy, provide the operator with means to accurately assess stent length and diameter. To overcome the problems and limitations associated with stents having conventional radiopaque markers, it would be desirable to employ radiopaque markers that can be consistently and precisely attached to a stent, that do not limit the expansion capabilities of an expandable stent, that define an acceptable profile, that provide means to assess stent length and diameter and that do not obscure the blood vessel lesion being repaired. The present invention embodies these characteristics. SUMMARY OF THE INVENTION The invention provides a radiopaque marker that may be consistently and precisely affixed to a stent, that does not limit the expansion capabilities of an expandable stent, that has an acceptable profile and that may effectively identify the position, diameter and length of a stent within a blood vessel without obscuring a lesion being repaired. The invention also provides means for affixing to a stent a radiopaque marker having the aforementioned characteristics. The radiopaque marker of the present invention may be utilized with stents having various geometric shapes and materials. In addition, the radiopaque markers may be positioned anywhere on a stent and may comprise any plateable radiopaque material having various patterns. Further, any acceptable means for affixing the radiopaque marker to a stent may be employed. It is essential, however, that the means for attaching a radiopaque marker, its location upon a stent as well as the material and geometric shape of the stent, be selected so that a stent incorporating the radiopaque marker of the present invention may benefit from the advantages provided thereby. In a preferred embodiment, the radiopaque markers of the present invention are affixed to both a distal and a proximal end of a generally cylindrical stent. In this embodiment, the radiopaque marker material is gold and is affixed to the outside circumference of a generally cylindrical stent by means of plating. Although gold is the designated material of this embodiment, other biocompatible plateable radiopaque materials, such as platinum, are equally desirable. Plating is preferable since it can be performed easily and with accuracy and can be utilized to produce an acceptable radiopaque marker profile. It is contemplated that the thickness of the radiopaque marker material upon a stent be in the range of about 0.0003 to 0.003 inches on the exterior surface of the stent, and if required for fluoroscopic illumination, the same thickness can be plated to the inner stent surface. It is also contemplated that the stent may comprise any material, for example any metal or plastic, upon which gold may be plated. Although radiopaque material may be plated on only a portion of the circumference of the stent, in a preferred embodiment it is contemplated that the entire circumference of the stent be plated, thereby producing a stent with a band of radiopaque material at its distal and proximal ends. Moreover, it is significant that only the ends of the stent are plated and that gold, or a similarly effective material, may be selected as the plating material. Plating provides controlled deposition of the radiopaque material on the stent thereby controlling its fluoroscopic illumination. By plating only the two ends of the stent, the fluoroscopic illumination is thus limited to the ends of the stent. These two features minimize the possibility of obscuring the fluoroscopic visualization of the blood vessel being treated. In addition, by plating with radiopaque material at both ends and upon the outside of a generally cylindrical stent, not only can the location of the stent be determined under fluoroscopy, but the length and diameter as well. This is particularly useful where the subject stent is expandable since the degree of expansion can be ascertained by noting the height of the radiopaque marker and the relative distances between the radiopaque markers. Further, it can be determined under fluoroscopy whether or not the stent is twisted or otherwise improperly seated within a blood vessel. In order to successfully plate gold, or any acceptable radiopaque marker material upon a stent, the stent is placed upon a mandrel, masked and plated. In a preferred procedure, the stent is placed upon an elongated cylindrical mandrel, masked with shrink tubing, portions of which are lased away to expose the areas of the stent desired to be plated and thereafter, plated with the desired radiopaque material. It is contemplated that the mandrel may comprise annular recesses which function to allow portions of an interior circumference of a stent, as well as the exterior of the stent, to be plated. Subsequent to the completion of the plating procedure, in a preferred procedure the shrink tubing is detached from the stent and the stent removed from the mandrel. It is contemplated that the shrink tubing may be cut from the stent utilizing a laser. Alternatively, the shrink tubing may be dissolved with chemicals. It is also contemplated that the shrink tubing be pre-fabricated or cut to size (by means of a laser) to precise dimensions so that it may properly perform its masking function. Since a preferred embodiment contemplates gold plating as the avenue for affixing radiopaque markers to a stent and since the gold plating may stiffen the stent in the areas of plating, it is contemplated that expandable stents may be plated in areas where additional rigidity does not affect the expansion capabilities of the stent. Thus, portions of a stent that do not deform upon expansion are plated with gold or the desired radiopaque material. In this way, the stent can freely and uniformly expand and elastically deform without additional restrictions, thereby accomplishing its expansion function while still benefitting from the advantages of the present invention. In another embodiment, the entire exterior surface of a stent is plated with radiopaque material. Thereafter, the portions designated to retain radiopaque material are masked and the radiopaque material is etched away from the remaining portions of the stent. In yet another embodiment a generally cylindrical stent is fitted with radiopaque markers having some geometrical configuration or placed upon a stent in some pattern. For instance, a radiopaque marker may comprise a sine wave pattern so that under fluoroscopy, the configuration of the stent may be quickly ascertained. That is, it can be readily ascertained whether the stent is improperly twisted or contorted and in the case of an expandable stent, whether the stent has been properly deformed. Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A illustrates a partial view of a stent embodying radiopaque markers. FIG. 1B illustrates a partial view of another stent embodying radiopaque markers. FIG. 2A illustrates a schematic view of a stent embodying radiopaque markers. FIG. 2B illustrates a schematic view of another stent embodiment having radiopaque markers. FIG. 3A illustrates a perspective view of a mandrel having annular recesses. FIG. 3B illustrates a perspective view of a mandrel without annular recesses. FIG. 4A illustrates a partial cross-sectional view of a masked stent loaded upon a mandrel having annular recesses. FIG. 4B illustrates a partial cross-sectional view of a masked stent loaded upon a mandrel without annular recesses. FIG. 5 illustrates a schematic view of the stent having two rows of radiopaque material along the longitudinal axis in addition to the radiopaque material on either end of the stent. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As is shown in the drawings, which are included for purposes of illustration and not by way of limitation, the invention is embodied in a radiopaque marker 10 (FIGS. 1A, 1B, 2A, 2B, and 5). Conventional radiopaque markers are limited in that they may comprise undesirable projections extending from a stent, may be arduous to attach, restrict the expansion capabilities of an expandable stent and may be ineffective in the identification of the position, orientation and configuration of a stent. The radiopaque marker 10 of the present invention defines an acceptable, very low profile, may be conveniently affixed to a stent, does not impede the expansion capabilities of an expandable stent, and may be useful in identifying the position, orientation and configuration of a stent within a blood vessel. The radiopaque marker of the present invention, therefore, provides superior means of marking a stent. The present invention facilitates precise placement of a stent 12 by way of its novel configuration, position upon a stent, and material properties. The characteristics of a radiopaque marker 10 are selected to assure that a stent 12 embodying the radiopaque marker 10 may benefit from the advantages which the invention provides. Thus, radiopaque marker 10 may have various geometric shapes, comprise various materials and may be positioned anywhere on a stent 12, so long as the desired advantages of the invention are achieved. While stent 12 can include any number of configurations, one preferred embodiment includes a plurality of cylindrical elements 13 which are interconnected so as to be generally aligned on a common longitudinal axis. Stent 12 includes proximal end 14 and distal end 16, and cylindrical elements 13 are attached by one or more connecting elements 17. The connecting elements 17 interconnect the cylindrical elements so that each connecting element 17 connects only cylindrical elements that are adjacent to each other. Each cylindrical element is formed from straight segments 18 connected by curved portions 20 which together form a generally serpentine pattern 21. In a preferred embodiment, radiopaque marker 10 is plated upon an outer circumference of a generally cylindrical stent 12 and upon a proximal end 14 and a distal end 16 of the stent 12. In another embodiment, it is contemplated that an inner circumference underlying the outer circumference be plated as well. By utilizing plating as the means for affixing radiopaque marker 10 to a stent 12, a minimum profile may be achieved. It is contemplated that the thickness of radiopaque marker 10 be in the range of about 0.0003 to 0.003 inches. As such, the radiopaque marker 10 does not appreciably alter the profile of stent 12 and therefore, does not result in stent 12 having substantial projections extending into the blood flow or into the walls of the blood vessel being repaired. In addition, by plating or similarly affixing radiopaque material upon a stent, radiopaque markers 10 can be easily and accurately affixed to a stent. That is, plating is an improved means of affixing radiopaque material to stent 12 over conventional means of affixing radiopaque markers, such as sewing or bonding, which can be tedious and imprecise. Although it is not necessary for all embodiments, the preferred embodiment contemplates that the entire circumference of the stent be plated at both its proximal end 14 and distal end 16. It is also contemplated that the plating material may be gold or a material, such as platinum, which has similar radiopaque characteristics. It is significant that gold, or a similar material, is contemplated as the preferred radiopaque marker material. Other metals suitable as radiopaque markers include, for example, platinum and silver. By selecting such a material, the stent may be effectively identified under fluoroscopy. In various conventional stents, the radiopaque material employed glows so brightly under fluoroscopy so as to obscure the lesion being repaired. In contrast, the images of radiopaque markers comprised of gold or platinum do not, under fluoroscopy, substantially obscure the lesion being repaired. It is also significant that the preferred embodiment contemplates affixing radiopaque markers 10 to the ends of stents 12 having various geometric configurations (see FIGS. 2A and 2B). By doing so, the orientation or configuration of the stent 12, irrespective of its geometric configuration, can be ascertained, which is particularly important to the determination of whether a stent has completely repaired a blood vessel. By noting the distance between the radiopaque bands, the length of the stent 12 can be ascertained and compared to an expected stent length. By observing the height or width of the radiopaque markers 10, the extent of expansion of an expandable stent 12 can be ascertained and compared with expected values. Similarly, by examining the radiopaque markers of the present invention under fluoroscopy, it can be determined whether the stent 12 is twisted or otherwise improperly seated within a vessel. The plating of radiopaque markers upon a stent may add some rigidity to a stent in the areas of plating. Since this is the case, the preferred embodiment contemplates affixing radiopaque markers 10 to only those portions of an expandable stent 12 that do not deform upon expansion. As shown in FIGS. 1A and 1B for example, radiopaque markers 10 may be affixed to straight segments 18 of the proximal end 14 and distal end 16 of a stent. Upon expansion, the curved portions 20 of the stent 12 may deform so as to allow the stent 12 to expand, while the straight portions 18 may remain undeformed. By affixing radiopaque markers 10 to the straight portions 18 of stent 12 as shown in FIGS. 1A and 1B, the additional rigidity added to the stent 12 by the radiopaque markers 10 does not impede expansion. Therefore, an expandable stent having radiopaque markers 10 of the present invention can uniformly and predictably expand. In order to plate a radiopaque marker 10 upon a stent 12, a mandrel 30 may be employed (see FIG. 3A). The mandrel 30 may comprise any suitable material formed into an elongate cylindrical shape having a main portion 21 with a cross-sectional diameter sized for receiving stent 12. The mandrel may further embody a collar 22 formed or attached to one end of the mandrel 30 that has a cross-sectional diameter larger than that of stent 12 and two annular recesses 23 formed in the main portion 21 which have cross-sectional diameters less than that of the main portion 21. The collar 22 functions as a stop and may aid in registering stent 12 upon the mandrel 30. Annular recesses 23 function to allow interior surfaces of stent 12 to be plated. In another embodiment of mandrel 30 (FIG. 3B), recesses 23 may be sufficiently shallow or be missing entirely from mandrel 30 so that, where desirable, interior surfaces of stent 12 are not plated with radiopaque material. In a preferred method, stent 12 is placed upon mandrel 30 and heat shrink tubing 32 (see FIGS. 4A and 4B) is slipped over stent 12. The heat shrink tubing 32 is then exposed to heat to shrink the tubing on the stent 12. It is contemplated that the heat be concentrated at a midpoint of the heat shrink tubing 32 and then gradually apply heat towards each end so as to prevent distortion of the stent. The shrink tubing 32 may be any polyester having heat shrink properties and the ability to mask the stent during the electroplating process. Once the heat shrink tubing 32 is snug upon stent 12, the stent may be precisely positioned on the mandrel 30 and then temporarily secured in place using a high temperature wax. Where it is desired to plate an interior as well as an exterior surface of stent 12, the annular recesses 23 may be aligned with the interior portions of the stent 12 desired to be plated (see FIG. 4A). Where it is deemed undesirable to plate the interior surface, no such further alignment is necessary (see FIG. 4B). Next, the curved portions 20 (FIG. 1B) of stent 12 as well as the ends of the mandrel 30 can be dipped in high temperature wax to prevent them from being plated. In order to plate the desired portions of stent 12, the heat shrink tubing 32 surrounding portions of the stent 12 to be plated may be cut away using a standard CO 2 laser or its equivalent. The laser output is to be limited so that stent 12 and mandrel 30 are not affected. By utilizing a mandrel 30 without annular recesses (see FIGS. 3B and 4B), portions of the heat shrink tubing 32 may be lased away so that only the outer circumferences of stent 12 may be plated. By employing the mandrel 30 illustrated in FIGS. 3A and 4A, portions of the heat shrink tubing 32 overlaying annular recesses 23 may be lased away, thereby resulting in a stent 12 having desired portions of its interior as well as its exterior 12 plated with radiopaque material (see FIG. 2B). As with any electroplating process, an electrical current is used in the process of putting a metallic coating on a metal or other conducting surface. In the preferred embodiment, a gold solution exists in the form of positively charged ions that have lost one or more electrons. The stent is connected to the cathode or negative terminal and the anode, or positive electric terminal, is connected to the stainless steel mandrel 30 which is dipped into the gold solution. The ions are attracted to the cathode and the coating is deposited on the stent metal surface. As is known in the art, the thickness of the layer deposited depends on the amperage of the electric current, the concentration of the metallic ions and the length of time that the stent is plated. The plating process should be at a low enough amperage to prevent mapping, nodules, and a matte surface. After plating the gold on the stent, the wax is removed from stent 12 and mandrel 30 by inserting them in acetone or an equivalent solution. As can be appreciated from the drawings (FIGS. 2A and 2B), the end portions 36,38 of a stent 12 which are not masked, are plated with radiopaque material and the portions of the stent 12 which are masked, are not plated. Once the stent 12 is plated with a radiopaque marker 10, it is removed from the mandrel 30 and the heat shrink tubing 24 is stripped away. The heat shrink tubing 24 may be removed, for example, by cutting it with a laser or in the alternative, dissolved with chemicals. Finally, the mandrel is withdrawn from the plated stent 12 and the stent 12 may be cleaned with an Alcomox or equivalent solution. In another embodiment, the entire exterior surface of a stent may be plated with radiopaque material. Subsequent to plating, the stent 12 is masked and subjected to etching. In this embodiment, the areas designated to retain radiopaque material are masked and the radiopaque material is etched away from the remaining portions of the stent. In yet another embodiment, radiopaque markers having some pattern are affixed to a generally cylindrical stent so as to facilitate the identification, position and configuration of a stent 12 within a blood vessel. For example, the pattern of a radiopaque marker 10 may be in the form of a sine wave. As the sine wave expands along with the stent during deployment, it is visible under fluoroscopy and it can be determined whether the stent 12 is properly seated within a blood vessel by viewing the amplitude and shape of the sine wave radiopaque marker. As another example, as depicted in FIG. 5, the pattern of a radiopaque marker 10 may be a continuous or dashed line extending from the proximal end 14 to the distal end 16 of stent 12. A longitudinal marker of the type described will allow the doctor to determine if the stent has twisted upon deployment or if it expanded unevenly. In an alternative embodiment, a radiopaque plastic may be coated or affixed to all or a portion of a stent. In this embodiment, a radiopaque plastic is formed by loading a plastic material with a radiopaque material such as barium sulfate or bismute trioxide. The resultant mixture is then coated or affixed to the stent. Several methods of affixing the radiopaque material to the stent are contemplated and include: (1) melting the radiopaque material and then dipping the stent into the melt; (2) solvent casting; and (3) vacuum deposition. These methods are generally known and various process steps are apparent to those skilled in the art. As with the plating process steps described above, the stent can be masked and mounted on a mandrel and then coated by dipping, solvent casting, or vacuum deposition. From the foregoing it will be appreciated that the radiopaque marker of the invention effectively identifies the location and configuration of a stent within a patient's body lumen and provides a method and apparatus for constructing the same. While several particular forms of the invention have been illustrated and described, it will also be apparent that various modifications can be made without departing from the spirit and scope of the invention. Thus, it should be understood that various changes in form, and detail, and application of the present invention may be made without departing from the spirit and scope of this invention.

1a

This application is a divisional of U.S. patent application Ser. No. 07/666,840, filed Mar. 8, 1991, the full disclosure of which is incorporated herein by reference. BACKGROUND OF THE INVENTION This invention relates to ophthalmological surgery techniques which employ an ultraviolet laser used to provide ablative photo decomposition of the surface of the cornea in order to correct vision defects. Ultraviolet laser based systems and methods are known for enabling ophthalmological surgery on the external surface of the cornea in order to correct vision defects by the technique known as ablative photo decomposition of the cornea. In such systems and methods, the irradiated flux density and exposure time of the cornea to the ultraviolet laser radiation are so controlled as to provide a surface sculpting of the cornea to achieve a desired ultimate surface change in the cornea, all in order to correct an optical defect. Such systems and methods are disclosed in the following U.S. patents and patent applications, the disclosures of which are hereby incorporated by reference: U.S. Pat. No. 4,665,913 issued May 19, 1987 for "Method for Ophthalmological Surgery"; U.S. Pat. No. 4,669,466 issued Jun. 2, 1987 for "Method and Apparatus for Analysis and Correction of Abnormal Refractive Errors of the Eye"; U.S. Pat. No. 4,732,148, issued Mar. 22, 1988 for "Method for Performing Ophthalmic Laser Surgery"; U.S. Pat. No. 4,770,172 issued Sep. 13, 1988 for "Method of Laser-Sculpture of the Optically Used Portion of the Cornea"; U.S. Pat. No. 4,773,414 issued Sep. 27, 1988 for "Method of Laser-Sculpture of the Optically Used Portion of the Cornea"; U.S. patent application Ser. No. 109,812 filed Oct. 16, 1987 for "Laser Surgery Method and Apparatus"; and U.S. patent application Ser. No. 081,986 filed Aug. 5, 1987 for "Photorefractive Keratectomy". The art has now advanced to the stage at which self-contained laser based systems are sold as stand alone units to be installed in a surgeon's operatory or a hospital, as desired. Thus, hospitalization is not necessarily required in order to perform such ophthalmological surgery. Such systems typically include a p.c. (personal computer) type work station, having the usual elements (i.e., keyboard, video display terminal and microprocessor based computer with floppy and hard disk drives and internal memory), and a dedicated microprocessor based computer which interfaces with the p.c. work station and appropriate optical power sensors, motor drivers and control elements of the ultraviolet laser, whose output is delivered through an optical system to the eye of the patient. In use, after the patient has been accommodated on a surgery table or chair, the system is controlled by the operator (either the surgeon or the surgeon and an assistant) in order to prepare the system for the delivery of the radiation to the patient's eye at the appropriate power level and spatial location on the corneal surface. Patient data is typically entered, either manually via the p.c. work station keyboard or from a memory storage element (e.g., a floppy disk), and the system automatically calculates the beam delivery parameters and displays the resulting calculations on the video display terminal, with an optional hard-copy printout via a suitable printer. The laser is also prepared to deliver the appropriate radiation in accordance with the calculated beam delivery parameters, and the delivery system optics are likewise preconditioned. In some systems, a provision is made for permanently recording on a plastic card made of PMMA (polymethylmethacrylate) a spot image of the laser beam used in the surgical operation. This spot is recorded prior to the operation to ensure that the beam power is properly adjusted and to provide a permanent record of the beam used. PMMA is typically used due to the characteristic of this material of having a closely similar ablative photo decomposition response to that of the human corneal tissue. After the surgery has been performed, the resultant data is typically made part of a permanent record, which becomes part of the patient's file. Such systems and methods are presently emerging as the technique of choice for ophthalmological surgery to correct various vision defects in humans. However, as a relatively recent development this technique in general is still subject to close scrutiny and careful evaluation by the medical community as well as by certain regulatory agencies (e.g., the Food and Drug Administration in the United States of America). Although the p.c. work station provides some ability to collect pertinent information for the evaluation of system performance and to aid in tracking the efficacy of the surgical technique, as well as to provide quality control assistance to the manufacturer of the system, existing laser systems lack a simple effective control mechanism for this purpose. SUMMARY OF THE INVENTION The invention provides a simple control mechanism for monitoring the actual usage of ophthalmological laser surgery systems, which is relatively inexpensive to implement and highly reliable in tracking information relating to machine usage and patients' data relating to surgeries performed. In a first aspect of the invention, an ophthalmological laser surgery system is provided with a patient data card read/write device for controlling and monitoring the operation of the laser surgical system in conjunction with a precoded patient data card. The data card and read/write device interact in such a manner that the laser surgical system cannot be operated unless an authorized patient data card is inserted into the read/write device. Once the patient data card is recognized by the system as a legitimate and authorized card, the system is unlocked for normal operation. Preferably, during normal operation the beam delivery parameters calculated by the system, as well as other actual surgical operation data (such as the configuration of the delivery system optics, the duration and power of the laser irradiation of the patient's cornea, the coordinates of the projected laser beam, and the like) are recorded on the patient data card to form a permanent record independently of or parallel to the information stored in the p.c. work station. Also, a test spot of the actual laser beam can be permanently recorded onto the patient data card by directing the beam onto a preselected region of the data card to perform an ablation of that region. In another aspect, the invention comprises a patient data card having encoded therein several kinds of information for use in evaluating and controlling a laser based ophthalmological surgery system and surgeries performed therewith. A first type of information comprises an authorization code required by the surgery system for enablement to an operative state. Preferably, this first type of information includes a code unique to a specific laser surgery system so that a given patient data card can be used on one and only one machine. Further information stored on the card identifies all authorized surgeons, the patient, the patient's past history, the desired prescription or other identifying information regarding the permissible surgery to be performed on that patient, and preoperative diagnostic information for checking the laser system settings. The card may also contain downloadable software for controlling or altering the operation of the laser system. The card may also contain a photograph of the patient, one or more fingerprints of the patient, or a combination of this or other identifier information. In addition, the card preferably contains an ablation region capable of forming and retaining a physical laser ablation imprint of the intended laser treatment for future analysis and comparison. In use, the card is pre-coded by the system manufacturer or some other control agency, and issued for use with a specific system. If desired, the patient information may be intentionally left blank and provided by the surgeon or some other authorized person prior to the surgical operation. After the surgery has been performed, the actual data pertaining to the surgery is encoded onto the card for future use. Preferably, the data card is issued for a single surgery and is invalidated immediately thereafter, e.g., by permanently recording an invalidation character onto the card. The data stored on the card can be transferred from the card to any one of a number of interested parties. The surgeon, for example, may transfer the information from the card to a patient data file or some other master file maintained by the surgeon. This can be done at the data card read/write device and the p.c. work station at the site of the laser system. In addition, the information recorded in the patient data card can be transferred to the system manufacturer's files either from the surgeon's office using the p.c. work station and a modem, or directly from the patient data card. In the latter case, the card can be physically transferred to the manufacturer's office by either the surgeon or the patient, or the patient may visit one of a number of convenient sites having a compatible card reader device. For a fuller understanding of the nature and advantages of the invention, reference should be had to the ensuing detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of an ophthalmological laser surgery system incorporating the invention; and FIG. 2 is a plan view of a patient data card according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Turning now to the drawings, FIG. 1 illustrates a block diagram of an ophthalmological surgery system incorporating the invention. As seen in this Fig., a p.c. work station 10 is coupled to the single board computer 21 of a laser surgery unit 20 by means of a first bus connection 11. P.C. work station 10 and the subcomponents of laser surgery unit 20 are known components and preferably comprise the elements of the VISX TWENTY/TWENTY excimer laser system available from Visx, Incorporated of Sunnyvale, Calif. Thus, the laser surgery system 20 includes a plurality of sensors generally designated with reference numeral 22 which produce feedback signals from the moveable mechanical and optical components in the laser optical system, such as the elements driven by an iris motor 23, an image rotator 24, an astigmatism motor 25 and an astigmatism angle motor 26. The feedback signals from sensors 22 are provided via appropriate signal conductors to the single board computer 21, which is preferably an STD bus compatible single board computer using a type 8031 microprocessor. The single board computer 21 controls the operation of the motor drivers generally designated with reference numeral 27 for operating the elements 23-26. In addition, single board computer 21 controls the operation of the excimer laser 28, which is preferably an argon-fluorine laser with a 193 nanometer wavelength output designed to provide feedback stabilized fluence of 160 mJoules per cm 2 at the cornea of the patient's eye 30 via the delivery system optics generally designated with reference numeral 29. Other ancillary components of the laser surgery system 20 which are not necessary to an understanding of the invention, such as a high resolution microscope, a video monitor for the microscope, a patient eye retention system, an ablation effluent evacuator/filter, and the gas delivery system, have been omitted to avoid prolixity. Similarly, the keyboard, display, and conventional p.c. subsystem components (e.g., flexible and hard disk drives, memory boards and the like) have been omitted from the depiction of the p.c. work station 10. P.C. work station 10 is actively intercoupled with a patient data card writer/reader 40 designed to interact with an individual patient data card 42 schematically illustrated in FIG. 2. As seen in FIG. 2, the patient-data card 42 is similar to a credit card and has a first surface region 43 for carrying visually readable information, such as the name of the patient, the card supplier (e.g., laser surgery system manufacturer, health care provider or the like), the patient's name and any other information which is deemed desirable for visual presentation. Another region 44 is reserved for information identifying the authorized bearer or user of the card, such as a fingerprint or a photograph of the patient. An ablation region or target area 45 is provided for permanently recording the laser beam operating characteristics just prior to or after performance of a surgery. For this purpose, ablation region 45 may comprise an insert of a polymethylmethacrylate, which as noted above has close matching ablative photo decomposition characteristics to that of human corneal tissue. Alternatively, the entire card 42 may be fabricated of PMMA, or some other substance such as polycarbonate which has similar ablation characteristics to PMMA. The purpose of the ablation region 45 is to provide a permanent ablative photo decomposition record produced by the actual laser beam used in the surgery. Patient data card 42 is preferably an optical memory card of the type manufactured and marketed by Drexler Technology Corporation under the trademark LaserCard, which is a credit card sized optical data storage device capable of holding more than four megabytes of write once/read many (WORM) data. Similarly, the data card writer/reader 40 may be a known unit compatible with the Drexler optical memory card. If desired, a suitable magnetic memory card may be employed along with a compatible card writer/reader device 40. The patient data card 42 is initially provided with read only information optically encoded into the subsurface recording layers (not visible in FIG. 2). This information includes the serial number or other identifying characteristic of a specific laser surgery system 20 so that the data card 42 can only be used with a specific system 20. The purpose for this limitation is to provide controlled information relating to the amount of use of the system 20 and a match between the identity of the system 20 and the actual beam used during the eye surgery (the ablation record permanently formed in ablation region 45 of the data card 42). In addition, other qualifying data may be permanently recorded by the card producer, such as the personal identification number of the surgeon or surgeons (or other personnel) qualified to operate the specific system 20, the prescription of the patient to control the amount and type of laser surgery on a particular patient, the eye upon which surgery will be allowed (e.g., right eye only, left eye only or both, including any differences in prescription between the two eyes), and any other relevant and pertinent information deemed desirable for monitoring the specific patient and the specific system 20. In order to render the system 20 operative, an authorized data card 42 must be read by the writer/reader 40, and this information must then be presented to the p.c. work station 10, which functions as the master control for the system 20. Once an authorized card has been inserted and identified, the operation of the system 20 proceeds in a somewhat conventional fashion in that the beam delivery parameters are calculated in the p.c. work station 10 and transferred to the single board computer 21 for control of the various motors 23-26, the laser 28 and the delivery system optics 29. At some time during the surgery procedure, preferably just prior to the actual irradiation of the eye 30, the data card 42 may be installed in a fixture (not shown) in the output beam path of the laser 28 (i.e., within the delivery system optics 29 or at the output side thereof) and the laser 28 is pulsed at the surgical rate and power to form the permanent record of the laser beam in the ablation region 45. Thereafter, the surgery is performed and the post operation data is measured, calculated and stored in an appropriate memory location within the p.c. work station 10. Certain information may then be recorded onto the patient data card 42 by means of the data card writer/reader 40 so that the data card 42 obtains post operative information useful for monitoring purposes. For example, the date of the operation, the total length of the exposure of the corneal surface of the eye 30 to the laser beam 28, the pulse duration, the time between pulses, the exact coordinate settings of the laser beam radiation throughout the operation may all be recorded on the patient data card 42. This information is then available until destruction of the card for any informational purposes the surgeon, the patient, the health insurance company, the regulatory agency and the system manufacturer may require. In addition, if desired the card 42 may be permanently altered to prevent repeated use with specific surgery system 20 or any other system 20 as an added check on the operational use of a specific system 20. The patient data card 42 may contain program instructions required for the operation of the system 20. In such an embodiment, p.c. workstation 10 receives the necessary program instructions from the card 42 using a conventional software downloading operation at the beginning of system operation. At the conclusion of system operation, the program instructions resident in the p.c. workstation 10 are erased to prevent subsequent operation of system 20 without a fresh data card 42. As will now be apparent, laser surgery systems provided with the personal data card functioning as a control token offer an unparalleled degree of control over the use of the surgery system and afford a rigorous information gathering capability for quality control and monitoring studies. In particular, every single use of a given surgery system 20 can be accurately monitored by use of the patient data card 42, and the actual operating characteristics and optical parameters can be permanently stored in an independently verifiable manner for future study. Such a capability is particularly important for laser surgery systems still subject to regulatory control, as well as to fully approved laser surgery systems for which cumulative historical data is highly desirable. The added cost of the data card reader/writer 40 is nominal compared to the overall system, and the patient data card is no more inconvenient to carry and use than any conventional credit card. While the above provides a full and complete disclosure of the preferred embodiments of the invention, various modifications, alternate constructions and equivalents may be employed as desired. For example, while the invention has been described with specific reference to an optically encoded data card 42, data cards having read/write storage capability and using magnetic or semiconductor technology may be employed, as desired. In addition, other laser surgery systems than the VISX system noted above can be used to implement the invention. Therefore, the above description and illustrations should not be construed as limiting the invention, which is defined by the appended claims.

1a

CROSS-REFERENCE TO RELATED TOPICS [0001] This application claims priority by a U.S. Provisional Application Nos. 61/457,899, with a Filing Priority Date of Jun. 30, 2011, 61/741,249, with a Filing Priority Date of Jul. 16, 2012, & 61/957,502 with a Filing Priority Date of Jul. 5, 2013, and 61/997,878 with a Filing Priority date of Jun. 12, 2014. [0002] Assignee: Not applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT REFERENCE TO SEQUENCE LISTING IN A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISK APPENDIX [0003] Not applicable. BACKGROUND OF THE INVENTION [0004] The present invention generally relates to a decorative charm bracelet arrangement whereby the wearer provides immediate medical identification and information about a plurality of conditions affecting the wearer including specific personal data in the form of for example, name, age, next of kin, telephone numbers (both cell and land lines), parental email addresses, emergency contacts and primary physician's name address and telephone numbers. [0005] Existing prior art examples have taken the form of identification cards attached to utilitarian lanyards made from inexpensive, cheap materials such as cotton, nylon and combinations thereof in the form of ball or beaded chain suspended from a person's neck, pocket, or lapel, badge clips, and student's dormitory key chains. [0006] A few devices have been designed to meet similar needs. The devices shown for example, in U.S. Pat. No. 5,794,371—Camillery, U.S. Pat. No. 6,223,559—Coleman, U.S. Pat. No. 6,256,793—Arias et al, U.S. Pat. No. 6,263,702—Lo, U.S. Pat. No. 6,293,128—Leufray-Simms, and U.S. Pat. No. 7,257,967—Rheinstein, U.S. Pat. No. 7,323,998—Girvin et al, U.S. Pat. No. 7,849,619—Mosher Jr et al, U.S. Pat. No. 7,905,036 Howell, US 2003/0106336—Gaskill, US 2003/0150143—Hazard, US 2009/0113933—Hatem, and US 2011/0068926—Jong et al. [0007] Prior art devices such as those disclosed above have several disadvantages with respect to personalizing the means of identification in a manner that is both decorative and informative. [0008] The aforementioned prior art devices such as those disclosed above are adequate for the basic purposes for the specifically intended use, it is apparent that they are uniformly deficient with their capability to provide comprehensive, simple, efficient, and practical medical identification charm bracelet with respect to audible and visual identifications. [0009] To address the particular limitations in the prior art, the instant invention provides a novel arrangement for combining an ornamental adornment in the form of a bracelet, necklace, broach, that provides life saving information about the wearer to enable any bystander to alert medical authorities in the event that the wearer is involved in an accident, or a medical emergency. [0010] Therefore a comprehensive device was needed that would enable the wearer to provide medical information in a manner that will not embarrass or become cause the wearer to become uncomfortable when in the company of peers; this is considered to be of particular concern to minors and young adults. BRIEF SUMMARY OF THE INVENTION [0011] This invention allows the user to provide medical information in a readily retrievable manner by the use of attractive and decorative means in the form of wrist, ankle charm bracelets, necklaces, headbands, neckbands, ankle-bands, leg-bands, and garment accessories such as neckties, belts, and garters. [0012] In a further embodiment of the instant invention user information can be incorporated in children's and youth accoutrements such as, Back Packs, Purses by the attachment of identifying appliqués denoting for example, Disney, Nickelodeon, and sports team logos. [0013] The essence of the instant invention is to provide easy to use, versatile, simple of designs of medical information that is readily accessible, visually and audibly apparent and simple for the user to wear. [0014] The various disclosed embodiments of the instant invention have been developed to satisfy the aforementioned needs in an efficient and economically feasible and practical manner. In particular, the instant invention provides for the user/wearer to display as a charm or linked bracelet a Cartoon Character in a high gloss paint finish in the center of the bracelet, or necklace with the user/wearer personal identification printed on the back of the charm or linked bracelet Cartoon Character. In this manner, the user/wearer postal address, telephone/cell phone numbers of next of kin, etc., can be readily displayed. In addition specific sports team logos for participating sports organizations, such as NBA, WNBA, NFL, NHL, MLS can be depicted in the same manner. [0015] The Cartoon Characters in for example, from the Disney, Nickolodeon or similar children's media corporations cast of characters, can be changed with added links during the child's developmental stages and provide the child/user/wearer some measure of self identification, independence and self expression. In addition specific sports team logos for participating sports organizations, such as NBA, WNBA, NFL, NHL, MLS can be depicted in the same manner. [0016] A prime feature of the instant invention can be described in that for every purchase of bracelet, necklace, charm attachment, each child/user/wearer will be in receipt of an authenticated corporation card (from Disney, Nickolodeon or equal child media corporation) which will provide additional detail information that can be attached to the child's/user's/wearer's personal back-pack, purse, kit-pack etc. [0017] For added security to the child's/user's/wearer's well being, each bracelet, necklace or other personal adornment jewelry will be provided with a tamper resistant sturdy, closure clasp. [0018] For further added security to the child's/user's/wearer's well being on each linked bracelet, necklace or other personal jewelry adornment, an adornment will be included to provide the child's/user's/wearer's particular medical condition, allergies, or specific medical condition and engraved on each link of the bracelet, necklace or other similar personal adornment. [0019] In addition in further embodiments to the instant invention, for example, it can be arranged to incorporate a number of additional features and embodiments that enhance the wearer's capacity to relay important medical information to the public at large in an attractive, informative manner connecting with a variety of cognitive senses as described as follows: reusable or non-reusable identification device incorporating tamper resistant fastening for necklaces, bracelets. identification information incorporated in children's and youth accoutrements such as Back Packs and Purses denoting for example, Disney, Nickelodeon, and sports teams logos. medical identification information providing encoded biometric data such as fingerprints, retina scans, iris, blood, DNA, in the form of electronic chip data storage devices. the inclusion in the medical identification device of a bar-code that would contain additional medical and personal information about the user and wherein the bar-code, and Quick Response (QR) two dimensional bar codes are scanable to obtain additional health and personal information. means for providing biomedical monitoring functions using devices in contact with the user's skin whereby the user's state of health can be detected using electronic control circuits and data transmitting apparatus in the form of flexible electronic chips embedded in necklace or bracelet charms. use of RFID (Radio Frequency Identification) circuits embedded in necklace or bracelets charms whereby a transponder emits a wireless signal representative of medical information stored in the transponder and responsive to changes in the user's medical condition. BRIEF DESCRIPTION OF THE DRAWINGS [0026] Various features, aspects, and advantages of the present invention will become apparent with reference to the following FIGS. 1 to 19 accompanying this application. [0027] FIGS. 1 to 3 are examples of a bracelet or necklace design 10 comprising circular chain links, closure clasps and suspended charms attached to individual chain links for girls and for boys in for example but not limited to gold, platinum, or silver, elastic and hypo-allergic materials. [0028] FIG. 1 disclose examples of decorative charm characters in front view, and FIGS. 2 and 3 discloses bracelet, necklace side and end views respectively. [0029] FIGS. 4 and 5 are examples of bracelet and necklace design 10 embodiments incorporating a child's favorite Cartoon or Sports character on one side of centrally placed cartoon, sports figure or sports logo 16 and with medical information 18 on the reverse side. [0030] FIGS. 6 and 7 are examples of alternative bracelet and necklace link design 20 with charm link designs incorporating Cartoon or Sports character on one side of a centrally placed and with medical information on the reverse side and including specific attachment embodiments providing user allergy information 22 and electronic chip information 24 . In addition, links 21 and 23 provide for independent stand-alone power supplies in the form of dc. battery power, and solar cell power respectively. [0031] FIG. 8 provides an alternative bracelet or necklace link design 20 including an embodiment wherein an RFID or Infra Red device 26 is included. [0032] FIG. 9 provides alternative bracelet or necklace link design 20 including an embodiment for an USB computer portal 25 , and GPS positioning 28 attachment. [0033] FIG. 10 provides alternative bracelet or necklace link design 20 including an embodiment 30 for biomedical monitoring device. [0034] FIG. 11 provides alternative bracelet or necklace link design 20 including an embodiment 32 for an audible device means. [0035] FIG. 12 provides alternative bracelet or necklace link design 20 including an embodiment 34 with visual alarm means. [0036] FIG. 13 provides alternative bracelet and necklace link design 20 including an embodiment 36 attachments design with a biomedical monitoring device attachment feature with audible alarm means. [0037] FIG. 14 provides an alternative bracelet or necklace link design 20 including an embodiment 38 wherein medical information identification is includes with an electronic chip. [0038] FIG. 15 provides an alternative necklace or bracelet link design 20 including an embodiment 40 with a bar code data scan able for downloading user medical information in an attachment feature. [0039] FIG. 16 provides an alternative necklace or bracelet link design 20 including an embodiment 42 with a two dimensional Quick Response (QR) bar code data scan able for downloading user medical information in an attachment feature. [0040] FIG. 17 provides an alternative necklace or bracelet link design 20 including an embodiment 44 with a biomedical monitoring device attachment feature with visual indications. [0041] FIG. 18 Alternative necklace or bracelet link design 20 including an embodiment 46 wherein a combined visual and audible alarm is actuated in the event that the user exhibits abnormal medical conditions. [0042] FIG. 19 provides an example of children's backpack, kit-pack, or purse 48 with embodiments incorporating a child's favorite Cartoon or Sports character 16 on one side of attached to for example, a Zipper Tab and with medical information 18 on the reverse side. In addition, FIG. 19 also discloses any one or any combination of the additional embodiments 21 , 22 , 23 , 24 , 25 , 26 28 , 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 , 46 , attached for example, to a backpack, kit-pack or purse closure Zipper Tab. [0043] FIG. 20 discloses 50 the ‘Charm Symbol Purchase Authentication Certificate from Issuing Entity’ LIST OF REFERENCE NUMBERS FOR THE ELEMENTS IN THE DRAWINGS [0044] Examples of bracelet, necklace link designs 10 with Charm Figure attachments 12 and tamper resistant Necklace or Bracelet clasp closure clasp 14 . [0045] Necklace or bracelet link designs 10 with Cartoon Character or Sports Team logo or shapes in presentation formats including high gloss paint, etched outlines, neon paint format, hologram pattern format or equal clearly visible pictorial presentation formats, on the front side 16 with the child's/user's/wearer's personal identification 18 printed, etched, etched and filled with reflective substances such as fluorescent paint, hologram pictorial representations of selected figures, and engraving or other clearly visible indicia marking formats, on the reverse side. [0046] Alternative examples of bracelet, necklace link designs 10 , 20 with Charm Figure attachments 12 , Medical Alert symbols 52 , and tamper resistant Necklace or Bracelet water-tight closure clasp 14 incorporating a USB portal 25 . [0047] Necklace or bracelet link designs 20 with Cartoon Character or Sports Team logo or shapes in high gloss paint or equal pictorial presentation format on the front side 16 with the child's/user's/wearer's personal identification 18 printed on the reverse side. [0048] Necklace or bracelet link design 22 disclosing the user's specific allergy information. [0049] Alternative necklace or bracelet link design 20 with links providing independent stand alone power supplies in the form of 21 dc.battery power and 23 solar cell power. [0050] Alternative necklace or bracelet link design 20 including an embodiment 24 with an electronic chip attachment feature. [0051] Alternative necklace or bracelet link design 20 including an embodiment 25 with an USB computer terminal portal feature. [0052] Alternative necklace or bracelet link design 20 including an embodiment 26 with an RFID, antennae, or Infra Red attachment tag feature. [0053] Alternative necklace or bracelet link design 20 including an embodiment 28 with a GPS attachment feature. [0054] Alternative necklace or bracelet link design 20 including an embodiment 30 with a biomedical monitoring device attachment feature. [0055] Alternative necklace or bracelet link design 20 including an embodiment 32 with an audible device attachment feature. [0056] Alternative necklace or bracelet link design 20 including an embodiment 34 with a device attachment feature with visual alarm means. [0057] Alternative necklace or bracelet link design 20 including an embodiment with a biomedical monitoring device attachment feature 36 with audible alarm means. [0058] Alternative necklace or bracelet link design 20 including an embodiment 38 with an electronic chip embedded in an attachment feature. [0059] Examples of bracelet, necklace link designs 10 , and 20 including energy supply means in the form of dc battery supply 21 and solar cell power supply 23 for the purposes of powering design embodiments including items 24 , 25 , 26 , 28 , 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 , and 46 . [0060] Alternative necklace or bracelet link design 20 including an embodiment 40 with a bar code data scan able for downloading user medical information in an attachment feature. [0061] Alternative necklace or bracelet link design 20 with a two dimensional Quick Response (QR) bar code data scan 42 able for downloading user medical information in an attachment feature. [0062] Alternative necklace or bracelet link design 20 including an embodiment 44 with a biomedical monitoring device attachment feature with visual indications. [0063] Alternative necklace or bracelet link design 20 including an embodiment 46 wherein a combined visual and audible alarm is actuated in the event that the user exhibits abnormal medical conditions. [0064] Further example of the instant invention is incorporated in children's and youth accoutrements such as Back Packs, Kit-pack and Purses 48 , denoting for example, Disney, Nickelodeon and sports team logos with embodiments incorporating a child's favorite cartoon or sports character 16 on one side of centrally placed figure and with medical information 18 on the reverse side. [0065] For each purchase of the said charms 16 the organization owning, for example the Cartoon Character, or the Sports organization, will provide a card/certificate of authentication 50 providing additional personal information of the child/user/wearer. [0066] In yet a further embodiment of the instant invention, children's Back Packs and Purses 48 , can be provided with any additional attachments such as those described above in items 21 , 22 , 23 , 24 , 25 , 26 , 28 , 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 , and 46 . [0067] I yet a further feature of the instant invention a ‘Charm Symbol Purchase Authentication Certificate 50 is provided from the symbol issuing authority signifying that the symbol truly represents the an authentic version of the specific symbol. [0068] The instant invention is novel in that the ‘Charm Symbol Purchase Authentication Certificate 50 verifies the participation of the symbol issuing authority in the user's physical welfare program. DETAILED DESCRIPTION OF THE INVENTION [0069] The instant invention is novel in that it provides for a collection of physical charm designs 12 that can be easily attached to bracelets, necklaces 10 , 20 , and other personal adornments in combinations of charm designs and the means for monitoring changes in the physical condition of the user. [0070] In particular, the instant invention provides for the user/wearer to display as a charm or linked bracelet a cartoon character in a high gloss paint finish in the center of the bracelet, or necklace with the user/wearer personal identification printed on the back of the charm or linked bracelet cartoon character. [0071] In the instant invention, the user/wearer postal address, telephone/cell phone numbers of next of kin, etc., can be readily displayed. [0072] Further in the instant invention, specific sports team logos of participating sports organizations) which will provide additional detail information that can be attached to the child's/user's/wearer's personal back-pack, purse, kit-pack etc. [0073] The invention is comprised essentially of a variety of bracelet, necklace 10 , 12 , 20 , and other personal wear adornments in a range of designs that incorporate both attractive 16 and useful medical information 18 about the user that is readily accessible to members of the public in the event of a change in the medical condition of the user. [0074] In the instant invention, the cartoon characters 16 can for example, be derived from the Disney, Nickolodeon or similar children's media corporations cast of characters, can be changed with added links during the child's developmental stages and provide the child/user/wearer some measure of self identification, independence and self expression. [0075] In the instant invention, specific sports team logos of participating sports organizations) will provide additional detail information that can be attached to the child's/user's/wearer's personal 48 back-pack, purse, kit-pack etc. [0076] Similarly, in the instant invention, specific sports team logos of participating sports organizations) which will provide additional detail information that can be attached to the child's/user's/wearer's personal back-pack, purse, or kit-pack 48 . [0077] For each purchase of the said charms the organization owning the Cartoon Character will provide a card/certificate of authentication 50 providing additional personal information of the child/user/wearer. [0078] In yet a further embodiment of the instant invention, the necklace and bracelet designs, 10 , 20 , and children's back packs, purses or kit-packs 48 , can be provided with any additional attachments such as those described above in items 16 , 18 , 21 , 22 , 23 , 24 , 25 , 26 , 28 , 29 , 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 , and 46 as disclosed in the following: 1. A pictorial representation of the user's preference for a cartoon character or sports logo in a variety of formats including but not limited to enamel or fluorescent paint, etching, or hologram on the front side 16 , and with user specific medical information on the reverse side 18 . 2. A water tight bracelet or necklace closure clasp 14 with accommodation for a USB portal 29 . 3. An embodiment 22 disclosing for example, the user's specific allergy information. 4. Embodiments in the form of dc. battery power 21 and solar cell power 23 supplies for powering items including 24 , 26 , 28 , 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 and 46 . 5. An embodiment 24 with an electronic chip attachment feature for digitally transferring information relating to the user's medical information. 6. An embodiment 25 providing an USB computer terminal capability. 7. An embodiment 26 with an RFID, antennae or Infra Red tag attachment feature for transferring the user's medical information. 8. An embodiment 28 with a GPS attachment feature with the user's position information 9. An embodiment 30 with a biomedical monitoring device attachment feature. 10. An embodiment 32 with an audible device attachment feature. 11. An embodiment 34 with a device attachment feature with visual alarm means. 12. An embodiment with a biomedical monitoring device attachment feature 36 with audible alarm means. 13. An embodiment 38 with an electronic chip embedded in an attachment feature. 14. An embodiment 40 with a bar code data scan able for downloading user medical information in an attachment feature. 15. An embodiment providing a two dimensional Quick Response (QR) bar code data scan 42 able for downloading user medical information in an attachment feature. 16. An embodiment 44 with a biomedical monitoring device attachment feature with visual indications. 17. An embodiment 46 wherein a combined visual and audible alarm is actuated in the event that the user exhibits abnormal medical conditions. [0096] For each purchase of the said charms from participating organizations with distinctive logos including but not limited to, sports teams in the NBA, WNBA, NFL, NHL, MLS, the individual sports organization/team administrative contacts will provide a card/certificate of authentication providing additional personal information of the child/user/wearer; providing additional personal information of the child/user/wearer. [0097] The invention provides a vast variety of charm designs in a variety of shapes and sizes and a broad range of medical information means specifically relating to the user's medical conditions. The prime feature of the instant invention can be described in that for every purchase of bracelet, necklace, charm attachment, each child/user/wearer will be in receipt of an authenticated corporation card from a Cartoon Character (from Disney, Nickolodeon or equal child media corporation) and specific sports team logos of participating sports organizations) which will provide additional detail information that can be attached to the child's/user's/wearer's personal back-pack, purse, kit-pack etc. [0098] The instant invention discloses a medical information bracelet comprising: a one piece continuous member in material in for example, elastic, comprises hypoallergenic elastomer and the elastomer is coated with a hypoallergenic material; wherein said bracelet further includes an individual's medical information affixed to said bracelet wherein said medical information comprises one of said individual's illnesses, medical history, condition, required medications, allergies, a personal physician or doctor, emergency contact information, or insurance information and wherein said information is affixed by stitching, embroidery, iron-on, coloring, screen printing, sewing on a badge, or a combination thereof. [0099] The instant invention provides for a bracelet or necklace closure water tight seal clasp 14 selected from a range of designs including but not limited to spring clasps, hinge clasps, hooks, spiral rings, jump rings, or toggle clasps. [0100] The instant invention further discloses that the closure clasp 14 or link 25 , can incorporate a USB portal 29 capable of storing digital data and accessing from the user's internet account relating to the user's medical history information. [0101] In addition, the instant invention provides the user to exhibit medical information in a readily retrievable manner by the use of attractive and decorative means in the form of a variety of other personal adornments such as wrist, ankle charm bracelets, headbands, neckbands, ankle-bands, leg-bands, and garment accessories such as neckties, belts, and garters. [0102] The instant invention disclose a computer-implemented method for providing a medical alert system, providing a database for storing medical information for an individual user and associating the stored medical information with a barcode of the individual user and sending to a computing device over an internet network. [0103] The instant invention discloses a system for identifying a person by means of attaching an identification apparatus to a person, the attachment means comprising a circuit configured to receive and store biometric information about the person when the circuit is in an active state, such that the circuit is configured to store new biometric information received from an external device after returning to the active state. [0104] The invention provides a novel arrangement for combining an ornamental adornment in the form of a bracelet, necklace, broach, that provides life saving information about the wearer to enable any bystander, or member of the public to alert medical authorities, medical first responders in the event that the user/wearer is involved in an accident, or a medical emergency rendering the user/wearer incapacitated. [0105] The instant invention provides an easy to use, versatile, simple array of designs of medical information that is readily accessible, audibly 32 and visually 34 and apparent and simple for the user to wear without in any way drawing attention to the presentation of the medical information means and avoiding causing any embarrassment to the user. [0106] The invention can readily incorporate a number of features that enhance the wearer's capacity to relay important medical information to the public at large in an attractive, informative manner connecting with a variety of cognitive senses. [0107] The invention is capable of incorporating reusable or non-reusable identification device incorporating tamper resistant fastening for necklaces, bracelets. The materials used in making these items include the form of sterling silver 14 K and other similar types of metals. [0108] The instant invention is capable of providing identification information incorporated in children's and youth accoutrements such as Back Packs and Purses, denoting Disney, Nickelodeon and sports team logos. [0109] The invention is capable of incorporating medical identification information providing encoded biometric data such as fingerprints, retina scans, iris, blood, DNA, in the form of electronic chip 38 data storage devices. [0110] The invention in a further embodiment can provide medical identification devices with bar-code information that would contain additional medical and personal information about the user and wherein the bar-codes 40 , 42 , are scanable to obtain additional health and personal information. [0111] The invention in yet a further embodiment can provide biomedical monitoring functions using devices in contact with the user's skin whereby the user's state of health can be detected using electronic control circuits 28 and data transmitting apparatus in the form of flexible electronic chips embedded in necklace or bracelet charms. [0112] The invention in yet a further embodiment can incorporate the use of RFID (Radio Frequency Identification) circuits 26 embedded in necklace or bracelets charms whereby by means of a transponder can emit a wireless signal representative of medical information stored in the said transponder and responsive to changes in the user's medical condition. [0113] The individual components of the instant invention are capable of being constructed in a variety of materials, in the form of rare and valuable metals including gold, silver, sterling silver, platinum and various alloys thereof. [0114] Further the individual components of the instant invention are also capable of being constructed in a variety of other materials, in the form of corrosion resistant metals including stainless steel, nickel and chromium alloys, titanium, copper, bronze, and alloys thereof. [0115] Further the individual components of the instant invention are also capable of being constructed in a variety of other non metallic materials, in the form of for example, plastics, hardened plastic, fiberglass, and combinations thereof. [0116] In yet a further invention design embodiment, the individual components of the bracelet, or necklace can be provided in a variety of metallic and non-metallic materials comprising elastomer hypoallergenic coatings. [0117] It will be evident that the plurality of embodiments of the instant invention disclosed herewith have a multiplicity of applications including but not limited to combining a vast range of physically attractive charms with a broad range of means for relaying medical information relevant to the user's stable medical condition and importantly providing means for indicating important changes in the user's medical condition. [0118] It will be evident that the instant invention Medical ID bracelets are different from other Medical ID bracelets because they have designed them with medical professionals/patients in mind based on experience from a Registered Nurse with ER experience. [0119] Specifically when working in the Emergency Room, the patients are received both conscious and unconscious and it is necessary to work expeditiously to save lives, and when patients are transported to the hospital by ambulance, and arrive before their loved ones and relatives, pertinent information such as allergies to medications remain unknown. [0120] It is evident from insights by contacts with numerous patients with health issues/allergies, that not wearing Medical ID bracelets results from the fact that visually Medical ID bracelets are ugly and unfashionable. [0121] Recognizing these visual factors, the instant invention has created Medical ID bracelets where Medical needs information meets current Fashion trends, resulting in Medical ID bracelets that will be informative to Medical Staff and provide acceptable trendy fashion styles for both children, adolescents and adults. [0122] It is well known medically, that nurses, and doctors can be visually informed by being able to assess medical conditions/allergies on unconscious patients, and with a quick glance at the lifesaving information in the form of a Medical ID bracelet, or necklace, proper treatment can be rendered accurately and promptly. [0123] It is well understood that Fashion visual trends have a significant influence on children, adolescents, and adults in their lives, and an opportunity to select images, such as, Nickelodeon/Disney Characters and other media or sports team logos characters that they admire, in the form of Medical ID will be attractive and enhance self-esteem. [0124] It is also well known that Children with chronic illnesses and allergies acquire self-esteem issues resulting from being the subject of bullying and feeling isolated and embarrassed about their condition. Therefore, Children with such medical conditions and allergies can be perceived inferior and different by their peers. [0125] In the instant invention therefore, a Medical ID charm bracelet would allow Children and adolescents to display hanging embodiments from the bracelet displaying, for example, their favorite Nickelodeon/Disney Character, and at the same time disclosing preexisting medical conditions. In this manner, Children and adolescents would no longer feel ashamed to wear a medical ID bracelet and instead would have a sense of pride in showing their preference for favorite media or sports team logos and specific characters or players. [0126] In addition, the instant invention by devising Medical ID link bracelets, or bracelets that are designed both for Children, adolescents and also adults, can afford adults the same opportunity to wear their favorite Sports Teams while at the same time disclosing pertinent medical information and thereby provide practically universal application benefits. [0127] It will further be understood from the foregoing description that various modifications and changes can be readily incorporated in the preferred embodiments of the instant invention without departing from the essential inventive concept and from its true spirit. [0128] This specification description and the accompanying drawings are intended for the purposes of illustration only and should not be construed in a limiting sense.

1a

RELATED APPLICATIONS [0001] This application is a United States National Stage Application claiming priority under 35 U.S.C. 371 from International Patent Application No. PCT/US09/32015 filed on Jan. 26, 2009, which claims the benefit of priority from U.S. Provisional Application No. 61/023,566, filed on Jan. 24, 2008, the entire contents of which are herein incorporated by reference. TECHNICAL FIELD OF THE INVENTION [0002] This invention relates to the field of interstitial lung diseases and treatments related thereto. BACKGROUND OF THE INVENTION [0003] Interstitial Lung Disease (ILD) is a general term that includes a variety of chronic lung disorders. When a person has ILD, the lung is affected in three ways. First, the lung tissue is damaged in some known or unknown way. Second, the walls of the air sacs in the lung become inflamed. Finally, scarring (or fibrosis) begins in the interstitium (or tissue between the air sacs), and the lung becomes stiff. [0004] Breathlessness during exercise can be one of the first symptoms of these diseases. A dry cough also may be present. These are common symptoms that many people ignore. Someone with these symptoms may wait until they feel quite ill before going to the doctor. People with different types of ILD may have the same kind of symptoms but their symptoms may vary in severity. Their chest X-rays may look alike. Further testing is usually recommended to identify the specific type of ILD a person has. Some ILDs have known causes and some (idiopathic) have unknown causes. [0005] ILD is named after the interstitium because this is the tissue affected by fibrosis (scarring). ILD is sometimes also known as “interstitial pulmonary fibrosis.” The terms interstitial lung disease, pulmonary fibrosis and interstitial pulmonary fibrosis are often used to describe the same condition and will be used interchangeably herein. [0006] The course of these diseases is unpredictable. If they progress, the lung tissue thickens and becomes stiff. The work of breathing then becomes more difficult and demanding. Some of the diseases improve with medication if treated when inflammation occurs. Some people may need oxygen therapy as part of their treatment. The diseases may run a gradual course or a rapid course. People with ILD may notice variations in symptoms—from very mild to moderate to very severe. Their condition may remain the same for long periods of time or it may change quickly. [0007] While the progress and symptoms of these diseases may vary from person to person, there is one common link between the many forms of ILD. They all begin with an inflammation. The inflammation may affect different parts of the lung, including the following: the walls of the bronchioles (bronchiolitis); the walls and air spaces of the alveoli (alveolitis); the small blood vessels (vasculitis). [0008] Inflammation of these parts of the lung may heal or may lead to permanent scarring of the lung tissue. When scarring of the lung tissue takes place, the condition is called pulmonary fibrosis. [0009] Fibrosis, or scarring of the lung tissue, results in permanent loss of that tissue's ability to transport oxygen. The level of disability that a person experiences depends on the amount of scarring of the tissue. This is because the air sacs, as well as the lung tissue between and surrounding the air sacs, and the lung capillaries, are destroyed by the formation of scar tissue. [0010] Several causes of pulmonary fibrosis are known, including the following: [0011] Infections: These include viral infections such as cytomegalovirus (a particular problem for people with compromised immune systems); bacterial infections, including pneumonia; fungal infections such as histoplasmosis; and parasitic infections. [0012] Occupation and environmental factors: Long-term exposure to a number of toxins or pollutants can lead to serious lung damage. Workers who routinely inhale silica dust (silicosis), asbestos fibers (asbestosis) or hard metal dust are especially at risk of debilitating lung disease. So are people exposed to certain chemical fumes—sulfuric acid, for example—and ammonia or chlorine gases. But chronic exposure to a wide range of substances, many of them organic, also can damage your lungs. Among these are grain dust, sugar cane, and bird and animal droppings. Other substances, such as moldy hay, can be a problem when they cause a hypersensitivity reaction in the lungs (hypersensitivity pneumonitis). Even bacterial or fungal overgrowth in poorly maintained humidifiers and hot tubs can cause lung damage. [0013] Radiation: A small percentage of people who receive radiation therapy for lung or breast cancer show signs of lung damage months (or sometimes years) after the initial treatment. The severity of the damage depends on how much of the lung is exposed to radiation, the total amount of radiation administered, whether chemotherapy also is used and the presence of underlying lung disease. [0014] Drugs: Nearly 50 drugs can damage the interstitium of the lungs, especially chemotherapy drugs, medications used to treat heart arrhythmias and other cardiovascular problems, certain psychiatric medications, and some antibiotics. [0015] Other medical conditions: ILD can occur with other disorders. Often, those conditions don't directly attack the lungs, but instead involve systemic processes that affect tissue throughout the body. Among these are connective tissue disorders and hematological diseases, including systemic lupus erythematosis, rheumatoid arthritis, dermatomyositis, polymyositis, Sjogren's syndrome and sarcoidosis. [0016] Idiopathic pulmonary fibrosis: Although doctors can determine why some people develop ILD, in most cases the cause isn't known. Disorders without a known cause are considered a subset of ILD and are grouped together under the label idiopathic pulmonary fibrosis or idiopathic ILD. Although the idiopathic diseases have certain features in common, each also has unique characteristics. [0017] Usual interstitial pneumonitis is the most prevalent of the idiopathic ILDs. Accounting for more than half of all cases, it's so common that the terms “usual interstitial pneumonitis” and “idiopathic pulmonary fibrosis” are often used interchangeably. Because usual interstitial pneumonitis develops in patches, some areas of the lungs are normal, others are inflamed and still others are marked by scar tissue. The disease affects twice as many men as women and usually develops between the ages of 40 and 70. [0018] Although the names are nearly identical, pneumonitis is not the same as pneumonia. Pneumonitis is lung inflammation without infection, whereas pneumonia is lung inflammation that results from infection. In addition, pneumonia is generally limited to one or two areas of the lungs, but pneumonitis involves all five lobes—two in the left lung and three in the right. [0019] Other, less common types of idiopathic pulmonary fibrosis include nonspecific interstitial pneumonitis, bronchiolitis obliterans with organizing pneumonia (BOOP), respiratory bronchiolitis-associated ILD, desquamative interstitial pneumonitis, lymphocytic interstitial pneumonitis, acute interstitial pneumonitis and bronchopulmonary dysplasia. [0020] Shortness of breath is the main symptom of idiopathic pulmonary fibrosis. Since this is a symptom of many types of lung disease, making the correct diagnosis may be difficult. The shortness of breath may first appear during exercise. The condition then may progress to the point where any exertion is impossible. [0021] Other symptoms may include a dry cough (without sputum). When the disease is severe and prolonged, heart failure with swelling of the legs may occur. [0022] A very careful patient history is an important tool for diagnosis of idiopathic pulmonary fibrosis. The history will include environmental and occupational factors, hobbies, legal and illegal drug use, arthritis, and risk factors for diseases that affect the immune system. A physical examination, chest X-ray, pulmonary function tests, and blood tests are important. [0023] Bronchioalveolar lavage (BAL), a test which permits removal and examination of cells from the lower respiratory tract, may be used to diagnose idiopathic pulmonary fibrosis. This test helps identify inflammation in lung tissue, and also helps exclude infections and malignancies (cancer) as a cause of a patient's symptoms. The test is done during bronchoscopy, a special examination of the lung. [0024] A lung biopsy can also be performed, either during bronchoscopy or as a surgical procedure that removes a sample of lung tissue for your doctor to study. This procedure is usually required for diagnosis of idiopathic pulmonary fibrosis. [0025] Other diagnostic tests for idiopathic pulmonary fibrosis include: blood tests, pulmonary function tests, chest x-ray and CT scan, to name a few. [0026] There are several different treatment regimens for use in ILD and the related conditions, including the following: [0027] Lung transplantation: This may be an option for younger people with severe forms of ILD who aren't likely to benefit from other treatment options. In order to be considered for a transplant, you must agree to quit smoking if you smoke, be healthy enough to undergo surgery and post-transplant treatments, be willing and able to follow the medical program outlined by the rehabilitation and transplant team, and have the patience and emotional strength and support to undergo the wait for a donor organ. The last is particularly important because donor organs are in short supply. In general, single-lung transplants are more successful in people with ILD than double-lung transplants are. And although many people who receive lung transplants enjoy a good quality of life, the survival rate is lower than it is for other types of transplants. Additionally, there is a quality of life issue with respect to the increased susceptibility to infection, high blood pressure, diabetes and cancer due to the life-long administration of the anti-rejection drugs. [0028] Oxygen therapy: Although oxygen cannot stop lung damage, it can make breathing and exercise easier, prevent or lessen complications from low blood oxygen levels, and improve sleep and sense of well-being for afflicted patients. It can also reduce blood pressure on the right side of the heart. Children with ILD are especially likely to need oxygen therapy. [0029] Cytotoxic drugs: Azathioprine, which is normally used to prevent organ rejection after a transplant, and the anti-cancer drug cyclophosphamide may be used to treat ILD by suppressing inflammation. The drugs are prescribed when corticosteroids fail to improve symptoms or, increasingly, as a first-line treatment in combination with corticosteroids. Cytotoxic drugs can cause severe side effects, including reduced production of red blood cells, skin cancer and lymphoma. [0030] Antifibrotics: These drugs are used to help reduce the development of scar tissue. In clinical studies, these drugs have shown promise for slowing the progression of lung damage without suppressing the immune system, but real-world results have been disappointing. [0031] Systemic corticosteroid drugs: Although systemic anti-inflammatory drugs, such as prednisone or methyl prednisolone, are the initial treatment of choice, they help only about one in five people with ILD. Those most likely to benefit have a non-idiopathic disorder and reversible changes in their lungs. Systemic corticosteroids seldom improve lung function in people with idiopathic pulmonary fibrosis. If benefits are shown, they are usually temporary in nature. In general, corticosteroid administration lasts for several months until symptoms improve, at which point the administration is tapered. Upon return of the symptoms, further steroid therapy or an immunosuppressive drug such as azathioprine may be recommended. Taken for long periods of time or in large doses, systemic corticosteroids can cause a number of side effects, including glaucoma, bone loss, high blood sugar levels leading to diabetes, poor wound healing and increased susceptibility to infection. Corticosteroids may be administered to treat the inflammation present in some people with IPF. The success of this treatment for many forms of pulmonary fibrosis is variable and is still being researched. Other drugs are occasionally added when it is clear that the corticosteroids are not effective in reversing the disease. Some doctors may use corticosteroids in combination with other drugs when the diagnosis is first established. Which drug treatment plan is effective and how long to use the drugs is the focus of current research. [0032] Pulmonary complications after allogeneic hematopoietic cell transplantation (HCT) remain a major cause of morbidity and mortality. Among the estimated 50,000 to 60,000 hematopoietic cell transplantations performed each year (www.ibmtr.org), approximately 30% to 60% of the transplant recipients will experience a pulmonary complication (Cordonnier C et al., Cancer, 1986; 58:1047-1054; Jules-Elysee K et al., Am Rev Respir, Dis 1992; 146:485-491. A need exists in the field to develop a therapeutic alternative to combat the progression of ILD and the related conditions. SUMMARY OF THE INVENTION [0033] The present invention provides a novel approach for treating ILD by administering an oral dosage form of beclomethasone dipropionate (BDP) and exposing the pulmonary circulation to a metabolite of BDP, the metabolite being 17-beclomethasone monopropionate (17-BMP). [0034] In one aspect, the present invention provides a method for delivering a corticosteroid or a metabolite thereof to a subject's pulmonary artery by administering to the subject an oral dosage of the corticosteroid. In one embodiment, the corticosteroid is BDP and the metabolite is 17-BMP. Alternatively, the present invention includes any corticosteroid administration used for the alleviation of inflammatory systems, as well as its metabolite. [0035] In another aspect, the present invention provides a pharmaceutical composition for treating damage resulting from ILD comprising 17-BMP. [0036] In another aspect, the present invention provides a method for preventing, ameliorating and/or treating damage resulting from ILD, the method comprising delivering to a subject's pulmonary artery a metabolite of an orally administered corticosteroid. [0037] In yet another aspect, this invention provides methods which increase the delivery of medicaments to lung tissue. [0038] The present invention is based on the discovery that topically active corticosteroids administered orally resulted in a 4-8 fold increase in the quantity of active drug delivered to the lungs over the amount of active drug delivered via an inhalation route. Side effects usually attributed to systemic corticosteroids are therefore minimized by delivery of active drug to the pulmonary artery and by rapid clearance of such drug from the systemic circulation, while controlling the tissue inflammation within the lung. BRIEF DESCRIPTION OF THE DRAWINGS [0039] FIG. 1 depicts cumulative incidence of non-infectious pulmonary complications after treatment randomization. Vertical dashed line indicates Day 200 after treatment randomization. Prior to Day 200 after treatment randomization, no cases of non-infectious pulmonary complications occurred among the BDP-treated patients. [0040] FIG. 2 depicts cumulative incidence of pulmonary infections after treatment randomization. Vertical dashed line indicates Day 200 after treatment randomization. There were no statistically significant differences in the risk of pulmonary infections between the two treatment groups at Day 200 or one year after randomization. DETAILED DESCRIPTION OF THE INVENTION Definitions [0041] The term “an effective amount” as used herein refers to a quantity of topically active corticosteroid which will, upon single or multiple dose oral administration to the patient, be effective in the prophylaxis, amelioration and/or treatment of damage to the structures of the lung caused by or related to inflammation. [0042] The term “preventing, ameliorating and/or treating” as used herein refers to a reduction or elimination of subsequent damage compared with the damage which would have occurred if the oral corticosteroid were not administered; and in the case where the oral corticosteroid is administered after the damage has occurred, a reduction or elimination of such damage. [0043] The term “damage” as used herein refers to any alteration in normal structure or function. [0044] By “lining” is meant any biological material which covers a surface or lines a cavity or the like and which performs protective, screening and/or other functions. [0045] By “topically active” or “locally active”, is meant the compound has its principal pharmacological action through tissue near the site where the drug is present. In the case of a topically active corticosteroid (TAC), there is limited systemic exposure either by limited absorption, first pass metabolism by the liver and/or gut, enterohepatic recirculation, protein binding, or rapid elimination from the systemic circulation, and any combination thereof. [0046] By “systemic circulation” it is meant that portion of the circulation which is anatomically distal to the pulmonary circulation, or the circulation resulting from left ventricular outflow into the aorta, arteries, arterioles, capillaries, and venous system, in which a steady-state level of the drug in the circulation has been achieved. [0047] By a “pharmaceutically acceptable carrier or excipient” is meant a carrier or excipient which is compatible with the other ingredients of the composition and not injurious to the patient. [0048] The term “effective amount” means that amount of a drug or pharmaceutical agent that will elicit the biological or medical response of a tissue, system, animal or human that is being sought by a researcher or clinician. [0049] The term “therapeutically effective amount” means any amount which, as compared to a corresponding subject who has not received such amount, results in improved treatment, healing, prevention, or amelioration of a disease or disorder, or a decrease in the rate of advancement of a disease or disorder, and also includes amounts effective to enhance normal physiological function. [0050] The TACs described in the practice of the present invention can be administered in buccal and sublingual dosage forms as tablets, capsules (each including timed release and sustained release formulations), pills, powders, granules, elixirs, tinctures, suspensions, syrups and emulsions. [0051] The dosage regimen utilizing the compounds of the present invention is selected in accordance with a variety of factors including type, species, age, weight, sex and medical condition of the patient; the severity of the condition to be treated; the route of administration; the renal and hepatic function of the patient; and the particular compound or salt thereof employed. An ordinarily skilled physician can readily determine and prescribe the effective amount of the drug required to combat the enteritis and/or mucositis condition. [0052] Oral dosages in the practice of the present invention, when used for the indicated effects, will range between about 0.01 to about 100 mg/kg of body weight per day of TAC, and particularly about 0.1 to 10 mg/kg of body weight per day. Oral dosage units will generally be administered in the range of from 0.1 to about 250 mg and more preferably from about 1 to about 16 mg. The daily dosage or a 70 kg human will range from 1 mg to 16 mg. [0053] The dosing scheme of the present invention is predicated on the notion that none of the parent TAC delivered (ie. BDP) can be found in the systemic circulation, but that 20-40% of the metabolite (ie. 17-BMP) reaches the systemic circulation. It is thus believed that increasing the parent compound dosing will not result in a burden to the systemic circulation, but will increase the active metabolite in the pulmonary circulation. [0054] In the methods of the present invention, the compounds herein described in detail can form the active ingredient and are typically administered in admixture with suitable pharmaceutical diluents, excipients or carriers (collectively referred to herein as “carrier” materials) suitably selected with respect to the intended form of administration, that is, oral tablets, capsules, elixirs, syrups and the like, and consistent with conventional pharmaceutical practices. [0055] For instance, for oral administration in the form of a tablet or capsule, the active drug component can be combined with an oral, non-toxic pharmaceutically acceptable inert carrier such as ethanol, glycerol, water and the like. Powders are prepared by committing the compound to a suitable fine size and mixing with a similarly comminuted pharmaceutical carrier such as an edible carbohydrate, as, for example, starch or mannitol. Flavoring, preservative, dispersing and coloring agent can also be present. [0056] Capsules are made by preparing a powder mixture as described above, and filling formed gelatin sheaths. Glidants and lubricants such as colloidal silica, talc, magnesium stearate, calcium stearate or solid polyethylene glycol can be added to the powder mixture before the filling operation. A disintegrating or solubilizing agent such as agar-agar, calcium carbonate or sodium carbonate can also be added to improve the availability of the medicament when the capsule is ingested. [0057] In addition to the TAC, acceptable carriers and/or diluents may be employed and are familiar to those skilled in the art. Formulations in the form of pills, capsules, microspheres, granules or tablets may contain, in addition to one or more TACs, diluents, dispersing and surface-active agents, binders and lubricants. One skilled in the art may further formulate the TAC in an appropriate manner, and in accordance with accepted practices, such as those disclosed in Remington's Pharmaceutical Sciences, Gennaro, Ed., Mack Publishing Co., Easton, Pa., 1990 (incorporated herein by reference). Moreover, when desired or necessary, suitable binders, lubricants, disintegrating agents and coloring agents can also be incorporated into the mixture. Suitable binders include starch, gelatin, natural sugars such as glucose or beta-lactose, corn sweeteners, natural and synthetic gums such as acacia, tragacanth, or sodium alginate, carboxymethylcellulose, polyethylene glycol, waxes and the like. Lubricants used in these dosage forms include sodium oleate, sodium stearate, magnesium stearate, sodium, benzoate, sodium acetate, sodium chloride and the like. Disintegrators include, without limitation, starch, methyl cellulose, agar, bentonite, xanthan gum and the like. Tablets are formulated, for example, by preparing a powder mixture, granulating or slugging, adding a lubricant and disintegrant and pressing into tablets. A powder mixture is prepared by mixing the compound, suitably comminuted, with a diluent or base as described above, and optionally, with a binder such as carboxymethylcellulose, an aliginate, gelatin, or polyvinyl pyrrolidone, a solution retardant such as paraffin, a resorption accelerator such as a quate nary salt and/or an absorption agent such as bentonite, kaolin or dicalcium phosphate. The powder mixture can be granulated by wetting with a binder such as symp, starch paste, acadia mucilage or solutions of cellulosic or polymeric materials and forcing through a screen. As an alternative to granulating, the powder mixture can be run through the tablet machine and the result is imperfectly formed slugs broken into granules. The granules can be lubricated to prevent sticking to the tablet forming dies by means of the addition of stearic acid, a stearate salt, talc or mineral oil. The lubricated mixture is then compressed into tablets. The compounds of the present invention can also be combined with free flowing inert carrier and compressed into tablets directly without going through the granulating or slugging steps. A clear or opaque protective coating consisting of a sealing coat of shellac, a coating of sugar or polymeric material and a polish coating of wax can be provided. Dyestuffs can be added to these coatings to distinguish different unit dosages. [0058] Oral fluids such as solution syrups and elixirs can be prepared in dosage unit form so that a given quantity contains a predetermined amount of the compound. Syrups can be prepared by dissolving the compound in a suitably flavored aqueous solution, while elixirs are prepared through the use of a non-toxic alcoholic vehicle. Suspensions can be formulated by dispersing the compound in a non-toxic vehicle. Solubilizers and emulsifiers such as ethoxylated isostearyl alcohols and polyoxy ethylene sorbitol ethers, preservatives, flavor additive such as peppermint oil or natural sweeteners or saccharin or other artificial sweeteners, and the like can also be added. [0059] Where appropriate, dosage unit formulations for oral administration can be microencapsulated. The formulation can also be prepared to prolong or sustain the release as for example by coating or embedding particulate material in polymers, wax or the like. [0060] The compounds for use according to the present invention can also be administered in the form of liposome delivery, systems, such as small unilamellar vesicles, large unilamellar vesicles and multilamellar vesicles. Liposomes can be formed from a variety of phospholipids, such as cholesterol, stearylamine or phosphatidylcholines. [0061] The compounds may also be co-administered with soluble polymers as excipients or drug carriers. Such polymers can include polyvinyl-pyrrolidone, pyran copolymer, poly-hydroxypropylmethacryl-amidephenol, poly-hydroxyethyl-aspartamidephenol, or poly-ethyleneoxidepolylysine substituted with palmitoyl residues. Furthermore, the compounds may be coupled to a class of biodegradable polymers useful in achieving controlled release of a drug, for example, polylactic acid, polepsilon caprolactone, polyhydroxy butyric acid, polyorthoesters, polyacetals, polydihydropyrans, polycyanoacrylates and cross-linked or amphipathic block copolymers of hydrogels. [0062] Alternatively, a measured amount of the compound is placed in a vial and the vial and its contents are sterilized and sealed. An accompanying vial or vehicle can be provided for mixing prior to administration. Non-toxic salts and salt solutions can be added to render the injection isotonic. Stabilizers, preservations and emulsifiers can also be added. [0063] The preferred drugs for use in the composition of the present invention is BDP and its metabolite, 17-BMP. However, the invention is not restricted thereto, and relates to any corticosteroid drug which is locally active and delivered as either the parent drug or an active metabolite to the pulmonary artery for effective treatment of inflammatory interstitial lung diseases. Representative TACs include, but are not limited to, beclomethasone 17,21-dipropionate, alclometasone dipropionate, budesonide, 228 budesonide, 22R budesonide, beclomethasone-17-monopropionate, clobetasol propionate, diflorasone diacetate, flunisolide, flurandrenolide, fluticasone propionate, halobetasol propionate, halcinonide, mometasone furoate, and triamcinolone acetonide. Suitable TACs useful in the practice of this invention are any that have the following characteristics: rapid first-pass metabolism in the intestine and liver, low systemic bioavailability, high topical activity, delivery of active drug to the pulmonary artery and rapid excretion (see, e.g., Thiesen et al., Alimentary Pharmacology & Therapeutics 10:487-496, 1996) (incorporated herein by reference). [0064] The preferred drug is BDP, on account of its very high topical anti-inflammatory activity, and generation within the intestinal tract of a potent metabolite (17-BMP) that is delivered to the pulmonary artery. BDP can therefore be used effectively in very small doses, in the compositions of this invention, and will not enter the systemic circulation to any significant extent. Additionally, the metabolite of BDP, 17-BMP, may be accessed through oral administration of the parent compound. Other corticosteroid drugs (such as budesonide) are also of use. BDP is a compound that is available from a number of commercial sources, such as Schering-Plough Corporation (Kenilworth, N.J.) in bulk crystalline form, and has the following structure (i.e., beclomethasone 17,21-dipropionate): [0000] [0065] Patients receive a therapeutically acceptable amount of a TAC by oral administration. Suitable capsules or pills generally contain from 0.1 mg to 8 mg TAC, and typically about 1 mg TAC, plus optional fillers, such as lactose, and may be coated with a variety of materials, such as cellulose acetate phthalate. Such an amount may be readily determined by one skilled in the art by well-known dose-response investigations, and will generally range from 0.1 mg/day to 8 mg/day, and more typically range from mg/day to 8 mg/day, or higher used in this particular indication. [0066] It will be appreciated that, although specific embodiments of this invention have been described herein for purpose of illustration, various modifications may be made without departing from the spirit and scope of the invention. [0067] BDP is a glucocorticoid that when taken orally is metabolized in the intestinal lumen and mucosa to a significantly more potent glucocorticoid metabolite, 17-BMP. Studies in normal human volunteers have demonstrated that none of the parent compound (BDP) can be found in the systemic circulation, but that 20-40% of the oral drug that reaches the systemic circulation does so as 17-BMP (Daley-Yates et al). 17-BMP is then rapidly cleared from the circulation. The route by which 17-BMP reaches the circulation is as follows: following formation in the intestine, 17-BMP passes through the portal circulation to the liver, then to the hepatic vein, then to the right atrium and right ventricle, then to the pulmonary artery, the pulmonary vein, then the left atrium, left ventricle, and aorta. Exposure of the pulmonary circulation to the highly potent immunosuppressive glucocorticoid, 17-BMP, is the basis for the idea that inflammatory and fibroinflammatory diseases of the lungs, particularly the diseases that involve the interstitium of the lung, might be effectively and safely treated by oral delivery of the glucocorticoid pro-drug BDP. While inhaled BDP is effective in treating reactive airway diseases that have an inflammatory basis, for example, asthma and chronic obstructive pulmonary disease with chronic bronchitis, inhaled formulations of BDP deliver relatively little 17-BMP to the interstitial space, as much of the inhaled drug reaches the bronchi, smaller airways, and alveoli. [0068] Prednisone therapy is effective in treatment of reactive airway disease and some types of ILD, but is limited by systemic toxicity. Topically active, inhaled BDP was developed to allow delivery of glucocorticoid to the lung so that the systemic toxicity of prednisone could be avoided. [0069] If a person with a pulmonary disorder were given BDP via inhalation, the total daily dose of BDP would be a maximum of 400 .micro.grams (0.4 mg). While there is metabolism of BDP to 17-BMP in the lungs, the maximum daily amount of 17-BMP that reaches the lungs would be limited to 0.4 mg. In contrast, if a daily dose of 8 mg. oral BDP were given, and if 20-40% of that dose was delivered to the pulmonary artery as 17-BMP, the total daily dose of 17-BMP delivered to the lungs would be 1.6 to 3.2 mg, a 4- to 8-fold increase in the amount of drug delivered to the lungs over the inhalation route. [0070] Two multicenter, randomized, placebo-controlled, double-blind trials have been conducted to examine whether oral beclomethasone dipropionate (BDP) is an effective therapy for treatment of gastrointestinal graft-versus-host disease (GVHD) (McDonald G B et al., Gastroenterology, 1996; 115:28-35; Hockenbery D M et al., Blood, 2007; 109:4557-4563). The results of these studies indicate that oral BDP is effective for treating gastrointestinal GVHD, allows rapid taper and less use of systemic corticosteroid therapy, and results in a 45% reduction in mortality risk at one year post-randomization. In addition to these benefits, the most recent trial revealed that BDP treatment was also associated with fewer cytomegalovirus reactivations (28% versus 39%), fungal infections, (7% versus 14%), and multiple bacteremic episodes (none versus 9%) (Hockenbery D M et al., Blood, 2007; 109:4557-4563). [0071] Of interest to the pulmonary community was the observation that during the 80-day study period, 12/67 (18%) patients on the placebo arm had developed noninfectious pulmonary infiltrative disorders, compared to 0/62 patients in the BDP treatment arm (17). Based upon this initial observation, it was believed that oral BDP may be effective in preserving lung function and preventing the development of early noninfectious pulmonary complications after allogeneic HCT. To test this hypothesis, there was a retrospective review of medical records and a prospective collection of pulmonary function test (PFT) results from all patients who participated in these two randomized trials. [0072] These results represent the first report in the literature of randomized trial data demonstrating a treatment strategy that may be not only protective of lung function after HCT, but useful in the prevention of the almost uniformly fatal noninfectious pulmonary complications that occur in the early post-HCT period. There was a statistically significant preservation of pulmonary diffusing capacity and fewer episodes of non-infectious pulmonary complications in patients randomized to receive oral BDP, compared to placebo. Although the primary objective in each of the two randomized, placebo-controlled trials of oral BDP was not to assess pulmonary outcomes, these findings are consistent with the mortality results of the trials suggesting more favorable outcome in the group randomized to BDP. These trials assessed the ability of this topically active glucocorticoid to control the signs and symptoms of gastrointestinal GVHD while minimizing systemic prednisone exposure. In both trials, the frequency of GVHD treatment failure was significantly reduced at the end of the treatment period and after follow-up among patients randomized to BDP, compared to placebo. These results are also consistent with what is known about the pathophysiology of idiopathic lung injury in the aftermath of allogeneic HCT and the pharmacology of oral BDP and its potent metabolite, 17-BMP. [0073] The reported incidence of IPS in the first 120 days after allogeneic HCT is 3 to 15%, with a lower incidence reported in association with the use of reduced intensity conditioning regimens. Respiratory failure is generally common and usually rapid in onset, with mortality uniformly high, ranging from GO % to greater than 95% for patients requiring mechanical ventilation. Although a few clinical risk factors have been consistently identified in previous studies, including conditioning with total body irradiation, acute GVHD, and older recipient age, accumulating evidence from murine models of lung injury after allogeneic HCT strongly suggest that inflammation plays a significant role in the pathogenesis of IPS. Some of these murine studies have established a causal role for TNF-α in the development of IPS, where administration of a TNF-α binding protein (rhTNFR:Fc) reduces the progression of lung injury during the four to six week period after HCT. Other studies have also suggested that lipopolysaccharide (LPS), which often gains access to systemic circulation early in the post-transplantation period by translocating across gut mucosa damaged by conditioning regimens and acute GVHD, may result in a significant inflammatory cytokine milieu in the lung that results in lung injury (Cooke K R et al., J Clin Invest, 1998; 102:1882-1891). Collectively, these data provide strong evidence that overwhelming inflammation within the lungs likely plays a significant role in the pathogenesis of early noninfectious pulmonary complications after HCT. These studies indicate that a sequence of events involving chemokine-driven recruitment of inflammatory and immune-effector cells to the lung, release of oxidants and proinflammatory cytokines, and, in the case of allogeneic transplantation, a second wave of injury mediated by alloreactive T lymphocytes, may lead to the development of IPS. [0074] The formulations of oral BDP used in the randomized trials described here included a gastric-release pill for distribution of BDP to the stomach and upper small intestine, and an enteric-coated pill for distribution to the distal small intestine and colon. Presence of 17-BMP in the blood from the right heart, as demonstrated by our data, suggests that 17-BMP, a product of gastrointestinal mucosal hydrolysis of BDP, was likely absorbed in the gastrointestinal tract and entered the right heart via portal venous circulation. In the HCT situation, we speculate that steady-state delivery of 17-BMP to the pulmonary circulation and ultimately the interstitial space prior to the onset of clinically detectable disease was responsible for reducing pulmonary inflammation, reflected by the preservation of pulmonary diffusing capacity and by the absence of noninfectious pulmonary infiltrates within the first 200 days after randomization. [0075] Consideration of oral BDP as a preemptive agent for these noninfectious pulmonary complications may have several advantages. Although BDP itself is a relatively weak immunosuppressive glucocorticoid, its active metabolite 17-BMP, is a highly potent glucocorticoid. In a human skin vasoconstriction model, where the degree of blanching (vasoconstriction) was interpreted as indicating anti-inflammatory activity, 17-BMP was 3.6-times more potent than triamcinolone-16,17-acetonide, the active ingredient in Azmacort inhalation aerosol (Kos Pharmaceuticals) and 450-times more potent than dexamethasone (Harris D M et al., J Steroid Biochem, 1975; 6:711-716). [0076] 17-BMP is also much more potent in terms of glucocorticoid receptor-α activity. In competition binding assays, where the affinity value for dexamethasone was arbitrarily set at 100 and affinity values of the other corticosteroids were calculated based on their reduction of specific binding of radiolabeled dexamethasone, 17-BMP's binding affinity was approximately 13-times as potent as dexamethasone (relative binding affinities were BDP: 43, 17-BMP: 1345) (Wurthwein G et al., Biopharm Drug Dispos, 1990; 11:381-394). Finally, the relative bioavailability of BDP and its metabolites is much lower in comparison to more commonly used corticosteroids. In a bioavailability study of oral BDP, where BDP was given orally and intravenously to 12 healthy subjects, no BDP was detectable in the plasma following oral administration. However, the total oral bioavailability of the active metabolite 17-BMP was 21-41%(unpublished data). Systemic exposure to 17-BMP is limited by its protein binding and clearance, such that oral BDP 2 mg would give systemic exposure equivalent to a dosing schedule of oral prednisone of 2.5 mg or less than 1 mg of intravenous dexamethasone. EXAMPLES Example I Preservation of Pulmonary Diffusing Capacity with Oral Beclomethasone Dipropionate [0077] Patients with biopsy-proven acute gastrointestinal GVHD received an induction course of prednisone (1 mg/kg/day for 10 days) plus either oral BDP pills (8 mg/day in four divided doses, half as a gastric-release formulation and half as an enteric-coated formulation) or placebo. Patients whose symptoms were controlled at study day ten continued on study drug while the prednisone dose was rapidly tapered. Patients whose symptoms required additional prednisone were considered treatment failures. Study drug was discontinued on the day of treatment failure. The duration of treatment with study drug was 30 days with a 10-day follow-up period in the first trial and 50 days with a 30-day follow-up period in the second trial. Pulmonary Function Testing [0078] Pulmonary function assessments included forced vital capacity (FVC), one-second forced expiratory volume (FEV1), total lung capacity (TLC), and carbon monoxide diffusion capacity (DL CO ), which was adjusted for hemoglobin level at the time PFTs were obtained. All PFT values were expressed as a percent of the predicted value calculated according to published equations (Crapo R O et al., Am Rev Respir Dis, 1981; 123:659-664; Crapo R O et al., Am Rev Respir Dis, 1981; 123:185-189). Pre-transplantation and Day 80 PFTs were obtained, regardless of the presence or absence of symptoms. After discharge, patients were encouraged to return at one year after transplantation, at which time another PFT was obtained. For purposes of the current study, PFTs performed between days 60 and 100 were considered as valid for the Day 80 PFT and tests performed between days 265 and 465 as valid for the one-year PFT. Change in lung function was assessed by comparing PFT parameters performed prior to start of conditioning to those obtained post-transplantation at Day 80 and one year. Analysis of change in lung function was done on an intent-to-treat basis, by randomization assignment to oral BDP or placebo, with maintenance of the study blind. [0079] Sixty patients had been randomized to oral BDP and the same number to placebo. Serial PFTs at day 80 were available from 44 and 50 patients on placebo and BDP, respectively. Significantly fewer patients randomized to BDP (55%) had deterioration of diffusing capacity by transplant day 80, compared to placebo (79%), p=0.02. No such differences were noted in other PFT parameters (see Table 1). In the analysis of change in PFTs from baseline to Day 80, eight patients who did not meet the minimum five-day criterion of treatment with study drug prior to their Day 80 PFT were not included (five in placebo group, three in BDP group). The median time to randomization was 33.5 days after HCT (range, 19-105) for the Phase 2 study and 31 days (range, 16-89) for the Phase 3 study. Several patients were missing baseline, Day 80, or one-year PFT as indicated by the total number of patients contributing to the appropriate analyses summarized Tables 1 and 2. Overall, the majority of the patients had normal pulmonary function prior to transplantation, defined as a percent of the normal predicted value≧80% [FVC 94/114 (82%); FEV1 88/114 (77%); TLC 105/113 (93%); DL CO 84/114 (74%)]. [0000] TABLE 1 Proportion of patients whose PFTs decreased from pre- HCT baseline to transplant day 80 and magnitude of changes, by randomization assignment (chi square test). PFT parameter Placebo BDP p-value FEV 1 N (%)* 21/44 (48) 25/50 (50) 0.83 Mean change (range) −1.38 (−25, +19) −0.05 (−22, +34) 0.48 FVC N (%)* 24/44 (55) 25/50 (50) 0.66 Mean change (range) −1.85 (−20, +16) +0.34 (−30, +35) 0.26 TLC N (%)* 25/42 (60) 29/50 (58) 0.88 Mean change (range) −1.67 (−20, +23) +1.41 (−25, +57) 0.23 DLCO N (%)* 33/42 (79%) 27/49 (55) 0.02 Mean change (range) −7.95 (−40, +23) +0.57 (−74, +115) 0.08 FVC = forced vital capacity, FEV 1 = one second forced expiratory volume, TLC = total lung capacity, DLCO = dffusion capacity of carbon monoxide *N represents proportion of patients who experienced a decrease in that parameter [0000] TABLE 2 Characteristics of BDP and placebo treated patients Characteristic Placebo (N = 60) BDP (N = 60) Median age (range) 47 (12-66) 40 (7-67) Recipient:donor sex M:M 17 24 M:F 11 12 F:F 12 9 F:M 20 15 Disease CML 13 15 AML 16 19 MDS 17 3 ALL 8 8 NHL 2 8 Other 4 7 Donor type Unrelated 24 20 Related matched 31 32 Related mismatched 3 7 Conditioning regimen TBI-based myeloablative 28 31 Non-TBI-based myeloablative 28 18 Nonmyeloablative 4 11 Randomized study Phase II 29 31 Phase III 31 29 Pulmonary function pretransplant * FVC (n = 58, 56) 95.1 93.7 FEV 1 (n = 58, 56) 89.9 90.4 TLC (n = 57, 56) 98.6 95.7 DLCO (n = 58, 56) 90.9 83.6 Pulmonary function at Day 80 * FVC (n = 49, 56) 93.0 93.8 FEV 1 (n = 49, 56) 89.2 90.3 TLC (n = 48, 55) 96.7 96.9 DLCO (n = 47, 54) 81.2 86.0 pulmonary function at one year * FVC (n = 29, 33) 94.0 89.4 FEV 1 (n = 29, 33) 88.5 85.9 TLC (n = 28, 33) 98.9 95.7 DLCO (n = 27, 33) 74.4 78.1 M = male; F = female; CML = chronic myeloid leukemia; AML = acute myeloid leukemia; MDS = myelodysplastic syndrome; ALL = acutelymphocytic leukemia; NHL = non-Hodgkins lymphoma; TBI = total body irradiation, FVC = forced vital capacity, FEV 1 = one second forced expiratory volume, TLC = total lung capacity, DLCO = dffusion capacity of carbon monoxide * Numbers represent the mean of the percent of predicted normal values [0080] Changes in pulmonary function from pre-transplantation to Day 80 after transplantation are summarized in Table 1. The proportion of BDP- and placebo-treated patients who experienced a decrease (of any magnitude) of their pulmonary function from pretransplantation to Day 80 after transplantation was similar for FVC, FEV1, and TLC, with no statistically significant differences. However, there was a statistically significant difference in the proportion of patients who experienced a decrease of the DL CO . Among placebo treated patients, 33 of 42 (79%) patients experienced a decrease of the DL CO from pre-transplantation to Day 80 after transplantation, compared to 27 of 49 (55%) BDP-treated patients (p=0.02). The mean decrease among placebo-treated patients was 7.95% (range −40% to +23%), while the mean change from baseline to Day 80 was actually increased 0.57% for BDP-treated patients (range −74% to +115%) (p=0.08). [0081] Additional analysis of PFTs obtained at one year after transplantation did not reveal any statistically significant associations of treatment with loss of pulmonary function. However, the decrease from baseline to one year in DL CO was larger in the placebo group compared to the BDP group (placebo: mean decrease of 15.27% among 27 patients with data; BDP: mean decrease of 7.67% among 32 patients with data; p=0.11). In the BDP group, four noninfectious events occurred after Day 200 ( FIG. 1 ; COP/BOOP on Day 207, IPS on Day 212, bronchiolitis obliterans syndrome on Day 244, DAH on Day 269). The COP/BOOP and DAH cases occurred after a myeloablative conditioning regimen, the IPS and bronchiolitis obliterans syndrome cases occurred after a reduced-intensity conditioning regimen. In the placebo group, a case of bronchiolitis obliterans syndrome in a patient conditioned with a myeloablative regimen was diagnosed on Day 311 after randomization. When all data from the first year after randomization were considered, the risk of developing a noninfectious complication remained lower among BDP-treated patients, but this did not reach statistical significance (HR=0.70, 95% confidence interval [CI] 0.19-2.57, p=0.58). The overall risk of developing a pulmonary infection by one year was lower for the BDP group, although this was not statistically significant (HR=0.67 (0.27-1.66, p=0.38)). [0082] Among 60 placebo-treated patients, four noninfectious complications occurred within the first 200 days after randomization ( FIG. 1 ). These cases were COP/BOOP (Day 39) and IPS (Day 69, 148, 168). All of these cases occurred after a myeloablative conditioning regimen. Among 60 BDP-treated patients, there were no cases of noninfectious pulmonary complications during the first 200 days after randomization ( FIG. 1 ). When considered as a time-to-event endpoint, the risk of developing a noninfectious complication within the first 200 days after randomization was reduced among BDP-treated patients, (hazard ratio [HR]=0, p=0.04; p=0.06 with the exact log-rank test). [0083] These data suggest that oral BDP may have a protective effect on early decline in pulmonary diffusing capacity, which commonly occurs by Day 80 after transplant because of interstitial lung injury. We hypothesize that preservation of diffusing capacity was due to delivery of the potent immunosuppressive metabolite 17-BMP to the lungs via GI mucosa, portal vein, and pulmonary artery. Example II Categorization of Pulmonary Disease after Hematopoietic Cell Transplantation [0084] While blinded to randomization assignment, investigators reviewed all patients' pulmonary radiologic records accumulated from the time of randomization to one year after transplantation. The medical records of all patients with abnormal pulmonary radiological findings were reviewed to determine whether the pulmonary disease was a clinically significant noninfectious or infectious syndrome. Clinically significant noninfectious pulmonary syndromes included idiopathic pneumonia syndrome (IPS), defined as widespread alveolar injury in the absence of active lower respiratory tract infection after HCT (Freudenberger T D et al., Blood, 2003; 102:3822-3828, diffuse alveolar hemorrhage (DAH), defined as IPS with bronchioalveolar lavage showing progressively bloodier return, or biopsy-proven cryptogenic organizing pneumonia (COP) otherwise known as bronchiolitis obliterans organizing pneumonia (BOOP). Clinically significant pulmonary infection required microbiologic documentation of an infectious agent in the respiratory tract via bronchoscopy or resolution of pulmonary abnormalities after empirical antibiotic therapy with no addition of immunosuppressive agents. [0085] The causes of pulmonary infections are summarized in Table 3. Among 60 placebo-treated patients, 11 cases of pulmonary infection occurred after randomization during the first year, five (45%) of which occurred within the first 200 days after randomization ( FIG. 2 ). Among 60 BDP-treated patients, 8 cases of pulmonary infection occurred during the first year after randomization, 6 (75%) of which occurred during the first 200 days after randomization ( FIG. 2 ). When considered as a time-to-event endpoint, the risk of developing a pulmonary infection was not statistically significantly different between BDP and placebo (HR=1.21 (0.37-3.96, p=0.75)). [0000] TABLE 3 Causes of pulmonary infection according to treatment group Placebo Oral BDP Day post- Day post- Cause of infection randomization Cause of infection randomization Fungal, nonspecific 41 Legionella spp. 27 Aspergillus fumigatus 59 Polymicrobial bacteria 31 Unknown cause 125 Pseudomonas aeruginosa 48 Aspergillus spp, 142 Candida glabrata 83 Unknown cause 143 Unknown cause 85 Pneumocystis jiroveci 209 Unknown cause 104 Aspergillus spp, 216 Parainfluenza and 210 Aspergillus spp. Unknown cause 219 Klebsiella pneumoniae 293 Aspergillus terreus 270 Candida spp. 275 Streptococcus hominis 373 Example III Measurement Of 17-Beclomethasone Monopropionate (17-BMP) in Blood from the Right Atrium [0086] Four FHCRC patients enrolled in the Phase 3 randomized study had participated in a sub-analysis of BDP pharmacokinetics. At study Day 50, blood was drawn from the right atrium via an indwelling Hickman catheter at frequent intervals after a morning dose of oral BDP 2 mg (1 mg each in gastric-release and enteric-coated tablets). Blood samples were collected over EDTA, plasma was collected after centrifugation at 4° C., and aliquots were frozen at −20° C. until analysis for BDP and 17-BMP using high-pressure liquid chromatography and mass spectroscopy (MDS Pharma Services, Montreal, Canada). Pharmacokinetic parameters were calculated using WinNonlin v.2.1 (Pharsight Corp, Palo Alto Calif.). Plasma concentration-time data were plotted and non-compartmental parameters were calculated using the linear trapezoidal rule. Estimates for half-lives were obtained using regression analysis by specifying an appropriate range of time points for the most linear portions of the log concentration-linear time data. [0087] Peak concentrations of 17-BMP in right atrial blood were achieved at a median of 1.5 hours after oral dosing of BDP 2 mg on the morning of study Day 50. The median C max , was 1738 pg/mL (range 632-3701). Median steady state exposure to 17-BMP was 5347 pg·hr/mL (range 3273-5201) as estimated by AUC 0-4 hr . The median half-life of 17-BMP was 6.3 hours (range 3.1-6.8). No BDP was detected in right atrial blood.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application claims benefit to U.S. Provisional Application Ser. No. 61/335,961, filed Jan. 14, 2010, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein. BACKGROUND Spinal fusion is a procedure that involves joining two or more adjacent vertebrae with a bone fixation device to restrict movement of the vertebra with respect to one another. Spinal fixation devices are used in spine surgery to align, stabilize and/or fix a desired relationship between adjacent vertebral bodies. Such devices typically include a spinal fixation rod, such as, for example, a relatively rigid fixation rod or a dynamic or flexible spinal fixation rod, etc. (collectively referred to herein as a spinal fixation rod), that is coupled to adjacent vertebrae by attaching the spinal fixation rod to various spinal fixation elements, such as, for example, hooks, bolts, wires, screws, such as pedicle screws, and the like. Surgeons may commonly choose to install multiple spinal fixation elements, as well as multiple spinal fixation rods, to treat a given spinal disorder. Conventional surgical techniques for spinal fusion have involved the use of multiple instruments that sometimes require the use of more than one hand to operate. Thus, multiple surgeons often manipulate the instruments used during a spinal fusion surgery. Furthermore, conventional surgical techniques included long incisions that are associated with long and painful recovery times. Recently, minimally invasive surgical procedures for performing spinal fusion have been developed that generally provide access to and perform corrective surgery at a surgical site while imparting reduced trauma to the patient anatomy. SUMMARY In accordance with one embodiment, a surgical instrument includes a driver and an actuator. The driver is configured to apply a torque to a locking cap of a spinal fixation device, so as to lock the locking cap against a spinal fixation rod. The driver defines a proximal end and a distal end opposite the proximal end. The actuator defines a distal end that is configured to fit over the spinal fixation rod, and a proximal end opposite the distal end. The actuator includes a body that defines a recess sized to receive the driver such that the driver extends through the actuator and is rotatable with respect to the actuator. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing summary, as well as the following detailed description of the preferred embodiments of the application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the surgical instruments and methods of the present application, there is shown in the drawings preferred embodiments. It should be understood, however, that the application is not limited to the specific embodiments and methods disclosed, and reference is made to the claims for that purpose. In the drawings: FIG. 1A is a rear elevation view of a portion of a spinal region of a human spine, illustrating three adjacent vertebrae separated by respective intervertebral spaces; FIG. 1B is a rear elevation view of the portion of the spinal region illustrated in FIG. 1A , whereby a pair of spinal fixation assemblies attached to the vertebrae after a spinal fusion surgery has been performed, the spinal fixation assembly including spinal fixation rods and spinal fixation devices; FIG. 2 is a perspective view of a spinal fixation device of the type illustrated in FIG. 1B ; FIG. 3 is a perspective view of a bone anchor manipulation instrument constructed in accordance with one embodiment including a torque assembly and an actuator; FIG. 4 is a perspective view of the torque assembly illustrated in FIG. 3 ; FIG. 5A is a perspective view of the actuator illustrated in FIG. 3 , including a distal body portion, a proximal body portion and an intermediate body portion; FIG. 5B is a top plan view of the intermediate body portion of the actuator illustrated in FIG. 5A ; FIG. 6 is a perspective view of the bone anchor manipulation instrument illustrated in FIG. 3 , shown operably coupled to a pair of spinal fixation devices; FIG. 7A is a perspective view of an anchor delivery instrument constructed in accordance with one embodiment including a handle and a guide; FIG. 7B is a perspective view of an anchor delivery assembly including the anchor delivery instrument illustrated in FIG. 7A and a trocar inserted into the guide of the anchor delivery instrument; FIG. 8 is a top plan view of the guide illustrated in FIG. 7A ; FIG. 9A is a schematic radio image of the guide illustrated in FIG. 8 , shown in a desired orientation; FIG. 9B is a schematic radio image of the guide illustrated in FIG. 8 , shown in an undesired orientation; FIG. 10 is a rear elevation view of adjacent vertebrae and intervertebral spaces showing the placement of a pedicle fiducial marker as an intra-operative reference point and a stable mount for various surgical instruments; FIG. 11A is a side elevation view of a fiducial marker illustrated as a spinal fixation device of the type illustrated in FIG. 2 ; FIG. 11B is a side elevation view of a fiducial marker illustrated as a bone anchor of the spinal fixation device of the type illustrated in FIG. 11A ; FIG. 11C is a side elevation view of a fiducial marker constructed in accordance with another embodiment; FIG. 11D is a top plan view of the fiducial marker illustrated in FIG. 11C ; FIG. 11E is a side elevation view of a fiducial marker constructed in accordance with another embodiment; FIG. 11F is a top plan view of the fiducial marker illustrated in FIG. 11E ; FIG. 11G is a side elevation view of a fiducial marker constructed in accordance with another embodiment; FIG. 11H is a top plan view of the fiducial marker illustrated in FIG. 11G ; FIG. 11I is a side elevation view of a fiducial marker constructed in accordance with another embodiment; and FIG. 11J is a top plan view of the fiducial marker illustrated in FIG. 11I . DETAILED DESCRIPTION Certain terminology is used in the following description for convenience only and is not limiting. The words “right”, “left”, “lower” and “upper” designate directions in the drawings to which reference is made. The words “proximally” and “distally” refer to directions toward and away from, respectively, the surgeon using the surgical instrument. The words, “anterior”, “posterior”, “superior”, “inferior” and related words and/or phrases designate preferred positions and orientations in the human body to which reference is made and are not meant to be limiting. The terminology includes the above-listed words, derivatives thereof and words of similar import. Referring to FIG. 1A , a spinal region 1 of the human spine includes a plurality of adjacent vertebrae 2 arranged along a vertical spinal column 3 . Adjacent vertebrae 2 are separated by respective intervertebral disc spaces 4 that can retain a vertebral disc 5 . As illustrated, the spinal region 1 includes a superior vertebra 2 a disposed above an inferior vertebra 2 b and separated from the inferior vertebra 2 b by a respective intervertebral disc space 5 a . It should be appreciated that a discectomy can be performed on one or more intervertebral disc spaces 4 as desired that remove the vertebral disc 5 so as to reveal an intervertebral disc space 5 a whereby the vertebral disc 5 has been removed. An artificial disc can be implanted in the intervertebral disc space 5 a . Alternatively or additionally, the adjacent vertebrae 2 that define the intervertebral disc space can be fused. For instance, referring to FIG. 1B , a surgical assembly 41 includes a spinal fixation assembly 10 that is configured to fuse or otherwise attach adjacent vertebrae 2 together. The spinal fixation assembly 10 , and components thereof, can be constructed generally as described in U.S. patent application Ser. No. 12/669,224, filed Jul. 21, 2008, published as U.S. Publication No. 2010/0198272, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein. In accordance with the illustrated embodiment, the spinal fixation assembly 10 can includes a plurality of spinal fixation devices 11 , for instance at least a pair of spinal fixation devices 11 , and a spinal fixation rod 12 configured to be coupled to the spinal fixation devices 11 . Accordingly, the spinal fixation rod 12 spans across at least one intervertebral disc space 4 . The spinal fixation devices 11 are implanted into respective vertebrae 2 , for instance into the pedicles of the vertebrae 2 . The spinal fixation rod 12 extends through the spinal fixation devices 11 so as to operatively couple the respective vertebrae 2 . Referring to FIG. 2 , the spinal fixation assembly 10 includes a plurality of spinal fixation devices 11 connected by a spinal fixation rod 12 that spans between the spinal fixation devices 11 . Each spinal fixation device 11 can generally include a bone anchor 13 , which can be a bone screw such as a pedicle screw, a bone anchor seat 17 and a locking cap 19 . The bone anchor 13 is received within the bone anchor seat 17 , such that the bone anchor seat 17 is coupled to the proximal end of the bone anchor 13 , and the distal end of the bone anchor 13 is configured to be driven into the corresponding underlying vertebra 2 . The bone anchor 13 can include a threaded shaft 60 that extends along a central axis 62 , such that any suitable driver can apply a torsional force or torque to the bone anchor, thereby rotating the bone anchor 13 so as to cause the shaft 60 to be driven into the underlying vertebra 2 . The bone anchor 13 can be inserted through the bone anchor seat 17 and subsequently driven into the underlying vertebra 2 , or can be driven into the underlying vertebra 2 and the bone anchor seat 17 can be subsequently popped downward onto the head of the bone anchor 13 . The bone anchor 13 can be rotated relative to the bone anchor seat 17 prior to locking the locking cap 19 in the bone anchor seat 17 . The bone anchor seat 17 includes a first bearing surface 34 that is configured to receive the spinal fixation rod 12 , and the locking cap 19 includes a second bearing surface 35 that is configured to secure the anchor seat 17 to the spinal fixation rod 12 , such that the spinal fixation rod 12 is captured between the bearing surfaces 34 and 35 when the locking cap 19 is tightened to the bone anchor seat 17 . Once the bone anchor 13 is implanted into the underlying vertebra 2 and attached to the bone anchor seat 17 , the spinal fixation rod 12 can be received against the first bearing surface 34 . For instance, in accordance with the illustrated embodiment, the locking cap 19 defines external threads 61 that mate with internal threads of the bone anchor seat 17 . The locking cap 19 further includes a recess 36 that is configured to receive a driving instrument that is configured to apply a torsional force or torque to the locking cap 19 . Accordingly, the locking cap 19 can be actuated, such as rotated or screwed, between a first unlocked configuration and a second locked configuration whereby the spinal fixation rod 12 is captured between the bearing surfaces 34 and 35 . When the locking cap 19 is in the unlocked configuration, the spinal fixation rod 12 can move with respect to the spinal fixation devices 11 , and the bone anchors 13 can rotate relative to the respective bone anchor seat 17 . When the locking cap 19 is in the locked configuration, such that the first bearing surface 34 and the second bearing surface 35 bear tightly against the spinal fixation rod 12 , the spinal fixation rod 12 is unable to move with respect to the spinal fixation device 11 . Furthermore, the locking cap 19 delivers a force to the bone anchor 13 that prevents the bone anchor 13 from rotating relative to the bone anchor seat 17 . Unless otherwise specified, the spinal fixation assembly 10 and its components can be made from any suitable biocompatible material such as titanium, titanium alloys such as titanium-aluminum-niobium alloy (TAN), implant-grade 316L stainless steel, poly-ether-ether-ketone (PEEK) or any suitable alternative implant-grade material. The spinal fixation devices 11 are each implanted into a corresponding plurality of underlying vertebra 2 disposed in a spinal region 1 . While the spinal fixation rod 12 is illustrated as having a length sufficient to join four spinal fixation devices 11 , it should be appreciated that the spinal fixation rod 12 can have any length suitable for attachment to any desired number of spinal fixation devices 11 configured to attach to any corresponding number of underlying vertebrae 2 . The spinal fixation rod 12 can extend substantially straight between a pair of opposing terminal ends 15 a and 15 b , and a middle portion 16 disposed between the terminal ends 15 a and 15 b , thereby defining a profile 14 that is substantially straight. While the profile 14 is substantially straight as illustrated, it should be appreciated that the spinal fixation rod 12 could be constructed as having a curved profile. For instance the middle portion 16 could be disposed posterior with respect to the terminal ends 15 a and 15 b when the spinal fixation devices 11 are implanted into the vertebrae 2 , such that the spinal fixation rod 12 is concave with respect to the spinal column 3 , though it should be appreciated that the spinal fixation rod 12 could also be curved when implanted such that the middle portion 16 is disposed anteriorly with respect to the terminal ends 15 a and 15 b , such that the spinal fixation rod 12 is convex with respect to the spinal column 3 . Referring to FIG. 3 , the surgical assembly 41 can further include an implant manipulation instrument 20 configured to apply a compressive force against a pair of implanted spinal fixation devices 11 , and subsequently lock the spinal fixation rod 12 in the spinal fixation devices 11 . In accordance with the illustrated embodiment, the implant manipulation instrument 20 includes a torque assembly 21 and an actuator 22 connected such that the torque assembly 21 and the actuator 22 can move with respect to each other in multiple degrees of freedom. As illustrated, the torque assembly 21 and the actuator 22 can rotate, pivot and translate relative to each other while remaining operably connected. The torque assembly 21 is configured as a driver 23 that includes a driver shaft 24 that extends along a central longitudinal axis L between a distal shaft portion 25 , an opposed proximal shaft portion 26 , and an intermediate shaft portion 27 that extends between the distal shaft portion 25 and the proximal shaft portion 26 along the longitudinal axis L. Thus, the distal shaft portion 25 and the proximal shaft portion 26 are spaced along the longitudinal axis L. The driver 23 also includes a handle 28 connected to the proximal shaft portion 26 of the driver shaft 24 , the handle 28 being configured to receive a torque and transfer the received torque to the driver shaft 24 . The actuator 22 includes a body 29 having a distal body portion 30 , a proximal body portion 31 and an intermediate body portion 32 extending between the distal body portion 30 and the proximal body portion 31 . Referring to FIG. 4 , the driver shaft 24 of the driver 23 extends along the longitudinal axis L, and defines an outer cross-sectional dimension D 1 , such as a diameter. In this regard, it should be appreciated that the driver shaft 24 can be substantially cylindrical or alternatively shaped as desired. The outer cross-sectional dimension D 1 of the driver shaft 24 can vary at different locations along the driver shaft 24 from the proximal shaft portion 26 to the distal shaft portion 25 . The implant manipulation instrument 20 includes a sleeve 33 . The sleeve 33 is a tubular shape that is sized such that the outer cross-sectional dimension D 1 of the driver shaft 24 fits within the sleeve 33 . When the driver shaft 24 is positioned within the sleeve 33 , the sleeve 33 can be coupled to the driver shaft 24 such that the sleeve 33 is able to rotate with respect to the driver shaft 24 about the longitudinal axis L. The implant manipulation instrument 20 can further include a connector 140 that couples the sleeve 33 to the driver shaft 24 as described above. The connector 140 prevents the sleeve 33 from falling off of the driver shaft 24 , such as by translating along the longitudinal axis L, while allowing the driver shaft 24 to rotate with respect to the sleeve 33 about the longitudinal axis L. As illustrated, the connector 140 is a spring clip but it should be appreciated that other connectors or couplings could be used to operably couple the sleeve 33 and drive shaft 24 as described above. Referring to FIGS. 2 and 4 , the driver shaft 24 defines a distally directed tip 34 that defines a terminal end of the distal shaft portion 25 . The tip 34 is configured to mate with the locking cap 19 in the recess 36 , and can be tapered inwardly as it extends distally so as to facilitate insertion into the recess 36 . The exact shape of the tip 34 and the recess 36 can be any of a number of shapes including but not limited to a flat head, a Phillips or crosshair end, a hex, or any other shape in which the tip 34 and recess 36 have some corresponding features that allow the tip 34 to enter the recess 36 and impart a torque on the locking cap 19 to rotate the locking cap 19 from the unlocked configuration to the locked configuration and vice versa. The handle 28 can extend proximally from the driver shaft 24 , and can be integral with the driver shaft 24 or can alternatively be discreetly attached to the driver shaft 24 via coupling 37 . The coupling 37 is configured to rotationally lock the handle 28 with respect to the driver shaft 24 , such that a torsional force or torque applied to the handle 28 is transferred to through the coupling 37 to the driver shaft 24 . Thus, the coupling 37 can include corresponding engagement members, such as an internal hex and an external hex that mate, on the driver shaft 24 and handle 28 that rotatably couple the handle 28 to the driver shaft 24 . One example of corresponding engagement drives would be an internal hex and an external hex. Handle 28 may also include a built in torque limiter 38 that prevents over tightening of the locking cap 19 when being fixed to the anchor seat 17 . Accordingly, the handle 28 is rotatably coupled to the proximal shaft portion 25 , such that a rotational biasing force applied to the handle 28 is transferred to the distal shaft portion 25 and the tip 34 . The handle 28 can be configured as desired, and includes a substantially T-shaped grip 39 presenting an engagement surface 40 . The grip 39 can be sized to allow a surgeon's hand to grab and apply a torque to the handle 28 . It should be appreciated that the grip 39 can be any structure or handle suitable for a surgeon to grab and apply a torque to such as but not limited to a knob, crank, protrusion, and the like. The driver 23 is configured to receive a torque, and selectively transfer the torque to the locking caps 19 , so as to move the locking caps to the locked configuration. Referring now to FIGS. 5A and 5B , the actuator 22 includes an actuator body 29 that has a proximal body portion 31 , an opposed distal body portion 30 , and an intermediate body portion 32 that extends between the proximal body portion 31 and the distal body portion 30 . The body 29 is defined by a top surface 42 , a bottom surface 43 , and opposing side surfaces 44 . Alternatively, the body 29 can have a circular cross-section or can define any suitable alternative shape as desired. The proximal body portion 31 includes a substantially flat panel 45 that is configured to receive a force F and impart that received force F to the distal body portion 30 . The top surface 42 and the bottom surface 43 can be wider at the panel 45 than at the intermediate body portion 32 , such that the actuator body 29 necks down from the panel 45 to the intermediate body portion 32 . The broader top surface 42 and broader bottom surface 43 allow for easier input of a force to the actuator 22 than at the intermediate body portion 32 . The intermediate body portion 32 defines a recess 46 that extends from the top surface 42 through the bottom surface 43 . The recess 46 has a length L 1 defined by a top inner wall 47 and a bottom inner wall 48 and a width W defined by opposing side walls 49 . The width is substantially equal to or slightly greater than the outer cross-sectional dimension D 2 of the driver shaft 24 such that the driver shaft is configured to extend through the recess 46 between the side walls 49 . The distal body portion 30 includes a body tip 50 and a neck 53 that connects the body tip 50 to the intermediate body portion 32 . The neck 53 can extend obliquely with respect to the intermediate body portion 32 , such that the body tip 50 is offset from the rest of the intermediate body portion 32 . The body tip 50 includes a distal end 51 that is configured to slidably and releasably contact the spinal fixation rod 12 (shown in FIG. 2 ). The distal end 51 can define a curved surface 52 having a curvature that matches the radius of the spinal fixation rod 12 (see FIG. 2 ). During operation, with further reference to FIG. 6 , a first spinal fixation device 11 is attached to a first vertebra 2 and a second spinal fixation device 11 ′ is attached to a second vertebra 2 ′ in the manner described above. In particular, each of the bone anchors 13 and 13 ′ of the spinal fixation devices 11 and 11 ′ are received by the anchor seats 17 and 17 ′, respectively. Furthermore, the bone anchors 13 and 13 ′ are attached to the vertebrae 2 and 2 ′ respectively, for instance, by screwing the bone anchors 13 and 13 ′ into the pedicles of the vertebrae 2 and 2 ′. The spinal fixation rod 12 is inserted through each of the anchor seats 17 and 17 ′ and placed in a desired position with respect to at least the second spinal fixation device 11 ′. The locking cap 19 ′ of the second spinal fixation device 11 ′ is moved into the locked configuration such that spinal fixation rod 12 and the second spinal fixation device 11 ′ cannot move with respect to each other. For instance, the tip 34 of the driver 23 is inserted into the recess 36 of the locking cap 19 ′ (see FIG. 2 ), and the driver 23 is rotated so as to tighten the locking cap 19 ′ against the spinal fixation rod 12 . The locking cap 19 of the first spinal fixation member 11 remains in the unlocked configuration such that the spinal fixation rod 12 and the first spinal fixation member 11 can move with respect to each other. The implant manipulation instrument 20 can further secure the spinal fixation assembly 10 . For instance, the driver 23 is positioned such that the intermediate shaft portion 27 is disposed within the recess 46 of the body 29 of the actuator 22 . Thus, the driver 23 and the actuator 22 intersect. The outer cross-sectional dimension D 1 of the intermediate shaft portion 27 and the width W of the recess 46 are sized such that the driver 23 and the actuator 22 can freely translate longitudinally with respect to each other, rotate about their respective central longitudinal axes with respect to each other, and pivot with respect to each other about respective axes angularly offset, e.g., perpendicular, with respect to their central longitudinal axes. The tip 34 of the driver 23 is moved into the recess 36 of the locking cap 19 . The body tip 50 of the distal body portion 30 is moved into contact with the spinal fixation rod 12 and the second spinal fixation device 11 ′. Specifically, the curved surface 52 of the distal end 51 is manipulated into slidable and releasable contact with the spinal fixation rod 12 and the bottom surface 43 at the body tip 50 of the actuator 22 is manipulated into releasable contact with the anchor seat 17 ′. Once both the tip 34 of the driver 23 and the body tip 50 of the actuator 22 are in contact with the spinal fixation assembly 10 as described above, a force F is applied to the bottom surface 43 ′ of the panel 45 and to the sleeve 33 . The force F biases the proximal body portion 31 toward the driver 23 , thereby causing the actuator 22 to pivot with respect to the driver 23 about a location where the top inner wall 47 contacts the intermediate shaft portion 27 . As the proximal body portion 31 pivots toward the proximal shaft portion 26 the distal body portion 30 pivots toward the distal shaft portion 25 . As a result the second spinal fixation device 11 ′ moves closer to the first spinal fixation device 11 , thereby compressing the vertebrae 2 and 2 ′. Once the desired level of compression is achieved, a torque is applied to the grip 39 , and thus the handle 28 . The applied torque is transferred to the tip 34 that imparts the torque to the locking cap 19 , thereby rotating the locking cap 19 from the unlocked configuration to the locked configuration. The torque can be continuously applied until a specified torque is achieved placing the locking cap 19 in the locked configuration. Because the driver shaft 24 is able to rotate with respect to the sleeve 33 as described above in reference to FIG. 4 , force F can be applied continuously to the actuator 22 and the sleeve 33 while the locking cap 19 is rotated to the locked configuration. For instance, a single surgeon can apply force F to the actuator 22 and the sleeve 33 with one hand while applying the torque to the grip 39 with the other hand. The rotational coupling of the sleeve 33 and the driver shaft 24 allows the surgeon's hand to remain in place on the sleeve 33 applying the force F while the driver shaft 24 rotates within the sleeve 33 transferring the torque from the grip 39 to the tip 34 . It should be appreciated that the steps described above for fixing the spinal fixation assembly 10 as described above may be rearranged as desired. Referring to FIGS. 7A and 8 , the surgical assembly 41 can further include an anchor delivery instrument 300 that is configured to guide a bone anchor to a target location, such as an underlying vertebra, in a desired position and orientation. In accordance with the illustrated embodiment, the anchor delivery instrument 300 includes a handle 301 and a guide 302 connected to the handle 301 . The handle 301 includes a body 303 that is elongate along a central longitudinal axis 306 , and defines a proximal end 304 and a distal end 305 that is spaced from the proximal end 304 along the longitudinal axis 306 . The guide 302 is elongate along a central axis 310 that can be angularly offset with respect to the longitudinal axis 306 , and includes a cannulated body 307 having a first portion 308 that can define a head 318 , and a second portion 309 spaced from the first portion 308 along the central axis 310 . The second portion 309 can define a shaft 320 that extends distally from the head 318 . The handle 301 includes a grip 315 , such that the body 303 supports the grip 315 and connects the grip to the guide 302 . The body 303 includes a first or proximal arm 322 that extends distally from the grip 315 inline with the longitudinal axis 306 , and a second or distal arm 324 that extends distally from the first or proximal arm 322 , and defines the distal end 305 of the handle 301 . The body 303 further includes a transition arm 314 connected between the first or proximal arm 322 and the second or distal arm 324 . The transition arm 314 can extend along a direction that is angularly offset with respect to the longitudinal axis 306 , such that the second or distal arm 324 is offset with respect to the first or proximal arm 322 along a direction angularly offset with respect to the longitudinal axis 306 . For instance, the second or distal arm 324 can be spaced closer to the distal end # of the guide 302 . The distal arm 324 can be attached to the head 318 of the cannulated body 307 as illustrated, or can be connected to the guide 302 at any alternative location along the cannulated body 307 , such as the shaft 320 . The guide 302 , including the cannulated body 307 , can be made from a radiolucent material, meaning that it can be seen through in an x-ray, unless otherwise indicated. The cannulated body 307 defines a first or proximal end 308 and a second or distal end 309 that is spaced from the first or proximal end 308 along the central axis 310 . In accordance with the illustrated embodiment, the handle 301 is attached to the cannulated body 307 at the proximal end 308 , though it should be appreciated that the handle 301 can be attached to the guide 302 at any alternatively location as desired. The head 318 of the cannulated body 307 can define a cross-sectional dimension greater than that of the shaft 320 , though it should be appreciated that the head 318 can define a cross-sectional dimension less than that of the shaft 320 , or substantially equal to that of the shaft 320 . It should be appreciated that the cannulated body 307 can be devoid of the head 318 , such that the shaft 320 of the cannulated body 307 extends from the proximal end 308 of the cannulated body 307 to the distal end 309 . The guide 302 defines a cannulation 311 that extends along the central axis 310 through the cannulated body 307 , and can extend through both the first and second ends 308 and 309 . The second end 309 includes a tip 312 that defines at least one tooth such as a plurality of teeth 317 . The tip 312 can be round or substantially circular, or can define any suitable alternative shape as desired. In accordance with the illustrated embodiment, the tip 312 defines a tapered profile along the circumferential direction, so as to define a distal point 331 . The tip 312 can be made from a radio-opaque material, which is more radio-opaque than the radiolucent material. The teeth 317 are configured to be driven into an underlying bone, such as a vertebra so as to secure the anchor delivery instrument 300 to the underlying bone. Thus, during a surgical delivery of a spinal fixation device 11 , a surgical component can be guided through the cannulation 311 to the underlying bone. The surgical component can be, for instance, a bone anchor 13 that is subsequently implanted in the underlying bone, a drill bit that is configured to produce a recess in the underlying bone, such that the recess is configured to receive the bone anchor 13 , a guide wire or Kirschner wire that facilitates implantation of the bone anchor 13 in the underlying bone, a fiduciary marker 7 (see FIGS. 10-11J ), or any other surgical component as desired. Thus, the cannulation 311 can define a cross-sectional dimension sized substantially equal to or slightly greater than the surgical component that is guided through the cannulation 311 . With continuing reference to FIGS. 7A and 8 , the guide 302 can include a first set 326 of at least one first radio-opaque marker 313 , such as a plurality of first radio-opaque markers 313 a - 313 d , and a second set 328 of at least one second radio-opaque marker 330 such as a plurality of second radio-opaque markers 330 . For instance, as descried above, the tip 312 can be radio-opaque so as to define the second radio-opaque marker 330 . The first set 326 of radio-opaque markers 313 can be carried by the guide 302 at any location spaced from the second radio-opaque marker 330 as desired. For instance, the first set 326 of radio-opaque markers 313 can be at least partially embedded in the cannulated body 307 . In accordance with the illustrated embodiment, the head 318 includes a radially outer portion 332 and an inner portion 334 that is distally recessed with respect to the outer portion 332 , such that the outer portion 332 defines a radially inner surface 336 that defines a radially outer perimeter of a void 338 that is disposed proximal of the proximally outer surface of the inner portion 334 . The cannulation 311 extends through the inner portion 334 in accordance with the illustrated embodiment. The first plurality of radio-opaque markers 313 a - d can be driven at least partially into the radially inner surface 336 , and thus at least partially embedded in the head 318 . In accordance with the illustrated embodiment, the first plurality of radio-opaque markers 313 are partially embedded in the head 318 , though it should be appreciated that the first plurality of radio-opaque markers 313 can alternatively be fully embedded in the head 318 . Alternatively still, the first plurality of radio-opaque markers 313 can be carried by the guide at any location proximal of the second radio-opaque marker 330 as desired. For instance, the first plurality of radio-opaque markers 313 can be at least partially embedded in or otherwise carried by the cannulated body 307 at any location proximal of the tip 312 . In accordance with the illustrated embodiment, the first set 326 of at least one radio-opaque markers 313 includes a plurality of radio-opaque markers 313 that are substantially equidistantly spaced circumferentially with respect to each other. While four radio-opaque markers 313 a - d are illustrated as spaced substantially 90° with respect to each other, the first set 326 of markers 313 can include any number of radio opaque markers 313 greater than or equal to one. It should be further appreciated that the plurality of radio-opaque markers 313 can alternatively be variably spaced from each other as desired. Furthermore, in accordance with the illustrated embodiment, the radio-opaque markers 313 define a first opposed pair 313 a and 313 c , and a second opposed pair 313 b and 313 d . The first set 326 of markers 313 further defines a first axis 340 that extends centrally through the first opposed pair 313 a and 313 c of radio-opaque markers, and a second axis 342 that extends centrally through the second opposed pair 313 b and 313 d of radio-opaque markers. In accordance with the illustrated embodiment, the axes 340 and 342 define an intersection 344 . Referring also to FIGS. 9A-B , the radio-opaque markers 313 and the circular tip 312 are shown in solid lines to represent their visibility in a radio image while the remainder of the guide 302 is shown in dotted lines to identify radiolucent material in the radio image. In accordance with the illustrated embodiment, the first and second sets 326 and 328 of at least one radio-opaque marker can be spatially positioned as desired to indicate that the guide 302 , and in particular the cannulated body 307 , is in a desired orientation with respect to a target location of an underlying bone. For instance, when distal point 331 of the tip 312 is driven into the underlying bone, such as a pedicle or a vertebra, and the cannulated body 307 is oriented as desired, the surgical component, such as the bone anchor 13 can be driven into the pedicle so as to remain contained in the pedicle as it is driven into the vertebra. It is appreciated that an improperly oriented bone anchor 13 or other surgical component can pierce the outer periphery of the pedicle or otherwise damage the pedicle or vertebra when driven into the vertebra. If the cannulated body 307 is found to be in an undesired orientation after the point 331 has been driven into the underlying target location, the orientation of the cannulated body 307 can be corrected to the desired orientation prior to driving the remainder of the tip 312 into the underlying bone and subsequently implanting the surgical component in the underlying bone. The actual orientation of the cannulated body 307 can be determined as desired or undesired based on a spatial relationship between the first and second sets 326 and 328 of radio-opaque markers. For instance, when the cannulated body 307 is oriented as desired, the radio image of the tip 312 is disposed at a desired location with respect to at least one of the first set 326 of radio-opaque markers 313 . When the cannulated body 307 is undesirably oriented, the radio image of the tip 312 is disposed at a location other than the desired location with respect to at least one of the first set 326 of radio-opaque markers 313 . For instance, in accordance with the illustrated embodiment, the desired location of the tip 312 relative to the at least one radio-opaque marker 313 of the first set 326 of radio-opaque markers 313 is substantially centered with respect to the radio-opaque markers 313 a - d . In accordance with the illustrated embodiment, the intersection 344 of the axes 340 and 342 of the radio-opaque markers 313 a - d is disposed substantially at the centroid 346 of the tip 312 , as illustrated in FIG. 9A . When the cannulated body 307 is undesirably oriented, the radio image of the tip 312 is positioned such that the centroid 346 of the tip 312 is offset with respect to intersection 344 of the axes 340 and 342 . It should be appreciated that the actual orientation of the cannulated body 307 can be compared to the desired orientation to determine if the actual orientation is in the desired orientation or an undesirable orientation from a view substantially inline with the central axis, or other known desired orientation, with respect to the underlying target location, which can be the pedicle of the underlying vertebra. Thus, the view can be an anterior-posterior view of a fluoroscopic image, or the view can be laterally oblique with respect to an anterior-posterior view. Referring now to FIG. 7B , the surgical assembly 41 can further include an anchor delivery assembly 131 that includes the anchor delivery instrument 300 and a trocar 348 that is configured to be inserted through the cannulation 311 of the guide 302 , and driven into the cortical wall of the underlying bone, e.g., pedicle, once the actual orientation of the cannulated body 307 has achieved the desired orientation. The trocar 348 can include a head 350 and a shaft 352 that extends distally from the head 350 , and a tip 354 that extends distally from the shaft 352 . The shaft 352 has a cross-sectional dimension substantially equal to or slightly less than that of the cannulation 311 , such that the cannulated body 307 can guide the shaft 352 distally as the shaft 352 translates in the cannulation 311 . The head 350 defines a cross sectional dimension greater than that of the shaft, such that the head 350 abuts the proximal end of the guide 302 when the trocar 348 has been fully translated distally within the cannulation 311 . Once the trocar 348 has been fully translated distally, the tip 354 protrudes distally beyond the point 331 of the tip 312 of the shaft 320 , such that the tip 354 of the trocar 348 can pierce the cortical wall of the underlying bone at an insertion point without causing the tip 312 of the cannulated body 307 to also pierce the cortical wall of the underlying bone. The tip 354 can be driven through the cortical wall and into the cancellous portion of the target bone. Accordingly, during operation, a radio image of the guide 302 and spinal region is examined to determine whether the guide 302 is in the desired orientation or an undesired orientation. If the guide 302 is in an undesired orientation, the cannulated body 307 can be pivoted until it is determined that the cannulated body 307 is in the desired orientation. Once the actual orientation of the cannulated body 307 is the same as the desired orientation, the trocar 348 can be tapped, for instance at the head 350 , using a mallet or any suitable alternative device so as to drive the trocar tip 354 through the cortical wall of the underlying target bone so as to create a pilot hole in the underlying bone. It should be further appreciated that the teeth 317 can be caused to grip the underlying bone before or while the guide 302 is oriented as desired. For instance, a mallet or any suitable alternative device can tap the proximal end 308 , or head 318 , of the cannulated body 307 so as to cause the teeth 314 to bite into the cortical wall of the underlying bone prior to driving the trocar through the cortical wall. Next, the trocar 348 can be translated proximally so as to remove the tip 354 from the underlying bone and further remove the trocar 348 from the cannulation 311 , and a surgical component can next be inserted into the cannulation 311 and driven distally into the pilot hole created by the trocar 348 . For instance, the bone anchor 13 , without the bone anchor seat 17 attached, can be inserted into the cannulation 311 , which can be sized substantially equal to or slightly greater than the head of the bone anchor 13 . The driver instrument of the bone anchor 13 can translate the bone anchor 13 distally through the cannulation 311 , and rotate the bone anchor 13 such that the tip of the threaded bone anchor shaft 60 is driven into the underlying bone through the pilot hole created by the trocar 348 . Once the bone anchor 13 has been driven into the underlying bone, the guide 302 can be removed from the bone anchor 13 by translating the cannulated body 307 proximally until the cannulation 311 has cleared the bone anchor head. Once the guide 302 has been removed, the bone anchor seat 17 can be popped downward onto the head of the bone anchor 13 as described above. As described above, the surgical component can define a fiduciary marker 7 , which can include the bone anchor 13 , or any alternative structure that can be implanted in the underlying bone (see FIGS. 10-11J ). Thus, the fiduciary marker 7 can be driven through the cannulation 311 and into the pilot hole created by the trocar 348 as described above with respect to the bone anchor 13 . Alternatively or additionally, once the trocar 348 has been driven through the cortical wall of the underlying bone and subsequently removed, a drill bit can be driven distally through the cannulation 311 and into the pilot hole created by the trocar 348 , and subsequently further into the underlying bone. The drill bit can subsequently be removed, and the bone anchor 13 or other fiduciary marker 7 can be subsequently inserted in the pilot hole created by the drill bit. Referring now to FIG. 10 , the fiduciary marker can be configured as the bone anchor 13 as described above, or any alternative radiographically visible pedicle reference implant. For instance, the fiducial marker 7 is inserted into a patient's vertebra 2 , such as the pedicle, and provides a distinct reference marker to aid the surgeon in fluoroscopically navigating the surgical workspace. The fiducial marker 7 provides a reference point from which the surgeon can generally identify several noteworthy areas of the spinal region 1 including the lamina 6 , disc space 4 , exiting nerve roots, and other anatomical structures of a vertebra 2 prior to, and during, decompressive surgical procedures. For instance, Zone 1 identifies the boney region immediately adjacent to the fiducial marker 7 . This area provides a desired navigational reference location, such as the pedicle. Zone 2 , as illustrated, can be bounded by the disc space 4 at the cranial aspect (typical surgical target) and the exiting nerve root in the lateral, caudal quadrant. Zone 3 , as illustrated, can extend to the cranial-most side of both the cranial disc space 4 adjacent to the boney region identified by Zone 1 and the caudal disc space 4 adjacent to the boney region identified by Zone 1 . By marking a known pedicle position, the surgeon can maintain a navigable reference even after the patient's anatomy has been significantly altered during the surgical procedure. Referring now to FIGS. 11A-11J , the fiducial markers 7 can provide non-ambiguous anchoring locations or mounting posts for attachment of various surgical instruments, such as access ports, retractor blades, suction tubes, targeting devices, drill guides or endoscopic instruments, that may be used when performing decompression, fusion, and fixation procedures of the spine. The various fiducial markers 7 can be constructed as desired, for instance as illustrated by the fiducial markers 7 a - 7 f illustrated in FIGS. 11A-11J , or alternatively as illustrated by the bone anchor 13 . Referring to FIG. 11A , the fiducial marker 7 a is illustrated as a spinal fixation device 11 , including the bone anchor 13 and the bone anchor seat 17 as described above. Referring to FIG. 11B , the fiducial marker 7 b is illustrated as the bone anchor 13 of FIG. 11A , including a shaft 8 presenting external threads 9 , and a head 137 having a substantially spherical outer surface 139 . As described above, the bone anchor seat 17 can be popped onto the outer surface 139 of the head 137 after the shaft 8 has been driven into the underlying bone. As illustrated in FIGS. 11C-G , the fiducial markers 7 c - 7 e can include a shaft 8 and a head 137 disposed at the proximal end of the shaft 8 . The heads 137 can be constructed in accordance with any embodiment as desired. Various heads are illustrated in FIGS. 11C-G . It should be appreciated, however, that the fiducial markers 7 can be provided without heads, and that the shafts 8 can be constructed in accordance with any embodiment as desired. For instance, as illustrated in FIG. 11I , the shaft 8 can be unthreaded. Each of the fiducial markers 7 a - 7 f can define a cannulation extending longitudinally through the shaft 8 that is configured, for instance, to receive a guide wire that extends into the underlying bone. The markers 7 a - 7 f may be further designed to accommodate any number of degrees of freedom of movement of the attached instrumentation. The mechanisms to orient and/or secure the instruments in the surgical site may be a function of the markers 7 a - 7 f , the surgical instrument, or both. The markers 7 a - 7 f can be removed prior to closing the surgical site or, alternately, the markers 7 a - 7 f can be retained as one of the elements of the fixation hardware to be used in the surgical procedure, such as the embodiment shown for marker 7 a , in which a spinal fixation device 11 , including a bone anchor 13 and an anchor seat 17 , is used as the marker device, or the embodiment shown for marker 7 b , in which a bone anchor 13 is used as the marker device and a bottom-loading or “pop-on” anchor seat 17 is coupled over the head 137 of the bone anchor 13 . Pedicle targeting aids, such as the anchor delivery instrument 300 described above can also be coupled to the various fiducial markers 7 a - 7 f . The void created in the underlying bone during insertion of the fiducial markers 7 a - 7 f may subsequently define a pilot hole for placing permanent hardware, such as spinal fixation devices 11 , after removal of the fiducial marker 7 . The markers 7 a - 7 f may be formed of radio-opaque material or include radio-opaque portions or elements for fluoroscopic visibility. In some embodiments, the fiducial markers 7 a - 7 f and/or other components of the related system can be disposable. Although the disclosure has been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. For instance, it should be appreciated that the cross-sectional dimensions described herein can define diameters, unless otherwise indicated. Moreover, the scope of the present disclosure is not intended to be limited to the particular embodiments described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure.

1a

This is a divisional application of U.S. Ser. No. 09/548,533, which was filed on Apr. 13, 2000 now U.S. Pat. No. 6,527,801. BACKGROUND OF THE INVENTION The present invention generally relates to expandable intraluminal vascular grafts, most often referred to as stents, and more particularly pertains to biodegradable stents which completely or partially degrade or are bioabsorbed over a period of time after deployment. Stents are used to maintain the patency of vessels in the body. They are typically advanced through the vasculature to the deployment site while in a contracted state where they are then expanded to engage the vessel walls and thereby establish a flowpath therethrough. A stent can be moved along a guide wire previously positioned in the vessel and then expanded by the inflation of a balloon about which such stent is disposed. Subsequent deflation of the balloon and removal of it along with the guidewire leaves the stent in place and locked in its expanded state. It has been found that the continued exposure of a stent to blood can lead to undesirable thrombus formation, and the presence of a stent in a blood vessel can over time cause the blood vessel wall to weaken, which creates the potential for an arterial rupture or the formation of aneurisms. A stent can also become so overgrown by tissue after its implantation that its usefulness may be substantially diminished while its continued presence may cause a variety of problems or complications. In certain situations it is therefore desirable for the stent to be biodegradable or bioabsorbable so as to curtail the adverse risks that would otherwise be associated with the stent's continued presence once its usefulness at the treatment site has ceased or has at least become substantially diminished. To such end, some stents have heretofore been wholly constructed of materials that are biodegradable or bioabsorbable. It is of course necessary to select a material that while biodegradable is nonetheless biocompatible and additionally, has the physical properties necessary to properly serve its function as a stent. Such physical properties include, among others, sufficient strength to support the loads a particular stent is to be subjected to in its function as a splint, the radial flexibility necessary for it to undergo expansion, longitudinal flexibility to allow it to be advanced through a contorted vasculature and conceivably to adapt to a non-linear deployment site. Such characteristics have heretofore been achieved with the use of certain polymer materials such as polylactic acid, polylactic acid-glycolic acid copolymer, and polycaprolactone. However, all such previously known biodegradable/bioabsorbable stents exhibit bulk erosion and are as a consequence prone to break up into large particles as the matrix breaks down. Additionally, such materials have also been used as stent coatings to gradually release pharmacological agents that are infused throughout the coating. However, the bulk erosion to which such materials are inherently prone to can cause the coating to flake off or otherwise become detached. Should such large particles actually become dislodged before becoming completely degraded, they could be washed downstream and cause emboli. A biodegradable stent is therefore needed that is initially capable of providing the necessary structural support to a body lumen and then gradually and completely degrades or is absorbed in a manner that precludes a break-up into large particles. Similarly, a biodegradable coating is needed that is not prone to flaking or breaking up into large particles. By preventing the break-up of the stent or of the stent coating into large particles that may subsequently be swept downstream, the potential for embolic complications is thereby avoided. SUMMARY OF THE INVENTION The present invention provides a stent or optionally, a stent coating which degrades in a very controlled and uniform manner so as to substantially preclude the possibility of sizeable particles becoming detached and possibly causing embolic problems downstream. This is achieved by employing a material in the construction of the entire stent or in the coating of the stent that erodes in a very controlled manner. Such material is selected for its strength characteristics as well as its tendency to erode from the surface inwardly rather than being subject to bulk erosion. By incorporating pharmacological agents within the material, the stent or stent coating not only eventually vanishes from within the body lumen in which it was implanted but additionally dispenses the incorporated drug in a gradual manner. Materials that exhibit the desired surface eroding characteristics without being subject to bulk erosion include polymers wherein the degradation rate of the matrix is faster than the rate of water penetration into the interior of the polymeric mass. Such polymers are hydrophobic but have water-labile linkages interconnecting the monomers. The hydrophobic property precludes water from penetrating into the interior of the polymer while water labile linkages nonetheless subject the surface to gradual erosion. As a result, the stent gradually degrades from the surface inwardly, substantially without the risk of large particles becoming dislodged. While hydrophobic polymers with water-labile linkages are known, their limited strength and processing capabilities have restricted their usage to passive devices that neither perform a structural function nor are subject to stress or distortion. Drugs infused throughout such material implanted in the body in the form of a tablet or other shape are gradually released as the polymer degrades. As such, these surface degrading polymers have functioned as an effective drug delivery vehicle. The use of such polymers in stent applications has however been precluded as they are unable to support a lumen wall or remain attached to a stent as it undergoes deformation during its expansion. The materials employed in either wholly forming a stent or in coating a stent in accordance with the present invention include hydrophobic polymers having water-liable linkages connecting the monomers that are fortified with the incorporation of ester or imide bonds. Examples of such polymers include polyanhydrides and polyorthoesters. Additionally, by employing such polymers in stent applications, a single device can be called upon to provide the necessary support to a body lumen and simultaneously dispense a pharmacological agent in a controlled manner. These and other features and advantages of the present invention will become apparent from the following detailed description of a preferred embodiments which illustrate by way of example the principles of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The stent of the present invention is employed to support or otherwise treat a targeted site within the vasculature. Such stent is introduced into the vasculature, advanced therethrough to the deployment site and expanded using conventional techniques and delivery systems. Once in position and subject to the continuous flow of blood therethrough, it gradually degrades, substantially without the risk inherent in previously known biodegradable stents or stents with biodegradable coatings of breaking up into or releasing sizeable particles that may be swept downstream and cause emboli. The material employed in the manufacture of the stent of the present invention is a polymer that is simultaneously hydrophobic and has water-labile linkages interconnecting its monomers that are further fortified by ester or imide bonds. The hydrophobic nature of the polymer precludes the incursion of water into its interior while the water-labile bonds that are exposed on its surface nonetheless cause the polymer to degrade. Degradation thereby exclusively progresses from the material's surface inwardly to yield a much more uniform degradation rate and to preclude bulk erosion. The incorporation of the imide or ester bonds serves to impart sufficient strength to the material to enable it to provide the support that is required of a stent. Alternatively, if the material is used as stent coating, the incorporation of the imide or ester bonds impart sufficient strength to the material to prevent it from flaking off or otherwise becoming detached as the underlying stent undergoes the distortion attendant its being expanded by for example the inflation of a balloon. Many of the stent's ultimate performance characteristics are controllable by the appropriate selection of the various dimensional parameters of the stent. Increasing the dimensions of various structural elements of the stent will generally serve to increase strength and decrease flexibility. Such effect would result from both an increase in the width or in the wall thickness of the stent's structural elements. The time period in which the stent would become totally degraded or absorbed is a function of the wall thickness of the various elements while the degradation rate is a function of the total area exposed to contact with the blood. By for example selecting a stent configuration which employs a large number of relatively narrow spine and strut elements to achieve a particular level of strength, the time in which the stent degrades when subjected to the blood flow can be substantially accelerated. Conversely, a stent configuration in which a relatively few, wide structural elements are employed causes the degradation rate to be somewhat retarded. The stent's ultimate performance characteristics are of course also controllable by the appropriate selection of chemical variables. For example, the number of imide or ester bonds that are incorporated in the polymer material not only affects the ultimate strength and flexibility characteristics of the stent, but also has an effect on the rate at which the material degrades when subjected to blood flow. An increased bond content enhances strength, decreases flexibility and increases degradation time. The specific requirements of a particular application will ultimately determine the optimal combination of the stent configuration, wall thickness and ester or imide bond content. Polymers that satisfy the above-described requirements include polyanhydrides and polyorthoesters. Representative examples of polyanhydride polymers suitable for use in the construction of a stent or formulation of a stent coating in accordance with the present invention include anhydride-co-imide ter polymers containing trimellitylimido-L-tyrosine, sebacic acid (SA) and 1,3 bis(carboxyphenoxy)propane. Other examples of suitable polyanhydrides include poly(fatty acid—sebacic acid) synthesized from erucic acid and sebacic anhydride p(EAD:SA) and poly(L-lactic acid-co-L-aspartic acid). Representative examples of polyorthoester polymers suitable for use in the construction of a stent or formulation of a stent coating in accordance with the present invention include poly(4-hydroxy-L-proline ester), poly(1, 10 decanediol-1, 10 decanediol dilactide) and poly(1, 2, 6 hexanetriol-trimethylorthoacetate). An ester or imide content of 20%-40% has been found to be effective to provide sufficient strength for a stent application. The process for forming a polymer stent is well known in the art. A stent of the present invention is formed by first causing the appropriate reagents to react to form the desired polyanhydride or polyorthoester composition. During copolymer synthesis, the imide content of such composition is increased by incorporating higher imide containing monomers like trimellitylimido-L-tyrosine. Increasing imide content results in higher strength material. Flexibility of polyanhydrides like p(EAD:SA) can be increased by increasing the percentage of erucic acid dimer (EAD) during polymer synthesis. The ester content of such composition is increased by incorporating higher ester containing monomers such as L-proline ester or trimethyl orthoacetate. Selected pharmacological agents can be added to the reagents so as to incorporate such materials throughout the polymer to thereby provide for the gradual dispensation of the drug over the service life of the stent. The blending may be accomplished either in solution or in a melt state. Drugs such as for example heparin or other proteins can readily be added to the reactants before or during the polymerization process. Alternatively, some drugs may be infused throughout the polymer after polymerization is completed. If desired, the drug may be applied to the surface of the cured polymer to cause the entire dosage to be released shortly after implantation. The stent may be formed by any of a number of well known methods including the extrusion of the polymer into the shape of a tube. Preselected patterns of voids are then formed into the tube in order to define a plurality of spines and struts that impart a degree of flexibility and expandability to the tube. Alternatively, the drug loaded polymer may be applied to the selected surfaces of a stent formed of, for example, stainless steel or Nitinol. In order to coat all of the surfaces of the stent, the stent is immersed in the molten polymer. Alternatively, the polymer may be extruded in the form of a tube which is then co-drawn with a tube of stainless steel or Nitinol. By co-drawning two tubes of the polymer with a metal tube, one positioned about the exterior of the metal tube and another positioned within such metal tube, a tube having multi-layered walls is formed. Subsequent perforation of the tube walls to define a preselected pattern of spines and struts imparts the desired flexibility and expandability to the tube to create a stent. While a particular form of the invention has been illustrated and described, it will also be apparent to those skilled in the art that 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 by the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority from U.S. Provisional Patent Application Ser. No. 60/472,112, filed May 21, 2003, and entitled “Exercise Machine”. The disclosure of that patent application is incorporated herein by reference in its entirety. In addition, the present invention is an improvement over the “Therapeutic Treatment Machine” disclosed in my prior U.S. Pat. No. 5,505,691, issued Apr. 9, 1996 (referred to herein as the '691 patent”), the entire disclosure from which is incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Technical Field The present invention relates to methods and apparatus for therapeutically treating the human body and, more particularly, to a method and apparatus for relieving discomfort and pain in the back, spine and neck of a human patient. 2. Discussion of Related Art The essence of the invention disclosed in my prior in my prior U.S. Pat. No. 5,505,691 (referred to herein as the '691 patent”) is the alternating application of compression and traction forces to the body of a patient to therapeutically treat the patient's back. A treatment table has a longitudinally slidable upper body pad for supporting the upper back, shoulders and head of a supine patient, and freely rotatable transversely extending rollers for supporting the lower back, buttocks and thighs of the patient. A selectively controlled, motor driven, movable platform is adapted to engage the feet of the patient. A reversible electric motor longitudinally reciprocates the movable foot platform a pre-selected distance, adjustable by the patient, to sequentially and repetitively place the patient in tension and compression. The spacing between the upper body support pad and the motor-driven foot support platform is adjustable to accommodate differences in patient torso lengths. The magnitude of the compression and traction forces can be selectively controlled by the patient. The table is easily deployed for use and is optimally collapsible into a unit that is easily hand-carried by a patient while traveling. A commercial embodiment of the invention described my prior patent (the BackPro CPM Motorized Table) was constructed of 1″×2″ aluminum tubing, and by welding the table corners. This necessitated Heliarc welding, an expensive, time-consuming process that took over two hours per machine because of the sixty-four locations to be welded. Heliarc welding typically costs in excess of $65.00 per hour. In addition, the BackPro CPM Motorized Table used a complex operating system consisting of a cable drive activated by a reversing motor controlled by micro-switches and relays. It is desirable, both from a reliability perspective and for user-friendly considerations to simplify this function. The method used in the BackPro CPM Motorized Table to hold the patient's feet in the molded box involved a t-bar hinged at the bottom and maintained against the foot with force applied against the t-bar by a threaded handle. This proved to be not very effective and was, in fact, ultimately replaced with two straps that went over the feet and around posts attached to the motor box. That strapping method, while holding the feet in place, also meant that the patient, who likely had a sore back to begin with, had to bend forward and stretch to strap his/her feet in place. OBJECTS AND SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a back exercise table of the type disclosed in the '691 patent wherein all of the advantages of the table are maintained but the disadvantages described above are eliminated. It is a more specific object of the present invention to provide an improved structure of the back exercise table disclosed in the '691 patent which eliminates the need for Heliarc welding. It is another object of the present invention to provide an improvement over the back exercise table disclosed in the '691 patent in the form of a simpler method and apparatus for the effecting reciprocating motion that produces the alternating compression and traction forces. It is still another object of the present invention to provide an improvement over the back exercise table disclosed in the '691 patent in the form of a simpler method and apparatus for engaging the feet of the patient using the table. The aforesaid objects are achieved individually and in combination, and it is not intended that the present invention be construed as requiring two or more of the objects to be combined unless expressly required by the claims attached hereto. In accordance with one aspect of the present invention, cast aluminum corner members are provided with open U-shaped connector members extending therefrom, each connector member having a pair of parallel spaced arms adapted to be slidably inserted into an elongated tubular frame component of the table. The orthogonally related arms of the U-shaped connectors are secured in the aluminum tubular frame members by means of an adhesive, typically a two-component acrylic glue. Each corner member additionally includes a leg engagement member, orthogonally related to the arms and adapted to be removably received in a tubular table leg and held in place by means of a V-shaped plastic spring, or the like. The entire corner member, including the frame engaging arm and the leg engagement member, is preferably made from a single piece of cast metal, preferably aluminum. With this construction and the elimination of the welding steps, a table can be manufactured every fifteen minutes or less. In accordance with another aspect of the invention, the cable drive arrangement of my prior patented system is replaced by a simple rotating drive arm or plate driven by a gear motor to reciprocate the foot platform. The drive arm drives a linkage arm which reciprocates longitudinally. When the power switch is actuated 12VDC is fed to a timer that is manually adjusted by the patient to set the duration of a treatment. The timer passes current to the gear motor causing the motor drive arm to be rotated and the foot platform to be reciprocated by the linkage arm. A microswitch is normally closed and connected in parallel with the timer to permit activation of the gear motor until the arm of the microswitch is depressed. Therefore, when the timer, which is adjusted by the patient to set the duration of the treatment, completes its cycle, current is still fed to the gear motor until the motor drive arm actuates the microswitch at the end of a foot platform reciprocation cycle. This opens the circuit and stops the gear motor in the correct position. This arrangement effects the necessary reciprocating motion with a much simpler mechanism than described in my prior patent, thus saving a considerable amount of time and money, while accomplishing the same goal. The approach in the present invention to holding the patient's feet in place utilizes a T-bar having an adjustment slot and held in place on the motor box with a threaded handle. This system allows the user to set T-bar one time while seated or standing, and then to slide his/her feet into position from the sides while in a supine position on the machine, thereby locking the feet in place on the foot platform when the machine is to be used. A second advantage of this arrangement is that the force applied to the T-bar presses the T-bar against the motor box, thereby stabilizing the T-bar rather than applying forces tending to tear the T-Bar from the motor box. The above and still further objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments thereof, particularly when taken in conjunction with the accompanying drawings wherein like reference numerals in the various figures are utilized to designate like components. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view from below of a corner member utilized in the frame of the therapeutic back exerciser according to the present invention. FIG. 2 is a perspective view from above of the corner member of FIG. 1 . FIG. 3 is a perspective view from below of another embodiment of the corner member utilized in the frame of the therapeutic back exerciser according to the present invention. FIG. 4 is a schematic diagram of the electrical circuit used to control operation of the back exerciser according to the present invention. FIG. 5 is a bottom view in plan of the therapeutic back exerciser according to the present invention. FIG. 6 is a detailed bottom view in plan of the foot platform portion of the therapeutic back exerciser of FIG. 5 . FIG. 7 is a detailed bottom vies in plan of the motor and motor drive bar portion of the therapeutic back exerciser of FIG. 6 . FIG. 8 is a perspective view from above of the foot platform end portion of the therapeutic back exerciser of FIG. 4 . FIG. 9 is an exploded view in partial perspective of the T-Bar and adjustment screw utilized in FIG. 8 . FIG. 10 is a view of the patient height adjustment of the cartridge embodiment in FIG. 4 . FIG. 11 is a view in perspective of the therapeutic back exerciser according to the present invention. FIG. 12 is a perspective view of a corner member of FIG. 1 showing the method of connecting the corner member to a frame member and a leg of the machine of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the accompanying drawings in greater detail, a therapeutic treatment machine 10 according to the present invention includes a rectangular table frame 12 supporting an upper body pad 14 located toward the head end of the table, a series of six freely rotatable massage rollers 16 located toward the middle of the table and a motor driven, longitudinally and selectively reciprocable foot support platform 20 located toward the foot end of the table. Rectangular frame 12 is made of, for instance, aluminum angle or tube, and has a forward or torso-supporting frame section 26 housing the upper body pad 14 and rollers 16 , and a rearward or foot-supporting frame section 28 housing the foot support platform 20 . Frame sections 26 and 28 are rectangular and of similar size and shape. Forward section 26 has a forward or head end member 30 and a rearward end 34 extending transversely between opposite longitudinally extending side members. Table legs 40 support the machine at a convenient height for ease of use (e.g. twenty to twenty-four inches) and extend downward from the four corners of forward frame section 26 . Rearward frame section 28 has transversely extending forward end 42 and rearward end 46 , and opposite sides 48 and 50 . Table legs 40 extend downward from the back corners at rearward frame section 28 . Table legs 40 are removably attached to frame 12 for ease and compactness of storage and may be conveniently but removably locked into frame 12 with spring-loaded detents of conventional design. Forward frame section rearward end 34 may be connected along the lower surface to the lower surface of rearward frame section forward end 42 by a hinge to allow the two sections to be folded together for portability and storage compactness. As best illustrated in FIGS. 1 , 2 , 3 and 12 of the accompanying drawings, the corner joints of the table frame have a unique and simple construction that permits relatively rapid assembly of the table during manufacture. Cast aluminum corner members 301 are provided with open U-shaped connector members extending therefrom in orthogonal relation, each connector member having a pair of parallel spaced arms 302 adapted to be slidably inserted into an elongated tubular frame component, for example frame side 36 , of the table. The arms 302 of the U-shaped connectors are secured in the aluminum tubular frame members by means of an adhesive, typically a two-component acrylic glue. Each corner member 301 additionally includes a leg engagement member 303 adapted to be removably and telescopically received in a tubular table leg 40 and held in place by means of a V-shaped plastic spring, or other conventional detent mechanism for telescoping members. With this construction and the elimination of the welding steps, a table can be manufactured every fifteen minutes or less. The connector arms 302 are sized and spaced to provide a slidable fit into the frame members 36 , et al, which are typically one inch by two inch cross-section aluminum tubes. The leg engagement member 303 is sized to slidably fit into a leg 40 which is typically a one inch square cross-section aluminum tube. The cast one-piece corner members are very inexpensive, and the adhesive attachment technique is much faster and less expensive than Heliarc welding. Two or multi-component adhesive or sealant systems consist of two or more resins or a resin and a hardener, crosslinker, activator or catalyst that when combined react and cure into a polymerized compound or bond. The component systems are typically mixed immediately before assembly and then applied. The process for constructing the frame at each corner is as follows. A. The two-part acrylic glue is in a two-part tube that has a mixing nozzle on the end and is dispensed with a gun onto a Teflon sheet. B. The glue is inserted into the end of a frame member (e.g., member 36 ) along the end portions of the two shorter (e.g., one-inch) sides of the aluminum tube with a plastic applicator. C. The glue is applied to the arms 302 which are then slid into the tubular frame member 36 . D. After all the corners are assembled the frame is put into a jig and allowed to cure for seven to eight minutes, after which the frame is removed and the next frame that was being assembled during the cure time is ready to be put in the jig. As best illustrated and described in the '691 patent, friction bearings of, for instance, Teflon, mounted on sections of aluminum channel, are attached to the underside of the upper body pad 14 and are slidably mounted in angle stock attached along the inner surfaces of the forward frame section sides. Resistance to movement of upper body pad 14 along angle stock is proportional to the weight exerted on the pad and is equal in the forward and rearward direction. The forward and rearward displacement or stroke of the upper body pad along angle stock is limited by the forward end 30 of the forward frame section 26 and the mounting arrangement for rollers 16 . The upper body pad may comprise a plywood deck with foam rubber or other resilient padding material affixed to the upper surface and covered with a durable material offering frictional resistance to the head, shoulders and upper back of the patient. Rollers 16 of conventional design are mounted in the forward frame section 26 and extend transversely of the frame with their axes parallel to one another at a location between end 34 and the upper body pad 14 . The rollers are partially exposed above the forward frame section 26 to contact the patient's lower back or buttocks. The rollers are rotatably mounted to opposite sides of the frame by bronze pins extending from the axles of the rollers, through washers and holes drilled in the inner surfaces of aluminum channel 74 attached to the inner surfaces of the frame sides and into bearings that are press-fit into the channels. Foot support platform 20 has a generally rectangular base 78 sized to fit horizontally between rearward frame section sides 48 and 50 . A molded foot rest assembly 80 is attached to the upper surface of base 78 . as described in my '691 patent, bearing blocks of, for instance, Teflon, are held against the lower surface of each corner of base 78 by bolts passing through holes in foot rest assembly 80 , holes in base 78 , holes in the bearing blocks and holes in sections of aluminum angle and threadedly received by nuts. Slots 100 formed in the outer surfaces of the bearing blocks receive the horizontal leg of the angle stock rigidly attached to the inner surfaces of frame sides 48 and 50 to slidingly support foot support platform 20 in the table frame 12 . The molded foot rest assembly 80 is attached to the top of base 78 and has a central console box 104 extending along its central front portion. Padded heel rests 110 are disposed on either side of console box 104 , and footplate support brackets 112 are transversely spaced from one another at respective locations behind console box 104 . Support brackets slidably and removably receive rectangular foot support plates 126 in a position wherein plates 126 extend upwardly and rearward from platform 20 in transversely spaced relation. A T-bar 106 has a stem portion 107 with a lower end extending toward base 78 through the space between brackets 112 to a location rearward of brackets 112 . The width of the T-bar stem 107 permits it to fit between brackets 112 , thereby permitting the stem to extend upwardly and forwardly between the brackets 112 and the foot support plates 126 . Cross member 109 of T-bar 106 extends transversely in both directions from the top of stem 107 and has padded foot clamps 118 secured at each end thereof. Foot clamps 118 are hollow cylindrical padded members configured to slide onto respective ends of cross member 107 in positions forwardly of and in longitudinal alignment with respective foot plates 126 . T-bar stem 107 has a slot 111 defined therethrough and extending longitudinally along a portion of the stem. A threaded bolt 122 extends through slot 111 and is retained in threaded engagement with a threaded hole in console box 104 . When the bolt is tightened in place by rotation of is actuator knob 124 , the otherwise unsecured T-bar stem 107 is secured to the machine. The degree of insertion of bolt 122 into the hole in the console determines the slack space between foot clamps 118 and foot plates 126 , thereby providing adjustability of that spacing for different patents. Importantly, once the spacing is set for a particular patient, it does not have to be re-adjusted for that patent. The footplate support brackets 112 define respective slots on opposite sides of console box 104 and are sized to removably receive and support flat foot plates 126 in a generally upright position braced by support box 112 . Foot plates 126 are removable for compact storage and portability. As noted previously above, the method used in my prior machine to hold the patient's feet in the molded box involved a t-bar hinged at the bottom and held against the foot with pressure applied against the t-bar by a threaded handle. The aforementioned method of holding the feet in place was not very effective and was, in fact, ultimately replaced with two straps that went over the feet and around posts attached to the motor box. That strapping method, while holding the feet in place, also meant that a person with a bad back had to bend over to strap his/her feet in place. The approach to holding the feet in place with the present invention uses T-bar 106 with a four inch adjustment slot 111 held in place on the molded box with a threaded handle 124 . This system allows the user to set the T-bar one time and then to slide his/her feet into position from the sides, locking them in place while in a supine position when the machine is to be used. A second advantage to this approach is that the force applied to the T-bar presses the T-bar against the motor box, thereby stabilizing the T-bar instead of tending to tear it from the motor box. Positioning arrows may be inscribed on the upper sides of the molded foot rest assembly to align with a series of marks inscribed along frame sides to indicate various separation distances between the upper body pad 14 and foot support platform 20 corresponding to various patient torso lengths. As described in the '691 patent, transverse hinges may be mounted on the front and rear edges, respectively, of foot support platform 20 and are spring biased in a partially open position. Safety stop microswitches may be mounted on the front and rear edges, respectively, of foot support platform 20 and activated by the rotational closing of the hinges in response to a body part or other obstruction closing the hinge by blocking the unimpeded forward or backward movement of the foot support platform within frame 12 . Activation of either microswitch causes the platform reciprocation to immediately stop, as is described more fully below, to prevent accidental injuries. The drive system of the present invention uses a simple rotating arm driven by a gear motor. Specifically, 12VDC is fed from a wall adapter to a female plug 201 and is then routed for safety through a circuit breaker 202 and then to a four-position connector/junction box 204 . From the connector the red wire in conductor cord 206 is fed to an on/off switch 207 in a control box 208 . The green wire is energized when the switch 207 is turned on, and feeds 12VDC to the gear motor 205 through the red motor wire at the connector 204 . The yellow wire from the switch 207 joins the brown wire at the connector 204 and then feeds current to timer 209 . The black wire from the timer joins the black wire from the gear motor 205 at the connector. When the switch 207 is turned on, 12VDC is fed to the timer 209 . When the timer is activated current is fed to the gear motor 205 . The gear motor rotates a drive arm 210 and the machine is activated. The microswitch 203 activates the gear motor 205 until its actuator arm is depressed. Therefore, when the timer 209 completes its cycle, current is still fed to the gear motor 205 until the drive arm 210 contacts the microswitch 203 with a rubber bumper located under the end of the drive arm 210 opposite the bearing assembly 213 . This opens the circuit and stops the gear motor in the correct position. The rotation of the drive arm 210 moves the motor box horizontally approximately seven inches in a reciprocating forward and rearward motion through a bearing assembly 212 and linkage arm 213 which is connected to the frame of the machine by a threaded retaining screw 214 . Specifically, the distal end of linkage arm 213 passes through a space defined by the bottom surface of frame member 42 and a U-shaped bracket having the ends of its legs secured to that surface near the longitudinal center of member 42 . Linkage arm 213 is provided with a series of longitudinally spaced apertures through which retaining screw can be selectively inserted to determine the effective length of arm 213 for operation with a patient of given torso and body length. The speed or pace of the reciprocating displacements is a function of the tube motor rotation speed. This system allows the necessary motion to take place with a much simpler mechanism, thus saving a considerable amount of time and money, while accomplishing the same goal. The new motor box 218 is vacuum formed in one piece instead of requiring the three pieces in my original unit. A plywood deck 219 is glued in the inside of the motor box 218 . This plywood deck 219 has pre-drilled holes with tee-nuts installed to provide a solid method of attaching the gear motor and other parts. In use of the machine, a patient first positions upper body pad 14 . Foot support platform 20 is then positioned to accommodate the torso length of the patient. The patient lies supine on the table with head, shoulders and upper back resting on upper body pad 14 and lower back and buttocks resting on rollers 16 . The patient's feet are inserted under pre-positioned foot clamps 118 , with the bottoms of the feet pressed against foot plates 126 and the backs of the feet resting on heel rests 110 to comfortably secure the feet in position between the heel rests and foot clamps. The therapeutic treatment machine is then energized by turning the on-off switch “on” position. The motor rotates, driving the foot support platform 20 along frame sides 48 and 50 , supported and guided by slots in bearing blocks. Operation proceeds in the manner described above in connection with the description of the motor circuit. The weight or force exerted by the head, shoulders and upper back of the patient on the upper body pad 14 controls the frictional resistance to sliding developed between friction bearings and the angle stock and is equal in the forward and rearward direction. When the compression or tension force transmitted through the body of the patient by the reciprocating foot support platform exceeds the frictional force between the friction bearings and the angle stock, the upper body pad will slide along the table frame to relieve and prevent additional force from being carried by the body. Consequently the patient can control the magnitude of tension and compression forces applied by the therapeutic treatment machine by increasing or decreasing the amount of body weight applied to the upper body pad. The platform continues to cycle back and forth applying alternating compression and traction to the patient until turned off at the on-off switch or until an obstruction of foot support platform 20 activates a safety stop microswitch. During compression, posterior tilting of the pelvis takes place, decreasing lumbar lordosis, relaxing the posterior elements of the spine and compressing the anterior elements. During traction the pelvis tilts forward causing extension of the lumbar spine. The increase in lumbar lordosis causes compression of the posterior elements and traction of the anterior elements. When the treatment is concluded the machine can be partially dismantled for compact storage or ease of portability by removing legs 40 , T-bar 106 and foot plates 126 , and folding forward section 26 and rearward section 28 together. A timer is included in the circuitry to allow the user to preset a duration for traction-compression cycling. A microprocessor based controller can be used to program the nature and duration of treatment. Furthermore, a simple ice bath of conventional design can effectively be incorporated into the roller apparatus to provide further therapeutic action or alternatively, the rollers can be replaced by a temperature controllable waterbag having low sliding resistance to allow the patient's mid body to slide freely during compression and traction. The power to drive the reciprocating movement of the foot support platform can be provided alternatively by a conventional rack and pinion drive, a screw actuator, a hydraulic piston or a drive wheel. In addition the braking action exerted by the weight of the patient's upper body acting frictionally on the bearing pads can alternatively be provided by conventional mechanical, electrical or hydraulic brakes or by force exerted by the patient against handles attached to the frame. A preferred mode of operation of the present invention involves applying forces of equal magnitude during the compression and traction, or pushing and pulling, sequences. The magnitude of the compression and tension force applied to the patient's body depends on the force exerted on the upper body pad. Typically forces applied to the patient are in the range of ten to seventy pounds. In view of the foregoing it is apparent that the present invention provides a therapeutic treatment machine capable of applying alternating cycles of preselected degrees of compression and traction to the back and spinal column or to other portions of a patients body. The machine is adjustable to accommodate different torso lengths and allows the patient to control the duration, frequency and intensity of treatment. The sliding engagement between the patient and the upper body support pad combines ease of control and protection against the application of excessive forces. Safety step switches activated by any obstruction in the path of the reciprocating foot support platform prevent accidental injury to the patient or others and the use of stepped-down 12 volt AC converted to DC at the machine minimizes electrical risk. The fold-away nature of the hinged table and removable legs and T-bar allows the machine to portably accompany the patient to provide treatment while traveling. Inasmuch as the present invention is subject to many variations, modifications and changes in detail, it is intended that all subject matter discussed above or shown in the accompanying drawings be interpreted as illustrative only and not be taken in a limiting sense.

1a

This is a division of application Ser. No. 524,861, filed Aug. 19, 1983. BACKGROUND OF THE DISCLOSURE This invention relates generally to improvements in wheelchairs, and more particularly, to improvements in correctively, custom molded wheelchair seats which are adapted for growth of individuals using the wheelchair, and for quick release mounting between the seat and wheelchair. Heretofore, what may be described as beanbag type cushions have been utilized to form contoured impressions of the human body, as shown in U.S. Pat. No. 3,830,896. However, such contoured cushions have not included changes made in the impressions formed for providing corrective positioning to the individual for whom the molded cushion is formed. Likewise, the necessity for filling the beanbag after the individual has been positioned in the forming seat is negated by performing the shape of the backsupporting portion of the cushion while controlling the amount of negative air pressure therein. Multimember, modular seating systems for the handicapped have been previously developed, as shown in U.S. Pat. No. 4,234,228. However, the cushions, disclosed therein are not custom molded to fit the individual utilizing the seat, and the articulation provided for the chair is one of angular articulation between individual pads, rather than an expansive changeability in the chair. Such known articulated seating systems for wheelchairs have been very expensive, and have not provided a means for expanding the size of the seat, or the spatial relation between the buttocks-supporting portion and backsupporting portion thereof, to accomodate the rather rapid growth of children. As a result, it has hertofore been necessary, in many instances, to purchase an entire new seat, at a substantial expense, when the user undergoes a growth spirt which is so common with children. Therefore, a need has developed for an improved cushion seating arrangement for use in a wheelchair, and particularly one which provides for growth of the user without the necessity of making frequent major repurchases. It is therefore an object of the present invention, generally stated, to provide a new and improved custom molded seating apparatus for use in a wheelchair. BRIEF SUMMARY OF THE INVENTION The invention is directed to a removable seat for use on a wheelchair. The seat includes a seat frame having a substantially vertical backsupporting portion, and a substantially horizontal buttocks-supporting portion with cushion means mounted on the respective frame portion for providing a contoured body receiving surface. An invention resides in the improvement comprising means on the backsupporting portion for vertically adjustably positioning the back portion relative to the buttocks-supporting portion, and means on the buttocks-supporting portion for horizontally adjustably positioning that portion relative to the backsupporting portion. The invention is further directed to a method for forming an individually contoured corrective seat for use by a disabled person. The seat is of the type having a frame including a substantially vertical backsupporting portion, and a substantially horizontal buttocks-supporting portion hingedly connected thereto with each portion adapted to retain at least one resilient cushion-like member. The method comprises the steps of: positioning a human being on a seat-forming frame having back and bottom deformable bags positioned thereon with each bag including a mass of bead-like material therein in order to form impressions on the bags of the back and buttocks respectively of a human being; making corrective changes to at least one of said bags to shape the contour of same to provide for corrective positioning of the human being in the final contoured-corrective seat; evacuating air from the back and bottom bags respectively to interlock said bead-like material into a form retaining condition; forming a positive mold of the back and buttocks by applying a setable mastic material to the impressions on the bags and allowing same to set; positioning the positive to the mold in spaced relation to the back and bottom portions of the seat forming frame to define a cavity therebetween; and filling the cavity with a setable fluid material while allowing same to cure into correctively-contoured back and bottom cushions. BRIEF DESCRIPTION OF THE DRAWINGS The features of the present invention, which are belived to be novel, are set forth with particularity in the appended claims. The invention may best be understood from the following detailed description of a currently preferred embodiment thereof, taken in conjunction with the accompanying drawings, wherein: FIG. 1 is a perspective view of a contoured corrective seat assembly constructed in accordance with the present invention, as it appears mounted in a wheelchair. FIG. 2 is an exploded perspective view of the custom-contoured seat assembly shown in FIG. 1. FIG. 3 is a side-elevational view of the seat assembly of the present invention shown in FIG. 1. FIG. 4 is a front-elevational view of the seat assembly shown in FIG. 1. FIG. 5 is a perspective view of the seat frame with the cushions removed therefrom. FIG. 6 is an enlarged fragmentary elevational view of the lower left quick-connection coupling shown in FIG. 1 with portions cut away to show the seat retaining mechanism. FIG. 7 is a cross-sectional view taken substantially along lines 7--7 of FIG. 6. FIG. 8 is an enlarged fragmentary plan view of the chest support bracket shown in FIG. 2. FIG. 9 is a cross-sectional view taken substantially along lines 9--9 of FIG. 8. FIG. 10 is an enlarged fragmentary elevational view of the headrest mounting shown in FIG. 2. FIG. 11 is an enlarged fragmentary plan view of the headrest mounting shown in FIG. 2. FIG. 12 is a cross-sectional view taken substantially along line 12--12 of FIG. 10. FIG. 13 is a fragmentary detail view of a portion of the seat frame of FIG. 5 showing frame-bracket alignment and adjustability therebetween. FIG. 14 is a perspective view of the seat-molding frame and beanbag cushions positioned therein being preformed to accept the seating of an individual therein. FIG. 15 is a side-elevational view of the seat-molding frame shown in FIG. 14. FIG. 16 is a rear-elevational view of the seat-molding frame shown in FIG. 14. FIG. 17 is a perspective view of the seat-molding frame of the invention having an individual positioned thereon with the beanbag being shaped to the contour of that individual. FIG. 18 is a fragmentary-perspective view of the seat shown in FIG. 17 with seat-contour fixed and plaster-mold strips positioned thereover. FIG. 19 is a perspective view of the positive-mold impression formed by the plaster gauze strips. FIG. 20 is a perspective view of a trial-molded seat-shape formed of thermosetting plastic. FIG. 21 is a perspective view of one of the positive molds shown in FIG. 19 with a mold-frame surrounding same. FIG. 22 is a perspective view of the mold-frame shown in FIG. 21 with a vinal covering positioned over the mold-frame and having foam material being poured therein. FIG. 23 is a perspective view of the finished, custom molded cushions of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1-7, the improved, custom-formed wheelchair seat 25, constructed in accordance with the present invention, is shown mounted on a wheelchair 26 by means of a plurality of quick-connect trunnion mounts 27--27. Seat 25 includes a back-supporting frame 33, a buttocks-supporting frame 34, and a pair of L-shape hinge members 35, 36 which maintain the back and buttocks supporting frames in predetermined spatial relation to one another while providing for adjustable spatial and angular relation therebetween. The back-supporting frame 33 and buttocks-supporting frame 34 are made in predetermined stock sizes and may be identical or differ in size depending on the user's needs. Referring to FIG. 5, back-supporting frame 33 includes a generally planar rectangular back or web centersection 37 and opposed vertical flanges 38, 40, respectively, which extend forwardly at right angles from the opposed side boundaries of the central web 37. Each flange includes thereon toward the top thereof a substantially cylindrical trunnion 29, 29, extending laterally outwardly thereof for quick releasable connection to trunnion mountings 27--27, a plurality of aligned spatially related apertures 43--43, 44--44, respectively, provide for retaining the back-supporting frame to the respective hinges 35-36, respectively, by means of links 45--45 (only one shown) having like threaded apertures 46-47 therein for retaining threaded fasteners 68--68 therein. Additional aligned apertures 48--48, 49--49 and 50--50, forming a generally U-shape grid are adapted to retain other members, to be discussed in greater detail below, onto the frame. Lastly, the back-supporting frame flanges 38-40 each include a distal cushion-retaining rib 38a, 40a, respectively, extending 90 degrees inwardly from the forward edge of each flange. As a result of these features, the back-supporting frame 33 will maintain a back-supporting cushion positioned therein, be quickly releasably retained by trunnions 28-29 to a wheelchair frame, and be adjustably mounted in a desired spatial and angular relation to through hinges 35-36, a like shaped buttocks-supporting frame member 34. As also shown most clearly in FIG. 5, the buttocks-supporting frame 34, depending upon the needs of the user, may be identical or substantially similar in shape to the back-supporting frame 33. Frame 34 includes a central-rectangular, horizontally-positioned web section 52 vertical flanges 53, 54, extending from the opposed side edges thereof, and a pairs of ribs 55-56, extending inwardly from the top distal edges of flanges 53-54, respectively, for retaining a seat cushion positioned centrally therein. Each vertical flange 53, 54 has a laterally extending trunnion 28, 28, respectively, positioned near the front end of the flange, and a plurality of apertures 59--59 and 61--61, which are adapted to retain the lower portions of hinges 35 and 36 in predetermined adjustable spatial and angular relation to the back-supporting frame 33, the mounting between hinges 35, 36, and buttocks supporting frame is accomplished by threaded fasteners and links 45, shown in connection with the back-supporting frame 33. The series of spaced double rows of apertures 62--62, 63--63, and 64--64, roughly in a U-shape are utilized to mount arm rests and foot rests to the frame, as will be shown in more detail below. As shown most clearly in FIGS. 1-4, each L-shaped hinge 35, 36 (with hinge 35 shown for explanation) includes a horizontally-extending base 61 and a vertically-extending arm portion 62. Adjacent the distal end of the base 65 are a pair of arcuate slots 67a-67b, adjustably retained by threaded fasteners 67--67. Adjacent the distal end of the upwardly-extending arm member 66 are a second pair of arcuate slots 68a-68b, adjustably retained by threaded fasteners 68--68. An aperture 69 on L-shape hinge 35 may be used as s seat belt mounting, as shown in FIG. 3. The dual pivotal mounting of back-supporting frame 33 and the buttocks-supporting frame 34 with relation to hinges 25, 26, provides heretofore unknown amounts of flexibility and adjustability to the shape of the complete seat. Also, as shown in broken line in FIG. 3, the plurality of spatially related apertures 43, 44, on back-supporting frame 33, and 59, 61 on buttocks-supporting frame 34, allow movement of the vertical frame up and down and the horizontal frame inwardly and outwardly to provide a proper size and shape seat for a user, and for growth of an individual utilizing the seat. Referring to FIGS. 2, 4, 6, and 7, trunnion mounts 27, each include a conventional clamp 30 having dished or oval clamping surfaces which is adapted for selectably releasable fixed mounting to a conventional wheelchair or square-tubed stroller, linking member 31 rotatably mounted to clamp 30, and a quick-release connection composed of a threaded shaft 41, extending normally from link 31 and having a recess 41a on the distal end thereof into which the end of a trunnion 28-29 may be inserted and engaged, and an internally threaded collar 42 which, when extended over the recess 41a and into engagement with the base of trunnion 28, retains the trunnion in the recess. A knurled or otherwise roughened outer surface on collar 42, provides for hand maneuvering of same along the threads on shaft 41. The remainder of the seat of applicant's invention includes a custom-formed, back-supporting cushion, generally indicated at 70 and a custom-formed, buttocks-supporting cushion, generally indicated at 71, which removably mount in frame members 33, 34, respectively, and a plurality of peripheral items, including left and right thigh support-arm rest members 72, 73, respectively, which selectably mount onto either the buttocks-supporting frame member 34 or the back-supporting frame member 33, by means of pairs of articulated arm members 74-75, including a base 74a-75a which is adjustable affixable to either seat frame by common threaded fasteners retained through slots in the base, and a pad holding member 74b-75b which is adjustably, swingably mounted to the base in a manner similar to the swingable mounting of chest supporting member 86 discussed below. Each arm rest pad and pad holding member may be selectably released to swing upwardly out of the way of a path for transferring an individual in or out of the seat, and then returned to a body supporting position. The upper inwardly dished surfaces 72a, 73a, respectively, of the thigh support-arm rest members 72, 73, may be utilized to locate and rest the chair user's arm and elbow thereon while the sloped but substantially vertical side 72b, 73b of each respective arm support is utilized to support the thighs of the user, allowing each ingress and exit when the pads are not swung upwardly out of the way. With the extreme base of adjustability of the seat assembly of the present invention, the only tool required for adjustment is a wrench, and adjustments may be made in the field at the user's situs. Referring to FIGS. 7-13, other accessories mountable and demountable to the chair, in an adjustable manner similar to the arm rest members, include a neck-head brace assembly 78, including a contoured neck pad 80 thereon which is adapted to conform to the curvature of the user's neck and head-bottom. Pad 80 is moulded around a malleable frame (not shown) which is bendable to conform to the user's neck and head shape. Neck brace assembly 78 further includes an adjustable head-support mounting 81, which is retained on the back side of the back-supporting frame 33 by threaded fasteners 82--82 extending through mounting 81 and apertures 48--48 on frame 33 to be retained by link 83. An extension rod 82, which is adjustably pivotally mounted at 83 to the back of pad 80 and slidably and selectively, rotatably retained on the top of mounting 81 by clamp 84. The double row of apertures 48--48 and 81a-81a, with the spatial distance between apertures 81a being one-half the spatial distance between apertures 48 in both directions provide for abundant adjustability, both vertically and laterally. As shown most clearly in FIG. 13, by switching the alignment of apertures from the left vertical column to the right vertical column on mounting 81, the mounting may be adjusted laterally in increments one-half the width of the distance between apertures 48--48. As shown in FIGS. 1-5 and 8-9, a chest or body supporting member, generally indicated at 86, which is adjustably mountable on the back of frame 33, includes a curved cushion 87, which like neck support pad 80, includes a malleable frame (not shown), and an articulated mounting linkage 88-90 between the frame 33 and cushion 87. The L-shaped base 88 of the articulated mounting linkage includes a distal foot 88a, including a plurality of elongate mounting slots 88b, in FIG. 2, therethrough similar to those shown in connection with articulated arm rest supports 74-75. Base 88 is adjustably mounted to back supporting frame 33 by threaded fasteners and link 77 through apertures 49--49, 50--50 in a manner similar to the mounting of the previously noted accessory items. Mid-link 90 is mounted at one end to L-shape arm 88 by means of pivot pin 91 for horizontal pivotal movement, and is mounted at its opposing end to cushion 87 for rotational movement therebetween around pin 93 with angular adjustment between the cushion and link being variable by means of a cam 92, which is coaxial with and sandwiched between the cushion 87 and mid-link 90. A spring loaded stop mechanism 91a, mounted on mid-link 90 adjacent one end of pin 91, selectably, releasably engages apertures in a flanged sleeve 89, concentrically mounted with pin 91, to allow pivotal movement between base 88 and mid-link 90 when desired. The rotation of cam 92 relative to mid-link 90 approximates 180 degrees and is limited by a pair of arcuate slots 94--94 positioned through mid-link 90 surrounding an aperture for pin 93 in spatial relation thereto. Screws 95--95 mount into the back side of cam 92, ride in slots 94--94 and may be tightened into binding relation with the side edges of the slots when fixed positioning is desired. The opposed distal ends of slots 94--94 provide stops preventing further rotation between the cam 92 and mid-link 90. Pin 93 is threaded into cushion 87 at one of a plurality of threaded apertures to provide for rotational or fixed positioning therebetween and for length adjustment, as desired. Loosening screws 95--95 and/or cushion 87 from pin 93 allow the cushion 87 to be rotated until the fit of the cushion against the user is proper and comfortable. Then, the screws may be turned to fix the cushion 87 and cam 92 relative the mid-link 90. Referring to FIGS. 1-5, a pair of adjustable foot rests 96--96 are mounted by the afore-disclosed threaded fasteners and links (not shown) fastened through apertures 64--64 adjacent the front of buttocks-supporting frame 34 so as to depend therefrom. Each foot rest 96 includes an adjustable triangulated base 97 which is hinged at its corners and has overlapping distal ends forming the hypotenuse thereof. A plurality of apertures 97a are positioned all along the base for providing adjustability to the foot rest. A stirrup 98 is mounted on the front of base 97 by conventional fasteners and, as a result of the multitude of apertures 98a on the stirrup and base, is adjustable in its vertical positioning. By lessening or increasing the overlap of the distal ends of base 97, stirrup 98 may be moved arcuately for user's comfort as desired. The corners of triangulated base 97 are held together by push pins 99 to provide ease of disassembly and adjustment. Thus, the new and improved quickly mountable-demountable seat of the present invention has been shown and described as it mounts onto a wheelchair of conventional manufacture. Referring to FIG. 23, and more generally to the method disclosed in FIGS. 14-23, the improved seat of the present invention includes a custom-formed, back-support cushion 60 having a generally rectangular outline sized for being press fit into the back-supporting frame 33. Each cushion has an outer frontal surface 127, preferably formed of a vinyl material, which is heated and stretched into the desired shape to provide a seamless cushion cover. The bulk of the cushion is made of polyurethane foam which is poured into the desired shape and expands and sets to produce the custom-moulded cushions 60 and 61 in the shapes desired, as will be disclosed more fully hereafter by explanation of the preferred method of moulding means. When custom moulding the seat cushions 60-61, a bean-bag type moulding apparatus, generally indicated at 100, is used. It includes a back-support moulding frame 101, a buttocks-support moulding frame 102 positioned in slidable and angularly adjustable spatial relation thereto, with both being adjustably mounted on a linkage controlled mounting platform 103. In a manner functionally similar to the living hinges 35, 36 discussed previously, hinge mechanisms 104, 105 (only one shown), provides adjustable angular and lateral positioning of the back-support moulding frame 101 and the buttocks-support moulding frame 102. The back-support moulding frame 101 and buttocks-support moulding frame member 102 are slightly larger than the largest of the stock size cushions made in accordance with the present invention which will fit in commercial wheelchairs. Cushions may be made smaller than the framework of the present invention by cutting the size of the mould made in the frame, as will be described in more detail below. A first bean-bag 106, in this embodiment preferably formed of latex with polyethylene beads (not shown) therein, is mounted on the back-support moulding frame 101, and likewise, a second bean-bag 107, made of identical materials, is mounted horizontally in the buttocks-support moulding frame 102. A vacuum system includes a manifold 108 mounted on frame platform 103 and having a first vacuum line 110 in fluid communication with the interior of first bean-bag 106. The pressure inside first bean-bag 106 is controlled by a vacuum generator (not shown) which is attached through air line 111 to manifold 108, and a first control valve 112 in line 90. Likewise, a second vacuum line 113 is connected between manifold 108 and second bean-bag 107 and includes a second control valve 114 therein. With both moulding frames positioned nearly horizontal, a partial vacuum is drawn through manifold 108 and line 90 into the back-support bean-bag 106. As shown in FIG. 14, once a partial vacuum is achieved, the polyethylene beads in the bag are moved or maneuvered by hand to a position of rough approximation of the cavity desired for the seat user. The amount of vacuum in the bag 106 may be controlled by valve 112 (at about one-half inch Hg) to make the polyethylene beads in the bag 106 highly moveable when the preforming operation begins, and with a vacuum of about 3 inches Hg, the bean bag becomes hard and immobile. Likewise, valve 114 is utilized to control a partial vacuum in bean-bag 107 to rough form the bag to the approximate shape of the user, as shown in FIG. 16, cutouts 101a--101a in the web of back-support moulding frame 81 allow adjacent portions of the bean-bag to be pushed outwardly to aid in properly fitting the bag to the trunk area of the user. As shown in FIG. 17, after the preforming has been completed, the frame 101 is positioned vertically as desired, and an individual for whom custom-molded seat cushions are to be made, is seated on the bean-bags 106, 107. The hands of the moulder, the weight of the proposed cushion user, and control valves 112-114 are all utilized to move the polyethylene beads in the latex bean-bags 86, 87, to ideally fit the shape of the user. After proper fit has been obtained, any desirable corrective shaping of the cushions is made by the moulder and the corrective shaping may be tested on the proposed user, as desired. Once a proper shape for the proposed cushions has been obtained, the control valves 112-114 are adjusted to a vacuum approximating 3 inches Hg, which hardens the bean-bags 106-107 to prevent additional shape change. Thereafter, the individual for whom the cushions are to be made is lifted off of moulding frame 100 and bean-bags 106 and 107. As shown in FIG. 18, plaster impregnated gauze strips 115, 116, are wetted and laid on the bean-bags to make a positive mould of the desired shape of the proposed seat cushion. After the gauze strips 115, 116, are allowed to harden, a positive mould such as that shown at 117, 118, in FIG. 19, is lifted off of the bean-bags. If additional corrective changes need be made to positive moulds 117, 118, or if it appears their shape should be changed for any reason, plaster material may be added to or substracted from the positive moulds as desired, such as, by removal of or addition of materials to areas denoted in circular outline at 120 and 121 on positive moulds 117, 118. It should be noted that it is the back sides (not shown) of mould positive 117 and mould positive 118, which are utilized as the surfaces which the contour of the custom-made cushions will follow. It should be noted that as shown most clearly in FIGS. 14-18, the latex surface of bean-bags 106-107, together with the polyethylene beads thereunder, may, when the bags are drawn to a high vacuum, have a bead-textured surface. This textured surface will translate directly to the positive moulds 117, 118. As the positive mould shells 117, 118, are made of plaster held together by gauze, the back-side surface may be sanded or otherwise worked to provide a smooth surface for the cushions to be made on. Referring to FIG. 20, a trial surface for the proposed custom-fitted cushions may be made by laying a heated sheet of thermoplastic material over the back side of mould positives 117, 118 and allowing same to cool. Thus, trial shape back-support member 122 and buttocks-support member 123 may be formed and held together by mounting 124. If the intended user of the cushions is not located in the immediate geographic area where the cushion-making process is taking place, the trial shels 122, 123 may be shipped inexpensively to any location to determine if the proposed seat shape is proper. As the individual is seated in the trial-shape seat 122, 123, any necessary changes may be noted and corrections thereafter made on the mould positives 117, 118, as necessary The trial seat also has another use, as mounting cups (not shown) or other base materials may be affixed to the shell bottom and the seat may be utilized as a bathing seat for the user of the cushions. As shown in FIGS. 21 and 22, the back-side of a mould positive 125, which is similar to the mould positive 117, 118, disclosed previously, has been cut to a desired rectangular size and thereafter encircled or placed into a frame 126 having depth which is at least the desired depth of the cushion to be made. A sheet of vinyl material 127 is heated and vacuformed inside-out over the back side of the plaster positive 125 and framing material 125 until it conforms to the desired cushion shape and outline. The material extending over the frame may be utilized to protect the frame from any spills or mess-making procedures. As shown in FIG. 22, polyurethane foam 138 is then poured into the frame 126 to a desired depth. It should be noted that the foam expands as it sets and will rise a certain extent. The poured fluid seeks all of the corners and cavities of the mould during the filling process. When the polyurethane foam completely sets, the excess vinyl sheet material 107 is trimmed and one of the custom-formed, seat cushions is completed and appears as shown at 60 and 61 in FIG. 23, the cushions may be press fit into the respective back-supporting frame 33 and/or buttocks-supporting frame 34 of the custom-formed seat 30 of the present invention. One of the advantages of the seat of the present invention is the expansibility of the seat lengthwise to accommodate growth of the individual for whom the seat is designed, and the expansibility of the seat both lengthwise and widthwise by the relatively inexpensive replacement of one or both custom-formed cushions 60-61, and one or both seat frames if necessary, in the event the individual outgrows the first formed cushions. The custom moulding of second or additional cushions is considerably less expensive than the procurement of a complete new seat should the individual outgrow the seat as originally moulded. Additionally, the custom moulding of seat-back support and buttocks-support cushions provides for substantial surface contact between the individual and the seat, thus minimizing pressure sores, which have heretofore been pronounced where point or small area contact between the user and the seat has been found. Also in one of the most important features of the present invention, the adjustability and custom forming of the seat assembly places the users in a functional position, which is extremely important in cases of severe deformity. The custom-formed seat of the present invention is affixable to various commercial wheelchairs, such as, those sold under the trade marks Everest and Jennings, and Invacare and Stainless Wheelchairs, as well as McLaren and Pogon Strollers. While one embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art, that changes and modifications may be made within the scope of the present invention. Therefore, it is the aim in the appended claims to cover all such changes and modifications as fall within the true spirit and scope of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This patent document is a continuation-in-part of U.S. Ser. No. 13/658,946, filed on Oct. 24, 2012, which is a continuation of U.S. Ser. No. 13/069,142, filed on Mar. 22, 2011, which is a continuation of U.S. Ser. No. 12/102,638, filed on Apr. 14, 2008, now U.S. Pat. No. 7,946,249, granted on May 24, 2011, which is a non-provisional of U.S. Ser. No. 60/911,941, filed on Apr. 16, 2007, the entire contents of which are incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present patent document relates to bottle type bird feeders, namely nectar feeders for birds. The nectar feeder of the present invention contains a float and a valve which together regulates the flow of nectar feed from a container and into a base tray. The float and valve either prevent or allow the flow of nectar feed depending upon the volume of nectar feed contained in the base tray. 2. Background of the Related Art In the prior art, typical hummingbird feeders include an enclosed base tray for housing the liquid feed nectar therein. A number of feed ports are provided through the top base cover of the base tray so a bird may gain access to the liquid feed therethrough. Typically, the feed ports are small in diameter to simulate an actual flower in the field. There is a periodic need to re-fill the base tray of the feeder with the liquid feed when the supply is low or completely out. In the prior art, an inverted vacuum-type bottle is commonly employed to supply the liquid into the main chamber of the base tray of the feeder to provide a continuous supply of feed for consumption by the hummingbirds. In the prior art, a bottle, in similar configuration and size to a baby bottle is typically used. However, larger or smaller bottles may be used. The bottle has a bottom closed end and a top open end which has male threading thereon. A complementary female threaded aperture is provided in the top base cover of the base tray of the feeder to receive the open threaded end of the reservoir. The reservoir, with liquid feed therein, supplies liquid into the base tray of the feed for access by the hummingbirds. Since the bottle has a closed top end, a vacuum is created thus controlling the downward flow of liquid as the hummingbird feeds from the feeder. As liquid is drained from the reservoir, bubbles will rise in similar fashion to a common drinking water bubbler. Due to presence of high sugar content in hummingbird nectar, which results in accumulation of solids and growth of mold inside the bottle and base tray, cleaning of the prior art feeder must be frequent to maintain a desirable level of performance. Such frequent cleaning is considered by many users to be difficult for several reasons. For example, the users must use a variety of brushes that can fit into the small mouth of the bottle to clean the interior. Cleaning the prior art bottle feeders using a rag or sponge is generally impractical. In this prior art construction, the base tray of the feeder must be inverted, when threadably receiving the bottle that contains the new supply of liquid feed, to avoid spilling of the liquid. If the base tray of the feeder is not inverted, the liquid will spill until the bottle was threadably secured to the top base cover of the base tray of the feeder. Inverting the base tray portion of feeder is undesirable because any remaining liquid feed still in the base tray will leak out making the installation of the bottle messy. This is particularly messy if a substantial amount of liquid feed remains in the base tray of the feeder. Accordingly, there is a need for a nectar feeder that provides a mechanism for providing nectar feed without inverting a bottle or the base tray of the feeder. There also remains a need for a nectar feeder that provides access for easy refilling of the nectar feeder without spilling the nectar. Also, there remains a need for a nectar feeder that is easy to clean. There is a further need to better control the flow and delivery of nectar. BRIEF SUMMARY OF THE INVENTION An embodiment of the present invention preserves the advantages of prior art bottle type nectar feeders. In addition, it provides new advantages not found in currently bottle type nectar feeders and overcomes many disadvantages of such currently available type nectar feeders. The embodiment is generally directed to a novel and unique nectar feeder. The nectar feeder of the present invention contains a float and a stopper having a substantially flush top, which together regulates the flow of nectar feed from a spout of a container and into a base tray. The float and stopper either prevent or allow the flow of nectar feed from the spout on the container depending upon the volume of nectar feed contained in the base tray. BRIEF DESCRIPTION OF THE DRAWINGS The novel features which are characteristic of the nectar feeder are set forth in the appended claims. However, the nectar feeder, together with further embodiments and attendant advantages, will be best understood by reference to the following detailed description taken in connection with the accompanying drawings in which: FIG. 1 is a perspective view of the bird feeder in accordance with the present invention; FIG. 2 is an exploded view of the bird feeder of FIG. 1 ; FIG. 3 is a perspective view of the bird feeder of FIG. 1 with the lid in an open position; FIG. 4 is a top view of the bird feeder of FIG. 1 ; FIG. 5 is a cross-sectional view of the bird feeder of FIG. 1 cut along line 3 - 3 ; FIG. 6 is a partial front view of a bird feeder of FIG. 1 ; FIG. 7 is a partial side view of the bird feeder of FIG. 1 ; FIG. 8 is a front perspective view of the bird feeder of FIG. 1 with the float raised to prevent the flow of liquid feed into the base tray; and FIG. 9 is a front perspective view of the bird feeder of FIG. 1 with the float lowered to allow the flow of liquid feed into the base tray. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is a nectar feeder 10 as shown in FIGS. 1-9 . The nectar feeder 10 contains a float 120 and a stopper 130 which together regulate the flow of nectar feed 160 a container 20 and into a base tray 30 . The float 120 and stopper 130 either prevent or allow the flow of nectar feed 160 depending upon the volume of nectar feed 160 contained in the base tray 30 . Moreover, the nectar feeder 10 allows the nectar feed 160 to be poured directly into the container 20 of the feeder 10 which obviates the need to detach the container 20 each time the feeder 10 needs to be refilled. This avoids the mess associated with refilling nectar feeders of the prior art. Referring to FIG. 1 , the nectar feeder 10 of the present invention is shown. An exploded view of the present invention of FIG. 1 is shown in FIG. 2 . The nectar feeder 10 includes a container 20 for storing nectar feed 160 , the base tray 30 and the float 120 containing the stopper 130 . The container 20 is attached to the base tray 30 and is in fluid communication with the base tray 30 . The float 120 containing the stopper 130 is positioned between the 20 and the base tray 30 . When the nectar feed 160 flows through the container 20 and into the base tray 30 , the float 120 rises until the stopper 130 prevents nectar feed 160 from flowing through the container 20 and into the base tray 30 . By having the float 120 and stopper 130 regulate the flow of nectar feed 160 , the nectar feeder 10 requires less maintenance, reduced spillage of nectar feed 160 , and self-regulation of the nectar feed 160 . Details of the stopper 130 construction are discussed in detail below. Referring to FIG. 2 , the container 20 has a top end 22 and a bottom end 24 in which both ends of the container 20 have at least one thread ( 21 , 20 A, 20 B) positioned thereupon in different locations. The container 20 has a volume sufficient to hold enough nectar feed 160 to fill the base tray 30 and, as a result, allow the float 120 to rise. In one embodiment, the container 20 defines a shape of a bottle. However, it should be noted that the container 20 may define shapes other than a bottle type shape. It should also be noted that a design or shape other than a bottle may be used for the present invention. The bottom end 24 of the container 20 is partially closed off and it defines a spout 149 with at least one exit port 150 ( FIG. 7 ), which may be tapered, for nectar feed 160 to exit the container 20 into the base tray 30 . In a preferred embodiment, there is one exit port 150 but alternative embodiments may contain two or more exit ports 150 . It should be noted that the size of the exit port 150 may be adjusted according to the viscosity of the liquid and the desired flow rate of the nectar feed 160 from the container 20 to the base tray 30 . The container 20 is removably attached to the base tray 30 . In a preferred embodiment, the container is threadably attached to the base tray 30 . More importantly, the container 20 is attached without first inverting the container 20 or the base tray 30 . The benefit is that the container 20 maintains an upright or vertical position during refilling which is easier and prevents spillage of nectar feed 160 . It should be noted that alternative methods known in the art for attaching the container 20 to the base tray 30 are also suitable. For example, the container 20 may be fixedly attached to the base tray 30 without the use of threads. Referring to FIG. 3 , the top end 22 of the container 20 has a cap 50 which is attached to the top end 22 of the container 20 . In one embodiment, the cap 50 is threadably attached to the top end 22 of the container 20 . The top end 22 of the container 20 is open and has at least one thread 21 positioned on an inner surface of the top end 22 . The cap 50 is easily removed to allow full access to the interior of the container 20 for cleaning It should be noted that other methods for attaching caps to containers may be used other than threads. For example, the cap 50 may be fixedly attached to the container 20 using adhesives or other fasteners. A lid 60 is, for example, hingedly connected to the cap 50 . The hinge 70 allows the lid 60 to be opened and closed for easier refilling of the container 20 . The lid 60 , when in an open position ( FIG. 3 ), allows a user to refill the container 20 with nectar feed 160 without having to invert the container 20 or base tray 30 . The lid 60 , when in a closed position ( FIG. 1 ), prevents unwanted insects and debris from gaining access to the nectar feed 160 in a reservoir 170 of the container 20 . In addition, the lid 60 has a finger tab 80 to facilitate manipulation of the lid 60 from an open position ( FIG. 3 ) to a closed position ( FIG. 1 ). It should be noted that the lid may be removably attached to the top of the container 20 in ways other than a hinged connection. Referring to FIG. 4 , the base cover 40 has a support 100 or perch extending from an upper surface of the base cover 40 . The raised support 100 , in one embodiment, is a raised peripheral support 100 attached by six support arms ( 100 A- 100 F) to the base cover 40 . It should be noted that the raised support 100 may extend from various portions of the base cover 40 besides the periphery. The support 100 allows birds to rest while feeding on nectar feed 160 through a feed port ( 90 A- 90 F). The base cover 40 , as mentioned above, also contains at least one feed port 90 A- 90 F which are defined through the base cover 40 . The feed ports 90 A- 90 F are respectively positioned over the nectar 160 so that feeding birds are aligned thereover for optimum access to the nectar 160 therein. It is contemplated that the feed ports 90 A- 90 F may be positioned anywhere on the base cover 40 so long as the float 120 does not prevent access to the nectar feed 160 within base tray 30 . The feed ports 90 A- 90 F are preferably configured to appear as flowers, or other structures, to further attract birds to the feeder 10 . The feed ports 90 A- 90 F are respectively positioned above the base tray 30 so that feeding birds are aligned thereover for optimum access to the nectar feed 160 therein. Referring to FIG. 5 , a base cover 40 is attached to the container 20 . The base cover 40 defines a base cover hole 44 for receiving the lower periphery 25 of the container 20 . An inner periphery of the base cover hole 44 forms at least one thread 40 A, preferably partial thread, for threadably engaging at least one thread 20 A, preferably partial thread, on the lower periphery 26 of the container 20 . It should be noted that other methods for attaching the base cover 40 to the container 20 may be used other than threads. For example, the base cover 40 may be fixedly attached to the container 20 using adhesives or other fasteners known in the art. Referring to FIG. 6 , a base tray 30 has a top surface 30 A and a bottom surface 30 B. The top surface 30 A has a wall 31 raised along a periphery of the top surface 30 A of the base tray 30 . The wall 31 has sufficient height to contain the nectar feed 160 therein. In a preferred embodiment, the width of the base tray 30 is greater than the height of the base tray 30 . The base tray 30 contains at least one vertical member 32 , 34 extending from the top surface 30 A of the base tray 30 . In a preferred embodiment, the base tray 30 contains two vertical members 32 , 34 which are mirror images of one another and arc-shaped. However, more than two vertical members may be used. It is contemplated that the vertical members 32 , 34 may be integrally formed within the base tray 30 or may be attached by means known in the art. Referring to FIGS. 2 , 6 and 7 , the container 20 has an upper periphery 25 and a lower periphery 26 with at least one thread ( 20 A) on an outside surface of the lower periphery 26 . In a preferred embodiment, the lower periphery 26 has one thread 20 A on the outside surface of the container 20 for threadably engaging with at least one thread ( 34 A, 32 A) on the vertical members 32 , 34 of the base tray 30 and at least one thread 40 A on an inner periphery of the base cover 40 respectively. In addition, the threads ( 34 A, 32 A) on the base tray 30 and the thread 40 A on the base cover 40 allows for easy removability and makes it easier cleaning or replacement of worn components of the nectar feeder 10 . Cleaning the components of the nectar feeder 10 is essential to preventing any contamination of the nectar feed 160 which may become harmful to birds if not maintained properly. The vertical members 32 , 34 may be configured to receive less than the total surface area of the bottom end 24 . For example, a first vertical member 32 may provide a seat for less than 180 degrees of the circumference of the bottom end 24 of the container 20 . A second vertical member 34 , which is a mirror image of the first vertical member 32 , may also provide a seat for less than 180 degrees of the circumference of the bottom end 24 of the container 20 . When the bottom end 24 of the container 20 rests within the middle portions 32 B, 34 B of the vertical members 32 , 34 , it provides sufficient support to hold the container 20 in a vertical position. The benefit of holding the container 20 in a vertical position is that it prevents the spillage of nectar feed. The vertical members 32 , 34 also have a top portion 32 A, 34 A for threadably engaging the thread 20 B located on the lower periphery 25 of the container 20 . In a preferred embodiment, two vertical members 32 , 34 have a partial thread located on an inner surface of the top portion 32 A, 34 A to cooperate together to provide a female threading. The two vertical members 32 , 34 threadably attaching to at least one thread 20 B located on the lower periphery 25 of the container 20 . It should be noted that the container 20 may be attached to the vertical members 32 , 34 by structures or mechanisms other than threads. For example, the container 20 may be fixedly attached to the vertical members 32 , 34 using adhesives or fasteners although this is not preferred. A float 120 is positioned between the bottom end 25 of container 20 and the base tray 30 . The float 120 defines a circular shape with an outer circumference suitable for resting within the base tray 30 . The float 120 is constructed and made of material that provides buoyancy in the presence of nectar feed 160 . The float 120 is preferably made of plastic material which is easy to clean. It can be a sealed hollow member with air trapped therein. Most importantly, the float 120 is sized to permit a bird to retrieve nectar feed 160 through the feed ports 90 A- 90 F without interference from the float 120 . The float 120 is respectively positioned below the base cover 40 which has feed ports 90 A- 90 F defined therethrough. When the bird retrieves nectar feed 160 through the feed ports 90 A- 90 F, there must not be any obstruction from blocking access to the nectar feed 160 . If the feeder ports 90 A- 90 F are positioned proximal the peripheral raised support 100 , the float 120 should have at least have a diameter less than the base tray 30 . The diameter of the float 120 should also accommodate the feed ports 90 A- 90 F to prevent any interference by the float 120 with the bird feeding on the nectar 160 through the feed ports 90 A- 90 F. Alternative configurations of feed ports 90 A- 90 F may necessitate additional shapes or changes in the float 120 to accommodate the direct access of the nectar feed 160 to the birds. The float 120 defines at least one float hole 120 A, 120 B through the float 120 for slidably engaging the vertical member 32 , 34 . In a preferred embodiment, there are two float holes 120 A, 120 B. The float holes 120 A, 120 B are keyed to an outer profile or shape of the vertical members 32 , 34 to prevent independent rotation of the float 120 in any direction. Of course, the float holes 120 A, 120 B may be adjusted to define a shape similar to the overall shape and design of the vertical members 32 , 34 . To facilitate the slidably engagement of the float 120 with the vertical members 32 , 34 , the float 120 has a thickness less than the depth of the base tray 30 . Also, the height of the float 120 is less than the height of the vertical members 32 , 34 . The float 120 contains a stopper 130 with a flat to surface, which may be incorporated together in a single structure. However, it should be noted that valves other than stoppers or sealing-type plugs may be used for the present invention. The stopper 130 is seated in a stopper seat 140 on a central portion of the float 120 . The stopper seat 140 is either integrally formed or attached to the central portion of the float 120 . The stopper 130 rests within the stopper seat 140 . When the float 120 rises due to the filling of an interior of the base tray 30 with nectar feed 160 , the stopper 130 engages the spout 149 and closes off the exit port 150 to prevent the flow of nectar feed 160 through the exit port 150 and into the base tray 30 . As shown along vertical axis B, the stopper 130 is respectively positioned below the exit port 150 on the bottom end 25 of the container 20 . Because the top surface of the stopper 130 is flat and relatively larger compared to the preferably tapered spout 149 and exit port 150 , a sealing engagement between the stopper 130 and spout 149 is improved if the nectar feeder 10 is canted, tipped or the float 120 is otherwise not aligned squarely on the spout 149 . The stopper 130 and the exit port 150 can be adjusted according to the dimensions and quantity of each. Referring to FIG. 8 , in operation, a user opens the lid 60 ( FIG. 3 ) and fills (or refills) the container 20 with nectar feed 160 . There is no need to invert the container 20 to refill which is a substantial advantage over the prior art. When the container 20 is sufficiently filled with nectar feed 160 , nectar feed 160 begins to accumulate inside the container 20 . When the volume of the nectar feed 160 is sufficient, the nectar feed 160 gradually begins to flow through the exit port 150 of the spout 149 and into the base tray 30 . As the base tray 30 fills with nectar feed 160 , the float 120 begins to rise in correlation to the volume of nectar feed 160 occupying the interior of the base tray 30 . When the base tray 30 fills with nectar feed 160 , the float 120 gradually rises thus forcing the stopper 130 to sealingly engage the exit port 150 on the spout 149 located on the bottom end 25 of the container 20 . When the base tray 30 is substantially full, the float 120 will further rise to sealingly engage the stopper 130 within the exit port 150 of the spout 149 , which prevents the further flow of nectar feed 160 through the exit port 150 of the spout 149 . When the exit port 150 is completely blocked by the stopper 130 , the nectar feed 160 is prevented from moving through the exit port 150 and into the base tray 30 . As a result, leakage or overflow of the nectar feed 160 , such as through the feed ports 90 A- 90 F, is prevented. In addition, the nectar feed 160 is preserved inside the container 20 and used when necessary to refill the base tray 30 . If any contamination occurs inside the base tray 30 , it does not contaminate the nectar feed inside the reservoir 170 of the container 20 . A user can clean the base tray 30 , when it has contaminated nectar feed 160 , without impacting the entire supply of nectar feed 160 inside the container 20 . Referring to FIG. 9 , during the normal course of use of the nectar feeder 10 , the nectar feed 160 is consumed by the birds through the feeding ports 90 A- 90 F. When the birds consume the nectar feed 160 , the nectar feed level in the base tray 30 drops. As the nectar feed 160 is depleted from the base tray 30 , the float 120 will eventually drop or lower thus taking upward pressure off the stopper 130 to permit the entry of additional nectar feed or other liquids into the base tray 30 . As a result, the float 120 disengages the stopper 130 from the exit port 150 to once again allow the flow of nectar feed 160 to flow into the base tray 30 . The feeder 10 permits the easy and convenient refilling of the feeder 10 even if the container 20 is not completely empty. By allowing nectar feed 160 to be flow directly from the container 20 and into the base tray 30 , there is no disassembly required for eventual refilling of the base tray 30 by the container 20 . This is a continual and gradual process until the nectar feed 160 is completely depleted from the container 20 . Furthermore, as seen in FIGS. 1-3 , a hanger 110 is also attached to the cap 50 for securing the nectar feeder 10 to a stationary object. The hanger is an example but there are other structures or mechanisms for securing the nectar feeder 10 to another object may also be used. For example, suction cup mounts, wall mounts, and post mounts may also be used and attached to the cap 50 or other components of the nectar feeder 10 . In one embodiment, the nectar feeder 10 is made of materials known in the art. Preferably, the nectar feeder 10 is made of plastics. Various colors of the plastics may be used to attract birds to the present invention. Structures or mechanisms other than threads may be used to attach the components of the nectar feeder 10 . In view of the foregoing, a new and novel improved nectar feeder 10 is provided for easy and efficient refilling. The present invention contains a float 120 and stopper 130 which regulates the flow of nectar feed 160 through the container 20 and into the base tray 30 . More specifically, a container 20 is attached to the base tray 30 and in fluid communication with the base tray 30 . The float 120 contains the stopper 130 which is positioned between the container 20 and the base tray 30 . When the nectar feed 160 flows through the container 20 and into the base tray 30 , the float 120 rises until the stopper 130 prevents nectar feed 160 from flowing through the container 20 and into the base tray 30 . The nectar feeder 10 of the present invention can also be filled without inverting the base tray 30 or container 20 which conserves the nectar feed. In addition, the nectar feeder 10 is easier to clean than prior art nectar feeders due to the removability of various parts. Therefore, while there is shown and described herein certain specific structure embodying the invention, it will be manifest to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to the field of dishwashers and specifically to a controller for a dishwasher having alternating liquid flow to spray arms. 2. Description of the Related Art Washing machines, particularly dishwashers, often have two or more spray arms for directing washing liquid at objects to be washed. Typically, a lower spray arm is located near the bottom of a wash tub and an upper spray arm is located in a middle area or near the top of the wash tub. A pump is provided to deliver liquid from a sump in the bottom of the tub to the spray arms. Commonly, the liquid is delivered simultaneously to both spray arms in more or less equal amounts. U.S. Pat. Nos. 4,741,353 and 5,264,043, both to Milocco and incorporated herein by reference, show and describe an apparatus and method for alternating liquid flow between the spray arms. A specialized ball valve switches flow from one arm to the other when operation of the pump is interrupted for a certain amount of time. The Milocco references show a programmed electronic controller for operating the pump to achieve proper operation of the valve. It would be desirable to use an electromechanical controller for such an apparatus because of the inherent simplicity and reliability. Electromechanical controllers for dishwashers are well known, as shown, for example, in U.S. Pat. Nos. 2,771,894; 2,825,665; 3,199,525; 3,439,687; 3,440,399; 3,835,880; 4,159,211; 4,559,959 all incorporated herein by reference. Typically these controllers have a cam wheel defining a plurality of coaxial cam disks each adapted to operate one or more switches. The switches are connected to control different machine functions. The cam wheel is driven by a timer motor. In some installations, the controller is provided with an auxiliary cam wheel to control a specific function of the washer. For example, the auxiliary cam can be connected to control a water valve to provide a brief (about 11 seconds) inlet of water to purge the sump of dirty water at the end of a washing operation. Such controllers are simple, reliable, and adequate for most dishwashing functions. Therefore, it is desirable to adapt an electromechanical timer to control the short and precise lobes required for the Milocco ball valve. SUMMARY OF THE INVENTION The present invention provides washer with two sprayers for spraying fluid and a pump for delivering fluid to the sprayers. A valve controls flow from the pump to the sprayers to alternate fluid flow between the sprayers. A controller is adapted for stopping and starting the pump thereby controlling the valve to alternate flow of fluid to the sprayers. The controller includes a switch connected to energize the pump and a first timer wheel adapted to operate the switch so as to energize the pump for a certain period of time. A second timer wheel is adapted to override the first timer wheel to operate the switch to deenergize the pump for a certain period of time. Preferably, the valve comprises a ball adapted to block one of two conduits in communication with respective sprayers. The valve is adapted to move the ball from one conduit to the other when water flow to the valve is interrupted. A second switch is connected in parallel with the first switch and adapted to operate the pump regardless of the state of the first switch. The controller also includes a timer motor adapted to rotate the timer wheels. The timer wheels are rotatable cam wheels and a cam follower mounted on the switch is operated by the first timer wheel. A lever is operated by the second timer wheel and disposed to open the switch. An appendage mounted on the switch is operated by the lever. The switch comprises a pair of spring arms having electrical contacts adapted to close a circuit. Thus, the invention provides a simple and reliable washer adapted to alternately spray water from upper and lower spray arms. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a schematic front elevation of a dishwasher according to the invention; FIG. 2 shows a schematic diagram of an electrical circuit according to the invention; FIG. 3 shows a rear isometric view of a controller according to the invention; FIG. 4 shows a front elevation of the controller in a section taken from line 4--4 of FIG. 3; FIG. 5 shows a front elevation of the controller in a section taken from line 5--5 of FIG. 3; and FIG. 6 shows a timing diagram for operation of selected switches and a pump of the dishwasher. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, a washer, such as a dishwasher 10, includes a wash tub 12 for containing objects to be washed. A lower part of the tub 12 defines a sump 14 for collecting washing liquid, such as a solution of water and detergent. A pump 16 driven by a motor 18 is located in communication with the sump 14. The pump 16 is adapted for delivering liquid to an upper spray arm 20 and a lower spray arm 22 through suitable conduits 24. The spray arms 20, 22 spray liquid on the objects in the tub 12. A valve 26 is disposed between an outlet of the pump and the conduits 24. The valve 26 includes a ball 28 for alternately blocking each of the conduits 24 to limit liquid flow to one of the spray arms 20, 22 at a time. Such a valve is described in detail in U.S. Pat. No. 4,741,353 to Milocco. Interruption of a flow of liquid from the pump 16 through the valve 26 causes the ball 28 to change position from blocking one conduit to blocking the other conduit. When flow resumes, liquid is delivered to the other spray arm. Thus, as described below, proper control of liquid flow from the pump 16 causes alternating flow from the spray arms 20, 22. A controller 30 is connected to the pump motor 18 to achieve the desired liquid flow. Referring to FIG. 2, the controller 30 is connected between the pump motor 18 and a power source 32 such as a household alternating current supply. The controller 30 includes a door switch 34 that is normally closed when a door closing the tub 12 is closed and locked. A rinse cycle selector switch 36 and a wash cycle selector switch 38 are connected in parallel with each other and in series with the door switch 34. The rinse cycle selector switch 36 is closed for a "rinse & hold" and a "pots & pans" washing operation. The wash cycle selector switch 38 is closed for a "normal wash" and the "pots & pans" washing operation. A first bus switch 40 and a second bus switch 42 are connected in series with respective cycle selector switches 36, 38. The bus switches 40, 42 are normally open. The first bus switch 40 is closed during a pre-rinse period and the second bus switch 42 is closed during the remaining period of operation. Other combinations of cycle switches and bus switches for controlling other cycles are also suitable and well known in the art. A motor switch 44 is connected in series with the bus switches 40, 42. The motor switch 44 is normally closed and is opened to deenergize the motor and also during interrupted operation of the motor to achieve alternating flow of liquid to the spray arms 20, 22, as discussed below. A drain switch 46 is connected in series with the motor switch 44. The drain switch 46 is normally closed and operates the pump motor 18 during a drain phase. The drain switch 46 is opened during phases other than draining. A wash switch 48 is connected in series with the motor switch 44 and in parallel with the drain switch 46. The wash switch 48 is normally closed and operates the pump motor 18 during washing and rinsing operations. Unless stated otherwise, it is assumed that the wash cycle switch 38, second bus switch 42, and wash switch 48 are closed during operations discussed below. A motor interval switch 50, is connected in parallel with the motor switch 44. The motor interval switch 50 is normally closed, but is held open during all operations except during interrupted operation of the motor 18. The following description relates primarily to the operation of the motor interval switch 50 and corresponding operation of the pump 16 during a washing operation during which flow alternates between the spray arms 20, 22. The combinations and connections of other switches can vary. FIG. 2 shows the status of the other switches during such a washing operation. Referring to FIG. 3, the controller 30 includes a cam wheel 52 driven by a timer motor 54. The cam wheel defines a plurality of coaxial cam disks 55. Plural spring arms 56 are located above the cam wheel 52 and electrically connected to connection lugs 58. The lugs are adapted to be connected to electrical circuits of the dishwasher 10. Referring to FIG. 4, the timer motor 54 rotates an eccentric cam 60 on an axis to oscillate a finger 62 having an eccentric opening 63. The finger 62 engages teeth 64 on the cam wheel 52 to drive the cam wheel stepwise about an axis of the cam wheel 52. The finger 62 is biased toward the teeth 64 by a spring 66. The spring arms 56 are arranged in sets of three, each set including a top arm 56t, a center arm 56c, and a bottom arm 56b. The center arm 56c is provided with a pair of electrical contacts 68 adapted to create an electrically conducting path with a contact 70 on the top arm 56t or a contact 72 on the bottom arm 56b. The bottom arm 56b is biased to normally close its contact 72 with the bottom contact 68 of the center arm 56c. In a conventional manner, contacts 68, 70, 72 on different sets of spring arms 56 are used as the switches 40, 42, 44, 46, 48 discussed above. Preferably contacts 68, 72 on the bottom arm 56b and center arm 56c nearest the front of the controller 30 are used as the motor interval switch 50, for reasons discussed below. A contact spacer 74 positions the top and bottom arms 56t, 56b to maintain a proper air gap between the contacts 68, 70, 72. A cam follower 76 is provided at an end of the center arm 56c. The cam disk 55 nearest the front of the controller 30 corresponds with the spring arms 56 nearest the front. The cam disk 55 engages the cam follower 76 to maintain the center arm 56c in a neutral position wherein the contacts 68, 70, 72 are open, as shown in FIG. 4. A tooth (not shown) on the cam disk 55 will raise the center arm 56c to close the center contact 68 with the top contact 70. This is not utilized in the embodiment shown for the spring arms 56 nearest the front. A gap 78 in the cam disk 55 permits the center arm 56c to lower and close with the bottom contact 72, thereby closing the wash interval switch 50. The front cam disk 55 is arranged with plural gaps 78. The gaps 78 are separated by lobes 80 that raise the center arm 56c and open the wash interval switch 50 to deenergize the pump motor 18. As the cam wheel 52 rotates, gaps 78 and lobes 80 on the cam disk 55 open and close the contacts 68, 72 to control operation of the pump motor 18 and pump 16. Similarly, other dishwasher functions are controlled by other contacts operated by gaps, lobes, and teeth of other cam disks. Referring to FIG. 6, a first timing diagram shows the spacing of gaps 78 and lobes 80 and the corresponding operation of the pump 16. According to a preferred construction of the invention, the lobes 80 are spaced at approximately 180 second intervals and open the wash interval switch 50 (FIG. 2) for 7±3 seconds. Referring to FIG. 5, the timer motor 54 drives an auxiliary cam wheel 82 that is preferably concentric with the eccentric cam 60. The auxiliary cam wheel 82 has a generally smooth surface with a single lobe 84. The auxiliary cam wheel 82 is sized to rotate once in approximately 180 seconds, corresponding with the period of the gaps 78 on the cam disk 55. A lever 86 mounted on a pivot 88 has a cam follower 90 that engages the auxiliary cam wheel 82. An end 92 of the lever 86 opposite the cam follower 90 is positioned to operate an appendage 94 extending from the cam follower 76 of the center arm 56c. When the tooth 84 operates the lever 86, the center arm 56c is lifted to open the switch 50 (FIG. 2). The auxiliary cam wheel 82, thus, overrides the cam disk 55 to deenergize the pump motor 18 regardless of the cam disk 55 position. Referring again to FIG. 6, the lobe 84 opens the switch for 1±0.5 second about every 180 seconds. The lobe 84 is positioned to open the wash interval switch 50 about midway between the lobes 80 on the cam disk 55. Therefore, as shown in the bottom timing diagram, during a 180 second cycle of pump 16 operation, the pump will stop twice, once for 1 second and once for 7 seconds. The stopping of the pump 16 permits the ball 28 of the valve 26 to change positions. When the pump starts again, liquid flows to the opposite spray arm, thereby alternating the flow of wash liquid to the spray arms 20, 22. According to another embodiment of the invention (not shown), the auxiliary cam wheel can operate another switch separate from the motor interval switch 50. The other switch would be connected in series with the motor interval switch 50. Thus, the motor interval switch would not need to be nearest the front of the controller. According to operation of a preferred embodiment, the wash switch 44 is closed during rinsing and draining operations to operate the pump 16 continuously. During washing operations, the wash switch 44 is open and the wash interval switch 50 is operated as discussed above. At the beginning of a wash operation, the cam disk 55 closes the switch 50 to energize the pump motor 18 and pump 16. Liquid flows through the valve 26 to the lower spray arm 22. Flow to the upper spray arm 20 is blocked by the ball 28. After about 60 seconds, the auxiliary cam 82 opens the wash interval switch 50 to deenergize the pump motor 18 and pump 16 for about 1 second. The ball 28 changes positions, the switch 50 closes again, and liquid flows to the upper spray arm 20. Operation continues for about 60 seconds until the cam disk 55 opens the motor interval switch 50 for 7 seconds. Water flows out of the conduit 24 and the ball 28 again switches positions. The motor interval switch 50 closes and water flow to the lower spray arm 22 resumes. Operation continues with alternating flow to the spray arms 20, 22 until the wash operation is completed. At the end of the wash operation, the cam disk 55 opens the motor interval switch 50 for the remainder of the dishwasher operation. Subsequent operation of the pump is controlled by the motor switch 44, drain switch 46 and wash switch 48. The present disclosure describes several embodiments of the invention, however, the invention is not limited to these embodiments. Other variations are contemplated to be within the spirit and scope of the invention and appended claims.

1a

RELATED APPLICATIONS This application is a continuation-in-part application of U.S. Ser. No. 09/824,497 filed on Apr. 2, 2001 now abandoned in the name of Phillip John Campbell and entitled “Flexible Fish Landing Net” and claims the benefit of United States Provisional Application No. 60/301,103 filed on Jun. 26, 2001 in the name of Phillip John Campbell and entitled “Flexible Fishing Net Hoop”. FIELD OF THE INVENTION The present invention relates to net nets for landing fish, and, in particular, to a flexible fish landing net for use from elevated fishing stations. BACKGROUND OF THE INVENTION Sport fishing is oftentimes conducted from elevated locations such as fishing piers and bridges. Various species of varying sizes are commonly caught at such locations. Smaller fish present few problems in landing with the size of the fish being within the strength limitations of the fishing tackle, thereby enabling landing by conventional reeling. Larger fish, however, can present considerable problems. Where a larger fish is hooked, there is a risk that the line will break, due to the weight and movement of the fish prior to successful landing. Under such circumstances, landing may be attempted by traversing the pier until a water location is reached, at which time the fish can be beached, a difficult, cumbersome and time consuming task. At heavily trafficked sites, rental shops may be available whereat the fisherman may be able to rent a suitable large mouth rigid landing net. Inasmuch as such landing nets are large, bulky and costly, few fishermen normally have this type of equipment. Typical of such a net is disclosed in Great Britain Patent No. GB 1,181,354 to Goddard wherein a solid metal ring supports a landing net and is raised as a rigid ring by lifting cords. The net is neither flexible or collapsible. A further version is disclosed in U.S. Pat. No. 3,314,187 to Marcinkowski wherein the netting is collapsible to position a crab trap, however, the support hoop is a rigid circular ring. A limitedly flexible crab net is disclosed in U.S. Pat. No. 2,520,780 to Pieron wherein the periphery of the net is provided by two semi-circular hoops that are diametrically constrained, such that upon lifting the sides are compressed inwardly narrowing the net perimeter. Conventional landing nets are not adapted for such locations. The typical landing net has a fixed hoop with a small attached handle. No provisions are made for lowering these nets from elevated stations. Thus, nets of the type disclosed in U.S. Pat. No. 2,814,899 to Brosius, U.S. Pat. No. 4,021,956 to Hogg, U.S. Pat. No. 4,169,331 to Baker, and U.S. Pat. No. 4,774,783 to Willard have little utility in pier and bridge elevated fishing. In view of the foregoing, it would be desirable to provide a fish landing net for pier, bridge and like elevated fishing that could readily be used by fishermen for safely and conveniently ensnaring heavy fish. SUMMARY OF THE INVENTION The present invention provides a fish landing net that may be collapsed for convenient storage and transportation, and expanded at the site to a full-size landing net that may be lowered from elevated location into the water for netting large and heavy fish that might otherwise escape due to tackle breakage or be released because of difficulties in successfully landing the fish. The landing net includes a flexible, prestressed circular hoop to which heavy duty netting is attached. The hoop is attached to a lifting line by three circumferentially spaced support ropes. The hoop sections around the support ropes have an annealed inner surface, which locally reduces the compressive strength and facilitates reverse bending under loading. When a larger fish is hooked and brought to an underneath location, the net is lowered into the water and maneuvered to ensnare the fish. As the net is raised, the loading forces overcome the prestressing and the reduced compressive strength at lifting locations thereby inwardly deflecting these section and constricting the hoop size and preventing the fish from escaping during landing as well as increasing the stability of the net during vertical movement. When the fish is landed and the load removed, the hoop returns to the original shape for reuse. For storage or transportation, the net hoop may be diametrically twisted into a “Figure- 8 ” shape thereby causing the hoop to fold into a plurality of concentric hoop sections, much is the same manner as band saw blades. The compacted hoop may be conveniently transported along normal fishing gear to be deployed when needed. Accordingly, it is an object of the present invention to provide a fish landing net for heavy fish that is convenient to transport and easy to deploy. Another object of the invention is to provide a fish landing net that provides a large opening for ensnaring a large fish and a constricted opening for retaining the fish during vertical movement to a landing site. A further object of the invention is to provide a fish landing net that is expandable on site to functional sizes and collapsible for convenient storage and transportation. DESCRIPTION OF THE DRAWINGS The above and other objects and advantages of the present invention will become apparent upon reading the following detailed description taken in conjunction with the accompanying drawings in which: FIG. 1 is a perspective view of a flexible fish landing net according to an embodiment of the invention, in the open position; FIG. 2 is a perspective view of the fish landing net of FIG. 1, in the closed position; FIG. 3 is a side elevation view of the retaining hoop in the unformed position; FIG. 4 is a perspective view of the retaining hoop in the open position; FIG. 5 is side schematic view of the landing net in the open position, with the net attached, showing the suspension of the retaining hoop; FIG. 6 is an enlarged fragmentary view of the retaining hoop showing the lifting rope mounting holes; FIG. 7 is a view similar to FIG. 6 showing the lifting rope on the retaining hoop in the open position; FIG. 8 is a view similar to FIG. 8 showing lifting rope bending the retaining hoop section toward the closed position; and FIGS. 9 through 11 are side elevation views showing the collapsing the retaining hoop from the open position to the collapsed position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawings for the purpose of describing the preferred embodiment and not for limiting same, FIG. 1 illustrates a flexible fish landing net 10 for landing fish from a elevated fishing station, such as a pier or bridge wherein the weight and size of the fish is potentially greater than the strength of the fishing tackle. As such, the net is distinguished from regular fishing nets used by sports fisherman and typically ranges in size from two to three feet or larger. The landing net 10 comprises a flexible retaining hoop 12 having a generally circular configuration in the illustrated open position, a netting 14 having top loops 16 periodically peripherally threaded over the retaining hoop 12 and depending therebelow, and a lifting rigging 18 attached at three circumferentially spaced locations to the hoop 12 and operable for lowering and raising the net 10 from the fishing station. During the raising of the net 10 , with a larger fish carried in the netting, the load and the lifting rigging 18 are operative to cause the retaining hoop 12 to flex inwardly at three reversely bent lobes 19 to a closed position of restricted opening during raising movement, as shown in FIG. 2, to securely retain the fish within the netting 14 and stabilizing the lifting load. Referring to FIGS. 9 through 11, for storage and transportation, the retaining hoop 12 in the open position of FIG. 9 may be diametrically twisted into a “Figure- 8 ” position, as shown in FIG. 10, and inwardly collapsed to form a series of concentric subhoops 20 as shown in FIG. 11, thereby establishing a compact storage position. More particularly, the retaining hoop 12 is formed of an elastic material and establishes a prestressed circular condition in the open position sufficient for maintaining the continuous open profile while being insufficiently stressed or strong to resist locally inward deflection of the nodes 19 toward the closed positions shown in FIGS. 2 in the presence of a sufficiently large fish. As described in greater detail below, the retaining hoop is annealed at the inner surface by reverse bending at the attachment locations to reduce the inward loading required for establishing the nodes 19 and facilitate the inward deflection. Referring to FIG. 3, the retaining hoop 12 may be formed from an elongated single strip 30 of planar material. The strip 30 has a rectangular cross section of moderate to high aspect ratio for preventing vertical flexing about the transverse section axis while permitting the aforementioned inward deflection about the longitudinal section axis in the presence of threshold loading. An aspect ratio of height to thickness of at least 2:1 is satisfactory, an aspect ration in the range of 3:1 to 6:1 desirable, and an aspect ratio of about 4:1 preferred. A preferred material is plastic such a nylon. The strip 30 is provided with a plurality of through holes for use in assembly and rigging. A pair of fastener holes 32 are formed at each end of the strip 30 . For assembly the ends are overlapped and suitable fasteners 34 , such as nuts and bolts, are inserted through the fastener holes and tightened to fixedly establish a circular shape for the retaining hoop by flexing the strip and establishing a stressed outer skin condition therein. Three evenly circumferentially and closely spaced sets of rigging holes 40 are formed along the length of the strip 30 . The rigging holes 40 in the assembled hoop are equally circumferentially spaced 120° apart. Consistent with the above, a retaining hoop formed of nylon with a ¾ by {fraction (3/16)} inch cross section, is effective for a 30 inch diameter hoop. The netting 14 may be formed of any suitable, commercially available material and is configured to provide a closed lower end and an open upper end 52 terminating with the end loops 16 . The end loops 16 are threaded onto the strip 30 prior to assembly and thereafter uniformly circumferentially spaced thereabout. The length of the netting is sufficient to provide ample volume for retaining targeted species and sizes of fish. The rigging 16 comprises a three-point rigging at a lower section 70 and an upper section 72 interconnected by a middle coupling section 74 . Referring to FIGS. 6 through 8, the lower section 70 includes three arms 76 . Each arm 76 terminates with outwardly diverging end 77 establishing circumferentially spaced loadings at the attachment locations. The arm is sequentially threaded inwardly under the hoop along a first run, through one of the holes 40 , along the inner periphery of the hoop, and outwardly through the other hole. The free end is then knotted to establish the lengths of the ends. In the preferred embodiment, the ropes are a tubular braided polyethylene. The distal end is heat terminated and inserted into the tubular core to fix the attachment. The upper ends of the rope arms 76 are gathered and knotted to form a lifting loop at the coupling section 74 . The lower end of the upper section 72 , preferably a single strand of roping, is attached at the lifting loop with a non-slipping marine knot. Under loading conditions, it bas been found as shown in FIG. 5 that an inclination of the arms at about 45° to 60° with respect to vertical provides preferable results. Under sufficient loading at the net, the inwardly directed loading forces at the lower section of the rigging will overcome the prestressing and inwardly reversely flex the hoop at the nodes 19 at the attachment locations. The nodes 19 converging toward the center of the deformed hoop, causing the hoop to assume a progressively closed position under loading conditions that exceed the threshold prestressed value. Thus smaller fish raised by the landing net may be insufficient to close the net, but may nonetheless be securely upwardly raised under stable, balanced conditions. Larger fish, more prone to activity, will be prevented from escape, by the flexing closure of the hoop. The flexing characteristics of the hoop are enhanced by locally annealing the hoop sections adjacent the attachment sections surrounding the holes sufficient to lower the compressive strength thereat and accommodate the reverse deflection. For the preferred nylon hoop material, the hoop sections may be annealed by reverse flexure as shown by the arrows in FIG. 8 . Such annealing has been determined to significantly reduce the net closing forces required to effect the collapse of the hoop as shown in FIG. 2 . The nodal tendencies are also increased by the circumferentially spaced points, and by the ends 77 engaging the lower surface of the hoop and exerting further inward and upward force vectors for overcoming the residual annealed compressive strength at the inner surface and promoting the nodal buckling. The annealing of the strip may be performed either before hoop formation of after assembly, by manual or mechanical bending. A limited number of moderate bends are generally sufficient. In use, when the user has hooked a fish and desires to utilize the landing net 10 for securing and landing a fish from the elevated fishing station, the collapsed landing net is removed from the carrying container and the subhoops reversely rotated allowing the prestressing to expand the hoop 12 to the open position. The expanded net is lowered into the water and maneuvered below the fish. The rigging 18 is manually raised to capture the fish within the netting 14 in the confines of the hoop. As the net is raised above water level, the increasing loading on the rope arms 76 , in the presence of a sufficiently large fish, will inwardly deflect the hoop 12 at the node 19 narrowing the top opening and thereby securing the fish therewithin. When the fish is landed at the elevated station, the loading is released allowing the hoop to assume the open position and faciliatating safe removal of the landed fish. Having thus described a presently preferred embodiment of the present invention, it will now be appreciated that the objects of the invention have been fully achieved, and it will be understood by those skilled in the art that many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the sprit and scope of the present invention. The disclosures and description herein are intended to be illustrative and are not in any sense limiting of the invention, which is defined solely in accordance with the following claims.

1a

BACKGROUND OF THE INVENTION Author of the invention while at occupational therapy has noticed that human fingers are the most efficient tools in performing massaging therapy on damaged tissues around the scars. Among many available massaging devices one with the humanlike fingers is missing. Work on the project produced massaging device prototype with two unbendable fingers. Their massaging action was not as good though as an action of the straight thumb and bendable index finger or middle finger. Successful design of bendable finger has revealed a great opportunity for using it in the future development of the prosthetic hands. Upon review of the previous US patents in the field of mechanical fingers, hands and grasping devices and comparing their fingers and palm designs to the one presented here it becomes apparent that presented here solutions can make a real progress in creating practical and affordable prosthetic hand. Most of the previous designs are complicated, expensive and they give very little if any consideration to the esthetic side of the prosthesis. Those designs are more suitable for the robotic rather than for the human applications with exception of the few argued below. U.S. Pat. No. 4,685,929 J. Monestier. This invention provides soft gripping hand with the fingers of attractive humanlike appearance. However a fingers comprising of such a high number of elements would be very difficult or impossible to manufacture in humanlike dimensions. The other disadvantage would be their high cost. Another U.S. Pat. No. 7,655,051, M. Stark provides prosthetic hand with fingers biased in a closed position by springs and digits are opened by a cord attached to the dorsal side of the top digit. In this design gripping force of digits depends on the strength of a springs and it is believed that fingers would lose their humanlike size with the larger springs guaranteed a decent grip. Also it is hard to predict which phalange will start moving first upon release of the cord what would cause grips to be rather uncontrollable. The most appealing solutions for making a simple and inexpensive prosthetic hand are those by Frank L. Dale, U.S. Pat. No. 2,457,305. Dale teaches that it is possible to create prosthetic finger using just one element as a driving rod to bend finger and as a spring to straighten a finger. In my invention finger bending and straightening motion needs four elements a driving rod two tendons and a spring and although Dale's design is more simple it carries some crucial limitations compare to the design presented here; a) a digits of Dale's fingers need more space in front to place there a channel for a rod/spring element and fingers humanlike appearance may be compromised b) finger's bending motion will always start from the top digit contrary to the human fingers where all three digits are moving at the same time and while making most common grasping motion the Dale's fingers will have a tendency to slide off an objects attempted to be grasped from the top c) not having any adjustable elements to the finger's digits is a greatest limitation to Dale's finger comparing to my design where the middle digit's motion is regulated by the length of a first tendon or by an adjustable rod what allows to create a variety of prosthetic hands with different grips complementing individual needs as well as allowing to use finger in other applications like that in presented here massaging device where Dale's fingers would work improperly by pinching top portion of the flesh with a top digits instead of engaging larger portion of a fingers with a wider and deeper portion of the human body. Prosthetic hand with presented here fingers will not only look like the real one but will be able to perform a few simple tasks in it basic form as well as multiple tasks in it most developed and computerized form. References Cited U.S. Patent Documents 3,694,021 September 1972 Mullen 3,866,966 February 1975 Skinner, II 3,927,424 December 1975 Itoh 4,377,305 March 1983 Horvath 4,834,443 May 1989 Crowder et al. 4,980,626 December 1990 Hess et al. 4,984,951 January 1991 Jameson 4,986,723 January 1991 Maeda 5,080,681 January 1992 Erb 5,108,140 April 1992 Bartholet 5,200,679 April 1993 Graham 5,280,981 January 1994 Schulz 5,378,033 January 1995 Guo et al. 5,762,390 June 1998 Gosselin et al. SUMMARY OF THE INVENTION Presented here finger is operated by the rods, tendons and springs. Compacted design of the finger allows having it in the natural size and be covered by a flesh imitator. Applications are versatile and allow creating variations of the prosthetic hands in order to satisfy individual needs of amputees. The most basic and most affordable design of the prosthetic hand would be the one with the second phalanges adjustable rods being anchored in the arm and inactive after choosing desirable tension to the first tendon and giving the biggest slack to the thumb or adjustable rods being abandon altogether and the first tendons anchored to the back of the palm below the first phalange after deciding on the proper length of the tendons. All of the first phalanges activating rods would be connected to the one common element which would be activated one way only by the pneumatic pressure preferably and being pushed back by the spring upon the release. This hand would perform a basic grasping grip and assist amputees in the simple tasks like holding a steering wheel, a joystick, a hand bag, a glass, a railing and as such. The hand opening and closing button would be operated by the toe as an example. The last and the most developed form of the prosthetic hand would be the one with most of the rods connected to the separate actuators operated by servomotors or solenoids. The computer chip would allow activating a combination of different rods and performing different grips on the voice command . . . For example command “SPOON” would first activate driving rods of pinky, ring, and the middle finger to close them partially and activate afterwards driving rod of the index finger and the thumb as well as the thumb adjusting rod to give more slack to its first tendon. The commands “PEN” or “PINCH” would perform the same or very similar grip. On the command “PIANO” all fingers would bend except for the index finger which would be kept straight to perform typing like tasks. In the middle between basic and the most developed forms of prosthetic hands there would be some special order designs with only few actuators to perform selected tasks or some custom made like for example one with the first phalanges pivoting ears being positioned on the palm with slightly bigger angles between them so the fingers in the open position will be spread more apart to perform task of grasping larger, grapefruit like objects. All variations of prosthetic hands will use the same unchangeable elements. Similar elements can be also used for the wrist design. Just two more ears added at the base of the arm, two more clevises in the palm, connecting pins and the driving rod. Presented here massaging device can be easily mounted not only in the back of the chair as shown on the drawing but also can be accommodated into other structures like benches, mats and as a such with the purpose to use it in the spas, gyms, physiotherapy clinics as a multiple massaging units. It can be also used as a single unit being hold in one hand and providing massage to the different parts of the body and most likely being used as a masseur's helper. The other possible applications will be explained in the description of the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is the front view of the finger without a flesh imitator. FIG. 2 is the main section of the finger. FIG. 3 is the side view of the phalange 1 and the phalange 2 . FIG. 4 is the back view on the adjustable rod and the lower end of the first tendon. FIG. 5 is the section through the guiding pin. FIG. 6 is the cross section of the third phalange. FIG. 7 is the main section of the massaging device. FIG. 8 is the view of the finger's skeleton in straight and in bent positions. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 It shows first phalange 1 , second phalange 2 , third phalange 3 , first tendon 4 , second tendon 5 , activating rod 6 and rod's guiding pin 9 . Each phalange has a clevis at one end and one ear at the other end. Guiding pin 9 is placed with loose in the round holes made across the ears placed on the palm structure and has a role to allow side movements of the upper part of the rod while restricting undesirable side movements of the lower part of the rod. The driving rod protrudes with the loose through the hole made across said pin 9 . This will allow for the unrestricted up and down movement of the driving rod. On the palm structure are shown two more single ears for mounting the neighboring fingers. FIG. 2 It shows all elements and describes the mechanics of the presented invention. It shows driving rod 6 placed in the clevis of the first phalange 1 and connected to that phalange by the pin 12 which is press fitted in the clevis and loose in the rod. In the middle of the first phalange 1 there is an opening through which protrudes firs tendon 4 . Said tendon 4 can be anchored to the back of the palm structure or, as shown here, can be connected to the adjustable rod 7 . The other end of the tendon 4 is firmly connected to the front of the second phalange 2 by an any means of the firm connection, and depending on the materials used, it can be glued, thermo integrated with the second phalange's material, connected by a mechanical fasteners and as such. The same connection applies to the both ends of the second tendon 5 which is permanently anchored to the back of the first phalange, protrudes through the middle opening of the second phalange and is firmly connected to the front of the third phalange 3 . The similar fastening will also apply to the lower end of the flat spring 8 which is permanently connected to the back of the first phalange. The upper end of said spring 8 protrudes through the slot placed at the back of the third phalange. The role of the spring is to straighten second and third phalanges upon up movement of the rod 6 . The spring can be single flat or multiple flats depending on the version of the prosthetic hand and the flexibility of the flesh imitating material. Pins 10 connect firs phalange to the palm structure and the second phalange to the first phalange. The smaller pin 11 connects phalange 3 with phalange 2 . The pins are press fitted in the devises and having a loose in the ears. Upon the movement of the first phalange initiated by the down moving rod 6 the first tendon 4 will be stretched because it's lower end is not attached to the pivot point of the phalange 1 but to an element behind. This tension of the tendon will initiate movement of the second phalange. Similarly the movement of the third phalange will be initiated by the stretch of the second tendon upon movement of the second phalange. The length of the tendons as well as a shape of the lower back of the first and the second phalanges will determine amount of the stretch of the tendons and therefore will determine degree of the movement of the phalanges. The tension of the first tendon can be also adjusted by the down or up movement of the rod 7 and will apply mostly to the thumb finger because thumb for most of the grips, has a different timing for closing than remaining four fingers. It is believed that for all fingers the third phalanges degree of movement don't need any adjustments as they are moving in the strict relation with the second phalanges except for the thumb again. But in order to accommodate for the fundamental movements steering elements for all the fingers in the arm limited space, some secondary functions are intended to be abolished as the goal of this invention is not to create perfect human prosthetic hand but rather more simple, yet practical, reliable and affordable one. FIG. 3 It shows first and second phalanges clevises and ears configuration at the pivot point. They are shaped to make a contact in the point P and keep phalanges in the straight position when open and prevent them from over bending by the action of the spring 8 . FIG. 4 It shows adjustable rod 7 and the lower end of tendon 4 . It shows the one of many possible connections between them throughout pin 11 which is press fitted in the rod's clevis. FIG. 5 It is the section throughout guiding pin 9 and protruding across it activating rod 6 shown and described previously on FIG. 1 . The same mechanism is used also in the massaging device FIG. 7 for connecting fingers 24 and 25 with disc 23 . FIG. 6 It is the cross section of the top of the third phalange 3 . It shows slot at the back of phalange throughout which protrudes spring 8 . FIG. 7 It shows the massaging device installed in the back of the chair. It shows all the parts used and describes mechanics of said massaging device. Cylinder 21 is threaded on its outside bottom diameter and is fastened to chair's structure by nuts 27 . Special washers 28 are having unparallel surfaces on both sides what allows to adjust device's mounting angle on the chair. Inside cylinder 21 is placed piston 22 sealed with O rings 14 . The bottom boss of the piston 22 is out of round to accommodate for the gripping tool during assembly. Under the bottom of the piston is placed spring 26 and washers 20 and 30 . Inner wall of the lower end of the cylinder 21 has thread to connect closing plug 29 . Connection is sealed by gasket 17 . In upper part of the cylinder there is threaded side hole in which is placed nozzle 19 . Hose 16 is attached to the nozzle and secured by clip 18 . Upper part of the cylinder 21 has a bigger diameter to accommodate for the fingers 24 and 25 as well as the driving disc 23 . Said driving disc 23 is round and is guided with loose in the round opening made in the upper end of cylinder 21 . Disc 23 has two slots opposite to each other and two round holes across the slots. In said across holes are placed with loose guiding pins 13 which have round holes across them. Disc 23 has a threaded hole in the centre and is connected through it with the rod of the piston 22 . Cylinder 21 has a hole in the centre between the lower and the upper part of the body. Through this hole protrudes piston's 22 rod and it is sealed with the O ring 15 . Two slots opposite to each other are made in the wall of the upper body of the cylinder 21 . In those slots are placed fingers 24 and 25 which are connected to the body of said cylinder 21 with the pins press fitted in the across holes. This connection is the same one than between the finger and the palm structure and was earlier described on FIG. 1 and FIG. 2 . Also the finger 24 is the same than earlier described on FIG. 1 , FIG. 2 , FIG. 3 and FIG. 6 . The only difference is that the clevis to connect activating rod at the front of the lower end of first phalange is eliminated and this part of the phalange is shaped into the round pin. Those round pins placed at the bottom of the fingers 24 and 25 are protruding with loose through across holes of the guiding pins 13 . Said guiding pins 13 are acting the same way than earlier described on FIG. 1 and FIG. 5 guiding pin 9 . They will turn in their round holes of the disc 23 during up and down movement of said disc what will allow for sliding in them round bottom pins of the fingers 24 and 25 and therefore allow unrestricted movement of the fingers. Described above two fingers are intended to imitate pinching action of the thumb and the index or the thumb and the middle finger. One or two more slots can be added though to the upper wall of the cylinder 21 as well as to the driving disc 23 and one or two more fingers or specifically shaped claws can be accommodated into these slots. Such a device can be attached to a tip of mechanical arm or a manipulator. The presented here massaging device is powered preferably by pressurized air what will allow to install multiple units in a chair or other structure and operate them by a single pump. The air supplied through hose 16 will drive piston 22 down and together with it will drive down disc 23 . Down movement of the disc 23 will create closing action of the finger 24 and finger 25 together with the bending action of the finger 24 as per previous description. The opening of the fingers is done by the action of compressed spring 26 upon release of the air pressure. FIG. 8 It shows skeleton of the finger and both tendons in the straightened inactive position as well as a bare skeleton of the finger in the closing position. This figure is intended to clarify the fingers bending mechanism. The entire finger without tendons from the first upward position to the second lower position would rotate about point A. Point C of the second phalange where upper end of the first tendon attaches would move along the arc defined by radius R and in lower position would take location C 2 . Point C of the upper end of the first tendon will rotate about point B along the arc defined by radius R 1 and in the lower position will take location C 1 forcing therefore point C 2 to move along the arc defined by radius r to the location C 1 where the arcs of radius R 1 and radius r intersect. The same principle applies toward rotation of the third phalange upon stretching of the second tendon and it is very characteristic to this design that top phalange will be bending spontaneously with the middle phalange just like in our human fingers where it is very difficult or impossible to bend middle digit without bending top digit at the same time.

1a

FIELD OF THE INVENTION The present invention generally relates to a compression device for applying compression therapy to a body part of a wearer. BACKGROUND OF THE INVENTION Generally, intermittent pneumatic compression (IPC) systems for deep vein thrombosis (DVT) prophylaxis consist of a controller having a pump and associated control electronics, a compression sleeve (e.g., a sequential compression sleeve) which is applied to the patient's body part, and tubing sets that communicate between the pump and the sleeve. Sequential compression sleeves are typically constructed of two sheets of fluid impermeable material joined at seams to define one or more fluid impervious bladders. The tubing connects the bladders to the pump for inflating the bladders to apply compressive pressure around the patient's body parts. Typically, the controller is programmed to perform cyclic compression by pumping air into the bladders of the sleeve during a compression segment of the cycle followed by exhausting air from the bladders during a deflation segment of the cycle. The air exhausts through one or more exhaust ports associated with the controller (see Prior Art FIGS. 1 and 2). The exhaust ports usually vent to atmosphere around the patient, deflating the sleeve to enable blood to reenter the veins. The bladders may be covered with a laminate to improve durability and protect against puncture. The impermeability of the sleeve can trap moisture (i.e., perspiration) between the bladder sheets and the patient's body, causing some discomfort. Discomfort can lead to the patient's unwillingness to wear the sleeve, potentially endangering the patient's health. An advancement in this field has been to place the controller directly on the sleeve, eliminating the need for long and unwieldy tubing sets. These systems, though portable, do not address the issues of moisture build-up that can occur with conventional compression sleeves. The present invention provides an improved arrangement for reducing moisture build-up and improving patient compliance. SUMMARY OF THE INVENTION In one aspect, the present invention includes a compression device for providing compression treatment to a limb of a wearer. The device comprises a compression garment positionable on the limb of the wearer. The garment comprises an inflatable bladder for providing compression treatment to a compression region of the limb. The device also includes a controller fluidly connected to the inflatable bladder and configured for inflating and deflating the bladder during a compression cycle. The controller includes an exhaust port positioned to direct exhaust fluid toward the compression region as the bladder deflates so exhaust fluid flows over the limb of the wearer to cool the limb. In another aspect, the invention includes a method of providing compression treatment to a limb of a wearer using a compression device including an inflatable bladder positioned on the limb of the wearer and a controller fluidly connected to the inflatable bladder. The method comprises pressurizing the inflatable bladder with pressurized fluid from the controller to inflate the bladder and compress a compression region of the limb. Further, the inflatable bladder is depressurized by venting the pressurized fluid out of the inflatable bladder. The method includes exhausting the vented fluid out of the controller through an exhaust port in the controller and directing the vented fluid toward the compression region of the limb to cool the limb. In still another aspect, the present invention includes a compression device for providing compression treatment to a limb of a wearer. The device comprises a compression garment positionable on the limb of the wearer. The garment comprises an inflatable bladder for providing compression treatment to a compression region of the limb. The garment has an opening and a controller fluidly connected to the inflatable bladder and configured for inflating and deflating the bladder during a compression cycle. The controller includes an exhaust port positioned to direct exhaust fluid through the opening in the garment and to direct the exhaust fluid toward the compression region as the bladder deflates so exhaust fluid flows over the limb of the wearer to cool the limb. The device also includes a guide attached to the bladder around the opening for guiding fluid directed to the opening to flow over the limb of the wearer. Other objects and features will be in part apparent and in part pointed out hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic of a first configuration of a prior art compression device; FIG. 2 is a schematic of a second configuration of a prior art compression device; FIG. 3 is a perspective of a compression device of the present invention secured to a leg of a wearer with portions of the device partially removed to show underlying layers; FIG. 4 is a front elevation of a compression sleeve of the compression device with an outer cover and intermediate layers of the sleeve partially removed to show underlying layers; FIG. 5 is an enlarged fragmentary elevation of the outer cover illustrating loop material; FIG. 6 is a perspective view of a controller of the compression device; FIG. 7 is a rear view of the controller; FIG. 8 is an enlarged fragmentary section showing an exhaust port in the controller in registration with an opening in the sleeve; FIG. 8A is a schematic representation of the compression device of FIGS. 3-7 ; FIG. 9 is a schematic of a second embodiment of a compression device of the present invention; and FIG. 10 is an enlarged fragmentary elevation of an inner surface of a first intermediate layer of the compression sleeve. Corresponding reference characters indicate corresponding parts throughout the drawings. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings and in particular to FIGS. 3 and 4 , a compression device for applying cyclical compression therapy to a limb (e.g., a leg) of a wearer is indicated in its entirety by the reference number 10 . The compression device 10 comprises a compression sleeve 12 and a controller 14 (or “air compressor unit”) directly attached to the compression sleeve for supplying pressurized fluid to the sleeve 12 for providing compression therapy to the limb. The compression device 10 has a portable configuration such that the wearer of the device can more easily move about while wearing the device. However, the controller 14 may have a configuration other than portable such that the controller is not directly attached to the sleeve 12 without departing from the scope of the invention. The compression sleeve 12 is of the type sized and shaped for being disposed around a leg of the wearer, but could be configured to be applied to other parts of the wearer's body. More specifically, the sleeve 12 has a width W ( FIG. 4 ) for being wrapped around a full circumference of the leg and a length L for running from the ankle to a knee of the leg. This type of sleeve is generally referred to in the art as a knee-length sleeve. It will be understood that a compression sleeve may come in different sizes, such as a thigh-length sleeve (not shown) extending from the ankle to the thigh of the leg. It is understood that compression devices having other configurations for being disposed about other parts of the wearer's body, are also within the scope of this invention, such as a wrap around a patient's chest in the treatment of breast cancer. Referring to FIG. 4 , the compression sleeve 12 may comprise four layers secured together. The scope of the present invention, however, is not limited to four layers ( FIG. 3 shows the compression sleeve 12 having only two layers.) In the illustrated embodiment, the compression sleeve 12 comprises an inner layer, generally indicated by 16 , on which a first intermediate layer (broadly, a first bladder layer), generally indicated by 18 , is overlaid. A second intermediate layer (broadly, a second bladder layer), generally indicated by 20 , overlies the first intermediate layer 18 and is secured thereto. An outer cover generally indicated by 22 , overlies and is secured to the second intermediate layer 20 . In use, the inner layer 16 will contact the limb of the wearer, and the outer cover 22 will be farthest from the limb of the wearer. If the sleeve 12 is constructed using only two layers of material (e.g., two bladder layers 18 , 20 ), then the first bladder layer 18 will contact the limb of the wearer, and the second bladder layer 20 will be farther from the limb of the wearer (see FIG. 3 ). The layers have the same shape and are superposed on each other so edges of the layers generally coincide. It is contemplated that one or more of the layers 16 , 18 , 20 , or 22 may not be superposed on a corresponding layer, but slightly offset to accommodate a particular feature of a patient's limb. Moreover, the number of sheets making up the compression sleeve 12 may be other than described. The first and second intermediate layers 18 , 20 , respectively, each include a single sheet of elastic material (broadly, “bladder material”). For example, the sheets 18 and 20 are made of a pliable PVC material having a thickness of about 0.006 inch. The inner and outer layers 16 and 22 can be made of a polyester material having a thickness of about 0.005 inch. The materials and thicknesses of the layers may vary to add strength or to cause more expansion in one direction, such as toward the limb, during inflation. The second intermediate layer 20 may be secured to the first intermediate layer 18 along bladder seam lines 26 defining a proximal bladder 28 a , an intermediate bladder 28 b and a distal bladder 28 c , respectively, that are spaced longitudinally along the length L of the sleeve 12 . The number of bladders may be other than three without departing from the scope of the present invention. As used herein, the terms “proximal”, “distal”, and “intermediate” represent relative locations of components, parts and the like of the compression sleeve when the sleeve is secured to the wearer's limb. As such, a “proximal” component or the like is disposed most adjacent to a point of attachment of the wearer's limb to the wearer's torso, a “distal” component is disposed most distant from the point of attachment, and an “intermediate” component is disposed generally anywhere between the proximal and distal components. The bladders 28 a , 28 b , 28 c are circumferential bladders meaning that they are sized and shaped to wrap around the wearer's limb or around very nearly the entire circumference of the limb. For example, in one embodiment, the bladders 28 a , 28 b , 28 c each extend around at least 90% around a leg. It is to be understood that the construction described herein can be adopted by the prior art sleeves with a partial bladder construction, without departing from the scope of the present invention. The intermediate layers 18 , 20 may be secured together by radiofrequency (RF) welding, adhesive, or other chemical and/or mechanical process. Further, the intermediate layers 18 , 20 may be secured together at other locations, such as around their peripheries or at the bladder seam lines 26 to further define the shape of the inflatable bladders 28 a , 28 b , 28 c . The first intermediate layer 18 may be secured to the inner layer 16 along a seam line 46 extending along the outer periphery of the first intermediate layer 18 so central regions of the bladders 28 a , 28 b , 28 c are not secured to the inner layer 16 permitting the bladders to move relative to the inner layer 16 . The second intermediate layer 20 may also be secured to the inner layer 12 along the same seam line 46 . The first intermediate layer 18 may be secured to the inner layer 16 by RF welding, adhesive, or in other suitable ways. Referring to FIG. 4 , each inflatable bladder 28 a , 28 b , 28 c receives fluid from the controller 14 mounted on the sleeve 12 via a dedicated proximal bladder tube 34 a , intermediate bladder tube 34 b , and distal bladder tube 34 c , respectively, fluidly connecting the bladders to the controller. As will be appreciated, a tube line need not be dedicated to a bladder to practice the invention. In one embodiment, the bladders 28 a , 28 b , 28 c are configured to hold air pressurized in a range of about 10 mm Hg (1333 Pa) to about 45 mm Hg (6000 Pa). Further, the bladders 28 a , 28 b , 28 c are preferably capable of being repeatedly pressurized without failure. Materials suitable for the sheets include, but are not limited to, flexible PVC material that will not stretch substantially. In another embodiment, the intermediate layers 18 , 20 may form a chamber for receiving an inflatable bladder that is formed separate from the chamber. In this embodiment, the layers 18 , 20 need not be capable of containing pressurized air provided the inflatable bladders are. As will be appreciated by those skilled in the art, the bladders 28 a , 28 b , 28 c may have openings 36 extending completely through the bladders. Further, these opening 36 may be formed by a seam line 30 sealing the bladder layers 18 , 20 together. In the illustrated embodiment, the openings 36 are tear-drop-shaped, but the openings may have other shapes without departing from the scope of the invention. The inner layer 16 may be constructed of a material that is capable of wicking moisture. The inner (or “wicking”) layer 16 , through capillary action, absorbs moisture trapped near the limb of the wearer, carries the moisture away from the surface of the limb, and transports the moisture from locations on the limb at the inner layer 16 where the moisture is abundant to areas where it is less abundant (e.g., closer to the openings 36 in the bladders 28 a , 28 b , 28 c ), to evaporate to the ambient environment. The openings 36 may have various sizes, shapes, and locations within the area of the bladder providing the compression. Each opening 36 may expose the wicking layer 16 to the ambient air as opposed to the portion of the wicking layer beneath the bladder material. The portions of the inner layer 16 in registration with the openings 36 may be referred to as “exposed portions”. Other ways of exposing the wicking material such as slits or extending the wicking material outside the perimeter of the bladder material are also envisioned as being within the scope of the present invention. If the sleeve 12 is constructed having only two bladder layers 18 , 20 , then the openings 36 expose portions of the limb of the wearer to the atmosphere. In the illustrated embodiment, the bladders 28 a , 28 b , 28 c have openings 36 . Thus, the regions of the sleeve 12 that expand and contract under the influence of air pressure or other fluids to provide compression have the openings 36 . The regions of the sleeve 12 that do not provide compression (e.g., the seam lines 26 ) do not have openings 36 . The wicking material 16 may be inter-weaved with the impervious material to form the inner layer 16 that transports moisture to an area of less moisture. The openings 36 must be sized, shaped, and positioned so the sleeve provides adequate compression to maintain blood velocity, while maximizing evaporation of moisture. Suitable wicking materials may comprise, for example, some forms of polyester and/or polypropylene. Microfibers may be used. Suitable microfiber materials include, but are not limited to, CoolDry model number CD9604, sold by Quanzhou Fulian Warp Knitting Industrial Co., Ltd. of Quanzhou City, Fujian Province, China, and CoolMax®, sold by E. I. duPont de Nemours and Company of Wilmington, Del. Referring to FIGS. 4 and 5 , the outer cover 22 of the compression sleeve 12 may be constructed of a single sheet of material. In the embodiment, the outer cover 22 is breathable and has a multiplicity of openings 40 or perforations so it has a mesh construction to provide even more breathability. A suitable material for the outer cover 22 may be a polyester mesh. The rate of evaporation through the openings is improved by treating the fibers of the mesh material with a hydrophilic material, so the mesh material absorbs the wicked fluid more readily. Wicking fibers of this type are indicated generally by 42 in FIG. 5 . These hydrophilic fibers 42 lower the surface tension of the mesh material to allow bodily fluids to more easily absorb into the fibers and spread through the material to provide more efficient evaporation of the wicked fluid. Absorbing fluid more readily allows the fluid to move to the open areas more quickly for evaporation. The capillary effect is made more efficient when the absorbed fluid from the openings moves more quickly through the mesh outer cover 22 . The entire outer surface of the outer cover 22 may act as a fastening component of a fastening system for securing the sleeve 12 to the limb of the wearer. In a particular embodiment, the outer cover 22 of mesh ( FIG. 5 ) has an outer surface comprising loops 48 , that act as a loop component of a hook-and-loop fastening system. A mesh construction, as shown in FIG. 5 , may have interconnected or weaved fibers 42 of material forming the outer cover 22 . The loops 48 may be formed as part of the material of the outer cover 22 or otherwise disposed on the surface of the outer cover. A suitable material with such construction is a polyester mesh loop 2103 sold by Quanzhou Fulian Warp Knitting Industrial Co., Ltd. of Quanzhou City, China. Hook components (not shown) may be attached to an inner surface of the inner layer 16 at proximal, intermediate and distal flaps 50 a , 50 b , 50 c , respectively ( FIG. 4 ). The loops 48 of the outer cover 22 allow the hook components to be secured anywhere along the outer surface of the outer cover 22 when the sleeve 12 is wrapped circumferentially around the limb of the wearer. This allows the sleeve 12 to be of a substantially one-size-fits-all configuration with respect to the circumferences of different wearers' limbs. Moreover, the loops 48 on the outer cover 22 allow the practitioner to quickly and confidently secure the sleeve 12 to the wearer's limb without needing to align the fastening components. It is contemplated that the outer cover 22 may be capable of wicking fluid in addition to being breathable. For example, the outer cover 22 may be constructed of the same material as the inner layer 16 (e.g., Cool dry). In this way, the moisture wicked by the inner layer 16 may be wicked by the outer cover 22 through the openings 36 in the bladders 28 a , 28 b , 28 c . The moisture can spread out evenly across the outer cover 22 and is able to evaporate more readily than if the outer cover was not formed of a wicking material because a greater surface area of the outer cover, as opposed to the inner layer 16 , is exposed to air. Alternatively, the cover 22 can have a wicking material laced in or on top of outer layer. Referring to FIGS. 6-9 , the controller 14 comprises a housing 60 enclosing the necessary components for pressurizing the bladders 28 a , 28 b , 28 c . The controller 14 may be programmed to execute various compression regimens, which may include inflation and deflation (vent) phases. A configuration in which a controller 14 is removably mounted on a compression garment and operatively connected to bladders on the compression garment is disclosed in more detail in U.S. patent applications Ser. Nos. 12/241,670, 12/241,936, and 12/893,679 which are assigned to Tyco Healthcare Group LP and incorporated by reference in their entireties. Other embodiments where the controller 14 is not configured for mounting directly on the sleeve 12 are also within the scope of the present invention. Supply ports 62 in the controller housing 60 are configured to attach the bladder tubes 34 a - c to the controller 14 for delivering pressurized fluid to the inflatable bladders 28 a - c . An exhaust port 64 ( FIG. 7 ) is disposed in a back 66 of the controller housing 60 for expelling the vented pressurized fluid from the compression device 10 during the vent phase. In the illustrated embodiment, a single exhaust port 64 is shown. However, the controller 14 may also have a plurality of exhaust ports without departing from the scope of the invention. Referring to FIGS. 3 and 8 , the controller 14 is mounted on the sleeve 12 such that the exhaust port 64 faces an outer surface of the sleeve (e.g., outer cover 22 or second intermediate layer 20 ). Therefore, during the vent phase, the exhausted fluid is not expelled into ambient as is the case with prior art designs. Instead, the vented fluid is directed onto the sleeve 12 . The vented air will flow past the outer cover, bladder layers and inner layer, and flow over the leg of the wearer providing a cooling effect to the leg and improving moisture evaporation, because the outer cover 22 is formed of a mesh material, because the bladder layers 18 , 20 have openings 36 , and because the inner layer 16 is gas permeable. In the illustrated embodiment, the exhaust port 64 is located in a calf area of the leg. Typically, the calf area is the location where a larger percentage of moisture accumulates during compression treatment. The exhaust port 64 could be located in a different area of the leg without departing from the scope of the present invention. Referring to FIG. 8 , the exhaust port 64 may be positioned directly over an opening 36 in the bladder layers 18 , 20 to increase the amount of air that impinges upon the leg. When the controller 14 includes multiple exhaust ports 64 , they can be generally aligned with an opening 36 . If the compression device is configured so that the controller is not mounted directly on the sleeve, an exhaust port of the controller can be in fluid communication with an exterior surface of the sleeve through tubing 68 ( FIG. 9 ) extending from the exhaust port 64 to the sleeve 12 . The tubing can be positioned such that the vented air is directed through an opening 36 in the bladder layers 18 , 20 ( FIG. 4 ). Referring to FIG. 10 , fluid impermeable sheets 70 (e.g., plastic sheets) can be welded (e.g., by RF welding) around the openings 36 that receive the vented fluid. In FIG. 10 the opening 36 is circular, but can also be teardrop-shaped as shown in FIGS. 3 and 4 . The sheets 70 can be welded to an inner surface of the first intermediate layer 18 and around the opening 36 as shown to form three fluid channels 72 for directing fluid entering the opening 36 away from the opening. The channels 72 guide the air to facilitate the cooling of areas of the wearer's skin that are not directly below the opening 36 . For example, it is envisioned that the channels 70 can be formed to guide air toward a back of the wear's calf where more perspiration may be present. Although the sheet 70 is welded to form three channels 72 in the illustrated embodiment, those skilled in the art will appreciate that fewer or more channels may be formed or the sheets may be embossed with dimples to provide multiple airways. As will also be appreciated, the sheet-and-channel configuration may be broadly referred to as a guide. Having described the invention in detail, it will be apparent that modifications and variations are possible without departing from the scope of the invention defined in the appended claims. When introducing elements of the present invention or the preferred embodiments(s) thereof, the articles “a”, “an”, “the”, and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including”, and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained. As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention concerns coffee, tea, cocoa, and other beverages containing milk constituents, and particularly concerns stabilized milk-constituent-containing beverages in which the germination of spores of and proliferation of heat-resistant spore-forming bacteria are inhibited and in which problems such as coagulation, oiling off, feathering, precipitation, neck ring, etc. of the milk constituents contained are suppressed. The present invention applies to milk-constituent-containing beverages which are preserved and distributed in metal cans, such as aluminum cans, steel cans, etc., bottles, such as glass, ceramic, etc., and various other containers made of paper, synthetic resin, etc. 2. Description of the Prior Arts Many beverages such as coffee, tea, cocoa, etc. contain milk constituents to improve flavor generally used, and taste, etc. The milk constituents used vary widely in type and amount, and include raw milk, raw cream, whole milk powder, skim milk powder, or instant creaming powder (ICP). When stored over long periods of time, beverages containing milk constituents undergo loss of potable aptitude ( marketability) due to such problems as separation, oiling off, feathering, precipitation, neck ring, etc. of the milk constituents. Also, although milk-constituent-containing beverages are usually sterilized by retorting, there are cases where the spores of heat-resistant spore-forming bacteria survive under the conditions of such treatment. In cases where milk-constituent-containing beverages are sold or stored under low-temperature storage conditions in a vending machine, etc., there is little possibility of germination of spores of and proliferation of the surviving heat-resistant spore-forming bacteria and quality problems do not occur. However, if such beverages are placed in a heated condition, for example at 55° C., the surviving spores of heat-resistant spore-forming bacteria can germinate and proliferate to cause the beverage contents to deteriorate and the beverage to thus lose potable aptitude ( marketability). The combined use of a polyglycerin monoesters of fatty acids, comprising lauric acid and myristic acid, and mono-and diglycerides of fatty acids (laid-open Japanese patent publication No. Hei6-121640), the combined use of sucrose esters of fatty acids and citric acid esters of mono-and diglycerides of fatty acids (laid-open Japanese patent publication No. Hei5-15349), etc. have been proposed as methods of preventing deterioration and putrefaction of the beverage contents through prevention of germination of spores of and proliferation heat-resistant spore-forming bacteria and preventing undesirable effects due to physicochemical changes at the same time. However, with the former of the above methods, not only does the lauric acid, which is a lower fatty acid, damage the flavor significantly but the antibacterial effects are also inadequate. With the latter method, since sucrose esters of fatty acids is used, the effects of preventing the germination of spores of and proliferation of heat-resistant spore-forming bacteria are inadequate and unsatisfactory. The present inventors have previously proposed the milk-constituent-containing beverage disclosed in Japanese patent application No. Hei7-144075 (laid-open Japanese patent application No. Hei8-228676). This prior art discloses a milk-constituent-containing beverage that uses diglycerol monoesters of fatty acids as emulsifier and is characterized in that 70wt. % or more of the fatty acid composition of the diglycerol monoesters of fatty acids is taken up by the total amount of myristic acid and/or palmitic acid. With this prior art, the germination of spores of and proliferation of heat-resistant spore-forming bacteria can be suppressed even when the beverage is stored at a high temperature over long periods. SUMMARY OF THE INVENTION With regard to the above mentioned prior arts, the present inventors proposed that mono-and diglycerides of fatty acids, lecithin, or other known emulsifier may be used in combination. The present inventors continued further research on this prior art. As a result, we were able to make the surprising discovery that, by selecting and making combined use of specific emulsifiers among known emulsifiers, not only can heat-resistant spore-forming bacteria growth inhibition effects be provided but the coagulation, oiling off, feathering, precipitation, and neck ring of the milk constituents can also be suppressed. As is clear from the above, the object of the present invention is to provide a milk-constituent-containing beverage for which the germination of spores of and proliferation heat-resistant spore-forming bacteria are suppressed and for which physicochemical changes of the beverage contents are prevented over long periods, even though the beverage may be a milk-constituent-beverage for which the death rate of the spores of heat-resistant spore-forming bacteria surviving in the beverage is improved without raising the sterilization temperature conditions or a milk-constituent-containing beverage which is stored over long periods under high-temperature conditions. In the invention, "feathering" means that feather-like coagulation arises when cream is added to coffee. Furthermore, "oiling off" means that oil drops are joined together to become large, whereby oil is separated from the base material. Still furthermore, "neck ring" means that white rings are formed, the main constituents of which are fat and protein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention shall now be described in detail. First, the abovementioned component (A) used in the present invention shall be described. The diglycerol monoesters of fatty acids used in the present invention can be obtained by preparing an ester mixture through esterification of diglycerol monoesters of fatty acids and fatty acids, transesterification of diglycerol monoesters of fatty acids and fatty acids and methyl esters of fatty acids or other esters, esterification of glycerol by fatty acid halides, etc. and then performing separation and purification by a method such as distillation fractionation, adsorption chromatography separation, liquid-liquid extraction separation, etc. Diglycerol monoesters of fatty acids suitable for the present purpose can usually be obtained efficiently and economically by the molecular distillation method. However, the present invention is not limited to these methods. The constituent fatty acids of the diglycerol monoesters of fatty acids to be used in the milk-constituent-containing beverage by the present invention are mainly comprised of myristic acid and/or palmitic acid, the total amount of which comprises 70 wt.% or more and preferably 90 wt.% or more of the constituent fatty acids. It is unfavorable for the total amount to be less than 70 wt.% since the effect of suppressing the germination of spores of and proliferation heat-resistant spore-forming bacteria will be inadequate in this case. The monoester content of the ester mixture in the diglycerol monoesters of fatty acids used in the present invention is 70 wt% or more and preferably 80 wt% or more. It is unfavorable for the monoester content to be less than 70 wt% since the effect of suppressing the germination of spores of and proliferation heatresistant spore-forming bacteria will be inadequate in this case. The diglycerol monoesters of fatty acids used in the present invention may be added directly to the milk-constituent-containing beverage or may be added by mixing in the water or milk-constituent that comprises the milk-constituent-containing beverage. The added amount of the diglycerol monoesters of fatty acids used in the present invention is 0.01 to 1.0 wt.% or preferably 0.01 to 0.5 wt% to 1 part of milk-constituent-containing beverage. If the added amount is less than 0.01 wt.%, the effect of suppressing the germination of spores of and proliferation heat-resistant spore-forming bacteria will be inadequate, and if the added amount is greater than 1.0 wt.%, there will be an undesirable effect on the flavor. The abovementioned component (B) used in the present invention shall be described next. The citric acid esters of mono-and diglycerides of fatty acids, succinic acid esters of mono-and diglycerides of fatty acids, or diacetytartaric acid esters of mono-and diglycerides of fatty acids used in the present invention is a mixed ester of (a) glycerol, (b) fatty acids, and (c) citric acid, succinic acid, or diacetyl tartaric acid, and the fatty acid constituents of the ester are saturated and/or unsaturated fatty acids with 12 to 22 carbons. The polyglycerin monoesters of fatty acids used in the present invention is an ester of polyglycerol and fatty acids, and is preferably an ester of polyglycerol with an average degree of polymerization of 3 or more and saturated and/or unsaturated fatty acids with 12 to 22 carbons. The polyglycerin monoester of fatty acids has an HLB of 3 to 16. The sucrose esters of fatty acids to be used in the present invention is an esterification product of sucrose and fatty acids, and though the fatty acids thereof can be saturated and/or unsaturated fatty acids with 12 to 22 carbons, it is especially preferable for the fatty acids to be saturated fatty acids. The sucrose esters of fatty acids have an HLB of 3 to 16. As component (B) of the present invention, one or more esters is selected from among a group comprised of citric acid esters of mono-and diglycerides of fatty acids, succinic acid esters of mono-and diglycerides of fatty acids, diacetyltartaric acid esters of mono-and diglycerides of fatty acids, polyglycerin monoester of fatty acids with an HLB of 3 to 16, and sucrose fatty acid esters with an HLB of 3 to 16. The total amount of component (B) added to the milk-constituent-containing beverage is 0.002 to 0.3 wt% and preferably 0.01 to 0.15 wt% . With an added amount of less than 0.002 wt% , the purported effects of preventing coagulation, oiling off, feathering, precipitation, etc. of milk constituents cannot be exhibited satisfactorily. An added amount of more than 0.3 wt% not only brings about an undesirable effect on the flavor and taste but is also uneconomical since the purported effects will not be improved. By containing (A) diglycerol monoesters of fatty acids and (B) at least one emulsifier selected from a group comprised of citric acid esters of mono-and diglycerides of fatty acids, succinic acid esters of mono-and diglycerides of fatty acids, diacetyltartaric acid esters of fatty acids, polyglycerin monoesters of fatty acids with an HLB of 3 to 16, and sucrose esters of fatty acids with an HLB of 3 to 16, the milk-constituent-containing beverage of the present invention becomes a beverage with good storage properties in which the germination of spores of and proliferation heat-resistant spore-forming bacteria are suppressed, flat sour deterioration is prevented, coagulation, oiling off, feathering, precipitation, etc. of the milk constituents will not occur, and the flavor and taste will not be damaged even when the beyerage is stored under high temperature over long periods of time. As long as the milk-constituent-containing beverage of the present invention contains the emulsifier (A) and the emulsifier (B) used in the present invention, emulsifiers besides those used in the invention may be used within quantiry ranges which will not damage the effects of the invention. EXAMPLES The milk-constituent-containing beverage of the present invention shall now be described by way of examples and comparison examples. Examples 1-6 and Comparison Examples 1-12 4 kg of coffee bean extract, 0.8 kg of granulated sugar, 4 kg of raw milk were mixed to make a coffee-milk beverage. A total of 15 g of the emulsifiers shown in Table 1 where then added (milk fat content: 1.5%) to this coffee-milk beverage. After preliminary emulsification, the drink was homogenized at 150 kg/cm 2 with a piston homogenizer. Forty 250 ml of the coffee-milk beverage were then dispensed into each 40 test vessels. And 1 ml of a spore suspension (B. stearothermophilus, concentration: 1×10 4 spores/ml) was added to each test vessels. The test vessels were then heat sterilized for 1 minute at 121° C. and stored for 30 days at 55° C. The number of aliquots among the forty test vessels which had undergone deterioration or decomposition was then counted. The results are shown in Tables 1 and 2. At the same time, oiling off, feathering, precipitation, and neck ring were observed for the coffee-milk beverage test vessels which had not undergone deterioration due to the heat-resistant spore-forming bacteria. These results are also shown in Tables 1 and 2. Examples 7-9 and Comparison Examples 13-20 7.6 kg of coffee bean extract, 600 g of granulated sugar, 960 ml of raw milk, 830 g of whole milk powder, and 10 g of sodium bicarbonate were mixed to make a coffee-milk drink. A total of 10 g of the emulsifiers shown in Table 2 where then added (milk fat content: 2.5%) to this coffee-milk drink. After preliminary emulsification, the drink was homogenized at 150 kg/cm 2 with a piston homogenizer. Forty 250 ml of the coffee-milkk beverage were then dispensed and 1 ml of a spore suspension (C. thermoaceticum, concentration: 1×10 4 spores/ml) was added to each test vessels. The test vessels were then heat sterilized for 20 minutes at 121° C. and stored for 30 days at 55° C. The number of test vessels among the forty test vessels which had undergone deterioration or decomposition was then counted. The results are shown in Tables 3 and 4. At the same time, oiling off, feathering, precipitation, and neck ring were observed for the coffee-milk beverage test vessels which had not undergone deterioration due to the heat-resistant spore-forming bacteria. These results are also shown in Tables 3 and 4. TABLE 1______________________________________Types of emulsifier(See Note 2), Figures in Evaluation itemsEx. the ( ) are the contents (See Note 1)No. (wt. %). A B C D E______________________________________1 A1(0.05) B1(0.1) -- 0 ⊚ ⊚ ◯⊚ ⊚2 A1(0.05) B1(0.07) B2(0.03) 0 ⊚ ⊚ ⊚ ⊚3 A2(0.05) B3(0.1) -- 0 ◯⊚ ⊚ ◯⊚ ⊚4 A2(0.05) B4(0.1) -- 0 ◯⊚ ◯⊚ ◯⊚ ◯.circleincirc le.5 A3(0.05) B5(0.1) -- 0 ⊚ ◯ ⊚ ⊚6 A4(0.05) B1(0.1) -- 0 ⊚ ⊚ ⊚ ⊚______________________________________ Note 1: Evaluation items A = number of test vessels among the 40 test vessels that underwent deterioration, B = feathering, C = oiling off, D = precipitation, and E = neck ring, the following evaluation standards were used. When two symbols are indicated, this means that the condition is intermediate those corresponding to the two symbols. ⊚ = Unobserved, ◯ = Observed slightly, □ = Observed clearly but in small quantities, Δ = Observed in large quantities and X = Impossible to evaluate. Note 2: Types of emulsifier A1 Diglycerol monoesters of fatty acids Constituent fatty acids: palmitic acid 99 wt. % Monoester content: 85 wt. % A2 Diglycerol monoesters of fatty acids Constituent fatty acids: myristic acid 99 wt. % Monoester content: 80 wt. % A3 Diglycerol monoesters of fatty acids Constituent fatty acids: myristic acid 99 wt. % Monoester content: 85 wt. % A4 Diglycerol monoesters of fatty acids Constituent fatty acids: palmitic acid 55 wt. % myristic acid 45 wt. % Monoester content: 80 wt. % B1 Diacetyltartaric acid esters of monoand diglycerides of fatty acids (Used POEM W10 made by Riken Vitamin Co.) Constituent fatty acids: steari acid 70 wt. %, palmitic acid 30 wt. % B2 Polyglycerin monoesters of fatty acids (Used POEM J0381 made by Riken Vitamin Co.) Constituent fatty acids: oleic acid 80 wt. % HLB:12 B3 Succinic acid esters of monoand diglycerides of fatty acids (Used POEM B10 made by Riken Vitamin Co.) Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B4 Citric acid esters of monoand diglycerides of fatty acids (Used POEM K30 made by Riken Vitamin Co.) Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B5 Sucrose esters of fatty acids (Used RYOTO S1570 made by Mitsubishi Chemical Corp.) Constituent fatty acids: stearic acid 70 wt. % HLB: 15 TABLE 2______________________________________Com-par-ison Types of emulsifier Evaluation itemsEx. (See Note 4, Figures in the (See Note 3)No. ( ) are the contents (wt. %). A B C D E______________________________________1 A1(0.05) B'11(0.1) -- 0 Δ□ ◯ □◯ □2 A1(0.05) B'12(0.1) -- 0 □ ◯⊚ □ ◯3 A1(0.05) B'13(0.1) 0 □ ◯ □ □4 A'11(0.05) B1(0.1) -- 14 ⊚ ⊚ ◯⊚ ⊚5 A'12(0.05) B'13(0.03) B'14 21 Δ□ □ □◯ Δ (0.07)6 A'13(0.05) B'11(0.1) -- 10 Δ□ ◯ □ Δ□7 A'14(0.05) B'15(0.1) -- 18 Δ Δ□ Δ□ Δ8 A'15(0.05) B1(0.1) -- 40 x x x x9 -- B1(0.1) B'16 31 ◯⊚ ◯⊚ ⊚ ◯ (0.05)10 -- B1(0.1) B7 40 x x x x (0.05)11 -- B1(0.1) B8 37 ⊚ ⊚ ◯ ⊚ (0.05)12 -- B1(0.1) B9 40 x x x x (0.05)______________________________________ Note 3: Evaluation items, see Note 1 of Table 1. Note 4: Types of emulsifier A'11 Diglycerol monoesters of faty acids Constituent fatty acids: lauric acid 99 wt. % Monoester content: 90 wt. % A'12 Diglycerol monoesters of faty acids Constituent fatty acids: oleic acid 99 wt. % Monoester content: 90 wt. % A'13 Diglycerol monoesters of faty acids Constituent fatty acids: palmiti acid 55 wt. % stearic acid 45 wt. % Monoester content: 80 wt. % A'14 Diglycerol monoesters of faty acids Constituent fatty acids: myristi acid 99 wt. % Monoester content: 40 wt. % A'15 Diglycerol monoesters of faty acids Constituent fatty acids: palmiti acid 45 wt. % stearic acid 55 wt. % Monoester content: 35 wt. % B6 Citric acid esters of monoand diglycerides of fatty acids Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B'11 Lecithin (Used DX lecithin made by Nisshin Seiu Co.) B'12 Sorbitan esters of fatty acids (Used POEM S300B made by Riken Vitami Co., Ltd.) Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B'13 Monoand diglycerides of fatty acids (Used EMULSEEMS made by Riken Vitamin Co., Ltd.) Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B'14 Polyglycerin monoesters of fatty acids (Used POEM J0080 made by Rike Vitamin Co., Ltd.) Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B'15 Polyglycerol esters of polycondensed ricinoleic acid. (Used POEM PR300 made by Riken Vitamin Co., Ltd.) HLB: 0.3 B'16 Polyglycerin monoesters of fatty acids (Used POEM J0021 made by Rike Vitamin Co., Ltd.) Constituent fatty acids: lauric acid 99 wt. % HLB: 15 B7 Polyglycerin monoesters of fatty acids (Used POEM J0041 made by Riken Vitamin Co., Ltd.) Constituent fatty acids: myristic acid 99 wt. % HLB: 1 B8 Sucrose esters of fatty acids (Used RYOTO P1670 made by Mitsubishi Chemical Corp.) Constituent fatty acids: palmitic acid 80 wt. % HLB 16 TABLE 3______________________________________Types of emulsifier Evaluation items(See Note 6), Figures in (See Note 5)Ex. No. the ( ) are the contents (wt. %). A B C D E______________________________________7 A2(0.005) B1(0.05) -- 0 ◯⊚ ⊚ ◯⊚ 6 ⊚8 A2(0.005) B1(0.035) B2(0.015) 0 ⊚ ⊚ ⊚ ⊚9 A1(0.05) B4(0.05) 0 ⊚ ⊚ ◯⊚ ⊚______________________________________ Note 5: Evaluation items, see Note 1 of Table 1. Note 6: Types of emulsifier, see Note 2 of Table 1. TABLE 4______________________________________Compa- Types of emulsifier Evaluation itemsrison (See Note 4), Figures in the (See Note 3)Ex. No. ( ) are the contents (wt. %). A B C D E______________________________________13 A1(0.05) B'21(0.05) -- 0 □ ◯ □◯ Δ□14 A1(0.05) B1(0.035) B'22 0 Δ□ □◯ □ Δ (0.015)15 A'16(0.05) B1(0.05) -- 16 ◯⊚ ⊚ ◯⊚ ◯.circleincirc le.16 A'17(0.05) B'23(0.05) -- 9 Δ□ □ □ Δ17 A'18(0.05) B'24(0.05) -- 25 Δ Δ x Δ18 -- B1(0.05) B7 30 ◯ ⊚ ◯ ◯ (0.05)19 -- B1(0.05) BB9 5 ⊚ ◯⊚ ⊚ ⊚ (0.05)20 A1(0.05) B'25(0.05) -- 0 Δ Δ□ Δ Δ______________________________________ Note 7: Evaluation items, see Note 1 of Table 1. Note 8: Types of emulsifier A'16 Diglycerol monoesters of fatty acids Constituent fatty acids: lauric acid 99 wt. % Monoester content: 90 wt. % A'17 Diglycerol monoesters of fatty acids Constituent fatty acids: palmitic acid 55 wt. % stearic acid 45 wt. % Monoester content: 70 wt. % A'18 Diglycerol monoesters of fatty acids Constituent fatty acids: myristic acid 99 wt. % Monoester content: 40 wt. % B'21 Lecithin (Used DX Lecithin made by Nisshin Seiu Co.) B'22 Monoand diglycerides of fatty acids (Used EMULSEEHRO made by Riken Vitamin Co., Ltd.) Constituent fatty acids: oleic acid 75 wt. % B'23 Lecithin (Used Lecithin PK made by Riken Vitamin Co.) B'24 Sucrose esters of fatty acids (Used RYOTO ER290 made by Mitsubishi Chemical Corp.) Constituent fatty acids: erucic acid 90 wt. % B'25 Propylen glycol esters of fatty acids (Used RIKEMUL PS100 made by Riken Vitamin Co.) Constituent fatty acids: stearic acid 70 wt. %, palmitic acid 30 wt. % B9 Sucrose esters of fatty acids (Used RYOTO P1670 made by Mitsubishi Chemical Corp.) Constituent fatty acids: palmitic acid 80 wt. % HBL: 16 As the above, with the milk-constituent-containing beverage by the present invention, since the germination of spores of and proliferation heat-resistant spore-forming bacteria are suppressed, flat sour deterioration is prevented, and problems such as coagulation, oiling off, feathering, precipitation, neck ring, etc. of the milk constituents do not occur, the problems mentioned above are solved even for cases where the beverage is stored under heated conditions in a vending machine, etc.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10/258,380, filed Oct. 23, 2002, which is the U.S. National Stage entry of International Application No. PCT/GB01/01998, filed May 4, 2001, which claims priority to United Kingdom Patent Application No. GB 0011053.6, filed May 9, 2000, now abandoned, the complete disclosures of which are incorporated herein by reference for all purposes. BACKGROUND OF THE INVENTION [0002] The present invention relates to apparatus and methods for packing nasal cavities. In particular, the present invention relates to a nasal haemostatic device for packing and supporting the nasal cavities after surgical procedures performed on the nose. [0003] In certain plastic surgical procedures, and in certain plastic surgery (rhinoplasty and septoplasty), it is necessary to cut and modify the nasal septum, that is, the cartilage-like material which separates the left and right chambers of the nose. [0004] There is a technical problem with known nasal packing materials because it is difficult to pack the nasal cavity in a manner that not only ensures good healing but also equal healing on each side of the nasal septum. Moreover, unless great skill is used by the physician, one side of the septum may be packed more tightly than the other side thus causing deformation of the healed septum. Such a deformity is typically regarded as unacceptable by the patient, particularly if the operation was for cosmetic purposes, that is, plastic surgery. [0005] Accordingly, there is a need for improved methods and apparatus for packing nasal cavities. SUMMARY OF THE PREFERRED EMBODIMENTS [0006] According to a first aspect, the present invention provides a kit for packing nasal cavities comprising two inflatable non-elastomeric balloons and inflation means arranged so that, in use, each balloon can be located in a nasal cavity and inflated. [0007] In use, the balloons are inserted in the left and right chambers of the nose respectively and each balloon inflated. This allows the physician to control the amount of pressure applied to each side of the septum to avoid any possible deformity to the nose. [0008] According to a first embodiment, the inflation means comprises two separate inflation lines, each balloon is connectable to a separate inflation line and each balloon is connectable to a single inflation port by the two separate inflation lines. Preferably, the inflation lines are arranged so that, in use, each balloon is inflated to an identical pressure. This ensures that exactly the same pressure is applied to each side of the septum to avoid any possible deformity to the nose. Moreover, as the method is not reliant on the skill and expertise of a particular physician the apparatus will therefore be more appealing for use by a range of users. [0009] According to a second embodiment, the inflation means comprises a single common inflation line and each balloon is connectable to a single inflation port by the single common inflation line. Preferably, the inflation line is arranged so that, in use, each balloon is inflated to an identical pressure. [0010] The haemostatic nasal packing device according to the second embodiment of the invention allows the user to pack both the anterior and posterior nasal chamber of a single nostril simultaneously following surgical procedures. Moreover, each of the two balloons may be inflated to identical pressures thereby ensuring that exactly the same pressure is applied to the anterior and posterior nasal chamber thus mitigating any possible deformity to the nose. [0011] Preferably, the kit of the present invention includes at least one pressure control means for automatically controlling inflation of the balloons so that each balloon is inflated to an identical predetermined pressure. [0012] According to a third embodiment, the inflation means comprises two separate inflation lines, each balloon is connectable to a separate inflation line and each inflation line includes at least one pressure control means for automatically controlling inflation of the balloon connected thereto so that the balloon is inflated to a predetermined pressure. [0013] The term “automatically controlling the inflation of the balloon so that the balloon is inflated to a predetermined pressure” means that the balloon is inflated to a preselected pressure level without the need for monitoring and/or control by a physician or other users of the device. [0014] The automatic control means solves the technical problem of ensuring that the pressure in the non-elastomeric balloons do not exceed a specific preselected value. This reduces the risk of side effects such as trauma and toxic shock syndrome. Moreover, as the method is not reliant on the skill and expertise of a particular physician the apparatus will therefore be more appealing for use by a range of users. The methods of the invention should result in improved patient compliance compared to alternative surgical procedures. [0015] Still further if separate pressure control means are used and both are preset to different predetermined pressure values then the user may apply different pressures to each side of the nasal septum to induce desirable shape changes during healing. [0016] Preferably, one or both of the balloons has a soft pliable wall made from a non-elastomeric polymeric material. [0017] It is well known to a skilled person in the art that all plastic polymers are elastic to some extent in the strict definition of the word, that is, they obey Hooke's Law and have the ability to return to their original shape after being deformed. However, it is the extent to which the polymers can be deformed which distinguishes non-elastomeric polymeric materials from elastomeric polymeric materials. [0018] By the term “elastomeric polymeric material” we include the meaning of a polymeric material which at room temperature can be stretched to at least twice its original length and upon immediate release of the stress will quickly return to approximately its original length. Examples of elastomeric polymeric materials include rubber and silicon rubber. [0019] By the term “non-elastomeric polymeric material” we include polymeric materials, such as nylon, which, although flexible, do not fall within the functional definition given above for elastomers. [0020] Preferably, one or both of the balloons has a fixed volume which ensures that the pressure in the balloon is independent of the volume of the balloon. The fixed volume non-elastomeric polymeric balloon of the device of the invention ensures that adverse effects associated with wall elasticity of known elastomeric balloons are eliminated or at least substantially mitigated, as all of or most of the pressure within the balloon is directly applied to the wall of the body cavity. [0021] Preferably, the diameter, length and volume of each of the balloons is designed to be slightly greater than that of a nasal cavity likely to be packed during a particular surgical procedure. More preferably, the balloon has a diameter of between 10 mm and 75 mm, a length of between 5 mm and 100 mm and a volume of between 0.5 ml.sup.3 and 450 ml.sup.3. [0022] Preferably, the pressure control means comprises an electrical pressure transducer, well known to a person skilled in the art, which constantly monitors the pressure in the balloons using an electronic instrument. Preferably, the arrangement is directly linked to an electrical inflation device which is programmed to increase the pressure in the balloons to the required predetermined value, and automatically hold it at that value. [0023] Alternatively, the pressure monitoring means comprises a valve that is operable to prevent further inflation of the balloons when the balloons are inflated to the predetermined pressure. More preferably, the valve is a pressure relief valve which is pre-set at the required pressure value and will vent pressure medium when balloon pressure reaches its pre-set value. Most preferably, the valve comprises a tubular member having an outlet in the side wall, a valve cover releasably sealing the outlet and moveable between a sealing position and an open position, and a resilient biasing means, such as a spring, for biasing the valve cover towards the sealing position so that the valve cover moves to the open position when the balloons are inflated above the predetermined pressure. Since the inflation medium is usually air, venting of excess pressure to the atmosphere is most convenient. [0024] Silicone rubber which is used in some elastomeric balloons is permeable to air. Such silicone balloons cannot be inflated with air if inflation is to be sustained. If sustained inflation must be maintained, a silicone balloon must be inflated with a liquid medium such as water or a saline solution. [0025] If air is used as the inflation medium, then non-elastomeric balloons used in the apparatus of the present invention must not be permeable to air. A suitable material is polyvinyl chloride (PVC), but other suitable materials may be used. [0026] Although the relationship between volume and pressure is not linear when using an elastic inflation medium such as air, because the pressure control means is only dependent on the pressure within the balloons this non-linear behaviour of an elastic inflation medium does not affect the operation of the apparatus of the present invention. [0027] By increasing or decreasing the force of the resilient biasing means it is possible to adjust the desirable preset pressure value in the balloons in a quick and cost effective manner. Preferably, the resilient biasing means comprises a spring load pin. The pressure value at which the valve cover will move to the open position thereby allowing the balloons to deflate is dependent on the tension of the spring and the cross-sectional area of the valve opening. Since the valve cover is only held in place by the spring, the apparatus is practically fail safe. Such valves are well known to a person skilled in the art. [0028] In use, a user may use a syringe or a bladder type hand pump which has a larger capacity than that required to inflate the balloon to the predetermined pressure. The syringe is slowly operated to its maximum but the pressure relief valve will vent when the predetermined pressure value is reached. Hence, the balloons are inflated to the required pressure in a simple operation, without any skill or independent pressure control by the user. [0029] Conveniently, a restriction means is provided in the inflation lines distal to the pressure relief valve so that inflation is not carried out too quickly, that is, faster than the venting capacity of the relief valve. [0030] Alternatively, the pressure control means comprises a separate portable pressurised container that is charged with a pressurised inflation medium, such as compressed air. The pressurised inflation medium is charged to a specific value so that when it is connected to the inflation line, the inflatable balloons are charged to a predetermined pressure. It will be apparent to a skilled person in the art that there must be sufficient pressurised inflation medium in the container to counterbalance the pressure drop that will occur by filling the balloons. [0031] In a particular preferred arrangement the pressure control means is operable to permit automatic controlled inflation of, the balloons to at least two predetermined pressures. A particular advantage of such an arrangement is that this allows the balloons to be inflated to a relatively high initial pressure following insertion to attain immediate haemostasis. After this effect has been achieved, typically after 20 to 30 minutes, the pressure in the balloons can be reduced to mitigate possible side-effects such as trauma due to prolonged residence of the balloons in the nasal cavities. [0032] Most preferably, this type of dual pressure inflation arrangement comprises two pressure relief valves, as mentioned hereinbefore, namely a first pressure relief valve that is operable to prevent further inflation of the balloon when the balloons are inflated to the initial predetermined pressure (initially up to 25 KPa); and a second pressure relief valve for reducing the pressure in the inflated balloons to a lower predetermined pressure (between 4 to 12 KPa). This type of arrangement further includes a switching means for independently switching between each of the valves to permit the balloons to be automatically inflated to different predetermined pressures. [0033] Preferably, the switching means is a standard change over valve which may be located either on the input or exhaust side of the pressure relief valves. In use, the change over valve should initially be set so that the high pressure relief valve is in line with the balloons. After the balloon has been inflated, for example with air, for approximately 20 minutes the change over valve can be moved so that the low pressure relief valve is in line with the balloon to allow the balloon to deflate to a lower predetermined pressure. [0034] Alternatively, the dual pressure inflation arrangement may contain a single pressure relief valve which is adapted to permit selective inflation/deflation of the balloons. For example, the tubular member of the pressure relief valve as mentioned hereinbefore may comprise two outlets each of which are releasably sealed by a valve cover. Each valve cover may be biased towards the closed position for example by two separate spring load pin arrangements, as described hereinbefore. Each of the spring loaded pins may have different tensions ie a different spring rate, and/or each of the valve openings/valve covers may have different cross-sectional areas, so that each cover opens at a different predetermined pressure. In this arrangement, the switching means permits selective communication between the balloons, inflation means and independently each outlet of the pressure relief valve. [0035] In both of the dual pressure inflation arrangements including the pressure relief valves, the switching means may comprise removable valve caps sealing the valve outlets. In use, the balloons can be inflated/deflated to the desired predetermined pressure by simply alternately removing and replacing the valve caps. [0036] The device including two separate inflation lines connected to a common inflation port may have a separate pressure control means located in each inflation line or a single common pressure control means located at the proximal end of both inflation lines. [0037] Preferably, the apparatus also includes a delivery means. Preferably, the delivery means for inserting the balloons into the nasal chambers is a catheter which includes the inflation line. [0038] Preferably, the pressure control means is located in the inflation line of the delivery means so that in, use the pressure control means remains outside the patient's body, thereby increasing patient compliance. More preferably, the inflation line includes a restriction distal to the pressure relief valve to ensure that the balloons are not inflated too quickly, in particular so that the balloons are not inflated faster than the venting capacity of the relief valve. This provides the advantage of providing a further additional safety feature to ensure that the balloons are not over inflated. [0039] Preferably, the apparatus includes a non-return valve such as a luer slip valve proximal to the restriction. Preferably, the luer slip valve is opened by the tip of the inflation device ie the syringe to allow the balloons to be inflated and the luer slip valve closes on removal of the inflation device to ensure that the inflated balloons do not deflate completely. It will be appreciated that the inflation device ie the syringe could also be used to deflate an inflated balloon by withdrawing the barrel of the syringe. [0040] Alternatively, the luer slip valve may be operable to permit deflation of an inflated balloon. [0041] Preferably, one or both of the balloons are releasably connected to the delivery means and one or both of the balloons are associated with an agent that retards or prevents bleeding. [0042] The term “an agent that retards or prevents bleeding” includes any haemostatic agent that is capable of arresting, stemming or preventing bleeding by means other than inducing tissue growth alone. In other words, it is not tissue growth alone which is responsible for retarding or preventing bleeding. It will of course be appreciated that the haemostatic agent may have the beneficial property of inducing tissue growth in addition to its retardation or prevention of bleeding property. [0043] Preferably, the haemostatic agent is a bioactive compound or composition which causes vasoconstriction and/or blood coagulation. [0044] Examples of preferred haemostatic agents that retard or prevent bleeding include oxidised cellulose, such as Tabotamp.™. sold by Johnson and Johnson, calcium alginate, gelatine or collagen. A particularly preferred agent is carboxymethylated cellulose which can be purchased from Courtaulds Special Fibres, PO Box 111, 101 Lockhurst Lane, Coventry, England, CV6 5RS. Combinations of different agents may be used within the scope of the invention. [0045] Preferably, the haemostatic agent that retards or prevents bleeding is provided in the form of a net or knitted, especially a weft knitted, textile material that envelopes one or both of the balloons. More preferably, the net or knitted textile material is fixed to the balloon(s) and/or has a roughened surface to promote growth of fibrous tissue around the outer surface of the balloon(s) thereby anchoring it to the interior wall of the body cavity. [0046] Alternatively, the haemostatic agent that retards or prevents bleeding is provided in the form of a flexible film that coats the outer surface of the balloon(s). Preferably, the flexible film has a roughened surface to promote tissue growth. [0047] However, it will be appreciated that if the haemostatic agent which prevents or retards bleeding is either in itself or in conjunction with the pressure exerted by the balloons relatively fast-acting, the balloon can be fixed to the delivery means and can simply be pushed inside the nasal cavity until the bleeding has been prevented or retarded and then removed is after the repaired septum has healed. [0048] The invention will be further described with reference to the following non-limiting examples and drawings wherein: DESCRIPTION OF THE DRAWINGS [0049] FIG. 1 is a side view, partially cross sectioned, of a typical luer slip valve; [0050] FIG. 2 is a plan view of the end of the valve in FIG. 1 taken along the line A-A; [0051] FIG. 3 is the luer slip valve of FIG. 1 incorporated into a safety cuff or pilot balloon; [0052] FIG. 4 is a plan view of the pilot balloon and valve shown in FIG. 3 taken along the line B-B; [0053] FIG. 5 is the first embodiment of the invention with the dual inflatable balloons connected to a single inflation port by separate inflation lines; [0054] FIG. 6 is another embodiment of the invention with the dual inflatable balloons connected to a single inflation port by a single common inflation line; [0055] FIG. 7 is the same as FIG. 6 except the balloons include a haemostatic net; [0056] FIG. 8 is a typical pressure relief valve; [0057] FIG. 9 shows the combination luer slip valve, pressure relief valve, the restriction, the pilot balloon and inflation line; and [0058] FIG. 10 shows two different pressure relief valves, and a sealing cap on the most proximal, and lowest pressure valve. DETAILED DESCRIPTION OF THE EMBODIMENTS [0059] 1. Standard Inflation Port [0060] There is shown in FIGS. 3 and 4 a typical inflation port arrangement ( 1 ) used in a known balloon inflation device suitable for treating a bleeding body cavity. The device ( 1 ) consists of a luer slip valve ( 2 ), a pilot balloon ( 3 ) or safety cuff ( 3 ) connectable to an inflation tube ( 4 ). [0061] As shown in FIGS. 1 and 2 the luer slip valve ( 2 ) includes a port ( 5 ) that opens upon insertion of a tip of a syringe and automatically closes when the syringe is removed. Such an arrangement allows a balloon (not shown) to be inflated with an inflation medium and to remain inflated upon removal of the syringe. [0062] It will be appreciated by a person skilled in the art that a bladder type hand pump fitted with a luer type inflation nozzle or a connector which is fitted to a syringe may be used instead of a syringe. [0063] 2. Device With Separate Inflation Lines [0064] There is shown in FIG. 5 a haemostatic nasal packing device comprising a typical inflation port arrangement ( 1 ) in combination with two inflatable elastomeric balloons ( 6 , 6 ′) each of which are in fluid communication with the pilot balloon ( 3 ) via separate inflation lines ( 4 , 4 ′). Typically, the inflation lines are about 40-50 mm long. [0065] Each of the balloons ( 6 , 6 ′)include a haemostatic fabric shroud ( 7 , 7 ′) secured to the distal tip of the respective balloon ( 6 , 6 ′) by a fabric ring clamp ( 8 , 8 ′). Each balloon is releasably mounted to a delivery catheter ( 9 , 9 ′). [0066] For packing the nasal cavities following a surgical procedure on the nose, the balloons ( 6 , 6 ′) and haemostatic fabric shroud ( 7 , 7 ′) are inserted into the left and right chambers of the nose respectively. A syringe containing air is inserted into the inflation port ( 5 ) of the luer slip valve ( 2 ) and air introduced into the apparatus. Both balloons are inflated to identical pressures i.e. between 4 to 25 Kpa. [0067] This enables haemostasis to be achieved and ensures that exactly the same pressure is applied to each side of the septum therefore mitigating any possible deformity to the nose. After the septum has healed the balloons ( 6 , 6 ′) are deflated by inserting a syringe into the inflation port ( 5 ) of the luer slip valve ( 2 ) and withdrawing the barrel of the syringe. The balloons ( 6 , 6 ′) are then removed from the nose. [0068] 3. Device With a Single Inflation Line [0069] There is shown in FIGS. 6 and 7 a nasal packing device comprising a typical inflation port arrangement ( 1 ) in combination with two inflatable elastomeric balloons ( 6 , 6 ′) each of which are in fluid communication with the pilot balloon ( 3 ) via a single common inflation line ( 4 ). Typically, the inflation line is about 40-50 mm long. [0070] The two separate balloons ( 6 , 6 ′) are mounted on a common delivery catheter ( 9 ) and as illustrated in FIG. 7 the two balloons ( 6 , 6 ′) include a haemostatic fabric shroud ( 7 ) secured to the distal tip of the distal balloon ( 6 ) by a fabric ring clamp ( 8 ). [0071] Following a surgical procedure on the nose, the balloons ( 6 , 6 ′) are inserted into a single nasal cavity. The balloons of a complimentary device may also be inserted in the other nasal cavity. Inflation and deflation of the balloons may be achieved by following the procedure described hereinbefore (see Section 2 above). [0072] The nasal packing device not only ensures that both balloons ( 6 , 6 ′) are inflated to identical pressures but allows the user to pack both the anterior and posterior nasal chambers of a single nostril simultaneously. [0073] 4. Pressure Relief Valve [0074] A typical pressure relief valve ( 10 ) is shown in FIG. 8 . The pressure relief valve comprises a spring ( 25 ) which biases a sealing gasket ( 11 ) in towards a closed position against the pressure generated by the inflation medium in the main chamber ( 13 ). When the pressure in the main chamber ( 13 ) exerts a force on the sealing gasket ( 11 ) which exceeds the force exerted by the spring ( 25 ) biasing the sealing gasket ( 11 ) towards lo the closed position, the sealing gasket moves to an open position which allows the inflation medium to vent through the release vent ( 15 ). When the pressure of the inflation medium in the chamber ( 13 ) equals the force of the spring ( 25 ) exerted on the sealing gasket ( 11 ), the sealing gasket ( 11 ) will move from the open to the closed position. Thus the pressure relief valve allows a maximum predetermined pressure to be maintained in the chamber ( 13 ). The maximum predetermined pressure may be varied by changing the force exerted by the spring ( 25 ) on the sealing gasket ( 11 ) and/or by increasing/decreasing the cross-sectional area of the vent/sealing gasket ( 11 ). [0075] Preferably, the release vent ( 15 ) is in the form of a female luer fitting so that the exit ( 17 ) make be sealed with a male luer plug ( 19 ). [0076] 5. Single Pressure Relief Valve [0077] There is shown in FIG. 9 a preferred embodiment of an inflation port arrangement ( 21 ) for use with the apparatus of the present invention comprising a luer slip valve ( 2 ), a pressure relief valve ( 10 ), a pilot-balloon ( 3 ), an inflation line(s) ( 4 ) and a restriction ( 23 ) distal of the pressure relief valve ( 10 ). It will be appreciated that all parts of the inflation port arrangement ( 21 ) are in fluid communication with each other and the distal end of the inflation, line(s) ( 4 ) is connectable to the non-elastomeric inflatable balloons. [0078] The luer slip valve ( 2 ) allows air or another inflation medium to be introduced into the inflation tube ( 4 ) via a syringe, thereby inflating the non-elastomeric balloons. The pressure relief valve ( 10 ) will allow the inflation medium to vent from the system at a predetermined pressure as described hereinbefore. Hence, this inflation port arrangement ( 21 ) allows a user to inflate the balloons to a maximum pre-set pressure and to maintain the inflated balloon at that pressure (i.e. up to 25 KPa). [0079] The restriction ( 23 ) ensures that the pressure of the inflation medium ie air in the inflation tube(s) ( 4 ) does not rise above the predetermined maximum value as it prevents the inflation medium from being forced into the inflation tube ( 4 ) faster than the rate at which the vent ( 15 ) can vent excess pressure in the chamber ( 13 ). [0080] 6. Dual Pressure Relief Valve [0081] There is shown in FIG. 10 an alternative preferred embodiment of an inflation port arrangement ( 27 ) for use with the apparatus of the present invention comprising two pressure relief valves ( 10 ′, 10 ″), a luer slip valve ( 2 ), a pilot balloon ( 3 ), an inflation line(s) ( 4 ) and a restriction ( 23 ) distal of the pressure relief valves ( 10 ′, 10 ″). [0082] In FIG. 10 and FIG. 11 , the parts described herein before are indicated by the same reference numerals. [0083] The two pressure relief valves ( 10 ′, 10 ″) comprise a pressure relief valve ( 10 ′) which is adapted to vent at a lower predetermined pressure than the other pressure relief valve ( 10 ″). As mentioned above, this may be achieved by using springs ( 25 ′, 25 ″) having different tensions and sealing gaskets ( 11 ′, 11 ″) having different cross-sectional areas. This arrangement allows the inflatable balloons ( 6 , 6 ′) to be inflated to two different predetermined pressures. [0084] FIG. 11 illustrates the inflation port arrangement ( 27 ) in combination with two inflatable non-elastomeric balloons ( 6 ′, 6 ″) mounted on separate delivery catheters ( 9 , 9 ′) which are in fluid communication with the inflation lines ( 4 , 4 ′). [0085] As described hereinbefore, the balloons ( 6 , 6 ′) include a haemostatic fabric shroud ( 7 , 7 ′) secured to the distal tip of the balloons ( 6 , 6 ′) by a fabric ring clamp ( 8 , 8 ′). [0086] Following a surgical procedure, the balloons are inserted into the respective left and right chambers of the nose. The vent ( 15 ′) of the low pressure relief valve ( 10 ′) is initially capped with a male luer cap ( 19 ) to prevent the inflation medium ie air from venting through this valve ( 10 ′). The second higher pressure relief valve ( 10 ″) initially has its vent ( 15 ″) open. [0087] A syringe containing air is inserted into the inflation port ( 5 ) of the luer slip valve ( 2 ) and air introduced into the apparatus. The balloons ( 6 , 6 ′) inflate to the higher preset pressure limit, ie between 12 to 25 KPa, as determined by the higher pressure relief valve ( 10 ″) and remain inflated at this pressure. This high pressure relief valve ( 10 ″) may be configured so that the pressure in the balloons is slightly higher than normal blood pressure. This enables rapid haemostasis to be attained. [0088] After an initial haemostasis has been achieved the balloon may be deflated to the lower preset pressure, ie between 4 to 12 KPa, by removing the male luer cap ( 19 ) from the vent ( 15 ′) of the low pressure relief valve ( 10 ′). This allows the healing nasal cavity to stabilise, it is more comfortable for the patient, and it is less likely to cause medical complications ie deformation of the nasal cavity. [0089] It will be appreciated by a person skilled in the art that although the illustrations in this description have referred to standard luer fittings any suitable seals, fasteners, vents, vent caps and connectors may be used. [0090] Furthermore, any number of pressure relief valves could be used to allow the balloons to be inflated to a number of different pre-set pressure values. Each preset pressure value could be chosen by selectively closing the vents of the pressure relief valves by luer lock caps or some other form of sealing connector. [0091] Alternatively, a valve having a vent sealed with a plug but without a spring loaded seal may be included in the apparatus of the present invention. Removal of the plug from this type of valve will prevent the balloons from being inflated, and if the balloons are already inflated, will cause them to deflate. This type of valve will allow the balloons to be deflated in an emergency situation even if a syringe is not readily to hand. [0092] It is important to match the pressure controlled inflation system with a non-elastomeric, fixed volume balloons. Provided the volume of the balloons are bigger than the nasal chambers which are being treated then the pressure in the system is the same as the pressure applied to the nasal chambers. This is in contrast to using a balloon made from an elastomeric material where some of the pressure in the balloon is utilised in overcoming the forces within the balloon material itself. Consequently, with an elastomeric balloon there is no direct control of the actual force applied to the bleeding cavity. [0093] The devices incorporated in this invention are typically low pressure devices and will work at pressures up to approximately 25 KPa (Kilo pascals). A typical dual pressure device may have the high pressure set between 12 and 25 KPa and the low pressure set between 4 and 12 KPa. However, the principles of the invention should not be restricted to such low pressure devices.

1a

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] NOT APPLICABLE STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] NOT APPLICABLE REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK. [0003] NOT APPLICABLE [0004] This invention relates to automatic scrubbers commonly used for cleaning the large floor area of modem markets and stores. More particularly, a vacuum pre-sweeping system for an automatic floor scrubber is disclosed which can easily be attached to extant scrubbers and utilized for vacuuming and sweeping to eliminate dry mopping in advance of scrubbing. A suspension system is disclosed which allows for up-and-down excursion of the vacuum sweeper system as well as movement of the system to an upward position when vacuuming and sweeping is not required. BACKGROUND OF THE INVENTION [0005] Modern supermarkets and stores contain large polished opened flooring in ranges from 40,000 square feet to 120,000 square feet and above. Typically, these floors are tile covered and polished or burnished with a finish that shines and gives the store a safe, clean appearance. [0006] To maintain such floors, a four-step process is required by the prior art. First, the floor is typically dry dust mopped to clear the floor of large debris and dust. Second, the floor is scrubbed, usually with an automatic scrubber. The automatic scrubber dispenses detergent onto the floor, scrubs, and thereafter squeegees and vacuums the detergent from the floor. After the scrubbing step, the floor is polished or burnished with a buffer. Finally, after the polishing or burnishing, the floor is again dust mopped to pick up fine debris left in the wake of the polishing or burnishing operation. [0007] Each of these discrete steps consumes time and labor. For example, utilizing machinery having a 27-inch-wide path, dry mopping can consume five minutes per thousand square feet of floor per employee. Likewise, scrubbing can consume seven minutes per thousand square feet of floor per employee. Similarly, polishing or burnishing can consume seven minutes per thousand square feet of floor per employee. Finally, the final mopping after burnishing or polishing can consume five minutes per thousand square feet per employee. Thus, 1000 square feet of floor can require up to 24 minutes per thousand square feet of employee time during regular scrubbing and polishing cycles. [0008] It is to be noted that the above description of labor does not include so-called “double scrub” and “strip” cycles. In these latter cycles, the scrubber first dispenses detergent, scrubs with the detergent, and then leaves the detergent to dwell on the floor for a specific period of time. Thereafter, scrubbing is repeated with the detergent being gathered and recovered by the scrubber. Between the respective scrubbings, dry mopping is not utilized. [0009] In Fields U.S. Pat. No. 5,388,305 issued Feb. 14, 1995, I have combined the polishing and burnishing cycle with the second dry mopping cycle. Simply stated, I disclose a polishing and vacuuming apparatus having a revolving head surrounded by a skirt which biases to and towards the floor. The skirt is provided with a series of serrated slits angularly inclined with respect to the rotating polishing and burnishing brush. The slits draw air from the exterior of the burnishing apparatus through the skirt into the interior of the burnishing apparatus at the skirt. Thereafter, by providing the combination of a deflector and a vacuum apparatus, I gather to a micro filter vacuum bag the dust and debris generated by the polishing and burnishing operation. This improvement to the polishing and burnishing operation has experienced commercial success and eliminated approximately five minutes of labor per thousand square feet of floor maintained assuming 27-inch- wide polishing equipment is used. [0010] To date, there has been no equivalent improvement to the wet scrubbing operation. [0011] Automated floor sweepers are known. In one such sweeper, counter-rotating conical brushes are used on the sweeper ends. These brushes each rotate about vertical axes at opposite sides of the sweeper. Sweeping of the counter-rotating brushes occurs at a central ramp which typically is maintained a small constant distance above the floor. In some cases, a large cylindrical brush rotating about a horizontal axis in front of the debris ramp cooperates with the counter-rotating conical brushes to sweep large debris up the ramp and into a collector. No vacuuming provision is made for the collection of dust. [0012] Unfortunately, it is my experience that such sweepers are inadequate when utilized immediately before a scrubbing operation. Specifically, they are successful in collecting the large debris only and constitute a separate operation adding additional labor. They also lack the ability to collect fine particles and dust. Uncollected fine particles and dust give a “mud like” appearance to the floor in the wake of the wet scrubbing apparatus and constitute a serious degradation to the floor maintenance cycle. As a consequence, conventional dry mopping is almost always used before a floor scrubbing operation. [0013] There have been attempts to combine the dry mopping, scrubbing, and polishing and burnishing operation. Machines making such combinations have at least three problems. First, where the machines are battery operated, conventional battery operation has difficulty in simultaneously powering the sweeping, scrubbing, and polishing apparatus. In order to enable these three steps to be simultaneously powered from the same battery pack, machines of reduced width are required. As of this disclosure, combined sweeping, scrubbing, and polishing and/or burnishing machines have a width which does not exceed 20 inches due to the energy required to run sweeping, scrubbing, and polishing and/or burnishing operations simultaneously. [0014] Second, such machines are long with all three components in a straight line, one after the other. They do not operate efficiently on sharp turns such as those required to pass around the counter ends between aisles. A separate maneuver is required to align such machines for each pass down the floor aisles between the counters. Wasted time and energy results. [0015] Third, polishing and burnishing directly after scrubbing requires additional time. Since such machines are series machines, they can proceed at a speed no greater than the efficiency of the slowest component. In this case, it is the slow polishing cycle immediately after wet scrubbing the floor. For example, and utilizing a 20-inch machine, polishing and burnishing immediately after scrubbing results in the polishing and burnishing operation occurring on a semi dry surface. This semi dry surface can require up to 15 minutes per thousand square feet per employee with such a machine. The efficiency originally sought in the combined pre-sweeping, scrubbing and polishing and/or burnishing is not realized. BRIEF SUMMARY OF THE INVENTION [0016] A vacuum sweeper is cantilevered to a hinged bracket mounted to the front of a conventional automatic floor scrubber. The sweeper includes a central vacuum head, an overlying central debris ramp, and two vertically rotating, conical brushes having their base ends in contact with the floor. The base end of the conical brushes sweep a path at the edge of the vacuum sweeper in excess of the width of the scrubber. This enables sweeping to the edges of floor-standing counters at their inset kick plates. The base end of each of the conical brushes rotates large debris to and toward the ramp overlying the vacuum entrance to sweep the large debris up the ramp and into a following drawer mounted hopper. The base end of each of the conical brushes rotates small debris, such as dust, into the vacuum head on the underside of the ramp. The vacuum head is mounted between the counter-rotating conical brushes and defines a small gap over the floor being swept and vacuumed on the order of ⅜ of an inch. The rear and sides of the vacuum head are enclosed by substantially airtight bristle walls which slide over the floor surface behind the gap. Immediately adjacent to the gap, paired rollers support the forward lip to maintain the small gap at the leading edge of the vacuum head. When a vacuum is pulled upon the vacuum head, the energy of the vacuum is confined to and concentrated at the gap at the leading edge of the vacuum head. This produces a concentration of vacuum energy at the gap for the removal of small debris, such as dust. The entire vacuum sweeper apparatus is mounted for vertical excursion relative to the cantilevered mount to the hinge bracket to enable up and down excursion of the sweeper and vacuum responsive to either scrubber motion or inevitable floor irregularities encountered during floor scrubbing. Where vacuuming is not required in advance of scrubbing, such as during double scrubbing or floor stripping cycles, provision is made to hinge the vacuum sweeper upwardly away from floor engagement. [0017] As can be seen, I disclose a vacuum sweeper process and apparatus for use immediately before scrubbing. By combining vacuum sweeping with the scrubbing apparatus and process, I effectively eliminate the dust mopping step prior to scrubbing to achieve a superior time-saving result by combining the vacuum pre-sweeping with the scrubbing. Additionally, by isolating vacuum sweeping and scrubbing to one apparatus, and maintaining polishing and burnishing with fine particle vacuum gathering to a second apparatus, I affect an overall 40 percent saving in the conventional four step floor maintenance cycle. Each apparatus processes approximately 1000 square feet of floor area every seven minutes utilizing an apparatus having a 27 inch width. Thus, utilizing the floor cleaning apparatus of my Fields U.S. Pat. No. 5,388,305 issued Feb. 14, 1995 and the disclosed apparatus herein, I can reduce what was a 24 minutes cycle per thousand square feet per employee to a 14 minutes cycle per thousand square feet per employee for an overall labor saving in the order of 40 percent. BRIEF DESCRIPTION OF THE DRAWINGS [0018] [0018]FIG. 1 is a side elevation view of a conventional floor scrubber having the vacuum sweeper of this disclosure mounted and hinged at the forward end of the scrubber for sweeping and vacuuming the floor in the path of the scrubber; [0019] [0019]FIG. 2 is a top plan view of the vacuum sweeper illustrating the counter-rotating conical brushes at either side of the central vacuum head, the central vacuum head, the overlying large debris ramp, and the attached vacuum apparatus for receiving fine debris from the vacuum; [0020] [0020]FIG. 3 is a bottom plan view of the vacuum sweeper illustrating the conical base of the counter-rotating brushes, the bottom of this central vacuum head, the wheels for supporting the leading edge of the central vacuum head overlying the floor to define a measured gap with respect to the floor for concentrating vacuum intake through the gap, and the peripheral surrounding bristle wall for forming the support point of the central vacuum head relative to the floor; and, [0021] [0021]FIG. 4 is a schematic side elevation section taken along lines 4 - 4 of FIG. 3 illustrating gathering of large debris to the overlying debris ramp and vacuuming of small debris to the central vacuum head. DETAILED DESCRIPTION OF THE INVENTION [0022] Referring to FIG. 1, automatic scrubber 1 is shown having vacuum sweeper 2 mounted at the forward end of scrubber 1 . The normal direction of scrubber movement proceeds from the left of FIG. 1 to the right of FIG. 1 so that vacuum sweeper 2 sweeps the floor in advance of scrubber 1 . [0023] Automatic scrubber 1 is typical of scrubbers common to the marketplace. It includes a foreword rotating scrubbing brush 11 which is suspended from the main scrubber body. A medial propelling wheel 12 drives and supports automatic scrubber 1 as it is propelled along the floor. Rear supporting casters 14 in effect pivot automatic scrubber 1 about the medial propelling wheel 12 . Finally, there is a detergent removing squeegee 15 suspended at the rear of the scrubber 1 . Automatic scrubber 1 dispenses detergent, scrubs the floor utilizing the detergent, and recovers the used detergent by squeeging and vacuuming the detergent from the floor. [0024] It will be understood that scrubbing brush 11 must be shielded. Specifically, if left unobstructed as viewed in FIG. 1, considerable splatter of dispensed detergent would occur from the floor scrubbing operation. It is common to provide a shielding skirt around the periphery of the scrubber—especially in the vicinity of scrubbing brush(s) 11 to prevent such splatter. Further, such a skirt is virtually required between the pre-sweeping vacuuming attachment here disclosed and the scrubbing brush 11 . As all such automatic scrubbers are supplied with these skirts, they will not be shown here in the interests of letting the reader understand the suspension and operation of the automatic scrubber here disclosed. [0025] In the case of the vacuum sweeper 2 , I prefer to place a squeegee 15 a between vacuum sweeper 2 and scrubber 1 . This assures that vacuum sweeping occurs in a dry environment. [0026] Ignoring for the moment the operation of vacuum sweeper 2 , the conventional operation of automatic scrubber 1 is easy to understand. Automatic scrubber 1 is propelled from left to right in FIG. 1. Detergent tank 16 supplies detergent at rotating scrubbing brush 11 . Scrubbing brush effects scrubbing of the floor. The scrubber is propelled so that detergent removing squeegee 15 squeegees and vacuums detergent and scrubbed debris to detergent recovery tank 17 . Automatic scrubber 1 here shown is operated by an operator from operator station 18 , who walks behind the scrubber and guides it. [0027] Automatic scrubber 1 will be understood to be exemplary of commercial scrubbers that are now extant. From the description given thus far, two important points can be made about automatic scrubber 1 and the mounting of vacuum sweeper 2 at the forward end of the scrubber. First, the scrubber will inevitably pass over floor irregularities. Such irregularities will cause the front portion of the scrubber 1 , especially at a mounted vacuum sweeper 2 to move up and down. Second, automatic scrubber 1 will tend to pivot on medial propelling wheel 12 . In such pivoting, vacuum sweeper 2 will again tend to move up and down. As will be hereinafter set forth, vacuum sweeper 2 is mounted to the front of automatic scrubber 1 so that such up-and-down movement can be accommodated without lifting the vacuum sweeper 2 from the floor. Preferably, vacuum sweeper 2 is biased to and towards the floor to maintain a firm sweeping and vacuuming contact with the floor. [0028] Referring to FIG. 2, vacuum sweeper 2 is illustrated in plan. Here, vacuum sweeper 2 includes paired counter-rotating conical brushes 21 . The reader will of course understand that while two such brushes are preferred, only one conical brush 21 is required for the practice of this invention. [0029] Rotating conical brushes 21 have a vertical axis of brush rotation 22 . The brushes rotate from a shaft attached to the truncated apex of the conical brush 23 . The rotating conical brushes 21 extend downwardly to an expanded base of conical brush 24 which is in contact with the floor. Conical brushes 21 are mounted to vacuum sweeper body 25 . Brush motors 26 cause the conical brushes 21 to counter-rotate with respect to one another. In the view of FIG. 2, left brush 21 rotates counterclockwise while right brush 21 rotates clockwise. This rotation occurs while vacuum sweeper 2 attached to automatic scrubber 1 proceeds downwardly to and towards the floor to be swept and vacuumed as shown in FIG. 2. It will be noted that central vacuum head 4 is located between counter-rotating conical brushes 21 . The rotation of brushes 21 serves to sweep debris into this central vacuum head 4 for accumulation to collection container 29 by suction of vacuum apparatus 27 . [0030] Continuing with the view of FIG. 2, vacuum sweeper body 25 supports vacuum apparatus 27 . Vacuum collection container 29 contains a micro filter bag 28 for accumulating the debris fines in advance of the vacuum sweeper 2 . The micro filter bag 28 is confined within the vacuum collection container 29 . [0031] Referring to FIG. 2, vacuum sweeper mounting bracket 3 (See FIG. 1) is shown mounted to the front end of automatic scrubber 1 at sweeper mounting bracket 31 . Hinge 32 is placed between vacuum sweeper body 25 and bracket 31 . This enables vacuum sweeper 2 to either be placed in confrontation to the floor or to be moved to a pivoted position up and away from the floor, preferably at 90 degrees with respect to the position of the vacuum sweeper 2 illustrated in FIG. 1. [0032] Referring to FIG. 4, vacuum head 4 can be seen in detail. With respect to the floor, vacuum head 4 has a top central shell 44 covering the top of the vacuum head. This top central shell 44 is communicated at opening 45 to vacuum apparatus 27 . Thus, fine debris drawn centrally of central vacuum head 4 will end up in micro filter bag 28 of vacuum apparatus 27 . [0033] Support of central vacuum head 4 relative to the floor occurs at peripheral wall 41 . Preferably, peripheral wall 41 is made from a soft, pliable floor contacting material. Here, the soft floor contacting material constitutes a continuous U-shaped bristle brush which forms the peripheral wall. This bristle brush has a thickness and density so that a conformable, substantially airtight barrier is formed as the brush slides over the flooring. Peripheral wall 41 surrounds central vacuum head 4 along the rear and at the sides. The peripheral wall 41 terminates at gap 46 . Finally, floor contacting members 43 , here shown as wheels, suspend central vacuum head 4 at a constant elevation relative to the floor in the vicinity of gap 46 . This defines a constant spatial gap, the function of which can be understood with respect to FIG. 4. [0034] I provide a second gap 46 defined by vacuum head partition 47 . This divides vacuum head 4 into a rear suction chamber 43 which communicates directly to opening 45 to having micro filter bag 28 in vacuum apparatus 27 . The provision of second gap 46 assures concentration of the vacuum energy at the rear of vacuum head 4 to effect efficient removal of vacuumed fines with minimum supplied vacuum. [0035] Referring to FIG. 4, a section of vacuum head 4 taken along lines 4 - 4 of FIG. 3 is shown. Specifically, despite variations in the level of the floor, it will be seen that floor contacting members 43 support central vacuum head 4 with gap 46 supported at a constant distance from the floor surface. With this support, the suction of vacuum apparatus 27 is maximized in the gap 46 between the vacuum head 4 and the floor. This assures that debris fines will be gathered to the vacuum head 4 . As a practical matter I have found that any separation of vacuum head 4 from the floor surface destroys the effectiveness of the vacuuming that I desire. [0036] Referring further to FIG. 4, the function of large debris accumulator 5 can be understood. Large debris ramp 51 is shown immediately overlying vacuum head 4 . Large debris ramp 51 empties at the top to large debris bin 52 . Large debris bin 52 has a large debris bin opening 53 . The large debris bin 52 is drawer mounted to the underside or rear of vacuum sweeper body 25 . This arrangement enables the large debris bin to be selectively removed and emptied when filled. [0037] It is easy to understand filling of the large debris bin 52 with respect to FIG. 4. Specifically, rotating conical brushes 21 advance and rotate all debris, large and small, to and towards central vacuum head 4 and overlying large debris ramp 51 . Debris fines, which seriously interfere with the scrubbing process, are accumulated by the vacuum apparatus 27 to the micro filter bag 28 . At the same time, larger debris particles are swept up large debris ramp 51 into large debris bin 52 by the rotation of the rotating conical brushes 21 . Large debris particles such as wrappers, paper scraps, small sticks, and other debris are rapidly accumulated within large debris bin 52 . It will be noticed that at least some of the bristles protruding at the expanded base of conical brush 24 partially climb large debris ramp 51 assuring propulsion of the large debris particles up the ramp and into the waiting bin. Other brushes may be used for this require propulsion. [0038] Finally, with respect to FIG. 4, it will be remembered that automatic scrubber 1 in the vicinity of vacuum sweeper 2 undertakes considerable excursion with respect to the floor. This excursion arises because of variations in floor height as well as natural rocking of scrubber 1 . This being the case, vertical bias suspension 6 is provided between vacuum sweeper body 25 and vacuum sweeper head 4 . Specifically, a series of rods 61 gravitationally suspends vacuum sweeper head 4 with respect to vacuum sweeper mounting attached to vacuum sweeper body 25 . As either the floor height varies or automatic scrubber 1 rocks, vacuum sweeper head 4 will remain in the same firm contact with the floor. As a result, consistent sweeping and vacuuming will result. It is preferred to have coil springs 63 biasing vacuum sweeper body 25 to and toward the floor. [0039] The reader will understand that the above preferred embodiment can vary within wide limits. For example only one rotating conical brush 21 is required. Further, although a vertical axis of brush rotation is preferred, axes other than vertical may be used as well. For example, cylindrical brushes could be used as well. Further, while we show a conical brush, other brush shapes could be used as well. We illustrate a vacuum sweeper body 25 ; this body could take any form including joining some or all of the operative parts of vacuum sweeper 2 together. It will be understood that the vacuum sweeper mounting bracket 3 will change form to accommodate any portion of automatic scrubber 1 and any particular model of automatic scrubber 1 to which mounting is required. Further, while hinge 32 is preferred, it is not required. For example, the vacuum sweeper 2 could merely be elevated on rods 61 . [0040] I prefer a vacuum sweeper retainer 33 to retain vacuum sweeper 2 from the horizontal position where vacuuming and sweeping is not required, especially during certain portions of double scrubbing and the floor stripping. Sweeper retainer 33 can take many forms. Here it is illustrated as a strap. Alternately, a could either be a mechanical lever, cable, solenoid apparatus, electric actuator, or of many formats to move vacuum sweeper 2 relative to hinge 32 on vacuum sweeper mounting bracket 3 . [0041] Likewise it will be understood that central vacuum head 4 will admit of variation. While the construction utilizing the gap 46 , peripheral wall 41 , and floor contacting member 43 is preferred, other vacuum heads incorporated with rotating conical brushes 21 will suffice. For example, where high horsepower vacuuming devices are used, the care taken with respect to gap 46 can be compromised. Further, while I illustrate floor contacting members in the form of wheels, slides, guides, pads, and others supporting members could as well be used. [0042] It will be understood that the large debris accumulator 5 is not a requirement of this invention. I concentrate on collecting the fine debris in order to prevent the phenomenon of “mud” in the wake of scrubber 1 . It will be understood that the entire scrubbing process could proceed without the specific collection of large debris by the vacuum sweeper 2 . [0043] Other variations can occur to accommodate specific circumstance.

1a

FIELD OF THE INVENTION The present invention generally relates to a method and apparatus for reducing the fracture of a bone and particularly to a method and apparatus for holding a guide rod in place in a medullary canal of a bone during reduction of a fracture in that bone. BACKGROUND OF THE INVENTION Prior to setting a bone fracture, the fracture must be reduced. That is, the various bone fragments or pieces must be repositioned in their proper relative arrangement before the fractured bone can be fixed or stabilized for healing. Various techniques exist for reducing bone fractures, one of which is disclosed in U.S. Pat. No. 5,122,146. In that patent, the fracture is reduced using, in part, a fracture reduction tool and a "guide wire". Through manipulation of the fracture reduction tool (and the help of an assistant if necessary), proper alignment of the fragments is achieved. The proper alignment is then maintained by the insertion of the guide wire through the medullary canal of each fragment. Further reduction and preparation for stabilization is performed by reaming the medullary canal of the fragments that are now held in alignment. This operation is achieved by sequentially advancing and retracting a series of hollow reaming instruments over the guide rod. With the use of each successive reaming instrument, the medullary canal is increased in size until it is enlarged sufficiently to receive a nail or pin that will permanently keep the bone fragments in proper alignment and thereby stabilize the bone for healing. Although not mentioned in U.S. Pat. No. 5,122,146, in practice, the use of a guide wire in the reduction of fractures can prove highly disruptive. Most frequently this occurs during the reaming operation where the reaming instruments are being advanced and retracted over the guide wire. Since the guide wire is not secured in position within the medullary canal during the reaming operation, retraction of the hollow reaming instrument, through contact with the guide wire, often pulls the guide wire out of position, even when the surgeon is using extreme caution. When this occurs, the entire reduction procedure must be started again thus obviously leading to greater risk of damaging the fractured area as well as increasing the time required to complete the procedure. No guide wires of the known prior art have provided any acceptable solution to this problem. The guide wire of U.S. Pat. No. 5,122,146 includes a bead-tip at its distal end, however the function of the bead-tip is primarily to prevent the reaming instrument from being advanced too far within the medullary canal; it does not secure the guide wire within the canal. SUMMARY OF THE INVENTION It is therefore the goal of the present invention to overcome the problems associated with the use of a guide wire, guide rod or the like in the procedure of reducing fractures. Particularly, it is the goal of the present invention to provide a method and apparatus capable of ensuring that a guide wire (or guide rod or the like) is secured in a desired position in the medullary canal of the fractured bone throughout the reduction procedure. The various novel features of the invention which are believed to achieve these goals as well as to provide other advantages and improvements will be understood from the following specification and accompanying drawings in which a preferred embodiment of the invention is illustrated by way of example. It is expressly understood, however, that the specification and drawings are for purposes of description and illustration only and are not intended as a definition of the limits of the invention as set forth in the claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a guide rod in accordance with an embodiment of the present invention; FIGS. 2A-2B illustrate a second embodiment of a guide rod in accordance with the present invention; FIGS. 3A-3B illustrate a third embodiment of a guide rod in accordance with the present invention; FIGS. 4A-4B illustrate a fourth embodiment of a guide rod in accordance with the present invention; FIGS. 5A-5B illustrate a fifth embodiment of a guide rod in accordance with the present invention; FIGS. 6A-6C illustrate a sixth embodiment of a guide rod in accordance with the present invention; FIGS. 7A-7B illustrate a seventh embodiment of a guide rod in accordance with the present invention; FIG. 8 illustrates the positioning of a guide rod in accordance with an embodiment of the present invention within the medullary canal of a fractured femur; FIG. 9 illustrates the secured position of a guide rod in accordance with an embodiment of the present invention within the medullary canal of a fractured femur; FIG. 10 illustrates the advancement of a reaming instrument guided by a guide rod in accordance with an embodiment of the present invention; FIG. 11 illustrates the secured position of a guide rod in accordance with an embodiment of the present invention after retraction of the reaming instrument of FIG. 4; FIG. 12 illustrates the insertion of a permanent nail over a guide rod in accordance with an embodiment of the present invention and the configuration of the guide rod just prior to removal of the guide rod from the medullary canal of a fractured femur. DETAILED DESCRIPTION A guide rod 100 in accordance with the present invention is depicted in FIG. 1 and includes an elongated rod section 101 which is substantially circular in cross-section. The rod section 101 may be made of a flexible material so that the guide rod 100 may be used in reducing fractures that are either substantially straight or that have a degree of curvature. Provided at regular intervals along the length of the elongated rod section are radiopaque measuring markers 105 that are useful for monitoring the location of the rod within the medullary canal. Finally, the distal end 113 of the elongated rod section 101 is formed to have a bullet shape. This shape provides advantages over other shapes such as beaded ends or blunt shapes as it facilitates advancement of the guide rod 100 through the material within the medullary canal of the bone. At the proximal end of the guide rod 100 is a handle arrangement 102 that is gripped by the user and used to facilitate insertion of the guide rod into the medullary canal of a bone. Once the guide rod 100 is in place, the handle arrangement may be removed in order to allow further steps in the fracture reducing procedure. At the distal end of the guide rod 100 is a guide rod retention device 103 for retaining the guide rod 100 in place once it has been moved into a desired position within the medullary canal of the bone. The retention device includes a plurality of finger members 104 that are selectively actuatable between a first position where each finger member 104 rests substantially within the cross-sectional profile of the guide rod 100 (not shown) and a second position where each finger member 104 extends flares outwardly from the cross-sectional profile of the guide rod 100. When in the second position, the finger members 104 come into contact with material within the bone and thereby anchor the guide rod in the desired position within the medullary canal. It will be appreciated that any number of mechanisms may be incorporated into the guide rod 100 to provide the actuating function for the finger members 104. In one embodiment, that mechanism may include a screw-type device similar to that used in a rotary actuated ballpoint pen. By turning the handle assembly 102, the finger members 104 emerge from the distal end and spread outwardly to contact material within the bone. Other contemplated embodiments might use a tension notch device similar to that of a floor jack or a pressurized trigger device similar to that used to actuate a balloon-tip catheter. Instead of being actuated through the distal end of the guide rod 100 as depicted in FIG. 1, it is contemplated the finger members 104 may be actuated outwardly from the cross-sectional profile of the guide rod 100 as depicted in FIGS. 2-7. Finger members 104 actuated in this manner may initially rest completely within the cross-sectional profile or may rest adjacent to the cross-sectional profile. A number of different ways may be implemented to actuate the finger members 104 in this manner. Referring to FIGS. 2A and 2B, the finger members 104 extend between the distal end 113 of the guide rod 101 and a threaded nut member 201 that is mounted on corresponding threads 200 on the guide rod. By rotating the nut member 201 through the handle assembly 102, the finger members 104 begin bulging outwardly from the cross-sectional profile of the guide rod 100 as seen in FIG. 2B so as to come into contact with material within the bone. Referring to FIGS. 3A and 3B, the finger members 104 extend between the distal end 113 of the guide rod 100 and a sealing ring 301 such as an O-ring that is mounted on an actuating shaft 300 that extends through the guide rod 100 and is attached to the distal end 113. By urging the actuating shaft 300 upwardly through the guide rod 100, the finger members 104 begin bulging outwardly from the cross-sectional profile of the guide rod 100 as seen in FIG. 3B so as to come into contact with material within the bone. It is contemplated that the shaft 300 could be locked in place using a locking mechanism similar to that used in a push-button ballpoint pen or to that used in an umbrella. Referring to FIGS. 4A and 4B, the finger members 104 extend between the distal end 113 of the guide rod 100 and a ring 402 that is slidably mounted on the guide rod 100. Mounted on the guide rod 100 between the ring 402 and the distal end 113 is a bladder 400 that is inflatable through air holes 401 located in the guide rod 100. Upon inflation of the bladder 400, the finger members 104 begin bulging outwardly from the cross-sectional profile of the guide rod 100 as seen in FIG. 4B so as to come into contact with the material within the bone. Referring to FIGS. 5A and 5B, the finger members 104 extend between the distal end 113 of the guide rod and the end elongated shaft 101 of the guide rod 100. An actuating wire 500 extends through the shaft 101 and is connected to the distal end 113 of the guide rod 100. By urging the wire 500 upwardly through the guide rod 100, the finger members 104 begin bulging outwardly from the cross-sectional profile of the guide rod 100 as seen in FIG. 5B so as to come into contact with the material within the bone. Referring to FIGS. 6A and 6B, a finger member 104 is pivotally attached to the distal end 113 of the guide rod 100. A threaded nut 601 is mounted on the guide rod 100 through corresponding threads 600 on the guide rod 100. As the nut 601 is threaded downwardly towards the distal end of the guide rod 100, the body of the nut 601 forces the finger member 104 to pivot such that a pointed end of the finger member 104 is urged outwardly from the cross-sectional profile of the guide rod 100 as seen in FIG. 6B so as to come into contact with the material within the bone. Of course, a plurality of finger members 104 may be utilized as depicted in FIG. 6C. Referring to FIGS. 7A and 7B, the finger members 104 extend between the distal end 113 of the guide rod 100 and the end of the elongated rod 101 of the guide rod 100. The inside of the elongated rod 101 serves as a hydraulic cylinder housing 701 for a hydraulic piston arrangement 700 that is connected to the distal end 113 of the guide rod 100. By introducing and withdrawing fluid into and out of the cylinder housing 701, the finger members 104 are actuated. When fluid is withdrawn, the distal end 113 of the guide rod 100 is urged upwardly and the finger members 104 are urged outwardly from the cross-sectional profile of the guide rod 100 as seen in FIG. 7B so as to come into contact with the material within the bone. Referring now to FIGS. 8-12, the use of the guide rod 100 in the reduction of a fractured femur is described. Initially, of course, the patient has been anesthetized and an incision has been made to allow insertion of various tools into the fractured area. As shown in FIG. 8, the guide rod 100 is introduced into the medullary canal 106 of the fractured bone and advanced towards the joint 107 of the bone. During this insertion and advancement step of the reduction procedure, the finger members 104 of the retention mechanism 103 are kept within the circular cross-sectional profile of the guide rod 100, that is, the retention mechanism 103 is unactuated. Once the guide rod 100 is located in the desired position, the retention mechanism 103 is actuated by turning the handle assembly 102. This leads to the flaring finger members 104, extending outwardly from the cross-sectional profile of the guide rod section 101 and contacting material within the joint area 107 of the fractured bone and thereby anchoring the guide rod 100 into place as shown in FIG. 9. The guide rod 100 thus being anchored into place, the surgeon may then begin the reaming stage of the procedure to prepare the medullary canal 106 for receiving a permanent nail or rod 109 that will stabilize the fracture for healing. The finger members 104 are locked into place and the handle arrangement 102 is then removed. A series of hollow reaming instruments 108 are then sequentially advanced and retracted along the guide rod 100, the guide rod 100 having a diameter that is insertable into the hollow of each reaming instrument 108. FIG. 10 illustrates the reaming operation. Typically, there is little clearance between the guide rod 100 and the hollow of the reaming instrument 108, hence, advancement and retraction of the reaming instrument will often exert a force on the guide rod 100 due to contact of the inside surface of the hollow reaming rod 108 with the guide rod 100. However, since the finger members 104 of the retention mechanism 103 have anchored the guide rod 100 into place, such contact can be overcome without adversely effecting the guide rod's placement; the guide rod will remain in its desired location throughout the reaming operation as seen in FIG. 11. Once reaming has been completed, the medullary canal 106 is ready to receive the permanent nail 109 that will stabilize the fracture as depicted in FIG. 12. As with the reaming instruments, the nail 109 is hollow and therefore able to be guided into place by advancement over the guide rod 100 with a known mallet and nail alignment assembly 110. During insertion, the guide rod is prevented from any movement urged by contact between the nail 109 and the guide rod 100 because the guide rod is anchored into place by the finger members 104 of the retention mechanism. Once the nail 109 has been advanced to its desired final position, the mallet and nail alignment assembly 110 is removed and the handle assembly 102 is remounted onto the guide rod 100. The retention mechanism 103 is unlocked and deactuated thus causing the flaring finger members 104 to return to their original position within the elongated rod section 101, out of contact with the material within the bone as depicted in FIG. 12. This, of course, also releases the guide rod 100 from its anchored position within the medullary canal 106. The guide rod is then removed from the medullary canal 106 leaving the nail 109 in place. Finally, the nail is secured to the bone with a known drilling and nailing procedure. While the invention has been described with reference to a particular embodiment, it is understood that the embodiment is merely illustrative as there are numerous variations and modifications which may be made to those skilled in the art. Thus, the invention is to be construed as being limited only by the spirit and scope of the appended claims.

1a

BACKGROUND OF THE INVENTION The present invention relates to the manufacture of laminated products having many layers, and, more particularly, to the manufacture of laminated food products, such as candy, which are formed by the layering of a smooth nonabsorbent material and a soft flowable material. For many years, candy bars have been manufactured which have a crisp texture together with a strong flavor component associated with a soft material. This combination of texture and taste has been achieved by producing a laminate which contains many thin layers of a brittle candy separated by thin layers of the soft flavor material. These candy bars are conventionally made by a labor intensive process that produces inconsistent results. In the prior art process, a hot solution of corn syrup and sugar is dropped on a circular chilled table. A pair of scrapers work the solution by drawing it from opposite outer edges of the table toward the center, the table turning about 1/8 turn between successive scraper operations. As the solution cools, it turns into a soft pliable taffy. Color and flavor ingredients, in liquid form, may be added to the taffy by pouring it into a depression formed in the taffy mass. The taffy mass is manually folded to cover and close the depression. The mass is then manually lifted onto the hooks of a taffy puller. The puller works the taffy, aerating it to reduce its density. The aerated taffy is transferred from the puller to a conveyor and is fed between rollers to a form sheet. A layer, for example, of hot peanut butter is applied to the sheet and the sheet is severed at predetermined intervals. Each section of sheet is rolled into a log weighing about 80 lbs. The log is folded in half, fed between rollers and rolled out into a sheet once more. This sheet is again rolled into a log which is manually wrapped in a sheet of taffy to keep peanut butter from squeezing out the ends and to provide and insure that the product pieces have an outer sheet of candy with no exposed peanut butter. The log is manually placed in one of a number of spinning machines that feed a conveyor. The spinning machines have several long rotating cones provided with traction knobs and are positioned on axes that converge toward the output end. The cones are spaced to receive the log and are rotated to draw the log toward the output end and thus stretch the log into a rope about 1/5 its original diameter (from about 5 inches diameter to about 1 inch diameter). The ends of the rope are manually fed onto a conveyor which carries a number of ropes each formed by a separate spinner. The ropes are divided into product sized bars and enrobed with chocolate. The sheet of taffy in which the log is wrapped forms a taffy wall at each end of the log. As these end portions are stretched out to form the rope, they produce rope sections containing unlaminated taffy. This results in undesirable hard spots in the candy bars. SUMMARY OF THE INVENTION An object of the present invention is to provide a method and apparatus for continuously producing uniform products that are composed of alternate layers of different materials. It is a further object to provide a method and apparatus which has particular application in the manufacture of laminated candy products made of alternating layers of hard and soft materials. It is still a further object to provide a method and apparatus which eliminates the disadvantages of known methods of making laminated candy products. These and other objects of the present invention are achieved by a method for producing a laminated sheet product comprising the steps of continuously forming a semifluid sheet of a first material on a moving conveyor, continuously depositing a second material onto the sheet of first material to form a layered sheet of the first and second materials, continuously rolling the layered sheet from the edges thereof inwardly to form a double roll extending longitudinally along the conveyor and flattening the roll to form a laminated sheet. In order to produce individual commercial product sized pieces, the laminated sheet is then divided into longitudinally extending strips and the strips are then cut transversely into individual pieces. In accordance with the above described method, the objects of the invention are achieved by an apparatus for producing a laminated sheet product having alternating thin layers of a semifluid first material and a semifluid second material comprising longitudinally extending conveyor means, means for continuously forming a semifluid sheet of the first material on the conveyor means, means for continuously depositing the second material on the sheet to form a layered sheet of first and second materials, means for continuously rolling the sheet from the edges thereof inwardly to form a double roll extending longitudinally along the conveyor means and means for flattening the roll into a laminated sheet product. Other objects, features and advantages of the present invention will be apparent from a reading of the detailed description which follows. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention have been chosen for purposes of illustration and description, and are shown in the accompanying drawings forming a part of the specification, wherein: FIGS. 1A to 1E provide a top plan view of apparatus according to the present invention when laid out end to end in sequential order; FIGS. 2A to 2E provide a front elevational view of the apparatus shown in FIGS. 1A to 1E when laid out end to end in sequential order; FIGS. 3A to 3E provide a top plan view of a second embodiment of apparatus according to the present invention when laid out end to end; FIGS. 4A to 4E provide a front elevational view of the apparatus shown in FIGS. 3A to 3E when laid out end to end; FIG. 5 is a sectional view of the product on the conveyor taken along line 5--5 of FIG. 1A; FIG. 6 is a sectional view of the product taken along line 6--6 of FIG. 1C; FIG. 7 is a sectional view of the product taken along line 7--7 of FIG. 1C; FIG. 8 is a sectional view of the product taken along line 8--8 of FIG. 1C; FIG. 9 is a sectional view of the product taken along line 9--9 of FIG. 1C; FIG. 10 is a sectional view of the product taken along line 10--10 of FIG. 3A; FIG. 11 is a sectional view of the product taken along line 11--11 of FIG. 3A; FIG. 12 is a sectional view of the product taken along line 12--12 of FIG. 3A; FIG. 13 is a sectional view of the product taken along line 13--13 of FIG. 3C; FIG. 14 is a sectional view of the product taken along line 14--14 of FIG. 3D; FIG. 15 is a sectional view of the product taken along line 15--15 of FIG. 3D; FIG. 16 is a top plan view of a modification usable in place of a laterally oscillating chute or conveyor; and FIG. 17 is a front elevational view of the apparatus of FIG. 16. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, there is shown in FIGS. 1A-1E and 2A-2E one embodiment of apparatus according to the present invention in which a cooking and aerating unit 10 continuously produces a stream of a hot aerated solution of corn syrup and sugar, discharging the stream through a nozzle 11 onto a steel band conveyor 12. The unit 10 may be one of the type manufactured by the Otto Hansel company of Germany and sold under the trade name SUCROLINER. The solution exiting from the nozzle 11 is at about 258° F. and is in a very liquid state. A water cooling unit 14 is provided below the upper run of the conveyor 12 to cool the solution to a working temperature between 160° F. and 200° F., at which temperature the solution is in a plastic state. The cooling unit 14 sprays water on the bottom surface of the upper run of the conveyor band. The temperature of the spray water varies from about 160° F. near the input end of the conveyor 12 where the solution is hottest to about 120° F. near its output end. The stream of solution discharged from the nozzle 11 is immediately spread across the conveyor 12 by a spreader 15 to form a sheet of candy. Ground candy scrap, commonly referred to as "rework", is sprinkled onto the sheet from a vibratory feeder 16 and melts into the hot sheet. A pair of plow blocks 17 (which are suspended from an overhead framework not shown) engage the edges of the candy sheet and fold the edges over onto the center as shown in cross section in FIG. 5. The plow blocks 17 may be rectangular blocks of plastic or metal which are formed with a concave surface 19 for engaging and folding over the candy sheet. The folded sheet exiting from the first set of plow blocks 17 is rolled down and stretched by a cleated roller 20. The sheet exiting from the roller 20 is again folded by a pair of plow blocks 21 and then rolled and stretched by a second cleated roller 22. The narrow thick sheet or rope of candy leaving the roller 22 is then turned over twice, as shown in FIGS. 1B and 2B, by single plows 24 and 25 spaced further along the conveyor 12. The folding and turning of the candy sheet by the plow blocks 17, 21, 24 and 25 allows the candy to cool evenly and prevents excessive cooling of one surface which would result in hardening or "skinning over" of the surface. Referring now to FIGS. 1C and 2C, at the end of conveyor 12, the rope of candy is transferred onto an oscillating chute 26, and from that chute onto a second conveyor 27 which is traveling at a slower rate than the conveyor 12. The chute 26 oscillates about a vertical axis centrally placed at the input end of the chute. The chute 26 narrows toward its output end and is provided with side walls 29 to direct the flow of the candy rope. The chute 26 is mounted on a vertical shaft 30 which is oscillated about its axis by a motor 31 through a crank 32 on the shaft of the motor, an arm 34 on the shaft 30 and a link 35 interconnecting the crank 32 and the arm 34. The oscillating motion of the chute 26 causes the candy rope to be laid down in a sinuous pattern on the slower moving conveyor 27. A pair of guide plates 36 (supported by an overhead framework not shown) confine the folds of the candy rope allowing them to build up in front of a smooth sheeting roll 37. The sheeting roll 37, operating against a backing roll 39 beneath the conveyor belt, rolls the accumulated candy mass into a thin candy sheet. This sheet is operated upon by a scoring roll 40 which is formed with two sets of helical ridges (a lefthand set and a right hand set) extending outwardly from the center of the roll. The roll 40 turns at the same speed that the candy sheet is moving and impresses into the candy sheet a "herring-bone" pattern comprising a series of "V" shaped grooves 41 pointing in the direction the sheet is traveling, as shown in FIG. 1C. Immediately after the roll 40, hot liquefied peanut butter, for example, may be dispensed onto the candy sheet. The peanut butter is pumped from a unit 42 to a pipe 44 that extends across the conveyor 27 and is provided with a number of dispensing nozzles spaced across the candy sheet. The peanut butter is spread with a spreader 45 across the candy sheet and into the grooves 41, as shown in cross section in FIG. 6. The sheet is then rolled from each edge toward the center of the sheet by a pair of sidewinder units 46, each of which contain a serrated roller 47. The units 46 are positioned at each side of the conveyor 27 and the rollers 47 extend over the conveyor at an inward angle from the direction of conveyor travel. The rollers 47 engage and lift the edges of the candy sheet and roll them toward the center to form a double jelly roll configuration as is shown in cross section in FIG. 7. The grooves 41, because of their orientation, aid in the rolling process. They also act as receptacles to hold the peanut butter within the double roll configuration and thus prevent the peanut butter from squeezing out as the roll is formed. The double rolled sheet is rolled down by a cleated roller 49 to form a laminated thick sheet as shown in cross section in FIG. 8. This sheet is folded in half by a plow block 50 to form a laminated rope as shown in cross section in FIG. 9. This rope is rolled out into a relatively thick laminate by a cleated roller 51 as shown in FIGS. 1D and 2D. The thick sheet moves from the end of the conveyor 27 through a swing laminator 52 onto a conveyor 54. The laminator 52 includes a substantially vertical plate 55 positioned under the outlet end of the conveyor 27. The plate 55 is pivoted at its upper end about a horizontal shaft 56 and is oscillated by means not shown, to move in an arc as shown by the arrows and thereby repeatedly fold the candy sheet back on itself, placing one layer of laminate upon another. The number of these layers in the sheet produced by the laminator 52 is controlled by the rate of oscillation of the plate 55 and the speed of the conveyor 54 relative to that of the conveyor 27. However, typically three layers of laminate are combined in this manner so that the number of layers of peanut butter and candy are tripled. A pair of side wall guide plates 57 are provided to keep the layers in alignment, one with another. The laminated sheet is rolled down in three successive stages by cleated rollers 59, 60 and 61. The rolled out thin sheet is transferred to a conveyor 62 and is rolled out further by a sheeting roll 64. This thin sheet is then rolled inwardly from both edges by a second pair of sidewinders 65 to produce another double jelly roll configuration and once again multiply the number of layers of peanut butter and candy in the final product. Each time the number of layers are increased and the sheet is rolled out again, the individual layers become thinner, giving the product a more delicate nature. At the end of the conveyor 62, as shown in FIGS. 1E and 2E, the double rolled sheet is rolled down by a cleated roller 66 and the rolled down sheet is twisted 180 degrees and fed onto a conveyor 67 disposed beneath the conveyor 62. This twisting action can be accomplished by plow blocks, for example, similar to the plow blocks 24 and 25 shown in FIGS. 1B and 2B. The sheet is then rolled out in three successive stages by cleated rollers 69, 70 and 71. The reason for twisting the sheet is that at least part of the bottom surface of the candy may have been continuously against the conveyor and may not have been directly subjected to the stretching and working action of the cleated rollers. Therefore the bottom candy layer of the laminate is thicker and denser than the other layers are at the point of the 180 degree twist. The rollers 69, 70 and 71 stretch and thin this layer to make the laminate more uniform throughout its cross section. The laminate is then transferred to a conveyor 72 and is rolled to its final thickness by sheeting rolls 74 and 75. The sheet is longitudinally grooved by a pre-form roller 76 to facilitate cutting. The preformed sheet moves off the conveyor 72 and between a slitter roll 77 and a back up roll 79. The preformed sheet is longitudinally cut by the slitter roll 77 which has a plurality of thin cutting blades 80. To insure complete severing of the sheet, the back up roll 79 may be provided with slits to receive the tips of the cutting blades. The separated product strips are given their final cross-sectional shape by a shaping roll 81. The product strips may then be cut into product sized lengths and enrobed or encapsulated with chocolate. Referring now to FIGS. 3A-3E and 4A-4E, there is shown another embodiment of apparatus according to the present invention which includes the same cooking and aerating unit 10, steel band conveyor 12, water cooling unit 14, spreader 15 and vibratory rework feeder 16. In this embodiment, the peanut butter is preferably deposited on the candy sheet immediately after the rework is added by application pipe 82. The pipe 82 extends from a pressurized source of peanut butter across the conveyor 12. The pipe 82 is provided with a nozzle 84 positioned a short distance from one edge of the candy sheet, and a nozzle 85 positioned further toward the center of the sheet. The two nozzles deposit parallel spaced streams of peanut butter 86, 87 upon the sheet. A plow block 89 lifts the edge of the candy sheet and rolls it over the first peanut butter stream 86 as shown in cross section in FIG. 10. A second plow block 90 or an extension of the first lifts the enrobed stream 86 and rolls it over the second peanut butter stream 87 as shown in cross section in FIG. 11. A third plow block 91 on the opposite side of the conveyor lifts the other edge of the sheet and folds it over upon the two enrobed streams as shown in FIG. 12. The folded sheet is rolled down by a cleated roll 92 to seal the top two candy layers together and thereby encapsulate the peanut butter within a candy coating. The sealed rope of candy and peanut butter is turned over twice as shown in FIGS. 3B and 4B by single plows 24 and 25 spaced along the conveyor 12. The folding and turning of the candy allows the candy to cool evenly and prevents excessive cooling of one surface which would result in hardening or "skinning over" of the surface. After being rolled down and turned over twice, the product rope consists of two layers of peanut butter separated and surrounded by candy as shown in cross section in FIG. 13. In this embodiment the product rope is transferred from the oonveyor 12 to the conveyor 27 by a laterally pivoting conveyor 94. The conveyor 94 is supported at its input end by a yoke 95 having a shaft 96 that is journalled in a block 97 which is supported by suitable framework 99. The output end of the conveyor 94 is supported by a wheel 100 oriented transversely of the conveyor and riding on a track 101 which is suitably supported. The output end of the conveyor is oscillated transversly by a motor 102, a crank 104 mounted on the motor shaft, an arm 105 secured to the conveyor 94, and a link 106 connecting the crank 104 to the arm 105. The transverse oscillation of the conveyor 94 causes the layered rope to be laid down in a sinuous pattern on the slower moving conveyor 27 between the guide plates 36. The folds of the layered rope pile up against the smooth sheeting roll 37 and these folds are pressed together between the sheeting roll 37 and a back up roll 39 to produce a candy sheet having 2 to 4 times as many layers as the layered rope. The laminated sheet then flows directly to the two sidewinder units 46 where the sheet is rolled from each edge toward the center to produce the double jelly roll configuration and again multiply the number of laminations in the final product. Radiant heaters 47 may be employed as shown to insure that the sheet is sufficiently pliable. Referring now to FIGS. 3D and 4D, the double rolled sheet is rolled down by a cleated roll 49 and is folded over from each edge by plow blocks 107 and 109 to an on-edge configuration shown in cross section in FIG. 14. A third plow block 110 lays the folded sheet on its side and the sheet now has double the number of laminations as the sheet rolled out by the cleated roll 49. The sheet is then fed to another cleated roller 51. The wider rolled out sheet exiting from roller 51 flows into the laminator 52 where it is folded back on itself in a number of layers to further multiply the laminae in the product sheet, as explained above with respect to FIGS. 1D and 2D. In this embodiment, on-edge belt conveyors 111 and 112 are used as guides to keep the layers in alignment with one another. The laminated sheet is then rolled down in stages by the cleated rollers 59, 60 and 61, and is then transferred onto conveyor 72 where it is rolled out by a sheeting roll 114. A pair of side guides 115 extend from the roller 61 to the roll 114 to control the width of the sheet supplied to the roll 114. The roll 114 is provided with a pair of ridges 116 to insure that the sheet exiting from the roll 114 is of uniform width. The conveyor 72 is driven at a somewhat faster rate than the roller 61 to stretch out and thin the laminated candy sheet. At the end of the conveyor 72, as shown in FIGS. 3E and 4E, the laminated candy sheet moves under the preform roller 76 and between the slitter roll 77 having blades 80 and the slitted back up roll 79. The product strips exiting the slitter roll 77 are carried by a conveyor 117 under the shaping roll 81 and then transferred to a diverging conveyor 119 which may include, for example, a plurality of angled guide or guides of increasing width. The product strips leaving the diverging conveyor 119 are laterally spaced from each other and are transferred to a conveyor 125 where they are cut into product size lengths by a cutter, for example, a rotary cutter 126. The product pieces are spaced longitudinally by transferring them to a faster moving conveyor 127 for chocolate encapsulation. In FIGS. 16 and 17 there is disclosed an arrangement which could be used in place of the oscillating chute 26 of the first embodiment, shown in FIGS. 1C and 2C, or in place of the pivoted conveyor 94 of the second embodiment, shown in FIGS. 3C and 4C. In the arrangement of FIGS. 16 and 17, diverging vertical guide walls 129 are provided prior to the sheeting roll 37 and the speed of the conveyor 27 is adjusted with respect to that of conveyor 12 to create a piling up of candy mass in front of the sheeting roll 37, much as shown in FIGS. 1C and 3C. In the foregoing specification, the invention has been described with reference to specific exemplary embodiments thereof. It will, however, be evident that various modifications and changes may be made thereunto without departing from the broader spirit and scope of the invention as set forth in the appended claims. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.

1a

RELATED APPLICATIONS [0001] This application claims the benefit of the priority of Application No. 61/644,328, filed May 8, 2012, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The invention relates to a system, kit and method for reduction of fatty tissue in the body, and more particularly to removal of fatty tissue by lipolysis using near infrared laser light. BACKGROUND OF THE INVENTION [0003] Liposuction evolved from work in the late 1960 s from surgeons in Europe using primitive curettage techniques which were largely ignored, as they achieved irregular results with significant morbidity and bleeding. Modern liposuction first burst on the scene in a presentation by the French surgeon, Dr Yves-Gerard Illouz, in 1982. The “Illouz Method” featured a technique of suction-assisted lipolysis after tumesing or infusing fluid into tissues using blunt cannulas and high-vacuum suction and demonstrated both reproducible good results and low morbidity. During the 1980 s, many United States surgeons experimented with liposuction, developing variations, and achieving mixed results. Most commonly, liposuction is performed on the abdomen and thighs in women, and the abdomen and flanks in men. According to the American Society for Aesthetic Plastic Surgery, liposuction was the most common plastic surgery procedure performed in 2006 with 403,684 patients. [0004] Traditional liposuction relies on two techniques. The first technique employs a sharp, relatively large diameter (3 mm-5 mm) cannula that is manually manipulated to mechanically break fat down and while applying suction to remove the separated fat. A variation of this vacuum assisted technique is a mechanically powered cannula that reduces the surgeon's fatigue during large surface area liposuction procedures. [0005] The second technique utilizes ultrasonic waves via a vibrating cannula, this technique is mechanical in its nature and significantly reduces the surgeon's fatigue factor. This technique induces the same or worse mechanical trauma to the tissues. Both techniques require significant amounts of fluid, known as a “tumescent solution,” to be injected into the body to emulsify the fat, facilitating the removal of large volumes of fat while reducing blood loss and delivering a local anesthetic (lidocaine) to provide post-operative pain relief While generally safe, lidocaine can be toxic, leading to serious complications, and even death. [0006] A problem with the probes used in existing liposuction procedures is the generation of significant amounts of heat at the distal tip of the probe, which can exceed the temperature required for melting the fatty tissue. This excess heat can result in burning of tissue, damaging muscles or blood vessels, and even penetrating membranes such as the skin or the peritoneum that covers most of the intra-abdominal organs. [0007] Alternative methods have been disclosed which exploit laser energy to remove unwanted fat. U.S. Pat. Nos. 6,605,080 and 7,060,061 issued to Altshuler, et al. represent an alternative approach in which laser energy is externally applied to the skin to heat and melt fat tissues in epidermis and subcutaneous layers below. These patents disclose the use of near infrared radiation to heat-liquefy fat cells, after which the lipid pool is removed from the subcutaneous area by aspiration. Because of the considerable heat generation that results from the techniques, e.g., up to 70° C., at or in the fat tissue, a special cooling mechanism must be in place to prevent potential temporary skin damage or permanent scarring, with permanent scarring occurring primarily in the dermis. These methods present other limitations and potential adverse thermal effects on tissue above the lipid-rich tissue under treatment, including blistering, peeling, and depigmentation. [0008] U.S. Pat. No. 8,430,919 of Bornstein discloses a lipolysis method in which the skin over the target site is optically irradiated with two different wavelengths of light, one in the near infrared (NIR) region, the other in the infrared range, to modulate biochemical processes of adipocytes in the target site. In order to achieve the desired degree of fat removal, the duration of the treatment must be fairly long, from one to two hours, during which the patient must remain virtually motionless. [0009] Unless a sedative or general anesthesia has been administered to calm the patient, physical and psychological discomfort can ensue. [0010] NIR (700-950 nm) is preferable to other types of light for therapeutic use in biological systems because NIR light can pass through blood and tissue to depths of several inches. However, very few organic chromophores absorb in this region, and even fewer are capable of converting the absorbed energy into a chemical or thermal response that can be used to trigger drug release. A few years ago, gold nanostructures (shells, particles, rods, and cages) emerged as useful agents for photothermal therapy after they were shown to have strong absorption in the NIR region (four to five times higher than conventional photo-absorbing dyes) as well as tunable optical resonances. The strong absorption enables effective laser therapy at relatively low laser energies, rendering such therapy methods minimally invasive. [0011] Laser photothermal therapy of cancer with the use of gold nanoparticles immunotargeted to molecular markers has been reported as being effective to selectively kill cancer cells at lower laser powers than those needed to kill healthy cells. (X. Huang, et al., “Determination of the Minimum Temperature Required for Selective Photothermal Destruction of Cancer Cells with the Use of Immunotargeted Gold Nanoparticles”, Photochemistry and Photobiology, 2006, 82:412-417.) Gold nanoparticles absorb light efficiently in the visible region due to coherent oscillations of metal conduction band electrons in strong resonance with visible frequencies of light, a phenomenon known as “surface plasmon resonance” or “SPR”. Photoexcitation of metal nanostructures results in the formation of a heated electron gas that cools rapidly, e.g., within 1 ps, by exchanging energy with the nanoparticle lattice. The nanoparticle lattice, in turn, rapidly exchanges energy with the surrounding medium on the timescale of 100 ps, causing localized heating. This rapid energy conversion and dissipation can be achieved by using light radiation with a frequency that strongly overlaps the nanoparticle absorption band. Nanorods exhibit cylindrical symmetry, and simple changes in particle symmetry can significantly alter SPR characteristics. The NIR absorption maximum of metal nanostructures can be modulated by changing their size, shape and aggregation. GNRs have two plasmon absorption peaks, exhibiting transverse and longitudinal surface plasmon resonances that correspond to electron oscillations perpendicular and parallel to the rod length direction, respectively. The longitudinal surface plasmon wavelengths are tunable from the visible to infrared regions. The effectiveness of GNRs as photothermal therapeutic agents is strongly dependent on their scattering and absorption cross-sections—large absorption cross sections with small scattering losses allow for photothermal therapy with a minimal laser dosage. In addition, the longitudinal surface plasmon wavelengths of GNRs are preferably within the spectral range of 650-900 nm. Light irradiation in this region can penetrate more deeply into tissues and cause less photodamage than UV-visible irradiation. Therefore, the ability to tailor both scattering and absorption of GNRs with different longitudinal surface plasmon wavelengths is important for therapeutic applications. BRIEF SUMMARY OF THE INVENTION [0012] In an exemplary embodiment, the apparatus and method of the present invention combines near infrared (NIR) light exposure and a solution of gold nanorods (GNRs) that may be injected into the treatment target in order to selectively heat fat in the target area. The low power NIR light harmlessly penetrates the skin and overlying tissue to be absorbed only by the GNRs. The excited GNRs generate heat, melting the fat (lipolysis) and tightening the skin. The liquefied melted fat can be removed with a syringe or fine cannula. [0013] Only the regions into which the solution of gold nanorods has been injected are able to absorb the NIR wavelengths, which otherwise passes through the body virtually unnoticed. The amount of heating can be finely tuned by the nanorod dimensions, duration of exposure to the laser light and light intensity. [0014] In one aspect of the invention, a system is provided for minimally-invasive lipolysis in a target area, including a solution of photo-absorbing nanoparticles; means for injecting the solution into the target area; a near infrared light source for delivering a beam of light to the target area; at least one beam adjusting optical element for controlling focus and beam size within the target area; a system controller for providing control signals to the infrared light source, wherein the control signals comprise selection of an emission wavelength, an emission intensity and an exposure duration, and wherein the emission wavelength is adapted to excite the nanoparticles to melt fat within the target area; and means for extracting melted fat from the target area. In a preferred embodiment, the nanoparticles are biocompatible, and photo-absorption in the nanoparticles is mediated by surface plasmon resonance. The nanoparticles may be selected to absorb in the near infrared range (700-900 nm) and in the preferred embodiment are gold nanorods. The gold nanorods may have an aspect ratio in the range of 1:3-1:5, with an axial diameter of approximately 10 nm and a longitudinal diameter in the range of 9-50 nm. The gold nanorods may be suspended in water at a concentration of 3×10 11 GNR/mL. The near infrared light source may be a NIR laser having tunable power and/or wavelength, and further comprising beam adjusting optical means for control of beam size at the target area and may emit light within the wavelength range of 600 nm to 950 nm, more preferably in the range of 700 nm to 900 nm, and most preferably around 800 nm. In another aspect of the invention, a photothermal method is provided for in vivo fat removal by melting the fat using the system that includes a solution of photo-absorbing nanoparticles; means for injecting the solution into the target area; a near infrared light source for delivering a beam of light to the target area; at least one beam adjusting optical element for controlling focus and beam size within the target area; a system controller for providing control signals to the infrared light source, wherein the control signals comprise selection of an emission wavelength, an emission intensity and an exposure duration, and wherein the emission wavelength is adapted to excite the nanoparticles to melt fat within the target area; and means for extracting melted fat from the target area. [0015] In still another aspect of the invention, a method is provide for inducing skin tightening around regions from which adipose tissue has been removed using the system that includes a solution of photo-absorbing nanoparticles; means for injecting the solution into the target area; a near infrared light source for delivering a beam of light to the target area; at least one beam adjusting optical element for controlling focus and beam size within the target area; a system controller for providing control signals to the infrared light source, wherein the control signals comprise selection of an emission wavelength, an emission intensity and an exposure duration, and wherein the emission wavelength is adapted to excite the nanoparticles to melt fat within the target area; and means for extracting melted fat from the target area. [0016] Another aspect of the invention is a photothermal agent for melting fat and skin tightening comprising photo-absorbing nanoparticles suspended in a solution, wherein the photo-absorbing nanoparticles are adapted to convert NIR light energy into fat-melting heat in a target area in which the nanoparticles have been injected. In a preferred embodiment, the nanoparticles are gold nanorods. [0017] Yet another aspect of the invention is a kit for in vivo photothermal removal of fat in a target area irradiated by NIR light energy, the kit including photo-absorbing nanoparticles suspended in a solution, wherein the photo-absorbing nanoparticles are adapted to convert NIR light energy into heat having a temperature that melts fat; a first syringe adapted for injecting the nanoparticle solution into a target area; and a second syringe or cannula adapted for aspirating melted fat from the target area after exposure of the target area to NIR light energy for period of time sufficient to melt the fat. [0018] The combination of gold nanorods and NIR light to thermalize adipose and skin has not heretofore been disclosed. This combination offers unparalleled spatial and temporal control that no existing technique offers. The result is fat melting with ease, and minimal postoperative pain by eliminating unnecessary damage to blood vessels and nerves. It is important to note here that the prior art techniques emulsify fat, breaking it down into small globules -- they do not melt fat. This has direct implications on how the fat can be removed. As a result, the inventive technique is expeditious and minimally invasive, eliminating the need to use larger, traumatizing cannulas that are inserted through small incisions. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 illustrates an exemplary the procedure for lipolysis according to the present invention. [0020] FIG. 2 is a diagrammatic view of a kit and apparatus for performing lipolysis. [0021] FIG. 3A and 3B are plots of wavelength versus absorption, where FIG. 3A shows absorption in the visible range and FIG. 3B shows absorption with the visible range removed. [0022] FIG. 4 shows three photographs demonstrating the absence of melting under different laser heating conditions. [0023] FIGS. 5A and 5B are photographs of butter samples before and after laser irradiation with and without gold nanorods, respectively. [0024] FIGS. 6A-6B are photographs of bacon fat samples with and without gold nanorods after exposure to NIR laser heating; FIG. 6C is a photograph of bacon meat without gold nanorods after NIR laser irradiation. DETAILED DESCRIPTION [0025] Disclosed herein are a method and system which combine gold nanorods, near infrared light and minor medical procedures to reduce and remove fatty tissue. By injecting a small volume of a solution of gold nanorods into the targeted area, the invention provides for the melting of fat (lipolysis) and the tightening of skin upon illumination using a low power, biologically benign Near Infrared (NIR) laser. [0026] FIG. 1 illustrates the process flow for the inventive method, with each process step linked by an arrow to a diagrammatic image of the step as performed on a target area of a patient. The flexibility in the laser diameter, shape and intensity allows precise control over the target area, which may vary from very small, on the order of a few millimeters, to relatively large, e.g., several centimeters in diameter. In step 102 , the physician administers a subcutaneous injection into the target area of a solution of gold nanorods (GNRs) suspended in a sterile, inert liquid, e.g., distilled water, using a fine syringe. In step 104 , the GNR solution diffuses through the adipose tissue to be targeted Immediately after injection, or as soon as practically possible, NIR laser light is focused onto the target area (step 106 ) for a period that may range from a few seconds to several minutes, depending on the area and volume of the targeted fat, and at least for a sufficient period of time to induce surface plasmon resonance within the GNRs. The laser light has a wavelength within the range of 600 nm to 950 nm, preferably within the range of 700 nm to 900 nm, and more preferably about 800 nm. In step 108 , SPR is induced, producing localized heating which, in step 110 , causes the solid fat to liquefy. Finally, in step 112 , the physician inserts a syringe into the targeted area to aspirate the liquefied fat. [0027] A similar procedure may be used to heat and thus stimulate the surrounding skin to minimize sagging after adipose tissue removal. In such a procedure, the GNR solution may be applied directly to the skin or injected intradermally prior to irradiation by the NIR laser light. [0028] FIG. 2 is a representative schematic diagram of the components of the lipolysis system 10 of the present invention. The GNRs 8 (in solution) are injected into the target tissue 20 using syringe 24 . The GNRs are preferably suitable for in vivo use, for example, a polymer coating can be added for long circulation. The GNR's should be sterilized and certified endotoxin-free. The NIR laser energy 6 from the energy source 14 is directed into delivery device 16 via a delivery channel 18 , which may be a fiber optic, articulated arm, or other appropriate optical waveguide. In preferred embodiments, the NIR laser is tunable to allow selection of a wavelength that is optimized for different size GNRs. The laser should preferably have adjustable power to modulate the degree of heating. Control system 22 provides a user interface for use by the physician, or assisting nurse or technician, to select the appropriate laser wavelength, intensity, duration and other parameters that may affect the treatment. At the distal end of delivery device 16 is an energy directing means 28 for directing the pulsed energy toward the surface tissue 12 overlying the target tissue (fat) 20 . The directing means 28 may be one or more optical elements such as a lens or other focusing element, beam shaping optics, slits, apertures, gratings, an array of lenses and other optics or other focusing configuration, which focuses the beam within the targeted volume of fat containing the GNRs. In a preferred embodiment, the optical elements may include beam expanding lenses to allow adjustment of the beam spread to cover different size target areas. Following irradiation of the GNRs in the fatty tissue to liquefy the fat 20 , the liquid is aspirated using syringe 26 that is inserted into the pocket of liquefied fat. The invention further includes a kit for performing lipolysis in conjunction with an existing NIR laser unit. The kit includes the GNRs 8 in solution and syringes 24 and 26 . The syringe for extracting the liquefied fat may be replaced by a fine cannula connected to a vacuum source that is capable of generating suction at the distal end of the cannula sufficient to draw the liquefied fat from the target area and into a collection vessel. [0029] The inventive technique is possible because NIR light of low power is minimally absorbed by endogenous components in the body, such as skin, water, hemoglobin. Furthermore, low power near infrared light does not cause photodamage to tissue. NIR light is currently used for imaging using Indocyanine green (ICG), an FDA approved imaging agent able to absorb and emit in this region. While skin and adipose tissue do not absorb the NIR wavelengths, GNRs do, enabling fine tuning of the spatiotemporal parameters of heating. [0030] Because the fat is actually liquefied, the inventive method for lipolysis has the further advantage of being able to use needles or cannulas that are much smaller in diameter (on the order of 16 or 18 gauge) than those required for conventional liposuction, thus reducing patient discomfort, minimizing the risk of damage to surrounding tissue, reducing the risk of scarring and infection, and accelerating healing at the site of the procedure. Another major improvement over the prior art methods is the duration of treatment. The highly selective and rapid heating produced by the excited GNRs is capable of producing the desired results within minutes, in contrast with the multiple hours required by typical liposuction procedures. [0031] The following examples demonstrate the principles used in the present invention. Example 1 Photothermal Melting of Butter [0032] To demonstrate the selective photothermal melting of fat, we performed experiments on a ˜2 mm layer of butter sandwiched between two slides separated by a silicone spacer small. Gold nanorods (GNRs) were procured from Nanopartz™, specifically “Ntracker™ for in vivo Therapeutics” gold nanorods coated in a proprietary dense layer of hydrophilic polymers, with 10 nm axial diameter and 42 nm length. According to information provided by Nanopartz, at this aspect ratio, the plasmon absorption peaks are at 817 nm and 512 nm. Laser heating was conducted on butter samples with and without GNRs using an unfocused (˜2 mm diameter) 800 nm beam from a Ti-Sapphire (100 fs, 80 MHz) laser. The GNR-butter samples were prepared from a mixture of 10 μL of 3×10 12 GNR/mL with ˜50 mg of butter. Melting was monitored by visual inspection. [0033] The melting point of butter is 32-38° C. and its specific heat is ˜5 joules/g° C. This means that with the ˜2 mm diameter beam at 800 nm at 0.45 W power (14 W/cm 2 ), the illuminated butter sample should heat at a rate of approximately 2 degrees every second. The input heat and resulting heating rate is likely less in actuality because of absorption of the microscope slide glass. [0034] The butter sample used in these experiments shows no absorption in the region of the laser illumination wavelength, 800 nm, as shown in FIGS. 3A and 3B . The primary contribution to absorption is the fatty acids in the milk fat, which absorb in the visible range of the spectrum. The opacity of the sample limits the transmission of light through the butter so the optical density is high, as shown in the plot of FIG. 3A . If the contribution of the light scattering to the spectrum is removed, the absorption due to the butter can be better visualized, as shown in FIG. 3B . [0035] Experiments on a plain butter sample showed that melting does not occur after 3 minutes, shown in the photos of FIG. 4 , and up to 10 minutes, shown in FIG. 5A , of illumination with a 0.45 W laser beam. [0036] In the case of the GNR-butter sample under similar experimental conditions, melting of the butter was observed in the area irradiated by the NIR laser beam after 2.5 minutes of illumination. FIG. 5B shows the butter before and after irradiation. Example 2 Photothermal Melting of Meat and Fat [0037] Testing was also performed on bacon samples to compare the heating behavior in fat versus meat. We added 10 μL of 3×10 12 GNR/mL in water onto the fatty sections of the bacon and illuminated the treated sections with a ˜2 mm diameter 800 nm beam at 2.5 W power. Melting of the GNR-injected fat was observed after 45 sec in the volume traversed by the laser beam where GNRs were present. Illumination was maintained for a total of 1.5 min to further melt the fat and determine whether charring can occur when high temperatures are attained. As shown in FIG. 6A , charring was observed. The melted fat (grease) became so hot that it splattered around the fat sample, indicated by the arrows in the figure. Control experiments on similarly irradiated non-GNR fat showed no melting ( FIG. 6B ). After irradiation, the fat had the same appearance as non-irradiated samples. The irradiated meat sections without GNRs were similarly unaffected ( FIG. 6C ). These results demonstrate the highly selective nature of the heating in the GNR-injected areas of fat versus untreated areas. [0038] Experiments indicate that a solution of approximately 3×10 12 GNR/mL in water would be an effective injectable photothermal agent for melting adipose tissue upon irradiation with a NIR laser as a prelude to in-vivo fat removal. For the removal of 50 mL of fat, less than 10 mL of the GNR may be required. At the price of $500 per liter of 3×10 12 GNR/mL, the method provides an affordable alternative to conventional liposuction approaches. [0039] The application of this technology has many secondary benefits in addition to the cosmetic effect of eliminating body fat. For example, illnesses such as diabetes mellitus are directly related to fat storage and obesity. Insulin resistance can be eliminated by reducing body fat content. This scientific fact has significant implications on chronic illnesses such as diabetic nephropathy, diabetic retinopathy and coronary heart disease. To date, existing techniques have not exhibited the ability to remove an effective amount of fatty tissue without causing severe damage to adjacent tissue. In addition, during existing procedures, patients are exposed to the potentially dangerous effects of lidocaine toxicity, which is included in current tumescent solutions. [0040] The controlled thermal lipolysis protects all other vital structures, reducing post operative pain and, hence, reducing the amount of lidocaine needed in a tumescent solution and avoid life-threatening risks of lidocaine toxicity. The fact that no-to-minimal mechanical force is required to practice the inventive technique further eliminates the risk of penetrating deep tissues. Penetration of tissues such as bowels, livers and lungs has been reported in the literature with use of excessive force to achieve adequate liposuction. [0041] References: (incorporated herein by reference) [0042] 1. R.Weissleder, A clearer vision for in vivo imaging, Nat. Biotechnol. 19 (2001) 316-317. [0043] 2. S. J. Oldenburg, J. B. Jackson, S. L. Westcott, N. J. Halas, Infrared extinction properties of gold nanoshells, Appl. Phys. Lett. 75 (1999) 2897-2899. [0044] 3. L. R. Hirsch, R. J. Stafford, J. A. Bankson, S. R. Sershen, B. Rivera, R. E. Price, J. D. Hazle, N. J. Halas, J. L. 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El-Sayed, Shape and size dependence of radiative, non-radiative and photothermal properties of gold nanocrystals, Int. Rev. Phys. Chem. 19 (2000) 409-453. [0054] 13. B. G. Prevo, S. A. Esakoff, A. Mikhailovsky, J. A. Zasadzinski, Scalable routes to gold nanoshells with tunable sizes and response to near-infrared pulsed-laser irradiation, Small 4 (2008) 1183-1195. [0055] 14. G. Wu, A. Mikhailovsky, H. A. Khant, C. Fu, W. Chiu, J. A. Zasadzinski, Remotely triggered liposome release by near-infrared light absorption via hollow gold nanoshells, J. Am. Chem. Soc. 130 (2008) 8175-8177. [0056] 15. D. V. Volodkin, A. G. Skirtach, H. Moehwald, Near-IR remote drug release from assemblies of liposomes and nanoparticles, Angew. Chem. Int. Ed. 48 (2009) 1807-1809. [0057] 16. X. H. Huang, P. K. Jain, I. H. El-Sayed, M. A. El-Sayed, Plasmonic photothermal therapy (PPTT) using gold nanoparticles, Laser Med. Sci. 23 (2008) 217-228. [0058] 17. Lynch, D. J., Iverson, R. E., and the American Society of Plastic Surgeons Committee on Patient Safety. Practice advisory on liposuction. Plast. Reconstr. Surg. 113: 1478; discussion 1491; discussion 1494, 2004. [0059] 18. Beran, S. J., and Rohrich, R. J. Body contouring (overview). Select. Read. Plast. Surg. 8: 1, 1998 . [0060] 19. Weniger, F. G., Calvert, J. W., and Newton, E. D. Liposuction of the legs and ankles: A review of the literature. Plast. Reconstr. Surg. 113: 1771, 2004. [0061] 20. Pitman, G. H. Liposuction and body contouring. In S. J. Aston (Ed.), Grabb and Smith's Plastic Surgery, 5th Ed. Philadelphia: Lippincott-Raven, 1997. [0062] 21. Fodor, P. B., and Watson, J. P. Wetting solutions in ultrasound-assisted lipoplasty. Clin. Plast. Surg. 26: 289, 1999. [0063] 22. Klein, J. A. Tumescent technique for local anesthesia improves safety in large-volume liposuction. Plast. Reconstr. Surg. 92: 1085, 1993. [0064] 23. Pitman, G. H., Aker, J. S., and Tripp, Z. D. Tumescent liposuction. Clin. Plast. Surg. 26: 289, 1999. [0065] 24. Rubinstein, E. F. An anesthesiologist's perspective of lipoplasty. Clin. Plast. Surg. 26: 423, 1999. [0066] 25. Brown, S. A., Lipschitz, A. H., Kenkel, J. M., et al. Pharmacokinetics and safety of epinephrine use in liposuction. Plast. Reconstr. Surg. 114: 756, 2004. [0067] 10. Friedberg, B. L. Liposuction “conscious sedation” monitored anesthesia care and level of consciousness monitoring (Letter). Aesthetic Plast. Surg. 29: 59, 2005. [0068] 26. Rohrich, R. J., Beran, S. J., and Fodor, P. B. The role of subcutaneous infiltration in suction-assisted lipoplasty: A review. Plast. Reconstr. Surg. 99: 514, 1997. [0069] 12. Commons, G. W., Halperin, B., and Chang, C. C. Large-volume liposuction: A review of 631 consecutive cases over 12 years. Plast. Reconstr. Surg. 108: 1753, 2001. [0070] 27. Horton, J. B., Reece, E. M., Broughton, G., Janis, J. E., Thornton, J. F., and Rohrich, R. J. Patient safety in the office-based setting. Plast. Reconstr. Surg. 117: 61e, 2006. [0071] 28. Keyes, G. R., Singer, R., Iverson, R. E., et al. Analysis of outpatient surgery center safety using an internet-based quality improvement and peer review program. Plast. Reconstr. Surg. 113: 1760, 2004. [0072] 29. Trott, S. A., Beran, S. J., Rohrich, R. J., Kenkel, J. M., Adams, W. P., Jr., and Klein K. W. Safety considerations and fluid resuscitation in liposuction: An analysis of 53 consecutive patients. Plast. Reconstr. Surg. 102: 2220, 1998. [0073] 30. Fodor, P. B. Power-assisted lipoplasty versus traditional suction-assisted lipoplasty: Comparative evaluation and analysis of output (Letter). Aesthetic Plast. Surg. [0074] 29 : 127 , 2005 . [0075] 31. Gingrass, M. K. Lipoplasty complications and their prevention. Clin. Plast. Surg. 26: 341, 1999. [0076] 32. Kim, J., and Stevenson, T. R. Abdominoplasty, liposuction of the flanks, and obesity: Analyzing risk factors for seroma formation. Plast. Reconstr. Surg. 117: 773, 2006. [0077] 33. Rohrich, R. J., Broughton, G., Horton, B., Lipschitz, A. H., Kenkel, J. M., and Brown, S. A. The key to long-term success in liposuction: A guide for plastic surgeons and patients. Plast. Reconstr. Surg. 114: 1945, 2004.

1a

FIELD OF THE INVENTION [0001] The present invention relates to improvements in carry bags and, in particular, to a carry bag that stabilizes its contents by the application of a vacuum. In an especially preferred form, the invention relates to a backpack which includes an inner airtight bag which may be evacuated of air by a suction device for compressing the bag tightly and sealably against the contents of the bag. BACKGROUND OF THE INVENTION [0002] For ease of understanding, the term “carry bag” as used in this specification embraces such items as backpacks, rucksacks, satchels, knapsacks, handbags, suitcases, riding or saddle bags, duffel bags, motorcycle panniers, and webbed carry pouches, such as those used by the military. All of these carry bags are designed to reliably envelope, and provide some degree of restricted access to, their contents, as well as provide a means of conveyance to the user, such as by handles, straps, buckles or latches. [0003] However, there are numerous well known problems or limitations of such carry bags, one of which is the inability to tightly secure the carry bag contents. For example, prolonged chaotic movement, as is the case with a runner's backpack, can cause damage to, and rearrangement of, its contents, leading to discomfort to the bearer of the carry bag. The problem is exacerbated when the carry bag is not full, notwithstanding the careful and often time consuming packing of contents and the use of securing straps incorporated in some bags. [0004] Another problem arises where the carry bag is oversized relative to its contents. It is desirable in any circumstance of transportation with a carry bag for the contents to occupy a minimum volume for avoiding snagging the carry bag, for maximizing packing space externally of the carry bag, and for optimizing the centre of mass with regard to the transporting person or vehicle. Where a carry bag is not packed to capacity or the contents are compressible, it is difficult to efficiently reduce the overall volume of the carry bag and its contents. Some carry bags include a means of restricting volume by a strap or drawstring, but these devices are only partly effective in reducing volume and may malfunction during prolonged periods of use. [0005] Waterproofing of carry bags is another problem that has not generally been addressed. Many carry bags are designed for circumstances where rain or at least partial immersion in water is possible. They often employ watertight material and a means of enclosure that averts entry of rain water, such as a drawstring controlled opening with a flap cover. However, these carry bags are ineffective in heavy rain and cannot withstand immersion in water, and thus require, as a special precaution, the contents to be separately waterproofed before being packed into the carry bag. [0006] Although various attempts have been made to address any one or some of the aforementioned problems and limitations, no carry bags have yet been identified in the prior art by the inventor that address all of those problems and limitations, and provide a sealable, waterproof carry bag which comprises, or includes an inner bag which comprises, flexible walls in order to restrain its contents from movement by compressing the walls against the contents when air is evacuated from the bag by a suction device. [0007] For example, prior art patent document WO 03/056975 discloses an adjustable backpack compression-suspension system which allows the pack to be easily shifted from the load carrying position at the back of the wearer to an access position at the side or front of the wearer, which system stabilizes and compresses the load in the carrying position. The pack has a waist belt at its lower edge, and opposite side edges of the pack are tethered to the sides of the belt by the compression-suspension system which attaches to the pack by a strap at multiple spaced-apart locations. The system includes several straps which are subject to tensioning force and thus adjustable to laterally compress and stabilize the pack and its contents in a comfortable position. [0008] Prior art patent document U.S. Pat. No. 6,047,413 discloses a protective garment having a backpack portion adapted to conform to equipment worn on a back of a wearer of the protective garment. The backpack portion includes an outer protective layer that is gathered, and a plurality of elastic members are connected to an interior surface of the outer protective layer so that it is drawn toward and conforms to the worn equipment. [0009] Other prior art apparatus and methods for compressing carry bags and their contents are disclosed in patent documents U.S. Pat. No. 5,987,644; U.S. Pat. No. 5,361,955; and U.S. Pat. No. 6,024,265. [0010] None of the aforementioned prior art documents disclose the use of a vacuum created after packing and sealing contents into an airtight inner bag contained within a carry bag to reduce the volume of the inner bag for the purpose of compressing the contents against the carry bag and hence immobilize the contents. [0011] It is, therefore, an object of the present invention to overcome, or at least substantially ameliorate, the shortcomings and disadvantages of the aforementioned prior art, or at least provide a useful alternative. SUMMARY OF THE INVENTION [0012] According to the invention, there is provided a carry bag comprising flexible walls defining an enclosure adapted to house contents of the bag, the enclosure having an opening for receiving the contents therethrough, the opening being sealable for airtightness of the enclosure, and means for evacuating air from the enclosure so as to compress the walls against the contents to thereby restrain the contents from movement. [0013] In a preferred form, the enclosure is an inner bag of the carry bag. [0014] Preferably, the air evacuating means is a suction pump. [0015] It is preferred that the walls of the inner bag and its contents are compressed against a rigid support wall of the carry bag. [0016] In a particularly preferred embodiment, the carry bag is a backpack having a rigid support wall adapted to abut against the back of a user, and including an inner bag having flexible walls and a sealable opening that allows contents to be packed and sealed within the inner bag and for a vacuum to be created and maintained when the opening is sealed. The inner bag is coupled to an air pump that, in use, evacuates air from the inner bag so as to cause the contents to be tightly secured against the rigid support wall, thereby reducing the volume of space occupied by the carry bag. BRIEF SUMMARY OF THE DRAWINGS [0017] In order that the invention may be readily understood and put into practical effect, reference will now be made to the accompanying drawings, in which: [0018] FIG. 1 is a partly disassembled, perspective view of a carry bag according to a first preferred embodiment of the invention, [0019] FIG. 2 is a schematic, side view showing two stages in the evacuation of air from an enclosure forming part of the carry bag of FIG. 1 , [0020] FIG. 3 is a perspective view of a carry bag according to a second preferred embodiment of the invention showing a first stage of use, [0021] FIG. 4 is a similar view to that of FIG. 3 but showing a second stage of use, [0022] FIG. 5 is a similar view to that of FIGS. 3 and 4 but showing a third stage of use, [0023] FIG. 6 is an enlarged and isolated view of a valve arrangement for suction means used in the carry bag as shown in FIG. 5 , [0024] FIG. 7 is a perspective view of a carry bag according to a third preferred embodiment of the invention, [0025] FIG. 8 is a rear view of the carry bag of FIG. 7 , [0026] FIG. 9 is a side view of the carry bag of FIG. 7 showing contents and an airtight inner bag enclosing same which has not been evacuated of air, [0027] FIG. 10 is a view similar to that of FIG. 9 but in which air has been evacuated from the airtight inner bag to compress the contents against a rigid support wall of the carry bag, [0028] FIG. 11 is a perspective view of a carry bag according to a fourth preferred embodiment of the invention supported on a motorcycle, [0029] FIG. 12 is a side view of the carry bag shown in FIG. 11 showing contents and an airtight inner bag enclosing same which has not been evacuated of air, [0030] FIG. 13 is a view similar to that of FIG. 12 but in which air has been evacuated from the airtight inner bag to compress the contents against a rigid support wall of the carry bag, [0031] FIG. 14 is a perspective view of a carry bag according to a fifth preferred embodiment of the invention showing a first stage of use, [0032] FIG. 15 is a view similar to that of FIG. 14 but showing a second stage of use, [0033] FIG. 16 is a view similar to that of FIG. 15 but showing a third stage of use, [0034] FIG. 17 is a view similar to that of FIG. 16 but showing a fourth stage of use, [0035] FIG. 18 is a view similar to that of FIG. 17 but showing a fifth stage of use, [0036] FIG. 19 is a side view of a carry bag according to a sixth preferred embodiment of the invention showing a first stage of use, [0037] FIG. 20 is a view similar to that of FIG. 19 but showing a second stage of use, [0038] FIG. 21 is a rear view of a carry bag according to a seventh preferred embodiment of the invention showing a first stage of use, [0039] FIG. 22 is a view similar to that of FIG. 21 but showing internal detail, [0040] FIG. 23 is a perspective view of the carry bag of FIG. 21 , [0041] FIG. 24 is a side sectional view of a pump assembly that may be used in or with the carry bag of the invention, the pump assembly being shown in an open configuration, and [0042] FIG. 25 is a similar view to that of FIG. 24 , but showing the pump assembly in a closed configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0043] The carry bag 10 shown in FIG. 1 includes a base plate 12 , an airtight bag 14 with a ziplock opening 16 and a suction pump coupling 18 attached to the airtight bag 14 , and a protective outer sleeve 20 with a suction pump 22 attached thereto. Air can be evacuated from the bag 14 to compress any contents 24 therein against the base plate 12 in the manner as shown schematically in FIG. 2 by connecting the suction pump 22 to the coupling 18 and operating same. [0044] The carry bag 30 shown in FIGS. 3 to 5 is used, in a first stage, to receive contents through an outer sealable opening 32 . The opening 32 is then closed to provide an airtight enclosure around the contents, and a hand pump 34 is then operated to evacuate air from the airtight enclosure. Flexible walls of the enclosure compress against the contents and hold them tightly in place. The one way valve 36 shown in FIG. 6 ensures that air cannot return into the enclosure during and after the operation of the hand pump 34 . [0045] The carry bag 40 shown in FIGS. 7 to 10 is similar in structure and function to the carry bags described above, but is adapted specifically for use as a backpack. Like features between the carry bags have been assigned like numerals in the drawings. FIG. 10 , in particular, identifies the inner bag 14 evacuated of air and its walls and the contents enclosed therewithin compressed against the rigid support wall 42 . [0046] The carry bag 50 shown in FIGS. 11 to 13 is adapted specifically for use as a pannier for a motorcycle. Again, like features have been assigned like numerals in the drawings. [0047] The carry bag 60 shown in FIGS. 14 to 18 is used, in a first stage, to receive contents 62 through an outer sealable opening 64 . The opening 64 is then closed to provide an airtight enclosure 66 around the contents, and a hand pump 68 is then operated to evacuate air from the airtight enclosure. Flexible walls 69 of the enclosure compress against the contents and hold them tightly in place. The volume of space occupied by the carry bag 60 has thus been significantly reduced and the contents are prevented from movement relative to the bag. [0048] The carry bag 70 shown in FIGS. 19 and 20 is similar in structure and function to the carry bags described above, but is adapted specifically for use as a backpack. FIG. 20 , in particular, identifies an airtight bag 72 evacuated of air and its walls and the contents enclosed therewithin compressed against a rigid support wall 71 . [0049] The backpack 70 includes a stiffened base plate which serves as the support wall 71 , an airtight bag 72 having a flexible wall with a ziplock opening 74 that provides an airtight resealable closure, a one-way air valve 76 mounted to the flexible wall, and a flexible air hose 78 connected at one end to the valve 76 and at the other end to a vacuum pump 80 . Air can be evacuated from the bag 72 to compress contents 82 of the bag against the rigid support wall 71 in the manner as shown schematically in FIG. 20 by manually operating the vacuum pump 80 (according to a reciprocating or pumping motion of the pump). The outward flow of air from the bag 72 and through the air hose 78 is shown by arrows A, and the inward movement or compression of the flexible wall of the bag against the contents 82 is shown by arrows B. The backpack 70 can thus be worn with the aid of shoulder straps 84 by a user and, as the flexible wall of the airtight bag 72 firmly follows the outermost shape or profile of the contents 82 , the contents will not move relative to the backpack during even violent movement of the user wearing same and the total volume of space occupied by the backpack 70 is significantly reduced. [0050] The carry bag 90 shown in FIGS. 21 to 23 is similar in structure and function to the carry bags described above, but is adapted specifically for use as a medium sized backpack, also known as a daypack. It has a very light weight structure consisting of an airflow or breathable vest 92 , a cavity 94 for a hydration container, say, for a sports beverage, and dual waterproof independent chambers (only a single chamber 96 shown) which are capable of being evacuated of air therewithin by a pump device 98 . The daypack also has foam ribs 97 for back aeration and a waste strap 99 with a foam support. [0051] The pump assembly 101 shown in FIGS. 24 and 25 may be used in or with any one of the carry bags described above. The pump assembly 101 utilizes two simple one way valves. An inner, smaller valve 102 maintains an airtight seal of the bag when the pump assembly is not in use. To this end, the pump assembly has been designed to close off the inner valve 102 by means of an extension 103 to a top moulding of a valve cap 104 , which clamps down on the inner valve 102 when the pump assembly is shut after use. There is a bayonet style fitting between the top and bottom mouldings. The valves are of a conventional kind found on rubber inflatables and on simple foot pumps used for camping, and have thin rubber sheets that act as a type of diaphragm seal. The concave form of the valves ensures that they remain in a closed state unless forced open by pressure from beneath or within the carry bag [0052] It will be readily apparent to persons skilled in the art that various modifications may be made in details of design and construction of the carry bag described above without departing from the scope or ambit of the present invention.

1a

RELATED APPLICATIONS This application is a continuation-in-part of my co-pending U.S. application, Ser. No. 820,708, filed Aug. 1, 1977, now abandoned. BACKGROUND OF THE INVENTION Through the ages man has been a hunter. Formally he did it for survival. Today more often it is for sport. One problem that hunters, especially gun hunters, have had is the lack of a handy way of carrying ammunition to which ready access can be gained. Oftimes lone shells are carried in pockets and precious time is lost when the hunter has to fumble to find a few shells to reload his shotgun or rifle, especially when a prospective target is nearby. Applicant is aware of the container of Capua, U.S. Pat. No. 3,332,594 but such does not provide quick access to the bullets. The dispenser of Black, U.S. Pat. No. 3,219,244 suffers from the possibility that the bottom resilient member could be actuated thereby inadvertently dispensing ammunition through body movements of the wearer. SUMMARY OF THE INVENTION The invention herein is seen to comprise a box having a base and a removable self-locking lid, which lid is additionally secured to the base to prevent loss thereof. The container is seen to be compact, easily loaded with shells and can be readily secured to the belt or clothing of the user. Accordingly, it is an object of this invention to provide a compact durable shell container for use by hunters. Another object is to provide a container suitable for the storage of shotgun shells or other ammunition which is light in weight and easy to manufacture. Still another object is to provide a shell container which is substantially water tight and which allows for ready access by the shooter to the contents. Other objects of the invention will in part be obvious and will in part appear hereinafter. The invention accordingly comprises the product possessing the features, properties and the relation of components which are exemplified in the following detailed disclosure, and the scope of the application of which will be indicated in the claims. For a fuller understanding of the nature and objects of the invention, reference should be had to the following detailed description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a bottom perspective view of one embodiment of this invention. FIG. 2 is an exploded perspective view of the device of this invention wherein one sidewall of the bottom section and the lid have been removed. FIG. 3 is an exploded perspective view of the container constructed in accordance with one embodiment of this invention. FIG. 4 is a rear elevational view of a second embodiment of the bottom portion of this invention. FIG. 5 is a perspective view of another embodiment of this invention wherein the container is in an open position. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference to FIG. 1, there is provided container 100 constructed in accordance with the invention as shown in the open position. The container 100 comprises a box or bottom 17 having a bottom wall 20 and substantially vertically extending sidewalls 12. One such wall has been designated as 12A to illustrate which wall is cut away in FIG. 2. Per FIG. 3 the upper portion of the sidewalls 12 has a round ridge 14 molded on the exterior surface of the front and rear walls, and a similar ridge 40 molded into the side walls in axial alignment therewith. The rear wall has a belt clip 16 integrally or otherwise fixedly attached thereto. The detachable lid 13 consists of a top 33 having at the edges thereof downwardly depending sidewalls 34. Tab 31 is disposed at the corner forming the junction of two of the walls 34, here shown to be the rear and right side wall. It is preferable for said tab 31 not to project rearwardly to avoid interference with the location between the wearer's belt and clip 16. If desired tab 31 could extend forwardly. While shown at one corner, it is within the scope of the invention for the tab to be disposed at any location along the length of right side wall 34. Indeed the tab 31 could be placed on side wall 34A, the left side wall if desired. Tab 31 has a central aperture 32 therethrough for the insertion of connecting string 37 which is knotted at one end 38 to attach it to the tab 31. A similar tab 35 having an aperture 36 therein is disposed normal to the right side wall 12 of box 17. All of the comments pertinent to the disposition of tab 31 are pertinent here as well. For style and ease of operation, the two tabs should preferably be facing the same direction and more preferably in vertical alignment, as shown. However, preferably the apertures 32 and 36 are horizontally disposed. The opposite end of string 37 is knotted at 38 through aperture 36 to thereby detachably secure lid 13 to box 17. If desired, tabs 31 and 35 may be oriented 90° to provide vertical apertures. In FIGS. 2 and 3 one embodiment of container 100 is further illustrated. The box side walls 12 are shown as they engage the bottom of the container 20. The ridges 14 and 40 are shown as they are molded to the upper portion of box side walls 12. The lid top 13 is shown separated from box 17 due to the absence of string 37. Inwardly extending groove 15, in phantom in FIG. 3, and in FIG. 1, is shown as it is constructed into the lower portion of the internal surface of the downardly depending walls 12 of the lid. It is to be noted that left side wall 12 is designate 12A in FIG. 3 to further indicate the fact that it is this wall that is missing in FIG. 2. Disposed along substantially the entire depth of wall 12A at a convenient elevation, preferably around the middle for proper balance, is disposed a strip of Velcro® 49. The Velcro® material 49 may be adhesed to wall 12A by a suitable glue or self-adhesive Velcro® available in the marketplace. Velcro® is an engaging means comprising a pad of nylon hooks which engages a pad of complimentary loops for forming a detachable bond of one time to another. Velcro® is a well known material available in the marketplace from Velcro S.A. of Friebourg, Switzerland or its licensee. It is to be seen that preferably, as illustrated here, the tabs 31 and 35 are disposed on the opposite side wall from Velcro® strip 49. The choice of left or right for either is at the choice of the practitioner. Lid 13 is seen to include a similar Velcro® strip 19 of convenient size disposed on the top outside surface thereof. At the midportion of the clip there is shown another Velcro® strip 19 which can serve to better secure the clip to the belt of the wearer by engaging the fabric of the trousers, thereby adding in the disposition of the clip at its desired position on the belt. Obviously this additional strip is optional. Demonstrating the intended use of the invention, an array 11 of shotgun shells, stacked five rounds wide and five rounds tall, is shown in FIG. 3. While shown in the preferred orientation, horizontal, for easier handling and quicker removal, it is within the scope of the invention, but less preferred, to size the container for vertical storage of the shells 11. Thus, the container can be adapted to maintain all guages and lengths of shotshell or other ammunition securely. The application of the detachable lid 13 is accomplished by a downward vertical pressure until the groove 15 on the lid side walls as aforesaid engages the ridge 14 of the box side walls. With the presence of ridges 40, they would also engage their appropriate groove 45 until the ridges snap into the lid whereby the bottom becomes removably secured to the lid. When lid 135, per FIG. 5 is employed, it is seen that upon engagement of ridge 14 with groove 15, gasket 395 will assume a contact relationship with lip 46, the surface of thickness of wall 12, to help ensure an even better water tight seal. At all times string 37 will remain almost taut since little extra should be provided such that when the lid is detached and then let go, it will dangle but a few inches from the box, again saving time for re-location when it is desired to reseal container 100 after removing the desired shells. With the detachable lid closed, the shotshell container may be turned in any position while maintaining the contents securely. Removal of the detachable lid requires upward vertical pressure until such time the grooves 15 and 45 if present of the lid disengage the ridge 14 and 40 if present of the box side walls. The shotshell container is intended for loose storage of shotshell ammunition in such a manner that the ammunition need not be retained in the array when the detachable top is removed, but may be moved or shifted for convenient access. FIG. 4 is a sectional view of an alternate belt clip. Clip 26 is seen to include an integral nonspring vertical extension 25 which attaches to the leading edge thereof and preferably formed therewith. Extension 25 is held in abutting relationship to side wall 12 by rivet 28 inserted into aperture 29 in said plate 27, through the aligned apertures 30 of said wall 12. Optionally, a retainer plate 27 may be juxtaposed against the inside of wall 12 such that apertures aligned with apertures 29 would extend through. Such retainer plate can be of thin steel or aluminum and is intended for reinforcement of the plastic wall 12. It is to be understood that while two rivets are shown securing clip 26 and its extension 25 more or only one need be or can be employed. Clip 26 and extension 25 may be constructed of steel, for example. The embodiment of FIG. 5 is similar to that of FIG. 3, except for the presence of lid 135 without ridges 45. While a lid 13 such as shown in FIG. 2 or FIG. 3 having both grooves 15 and 45, it is preferable to employ a lid such as 135 which has only grooves 155 therein, re front and back. The absence of side grooves increases the strength of lid 135 since such grooves would receive no ridges. In addition, to ensure a tight seal to protect ammunition 11 from water contact, gasket 395 usually of synthetic rubber may be either separatedly adhesed onto the surface of the interior of top wall 335 of lid 135 or the gasket may be integrally cast into place in same at the time of manufacture using conventional technology. Reference is made to FIG. 5 wherein the tab is designated 315 with its aperture designated 325. Obviously the concept of employing an extra gasket such as 395 is equally applicable to lid 13, and it is within the scope of the total invention to include same and such would be designated 39. It is also seen that it is just as applicable to employ the clip mechanism of FIG. 4 for the container structure of FIG. 5 as well. From the point of view of manufacture, the embodiment of FIG. 3 is best made having a flexible lip 13 such as one made of polypropylene or polyethylene. If a more rigid plastic, such as ABS, were used, it might be difficult to remove the lid from the bottom. Therefore ABS and other rigid plastics, such styrene, should preferably be employed for the embodiments of FIG. 5. In any event, the box of said container should have rigid sidewalls, and the walls of the lid, at least those having the grooves therein should possess some degree of flexibility to permit opening and closing of the container. The ammunition container of this invention with its self-locking lid, which remains secured to the box even after unsealing of the lid, is seen to possess many advantages over the prior art, such as ease of opening and closure and the ability to be cheaply and easily manufactured. While the forms of apparatus described constitute the preferred embodiments, it is to be understood that the invention is not to be limited to the forms of the apparatus as presented herein, and that changes may be made therein without departing from the scope of the invention. As is seen, Velcro® strips 19 and 49 have been provided to allow alternate mount means for the container 100 of this invention upon the clothing of the wearer. Thus, a hunter having a strip of complimentary Velcro® on his sleeve, or elsewhere, could secure the device of this invention to his sleeve or such other location as possessed the complimentary Velcro®, e.g. a boot. A Velcro® strip on the side wall having tab 35 is not suggested as the user may believe he should attach the removed lid thereto whereas in fact quicker replacement of the lid to the box can be attained if the lid is allowed to dangle free after separation from the box.

1a

This is a continuation-in-part of application Ser. No. 08/065,807, filed on May 21, 1993 now U.S. Pat. No. 5,312,368. BACKGROUND OF THE INVENTION The present invention relates to a protective device for a hypodermic syringe and more importantly to a protective device that normally and automatically envelopes the needle of a hypodermic syringe. There have been many attempts to make protective devices to protect users of hypodermic syringes from inadvertent punctures. This has become a particular concern now with the consequences of AIDS. To Applicant's knowledge, these prior attempts have all been attempts to conceal the needle during transport, either before or after use. The known devices typically require manual movement of a sheath or similar protective member to expose the needle so that the needle can be used and once an injection is made, manual movement of the sheath to conceal the needle so that the needle can be disposed of without inadvertent puncture. These known sheaths do not address the danger of an exposed needle during the period just prior to use through just after the injection during which the sheath does not conceal the needle. For example, there is the possibility that during the injection the patient will jump and the needle will be dropped or it may be propelled into the air. The Applicant is aware of instances where the needle has been propelled and inadvertently stuck the individual giving the injection. The only protective sheaths that the Applicant is aware of that provide protection during the period of use employ a coil spring to automatically extend the sheath. These protective sheaths either require too much manipulation or are too costly. SUMMARY OF THE INVENTION The protective devise of the present invention overcomes the above problems found in known devices by providing an inexpensive automatic shield that normally conceals the needle of a hypodermic syringe and has to be manually biased to expose the needle. The protective shield of the preferred embodiment of the present invention is a clam shell type design having two members that are normally closed about the needle of the syringe. The shield includes a mounting collar that is preferably slip fit over the end of the base of the needle or syringe body. The two members are hingedly connected to the mounting collar so that they can pivot with respect to the needle. In order to expose the needle, the two members are pivoted about the hinge with respect to one another. In the disclosed embodiment, there are finger grips provided to facilitate the pivoting of the two members. The hinge is formed so that it biases against the members, biasing them back to the normal position corresponding to the closed position. In this way, due to the bias, the two members are automatically returned to the concealing position if the manual applied force on the members is released, as for example if the needle and syringe is dropped or knocked from the user's hand. As should be appreciated by one of ordinary skill in the art, the sheath would not need to be removed from the needle for use which greatly reduces the potential for contamination. Further, as soon as the needle is inserted, the force to open the sheath can be released and the two halves of the sheath, because of the resilient memory of the material used, will automatically close the two halves against the skin of the patient. Since there are only a few ounces of force needed to close the two members, the patient feels no discomfort. When the needle is removed, by purpose or accident, the sheath snaps shut, covering the needle. The present application also discloses an alternative embodiment of the present invention wherein there is only one pivotal member that has an open side for exposing the needle. The one member or arm is pivoted against the bias of the hinge in a manner similar to the above clam-type shield. This application also discloses further embodiments, including added means for protecting against inadvertent opening of the protective arms. These means take the form of a protective door and a locking brace. Still further, there is a pocket disclosed for added concealment of the needle. There is also disclosed various methods for making the shield of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of the protective shield of the present invention mounted upon the base of the needle attached to a hypodermic syringe. FIG. 2 is a plan view of the protective shield of the present invention. FIG. 2 A is an end view of the preferred embodiment of the present invention. FIG. 3 is a plan view of the protective shield attached to the base of the needle of the present invention in the exposed position. FIG. 4 is a side view of a second embodiment of the present invention. FIG. 4 A is an end view of the shield illustrated in FIG. 4. FIG. 5 is a further embodiment of the shield of the present invention. FIG. 6 is a top view of the preferred mold for injection molding the shield of the present invention with the top of the mold removed. FIG. 7 is a cut away side view of the preferred mold for injection molding of the shield. FIG. 8 is a view taken along line 8--8 of FIG. 7. FIG. 9 is a view of the protective shield mounted to the end portion of a hypodermic syringe. FIG. 10 is a perspective view of a further embodiment of the shield of the present invention. FIG. 11 is a cross-section taken along line A--A of FIG. 12. FIG. 12 is a plan view of the embodiment of FIG. 10. FIG. 12 A is a top view of the embodiment of FIG. 10 with the two halves of the needle shield open. FIG. 13 is a perspective view of FIG. 12 A . FIG. 14 is a perspective view of a further embodiment of the shield of the present invention with the disclosed two halves open. FIG. 15 is a plan view of FIG. 14. FIG. 16 is a perspective view of the shield of FIG. 14, with the two halves joined and illustrating the movement of the protective arm. FIG. 17 is a cross-section taken along line 17--17 of FIG. 16. FIG. 18 is a side view of FIG. 16. FIG. 19 is a partial cross-section of a further embodiment of the sheath of the present invention. FIG. 20 is a partial plan view of a still further embodiment of the present invention. FIG. 21 is a partial top view of the connector body and finger grip of the shield illustrated in FIG. 20. FIG. 22 is a partial view of FIG. 20. FIG. 23 is a cross-section taken along line 23--23 of FIG. 20. FIG. 24 is a side view of a syringe with a further embodiment of the present invention attached. FIG. 25 is a top view of the sheath illustrated in FIG. 24. FIG. 26 is a side view of the shield of FIG. 24. FIG. 27 is a front perspective view of the shield of FIG. 24. FIG. 28 is a rear view of the shield of FIG. 24. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The protective hypodermic needle shield of the present invention is shown generally at 10 in FIG. 1. The shield 10 is mounted upon the base 19 of needle 18 on a standard hypodermic syringe 12 (see FIG. 3). The syringe 12 includes a barrel 14 which receives a plunger 16 at one end and has a hypodermic needle 18 attached at the opposite end. It is to be understood that syringe as used in this application, refers broadly to the barrel, needle and base of needle, and any hub or end portion of the barrel. The disclosed hypodermic syringe includes a coupling 20 that couples the base 19 of needle 18 to the barrel 14. The coupling 20 allows the needle 18 to be removed from barrel 14. It should be understood that the needle 18 could be integrally formed to the barrel 14 without affecting the application of the present invention. It is also within the scope of this invention that the protective shield 10 can be mounted to the end of the syringe 12 adjacent to the needle 18 or mounted to the barrel 14 of the syringe 12. With reference to FIG. 2, the shield 10 of the present invention is shown in greater detail. The shield 10 has a connector body 22 which slide on the base 19 of the needle 18. The shield is generally installed on the needle at the time of assembly. With reference to FIG. 3, Luer-Lok tabs 23 are illustrated for example as a known method of attaching the needle 18 to barrel 14. Tabs 23 molded are into base 19 of needle 18 onto which the connector body 22 slides. The vertical projections normally found on the base 19 of the needle are not illustrated, but those of ordinary skill in the art will appreciate that these projections are received within grooves to receive the projections to prevent slipping. Syringes with a slip-tip would not require the grooves. As should be appreciated, other methods of preventing the sheath of the present invention from slipping will become apparent to those of ordinary skill in the art and are considered to be within the scope of this invention. As illustrated in FIG. 2, the protective arms 24 and 26 each have a semicircular cross-section. The arms 24 and 26 are illustrated in the closed position wherein the arms mate to form a circular cross-section with a closed end 30 to envelope the needle 18. The closed position is the normal position for the arms 24 and 26 so that the needle 18 normally remains enveloped preventing inadvertent puncture by the needle 18. The sheath is generally tubular in shape and has a slight taper from its top 34 to end portion 30. The inner diameter 36 of connector body 22 is made to fit the outer diameter of the base 19 of needle 18, or the end portion 21 of the barrel 14 if there is no coupling 20 or the barrel 14 if it is desired to mount shield 10 to the barrel 14. This permits the connector body 22 to be slip fit onto syringe 12. As disclosed, the arm 24 terminates in an end face 28. The arm 26 terminates in an inwardly turned end portion 30 that abuts against the inner wall 32 of arm 24 to cover the terminal end of the needle 18. In this way, the needle is fully enclosed. As stated above, the arms 24 and 26 are normally in the closed position as illustrated by the solid lines in FIG. 2. To expose the needle 18, the arms 24 and 26 must be pivoted with respect to the syringe 12. The pivoting action is shown by the phantom lines in FIG. 1 and 2. In order for the arms 24 and 26 to pivot, the sheath has a reduced outer diameter at 40. In the embodiment illustrated in FIGS. 1 and 2, the reduced diameter is defined by intersecting angled walls 42 and 44 which intersect at the top 46 of the arms 24 and 26. The reduced diameter 40 defines flexible hinges 48 between the arms 24 and 26 and the connector 22 which bias arms 24 and 26 to their closed position to conceal the needle 18. Protruding outwardly from the arms 24 and 26 are finger grips 50 and 52. In the preferred embodiment of the invention, the finger grips 50 and 52 are integrally formed with the remainder of the shield 10. As illustrated in FIGS. 1 and 2, the top of the finger grips define the angled wall 44 of reduced portion 40. With reference to FIG. 3, the fully open position of sheath 10 is illustrated. The arms 24 and 26 are generally perpendicular to the syringe 12 fully exposing the needle 18. In this position the fingers 50 and 52 are pressed by the user against the connector body 22. It should be understood that the hinges 48 are biasing the arms 24 and 26 to the normally closed position as shown in FIGS. 1 and 2. The user is responsible for holding the arms 24 and 26 in the illustrated position to expose the needle 18. If the user releases the fingers 50 and 52 the arms 24 and 26 will automatically be forced back to the closed position concealing the needle 18. To facilitate the users ability to hold the arms 24 and 26, finger grips 50 and 52 are slightly concave to conform to the user's finger and thumb. Knurling can also be used to facilitate gripping. With reference to FIG. 4, a further embodiment of the shield 10 of the present invention is shown generally at 54. This embodiment is generally the same as the previous embodiment, except that it has a square cross-section, see FIG. 4 A as opposed to a circular cross-section, see FIG. 2 A . It should be understood by those of ordinary skill in the art that the cross-section could have other geometric shapes, for example it could have a triangular cross-section with the arm 24 being generally flat in cross-section and the arm 26 having a triangular cross-section. With reference to FIG. 5, another embodiment of the shield of the present invention is shown generally at 56. As before, the shield 56 has a connector body 22 for a slip fit connection to the base 19 of needle 18. In this embodiment, instead of two arms 24 and 26, there is a single arm 58 which is hinged at 60 to connector body 22. One side of arm 58 has an opening wide enough to let the needle 18 pass through during movement. A single finger 62 is used to pivot the arm 58 from the normally closed position, in which the needle 18 is covered, to the fully exposed position, in which the needle is fully exposed. The arm 58 is generally perpendicular to the needle 18 in the fully exposed position. As before, the hinge 60 resists efforts to pivot the arm 58 from the normally closed position, i.e. generally parallel to the needle 18, to the fully exposed position, i.e. generally perpendicular to needle 18. As can be appreciated, the arm 58 will automatically return to the closed position. In this embodiment the top 64 of arm 58 extends across the base 66 of connector 22. In the previous embodiment, the tops 46 of each arm 24 and 26 extended only about one-half the distance across the base of the connector 22. Additionally, in this embodiment the end 68 extends at a generally right angle with respect to the arm 58 to cover the end of needle 18 when the arm is in the closed position. With reference to FIG. 6, a preferred mold and method of making the sheath 10 of the present invention will be described. The mold is shown generally at 70. The mold has two halves, a top half 72 and a bottom half 74 that can be separated along a longitudinally extending part line 73. The mold halves 72 and 74 form cavities which define the exterior of the sheath 10. The cavity 76, formed by the two molds 72 and 74, has a first inside diameter 78 that tapers slightly to an inwardly angled portion 80 that corresponds to wall 42. The inwardly angled portion 80 ends at an apex 84 which begins the outwardly angled portion 82 that corresponds to the wall 44. The angled portion 82 extends to a generally perpendicular cavity 86 relative to the center line that defines the fingers 50 and 52. The perpendicular cavity 86 is formed on both the top half 72 and bottom half 74 of the mold 70. Extending into the top half 72 and the bottom half 74 is a tapered cavity 88 that defines the outer surface of the arms 24 and 26. A core insert 90 is adapted to be inserted into the cavities 72 and 74. Core insert 90 defines the interior of the sheath 10. The insert 90 is slightly tapered along its length. To define the two arms 24 and 26, longitudinal blades 92 are inserted project in from the molds 72 and 74 on opposed sides of the insert 90. The blades 92 extend in to the insert 90, which has shallow grooves to accept them. As should be appreciated, the blades will form a line of separation on both sides of the arms 24 and 26 when they are molded. A second pair of smaller blades 94 are inserted or projected in from the molds 72 and 74, which are generally perpendicular to the blades 92. It should be appreciated that the blades 94 will have an interior shape that is the same as the exterior shape of core insert 90. The blades 94 define the tops 46 of the arms 24 and 26. In the preferred embodiment, blades 94 are inserted in grooves cut in the top half 72 and bottom half 74. Also, blades 92 are inserted in grooves cut in the top half 72 and bottom half 74. The blades 92 abut blades 94 when closed. Shallow grooves are cut in insert 90 to accept the blades 92 and 94 when closed. With insert 90 in place to mold sheath 10, the top 72 and bottom 74 of the mold 70 are connected together by means well known to those of ordinary skill in the art. An engineered material is then injected into the cavity to form sheath 10. Once the material has obtained the shape of the cavity and sets, molds 72 and 74 are separated to enable the sheath 10 to be removed. It should be appreciated that the material to be used for the sheath 10 will require the necessary physical and mechanical properties such that the needle will automatically be protected by arms 24 and 26 after release of fingers 50 and 52 which control exposure of needle 18. It is believed that a plastic such as polypropylene will be acceptable, but it is believed that other spring type material would be acceptable. It should be understood that the other embodiments could be molded in a similar mold with slight variations to the mold. The mold of the preferred embodiment permits sheaths to be quickly and inexpensively molded. With reference to FIG. 10, a further embodiment of the present invention is illustrated at 120. Sheath 120 includes a connector body 122 for connecting the sheath 120 to a syringe 12. It should be understood that connector body 122 can be dimensioned to connect the sheath 120 to the end 111 of the syringe 12 as illustrated or to the body 14, or to the needle 18, or to the coupling 20 as shown in FIG. 1. It should be further appreciated by those of ordinary skill in the art that the inside diameter and, if desired, the outside diameter of the connector body 122 would be appropriately dimensioned to facilitate mounting of the connector body 122 to the desired location. Extending from the connector body 122 are protective arms 124 and 126, which include a pair of end faces 128. As previously described, the end faces 128 conceal the end of needle 18 to prevent inadvertent punctures. As in the previous embodiment, fingers 150 and 152 are provided to permit manipulation of the protective arms 124 and 126 from the closed position shown in FIG. 10 to the open position shown in FIG. 12. In FIG. 12, a user's fingers are shown pressing against fingers 150 and 152, holding the protective arms 124 and 126 in the open position. In the disclosed embodiment, the arms 124 and 126 are integrally formed with connector body 122, with a resilient hinge or stress member 148 joining them. The hinge 148 is sufficiently resilient to force against the protective arms 124 and 126 to spring them from the open position shown in FIG. 12 to the normally closed position shown in FIG. 10. With reference to FIG. 12 A and FIG. 13, the sheath 120 is illustrated as two nearly identical halves shown generally at 154 and 156 which can be folded about a resilient portion 158 to form the sheath 120 as illustrated in FIG. 10. The resilient portion 158 is illustrated extending the length of the connector body 120 (see FIG. 13). It should be appreciated that portion 158 could be much shorter and still connect the halves 154 and 156. It is within the scope of the invention to not even provide portion 158 altogether. If excluded, the two halves would then need to be joined along the four free edges as opposed to the two free edges 160 and 162. Although the Applicant does not believe it would be as desirable, it would still function properly. The free edges 160 and 162 of the connector body 120, as illustrated in FIGS. 12 A and 13, include a locking means for locking the two halves 154 and 152 together. In the disclosed embodiment, the locking means is a male protrusion 164 and a female opening 166. The female opening 166 has a reduced diameter opening such that the male protrusion 164 can be snapped into it and retained. In the disclosed embodiment, the male protrusion 164 extends the length of the free edge 160, and the female opening 166 extends the length of free edge 162. It should be appreciated that the length of the locking means could be much less, or in the alternative, more than one male protrusion 164 and female opening 166 could be used. In use, the two halves 154 and 156 can be folded over portion 158, and the male protrusion 164 snapped into female opening 166 to lock the two halves together. Once the two halves are snapped together, the connector body 122 is formed and can be slipped over the syringe 12. Additional locking means could be used. For example, the locking means could be an adhesive to adhere the free edges 160 and 162 together. Another method to lock the connector body 122 together would be to use a shrink wrap material to shrink about the connector body 122 and lock the free edges 160 and 162 together. With reference to FIG. 14, a further embodiment of the sheath of the present invention is illustrated generally at 170. As in the previous embodiment, the sheath 170 is formed in two halves. In the illustrated embodiment, the sheath 170 has a single protective arm 172 and a single finger 174. The protective arm 172 is interconnected to the connector body 122 by a resilient hinge or stress member 175. As can be seen in FIG. 18, the single protective arm 172 can be rotated to expose the needle 18 by grasping the syringe, preferably at the connector body 122 and the finger 174 and thereafter squeeze the finger 174 against the connector body 122. The movement of the protective arm 172 is illustrated in FIGS. 16 and 18. The sheath 170 is illustrated with four sides--176, 178, 180, 182, and a bottom 183. The side 176 has a slot 185 for ingress and egress of the needle 18. As should be appreciated, the slot 185 is slightly wider than the maximum diameter of needle 18 to allow free movement of the sheath 170 about needle 18. This configuration of sheath 170 completely encompasses the needle in the normally closed position to prevent inadvertent punctures. As in all the previous embodiments, the protective arm 172 is normally in the position shown in solid lines in FIG. 16 and must be biased against stress member 175 to the position illustrated in phantom lines in FIG. 16. Stress member 175 will normally bias and force protective arm 172 back to the normal closed position. To provide additional protection, the protective arm 172 includes an entrapment door 184 to resist movement of the protective arm 170 from the closed position to the open position. The entrapment door 184 is illustrated with two doors 186 and 188. The doors are approximately .015 inches in thickness and are secured to the side 176 by resilient hinges or stress points 190 and 192. As illustrated in FIG. 17, the doors 186 and 188 are normally biased inwardly and in the preferred embodiment, at about 10 degrees to the side 176. The resilient hinges or stress points 190 and 192 allow the doors 186 and 188 to open as a result of the force of the needle 18 acting on the doors 186 and 188 as protective arm 172 is urged to the open position. The inward angle of the doors results in the need for very little force to open the doors 186 and 188 inwardly, to allow the protective arm to conceal needle 18, but results in the need for much greater force to expose the needle 18. In this way, the protective arm 172 is urged by little relative force to the normal closed position, and the doors 186 and 188 do not interfere with the protective arm 172 returning to the normally closed position about needle 18. However, the force required to open the doors, due to the bias, is a greater relative force to present inadvertent exposure of the needle 18. As can be seen in FIGS. 14 and 15, the sheath 170 is formed in two halves which are joined along line 194. In the preferred embodiment, the connector body 122 is joined along line 194, and the protective arm is joined along line 194 by a stress point or living hinge. In this way, the two halves can be folded along line 194, and the free edges 199 connected to form the protective sheath 170, as illustrated in FIG. 1. The free edges can be attached in the same manner as the free edges of protective sheath 120. It should be appreciated that in this embodiment, the free edges 199 could be joined either along the connector body 122, the protective sheath 172, or both. With reference to FIG. 19, a further embodiment of a resilient hinge 200 is illustrated. It is within the intended scope of the present invention that the hinge 200 could be used in any one of the various embodiments of the present invention. The hinge 200 includes a plurality of ridges and grooves that facilitate the ability to move the protective arms 202 and 204 from the normal closed position to the open position. Additionally, the hinge 200 facilitates the rapid return or snapping back of the protective arms 202 and 204. The ridges and grooves allow for a thicker area to increase the snap back at the hinge 200 without increasing the resistance to movement of the protective arms 202 and 204 to the open position. With reference to FIGS. 20 through 22, a further method for locking the protective arm in the closed position is illustrated. In this embodiment, an articulated locking bar 220 is illustrated. In the preferred embodiment, the articulated locking bar 220 is integrally joined at 222 to the connector body 122. The bar 220 is illustrated having an opening 224, which is interference fit to a tab on the finger 226. It should be appreciated that bar 220 could be integrally joined to finger 226 instead of being interference fit. The bar 220 includes a hinge 228, allowing the bar to articulate. In the preferred embodiment, the hinge 228 is formed by forming a slot wedge-shaped recess in the bar 220. As can be seen in FIG. 22, the bar can be folded against the connector body 122 as the finger 226 is urged against connector body 122. This is illustrated by the phantom lines. In the normal position, the bar 220 is fully extended as illustrated by the solid lines. In operation, the user presses inwardly against the hinge 228 to bend the bar 220 inwardly, while simultaneously pressing finger 226 in the direction of connector body 122. In the alternative, the bar 220 could be connected to finger grip 226 so that movement of finger 226 toward connector body 122 will automatically bend bar 220 at hinge 228 so that hinge 228 does not have to be pressed. As shown in phantom lines in FIG. 22, the bar 220 folds in half against the connector body 122. As long as the finger 226 is held by the user against the living resilient hinge 230, the needle remains exposed. Upon releasing pressure on finger 226, the living resilient hinge 230 will cause the protective arm 232 to snap back to its normally closed position, concealing the needle 18. In addition, the bar 220 is preloaded due to its being folded against living resilient hinge 228 and will provide additional force to the protective arm 232 to force it back to the bar's normal closed position. When fully extended, as shown in FIG. 22, the locking bar 220 acts as a lock to lock the protective arm 232 in its normally closed position. With reference to FIG. 20, a pocket 234 is provided on the protective arm 232. As those of ordinary skill in the art will appreciate, the pocket could be used on any of the foregoing embodiments and, in particular, on the single arm sheaths. In the preferred embodiment, the pocket 234 has a back wall 236 and side walls 238. The back 236 and walls 238 are inclined outwardly from about midway on the side 240 of the protective arm 232 to about the end 242 of the protective arm 232. The pocket 234 receives the needle 18, allowing the protective arm 232 to be inclined at approximately 5 degrees with respect to the longitudinal center line of the needle 18. Depending on the depth and inclination of the pocket 234, various inclinations of the protective arm 232 can be obtained. One advantage of the pocket 234 is the additional concealment of the needle 18. An additional advantage is the ability to preload the resilient hinge 230 to the normally closed position. The preloading of the hinge 230 results in a thinner hinge 230. With a thinner hinge 230, the force required to expose the needle 18 is reduced, thereby enhancing the tactiles of the protective sheath. However, even with a thinner hinge 230, the snap back of the protective arm 232 is not adversely affected due to the preload of hinge 230. The optimal thickness of the preloaded hinge 230 would be determined by tests comparing various pocket inclinations to various hinge thicknesses and their relative snap-back force and tactiles. In FIG. 23, a modified coupling 243 is illustrated. The coupling 243 is illustrated with a pair of tabs or hooks 244 that snap together to couple the two halves of the protective arm together. With reference once again to FIGS. 20 through 22, the sheath is illustrated with a modified connector body 122. The connector body 122 of this embodiment is semi-circular in cross-section as illustrated in FIG. 21. The connector body 122 is intended to be snap fit onto the syringe in the same manner as the connector body in each of the previous embodiments. By only using one-half of the connector body, the connector body of this embodiment reduces material costs and, in turn, reduces the cost of the sheath. Although it is intended that this connector body 122 can be snap fit onto the syringe, it may be necessary to add an adhesive between the connector body and the syringe to ensure that the connector body remains secured to the syringe during its movement between the opened and closed positions. Referring now to FIGS. 24 to 28, a further embodiment of the sheath of the present invention is illustrated generally at 250. The sheath 250 is connected to a syringe 12 and includes a protective arm 252, a connector body 122, and a control finger 254. In FIG. 24, the sheath 250 is shown in bold lines in its normally closed position and in phantom lines in its open position. With reference to FIG. 26, the slot 256 is shown at an angle to the longitudinal centerline of the needle 18, which is shown partially in phantom. In this embodiment, the angle of the slot 256 protects against inadvertent exposure of the needle 18. To expose the needle 18, the sheath 252 must be twisted with respect to the longitudinal center line of needle 18, as well as being rotated about an axis generally perpendicular to the longitudinal center line of the needle 18. This twisting and rotating action will result in the slot 256 being aligned with the needle 18 and allow the needle 18 to pass through the slot. There is an additional advantage to the protective arm 252 having an angled slot 256. Due to the twisting and rotating action, the resilient hinge 258 is twisted, as well as being bent back, which provides greater biasing action to snap the protective arm 252 back to the normally closed position. Since the hinge 258 is resilient, it has a memory and snaps the protective arm back along the same path of travel that the protective arm 252 traveled from the normally closed position to the open position. In this way, the needle 18 can easily pass back through the slot 256 when the pressure on protective arm 252 is released. To obtain the necessary twisting and rotating action, the disclosed embodiment shows the finger 254 angled with respect to a line generally perpendicular to the longitudinal center line of the needle 18. See FIG. 28. Due to the angle, as the finger is pulled back against the connector body 122, the protective arm 252 will be twisted and rotated. The degree of the angle will be determined by the angle of the slot with respect to the longitudinal center line of the needle 18. In addition to the finger 254 being angled, the twisting action is also facilitated by the width and position of the resilient hinge 258 and the thickness of the hinge 258. The width and position can be selected such that the hinge is offset with respect to the longitudinal center line of the needle 18. As should be appreciated by those of ordinary skill in the art, with the hinge 258 being off center, the movement of the protective arm 252 will be forced into a twisting action. The location and width would be determined by trial and error depending upon the material and its thickness, as well as the angle of slot 256. Although not preferred, the twisting action could also be obtained by varying the thickness of the hinge 258. Although the present invention has been described in detail with reference only to the presently preferred embodiments, it will be appreciated by those of ordinary skill in the an that various modifications can be made without departing from the invention. Accordingly, the invention is to be limited only by the following claims.

1a

RELATED APPLICATIONS The present application is a continuation application of U.S. patent application Ser. No. 12/633,057, filed Dec. 8, 2009, entitled “TEAR FILM MEASUREMENT,” which is a continuation of U.S. patent application Ser. No. 11/820,664, filed Jun. 20, 2007, issued as U.S. Pat. No. 7,758,190, entitled “TEAR FILM MEASUREMENT,” both of which are incorporated herein by reference in their entireties. The present application is also related to U.S. patent application Ser. No. 11/900,314, filed Sep. 11, 2007, entitled “TEAR FILM MEASUREMENT,” which is incorporated herein by reference in its entirety. FIELD This invention relates generally to the field of measurement of the tear film thickness on the precorneal surface of the eye and more particularly, to the measurement of the thickness of the outermost layer of the tear film, i.e., the lipid layer. BACKGROUND The human precorneal tear film is comprised of three primary layers, each of which serves a specific function. The innermost layer of the precorneal tear film provides a protective environment for the superficial epithelial cells of the cornea and helps protect against microbes and foreign bodies. The outer surface of the precorneal tear film is the primary refracting surface of the eye. Its surface tension helps to smooth this surface, thus improving the optical quality of the image ultimately impacting the retina. Additionally, the precorneal tear film provides a lubricating function during blinking. These structures are often disrupted in dry eye conditions, which are some of the most common ophthalmic disorders seen by eye-care practitioners. Dry eye disorders and/or disease can lead to premature breakup of the tear film after a blink, leading to damage of the superficial epithelium which may result in discomfort and be manifested as optical blur. In addition, the ability of a patient to wear contact lenses is a direct function of the quality and quantity of the tear film, and dry eye disorders and/or disease therefore has a significant impact on contact lens wear parameters. The precorneal tear film is comprised of an inner mucin layer, a middle aqueous layer, and an outermost thin lipid layer. Various treatments are used in an attempt to alleviate dry eye symptoms. For example, it has been proposed to treat certain dry eye conditions by the application of heat and pressure to unclog meibomian glands, or with pharmaceutical methods to unclog meibomian gland and to stimulate tear production. Notwithstanding the foregoing, it has been a long standing and vexing problem for clinicians and scientists to objectively demonstrate an improvement in the precorneal tear film thickness at the conclusion of the proposed treatment. Further, many promising treatments for dry eye have failed to receive approval from the United States Food and Drug Administration due to the inability to demonstrate clinical effectiveness to the satisfaction of the agency. In response to the foregoing long felt need, various methods of measuring the thickness of the precorneal tear film, and specifically the lipid layer thereof have been proposed. For example, Korb, one of the inventors of this invention provided an overview and background of his invention of a specular reflection microscope system that allowed quantification of the tear film lipid layer thickness based on the interference colors of the lipid layer. This system included a hemi-cylindrical broad spectrum illumination source with heat absorbing filters, a binocular microscope with a Zeiss beam-splitter providing 70% light to a high resolution video camera, a VHS recorder, and a high resolution 20-inch color monitor. Following calibration with Eastman Kodak color reference standards (Wratten filters), the static and dynamic appearance of the lipid layer was observed before and after blinking. During the observation period, the subject was instructed to blink naturally while gazing at a fixation target. For purposes of quantization and standardization, a specific region of the tear film was designated for analysis. This area encompassed a zone approximately one mm above the lower meniscus to slightly below the inferior pupillary margin, averaging 7-8 mm wide and 2.5 mm in height. The dominant color of the specularly reflected light within this designated area was used as the basis for assigning lipid layer thickness values. Thickness values were assigned to specific colors on the basis of prior work on tear film lipid layer interference colors (McDonald, 1969; Nom.; 1979; Guilon, 1982; Hamano et al., 1982) and are summarized in Table 1. To confirm the lipid layer thickness values assigned to each subject's tear film lipid layer, recordings were independently graded by two observers masked as to subject identity. (Korb, D R, Baron D F, Herman J P, et al., Tear Film Lipid Layer Thickness as a Function of Blinking, Cornea 1994:13:354-9). While the foregoing apparatus was effective in measuring improved lipid layer thickness, measurement inaccuracies were nevertheless introduced into the system. Working backwards, the color monitor had to be provided with a sufficient input signal to enable the lipid layer to be imaged on to the monitor screen. The foregoing thus required a minimum illumination to be provided to the slit lamp, of which 70% was directed to the high resolution video camera. This, in turn, dictated the minimum amount of light required to illuminate the corneal surface. Thus, the amount of light required to make the foregoing system operational was not optimum as it interfered with the naturally occurring tear film as the heat generated by the light caused tear film evaporation. Further, the amount of light required to make the system functional caused some degree of reflex tearing. Another apparatus for measuring the tear film is disclosed in European Patent Application EP 0 943 288 assigned to Kowa Company, Ltd. of Japan. The application discloses an apparatus for the non-contact measurement of the quantity of lacrimal fluid collected on the lower eyelid. According to the invention, tear volume is calculated from a measurement of the volume of fluid pooled at the lid eye meniscus. While knowledge of the total volume of fluid may be of some use to eye-care practitioners, it does not specifically measure the lipid layer thickness or its improvement as the result of a particular treatment regimen. U.S. Pat. No. 4,747,683 to Marshall G. Doane discloses a Method and Device for in Vivo Wetting Determinations wherein a contact lens is illuminated with coherent light and the pre-lens tear film is imaged in such a way as to form an interference pattern. The image formed thereby is recorded and the tear film thickness is determined by correlating the interference bands of the recorded image. A coherent light source and a camera are focused at the pre-lens film to image specularly reflected light from the front and rear surfaces of the tear film. A film motion analyzer provides numerical coordinates of interference bands, and a microprocessor analyses the coordinates to provide a quantitative measure of lens position or wetting characteristics. Again, while knowledge of the tear film thickness covering the contact lens surface may be useful in the context of contact lens fitting, the Doane apparatus does not specifically measure lipid layer thickness on the natural eye. Another instrument that purports to measure tear film lipid layer thickness is the Tearscope Plus manufactured by Keeler Instruments Inc., of Broomall, Pa. and Berkshire, UK. More specifically, the Tearscope is a hand-held or slit lamp mounted device that comprises a tubular housing which contains a coaxially mounted cylindrical light source. The interior bore of the housing is covered with a cylindrical diffuser plate that diffuses the light. In use, the eye-care practitioner places one end of the tube proximate the patient's eye thus illuminating the whole eye, including the pupil, and observes the interference patterns on the pupil surface through the opposite end of the tube. The color of the interference pattern generated by blinking is then correlated to tear film thickness. The Tearscope is not without its inherent drawbacks and deficiencies as the process by which the eye is illuminated and the measurement is made introduces error which is diagnostically unacceptable. For example, the proximity of the illuminator to the eye surface when combined with the light intensity required to obtain a viewable interference pattern can cause reflex tearing. In addition, the illumination system employed illuminates the entire eye, including the pupil. Thus, light from the Tearscope is directed on to the retinal surface which, in turn causes a proprioceptive response which also skews measurement accuracy. In view of the foregoing, it is an object of the present invention to provide a method and apparatus that overcomes the drawbacks and deficiencies of the prior art. Another object of the present invention is to provide a method and apparatus that allows the accurate measurement of the thickness of the lipid layer component of the precorneal tear film. A further object of the present invention is to provide a method and apparatus wherein the lipid layer thickness of the precorneal tear film may be measured without the introduction of reflex tearing. A still further object of the present invention is to provide a method and apparatus that enhances contract and thereby the observability and measurability of the lipid layer thickness of the precorneal tear film. Yet another object of the present invention is to provide a method and apparatus for measuring the lipid layer thickness of the precorneal tear film using a low level of light in order to minimize tear film evaporation that can alter the measurement. Another object of the present invention is to provide a method and apparatus for measuring the lipid layer thickness of the precorneal tear film wherein the patient is comfortable during the examination. Another object of the present invention is to provide a method and apparatus for measuring the lipid layer thickness of the precorneal tear film that minimizes light entering the pupil to minimize reflex tearing and proprioceptive responses that can alter the measurement. SUMMARY OF CERTAIN EMBODIMENTS In accordance with the foregoing, the invention comprises an apparatus for measuring the thickness of the lipid layer component of the precorneal tear film on the surface of an eye after distribution of the lipid layer subsequent to blinking. An illuminator directs light to the lipid layer of a patient's eye. A means for observing the specularly reflected light rays is provided. The illuminator is a broad spectrum, large area lambertian light source covering the visible region, the rays of which are specularly reflected from the lipid layer and undergo constructive and destructive interference in the lipid layer. A collector such as a camera or slit lamp may be provided to collect and focus the specularly reflected light such that the interference patterns on the tear film lipid layer are observable. The collector also produces an output signal representative of the specularly reflected light which is suitable for further analysis, such as projection on to a high resolution video monitor or analysis by or storage in a computer. Alternatively, the interference patterns of the specularly reflected light may be directly observed by the clinician and recorded. In order to facilitate ease of measurement, the patient's head may be positioned on an observation platform, for example, a slit lamp stand, when the illuminator directs light to the lipid layer of the patient's eye. In a first embodiment of the invention, the illuminator is sized to show the interference pattern of the lipid layer over the whole eye, (termed herein the “whole eye illuminator”), with the provision that the intensity of the light entering the pupil and striking the retina are below the threshold at which appreciable measurement error is introduced, i.e., the reflex tear and proprioceptive responses are not activated. Observation of the interference pattern in the preferred embodiment is through an opening in the illuminator. In a second embodiment of the invention, the illuminator is sized to show the interference pattern of the lipid layer below the pupil, (termed herein the “half eye illuminator”), such that the intensity of the light entering the pupil is extremely low, thus avoiding the introduction of virtually all system-induced inaccuracy. Observation of the interference pattern in this second embodiment is from above the illuminator. BRIEF DESCRIPTION OF THE DRAWINGS These and other features will be understood with reference to the figures, in which FIG. 1 is a side view of the tear film analyzer according to the present invention mounted to a stand with a patient positioned for viewing of interference fringes on the lipid layer of the eye. The illuminator portion is shown as a vertical cross section through the center. FIG. 2 is a plan view of the tear film analyzer according to the present invention mounted to a stand with a patient positioned for viewing of interference fringes on the lipid layer of the eye. FIG. 3 a is a side view of a second embodiment of the tear film analyzer according to the present invention mounted to a stand with a patient positioned for viewing of interference fringes on the lipid layer of the eye. The illuminator portion is shown as a vertical cross section through the center. FIG. 3 b is a side view of the second embodiment of the tear film analyzer according to the present invention mounted to a stand and tilted with a patient positioned for viewing of interference fringes on the lipid layer of the eye. The illuminator portion is shown as a vertical cross section through the center. FIG. 4 a is a plan view of the second embodiment of the tear film analyzer according to the present invention mounted to a stand with a patient positioned for viewing of interference fringes on the lipid layer of the eye. FIG. 4 b is a plan view of the second embodiment of the tear film analyzer according to the present invention mounted to a stand and tilted with a patient positioned for view of interference fringes on the lipid layer of the eye. FIG. 5 a is a plan view of the second embodiment of the tear film analyzer according to the present invention illustrating the illuminator surface that produces the outer edges of the viewable area of interference fringes. FIG. 5 b is a side view of the second embodiment of the tear film analyzer according to the present invention illustrating the illuminator surface positioned below the plane of the pupil and tilted at an angle and showing the outer edges of the viewable area of interference fringes. FIG. 5 c is a side view of the second embodiment of the tear film analyzer according to the present invention illustrating the illuminator surface vertically positioned below the plane of the pupil and showing the outer edges of the viewable area of interference fringes. FIG. 6 is a perspective view, partially exploded, of the full eye illuminator according to the present invention. FIG. 7 is a plan view, sectioned horizontally through the center of the viewing hole of the full eye illuminator according to the present invention. FIG. 8 is an end view, sectioned vertically through the center of the full eye illuminator according to the present invention. FIG. 9 is a perspective view, partially exploded of the half eye illuminator according to the present invention. FIG. 10 is a plan view with the top removed of the half eye illuminator according to the present invention. FIG. 11 is an end view, sectioned vertically through the center of the half eye illuminator according to the present invention. FIG. 12 is a front view of the surface of an eye and illustrating schematically the area defined by the extreme lambertion rays wherein interference patterns are viewable. DETAILED DESCRIPTION While the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which particular embodiments are shown, it is to be understood at the outset that persons skilled in the art may modify the invention herein described while still achieving the favorable results of this invention. Accordingly, the description which follows it to be understood as a broad teaching disclosure directed to persons of skill in the appropriate arts and not as limiting upon the present invention. In a first embodiment best shown in FIGS. 1 , 2 and 6 - 8 , referred to herein as the “full eye illuminator” the apparatus according to the present invention broadly comprises an illumination means 100 and a means for observing the specularly reflected light 200 . A second embodiment best shown in FIGS. 3 a , 3 b , 5 a - 5 c and 9 - 11 , referred to herein as the “half eye” illuminator is shown. The mode of operation of the two embodiments is substantially identical and they will therefore be described together using the same reference numerals and where differences between the embodiments occur, they will be discussed. The illumination means 100 for directing light to the lipid layer of the patient's eye comprises a large area broad spectrum light source covering the visible region and being a lambertian emitter adapted to be positioned in front of the eye on a stand 300 . As employed herein the terms “lambertion surface” and “lambertian emitter” are defined to be a light emitter having equal intensity in all directions. The light source comprises a large surface area emitter, arranged such that rays emitted from the emitter are specularly reflected from the lipid layer and undergo constructive and destructive interference in the lipid layer. An image of this surface is the backdrop over which the interference image is seen and it should be as spatially uniform as possible. The illumination means 100 illuminates a large area of the face which creates a 2.5 mm high by 5 mm long viewable area centered beneath the pupil 310 (see FIG. 12 ) which is adequate for lipid layer thickness determination and correlation to dry eye. By “viewable area” it is meant the active area that satisfies the criteria for viewing interferences fringes; i.e., approximately 2.5 mm×7 mm for the half eye illuminator. Full-eye illumination, excluding the pupil area, reveals additional information about the whole eye pattern of lipid distribution. The geometry of the illuminator 100 can be most easily understood by starting from the camera lens and proceeding forward to the eye and then to the illuminator. The fundamental equation for tracing ray lines is Snell's law: N 1 Sin θ 1 =N 2 Sin θ 2 ,  1) where N is the refractive index of the medium containing the ray, and θ=the angle of the ray relative to the normal from the surface. For a reflected ray that doesn't enter the lipid layer, N 1 =N 2 , and θ 1 =θ 2 .  2) Under these conditions, Snell's law reduces to the classical “angle of incidence is equal to the angle of reflectance” statement. According to the present invention, it is necessary to determine only the extreme rays (the ones at the outermost boundary of the desired viewing area) to define the area of the illuminator. Since the surface of that portion of the eye to be examined is approximately spherical, a line drawn from the camera lens (or the observer's eye) to the edge of the viewing area on the observed eye will reflect at the same angle on the other side of the line normal to the eye surface at the point of intersection of the line with the eye. When the half eye illuminator used, it may be tilted to better accommodate the nose and illuminate a larger area of the inferior lipid layer. Notwithstanding the foregoing, experimentation using the half eye illuminator has shown that a tilt of 10° to as much as 30° is still functional. Returning now to the full eye illuminator, as best shown in FIGS. 1 and 2 , it will be seen that facial features block some rays from reaching the surface of the eye. The nose, cheeks, eyebrows, and eyelids block rays, causing shadows on the eye surface. Positioning the illuminator for maximum area exposure is unique to each patient's facial structure. The mechanical dimensions (height and width) of the illuminator may be extended to cover the biometric range of facial features of the target population. The illumination means 100 is a broad spectrum light source covering the visible region between about 400 nm to about 700 nm. In the model that was constructed, high efficiency, white Light Emitting Diodes (“LEDs”) 120 were used that have a 50° forward projection angle, 2500 mcd typical intensity, and 5 mm diameter (part number NSPW510CS, available from Nichia Corporation, Wixom, Mich.). Other LEDs could be added to the present invention to enhance the spectral width in the near UV or near IR regions. The light emitting array platform 130 ( FIGS. 6 , 7 ) into which the LEDs are mounted had a curved surface, subtending an arc of approximately 130° from the optical axis of the eye (see FIG. 5 a ). Approximately 96 LEDs spaced apart in a grid pattern with 6 rows and 16 columns were connected in parallel/series combinations and connected to an appropriate power supply, well known to those skilled in the art and therefore, not shown. A housing is formed around the LED array platform 130 by a pair of side panels 135 , bottom and top panels 140 , rear panel 145 and the diffuser means or diffuser 150 . The respective diffuser 150 , LED platform 130 , and rear panel 145 are flexible and fit within grooves 147 located in the top and bottom panels 140 and the end pieces 135 . The entire assembly is snapped together and the side panels 135 are then screwed to top and bottom panels 140 . While the illumination means 100 illustrated in the figures is curved or arcuate and has a radius of 7.620 inches from the center of the eye under examination, it could be flat as long as it subtends 130° around the eye. A curved surface is more efficient in doing this, as the geometry yields a smaller device which is easier for the practitioner to use in a clinical setting. The total power radiated from the illuminator 100 must be kept to a minimum to prevent accelerated tear evaporation. In addition, air currents generated by heating or cooling systems can also cause excess evaporation and must be minimized (preferably eliminated) to maintain measurement accuracy. The brightness, or intensity, measured in μW/mm 2 , entering the pupil can cause reflex tearing, squinting, and other visual discomforts, all of which affect measurement accuracy. For a full-eye illuminator, the curved lambertian emitter includes a centrally positioned hole defining an opening 160 through which the means for collecting and focusing the specularly reflected light, i.e., a camera, eye, or other lens 200 , is positioned. The opening 160 in the center substantially prevents direct illumination from entering the pupil of the test eye. While less than optimal, the opening 160 could be located in other parts of the illuminator. The other eye, however, has the full light intensity entering the pupil. If the illumination intensity is low enough, the exposed eye does not react. The exposed eye may also be occluded with a mask, or the illuminator may be segmented so that parts of the surface are not illuminated. The half-eye illuminator stops below the centerline of the eye and does not directly illuminate either pupil or stated otherwise, light rays can only enter the pupil obliquely and do not impinge on the retina. The current full-eye illuminator has a brightness or illumination intensity of between about 3 μW/mm 2 and 15 μW/mm 2 with about 4.5 μW/mm 2 at the surface of the illuminator being preferred, which is held 1-2 inches from the eye. The total radiated power is less than 1 W and preferably no more than 400 mW. Brightness above about 6 μW/mm 2 becomes uncomfortable to the second eye if it enters the pupil so as to impinge directly on the retina. The front surface of the illuminator is the lambertian emitter, i.e., all points on the extended illuminator surface are lambertian emitters, and comprises a flexible white translucent acrylic plastic sheet 150 approximately 1/16 inch thick that serves the function of diffusing the light emitted from a plurality of LED point sources and transforming them into the uniform Lambertian emitter In order to prevent alteration of the proprioceptive senses and reduce heating of the tear film, it is important to minimize the incident power and intensity on the eye and thus, the means for collecting and for focusing the specularly reflected light such as a high sensitivity color camera 200 should be employed. The video camera, slit lamp or other observation apparatus 200 is positioned in opening 160 and is also mounted on stand 300 as shown in FIG. 2 or in the case of the half eye illuminator positioned above the emitter as per FIGS. 3 a and 3 b . Detailed visualization of the image patterns requires a means for collecting the specularly reflected light and for focusing the specularly reflected light such that the interference patterns from the lipid layer are observable. Good digital imaging requires a CCD video camera having a resolution of up to 1280×1024 pixels and at least 15 Hz frame rate to show the progression of lipid interference patterns as they spread across the eye. The AVT Dolphin 145C, ⅔ inch, CCD camera with 6.45 μm 2 pixels meets the requirements and outputs a signal representative thereof which may serve as the input signal to any one of a number of devices such as a video monitor (preferably high resolution) or a computer for analysis and/or archiving purposes. The lens system employed in the instant tear film analyzer images a 15-40 mm dimension in the sample plane (the eye) onto the active area of the CCD detector (e.g.about. 10 mm horizontal dimension for a ⅔ in. CCD). The lens f-number should be as low as practical to capture maximum light and minimize the illumination power needed for a good image. The lens chosen for the half-eye and full-eye systems is the Navitar Zoom 7000 close focus zoom lens for ⅔ in. format CCDs. At lower magnification (25-40 mm field of view), the eye and lids can be examined to observe the relationship of the blink to the lipid layer thickness. A more detailed analysis of the lipid layer can be obtained with a slightly higher magnification showing a 15-25 mm field of view. The lipid layer thickness is not uniform and is classified on the basis of the most dominant color present in the interference pattern. It is believed that the lipid layer for most individuals cannot exceed 180 nm, and since thicker lipid layers provide better protection from evaporation than thinner lipid layers, thicker lipid layers provide greater protection against the development of dry eye states. Thinner lipid layers are associated with dry eye states and dry eye symptoms, particularly if the lipid layer thickness is less than 75 nm. The present system displays the interference patterns from white light incident on the lipid layer film. The relation between the colors of the interference pattern and the lipid layer thickness (LLT) are shown in Table 1. TABLE 1 LIPID LAYER Letter Color THICKNESS (nm) Grade Blue 180 A Blue/Brown 165 A− Brown/Blue 150 B+ Brown 135 B Brown/Yellow 120 B− Yellow/Brown 105 C+ Yellow  90 C Grey/Yellow  75 C− Grey  60 D+ Grey/White  45 D White  30 F Extensive research has established that thicker films are indicated by a blue and brown color, mid-thickness films are indicated by a yellow color, thinner films are indicated by a grey-yellow color, and very thin films exhibit a gray scale of different densities with white representing the thinnest. It is believed in color photometry, brown can be obtained in an additive process by mixing small intensities of red and green, or orange and blue, basically the opposite ends of the visible light spectrum. Alternatively, brown can be obtained in a subtractive process by filtering out the central yellow-green colors from the white spectrum, leaving a blue-orange mix. It has not been verified why the wavelengths of light observed in the interference film are inverse to the film thickness, but extensive clinical testing has led the inventors to the belief and the theory that destructive interference is the dominant process. The closer the wavelength is to the film thickness, the greater the interference, so yellow-red interference will have the strongest effect in a thicker film. However, thicker films appear blue, so it is postulated that red wavelengths are removed from the incident light spectrum by destructive interference and the reflected light appears blue. For a thinner film, blue will have a stronger interference. Since the thinner films appear reddish, it is assumed that the blue is removed by destructive interference. From this, we assume that the color seen is the broadband surface reflection with the dominant interference color band removed. That is, interference subtracts the portion of the spectrum indicative of the film thickness from the reflected light, leaving the complementary colors. This is the best explanation known to the inventors of how brown is obtained from a system of this type. Table 1 lists the colors of the visible spectrum and their respective wavelengths. It must be noted that the thickness of the lipid layer on the eye is much smaller than all the wavelengths of visible light. Therefore, full wavelength interference patterns are believed not to be possible. For fractional wavelengths, (λ/2n, n=1, 2 . . . ) the intensity in the interference pattern decreases rapidly as n increases and the ability to differentiate weak interference patterns from the background decreases accordingly. When the lipid film thickness falls below about 90 nm, no color is seen in the image generated by the present apparatus (employing the current LED light source), only gray of varying density. It is presumed that violet and ultraviolet interference effects predominate at this thickness, but since they are absent from the incident spectrum, no color can be seen. Any interference remaining over the visible light spectrum is so weak due to the very small fraction (λ/2n, n>5) that full-spectrum reflection and absorption effects dominate and no particular color can be seen. Broadband destructive interference in the 60-75 nm layers gives way to broadband constructive interference at the thinnest layer (<=30 nm). In summary, it is believed that the present invention demonstrates the results of subtractive colors, where subtracting the blue end from white light leaves a reddish tint, subtracting the center (yellow-green) from the spectrum leaves a brownish tint, and subtracting orange-red leaves a blue tint. Because all the interference patterns are fractional wavelengths, and therefore relatively weak in intensity, the images are not strongly saturated. Image enhancement techniques therefore assume a higher importance for good visibility. Film thickness below about 90 nm can be determined by gray scale analysis. Should the use of real time or high speed data transfer and large storage volumes be required for a given application, the use of a means for recording the output signal representative of the specularly reflected light (video output signal) such as a high performance computer system would be needed. As employed herein, the term “real time” is defined as data transfer, storage and retrieval at a rate required for image generation that the observer requires for a subjectively satisfactory viewing experience. For viewing the motion of the lipid layer interference pattern after blinking a minimum of about 15 frames per second is satisfactory for seamless motion perception. Depending upon settings, the camera can create 1.4-3.9 MB images at 15 per second, or 21-57 MB/sec which must be processed by the computer for storage, display, or computation. At this rate, one minute of recording requires 1.26-3.42 GB of storage. Given the presently available technology, it is not reasonable to store recording sessions in RAM, so the data from the camera must be streamed directly to a storage system sized to meet the anticipated volume of data. For example, 500 GB of storage could record 147-397 tests of one minute duration. Various forms of data management could be applied to reduce the storage requirements, including image size, compression, and minimizing recording time adequate to good diagnostics. The software to operate the camera, capture the images, store and retrieve image files, and execute chosen calculations on the data is critical to the success of the system. Relevant specifications are: The mechanical system consists of components to position the patient's head, position the illuminator and camera, focus the camera, and switch position between eyes. Current ophthalmic chin rests are adequate for positioning and restraining the head. They include vertical (Z axis) adjustment. A movable frame positions the camera and illuminator opposite the patient's face. The illuminator and camera move together in a gross manner, but the illuminator has an independent X and rotational motions for accommodating different facial geometries. Switching from eye to eye requires moving the whole camera/illuminator frame away from the patients face (X motion) and horizontally to line up with the second eye (Y motion). Focusing the camera requires fine control of X motion, and vertical Z motion is required to accommodate differences in patient eye positions. A classical slit lamp biomicroscope stand incorporates most of these motions, and have added angular motions not needed in the present system. FIGS. 1 , 2 , 3 a - 3 c illustrate the full-eye system. A typical examination session proceeds as follows: Presets: The vertical relationship between the camera and the illuminator is set. For a half-eye illuminator, the camera position is just enough higher than the illuminator top edge that the image contains no edge effects. When using the full-eye illuminator, the camera is positioned coaxially with the hole through the illuminator. The camera/illuminator position should not need adjusting thereafter. Patient Examination: 1. The patient is seated and asked to place their chin on the chin rest. The chin rest is adjusted (Z axis) for the comfort of the patient. The patient is asked to hold their forehead against the forehead rest. 2. The frame holding the camera & illumination is positioned on the axis of the first eye and brought close enough for rough focus on the skin. 3. The frame is adjusted for vertical and horizontal centering, and then moved forward for fine focusing. 4. The illuminator is adjusted forward and back, and rotated for best illumination of the eye. Repeat fine focus as necessary. The patient is asked to look directly at the center or top center of the camera lens. Instructions are given to the patient for blinking regimens by the diagnostician. 5. The images are viewed and recorded as desired. 6. The frame may be pulled away from the patient (to clear the nose) and moved horizontally to the next eye. Steps 2-5 are repeated. The system could be fully motorized and operated in manual, semi-autonomous, or autonomous modes, depending upon the sophistication of the control software. A fully automatic system would adjust the mechanical stand, focus the camera, record the motion of the lipid film, calculate various measurements of the film structure, report an assessment of the quality of the lipid film, and record the data in the patient's record file. The invention having been thus disclosed, diverse changes and variation in the apparatus and method will occur to those skilled in the art, and all such changes and modifications are intended to be within the scope of the invention, as set forth in the following claims:

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This non-provisional application claims priority to U.S. Provisional Application Ser. No. 61/408,506 filed on Oct. 29, 2010, which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to a system and method for producing and storing freshly made baby food. [0004] 2. Description of Related Art [0005] Fresh and organic baby foods are not readily available in supermarkets today, nor it is easy or convenient for one to prepare and store homemade baby foods. Store-bought jarred baby food is commonly considered a convenient way to feed a growing baby. However, the jarred food is overly processed compared to the fresh produce that it is made from. For example, typical jarred baby food can have a shelf life of up to three years because it has been heated to extremely high temperatures that can kill bacteria. This large amount of heat applied can also have a negative effect on the nutrition of the food. Jarred food can also contain fillers, preservatives, additives, sweeteners, and even a certain level of acceptable “non-food” ingredients such as bug parts, rodent hairs, and rodent droppings, among other things. [0006] In addition, jarred food is more expensive than the amount of food that can be made from fresh produce. For example, jarred baby food can typically cost approximately one dollar per serving. On the other hand, one can produce, for example, approximately 10 servings of baby food from one organic sweet potato for the same price. One can also save time and money by making baby food at home rather than traveling to a grocery store. [0007] An alternative to buying baby food in the supermarket is making it at home. However, there is no simple and convenient system or method available to do so. Current methods of producing homemade baby food are wasteful. One may create a large quantity of baby food using a blender or food processor but lack an organized system to store the food in a manner that indicates the freshness level of the food. As a result, excess food may be thrown away. [0008] What is needed is a quick, more efficient, affordable, and convenient at-home system and method for producing and storing high quality, homemade blended foods. Also what is needed is a system that has an adjustable and reusable indicator to indicate the freshness level of the food. With these goals in mind, the inventor has created an easy-to-use and organized system and method for instantly making multiple days worth of fresh, homemade baby food having the aforementioned desired qualities. BRIEF SUMMARY OF THE INVENTION [0009] The present invention includes a system for enhancing preparation and storage of freshly homemade baby food. The system can include a blender base and a blender container having a removable blade adapter. The removable blade adapter has a blade member. The blender container and removable blade adapter are capable of operatively engaging with the blender base to thereby process food with the blade member when engaged. The blender container can further comprise at least one locking member to lock the blender container to the blender base and a lip extending around the perimeter of the blender container to prevent spills into the blender base. [0010] The system can also include at least one storage cup capable of receiving the food processed by the blender. The storage cup can have a removable lid and an indicator that can indicate the date the food was prepared, the date to use the food by, or other desired indicium. In one embodiment, the indicator can comprise a rotatable element having an indicator window through which a reference indicium is visible. [0011] The system can also include a cup storage tray having at least one receptacle. The receptacle is capable of holding a plurality of storage cups or blender containers. Another storage option of the system is a food storage tray having at least one cavity capable of receiving food processed by the blender. A storage tray cover can be provided to cover the food storage tray. A spatula may also be provided to transfer the processed food from the blender containers to other storage devices of the system. [0012] The system can also include multiple removable lids and sipper tops adapted to connect to an open end of the blender containers or storage cups. When the closed ends of the blender container or storage cups is rounded, the storage devices can further comprise at least one protruding element to allow the device to stand upright on a flat surface. The blender containers and storage cups can further comprise handles to allow better handling when used as drinking vessels. [0013] A method for enhanced preparation and storage of freshly produced food portions using the system is also described, generally comprising the following steps: processing food in the blender container; transferring the processed food to a storage cup or at least one cavity of said food storage tray; and covering the food storage device. When a storage cup or blender container having an indicator is used to store the food, a user can adjust the indicator to set the desired indicium. A user can easily pre-plan the preparation a known amount of food portions using the system and method. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0014] FIG. 1 is an embodiment of a system in accordance with the present invention; [0015] FIG. 2 is a perspective view of an embodiment of a blender container and blender base in accordance with the present invention; [0016] FIG. 3 is a perspective view of an embodiment of a blender base in accordance with the present invention; [0017] FIG. 4 is a top plan view of FIG. 3 ; [0018] FIG. 5 is a cross-sectional view taken along section line 5 - 5 of FIG. 4 ; [0019] FIG. 6 is a cross-sectional view taken along section line 6 - 6 of FIG. 5 ; [0020] FIG. 7 is a top perspective view of an embodiment of a removable blade adapter in accordance with the present invention; [0021] FIG. 8 is a perspective view of an embodiment of a blender container and removable blade adapter in accordance with the present invention; [0022] FIG. 9 is a bottom view of FIG. 8 ; [0023] FIG. 10 is a perspective view of an embodiment of a blender container and blender base in accordance with the present invention; [0024] FIG. 11 is a perspective view of an embodiment of a blender container in accordance with the present invention; [0025] FIG. 12 is a perspective view of an embodiment of a storage cup with an indicator and a removable lid attached in accordance with the present invention; [0026] FIG. 13 is a perspective view of an embodiment of a cup storage tray in accordance with the present invention; [0027] FIG. 14 is a perspective view of an embodiment of a food storage tray in accordance with the present invention; [0028] FIG. 15 is a perspective view of an embodiment of a food storage tray cover in accordance with the present invention; [0029] FIG. 16 is a perspective view of an embodiment of a spatula in accordance with the present invention; and [0030] FIG. 17 is a perspective view of an embodiment of a sipper top in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION [0031] The detailed description set forth below in connection with the appended drawings is intended to provide example embodiments of the present invention and is not intended to represent the only forms in which the invention may be constructed or utilized. The description sets forth the functions and the sequences of steps for constructing and operating the invention. However, it is to be understood that the same or equivalent functions and sequences may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. [0032] Some embodiments of the invention will be described in detail with reference to FIGS. 1-16 . Additional embodiments, features, and/or advantages of the invention will become apparent from the description or may be learned by practicing the invention. The drawings in the figures are not to scale and have like numerals referring to like features through both the drawings and the description. [0033] The system for enhanced preparation and storage of home-processed food portions can include a blender base 10 , at least one blender container 20 having a removable blade adapter 30 with a blade member 32 , a storage cup 40 with a removable lid 50 and a freshness indicator 60 , a cup storage tray 70 , a food storage tray 80 , a food storage tray cover 84 , a removable lid 50 adapted to fit the blender container 20 , and a spatula 110 . [0034] For the purposes of this invention, the term “blender” is generally defined as a device having whirling blades for chopping, mixing, blending, processing, or liquefying foods. Functionally, the blender base 10 has an electric motor 500 of the type generally known in the art to provide rotary motion to a blade 32 of the blade adapter 30 to process food in a blender container 20 . [0035] When the blender container 20 and removable blade adapter 30 are manufactured as one component or as separate components that are affixed with one another, the blade adapter 30 and blender container 20 can be operatively connected with the blender base 10 to process food in the blender container 20 . The blade member 32 is positioned within the blender container 20 during operation of the blender portion (i.e. the blender base 10 , the blender container 20 , and the removable blade adapter 30 ) of the system. [0036] An open end 22 of the blender container 20 may be coupled to a removable blade adapter 30 incorporating a blade member 32 adapted to agitate the contents of the container 20 . The blade member 32 is operatively coupled to an impeller 301 powered by a blender motor 500 of the type generally shown in FIG. 5 . The blade member 32 can include one, two, three, four or more cutting elements, as needed. The cutting elements can be generally flat members with sharpened edges, pointed tips, and/or one or more bends along the surface of the cutting elements. Different blade 32 embodiments may be suited for different foods. For example, a flatter blade 32 may be utilized to mill grains to make cereals. A cross-blade 32 that can be comprised of the flatter blade and a raised blade, as shown in FIG. 7 , can be utilized to puree and blend foods. [0037] The removable blade adapter 30 can be affixed to an open end 22 of the blender container 20 via a thread-fit, friction fit, snap-fit or any other suitable type of attachment. The open end 22 of the blender container 20 can also have at least one protruding locking member 26 , as generally shown in FIGS. 8 , 9 , and 11 . The locking members 26 are adapted to operatively lock blender container 20 to a blender base 10 of the type generally shown in FIGS. 2-4 and 10 . The locking members 26 allow the user to operate the blender without requiring a constant application of force to container 20 (to keep the motor switched on). An open end 22 of the blender container 20 can also comprise a lip 28 that extends along the outer perimeter of the blender container 20 . The lip 28 is at least flush or can extend beyond the perimeter of the top edge of the blender base 10 to prevent liquids or processed food from spilling into the blender base 10 . [0038] FIGS. 2 and 8 - 11 generally illustrate various configurations of a blender container 20 which may be adapted for small or large servings to be prepared/consumed by one and/or a few individuals. For example, FIGS. 10 and 11 generally show a blender container 20 having one open end 22 and one closed end 24 . The container 20 can have one or more handles 100 . The container 20 can be bullet-shaped and can include at least one protruding element 21 , such as an external ridge generally shaped to permit the container 20 to rest on its apex without tipping over. [0039] As shown in FIG. 11 , the container 20 is resting on a plurality of protruding elements 21 , allowing users convenient access to its interior. The number of protruding elements 21 , such as fin protrusions or ridges, may be varied as needed so long as the container 20 can stand upright on a substantially flat surface. In the alternative, a closed end 24 of the blender container 20 can have a flat surface rather than bullet-shape to stand upright without the need for one or more external protruding elements 21 . [0040] The embodiment shown in FIG. 11 is a mug-type drinking vessel 20 . The mug 20 with a removable lid 50 provides another serving and storing option. The mug 20 can have two handles 100 . A sipper top 120 , depicted in FIG. 17 , may be placed on top of the blender container 20 in place of a removable lid 50 . A sipper top 120 may be used to prevent spills when children use the mug 20 . The sipper top 120 can be affixed to an open end 22 of the container 20 via threads, a friction fit, snap-fit or other suitable type of attachment. [0041] The user may blend the contents of the blender container 20 ( FIG. 10 ), detach the container 20 from the blender base 10 , access the contents of container 20 with the container 20 standing upright on a flat surface, and store the contents for later use using a removable lid 50 ( FIG. 11 ). In such embodiments, the container 20 may be used as, besides a drinking vessel, an alternative storage cup 40 . The removable lid 50 can be affixed to an open end 22 of the container 20 via threads, a friction fit, snap-fit or other suitable type of attachment. Once the removable lid 50 is affixed, the container 20 may be inverted to rest on the lid. [0042] Another embodiment of the blender container 20 is shown in FIGS. 2 , 8 , and 9 . The blender container 20 can have two open ends, a first open end 22 and a second open end 23 . One open end 22 of the blender container 20 is adapted to connect with a removable blade adapter 30 having a blade member 32 , as described above. As shown in FIGS. 8-9 , the open end 22 of the blender container 20 that is capable of connecting to the removable blade adapter 30 can be provided with one or more locking members 26 . The locking members 26 can be spaced about the periphery of an open end of the container 20 . The open end 22 of the blender container 20 that can affix with a blade adapter 30 can also comprise a lip 28 that extends along the outer perimeter of the blender container 20 to prevent liquids or processed food from spilling on to the blender base 10 . The container 20 can include one or more handles 100 . [0043] The second open end 23 of the blender container 20 can attach to removable lid members 90 , 92 ( FIGS. 2 and 8 ). The lid member 90 may be partially open to provide access to the interior of blender container 20 . A second lid member 92 may be coupled to the first lid member 90 to cut off access to the interior of the blender container 20 . The lid member 90 may be locked on to the open top of the blender container 20 via a cap-locking member. The cap-locking member may be implemented, for example, as a generally L-shaped ridge disposed at the lip of an open end 23 of blender container 20 . The cap-locking member can engage a corresponding locking member on lid member 90 to securely lock the same to blender container 20 . Other suitable lid configurations may be utilized, as needed, such as a one-piece or a multi-piece lid cap and/or the like. [0044] The blender containers 20 can be adapted to hold a small or relatively larger volume of food and liquids. Larger sized blender containers 20 allow a user to process multiple food portions with one use and transfer the food portions to storage cups 40 or a food storage tray 80 for storage. [0045] The blender base 10 includes a recessed well 300 , as generally depicted in reference to FIGS. 3-4 . The blender base 10 includes a motor 500 ( FIG. 5 ) that is operatively coupled to an impeller 301 ( FIG. 3 ). The impeller 301 can comprise a plurality of symmetrically disposed blades 303 radiating from the center of impeller 301 . A plurality of bushings 305 ( FIGS. 3-4 ) may be utilized about the periphery of recessed well 300 . Alternatively, the blender base 10 may be adapted for use without utilization of bushings 305 . The bushings 305 may be made from a generally resilient material such as, but not limited to, rubber, silicone or the like to reduce vibrations during agitation of the container's 20 contents. [0046] The recessed well 300 is further provided with a plurality of pressure-activated switches 302 ( FIGS. 3-4 ). The removable blade adapter 30 is adapted to fit within the recessed well 300 and couple operatively to the impeller 301 . In use, the weight of the blender container 20 can cause the downward movement of the switches 302 thereby activating the motor 500 . A user may also press the blender container 20 to cause downward movement of the switches to activate the motor 500 . As generally shown in FIG. 3 , a locking groove 304 can be provided adjacent to the switch 302 . Accordingly, in use, when the locking members 26 ( FIGS. 8-11 ) contact and depress the respective switches 302 , the blender container 20 may be rotated by the user to allow the locking members 26 to engage the respective locking grooves 304 . [0047] As generally depicted in FIG. 6 , when a force F 1 is applied to the switch 302 , the switch 302 moves downward, i.e. in the direction of the applied force. This downward movement causes a cam 600 on the switch 302 to contact a motor power switch 501 thereby powering the blender motor 500 ( FIG. 5 ). Accordingly, depending on the intended use or application, the blender container 20 may be depressed to activate the motor 500 ( FIG. 5 ) for relatively short periods of time. For example, the user may want to pulse the blending action of the blender to create a thicker or chunkier consistency of food. [0048] Alternatively, the blender container 20 may be depressed and rotated slightly to allow the at least one locking member 26 to engage the respective locking grooves 304 , thereby permitting continuous operation of the motor 500 , i.e. without requiring the user to exert constant pressure on the container 20 to keep the motor running. The user may want to utilize this option to create a thinner or finer consistency of food. [0049] The system includes multiple storage devices to store freshly processed food in addition to the blender containers 20 . For example, as shown in FIG. 12 , a storage cup 40 with a freshness indicator 60 provides a storage option for foods processed by the blender portion of the system. The storage cup 40 can include one or more protruding elements 42 , such as ridges or fin protrusions extending from the closed end of the storage cup 40 shown in FIG. 12 . The protruding elements 42 also add a decorative element to the storage cup 40 and increase the stability of the storage cup 40 when it is placed on a surface, such as a table. The storage cup 40 can be made in different sizes to accommodate different uses and desired storage capabilities. The storage cups 40 can thereby be used to store various quantities of food portions. Each size of the storage cup 40 can have a respective removable lid 50 . The storage cups 40 can also be used as drinking vessels if desired. [0050] The storage cup 40 can include an indicator 60 to indicate the freshness of the food portion stored in the storage cup 40 . In one embodiment shown in FIG. 12 , the indicator 60 includes an indicator window 64 through which a reference indicium 66 is visible. In the depicted embodiment, the reference indicium 66 is a number that indicates the day of the month. For example, the “31” shown in FIG. 12 indicates the 31 st day of the month. The first through thirty-first days of a month can be printed about the outer perimeter of the storage cup 40 . Rotating a rotatable element 62 attached with the storage cup 40 can change the reference indicium 66 such that the desired date or number is shown through the indicator window 64 on the rotatable element 62 , while the remaining numbers are covered by the rotatable element 62 . The reference indicium 66 can also indicate the number of days the food will remain fresh or the number of remaining days that the food will remain fresh. In another embodiment, the blender containers 20 can include indicators 60 , each having a rotatable element 62 , an indicator window 64 , and a reference indicium 66 as described above. The indicators 60 of all embodiments can be adjustable and reusable and the reference indicium 66 need not be limited to numbers but may include a picture or word in alternative embodiments. [0051] As illustrated in FIG. 13 , the system can include a convenient tray 70 for storing multiple storage cups 40 . The cup storage tray 70 can be made of plastic and includes one or more receptacles 72 . Each receptacle 72 is shaped and dimensioned to accept a storage cup 40 . The receptacle 72 can include one or more slots 74 to align with the protruding elements 42 , such as the fin protrusions 42 shown in the figures, of the storage cup 40 . In the depicted embodiment, the cup storage tray 70 can hold six storage cups 40 . Also, the underside of the cup storage tray 70 is shaped and dimensioned to allow a cup storage tray 70 with storage cups 40 to be stacked on top of another cup storage tray 70 with storage cups 40 . In such a configuration, the removable lid 50 of each storage cup 40 fits into a recess on the underside of the cup storage tray 70 . In another embodiment, each receptacle 72 of the cup storage tray is adapted to receive a plurality of blender containers 20 in a similar manner as it receives the storage cups 40 , described above. [0052] A user can also transfer the freshly made food to a food storage tray, depicted in FIG. 14 . The food storage tray 80 can be made from a flexible material and has one or more cavities 82 . As shown in FIG. 15 , a storage tray cover 84 can be provided, and is dimensioned to fit over the top of the food storage tray 80 . In this way, when food is placed within the cavities 82 of the food storage tray 80 , the food can be covered by placing the storage tray cover 84 over the food storage tray 80 . The food storage tray 80 can also comprise a slightly raised lip 86 defining each cavity on the top side of the food storage tray. The storage tray cover 84 can have a plurality of complimentary recesses 88 formed in the bottom side of the cover 84 that fit over each lip 86 . When the cover 84 is affixed to the tray 80 , the lip 86 of each cavity 82 of the food storage tray 80 can fit within a respective recess 88 in the storage tray cover 84 to provide a sealed fit over each individual cavity 82 for improved preservation of the food. [0053] A method of using the food processor system can involve processing food, such as ingredients for baby food, with the blender components of the system. After the food is processed, the food can be transferred to the storage cups 40 by using the spatula 110 . The user can, for example adjust the indicator 60 by rotating a rotatable element 62 of the food storage cup 40 to set the reference indicium 66 before or after processing the food and transferring the food to the storage cups 40 . The reference indicium 66 may represent the date the food was placed into the storage cup 40 , the date in which food should be used by, or any other reminder freshness indicium 66 the user desires, including but not limited to the number of days in which the food will remain fresh or the number of days remaining in which the food will be fresh. Each storage cup 40 can be covered with a removable lid 50 before or after adjusting the indicator 60 . Alternatively, the food can be transferred to the food storage tray 80 , using the spatula 110 if desired, and covered with the storage tray cover 84 . The spatula 110 can be specifically formed to remove processed food from the blender containers 20 , food storage cups 40 , and/or food storage tray 80 . An example embodiment of a spatula 110 is shown in FIG. 16 . [0054] Once the processed food has been transferred to the desired storage containers, such as blender containers 20 , storage cups 40 , or food storage trays 80 , the prepared food can be stored in the refrigerator or freezer. Thus, multiple portions of freshly processed food can be prepared with one use of the system and subsequently saved among multiple storage devices. The user may use the individual servings as needed, without wasting any of the freshly made food. [0055] The blender containers 20 , removable blade adapter 30 , storage cups 40 , and food storage trays 80 can be made of BPA-free material and dishwasher-safe. For example, the blender containers 20 , storage cups 40 , and respective removable lids 50 can be made of BPA-free plastics or another suitable material. The food storage tray 80 and storage tray cover 84 can be made of BPA-free plastic, silicone, or other suitable material. When the food storage tray 80 is comprised of silicone, the cavities 82 are flexible so they can pop up from the tray 80 to allow easier remove the desired amount of food from the tray 80 . Accordingly, one can easily remove, or pop out, food portions that have been frozen in the food storage tray 80 , and the tray 80 can be reused. [0056] The method can yield multiple pre-planned portions of food servings. As a non-limiting example, each storage cup 40 and food storage tray's cavity 82 can be made to hold a two-ounce serving of freshly made baby food. Using an appropriately sized blender container, a user can make several portions of a baby food at one time. In addition, the user can add a desired amount of liquid such as water to achieve a desired consistency of the baby food. [0057] The following table provides non-limiting examples of produce that can yield certain, approximate numbers of baby food portions such that a user can plan a menu prior to performing the remaining steps of the method described herein. Certain foods may require pre-cooking prior to performing the method. [0000] Produce Yield of Two-Ounce Servings 1 cup cantaloupe 3 1 cup watermelon 3 1 cup pineapple 3 1 cup apricots 3 1 cup kale 3 2 plums 3.5 1 avocado 4 1 banana 4 1 cup peas 4 1 pear 4 20 spears of asparagus 4 1 carrot 4 ⅓ head of cauliflower 4 1 turnip 4 1 peach 5 1 cup green beans 5 1 apple 6 ⅓ head of broccoli 6 ½ an eggplant 6 1 turnip 4 1 white potato 8 1 zucchini 10 1 squash 10 1 cup of milled oatmeal 10 cereal 1 cup of milled millet 10 cereal 1 cup brown rice cereal 16 [0058] Utilizing this system and method, one can create a week's worth of baby food or more in less than five minutes. In addition, a user can pre-plan the amount of food he or she will make. One can also create a feeding schedule for a baby approximately four months and older, utilizing foods that are appropriate for the baby's age. This invention may be industrially applied to the development, manufacture, and use of food processors, particularly devices for producing baby food. While the present invention has been described with regards to particular embodiments, it is recognized that additional variations of the present invention may be devised without departing from the inventive concept. A person skilled in the art would appreciate that exemplary embodiments described hereinabove are merely illustrative of the general principles of the present invention. Other components, configurations, modifications or variations may be employed that are within the scope of the invention. Accordingly, the drawings and description are illustrative and not meant to be a limitation thereof. [0059] All terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. The term “adapted to” is drawn to a capability. Thus, it is intended that the invention cover all embodiments and variations thereof as long as such embodiments and variations come within the scope of the appended claims and their equivalents.

1a

RELATED APPLICATIONS [0001] This application is a continuation of U.S. Ser. No. 11/613,737, filed Dec. 20, 2006, which is a continuation of U.S. Ser. No. 10/882,514, filed Jul. 1, 2004, which is a continuation of U.S. Ser. No. 10/079,703, filed Feb. 20, 2002, and which application is incorporated herein in its entirety. FIELD OF THE INVENTION [0002] This invention relates to a method of treatment of dementia and/or regression of cognitive function, which method comprises co-administration of effective amounts of an ANG II antagonist and an ACE inhibitor, the latter one increasing bradykinin mediated effects, to a person in need of such treatment, and the use of an angiotensin II antagonist (ANG II) for manufacture of a pharmaceutical composition for treatment of said indications when used in combination with an angiotensin I converting enzyme inhibitor (ACE inhibitor). [0003] The beneficial efficacy of the methods according to the invention are based on organoprotective, tissue-protective and vasculoprotective effects on top of the blood pressure lowering effect of the combined treatment. BACKGROUND OF THE INVENTION [0004] ANG II plays a major role in pathophysiology, especially as the most potent blood pressure increasing agent in humans. ANG II antagonists therefore are suitable for treating elevated blood pressure and congestive heart failure in a mammal. Examples of ANG II antagonists are described in EP-A-0 502 314, EP-A-0 253 310, EP-A-0 323 841, EP-A-0 324 377, U.S. Pat. No. 4,355,040 and U.S. Pat. No. 4,880,804. Specific ANG II antagonists are sartans such as candesartan, eprosartan, irbesartan, losartan, telmisartan or valsartan, furthermore olmesartan and tasosartan. [0005] A series of ACE inhibitors are also known as antihypertensives and for treatment of congestive heart failure, e.g., benazepril, captopril, ceronapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, quinapril, ramipril, trandolapril, perindopril. Examples are described in EP-A-0 079 022, U.S. Pat. Nos. 4,046,889 and 4,374,829. [0006] It is known that ANG II, besides its blood pressure increasing effect, additionally features growth promoting effects contributing to left ventricular hypertrophy, vascular thickening, atherosclerosis, renal failure and stroke. Bradykinin, on the other hand, exerts vasodilating and tissue protective actions, as disclosed in the following publications: W. Wienen et al.: Antihypertensive and renoprotective effects of telmisartan after long term treatment in hypertensive diabetic (D) rats, 2 nd Int. Symposium on Angiotensin II Antagonism, Feb. 15-18, 1999, The Queen Elizabeth II Conference Center, London, UK, Book of Abstracts, Abstract No. 50, J. Wagner et al.: Effects of AT 1 receptor blockade on blood pressure and the renin angiotensin system in spontaneously hypertensive rats of the stroke prone strain, Clin Exp Hypertens 1998, 20: 205-221, and M. Böhm et al.: Angiotensin II receptor blockade in TGR (mREN2) 27 : effects of renin-angiotensin-system gene expression and cardiovascular functions, J Hypertens 1995, 13 8: 891-899. Losartan and irbesartan provide a renoprotective effect found within first clinical trials, as disclosed in the following publications: S. Andersen et al.: Renoprotective effects of angiotensin II receptor blockade in type 1 diabetic patients with diabetic nephropathy, Kidney Int 57 (2), 601-606 (2000), L. M. Ruilope: Renoprotection and renin-angiotensin system blockade in diabetes mellitus, Am J Hypertens 10(12 PT 2) Suppl),325S-331S (1997), J. F. E. Mann: Valsartan and the kidney: Present and future, J Cardiovasc Pharmacol 33 Suppl 1, S37-S40 (1999), E. L. Schiffrin et al.: Correction of arterial structure and endothelial dysfunction in human essential hypertension by the angiotensin receptor antagonist losartan, Circulation 101(14), 1653-1659 (2000), R. M. Touyz et al.: Angiotensin II stimulates DNA and protein synthesis in vascular smooth muscle cells from human arteries: role of extracellular signal-regulated kinases, J Hypertens 17(7), 907-916 (1999), E. L. Schiffrin: Vascular remodeling and endothelial function in hypertensive patients: Effects of antihypertensive therapy, Scand Cardiovasc J 32 Suppl 47, 15-21 (1998) and A. Prasad: Acute and chronic angiotensin-1 receptor antagonism reverses endothelial dysfunction in atherosclerosis, Circulation 2000; 101: 2349 cont. [0018] Furthermore, it has been found that the antiproteinuric effect of enalapril is potentiated by losartan in normotensive patients with diabetic nephropathy, as published in Am J Hypertens 13 (4, Part 2), 117A Abstr A017 (2000) referring to the 15th Sci Mtg of the American Society of Hypertension, 16-20 May 2000. [0019] Results of the Heart Outcomes Prevention Evaluation (HOPE) study (New Engl J Med 432/3, Jan. 20, 2000, p 145-153) indicate that treatment with ACE inhibitor ramipril significantly reduces the risk of the combined primary cardiovascular outcome by 22% and consistently reduces the risk for secondary endpoints of outcome, including total mortality. The cardiovascular benefit was shown to be largely independent from the blood pressure lowering effect suggesting that ramipril exerts an independent vasculoprotective and organoprotective effect. [0020] There is however also evidence that chronic treatment with ACE inhibitors does not suppress ANG II levels effectively due to compensatory activation of other ANG II-generating enzymes (e.g., human chymase, cathepsin G) which may have deleterious effects, particularly ongoing end organ damage, due to continued AT 1 receptor mediated action of ANG II (mechanisms described, e.g., in review article of Willenheimer, Eur. Heart J. 1999; 20, 997-1008). [0021] ANG II antagonists selectively block the AT 1 receptor, leaving the AT 2 receptor, which plays a role in anti-growth and tissue regenerative actions, unopposed. Completed clinical trials with ANG II antagonists appear to display similar blood pressure reducing and tissue protective effects as with ACE inhibitors, as disclosed in the following publications: D. H. G. Smith et al.: Once-daily telmisartan compared with enalapril in the treatment of hypertension, Adv. Ther 1998, 15: 229-240, B. E. Karlberg et al.: Efficacy and safety of telmisartan, a selective AT1 receptor antagonist, compared with enalapril in elderly patients with primary hypertension, J Hypertens 1999, 17: 293-302, and J. M. Neutel et al.: Comparison of telmisartan with lisinopril in patients with mild-to-moderate hypertension, Am J Ther 1999, 6, 161-166. [0025] Most recently, attention has been focused on the combination of both drug principles in the treatment of congestive heart failure based on the rationale to combine the benefits of ACE inhibition and bradykinin potentiation together with a more efficient inhibition of the Renin-Angiotensin-Aldosteron system via AT 1 receptor blockade and a shift of the actions of the remaining ANG II from the AT 1 to the AT 2 receptor (M Burnier, IDrugs 3 (3): 304-309, (2000)). Pharmacologically, this is a highly attractive approach, and large studies are currently ongoing in congestive heart failure (VAL-HeFT, Cardiology 1999, 91 (Suppl I), 19-22; CHARM, J Cardiac Failure 1999, 5: 276-282) to prove this hypothesis. [0026] Combined treatment and corresponding compositions comprising amounts of at least two therapeutic agents selected from the group consisting of a renin inhibitor, an ACE inhibitor and an ANG II antagonist, in amounts sufficient to cause synergistic therapeutic effects in lowering blood pressure and treating congestive heart failure in a mammal are disclosed in EP-A-0 527 879. Preferred ACE inhibitors are taught to be captopril, enalapril, lisinopril and ramipril. Losartan is disclosed as the preferred ANG II antagonist. Dosage ranges for ACE inhibitors are disclosed to include 40 mg/day to 450 mg/day orally and 20 mg/day parenterally. Dosage ranges for ANG II antagonists are disclosed to include 0.5 to 500 mg/kg p.o., preferably 2 to 80 mg/kg p.o., and 3 mg/kg i.v. [0027] EP-A-1 013 273 discloses the use of AT 1 receptor antagonists or AT 2 receptor modulators for treating diseases associated with an increase of AT 1 receptors in subepithelial area or increase of AT 2 receptors in the epithelia, especially for treatment of several lung diseases. SUMMARY OF THE INVENTION [0028] Co-administration of an ANG II antagonist with an ACE inhibitor provides unexpected advantages in the treatment of dementia and regression of cognitive function in comparison to administration of an ANG II antagonist or ACE inhibitor alone. [0029] According to a first aspect the present invention provides a method of treatment of dementia and regression of cognitive function, which method comprises co-administration of effective amounts of an ANG II antagonist and an ACE inhibitor to a human or non-human mammalian body in need of such treatment. [0030] In an especially preferred embodiment of the inventive method of treatment the ANG II antagonist is telmisartan and the ACE inhibitor is ramipril. [0031] Viewed from a further aspect the present invention provides the use of an ANG II antagonist for manufacture of a pharmaceutical composition for treatment of dementia and regression of cognitive function when used in combination with an ACE inhibitor, telmisartan and ramipril being especially preferred. DETAILED DESCRIPTION OF THE INVENTION [0032] With regard to aspects of the invention any ANG II antagonist can be suitable, unless otherwise specified, e.g., the sartans such as candesartan, eprosartan, irbesartan, losartan, telmisartan, valsartan, olmesartan and tasosartan mentioned hereinbefore, preferably losartan or telmisartan, most preferred telmisartan {4′-[2-n-propyl-4-methyl-6-(1-methyl-benzimidazol-2-yl)benzimidazol-1-ylmethyl]biphenyl-2-carboxylic acid} and the pharmaceutically acceptable salts thereof, furthermore, any ACE inhibitor can be used with regard to aspects of the invention mentioned hereinbefore, unless otherwise specified, e.g., benazepril, captopril, ceronapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, quinapril, ramipril, trandolapril, and perindopril, preferably captopril, enalapril, lisinopril and ramipril, most preferred ramipril. [0033] In a preferred embodiment of the method-of-treatment aspect ramipril is co-administered with an ANG II antagonist. [0034] In a second preferred embodiment of the method-of-treatment aspect an ACE inhibitor is co-administered with telmisartan. [0035] In a third preferred embodiment of the method-of-treatment aspect ramipril is co-administered with telmisartan. [0036] Co-administration of an ANG II antagonist and an ACE inhibitor is meant to include administration sequential in time or simultaneous administration, the simultaneous administration being preferred. For sequential administration, the ANG II antagonist can be administered before or after administration of the ACE inhibitor. [0037] The active compounds can be administered orally, bucally, parenterally, by inhalation spray, rectally or topically, the oral administration being preferred. Parenteral administration may include subcutaneous, intravenous, intramuscular and intrasternal injections and infusion techniques. [0038] The active compounds can be orally administered in a wide variety of different dosage forms, i.e., they may be formulated with various pharmaceutically acceptable inert carriers in the form of tablets, capsules, lozenges, troches, hard candies, powders, sprays, aqueous suspensions, elixirs, syrups, and the like. Such carriers include solid diluents or fillers, sterile aqueous media and various non-toxic organic solvents, etc. Moreover, such oral pharmaceutical formulations can be suitably sweetened and/or flavored by means of various agents of the type commonly employed for such purposes. In general, the compounds of this invention are present in such oral dosage forms at concentration levels ranging from about 0.5% to about 90% by weight of the total composition, in amounts which are sufficient to provide the desired unit dosages. Other suitable dosage forms for the compounds of this invention include controlled release formulations and devices well known to those who practice in the art. [0039] For purposes of oral administration, tablets containing various excipients such as sodium citrate, calcium carbonate and calcium phosphate may be employed along with various disintegrants such as starch and preferably potato or tapioca starch, alginic acid and certain complex silicate, together with binding agents such as polyvinylpyrrolidone, sucrose, gelatin and acacia. Additionally, lubricating agents such as magnesium stearate, sodium lauryl sulfate and talc or compositions of a similar type may also be employed as fillers in soft and hard-filled gelatin capsules; included lactose or milk sugar as well as high molecular weight polyethylene glycols. When aqueous suspensions and/or elixirs are desired for oral administration, the essential active ingredient therein may be combined with various sweetening or flavoring agents, colouring matter or dyes and, if so desired, emulsifying agents and/or water, ethanol, propylene glycol, glycerin and various like combinations thereof. [0040] For purposes of parenteral administration, solutions of the compounds in sesame or peanut oil or in aqueous propylene glycol may be employed, as well as sterile aqueous solutions of the corresponding pharmaceutically-acceptable salts. Such aqueous solutions should be suitably buffered if necessary, and the liquid diluent rendered isotonic with sufficient saline or glucose. These particular aqueous solutions are especially suitable for intravenous, intramuscular and sub-cutaneous injection purposes. In this connection, the sterile aqueous media employed are readily obtained by standard techniques well known to those skilled in the art. For instance, distilled water is ordinarily used as the liquid diluent and the final preparation is passed through a suitable bacterial filter such as a sintered glass filter or a diatomaceous-earth or unglazed porcelain filter. Preferred filters of this type include the Berkefeld, the Chamberland and the Asbestos Disk-Metal Seitz filter, wherein the fluid is sucked into a sterile container with the aid of a suction pump. The necessary steps should be taken throughout the preparation of these injectable solutions to insure that the final products are obtained in a sterile condition. For purposes of transdermal administration, the dosage form of the particular compound or compounds may include, by way of example, solutions, lotions, ointments, creams, gels, suppositories, rate-limiting sustained release formulations and devices therefor. Such dosage forms comprise the particular compound or compounds and may include ethanol, water, penetration enhancer and inert carriers such as gel-producing materials, mineral oil, emulsifying agents, benzyl alcohol and the like. [0041] Several ANG II inhibitors are already on the market and can be used for administration, e.g., Micardis®, Lorzaar®, Cozaar®, Lortaan®, Losaprex®, Neo-Lotan® or Oscaar®, Approvel®, Karvea®, Diovan®, Atacand®, Blopress® and Teveten®. [0042] Also several ACE-inhibitors are already on the market and can be used for administration, e.g., Briem®, Cibacen®, Cibacne®, Lotensin®, Dynacil®, Elidiur®, Fosinorm®, Fositen®, Fozitec®, Monopril®, Staril®, Tensozide®, Novaloc®, Tanapril®, Fempress®, Perdix®, Univasc®, Accupril®, Accuprin®, Accupro®, Acequin®, Acuitel®, Korec®, Quinazil®, Xanef®, Pres®, Acerbon®, Lopirin®, Tensobon®, Delix® or Vesdil®. [0043] The ACE inhibitor may be administered in a daily dosage of 1.25 mg (or 0.018 mg/kg, based on a person of 70 kg) to 450 mg (6.429 mg/kg) orally and of about 20 mg (0.286 mg/kg) parenterally, preferably of 5 mg (0.071 mg/kg) to 100 mg (1.429 mg/kg) orally. Particularly preferred is an oral daily dosage of 2.5 mg (0.036 mg/kg) to 10 mg (0.143 mg/kg). [0044] The ANG II antagonist may be administered in a daily dosage of 10 mg (or 0.143 mg/kg, based on a person of 70 kg) to 500 mg (7.143 mg/kg) orally and of about 20 mg (0.286 mg/kg) parenterally, preferably of 20 mg (0.286 mg/kg) to 100 mg (1.429 mg/kg) orally. Particularly preferred is an oral daily dosage of 40 mg (0.571 mg/kg) to 80 mg (1.143 mg/kg). [0045] In all administration modes and dosages mentioned hereinbefore the preferred ACE inhibitor is ramipril and the preferred ANG II antagonist is telmisartan. In the most preferred embodiment ramipril is administered simultaneously in a daily dosage of about 10 mg together with telmisartan in a daily dosage of about 80 mg via the oral route. [0046] Pharmaceutical compositions comprising one ACE inhibitor in an amount of 1.25 mg to 450 mg and one ANG II antagonist in an amount of 10 mg to 500 mg in single dosage units, optionally together with one or more pharmaceutically acceptable diluents and/or carriers, could be used for the method of treatment aspect of the invention. [0047] For instance, pharmaceuticals comprising one ACE inhibitor selected from benazepril, captopril, ceronapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, quinapril, ramipril, trandolapril and perindopril in an amount of 1.25 mg to 100 mg and one ANG II antagonist selected from candesartan, eprosartan, irbesartan, losartan, telmisartan and valsartan, olmesartan, tasosartan in an amount of 20 to 100 mg in single dosage units, optionally together with one or more pharmaceutically acceptable diluents and/or carriers would be suitable for the method of treatment according to the invention. [0048] The most preferred pharmaceutical compositions comprise as ACE inhibitor ramipril in an amount of 1.25 mg to 100 mg and as ANG II antagonist telmisartan in an amount of 20 mg to 100 mg, in single dosage units, optionally together with one or more pharmaceutically acceptable diluents and/or carriers. [0049] Especially preferred pharmaceutical compositions comprise as ACE inhibitor ramipril in an amount of about 10 mg and as ANG II antagonist telmisartan in an amount of about 80 mg in single dosage units, optionally together with one or more pharmaceutically acceptable diluents and/or carriers. [0050] As already mentioned above the present invention also provides the use of an ANG II antagonist for manufacture of a pharmaceutical composition for the treatment of the human or non-human mammalian body for treating the indications mentioned hereinbefore when used in combination with an ACE inhibitor. This use aspect is meant to include the manufacture of all pharmaceutical compositions mentioned hereinbefore.

1a

RELATED APPLICATIONS [0001] This application claims priority of U.S. Provisional Application Ser. Nos. 60/555,308, filed Mar. 23, 2004; 60/635,652 filed on Dec. 14, 2004 and 60/636,449 filed on Dec. 15, 2004. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to an apparatus and method for connecting a conduit to a hollow organ, and more particularly, to a surgical device connectable to the apex of a heart. [0004] 2. Description of the Related Art [0005] As the average age of the United States population increases, so do the instances of aortic stenosis. An alternative approach to the conventional surgical replacement of the stenotic aortic valve involves the use of an apicoaortic conduit. In this approach, the native aortic valve is not removed, and a prosthetic valve is implanted in a parallel flow arrangement. A connection conduit (or tube) connects the apex of the heart to the descending aorta. Somewhere along this conduit, the prosthetic valve is interposed. Thus, blood leaves the heart through the apex and travels through the conduit (with valve) to the descending aorta. [0006] Until recently, surgical procedures to implant an apicoaortic conduit have included a single, long incision, such as in the 6 th intercostal space, to expose the heart and allow retraction of the lungs to expose the descending aorta. Recognizing the potential for broader scale use of the apicoaortic conduit for aortic valve replacement, some surgeons are now attempting to use smaller incisions and are requesting development of surgical tools for a minimally invasive procedure. As an initial attempt to make the procedure less invasive, some surgeons have recently performed the following procedure. [0007] The patient is placed on the table in the supine position. Anesthesia is induced, and the patient is intubated with a double-lumen endotracheal tube, this facilitates one-lung ventilation and allows the surgeon to work within the left chest. The patient is positioned with the left side up (90 degrees). The pelvis is rotated about 45 degrees, such that the femoral vessels are accessible. An incision is made over the femoral vessels, and the common femoral artery and vein are dissected out. Heparin is administered. Pursestring sutures are placed in the femoral artery and vein. The artery is cannulated first, needle is inserted into the artery, and a guidewire is then inserted. Transesophageal echo is used to ascertain that the wire is in the descending aorta. Once this is confirmed, a Biomedicus arterial cannula is inserted over the wire, into the artery (Seldinger technique). The arterial cannula is typically 19 or 21 French. Once inserted, the pursestring sutures are snugged down over tourniquets. A similar procedure is followed for the femoral vein. The venous cannula is usually a few French larger than the arterial cannula. Once both vein and artery are cannulated, the cannulae are connected to the cardiopulmonary bypass, and the capability to initiate cardiopulmonary bypass at any time is present. [0008] A 1 cm incision is made in approximately the 7 th interspace in the posterior axillary line; the videoscope (10 mm diameter) is inserted, and the left chest contents viewed. The location of the apex of the heart is determined, and the light from the scope used to transilluminate the chest wall; this allows precise localization of the incision. The incision is then performed; it is essentially an anterior thoracotomy, typically in the 6 th interspace. Recent incisions have been about 10 cm long, but are expected to become smaller and smaller with time. A retractor is inserted and the wound opened gently. A lung retractor is used to move the (deflated) left lung cephalad. The descending aorta is dissected free from surrounding soft tissue to prepare for the distal anastomosis. This dissection includes division of the inferior pulmonary ligament. A pledgeted suture is placed on the dome of the diaphragm and positioned to pull the diaphragm toward the feet (out of the way). The pericardium is incised about the apex of the heart, and the apex is freed up and clearly identified. [0009] On the back table, the apicoaortic conduit is prepared: a 21 freestyle valve is sutured to an 18 mm Medtronic apical connector. The valve is also sutured to a 20 mm Hemashield graft. The Dacron associated with the apical connector is pre-clotted with thrombin and cryoprecipitate. The assembly is brought to the field, and a measurement made from the apex of the heart to the descending aorta. The assembly is trimmed appropriately. A partial-occluding clamp is then placed on the descending aorta, and the aorta opened with a knife and scissors. The conduit (the end with the 20 mm hemashield graft) is then sutured to the descending aorta using 4-0 prolene suture, in a running fashion. Once this is complete, the clamp is removed and the anastomosis checked for hemostasis. Blood is contained by the presence of the freestyle aortic valve. The apical connector is placed on the apex, and a marker is used to trace the circular outline of the connector on the apex, in the planned location of insertion. Four large pledgeted sutures (mattress sutures) of 2-0 prolene are placed; one in each quadrant surrounding the marked circle. The sutures are then brought through the sewing ring of the apical connector. A stab wound is made in the apex in the center of the circle, and a tonsil clamp is used to poke a hole into the ventricle. To date, bypass has been initiated at this point, but doing so may not be necessary. A Foley catheter is inserted into the ventricle, and the balloon expanded. A cork borer is then used to cut out a plug from the apex. The connector is then parachuted down into position. A rotary motion is necessary to get the connector to seat in the hole. The four quadrant sutures are tied, and hemostasis is checked. If there is a concern regarding hemostasis, additional sutures are placed. The retractor is removed, chest tubes are placed, and the wound is closed. [0010] Surgical tools developed specifically to implant the apicoaortic conduit are expected to provide the means for a much less invasive procedure. The procedure is expected to be performed with a series of smaller thoracotomy incisions between the ribs, such as immediately over the apex of the heart. In addition to avoiding the median sternotomy, development of appropriate surgical tools is expected to avoid the need for cardiopulmonary bypass, so that the procedure can be performed on a beating heart. The diseased aortic valve does not need to be exposed or excised. The stenotic aortic valve is left in place and continues to function at whatever level it remains capable of, and the apicoaortic conduit accommodates the balance of aortic output. [0011] The major obstacle, to widespread adoption of this superior technique is the nearly complete lack of efficient devices to perform the procedure. Surgeons wishing to adapt the procedure must gather a collection of instruments from a variety of manufacturers. Often these instruments were created for quite different purposes, and the surgeon is forced to adapt them as required and manually manipulate them during a procedure. [0012] U.S. Published Patent Application 2003/0130668 A1 (Nieman) describes a method and apparatus for remotely cannulating a body part, such as a heart. The method and apparatus are endoscopic, i.e the instruments are mounted on the end of a long flexible member and inserted into the body through a trocar, i.e., a sharply pointed surgical instrument contained in a cannula. The endoscopic procedure is complicated. After the device is placed at or near the apex of the heart, the surgeon or some other controller performs at least 13 separate steps to secure the cannula in the heart wall. An attachment ring (which includes an apical ring and a locking stem) is sutured to the heart wall, and subsequently the cannula is connected to the attachment ring as a separate step. Because the procedure is endoscopic, imaging means (e.g., fluoroscopy) is used to place a balloon at the correct depth within the ventricle to provide occlusion. [0013] The complex endoscopic procedure disclosed in Nieman appears to require that the cut tissue core be removed from the body prior to advancing the cannula to the heart wall. Further, Nieman appears to provide two mechanisms for placing the cannula in the heart wall. One such mechanism is to create a hole that is large enough to easily slide the cannula into the hole. This does not provide a tight fit between the cannula and cored heart wall to prevent blood loss from the cored heart wall and from the ventricle and relies entirely upon the sutured attachment ring to achieve hemostasis thus providing a period of time during which there could be great losses of blood. The second mechanism is to achieve a tight (interference) fit between the cannula and cored hole. However, such a tight fit requires substantial axial and torsional forces to be applied to the cannula. The flexible endoscopic instrument disclosed in Nieman cannot provide such forces to be transmitted [0014] U.S. Patent Publication No. 2004/0162608 (Haverich) discloses a method and apparatus for implanting a conduit into the wall of a heart. As illustrated in FIG. 8A , Haverich shows a conduit on a cutter that has a “corkscrew driver” with a coil. The corkscrew is rotated to cause the cutter to penetrate through the myocardium. However, substantial axial force is required to cleanly penetrate the myocardium, and such force is not easily applied by a corkscrew. Further, the pointed tip of the corkscrew can damage other areas of the heart wall (e.g., the septum) while applying axial force and rotation. Haverich discloses a balloon used for hemostasis. However, the balloon is a separate instrument that cannot be combined with the corkscrew. [0015] U.S. Patent Publication No. 2002/0045846 (Kaplon) discloses a device similar to Haverich except that a trocar is used to penetrate the organ wall instead of a cutter with corkscrew. No tissue plug is formed with a trocar. Use of a trocar makes it difficult to achieve hemostasis during a procedure-on a beating heart. To address this, rigid conduit 18 is inserted through the connector 16 after the connector is implanted with the trocar and sewn into place. Connector 16 does not appear to penetrate the heart wall. Connector 16 has a built-in valve to prevent blood loss after the trocar is removed and until conduit 18 is inserted SUMMARY OF THE INVENTION [0016] A connector conduit according to the preferred embodiment includes a rigid apical connector portion which will serve to provide egress from the left ventricle (such as from the apex or lateral wall), a flexible conduit portion which will carry blood from the connector to the arterial system (such as to the descending thoracic aorta or the ascending thoracic aorta), and the aortic valve itself, which will be situated somewhere within the conduit. The present invention primarily addresses implantation of an apical connector with an attached length of conduit, referred to herein as the connector conduit (or connector). The connector conduit is implanted using an applicator. Although this discussion focuses primarily on the apex of the left ventricle, it is understood that the present invention can be used to implant a connector conduit to any wall of the left ventricle or other hollow organ. [0017] As described earlier, the surgeon conventionally uses a cork borer to cut a tissue plug from the ventricle wall. Once the tissue plug is removed, the surgeon must attempt to occlude the resulting hole, such as with a finger, a balloon or some other occlusion means, until the connector conduit is inserted. Despite attempts to occlude the resulting hole, substantial blood loss is inevitable. Cardiopulmonary bypass is used to reduce blood loss. [0018] An object of the present invention is to integrate the cork borer and connector conduit to form a system in which the connector conduit is inserted into the ventricle wall as the tissue plug is being created, thereby eliminating the need for a separate occlusion means and greatly reducing blood loss. Such integration may be achieved by mounting the connector conduit directly onto the outer diameter of a coring element or integrating the cutter and the connector conduit, which cuts the tissue plug and occludes blood flow through the inner diameter. In this way, the cross sectional area for blood loss is reduced to the gap between the coring element and connector conduit. [0019] Another object of the present invention is to combine the coring element with other features to form a complete applicator for securing the connector conduit into the ventricle wall. These features may include a mounting element and a handle element. The mounting element is an extension to the coring element that serves to add axial length to the coring element onto which the full length of the connector conduit may be mounted. The mounting element may be of the same diameter as the coring element. The handle element provides a grip to facilitate the necessary positioning, twisting and pushing force necessary to cut the tissue plug and to insert the connector into the ventricle wall. The handle could have a pistol handle shape, for example. [0020] Another object of the present invention is to provide the option for additional features for the complete applicator system for securing the connector conduit into the ventricle wall, particularly at the apex. These additional features may include a retractor element and a quick connect coupling element. [0021] The refractor element may have an expanding element for: 1) shaping the apex of the ventricle into a preferred shape for cutting the tissue plug, 2) providing a backing surface for the coring element in order to sandwich the heart wall between the coring element and expanding element, 3) pulling the tissue plug to within the coring element, and/or 4) ensuring that the tissue plug remains inside the coring element. The expanding element could be a liquid-inflated balloon sponge, or a mechanically-operated umbrella, as examples. [0022] The expanding element is mounted onto the retractor element, and the retractor element is slide-ably mounted within the coring element. A coupling element, such as a compression spring, provides the force to move the retractor element relative to the coring element. The retractor element may be designed to prevent relative rotation between the expanding element and coring element, thereby reducing the likelihood of damage to the expanding element. The retractor element may also include a section of increased diameter that abuts the outer heart wall to prevent premature or undesired cutting of the ventricle wall by preventing contact between the coring element and ventricle. [0023] Another object of the present invention is to provide an expanding element that has a similar look and feel as the conventional procedure. For example, the expanding element may be a balloon. A syringe element may expand the expanding element to a predetermined level by inflation with a liquid. To minimize the space required for the syringe, the balloon may be designed specifically to require minimal inflation volume while still performing the necessary functions of the expanding element. In addition, a filling element of the applicator may provide the means to fill the syringe element and balloon from an external liquid source and to provide the means to purge air from the expanding element. [0024] Another object of the present invention is to provide a connector conduit that has many of the features of the conventional apical connector (e.g., Medtronic™ apical connector) and includes additional features to make it compatible with the applicator and the surgical procedure. Additional features to make the connector conduit compatible with the applicator include 1) an ability to straighten the connector conduit from a bent configuration so that it will slide onto a straight mounting element, 2) a modified leading edge on the connector to ease insertion into the heart wall, and 3) a clamping element that includes portions of both the connector conduit and the applicator which serves to lock the connector conduit to the applicator in a predetermined position and to facilitate applying the twisting and pushing force necessary to insert the connector. [0025] An additional feature of the connector conduit to make it compatible with the surgical procedure is a quick connect coupler to expedite attachment of the connector conduit to the remainder of the prosthesis, which includes the prosthetic valve. The quick connect coupler is necessary to prevent a long time delay between implanting the connector conduit into the ventricle and achieving blood flow through the complete prosthesis. Such quick connect coupler may consist of a first part that is attached to the connector conduit and a second part that is attached to the remainder of the prosthesis, which includes the prosthetic valve. [0026] An additional feature of the connector conduit to make it compatible with the surgical procedure is to provide a length of conduit that may be collapsed, such as with an occlusion clamp, to prevent blood flow through the connector conduit before the quick connect coupler is connected and the surgeon is ready to allow blood flow through the complete prosthesis. [0027] In one configuration of the invention, expansion of the expanding element and the position of the retractor element are controlled independently by the surgeon. For example, if the expanding element is a balloon connected to a syringe, the volume of liquid in the balloon is controlled by the position of the plunger inside the syringe. Similarly, a bolt may be used to control the position of the retractor element relative to the coring element. In this configuration, the surgeon must independently control the positions of the syringe plunger and the retractor element bolt. [0028] Another configuration of the present invention provides a sequencing element (such as a cam mechanism) that ensures that critical steps of the procedure are performed in the proper sequence. The sequencing element synchronizes expansion of the expanding element with position of the retractor element. The sequencing element includes a sequencing bolt. The surgeon uses one hand to hold the applicator handle and the other hand to slide the sequencing bolt. In this way, independent control of the expanding and retractor elements is eliminated. Independent positions of these components are not user driven; rather, positions of these components are synchronized by the sequencing element. One example of a sequencing element is described next; however, it is understood that a sequencing element may be used to control fewer steps or additional steps of securing the connector conduit into the ventricle wall. [0029] The system is set up with the connector conduit mounted onto the applicator and with the retractor fully extended. The procedure begins by making a small knife wound in the apex and pushing the retractor element (with fully-deflated expanding element) through the heart wall and into the ventricle. The surgeon slides the sequencing bolt from a first position to a second position. Once the sequencing bolt is in the second position, the surgeon may release the sequencing bolt. The sequencing element ensures that this sliding motion serves to first expand the expanding element and, after the expanding element is fully expanded, to release the retractor element so that the retractor element can move the expanding element relative to the coring element. The surgeon may now use the handle to apply twisting and pushing force to place the connector conduit into the ventricle wall. During this time, the sequencing element simultaneously coordinates: a. application of compressive force between the expanding element and the coring element, thereby sandwiching and shaping the heart wall for cutting the tissue plug, b. the coring element to cut a hole in the ventricle wall, thereby creating a tissue plug, c. insertion of the connector conduit into the hole, and d. the retractor element to retract the tissue plug from the hole into the coring element. [0034] Once the tissue plug is created, the sequencing element partially reduces the diameter of the expanding element so that the expanding element can enter the inner diameter of the coring element while remaining of large enough diameter to prevent the tissue plug from sliding off of the retractor element. This change in diameter of the expanding element occurs automatically to a pre-set intermediate diameter without attention from the surgeon. Once the surgeon has placed the connector conduit at the desired position within the ventricle wall, the applicator may be removed. [0035] In a preferred configuration, the connector conduit is a fabric (e.g., Dacron) covered device that is specifically designed for insertion into the wall of the left ventricle, such as at the apex. It contains a structural frame, a sewing flange (or suture ring) for attachment to the heart, and a standard fabric (e.g., Dacron) flexible vascular graft that extends through the lumen of the entire length of the structural frame and for some additional length beyond. An outer fabric may also cover the outside of the structural frame. The components of the connector conduit are interconnected, such as with polyester thread. The fabric may include orientation marks, such as a line along the length of the conduit. In addition, a quick connect coupling may be used to attach the connector conduit to the remainder of the prosthesis, which includes the prosthetic valve or ventricular assist device, as examples. [0036] A function of the structural frame is to provide mechanical integrity, i.e., rigidity, for the connector conduit. The structural frame may include a leading edge, a cage, a bend, and a holder. The leading edge is the first portion of the structural frame to be pushed through the heart wall. To minimize effort needed to push the connector through the heart wall, such leading edge may be tapered and/or beveled, for example. The cage is the portion of the structural frame that resides within the heart wall. The bend is the portion of the structural frame that holds the conduit in a preferred shape to direct blood flow from the left ventricle to the aorta, as described next in more detail. The holder is the portion of the structural frame that provides a means of mechanical connection between the connector conduit and applicator. [0037] The bend in the structural frame may be any appropriate angle (such as 90 degrees) to properly direct the conduit from the ventricle to the portion of the aorta where the conduit is to be connected. For example, the bend in the structural frame may be around 90 degrees if the conduit is to be connected to the descending thoracic aorta, or a larger angle bend may be used if the conduit is to be connected to the ascending thoracic aorta, for example. As described next, such bend may be flexible or rigid. [0038] In one embodiment, the bend of the structural frame may be flexible. For example, a set of equally-spaced circular rings mounted perpendicularly on a spine could form a bend that can flex to a range of angles. The circular rings provide radial support to prevent collapse of the conduit due to external forces. The spine may be at the outer radius of the bend or at the inner radius of the bend, as examples. In this embodiment, the bend can be straightened out from a preferred angle such that a mounting element of the applicator may be inserted straight through the lumen of the connector. Upon removal of the mounting element, if the bend is constructed of a material with a relatively high modulus of elasticity (e.g., PEEK), the connector returns to its bent configuration. If the bend is constructed of a material with a relatively low modulus of elasticity (e.g., polypropylene, polyethylene), the connector forms the bent configuration only when an external force is applied, such as by a bending means. Such bending means could involve pulling on threads that are weaved through the circular rings so that the bend is formed when the threads are pulled, for example. When the bend is at the preferred angle, the user may tie or crimp the threads together, for example, thereby preventing straightening of the bend. Such bending means allows the user to select any one of a plurality of possible bend angles as the preferred angle. Such bending means may also be used with a bend constructed of a material with a relatively high modulus of elasticity, such as to prevent straightening beyond the preferred angle. [0039] In another embodiment, the bend of the structural frame may be rigid. In this embodiment, since the bend cannot be straightened out, the bend must include a port such that the mounting element of the applicator may be inserted through such port and through the lumen of the cage. In this embodiment, the conduit must include a branch of additional conduit to form a Y. Such additional branch of conduit is coaxial with the cage for mounting the connector conduit onto the applicator. Once the connector conduit is implanted into the heart wall and the applicator is removed, the branch of conduit is occluded, such as by sewing or stapling the conduit closed, for example. The branch is then removed, such as by cutting with scissors. [0040] In another embodiment of the connector conduit, a quick connect coupler may be used to attach the connector conduit to the remainder of the prosthesis, which includes the prosthetic valve. The complete prosthesis may be divided into two parts: a first part that includes the prosthetic valve with lengths of conduit attached to both the upstream and downstream sides of the prosthetic valve and a second part that includes the connector conduit. The quick connect coupler allows the surgeon to rapidly connect said first part to said second part. In this way, the surgical procedure may be performed by first attaching said first part of the complete prosthesis to the aorta. Then, after the connector conduit is secured into the ventricle wall, the quick connect coupler allows rapid completion of the flow circuit to minimize the time between insulting the heart by cutting the hole and reducing the work load on the heart by allowing blood flow through the prosthesis. [0041] An applicator is used to implant the connector conduit into the ventricle wall. In a preferred embodiment, the applicator provides mechanical support on the surfaces of both the inner diameter and the outer diameter for some portion of the fabric-covered structural frame. Such support may be necessary to avoid unwanted distortion or movement of the structural frame while the connector conduit is being implanted through the heart wall. For example, the mounting element of the applicator, which is inserted straight through the lumen of the connector, may provide mechanical support (such as radial support) on the inner-diameter surface to reduce distortion of the structural frame during implantation. On the outer-diameter surface, the applicator may include a concentric tubular structure, referred to as the pushing element. The pushing element provides mechanical support (such as radial support) on the outer-diameter surface of the structural frame to reduce distortion during implantation. In a preferred embodiment, the mounting element and the pushing element are rigidly connected. [0042] In a related embodiment, an indexing means provides an interface between the pushing element and connector conduit that may prevent or greatly reduce rotation and/or axial movement of the connector conduit relative to the pushing element. As such, rotary or axial force applied to the pushing element is transmitted to the connector conduit through the locking means. An effective locking means may incorporate portions of the pushing element, mounting element and connector conduit. For example, the indexing means may include a slot-and-key arrangement that 1) positions the connector conduit at a preferred angle relative to the pushing element thereby orienting the bend in the structural frame, 2) prevents axial and rotary motion of the connector conduit relative to the pushing element, and 3) allows the connector conduit to be easy mounted onto and released from the applicator. Such indexing means may include a pushing element with an adjustable diameter that allows both rigid mounting and unhindered release of the connector conduit. Such indexing means may also include a connector conduit with a holder that locks to the pushing element, such as with a slot-and-key arrangement and/or with a tight friction fit, as examples. Such holder may be sandwiched firmly between the mounting element and pushing element. [0043] In a preferred configuration, the mounting element extends from a coring element that shares the same axis and has the same outer diameter as the mounting element. The coring element is used to cut a hole into the heart wall. Such coring element could consist of a thin-walled tube, the leading edge of which has been sharpened or serrated. The inner diameter of the connector conduit could fit snugly on the outer diameter of the coring element and mounting element. In use, the coring element could produce a hole in the heart wall that is smaller than the outer diameter of the connector conduit, thereby producing a snug fit. [0044] In a related embodiment, a handle may be rigidly attached to the pushing element. The handle may be at a substantially right angle after the manner of a pistol grip, for example. Such a handle attachment provides a more effective method of applying the insertion force and back-and-forth rotation needed to implant the connector conduit. [0045] In a preferred configuration, located concentrically within the mounting element is a retractor element consisting of a generally tubular structure having a pointed end that is inserted through the left ventricle wall. The tubular structure could be rigid. In a preferred embodiment, the pointed end of the retractor element could be a blunted point. In this way, after a small knife wound is made in the epicardium (outer surface of the heart), the blunted point could enter the knife wound and divide muscle fibers to penetrate the myocardium and left ventricle chamber. A purpose of the blunted point is to reduce the likelihood of damage should the point unintentionally contact other areas of the inner wall during use. In an alternative embodiment, the retractor element could include a very sharp pointed end being capable of producing its own entrance hole into the wall of the heart. Alternately, it could have a blunted point that would simply follow a previously created hole through the entire thickness of the ventricle wall. If so desired, the tubular structure of the retractor allows use of a guide-wire to follow a previously created hole. [0046] Near the pointed end of the retractor element is an expanding element, such as an inflatable balloon, an unfolding umbrella-like construction, an expandable collar, or similar structure. Once inside the ventricle, the expanding element is expanded from an initial diameter that may approximate the outer diameter of the retractor element to a second diameter. In a preferred configuration, the expanding element expands to a second diameter that is larger than the outer diameter of the coring element. The expanding element expanded to its second diameter seats snugly against the inside wall of the ventricle. Functions of the expanding element may include 1) expanding symmetrically to shape the inner wall of the ventricle into a preferred shape for cutting the tissue plug, and 2) fully retracting to within the coring element while remaining at least partially expanded. [0047] A first function of the expanding element is symmetric expansion, which provides at least two benefits. The first benefit is related to the variable, cone-shaped geometry of the left ventricular chamber near the apex. Symmetric expansion of the expanding element to a diameter that is larger than the outer diameter of the coring element effectively flattens out the ventricle wall in the vicinity of the apex so that the ventricle wall is more perpendicular to the sharpened leading edge of the coring element, thereby allowing the coring element to cut through the entire thickness of the ventricle wall. The tubular structure of the retractor element must resist the radial reaction forces from the ventricle walls. The second benefit of symmetric expansion is to ensure contact between the expanding element and the leading edge of the coring element along its entire circumference as the tissue plug is formed. Asymmetric expansion of the expanding element can result in formation of a plug with hanging attachments to the left ventricle wall. [0048] A second function of the expanding element is to fully retract and retain the plug within the coring element after the plug is cut. Such full retraction ensures that the applicator will slide out of the connector conduit (after the connector is implanted) without the plug and expanding element coming into contact with the inner diameter of the connector conduit. Such contact could increase the force required to remove the applicator from the connector conduit and could possibly result in debris from the removed plug being deposited on the inner diameter of the connector conduit. In addition, the expanding element must remain at a large-enough diameter after being retracted to within the coring element to ensure that the plug cannot slide off the end of the retractor element. [0049] In a related embodiment, this second function could include a coupling element that forces the retractor element to retract within the mounting element. In a preferred configuration, the coupling element could be a compression spring, for example. In this configuration, the retractor element could be slide-ably connected to the mounting element by means of the compression spring. The force produced by the compression spring tends to pull the expanding element snugly against the inside wall of the ventricle and to pull the tissue plug into the coring element after the tissue plug is detached from the ventricle. Alternatively, the user could manually provide the necessary force to retract the retractor element to within the coring element. [0050] In a preferred embodiment, the expanding element can be: 1) initially at a first diameter that approximates the outer diameter of the retractor element, 2) expanded to a second diameter that is larger than the outside diameter of the coring element, and 3) then reduced to a third diameter that is smaller than the inside diameter of the coring element but larger than the outer diameter of the retractor element. Inflation to the second diameter accommodates the first function of the expanding element (described above), and reducing to the third diameter accommodates the second function of the expanding element (described above). [0051] In a preferred embodiment, the expanding element is a balloon. The balloon may be inflated using an access means, such as a plunger in cylinder configuration (like a syringe) connected to the balloon by a flow passage, such as a channel integrated into the retractor element. An appropriate fluid to inflate the balloon could be saline, for example. The balloon material should be selected to best perform the functions of the expanding element. Polyurethane is a preferred material. Polyurethane is an elastic material that allows a balloon to be expanded symmetrically to as much as twice the original volume using a hand-held syringe. Such balloons are strong, abrasion resistant, and durable. Use of latex, another elastic material, is less desirable. Latex balloons typically expand asymmetrically, so use of a latex balloon as the expanding element could necessitate a means integrated into the balloon to ensure symmetric expansion. In the present invention, a latex balloon could be inflated to a symmetric diameter as determined by tension rods or sutures, for example, attached to the balloon and the retractor element. Once the tissue plug is formed, the plunger could be displaced to reduce the size of the balloon to allow retraction into the coring element. A means to prevent damage to the latex balloon by the coring element may be used. Alternatively, the balloon may be constructed of polyethylene terephthalate (PET; trade names include Dacron and Mylar), which is a non-elastic material. Balloons made of PET may be symmetrically inflated to higher pressures without appreciable change in the balloon volume. [0052] In one configuration of the present invention, expansion of the expanding element and the position of the retractor element are controlled independently by the surgeon. Consider the example of using a balloon as the expanding element. Inflation of such balloon could be fully controlled by the surgeon, such as by using a finger to displace a plunger inside a cylinder. In such case, the surgeon could inflate the balloon to any volume up to the maximum volume of the plunger/cylinder. Also in this configuration, the position of the slide-able retractor element relative to the coring element may be independently controlled by means of a bolt attached to the retractor element that passes through an indexed slot in the mounting element. In a preferred embodiment with the mounting element rigidly connected to a pushing element, the indexed slot could be in such pushing element. As the bolt is moved from one indexed position in the slot to another, the retractor is advanced or retracted relative to the coring element. In a preferred configuration with compression spring coupling between the retractor element and coring element, an indexed slot with the retractor element fully advanced (ready for insertion into the left ventricle wall) could be used. The bolt could then be manually released from the indexed slot after inflating a balloon on the retractor element. The compression spring would then pull the balloon firmly against the inner heart wall, thereby sandwiching the heart wall between the balloon and coring element. [0053] Independent control of the expanding element and retractor element could require increased surgeon training to ensure operation of these elements in the proper sequence. Alternatively, various latching or locking means could be used. For example, once the balloon has been inflated to a preset maximum volume, a latching means could lock the plunger into place, thereby preventing unintentional deflation of the balloon. If necessary, deflation to an appropriate volume for retraction into the coring element could be automatically triggered when the retractor element reaches a preset position during retraction. Alternatively, inflation and deflation of such balloon to preset maximum and reduced volumes could occur automatically, such sequence being initiated by pressing a spring-loaded trigger that displaces the plunger, for example. In addition, a safety latch or other means could prevent manual release of the bolt until the expanding element is fully expanded. These separate latching or locking means could result in a complicated mechanical configuration. [0054] In a preferred configuration of the present invention, a sequencing element, such as a cam mechanism, is used to coordinate expansion of the expanding element with position of the retractor element. Control of the expanding element and control of the retractor element position are coordinated so that the surgeon need only move a single sequencing bolt to control both the expanding element and the retractor element. The specific actions of the expansion element and retractor element that are controlled by the sequencing element may be chosen by the device designer to best accommodate the degree of control preferred by surgeons. [0055] In one embodiment of a preferred configuration that includes a sequencing element, the cylinder used to inflate/deflate the balloon (the syringe cylinder) may be integrated into the retractor element. Thus, the syringe cylinder, retractor element, balloon, and flow passage connecting the syringe cylinder to the balloon are integrated into a single component, referred to as the retractor assembly. The plunger used to inflate/deflate the balloon (the syringe plunger) may include a sequencing bolt extending radially from the plunger axis. Such sequencing bolt also extends radially through a slot in the syringe cylinder. As such, the slot in the syringe cylinder limits axial movement of the plunger in the syringe cylinder. By having a plurality of circumferentially interconnected slots of various axial lengths in the syringe cylinder, the degree of balloon inflation may be controlled by moving the sequencing bolt to a preferred axial slot. Synchronization of balloon inflation/deflation with motion of the retractor assembly relative to the pushing element (which is rigidly connected to the mounting element) may be achieved with two cam slots in the pushing element, for example. The first cam slot controls motion of a cam follower rigidly attached to the retractor assembly, thereby controlling the position of the retractor assembly relative to the pushing element. The second cam slot synchronizes inflation/deflation of the balloon relative to the position of the retractor assembly within the pushing element. The sequencing bolt serves as the cam follower in the second cam slot. Safety features may be integrated into the design of the cam mechanism. For example, the cam and follower can be designed to prevent movement of the retractor assembly relative to the pushing element (which is rigidly connected to the coring element) until the balloon is fully inflated. [0056] Various other features may be included to ensure safety and proper use of the connector conduit with applicator. For example, a port with a two-way valve may be integrated into the plunger/cylinder with balloon system to allow for filling with fluid and removal of air. As another example, a mounting tool may be used to mount the connector conduit over the coring element without damage to the fabric. As another example, a folding tool may be used to squeeze fluid from the balloon and to fold the balloon for use. As another example, the mounting tool and folding tool may be integrated into a single tool. [0057] The invention facilitates procedures using an integral device in which the various steps are preformed in a coordinated, i.e. sequenced manner. This renders the procedure simple and safe and reduces the likelihood of tissue damage or other complications. Other features and advantages of the invention will be apparent from the detailed description and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0058] FIG. 1 illustrates an apicoaortic conduit. [0059] FIG. 2A is a perspective view of the structural frame of one embodiment of a connector shown in a bent configuration. [0060] FIG. 2B is a perspective view of the structural frame of the connector of FIG. 2A shown in a straight configuration. [0061] FIG. 3A is a cross-sectional view another embodiment of the structural frame of the connector, covered in fabric, with an incorporated sewing flange and shown in the bent configuration. [0062] FIG. 3B is a cross-sectional view of the structural frame of the connector of FIG. 3A shown in a straight configuration. [0063] FIG. 3C is a cross-sectional view of the connector of FIG. 3A shown in the straight configuration, and with a fabric conduit in place. [0064] FIG. 4 is a cross-sectional view of an embodiment of the device showing the coring element and the retractor element in place within the straightened connector. [0065] FIG. 5 is a cross-sectional view of a cylinder plug tool that slides over the retractor element and into the coring element, which is used to load the connector-conduit onto the coring element. [0066] FIG. 6 is a cross-sectional view of an embodiment of the device showing the placement of a compression spring between the retractor element and the coring element. [0067] FIG. 7 is a cross-sectional view of another embodiment of the device showing the placement of a pushing element. [0068] FIG. 8A is a cross-sectional view of yet another embodiment of the device showing the attachment of a handle to the pushing element with an access means for the expandable element integrated into the pushing element, wherein the expandable element is shown contracted. [0069] FIG. 8B shows the embodiment of FIG. 8A with the expandable element expanded. [0070] FIG. 9 is a cross-sectional view of an embodiment of the device showing the inclusion of a sliding bolt on the retractor element and related indexed slots on the pushing device. [0071] FIG. 10 is a partial view the pushing element of FIG. 9 showing the indexed slots on the pushing device. [0072] FIG. 11A is a perspective view of a flexible structural frame of another embodiment of the connector conduit shown in a straight configuration. [0073] FIG. 11B is a perspective view of the structural frame of FIG. 11A shown in a bent configuration. [0074] FIG. 11C is a perspective view of the structural frame of FIG. 11B shown with a beveled and tapered leading edge. [0075] FIG. 12 is a perspective view of an alternative embodiment of FIG. 10B . [0076] FIG. 13A is a perspective view of the flexible structural frame of FIG. 11B shown in the straightened configuration and incorporating a bending means. [0077] FIG. 13B is a perspective view of the structural frame of FIG. 13A after activating the bending means. [0078] FIG. 14 is a perspective view of a non-bendable structural frame of a connector conduit. [0079] FIG. 15 is a cross-sectional view of a connector conduit shown in a bent configuration. [0080] FIG. 16 is a cross-sectional view of a non-bendable connector conduit. [0081] FIG. 17A is a cross-sectional view of a mounting element (including a coring element) and a pushing element of the applicator with a loaded connector conduit. [0082] FIG. 17B is a cross-sectional view FIG. 17A without the connector conduit. [0083] FIG. 18A is a perspective view of a squeeze ring for a locking means to secure the connector conduit within the applicator. [0084] FIG. 18B is a perspective view of a locking means shown in the locked position. [0085] FIG. 18C is a perspective view of a locking means shown in the unlocked position. [0086] FIG. 19 is a cross-sectional view of the device of FIG. 17B including a retractor element. [0087] FIG. 20 is a cross-sectional view of a folding and mounting tool. [0088] FIG. 21 is a cross-sectional view of an assembly including an applicator having a syringe. [0089] FIG. 22A is a cross-sectional view of a sequencing belt. [0090] FIG. 22B is a cross-sectional view of the retractor body and expanding element. [0091] FIG. 22C is a cross-sectional view of the positioning mans and coring element. [0092] FIGS. 23A-23C the sequencing can mechanism in various states. [0093] FIGS. 24A-24E illustrate the applicator in various states. [0094] FIG. 25 is a perspective view of an integrated connector conduit and cutting elements. [0095] FIG. 26 is the device of FIG. 25 with the cutting element withdrawn. [0096] FIG. 27A-27D illustrate components of a retractor having an expandable umbrella element. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0097] FIG. 1 is an illustration of an apicoaortic conduit, which extends from the apex of the left ventricle to the descending aorta with a prosthetic valve positioned within the conduit. The preferred embodiment of the present invention includes aspects of the connector conduit and an applicator used to implant the connector conduit. [0098] The connector-conduit with applicator of the present invention is best described as consisting of five major parts: a connector-conduit, a retractor, hole forming device such as a coring element, a pushing component, and a handle. A fabric material pleated conduit of a type common and well known in the field is permanently fixed to the inner surface of a rigid connector to form the connector-conduit. The conduit extends from the forward edge of the connector and continues beyond the connector, as a flexible portion, for some distance. [0099] The connector-conduit includes a rigid portion defined by an internal support structure made of a suitably flexible material that is preferentially biased to assume a bent configuration (such as a right angle) upon removal of restraining forces. In one embodiment, the connector internal support structure is covered with fabric, such as knitted or woven Dacron, for example. A suturing ring is integrated into the covering fabric and provides a suitable flange for suturing the connector to the surface of the heart. The leading edge of the connector is tapered to facilitate insertion of the connector-conduit component. The “rigid” portion is rigid enough to facilitate insertion as described below and to maintain the hole in an open position. However, the rigid portion can be flexible. Accordingly, the term “rigid” as defined herein means relatively rigid and can include flexibility. [0100] As shown in FIG. 2A , the structural frame 10 of the connector-conduit is a series of circular rings 14 joined to a curved spine 18 . During implantation, the curved spine 18 is straightened, as shown in FIG. 2B , resulting in a straight pathway for the passage of instruments. As an alternative, the connector-conduit could include circular rings 14 without curved spine 18 . As such, the circular rings would prevent collapse of the conduit, but the curved conduit would be formed manually after implantation, rather than by being formed by the curved spine 18 . As another alternative, a modified coil spring in the shape of a curve could be used instead of circular rings 14 and curved spine 18 . Properties of the coil spring would be chosen to prevent radial collapse and to provide appropriate stiffness of the curved position. [0101] The leading edge of structural frame 10 is a taper 20 which allows for easy insertion of the connector through the ventricle wall. The material of the structural frame 10 could be a shape memory alloy (e.g., Nitinol), plastic, or other similar biocompatible material. [0102] FIG. 3A illustrates a fabric covering 24 over the outside surface of structural frame 10 . Because connector surface 22 is in contact with the myocardial hole after implantation, a suturing ring or flange 26 is incorporated into the fabric covering 24 to provide an attachment site for sutures to anchor the connector to the heart. The fabric covered suture ring 26 could be made of a biocompatible foam or rubber. [0103] FIG. 3B shows the fabric covered structural frame 10 and suturing flange 26 in a straightened position. The straightened position can be achieved by, for example, inserting a straight instrument through the lumen of the frame. Alternately, the structure can be held in the open position through the use of stay stitches 28 , or the like, placed such that the circular rings 14 are held in close proximity. [0104] FIG. 3C is a view similar to FIG. 3B , showing the structural frame in the straightened position with a pleated fabric conduit 30 . Conduit 30 extends from taper 20 of the structural frame 10 , through the length of the structural frame 10 , and for some additional length beyond the structural frame 10 to define a flexible portion of the connector conduit. An orientation marker (not shown) on connector surface 22 , for example, is used to identify the direction that conduit 30 will be oriented once implanted into the heart. The orientation marker is visible at all times to assist the surgeon while placing the connector-conduit 32 into the connector-conduit applicator and to facilitate implantation at an appropriate angle into the heart. Also, a radiopaque marker(s) (not shown) may be integrated into the entire length of fabric covering 24 and conduit 30 to facilitate identification and location of the structure by X-ray or other means. [0105] Referring to FIG. 4 , in accordance with another embodiment of the present invention, a hole forming device such as coring element 40 , is placed concentrically within the lumen of the connector-conduit 32 . The coring element 40 preferably consists of a tubular structure, which could be made entirely of metal (such as stainless steel) or primarily of a plastic material with a metal insert for the leading edge 42 . In a preferred configuration, the leading edge 42 of coring element 40 may be suitably sharpened such that it cuts a plug of tissue of approximately the same diameter as the outer diameter of the coring element 40 . Note that the hole forming device can be any known mechanism for forming a hole, such as a laser cutter, a thermal ablation device, a chemical ablation device, or the like. [0106] An interference fit between connector surface 22 and the hole created by the coring element 40 is necessary to reduce bleeding from the cut myocardial surface and to reduce blood leakage from the left ventricle. The amount of such interference fit is the difference between the diameters of the hole created by the coring element 40 and the outer surface of the connector 22 . [0107] In a preferred embodiment of the device, the coring element 40 has an outer diameter that closely matches the inner diameter of the connector-conduit 32 . Such construction allows removal of the coring element 40 through the connector-conduit 32 while presenting only a small blood pathway between these two elements. Such construction is intended to minimize blood loss from the left ventricle when the coring element 40 has completed its cut. [0108] FIG. 4 further illustrates the concentric placement of the retractor element 50 within the coring element 40 . Retractor element 50 includes a blunt tip 52 , a tubular body 54 , an expanding element 56 , such as a balloon, and an access means 58 for engageably expanding element 56 . Access means 58 can be a plunger 58 a in a cylinder 58 b configuration, whereby displacement of the plunger expands or contracts expanding element 56 . A centering plug 60 is shown concentrically positioned within and rigidly attached to coring element 40 . The centering plug 60 concentrically positions retractor element 50 , which slideably moves within the centering plug 60 . The centering plug 60 also presents a barrier to the flow of blood through coring element 40 , once the tissue plug is formed. Proper placement of centering plug 60 within coring element 40 should consider tradeoffs between two different parameters. First, centering plug 60 should be placed at a position within coring element 40 , which allows ample space for the expanding element 56 and the tissue plug. Second, since radial force from the heart wall tends to deflect the expanding element 56 , retractor element 50 must have a sufficient stiffness to substantially resist such deflection. Such deflection may also be reduced by limiting the axial distance between the expanding element 56 and centering plug 60 . [0109] FIG. 5 shows a cylinder plug tool 45 for insertion into coring element 40 prior to loading connector-conduit 32 onto coring element 40 . Cylinder plug tool 45 facilitates loading connector-conduit 32 without damage from leading edge 42 of coring element 40 . Once the connector-conduit 32 is loaded, cylinder plug tool 45 is removed and placed aside. As a safety measure, cylinder plug tool 45 has an extended length with a tapered blunted end 45 a , which extends to cover retractor element 50 , preventing insertion of the retractor element 50 into the left ventricle before cylinder plug 45 is removed. [0110] Referring to FIG. 6 , another embodiment of the present invention shows a compression spring 70 placed around the retractor element 50 . One end of the compression spring 70 seats on the centering plug 60 , and the other end seats on a sliding plug 72 . Sliding plug 72 is rigidly connected to retractor element 50 . Spring 70 ensures that expanding element 56 seats snugly against the inside wall of the ventricle to symmetrically displace the ventricle wall from the path of the coring element. Once the tissue plug is cut from the ventricle by coring element 40 , spring 70 also pulls the tissue plug fully within the coring element 40 . [0111] FIG. 7 illustrates a further embodiment, wherein a cylinder-shaped pushing element 80 is positioned concentrically outside the connector-conduit element 32 . Pushing element 80 is used to apply force to the coring element 40 and connector-conduit element 32 . This force is required for the coring element 40 to cut the hole in the myocardium and for pushing the connector-conduit element 32 into the hole. The end of the pushing element 80 that is in contact with the suture ring 26 has a roughened surface 82 intended to prevent relative rotary motion between the suture ring 26 and pushing element 80 . As such, the pushing element 80 allows both a force and a back-and-forth rotary motion to simultaneously be applied to the coring element 40 and connector-conduit element 32 , as required to fully seat the suture ring 26 flush with the surface of the heart. Pushing element 80 could be made of metal, plastic or other suitable material. [0112] Referring to FIGS. 8A and 8B , a handle 90 is rigidly attached to pushing element 80 . As shown, handle 90 is configured similar to a pistol grip, for example, handle 90 having an angle of about 70 degrees, with the pushing element 80 . Handle 90 provides a user-friendly interface for the surgeon to hold with one hand, to position the coring element 40 , to apply axial force to the connector-conduit element and to provide a back-and-forth rotational motion of around 90 degrees. Of course, many alternatives exist for the user interface. For example, the pushing element 80 itself could be used as the handle. As another example, a handle could form a “T” shape on the end of the pushing element 80 . [0113] Also shown in FIG. 8A , an access means 58 is used to expand or contract expanding element 56 . Access means 58 , for example, can be a trigger-type mechanism integrated into handle 90 . As such, the user can use a finger to pull plunger 58 a into the cylinder 58 b , thereby displacing the fluid (such as saline) inside the cylinder 58 b into the balloon 56 . FIG. 8B shows the inflation of the balloon 56 . As a safety feature, the plunger can have a latching device (not shown) that latches the plunger 58 a with the balloon fully inflated, thereby preventing deflation of the balloon before intended. [0114] FIGS. 9 and 10 show a mechanism for controlling deployment of the retractor element 50 . A slot 84 is cut into pushing element 80 . Slot 84 has an index 84 a to lock retractor element 50 at full extension and an index 84 b to lock retractor element 50 at full retraction. Bolt 72 a is rigidly attached to sliding plug 72 . Bolt 72 a can be manually displaced within slot 84 to position the retractor element 50 . In operation, bolt 72 a is positioned in index 84 a until the retractor element 50 is fully inserted into the left ventricle and the expanding element 56 is at full expansion. At that time, bolt 72 a is manually released from index 84 a , which allows compression spring 70 to retract retractor element 50 until expanding element 56 contacts the inside wall of the left ventricle. A damping means (not shown) may be included to prevent sudden retraction of the retractor element upon release from index 84 a . Also not shown is a safety latch or other means to prevent manual release of the bolt 72 a until the expanding element 56 is fully expanded. [0115] As the surgeon applies force and rotation using handle 90 , compression spring 70 continues to displace retractor element 50 . When retractor element 50 is fully retracted, the surgeon can rotate bolt 72 a into index 84 b to lock the retractor element 50 in place. Moreover, when retractor element 50 is fully retracted, the expanding element 56 is also fully retracted into coring element 40 , indicating that the tissue plug has been successfully removed from the left ventricle and is within the coring element 40 . [0116] Referring to the embodiment of FIGS. 11A-11C , the connector conduit has a structural frame 101 defining a rigid portion, which may be constructed from a single material or a combination of materials. The structural frame 101 includes a tapered leading edge 110 designed to reduce the effort needed to push the connector through the heart wall located at one end of a cage section 120 and a bend portion 140 that is normally biased into a bent configuration. As shown in FIG. 11C , a tapered and beveled leading edge 150 may further reduce the required effort. During use, cage 120 resides primarily within the heart wall, so it must be constructed so as to be rigid enough to not collapse due to radial forces exerted by the heart wall. The cage 120 may include cage slots 121 . The cage slots 121 allow the passage of thread to secure the conduit or the sewing flange. [0117] A holder 130 is formed at one end of cage 120 and may be used to grasp the connector during implantation. As will be described further herein, holder 130 can have a slot-and-key configuration with the applicator. As such, the holder 130 utilizes holder slots 431 or a holder button 430 ( FIG. 12 ). Holder button 430 may be a separate part that is anchored (e.g., by thread or glue) to structural frame 101 . If desired, the holder slots 431 or holder button 430 may be designed to place the flexible bend 140 or rigid bend 145 ( FIG. 14 ) at a preferred angle relative to the applicator. Alternatively, the holder 130 may rely upon a tight friction fit with the applicator. In a preferred configuration, the holder 130 relies upon both a slot-and-key and a tight friction fit to lock the holder 130 relative to the applicator. [0118] Referring again to FIGS. 11A and 11B , bend portion 140 includes circular rings 141 and a curved spine 142 . The circular rings 141 prevent radial collapse of the conduit, and the curved spine 142 holds the conduit in a preferred shape to direct blood flow from the heart to the aorta. The curved spine 142 may be at the outer radius of bend portion 140 (as shown) or at the inner radius of the flexible bend. As an alternative, flexible bend 140 may include two curved spines at the mean radius. As another alternative, the structural frame 101 could include circular rings 141 without curved spine 142 . As another alternative, a modified coil spring in the shape of a preferred bend could be used instead of circular rings 141 and curved spine 142 . Properties of the coil spring would be chosen to prevent radial collapse and to provide appropriate stiffness of the curved position. [0119] The structural frame of FIGS. 11A-12 is intended for mounting onto the outer diameter of a straight mounting element. As such, the bend portion 140 must be constructed to allow straightening of the curved spine 142 . If curved spine 142 is made of a material or combination of materials with higher modulus of elasticity (e.g., PEEK, metal), the flexible bend 140 is stiffer. As such, the flexible bend 140 may be biased to resume a preferred shape (e.g., a 90° bend) when removed from the mounting element. If the curved spine 142 is made of a material with a lower modulus of elasticity (e.g., polypropylene, polyethylene), the bend portion 140 is less stiff. As such, the bend portion 140 may be biased relatively straight when removed from the straight mounting element. In such case, some bending means may be needed to position the bend portion 140 into the preferred shape. [0120] One embodiment of a bending means is shown in FIGS. 13A and 13B , which illustrate use of threads 143 that are secured to the holder 130 (for example) and weaved through circular rings 141 . When threads 143 are pulled, the bend portion 140 changes from the normally biased, straight configuration of FIG. 13A to the bent configuration of FIG. 13B . When the flexible bend 140 reaches the preferred shape, the threads may be tied to form a knot or crimped. If desired, the bending means can be used with a curved spine 142 constructed of a high modulus of elasticity material to prevent straightening beyond the preferred angle. [0121] As discussed previously, structural frame 101 may be constructed with a fixed bend 145 , as shown in FIG. 14 . A port 146 allows the mounting of structural frame 101 with a fixed bend 145 onto a straight mounting element. [0122] FIG. 15 is a cross-section of a connector conduit 100 that includes a rigid portion defined by structural frame 101 with bend portion 140 , and a flexible portion defined by conduit 160 . The rigid portion also includes outer fabric 161 , and sewing flange 170 . Orientation marks (not shown) may be included on the conduit 160 or outer fabric 161 . Conduit 160 may be a pleated vascular graft constructed of woven Dacron. Outer fabric 161 could be a knitted Dacron fabric material that stretches to accommodate contours of the structural frame 101 . Sewing flange 170 could be constructed of a soft silicone rubber, for example, to allow easy passage of a needle when fastening sewing flange (or sewing ring) 170 to the outer surface of the heart. To allow visualization on x-ray, for example, the sewing flange could be made radiopaque, such as by mixing barium sulfate into the silicone rubber. The sewing flange may have a cloth covering such as that used for outer fabric 161 . Alternatively, the sewing flange 170 may consist entirely of folded cloth. The components of the connector conduit 100 may be fastened together as needed, such as with thread. [0123] Referring to FIG. 16 , a cross-section of a connector conduit 100 is similar to that shown in FIG. 15 , except that the structural frame 101 is constructed with fixed bend 145 . A conduit branch 162 intersects with conduit 160 through port 146 of rigid bend 145 to allow passage of a straight mounting element through the connector conduit 100 . Once the connector conduit 100 is implanted into the ventricle, branch 162 may be occluded at the intersection with conduit 160 . Branch 162 may then be cut off. [0124] FIG. 15 and FIG. 16 further illustrate a quick connect coupler 180 for expediting attachment of the connector conduit 100 to the remainder of the prosthesis, which may include a prosthetic valve or ventricular assist device, as examples. As shown, the male end of quick connect coupler 180 is a continuation of or is attached to vascular graft 160 . The male end of quick connect coupler 180 includes rigid connector frame 181 , which may be constructed of a biocompatible plastic or metal. Vascular graft 160 covers the inner diameter of connector frame 181 , and an outer fabric 165 covers the outer diameter of connector frame 181 . Outer fabric 165 may be continuous with vascular graft 160 . Outer fabric 165 is not of a pleated construction, such as is typical of vascular graft 160 . The cloth-covered connector frame 181 provides a rigid surface onto which the female end of quick connect coupler 180 may be mounted. The female end of quick connect coupler 180 includes vascular graft 186 and pull ring 185 . Vascular graft 186 attaches on its downstream end to the remainder of the prosthesis, which may include a prosthetic valve or ventricular assist device, as examples. Vascular graft 186 may be a pleated vascular graft constructed of woven Dacron, for example. Graft extension 186 a is a continuation portion of or is attached to vascular graft 186 . A rigid pull ring 185 (which may be constructed of a biocompatible plastic or metal) is attached to graft extension 186 a . The male end of quick connect coupler 180 has a larger outer diameter than vascular graft 186 . This construction provides a stop so that the male end of quick connect coupler 180 reaches an abrupt change to a smaller diameter provided by vascular graft 186 . In this way, the surgeon knows when the male end is fully inserted into the female end of quick connect coupler 180 . In use, the surgeon may grasp pull ring 185 with one hand and connector frame segment 181 a of connector frame 181 with the other hand. Pull ring 185 is pulled over outer fabric 165 until the male end of quick connect coupler 180 contacts the smaller diameter vascular graft 186 . A large suture or umbilical tape 187 may then be tied around graft extension 186 a to reduce blood loss by occluding the annular gap between the outer diameter of outer fabric 165 and the inner diameter of graft extension 186 a . Stay sutures may also be used to connect outer fabric 165 to graft extension 186 a , thereby preventing separation of the male and female ends of quick connect coupler 180 . [0125] FIG. 15 and FIG. 16 further illustrate a collapsible portion 160 a between connector conduit 100 and quick connect coupler 180 . Such collapsible portion 160 a allows use of a cross clamp, for example, to fully collapse portion 160 a to occlude flow after the applicator is removed beyond collapsible portion 160 a . Collapsible portion 160 a can be made of the same material as the rest of the flexible portion, or can be made of a different material. [0126] In use, the applicator of the present invention is used to implant the connector conduit 100 into the ventricle wall or other organ wall. FIG. 17A shows a cross-section of the connector conduit 100 ( FIG. 15 ) loaded onto a mounting element 200 . For clarity, the applicator is shown without the connector conduit 100 in FIG. 17B . Mounting element 200 includes a cylindrical coring element 210 , serving as a hole forming element, that is concentric with and has the same diameter as the mounting element 200 . The mounting element 200 and coring element 210 are placed concentrically within the lumen of the connector conduit 100 . Coring element 210 includes a thin-walled tube and a sharpened cutting edge 210 a , which may be tapered on the inner diameter, for example, to form the sharpened cutting edge 210 a . The coring element 210 is used to cut a cylindrical-shaped core (or hole) in the heart wall, producing a plug from the heart wall that resides within the coring element 210 . The mounting element 200 could be constructed of plastic (e.g., ABS), and the coring element 210 could be constructed of metal (e.g., stainless steel). In a preferred embodiment, the mounting element 200 and coring element 210 have an outer diameter that closely matches the inner diameter of the connector conduit 100 . One purpose of such a construction is to minimize blood loss from the left ventricular chamber when the coring element 210 has completed its cut. Also in order to reduce blood loss from the left ventricular chamber and from the cut myocardial surface and to yield a snug fit of the connector conduit within the ventricular myocardium, the cutting diameter of the coring element 210 is chosen to produce a core that is smaller in diameter than the outer surface 163 of the of the connector conduit 100 . [0127] FIG. 17A and FIG. 17B further illustrate a cylinder-shaped pushing element 300 positioned concentrically outside the connector conduit 100 . In a preferred embodiment, the pushing element 300 transmits pushing force and rotation to the connector conduit 100 . In further accordance with a preferred embodiment, the pushing element 300 is rigidly attached to mounting element 200 , such that pushing element 300 transmits pushing force and rotation to the mounting element 200 and coring element 210 . Pushing element 300 may be constructed of plastic (e.g., ABS) or metal (e.g., stainless steel). However, it should be appreciated that the present invention contemplates the use of other materials. [0128] In further accordance with a preferred embodiment, a locking means provides an interface that prevents movement of the connector conduit 100 relative to the pushing element 300 . Such locking means may include components that are integral with the pushing element 300 , connector conduit 100 , mounting element 200 , and coring element 210 . FIGS. 18A to 18C illustrate one embodiment of such a locking means. This embodiment combines a slot-and-key arrangement with a friction enhancing arrangement. The slot-and-key arrangement includes notch 421 (the slot) of pushing element 300 and holder button 430 (the key) of structural frame 101 . Positioning holder button 430 into notch 421 prevents rotation of connector conduit 100 relative to pushing element 300 and prevents axial motion in one direction. Axial motion allowing removal of the connector conduit 100 from the applicator is not prevented in this embodiment. Rather, this axial motion is reduced by providing a friction enhancing arrangement consisting of squeeze ring 410 (which includes two groove pins 411 ) and squeeze arms 425 a and 425 b that cantilever from pushing element 300 to form wide groove 420 a and narrow groove 420 b . Alternatively, notch 421 could fit tightly around the circumference of holder button 430 to prevent movement of the connector conduit 100 relative to the pushing element 300 in both rotational and axial directions. As shown, notch 421 is divided, with one half cut from squeeze arm 425 a and the other half from squeeze arm 425 b . Alternatively, notch 421 could reside entirely within either squeeze arm. Alternatively, several notches 421 could be used. [0129] When squeeze ring 410 is positioned at or near notch 421 as shown in FIG. 18B , squeeze ring 410 holds squeeze arms 425 a and 425 b tightly against connector conduit 100 , creating a tight friction fit. In this position, groove pins 411 within wide groove 420 a do not tend to separate squeeze arms 425 a and 425 b . When squeeze ring 410 is positioned as shown in FIG. 18C , groove pins 411 within narrow groove 420 b tend to separate squeeze arm 425 a and 425 b to allow the connector conduit to be easily moved into position or removed. In a similar embodiment (not shown), the slot-and-key arrangement could include teeth (keys) that extend radially inwards from the inner diameter of squeeze arms 425 a and 425 b to fit into holder slots 431 of holder 130 of structural frame 101 (see FIG. 11A ). In this embodiment, a squeeze ring (with groove pins) and squeeze arms similar to those shown in FIGS. 18A to 18C would be used to engage and disengage the teeth from holder slots 431 , rather than to provide a tight friction fit. [0130] In accordance with a further embodiment of the present invention, a retractor component element 500 with a generally tubular structure is located concentrically within the mounting element 200 , as shown in FIG. 19 . The retractor element 500 can slide axially relative to the mounting element 200 . The retractor element 500 consists of a blunt tip 510 , a tubular body 520 , and an expanding element 530 that includes an access passage 531 . The expanding element 530 is shown as a balloon in FIG. 19 , which may be inflated and deflated with fluid (e.g., saline) through access passage 531 using a plunger and cylinder arrangement. [0131] Retractor element 500 is held concentric within the mounting element 200 by centering plug 220 and sliding plug 521 . Centering plug 220 is rigidly attached to mounting element 200 , and sliding plug 521 is rigidly attached to tubular body 520 . Since radial force from the heart wall tends to deflect the expanding element 530 , tubular body 520 must have a sufficient stiffness to substantially resist such deflection. Such deflection may also be reduced by limiting the axial distance between the expanding element 530 and centering plug 220 . [0132] A coupling element, such as compression spring 540 , slideably couples retractor element 500 to mounting element 200 . Compression spring 540 biases refractor element proximally to ensure that expanding element 530 seats snugly against the inside wall of the ventricle to shape and partially flatten the ventricle wall (particularly at the apex) so that coring element 210 may cut perpendicular to the ventricle wall. Once the tissue plug is cut from the ventricle by coring element 210 , spring 540 pulls the tissue plug fully within the coring element 210 . In the preferred embodiment, expanding element 530 is a balloon in the shape of a circular torrid. [0133] FIG. 20 illustrates a mounting and folding tool 900 , which includes coring element taper 910 , balloon taper 920 , conduit taper 930 , and retractor element port 940 . Tool 900 's outer diameter may be equal to or slightly larger than coring element 210 's outer diameter to prevent damage to fabrics of the vascular graft 160 and outer fabric 161 , when the connector conduit 100 is being mounted onto or demounted from mounting element 200 . As an alternative, a thin-walled tube, such as a plastic shrink rube, may be positioned over outer diameters of tool 900 and coring element 210 to further prevent damage to fabrics slid past the sharpened edge 210 a of the coring element. Coring element taper 910 fits snugly within coring element 210 to ensure a concentric fit between tool 900 and coring element 210 , thereby further reducing the likelihood of damage to vascular graft 160 and outer fabric 161 . Conduit taper 930 eases placement of vascular graft 160 onto tool 900 . Tool 900 may be used to deflate and fold expanding element 530 by placing tool 900 onto retractor element 500 and by pushing and rotating (in one direction) tool 900 until coring element taper 910 contacts coring element 210 . Balloon taper 920 provides a surface for controlled deflation and folding of the expanding element 530 . Once the balloon is deflated and folded and the connector conduit 100 is fully mounted onto the applicator, tool 900 may be removed. [0134] FIG. 21 illustrates an embodiment of an applicator assembly (connector conduit 100 not shown). In this assembly, the surgeon has independent control of the position of retractor element 500 and the volume of expanding element 530 . Handle 310 , which extends from pushing element 300 to form a pistol grip, provides a means for the surgeon to apply axial force and back-and-forth rotary motion while implanting connector conduit 100 . The position of retractor element 500 is controlled by the position of retractor bolt 522 in slot 320 of pushing element 300 . Retractor bolt 522 is rigidly attached to sliding plug 521 of retractor element 500 . Slot 320 is extended circumferentially to form index 321 , which may be used to hold the retractor element 500 fully extended (i.e., with expanding element 530 at maximum distance from coring element 210 ). Expanding element 530 is connected to cylinder 562 by access passage 531 and flexible tube 550 . Expanding element 530 volume is controlled by the position of plunger 600 in cylinder 562 . Cylinder 562 is oriented in handle 310 so that plunger 600 with trigger 563 forms a pistol handle with trigger arrangement. Expanding element 530 can be inflated with saline, when trigger 563 is squeezed. Plunger spring 565 may be used to deflate expanding element 530 when the trigger is released. Alternatively, trigger 563 could be replaced with a finger ring so that the user must apply force to control both inflation and deflation of expanding element 530 , thereby eliminating the need for plunger spring 565 . As a safety feature, the plunger 600 may include a latching device (not shown) that latches the plunger 600 with the balloon fully inflated, thereby preventing premature deflation of the balloon. A related safety feature may include another latching device (not shown) that latches plunger 600 with the balloon partially inflated, such as to prevent the tissue plug from coming off of retractor element 500 . As one of many alternatives to handle 310 , the handle could form a “T” with pushing element 300 . [0135] In operation, retractor bolt 522 is positioned in index 321 until the retractor element 500 is fully inserted into the ventricle and expanding element 530 is fully inflated. At that time, retractor bolt 522 is manually released from index 321 , which allows compression spring 540 to retract retractor element 500 until expanding element 530 contacts the inside wall of the ventricle. A damping means (not shown) may be included to prevent sudden retraction of the retractor element 500 upon release from index 321 . Also not shown is a safety latch or other means to prevent manual release of the retractor bolt 522 until the expanding element 530 is fully expanded. As the surgeon applies force and rotation using handle 310 , compression spring 540 continues to displace retractor element 500 . When retractor element 500 is fully retracted, expanding element 530 is also fully retracted to within coring element 210 , indicating that the tissue plug has been successfully removed from the left ventricle and is within the coring element 210 . [0136] FIG. 22A to FIG. 22C are components of a preferred embodiment shown in FIGS. 24A-24E , that uses a sequencing element to coordinate the position of refractor element 500 with the expansion of expanding element 530 ( FIG. 22B ). In this embodiment, the sequencing element is a cam mechanism. The cam mechanism helps to ensure proper use of the applicator during implantation of connector conduit 100 (not shown). As shown in FIG. 22B , retractor element 500 , referred to as the retractor assembly, includes cylinder portion 562 integrated therein. The retractor assembly is positioned concentrically within pushing element 300 during use. The retractor assembly contains elements of the cam mechanism formal therein, including cylinder cam slot 710 , which is a slot cut completely through the cylinder 562 wall, and a refractor cam follower 760 , which may be a pin or screw in cylinder 562 (as shown) or may be an integral part of cylinder 562 . Retractor element 500 may include a section of increased diameter such as stopper disk 515 to prevent cutter element 210 from cutting the heart when retractor element 500 is initially inserted. FIG. 22A illustrates plunger 600 (in the form of a sequencing bolt as described below), which is positioned concentrically within cylinder 562 during use. Plunger 600 contains elements of the cam mechanism, including bolt portion 650 with plunger cam follower 750 . Plunger cam follower 750 moves within cylinder cam slot 710 and pusher cam slot 720 . Plunger 600 includes passage 610 and purge/fill valve 630 (valve body not shown). Valve 630 can be opened to allow fluid flow into and out of passage 610 . When closed, valve 630 allows no fluid flow in either direction. Valve 630 may be connected (such as with a catheter) to a reservoir of saline, for example, to purge the expanding element 530 , access passage 531 and any other volume in the flow circuit of air before filling these volumes with fluid (such as saline). O-ring groove 620 of plunger 600 contains an o-ring (not shown) to prevent loss of fluid. [0137] FIG. 22C illustrates a positioning assembly, which is made up of rigidly connected components including pushing element 300 , cutting element 210 , and handle 310 . The pusher assembly contains elements of the cam mechanism, including pusher cam slot 720 and retractor cam slot 730 . The pusher cam slot 720 is a slot cut completely through the pushing element 300 wall to accommodate plunger cam follower 750 . [0138] FIG. 23A to FIG. 23C illustrate operation of the cam mechanism. FIG. 23A illustrates cylinder cam slot 710 cut into cylinder 562 of FIG. 22B . Cylinder cam slot 710 contains three interconnected axial cam slots at angles 1 , 2 and 3 around the circumference of cylinder 562 , as further illustrated in FIG. 23C . The axial cam slot at each angle corresponds to a range of allowable axial positions of plunger 600 within cylinder 562 . At angle 1 , the axial length of the cam slot corresponds to the maximum stroke of plunger 600 within cylinder 562 . This maximum stroke allows filling the expanding element 530 from minimum volume to maximum volume. At angle 2 , the axial cam slot allows plunger 600 movement to provide expanding element 530 volumes ranging from maximum volume to an intermediate volume (at an intermediate stroke) that is greater than minimum volume but less than maximum volume. At angle 3 , the axial cam slot retains plunger 600 at the position of maximum volume of the expanding element 530 . FIG. 23A also illustrates positions A, B, C, D and E of plunger cam follower 750 within cylinder cam slot 710 during the steps of operation. [0139] FIG. 23B illustrates pusher cam slot 720 and retractor cam slot 730 cut into the pusher assembly of FIG. 22C . FIG. 23B also illustrates positions A, B, C, D and E of plunger cam follower 750 within pusher cam slot 720 and retractor cam follower 760 within retractor cam slot 730 during the steps of operation. FIG. 23C illustrates angles 1 to 6 for cylinder 562 and the pusher assembly. For purposes of description, the value of the angles increases from 1 to 6 . Pusher cam slot 720 includes angles 1 and 3 , which may correspond with angles 1 and 3 of cylinder 562 (see FIG. 23A ). Pusher cam slot 720 includes angle 4 , which is larger than 3 . The axial length of pusher cam slot 720 from position A to position B corresponds to the maximum stroke of the plunger 600 , as described above. The axial length of pusher cam slot 720 from position C to position E corresponds to the intermediate stroke (as described above) plus the axial distance traversed by retractor cam follower 760 from position C to position E in retractor cam slot 730 . Retractor cam slot 730 includes angles 5 and 6 . Positions A and B at angle 5 prevent compression spring 540 from displacing cylinder 562 within the pusher assembly. [0140] In operation, retractor cam slot 730 controls the motion of cylinder 562 within the pusher assembly. As shown in FIG. 23A and FIG. 23B , when plunger cam follower 750 (of sequencing bolt 600 ) is moved circumferentially from position B to position C in both cylinder cam slot 710 and pusher cam slot 720 , retractor earn follower 760 is forced from position B to position C in retractor cam slot 730 , which allows compression spring 540 (see FIG. 19 ) to push cylinder 562 axially within the pusher assembly. Retractor cam follower 760 within retractor cam slot 730 holds cylinder 562 at a constant angular position relative to the pusher assembly during movement from position C to positions D and E; therefore, movement of plunger cam follower 750 from position C to position D within pusher cam slot 720 forces cam follower 750 into the axial slot corresponding to angle 2 of cylinder 562 . [0141] Referring to FIGS. 24A to 24E , the applicator of the present invention is shown at various steps during use. Note that these figures do not include details of the locking means to securely hold the connector conduit 100 . FIG. 24A to FIG. 24E correspond to positions A to E, respectively, which are described in FIG. 23A to FIG. 23C . Recognizing that individual surgeons may find alternative steps to properly use the invention, a representative sequence of steps for use of the applicator to implant a connector conduit is described. These steps include first preparing the applicator with the connector conduit. With the retractor assembly in the fully extended position as shown in FIG. 24A , a mounting and folding tool 900 is positioned into the coring element 210 , as shown in FIG. 20 . The connector conduit 100 of FIG. 15 is then loaded into the applicator by sliding connector conduit 100 over the folding tool 900 until sewing flange 170 contacts notch 421 (see FIG. 18 ). The connector conduit is then locked into place using the locking means. Tool 900 is then removed. A catheter is attached to purge/fill valve 630 and to a reservoir of saline. Valve 630 is opened. Sequencing bolt 600 is then moved back and forth from position A to position B several times to purge the fluid system of air and to fill the system with fluid, such as saline. Once the air is purged, sequencing bolt 600 is placed at position A, and tool 900 is again positioned into the coring element 210 —this time to squeeze fluid from the balloon and to fold the balloon. When tool 900 is in place, valve 630 is closed, and the catheter is removed. Tool 900 is removed. The applicator with connector conduit is now ready for use, as shown in FIG. 24A . [0142] Before implanting the connector conduit 100 into the ventricle wall, the portion of the prosthesis that includes the prosthetic valve or ventricular assist device, as examples, is connected to the aorta. This portion of the prosthesis also includes the female end of quick connect coupler 180 . By implanting this portion of the prosthesis first, the time between insulting the heart by cutting a hole and beginning blood flow through the complete prosthesis is minimized. [0143] A template with similar dimensions as connector conduit 100 is placed on the apex of the heart, and a marker is used to trace the circular outline of the connector onto the apex, in the planned location of insertion. Multiple (8 to 12) large pledgeted sutures (mattress sutures) of for example, 2-0 prolene, are placed in the apex surrounding the marked circle. With the connector conduit 100 loaded in the applicator of FIG. 24A , the sutures are brought through sewing flange 170 of the connector conduit 100 . A knife is used to make a stab wound in the apex at the center of the circle. With the applicator in the position shown in FIG. 24A , blunt tip 510 of retractor element 500 is inserted into the stab wound and pushed through the apex into the left ventricle chamber until stopper disk 515 contacts the epicardium (outside surface of the heart). Sequencing bolt 600 is moved from position A to position B to inflate the balloon behind tissue T of the heart wall (see FIG. 24B ). The surgeon moves sequencing bolt 600 from position B to position C (see FIG. 24C ) and then releases sequencing bolt 650 . Beginning at position C of FIG. 24C , compression spring 540 pushes the retractor assembly from position C to position D (see FIG. 24D ). When the retractor assembly moves from position C to position D, tissue T of the heart wall is first sandwiched between the balloon and the sharpened edge of the coring element 210 a . By the surgeon using handle 310 to apply axial force and back-and-forth rotary motion, the sharpened edge of the coring element 210 a cuts though the heart wall to form a plug of tissue T that resides in the coring element 210 . At position D, the retractor assembly has been retracted until the balloon is in contact with coring element 210 and the tissue plug is fully within coring element 210 . Also at position D, cylinder cam slot 710 has forced plunger cam follower 750 circumferentially to angle 2 , thereby allowing deflation of the balloon to begin. Between position D ( FIG. 24D ) and position E ( FIG. 24E ), the balloon deflates to the intermediate volume (described earlier), and the retractor assembly retracts to its final position. If necessary, the surgeon may pull sequencing bolt 600 to its final position E. [0144] Connector conduit 100 is now fully implanted. The sutures are tied, and hemostasis is checked. Additional sutures may be placed if needed. The locking means (not shown) holding the connector conduit in the applicator is released, and the applicator is partially removed to a position where a clamp can be placed directly on collapsible graft 160 a to prevent blood flow through the conduit 160 . Once the clamp is in place, the applicator may be completely removed from connector conduit 100 . The male and female ends of quick connect coupler 180 may now be connected. Umbilical tape 187 may be tied around graft extension 186 a to reduce any blood leakage, and stay sutures may be used to secure graft extension 186 a to outer fabric 165 . Once the flow passage of the prosthesis is purged of air, the clamp may be released to allow blood flow through the prosthesis. Flexible bend 140 is formed by pulling threads 143 and tying a knot. The connector conduit 100 is now fully implanted. [0145] As illustrated in FIG. 27 , an alternative embodiment, can use a connector conduit having and integral hole forming element. Hole forming element 21 ′ is integrally formed, i.e. formed as a single component, with respect to connector conduit 100 ′. Connector conduit 100 ′ can be loaded on an applicator (not having a separate hole forming element) in a manner similar to that disclosed above. After forming the hole and inserting the connector conduit into the hole, hole forming element 210 ′ can be withdrawn into a distal end of connector conduit 100 ′, as illustrated in FIG. 26 , to reduce the possibility of unintended tissue damage. Such withdrawal can be accomplished by the sequencing means, a manual mechanism on the applicator, or with a separate instrument. [0146] In the preferred embodiment described above, the expansion element is a balloon. However, an alternative expansion element, in the form of an umbrella mechanism, is illustrated in FIGS. 27A-27D . Retractor 500 ′ includes cylinder 810 (shown in cross section), and piston element 820 slideably disposed in cylinder 810 . Bolt 650 having follower 750 is formed on cylinder 810 . Shaft 830 extends from piston element 820 and has umbrella mechanism 850 formed on an end thereof. Umbrella mechanism 85 included plural bendable leaf elements 852 that are fixed to shaft 830 at the end of shaft 830 . Leaf elements 852 are fixed to ring 854 at the other end thereof. Ring 854 is slideably disposed on shaft 830 . Accordingly, movement of shaft 830 to the right in the FIGS. causes ring 854 to be pushed toward the end of shaft 830 as ring 854 abuts an end of cylinder 810 , as shown in FIG. 27 D. Slot 710 guides follower 750 , ad bolt 650 cooperates with remaining elements in the sequencing mechanism in the manner described above, to coordinate the expansion state of expansion element 850 . [0147] Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.

1a

This is a divisional of application Ser. No. 08/630,000, filed 08 Apr. 1996, now U.S. Pat. No. 5,669,096. BACKGROUND OF THE INVENTION 1. Field Of The Invention The invention herein pertains to the cleaning of "dry" pool balls as are used by children for recreational purposes. The system of the invention utilizes a ball washer which provides a negative pressure for drawing balls thereto and a positive pressure for exiting balls therefrom. A converger allows a single ball washer to handle a plurality of ball pools and a diverter redirects the balls from the washer selectively back to the plurality of ball pools. 2. Description Of The Prior Art And Objectives Of The Invention The use of "dry" pools which are filled with lightweight plastic balls for play purposes by children has become increasingly popular in recent years. Such installations are available at fast food restaurants, playgrounds and other areas frequented by children. However, such ball pools can become unsanitary and as a result, pool owners must constantly remove the balls for cleaning and sterilization purposes. Ball cleaning machines have often replaced other methods of cleaning but certain ball cleaning machines still require manual handling and high labor expenses for the owner. U.S. Pat. Nos. 5,373,597 and 5,454,877 demonstrate apparatus for cleaning balls by transporting balls manually from "dry" pools to cleaning machines. However, such operations, although effective, require much labor in the transportation and delivery and, therefore, lessens the operator's ability and desire to clean the balls frequently. There has thus been a need for a way to easily, automatically clean the pool balls in a fast, efficient manner with minimum manual labor. Certain prior ball cleaning systems have used ball tracks formed from plastic rods which are bent to desired shapes and configurations. Thus, with the known disadvantages and problems associated with prior ball cleaning systems and devices, it is one objective of the present invention to provide a pool ball cleaning system which is relatively labor free yet which will clean a large quantity of pool balls in a short period of time. It is still another objective of the present invention to provide a ball cleaning system which utilizes negative pressure from the ball washer to move the balls to the brush compartment of the ball washer for cleaning purposes. It is yet another objective of the present invention to provide a ball washer which includes a simple bad ball detector for removing damaged balls. It is still another objective of the present invention to provide a ball washer which includes a venturi for applying a positive pressure to the balls exiting the ball washer. It is yet another objective of the present invention to provide a converger which allows selective removal of soiled balls from one or more ball pools. It is yet a further objective of the present invention to provide a diverter for selective replacement of cleaned balls into one of a plurality of ball pools. A further objective of the present invention is to provide a ball track which is relatively simple to manufacture and which can be adjustably lengthened or shortened to a variety of sizes and can be formed in either straight or curved configurations. Various other objectives and advantages of the present invention will become apparent to those skilled in the art as a more detailed description is set forth below. SUMMARY OF THE INVENTION A children's play pool ball cleaning system is described setting forth the aforesaid objectives and advantages to provide a fast, easy and convenient manner of cleaning pool balls which become soiled from a series of pools. The ball system includes tubing attached to a ball washer which provides negative pressure for delivering balls to the washer. Such tubing is used to collect balls from the ball pools and is also used to direct the clean balls upwardly from the ball washer to a sufficient height. A diverter is then used to return the balls to a certain one of a selected number of ball pools as desired. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a schematic ball cleaning system utilizing a pair of ball pools; FIG. 2 demonstrates a perspective view of a ball washer with the side panels removed to expose the internal components; FIG. 3 shows a schematic side representation of the ball washer as seen in FIG. 2; FIG. 4 features a schematic enlarged view of the ball detector as used with the ball washer of FIG. 3; FIGS. 5 and 12 depict schematic top representations of the diverter illustrating use of different ball outlets; FIG. 13 illustrates an end view of the ball outlet as shown along lines 13--13 of FIG. 12; FIG. 6 depicts a schematic side elevational view of the diverter as shown in FIGS. 5 and 12; FIG. 7 shows a side elevational view of a typical linear track assembly; FIG. 8 demonstrates a fragmented track assembly as joined to a similar fragmented track assembly as seen in FIG. 7. FIG. 9 pictures an end view of the track assembly as seen in FIG. 7 along lines 9--9; FIG. 10 features another track assembly having a curved configuration; and FIG. 11 provides a perspective view of the converger as used in the ball cleaning system with the top cover cut away for clarity. DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred form of the ball cleaning system is shown schematically in block fashion in FIG. 1 and includes a pair of separated ball pools for use by children. Both pools are connected by tubing to a converger which is negatively pressurized from the ball washer. Soiled balls which move from the pools are cleaned by the ball washer and are then vertically elevated under positive pressure to a diverter. From the diverter the balls roll along tracks by gravity where they are returned in clean, fresh condition to the ball pools. The preferred converger is illustrated in FIG. 11 and includes a pair of ball inlets and a single ball outlet for delivery of balls to the ball washer. The preferred ball washer of the invention is best shown in FIGS. 2 and 3 and includes a sealed brush compartment which exerts a negative pressure on a ball detector. Positive pressure is exerted on a venturi therein by a fan contained within the ball washer cabinet. The balls are directed mechanically from the sealed washing compartment under negative pressure to the venturi, then under positive pressure to the drying chamber and then to a diverter for distribution to a pair of ball pools once they exit the diverter. The preferred form of the diverter is illustrated in FIGS. 5, 12, and 13, and includes a movable gate controlled by a pair of solenoids linked thereto. The preferred track assembly of the invention is shown in FIG. 8 whereby a plurality of cylindrically shaped rods are joined to circular metal rod guides. Straight or curved track assembly can be joined together by bolts positioned through apertures in the rod guides to form a track assembly of desired length and configuration. DETAILED DESCRIPTION OF THE INVENTION AND ITS OPERATION For a better understanding of the invention and its use, turning now to the drawings, FIG. 1 demonstrates a schematic view of a typical "play pool" ball cleaning system 10, which includes a pair of ball pools, 11, 11'. Pools 11, 11' can be any of a variety of sizes filled with lightweight plastic pool balls 12 which may range from approximately 73-82 mm in diameter. Different diameter balls can be mixed within the system within the 73-82 mm range without concern. Playgrounds, fast-food restaurants, and children's entertainment centers typically utilize play pools filled with lightweight balls 12 for children's fun and enjoyment. For sanitary and health purposes, balls 12 must frequently be cleaned by the pool owners and operators. As further shown in FIG. 1, converger 14 is in communication with ball washer 15 by means of plastic tubing 17. Ball washer 15 applies negative pressure to tubing 17, through converge 14, and to tubing 18 and 19 as also shown in FIG. 1. Such negative pressure urges balls 12 from ball pools 11, 11' to converger 14 and on to ball washer 15 for cleaning purposes. After cleaning, balls 12 are generally directed upwardly, through tubing 20 under positive pressure from ball washer 15, to a convenient, desired height, which may be 2.5-3.5 meters or more, where they are then, either by gravity or, optionally, by continued positive pressure, delivered to diverter 25, after which balls 12 are gravity driven along tracks 30, 30' to the selected ball pool, 11 or 11'. As would be understood, in a system with only one ball pool utilized, converger 14 and diverter 25 would not be necessary as balls 12 would move from the ball pool to washer 15 in a simple, single path and return in a single path. Also, ball washer 15 as described herein has a single cleaning path and compartment; however, other ball washers could be utilized with multiple cleaning paths (multiple cleaning compartments) whereby additional ball pools, convergers, diverters, tubing, and track assemblies could be utilized for multiple, large scale operations. Track 30 provides a return for ball pool 11 whereas track 30' returns balls to ball pool 11'. As seen and understood, tracks 30, 30' operate by gravity to allow balls 12 to roll from diverter 25 to ball pools 11, 11', whereas tubing 17, 18, and 19 operate under negative pressure. Tubing 20 operates under positive pressure. Ball washer 15 is shown in FIG. 2 with its outer panels such as side panels 35, 36 which are formed from thin sheet metal, as seen in FIG. 3, removed to expose the inner components. Ball washer 15 includes ball detector 40 which receives incoming balls 12 as will be hereinafter more fully explained. Ball detector 40 is joined to converger 14 as seen in FIG. 1 by tubing 17 which is under a negative pressure generated by fan 41. Drying chamber 53 allows any excess water to be removed from balls 12 as they exit venturi 50. Fan 41 is a centrifugal fan driven by an electric motor 42. Motor 42 is controlled by electrical circuitry (not seen) within control box 43 attached to ball washer metal cabinet frame 44 which includes circuit breakers, on/off switches, power supply lines, circuit lights, and conventional electrical circuits. As fan 41 operates, conduit 45, which is in fluid communication with sealed brush compartment 46, allows fan 41 to pull air from brush compartment 46 and from ball detector 40. Conduit 47 allows communication between brush compartment 46 and sealed ball detector 40. (Sealed as used herein refers to the prevention of undue leakage of the hermetic type.) Thus, fan 41 provides negative pressure to brush compartment 46 and detector 40 to urge balls 12 into brush compartment 46 such as from converger 14. Once balls 12 have been washed and rinsed within brush compartment 46, they are mechanically directed, while under negative pressure, by the force of the rotating brush through venturi 50 which receives high velocity air through venturi conduit 51 from fan outlet 52 (shown in FIG. 2) to apply a positive pressure to venturi 50, thereby forcing balls 12 upwardly to drying chamber 53 and on to (typically) diverter 25 as shown in FIG. 1. Venturi 50 receives high air velocity through conduit 51 which forces balls 12 upwardly as shown in FIG. 1. In FIG. 3 also, balls 12 enter ball detector 40 and move through ball chute 49. Ball chute 49 is formed from a series of exact spaced rods (spaced to contain the particular diameter balls utilized) shown schematically without side rods which, in the event ball 12 is bent or damaged, (balls 12') fall through chute 49 due to their lessened diameter, where they can be later collected as needed by opening hinged door 60 by manually pulling knob 62 (FIG. 4) as shown. Divider 48 forms a collection area for damaged balls 12'. Thereafter, balls 12 move through conduit 47 and pass to brush 55 where they travel in a circular cleaning path and exit through venturi 50 as aforedescribed. While balls 12 are cleaned by brush 55, sprayer 99 directs a mist thereto. As previously explained, balls 12 traveling through venturi 50 are directed generally upwardly through drying chamber 53 and through conduit 20 (FIG. 1) to diverter 25, as seen in FIGS. 5 and 12. Diverter 25, as shown without the top track member or rod in FIG. 5, consists of single ball inlet 70 and a pair of ball outlets 71, 71'. Typically, diverter 25 would include track members 72, 72', 73, 73', and 74, 74' consisting of cylindrical rods shaped to allow balls 12 to roll thereon. In order to control the direction of ball 12 to a desired outlet (71, 71'), diverter 25 utilizes solenoids 77, 77' which control the movement of gate 78. As seen in FIG. 6, gate 78 is attached to pivot post 79 which in turn is joined to pivot plate 80. Plate 80 rotates around pivot post 79 by the movements of solenoids 77 and 77' through linkages, 81, 81'. Thus, incoming balls 12 passing through inlet 70 can be diverted either through outlet 71 or outlet 71' by the movement of gate 78 which is electrically controlled by a switch (not shown) attached to electric circuitry within control box 43. In FIG. 12, also shown without the top rod, gate 78 is turned so as to direct balls 12 through outlet 71' whereas in FIG. 5, gate 78 is turned so as to direct balls 12 through outlet 71'. An end view of outlet 71 along 13--13 of FIG. 12 is seen in FIG. 13, which also shows top rod 75 and a side view of diverter 25 is seen in FIG. 1. Outlets 71 and 71' are connected to a track assembly such as track assembly 100 as shown in FIG. 7. Track assembly 100 utilizes four cylindrically shaped metal rods 102 formed from aluminum, steel, or the like, and are attached along the inner circumference of rod guides 101, 101' such as by welding as seen in FIG. 9. Rods 102 may be, for example, approximately 65 cms in length, and assembly 100 can be bolted to other track assemblies, as shown loosened in FIG. 8, by bolts 103 passing though openings 105 as shown in FIG. 9 to form tracks 30, 30' of FIG. 1. To maintain the structural integrity of the track assemblies when using longer rods, additional rod guides 101 may be attached at approximate 65 cm intervals along the rods as needed. A curved track assembly 107 is shown in FIG. 10 and, of course, other shapes and configurations can likewise be formed. As would be understood, various size balls 12 can be used with track assembly 100, for example within the 70-85 mm diameter range. Rod guides 101, 101' are formed typically from 14 gauge sheet metal whereas rods 102 are formed from number 3 gauge wire. As earlier discussed, used and soiled balls 12 are directed from, typically, ball pools 11, 11' through tubing 18, 19 to converger 14. Tubing 18, 19 may be a transparent polymeric tubing such as acetate butyrate which is smooth and suitable for ball 12 movement therethrough. Typical tubing may have a 90 mm inside diameter and be of a transparent or opaque polymeric material such as acetate butyrate or other suitable plastics such as acrylics or polycarbonates. In FIG. 11, converger 14 includes metal housing 151 which may be formed from thin gauge sheet metal or the like. Flexible tubing 152 is dimensioned to pass balls 12 therethrough with ease and convenience. Typically, converger inlets 153 and 153' are in communication with ball pools such as ball pools 11, 11' by means of polymeric tubing 18, 19 as seen in FIG. 1. Contained within housing 151 proximate inlets 153, 153' is conventional linear actuator 154. Actuator 154 is joined to tubing flange 155 and moves within housing 151 from inlet 153 to inlet 153'. Tubing flange 155 is driven by linear actuator 154 along rotating elongated member 156. As further shown in FIG. 11, fractional electric horsepower motor 157 which is controlled through electrical control box 43, as seen in FIG. 2, rotates to turn belt 158 in either of a selected clockwise or counterclockwise direction. Belt 158 is joined to pulley 159 which is fastened to elongated member 156. Thus, as motor 157 turns, bearings 169 rotate to trace a helix pattern causing activator 154 to move along elongated member 156. Flange 155, with outlet tube 152 affixed, is therefore moved to either of the selected inlets 153 or 153' to receive balls 12 therethrough and discharges them through outlet 160 which is joined to tubing 17 as seen in FIG. 1. The illustrations and examples provided herein are for explanatory purposes and are not intended to limit the scope of the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATION(S) This application is a continuation-in-part of U.S. patent application Ser. No. 10/907,134, filed Mar. 22, 2005. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an onboard apparatus for suppressing a fire involving an automotive vehicle. 2. Disclosure Information Police vehicles are subject to increased exposure to collisions, particularly high-speed rear-end collisions, arising from the need for police officers to stop on the shoulders, or even in the traffic lanes, of busy highways. Unfortunately, other motorists are known to collide with police vehicles employed in this manner. These accidents can compromise the fuel system on any vehicle and may cause fires. The present system is designed to suppress the spread of, or potentially, to extinguish such a fire. U.S. Pat. No. 5,590,718, discloses an anti-fire system for vehicles in which a number of fixed nozzles are furnished with a fire extinguishing agent in response to an impact sensor. The system of the ‘718 patent suffers from a problem in that the release of the extinguishing agent is triggered immediately upon receipt of a significant impact. As a result, the anti-fire agent may be expended before the vehicle comes to a halt, with the further result being that a subsequent fire might not be treated by the system. Also, the ‘718 patent uses a valving system which could become clogged and therefore inoperable. U.S. Pat. No. 5,918,681 discloses a system which is similar to that disclosed in the ‘718 patent, inasmuch as the fire extinguishing system does not take into account movement of the vehicle following subjection of the vehicle to an impact. Finally, U.S. Pat. No. 5,762,145 discloses a fuel tank fire protection device including a powdered extinguishing agent panel attached to the fuel tank. In general, powder delivery systems are designed to prevent ignition of fires and are deployed upon impact. As a result, the powder may not be able to follow the post-impact movement of the struck vehicle and may not be able to prevent the delayed ignition or re-ignition of a fire. The present fire suppression system provides significant advantages, as compared with prior art vehicular fire suppression systems. SUMMARY OF THE INVENTION An automotive vehicle according to the present invention includes a vehicle body and at least one reservoir containing a fire suppressant agent. The reservoir containing a fire suppression agent is mounted in proximity to the body, preferably within the body or on an external surface of the body. A sensor system determines whether the vehicle has been subjected to an impact and also whether the vehicle is moving subsequent to such an impact. A distribution system receives the fire suppressant agent from the reservoir and conducts the fire suppressant agent to at least one location about the body, either internally or externally thereto. Finally, a controller operatively connected with the sensor system and the reservoir causes the reservoir to initiate delivery of the fire suppressant agent from the reservoir through the distribution system in the event that a significant impact having a suitable magnitude, duration, and other characteristics, is sensed. According to another aspect of the present invention, the fire suppressant reservoir includes a tank for the suppressant agent and a propellant for establishing pressure within the tank sufficient to deliver suppressant agent from the tank to the distribution system. The propellant may take the form of either a pyrotechnic gas generator, or a canister containing compressed gas, or yet other types of propellants known to those skilled in the art and suggested by this disclosure. According to another aspect of the present invention, the distribution system for the fire suppressant agent includes a number of conduits connected with the reservoir, with the conduits feeding a number of nozzles which may include both fixed and variable geometry nozzles. Release of the fire suppressant agent is governed by the controller, which is operatively connected with at least one accelerometer for sensing vehicle impact and at least one speed sensor for sensing vehicle speed. In addition to the automatic deployment of the fire suppression system provided by the controller, a manually activatable switch is provided for causing the reservoir to initiate delivery of the fire suppressant agent from the reservoir to the distribution system. The manually activatable switch includes a manual pushbutton mounted upon a platform which is responsive not only to manual displacement of the pushbutton, but also to manual displacement of the platform itself. According to another aspect of the present invention, a method for operating a fire suppression system installed in an automotive vehicle includes the steps of sensing an impact upon the vehicle, sensing the vehicle's speed following the impact, and discharging a fire suppression agent from an onboard reservoir in the event that the vehicle speed crosses a predetermined speed threshold following the sensing of an impact. As a variation of this method, a further step involves discharging the fire suppression agent only if the previous conditions are satisfied, as well as the additional condition that the vehicle is not experiencing acceleration in excess of a predetermined acceleration threshold. The fire suppression agent will be discharged after a predetermined period of time following a significant, or triggering, impact upon the vehicle, regardless of subsequent vehicle speed or acceleration. In this manner, the fire suppression agent will be discharged in the event that the vehicle does not move following an impact. This also permits the system to discharge the suppression agent even if the system's sensors are damaged during an impact. The sensor system used with the present fire suppression system may be combined with a control system for an occupant restraint airbag or other occupant restraints. According to another aspect of the present invention, a quick connect coupler attaches the fire suppressant feeder conduit to the suppressant reservoir. This facilitates assembly of the present fire suppression system in the underbody environment of a vehicle, thereby reducing assembly cost, while helping to assure integrity of the fire suppression system. According to another aspect of the present invention, the nozzles employed to distribute fire suppression agent discharged from the reservoir may be made from porous material, such as ceramic, or sintered metal. The nozzle may incorporate a closure bulkhead at a first end, and an integral stop abutment at a second end. As compared with a stamped or billet nozzle, a porous metal nozzle produces a more uniform distribution of suppressant agent, and at a lower cost than some competing technologies. According to another aspect of the present invention, a fire suppressant reservoir may be formed as a composite characterized by an outer wall combined with a sealing liner. This construction is generally lighter in weight than conventional all-metal pressure vessels, and offers the advantage of enhanced corrosion resistance. The sealing liner, which may be formed from plastics or metals, or yet other materials, functions to seal leaks by extruding into sealing engagement with the outer wall in the event that a pressure-formed discontinuity opens in the outer wall. The outer wall may be formed from metal or fiber reinforced resin, or other materials known to those skilled in the art and suggested by this disclosure. According to another aspect of the present invention, the gaseous propellant which expels the suppressant from the reservoir may either be the product of a pyrotechnic device, or a gas released from a charged cylinder. This cylinder may be either internal or external to the fire suppressant reservoir. If the gas cylinder is mounted externally, it offers the advantage of permitting a greater volume of fire suppressant to be carried within the reservoir. Alternatively, a smaller reservoir having the same interior volume could be employed with an external gas cylinder in the event that package space is a problem. According to yet another aspect of the present invention, the fire suppressant agent used with this system may be either a single component, such as an aqueous-based preparation, or a binary system in which the primary component is carried within a reservoir, and a secondary component, such as potassium carbonate, carried within the system's feeder conduits. In this manner, the flow of the primary component through the feeder conduits will cause the discharge of the secondary component into the flowing liquid. Then, both components will mix and be discharged simultaneously. This arrangement permits the use of a binary fire suppression agent without the need for additional storage tanks and propellant devices. According to another aspect of the present invention, in the event that a composite reservoir is specified, it will not generally be possible to weld the initiator conductor conduit, which extends from an upper portion of the system reservoir to a lower portion of the reservoir, to the reservoir itself In such case, an inventive conductor conduit having an axially compliant section and integral upper and lower bonding flanges will allow the conduit to be installed and sealed after the reservoir's pressure vessel shell has been fabricated. This axially compliant conduit permits the initiator conductor to be protected in substantially the same manner as with a welded steel reservoir, but without the need for welding. According to another aspect of the present invention, a composite reservoir for containing fire suppression agent has a lower closure with a metal or composite plug having a circumferential groove and tension ring for anchoring the outer wall of the composite wall material to the plug. This construction permits a propellant to be mounted to the lower wall of the suppressant reservoir in a manner which resists tearout of the propellant base during deployment of the present system. According to yet another aspect of the present invention, a composite reservoir has a reinforced double concave section. This configuration is necessitated by packaging considerations applicable to the vehicle underbody environment. The double concave section presents a novel design task for fiber-resin composites because the fiber reinforcement in such a section is not placed in tension by the gas force accompanying deployment of the fire suppressant agent. The reinforcements according to the present invention provide the tensile strength needed to withstand this internal gas pressure. In this manner, the volume of suppressant agent may be maximized because the double concave design feature allows the reservoir to be fitted into spaces having rather complex geometry. Such spaces are commonly found in the underbody areas of vehicles. The present fire suppression system represents an advantage over other known systems because it has the capability to suppress a fire without the wheel “shadowing” which would otherwise occur if the flow of fire suppression agent were blocked by one or more wheels when the vehicle is stopped. The present fire suppression system offers the additional advantage of not only automatic actuation, but also manual actuation, so as to allow the vehicle's operator to discharge the system even when the vehicle has not suffered a significant impact. The present system offers the additional advantage that both variable and fixed geometry nozzles are used to assure adequate dispersion of the fire suppression agent, with the integrity of the system being protected from both road splash and objects thrown up by the vehicle's wheels during normal operation of the vehicle. Because the variable geometry nozzles are normally tucked up into the vehicle underbody region well above the road surface, these nozzles are protected from damage which would otherwise result from law enforcement maneuvers such as striking curbs and driving offroad. The present system offers the additional advantage that the system operates without the need for an optical or other type of fire sensor which could become obscured, and therefore inoperable, in a vehicle underbody environment. The absence of such sensors allows the present system to begin its activation sequence immediately upon receipt of data indicating a triggering impact. The present system offers the additional advantage that the system operates in the event of impacts which are directed against a vehicle not only longitudinally, but also laterally. The present fire suppression system is designed advantageously to help reduce the risk of injury in high-speed rear impacts. The fire suppression system deploys chemicals designed to suppress the spread of fire or potentially extinguish a fire, thereby providing more time for occupants to escape from a crashed vehicle. Other advantages, as well as objects and features of the present invention will become apparent to the reader of this specification. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a ghost perspective view of an automotive vehicle having a fire suppression system according to the present invention. FIG. 2 is an exploded perspective view of a portion of a fire suppression system according to the present invention. FIG. 3 is a perspective view of a control module used with a system according to the present invention. FIG. 4 is a perspective view of a manually activatable switch used with a fire suppression system according to the present invention. FIG. 5 illustrates a portion of a wiring harness used with the present system. FIG. 6 is a flowchart showing a portion of the logic used to control a system according to the present invention. FIG. 7 is a cutaway perspective view of a fire suppression agent reservoir according to one aspect of the present invention. FIG. 8 is a perspective view of a variable geometry fire suppression agent nozzle according to one aspect of the present invention. FIG. 9 is a block diagram of a fire suppression system and with additional components for occupant restraint according to one aspect of the present invention. FIG. 10 depicts a portion of a distribution system having a porous nozzle, shown in a closed position. FIG. 11 depicts the nozzle of FIG. 10 in an open position. FIG. 12 illustrates a fire suppressant reservoir and distribution feeder conduit having a quick connect coupler for attaching the feeder conduit to the reservoir. FIG. 13 is a sectional view of the quick connect coupler shown in FIG. 12 . FIG. 14 is a perspective view of a locking collar incorporated within the coupler of FIGS. 12 and 13 . FIG. 15 a illustrates a composite fire suppression agent reservoir according to one aspect of the present invention. FIG. 15 b illustrates the reservoir of FIG. 15 a after a self-healing liner has stopped a pressure-induced fracture in the wall of the reservoir. FIG. 16 illustrates a propellant having an external gas cylinder according to one aspect of the present invention. FIG. 17 illustrates a connector for attaching the gas cylinder of FIG. 16 to a suppression agent reservoir. FIGS. 18 a , 18 b , 18 c , and 18 d illustrate various structures for introducing a secondary component of a binary fire suppression agent according to one aspect of the present invention. FIG. 19 illustrates an axially compliant initiator conductor conduit useful with a composite fire suppression agent reservoir according to one aspect of the present invention. FIGS. 20 a , 20 b , and 20 c illustrate steps for assembling a composite fire suppression agent reservoir having a closure plug made from a different material than the outer wall of the reservoir. FIG. 21 illustrates an assembled composite fire suppression agent reservoir having a closure plug made from a different material than the outer wall of the reservoir. FIG. 22 illustrates a reinforced composite fire suppression agent reservoir having double concave section. FIG. 22 a is taken along the line 22 a - 22 a of FIG. 22 and shows a concavity in a second direction and the sectional configuration of the reservoir according to an aspect of the present invention. FIG. 23 is a sectional view of a double concave section of the reservoir depicted in FIG. 22 . FIGS. 24 a and 24 b illustrate integral ribs formed externally and internally, respectively, as part of the composite reservoir of FIG. 22 . FIGS. 25 a and 25 b illustrate preformed ribs bonded externally and internally, respectively, to the outer wall of the composite reservoir of FIG. 22 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As shown in FIG. 1 , vehicle 10 has a passenger airbag restraint, 48 , and a driver's airbag restraint, 50 , mounted adjacent steering wheel 52 . A fire suppression system includes controller 66 which is mounted upon floor pan 68 of vehicle 10 , and reservoirs 18 which are mounted under floor pan 68 in the so-called kick-up area adjoining the rear axle of vehicle 10 . Those skilled in the art will appreciate in view of this disclosure that additional passenger restraint devices, such as seat belt pretensioners and side airbags, may be installed in a vehicle and controlled at least in part by, or in conjunction with, controller 66 . FIG. 1 shows not only reservoirs 18 but also a portion of right and left side fire suppression conduits 28 , as well as fixed geometry nozzles 30 and variable geometry nozzles 36 . As seen in FIG. 1 , variable geometry nozzles 36 project downwardly to allow fire suppression agent to be expelled from reservoirs 18 and placed at a low angle to the ground surface the vehicle is operating upon. This mode of operation is possible because variable geometry nozzles 36 are, as shown in FIG. 2 , telescopingly extensible. This telescoping feature, which is shown in greater detail in FIG. 8 , is produced by a sliding spray head, 40 , which is slidingly engaged with conduit 28 such that gas pressure within conduit 28 forces spray head 40 downwardly into its extended position, causing fire suppression agent 22 to be discharged through a number of holes 42 formed in spray head 40 . As shown in FIG. 2 , at least two variable geometry nozzles 36 may be employed with single reservoir 18 , along with at least two fixed nozzles 30 which are spray bars each having a number of orifices 34 . While in their normally closed state, variable geometry nozzles 36 are liquid-tight by virtue of seals 46 , which are interposed between an end of each of spray heads 40 and the corresponding ends of conduits 28 . In a preferred embodiment, seals 46 comprise elastomeric boots attached to an outer surface of conduit 28 . Seals 46 are simply sheared by the deploying spray head 40 when the present system is discharged. Fixed nozzles 30 are also rendered liquid-tight by covers 44 , which are simply blown off when the present system is discharged. The sealing of nozzles 30 and 36 is important, because this prevents the ingress of road splash, which could block the system in sub-freezing weather or cause corrosion or blockage due to mud or other foreign matter. Additional details of reservoir 18 are shown in FIG. 7 . Tank 90 contains approximately 1.5 L of fire suppression agent 22 , and a propellant 92 . Propellant 92 includes two squibs (not shown) which are activated simultaneously by controller 66 via lines 91 so as to release a large amount of gas, forcing fire suppressant agent 22 from tank 90 and into distribution system 26 , including conduit 28 and the various fixed and variable geometry nozzles. A preferred propellant, marketed by Primex Aerospace Company as model FS01-40, is a mixture including aminotetrazole, strontium nitrate, and magnesium carbonate. This is described in U.S. Pat. No. 6,702,033, which is hereby incorporated by reference into this specification. Those skilled in the art will appreciate in view of this disclosure that other types of propellants could be used in the present system, such as compressed gas canisters and other types of pyrotechnic and chemical devices capable of creating a gas pressure force in a vanishingly small amount of time. Moreover, fire suppressant agent 22 , which preferably includes a water-based solution with hydrocarbon surfactants, fluorosurfactants, and organic and inorganic salts sold under the trade name LVS Wet Chemical Agent® by Ansul Incorporated, could comprise other types of agents such as powders or other liquids, or yet other agents known to those skilled in the art and suggested by this disclosure. If two reservoirs 18 are employed with a vehicle, as is shown in FIG. 1 , all four squibs will be deployed simultaneously. FIG. 4 shows manually activatable switch 54 for use with the present system. As shown in FIG. 1 , switch 54 may be advantageously located on the headliner of vehicle 10 between the sun visors, or at any other convenient position. To use this switch 54 , hinged clear cover 56 is first opened by pressing on cover 56 . Thereafter, the fire suppression system may be triggered by manually pressing pushbutton 58 . If the vehicle occupants are not disposed to release cover 56 , the system may be triggered by merely sharply depressing cover 56 , thereby closing contacts (not shown) contained within platform 60 . Because the present system is intended for use when the vehicle has received a severe impact, controller 66 , which is shown in FIG. 3 , contains a redundant power reserve or supply, which allows operation of the fire suppression system for about nine seconds, even if controller 66 becomes isolated from the vehicle's electrical power supply. Wiring harness 80 , as shown in FIG. 5 , is armored, and has a para-aramid fiber inner sheath, 82 , of about 2 mm in thickness, which helps to shield the conductors within harness 80 from abrasion and cutting during a vehicle impact event. This para-aramid fiber is sold under the trade name KEVLAR® by the DuPont company. This armoring helps to assure that communication between controller 66 and reservoirs 18 remains in effect during an impact event. Post-impact communications are further aided by redundancy in the control system. Specifically, four independent sets of primary conductors, 79 a - d, extend from controller 66 to reservoirs 18 protected by sheath 82 . Moreover, an H-conductor, shown at 81 in FIG. 5 , extends between reservoirs 18 . Thus, if one or both of the primary conductors 79 a - b, or 79 c - d, extending to one of reservoirs 18 should become severed, H-conductor 81 will be available to carry the initiation signal from the undamaged lines to both of reservoirs 18 . As noted above, an important feature of the present invention resides in the fact that the control parameters include not only vehicle impact, as measured by an accelerometer such as that shown at 70 in FIG. 9 , but also vehicle speed, as measured by means of speed sensors 74 , also shown in FIG. 9 . Speed sensors 74 may advantageously be existing sensors used with an anti-lock braking system or vehicle stability system. Alternatively, speed sensors 74 could comprise a global positioning sensor or a radar or optically based ground-sensing system. Accelerometer 70 , as noted above, could be used with a conventional occupant restraint airbag system, thereby maximizing use of existing systems within the vehicle. Advantageously, accelerometer 70 may be an amalgam of two or more accelerometers having differing sensing ranges. Such arrangements are known to those skilled in the art and suggested by this disclosure. At least a portion of the various sensors could either be integrated in controller 66 or distributed about vehicle 10 . FIG. 6 shows a sequence which is used according to one aspect of the present invention for activating a release of fire suppressant agent. Beginning at block 100 , controller 66 performs various diagnostics on the present system, which are similar to the diagnostics currently employed with supplemental restraint systems. For example, various sensor values and system resistances will be evaluated on a continuous basis. Controller 66 periodically moves to block 102 , wherein the control algorithm will be shifted from a standby mode to an awake mode in the event that a vehicle acceleration, or, in other words, an impact, having a magnitude in excess of a relatively low threshold is sensed by accelerometer 70 . Also, at block 102 a backup timer will be started. If the algorithm is awakened at block 102 , controller 66 disables manually activatable switch 54 at block 104 for a predetermined amount of time, say 150 milliseconds. This serves to prevent switch 54 from inadvertently causing an out-of-sequence release of fire suppression agent. Note that at block 104 , a decision has not yet been made to deploy fire suppression agent 22 as a result of a significant impact. At block 106 , controller 66 uses output from accelerometer 70 to determine whether there has been an impact upon vehicle 10 having a severity is in excess of a predetermined threshold impact value. Such an impact may be termed a significant, or “trigger”, impact. If an impact is less severe than a trigger impact, the answer at block 106 is “no”, and controller 66 will move to block 105 , wherein an inquiry is made regarding the continuing nature of the impact event. If the event has ended, the routine moves to block 100 and continues with the diagnostics. If the event is proceeding, the answer at block 105 is “yes”, and the routine loops to block 106 . If a significant impact is sensed by the sensor system including accelerometer 70 and controller 66 , the answer at block 106 will be “yes.” If such is the case, controller 66 moves to block 108 wherein the status of a backup timer is checked. This timer was started at block 102 . Once the timer within controller 66 has counted up to a predetermined, calibratable time on the order of, for example, 5-6 seconds, controller 66 will cause propellant 92 to initiate delivery of fire suppressant agent 22 , provided the agent was not released earlier. Propellant 92 is activated by firing an electrical squib so as to initiate combustion of a pyrotechnic charge. Alternatively, a squib may be used to pierce, or otherwise breach, a pressure vessel. Those skilled in the art will appreciate in view of this disclosure that several additional means are available for generating the gas required to expel fire suppressant agent 22 from tank 90 . Such detail is beyond the scope of this invention. An important redundancy is supplied by having two squibs located within each of tanks 90 . All four squibs are energized simultaneously. The velocity of the vehicle 10 is measured at block 110 using speed sensors 74 , and compared with a low velocity threshold. In essence, controller 66 processes the signals from the various wheel speed sensors 74 by entering the greatest absolute value of the several wheel speeds into a register. This register contains both a weighted count of the number of samples below a threshold and a count of the number of samples above the threshold. When the register value crosses a threshold value, the answer at block 110 becomes “yes”. In general, the present inventors have determined that it is desirable to deploy fire suppression agent 22 prior to the vehicle coming to a stop. For example, fire suppression agent 22 could be dispersed when the vehicle slows below about 15 kph. At block 112 , controller 66 enters a measured vehicle acceleration value into a second register. Thereafter, once the acceleration register value decays below a predetermined low g threshold, the answer becomes “yes” at block 112 , and the routine moves to block 114 and releases fire suppressant agent 22 . In essence, a sensor fusion method combines all available sensor information to verify that the vehicle is approaching a halt. The routine ends at block 116 . Because the present fire suppression system uses all of the available fire suppression agent 22 in a single deployment, the system cannot be redeployed without replacing at least reservoirs 18 . FIG. 6 does not include the activation of occupant restraints 48 and 50 , it being understood that known control sequences, having much different timing constraints, may be employed for this purpose. In point of contrast, the low velocity threshold allows the present system to deliver the fire suppression agent while the vehicle is still moving, albeit at a very low velocity. This prevents the rear wheels of the vehicle from shadowing, or blocking dispersion of fire suppressant agent 22 . Also, in many cases, a vehicular fire may not become well-established until the vehicle comes to a halt. FIGS. 10 and 11 illustrate an additional nozzle embodiment according to another aspect of the present invention. Rather than having a stamped and welded construction, nozzle 232 is porous. The porous material may be either ceramic, or sintered metal, or other types of porous materials known to those skilled in the art and suggested by this disclosure. The material may be cast, or pressed, or extruded, or formed by any other suitable method. FIG. 10 shows nozzle body 236 in its stowed position, and FIG. 11 shows nozzle body 236 in its telescopically deployed position, which results from the buildup of fluid pressure within feeder conduit 28 . While in the stowed position of FIG. 10 , nozzle body 236 is retained within feeder conduit 28 by frangible sealing disc 252 , which functions as a stowage seal by sealing against annular surface 258 formed in the end of feeder conduit 28 . Frangible sealing disc 252 is maintained in contact with annular surface 258 by means of external seal retainer 260 , which is attached to the outer end of feeder conduit 28 . Frangible sealing disc 252 serves not only to prevent the ingress of contamination into feeder conduit 28 when nozzle body 236 is in its stowed position, but also prevents the escape of fire suppression agent from the closed, or bulkhead end, 244 of nozzle body 236 . This feature may be used to tune or adjust the distribution of fire suppression agent from nozzle 232 . When nozzle body 236 is projecting telescopically from feeder conduit 28 , integral stop abutment and fluid seal 248 cooperates with internal stop abutment 256 formed at the end of conduit 28 to both seal the joint between nozzle body 236 and feeder conduit 28 , and to prevent nozzle body 236 from separating from feeder conduit 28 in response to the fluid pressure of the flowing fire suppressant agent. FIGS. 12 , 13 , and 14 illustrate another aspect of the present invention. A quick connect coupler attaches the fire suppressant feeder conduit to the suppressant reservoir. This facilitates assembly of the present fire suppression system in the underbody environment of a vehicle, thereby reducing assembly cost, while helping to assure integrity of the fire suppression system. Reservoir 18 is equipped with a spud, 200 , having external threads, 204 . Threads 204 are interrupted. The importance of this feature will be explained below. Feeder conduit 28 has an annular retention flange, 208 , which abuts collar 216 when feeder conduit 28 is attached to reservoir 18 . A section of a fully assembled joint consisting of feeder conduit 28 , spud 200 , collar 216 , and o-ring seal 212 is shown fully assembled in FIG. 13 . Threads 220 , which are formed internally on collar 216 , cooperate with threads 204 formed on spud 200 to lock the various components together. O-ring seal is compressed between bore 202 of spud 200 and an outer surface of conduit 28 , so as to provide a leak-tight seal between spud 200 and conduit 28 . The joint of FIG. 13 is made up by inserting conduit 28 into spud bore 202 until retention flange 208 abuts spud 200 . Then, collar 216 is brought into contact with spud 200 and collar 216 is rotated to lock threads 204 and 220 . Because each of threads 204 and 220 are interrupted—i.e., they do not circumscribe the bases to which they are attached, collar 216 may be fully driven and seated upon spud 200 with less than one full revolution. This greatly facilitates assembly of the present system under a vehicle body. FIG. 14 illustrates an anti-rotation feature provided by axially displaceable pints 224 . When collar 216 has been fully rotated upon spud 200 , pins 224 will be extended by compression springs (one spring, 228 being shown). Once pins 224 have extended, rotation of collar 216 in a direction permitting detachment of collar 216 from spud 200 will be prevented because each of pins 224 will abut one of threads 204 formed on spud 200 . FIGS. 15 a and 15 b illustrate a fire suppressant reservoir, 264 , formed as a composite characterized by a pressure vessel having an outer wall, 268 , combined with a sealing liner, 272 . Outer wall 268 may be formed from metal or fiber reinforced resin, or other metallic or nonmetallic materials or composites known to those skilled in the art and suggested by this disclosure. Liner 272 is said to be a dynamic reservoir seal because liner 272 is sufficiently extrudable in response to fluid pressure produced by the propellant device that liner 272 will extrude or squeeze directly into discontinuities caused by the high operating pressure of the present fire suppression system. This extrusion will seal outer wall 268 , preventing an excessive loss of the fire suppressant agent. In FIG. 15 b , portion 280 of liner 272 is shown as having extruded through discontinuity 276 . As shown in FIG. 15 b , portion 280 is in sealing engagement with outer wall 268 . Sealing liner 272 may be formed from plastics or metals, elastomers, composites, or yet other materials known to those skilled in the art and suggested by this disclosure. In any event liner 272 is selected to provide the pressure-driven extrusion characteristic needed to seal outer wall 268 if a high pressure leak develops in reservoir 18 . FIG. 16 shows a second type of propellant useful for practicing the present invention. Compressed gas cylinder 284 is pre-charged with a high pressure gas, such as nitrogen. Valve 288 , which is operatively connected with controller 66 , is opened when needed to permit gas to flow from cylinder 284 and through high pressure conduit 292 , thereby initiating discharge of the fire suppressant agent from reservoir 18 . As but one alternative to the arrangement shown in FIG. 16 , gas cylinder 284 could be located within reservoir 18 in the manner shown in FIGS. 15 a and 15 b , albeit at the expense of volume for the fire suppressant agent. The present compressed gas propellant provides a supply-chain advantage, inasmuch as non-pyrotechnic propellants are subject to less stringent shipping restrictions than are pyrotechnic devices. FIG. 17 illustrates a system for connecting high pressure conduit 292 with reservoir 18 . A dome, 298 is provided in an upper surface of reservoir 18 . Dome 298 has a port, 296 , through which conduit 292 extends into the interior of reservoir 18 . As conduit 292 is inserted, it displaces valve disc 308 and spring 312 . Conduit 292 is retained within port 296 by means of retainer 300 , which passes through holes (not shown) formed dome 298 . Once conduit 292 has been installed, high pressure gas may flow into reservoir 18 through a series of exit orifices 304 formed in conduit 292 . According to another aspect of the present invention, a fire suppressant agent used with this system may be either a single component, generally an aqueous-based preparation, or a binary system in which a primary component is carried within a first, or primary, reservoir, and a secondary component, such as potassium carbonate, is carried within a secondary reservoir accessible to the fire suppression system's feeder conduits. Passage of the primary component through a feeder conduit will cause the secondary component to be released such that the primary component and the secondary component will be combined before being discharged from the distribution nozzles. In essence, the purpose of the secondary component delivery system is to place the secondary component into a stream of primary component flowing within the present distribution system. If the secondary delivery system is housed within feeder conduit 28 , the need for an additional discrete reservoir for the secondary component may be avoided. FIGS. 18 a - 18 d illustrate several embodiments of secondary reservoirs. FIG. 18 a shows a secondary reservoir defined by venturi tube 316 , which establishes an annular-shaped storage chamber, 320 within feeder conduit 28 . A number orifices, 324 are formed at the throat, 322 , of venturi tube 316 , such that primary component flowing through venturi tube 316 will cause secondary component 318 to be drawn through orifices 324 and aspirated into the flowing primary component stream. In the embodiment of FIG. 18 a , secondary component 318 could be in either a liquid or a powder state. FIG. 18 b illustrates a secondary reservoir having a generally cylindrical housing, 328 , which is filled with secondary component 318 in either a powder or gelatinous state. As with the embodiment of FIG. 18 a , housing 328 is located within feeder conduit 28 . Pressure-responsive piston 332 is displaced by the pressure of the flowing primary component, and, as piston 332 moves down the bore of cylindrical housing 328 , secondary component 318 will be expelled through discharge orifices 336 . FIG. 18 c illustrates a secondary reservoir having a generally cylindrical housing, 340 , enclosing a quantity of secondary component 318 , preferably in either a gelatinous or powdered state. When the primary component is flowing through feeder conduit 28 , turbine 346 , as well as shaft 352 and shredder blade 356 , will rotate in the manner of a windmill. As a result, shredder blade 356 will cooperate with shredder plate 360 to pulverize secondary component 318 , which is forced through shredder plate 360 by piston 344 and compression spring 348 . FIG. 18 d illustrates a sacrificial secondary reservoir having a hollow cylindrical plug or lining, 364 made from solid secondary component, such as potassium carbonate. Lining 364 has a number of integral internal splines, 368 . Lining 364 is formulated and processed so that flowing primary component will cause lining 364 to be eroded and entrained in the flowing primary component. With a composite fire suppressant reservoir, it is generally not possible to weld the initiator conductor conduit extending from an upper portion of the reservoir to a lower portion of the reservoir, to the reservoir itself. However, with the axially compliant conduit illustrated in FIG. 19 , this problem is avoided, while permitting the initiator conductor to be protected against damage. Conduit 384 is inserted into reservoir 18 after the pressure vessel shell, in this case, the outer wall of reservoir 18 , has been fabricated. This process begins with insertion of conduit 384 into the interior of reservoir 18 through assembly port 378 . Installation of conduit 384 continues with placement of the conduit's upper end, 384 a , into an upper conduit port formed in wall 18 a . Then, axial compliance section 388 is compressed sufficiently to allow lower end 384 b of conduit 384 to be inserted to a lower conduit port located in lower wall 18 b . Conduit 384 is then permitted to expand axially. Then, an initiator conductor or wire, 380 may be inserted into conduit 384 . Finally, propellant device 372 , which is attached to base 382 , may be mounted within port 378 . Conduit 384 has an upset section, 396 , adjacent to each of its upper and lower ends, 384 a and 384 b , and these upset sections 396 lock into bonding flanges 392 , which are adhesively sealed to reservoir walls 18 a and 18 b. FIGS. 20 a - 20 c illustrate a method for assembling a composite fire suppression agent reservoir having a closure plug either made from a different material than the outer wall of the reservoir, or from a material which is not thermally weldable to the outer wall. FIG. 20 a shows a preform having outer wall 400 , and inner reinforcement 404 . Closure plug 406 has a circumferential groove, 406 a , which allows tension band 410 purchase to bind outer wall 400 and inner reinforcement 404 to closure plug 406 . Plug 406 may be solvent welded, or bonded with various adhesives known to those skilled in the art, to outer wall 400 and inner reinforcement 404 . The embodiment of FIGS. 20 a - 20 c is especially useful for practicing a variant of the present invention in which an external propellant is employed. On the other hand, the embodiment of FIG. 21 shows a combined structure in which closure plug 412 is also employed as a base for internally located propellant 372 . As before, plug 412 may be attached to the composite wall of reservoir 18 both mechanically by means of tension band 410 and/or by chemical bonding or friction welding. FIGS. 22-25 b show a reservoir construction based upon a composite wall, 424 , which may be formed from fiber or metal reinforced resin, or other composites known to those skilled in the art and suggested by this disclosure. The reservoir shown in FIG. 22 , which is ideally constructed of composite material 424 , employs at least one double concave section to promote the adaptability of the reservoir for installation into spaces having irregular geometry. Accordingly, reservoir 416 is shown with double concave section 420 , which is generally bowl-shaped. FIG. 22 shows a first concavity, following the curve of arrow “A,” and FIG. 22 a shows a second concavity following the curve of arrow “B.” Of course, both concavities originate at the outside of reservoir 416 . Section 420 is reinforced by metallic doubler 428 , which may be insert molded to the interior surface of double concave section 420 . FIG. 24 a illustrates an embodiment in which mold 426 has a groove, 427 , which forms an integral rib, 432 , on an outer portion of double concave section 420 during the process of molding reservoir 416 . FIG. 24 b illustrates a similar embodiment in which rib 432 is formed on an inner surface of section 420 . In the interest of clarity, mold 426 is not shown in FIG. 24 b , or FIGS. 25 a and 25 b . In the embodiments of FIGS. 25 a and 25 b , preformed ribs are insert molded to double concave section 420 . More specifically, in FIG. 25 a , rib 436 is shown as having been insert molded to an outer portion of section 420 , and in FIG. 25 b , rib 436 is shown as having been molded or bonded to an inner surface of section 420 . Those skilled in the art will appreciate in view of this disclosure that insert molding may be accomplished by fabricating a preform, in this case ribs 436 , which are placed into the mold 426 prior to injecting and curing the resin. Ribs 436 may be fabricated from either fiber-reinforced resin, or other metallic or non-metallic materials or composites known to those skilled in the art and suggested by this disclosure. Although the present invention has been described in connection with particular embodiments thereof, it is to be understood that various modifications, alterations, and adaptations may be made by those skilled in the art without departing from the spirit and scope of the invention set forth in the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This is a continuation-in-part of co-pending application Ser. No. 09/558,044, filed Apr. 26, 2000. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to total hip arthroplasty, and, more particularly, to a method and apparatus for performing a minimally invasive total hip arthroplasty. [0004] 2. Description of the Related Art [0005] Orthopaedic procedures for the replacement of all, or a portion of, a patient's joint have been developed over the last 30 years. Currently, the procedures used to prepare the bone and seat the implants are generally referred to as open procedures. For the purpose of this discussion, the term open procedure will refer to a procedure wherein an incision is made through the skin and underlying tissue to fully expose a large portion of the particular joint surface. In the case of a total hip arthroplasty, the typical incision required is approximately 25 centimeters (10 inches) long. After the initial incision in the skin, the internal wound may be enlarged in order to fully expose the areas to be prepared. While this approach provides surgeons with an excellent view of the bone surface, the underlying damage to the soft tissue, including the muscles, can lengthen a patient's rehabilitation time after surgery. While the implants may be well fixed at the time of surgery, it may be several weeks or perhaps months before the soft tissues violated during surgery can be fully healed. SUMMARY OF THE INVENTION [0006] The present invention provides an improved method and apparatus for performing a minimally invasive total hip arthroplasty. A total hip arthroplasty can be performed in accordance with the teachings of the current invention utilizing two incisions with the size of each of the wounds developed on the surface being substantially constant throughout the depth of the wound. The first incision is an anterior incision approximately 3.75-5 centimeters (1.5-2 inches) in length made in line with the femoral neck and the central axis of the acetabulum. The second incision is a posterior incision approximately 2.5-3.75 centimeters (1-1.5 inches) positioned to be generally in axial alignment with the femoral shaft. [0007] The femoral head is severed from the femoral shaft and removed through the anterior incision. The acetabular cup is placed in the acetabulum through the anterior incision, while the posterior incision is used to prepare the femoral shaft to receive a femoral stem. A femoral stem is inserted through the posterior incision and positioned in the femoral shaft. Procedures performed through the posterior incision may be observed through the anterior incision and vice versa. [0008] For the purpose of the following discussion, a total hip arthroplasty is defined as a replacement of the femoral head with or without the use of a separate acetabular component. The specific designs which can be utilized in accordance with the present invention include a total hip replacement and a bipolar or monopolar endo prosthesis. The technique is suitable for cemented or cementless anchorage of the components. [0009] The invention, in one form thereof, comprises a method of performing a total hip arthroplasty. The method of this form of the current invention includes the steps of: making an anterior incision, making a posterior incision, preparing an acetabulum to receive an acetabular cup through the anterior incision, seating an acetabular cup in the acetabulum through the anterior incision, preparing a femur to receive a femoral stem, and seating the femoral stem in the femur. [0010] The invention, in another form thereof, comprises a method of performing a total hip arthroplasty. The method of this form of the current invention includes the steps of: preparing a femur to receive a femoral stem, placing a protective bag over the femoral stem, and seating the femoral stem in the femur. [0011] The invention, in another form thereof, comprises a method of performing a total hip arthroplasty. The method of this form of the current invention includes the steps of: placing the patient in supine position; palpating the femoral neck and making an anterior incision of about 3.75-5 centimeters (1.5-2 inches) in line with the femoral neck and the central axis of the acetabulum; performing a blunt dissection of the muscle exposed by the anterior incision to expose the capsule of the hip joint; incising the capsule of the hip joint; retracting a portion of the capsule to visually expose the femoral neck; utilizing an osteotomy guide to mark a cut path along which a cut will be made to remove the femoral head and a portion of the femoral neck; cutting along the cut path; incising the ligamentum teres femoris; in situ morselizing the cut away femoral head and neck as necessary for removal through the anterior incision; removing the morsels of the femoral neck and head through the anterior incision; reaming the acetabulum; seating the appropriate acetabular cup in the reamed acetabulum; inserting a curved awl having a substantially straight distal end into the anterior incision; aligning the distal end of the awl with the femoral axis; palpating the distal end of the awl and making a posterior incision having a length of about 2.5-3.75 centimeters (1-1.5 inches) at the location of the distal end of the awl; performing a blunt dissection to provide an access through the posterior incision to the femoral shaft; threading a retractor into the recess formed between the posterior incision and the femoral shaft; passing a guide wire through the retractor and into the cancellous bone of the femoral shaft; positioning the guide wire in the cannula of a femoral reamer; reaming the femoral shaft with the femoral reamer using the guide wire to locate the cancellous bone of the femur; observing the reaming activity through the anterior incision; removing the femoral reamer; utilizing the guide wire to guide a rasp to the femoral shaft; positioning the rasp in the femoral shaft while observing through the anterior incision; removing the guide wire; removing the retractor from the posterior incision; positioning a trial acetabular liner in the acetabular cup through the anterior incision; affixing a provisional neck to the rasp through the anterior incision; affixing a provisional head to the provisional neck through the anterior incision; performing a trial reduction with the trial acetabular liner, provisional neck and provisional head in place; dislocating the provisional head; removing the trial acetabular liner through the anterior incision; removing the provisional neck and head through the anterior incision; removing the rasp through the posterior incision; seating a final acetabular liner in the acetabular cup through the anterior incision; inserting a femoral implant through the posterior incision; inserting a final femoral head through the anterior incision; affixing the final femoral head to the femoral implant; reducing the hip; and closing the incisions. [0012] In one form of the current invention, the step of positioning a rasp in the femoral shaft comprises: locking the rasp to a rasp handle having a cannular insertion member with a distal rasp engagement guide and an elongate aperture sized to accommodate a flexible cable, an engagement slot for selectively engaging an end of the flexible cable, a selectively actuatable grip operable to tension the flexible cable, a lock for selectively locking the grip in a position to tension the flexible cable, and an impact surface for receiving blows to place or remove the rasp; positioning the guide wire in a cannula of the rasp and the cannula of the rasp handle; guiding the rasp and the cannular insertion member through the posterior retractor to a proximal end of the femoral shaft using the guide wire; striking the impact surface to position the rasp within the femoral shaft; unlocking the grip; releasing the flexible cable from the engagement slot; and removing the rasp handle. [0013] In one form of the current invention, the step of locking the rasp to a rasp handle comprises: engaging a distal end of the flexible cable in the rasp; inserting the flexible cable through the elongate aperture of the rasp handle; guiding the distal rasp engagement guide into a rasp engagement guide receiving portion on the rasp; engaging the proximal end of the flexible cable in the engagement slot; and tensioning the flexible cable. [0014] In one form of the current invention, the step of removing the rasp from the femoral shaft comprises: reinserting the flexible cable through the elongate aperture of the cannular insertion member (the flexible cable remains engaged with the rasp placed in the femur and protrudes from the posterior wound); reinserting the cannular insertion member through the posterior retractor; guiding the distal rasp engagement guide into the rasp engagement receiving portion on the rasp; engaging the proximal end of the flexible cable in the engagement slot; tensioning the flexible cable; and impacting the impact surface to remove the rasp from the femoral shaft. [0015] The invention, in another form thereof, comprises a method of removing a femoral neck and head. The method of this form of the current invention includes the steps of: making an anterior incision in line with the femoral neck; providing an osteotomy guide having a handle and with an alignment portion and a cut guide affixed to the handle; aligning the alignment portion with the femoral axis, marking a cut path defined by the cut guide, and cutting along the cut path to remove a cut portion comprising a portion of the femoral neck and the femoral head. [0016] The invention, in another form thereof, comprises a method of making a posterior incision aligned with a longitudinal axis of the femur. The method of this form of the current invention includes the steps of making an anterior incision aligned with the femoral neck, providing an awl having a handle and a curved awl shaft having a distal end, aligning the distal end with the longitudinal axis of the femur, palpating a location of the distal end of the awl, and making a posterior incision at the location of the distal end of the awl. [0017] The invention, in another form thereof, comprises a method of preparing a femur to receive a femoral implant. The method of this form of the current invention includes the steps of: removing the femoral head and neck as necessary, making a posterior incision of approximately 2.5-3.75 cm which is substantially aligned with the central axis of the femoral shaft, performing a blunt dissection to provide an access through the posterior incision to expose the femoral shaft, inserting a retractor comprising a tunnel sized for insertion through the access into the access, and preparing the femur to receive a femoral implant through the retractor. [0018] The invention, in another form thereof, comprises an osteotomy guide having a handle allowing use of the osteotomy guide a distance from a femur as well as an alignment portion and a cut guide affixed to the handle. [0019] The invention, in another form thereof, comprises an awl having a handle and an awl shaft with a distal end. The distal end of the awl shaft is adapted to be inserted into an anterior incision and aligned with the longitudinal axis of a femur to locate a posterior incision operable to expose a proximal end of the femur. [0020] The invention, in another form thereof, comprises a retractor formed of a tunnel sized for insertion through an access leading to the femoral shaft in a body. [0021] The invention, in another form thereof, comprises a rasp handle having an insertion member with engagement means for selectively engaging a cable which is affixable to a rasp. In one form of the current invention, the engagement means comprises an engagement slot for selectively engaging the cable. [0022] The invention, in another form thereof, comprises a provisional femoral neck apparatus including a provisional femoral neck having a hollow, substantially cylidrical body. A spring biased locking piston is provided and housed within said hollow cylindrical body. The locking piston includes a tapered body portion. Application of a radial force to the tapered body portion moves the locking piston against the biasing force of the spring. The blades of a forceps may be utilized to apply the radial force to the tapered portion of the locking piston. [0023] The invention, in another form thereof, comprises a provisional prosthetic femoral neck having a guide surface and a provisional femoral stem including a mate to the guide surface. The guide surface is piloted to the mate to join the femoral neck and the femoral stem. In one form of the current invention, the femoral neck is substantially cylindrical and is piloted to the femoral stem in a radial direction. [0024] The apparatus and method of the current invention advantageously allow a total hip arthroplasty to be performed in a minimally invasive way, which hastens patient recovery. BRIEF DESCRIPTION OF THE DRAWINGS [0025] The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, wherein: [0026] [0026]FIG. 1 is a side elevational view of a patient illustrating a pair of incisions made according to the current invention as well as the incision utilized in prior art procedures; [0027] [0027]FIG. 2 is an anterior elevational view of a hip joint illustrating the femoral neck axis; [0028] [0028]FIG. 2A is an anterior elevational view illustrating the capsule of the hip joint; [0029] [0029]FIG. 3 is an anterior elevational view of the femoral neck exposed by incising the hip capsule; [0030] [0030]FIG. 4 is an anterior elevational view of the femoral neck with an osteotomy guide of one form of the current invention operably positioned to designate a cut line thereon; [0031] [0031]FIG. 5A is a side elevational view of an alternative embodiment of an osteotomy guide in accordance with the present invention; [0032] [0032]FIG. 5B is an elevational view thereof taken along the longitudinal axis of the handle; [0033] [0033]FIG. 6 is an anterior elevational view illustrating the femoral head and neck severed along the cut line indicated by the osteotomy guide; [0034] [0034]FIG. 7 is an anterior elevational view illustrating the removal of a portion of the femoral head and neck; [0035] [0035]FIGS. 8A and 8B illustrate preparation of the acetabulum to receive the acetabular cup; [0036] [0036]FIG. 9 is a side elevational view of an acetabular cup inserter relative to a patient lying in the supine position; [0037] [0037]FIG. 10 is an anterior elevational view of a portion of the cup inserter illustrated in FIG. 9 and a patient lying in the supine position; [0038] [0038]FIG. 11 is a side elevational view illustrating the use of a curved awl to locate a posterior incision; [0039] [0039]FIG. 12 is a side elevational, partial sectional view of an awl in accordance with the present invention; [0040] [0040]FIG. 13 is a perspective view illustrating the insertion of a posterior retractor in the posterior incision; [0041] [0041]FIG. 14 is a perspective, exploded view of one embodiment of a tubular retractor in accordance with the present invention; [0042] [0042]FIG. 14A is a side elevational view of an alternative embodiment of the tubular retractor; [0043] [0043]FIG. 15 is a perspective view illustrating the insertion of a guide wire into the tubular retractor; [0044] [0044]FIG. 16 is a perspective view illustrating reaming of the femoral shaft; [0045] [0045]FIG. 17A is a perspective view of an end cutter; [0046] [0046]FIG. 17B is a perspective view of a femoral reamer; [0047] [0047]FIG. 18 is a side elevational, partial sectional view of an end cutter inserted into a tubular retractor of the present invention; [0048] [0048]FIG. 19 is a perspective view of a rasp handle after inserting a rasp into the femoral shaft; [0049] [0049]FIG. 19A is a perspective view illustrating an inserted rasp, with the rasp handle removed, and with the cable used to affix the rasp to the rasp handle protruding from the posterior incision; [0050] [0050]FIGS. 20A and 20B are partial sectional views of the rasp handle; [0051] [0051]FIG. 21 is an exploded view of the rasp handle and a rasp to be connected thereto; [0052] [0052]FIG. 21A is a partial elevational view along line 21 A- 21 A of FIG. 21; [0053] [0053]FIG. 22 is a perspective view illustrating placement of a provisional neck of the present invention; [0054] [0054]FIG. 23 is a perspective view of the provisional neck and mating forceps of the present invention; [0055] [0055]FIG. 24A is a partial sectional, radial elevational view of the provisional neck; [0056] [0056]FIGS. 24B and 24C are radial elevational views thereof; [0057] [0057]FIG. 25 is a perspective view illustrating the insertion of a femoral stem with a protective bag through the posterior incision; [0058] [0058]FIG. 26 is a perspective view illustrating alignment of the femoral stem while observing through the anterior incision; [0059] [0059]FIG. 27 illustrates an incision into the femoral stem protective bag prior to insertion of the femoral stem into the femoral shaft; [0060] [0060]FIG. 28 is a perspective view illustrating removal of the femoral stem protective bag while inserting the femoral stem, with observation through the anterior incision; [0061] [0061]FIG. 29 is a perspective view of a femoral stem insertion tool in accordance with the teachings of the present invention; and [0062] [0062]FIG. 30 is a perspective view of a hip prosthesis which can be implanted according to the method of the current invention. [0063] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplification set out herein illustrates one preferred embodiment of the invention, in one form, and such exemplification is not to be construed as limiting the scope of the invention in any manner. DETAILED DESCRIPTION OF THE INVENTION [0064] A total hip arthroplasty can be performed, according to the teachings of the current invention through two incisions, each no more than 5 centimeters (2 inches) in length. An anterior incision is made along the axis of the femoral neck, while a posterior incision is made generally in axial alignment with the femoral shaft. Referring to FIG. 1, a partial illustration of a patient 40 including torso 52 , buttock 50 , and leg 48 illustrates prior art incision 42 as well as anterior incision 44 and posterior incision 46 of the current invention. Prior art incision 42 is approximately 25 centimeters (10 inches) long, while anterior incision 44 and posterior incision 46 are each no more than 5 centimeters (2 inches) in length. [0065] According to the method of total hip arthroplasty of the current invention, patient 40 is initially placed in a supine position on an operating table. Either a standard operating table or, alternatively, a radiolucent Jackson table is used. A radiolucent Jackson table is preferred if the surgical team intends to use intraoperative image intensification. In one exemplary embodiment, a Storz viewsite endoscopic system can be used. A Storz viewsite endoscopic system provides a sterile viewing screen for endoscopic images. The sterile viewing screen of a Storz viewsite endoscopic system can be positioned within the surgical field immediately adjacent to anterior incision 44 . Other known endoscopic systems may further be utilized during the total hip arthroplasty of the present invention. Referring now to FIG. 2, with ipsilateral leg 48 in a neutral position, two prominent bony landmarks are palpated, the anterior superior iliac spine (ASIS) 59 and the greater trochanter 58 of femur 62 . Ilium 64 and pubis 66 of hip 68 are shown to better illustrate the relevant area of the body. In one exemplary embodiment, the approximate anterior incision starting point 71 is identified two fingerbreadths inferior and two fingerbreadths anterior to the tubercle of the greater trochanter 58 . The approximate finish point for the anterior incision is identified three fingerbreadths inferior and two fingerbreadths lateral to the anterior superior iliac spine (ASIS) 59 . In another exemplary embodiment, the approximate anterior incision starting point 71 is identified 3-4 centimeters inferior and 2 centimeters lateral to ASIS 59 . Having identified starting point 71 3-4 centimeters inferior and 2 centimeters lateral to ASIS 59 , the path of anterior incision 44 is extended obliquely from starting point 71 toward the prominence of greater trochanter 58 along the axis of femoral neck 60 . With the use of a spinal needle, the appropriate starting point 71 and the path of the anterior incision are identified by impaling the skin down to bone to confirm the central axis 70 of femoral neck 60 . [0066] An oblique incision of approximately 3.75-5 centimeters (1.5-2 inches) is made from the starting site 71 toward the prominence of the greater trochanter along the axis 70 of the femoral neck 60 and the central axis of acetabulum 54 . The incision is extended along the same plane through subcutaneous tissues, exposing the underlying fascia lata. The internervous plane between the tensor fascia lata muscle and the sartorius is identified by palpation and developed by curved scissors and blunt dissection. The sartorius can be made more prominent by externally rotating the leg to apply tension on the muscle. Deep to the tensor fascia lata and the sartorius is an internervous interval between the rectus femoris and the gluteus medius. This plane is developed by blunt dissection. A lateral retraction of the tensor fascia lata permits a visualization of the capsule 74 of the hip joint as illustrated in FIG. 2A. [0067] Leg 48 is externally rotated to create tension on capsule 74 . Capsule 74 is incised along the axis 70 (FIG. 2) of femoral neck 60 from the equator of femoral head 56 to the intertrochanteric ridge on the femur 62 . The capsular incision takes the form of an “H-shaped” window formed by incisions 72 . The H-shaped window is formed by adding supplementary perpendicular limbs around the equator of the femoral head 56 and the base of the femoral neck 60 to the initial incision along the axis 70 of femoral neck 60 . As a form of retraction, heavy sutures are used to provisionally attach the capsular flaps 73 to the subcutaneous tissues. As illustrated in FIG. 3, retractors 76 are placed inside capsular flaps 73 and underneath the superior and inferior borders of femoral neck 60 to expose the entire length of femoral neck 60 from the inferior aspect of femoral head 56 to the intertrochanteric ridge. Retractors 76 can be, e.g., Cobra retractors. In one exemplary embodiment, each retractor houses a light source and can also serve to anchor an endoscope. Retractors 76 thereby provide continuous visualization and illumination of the wound. In one exemplary embodiment, JAKOSCOPE retractors having integral fiberoptic light sources are utilized in accordance with present inventions. [0068] Referring now to FIG. 4, a femoral cutting tool 86 , e.g., an oscillating saw or a power burr is used to excise femoral neck 60 . A custom osteotomy guide 78 is placed through anterior incision 44 (FIG. 1) and functions to guide the femoral neck cut. Alignment portion 82 of osteotomy guide 78 is aligned with the longitudinal axis of femur 62 , while cut guide 84 is positioned on femoral neck 60 . Handle 80 of osteotomy guide 78 facilitates positioning and repositioning of osteotomy guide 78 through anterior incision 44 . After placement of osteotomy guide 78 , cut line 85 is scored as is known in the art. Osteotomy guide 78 is thereafter removed through anterior incision 44 and femoral cutting tool 86 is inserted through anterior incision 44 and utilized to cut along cut line 85 and displace portion 88 (FIG. 6) from femur 62 . [0069] Retractors 76 are repositioned around the anterior and posterior rims of the acetabulum. A custom curved cutting tool. (i.e., the “ligamentum teres cutter”) is passed behind femoral head 56 to sharply incise the ligamentum teres, thus mobilizing cut portion 88 as illustrated in FIG. 6. Cut portion 88 includes femoral head 56 as well as a portion of femoral neck 60 (FIG. 4). Cut portion 88 is thereafter removed through anterior incision 44 with a custom femoral head bone grasper 94 (FIG. 7). If there is difficulty removing cut portion 88 in one piece, it may be in situ morselized using cutting tool 87 (FIG. 6), e.g., a power burr. Morsels 92 may then be removed through anterior incision 44 . Morselizing of cut portion 88 is accomplished making cuts which substantially mirror the cuts in hip capsule 74 . In one exemplary embodiment, a corkscrew and hip skid removes the entire femoral neck, as in hip fracture. Irrigation and suction devices can be used to cool the bone and facilitate the removal of bony debris in hip capsule 74 . In one exemplary embodiment, a fiberoptic endoscope is placed into the hip joint to confirm the complete removal of bony debris. [0070] As illustrated in FIG. 8A, the fibro-fatty tissue within the cotyloid fossa of acetabulum 54 is removed with the use of, e.g., a high-speed acorn-tipped cutting tool 96 , Rongeur forceps, and a curette. Thereafter, the acetabular labrum is trimmed with a scalpel. As illustrated in FIG. 8B, acetabulum 54 is then progressively reamed with standard acetabular reamer 98 . Acetabular reamers within a predetermined size range are utilized until the optimal size of the acetabulum is reached. Sizing of the acetabulum is facilitated by the use of pre-operative templates and radiographs as is known in the art. Once again, an endoscope can be used to aid in visualization during the reaming process. Typically the acetabulum is under reamed by approximately 2 mm with respect to the diameter of the anticipated acetabular cup so as to create an interference fit. High speed acorn-shaped cutting tool 96 , and acetabular reamer 98 enter the body through anterior incision 44 . [0071] After a trial fitting, a press-fit acetabular cup of the appropriate size is firmly seated with a standard cup inserter 100 as illustrated in FIG. 9 and impacted into the acetabular recess as is known in the art. Acceptable press fit acetabular cups include the ZIMMER HGP II or TRILOGY cups. Proper positioning of the acetabular cup is achieved with a custom anteflexion and pelvic alignment guide. Patient 40 is placed in supine position on operating table 102 . Aligning rod 104 is aligned with the mid lateral axis of torso 52 while main shaft 105 is maintained approximately 30° from operating table 102 for proper seating of the acetabular cup. To augment fixation of the cup, a flexible drill can be used to guide the placement of one or more acetabular screws. In some cases, acetabular screws will not be necessary. The insertion of the acetabular liner is deferred until the proximal femur has been prepared for the insertion of a trial stem. As illustrated by the anterior elevational view of FIG. 10, patient 40 remains in the supine position on operating table 102 (FIG. 9) while cup inserter 100 is utilized to seat the acetabular cup. [0072] For preparation of the femur, the patient is repositioned with a pad placed under the ipsilateral hip. The hip is slightly flexed, adducted approximately 30°, and maximally externally rotated. Retractors 76 are repositioned around the medial and lateral aspects of femur 62 . Alternatively, a self-retaining retractor with a light source attachment and an endoscope holder can be positioned in anterior incision 44 to provide constant visualization and illumination of femur 62 . [0073] With a scalpel or curved osteotome, the soft tissues along the anterior surface of femur 62 just inferior to the intertrochanteric ridge are subperiosteally reflected to expose the bone for a width of approximately 1 cm. This sharp subperiosteal elevation continues superolaterally onto the anterior margin of the greater trochanter. Then with curved Mayo scissors a pathway is developed by blunt dissection that is directed superficially to the anterior fibers of the gluteus minimus towards buttock 50 (FIG. 11). [0074] As illustrated in FIG. 11, awl 106 is inserted through the anterior incision 44 , directed through the cleft between the gluteus medius and maximus in line with the shaft of the femur and piriformis fossae region, and advanced into the soft tissues of buttock 50 until its pointed distal end 108 can be palpated on the surface of the skin. Distal end 108 of awl 106 is generally aligned with the longitudinal axis of femur 62 . At the point where distal end 108 is palpated, posterior incision 46 of approximately 2-3 cm (0.8-1.2 inches) is made and extended through the subcutaneous tissues and fascia lata to expose the underlying gluteus maximus. A tract to femur 62 is developed along the path created by awl 106 . The gluteus maximus is split bluntly in line with its fibers with curved Mayo scissors. Finger dissection may be utilized to reach the posterior piriformis fossa region. Into this pathway, via posterior incision 46 , custom elliptical posterior retractor 122 , complete with its inner sleeves, is threaded (FIG. 13) down to the osteotomized femoral neck. In one exemplary embodiment, elliptical posterior retractor 122 includes posterior lip 128 (FIG. 14). In this embodiment, retractor 122 is threaded down to the osteotomized femoral neck until posterior lip 128 lies beneath the posterior intertrochanteric ridge. FIG. 14A illustrates an embodiment of rasp tunnel 130 without posterior lip 128 . In an alternative embodiment, each component of posterior retractor 122 (i.e., guide tube 124 , reamer tunnel 126 , and rasp tunnel 130 ) is individually inserted and removed as necessary. In an embodiment in which guide tube 124 , reamer tunnel 126 , and rasp tunnel 130 are individually inserted and removed into posterior incision 46 , each individual tunnel may be provided with a posterior lip similar to posterior lip 128 illustrated in FIG. 14. Rasping and reaming of the femur will now be described. The posterior capsule will be entered to facilitate rasping and reaming of the femur. [0075] Referring now to FIG. 15, blunt tipped guide wire 146 is inserted through guide tube 124 of posterior retractor 122 and advanced into femoral canal 148 . While FIG. 15 illustrates guide tube 124 nested in reamer tunnel 126 and rasp tunnel 130 , guide tube 124 may be directly inserted through posterior incision 46 . If the cancellous bone of femur 62 is too dense to permit insertion of blunt tipped guide wire 146 , then a conical cannulated reamer or end mill is used to prepare the femoral metaphysis. If a nested posterior retractor configuration is utilized, guide tube 124 must be removed so that the reamer can be inserted through reamer tunnel 126 of posterior retractor 122 . Similarly, if a nested configuration is not utilized, reamer tunnel 126 must be inserted into posterior incision 46 . In any event, blunt tipped guide wire 146 is inserted about halfway down femoral canal 148 . The following detailed description of the invention makes reference to a nested posterior retractor configuration. It will be understood by those skilled in the art that if the nested configuration is not utilized, each individual component of posterior retractor 122 will be inserted and removed through posterior incision 46 as necessary. [0076] [0076]FIG. 16 illustrates preparation of femoral canal 148 to receive rasp 204 (FIG. 19). Guide tube 124 is removed from posterior retractor 122 and end cutter 150 (FIG. 17A) is inserted through reamer tunnel 126 . FIG. 18 illustrates end cutter 150 positioned within reamer tunnel 126 . End cutter 150 includes elongate aperture 160 through which guide wire 146 passes and guides end cutter 150 . End cutter 150 is actuated by any of the many actuating devices known in the art. After end cutting is complete, end cutter 150 is removed through reamer tunnel 126 and reamer 151 (FIG. 17B) is inserted therethrough. Reamer 151 includes reamer guide aperture 161 through which guide wire 146 passes and guides reamer 151 as it reams femoral canal 148 . Reamers of progressive increase in their outer diameter are sequentially placed over guide wire 146 and femoral canal 148 is reamed until cortical “chatter” is felt. As is known in the art, the optimal diameter of femoral canal 148 is provisionally determined by preoperative templating. Some surgeons may choose to avoid reaming of the femoral shaft and instead utilize a broach as is known in the art. A broach may be inserted in accordance with the current invention as described hereinbelow with respect to rasp insertion. [0077] After the correct diameter of femoral canal 148 is reamed out, reamer tunnel 126 (FIG. 14) is removed from posterior retractor 122 so that rasp 204 and rasp handle 212 (FIG. 19) can be inserted over guide wire 146 to complete preparation of femur 62 . Guide wire 146 is inserted into rasp guide aperture 214 and rasp handle guide aperture 202 to guide rasp 204 to prepared femur 62 . Impact surface 164 is struck, as is known in the art, to place rasp 204 in femur 62 . While rasp 204 is being impacted, the rotational alignment can be assessed by direct visual scrutiny of femur 62 through anterior incision 44 . Furthermore, assessment of the alignment of rasp handle 212 with respect to the patella, lower leg, and foot facilitates alignment. On the normal proximal femoral metaphysis, a flattened area of anterior bone provides a highly reproducable landmark for the rotational alignment. This may not be true if the patient has experienced prior surgery or trama. [0078] Progressively larger rasps are inserted to achieve the optimal fit and fill in femur 62 . Once the final rasp is fully seated, rasp handle 212 is removed along with guide wire 146 and posterior retractor 122 , leaving distal end 208 of flexible cable 192 (FIG. 19A) attached to the proximal end of rasp 204 and proximal end 194 of flexible cable 192 protruding from posterior incision 46 . The operation of rasp handle 212 will be further explained below. [0079] After the final rasp is seated in femoral canal 148 , a trial acetabular liner is placed through anterior incision 44 and into the seated acetabular cup with the use of a liner inserter as is known in the art. Provisional neck 222 is inserted through anterior incision 44 and locked to the top end of the seated rasp, as illustrated in FIG. 22. A trial femoral head is placed on the Morse taper of provisional neck 222 through anterior incision 44 . The hip joint is reduced for an assessment of stability of the hip joint and limb length. Where necessary, a second assessment is made. Once the trial reduction is satisfactorily completed, the hip is dislocated and the provisional head and provisional neck 222 are removed. Rasp handle 212 is reinserted through posterior incision 46 over the free end of flexible cable 192 . Rasp handle 212 is advanced until it can be locked with the seated rasp so that impact surface 164 can be impacted and the entire tool (i.e., rasp 204 and rasp handle 212 ) can be removed. The trial acetabular liner is removed through anterior incision 44 . In an alternative embodiment, a trial reduction can be performed utilizing the final femoral implant and a trial femoral head. [0080] Via anterior incision 44 , the final acetabular liner 252 (FIG. 30) is seated into acetabular cup 250 (FIG. 30) with a liner inserter that permits its impaction in place, as is known in the art. Femoral implant 238 (FIG. 30) is anchored to femoral stem insertion tool 240 (FIG. 29) and placed through posterior incision 46 . Femoral implant 238 can be, e.g., a VERSYS fiber metal taper, or a VERSYS fiber metal midcoat available from Zimmer, Inc. As illustrated in FIG. 25, femoral implant 238 is placed in protective, disposable bag 242 prior to its introduction into posterior incision 46 . Protective, disposable bag 242 keeps femoral implant 238 clean as it is inserted through posterior incision 46 . Note that FIG. 25 illustrates femoral implant 238 oriented as it will be when placed in femur 62 . To insert femoral implant 238 through posterior incision 46 , femoral implant 238 must be rotated 180° from this position to prevent impingement on the body. Femoral implant 238 is then rotated 180° after being completely inserted through posterior incision 46 . [0081] [0081]FIG. 26 illustrates femoral stem 238 and bag 242 inserted through posterior incision 46 . When the tip of femoral stem 238 approaches the osteotomized femoral neck, the distal end of bag 242 is incised as illustrated in FIG. 27. Scalpel 246 is inserted into anterior incision 44 to incise bag 242 . As femoral stem 238 is driven into femoral canal 148 , bag 242 is progressively removed through posterior incision 46 as illustrated in FIG. 28. After femoral stem 238 is fully seated, femoral stem insertion tool 240 (FIG. 29) is removed through posterior incision 46 . Through anterior incision 44 , the final femoral head is positioned on the femoral neck Morse taper using a standard holding device and secured with a standard impaction tool and mallet. The hip is then reduced and assessed for stability. [0082] After appropriate antibiotic irrigation and pulsatile lavage, the hip capsule and the soft tissues are repaired with heavy sutures or staples. A suitable local anesthetic solution is injected into the closed hip joint as well as the capsular layer and the subcutaneous tissues, allowing superior postoperative pain relief. The fascial layers, subcutaneous tissues, and skin of both anterior and posterior wounds are closed in a conventional method and dressings are applied. A suction drain may be used at the discretion of the surgeon. [0083] Osteotomy guide 78 , illustrated in use in FIG. 4, includes handle 80 , alignment portion 82 , and cut guide 84 . In one exemplary embodiment, cut guide 84 and alignment portion 82 form a 60° angle. In one exemplary embodiment, alignment portion 82 includes a tapered distal end as illustrated in FIGS. 5A and 5B. Osteotomy guide 78 is inserted through anterior incision 44 and is positioned with alignment portion 82 being placed on femur 62 so that alignment portion 82 generally aligns with the longitudinal axis of femur 62 . Handle 80 protrudes through anterior incision 44 and may be utilized to position osteotomy guide 78 . After osteotomy guide 78 is properly positioned, cut guide 84 is utilized to mark cut line 85 on femoral neck 60 as illustrated in FIG. 4. Osteotomy guide 78 can be formed to function on either side of the body. FIG. 4 illustrates an osteotomy guide designed to function on the right femur, while FIG. 5B illustrates an osteotomy guide operable to function on the left femur. [0084] As discussed supra, awl 106 (FIG. 12) is designed for insertion through anterior incision 44 to locate posterior incision 46 (FIG. 11). Awl shaft 116 includes proximal end 110 designed for insertion into handle 112 . Handle 112 includes a longitudinal channel 120 into which proximal end 110 of awl shaft 116 may be inserted. Locking screw 118 is operably positioned in handle 112 and may be actuated by locking knob 114 . Locking knob 114 is utilized to place locking screw 118 in locking engagement with proximal end 110 of awl 106 . In one exemplary embodiment, proximal end 110 of awl 106 includes a flat portion to engage locking screw 118 and facilitate the locking engagement of awl shaft 116 to handle 112 . Awl shaft 116 further includes distal end 108 . Distal end 108 is generally straight and is utilized to generally align with a longitudinal axis of femur 62 (FIG. 1). As illustrated in FIG. 12, distal end 108 of awl shaft 116 includes a tapered end to facilitate insertion of awl 106 through anterior incision 44 to locate posterior incision 46 . Additionally, distal end 108 of awl 106 may be of smaller diameter than the body of awl shaft 116 as illustrated in FIG. 12. In an alternative embodiment, awl 106 is formed in one piece and is disposable. [0085] Referring now to FIG. 14, posterior retractor 122 comprises three nested parts. Guide tube 124 is nested in reamer tunnel 126 while reamer tunnel 126 is nested in rasp tunnel 130 . When posterior retractor 122 is threaded into posterior incision 46 , guide tube 124 , reamer tunnel 126 , and rasp tunnel 130 can be nested together to form a single unit. Rasp tunnel 130 includes exterior threads 132 to facilitate threading of posterior retractor 122 through posterior incision 46 . Rasp tunnel 130 includes rasp aperture 134 through which reamer tunnel 126 may be inserted and, in one alternative embodiment, posterior lip 128 for positioning posterior retractor 122 , as discussed above. Reamer tunnel 126 includes flange 136 which is operable to retain the position of reamer tunnel 126 within rasp tunnel 130 . Reamer tunnel 126 includes reamer aperture 138 through which guide tube 124 may be inserted. Guide tube 124 includes a tapered distal end 140 to facilitate its insertion into reamer aperture 138 . Guide tube 124 includes guide wire aperture 144 through which guide wire 146 (FIG. 15) may be inserted. Reamer aperture 138 is sized to allow insertion of end cutter 150 (FIG. 18), or femoral reamer 151 as discussed above. As illustrated in FIG. 18, guide tube 124 is removed from reamer tunnel 126 and end cutter 150 is inserted through reamer aperture 138 . Longitudinal reamer aperture 138 is sized to accommodate guide cylinders 156 and to thereby provide guidance and stability to end cutter 150 . After end cutting (and reaming, if desired) is complete, reamer tunnel 126 is removed from rasp tunnel 130 . Rasp aperture 134 is sized to accommodate insertion of rasp 204 as well as cannular insertion member 168 of rasp handle 212 . For surgeries which do not utilize reaming, the posterior retractor can comprise a rasp tunnel with a guide tube nested therein and not include a reamer tunnel as described above. As described above, posterior retractor 122 is not always utilized in its nested configuration. In one exemplary embodiment, guide tube 124 , reamer tunnel 126 , and rasp tunnel 130 are each inserted into and removed from posterior incision 46 as necessary. [0086] Referring now to FIG. 21, rasp handle 212 includes cannular insertion member 168 , impact surface 164 , grip 166 , elongate guide aperture 202 , elongate aperture 200 , and engagement channel 190 . Rasp 204 includes an aperture 216 sized to receive and retain retainer 210 on distal end 208 of flexible cable 192 . Retainer 210 is placed in aperture 216 and flexible cable 192 follows cable channel 217 to exit rasp 204 . Proximal end 194 of flexible cable 192 is inserted through elongate aperture 200 of cannular insertion member 168 and distal rasp engagement guide 206 is piloted to guide channel 215 of rasp 204 . After exiting the proximal end of elongate aperture 200 , proximal end 194 of flexible cable 192 may be received in engagement channel 190 . Engagement channel 190 is sized to accommodate and retain retainer 196 . After retainer 196 is operably positioned in engagement channel 190 , grip 166 may be actuated to tension flexible cable 192 . [0087] Referring now to FIG. 20B, retainer 196 is operably positioned in engagement channel 190 . Attaching means 184 , such as, e.g., rivets, belts, etc. are utilized to affix biasing elements 172 to grip 166 and internal handle surface 182 . Grip 166 is outwardly biased by handle biasing elements 172 and pivots about pivot point 198 . Grip 166 includes tensioning member 188 and ratchet 174 . Ratchet 174 is designed for engagement with tapered end 186 of pawl 176 . Pawl 176 includes pawl flange 178 . Spring 180 engages internal handle surface 82 and pawl flange 178 to bias pawl 176 toward cannular insertion member 168 . Actuation of grip 166 against the biasing force of biasing elements 172 rotates grip 166 about pivot point 198 , causes ratchet 174 to come into operative engagement with tapered end 186 of pawl 176 , and causes tensioning member 188 to contact flexible cable 192 . FIG. 20A illustrates grip 166 retained by pawl 176 in the closed position. As illustrated, tensioning member 188 contacts and tensions flexible cable 192 , thus locking rasp 204 to rasp handle 212 . Lock disengagement knob 170 can be pulled against the biasing force of spring 180 to unlock grip 166 . [0088] Referring now to FIG. 23, provisional neck 222 can be locked to rasp 204 utilizing forceps 220 . Forceps 220 include blade ends 230 , 232 . Blade ends 230 , 232 are sized for insertion into provisional head apertures 234 , 236 , respectively (FIGS. 24B and 24C). As illustrated in FIG. 24A, provisional neck 222 includes locking cylinder 224 and spring 228 . Spring 228 upwardly biases locking cylinder 224 . Upon insertion into apertures 234 , 236 , blade ends 230 , 232 can contact tapered portion 226 of locking cylinder 224 . Actuation of blade ends 230 , 232 against tapered portion 226 causes locking piston 224 to move in a direction opposite to the biasing force of spring 228 . Provisional neck 222 is clamped to forceps 220 and slid in a radial direction into provisional neck engagement area 218 (FIGS. 21 and 21A) on rasp 204 . After provisional neck 222 is fully slid onto rasp 204 , forceps 220 may be released, thereby allowing locking piston 224 to return to its locked position under the biasing force of spring 228 . Rasp 204 includes circular cut outs 217 which can be engaged by locking cylinder 224 to lock provisional neck 222 in place. [0089] Channels 225 (FIG. 24A) on provisional neck 222 accommodate protrusions 219 (FIG. 21) on rasp 204 . Provisional neck 222 is slid onto rasp 204 with protrusions 219 occupying channels 225 of provisional neck 222 . Stop 223 of provisional neck 222 abuts protrusions 219 when provisional neck 222 is completely slid onto rasp 204 . When stop 223 abuts protrusions 219 , locking cylinder 224 may be locked (i.e., forcep blades 230 , 232 released) so that locking cylinder 224 engages circular cut outs 217 , locking provisional neck 222 to rasp 204 . [0090] While the method of the current invention has been described with reference to a particular hip prosthesis, this is not meant to be limiting in any way and it will be understood that the method of the current invention could be used with many prosthetics, including, e.g., a cementless prosthesis, a hybrid prosthesis having a cemented stem and a cementless acetabular cup, a cemented prosthesis having both a cemented stem and a cemented acetabular cup, or an Endo prosthesis for replacing only the femoral head. In a procedure in which a cemented femoral stem is utilized, the bone cement will generally be inserted through the anterior incision. It should also be understood by those skilled in the art that in a smaller patient the method of the current invention could be performed entirely through the anterior incision with no need to make a posterior incision as described above. [0091] While this invention has been described as having a preferred design, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

1a

BACKGROUND OF THE INVENTION The invention relates to an apparatus for the transport and stocking (storage) of cigarettes in a plurality of containers which are arranged next to one another and form a storage unit and which can be filled in a filling station by means of a filling member, in particular via a filling orifice formed in the region of a bottom wall. The invention relates, furthermore, to details of the design and handling of the containers receiving the cigarettes. The handling of cigarettes after their manufacture and before packaging causes particular problems in the packaging of cigarettes. The cigarette-producing machines (makers) manufacture cigarettes with a high output of, for example, 16,000 cigarettes per minute. A relatively large number of cigarettes must be supplied to the packaging machine in an expedient way. At the same time, operational fluctuations in output of the cigarette-producing machine and of the following packaging machine have to be taken into account. It is therefore customary to place storage devices for cigarettes in the region between the two units. Depending on the fluctuations in output, cigarettes are conveyed into this store or dispensed from it. So-called trestles are known for the stocking and transport of cigarettes, namely containers which are open on two sides and which serve for receiving cigarette stock. The trestles are conventionally moved to the place of use on carriages and are emptied by tipping in the region of a cigarette magazine of a packaging machine. However, there is also already a known store with a plurality of vertical containers which are connected to form a storage unit and which each serve for receiving a cigarette stock. These containers are filled with cigarettes from above and are emptied via a lower extraction orifice (DE 2,900,778). SUMMARY OF THE INVENTION Proceeding from the state of the art, the object on which the invention is based is to propose an apparatus for the storage and handling of cigarettes, which, by the use of containers for receiving a cigarette stock, has a considerably larger storage capacity and which allows easier handling during the distribution of the stored cigarettes. To achieve this object, the apparatus according to the invention is characterized in that a plurality of storage units (units consisting of a plurality of containers) are received in a container magazine, the storage units being arranged one above the other and, if appropriate, next to one another within the container magazine in the region of at least one vertical conveyor, the storage units being capable of being fed to the filling station in succession and the individual containers of being filled or emptied in succession within the latter. The apparatus according to the invention accordingly proceeds from storage units which each consist of a plurality of containers arranged next to one another. A plurality of storage units of this type are received in a container magazine. The storage units can be integrated fixedly into the container magazine. However, more advantageous is a handling such that the storage units can, as required, be extracted individually and severally from the container magazine or fed to the latter. According to the invention, in the region of the container magazine, the individual containers are filled and/or emptied, preferably in the region of a stationary filling station. The containers of each storage unit are moved in succession into the filling or emptying station. For this purpose, the container magazine is equipped with cross-conveyors which allow the storage units to be transported relative to a filling or emptying member. A further subject of the invention is the design and handling of the containers, specifically individually or as part of a storage unit. According to the invention, to make it easier to fill and/or empty a container, during a filling (or emptying) phase, guide members for the cigarettes can be introduced into the container via an at least partially open side of the latter and can be moved out of the container gradually in conformity with the filling or emptying operation. These guide members are designed, in particular, in such a way that they form, within the container, a funnel-shaped movement cross section for the cigarettes which leads to a lower central extraction orifice. The guide members are arranged in a stationary manner and penetrate into the particular processed container only in the region of the filling or emptying station. A further special feature of the invention relates to measures in connection with the filling and emptying of the containers, namely for the operations for the opening and closing of a filling orifice of a container. This purpose is served, according to the invention, by closing flaps of the container which, when the filling orifice is open, form a lateral limitation of the conveying channel for the cigarettes. Further details of the invention relate to the design of a container magazine and of the individual containers and of the members associated with the filling or emptying of the containers. Exemplary embodiments of the invention are explained in more detail below by means of the drawings. In these: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a perspective bottom view of an apparatus for the conveyance and storage of cigarettes with a storage unit, namely a container magazine, FIG. 2 shows a perspective representation of a container magazine corresponding to that of the exemplary embodiment according to FIG. 1, with a transport device for storage units, FIG. 3 shows a simplified perspective representation of an individual container for a cigarette stock, FIG. 4 shows a partially sectional side view of an alternative design of a container for a cigarette stock in a container magazine, FIG. 5 shows a (lower) detail of a container for a cigarette stock on a greatly enlarged scale, partially in section, FIG. 6 shows a representation offset at 90° or a transverse view of the detail according to FIG. 5, FIG. 7 shows a partially sectional side view of an alternative for feeding cigarettes to a container magazine according to FIG. 4 and for conveying them away. DESCRIPTION OF PREFERRED EMBODIMENTS The exemplary embodiments illustrated in the drawings are concerned with the handling of cigarettes 10 or of other elongate bar-shaped articles. The purpose is the storage of a large number of cigarettes 10 and their transport in the region between a cigarette-producing machine and a packaging machine (neither is shown). FIGS. 1 and 2 show details of a storage apparatus of high capacity; This consists essentially of a container magazine 11 which is suitable for receiving a large number of containers 12. This will serve for receiving a relatively large cigarette stock 13 and for dispensing this. In the present case, a container 12 consists of a large-area front wall 14, of narrow vertical side walls 15 and 16 and of a bottom wall 17. As shown, on the top side, the container 12 can be open or alternatively also closed. A plurality of containers 12 are arranged next to one another, to form a fixed group of containers 12, namely a storage unit 18. The containers 12 are arranged in such a way that the side walls 15, 16 extend in a common plane. The front walls 14 are directed transversely and each close off the open side of an adjacent container 12. This gives rise to a unit consisting of a plurality of cells or chambers divided off from one another by partition walls. The width of the said cells or chambers corresponds approximately to the length of a cigarette 10. In the present case, the storage unit 18 of this design consists of 15 containers 12 or cells. The containers 12 are rectangular, as seen in horizontal projection. The capacity of such a container 12 is approximately 6,000 cigarettes. A plurality of storage units 18 are received in the container magazine 11. In the present case, this consists of two part magazines 19 and 20. Each of these part magazines 19, 20 is assigned a vertical conveyor for the storage units 18. The vertical conveyors consist of respective pairs of belt conveyors 21, 22 located opposite one another. These are provided on the outside with drivers or supporting legs 23. Vertical conveying strands 24, 25 of the belt conveyors 21, 22 located opposite one another are aligned in such a way that the supporting legs 23 extend in a common horizontal plane. The storage units 18 rest with edge regions on the supporting legs 23. By means of a mutually coordinated drive of the belt conveyor 21, 22 of a part magazine 19, 20, storage unit 18 resting on the supporting legs 23 can be moved upwards or downwards. The storage unit 18 can be moved from one part magazine 19 to the other part magazine 20 and in the opposite direction within the container magazine 11. Located for this purpose in the lower region of the container magazine 11 is a cross-conveyor 26. This likewise consists, here, of two conveyor bands 27, 28 with drivers 29 directed outwards. For the transverse transport within the container magazine 11, a storage unit 18 is set down on the cross-conveyor 26, namely on an upper conveying strand. The conveyor bands 27, 28 are arranged at such a distance from one another that the storage units 18 form a projection laterally. This extends respectively in the path of movement of the supporting legs 23. As a result, the storage units 18 can be lifted off directly from the cross-conveyor 26 and lifted into one part magazine 19, 20 or the other. Conversely, storage units 18 can be set down on the cross-conveyor 26 and be conveyed outwards or to the other part magazine. A transverse transport to the storage unit 18 from one part magazine to the other is also possible in the upper region of the container magazine 11. Here, the storage units 18 are received by a head conveyor 30 and are held movably by members not shown in detail. The storage unit 18 is moved along conveying rails 31, 32, in the present case by a slide 33 movable in the longitudinal direction of the conveying rails 31, 32. For universal handling of the cigarettes 10 or of the storage units 18, for example for transporting storage units 18 to another packaging machine, a transport vehicle of a special type is provided. This is a container carriage 34 which serves for receiving a plurality of, in the present exemplary embodiment three, storage units 18. For this purpose, the container carriage 34 is provided with a vertical supporting frame 35. Here, this is mounted eccentrically, namely laterally on an underframe 36 equipped with rollers. A telescopically movable supporting piece 37 is mounted so as to be movable up and down the supporting frame 35 acting in the same way as a supporting column. This supporting piece 37 is movable on the supporting frame 36 in the same way as a slide and can be moved, for example, by means of a pressure-medium cylinder (not shown) or also by means of a chain drive. Laterally projecting or overhanging support arms 38 are attached at a distance from one another to the supporting piece 37. The supporting arms 38 are made fork-shaped here, that is to say with two legs which are arranged at a distance from one another and on which the storage units 18 rest. By means of the container carriage 34 thus designed, a plurality of storage units 18 can be simultaneously extracted from or introduced into the container magazine 11. The distances between the supporting arms 38 correspond to the distances between successive supporting legs 23 of the belt conveyors 21, 22. By means of the overhanging supporting arms 38, the container carriage 34 can be moved up to the container magazine 11 in such a way that the storage units 18 resting on the supporting arms 38 can be transferred in the correct position onto pairs of supporting legs 23 located opposite one another or be lifted off from these. For setting down, the supporting arms 38 are lowered as a result of a downward movement of the supporting piece 37, so that the storage units 18 are set down on the supporting legs 23. For the extraction of storage units 18, the procedure takes place correspondingly in reverse. The filling and emptying of the storage units 18 or containers 12 takes place, here, in the region of the container magazine 11. This is equipped with the filling station 39. A filling member 40 is located in a region between the two part magazines 19, 20, specifically in the lower region of the container magazine 11. This arrangement is such that the containers 12 are filled with cigarettes 10 from below, namely via the bottom wall 17. The emptying of the containers 12 likewise takes place downwards, that is to say via the bottom wall 17. In the exemplary embodiment illustrated, for filling or emptying the containers 12, a storage unit 18 is conveyed in steps by the cross-conveyor 25 through the filling station 39 or above and beyond the filling member 40. The individual containers 12 pass successively into a position above the filling member 40 and are filled or emptied from below. The cross-conveyor 26 is intermittently driven correspondingly. The cigarettes 10 are fed to the container magazine 11 by a cigarette conveyor 41. This is designed in a known way and consists of upper and lower conveyor bands, between which a cigarette stream is conveyed continuously. The cigarette conveyor 41 leads to a distributor unit 42. Here, a branch 43 leads downwards into a region below the plane of movement of the lower storage unit 18. A transverse track 44 leads in the region of the cross-conveyor 26, namely between its strands, to the filling member 40 which, here is an upwardly directed track of the cigarette conveyor (FIGS. 5 and 6). A cigarette conveyor, namely a discharge conveyor 45, leads from the distributor unit 42 to the packaging machine or to another consumer for the cigarettes. Here, the discharge conveyor 45 runs in the axis of the cigarette conveyor 41. Furthermore, there follows, in the region of the distributor unit 42, a cigarette buffer 46. This is likewise designed as a cigarette conveyor and, for compensating purposes, can received limited quantities of cigarettes for a short time. The cigarette buffer 46 extends above the discharge conveyor 45 in the region between the part magazines 19, 20. During the filling of the containers 12, the cigarettes delivered by the cigarette conveyor 41 are deflected, in the region of the distributor unit 42, into the branch 43 leading downwards, then into the transverse track 44 and finally, via the upwardly directed filling member 40, into the correspondingly positioned container 12. However, cigarettes can also be conveyed further, bypassing the container magazine 11, to the packaging machine via the discharge conveyor 45. During the emptying of the containers 12, the cigarette stream runs correspondingly in reverse. Each container 12 is provided, in the region of the bottom wall 17, with a central filling orifice 47. The filling member 40 is connected to this for the purpose of the filling or emptying the container 12. To make the filling operation and the emptying of the containers 12 easier, lead or guide members 48, 49 can be introduced into the container 12. In the exemplary embodiment according to FIG. 3, the guide members 48, 49 are moved into the interior of the container 12 via the bottom wall 17. For this purpose, the bottom wall is provided, outside the region of the filling orifice 47, with recesses for the passage of the guide members 48, 49. In the exemplary embodiment shown, slots 50, 51 extending in the longitudinal direction of the bottom wall 17 are provided. Webs 52 forming the guide members 48, 49 pass through these slots 50, 51. In the exemplary embodiment of FIG. 3, there are provided two guide members 48, 49 which fill primarily lower corner regions of the container 12 located at the bottom and which thereby bring about a limitation of the space for the cigarettes 10, the said limitation being funnel-shaped or leading in a converging manner to the filling orifice 47. Each of the two guide members 48, 49 consist, here, of three webs 52 which pass through three associated slots 50, 51. In an upper end position, a guide member 48, 49 extending approximately from the filling orifice 47 as far as the upper edge to the side walls 15, 16 is produced in the container 12. The latter consequently has a funnel-shaped free inner space which makes the filling operation and also the emptying operation easier. The guide members 48, 49 are gradually retracted out of the container 12, specifically downwards through the bottom wall 17, with an increasing degree of filling of the container 12. Conversely, during emptying, the guide members 48, 49 are gradually introduced into the container 12. For better positioning, guide grooves 53 for the webs 52 are formed on the inside of the side walls 15, 16. In an advantageous alternative of the container 12, the guide members are introduced into the container 12 not via the bottom wall 17, but from the sides, that is to say via the side walls 15, 16. In this version, corresponding slots or other recesses are arranged in the side walls 15, 16. The horizontally displaceable guide members can be designed similarly to those of FIG. 3. In this alternative, the bottom wall 17 is made continuous, with the exception of the filling orifice 47, that is to say without slots 50, 51 or other orifices. The guide members 48, 49 are expediently arranged in a stationary manner solely in the region of the filling station 39. The actuation of the guide members 48, 49 can take place by suitable means, such as pressure-medium cylinders or mechanical gears. To make it easier to fill and empty the containers 12, these can have fixed built-in fittings as guide members which guide a cigarette stream in the direction of the filling orifice 47 or away from this. FIG. 4 shows a solution based on specially designed containers 12. These are designed with a funnel-shaped bottom wall 17, namely with two wall legs 54 and 55 leading in the direction of a (central) filling orifice 47. The wall legs 54, 55 directly limit the filling orifice 47 with their lower edges. In this version, the top side of the container 12 can be designed in a conventional way. With a space-saving nested positioning of the containers 12 having a V-shaped bottom wall 17, the top side is likewise made V-shaped correspondingly, with top sides 56, 57 converging towards one another. The container 12 can be closed in this region, but at least with grid-like covers which allow filling up to the upper edge of the V-legs. In the exemplary embodiment of FIG. 4, the side walls 15, 16 are provided with extensions 58. These are directed sideways and can be grasped by the supporting leg 23 of the vertical conveyors of the container magazine 11. Thus, even when the containers 12 have a V-shaped design, a container magazine 12 is possible in the way described. In this solution, the lower cross-conveyor 26 consists of two conveyor bands 27, 28 extending in inclined planes. Their upper conveying strand bears against the oblique wall legs 54, 55 of the bottom wall 17. As a result, storage units 18 consisting of containers 12 according to FIG. 4 can be moved and treated in the same way as in the exemplary embodiment of FIGS. 1 and 2. For the transverse transport of the upper storage units 18, in this exemplary embodiment the head conveyor 30 is represented as a piston rod of a pressure-medium cylinder which executes the transverse displacement from one part magazine to the other. In the various embodiments, the containers 12 are designed in a special way in the region of the filling orifice 47. Reference is made for this purpose to FIGS. 5 and 6. The details shown there relate to a container 12 in the version according to FIG. 4, that is to say with a funnel-shaped or V-shaped bottom wall 17 having wall legs 54, 55 which limit the filling orifice 47 laterally by means of the lower edges. The filling orifice 47 can be closed by a closing member. In the exemplary embodiment illustrated, this purpose is served by closing flaps, namely two closing flaps 58, 59 mounted on the lower edges of the wall legs 54, 55 of the bottom wall 17. In the closing position, each closing flap 58, 59 covers one half of the filling orifice 47. The closing flaps 58, 59 are mounted in rotary bearings 61, 62 of the bottom wall 17 by means of rotary bolts 60. Actuation, namely the transmission of pivoting movements, takes place via a transversely projecting extension 63, on which a suitable actuating member, for example a pressure-medium cylinder, acts. In the opening position, the closing flaps 58, 59 are directed downwards, so that a distance of 90° is covered between the closing position and opening position. In the opening position (FIGS. 5 and 6), the closing flaps 58, 59 serve as a lateral guide for a cigarette stream 64 which is transported to the filling orifice 47 by the filling member 40. The filling member 40 consists, here, of vertical endless conveyors 65, 66 located opposite one another. Each endless conveyor 65, 66 itself consists of a plurality of individual conveyors 67, 68, 69 and 70 located next to one another. Each individual conveyor 67 . . . 70 is formed from endless belts made of round material (rubber or plastic). Each individual conveyor 67 . . . 70 runs via a deflecting pulley 71. The deflecting pulleys 71 are arranged at a distance from one another on a common shaft 72. The cigarettes 10 are conveyed transversely and axially and, at the same time, bear on the mutually confronting conveying strands of the individual conveyors 67 . . . 70 on both sides of the filling member 40. The filling member 40 terminates at a distance below the container 12 or the filling orifice 47. In the interspace obtained, the cigarette stream 64 is limited laterally by the closing flaps 58, 59 pivoted into a vertical position. These extend into the region of the individual conveyors 67 . . . 70. In the exemplary embodiment illustrated, the closing flaps 58, 59 are made comb-like in the lower region (in a vertical position). Prong-like projections 73 penetrate into the region between the adjacent individual conveyors 67 . . . 70. In the present exemplary embodiment, there are three projections 73 with a corresponding number of gaps between the individual conveyors 67 . . . 70. This guarantees a step-free continuous guidance for the cigarette stream 64 over the entire height as far as the filling orifice 47. Located within the container 12 and above the filling orifice 47 is a stop member for temporarily fixing cigarettes 10 located at the bottom, during the closing of the filling orifice 47. In the exemplary embodiment shown, a pressure plate 74 is arranged in the region of the filling orifice 47. The pressure plate 74 extends approximately over the entire width of the filling orifice 47. The pressure plate 74 is pressed against the confronting end faces of the cigarettes 10. A number of cigarettes 10 corresponding to the size of the pressure plate 74 is thereby fixed by clamping against the opposite front wall 14. The cigarettes 10 consequently cannot fall out of the container 12 downwards. The closing flaps 58, 59 can then be moved into the closing position. The pressure plate 74 is subsequently relieved. For the actuation of the latter, a transverse leg 75 is arranged on the lower edge of the pressure plate 74. This transverse leg 75 emerges sideways from the container 12 and serves for actuating the pressure plate 74. Moreover, the latter is also movable up and down and is located only in the region of the filling station 39 in the particular container 12 being processed. Because the cigarettes 10 are fixed in the lower region of the container 12, a special closing operation can be put into practice. After the filling of the container 12 and the fixing of the cigarettes by the pressure plate 74, by means of an opposed drive of the endless conveyors 65, 66, the cigarette stream 64 is moved back or lowered in the filling member 40 to a level outside the range of movement of the closing flaps 58, 59. The control takes place via a light barrier generated by sensors 76. In the lowered position of the cigarette stream 64, as shown in FIG. 5, the closing flaps 58, 59 can be moved freely. An alternative for feeding cigarettes 10 for filling the containers 12 and for conveying them away for emptying these is shown in FIG. 7. Each container magazine 11 is assigned two separate conveyors, namely a first branch 77 solely for filling the containers 12, on the one hand, and a second branch 78 solely for emptying the containers 12, on the other hand. The branches 77 and 78 are respectively arranged on opposite sides of the container magazine 11. The first branch 77 leads downwards from the distributor unit 42 into the region below the planar movement of the lower storage unit 18. There follows here a first transverse track 79 which leads to the filling member 40. By means of the first branch 77, the cigarettes 10 can be conveyed solely in a downward direction. By means of the first transverse track 79, the cigarettes 10 are transported solely from the branch 77 to the filling member 40. The branch 77 and the transverse track 79 therefore serve purely for feeding the cigarettes 10 to the filling member 40 and consequently for filling the container 12. Accordingly, conveyor bands of the branch 77 and of the transverse track 79 can be driven in only one direction. The second branch 78 leads from the region below the plane of movement of the lower storage unit 18 upwards to the discharge conveyor 45. A second transverse track 80 leads from the filling member 40 to the second branch 78. By means of the second transverse track 80, the cigarettes 10 are transported solely from the filling member 40 to the second branch 78. By means of the second branch 78, the cigarettes 10 can be conveyed solely in the upward direction from the second transverse track 80 to the discharge conveyor 45. The second branch 78 and the second transverse track 80 therefore serve purely to convey the cigarettes 10 away from the filling member and consequently for emptying the container 12. Accordingly, the conveyor bands of the two branches 78 and the second transverse track 80 can also be driven in only one direction. In the present case too, the filling member 40 serves both for the filling and for the emptying of the containers 12. The endless bands 65, 66 of the filling member 40 can accordingly be driven in both directions.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a continuation of U.S. patent application Ser. No. 13/165,651, filed Jun. 21, 2011, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/357,981, filed on Jun. 23, 2010, both of which are incorporated herein by reference in their entirety. FIELD OF THE INVENTION [0002] This invention relates to the field of pharmaceutical chemistry and, more specifically, to pharmaceutical formulations as well as to intermediates used to prepare such formulations and to methods for manufacturing such formulations. BACKGROUND OF THE INVENTION [0003] Pyrimidine compounds useful for treatment of diabetes and other metabolic disorders are disclosed in U.S. Pat. No. 7,638,541 which is incorporated herein by reference in its entirety. One such compound is 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. Methods for preparing this compound are set forth in U.S. Ser. No. 61/351,803 filed on Jun. 4, 2010 which application is incorporated in its entirety by reference. This compound is an agonist of GPR119, a GPCR that is expressed in the pancreatic islets and the gastrointestinal tract. GPR agonists have been shown to stimulate glucose-dependent insulin secretion and release of incretin hormones leading to a preservation of beta cell health. [0004] Heretofore, described formulations of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine possessed less than optimal bioavailability properties. In turn, increased bioavailability of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. SUMMARY OF THE INVENTION [0005] This invention provides pharmaceutical formulations comprising a pharmaceutically inert carrier and a therapeutically effective amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. The pharmaceutical formulations disclosed herein exhibit improved solubility and pharmacokinetic profile. BRIEF DESCRIPTION OF THE DRAWINGS [0006] FIG. 1 provides a non-sink dissolution profile for compound A melt extruded compositions tested in simulated gastric fluid. [0007] FIG. 2 provides a non-sink dissolution profile for Compound A melt extruded compositions tested in simulated fed state intestinal fluid. [0008] FIG. 3 provides a non-sink dissolution profile for Compound A melt extruded compositions tested in simulated fasted state intestinal fluid. [0009] FIG. 4 provides a flow chart for a manufacture process of the 25% Compound A:CAP spray-dried dispersion (SDD). [0010] FIG. 5 illustrates the residual acetone content as a function of tray-drying time at 40° C./30% relative humidity (RH) for the 25% Compound A:CAP SDD, based on a headspace gas chromatography (GC) analysis. [0011] FIG. 6 provides the in vitro dissolution results for the 25% Compound A:CAP SDD and crystalline Compound A. [0012] FIG. 7 provides a flow chart for a manufacture process of uncoated Compound A SDD 25 mg tablets. [0013] FIG. 8 provides a flow chart for a manufacture process of uncoated Compound A SDD 100 mg tablets. [0014] FIG. 9 provides a process flow chart for film coating of uncoated Compound A SDD (spray dried dispersion) 25 and 100 mg tablets. [0015] FIG. 10 provides the concentration-time profile after administration of repeat (5) daily doses of compound A to subjects with IFG. [0016] FIG. 11 provides a comparison of the AUC of microcrystalline and SDD (spray dried dispersion) formulation of Compound A as a single dose. [0017] FIG. 12 provides a comparison of Cmax of microcrystalline and SDD (spray dried dispersion) formulation Compound A as a single dose. [0018] FIG. 13 provides a graphical representation of the percent reduction in glucose excursion during a MITT after administration of repeat (4) daily doses of Compound A to subjects with pre-diabetes. [0019] FIG. 14 provides the Percent Reduction in glucose excursion during a MITT after administration of repeat (4) daily doses of Compound A in pooled subsets of subjects with increasing degrees of glucose intolerance at baseline. DETAILED DESCRIPTION OF THE INVENTION [0020] The invention is directed to a pharmaceutical formulation comprising a pharmaceutically inert carrier and a therapeutically effective amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] wherein at least a portion of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. However, prior to describing this invention in greater detail, the following terms will first be defined. [0021] It is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. [0022] It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a pharmaceutically inert carrier” includes a plurality of such carriers. DEFINITIONS [0023] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As used herein the following terms have the following meanings. [0024] As used herein, the term “comprising” or “comprises” is intended to mean that the compositions and methods include the recited elements, but not excluding others. “Consisting essentially of” when used to define compositions and methods, shall mean excluding other elements of any essential significance to the combination for the stated purpose. Thus, a composition consisting essentially of the elements as defined herein would not exclude other materials or steps that do not materially affect the basic and novel characteristic(s) of the claimed invention. “Consisting of” shall mean excluding more than trace elements of other ingredients and substantial method steps. Embodiments defined by each of these transition terms are within the scope of this invention. [0025] The term “about” when used before a numerical designation, e.g., temperature, time, amount, and concentration, including range, indicates approximations which may vary by (+) or (−) 10%, 5% or 1%. [0026] As used herein, the term “Compound A” refers to 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0027] As used herein, the term “crystalline” refers to solid 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine, wherein the solid exhibits long-range order in three dimensions of at least about 100 repeat units in each dimension. [0028] As used herein, the term “non-crystalline” refers to solid 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine, that does not exhibit any long range order in the positions of the atoms. Thus, the term non-crystalline is intended to include not only solid which has essentially no order, but also solid which may have some small degree of order, but the order is in less than three dimensions and/or is only over short distances. Non-crystalline compound may be characterized by techniques known in the art such as powder x-ray diffraction (PXRD) crystallography, solid state NMR, or thermal techniques such as differential scanning calorimetry (DSC). [0029] As used herein, the term “solid dispersion” refers to a dispersion in which at least a portion of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine, is non-crystalline and dispersed in a water soluble, biologically compatible polymer. The solid dispersions of the invention can be prepared by methods known in the art, including, but not limited to, solid dispersions formed by mechanical, thermal and solvent processes. Exemplary mechanical processes include milling and extrusion; melt processes, such as high temperature fusion, solvent-modified fusion and melt-congeal processes; and solvent processes, such as non-solvent precipitation, spray coating and spray drying. See, for example, the following U.S. patents, the pertinent disclosures of which are incorporated herein by reference: U.S. Pat. Nos. 5,456,923 and 5,939,099, which describe forming dispersions by extrusion processes; U.S. Pat. Nos. 5,340,591 and 4,673,564, which describe forming dispersions by milling processes; and U.S. Pat. Nos. 5,707,646 and 4,894,235, which describe forming dispersions by melt congeal processes. In one embodiment, the solid dispersion is formed by spray drying, as disclosed in European Patent Application Publication No. 0 901 786 A2. In this process, the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine with or without the water soluble, biologically compatible polymer are dissolved in a suitable solvent, such as acetone, acetonitrile, methanol, ethanol, and methylethylketone, and the solvent is then rapidly removed from the solution by spray drying to form the solid dispersion. An example of a solid dispersion of this invention is the spray-dried solid dispersion comprising about 25 weight percent of Compound A substantially homogenously intermixed with a water soluble, biologically compatible polymer. [0030] As used herein, the term “pharmaceutically inert carrier” refers to carriers which are inert, in the sense that they do not chemically react with 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine in an adverse manner, are pharmaceutically acceptable, and have at least some solubility in aqueous solution at physiologically relevant pHs (e.g. pH1-8). Examples of pharmaceutically inert carriers are well known in the literature and, include by way of example only, cellulose acetate phthalate, magnesium stearate, lactose, lactose monohydrate, crospovidone, microcrystalline cellulose, colloidal silica dioxide, and the like. [0031] As used herein, the phrase “water soluble, biologically compatible polymer” refers to polymers which do not interact with 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine in an adverse manner that is detrimental to its use in vivo, are pharmaceutically acceptable, have at least some solubility in aqueous solution at physiologically relevant pHs (e.g. pH1-8) and which, when combined with Compound A to form a solid dispersion as that term is defined above, impart enhanced solubility to Compound A. The water soluble, biologically compatible polymer can be neutral or ionizable, and have an aqueous-solubility of at least 0.1 mg/mL over at least a portion of the pH range of 1 to 8. In one embodiment, the glass-transition temperature (Tg) of the polymer is great enough so that the resulting solid dispersion has a relatively high Tg (greater than 50° C. at 50% relative humidity (RH)). The polymer may have a Tg of at least 100° C. at 50% RH, at least 105° C. at 50% RH, or even at least 110° C. at 50% RH. [0032] As used herein, the term “substantially homogeneous” refers to solid dispersions as defined above wherein Compound A is dispersed in the solid dispersion such that the concentration of Compound A in any given amount of the solid dispersion is substantially uniform to that of any other given amount of the solid dispersion. [0033] As used herein, the phrase “therapeutically effective amount” means the amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine that will elicit the biological or medical response of a tissue, system, animal or human that is being sought by the attending clinician. “A therapeutically effective amount” includes the amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine that, when administered to a mammal for treating a disease, is sufficient to effect such treatment for the disease. The “therapeutically effective amount” will vary depending on the pharmaceutically inert carrier, the disease and its severity and the age, weight, etc., of the mammal to be treated. [0034] This invention is predicated in part on the discovery that the water solubility and the bioavailability of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is enhanced when at least a portion (e.g., more than 25%) of the compound is non-crystalline and preferably employed in combination with a water soluble, biologically compatible polymer. Without being limited to any theory, it is believed that the water soluble, biologically compatible polymer assists in maintaining the non-crystallinity of this compound. Accordingly, the invention is directed to a pharmaceutical formulation comprising a pharmaceutically inert carrier, and a therapeutically effective amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] wherein at least a portion of said 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline. [0035] This invention is further directed to intermediates useful in this invention wherein said intermediate is a solid dispersion comprising a water soluble, biologically compatible polymer 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine wherein at least a portion of said 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline. Formulations [0036] In one aspect provided is a pharmaceutical formulation comprising a pharmaceutically inert carrier and 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] wherein from about 25% to about 100%, by weight, of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline and is contained within a solid dispersion which further comprises a water soluble, biologically compatible polymer. [0037] In some embodiments, from about 50% to about 100%, by weight, of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline. In some embodiments, from about 75% to about 100%, by weight, of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline. In some embodiments, about 95%, by weight, of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline. [0038] In some embodiments, the invention further comprises solid dispersions of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine substantially homogenously dispersed throughout the solid dispersion wherein the solid dispersion further comprises a water soluble, biologically compatible polymer. Water soluble, biologically compatible polymers suitable for use in the pharmaceutical formulations of the present invention may be cellulosic or non-cellulosic. In certain embodiments, the polymers are neutral or ionizable in aqueous solution. Of these, ionizable and cellulosic polymers are preferred, with ionizable cellulosic polymers being more preferred. [0039] Exemplary water-soluble polymers include hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose phthalate, carboxy methyl ethyl cellulose, cellulose acetate phthalate, cellulose acetate trimellitate, and mixtures thereof. [0040] In some embodiments, said water soluble polymer is selected from the group consisting of povidone, copovidone, hypromellose acetate succinate, polyethylene glycol, hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose phthalate, carboxy methyl ethyl cellulose, cellulose acetate trimellitate and cellulose acetate phthalate. [0041] In some embodiments, said water soluble, biologically compatible polymer is selected from the group consisting of hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose phthalate, carboxy methyl ethyl cellulose, cellulose acetate trimellitate and cellulose acetate phthalate. In some embodiments, said polymer is cellulose acetate phthalate. [0042] In some embodiments, the solid dispersion comprises from about 5% to about 75%, by weight, of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0043] In some embodiments, the solid dispersion is employed to provide for pharmaceutical formulations further comprising a pharmaceutically inert carrier wherein the formulation comprises from about 10% to about 50%, by weight, of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0044] In some embodiments, the pharmaceutical formulation comprises from about 20% to about 30%, by weight, of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0045] In some embodiments, the pharmaceutical formulation comprises about 5%, by weight, of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine, or alternatively, about 10% by weight, or about 15% by weight, or about 20% by weight, or about 25% by weight, or about 30% by weight, or about 35% by weight, or about 40% by weight, or about 45% by weight, or about 50% by weight, or about 55% by weight, or about 60% by weight, or about 65% by weight, or about 70% by weight, or about 75% by weight, or about 80% by weight, or about 85% by weight, or about 90% by weight, or about 95% by weight. [0046] In some embodiments, the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine can exist within the solid dispersion in relatively pure non-crystalline domains, or, in some embodiments, is distributed substantially homogeneously throughout the solid dispersion. [0047] In some embodiments, the solid dispersions of this invention are substantially homogenous and comprising a water soluble, biologically compatible polymer and a therapeutically effective amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. In certain embodiments, the fraction of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine that is present in relatively pure non-crystalline domains or regions within the solid dispersion is relatively small, on the order of less than 20% by weight, and preferably less than 10% by weight of the total amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine in the composition. [0048] In one of its method aspects, the invention is directed to a method of producing solid dispersions comprising a therapeutically effective amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine and a water soluble, biologically compatible polymer, wherein from about 25% to about 100% by weight of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline, which method comprises the steps of: [0049] a) combining 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine and a solvent to form solution A; [0050] b) further combining the water soluble, biologically compatible polymer; [0051] c) rapidly removing the solvent from solution A. [0052] In some embodiments, the non-crystalline form of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine can be prepared by combining crystalline 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine with a solvent to form solution C and rapidly removing solution C. The non-crystalline form of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine can then be used to form the solid dispersions described herein. [0053] In another of its method aspects, the present invention is directed to a method of producing solid dispersions wherein from about 25% to about 100% by weight of the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine is non-crystalline, which method comprises the steps of: [0054] a) combining non-crystalline 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine and a solvent to form solution A; [0055] b) combining solution A and a water soluble, biologically compatible polymer to form solution B; and [0056] c) rapidly removing the solvent from solution B. [0057] In some embodiments, the 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine step a) is crystalline. However, in one embodiment, the non-crystalline form of this compound can be used. [0058] It is contemplated that any suitable water soluble, biologically compatible polymer can be used in step b). Non-limiting examples include, hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose phthalate, carboxy methyl ethyl cellulose, cellulose acetate phthalate, cellulose acetate trimellitate and cellulose acetate phthalate. In one embodiment, the water soluble, biologically compatible polymer is cellulose acetate phthalate. [0059] In some embodiments, the step of rapidly removing the solvent from solution B employs a spray-dryer. A spray dryer combines a liquid stream (e.g., solution A or B, above) with a drying gas, and separates the solute or suspension as a solid and the solvent into a vapor. The solid can be collected in a drum or cyclone. The liquid input stream is sprayed through a nozzle into a hot vapor stream and vaporized. Solids form as moisture quickly leaves the droplets. A nozzle is usually used to make the droplets as small as possible, maximising heat transfer and the rate of water vaporization. When a flammable solvent is used, oxygen is normally excluded from all parts of the spray drying apparatus. Therefore, suitable drying gases for use in the methods disclosed herein include inert gases, such as nitrogen, argon, carbon dioxide, helium, krypton, and xenon, at a flow rate of about 1200 g/min to about 2500 g/min. In some embodiments, the flow rate is about 1850 g/min. Typical droplet sizes can range from about 1 to about 500 micrometers, depending on the nozzle selected. Accordingly, in some embodiments, the smallest diameter of the solid dispersion is from about 1 to about 500 micrometers, or from about 1 to about 400 micrometers, or from about 5 to about 300 micrometers, or from about 5 to about 200 micrometers, or from about or 5 to about 100 micrometers, or from about or 5 to about 80 micrometers, or from about or 5 to about 60 micrometers, or from about or 5 to about 40 micrometers, or from about or 5 to about 50 micrometers, or from about or 10 to about 40 micrometers, or from about or 15 to about 35 micrometers, or about 25 micrometers. [0060] In some embodiments, solution B is delivered to the spray-dryer at a rate of from about 175 grams/min to about 250 g/min. In some embodiments, solution B is delivered to the spray-dryer at a rate of from about 200 grams/min to about 230 g/min. In some embodiments, solution B is delivered to the spray-dryer at a pressure of from about 150 psi to about 500 psi. In some embodiments, solution B is delivered to the spray-dryer at a pressure of from about 200 psi to about 450 psi. In some embodiments, solution B is delivered to the spray-dryer at a pressure of from about 300 psi to about 315 psi. For commercial scale manufacturing, the drying gas flow rate can be significantly higher. The above provides for rapid removal of the solvent such that at least a portion of Compound A remains non-crystalline. [0061] Suitable solvents for use in the spray-dryer include polar organic solvents, such as alcohols such as methanol, ethanol, n-propanol, isopropanol, and butanol; ketones such as acetone, methyl ethyl ketone and methyl isobutyl ketone; esters such as ethyl acetate and propyl acetate; and various other solvents, such as tetrahydrofuran, acetonitrile, methylene chloride, toluene, and 1,1,1-trichloroethane. In some embodiments, the solvent of solution A is acetone. [0062] The temperature of the spray-dryer can be adjusted based on the solvent employed and the size of the nozzle. In some embodiments, the spray drying is performed at a temperature of between about 100° C. and about 150° C. In some embodiments, the spray drying is performed at a temperature of between about 115° C. and about 135° C. In some embodiments, the spray drying is performed at a temperature of about 125° C. [0063] In some embodiments, the solid dispersions of this invention can be prepared by hot melting the water-soluble, biologically compatible polymer, adding the desired amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine to the hot melt under conditions to provide a uniform dispersion of the hot melt and then extruding the hot melt to form a solid dispersionsolid dispersion. The solid dispersion produced herein is sometimes referred to as a “hot melt extrudate”. Suitable polymers for hot melt purposes include, for example, povidone, copovidone, hypromellose acetate succinate, and polyethylene glycol. Compounds of the Invention [0064] The pharmaceutical formulations of the present invention comprise a therapeutically effective amount of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine, collectively referred to herein a “compound A”. Methods for the preparation of the compound A are disclosed in U.S. Ser. No. 61/351,803 filed on Jun. 4, 2010 which application is incorporated in its entirety by reference. Exemplary methods for the preparation of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine for use in the pharmaceutical formulations disclosed herein are detailed herein below. [0065] In one embodiment, provided is a method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] the method comprising: [0066] (a) contacting a compound of Formula (I) with di-tert-butyl dicarbonate (Boc 2 O) to form a compound of Formula (II) [0000] [0067] (b) contacting the compound of Formula (II) with a compound of Formula (III) to form a compound of Formula (IV) [0000] [0068] (c) contacting the compound of Formula (IV) with a compound of Formula (V) to form a compound of Formula (VI) [0000] [0069] (d) contacting the compound of Formula (VI) with a compound of Formula (VII) to form a compound of Formula (VIII) [0000] [0070] (e) contacting the compound of Formula (VIII) with acid to form a compound of Formula (IX) [0000] [0071] (f) contacting in dimethylformamide in presence of base the compound of Formula (IX) with a compound of Formula (X) wherein L is a leaving group such as F, Cl, Br, I, OS(O) 2 CF 3 , OS(O) 2 CH 3 and OS(O)CF 3 [0000] [0072] to form 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0073] In one embodiment, provided is method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] comprising contacting a compound of Formula (XXIV) with a compound of Formula (VII) in presence of base, such as NaOH, Na 2 CO 3 , K 2 CO 3 , Cs 2 CO 3 and NaH [0000] [0074] In one embodiment, provided is a method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] the method comprising: [0075] (a) contacting a compound of Formula (I) with a compound of Formula (XXI) wherein T is a leaving group such as F, Cl, Br, I, OS(O) 2 CF 3 , OS(O) 2 CH 3 and OS(O)CF 3 to form a compound of Formula (XXII) [0000] [0076] (b) contacting the compound of Formula (XXII) with a compound of Formula (III) to form a compound of Formula (XXIII) [0000] [0077] (c) contacting the compound of Formula (XXIII) with a compound of Formula (V) to form a compound of Formula (XXIV) [0000] [0078] (d) contacting the compound of Formula (XXIV) with a compound of Formula (VII) [0000] [0079] to form 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0080] In one embodiment, provided is a method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] the method comprising: [0081] (a) contacting a compound of Formula (IV) with acid to form a compound of Formula (XI) [0000] [0082] (b) contacting a compound of Formula (XXI) wherein T is a leaving group such as F, Cl, Br, I, OS(O) 2 CF 3 , OS(O) 2 CH 3 and OS(O)CF 3 , to form a compound of Formula (XXIII) [0000] [0083] (c) contacting the compound of Formula (XXIII) with a compound of Formula (V) to form a compound of Formula (XXIV) [0000] [0084] (d) contacting the compound of Formula (XXIV) with a compound of Formula (VII) [0000] [0085] to form 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0086] In some aspects, the compound of Formula (IX) and (X) are contacted at a temperature of 60° C. to 100° C. In other aspects, the temperature is 70° C. to 90° C., 79° C. to 81° C., or 80° C. [0087] In some aspects, the base is NaOH, Na 2 CO 3 , NaHCO 3 , KHCO 3 , K 2 CO 3 , Cs 2 CO 3 , Et 3 N (triethylamine) and i-Pr 2 Net (diisopropylethylamine). [0088] In some embodiments, the compound of Formula (IX) is prepared by contacting a compound of Formula (VIII) with acid [0000] [0089] In some embodiments, the compound of Formula (VIII) is prepared by contacting a compound of Formula (VI) with a compound of Formula (VII) [0000] [0090] In some aspects, the compound of the compounds of Formula (VI) and Formula (VII) are contacted in a polar organic solvent selected from dimethyl formamide (DMF) and acetonitrile (MeCN) and in presence of base. In some aspects, the base is selected from the group consisting of NaOH, Na 2 CO 3 , K 2 CO 3 , Cs 2 CO 3 and NaH. [0091] In some aspects, the compound of the solvent is MeCN. In other aspects, the solvent is DMF. [0092] In some aspects, the base is Cs 2 CO 3 . In still other aspects the base is K 2 CO 3 . [0093] In some embodiments, the compound of Formula (VI) is prepared by contacting a compound of Formula (IV) with a compound of Formula (V) [0000] [0094] In some aspects, the compounds of Formula (IV) and Formula (V) are refluxed in a polar organic solvent in presence of base. In some such aspects, the base is selected from the group consisting of Na 2 CO 3 , K 2 CO 3 , Cs 2 CO and MgCO 3 . [0095] In some embodiments, the compound of Formula (VII) is prepared by contacting 4-aminophenol with sodium azide and trimethylorthoformate. [0096] In some embodiments, the compound of Formula (IV) is prepared by contacting a compound of Formula (II) with a compound of Formula (III) [0000] [0097] In some embodiments, the compound of Formula (II) is prepared by contacting a compound of Formula (I) with di-tert-butyl dicarbonate (Boc 2 O). [0098] In one embodiment provided is a method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] the method comprising: [0099] (a) contacting the compound of Formula (XXIII) with a compound of Formula (XXIV) to form a compound of Formula (XXV) [0000] [0100] (b) contacting the compound of Formula (XXV) with a reducing agent, for example lithium aluminum hydride (LiAlH 4 ), lithium borohydride (LiBH 4 ), or diisobutyl aluminum hydride (DiBal) to form a compound of Formula (XXVI) [0000] [0101] (c) contacting the compound of Formula (XXVI) with a compound of Formula (VII) [0000] [0102] under Mitsunobu coupling conditions to form 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0103] In one embodiment provided is a method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0000] the method comprising: [0104] (a) contacting the compound of Formula (XXIII) with a compound of Formula (XXIV) to form a compound of Formula (XXV) [0000] [0105] (b) contacting the compound of Formula (XXV) with a reducing agent to form a compound of Formula (XXVI) [0000] [0106] (c) converting the compound of Formula (XXVI) to a compound of Formula (XXVII) wherein Q is a leaving group such as Cl, Br, I, OS(O) 2 CF 3 , OS(O) 2 CH 3 and OS(O)CF 3 [0000] [0107] (d) contacting the compound of Formula (XXVII) with a compound of Formula (VII) [0000] [0108] to form 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine. [0109] In one embodiment provided is a method for preparing 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine [0000] [0110] comprising contacting a compound of Formula (XXVII) wherein Q is a leaving group such as Cl, Br, I, OS(O) 2 CF 3 , OS(O) 2 CH 3 and OS(O)CF 3 with a compound of Formula (VII) in presence of base, for example NaOH, Na 2 CO 3 , K 2 CO 3 , Cs 2 CO 3 and NaH. [0000] [0111] In some aspects provided is an intermediate compound for use in the preparation of 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine selected from the group consisting of [0000] [0000] wherein Q is a leaving group such as Cl, Br, I, OS(O) 2 CF 3 , OS(O) 2 CH 3 and OS(O)CF 3 . [0112] In other embodiments, provided is 5-ethyl-2-{4-[4-(4-tetrazol-1-yl-phenoxymethyl)-thiazol-2-yl]-piperidin-1-yl}-pyrimidine having carbon 14 isotope labeling about the carbon atoms in the phenyl ring. The labeled compound can be prepared according to the following scheme from commercially available 14C(U)]-4-aminophenol hydrochloride (Archemi 1-800-331-6661, ARC-545): [0000] Compositions and Methods of Treatment [0113] In accordance with the present invention methods of treating a disease or condition selected from the group consisting of Type I diabetes, Type II diabetes and metabolic syndrome are provided. The method comprises administering to a subject in need of such treatment an effective amount of a pharmaceutical formulation of the present invention. [0114] In another aspect, methods of raising intracellular levels of Ca 2+ in a cell expressing GPR119 are provided. The method comprises exposing a cell that expresses GPR119 to a pharmaceutical formulation of the invention. Ca 2+ levels can be determined by methods known in the art. [0115] In one embodiment, the cell that expresses GPR119 is a pancreatic cell, an islet cell, or a beta cell, an intestinal endocrine cell, an L cell or a K cell. [0116] Another aspect of the invention provides a method of stimulating insulin production in a mammal, in particular a human. The method comprises administering an effective amount of a pharmaceutical formulation of the invention to the mammal. In response to administration of a compound to the subject, insulin is produced by the beta cells. Methods by which a skilled artisan can measure insulin secretion in laboratory animals in response to administration of a pharmaceutical formulation of the invention are known in the art. [0117] In another aspect, the invention provides a method of stimulating insulin secretion in a mammal, in particular a human. The method comprises administering an effective amount of a pharmaceutical formulation of the invention to the mammal. In response to administration of a pharmaceutical formulation to the subject, insulin is secreted into the blood stream by the beta cells. [0118] A further aspect of the invention provides a method of stimulating glucose-dependent insulin secretion in a mammal, in particular a human. The method comprises administering an effective amount of a pharmaceutical formulation of the invention to the mammal. After administration to the subject, insulin is secreted into the blood stream by the beta cells in a glucose-dependent manner. Methods that show the blood glucose lowering effects of the pharmaceutical formulations of the invention are known in the art. [0119] In another embodiment, the invention provides methods of lowering blood glucose in a mammal, preferably a human. The method comprises administering an effective amount of a pharmaceutical formulation of the invention to the mammal. In response to administration of a pharmaceutical formulation to the subject, blood glucose levels are lowered. In one embodiment, the blood glucose in a mammal is reduced by about 5% or more, or about 15% or more, or about 25% or more, or about 35% or more, or about 45% or more, or about 50% or more, or about 60% or more, or about 70% or more, or about 75% or more, or about 80% or more, or about 85% or more, or about 90% or more. [0120] In some embodiments, the method further comprises steps to measure blood glucose levels before and after administration of a pharmaceutical formulation of the invention. Blood glucose levels are easily measured by numerous commercially available glucose monitoring devices that measure blood glucose from samples of blood or urine. Blood glucose can also be measured by commercially available glucometers that do not require blood or urine samples. Methods that teach how to measure improvements in diabetes parameters, including blood glucose monitoring are known in the art. [0121] Another aspect of the invention provides a method of stimulating incretin production in a mammal, in particular a human. The method comprises administering an effective amount of a pharmaceutical formulation of the invention to the mammal. In response to administration of a pharmaceutical formulation to the subject, glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide is produced by the intestinal endocrine cells. Methods by which a skilled artisan can measure incretin production in laboratory animals in response to administration of a pharmaceutical formulation of the invention are known in the art. [0122] The present invention will be described in further detail by the following examples. It is to be understood, however, that these examples are given for illustrative purpose only and are not construed to limit the scope of the present invention. EXAMPLES [0123] The present invention will be described in further detail by the following examples. It is to be understood, however, that these examples are given for illustrative purpose only and are not construed to limit the scope of the present invention. Example 1 4-Carbamoyl-piperidine-1-carboxylic acid tert-butyl ester [0124] [0125] To a suspension of iosnipecotamide (255 g, 1.99 mol) and 4-dimethylamino-pyridine (204 mg, 1.82 mol) in methylene chloride (1500 mL) in a 5-lite of three-neck flask was added a solution of di-tert-butyl dicarbonate (502 g, 2.30 mol, 1.15 eq.) in methylene chloride (500 mL) dropwise at room temperature with mechanic stirring. A clear solution was reached at the end of the adding. After stirring at room temperature for two more hours, the solution was washed with phosphoric acid water solution (2.5 v/v %, 500 mL), water (500 mL), half saturated sodium bicarbonate water solution (500 mL), and 10% of brine (500 mL). The organic phase was dried over anhydrous sodium sulfate. During the course of removing of the methylene chloride, ethyl acetate (100 ml) and heptane (200 mL) was added. After removing the methylene chloride, the white solid formed was filtrated, washed with hexane, and dried to give 414 g (95%) of product. [0126] TLC: dichloromethane-methanol 90:10, Rf (product)=0.28; Rf (starting material)=base line, iodine positive. Example 2 4-Thiocarbamoyl-piperidine-1-carboxylic acid tert-butyl ester [0127] [0128] To a suspension of 4-Carbamoyl-piperidine-1-carboxylic acid tert-butyl ester (288 g, 1.26 mol) in dimethoxyethane (2000 mL) and methylene chloride (800 mL) in a 5-lite of three-neck flask was added Lawesson's Reagent (255 g, 0.63 mol). The mixture was stirred at room temperature for 80 min. TLC check there was no starting material left. The solvents were removed under vacuum. The residue was dissolved in ethyl acetate (1500 mL), and washed with half saturated potassium carbonate water solution (500 mL each, two times), 50% of brine (500 mL). The organic phase was dried over anhydrous sodium sulfate and concentrated to dry. The obtained solid was dissolved in ethyl acetate (1000 mL) and filtered at hot to remove insoluble white stuff. To the solution was added heptane (300 mL). After removing most of ethyl acetate, the solid formed was filtrated, washed with hexane-ether (1:1), and dried to give 252 g (82%) of product. [0129] TLC: dichloromethane-methanol 90:10, Rf (product)=0.37, UV and iodine positive; Rf (starting material)=0.28, iodine positive. Example 3a 4-Tetrazo-1-ly-phenol [0130] [0131] To a 2-liter one-neck flask under air, immersed in an oil bath and fitted with a refluxing condenser, was added 4-aminophenol (50 g, 0.459 mol), acetic acid (500 mL), sodium azide (41.7 g, 0.642 mol), and trimethyl orthoformate (70 mL, 68 g, 0.642 mol). The mixture was stirred at 60° C. (oil bath) for one hour and then refluxed (oil bath, 100° C.) for 3 hours. A clear solution was formed during the refluxing. The temperature of solution was lowered to 80° C. (oil bath) and water (300 mL) was added slowly. The temperature of the solution was cooled down to room temperature. The solid formed over night was filtered and dried to give 61.7 g (83%) of product as first crop. [0132] TLC: hexane-ethyl acetate 50:50, Rf (product)=0.28; Rf (starting material)=0.23, UV and iodine positive. [0133] 1 HNMR (400 MHz, D 3 COD), δ 9.58 (s, 1H), 7.61 (d, J=9.0 Hz, 2H), 6.97 (d, J=9.0 Hz, 2H) ppm. [0134] Modified procedure: The reactions were carried out at 1.5 times of the abovementioned scale. A 2-liter flask under air was charged with acidic acid followed by 4-aminophenol, sodium azide, and trimethyl orthoformate with stirring at room temperature. The flask was fitted with a bump trap and was heated to 100° C. (oil bath) during the course of 1 to 1.5 hours. Solid started to precipitate and the temperature of mixture was lowered to 80° C. Water was added and the mixture was cooled down to room temperature. The mixture was filtered and the solid was washed with water and dried to give the desired product (>88% yield). [0135] 1 HNM (400 MHz, D 3 COD), δ 9.58 (s, 1H), 7.61 (d, J=9.0 Hz, 2H), 6.97 (d, J=9.0 Hz, 2H) ppm. Example 3b [0136] [0137] To a 500 mL flask under air, immersed in an oil bath and a condenser, was added 4-thiocarbamoyl-piperidine-1-carboxylic acid tert-butyl ester (29 g, 120 mmol), acetone (300 mL) MgSO 4 (21.6 g, 180 mmol) and MgCO 3 (10 g, 120 mmol), 1,3-dichloroacetone (19.8 g, 156 mmol). The resulting mixture was heated under reflux overnight, cooled and filtered through celite. The solvent was removed in vacuo and the residue was redissolved with EtOAc (500 mL). The resulting solution was washed successively with 5% NaHSO 3 (twice), saturated NaHCO 3 and brine. After drying (NaSO 4 ), the solvent was removed to afford 35 g of the title compound as light yellow oil. The oil became dark solid after standing at room temperature. The color could be removed by activated charcoal. The purity was improved from 92% to 96%. 1 H NMR (CDCl 3 ): δ 7.20 (1H, s), 4.67 (2H, s), 4.20 (2H, br), 3.16 (1H, m), 2.87 (2H, m), 2.09 (2H, m), 1.72 (2H, m), 1.47 (9H, s). Example 4 [0138] [0139] A mixture of 4-(4-chloromethyl-thiazol-2-yl)-piperidine-1-carboxylic acid tert-butyl ester (35 g, 0.11 mol), 4-tetrazol-1-yl-phenol (21.4 g, 0.132 mol), Cs 2 CO 3 (43 g, 0.132 mol), KI (1.8 g, 11 mmol) in acetonitrile (400 mL) was heated under reflux overnight. After cooling, the solid was filtered through a pad of celite. The filtrate was concentrated in vacuo. The residue was dissolved in methylene chloride and washed with 5% aqueous NaOH (3 times), water and brine. After drying (NaSO 4 ), the solvent was removed. The resulting solid was dissolved in ethyl acetate. The resulting solution was heated with activated charcoal and filtrated through a pad of celite. The filtrate was concentrated and the residue was purified by recrystallization from EtOAc/Hexane to afford 37 g desired product. [0140] 1 H NMR (CDCl 3 ): δ 8.01 (1H, s), 7.61 (2H, d, J=8.8 Hz), 7.25 (1H, s), 7.15 (2H, d, J=8.8 Hz), 5.22 (2H, s), 4.2 (2H, br), 3.17 (1H, m), 2.87 (2H, m), 2.11 (2H, m), 1.73 (2H, m), 1.46 (9H, s). Example 5 [0141] [0142] To a 3-L 3-neck flask under N 2 fitted with an addition funnel, was added 400 mL of anhydrous methylene chloride (J.T.Baker low water grade; the CH 2 Cl 2 will facilitate the solubility of substrate) and 115.59 g of t-butyl carbamate substrate (0.26 mol) in one-portion. After stirring at rt for 2˜5 minutes, to the resulting almost clear solution was added 400 mL of methanol (J.T.Baker HPLC grade). The resulting clear brown solution was cooled to 0-4° C. (ice-water bath temperature) with stirring, and then 330 mL of 4N HCl in 1,4-dioxane (1.32 mol, 5 eq.) was added dropwise over 30 minutes. The ice-water bath was removed, and the resulting brown homogeneous solution was stirred at rt overnight (15 hours). At least 7 hours is needed to bring the reaction to completion. The reaction mixture was aliquoted and quenched into 2N NaOH, and then extracted w/ EtOAc. 1 H NMR in DMSO-d 6 . Diagnostic peaks: free-amine product δ 7.63 (s, 1H); starting material (substrate) δ 7.66 (s, 1H). Typically, the conversion was estimated via the integral of the italicized signals: 4 hrs, 80% conversion; 6 hrs, 95% conversion. The reaction solution was allowed to cool to 10° C. (ice-water bath temp), and then a solution of 15% (w/v) NaOH (705 mL; 2.64 mol, 2 eq. of HCl used) in ˜500 mL of water was added dropwise over 15 minutes. (Diluted 15% aq. NaOH was used to ensure no precipitation (inorganic salt) in the organic phase). Immediate phase break was observed when the stirring was stopped to give a brown aqueous layer on top and a pale yellow organic layer on the bottom. The organic layer was collected, and the remaining aqueous layer was extracted with CH 2 Cl 2 (500 mL×2). The organic layers were combined, rinsed with ˜500 mL of water, and dried over anhy. Na 2 SO 4 . After most of solvents were removed in vacuo, precipitation began. To this pale yellow mixture was added 500 mL of heptane to give a pale yellow slurry. The resulting precipitate was collected on a filter funnel, and the mother liquor was stripped down. The combined solids were rinsed with heptane (200 mL). After air-drying overnight, 84.1 g (94% yield) of free amine was obtained as a white or an off-white solid. [0143] 1 H NMR (DMSO-d 6 ): δ 9.98 (1H, s), 7.80 (2H, d, J=8.0 Hz), 7.63 (1H, s), 7.28 (2H, d, J=8.0 Hz), 5.20 (2H, s), 3.05 (1H, m), 2.97 (2H, m), 2.56 (2H, m), 1.93 (2H, m), 1.55 (2H, m) ppm. [0144] Instead of using HCl, if the reaction was treated with 5 eq. TFA in CH 2 Cl 2 at rt, ˜50% of an unknown by-product will be generated which can be seen by taking a 1 H NMR in DMSO-d 6 : Diagnostic peaks δ 7.45 (1H, s), 6.61 (2H, d, J=8.8 Hz), 6.44 (2H, d, J=8.8 Hz), 4.89 (2H, s) ppm. The use of CH 2 Cl 2 /CH 3 OH as co-solvents will eliminate the formation of impurities seen with other solvents. The use of 1,4-dioxane, 1,4-dioxane/methanol, or methylene chloride will produce a tiny amount of detectable impurity which can be seen by 1 H NMR in DMSO-d 6 : Diagnostic peaks δ 6.82 (m), 6.56 (m), 4.99 (m) ppm. This impurity will be carried over to the final product in the next step, and cannot be removed by purification via recrystallization. Example 6 [0145] [0146] To a 3-L 3-neck flask under N 2 was added 105.7 g of crude free amine (0.31 mol), 88.0 g of 2-chloro-5-ethylpyrimidine (0.62 mol, 2 eq.) in one-portion, and then 800 mL of anhydrous DMF. After stirring at rt for 1˜2 minutes, to the resulting clear solution was added 64.0 g of anhy. K 2 CO 3 (0.46 mol, 1.5 eq.) in one-portion. The flask was immersed in a pre-heated oil bath (90° C., oil-bath temperature), and the reaction mixture was stirred at 90° C. (oil-bath temperature) for 3.5 hours. The reaction mixture was aliquoted and quenched into water/brine, and then extracted w/ EtOAc. 1 H NMR in DMSO-d 6 . Diagnostic peaks: product δ 7.66 (s, 1H); free-amine (starting material) δ 7.63 (s, 1H); pyrimidine δ 8.67 (s, 2H), DMF δ 7.03 (s, 1H). Typically, the conversion was estimated via the integral of the italicized signals. Complete conversion was observed between 3 to 4 hours. Prolonged heating (>5 hours) resulted in the formation of the unidentified impurity. [0147] The reaction mixture was transferred to a 5-L 3-neck flask, and allowed to cool with stirring to rt with ice-water bath. To the reaction mixture at rt under stirring vigorously (mechanical stirrer) and approximate 2000 mL of water was added slowly dropwise over 30 minutes to give an off-white slurry (precipitation began when ˜500 mL of water was added). After the addition was finished, the resulting slurry was stirred at rt for an additional 10˜15 minutes. The off-white precipitate was filtered and then rinsed with water (250 mL×2). After air-drying overnight, approximate 387 g of wet off-white solid was obtained, and redissolved in 1500 mL of EtOAc by heating at 55° C. (internal solution temperature) for ca. 10 minutes. The resulting pale-yellow solution was washed with water (250 mL×3) and water/brine (200 mL/100 mL), and dried over anhy. Na 2 SO 4 . After most of solvents were removed in vacuo, precipitation began and then gave an off-white slurry (˜500 mL of solvents left). The resulting white precipitate was collected on a filter funnel, and rinsed with EtOAc (300 mL×2). The mother liquor was kept to do another recrystallization later on, and the precipitate on the filter funnel was rinsed once more time with 300 mL of heptane. After air-drying, 91.11 g of product was obtained as a white solid. The mother liquor (without heptane) was stripped down in vacuo until a thick slurry was formed, and the resulting precipitate was filtered and rinsed twice with EtOAc (100 mL×2) and once with heptane (100 mL) to give another 16.84 of product as a white solid. Overall yield 78%. [0148] 1 H NMR (DMSO-d 6 ): δ 9.98 (1H, s), 8.24 (2H, s), 7.80 (2H, d, J=6.8 Hz), 7.66 (1H, s), 7.28 (2H, d, J=6.8 Hz), 5.20 (2H, s), 4.67 (2H, m), 3.32 (1H, m), 3.01 (2H, m), 2.43 (2H, q, J=7.2 Hz), 2.07 (2H, m), 1.59 (2H, m), 1.11 (3H, t, J=7.2 Hz) ppm. All the remaining mother liquors were combined, and concentrated in vacuo to give 15.07 g of an off-white solid which would be purified by one more time recrystallization with EtOAc or chromatography with 70% EtOAc/hexanes on silica gel. [0149] This reaction was also tried at a small scale (0.6 mmol) at higher concentrations (0.6 M with 2 eq. of pyrimidine and 1.2 M with 1.3 eq. of pyrimidine). [0150] Free amine (207 mg, 0.60 mmol) was treated at 90° C. with 178.3 mg of 2-chloro-5-ethylpyrimidine (2 eq.) and anhy. K 2 CO 3 (1.5 eq.) in 1 mL of DMF (the final concentration of the free amine is ˜0.60 M). The reaction was complete in 2 hours. However, the reaction mixture was not homogenous at the end because of the precipitation of product. [0151] Free amine (212 mg, 0.62 mmol) was treated at 90° C. with 114.2 mg of 2-chloro-5-ethylpyrimidine (1.3 eq.) and anhy. K 2 CO 3 (1.5 eq.) in 0.5 mL of DMF (the final concentration of the free amine is ˜1.2 M). The reaction was achieved ˜85% conversion in 2 hours, and the reaction mixture was not homogenous because of the precipitation of product. Significant amount of the unidentified by-products were formed after heating at 90° C. for 4 hours. Example 7 [0152] 4-Tetrazol-1-yl-phenol [0153] To a Kimax tube (25×150 mm) were added 4-aminophenol (200 mg, 1.83 mmol), sodium azide (167 mg, 2.57 mg, 1.4 eq.), acetic acid (1 mL), 2 drops of concentrated hydrochloride acid, and trimethyl orthoformate (0.5 mL) at room temperature. The mixture was stirred, and heated up to 100° C. on a heating block. After at 100° C. for 20 min, the temperature was lowered to 80° C., and water (1 mL) was added. When the mixture was cooled down to room temperature, the liquids were removed using pipette. The solid was washed with water (1 mL×3) and heptane (1 mL), and tried under vacuum. The white solid was used in the next step without further purification. [0154] TLC: hexane-ethyl acetate 50:50, Rf (product)=0.28; Rf (starting material)=0.23, UV and iodine positive. [0155] 1 HNMR (400 MHz, D 3 COD), δ 9.58 (s, 1H), 7.61 (d, J=9.0 Hz, 2H), 6.97 (d, J=9.0 Hz, 2H) ppm. [0156] To the same tube from above reaction (with the synthesized 4-tetrazol-1-yl-phenol in) were added 2-[4-(4-Chloromethyl-thiazol-2-yl)-piperidin-1-yl]-5-ethyl-pyrimidine (571-110, 532 mg, 1.65 mmol), Cs 2 CO 3 (596 mg, 1.83 mmol), KI (14 mg) in acetonitrile (2 mL). The mixture was heated at 60° C. for 10 hours (The reaction was followed by HPLC/MS). [0157] After cooling the reaction mixture was treated with ethyl acetate (100 mL) and water (20 mL). The water phase was separated out. The organic phase was washed with brine (20 mL), dried over anhydrous sodium sulfate, concentrated. The residue was dissolved in small amount of dichloromethane and purified by 40 g silica gel Combiflash column to afford 580 mg (70% yield in two steps) of desired product as white solid. [0158] 1 H NMR (DMSO-d 6 ): δ 9.98 (1H, s), 8.24 (2H, s), 7.80 (2H, d, J=6.8 Hz), 7.66 (1H, s), 7.28 (2H, d, J=6.8 Hz), 5.20 (2H, s), 4.67 (2H, m), 3.32 (1H, m), 3.01 (2H, m), 2.43 (2H, q, J=7.2 Hz), 2.07 (2H, m), 1.59 (2H, m), 1.11 (3H, t, J=7.2 Hz) ppm. MS (ESI), m/z 449. Example 8 Melt Extrusion Formulations [0159] Solid dispersion formulations were prepared using the Leistritz 16-mm extruder, examining the effect of polymer type, drug loading and processing temperature on the critical product attributes of Compound A solid dispersions. Exemplifying process conditions and formulation variables are presented in Table 1. [0000] TABLE 1 Processing Parameters Used For Production of Compound A Solid Dispersion Formulations by Melt Extrusion on the 16-mm Extruder Barrel Loading Temperature Screw Speed Formulation (mg/g) Polymer (° C.) (rpm) 1 250 HPMCAS-MF 125 250 2 250 Eudragit ® E PO 125 250 3 250 Kollidon ® VA 64 125 250 4 250 Eudragit ® L100-55 160 100-250 5 400 Kollidon ® VA 64 130 250 6 400 Eudragit ® E PO 130 250 HPMCAS-MF indicates M grade Hypromellose Acetate Succioate supplied as a fine power [0160] Solid dispersion formulations of Compound A in Eudragit® E PO (Formulation 2) and Kollidon® VA 64 (Formulation 3) were examined for dissolution behavior under non-sink conditions to assess oral bioavailability enhancement. Studies were conducted in three different media preparations, including: simulated gastric fluid, fed state simulated intestinal fluid and fasted state simulated intestinal fluid, which are presented in Table 2, Table 3 and Table 4 and FIG. 1 , FIG. 2 and FIG. 3 . [0000] TABLE 2 Non-Sink Dissolution Performance of Compound A Melt Extruded Formulations Tested in Simulated Gastric Fluid Compound A Compound A Extrudate in Extrudate in Compound A Eudragit ® VA 64, Kollidont ® VA 64, Formulation Crystalline 250 mg/g 250 mg/g C max 0.247 1.547 1.307 (mg/mL) T max (hr) 2 0.08 0.5 AUC 0-2 hr 0.321 2.484 2.454 (mg*hr/mL) AUC 0-4 hr 0.727 4.931 5.021 (mg*hr/mL) AUC 0-24 hr 4.494 27.324 29.714 (mg*hr/mL) [0000] TABLE 3 Non-Sink Dissolution Performance of Compound A Melt Extruded Compositions Tested in Simulated Fed State Intestinal Fluid Compound A Compound A Extrudate in Extrudate in Compound A Eudragit ® VA 64, Kollidont ® VA 64, Formulation Crystalline 250 mg/g 250 mg/g C max 60.182 71.649 188.372 (μg/mL) T max (hr) 2 24 4 AUC 0-2 hr 100.045 91.584 307.367 (μg*hr/mL) AUC 0-4 hr 211.597 220.744 667.833 (μg*hr/mL) AUC 0-24 hr 1148.003 1631.674 4294.733 (μg*hr/mL) [0000] TABLE 4 Non-Sink Dissolution Performance of Compound A Melt Extruded Compositions Tested in Simulated Fasted State Intestinal Fluid Compound A Compound A Extrudate in Extrudate in Compound A Eudragit ® VA 64, Kollidon ® VA 64, Formulation Crystalline 250 mg/g 250 mg/g C max 29.891 10.122 38.858 (μg/mL) T max (hr) 0.50 0.08 0.50 AUC 0-2 hr 51.205 9.964 71.508 (μg*hr/mL) AUC 0-4 hr 103.281 16.145 143.005 (μg*hr/mL) AUC 0-24 hr 434.380 71.762 768.998 (μg*hr/mL) Example 9 Spray-Dried Dispersion Formulation with 25% of Compound A [0161] The spray drying process includes preparation of the spray solution to dissolve Compound A and cellulose acetate phthalate (CAP), spray drying to form spray-dried dispersion (SDD) powder, and secondary drying of the SDD powder to remove residual solvent. FIG. 4 provides an overview of the process used to manufacture the 25% SDD formulation containing 250 mg/g of Compound A and 750 mg/g of CAP (referred to as 25% Compound A: CAP SDD) on a PSD-1 spray dryer. [0162] Spray Solution Preparation: [0163] During spray solution preparation the temperature of the solution is maintained at room temperature but above 20° C. to ensure the solubility of Compound A. After Compound A is added to the acetone, the solution is mixed for at least one hour, until the crystalline Compound A is completely dissolved. The CAP is then added to the solution and mixed for at least one hour until the CAP is completely dissolved. The spray solution contains 1.25% of Compound A, 3.75% of CAP and 95% of acetone. [0164] Spray Drying: [0165] The spray-drying conditions are divided into preheating, warm-up/shutdown and feed-solution processing phases. During the warm-up phase pure acetone is sprayed to thermally equilibrate the spray dryer. During the feed-solution processing phase the Compound A:CAP spray solution is sprayed. [0166] The operating conditions for the three phases are summarized in Table 5. [0000] TABLE 5 Spray-Drying Conditions for Manufacture of 25% A Compound A:CAP SDD Process Process Parameters Target Target Range (A) Preheating Nitrogen drying-gas flow 1850 g/min 1550 to 2150 g/min T in 125° C. 115° C. to 135° C. (B) Warm-Up/ Nitrogen drying-gas flow 1850 g/min 1550 to 2150 g/min Shutdown T in 125° C. 155° C. to 135° C. T out 47° C. 42° C. to 52° C. Acetone atomization pressure 295 psi 195 to 395 psi Acetone feed rate 195 g/min 160 to 200 g/min (C) Feed-Solution Nitrogen drying-gas flow 1850 g/min 1550 to 2150 g/min Processing T in 125° C. 115° C. to 135° C. T out 45° C. 40° C. to 50° C. Solution atomization pressure 315 psi 215 to 415 psi Solution feed rate 215 g/min 200 to 230 g/min [0167] In one embodiment, the spray-drying conditions are: pressure nozzle: SK 76-16 drying-gas inlet temperature (t in ): 125° C.±10° C. dryer outlet temperature (t out ): 45° C.±5° C. nitrogen drying-gas flow: 1850±300 g/min solution feed rate: 215±15 g/min atomization pressure: 315±100 psig product collection: 6-inch outer-diameter cyclone solution feed filter: ≦230 μm [0176] Secondary Drying: [0177] The SDD powder is spread evenly on open trays and placed in a tray dryer and dried overnight to remove residual acetone (in-process control: residual acetone <0.2%). Drying parameters are listed below: Tray Dryer Type: Convection Tray Dryer Temperature: 40° C.±5° C. Tray Dryer Relative Humidity (RH): 15% to 30% RH±15% Drying Time: 24 hr Bed Depth: ≦2.5 cm [0183] FIG. 5 illustrates the residue acetone content as a function of tray-drying time at 40° C./30% RH for 25% Compound A:CAP SDD based on headspace gas chromatography (GC) analysis under conditions having a tray-dryer bed depth of equal to or less than 2.5 cm. [0184] In one example, a spray solution was formed containing 1.25 wt % Compound A, 3.75 wt % CAP, and 95% acetone as follows. Compound A was added to acetone in a stainless-steel solution tank with a top-mounted mixer, and mixed for at least 1 hour. Next, CAP was added directly to this mixture, and the mixture stirred for at least one additional hour. The resulting mixture had a slight haze after the entire amount of polymer had been added. This mixture was then filtered by passing it through a filter with a screen size of 230 μm to remove any large insoluble material from the mixture, thus forming the spray solution. [0185] The spray-dried dispersion was then formed using the following procedure. The spray solution was pumped to a spray drier (Niro type XP Portable Spray-Dryer with a Liquid-Feed Process Vessel [PSD-1]) equipped with a pressure swirl atomizer (Spraying Systems Pressure Nozzle and Body (SK 76-16)). The PSD-1 was equipped with a 9-inch chamber extension to increase the vertical length of the dryer. The spray drier was also equipped with a diffuser plate having a 1% open area to direct the flow of the drying gas and minimize product recirculation within the spray dryer. The nozzle sat flush with the diffuser plate during operation. The spray solution was pumped to the spray drier at about 215 gm/min at a pressure of about 315 psig. Drying gas (e.g., nitrogen) was circulated through the diffuser plate at an inlet temperature of about 125° C. The evaporated solvent and wet drying gas exited the spray drier at a temperature of 45±5° C. The SDD formed by this process was collected in a cyclone. [0186] Solid non-crystalline dispersions of 10 or 25% Compound A with HPMCAS-MG was also prepared. [0187] Long-term storage of the SDD may be at an average of 5° C. (e.g., 2° C. to 8° C.) in double low-density polyethylene (LDPE) bags inside HDPE drums with desiccant between the two bags. The SDD may be stored for short-term, e.g., 1 week, at ambient temperature and humidity (e.g., 25° C./60% RH). Example 10 In Vitro Analysis of Spray-Dried Dispersion Formulation with 25% of Compound A 1. Physical Properties [0188] Table 6 lists the general physical properties of a 25% Compound A:CAP SDD manufactured from an acetone solution. [0000] TABLE 6 Physical Properties of 25% Compound A:CAP SDD Parameter Value Morphology Smooth collapsed spheres Appearance White powder Volumetric mean particle diameter D(4,3) (μm) 25 DV 10 , DV 50 , DV 90 *(μm) 8, 22, 48 Span (DV 90 − DV 10 )/DV 50 1.9 Bulk specific volume (cc/g) 7.5 Tapped specific volume (cc/g) 3.7 Glass-transition temperature (T g ) (° C.) 114 Crystallinity non-crystalline * 10 vol % of the particles have a diameter that is smaller than D 10 ; 50 vol % of the particles have a diameter that is smaller than D 50 , and 90 vol % of the particles have a diameter that is smaller than D 90 . 2. Potency/Purity [0189] The potency and purity of the SDD were assessed by high-performance liquid chromatography (HPLC), which indicated that SDD prepared from an acetone solution did not significantly change the purity of Compound A and the potency was similar to the theoretical potency of the formulation. 3. Dissolution Performance [0190] In vitro performance was evaluated using an in vitro dissolution test performed at a theoretical C max of 200 μg/mL of Compound A in NaTC/POPC in PBS (pH 6.5), wherein C max is maximum observed concentration; NaTC/POPC is 3.7/1 sodium taurocholate/l-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine and PBS is phosphate buffer solution. Samples were weighed, dissolved in the buffer system, centrifuged, and the supernatant analyzed by HPLC at 10, 20, 40, and 90 minutes. [0191] Tables 7a and 7b and FIG. 6 compares in vitro dissolution performance of Compound A:CAP SDD with that of crystalline of Compound A, HPMCAS-MG, and HPMCAS-HG. As the figure shows, the C max and AUC 0-90 (area under the curve through 90 minutes) of the SDD were more than 6-fold higher than those of crystalline of Compound A. [0000] TABLE 7a C max AUC 0-90 Formulation tested (μg/mL Compound A) (μg*min/mL) 25% Compound A: CAP SDD 73 5,850 Crystalline Compound A 12 950 [0000] TABLE 7b (Simulated gastric fluid) Dose C max90 AUC 90 Sample Polymer (μg/mL) (μg/mL) (min*μg/mL) 25% Dispersion HPMCAS-MG 200 29 3600 25% Dispersion HPMCAS-HG 200 25 3700 10% Dispersion HPMCAS-HG 200 26 4700 Crystalline — 200 8 1000 The concentrations of Compound A obtained in these samples were used to determine the maximum concentration of Compound A (“C max90 ”) and the area under the concentration-versus-time curve (“AUC 90 ”) during the initial ninety minutes. Example 11 In Vivo Performance [0192] In vivo testing was performed in male dogs to compare the systemic exposure of the 25% Compound A:CAP SDD (n=2) to that of the crystalline Compound A (n=2). As shown in Table 8, the 25% Compound A:CAP SDD provided a enhanced systemic exposure over bulk crystalline drug in male beagle dogs dosed at 10 mg/kg and 200 mg/kg Compound A orally. [0000] TABLE 8 In Vivo Results for 25% Compound A:CAP SDD and Micrometersized Compound A Crystals Enhancement Crystalline SDD of SDD/ AUC 0-24 hr C max AUC 0-24 hr C max Crystalline Dose (μg * h/mL) (μg/mL) (μg * h/mL) (μg/mL) AUC C max  10 mg/kg 3.9 0.56 13.9 2.24  3.6x 4.0x 200 mg/kg 17 2 216 11.8 12.7x 5.9x Example 12 Tablets [0193] Tablet manufacture includes blending the SDD and intragranular excipients to form a uniform blend, dry-granulating to form flowable granules, blending extragranular excipients to provide additional tableting functionality, tablet compressing to form unit dosages, and film-coating to provide a white opaque coating. The excipients used in the 25 and 100 mg tablets are shown in Tables 9 and 10, respectively. A sufficient amount of the solid dispersion of compound A was used to provide for 25 mg of the compound in the 25 mg tablet, and a sufficient amount of the solid dispersion of compound A was used to provide for 100 mg of the compound in the 100 mg tablet. FIG. 7 provides an overview of the manufacturing process for the uncoated 25 mg tablets. FIG. 8 provides an overview of the manufacturing process for the uncoated 100 mg tablets. [0000] TABLE 9 Composition of 25 mg Tablet Compound A Microcrystalline cellulose (Avicel PH-101, FMC); intragranular Lactose monohydrate, modified spray-dried (316 FastFlo, Foremost); intragranular Crospovidone (Polyplasdone XL, ISP); intragranular Magnesium stearate (vegetable sourced); intragranular Crospovidone (Polyplasdone XL, ISP); extragranular Lactose monohydrate, modified spray-dried (316 FastFlo, Foremost); extragranular Microcrystalline cellulose (Avicel PH-200, FMC); extragranular Colloidal silica dioxide (Cab-O-Sil M5P, Cabot); extragranular Magnesium stearate (vegetable sourced); extragranular [0000] TABLE 10 Composition of 100 mg Tablet Component Compound A Microcrystalline cellulose (Avicel PH-101, FMC); intragranular Lactose monohydrate, modified spray-dried (316 FastFlo, Foremost); intragranular Crospovidone (Polyplasdone XL, ISP); intragranular Magnesium stearate (vegetable sourced); intragranular Colloidal silica dioxide (Cab-O-Sil M5P, Cabot); extragranular Magnesium stearate (vegetable sourced); extragranular [0194] The same blending and dry-granulation process is used for the 25 mg and 100 mg active tablets (i.e., a “common granulation” is used for both tablet strengths). The 25 and 100 mg uncoated tablets may have identical size, shape and weight. Optionally, the 25 mg and 100 mg tablets can be coated using a film coating compositions well known to those of skill in the art, for example, Opadry II (white 85F18378, Colorcon) and purified water. Dry Granulation [0195] The dry granulation process is carried out as follows: 1. The intragranular excipients are delumped by passing through a low-shear cone mill. 2. The delumped excipients, and the 25% Compound A:CAP SDD are added to the bin blender and blended. 3. The magnesium stearate is hand screened with a portion of the blend from step 2 into the bin blender and blended. 4. The blend is discharged from the blender and roller-compacted. The roller compactor parameters are established to provide roller compacted material with a solid fraction (a unitless relative density parameter) of 0.63. This is assured by in-process measurement. 5. The roller compacted material is granulated by passing through a 0.8 mm oscillating screen mill. The granulation from step 5 is called the “Common Granulation” and is used to manufacture both the 25 and 100 mg active tablets. [0201] The extragranular final blend and tablet compression are carried out as follows: 1. The required amounts of extragranular excipients are calculated. 2. For the 25 mg active tablets only, the granulation, extragranular lactose and extragranular microcrystalline cellulose are added to the bin blender and blended. 3. The colloidal silica dioxide is hand screened with a portion of the blend from step 2 into the bin blender and blended. 4. The magnesium stearate is hand screened with a portion of the blend from step 3 into the bin blender and blended. 5. The powder is discharged from the blender and compressed into 800 mg total weight tablets using a rotary tablet press. The tablet weight, tablet weight distribution and tablet hardness are adjusted during startup and are monitored at timed intervals during compressing to assure product attributes are met. 6. The tablets are de-dusted, passed through a metal detector and stored in double polyethylene bags in drums. [0208] In-process controls of tablet preparation: Tableting—Dry Granulation: [0209] Solid Fraction (Relative Granulation Density): 0.63±0.03 (dimensionless). Tableting—Compression: [0000] Appearance: Absence of visual defects Mean Tablet Weight: Working Range±3% of Target, Alert Range±6% of Target Weight Uniformity: <4% RSD Tablet Hardness: Working Range 18-22 kP, Alert Range 16-24 kP. [0214] In one particular example, crospovidone, lactose monohydrate, and microcrystalline cellulose were delumped using a comil 197 equipped with a 0.032-inch (032R) screen and 1601 impellor. The spray-dried dispersion was added to the delumped mixture and blended using a PK twin-shell blender, followed by addition and blending of the magnesium stearate, to form the intragranular blend. Next, the intragranular blend was roller compacted and milled into granules using a Gerteis Mini-Pactor with a Gerteis Star Rotor Mill with a 0.8 mm screen, a compression force between 4 and 7 kN/cm, and a roll speed between 2 and 6 rpm. The milled granulation was blended with colloidal silica dioxide, followed by the addition and blending of the extragranular magnesium stearate. Tablets were compressed using a Kilian T-100 rotary press with 0.3586″×0.7174″ modified oval tooling to a hardness of 17-23 kP. Example 13 Film-Coating of Tablets [0215] The aqueous film-coating process is the same for the 25 and 100 mg active tablets, which is described below and illustrated in FIG. 9 . 1. The Opadry II powder is added to Purified Water and stirred until no lumps remain. 2. The coating pan is pre-warmed and then the empty pan is spray-coated with a thin layer of Opadry II to eliminate sliding of tablets during film-coating. 3. Tablets are added to the pan and pre-warmed. 4. The tablets are film-coated and the coating suspension is stirred throughout the coating process to prevent settling. 5. When the coating process is complete, the tablets are dried with jog tumbling. 6. Finished, coated tablets are stored in double polyethylene bags in drums. [0222] In one particular example, a coating solution was formed by adding Opadry II to purified water (1:9 wt:wt) in a mixing vessel with overhead propeller stirrer. The coating solution was pumped using a peristaltic pump to a Schlick 970 spray gun with 1.0-mm nozzle and standard air cap, and the tablets were coated in a Vector LDCS pan-coater. The following conditions were used: atomizing air pressure 15 psi, nozzle tip-to-bed distance 2.5″, inlet air flow 45 CFM, inlet-air temperature 70 to 75° C., exhaust temperature 46° C., pan run speed 20 rpm, and solution flow rate 9 g/min. Coated tablets had a hardness of 20 kP. Sink Dissolution Test [0223] A sink dissolution test was performed on 100-mgA Film-Coated SDD tablets. 900 mL dissolution media (0.05 M NaH 2 PO 4 , pH 6.8, containing 1 wt % sodium lauryl sulfate) was added to 1000 mL VanKel dissolution vessels and allowed to warm up for about 30 minutes. Tests were performed at 37° C. Four tablets were dropped into individual vessels containing the dissolution media at time 0. The theoretical maximum concentration of Compound A in the dissolution media was 11 μg/mL. Samples (10 mL) were taken at 5, 15, 30 and 45 minutes using 20 mL syringes with cannulas equipped with 10 μm full flow filters. The samples were filtered through a 0.45 μm nylon syringe filter into an HPLC vial for analysis. The results are shown in Table 11. The 100 mg tablets released 98.3% of theoretical by 45 minutes. Tablets were greater than 80% dissolved within 5 minutes. [0000] TABLE 11 Sink Dissolution of 100-mg Film-Coated SDD Tablets (average of 4 tablets) 100-mg Film-Coated SDD Tablets Time Average Compound Std dev Average % released Std dev % (min) A Released (mg) (mg) (of theoretical) released 0 0.0 0.0 0.0 0.0 5 81.8 0.7 81.8 0.7 15 96.2 0.1 96.2 0.1 30 93.6 5.9 93.6 5.9 45 98.3 0.2 98.3 0.2 [0224] The tablets can be packed in high-density polyethylene (HDPE) bottles with polypropylene heat-induction seal caps and desiccant. Bottles can be labeled with the lot number, content, storage conditions and other information as required. Example 14 In Vivo Results Methodology: Study Design [0225] This is a single center, phase 1, double-blind, placebo-controlled, multiple ascending dose study of Compound A given orally as a reformulated tablet (spray dried dispersion, or SDD) to otherwise healthy subjects with “pre-diabetes” (impaired fasting glucose, impaired glucose tolerance, or HbA1C≧5.8), or diet-controlled type 2 diabetes mellitus. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and proof-of-concept pharmacodynamics of Compound A. Each dosing cohort consisted of a screening period to assess eligibility, a dosing and observational period, and a follow-up period. [0226] The screening visit was used to assess preliminary eligibility in potential subjects who provided informed consent. Final eligibility for study enrollment was determined after check-in to the clinic on Day −3, before randomization and dosing (on Day 1). Eleven eligible subjects who successfully completed screening were enrolled into the lowest dose cohort that was yet to be filled, and randomly assigned in a double-blind fashion to receive Compound A (n=8) or matched placebo (n=3). Up to 4 additional subjects were admitted to the clinic and available as back-ups in the event that 1 of the original 11 subjects was not dosed for any reason. [0227] Each of these study cohorts was enrolled and completed independently, and in sequential fashion. After completion of the inpatient observational period at Day 8, blinded clinical safety and laboratory parameters (including PK) were assessed in a teleconference between the Principal Investigator, or Sub-Investigator, and the Metabolex Medical Monitor, after which subject dosing assignments could have been unblinded, if necessary, for determination of dose-limiting toxicities (DLTs). If two dose-limiting toxicities (DLTs) occurred within the same treatment cohort in subjects receiving active drug, no further dose escalation would have been allowed, and the maximum tolerated dose (MTD) would have been defined by the dose in the previous cohort. Additionally, dosing may have been halted at the discretion of the sponsor depending on observed Compound A concentrations and PK parameters from the preceding cohort in context of the safety and pharmacodynamic profile of the preceding cohorts. Study Procedures Screening Phase (Day −35 to −3) [0228] The initial screening visit occurred between Day −35 and Day −4, before the start of each new dose cohort, to determine subject eligibility. At the initial screening visit, subjects signed an informed consent prior to any study specific assessments or assignment of a screening number. Screening evaluations included collection of demographics and a full medical history with medication review, 12-lead ECG and vital signs (including height and weight), drug and alcohol screen, serum pregnancy test (females only), clinical laboratory evaluation and HbA1c. A minimum of 15 subjects who satisfied initial screening eligibility assessments were invited to complete the Day −3 assessments. Subjects returned to the clinic three days prior to scheduled drug administration (Day −3) for a repeat safety and final eligibility evaluation consisting of vital signs (including weight), ECG, complete physical examination including funduscopic examination, clinical laboratory evaluation, repeat drug and alcohol screen, repeat serum pregnancy test (females only) and review of concomitant medications and interval medical history. Each subject underwent a final eligibility review and up to 15 fully eligible subjects were admitted to the clinic overnight. Dosing, Observation, and Assessment Period (Day −2 to Day 8) [0229] On Day −2, following a 10 hour overnight fast, up to 15 eligible subjects underwent a baseline MMTT administered between 9:30 and 10:15 am, for the assessment of glucose and insulin response and of total GLP-1 and glucagon. On Day −1, following a 10 hour overnight fast, up to 15 eligible subjects also underwent a baseline OGTT (75 g) administered at the identical time of day as the MMTT, for assessment of the same markers. After the baseline OGTT assessments, 11 subjects were enrolled and randomized into the current dosing cohort. Up to 4 additional subjects remained overnight to be available as back-ups in the event that 1 of the original 11 subjects was, for any reason, not dosed. If more than 11 eligible subjects meet the cohort requirements, the excess subjects may have been included in the next cohort check-in, if within the 35 day screening window and they continued to meet eligibility. On Days 1 through 5, following a 10 hour overnight fast, subjects received daily doses of Compound A or placebo exactly 2 hours earlier than the start of the baseline MMTT, under fasted conditions. The inpatient period in clinic began on Day −2 and concluded on Day 8, following the final inpatient study procedure. The following assessments were made in temporal relationship to the administration of the study drug, administered at Day 1, Time 0, unless otherwise stated: Pharmacokinetic Blood and Urine Sampling: Subjects randomized to Compound A or placebo underwent single dose (Day 1) and repeat dose (Day 4) PK. Compound A was measured pre-dose (t −30 and 0 min) on Day 1 and at 20 and 40 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose. Compound A was measured at identical timepoints associated with the Day 4 dose, but included additional measurements at 48 and 72 hours post-dose (Day 7). Additionally, a 24 hour urine collection was completed on Day 4 for potential measurement of Compound A and its metabolites. Safety Assessments: AE's: reviewed and recorded just before study drug administration and twice daily during the inpatient observational period (through Day 8) Complete physical examination including funduscopic examination: Day 6 Vital signs: Days −2, −1, Days 1 through 5 (immediately pre-dose and at 15, 30, and 60 minutes and 2, 4, and 12 hours post-dose), and Days 6, 7, and 8 ECG: Days 1 through 5 (immediately pre-dose and at 2, 4, and 12 hours post-dose), and Days 6, 7, and 8 Clinical laboratory: on Days 1 (pre-dose), 2, 4, 6, and 8. Concomitant medication review and recording of all medications used since screening, at every visit beginning at Day −2 and through the observational period. Pharmacodynamic Blood Sampling: An MMTT was administered at baseline (Day −2 pre-dose) and at 2 hours after the Day 4 dose, at the identical time on each occasion. Glucose, and insulin were obtained from 7 measurements performed at 30 minutes before the meal, immediately before the meal (0 minutes), and 30, 60, 90, 120, and 240 minutes after starting the meal. Total GLP-1 and glucagon were obtained from 11 measurements performed at 30 minutes before the meal, immediately before the meal (0 minutes), 10, 15, 20, 30, 40, 60, and 90 minutes after starting the meal, and at 2 and 4 hours after starting the meal. A 75 g OGTT was administered at baseline (Day −1 pre-dose) and at 2 hours after the Day 5 dose, at the identical time on each occasion. Glucose and insulin were obtained from 7 measurements performed at 30 minutes before the glucose ingestion, immediately before the glucose ingestion (0 minutes), and 30, 60, 90, 120, and 240 minutes after the glucose ingestion. Total GLP-1 and glucagon were obtained from 11 measurements performed at 30 minutes before the meal, immediately before the meal (0 minutes), 10, 15, 20, 30, 40, 60, and 90 minutes after starting the meal, and at 2 and 4 hours after starting the meal. Fasting Glucose: Day 1 pre-dose (2 samples, 5 minutes apart) and Day 5 pre-dose (2 samples, 5 minutes apart) Remaining sample material was banked for possible, future exploratory analyses related to this compound. Follow-Up Visit (Day 15±1 Days) [0244] This visit included vital signs, full physical examination including funduscopic examination, clinical laboratory evaluation, serum pregnancy test (females only), ECG, concomitant medication review, and review of ongoing AE's. The completion of this visit marked the end of the subject's formal participation in the study. Number of Patients (Planned): [0245] 11 Subjects (8 active, 3 placebo) were to be randomized into the dosing phase of each of the four dosing cohorts of this study, for a total of 44 subjects. Key Eligibility Criteria [0000] Healthy, ambulatory, adult male and female volunteers between 18 to 60 years of age with no significant medical history as judged by the Investigator History of type 2 diabetes mellitus allowed if diet-controlled and not treated with insulin or oral glucose lowering agents within 3 months of screening Fasting glucose≧100 mg/dL and ≦150 mg/dL or 2 hour post OGTT (75 g) glucose>140 mg/dL or HbA1c≧5.8% at screening Fasting glucose≦105 mg/dL if HbA1c is <5.8% at screening HbA1c between 5.5% and 7.5% BMI 25 to 45 kg/m2 (inclusive) No prior history of bariatric surgery All clinical laboratory test results must have been within normal range or considered not clinically significant ECG must have been normal or without clinically relevant pathology as judged by the Investigator; all vital signs including blood pressure must have been within normal limits Investigational Product, Dosage and Mode of Administration: [0255] Compound A (25 mg and 100 mg tablets) or Matched Placebo. Table 12 shows the baseline demographics of the Phase 1c study. [0256] Dose/Route/Regimen: Cohort 1: 25 mg (25 mg×1) orally once daily for 5 days Cohort 2: 100 mg (100 mg×1) orally once daily for 5 days Cohort 3: 300 mg (100 mg×3) orally once daily for 5 days Cohort 4: 600 mg (100 mg×6) orally once daily for 5 days [0261] Duration of Treatment: Screening Period: Up to 33 days (Day −35 to Day −3) Dosing and Observational Period: 10 days (Day −2 to Day 8) Follow-up Phase: 7 days (Day 9 to Day 15) [0000] TABLE 12 Baseline Demographics Com- Com- Com- Com- Pooled pound A pound A pound A pound A Placebo 25 mg 100 mg 300 mg 600 mg N 1   11 2 8 8   7 2 8 Female (%) 45% 38% 38% 71% 38% Age (years) 44 34 47  42 41 Screening 95 96 105 110 94 FPG (mg/dL) Screening 115  136 152 135 120 2 h OGTT (mg/dL) IFG or IGT 3 4 (36%) 3 (38%) 5 (63%) 3 (43%) 2 (25%) N(%) Screening   6.1 6.1 6.1     6.0 6.1 HbA1C (%) BMI   32.2 31.3 32.2   32.9 32.5 (kg/m2) 1 Per Protocol 2 300 mg Cohort: one active and one placebo subject were excluded due to dosing error 3 With HbA1c ≧ 6.0% Pharmacokinetic Results [0265] In this study, single escalating doses (4 cohorts) of the SDD formulation of Compound A, administered in the fasted state, were well absorbed and led to a relatively linear dose-dependent increase in C max and exposure at all doses administered. Relative to single doses of the microcrystalline formulation, exposure was enhanced by up to 4.2-fold at the top dose (600 mg). Relative to single doses, repeat daily dose PK (Day 5) showed modest accumulation (˜2-fold) but by Day 5 steady-state drug levels were nearly achieved. The repeat dose 24 h exposure at the highest dose (600 mg) was ˜8-fold higher than the maximum exposure previously achieved with the microcrystalline formulation. The repeat dose half-life was consistent with once daily dosing. A summary of the repeat dose (Day 5) concentration-time profile and PK parameters, by dosing group, is presented in FIG. 10 and Table 13, respectively. A comparison of the AUC and C max for the SDD formulation and the microcrystalline formulation are shown in FIGS. 11 and 12 , respectively. [0000] TABLE 13 Mean (±SD) Pharmacokinetic Parameters after Administration of Repeat (5) Daily Doses of Compound A to Healthy Subjects with Pre-Diabetes Treatment Parameter Microcrystalline (Units) 25 mg 100 mg 300 mg 600 mg 600 mg C max  346  1153  2330  3565  437 (ng/mL)  (127)  (228)  (558)  (835) T max    5.4      2.8      2.2      3.3 N/A (hr)    (1.8)      (2.1)      (1.8)      (1.8) T 1/2     14.0     18.3    15.3 N/A N/A (hr)     (4.53)     (8.92)     (3.03) AUC 0-24 h 4150 13336 30027 57859 7000 (ng*hr/mL) (2412)  (2706)  (9148) (16152) AUC 0-inf 6497 24618 45019 N/A N/A (ng*hr/mL) (5026) (10835) (14068) Pharmacodynamic Results [0266] In the studies that have been conducted to date, Compound A consistently lowered fasting plasma glucose (FPG) and glucose excursion following a mixed meal tolerance test (MMTT) and oral glucose tolerance test (OGTT). Single doses of the microcrystalline formulation of Compound A (600 mg and 1000 mg) in study A, and repeat daily doses of 100 mg and 300 mg over 4 days in study B reduced the glucose excursion in a dose-dependent fashion during a mixed meal tolerance test compared to placebo and/or baseline by 20-40%. Repeat daily doses of the SDD formulation of Compound A at all doses tested in study C (25, 100, 300, and 600 mg) reduced the glucose excursion during a mixed meal and oral glucose tolerance test compared to baseline and placebo. The magnitude of the glucose reduction observed during the MMTT was more pronounced, and ranged between 34 and 51%, as shown in FIG. 13 . With the SDD formulation, the peak glucose effects appeared to be observed at the 100 and 300 mg doses, while dosing of 600 mg (up to exposures of >50,000 ng*h/mL) did not result in additional glucose lowering in this population of early pre-diabetics. At baseline, subjects in the 600 mg group had better glycemic tolerance than the other groups, which likely explains the apparent lower magnitude of effect at this dose. [0267] Reductions in glucose were greatest in the subsets of subjects with the greatest degree of glucose intolerance at baseline (up to 77% reduction, net of placebo). This is exemplified by a pooled subanalysis of subjects receiving any dose of Compound A in Phase 1c (study C), as depicted in FIG. 14 .

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a divisional of U.S. patent application Ser. No. 10/283,873, entitled “Linearly Expandable Ureteral Stent,” filed Oct. 30, 2002 (now abandoned), the entirety of which is incorporated herein by reference. BACKGROUND The invention generally relates generally to medical devices for the drainage of fluids, and more specifically to ureteral stents. A ureter is a tubular passageway in a human body that conveys urine from a kidney to a bladder. The ureter begins with the renal pelvis and ends at the trigone region of the bladder, i.e., the triangulated area between both ureteral orifices and the bladder neck. Urine is transported through the ureter under the influence of hydrostatic pressure, assisted by contractions of muscles located within the walls (lining) of the ureter. Some patients experience a urological condition known as ureteral blockage or obstruction. Some common causes of ureteral blockage are the formation of tumors or abnormalities within the ureteral lining, or the formation and passage of kidney stones. Ureteral stents are used to facilitate urinary drainage from the kidneys to the bladder in patients having a ureteral obstruction or injury, or to protect the integrity of the ureter in a variety of surgical manipulations. Stents may be used to treat or avoid ureter obstructions (such as ureteral stones or ureteral tumors) which disrupt the flow of urine from the kidneys to the bladder. Serious obstructions may cause urine to back up into the kidneys, threatening renal function. Ureteral stents may also be used after endoscopic inspection of the ureter. A stent may be uncomfortable to a patient because of intramural tunnel pain, imposed by the stent itself or in combination with intraoperative trauma inflicted from device passage. Pain may also be caused by urine reflux back up the ureter during increased bladder pressure, e.g., during voiding. Further, pain may stem from trigome irritation resulting from constant irritation, imposed by the bladder anchoring features or in combination with intraoperative trauma inflicted from device passage. Moreover, discomfort may arise from flank pain, caused by reflux or kidney anchoring. Ureteral stents typically are tubular in shape, terminating in two opposing ends: a kidney distal end and a bladder proximal end. Existing ureteral stents compensate for the motion between the kidney and bladder by employing a pair of coil end-effectors, with one effector placed in the bladder proximal end and the other in the kidney distal end. As motion occurs, the ureter slides up and down the stent body. Any other travel results in an uncurling of the end effector(s). SUMMARY It is an objective of the invention to provide a patient, male or female, with a flexible device designed to maintain the patency of the ureter and enable fluid drainage while minimizing the pains and discomfort commonly associate with an in-dwelling device. Discomfort may be related to the stent rubbing against a wall of the ureter, caused by the constant relative motion between the kidney and the bladder. This motion may be as much as 5 centimeters (cm) (approximately 2 inches) and cycles with each breath of the patient. This is equal to approximately 17,000 cycles per day, assuming 1 breath every 5 seconds. The present invention alleviates discomfort by providing a stent that, like the ureter, linearly expands and contracts in response to relative motion between the kidney and the bladder, thereby reducing friction caused by a stent rubbing against a wall of the ureter. In one aspect, the invention features a ureteral stent having an elongated member defining a lumen. The member has a solid sidewall defining a spiral-shaped opening such that the member is linearly expandable along a longitudinal axis of the lumen. A distal retention structure is connected to a distal end of the elongated member for retention in a kidney, and a proximal retention structure is connected to a proximal end of the elongated member for retention in a bladder. One or more of the following features may also be included. The member includes a spring having a spring force of less than one pound. The member includes a wire spring. The wire spring includes a metal alloy, that may include at least one of titanium, nickel, copper, cobalt, vanadium, and iron. The metal alloy includes nitinol. The wire spring is coated with a polymer. The polymer includes at least one of urethane, nylon, thermoplastic polyurethane (TPU), thermoplastic polyester elastomer, polyethyl, and silicone. The stent has an elongated member including a tube having the solid sidewall and defining the lumen. The spiral-shaped opening is defined by a slit formed in the sidewall of the tube. The elongated member may include a polymer, such as at least one of urethane, nylon, TPU, thermoplastic polyester elastomer, polyethyl, and silicone. The elongated member includes an inner liner and an outer cover. A wire spring is sandwiched between the inner liner and the outer cover, with the spiral-shaped opening being defined by slits formed in the inner liner and the outer cover, between a plurality of coils of the wire spring. The wire spring includes a metal alloy including, e.g., at least one of titanium, nickel, copper, cobalt, vanadium, and iron. The metal alloy includes nitinol. At least one of the inner liner and the outer cover includes a polymer. The polymer includes at least one of urethane, nylon, TPU, thermoplastic polyester elastomer, polyethyl, and silicone. A removable introducer is sized for placement within the lumen. In another aspect of the invention, a ureteral stent includes an elongated member defining a lumen, the member having a solid sidewall with at least one slit formed therein such that the member is linearly expandable along a longitudinal axis of the lumen. A distal retention structure is connected to a distal end of the elongated member for retention in a kidney, and a proximal retention structure is connected to a proximal end of the elongated member for retention in a bladder. In yet another aspect of the invention, a method of facilitating urinary drainage from a kidney to a bladder in a patient that reduces discomfort to the patient includes positioning a ureteral stent in a ureter of a patient, the ureteral stent having an elongated member defining a lumen, the member having a solid sidewall defining a spiral-shaped opening such that the member is linearly expandable along a longitudinal axis of the lumen, a distal retention structure connected to a distal end of the elongated member for retention in the kidney, and a proximal retention structure connected to a proximal end of the elongated member for retention in the bladder. The elongated member is allowed to linearly expand and contract between an expanded position and a retracted position, based on at least one of: relative positioning of organs within the patient, a breathing pattern of the patient, and relative positions of the kidney and the bladder. In addition, the elongated member can be biased to the retracted position. In yet another aspect of the invention, a method of manufacturing a linearly expandable ureteral stent includes providing an elongated member defining a lumen, the member having a solid sidewall defining a spiral-shaped opening such that the member is linearly expandable along a longitudinal axis of the lumen. The stent also includes a distal retention structure and a proximal retention structure. The distal retention structure is connected to a distal end of the elongated member, and the proximal retention structure is connected to a proximal end of the elongated member. The following features may be included. Providing the elongated member includes providing a wire spring. Providing the wire spring includes coating the wire spring with a polymer. Providing the wire spring includes sandwiching the wire spring between an inner lining and an outer cover. The inner lining and outer cover include extruded sheets. The inner lining and outer cover are shrunk, and slits are formed through the inner lining and outer cover between a plurality of coils of the wire spring. The inner lining and the outer cover are melted, and slits are formed through the inner lining and outer cover between a plurality of coils of the wire spring. The elongated member is provided by forming a tube including a polymer, and forming a spiral slit through the tube. In yet another aspect of the invention, a method of placing a ureteral stent in a patient includes providing a ureteral stent. The ureteral stent includes an elongated member defining a lumen, the member having a solid sidewall defining a spiral-shaped opening such that the member is linearly expandable along a longitudinal axis of the lumen. The ureteral stent also includes a distal retention structure connected to a distal end of the elongated member, and a proximal retention structure connected to a proximal end of the elongated member. The ureteral stent is inserted into a ureter of the patient. The ureteral stent is positioned in the patient with the distal retention structure substantially within the kidney of the patient, the elongated member substantially within the intramural tunnel portion of the ureter, and the proximal retention structure substantially within the bladder of the patient. In a detailed embodiment, the ureteral stent can further include a removable introducer sized to fit within the lumen and inserting the ureteral stent includes inserting the stent with the removable introducer into the ureter. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. FIG. 1A is a schematic view of a human urinary tract, illustrating the placement of one embodiment of the invention within the ureter of a patient, in an expanded position; FIGS. 1B-1C are detailed sectional views of a portion of the embodiment of the invention of FIG. 1A ; FIGS. 2A-2B are schematic representations of the embodiment of the invention illustrated in FIGS. 1A-1C in a retracted position; FIGS. 3A-3B are schematic representations of another embodiment of the invention in an expanded position; FIGS. 4A-4C are schematic representations of the embodiment of the invention illustrated in FIGS. 3A-3B in a retracted position; FIGS. 5A-5C are schematic representations of yet another embodiment of the invention at various stages of fabrication; FIGS. 6A-6C are schematic representations of yet another embodiment of the invention in retracted and expanded positions; and FIG. 7 is a schematic representation of an introducer. DETAILED DESCRIPTION The invention features temporary ureteral stents that, when positioned within the ureter of a patient, significantly reduce discomfort to the patient. As used herein, proximal refers to the end of a stent closest to a medical professional when placing a stent in a patient. As used herein, distal refers to the end of a stent furthest from a medical professional when placing a stent in a patient. Referring to FIG. 1A , a human urinary tract 100 includes a ureter 105 that transports urine from a kidney 110 to a bladder 115 . When ureter 105 becomes blocked or obstructed due to, for example, post-kidney stone fragmentation/removal and ureteral stricture therapy, fluid drainage can become restricted. Ureteral stents are medical devices that are implanted within ureter 105 to restore patency and fluid drainage. A ureteral stent 120 is located within the ureter 105 of a patient, with a distal retention structure 125 in a pelvis 130 of kidney 110 , and a proximal retention structure 135 in the bladder 115 , proximate ureteral orifice 136 . A lumen 137 extends within distal retention structure 25 , an elongated member 140 , and proximal retention structure 135 to provide for the passage of fluid. Distal retention structure 125 is connected to a distal end 142 of elongated member 120 , and proximal retention structure 135 is connected to a proximal end 144 of elongated member 140 . Distal retention structure 125 secures distal end 142 of elongated member in or proximate to kidney 110 . Proximal retention structure 135 secures proximal end 144 of elongated member 140 in or proximate bladder 115 , as well as facilitates the removal of stent 120 by providing a loop suitable for grasping by a hook. Distal retention structure 125 and proximal retention structure 135 can be fabricated of materials such as nylon, polyurethane, or the like. Heat bonding of these materials to elongated member 140 is conveniently accomplished by, for example, using an RF heat source as is commonly employed for plastic tubes and catheters. The desired shape of distal and proximal retention structures 125 , 135 can be formed by injection molding or extrusion. They can also be heat-formed, for example, by flaring the working piece over an anvil of an appropriate shape, with the application of heat. The shape of distal retention structure 125 can be, for example, a coil, a pig-tail coil, J-shaped, or a helical coil. The shape of proximal retention structure 135 can be, for example, a coil, a pig-tail coil, J-shaped or a helical coil. In the illustrated embodiment, both distal and proximal retention structures 125 , 135 are J-shaped. Referring to FIGS. 1A-1C , elongated member 140 includes a tube 145 having a solid sidewall 150 . A slit 155 is formed in sidewall 150 , defining a spiral-shaped opening 160 , so that elongated member 140 is linearly expandable along a longitudinal axis 165 of lumen 137 . Elongated member 140 can be formed from a polymer, such as, e.g., urethane, nylon, TPU, thermoplastic polyester elastomer, polyethyl, and silicone. Elongated member 140 can be manufactured by, for example, injection molding or extrusion and optionally a combination of subsequent machining operations. Extrusion processes, for example, can be used to provide a uniform shape, such as a single monolithic tube. Spiral-shaped opening 160 can be created in the desired locations by a subsequent machining operation. Referring also to FIGS. 2A and 2B , elongated member 140 is linearly expandable between an expanded position (see, e.g., FIGS. 1A-1B ) and a retracted position (see FIGS. 2A-2B ). When elongated member 140 is retracted, spiral-shaped opening 160 is closed. A difference in an expanded length L 1 of elongated member 140 in its expanded position and a retracted length L 2 of elongated member 140 in its retracted position can be approximately 5 cm (approximately 2 inches). For example, elongated member 140 can be sized so that retracted length L 2 is approximately 8 cm to 30 cm, and expanded length L 1 is approximately 13 cm to 35 cm. Elongated member 140 can have, in its retracted position, an outer diameter d 1 corresponding to approximately 3.7 French to 14.0 French. Lumen 137 can have a diameter d 2 when elongated member 140 is in its retracted position, to allow the introduction of a guide wire. In use, elongated member 140 can expand linearly up to 2 inches to expanded length L 1 , to provide comfort to the patient by compensating for at least one of: relative positioning of organs within the patient, a breathing pattern of the patient, and relative positions of kidney 110 and bladder 115 . Because of the possibility of linear expansion, a physician may be able to select ureteral stent 120 with a smaller size than would be required with a conventional stent. Referring to FIGS. 3A-3B , in another embodiment, ureteral stent 300 has an elongated member 310 including a spring 315 . Distal retention structure 125 is connected to a distal end 312 of elongated member 310 , and proximal retention structure 135 is connected to a proximal end 314 of elongated member 310 . Spring 315 has a plurality of coils 320 having, in some embodiments, a spring force less than one pound. Spring 315 includes a wire 325 formed from a superelastic material. Materials with superelastic properties make it possible to configure a component into a particular shape, such as a coil or a sleeve, and then modify reversibly the geometry of the component, such as by straightening it out. Once the device is straightened, after removal of the straightening force, the component reverts spontaneously to its predetermined configuration, thereby regaining its former geometry. In so doing, the component provides a biasing force back to its original configuration. Superelastic materials can include alloys of In—Ti, Fe—Mn, Ni—Ti, Ag—Cd, Au—Cd, Au—Cu, Cu—Al—Ni, Cu—Au—Zn, Cu—Zn—Al, Cu—Zn—Sn, Cu—Zn—Xe, Fe 3 Be, Fe 3 Pt, Ni—Ti—V, Fe—Ni—Ti—Co, and Cu—Sn. Preferably, wire 325 includes a superelastic material comprising a nickel and titanium alloy, known commonly as nitinol, available from Memory Corp. of Brookfield, Conn. or SMA Inc. of San Jose, Calif. The ratio of nickel and titanium in nitinol can be varied. Examples include a ratio of about 50% to about 52% nickel by weight, or a ratio of about 48% to about 50% titanium by weight. Nitinol has shape retention properties in its superelastic phase. Wire 325 can have a coating 330 including a biocompatible material, such as a polymer like urethane, nylon, TPU, thermoplastic polyester elastomer, polyethyl, or silicone. Coating 330 can be applied to wire 325 by various methods, such as spray coating or painting. Ureteral stent 300 has an expanded position (see, e.g., FIGS. 3A-3B ) and a retracted position (see, e.g., FIGS. 4A-4C ). In the retracted position, coils 320 abut each other, defining a lumen 332 that is substantially enclosed. In the expanded position, coils 320 define a spiral-shaped opening 335 , formed by a plurality of gaps 340 between coils 320 . Elongated member 310 is linearly expandable along a longitudinal axis 345 of lumen 332 . Referring to FIGS. 5A-5C , in another embodiment, a stent 500 is formed by placing a wire spring 510 , having a plurality of coils 512 , between an inner lining 515 and an outer cover 520 . Wire spring 510 can be made from a metal alloy including, for example, titanium, nickel, copper, cobalt, vanadium, or iron. The metal alloy can include nitinol, a material including nickel and titanium. Inner lining 515 and outer cover 520 can each be formed from an extruded sheet. Inner lining 515 and outer cover 520 can each be made from a polymer, such as urethane, nylon, TPU, thermoplastic polyester elastomer, polyethyl, and silicone. Inner lining 515 and outer cover 520 are deformed at elevated temperatures to fully surround wire spring 510 . For example, inner lining 515 and outer cover 520 can be shrunk by, e.g., exposure to a heat lamp. Alternatively, inner lining 515 and outer cover 520 can be melted by, e.g., heating in an oven. After deformation, a plurality of slits 525 are formed through inner lining 515 and outer cover 520 between coils 512 to form an elongated member 530 . Elongated member 530 is linearly expandable along a longitudinal axis 535 of a lumen 540 extending through elongated member 530 . Elongated member 530 is connected at a distal end 545 to a distal retention structure 125 , and at a proximal end 555 to a proximal retention structure 135 . Referring to FIGS. 6A-6C , in yet another embodiment, a stent 600 has an elongated member 610 connected to distal retention structure 125 for retention in a kidney and proximal retention structure 135 for retention in a bladder. Elongated member 610 defines a lumen 620 , and has a solid sidewall 625 . Solid sidewall 625 can be made of a biocompatible material, such as a polymer, e.g., urethane, nylon, TPU, thermoplastic polyester elastomer, polyethyl, or silicone. Solid sidewall 625 has at least one slit 630 formed in it, so that elongated member 610 is linearly expandable along a longitudinal axis 635 of lumen 620 . Referring to FIG. 7 , in another aspect, the invention provides an apparatus for delivering a stent into a patient. An introducer 700 includes a guide wire 710 . A proximal end 720 of guide wire 710 includes a grip 725 to assist in using the device. Referring to FIG. 7 and also to FIG. 1A , in use, a stent, (e.g., stent 120 ) is mounted on introducer 700 . Distal retention structure 125 is threaded over guide wire 710 , and most of its inherent curvature is removed. Next, the guide wire 710 is inserted into bladder 115 through ureteral orifice 136 up ureter 105 , and into kidney 110 . A pusher (not shown) is then moved along guide wire 710 , pushing stent 120 along guide wire 710 towards kidney 110 . Proximal end 144 of elongated member 140 can be positioned either at or distal to ureteral orifice 136 . Stent 120 can also be positioned such that proximal retention structure 135 is at or distal to ureteral orifice 136 . Once the surgeon has achieved the desired positioning of stent 120 , guide wire 710 is removed, while holding the pusher stationary to maintain stent 120 in position. Finally, the pusher is removed from within the patient, leaving stent 120 in place. Using this method, the stent of the invention can be precisely positioned within ureter 105 of the patient. The method can also be used to accurately position proximal retention structure 135 in bladder 115 , and distal retention structure 125 within kidney 110 . In one embodiment of the invention, the guide wire, pusher, and stent are inserted into ureter 105 percutaneously through a surgical opening. In another embodiment, they are inserted into the ureter via the urinary tract of the patient. While the invention has been particularly shown and described with reference to specific preferred embodiments, it should be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit of and priority to U.S. Provisional Patent Application Ser. No. 60/489,845 entitled “Novel Anesthetic Delivery Device” by David Hodgson, filed Jul. 24, 2003, the entire contents of which are specifically incorporated herein by reference for all it discloses and teaches. BACKGROUND OF THE INVENTION [0002] Exotic wild animals and fractious, aggressive pets are often presented in cages for treatment by veterinarians. Handling these animals in a manner that is both safe to the veterinarian and humane for the animal may be impossible without anesthesia. It is important to minimize struggling and excessive fright to the animal since prolonged excitation can disturb the circulatory and metabolic state of the animal and induce a degree of shock. However, attempts to anesthetize a struggling wild animal or fractious pet presents safety problems in addition to enhancing the likelihood of an abnormal response. These points are particularly pertinent to the restraint and anesthesia of wild animals. [0003] By definition tranquilizers produce psychological calming of anxiety without physiological depression or clouding of consciousness. However, when tranquilizers are used to produce manageability, high doses are usually necessary which may result in ataxia, variable response to stimulation and cardiorespiratory depression. Cardiovascular depression may be severe and, if followed by a general anesthetic, the combination may lead to severe hypotension. [0004] Tranquilizers do not exert hypnotic or analgesic affects. Increasing the dose does not produce greater sedation, even though the psychological depressant affects are magnified. [0005] The psychological state of the animal prior to administration of tranquilizers may markedly affect the degree of sedation achieved. Animals that are vicious, intractable and in a state of excitation may not become manageable, except with very high (incapacitating) doses, therefore it is often preferred to treat these animals with an anesthetic instead of tranquilizers. [0006] Dissociative anesthetics produce a state of chemical restraint and anesthesia characterized by a form of muscle rigidity and an apparent dissociation of the mind from the external environment. The eyes remain open; various reflexes, including the blinking reflex remain intact. Adequate respiration is normally maintained, an increase in heart rate and blood pressure frequently occurs. While the widest use of dissociative anesthetic agents is probably with primates and felines, they have also been used in most other mammalian species as well as birds and reptiles. [0007] Currently, these dissociative anesthetics and tranquilizers are administered via a dart delivered from a blowgun or syringe pole. Problems associated with darts are numerous. The dart must enter muscle tissue and fully discharge to deliver the calculated dose of drugs. Occasionally darts miss the animal entirely or do not discharge the drug into muscle tissue. Inadvertent movement of the animal may allow the dart to hit the animal's eye or other organ that may produce damage and harm. With injectable drugs it is difficult to estimate the amount of drug to use. An overdose may produce death and an under dose may produce more agitation and excitement. Some animals, especially primates that have been darted in the past are very apprehensive when they know that they are to be darted again. The time from darting to restraint of the patient is very unpredictable. Darting devices used by unskilled operators can produce more damage than benefits. [0008] Inhalant anesthetics delivered in sufficient quantity over a short period of time give a relatively rapid onset and rapid recovery after the inhalation anesthetic is discontinued. They can be administered with a high degree of controllability over anesthetic depth and duration through the manipulation of drug dose, rate of vaporization, and cessation of administration when the desired effect is produced on the animal. To date, however, specialized, expensive vaporizers and oxygen equipment has been required to use inhalant anesthetics. These devices are very expensive and delivery of anesthetic to large cages and chambers is very prolonged before effects on the animal are seen. [0009] Monitoring the dosage of inhalant anesthetic is important. Differences in anesthetic solubility determine the speed with which gas concentration builds up in the arterial blood. As highly soluble gases require more time to build up a significant concentration in the blood, they result in a more prolonged induction and recovery. The reverse is true of the highly insoluble gases which are therefore more controllable as their blood concentration can be rapidly changed; however, for this reason they are more hazardous and require quantitative methods to govern their delivery in safe concentrations. [0010] Currently, inhalant anesthetics can be administered by means of a simple nose cone for the performance of short procedures or via a mask or endotrachial tube connected to a vaporizer. Numerous apparati have been devised for these purposes, but none of these can be effectively used to treat the excited or vicious animal before removing it from its cage. The current way to deliver anesthetics to cages is to flow oxygen through an expensive precision vaporizer. This method consumes large volumes of oxygen and volatile liquid anesthetics. For animals in large chambers, a prolonged period of time is necessary to induce an anesthetic state. This method is not adaptable to use in the field except with a lot of heavy, complex, and expensive equipment. [0011] Accordingly, what is needed in the art is a simple, inexpensive, transportable device and method to safely anesthetize wild or otherwise vicious animals while they are in their transport cages. BRIEF SUMMARY OF THE INVENTION [0012] The present invention solves the prior art problems mentioned above and provides a distinct advance in the state of the art. In particular, through the present invention, apparatus and methods are provided which allow the application of inhalation anesthesia to wild animals or fractious domestic pets before they are removed from their transport cages. The apparatus and method are easy to use, relatively inexpensive to produce, transportable to the field, safe and effective. [0013] The present invention may therefore comprise an apparatus for use in anesthetizing animals in cages comprising: a metal tube having a tube wall and a plurality of holes formed in the tube wall in a spaced apart relationship around the metal tube and along a distal portion of the metal tube; a wick disposed in the metal tube, the wick made of fibrous material that is adapted to absorb liquid anesthetic; an end cap disposed in the distal end of the metal tube, the end cap having an opening for delivering liquid anesthesia, using a needle, through the end cap to the wick; a flexible tube connected to a proximal end of the metal tube that is capable of delivering air to and from the metal tube; an air pump that pumps air into and evacuates air from the metal tube by actuation of a pump handle to cause vaporization of the liquid anesthesia on the wick. [0014] The present invention may further comprise a method of administering anesthesia to animals in a cage using a vapor wand comprising: injecting liquid anesthetic through an end cap in the vapor wand using a needle that is adapted to fit in an opening in the end cap so as to deliver the liquid anesthetic to a fibrous wick, the vapor wand having a metal tube with the end cap attached to a distal end of the metal tube, the metal tube having a plurality of holes disposed along a distal portion of the metal tube, the fibrous wick disposed in the metal tube so as to absorb the liquid anesthesia injected through the end cap; attaching a proximal end of the metal tube to a plastic tube; attaching the plastic tube to an air pump; activating the air pump to cause air to flow through the metal tube and vaporize the liquid anesthetic so that vaporized liquid anesthetic is discharged from the vapor wand through the holes. [0015] Embodiments of the invention offer several advantages over the current art. For example, the apparatus is appropriate for field, clinic or hospital use thus giving it wide applicability. No electricity or compressed gases or oxygen is needed to power the device. It is therefore, a unique apparatus and method for delivering inhalant anesthetics in the field. The apparatus is easy to operate, inexpensive and can be produced in several sizes to accommodate a wide variety of clinical and research applications. The method is easy to understand and implement while producing controllable and reliable results. In addition, the volume of anesthetic used is much smaller than that used when flowing gas through a calibrated vaporizer resulting in additional cost savings. BRIEF DESCRIPTION OF THE DRAWINGS [0016] FIG. 1 is a pictorial view of the vapor wand apparatus, shown with the parts broken away to illustrate assembly of the pieces. [0017] FIG. 2 is a graph illustrating the method for determining the amount of anesthetic to use to achieve the desired concentration as determined by cage volume for cage volumes ranging from zero to 16,000 cubic inches. [0018] FIG. 3 is a graph illustrating the method for determining the amount of anesthetic to use to achieve the desired concentration as determined by cage volume for cage volumes ranging from zero to 2,500 cubic inches. DETAILED DESCRIPTION OF THE INVENTION [0019] The following examples set forth various embodiments of the present invention. It is to be understood, however, that these examples are provided by way of illustration and should not be taken as limiting the overall scope of the invention. [heading-0020] Materials and Methods [0021] A vapor wand was constructed of 1.9 cm OD copper tube 10 which is 75 cm in length with multiple 0.6 cm holes 12 in the distal 20 cm portion of the tube. A distal end-cap with hole 14 is fitted to introduce liquid isoflurane (ISO) via a hypodermic syringe into a full-length cotton wick 32 . The proximal end is fitted with a 0.6 cm hose barb 22 and a female leur fitting 24 to allow additional ISO administration. [0022] The vapor wand 10 is constructed of a metallic (stainless steel, brass, or copper) tube 10 with multiple holes 12 in the distal end. A distal end-cap 14 with injection hole is fitted to introduce inhalant anesthetics in the liquid form into the vapor wand via a hypodermic syringe (not shown) into a full-length fibrous wick 32 that may be made of cotton. The proximal end is fitted with a hose barb 22 and female leur fitting 24 to allow additional anesthetic administration. The air pump 16 , or other recirculation device, is connected to the hose barb 22 via flexible tubing 26 . [0023] The apparatus can be constructed in a variety of sizes to accommodate different cage sizes. The appropriate size of the apparatus is determined by the amount of anesthetic that is initially loaded onto the cotton wick 32 in order to achieve the desired target anesthetic concentration. For small volumes a smaller wand with a shorter wick can be used. Similarly, for cages with large volumes, a larger wand with longer wick can be used. [0024] Embodiments of the present invention allow a desired amount of anesthesia to be delivered to caged animals in order to temporarily immobilize the animal, while adequate respiration and heart rate are maintained so that the animal can be safely and humanely removed from the cage for subsequent treatment. Formulas have been developed, depending on cage volume, to produce a target anesthetic concentration that is shown in FIGS. 2 and 3 . [0025] Upon presentation of the animal in a cage, the cage is measured and the volume of the cage is calculated. The cage is then enclosed in a heavy, close fitting plastic bag. After injecting the desired volume of anesthetic into the wick 32 of the vapor wand, the distal end of the vapor wand is introduced through a small hole cut into the plastic bag. The opening of the bag is sealed around a transparent window to facilitate ongoing observation of the animal. The proximal end of the vapor wand remains outside of the cage. A gas tight air pump 16 , or other circulating device, is then attached to the hose barb 22 and is pumped using air pump handle 30 to cycle cage gas back and forth through the vapor wand to enhance vaporization of the liquid anesthetic in the wick 32 . The more frequent the cycling of the syringe, the faster the liquid is vaporized and the faster the animal becomes anesthetized. [0026] The device illustrated in FIG. 1 was used to anesthetize different species and sizes of animals, including domestic cats, dogs and mandrills (small baboon). Cage volumes ranged from 28 to 275 liters (1708 to 16780 cubic inches). Liquid volume of isoflurane (ISO) was calculated to produce a target concentration of five percent if complete vaporization occurred. The speed of induction time varied directly with cage volume. Induction times ranged from 2.07 to 7.5 minutes. At completion of induction of anesthesia and immobilization, the bag was rapidly opened and a mask was fitted on the patient's nose and attached to an anesthetic circuit to maintain anesthesia. [0027] FIG. 2 is a graph 200 illustrating the liquid isoflurane requirements for anesthetic induction of animals in enclosed cages. The graph shows the percentage of isoflurane vapor plotted for cage volumes from 0 to over 240 liters versus the amount of isoflurane in milliliters. [0028] FIG. 3 is a graph 300 illustrating the liquid isoflurane requirements for anesthetic induction of animals in enclosed cages. The graph shows the percentage of isoflurane vapor plotted for cage volumes varying from 0 to 40 liters versus the amount of isoflurane in milliliters. EXAMPLE 1 [0029] This example pertains to a Ferel cat presented by a police department animal control officer. The cage containing the cat measured 12″×12″×21″ with a volume 3024 cubic inches. The target concentration of isoflurane vapor equaled five percent. The cage was placed inside a plastic bag and was then sealed around a small transparent window. The vapor wand was loaded with 12.4 ml isoflurane liquid and inserted through a small hole that was cut into the bag. The air pump was manually pumped to cycle cage gas back and forth through the vapor wand to enhance vaporization of the liquid anesthetic in the wick. [0030] Results [0031] Induction time to complete anesthesia was two minutes and three seconds. The induction was very smooth, with no adverse movements or responses. EXAMPLE 2 [0032] A Mandrill (small baboon) was presented in a cage which measured 22″×32″×24″ with a volume of 16,896 cubic inches. The target concentration of isoflurane vapor equaled five percent. The cage was placed inside a plastic bag and was then sealed around a small transparent window. The vapor wand was loaded with 76 ml isoflurane liquid and inserted through a small hole that was cut into the bag. The air pump was manually pumped to cycle cage gas back and forth through the vapor wand to enhance vaporization of the liquid anesthetic in the wick. [0033] Results [0034] Induction time to complete immobility and a moderate plane of anesthesia was six minutes and eighteen seconds. The induction was very smooth. The animal was quiet with no struggling. CONCLUSION [0035] As described above, the vapor wand can be used to safely and effectively anesthetize a variety of aggressive animals while they are in their cages. It should be understood that the implementation shown is illustrative and should not be considered as limiting in any way the scope of the invention. For example, the apparatus and method can be used to anesthetize animals other than those shown. The apparatus can be constructed in varying sizes to accommodate both large and small cages, the size of the apparatus being dependent on the amount of liquid anesthetic required to achieve the target anesthetic concentration. Thus, the apparatus and method of use of the apparatus are advancements over the current art, providing an inexpensive, reliable, portable device for anesthetizing animals presented in cages for treatment. [0036] The foregoing description of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and other modifications and variations may be possible in light of the above teachings. The embodiment was 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 in various embodiments and various modifications as are suited to the particular use contemplated. It is intended that the appended claims be construed to include other alternative embodiments of the invention except insofar as limited by the prior art.

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CROSS-REFERENCES TO RELATED APPLICATIONS This application claims the benefit of Provisional Application Ser. No. 61/429,683, filed Jan. 4, 2011, the contents of which are incorporated by reference. BACKGROUND OF THE INVENTION The present disclosure is directed towards devices and methods for stimulating nerves. In one application, an approach for more effectively treating post-surgical symptoms is contemplated. A common side effect of surgery is nausea and vomiting caused by a reaction to the general anesthetic. In fact, nausea, vomiting, and retching after surgical procedures not only cause patient discomfort, but can also prolong time to discharge from ambulatory surgery centers and results in unanticipated hospital admissions. A wide variety of prophylactic antiemetics, including antihistamines (e.g., hydroxyzine, promethazine), butyrophenones (e.g., droperidol), and gastrokinetic agents (e.g., metoclopramide), have been successfully used to reduce the incidence of postoperative nausea and vomiting (PONV). However, many of these antiemetics are associated with undesirable side effects. According to an article by Tang et al. (The Effect of Timing of Ondansetron Administration on Its Efficacy, Cost-Effectiveness, and Cost-Benefit as a Prophylactic Antiemetic in the Ambulatory Setting; 1998 International Anesthesia Research Society), however, Ondansetron is effective for both the prevention and treatment of PONV without producing significant side effects. The manufacturer recommends that ondansetron be administered before induction of anesthesia when used as a prophylaxis. The recommendation is based on the hypothesis that blockade of receptors in the chemoreceptor trigger zone before the arrival of emetic stimuli associated with anesthesia and surgery provides greater antiemetic efficacy. The Tang et al. study concluded that ondansetron administered immediately before the end of surgery was the most efficacious in preventing postoperative nausea and vomiting, facilitating both early and late recovery. Acupuncture is an ancient medical art dating back many centuries. Traditionally, points in the human body were reached by piercing the body with fine wires or needles. The needles were then rotated or manipulated about their longitudinal axes, for example by rubbing an exposed end of a needle between a thumb and finger, to stimulate the acupuncture points. Stimulation of specific acupuncture points has been shown in several studies to have an impact in treating conditions such as nausea and vomiting, postoperative pain, headache, smoking cessation, erectile dysfunction, depression, male fertility, dysmenorrhea, and stomach acid secretion and urinary urgency. At the National Institutes of Health Consensus Conference on Acupuncture in 1997, the efficacy of acupuncture was shown in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain, and that there were other situations, such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma. Acupuncture was identified as being useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. There is a recognized acupuncture point just below the crease of the inside of the wrist that has also been associated with the relief of nausea. This is one location of the median nerve whose stimulation is generally credited with producing this relief of symptoms and has been referred to as the P6 acupuncture point. In recent years, it has been observed that electrical stimulation of this location has produced the same effect (Anesthesiology 2007 December; 107(6): 903-8). Peripheral nerve stimulators have become to be commonly used during surgery to monitor the effects of medications deployed for monitoring of neuromuscular relaxation. These devices are hand held appliances that provide a broad range of current, stimulation frequency and pattern settings. However, they tend to be costly and also lack the portability needed to attach to a patient's wrist without causing significant inconvenience. Not all peripheral nerve stimulators have the capability of continuous stimulation and many have tetanus buttons that if deployed on an awake patient would cause significant pain. These traditional nerve stimulators are not designed for continuous P6 accustimulation. Electrical stimulation of the P6 acupuncture point, in particular, has been found to reduce the incidence of postoperative nausea and vomiting (PONV). According to the Amberger et al. study (Monitoring of Neuromuscular Blockade at the P6 Acupuncture Point Reduces the Incidence of Postoperative Nausea and Vomiting; Anesthesiology, V. 107, No. 6, December 2007) antiemetic drugs generally can reduce, but they do not eliminate postoperative nausea and vomiting (PONV). Acupuncture and its different approaches, such as needle acupuncture, electroacupuncture, and acupressure, are well described in nausea treatment. This approach is non-pharmacologic and offers the same independent efficacy as does ondansetron according to the Amberger study. As stated, the P6 or Neiguan acupuncture point is located just proximal to the distal skin crease of the wrist, or more specifically in the anterior antebrachial region on the ulnar side of the tendon of the flexor carpi radialis. It was found that stimulation of the P6 acupuncture point in adult women undergoing gynecologic laparoscopic surgery showed a marked reduction of PONV incidence. That is, transcutaneous electrical stimulation of the P6 acupuncture point reduced nausea. Thus, Amberger et al. concluded that intraoperative P6 acupuncture point stimulation with a conventional nerve stimulator during surgery significantly reduced the incidence of PONV over 24 hours. The efficacy of P6 stimulation is similar to that of commonly used antiemetic drugs in the prevention of PONV. It is possible that using both pharmacologic and non-pharmacologic modalities may be synergistic. Various approaches to electrostimulization in general have been considered. In one approach, there is provided a disc shaped device that has two primary layers. A first layer for adhering to a patient's skin surface and a second layer on the underside of which electrical circuitry is printed or affixed so that the electrical circuitry is sandwiched between the layers. Single use and reusable devices have further been contemplated. In the reusable device a pressure-sensitive adhesive material forms the lower layer which allows for multiple applications to a patient's skin. In either configuration, metal core insulated leads can be used for electrical connection with the opposite ends of the leads connected to jacks for connection to an impulse stimulator or can end in electrically conductive tabs. In another approach, an electro-acupuncture device including a hydrogel for enhancing electrical conduction between the device and the skin and to provide an impedance matching layer between the device and the skin is contemplated. The hydrogel masses are sized and dimensioned so that when the pad is adapted to the device, the hydrogel masses do not bridge the electrodes to cause a short between the electrodes. Other related devices not indicated for addressing nausea have also been described. One such approach involves an electrode-battery assembly for a miniature wireless transcutaneous electrical neuro or muscular stimulation unit capable of being removably attached. The assembly is generally comprised of two sided electrodes, batteries, various conductive transmission materials and a mechanical means for securing the conductive materials to the batteries. In addition, the assembly can be rechargeable or be disposable. In another approach, a disposable electric bandage for electrical stimulation including a device for delivery of electric current. The device will increase circulation, generating motor and sensory stimulation and peripheral nerve stimulation. The device further includes circular electrodes and a circular power source, such as a battery. The electrodes are coated with hydrogel, which readily facilitates providing a moist surface and in addition a conductive interface means between the patch and body area of a subject. It is noted that a conductive interface may also be a conductive adhesive. Further, yet another approach involves a self-contained electronic musculoskeletal stimulation apparatus that is a battery-operated device. The device applies electronic stimulation to a human with a stimulation protocol to introduce pain relieving electronic stimulation to the body for immediate, symptomatic relief of minor, chronic and acute musculoskeletal aches and pains and mild muscle tension. A patient attaches the apparatus onto the body with electrogel pads, which function as an adhesive to hold the apparatus in place. When the treatment button is depressed, one of the indicators will blink rapidly to indicate which intensity is currently being used to treat the patient and provide the patient with the identification of the intensity being used by the patient and an indication of treatment beginning. Prior work has indicated, however, that existing devices are providing stimulation wave forms that are largely effective but still fail to relieve nausea and vomiting in approximately 3-5% of patients. Protocols associated with the use of the nerve stimulators have also been found lacking. Accordingly, there is need to develop a compact version of an acustimulization device that can attach comfortably to the body (i.e., wrist) so that it can be worn home and then disposed. Protocols describing the use of the device with medication are needed. The present application addresses these and other needs. In particular, Perioperative nausea and vomiting, nausea associated with chemotherapy, nausea associated with pregnancy and nausea associated with motion. The application may be used alone or as part of a treatment regime to address nausea. SUMMARY Briefly and in general terms, the present disclosure is directed toward a self contained and powered unit having numerous applications both inside and outside of medicine. In one approach, the unit embodies a compact electrokinetic nerve stimulator that is designed specifically to treat post operative nausea and vomiting with enhanced effectiveness. The disclosed device can also stimulate other nerves such as the anterior tibial nerve for the purpose of treating urinary urgency. Methods relating to the use of the stimulator are also disclosed. In one particular aspect, the nerve stimulator is embodied in a disposable patch that is attachable to a patient's body. The patch can be sized and shaped to be placed on an exterior of a patient's skin to stimulate the median nerve. The device can include two electrodes, a microchip, a pulse generator assembly, and a power cell encapsulated by a film cover. One variation of the device contemplates a scopolamine patch attached to the device, but outside the electrical field to address both pharmacologic and nonpharmicologic modalities in a single applied device. Wireless transmission of vital signs including oxygenation and heart rate, such as through blue tooth integration is contemplated as is RF integration to transmit identification data. A method of transmitting location data through wireless transmission or RF integration or the like is also contemplated. In one treatment modality the nerve stimulator device is activated at the beginning of surgery and permitted to operate for up to seventy-six or more hours or to the end of the battery life. A dose of ondansetron is given intravenously twenty minutes prior to the end of surgery. In a rescue modality, general evaluation of the patient is made with history and appropriate exam, hydration status is optimized. The application of the nerve stimulator device is contemplated. A rapid acting agent with or without a longer acting agent is given intravenously. A particular approach can involve the administration of intravenous propofol and intravenous promethazine along with the use of the nerve stimulator device. Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plane view, depicting a compact electrokinetic nerve stimulator; FIG. 2A is a bottom view, depicting a schematic representative of an electrokinetic nerve stimulator; FIG. 2B is a cross-sectional view, depicting the electrokinetic nerve stimulator of FIG. 2A ; FIG. 2C is another cross-sectional side view, depicting the electrokinetic nerve stimulator of FIG. 2A ; and FIG. 3 is a perspective view, depicting a nerve stimulator attached to a patient. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, which are provided by way of example and not limitation, there is shown a compact electrokinetic stimulator. Stimulation of the median nerve at the ventral portion of the wrist is well documented for the prevention of postoperative nausea and vomiting. Existing nerve stimulators that are employed in operating rooms to stimulate the median nerve at this location can be lacking. The problems with such apparatus are lack of uniformity among nerve stimulators, bulk of the equipment, lack of portability and disposability and cost of the equipment. Accordingly, the present disclosure is offered as a solution to problems that hinder wider application of nerve stimulation. One application of the nerve stimulator of the present disclosure is to the anterior tibial nerve to treat urinary urgency. Other applications are also contemplated. Moreover, application of a disposable stimulator on the median nerve can facilitate the prevention of nausea in various settings such as postoperative, chemotherapy, pregnancy as well as other etiologies not otherwise specified. One contemplated location to access the median nerve is at the ventral wrist. The disposable nature of the device allows the device to travel with the patient thus preventing reactivation of the chemoreceptors trigger zone which may prevent nausea that occurs after discharge from the recovery room. It should be noted that the described treatment aids in the alleviation of the symptoms of nausea but does not treat the underlying etiology. In addition to use of the device in a preemptive protocol, the nerve stimulator may be used to treat persons experiencing postoperative nausea and vomiting or nausea from other etiologies with a rescue protocol, and may be used to stimulate nerves other than the median nerve as well. Oscilloscopic analysis was conducted on a circuit that was being applied to the median nerve region while it was being stimulated with a 1.5 to 5 mA current. The alternating pulse and ramp functions applied by the stimulator were of low enough voltage to consider it feasible to use small battery technology as an alternative power supply. A microchip is contemplated to be sufficient to run the algorithms required to provide nerve stimulation that regulates the current to approximate a target value of 1.5 to 5 mA with a frequency of 2 Hz. As shown in FIGS. 1-3 , the nerve stimulization device 100 of the present disclosure includes a flexible plastic tape or cover 102 with two adhesive EKG style electrode assemblies 104 . The nerve stimulator can act as a acustimulator device. The device can be relatively small being approximately 1.5 inches wide and about 3 inches long. A microchip and miniature circuit board 106 can be mounted between the two electrodes 104 as shown in the figures. Activation of the device 100 can be accomplished by pulling or removing a pull tab (not shown) that would complete the circuit with the power cells. A LED light 108 can be configured to flash when a current is detected. Alternatively, a magnetic wand (not shown) can be employed to start the circuit and set it to operate for either 8 or 16 hours (with a second touch of the wand, or to the end of battery life). A pulse generator powered by a battery 109 and controlled by the microchip 106 can deliver 1.5 to 5 milliamperes of current at 2 Hz. The battery 109 and microchip 106 cooperate to form a pulse generator assembly. Furthermore, this assembly can be configured to detect impedance of skin to insure that the desired amperage is delivered. As best seen in FIGS. 2B and 2C , a top portion 112 of the stimulator device 100 can be formed of a foam material. A bottom portion of the device is contemplated to embody a foam insulation. Wires 116 extend from the pulse generator assembly to each electrode assembly 104 . Further, an energy transmitting gel 120 is associated with each electrode assembly 104 to facilitate a desired contact with the patient. An adhesive 130 can also be incorporated into the bottom surface of the device 100 for attachment to the target location on the patient's body. Extended operation of up to 76 hours is also contemplated. Thus, a battery is chosen to provide up to or more than 76 hours of operation. Prior to assembly, the microchip 106 can be “stamped” with a control algorithm that is housed and delivered by a dedicated laptop computer. The device 100 can be evaluated using a circuit load that simulates the impedance of the median nerve region 200 . This evaluation can record the applied current and voltage wave forms and the frequency of application. Multiple rounds of evaluation can be conducted to verify circuit performance. Use of various wave forms may provide enhanced effectiveness. One aspect is the long term use of the device following surgery. Most conventional peripheral stimulation does not last 10-20 hours. Accordingly, one contemplated approach is employing a balanced waveform that avoids the net buildup of ions (polarization). Other waveforms are contemplated to specifically avoid side effects. Yet another waveform issue for long term stimulation is the speed with which the peak current is applied to the patient. Thus, a waveform characterized by a gentle slope to this build up is also contemplated. In one embodiment, it is contemplated that the wave form that will be employed can be characterized as a box wave form at a 5 mA current and a frequency of 2 Hz. Use of the device alone provides an estimate fifty percent reduction in postoperative nausea and vomiting. In conjunction with a single prophylactic dose of intravenous ondansetron 4 mg on emergence should offer results superior to either intervention alone. The patient continues to use the device for up to 76 hours or to end of battery life. Elements of a rescue protocol include hydration and administration of fast acting agents capable of breaking the nausea and vomiting cycle with application of the acustimulator. In the postoperative care setting with the patient being monitored, administration of 10 mg of intravenous propofol and 6.25 to 25 mg of intravenous promethazine is performed along with the application of the acustimulator. In one treatment protocol, a first step involves an assessment of the patient. A patient history is taken and a physical is performed. It is recognized that nausea and vomiting risk stratification is multifactored and a patient's condition must be assessed in order to arrive at the first preventative treatment. Thus, a patient's entire health and treatment history is reviewed and key aspects are noted and weighed. Additionally, the type of procedure that the patient is about to undergo is also assessed and analyzed as is the anesthesia that will be used in the procedure. For example, it is noted whether a pelvic region or an intrabdominal procedure is to be conducted. Also surgical patients can be stratificated as to low, medium and high risk. It is to be recognized that for low risk procedures, for example minor skin procedures or radiologic procedures, an anesthetic technique that minimizes nausea such as a Total IntraVenous Anesthetic (TIVA) technique using propofol is contemplated. Moderate risk procedures such as those applicable in distal extremity orthopedic procedures would utilize the disclosed stimulation device along with a TIVA and an additional antiemetic such as Ondansetron. High risk procedures such as those associated with intra-abdominal or pelvic surgery would utilize the stimulation device, TIVA and two or more additional antiemeitics such as ondansetron and dexamethasone. Separate specific considerations can be important where the patient is undergoing emetogenic chemotherapy. It is noted that some chemotherapeutic agents are much more emetogenic than others. As well, dosage and timing frequency and inter-patient variables can impact the probability and severity of nausea. Thus, the routine antiemetic therapy should be given and the stimulation device should be placed and activated, just before infusion of chemotherapy begins. Moreover, distinct protocols may be necessary when treating nausea and vomiting associated with pregnancy and labor. Such patients may require a different approach due to limitations of systemic antiemetics used during pregnancy. Median nerve acustimulation is nonpharmacologic therefore avoids potential risk associated with systemic pharmacologic agents. Treating patients suffering from motion sickness can involve other considerations. For example, it may be necessary to consider Over-the-Counter availability of motion sickness or nausea medications. Thus, a protocol combining the stimulation device with available OTC antiemetics such as Dimenhydrinate can lead to a successful treatment. In general, the treatment of nausea, is intended to be multimodal in nature. Thus, the application of nerve stimulation in conjunction with the administration of an antiemetic is contemplated. For a low risk patient in a method for treating nausea, the stimulization device 100 is attached to the patient at a ventral portion of the wrist above the median nerve. The device 100 is activated ideally within 60 minutes and with the patient in a supine or semi-recombinant position prior to induction of anesthesia. The device 100 is permitted to operate until depletion of the battery. In treating a medium risk patient for nausea, the acustimulator device 100 is applied to the ventral portion of the wrist above the median nerve for example, and is activated within 60 minutes prior to the induction of the anesthesia. Again, here, the device 100 is permitted to operate until the depletion of the battery. In addition, 30 minutes prior to the emergence of anesthesia, 4 mg of Ondansetron is administered to the patient intravenously. For a high risk patient, the acustimulator device 100 is applied as before and 4 mg of Ondansetron is administered. Additionally, 4 to 8 mg of dexamethasone is administered to the patient intravenously after the induction of anesthesia. The patient is also assessed to determine whether a scopolamine patch and/or an oral dose of aprepitant 40 mg should be given to the patient prior to induction of anesthesia. Moreover, in the perioperative period, there are other considerations. These include maintenance of normovolemia by administration of intravenous fluids, and minimizing IV or oral opiates as these medications commonly cause nausea and regional anesthesia when appropriate. For example, utilizing peripheral nerve blocks for orthopedic procedures on the upper and lower extremities or epidural blocks for thoracic, abdominal, pelvic or lower extremity procedures can be appropriate in a treatment scheme. Where a patient is undergoing chemotherapy, one approach to nausea treatment would be to apply the acustimulator device 100 to stimulate the median nerve 30 to 60 minutes prior to the infusion of emetogenic chemotherapy along with standard current anti-emetics. The device 100 would then be employed continuously until battery depletion. It is also contemplated that the acustimulator device 100 can be equipped to receive replacement batteries. In this way, continued treatment for the prevention of nausea can be performed such as that might be necessary during pregnancy. The device 100 would be applied to stimulate the median nerve at early signs of pregnancy induced nausea, for example, and allowed to work until battery depletion. A new battery can then be inserted into the device 100 when new signs of nausea begin to appear after a last round of treatment. It is further contemplated that a transdermal antiemetic such as scopolamine can be contained within the adhesive portion of the stimulation device. The antiemetic can be placed inside or outside the field of stimulation energy. In one application the drug can be delivered utilizing ionophoretic technology for transdermal delivery of anti-emetic agent(s). Other transdermal delivery technologies are contemplated. The approach of combining median nerve accustimulation and a transdermal anti-emetic in a single contained disposable unit as multimodal therapy is contemplated. Accordingly, the present disclosure is intended to address postoperative symptoms such as nausea. Thus, it will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without parting from the spirit and scope of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application Ser. No. 60/831,953, filed on Jul. 20, 2006, titled “SEMI AUTOMATIC DISPOSABLE TORQUE LIMITING DEVICE AND METHOD,” the disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention generally relates to a torque limiting device and method. More particularly, the present invention pertains to a device and method for limiting an amount of torque applied by the device using a disposable insert. BACKGROUND OF THE INVENTION [0003] In various manufacturing, construction, and medical industries, objects or fasteners are utilized that are positioned, threaded or screwed into place. These objects or fasteners may include a predetermined amount of torque that has been determined to be optimal for a given fastening or positioning situation. In addition, the fastener or object may include a predetermined amount of torque that has been determined to fatigue or break the fastener or object. Often, these predetermined torque values are determined by the manufacturer or by a testing facility. In use, a technician or user may employ a device such as a torque wrench to set the fastener or object according to the predetermined amount of torque. In a particular example, bone screws may be employed by surgeons to reconstruct bones or attach replacement components to bones of patients. In such circumstances, applying a proper amount of torque may be critically important. [0004] Conventional torque wrenches utilize forces from coil springs and spring washers along with friction to limit the amount of torque applied. Unfortunately, as components within these conventional torque wrenches slide by one another, wear may alter the torque setting of the conventional torque wrench. As such, conventional torque wrenches need to be re-calibrated to maintain their torque limit range. [0005] Conventional torque wrenches require lubricants for the proper operation of the mechanism. These lubricants break down during steam-sterilization and can oxidize components which may reduce the accuracy of the device. In addition, these conventional torque wrenches require re-lubrication during cleaning or re-calibration cycles. [0006] Conventional torque wrench mechanisms may also fail and bind or lock-up thereby eliminating the torque-limiting effect and essentially converting the tool to a rigid, non-limiting tool with torque limiting now regulated to the tool users ability to discern torque forces by hand. This could lead to over-torquing, an unsafe condition. [0007] Accordingly, it is desirable to provide a device and method capable of overcoming the disadvantages described herein at least to some extent. SUMMARY OF THE INVENTION [0008] The foregoing needs are met, to a great extent, by the present invention, wherein in one respect a device and method of limiting an amount of torque applied is provided. [0009] An embodiment of the present invention pertains to a torque limiting apparatus. The torque limiting apparatus includes a head, handle, head axial bore, and handle axial bore. The head includes a central rotational axis. The handle is rotatably fastened to the head. The handle and head mate at an interface. The head axial bore is defined by the head and is offset from the central rotational axis. The handle axial bore is defined by the handle and offset from the central rotational axis. The handle axial bore is shaped to receive a torque limiting insert. In response to the head being at a first rotational position relative to the handle, the head axial bore and handle axial bore are disposed in cooperative alignment to allow the torque limiting insert to transect the interface and enter the head axial bore. The head and the handle are rotationally coupled via the torque limiting insert. The head and the handle are rotationally uncoupled in response to a shear force being applied across the interface that exceeds a shear limit for the torque limiting insert. [0010] Another embodiment of the present invention relates to an apparatus for applying a predetermined amount of torque to a fastener. The apparatus includes a head means, handle means, and torque limiting means. The head means transmits torque to the fastener. The handle means is coupled to the head means for applying an amount of torque to the fastener. The torque limiting means is interoperably disposed between the head means and the handle means to limit an applied torque from being transmitted from the handle means to the head means by shearing a torque limiting insert in response to the amount of torque being greater than the predetermined amount of torque. The handle means is rotationally decoupled from the fastener in response to the torque limiting insert being sheared. [0011] Yet another embodiment of the present invention pertains to a method of applying a predetermined amount of torque upon a fastener. In this method, a torque limiting device is coupled to the fastener. The torque limiting device includes a torque limiting insert. In addition, an amount of torque is applied upon the fastener by urging a handle of the torque limiting device to rotate. The torque limiting insert is subjected to a shear force in response to the amount of torque. The torque limiting insert is sheared in response to the amount of torque being greater than the predetermined amount of torque. The handle is rotationally decoupled from the fastener in response to the torque limiting insert being sheared. [0012] There has thus been outlined, rather broadly, certain embodiments of the invention in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional embodiments of the invention that will be described below and which will form the subject matter of the claims appended hereto. [0013] In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting. [0014] As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a perspective view of the torque limiting device according to an embodiment of the invention. [0016] FIG. 2 is an exploded view of the torque limiting device of FIG. 1 . [0017] FIG. 3A is a side view of a disposable insert suitable for use with the torque limiting device of FIG. 1 . [0018] FIG. 3B is a side view of the disposable insert following a calibration procedure. [0019] FIG. 3C is an exploded view illustrating insertion of the disposable insert into the torque limiting device of FIG. 1 . [0020] FIG. 4A is a top view of the torque limiting device in a loaded position. [0021] FIG. 4B is a cross-sectional view A-A of the torque limiting device in the loaded position. [0022] FIG. 5A is a top view of the torque limiting device in a shear position. [0023] FIG. 5B is a cross-sectional view B-B of the torque limiting device in the shear position. [0024] FIG. 5C is an end view of the torque limiting device in the shear position. [0025] FIG. 5D is a cross-sectional view C-C of the torque limiting device in the shear position. [0026] FIG. 6A is a top view of the torque limiting device in an eject position. [0027] FIG. 6B is a cross-sectional view D-D of the torque limiting device in the eject position. [0028] FIG. 6C is an end view of the torque limiting device in the eject position. [0029] FIG. 6D is a cross-sectional view E-E of the torque limiting device in the eject position. [0030] FIG. 7A is a top view of the torque limiting device in a second loaded position. [0031] FIG. 7B is a cross-sectional view F-F of the torque limiting device in the second loaded position. [0032] FIG. 8A is a top view of the torque limiting device in a second shear position. [0033] FIG. 8B is a cross-sectional view G-G of the torque limiting device in the second shear position. [0034] FIG. 8C is an end view of the torque limiting device in the second shear position. [0035] FIG. 8D is a cross-sectional view H-H of the torque limiting device in the second shear position. [0036] FIG. 9A is a top view of the torque limiting device in a second eject position. [0037] FIG. 9B is a cross-sectional view I-I of the torque limiting device in the second eject position. [0038] FIG. 9C is an end view of the torque limiting device in the second eject position. [0039] FIG. 9D is a cross-sectional view J-J of the torque limiting device in the second eject position. [0040] FIG. 10A is a cross-sectional view of the torque limiting device in a final eject position. [0041] FIG. 10B is a cross-sectional view of the torque limiting device in the final eject position. [0042] FIG. 10C is a cross-sectional view of the torque limiting device in the final eject position according to another embodiment. [0043] FIG. 11 is an exploded view illustrating removal of the used insert from the torque limiting device of FIG. 1 . [0044] FIG. 12 is a flow diagram illustrating a method of installing a fastener according to an embodiment of the invention. DETAILED DESCRIPTION [0045] The present invention provides a semi automatic torque limiting device and method. In one example of a preferred embodiment, the torque limiting device includes a disposable, torque limiting, insert. The disposable insert includes a predetermined number of segments. During use, a segment of the insert is sheared off in response to a predetermined amount of torque being applied to a handle of the torque limiting device. The sheared segment may be stored in the handle. [0046] In various embodiments, the torque limiting device may include any suitable material, such as, plastic, polymer, resin, metal, or the like. In a preferred example, the torque limiting device includes materials that may be sterilized for use in an operating theater. For example, autoclaveable polymers and corrosion resistant-type metals may be utilized to fabricated the torque limiting device and/or the insert. The insert may include a rod or bar with a number of annular grooves that correspond to the number of segments. Material characteristics of the insert and the cross sectional area at the groove may be utilized to determine a torque value for the torque limiting device. [0047] It is an advantage of embodiments of the invention that the torque limiting device substantially and/or continually maintains a pre-set torque limit that is governed by the insert. It is another advantage that this pre-set torque limit is essentially unaffected by frictional wear. As such, the need for testing and recalibration of the torque limiting device may be eliminated. [0048] Preferred embodiments of the invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. As shown in FIG. 1 , a torque limiting device 10 may be utilized to install a fastener 12 in a substrate 14 . The torque limiting device 10 includes a handle 16 for the user, technician, or surgeon to grasp. The torque limiting device 10 further includes a shaft 18 connecting the handle 16 to a head 20 . The head 20 is configured to engage the fastener 12 . In various embodiments, the head 20 and shaft 18 may be essentially a single component or the head 20 may be releasably attached to the shaft 18 to facilitate exchanging the head 20 with another head 20 . [0049] In general, the torque limiting device 10 is configured such that in response to turning the handle 16 about an axis A (as shown in FIG. 1 ), an applied torque will urge the shaft 18 to rotate in a similar fashion. The torque limiting device 10 is configured such that at a threshold or max torque, the shaft 18 ceases to rotate about the axis A in response to rotating the handle 16 about the axis A. In conventional devices, the limit at this threshold torque is affected by frictional forces of one member sliding against another. Unfortunately, this friction results in mechanical wear that may alter the characteristics of the torque applied through the device. It is an advantage of various embodiments that friction is a substantially negligible component of the applied torque. As such, the embodiments are essentially unaffected by frictional or mechanical wear. [0050] In addition, while not explicitly shown in FIG. 1 , the torque limiting device 10 may include a display to display the amount of torque being applied to the fastener 12 . Furthermore, the torque limiting device 10 may include a ratcheting mechanism to provide unidirectional or selectable unidirectional rotation of the shaft 18 . This is an optional feature so that the operator does not have to change or reset the hand position on the tool. [0051] FIG. 2 is an exploded view of the torque limiting device of FIG. 1 . On a driver-end of the device 10 there is the shear component 22 . On the proximal end of the shear component 22 there are two holes: a center hole 24 and a shearing hole 26 A. The center hole 24 receives a shoulder screw 28 that connects the rotating handle 16 to the driver-end 18 . The shearing hole 26 A carries a spring-loaded ejector pin 30 and a spring 32 whose travel is limited by the mating of an axial slot 34 in the ejector pin 30 and a limit pin 36 . [0052] The handle 16 includes a plurality of holes or bores that may be selectively aligned with the shearing hole 26 A. For example, as shown in FIG. 2 , the handle 16 includes an insert loading bore 26 B and a segment collecting bore 26 C. The insert loading bore 26 B may further include a bushing 26 BB to facilitate shearing the torque limiting insert 40 . [0053] In addition, the torque limiting device 10 includes one or more torque limiting disposable inserts or inserts 40 , springs 42 to advance the inserts 40 and a cap 44 to retain the inserts 40 and a spring assembly 46 . [0054] FIG. 3A is a side view of the disposable insert 40 suitable for use with the torque limiting device 10 . The inserts may be made from any suitable material. Suitable materials include plastic or polymers, metals, and the like. In a particular example, the inserts include a segmented plastic length of material. As shown in FIG. 3A , the insert 40 includes segments 50 A to 50 n that are delineated by annular grooves 52 A to 52 n . The annular grooves 52 A to 52 n serve to concentrate shear stress between adjacent segments 50 A to 50 n . In this manner, the annular grooves 52 A to 52 n facilitate a clean and/or repeatable shearing action. Because the shearing hole 26 A is rotationally offset from the central axis A, torque applied to the handle 16 generates a corresponding force at the shearing hole 26 A and a shearing force upon the torque limiting insert 40 . In particular, the depth of the shearing hole 26 A and length of the segments 50 A to 50 n are matched such that the shearing force is exerted, each in its turn, upon the annular grooves 52 A to 52 n . The cross sectional area and material characteristics of the torque limiting insert 40 at the annular grooves 52 A to 52 n is configure to shear in response to a predetermined amount of shear force. The amount of shear force each of the annular grooves 52 A to 52 n can absorb before being sheared or severed is a “shear limit.” The shear limit is defined as the amount of shear stress or strain sufficient to result in the partial or complete fracture or breaking of the torque limiting insert 40 . One or more of the segments 52 A- 52 n may be sheared in the torque limiting device 10 or reasonable facsimile thereof to test or calibrate the insert 40 . The insert 40 further includes a base or flanged insert portion such as a flange 54 shown in FIG. 3A . [0055] In various embodiments, the shear limit of the torque limiting insert 40 may include any suitable value. For example, various standard fasteners may have a manufacturer's recommended installation torque of less than 1 Newton Meter (Nm) to greater than 10 Nm. Accordingly, the torque limiting insert 40 may include a shear limit of 1 Nm, 2 Nm, 4 Nm, 6 Nm, and the like. To differentiate the torque limiting insert 40 having one shear limit from another torque limiting insert 40 having another shear limit, the torque limiting insert 40 may include an indicator value, differentiating color, size, shape, or the like. In a particular example, the torque limiting insert 40 may include a particular shape for each shear limit. That is, while the torque limiting insert 40 shown in FIG. 3A is depicted as generally cylindrical, the torque limiting insert 40 having a different shear limit may be, for example, an elongated 3 , 4 , or multi-sided prism. According to an embodiment, the insert loading hole 26 B and/or bushing 26 BB may be configured to accept only a certain shaped torque limiting insert 40 . [0056] FIG. 3B is a side view of the disposable insert following a calibration procedure. Once the testing or calibration is performed a “working” length segmented insert 40 is left with three torque-limiting segments 50 C to 50 n remaining. However, in other embodiments, more or less than three segments 50 A- 50 n may be retained. [0057] FIG. 3C is an exploded view illustrating insertion of the disposable insert 40 into the torque limiting device 10 . Loading the torque limiting device 10 is simple and a thrust bearing 56 , for example, may be included on the backside of the spring assembly 46 to reduce assembly friction. [0058] FIG. 4A is a top view of the torque limiting device 10 in a loaded position. The handle 16 is rotated to a “Load” position. At this point an insert 40 will be aligned with the eject pin 30 . [0059] FIG. 4B is a cross-sectional view A-A of the torque limiting device 10 in the loaded position. In the transparent view above, the loaded positions are shown. The handle 16 is turned till one of the insert 40 , hereafter referred to as the “first insert 40 ,” is loaded into the hole 26 in the shear component 22 . There are springs 42 and 32 behind the first insert 40 and the ejector pin 30 . The larger spring 42 behind the first insert 40 has a higher spring rate than the ejector pin spring 32 , thus over-powering the ejector spring 32 and the first insert 40 advances the ejector pin 30 until its movement is limited by the pin-slot combination. When the first insert 40 is fully advanced to the stop the insert 40 is correctly positioned for the “torque-limiting” step. [0060] FIG. 5A is a top view of the torque limiting device 10 in a shear position. When the first insert 40 shears at the pre-determined torque value, the handle 16 will rotate relative to the shear component 22 to an in-between position between “Load” and “Eject”. [0061] FIG. 5B is a cross-sectional view B-B of the torque limiting device 10 in the shear position. In the above view the front segment 50 C of the first insert 40 is shown sheared and retained inside the shearing hole 26 A of the shear component 22 . Because there is only the one shearing hole 26 A on the shear component 22 that is on the same bolt circle as the first insert 40 , the first insert 40 will not advance to the next position until the shearing hole 26 A is emptied. [0062] FIG. 5C is an end view of the torque limiting device in the shear position. As shown in FIG. 5C , the section line C-C is disposed at an angle to pass through the loading bores 26 B. [0063] FIG. 5D is a cross-sectional view C-C of the torque limiting device 10 in the shear position. As shown in FIG. 5D , the cross-sectional view C-C transects the loading bore 26 B and illustrates how both the first insert 40 and a second insert 40 are essentially prevented from advancing while the shear component 22 is positioned between “Load” and “Eject” position. [0064] FIG. 6A is a top view of the torque limiting device 10 in an eject position. As shown in FIG. 6A , the handle 16 is rotated into an “Eject” position. [0065] FIG. 6B is a cross-sectional view C-C of the torque limiting device 10 in the eject position. As shown in the cross-sectional view, the segment 50 C of the first insert 40 that has been sheared off will now advance into ejection chamber of the handle 16 . Because of the limit slot in the ejector pin 30 it will not advance into the ejection chamber. A cleaning port or clearing port 58 is optionally included to augment ejection. For example, if included, a wire or pin may be inserted to augment the action of the spring 32 . [0066] FIG. 6C is an end view of the torque limiting device 10 in the eject position. As shown in FIG. 6C , the section line E-E is disposed at an angle to pass through the loading bores 26 B. [0067] FIG. 6D is a cross-sectional view E-E of the torque limiting device 10 in the eject position. As shown in FIG. 6D , the cross-sectional view E-E transects the loading bore 26 B and illustrates how both the first insert 40 and second insert 40 are essentially prevented from advancing while the shear component 22 is in the eject position. [0068] FIG. 7A is a top view of the torque limiting device 10 in a second loaded position. The handle 16 is now rotated to the next “Load” position. [0069] FIG. 7B is a cross-sectional view F-F of the torque limiting device 10 in the second loaded position. As can be seen in the cross-sectional view, the first segment 50 C of a second insert 40 advances into the shear component 22 , pushing the ejector pin 30 until it stops. Note that the first segment 50 C will not advance until it aligns with the hole 26 A in the shear component 22 . [0070] FIG. 8A is a top view of the torque limiting device 10 in a second shear position. When the second insert 40 shears at the pre-determined torque value, the handle 16 will be in an in-between position of “Load” and “Eject”. [0071] FIG. 8B is a cross-sectional view G-G of the torque limiting device 10 in the second shear position. In the above view the front segment 50 C of the second insert 40 is shown sheared and retained inside the hole 26 A of the shear component 22 . Because there is only the one hole on the shear component 22 that is on the same bolt circle as the second insert 40 , the second insert 40 will not advance to the next position. [0072] FIG. 8C is an end view of the torque limiting device 10 in the eject position. As shown in FIG. 8C , the section line H-H is disposed at an angle to pass through the loading bores 26 B. [0073] FIG. 8D is a cross-sectional view H-H of the torque limiting device 10 in the eject position. As shown in FIG. 8D , the cross-sectional view H-H transects the loading bore 26 B and illustrates how both the first insert 40 and second insert 40 are essentially prevented from advancing while the shear component 22 is between the load eject positions. [0074] FIG. 9A is a top view of the torque limiting device 10 in a second eject position. In response to rotating the handle 16 the torque limiting device 10 advances to an “Eject” position. [0075] FIG. 9B is a cross-sectional view I-I of the torque limiting device 10 in the second eject position. As shown in the transparent view above, the segment 50 C of the second insert 40 that has been sheared off will now advance into ejection chamber of the handle 16 . Because of the limit slot 34 in the ejector pin 30 it will not advance into the ejection chamber. Note that there are now two separate insert 40 (e.g., the first and second insert 40 ) segments in two separate ejection chambers. [0076] FIG. 9C is an end view of the torque limiting device 10 in the second eject position. As shown in FIG. 9C , the section line J-J is disposed at an angle to pass through the loading bores 26 B. [0077] FIG. 9D is a cross-sectional view J-J of the torque limiting device 10 in the second eject position. As shown in FIG. 9D , the cross-sectional view J-J transects the loading bore 26 B and illustrates how both the first insert 40 and second insert 40 are essentially prevented from advancing while the shear component 22 is in the eject position. [0078] FIG. 10A is a cross-sectional view of the torque limiting device 10 in a final eject position. As shown in FIG. 10A , the segments 50 C- 50 E are retained within the collecting bores 26 C [0079] FIG. 10B is a cross-sectional top view of the torque limiting device 10 in the final eject position. As shown in FIG. 10B , the flange 54 is configured to engage a lip or otherwise essentially prevent the insert 40 from progressing further than the final segment. [0080] FIG. 10C is a cross-sectional top view of the torque limiting device 10 in the final eject position according to another embodiment. As you can see from the cross-sectional views above, the torque limiting device 10 according to this particular embodiment is capable of six torque-limiting uses. In other embodiments, the torque limiting device 10 and/or the insert 40 may be configured for more or fewer torque-limiting uses. Once the segments 50 C- 50 n are all sheared off the flange 54 will prevent the insert 40 from advancing further. At this point the device 10 will only spin. The device 10 is also designed to hold all six segments 50 A- 50 n. [0081] FIG. 11 is an exploded view illustrating removal of the used insert 40 from the torque limiting device 10 of FIG. 1 . [0082] FIG. 12 is a flow diagram illustrating a method 60 of installing a fastener according to an embodiment of the invention. As shown in FIG. 12 , the method 60 may be initiated at step 62 in response to installing a torque limiting insert such as the insert 40 in the torque limiting device 10 . To initiate installation, loading sleeves or bores may be accessed. For example, the retaining cap 44 may be unscrewed or otherwise removed along with the spring 42 and spring assembly 46 to expose the loading bore 26 B and the collecting bore 26 C. Thereafter, the insert 40 may be positioned in the loading bore 26 B and the torque limiting device reassembled. Of note, the insert 40 installed in the torque limiting device 10 may be selected based upon a predetermined torque limit for a particular fastener that is to be installed. For example, a fastener such as a bone screw may have a recommended installation torque of 4 Newton Meters (Nm). The insert 40 selected for installation may include a predetermined shear strength that corresponds to 4 Nm of torque. [0083] At step 64 , the fastener 12 may be installed in the substrate 14 . For example, a bone screw may be screwed into the bone of a patient. More particularly, the fastener 12 may be coupled to the torque limiting device 10 by a bit and the handle 16 may be rotated until the insert 40 is sheared as shown in FIGS. 5A and 5B . [0084] At step 66 , a severed segment may be ejected from the head 20 . For example, as shown in FIGS. 6A and 6B , the shearing hole 26 A may be aligned with the collecting bore 26 C. In response, the segment 50 C, for example, may be urged by the spring loaded ejector pin 30 and spring 32 into the collecting bore 26 C. [0085] At step 68 , it may be determined if additional fasteners are to be installed. For example, if an ongoing operational procedure indicates addition fasteners may be utilized, it may be determined if the additional fasteners include essentially the same torque indication at step 70 . If no additional fastener installation is indicated, the torque limiting device 10 may be cleaned at step 78 . [0086] At step 70 , it may be determined if essentially the same torque limit is indicated. For example, essentially the same torque limit may be indicated in situations utilizing the same type of bone screw being installed into similar boney tissue. If it is determined that essentially the same torque limit is indicated, it may be determined if additional segments 50 C- 50 n remain attached to the insert 40 . If it is determined that a different torque limit is indicated, the insert 40 may be exchanged at step 74 . [0087] At step 72 , it may be determined if more segments remain. For example, if upon rotating the handle 16 relative to the head 20 one full rotation, no segment 50 C- 50 n is loaded into the shearing hole 26 A, then it may be determined that no segments remain and the insert 40 may be replaced at step 74 . If segments 50 C- 50 n do remain, a next segment may be loaded if not already done so at step 76 . [0088] At step 74 , the insert 40 may be replaced. For example, the retaining cap 44 may be unscrewed or otherwise removed along with the spring 42 and spring assembly 46 to expose the loading bore 26 B and the collecting bore 26 C. As shown in FIG. 11 , the insert 40 and any spent segments 50 C- 50 n may be removed via the assistance of gravity by tilting the torque limiting 10 . Thereafter, the insert 40 having a torque limit corresponding to a next fastener to be installed in the loading bore 26 B as shown in FIG. 3C and the torque limiting device reassembled. [0089] At step 76 , a next segment 50 C- 50 n may be loaded. For example, if a segment has not already been loaded, the head 20 may be rotated relative to the handle 16 until the load position is obtained as shown in FIGS. 7A and 7B . Following loading, a fastener may be installed at step 64 . [0090] At step 78 , the torque limiting device 10 may be cleaned. For example, the torque limiting device 10 may be disassembled as shown in FIG. 11 and the torque limiting device 10 may be washed. Once emptied of inserts 40 , the torque limiting device may be reassembled and/or sterilized. In a particular example, the torque limiting device 10 may be autoclaved. [0091] The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application relates to U.S. patent application Ser. No. 09/865,127, entitled SPA AUDIO SYSTEM OPERABLE WITH A REMOTE CONTROL, filed on the same date hereof, and now U.S. Pat. No. 6,516,070 granted Feb. 4, 2003. A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of 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 1. Field of the Invention The present invention relates to an apparatus for remotely controlling other systems or apparatus and further being adapted for receiving feedback signals indicative of the state of the controlled apparatus. 2. Description of Related Art Most remote controls, such as those we use today for our home entertainment devices use an infrared beam for communication. Some use sounds above our audible range. In any event, these prior art remote devices are one way only. That is, they will transmit a command signal to a device but are not adapted to receive a response, such as a device status signal. Therefore, a need exists for a remote control that can not only transmit commands to a controlled slave unit, but can also receive feedback status signals from the slave unit. Moreover, there is a need for a radio frequency (“RF”) remote control device that can communicate between walls or windows. SUMMARY OF THE INVENTION These and other objects, which will become apparent as the invention is described in detail below, wherein a spa system includes a remote control for controlling operation thereof. The system includes a remote control module having a microprocessor and memory therefor, which is receptive to push-button inputs. The remote control has a display and an antenna for transmitting signals to the spa and for receiving signals back from the spa. A master control module resides within the spa for controlling and sensing a multiplicity of functions of the spa. A slave control module is coupled to the master control module and also has an antenna responsive to command signals received from the remote control, and for transmitting status signals back to the remote control. The slave control module is used for converting the command signals received from the remote control for the master control, and for converting status signals received from the master control for transmission back to the remote control. An object of the present invention is to provide a remote control for a spa that can receive a return signal indicative of the status of a given function of the spa. Another object of the present invention is to provide feedback from the spa that indicates such things as water temperature, power-on, status of jets and whether or not a water-jet pump is on. Still another object of this invention is to provide a remote control that can sense the present temperature and set a desired temperature. Yet another object of this invention is to provide a remote control that is simple to use by employing only 3-button controls—1 button for mode and 2 buttons for ON or OFF/increase or decrease of the selected mode. Still other objects, features and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein is shown and described only the preferred embodiment of the invention, simply by way of illustration of the best mode contemplated of carrying out the invention. As will be realized, the invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive, and what is intended to be protected by Letters Patent is set forth in the appended claims. The present invention will become apparent when taken in conjunction with the following description and attached drawings, wherein like characters indicate like parts, and which drawings form a part of this application. BRIEF DESCRIPTION OF THE DRAWINGS The general purpose of this invention, as well as a preferred mode of use, its objects and advantages will best be understood by reference to the following detailed description of an illustrative embodiment with reference to the accompanying drawings in which like reference numerals designate like parts throughout the figures thereof, and wherein: FIG. 1 illustrates the remote control in accordance with a specific embodiment of the present invention; FIG. 2 is a more detailed diagram of the display of the remote control of the present invention; FIGS. 3A–3E illustrate a variety of data displays for the remote control shown in FIGS. 1 and 2 ; FIG. 4 is a block diagram of the electronic structure of the remote control; FIGS. 5A and 5B combined form a block diagram of the system including the master control; and FIGS. 6A and 6B combined form a flow chart illustrating the process for operation of the remote control of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventor of carrying out his invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the general principles of the present invention have been defined herein specifically to provide an improved RF remote control apparatus for controlling other systems or apparatus. Referring now to the drawings and FIG. 1 in particular, a remote control 10 is illustrated. RF signals from the remote control 10 are low power, but adequate to reach an antenna 17 within a spa 16 . The power is preferably low to avoid interference with a neighbor's radio or television reception. The remote control 10 also receives status signals back from the spa regarding the status of such things as water temperature, and the like as will be explained in greater detail hereafter. The remote control 10 includes a display 11 having icons displayed thereon, which represent various functions to be amplified hereinafter. The remote control 10 also includes a mode button 12 for changing the function of the remote from one mode to another; and, a switch 13 having a pair of buttons marked +/− (“ON/OFF” or “increase/decrease”) for use in conjunction with the mode button 12 for changing or setting a function. The remote control 10 is preferably powered by three AAA batters, is preferably waterproof and is preferably capable of floating in water. According to a specific embodiment of the present invention, the remote control 10 operates under the control of a master or main control 15 located within a spa 16 . The main control 15 receives signals from the remote control 10 via an antenna 17 , and transmits information to the remote control by the same antenna 17 . Referring now to FIG. 2 , the display 11 of the remote control 10 is shown in greater detail. The display 11 includes numerous icons, which indicate the status of various functions of the spa 16 . A Ready Light icon 20 will illuminate when the temperature of the water in the spa 16 is within 2 degrees of the selected temperature. A Power Light icon 21 will illuminate when the spa system is turned on and power is connected. An Alpha/Numeric display array 22 is disposed for indicating numerous functions selected by the mode switch 12 , or for displaying information received back from the master control 15 . For example, when the temperature mode is selected by pressing the mode button 12 ( FIG. 1 ), a Temp Light icon 23 illuminates and the temperature of the water 23 A is indicated by the display array 22 . When a temperature set mode is selected by the mode button, a Set icon 24 will illuminate. As the +/− switch 13 or buttons 13 are pressed, the temperature is moved up or down as selected and is shown by the display array 22 . As the remote control 10 communicates with the master control 15 , a Comm icon 25 will flash, which indicates communication is taking place between the two units. Additional functions indicated by the display 11 on the remote control 10 include a Water Care icon 26 , which when illuminated indicates that the sanitary system of the spa 16 is operating normally or not. A Light icon 27 will illuminate when the mode switch 12 selects the spa light function. In the spa light mode, depressing the + button of the switch 13 will turn the spa light 27 on, and depressing the − button of the switch 13 will turn the spa light off. In a similar fashion, when the mode switch 12 has selected the jets mode, a Jets icon 28 illuminates and the jets of the spa can be turned on and off using the buttons of Switch 13 . A SpAudio icon 29 illuminates when the mode switch 12 is stepped to this function. When the + button of the switch 13 is depressed, the SpAudio turns on. In a similar manner, when the − button of the switch 13 is depressed, the SpAudio turns off. The SpAudio feature is explained in greater detail in the U.S. patent application Ser. No. 09/865,127, entitled SPA AUDIO SYSTEM OPERABLE WITH A REMOTE CONTROL, filed May 24, 2001, now U.S. Pat. No. 6,516,070, and assigned to the assignee hereof. A Summer Timer light icon 30 illuminates when the mode switch 12 is stepped to this function, and when the + of switch 13 is depressed, this function is turned on. In a similar manner, when the − button of this switch 13 is depressed, this function is turned off. The Summer Timer function is useful in a warm climate. For example, in a place like Arizona in the summer time the ambient temperature may be quite high. A feature of the spa 16 is to continuously circulate the water by the heater to maintain a set temperature. In a warm climate, when using the water circulate feature, the water temperature may rise above a desired setting. Accordingly, by turning on the Summer Timer function, the water is not circulated continuously. This helps to maintain the pre-set desired temperature. Another function indicated by the display 11 is a Lock icon 31 . The Lock function can do two things. First, the entire spa system can be locked so that no one can make changes to the settings—unless they have the remote control. Secondly, the temperature setting can be locked to a pre-selected setting while the other functions are not locked. Referring now to FIGS. 3A through 3E , a variety of displays that may be shown by the display 11 of the remote control 10 are illustrated. FIG. 3A shows a set temperature display. Note that the Ready and Power icons 20 and 21 , respectively, are illuminated, as well as the Set and Temp icons, 24 and 23 , respectively; and, the temperature setting of 103° F. is shown. FIG. 3B shows the display when the remote control 10 is set in the Light mode. Note that the word LIGHT 22 B appears across the display array 22 , while the Light icon 27 is illuminated. FIG. 3C shows the spa 16 is clean when in the Water Care mode, wherein icon 26 is illuminated and the word CLEAN 22 C appears across the display array 22 . FIG. 3D shows the display when the status of the spa has a low PH, or high acidity. Note that the Water Care icon 26 is illuminated and the term LO PH 22 D appears across the display array 22 . FIG. 3E shows the display when the remote is in the Jet setting mode. Note that the Jets icon 28 is lit and the term JETS2 22 E appears across the display array 22 . The term JETS2 refers to the water-jet pump number 2 . Referring now to FIG. 4 , the electronics of the remote control 10 are illustrated. The center of the remote control 10 is a Microprocessor Unit (“MPU”) 35 . The MPU 35 has coupled thereto a RAM 36 and a ROM 37 , which are conventional peripherals to a microprocessor and will not be described further herein. Also, the MPU 35 is powered by a battery 38 , which in a specific embodiment includes three AAA batteries. A battery recharge circuit 39 and a battery monitor 40 are coupled between the battery 38 and the MPU 35 , which are also well known in the art and will not be amplified further herein. A watchdog circuit 41 is also coupled to the MPU 35 to make sure the commands are being executed properly and to reset internal program functions. Pushbutton inputs 42 are coupled to input terminals of the MPU 35 to receive signals from the mode button 12 or the +/− selection switch 13 . Display Driver 43 is coupled to outputs of the MPU 35 in a conventional manner, which in turn drive the display 11 described hereinabove. The display 11 also includes a back light 44 made up of Light Emitting Diodes (“LED”). An Internal Monitor 45 is coupled to the MPU for the purpose of determining any MPU non-conforming operation. RF signals are transmitted from the remote control 10 or received from the main control 15 by means of a transceiver 46 and an antenna 47 . The operation of the remote control 10 will be more fully appreciated hereinafter with the description accompanying FIGS. 6A and 6B . At this juncture, reference is made to FIGS. 5A and 5B for a block diagram of the system including the master control 18 which with RF module 60 is the Main Control 15 . A number of sensing devices are coupled to the master control 18 , such as a Temp Sensor 50 , which senses the spa water temperature. Spa Lights 52 are controlled by the master control 15 as are Jets 51 and Heater 53 . A Current Sense 54 senses the current in the water heater and jet pumps and provides appropriate inputs indicative thereof to the master control 18 . A water circulating pump 55 and a color wheel 56 are likewise controlled by the master controller 18 . The term color wheel refers to an apparatus for changing the color of the light in the spa, but not necessarily by an actual color wheel. A remote control panel 57 for the spa 16 also provides inputs to the master control 18 . An ozone sensor 58 provides inputs to the master control 15 through an IIC (Inter Integrated Circuit) bus 59 , which is adapted for the IIC protocol. The IIC protocol is well known in the art and will not be amplified further herein. Referring now to FIG. 5B , the IIC bus 59 is coupled to an RF interface module 60 , which performs an RF to IIC slave control. The RF interface module 60 includes a UART (Universal Asynchronous Receiver/Transmitter), which is an integrated circuit used for serial communications, containing a transmitter (parallel-to-serial converter) and a receiver (serial-to-parallel converter), each clocked separately. UART's are well known in the industry and will not be discussed further herein. The remote control 10 , described hereinabove, is adapted to communicate with the master controller 18 by means of the UART. Also coupled to the IIC bus 59 are such devices as a Water Treatment 61 and a SpAudio 62 , which is disclosed in greater detail in U.S. patent application Ser. No. 09/865,127, entitled SPA AUDIO SYSTEM OPERABLE WITH A REMOTE CONTROL, filed May 24, 2001, now U.S. Pat. No. 6,516,070, and assigned to the assignee hereof. An IR module 63 is also coupled to the IIC bus 59 . This module is used for servicing the spa. An infrared (“IR”) link couples a remote control 63 . The remote 64 , may, for example, comprise a PalmPilot device used by service technicians. PalmPilot is a product available from Palm, Inc. of Santa Clara, Calif. 95052. A separate control panel 65 for the spa 16 may likewise be coupled to the IIC bus 59 . Referring now to FIG. 6A , a flow chart of the operation of the remote control 10 is illustrated. The process begins with an initialization of the MPU 35 (bubble 100 ) followed by the turning on of the LED back-light 44 (block 101 ). After this, a 15-second timer is reset (block 102 ) and a query is made (block 103 ) for a default LCD from the RF interface module 60 . Next, the remote control 10 is placed in normal receive mode (block 104 ) which is illustrated in FIG. 6B and amplified hereinafter. After this, an inquiry is made as to whether or not a key was pressed on the remote control 10 (diamond 105 ). If the answer to this inquiry is yes, then the 15-second timer is reset (block 106 ) and this key value is sent to the RF interface module 60 (block 107 ). Next, the LCD from the RF interface module is queried (block 108 ) and the remote control 10 is again placed in the normal receive mode (block 104 ). If a key was not pressed, then another inquiry is made as to whether or not the 15-second timer has expired (diamond 109 ). If the answer to this inquiry is no, then the remote control is placed in the normal receive mode (block 104 ). On the other hand, if the answer to this inquiry is yes, then the back-light is turned off (block 110 ) and the 2-minute timer is reset (block 111 ). Next, the default LCD from the RF interface module 60 is queried (block 112 ) and the remote control 10 enters into a sleep mode with a wake up every 18 milliseconds (block 113 ). After this, an inquiry is made as to whether or not the 2-minute timer has expired, and if yes it is reset (connector B returns back to the block 111 ). If the 2-minute timer has not expired, then yet another inquiry is made as to whether or not the 30-minute timer has expired (diamond 115 ). If the answer to this inquiry is no, then still another inquiry is made as to whether or not a key was pressed (diamond 116 ). If the answer to this inquiry is no, then the remote control enters the sleep mode with a wake up every 18 milliseconds (block 113 ). On the other hand, if the answer to this inquiry is yes, then a return is made back to the block 102 to reset the 15-second timer (via the connector A). If the 30-minute timer has expired (diamond 115 ) then the remote control goes off line (bubble 117 ). Referring now to FIG. 6B , a flow chart of the NRM process (Normal Receive Mode) is shown. The process begins with a start bubble 120 followed by an inquiry as to whether or not data was received (diamond 121 ). If the answer to this inquiry is yes, then Entry is set equal to zero (ENTRY=0, bubble 122 ). ENTRY counts the number of communication attempts between the remote and the RF module. Next, the request is sent to the RF interface module 60 (block 123 ) and the 100 millisecond timer is started (block 124 ). After this, the RF remote listens to the RF interface module 60 ( FIG. 5B ) (block 125 ) for data to determine what should be displayed. An inquiry is then made as to whether or not valid data was received (diamond 126 ). If the answer to this inquiry is yes, then the data is displayed (block 127 ) and the process ends (bubble 128 ). Note that if no data was requested (diamond 121 ), then the NRM process ends. If the data received was not valid, then another inquiry is made as to whether or not the 100 millisecond timer has expired (diamond 129 ). If the answer to this inquiry is no, then a return is made back to the block 125 . On the other hand, if the 100 millisecond timer has expired then yet another inquiry is made as to whether or not Entry is greater than 2 (diamond 130 ). This is done for the purpose of making sure that the remote and the RF interface module 60 have communicated correctly. If ENTRY is not greater than 2, then ENTRY is incremented and a return is made back to the block 123 for sending the request back to the RF interface module 60 . On the other hand, if Entry is greater than 2, then the display is cleared (block 132 ) and the NRM process ends (bubble 128 ). The methods and apparatus of the present invention, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMS, hard drives, or any other machine-readable storage medium, wherein, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the invention. The methods and apparatus of the present invention may also be embodied in the form of program code that is transmitted over some transmission medium, such as over electrical wiring or cabling, through fiber optics, or via any other form of transmission, wherein, when the program code is received and loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the invention. When implemented on a general-purpose processor, the program code combines with the processor to provide a unique apparatus that operates analogously to specific logic circuits. While the invention has been particularly shown and described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. Those skilled in the art will appreciate that various adaptations and modifications of the just-described preferred embodiments can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the priority date benefit of Provisional Patent Application Ser. No. 60/669,165, filed Dec. 8, 2005. FEDERALLY SPONSORED RESEARCH [0002] Not applicable. SEQUENCE LISTING, ETC ON CD [0003] Not applicable. BACKGROUND OF THE INVENTION [0004] 1. Field of the Invention [0005] This invention relates to an infant bed and, more particularly, to an infant bed that is adapted for co-sleeping by the infant in an adult bed. [0006] 2. Description of Related Art [0007] It is well known that newborn human infants require a great deal of sleep. The most common sleeping place for newborns and small infants during the first few months of life is in a bassinet. Then, as the infant grows and becomes too large for the bassinet, it is typically moved to a crib. Most newborn infants are unable to raise their heads for a number of days or weeks after birth, and most are unable to roll themselves over for several weeks or months. Because of the limited mobility of most newborns, the bassinet where they sleep is typically provided with a firm and flat mattress pad and no pillow in order to help prevent inadvertent suffocation of the infant. A tall peripheral wall around the bassinet prevents the infant from falling out. Unfortunately, these features make the bassinet bulky and difficult to transport. [0008] It is typical for the adult parents of newborn infants to keep the bassinet in the adult bedroom at night. This facilitates easy access to the infant during the night for feeding, changing or other needs that the infant may have. However, the unpredictable and seemingly unceasing demands of newborn infants can take their toll on the new parents and deprive them of much needed night sleep. Often, the warm and soothing touch of the parents is all that is necessary to help the infant fall asleep. Unfortunately, it can be both awkward and uncomfortable to lean over or reach into the bassinet in order to comfort the infant, especially when the tired parent would much rather be lying down. It is therefore desirable to provide an infant bed that can be easily accessed by the parent while lying down. [0009] This arrangement, termed “co-sleeping”, involves the use of an infant bed that is adapted to support and protect an infant when sleeping in the adult bed. This arrangement may be not only desired, but required, by mothers who are recovering from labor and delivery, and/or from Caesarian section births. Likewise, nursing babies may be fed at night with minimal disruption of the sleep of the nursing mother. [0010] One exemplary design is described in U.S. Pat. No. 6,370,715, issued to Farah Morton on Apr. 16, 2002. It is directed toward a portable infant bed having a base panel, and an end wall and two side walls surrounding contiguous edges of the base panel to protect the infant from hazards such as choking, suffocating, or rollover injuries. The present invention is viewed as providing significant improvements over that patented invention. BRIEF SUMMARY OF THE INVENTION [0011] The present invention generally comprises an infant bed construction that protects an infant when sleeping in the same bed as the parent or other adult. The infant bed is comprised of a frame that includes a head end wall, two side walls, and a base panel. These elements may be formed integrally as a molded plastic coffer that is provided with reinforced edges and rigid rib sections molded into the panel elements. Alternatively, these elements may be separate components that are secured in a fabric cover that is provided with pockets to removably secure the panel portions, and straps to retain the assembly in the erected configuration in which the infant is protected by objects falling into the infant bed. [0012] A salient aspect of the infant bed is the provision of a safety bar assembly to protect the area where the head of the infant will be resting. In general terms, the safety bar assembly includes an arched or bowed structure that spans the side walls adjacent to the head end wall, and has opposed ends that are secured to the side walls. In one embodiment, the safety bar includes a central tubular portion and a pair of parallel legs at opposed ends of the central portion. A pair of mounting brackets are secured to opposed side wall portions of the bed, and the legs of the safety bar are secured to the mounting brackets. The brackets are formed with a keyway entry that receives a complementary key formed at the end of each safety bar leg. The brackets also include interior arcuate tracks in which a respective key may pivot. As a result, the legs of the safety bar may be releasably joined to the mounting brackets, and the safety bar may be pivoted from a generally vertical placement over the head of the infant, to a forward position that is adjacent to the head end wall of the infant bed. Thus the safety bar may be positioned above the head of the infant resting in the infant bed, thereby to protect the infant from pillows, bed clothing, and the like that may otherwise fall onto the face or head of the infant and pose a potential choking/suffocating hazard. [0013] The safety bar key/keyway mounting arrangement is oriented so that the safety bar will pull out of the mounting brackets if the safety bar is pulled upwardly in a generally vertical direction. As a result, the construction of the infant bed prevents using the safety bar as a handle for lifting the infant bed. Moreover, the mounting brackets are positioned closer to the head end of the bed, so that the center of gravity of the bed is displaced from the pivot axis of the safety bar. Thus the safety bar is clearly designed not to be used as a carrying handle. [0014] However, a spring ball detent mechanism in each mounting bracket holds the safety bar at one or more predetermined angular orientations in snap-release fashion. One such angular orientation is the central portion of the safety bar directly above the head area of the infant and the legs disposed generally vertically, thus providing maximum resistance to pillows, bedclothes, and the like that may otherwise fall onto the head or face of the infant. The safety bar assembly may also be provided with a night light disposed in the central tubular portion. With the central tubular portion disposed above the infant, the night light is actuatable to illuminate the face of the infant at rest in the infant bed. BRIEF DESCRIPTION OF THE DRAWING [0015] FIG. 1 is a perspective view of one embodiment of the frame structure of the infant bed of the present invention, shown with the safety bar in the erect disposition. [0016] FIG. 2 is a perspective view of one embodiment of the frame structure of the infant bed as in FIG. 1 , shown with the safety bar pivoted to the forward position. [0017] FIG. 3 is an enlarged partial cross-sectional view taken along line 3 - 3 of FIG. 1 . [0018] FIG. 4 is a perspective view of the frame structure of in the infant bed similar to that shown in FIGS. 1-3 , with the safety bar in exploded view and a fabric cover assembly enclosing the frame structure and defining a foot end wall. [0019] FIG. 5 is a perspective view of an alternative embodiment of the frame structure of the infant bed, in which the side panel components are separable from the frame and joined thereto by a fabric cover assembly. [0020] FIG. 6 is an exploded, perspective view of the safety bar mounting engagement. [0021] FIG. 7 is an enlarged cross-sectional view taken along line 7 - 7 of FIG. 4 . [0022] FIG. 8 is a perspective view of a further embodiment of the frame structure of the infant bed in which the side walls include removable panel portions. [0023] FIG. 9 is an exploded perspective view of the frame embodiment of FIG. 8 , showing the removable panel portions separated from the frame assembly. [0024] FIG. 10 is a perspective view of a further embodiment of the frame structure of the infant bed in which the side walls include removable hinged extension portions. [0025] FIG. 11 is an exploded perspective view of the frame embodiment of FIG. 10 , showing the removable panel portions separated from the frame assembly. [0026] FIG. 12 is an enlarged perspective view of a representative hinge assembly of the embodiment of FIGS. 10 and 11 . [0027] FIG. 13 is a perspective view of another embodiment of the frame of the infant bed in which the floor of the bed slopes upwardly toward the head end. [0028] FIG. 14 is a perspective view of yet another embodiment of the frame of the infant bed in which the side panel extensions telescope with their respective side panels, and a fabric cover joins the components and forms a foot end wall. [0029] FIG. 15 is a perspective view of the embodiment of the frame structure of FIG. 14 , shown with the side panel extensions fully deployed. [0030] FIG. 16 is a cross-sectional view taken along line 16 - 16 of FIG. 14 . [0031] FIG. 17 is a cross-sectional view taken along line 17 - 17 of FIG. 14 . [0032] FIG. 18 is an enlarged view of the clip-engaged side walls, taken along line 18 - 18 of FIG. 14 . DETAILED DESCRIPTION OF THE INVENTION [0033] The present invention generally comprises an infant bed that is designed for use in co-sleeping, in which the infant bed resides in the bed of a parent or other adult. With regard to FIGS. 1 and 2 , one embodiment of the infant bed includes a frame assembly 21 comprised of a rectangular base panel 22 and a head end wall 23 extending upwardly from the head edge of the panel 22 . A pair of side panels 24 and 26 extending upwardly from the opposed side edges of base panel 22 , and join the end wall 23 to form a coffer-like protected space 30 . The panels are provided with reinforcing ribs 27 and lightening holes 28 , as are well known in the prior art. Further, the upper panel edges are provided with a tubular lip 29 extending along the upper distal edges of the panels 23 , 24 , and 26 . Indeed, the reinforcing effect of end wall 23 joined to the side panels, together with the integral tubular lip, provides a structure that has significant resistance to deflection under vertical force. Thus an infant supported within a bed defined by the frame structure 21 is afforded substantial protection from the accidental and incidental impingement by adult bodies that may occur in a co-sleeping situation. The frame structure 21 may be enclosed in a fabric cover 31 , as shown in FIG. 4 . The fabric cover provides a soft surface treatment and may include a mattress pad, side pads, and other such features to enhance the comfort of the infant. Such features are described in U.S. Pat. No. 6,370,715 mentioned above and incorporated herein by reference. [0034] The head end wall, side panels, and base panel may be formed integrally by injection molding of polymer material, stamping of sheet metal or the like, or by assembly of the separate components using adhesive, ultrasonic welding, or the like. In the embodiment of FIGS. 1 and 2 , the frame structure 21 is depicted as integrally molded polymer material. [0035] A salient feature of the infant bed is the provision of a safety bar assembly 41 . In general, the safety bar assembly may comprise any arched or hoped structure that supports a hood-like structural arrangement, such as those common to baby carriages and the like, to divert objects that could impinge on the face or head of the infant within the infant bed. In the embodiment depicted in FIGS. 1-4 , the safety bar 41 is comprised of a tubular central portion 42 , and a pair of parallel legs 43 extending from opposed ends of the central portion 42 . A pair of mounting brackets 44 is provided, each secured to an outer surface of a respective side wall 24 and 26 . The distal end of each leg 43 is received in a respective one of the mounting brackets 44 . The mounting arrangement is configured so that the central portion 42 of the safety bar may be deployed across the area of the space 30 wherein the head of the infant will be resting. As explained below, the mounting system is designed to enable the safety bar to remain with the legs thereof in a generally vertical position to deflect pillows and other objects that might otherwise fall onto the face or head of the infant within the infant bed. [0036] In this regard it may be noted that the mounting brackets 44 are not centered along the length of the respective sidewall 24 or 26 . Rather, the brackets 44 are disposed adjacent to the portion of volume 30 in which the infant's head will be resting. This placement enables the safety bar 41 to be deployed to maximum effect when the legs 43 thereof are extending generally vertically upwardly from the mounting brackets 44 , so that the central portion 42 extends over the head of the infant for protection and the legs are oriented to resist any vertical loads from objects falling onto the safety bar. [0037] With regard to FIG. 6 , the mounting bracket 44 comprises a lug protruding from the sidewall and having a slot 47 formed therein generally parallel to the sidewall. A keyway 46 extends generally vertically in the lug in communication with the slot 47 . Each leg 43 includes a spade lug 48 at the distal end thereof, the spade being dimensioned to be received in the slot 47 . A key 49 protrudes from the lug 48 , and is formed in complementary fashion to keyway 46 , so that the spade lug and key may be inserted vertically into the slot and keyway. Likewise, the spade lug and key may be withdrawn vertically from the slot and keyway. As shown in FIG. 3 , within the bracket 44 there is an interior arcuate space 51 in which the key 49 may pivot after insertion through the keyway 46 . As a result, the legs of the safety bar may rotate within the mounting bracket 44 to permit the safety bar to rotate between the positions shown in FIGS. 1 and 2 . In addition, the mounting bracket is provided with a ball detent mechanism 52 which interacts with recesses 53 on the spade lug 48 ( FIG. 6 ), so that the safety bar is maintained at at least one predetermined angular relationship, such as the vertical position of maximum protection. [0038] The safety bar may also be provided with a light 54 secured in the middle of the central portion 42 of the safety bar. The light may be actuated selectively so that the parent or other adult may be able to view the face of the infant at rest in the infant bed 21 . The light power supply (battery or the like) and switch may be installed within the tubular structure of the safety bar, using techniques well known in the prior art. The safety bar 41 may also be used to suspend a toy or other visually stimulating object within the view of the infant at rest in the bed of the invention. [0039] With regard to FIGS. 4 and 5 , a further embodiment 21 a of the frame structure includes a rectangular base panel 22 a and a separate head end wall 23 a extending upwardly from the head edge of the panel 22 . A pair of separate side panels 24 a and 26 a extending upwardly from the opposed side edges of base panel 22 a, and join the end wall 23 a to form a coffer-like protected space 30 a. The panels are provided with reinforcing ribs 27 a and lightening holes 28 a as described previously, as are well known in the prior art. Further, the upper panel edges are provided with a tubular lip 29 a extending along the upper distal edges of the panels 23 a, 24 a, and 26 a. The safety bar 41 and the mounting brackets 44 are provided as described previously. In this embodiment, the frame components are not integrally formed; rather, the fabric cover 31 encloses the frame components and secures then in an assembly that provides protection for the infant resting within the infant bed. The fabric cover 31 includes a portion that spans the distal ends of the side panels and the base panel, and so forms an end wall at the foot of the bed. This foot end wall completes the enclosure of the coffer-like space 30 a and secures the infant within the bed. [0040] Furthermore, the tubular lip 29 a of the head end wall 23 a includes opposite end portions that curve approximately 90° to align with the tubular lip portions of the adjacent side panels 24 a and 26 a. Indeed, as shown in FIG. 7 , the adjacent tubular lip portions of the side panels and head end wall are disposed to interlock when the panels are assembled, thereby to secure the components and augment the vertical load-bearing strength of the frame assembly. The fabric cover 31 may be joined together with straps (including Velcro or snap fasteners) or zippers or the like, as shown in FIG. 4 , so that the frame components are joined to act cooperatively in a structure that is very resistant to vertical loads or lateral loads that might otherwise be imparted by the adults sleeping adjacent to the infant bed of the invention. The fabric cover may be opened and separated from the frame components for laundering, or for transporting the infant bed in a knock-down disposition. [0041] With regard to FIGS. 8 and 9 , a further embodiment of the invention provides a frame structure 21 b that includes a rectangular base panel 22 b and a separate head end wall 23 b extending upwardly from the head edge of the panel 22 b. A pair of separate side panels 24 b and 26 b extending upwardly from the opposed side edges of base panel 22 b, and join the end wall 23 b to form a coffer-like protected space 30 b. The panels are provided with reinforcing ribs 27 b and lightening holes 28 b as described previously, as are well known in the prior art. Further, the upper panel edges are provided with a tubular lip 29 b extending along the upper distal edges of the panels 23 b, 24 b, and 26 b. The safety bar 41 and the mounting brackets 44 are provided as described previously. In this embodiment, the frame components are not completely integrally formed; rather, the side panels 24 b and 26 b are foreshortened, and separate side panel extensions 24 b ′ and 26 b ′ are provided. [0042] The side panel extensions are joined to the remaining integral frame structure by any of the methods and structures shown herein. For example, as described before, a fabric cover 31 may be fashioned to enclose the frame components and secure then in an assembly that provides protection and comfort for the infant resting within the infant bed. The integrally formed head end wall, base panel, and foreshortened side panels 24 b and 26 b combine to form a strong structure that is highly resistant to lateral compression and vertical loads, and will protect the infant very well. Note also that the mounting brackets 44 extend from the side panels 24 b and 26 b, and the safety bar 41 is secured thereto to further protect the infant. The separate panel extensions 24 b ′ and 26 b ′ permit some yielding of the sides of the infant bed in the area of the legs and feet of the infant, a location that poses far less threat of injury to the infant. [0043] Referring to FIGS. 10 and 11 , a further embodiment of the invention provides a frame structure 21 b that is very similar to the embodiment of FIGS. 8 and 9 , and is accorded the same reference numerals for the same components. In this embodiment, the side panel extensions 24 b ′ and 26 b ′ are secured with hinges 61 to the distal side edges of the base panel 22 b. In particular, each side panel extension is provided at its lower edge with at least one hinge component consisting of a separable male hinge half, and each distal edge of the base panel 22 b is provided with at least one hinge component consisting of the separable complementary female hinge component, so that the hinge components may be joined as the confronting edges of the side panel extensions and the base panel are translated together ( FIG. 12 ). The hinged connections enable the side panel extensions to be deflected somewhat by the imposition of lateral force or vertical loads, but the structural effect of the fabric cover secures the side panel extensions in place without collapsing or otherwise threatening the well-being of the infant in repose in the bed. Once again the portion of the fabric cover 31 that spans the distal ends of the side panel extensions and base panel defines a foot end wall that secures the infant within the confines of the infant bed. [0044] A further embodiment of this concept is depicted in FIG. 14 , including a frame structure 21 b that is very similar to the embodiment of FIGS. 8-11 , and is once again accorded the same reference numerals for the same components. In this embodiment the side panels 24 b and 26 b are foreshortened, and the side panel extensions 24 b ′ and 26 b ′ are designed to slidably extend from their respective side panels. The tubular lips at the upper edges of each side panel and side panel extension are formed to be slidably telescoped together ( FIG. 16 ), whereby the extension may be slidably moved toward the distal end of the base panel. In addition, the lower edge of each side panel extension is provided with at least one edge clamp fitting 71 ( FIG. 18 ) that is adapted to resiliently clamp onto any portion of the side edge of base panel 22 b. Thus each side panel extension may be disposed at any position along the respective side edge of the base panel. [0045] Thus, for example, when the infant is newborn and rather small, the side panel extensions are disposed proximally, which reinforces the upper area where the infant is located. As the child grows, and more space is required, the side panel extensions may be moved distally, increasing the effective length of the sides and increasing the volume of the protected space 30 b. Eventually, the side panel extensions may be fully extended, as shown in FIG. 15 to maximize the capacity of the infant bed. [0046] A further embodiment 21 c of the infant bed, shown in FIG. 13 , is notable for the base panel 22 c sloping upwardly between side panels 24 c and 26 c, with head end wall 23 c joining the ends of the side panels and base panel. The slope of the base panel maintains the head of the sleeping infant in an elevated condition, which may be desired to facilitate unimpeded breathing by the infant. The side panels are foreshortened as in previous embodiments, and the side panel extensions are eliminated. The lower edges of the side panels and end wall are disposed in a common nominal plane to engage a supporting flat surface in a stable manner. The safety bar 41 and mounting brackets 44 are provided substantially as described previously to protect the head area of the infant. [0047] It should be emphasized that all of the embodiments of frame structures shown herein may be used advantageously with a fabric cover assembly that also supports other features such as pads, mattress, foot end wall, and the like. [0048] Thus the present invention provides an infant bed that is designed to enhance the safety and protection of the infant, so that it may be used in a co-sleeping arrangement. The strong frame structure, the safety bar, and the fabric cover combine to produce a superior infant bed construction. [0049] The foregoing description of the preferred embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and many modifications and variations are possible in light of the above teaching without deviating from the spirit and the scope of the invention. The embodiment described is selected 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 in various embodiments and with various modifications as suited to the particular purpose contemplated. It is intended that the scope of the invention be defined by the claims appended hereto.

1a

FIELD OF THE INVENTION This invention generally relates to surgical instruments; and more particularly, the invention relates to trocar devices for providing communication to the abdominal cavity. Trocar devices in accordance with the present invention include a substantially reinforced obturator shaft which adds rigidity to overcome unwanted deflection during penetration. BACKGROUND OF THE INVENTION A trocar is a surgical instrument that is used to gain access to the abdominal cavity. A trocar generally comprises two major components, a cannula and an obturator. In order to penetrate the skin, a small incision is made by the surgeon where the trocar is to be inserted. The distal end of the trocar is then inserted into the tissue. The obturator has a point or cutting edge at its distal end. By applying pressure against the proximal end of the obturator, the point is forced through the tissue until it enters a target location, such as the abdominal cavity. The cannula is inserted through the perforation made by the obturator and the obturator is withdrawn, leaving the cannula as an access to the abdominal cavity. Because trocars included sharp blades, inadvertent tissue or organ puncture was a concern. One of the first technical challenges in connection with the design and manufacture of the trocar was the incorporation of features to enhance safety. Specifically, it was important to develop a safety trocar which could substantially lessen the possibility of unintentional tissue or organ puncture. A trocar which includes a safety shield on the obturator was developed to lessen the possibility of unintentional puncture. The shield is biased in an extended position to cover the penetrating tip of the obturator. When the surgeon desires to penetrate tissue with the trocar, the safety shield retracts and exposes the penetrating tip. The shield remains in the retracted position so long as pressure is continuously applied. When the surgeon fully punctures the body wall, the pressure is relieved and the safety shield returns to its extended position covering the penetrating tip. Therefore, inadvertent puncture of bodily tissue and organs within the body cavity can be avoided. An example of a trocar having a safety shield is disclosed in U.S. Pat. No. 5,709,671 issued to Stephens et al. on Jan. 20, 1998, which is hereby incorporated herein by reference. While numerous trocars have been designed to prevent inadvertent puncture, there was still clearly room for improvement. Regardless of the safety mechanisms built into these instruments, there were concerns of accidental puncture to body organs. Therefore, other mechanisms for protecting tissues and organs from inadvertent puncture during surgery were developed. One such development in the design of trocars relates to the incorporation of visualization concurrently with penetration. An example of a patent which discloses a surgical penetration instrument adapted for visualization during penetration is U.S. Pat. No. 5,271,380 issued to Riek, et al. on issued Dec. 21, 1993, which is hereby incorporated herein by reference. This patent describes a penetrating instrument including a hollow, cylindrical sleeve and an imaging element attached to the sleeve at its distal end. In a preferred embodiment, it has a conical non-bladed penetrating tip to facilitate the advancement of the instrument into body tissue. The non-bladed obturator separates rather than cuts tissue while penetrating to gain access to a body cavity. In this way, the incorporation of a safety shield or another mechanism to protect tissue or organs from inadvertent puncture during insertion is unnecessary. The advancement of the optical non-bladed obturator reduced safety concerns and inadvertent tissue punctures encountered with early trocars; however, there was still opportunity for improvement. The trocars in the prior art are constructed of a large number of elements requiring various techniques in assembling the optical non-bladed obturator, creating manufacturing challenges. For example, manufacturers assemble the obturator by gluing the penetrating tip on the shaft of the obturator, or by using other mechanical means known in the art. Not only is the large number of elements a challenge to assemble, there is also a significant cost associated with assembling all of these elements. Many of the surgeons using the optical non-bladed obturator began using it without the aid of the imaging device. The surgeons found that they were comfortable performing the surgical procedures using tactile feed back. This surgical preference and the desire to reduce manufacturing challenges and costs led to the development of a one-piece solid plastic non-bladed obturator. The one-piece solid plastic non-bladed obturator enabled the use of conventional plastic processing methods such as injection molding, thus reducing manufacturing and assembly costs. Using injection molding, the one-piece solid plastic obturator had a straight injected molded plastic shaft. However, tests showed that the force required to penetrate tissue was great enough to cause unwanted deflection of the molded obturator shaft, especially on small diameter devices. This flexibility would be problematic during tissue penetration. This invention overcomes the obturator shaft deflection problem. SUMMARY OF THE INVENTION In accordance with the present invention there is provided an obturator for penetrating body tissue which contains a handle and a shaft. The shaft has a proximal end attached to the handle and a distal end extending from it. The handle and shaft are formed from a single piece of molded polymer. A substantially rigid reinforcing member which is formed from a material having a greater rigidity than the molded polymer is disposed along the shaft. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a trocar assembly including the obturator of the present invention. FIG. 2 is an exploded perspective view of the trocar showing the obturator and cannula separated. FIG. 3 is a plan view of the obturator of the present invention. FIG. 4 is an enlarged view of the penetrating tip of the obturator. FIG. 5 is an enlarged view of the penetration tip, shown in FIG. 4 rotated 90°. FIG. 6 is a cross-sectional view taken along line 6 — 6 of FIG. 5 of the preferred embodiment of the reinforced shaft of the obturator in the present invention. FIG. 7 is a cross-sectional view taken along line 6 — 6 of FIG. 5 of a second, alternate embodiment of the reinforced shaft of the obturator in the present invention. FIG. 8 is a cross-sectional view taken along line 6 — 6 of FIG. 5 of a third, alternate embodiment of the reinforced shaft of the obturator in the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Reference numerals are used in this description to designate the various components and elements of the instrument of this invention. Identical reference numerals designated in the various drawings refer to the identical element or component of the surgical penetration instrument. As used in this description, “proximal” or “proximally” refers to that portion of the instrument, component, or element which extends toward the user. Conversely, “distal” or “distally” refers to that portion of the instrument, component, or element which extends away from the user. Referring to FIGS. 1 and 2, there is shown trocar 2 which incorporates obturator 20 and cannula 8 of the present invention. As illustrated in FIG. 2, obturator 20 is inserted into and through valve 10 and into sleeve housing 14 and sleeve 12 . During insertion, an internal valve (not shown) connected to valve lever 18 is opened. Seal 10 is preferably a septum valve which surrounds shaft 22 preventing any fluid or gas from escaping through cannula 8 . When shaft 22 is fully inserted into cannula 8 , hub 24 is secured to sleeve housing 14 by handle 26 . Penetrating tip 32 of obturator 20 , and a portion of the distal end of shaft 22 , extend distally from sleeve 12 . In an actual surgical procedure utilizing the device of the present invention, a surgeon, using a scalpel, makes a small incision where trocar 2 , shown in FIG. 1, is to be positioned during the surgical procedure. The distal end of trocar 2 is then inserted into the tissue exposed by the small incision. After insertion into the tissue, trocar 2 is oscillated back and forth around its axis to facilitate penetration. Separators 34 and 36 on penetrating tip 32 help to separate tissue during oscillation to facilitate the advancement of trocar 2 into the abdominal cavity. After penetration into the abdominal cavity is complete, obturator 20 is removed from cannula 8 by pressing buttons 51 and 52 (not shown) which releases handle 26 from sleeve housing 14 . When obturator 20 is removed an internal valve (not shown) connected to valve lever 18 closes preventing any fluid or gas from escaping cannula 8 . If desired, a pressurizing gas such as carbon dioxide can be selectively pumped through sleeve 12 via stopcock 16 . Surgical instruments, such as linear staplers, graspers, clip appliers, scopes etc. can now be inserted through cannula 8 to perform a procedure at the surgical site. Referring again to FIGS. 1 and 2, cannula 8 includes sleeve 12 and sleeve housing 14 . Sleeve 12 extends distally from sleeve housing 14 . Sleeve housing 14 includes stopcock 16 , valve lever 18 , and seal 10 . Obturator 20 , as shown in FIG. 3, has a shaft 22 having a proximal end 42 attached to handle 26 , and a distal end 44 extending therefrom. Handle 26 and shaft 22 are formed from single piece of molded polymer. Shaft 22 preferably includes a conical penetrating tip 32 which is integrally molded to shaft 22 at its distal end 44 . Tip 32 includes first and second separators 34 and 36 which extend outwardly from penetrating tip 32 . Handle 26 has a cap 46 attached to the proximal end 42 of shaft 22 . Cap 46 is snapped onto handle 26 and is secured thereon by an interference fit. Referring now to FIGS. 4 and 5, penetrating tip 32 is molded integrally to shaft 22 at distal end 44 . Penetrating tip 32 has circular base 40 and blunt point 38 extending distally from base 40 . Base 40 is positioned adjacent to the distal end 44 of shaft 22 . First and second separators 34 and 36 , respectively, have generally straight, linear edge surfaces. Each first and second separator 34 and 36 extends longitudinally from adjacent to base 40 toward point 38 of penetrating tip 32 . First and second separators 34 and 36 are spaced about 180° from each other, and are positioned proximally to point 38 . Referring again to FIG. 3, shaft 22 further includes a reinforcing member 30 disposed thereon. In the embodiment illustrated in FIG. 6, member 30 is a rigid reinforcing hollow tube made of stainless steel, titanium or any other suitable material known to those skilled in the art. Using manufacturing methods like injection molding, a polymer such as polycarbonate, or any other suitable polymer known to those skilled in the art, can be injected through member 30 wile forming shaft 22 and handle 26 . Other manufacturing methods, readily apparent to those skilled in the art, could also be used to make the present invention. An alternate embodiment of the present invention is shown in FIG. 7 . In this embodiment, shaft 122 , similar to shaft 22 , includes a reinforcing member 130 disposed within the shaft 122 . Member 130 is a solid cylindrical rod made of a reinforcing material such as stainless steel, aluminum or any other material known to those skilled in the art. Using manufacturing methods like injection molding, shaft 122 and handle 126 (not shown) can be integrally molded as a single piece around member 130 . FIG. 8 shows another alternate embodiment, similar to that shown in FIG. 7, wherein shaft 222 includes of a member 230 disposed therein. Member 230 is similar to member 130 but has a plus shaped cross-section. As will be appreciated by those skilled in the art, many other suitable cross-sectional configurations other than circular and plus, can be used in the present invention. Although particular embodiments of the present invention have been shown and described, other embodiments will become apparent to those skilled in the art without departing form the spirit and scope of the present invention. The terms used in describing the invention are used in their descriptive sense and not as terms of limitations.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to apparatus for storing and sanitizing toothbrushes between uses and, more particularly, to a holder useful to store toothbrush bristles in individual canisters containing sterilizing solution which may be flushed by removing used sterilizing solution and adding fresh sterilizing solution, and having a lid for storing the toothbrush handle in a sterile environment. 2. Description of the Prior Art Toothbrushes are customarily stored when not in use in relatively unsanitary conditions. For example, after being used, toothbrushes are typically stored uncovered on shelves or in non-sanitized holders where they are exposed to any insects and germs or contaminants in the air. Toothbrushes stored in this manner are wet and possibly contain germs and food particles from the user's mouth, which are conditions that attract insects and promote the growth of bacteria and the spread of germs. The problem of unsanitary storage of toothbrushes has been recognized, and toothbrush holders which perform a sanitizing function by exposing the bristles of the brush to a germicidal agent are known in the art. Examples of such prior art are the disclosures in U.S. Pat. Nos. 5,086,916 and 4,585,119. In spite of these prior attempts to remedy the problem of unsanitary storage, studies show that unsanitary storage of toothbrushes remains the norm. This suggests that the prior art attempts at solutions have been defective in some way or unacceptable to toothbrush users for some reason. An object of this invention is to improve the apparatus of toothbrush sanitizing holders. A further object of this invention is to a provide a toothbrush sanitizing holder which is both simple and user friendly in its method of operation so as to promote the use of toothbrush sanitizing holders among toothbrush users. A further object of this invention is to a provide a toothbrush sanitizing holder which has individual storage chambers for preventing cross-contamination by direct contact between the individual toothbrushes. A further object of this invention is to provide a sterilizing toothbrush holder having a flush feature to facilitate the removal of used sterilizing solution and the addition of fresh sterilizing solution. A further object of the invention is to provide a toothbrush sanitizing holder having a replaceable reservoir of sterilizing solution of known and constant strength for repeatedly replenishing the solution in the storage chambers with solution of known and constant efficacy. A further object of the invention is to provide a toothbrush sanitizing holder which stores both the bristles and handle of the toothbrush in sterile environments while preventing the evaporation and contamination of the sterilizing solution. SUMMARY OF THE INVENTION Briefly stated, the objects are accomplished by a toothbrush holder useful for simultaneously storing and sanitizing toothbrushes between uses, and which is capable of being flushed by draining used sterilizing solution while simultaneously or subsequently adding fresh sterilizing solution. The holder may be used as a self-standing apparatus on a horizontal surface or may be mounted on a vertical surface. The holder consists of a toothbrush storage compartment having a storage canister for receiving and exposing the bristles of a toothbrush to a sanitizing solution. A reservoir of sanitizing solution is connected to the canister by fluid lines having unidirectional flow valves therein which permit solution to be transferred from the reservoir to the canister, but do not permit used solution to flow from the canister to the reservoir. The flushing of the individual canisters is accomplished by draining used sterilizing solution from the canister through a drain spout while either simultaneously or subsequently and independently adding fresh sterilizing solution from the reservoir. A removable lid with an elongated slot receives and holds the toothbrush handle in a sanitary environment and provides a closure for the toothbrush storage compartment. A viscous disinfectant in the lid is transported by an absorbent material to the slot where the handle is maintained in a sterile environment. BRIEF DESCRIPTION OF THE DRAWINGS A more complete understanding of the invention may be obtained by reference to the accompanying drawings wherein: FIG. 1A is an exploded, perspective view partially broken away of the invention. FIG. 1B is an exploded, perspective view partially broken away of another embodiment of the invention. FIG. 2 is a perspective view partially broken away of the invention. FIG. 3 is an exploded view of an assembly comprising the toothbrush 2, the toothbrush alignment member 40, the toothbrush flexing member 48, the bristle contacting element 50, and the canister 56 with the drain spout 57. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawings, a toothbrush holder and sanitizing apparatus 10 according to the present invention has a removable lid 12 in the form of a housing 14 having a top surface 16, front, back and side surfaces (not numbered), and a bottom surface 18. A chamber 20 in lid 12 stores a supply of a viscous disinfectant 24, and chamber 20 has a porous or permeable wall 22 which permits the disinfectant 24 to escape by seepage at a slow rate. In an alternative embodiment, chamber 20 is a prepackaged container having porous walls and which is filled with a viscous disinfectant. A first sponge or similar absorbent material 26 abuts the porous wall 22 and absorbs the viscous disinfectant 24 which seeps through porous wall 22. A second sponge or similar absorbent, pliable material 28 abuts first sponge 26 and has a slot 30 which is adapted to receive the handle 6 of toothbrush 2. First sponge 26 and second sponge 28 function to transport the absorbed viscous disinfectant 24 from chamber 20 to slot 30 where the toothbrush handle 6 will be exposed to disinfectant 24 and maintained in a sanitary environment. Sponge 28 is flexible and pliable so as to accommodate the variations in the shapes of toothbrush handles. The bottom surface 18 of lid housing 14 has an opening 32 which is aligned with toothbrush handle slot 30. The preferred viscous disinfectant 24 is a hypo chlorite, however, alternatives such as alcohol or any commercially available disinfectant non-injurious to oral tissues could be used to obtain the desired results. An input port 17 in housing top surface 16 permits the supply of viscous disinfectant 24 to be replenished. An alternative embodiment to the disinfectant chamber 20 having a permeable wall which permits disinfectant to escape by seepage can be a supply of disinfectant in a porous package which is in contact with the first sponge 26. A toothbrush aligning member 40 is positioned below bottom surface 18 of lid 12. Member 40 has a generally cylindrical shape with a top opening 42, a lower rim 44 and a bottom opening 46 having a circumference smaller than that of rim 44. Top opening 42 will be aligned with opening 32 in bottom surface 18. The lower rim 44 of member 40 will rest on the top of a toothbrush storage canister 56 and bottom opening 46 will fit into the top of canister 56. Referring to FIG. 3, a ring shaped element 48 is aligned with member 40 and canister 56. Element 48 has a flexing member 50 which is designed to contact and flex the bristles 4 to remove particles of food from the bristles each time the toothbrush is inserted or withdrawn from the storage compartment 54. Member 50 may consist of bristles or a flexible rubber insert in element 48. It will be recognized that flexing member 48 may be positioned in alignment member 40 or in canister 56, or in between alignment member 40 and canister 56. A toothbrush storage compartment 54 consists of a canister 56 having a top opening 58 and a closed bottom 60. A quantity of sterilizing solution 62 in canister 56 covers the bristles 4 of toothbrush 2 and the toothbrush handle 6 extends through the top opening 58. Canister 56 has first and second sanitizing solution input ports 64 and 66, preferably positioned on canister 56 above the point to which the canister will be filled with sanitizing solution. First and second sanitizing solution supply lines 68 and 70 connect the ports 64 and 66 on canister 56 to a sanitizing solution reservoir 80 and function as fluid conduits to transport sterilizing solution from reservoir 80 to canister 56. The canister 56 has a spout 57 (FIG. 3) which is normally closed but which may be opened to permit the canister to be flushed by the removal of used sterilizing solution through spout 57 and the addition of fresh sterilizing solution through solution supply lines 68 and 70. Unidirectional flow valves 72 and 74 in lines 68 and 70 permit sterilizing solution to flow from the reservoir 80 to canister 56, but prevent the flow of used sterilizing solution from canister 56 to reservoir 80. The toothbrush storage compartment 54 has a shelf 19 on which the lid housing 14 sits (see FIG. 2), and shelf 19 has an opening 33 therein which is aligned with the toothbrush handle slot 30, the bottom opening 32 in lid 12, and opening 42 of the toothbrush aligning member 40. The toothbrush storage compartment 54 has lateral sides 55 which receive and support the lid housing 14 and which extend downwardly to engage and rest on a pressure plate 82 which forms the top surface of a reservoir housing 81. A sterilizing solution reservoir 80 consists of a housing 81 having a depressable top side pressure plate 82. Housing 81 is designed to receive and hold a supply of sanitizing solution 84. Fluid supply lines 68 and 70 are connected through pressure plate 82 to the supply of sanitizing solution 84. In a first embodiment (FIG. 1A), the housing 81 receives a plastic bag or similar pre-filled, deformable container 86 of sterilizing solution 84. The bag 86 is connected to supply lines 68 and 70 and application of pressure on plate 82 causes the solution in bag 86 to be forced through lines 68 and 70 into canister 56. In an alternative embodiment, the housing 81 is designed to hold the sanitizing solution and is filled with sanitizing solution 84, whereby pressure exerted on reservoir housing top side 82 exerts pressure on the sanitizing solution 84 in housing 81 to force the solution to flow through supply conduits 68 and 70 into canister 56. In a third embodiment (FIG. 1B), the single deformable container 86 of sterilizing solution 84 is replaced by 2 pre-filled, deformable containers 86a and 86b which contain different sanitizing solutions 84a and 84b. The supply conduits 68 and 70 are connected directly to containers 86a and 86b, whereby pressure applied by hand or other means directly to containers 86a and 86b will cause sanitizing solutions 84a and 84b to flow through lines 68 and 70 to canister 56 where the two solutions combine to perform the sterilizing function. The use of pre-packaged bags of sterilizing solution affords a high degree of quality control over the purity, strength and efficacy of the sterilizing agent. Such pre-packaged containers of sterilizing agent can easily be replaced by removing the lines 68 and 70 from a depleted bag of sterilizing solution and attaching lines 68 and 70 to a fresh bag of solution. Alternatively, the entire reservoir assembly 80 may be removed and replaced as a unit by disconnecting the lines 68 and 70 from a depleted bag of sterilizing solution, removing the reservoir assembly consisting of the housing 81, the pressure plate 82, and depleted sterilizing solution container 86, and inserting therefor a replacement reservoir assembly unit consisting of a new housing 81, plate 82 and pre-packaged container 86 of fresh sterilizing solution. The sides 55 of toothbrush storage compartment 54 extend downwardly to engage and rest on the top surface of pressure plate 82 of the reservoir housing 81, whereby the application of a downward pressure on lid 12 will be transferred through the toothbrush storage compartment housing sides 55 to the reservoir pressure plate 82 to cause sterilizing solution 84 to flow through lines 68 and 70 to canister 56. The preferred sterilizing solution 84 is a hypo chlorite, but alternative antiseptic solutions such as alcohol or any of the commercially available disinfectants non-injurious to oral tissues could be used to obtain the desired results. It will be apparent that this invention is capable of application to store and sanitize a plurality of toothbrushes by providing a plurality of toothbrush storage canisters 56 which are each connected to the sanitizing solution reservoir 80 through conduits 68 and 70, and a lid 12 which has a number of slots 30 equal to the number of canisters 56 for receiving the handles of toothbrushes 2. It will also be apparent that a plurality of individual toothbrush holders each capable of holding and storing a single toothbrush may be mounted side-by-side on an appropriate mounting rack to provide the capability of holding and sanitizing a plurality of toothbrushes simultaneously. The toothbrush holder and sanitizing flush apparatus of the present invention is illustrated and preferably constructed of plastic for durability and ease of maintenance and cleaning. However, other materials such as ceramics and glass could be used to obtain the desired results. The toothbrush holder and sanitizing flush apparatus of the present invention is used by removing the lid 12 and inserting the bristles of a toothbrush through the bristle flexing member 50 and into the bottom of canister 56. The toothbrush handle 6 is then inserted into the slot 30 in lid 12 and the lid is then placed on toothbrush storage compartment 54. Then, a pressure on the top of lid 12 is transferred through storage compartment sides 55 to the reservoir pressure plate 82 to cause sufficient sanitizing solution 84 to be pumped through lines 68 and 70 to canister 56 to cover toothbrush bristles 4. The canister 56 is flushed by opening the flush spout 57 to permit used sterilizing solution and food particles flexed from the bristles to drain from the canister while fresh sterilizing solution is pumped into the canister from reservoir 80. The addition of fresh sanitizing solution may be accomplished either simultaneously with or subsequently to the draining of used solution from canister 56. This invention of a toothbrush holder and sanitizer flush apparatus provides a useful and hygienic apparatus for simultaneously storing and sanitizing toothbrushes between uses. It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the inventive concept thereof. It is understood, therefore, that this invention is intended to cover all modifications which are within the spirit and scope of the invention as defined by the appended claims.

1a

This application is a continuation-in-part application of U.S. application Ser. No. 08/405,979, filed on Mar. 17, 1995, now U.S. Pat. No. 5,714,582 which is hereby incorporated in its entirety. FIELD OF THE INVENTION This invention relates to the method and process for the production of collagen preparations from invertebrate marine animals including jellyfish and compositions of these preparations. These collagen preparations are useful in a variety of applications ranging from medical, pharmacological, and cosmetic. The composition is available as a mixture in a gel state, in a freeze-dried state, in a salt-reprecipitated state, and can be delivered as a mixture in a fluidized state, as a mixture in a gel state, and/or in association with surfactant/detergent combinations as an intact collagen molecule or as a hydrolyzed collagen product. The process for the production of collagen from invertebrate marine sources including jellyfish, takes advantage of the physical and chemical characteristics of jellyfish where the jellyfish is essentially a gelatinous state of collagen in water surrounding simple digestive systems and attached to other collagenous structures generally described as tentacles which are used in the capture of prey for the purpose of feeding. BACKGROUND OF THE INVENTION The term jellyfish refers to hundreds of species of primitive marine animals belonging to the class Scyphozoa, phylum Coelenterata. Coelenterata is a phylum name derived from the Greek words meaning “hollow gut”. It refers to important attributes of a group of invertebrate animals, called coelenterates, having a single internal cavity for digestion and excretion. Jellyfish often become abundant in coastal areas, particularly in late summer, and are regarded as a nuisance. Jellyfish sting swimmers, clog nuclear power plants, and fishing boat nets and, at times can cause severe damage to fishing nets owing to their huge volume and weight. In the water they are beautiful, colorful, and diaphanous creatures, yet most people only see them as a washed-up blob on the beach. Jellyfish can be found in both tropical and temperate waters of the world. The environmental factors affecting the occurrence of jellyfish are temperature, oxygen, salinity, and predation. Some species of jellyfish have great commercial potential. For example, the US coastal waters of the Florida Panhandle and all of the northern Gulf of Mexico provide an ideal environment for the seasonal proliferation of Stomolopus meleagris , which is commonly called the cannon-ball jellyfish. This species is found in abundance in certain areas of the world. For instance, it occurs from Southern New England, USA, to Venezuela and the Gulf of Mexico. One swarm observed at Port Arkansas, Tex., USA was estimated to have drifted through the channel at a rate of approximately 2 million per hour. Jellyfish occur world-wide, being caught in the Indian, Northwest Pacific and Western Central Pacific Oceans by Far Eastern countries including Thailand, Indonesia, Malaysia, the Philippines and China. In 1991, for example, the world harvest of jellyfish was 126,419 tons and Japanese buyers pay up to $25.00 per kilogram for large processed Grade “A” Rhopilema esculenta jellyfish. Fresh jellyfish contain approximately 95 to 98% water by weight, depending on the particular species and approximately 2 to 3% salt by weight, which is in approximate osmotic equilibrium with salt water. The contents of solids other than salt is extremely low; not much higher than 1% by weight. Protein content is approximately 1.3%. The lipid content of jellyfish is very low. On a wet-weight basis, lipid contents in the range 0.0046 to 0.2% have been reported. The nonpolar lipids of lyophilized jellyfish comprised 31.1% of the total lipids and sterols may account for approximately 47.8% of the nonpolar lipids. The cholesterol content of four species of coelenterates was in the range of 72.2 to 88.8% of the sterol content. Calculated from the above values, the cholesterol content on a wet-weight basis would be less than 0.35 mg/100 gm. Commercially available processed jellyfish contain approximately 5.5% protein, 25% salt and 68% water, however this type of jellyfish would be for consumption and would need to be desalted prior to consumption. As a food-stuff, the protein content of jellyfish in terms of protein level is similar to foods such as pasta and boiled rice. Jellyfish proteins consist almost entirely of collagen. Analysis of the amino acid composition of mesogloea hydrolysate showed that glycine is the most abundant amino acid, and that hydroxyproline and hydroxy lysine, which are characteristic of collagen, are present. Tryptophan is almost totally absent. Thus, mesogloea contain proteins belonging to the collagen group. SUMMARY OF THE INVENTION The present invention is concerned with the preparation of collagen compositions from invertebrate classes and species of marine animals constituting several hundreds of species of primitive marine animals, including species of jellyfish belonging to the class Scyphozoa, phylum Coelenterata. The present invention includes other classes of marine organisms and other species of invertebrates present in the marine environment where invertebrate type V collagen, the designation to be applied to collagens described by this present invention, possess similar physical and chemical characteristics. The present fibrous collagen products are unique and distinguished from previous collagen products formed from vertebrate animals species in that the marine invertebrate animals including jellyfish live and function in an environment different from that in which the vertebrate animal species live and function. For example, the marine jellyfish are found in salt-water environments hypertonic to vertebrate animals; are poikilothermal, i.e. have a body temperature that varies with the environmental temperature, and generally live and function at low temperatures compared to the body temperatures of most vertebrate species; live under variable pH conditions, but generally at pH values significantly less than “physiological” pH (pH 7.4) characteristic of vertebrate species; and lack significant tensile strength in their body structures. These attributes, i.e. pH, temperature, salt concentration, and tensile properties, represent important parameters used in the extraction and preparation of collagens from vertebrate species and thus, extraction and preparation of collagens from marine jellyfish would constitute a unique and novel process and the collagen preparation would have unique and novel properties even compared to type V collagen preparations from vertebrate species. In the present invention, invertebrate marine animals including jellyfish of various genera, are subjected to mild mechanical disruption followed by mild acid solubilization of the disrupted tissue. Collagens are precipitated by salts with mild shearing and/or by continuous dialysis and are formed into aqueous, gelled, precipitated, and/or mat/sponge preparations. The fibrous collagen preparation(s), constitute primarily invertebrate type V telopeptide containing collagen, and are useful in a variety of medical, dental, nutritional applications, and/or as component(s) of cosmetics and other pharmacologicals depending on the purity of the collagen preparation and/or heterogeneity of jellyfish components allowed to remain in the preparations. The fibrous aggregates may be used directly for a variety of purposes or may be cross-linked to provide fibers having substantial structural integrity and macroscopic dimensions. Depending on the intended usc of the fibrous materials, the fibers and/or other resident natural components may be treated in a variety of ways to prepare various articles of manufacture. An object of the present invention is to provide substantially pure marine invertebrate type V telopeptide containing collagen. A further object of the present invention is to provide a cosmetic composition containing marine invertebrate type V telopeptide containing collagen. Another object of the present invention is to provide a cosmetic cream composition containing marine invertebrate type V telopeptide containing collagen. An object of the present invention is to provide a cosmetic lotion composition containing marine invertebrate type V telopeptide containing collagen. An additional object of the present invention is to provide a shampoo composition containing marine invertebrate type V telopeptide containing collagen. An object of the present invention is to provide a hair conditioner composition containing marine invertebrate type V telopeptide containing collagen. A further object of the present invention is to provide a makeup formulation containing marine invertebrate type V telopeptide containing collagen. Another object of the present invention is to provide a colored cosmetic formulation containing marine invertebrate type V telopeptide containing collagen. A further object of the present invention is to provide a cosmetic composition containing marine invertebrate type V telopeptide containing collagen in an amount of from 0.001 wt % to 30.000 wt %. An object of the present invention is to provide a cosmetic composition containing marine invertebrate type V telopeptide containing collagen in an amount of from 0.1 wt % to 10.0 wt %. An additional object of the present invention is to provide a cosmetic composition containing marine invertebrate type V telopeptide containing collagen in an amount of from 0.5 wt % to 5.0 wt %. A further object of the present invention is to provide a process for preparing the present marine invertebrate type V telopeptide containing collagen by extracting, the collagen from a marine animal, in dilute acid; precipitating the extracted collagen, and washing the collagen precipitate. An object of the present invention is to provide fibrillar marine invertebrate type V telopeptide containing collagen. Another object of the present invention is to provide a cosmetic composition containing fibrillar marine invertebrate type V telopeptide containing collagen. An additional object of the present invention is to provide marine invertebrate type V telopeptide containing collagen in the form of a gel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Definitions In order to provide a clear and consistent understanding of the specification and claims, including the scope to be given such terms, the following definitions are provided. Cosmetic composition. By the term “cosmetic composition” is intended for the purposes of the present invention any composition or agent for external application to human or animal skin, nails, or hair for the purpose of beautifying, coloring, conditioning, or protecting the body surface containing a cosmetically effective amount of marine invertebrate type V telopeptide containing collagen. A cosmetically effective amount of such collagen is that amount required to bring about the desired cosmetic effect, with from 0.001 wt % to 30.000 wt % being preferred, 0.1 wt % to 10.0 wt % more preferred, and 0.5 wt % to 5.0 wt % being most preferred. One of ordinary skill in the art to which the present invention pertains can readily determine what constitutes a “cosmetically effective amount” without undue experimentation. The present cosmetic composition can be in any form including for example: a gel, cream, lotion, makeup, colored cosmetic formulations, shampoo, hair conditioner, cleanser, toner, aftershave, fragrance, nail enamel, and nail treatment product. Colored cosmetic formulation. By the term “colored cosmetic formulation” is intended for the purposes of the present invention those cosmetics containing pigment including for example eye shadow, lipsticks and glosses, lip and eye pencils, mascara, and blush. Conditioning agent. By the term “conditioning agent” is intended any agent or composition which exerts a conditioning effect on the body including the skin, hair and/or nails upon external application and includes for example humectants; emollients; oils including for example mineral oil; proteins including the present collagen; and shine enhancers including for example dimethicone and cyclomethicone. The present conditioning agents may be included in any of the present pharmacological and/or cosmetic compositions. Telopeptide containing. By the term “telopeptide containing” is intended for the purposes of the present invention a marine invertebrate type V collagen composition where the composition includes collagen molecules where the nonhelical terminal portions of the native collagen molecule, the telopeptides which extend as random coils from the amino and carboxyl ends of the collagen molecule, are retained. Atelopeptide containing. By the term “atelopeptide containing” is intended for the purposes of the present invention a marine invertebrate type V collagen composition where the composition includes collagen molecules where the nonhelical terminal portions of the native collagen molecule, the telopeptides, have been removed for example by enzymatic cleavage. Fibrillar collagen. By the term “fibrillar collagen” is intended for the purposes of the present invention, a natural polymeric form of collagen which is essentially insoluble in its aqueous environment yet forms a viscous gel-like matrix. Invertebrate marine animal By the term “invertebrate marine animal” is intended for the purposes of the present invention, invertebrate animals present in a salt-water or fresh-water marine environment and include for example members of the phylum Coelenterata, members of the class Scyphozoa and the phylum Coelenterata including for example jellyfish. Pharmacological compositions. By the term “pharmacological compositions” is intended for the purposes of the present invention any composition or agent applied externally to the skin, hair, or nails of the human or a animal body for therapeutic purposes containing a pharmacologically effective amount of the present marring invertebrate type V telopeptide containing collagen. A “pharmacologically effective amount” is that amount required to bring about the desired therapeutic effect, with 0.001 wt % to 30.000 wt % being preferred, 0.1 wt % to 10.0 wt % more preferred, and 0.5 wt % to 5.0 wt % being most preferred. One of ordinary skill in the art to which the present invention pertains can readily determine what constitutes a “pharmacologically effective amount” without undue experimentation. Examples of phannaceutical agents or compositions in accordance with the invention include ointments, creams, lotions, gels, solutions, and shampoos. More specific examples include for example, acne treatment preparations including creams, soaps, cleansers, moisturizers, ointments and lotions; anti-aging preparations including creams, cleansers, moisturizers and lotions; anti-dandruff preparations including shampoos and conditioners; antibiotic preparations; sunburn preparations; anti-itch preparations; and anti-fungal preparations. The present non-cross-linked or cross-linked fibrillar telopeptide containing collagen may be used directly as a gcl. As a gel, the fibrillar collagen can be used as a vitreous body or as dispersions/solutions for the preparation of cosmetic and pharmacological compositions. The fibrillar collagen can be cast into various forms at varying collagen fiber density and cross-linked to form mat or sponge-like structures which may be used in a variety of applications such as delivery of pharmaceutical agents to hair or skin, as artificial nails, as prosthetics, theatrical devices, etc. Articles of matter produced using marine invertebrate type V telopeptide containing fibrillar collagen are different from similar articles of matter produced using collagen preparations obtained from vertebrate species. A method is provided for preparation of commercially useful amounts of essentially type V collagen from marine jellyfish which may be formed into a variety of formulations and/or products. The collagen is most conveniently prepared from the whole organism, but the hemispherical bell-shaped transparent umbrella may be separated from the numerous fine marginal tentacles and reproductive and/or digestive structures present in the umbrella may be removed and the partial umbrella used in the production of various collagen preparations. Depending on the intended use of the derived fibrous materials, the native collagen may be freed of extraneous matter such as lipids, saccharides, and noncollagenous proteins so as to leave an essentially purified preparation of type V collagen. Another approach includes using fibrous materials in the preparation of a “natural” cosmetic such as a hair or skin cleaning/conditioning preparation and in this application of the present invention, the native collagen may be less extensively purified such that the natural material components of the jellyfish are retained in the product(s). The nonhelical terminal portions of the native collagen molecule, the telopeptides, extend as random coils from the amino and carboxyl ends of the molecules and may be retained or enzymatically removed in preparation of the final product(s). The telopeptides serve a number of functions in the formation of the native collagen fiber. The telopeptides serve as the primary sites for cross-linking intramolecularly (between the three constituent polypeptide chains in the native collagen molecule) and intermolecularly (between two or more native collagen molecules). In a preferred embodiment of the present invention, native essentially type V marine invertebrate telopeptide containing collagen is produced essentially free of noncollagenous proteins and other substances naturally present in marine jellyfish. This collagen is soluble in dilute aqueous acid, e.g. 0.01 M acetic acid, and 0.001 N HCl, and any insoluble collagen, if present, may be removed by filtration, centrifugation, or other means. In another preferred embodiment of the present invention, native essentially type V marine invertebrate telopeptide containing collagen is produced which retains appropriate noncollagenous proteins and/or polysaccharides naturally present in marine jellyfish. This collagen preparation is soluble in dilute aqueous acids and nonsoluble components and or tissue structures may be removed by filtration, centrifugation, or other means. Once the collagen solution is obtained, it may be employed for preparing fibrous aqueous solutions, fibrous aqueous gels, and dispersions/solutions of these products in surfactant solutions containing other ingredients suitable for the preparation of hair and skin treatments, and cosmetic and pharmacological compositions. The procedure for preparing the fibrous preparations involves a slow precipitation of the collagen from solution while subjecting the aqueous medium to mild shear (stirring). The conditions under which the precipitation of the collagen is achieved can vary. The temperatures employed are preferably in the range of from 0° C. to 42° C., more preferably from 10° C. to 30° C., and most preferably from 15° C. to 25° C. The pH is generally in the range of about 3 to 9, preferably in the range of 5 to 8, and more preferably between 6 and 7.5. A wide variety of salts may be used, usually alkali metal salts, both neutral and alkaline, more particularly sodium and potassium, with mono and polyvalent cation salts, particularly halides, e.g. chloride. The concentration of the salt may vary widely with the other conditions employed, e.g. temperature, and protein concentration, as well as the particular salt employed. Suitable concentrations are preferably in the range of from about 0.05 M to 4.0 M, more preferably from 1.0 M to 3.8 M, and most preferably between 2.5 M and 3.5 M. Suitable concentrations of polyvalent salts are in the range of from about 0.5 M to 4.0 M, more preferably from 1.0 M to 4.0 M and most preferred concentrations ranging from 2.5 M to 4.0 M. The concentration of collagen in the solutions being precipitated may range between 0.01 mg/ml and 10 mg/ml, preferably in the range of from 0.1 mg/ml to 5 mg/ml, and most preferably from 0.5 mg/ml and 4 mg/ml. Precipitation time varies from about 10 minutes to 5 hours, usually about 30 minutes to 2 hours, and preferably about 1 hour to 1.5 hours. Various techniques may be used to obtain the desired rate of precipitation of collagen while applying the mild shearing. One technique is heat gelation, wherein a constant or slowly increasing temperature is employed to bring about precipitation of collagen in the presence of salt. Generally, the temperature range is from about 4° C. to 45° C., the temperature being slowly raised from about 4° C. to 10° C. to a temperature of about 20° C. to 37° C. Salt concentrations generally vary from about 1.0 M to 4.0 M. Alkali metal halides, e.g. sodium chloride, are preferably employed. The pH is generally from 4.0 to 8.0, preferably 5.0 to 6.0. Particularly preferred conditions are nonphysiological conditions for the jellyfish, namely 3.5 M NaCl, pH 5.0, with a final temperature of about 35° C. A second technique is to provide a slow increase in ionic strength, pH, and temperature with the collagen in solution. This can be achieved by employing dialysis with a monovalent or polyvalent salt dialysate, thereby slowly raising the salt concentration (or ionic strength) while the acid in the collagen solution diffuses from the collagen solution into the dialysate. The change in pH can be either continual or incremental, typically by employing alkali salts in the dialysate. Usually the dialysate has a salt concentration of 1.0 M to 4.0 M, more usually to 2.5 M to 3.8 M, particularly of disodium phosphate. The final pH of the medium is generally 3.0 to 8.5, more usually 4.0 to 6.5, and preferably 5.0 to 5.5. Another procedure is that of continuous dialysis at moderately reduced to low temperatures while changing the dialysate from a dilute mildly acidic solution to (generally a mild mono or dicarboxylic organic acid or dilute mineral acid such as HCl) to a mildly basic salt solution, while increasing the ionic strength or salt concentration by using a dialysate of increasing salt concentration. With increasing ionic strength or salt concentration, the temperature of the solution may also be increased, until a fibrous mass of obtained. The fibrous mass is freed of any nonfibrous materials and may be treated in a variety of ways depending on the intended use. Another use of the present collagen preparations include the addition of the preparation into solutions of surfactants, detergents, soaps, and similar formulations for use with treatment of hair and skin as a cosmetic, a cosmetic ingredient, and/or pharmacological agent. The term “cosmetic ingredient” is the same as “cosmetic composition” and means a composition applied externally to skin, nails, or hair of the human or animal body, for purposes of beautifying, coloring, conditioning, cleansing, or protecting the bodily surface. Examples of cosmetic ingredients or cosmetic compositions in accordance with the invention include lotions, creams, moisturizers, gels, sun screens, makeup, cleansers, soaps, shampoos, hair conditioners, skin firming compositions, protein concentrates, after shaves, colored cosmetics including for example eye shadows and blushes, nail enamels, and so forth. Animal collagen is known to have moisturizing and film forming properties, and is a popular additive to treatment cosmetics. The term “pharmacological agent” is the same as “pharmacological composition” and means a agent or composition applied externally to the skin, hair, or nails of the human or a animal body for therapeutic purposes. Examples of pharmaceutical agents or compositions in accordance with the invention include ointments, creams, lotions, gcels, soaps, solutions, and shampoos. Animal collagen protein is the main component of connective tissues and animal keratin is the main component of hair and fingernails. Collagen is responsible for most of skin structure. In the course of aging the polypeptide chains of collagen polymerize. The result is “cross-linking”, which causes wrinkling of the skin as well as reduction in skin elasticity. Keratin is responsible for the most of hair structure. In the course of hair growth, the keratins dry out and exhibit cracks in surface structure of hair. Collagens are natural film forming agents and aid in prevention of drying. The present collagen preparation can be added to a typical shampoo composition by weight, an example of which is set forth below: Weight Trade Name CTFA Name Percent Sulfotex UBL 100 acid Dedecybenzene Sulfonic Acid 3.0 Triethanolamine Triethanolamine 1.7 DI water 50 Invertebrate Type V Collagen 0.5 Panthenol Panthenol 0.24 Sulfotex LMSE Sodium Laureth Sulfate 15.0 Sulfotex WA Sodium Lauryl Sulfate 10.0 Germaben II Propylene Glycol 56.0 Diazolidinyl Urea 30.0 Methyl Paraben 11.0 Propyl Paraben 3.0 Ninol LL-50 Lauramide DEA 7.0 DC 929 Amodimethyl (and) Nonoxynol-10 and Tallowdimonium Chloride 1.0 D&C Yellow # 5 Solution 0.04 Clindrol SEG Glycol Stearate (optional) 2.0 In addition, the present material can be added to various formulations of skin care products generally described as lotions for application to human facial or body skin. These lotions generally contain from about 20-80% oil and 10-80% water in an emulsion form. In addition, the moisturizing lotion may contain humectants, emollients, surfactants, fragrances, preservatives, and so forth. About 5-10% humectant, about 5-20% emollient, and about 0.5-10% surfactant are suggested. Marine invertebrate Type V telopeptide containing collagen (at about 0.01 to 1.00 wt %) and hydrolyzed collagen (at about 0.1 to 2.0 wt %) products may be incorporated into moisturizing creams. Creams generally contain from about 20-70% water and about 30-70% oil. In addition, creams may contain a variety of humectants, emollients, surfactants, preservatives, and fragrances. About 5-10% humectant, about 5-20% emollient, and about 0.5-10% surfactant are suggested. Marine invertebrate Type V telopeptide containing collagens (incorporated at about 0.01 to 5.0 wt %) and hydrolyzed collagen (incorporated at about 0.1 to 10.0 wt %) products may be incorporated into treatment makeups. Generally, makeup formulations comprising 5-70% oil, 10-95% water, and about 5-40% pigment, are suitable. In addition, the makeup as well as any of the present cosmetic or pharmacologic compositions may contain other components known and readily selected by those of ordinary skill in the art to which the present invention pertains. For makeup formulations such components may include for example surfactants, preservatives, silicone, humectants, emollients, and fragrances. Generally 0.5-10% surfactant, 0.1-30% silicone, 5-10% humectant, 0.1-30% emollient, and 0.1-5% preservative are included. Marine invertebrate Type V telopeptide containing collagens (about 0.2 to 2.0 wt %) and hydrolyzed collagen (about 0.01 to 5.00 wt %) products may be incorporated into colored cosmetics such as eye shadow or blush. For example, a suitable eye shadow comprises 5-40% pigment, 1-50% oil, and 1-20% waxes. Additionally, the composition may contain one or more of 10-60% water, 0.5-30% surfactant, 1-10% humectants, 0.1-5% preservative, and 0.1-20% silicone. Invertebrate Type V collagens (about 0.01 to 2.00 wt %) and hydrolyzed collagen (about 0.01 to 5.00wt %) products may suitable for incorporation into shampoos and hair conditioners. Suitable shampoo formulations include 1-40% surfactant and 10-90% water. Suitable hair condition formulations include 30-95% water, 0.5-30% conditioning ingredients including for example, emollients, proteins, and shine enhancers, and 1-40% surfactant. Hair conditioners and shampoos may also contain thickeners and silicone. About 0.05-5% silicone is suggested in shampoos and hair conditioners. The invention includes cosmetic and pharmaceutical compositions containing a cosmetically or pharmaceutically effective amount of invertebrate type V telopeptide containing collagen protein. A cosmetically and/or pharmacologically effective amount of collagen protein in accordance with the invention is that amount required to bring about the desired cosmetic and/or therapeutic effect. Such amount can readily selected by one of ordinary skill in the art to which the present invention pertains based on the particular formulation and the desired effect, without undue experimentation. Preferably, about 0.001-30 wt %, more preferably 0.1-10 wt %, and most preferably 0.5-5 wt % is employed. In describing the present invention, three stages will be considered. The first stage is the purification of native collagen and its transformation into collagen in solution. The second stage is the transformation of the collagen in solution into native fibrous polymers. The third stage is the use of the native collagen, collagen in solution, and fibrous polymers, for the fabrication of various articles or the formation of composites. Suitable collagen sources include a wide variety of marine animals such as those of the phylum Coelenterata. Collagen dispersions or solutions obtained from the mantle, tentacles, and whole organism provide similar collagen dispersions or solutions. First the reproductive and digestive tissue structures and tentacles, are removed from the organism. The mantle portion of the jellyfish provides the most uniform materials for production of collagen dispersions or solutions with the least amount of noncollagenous protein material(s). For purposes of this invention, collagen dispersion or solutions are defined as aqueous compositions where the collagen does not settle away from the aqueous composition under normal conditions of preparation and storage. To enhance the ease of purification and facilitate dispersion/solubilization of collagens, the material is subjected to various mechanical treatments such as dissection, grinding, high speed shearing, and the like. Depending on the particular treatment, the tissue may be wet or dry, frozen or cooled, high speed shearing is preferably carried out with frozen or cooled wet tissue, and grinding is preferably carried out with dry cooled tissue. Coarsely divided tissues are swollen in aqueous acidic solutions under nondenaturing conditions. Further dispersion is achieved using high speed shearing in short bursts. Preferably dilute acid solutions at low temperatures are employed to minimize denaturation. Suitable acids include acetic, citric, malonic, or lactic acids, or other carboxylic acids having pK values from about 2 to 5 at room temperature. Dilute mineral acids such as HCl may also be used provided the pH of the dilute acid solution is approximately 2 to 5. Concentrations of the organic acid in the dispersion medium typically range from about 0.01 M to 1.0 M and the temperature may vary from 4° C. to about 25° C. Preferably, 0.5 M acetic or citric acid solubilization for 2-3 days yields a collagen dispersion which may be filtered through cheesecloth. The acid soluble extract may be dialyzed against sodium phosphate buffer and the formed precipitate redissolved in 0.5 M acetic or citric acid. Solid NaCl may be slowly added to the acid solubilized preparation to a final concentration of about 3.5 M to effect secondary precipitation. Precipitated collagen dispersion may be redissolved in dilute acid and freeze-dried. Preparation of atelopeptide collagen dispersion may be accomplished by solubilizing collagen or dissolving the freeze-dried collagen preparation in dilute acid and digesting the materials with 4-10%, weight per weight, pepsin, ficin, collagenase, trypsin and pronase at 4° C. After 24 hours, the digest may be dialyzed against sodium phosphate and precipitated by addition of solid NaCl and/or the dialysate may be concentrated by freeze-drying. The formed precipitate may be redissolved in dilute acid and freeze-dried. In the present invention, mantle from jellyfish is a preferable source of collagen, where the collagen-containing material is separated from adjacent tissues by dissection, soaked in dilute acid at room temperature and ground using short bursts of high speed shear (for example, using a blender). This technique provides a homogeneous dispersion of jellyfish which is readily available to subsequent treatment, so as to provide an efficient means for achieving collagen in solution. The dispersion which is obtained by treatment with acid is a viscous dispersion containing native (telopeptide containing collagen) fibrillary collagen and a small amount of native collagen in solution. The viscous product, i.e. dispersed swollen collagen, is marine invertebrate type V telopeptide containing collagen of the composition alpha1alpha2alpha3. Enzymatic treatment may be used at this point to remove telopeptides producing atelopeptide fibrillar collagen while leaving the major portion of the molecule intact. Illustrative enzymes include for example, pepsin, ficin, collagenase, trypsin, and pronase. Depending on the particular enzyme employed, conditions for enzymatic cleavage of the telopeptides vary. With pepsin an acidic solution is employed, generally at a pH of about 2 to 4. The concentration of the enzyme varies from about 0.001 to 10 wt % based on the weight of collagen present. The collagen concentration generally varies from 0.5 g/l to 10 g/l, more usually from about 1 g/l to 5 g/l. Preferably, the acidity is provided by an organic acid such as a carboxylic acid in a concentration of about 0.01 M to 1.0 M. If necessary, the pH can be adjusted by the addition of a mineral acid, e.g. hydrochloric. The solution of soluble fibrillar collagen is then treated to separate the soluble fibrillary collagen from soluble noncollagenous materials. Primarily, the treatment involves separations, precipitations, and dialysis against various solutions of different ionic strength known to those of ordinary skill in the art, and readily selected and employed by those of ordinary skill in the art to which the present invention pertains without undue experimentation. Moderate temperatures are employed, normally between 0° C. and 20° C., and salt solutions of varying ionic strength and salt concentration, generally from about 0.01 M to 4.0 M. depending on the particular salt. Neutral salt solutions, e.g. NaCl, of about 0.5 M to 4.0 M may be employed as a dialysate in a free-flow dialysis at a pH of at least 5 and not greater than about 9. Non-soluble contaminants which have been precipitated during preparation of soluble fibrillar collagen are filtered off to yield a filtrate which contains atelopeptide containing collagen in solution. The collagen in dispersion/solution (telopeptide and/or atelopeptide) is precipitated as a part of a purification scheme, for example by adding a neutral salt to the solution to a concentration of about 1.0 M to 4.0 M, preferably 3.5 M. Various alkali metal halides, e.g. NaCl, may be used. The resulting precipitate is isolated, for example by centrifugation. Further treatment includes exchanging with a dilute carboxylic acid, e.g. acetic acid (0.05 M to 0.5 M) in the presence of aqueous NaCl (0.001 to 0.1 weight percent) with precipitation by addition of NaCl (1 to 4 M) and resolubilization to insure the purity of the collagen. Specifically, the procedure may involve an initial precipitation by use of a neutral salt (at least 10 to 30 wt %), isolation of the precipitate, redissolving in dilute acid, e.g. a carboxylic acid of about 0.05 M to 1.0 M, filtration, reprecipitation of the collagen with about 2 to 10 wt % aqueous salt solution, isolation, redissolution with a dilute carboxylic acid, with repetition of the purification process until the desired degree of purity. The collagen is then resuspended in dilute acid solution, generally a carboxylic acid such as acetic or citric acid at a concentration of about 0.01 M to 0.5 M. Activated charcoal can be added in particle tight containers or the collagen can be dialyzed to remove low molecular weight solutes which might present undesirable odors or fragrances. Precipitation of the collagen can be achieved in a variety of ways, including for example, the addition of neutral salt, and decrease in pH in the presence of neutral salt. Preferably, mild conditions are employed to prevent denaturation and disruption of the natural fibrillar character of collagen. The collagen dispersion may then be concentrated, for example by dialysis, to a concentration of about 1 mg/ml to 20 mg/ml. The clear solution of collagen is relatively free of higher aggregates, is viscous, and consists essentially of marine invertebrate type V fibrillar collagen. In the preparation of cosmetic or pharmaceutical products using the present invention, marine invertebrate type V collagen can be used in effective amounts of about 0.001 to 30 wt % of the collagen protein preparation, with 0.01 to 10 wt % preferred, and 0.5 to 5 wt % most preferred. The collagen proteins may be incorporated into suitable cosmetic or pharmaceutical vehicles such as lotions, creams, ointments, gels, shampoos, conditioners, or solutions. Suitable ointments are hydrophilic ointments (USP) or petrolatum and cosmetically effective amounts of collagen protein are incorporated into the ointment for topical application to skin or hair. Suitable lotions and creams are as mentioned previously for cosmetic compositions. Solutions are made by mixing solutions of collagen protein in deionized water for application to human or animal skin and hair. Gels are made by mixing 1-90% water with a suitable polymer. Suitable humectants for use in the cosmetic compositions of the present invention include for example glycerin, propylene glycol, butylene glycol, urea, sorbitol, sodium PCA, gelatin, polyethylene glycols, sodium lactate, and hyaluronic acid. Suitable emollients include for example glyceryl stearate, cetyl alcohol, stearyl alcohol, isopropyl stearate, stearyl alcohol, stearyl stearate, isopropyl stearate, stearic acid, isobutyl palmitate, isocetyl stearate, oleyl alcohol, sebacates, myristates, palmitates, squalenes, glyceryl monooleate, oleic acids, lanolin, acetylated lanolin alcohols, petrolatum, mineral oils, palmitic acids, and isostearyl neopentanoate. A variety of surfactants can be used in the compositions of the invention including amphoteric, anionic, cationic, or nonionic surfactants. Suitable amphoteric surfactants include imidazolines, betaines, and amino acid salts. Suitable anionic surfactants include for example fatty acid soaps, salts of higher alkyl sulfates, n-acyl sarcosinates, salt or phosphates, sulfosuccinate salts, alkyl benzene sulfonatcs, salts of N-acyl glutamate, and polyoxyethylene alkyl ether carboxylic acids. Cationic surfactants include for example alkyl trimethyl ammonium salts, alkyl pyridinium salts, alkyl quaternary ammonium salts, and polyamine fatty acid derivatives. Nonionic surfactants include for example lipophilics such as sorbitan fatty acid esters, glycerol fatty acids, propylene glycol fatty acid esters; hydrophilics including for example polyoxyethylene sorbitan fatty acid esters, polyoxyethylenc glycerol fatty acid esters, polyoxyethylene fatty acid esters, polyoxyethylene alkyl ethers, pluronics, polyoxyethylene alkyl phenyl ethers, and polyoxyethylene propylene glycol fatty acid esters. Suitable pigments include for example organic and inorganic pigments such as talc, mica, titanium dioxide, titanated mica, iron oxides, ultramarines, chromium oxides, carmine, D&C, and FD&C colors and lakes, ferric and ferrous oxides. Suitable waxes include for example beeswax, camauba, ceresin, microcrystalline, lanolin, candelilia, cetyl alcohol, cocoa butter, petrolatum, hydrogenated caster oil, spermaceti, bran wax, capok wax, and bayberry. The present invention is directed to a method of moisturizing and forming a film on human and animal skin, nails, or hair by applying to the surface and effective amount of invertebrate type V telopeptide containing collagen protein. An effective amount of collagen protein is about 0.001-30 wt %. The collagen protein may be applied directly to the surface in a solution form, or it may be incorporated into cosmetic or pharmaceutical compositions mentioned herein. The collagen protein or protein containing composition may be applied to the surface once or twice a day or as necessary. For example, if the collagen protein is incorporated into a facial moisturizer, usually one to two applications of moisturizer per day will provide a beneficial effect. If the collagen proteins are incorporated into shampoos or hair conditioners, usually application once a day or every other day will be sufficient to provide a beneficial effect. When collagen proteins are incorporated into makeups, blushes, or eye shadows, they provide a treatment effect to the skin when applied once a day or whenever makeup is worn. If incorporated into nail treatment products or nail enamels, consistent usage in a nail care regimen (i.e. once or twice a week) will provide beneficial results. The invention will be further described in connection with the following examples which are set forth for the purposes of illustration only. EXAMPLE 1 Preparation of Marine Invertebrate Type V Telopeptide Collagen Gel Cannon-balljellyfish were dissected to separate the mantle from the tentacles and the reproductive and digestive organ was dissected from the mantle. The mantle was then cut into small pieces and placed into dilute (0.5 M) citric acid such that 10 mantles of average sized jellyfish (8-12 inches in diameter) were placed into 4 liters of citric acid solution. The container was covered to restrict evaporation and refrigerated at between 4° C. and 10° C. for three (3) days. The viscous collagen solution was filtered through 4 layers of cheese-cloth and the viscous materials precipitated by the addition of solid sodium chloride to a final concentration of 3.5 M. The sodium chloride was added in small increments and the precipitated materials removed as formed by the salt precipitation. Essentially all of the collagen was thus precipitated by the addition of sodium chloride and transferred to a separate container. The precipitated collagen was then gently and quickly washed with distilled water to remove associated salt crystals and then 1 liter of 0.5 M citric acid solution was added to resolubilize the precipitated collagen. This aqueous solution of invertebrate type V collagen was stored in a tight container, to prevent evaporation, under refrigeration until used. By sampling aliquots of this collagen preparation it was determined that the collagen content was 2.5% by weight. A particle tight container of activated charcoal was added to the collagen preparation during storage to reduce odors. EXAMPLE 2 Preparation of Marine Invertebrate Type V Telopeptide Collagen Solution In this example, cannon-ball jellyfish were dissected to separate the mantle from the tentacles and the reproductive and digestive organ was dissected from the mantle. The tentacles were then cut into small pieces and placed into dilute (0.5 M) citric acid such that tentacles from 10 average sized jellyfish (8-12 inches in diameter) were placed into 2 liters of citric acid solution. The container was covered to restrict evaporation and refrigerated at between 4° C. and 10° C. for three (3) days. The viscous collagen solution was filtered through 4 layers of cheese-cloth and the viscous materials precipitated by the addition of solid sodium chloride to a final concentration of 3.5 M. The sodium chloride was added in small increments and the precipitated materials removed as formed by the salt precipitation. Essentially all of the collagen was thus precipitated by the addition of sodium chloride and transferred to a separate container. The precipitated collagen was then gently and quickly washed with distilled water to remove associated salt crystals and then 1 liter of 0.5 M citric acid solution was added to resolubilize the precipitated collagen. This aqueous solution of invertebrate type V collagen was stored in a tight container, to prevent evaporation, under refrigeration until used. By sampling aliquots of this collagen preparation it was determined that the collagen content was 1.8% by weight. EXAMPLE 3 Preparation of Marine Invertebrate Type V Telopeptide Collagen Gelatin In this example, cannon-ball jellyfish were dissected to separate the mantle from the tentacles and the reproductive and digestive organ was dissected from the mantle. The mantle was then cut into small pieces and placed into dilute (0.5 M) citric acid such that 10 mantles of average sized jellyfish (8-12 inches in diameter) were placed into 4 liters of citric acid solution. The container was covered to restrict evaporation and heated to a temperature of 65° C. for 15 minutes (the solution appears to clear after approximately 10 minutes, however heating was continued until the solution temperature reached 70° C. at which time the collagen preparation was placed refrigerated at between 4° C. and 10° C. for three (3) days. The viscous gelatin solution was filtered through 4 layers of cheese-cloth and the viscous materials or aqueous solution of invertebrate type V gelatin was stored in a tight container, to prevent evaporation, under refrigeration until used. By sampling aliquots of this gelatin preparation it was determined that the collagen content was 2.8% by weight. A particle tight container of activated charcoal was added to the gelatin preparation during storage to reduce odors. EXAMPLE 4 Preparation of Marine Invertebrate Type V Telopeptide Collagen Solution In this example, cannon-ball jellyfish were dissected to separate the mantle from the tentacles and the reproductive and digestive organ was dissected from the mantle. The mantle and tentacles were then cut into small pieces and placed into dilute (1.0 M) acetic acid such that 10 mantles and associated tentacles of average sized jellyfish (8-12 inches in diameter) were placed into 2 liters of acetic acid solution. The container was covered to restrict evaporation and refrigerated at between 4° C. and 10° C. for three (3) days. The viscous collagen solution was filtered through 4 layers of cheese-cloth and the viscous materials precipitated by the addition of solid sodium chloride to a final concentration of 3.5 M. The sodium chloride was added in small increments and the precipitated materials removed as formed by the salt precipitation. Essentially all of the collagen was thus precipitated by the addition of sodium chloride and transferred to a separate container. The precipitated collagen was then gently and quickly washed with distilled water to remove associated salt crystals and then 1 liter of 0.5 M citric acid solution was added to resolubilize the precipitated collagen. This aqueous solution of invertebrate type V telopeptide containing collagen was stored in a tight container, to prevent evaporation, under refrigeration until used. By sampling aliquots of this collagen preparation it was determined that the collagen content was 3.2% by weight. A particle tight container of activated charcoal was added to the collagen preparation during storage to reduce odors. EXAMPLE 5 Preparation of Marine Invertebrate Type V Telopeptide Collagen-Freeze Dried In this example, cannon-ball jellyfish were dissected to separate the mantle from the tentacles and the reproductive and digestive organ was dissected from the mantle. The mantle and tentacles were then cut into small pieces and placed into dilute (1.0 M) acetic acid such that 10 mantles and associated tentacles of average sized jellyfish (8-12 inches in diameter) were placed into 2 liters of acetic acid solution. The container was covered to restrict evaporation and refrigerated at between 4° C. and 10° C. for three (3) days. The viscous collagen solution was filtered through 4 layers of cheese-cloth and the viscous materials precipitated by the addition of solid sodium chloride to a final concentration of 3.5 M. The sodium chloride was added in small increments and the precipitated materials removed as formed by the salt precipitation. Essentially all of the collagen was thus precipitated by the addition of sodium chloride and transferred to a separate container. The precipitated collagen was then gently and quickly washed with distilled water to remove associated salt crystals and then 1 liter of 0.5 M citric acid solution was added to resolubilize the precipitated collagen. This organic acid dispersion/solution of invertebrate type V collagen was then placed into dialysis bags and exhaustively dialyzed against deionized water at 0° C. (against crushed ice made with deionized water). This aqueous solution of invertebrate type V collagen was stored in a tight container, to prevent evaporation, under refrigeration until freeze-dried. By sampling aliquots of this collagen preparation it was determined that the collagen content was 3.2% by weight. A particle tight container of activated charcoal was added to the collagen preparation during storage to reduce odors. This deionized water dispersion of invertebrate type V collagen was carefully frozen in a freeze-drying vessel as to maximize the surface area to volume ratio, and freeze-dried. The freeze-dried collagen preparation was sealed under vacuum and stored at room temperature (for prolonged storage it is also possible to store this freeze-dried materials in a freezer at minus 20° C.). Prior to use in formulation of compositions containing this materials, the collagen was sheared in a Waring blender to achieve a fine powder and then reconstituted in 0.25 M citric acid. EXAMPLE 6 A collagen/gelatin containing oil in water moisturizing lotion was made as follows: Additive w/w % Glyceryl stearate 3.5 PPG-10 lanolin ether 0.5 Mineral oil 6.0 Lanolin alcohol 0.8 Oleic acid 2.8 Isocety stearate 10.0 Triethanolamine 1.3 Carbomer 941 0.1 Glycerin 9.0 Preservative 0.4 Collagen solution 5.0 Water qs 100.0 Marine invertebrate type V telopeptide containing collagen was used, preferably made according to example 1 or 2. EXAMPLE 7 An oil in water moisturizing cream was made as follows: Additive w/w % Glyceryl stearate 5.0 Cetyl alcohol 2.0 Stearyl alcohol 2.0 Isopropyl stearate 5.0 Mineral oil 13 Polysorbate 60 1.0 Glycerol 9.0 Zanthan gum 0.3 Preservative 0.5 Collagen solution 5.0 Hydrolyzed collagen solution 5.0 Water qs 100.0 Marine invertebrate type V telopeptide containing collagen was used. EXAMPLE 8 An oil/water cream makeup was made as follows: Additive w/w % Octyldodecy stearyl stearate 4.0 Isocetylstearate 1.5 Glyceryl stearate 5.5 Isotearic acid 2.0 Ceteth 10 1.0 Cyclomethicone 12.0 Stearyl alcohol 1.2 Nonionic surfactant 1.0 Binders and Thickeners 1.8 Titanium dioxide 8.0 Iron oxide 1.0 Propylene glycol 2.5 Triethanolamine 1.5 Preservatives 0.6 Collagen Gelatin solution 1.5 Water qs 100.0 Marine invertebrate type V telopeptide containing collagen was used, made according to any one of examples 1-5, more preferably made according to example 3, 4, or 5. EXAMPLE 9 A protein shampoo was made as follows: Additive w/w % Ammonium lauryl sulfate 9.0 Sodium dodecyl sulfate 1.0 Cocamide diethanolamine 4.0 Cocamidopropyl betaine 4.0 Ammonium chloride 0.8 Collagen solution 2.0 Water qs 100.0 Marine invertebrate type V telopeptide containing collagen was used, made according to any one of examples 1-6. EXAMPLE 10 A creme rinse hair-conditioner was made as follows: Additive w/w % Stearalkonim chloride 2.0 Cetyl alcohol 1.0 Stearyl alcohol 0.5 Stearic acid 0.5 Ceteareth 20 2.0 Xanthan gum 0.5 Dimethicone 0.2 Collagen Gelatin solution 0.2 Water qs 100.0 Marine invertebrate type V telopeptide containing collagen was used, made according to any one of examples 1-6. EXAMPLE 11 Preparation of a Natural Collagen Dispersion Cannon-ball jellyfish were gently homogenized using a mechanical grinder similar to that used to grind hamburger meat. The group materials were collected into suitable containers (5 gallon plastic pails with locking lids are suitable as are 55 gallon tanks) and citric acid was added in dry powder form to a final concentration of 0.5 M with constant stirring to dissolve and disperse the citric acid. The container was closed and stored under refrigeration (4-10° C.) for a minimum of 2 weeks. After two weeks, the containers were opened and the materials stirred using an electrically driven stirring device (an appropriate stirring device is one such as used to stir paint) to further homogenize the now viscous collagen preparation. The viscous collagen preparation was then filtered through fine screen wire to remove residual fragments of reproductive organs, and non-dispersed collagen/protein materials. The viscous clarified materials were returned to storage containers and stored under refrigeration until use. The produced natural collagen preparation is useful in formulations of a variety of products both hydrolyzed and non-hydrolyzed The natural collagen retains the natural salt and small molecular weight materials present in the source materials and can be preserved using chemical preservatives for storage without refrigeration, it can be diluted to provide less viscous collagen preparations, it can be heated to produce gelatin preparations. More specifically, this natural material is a base material which can be used with additional processing to produce the materials described in all other Examples. Although the present invention has been described with reference to the presently preferred embodiments, the skilled artisan will appreciate the various modifications, substitutions, omissions, and changes may be made without departing from the spirit of the invention. Accordingly, it is intended that the scope of the present invention be limited only be the scope of the following claims, including equivalents thereof. All references cited herein are hereby incorporated by reference in their entirety.

1a

FIELD OF THE INVENTION The invention pertains to lightweight, high-traction and self-cleaning horseshoes which provide excellent horse maneuverability and are particularly suitable for barrel racing, jumping, and similar competitive events requiring secure footing under variable terrain conditions. DESCRIPTION OF THE RELATED ART Conventional horseshoes utilize a relatively flat hoof engaging face which is nailed to the horse's hoof, and the ground engaging face of the horseshoe is of a generally convex configuration. Over the years horseshoe constructions have been proposed for improving the traction of the horse by forming ridges or protrusions which extend from the ground engaging face to penetrate the ground and improve the frictional resistance between the ground and the horse's shoed foot. Examples of previously proposed horseshoe constructions are found in U.S. Pat. Nos. DES 26,834; 295,616; 787,097; 895,367; 2,679,906 and 3,340,933. Patents such as those listed above disclose horseshoes having ridges or projections for increasing shoe friction with the ground surface, however, such shoes as those disclosed in the prior art have not enjoyed popularity among present day horse owners and equestrian event competitors. With present day equestrian competitive events, such as barrel racing, it is important that the horseshoes be light, and capable of providing excellent traction while taking tight turns at high speeds. Prior art horseshoes are usually too heavy for present day requirements, and because competitive events take place on a wide variety of ground types, such as sand, hard packed soil, loose dirt, clay impregnated soil, and the like, the self-cleaning aspects of prior art horseshoes have not met present day requirements. A further problem with horseshoes which are relatively lightweight due to minimizing the dimensions of the horseshoe, i.e. the vertical thickness and width, such horseshoes do not have the strength to resist the stresses imposed thereon when the horse takes a tight turn under gallop, such as occurs during barrel racing. The lateral stresses imposed upon the horseshoe cause the shoe to "open" or "spread" often tearing the hoof and injuring the animal. OBJECTS OF THE INVENTION It is an object of the invention to provide a lightweight, high traction and self-cleaning horseshoe which is economical to manufacture and may be nailed upon a horse using conventional shoeing techniques. Another object of the invention is to provide a lightweight horseshoe which has sufficient strength to resist deformation under lateral forces such as those encountered in barrel racing and the like. Yet another object of the invention is to provide a lightweight, self-cleaning, high traction horseshoe which cleans itself of accumulated soil, dirt, sawdust, and the like, and permit the sharp edges of the shoe required for improved traction to be accessible to the engaged ground. Yet a further object of the invention is to provide a lightweight, high traction, self-cleaning horseshoe which utilizes four ribs for increased traction purposes, the ribs being formed by converging surfaces defining included angles which permit self-cleaning, and the horseshoe is strengthened by homogeneous reinforcing bars intersecting the ribs which prevent spreading of the horseshoe due to lateral forces, and the construction permits the area adjacent the reinforcing bars to self clean. SUMMARY OF THE INVENTION In the practice of the invention the horseshoe consists of a steel or aluminum alloy body having hoof engaging and ground engaging faces. The vertical or height spacing between the faces is relatively small, but the shoe body is wider than usual to facilitate "floating" of the shoe and horse upon loose sand and soil. The ground engaging face of the shoe includes four ribs which extend the length of the shoe and are defined by surfaces which converge to relatively sharp apices to permit the apices to penetrate the ground and provide a relatively high friction. The front rib is formed by the intersection of the shoe body outer side and a converging ground engaging face surface, and this front rib constitutes a "grab" defining the maximum height dimension of the shoe whereby maximum earth penetration occurs at the shoe outer periphery. The included angle defined by the intersecting and converging surfaces defining the ribs is preferably greater than 50°, and such an angular relationship provides the self-cleaning of dirt received between adjacent ribs. Further, a dividing surface is centrally formed in the ground engaging face intermediate the outer and inner sides which aids in the self-cleaning characteristics, and the nail receiving holes are defined in this dividing surface. In order to minimize the material used in the horseshoe in order to achieve the desired light weight, and yet provide the horseshoe with sufficient strength to prevent lateral deforming or "opening" of the shoe due to lateral stresses being imposed on the shoe during tight high speed turns a pair of reinforcing bars are homogeneously formed in the horseshoe. The reinforcing bars are defined upon opposite sides of the shoe longitudinal axis and are of a vertical dimension greater than that of the ribs, but slightly less than the vertical dimension of the front grab rib and divide the ground engaging face into three parts. The ribs are substantially parallel to each other, and are so located as to provide the desired mass and strength at the most advantageous location to prevent horseshoe deformation under lateral forces, and yet not add significant weight to the horseshoe. To render the ground engaging face adjacent the reinforcing bars self-cleaning, slots are formed adjacent the front end of the reinforcing bars which intersect the horseshoe outer side. The slots have a lesser vertical dimension than the reinforcing bars exposing the bars lateral sides, and the presence of the slots permits the shoe to be self-cleaning adjacent the reinforcing bars. Experimentation has proven that horseshoes constructed in accord with the invention have superior friction and maneuverability characteristics to those horseshoes presently being used, and the self-cleaning aspects due to the particular configuration of the horseshoe has proven to be practical and effective. BRIEF DESCRIPTION OF THE DRAWINGS The aforementioned objects and advantages of the invention will be appreciated from the following description and accompanying drawings wherein: FIG. 1 is a bottom view of a horseshoe blank constructed in accord with the invention prior to the blank being bent into a typical horseshoe configuration, FIG. 2 is a front side elevational view of the formed blank shown in FIG. 1 as taken from the top of FIG. 1, FIG. 3 is an elevational sectional view taken along Section 3--3 of FIG. 1, FIG. 4 is an elevational sectional view taken along Section 4--4 of FIG. 1, FIG. 5 is an elevational sectional view taken along Section 5--5 of FIG. 1, FIG. 6 is an elevational sectional view taken along Section 6--6 of FIG. 1, FIG. 7 is a bottom view of a formed horseshoe in accord with the invention, and FIG. 8 is a front elevational view of the formed horseshoe as taken from the top of FIG. 7. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1 and 2 illustrate the form of the horseshoe blank 10 prior to being bent into the conventional C shape shown in FIGS. 7 and 8. Typically, horseshoe blanks are forged while in a linear configuration on die sets such as described in U.S. Pat. No. 2,679,906, and it is appreciated that the particular method for forming a horseshoe in accord with the invention should not be construed to limit the inventive concepts. A horseshoe utilizing the inventive concepts may be made by casting techniques as well as forging, swaging, or by other conventional metalworking processes. The blank 10 is of an elongated linear configuration usually formed of steel, or an aluminum alloy, having excellent wear characteristics. The blank 10 comprises the body 12 which includes a hoof engaging face 14 which is of a generally planar configuration, and remains planar after forming the blank into the finished C shaped configuration. The ground engaging face 16 of the body 12 is oppositely disposed to the face 14, and the body 12 also includes an outer side 18 which becomes the convex front side of the finished horseshoe, and an inner side 20 which becomes the inner or rear side of the finished shoe. The ends 22 of the body 12 are preferably radiused as illustrated. A front central portion of the blank 10 is defined at 24, and a rear central portion is formed at 26. A line substantially bisecting the portions 24 and 26 defines the horseshoe longitudinal axis 28 represented in FIG. 7. The primary frictional engagement between the horseshoe and the earth is due to the presence of four ribs 30, 32, 34 and 36, FIG. 3. These ribs extend the length of the body 12, FIG. 1, and are spaced across the width of the ground engaging face 16 between sides 18 and 20. The rib 30 is of the greatest vertical or height dimension and constitutes a "grab" defined at the periphery of the shaped horseshoe. The apices of the ribs 30, 32, 34 and 36 are indicated by numerals 38, 40, 42 and 44, respectively, and as will be appreciated from the drawings the rib apices are sharp for ease of ground and earth penetration. With particular reference to FIGS. 3-6, the grab rib 30 is defined by the body outer side 18 which intersects the surface 46 at the apex 38. Rib 32 is formed by intersecting converging surfaces 48 and 50, while rib 34 is defined by converging surfaces 52 and 54 and rib 36 is formed by converging and intersecting surfaces 56 and 58. The surfaces 46 and 48, and 54 and 56, intersect to define a valley, and the included angle defined by these intersecting surfaces is, preferably, greater than 50° to facilitate self-cleaning of dirt entering these valleys. A flat dividing surface 60 is centrally formed between the body sides 18 and 20, and is of a planar configuration parallel to the hoof engaging face 14. The dividing surface 60 separates the ribs 32 and 34, is not prone to trap dirt between these spaced ribs, and a plurality of nail holes 61 extend through the dividing surface 60 for receiving the nails for attaching the horseshoe to the horse's hoof in the known manner. In order to reduce the weight of the blank 10 the spacing between the faces 14 and 16 is relatively small, and this reduction in mass of the body 12 weakens the strength of the horseshoe body 12 with respect to lateral forces. As the horseshoe body 12 is primarily subjected to the compressive forces resulting from the weight of the horse and rider such compressive forces perpendicular to the plane of the hoof engaging face 14 are not inclined to deform the shoe. However, lateral forces imposed upon the shoe during rapid and tight turns by the horse during barrel racing, for instance, impose such forces as to "open" the C shaped configuration of the horseshoe nailed upon the hoof. To resist such lateral deformation the horseshoe of the invention includes homogeneous reinforcing bars 62 and 64 defined upon the ground engaging face 16. As will be apparent from FIG. 7, the reinforcing bars 62 and 64 are located upon opposite sides of the longitudinal axis 28, and define the termination of the front central portion 24 and the rear central portion 26. The bars 62 and 64 are obliquely related to each other when the horseshoe is in the form of the blank 10, FIG. 1, in order that the reinforcing bars will be properly related to each other in the finished horseshoe C shaped configuration of FIG. 7. Each reinforcing bar includes a front end 66 which intersects the body outer or front side 18, and each reinforcing bar includes a rear end 68 which intersects the blank rear or inner side 20. The free or lowermost surface 70 of the reinforcing bars is parallel to the face 14 and the surfaces 70 define the vertical dimension or height of the reinforcing bars. As will be appreciated from FIGS. 2, 4 and 6, the height of the reinforcing bars 62 and 64 is less than the height of the outer sides 18 as defined by the face 18 and the apex 38. The lateral sides of the reinforcing bars are represented at 71. The oblique angles of the reinforcing bars 62 and 64 as defined upon the blank 10, FIG. 1, are such that when the blank 10 is formed into the C configuration of FIG. 7, the bars 62 and 64 are almost parallel to each other and the longitudinal axis 28. This locating of the mass of the bars 62 and 64 upon opposite sides of the axis 28, and at the region of the horseshoe wherein lateral bending and deformation are most likely to occur, reinforces the formed horseshoe at the most critical locations to prevent the "spreading" or "opening" of the horseshoe and prevents damage from being inflicted upon the horse,s hoof without adding significant mass and weight to the horseshoe. As the dirt and soil will be forced against the reinforcing bar lateral sides 71 during turning there is a tendency for the dirt to pack against the reinforcing bars. However, it has been discovered that by slotting the front outer side 18 as will be appreciated from FIGS. 2 and 8, wherein a major slot 72 is formed on the outside of the associated reinforcing bar, and a minor slot 74 is located inside of the reinforcing bar that the presence of these slots permits the soil trapped against the reinforcing bars to fall free and render the horseshoe configuration self-cleaning adjacent the bars. The slot surfaces 76 have a height from the hoof engaging face 14 less than the height of the reinforcing bars 62 and 64 as defined by the surfaces 70, and the slots 72 are outwardly defined by the slot ends 78 while the inner slots 74 are inwardly defined by the terminating slot ends 80. By way of example, the relationships of the various components described above, dimensionally, may be appreciated. For instance, when forging the blank 10 to form a Size 2 horseshoe the overall length of the blank 10 will be approximately 13 inches, while the width of the body 12 is approximately 3/4 of an inch. The height dimension of the grab rib 30 as defined between the apex 38 and the face 14 is 3/8 of an inch, and this is the maximum height dimension of the shoe. The apices 40, 42 and 44 lie within a common plane which is 1/4 of an inch from the face 14, and the surface 70 of the reinforcing bars 62 and 64 is 5/16 of an inch from the face 14. The dividing surface 60 is located 1/8 of an inch from the face 14 as is the intersection of the surfaces 46 and 48, and 54 and 56. Accordingly, it will be appreciated from the above dimensions that the vertical height of the grab rib 38 is 50% greater than the vertical height of the ribs 32, 34 and 36. As will be appreciated from FIGS. 3, 5 and 6, the surface 58 which forms the apex 44 of rib 36 also intersects the body inner side 20, and the dimensions of the body 12 are such that the surface 58 provides additional mass "behind" the rib 36 to support the rib and strengthen the same against deformation. Forming the blank 10 from its elongated configuration to the C shaped configuration of FIG. 7 is readily accomplished within bending dies, and it will be understood that various sizes of horseshoes will use longer or shorter blanks depending on the desired final configuration. By making the shoe 3/4 of an inch wide between sides 18 and 20 the shoe tends to float on soft sandy surfaces, and by using sharp apices on the ribs excellent traction is provided on harder ground. As the reinforcing bars 62 and 64 divide the ground engaging face 16 into three portions, and as the presence of the slots 72 and 74 discourages accumulation of soil adjacent the reinforcing bars, the self-cleaning aspects of the horseshoe assure reduced weight at the horse's hoof, and by maintaining at least a 50° included angle between the ribs the tendency for soil to accumulate between the ribs is reduced. Of course, the spacing provided by the dividing surface 60 is also helpful in this respect. As described above, locating the reinforcing bars 62 and 64 at those locations most likely to deform the horseshoe under lateral forces permits the horseshoe to be strengthened at the most efficient locations without adding significant weight to the shoe. It is appreciated that various modifications to the inventive concepts may be apparent to those skilled in the art without departing from the spirit and scope of the invention.

1a

FIELD OF THE INVENTION This invention relates to an apparatus for applying continuous elastic strips to elastic leg disposable diapers. The elastic strips are adhesively secured continuously along the longitudinal edges of the disposable diaper and are alternately secured in stretched condition along the crotch area and in relaxed condition along the outer waist areas to form gathered and extendible side portions in the crotch area for elastic conformance with the legs of the wearer. DESCRIPTION OF THE PRIOR ART (PRIOR ART STATEMENT UNDER RULE 97) The invention relates generally to the problem of applying a continuous elastic strip alternately secured in stretched and relaxed conditions to a continuous strip or sheet of flexible but substantially non-stretchable material. Liebowitz, U.S. Pat. Nos. 2,681,019 and 2,681,020 both issued June 15, 1954, disclose sewing an elastic strip to a flexible compression-resistant substantially non-stretchable tape in order to put a variable compressive force on the tape to prevent curl in collars and girdles. The elastic strip is placed in alternating degrees of stretch before sewing to the non-elastic tape by tension forces arising between the point of sewing contact and the point at which the elastic strip is tangent to and slips off a stretching roller. Thus the tensile force appeared as a torque on the stretching roller, and is disclosed as a function of the rate at which the elastic strip is fed from the stretching roller and the distance that the elastic strip must travel from the stretching roller to the point of sewing contact. According to the Liebowitz patents, the rate at which the elastic strip is sewn to the non-elastic tape is essentially constant, since the sewing feed rate of the non-elastic tape is essentially constant throughout the machine in comparison to the rate at which alternations of stretch are impressed upon the elastic strip. In U.S. Pat. No. 2,681,020 the distance that the elastic strip travels from the stretching roller to the point of sewing contact is fixed, and the rate of feed from the stretching roller is alternating, in proportion to the rate of angular rotation of the stretching roller. The stretching roller is driven by the tensile force induced in the elastic tape by the sewing feed and is intermittently permitted to rotate an escapement mechanism attached to the stretching roller and synchronized to the sewing feed. In U.S. Pat. No. 2,681,019 the distance that the elastic strip travels from the stretching roller to the point of sewing contact is varied along with the angular rate of rotation and tangent velocity at the point at which the elastic strip slips offs the stretching roller, to obtain alternating stretch in the elastic strip as it is sewn to the non-elastic tape. This variation is obtained by employing an eccentrically mounted circular stretching roller, or by using a stretching roller with some other variation in the distance from the roller axis to the periphery of the roller, such as an elliptical variation. Thus a variation in the angular rate of rotation and tangent velocity at the point at which the elastic strip slips off the stretching roller produces a periodic variation even though the drive shaft of the stretching roller is permitted to rotate at a fixed rate, in synchronism with the sewing feed. As a consequence of the means for obtaining a variation in the tangent velocity of the elastic strip as it slips off the stretching roller, the distance from the tangent point to the sewing point also is varied. Liebowitz also appreciated, however, that the variation of the tangential velocity of the stretching roller, setting the elastic feed rate, and the variation of the distance from the tangent point to the sewing point, defining a path length, are independent contributions toward varying the tension in the elastic strip, and thus a variable tension may be obtained with a constant feed rate by cyclically interposing an idler pulley into the path of the elastic strip, thereby varying the path length. Gore, U.S. Pat. No. 4,239,578 issued Dec. 16, 1980, discloses applying a continuous elastic strip with alternating tension to the longitudinal edges of disposable diapers. Gore varies the tension in the elastic strip by varying the drive shaft angular velocity to the stretching roller, and thus achieves a constant path length from the stretching roller to the point of adhesion of the elastic strips to the disposable diapers. Pneumatic clutches are employed to switch the angular velocity of the stretching roller drive shaft between two different values. An adhesive applicator drum, which spreads adhesive onto the elastic strips and feeds them to the stretching roller, is also geared to the stretching roller. Thus the response of the stretching roller to the clutch engagement is limited by the inertia of the stretching roller and the adhesive applicator. Moreover, the maximum and minimum velocities reached by the stretching roller occur after the period during which the change in stretch is induced in the elastic strip. Teed, U.S. Pat. No. 4,261,782 issued Apr. 14, 1981, further discloses the method of alternately stretching and relaxing the elastic by periodically interposing an idler pulley into the path of the elastic in a diaper making machine. The displacement of the idler pulley varies the distance of travel of the elastic from a nip and stretching roller. The idler pulley is slowly displaced in a sinusoidal fashion by a crank shaft and is also quickly displaced intermittently by a piston and cylinder driven by compressed air. SUMMARY OF THE INVENTION The general aim of the present invention is to provide an apparatus for attaching continuous elastic strips with alternating stretched and relaxed condition to disposable diapers thereby creating gathered and extensivble side protions in the crotch area for elastic conformance with the legs of the diaper wearer. Moreover, it is an object of the invention to provide an apparatus for application of elastic strips wherein the diaper material is fed into and out of the elastic strip adhesion apparatus at a constant rate, and the elastic strips are also fed into the apparatus at a constant rate and receive adhesive at a constant rate. Furthermore, it is an object of the invention to provide means for imparting alternating stretch to the elastic strips by varying the tangential receiving rate at the bonding point. It is also an object of the invention to vary the difference in tangential elastic feeding and receiving rate by reciprocating rectilinear motion via a cam mechanism in order to eliminate friction clutches. Yet another object of the invention is to provide a cam profile which imparts a maximum and minimum tangenial receiving rate at the times during which the change in stretch is induced in the elastic strip, thereby maximizing the gradient of stretch of the elastic strip after it is bonded to the disposable diaper. The present invention involves the elastic adhesion step in the manufacture of disposable diapers typically composed of a highly absorbent material sandwiched between a fluid permeable facing sheet and a fluid impervious poly backing sheet. In accordance with the present invention, the disposable diaper poly backing is fed around a pivoted, oscillator frame which is driven by a cam via a cam follower secured to the oscillator frame. The poly backing is fed in and out of the oscillator frame by two feed rollers that are closely spaced from the pivot shaft along a line perpendicular to the oscillator frame radius, so that the poly feed rate is substantially constant in and out of the feed rollers as the poly is fed generally perpendicular to the oscillator frame radius. The poly travels radially from the pivot area to the bonding point at the end of the oscillator frame. The tangential velocity of the poly around the end of the oscillator frame is then the constant feed velocity plus or minus the tangential velocity of the pivot arm, as determined by the cam profile. A continuous elastic strip is fed at a constant rate over a stretching roller driven at a constant angular velocity, and adhesive is applied to the elastic strip. The stretching roller is fixed, closely positioned and generally tangent to the arc swung by the end of the pivoting oscillator frame, so that the adhesive backed elastic strip slips off the stretching roller and bonds to the poly as the poly moves tangent to the stretching roller. The stretch in the bonded elastic strip is then proportional to the difference between the tangential velocity of the stretching roller and the tangential velocity of the poly, so that alternations in stretch are induced by the variations in tangential velocity set by the cam profile. Optionally the cam profile has an enhanced velocity at the beginning of the changes in stretch, and the end of the oscillator frame is arc shaped and in continuous contact with the stretching roller, so that the change in velocity is quickly transferred to a change in the stretch of the bonded elastic strip. Satisfactory results, however, have been obtained with a simple roller on the end of the oscillator frame and a cam profile generating a velocity that alternates between two constant values. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic illustration of the preferred embodiment of the invention, including the relevant mathematical parameters which define its operation; FIG. 2 is a schematic illustration of an alternate embodiment of the invention which, with greater precision, provides transfer of the elastic strips from the stretching roller directly to the poly backing; FIG. 3 is an illustration of induced stretch as a function of velocity variations; and, FIG. 4 is a detailed diagrammatic illustration of the invention as employed in a diaper assembly line. DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention pertains to part of a machine for continuously assembling elastic leg disposable diapers. The machine sandwiches a highly absorbent material between a fluid permeable facing sheet and a fluid impervious poly backing sheet. The specific construction of the disposable diaper is the subject of a copending application titled "Disposable Diaper With Elasticised Leg Openings" by W. Sigl and R. Frick and assigned to the assignee of the present invention, but the present invention is equally applicable to other disposable diaper designs, including the design disclosed by Gore, U.S. Pat. No. 4,239,578 issued Dec. 16, 1980. The present invention involves the part of the diaper assembly machine that bonds elastic strips to the diaper material for elasticizing the leg openings of the finished diapers. Turning now to the drawings, FIG. 1 schematically shows the mechanism whereby differential stretch is imparted to an elastic strip 10 as it is bonded to poly backing sheet 18. The continuous elastic strip 10 is fed at a generally constant rate V 1 by a fixed stretching roller 12 rotated by shaft 14. The elastic strip slips off the stretching roller 12 at the tangent point 16 and is picked up by oscillator roller 20. Oscillator roller 20 is journaled for free rotation about shaft 22 secured to a movable oscillator frame 30. A continuous sheet of poly backing material 18 is also fed around oscillator roller 20, and receives the elastic at a tangent point 24. The poly with adhered elastic 28 is then pulled off the oscillator roller 20 for further processing in a diaper assembly line. Differential stretch is induced in the elastic strip 10 as it travels over distance X between the tangent points 16 and 24. The stretch S of the elastic 10 may be defined in terms of the linear density dX/dM of the elastic 10. With the units of the mass, M, chosen so that the linear density dX/dM of the unstretched elastic 10 is equal to 1, the elongation E is directly proportional to linear density: E=dX/dM=X/M (1) where M is the total mass of the elastic strip 10 between the tangent points 16 and 24. Since the process whereby the elastic 10 is carried or taken up by the rollers 12, 20 is a form of gear engagement, the elongation of the elastic 10 as it is bonded to the poly backing 18 is the same as the elongation of elastic strip 10 between the tangent points. The stretch S may also be defined in terms of the elongation E as: S=E-1 (2) The velocity V 1 of the elastic 10 as it travels around the stretching roller 12 is porportional to the radius and angular velocity of the stretching roller 12. Similarly the velocity V P of the poly backing 18 fed to the oscillator roller 20 is proportional to the radius and the angular velocity of the oscillator roller 20. The rate at which the elastic 10 between the tangent points 16, 24 is taken up by the oscillator roller 20 is defined as V 2 , which is FIG. 1 equals V p . V 1 and V 2 are functionally related to the elongation E and stretch S via the mass M of the elastic 10 by the conservation of mass equation: dM/dt=dM/dt in +dM/dt out =V.sub.1 -(M/X)V.sub.2 =V.sub.1 -(V.sub.2 /E) (3) In general, X is not independent of time, and is related to the velocity V s of the tangent point 24 of the oscillator roller 22 with respect to the tangent point 16 of the stretching roller 12: V.sub.s =dX/dt (4) In FIG. 1 V s =V a , the tangential velocity of the oscillator frame 30. Equations (1) through (4) supra completely define the stretch of the elastic strip bonded to the poly 28. The general solution, however, is non-linear. The solution for dE/dt=0 is of interest since then dX/dt=EdM/dt and therefore: for dE/dt=0, V.sub.s =EV.sub.1 =V.sub.2 (5) or equivalently for FIG. 1, V A =EV 1 -V p . By setting V p =1.5V 1 , for example, V A =-0.5 V 1 for E=1 and V a =+0.5 V 1 for E=2. The solution for V s =0 is also of interest since then equation (3) is linear and has the solutions: ##EQU1## Thus a time constant τ=X/V 2 defines the response of the elongation to changes in V 2 or V 1 . As shown in FIG. 3, if a velocity V which may be either V 1 , V 2 , or V p is switched between two values V L and V H as illustrated by the trapezoidal waveform generally designated 40, the response of the stretch S as illustrated by the waveform generally designated 50 has a triangular shape caused by a time delay measured by the time constant τ. In practice a stretch S that rapidly changes from a stretched to an unstretched condition is desirable. One method to obtain a rapid change is to reduce the time constant τ by decreasing the distance X. As shown in FIG. 2, the tangent point 16 of the elastic strip 10 with the stretching roller 12 may be made coincident with the tangent of contact 24 with the poly backing 18 by providing the oscillator frame 30 with an arcuate face plate 34 to press the poly backing in contact with the elastic 10 as the elastic slips off the stretching roller 12. Rollers 32 and 36 are provided at the ends of the face plate 34 and journaled to the oscillator frame 30 for free rotation to reduce the sliding friction of the poly backing 18 around the ends of the face plate 34. The geometry in FIG. 2 indicates that the velocity V 2 at which the elastic 10 is taken up by the poly 18 is the sum of the poly velocity V p and the tangential velocity V A of the oscillator frame 30. The geometry in FIG. 2 is more complicated than the geometry in FIG. 1 and thus it is desirable to find another way to reduce the delay in the response of the stretch S to changes in velocity V. Although the time constant τ is inversely proportional to V 2 , increasing V 2 does not help since the distance on the final diaper product over which the stretch is changing is the result to be minimized and this distance is defined by X and is independent of V 2 . The response of slew rate of the stretch S may, however, be increased by peaking either V 1 or V S while the stretch S is changing, as shown by the waveforms generally designated 60 and 70 in FIG. 3. The peaking 62 may be adjusted to obtain a desired rate of slew 72. Peaking of V S is easily obtained by varying the tangential velocity V A of the oscillator frame 30. Pursuant to the present invention and as shown in FIG. 4, variations in the tangential velocity V A are generated by the profile of an eccentric cam 102. A recessed track 107 in the cam 102 is provided to receive a cam follower 106 journaled via pin 110 to bracket 108 fastened to the oscillator frame 30. The oscillator frame 30 pivots about a shaft 100 affixed to the frame 90 of the diaper making machine. As cam 102 is rotated by a drive shaft 104 of the machine drive 92, the oscillator frame 30 is tangentially displaced periodically in an upward direction 138 and downward direction 140 through a displacement A. The maximum upward displacement 142 and downward displacement 144 are indicated by phantom lines. In the preferred embodiment, rollers 112 and 120 are journaled to the oscillator frame 30 by shafts 114 and 122 and are positioned about the pivot 100 along a line perpendicular to the longitudinal axis of the oscillator frame, thereby minimizing variations in the feed rate V P caused by variations in the tangential velocity V A of the oscillator frame 30. The elastic 10 is obtained from a spool 124 which may freely rotate around shaft 126 affixed to the machine frame 90 as the elastic is pulled by a preheat roll 126 driven by a drive shaft 128 of the machine drive 92. The elastic 10 passes around idler 130 journaled to shaft 132 affixed to the machine frame 90. The elastic then passes around a stretching chill roller 12 driven by a drive shaft 14 of the machine drive 92, and glue from a glue gun 134 is applied to the elastic 10 at point 136. The elastic 10 slips off the stretching chill roller 12 at tangent point 16. The elastic 10 and poly backing 18 are then both fed to the oscillator roller 20 which is journaled on shaft 22 fixed to the oscillator frame 30. The elastic 10, having differential stretch induced by displacement of the oscillator frame 30, bonds to the poly 18 at the tangent point 24 of the oscillator roller 20 and the poly and bonded elastic 28 are fed around idler roller 116 journaled on shaft 118 fixed to the oscillator frame 30. From idler roller 116 the poly and bonded elastic 28 pass around roller 120 and exit from the elastic bonding portion of the diaper assembly line. The preferred embodiment of FIG. 4 provides satisfactory differential stretch during the manufacture of diapers even without peaking of the oscillator frame 30 tangential velocity V A . Typically the feed rate of the poly backing V P is set about 1.5 times the feed rate of the elastic V 1 and a triangular displacement cam profile is used to switch the oscillator frame velocity V A between plus and minus one-half the elastic feed rate V 1 . Eighteen inch diapers, for example, may be manufactured using an arc displacement A of three inches, an oscillator frame velocity V A of plus and minus eight feet per minute, an elastic feed rate V 1 of sixteen feet per minute, and a poly feed rate V P of twenty-four feet per minute. The present disclosure includes that contained in the appended claims, as well as that of the foregoing description. Although this invention has been described in its preferred form with a certain degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of examples and that numerous changes in details of construction and the combination and arrangement of parts may be resorted to without departing from the spirit and scope of the invention as hereinafter claimed. In FIG. 4, for example, the elastic 10 is bonded to the poly backing 18, but in alternative diaper designs the elastic 10 could be bonded to the fluid permeable facing sheet by replacing the poly 18 with the fluid permeable facing sheet. Moreover, the adhesive could be applied to the poly backing 18 or fluid permeable sheet before bonding to the elastic 10 without substantially affecting the result. These are just a few of the modifications obvious to persons skilled in the art.

1a

RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Applications Ser. Nos. 61/542,392, filed Oct. 3, 2011, and 61/547,183, filed Oct. 14, 2011, the disclosures of which are incorporated by reference herein in their entirety. [0002] This application is related to PCT Application No. PCT/US2011/036215 filed May 12, 2011 (Attorney Docket No. 5470-549-WO). FIELD OF THE INVENTION [0003] The present invention concerns compounds, compositions and methods for the treatment of cancer. BACKGROUND OF THE INVENTION [0004] Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children and common varieties are cured by chemotherapy in 75%-85% of the cases. Collectively the less common T cell and rare B cell subsets represent less than 2000 cases yearly and thus can be classified as a rare disease; these subsets have a poorer prognosis. Unfortunately with either subset, resistance to and relapse from therapy is a major cause of pediatric cancer death. In addition, ALL chemotherapies can cause late complications that are increasingly recognized in pediatric survivor populations. In fact, in pediatric cancer survivors, the incidence of severe late effects (neurocognitive sequelae, auditory complications, cardiovascular dysfunction, gastrointestinal/hepatic dysfunction, growth delay, secondary malignancies, and infertility) directly related to therapy is approximately 25%. A better understanding of therapeutic resistance and its reversal could not only help those who relapse but may help lower the dose of chemotherapy needed in ALL patients thus reducing long-term toxicity for future survivors. SUMMARY OF THE INVENTION [0005] The ectopic expression of Mer receptor tyrosine kinase (Mer) has been identified as a tumor cell survival gene product in Acute Lymphoblastic Leukemia (ALL) cells and a potential cause of ALL chemoresistance. Hence, we investigated whether the development of small molecule Mer inhibitors was possible. [0006] A first aspect of the present invention is a compound (sometimes referred to as an “active compound” herein) of Formula I, IA, or IB: [0000] [0000] wherein: [0007] one of X and X′ is N and the other of X and X′ is C; [0008] one of the dashed lines in Formula I is a single bond and the other of the dashed lines is a double bond (e.g., as shown in Formulas IA and IB); [0009] R 1 is aryl; [0010] R 2 is —R 5 R 6 , where R 5 is a covalent bond or C1 to C3 alkyl and R 6 is cycloalkyl, heterocycloalkyl, aryl, heteroaryl or alkyl, and wherein R 6 is optionally substituted from one to two times with independently selected polar groups; [0011] R 3 is —NR 7 R 8 , where R 7 and R 8 are each independently selected from H, alkyl, arylalkyl; cycloalkylalkyl, heterocycloalkylalkyl, heteroaryalkyl, and alkoxyalkyl, each of which is optionally substituted one, two or three times with independently selected polar groups; [0012] or R 2 and R 3 together form a linking group; [0013] R 4 is H, loweralkyl, halo, or loweralkoxy; [0014] R 5 is H, loweralkyl, halo, or loweralkoxy; [0015] or a pharmaceutically acceptable salt or prodrug thereof. [0016] A further aspect of the invention is an active compound as described herein in a pharmaceutically acceptable carrier. [0017] A further aspect of the invention is a method of treating cancer in a subject in need thereof, comprising administering said subject an active compound as described herein in an amount effective to treat the cancer. [0018] A further aspect of the invention is an active compound as described herein for use in treating cancer, and/or for the preparation of a medicament for the treatment of cancer. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0019] “Deuterium” as used herein alone or as part of another group, refers to a safe, non-radioactive relative of hydrogen. Any hydrogen may be replaced with deuterium to modify/improve metabolic stability, resulting in better safety, tolerability and/or efficacy. [0020] “Alkyl” as used herein alone or as part of another group, refers to a straight or branched chain hydrocarbon containing from 1 to 10 carbon atoms. Representative examples of alkyl include, but are not limited to, methyl, ethyl, n-propyl, iso-propyl, n-butyl, sec-butyl, iso-butyl, tert-butyl, n-pentyl, isopentyl, neopentyl, n-hexyl, 3-methylhexyl, 2,2-dimethylpentyl, 2,3-dimethylpentyl, n-heptyl, n-octyl, n-nonyl, n-decyl, and the like. “Lower alkyl” as used herein, is a subset of alkyl, in some embodiments preferred, and refers to a straight or branched chain hydrocarbon group containing from 1 to 4 carbon atoms. Representative examples of lower alkyl include, but are not limited to, methyl, ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, tert-butyl, and the like. The term “alkyl” or “loweralkyl” is intended to include both substituted and unsubstituted alkyl or loweralkyl unless otherwise indicated and these groups may be substituted with groups selected from halo (e.g., haloalkyl), alkyl, haloalkyl, alkenyl, alkynyl, cycloalkyl, cycloalkylalkyl, aryl, arylalkyl, heterocyclo, heterocycloalkyl, hydroxyl, alkoxy (thereby creating a polyalkoxy such as polyethylene glycol), alkenyloxy, alkynyloxy, haloalkoxy, cycloalkoxy, cycloalkylalkyloxy, aryloxy, arylalkyloxy, heterocyclooxy, heterocyclolalkyloxy, mercapto, alkyl-S(O) m , haloalkyl-S(O) m , alkenyl-S(O) m , alkynyl-S(O) m , cycloalkyl-S(O) m , cycloalkylalkyl-S(O) m , aryl-S(O) m , arylalkyl-S(O) m , heterocyclo-S(O) m , heterocycloalkyl-S(O) m , amino, carboxy, alkylamino, alkenylamino, alkynylamino, haloalkylamino, cycloalkylamino, cycloalkylalkylamino, arylamino, arylalkylamino, heterocycloamino, heterocycloalkylamino, disubstituted-amino, acylamino, acyloxy, ester, amide, sulfonamide, urea, alkoxyacylamino, aminoacyloxy, nitro or cyano where m=0, 1, 2 or 3. [0021] “Alkenyl” as used herein alone or as part of another group, refers to a straight or branched chain hydrocarbon containing from 1 to 10 carbon atoms (or in loweralkenyl 1 to 4 carbon atoms) which include 1 to 4 double bonds in the normal chain. Representative examples of alkenyl include, but are not limited to, vinyl, 2-propenyl, 3-butenyl, 2-butenyl, 4-pentenyl, 3-pentenyl, 2-hexenyl, 3-hexenyl, 2,4-heptadiene, and the like. The term “alkenyl” or “loweralkenyl” is intended to include both substituted and unsubstituted alkenyl or loweralkenyl unless otherwise indicated and these groups may be substituted with groups as described in connection with alkyl and loweralkyl above. [0022] “Alkynyl” as used herein alone or as part of another group, refers to a straight or branched chain hydrocarbon containing from 1 to 10 carbon atoms (or in loweralkynyl 1 to 4 carbon atoms) which include 1 triple bond in the normal chain. Representative examples of alkynyl include, but are not limited to, 2-propynyl, 3-butynyl, 2-butynyl, 4-pentynyl, 3-pentynyl, and the like. The term “alkynyl” or “loweralkynyl” is intended to include both substituted and unsubstituted alkynyl or loweralkynyl unless otherwise indicated and these groups may be substituted with the same groups as set forth in connection with alkyl and loweralkyl above. [0023] “Cycloalkyl” as used herein alone or as part of another group, refers to a saturated or partially unsaturated cyclic hydrocarbon group containing from 3, 4 or 5 to 6, 7 or 8 carbons (which carbons may be replaced in a heterocyclic group as discussed below). Representative examples of cycloalkyl include, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, and cyclooctyl. These rings may be optionally substituted with additional substituents as described herein such as halo or loweralkyl. The term “cycloalkyl” is generic and intended to include heterocyclic groups as discussed below unless specified otherwise. [0024] “Heterocyclic group” or “heterocyclo” as used herein alone or as part of another group, refers to an aliphatic (e.g., fully or partially saturated heterocyclo) or aromatic (e.g., heteroaryl) monocyclic- or a bicyclic-ring system. Monocyclic ring systems are exemplified by any 5 or 6 membered ring containing 1, 2, 3, or 4 heteroatoms independently selected from oxygen, nitrogen and sulfur. The 5 membered ring has from 0-2 double bonds and the 6 membered ring has from 0-3 double bonds. Representative examples of monocyclic ring systems include, but are not limited to, azetidine, azepine, aziridine, diazepine, 1,3-dioxolane, dioxane, dithiane, furan, imidazole, imidazoline, imidazolidine, isothiazole, isothiazoline, isothiazolidine, isoxazole, isoxazoline, isoxazolidine, morpholine, oxadiazole, oxadiazoline, oxadiazolidine, oxazole, oxazoline, oxazolidine, piperazine, piperidine, pyran, pyrazine, pyrazole, pyrazoline, pyrazolidine, pyridine, pyrimidine, pyridazine, pyrrole, pyrroline, pyrrolidine, tetrahydrofuran, tetrahydrothiophene, tetrazine, tetrazole, thiadiazole, thiadiazoline, thiadiazolidine, thiazole, thiazoline, thiazolidine, thiophene, thiomorpholine, thiomorpholine sulfone, thiopyran, triazine, triazole, trithiane, and the like. Bicyclic ring systems are exemplified by any of the above monocyclic ring systems fused to an aryl group as defined herein, a cycloalkyl group as defined herein, or another monocyclic ring system as defined herein. Representative examples of bicyclic ring systems include but are not limited to, for example, benzimidazole, benzothiazole, benzothiadiazole, benzothiophene, benzoxadiazole, benzoxazole, benzofuran, benzopyran, benzothiopyran, benzodioxine, 1,3-benzodioxole, cinnoline, indazole, indole, indoline, indolizine, naphthyridine, isobenzofuran, isobenzothiophene, isoindole, isoindoline, isoquinoline, phthalazine, purine, pyranopyridine, quinoline, quinolizine, quinoxaline, quinazoline, tetrahydroisoquinoline, tetrahydroquinoline, thiopyranopyridine, and the like. These rings include quaternized derivatives thereof and may be optionally substituted with groups selected from halo, alkyl, haloalkyl, alkenyl, alkynyl, cycloalkyl, cycloalkylalkyl, aryl, arylalkyl, heterocyclo, heterocycloalkyl, hydroxyl, alkoxy, alkenyloxy, alkynyloxy, haloalkoxy, cycloalkoxy, cycloalkylalkyloxy, aryloxy, arylalkyloxy, heterocyclooxy, heterocyclolalkyloxy, mercapto, alkenyl-S(O) m , haloalkyl-S(O) m , alkenyl-S(O) m , alkynyl-S(O) m , cycloalkyl-S(O) m , cycloalkylalkyl-S(O) m , aryl-S(O) m , arylalkyl-S(O) m , heterocyclo-S(O) m , heterocycloalkyl-S(O) m , amino, alkylamino, alkenylamino, alkynylamino, haloalkylamino, cycloalkylamino, cycloalkylalkylamino, arylamino, arylalkylamino, heterocycloamino, heterocycloalkylamino, disubstituted-amino, acylamino, acyloxy, ester, amide, sulfonamide, urea, alkoxyacylamino, aminoacyloxy, nitro or cyano where m=0, 1, 2 or 3. [0025] “Aryl” as used herein alone or as part of another group, refers to a monocyclic carbocyclic ring system or a bicyclic carbocyclic fused ring system having one or more aromatic rings. Representative examples of aryl include, azulenyl, indanyl, indenyl, naphthyl, phenyl, tetrahydronaphthyl, and the like. The term “aryl” is intended to include both substituted and unsubstituted aryl unless otherwise indicated and these groups may be substituted with the same groups as set forth in connection with alkyl and loweralkyl above. [0026] “Arylalkyl” as used herein alone or as part of another group, refers to an aryl group, as defined herein, appended to the parent molecular moiety through an alkyl group, as defined herein. Representative examples of arylalkyl include, but are not limited to, benzyl, 2-phenylethyl, 3-phenylpropyl, 2-naphth-2-ylethyl, and the like. [0027] “Heteroaryl” as used herein is as described in connection with heterocyclo above. [0028] “Alkoxy” as used herein alone or as part of another group, refers to an alkyl or loweralkyl group, as defined herein (and thus including substituted versions such as polyalkoxy), appended to the parent molecular moiety through an oxy group, —O—. Representative examples of alkoxy include, but are not limited to, methoxy, ethoxy, propoxy, 2-propoxy, butoxy, tert-butoxy, pentyloxy, hexyloxy and the like. [0029] “Halo” as used herein refers to any suitable halogen, including —F, —Cl, —Br, and —I. [0030] “Mercapto” as used herein refers to an —SH group. [0031] “Azido” as used herein refers to an —N 3 group. [0032] “Cyano” as used herein refers to a —CN group. [0033] “Formyl” as used herein refers to a —C(O)H group. [0034] “Carboxylic acid” as used herein refers to a —C(O)OH group. [0035] “Hydroxyl” as used herein refers to an —OH group. [0036] “Nitro” as used herein refers to an —NO 2 group. [0037] “Acyl” as used herein alone or as part of another group refers to a —C(O)R radical, where R is any suitable substituent such as aryl, alkyl, alkenyl, alkynyl, cycloalkyl or other suitable substituent as described herein. [0038] “Alkylthio” as used herein alone or as part of another group, refers to an alkyl group, as defined herein, appended to the parent molecular moiety through a thio moiety, as defined herein. Representative examples of alkylthio include, but are not limited, methylthio, ethylthio, tert-butylthio, hexylthio, and the like. [0039] “Amino” as used herein means the radical —NH 2 . [0040] “Alkylamino” as used herein alone or as part of another group means the radical —NHR, where R is an alkyl group. [0041] “Arylalkylamino” as used herein alone or as part of another group means the radical —NHR, where R is an arylalkyl group. [0042] “Disubstituted-amino” as used herein alone or as part of another group means the radical —NR a R b , where R a and R b are independently selected from the groups alkyl, haloalkyl, alkenyl, alkynyl, cycloalkyl, cycloalkylalkyl, aryl, arylalkyl, heterocyclo, heterocycloalkyl. [0043] “Acylamino” as used herein alone or as part of another group means the radical —NR a R b , where R a is an acyl group as defined herein and R b is selected from the groups hydrogen, alkyl, haloalkyl, alkenyl, alkynyl, cycloalkyl, cycloalkylalkyl, aryl, arylalkyl, heterocyclo, heterocycloalkyl. [0044] “Acyloxy” as used herein alone or as part of another group means the radical —OR, where R is an acyl group as defined herein. [0045] “Ester” as used herein alone or as part of another group refers to a —C(O)OR radical, where R is any suitable substituent such as alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0046] “Amide” as used herein alone or as part of another group refers to a —C(O)NR a R b radical, where R a and R b are any suitable substituent such as alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0047] “Sulfoxyl” as used herein refers to a compound of the formula —S(O)R, where R is any suitable substituent such as alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0048] “Sulfonyl” as used herein refers to a compound of the formula —S(O)(O)R, where R is any suitable substituent such as amino, alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0049] “Sulfonate” as used herein refers to a compound of the formula —S(O)(O)OR, where R is any suitable substituent such as alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0050] “Sulfonic acid” as used herein refers to a compound of the formula —S(O)(O)OH. [0051] “Sulfonamide” as used herein alone or as part of another group refers to a —S(O) 2 NR a R b radical, where R a and R b are any suitable substituent such as H, alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0052] “Urea” as used herein alone or as part of another group refers to an N(R c )C(O)NR a R b radical, where R a , R b and R c are any suitable substituent such as H, alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0053] “Alkoxyacylamino” as used herein alone or as part of another group refers to an —N(R a )C(O)OR b radical, where R a , R b are any suitable substituent such as H, alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0054] “Aminoacyloxy” as used herein alone or as part of another group refers to an —OC(O)NR a R b radical, where R a and R b are any suitable substituent such as H, alkyl, cycloalkyl, alkenyl, alkynyl or aryl. [0055] “Polar group” as used herein refers to a group wherein the nuclei of the atoms covalently bound to each other to form the group do not share the electrons of the covalent bond(s) joining them equally; that is the electron cloud is denser about one atom than another. This results in one end of the covalent bond(s) being relatively negative and the other end relatively positive; i.e., there is a negative pole and a positive pole. Examples of polar groups include, without limitations, halo, hydroxy, alkoxy, carboxy, nitro, cyano, amino (primary, secondary and tertiary), amido, ureido, sulfonamido, sulfinyl, sulfhydryl, silyl, S-sulfonamido, N-sulfonamido, C-carboxy, O-carboxy, C-amido, N-amido, sulfonyl, N-tert-butoxycarbonyl (or “t-BOC”) groups, phosphono, morpholino, piperazinyl, tetrazolo, and the LO like. See, e.g., U.S. Pat. No. 6,878,733, as well as alcohol, thiol, polyethylene glycol, polyol (including sugar, aminosugar, uronic acid), sulfonamide, carboxamide, hydrazide, N-hydroxycarboxamide, urea, metal chelates (including macrocyclic ligand or crown ether metal chelates). The polar group can be an ionic group. [0056] “Ionic group” as used herein includes anionic and cationic groups, and includes groups (sometimes referred to as “ionogenic” groups) that are uncharged in one form but can be easily converted to ionic groups (for example, by protonation or deprotonation in aqueous solution). Examples include but are not limited to carboxylate, sulfonate, phosphate, amine, N-oxide, and ammonium (including quaternized heterocyclic amines such as imidazolium and pyridinium) groups. See, e.g., U.S. Pat. Nos. 6,478,863; 6,800,276; and 6,896,246. Additional examples include uronic acids, carboxylic acid, sulfonic acid, amine, and moieties such as guanidinium, phosphoric acid, phosphonic acid, phosphatidyl choline, phosphonium, borate, sulfate, etc. [0057] “Linking group” as used herein are generally bivalent aromatic, aliphatic, or mixed aromatic and aliphatic groups. Thus linking groups include linear or branched, substituted or unsubstituted aryl, alkyl, alkylaryl, or alkylarylalkyl linking groups, where the alkyl groups are saturated or unsaturated, and where the alkyl and aryl groups optionally containing independently selected heteroatoms such as 1, 2, 3 or 4 heteroatoms selected from the group consisting of N, O, and S. In some embodiments, linking groups containing from 2 to 20 carbon atoms are preferred. Numerous examples of suitable linking groups are known, including but not limited to those described in, U.S. Pat. Nos. 8,247,572; 8,097,609; 6,624,317; 6,613,345; 6,596,935; and 6,420,377, the disclosures of which are incorporated by reference herein in their entirety. [0058] “Treat” as used herein refers to any type of treatment that imparts a benefit to a patient afflicted with a disease, including improvement in the condition of the patient (e.g., in one or more symptoms), delay in the progression of the disease, delay in onset of the disease, etc. [0059] “Pharmaceutically acceptable” as used herein means that the compound or composition is suitable for administration to a subject to achieve the treatments described herein, without unduly deleterious side effects in light of the severity of the disease and necessity of the treatment. [0060] Active compounds of the present invention may optionally be administered in conjunction with other compounds useful in the treatment of cancer. The other compounds may optionally be administered concurrently. As used herein, the word “concurrently” means sufficiently close in time to produce a combined effect (that is, concurrently may be simultaneously, or it may be two or more events occurring within a short time period before or after each other). [0061] The present invention is primarily concerned with the treatment of human subjects, but the invention may also be carried out on animal subjects, particularly mammalian subjects such as mice, rats, dogs, cats, livestock and horses for veterinary purposes, and for drug screening and drug development purposes. Subjects may be of any age, including infant, juvenile, adolescent, adult, and geriatric subjects. 1. Active Compounds. [0062] As noted above, the present invention provides active compounds of Formula I, IA, or IB: [0000] [0000] wherein: [0063] one of X and X′ is N and the other of X and X′ is C; [0064] one of the dashed lines is a single bond (between a ring carbon atom and a ring nitrogen atom) and the other of the dashed lines is a double bond (between two ring carbon atoms); [0065] R 1 is aryl; [0066] R 2 is —R 5 R 6 , where R 5 is a covalent bond or C1 to C3 alkyl and R 6 is cycloalkyl, heterocycloalkyl, aryl, heteroaryl or alkyl, and wherein R 6 is optionally substituted from one to two times with independently selected polar groups; [0067] R 3 is —NR 7 R 8 , where R 7 and R 8 are each independently selected from H, alkyl, arylalkyl; cycloalkylalkyl, heterocycloalkylalkyl, heteroaryalkyl, and alkoxyalkyl, each of which is optionally substituted one, two or three times with independently selected polar groups; and [0068] R 4 is H, loweralkyl, halo, or loweralkoxy; [0069] or a pharmaceutically acceptable salt or prodrug thereof. [0070] In some embodiments of the foregoing, R 1 is phenyl or pyridyl, which phenyl or pyridyl is unsubstituted or substituted from 1 to 3 times with halo, amino, nitro, alkyl, alkoxyl, haloalkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl. [0071] In some embodiments of the foregoing R 5 is —CH 2 —. [0072] In some embodiments of the foregoing, R 8 is C1-C8 alkyl, C3-C8 cycloalkyl, or C1-C8 alkyl aryl. [0073] In some embodiments of the foregoing, R 6 is cyclohexyl. [0074] In some embodiments of the foregoing, R 6 is substituted once with amino. [0075] In some embodiments of the foregoing, R 7 is H. [0076] In some embodiments of the foregoing, R 8 is loweralkyl. [0077] In some embodiments of the foregoing, R 4 is H. [0078] Particular examples of compounds of the present invention include but are not limited to those set forth in Table 1 and Example 2 below. [0079] Active compounds may be provided as pharmaceutically acceptable prodrugs, which are those prodrugs of the active compounds of the present invention which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of humans and lower animals without undue toxicity, irritation, allergic response and the like, commensurate with a reasonable risk/benefit ratio, and effective for their intended use, as well as the zwitterionic forms, where possible, of the compounds of the invention. The term “prodrug” refers to compounds that are rapidly transformed in vivo to yield the parent compound of the above formulae, for example, by hydrolysis in blood. A thorough discussion is provided in T. Higuchi and V. Stella, Prodrugs as Novel delivery Systems, Vol. 14 of the A.C.S. Symposium Series and in Edward B. Roche, ed., Bioreversible Carriers in Drug Design, American Pharmaceutical Association and Pergamon Press, 1987, both of which are incorporated by reference herein. See also U.S. Pat. No. 6,680,299 Examples include a prodrug that is metabolized in vivo by a subject to an active drug having an activity of active compounds as described herein, wherein the prodrug is an ester of an alcohol or carboxylic acid group, if such a group is present in the compound; an acetal or ketal of an alcohol group, if such a group is present in the compound; an N-Mannich base or an imine of an amine group, if such a group is present in the compound; or a Schiff base, oxime, acetal, enol ester, oxazolidine, or thiazolidine of a carbonyl group, if such a group is present in the compound, such as described in U.S. Pat. No. 6,680,324 and U.S. Pat. No. 6,680,322. [0080] The active compounds disclosed herein can, as noted above, be provided in the form of their pharmaceutically acceptable salts. Pharmaceutically acceptable salts are salts that retain the desired biological activity of the parent compound and do not impart undesired toxicological effects. Examples of such salts are (a) acid addition salts formed with inorganic acids, for example hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, nitric acid and the like; and salts formed with organic acids such as, for example, acetic acid, oxalic acid, tartaric acid, succinic acid, maleic acid, fumaric acid, gluconic acid, citric acid, malic acid, ascorbic acid, benzoic acid, tannic acid, palmitic acid, alginic acid, polyglutamic acid, naphthalenesulfonic acid, methanesulfonic acid, p-toluenesulfonic acid, naphthalenedisulfonic acid, polygalacturonic acid, and the like; (b) salts formed from elemental anions such as chlorine, bromine, and iodine, and (c) salts derived from bases, such as ammonium salts, alkali metal salts such as those of sodium and potassium, alkaline earth metal salts such as those of calcium and magnesium, and salts with organic bases such as dicyclohexylamine and N-methyl-D-glucamine. [0081] Active compounds as described herein can be prepared in accordance with known procedures, or variations thereof that will be apparent to those skilled in the art. 2. Pharmaceutical Formulations. [0082] The active compounds described above may be formulated for administration in a pharmaceutical carrier in accordance with known techniques. See, e.g., Remington, The Science And Practice of Pharmacy (9 th Ed. 1995). In the manufacture of a pharmaceutical formulation according to the invention, the active compound (including the physiologically acceptable salts thereof) is typically admixed with, inter alia, an acceptable carrier. The carrier must, of course, be acceptable in the sense of being compatible with any other ingredients in the formulation and must not be deleterious to the patient. The carrier may be a solid or a liquid, or both, and is preferably formulated with the compound as a unit-dose formulation, for example, a tablet, which may contain from 0.01 or 0.5% to 95% or 99% by weight of the active compound. One or more active compounds may be incorporated in the formulations of the invention, which may be prepared by any of the well known techniques of pharmacy comprising admixing the components, optionally including one or more accessory ingredients. [0083] The formulations of the invention include those suitable for oral, rectal, topical, buccal (e.g., sub-lingual), vaginal, parenteral (e.g., subcutaneous, intramuscular, intradermal, or intravenous), topical (i.e., both skin and mucosal surfaces, including airway surfaces), transdermal administration, and intraventricular injection (injection into a ventricle of the brain, e.g., by an implanted catheter or omman reservoir, such as in the case of morbid obesity) and although the most suitable route in any given case will depend on the nature and severity of the condition being treated and on the nature of the particular active compound which is being used. [0084] Formulations suitable for oral administration may be presented in discrete units, such as capsules, cachets, lozenges, or tablets, each containing a predetermined amount of the active compound; as a powder or granules; as a solution or a suspension in an aqueous or non-aqueous liquid; or as an oil-in-water or water-in-oil emulsion. Such formulations may be prepared by any suitable method of pharmacy which includes the step of bringing into association the active compound and a suitable carrier (which may contain one or more accessory ingredients as noted above). In general, the formulations of the invention are prepared by uniformly and intimately admixing the active compound with a liquid or finely divided solid carrier, or both, and then, if necessary, shaping the resulting mixture. For example, a tablet may be prepared by compressing or molding a powder or granules containing the active compound, optionally with one or more accessory ingredients. Compressed tablets may be prepared by compressing, in a suitable machine, the compound in a free-flowing form, such as a powder or granules optionally mixed with a binder, lubricant, inert diluent, and/or surface active/dispersing agent(s). Molded tablets may be made by molding, in a suitable machine, the powdered compound moistened with an inert liquid binder. [0085] Formulations suitable for buccal (sub-lingual) administration include lozenges comprising the active compound in a flavoured base, usually sucrose and acacia or tragacanth; and pastilles comprising the compound in an inert base such as gelatin and glycerin or sucrose and acacia. [0086] Formulations of the present invention suitable for parenteral administration comprise sterile aqueous and non-aqueous injection solutions of the active compound, which preparations are preferably isotonic with the blood of the intended recipient. These preparations may contain anti-oxidants, buffers, bacteriostats and solutes which render the formulation isotonic with the blood of the intended recipient. Aqueous and non-aqueous sterile suspensions may include suspending agents and thickening agents. The formulations may be presented in unit\dose or multi-dose containers, for example sealed ampoules and vials, and may be stored in a freeze-dried (lyophilized) condition requiring only the addition of the sterile liquid carrier, for example, saline or water-for-injection immediately prior to use. Extemporaneous injection solutions and suspensions may be prepared from sterile powders, granules and tablets of the kind previously described. For example, in one aspect of the present invention, there is provided an injectable, stable, sterile composition comprising a compound of Formula (I), or a salt thereof, in a unit dosage form in a sealed container. The compound or salt is provided in the form of a lyophilizate which is capable of being reconstituted with a suitable pharmaceutically acceptable carrier to form a liquid composition suitable for injection thereof into a subject. The unit dosage form typically comprises from about 10 mg to about 10 grams of the compound or salt. When the compound or salt is substantially water-insoluble, a sufficient amount of emulsifying agent which is physiologically acceptable may be employed in sufficient quantity to emulsify the compound or salt in an aqueous carrier. One such useful emulsifying agent is phosphatidyl choline. [0087] Formulations suitable for rectal administration are preferably presented as unit dose suppositories. These may be prepared by admixing the active compound with one or more conventional solid carriers, for example, cocoa butter, and then shaping the resulting mixture. [0088] Formulations suitable for topical application to the skin preferably take the form of an ointment, cream, lotion, paste, gel, spray, aerosol, or oil. Carriers which may be used include petroleum jelly, lanoline, polyethylene glycols, alcohols, transdermal enhancers, and combinations of two or more thereof. [0089] Formulations suitable for transdermal administration may be presented as discrete patches adapted to remain in intimate contact with the epidermis of the recipient for a prolonged period of time. Formulations suitable for transdermal administration may also be delivered by iontophoresis (see, for example, Pharmaceutical Research 3 (6):318 (1986)) and typically take the form of an optionally buffered aqueous solution of the active compound. Suitable formulations comprise citrate or bis\tris buffer (pH 6) or ethanol/water and contain from 0.1 to 0.2M active ingredient. [0090] Further, the present invention provides liposomal formulations of the compounds disclosed herein and salts thereof. The technology for forming liposomal suspensions is well known in the art. When the compound or salt thereof is an aqueous-soluble salt, using conventional liposome technology, the same may be incorporated into lipid vesicles. In such an instance, due to the water solubility of the compound or salt, the compound or salt will be substantially entrained within the hydrophilic center or core of the liposomes. The lipid layer employed may be of any conventional composition and may either contain cholesterol or may be cholesterol-free. When the compound or salt of interest is water-insoluble, again employing conventional liposome formation technology, the salt may be substantially entrained within the hydrophobic lipid bilayer which forms the structure of the liposome. In either instance, the liposomes which are produced may be reduced in size, as through the use of standard sonication and homogenization techniques. [0091] Of course, the liposomal formulations containing the compounds disclosed herein or salts thereof, may be lyophilized to produce a lyophilizate which may be reconstituted with a pharmaceutically acceptable carrier, such as water, to regenerate a liposomal suspension. [0092] Other pharmaceutical compositions may be prepared from the water-insoluble compounds disclosed herein, or salts thereof, such as aqueous base emulsions. In such an instance, the composition will contain a sufficient amount of pharmaceutically acceptable emulsifying agent to emulsify the desired amount of the compound or salt thereof. Particularly useful emulsifying agents include phosphatidyl cholines, and lecithin. [0093] In addition to compounds of formula (I) or their salts, the pharmaceutical compositions may contain other additives, such as pH-adjusting additives. In particular, useful pH-adjusting agents include acids, such as hydrochloric acid, bases or buffers, such as sodium lactate, sodium acetate, sodium phosphate, sodium citrate, sodium borate, or sodium gluconate. Further, the compositions may contain microbial preservatives. Useful microbial preservatives include methylparaben, propylparaben, and benzyl alcohol. The microbial preservative is typically employed when the formulation is placed in a vial designed for multidose use. Of course, as indicated, the pharmaceutical compositions of the present invention may be lyophilized using techniques well known in the art. 3. Dosage and Routes of Administration. [0094] As noted above, the present invention provides pharmaceutical formulations comprising the active compounds (including the pharmaceutically acceptable salts thereof), in pharmaceutically acceptable carriers for oral, rectal, topical, buccal, parenteral, intramuscular, intradermal, or intravenous, and transdermal administration. [0095] The therapeutically effective dosage of any specific compound, the use of which is in the scope of present invention, will vary somewhat from compound to compound, and patient to patient, and will depend upon the condition of the patient and the route of delivery. As a general proposition, a dosage from about 0.1 to about 50 mg/kg will have therapeutic efficacy, with all weights being calculated based upon the weight of the active compound, including the cases where a salt is employed. Toxicity concerns at the higher level may restrict intravenous dosages to a lower level such as up to about 10 mg/kg, with all weights being calculated based upon the weight of the active base, including the cases where a salt is employed. A dosage from about 10 mg/kg to about 50 mg/kg may be employed for oral administration. In some embodiments, a dosage from about 0.5 mg/kg to 5 mg/kg may be employed for intramuscular injection. In some embodiments, dosages are 1 μmol/kg to 50 μmol/kg, and more preferably 22 μmol/kg and 33 μmol/kg of the compound for intravenous or oral administration. The duration of the treatment can be once per day for a period of two to three weeks or until the condition is essentially controlled. [0096] As noted above, the active compounds described herein are useful for the treatment of cancer. Example cancers that may be treated by the compounds and methods of the invention include, but are not limited to, myeloid leukemia, lymphoblastic leukemia, melanoma, breast, lung, colon, liver, gastric, kidney, ovarian, uterine, and brain cancer. [0097] The present invention is explained in greater detail in the following non-limiting Examples. Example 1 7-((Trans-4-aminocyclohexyl)methyl)-N-butyl-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine General Procedure A: [0098] tert-Butyl trans-4-((5-bromo-2-(butylamino)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)methyl)cyclohexylcarbamate [0099] [0100] A 10 mL microwave tube was charged with 5-bromo-2-chloro-7H-pyrrolo[2,3-d]pyrimidine (0.23 g, 1.0 mmol), tert-butyl trans-4-(iodomethyl)cyclohexylcarbamate (0.51 g, 1.5 mmol), K 2 CO 3 (0.28 g, 2.0 mmol), DMSO (1.5 mL) and THF (3 mL). The mixture was heated at 150° C. for 100 min in microwave. After the reaction mixture was cooled to ambient temperature, n-butylamine (0.18 g, 2.5 mmol) was added. The mixture was heated at 150° C. for 90 min in microwave. After cooling to ambient temperature, the reaction was poured into water and extracted with EtOAc (3×). The combined organic layer was dried (Na 2 SO 4 ) and concentrated. The crude mixture was purified by Isco to provide tert-butyl trans-4-((5-bromo-2-(butylamino)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)methyl)cyclohexylcarbamate (0.35 g, 73%) as a white solid. MS m/z 480.2 [M+H] + . 7-((Trans-4-aminocyclohexyl)methyl)-N-butyl-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine [0101] [0102] A 10 mL microwave tube was charged with tert-butyl trans-4-((5-bromo-2-(butylamino)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)methyl)cyclohexylcarbamate (0.096 g, 0.20 mmol), 4-fluorophenylboronic acid (0.042 g, 0.30 mmol), potassium carbonate (0.055 g, 0.40 mmol), tetrakis(triphenylphosphine)palladium (0.024 g, 0.020 mmol), dioxane (2 mL) and water (0.50 mL). The reaction was heat at 120° C. for 10 min in microwave. The reaction was diluted with EtOAc and washed with water. The aqueous layer was extracted with EtOAc (3×). The combined organic layers were dried (Na 2 SO 4 ), concentrated, and purified by Isco to provide tert-butyl trans-4-((2-(butylamino)-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)methyl)cyclohexylcarbamate. This intermediate was dissolved in CH 2 Cl 2 (2 mL). Trifluoroacetic acid (0.6 mL) was added at ambient temperature. After stirring for 2 h, the solvent was evaporated. The residue was purified by preparative HPLC to provide 7-((trans-4-aminocyclohexyl)methyl)-N-butyl-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine (UNC1537A) as a yellow solid (TFA salt) (UNC1537A) (0.032 g, 41%). 1 H NMR (400 MHz, CD 3 OD) δ 8.76 (s, 1H), 7.67 (s, 1H), 7.67-7.61 (m, 2H), 7.21 (t, J=8.5 Hz, 2H), 4.10 (d, J=7.0 Hz, 2H), 3.54 (t, J=7.1 Hz, 2H), 3.16-3.01 (m, 1H), 2.07 (d, J=10.3 Hz, 2H), 2.04-1.92 (m, 1H), 1.85 (d, J=12.2 Hz, 2H), 1.76-1.65 (m, 2H), 1.54-1.44 (m, 2H), 1.44-1.34 (m, 2H), 1.34-1.20 (m, 2H), 1.01 (t, J=7.4 Hz, 3H); MS m/z 396.3 [M+H] + . [0000] Table 1 describes compounds prepared following procedures described in Example 1 (General Procedure A), using appropriate reagents. Physical Data Mer MS m/z (M + 1) or/and 1 H Structure Compound_ID IC 50 NMR (400 MHz, CD 3 OD) 1 UNC1532A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.73 (s, 1H), 7.59 (s, 1H), 7.56 (d, J = 8.7 Hz, 2H), 7.16-7.07 (m, 2H), 4.09 (d, J = 7.0 Hz, 2H), 3.92-3.83 (m, 4H), 3.54 (t, J = 7.1 Hz, 2H), 3.28-3.21 (m, 4H), 3.14-3.02 (m, 1H), 2.07 (d, J = 10.0 Hz, 2H), 2.03-1.92 (m, 1H), 1.84 (d, J = 11.9 Hz, 2H), 1.75- 1.65 (m, 2H), 1.55-1.44 (m, 2H), 1.44-1.34 (m, 2H), 1.34-1.21 (m, 2H), 1.01 (t, J = 7.4 Hz, 3H); MS m/z 463.3 [M + 1] + . 2 UNC1533A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.74 (s, 1H), 7.60 (s, 1H), 7.58 (d, J = 8.8 Hz, 2H), 7.13 (d, J = 8.8 Hz, 2H), 4.09 (d, J = 7.0 Hz, 2H), 3.54 (t, J = 7.1 Hz, 2H), 3.51-3.44 (m, 4H), 3.43-3.37 (m, 4H), 3.13-3.02 (m, 1H), 2.07 (d, J = 9.9 Hz, 2H), 2.03-1.94 (m, 1H), 1.84 (d, J = 12.3 Hz, 2H), 1.76- 1.65 (m, 2H), 1.54-1.44 (m, 2H), 1.44-1.34 (m, 2H), 1.34- 1.20 (m, 2H), 1.01 (t, J = 7.4 Hz, 3H); MS m/z 462.3 [M + 1] + . 3 UNC1534A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.90 (s, 1H), 7.98-7.85 (m, 5H), 4.14 (d, J = 7.0 Hz, 2H), 4.08-3.72 (bs, 2H), 3.69-3.42 (bs, 2H), 3.56 (t, J = 7.1 Hz, 2H), 3.31-3.15 (bs, 2H), 3.15-3.01 (m, 1H), 2.90 (s, 3H), 2.89-2.59 (bs, 2H), 2.08 (d, J = 10.0 Hz, 2H), 2.04- 1.94 (m, 1H), 1.85 (d, J = 12.0 Hz, 2H), 1.77-1.66 (m, 2H), 1.55-1.45 (m, 2H), 1.45- 1.35 (m, 2H), 1.35-1.21 (m, 2H), 1.02 (t, J = 7.4 Hz, 3H); MS m/z 540.3 [M + 1] + . 4 UNC1535A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.86 (s, 1H), 7.98 (d, J = 8.5 Hz, 2H), 7.86 (s, 1H), 7.83 (d, J = 8.5 Hz, 2H), 4.12 (d, J = 7.0 Hz, 2H), 3.54 (t, J = 7.1 Hz, 2H), 3.16-3.01 (m, 1H), 2.08 (d, J = 10.3 Hz, 2H), 2.04-1.93 (m, 1H), 1.85 (d, J = 12.0 Hz, 2H), 1.77-1.65 (m, 2H), 1.55-1.44 (m, 2H), 1.43- 1.34 (m, 2H), 1.34-1.20 (m, 2H), 1.01 (t, J = 7.4 Hz, 3H); MS m/z 457.3 [M + 1] + . 5 UNC1536A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.92 (s, 1H), 7,98 (s, 1H), 7.83 (t, J = 7.9 Hz, 1H), 7.68- 7.65 (m, 1H), 7.64 (s, 1H), 4.12 (d, J = 7.0 Hz, 2H), 3.76-3.65 (m, 4H), 3.55 (t, J = 7.1 Hz, 2H), 3.20-3.11 (m, 4H), 3.11-3.02 (m, 1H), 2.07 (d, J = 10.5 Hz, 2H), 2.04- 1.94 (m, 1H), 1.86 (d, J = 11.9 Hz, 2H), 1.76-1.65 (m, 2H), 1.55-1.44 (m, 2H), 1.44- 1.35 (m, 2H), 1.34-1.21 (m, 2H), 1.01 (t, J = 7.4 Hz, 3H); MS m/z 545.3 [M + 1] + . (Note: Mer IC50: ++++ means <10 nM; +++ means between 10-100 nM, ++ means between 100 nM-1 μM; + means between 1-30 μM; − means inactive.) Example 2 Trans-4-(2-(Butylamino)-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)cyclohexanol General Procedure B: [0103] 5-Bromo-7-(trans-4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-2-chloro-7H-pyrrolo[2,3-d]pyrimidine [0104] [0105] To a suspension of 5-bromo-2-chloro-7H-pyrrolo[2,3-d]pyrimidine (0.13 g, 0.50 mmol) and cis-4-(tert-butyldimethylsilyloxy)cyclohexanol (0.23 g, 1.0 mmol) in toluene (8 mL) was added (cyanomethylene)trimethylphosphorane (CMMP; prepared according to Chem. Pharm. Bull. 2003, 51(4), 474-476.) (6.3 mL, 0.16 M in THF, 1.0 mmol). The resulting clear solution was refluxed for 16 h. The reaction mixture was washed with brine, and extracted with EtOAc (3×). The combined organic layer was dried (Na 2 SO 4 ) and concentrated. The residue was purified on ISCO to provide the desired product (0.16 g, 72%). 1H NMR (400 MHz, CD 3 OD) δ 8.71 (s, 1H), 7.27 (s, 1H), 4.70 (tt, J=12.2, 3.9 Hz, 1H), 3.69 (tt, J=10.5, 4.2 Hz, 1H), 2.09-1.99 (m, 3H), 1.86-1.71 (m, 2H), 1.66-1.54 (m, 3H), 0.90 (s, 9H), 0.08 (s, 6H). MS m/z 444.2 [M+H] + . Trans-4-(2-(butylamino)-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)cyclohexanol [0106] [0107] To a solution of 5-bromo-7-(trans-4-(tert-butyldimethylsilyloxy)cyclohexyl)-2-chloro-7H-pyrrolo[2,3-d]pyrimidine (0.082 g, 0.18 mmol) in isopropyl alcohol (2.0 mL) was added n-butylamine (0.033 g, 0.45 mmol) in a microwave tube. The resulting mixture was heated under microwave irradiation at 150° C. for 1.5 h. After the reaction cooled to room temperature, the solvent and excess amine was evaporated under vacuum. The residue was dissolved in THF and concentrated under vacuum (3×). Then it was dissolved in THF (2.0 mL) in a microwave tube. To this solution was added K 2 CO 3 (0.050 g, 0.36 mmol), Pd(PPh 3 ) 4 (0.021 g, 0.018 mmol), (4-fluorophenyl)boronic acid (0.038 g, 0.27 mmol), and H 2 O (0.5 mL). The resulting mixture was heated under microwave irradiation at 150° C. for 10 min. After cooled to room temperature, it was washed with brine and extracted with EtOAc (5×). The combined organic layer was dried (Na 2 SO 4 ) and concentrated. The residue was filtered through a short column of silica gel to provide N-butyl-7-(trans-4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine which was used for next step without further purification. [0108] A solution of crude N-butyl-7-(trans-4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-5-(4-fluorophenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine in MeOH (2.0 mL) was added a concentrated HCl solution (3 drops, 37% in water). The resulting solution was stirred at room temperature overnight, then concentrated. The residue was purified by pre-HPLC to provide the desired product (UNC1671A) (0.025 g, 36% over 3 steps). 1H NMR (400 MHz, CD 3 OD) δ 8.73 (s, 1H), 7.80 (s, 1H), 7.69-7.62 (m, 2H), 7.24-7.16 (m, 2H), 4.64-4.52 (m, 1H), 3.79-3.67 (m, 1H), 3.55 (t, J=7.1 Hz, 2H), 2.18-2.11 (m, 2H), 2.11-2.01 (m, 4H), 1.77-1.66 (m, 2H), 1.59-1.44 (m, 4H), 1.03 (t, J=7.4 Hz, 3H); MS m/z 383.2 [M+H] + . [0000] Table 2 describes compounds prepared following procedures described in Example 2 (General Procedure B), using appropriate reagents. Physical Data MS m/z (M + 1) Mer or/and 1 H NMR Structure Compound_ID IC 50 (400 MHz, CD 3 OD)  1 UNC1970A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.75 (s, 1H), 7.81 (s, 1H), 7.71-7.62 (m, 2H), 7.25-7.16 (m, 2H), 4.72-4.60 (m, 1H), 3.55 (t, J = 7.1 Hz, 2H), 2.30-2.22 (m, 2H), 2.23-2.03 (m, 4H), 1.79-1.63 (m, 4H), 1.55-1.44 (m, 2H), 1.02 (t, J = 7.4 Hz, 3H); MS m/z 382.25 [M + H] + .  2 UNC1971A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.92 (s, 1H), 8.13 (s, 1H), 7.94-7.84 (m, 1H), 7.78-7.64 (m, 2H), 4.66 (dq, J = 9.8, 4.6 Hz, 1H), 3.75-3.68 (m, 4H), 3.56 (t, J = 7.1 Hz, 2H), 3.35-3.26 (m, 1H), 3.19-3.12 (m, 4H), 2.31-2.10 (m, 6H), 1.84-1.60 (m, 4H), 1.57-1.40 (m, 2H), 1.02 (t, J = 7.4 Hz, 3H); MS m/z 531.30 [M + H] + .  3 UNC1972A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.89 (s, 1H), 8.07 (s, 1H), 7.97-7.89 (m, 2H), 7.85 (d, J = 8.5 Hz, 2H), 4.73-4.64 (m, 1H), 3.74-3.70 (m, 4H), 3.56 (t, J = 7.1 Hz, 2H), 3.35-3.26 (m, 1H), 3.03-2.97 (m, 4H), 2.36-2.08 (m, 6H), 1.81-1.64 (m, 4H), 1.57-1.41 (m, 2H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 513.30 [M + H] + .  4 UNC2025A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.83 (s, 1H), 7.96 (s, 1H), 7.80 (d, J = 8.3 Hz, 2H), 7.74 (d, J = 8.4 Hz, 2H), 4.66- 4.56 (m, 1H), 4.53 (s, 2H), 3.91-3.58 (m, 9H), 3.55 (t, J = 7.1 Hz, 2H), 3.02 (s, 3H), 2.19- 2.11 (m, 2H), 2.11- 1.99 (m, 4H), 1.78- 1.66 (m, 2H), 1.58- 1.41 (m, 4H), 1.02 (t, J = 7.4 Hz, 3H); 13 C NMR (101 MHz, CD 3 OD) δ 154.6, 151.1, 138.7, 134.0, 132.1, 127.2, 127.0, 116.7, 110.0, 109.9, 68.5, 53.9, 50.0, 40.9, 33.7, 30.6, 29.5, 19.6, 12.7; MS m/z 477.35 [M + H] + .  5 UNC2026A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.85 (s, 1H), 8.02 (s, 1H), 7.94-7.84 (m, 4H), 4.65-4.55 (m, 1H), 3.98 (dd, J = 11.5, 3.9 Hz, 2H), 3.78-3.67 (m, 1H), 3.54 (t, J = 7.1 Hz, 2H), 3.43-3.26 (m, 5H), 2.20-2.00 (m, 6H), 1.84 (d, J = 10.7 Hz, 2H), 1.77-1.64 (m, 4H), 1.59-1.42 (m, 4H), 1.02 (t, J = 7.4 Hz, 3H); MS m/z 513.30 [M + H] + .  6 UNC2087A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.86 (s, 1H), 8.07 (s, 1H), 8.01-7.95 (m, 2H), 7.95-7.88 (m, 2H), 4.68-4.57 (m, 1H), 3.77-3.67 (m, 2H), 3.56 (t, J = 7.1 Hz, 2H), 2.20-1.97 (m, 8H), 1.95-1.85 (m, 2H), 1.79-1.62 (m, 6H), 1.58-1.43 (m, 4H), 1.07-0.98 (m, 3H); MS m/z 497.30 [M + H] + .  7 UNC2078A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.85 (s, 1H), 8.04 (s, 1H), 7.92-7.86 (m, 2H), 7.86-7.80 (m, 2H), 4.66-4.57 (m, 1H), 3.77-3.68 (m, 1H), 3.56 (t, J = 7.1 Hz, 2H), 3.06-2.94 (m, 4H), 2.19-1.98 (m, 6H), 1.78-1.68 (m, 2H), 1.68-1.60 (m, 4H), 1.59-1.38 (m, 6H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 512.30 [M + H] + .  8 UNC2094A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.76 (s, 1H), 7.87 (s, 1H), 7.63-7.55 (m, 1H), 7.48-7.42 (m, 1H), 7.40-7.32 (m, 1H), 4.65-4.52 (m, 1H), 3.76-3.66 (m, 1H), 3.55 (t, J = 7.1 Hz, 2H), 2.19-1.98 (m, 6H), 1.75-1.66 (m, 2H), 1.59-1.44 (m, 4H), 1.02 (t, J = 7.4 Hz, 3H); MS m/z 401.20 [M + H] + .  9 UNC2095A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.85 (s, 1H), 8.04 (s, 1H), 7.93-7.85 (m, 4H), 4.67-4.52 (m, 1H), 3.78-3.64 (m, 1H), 3.55 (t, J = 7.2 Hz, 2H), 3.26-3.19 (m, 4H), 2.21-1.95 (m, 10H), 1.75-1.68 (m, 2H), 1.57-1.44 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 548.25 [M + H] + . 10 UNC2123A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.62 (s, 1H), 7.64 (s, 1H), 7.57-7.48 (m, 2H), 7.13-7.03 (m, 2H), 4.59-4.44 (m, 1H), 3.54-3.45 (m, 2H), 3.20-3.11 (m, 1H), 2.20-1.92 (m, 6H), 1.64-1.40 (m, 4H), 0.75-0.61 (m, 1H), 0.44-0.32 (m, 2H), 0.07 0.08 (m, 2H); MS m/z 394.25 [M + H] + . 11 UNC2124A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.75 (d, J = 4.9 Hz, 1H), 7.77 (d, J = 1.4 Hz, 1H), 7.70- 7.59 (m, 2H), 7.26- 7.14 (m, 2H), 4.70- 4.61 (m, 1H), 4.48 (t, J = 6.3 Hz, 2H), 3.69- 3.54 (m, 4H), 2.29- 2.10 (m, 6H), 1.94- 1.63 (m, 6H); MS m/z 398.30 [M + H] + . 12 UNC2125A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.71 (s, 1H), 7.80 (s, 1H), 7.51 (ddd, J = 11.7, 7.6, 2.2 Hz, 1H), 7.41-7.35 (m, 1H), 7.32-7.24 (m, 1H), 4.61-4.52 (m, 1H), 3.46 (t, J = 7.1 Hz, 2H), 3.26-3.18 (m, 1H), 2.22-2.14 (m, 2H), 2.13-1.98 (m, 4H), 1.68-1.54 (m, 4H), 1.46-1.34 (m, 2H), 0.93 (t, J = 7.4 Hz, 3H); MS m/z 400.30 [M + H] + . 13 UNC2142A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.81 (s, 1H), 7.95 (s, 1H), 7.83-7.77 (m, 2H), 7.69-7.63 (m, 2H), 4.66-4.57 (m, 1H), 4.41 (s, 2H), 4.05 (d, J = 12.7 Hz, 2H), 3.84-3.69 (m, 3H), 3.55 (t, J = 7.1 Hz, 2H), 3.44-3.36 (m, 2H), 3.28-3.18 (m, 2H), 2.18-2.11 (m, 2H), 2.11-2.01 (m, 4H), 1.77-1.68 (m, 2H), 1.57-1.44 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 464.30 [M + H] + . 14 UNC2143A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.81 (s, 1H), 7.95 (s, 1H), 7.82-7.76 (m, 2H), 7.75-7.69 (m, 2H), 4.65-4.57 (m, 1H), 4.48 (s, 2H), 3.77- 3.69 (m, 1H), 3.66- 3.50 (m, 10H), 2.20- 2.03 (m, 6H), 1.77- 1.67 (m, 2H), 1.58- 1.45 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 463.30 [M + H] + . 15 UNC2146A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.87 (s, 1H), 8.09 (s, 1H), 8.00-7.92 (m, 4H), 4.66-4.58 (m, 1H), 4.22 (t, J = 12.3Hz, 4H), 3.76-3.69 (m, 1H), 3.56 (t, .J = 7.1 Hz, 2H), 2.21-2.00 (m, 6H), 1.76-1.68 (m, 2H), 1.60-1.45 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 520.20 [M + H] + . 16 UNC2253A ++++ 1 H NMR (400 MHz, cd3od) δ 8.83 (s, 1H), 7.96 (s, 1H), 7.80 (d, J = 8.1 Hz, 2H), 7.70 (d, J = 8.0 Hz, 2H), 4.66- 4.55 (m, 1H), 3.92 (s, 4H), 3.80-3.62 (m, 2H), 3.56 (t, J = 7.2 Hz, 2H), 3.24-2.97 (m, 2H), 2.26-1.94 (m, 7H), 1.78-1.65 (m, 4H), 1.59-1.44 (m, 4H), 1.32 (t, J = 6.4 Hz, 2H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 490.30 [M + H] + . 17 UNC2367A ++++ 1 H NMR (400 MHz, cd3od) δ 8.59 (d, J = 1.4 Hz, 1H), 7.85 (s, 1H), 7.81 (d, J = 8.0 Hz, 1H), 7.57-7.52 (m, 2H), 4.54-4.42 (m, 1H), 3.94-3.68 (m, 2H), 3.69-3.53 (m, 2H), 3.54-3.48 (m, 2H), 3.46-3.29 (m, 2H), 3.14-3.00 (m, 1H), 2.77 (s, 5H), 2.08- 1.86 (m, 6H), 1.49 (dd, J = 14.3, 7.1 Hz, 2H), 1.46-1.33 (m, 2H), 0.73-0.63 (m, 1H), 0.41-0.34 (m, 2H), 0.02 (dd, J = 4.8, 1.2 Hz, 2H); MS m/z 557.30 [M + H] + . 18 UNC2368A ++++ 1 H NMR (400 MHz, cd3od) δ 8.60 (d, J = 1.5 Hz, 1H), 7.85 (d, J = 0.6 Hz, 1H), 7.81- 7.75 (m, 1H), 7.53 (s, 1H), 7.52-7.49 (m, 1H), 4.55-4.41 (m, 1H), 3.83 (s, 1H), 3.63- 3.54 (m, 5H), 3.54- 3.46 (m, 2H), 3.20 (s, 1H), 2.91-2.84 (m, 4H), 2.06-1.85 (m, 6H), 1.53-1.34 (m, 4H), 0.73-0.64 (m, 1H), 0.42-0.34 (m, 2H), 0.02 (d, J = 4.9 Hz, 2H); MS m/z 544.30 [M + H] + . 19 UNC2370A ++++ 1 H NMR (400 MHz, cd3od) δ 8.67 (s, 1H), 7.79 (s, 1H), 7.67-7.60 (m, 2H), 7.52-7.46 (m, 2H), 4.52-4.42 (m, 1H), 4.26 (s, 2H),3.97- 3.85 (m, 2H), 3.71- 3.55 (m, 3H), 3.54- 3.45 (m, 2H), 3.33- 3.20 (m, 2H), 3.14- 3.01 (m, 2H), 2.06- 1.98 (m, 2H), 1.97- 1.84 (m, 4H), 1.53- 1.45 (m, 2H), 1.45- 1.33 (m, 2H), 0.74- 0.62 (m, 1H), 0.42- 0.33 (m, 2H), 0.06- 0.03 (m, 2H); MS m/z 476.30 [M + H] + . 20 UNC2371A ++++ 1 H NMR (400 MHz, cd3od) δ 8.58 (s, 1H), 7.47 (d, J = 8.2 Hz, 2H), 7.28-7.21 (m, 3H), 4.48-4.36 (m, 1H), 3.66-3.53 (m, 1H), 3.47-3.37 (m, 4H), 2.53-2.29 (m, 6H), 2.19 (s, 3H), 2.06- 1.97 (m, 2H), 1.96- 1.81 (m, 4H), 1.50- 1.34 (m, 4H), 1.23- 1.09 (m, 1H), 0.90- 0.63 (m, 2H), 0.42- 0.34 (m, 2H), 0.06- 0.03 (m, 2H); MS m/z 489.40 [M + H] + . 21 UNC2395A 1 H NMR (400 MHz, cd3od) δ 8.80 (s, 1H), 7.93 (s, 1H), 7.81-7.74 (m, 2H), 7.62 (d, J = 8.3 Hz, 2H), 4.68-4.56 (m, 1H), 4.40 (s, 2H), 4.11-3.95 (m, 2H), 3.83-3.68 (m, 3H), 3.68-3.54 (m, 4H), 3.50-3.35 (m, 2H), 3.29-3.16 (m, 2H), 2.20-1.99 (m, 7H), 1.88-1.76 (m, 2H), 1.74-1.63 (m, 2H), 1.60-1.45 (m, 2H); MS m/z 480.30 [M + H] + . 22 UNC2396A 1 H NMR (400 MHz, cd3od) δ 8.77 (s, 1H), 7.88 (d, J = 4.2 Hz, 1H), 7.71 (d, J = 8.3 Hz, 2H), 7.56 (d, J = 8.3 Hz, 2H), 4.65-4.56 (m, 1H), 4.16 (s, 2H), 3.79-3.67 (m, 1H), 3.67-3.62 (m, 2H), 3.62-3.55 (m, 2H), 3.50 (s, 4H), 3.29-3.24 (m, 1H), 2.93 (s, 3H), 2.26-1.91 (m, 7H), 1.86-1.73 (m, 2H), 1.73-1.63 (m, 2H), 1.60-1.46 (m, 2H); MS m/z 493.40 [M + H] + . 23 UNC1651A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.92 (s, 1H), 8.14 (s, 1H), 7.88 (t, J = 6.6 Hz, 1H), 7.76- 7.63 (m, J = 10.8 Hz, 2H), 4.68-4.55 (d, J = 10.7 Hz, 1H), 3.80- 3.68 (m, 1H), 3.61- 3.49 (m, 4H), 3.36 (bs, 4H), 3.09 (bs, 4H), 2.21-1.99 (m, 6H), 1.79-1.67 (m, 2H), 1.59-1.45 (m, 4H), 1.03 (t, J = 7.3 Hz, 3H); MS m/z 613.3 [M + H] + . 24 UNC1652A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.91 (s, 1H), 8.14 (s, 1H), 7.90 (t, J = 8.0 Hz, 1H), 7.77- 7.68 (m, 2H), 4.66 (tt, J = 12.0, 3.7 Hz, 1H), 4.09 (bs, 1H), 3.57 (t, J = 7.1 Hz, 2H), 3.40 (q, J = 9.6 Hz, 2H), 3.34- 3.31 (m, 4H), 3.03- 2.92 (m, 4H), 2.42- 2.26 (m, 2H), 2.01 (d, J = 14.9 Hz, 2H), 1.91- 1.67 (m, 6H), 1.49 (dq, J = 14.5, 7.3 Hz, 2H), 1.02 (t, J = 7.4 Hz, 3H); MS m/z 613.2 [M + H] + . 25 UNC1666A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 9.23 (s, 1H), 8.03 (dd, J = 8.7, 5.3 Hz, 2H), 7.30 (t, J = 8.7 Hz, 2H), 4.27 (d, J = 6.5 Hz, 2H), 3.86-3.51 (m, 9H), 3.46-3.35 (m, 1H), 2.27 (d, J = 11.0 Hz, 2H), 2.14 (bs, 1H), 1.98 (d, J = 12.8 Hz, 2H), 1.76-1.68 (m, 2H), 1.41-1.60 (m, 1H), 1.54-1.42 (m, 2H), 1.41-1.30 (m, 2H), 1.02 (t, J = 7.3 Hz, 3H); MS m/z 514.3 [M + H] + . 26 UNC1667A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.91 (s, 1H), 8.10 (s, 1H), 7.95 (d, J = 8.5 Hz, 2H), 7.89 (d, J = 8.5 Hz, 2H), 4.68-4.56 (m, 1H), 3.95 (bs, 2H), 3.79-3.68 (m, 1H), 3.66-3.50 (m, 4H), 3.30-3.14 (m, 2H), 2.90 (s, 3H), 2.83 (bs, 2H), 2.21-2.03 (m, 6H), 1,78-1.67 (m, 2H), 1.61-1.43 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H); MS m/z 527.3 [M + H] + . 27 UNC1668A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.78 (s, 1H), 7.85 (s, 1H), 7.48 (t, J = 2.1 Hz, 1H), 7.45 (s, 1H), 7.28 (t, J = 8.5 Hz, 1H), 4.64-4.53 (m, 1H), 3.94-3.87 (m, 4H), 3.78-3.68 (m, 1H), 3.55 (t, J = 7.1 Hz, 2H), 3.27-3.21 (m, 4H), 2.19-2.10 (m, 2H), 2.10-2.02 (m, 4H), 1.77-1.67 (m, 2H), 1.58-1.44 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H).; MS m/z 468.3 [M + H] + . 28 UNC1669A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.94 (s, 1H), 8.16 (s, 1H), 7.95-7.86 (m, 1H), 7.77-7.68 (m, 2H), 4.67-4.55 (m, 1H), 4.13-3.92 (bs, 2H), 3.78-3.68 (m, 1H), 3.68-3.49 (m, 4H), 3.30-3.19 (bs, 2H), 3.18-3.02 (bs, 2H), 2.93 (s, 3H), 2.21- 2.01 (m, 6H), 1.78- 1.66 (m, 2H), 1.60- 1.43 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H).; MS m/z 545.3 [M + H] + . 29 UNC1670A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.91 (s, 1H), 8.13 (s, 1H), 7.91-7.83 (m, 1H), 7.73-7.64 (m, 2H), 4.66-4.57 (m, 1H), 3.79-3.67 (m, 5H), 3.56 (t, J = 7.1 Hz, 2H), 3.19-3.11 (m, 4H), 2.20-2.01 (m, 6H), 1.78-1.68 (m, 2H), 1.60-1.44 (m, 4H), 1.03 (t, J = 7.4 Hz, 3H).; MS m/z 532.2 [M + H] + . 30 UNC2369A ++ 1 H NMR (400 MHz, CD 3 OD) δ 8.63 (s, 1H), 7.88 (s, 1H), 7.71 (d, J = 8 Hz, 2H), 7.63 (d, J = 8 Hz, 2H), 4.53-4.38 (m, 1H), 4.38 (s, 2H), 3.72-3.56 (m, 8H), 3.50 (s, 3H), 2.92 (s, 3H), 2.06-1.97 (m, 6H), 1.67-1.63 (m, 3H), 1.42-1.34 (m, 5H), 0.93 (t, J = 8 Hz, 3H). MS m/z 491.0 [M + H] + . (Note: Mer IC50: ++++ means <10 nM; +++ means between 10-100 nM, ++ means between 100 nM-1 μM; + means between 1-30 μM; − means inactive.) Example 3 Cis- and Trans-(1r,4r)-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol General Procedure C: [0109] N-Butyl-5H-pyrrolo[3,2-d]pyrimidin-2-amine [0110] [0111] A suspension of 2-chloro-5H-pyrrolo[3,2-d]pyrimidine (0.62 g, 4 mmol) in 5 mL iPrOH was added nBuNH 2 (2.5 mL, 25.3 mmol) and followed by HCl (2.0 mL, 4.0 M in dioxanes, 8 mmol). The resulting solution was heated at 170° C. for 1 h under microwave irradiation. The reaction was monitored by LC-MS. The reaction time should be extended whenever it is necessary. After evaporation of solvents, the crude product was washed with minimal amount of MeOH. The solid was collected. And the MeOH filtrate was purified by ISCO to provide the desired product (0.73 g, 96%). 1 H NMR (400 MHz, CD 3 OD) δ 8.42 (d, J=0.8 Hz, 1H), 7.53 (d, J=3.1 Hz, 1H), 6.27 (dd, J=3.0, 0.8 Hz, 1H), 3.37 (t, J=7.1 Hz, 2H), 1.68-1.57 (m, 2H), 1.52-1.36 (m, 2H), 0.97 (t, J=7.4 Hz, 3H); MS m/z 191.2 [M+H] + . N-Butyl-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine [0112] [0113] A mixture of N-butyl-5H-pyrrolo[3,2-d]pyrimidin-2-amine (0.73 g, 3.85 mmol), CuI (0.074 g, 0.39 mmol), and K 3 PO 4 (1.63 g, 7.7 mmol) was added DMF (10 mL), 4-fluoroiodobenzene (0.54 mL, 4.62 mmol), and N,N′-dimethylcyclohexane-1,2-diamine (0.24 mL, 1.54 mmol) under Argon atmosphere. The mixture was heated at 110° C. for 16 h, then was filtered through a plug of celite at room temperature and washed with MeOH. The filtrate was concentrated and purified by ISCO to provide desired product (1.079 g, 99%). MS m/z 285.2 [M+H] + . 7-Bromo-N-butyl-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine [0114] [0115] A solution of N-butyl-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine (1.03 g, 3.61 mmol) in DMF (10 mL) was added NBS (0.71 g, 3.97 mmol) at room temperature. The resulting solution was stirred for 1 h and diluted with EtOAc. The resulting solution was washed with a sat. aq. solution of NaHCO 3 , H 2 O and brine. The EtOAc layer was dried (Na 2 SO 4 ), concentrated and purified by ISCO to provide the desired product (1.05 g, 80%). 1 H NMR (400 MHz, CD 3 OD) δ 8.46 (s, 1H), 7.68 (s, 1H), 7.52-7.42 (m, 2H), 7.32-7.21 (m, 2H), 3.44 (t, J=7.1 Hz, 2H), 1.68-1.54 (m, 2H), 1.49-1.36 (m, 2H), 0.95 (t, J=7.3 Hz, 3H); MS m/z 363.1 [M+H] + . N-Butyl-7-(4-(tert-butyldimethylsilyloxy)cyclohex-1-enyl)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine [0116] [0117] A mixture of 7-bromo-N-butyl-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine (0.11 g, 0.3 mmol), tert-butyldimethyl(4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)cyclohex-3-enyloxy)silane (0.15 g, 0.45 mmol), potassium phosphonate (0.083 g, 0.60 mmol), tetrakis(triphenylphosphine)palladium (0.035 g, 0.03 mmol) in THF (4 mL) and water (1 mL) was stirred at room temperature for 1 min, then was heat at 150° C. for 1 h under microwave irradiation. The reaction mixture was diluted with EtOAc and washed with water. The aqueous layer was extracted with EtOAc (3×). The combined organic layer was dried (Na 2 SO 4 ), concentrated, and purified by ISCO to provide the desired product (0.12 g, 83%). 1 H NMR (400 MHz, CDCl 3 ) δ 8.48 (s, 1H), 7.41-7.34 (m, 2H), 7.32 (s, 1H), 7.20 (t, J=8.5 Hz, 2H), 7.17-7.12 (m, 1H), 4.97 (t, J=5.6 Hz, 1H), 4.09-3.95 (m, 1H), 3.49 (dd, J=13.3, 6.5 Hz, 2H), 2.68-2.44 (m, 3H), 2.35-2.23 (m, 1H), 2.03-1.94 (m, 1H), 1.86-1.74 (m, 1H), 1.72-1.59 (m, 2H), 1.52-1.39 (m, 2H), 0.97 (t, J=7.3 Hz, 3H), 0.92 (s, 9H), 0.10 (s, 6H); MS m/z 495.3 [M+H] + . 4-(2-(Butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohex-3-enol [0118] [0119] A solution of N-butyl-7-(4-(tert-butyldimethylsilyloxy)cyclohex-1-enyl)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine (0.12 g, 0.25 mmol) in EtOH (5 mL) was added 2 drops of concentrated HCl solution. The resulting reaction mixture was stirred at room temperature for 16 h and concentrated to give the desired product use as such. 1 H NMR (400 MHz, CD 3 OD) δ 8.59 (s, 1H), 8.23 (s, 1H), 7.66-7.58 (m, 2H), 7.40-7.31 (m, 2H), 6.88 (s, 1H), 4.05-3.93 (m, 1H), 3.54 (t, J=7.2 Hz, 2H), 2.77-2.66 (m, 1H), 2.63-2.51 (m, 2H), 2.28-2.16 (m, 1H), 2.11-1.99 (m, 1H), 1.85-1.75 (m, 1H), 1.75-1.65 (m, 2H), 1.54-1.40 (m, 2H), 1.01 (t, J=7.4 Hz, 3H); MS m/z 381.2 [M+H] + . Cis- and Trans-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol [0120] [0121] A mixture of 4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohex-3-enol (0.095 g, 0.25 mmol) and Pd/C (0.01 g, 10 wt %) in 5 mL MeOH was stirred under H 2 atmosphere for 3 h. After filter through a plug of celite, the filtrate was concentrated and purified by Prep-HPLC. The cis-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol was obtained as the major product (0.040 g). The trans-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol was co-elute with 4-(2-(butylamino)-5-(4-fluorophenyl)-6,7-dihydro-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol (0.035 g). [0122] A solution of mixture of trans-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol and 4-(2-(butylamino)-5-(4-fluorophenyl)-6,7-dihydro-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol (0.035 g, 0.091 mmol) in 5 mL MeOH was added Pd/C (0.004 g, 10 wt %). The mixture was stirred overnight under air. After filter through a plug of celite, the filtrate was concentrated and purified by ISCO to provide cis-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol (0.010 g, 13% over 3 steps) and trans-4-(2-(butylamino)-5-(4-fluorophenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol (0.012 g+0.040 g, 52% over 3 steps). Cis-isomer (UNC1861A): 1 H NMR (400 MHz, CD 3 OD) δ 8.47 (s, 1H), 7.55-7.49 (m, 3H), 7.32-7.25 (m, 2H), 4.06-3.99 (m, 1H), 3.43 (t, J=7.1 Hz, 2H), 2.97 (tt, J=10.6, 3.7 Hz, 1H), 2.06-1.96 (m, 2H), 1.93-1.82 (m, 4H), 1.79-1.68 (m, 2H), 1.68-1.59 (m, 2H), 1.49-1.39 (m, 2H), 0.97 (t, J=7.4 Hz, 3H); MS m/z 383.3 [M+H] + . Trans-isomer (UNC1860A): 1 H NMR (400 MHz, CD 3 OD) δ 8.45 (s, 1H), 7.53-7.47 (m, 3H), 7.28 (t, J=8.7 Hz, 2H), 3.69-3.57 (m, 1H), 3.42 (t, J=7.1 Hz, 2H), 2.83 (tt, J=12.4, 3.2 Hz 1H), 2.20-2.13 (m, 2H), 2.11-2.02 (m, 2H), 1.73-1.58 (m, 4H), 1.53-1.39 (m, 4H), 0.98 (t, J=7.4 Hz, 3H); MS m/z 383.3 [M+H] + . Example 4 4-(2-(Butylamino)-5-(4-(morpholinomethyl)phenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol General Procedure D: [0123] 7-Bromo-2-chloro-5H-pyrrolo[3,2-d]pyrimidine [0124] [0125] A solution of 2-chloro-5H-pyrrolo[3,2-d]pyrimidine (1.54 g, 10 mmol) in DMF (10 mL) was added NBS (2.00 g, 11 mmol) at room temperature. The resulting solution was stirred for 1 h and diluted with EtOAc. The resulting solution was washed with a sat. aq. solution of NaHCO 3 , H 2 O and brine. The EtOAc layer was dried (Na 2 SO 4 ), concentrated and purified by ISCO to provide the desired product (1.75 g, 75%). 1 H NMR (400 MHz, CD 3 OD) δ 8.53 (s, 1H), 7.60 (s, 1H); MS m/z 234.0 [M+H] + . 7-Bromo-2-chloro-5-trityl-5H-pyrrolo[3,2-d]pyrimidine [0126] [0127] A suspension of NaH (300 mg, 60% in mineral oil, 7.5 mmol) in THF (30 mL) was added a solution of 7-bromo-2-chloro-5H-pyrrolo[3,2-d]pyrimidine (1.16 g, 5.0 mmol) in THF (20 mL) dropwise at 0° C. After 20 min, a solution of TrCl (1.674 g, 6 mmol) in THF (10 mL) was added dropwise. The reaction mixture was stirred for 6 hours, quenched with brine and extracted with EtOAc (3×). The combined organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product (2.38 g, >99%). 1 H NMR (400 MHz, CD 3 OD) δ 7.63 (s, 1H), 7.57 (s, 1H), 7.37-7.32 (m, 9H), 7.14-7.11 (m, 6H). 4-((tert-Butyldimethylsilyl)oxy)-1-(2-chloro-5-trityl-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol [0128] [0129] A solution of 7-bromo-2-chloro-5-trityl-5H-pyrrolo[3,2-d]pyrimidine (2.00 g, 3.2 mmol) in THF (20 mL) was added a 2.5 N solution of BuLi in hexane (2.82 mL, 7.04 mmol) at −78° C. Then 4-((tert-butyldimethylsilyl)oxy)cyclohexanone (1.2 mL) was added after 15 min. The reaction was stirred at −78° C. for 3 hour, quenched with brine and extracted with EtOAc (3×). The combined organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product (1.52 g, 76%). 1 H NMR (400 MHz, CDCl 3 , two isomers) δ 7.64-7.56 (m, 1H), 7.44-7.41 (m, 1H), 7.35-7.31 (m, 9H), 7.16-7.10 (m, 6H), 3.73-3.68 (m, 1H), 2.55-2.51 (m, 1H), 2.42-2.30 (m, 1H), 2.28-2.19 (m, 1H), 2.07-1.94 (m, 2H), 1.91-1.82 (m, 2H), 1.76-1.62 (m, 2H), 0.82 (s, 9H), 0.01 (s, 6H). 7-(4-((tert-Butyldimethylsilyl)oxy)cyclohex-1-en-1-yl)-2-chloro-5-trityl-5H-pyrrolo[3,2-d]pyrimidine [0130] [0131] A solution of 4-((tert-butyldimethylsilyl)oxy)-1-(2-chloro-5-trityl-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohex-anol (1.00 g, 1.6 mmol) in CH 2 Cl 2 (20 mL) was added MsCl (275 mg, 2.4 mmol) followed by NEt 3 (808 mg, 8 mmol). The reaction mixture was stirred at room temperature for 6 hours, quenched with brine and extracted with EtOAc (3×). The combined organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product (485 mg, 50%). 1 H NMR (400 MHz, CDCl 3 ) δ 7.56 (s, 1H), 7.34 (s, 1H), 7.25-7.21 (m, 9H), 7.08-7.05 (m, 6H), 6.89 (s, 1H), 3.90-3.86 (m, 1H), 2.49-2.43 (m, 1H), 2.37-2.28 (m, 1H), 2.19-2.13 (m, 1H), 1.85-1.82 (m, 1H), 1.68-1.62 (m, 2H), 0.82 (s, 9H), 0.00 (s, 6H). N-Butyl-7-(4-((tert-butyldimethylsilyl)oxy)cyclohex-1-en-1-yl)-5-trityl-5H-pyrrolo[3,2-d]pyrimidin-2-amine [0132] [0133] A solution of 7-(4-((tert-butyldimethylsilyl)oxy)cyclohex-1-en-1-yl)-2-chloro-5-trityl-5H-pyrrolo[3,2-d]pyra-midine (485 mg, 0.8 mmol) in dioxane (3.0 mL) was added Pd 2 (dba) 3 (73 mg, 0.08 mmol). The reaction mixture was stirred until the solution became clear. Then 2-dicyclohexylphosphino-2′,4′,6′-triisopropylbiphenyl (152 mg, 0.32 mmol) was added followed by the addition of water (4.0 mL) and potassium hydroxide (135 mg, 2.4 mmol). The reaction mixture was heated under reflux for 12 hours under Argon atmosphere, then cooled to room temperature. The reaction was diluted with EtOAc. The organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product (360 mg, 70%). 1 H NMR (400 MHz, CDCl 3 ) δ 7.40 (s, 1H), 7.30-7.28 (m, 9H), 7.19-7.15 (m, 7H), 7.07 (s, 1H), 3.98-3.92 (m, 1H), 3.42-3.37 (dd, J 1 =12 Hz, J 2 =8 Hz, 2H), 2.55-2.47 (m, 1H), 2.42-2.32 (m, 1H), 2.28-2.21 (m, 1H), 1.93-1.86 (m, 1H), 1.75-1.70 (m, 2H), 1.69-1.58 (m, 2H), 1.46-1.37 (m, 2H), 0.89 (t, J=4 Hz, 3H), 0.82 (s, 9H), 0.00 (s, 6H). 4-(2-(Butylamino)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol [0134] [0135] A solution of N-Butyl-7-(4-((tert-butyldimethylsilyl)oxy)cyclohex-1-en-1-yl)-5-trityl-5H-pyrrolo[3,2-d]pyrim-idin-2-amine (992 mg, 1.54 mmol) in CH 2 Cl 2 (20 mL) was added trifluoroacetic acid (5.0 mL). The reaction mixture was stirred for 4 hours and quenched by a saturated aq. solution of NaHCO 3 and diluted with EtOAc. The organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was dissolved in MeOH (6.0 mL) and Pd/C (44 mg) was added. The reaction mixture was then stirred under the hydrogen atmosphere for 12 hours and then filtered. The filtrate was concentrated to afford a brown residue. A solution of the residue in CH 2 Cl 2 (10 mL) was added a mixture of PCC (665 Mg, 3.084 mmol) and silica gel (668 mg). After 30 min, the reaction was quenched with water and extracted with EtOAc (3×). The combined organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product 4-(2-(butylamino)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanone (MS m/z 287.2 [M+H] + ). A solution of 4-(2-(butylamino)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanone in MeOH (10 mL) was added NaBH 4 (67 mg, 1.71 mmol) slowly at −40° C. The reaction was quenched with water after 1 h and extracted with EtOAc (3×). The combined organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product which was used without further purification. MS m/z 289.2 [M+H] + . N-Butyl-7-(4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-5-(4-(morpholinomethyl)phenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine [0136] [0137] A solution of 4-(2-(butylamino)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol (122 mg, 0.423 mmol) and TBSCl (77 mg, 0.51 mmol) in THF (3 mL) was added imidazole (44 mg, 0.636 mmol). The reaction mixture was stirred for 6 hours, quenched with water and extracted with EtOAc (3×). The combined organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product N-butyl-7-(4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine (59 mg, 0.14653 mmol). MS m/z 403.3 [M+H] + . [0138] A solution of N-butyl-7-(4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine (59 mg, 0.14653 mmol) and 4-iodobenzyl morpholine (67 mg, 0.22 mmol) in NMP (1 mL) was added CuI (3 mg, 0.022 mmol) and N,N′-dimethylcyclohexane-1,2-diamine (2 mg, 0.044 mmol). The reaction mixture was stirred under microwave irradiation at 195° C. for 30 min. Then the reaction was diluted with EtOAc. The organic layer was dried (MgSO 4 ), filtered and concentrated. The residue was purified by ISCO to provide the desired product (85 mg, 99%). 1 H NMR (400 MHz, CDCl 3 ) δ 8.48 (s, 1H), 7.36 (d, J=8 Hz, 2H), 7.25 (d, J=8 Hz, 2H), 7.17 (s, 1H), 4.86 (s, 1H), 3.71-3.52 (m, 4H), 3.44-3.38 (m, 4H), 3.32-3.17 (m, 1H), 2.81-2.71 (m, 2H), 2.45-2.33 (m, 4H), 2.15-2.04 (m, 2H), 1.96-1.83 (m, 2H), 1.61-1.29 (m, 8H), 0.94-0.75 (m, 12H), 0.00 (s, 6H). MS m/z 578.4 [M+H] + . 4-(2-(Butylamino)-5-(4-(morpholinomethyl)phenyl)-5H-pyrrolo[3,2-d]pyrimidin-7-yl)cyclohexanol [0139] [0140] A solution of N-butyl-7-(4-((tert-butyldimethylsilyl)oxy)cyclohexyl)-5-(4-(morpholinomethyl)phenyl)-5H-pyrrolo[3,2-d]pyrimidin-2-amine (84 mg, 0.14653 mmol) in MeOH (3.0 mL) was added 0.15 mL of concentrated HCl. The reaction mixture was stirred overnight and the solvent was removed. The residue was purified by ISCO to provide the desired product (UNC2221A) (68 mg, 99%). 1 H NMR (400 MHz, CD 3 OD) δ 8.69 (s, 1H), 8.13 (s, 1H), 7.74 (d, J=8 Hz, 2H), 7.25 (d, J=8 Hz, 2H), 4.38 (s, 2H), 4.01-3.92 (m, 2H), 180-3.70 (m, 2H), 3.59-3.52 (m, 2H), 3.48 (t, J=8 Hz, 2H), 3.37-3.29 (m, 2H), 3.18-3.11 (m, 1H), 2.78 (tt, J 1 =12 Hz, J 2 =4 Hz, 1H), 2.02 (t, J=16 Hz, 4H), 1.68-1.57 (m, 4H), 1.43-1.13 (m, 4H), 0.91 (t, J=8 Hz, 3H). MS m/z 464.3 [M+H] + . [0000] Table 3 describes compounds prepared following procedures described in Example 4 (General Procedure D), using appropriate reagents. Physical Data Mer MS m/z (M + 1) or/and 1 H NMR Structure Compound_ID IC 50 (400 MHz, CD 3 OD) 1 UNC2421A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.79 (s, 1H), 8.21 (s, 1H), 7.89 (d, J = 8 Hz, 2H), 7.71 (d, J = 8 Hz, 2H), 5.47 (s, 1H), 4.61 (s, 2H), 3.74-3.71 (m, 6H), 3.67-3.63 (m, 2H), 3.58-3.54 (m, 2H), 3.33 (s, 1H), 3.01 (s, 3H), 2.86 (t, J = 12 Hz, 1H), 2.65 (s, 1H), 2.13-2.06 (m, 4H), 1.70-1.67 (m, 4H), 1.47-1.45 (m, 4H), 0.98 (t, J = 8 Hz, 3H); MS m/z 477.0 [M + 1] + . 2 UNC2433A ++++ 1 H NMR (400 MHz, CD 3 OD) δ 8.80 (s, 1H), 8.31 (s, 1H), 7.74 (d, J = 8 Hz, 2H), 8.02 (d, J = 4 Hz, 2H), 7.86 (d, J = 4 Hz, 2H), 4.38 (s, 2H), 3.78-3.72 (m, 1H), 3.71-3.68 (m, 2H), 3.63- 3.59 (m, 2H), 3.08 (t, J = 8 Hz, 2H), 2.95-2.87 (m, 1H), 2.20-2.05 (m, 4H), 1.74-1.69 (m, 7H), 1.52-1.50 (m, 5H), 1.04 (t, J = 8 Hz, 3H); MS m/z 512.0 [M + 1] + . (Note: Mer IC50: ++++ means <10 nM; +++ means between 10-100 nM, ++ means between 100 nM-1 μM; + means between 1-30 μM; − means inactive.) Example 5 Macrocyclic Derivative of 5-(4-((4-methylpiperazin-1-yl)methyl)phenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine General Procedure E: [0141] Macrocyclic Derivative of 5-(4-((4-methylpiperazin-1-yl)methyl)phenyl)-7H-pyrrolo[2,3-d]pyrimidin-2-amine [0142] A suspension of 5-bromo-2-chloro-7H-pyrrolo[2,3-d]pyrimidine (100 mg, 0.43 mmol), 2-(3-bromopropyl)isoindoline-1,3-dione (173 mg, 0.65 mmol) and K 2 CO 3 (119 mg, 0.86 mmol) in a mixture of DMSO and THF (8.0 mL, 1:3, v/v) was heated at 100° C. under microwave irradiation for 30 min. The mixture was diluted with ethyl acetate (35 mL), washed with water (3×) and concentrated to provide the crude 2-(3-(5-bromo-2-chloro-7H-pyrrolo[2,3-d]pyrimidin-7-yl)propyl)isoindoline-1,3-dione (MS m/z 420.05 [M+H] + ) which was used in next step without further purification. [0143] A solution of the crude 2-(3-(5-bromo-2-chloro-7H-pyrrolo[2,3-d]pyrimidin-7-yl)propyl)isoindoline-1,3-dione in a mixture of THF and water (10 mL, 3:2, v/v) was added 5-aminopentanoic acid (172.3 mg, 1.47 mmol). The resulting mixture was heated at 150° C. under microwave irradiation for 1 h. After the solvent was removed, the residue was dissolved in a mixture of ethanol and water (20 mL, 3:2, v/v) followed by the addition of hydrazine (1.5 mL). Then the reaction mixture was heat at 80° C. for overnight. The solvent was removed and the residue was purified on HPLC to provide 5-((7-(3-aminopropyl)-5-bromo-7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)pentanoic acid as an clear oil (MS m/z 371.10 [M+H] + ). [0144] A solution of this clear oil in DMF/DCM (120 mL, 2:3, v/v) was added TBTU (115 mg) and triethylamine (2.2 mL). The reaction mixture was stirred at room temperature for overnight. Solvent was removed and the residue (MS m/z 353.10 [M+H] + ) was dissolved in dioxane (6.0 mL) followed by the addition of 4-(4-methylpiperazino)methylphenylboronic acid pinacol ester (135 mg, 0.43 mmol), Pd(PPh 3 ) 4 (12 mg, 0.01 mmol), K 2 CO 3 (128 mg, 0.93 mmol) and water (2.0 mL). The resulting mixture was heated at 150° C. under microwave irradiation for 15 min, quenched with water (15 mL), extracted with ethylacetate (4×), dried (MgSO 4 ) and concentrated. The residue was purified on HPLC to give the desired product as a TFA salt. This salt was neutralized with a 7 N NH 3 solution in methanol and was purified on ISCO to provide the desired product (UNC2434A) as a white solid. 1 H NMR (400 MHz, CD 3 OD) δ 8.66 (s, 1H), 7.60-7.53 (m, 2H), 7.35 (d, J=8.2 Hz, 2H), 7.31 (s, 1H), 5.47 (s, 2H), 4.27 (t, J=7.2 Hz, 2H), 3.54 (s, 2H), 3.47-3.40 (m, 2H), 3.19-3.13 (m, 2H), 2.57-2.46 (m, 6H), 2.42-2.38 (m, 2H), 2.27 (s, 3H), 1.96-1.89 (m, 2H), 1.80-1.71 (m, 2H), 1.71-1.61 (m, 2H); MS m/z 462.30 [M+H] + . [0145] The foregoing is illustrative of the present invention, and is not to be construed as limiting thereof. The invention is defined by the following claims, with equivalents of the claims to be included therein.

1a

RELATED APPLICATION [0001] This application claims priority of U.S. Provisional Patent Application 60/265,060 filed Jan. 30, 2001 which is incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention relates generally to systems and methods for delivering sanitized water and for decontaminating fluid delivery lines. More specifically, the invention relates to a system and method for providing a self-cleaning fluid delivery system. In specific embodiments, the invention is directed to a self-cleaning dental drilling and irrigation system. BACKGROUND OF THE INVENTION [0003] The formation of microbial biofilm is a significant problem in fluid delivery systems, particularly those used in dental, medical and food service applications, and various governmental and professional organizations are implementing standards and regulations for addressing this problem. Biofilm buildup occurs when bacteria or other microbes colonize tubing walls of fluid delivery systems. The biofilm forms a slime layer which fosters and protects growing microbes and hinders their removal and treatment. Generally, fluid flow in most delivery systems is laminar, and this favors the build up of biofilm. Biofilm represents a reservoir of contamination, and can support the growth of secondary organisms such as fungi, protozoa and nematodes. Biofilm can dislodge in the course of use of the system, and can present a significant source of infection. [0004] Biofilm build up is of particular concern in medical and dental applications. The problem is compounded because medical and dental fluid delivery systems are frequently highly complex, expensive and thus difficult to clean or replace. Heretofore, biofilm control was attempted by flushing fluid delivery systems with biocidal compositions. This approach has been found to be ineffective. As noted above, fluid flow through such systems is generally laminar; hence, a flowing biocide does not effectively interact with biofilms. These problems are compounded because of the smooth, adherent nature of most biofilms. In fact, such cleaning attempts have been found to encourage the growth of biocide resistant organisms within the biofilm. Highly aggressive cleaning compositions such as alkalis, acids or the like generally cannot be used in complex medical and dental fluid delivery systems, since such aggressive chemicals can damage sensitive components of the systems; furthermore, residues from such aggressive chemicals can present a hazard to patients. In view of the general ineffectiveness of such chemical treatment methods, the only other approach heretofore available was to disassemble and manually clean and/or replace components of the system. This approach is clearly very expensive and time consuming. Furthermore, new biofilm buildup occurs fairly rapidly. [0005] U.S. Pat. No. 5,556,279 discloses a system which employs iodine for purifying water supplied to a dental unit. The purified water limits the activity of microorganisms; however, it cannot completely stop biofilm buildup and does not function to remove biofilms which are already in place. Another approach to the problem of biofilms in dental systems is disclosed in U.S. Pat. No. 6,212,333. The system disclosed therein employs heat to sanitize incoming water. This sanitized water is then delivered by a pump to a dental workstation. Again, while the system of the '333 patent does sanitize water, this sanitized water is ineffective against biofilms already in the dental unit. Also, even though the water is heat sanitized, there is typically some residual biological activity which can initiate or contribute to biofilm growth. [0006] Clearly, there is a need for a system and method which can provide sanitized water to a dental unit or other such workstation, and which can further function to remove biofilm buildup therefrom. Ideally, biofilm removal should not require any disassembly of the fluid delivery system and should be accomplished without the use of corrosive or otherwise dangerous chemicals. As will be explained hereinbelow, the present invention comprises a system which is operable to provide sanitized water to a fluid delivery system and which is further operable to destroy and remove biofilms from that system. The sanitization process of the present invention is accomplished through the use of steam. The sanitization process of the present invention does not require disassembly of the equipment being sanitized, and hence is very useful for cleaning fluid delivery systems associated with dental and medical equipment such as drill motors, dialysis units and the like. The system of the present invention is simple in design and low in cost and can be incorporated into specific workstations or equipment. [0007] It is to be understood that while the system of the present invention is described and discussed herein with regard to dental and medical equipment, the benefits and advantages of the present invention will make it readily adaptable to all systems which require the delivery of sanitized fluid, and which are prone to biofilm buildup. As such, the present invention finds utility in connection with water coolers, beverage vending machines, soft drink and beer delivery systems, bottling systems and other food processing and delivery equipment. Biofilm buildup is also of concern in various industrial processes wherein microbial contamination can contaminate products or interfere with processing, and the present invention may be readily incorporated thereinto. In view of the teaching presented herein, it is to be understood that this invention may be employed in any application wherein there is a need to control and/or remove biofilm buildup in fluid systems. These and other advantages of the invention will be apparent from the drawings, discussion and description which follow. BRIEF DESCRIPTION OF THE INVENTION [0008] There is disclosed herein a self-cleaning system for delivering sanitized water to a workstation, such as a dental unit. The system includes a boiler which is connectable to a source of water by a water inlet and which is operable to provide steam and heat sanitized water. The system may optionally include a sanitized water reservoir which is integral with, or in fluid communication with, the boiler. The system further includes a sanitized water delivery line and a steam delivery line in fluid communication with the boiler, as well as a fluid delivery line. A diverter valve is in fluid communication with the sanitized water delivery line, the steam delivery line and the fluid delivery line, and is operable to selectively establish fluid communication between the fluid delivery line and either the steam delivery line or the sanitized water delivery line. In this manner, either sanitized water or steam may be delivered to the fluid delivery line. When steam is supplied to the line, this steam will function to destroy and remove biofilm contamination. [0009] In further embodiments of the present invention, a heat exchanger is disposed so as to cool the heat sanitized water coming from the boiler. The excess heat removed by the heat exchanger may be used to warm input water to the boiler and/or to heat a stream of air. In specific embodiments, the boiler operates at a pressure above atmospheric, typically 1.5 to 2.0 atmospheres, and the steam pressure generated thereby may be employed to move the sanitized water through the system without the aid of a pump. [0010] The system of the present invention may further include water softeners, filters or other conditioners associated with the water input line. In certain embodiments, the system may be further adapted to selectably introduce a biocidal composition into the fluid delivery line, and this biocide may be used in conjunction with the steam to aid in cleaning and sanitizing the fluid delivery system. BRIEF DESCRIPTION OF THE DRAWING [0011] [0011]FIG. 1 is a schematic view of one embodiment of water line system in accord with the present invention; [0012] [0012]FIG. 2 is a schematic depiction of another embodiment of water line decontamination system of the present invention which includes a chemical agent delivery unit; [0013] [0013]FIG. 3 is a schematic depiction of another embodiment of the present invention which operates to sanitize the air delivery line of a dental workstation; and [0014] [0014]FIG. 4 is a schematic depiction of the electrical system of the FIG. 3 unit. DETAILED DESCRIPTION OF THE INVENTION [0015] The present invention will be described with reference to specific embodiments of water purification and water line decontamination systems adapted for use in a dental office. It is to be understood that other embodiments of the present invention may be utilized in other applications. [0016] The system of the present invention operates to deliver sanitized water to a workstation, which may be a dental workstation, a beverage dispenser or other food service apparatus, medical equipment, industrial equipment or the like. Within the context of this disclosure, sanitized water is generally understood to be water which is sterilized or which has a very low concentration of microbes therein. In general, water having no more than 200 colony forming units per milliliter (200 CFU/ML) is recognized in the art as being sanitized water. [0017] The system of the present invention is configured to receive water from a conventional source such as a water main, bottled water or the like. The water is sanitized by heat generated by a boiler. The boiler is also operative to generate steam. The sanitized water is conveyed via a delivery line to a workpiece unit such as a dental drill, a dental irrigator or the like. The system of the present invention is configured to include one or more diverter valves which permit steam, as generated by the boiler, to be routed through the water delivery lines. The system can also be adapted to deliver the steam to compressed air lines or other structures. This live steam has been found to be highly effective in removing biofilm and destroying other sources of biocontamination in the delivery system. The system of the present invention is relatively compact and low in cost; and hence can be installed at each dental workstation, or in other such equipment. The system can be activated to sterilize dental irrigators, drill handpieces and the like prior to the treatment of each patient. [0018] [0018]FIG. 1 is a schematic depiction of one system of the type described hereinabove. As will be seen from the figure, the system includes a water inlet line 10 , which may optionally include a water softener unit. The input water is conveyed to a boiler unit 14 where it is heated by a heater 16 . Heating of the water generates steam, and the system is operated so as to assure that heating is carried out at a combination of time and temperature sufficient to produce sanitized water. In the illustrated embodiment, sanitized water is stored in the boiler; although it is to be understood that a separate reservoir for sanitized water may be employed. As illustrated, the system includes a level probe 18 for controlling the water level in the boiler, and further includes a pressure switch 20 and a temperature switch 22 for regulating operation of the boiler. [0019] Preferably, the boiler operates at 1.5 to 2.0 atmospheres of pressure, and is regulated by the pressure control switch 20 . This assures that the water and steam produced by the boiler are at approximately 240° F., which will assure that the water delivered by the boiler is sanitized. The boiler is under constant pressure, which eliminates the need for a delivery pump or other secondary pressure regulation in the delivery lines. [0020] The system includes a sanitized water delivery line 24 and a steam delivery line 26 in communication with the boiler. Both of these lines are in communication with a diverter valve 28 which, as illustrated, is a solenoid operated valve. The diverter valve 28 is also in communication with a fluid delivery line. The diverter valve allows for selectable connection of the steam line 26 or the sanitized water line 24 to the fluid delivery line 30 . [0021] When the system is in operation and the operator is rendering dental services to a patient, sanitized water is delivered from the fluid delivery line 30 to dental irrigators, dental drill handpieces and the like. When it is necessary to resanitize the system, the diverter valve 28 is operated so as to allow the fluid delivery line 30 to be purged with live steam. This flow of steam will remove all biofilm from the line and render the line sanitized. Additionally, the steam will clean workpieces such as irrigators, drill motors and the like. [0022] Still other features of the invention are shown in FIG. 1. For example, dental workstations generally include a compressed air line 27 for powering dental drills, in combination with a water spray. The compressed air line is also coupled to a handpiece used to dry the worksite, remove debris and the like. Typically, compressed air used in dental situations is cold as a result of expansion in the delivery system. In the present invention, a heat exchanger 32 is included for the purpose of transferring excess heat from the sanitized water to the input compressed air. As illustrated, the heat exchanger 32 includes a primary tube in tube exchanger 31 , as well as a secondary heat exchanger 33 which includes a fan 35 having a temperature regulator 37 . In this manner, both the air and water are regulated to provide a comfortable temperature for the patient. [0023] In most preferred embodiments, the boiler will be an electrically heated boiler. It has been found that boilers of the type employed in espresso machines, cappuccino makers and similar coffee brewing apparatus can be readily adapted to the present invention. Such boilers are capable of rapidly generating steam and hot water. They are fairly low in cost, compact and can be incorporated into conventional dental systems. One such boiler having utility in the present invention is available from Lamarzocco International of Seattle, Washington, under the designation WP/I. It is to be understood that other boilers may also be employed in the present invention. In general, the system is operated and configured so that the sanitized water reservoir is maintained at an elevated temperature so as to discourage any further microbial growth. Also, in those instances where the reservoir is integral with the boiler, reservoir size and water usage rates are selected so that fresh water input to the system for the purpose of replacing sanitized water drawn therefrom, does not unduly lower the temperature of the water in the reservoir so as to compromise sanitization. [0024] Referring now to FIG. 2, there is shown another embodiment of the present invention. The FIG. 2 embodiment is generally similar to the FIG. 1 embodiment, and like structures will be referred to by like reference numerals. The FIG. 2 embodiment differs from that of FIG. 1 in that it also includes a chemical dispenser unit therein. As shown in FIG. 2, the system is operative to deliver a material, such as a chemical biocide, surfactant, detergent, or the like into the fluid delivery line 30 of the system. The chemical agent is contained in a dispenser reservoir 34 which communicates with the steam delivery line 26 via a steam ejector 36 . As is known in the art, a steam ejector operates on the venturi effect to draw material from the reservoir 34 into the steam delivery line 26 . The system may include a shutoff valve 39 and a metering orifice 41 to control the flow of the chemical agent. A system of this type may be preferably employed in those instances where the system of the present invention is being retrofit onto equipment having very high levels of biofilm contamination. In such instance, the chemical agent may be employed for initial cleanings, after which steam cleaning will suffice. [0025] Referring now to FIG. 3, there is shown another embodiment of the present invention which is configured for use with a dental unit workstation. The system of FIG. 3 is generally similar to the system of FIG. 1, and like structures will be referred to by like reference numerals; however, the system of FIG. 3 is further operative to sanitize a compressed air line of a dental workstation and to temperature control the air delivered thereby. [0026] In the system of FIG. 3, water enters through a water inlet 10 which has a water softener and/or filter cartridge 12 associated therewith. Flow of inlet water may optionally be controlled by means of a solenoid 40 , or by a valve or the like. In this embodiment, the input water is warmed in a tube in tube heat exchanger 31 which is also in fluid communication with the sanitized water outlet line 24 of the system. The input water enters the boiler 14 and is heated by the heater 16 to produce steam and sanitized water as discussed hereinabove. As further discussed with reference to the previous embodiments, the boiler has a pressure gauge and switch 20 and water level probe 18 associated therewith to control the operation of the boiler. As further shown in this embodiment, the system includes a pressure relief valve 42 to prevent accidental over pressurization of the boiler 14 . The system may also include a vacuum relief valve 44 . The vacuum relief valve 44 functions to relieve any vacuum which is created when the boiler is shut off and allowed to cool from its operating temperature. Cooling of the boiler will cause steam to condense thus creating a potential vacuum. Since the system has been designed for pressure operation, the vacuum could damage the boiler or other components of the system; or it could cause the suck-back of water through the delivery lines, if a pressure relief valve 44 is not included. [0027] The FIG. 3 system also includes a compressed air input line 46 which can be placed in communication with an air compressor, compressed air tank or the like. Compressed air from the air input line 46 passes through a heat exchange coil 47 disposed within the boiler 14 and is warmed. The warmed air passes through an air delivery line 48 and through a heat exchanger 33 b which includes a thermostatted fan 35 b and which operates to temper the heated air to a patient-acceptable temperature. The temperature controlled air then passes through a diverter valve 50 , which in this instance is a solenoid operated valve generally similar to the diverter valve 28 previously described. The steam output line 26 is also in communication with this diverter valve 50 , and as will be appreciated, operation of the diverter valve 50 will selectably permit passage of either steam or tempered air therethrough to an air delivery line 52 which is in communication with the dental workstation. In this manner, the system may be employed to sanitize the air delivery portion of the dental unit. [0028] The FIG. 3 system further includes a first flow switch 54 which is disposed in the air delivery line 48 , and a second flow switch 56 which is disposed in the sanitized water delivery line 24 . These flow switches 54 , 56 operate to activate their respective fans 35 a, 35 b when air or water is flowing so as to provide temperature control. In this embodiment, the sanitized water line also includes a temperature responsive switch 58 which halts the flow of water if the temperature is outside of a predetermined range. As further illustrated, a steam control solenoid valve 60 is disposed in the steam delivery line. This provides backup control of steam delivery and increases the safety level of the system. The FIG. 3 embodiment also includes a manually operated drain valve 62 disposed in the sanitized water output line. This valve facilitates draining and cleaning of the boiler. Another solenoid control valve 64 is disposed in the sanitized water line 24 , and provides backup control of water delivery. [0029] Yet other modifications and variations of the FIG. 3 system may be implemented. For example, the system may further include the chemical agent dispenser of the FIG. 2 embodiment. Also, the system may be further reconfigured to allow for steam sanitization of yet other lines and equipment. [0030] [0030]FIG. 4 is a schematic depiction of the electrical control system of the FIG. 3 embodiment. [0031] It is to be understood that yet other modifications and variations of the present invention may be implemented in view of the teaching presented herein. All of such embodiments are within the scope of the present invention. Also, while the invention has been described with specific reference to a dental system, it is to be understood that systems of this type may be employed for other medical related purposes as well as for food service uses and industrial applications. For example, the systems of the present invention may be incorporated into dialysis units, medical irrigators, beverage dispenser systems, water coolers, food preparation equipment, semiconductor processing lines, machine tools and the like. Also, the systems of the present invention can be employed to clean oil lines, fuel lines and other such industrial equipment wherein biofilm buildup is a problem. [0032] The foregoing drawings, discussion and description are illustrative of specific embodiments of this invention, but are not meant to be limitations to the practice thereof. It is the following claims, including all equivalents thereof, which define the scope of the invention.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a novel solubilizing composition, its liquid and powder formulations, its liquid and powder formulations containing pharmaceutical compounds, and the preparation method thereof wherein said solubilizing composition comprises 9˜90% by weight of at least one selected from the monoglycerides, 0.01˜90% by weight, of at least one emulsifier, and 0˜90.9% by weight of an organic solvent. 2. Description of the Related Art Solubilization of materials can be applied to a variety of fields. In chemical processing where their catalysts, reactants, intermediates, etc. are water-insoluble materials, the solubilization of these materials will affect the yield and the direction of a given reaction. Numerous pharmaceutical compounds with good physiological activities are known to be insoluble in water and thus they have relatively low bioavailabilities. Because the solubilization of these pharmaceutical compounds can simplify administration routes and increase pharmaceutical effects, the solubilization technology is essential in commercializing water-insoluble pharmaceuticals, and therefore extensive worldwide studies have been focused on developing the solubilization technology. Cyclosporin and paclitaxel (Taxol®), for instance, are good Examples of water-insoluble pharmaceutical compounds that cannot be administered alone due to their low solubilities. The solubilizing technology, therefore, has been developed simultaneously with the development of these pharmaceutical compounds themselves. Cyclosporin and paclitaxel are commercially available as pre-concentrates of Cremophor emulsion. These formulations can spontaneously form microemulsion upon dispersion in water (U.S. Pat. No. 5,438,072). In general, solubilizing formulations include emulsion or liposome, which uses lipid as a medium, and a polymeric nanoparticle or polymeric micelle, which uses a polymer as a medium (Langer, R. Nature, 392, 5-10, 1998). Of these, the formulations using lipid as a medium are relatively advantageous in that their raw materials are biocompatible and thus they can be widely applied to medical fields including drug delivery systems. In particular, the emulsions are heterogeneous mixture of oil and water by the use of emulsifiers. The oil-in-water type emulsions, composed of oil components dispersed in water, are widely used in solubilizing water-insoluble pharmaceutical compounds. Liposome formulations consist of spherical lipid vesicles with lipid bilayers and water-insoluble pharmaceutical compounds are enclosed within the lipid bilayer. U.S. Pat. No. 5,531,925 discloses Cubosome, another type of formulation using lipid as a solubilization medium, which was first developed by Swedish scientists in early 1990s. Cubosome is prepared by dispersing the hydrated lipid cubic phase in water. The interior of Cubosome comprises cubic phase wherein lipid and water components constitute continuous but separate three-dimensional channels, and there exists an interface between lipid headgroup and water. Therefore, Cubosome could be advantageous over the conventional emulsion type or liposome type formulations, which only allow solubilization of hydrophobic and hydrophilic pharmaceutical compounds, respectively, in that they can solubilize amphiphilic pharmaceutical compounds as well as hydrophobic and hydrophilic pharmaceutical compounds. Cubosomes can be formed by first forming a very viscous liquid cubic phase by adding water and an emulsifier to monoglyceride, and then by dispersing the mixture in water. Cubosome has average particle size of as large as several micrometers in diameter with the aid of emulsifiers. Since it is preferential to have submicron-sized particles for the solubilization of pharmaceutical compounds, it is also possible to obtain submicron-sized particles by applying mechanical forces such as microfluidization. Preparing submicron-sized cubosome particles by means of a mechanical force, however, may result in physicochemical instability of the enclosed materials or the constituting ingredients of the formulations due to high energy and high temperature accompanying the mechanical process. The formulation process may also incur hydrolysis and oxidization of constituting ingredients because the enclosed materials or the constituting ingredients of the formulations may be vigorously mixed with air during the microfluidization process. Moreover, the dispersed cubosomes prepared by the microfluidization process may experience the instability of the dispersion system after a prolonged storage and subsequently result in phase separation due to aggregation of particles. Although cubosome type formulations have adventageous properties as described above over the conventional type of formulations, they also have disadvantages that they cannot encapsulate the thermally labile pharmaceutical compounds. Also, the physical and chemical stability of the formulation need to be improved greatly to provide a successful drug delivery system. SUMMARY OF THE INVENTION After intensive studies to solve the above problems, the inventors of the present invention finally succeeded in preparing a homogeneous liquid formulation comprising monoglycerides, emulsifiers and organic solvents. This liquid formulation can be easily dispersed in water, without using a harsh physical force, to form a dispersion of particles of less than 500 nm. The homogeneous liquid formulation is physically stable since it is a single phase liquid, and also chemically stable since it does not contain water and does not require physical force during the formulation process. The liquid formulation of the present invention, therefore, can be stored for a prolonged period of time. Therefore, the object of the present invention is to provide a novel solubilizing composition, which enables stable solubilization of materials as well as stable long-term storage, and the manufacturing method thereof. Another object of the present invention is to provide a liquid formulation and a powder formulation for said solubilizing composition, and the manufacturing method thereof. Still another object of the present invention is to provide a liquid formulation and a powder formulation for said solubilizing composition to be used in drug delivery system wherein pharmaceutical compounds are added, and the manufacturing method thereof. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a graph that shows the release profile of a liquid formulation containing rifampicin (◯: the present invention, ●: control Group). FIG. 2 is a graph that shows the release profile of a liquid formulation containing bromocresol green (◯: the present invention, ●: control Group). DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a solubilizing composition comprising 9˜90% by weight of at least one monoglyceride, 0.01˜90% by weight of at least one emulsifier, and 0˜90.9% by weight of an organic solvent. The above composition is prepared by dissolving at least one monoglyceride compound and an emulsifier in an organic solvent followed by removing the organic solvent. The monoglyceride compound is preferred to select at least one from saturated or unsaturated C 10 -C 22 monoglycerides. The monoglyceride compound used in the present invention is monoolein, monopalmitolein, monomyristolein, monoeladin, and monoerucin, and more preferably monoolein. The emulsifier is preferred to select from the group consisting of phospholipid, a non-ionic surfactant, an anionic surfactant, a cationic surfactant, and bile acid. The phospholipid is preferred to select from the group consisting of a phosphatidylcholine (PC) and its derivative, a phosphatidylethanolamine (PE) and its derivative, a phosphatidylserine (PS) and its derivative or a polymeric lipid wherein a hydrophilic polymer is conjugated to the lipid headgroup. The non-ionic surfactant is selected from the group consisting of a poloxamer (also known as Pluronic: polyoxyethylene-polyoxypropylene copolymer), a sorbitan ester (Span), a polyoxyethylene sorbitan (Tween) or a polyoxyethylene ether (Brij). The anionic surfactant is selected from the group consisting of a phosphatidylserine (PS) and its derivative, a phosphatidic acid (PA) and its derivative or sodium dodecyl sulfate (SDS). The cationic surfactant is selected from the group consisting of 1,2-dioleyl-3-trimethylammonium propane (DOTAP), dimethyldioctadecylammonium bromide (DDAB), N-[1-(1,2-dioleyloxy)propyl]-N,N,N-trimethylammonium chloride (DOTMA), 1,2-dioleyl-3-ethylphosphocholine (DOEPC) or 3β-[N-[(N′,N′-dimethylamino)ethan]carbamoyl]cholesterol (DC-Chol). The bile acid is selected from the group consisting of cholic acid, its salt and derivatives; deoxycholic acid, its salt and derivatives; chenocholic acid, its salt and derivatives; ursodeoxycholic acid, its salt and derivatives; and lithocholic acid, its salt and derivatives. The organic solvent is preferred to select from the group consisting of alcohol, ethylene glycol, propylene glycol, polyethylene glycol (PEG), dimethylsulfoxide (DMSO) or the mixture of these solvents. The organic solvents such as acetone, chloroform, benzene, toluene, acetonitrile, alcohols or the mixture of these solvents, which dissolve both a lipid emulsifier and a water-insoluble compound, can also be used. Other additives can be added to the above composition to be within 5% by weight and the Examples are fatty acids, fatty acid esters and fatty acid alcohols. The present invention relates to a liquid formulation of the above solubilizing composition. The liquid formulation of the present invention comprises 9˜90% by weight of at least one monoglyceride, 0.01˜90% by weight of at least one emulsifier, and 9˜90.9% by weight of an organic solvent. The above liquid formulation is manufactured by mixing 1˜99% by weight of the above solubilizing composition with 1˜99% by weight of an organic solvent. More specifically, the method of manufacturing the above liquid formulation comprises (a) completely dissolving at least one monoglyceride compound and at least one emulsifier in an organic solvent and removing the organic solvent; and (b) preparing a homogeneous liquid phase by mixing the composition in the above step (a) with an organic solvent. In the above step (a), an organic solvent is preferred to select from the group consisting of alcohol, chloroform, benzene, toluene, acetonitrile or the mixture of these solvents, and more preferably ethanol. In the above step (b), an organic solvent is preferred to select from the group consisting of alcohol, ethylene glycol, propylene glycol, polyethylene glycol (PEG), dimethylsulfoxide (DMSO) or the mixture of these solvents. The organic solvents such as acetone, chloroform, benzene, toluene, acetonitrile, alcohols or the mixture of these solvents, which dissolve both a lipid emulsifier and a water-insoluble compound, can also be used. An Example of manufacturing the above liquid formulation is as follows. First, one or more monoglycerides and one or more emulsifiers are completely dissolved in an organic solvent such as ethanol, and then the solvent is evaporated either by heating at about 40° C. under a nitrogen atmosphere or by applying a low atmospheric pressure. Here, a trace amount of ethanol that may be still present in the mixture does not affect the property of the final formulation. To this viscous liquid, i.e., the solubilizing composition, a solvent such as ethanol, propylene glycol, ethylene glycol, polyethylene glycol, dimethylsulfoxide (DMSO), is added to prepare a homogeneous mixed liquid formulation. The present invention relates to manufacturing of a powder formulation by lyophilizing the dispersion of the above liquid formulation. The above powder formulation is manufactured by dissolving the above liquid formulation, which comprises 9˜90% by weight of at least one monoglyceride compound, 0.01˜90% by weight of at least one emulsifier, and 9˜90.9% by weight of an organic solvent, in excess water followed by lyophilization. More specifically, the method of manufacturing the above powder formulation comprises the steps of (a) dispersing the liquid formulation in excess water; and lyophilizing said dispersed liquid in step (b) by selectively adding a cryoprotectant. A cryoprotectant may be used to prevent the morphological changes of the particles in the dispersion of the above formulation during lyophilization, and it is preferred to add it less than 30% (w/v) to the liquid formulation. Preferred Examples of a cryoprotectant include sugars such as mannitol or trehalose, amino acids such as arginine, and proteins such as albumin. The present invention relates to the utilization of the solubilizing liquid formulation in the drug delivery system for water-insoluble or amphiphilic compounds. In particular, the present invention relates to solubilizing liquid formulations and powder formulations, and the manufacturing method thereof. The solubilizing liquid formulation comprises 9˜90% by weight of at least one monoglyceride compound, 0.01˜90% by weight of at least one emulsifier, 0.001˜50% by weight of a pharmaceutical compound and 9˜90.9% by weight of an organic solvent. The kinds of monoglyceride compound, an emulsifier and an organic solvent are the same as described above. The above solubilizing formulations can enclose a hydrophilic, a hydrophobic and an amphiphilic compound as a pharmaceutical compound. Examples of these pharmaceutical compounds that can be used in the present invention are antivirals, steroidal anti-inflammatory drugs (SAID), non-steroidal anti-inflammatory drugs (NSAID), antibiotics, antifungals, vitamins, hormones, retinoic acid, prostaglandins, prostacyclins, anticancer drugs, antimetabolitic drugs, miotics, cholinergics, adrenergic antagonists, anticonvulsants, antianxiety agents, major tranquilizers, antidepressants, anesthetics, analgesics, anabolic steroids, estrogens, progesterones, glycosaminoglycans, polynucleotides, immunosuppressants and immunostimulants. In particular, pharmaceutical compounds such as cyclosporin A and paclitaxel, an immunosuppressant and an anticancer drug, which are generally hard to be solubilized can be readily solubilized in the present invention. The solubilizing liquid formulations containing the above-mentioned pharmaceutical compounds can enclose 5% by weight or less of other conventional additives including fatty acids and ester derivatives thereof and alcohol derivatives thereof. The method of manufacturing solubilizing liquid formulations containing the above-mentioned pharmaceutical compounds comprises (a) dissolving at least one monoglyceride compound, at least one pharmaceutical compound and at least one emulsifier in an organic solvent and removing the organic solvent; and (b) preparing a homogeneous liquid phase by mixing the composition in the above step (a) with an organic solvent. In the above step (a), the preferred organic solvents are alcohol, chloroform, benzene, toluene, acetonitrile or the mixture of these solvents, and more preferably ethanol. In the above step (b), the preferred organic solvents are alcohol, ethyleneglycol, propylene glycol, polyethyleneglycol, dimethylsulfoxide (DMSO) or the mixture of these solvents. The organic solvents such as acetone, chloroform, benzene, toluene, acetonitrile, alcohols or the mixture of these solvents, which dissolve both a lipid emulsifier and a water-insoluble compound, can also be used. An Example of manufacturing the above liquid formulation is as follows. First, a monoglyceride compound and an emulsifier are completely dissolved in a solvent such as ethanol and then the solvent is evaporated either by heating at about 40° C. under a nitrogen atmosphere or by applying low atmospheric pressure. Here, a trace amount of ethanol that may be still present in the mixture does not affect the property of the final formulation. To this viscous liquid, in other words, the solubilizing composition, is added with an equal amount of solvent such as ethanol, ethylene glycol, propylene glycol, polyethylene glycol, dimethylsulfoxide (DMSO), and a homogeneous mixed liquid formulation is finally prepared. The present invention is related to manufacturing of a water-insoluble solubilizing powder formulation containing a pharmaceutical compound by lyophilization of the dispersion prepared with the above solubilizing liquid formulation containing water-insoluble materials. The above powder formulation comprises. The method of manufacturing the above powder formulation comprises the steps of (a) dispersing the liquid formulation comprising 9˜90% by weight of at least one monoglyceride compound, 0.01˜90% by weight of at least one emulsifier, 0.001˜50% by weight of a pharmaceutical compound and 9˜90.9% by weight of an organic solvent in excess water; and lyophilizing said dispersed liquid in step (b) by selectively adding a cryoprotectant. A cryoprotectant may be used to prevent the morphological changes in the dispersion of the above formulation during lyophilization, and it is preferred to add it less than 30% (w/v) to the liquid formulation. Preferred Examples of a cryoprotectant include sugars such as mannitol or trehalose, amino acids such as arginine, and proteins such as albumin. The above formulation of the present invention can be easily dispersed in water mediated by such a minimal mechanical aid as a simply shaking with hands. The size of particles is approximately 200˜500 nm in general and varies depending on the property of a given pharmaceutical compounds or an emulsifier. Moreover, the constituting ingredients of and pharmaceutical compound in the particles are not degraded since a strong mechanical force is not required in generating the particles. The formulations according to the present invention can be stored at room temperature in a sealed state for a long period of time without undergoing phase separation or the change in properties of the formulations. When a long-term storage is required, the powder formulation is desirable because it does not contact with an organic solvent or moisture. The formulations according to the present invention are useful in drug delivery system because they exhibit a sustained drug release pattern (FIGS. 1 and 2 ). When applying these formulations in drug delivery system, it is preferred to use various administration routes including intravenous injection, mucosal administration, buccal administration and nasal administration, and more preferably an oral administration. This invention is explained in more detail based on the following Examples but they should not be construed as limiting the scope of this invention. EXAMPLE 1 Liquid Formulation Manufactured According to the Change in the Amount of an Emulsifier (1) (1) Manufacturing Solubilizing Composition One hundred milligrams of monoolein and 15, 20, 25, 30, 35 and 40 mg each of Pluronic F-127 were added to about 1 mL of ethanol and dissolved completely. Ethanol in the mixture was evaporated by stirring under nitrogen atmosphere or by applying low pressure. Trace amount of ethanol still remaining in the above mixture did not affect the manufacturing of formulations. (2) Manufacturing Liquid Formulation In the prepared solubilizing compositions in the above step (1), 115, 120, 125, 130, 135 and 140 mg of ethanol, respectively, was added so that the final concentration of the ethanol in the resulting mixture can be about 50% (w/w). The mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. (3) Property Analysis of thus Prepared Liquid Formulation The size of the emulsion particles were measured by using Malvern Zetasizer (Malvern Instruments Limited, England) after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. An average particle size and polydispersity was obtained by measuring a given formulation three times (Orr, Encyclopedia of emulsion technology, 1, 369-404, 1985). This method was used in measuring the particle size and the polydispersity throughout the following Examples. The above liquid formulations were dispersed well in water, and the average particle size was about 250 nm in diameter. Meanwhile, each of the solubilizing compositions manufactured the same as in the above step (1) of Example 1 as a control group was added with an excessive amount of distilled water in place of an organic solvent. As a result, a gel with a strong viscosity was formed, and also shown to have an isotropic structure when observed under a polarized light microscope. Determination of the particle size was not possible because the formulation was not dispersed in water. Rather, the formulation formed a viscous gel that floats in water. EXAMPLE 2 Liquid Formulation Manufactured According to the Change in the Amount of an Emulsifier (2) The liquid formulations and dispersed liquid were prepared the same as in the step (1) of the Example 1 and their particle size and polydispersity were measured by the same methods in the Example 1 with the exception that 115, 120, 125, 130, 135 and 140 mg of PEG400, respectively, was added instead of ethanol to the solubilizing compositions obtained in the above step (1) so that the final concentration of the PEG400 in the resulting mixture can be about 50% (w/w). In this case, the above formulations were dispersed well in water, and the particle size was about 250 nm. EXAMPLE 3 Liquid Formulation Manufactured According to the Change in the Amount of an Emulsifier (3) The liquid formulations and dispersed liquid were prepared the same as in the step (1) of the Example 1 and their particle size and polydispersity were measured by the same methods in the Example 1 with the exception that 269, 280, 292 and 303 mg of propylene glycol, respectively, was added instead of ethanol to the solubilizing compositions obtained in the above step (1) so that the final concentration of the PEG400 in the resulting mixture can be about 70% (w/w). In this case, the above formulations were dispersed well in water and the particle size was about 350 nm. The results of the Examples 1-3 are summarized in the following Table 1. TABLE 1 Solvents Propylene Pluronic Water(control) Ethanol PEG400 glycol F-127 (mg) Average Particle Size (nm)/Polydispersity 15 Not dispersed 258.0/0.123 278.0/0.290 312.1/0.257 20 Not dispersed 254.4/0.069 249.3/0.219 399.1/0.996 25 Not dispersed 259.3/0.345 277.9/0.428 351.3/0.320 30 Not dispersed 262.7/0.376 246.1/0.611 336.8/0.356 35 Not dispersed 274.7/0.367 248.1/0.071 — 40 Not dispersed 288.8/0.167 262.2/0.396 — As a result, the formulations did not dissolve in water when an organic solvent was not added to the liquid formulations, and the formulations according to the present invention can be easily dispersed into particles less than 400 nm. EXAMPLE 4 Liquid Formulation Manufactured According to the Change in the Amount of a Solvent (1) (1) Manufacturing Solubilizing Composition Ten milligrams of monoolein and 1.5 mg of Pluronic F-127 were added to about 0.1 mL of ethanol and dissolved completely. The ethanol in the mixture was evaporated by stirring under nitrogen atmosphere or by applying low pressure. Trace amount of ethanol still remaining in the above mixture did not affect the manufacturing of formulations. (2) Manufacturing Liquid Formulation In each of the prepared 11.5 mg of solubilizing compositions in the above step (1), 6.25, 9.5, 14.5, 22.0, 34.0, 57.5, and 129.5 μL of ethanol was added so that the final concentration of the ethanol in the resulting mixture can be about 50% (w/w). The mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. Three milliliters of distilled water was added to 2 μL of thus obtained liquid formulation and mixed well by shaking. The size of the particles as well as polydispersity of the dispersion was determined. The above liquid formulations were well dispersed in water when more than 9.5 μL of ethanol was added in liquid formulation with the average particle size of about 250 nm, whereas liquid formulations were not well dispersed in water when 6.25 and 9.5 μL of ethanol were added in the liquid formulation. Meanwhile, each of the solubilizing compositions manufactured the same as in the above step (1) of Example 4 as a control group was added with an excessive amount of distilled water in place of ethanol. As a result, a gel with a strong viscosity was generated and it was shown to have an isotropic structure when observed under a polarized light microscope. In this case, the measurement of a particle size was not possible because the formulation was not dispersed in water. EXAMPLE 5 Liquid Formulation Manufactured According to the Change in the Amount of a Solvent (2) The liquid formulations and dispersed liquid were prepared the same as in the step (1) of the Example 4 and their particle size and polydispersity were measured by the same methods in the Example 4 with the exception that 14.5, 22.0, 34.0, 57.5, and 129.5 μL of PEG400, respectively, was added instead of ethanol to each 11.5 mg of the solubilizing compositions obtained in the above step (1). In this case, the above formulations were well dispersed in water and the particle size was about 300 nm. EXAMPLE 6 Liquid Formulation Manufactured According to the Change in the Amount of a Solvent (3) The liquid formulations and dispersed liquid were prepared the same as in the step (1) of the Example 4 and their particle size and polydispersity were measured by the same methods in the Example 4 with the exception that 14.5, 22.0, 34.0, 57.5, and 129.5 μL of propylene glycol, respectively, was added instead of ethanol to each 11.5 mg of the solubilizing compositions obtained in the above step (1). In this case, the above formulations were well dispersed in water and the particle size was about 300 nm. The results of the Examples 4-6 are summarized in the following Table 2. TABLE 2 Solvents Propylene Amount of Ethanol PEG400 glycol Solvent (μL) Average Particle Size (nm)/Polydispersity 0 (control) Not dispersed Not dispersed Not dispersed 6.25 Not dispersed — — 9.5 Not dispersed — — 14.5 253.6/0.191 278.0/0.290 Not dispersed 22.0 254.4/0.105 288.4/0.377 Not dispersed 34.0 271.9/0.175 294.2/0.393 312.1/0.257 57.5 296.7/0.246 268.0/0.378 295.3/0.222 129.5 296.8/0.191 310.3/0.394 284.8/0.224 EXAMPLE 7 Liquid Formulation Manufactured According to the Change in the Amount of an Emulsifier (4) (1) Manufacturing Solubilizing Composition One hundred milligram of monoolein and 15, 20, 25, 30, 35 and 40 mg each of PEG 2000 PE were added to about 1 mL of ethanol and dissolved completely. Ethanol in the mixture was evaporated by stirring under nitrogen atmosphere or by applying low pressure. Trace amount of ethanol still remaining in the above mixture did not affect the manufacturing of formulations. (2) Manufacturing of Liquid Formulations and Property Analysis In the solubilizing compositions in the above step (1), 115, 120, 125, 130, 135 and 140 mg of ethanol was added so that the final concentration of the ethanol in the resulting mixture can be about 50% (w/w). The mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above liquid formulations were well dispersed in water when more than 20 mg of PEG 2000 PE was added in liquid formulation with the average particle size resulted of about 350 nm, whereas liquid formulations were not dispersed well in water when less than 20 mg of PEG 2000 PE was added. Meanwhile, each of the solubilizing compositions manufactured the same as in the above step (1) of Example 7 as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed well in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 8 Liquid Formulation Manufactured According to the Change in the Amount of an Emulsifier (5) The liquid formulations and dispersed liquid were prepared the same as in the step (1) of the Example 7 and their particle size and polydispersity were measured by the same methods in the Example 7 with the exception that PEG400 was added as an organic solvent in place of ethanol. When the PEG400 was added less than 15 mg the formulations were not dissolved in water. When more than 15 mg of PEG400 was added, the above formulations were well dispersed and the particle size was about 400 nm. EXAMPLE 9 Liquid Formulation Manufactured According to the Change in the Amount of an Emulsifier (6) The liquid formulations and dispersed liquid were prepared the same as in the step (1) of the Example 7 and their particle size and polydispersity were measured by the same methods in the Example 7 with the exception that 269, 280, 292, 303, 315 and 327 mg of propylene glycol, respectively, was added as an organic solvent in place of ethanol. In this case, all the liquid formulations were well dispersed regardless of the amount of propylene glycol and the resulting particle size was about 350 nm. The results of the Examples 7-9 are summarized in the following Table 3. TABLE 3 Solvents Propylene PEG 2000 PE Water(control) Ethanol PEG400 glycol mg) Average Particle Size (nm)/Polydispersity 15 Not dispersed Not Not 346.1/0.533 dispersed dispersed 20 Not dispersed Not 421.8/0.579 365.6/0.404 dispersed 25 Not dispersed 373.3/0.643 390.5/0.316 381.0/0.443 30 Not dispersed 344.2/0.689 435.8/0.659 367.9/0.341 35 Not dispersed 363.7/0.292 405.7/0.801 340.7/0.473 40 Not dispersed 377.5/0.545 397.8/0.511 370.9/0.606 EXAMPLE 10 Liquid Formulation Manufactured According to the Change of an Emulsifier (1) One hundred milligrams of monoolein and 20 mg of Pluronic F-68 were added into about 1 mL of ethanol, dissolved completely and then solubilizing composition was obtained by removing the ethanol as described in the Example 1. After adding 120 mg of ethanol into the solubilizing compositions in the above step (1), the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size was 287.3 nm and the polydispersity was 0.273. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 11 Liquid Formulation Manufactured According to the Change of an Emulsifier (2) One hundred milligrams of monoolein and 20 mg of Pluronic F-68 were added into about 1 mL of ethanol, dissolved completely and then solubilizing composition was obtained by removing the ethanol as described in the Example 1. After adding 120 mg of propylene glycol into the solubilizing compositions in the above step (1), the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size particle size was 265.0 nm and the polydispersity was 0.259. EXAMPLE 12 Liquid Formulation Manufactured According to the Change of an Emulsifier (3) Solubilizing composition was manufactured as in the Example 10 with the exception that 15 mg of dinonanoylphosphatidylcholine (DNPC) was added in place of Pluronic F-68, and liquid formulation was subsequently obtained by adding ethanol to the solubilizing composition. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size particle size was 505.0 nm and the polydispersity was 0.422. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 13 Liquid Formulation Manufactured According to the Change of an Emulsifier (4) Solubilizing composition was manufactured as in the Example 10 with the exception that 20 mg of Tween 20 was added in place of Pluronic F-68, and liquid formulation was subsequently obtained by adding ethanol to the solubilizing composition. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size particle size was 264.5 nm and the polydispersity was 0.476. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed well in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 14 Liquid Formulation Manufactured According to the Change of an Emulsifier (5) Solubilizing composition was manufactured as in the Example 10 with the exception that 20 mg of Tween 80 was added in place of Pluronic F-68, and liquid formulation was subsequently obtained by adding ethanol to the solubilizing composition. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size particle size was 234.0 nm and the polydispersity was 0.305. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 15 Liquid Formulation Manufactured According to the Change of an Emulsifier (6) Solubilizing composition was manufactured as in the Example 10 with the exception that 20 mg of cremophor EL (EL) was added in place of Pluronic F-68, and liquid formulation was subsequently obtained by adding ethanol to the solubilizing composition. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size was 218.4 nm and the polydispersity was 0.330. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 16 Liquid Formulation Manufactured According to the Change of an Emulsifier (7) Solubilizing composition was manufactured as in the Example 10 with the exception that 20 mg of dioleyltrimethylammoniumpropane (DOTAP) was added in place of Pluronic F-68, and liquid formulation was subsequently obtained by adding ethanol to the solubilizing composition. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed the average particle size particle size was 397.1 nm and the polydispersity was 0.439. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. The results of the Examples 10-16 are summarized in the following Table 4. TABLE 4 Emulsifier Organic Solvent Particle size (nm) Polydispersity Pluronic F-68 Ethanol 287.3 0.273 Propylene Glycol 265.0 0.259 DNPC Ethanol 505.0 0.422 Tween 20 Ethanol 264.5 0.476 Tween 80 Ethanol 234.0 0.305 Cremophor EL Ethanol 218.4 0.330 DOTAP Ethanol 397.1 0.439 Control Group* Not dispersed *All the control groups (when solubilizing compositions were to be directly dispersed in water) were not dispersed regardless of the kind of an emulsifier being used. EXAMPLE 17 Liquid Formulation Manufactured According to the Use of a Composite Emulsifiers (1) (1) Manufacturing Solubilizing Composition Sixty-five milligrams of monoolein, 35 mg of egg phosphatidyl choline (lecithin, PC) and 10 mg of Pluronic F-127 were added to about 1 mL of ethanol and dissolved completely. The above mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. Trace amount of ethanol still remaining in the above mixture did not affect the manufacturing of formulations. (2) Manufacturing of Liquid Formulations and Property Analysis After adding 120 mg of ethanol into the solubilizing compositions in the above step (1), the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 351.6 nm and the polydispersity was 0.505. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. The average particle size was about 2117.1 nm and the polydispersity was 1.000. EXAMPLE 18 Liquid Formulation Manufactured According to the Use of Composite Emulsifiers (2) One hundred milligrams of monoolein, 15 mg of PEG 2000 PE and 15 mg of dimyristylphosphatidylcholine (DMPC) were added to about 1 mL of ethanol and manufactured the solubilizing composition as in the Example 17. After adding 120 mg of ethanol into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 486.7 nm and the polydispersity was 0.190. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. EXAMPLE 19 Liquid Formulation Manufactured According to the Use of A Composite Emulsifiers (3) One hundred milligrams of monoolein, 15 mg of Pluronic F-127 and 15 mg of Tween 20 were added to about 1 mL of ethanol and manufactured the solubilizing composition as in the Example 17. After adding 120 mg of ethanol into the solubilizing compositions, the mixture was shaken manually or set aside be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 275.8 nm and the polydispersity was 0.223. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. The results of the Examples 17-19 are summarized in the following Table 5. TABLE 5 Average Particle Size (nm)/ Polydispersity No Ethanol Solubilizing Added (Control Example Composition Ethanol Added Group) 17 Monoolein:  65 mg 351.6/0.505 2117.1/1.000 Pluronic F-127:  10 mg Egg PC:  35 mg 18 Monoolein: 100 mg 486.7/0.190 Not dispersed PEG 2000 PE:  15 mg DMPC:  15 mg 19 Monoolein: 100 mg 275.8/0.223 Not dispersed Pluronic F-127:  15 mg Tween 20:  15 mg EXAMPLE 20 Manufacturing of Liquid Formulation Containing Non-aqueous Compound Three identical solubilizing compositions comprising 10 mg of monoolein, 2 mg of Pluronic F-127, 0.2 mg of oleyl alcohol and about 0.1 mL of ethanol were manufactured as in the Example 1. After adding 13 mg of ethanol, propylene glycol or PEG 400 into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results of the average particle size and the polydispersity measured are shown in the following Table 6. Meanwhile, the solubilizing composition manufactured the same as in the above as a control group was added with an excessive amount of distilled water. The resulting gel had a strong viscosity and was not dispersed in water and also shown to have an isotropic structure when observed under a polarized light microscope. TABLE 6 Average Particle Size Solvent used (nm) Polydispersity Control Group Not dispersed Not dispersed Ethanol 202.8 0.227 Propylene Glycol 218.1 0.210 PEG 400 209.5 0.127 EXAMPLE 21 Manufacturing of Liquid Formulation Containing a Pharmaceutical Compound (1) One hundred milligrams of monoolein, 20 mg of Pluronic F-127 along with 0.5 mg of bromocresol green, were added to about 1.4 mL of ethanol to manufacture the solubilizing composition as in the step (1) of the Example 1. After adding 130 mg of ethanol into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 283.1 nm and the polydispersity was 0.583. EXAMPLE 22 Manufacturing of Liquid Formulation Containing a Pharmaceutical Compound (2) One hundred milligrams of monoolein, 20 mg of Pluronic F-127 along with 0.5 mg of rifampicin, were added to about 1.4 mL of ethanol and manufactured the solubilizing composition as in the step (1) of the Example 1. After adding 130 mg of ethanol into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 321.3 nm and the polydispersity was 0.367. EXAMPLE 23 Manufacturing of Liquid Formulation Containing a Pharmaceutical Compound (3) One hundred milligrams of monoolein, 20 mg of Pluronic F-127 along with 2 mg of bupivacaine were added to about 1.4 mL of ethanol and manufactured the solubilizing composition as in the step (1) of the Example 1. After adding 130 mg of ethanol into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 317.6 nm and the polydispersity was 0.563. EXAMPLE 24 Manufacturing of Liquid Formulation Containing a Pharmaceutical Compound (4) One hundred milligrams of monoolein, 20 mg of Pluronic F-127 along with 1 mg of paclitaxel were added to about 1.4 mL of ethanol and manufactured the solubilizing composition as in the step (1) of the Example 1. After adding 130 mg of ethanol into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. The size and polydispersity of the emulsion particles were measured after diluting the emulsion by adding 3 mL of distilled water with 2 μL of thus obtained liquid formulation. The above formulation was well dispersed in water and the results showed that the average particle size was 0.329. The results of the Examples 21-24 are summarized in the following Table 7. TABLE 7 Pharmaceutical Average Particle Size Compound (nm) Polydispersity Bromocresol green 283.1 0.583 Rifampicin 321.3 0.367 Bupivacaine 317.6 0.563 Paclitaxel 196.6 0.329 As shown in the above Table 7, all of the particles were shown to have a size smaller than 350 nm regardless of the kinds of the pharmaceutical compounds, and thus the formulation of the present invention is proven to solubilize a water-insoluble pharmaceutical compound successfully. EXAMPLE 25 Manufacturing of Powder Formulation via Lyophilization (1) One hundred microliters of liquid formulation manufactured as in the Example 10 was added to 1 mL of 5% trehalose aqueous solution, dispersed by shaking manually and lyophilized to obtain the powder formulation. About 3 mg each of these powder formulations were redispersed in 3 mL of distilled water to measure the particle size and the polydispersity by using the same method in the Example 1. The results showed that the average particle size was 388.0 nm and the polydispersity was 0.386. EXAMPLE 26 Manufacturing of Powder Formulation via Lyophilization (2) One hundred microliters of liquid formulation manufactured as in the Example 11 was added to 1 mL of 5% trehalose aqueous solution, dispersed by shaking manually and lyophilized to obtain the powder formulation. About 3 mg each of these powder formulations were redispersed in 3 mL of distilled water to measure the particle size and the polydispersity by using the same method in the Example 1. The results showed that the average particle size was 395.6 nm and the polydispersity was 0.666. The results of the Examples 25-26 are summarized in the following Table 8. TABLE 8 Composition of Liquid Formulation used in Average manufacturing Powder Particle Example Formulation Size (nm) Polydispersity 25 Monoolein: 100 mg 388.0 0.386 Pluronic F-127:  20 mg Ethanol: 120 mg 26 Monoolein: 100 mg 395.6 0.666 Pluronic F-127:  20 mg Propylene Glycol: 120 mg As shown in the above Table 8, all the particles of the powder formulations were shown to have a size smaller than 400 nm even after redispersion in distilled water, and thus the formulation of the present invention is proven to solubilize a water-insoluble pharmaceutical compound successfully. EXPERIMENTAL EXAMPLE 1 Release Experiment 1 of a Pharmaceutical Compound One hundred and forty milligrams of monoolein, 28 mg of Pluronic F-127 and 0.7 mg of rifampicin, were added to about 1.4 mL of ethanol to prepare the solubilizing composition as in the Example 1. After adding 180 mg of PEG 400 into the solubilizing compositions, the mixture was shaken manually or set aside to be dissolved completely to prepare the liquid formulation. Dispersion was prepared by mixing 250 μL of the above liquid formulation with 1.75 mL of distilled water and shaken manually. The mixture was then added into a dialysis bag (MWCO=3,500, Spectra/Por R , Spectrum Medical Industries, Inc., USA), both ends were tied with a closure, and placed into a 50 ml conical tube containing 10 ml of phosphate buffered saline (PBS, pH=7.4). The conical tube was placed in a 37° C. shaking water bath for the release experiment. The PBS solution located outside the dialysis tube was collected at regular intervals to analyze concentration of the pharmaceutical compound released from the dialysis bag by using Fluorescence spectroscopy (λ ex =370 nm, λ em =480 nm). An aqueous solution where 0.7 mg of rifampicin was dissolved in 2 mL of distilled water was used as a control. The result showed that more than 80% of the drug was released within 5 hr in a control group while the liquid formulation according to the present invention exhibited a sustained release pattern by releasing over 120 hr. EXPERIMENTAL EXAMPLE 2 Release Experiment 2 of a Pharmaceutical Compound Release experiment was performed using the liquid formulation manufactured the same as in the experimental Example 1 with the exception that 0.7 mg of bromocresol green was used in place of rifampicin. The released drug was collected from the PBS solution and subsequently analyzed for its absorbance at 617 nm. An aqueous solution, where 0.7 mg of bromocresol green was dissolved in 2 mL of distilled water, was used as a control. The result showed that more than 80% of the drug was released within 5 hr in a control group while the liquid formulation according to the present invention exhibited a sustained release pattern. The results of the above experiments are summarized in the following Table 9. TABLE 9 Experimental Example Composition of Liquid Formulation Release Pattern 1 Monoolein 140 mg Sustained Release Pluronic F-127  28 mg Rifampicin   0.7 mg Rifampicin   0.7 mg Fast Release 2 Monoolein 140 mg Sustained Release Pluronic F-127   28 mg Bromocresol Green   0.7 mg PEG 400 180 mg Rifampicin   0.7 mg Fast Release EXPERIMENTAL EXAMPLE 3 Stability Test of a Pharmaceutical Compound According to Storage Time (1) The stability of the liquid formulations manufactured according to the Example 1 was tested by measuring the size and polydispersity of the dispersion made from the liquid formulations of the present invention. The formulation was dispersed in water immediately after the preparation and also after storing for 120 days at room temperature for the measurement The results are shown in the following Table 10. TABLE 10 Average Particle Size (nm)/ Polydispersity Immediately After 120 Days after Manufacture Manufacture Liquid Formulation of 254.4/0.069 263.4/0.247 the Present Invention As shown in the above Table 10, the dispersion prepared from the formulation according to the present invention retained small particle size with a narrow distribution both immediately after and 120 days after the preparation. EXPERIMENTAL EXAMPLE 4 Stability Test of a Pharmaceutical Compound According to the Period of Storage (2) Liquid formulations containing rifampicin or bromocresol green were manufactured as in the above experimental Examples 1 and 2. The particle size and the polydispersity of the above manufactured liquid formulations were measured by dispersing them in distilled water immediately after the manufacture, and 30 days or 120 days after the manufacture. The results are shown in the following Table 11. TABLE 11 Composition of Liquid Average Particle Size (nm)/Polydispersity Formulation 0 Day 30 Days 120 Days Monoolein 140 mg 283.1/0.583 329.8/0.669 278.5/0.673 Pluronic F-127   28 mg Bromocresol Green   0.7 mg PEG 400 180 mg Monoolein 140 mg 321.3/0.367 275.1/0.340 245.2/0.345 Pluronic F-127   28 mg Bromocresol Green   0.7 mg PEG 400 180 mg As shown in the above Table 11, the dispersion prepared from the formulation according to the present invention retained small particle size with a narrow distribution both immediately after and 120 days after the preparation. As described above, the formulations according to the present invention can solubilize stably a given pharmaceutical compound and also generate homogeneous particles less than 500 nm when dispersed in water. Moreover, the formulations can be easily dispersed in water without any mechanical aid, and problems such as phase separation, hydrolysis and oxidation can be prevented thus being suitable for use in drug delivery system.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of Ser. No. 786,025, filed Oct. 10, 1985 now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a contradeglutitious solid herbicidal composition (i.e., a herbicidal composition not easy to swallow). More specifically, it relates to a contradeglutitious solid herbicidal composition containing, as a herbicidal agent, a "1,1'-dimethyl-4,4'-bipyridylium" salt (i.e., so-called "paraquat" salt), which is not easily swallowed even if such a paraquat salt solution is accidentally or intentionally drunk. The term "paraquat" used herein means 1,1'-dimethyl-4,4'-bipyridinium cation. 2. Description of the Related Art The importance of herbicides or pesticides in modern agriculture is widely recognized and many herbicides or pesticides are in practical use. Herbicides or pesticides practically used must be registered, after being subjected to a severe examination including the toxicity and safety thereof based on the laws and regulations concerned. Accordingly, as long as herbicides or pesticides are properly used according to instructions for use, they will not harm the human body in any way. However, the present status is such that toxic or poisonous accidents caused by a portion of herbicides or pesticides still occur in spite of the fact that the proper handling of herbicides or pesticides and the preventing of injury thereby to the human body has been taught and the dangers of improper usage have been widely announced for a long time. In particular, a herbicide, a paraquat salt, is widely used because of the strong herbicidal effect and easy applicability thereof, and quite a large number of toxic or poisonous accidents have been caused by the accidental or intentional drinking of the paraquat salt despite clear indications of its toxicity. This is because paraquat has very strong acute toxicity and is commercially available in the form of an aqueous solution having a relatively high concentration. Paraquat is generally marketed as an about 24 W/V % aqueous paraquat dichloride solution. When used, the raw paraquat solution is diluted 300 to 1500 times with water and the resultant diluted paraquat solution is generally sprayed as a weed-killer in an amount of 100 to 150 liters per 10 are (i.e., 100 m 2 ). The oral acute toxicity of paraquat dichloride is an LD 50 of 166 to 217 mg/kg (rat) and it is reported in "Kyukyu Igaku" 4(4), p 399 (1980) that the lethal dose of paraquat for humans is approximately 15 ml of the 20% aqueous paraquat solution (i.e., approximately 3 g of paraquat). On the other hand, it is reported in "Gekkan Yakuji" 25(8), p 147 (1983) that an average amount drunk in one mouthful by an adult human is generally approximately 40 ml. This means that, if a commercially available paraquat solution is accidentally or intentionally drunk, a mouthful of the paraquat solution is sufficient to be lethal to a human. Various attempts have been made to prevent accidental toxic or poisonous injury caused by paraquat. For example, odorants or colorants are mixed into the paraquat solutions to prevent accidental drinking by giving it an unpleasant odor or color. However, this is not effective for infants or against intentional drinking. Furthermore, the inclusion of nauseants in the paraquat solutions has been proposed, to rapidly remove the mistakenly drunk paraquat from the stomach and other digestive system prior to the absorbance of paraquat into the body therethrough. However, it is extremely unfortunate that, at present, once paraquat is swallowed, a reliable and effective curing or treatment method is not available, although this depends upon the amount swallowed, even if the paraquat is vomitted at an early stage. Consequently, although various attempts have been made to solve the above-mentioned problems, an appropriate and effective means has not, as yet, been found. In order to prevent toxic or poisonous accidents caused by the oral intake of paraquat, it is thought that the concentration of commercially available paraquat should be decreased so that a lethal amount is not reached unless a relatively large amount of a paraquat solution is drunk. However, this causes disadvantages in the transportation and storage of paraquat solutions and also impairs the inherent easy handling characteristics of paraquat. On the other hand, it is considered that, when paraquat is marketed in the form of a solid instead of an aqueous solution, the paraquat becomes difficult to drink, toxic or poisonous injuries caused by the accidental intake of paraquat can be prevented, and, furthermore, the transportation and storage thereof are convenient. However, since paraquat is completely soluble in water, an aqueous solution containing a lethal amount of paraquat is easily prepared from such solid paraquat by the addition of, for example, a mouthful of water, and thus it is practically impossible to prevent a person with suicidal intent from taking the poison. SUMMARY OF THE INVENTION Accordingly, the objects of the present invention are to eliminate the above-mentioned disadvantages of paraquat and to provide a contradeglutitious solid herbicidal composition capable of effectively preventing the occurrence of accidents or injuries from acute poisoning caused by an accidental or intentional intake of paraquat, without impairing the essential characteristics, e.g., strong herbicidal effects and easy applicability, of paraquat. Other objects and advantages of the present invention will be apparent from the following description. In accordance with the present invention, there is provided a contradeglutitious solid herbicidal composition comprising a 1,1'-dimethyl-4,4'-bipyridylium salt in a substantially solid state and a thickening agent. DESCRIPTION OF THE PREFERRED EMBODIMENTS According to the present invention, since the herbicidal composition is in a solid form and contains a thickening agent, it is difficult to swallow in the solid form itself and, if an amount of the composition corresponding to a lethal dose to human beings is dissolved in a glass of water, only a non-fluidizable mixture, which is difficult to swallow, is obtained. Of course, the present solid herbicidal composition can be changed to an aqueous solution by diluting the composition with a large amount of water. However, since the paraquat concentration of this diluted solution is very low, a lethal amount cannot be ingested unless a remarkably large amount of the diluted solution is drunk. This is practically difficult and the effects of nauseants can be utilized to decrease the likelihood of death from such ingestion. Furthermore, since the present solid herbicidal composition can be stored and transported in glass and plastic vessels, and since the present solid herbicidal composition can be used on-site by diluting with water, there is no substantial difference between the present solid herbicidal composition and conventional commercially available paraquat solutions in the transportation, handling, and applicability thereof. When diluting the present solid herbicidal composition with a large amount of water for use on-site, the present solid herbicidal composition becomes a low viscosity solution suitable for spraying. Furthermore, the solid herbicidal composition according to the present invention may optionally contain, in addition to the essential paraquat and thickening agent, various conventional ingredients such as colorants, odorants, and nauseants, to further improve the safety thereof. In addition, surfactants and other herbicidal active components also can be included in the present herbicidal composition to improve the herbicidal effects and the applicability of the herbicidal composition. The paraquat usable in the present herbicidal composition is substantially in the form of a solid. Accordingly, 1,1'-dimethyl-4,4'-bipyridylium salts (e.g., dichloride, dibromide, and bismethylsulfate or the complex salts with, for example, manganese, iron, urea, thiourea, p-aminophenol, catechol) in the form of crystals can be directly mixed with the thickening agent. However, the industrially or commercially available aqueous paraquat solutions also can be used in the preparation of the present solid herbicidal composition by adding a water-absorbing inorganic fine powder to form an apparently water-free fluidizable solid paraquat prior to mixing with the thicking agent. Any water-absorbing inorganic fine powder can be used for this purpose so long as the herbicidal effects of the paraquat and the characteristics of the thickening agents are not adversely affected. Examples of such water-absorbing inorganic fine powders are white carbon, diatomaceous earth, finely divided calcium silicate, perlite, calcined kaoline, and zeolite. These can be used alone or in any mixture thereof. There are no critical limitations to the addition amount of the water-absorbing inorganic fine powder, as long as the paraquat solution can be substantially solidified. For example, when an about 40% aqueous paraquat dichloride solution is used, an equal amount or more, based on the amount of the water contained in the paraquat dichloride solution, of the inorganic powder is generally used in the case of, for example, white carbon, finely divided calcium silicate, and perlite, and two times or more, based on the amount of the water contained in the paraquat dichloride solution, of the inorganic powder in generally used in the case of, for example, diatomaceous earth, calcined kaoline, and zeolite. Although there is no critical limitation to the upper limit of the amount of the inorganic powder, generally speaking, the maximum amount of the inorganic powder is ten times the amount of water in the paraquat dichloride solution, mainly from an economical viewpoint. There are no critical limitations to the paraquat concentration of the present solid herbicidal compositions. However, when the paraquat concentration is too low, only a small dilution ratio of the composition with water is required to obtained the desired concentration when spraying on-site and, therefore, spraying tends to become difficult from the standpoint of both the viscosity and the spraying amount, and the efficiency of the transportation and storage also tends to be decreased. On the other hand, when the paraquat concentration in the present herbicidal composition is too high, the above-mentioned problems do not arise but the allowable safety range tends to become small from the point of view of preventing the possible occurrence of toxic or poisonous accidents. For these reasons, the practically preferable concentration range of the paraquat in the present herbicidal compositions is from about 3% by weight to 30% by weight. The thickening agents usable in the present invention are those which are capable of increasing the viscosity or forming the gel with the addition of a relatively small amount of water to the solid herbicidal composition at an ambient temperature in a short period of time. There are no specific limitations to the types of the thickening agents as long as the above-mentioned requirements are fulfilled. Various natural and synthetic thickening agents can be used in the present invention. Typical examples of such thickening agents are alginic acid salts, propylene glycol alginates; carrageenan, guar gum, modified guar gum, xanthan gum, modified xanthan gum, carboxymethyl cellulose salts, methyl cellulose, hydroxyalkyl cellulose, pectine, locust bean gum, carboxymethyl starch salts, pullulan, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid salts, and polyacryl amide. These thickening agents may be used alone or in any mixture thereof. Furthermore, various conventional acids or salts also may be used in the present herbicidal compositions to further improve the gellation or thickening characteristics of the present solid herbicidal composition. The addition of inorganic salts to the present herbicidal composition can further improve the gellation properties of the present herbicidal compositions. There are no definite concentrations of the thickening agents in the present herbicidal compositions since the concentrations largely depend upon the type of thickening agent and the concentration of the paraquat component. As one practical measure, the thickening agent can be used in an amount such that the herbicidal compositions causes gellation, when approximately 3 g (i.e., the above-explained lethal dose of paraquat for humans) or more, in terms of paraquat cation, of the herbicidal composition according to the present invention is diluted with approximately 40 ml of water (i.e., the above-explained average amount drunk in one mouthful by an adult human). That is, when the paraquat concentration of the present solid herbicidal composition is 3% to 30% by weight, the thickening agent can be added in an amount such that all of the composition becomes a high viscous liquid or gel that cannot be easily swallowed when the present herbicidal composition is diluted with a four-tenths (4/10) amount of water in the case of a paraquat concentration of 3%, to 4 times the amount of water in the case of a paraquat concentration of 30%. Furthermore, the concentration of the thickening agent in the present herbicidal composition should be such that the composition becomes an easily sprayable low viscosity liquid when the composition is diluted with water for practical use. Thus, generally speaking, the thickening agent can be added to the present herbicidal composition in an amount such that the composition becomes an easily sprayable low viscosity liquid for practical use, when the composition is diluted with 50 times the amount of water in the case of a paraquat concentration of 3%, to 500 times the amount of water in the case of a paraquat concentration of 30%. More specifically, the concentration of the thickening agent in the present herbicidal concentration is preferably more than 0.5 times but less than 15 times, more preferably 0.6 times to 12 times, of the amount of the paraquat (i.e., cation) in the composition, although the concentration depends upon the type of thickening agent used. The solid herbicidal composition according to the present invention may further contain, as an optional component, conventional colorants, odorants, nauseants, and the like to improve the safety of the paraquat herbicide as well as surfactants and other herbicidal active components to improve the herbicidal effects. However, it should be noted that these optional components should be added in such an amount that the herbicidal effects and the other characteristics of the present composition are not adversely affected. EXAMPLES The present invention will be further explained by, but is by no means limited to, the following Examples and Test Examples. In the Examples, "parts" and "%" are all by weight unless otherwise specified. EXAMPLE 1 to 7 Paraquat wettable powders were prepared by uniformly mixing and grinding solid paraquat components and other ingredients in the following formulation ratios: ______________________________________(1) Paraquat dichloride 25 partsSodium carboxymethyl-starch 75 parts(PRIMOJEL ®: Matsutani Kagaku KogyoCo., Ltd.)(2) Paraquat dichloride 25 partsGuar gum 35 parts(EMCO GUM ® CSA 200/50: MeyhallChemical A.G.)White carbon 40 parts(CARPLEX ® #80: Shionogi & Co., Ltd.,hereinbelow "white carbon")(3) Paraquat dichloride 15 partsPullulan 60 parts(PULLULAN ® PF30: HayashibaraSeibutsukagaku Kenkyusho K.K.)White carbon 20 partsSurfactant (Polyoxyethylene nonylphenyl 5 partsether)(4) Paraquat dichloride 15 partsPolyvinyl pyrrolidone 60 parts(Polyvinyl pyrrolidone PVP K-90:Wako Pure Chemical Industries, Ltd.)White carbon 20 partsSurfactant 5 parts(Polyoxyethylene higher aliphatic alcoholether)(5) Paraquat dichloride 15 partsCarboxymethyl starch 60 parts(Solvitose ® C-5: Matsutani KagakuKogyo Co., Ltd.)White carbon 20 partsSurfactant 5 parts(Polyoxyethylene alkylamine)(6) Paraquat dichloride 25 partsXanthan gum 20 parts(KELZAN ®: Kelco Division of Merck,hereinbelow "Xanthan gum")White carbon 30 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)Foaming agentmalic acid 10 partssodium bicarbonate 10 parts(7) Paraquat dimethylsulfate 30 partsXanthan gum 40 partsWhite carbon 25 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)______________________________________ EXAMPLES 8 to 21 Paraquat wettable powders were prepared by first adding the water-absorbable inorganic fine powder listed below to a concentrated paraquat solution (i.e., aqueous solution containing 37% by weight of paraquat dichloride) to form a solid mixture, followed by the addition of the other ingredients in the following formulation ratios. The resultant mixtures were uniformly mixed and ground. ______________________________________(8) Concentrated paraquat solution 27 partsSodium alginate 45 parts(KELGIN ® HV: Kelco Division of Merck)White carbon 23 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(9) Concentrated paraquat solution 40 partsPropylene glycol alginate 20 parts(KIMIROID ® HV: Kimitsu Kagaku KogyoK.K)White carbon 35 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(10) Concentrated paraquat solution 27 partsCarrageenan 45 parts(TAKARAGEN ® G50: Takagen Corporation)White carbon 23 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(11) Concentrated paraquat solution 40 partsGuar gum 15 parts(EMCO GUM ® CSA 200/50)White carbon 35 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)Nauseant 1 part(Emetine hydrochloride)Odorant 4 parts(β-Phenethyl alcohol)(12) Concentrated paraquat solution 40 partsModified guar gum 15 parts(JAGUAR ® HP-8: Meyhall Chemical AG)White carbon 35 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)Nauseant 1 part(Tartar emetic)β-Phenethyl alcohol 4 parts(13) Concentrated paraquat solution 40 partsXanthan gum 15 parts(KELZAN ®)White carbon 30 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)Anhydrous sodium sulfate 10 parts(14) Concentrated paraquat solution 27 partsSodium carboxymethyl cellulose 45 parts(SUNROSE ® SN 20TC: SanyoKokusaku Pulp Co., Ltd.)White carbon 23 partsSurfactant 4 parts(Polyoxyethylene nonylphenyl ether)(15) Concentrated paraquat solution 50 partsMethyl cellulose 10 parts(MAPOROSE ® M-10000: Matsumoto YushiSeiyaku K.K.)White carbon 36 partsSurfactant 4 parts(Polyoxyethylene nonylphenyl ether)(16) Concentrated paraquat solution 20 partsSodium carboxymethyl starch 57 parts(PRIMOJEL ®)White carbon 18 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(17) Concentrated paraquat solution 27 partsPolyvinyl alcohol 45 parts(PVA 117S: Kuraray Co., Ltd.)White carbon 23 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(18) Concentrated paraquat solution 40 partsPolyacrylamide 24 parts(VISCOMATE ® NS: Showa Denko K.K.)White carbon 31 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(19) Concentrated paraquat solution 27 partsPectin 45 parts(GENU PECTIN BB RAPID SET; theCopenhagen Pectin Factory Ltd.)White carbon 23 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(20) Concentrated paraquat solution 40 partsXanthan gum 14 parts(KELZAN ®)Locust bean gum 10 parts(MEYPRODYN ® 200: Meyhall Chemical AG)White carbon 31 partsSurfactant 5 parts(Polyoxyethylene nonylphenyl ether)(21) Concentrated paraquat solution 40 partsXanthan gum 18 parts(KELZAN ®)Diatomaceous earth 37 parts(RADIOLITE: Showa Kagaku K.K.)Surfactant 5 parts(Polyoxyethylene nonylphenyl ether)______________________________________ EXAMPLE 22 Paraquat wettable granules were prepared as follows. Of the following ingredients, the concentrated paraquat solution used in Examples 8 to 21was mixed with white carbon to form a solid mixture, followed by mixing the other ingredients. The resultant mixture was uniformly mixed and ground, and then granulated by spraying water containing 2% of PVP K-90 in a fluid bed type granulator. ______________________________________Concentrated Paraquat solution 54 partsGuar gum 9 parts(EMCO GUM ® CSA 200/50)White carbon 34 parts(CARPLEX ® #80)Surfactant 3 parts(Polyoxyethylene nonylphenyl ether)______________________________________ The resultant paraquat wettable granules, after drying in the fluid bed, had the following composition. ______________________________________Paraquat dichloride 30 partsGuar gum 14 partsWhite carbon 51.5 partsSurfactant 4.5 parts______________________________________ EXAMPLES 23 to 25 Paraquat wettable powders having the following compositions were prepared by mixing the concentrated aqueous paraquat dichloride solution with white carbon to form a solid mixture. The resultant solid mixture was uniformly mixed with the other ingredients, followed by drying to evaporate the water from the mixture. ______________________________________(23) Paraquat dichloride 35 partsGuar gum 23 parts(EMCO GUM ® CSA 200/50)White carbon 42 parts(24) Paraquat dichloride 35 partsCarrageenan 23 parts(TAKARAGEN: Takagen Corpcration)White carbon 42 parts(25) Paraquat dichloride 35 partsXanthan gum 23 parts(KELZAN ®)White carbon 42 parts______________________________________ TEST EXAMPLE 1 A 30 g amount of the solid composition prepared in Example 1 was mixed with 150 ml of water while stirring so as to obtain a mixture having a paraquat dichloride concentration of 5%. The mixture became pasty shortly after the water was added. Thus, a pasty mixture, which is impossible to swallow, was obtained. On the other hand, the paraquat dichloride composition prepared in Example 1 was diluted with water in such a ratio that 50 g of the effective component was included in 150 liters of the diluted composition. The diluted herbicidal composition thus obtained was sprayed under pressure onto foliage (or stems and leaves) of crabgrass, purple nutsedge, common lambsquarter, pigweed, and barnyard millet, grown in test pots, by using a pressure type atomizer in such an amount that 50 g of the active component per 10 are was applied. Prior to the spraying, a conventional nonionic type spreading agent was added to the herbicidal composition. During the spraying, clogging of the spray nozzle of the atomizer did not occur. When the herbicidal effects were compared with those of commercially available paraquat dichloride solution 5 days after the treatment, no substantial difference was observed. TEST EXAMPLE 2 A 50 g amount of the solid composition prepared in Example 11 was mixed with 150 ml of water while stirring so as to obtain a mixture having a paraquat dichloride concentration of 5%. The mixture became pasty shortly after the water was added. Thus, a pasty mixture, which is impossible to swallow, was obtained. On the other hand, the paraquat dichloride composition prepared in Example 11 was diluted with water in such a ratio that 50 g of the effective component was included in 150 liters of the diluted composition. The diluted herbicidal composition thus obtained was sprayed under pressure onto the foliage of crabgrass, purple nutsedge, common lambsquarter, pigweed, and barnyard millet grown in test pots, by using a pressure type atomizer in such an amount that 50 g of the active component per 10 are was applied. Prior to the spraying, a conventional nonionic type spreading agent was added to the herbicidal composition. During the spraying, clogging of the spray nozzle of the atomizer did not occur. When the herbicidal effects were compared with those of a commercially available paraquat dichloride solution 5 days after the treatment, no substantial difference was observed. TEST EXAMPLE 3 A 50 g amount of the solid composition prepared Example 13 was mixed with 150 ml of water while stirring so as to obtain a mixture having a paraquat dichloride concentration of 5%. The mixture became pasty shortly after the water was added. Thus, a pasty mixture, which is impossible to swallow, was obtained. On the other hand, the paraquat dichloride composition prepared in Example 13 was diluted with water in such a ratio that 50 g of the effective component was included in 150 liters of the diluted composition. The diluted herbicidal composition thus obtained was sprayed under pressure onto the foliage of crabgrass, purple nutsedge, common lambsquarter, pigweed, and barnyard millet grown in test pots, by using a pressure type atomizer in such an amount that 50 g of the active component per 10 are was applied. Prior to the spraying, a conventional nonionic type spreading agent was added to the herbicidal composition. During the spraying, clogging of the spray nozzle of the atomizer did not occur. When the herbicidal effects were compared with those of a commercially available paraquat dichloride solution 5 days after the treatment, no substantial difference was observed. TEST EXAMPLE 4 A 40 g amount of the solid composition prepared in Example 15 was mixed with 150 ml of water while stirring so as to obtain a mixture having a paraquat dichloride concentration of 5%. The mixture became pasty shortly after the water was added. Thus, a pasty mixture, which is impossible to swallow, was obtained. On the other hand, the paraquat composition prepared in Example 15 was diluted with water in such a ratio that 50 g of the effective component was included in 150 liters of the diluted composition. The diluted herbicidal composition thus obtained was sprayed under pressure onto the foliage of crabgrass, purple nutsedge, common lambsquarter, pigweed, and barnyard millet grown in test pots, by using a pressure type atomizer in such an amount that 50 g of the active component per 10 are was applied. Prior to the spraying, a conventional nonionic type spreading agent was added to the herbicidal composition. During the spraying, clogging of the spray nozzle of the atomizer did not occur. When herbicidal effects were compared with those of a commercially available paraquat dichloride solution 5 days after the treatment, no substantial difference was observed. TEST EXAMPLE 5 The herbicidal effects of the paraquat dichloride wettable powders obtained in Examples 23 to 25 were evaluated in an agricultural field. As Reference Examples, a 24% aqueous paraquat dichloride solution and a 32% bialaphos liquid agent were used. The weeds used for the test were crabgrass having a height of 25 to 30 cm, smartweed having a height of 50 cm, common lambsquarter having a height of 50 cm, and pigweed having a height of 25 cm. The area in each test was 1.5 m×2 m (i.e., 3 m 2 ). The diluted herbicidal composition samples containing 0.3% of a surfactant were sprayed by using a pressure type spray atomizer at an active component amount of 0.5 or 1 kg A.I. (i.e., active ingredient)/ha and at a spraying water amount of 1000 l/ha. Six days after the spraying, the herbicidal effects were observed according to the following standard 0 ... No effect 100 ... Complete kill The results are as shown in Table 1. As is clear from the results shown in Table 1, since the grass height at the time of the treatment is relatively large, complete killing was not obtained at a rate of 0.5 kg A.I./ha. However, in the case of 1.0 kg A.I./ha, good results were obtained and there was no substantial difference between the compositions of Examples 23 and 25 and the conventional paraquat dichloride solution. TABLE 1__________________________________________________________________________Sample Rate Weed ControlComposition No. (kg A.I./ha) Crabgrass Smartweed Lambsquarter Pigweed__________________________________________________________________________Example No. 23 0.5 60 93 70 80 1.0 95 95 100 100Example No. 24 0.5 85 85 90 93 1.0 98 100 100 100Example No. 25 0.5 90 90 90 98 1.0 90 100 100 100Paraquat dichloride 0.5 80 75 85 95 1.0 93 98 100 100Bialaphos 0.5 60 93 70 80 1.0 95 90 100 100Control -- 0 0 0 0(No treatment)__________________________________________________________________________

1a

PRIORITY The present application claims priority to U.S. Application 61/210,232 filed on Mar. 16, 2009, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION The present invention relates to auto safety and pet comfort while transporting animals, such as dog(s), cat(s), or other pets. The invention does not restrain the animal, rather it creates a barrier sequestering the animal safely away from the driver. BACKGROUND Pet owners struggle with creating a safe environment for transporting animals. With this in mind, the present invention focuses on sequestering the pet away from the driver (or other passengers) while in transport using a barrier. Unlike items in a similar field, the present invention does not focus on restraint. Of the few items presently available in commerce that create a “barrier”, none of them are as versatile as the present invention. None of them are intended for use in multiple vehicle classes. None of them are adjustable in the sense that they can be used in multiple places within a single vehicle depending on need. None of them assemble and dissemble as quickly and easily, especially without adding any permanent “hardware” to the vehicle itself. BRIEF SUMMARY OF THE INVENTION The objective of the invention is to provide a barrier within a vehicle to improve safety while transporting pets. The barrier of the subject invention is versatile, completely adjustable, easy to use, quick to assemble and dissemble, and convenient to store when not in use. The versatility of the barrier applies to both its positioning and orientation within a single vehicle and its utilization in different types of vehicles. The barrier can be utilized vertically or horizontally, or some combination thereof, to confine a pet to an area in the vehicle away from the driver. Multiple attachment points allow the barrier to be adjusted to the shape necessary to create such separation. The multiple attachment points—on the barrier's perimeter and/or interior—create versatility and adjustability with respect to utilizing the barrier in various types of vehicles and creating multiple possible configurations within a single vehicle. Similarly, the combination of possible materials used for modes of attachment creates a barrier that can be utilized not only in various types of vehicles but also in multiple configurations within a single vehicle. This degree of versatility and adjustability of the subject invention make it unique. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 depicts a barrier comprising a curtain 1 , a reinforced periphery 2 , and a number of grommets 3 located within the periphery. The grommets are arranged with alternating short spacings a and long spacings b. The dotted line F indicates a position along which the barrier could be folded to create a double curtain and allow perfect superpositioning of grommets upon folding. FIG. 2 depicts an hourglass-shaped barrier comprising a drawstring-adjustable opening 4 . Folding along dotted line F allows perfect superpositioning of grommets, and the hourglass shape ensures that the opening 4 is not blocked by the folded material. FIG. 3 shows a top view of fabric folded into one or more Z-folds and stitched with low strength stitching to form a local-failure device. FIG. 4 shows a top view of fabric folded into one or more T-folds and stitched with low strength stitching to form a local-failure device. FIG. 5 illustrates a barrier comprising a buttoned slit 5 . One or more buttons may be unbuttoned to form an opening of variable size within the barrier. FIG. 6 illustrates a barrier comprising a large fixed opening 6 that can accept any of several adaptors 7 a , 7 b , and 7 c to provide a desired size and shape of opening. FIG. 7 depicts a variety of modes of attachment suitable to the invention. FIG. 7A shows a single cord with double hook. FIG. 7B shows a fixed loop with single hook or ball (or other stopper). FIG. 7C shows an adjustable loop with single hook or ball (or other stopper) that can be locked in multiple positions. FIG. 8 provides additional details relating to one embodiment of a Z-fold local-failure device. FIG. 8A shows a top view of a piece of material, webbing, or strapping folded into a Z-fold and stitched. An eye shows the direction of view for a front view. FIG. 8B provides a front view from the perspective of the eye in FIG. 8A and shows a visible pleat line 8 as well as a hidden pleat line 9 resulting from the Z-fold. (The stitching is omitted in FIG. 8B for clarity). FIG. 9 illustrates an embodiment of a barrier incorporating Z-fold local failure devices in the curtain and in an optional reinforced periphery. The barrier contains a number of visible pleat lines 8 resulting from the Z-folds. (Depictions of stitching and hidden pleat lines are omitted). FIG. 10 schematically depicts a barrier 10 and mode(s) of attachment 11 situated in, upon, attached to, or removably associated with packaging 12 . The nature of the packaging 12 and relative placement(s) and/or orientation(s) of barrier 10 and mode(s) of attachment 11 are conventional in the art and are not intended to be conveyed with specificity by this figure. DETAILED DESCRIPTION The subject application describes a vehicle barrier that in one configuration may be used for separating the front seat area from the rest of the vehicle. More generally, the subject application describes a flexible or inflexible barrier having multiple attachment points that allow it to be secured between and at least partially dividing different areas of a vehicle. The subject application describes a specific use for the barrier in confining animals, such as pets, to an area away from the driver. However, it should be understood that the embodiments of the subject invention are applicable to a variety of uses, including containing non-animal objects to an area away from the driver. In one embodiment, shown, for example, in FIG. 1 , a flexible material is utilized as an adjustable curtain. The flexible material may be mesh or solid and may be opaque, transparent, or translucent. Use of a mesh material facilitates viewing the back of the vehicle to monitor pets or other objects therein. Use of a transparent curtain material such as clear plastic (whether mesh or solid) likewise facilitates viewing the back of the vehicle. But in an alternative embodiment, the curtain can comprise an opaque material that reduces or eliminates visual contact between the front and back areas of the vehicle. Optionally, the curtain may be rigid rather than flexible. In one embodiment, the curtain can be manufactured of molded or woven nylon, plastic, polypropylene, rayon, acetate, modacrylic, olefin, acrylic including but not limited to ORLON, polyester, carbon fiber, vinyon, PVDC including but not limited to SARAN, elastane including but not limited to SPANDEX, vinalon, aramid including but not limited to NOMEX, KEVLAR, or TWARON, MODAL, polyethylene or high performance polyethylene including but not limited to DYNEEMA or SPECTRA, PBI (polybenzimidazole fiber), polyphenylene sulfide fibers including but not limited to SULFAR, regenerated cellulose including but not limited to LYOCELL, PLA, M5, PBO or other polyoxazole including but not limited to ZYLON, aromatic polyester including but not limited to VECTRAN (TLCP fiber), DERCLON, acrylonitrile or other synthetic rubber, or other synthetic material, or combinations thereof. In an alternative embodiment, the curtain comprises natural materials, such as cotton, linen, silk, wool, sisal, hemp, latex rubber, or other woven plant or animal fibers, wood, metal, or other natural materials in any combination. Natural and synthetic materials may also optionally be used together in any combination. In one embodiment, material incorporating natural or synthetic elastic strands such as rubber strands may be used. In a further embodiment, the periphery or edges of the curtain are joined to a reinforcement material 2 . The reinforcing material may be any synthetic or natural material, including those materials indicated herein as being suitable for the curtain. In this embodiment, the periphery of the curtain is reinforced with a high strength material capable of withstanding any stretching and pulling that may be encountered when installing the barrier or in confining a pet or object to the desired area of a vehicle. In a specific embodiment, the edges of the curtain are joined to (e.g., enclosed in) a woven nylon webbing material. However, in an alternative embodiment, the edges can be reinforced by folding or rolling the edges around a reinforcing material such as cording or piping. In yet another embodiment, the edges may be reinforced by folding or rolling even without use of a distinct reinforcing material such as cording; the additional layers created by folding or rolling will themselves serve as reinforcement. A person with skill in the art would be able to determine any of a variety of additional devices and methods for reinforcing one or more edges of the curtain. Such variations are contemplated to be within the scope of the subject invention. The barrier's curtain 1 can employ a variety of circumferential shapes and configurations suitable for the intended purpose of separating different areas of a vehicle. In one embodiment, the curtain can comprise a generally rectangular shape. However, in alternative embodiments, the curtain can utilize any of a variety of other shapes, including square, round, oval, trapezoid, triangular, quadrilateral, pentagonal, hexagonal, heptagonal, octagonal, other polygonal, or any other shape. A unique advantage of some embodiments of the barrier of the subject invention is the ability to alter the shape to separate a variety of spaces, for example by folding the barrier and/or utilizing alternative points of attachment. Thus, in a still further embodiment, the barrier can have a combination of straight and curved edges to accommodate an even broader range of uses and vehicles. In one embodiment, the barrier is shaped like an hourglass. In an embodiment, the barrier may incorporate 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more energy-absorbing features designed to reduce peak stresses when the barrier experiences high forces of short duration, such as during a collision. For example, if a heavy animal (or other object) were thrown into a barrier without energy-absorbing features, there would be a risk of barrier failure (and/or anchor failure). When energy-absorbing features are incorporated, the barrier itself (and/or its modes of attachment) can elongate in a controlled manner to decelerate the animal or object over a longer period of time, thus reducing the risk of barrier or anchor failure and reducing the risk of damage to the animal or object due to sudden deceleration. In one embodiment, the material of the barrier curtain can elastically elongate under load by 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, or 200% or more without failing. In one embodiment, the modes of attachment can elastically elongate under load by 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, or 200% or more without failing. In one embodiment, one or more local-failure elements may be used to absorb energy. For example, the curtain itself, or its optional reinforced periphery, or both, may be folded and stitched in a Z-fold or T-fold orientation (or a variation thereof) with low-strength stitching; upon heavy impact, the Z-fold or T-fold stitching will rip out partially or completely while the barrier as a whole maintains its integrity. A great variety of local-failure elements may be used including stitching; snaps, buttons, rivets, hooks, or other fasteners that disengage sequentially; and mated hook-and-loop fabric surfaces (for example in a T-fold or Z-fold). In one embodiment, either the modes of attachment or the barrier material or both are of limited elasticity. While not required, it is especially preferred that local-failure elements be incorporated in such a case. For example, the material of the barrier curtain may optionally be able to elastically elongate under load by less than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, or 200% before failure. Independently, the modes of attachment may optionally be able to elastically elongate under load by less than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, or 200% before failure. The barrier can be removably attached across the vehicle space by a variety of devices and methods. In one embodiment as shown in FIG. 1 , one or more openings are formed within the reinforced edges of the barrier and serve as points of attachment. In a preferred embodiment, grommets 3 , as known to those with skill in the art, are utilized to reinforce the openings, as shown, for example, in several of the figures. In one embodiment, openings are provided at the corners of the curtain. In another embodiment, openings are provided in the corners and at generally equidistant points along one, two, or more edges of the curtain. Openings may also be provided at non-equidistant points along one, two, or more edges of the curtain. In one embodiment, at least some of the openings are spaced at alternating longer and shorter distances. For example, a set of 10 openings along an edge could have sequential spacings of 1-inch, 10-inch, 1-inch, 10-inch, 1-inch, 10-inch, 1-inch, 10-inch, 1-inch. In one embodiment, the shorter spacing(s) are less than 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the length of the adjacent longer spacing(s). In one embodiment, the shorter spacings are approximately equal, within a tolerance of ¼, ½, ¾, 1, 1.25, 1.5, 1.75, or 2 inches or less. In one embodiment, the longer spacings are approximately equal, within a tolerance of ¼, ½, ¾, 1, 1.25, 1.5, 1.75, or 2 inches or less. In one embodiment, the shorter spacings are approximately equal and are less than 0.5, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.25, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 8.25, 8.5, 8.75, 9, 9.25, 9.5, 9.75, or 10 inches, or more. In one embodiment the larger spacings are approximately equal and are about 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.25, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 8.25, 8.5, 8.75, 9, 9.25, 9.5, 9.75, 10, 10.5, 10.75, 11, 11.25, 11.5, 11.75, 12, 12.25, 12.5, 12.75, 13, 13.25, 13.5, 13.75, 14, 14.25, 14.5, 14.75, 15, 15.25, 15.5, 15.75, 16, 16.25, 16.5, 16.75, 17, 17.25, 17.5, 17.75, 18, 18.25, 18.5, 18.75, 19, 19.25, 19.5, 19.75, 20, 20.5, 20.75, 21, 21.25, 21.5, 21.75, 22, 22.25, 22.5, 22.75, 23, 23.25, 23.5, 23.75, or 24 inches, or more. To ensure adjustability of the curtain and allow use in either a horizontal or vertical position, it can be preferable to employ a plurality of openings within two or more edges of the curtain. Thus, in some of the embodiments shown in the figures, at least five reinforced openings are provided within each of two edges of the curtain. This can allow the entire curtain to be extended across the vehicle space. Alternatively, only a portion of the curtain can be utilized to extend across the entire space of the vehicle or only a portion of the vehicle space. In this embodiment, the curtain can be folded or draped such that the excess curtain portion remains free of attachment, or the openings in the unused curtain portion can be aligned and attached with the openings in the used curtain portion, providing a double-curtain, if desired. In an embodiment, any mechanical fastener including but not limited to snaps, hooks, pins, bolts, buttons, or other fastener, in any combination, can take the place of some or all openings to serve as points of attachment on the barrier. In a further embodiment, one or more elastic bands (or other modes of attachment) are utilized to secure the barrier at multiple points utilizing the openings (or other points of attachment). In a specific embodiment, multiple elongated, elastic tie-downs with fixedly attached hooks at either end can be used to wrap around fixtures within the vehicle and attach both hooks to the openings in the barrier. In an alternative embodiment, elongated, elastic tie-downs with fixedly attached hooks at either end can be used to secure the curtain attaching one hooked end to an opening and the other hooked end to various features or structures within the vehicle. The use of removable elastic tie-downs can expedite adjustment of the barrier to a variety of vehicle styles and classes. However, in an alternative embodiment, multiple adjustable straps are utilized to secure the edges of the barrier. In a still further embodiment, a combination of adjustable straps and elastic tie-downs are utilized. In addition, there are a variety of types of clamps, hook styles, snap closures, or other fasteners that can be utilized with the tie-downs, adjustable straps, or similar devices, to attach to the openings in the curtain and/or vehicle features or structures. It is anticipated that a person with skill in the art would be able to devise any of a variety of devices for removably attaching to the openings and/or vehicle structures to secure the barrier's curtain across and/or within the vehicle space. Such alternatives are contemplated to be within the scope of the present invention. As often happens with flexible materials utilized across a space, the upper-most edge can droop or sag. This is particularly prone to happen when the fabric is supported at the distal most edges or corners. Such an effect can be unsightly, but, more importantly, it can alter the effectiveness of the barrier. To reduce or eliminate this effect, the upper edge of the barrier curtain can be further supported by utilizing the front seats themselves or the headrests at the top of the front seats of most vehicles. In one embodiment, one or more elastic and/or adjustable headrest bands are utilized to affix the upper edge of the barrier curtain to one or more headrests. In a specific embodiment, the headrest band can have at least one hook (for example, a single hook) to which both ends of the elastic band is fixedly attached to form an elastic loop. The headrest band can be placed around the headrest or actual seat and at least one hook can then be utilized to attach to an opening in the upper edge of the curtain. In a second embodiment, an elongated, elastic tie-down with hooks or other attachment devices at both ends can be utilized by affixing one end to an opening, wrapping the tie-down around the headrest or seat, and affixing the other end to an opening. In a third embodiment, the headrest band can be utilized in a loop shape with a ball or knob for securing the tie-down. In a similar embodiment, where the curtain is installed behind the back seat separating the “cargo area” from the rest of the vehicle, elastic tie-downs with balls or knobs may be utilized to secure the curtain around the back seat's “headrests”, although such headrests are not necessarily identical to those associated with front seats. Use of headrest bands is not limited to supporting the upper edge of the barrier curtain; in another embodiment, the lower edge of the barrier curtain may be attached to headrest bands and the barrier may be extended upward toward the roof of the vehicle. It should be understood that tie-down assemblies and similar devices are well known in the art. A person having benefit of the subject application and knowledge in the art would be able to determine any of a variety of methods and devices (i.e., modes of attachment) for securing and/or attaching a barrier of the subject invention within a vehicle. Any and all such variations are considered to be within the spirit and scope of the subject invention. For example, modes of attachment may be flat or have a cross-sectional shape that is round, oval, rectangular, I-shaped, square, or of any other shape. Modes of attachment may comprise any type of fiber or material listed herein as appropriate for the barrier and/or optional reinforced periphery. Modes of attachment may connect to the barrier via hook(s); knob(s), ball(s), or other stopper(s); snap(s); clip(s); bolt(s); pin(s); button(s); or any other type of mechanical fastener described herein or known in the art. In one embodiment, a barrier and one, two, three, four, five, six, seven, eight, or more individual modes of attachment are provided in, upon, attached to, or removably associated with packaging. An individual mode of attachment may be, for example, a headrest band or loop with single hook; a headrest band or loop with knob; an elongated elastic tie-down with a hook on each of its two ends; an adjustable strap with 0, 1, 2, or more hooks; or any other mode of attachment described herein. Individual modes of attachment may be provided in any combination. For example, if six individual modes of attachment are provided with packaging, the six modes could be two loops with knob and four elongated elastic tie-downs with hooks on each end. In one embodiment, 1, 2, 3, 4, or more openings of at least 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or more inches in their largest dimension are provided within the barrier. Such openings may be selected from round, oval, square, rectangular, triangular, pentagonal, hexagonal, or any other regular or irregular shape (including a slit), in any combination. In one embodiment, at least one of the openings is partially or fully closable, and may employ zipper(s), button(s), hook(s), snap(s), hook-and-loop fabric, clip(s), drawstring(s), or any other means of closure known in the art. In one embodiment, at least one of the provided openings is adjustable in size. For example, the opening may be adjusted by partial closure via drawstring(s) or other means of closure previously mentioned. Alternatively, a large permanent opening may be provided along with attachable adaptors to reduce the opening to a desired size. For example, an opening of 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or more inches may be provided along with separate (for example, zip-in or button-in) insert(s) to reduce the opening size by 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more inches. The attachable adaptor(s) may be attached by zipper(s), button(s), hook(s), snap(s), hook-and-loop fabric, clip(s), or any other means of closure known in the art. In one embodiment, the opening in the attachable adaptor is an adjustable opening, for example by drawstring(s). In one embodiment, one or more of the openings may be sized (either permanently or by adjustable mechanism) large enough to allow the head of an adult (or juvenile) animal to pass through the opening, but small enough to prevent the shoulders, body, or entire animal to pass through the opening, where the animal is a cat, dog, or other animal, for example a Dachshund, Dalmation, Rottweiler, Pekinese, Shar-Pei, Golden Retriever, Black Lab, Chihuahua, Great Dane, Irish Wolfhound, Cocker Spaniel, Portuguese Water Dog, or other recognized dog or cat breed (see, e.g., dog breeds recognized by the American Kennel Club at akc.org and cat breeds recognized by the Cat Fanciers' Association at cfa.org). While the invention has been particularly shown and described with reference to certain specific embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. The following example is intended to illustrate one particular embodiment and use of the subject invention. It is not intended to be limiting in any way. Example 1 Safety Barrier and Installation in a Full-Size SUV The subject invention is contemplated as a barrier for installation within a vehicle with a curtain comprised of nylon mesh outlined with nylon webbing around the entire perimeter. It is rectangular in shape, and within the outlining webbing on the long sides are installed 5 metal grommets evenly spaced for attachment to the interior of the vehicle. The attachment system consists of two different types of elastic (bungee) cords: 1) single loop cord with hook (or with ball, knob, or other stopper) and 2) single cord with double hook. Two single loop cords with hooks (or with ball, knob, or other stopper) are intended to secure around the driver's and passenger's headrests or actual seats. Four single cords with double hooks are intended to secure in one of two ways, either from grommet to anchor, or from grommet, looping (or curving) around anchor and back to grommet. A single cord with double hook that extends from grommet to anchor and back to grommet may return to the same grommet, an adjacent grommet, or a more distal grommet. Four examples of anchors are: 1) the housing for the seatbelt mechanism (for the front seats) where it joins the wall of the vehicle at approximately head height; 2) the handle common in many vehicles located next to the backseat windows and near the housing for the seatbelt mechanism (for the front seats) where it joins the wall of the vehicle at approximately head height; 3) the housing for the seatbelt mechanism (for the front seats) where it joins the floor of the vehicle on the side of each front seat next to the door; 4) the housing for the seatbelt mechanism (for the front seats) where it joins the floor of the vehicle between the two front seats. ADDITIONAL EMBODIMENTS 1. A barrier comprising a curtain, wherein said curtain comprises a periphery and a plurality of points of attachment situated in said periphery. 2. The barrier of embodiment 1, wherein said periphery is reinforced. 3. The barrier of embodiment 2, wherein said periphery is reinforced with webbing, cording, or piping. 4. The barrier of any preceding embodiment, wherein at least one of the points of attachment is an opening. 5. The barrier of embodiment 4, wherein the opening is reinforced with a grommet. 6. The barrier of any preceding embodiment, further comprising at least one mode of attachment, wherein said mode of attachment is an elongated elastic tie-down or a strap. 7. The barrier of embodiment 6, wherein said at least one mode of attachment is a bungee or elastic band or cord in the form of a loop attached to a single hook, ball, or knob. 8. The barrier of any preceding embodiment, wherein said curtain is flexible. 9. The barrier of any preceding embodiment, wherein said curtain is mesh or opaque. 10. The barrier of any preceding embodiment, wherein said curtain comprises nylon, plastic, polypropylene, cotton, plant fibers, wood, metal, or combinations thereof 11. The barrier of any preceding embodiment, wherein said curtain is rectangular, square, round, oval, or trapezoid. 12. The barrier of any preceding embodiment, wherein said plurality of points of attachment situated in said periphery comprise openings at the corners and at approximately equidistant points along two or more edges. 13. The barrier of any preceding embodiment except 12, wherein said plurality of points of attachment situated in said periphery comprise openings at the corners and at alternating long and short spacings along two or more edges. 14. The barrier of any preceding embodiment, wherein the size of said curtain in its shortest dimension is less than 6, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, or more than 40 inches. 15. The barrier of any preceding embodiment, wherein the size of said curtain in its longest dimension is less than 12, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, or more than 60 inches. 16. The barrier of any preceding embodiment, wherein said curtain is mesh and the mesh is less than ⅛, ⅛, ¼, ⅜, ½, ⅝, ¾, ⅞, 1, 1⅛, 1¼, 1⅜, 1½, 1⅝, 1¾, 1⅞, or 2 or more inches, wherein the mesh size refers to the size of a ball that would fall through the mesh if placed on the mesh. 17. The barrier of any preceding embodiment, wherein the periphery is reinforced with webbing having a width of less than ¼, ¼, ⅜, ½, ⅝, ¾, ⅞, 1, 1⅛, 1¼, 1⅜, 1½, 1⅝, 1¾, 1⅞, or 2 or more inches. 18. The barrier of embodiment 5, wherein said grommet has an opening of less than ⅛, ⅛, ¼, ⅜, ½, ⅝, ¾, ⅞, 1, 1⅛, 1¼, 1⅜, 1½, 1⅝, 1¾, 1⅞, or 2 or more inches. 19. The barrier of any preceding embodiment, wherein said barrier comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more local-failure elements. 20. The barrier of any preceding embodiment, wherein said barrier comprises 1, 2, 3, 4, or more openings of at least 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or more inches in their largest dimension when opened fully. 21. The barrier of any preceding embodiment, wherein the barrier is approximately oval or rectangular and is about 24 by 47 inches. 22. The barrier of any preceding embodiment, wherein the barrier is approximately oval or rectangular and is about 34 by 47 inches.

1a

BACKGROUND OF THE INVENTION [0001] The present invention is broadly directed to improvements in flexible forceps for use in endoscopic surgery and, more particularly, to such improvements which enable a surgeon to more positively position and orient forceps jaws at a surgical site. [0002] Surgery is a learned art requiring many hours of advanced training and skills development that extends far beyond a thorough understanding of the medical principals involved, e.g., anatomy, physiology, principals of wound healing, and the like. The surgeon must also develop hand to eye coordination and acquire skills in the art of tissue manipulation utilizing a variety of highly specialized surgical instruments. The surgical instrument becomes an extension of the surgeon's hand. The surgeon must develop an ability to feel and respond, often delicately yet firmly and positively through his surgical instruments. Accordingly, there exists a need for surgical instruments which are sensitive, responsive, and ergonomically designed to augment the natural motions of the surgeon's hand. [0003] Modern surgery tends toward minimally invasive techniques whenever possible. Although often more complicated in some ways for the surgeon, minimally invasive techniques result in less trauma to the patient and less scarring because of much smaller incisions thereby promoting faster healing and reducing possibilities for infections. In general, minimally invasive surgeries involve making one or more small incisions at appropriate locations and inserting tubular devices through the incisions to the surgical site. The tubular devices may be referred to as endoscopes, arthroscopes, laparoscopes, and the like and often have optical fiber based optical viewing apparatus and light sources, surgical instruments, lumens for inserting instruments or exchanging fluids with the surgical site, or combinations thereof extending therethrough. In some circumstances it is more appropriate to separate the light source and viewing scope from specifically surgical instruments, thus requiring two incisions and endoscopes. This technique is sometimes referred to as triangulation. In other instances, external types of imaging techniques are used for locating endoscopic instruments, such as fluoroscopes, computed tomography, magnetic resonance imaging, or the like. [0004] Endoscopic instruments are configured in a number of different ways depending on their intended purpose. There are rigid endoscopes and flexible endoscopes. Some are simply tubes or portal instruments which provide access to a surgical site for instruments which are passed through the scopes or for the exchange of fluids to and from the surgical site. Viewing scopes, including light sources, may be used for viewing a surgical site for diagnostic purposes or to view surgical operations occurring through the same scope or a different scope. Surgical operations may include cutting, shaving, debriding, cauterizing, or the like as well as grasping tissues or parts of organs, such as with forceps. Some classes of flexible endoscopes have remotely bendable or steerable tips to enable the surgeon to selectively view and/or operate in a selected direction. With such endoscopes, the surgeon operates a control to cause the tip to selectively curl to reorient the tip. U.S. Pat. Nos. 4,901,142, 6,569,087, and 6,773,395 illustrate exemplary details of such steerable tip flexible endoscopic instruments and are incorporated herein by reference. [0005] Remotely controlled forceps are sometimes used in endoscopic surgery for grasping tissues or tissue structures, for surgical manipulation, incision, biopsy, debridement, or the like and may also be used for purposes such as manipulation of other surgical instruments such as suture needles, sutures, or the like. Thus, the use of forceps in endoscopic surgery requires precise and positive positioning to enable the surgeon to accomplish the needed action. [0006] In a typical remotely controlled forceps instrument, forceps jaws are pivotally mounted in a distal yoke and have scissors links connected to ends proximal ends thereof. The scissors links are connected to an operating cable which extends from the distal yoke through a tubular sheath to a proximately located operating slide or lever engaged with a body or shaft, terminating in a thumb or hand grip. The sheath is fixed to the shaft such that the slide and cable are axially movable relative to the shaft and sheath. The scissors links are arranged so that when the slide is pulled toward the grip, the jaws close. This allows the surgeon to securely grasp the forceps assembly for insertion of the forceps jaws toward the surgical site without the jaws opening and impeding insertion or to retract the assembly from the surgical site, possibly gripping tissue or the like therefrom in the jaws. When the jaws are closed, they are retracted within the yoke which has a diameter not significantly greater than the outer diameter of the sheath. When the slide is pushed relative to the shaft, the jaws are opened. Additional details of remotely controlled endoscopic forceps can be found in U.S. Pat. Nos. 4,763,668 and 5,810,876 which are incorporated herein by reference. [0007] In use of remotely controlled forceps, the surgeon needs to be able to accurately orient the forceps jaws. When remotely controlled forceps are inserted and operated through a rigid endoscopic instrument such as a rigid trephine or trocar, the relationship between the forceps cable and sheath and between the sheath and the lumen of the trephine or trocar is relatively fixed. Therefore, there is usually no binding between the sheath of the forceps instrument and the lumen of the rigid endoscope. However, with flexible endoscopes with remotely bendable tips, there can be frictional interaction of the forceps sheath and the lumen of the scope. The result with conventional forceps is that the surgeon rotates the forceps to orient the jaws at a desired angle, but binding occurs between the sheath and endoscope lumen until a certain resilient force in the forceps sheath overcomes the friction, causing the forceps jaws to rotate suddenly and overshoot the desired angle. Thus, it is often difficult for the surgeon to positively position the jaws of the forceps without frustrating and time consuming trial and error. SUMMARY OF THE INVENTION [0008] The present invention provides improvements in endoscopic forceps instruments which enable a surgeon to more accurately and positively orient the jaws of such instruments, particularly with respect to use with flexible endoscopes. [0009] The present invention overcomes the problem of binding of the forceps sheath in a curved flexible endoscope by limiting the torsional resilience of the combination of the forceps sheath and operating cable in a rigidity region of the forceps. The rigidity region of the forceps is defined by a junction between a cable assembly associated with the forceps and a lumen associated with the flexible endoscope and is provided for increasing the deflectional resistance of the forceps. In typical remotely operated endoscopic forceps instruments, the sheath is formed by a steel wire helically wound or wrapped around a spring steel operating cable and gripped at the proximal and distal ends by the proximal body shaft and the distal yoke structure. The arrangement is similar to the configuration of a bicycle hand brake cable arrangement, sometimes referred to as a Bowden cable arrangement. The wrapped steel sheath enables the operating cable to be extended and retracted with low frictional resistance, even when the assembly is curved relatively tightly. The arrangement also provides sufficient axial stiffness to enable the distal end with forceps jaws mounted within a yoke to be inserted through the lumen of a flexible endoscope. [0010] In an embodiment of the improved endoscopic forceps, in order to limit the torsional resilience of the forceps cable assembly of an operating cable and sheath, and thus increase the torsional rigidity thereof, the length of the cable assembly is limited in length. In one embodiment having a cable assembly an outer diameter of approximately 1.5 mm, the length of the cable assembly is no more than about 14 inches (35.5 cm). The action of orienting the forceps jaws is further improved by the material forming the lumen of the flexible endoscope is one which has a low relative frictional coefficient with respect to the steel or stainless steel of which the sheath is formed. Finally, the inner diameter of the endoscope lumen is sized with a relative tolerance to the outer diameter of the forceps tip mechanism and cable assembly to enable free movement through the lumen. By these means, binding of the forceps cable assembly within the endoscope lumen when the endoscope tip is curved is minimized to thereby enable more positive and accurate orientation of the forceps jaws. In one embodiment the elongated cable assembly may be separated from the proximal handle section for distal receipt by the endoscopic instrument and reconnected to the proximal handle section at the port. [0011] Various objects and advantages of the present invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. [0012] The drawings constitute a part of this specification, include exemplary embodiments of the present invention, and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is a side elevational view of an embodiment of an endoscopic flexible forceps apparatus with improved torsional rigidity according to the present invention. [0014] FIG. 2 is a greatly enlarged side elevational view of a distal tip of the forceps apparatus and illustrates forceps jaws in a closed relationship. [0015] FIG. 3 is a greatly enlarged side elevational view of the distal tip of the forceps apparatus and illustrates the forceps jaws in an opened relationship. [0016] FIG. 4 is a perspective view of a flexible endoscope instrument with a remotely bendable tip. DETAILED DESCRIPTION OF THE INVENTION [0017] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. [0018] Referring to the drawings in more detail, the reference numeral 1 generally designates an embodiment of a flexible forceps apparatus with improved torsional rigidity according to the present invention. The apparatus 1 is inserted through a flexible endoscope instrument 3 ( FIG. 4 ) for grasping structures within an endoscopic, arthroscopic, laparoscopic, or similar type of surgical site. The forceps apparatus 1 generally includes a proximal handle section 8 , an elongated cable assembly 10 , and a distal tip section 12 including a pair of opposed forceps jaw members 14 . [0019] Referring to FIG. 1 , the illustrated handle section 8 includes an elongated rod shaped handle frame 18 terminating proximately in a thumb ring 20 . An operating spool 22 is slidably mounted on the frame 18 and has an attachment post assembly 24 including a set screw extending through an elongated slot 26 formed through a section of the frame 18 . A proximal end of a jaws operating cable 30 is attached to the post 24 by means of the set screw. A proximal end of a tubular cable sheath 32 of the cable assembly 10 is secured to a distal end of the handle frame 18 . Although not illustrated, the sheath 32 can be formed by a wire of round or flattened cross section which helically wound or wrapped about the cable 30 . [0020] In one embodiment, the spool 22 may include a concave parabolic surface for operative gripping. In another embodiment, the cable assembly 10 is removably attached to the proximal handle section 8 for distal receipt by the endoscopic instrument 3 and reconnection to the proximal handle section 8 at an instrument port 56 associated with the endoscopic instrument 3 . [0021] Referring to FIGS. 2 and 3 , the tip section 12 includes a pair of forceps jaws mounting yoke 36 which is secured to a distal end of the cable sheath 32 . The yoke 36 has the forceps jaw members 14 pivotally connected between legs thereof. Each jaw member 14 is formed by a proximal jaw lever 38 and a distal jaw 40 . Although not illustrated, the jaws 40 can be provided with serrated or toothed gripping surfaces. Each jaw lever 38 is pivotally connected to a respective scissors link 42 , and ends of the links 42 are pivotally connected together and secured to a distal end of the operating cable 30 . Retraction of the cable 30 into the sheath 32 pulls the scissors links 42 in a proximal direction and thereby pivots the jaws 40 toward closed positions. Conversely, extension of the cable 30 in a direction out of the sheath 32 pushes the scissors links 42 in a distal direction and pivots the jaws 40 toward open positions. [0022] In operation of the forceps apparatus 1 , the surgeon holds the handle section 8 with a thumb extended through the thumb ring 20 and with the operating spool 22 held between the forefinger and middle finger or, alternatively, between the middle finger and ring finger. Movement of the spool 22 toward the thumb ring 20 pulls the cable 30 in a retraction direction, thereby closing the forceps jaws 40 . Conversely, movement of the spool 22 away from the thumb ring 20 extends the cable 30 , thereby opening the forceps jaws 40 . [0023] Referring to FIG. 4 , the illustrated flexible endoscope apparatus 3 includes a handle section 48 to which is attached an elongated composite scope assembly 50 which is inserted through an incision or through a patient's body orifice by a surgeon. The scope assembly 50 typically includes (not shown) one or two fiberoptic bundles carrying light from a remote light source, a coherent fiberoptic bundle carrying an image viewed within the surgical site, one or more fluid carrying lumens, and an instrument lumen for the insertion of endoscopic surgical instruments, such as the forceps apparatus 1 . The image carried by the coherent fiberoptic bundle illuminates an image array within the handle section 48 , and a video signal is communicated to a remote video monitor by a video cable 52 for direct viewing by the surgeon and possible recording. The handle section 48 is provided with one or more fluid controls 54 , for controlling the injection of fluids into the surgical site or suction, and the instrument or forceps port 56 , through which a surgical instrument such as the forceps apparatus 1 can be inserted. The illustrated scope assembly 50 has a bendable or steerable tip 58 which is selectively controlled by the surgeon by rotation of a steering control 60 mounted on the handle section 48 . [0024] When use of the forceps apparatus 1 with the endoscope instrument 3 is needed, the surgeon grasps the handle section 8 and pulls the spool 22 toward the thumb ring 20 to close the jaws 40 and to increase the axial rigidity of the cable assembly 10 . The tip section 12 is inserted into the forceps port 56 of the instrument 3 , followed by the cable assembly 10 . Insertion is continued until the tip section 12 reaches the surgical site. The tip section 12 and cable assembly 10 must pass through any curves in the composite scope 50 . Once the tip section 12 is at the surgical site, the surgeon must carefully position and orient the jaws 40 for use in grasping whatever structure requires manipulation. Correction of the axial position of the tip section 12 is a simple matter of extending or retracting the apparatus 1 with respect to the endoscope instrument 3 . However, angular correction of the orientation of the jaws 40 is sometimes resisted by frictional contact of the cable sheath 32 with inner walls of the lumen (not shown) through which the cable assembly 10 extends, particularly at locations of bends in the composite scope 50 . Torsional resistance to rotation of the cable assembly 10 is resisted until overcome, at which point, the tip assembly 12 suddenly jumps. Thus, angular correction of the jaws 40 sometimes overshoots the desired orientation. [0025] In order to overcome orientation problems with the forceps jaws 40 , improvements are made in the cable assembly 10 to increase its rotational rigidity without affecting the overall flexibility of the cable assembly 10 . The length of the cable assembly 10 from a distal end of the handle frame 18 to the tip assembly 12 is limited to control the torsional resilience of the cable assembly 10 . In the illustrated apparatus 1 , the length is limited to about 14 inches (35.5 cm). The illustrated cable sheath 32 is formed by a stainless steel wire wrapped helically about the operating cable 30 . The desirable length of the cable assembly 10 may be different for other materials and types of construction of the cable sheath 32 . Additionally, the outer diameter of the cable sheath 32 must have a desired clearance within the instrument/forceps lumen within the composite scope 50 . Finally, the relative coefficient of friction between the material forming the cable sheath 32 and the forceps lumen must be low to further reduce frictional binding between the cable sheath 32 and the forceps lumen. [0026] To improve the torsional rigidity region 16 associated with the apparatus 1 , it is desirable to decrease the accumulation of stress leading to the torsional deformation of the cable assembly 10 and decrease the frictional resistance generated between the cable assembly 10 and the flexible endoscope 3 , improving the transmission of the flexible forceps 1 to the surgical site. Stated differently, the torsional rigidity region 16 can be improved by increasing the torsional rigidity and decreasing the flexural rigidity. In one embodiment the improved torsional rigidity region 16 , defined by a junction between the cable assembly 10 including the sheath 32 and cable 30 and a lumen 50 a associated with the elongated composite scope assembly 50 , may be provided, the sheath 32 having an outer sidewall with a reduced frictional surface for being received by the lumen 50 a wherein the lumen 50 a and the sheath 32 have complementary properties for increasing the deflectional resistance of the distal tip section 12 while preventing the cable assembly 10 from binding within the composite scope assembly 50 . [0027] Generally, the distal end of the composite scope assembly 50 is separated a distance from the distal tip section 12 , which itself is further separated from the surgical site. Depending upon the characteristics and configuration of the received flexible forceps 1 , the separation distance is between X and Y millimeters, where a distance less than X or greater than Y would provide non-optimal insertional rigidity for the flexible forceps 1 . The change between X and Y is represented by Δx and the moment of inertia corresponding to the composite scope assembly outer surface 50 corresponds to mr 2 where m is the mass of the composite scope assembly 50 and r is the corresponding radius. The moment of inertia related to the flexible forceps 1 therefore corresponds to (mL 2 )/3 where L is the length, Δx, and m is the mass of the flexible forceps 1 . In this case, the flexible forceps 1 has an exponentially greater moment of inertia based upon Δx, however, as Δx increases the moment decreases resulting in a corresponding loss of rigidity of the flexible forceps 1 . Stated another way, as the distal tip section 12 extends farther out of the distal end of the composite scope assembly 50 , the flexible forceps 1 become less torsionally rigid. In addition, by decreasing Δx, cartilage or other tissue associated with the surgical site may be damaged by a corresponding increased rigidity associated with the flexible forceps 1 extending past the composite scope assembly distal end 50 . [0028] It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Present Disclosure [0002] This disclosure relates generally to the field of dental devices and, more particularly, to a mouthpiece having a relatively rigid thermoplastic substrate portion and a soft, low-friction overlay portion. [0003] 2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 [0004] Brown, U.S. D354,346 discloses a design for an oral condom. [0005] Johnson, U.S. D388,514 discloses a design for a protective mask. [0006] Atz, U.S. D529,615 discloses a design for a novelty mouthpiece. [0007] Jacobs, U.S. Pat. No. 3,312,218 discloses a protective mouthpiece which may be molded at a temperature higher than body temperature to conform to the wearer's teeth and gums, and which, after cooling, will be tough, resilient and shape-retaining at body temperatures. [0008] Jacobs, U.S. Pat. No. 4,044,762 discloses an athletic mouth guard for use by participants in contact sports to simultaneously protect and topically treat the teeth. The mouth guard is a generally U-shaped channel molded preferably from a composition of thermoplastic resin and a fluoride compound such as sodium fluoride, stannous fluoride, or sodium fluorosilicate. The fluoride compound is released from the molded resin mouth guard to the wearer's teeth over extended periods of use. [0009] Harding, U.S. Pat. No. 4,949,731 discloses an elastic and flexible oral prophylactic that conforms to the mouth. The hygienic appliance may incorporate texture and flavor, and includes impermeable and permeable embodiments. [0010] Esqueda, U.S. Pat. No. 4,974,605 discloses a soft and pliable mask for the lower face for the prevention of disease, comprised of a molded mask and straps or bands to hold it in place. Breathing passages are provided. A cavity at the bottom fits around the chin and the top edge may be thicker, or reinforced, to provide close adhesion around the nose. [0011] Johnson, U.S. Pat. No. 5,016,649 discloses an invention that relates to a protective mask, and more particularly to a protective mask usable during the act of oral sex or during the performance of mouth-to-mouth resuscitation to protect a wearer against infection with communicable diseases including viral diseases such as the human immune virus which leads to the development of acquired immune deficiency syndrome (AIDS). The mask is formed by an elongate, generally planar membrane of a tough film material having, when lying flat, a longitudinal axis and an outline configuration which is asymmetrical about that axis, the outline configuration having a lateral extension portion for extending downwardly and rearwardly over the chin of a wearer. The mask is securely wrapped in place over the lower face of a wearer while permitting free movement of the jaw, lips and tongue of the wearer and includes a flaccid pouch-like central portion. [0012] Burr et al., U.S. Pat. No. 5,318,043 discloses a condom designed for oral-genital sex includes, in one aspect, a device adapted to be worn in the mouth of the person practicing oral sex. The device includes a tubular member having one closed end and formed of thin, pliant, impervious material. Joined to the open end of the tubular member are two or three flanges extending generally radially outwardly and spaced closely together. The flanges are curved out of a plane transverse to the axis of the tubular member to define a channel adapted to receive the upper and lower lips of an average person. The device is gripped by placing the lips within the channel, and closing the jaws slightly to compress and retain the open end of the device. The tubular member may be formed to extend into the mouth of the wearer, for the purpose of performing fellatio. A penis may be inserted into the tubular member without making contact with the lips or mouth or tongue of the wearer. In an alternative form of the invention, the tubular member may extend outwardly from the flanges and the mouth, so that the tongue of the wearer may be extended into the tubular member to perform cunnilingus without making direct contact with the vulva. In another aspect of the invention, there is provided a shield formed as a planar oval from pliant, impervious material, the shield being shaped and adapted to be placed over the genital area. The shield includes a central opening from which a tubular condom extends, so that the assembly may be employed for oral sexual contact as well as intercourse without the risk of skin-to-skin contact. In a modification of this embodiment, the shield is provided as a separate component, with a flange surrounding the central opening. The flange is provided with means for engaging and sealing with the outer circumferential edge portion of a typical prior art male condom, so that the shield may be joined temporarily to a commercially available condom for the practice of safe sex. [0013] Williams, U.S. Pat. No. 5,388,592 discloses a disposable protective barrier formed of an elongated planar membrane comprising a strong virus impermeable film prevents the exchange of body fluids during oral sex. In one embodiment, the invention provides a protective mask that shields the facial area of the wearer, including the mouth, side face, the front of the nose, and the front and under chin, from undesirable exposure to infection carrying microorganisms, while permitting unrestricted freedom of movement of the wearer's jaw, lips, nose, and tongue. Another embodiment of the invention provides a brief that uses any of various securing means that may include variable strap size and contoured thigh placement. Materials that exhibit plastic cohesive attraction to human skin are employed to secure the mask or brief to the wearer, thereby ensuring that the garment stays in the desired position for greater protection when in use. [0014] Daley, U.S. Pat. No. 5,390,681 discloses a prophylactic device for oral sex comprising a body portion with a reservoir extending from one side and peripheral portion extending from an opposite side thereof. [0015] Bloodsaw, U.S. Pat. No. 5,409,016 discloses an oral condom which protects the user from contracting sexually transmitted diseases while engaging in oral, vaginal or anal sex. The oral condom provides an improved protective mask which is capable of protecting the facial area of a user from undesirable exposure to infection carrying microorganisms. The oral condom is shaped like an oval with two lateral leg portions which are attached to two ear attachments respectively. The oral condom includes conformed portions for the lips so that the lips can be more easily moved in a natural way and an extended portion for the tongue so the tongue can move in a natural way and not be hindered by the oral condom. [0016] Hopkins et al., U.S. Pat. No. 5,449,486 discloses a method of manufacturing a facial prophylactic from a fluid impervious stretchable material comprises working the material while in a liquid state to regions of different thicknesses and elasticities to form a mask having a thinner tongue receiving portion generally centrally of the mask and a thicker main portion peripherally of the tongue receiving portion. The overall mask has a one piece construction and is free of any seams penetrating through the mask. [0017] Fenton, U.S. Pat. No. 5,499,633 discloses an adjustable oral device for placement within the mouth of a user to reduce or eliminate snoring. The device comprises an upper member having a substantially curved shape and defining an upwardly oriented channel for receiving at least some of the upper teeth of a user; a lower member having a substantially curved shape and defining a downwardly oriented channel for receiving at least some of the lower teeth of a user; wherein the upper member is adjustably coupled by the user to the lower member in a spaced relationship such that the lower member is positioned relative to the upper member so that when the user's teeth are retained within the device, the user's lower jaw is biased substantially forward of its normal biting or resting position to reduce snoring. The device can include an anterior tongue space between the upper and lower members, and can further include moldable material positioned within at least one of the channels for substantially conforming to a shape of the teeth, thus allowing the device to be customized for individual users. [0018] Hussey, U.S. Pat. No. 5,582,187 discloses a thin, flexible shield for the mouth to protect against transmission of STDs (Sexually Transmitted Diseases) during cunnilingus and oral-anal sex. A shield is held over the mouth either alone or in a holder assembly by mounting devices which retain the mask against the face of the user. The holder assembly may consist of one or two rings interlocked with each other or with the shield to grip the shield. [0019] Johnson, U.S. Pat. No. 5,785,052 discloses a versatile disposable film protective mask includes an outlined boundary, a top pair of primary film strings, two top pairs of secondary film strings/ear loops, a bottom pair of primary film strings, a well-defined chin guard having chin guard receptors, jaw webs, cheek webs, an oral cavity web having oral cavity receptors and a reversible half-oval shaped flaccid oral cavity pouch. In a preferred embodiment, the versatile disposable film protective mask further includes a thin lining for those who are allergic to the film and to absorb liquids, i.e. saliva and/or perspiration produced by the wearer of the mask. The versatile disposable film protective mask can also be employed as a resuscitation mask, a dental dam, a male G-string flaccid pouch with a disposable film flaccid pouch harness or a female G-string flaccid pouch with a disposable film flaccid pouch harness. The versatile disposable film protective mask is employable for protecting the wearer against oral and genital infections with communicable diseases including viral diseases such as Human Immunodeficiency Virus (HIV) which has been known to lead to the development of Acquired Immunodeficiency Syndrome (AIDS). The mask is also employable for protecting the wearer against other oral and genital infections and Sexually Transmitted Diseases (STD's). [0020] Ochel, U.S. Pat. No. 5,970,981 discloses a mouthguard including a U-shaped upper bite plate which removably fits over upper teeth of a person, the upper bite plate including an upper lingual side, an upper buccal side and a lower side which connects together the upper lingual and buccal sides in a U-shaped cross-sectional configuration, the lower side having a lower exposed surface, and the entire upper bite plate being made from a soft, deformable and edible gummi candy; and a U-shaped lower bite plate which removably fits over lower teeth of the person, the lower bite plate including a lower lingual side, a lower buccal side and an upper side which connects together the lower lingual and buccal sides in a U-shaped cross-sectional, the upper side having an upper exposed surface, and the entire lower bite plate being made from a soft, deformable and edible gummi candy. [0021] Tyler, U.S. Pat. No. 6,244,269 discloses a two piece pliable, edible, flavored mouthpiece to be worn by one consenting adult performing oral sexual activities such as cunnilingus and fellatio, and the like, on another consenting adult. The mouthpiece can be formed from pliable flavored edible materials such as but not limited to starch jellied candies, gelatin candy (i.e. Gummy Bears™), starch gelatin, licorice, chewing gum, and the like. The mouth piece includes a top U-shaped single piece set for fitting about the front top and partial top side teeth of the wearer, and a bottom U-shaped single piece set for fitting about the front bottom and partial bottom side teeth of the wearer. The wearer clenching down customizes the fit of the mouthpiece therein and changes the sharp hard edges of the teeth to be soft and rounded. Each piece uses more material adjacent to between the front teeth, tapering to less material toward the back of the side teeth. Optionally, at least one of the top and bottom teeth members can have a half circular through hole, through a center portion of the front teeth section to allow a portion of another person's body part such as a tip portion of a person's tongue, nipple, toes, fingers, clitoris, penis, and/or body fluids to pass therethrough. [0022] Hostettler et al, U.S. Pat. No. 6,265,016 discloses a process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water. [0023] Schwartz, U.S. Pat. No. 6,499,995 discloses a glow-in-the-dark plastic dental appliance typically for pediatric dental patients, and method of constructing the appliance. According to a preferred method of the invention, the dental appliance is constructed by first forming an impression of a patient's upper or lower dentition and constructing a cast from the impression. The appliance is thermoformed over the cast, typically using a vacuum or pressure thermoforming machine and a sheet, plate or disc of thermoformable plastic impregnated or coated with a phosphorescent material. The appliance is capable of glowing in the dark for a limited period of time after exposure to a light source and as the appliance is worn on the patient's dentition, and is capable of repeated phosphorescence throughout the dental treatment period. [0024] Zacco, U.S. Pat. No. 7,143,767 discloses a mouthpiece and method for reducing snoring comprising a mouthpiece body of a thermoplastic material having a shape generally complementary to the person's dental arch, including a posterior end having two spaced apart members positioned toward the back of the person's dental arch when properly worn, and an anterior end having an airway opening therethrough, the anterior end positioned when properly worn to support the person's lips spaced apart so that air flows through the airway opening; and a substantially rigid protective mold of a thermostable material, the protective mold protecting at least a periphery of the mouthpiece body. [0025] The related art described above discloses various types of mouthpieces for a variety of purposes. However, the prior art fails to disclose a mouthpiece that has a soft, low-friction overlay. The present disclosure distinguishes over the prior art providing heretofore unknown advantages as described in the following summary. BRIEF SUMMARY OF THE INVENTION [0026] This disclosure teaches certain benefits in construction and use which give rise to the objectives described below. [0027] In human sexual behavior fellatio is a common practice. However, this practice can be uncomfortable when the giver is inexperienced, when there is not enough lubrication, and when sharp tooth edges are inadvertently involved. The presently described apparatus is a solution to this difficulty. A mouthpiece of the type used by athletes in contact sports is used as a substrate and may be molded to the dental formation of a user's mouth, as is well known in the art, and as is described in several of the references sited herein. An overlay of a soft and relatively slippery material is placed onto the substrate and forms the primary contact surface with the male organ. [0028] A primary objective inherent in the above described apparatus and method of use is to provide advantages not taught by the prior art. [0029] Another objective is to provide a mouthpiece that reduces friction during fellatio. [0030] A further objective is to provide such a mouthpiece that provides a soft and yielding surface to any object in contact therewith including sore gums. [0031] Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the presently described apparatus and method of its use. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0032] Illustrated in the accompanying drawings is at least one of the best mode embodiments of the present invention In such drawings: [0033] FIG. 1 is a perspective view of the presently described apparatus; and [0034] FIG. 2 is a rear elevational view thereof. DETAILED DESCRIPTION OF THE INVENTION [0035] The above described drawing figures illustrate the described apparatus and its method of use in at least one of its preferred, best mode embodiment, which is further defined in detail in the following description. Those having ordinary skill in the art may be able to make alterations and modifications to what is described herein without departing from its spirit and scope. Therefore, it must be understood that what is illustrated is set forth only for the purposes of example and that it should not be taken as a limitation in the scope of the present apparatus and method of use. [0036] Described now in detail is a mouthpiece apparatus with a relatively rigid substrate portion and an overlay portion of a soft, low-friction material. FIGS. 1 and 2 illustrate the various aspects of the inventive mouthpiece herein described. Therefore, now referring to these figures, the present invention comprises a substrate portion 10 and an overlay portion 20 where the overlay portion 20 is attached to the substrate portion 10 by thermal bonding, polymer welding, adhesive bonding or any other prior art technique that results in an intimate and monolithic formation of the two portions so that they are inseparable. [0037] The substrate portion 10 of the present invention is U-shaped as shown in FIG. 1 and also has a U-shaped cross section as shown in FIG. 2 . The prior art teaches this substrate portion in great detail including the shape and material that such a substrate portion may be comprised of. Please refer to Jacobs, U.S. Pat. No. 3,312,218 which is hereby incorporated by reference into this disclosure. [0038] The overlay portion 20 is a polymer with the characteristics of: high adhesion to the substrate during the assembly process, and a soft and compliant texture with a low-friction or slippery surface. This overlay portion 20 is preferably produced by making at least a portion of an outer surface of the substrate chemically reactive by affixing reactive chemical functional groups to it. Next, the treated substrate is coated with a first coating 22 comprising a hydrophilic prepolymer intermediate, which is capable of forming a polyurethane-polyurea hydrogel-forming polymer, and which contains terminal isocyanate groups, such that at least a portion of said terminal isocyanate groups are covalently bonded to the surface of said substrate, forming covalent polyurea bonds and thereby resulting in the formation of a tie coat of a polyurethane-polyurea hydrogel-forming polymer, that adheres to the surface of the substrate, and wherein at least a portion of the terminal isocyanate groups of said polyurethane-urea prepolymer intermediate are present in the polyurethane-polyurea hydrogel-forming polymer, such that they remain free to react with other species. Finally, the overlay portion 20 is coated with a second coating 24 comprising a moisture-containing hydrogel-forming compound, further containing isocyanate-reactive chemical functional groups, such that a barrier coat of a hydrogel is formed upon the application of the second coating to the tie coat of the first coating. If the second coating is foamed, i.e., aerated, the resultant is a slippery surface that is soft and compliant. The overlay process is taken in part from Hostettler et al, U.S. Pat. No. 6,265,016 which is hereby incorporated herein by reference. [0039] As shown in the figures, the assembly of the mouthpiece results in the overlay portion 20 being placed on the convex surfaces of the substrate portion 10 . In use, the substrate portion 10 may be heated to a point of softening such that an interior surface 12 may be impressed by the teeth of a person that will wear the apparatus. This process of customizing a mouthpiece for a particular person is very well known in the art. [0040] In use, the upper and-or the lower teeth of a user are covered by one of the described apparatus. The apparatus, as worn, is able to cushion the gums of the user against painful contact from the opposing dental formations when speaking and chewing. The apparatus is also able to provide safe and pleasurable oral sex activity. [0041] The enablements described in detail above are considered novel over the prior art of record and are considered critical to the operation of at least one aspect of the apparatus and its method of use and to the achievement of the above described objectives. The words used in this specification to describe the instant embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification: structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use must be understood as being generic to all possible meanings supported by the specification and by the word or words describing the element. [0042] The definitions of the words or drawing elements described herein are meant to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements described and its various embodiments or that a single element may be substituted for two or more elements in a claim. [0043] Changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalents within the scope intended and its various embodiments. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. This disclosure is thus meant to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted, and also what incorporates the essential ideas. [0044] The scope of this description is to be interpreted only in conjunction with the appended claims and it is made clear, here, that each named inventor believes that the claimed subject matter is what is intended to be patented.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to room fragrance devices. Particularly, the present invention relates to passive room fragrance devices. 2. Description of the Prior Art Fragrance devices are often used in the home and include fresh fragrant flowers and fruits. When fresh fragrant flowers and fruits are not in season, or not desired due to cost, pollen allergies, or other considerations, natural and manmade fragrance devices have been utilized. These fragrance devices include potpourri, candles, incense, perfumes, toilet waters, fragrant aerosol sprays and gel-type air fresheners. Potpourri often contains a mixture of wood chips and dried flowers, fruits, leaves, nuts and the like that have either a natural fragrance or a fragrance imparted onto the mixture. In the home, the use of containers to hold colored and scented potpourri is well known. Potpourri, however, spills easily, gets dusty, degrades and generally becomes messy. Candles, when burned, produce an aesthetic ambiance and a pleasant fragrance. Nevertheless, burning candles are unsuitable for use in homes with small children or pets where a lit candle can be accidentally knocked over causing burn injuries or resulting in a house fire. In addition, burning candles produce hot wax that can damage furniture or create injury. Likewise, incense must be burned in order to produce a scent. Burning incense, like a burning candle, can also be accidentally knocked over resulting in an increased risk of burn injuries or a house fire. Burning incense also produces messy ashes. Aerosol perfumes, aerosol toilet waters and fragrant aerosol sprays of varying pleasant aromas are also well known to dispense a scent into a room. Aerosol particles dissipate into the air quickly, however, resulting in a need to spray the perfume, toilet water or other fragrant aerosol again and again at relatively short time intervals to maintain the desired level of fragrant scent. Gel-type air fresheners are yet another type of air freshener. These are available in a passive configuration that sits on a shelf and in an active configuration that plug into an electrical outlet. This type of air freshener gives off a scent over a greater period of time. Even though improvements in the appearance of gel air fresheners have occurred, such air fresheners often have an industrial, unsightly appearance that detracts from a home's decor. U.S. Pat. No. 4,747,539 (1988, Spector) discloses a reversible on-off fragrance emitting unit that is adapted to rest on a flat surface in either an upright or an upside down position. In one position, no fragrance is emitted. In the other position, a fragrance is emitted. The unit consists of a vented cylindrical shell closed at its upper end by a cover plate and at its lower end by a bottom wall. Disposed within the shell and secured to the cover plate is an absorbent pad. Joined to the pad is the leading end of a series of interhinged absorbent elements in an accordion formation. The trailing end of the series is joined to a weight whereby when the unit is upside down, the accordion is collapsed on the bottom wall and compressed by the overlying weight. When the unit is reversed in position and is made upright, the weight drops to the bottom wall, thereby expanding the accordion. The pad and the elements of the accordion are impregnated with a volatile fragrance, the pad acting as a reservoir therefor, whereby in the upside down position of the unit when the accordion is collapsed, no fragrance is emitted, and when in the upright position in which the accordion is expanded to expose the elements thereof, fragrance is emitted. U.S. Pat. No. 4,913,349 (1990, Locko) discloses a device for dispensing volatile fragrances. The device comprises a hollow body and a liquid volatile fragrance contained within the hollow. The liquid volatile fragrance diffuses through a closure member made of a silicone rubber body to the outer surface where it is volatilized to disperse in the surrounding atmosphere. U.S. Pat. No. 5,163,616 (1992, Bernarducci et al.) discloses an air freshener device with visual signal means. The air freshener device indicates when air freshening fragrance formulation contained therein is consumed. The device has a plurality of chambers which contain the same or different fragrance formulations. The inner walls of the chambers are contrastingly colored with respect to the fragrance formulation so that, when the fragrance formulation is consumed, the colored walls are exposed indicating to the user that the formulation within that chamber has been depleted. The multi-chamber feature of the device provides the possibility of multiple fragrance choices and, at the same time, allows for the release of fragrance for an extended period of time. Sheet, or towelette, dispensers are commonly known in the field of personal hygiene. Personal hygiene sheet dispensers often contain combined dispensing and closure assemblies with sheet dispensing apertures designed and sized to prevent the protruding liquid-soaked sheet from drying out or from acting as a wicking component causing evaporation of the wet cleansing solution. U.S. Pat. No. 6,138,867 (2000, Stelmack) discloses a towelette dispenser where the dispenser includes a closure having a well sized and shaped to receive and store a portion of a towelette extending out of the opening. The dispenser also includes a selectively movable cover having an opening defined therein that, when brought into alignment with the well, permits access to a towelette. When not in alignment, the movable cover establishes a substantially air-tight seal. U.S. Pat. No. 5,718,353 (1998, Kanfer et al) discloses a towelette dispensing closure assembly for attachment to the lid of a container for the storage and dispensing of towelettes so as to be receivable within a preformed keyhole-shaped opening in the container lid. The assembly includes a body with a main radially extending flange larger than the opening in the lid. The lower portion of the body carries radially extending locking tabs which are dimensioned to fit through the lid opening and, upon the closure being turned, to engage the lower surface of the lid in opposed relationship with the flange which engages the upper surface. Antirotation tabs also extend radially of the lower portion of the body and again, upon rotation engages the edges of the lid opening to thus secure the closure on the lid. A cap is also provided to releasably engage the upper portion of the closure body to provide a substantially airtight seal for the container. U.S. Pat. No. 5,560,514 (1996, Frazier) discloses a wet wipe dispensing nozzle with rotatable port. The centerflow dispenser includes a dispensing nozzle affixed to the container of wet wipes. The nozzle has a rotatable dispensing disk with dispensing orifice therethrough which includes a node and a plurality of contiguous appendages such that the disk will rotate to the path of least resistance as the saturated wipers are drawn through the dispensing orifice regardless of the direction of extraction through the orifice. One or more drain holes are provided through the dispensing disk to allow liquid squeezed from the wiper as it is drawn through the dispensing orifice to pass back into the container. The nozzle includes a funneled section which collects any liquid squeezed or which may drip from the wipe as it is extracted from the container and directs that liquid toward the drain holes in the dispensing disk. A cap is provided which sealingly engages the nozzle to limit vapor emissions from the container when the cap is in the closed position. International Publication No. WO 01/74687 A1 (2001, Buck et al.) discloses a wet wipe container with flexible orifice so that a user may reach through the slits to grasp a wet wipe in the event that the pop up feature fails. Further, the nature of the flexible, rubber-like material or sheet having the slits must, among other things, be sufficiently stiff to maintain a reasonable impediment against evaporation losses and to hold the wet wipes in the pop-up position. It should be understood that the cleansing liquids used in wet wipes generally consist of water and alcohol in order to enhance evaporation of the liquid in a relatively short time period after a wet wipe is used. This formulation is the reason the prior art is concerned with the use of airtight seals to prevent evaporation of the liquid in the wet wipe container. Therefore, what is needed is a fragrance dispenser system that allows dispensing of a room fragrance at a variable rate. What is also needed is a fragrance dispenser system that is a passive fragrance dispenser that uses a plurality of separable sheets. What is further needed is a fragrance dispenser system that can be used as a drawer or closet fragrance applicator. What is still further needed is a fragrance dispenser that can be used as a personal fragrance applicator. What is yet further needed is an aesthetically pleasing fragrance dispenser system that complements the decor of a room. SUMMARY OF THE INVENTION It is an object of the present invention to provide a passive room fragrance dispenser system that is easily renewed at a given time interval without replacing the core fragrance-producing component. It is another object of the present invention to provide a fragrance dispenser system that can dispense a fragrance at a variable rate. It is also an object of the present invention to provide a room fragrance dispenser system that does not require an open flame. It is still another object of the present invention to be outwardly decorable to reduce the industrial appearance of the device. It is a further object of the present invention to be readily insertable into an aesthetically pleasing home decor container to further reduce the industrial appearance of the device. It is yet another object of the present invention to provide a fragrance dispensing system that can be secondarily used as a personal fragrance applicator. It is yet another object of the present invention to provide a fragrance dispensing system that can be secondarily used as a drawer or closet fragrance applicator. It is still yet another object of the present invention to provide a fragrance dispensing system that can be secondarily used as a garbage receptacle fragrance applicator. The present invention achieves these and other objectives by providing a disposable sheet fragrance delivery system having an enclosure, a plurality of dispensable sheets, a quantity of fragrance solution, and a sheet dispensing outlet. A sheet dispensing outlet cover may optionally be provided. The enclosure has a main body, a bottom and a top. The enclosure can be of any size or shape, but is typically less than twelve inches in height and twelve inches in diameter. The container exterior may be made of any waterproof natural or manmade material such as glass, ceramic, plastic, metal, composites, and the like. The top or bottom of the container may be made of a different material than the body of the container. The top or the outside surface of the container may contain decoratively-shaped openings to increase the dissipation of the fragrance solution into the air. The container may be aesthetically decorated to stand alone in a room. External finishes, such as frosted, painted, jeweled or labeled finishes may be applied to the stand-alone container. The fragrance container may also be adaptably shaped for further insertion into a corresponding home decor container of varying size, shape, or color. The top of the enclosure houses the sheet dispensing outlet. The size of the sheet dispensing outlet is one of several factors that is critical to the present invention's ability to dispense a room fragrance. Unlike the sheet dispensing openings of a cleaning towelette dispenser that are designed to limit the evaporation of the highly volatile cleaning solution and the wicking action of the towelette, the sheet dispensing outlet of the present invention is sized to allow and to enhance the dissipation of the fragrance solution from the container preferably through the wicking action of the dispensable sheet. The shape of the opening is not critical, only its size. The plurality of dispensable sheets has a structure that permits capillary action. Sheets of the present invention are preferably made of an airlaid, nonwoven substrate. A nonwoven substrate is a fabric consisting of an assembly of textile fibers such as wood pulp, rayon, polyester fibers, and the like, that are oriented in one direction or in a random manner. They are typically held together by mechanical interlocking, by fusing of thermoplastic fibers, or by bonding with a rubber, starch, glue, casein, latex, or a cellulose derivative or synthetic resin. Airlaying is a technique of dispersing fibers in a moving airstream and then collecting them on a forming surface to produce lofty, porous webs. Airlaid fabrics are very absorbent, yet lightweight. The plurality of sheets may be rolled and perforated or otherwise separably stacked to allow for insertion of a portion of a single sheet through the sheet dispensing outlet. The sheets are typically less than twelve inches by twelve inches. The sheets may be dyed with a color to correspond with the scent of the fragrance solution. The sheet roll or stack may either be saturated with fragrance solution before placement into the container or the fragrance solution may be dispensed onto the sheet roll or stack after placement into the container until the saturation point of the sheet substrate is reached. The fragrance solution is another important factor in the functioning of the present invention. Unlike the cleaning solutions used in the towelette dispenser systems, the fragrance solution of the present invention is specially formulated to provide the ability to dispense an aromatic scent into a room or within a given area. The fragrance solution is a water-based formula containing fragrance dispersion agents and a fragrance oil. Specifically, the fragrance solution contains water, a stabilizer, a quantity of fragrance, a solvent, a light stabilizer, a buffer, a preservative, and an antioxidant. Where the fragrance sheet is to serve double-duty as a cleaning sheet/wipe in addition to a room fragrance sheet, a chelating agent and a foaming agent may be added to the fragrance solution. The present invention's unique combination of sheet dispenser with a critically-sized sheet dispensing outlet and the specially formulated fragrance solution provides a new and previously unknown disposable sheet fragrance delivery system. The present invention takes advantage of the capillary action of the fragrance solution on the substrate sheet roll or stack. The capillary action begins in the base of the container where the fragrance solution permeates the base of the sheet roll or stack and moves upward through the sheet roll or stack toward the sheet that protrudes outward through the sheet dispensing outlet. A desired amount of sheet material is exposed to the air. The sheet dispensing outlet is sized so that, once the fragrance solution has permeated the protruding sheet, the fragrance is dissipated into the air within the room. To increase the amount of fragrance within a room, a user may pull up on the protruding sheet to increase its exposed length out of the dispenser, thus increasing the fragrance in the room. The exposed length may be increased again and again until the exposed fragrance sheet is entirely separated from the plurality of sheets within the container and removed from the container. Typically, the fragrance solution formulation and the size of the sheet are configured to be used for a period of about twenty-four hours. At which time, the sheet is removed and the next sheet is exposed to the air, rejuvenating the fragrance dispersion level. It should be noted that if the sheet is not removed, the capillary action of the fragrance solution up the sheet will continue to disperse fragrance into the air. Once removed from the container, the fragrance sheet may be placed in a drawer to impart fragrance into the drawer, hung over a hanger in a closet to impart fragrance into the closet, or placed in a trash receptacle to impart fragrance into the receptacle. The removed fragrance sheet may also be used as a fragrance wipe to impart a fragrance to the user's body. A cap may be optionally provided with the fragrance dispensing system and may optionally be attached to the container or to the sheet dispensing outlet to prevent removal of additional fragrance sheets and continuing loss of fragrance solution in the event that the fragrance dispensing system is stored. Multiple rolls or stacks of sheets may be placed into a compartmentalized container with an enlarged diameter, a corresponding multiple quantity of fragrance solution, and corresponding multiples of sheet dispensing outlets to impart fragrance into rooms of greater size. Alternatively, each compartment may contain a different fragrance-bearing formulation providing the user an option to select the fragrance sheets and the fragrance the user wishes to diffuse into the room. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a partial cut-away view of one embodiment of the room fragrance system of the present invention. FIGS. 2A and 2B are top views of useable sheet dispensing openings of the present invention. FIG. 3 is a cross-sectional view along the width of the embodiment in FIG. 1 . FIG. 4 is a cross-sectional view along the length of the embodiment in FIG. 1 . FIG. 5 is a side view of another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The preferred embodiment of the present invention is illustrated in FIGS. 1-5 . FIG. 1 shows the fragrance sheet dispenser system 10 of the present invention. Fragrance dispenser system 10 includes an enclosure 20 , a plurality of sheets 40 and a fragrance solution 60 . A portion 42 of one of the plurality of sheets 40 is shown protruding from sheet outlet 30 . Arrows 62 illustrate the dispersion of fragrance into the air. Enclosure 20 has a main body 22 , a bottom 24 and a top 26 . Top 26 may be a separate removable cover or it may be permanently fixed to main body 22 . Whether removable or not, top 26 includes a sheet dispensing outlet 30 through which each subsequent sheet is pulled by the user. Enclosure 20 can be any size or shape but is preferably at least three inches tall but less than twelve inches in height and twelve inches in diameter. Enclosure 20 may be made of any waterproof material, either natural or manmade, such as glass, ceramic, plastic, metal, composites, and the like. It should be understood that top 26 or bottom 24 may be made of a different material than body 22 . Top 26 or a portion of body 22 adjacent top 26 may optionally include decoratively-shaped openings to increase the dissipation of the fragrance solution into the air. Optional external finishes may be applied to the outside surface of enclosure 20 . Examples of such external finishes include frosted, painted, jeweled, or labeled finishes. Top 26 includes sheet dispenser outlet 30 . Turning now to FIGS. 2A and 2B , there is shown two embodiments of sheet dispenser outlet 30 . FIG. 2A includes a central, circular opening with four, equally-spaced elongated openings 30 a through which a single sheet is withdrawn. FIG. 2B includes a central circular opening 30 b through which a single sheet is withdrawn. Although the shape of the outlet 30 is not critical, the cross-sectional area of the opening is critical. For the present invention to function as a fragrance delivery system, it is important to have a cross-sectional area of about 0.19 square inches or larger. FIG. 3 shows a cross-sectional view of the embodiment in FIG. 1 . Within enclosure 20 , there is a plurality of disposable fragrance sheets 40 configured into a roll. Each sheet is partially separated from adjacent sheets with perforations (not shown) and the plurality of sheets is preferably of equal size. Each sheet is pulled from the center of the roll of sheets as indicated by sheet 41 . The substrate used as the plurality of sheets 40 is an airlaid, nonwoven material that may be made from materials such as wood pulp, rayon, and/or polyester fibers. The fibers may be oriented in one direction or in a random manner. The plurality of sheets 40 may be optionally dyed with a color to correspond to the scent of the fragrance solution. Turning now to FIG. 4 , there is illustrated a cross-sectional view of the present invention along its length. In this embodiment, the plurality of fragrance sheets 40 is in a roll where each sheet is withdrawn from enclosure 20 from the center of the roll. Sheet 41 is a representation of a fragrance sheet with perforations 45 that has a portion 42 extending from sheet dispensing outlet 30 . The plurality of sheets 40 are immersed in a fragrance solution 60 . Arrows 70 illustrate the capillary action of fragrance solution 60 up along fragrance sheet 41 to portion 42 where fragrance solution 60 then diffuses into the air as represented by arrows 62 . Fragrance solution 60 is composed of is a water-based formulation containing fragrance dispersion agents and a fragrance. In the present invention, the fragrance solution contains water, a stabilizer, a quantity of fragrance, a solvent, a light stabilizer, a buffer, a preservative, and an antioxidant. The water used in making fragrance solution 60 is tap water, and preferably deionized water. Typically, water makes up about 15-70% of the solution, and preferably from about 20-60%. Various surfactants may be used in fragrance solution 60 . Examples of acceptable surfactants are hydrotrope, sodium xylenesulphonate, dimethlbenzenesulfonic acid sodium salt, Conco SXS, Cyclophil SXS30, Eltesol SX30, Naxonate, Surco SXS, Ultrawet 40 SX, Calsoft SXS96, Alkatrope SX40, Carsoslf SXS, Eltesol SX93, Reworil NXS40, Richonate SXS, polyethylene glycol p-tert-octylphenyl ether, Triton X114, Witconate SXS, sodium sulfate, disodium sulfate, Triton 102, alpha-[(1,1,3,3-tetramethylbutyl)phenyl]-omega-hydroxypoly(oxy-1,2-ethanediyl), Bio-Terge, Amphosol, Betaine, trimethylammonioacetate, methnaminuim, Stepanol, steols, Bio-Soft, Marprosyl, sulfosuccinates, and sodium xylenesulfonate. The preferred surfactant is sodium xylenesulfonate and is available under the trademark Stepanate SXS from the Stepan Company of Northfield, Ill. Typically, the surfactant is present in the range of about 25% to about 75%, but preferably in the range of about 35% to about 65%. The fragrance is typically obtained from a fragrance supplier. For use in the present invention, the fragrance must be water-soluble. When the fragrance obtained is not water soluble, surfactants may be used to solubilize the oil-based fragrance into an aqueous solution. All as is well known by those of ordinary skill in the art. There are various fragrance suppliers known to those skilled in the art such as, for example, AromaTech of Sommerville, N.J., Noville of South Hackensack, N.J., Belmay, Inc. of Yonkers, N.Y., Wessel Fragrances of Elmwood, N.J., etc. The fragrance oil is typically present in the range of about 3% to about 22%, preferably in the range of about 4% to about 18% but most preferably in the range of about 5% to about 10%. The solvent is typically in the range of about 1% to about 20%. Preferably, the solvent is in the range of about 2% to about 10%. Examples of acceptable solvents are dipropylene glycol, butylene glycol, hexylene glycol, propylene glycol, isopropanol, dipentene, 3-methoxy-3-methyl-1-butanol, limonene, and benzyl benzoate. The preferred solvent is dipropylene glycol, which is available from various suppliers such as, for example, BASF Corporation, Dow Chemical, KIC Chemicals, Inc., to name a few. The light stabilizer concentration is in the range of about 0.0001% to about 0.05%, but preferably in the range of about 0.005% to about 0.01%. Examples of acceptable light stabilizers are octyl methoxycinnamate, benzophenone and benzotriazole derivatives. The preferred light stabilizer is a benzotriazole derivative available under the trademark TINOGARD™ APA from Ciba Specialty Chemicals. A buffer is added to the solution in the range of about 0.0% to about 1.2%. The preferred range is about 0.0% to about 0.05%. Buffers such as, for example, lactic acid, hydrochloric acid, phosphoric acid, stearic acid, sulfuric acid, and citric acid may be used. The preferred buffer for the present invention is citric acid. Citric acid may be obtained from a variety of suppliers including, but not limited to, Alfa Chem, Ameresco, Inc. Asiamerica International, Inc., Dastech International, Inc., Evergreen Corporation, Roche Vitamins, Inc., etc. The preservative in fragrance solution 60 is typically in the range of about 0.001% to about 1.1%, and preferably in the range of about 0.005% to about 1%. Examples of acceptable preservatives are benzoic acid, methylparaben, ethylparaben, propylparaben, alcohol SD40, alcohol SDA39-C-190, ethyl alcohol, triclosan, triclocarbon, phenoxyethanol, sodium hydroxymethylglycinate, and germaben. Sodium hydroxymethylglycinate available under the tradename SUTTOCIDE™ A from ISP Technologies, Inc. of Wayne, N.J., is the preferred preservative. An antioxidant is also included in fragrance solution 60 in the range of about 0.0% to about 0.1%, and preferably in the range of about 0.0% to about 0.05%. Butylated hydroxyanisol, tocopheryl acetate, vitamin E, and butylated hydroxytoluene are examples of acceptable antioxidants for use in the present invention. The preferred antioxidant is butylated hydroxytoluene. Butylated hydroxytoluene is readily available from suppliers such as, for example, Alfa Chem, Eastman Chemical Company, Shell Chemical Company, Spectrum Chemical Mfg. Co., etc. In another embodiment of the fragrance solution 60 of the present invention, the fragrance solution 60 may be formulated to serve double-duty as a cleaning sheet/wipe in addition to a room fragrance sheet. In this other embodiment, fragrance solution 60 may include in addition to the above-described components, a chelating agent and a foaming agent. Both the chelating agent and the foaming agent are typically present in the range of about 0% to about 15%, but preferably in the range of about 0% to about 10%. Depending on the fragrance oil used and the concentration of the other ingredients, a chelating agent and/or a foaming agent may not be required. Further, a disinfecting agent in the range of about 0.01% to about 15%, preferably in the range of about 1% to about 10%, may also be added to the fragrance solution. Examples of acceptable chelating agents include tetrasodium ethylenediaminetetraacetate, (ethylenedinitrilo) tetraacetic acid tetrasodium salt, disodium ethylenediaminediacetate, trisodium ethylenediaminetriacetate, trisodium nitrilotriacetate, sodium hydroxide, sodium glycolate, and versene. The preferred chelating agent is versene. Examples of acceptable foaming agents include diolamine, alkanolamide, diethanolamine, iminodiethanol, diethylolamine, bis-(2-hydroxyethyl)amine, ninol, cocoamide, and ammonyx. The preferred foaming agent is diethanolamine. Dyes may be added to fragrance solution 60 to match the color implied by the scent of the fragrance oil used. For example, adding an orange dye to fragrance solution 60 when orange-scented fragrance oil is used. Turning now to FIG. 5 , there is illustrated an example of another embodiment of the enclosure 20 . In this embodiment, enclosure 20 is a decoratively shaped container that may also included an external finish such as frosted, painted, jeweled, or labeled finish. Enclosure 20 may also have any shape to match the home décor. In addition to forming enclosure 20 into an aesthetically decorated container, enclosure 20 may also be configured as a replaceable insert that can be added to a decorative holder. In such a case, a disposable sheet fragrance kit can be provided that includes a decorative container with one or more replacement disposable sheet fragrance inserts. This allows the user to refill a decorative container or holder that the user does not wish to throw away. Although the preferred embodiments of the present invention have been described herein, the above description is merely illustrative. Further modification of the invention herein disclosed will occur to those skilled in the respective arts and all such modifications are deemed to be within the scope of the invention as defined by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application is a divisional of U.S. patent application Ser. No. 11/473,439, filed Jun. 23, 2006, which is pending. FIELD OF THE INVENTION The present invention relates to a food tray and a tray insert adapted to be removably located in a food holding compartment that may be used to keep food heated or cooled for an extended period of time and associated methods of using such devices. BACKGROUND OF THE INVENTION Many quick-service restaurants must prepare a high volume of food relatively quickly. These restaurants face a number of conflicting factors when striving to efficiently provide fast, palatable, and safe food. Customers expect to receive their food quickly and with predictable and constant high quality. Moreover, the rate of customer demand varies over time, with some periods, such as lunch and dinner times, having extremely high rates of customer demand. However, the kitchens of many quick-service restaurants are of limited size and/or production capacity and have a limited number of cooking devices. To meet the often competing factors of quick service while producing a consistently high quality product, it is advantageous for one individual to cook a relatively substantial amount of food product in bulk and store the cooked food product in food trays while another individual food preparer transfers food from the trays to a sandwich bun or individual portion sized container to fill customer orders. Typical food products that are of most interest to have readily available for food preparers include sandwich fillings such as hamburger patties, chicken patties, breaded chicken patties, breaded fish fillets, Canadian bacon, pork sausage, and eggs, for example. Because these prepared food products are not being served immediately upon preparation, it is critical to store the food product so as to maximize potential storage time while optimally maintaining the appearance, taste, temperature, and texture of the food product, as well as minimizing bacterial contamination of the stored food product. In view of the foregoing, there exists a need for an improved food tray, tray insert, and a method of using the food tray and tray insert that provides longer storage times and optimizes, without significant adverse effects, the appearance, taste, temperature and texture of the pre-cooked food products, as well as minimizes bacterial contamination of such stored food products. Additionally, a need also exists for a food staging device that promotes efficient food handling and use of space within the kitchen of a quick-service restaurant. SUMMARY OF THE INVENTION In accordance with the present invention, an improved food tray and method for use thereof, typically in connection with a compartment, and preferably in a heated pass-through compartment, for holding ready-to-serve food product is provided. When used in combination with a compartment of desirable configuration, the food tray is particularly useful for storing over an extended period of time cooked sandwich fillings such as, for example, hamburger patties, fish fillets, Canadian bacon, pork sausage, eggs, and chicken patties, chicken fillets as well as other types of food, including chicken nuggets, biscuits, muffins, and hotcakes. The appearance, taste, temperature and texture of the stored food items may be maintained over extended storage periods while also minimizing risk of bacterial contamination. In one aspect of the invention, a food tray is provided which is adapted to store individual portions of food over extended storage periods within a storage compartment. The food tray includes a tray body and a tray insert. The tray body includes a first end, a second end, a lower surface tray bottom, and a sidewall structure. The tray bottom and sidewall structure define a tray volume or cavity for the food tray within which a tray insert can be added and within which food product can be stored. The tray insert is positionable within the tray volume and includes an elongated supporting surface and insert supports. The supporting surface and insert supports define a tray insert height wherein the supporting surface is above the tray bottom lower surface and is below the top of the sidewall structure. The lower surface defines a volume between the lower surface and the supporting surface. The supporting surface defines a food holding volume in conjunction with the sidewall structure. The tray insert is positioned within the food tray leaving only a small gap between the sidewall structure and the supporting surface. While the gap can be as desired, preferably, the gap is less than approximately 0.1 inch, where the tray insert is a functional fit within the food tray. The sidewall structure of the food tray can be any suitable height. The sidewall height can be as desired and preferably, the sidewall structure is approximately 2.125 inches high. The height between the tray bottom and the supporting surface typically can be between approximately 10% and 80% of the overall height of the sidewall structure. For example, the tray insert height can be approximately one inch less than the tray height, where the tray height is the overall height of the sidewall structure. Typically, the height between the tray bottom and the supporting surface is approximately 50% of the overall height of the sidewall structure. In accordance with another aspect of the invention, the supporting surface is a generally flat surface and comprises a plurality of apertures thereon. The apertures can be any shape or size. Typically, the apertures are arrayed in a generally overall circular shape which overall circular shape corresponds generally to the diameter of hamburger patties to be stored thereon. The apertures can be any shape or size as appropriate for the cooked food that will be stored on the supporting surface. For example, the individual apertures can be slits, generally oblong, rectangular, triangular, or circular. Typically, the individual apertures are generally rectangular, triangular, or circular. In accordance with another aspect of the invention, hamburger patties are stacked two patties high on the supporting surface. Typically, eight hamburger patties that are weighted ten hamburger patties per pound of meat are stacked two patties high on the supporting surface. Typically, six hamburger patties that are weighted four hamburger patties per pound of meat are stacked two patties high on the supporting surface. In accordance with another aspect of the invention, the supporting surface comprises a plurality of apertures that form a generally circular shape generally corresponding to the size of hamburger patties to be stored thereon. The supporting surface may contain any number of generally circular shaped series of apertures as appropriate. Typically, the supporting surface has three generally circular shaped series of apertures. Typically, at least one cooked hamburger patty essentially covers the circular shaped series of apertures. Preferably, the food tray comprises a plurality of cooked hamburger patties contained in the tray on the supporting surface and essentially covering the apertures. In accordance with another aspect of the present invention, a food tray is provided which is adapted to store individual portions of food over extended storage periods within a storage compartment. A tray insert is provided that is an integral part of the tray body. The tray insert comprises a supporting surface. The supporting surface is located above the tray bottom lower surface and below the top of the sidewall structure. The supporting surface and lower surface define a volume, wherein the volume is a sealed void. In accordance with another aspect of the present invention, a method of storing food, preferably cooked food, within a food tray in a heated compartment is provided. Preferably, the heated compartment is a pass-through compartment having a passageway which extends from an opening on one end of the heated compartment to an opening on an opposite end of the heated compartment. A food tray is provided which is adapted to store individual portions of food over extended storage periods within a storage compartment. The food tray includes a tray body and a tray insert. The tray body includes a first end, a second end, a lower surface tray bottom, and a sidewall structure. The tray bottom and sidewall structure define a tray volume or cavity for the food tray within which a tray insert can be added and within which food product can be stored. The tray insert is positionable within the tray volume and includes an elongated supporting surface and insert supports. The supporting surface and insert supports define a tray insert height wherein the supporting surface is above the tray bottom lower surface and is below the top of the sidewall structure. The lower surface defines a volume between the lower surface and the supporting surface. The supporting surface defines a food holding volume in conjunction with the sidewall structure. Individual portions of food, such as, for example, hamburger patties, fish fillets, Canadian bacon, pork sausage, eggs, and chicken patties, chicken fillets as well as other types of food, including chicken nuggets, biscuits, muffins, and hotcakes, are placed on the supporting surface. The food tray having the individual portions of food stored therein is placed and stored for a period of time in a heated compartment having an upper compartment surface and a heated lower compartment surface to maintain the temperature of the cooked food products in a desired elevated storage temperature range, wherein the supporting surface is elevated above the heated lower compartment surface. The food tray is maintained during storage so that the top edge of the tray is in close proximity to the upper compartment surface to achieve a gap between the top of the tray and the upper compartment surface of between about 0 and 0.25 inches. Preferably, the lower volume avoids significant convection heat transfer between said heated lower compartment surface and said individual portions of food. Preferably, the gap is sufficiently sized to restrict water vapor from evaporating from the cooked food in the tray during storage in the compartment. Typically, the supporting surface is a generally flat surface and may comprise a plurality of apertures thereon. The apertures can be any shape or size. Typically, the apertures are arrayed in a generally overall circular shape which overall circular shape corresponds generally to the diameter of hamburger patties to be stored thereon. The apertures can be any shape or size as appropriate for the cooked food that will be stored on the supporting surface. For example, the individual apertures can be slits, generally oblong, oval, rectangular, triangular, or circular. Typically, the individual apertures are generally rectangular, triangular, or circular. In accordance with another aspect of the present invention, a method of storing previously cooked hamburger patties after cooking and before incorporation into a hamburger sandwich within a food tray in a heated compartment is provided. Preferably, the heated compartment is a pass-through compartment having a passageway which extends from an opening on one end of the heated compartment to an opening on an opposite end of the heated compartment. A food tray is provided which is adapted to store individual portions of food over extended storage periods within a storage compartment. The food tray includes a tray body and a tray insert. The tray body includes a first end, a second end, a lower surface tray bottom, and a sidewall structure. The tray bottom and sidewall structure define a tray volume or cavity for the food tray within which a tray insert can be added and within which food product can be stored. The tray insert is positionable within the tray volume and includes an elongated supporting surface and insert supports. The supporting surface and insert supports define a tray insert height wherein the supporting surface is above the tray bottom lower surface and is below the top of the sidewall structure. The lower surface defines a volume between the lower surface and the supporting surface. The supporting surface defines a food holding volume in conjunction with the sidewall structure. Individual portions of food, such as hamburger patties, are placed on the supporting surface. The food tray having the individual portions of food stored therein is placed and stored for a period of time in a heated compartment having an upper compartment surface and a heated lower compartment surface to maintain the temperature of the cooked food products in a desired elevated storage temperature range, wherein the supporting surface is elevated above the heated lower compartment surface. Typically, the cooked hamburger patties are maintained at a storage temperature of approximately 145° F. The food tray is maintained during storage so that the top edge of the tray is in close proximity to the upper compartment surface to achieve a gap between the top of the tray and the upper compartment surface of between about 0 and 0.25 inches to restrict water vapor from evaporating from the cooked hamburger patties in the tray during storage in the compartment. Preferably, the lower volume avoids significant convection heat transfer between said heated lower compartment surface and said individual portions of food. Preferably, the gap is sufficiently sized to restrict water vapor from evaporating from the cooked food in the tray during storage in the compartment. Typically, the supporting surface is a generally flat surface and may comprise a plurality of apertures thereon. The apertures can be any shape or size. Typically, the apertures are arrayed in a generally overall circular shape which overall circular shape corresponds generally to the diameter of hamburger patties to be stored thereon. The apertures can be any shape or size as appropriate for the cooked food that will be stored on the supporting surface. For example, the individual apertures can be slits, generally oblong, oval, rectangular, triangular, or circular. Typically, the individual apertures are generally rectangular, triangular, or circular. Typically, the method of storing previously cooked hamburger patties after cooking and before incorporation into a hamburger sandwich within a food tray in a heated compartment further comprises storing the hamburger patties in the food tray until the hamburger patties are assembled into hamburger sandwiches. Preferably, hamburger patties are stacked on the supporting surface two hamburger patties high. Typically, either six or eight hamburger patties are stored on the supporting surface in the food tray. In accordance with another aspect of the present invention, a method of making a hamburger sandwich is provided. A plurality of hamburger patties is cooked. A food tray is provided which is adapted to store individual portions of food over extended storage periods within a storage compartment. The food tray includes a tray body and a tray insert. The tray body includes a first end, a second end, a lower surface tray bottom, and a sidewall structure. The tray bottom and sidewall structure define a tray volume or cavity for the food tray within which a tray insert can be added and within which food product can be stored. The tray insert is positionable within the tray volume and includes an elongated supporting surface and insert supports. The supporting surface and insert supports define a tray insert height wherein the supporting surface is above the tray bottom lower surface and is below the top of the sidewall structure. The lower surface defines a volume between the lower surface and the supporting surface. The supporting surface defines a food holding volume in conjunction with the sidewall structure. Individual portions of food, such as previously cooked hamburger patties are placed on the supporting surface. The food tray having the individual portions of food stored therein is placed and stored for a period of time into a heated compartment having an upper compartment surface and a heated lower compartment surface to maintain the temperature of the cooked food products in a desired elevated storage temperature range, wherein the supporting surface is elevated above the heated lower compartment surface. Typically, the cooked hamburger patties are maintained at a storage temperature of approximately 145° F. The food tray is maintained during storage so that the top edge of the tray is in close proximity to the upper compartment surface to achieve a gap between the top of the tray and the upper compartment surface of between about 0 and 0.25 inches to restrict water vapor from evaporating from the cooked hamburger patties in the tray during storage in the compartment. Thereafter, the cooked hamburger patties are removed from the tray when needed for assembly into hamburger sandwiches and the hamburger patties are assembled into hamburger sandwiches. Typically, assembling the hamburger patties into sandwiches comprises applying condiments and placing the hamburger patties into buns. The supporting surface may comprise a plurality of apertures which may be any potential shape, such as ovals, circles, slits, or rectangles. Typically, the apertures are arranged in a generally circular shape, such that hamburger patties essentially cover the apertures. Typically, hamburger patties are stored on the supporting surface two hamburger patties high. Any number of hamburger patties can be stored in the food tray. Typically, six or eight hamburger patties are stored on the supporting surface of the food tray. BRIEF DESCRIPTION OF THE FIGURES The accompanying drawings form part of the specification and like numerals are employed to designate like parts throughout the same. FIG. 1 is a perspective view of an embodiment of the tray insert in accordance with the invention. FIG. 2 is a perspective view of another embodiment of the tray insert in accordance with the invention. FIG. 3 is a perspective view of an embodiment of the food tray and tray insert in accordance with the invention. FIG. 4 is a perspective view of another embodiment of the food tray and tray insert in accordance with the invention. FIG. 5 is a perspective view with a cut-away portion of another embodiment of the food tray and tray insert in accordance with the invention. FIG. 6 is a perspective view with a cut-away portion of another embodiment of the food tray and tray insert in accordance with the invention. FIG. 7 is a perspective view with a cut-away portion of another embodiment of the food tray in accordance with the invention. FIG. 8 is a perspective view of another embodiment of the tray insert in accordance with the invention. FIG. 9 is a perspective view of another embodiment of the tray insert in accordance with the invention. FIG. 10 is a perspective view of a method of using the food tray and tray insert in accordance with the invention. FIG. 11 is a perspective view of another embodiment of the method of using the food tray and tray insert in accordance with the invention. FIG. 12 is a perspective view of a method of making a sandwich in accordance with the invention. FIG. 13 is a side elevation view of another embodiment of the tray in accordance with the invention. FIG. 14 is a side elevation view of another embodiment of the tray in accordance with the invention. DETAILED DESCRIPTION OF THE INVENTION While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and described in detail herein, several specific embodiments with the understanding that the present disclosure is to be considered as exemplifications of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. U.S. Pat. Nos. 5,590,586, 5,724,886, 5,947,012, 6,119,587, 6,209,447, 6,358,548 and 6,607,766 are hereby expressly incorporated by reference. Referring to the figures generally, and in particular to FIG. 1 , a tray insert 10 according to the present invention is shown generally as having a tray insert body 12 . Tray body 12 comprises a supporting surface 14 and a plurality of insert supports 16 a - d . Insert supports 16 a - d give tray insert 10 height. Supporting surface 14 is a generally flat surface. Supporting surface 14 further comprises a plurality of apertures 18 to form a generally circular shape generally corresponding to the size of cooked food portions to be stored thereon. Apertures 18 can be any shape, size, or number as appropriate for the cooked food that will be stored on supporting surface 14 . Typically, apertures 18 define a total void space opening of at least 30%. More typically, apertures 18 define a total void space opening of at least 50%. Referring to the figures generally, and in particular to FIG. 2 , a tray insert 30 according to the present invention is shown generally as having a tray insert body 32 . Tray body 32 comprises a supporting surface 34 and a plurality of insert supports 36 a - d . Insert supports 36 a - d give tray insert 30 height. Supporting surface 34 is a generally flat surface that would support a cooked food portion. Tray body 32 may further comprise at least one finger opening 38 a - b . Finger openings 38 a - b allow for tray insert 30 to be easily placed into or removed from a food tray. Finger openings 38 a - b can be any shape to allow a finger and/or thumb to easily grip tray insert 30 . Typically, finger openings 38 a - b are semi-circular in shape. Referring in particular to FIG. 3 and FIG. 4 , a food tray 40 is provided according to the present invention and is shown generally as having a tray bottom lower surface 42 . Food tray 40 further comprises a sidewall structure 44 . Sidewall structure 44 and tray bottom lower surface 42 define a tray volume 46 . Tray insert 10 or 30 can be inserted into food tray 40 . Hamburger patties H and H 2 sit on top of supporting surfaces 14 and 34 , respectively. Referring in particular to FIG. 5 , a food tray 60 is provided according to the present invention and is shown generally as having a lower surface 62 . Food tray 60 further comprises a sidewall structure 64 . Sidewall structure 64 and lower surface 62 define a tray volume 66 . Food tray 60 further comprises a tray insert 68 , inserted into food tray 60 . Tray insert 68 comprises a supporting surface 70 and insert supports 72 a - d . Any number of insert supports can be present as necessary to support tray insert 68 . Typically, insert supports 72 a - d prevent tray insert 68 from sagging in the middle, keeping supporting surface 70 essentially generally straight. Supporting surface 70 and lower surface 62 define a lower volume 73 . Lower volume 73 can be any percentage of tray volume 66 as desired, from about 0% to about 90%. Typically, lower volume 73 is approximately 50% of the overall tray volume. Tray insert 68 further comprises a plurality of apertures 74 . Any number of apertures as desired may be on tray insert 68 . The plurality of apertures may be any potential, suitable shape, such as, for example, ovals, circles, slits, or rectangles. Typically, the apertures are arranged in a generally circular shape, such that hamburger patties essentially cover the apertures. Typically, the apertures are arranged to form a generally circular shape approximately the size of a hamburger patty. Typically, the apertures will be essentially completely covered by at least one hamburger patty. Tray insert 68 further comprises a plurality of hamburger patties H located on supporting surface 70 and essentially completely covering apertures 74 . Referring in particular to FIG. 6 , a food tray 80 is provided according to the present invention and is shown generally as having a lower surface 82 . Food tray 80 further comprises a sidewall structure 84 . Sidewall structure 84 and lower surface 82 define a tray volume 86 . Food tray 80 further comprises a tray insert 88 , inserted into food tray 80 . Tray insert 88 comprises a supporting surface 90 and insert supports 92 a - d . Any number of insert supports can be present as necessary to support tray insert 88 . Typically, insert supports 92 a - d prevent tray insert 88 from sagging in the middle, keeping supporting surface 90 essentially generally straight. Supporting surface 90 and lower surface 82 define a lower volume 93 . Lower volume 93 can be any percentage of tray volume 86 as desired, typically, for example, from about 0% to about 90% of the overall tray volume. Typically, lower volume 93 is approximately 50% of the overall tray volume. Tray insert 88 further comprises finger grips 94 a - b on opposite ends of tray insert 88 . Finger grips 94 a - b allow tray insert 88 to be easily removed from or inserted into food tray 80 . Finger grips 94 a - b can be any size and shape to facilitate a typical human finger. Typically, the finger grips are semi-circular in shape, as shown in finger grips 94 a - b . Tray insert 88 further comprises a plurality of hamburger patties H 2 located on supporting surface 90 . Referring in particular to FIG. 7 , a food tray 100 is provided according to the present invention and is shown generally as having a lower surface 102 and supporting sidewalls 104 . Lower surface 102 and supporting sidewalls 104 define a tray volume 106 . Food tray 100 further comprises an integral tray insert 108 . Tray insert 108 is an integral part of food tray 100 and is not removable from food tray 100 . Tray insert 108 comprises a supporting surface 108 ′. Supporting surface 108 ′ of tray insert 108 and lower surface 102 of tray 100 together define a lower volume 110 . Lower volume 110 can be any percentage of tray volume 106 as desired, typically, for example, from about 0% to about 90% of the overall tray volume. Typically, lower volume 110 is approximately 50% of the overall tray volume. Lower volume 110 allows supporting surface 108 ′ of tray insert 108 to be elevated above lower surface 102 , such that any food portions placed upon supporting surface 108 will not be directly adjacent any heat source contacting lower surface 102 . By defining lower volume 110 and not directly contacting any food portions placed on supporting surface 108 with the heated lower surface 102 , the food portions can be stored in food tray 100 for extended periods of time. Referring to FIG. 8 , a tray insert 109 according to the present invention is shown generally as having a tray insert body 111 . Tray body 111 comprises a supporting surface 112 and a plurality of insert supports 114 a - d . Insert supports 114 a - d give tray insert 109 height. Supporting surface 112 is an essentially generally flat surface. Supporting surface 112 further comprises a plurality of apertures 116 to form a generally circular shape generally corresponding to the diameter or footprint of cooked food portions to be stored thereon. Apertures 116 are generally circular in shape as appropriate for the cooked food that will be stored on supporting surface 112 and form an overall generally circular shape approximately the size and shape of a hamburger patty. Typically, apertures 116 define a total void space opening of at least 30%. More typically, apertures 116 define a total void space opening of at least 50%. Referring to FIG. 9 , a tray insert 120 according to the present invention is shown generally as having a tray insert body 121 . Tray body 121 comprises a supporting surface 122 and a plurality of insert supports 124 a - d . Insert supports 124 a - d give tray insert 120 height. Supporting surface 122 is an essentially generally flat surface. Supporting surface 122 further comprises a plurality of apertures 126 to form a generally circular shape generally corresponding to the size of the cooked food portions to be stored thereon. Apertures 126 are generally triangular in shape as appropriate for the cooked food that will be stored on supporting surface 122 and form an overall generally circular shape approximately the size and shape of a hamburger patty. Typically, apertures 126 define a total void space opening of at least 30%. More typically, apertures 126 define a total void space opening of at least 50%. Referring to FIG. 13 , a tray body 180 is provided. Tray body 180 comprises a tray bottom lower surface 182 and supporting sidewalls 183 . Lower surface 182 and supporting sidewalls 183 define a tray volume 184 . Tray body 180 further comprises finger grips 186 a - b . Individual food portions 188 a - f are contained within food tray 180 , located on lower surface 182 . Tray body 180 has an overall height X. Individual food portions have a food portion height Y. Food portion height Y can be any height equal to or less than overall height X. Typically, food portion height Y is one half of overall height X. Referring to FIG. 14 , a tray body 200 is provided. Tray body 200 comprises supporting sidewalls 202 , a lower surface 203 , and tray legs 204 . Lower surface 203 and tray legs 204 further define a lower volume 205 . Tray body 200 further comprises finger grips 206 a - b . Lower surface 203 and supporting sidewalls 202 further define a tray volume 208 . Individual food portions 210 a - f are located on lower surface 203 within tray volume 208 . Tray body 200 is resting on a lower compartment surface 212 . Lower volume 205 is further bound and defined by lower compartment surface 212 . Lower volume 205 has a supporting surface height Z. Height Z can be any suitable height to prevent direct contact of lower surface 203 with lower compartment surface 212 . Referring to FIG. 10 , a method of storing individual portions of food is provided. A universal holding cabinet 130 is provided to store individual portions of food. A food tray 132 is provided. Food tray 132 comprises a tray insert 134 that is elevated above the lower surface of food tray 132 . Tray insert 134 comprises a supporting surface 136 and finger grips 138 . Supporting surface 136 allows for the storage and placement of individual portions of food H 2 . Individual portions of food H 2 are placed on supporting surface 136 . Food tray 132 is inserted into one of heated compartments 142 a - c in universal holding cabinet 130 . Heated compartments 142 a - c comprise a heated lower compartment surface 144 . Food tray 132 is stored in one of heated compartments 142 a - c for a period of time, maintaining the temperature of the cooked food products in a desired elevated storage temperature range. Referring to FIG. 11 , a method of storing previously cooked hamburger patties after cooking and before incorporation into a hamburger sandwich is provided. A universal holding cabinet 150 is provided to store individual portions of food. Food trays 152 a - d are provided. Universal holding cabinet 150 is a pass-through design, allowing food trays 152 a - d to be inserted into and removed from either side of universal holding cabinet 150 . Food trays 152 a - d further comprise supporting surface 154 . Individual hamburger patties H are placed upon supporting surface 154 and inside food tray 152 b. Referring to FIG. 12 , a method of making a hamburger sandwich is provided. Food tray 80 is provided which comprises tray volume 86 and tray insert 88 . Tray insert 88 further comprises supporting surface 90 and finger grips 94 a - b . Hamburger patties H 2 are supported upon supporting surface 90 . Hamburger patty H 2 is on spatula S and is removed from food tray 80 . Preparation of the hamburger sandwich occurs in work space 160 . The hamburger patties H 2 are assembled into hamburger sandwiches by applying condiments C and a bottom bun BB and a bun cap BC. Bottom bun BB, bun cap BC, condiments C, and hamburger patty H 2 are placed together to prepare a hamburger sandwich. While the invention has been described with respect to certain preferred embodiments, as will be appreciated by those skilled in the art, it is to be understood that the invention is capable of numerous changes, modifications and rearrangements, and such changes, modifications and rearrangements are intended to be covered by the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is based upon and claim the benefit of priority from the prior U.S. Provisional Application No. 62/269,762 filed Dec. 18, 2015, 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 a method for ankle arthrodesis using an ultrasonic treatment tool. [0004] 2. Description of the Related Art [0005] In arthroscopic surgery, portals as small holes are generally made in a few locations around a joint (skin surface) and an arthroscope, a treatment tool and the like are inserted into these portals. Then, surgery is performed while videos in a monitor being checked in a state in which the inside of the joint is filled with a perfusion such as saline. [0006] In arthroscopic surgery using such conventional treatment tools, there are causes for concern about some procedures. For example, if a drill or the like is used to make a bone hole, a hole is made only in a traveling direction of a drill blade and thus, when a bone hole is made inside a joint, an installation direction is limited by the position of a site to be treated. A treatment tool that cuts in a plane direction using a rotary blade cuts a bone by moving the rotary blade while rotating and thus, unevenness is left on the treatment surface and it is not easy to smooth the surface. Further, when a treatment tool using high frequencies is used, if thermal damage extending over surrounding tissues including the tissue to be treated is caused, it takes time before the postoperative condition becomes good. BRIEF SUMMARY OF THE INVENTION [0007] A method for ankle arthrodesis in an embodiment according to the present invention includes: removing a cartilage of a talus using an ultrasonic vibration of an ultrasonic probe; creating a dimple using the ultrasonic probe in a region from which the cartilage of the talus has been removed; removing a cartilage of a tibia using an ultrasonic vibration of the ultrasonic probe; creating a dimple using the ultrasonic probe in a region from which the cartilage of the tibia has been removed; and fixing the talus and the tibia (using screws) while the region where the dimple of the talus is created and the region where the dimple of the tibia is created are in contact. [0008] Advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out hereinafter. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0009] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention, and together with the general description given above and the detailed description of the embodiments given below, serve to explain the principles of the invention. [0010] FIG. 1 is a diagram showing a configuration example of an operation system including an ultrasonic treatment tool to perform ankle lateral ligament reconstruction according to an embodiment; [0011] FIG. 2 is a diagram showing a state in which an arthroscope and a surgical instrument are inserted into an anterolateral inserting point and an anteromedial inserting point; [0012] FIG. 3A is a diagram showing a configuration example of a probe provided with a treatment section having a rectangular opening; [0013] FIG. 3B is a diagram showing a configuration example of the probe provided with the treatment section having a curette for ultrasonic vibration; [0014] FIG. 3C is a diagram showing a configuration example of the probe provided with the treatment section having a plurality of steps of edges formed thereon; [0015] FIG. 3D is a diagram showing a configuration example in which the tip of the treatment section of the probe has a circular shape; [0016] FIG. 3E is a diagram showing a configuration example in which the tip of the treatment section of the probe has an elliptic shape; [0017] FIG. 3F is a diagram showing a configuration example in which the tip of the treatment section of the probe has a long hole shape; [0018] FIG. 3G is a diagram showing a configuration example in which the tip of the treatment section of the probe has a rectangular shape; [0019] FIG. 4 is a diagram showing positions where an anterolateral inserting point and an anteromedial inserting point are created; [0020] FIG. 5 is a diagram showing a state in which holes are formed in a subchondral bone plate by an ultrasonic treatment tool in which the tip of the treatment section of the probe is bent and has a needle shape; [0021] FIG. 6 is a diagram illustrating a fixed state of the tibia and the talus by a method for ankle arthrodesis according to the present embodiment; [0022] FIG. 7 is a diagram illustrating the fixed state of the tibia and the talus by a conventional method for ankle arthrodesis for comparison; [0023] FIG. 8 is a diagram showing the fixed state of the tibia and the talus fixed by the method for ankle arthrodesis according to the present embodiment; [0024] FIG. 9 is a diagram showing the fixed state of the tibia and the talus fixed by the conventional method for ankle arthrodesis for comparison; and [0025] FIG. 10 is a flow chart illustrating surgical steps of the method for ankle arthrodesis. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0026] Hereinafter, a method for arthroscopic ankle arthrodesis using an ultrasonic treatment tool according to an embodiment of the present invention will be described with reference to the drawings. [0027] FIG. 1 shows a configuration example of an operation system including an ultrasonic treatment tool to perform a method for arthroscopic ankle arthrodesis according to the present embodiment. FIG. 2 is a diagram showing a state in which an arthroscope and an ultrasonic treatment tool are inserted into an anterolateral inserting point and an anteromedial inserting point. In the present embodiment described below, a site to be treated 100 will be described by taking an ankle as an example, but the present embodiment is not limited to the ankle and other joints can similarly be operated on easily using the ultrasonic treatment tool. [0028] An operation system 1 according to the present embodiment includes an ultrasonic treatment tool 2 and an endoscopic system 3 including an arthroscope 21 . [0029] The ultrasonic treatment tool 2 includes an the ultrasonic wave generating section 11 that generates an ultrasonic vibration using an ultrasonic vibration element (for example, a piezoelectric element), a probe 12 that performs the ultrasonic treatment procedure of the site to be treated by transmitting the ultrasonic vibration, and an operation section 13 that performs an ON/OFF operation of the generation of an ultrasonic vibration by exercising drive control of the ultrasonic wave generating section 11 . [0030] The endoscopic system 3 includes the arthroscope 21 rigid endoscope, a visible light source 22 that radiates an illumination light of visible light as a light source of illumination light, a controller 23 that controls the endoscopic system 3 as a whole, an input section 24 such as a keyboard or a touch panel, a display section 25 that displays surgery information including imaged surgery conditions, and a water-supply/water-discharge section 26 that supplies physiological saline to the ankle lateral ligament of a site to be treated 100 and surroundings thereof or drains or perfuses physiological saline. [0031] In the present embodiment, the water-supply/water-discharge section 26 is configured to supply physiological saline to the site to be treated through the arthroscope 21 or drain physiological saline, but a perfusion containing physiological saline or the like may be supplied or drained from the ultrasonic treatment tool 2 . [0032] As illustrated in FIG. 2 , the probe 12 used in the present embodiment is an elongated rod-like member of about 2 mm to 4 mm in diameter extending linearly in a longitudinal direction and has a tip portion and a base end. The base end is linked to the ultrasonic wave generating section 11 and the tip portion is provided with a treatment section 14 that excises the cartilage. [0033] The treatment section 14 of the probe 12 of the ultrasonic treatment tool 2 will be described. [0034] The treatment section 14 provided at the tip of the probe 12 illustrated in FIG. 3A has a shape in which an inverted isosceles trapezoid expands upward from below and an upper base of the trapezoid on the lower side is an opening 14 c in a rectangular shape that cuts by being brought into contact with a site to be treated and a lower base of the trapezoid on the upper side is an opening to be an outlet of filing. Edges 14 d are provided at respective ends of the opening 14 c where inclined planes (legs) 14 a , 14 b inclined opposite to each other like expanding are in contact. These edges 14 d function like a planer blade and can cut the site to be treated. Thus, the treatment section 14 of the probe 12 is structured to perform not only ultrasonic treatment S 1 by a pull operation, but also an ultrasonic treatment S 2 by a push operation by providing cutting edges forward and backward in a traveling direction of an opening that ablates the cartilage. [0035] An edge is provided only on a tip side of an opening in a conventional curette and thus, after pulling nearer for the ultrasonic treatment, an operation to return to the original cutting start position is needed. To cut a surface 101 , for example, a cutting operation of 5-time reciprocation is needed. [0036] In contrast, the treatment section 14 according to the present embodiment can cut both ways and thus, when a surface 102 having the same area as the surface 101 , a cutting operation of 2-and-half-time reciprocation is needed. That is, the ultrasonic treatment procedure of 5-time reciprocation is reduced to the ultrasonic treatment procedure of 2-and-half-time reciprocation for the same area and thus, the treatment section 14 according to the present embodiment has substantially 2-time cutting capacities when compared with the conventional curette and can make the dissection treatment more efficient. [0037] FIG. 3B shows a configuration example in which the structure of the treatment section 14 in FIG. 3A is applied to an ultrasonic vibration curette 15 by providing the structure at the tip of the probe 12 . If the curette 15 is produced with a thin blade of about 2 to 3 mm in thickness or by being bent, the cartilage and bone on a tibia surface and talus surface curved inside a joint fissure expanded to about 4 to 5 mm can be cut by being in traction in a state of ultrasonic vibration. The curette 15 may have elastically deforming characteristics to suitably adjust a pressing force. [0038] FIG. 3C shows a treatment section 17 having a plurality of steps of edges 16 formed by a plurality of parallel grooves so as to rotate in a direction intersecting a longitudinal axis as a vibration direction of the probe 12 . By providing edges on both sides of edges in the treatment section 17 , the cartilage and bone are cut in both push and pull directions. [0039] The probe 12 illustrated in FIG. 3D is provided with a treatment section 19 that opens a bone hole at the tip thereof and has protrusions 19 c in a rectangular shape arranged checkerwise on the side face extending about halfway around the probe 12 . The treatment section 19 has an apical protrusion 19 a longer than other protrusions to align with a guide hole formed in advance arranged in the center of the tip surface and a plurality of protrusions 19 b arranged therearound. [0040] The treatment section 19 can carry out a cutting procedure of bones (cortical bones and cancellous bones) the cartilage and subchondral bone and all sites of living body tissues. That is, the cartilage can be shaved off by dissolution the cartilage using frictional heat generated between the treatment section 19 and the cartilage when the protrusions 19 c made of edges formed on the side face of the probe 12 are put thereon. In addition, the bone is cut by being hammered by the protrusions 19 b of the treatment section 19 provided at the tip of the probe 12 like ultrasonic vibration and extremely finely smashed and then shaved off. Therefore, by fitting the treatment section 19 at the tip of the probe to a shape matching an object to be cut, not only the type of the site to be cut, but also the amount of cutting and the shape thereof can appropriately be selected. Incidentally, though the amount of cutting is smaller than that of the protrusions 19 b , the protrusions 19 c provided on the side face of the probe 12 can knock and cut the bone. [0041] A conventional drill used to form a bone hole opens a hole by rotation and thus, the basic shape of the hole is circular and even if the drill is moved in the left and right direction, the result is only an increased diameter in an indefinite shape and a desired shape cannot be formed. In contrast, the probe 12 of the ultrasonic treatment tool 2 does not rotate and moves infinitesimally in a forward and backward direction and thus, if the probe tip is hit against a bone and knocked vertically with respect to the bone surface, the bone hole is not limited to a circular shape and a bone hole in a shape matching the external shape of the treatment section (or a sectional shape of the probe) can be formed. By moving the location where the treatment section 19 is hit, a bone hole in any shape can be formed. If the shape of a bone hole to be formed is determined, for example, as illustrated in FIG. 3E , a bone hole in any shape can be formed by external appearance of a treatment section 20 provided with an apical protrusion 20 a and a plurality of protrusions 20 b at the tip of the probe 12 in an elliptic shape. In this example, grooves 20 c are arranged so as to be arrayed in two rows in the longitudinal direction on the side face of the probe 12 to constitute edges for cutting. Similarly, a treatment section 20 d in a long hole shape (track shape) illustrated in FIG. 3F or a treatment section 20 e in a rectangular shape illustrated in FIG. 3G can form a bone hole in a shape matching the shape of the treatment section. [0042] Further, the bone hole is not limited to a linear shape and a bone hole having a curved portion can also be formed. When, for example, a problem of being unable to fix a tendon or the like arises because only a short length (depth) of a bone hole can be taken depending on the shape of the bone if the bone hole is linear, fixing may be enabled by forming a curved bone hole. A bone hole having a curved portion can be implemented by using a probe having a curve in a tip portion. [0043] Regarding the diameter or width of a bone hole, not only holes of the same diameter or the same width, but also holes in a tapering shape of the diameter or width from the inlet can be formed. In this case, the tapering shape can be formed with steps or without steps. If the probe tip having edges is pressed horizontally against the surface of a bone, vibrations occur like knocking while sliding on the treatment surface of a site to be treated and thus, the site can be excised by knocking and shaving off using edges. If the site to be treated has elasticity like the cartilage or fat, the site can be excised by shaving off using edges and fusing by frictional heat. [0044] Next, the procedure of a method for arthroscopic ankle arthrodesis will be described with reference to FIGS. 2 to 10 . FIG. 4 is a diagram showing an example of positions where an anterolateral inserting point and an anteromedial inserting point are created, FIG. 5 is a diagram showing a state in which holes are formed in a subchondral bone plate by an ultrasonic treatment tool whose tip has a needle shape, FIG. 6 is a diagram showing a fixed state of the tibia and the talus by a method for ankle arthrodesis according to the present embodiment, FIG. 7 is a diagram showing a conventional fixed state for comparison with FIG. 6 , FIG. 8 is a diagram showing the fixed state of the tibia and the talus fixed by the method for ankle arthrodesis according to the present embodiment, and FIG. 9 is a diagram showing a conventional fixed state for comparison with FIG. 8 . FIG. 10 is a flow chart illustrating surgical steps of the method for ankle arthrodesis. [0045] The method for ankle arthrodesis according to the present embodiment is a method for ankle arthrodesis that forms a fusion surface of bone by successively removing a damaged cartilage and bone on the tibia surface and talus surface in an ankle using an ultrasonic treatment tool and fixing and fusing the tibia and the talus. [0046] Before surgery is started, a leg is first placed on an operating table and a bandage is applied such that, as shown in FIG. 2 , the instep falls to expand the joint fissure to be a space for treatment and the bandage is in traction by a tractor (not illustrated). For the traction, for example, a traction force of about 6 kg is applied for traction (step S 1 ). [0047] Then, an anteromedial inserting point 41 and an anterolateral inserting point 42 (portal) to insert the arthroscope 21 and the ultrasonic treatment tool 2 are formed (step S 2 ). When determining positions thereof, as illustrated in FIG. 4 , a large number of blood vessels/nerves, muscle-tendons and the like are arranged along a tibia 32 , a peroneal bone 33 , and a talus 34 . Here, an anteromedial inserting point that is relatively safe is first created. The anteromedial inserting point 41 is formed in a position between a lower portion 32 a of the tibia on the inner side and the talus 34 and the anterolateral inserting point 42 is formed in a position between the lower portion 32 a of the tibia on the outer side, a lower portion of the peroneal bone 33 , and the talus 34 by avoiding these vascular nerves, muscle-tendons and the like. [0048] Next, as illustrated in FIG. 2 , the ultrasonic treatment tool 2 is inserted from the anteromedial inserting point 41 and the arthroscope 21 is inserted from the anterolateral inserting point 42 (step S 3 ). Incidentally, insertion locations may be interchanged in accordance with the location of the site to be treated. After the insertion, a perfusion made of physiological saline and the like is allowed to flow into the joint from the arthroscope 21 and the perfusion is circulated at a fixed flow rate by using a perfusion apparatus (not illustrated) (step S 4 ). [0049] A cartilage tissue 44 attached to a tibia surface 32 b and a cartilage tissue 45 attached to a talus surface 34 a illustrated in FIG. 6 are all excised by causing an ultrasonic vibration of the treatment section 14 of the probe 12 of the ultrasonic treatment tool 2 (step S 5 ). If any osteophyte is found during cutting, the osteophyte is also excised. If any of the cartilage tissues 44 , 45 and osteophyte remains between joint surfaces of the tibia surface and the talus surface while the joint is fixed by fusion, such a remnant could be an inhibition factor of fusion of the tibia and the talus. [0050] Subsequently, curved surfaces are adjusted by the treatment section 14 provided at the tip of the probe so that curved shapes of the talus and the tibia are in close contact without any gap when the talus and the tibia are matched. That is, each bone is shaved off and shaped such that a concave curved surface of the tibia surface 32 b and a convex curved surface of the talus surface 34 a match by eliminating unevenness of each curved surface using the treatment section 14 vibrated ultrasonically to have curved surfaces of similar curves (step S 6 ). [0051] Next, the ultrasonic treatment tool 2 having the probe 12 including a treatment section 18 with an apical portion having a sharp tip as illustrated in FIG. 5 and bent halfway through the portion is used. Holes of a minimized area are made in 50 to 60 locations using the ultrasonic treatment tool 2 including the treatment section 18 . The treatment section 18 has, as illustrated in FIG. 5 , a bent tip and thus, instead of moving the ultrasonic treatment tool by applying a force in the longitudinal direction of the main body thereof, the ultrasonic treatment tool is moved in a direction perpendicular to the longitudinal direction and therefore, even if the joint fissure is narrow, drilling can easily be performed if only the tip portion of the treatment section 18 is inserted into the joint fissure. [0052] A bone hole is formed in the tibia surface 32 b and/or the talus surface 34 a using the treatment section 18 . The bone hole may be formed in, for example, a dimple shape of a golf ball. The bone hole is made so as to pierce through the subchondral bone plate and the bottom thereof reaches the cancellous bone to allow blood A to bleed onto the bone surface from inside (step S 7 ). Incidentally, the bone hole is not limited to the dimple shape and any shape in which a small amount of blood remains on the surface may be adopted. This is because immobilization is promoted by Bone Marrow Stimulation contained in the bone marrow. The tibia 32 and the talus 34 are matched so that the tibia surface 32 b and the talus surface 34 a are brought into close contact as similar curved surfaces A. [0053] Further, as illustrated in FIGS. 6 and 8 , for example, a plurality of screws are used for screwing to retain a state in which the tibia 32 and the talus 34 are matched (step S 8 ). After the aforementioned traction is removed, as illustrated in FIG. 6 , a plurality of screws is screwed into the ankle under radiographic conditions if necessary. If, as a portion thereof, two or three screws are screwed in obliquely downward so as to intersect, for example, from outside the tibia, the fixing force until bones are fused is improved. [0054] As a concrete procedure, first a guide wire is inserted from the outer surface of the tibia 32 toward the talus 34 in a direction to correct deformation. [0055] Secondly, after the insertion of the guide wire into a body of talus is verified under radiographic conditions, a first screw 43 a is screwed in by over-drilling. [0056] Thirdly, a second screw 43 b is screwed in from inside the tibia 32 into the body of talus. Here, care needs to be taken so that an intersection 51 of two screws is not placed in a high position of the talocrural articulation on both front and rear surfaces and side faces. [0057] Fourthly, if sufficient space is available, a third screw 43 c is screwed in. Then, a wound closure procedure is performed. This is done by suturing only the epidermis using a nylon yarn. At this point, care needs to be taken so that rami of superficial peroneal nerves running hypodermically are not sutured. [0058] The method for ankle arthrodesis as described above is applied to cases in which activities of daily living (called ADL) are hindered due to pain derived from joints observed in degenerative ankle disease and articular rheumatism or deformation (irreversible). In the method for ankle arthrodesis, with an increasing range of motion of neighboring joint groups, the motion of the fixed ankle is compensated for. [0059] Here, as a reference example for comparison with the present embodiment, a conventional representative method for ankle arthrodesis will be described. As illustrated in FIG. 7 , a lower portion 32 c of tibia in a concave shape of the tibia 32 and a lower portion 34 b of talus in a convex shape of the talus 34 are cut along a plane B and these planes are matched and then, as described above, screwed using a plurality of screws 43 . [0060] The conventional method for ankle arthrodesis as described above is easier to perform surgically than the method in the present embodiment, but the tibia 32 and the talus 34 are partially cut relatively deeply and thus, when only one leg is operated on, the leg becomes shorter than the other leg that is not operated on, which makes it difficult for the patient to walk and poses a problem that the patient's upper body is tilted when walking. [0061] Also in the present embodiment, cartilage tissues are excised and bones are formed by using an ultrasonic treatment tool. In contrast, when a conventional treatment tool is used to perform, like the present embodiment, the method for ankle arthrodesis that cuts cartilage tissues and adjusts curved shapes of bone, the procedure therefor is as described below: [0062] First, all cartilage tissues are ablated using a curette or a rasp. Then, the bone is shaved using an ablator and further shaved beyond the subchondral bone plate in, for example, a dimple shape of a golf ball for bleeding. Next, the tibia 32 and the talus 34 are fixed by screwing using a plurality of screws. [0063] If a conventional treatment tool is used for this surgery step, the following problems arise: [0064] If a cartilage the ultrasonic treatment procedure is performed using a curette or a rasp, the treatment surface has a coarse finish. The tibia surface 32 b and the talus surface 34 a have a concave curve surface and a convex curved surface respectively and thus, a joint fissure expanded by traction is narrow and a treatment tool such as a curette and a rasp does not reach the rear side of the talar joint and a sufficient amount of the cartilage cannot be excised. Tissues of the remaining cartilage and the like could become, as described above, an inhibition factor of bone fusion. Further, in a rotating treatment tool such as an ablator and a drill, other tissues (anterior blood vessel/nerves) could be caught and the closest attention needs to be paid. [0065] When a hole is made using a drill, Heat Necrosis may arise in bone due to frictional heat. In contrast, if an ultrasonic treatment tool is used, Heat Necrosis is minimized and bleeding to promote immobilization can be expected. [0066] Further, when a bone hole for bleeding is formed using a drill, power is transmitted linearly and thus, no work can be done on the back side of the joint. [0067] The present embodiment described above performs a cartilage the ultrasonic treatment procedure using an ultrasonic treatment tool and therefore, compared with the past, the following operation/working effects are achieved: Due to micro-vibrations, the ultrasonic treatment tool can finely adjust the amount shaved off at a time by a pressing force of the treatment tool and also due to micro-vibrations, the treatment surface becomes smooth and an effect of promoting immobilization can be expected. Also, by producing the tip portion of the ultrasonic treatment tool thinly or in a thin blade shape, a region unreachable by conventional surgical instruments can be reached from the front portal. The tip portion of the ultrasonic treatment tool does not rotate and therefore, tissues are not caught during treatment. As illustrated in FIG. 6 , the cartilage is excised using an ultrasonic treatment tool and bone boring is performed on, for example, the subchondral bone. Compared with the conventional procedure, drilling using a drill may delay bone fusion due to Heat Necrosis in surrounding tissues. In contrast, if an ultrasonic treatment tool is used, Heat Necrosis and the bone architecture breakdown are minimized so that promotion of bone fusion at an early stage can be expected. In the conventional procedure using an ablator, a driving force acts in the rotation direction due to rotation and therefore, it is difficult to create a smooth surface and the tip needs a certain thickness because of the need of a cover for the prevention of being caught. In the present embodiment, by contrast, a desired shape can be produced because the procedure proceeds in a direction in which a force is applied by devising a curved shape for the tip portion of the ultrasonic treatment tool. When a conventional ablator is used, shaving scum of bone is large and it is difficult to suck, which could also lead to inflammation. In contrast, the ultrasonic treatment tool can finely shave only a surface in contact and therefore, shaving scum can be reduced and it is easy to suck. The treatment sections of probes of the ultrasonic treatment tools illustrated in FIGS. 3A and 3B have a structure that ablates the cartilage also during a push operation, in addition to a pull operation, by providing edges (blades) for treatment forward and backward in a traveling direction of an opening that ablates the cartilage. With this structure, the ultrasonic treatment procedure of 5-time reciprocation is reduced to the ultrasonic treatment procedure of 2-and-half-time reciprocation for the same area. [0073] A conventional current remove only when pulled and also a ultrasonic treatment tool in a conventional structure performs the ultrasonic treatment procedure only in any one direction, but the structure in the present embodiment performs the ultrasonic treatment procedure in both directions of the forward direction and the backward direction so that efficiency can further be improved. In the past, if only the dimple shape is adopted for holes, the diameter increases when the depth is needed and therefore, an adhesive area of the talus and the tibia decreases and the extension of a bone fixing period is assumed. In addition, holes are normally formed in 50 to 60 locations and a lot of time is needed for boring. [0075] In the present embodiment, by contrast, as illustrated in FIG. 5 , an ultrasonic treatment tool whose tip has a needle shape is used for treatment and holes of a small area reaching the subchondral bone plate can be formed. [0076] In the past, a treatment tool for treating the cartilage and a treatment tool for boring a hole are separate and a lot of work is needed, but an ultrasonic treatment tool in the present embodiment can treat both. The ultrasonic treatment tool can be made as thin as possible and so, with its excellent accessibility, can easily treat a site unreachable by an existing treatment tool. Ultrasonic vibrations of infinitesimal amplitude are used for shaving and therefore, the cut surface can be made smooth. Therefore, postoperative conditions are good. Further, ultrasonic vibrations are used for shaving and therefore, cutting is reliable, thermal damage to the site to be treated can be reduced, postoperative conditions are good, and minimal invasiveness is superior. The ultrasonic treatment tool can treat both of soft tissues and hard tissues such as the cartilage and bone and therefore, replacement work of treatment tools can be reduced and burdens on engineers can be reduced. Cutting is achieved by applying the treatment section vibrating ultrasonically and therefore, compared with a treatment section using a drill bit, almost no damage is done even if the treatment tool comes into contact with other sites that are not to be treated. [0081] Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details and representative embodiments shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an edible stable clouding agent to be used in a beverage. More specifically, the invention relates to a stable clouding agent comprised of a water soluble gum, carnauba wax, a polyhydric alcohol of two to six carbons, and an edible salt. 2. Description of the Prior Art Many natural juices, including all freshly expressed citrus juices, have a characteristic turbidity or "cloudiness". It is desirable to maintain this cloudiness when processing natural juices, and to emulate it when perparing formulated beverages. In a natural citrus juice, "cloud" is provided by minute, suspended or colloidal particles of citrus tissue and cell contents. In formulated beverages, however, various "clouding agents" have been utilized to simulate a natural cloud. For example, one known clouding agent is based on brominated oils of specific gravity greater than 1.00 g/ml in combination with lower density flavor oils or vegetable oil, such as citrus oils which have a specific gravity of about 0.85; see U.S. Pat. No. 3,353,961, issued Nov. 21, 1967 to Simon. Such a blend of oils is "balanced" so as to have a density close to that of the beverage in which it is to be suspended. (As an example, sugar sweetened drinks have a preferred specific gravity of about 1.03-1.06 while dietetic drinks have a specific gravity of about 1.0.). By balancing the relatively low density flavor oil, such as citrus oils, with the high density brominated oil, it is possible to inhibit the highly insoluble citrus oils from floating to the top of the particular formulated beverage and from forming a "ring". Instead, the dispersion of the balanced oil in aqueous solutions has a desirable cloudy appearance. However, brominated vegetable oils may now constitute only 15 ppm of a finished formulated beverage. This amount is about 10% of the concentration formerly used to prepare effective clouding agents. Consequently, brominated vegetable oils are now less effective as clouding agents. As a substitute for brominated vegetable oils, the beverage industry generally turned to glyceryl abietate, or "Ester Gum", which is an F.D.A. approved oil-soluble material also of density greater than 1.00 g/ml; see U.S. Pat. No. 3,959,510, issued May 25, 1976 to Felton and Kapp. Although glyceryl abietate, like brominated vegetable oils, can be effectively utilized to prepare an adequate clouding agent, it does have objectional features. Since its specific gravity is 1.08 as compared to approximately 1.30 for brominated vegetable oils, about three times as much Ester Gum is required to achieve the same degree of balancing as is achieved by use of brominated oils. If too much Ester Gum were used, the taste of the finished beverage could possess a bitter character which is often undesirable. Another difficulty arises from the fact that although both glycerol and abietic acid are natural products, Ester Gum is nevertheless produced synthetically from abietic acid, which precludes its use in those beverages which the producer wishes to label as natural. A desirable clouding agent for use in a formulated beverage will avoid the difficulties associated with the aforementioned known clouding agents, as well as possess various other advantages. Specifically, such a clouding agent would be non-toxic, impart little or no taste to the final beverage, and be effective in producing a non-ringing, cloudy beverage. Also important to such a desirable agent would be its ability to produce a final cloudy beverage which is non-ringing for significant periods of time, specifically at least three months. SUMMARY OF THE INVENTION The clouding agent of the present invention is an emulsified composition of finely divided particles of carnauba wax, a water soluble gum, a polyhydric alcohol of two to six carbons, water, and an edible inorganic salt. An edible essential oil distillate such as orange oil distillate and additional resins such as gum elemi may also be incorporated. Important features of the invention include the size distribution of the carnauba wax particles, as well as the weight ratio of wax to alcohol and wax to salt. These features combine to produce the non-ringing stability of the final beverage cloud for periods of at least three months. The wax particle size, as determined by Coulter Counter, is represented herein by specific interfacial area, which is the measured area in square meters of the oil/water interface per cubic centimeter of disperse phase. As the interfacial area increases, the particle size decreases. In general, the wax particle size will range from an interfacial area of 12.5 meter 2 /centimeter 3 to 15.0 m 2 /cm 3 , and preferably from 13.0 to 13.6 m 2 /cm 3 . The weight ratio of wax to salt will generally be from about 1:2 to 2:3 with 2:3 being preferred. The weight ratio of carnauba wax to alcohol will generally be from about 1:4 to 1:3, with 1:4 being preferred. The carnauba wax will comprise about 5.0 to 8.0, preferably about 6.0, percent by weight of the clouding agent. The water-soluble gum usually comprises about 15.0 to 30.0, preferably about 18.0 to 22.0, percent by weight of the emulsified clouding agent. The alcohol typically comprises about 20.0 to 24.0, preferably about 22.0, percent by weight of the emulsion. The salt typically comprises about 8.0 to 12.0, preferably about 9.0, percent by weight of the emulsion. If an essential oil distillate is used, it may comprise up to about 3.0, preferably about 1.0 to 2.0, percent by weight of the emulsion. Also, if a purified gum elemi is used, it may comprise up to about 6.0, preferably up to about 4.0, percent by weight of said emulsion. The water-soluble gum is preferably gum acacia. Other gums and suitable hydrocolloids may also be used. A preferred edible salt is sodium chloride. Another suitable salt is potassium chloride. The polyhydric alcohol should have a chain length of two to six carbons, or alternatively, a molecular weight up to 360. A preferred alcohol is glycerol although other suitable alcohols include propylene glycol and sorbitol. The clouding agent herein disclosed is an emulsion which is prepared by combining the wax with a heated solution of the other ingredients. If optional ingredients such as an essential oil distillate and/or purified gum elemi are used, they are first blended with the carnauba wax. To form such a blend, the wax plus optional oil distillate and/or elemi are combined by heating the mixture to a temperature sufficient to melt the carnauba wax; usually a temperature of about 85° C. will be sufficient. The wax or wax blend is then emulsified with a solution of water, water-soluble gum, alcohol and an edible salt. To perform the emulsification process, the homogeneous solution of water, a water-soluble gum, alcohol, and an edible salt is prepared, then the solution is heated to a temperature sufficient to permit the wax or wax blend to melt when it is stirred into the solution. A temperature of about 95°-100° C. is preferred. The resultant mixture of wax, water, alcohol, gum, and salt is subsequently emulsified by any conventional means capable of producing a final emulsion wherein the particle size of the carnauba wax is characterized by an interfacial area of 12.5 to 15.0 m 2 /cm 3 , preferably 13.0 to 13.6 m 2 /cm 3 . A preferred method of emulsification involves the use of a conventional heat jacketed, 2 stage pressure homogenizer, maintained at a temperature between about 92°-100° C., and a total pressure of 3000 to 7500 psig, preferably 4500 to 6000 psig. The emulsified clouding agent thus obtained is capable of being used in a number of ways well known in the beverage industry art. One example is to prepare a beverage syrup by mixing the clouding agent with a sugar-in-water syrup and other conventional ingredients. Such a beverage syrup may in turn be converted into a final, cloudy beverage by the addition of still or carbonated water. This final, cloudy beverage will be stable against ring formation or settling out for periods of at least three months. DESCRIPTION OF THE PREFERRED EMBODIMENTS The clouding agent of the present invention provides several advantages over known clouding agents. For example, it imparts little or no taste to a final beverage in which it is placed. Moreover, all of the ingredients of the agent are naturally-occurring and non-toxic. The clouding agent of the present invention is intended for use in the preparation of still or carbonated aqueous beverages. A clouding agent prepared in accordance with the present disclosure, comprises in part carnauba wax. It has been found that other edible waxes, e.g. candela and bees wax, do not perform in a manner equivalent to the carnauba wax. Carnauba wax is a natural, non-toxic wax having a specific gravity of about 0.995 and a melting point of about 82°-86° C. Two types of carnauba wax are known--"raw" and "purified." Both function equally well in the invention. The carnauba wax may optionally be blended with certain ingredients known in the art, such as an essential oil distillate, e.g. an orange distillate, and/or natural resins such as purified solid gum elemi, to produce a distillate-wax-resin blend having a density of 0.993 g/ml to 0.987 g/ml. If elemi is added, it is preferred that it be purified first so as to remove any volatile oils which would impart an undesirable taste to the final product. The gum elemi which may be used in the present invention is derived from resins obtained from a tree of the Kanarium family. Although many kinds of elemi resins exist, they are all characterized by the constituent triterpene, amyline (C 30 H 49 OH), which, it is speculated, contributes to emulsion stability. Elemi resins and their purified fractions are non-toxic. The elemi may be purified by resort to any of a number of conventional means such as distillation, extraction, chromatography and precipitation. For example, it may be steam distilled or it may be purified by solubilizing the natural gum elemi with 1.6 parts by weight isopropyl alcohol, isolating the non-soluble portion by filtration, and finally evaporating any alcohol in the filtrate to produce a purified elemi with a density of 1.02 g/ml and a melting point of 130°-142° C. If the carnauba wax is blended with purified elemi and/or an essential oil distillate, it is not necessary to heat the distillate-wax-resin combination beyond about 79°-83° C. in order to effect solution of the elemi and distillate into the Carnauba wax. Upon cooling, such a blend will form a solid having a melting point of about 68°-75° C. This distillate-wax-resin blend or the pure carnauba wax is then converted to a clouding agent emulsion by emulsification with water, a water-soluble gum, preferably a preservative, alcohol and salt. The salt will typically be sodium chloride, however, any edible inorganic salt of alkali or alkaline earth metals and halides, or sulfate may be used in the present invention. The halide salts of the alkali metals are preferred, especially sodium and potassium chlorides. The emulsion is prepared by heating a homogeneous solution of the water, gum, alcohol and salt to a temperature high enough to melt the carnauba wax or wax blend when it is added, preferably between about 95°-100° C. The resultant mixture of wax and water, gum, alcohol and salt is then emulsified by any means sufficient to produce an emulsion in which the particle size of the carnauba wax is characterized by an interfacial area of 12.5 to 15.0 m 2 /cm 3 , preferably 13.0 to 13.6 m 2 /cm 3 . Methods of emulsification known in the art include simple stirring, aeration, propeller agitation, turbine agitation, use of a colloid mill, use of ultrasonics, and homogenization. For a more detailed description of these various emulsification methodologies, see Griffin, "Emulsions", in 8 Kirk-Othmer Encyclopedia of Chemical Technology 900-930 (3d ed. 1979). One good emulsification technique is to employ a shear homogenizer. A preferred method involves the use of a conventional heat jacketed, 2 stage pressure homogenizer maintained at a temperature between about 92°-100° C. (high enough to maintain the wax in its molten state) and a total pressure of 3000 to 7500 psig, preferably 4500 to 6000 psig. Although the exact means by which the clouding agent functions is not known, it does not utilize the aforementioned "balancing" of a relatively low density oil with a heavier oil or gum in order to produce a blend having a density close to that of the beverage in which it is to be suspended. It is believed that the functioning of the clouding agent of the invention involves cooperation of the carnauba wax and salt plus alcohol to form a "micelle-like" structure wherein a microparticle of carnauba wax is suspended in water as a consequence of being surrounded by the salt ions and/or hydrogen bonded alcohol molecules. While true micelles are much smaller than the microparticles of the carnauba wax, the cooperative behavior of the wax particles, salt and alcohol may be similar to that of true micelles. Moreover, it is believed that the salt ions and alcohol produce an electrostatic effect around the wax particles, rather than functioning merely as solution density modifiers. This is because the ability of the clouding agent to avoid ringing decreases rather sharply outside the range of disclosed weight ratios of wax-to-salt and wax-to-alcohol. The clouding agent emulsion so produced may be used in a number of conventional ways. For example, it may be mixed with syrup (either sugar in water or artificial sweetener in water) and other conventional ingredients to prepare a beverage syrup, which beverage syrup may in turn be converted into the final cloudy beverage by addition of still or carbonated water. Suggested concentrations of the clouding agent emulsion in the finished beverage correspond to about 0.05-0.20% by weight of the emulsion, based on the total weight of the final beverage. Such a suggested usage concentration range is only related to anticipated commercial desirability and in no way should be deemed a limitation on the effective concentration of emulsion in an aqueous beverage. It also is possible to dry the clouding agent emulsion by such conventional methods as spray, freeze drum, or Foam-mat drying to form a dry mix having a moisture content no higher than about 5%. Such a dry mix may be optionally mixed with a solid edible acid, dry color, and/or sweetener to form a beverage powder, which may be converted to a final cloudy beverage by the addition of water. The nature of the present invention may be further understood by the following examples of specific embodiments. Unless stated otherwise, all proportions here and elsewhere are in weight percent, based on the weight of the final clouding agent emulsion. EXAMPLE 1 ______________________________________A Carnauba Wax, Sodium Chloride, Glycerol,Gum Acacia Clouding Agent Weight Percent, based on the total weight of the cloudingIngredients agent emulsion.______________________________________Water 40.00Sodium Benzoate 0.20(a preservative)Sodium Chloride 9.00Glycerol 22.80Spray-dried gum acacia 20.00Carnauba wax 6.00Orange oil distillate 2.00______________________________________ The Carnauba wax was melted at a temperature of about 79°-83° C. While the molten wax was kept at a temperature sufficient to maintain it in its molten state, the orange oil distillate was stirred into the molten wax in order to solubilize it. The heat source was subsequently removed to allow the distillate-wax blend to solidify. The blend had a melting point of about 68°-75° C. The final clouding agent emulsion was prepared by adding the water, preservative, salt, glycerol, and gum acacia together and stirring at room temperature to form a homogeneous solution. This solution, while continuously stirred, was heated to a temperature of between about 95° to 100° C. While maintaining this temperature, the distillate-wax blend was stirred into said solution until the blend had melted, thereby forming a cloudifier premix. This premix was then introduced into a conventional heat jacketed 2-stage pressure homogenizer maintained at a temperature of between about 92° to 100° C., so that the cloudifier premix was a liquid during homogenization. The total homogenization pressure was 6000 psi. After homogenization, the cloudifier emulsion was cooled to room temperature. The resultant clouding agent had a specific gravity of about 1.20 at 25° C., as well as an interfacial area of 13.6 m 2 /cm 3 , created a stable long-lasting cloud when utilized as part of an aqueous beverage, and imparted no significant taste. EXAMPLE 2 ______________________________________A Carnauba Wax Clouding Agent Containing Citric Acid Weight Percent, based on the total weight of the cloudingIngredient agent emulsion.______________________________________Water 40.25Sodium Benzoate 0.10Glycerol 20.00Citric Acid 0.13Sodium Chloride 9.00Gum acacia 20.00Carnauba wax 7.89Orange oil Distillate 2.63______________________________________ The Carnauba wax and orange oil distillate were combined in the same fashion as in Example 1. The distillate-wax blend was then combined with the remaining ingredients also as in Example 1 to form a clouding agent having an interfacial area of 12.4 m 2 /cm 3 and showing good stability when used in an aqueous beverage. EXAMPLE 3 ______________________________________A Carnauba Wax Clouding AgentOutside the Invention Weight Percent, based on the total weight of the cloudingIngredient agent emulsion______________________________________Orange oil Distillate 2.63Carnauba wax 7.89Water 44.25Sodium benzoate 0.10Citric Acid 0.13Spray-dried gum acacia 20.00Glycerol 20.00Sodium Chloride 5.00______________________________________ The ingredients were generally combined as in Example 1 to form an emulsion, however the homogenization parameters were adjusted so that the interfacial area of the final emulsion was only 11.4 m 2 /cm 3 , which is outside the scope of the present invention. This clouding agent, when utilized as part of an aqueous beverage, produced a cloud which was not long-lasting, but rather was stable only for about 5 days. Although the invention has been described in terms of specific embodiments set forth in detail, it should be understood that these embodiments are by way of illustration only, and that the invention is not so limited. Modifications and variations will be apparent from this disclosure and may be resorted to without departing from the spirit of this invention, as those skilled in this art will readily understand. Accordingly, such variations and modifications of the disclosed products are considered to be within the purview and scope of this invention and the following claims.

1a

This application is a continuation of U.S. application Ser. No. 09/847,764, filed May 2, 2001, now U.S. Pat. No. 6,569,038. FIELD OF THE INVENTION The present invention relates to golf balls, and more particularly, to a golf ball having improved dimples. BACKGROUND OF THE INVENTION Golf balls generally include a spherical outer surface with a plurality of dimples formed thereon. Conventional dimples are circular depressions that reduce drag and increase lift. These dimples are formed where a dimple wall slopes away from the outer surface of the ball forming the depression. Drag is the air resistance that opposes the golf ball's flight direction. As the ball travels through the air, the air that surrounds the ball has different velocities and thus, different pressures. The air exerts maximum pressure at a stagnation point on the front of the ball. The air then flows around the surface of the ball with an increased velocity and reduced pressure. At some separation point, the air separates from the surface of the ball and generates a large turbulent flow area behind the ball. This flow area, which is called the wake, has low pressure. The difference between the high pressure in front of the ball and the low pressure behind the ball slows the ball down. This is the primary source of drag for golf balls. The dimples on the golf ball cause a thin boundary layer of air adjacent to the ball's outer surface to flow in a turbulent manner. Thus, the thin boundary layer is called a turbulent boundary layer. The turbulence energizes the boundary layer and helps move the separation point further backward, so that the layer stays attached further along the ball's outer surface. As a result, there is a reduction in the area of the wake, an increase in the pressure behind the ball, and a substantial reduction in drag. It is the circumference portion of each dimple, where the dimple wall drops away from the outer surface of the ball, which actually creates the turbulence in the boundary layer. Lift is an upward force on the ball that is created by a difference in pressure between the top of the ball and the bottom of the ball. This difference in pressure is created by a warp in the airflow that results from the ball's backspin. Due to the backspin, the top of the ball moves with the airflow, which delays the air separation point to a location further backward. Conversely, the bottom of the ball moves against the airflow, which moves the separation point forward. This asymmetrical separation creates an arch in the flow pattern that requires the air that flows over the top of the ball to move faster than the air that flows along the bottom of the ball. As a result, the air above the ball is at a lower pressure than the air underneath the ball. This pressure difference results in the overall force, called lift, which is exerted upwardly on the ball. The circumference portion of each dimple is important in optimizing this flow phenomenon, as well. By using dimples to decrease drag and increase lift, almost every golf ball manufacturer has increased their golf ball flight distances. In order to optimize ball performance, it is desirable to have a large number of dimples, hence a large amount of dimple circumference, which are evenly distributed around the ball. In arranging the dimples, an attempt is made to minimize the space between dimples, because such space does not improve aerodynamic performance of the ball. In practical terms, this usually translates into 300 to 500 circular dimples with a conventional-sized dimple having a diameter that ranges from about 0.120 inches to about 0.180 inches. When compared to one conventional-size dimple, theoretically, an increased number of small dimples will create greater aerodynamic performance by increasing total dimple circumference. However, in reality small dimples are not always very effective in decreasing drag and increasing lift. This results at least in part from the susceptibility of small dimples to paint flooding. Paint flooding occurs when the paint coat on the golf ball fills the small dimples, and consequently decreases the aerodynamic effectiveness of the dimples. On the other hand, a smaller number of large dimples also begin to lose effectiveness. This results from the circumference of one large dimple being less than that of a group of smaller dimples. U.S. Pat. No. 4,787,638 teaches the use of grit blasting to create small craters on the undimpled surface of the ball and on the surface of the dimples. Grit blasting is known to create a rough surface. The rough surface on the land surface of the ball may decrease the aesthetic appearance of the ball. Furthermore, these small craters may be covered by paint flooding. U.S. Pat. Nos. 6,059,671, 6,176,793 B1, 5,470,076 and 5,005,838, GB 2,103,939 and WO 00/48687 disclose dimples that have smooth irregular dimple surfaces. These smooth irregular dimple surfaces, however, could not efficiently energize the boundary layer flow over the dimples. One approach for maximizing the aerodynamic performance of golf balls is suggested in U.S. Pat. No. 6,162,136 (“the '136 patent), wherein a preferred solution is to minimize the land surface or undimpled surface of the ball. The '136 patent also discloses that this minimization should be balanced against the durability of the ball. Since as the land surface decreases, the susceptibility of the ball to premature wear and tear by impacts with the golf club increases. Hence, there remains a need in the art for a more aerodynamic and durable golf ball. SUMMARY OF THE INVENTION Accordingly, the present invention is directed to a golf ball with improved dimples. The present invention is also directed to a golf ball with improved aerodynamic characteristics. These and other embodiments of the prevent invention are realized by a golf ball comprising a spherical outer land surface and a plurality of dimples formed thereon. The dimples have a plurality of sub-dimples to energize the airflow over the dimpled surface. The undimpled land surface, therefore, may remain robust to prevent premature wear and tear. The sub-dimples may have a myriad of shapes and sizes and may be distributed in any pattern, concentration or location. The sub-dimples may have a concave configuration, convex configuration or a combination thereof. In another aspect of the invention, the dimples may have radiating arms emanating from the center of the dimple or a location proximate the center, or from a hub. Preferably, the radiating arms are evenly distributed throughout the dimple. The radiating arms may have a plurality of shapes. At least some of the radiating arms may selectively protrude into the land surface or undimpled surface of the ball to improve the airflow over the land surface of the ball. BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawings which form a part of the specification and are to be read in conjunction therewith and in which like reference numerals are used to indicate like parts in the various views: FIG. 1 is a front view of a preferred embodiment of a golf ball in accordance to the present invention; FIGS. 2 a - 2 i are top views of the sub-dimple embodiments in accordance to the present invention; FIG. 3 is a front view of another preferred embodiment of the golf ball in accordance to the present invention; FIGS. 3 a - 3 e are top views of the radiating arm dimple embodiments of the present invention; FIGS. 4 a - 4 c are top views of the enlarging radiating arm embodiments of the present invention; FIGS. 5 a - 5 b are top views of alternating concave/convex arm embodiments of the present invention; FIG. 6 is a front view of another preferred embodiment of the golf ball in accordance to the present invention; FIGS. 6 a - 6 b are top views of protruding arm embodiments of the present invention; and FIGS. 7 a - 7 d are top views of non-circular dimple embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION As shown generally in FIG. 1, where like numbers designate like parts, reference number 10 broadly designates a golf ball 10 having a plurality of dimples 12 separated by outer undimpled or land surface 14 . In accordance to one aspect of the present invention, dimples 12 may have sub-dimples defined on thereon to further agitate or energize the turbulent flow over the dimples and to reduce the tendency for separation of the turbulent boundary layer around the golf ball in flight. As described below, the sub-dimples may have many shapes and sizes, as long as they contribute to the agitation of the air flowing over the dimples. FIGS. 2 a - 2 i illustrate sub-dimples 16 disposed on the land surface 17 of the dimple 12 . As used herein, the land surface 17 of the dimple 12 is the concave surface of the dimple unaffected by the sub-dimples or other sub-structures defined on the dimple. For spherical dimples, the land surface 17 is spherical or arcuate. The land surface may also be flat or may have any irregular shape known in the art. As taught in the '136 patent, the circumference of the dimples optimizes the aerodynamic performance of the golf ball. Similarly, the perimeter of the sub-dimples 16 also contributes to and improves the aerodynamic of the golf ball. Preferably, the size and depth of the sub-dimples are sufficiently large to minimize paint flooding. As shown in FIG. 2 a , the distribution of the sub-dimples 16 may be random, and the size of the sub-dimples, may also vary. Advantageously, the sub-dimples of the present invention remedy a design issue known in the art, i.e., minimizing the land surface 14 of the golf ball for better aerodynamics but without increasing the wear and tear on the ball during repeated impacts by the golf clubs. In accordance to the present invention, the aerodynamic performance is increased by increasing the agitation of the boundary layer over the dimpled surfaces, and the land surface 14 may remain robust to resist premature wear and tear. The sub-dimples 16 can assume a regular pattern, such as a triangular pattern shown in FIG. 2 b . They may concentrate near the bottom of the dimple, as shown in FIG. 2 c , or near the perimeter of the dimple, as shown in FIG. 2 d . The sub-dimples may also abut or overlap each other. As shown in FIG. 2 e , dimple 12 has cluster 18 , which comprises four abutting sub-dimples 16 . An advantage of the abutting distribution is that it may produce sharp angles 20 . Sharp angles or other acute shapes are known to delay flow separation over an object in flight. The angles or shapes may be altered by repositioning one or more of the sub-dimples so that they overlap. Cluster 18 may be positioned at the bottom center of the dimple 12 , as shown in FIG. 2 e , or be disposed proximate to the perimeter of dimple 12 . Additionally, dimple 12 may have more than one cluster 18 , and cluster 18 may comprise any number of overlapping sub-dimples. In accordance to another aspect of the invention shown in FIG. 2 f , the sharp angle feature can be accomplished by polygonal sub-dimples 22 having a plurality of relatively sharp angles 24 . FIG. 2 f illustrates regular hexagonal sub-dimples 22 . Other suitable polygonal shapes are shown in FIG. 2 g . The sub-dimples in one dimple 12 may comprise polygonal sub-dimples 22 , as well as circular sub-dimples 16 in any combination thereof, as illustrated in FIGS. 2 g - 2 i. When dimple 12 has a depth of about 0.010 inches from the land surface 14 , a concave sub-dimple 16 , 22 preferably has a depth from 0.0101 to 0.020 inches from the land surface 14 of ball 12 . The sub-dimples may also be convex, i.e., protruding or upstanding from the land surface 17 of the dimple 12 . A convex sub-dimple may protrude from 0.0001-0.010 inches from the arcuate land surface 17 of dimple 12 . The sub-dimples may either be all concave or all convex, or be a mixture of concave and convex shapes. Preferably, most of the sub-dimples are concave. The sub-dimples can be arranged in any pattern, such as the ones shown in FIGS. 2 a - 2 i , or in any pattern of golf ball dimples known in the prior art. In other words, the relatively small sub-dimples can be arranged within one dimple in any pattern similar to the patterns in which the relatively larger dimples are arranged on a golf ball. In accordance to another aspect of the invention shown in FIG. 3, the airflow across golf ball 10 can be energized and agitated by arms emanating from a location proximate to the center of the dimple. As shown FIG. 3 a , dimple 12 comprises a plurality of radiating arms 24 . Five arms are shown in FIG. 3 a . However, any number of arms can be distributed within a single dimple as illustrated in FIG. 3 b . Arms 24 may have a concave profile, i.e., the arms are carved from and are situated below the land surface 17 of dimple 12 . For concave radiating arms, the perimeters 26 of the arms 24 energize the airflow over the dimples. Arms 24 may also have a convex profile, i.e., the arms are upstanding from land surface 17 of dimple 12 , and are situated above the land surface 17 . For convex radiating arms, the raised outer surfaces 28 of arms 24 energize the airflow over the dimples. Alternatively, radiating arms 24 may emanate from a hub 30 , as shown in FIG. 3 c . Hub 30 may be protruding from the land surface 17 or may be a depression below land surface 17 . Hub 30 may have a round profile, as shown in FIG. 3 c or a polygonal profile, as shown in FIG. 3 d . Advantageously, hub 30 also contributes to the agitation of the airflow over the dimples, either by its raised profile if it is convex, or by its perimeter if it is concave. If hub 30 has a concave shape, then it is structurally similar to a sub-dimple discussed above. Alternatively, while FIGS. 3 a - 3 d show blade-shaped arms, radiating arms 25 shown in FIG. 3 e may have substantially straight sides 32 . The radiating arms may also be enlarging in the radial direction. FIGS. 4 a and 4 b illustrate two examples of the enlarging radiating arm embodiment. Dimple 12 has a plurality of enlarging arms 34 radiating from the center or at a location proximate to the center of dimple 12 . As arms 34 approach the perimeter of the dimple, their width gradually increases. Each arm is separated from one another by perimeter lines 36 . As shown in FIG. 4 a , perimeter lines 36 are curved, and as shown in FIG. 4 b perimeter lines 36 are wavy. Alternatively, the perimeter lines can be straight, or they can be straight and extending in the radial direction. In the embodiment shown in FIGS. 4 a and 4 b , the arms 34 can either be convex or concave or a combination thereof. Advantageously, the dimple land area 17 has been eliminated in this embodiment so that the entire dimple surface is dedicated to energizing the airflow over the dimples. Similar to the previous embodiments, if the arms are concave the perimeter lines 36 would agitate the airflow over the dimples, and if the arms are convex, then the protruding surfaces 38 would agitate the airflow. Arms 34 may also radiating from hub 30 . FIG. 4 c shows a variation of the radiating arms. Radiating arms 40 have substantially a diamond shape. Generally, arms 40 are initially enlarged radially from the center of the dimple, and after reaching a predetermined maximum width the perimeter lines 42 approach each other and intersect at a location proximate to the lip of the dimple. The perimeter lines 42 can be substantially straight, as shown, or these lines may assume any non-linear configuration. In this particular embodiment, the land surface 17 of dimple 12 is limited to the outer periphery of the dimple. FIG. 5 a is another embodiment of dimple 12 that combines elements from the previous embodiments. This dimple has a plurality of blade-shaped arms 24 and diamond shape arms 40 radiating from the center or a location proximate to the center of the dimple. Hub 30 may also be used. Optionally, the end points of blade shape aims 24 define a polygon (shown in phantom), and arms 40 do not extend beyond the perimeter of the polygon. In this embodiment, arms 24 may be concave while arms 40 are convex. Alternatively, arms 24 , 40 can be either all concave or all convex or may have any combination of convex or concave shape. FIG. 5 b is a variation of the embodiment of FIG. 5 a . Here, non-circular dimple 44 comprises a plurality of substantially straight arms 25 emanating from an optional hub 30 . Disposed between adjacent straight arms 25 is a polygonal, e.g., triangular, enlarging arm 46 . Preferably, straight arms 25 may be concave and enlarging arms 44 may be convex. Alternatively, arms 25 , 46 are either all convex or all concave, or may have any combination of convex or concave shape. Non-circular dimple 44 may optionally be enclosed within a circular dimple (shown in phantom), and the area between the perimeter of the circular dimple and the enclosed polygonal dimple 44 is preferably not affected by the radiating arms 25 , 46 . In other words, this area is similar to the land area 17 of dimple 12 previously described above. FIGS. 6, 6 a , and 6 b illustrate another aspect of the present invention. FIG. 6 a shows a dimple 50 , which has a plurality of arms 52 emanating from the center of the dimple or a location proximate the center. Arms 52 are similar in shape to blade shaped arms 24 described above, except that arms 52 protrude beyond the perimeter of dimple 50 . Preferably, arms 52 have a concave configuration so that the perimeters 54 of the arms energize the airflow over the dimples. Advantageously, protruding portions 56 of arms 52 can additionally energize the airflow over the undimpled land surface 14 of the ball 10 . The agitation of the airflow by the undimpled land surface 14 increases the aerodynamic performance of the golf ball. FIG. 6 b discloses another variation of dimple 50 where only some of the arms 52 have protruding portions 56 , while the other arms 52 are truncated at the perimeter of the dimple. Preferably, the truncated arms alternate with the untruncated arms, as illustrated in FIG. 6 b . Arms 52 may also radiate from a central hub 30 . FIG. 6 illustrates a golf ball 10 with multiple dimples 50 shown in FIG. 6 b disposed thereon. FIGS. 7 a - 7 d illustrate some of the non-circular dimple embodiments in accordance to the present invention. FIGS. 7 a and 7 b show two polygonal dimple embodiments: pentagonal dimple 58 and hexagonal dimple 60 , with arms 24 emanating from the center, from a location proximate to the center of the dimple, or from hub 30 . Again, arm 24 can be either convex or concave, as described above. Advantageously, protruding arms 52 with protruding portion 56 can also be used in place of one or more arms 24 in the non-circular dimple embodiments. FIG. 7 c is an example of a polygonal dimple 52 , specifically a pentagonal dimple, with emanating substantially straight arms 25 disposed therein. FIG. 7 d is an example of a non-circular dimple 64 with a plurality of arms emanating from the center of a location proximate the center. As shown, due to the irregularity of the perimeter of the dimple 64 , some of the arms 24 may be truncated. Furthermore, protruding arms 52 may be used in place of one or more arms 24 in this embodiment. The use of sub-dimples 16 , 22 or radiating arms 24 , 25 , 34 , 40 , 52 , etc. in accordance to the present invention advantageously render golf balls with lower percentage of dimple coverage more aerodynamically desirable. More preferably, the sub-dimples are suitable for use with golf balls having greater than 60% or most preferably greater than 70% of dimple coverage. The dimpled golf ball in accordance to the present invention can be manufactured by injection molding, stamping, multi-axis machining, electrodischarge machining (“EDM”) process, chemical etching and hobbing, among others. While various descriptions of the present invention are described above, it is understood that the various features of the embodiments of the present invention shown herein can be used singly or in combination thereof. For example, the sub-dimples 16 , 22 can be used in combination with the radiating arms 24 , 25 , 34 , 40 , 52 within a single dimple. This invention is also not to be limited to the specifically preferred embodiments depicted therein.

1a

BACKGROUND OF THE INVENTION A. Field of the Invention The present invention relates to accessories for use by players engaging in the sport of hockey. More particularly, the invention relates to a protector accessory which fits over the skate of a hockey player to minimize injuries to the foot and ankle of the player. B. Description of Background Art Ice hockey has long been a popular group sport for young people to participate in. It is also a very popular spectator sport in which fans can watch their favorite grade school, high school, college or professional hockey teams engage competing teams. Probably one of the main reasons that people enjoy watching or playing hockey games is the speed at which play occurs. Players accelerate quickly on the ice, and skate between goals at opposite ends of an ice rink at speeds up to 15 miles per hour. A pair of goal nets is positioned at opposite long ends of the ice rink. Goal points are scored by launching a disk-shaped puck made of a very hard rubber into an opponent's net which is guarded by a goalie stationed at the net. The puck is launched by striking it with an L-shaped stick, to thus propel it along the ice or through the air into the goal net. Originally, hockey sticks were made of a tough hard wood such as ash. Using traditional hard wood sticks, a puck could be accelerated to speeds of about 35 to 45 mph. Thus, it can be easily understood that a hard rubber puck, weighing about 8-10 ounces and traveling at 40 mph. can cause painful injuries if it impacts a player. Since a puck is launched from the surface of an ice rink, the puck generally travels along the surface of the ice or at relatively low elevations above the surface of the ice. Therefore, the most common impact areas of a player who inadvertently gets in the way of a speeding puck are the player's skates, feet and ankles. Modernly, wooden hockey sticks have been replaced with sticks made of aluminum, fiberglass, or synthetic composite materials. The newer hockey sticks are more durable than the older wooden sticks, and have the advantage of enabling pucks to be launched at much higher speeds. Modern hockey sticks made of such materials are capable of accelerating pucks to speeds as great as twice that attainable with the older wooden sticks, e.g., 70 mph. as opposed to 35 mph. Since the kinetic energy of a moving object is proportional to the square of its velocity, pucks launched with the newer sticks can have kinetic energies of the order of four times that of pucks launched using a wooden hockey stick. Accordingly, the potential for receiving painful and potentially serious injuries from a flying puck in modern hockey games if quite substantial. The potential for painful if not serious injuries to the feet and ankles exists for all hockey players, and particularly so if they are participants in games in which the newer aluminum or composite sticks are used. The problem of potential injuries exists for both professional hockey players, and members of amateur grade school, high school and college teams. Also, because of the increasing popularity of hockey, there are increasing numbers of amateur hockey players who are not necessarily affiliated with a school or college. Accordingly, there is an increasing need for providing some means of protecting the ankles and feet of hockey players from injuries caused by pucks flying at higher speeds. One solution to the problem of protecting the ankles and feet of a hockey player from impact injuries caused by flying hockey pucks is to use the obvious expedient of positioning some sort of padding medium over likely and vulnerable impact regions of the feet and ankles. Thus, there have been proposed various sorts of cushioning or padding accessories which are incorporated into the instep and/or ankle side regions of hockey skates, or as parts of straps which may be attached over skates on a player's feet. However, such protective articles have not been widely adopted, for a number of reasons. One problem with prior art protectors for hockey players' feet and ankles is that some such devices are custom made of expensive materials such as carbon fibers, and, at a cost of several hundred dollars per skate, effectively place such articles beyond the practical reach of most amateur players. Simpler and cheaper feet protector devices for hockey players have been proposed which utilize an elastomeric insert, or a flowable gel to absorb impact energy of a flying puck. However, these devices have proved ineffective because they generally transmit the full impact shock of a flying puck to parts of the ankle or foot. The limitations of prior art ankle and foot protectors for hockey players discussed above was a primary motivation for the present invention. OBJECTS OF THE INVENTION An object of the present invention is to provide an impact force attenuating accessory which fits over the instep and ankle regions of a skate worn by a hockey player to thereby reduce the magnitude of impact forces exerted by a flying hockey puck on the ankle and foot of a hockey player. Another object of the invention is to provide an impact force attenuating accessory for hockey players which fits over the skate and includes a vertically disposed front instep protector pad, and two angularly upwardly and rearwardly disposed ankle side protector pads which extend laterally outwardly and upwardly from opposite vertical sides of the instep pad. Another object of the invention is to provide an impact force attenuating accessory for hockey players which includes a front vertically disposed instep protector pad and a pair of left and right ankle side protector pads that protrude laterally outwards from left and right vertical sides of the instep protector pad, each ankle side protector pad having a pocket which holds therein a force attenuating shield consisting of a convex meniscus-shaped insert shell which is made of an elastically deformable polymer material. Another object of the invention is to provide an impact force attenuating accessory which is removably attachable to a hockey skate and includes a front vertically disposed instep protector pad and left and right ankle side protector pads that protrude laterally outwards from left and right vertical sides of the instep protector pad, each ankle side protector pad having a pocket containing an outwardly convex meniscus-shaped insert made of an elastically deformable polymer, such as high density polyethylene (HDPE), outer lateral sides of the ankle side protector having protruding laterally outwards therefrom a strap and buckle, respectively, for securing the side ankle protectors in position over the ankle sides of a player's skate. 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 an impact force attenuating energy dissipating ankle and foot protector accessory which is removably attachable over an ice skate worn by a hockey player, and which protects the ankle and foot of a player from painful and potentially serious injuries which can be caused by a flying hockey puck impacting the feet and ankles of a player. According to the invention, a pair of identical accessories is provided, each of which is interchangeably attachable over the left or right skate of a hockey player. Each impact force attenuating energy dissipating ankle and foot protector accessory for hockey players according to the present invention includes a front, flexible vertically elongated rectangular instep protector pad which is positionable over the instep or front lace area of a hockey skate. Preferably, outer corners of left and right upper and lower edges of the instep protector pad have convex, arcuately curved edges, thus giving the instep protector pad in plan view the shape of a vertically oriented race track. The instep protector pad of the ankle and foot protector accessory according to the present invention preferably is made of a durable, flexible fabric such as ballistic nylon which has inner and outer laminations that have formed therebetween adjacent laterally elongated, rectangularly-shaped pockets. In an example embodiment, the instep protector pad has a lower rectangularly-shaped pocket which has a lower sewn edge located a short distance above the lower eyelets, two intermediate pockets of approximately the same size and shape as the lower pocket located above and spaced apart from the lower pocket, and an upper pocket located above the upper lateral edge of the upper one of the two intermediate pockets. Each pocket contains therein an impact force attenuating shield consisting of a thin, generally rectangularly-shaped strip of a hard, elastically deformable material such as high density polyethylene (HDPE) which is effective in attenuating the impact force of a hockey puck. Optionally, the hard force attenuating strips may be backed by resilient or gel-filled pads. The arrangement of vertically spaced apart pockets each containing a separate hard insert enables the instep protector pad to be bendable into a rearwardly facing arcuately curved convex shape which is conformable to the concave front lacing area of an ice skate which overlies the instep area of a skater's foot. In a preferred embodiment of a protective accessory according to the present invention, the instep protector pad has located a short distance above a lower transversely disposed horizontal edge of the pad a pair of horizontally aligned eyelets which are laterally spaced apart from a longitudinal center line of the pad. The eyelets are provided to receive therethrough the bottom horizontally disposed segment of a skate's attaching lace, thus securing the bottom edge of the instep protector pad in position over the lower front portion of the skate's lacing area and the instep of a skater wearing the skate. Each impact force attenuating, energy absorbing ankle and foot protector accessory also includes a pair of left and right ankle side protector pads which protrude laterally outwards from left and right vertical sides of the front vertically disposed instep protector pad. Each ankle protector pad is flexibly bendable rearward from the instep protector pad, and secureable in place to overlie outer and inner ankle sides of a skater by a strap and buckle which protrude outwardly from outer edges of the ankle protector pads. Each ankle protector pad of each ankle and foot protector accessory has a pocket in which is contained a force attenuating shield consisting of an outwardly, convex, circular meniscus-shaped insert shell which is made of relatively hard, elastically deformable material such as high density polyethylene (HDPE). The meniscus-shaped HDPE insert shell is reversibly deformable into a concave shape upon being impacted by a flying hockey puck. This deformation is highly effective in absorbing energy from a flying puck, and substantially attenuating impact forces on a skater's ankles. Optionally, the concave rear surface of each meniscus-shaped hard insert may be backed by a resilient or gel-filled pad. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front elevation view of an impact energy dissipating ankle and foot protector accessory for hockey players according to the present invention. FIG. 2 is a rear elevation view of the accessory of FIG. 1 . FIG. 3 is a left side perspective view of the accessory of FIG. 1 , showing ankle protector pads of the accessory flexed rearwards. FIG. 4 is a right side perspective view of the accessory of FIG. 3 . FIG. 5 is an upper rear view of the accessory of FIG. 1 , showing ankle protector pads of the accessory flexed rearwardly from the instep protector part of the accessory. FIG. 6 is a lower rear view of the accessory of FIG. 5 . FIG. 7 is a partly broke-away front perspective view of the accessory of FIG. 1 , showing both meniscus-shaped insert shells and flat energy absorbing insert strips thereof. FIG. 8 is a medial longitudinal sectional view of the meniscus insert shell of FIG. 7 , showing in phantom a optional resilient or gel filled backing pad. FIG. 9 is a front perspective view of the accessory of FIG. 1 located in a position preparatory to attaching the accessory to an ice skate. FIG. 10 is a view similar to that of FIG. 9 , showing the accessory attached to an ice skate. FIG. 11 is a vertical longitudinal sectional view of the accessory of FIG. 9 , showing the relation of a skaters angle side relative to a convex energy dissipation meniscus insert shell of the accessory. FIG. 12 is a view similar to that of FIG. 11 , but showing a convex energy dissipating meniscus insert shell thereof elastically and reversibly deformed to a concave shape in response to an impact force exerted by a flying puck. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1-12 illustrate the construction and function of an impact force attenuating energy dissipating ankle and foot protector accessory for hockey players, according to the present invention. The accessory may be removably attached to either the left or right skate worn by a hockey player. Preferably two of the accessories would be used, one for the left skate and one for the right skate. Referring to FIGS. 1-6 , it may be seen that an impact force attenuating energy dissipating ankle and foot protector accessory 20 for hockey players includes a front vertically disposed instep protector pad 21 , and left and right ankle protector pads 22 , 23 , respectively, which extend laterally outwards from opposite vertical sides 24 , 25 of the instep protector pad. Preferably, as shown in FIGS. 1 and 6 , the left and right protector pads 22 , 23 are laterally outwardly located parts of a unitary ankle protector component 26 . As shown in FIG. 6 , ankle protector component 26 has a central generally rectangularly-shaped section 27 which has a flat front surface 28 that is affixed to a flat rear surface 29 of the instep protector pad 21 . As may be seen best by referring to FIG. 7 , both instep protector pad 21 and left and right ankle protector pads 22 , 23 of ankle protector component 26 have a laminated construction. Thus, as shown in FIG. 7 , front instep protector pad 21 includes a front lamination 30 , and a congruently-shaped rear lamination 31 . The front and rear laminations are joined together near the outer peripheral edges thereof by sewn stitching, forming between the front and rear laminations a space 33 having a plan-view shape similar to those of the front and rear laminations. Front and rear laminations 30 and 31 of instep protector pad 21 are preferably made of a tough, flexible fabric such as ballistic nylon. In an example embodiment of protector 20 , the front and rear laminations 30 , 31 were both made of: 1680 denier, Approx. 320 threads per inch 12 ounces/square yard 3M brand ballistic nylon, purchased from Glen Raven Inc., 1831 North Park Avenue, Glen Raven, N.C. 27217-1100, USA. As shown in FIG. 7 , space 33 between inner facing surfaces of front and rear laminations 30 , 31 of instep protector pad 21 has the shape of a vertically elongated rectangle. Preferably, as shown in FIG. 1 , each of the four corners of instep protector pad 21 have convex, arcuately curved, i.e., radiused edges, thus giving it the shape of a vertically oriented race track. In a preferred embodiment, the rectangular space 33 within instep protector pad 21 is partitioned into a vertical sequence of parallel laterally elongated rectangularly-shaped pockets 34 - 1 , 34 - 2 , 34 - 3 and 34 - 4 . The first or lowest pocket 34 - 1 has a lower horizontally disposed closed edge 35 - 1 which is preferably formed by a horizontally disposed line sewn threaded stitching line. Lowest pocket 34 - 1 also has an upper horizontally disposed edge 35 - 2 which serves as the lower edge for the second pocket 34 - 2 . Similarly, second pocket 34 - 2 has an upper edge 35 - 3 which is co-extensive with the lower edge of third pocket 34 - 3 , third pocket 34 - 3 and has an upper edge 35 - 4 which is co-extensive with the lower edge of fourth, uppermost pocket 34 - 4 , which has an upper sewn edge 35 - 5 . As shown in FIG. 7 , pockets 34 have a common vertically disposed left edge which also is a sewn joint 36 -L. Referring still to FIG. 7 , it may be seen that each pocket 34 of instep protector pad 21 contains an impact absorbing protective insert strip 37 . Each protective insert strip 37 consists of thin, laterally elongated, rectangular strip which is made of a tough, flexible material such as high density polyethylene (HDPE). In an example embodiment, each insert strip 37 was made of an inch thick strip of Prime HDPE 250, obtained from Primex Plastics Corporation, 65 River Drive, Garfield, N.J. 07026 USA. As shown in FIG. 7 , some or all of the pockets 34 of instep protector 21 may optionally include an additional insert 38 located between the rear surface of an insert 37 and the front, inner facing surface 30 L of rear lamination sheet 31 . Insert 38 is made of a resilient material such as Prime HDPE 250 or a capsule filled with a gel such as 150 Gel, Stock # 19661, obtained from Impact Gel Equine, 1540 Heritage Blvd., Suite 201A, West Salem, Wis. 54669 As shown in FIG. 1 , the right vertical edges of pockets 34 are closed by a common vertically disposed sewn joint 36 -R. As is also shown in FIGS. 1 and 7 , instep protector 21 preferably has a pair of horizontally aligned grommets or eyelets 40 L, 41 R which are spaced equidistant from opposite sides of a vertical center line and are located a short distance above the lower edge of the instep protector pad 21 . Referring now to FIGS. 2 and 7 , ankle protector component 26 of ankle and foot protector accessory 20 includes a front lamination 42 and a congruent rear lamination 43 which are joined together near outer peripheral edges thereof, preferably by a peripheral stitched joint 44 which is parallel to and located a short distance inwards of the outer peripheral edges of the laminations, forming between the front and rear laminations a space 44 . As shown in FIG. 2 , left and right ankle protector pads 22 , 23 have an identical shape. Each pad 22 , 23 has a straight vertical inner edge 45 L, 45 R which joins left and right outer edges 46 L, 45 R of rectangular central section 27 of ankle protector component 26 . As shown in FIG. 2 , a lower end of rectangular central section 27 of ankle protector component 26 is joined to the rear surface 47 of insert protector pad 21 by a horizontally disposed sewn stitched joint 48 which is located a short distance above and parallel to the lower edge 49 of the central section 27 . Preferably lower stitched joint 48 of ankle protector pad central section 27 is coextensive with the upper stitched joint 35 - 2 of lowest insert pocket 34 - 1 of instep protector pad 21 . Referring still to FIG. 2 , it may be seen that rectangular central section 27 of ankle protector component 26 is joined to rear surface 47 of instep protector pad 21 by a second horizontal stitched joint 50 , which is located above and parallel to first, lower stitched joint 48 . Preferably, stitched joint 50 is coextensive with the upper stitched joint 35 - 3 of second insert pocket 34 - 1 of instep protector pad 21 . This second joint 50 is located at a distance of about one-third the height of the rectangular central section 27 of ankle protector pad component 26 . Thus located, second, upper ankle protector joint 50 serves as a horizontally disposed self-hinge line which enables the upper part of the central section 27 to be flexed rearwardly from the instep protector pad 21 , as shown in FIG. 5 . Referring to FIG. 2 , it may be seen that left and right ankle protector pads 22 , 23 of ankle and foot protector accessory 20 have lower generally straight edges 51 L, 51 R which extend obliquely outwards and upwards from the bottom edge 52 of central section 27 of ankle protector component 26 . Outer ends of obliquely upwardly and outwardly angled edges 51 L, 51 R are tangent to generally semi-circularly-shaped left and right pad sections 53 L, 53 R of left and right protector pads 22 , 23 , respectively. Semi-circular pad sections 53 L, 53 R in turn have upper arcuately curved, convex edges 54 L, 54 R which extend inwardly towards central rectangular section 27 of ankle protector component 26 , and arcuately join the arcuately curved concave upper edge 55 of the central rectangular section. As may be best understood by referring to FIGS. 1 , 2 and 7 , the laminated construction of ankle protector component 26 of protector accessory 21 forms between the common front and rear laminations 42 , 43 of left and right ankle protector pads 22 , 23 , left and right generally circular plan-view pockets 55 L, 55 R. As shown in FIG. 7 , each pocket 55 L, 55 R holds therein a force attenuating insert 56 L, 56 R. As shown in FIG. 8 , each force attenuating insert 56 has the shape of a section of a thin spherical shell which has a convex outer surface 57 and concave inner surface 58 which is concentric with and generally parallel to the outer convex surface, thus giving the insert the shape of a meniscus. Insert shell 56 is made of a hard, elastically deformable material such as a synthetic polymer. In an example embodiment of accessary 20 , each shell 56 was made of Prime HDPE 250 which had a density of 0.950 grams/cc, an outer radius of curvature of 3.2807 inches, an inner radius of curvature of 3.2207 inches, a thickness of 0.060 inch, and a base diameter of 3.25 inches. As shown in FIGS. 1 and 2 , ankle protector component 26 of ankle and foot protector accessory 20 preferably has a pair of horizontally aligned grommets or eyelets 60 L, 60 R which penetrate left ankle protector pad 22 and right ankle protector pad 23 , respectively. Grommets 60 L, 60 R are located laterally outwards of left and right outer vertical side edges 46 L, 46 R of instep protector pad 21 , a short distance above lower obliquely upward angled edges 51 L, 51 R of left and right protector pads 22 , 23 . As is also shown in FIGS. 1 and 2 , each ankle and foot protector accessory 20 has a flexible strap 61 which extends outwardly from an outer vertical edge of an ankle protector pads, such as right ankle protector pad 23 , and a buckle 62 for releasably securing an end of strap 61 , the buckle protruding from an outer vertical edge of the other ankle protector pad, such as left ankle protector pad 22 . As shown in FIG. 1 , strap 61 preferably has an inner longitudinally disposed half 61 L which has on a front surface thereof a loop-pile fabric strip of a hook-and-loop fastener, and an outer longitudinally disposed half which has a hook-type fastener strip 61 H. With this arrangement, strap 61 may be secured to buckle 62 by inserting outer end 61 H through the eye of the buckle, looping outer hook-end 61 H back towards inner loop-end 61 L, and pressing parts 61 H and 61 L together. FIGS. 9 and 10 illustrate how ankle and foot protector accessory 20 is releasably fastened to an ice skate worn by a skater. First, as shown in FIG. 9 , accessory 20 is positioned in front of a skate placed on a skater's foot, with instep protector pad 21 aligned with the front lacing area of the skate that overlies the instep region of the skater's foot. As shown in FIGS. 3-6 , the flexible construction of instep protector pad 21 facilitates flexibly bending the pad into a rearwardly convex contour which is conformable to the front concave contour of the instep/lace part of a skate. As is also shown in FIGS. 3-6 , the flexible self-hinge regions between ankle protector pads 22 , 23 and left and right edges of central section 27 of ankle protector component 26 , enable the ankle protector pads to be flexed rearwardly over the outer and inner ankle regions of the skate, as shown in FIG. 10 . Next, instep protector pad 21 of accessory 20 is fitted conformally over the front lacing area of a skate S, and a lace L is threaded through a first lower eyelet of the skate, through eyelets 41 L, 41 R of the instep protector pad and through a second lower skate eyelet. The lace is then threaded through upper eyelets of the skate in a customary fashion. Optionally, as the lace is threaded through progressively higher eyelet pairs of skate S, the lace may be threaded through eyelets 60 L, 60 R of left and right ankle protector pads 22 , 23 and over instep protector pad 21 , to further secure accessory 20 to skate S. Finally, as shown in FIG. 10 , strap 61 of accessory 20 is flexed around the rear ankle portion of skate S, inserted through buckle 62 , and cinched tightly, whereupon hook portion 61 H of the strap pis pressed into loop portion 61 L of the strap to secure it in place on the skate and foot of a skater. FIGS. 11 and 12 illustrate the function of meniscus-shaped force attenuating shell inserts 56 L, 56 R of left and right ankle protector pads 22 , 23 . As shown in those figures, when a hockey puck P strikes a skate with sufficient force, the outer surface of an ankle protector, such as left ankle protector pad 22 , the outer convex surface 57 of insert shell 56 deforms temporality and elastically to a concave contour, while concave inner surface 58 of the shell deforms to a convex shape. This deformation has been found to greatly reduce the magnitude of an impulsive force which would otherwise be transmitted through the skate to the ankle A of a foot F. The force attenuation is believed to be the result of absorption of a substantial amount of energy from the impacting puck, the energy being required for deforming shell 56 . When the impulsive force exerted on ankle protector pad 22 by puck P terminates, as the puck rebounds from the ankle protector pad after impacting it, shell 56 reversibly reforms to its original outwardly convex shape, thus dissipating deformation energy in an outer direction. FIG. 8 illustrates an optional gel-filled backing pad 70 which may be located in an ankle protector pocket 55 . As shown in FIG. 8 , gel-filled backing pad 70 preferably has the shape of a spheroidal section which fits conformally into the concave rear interior space of meniscus-shaped shell 56 .

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to devices for physical therapy, conditioning or training, and in particular to inflatable devices. 2. Description of Related Art Many devices are known for facilitating exercises done for therapy, conditioning or physical training. Other than variable resistance training equipment, these devices have not usually offered much adjustability to allow for exercises at different degrees of difficulty. Also, many of these devices have been dedicated to very specific exercises and therefore do not justify a significant investment of space and financial resources for such a narrow purpose. Some exercise devices require a person to maintain balance and equilibrium. A large inflatable ball (for example, 65 cm), known as a Swiss ball, has been used for this purpose. While the ball is useful for certain stability training exercises, standing upon the ball or staying atop the ball requires a high degree of skill and is inappropriate for most. In U.S. Pat. No. 4,801,140 a person suffering from a physical disability can stand on the flat side of a non-inflatable molded foam hemisphere to practice balancing. The practical disadvantage of this design is that a high degree of skill is required before someone can actually stand on such an unstable platform. Without assistance from a therapist or additional balancing accessories, this platform is accessible only to trained athletes. In U.S. Pat. No. 5,810,703 the underside of a small board is fitted with a smaller spherical projection. The relatively small diameter of the spherical projection tends to make the board relatively unstable. The height of the spherical projection can be set to one of three discrete settings. Overall, the adjustment has little range and resolution. Also, the projection, if inverted to face upwardly, is too small to allow a person to perform an exercise while placing weight on the projection. An inflated cushion in the shape of a disk (sold under the name DuraDisk through C.H.E.K. Institute) has been described as useful for certain exercises. This cushion is described as needing no inflation, but the product is shipped with an inflation valve that the user has access to. A separate wooden platform, 20 inches in diameter, is sold for the purpose of placing the platform over the cushion to create a balance board. This cushion is relatively flat and therefore offers little challenge to a user. It is not useful for the inflatable disk to be placed on the board as this would offer no advantage over putting the inflatable disk on the floor. Also, the use of a separate platform requires careful placement and centering of the platform and also introduces the need for regularly finding and associating the separate parts. In U.S. Pat. No. 5,643,154 a relatively squat, rounded ballast is mounted under a relatively wide platform. If the user is willing to stock an inventory, the rounded ballast can be a changed, but the individual ballasts are not adjustable. This device is designed for use on land or in water. For use in water, an edge bumper is inflated an adjustable amount to reach the desired buoyancy. While this edge bumper is adjustable, this adjustment is only effective in water. The stability of the platform on land will not be substantially affected by adjusting an edge bumper, which inherently provides a stable base. See also U.S. Pat. No. 3,024,021 for a non-adjustable device employing a platform connected through a resilient member to a rounded base. U.S. Pat. No. 5,643,165 shows a frustroconical balancing device with a flattened apex. This device is stable in only one central position, and becomes highly unstable once tilted slightly. Furthermore, the stability of this device is not adjustable. See also U.S. Pat. No. 5,549,536 for a continually tilted platform. Accordingly, there is a need for an improved device that can allow adjustment, preferably with an inflatable device, to accommodate persons with different levels of skills and capabilities. SUMMARY OF THE INVENTION In accordance with the illustrative embodiments demonstrating features and advantages of the present invention, there is provided a device for physical therapy, conditioning or training. The device has a support platform and a flexible member. The flexible member is affixed to, and has a bowl-shaped distention projecting from, one side of the platform. This flexible member is inflatable to a pressure for supporting a person. In accordance with another aspect of the invention there is provided, a method for physical therapy, conditioning or training. The method employs an inflatable device having a flexible member distending from a platform. The method includes the step of inflating the inflatable device. Another step is placing at least some of the weight of a person on said inflatable device. The method also includes the steps of removing the weight of the person and changing the pressure in the inflatable device to change its stability. Another step is again placing at least some of the weight of a person on said inflatable device. By employing devices and methods of the foregoing type, a variety of exercises can be performed by persons of varying levels of skills and capabilities. In a preferred embodiment a flexible, sheet-like member is affixed along the edge of a rigid circular platform, though other non-circular outlines are contemplated. This preferred, sheet-like member can be inflated by a valve installed, for example, in the center of the platform. When inflated, the flexible, sheet-like member forms a domed or hemispherical surface, at least before being loaded. In some embodiments a circular panel can be attached to the underside of the platform to sandwich between them an edge of the flexible, sheet-like member. The edge of the platform may have an upwardly extending lip formed by either rolling the edge of the platform, or by attaching a bead to the platform's edge. In some embodiments the edge of the flexible, sheet-like member can be sandwiched between the bead and the platform. In some cases the user may place the flexible, sheet-like member on the ground and then stand on the platform to enhance the user's balance. The stability of the platform can be altered by adjusting the pressure behind the flexible, sheet-like member. In other cases the user may place the platform on the ground and then stand on the inflated flexible, sheet-like member. This orientation may facilitate balance exercises, or toe extensions that exercise the calves. Numerous other exercises can be performed when the person uses the flexible, sheet-like member for sitting or supporting a hand, foot, extremity, etc., while performing situps, squats, lunges, etc. BRIEF DESCRIPTION OF THE DRAWINGS The above brief description as well as other objects, features and advantages of the present invention will be more fully appreciated by reference to the following detailed description of presently preferred but nonetheless illustrative embodiments in accordance with the present invention when taken in conjunction with the accompanying drawings, wherein: FIG. 1 is an axonometric view of a device in accordance with principles of the present invention; FIG. 2 is a side elevational view of the device of FIG. 1, showing various levels of distension; FIG. 3 is a detailed, fragmentary, cross-sectional view of the device of FIG. 1, but modified to include an additional bead; FIG. 4 is a detailed, fragmentary, cross-sectional view of a device that is an alternate to that of FIG. 2; FIG. 5 is a detailed, fragmentary, cross-sectional view of a device that is an alternate to that of FIG. 2; FIG. 6 is a plan view of a device that is an alternate to that of FIG. 1; and FIGS. 7A-7D show the device of FIG. 1 being used in a variety of exercises. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIGS. 1 and 2, the illustrated device has a support platform 10 with a circular outline, although other outlines are contemplated (elliptical, polygonal, etc.). Platform 10 can be made of wood, plastic, metal, or other materials. A flexible sheet-like member in the form of an elastomeric sheet 12 is shown secured to the edge of platform 10 . The edge of sheet-like member 12 is attached with an airtight seal to platform 10 by glueing, by clamps, or by other sealing means. Sheet-like member 12 can be made of any one of a variety of materials, including natural and synthetic rubbers, plastics, etc. Also, in some embodiments sheet-like member 12 may be a laminate having an outer surface that is more durable and skid resistant. Sheet-like member 12 may be formed by blow molding or otherwise to have a natural hemispherical shape. This hemispherical shape preferably has a diameter of 18 to 36 inches (46 to 91 cm), although other dimensions are contemplated. It will be appreciated, however, that under normal use, and when loaded, the sheet-like member 12 will have a profile that is more complex than a hemisphere. In other embodiments, sheet-like member 12 may start as a flat circular sheet that distends when inflated into a dome (taking essentially a hemispherical shape when unloaded). A valve means 14 is mounted in a center hole in platform 10 . The valve means 14 may be a rubber bushing covered on its inside with a flexible flap that acts as a check valve. Valves of this type are used to inflate basketballs, footballs, etc. If the device need only be inflated to a relatively low pressure, a tube with a stopper can permit a user to blow into the tube to inflate the device, as is done with inflatable beach balls, and the like. Various other types of valves can be used in different embodiments, depending upon the desired pressure, pumping method, etc. Also, valve 14 can be located on alternate positions on platform 10 , or on various positions on sheet-like member 12 . Referring to FIGS. 1 and 3, a circular deck 16 is shown as an element attached to the underside of platform 10 by means of screws 18 , although other types of fasteners may be used instead. The edge of sheet-like member 12 is shown sandwiched between platform 10 and underlying deck 16 . The seal at the edge of sheet-like member 12 can be enhanced by using an appropriate glue, caulk, gasket compound, or other sealing material. The hole holding valve means 14 is aligned with hole 20 in underlying deck 16 , although such alignment is unnecessary, and in some embodiments a number of spaced holes may be used instead. Platform 10 and deck 16 may be made of different materials, so that the outer surface may be flexible and skid proof, while the inside deck may be rigid and able to bear heavy loads. In still other embodiments, underlying deck 16 may be replaced with a hoop or other annular structure to simply concentrate on its function of acting as an affixing means for sealing sheet-like member 12 to platform 10 . The edge of platform 10 is fitted with an annular bead 22 . Bead 22 may be secured by glueing or by various fasteners. Also, bead 22 may have a variety of shapes. Bead 22 can be formed of a length of extruded rubber or plastic that is closed into a loop. Alternatively, bead 22 may be initially molded as an annulus. Preferably, the top of bead 22 rises above the surface of platform 10 to provide a small barrier that tends to keep a user's feet on the platform. Also in preferred embodiments, bead 22 may be relatively soft material that prevents injury caused by the user accidentally kicking or otherwise colliding with the edge of platform 10 . Referring to FIG. 4, alternate platform 10 ′ is similar to the previously described platform, but with a peripheral recess 24 . An annular bead 26 is shown fitted in recess 24 , while sandwiched between them is previously mentioned sheet-like member 12 . As before, bead 26 may be a molded annulus or may be formed from a length of extruded material that is closed into a loop. Alternatively, the edge of sheet-like member 12 may be sealed into recess 24 before molding bead 26 in situ. Bead 26 has an outside surface that is coplanar with the outside surface of platform 10 ′ to facilitate situations where the device is placed with platform 10 ′ down, for certain exercises to be described presently. Referring to FIG. 5, previously mentioned deck 16 is shown attached by means of screws 18 to alternate platform 10 ″. Also as before, sheet-like member 12 is sandwiched between elements 10 ″ and 16 . Platform 10 ″ has an integral edge 28 that is rolled. Platform 10 ″ maybe shaped by molding, stamping, bending, etc. Referring to FIG. 6, an alternate platform 10 ′″ is generally rectangular with rounded corners. Platform 10 ′″ to be dimensioned to simulate the general size and feel of a skate board or snowboard. Here, two inflatable domes 30 are sealed to the underside of platform 10 ′″ using structure and techniques similar to that previously described. The domes 30 are arranged so that the platform 10 ′″ can roll (rotation about a longitudinal axis) fairly easily, but cannot pitch unless the user places significant weight at the front or back of the platform 10 ′″. To facilitate an understanding of the principles associated with the foregoing apparatus, the use of the device of FIG. 1 will be briefly described. The user will initially inflate the device by inserting a pump needle through valve means 14 . The sheet-like member 12 will be inflated and will distend accordingly. With a modest level of inflation, sheet-like member 12 will take the hemispherical shape 12 A shown in FIG. 2 when unloaded (that is, when suspended so that the sheet-like member 12 does not touch the ground). The foregoing device may be used with the platform 10 resting on the ground as shown in FIG. 7 A. Here, a person P stands on sheet-like member 12 , working to maintain balance. For an especially challenging session, a person can stand on one foot. The difficulty can be further increased if the person to P rolls or tilts the head, with or without the eyes closed. Another, surprisingly challenging session can consist of simply kneeling on the sheet-like member 12 . This effort can be reduced for a novice by getting down on all fours and then working to maintain balance. The person P may mount sheet-like member 12 in order to receive various benefits. The user may perform an exercise in order to improve the user's sense of balance. In some cases, the user may suffer from a disability that affects coordination and balance. Therefore, the device can be used to improve motor skills and balance as a form of therapy. In other cases, an athlete may wish to improve balance for any one of a number of sports requiring a refined sense of balance. Alternatively, the user may stand on member 12 simply to exercise his or her muscles. Of course, some users will stand on member 12 simply for enjoyment. The amount of exercise sustained by mounting the device can be substantial. The person maintaining balance will normally be required to make many rapid and urgent posture adjustments by exerting a wide range of muscles. Moreover, this effort takes place with a sense of stimulation and excitement that makes the effort challenging and interesting. Thus, the user can quickly reach a high level of exertion without the usual sense of tedium or labor. As the user's balance, coordination, and endurance improve, the user may wish to increase the level of difficulty. Accordingly, the pressure within the device can be decreased by venting valve means 14 . This reduced pressure leads to less sure footing and increased effort to maintain balance. Alternatively, the pressure can be increased to accommodate an especially difficult routine, or to accommodate a user that is tired or less experienced. This increased pressure corresponds to more stability, since the sheet-like member 12 is less able to shift underneath the user. An advantage with the foregoing pressure adjustment is that the user can continuously and finely adjust the pressure and the level of difficulty to suit his or her personal needs. Because the device can be adjusted to become relatively stable, the user can readily perform ordinary exercises. For example, the user can squat, or stretch and stand on his or her toes as an exercise. Such exercises provide the dual benefit of conditioning muscles, while simultaneously training a person to maintain balance. Other exercises are contemplated, such as leg kicks, knee lifts, etc. A person P can also sit on sheet-like member 12 as shown in FIG. 7B to perform situps. Here, the user can decrease the level of difficulty by shifting forward to reduce the amount of upper body weight that is cantilevered out past the device. An additional advantage is that sheet-like member 12 can conform to the user's body and support the lower back as the user leans back. Decreasing the pressure within sheet-like member 12 can increase the amount of lower back support under such circumstances. Various other exercises can be performed on the inverted device. As shown in FIG. 7C, person P can perform lunges. In fact, many of the exercises that are performed in step aerobics classes can be performed with the presently disclosed device. One advantage with this mode of use is that the exercise is very low impact, since sheet-like member 12 acts like a cushion. Again, the pressure behind sheet-like member 12 can be adjusted to change the level of difficulty. Also, the cushioning effect of sheet-like member 12 can make the exercises low impact, which is very important in step aerobics in order to avoid the joint injury that commonly occur with long-term use. The foregoing device need not be used with the platform down, but may be inverted at shown in FIG. 7 D. Because the device is inherently less stable when inverted as in FIG. 7D, the user will receive a more vigorous experience, which may be appropriate for athletic training. When placed on the ground (level G 1 of FIG. 2) in order to support a person as shown in FIG. 7D, sheet-like member 12 will become more squat and take the outline 12 A shown in phantom in FIG. 2 . This is a relatively stable condition and the user can maintain balance while standing on platform 10 without too much difficulty. Pressure can then be increased by reattaching a pump to valve means 14 . Sheet-like member 12 may then be pressurized to distend further and take the outline 12 B shown in phantom in FIG. 2, when placed on the ground at level G 2 . Outline 12 B is closer to hemispherical and will make the platform 10 less stable. If the device is built sufficiently strong to sustain a very high pressure, sheet-like member 12 can distend to the almost precisely hemispherical shape shown in full line in FIG. 2 . This represents the highest level of difficulty, requiring a high level of skill and endurance. Obviously, many 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.

1a

FIELD OF THE INVENTION The present invention relates to obtaining flow information of a conductive fluid in a conduit. More particularly, the present invention relates to using passively detected electrical voltage generated by a pulsating liquid flow, known as streaming potentials, to obtain velocity information. In one particular adaptation, the present invention provides a means for determining the presence of abnormal blood flow between the heart and the particular artery being investigated. BACKGROUND OF THE INVENTION There has been a lot of recent activtity in the non-invasive study of the cardiovascular system. Traditional methods, such as angiography, usually relied on some invasion into the blood vessels. A disadvantage of invasive techniques is the risk of infection, increased mortality risks and increased morbidity risks. For example, there is a one to five percent mortality rate from angiography. Furthermore, those surviving patients often have traumatic reactions to the injected dye. In particular, increased attention has been focused on obtaining a diagnostic indicator of flow problems throughout the arterial tree. Unfortunately, most methods presently in use have significant detractions. One method recently gaining popularity is the use of ultrasound Doppler velocity meters. This process is described in articles such as the ones by Max Anliker, "Diagnostic Analysis of Arterial Flow Pulses In Man;" Cardiovascular System Dynamics, Beran et al, Eds. (1978) and Gosling and King, "Continuous Wave Ultrasound As An Alternative and Complement To X-rays In Vascular Examinations;" Cardiovascular Applications Of Ultrasound, R. Reneman Ed. (1974). The principal drawbacks in using ultrasound are the complex equipment that is needed, the trained technicians and diagnosticians that are required, the complexity of the procedure and the propensity for error based on incorrect vessel diameter and incorrect relative flow directions, and the inability to use the method as a quick screening test to determine potential problems. Another approach in the investigation of arterial flow is disclosed in the Findl et al. U.S. Pat. No. 4,166,455. This patent disclosed the theoretical basis for using the electrokinetic phenomenon known as streaming potential to determine reduced flow. That patent, which is incorporated in its entirety herein by reference, discloses a method and a sensor for detecting electrical voltages measured on the skin surface. While that method is satisfactory for locating certain lesions located in arteries near the skin surface, it does not provide a method for overall screening purposes to determine whether there is abnormal flow in the arterial tree. None of the prior art methods and apparatuses provide a simple, inexpensive screening technique for monitoring the changes in blood flow caused by disease stages, traumatic injuries and other factors. Thus, there is the need for inexpensive, uncomplicated, and easy to use apparatus for rapidly screening individuals to detect problems in the cardiovascular system. SUMMARY OF THE INVENTION The present invention provides a simple, non-invasive technique and apparatus for obtaining flow information about a conductive fluid flowing in a pulsatile manner through a conduit. Although any types of conductive fluids can be monitored, such as sea water, dissolved chemicals, reactants in chemical processes, and the like, one presently preferred use of the present invention is for detecting cardiovascular problems in animals, and in particular in human beings. The present invention provides a simple, inexpensive technique and apparatus for monitoring, measuring, and analyzing pertinent hemodynamic information. Abnormal blood velocity caused, for example, by lesions and arteriosclerosis located between the heart the the sampling portion or between two sampling points can quickly and easily be determined. The present invention is based upon the scientific concept of the electrokinetic phenomenon known as streaming potential. This phenomenon can be explained on the basis of Helmholtz' theory of an electrochemical double layer at all liquid-solid interfaces. The streaming potential phenomenon is believed to result by the mechanical perturbation that occurs when the solid, such as the walls of a conduit, is stationary and the liquid is moving. It appears that the fluid flow past the solid interface shears the mobile portion of the double layer in such a way that the predominant ions in the region are displaced in the direction of flow. It is this ion displacement that results in the streaming potential. In a fluid system in which there is pulsatile flow, the flow pulses originate at the pulsatile pump and are transmitted throughout the fluid system. The streaming potential related to the pulse of fluid that is pumped can be measured throughout the entire conduit system. In general, the magnitude of the streaming potential varies with the length of the conduit between the electrodes, with the dielectric constant and the zeta potential, and with the fluid velocity; and varies inversely with the conduit diameter and the electrolyte conductivity. The degree of variation of the streaming potential with each of the variables also depends upon whether the flow is laminar or turbulent. A particular embodiment of the present invention is connected with blood flow through the arterial tree. As an exemplary only embodiment of the present invention, the present invention will be discussed in this patent application with respect to blood flow in animals. The streaming potential measurements of animals were reported at least as early as 1975 by Sawyer et al, Coronary Artery Medicine and Surgery--Concepts and Controversies. This investigation utilized electrodes directly placed in contact with the blood flowing in the femoral arteries of dogs and used the streaming potential to determine the zeta potential of the arteries. However, such electrodes when experiencing flow at their surfaces do not accurately measure streaming potentials because of another electrokinetic phenomenon known as the motoelectric potential effect. This artifact is generally of the same order of magnitude as the streaming potential. Although measurements from the surface of the vessel are more difficult to obtain, they are more accurate and reproducible. One such result of that observation was the subject of the aforementioned Findl et al U.S. Pat. No. 4,166,455. That patent discussed the fact that the streaming potential increased when the electrodes straddled the site of a partial flow blockage at least for the reasons that the flow at the location was faster and perhaps because the flow was also turbulent. On the other hand, the present invention provides a technique for monitoring blood velocity with one application being a rapid method for detecting blockages between the heart and the location of the monitoring electrodes. Although the present invention does not give the exact location of the blockage, it does have the advantage of being a rapid, easy, and inexpensive method of screening for the existence and approximate location of such a partial blockage. Peripheral vascular diseases result in modifications of blood flow characteristics that can give an indication of the presence of these diseases. By detecting the streaming potential at various locations in the peripheral blood flow, the present procedure being denoted electroarteriography (EAG), rather subtle changes in the peripheral blood velocity profile can be detected. In arteriosclerosis (hardening of the arteries), the pressure pulse from the heart actually travels faster than it does in healthy individuals. In healthy individuals, the artery wall is pliable which results in a slower pressure pulse. In atherosclerosis (lesions in the arteries) the pressure pulse from the heart is slowed by the blockage. Under presently accepted theory, the contracting heart by forcing a pulse of blood into the arterial tree, generates a pressure pulse that causes the blood nearest the artery wall to begin flowing first. This flow generates streaming potentials that can be detected to provide the most accurate velocity waveform. A particular aspect of the present invention relates to a passive method for detecting the presence of abnormal flow of a conductive fluid in a conduit downstream from a pulsatile pumping source. The method comprises placing first and second, spaced apart, passive electrodes in electrical contact with respective portions of the conduit downstream from the pumping source, detecting the resultant electrical signal, and comparing a characteristic of the signal with a similarly detected signal from a conduit having normal flow. The apparatus according to another aspect of the present invention provides a means for non-invasively detecting abnormal blood flow downstream of the heart of an animal. The apparatus comprises means for detecting the streaming potential and producing a signal in response thereto, means for detecting the ECG signal; and means for permitting simultaneous comparison of the streaming potential and the ECG signal. A further apparatus embodiment of the present invention, also capable of being used for non-medical purposes, comprises a differential amplifier means, first and second passive electrodes connected to two inputs of the differential amplifier, and a third passive electrode for providing a common mode rejection signal to the "ground" or "common" connection of the differential amplifier. Further electrode means are provided for detecting a pumping signal from a pulsatile pump that is generated at the beginning of the pumping of a pulse of fluid. There is also provided means for permitting simultaneous comparison of the differential amplifier output signal and of the pumping signal. These and other objects and advantages of the present invention will be discussed in or become apparent from the detailed description of the presently preferred embodiment contained hereinbelow. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram depicting the figure of a human being with electrode placement combined with an electrical schematic of a particular embodiment of the present invention. FIGS. 1a, 1b, and 1c are reproductions of sample signals obtained using the method of the present invention at the indicated cuff pressures. FIG. 2 is a graphical portrayal of a typical electrocardiogram and several electroarteriograms of different types of peripheral arterial blood flow. FIG. 3 is a perspective view of one embodiment of the electrodes of the present invention. FIG. 4 is a perspective view of a further embodiment of electrodes of the present invention. FIG. 5 is a cross-sectional view taken along line 5--5 of FIG. 4. FIG. 6 is a graphical plot of normal T 2 times (time between the R pulse of the ECG and the subsequent EAG pulse) plotted as a function of the age of the individual. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings in which like elements are represented by like numerals throughout the several views, and in particular with reference to FIG. 1, the electroarteriography (EAG) apparatus 10 is depicted. EAG apparatus 10 comprises an EAG sensor 12, an electronic processing circuit 14, and a signal analyzing means such as oscilloscope 16. EAG apparatus 10 is shown connected to a test subject shown in the prone position. Attached to each arm of the subject are conventional electrocardiogram (ECG) electrodes 18 and 20. A conventional, air inflatable cuff 22, such as those used for taking blood pressure, is shown placed between the location of EAG sensor 12 and the patient's heart. Cuff 22 has a conventional, air inflating device such as a rubber bulb 24 and an indicating pressure gauge 26. Thus, when cuff 22 is inflated by repeatedly compressing and releasing bulb 24, the amount of pressure can be read on gauge 26. Obviously, as cuff 22 is inflated to a higher and higher pressure, the amount of blood flow on the distal side of cuff 22 from the heart will decrease. At pressures above systolic, an inflation pressure of approximately 150 millimeters of mercury, a complete cut-off of the blood flow beyond cuff 22 occurs and the EAG signal disappears. EAG sensor 12 is depicted in FIG. 1 as being connected for measurement of blood flowing through the dorsalis pedis artery. Also shown in FIG. 1 at 12' is an alternate EAG sensor site to measure the blood flowing through the radial artery. Other locations for the EAG sensor can include the neck for monitoring the carotid artery; on the inside, lower side of the foot to monitor the posterior tibial artery; on the inside of the elbow to monitor the brachial artery; and on the anterior inner part of the thigh to monitor the femoral artery. The precise EAG sensor locations are illustrative only and are not meant to be either all inclusive or to be limiting. The EAG signal, described in greater detail hereinbelow, will vary in both the shape of the signal and the magnitude of the signal depending upon the particular location of EAG sensor 12. For illustrative purposes, the results of the EAG signal taken from the dorsalis pedis artery will be discussed and compared for various physiological conditions in the remainder of this application. EAG sensor 12 comprises an EAG electrode or pad 28, a means for attaching pad 28 to the body, such as an adjustable band 30, and a common mode signal electrode 32. With reference to FIG. 3, EAG pad 28 is comprised of a body 34, two electrode pads 36 and 38 housed in cavities in body 34, and silver wires 40 and 42 respectively adhered to the back of electrode pads 36 and 38. Body 34 is preferably flexible to conform with the shape of the subject and is non-conductive. For example, body 34 can be molded from RTV or silicone rubber and have exemplary dimensions of 230 square millimeters. Electrode pads 36 and 38 are preferably molded from flexible silver filled silicone rubber and are located relatively closely to each other. Electrode pads 36 and 38 have exemplary dimensions of 3 millimeters by 14 millimeters and can be spaced apart from 6 millimeters to 15 millimeters on center with a presently preferred spacing of 10 millimeters. Electrode pads 36 and 38 are located in cavities in body 34 and extend below the outer surface thereof. The space above the tops of electrode pads 36 and 38 is filled with a conventional electrode jelly 50. As clearly shown in FIG. 5, the inside surface of EAG pad 28, that is the side to be placed on the skin of the subject, has a plurality of isolation ridges to assure electrical isolation between electrode pads 36 and 38. Annular ridges 44 and 46 (see also FIG. 3) surround electrode pads 36 and 38, respectively, and an elongate ridge 48 extending transversely on body 34 between the inward parts of annular ridges 44 and 46 further isolates electrode pads 36 and 38 from each other. Because electrode jelly tends to migrate when heated by the body, ridges 44, 46 and 48 assure that such migration is contained and does not affect the mutual electrical isolation of electrode pads 36 and 38. Thus, EAG pad 28 is completely flexible and reusable and can easily conform to the particular shape of the body portion on which it is applied. Most importantly, EAG pad can be firmly mounted over an artery without occluding the artery. The electrode spacing is fixed to provide consistent results and the electrode size and electrical contact area with the skin is minimal to reduce electrical artifacts. Common mode signal electrode 32 can be either a conventional ECG electrode or can be used in combination with EAG pad 28, as shown in FIGS. 3 and 4 and denoted 32' and 32" respectively. Electrode 32' and 32" are silver filled silicone rubber electrodes that have an "H" configuration, and an annular square configuration, respectively. Electrodes 32' and 32" have a size and configuration so as to permit electrode pads 36 and 38 to contact the skin of the subject. Other configurations, such as two parallel strips, can obviously be used. Electrode 32' as depicted in FIG. 3 has a size such that it will be contained within the perimeter of body 34, whereas the electrode 32" as depicted in FIG. 4 has a size such that its annular opening will receive body 34. In both cases, common mode signal electrode 32 is designed to be closely spaced to electrode pads 36 and 38. Alternatively, as depicted in FIG. 1, electrode 32 is placed on the subject at a location that is spaced from EAG pad 28. Such an electrode 32 can be typically placed on a bony area (e.g., the patella or the fibula) to reduce the possibility of electrode 32 sensing an EAG signal. A wire 52 is mounted on electrode 32 and can be easily connected to electronic processing circuit 14. As shown in FIG. 1, electronic processing circuit 14 includes a front end differential amplifier 54 having at least two signal inputs and a common input. Wires 40 and 42 are electrically connected to the signal inputs of differential amplifier 54 and wire 52 is electrically connected to the common input of differential amplifier 54. Although an ideal differential amplifier will not respond to the common difference between the input signals, a practical differential amplifier will in fact measure a difference between two symmetrical input signals and amplify that difference. The ability of a practical differential amplifier to reject the common signal between the two inputs is denoted the common mode rejection ratio (CMRR). Typical CMRR are 10 6 which means that a common one volt signal will appear as a microvolt artifact. Because the EAG signal is of the same order of magnitude (e.g. 1 to 2 microvolts), this is a significant error. The common signal to both inputs is usually generated by the omnipresent 60 hertz noise as well as the ECG and EMG signals from the patient. Electrode 32 when placed so as not to measure an EAG signal and when connected to the common connection of differential amplifier 54 greatly enhances the performance of circuit 14. As a result, a hundred fold increase in EAG signal magnitude over the noise level was obtainable. Differential amplifier 54 can have a common mode rejection ratio of 100 db with a differential impedance of 10 12 ohms, a common mode impedance of 10 12 ohms, and a noise level of 5 microvolts RMS in a frequency range from 10 to 500 hertz. As a result of using the common mode signal electrode 32 connected to the ground connection of differential amplifier 54, the overall common mode rejection of differential amplifier 54 is increased to 150 db. The output from differential amplifier 54 is fed through a filter 56 and a range select conventional amplifier 58 to a conventional isolation amplifier 60. Filter 56 can be a conventional two pole butterworthy band-pass filter in the 0.5 to 40 hertz band. The power for isolation amplifier 60 is provided from a power supply 62 fed through an isolator 64. In this way, a signal with no ground currents can be obtained. The output from isolation amplifier 60 is connected through an output buffer 66 to the output connection of circuit 14. As mentioned above, the input signal levels to circuit 14 are typically in the low microvolt range whereas the output signals therefrom are typically in the low millivolt range. Depending upon the setting of amplifier 58, the overall gain of circuit 14 can be 100, 1,000, or 10,000 and, as mentioned above, the overall common mode rejection ratio is 150 db at 60 hertz. The outut from electronic processing circuit 14 is connected through a grounded coaxial cable 68 to the channel A input of oscilloscope 16. For the purposes of easy comparison, the output of circuit 14 is connected to oscilloscope 16 such that forward flow causes a negative signal. Although an oscilloscope 16 is disclosed in FIG. 1, it should be obvious that the same connections can be made to an ECG recorder or other signal recording or storage devices. As shown in FIG. 1, the performing of the method according to the present invention in the embodiment of electroarteriography comprises the placement of ECG electrodes on a subject that is prone on a bed or similar platform. Two ECG type electrodes are placed on one arm and one on the other arm. Depending upon the portion of the arterial tree to be screened, the artery of interest is located by either palpation or by use of a conventional sonic detector. The dorsalis pedis artery was selected for EAG pad 28 and the radial artery was selected for EAG pad 28'. Discussing only the signals from the dorsalis pedis artery, EAG pad 38 is placed on the skin of the subject directly over the artery with electrode pad 36 and 38 placed so that it is upstream of the other pad 38 or 36. EAG pad 28 is held in place by an appropriate means such as an adjustable strap or band 30 that is attached so as not to occlude the artery. Common mode signal electrode 32 is then attached over a bony portion of the foot of the subject and all three electrodes are connected, as discussed above, to circuit 14. Circuit 14 is then connected to the channel A input of oscilloscope 16. FIG. 1a shows the waveform obtained from both the EAG pad 28, at the top of the graph, and the ECG waveform from ECG electrodes 18 and 20 shown at the bottom of the graph. Reference is also made to the top two wave forms in FIG. 2 where the top waveform is the ECG signal and the bottom waveform is an EAG signal that has not been inverted. A typical ECG waveform consists of a series of complex pulses which are believed to be the result of electrical signals sent to stimulate the pumping action of the heart. A typical pumping action from the heart results in a first forward flow of flood through the arteries, a small reversal of that blood flow, and a subsequent forward flow of the blood. The particular blood flow is believed to be correlated with the ECG waveform. As shown in FIG. 2, the ECG complex wave has a small positive segment labelled "P", followed by a small negative part, denoted "Q", which immediately precedes a large spiked pulse denoted "R". The end of the R portion is a small negative portion, denoted "S" which slowly rises to a medium size positive pulse portion, denoted "T". Thus, the standard ECG waveform is comprised of a complex "PQRST" pulse. Because of the regular form of the ECG pulses, they cannot only be used as timing pulses, but they can also be used to trigger an oscilloscope in a known manner. In fact. the FIGS. 1a, 1b, and 1c are reproductions of actual signals obtained from human test subjects in which the oscilloscope was triggered by the R portion of the ECG. A principal discovery underlying the present invention is that the streaming potential produces a measurable signal having a complex waveform resulting from the forward-backward-forward flow of blood through the arteries. The shape of this waveform and the relative timing of the waveform with respect to the ECG waveform can determine whether the flow through the arteries is normal, is reduced because of some lesion, disease or traumatic injury is the arterial tree between the heart and the location of the EAG electrodes, or is too fast, being indicative of arteriosclerosis. With particular reference to FIG. 2, a normal dorsalis pedis EAG consists of a first, large positive peak, denoted 70, a second, small negative peak denoted 72, and a small positive peak denoted 74. The time between the R peak of the ECG signal and peak 70 of the EAG signal is denoted the T 2 time and is a function of the time delay between the contraction of the heart and the subsequent pulse of blood flowing past the particular EAG electrode. The further the placement of the EAG electrode from the heart, the greater the T 2 time. Similarly, the T 2 time will be increased if the blood flow is uphill, such as with the leg raised above the heart, than with the blood flow that is downhill, such as in a standing subject. Other time portions of the EAG signal is the time from peak 70 to peak 72, the T 3 time, the time from peak 72 to peak 74, the T 4 time, and the pulse width of peak 70, the T 5 time. The T 1 time, shown in the upper graph in FIG. 2, is the time between heartbeats and is measured between the two R peaks of the ECG signal. Other usable characteristics of the EAG signal is the height of peak 70, denoted P 1 ; the height of peak 72, denoted P 2 ; and the height of peak 74, denoted P 3 . More particularly, it has been found that while the absolute value of the amplitude of these peaks may vary from day to day as a result of artifacts, the ratio of the peak amplitudes apparently remains constant. In order to simulate the effects of different amounts of restrictions to the blood flow, a blood pressure cuff 22 was placed on the thigh of the subject and inflated to various pressures from 0 through systolic pressure for the individual subject to a cut-off pressure. As mentioned above, FIG. 1a shows the result with no pressure in cuff 22, FIG. 1b shows the results of 40 millimeters (Hg) of pressure in cuff 22, and FIG. 1c shows the result with 80 millimeters (Hg) of pressure in cuff 22. Other studies performed on a subject with a known traumatic injury to the left foot resulting in permanent inflammatory edema confirmed that there is a dramatic difference in the EAG signal obtained from the normal foot than from the pathologic foot. The normal foot contained the typical EAG waveform as shown in FIG. 1a or at the second curve from the top in FIG. 2, whereas the pathological foot had an EAG signal that was very broad, lacking well defined flow reversal, and that began late in the cycle as shown in FIG. 2. A study of various EAG signals indicates that the signals vary with a number of factors. These factors include the location at which the signal is obtained, the heartbeat of the subject (e.g. taken while the subject is at complete rest or after the subject has walked on a treadmill), and the location and extent of blockage of blood flow. In addition, possibly because of inconsistent electrode placement techniques, the absolute amplitude of the EAG signal may vary from test to test. Reliable modifications of an EAG signal from an average signal that reflect predicted hemodynamic changes include the broadening of the pulse width (T 5 greater), lack of flow reversal (P 2 equals zero), a decrease in ratios of signal amplitude (P 2 /P 1 ), and the length of time between the peak of the ECG QRS wave and the peak of the subsequent EAG wave (T 2 time). In addition, possibly because of inconsistent electrode pressures, the absolute amplitude of the EAG wave parts may vary from test to test. A review of FIG. 1b, 1c and the middle waveform in FIG. 2, shows that with increasing pressure in cuff 22, P 1 decreases, pulses 72 and 74 become less defined, and T 2 increases. In fact, the middle wave in FIG. 2 is so distorted that it could simply be due to background noise. The bottom two waveforms in FIG. 2 show other effects on the EAG signal from reduced blood flow. With reference now to FIG. 6, the T 2 transit times for non-symptomatic "normal" subjects obtained from the dorsalis pedis artery are depicted as falling within a normal band of values shown by the two dashed lines. The T 2 times were found to decrease with age and this is believed to be the result of the tendency of arteries to harden with age and the tendency of blood pressure to increase with age. Hardening of the arteries (arteriosclerosis) lowered the transit time by decreasing the ability of the arterial wall to flex, making the artery more like a rigid tube. The lowered wall compliance translates into a faster blood flow and a decreased T 2 . Not shown in FIG. 6 is the effect of the height of the person, or rather the distance from the heart to the EAG sensor. It has been found that there is an increase in T 2 time on the order of 20 to 40 milliseconds for a distance of one foot. Although there are numerous factors which result in the variation of the T 2 time, it has been found that whenever the T 2 time falls outside of the "normal" range, (i.e., is too large or too small based on the age of the subject) there is probably an abnormality in the blood velocity and further examination is warranted. Such further examination can be a detailed analysis of the EAG waveform or the use of other means to confirm the presence of atherosclerosis or arteriosclerosis, or some other possible damage to the arterial tree. Two clinical tests shown in Table I below illustrate the utility of the T 2 time. TABLE I______________________________________Patient Info. T.sub.2 time (msec)Age Sex R. Leg L. Leg Diagnosis______________________________________90 M 230 360 Atherosclerosis present in left leg. (Confirmed by angiography.) Right leg borderline normal. Arteriosclerosis in excess of normal for age suspected.68 M 780 890 Severe atherosclerosis in both legs. Blood flow seriously reduced. (Confirmed by angiography.)______________________________________ From experimental results, 86% of the trials indicated waveforms as depicted in FIGS. 1a, 1b, and 1c. A 10 to 20% increase in T 2 time usually accompanied cuff pressures at or below the diastolic pressure of the subject. In fact, a 10 to 20% increase in the T 2 time was obtained with an applied cuff pressure of 40 millimeters of mercury. Although the present invention does not necessarily provide a determination of the extent of an occlusion or the exact location of the occlusion, it does provide an easily applied test with immediate results which can be used to determine whether further tests should be done. Application of the present invention, obviously, can be in the preliminary screening for occlusive cardiovascular disease. Other uses, in a non-medical field could be the monitoring of pulsatile flow of a conductive liquid in chemical experiments, in manufacturing processes, and in liquid transportation systems. In fact, the present invention can be used in any fluid transport system in which there is a possibility of an occlusion in the conduit of the system. As described above, the present invention provides a screening process requiring no special signal processing and having a high correlation with the actual blood velocity profile and between the transit time through the vessel and the degree of occlusion in the vessel. The present invention utilizes passive electrodes of a very simple construction. By passive electrodes it is meant an electrode that only receives an electrical signal and is not used to transmit either voltage or current to the vessel being monitored. In addition, a passive electrode does not involve a chemical reaction and is substantially unaltered by the monitoring process. Although one aspect of the present invention utilizing the T 2 time as the measured signal characteristic employs the ECG signal, it is obvious that in both animal and non-animal applications of the present invention a separately generated pumping signal can be used or a second set of electrodes can be placed closer to the pump outlet to provide an initial signal to which the distally detected signal can be compared. Non-animal applications require a conduit that is a poor conductor in the axial direction and conductive in the radial direction (e.g., porous glass). No streaming potentials are generated in axially conductive conduits (e.g. metal) and none can be detected non-invasively in radially non-conductive conduits (e.g. plastic). With respect to the medical applications of the present invention, the present invention provides a reliable, simple and non-invasive blood velocity measurement technique that has substantial value in today's clinical environment. The EAG waveform is remarkably similar to the blood velocity profiles that have been obtained using ultrasound techniques and, as mentioned above, are believed to be more accurate. Because blood is a conductive fluid and because the blood vessel is immersed within a bulk conductor, the streaming potentials from the blood flow through certain arteries can be detected along the skin surface above that artery. The apparatus according to the present invention provides an effective way of measuring and comparing velocity dependent voltage signals produced by streaming potentials. The use of a common mode signal electrode connected to the common input of a differential amplifier permits the low voltage streaming potentials to be detected among the much larger noise signals. The above invention has been described in detail with respect to specific embodiments thereof. However, obvious modifications should be apparent to those skilled in the art.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Applicants claims priority under 35 U.S.C. §119 of Japanese Application No. 2003-395662 filed Nov. 26, 2003. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a method for forwarding ozonated water which is directed, where a use point exist at places separated from an ozonated water producing device, toward suppressing the decrease of the concentration of the ozonated water due to the self-decomposition of dissolved ozone and minimizing the loss of concentration. Particularly, it relates to a method for forwarding ozonated water which is capable of minimizing the loss of ozone and allowing efficient supply of the ozonated water even when the self-decomposition of dissolved ozone by the ultra pure water of high purity is serious. [0004] 2. The Prior Art [0005] Ozone possesses a strong oxidizing power. Due to this characteristic, it is utilized for sterilizing city water and swimming pools, sterilizing foodstuffs, bleaching pulp, and disposing of waste water. The use of ozone is continuing to increase in various fields. Since the techniques were developed for the production of ozone gas and ozonated water of high degree of cleanliness, their utilization has been rapidly expanding in the field of treating and cleaning silicon substrates and other semiconductor materials and liquid crystal panels. [0006] The ozone gas is produced by a method for exposing oxygen gas to silent discharge and a method for electrolyzing ultra pure water, for example. The ozonated water is produced by dissolving in water the ozone gas produced by the method described above. As means to dissolve ozone in water, a method for bubbling ozone gas in water, a method for mixing ozone gas with water by means of an ejector, a method for dissolving ozone gas in water through the medium of a membrane made of TEFLON® (registered trademark for polyethylene fluoride type fiber), and a method for advancing ozone gas into counterflow contact with water flowing down the interior of a packed column have been known. [0007] The ozone in the ozonated water transforms by self-decomposition into oxygen or dissipates as ozone gas into the atmosphere. When the ozonated water is left standing, it suffers loss of dissolved ozone concentration and eventually reverts to the original water. It is, therefore, customary to produce ozonated water in a high concentration and thereafter adjust the concentration of the ozonated water prior to use. [0008] As a means to adjust the concentration of the ozonated water, a method for adjusting the amount of the ozone gas generated in an ozonated water producing device or adjusting the flow rate of the ozonated water during the course of production is available. The method which adjusts the concentration by adjusting the output of the ozonated water producing device is widely adopted because it permits most expeditious and accurate adjustment of the concentration. Since it attains the adjustment by reducing the capacity of the ozonated water producing device, it encounters difficulty in making the most of the capacity of the ozonated water producing device. It possibly incurs difficulty in producing a sudden change of concentration because it offers retarded response to the leading edge and the trailing edge of ozone concentration. A method which lowers the concentration to a level aimed at by promoting the decomposition of the ozonated water is also available for the adjustment of concentration. This method, however, has poor efficiency from the viewpoint of the effective utilization of the ozonated water because it incurs a very large loss of ozone. A method which relies on the dilution of the ozonated water is also available. Since this method has a very simple operating principle, it is actually used for dilution at the use point. [0009] In recent years, as the ultra pure water used for cleaning semiconductor materials is steadily gaining in purity, it has become difficult to produce ozonated water of high concentration. Various grades of ultra pure water are shown in Table 1. The ultra pure water corresponding to the grade 64M is deprived of organic substance by decomposition induced by irradiation of ultraviolet light for the purpose of accomplishing the standard value of total organic carbon (referred to as TOC hereinafter). This irradiation of the ultraviolet light is thought to form one cause for rendering TABLE I Degree of Accumulation and Water Quality Required production of the ozonated water of high concentration difficult. 64K 256K 1M 4M 16M 64M Specific resistance  >17   >17.5 >17.6-18   >18.0 >18.1 >18.2 (MΩ · cm) Fine  >0.2 μm <100 <50 particles  >0.1 μm <10-20 <5 (pieces/ml) >0.05 μm <5 <1 >0.03 μm <10 Viable cells (cfu/l)     <10 3   <10 2  <10 <5 <1 <1 TOC (μgC/l) <100  <30-50 <10-20 <5 <1 Silica (μgSiO 2 /l) <10  <5 <3 <3 <1 Dissolved oxygen (μgO/l) <100  <100 <50 <10 <5 [0010] In the circumstances, methods for preparing the ozonated water of high concentration have been developed. A method which removes hydrogen peroxide, i.e. an ozone decomposing substance, to below 15 μg/L (Patent Document 1) and a method which removes an ozone decomposing substance with a redox catalyst (Patent Document 2 and Patent Document 3) are examples. As a means to prepare the ozonated water of high concentration by lowering the ratio of electrification of ultra pure water, a method of adding such an antistatic substance as an acidic substance or carbon dioxide to ultra pure water (Patent Document 4) is known. Further, as a means to prepare the ozonated water of high concentration by increasing the TOC concentration, a method which adds such a TOC component as isopropyl alcohol (IPA) or acetic acid until a concentration exceeding 15 ppb and not exceeding 250 ppb (Patent Document 5) has been known. [0011] Incidentally, as a means to suppress the fall of the ozone concentration of the ozonated water during the supplying of the ozonated water over a long distance, a method which forwards an ozone-dissolved water and undissolved ozone gas as a gas-liquid mixed fluid and separates this fluid into a gas and a liquid at the use point (Patent Document 6) has been known. This principle purports that even when the ozone on the liquid side self-decomposes during the course of the supplying, the fall of the concentration of ozone is suppressed because the ozone on the gas side is dissolved again. [Patent Document 1] Official gazette of JP-A-2000-15272 [Patent Document 2] Official gazette of JP-A-2000-308815 [Patent Document 3] Official gazette of JP-A-2001-44162 [Patent Document 4] Official gazette of JP-A-2000-262874 [Patent Document 5] Official gazette of JP-A-2002-85947 [Patent Document 6] Official gazette of JP-A-2001-291694 [0018] In Documents 1-3 concerning methods for removing ozone decomposing substances, while it is known that ozone is violently decomposed in a solution containing hydrogen peroxide, it is unclear how much the hydrogen peroxide supposed to be generated in a trace quantity by irradiation of the ultraviolet light promotes the decomposition of ozone. Further, the metallic pollution due to the passage through the redox catalyst of a metallic system of palladium, for example poses a problem. [0019] Document 4 has a sole mention of “a method for producing ozonated water by dissolving ozone gas in ultra pure water through the medium of hollow yarns” which seems to induce large generation of electrification. The present inventors have been ascertained by their study that even by such other methods for the production of ozonated water as the method using a packed column and the method resorting to bubbling which seem to be affected little by electrification, it is not easy to produce the ozonated water of high concentration relative to the water of high purity. It is, therefore, inferred that the acid and carbon dioxide which are added as antistatic substances contribute to suppressing the decomposition of ozone by an action other than prevention of electrification. The pollution caused by the antibiotic substance added to the raw material ultra pure water also poses a problem. [0020] In Document 5, since the TOC component is added to the ultra pure water which has effected necessary removal elaborately by irradiation of the ultraviolet light, the pollution with the TOC component is inevitable. That is, it is proper to remove the impurities in the ultra pure water to the fullest possible extent because the cleanliness of the wafer surface after the cleaning process is largely affected by the water quality of the ultra pure water to be used. By the same token, it is proper to remove the impurities in the ozonated water to the fullest possible extent. The conventional techniques mentioned above, therefore, are improper because they entail unavoidable pollution due to the process and the decline of purity with the additives. [0021] Moreover, the method of Document 6 entails such problems as complicating the apparatus by essentially necessitating such special devices as a gas-liquid mixing unit and a gas-liquid separating unit, requiring supply of excess ozone gas, and possibly lowering the ozone concentration during the gas-liquid separation. SUMMARY OF THE INVENTION [0022] It is an object of the present invention to provide, when ozone or ozonated water of high concentration is obtained by making the most of the adjustment of the output of an ozonated water producing device, a method for efficiently forwarding the ozonated water to the use point by diluting ozone without being decomposed or dissipated. [0023] It is another object to provide a method for effectively forwarding to the use point the ozonated water prepared by using ultra pure water known to incur violent self-decomposition of dissolved ozone. [0024] It is a further object to provide, when the ozonated water is forwarded over a long distance, a method for suppressing the loss of the ozonated water as by decomposition to the smallest possible extent and effectively utilizing the ozonated water. [0025] The present inventors conducted a diligent study concerning the change in the ozone concentration in the ozonated water prepared by dissolving ozone gas in an ultra pure water of high purity corresponding to 64 M. They have consequently found that the ultra pure water of high purity incurs no difficulty in solving ozone gas and exhibits a catalytic action in converting ozone into oxygen. They also found that when the ozonated water of high concentration is diluted under a specific condition, the ozonated water of the optimum concentration can be efficiently supplied at the use point with the wasteful decomposition and dissipation of ozone suppressed. Thus, the present invention has been perfected as a result. [0026] The above mentioned objects are achieved by the following items (1)-(6). [0027] (1) A method for forwarding ozonated water from an ozonated water producing device to a use point and enabling the use point to be supplied with ozonated water having a desired or aimed at concentration, comprises adding a diluting water to a raw material ozonated water in the neighborhood of the ozonated water producing device under a condition inhibiting exposure to an ambient air, adjusting the ozone concentration to a level aimed at the use point, subsequently guiding the ozonated water through a pipe to the use point. [0028] (2) A method for forwarding ozonated water from an ozonated water producing device to a use point separated therefrom and enabling the use point to be supplied with ozonated water having an aimed at or a desired concentration comprising adding a first diluting water to a raw material ozonated water in the neighborhood of the ozonated water producing device under a condition inhibiting exposure to an ambient air thereby adjusting the ozone concentration to a level rather higher than the aimed at concentration desired in the neighborhood of the use point, subsequently guiding the ozonated water through a pipe to the neighborhood of the use point, and further adding a second diluting water thereby adjusting the ozone concentration at the desired level aimed at the use point. [0029] (3) A method set forth in the preceding item (1) or (2), wherein the method of adding the diluting water to the raw material ozonated water under a condition inhibiting exposure to an ambient air consists in a method of adding the diluting water to the raw material ozonated water being forwarded through a closed pipe. [0030] (4) A method set forth in any of the preceding items (1)-(3), wherein the raw material ozonated water has resulted from dissolving ozone in ultra pure water and the diluting water is ultra pure water. [0031] (5) A method set forth in any of the preceding items (1)-(4), wherein the raw material ozonated water and/or the diluting water contain an ozone decomposition inhibiting agent. [0032] (6) A method set forth in the preceding item (5), wherein the ozone decomposition inhibiting agent is at least one member selected from the group consisting of carbon dioxide gas, acidic substances, and organic substances. [0033] The present invention permits efficient use of the ozonated water at the use point with the wasteful decomposition of ozone suppressed. Moreover, since the method resides in diluting the ozonated water of high concentration, the adjustment of the output of the ozonated water producing device can be utilized to the utmost. Further, since the ozonated water of high concentration is diluted, the time spent for the forwarding of the ozonated water can be shortened. [0034] Primarily this invention, in forwarding an ozonated water from an ozonated water producing device to the use point and enabling the use point to be supplied with an ozonated water of a target concentration, concerns a method for forwarding the ozonated water, comprising adding a diluting water to a raw material ozonated water in the neighborhood of the ozonated water producing device under a condition inhibiting exposure to an ambient air, adjusting the ozone concentration to a desired level aimed at the use point, and subsequently guiding the ozonated water through a pipe to the use point. [0035] The present inventors, with a view to learning the effect of dilution of the raw material ozonated water, tried to examine the ozone concentration in a water tank when the ozonated water was supplied to a water tank having an inner volume of 40 L for 10 minutes. To be specific, the ozonated water having an ozone concentration of 28 ppm was delivered at a rate of 4 L/min. over a distance of 30 cm and the ozonated water in the water tank was tested for ozone concentration after the elapse of 10 minutes. For comparison, an ozonated water having an ozone concentration of 56 ppm and ultra pure water were severally delivered each at a rate of 2 L/min. over the same distance for the same duration and the water in the water bath was tested for ozone concentration. The results of these two tests were compared. The ozone concentration was 9 ppm in the former test and 5 ppm in the latter test. This fact clearly indicates that the dilution of the ozonated water of high concentration with the ultra pure water results in promoting the loss of ozone as in the form of decomposition or dissipation of ozone. This allows an inference that the ultra pure water manifests a catalytic action of promoting the effect of decomposing or dissipating the ozone contained in the ozonated water of high concentration, though the mechanism of this catalytic action remains yet to be elucidated. On the basis of these results, the dilution of the ozonated water of high concentration does not prove favorable. [0036] When the study on the dilution with the ultra pure water of high purity was further continued, however, it was found that the loss of the ozone was suppressed by performing the dilution in a closed pipe. During the delivery of the ozonated water over a long distance, a search for the point in the entire length of the water pipe at which the decrease of the concentration of ozone caused by the dilution was smallest revealed as follows. The loss by the decomposition of ozone was smaller when the ozonated water having the highest possible ozone concentration immediately after the production of the ozonated water was diluted and then forwarded to the use point than when the ozonated water of high zone concentration was forwarded to the use point and then diluted. Thus, the results indicate that also in the case of forwarding the ozonated water to a use point which is separated from the ozonated water producing device, the decrease of the concentration of the ozonated water due to the self-decomposition of the dissolved ozone can be suppressed, the loss of the concentration can be minimized, and the ozonated water can be efficiently utilized. Now, the present invention will be explained in detail below. [0037] The ozonated water producing device is only required to be capable of producing ozonated water and the method for producing the ozonated water and the raw material to be used for the production do not need to be particularly restricted. The present invention, however, is characterized by diluting the ozonated water of high concentration and then forwarding it to the use point and is useful where a device capable of producing the ozonated water of high concentration is used. In the meantime, since the inclusion of a step for diluting the ozonated water results in allying the loss due to the decomposition and dissipation of ozone, the ozonated water production device does not need to be restricted on account of the ozone concentration. Generally, the ozone concentration is in the approximate range of 5-200 ppm. [0038] In view of the present state of affairs which adds to the difficulty encountered in the production of ozonated water of high concentration in accordance as the ultra pure water used in cleaning a semiconductor material gains in purity, the present invention is effective when the ultra pure water is used as the raw material for the ozonated water. It is known that particularly in the ultra pure water of high purity, the self-decomposition of the dissolved ozone occurs violently. The present invention is highly effective when it is applied to the ozonated water which results from dissolving ozone in the ultra pure water of high purity. It is, therefore, effective when it is applied to such processes as cleaning and surface treating silicon substrates and other semiconductor materials and liquid crystal panels which require the ozonated water of high cleanliness. [0039] The term “use point” as used in this invention is only required to be a point at which the ozonated water resulting from dilution is put to use. The purpose of the use and the distance between the ozonated water production device and the use point are irrelevant. Since this invention excels in the effect of allaying the loss of the ozone contained in the ozonated water, however, it is capable of manifesting the effect thereof fully satisfactorily when the distance between the ozonated water production device and the use point are long. Generally, the distance between the ozonated water production device and the use point are in the range of 1-20 m. [0040] When the central supply system for ozone is realized in the future, the entire floor or the entire building will be supplied with the water. In that case, it is conceivable that the distance between the ozonated water production device and the use point will exceed 100 m. [0041] The present invention contemplates adding the raw material ozonated water prepared by the ozonated water production device and diluting water together in the neighborhood of the device. The expression “neighborhood of the ozonated water production device” means a point which lies between the ozonated water production device and the use point. This point falls within ½, preferably ⅕, more preferably {fraction (1/10)}, and particularly preferably {fraction (1/40)} of the distance from the ozonated water production device toward the use point. By effecting this dilution on the raw material ozonated water production device side than on the use point side, the loss of the ozone contained in the raw material ozonated water can be prevented more effectively. Further, by effecting this dilution in the initial stage of the long-distance supply and increasing the flow volume thenceforth, it is made possible to shorten the time spent until the use point and allay the amount of the dissolved ozone to be decomposed. Since the ozonated water is decomposed at a rate which increases in accordance as the concentration of the ozonated water increases, the present invention proves advantageous with respect to the ability thereof to suppress the rate of decomposition of ozone. This is done by lowering the ozone concentration during the course of supply. [0042] The dilution of the raw material ozonated water is attained by adding the diluting water to the raw material ozonated water under a condition inhibiting exposure to the ambient air. As a means to make this addition, a method of causing the raw material ozonated water to mix with the diluting water in a closed pipe is available. This method is implemented by introducing the raw material ozonated water supplied from the ozonated water production device into the pipe without being exposed to the ambient air, introducing the diluting water into the pipe via a diluting water mixing port provided in the pipe, and allowing the raw material ozonated water and the diluting water to mix with each other. By precluding the exposure of the raw material ozonated water to the ambient air, the decomposition of the dissolved ozone can be suppressed even when the ozonated water is mixed with the diluting water. [0043] The amount of the diluting water to be added may be decided by taking into due account the loss of the ozone during the supply of the ozonated water until the use point. When the loss of the ozone is totally absent until the use point, the ozonated water concentration after the dilution in the neighborhood of the ozonated water production device may be set at the optimum concentration during the use at the use point. When the occurrence of the loss of α% in the ozonated water is revealed during the course of supply, the ozonated water is only required to have an ozone concentration (100+α)/100 times higher than the ozonated water concentration at the use point while allowing the loss mentioned above. [0044] The present invention does not need to limit the frequency of dilution to one but allows the dilution to be made in a plurality of times. When the ozonated water is forwarded to the use point which are separated from the ozonated water production device, this use point is supplied with the ozonated water of a target concentration. For example, the first diluting water is added to the raw material ozonated water in the neighborhood of the ozonated water production device under a condition inhibiting exposure to the ambient air. This is done to adjust the ozone concentration to a level higher than the target concentration in the neighborhood of the use point. Then the ozonated water is guided through the pipe to the neighborhood of the use point, and the second diluting water is added to the ozonated water to adjust the ozone concentration to the target concentration at the use point. When the loss of ozone of α% is present during the supply of the ozonated water, for example, the ozonated water of a concentration (100+α+β)/100 times higher than the concentration of the ozonated water having a concentration of β% such as, for example, the ozonated water at the use point, is prepared by using the first diluting water and subsequently in the neighborhood of the use point, the ozonated water is adjusted by the addition of the second diluting water to the concentration optimum for actual use. Thus, the adjustment is effected at two stages as described above. By effecting the dilution as divided into a plurality of portions as described above, the ozone concentration at the use point can be adjusted finely and conveniently as well. The expression “neighborhood of the ozonated water production device” means a point which lies between the ozonated water production device and the use point and falls within ½, preferably ⅕, more preferably {fraction (1/10)}, and particularly preferably {fraction (1/40)} of the distance from the ozonated water production device toward the use point. [0045] The present invention conveys the ozonated water by using a pipe. The pipe does not need to be particularly limited by the kind of material used for the pipe and the diameter of the pipe. For the purpose of preventing the ozone from being decomposed or dissipated in consequence of the exposure to the ambient air, the pipe should have a diameter suitable for the amount of the water to be conveyed. The water pipe is preferably furnished with a mechanism which adjusts the feed volumes and the feed rates of the raw material ozonated water and the diluting water. If the flow volume increases during the course of the supply of the water, this increase will possibly result in intensifying the decomposition of the ozonated water on the inner wall of the pipe and the joints in the pipe. [0046] The present invention fully manifests the effect on “the ozonated water resulting from dissolving ozone in ultra pure water of high purity” which is prone to severe ozone decomposition. The raw material ozonated water or the diluting water or both may also contain an added ozone decomposition inhibiting agent. Suitable as the ozone decomposition inhibiting agent usable for this purpose are carbon dioxide gas, acidic substances, and organic substances. [0047] The present invention has the effect thereof enhanced when the raw material ozonated water of high concentration is used as diluted. In principle, however, this effect is manifested without reference to the concentration of the raw material ozonated water. The present invention does not need to restrict the range of concentration of the raw material ozonated water or the ratio of dilution. [0048] The method of the present invention for forwarding the ozonated water contributes to the reduction of the cost of production of the ozonated water. This is because it suppresses the decomposition of ozone by a simple operation, realizes the supply of the ozonated water over a long distance, and allows effective utilization of the ozonated water by lowering the loss thereof by decomposition. [0049] It is, therefore, applied advantageously to the plants for producing semiconductor substrates and liquid crystal panels by consuming ozonated water of adjusted concentration in large amounts, particularly to the cleaning operations. Further, for the sake of increasing the convenience of the use of the ozonated water, the realization of the central supply of the ozonated water has been gaining in importance. This realization necessitates the supply over a long distance. Even in this case, the method of this invention is capable of effectively forwarding the ozonated water. [0050] The method of this invention for forwarding the ozonated water can be utilized not merely in the field of semiconductors but in all the fields which are in need of using the ozonated water. These fields include detergent grade ozonated water for sterilizing and disinfecting foodstuffs and furnishings for medical practices. Also included is wash basin grade ozonated water for sterilizing and disinfecting various articles in numerous fields, for example. BRIEF DESCRIPTION OF THE DRAWINGS [0051] Other objects and features of the present invention will become apparent from the following detailed description considered in connection with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention. [0052] FIG. 1 shows a diagram showing the positions for diluting the ozonated water and the positions for measuring the dissolved ozone concentrations in Examples 1-3; and [0053] FIG. 2 shows a diagram showing the positions for diluting the ozonated water and the positions for measuring the dissolved ozone concentrations in Comparative Examples 1-3. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0054] The present invention will now be described below with reference to the following working examples which are not to be deemed limitative of the present invention in any manner thereof. EXAMPLE 1 [0055] Ozonated water was prepared by using an apparatus illustrated in FIG. 1 . [0056] The raw material ozonated water produced by an ozonated water production device 6 was supplied through a TEFLON® (registered trademark) pipe 3 , {fraction ( 1 / 2 )} inch in inner diameter to a use point 10 . A diluting point 1 was disposed at a position of 0.5 m from the outlet port of the ozonated water production device 6 . At this dilution point 1 , the raw material ozonated water and the ultra pure water 7 for dilution were mixed inside the closed pipe without being exposed to the ambient air. A dissolved ozone concentration meter 2 was disposed at a position 0.5 m farther from the dilution point 1 and a dissolved ozone concentration meter 4 was disposed at a position 10 m farther from the dissolved ozone concentration meter 2 . Between the dissolved ozone concentration meter 2 and the dissolved ozone concentration meter 4 , a TEFLON® (registered trademark) pipe 3 of {fraction (1/2)} inch in diameter was used for forwarding the ozonated water. [0057] As the raw material ozonated water to be supplied, the solution of ozone in ultra pure water containing not more than 1 ppb of TOC was used. The flow rate of the raw material ozonated water was fixed at 2 L/min. Three flow rates, 2 L/min. (dilution to twice the original volume), 4 L/min. (dilution to three times the original volume), and 6 L/min. (dilution to four times the original volume) were used for the diluting ultra pure water. The raw material ozonated water and the diluting ultra pure water were both used at a fixed temperature of 25° C. The dissolved ozone concentrations were measured with the dissolved ozone concentration meter 2 (former stage ozone concentration) and the dissolved ozone concentration meter 4 (latter stage ozone concentration). The results are shown in Table 2. COMPARATIVE EXAMPLE 1 [0058] Ozonated water was prepared by using an apparatus illustrated in FIG. 2 . [0059] The raw material ozonated water produced by an ozonated water production device 6 was supplied through a TEFLON® pipe 3 , {fraction ( 1 / 2 )} inch in inside diameter to a use point 10 . A dilution point 5 was disposed at a position 10.5 m from the outlet port of the ozonated water production device 6 . At the dilution point 5 , the raw material ozone water and the ultra pure water 7 for dilution were mixed in the closed pipe without being exposed to the ambient air. A dissolved ozone concentration meter 2 was disposed at a position of 1 m from the outlet port of the ozonated water production device 6 and a dissolved ozone concentration meter 4 was disposed 0.5 m farther from the dilution point 5 mentioned above. [0060] The dissolved ozone concentrations were measured with the dissolved ozone concentration meter 2 and the dissolved ozone concentration meter 4 by following the procedure of Example 1 while mixing the raw material ozonated water at the dilution point 5 with the ultra pure water for dilution. The results are shown in Table 2. TABLE 2 Example 1 Comparative Example 1 Former-stage Latter-stage Former-stage Latter-stage ozone ozone ozone ozone concentration, concentration, concentration, concentration, ppm ppm ppm ppm No dilution 46 23 46 23 Dilution to 22 19 46 12 twice the original volume Dilution to 15 13 46 8 three times the original volume Dilution to 12 10 46 6 four times the original volume [0061] Comparison of Example 1 and Comparative Example 1 reveals that in the absence of dilution, while the concentrations of the raw material ozonated water (former-stage ozone concentrations) were 46 ppm, those at the use point (later-stage ozone concentrations) both fell to 23 ppm. [0062] In contrast, in the dilutions to 2-4 times the original volume, the ozone concentrations at the use points varied with the positions of dilution. The ozone concentrations obtained in Example 1 in which the dilution was made in the neighborhood of the ozonated water production device were higher than the ozone concentrations obtained in Comparative Example 1 in which the dilution was made in the neighborhood of the use point. EXAMPLE 2 [0063] The supply of the ozonated water was carried out by following the procedure of Example 1 while using ozonated water prepared by dissolving carbon dioxide as an ozone decomposition inhibiting agent to pH 4.7 in ultra pure water having TOC lowered to 1 ppb by irradiation of the ultraviolet light. The results are shown in Table 3. COMPARATIVE EXAMPLE 2 [0064] The supply of the ozonated water was carried out by following the procedure of Comparative Example 1 while using ozonated water prepared by dissolving carbon dioxide as an ozone decomposition inhibiting agent to pH 4.7 in ultra pure water having TOC lowered to 1 ppb by irradiation of the ultraviolet light. The results are shown in Table 3. TABLE 3 Example 2 Comparative Example 2 Former-stage Latter-stage Former-stage Latter-stage ozone ozone ozone ozone concentration, concentration, concentration, concentration, ppm ppm ppm ppm No dilution 127 116 127 116 Dilution to 63 61 127 57 twice the original volume Dilution to 42 41 127 38 three times the original volume Dilution to 32 31 127 28 four times the original volume [0065] Comparison of Example 2 and Comparative Example 2 reveals that in the absence of dilution, while the concentrations of the raw material ozonated water (former-stage ozone concentrations) were 127 ppm, those at the use point (later-stage ozone concentrations) both fell to 116 ppm. [0066] In contrast, in the dilutions to 2-4 times the original volume, the ozone concentrations at the use points varied with the positions of dilution. The ozone concentrations obtained in Example 2 in which the dilution was made in the neighborhood of the ozonated water production device were higher than the ozone concentrations obtained in Comparative Example 2 in which the dilution was made in the neighborhood of the use point. EXAMPLE 3 [0067] The supply of the ozonated water was carried out by following the procedure of Example 1 while using ozonated water prepared by dissolving isopropyl alcohol as an ozone decomposition inhibiting agent in a concentration of 1.5 ppm in ultra pure water having TOC lowered to 1 ppb by irradiation of the ultraviolet light. The results are shown in Table 4. COMPARATIVE EXAMPLE 3 [0068] The supply of the ozonated water was carried out by following the procedure of Comparative Example 1 while using ozonated water prepared by dissolving isopropyl alcohol as an ozone decomposition inhibiting agent in a concentration of 1.5 ppm in ultra pure water having TOC lowered to 1 ppb by irradiation of the ultraviolet light. The results are shown in Table 4. TABLE 4 Example 3 Comparative Example 3 Former-stage Latter-stage Former-stage Latter-stage ozone ozone ozone ozone concentration, concentration, concentration, concentration, ppm ppm ppm ppm No dilution 141 126 141 126 Dilution to 71 69 141 60 twice the original volume Dilution to 47 46 141 40 three times the original volume Dilution to 35 35 141 31 four times the original volume Comparison of Example 3 and Comparative Example 3 reveals that in the absence of dilution, while the concentrations of the raw material ozonated water (former-stage ozone concentrations) were 141 ppm, those at the use point (later-stage ozone concentrations) both fell to 126 ppm. [0069] In contrast, in the dilutions to 2-4 times the original volume, the ozone concentrations at the use points varied with the positions of dilution. The ozone concentrations obtained in Example 3 in which the dilution was made in the neighborhood of the ozonated water production device were higher than the ozone concentrations obtained in Comparative Example 3 in which the dilution was made in the neighborhood of the use point. [0070] According to the method of the present invention for forwarding an ozonated water, in the case of forwarding the ozonated water over a long distance and enabling the use point to be supplied with the ozonated water having an adjusted concentration, a simple operation of adding the diluting water to the ozonated water immediately after production, guiding the resultant ozonated water through a pipe to the use point, and adjusting the amount of the diluting water to be added so as to enable the ozonated water to acquire a target concentration at the use point results in suppressing the decomposition of ozone, permitting the supply of the ozonated water over the long distance, lowering the loss of the ozonated water by decomposition, and allowing effective use of the ozonated water. Thus, the method of the present invention contributes to the reduction of the cost of production of the ozonated water. [0071] The method of the present invention for forwarding the ozonated water, therefore, is applied advantageously to the plants for producing semiconductor substrates and liquid crystal panels by consuming ozonated water of adjusted concentration in large amounts, particularly to the cleaning operations. [0072] Further, for the sake of increasing the convenience of the use of the ozonated water in the future, the realization of the central supply of the ozonated water has been gaining in importance. This realization necessitates the supply over a long distance. Even in this case, the method of this invention is capable of effectively forwarding the ozonated water. [0073] The method of the present invention for forwarding the ozonated water can be utilized not merely in the field of semiconductors mentioned above by way of an example but in all the fields which are in need of using the ozonated water. These fields include detergent grade ozonated water for sterilizing and disinfecting foodstuffs and furnishings for medical practices and wash basin grade ozonated water for sterilizing and disinfecting various articles in numerous fields, for example. Explanation of Reference Numberals [0000] 1 . Dilution point 2 . Dissolved ozone concentration meter 3 . TEFLON® (registered trademark) pipe {fraction (1/2)} inch in diameter 4 . Ozone concentration meter 5 . Dilution point 6 . Ozonated water production device 7 . Ultra pure water 10 . Use point [0082] Accordingly, while only a few embodiments of the present invention have been shown and described, it is obvious that many changes and modifications may be made thereunto without departing from the spirit and scope of the invention.

1a

TECHNICAL FIELD The present invention pertains to devices, systems, and methods for planting seeds, as well as to methods of manufacturing such devices and systems. More particularly, the present invention is directed to: a) devices comprising a storage container, an air propulsion apparatus, and a hollow horizontal member and a plurality of hollow vertical members; b) systems comprising a storage container, an air propulsion apparatus, and a hollow horizontal member and a plurality of hollow vertical members; and c) methods of manufacturing or using such devices and systems. BACKGROUND OF THE INVENTION In rural areas of the developing world, many people remain mired in poverty and dependent upon small subsistence level farms as their only source of food. These subsistence farmers, reliant on their harvests to feed themselves and their families, lack the agricultural equipment needed to increase the productivity of their harvests. The low productivity of these subsistence farms means that farmers are unable to grow any surplus of food that could be sold at the market place, preventing these farmers from earning the income that would allow them to invest in their farms, purchase healthcare and education for their families, and progress out of poverty towards the middle class. Cambodia, one of the poorest countries in Asia, presents a vivid illustration of the plight faced by Third World subsistence farmers. Plagued by decades of conflict, nearly eighty percent of Cambodia's population lives in rural areas, with many relying on farming as their only source of food and income. Rice is the primary crop of Cambodian farmers. To ensure the optimal spacing of the rice plants and to facilitate weeding and the application of fertilizers, herbicides, or insecticide, rice is grown in rows, which results in greater crop yields for the rice than growing the crop in other patterns. In a traditional Cambodian method for rice-farming, farmers plant rice in one or more smaller plots for a certain period of time, and then transplant the seedlings by hand to the main field for maturation once those seedlings have grown to a sufficient size. In contrast, in more developed countries where farming is more machine-intensive and industrialized, automated equipment capable of mechanically planting and cultivating rice in rows is commonly utilized, replacing the traditional hand-transplantation techniques used by rural farmers in Cambodia and other Southeast Asian countries. Unlike the more industrialized farming sectors in other nations, the relative lack of income and resources of many Cambodian farmers means that automated equipment for planting rice crops is largely unavailable to these farmers. This means that these farmers must employ human labor to plant their rice crops using the traditional Cambodian method. This method is very labor intensive, as the traditional method can take up to fifty days for a single farmer to plant a one-hectare field of rice. And recent years have seen a migration of working aged men and women from rural Cambodian farming communities to more urban locales in order to work in garment factories or construction in Cambodia or in other Southeast Asian countries. This migration has reduced the amount of labor available to these Cambodian communities, forcing farmers in Cambodia to either plant fewer fields of rice or use less efficient methods for planting rice (such as spreading rice seeds by hand on dry ground, which results in sub-optimal arrangements of the rice crop and many of the seeds being eaten by animals or failing to sprout). The resulting reduction in crop yields negatively impacts Cambodian farm families, who already struggle to satisfy their nutritional needs (and to meet their needs for adequate healthcare and education). To solve these challenges faced by Cambodian farmers, as well as farmers in other Southeast Asian rice-planting countries, there remains a need for the development and distribution of devices and techniques that would enable these farmers to plant rows of crops while reducing the time, labor, costs, and overall resources needed to plant their crops. Such devices and techniques would allow these farmers to employ their labor more efficiently and waste less seed, water, and fertilizer in the planting process, not only improving crop yields, but also providing an opportunity for these farmers to allocate more of their time elsewhere (for example, obtaining education). These devices and techniques would ultimately aid in raising the income of farmers, helping to lift them and their families out of poverty. While devices for planting rice seeds exist, no known existing designs are sufficient to meet the above-mentioned needs of farmers in Cambodia or other Southeast Asian nations. While sophisticated devices for planting rice seed exist and are used in more industrialized nations, such mechanized devices are too expensive and complex for small-scale farmers. Furthermore, for example, Cambodia's manufacturing sector is relatively less-developed in comparison with some neighboring countries. Therefore, for a device for planting rice to be truly accessible to Cambodian farmers (or rural farmers in other Southeast Asian countries) at a reasonable cost, that device must be capable of being manufactured locally, using readily available materials and manufacturing processes. Simpler devices, such as broadcast planters that use air power to spray seeds, are inefficient, blowing rice seed in uncontrolled patterns and lacking the concentrated velocity necessary to embed the rice seed into the soil. If not embedded into the soil, the rice remains on top of the soil, and is readily eaten by animals or blown away by wind or washed away by rains. Drum seeders, which are rolled on the ground and drop seed out of holes, also cannot embed the dropped rice seeds into soil, similarly leaving the rice susceptible to being eaten or swept away by wind or rain. Other attempts at developing a suitable device for planting rice seeds suffered from repeated jamming problems, causing these attempts to fail. As discussed above, existing devices and techniques for planting rice seed suffer from deficiencies: failing to effectively plant rice seed in rows without unduly wasting seed, labor, and other resources. As a result, there remains a need for devices and techniques for planting rice seeds that do not suffer from the drawbacks shared by these existing devices and methods. SUMMARY OF THE INVENTION The present invention is directed, in certain embodiments, to devices for planting seeds, the devices comprising a storage container, an air propulsion apparatus connected to the storage container, a first hollow member, a hollow horizontal member connected to the first hollow member, and a plurality of hollow vertical members connected to a bottom of the hollow horizontal member. In certain embodiments, the storage container contains seeds. In certain further embodiments, the storage container is capable of holding at least 10 kilograms of seeds. In still further embodiments, the storage container is capable of holding at least 20 kilograms of seeds. In certain embodiments, the air propulsion apparatus is connected to the hollow horizontal member via the first hollow member. In certain embodiments, the first hollow member is a hose. In certain embodiments, the air propulsion apparatus is a broadcast planter. In certain further embodiments, the broadcast planter is a gasoline-powered broadcast planter. In other further embodiments, the broadcast planter is an electric-powered broadcast planter. In still further embodiments, the electric-powered broadcast planter comprises a battery. In certain embodiments, the hollow horizontal member comprises a plurality of pipes and flow reducers connected by T-connectors. In certain further embodiments, the device further comprises elbow connectors connected to a first and a second end of the hollow horizontal member, and a flow reducer connected to each of the elbow connectors. In still further embodiments, the plurality of pipes, flow reducers, T-connectors, and elbow connectors are comprised of PVC. In certain embodiments, a diameter of the hollow horizontal member at a center of the hollow horizontal member is greater than both: a) a diameter of the hollow horizontal member at a first end of the hollow horizontal member; and b) a diameter of the hollow horizontal member at a second end of the hollow horizontal member. In certain further embodiments, the diameter of the hollow horizontal member at the first end is equal to the diameter of the hollow horizontal member at the second end. In certain embodiments, a diameter of the hollow horizontal member at a center of the hollow horizontal member is equal to both: a) a diameter of the hollow horizontal member at a first end of the hollow horizontal member; and b) a diameter of the hollow horizontal member at a second end of the hollow horizontal member. In certain embodiments, the first hollow member is connected to the hollow horizontal member by a T-connector at a center of the hollow horizontal member. In certain further embodiments, the first hollow member is connected to the hollow horizontal member at a top of the hollow horizontal member. In certain embodiments, the T-connector comprises a protrusion that divides a perpendicular inlet of the T-connector in half. In certain further embodiments, the protrusion comprises a sheet of material. In certain embodiments, each of the plurality of hollow vertical members is connected to the bottom of the hollow horizontal member by either a T-connector or an elbow connector. In certain further embodiments, each of the plurality of hollow vertical members comprises a PVC pipe. In certain embodiments, a diameter of a first end of each of the plurality of hollow vertical members is larger than a diameter of a second end of each of the plurality of hollow vertical members. In certain further embodiments, the diameter of the first end of each of the plurality of hollow vertical members is equal to or lesser than a diameter of a midpoint of each of the plurality of hollow vertical members. In still further embodiments, the first end of each of the plurality of hollow vertical members is located within the T-connector or elbow connector connecting the hollow vertical member to the hollow horizontal member. In certain embodiments, the first end of the at least one of the plurality of hollow vertical members comprises a baffle. In certain further embodiments, the first end of the at least one hollow vertical member comprises a notch. In still further embodiments, a diameter of the first end of the at least one hollow vertical member above the notch is smaller than a diameter of the first end of the at least one hollow vertical member below the notch. In even further embodiments, the hollow horizontal member is engaged with the notch in the first end of the at least one hollow vertical member. In certain embodiments, the second end of each of the plurality of hollow vertical members comprises a nozzle. In further embodiments, the second end of each of the plurality of hollow vertical members further comprises a nozzle cover. In still further embodiments, the nozzle cover comprises a flexible hose. In certain embodiments, the plurality of hollow vertical members comprises between 4 hollow vertical members and 40 hollow vertical members. In certain further embodiments, the plurality of hollow vertical members comprises between 10 hollow vertical members and 30 hollow vertical members. In still further embodiments, the plurality of hollow vertical members comprises between 14 hollow vertical members and 18 hollow vertical members. In other further embodiments, the plurality of vertical members comprises between 22 hollow vertical members and 26 hollow vertical members. In certain embodiments, the plurality of hollow vertical members are evenly spaced along the hollow horizontal member. The present invention is directed, in certain embodiments, to systems for planting seeds, the systems comprising a storage container, an air propulsion apparatus connected to the storage container, a first hollow member, a hollow horizontal member connected to the first hollow member, and a plurality of hollow vertical members connected to a bottom of the hollow horizontal member. In certain embodiments, at least one of the storage container, the air propulsion apparatus, the first hollow member, the hollow horizontal member, and the plurality of hollow vertical members is mounted on a movable support. In certain further embodiments, the movable support comprises a cart. In still further embodiments, the cart comprises wheels or skis. In even further embodiments, the cart is human-powered, animal-powered, or machine-powered. In certain embodiments, the moveable support is covered with a rust-resistant coating. In certain embodiments, at least one of the storage container, the air propulsion apparatus, the first hollow member, the hollow horizontal member, and the plurality of hollow vertical members is carried by a human user. The present invention is directed, in certain embodiments, to methods for planting seeds, the methods comprising the steps of filling a storage container with seeds, emptying the seeds from the storage container into an air propulsion apparatus, and propelling the seeds through the air propulsion apparatus, through a first hollow member, through a horizontal hollow member, through a plurality of vertical hollow members, and into the ground. In certain embodiments, the methods comprise the step of soaking the seeds in water for a period of time and then drying the seeds before filling the storage container with the seeds. In certain embodiments, a first end of at least one of the plurality of vertical hollow members comprises a baffle located inside the hollow horizontal member, and an equal volume of seeds is propelled into each of the plurality of vertical horizontal members. In certain further embodiments, a second end of each of the plurality of vertical hollow members comprises a nozzle, and the velocity of the seeds exiting the nozzle of the vertical hollow member is greater than or equal to the velocity of the seeds entering the first end of the vertical hollow member. In certain embodiments, filling the storage container with seeds comprises filling the storage container with both seeds and fertilizer. In certain further embodiments, the fertilizer mixes with the seeds to create a mixture of seeds and fertilizer, and the mixture empties from the storage container into the air propulsion apparatus, which propels the mixture through the air propulsion apparatus, through the first hollow member, through the horizontal hollow member, and through the plurality of vertical hollow members and into the ground. The present invention is directed, in certain embodiments, to methods of manufacturing devices for planting seeds, the methods comprising the steps of thermal forming a T-connector from PVC, thermal forming a sheet of PVC, inserting the sheet of PVC into the T-connector to form a flow divider, resizing a plurality of PVC pipes, flow reducers, T-connectors, and elbow connectors and gluing the plurality of PVC pipes, flow reducers, T-connectors, and elbow connectors together to form a hollow horizontal member, connecting a storage container to a first hollow member via an air propulsion apparatus, connecting the hollow horizontal member to the first hollow member via the flow divider, thermal die forming a first end of at least one of a plurality of vertical hollow members to form a baffle, thermal die forming a second end of each of the plurality of vertical hollow members to form a nozzle, and inserting the first end of each of the plurality of vertical hollow members into a bottom of the hollow horizontal member. In certain embodiments, the step of resizing the plurality of PVC pipes, flow reducers, T-connectors, and elbow connectors comprises cutting and grinding the plurality of PVC pipes, flow reducers, T-connectors, and elbow connectors. In certain embodiments, the methods further comprise the step of covering the horizontal hollow member and the plurality of vertical hollow members with a UV-resistant coating. In certain embodiments, the methods further comprise the step of enclosing the hollow horizontal member with a PVC pipe with an inner diameter less than or equal to an outer diameter of the hollow horizontal member. In certain further embodiments, enclosing the hollow horizontal member with the PVC pipe comprises cutting a slit in a bottom of the PVC pipe and stretching the PVC pipe to enclose the hollow horizontal member. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 depicts a perspective view of an exemplary device for planting seeds, the device comprising a storage container, an air propulsion apparatus, and a first hollow member, hollow horizontal member, and plurality of hollow vertical members. FIG. 2 depicts a perspective view of the device for planting seeds of FIG. 1 , the device being mounted on a cart that comprises wheels. FIG. 3 depicts a perspective view of the device for planting seeds of FIG. 1 , the device being mounted on a cart that comprises skis. FIG. 4A depicts a perspective view of the hollow horizontal member and plurality of hollow vertical members of FIG. 1 . FIG. 4B depicts a front view of the hollow horizontal member and plurality of hollow vertical members of FIG. 1 . FIG. 4C depicts a side view of the hollow horizontal member and plurality of hollow vertical members of FIG. 1 . FIG. 4D depicts a top view of the hollow horizontal member and plurality of hollow vertical members of FIG. 1 . FIG. 4E depicts a bottom view of the hollow horizontal member and plurality of hollow vertical members of FIG. 1 . FIG. 5 depicts an interior cross-sectional view of the hollow horizontal member and the plurality of hollow vertical members of FIGS. 4A-4E . FIG. 6A depicts a perspective view of one of the hollow vertical members depicted in FIGS. 4A-4E . FIG. 6B depicts a front view of one of the hollow vertical members depicted in FIGS. 4A-4E . FIG. 6C depicts a side view of one of the hollow vertical members depicted in FIGS. 4A-4E . FIG. 6D depicts a top view of one of the hollow vertical members depicted in FIGS. 4A-4E . FIG. 6E depicts a bottom view of one of the hollow vertical members depicted in FIGS. 4A-4E . FIG. 7 depicts a perspective view of the exemplary hollow vertical member depicted in FIGS. 6A-6E , the hollow vertical member further comprising a nozzle cover. FIG. 8 depicts a perspective view of an exemplary device for planting seeds that comprises a frame for mounting and supporting a plurality of hollow vertical members, handles, and a pair of skis mounted to the frame. DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to air-powered devices for planting seeds, systems incorporating those air-powered devices, as well as to methods of operating and manufacturing such devices and systems for planting seeds. One embodiment of the invention is a device for planting seeds, comprising a storage container, an air propulsion apparatus, a first hollow member, a hollow horizontal member, and a plurality of hollow vertical members. The storage container is connected to the air propulsion apparatus, which uses air propulsion to propel seeds throughout the hollow members of the device and into the ground to be planted. A second embodiment of the invention is a system for planting seeds. The system incorporates the air-powered device, and at least a portion of the device is mounted on a movable support or carried by a human user. A third embodiment of the invention is a method of planting seeds, comprising filling the storage container with seeds, emptying the seeds from the storage container into the air propulsion apparatus, and using air power from the air propulsion apparatus to propel seeds throughout the hollow members of the device and into the ground to be planted. A fourth embodiment of the invention is a method for manufacturing the air-powered device for planting seeds, comprising thermal forming a flow divider from PVC, resizing and gluing together a plurality of PVC pipes, flow reducers, T-connectors, and elbow connectors to form a hollow horizontal member, thermal die forming a plurality of vertical hollow members, and connecting together the storage container, air propulsion apparatus, hollow horizontal member, and the plurality of vertical hollow members to prepare the air-powered device for planting seeds. FIG. 1 depicts an exemplary embodiment of a device 100 for planting seeds, in accordance with the present invention. The device 100 comprises a storage container 102 capable of storing seeds and then releasing those seeds into the device 100 during the planting process. In these embodiments, the storage container 102 holds seeds, fertilizer, or a mixture of both seed and fertilizer. In some embodiments, the storage container 102 contains rice seeds. However, the type of seed stored in the storage container 102 is not limited to rice seeds—the storage container 102 may instead contain (for example) seed for corn, mung beans, soy beans, or other types of grains or legumes. In embodiments, the storage container 102 is comprised of plastic. However, the storage container 102 may be composed of other materials as well: for example, metals such as steel and/or aluminum, other polymers (such as PVC), or even wood. In certain embodiments of the invention, such as the storage container 102 depicted in the device 100 of FIG. 1 , the storage container 102 is a hopper 102 that is integrated into an air propulsion device 104 , such as a hopper 102 that feeds into a broadcast planter 104 . In other embodiments, however, the storage container 102 may be separate from the air propulsion device. In these various embodiments, the storage container 102 may be a hopper, a tub, a basket, or similar storage containers 102 . The storage container 102 may be cylindrical, square, rectangular, or any other shape suitable for holding seed, fertilizer, and other materials used in the planting process. In embodiments of the present invention, the storage container 102 has sufficient size and strength to be capable of holding at least 10 kilograms of seeds and/or fertilizer. In some of these embodiments of the present invention, the storage container 102 possesses sufficient size and strength to be capable of holding at least 10 kilograms of seeds (and/or fertilizer). Further, in some of these various embodiments, the storage container 102 is of sufficient size and strength to house at least 15, at least 20, at least 25, or at least 30 kilograms of seeds (and/or fertilizer). The storage containers 102 of the present invention will be capable of holding a varying amount of seeds depending upon the dimensions of the storage container 102 , the type of seeds (and their size) placed in the storage container 102 , whether the seeds were enlarged by soaking them overnight in water before planting, and other considerations. As discussed above, the seeds in storage container 102 may have been soaked, and then dried, before the storage container 102 was filled with those seeds. Soaking the seeds enables the seeds to more efficiently embed in the ground and to germinate at a faster rate. If the seeds are not soaked before planting, they may be more susceptible to being blown away in strong winds, or being eaten by animals, before they embed in the ground and germinate. In addition to storage container 102 , the device 100 for planting seeds in a field comprises an air propulsion apparatus 104 connected to the storage container 102 . In preferred embodiments of the present invention, the device 100 for planting seeds in a field comprises an air propulsion apparatus 104 . In certain preferred embodiments of the invention, the air propulsion apparatus 104 is a broadcast planter 104 (also known as a broadcast seeder, a seed blower, or a broadcast seed blower). The broadcast planter 104 is an agricultural device commonly used to spread seed, fertilizer, and other substances as well (such as, for example, mulch, lime, salt, or other granular products). Suitable fertilizers for use with broadcast planter 104 include, for example, NPK 18-46-0, NPK 15-15-15, NPK 16-20, or NPK 46. The broadcast planter 104 operates by feeding seeds or fertilizer from a hopper 102 at a controlled rate into an air-powered seed blower, which projects the seeds out of the seed blower by spraying them using air power. In some embodiments of the present invention, the seed blower of the broadcast planter 104 is gasoline- or diesel-powered. However, in other embodiments of the invention, the seed blower of the broadcast planter 104 is electric-powered, and can comprise, for example, a rechargeable battery which may be recharged from electricity from solar power, wind power, or other renewable energy sources. Instead of a broadcast planter 104 , however, the air propulsion apparatus 104 could also comprise, for example, a leaf blower. In preferred embodiments of the invention, the device 100 for planting seeds comprises a hollow member 106 connected to the air propulsion apparatus 104 . In these embodiments, the seeds (and/or fertilizer, or mulch, or other granular material) are propelled into (and through) the hollow member 106 by the air propulsion apparatus 104 , and the hollow member 106 serves to connect the seed storage container 102 and air propulsion apparatus 104 to the rest of the device 100 for planting seeds. In certain embodiments, the hollow member 106 attached to the air propulsion apparatus 104 may be a flexible hollow member 106 , such as the hose 106 depicted in FIG. 1 . In these embodiments, the hollow member 106 may comprise a hose 106 (either a corrugated or non-corrugated hose), composed of (for example) a rubber or a flexible polymer. In other embodiments, however, the hollow member 106 attached to the air propulsion apparatus 104 may be made of a rigid material, such as (for example) PVC pipe, aluminum, steel, or other suitable materials. In these embodiments, the hollow member 106 may be a rigid cylindrical tube, for example, instead of a flexible hose. As shown in the device 100 depicted in FIG. 1 , while one end of flexible hollow member 106 is connected to air propulsion apparatus 104 , the other end of flexible hollow member 106 is connected to a horizontal member 110 , into which the seeds from storage container 102 are propelled from broadcast planter 104 and through flexible hollow member 106 into horizontal member 110 . The device 100 also comprises a plurality of vertical members 120 , which are each attached to a bottom of horizontal member 110 . The seeds propelled into hollow horizontal member 110 are propelled through the hollow horizontal member 110 towards the ends of hollow horizontal member 110 and into the plurality of hollow vertical members 120 , and from the ends of the vertical members 120 into the ground for planting. In various embodiments of the device 100 depicted in FIG. 1 , the number of vertical members 120 that are attached to hollow horizontal member 110 may vary, based on, for example, the size of hollow horizontal member 110 , and/or the type (and power) of the air propulsion apparatus 104 . In some preferred embodiments, the device 100 comprises an equal number of vertical members 120 on each side of the point where flexible hollow member 106 connects to hollow horizontal member 110 , the distances between each pair of adjacent vertical members 120 are constant and equal, and the device 100 is configured so that an equal amount of seed is propelled through each individual one of the plurality of vertical members 120 . In these embodiments, the device 100 will have an even number of vertical members 120 . An equal amount of seed being propelled through each one of the plurality of vertical members 120 allows a farmer to plant even, equidistantly spaced rows of crops, which each row containing a relatively equal number of plants. In other embodiments, however, the number of vertical members 120 on each side of the point where flexible hollow member 106 connects to hollow horizontal member 110 may be different. In various embodiments of the present invention, the plurality of hollow vertical members 120 can comprise between 4 and 40 hollow vertical members, between 10 and 30 hollow vertical members, between 22 and 26 hollow members, or between 14 and 18 hollow vertical members. The relative amounts of seed propelled through each of the plurality of vertical members 120 can be tested by running the device 100 in an experimental environment, and measuring the amount of seed that is propelled through each of the plurality of vertical members 120 by placing a bag or sock over the end of each of the plurality of vertical members 120 , and then comparing the relative amount of seed that has been collected in each bag or sock. In the exemplary embodiment depicted in FIG. 1 , the air propulsion apparatus 104 can be carried by a user of the device 100 , for example by mounting the storage container 102 and air propulsion apparatus 104 on a backpack (not shown) or other equipment that can be carried by a user. In these embodiments, one user may carry the storage container 102 and air propulsion apparatus 104 around a field using a backpack or similar equipment, and one or more other users may aid in moving the horizontal member 110 and vertical members 120 around the field during the planting process. FIG. 2 depicts a different embodiment of a system 200 for planting seeds, in which the storage container 102 , air propulsion apparatus 104 , horizontal member 110 , and vertical members 120 are mounted on a moveable support 210 . In this exemplary system 200 , the moveable support 210 is a cart 210 with wheels 220 —however, the moveable support could take other forms as well (for example, a sled). In system 200 , the cart 210 helps bear the weight of the storage container 102 , air propulsion apparatus 104 , horizontal member 110 , and vertical members 120 , and wheels 220 aid a user of system 200 of moving the system 200 around a field to plant seeds using system 200 . The cart 210 and wheels 220 may be made of metals (such as iron, steel, stainless steel, or aluminum), or other materials such as PVC, bamboo, or wood, (or, in the case of the wheels, rubber) and may be coated with one or more substances that protect the cart 210 from rust and/or degradation from ultraviolet (UV) rays (such as rust- and/or UV-resistant paint(s)). In some embodiments, part of the system 200 may be mounted on cart 210 and wheeled (or otherwise moved) by a first user, and a separate part of the system 200 may be carried around the field separately by one or more other users. In other exemplary embodiments, however, the cart 210 may be towed by an animal, or may have a motor or other propulsion device capable of mechanically propelling cart 210 with little or no effort from a user. The wheels 220 of cart 210 are useful in moving system 200 around a field in which the ground is relatively firm. However, if the field is inundated with water or relatively muddy (as rice paddies commonly are), the wheels 220 of cart 210 may become bogged down in mud or water, making it difficult to move system 200 around the field. FIG. 3 depicts a different exemplary system 300 , featuring a cart 310 with two skis 320 upon which the cart 310 is mounted. The skis 320 are preferred in wetter environments, such as an inundated rice paddy, in which it is easier for the system 300 to slide over the ground of a field instead of using rolling wheels that can become bogged down in the wet ground, such as the wheels 220 of the cart 210 shown in FIG. 2 . The skis 320 of system 300 may be made of different materials, for example a rigid plastic (such as PVC plastic) or other polymers, a metal (such as steel or aluminum), or composite materials. FIGS. 4A-E depicts an exemplary embodiment of the “piping” system 400 that comprises both the hollow horizontal member and vertical members of a device for planting seeds. In this exemplary embodiment, the piping system 400 attaches to a flexible hollow member (such as hollow member 106 depicted in FIG. 1 ) via a T-connector 420 . The T-connector 420 receives seeds from an air propulsion device (not shown), such as a broadcast planter, and distributes the seeds evenly to each side of the T-connector 420 by utilizing a “flow divider” inside the T-connector 420 which splits the flow of seeds. The flow divider (not shown in this view) may be a flat, planar sheet of material, which splits the volume inside the perpendicular inlet of the T-connector 420 in half. The T-connector 420 may be positioned so that the flexible hollow member is attached to the top of the hollow horizontal member, to the side of the hollow horizontal member, or at an angle in-between. In exemplary preferred embodiments, T-connector 420 and the flow divider inside are both comprised of polyvinyl chloride (PVC) plastic. The T-connector 420 and the flow divider may be manufactured by thermal forming the T-connector 420 from PVC, thermal forming a sheet of PVC, and then inserting the thermal-formed sheet of PVC into the perpendicular inlet of the T-connector 420 to form a flow divider within that perpendicular inlet. The hollow horizontal member of piping system 400 is comprised of a number of T-connectors 440 and flow reducers 460 that connect segments of pipe 430 to form the hollow horizontal member. The T-connectors 440 connect both the segments of pipe 430 with each other, and also connect the vertical members 410 to the hollow horizontal member. In the exemplary preferred embodiment 400 depicted in FIGS. 4A-E , the segments of pipe 430 decrease in diameter along the length of hollow horizontal member away from T-connector 420 towards the ends of the hollow horizontal member, because the amount of seed flowing through the segments of pipe 430 decreases at increasing distances from the receiving T-connector 420 as seed is directed into each of vertical members 410 . The flow reducers 460 connect segments of pipe 430 of different diameters, allowing the hollow horizontal member to decrease in diameter so that a diameter of the hollow horizontal member is greater at the T-connector 420 than either of the two ends of the hollow horizontal member, which each comprise elbow connectors 450 which connect the end vertical members 410 to the hollow horizontal member. The segments of pipe 430 , the T-connectors 420 and 440 , and the flow reducers 460 may be comprised of varying materials, such as metals, polymers, or composites. However, in exemplary preferred embodiments of the piping system 400 , the segments of pipe 430 , the T-connectors 420 and 440 , and the flow reducers 460 are all comprised of polyvinyl chloride (PVC) plastic. In exemplary embodiments, the segments of pipe 430 , the T-connectors 420 and 440 , and the flow reducers 460 are resized and then connected together to form the horizontal hollow member of system 400 . Resizing includes, for example, cutting, grinding, and using other machining techniques to resize the segments of pipe 430 , the T-connectors 420 and 440 , and the flow reducers 460 . After the segments of pipe 430 , the T-connectors 420 and 440 , and the flow reducers 460 are connected together, they can be glued together to form the hollow horizontal member. While the hollow horizontal member of exemplary embodiment 400 is comprised of a plurality of interconnected segments of pipe 430 , T-connectors 420 and 440 , and flow reducers 460 as described above, in other embodiments of the invention, the hollow horizontal member may comprise a single hollow horizontal component (not shown). In these embodiments, the single hollow horizontal component may be a tube, pipe, or cylinder. In certain embodiments, the single hollow horizontal component has a constant diameter along its length. In other embodiments, the ends of the hollow horizontal component each have a smaller diameter than the center of the hollow horizontal component. In the exemplary embodiment 400 depicted in FIGS. 4A-E , the piping 400 comprises sixteen vertical members 410 , with eight vertical members 410 evenly spaced along each side of the T-connector 420 . In this exemplary embodiment, an equal amount of seed is directed into each of the eight vertical members 410 . In exemplary piping system 400 , of the vertical members 410 decreases in diameter from the top of the vertical member 410 to the bottom of the vertical member 410 , forming a nozzle 415 at the end of vertical member 410 . The nozzle 415 increases the velocity of seeds being propelled from vertical member 410 (as the cross-sectional area of nozzle 415 is smaller in comparison to the upper part of vertical member 410 ), and also focuses the area in which seeds are propelled from vertical member 410 , allowing seeds to effectively embed into the ground of a field in neat, equidistant rows. In some embodiments, the diameter of the vertical member 410 may remain constant along the majority of the vertical length of vertical member 410 , only decreasing at the portion of vertical member 410 that comprises nozzle 415 . In other embodiments, the diameter of the vertical member 410 may vary along the entire vertical length of vertical member 410 , gradually growing smaller as it gets closer to nozzle 415 . In preferred embodiments of the invention, vertical member 410 , like the segments of pipe 430 , the T-connectors 420 and 440 , and the flow reducers 460 , is comprised of polyvinyl chloride (PVC) plastic. Nozzle 415 can be manufactured by thermal die forming an end of vertical member 410 into nozzle 415 . The vertical members 410 can then be inserted and glued into the perpendicular inlets of T-connectors 440 to connect the vertical members 410 to the piping system 400 . In embodiments, in which vertical members 410 , segments of pipe 430 , the T-connectors 420 and 440 , and flow reducers 460 are comprised of PVC, the PVC piping can be covered or coated with a UV-resistant paint or other coating which helps those PVC pieces resist degradation from ultraviolet radiation, prolonging the life of piping system 400 . FIG. 5 is a cross-sectional view of exemplary piping system 500 , which illustrates the flow of seed (and/or fertilizer) through system 500 . As seed enters the system 500 at the perpendicular inlet of T-connector 520 , flow divider 510 acts to split the flow of seed in half, directing each half of the seed flow to each side of flow divider 510 and into interior segments of piping 505 . Each of the interior segments of piping 505 is connected to each other and to interior vertical members 530 a via T-connectors 508 , and the end segments of piping 515 are connected to end vertical members 530 b via elbow connectors 550 . In this exemplary embodiment 500 , the interior segments of piping 505 have a larger diameter than the end segments of piping 515 . Seed exits the vertical members 530 a and 530 b at relatively higher velocity from nozzle 535 , as depicted by flow arrows 538 . As seed is propelled horizontally away from T-connector 520 and flow divider 510 , it is caught by the cup-shaped baffles 545 that are connected to the top of the interior vertical tubes 530 a . Each baffle 545 has a closed top, and is shaped as a cup or closed half-pipe which “catches” and re-directs seed (and/or fertilizer) away from the horizontal flow into interior vertical tubes 530 a , as illustrated by flow arrows 533 a . In preferred embodiments, the baffles 545 are designed so that each interior vertical member 530 a catches and receives an approximately equivalent amount of seed. Each of the baffles 545 is connected to a respective interior vertical tube 530 a by connector 540 . As the flow of seed reaches the end piping segments 515 , all of the seed remaining in the flow is directed into end vertical members 530 b , as illustrated by flow arrows 533 b . Thus, there is no need for end vertical members 530 b to be connected to baffles that catch and redirect only a portion of the seed in the flow. By catching and redirecting approximately equal amounts of seed (and/or fertilizer), the baffles 545 ensure that approximately equal amounts of crops are planted in each row, and help prevent the device from jamming from one or more vertical tubes 530 a or 530 b having seed propelled into it at too great a rate. The baffles 545 may be manufactured from different materials, but in exemplary preferred embodiments, the baffles 545 are comprised of PVC plastic. In these embodiments, the baffles 545 are manufactured by thermal die forming, in which the PVC is heated and then formed/folded around a metal or wooden die having the desired cup-like, closed half-pipe shape for the baffle 545 . FIGS. 6A-E depict an exemplary interior vertical pipe 530 a having a nozzle 535 for propelling seed (and/or fertilizer) and attached to a baffle 545 via connector 520 . The bottom portion 540 of baffle 545 connects the baffle 545 to connector 520 , allowing the cup-shaped baffle 545 to catch and redirect seed into the vertical member 530 a . As depicted in FIGS. 6A-E , the baffle 545 may decrease in diameter further away from the bottom portion 540 of baffle 545 , and may comprise a notch that can attach to an edge of the horizontal piping. FIG. 7 depicts an exemplary embodiment of a vertical member 530 a in which a nozzle cover 710 has been attached to nozzle 535 . In this exemplary embodiment, the nozzle cover 710 comprises a plurality of flexible strands 710 a - c which aid in planting seeds on ground that is relatively dry and firm. When propelled from the nozzle 535 , the seeds may bounce off of the firm ground, away from nozzle 535 . Nozzle cover 710 helps catch and redirect seeds, helping the seeds to maintain their position in relatively orderly rows in the field. The exemplary embodiment 710 depicted in FIG. 7 is comprised of strands of flexible rubber hose 710 a - c . However, nozzle covers 710 may take varying forms and be composed of varying materials, including but not limited to a hose, skirt, curtain, or cone that helps direct seed from nozzle 535 . The following Examples are only illustrative. It will be readily seen by one of ordinary skill in the art that the present invention fulfills the objectives set forth above. After reading the foregoing specification, one of ordinary skill will be able to effect various changes, substitutions of equivalents, and various other embodiments of the invention as broadly disclosed therein. It is therefore intended that the protection granted herein be limited only by the definition contained in the appended claims and equivalents thereof. EXAMPLES FIG. 8 depicts an exemplary embodiment of a device 800 for planting seed. PVC T-connector 420 of device 800 can be attached, via a hose or other connector (not shown) to a broadcast planter or similar device for propelling seed and/or fertilizer. The T-connector 420 is attached to a set of horizontal PVC piping (not shown), which is enclosed by a piece of PVC pipe 810 . The PVC pipe 810 comprises a slit along its length, which allows the PVC pipe 810 to be stretched to enclose and fit snugly around the horizontal PVC piping of device 800 . The exemplary device 800 features 12 vertical members 410 , each comprised of PVC plastic and having a nozzle 415 , and which are spaced equidistantly from each other and connected to the horizontal PVC piping encased within PVC pipe 810 . The vertical members 410 are mounted onto metal frame 840 , to which PVC pipe 810 is also attached. The frame 810 comprises two metal handles 830 , which can be held by users and utilized to maneuver device 800 around a field for planting. Device 800 also features two skis 820 . The skis 820 are comprised of a metal, such as steel or aluminum, or a plastic, such as PVC. The device 800 slides on skis 820 as the users maneuver device 800 around a field, using handles 830 , to plant seeds in neat, equidistant rows from the nozzles 415 of the vertical tubes 410 of device 800 .

1a

TECHNICAL FIELD [0001] The present invention belongs to the field of food spreads, more specifically it relates to an emulsified spread based on olive oil that is not subjected to hydrogenation or hydroxylation, as well as to a method for preparing it. Optionally, the olive oil of the composition can be partially or totally substituted with any other vegetable oil. The spread of the present invention does not require cold storage. BACKGROUND [0002] The consumption of olive oil involves an important source of monounsaturated fats. As a result, it can contribute to the prevention and treatment of the predominant risk factor of atherosclerosis as well as to the prevention of coronary heart disease and cancer. [0003] Therefore olive oil is appreciated not only for its gastronomic value, but also for its curative and nutritional properties, identified since ancient times and scientifically proven after a number of epidemiological, clinical and experimental research works. [0004] The balanced composition of olive oil, formed mainly by monounsaturated oleic acid, but with a suitable amount of essential polyunsaturated linoleic and linolenic acids, and the presence of a large variety of antioxidants, justifies the preference of nutrition specialists for olive oil, also shared by gastronomists due to its peculiar organoleptic characteristics, which are pleasant to the taste. [0005] One of the main components that makes olive oil a product so beneficial for health is oleic acid, which is the main monounsaturated fatty acid of olive oil, as well as natural antioxidants. The substitution of saturated fatty acids, which increase bad cholesterol, with the monounsaturated fatty acids of olive oil allows reducing the total cholesterol and LDL (bad cholesterol) concentrations without reducing HDL (good cholesterol) levels. [0006] Therefore it is desirable to promote and favor the consumption of olive oil to the detriment of other animal fats. A possible strategy for favoring the consumption of olive oil is to present it in a different format, in the form of a spread. Olive oil can thus be presented as an alternative to other fats but without trying to change consumption habits, but rather adapting the presentation form so that it can be consumed as a real alternative to other less healthy fats. [0007] Manufacturing a spread with vegetable oils has, however, an important drawback, and it is that all vegetable oils are liquid at room temperature, including olive oil, and as of today there is not a natural source which offers vegetable fat with the consistency and plasticity suitable for being converted into a margarine spread. [0008] Different alternatives for producing spreads from vegetable oils have been described up until now. [0009] Patent ES 2087074 describes a spread based on soybean oil subjected to refining to obtain a very specific fatty acid composition. For the thickness of the composition, a cooling which causes phase inversion is carried out. [0010] Patent ES 21128057 describes a spread based on vegetable oils subjected to hydrogenation and it presents a very specific fatty acid composition. [0011] U.S. Pat. No. 6,113,971 describes a method for preparing a butter based on olive oil comprising chemically transforming the olive oil by means of hydrogenation, a process by means of which part of the unsaturated fatty acids are converted in saturated fatty acids, thus achieving the plasticity sought. The product obtained by means of this method has the drawback that it does not preserve the same amount of monounsaturated fatty acids as natural olive oil does, therefore losing part of its healthy properties. [0012] Application ES 2168997 describes a method for obtaining an olive oil paste from stearin which is the solid fraction of olive oil. It is mixed with emulsifying agents and after a heat treatment and stirring it is left to cool to obtain a solid homogeneous paste. [0013] Application ES 2162601 relates to the use of olive oil for the elaboration of margarines, butters, wheys, emulsions, creams, chocolates and the like. It specifically proposes substituting part of the vegetable oils typical of these products with olive oil. DESCRIPTION OF THE INVENTION [0014] The authors of the present invention have developed an alternative spread with a high proportion of olive oil preserving all the beneficial characteristics thereof. The product of the present invention has consistency and plasticity characteristics at room temperature that make it suitable as a spread for food use as a substitute for butters or margarines. [0015] The versatility of the elaboration process allows partially or totally substituting the olive oil used in the elaboration of the spread with other vegetable oils. As is known, edible vegetable oils have a vital function in our organism and form one of the most important energy sources, which is essential for maintaining the balance of lipids, cholesterol and lipoproteins circulating in the blood; they provide vitamins A, D, E and K and essential oils that our organism is not capable of producing; and furthermore, they have the capacity of enhancing many of the sensory characteristics of foods, such as the taste, aroma and texture. Therefore it can also be of interest for the consumer to find spreads containing other vegetable fats such as sunflower, soybean, corn, rapeseed or canola, safflower, peanut, avocado or cottonseed fats. All these oils also have a lipid profile with a high content of polyunsaturated fatty acids (omega 6 series) and antioxidant substances such as tocopherols. The use of these oils in the elaboration of spreads broadens the color and taste range for this type of product. [0016] The invention provides an olive oil spread characterized in that it comprises between 70-85% olive oil, between 1-6% emulsifiers, between 0-2% thickeners and between 12.5-29% water, and wherein the oil has not been subjected to any hydrogenation or hydroxylation treatment. [0017] In a preferred embodiment of the invention the spread comprises between 75-80% olive oil, 2-5% emulsifiers, 0.2-1% thickeners and between 15-20% water. [0018] The main element of the emulsion is the olive oil, which furthermore acts as the dispersed phase of the emulsion. The olive oil used can be selected from virgin olive oil, extra virgin olive oil, refined olive oil, olive oil, olive-pomace oil or mixtures thereof. [0019] In a particular embodiment of the invention, the spread is elaborated by substituting part of the olive oil with a vegetable oil. The substitution can be partial or total. This means that from the total oil content of the spread of the invention, the percentage of vegetable oils can vary between 0-100% with respect to the percentage of olive oil. In the context of the present invention, the vegetable oils that can be included in the elaboration of the olive oil spread are selected from sunflower, soybean, corn, rapeseed or canola, safflower, peanut, avocado or cottonseed oils. [0020] The emulsifiers or emulsifying agents have the function of favoring and facilitating the emulsion between the water (continuous phase) and the oil (dispersed phase) due to the fact that they have a hydrophilic end and another hydrophobic end. In the present invention, the emulsifiers are selected from mono and diglycerides of fatty acids, esters of the mono and diglycerides of fatty acids, sucrose esters, sucroglycerides, polyglyceride esters of fatty acids or mixtures thereof. The preferred embodiment of the invention contemplates the use of sucrose esters. [0021] The thickeners present in the product of the invention have the purpose of providing the desired texture and consistency. The percentage of thickeners according to the invention provides rheological characteristics to the product that make it suitable for its use as a margarine spread. The thickeners suitable for preparing the spread of the present invention are selected from locust bean gum, guar gum, tara gum, agar-agar, carrageenans, alginates, xanthan, gellan, high methoxyl (HM) pectins, low methoxyl (LM) pectins, microcrystalline cellulose (MCC), MCC-Na, methylcellulose, modified starches or mixtures thereof. [0022] As an optional element, the spread of the invention can contain a preservative or antioxidant to prevent the oxidation and rancidity thereof. Both hydrophilic antioxidants, such as citric acid, potassium sorbate or ascorbic acid, and hydrophobic antioxidants, such as tocopherols, are contemplated among the preferred preservative and antioxidant components. When seed oils are used, the tocopherols contained therein will act as antioxidants in the product. [0023] The present invention also contemplates the option of adding spices or other food ingredients, such as for example, garlic, onion, rosemary, etc. [0024] The invention relates to the method for preparing the emulsified spread comprising: a. Dissolving the emulsifiers and thickeners in water by means of stirring to form the continuous phase of the emulsion b. Incorporating the olive oil (dispersed phase) on the continuous phase at a speed between 1500 to 6000 rpm in an emulsifier apparatus. [0027] In a preferred embodiment of the invention, the emulsifiers and thickeners are dissolved in water at a temperature between 30 and 60° C. [0028] The speed of the emulsifier apparatus is an important factor in obtaining a correct emulsion. Obtaining an emulsified product with the characteristics suitable for its use as a spread according to the present invention can be done within a range of 1500 to 6000 rpm, although it is preferred to use a rate of 5000 to 5700 rpm and more preferably a rate around 5400 rpm. [0029] In those embodiments in which a vegetable oil other than olive oil is included, the oil can be incorporated in the emulsifier apparatus at the same time or can be previously premixed such that the mixture of the oils is incorporated on the continuous phase. [0030] Another aspect of the invention relates to the application of the spread. A preferred use of the spread of the invention is in food as a substituent of butters and margarines. These are less healthy fat sources, therefore the main use of the product of the invention is for spreading on pan, cookies, cakes and any type of food commonly used for spreading butters and margarines. In addition to this application as a spread, the spread of the invention can be used to cook and generally as a gastronomic element. When subjected to a heat source, the spread of the invention melts and acquires a liquid texture which makes it suitable for several culinary applications. [0031] Another remarkable application of the product of the invention is the cosmetic use thereof. The spread of the invention can be used as an ingredient in the elaboration of creams, unguents, lotions, gels, shampoos and other products of the cosmetic industry. EXAMPLES [0032] The following examples serve to illustrate the invention. Example 1 Preparation of the Formulation F1, F2 and F3 [0033] Two formulations were prepared according to the invention with the following percentages of each element: F1 80% extra virgin olive oil 16.4% water 3% sucrose ester 0.4% xanthan gum 0.2% guar gum F2: 75% extra virgin olive oil 22.3% water 2.5% sucrose ester 0.2% xanthan gum F3: 85 % extra virgin olive oil 12.5% water 2.5% sucrose ester [0049] In the elaboration of spreads F1, F2 and F3 first a mix was made with all the powder components. [0050] In the case of F1, sucrose ester, xanthan gum and guar gum were mixed; for F2, sucrose ester and xanthan gum were mixed; and for F3, only sucrose ester was used. [0051] Then each of the “mixes” was dissolved in distilled water at 50° C. with stirring. A paste making up the continuous phase of the future emulsion was thus formed. [0052] Finally, Blanqueta extra virgin olive oil (dispersed phase) was incorporated in the emulsifier apparatus at a controlled rate and at a stirring rate of 5400 rpm. In any of these formulations the olive oil can be partially or totally substituted with other vegetable oils such as the aforementioned ones. [0053] In formulations F1, F2 and F3 the olive oil can be substituted with sunflower oil, the product obtained has a whiter color than when using olive oil. [0054] The obtained emulsions F1, F2 and F3 were subjected to a series of tests to determine their rheological characteristics. Example 2 Rheological Characterization [0055] The flow curves at 30° C. were obtained for the rheological characterization. The developed formulations had a pseudoplastic behavior. The curves were adjusted to the Ostwald-de Waele model, the following values of n (flow index) and K (consistency index) being obtained: [0000] Flow curves (0-100 s −1 in 300 s) Sample n K (Pa · s n ) F1 Formulation Minimum 0.16 62.9 Guar 30° C. Maximum 0.21 76.8 F2 Formulat. Minimum 0.2748 22.014 75% oil Maximum 0.2221 27.782 30° C. F3 Formulat. Minimum 0.3189 20.128 85% oil Maximum 0.3191 22.112 30° C. [0056] The obtained values correspond to a product of consistency and plasticity suitable for its use as food spread. Furthermore, the product remains stable at room temperature, i.e., it does not need refrigeration.

1a

RELATED APPLICATION This application claims priority of U.S. Provisional Patent Application Ser. No. 60/547,590 filed Feb. 25, 2004, and U.S. Provisional Patent Application Ser. No. 60/564,671, filed Apr. 21, 2004 which are incorporated herein by reference. FIELD OF THE INVENTION This invention relates to a barbell for exercise purposes such as weightlifting and more particularly to such exercise apparatus which includes means for supporting a number of weights on both ends of the apparatus and includes rotatable handgrips, a sliding counterweight supported on a central bar, and rectangular curved weights which may be supported on the ends of the apparatus. BACKGROUND OF THE INVENTION Barbells are commonly used to perform a variety of exercises including curling and weightlifting, and it has been proposed to provide rotating handgrips for use in such apparatus so that the user's grip may be accommodated in any position and is not restricted to an angle parallel to the axis of the device. In particular, U.S. Pat. Nos. 3,384,370; 4,618,183; 4,629,184; 5,334,113; 6,022,300 and Re. 33,218 all disclose barbell arrangements having handgrips which are rotatably supported so that their angle relative to the bar may be adjusted. One problem associated with prior art barbells resides in the fact that if the bar is to resist the bending forces imposed when the bar is lifted with weights on the end, it must be formed of a strong and relatively heavy material. The weight of this bar imposes a minimum weight on the exercise apparatus even without any end weights. Another problem is that the use of disk-like end weights creates problems in storage and transportation of a barbell with the associated weights. Another problem associated with conventional barbells, with or without rotatable handgrips, is that it is inconvenient and awkward to provide a greater weight on one end than the other in order to impose asymmetrical stresses on the user's muscles during exercise. SUMMARY OF THE INVENTION These problems are addressed by our invention, which is disclosed in detail subsequently, and which provides a weightlifting apparatus including a pair of spaced outer rings which support rotatable handgrips and, in a preferred embodiment of the invention, are connected to one another by a supporting structure constituting a pair of intermediate bars each connected at its opposite ends to the opposed edges of the two rings which support the rotatable handles. The connecting bars are preferably curved and joined to the rings so as to present their curved surfaces externally of the barbell and their opposed concave surfaces facing one another. These connecting bars do not extend beyond lines tangent to the two handle supporting rings so that the bars will not hit the user's body during exercise. The connecting bars are preferably formed of tubular steel so that they may have a lower weight collectively than the single conventional longitudinal bar of a barbell. While the connecting bars of the present invention are preferably curved, in other embodiments of the invention they could be formed of straight sections, sections with an intermediate bend projecting outwardly or elliptical sections. Each of the outer rings rotatably supports an inner ring having an outer diameter complementary to the inner diameter of the outer ring. The bearing surface between the inner diameter of the outer ring and the outer diameter of the inner ring may either be frictional or may be equipped with anti-friction bearings such as ball bearings, roller bearings, or the like. Alternatively, low friction materials such as nylon may be coated on the contacting surfaces. Each inner ring is bisected with a grip handle so that the inner ring may be rotated to any convenient position within the outer ring by forces exerted on the handles. This construction provides a very strong, lightweight, rigid exercise apparatus. In embodiments of the invention which will be subsequently disclosed in detail, the supporting structure for the rings includes a central straight bar, preferably formed of tubing, connecting the two rings at their points of closest separation, midway between the two outer connecting bars. A relatively small weight is slidingly supported on this central bar so that when the bar is tipped in one vertical direction or the other, the weight will slide toward the downward end. Thus the bar may be weighted in an asymmetrical manner so that the work exerted by the exerciser is greater on the side with the weight than the opposite side. This allows the exerciser to provide higher forces to one muscle group than another and allows shifting of the weights between exercises. Thus, asymmetrical stresses may be imposed to exercise the oblique muscles and related groups. Prior art barbells typically employ disk-shaped weights. In one embodiment of the present invention the weights to be secured on supporting extensions on the outer sides of the two outer rings are elongated rectangles, preferably crescent-shaped and curved to a radius similar to the rings so that the innermost weight can rest against the ring and the outermost weights curve around the inner weights. The rectangles extend parallel to the rings to give the entire bar, with the associated weights, a narrow profile for storage or transportation. The exercise device of the present invention is useful for a wide variety of exercises. In particular: 1. The biceps may be exercised by lifting and rotating with the handle parallel to the central axis; 2. The triceps may be exercised by lifting and rotating with the handles perpendicular to the central axis; 3. The trapezius muscles may be exercised with grips on the end of either curved connecting bar; 4. Pushups may be performed with hands on the handle perpendicular to the central axis; and 5. A normal bench press may be performed with the correct support angles safely because the double connecting bar lies on the chest rather than creating the danger of a single conventional bar hitting the thorax. It is contemplated that a version of the present invention may be produced without extending weight supporting sections on the outer sides of the two rings. This version would provide a single weight for exercise and would be useful for lower strength individuals, and some females, as well as being more compact for storage and transportation than the version with the extending weight supporting sections. BRIEF DESCRIPTION OF THE DRAWINGS Other objects, advantages and applications of the present invention will be made apparent by the following detailed description of preferred embodiments of the invention. The description makes reference to the accompany drawings in which: FIG. 1 is a perspective view of a person using a first embodiment of the barbell for exercising, illustrating, in phantom lines, the alternative positions for imposing asymmetrical forces on the muscles; FIG. 2 is a top perspective view of the preferred embodiment of our invention carrying several crescent-shaped weights; FIG. 3 is a fragmentary perspective view of the embodiment of FIG. 2 supporting conventional disc-shaped weights; FIG. 4 is an exploded view of a preferred embodiment of our invention; and FIG. 5 is a perspective view of an alternative embodiment of the invention without end bars for supporting additional weights. FIG. 6 is a perspective view of an alternative embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION Referring to FIGS. 1–4 , a preferred embodiment of our exercise apparatus comprises a pair of outer rings 10 and 12 , preferably formed of tubular steel, aluminum or another rigid material. The rings 10 each have a number of tapped holes 14 , formed in regular intervals about their perimeter for securing inner rotatable rings in a manner which will be subsequently described. The two outer rings 10 and 12 are joined to one another by a pair of curved, tubular, connecting bars 16 and 18 . The ends of the bars are welded, or otherwise secured to spaced points on the perimeter of the outer rings 10 and 12 . A straight center bar 20 , which is preferably rectangular in cross-section, extends intermediate the two curved connecting bars 16 and 18 and also has its ends secured to the outer perimeter of the two rings 10 and 12 midway between the points of connection of the bars 16 and 18 . The connecting bar 20 may be solid or tubular. The bars 16 , 18 and 20 are connected to the rings 10 and 12 so that the rings, as well as their connecting bars, all lie in a common plane. The lengths of the bars 16 , 18 and 20 are preferably such that the centers of the two rings 10 and 12 are separated by approximately 10–15 inches, which represents a comfortable distance for gripping the exercise apparatus. A pair of inner rings 22 and 24 which have outer diameters slightly smaller than the inner diameters of the rings 10 and 12 , are secured within the outer rings by opposed pairs of retaining plates 28 , 30 , 32 and 34 . The retaining plates 28 , 30 , 32 and 34 have a number of screw holes 36 formed through their thickness. The retaining rings may be secured to the opposed faces of the outer rings 10 and 12 with screws 31 , to capture the inner rings 22 and 24 between them. Inner rings 22 and 24 make a loose fit within the inner diameters of the outer rings 10 and 12 . Each of the inner rings 22 and 24 has a cylindrical grip member 38 and 40 , preferably with a serrated surface, extending diametrically across the respective ring. A metal weight 42 is slidably supported on the straight connecting bar 20 . The fit is such that it may easily slide from one side to the other, as the bar is appropriately inclined. In FIG. 1 , the weight 42 is shown at the end toward the right arm of the exerciser 50 and shown in phantom at a position adjacent to his left arm. In the embodiment of FIGS. 1 through 4 , weight supporting, rectangular cross-section extensions 52 and 54 , are fixed to the outer rings 10 and 12 respectively, at points diametrically opposed to the points where the center connecting bar 20 joins those rings. A plurality of weights may be supported on each extension 52 and 54 in the manner of a conventional barbell. FIGS. 1 and 3 illustrate crescent-shaped weights formed in accordance with the present invention. FIG. 3 illustrates several conventional disc-shaped weights 60 secured on a bar end 52 and retained by a conventional spring clip 62 . Another novel aspect of the present invention resides in the use of crescent-shaped weights 64 A, 64 B, and 64 C, rather than the conventional disc-shaped weights 60 . These crescent-shaped weights preferably have a thickness similar to the thickness of outer rings 10 and 12 and have central holes which allow them to be supported on the extensions 52 and 54 . They may be retained with conventional spring slips 62 . When equipped with the crescent-shaped weights, the exercise apparatus has a relatively flat profile and my be conveniently stored or packaged. The crescent-shaped weight 64 A has a concave surface with a diameter that approximates that of the outer ring so it slightly extends around the outer ring. The weights 64 B and 64 C have concave surfaces which allow them to closely nestle the convex surfaces of the larger weights. The crescent-shaped weights provide a number of advantages over conventional weightlifting bars which may be equipped with disc-shaped weights with central holes that fit over an extending bar such as the bar 52 in addition to the resulting compact configuration and ease of storage. Disc-shaped weights tend to rotate during exercise resulting in forces that destabilize the conventional exercises that may be performed by the bar. The crescent-shaped weights lock into one another to prevent rotation. Additionally, the crescent-shaped weights minimize the length of the exercise bar and thus lower force moments which tend to cause the bar to twist during use. Finally, disc-shaped weights tend to make contact with the user's elbows during many exercises, particularly trapezius pulls involving grabbing the center of the bar with both hands and lifting towards the chin. Since the crescent-shaped bars do not extend out of the plane of the weightlifting apparatus, they do not create such interference. The embodiment of the invention illustrated in FIG. 5 does not have the weight supporting extensions 52 and 54 which form part of the first embodiment of the invention. Rather, the exercise apparatus simply consists of the rings and their rotatable handles and the associated connecting bars and the sliding weight. In alternative embodiments of the invention, an anti-friction bearing could be used to support the inner rings 22 and 24 within the outer rings 10 and 12 . This might be a ball bearing or a roller bearing. Alternatively, the engaging surfaces of one of the elements could be coated with an anti-friction material. Alternate physical arrangements also might be employed for securing the inner rings 22 and 24 within the outer rings 10 and 12 , as opposed to the retaining plates illustrated in the drawings. The use of connecting bars 16 , 18 and 20 which are preferably tubular, gives the weightlifting apparatus a rigidity without the weight of conventional barbells. In an alternative embodiment to the invention, the center bar 20 and its supporting sliding weight 42 could be omitted so as to only allow for symmetrical exercises. As illustrated in FIG. 1 , by inclining the bar in one direction or another, asymmetrical forces would be imposed on the exerciser's muscles while using the bar for otherwise conventional exercises.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 10/025,059, filed Dec. 19, 2001, pending. FIELD OF THE INVENTION [0002] The invention provides an absorbent article having a multi-tone signal of at least one color. The effect of the multi-tone signal creates a perception of depth by a user viewing the topsheet surface of the absorbent article. BACKGROUND OF THE INVENTION [0003] Printing on or below the top surface of an absorbent article is known in the art. Printing to create a signal that masks stains is also known. Overcoming the problem of unsightly stain during, for example, a woman's menstrual period has been disclosed. What has not been disclosed or taught is the use of multi-toned printing to create a signal that provides a perception of depth to an absorbent article when the article is viewed from its top or viewing surface. By creating a perception of depth within the absorbent article a user is reassured prior to use and during use that fluid will be drawn deep inside the product and away from a user's body. [0004] Through the use of innovative topsheet materials, secondary topsheet materials, absorbent gelling materials and breathable backsheets, the technology in absorbent articles, and particularly sanitary napkins, has drastically advanced to provide women with more than adequate, if not excellent, products that absorb menses and other fluids away from a woman's body. However, much of this technology is often hidden and therefore not viewable. When seen, absorbent components often do not readily or visually communicate to a user the existence of this enhanced technology. [0005] The ability to communicate to a consumer the existence of enhanced functioning of an absorbent article is a premium asset to any absorbent article. Hence, the use of the multi-toned signals has been created to begin to address the problem of such communication. This is especially so since mostly all of the products on the market today have as their main function the objective to mask menses rather than conveying the product's enhanced functioning power. The art is replete with examples of the use of a one-tone signal for such masking. [0006] Communicating enhanced functioning characteristics by creating the perception of depth within an absorbent article is one unique and novel way to solve this problem, that prior to this reduction to practice has not been taught, suggested or disclosed by the prior art. Using multiple tones (i.e., at least two) of a color and/or multiple tones and multiple colors together to create a perception of depth can engender in a user the perceived belief of better protection and enhanced functioning by creating the perception of depth once a user has viewed the multi-tone configuration from the viewing surface of the absorbent article, such perception continuing through and after wear of the absorbent article. SUMMARY OF THE INVENTION [0007] Accordingly, the invention provides an absorbent article having an upper surface, a lower surface and a periphery comprising a topsheet having a bottom surface and a viewing surface positioned opposite to the bottom surface. The viewing surface faces upwardly towards the upper surface of the absorbent article. The absorbent article further comprises a backsheet having a garment facing surface and a user facing surface positioned oppositely to the garment facing surface, the backsheet being joined to the topsheet. [0008] An absorbent core having a top surface and a bottom surface that is positioned opposite to the top surface. The absorbent core is positioned between the topsheet and the backsheet. The viewing surface of the absorbent article preferably, but not necessarily, has at least two portions, i.e., a colored portion and a non-colored portion. The colored portion and the non-colored portion are viewable from the viewing surface of the topsheet. The colored portion has at least two shades, a first shade and a second shade. The first shade is positioned substantially within the second shade. The second shade is different, either in lightness, darkness, and/or color, from the first shade. The multi-shades operate to create a perception of depth within the absorbent article by a user looking upon the viewing surface of the topsheet. In one embodiment herein, the first shade of the color is darker than the second shade of the color. Alternatively, the first shade is lighter than the second shade. [0009] The color of the first shade and the second shade of the colored portion and the non-colored portion are measured by reflectance spectrophotometer ASTM standard test methodology. Tristimulus L*, a*, b* values are measured from the viewing surface of the topsheet inboard of the absorbent article's periphery. These L*, a*, b* values are reported in terms of the CIE 1976 color coordinate standard The color differences between the colored portion and the non-colored portion are measured at a first point, a second point, and a third point on the viewing surface of the topsheet inboard of the periphery of the absorbent article. Preferably, each one of the points noted (i.e., 1, 2 and 3) resides fully within the periphery of the absorbent core. For example, the first point is measured within the first shade, the second point is measured within the second shade, and the third point is measured within the non-colored portion of the absorbent article. The color differences are calculated according to method ASTM D2244-99 “Standard Test Method for Calculation of Color Differences from Instrumentally Measured Color Coordinates.” [0010] The difference in color (i.e., ΔE*) between the first shade and the second shade should be at least 3.5. The ΔE* is calculated by the formula ΔE*=[(L* X· −L* Y ) 2 +(a* X· −a* Y ) 2 +(b* X −b* Y ) 2 ] 1/2 . X may represent points 1, 2 or 3. Y may represent points 1, 2 or 3. X and Y should never be the same two points of measurement at the same time. In other words, X≠Y. The difference in color between the first shade and the non-colored portion is at least 6. The difference in color between the second shade and the non-colored portion is at least 3.5. Preferably, the size of the colored portion ranges from about 5% to about 100% of the viewing surface of the topsheet. Also preferably, the first shade of the colored portion is positioned substantially centrally in relation to the second shade of the colored portion. However, so long as the shades are in proper spatial relationship to one-another such that the depth perception phenomena is created, any suitable positioning of the shades is suitable and foreseeable by one of skill in the art and are therefore acknowledged as suitable alternative embodiments of the invention. [0011] In one embodiment herein, the colored portion may be an insert positioned between the topsheet and the absorbent core. In another embodiment, the colored portion forms a part of the topsheet. In yet another embodiment herein, the colored portion forms a part of the absorbent core whereby the colored portion is viewable from the viewing surface of the topsheet. Alternatively, the colored portion may be a multi-layered insert positioned beneath the topsheet. [0012] Any topsheet material that allows the colored portion to be readily seen from the viewing surface of the topsheet is suitable. For example, formed film material, nonwovens, other topsheet materials known in the art or combinations thereof are suitable. [0013] In an alternative embodiment herein, the absorbent article provides a colored portion and is substantially without a non-colored portion. The colored portion is viewable from the viewing surface of the topsheet and has at least two shades, a first shade and a second shade. The first shade is positioned substantially within the second shade, the second shade being different from the first shade. The at least two shades operate to create a perception of depth within the absorbent article by a user looking upon the viewing surface of the topsheet. BRIEF DESCRIPTION OF THE DRAWINGS [0014] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming the present invention, it is believed that the invention will be better understood from the following descriptions which are taken in conjunction with the accompanying drawings in which like designations are used to designate substantially identical elements, and in which: [0015] [0015]FIG. 1 is a perspective drawing of the absorbent article; [0016] [0016]FIG. 2 is a planar view of the absorbent article of FIG. 1; [0017] [0017]FIG. 3 is a planar view of an alternative embodiment of FIG. 1; and [0018] [0018]FIG. 4 is a planar view of the proper testing form of the absorbent article of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION [0019] “Absorbent articles” as referred to herein are primarily sanitary napkins, pantiliners, or incontinence pads that are worn in the crotch region of an undergarment. It is even conceivable that baby diapers, adult incontinence diapers, and human waste management devices benefit from the present invention even though they are conventionally not worn in conjunction with an undergarment. [0020] The term ‘color’ as referred to herein include any primary color, i.e., white, black, red, blue, violet, orange, yellow, green, and indigo as well as any declination thereof or mixture thereof. The term ‘non-color’ or ‘non-colored’ refers to the color white which is further defined as those colors having an L* value of at least 90, an a* value equal to 0≠2, and a b* value equal to 0≠2. [0021] The term ‘disposable’ is used herein to describe absorbent articles that are not intended to be launched or otherwise restored or reused as absorbent articles (i.e., they are intended to be discarded after a single use and, preferably to be recycled, composted or otherwise disposed of in an environmentally compatible manner). [0022] Non-limiting examples of panty liners and sanitary napkins which may be provided with a multi-tone signal that operates to create depth perception include those manufactured by The Procter & Gamble Company of Cincinnati, Ohio as: ALWAYS® Pantiliners with DriWeave® manufactured according to U.S. Pat. Nos. 4,324,246; 4,463,045; and 6,004,893; ALWAYS® Ultrathin Slender Maxi with Wings manufactured according to U.S. Pat. Nos. 4,342,314, 4,463,045, 4,556,146, B1 4,589,876, 4,687,478, 4,950,264, 5,009,653, 5,267,992, and Re. 32,649; ALWAYS® Regular Maxi; ALWAYS® Ultra Maxi with Wings; ALWAYS® Maxi with Wings; ALWAYS® Ultra Long Maxi with Wings; ALWAYS® Long Super Maxi with Wings; and ALWAYS® Overnight Maxi with Wings, each aforesaid publication being incorporated by reference herein. [0023] [0023]FIG. 1 provides a perspective view of the absorbent article 10 . FIG. 2 provides a planar view of the absorbent article of FIG. 1. The absorbent article 10 herein has an upper surface 13 , a lower surface 14 (not seen) and a periphery 12 comprising a topsheet 25 having a bottom surface 27 (not shown) and a viewing surface 28 positioned opposite to the bottom surface 27 . The viewing surface 28 faces upwardly towards the upper surface 13 of the absorbent article 10 . The absorbent article 10 further comprises a backsheet 15 (not shown) having a garment facing surface 16 (not shown) and a user facing surface 17 (not shown) positioned oppositely to the garment facing surface 16 , the backsheet 15 being joined to the topsheet 25 . [0024] The absorbent article 10 also comprises an absorbent core 20 having a top surface 21 and a bottom surface 22 (not shown) that is positioned opposite to the top surface 21 . The absorbent core 20 is positioned between the topsheet 25 and the backsheet 15 . In the embodiment shown in FIG. 1 the absorbent article 10 has at least two portions, i.e., a colored portion 40 and a non-colored portion 50 . The colored portion 40 and the non-colored portion 50 are viewable from the viewing surface 28 of the topsheet 25 . The colored portion 40 has at least two shades, a first shade 42 and a second shade 44 . Preferably, but not necessarily, and as is shown in FIG. 1, the first shade 42 is positioned substantially within the second shade 44 . The second shade 44 is different, either in lightness, darkness, and/or color, from the first shade 42 . The multi-shades operate to create a perception of depth within the absorbent article by a user looking upon the viewing surface 28 of the topsheet 25 . In one embodiment herein, the first shade 42 of the color is darker than the second shade 44 of the color. Alternatively, the first shade 42 is lighter than the second shade 44 . The lightness and darkness of the shades, whether two or greater than two shades, are configured to create a perception of depth by a user looking upon the viewing surface 28 of the absorbent article 10 . [0025] The color of the first shade 42 and the second shade 44 of the colored portion 40 and the non-colored portion 50 are measured by the reflectance spectrophotometer according to the colors' L*, a*, and b* values. The L*, a*, and b* values are measured from the viewing surface 28 of the topsheet 25 inboard of the absorbent article's periphery 12 . The color differences between the colored portion 40 and the non-colored portion 50 are measured at a first point 100 , a second point 110 , and a third point 120 on the viewing surface 28 of the topsheet 25 inboard of the periphery 12 of the absorbent article 10 . Preferably, each one of the points 100 , 110 , and 120 resides fully within the periphery 12 of the absorbent core 20 . For example, the first point 100 is measured within the first shade 42 , the second point 110 is measured within the second shade 44 , and the third point 120 is measured within the non-colored portion 50 of the absorbent article 10 . [0026] The color differences are calculated using the L*, a*, and b* values by the formula ΔE=[(L* X· −L* Y ) 2 +(a* X· −a* Y ) 2 +(b* X −b* Y ) 2 ] 1/2 . Herein, the ‘X’ in the equation may represent points 1, 2 or 3. Y may represent points 1, 2 or 3. X and Y should never be the same two points of measurement at the same time. In other words, X≠Y. Where greater than two shades of a color(s) are used, the ‘X’ and ‘Y’ values alternately include points of measurement in them also. The key to the ΔE calculation herein is that the ‘X’ and ‘Y’ values should not stem from the same measured point on the viewing surface. In those instances where there is effectively no non-colored portion 50 within the confines of the measurement area, the ‘X’ values should flow from a point different in spatial relationship to the ‘Y’ values, but within the confines of the absorbent core periphery (see FIG. 4). [0027] The difference in color (ΔE*) between the first shade 42 and the second shade 44 should be at least 3.5. The difference in color between the first shade 42 and the non-colored portion 50 is at least 6. The difference in color between the second shade 44 and the non-colored portion 50 is at least 3.5. [0028] Preferably, the size of the colored portion 50 ranges from about 5% to about 100% of the viewing surface 28 of the topsheet 25 . Also preferably, the first shade 42 of the colored portion 50 is positioned substantially centrally in relation to the second shade 44 of the colored portion 50 . However, so long as the shades are in proper spatial relationship to one-another such that the depth perception phenomena is created, any suitable positioning of the shades is foreseeable by one of skill in the art and are therefore acknowledged as suitable alternative embodiments of the invention. [0029] In one embodiment herein, the colored portion 40 may be an insert positioned between the topsheet 25 and the absorbent core 20 . In another embodiment, the colored portion 40 forms a part of the topsheet 25 . In yet another embodiment herein, the colored portion 40 forms a part of the absorbent core 20 whereby the colored portion 40 is viewable from the viewing surface 28 of the topsheet 25 . Alternatively, the colored portion 40 may be a multi-layered insert positioned beneath the topsheet 28 . [0030] Any topsheet material that allows the colored portion to be readily seen from the viewing surface 28 of the topsheet 25 is suitable. For example, formed film material, nonwovens, or combinations thereof are suitable. [0031] In an alternative embodiment herein, the absorbent article 10 provides a colored portion 40 wherein the viewing surface 28 of the topsheet 25 is substantially without a non-colored portion. By the term ‘substantially without a non-colored portion’ it is meant herein that color white is less than or equal to 5% of the total surface area of the viewing surface 28 . FIG. 3 provides an absorbent article wherein the first shade 42 is lighter and the second shade 44 is darker. [0032] Also alternatively is an embodiment in which a color different from the color of the first shade 42 and the second shade 44 operates as a boundary between the two shades. In other words, this boundary 48 (not shown) rings the outer perimeter of the second shade 44 and separates the second shade 44 from the first shade 42 . [0033] Analytical Methodology—Hunter Color [0034] The color scale values, utilized herein to define the darkness/lightness of the materials of the absorbent articles according to the present invention, is the widely accepted CIE LAB scale. Measurements are made with a Hunter Color reflectance meter. A complete technical description of the system can be found in an article by R. S. Hunter, ‘photoelectric color difference Meter’, Journal of the Optical Society of America, Vol. 48, pp.985-95, 1958. Devices specially designed for the measurement of color on the Hunter scales are described in U.S. Pat. No. 3,003,388 to Hunter et al., issued Oct. 10, 1961. In general, Hunter Color “L” scale values are units of light reflectance measurement, and the higher the value is, the lighter the color is since a lighter colored material reflects more light. In particular, in the Hunter Color system the “L” scale contains 100 equal units of division. Absolute black is at the bottom of the scale (L=0) and absolute white is at the top of the scale (L=100). Thus in measuring Hunter Color values of the materials used in the absorbent articles according to the present invention, the lower the “L” scale value, the darker the material. The absorbent articles herein, and hence the materials of which the absorbent articles are made of, might be of any color provided that the L Hunter value defined herein is met. [0035] Colors can be measured according to an internationally recognized 3D solid diagram of colors where all colors that are perceived by the human eye are converted into a numerical code. The CIE LAB system is similar to Hunter L, a, b an is based on three dimensions, specifically L*, a*, and b*. [0036] When a color is defined according to this system L* represents lightness (0=black, 100=white), a* and b* independently each represent a two color axis, a* representing the axis red/green (+a=red, −a=green), while b* represents the axis yellow/blue (+b=yellow, −b=blue). FIG. 4 shows the proper representation of the L, a, and b axes. [0037] A color may be identified by a unique ΔE value (i.e., different in color from some standard or reference), which is mathematically expressed by the equation: Δ E *=[( L* X· −L* Y ) 2 +( a* X· −a* Y ) 2 +( b* X −b* Y ) 2 ] 1/2 [0038] ‘X’ represents the standard or reference sample which may either be a ‘white’ sample or a ‘colored’ sample, e.g., one colored shade may be compared to another colored shade. [0039] It is to be understood that the tristimulus color values and ΔE* considered herein are those measured on the materials of interest (e.g., the colored and non-colored portions on the viewing surface of the topsheet disclosed herein). [0040] The Hunter color meter quantitatively determines the amount (percent) of incident light reflected from a sample onto a detector. The instrument is also capable of analyzing the spectral content of the reflected light (e.g., how much green is in the samples). The Hunter color meter is configured to yield 3 values (L*, a*, b* and ΔE* which is total color). The L* value is simple the percent of the incident (source) light that is reflected off a target sample and onto the detector. A shiny white sample will yield an L* value near 100 while a dull black sample will yield an L* value of about 0. The a* and b* value contains spectral information for the sample. Positive a* value indicates the amount of green in the sample. [0041] Testing is conducted using a Lab Scan XE 45/0 geometry instrument to measure the different shaded options for the visual signal zone. The Hunter Color in CIE lab scale 2° C. was measured on each pad in 3 portions. A 0.7 inch diameter port was used having a 0.50 inch area view, which was the largest size able to measure each zone discretely; i.e., this 0.5 inch area view is important for the purposes these measurements and should not be made smaller than the 0.5 inch area view prescribed. The instrument was calibrated using standard white and black tiles supplied by the instrument manufacturer. [0042] Color Zone Measurement for Pad Topsheet Appearance [0043] For measuring the L*, a*, and b* values for the invention herein, a standard, industry-recognized procedure is used. The topsheet color is measured using a reflectance spectrophotometer in accordance with method ASTM E 1164-94, “Standard Practice for Obtaining Spectrophotometric Data for Object-Color Evaluation”. This standard method is followed but specific instrument settings and sampling procedure are given here for clarity. Sample color is reported in terms of the CIE 1976 color coordinate standard as specified in ASTM E 1164-94 and ASTM D2264-93, section 6.2. This consists of three values; L* which measures sample “lightness”, a* which measures redness or greenness, and b* which measures yellowness or blueness. Apparatus Reflectance 45°/0° Hunter Labscan XE, or equivalent Spectrophotometer HunterLab Headquarters, 11491 Sunset Hills Road, Reston VA 20190-5280 Tel: 703-471-6870 Fax: 703-471-4237 http://www.hunterlab.com. Standard plate Sandard Hunter White Tile Source: Hunter Color. [0044] Equipment Preparation [0045] 1. Assure that the Spectrophotometer is configured as follows: Illumination Type C Standard Observer   2° Geometry 45/0° Measurement angle Port Diameter 0.70 inch Viewing area 0.50 inch (and no smaller) UV Filter: Nominal [0046] 2. Calibrate the spectrophotometer using standard black and white tiles supplied with the instrument according to manufacturer's instructions before beginning any testing. [0047] Sample Preparation [0048] 1. Unwrap, unfolded and lay the product or pad samples flat without touching or altering the color of the body facing surface. [0049] 2. Areas on the body-facing surface of the product should be selected for measurement and must include the following: [0050] The non-colored portion of the topsheet. [0051] The colored portion of the topsheet; including the two or more shaded portions. [0052] Any other portions of the topsheet above the absorbent core having a visibly or measurably different color from the first shaded zone. Embossed channels and folds should not be included in zones of measurement as they may skew the proper results. Measurements should not be made overlapping the border of two shaded portions. [0053] Test Procedure [0054] 1. Operate the Hunter Colorimeter according to the instrument manufacturer's instructions. [0055] 2. Pads should be measured laying flat over the 0.70 inch aperture on the instrument. A white tile should be placed behind the pad. [0056] 3. The pad should be placed with its long direction perpendicular to the instrument. [0057] 4. Measure the same zones selected above for at least 3 replicate samples. [0058] Calculation Reporting [0059] 1. Ensure that the reported results are really CIE L*,a*,b*. [0060] 2. Record the L*,a*,b* values to the nearest 0.1 units. [0061] 3. Take the average L*, a*, b* for each zone measured. [0062] 4. Calculate ΔE* between different shaded portions and ΔE* between each shaded portion and the non-colored portion where the non-colored portion exists. [0063] Human Sensitivity to Light [0064] The human sensitivity threshold for the lightness of a dark green color is a ΔE* of about 1.0. For a dark green color, if only the a* and b* change, human sensitivity is a ΔE* of 2.4. In the context of an absorbent article herein (e.g., a sanitary napkin) it is highly likely that many people would not see a color difference if the ΔE* is less than 2. This sensitivity is described in the following reference: “The Measurement of Appearance”, by Hunter and Harold, 2nd edition, 1987, (ISBN 0-471-83006-2). [0065] Chapter 4 of Hunter's book describes human color sensing and chapter 9 is about color scales. By making side-by side comparison, humans can differentiate up to 5 to 10 million different colors. In the 1940s, a researcher named MacAdam did human chromaticity discrimination experiments. He found the thresholds of sensitivity and showed these depend on the color. Later work by Brown and MacAdam came up with a logarithmic lightness dimension scale for human sensitivity to go with the earlier color scale. Based on the reduction to practice of the invention, experimentation and the foregoing work by Brown and MacAdam, it has been found herein that a ΔE≧3.5 is the preferred range to effect proper differentiation between the shades that provides the proper appearance of depth. However, where the ΔE is as small as about 1 and still operates to provide a perception of depth between the shades, this ΔE is also contemplated and included herein. An example where ΔE may be between at last two shades of one or more colors may be found in an alternative embodiment that provides a multi-color and/or shade gradient of a color across the viewing surface of the absorbent article. CHART I Sample Number Topsheet Type Colored Options ΔE* 23 ΔE* 12 ΔE* 13 1 Formed Film Two-tone inner/outer 6.10 10.83 16.86 color 2 Formed Film One-tone color 0.25 8.60 8.80 3 Non-woven One-tone color 0.22 10.63 10.81 4 Non-woven Two-tone inner/outer 5.98 11.03 16.92 color 5 Formed Film Two-tone light outer 10.01 2.88 12.80 color/inner dark color 6 Formed Film Two-tone medium outer 7.51 6.37 13.61 color/inner dark color 7 Formed Film Two-tone darker outer 5.60 19.16 14.22 color/inner dark color 8 Formed Film Two-tone (secondary 4.58 6.00 8.06 topsheet colored outer color)/(core colored dark color) 9 Formed Film One-tone outer color 0.21 8.90 8.84 [0066] As has been noted previously, the difference in color between the first shade and the second shade should be at least 3.5. The difference in color between the first shade and the non-colored portion is at least 6. The difference in color between the second shade and the non-colored portion is at least 3.5. Through experimentation and reduction to practice of the invention, it has been determined that the preferred creation of depth perception happens at about and above these set parameters. For products substantially not having a non-colored portion within the measurement zone (i.e., a gradient or fully colored product), the above criteria for the shaded portions (i.e., ΔE*≧3.5) remains the preferred standard. [0067] Chart I above clearly shows the ΔE*s obtained between multi-tone (e.g., two tone) and single tone signals. Formed films and nonwovens useful for the invention herein are those which will allow the sufficient penetration of light therethrough such that the shaded portions may be clearly discerned and such that such discernment produces the depth perception effect. The color may be any suitable color fitting within the parameters herein for ΔE* between colored portions and non-colored portion (where it exists). For example, the colors green, blue, red, yellow, orange, purple and any other color within the color spectrum are suitable for the purposes described herein. [0068] Sample Nos. 1 and 2 are clearly distinct in their ΔE* 23 . Specifically, the ΔE* 23 (which is 6.10) is greater than 3.5. This ΔE 23 indicates that there is a perceptible difference in color or lightness/darkness between the two points of measurement; i.e., between the second shaded portion and the non-colored (or white) portion (see FIG. 4). As noted above for human perception, Sample No. 2's ΔE*23 of 0.25 would not be perceptible to the human eye. This indicates that the signal is only a one or single tone signal (i.e., color portion). [0069] All documents cited in the Detailed Description of the Invention are, are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention. [0070] While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a coin operated redemption game played on a low friction, air cushion playing surface and including a moveable barrier for capturing a puck after play of the game has finished. 2. Description of Related Art The game of "Air Hockey™" is a well known, two player game and is described in the prior art literature and in U.S. Pat. Nos. such as 3,773,325 and 3,887,187. Two players are typically located at opposite ends of a playing surface which includes an array of small holes through which pressurized air is pumped. A puck, in the form of a flat disk, can float over the cushion of air with relatively little or no friction. A striker or a mallet is used to hit the puck. The players at opposite ends of the playing surface attempt to defend their goal from the puck driven by their opponent. While the use of two player air cushion games is fairly well known, its implementation as a one player game, especially in the context of coin operated machines, is relatively limited. In that regard, U.S. Pat. No. 5,110,128 entitled "AIR CUSHION TABLE GAME", discloses a one player, coin operated game for use in conventional game or redemption arcades. The player uses a mallet to hit a puck which is driven over an air cushion surface to impact targets at the goal end of the playing surface. A barrier is employed to come down at the end of the game. The barrier includes a flexible rubber blade which permits the puck to slip under it so it does not return to the player. The play of the game can be made more challenging by placing an obstacle in front of the targets. While this approach has many advantages, it has disadvantages too. For example, a rubber blade is subject to wear and oxidation. Moreover, the excitement in the play of the game can diminish in view of the fact that the rebound "action" of the puck is not believed to be very quick. Isolated, but possibly relevant concepts, can be found in other contexts. For example, U.S. Pat. No. 4,173,341 describes an air cushion game, similar to pin ball, including a display scoring mechanism at the far end. Also, U.S. Pat. No. 3,970,310 describes an electrically operated game in which targets may be randomly illuminated for a limited period of time during which the player attempts to hit the illuminated target with a projectile. U.S. Pat. No. 5,222,737 describes a puck style surface projectile game having a board display above the surface. The following patents describe amusement games including scoring displays of possible relevance: 1,986,152; 1,906,260; 2,914,327; 3,275,324; 3,384,375; 3,063,719; and 5,071,127. Insofar as is known and understood, none of the prior art, either taken individually or in combination, teaches or suggests a single player, air cushion game including a resilient barrier that moves up in order to capture the puck at the end of the game. SUMMARY OF THE INVENTION Briefly described, the invention comprises a one player, air cushion game. The player initially puts a coin or token into the apparatus and the machine delivers a puck to the player. The player has 25 seconds, which may be increased or decreased and is controlled by a timer mechanism, to make as many points as possible. The player makes points by hitting the puck with a striker so that it glides down the playing surface and hits a target at the other end. According to the preferred embodiment of the invention, there are four targets at the far, or goal, end of the playing surface that can be hit during the adjustable 25 second play of the game. At the beginning of the game, a barrier gate comes down at the far end behind the target areas. Each of the four target areas is illuminated by a white light. Four green lights located above the four illuminated spots help the player locate the four target areas. The player earns points by driving the puck over one of the four illuminated target areas during the adjustable 25 second play of game. The puck is detected as it passes over one of the four illuminated target areas by an LED/photosensor combination located between it and the resilient barrier. According to an alternative embodiment, there might be three targets each illuminated by a pair of red and green lights. If the player hits one of the targets illuminated by a green light, the player gets a positive score, but if the target is illuminated by a red light, the player gets a negative score. The total cumulative score is recorded on a volcano-like simulation display on the scoreboard at the goal end of the playing surface. The simulated volcano includes a plurality of successive scoring fields or bands, with the lower scoring field being located at the bottom closer to the target area of the playing surface. The object of the game is to increase the cumulative score in order to reach the top of the volcano thereby indicating the attainment of the maximum cumulative points possible. Each of the successive scoring fields include behind it a string of between one and four strings of lights which light up the scoring field in front of it. According to an alternative embodiment of the invention, the value of the targets can change randomly, as indicated by the illumination of red or green lights, so that one, two or three targets can be either green or red colored at any given time. The score can also be doubled up or down by hitting one of two targets located on the two opposite sides of the playing surface during play. The score is kept on the vertical, volcano-like scoreboard. The player starts at the bottom in a blue band or scoring field and advances upward through the band. The player subsequently makes it to the pink band or field, then the red band, etc. until the player makes it all the way to the yellow zone or band at the top. As the player proceeds up the volcano, sound and light effects become progressively more vigorous and exciting. If the player makes it to the top of the volcano, the volcano erupts. Prizes are typically in the form of tickets which may be redeemed for real prizes later. Alternatively, the prizes may be dispensed in the form of a packet with a special prize inside. At the end of the adjustable 25 second game, the gate at the far end goes up which permits the puck to slip through the far end and become captured until the next player comes and places a coin or token into the machine. The puck is then released and returned back to the player. Another feature of the invention is that if the player puts a coin or token into the machine within seven seconds, which can be adjusted to increase or decrease, after the end of play of the first game, then the player can continue to play the second game from where he or she left off during the previous 25 seconds. If, however, more than seven seconds elapse from the end of the first game, then the player starts the second game at the very bottom of the volcano. These and other features of the invention may be more fully understood by reference to the following drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front, perspective view of the improved one player, air cushion table game according to the preferred embodiment of the invention. FIG. 2A is an electrical schematic describing the electronics which control the game illustrated in FIG. 1. FIG. 2B is an electrical schematic describing in further detail the microprocessor sub-assembly illustrated in FIG. 2A. FIG. 3A illustrates the deflector bar in its first, or down, position where it is located during the play of the game. FIG. 3B illustrates the deflector bar in its second, or up, position at the end of the game so that the puck can pass under it. FIG. 3C is a detail view of the drive mechanism for the deflector bar illustrated in FIGS. 3A and 3B. FIG. 4A illustrates the volcano scoreboard display at the beginning of the game. FIG. 4B illustrates the volcano scoreboard display at the end of the game after a player has accumulated the maximum possible score. FIG. 5 is a detailed view of one of the four target areas of the preferred embodiment of the invention. FIG. 6 is a front, perspective view of an alternative embodiment of the one player, air cushion table game, which includes a mechanism for randomizing the value and scoring of three targets during play of the game. FIG. 7A illustrates the three targets of the alternative embodiment of the invention as illuminated by three separate pairs of red and green lights respectively. FIG. 7B is a detail view illustrating a single pair of red and green lights according to the alternative embodiment of the invention as they illuminate a single target at the goal end of the playing surface. FIG. 8 is a rear view of the invention with the back panel removed illustrating the puck collecting bin which includes a sloping floor and the puck return chute which received the puck from the bin. FIG. 9 is a front view of the invention with the access door open revealing the coin mechanism, the ticket dispenser and the prize dispenser. FIG. 10 is a detail view of the solenoid operated puck control end at the bottom of the puck delivery chute. DETAILED DESCRIPTION OF THE INVENTION During the course of this description like numbers will be used to indicate like elements according to the different figures that illustrate the invention. The preferred embodiment of the improved one player, air cushion table game apparatus 10 is illustrated in FIG. 1. The game 10 is housed in a console 12. Console 12 includes a lower portion 11 connected to an upper portion 13 by a hinge 99 which permits the upper portion 13 to be folded over and on top of lower portion 11 for shipping. The primary exterior features of the game apparatus 10 are a playing surface 14 and a scoreboard 16. The playing surface 14 has a goal or target end 40, two sides 42 and a player end 38. A display in the form of a simulated volcano 18 located above a platform or shelf 17 provides a visual indication of the cumulative score of the player and, therefore, an indication of the progress of the game. The game is initiated when a player places a coin or token into the coin slot 20. That activates coin mechanism 21 which turns on microprocessor sub-assembly 56 that includes an electronic timing mechanism incorporated in an electronic controller 54, both illustrated in the electrical schematic of FIG. 2A. The microprocessor sub-assembly 56 is substantially identical to the sub-assembly in the commercially available game called "Home Run Hitter" available from Coin Concepts, Inc. of East Brunswick, N.J. Air, propelled by a blower 78, is forced through small air holes 26 in the playing surface 14. A strikeable projectile, in the form of a flat disc, or puck 22, is released to the player at the beginning of the game. Puck 22 is struck with a striker 24, or mallet in the conventional manner. A hard, clear plastic sheet 23 keeps the player from coming too close to the goal end 40 of the playing surface during play of the game. According to the preferred embodiment 10 of the invention, a barrier gate, or boom 46, always remains in an up, or second position 50, prior to the play of the game as shown in FIG. 3B. After play of the game is initiated by the player placing a coin or token into the coin slot 20, the electronic controller circuit 54 causes the microprocessor sub-assembly 56 to signal the barrier gate motor 52 to turn. Puck gate motor 52 includes a drive crank 96 and a spring link 98 which is connected to the top of the barrier gate 46 as shown in FIGS. 3A, 3B and 3C. Rotation of the crank 96 and link 98 causes the gate 46 to descend to a first, or down position 48 at the beginning of the game as shown in FIG. 3A. Barrier gate 46 includes a resilient bumper strip 94 on the vertical face thereof which actively reflects the puck 22 back to the player during play. This is very important because the resilient play of the game makes the game faster and exciting for the player. Barrier 46 is connected by a hinge 92 to the back of the upper section 13 of the console 12 so that it can rotate selectively between its first, or down position 48 and its second, or up position 50. At the end of the 25 second play of the game which time period may be adjusted, and as indicated by game timer display 44, the barrier gate 46 moves up to its second position 50. This creates an opening under the barrier 46 to permit the puck 22 to pass thereunder. When that happens the puck 22 drops into a bin 88 directly behind the goal end 40 of the playing surface 14 which delivers it to inclined puck chute 86. Puck collection bin 88 includes an inclined base or sloping floor 89 illustrated in detail in FIG. 8. Puck 22 then rolls down the puck chute 86 to a solenoid operated puck release gate mechanism 90. Solenoid operated puck release gate mechanism 90 includes two portions of a fork-like mechanism that selectively deliver a puck 22 to a player at the beginning of the game while at the same time setting up a second puck 22 for delivery to the next player. A small puck stop 87 located at the end of puck chute 86 prevents the puck 22 from rolling out onto the floor. As previously described, however, if the player places a coin or token in the coin slot 20 thereby activating the coin mechanism within seven seconds of the end of the first game, the player can continue to score from the point where he or she stopped in the first game. If, however, the player waits for more than seven seconds, then the player must start from the very beginning at the very lowest band 68 on the volcano 18. The barrier gate 46 remains in the first, or down position 48 during the 25 second play of the game (or its extension). After the game is over the barrier gate 46 moves back to its second, or up position 50, until such time as play is reinitiated by placing another coin or token in coin slot 20. The electronic controller mechanism 54, illustrated in FIG. 2A controls the electronic components that in turn control the preferred embodiment of the invention 10. Placing a coin or token in coin slot 20, activates the coin mechanism 21, which in turn activates the electronic microprocessor sub-assembly and timer 56. The electronic microprocessor sub-assembly and timer 56, described in further detail in FIG. 2B, is substantially identical to the controller and timer used in a commercially available game known as "HOME RUN HITTER" sold by Coin Concepts, Inc. of East Brunswick, N.J., as previously mentioned. Activation of microprocessor sub-assembly 56 turns on the air supply blower 78 and releases a puck 22 by activating the puck release solenoid gate 90. Simultaneously, the digital display 44 indicates that 25 seconds are available for play of the game. The controller circuit 54 and its associated elements are powered by a 120 volt AC power supply 53 in a conventional manner. The player plays the game for an adjustable 25 second period and his or her score is recorded on the volcano ladder-like scoring indicator 18. At the end of the game, the player receives a ticket from ticket dispenser 80 or a prize that slides down prize chute 84 from prize dispenser 82 shown in FIG. 9 depending upon the set-up of the game. Prior to play of the game the barrier gate 46 is in its second, or up, position 50 shown in FIG. 3B. During the adjustable 25 second play of the game the barrier gate 46 is in its first or down position 48 shown in FIG. 3A. If, within seven seconds of the end of the adjustable 25 second play of the first game, the player places another coin or token into the coin slot 20, then play of the second game resumes from where the player had left off in the first game. If, however, the player did not place a coin or token into the coin slot 20 during the seven second grace period after the 25 second play of the first game, then the player starts the play of the second game from the very beginning at the bottom band or scoring field 68. After play of the game is over, the microprocessor sub-assembly 56 causes the puck gate motor 52 to drive the barrier gate 46 into its second, or up, position 50 thereby permitting the puck 22 to be collected in bin 88, and returned down the puck shoot 86 to the puck release gate and solenoid mechanism 90. The microprocessor sub-assembly 56 totals up the number of "hits" that a player makes as the puck 22 passes over the four illuminated target areas 27. The target areas 27 are illuminated by a commercially available light or lamp 33 as shown in FIG. 5. Each time a puck 22 passes over one of the four illuminated target areas 27, it interrupts a light beam from a commercially available LED/photosensor combination unit 29 which, in turn, records a score on the volcano 18. A green light 31, preferably located in front of each of the illuminated target areas 27, indicates to the player where the target areas 27 are located. A speaker 19 driven by commercially available sound card technology in microprocessor sub-assembly 56 provides suitable audio sound effects appropriate for any particular stage of the game. According to an alternative embodiment of the invention 100, instead of having four illuminated target areas 27, the targets may comprise three target areas 28, 30 and 32 which are each illuminated with pairs of red and green lights 58, 60 and 62 as shown in FIGS. 7A and 7B. A green light 58a, 60a and 62a indicates that the value of the target area 27 is positive whereas a red light 58b, 60b and 62b indicates that the value of the target area 27 is negative. If one of the side targets 34 or 36 located on either side 42 of playing surface 14 as shown in FIG. 6, is struck during the play of the game, then the value of the targets 28, 30 and 32 doubles. A randomizer 64 driven by the microprocessor sub-assembly 56, according to techniques and software that are well known to those of ordinary skill in the art, can change the value of the targets 28, 30 and 32 as indicated by their red or green illumination. One of the very useful features of the present invention 10 and 100 is that the upper section 13 of the console 12 is connected by a hinge 99 to lower section 11 of the console 12. This permits the upper section 13 of the console 12 to be rotated downwardly onto the lower section 11 so that the entire invention 10 or 100 can be shipped as a single unit. FIG. 5 illustrates in detail one of the four illuminated target areas 27 according to the preferred embodiment 10 of the invention. A green light 31 indicates to the player the approximate location of the illuminated target areas 27. A conventional, commercial available LED/photosensor combination unit 29 located directly behind the illuminated target area 27 but ahead of the resilient barrier gate 46, senses the presence of the puck 22 during the adjustable 25 second play of the game. FIG. 6 illustrates an alternative embodiment of the invention 100 which includes, as previously described, three targets switches 28, 30 and 32 whose values may randomly or pseudo randomly change during the game. As illustrated in FIGS. 7A and 7B, target 28 is illuminated by a pair 58 of green 58a and red 58b lights. Similarly, targets 30 and 32 are illuminated by a pair 60, 62 of green 60a, 62a or red 60b, 62b lights, respectively. Whether a green light 58a, 60a, 62a or a red light 58b, 60b, or 62b is illuminated depends upon the signal from the randomizer 64 in the microprocessor sub-assembly 56. It is possible for all three targets 28, 30 or 32 to be illuminated red, or green, or any combination of red or green depending upon the signals provided to light pairs 58, 60 and 62. The volcano-like simulation 18 on the scoreboard 16 indicates the cumulative score achieved by a player during the adjustable 25 second play of the game. The volcano simulation 18 includes a plurality of multiple, progressive scoring fields, 3 zones or bands 68, 70, 72, 74, etc. The lowest scoring field, preferably colored blue, is field 68. If the player achieves the cumulative value greater than that indicated in the lower field 68, then he or she progresses onto the next field 70. The lower field might, for example, be blue, the next field 70 might, for example, be pink, the next 72 might be red, and so on, and the top 74 might be yellow. Each of the progressive fields 64-72 is illuminated between one and four light strings 76. For example, the bottom, or blue, field 68 might include four strings of light 76 which progressively light as through the field 68. The next field, i.e., the pink field 70, might include, for example, three strings of lights 76. The object of the game, is to get to the top of the volcano before the game 10 or 100 times out, if possible. The player receives a ticket or a prize depending upon the cumulative score he or she has received. Again, as previously described, the player has the option of picking up where he or she left off at the end of the first game, if he or she places a coin or token in the coin slot 20 within an adjustable seven second grace period at the end of the 25 second play of the first game. According to the alternative embodiment of the invention 100, if a player strikes a target 28, 30 or 32 that is green during play, then the cumulative score moves upward. If, however, a target 28, 30 or 32 is struck while it is illuminated with a red light, then the cumulative score decreases and the player may actually find himself or herself moving down the scoring fields 68, 70, 72 or 74 that comprise the volcano-like simulation 18. If a player strikes one of the side targets 34 or 36 during the play of the game, the value of the illuminated targets 28, 30 or 32 double. At the end of the game, the player receives a prize. The prize may be in the form of tickets delivered by ticket dispenser 80 or might be in the form of a packet including a small premium therein. The packets are released by prize dispenser 82 and roll down chute 84 to the player as shown in FIG. 9. The invention has several advantages over those known in the art. First, it can be played by one person. Second, the barrier gate mechanism is especially functional and rugged, thereby permitting the game to be played in an unsupervised location for extended periods of time without additional maintenance. Also, the resilience of the gate causes the puck to return quickly and makes the game harder and more interesting to play. Third, because many people are familiar with prior art, two player air hockey games, the game is relatively easy to learn and relatively easy to play, even though scoring can be very challenging. Fourth, the alternative embodiment is exciting to play especially due to the randomized nature of the strikeable target and its interaction with a progressive series of scoring fields. While the invention has been described with reference to a preferred embodiment thereof, it will be appreciated by those of ordinary skill in the art that modifications can be made to the structure and play of the game without departing from the spirit and scope of the invention as a whole.

1a

BACKGROUND OF THE INVENTION The present invention relates to a phase-contrast haploscope used to examine various functions of binocular vision, i.e. subjective angle of squint, retinal correspondence, fusion faculty, subjective vision, suppression, aniseikonia, circumflex deviation and others, by separating images of right and left eyes in environment most similar to ordinary vision. According to The Medical Dictionary issued by Nanzando Co., Ltd., a haploscope is an optic axis measuring instrument, which forms images of two separate targets which are similar to or identical to each other on both eyegrounds using a prism or reflecting mirror for uniting the images by the capability of binocular vision and examines fusion power, fusional motion, and the relation between adaptation control and convergence from the capability of binocular vision. As shown in FIG. 12, in a conventional synchronous type phase-contrast haploscope which has been practically used, targets g, h of eyes are separated by using a pair of sectors a, b which correspond to right and left eyes and which rotate at a high speed in front of eyes with an inter-hole phase difference of 90 degrees and a pair of right- and left-hand projectors e, f having sectors c, d which are synchronized with the sectors a, b, respectively (an image projected by the right-hand projector e is seen only by the right eye, and an image projected by the left-hand projector f is seen only by the left eye). In the FIGS., i to l denote rotating motors, m denotes the plane of projection, n and o denote left- and right-hand lantern slides, p denotes an examinee, and q and r denote left- and right-hand projecting beams. Because of a rotating speed (100-120 c/s) higher than a critical fusion frequency, in a subjective sense, both targets g, h are recognized continuously and concurrently. By using such apparatus, it is possible to examine said various functions of binocular vision under conditions quite similar to ordinary vision. On the other hand, there exists a liquid crystal phase-contrast haploscope. The flashing frequency of an image can range from 0.1 to 50 c/s by using liquid crystal shutters which are synchronized with changeover shutters for both eyes. Also, the liquid crystal shutter has an opening/closing characteristic which provides an operation speed up to 50 c/s with a rise/fall time of 5 ms. SUMMARY OF THE INVENTION In said conventional synchronous type phase-contrast haploscope, however, it is necessary to synchronously drive expensive rotating motors i-l corresponding to a total of four sectors a-d, i.e. a pair of sectors a, b corresponding to right and left eyes and a pair of sectors c, d corresponding to projectors e, f. This is technically difficult to achieve, and a repeated use over a long period of time causes an out-of-step, condition which is fatal in use. Hence, adjustment for synchronization is needed on occurrence of the out-of-step condition. This is quite troublesome. On the other hand, in the conventional liquid crystal phase-contrast haploscope, a group of changeover switches must be turned on/off at a high speed for synchronously changing a total of four shutters, i.e. a pair of changeover shutters corresponding to left and right eyes and left- and right-hand liquid crystal shutters. As a result, a chattering phenomenon occurs, causing the mechanical service life of the group of changeover switches to shorten and the frequency of fault occurrence to increase. Moreover, there is a limit to high-speed changeover, and changeover noise occurs frequently. In view of the foregoing, major objects of the present invention to be achieved are described below. A first object of the present invention is to provide a rotary disc for use with a phase-contrast haploscope which is compact, small-scaled and smaller in the number of parts and to provide such a phase-contrast haploscope. A second object of the present invention is to provide a rotary disc for use with a phase-contrast haploscope which uses a single motor for high-speed changeover without synchronizing a driving portion and to provide such a phase-contrast haploscope. A third object of the present invention is to provide a rotary disc for use with a phase-contrast haploscope which operates quietly and is highly durable and to provide such a phase-contrast haploscope. A fourth object of the present invention is to provide a phase-contrast haploscope which is mobile. A fifth object of the present invention is to provide a phase-contrast haploscope in which the vertical position can be set according to the sitting height of an examinee. A sixth object of the present invention is to provide a phase-contrast haploscope in which a face setting position can be adjusted according to an individual difference in face profile irrespective of age or sex of examinees. A seventh object of the present invention is to provide a phase-contrast haploscope in which the size of left- and right-hand targets projected on a plane of projection can be changed. An eighth object of the present invention is to provide a phase-contrast haploscope in which left- and right-hand targets projected on a plane of projection can be moved vertically and horizontally. A ninth object of the present invention is to provide a phase-contrast haploscope in which the rotational speed of a driving motor and left- and right-hand illuminances can be regulated. A tenth object of the present invention is to provide a phase-contrast haploscope in which optical fibers and transmitting optical fibers can be run and arranged neatly. Other objectives of the present invention will be apparent from the specification, drawings, and particularly from the scope of the appended claims. The above-described objects are achieved by the following novel features of the present invention. In the first aspect of the present invention, there is provided a rotary disc for a phase-contrast haploscope which is driven by a motor and which is rotatably mounted on a stationary front plate having a pair of left- and right-hand look-through holes formed therein at positions facing both left and right eyes, leaving a predetermined clearance between the rotary disc and the front plate, wherein through holes which sweep out a concentric circular path and pass in front of said left- and right-hand look-through holes in sequence at a high rotational speed in such a manner as to instantaneously coincide with the look-through holes are formed on the concentric circular path, project-through holes are formed on a concentric circular path having a different diameter from that of said through holes at corresponding positions, each of said project-through holes allowing the passage of a projecting beam for projecting a target which is seen through said left-hand look-through hole and said through hole when the left-hand look-through hole and the through hole coincide with each other, and on the other hand, project-through holes are formed on a concentric circular path having a different diameter from those of said through holes and said project-through holes at corresponding positions, said project-through hole allowing the passage of a projecting beam for projecting a target which is seen through said right-hand look-through hole and said through hole when the right-hand look-through hole and the through hole coincide with each other. In the second aspect of the present invention, there is provided a rotary disc for a phase-contrast haploscope, wherein the through holes and the project-through holes in the first aspect are formed on respective concentric circular paths spaced equally. In the third aspect of the present invention, there is provided a rotary disc for a phase-contrast haploscope, wherein the through holes and the project-through holes in the first aspect are respectively arranged with an inter-hole phase difference of 90 degrees in a circumferential direction. In the fourth aspect of the present invention, there is provided a rotary disc for a phase-contrast haploscope, wherein the left- and right-hand look-through holes and the through holes in the first or second aspect are shaped in a large circle having the same size, and the project-through holes are shaped in a rectangular arc. In the fifth aspect of the present invention, there is provided a rotary disc for a phase-contrast haploscope, wherein the target in the first, second, third or fourth aspect comprises a character, a graphic pattern, a symbol or a combination thereof, or other images. In the sixth aspect of the present invention, there is provided a phase-contrast haploscope which includes a disc case which has a front plate having a pair of left- and right-hand look-through holes in its lower half portion and a rear plate having a through window or left- and right-hand through holes formed in its lower half portion, wherein a pair of left- and right-hand beam emitting holes and beam incident holes corresponding to the left- and right-hand look-through holes are formed respectively in the front plate and in the rear plate at desired opposed positions, and which contains a motor driven rotary disc in a rotatable manner, the rotary disc having through holes and project-through holes formed therein, the through holes and project-through holes sweeping out respective concentric circular paths of different diameters and passing at a high rotational speed between said left- and right-hand look-through holes and said through window or left- and right-hand through holes, opposed to each other, and between said left- and right-hand beam emitting holes and left- and right-hand beam incident holes, opposed to each other, in such a manner as to instantaneously coincide with corresponding holes and the window, and left- and right-hand projectors into which slide loaders allowing a slide to be inserted thereinto and removed therefrom are incorporated and which takes in beams from said beam incident holes, irradiates the slides with the beams through appropriate beam transmitting means and projects projecting beams having passed through onto the plane of projection. In the seventh aspect of the present invention, there is provided a phase-contrast haploscope, wherein the disc case and projectors in the sixth aspect are mounted on a base which is raised and lowered for positioning. In the eighth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the disc case in the seventh aspect is mounted on a gantry stand or left- and right-hand parallel support stands standing on the base, which left- and right-hand parallel support stands are accompanied by left- and right-hand parallel guide uprights standing in front of them. In the ninth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the base in the seventh or eighth aspect is supported on a mobile lifter support. In the tenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the front plate in the sixth, seventh, eighth or ninth aspect is provided with a forehead rest fixed to the end of a slide rod which is slidably inserted into a guide cylinder for positioning and adjustment, and the guide cylinder is mounted on the front plate above the middle between the left- and right-hand look-through holes. In the eleventh aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand look-through holes in the sixth, seventh, eighth, ninth or tenth aspect are provided with transparent plates which are attached thereto by appropriate means. In the twelfth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand beam emitting holes in the sixth, seventh, eighth, ninth, tenth or eleventh aspect are provided with connectors which are attached to their outer ends, and the beam emitting ends of the left- and right-hand optical fibers, which are respectively connected to light source boxes fixed to the lower surface of the base at the lateral sides thereof in a hanging manner, are allowed to be inserted into and fixed to the connectors. In the thirteenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand beam emitting holes in the sixth, seventh, eighth, ninth, tenth or eleventh aspect are provided with sockets which are connected with a power cord and into which halogen lamps are screwed. In the fourteenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand beam incident holes in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth or thirteenth aspect are provided with connectors which are attached to their outer ends, and the beam incident ends of left- and right-hand transmitting optical fibers are allowed to be inserted into and fixed to the connectors. In the fifteenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the rear plate in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth or fourteenth is provided with a motor which is mounted on its outer face, and a motor shaft to which the rotary disc is attached penetrates the rear plate inwardly. In the sixteenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the base in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth or fifteenth aspect is provided with a control box which is attached to its one end in a hanging manner. In the seventeen aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand projectors in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth or sixteenth aspect are provided with zooms which are integrally incorporated into the forward ends of the projectors. In the eighteenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand projectors in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth or seventeenth aspect are provided with connectors which are integrally incorporated into the rear ends of the projectors, and the beam irradiating ends of the left- and right-hand transmitting optical fibers are allowed to be inserted into and fixed to the connectors. In the nineteenth aspect of the present invention, there is provided a phase-contrast haploscope, wherein each of the left- and right-hand projectors in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth or eighteenth aspect, is pivoted between forked brackets in such a manner that a vertical angle is adjustable using operating means of the forked brackets, which forked brackets are mounted on the top ends of left- and right-hand support stands standing on the base in such a manner as to be horizontally swingable using the operating means. In the twentieth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the operating means in the nineteenth aspect, includes an equilibrating tension spring one end of which is attached to the front end of an auxiliary plate attached to the bottom side of a projector and the other end of which is attached to a forked bracket base coupling portion, thereby always giving the behavior of lying down, and a handle which is attached to the rear end of the auxiliary plate and extends downward at right angles. In the twenty-first aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand projectors in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth or eighteen aspect upward penetrate the base with a predetermined spacing. In the twenty-second aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand projectors in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, eighteenth or twenty-first aspect include left- and right-hand seat rings which are rotatably mounted on the top ends of the projectors in such a manner as to cover left- and right-hand zooms, forked brackets which stand on the left- and right-hand seat rings in such a manner as to swing horizontally together with the seat rings by operation with operating means for horizontal and vertical swing movement, and left- and right-hand mirrors which are pivoted between forked brackets in such a manner that a vertical angle is adjustable using the operating means for horizontal and vertical swing movement and as to face the top ends of the left- and right-hand zooms. In the twenty-third aspect of the present invention, there is provided a phase-contrast haploscope, wherein the operating means for horizontal and vertical swing movement in the twenty-second aspect is a pair of left- and right-hand right-angle handles which are fixed to the inner sides of the left- and right-hand arms which obliquely downward project from and are located at the middle portions of the back sides of the left- and right-hand mirrors. In the twenty-fourth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the gantry stand in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, eighteenth or nineteenth aspect include a chin rest which is fixed in a manner capable of rising or lowering for positioning to the end portion of a crank bracket, whose base end is fixed on the bottom face of the top plate of the gantry stand below the middle between the left- and right-hand look-through holes. In the twenty-fifth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the left- and right-hand parallel guide uprights in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, eighteenth, nineteenth, twenties or twenty-first aspect include a cross-plate which bears a chin rest at its central portion corresponding to the middle between the left- and right-hand look-through holes and which stretches between the left- and right-hand parallel guide uprights in such a manner that its both ends can slide up and down along the parallel guide uprights for positioning. In the twenty-sixth aspect of the present invention, there is provided a phase-contrast haploscope, wherein the intermediate portions of left- and right-hand optical fibers and left- and right-hand transmitting optical fibers in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, eighteenth, nineteenth, twenties or twenty-fourth aspect pass through left- and right-hand auxiliary cases which stand on the gantry stand on both sides thereof so as to support the sides of the disc case, and the intermediate portions of the left- and right-hand optical fibers also pass through the left- and right-hand supports of the gantry stand. In the twenty-seventh aspect of the present invention, there is provided a phase-contrast haploscope, wherein the intermediate portions of the left- and right-hand optical fibers and left- and right-hand transmitting optical fibers in the sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, eighteenth, nineteenth, twenties, twenty-first, twenty-second, twenty-third or twenty-fifth aspect pass through the left- and right-hand support stands. In the present invention having the above-described novel means, a single rotary disc is used to change over left- and right-hand targets projected on a plane of projection corresponding to left- and right-hand look-through holes synchronously with the changeover of the left- and right-hand look-through holes. As a result, apparatus according to the present invention is compact, small-scaled, and mobile to any location provided with a power source and does not occupy much space. Moreover, a base can be raised and lowered. In addition, the apparatus is adjustable to meet the physique and face profile of an examinee by adjusting; the position of a forehead rest and chin rest. Hence, a common apparatus can be used for examination irrespective of age or sex. Various kinds of examinations can be securely performed by regulating the changeover speed of the synchronized left- and right-hand look-through holes and left- and right-hand projected targets by changing a motor speed from a control panel on a control box and thus increasing/decreasing the number of revolutions of a rotary disc, by individually adjusting the illuminance of the left- and right-hand projected targets, by zooming left- and right-hand projectors to individually zoom out or in the left- and right-hand projected targets, and by swinging horizontally the left- and right-hand projectors and mirrors and adjusting the vertical angle thereof to individually move the left- and right-hand projected targets. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view showing a phase-contrast haploscope according to a first embodiment of the present invention; FIG. 2 is a rear view of the haploscope according to the first embodiment; FIG. 3 is a right-hand side view of the haploscope according to the first embodiment; FIG. 4 is an enlarged plan view showing a control box of the haploscope according to the first embodiment; FIG. 5 is an enlarged front view showing an embodiment of a rotary disc according to the present invention; FIG. 6 is a partially omitted perspective front view showing a disc case with its front plate removed; FIG. 7 is a view showing a case where a halogen lamp is attached to a beam emitting hole formed in the rear plate of the disc case; FIG. 8 is an enlarged front view showing another embodiment of a rotary disc according to the present invention; FIG. 9 is an enlarged front view showing still another embodiment of a rotary disc according to the present invention; FIG. 10 is a front view showing essential portions of a phase-contrast haploscope according to a second embodiment of the present invention; FIG. 11 is a right-hand side view showing essential portions of the haploscope according to the second embodiment; and FIG. 12 is an explanatory illustration showing examination with a synchronous type phase-contrast haploscope according to the prior art. DETAILED DESCRIPTION OF THE INVENTION A first embodiment of the present invention will be described with reference to drawings. FIG. 1 is a front view showing a phase-contrast haploscope according to the present embodiment. FIG. 2 is a rear view showing the haploscope. FIG. 3 is a right-hand side view showing the haploscope. FIG. 4 is a plan view showing a control box. FIG. 5 is an enlarged front view showing a rotary disc of the present embodiment. FIG. 6 is a partially omitted perspective front view showing a disc case with its stationary front plate removed. FIG. 7 is an enlarged plan view of essential portions of the disc case with its top plate removed when a halogen lamp is attached into a left-hand beam emitting hole. FIGS. 8 and 9 are enlarged plan views showing other examples of a rotary disc. In the figures, reference symbol A denotes a phase-contrast haploscope according to the present embodiment. B, B' and B" denote rotary discs used in the present embodiment. Reference numeral 1 denotes a disc case. 1a denotes a front plate, 1b denotes a rear plate, and 1c and 1d denote right- and left-hand side plates. Designators 2 and 3 denote a pair of circular left- and right-hand look-through holes which face left and right eyes, respectively, and which are formed in the front plate 1a at the center of its lower half portion. Designators 4 denotes a through window provided in the rear plate 1b at the lower half portion thereof. Designators 5a-5d denote through holes which have the same diameter as the left- and right-hand look-through holes 2, 3 and which are formed in the rotary disc B on concentric circular path α equally spaced at 90 degrees. Designators 6a-6d denote rectangular arc-shaped inner project-through holes which correspond to the left-hand look-through hole 2 and which are formed in the rotary disc B on concentric circular path γ equally spaced at 90 degrees. Designators 7a-7d denote rectangular arc-shaped outer project-through holes which correspond to the right-hand look-through hole 3 and which are formed in the rotary disc B on concentric circular path β equally spaced at 90 degrees. Designators 8 and 9 denote left-hand connectors which are coaxially mounted to a left-hand beam incident hole 10a and a left-hand beam emitting hole 10 at their outer ends. The holes 10a and 10 are formed in the front plate 1a and rear plate 1b at opposed positions where the holes face on one of inner project-through holes 6a-6d when one of through holes 5a-5d instantaneously coincides with the left look-through hole 2. The beam emitting end of a left-hand optical fiber 11 and the beam incident end of the left-hand transmitting optical fiber 12 are inserted into the left-hand connectors 8, 9 and fixed thereto with set screws 13, 14. Designators 15 and 16 denote right-hand connectors which are coaxially mounted to a right-hand beam incident hole 17a and a right-hand beam emitting hole 17 at their outer ends. The holes 17a and 17 are formed in the front plate 1a and rear plate 1b at opposed positions where the holes face on one of outer project-through holes 7a-7d when one of through holes 5a-5d instantaneously coincides with the right look-through hole 3. The beam emitting end of a right-hand optical fiber 18 and the beam incident end of a right-hand transmitting optical fiber 19 are inserted into the right-hand connectors 15, 16 and fixed thereto with set screws 20, 21. Reference Designator 22 denotes a variable speed motor mounted on the rear plate 1b at its center. The end of a motor shaft 22a extending through the rear plate 1b is fixed to the rotary disc B at its center. Reference Designator 23 denotes a forehead rest attached to a slide rod 23a which is inserted into a guide cylinder 24 mounted on the front plate 1a above the middle between the left- and right-hand look-through holes 2, 3. The slide rod 23a as an unillustrated guide groove extending along its upper edge, and the tip end of an adjusting set screw 25 is engaged with the guide groove for fixing. Designators 26 and 27 denote glass or plastic transparent plates stuck on left- and right-hand cylindrical frames 28, 29 whose stoppers 28a, 29a are mounted to the outer ends of the left- and right-hand look-through holes 2, 3, respectively. Designator 30 denotes a lift support standing upright at the center of a horizontally H-shaped base frame 31 equipped with casters 31a which can be locked. Designator 30a denotes a cylindrical support. 30b denotes a screw rod. 30c denotes a head portion which contains a known adjusting mechanism for raising and lowering the screw rod 30b inserted thereinto by turning a rotary handle 32 in a forward or reverse direction. Designator 32a denotes an adjusting stopper screw for fixing the screw rod 30b at an adjusted position. Reference designator 33 denotes a table type base and 34 and 35 denote left- and right-hand parallel support stands standing upright on the base 33 to support the disc case 1 thereon. Designators 36 and 37 denote left- and right-hand parallel uprights standing in front of the left- and right-hand parallel support stands 34, 35. Designator 38 denotes a cross-plate which bears a chin rest 38a at its central portion corresponding to the middle between the left- and right-hand look-through holes 2, 3 and which stretches between the left- and right-hand parallel guide uprights 36, 37 in such a manner that its both ends slide up and down along the uprights. Designator 39 denotes a cylindrical slider which is slidably fit onto the right-hand guide upright and which is fixed at an adjusted position with an adjusting set screw 40 in order to position the cross-plate 38 via a sleeve 39a. Designators 41a and 41b denote left- and right-hand light source boxes which are mounted on the bottom face of the base 33 at both sides thereof and to which beam incident ends of the left- and right-hand optical fibers 11, 18 are connected. Designator 42 denotes a control box attached to the right-hand end of the base 33 in a hanging manner with set screws 42a. Designators 43, 44, 45, 46 and 47 denote a main switch, a right-hand bright control, a left-hand bright control, a speed control, and a digital speedometer, respectively, arranged on a control panel 42b. Designators 48 and 49 denote a pair of left- and right-hand projectors which upward penetrate the base 33 with a predetermined spacing. Designators 50 and 51 denote left- and right-hand slide loaders which are incorporated into the left- and right-hand projectors 48, 49, respectively, at their top portions and which allow lantern slides n, o to be loaded thereinto or unloaded therefrom. Designators 52 and 53 denote a pair of left- and right-hand zooms which are mounted on the left- and right-hand projectors 48, 49, respectively, at their top ends. Designators 54 and 55 denote left- and right-hand connectors which are connected to the left- and right-hand projectors 48, 49, respectively, at their bottom ends and into which the beam irradiating ends of the left- and right-hand transmitting optical fibers 12, 19 are inserted and fixed with set screws 56, 57. Designators 58 and 59 denote a pair of left- and right-hand mirrors which are pivotally mounted in left-hand forked brackets 62 and right-hand forked brackets 63 with pivots 58a, 59a in such a manner that a vertical angle can be adjusted and set as desired and as to face the top ends of the left- and right-hand zooms 52, 53. The left- and right-hand forked brackets 62, 63 stand upright on the left- and right-hand seat rings 60, 61, respectively. The left- and right-hand seat rings 60, 61 are mounted rotatably on the top ends of the left- and right-hand projectors 48, 49 in such a manner as to cover the lower portions of the left- and right-hand zooms 52, 53. Designators 64 and 65 denote a pair of left- and right-hand right-angle handles for swinging the left- and right-hand mirrors 58, 59 horizontally and vertically. The handles 64, 65 are fixed to the inner neighboring sides of the left- and right-hand arms 66, 67 which obliquely downwardly project from and are located at the middle portions of the back surfaces of the left- and right-hand mirrors 58, 59. Designator 68 denotes a screw rod mounting hardware which is mounted on the bottom face of the base 33 at its center and into which the top end of the screw rod 30b is inserted to be fixed with a stopper screw 69. Designator 70 denotes a plug attached to the end of a power cord 71 extending from the control box 42. As illustrated with a dash-and-two dots line in FIG. 6 and shown in FIG. 7, the left- and right-hand beam emitting holes 10, 17 in the rear plate 1b may be enlarged to obtain left- and right-hand beam emitting holes 10', 17' having a larger diameter, and left- and right-hand halogen lamps 72, 73 may be inserted thereinto for attachment. In this case, electric cords (not shown) in place of the left- and right-hand optical fibers 11, 18 are directly connected to the control box 42, and the left- and right-hand light source boxes 41a, 41b become unnecessary. In the phase-contrast haploscope A according to the present embodiment described above, four holes of each kind, i.e. through holes 5a-5d and rectangular arc-shaped project-through holes 6a-6d and 7a-7d are arranged with an inter-hole phase angle of 90. The number of holes of each kind is not limited to 4. One hole may be provided, or multiple holes may be arranged at the same phase angle. In detail, in the rotary disc B for the phase-contrast haploscope according to the present invention, four holes of each kind, i.e. through holes 5a-5d and project-through holes 6a-6d and 7a-7d are arranged. A rotary disc having a single hole of each kind arranged with an inter-hole angle of 360 degrees, rotary disc B' having two holes of each kind arranged with an inter-hole angle of 180 degrees as shown in FIG. 8, and rotary disc B" having three holes of each kind arranged with an inter-hole angle of 120 degrees as shown in FIG. 9 may be acceptable. In these cases, when the motor 22 coupled directly with the motor shaft 22a rotates at a speed of 120 c/s or 7200 rpm, the changeover speed is calculated as follows: ______________________________________1 hole 7200 times/minute2 holes 7200 × 2 = 14400 times/minute3 holes 7200 × 3 = 21600 times/minute4 holes 7200 × 4 = 28800 times/minute______________________________________ Hence, to attain the same changeover speed, ______________________________________1 hole 7200 rpm2 holes 7200/2 rpm = 3600 rpm3 holes 7200/3 rpm = 2400 rpm4 holes 7200/4 rpm = 1800 rpm______________________________________ Thus, as the number of holes increases, the speed of the motor can be lowered. Accordingly, a torque load can be reduced, and a cheaper motor can be employed. Of course, in place of one large through hole 4 in the present embodiment, a pair of left- and right-hand through holes corresponding to the left- and right-hand look-through holes 2, 3 may be used. The present embodiment has the above-described concrete structure. Operations of the present embodiment will now be described. The apparatus according to the present embodiment is moved to a desired place. The apparatus is locked using the locks 31a' of a group of casters 31a. The plug 70 of the power cord 71 is inserted into a power connector (not shown). After loosening the adjusting stopper screw 32a, the rotary handle 32 is turned in the forward or reverse direction to project or retract the screw rod 30b according to the sitting height of examinee p who sits on a separately prepared chair, so that an appropriate height is attained. The adjusting stopper screw 32a is thereafter tightened. According to the face profile of the examinee p, after loosening the adjusting set screw 25, the forehead rest 23 is advanced or retracted along the guide cylinder 24 until an appropriate position is reached, and the adjusting set screw 25 is then tightened. Also, after loosening the adjusting set screw 40, the cylindrical slider 39 is vertically slid along the left- and right-side parallel guide uprights 36, 37 until the chin rest 38a together with the cross-plate 38 reaches an appropriate position, and the adjusting set screw 40 is then tightened, thus determining the height of the chin rest 38a. Thus, the face of the examinee p with respect to the front plate 1a is set so that both eyes of the examinee p are properly seen from the central portions of the left- and right-hand transparent plates 26, 27 of the left- and right-hand look-through holes 2, 3. After turning on the power switch 43 on the control panel 42b, the left- and right-hand brightness controls 44, 45 are adjusted, and the speed controller 46 is adjusted while checking a speed displayed on the digital speedometer 47. Next, the left- and right-hand slide boxes 50a, 51a are pulled out, and the left- and right-hand lantern slides n, o used for an examination are loaded thereinto. The slide boxes are inserted back into the left- and right-hand slide loaders 50, 51. The handles 64, 65 for swinging the left- and right-hand mirrors are operated horizontally and vertically so that for example, the targets h, g: on the left- and right-hand lantern slides are projected ion the plane of projection m at a desired position. At the same time, the left- and right-hand zooms 52, 53 are operated to zoom in or out the projected left- and right-hand targets h, g. After the adjusting operations: have been completed, when the rotary disc B is rotated, for example, at a speed higher than the critical fusion frequency (100-120 c/s or higher) as in the conventional phase-contrast haploscope, the left and right changeover speed becomes twice that of the conventional synchronous type phase-contrast haploscope. As the rotary disc B rotates at a high speed in the direction of an arrow as illustrated, the centers of the through holes 5a-5d revolve traveling along out the concentric circular path α. The through holes 5a-5d pass one by one in front of the left- and right-hand look through holes 2, 3 whose centers are located on the concentric circular path α. One of the through holes 5a-5d coincides instantaneously with the left-hand look-through hole 2, and then after the elapse of a predetermined instantaneous time, it coincides instantaneously with the right-hand look-through hole 3. Thus, as a result of the through holes 5a-5d in the rotary disc B revolving counterclockwise and passing in front of the left- and right-hand look-through holes 2, 3, the left- and right-hand look-through holes 2, 3 alternately coincide with one of the through holes. While the rotary disc B makes one rotation, the alternation occurs 4 times for instantaneous coincidence. In synchronism with the above, as the rotary disc B rotates, the rectangular arc-shaped inner project-through holes 6a-6d and the rectangular arc-shaped outer project-through holes 7a-7d rotate between the left-hand beam emitting end of the left-hand optical fiber 11 or the left-hand halogen lamp 72 and the beam incident end opposed thereto of the beam incident hole of the left-hand transmitting optical fiber 12 on the front plate 1a or between the right-hand beam emitting end of the right-hand optical fiber 18 or the right-hand halogen lamp 72 and the beam incident end opposed thereto of the beam incident hole 17a (not shown) of the right-hand transmitting optical fiber 19 on the front plate 1a, and travel along the inner concentric circular path γ and the outer concentric circular path β, respectively. Synchronously with the instantaneous coincidence of one of the through holes 5a-5d with the left-hand look-through hole 2, one of the rectangular arc-shaped inner project-through holes 6a-6d corresponding to the one of the through holes 5a-5d passes between the beam emitting end of the left-hand optical fiber 11 or the left-hand halogen lamp 72 and the beam incident end opposed thereto of the left-hand transmitting optical fiber 12. At that time, a left-hand projecting beam L emitted from the beam emitting end of the left-hand optical fiber 11 or the left-hand halogen lamp 72 passes through one of the rectangular arc-shaped inner project-through holes 6a-6d and enters the beam incident end opposed thereto of the left-hand transmitting optical fiber 12. The beam irradiates the lantern slide n inserted into the left-hand projector 48 via the left-hand transmitting optical fiber 12. The beam from the left-hand projector passes through the left-hand zoom 52. Then, a projecting beam q reflected on the left-hand mirror 58 projects the left-eye target h on the plane of projection m. Thus, the left eye can visually recognize the left-eye target h through the left-hand look-through hole 2 and one of the through holes 5a-5d coinciding instantaneously therewith and the through window 4. On the other hand, synchronously with the instantaneous coincidence of one of the through holes 5a-5d with the right-hand look-through hole 3, one of the rectangular arc-shaped outer project-through holes 7a-7d corresponding to the one of the through holes 5a-5d passes between the beam emitting end of the right-hand optical fiber 18 or the right-hand halogen lamp 73 and the beam incident end opposed thereto of the right-hand transmitting optical fiber 19. At that time, a right-hand projecting beam L emitted from the beam emitting end of the right-hand optical fiber 18 or the right-hand halogen lamp 73 passes through one of the rectangular arc-shaped outer project-through holes 7a-7d and enters the beam incident end opposed thereto of the right-hand transmitting optical fiber 19 of the right-hand beam incident hole. The beam irradiates the right-hand lantern slide o inserted into the projector 49 via the right-hand transmitting optical fiber 19. The beam from the projector 49 passes through the right-hand zoom 53. Then, a projecting beam r reflected on the right-hand mirror 59 projects the right-eye target g on the plane of projection m. Thus, the right eye can visually recognize the right-eye target g through the right-hand look-through hole 3 and one of the through holes 5a-5d coinciding instantaneously therewith and the through window 4. Thus, the left- and right-hand projecting beams L are intermittently blocked as the rotary disc B rotates. Also, synchronously with the coincidence between the left- or right-hand look-through hole 2, 3 and one of the through holes 5a-5d, the targets h and g of the left and right eyes can be alternately changed over at a high speed and separated completely from each other. An examiner such as a doctor adjusts the orientation of the left- and right-hand mirrors 58, 59 and examines in a third party's manner or objectively various binocular functions including the state of fusing the targets h, g in the vertical and horizontal directions. A second embodiment of the present invention will now be described with reference to drawings. FIG. 10 is a front view showing essential portions of a phase-contrast haploscope according to the present embodiment. FIG. 11 is a right-hand side view of the haploscope. The same members as the first embodiment are denoted by the same reference numbers to avoid redundant description. In the figures, A' denotes the phase-contrast haploscope according to the present embodiment. Designator 74 denotes a gantry stand which comprises left- and right-hand supports 74a, 74b standing upright on a base 33 to pass the intermediate portions of left- and right-hand optical fibers 11, 18 therethrough and a top plate 74c. Designators 75 and 76 denote left- and right-hand right-angled triangle shaped auxiliary cases which stand on the top plate 74c of the gantry stand 74 on both sides of a disc case 1 standing on the top plate 74c in such a manner as to support the sides of the disc case and which allow the intermediate portions of the left- and right-hand optical fibers 11, 18 and left- and right-hand transmitting optical fibers 12, 19 to pass therethrough for neat arrangement. Designator 77 denotes a chin rest fixed to a top-end head 80a of a screw rod 80 which passes through the end portion of a stepped crank bracket 78, whose base end is fixed on the bottom face of the top plate 74c of the gantry stand 74 below the middle between left- and right-hand look-through holes 2, 3, and which rises or lowers by turning a cylindrical adjusting nut 79 having knurls 79a and engaging therewith. Designators 81 and 82 denote left- and right-hand pivoting pins which pivot the left- and right-hand projectors 50, 51 in a vertically swinging manner between left-hand forked brackets 87 and between right-hand forked brackets 88, respectively. The left- and right-hand forked brackets 87, 88 stand on forked bracket base coupling portions 85, 86, respectively, in a horizontally rotatable manner, which coupling portions are located on the top ends of left- and right-hand support stands 83, 84 studded upright into a base 33. Designators 89 and 90 denote a pair of handles, as operating means, projecting downward at right angles to auxiliary plates 91, 92 at their rear ends, which auxiliary plates are attached to the bottom portions of slide loaders 50, 51 of left- and right-hand projectors 48, 49. Designators 93 and 94 denote equilibrating tension springs one end of which is attached to the end of the left- or right-hand auxiliary plate 91, 92 with a retaining pin 95 and the other end of which is attached to the forked bracket base coupling portion 85, 86 with a retaining pin 96, thereby horizontally biasing the left- and right-hand projectors 48, 49 and the left- and right-hand auxiliary plates 91, 92. Other portions are configured in the same manner as the first embodiment. The present embodiment has the above-described concrete structure. Operations of the present embodiment will now be described. While adjusting a forehead rest 23, the vertical position of the chin rest 77 is set according to the face profile of examinee put by turning the cylindrical adjusting nut 79 in the forward or reverse direction to raise or lower the screw rod 80. Thus, the face of the examinee p is set with respect to the front plate la so that both eyes of the examinee p are properly seen from the central portions of the left- and right-hand transparent plates 26, 27 of the left- and right-hand look-through holes 2, 3. The left- and right-hand handles 89, 90 are moved right and left or up and down to horizontally swing the left- and right-hand forked brackets 87. 88 and at the same time to vertically swing the left- and right-hand projectors 48, 49 so that for example, the left- and right-hand targets h, g on the left- and right-hand lantern slides n, o are projected on the plane of projection m at a desired position. At the same time, operate left- and right-hand zooms 52, 53 to zoom in or out the projected left- and right-hand targets h, g. Other members and mechanisms are adjusted in the same manner as the first embodiment, and hence various examinations of the examinee p are executed in the same manner. As described above, a rotary disc according to the present invention provides a higher rotational speed above the critical fusion frequency of a single rotary disc to change over the vision of both right and left eyes and thus to separate targets of both right and left eyes from each other. Hence, it becomes possible to set conditions quite similar to the ordinary vision for both right and left eyes. Thus, under these conditions, it is possible to examine various functions of binocular vision, i.e. subjective angle of squint, retinal correspondence, fusion faculty, subjective vision, suppression, aniseikonia, circumflex deviation and others in near natural state. Accordingly, it is possible to easily examine an examinee over a long period of time without causing uncomfortableness or pain and thus to obtain a higher diagnostic reliability. Also, a phase-contrast haploscope according to the present invention allows one to adjust it according to the sitting height and face profile of an examinee irrespective of age or sex, and hence can immediately cope with any examinee. A small-sized, light, compact structure allows the apparatus to be moved to any location for use anywhere a power source and a required occupational space are available. When not in use, the apparatus can be stored in a compact manner. Moreover, since only one motor is used to rotate a rotary disc, synchronous control is unnecessary, and hence a control technique is quite simple. As a result, the apparatus does not require much adjustment, is reliable, is very durable, and is easy to maintain. Also, no special skills are required for operation, and an initial cost is lower. The phase-contrast haploscope according to the present invention is equipped with zooms and allows mirrors or projectors themselves to swing horizontally and vertically by handle operations. Thus, left- and right-hand targets projected on the plane of projection can be individually zoomed in or out or moved vertically or horizontally. As a result, it is possible to freely examine various functions of binocular vision, i.e. subjective angle of squint, retinal correspondence, fusion faculty, subjective vision, suppression, aniseikonia, circumflex deviation and others. By changing over the vision of both right and left eyes at a higher rotational speed above the critical fusion frequency of a single rotary disc and accordingly separating targets of both right and left eyes from each other, it becomes possible to set conditions quite similar to the ordinary vision for both right and left eyes. As a result, examinations can be conducted in near natural state. Accordingly, it is possible to easily examine an examinee over a long period of time without causing uncomfortableness or pain and thus to obtain a higher diagnostic reliability. Moreover, since as compared with conventional apparatus, the apparatus according to the present invention is smaller in size and scale, is minimized in the number of parts, and uses only one motor, synchronous control is unnecessary, and hence a control technique is quite simple. As a result, the apparatus does not require much adjustment, is reliable, is very durable, and is easy to maintain. Also, no special skills are required for operation, an initial cost is lower, and the apparatus does not occupy much space.

1a

RELATED APPLICATIONS [0001] This application is a non-provisional utility patent application claiming priority to United States provisional patent application Ser. No. 60/519,852, filed Nov. 13, 2003, now pending. The entire specification of the provisional application referred to above are hereby incorporated by reference to provide continuity of disclosure. FIELD OF THE INVENTION [0002] The presently described technology relates to a nutraceutical composition for use in the oral cavity that contains xanthones. More particularly, the presently described technology relates to a rapidly dissolving film for oral ingestion comprising xanthones, for example, derived from fruit of the Garcinia mangostana L. plant. BACKGROUND OF THE INVENTION [0003] Rapidly dissolving thin films for oral ingestion are well-known in the art. These films are a recognized alternative to pills, tablets, liquids and other forms of consumable therapeutic or cosmetic substances. These thin films offer several advantages over prior art forms. They are compact and easily carried about, usually via a plastic case having a pliable hinge that allows repeated opening and closing. They are also capable of being ingested discretely, as opposed to ingestion of pills or tablets that generally require movement of the mouth or jaws. [0004] Further advantages of thin films for oral ingestion are explained in detail in U.S. Pat. No. 6,177,096, which is incorporated herein by reference, U.S. Pat. No. 6,419,903, which is incorporated herein by reference, and U.S. patent application Ser. No. 2003/0206942, which is also incorporated herein by reference. These references further disclose the general chemistry and technology associated with thin films and various methods of manufacturing them. [0005] It is also generally known in the art that rapidly dissolving films can be used for delivering therapeutic amounts of pharmaceutically active ingredients and cosmetically active ingredients. For example, as disclosed in U.S. Pat. No. 6,177,096, thin films can be used to deliver cosmetic agents such as breath freshening compounds, flavors for oral hygiene, fragrances for oral hygiene, active ingredients for oral cleansing and active ingredients for dental cleansing, as well as drugs such as hypnotics, sedatives, antiepileptics, antispasodics, diuretics, antitussive expectorants and antibiotics. [0006] The medicinal properties of the Garcinia mangostana L. plant have increasingly been the subject of recent pharmacological and clinical studies. These studies have shown that some of the natural compounds derived from the plant yield surprising medicinal benefits, especially the xanthone compounds. The history of the Garcinia mangostana L. plant and the pharmacological benefits of individual xanthone compounds is described in more particular detail in U.S. Pat. No. 6,730,333 (Garrity et al.), which is incorporated herein by reference. [0007] Despite the known use of rapidly dissolving films for oral ingestion and the documented medicinal benefits of natural xanthones, the combination of these two distinct fields has been heretofore unknown. Accordingly, there exists a need in the art for a rapidly dissolving film material comprising xanthones suitable for oral ingestion. Moreover, there is a need in the art for a simple method of delivering therapeutic amounts of xanthones. There is a further need in the art for a xanthone product that can be easily and unobtrusively consumed. There exists a further need in the art for a consumable xanthone product that comprises xanthones derived from the fruit of the Garcinia mangostana L. plant, otherwise known as the mangosteen plant. BRIEF SUMMARY OF THE INVENTION [0008] The present technology described herein uniquely provides a source of natural xanthones that can be easily transported and inconspicuously consumed. In particular, the presently described technology relates to a rapidly dissolving film for oral ingestion comprising xanthones. [0009] In one aspect, the presently described technology provides orally consumable film composition comprising at least one ingredient selected from the group consisting of saliva inducing agents, surfactants, stabilizing agents, emulsifiers, thickeners, plasticizers, antimicrobials, water, water soluble polymers, binders, polyethylene oxides, propylene glycols, sweeteners, flavor enhancers, colorants, polyalcohols, and combinations thereof; and at least one xanthone. [0010] Preferably, xanthones to be used in the presently described technology are derived from natural plant sources, especially from fruit of Garcinia mangostana L. plant. For example, the pericarp of the fruit of Garcinia mangostana L. plant can be used alone or in combination with the pulp of the fruit as an excellent source of xanthones. BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS [0011] Not Applicable DETAILED DESCRIPTION OF THE INVENTION [0012] It is understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to limit the scope of the presently described technology. It is also understood that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference, unless the context clearly dictates otherwise. [0013] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. While various methods, compositions, and materials of the presently described technology are described herein, any methods and materials similar or equivalent to those described herein can by used in the practice or testing of the presently described technology. All references cited herein are incorporated by reference in their entirety. [0014] The film, which is normally a thin film, of the presently described technology is instantly wettable and rapidly dissolving. Thus, the film adheres to the roof of one's mouth or tongue, quickly and totally dissolves. The film comprises xanthone compounds for delivery through oral consumption. [0015] In one embodiment of the invention, the xanthones are derived from natural plant sources. Preferably, the xanthones can be derived from fruit of the Garcinia mangostana L. plant. In one preferred embodiment of the presently described technology, the xanthones are derived from the pericarp of mangosteen fruit. In another preferred embodiment, the xanthones are derived from a mixture of mangosteen fruit pulp and pericarp, thus ensuring a natural, holistic source of xanthones. [0016] In addition to xanthone compounds, the film of the presently described technology can comprise one or more of the following ingredients: saliva inducing agents, surfactants, stabilizing agents, emulsifiers, thickeners, plasticizers, antimicrobials, water, water soluble polymers, binders, polyethylene oxides, propylene glycols, sweeteners, flavor enhancers, colorants and polyalcohols. [0017] Any number of saliva enhancing agents can be used in the presently described technology. These agents are well known in the art, which include common food-grade sweeteners such as glucose, dextrose, fructose, lactose, maltose, xylose, sucrose, corn sugar syrup, and other sweet mono- or di-saccharides. A combination of synthetic sweeteners plus a non-sugar, sugar-related compound such as sorbitol, hexitol, maltilol, xylitol, and mannitol, or starch hydrolysate such as Lycansin, or the like is also advantageous in the presently described technology. Aspartame may also be used. [0018] The surfactants that may be used in the presently described technology can vary, but generally compromise one or more anionic surfactants. For example, when a combination of surfactants is used, the first component may be a polyoxyethylene alkyl ether and the second component may be a polyoxyethylene sorbitan fatty acid ester. The ether compound may have an HLB value of 14-16, while the ester compound may have an HLB value of between 10 and 20. Of course, these values can vary, as one of ordinary skill in the art will appreciate. [0019] Stabilizers useful in the presently described technology include xanthan gums, carrageenan, and the like. In one embodiment of the presently described technology, antimicrobials are included in the formulation. These compounds include essential oils such as eucalyptol, menthol, vacrol, thymol, methyl salicylate, verbenone, eugenol, gerianol and combinations thereof. [0020] The water soluble polymers of the presently described technology can exhibit film forming properties, so the xanthone-containing mixture can be spread into a thin film with sufficient tensile strength to withstand cutting, dicing and packaging of the product. Typical polymers include, but are note limited to, amylase, arabic gum, carboxymethyl cellulose, carboxyvinyl polymers, collagen, dextrin, gluten, guar gum, acacia gum, high amylase starch, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylated high amylase starch, hydroxypropylmethyl cellulose, methylmethacrylate copolymers, polyacrylic acid, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, pullulan, sodium alginate, tragacanth gum, whey protein isolate, and combinations thereof. [0021] Polyalcohols give a soft feel to the film and allow the film to conform to the contours of the oral cavity. Useful polyalcohols for purposes of the presently described technology include glycerol, polyethylene glycol, propylene glycol, glycerol monoesters with fatty acids or other known polyalcohols. If colorants are used in the presently described technology, they should be non-toxic and approved by the Food and Drug Administration. [0022] Although there are a number of different methods of producing the thin films of the presently described technology, one method is as follows: The non-water soluble plasticizers, surfactants, and polyalcohols are dissolved in an appropriate amount of solvent, which may include water-alcohol mixtures. The other water soluble ingredients and xanthones are then slowly added until a single homogeneous solution is obtained. It may be necessary to heat the solution to accommodate thorough mixture and dissolving of all ingredients. The resulting soup mixture is then poured or coated onto a non-stick drying surface that allows even spreading of the mixture across its surface. The mixture is slowly cooled and/or dried until it hardens and the thin film is formed. The thin films are then cut into shapes suitable for packing. [0023] The invention will now be explained with reference to the following example, which are given for illustration only and are not intended to be limiting thereof. EXAMPLE 1 [0024] A rapidly dissolving thin film was made by combining the ingredients listed below: Ingredients Amount Natural compounded liquid mangosteen flavor 4.5%-4.9% Mangosteen fruit extract 0.1%-0.5% Vitamin C  0.2% Aspartame 0.04% Xanthan gums 2%-3% Water Remainder [0025] In this example, whole fruit of the mangosteen fruit is ground into a mixture containing pericarp and fruit pulp. Xanthones are then extracted from the mangosteen whole fruit mixture by dissolving the whole fruit mixture in an alcohol based solvent. The solvent containing extracted xanthones is then mixed with other ingredients in the amount of from about 0.1% to about 0.5% to make a mixture solution. The mixture solution is rolled out on a sheet, and water is evaporated off using an airflow cooling tunnel over a period of about 24 hours. The resulted thin film is then cut into desired shapes and sizes. [0026] The presently described technology may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the presently described technology is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

1a

FIELD OF THE INVENTION [0001] Structures are disclosed for creating a sub-floor or other horizontal surface of hooks, the surface being formed from adjacent anchor sheets connected by attachment pieces. BACKGROUND OF THE INVENTION [0002] Several earlier patents by one of the same inventors disclose an anchor sheet which can be supplied as a small or large module, with or without a pre-attached decorative covering. U.S. Pat. Nos. 6,306,477; 6,298,624 describe anchor sheets. Such anchor sheet is also described in a more detailed way in international patent application number PCT/CA00/00681, that was published under WO 00/74544 on Dec. 14, 2000, and U.S. application Ser. No. 09/008,584 filed Jan. 16, 1998, the specifications of all of which are incorporated by reference. These earlier applications also disclose the anchor sheet as a modular unit, many of which many can form a contiguous mass of anchor sheets to be used as a sub-floor. A decorative covering may be attached to the sub-floor, or the sub-floor may be used as a finished floor when presupplied with a decorative surface. Such a contiguous mass can be formed by attaching the anchor sheets together by some form of overlap or by abutting the anchor sheets to each other and using an overlap of decorative covering or tape. Such mass can be free floating or attached to the floor. SUMMARY OF THE INVENTION [0003] The current invention relates to improved anchor sheets and attachment pieces which when abutted or overlapped can form a generally-flat planar sub-floor or other surface for detachable attachment of overlying decorative pieces, preferably with a hook and loop system. The attachment pieces (also called attachment devices or corner pieces, because they frequently fit into the corner of another sheet), are really generally smaller anchor sheets provided with one-half of a male or female connection, the other half of the male or female connection being placed upon the “main” anchor sheet. It should be appreciated, however, that the size of the anchor sheet and anchor or attachments pieces is somewhat arbitrary. It is possible to have quite small anchor sheets and very large attachment pieces so that, in effect, there is no distinction between the “attachment pieces” and the anchor sheets. Effectively there are two sets of sheets which are overlapped to form a planar surface. In practice, one of the sheets will have a countersunk area of a thickness matching the thickness of at least a portion of the other sheet, so that when overlapped, a planer, substantially flat surface will be presented. Also, generally in practice, one of the sheets will be of a size to substantially cover the floor, with the other sheet being substantially smaller (generally called the “attachment piece”), for fitting into the countersunk area of the anchor sheet. Both the anchor sheets and the attachment pieces themselves are preferably made of polypropylene, or some other plastic. Such plastic may expand and contract according to temperature and humidity. The anchor sheets (and attachment pieces), are preferably designed to have hooks on their upper surface, which receive a covering of decorative pieces, which have loops complimentary to the hooks. If the decorative pieces are, for example, carpet pieces, then it is also advantageous to additionally allow for expansion and contraction of the carpet pieces, by allowing for relative movement of the anchor sheets. However, the anchor sheets themselves also can expand and contract according to temperature and humidity, and therefore, it is advantageous to allow for some expansion and contraction in any event. [0004] It is also advantageous to have the sheets connected together in a positive way, but so as to prevent anchor pieces and anchor sheets from rising up or riding up in relation to each other, which could create a non-planar surface. Thus, it is helpful for the attachment to have a positive connection in a direction at right angles to the plane of the surface, for example a floor, while allowing for some relative movement in a direction along or with the plane of the floor. It is also advantageous if a connection can provide for positive registration, so that the sheets are oriented and spaced in relation to each other by the attachment piece. [0005] Thus, in one aspect of the invention, there is provided a structure for attachment between attachment pieces and anchor sheets, which allows for relative movement between the attachment piece and each anchor sheet, and therefore relative movement between anchor sheets forming a planar surface. This structure can also create a suitable space in between anchor sheets during installation, by setting a connection point between the anchor sheets and the attachment pieces. In another aspect of the invention, one of either the anchor sheet or attachment piece has a male connection and the other a female connection. One of the sheets has a countersunk area containing the one-half of a male and female connection, and the other sheet or attachment piece has the other half of the male-female connection. In addition, either the female element is provided with means for motion of the aperture into an expansion space, or the male element is provided with means so that it can move into an expansion space in a direction along the plane of the floor. [0006] Thus, in one aspect, the invention comprises a male and female connection for overlapped sheets, comprising the following: (i) a first anchor sheet having a substantially horizontal surface, and having a portion countersunk from the horizontal surface at, at least, one edge; and (ii) a central aperture within the countersunk portion; and (iii) a second anchor sheet having at least an overlap portion of a thickness to fit into the countersunk portion of the first anchor sheet, to present a substantially planar surface, the second sheet having a male member having a shaft sized to fit into the aperture on the first sheet member, and having a second portion larger than the aperture at the end of the shaft to create a cam surface means to prevent removal of the male member from the aperture, in which at least one of the male or female members have expansion openings or areas of flexibility in the first or second sheets surrounding either the male member or female aperture, to provide for movement of either the male or female part, in a path between the expansion areas. [0007] In a second aspect, the invention comprises a first sheet member to connect to an overlapped second sheet member to form a substantially horizontal surface, comprising the following: (i) the first sheet member having a first surface and a countersunk surface below the level of the first surface; (ii) the first sheet member having in the countersunk portion a first aperture; (iii) the sheet, provided on two opposite sides of the first aperture with expansion openings proximate to the first aperture, so as to create areas in the sheet of increased flexibility, from either side of the first aperture and a path substantially in the line drawn between the middle of the second and third apertures. [0008] In another aspect, the invention comprises a male sheet member to connect to an overlapped female sheet member to form a substantially horizontal surface, comprising: (i) a sheet member of a thickness substantially the same as the depth of a countersunk portion on a corresponding female sheet member and having a first upper surface; (ii) a snap-fit means comprising at least two flexible prongs projecting from the opposite bottom surface, and having a normal memory position, of a size slightly larger than the size of an aperture of a corresponding female sheet member, each prong having a cam surface projecting radially outwardly. [0009] In an additional aspect of the invention, the invention comprises: (i) a first sheet member having a first surface and a countersunk surface below the level of the first surface, the first sheet having, in the countersunk portion, a first aperture of a diameter x, and a channel of a smaller diameter, and a second sheet member with at least an overlapping portion of a thickness matching the thickness of the countersink of the first sheet member and, having a male member with a stem and a head. The head fits into the aperture of the first sheet member in a first location and the stem has a thickness corresponding to the channel of the first sheet member, so that the second sheet member can be inserted into the first sheet member through the aperture and the shaft moved into the channel to prevent upward motion of the head and of the first sheet member in relation to the second sheet member, and in which the male sheet member contains areas of expansion and flexibility on opposite sides of the male member, so as to provide for flexible movement of the male sheet member in relation to the second sheet along a path drawn between the areas of flexibility surrounding the male member. The areas of expansion may be apertures surrounding the male or female members. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a portion of an anchor sheet showing a countersink. [0011] FIG. 2 shows four anchor sheets overlapped on a floor. [0012] FIG. 3 shows an anchor sheet and attachment device. [0013] FIG. 4 is a perspective view of an attachment piece from below. [0014] FIG. 5 is a perspective view of an anchor sheet to receive the attachment piece of FIG. 4 . [0015] FIG. 6 is a plan view of an attachment piece and surrounding anchor sheets with complementary first and second halves of a flexible detachable attachment. [0016] FIG. 7 is an alternative embodiment for a first and second anchor sheet showing a male member with areas of flexibility. [0017] FIG. 8 is a detail of the male member of FIG. 7 . [0018] FIG. 9 is a detail of the male and female member of FIG. 7 united on a sheet, in plan view from above. DETAILED DESCRIPTION [0019] Preferably in the preferred embodiment, as shown in FIG. 1 , an anchor sheet 1 has a polyethylene layer 9 , in which there is a countersunk area 7 at (in this case), a corner. The sheet is made of polyethylene and is substantially covered with hooks 4 that are injection molded into the sheet. Details of this are described in the corresponding applications entitled “System and Methods of Manufacturing Hook Plates” and “Improved Anchor Sheet” by some of the same inventors filed concurrently herewith, and in earlier cases described earlier in this application, all of which are incorporated herein by reference. The anchor sheet typically has a resilient layer 5 , but this is not necessary for the operation of this invention. Contained within the countersunk area, in at least one embodiment, is an aperture 15 and surrounding expansion areas 16 and 17 , which will be described more fully in detail later. [0020] Shown in FIG. 2 , is a series of anchor sheets, which in this embodiment have an overlapping area 23 and 25 , but such overlapping area is also not necessary for this invention. In FIG. 2 , the countersunk area for the attachment device is shown at 21 . [0021] FIG. 3 , shows an anchor sheet also having a countersunk area 7 , an aperture 15 and expansion areas in the sheet 16 and 17 . These are areas of reduced strength, so as to allow for movement of the rim 14 around the aperture 15 into the expansion areas as will be described later. FIG. 3 also shows an attachment device 31 , which typically will contain a male protrusion 33 , projecting onto its under-surface, and which will conform to and fit into aperture 15 , as also will be described in further detail later. [0022] FIG. 4 , shows in more detail, a male prong 33 as seen from below attachment device 31 . Registration members 35 are also placed underneath attachment piece 31 . Male prong 33 is a flexible protrusion, which has a normal memory position as shown in FIG. 4 , which is slightly larger than aperture 39 . It has a cam surface 37 , which contains an edge slightly larger than the corresponding aperture 39 contained in the sheet 1 . Shown in FIG. 5 , is sheet 1 having aperture 39 . There is also a corresponding indentation 41 , which matches with the registration member 35 to help centre the snap-fit connection. In practice, male prongs 33 have sufficient flexibility that they can move slightly into aperture 39 , but are normally in a position whereby cam surface 37 fits onto the edge 43 of aperture 39 to prevent disengagement of the attachment device 31 from the anchor sheet 1 . As will be explained later, there are apertures or expansion openings 45 through the polyethylene sheet 1 , and surrounding the aperture 39 on opposite sides, so as to create effectively a structure whereby the aperture 39 is surrounded by a thin surrounding layer of plastic 47 as a rim on two sides of the aperture, thus to allow the aperture to move in a path between the two expansion openings 45 . The movement of the aperture allows for some movement of the whole connection between the attachment device 31 and anchor sheet 1 as will be described later. Some movement is also available because of movement of the prongs 33 . By appropriate placement of the aperture 39 and prongs 33 in of the overlap area of an attachment piece 31 and the overlap of an anchor sheet 1 , an appropriate space can be created between the attachment piece and the anchor sheet. During atmospheric expansion and contraction, the flexibility of prong 33 and the flexibility of rim 47 and 48 around surrounding opening 39 , allow rim 47 and 48 to move into the expansion openings 45 as necessary to accommodate expansion and contraction. [0023] The prong 33 and rim 47 and 48 may be made from the same material as the anchor sheet or the attachment piece, as long as the material is sufficiently flexible. It is preferred that the material be polypropylene or polyethylene. For example, polypropylene such as that sold as STAMYLAN™ P112MN40 with an ISO of 1873 indication of PP-H,MA-M400 is acceptable. This material has a melt-flow index of 50 (T-230 degrees C., F=2.16 kg) a tensile modulus of 1900 MPa, proportional strength of 35 MPa, ultimate strain of greater than 50%, a density of 910 kg/m 2 , and a melting point of approximately 160 degrees Celsius. The attachment device 31 may include two registering pins 35 and two corresponding indentations 41 for receiving pins 35 . Pins 35 and indentations 41 co-operate to align the attachment piece 31 with the anchor sheet 1 . This arrangement can encourage atmospheric expansion and contraction to occur, in a direction along a line 572 or 574 that passes approximately through the middle of expansion openings, as shown in FIG. 6 . In FIG. 6 , attachment piece 430 has male members 432 , 434 , 436 , and 438 on the bottom surface of its upper-disk, with corresponding registering pins 440 , 442 , 444 , and 446 . These fit into corresponding openings 448 , 450 , 452 , and 454 and corresponding pin receptacles 456 , 458 , 460 and 462 . After the prongs and registering pins are inserted into the corresponding round opening and pin receptacles, atmospheric expansion and contraction will be encouraged to take place generally through the centres of the horseshoe openings 464 , 466 , 468 and 470 , along lines 574 and 572 . It is not necessary to restrict the expansion and contraction to these lines, but it is thought in practice that this is the natural way that the sheets will expand and contract. [0024] Referring to FIG. 3 , while in the above description, the first half of the attachment device has been described as being an attachment piece 31 , and the second half has been described as being on an anchor sheet 1 , there could be a reversal of the male and female members, however because the male member projects down into the resilient layer 5 , it is preferable to have the male member on the attachment piece which is projecting into the resilient layer. [0025] As shown in FIG. 7 , male member 61 can also be provided with expansion openings 63 and 65 , which will allow for the male member to move on the attachment device 31 . In this embodiment, male member 61 is inserted into keyhole 67 , and then twisted to move into channel 69 . The flange or cam surface 71 on male member 61 , prevents the upward movement of attachment piece 31 once it has been moved into channel 69 . In addition, there are also registration pins 73 on the underside of head 61 , which can register with small indentations 75 to locate the attachment device 33 in relation to the anchor sheet 1 . As shown in FIG. 8 , registration pins can also be registration receptacles 77 , so co-operate with pins at locations 75 on anchor sheet 1 . FIG. 8 also shows the expansion opening 63 in greater detail. FIG. 9 shows the attachment device 31 and the anchor sheet 1 shown in plan view from above. Because of the countersink, attachment device 31 and anchor sheet 1 are on the same plane, presenting a flat surface. Not completely shown, but to be understood, is that typically the anchor sheet will be covered in hooks (not shown), as will the attachment device 31 . [0026] It is noted that those skilled in the art will appreciate the modifications of detail may be made from the embodiments described herein which would come within the spirit and the scope of the invention as described in the following claims.

1a

1. FIELD OF THE INVENTION [0001] This method relates diet management; and, more particularly, to a fasting method that utilizes juices and vegetable soup to stave off hunger pangs by providing a high sugar and carbohydrate content that satisfies the brain glucose-glycogen need. 2 . DESCRIPTION OF THE PRIOR ART [0002] There is a global epidemic of obesity taking place, which leads to several obesity related diseases. There is a strong desire to effectively lose excess body weight. The present invention relates to a fasting method designed to lose excess body weight and body fat, and improve the functionality of critical body organs without creating hunger pangs as the duration of fasting effort progresses. [0003] Many patents and prior art documents relate to fasting methods. These methods aim towards reducing the body weight of the fasting person by merely reducing the calorie intake by way of limiting the quantity of food consumed. These methods do not pay attention to body mechanisms that control brain function, the needs of muscle tissues, or the perception of hunger. Restriction of calorie intake generally results in the slowing down of the body metabolism and body quickly adapts to this calorie intake reduction and eliminating non-essential body functions in order to maintain core body functions. When a person exits from the fasting routine, body weight is quickly regained back to its original weight value or that is in excess of the original weight value. Prolonged deliberate fasting generally results in the fasting person feeling extremely tired and unable to move readily. In many cases, the muscle mass in the fasting person's body is consumed to generate the required glucose or glycogen substitute for the brain function, and causes the loss of protein rich muscle tissue which is consumed to produce a glucose substitute that results in the loss of muscle mass, further weakening the fasting person's body. [0004] Generally people discontinue juice fasting routine pretty early in the process due to hunger pangs. They are deprived of energy, which is required for daily activities, or to support tasks that require muscular movement, or to have mental focus required for concentration, and this leads to a rapid failure of the juice fasting attempt. The method detailed herein addresses these issues and provides a unique solution. [0005] U.S. Pat. No. 6,069,131 to Marsh discloses pre-operative beverage composition and method of treatment. This specially formulated beverage composition is designed to be ingested by a pre-operative patient at least about 2 hours prior to administration of anesthesia. The beverage composition is a single-serving volume containing at least about 200 calories, which calories are primarily from a non-protein, non-fat source, such as one or more carbohydrates. The composition includes about 48 grams maltodextrin, about 6 grams fructose and about 6 grams glucose, in water with enough citric acid to provide a final solution pH of about 4.3. This beverage composition, when ingested during pre-operative fasting, at least about 2 hours prior to administration of anesthesia, encourages compliance with pre-operative fasting requirements; reduces the incidence of symptoms associated with prolonged fasting, such as feelings of hunger and thirst, lightheadedness, irritability and headache; and should reduce the risk of aspiration pneumonia by providing a residual gastric volume and gastric pH within generally accepted ranges. Also, contemplated herein is the method of using this beverage composition to increase compliance with pre-operative fasting guidelines and thereby decrease the risk of aspiration pneumonia in the anesthetized/sedated patient. This fasting beverage is designed only for a short time fast of typically two hours before administrating an anesthesia and is not designed for a long time fast typically required for hunger free fasting that reduces body fat and improves body mass index. [0006] U.S. Pat. No. 8,715,742 to Koide discloses method for reducing weight in a subject. This method is provided for reducing weight in a subject by administering an effective amount of a composition comprising omega-3 polyunsaturated fatty acid (PUFA), at least one of L-arginine, L-ornithine, an L-arginine precursor and an L-ornithine precursor, and at least one of nucleobase, a nucleoside and a nucleic acid. The method can also be used to treat obesity, hyperlipidernia, diabetes and/or hypertension and for improving diathesis, or treating adult disease or disposition to adult disease. This method does not provide adequate glucose or glycogen required for brain functioning and satiation. [0007] U.S. Pat. No. 7,629,329 to Lee et al. discloses a method for increasing muscle mass and strength through administration of adenosine triphosphate. This method uses compositions that have an effective amount of Adenosine Triphosphate (“ATP”) sufficient to increase intracellular and extracellular concentrations of ATP in a mammal to improve anaerobic exercise capacity by increasing muscle size and/or strength. Preferably, a gastric acid secretion. inhibitory coating is applied to the effective amount of ATP in a manner that protects the ATP from degradation by gastric juices. ATP compositions may be administered in nutraceutical or functional food dosage forms, including oral and non-oral delivery forms. In addition, the effective amount of ATP maybe combined with amino acids, botanicals, functional foods, herbals, nucleotides, nutraceuticals, nutrients, pharmaceuticals, proteins, and/or vitamins in an effort to enhance the targeted activity of the composition. In spite of the coating that protects the ATP from being destroyed by the gastric juices, the ATP levels are not increased for at least about 60 minutes from the time at which the ATP containing composition is consumed as indicated in the figures. The composition does not provide sustained or increased muscle activity after the consumption of the ATP containing composition, rather kicks in only after an hour later. [0008] U.S. Pat. No. 7,825,084 to Harris, et al. discloses methods and compositions for increasing the anaerobic working capacity in tissues. The composition comprises a beta-alanylhistidine dipeptide and a glycine, an insulin, an insulin mimic, or an insulin-action modifier and administering the composition to the tissue increases beta-alanylhistidine dipeptide synthesis in the tissue, thereby increasing the anaerobic working capacity in the tissue. The cause an increase in the blood plasma concentrations of beta-alanine and/or creatine. The composition contains artificial chemicals and does not contain natural ingredients or compounds indicated in the present invention disclosure. [0009] U.S. Pat. No. 7,897,169 to Ueda, et al. discloses ubiquinol-enriched fat-containing foods. The process for producing a ubiquinol-enriched oil/fat-containing food product for human ingestion comprises dissolving ubiquinol in oil/fat under heating first followed by cooling to obtain homogeneous solution with a melting point of not lower than 20° C. the cooling action solidifying the homogenous composition. The solidified composition is kneaded to form oil-in-water emulsion. The composition formed is not a gel or paste like substance and is not contained in a ready to use individually packed pouches. The composition is oil based, not water based and does not have other nutrients than ubiquinol. [0010] US Patent application 20110123653 to McKever et al. discloses compositions and methods for optimizing exercise recovery. The method decreases post-exercise recovery time in a subject using compositions that contain one or more polymethoxylated flavones (PMFs). The composition is an orange peel extract. The post-exercise recovery time is the time for a subject's post-exercise oxygen consumption VO 2 level to return to a pre-exercise VO 2 level. PMF composition is selected from PMFs, which are selected from the group consisting of 5,6,7,3′,4′-pentamethoxyflavone(sinensetin); 5,6,7,8,3′,4′-hexamethoxyflavone(nobeletin); 5,6,7,8,4′-pentamethoxyflavone(tangeretin); 5-hydroxy-6,7,8,3′,4′-pentamethoxyllavone (auranetin); 5-hydroxy-7,8,3′,4′-methoxyfiavone; 5,7-dihydroxy-6,8,3′,4′-tetramethoxyflavone; 5,7,8,3′,4′-pentamethoxyflavone; 5,7,8,4′-tetramethoxyflavone; 3,5,6,7,8,3′,4′-heptamethoxyflavone; 5-hydroxy-3,6,7,8,3′,4′-hexamethoxyflavone; 5-hydroxy-6,7,8,4′-tetramethoxyflavone; 5,6,7,4′-tetramethoxyflavone; 7-hydroxy-3,5,6,8,3′,4′-hexamethoxyflavone; and 7-hydroxy-3,5,6,3′,4′-pentamethoxyflavone. This composition merely reduces recovery time and does not increase muscle energy output during exercise. It is not a fasting routine and does not control hunger pangs. [0011] The publication “Brain Glucose Sensing, Counterregulation, and Energy Homeostasis” by Nell Marty, et al. published at PHYSIOLOGY 22: 241-251, 2007 available at web page at http://physiologyonline.physiology.org/content/22/4/241. This publication discloses methods by which the human brain monitors closely the blood glucose as a signal to control feeding behavior and energy expenditure. The glucose sensing neurons are highly represented in hypothalamic nuclei and the brain stern, regions involved in the control of energy homeostasis and food intake. Brain has very little or no storage of glucose or glycogen and does not have reserve ATP and requires continuous feed of blood glucose for brain operation. Stomach and intestine sense presence of food through Gluco-incretin secretion K-Cells (GIP) L-Cells (GLP-1) of the enteric nervous system. [0012] The Lipolysis and the Oxidation of Fatty Acids by Michael W King is available at http://themedicalbiochemistrypage.org/fatty-acid-oxidation.html and describes a mechanism by which fatty acid is removed from storage and oxidized for liberation of energy at muscles, as well as body cells. [0013] The web page at http://en.wikipedia.org/wiki/Fatty_acid_metabolism discloses that when blood sugar is low, decreasing insulin levels signal the adipocytes to activate hormone-sensitive lipase, and to convert triglycerides into free fatty acids. These free fatty acids have very low solubility in the blood, typically about 1 μM. However, the most abundant protein in blood, serum albumin, binds free fatty acids, increasing their effective solubility to ˜1 mM. Thus, serum albumin transports fatty acids to organs such as muscle and liver for oxidation when blood sugar is low. [0014] The web page at http://en.wikipedia.org/wiki/Beta_oxidation states that free fatty acids cannot penetrate the plasma membrane due to their negative charge. Once in the cytosol, activation of the fatty acid is catalyzed by long fatty acyl CoA synthetase. A fatty acid reacts with ATP to give a fatty acyl adenylate, plus inorganic pyrophosphate, which then reacts with free coenzyme A to give a fatty acyl-CoA ester plus AMP. If the fatty acyl-CoA has a long chain (10 or more carbons) then it is reacted with camitine to form acylcarnitine, which is transported across the inner mitochondrial membrane by a Carnitine-acylcamitine translocase. If the fatty acyl-CoA contains a short chain (less than 10 carbons) it can simply diffuse through the inner mitochondrial membrane. [0015] A number of advertisements relate to fasting, reduction in body weight as well as improvement of high blood pressure, diabetes and other illnesses. These programs do not disclose their methodology or scientific basis for the methods used and expected results as a function of time. [0016] There remains a need in the art for a safe and effective fasting system wherein the person undergoing the fasting procedure does not suffer excessive hunger or toss of muscle tissue without using synthetic medications and can effectively decrease body fat while maintaining full body energy. SUMMARY OF THE INVENTION [0017] The hunger minimized fasting system of the present invention utilizes a number of natural body processes to allow hunger free fasting without the feeling of hunger pangs for fasting periods lasting from 10 to 90 days. Prior art methods do not allow such prolonged fasts without the feeling of hunger. More importantly, with such prior art methods, the progressive fast decreases body energy available and a person becomes very week and is generally unable to move. By way of contrast, the system of subject invention maintains blood sugar level in the range of 5 to 10 mM (90- 180 mg/df,) which satisfies the brain's requirement for a continuous supply of glucose, since the brain does not store much glycogen or ATP, The brain also has sensors in the gut, which sense the presence of solids in the digestive organs and invoke digestive juices, again creating hunger pains. The absence of solids in the juices or soups used during fasting, which include fruit juices of various fruits and vegetable soup that is filtered of all solids, suppresses the brain generated hunger sensation and maintains satiety during prolonged fasting. Entering the fasting phase requires a pre-fast phase of 3 to 5 days wherein only fruits are consumed in the morning followed by raw vegetables in the evening, again restricting overall calorie intake. The body quickly learns to extract nutrients from this diet and is now ready for entering the fasting stage. [0018] The fasting stage comprises the inclusion of liquefied vitamins and minerals essential for producing all the enzymes and hormones needed to assimilate blood glucose created from the consumption of sugar or carbohydrate rich juices and soups. Since the calorie intake is deficient by about 600 to 1400 calories as compared to the required daily calorie requirement, fat reserves are used to generate sufficient calories for the daily functioning of the body with the help of hormone sensitive lipase. [0019] The fasting step involves consumption of 8 to 12 ounces of various clear fruit juices and solid free prepared vegetable soups every 2 to 4 hours representing a caloric intake of 800 to 1200 calories only, which is deficient by about 600 to 1400 calories on a daily basis. The consumption of the juices results in a steady blood glucose level of 5 to 10 mM (90-180 mg/dL) satisfying the brain's glucose need; the absence of solid material in the digestive track does not invoke the brain hunger response; and the fasting person remains satisfied throughout the fasting period. The brain does not demand release of glycogen stored in the muscles and liver, a step that generally results in the weakening of the fasting person. If blood glucose is not available, the brain will demand the liver to attack muscle tissue that is in contact with blood to convert the muscle to glucose simulant releasing nitrogen rich waste. Eating protein or meat does not solve this problem since the eaten food is not in contact with blood. The technology of the subject invention avoids all these problems brain demanding extraction of glycogen from muscles and liver or the degradation of muscle tissue. The system of the present invention maintains a consistent blood glucose level. [0020] The blood glucose from the consumption of juices and soups is converted to pyruvic acid and two ATP molecules in the extramitochondrial portion of the cell by the glycolysis process as detailed below. This process is anaerobic and does not care if oxygen is present or not. The pyruvic acid reacts with coenzyme A in the presence of pyruvic acid dehydrogenase enzyme using a molecule of ATP creating Acetyl Co A that enters the inner barrier of the mitochondria undergoing TCA cycle, which produces many molecules of ATP. TCA cycle occurs aerobically within the mitochondria, which has all the enzymes needed for TCA cycle except succinate dehydrogenase. [0021] Due to the combination of a reduced caloric intake and the brain having sufficient blood glucose levels, the only way the body can get adequate calories is by reaching out to consume stored fat tissues. Hormone sensitive lipase extracts fat from storage with the help of adrenaline hormone and is bound to blood serum albumin proteins and transported to cells and arrives at the extramitochondrial portion of the cell. Due to their negative charge these fats cannot enter the inner mitochondrial barrier. Once in the cytosol of the cell, activation of the fatty acid is catalyzed by long fatty acyl CoA synthetase. A fatty acid reacts with ATP to give a fatty acyl adenylate, plus inorganic pyrophosphate, which then reacts with free coenzyme A to give a fatty acyl-CoA ester plus adenosine monophosphate (AMP), precursor to ATP. If the fatty acyl-CoA has a long chain (10 or more carbons) then it is reacted with carnitine to form acylcarnitine, which is transported across the inner mitochondrial membrane by a Carnitine-acylcarnitine translocase. The acyl-CoA and adenosine monophosphate (AMP), precursor to ATP undergo TCA cycle producing large number of ATP molecules. [0022] Thus the technology of the subject invention uses body's metabolic processes to force the extraction of stored fat and conversion to ATP energizing body cells. The key feature is the presence and accumulation of ATP formed by the glycolysis process in the extramitochondrial portion of the cell. From blood glucose, the glycolysis process produces ATP and pyruvic acid, which is converted to Acetyl Co A that enters the inner mitochondria barrier as stated above. The fat molecules from fat storage are released into the blood stream by hormone sensitive lipase with the help of adrenaline hormone and transported bound to serum albumin arriving at the extramitochondrial portion of the cell, the very place where glycolysis produces ATP and is readily available. Once in the cytosol, activation of the fatty acid is catalyzed by long fatty acyl CoA synthetase. The fatty acid reacts with ATP to give a fatty acyl adenylate, plus inorganic pyrophosphate, which then reacts with free coenzyme A to produce a fatty acyl-CoA ester plus adenosine monophosphate (AMP), precursor to ATP. If the fatty acyl-CoA has a long chain (10 or more carbons) then it is reacted with carnitine to form acylcarnitine, which is transported across the inner mitochondrial membrane by a Carnitine-acylcarnitine translocase. During beta oxidation within mitochondria, acyl-CoA ester is produced and undergoes TCA cycle creating many molecules of ATP. If ATP is absent, the fat in the form of triglycerides and monoglycerides cannot enter the mitochondrial inner barrier and are returned back to storage. Thus the presence of ATP produced by glycolysis of sugar and carbohydrate rich juices and soups is essential for the metabolism of fats in the mitochondria. This is the mechanism by which both sugar and fat are converted to ATP in the TCA cycle producing large number of ATP molecules. This is the central feature of the invention. [0023] The initial preparation before entering fasting is carefully planned to reduce the amount of solid material entering the digestive elements of the body gradually. Consuming fruits do this in the morning followed by consuming raw uncooked vegetables at night for a period of 3 to 5 days. During this initial period 8 to 12 ounce sugar rich juices can be consumed every 4 hours to sustain hunger response. At the end of the 3 to 5 days of initial preparation, fasting may begin. [0024] The fasting procedure involves use of clear juices, including: orange juice, apple juice, pineapple juice, grape juice, pomegranate juice, coconut water, watermelon juice, cantaloupe juice, carrot juice, beetroot juice, celery juice, or combinations thereof, which are filtered using a very fine mesh cloth or sieve which filter out all solid residues present in the juice. In addition to the juices prescribed herein, a nutrient rich soup or extract of vegetables may be used to increase the intake of vitamins and minerals present in natural vegetables. The soup is prepared by slicing small pieces of carrots, broccoli, beets, celery, potatoes, sweet potatoes and other vegetables that is cooked in water without any additional salt and simmered for a period of 30 minutes in low heat of about 80° C. to 95° C. This reduced temperature cooking preserves vitamins and minerals. The soup is cooled to room temperature and all the solid materials is filtered out and discarded. The soup thus created is stored in in a refrigerated container for use during fasting. Preferably every fasting day is started and finished by the consumption of the nutrient rich vegetable soup, which reduces the onset of hunger pangs. The soup is supplemented with liquefied vitamin and brings in essential vitamins and minerals into the body of the person practicing fasting. Throughout the day filtered juices of various types are consumed typically in 2 to 4 hour intervals. Even within the very first day of fasting, surprisingly, the hunger response subsides rapidly and hunger pangs are minimized or eliminated. Prior to going to bed, the liquefied vitamin and mineral supplement is mixed with soup and is consumed. The procedure is repeated for as many days as a person practicing fasting desires to move forward. Typically people practice as detailed below fasting for 10 to 90 days easily to realign their body and reduce body weight to improve body mass index (BMI). On each day, a fasting person loses typically between about one half to one pound each day without feeling hunger pangs. This number of fasting days can be extended to 120 days. [0025] Briefly stated, the invention includes using sugar and carbohydrate rich juices and soups free of solid to bring the blood glucose level at a consistent level of 5 to 10 mM (90-180 mg/dL) so that blood glucose level detectors at brain hunger at hypothalamus and brain stem are satisfied and brain does not order the release of stored glycogen from muscles and liver enabling the muscles to work without being tired. Due to the presence of stable blood glucose levels, the brain does not order the muscles to be degraded by liver enzymes to release sugar like products into the blood stream saving the muscle mass. Since the fasting person does not perceive hunger, the fasting can be continued for long durations like 90 days easily without feeling of hunger, deprivation or feelings of muscle weakness and tiredness. The hunger free fasting may be conducted for a number of days at the fasting person's home or in a fasting center or a hospital. [0026] Significant advantages are realized by practice of the present invention. In a preferred embodiment, the hunger minimized fasting system of the present invention comprises: 1) preparing fasting person for 3 to 5 days prior entering fasting phase; 2) providing liquefied vitamin and mineral supplement on a daily basis enabling production of numerous enzymes for use in glycolysis, the process of conversion blood glucose to pyruvic acid and adenosine triphosphate (ATP) as well as beta oxidation of fats in the TCA (Kreb) cycle; 3) consuming on a daily basis clear solid free vegetable soup of 8 to 12 ounces in the morning and before bed time and consuming juices every 2 to 4 hours during waking hours representing a caloric intake of only 800 to 1200 calories representing a deficit of 600 to 1400 calories maintain blood glucose levels in the range of 5 to 10 mM (90 to 180 mg/dL) preventing onset of hunger sensing mechanism present the brain hypothalamus and brain stem preventing or minimizing hunger sensation of the fasting person and the blood glucose entering anaerobic glycolysis process synthesizing pyruvic acid and two ATP molecules in the extramitochondrial portion of the cell; 4) absence of solid material in the digestive organs including stomach and intestine reducing or eliminating response from brain hunger sensing mechanism of gut sensors and hormones by K-cells and L-cells; 5) said reduction in calorie intake with blood sugar levels maintained in the satiety region causes fat molecules from fat storage to be released into the blood stream by hormone sensitive lipase with the help of adrenaline hormone and transported bound to serum albumin arriving at the extramitochondrial portion of the cell the very place where glycolysis produces ATP and is readily available, fatty acid reacts with ATP to give a fatty acyl adenylate, plus inorganic pyrophosphate, which then reacts with free coenzyme A to produce a fatty acyl-CoA ester plus adenosine monophosphate (AMP), precursor to ATP which enters the inner barrier of the mitochondria with the help of carnitine to form acylcarnitine during beta oxidation to produce acyl-CoA ester that undergoes TCA cycle with the mitochondria and producing many molecules of ATP, the essential constituent for all cell operations; and 6) exiting the fast follows the same procedure as the fast entry phase, but adding additional insoluble fibers such as whole flax seeds, chia seeds or bran flakes as well as adding pro-biotic microbes to adjust the digestive system into re-accepting solids; whereby said brain hunger sensing mechanism is minimized or prevented and glycogen is not depleted from muscles and liver allowing movement and exercise of the fasting person while all the muscle tissue are preserved from any muscle degradation. BRIEF DESCRIPTION OF THE DRAWINGS [0034] The invention will be more fully understood and further advantages will become apparent when reference is had to the following detailed description of the preferred embodiments of the invention and the accompanying drawing, in which: [0035] FIG. 1 illustrates the key features of the present invention wherein ATP is available at the extramitochondrial portion of the cell due to glycolysis of sugars and carbohydrates consumed and the fats also arrive at the same location allowing decomposed products of glycolysis and fat enter the mitochondria due to the presence of ATP; [0036] FIGS. 2A-1 and 2A-2 illustrate the steps of the Preparatory Phase of Glycolysis that occurs in the extramitochondrial portion of the cell showing loss of 2 ATP molecules; [0037] FIGS. 2B-1 and 2B-2 illustrate the steps of the Pay-off Phase of Glycolysis that occurs in the extramitochondrial portion of the cell showing gain of 4 ATP molecules; [0038] FIG. 3 illustrates the beta oxidation of fat brought onto a cell that occurs within the mitochondrial portion of the cell; and [0039] FIG. 4 illustrates the TCA cycle that occurs within the mitochondrial portion of the cell. DETAILED DESCRIPTION OF THE INVENTION [0040] This invention relates to a system for fasting during a prolonged period without hunger pangs and without becoming very tired or unable to move and exercise. The system also prevents the loss of muscle tissue while losing a significant amount of body weight which includes fat and water, on a daily basis, typically in the range of half to one pound. [0041] The present invention employs a unique approach during juice fasting that provides benefits to the person undergoing the procedure. It was surprisingly found that the degree of hunger perceived during juice fasting is dependent on numerous brain hunger sensing functions. The brain tissue has very little storage of glucose or glycogen or adenosine triphosphate (ATP) molecules and requires a continuous supply of glucose for functioning of the brain at about 5 mM or 90 mg/dL. As a primary sensing mechanism, the hypothalamus and brain stem monitors very closely the blood glucose or glycogen levels and provides strong hunger sensations when the blood glucose or glycogen levels are low, creating a strong urge to eat. If the glucose or glycogen levels are not replenished, the brain commands the muscles and liver to release stored glycogen into the blood stream. If this stored glycogen is unavailable the brain commands the liver to degrade muscles to produce glucose simulant at the expense of normally unused muscle tissue. Again, when the blood glucose or glycogen levels are high the insulin release is triggered converting the glucose or glycogen in the blood to be combined to form triglycerides which are transferred for storage as adipose tissue. In addition, the fat release mechanism is immediately stopped when blood glucose concentration is too high. Thus the key to hunger free fasting is to provide an adequate amount of blood glucose or glycogen levels to satisfy the brain's need for glucose without exceeding glucose levels that trigger a release of insulin resulting in the formation of triglycerides. Also, when high blood glucose levels are present, the release mechanism from fat storage is halted. The second key hunger sensing mechanism used by the brain is the detection of digestible material in the stomach and intestine promoting release of digestive enzymes as detailed in the article at “Brain Glucose Sensing, Counterregulation, and Energy Homeostasis” by Nell Marty, Michel Dallaporta and Bernard Thorens published in Physiology 22:241-251, 2007 available at http://physiologyonline.physiology.org/content/22/4/241. This requires the stomach and intestines to be free from solid material preventing hunger response and corresponding release of digestion hormones. The reference 78, Mei N. Vagal ‘glucoreceptors in the small intestine of the cat’. J Physiol 282: 485-506, 1978 relates to solids available at the intestines. [0042] Thus the strategies for hunger free fasting involve drinking cooked vegetable soup that is filtered of all solid material and 8 to 12 ounce of juice every 2 to 4 waking hours. Breakfast and pre-bedtime meal is essentially the vegetable filtered soup. The overall calories contained in the juice and vegetable soup is only in the range of 800 to 1200 calories leaving a calorie deficit of about 600 to 1400 calories for a person normally consuming 1800-2400 calories per day. [0043] The body requires these calories for the functioning of essential body functions including breathing, supporting the liver, heart and lung function as well as maintaining body temperature. This calorie deficiency has to be made up by use of body fat since fat is the primary fuel used by the body for all aerobic muscles, which contain fat burning brown muscle fibers interlaced with capillaries supplying blood oxygen rich blood. All cells and muscles performing steady work such as heart muscles and muscles that provide body stability are all aerobic muscles of this type. The next aspect of the present invention is to facilitate the release of fat in the form of tri-glycerides or mono-glycerides from lipid storage. [0044] The food consumed, whether in the form of carbohydrates or sugars, converts to glucose in the blood stream either rapidly or slowly depending on the glycemic index of the food consumed. Proteins are more slowly digested and also convert to glucose in the blood stream. Fats take a very long time to digest and enter the intestinal walls after enzyme action that breaks down fat into tri or mono glycerides. Fats do not convert to glucose in the blood stream. [0045] Since the amount of food in the stomach and intestine is reduced the ability to eliminate waste is minimized. Enemas or suppositories may be used to improve evacuation. [0046] The utilization and conversion of glucose and fats into adenosine triphosphate (ATP) through different initial pathways as detailed in FIGS. 1A-1, 1 -A- 2 , 1 B- 1 and 1 B- 2 are shown. The TCA cycle is illustrated in FIG. 2 which produces ATP in aerobic conditions. [0047] FIG. 1 illustrates a block diagram of the features of the subject invention. When the fasting person consumes a sugar rich and or carbohydrate rich juice or soup, the brain detection of hunger is satiated. This blood glucose is processed by glycolysis, which produces two pyruvic acid molecules and two ATP molecules per molecule of glucose. The pyruvic acid reacts with coenzyme A aided by ATP to produce acetyl CoA, which enters the mitochondria and undergoes TCA cycle producing a number of ATP molecules powering the cell operation. Since the amount of calories consumed by this juice and soup diet is smaller than that is required for the sustenance of the body, the deficient calories are obtained from fats. Hormone sensitive lipase is released at the fat reserves as mono and triglycerides and carried by the blood bound to serum albumen and delivered at the extramitochondrial portion of the cell. The released fat in the extramitochondrial region of the cell reacts with coenzyme A assisted by energy rich ATP molecule to form acyl CoA which enters the inner barrier of mitochondria assisted by carnitine. Within the mitochondria the acyl CoA converts to acetyl CoA, by the process known as beta oxidation, which is passed on to the TCA cycle producing a large number of ATP molecules. The key feature of the invention is making ATP available at all times due to consumption of sugar and carbohydrate rich juices and or soups ever two to 4 hours while at the same time limiting the total caloric intake so as to force the body to release fat from storage. The fat arrives at the extramitochondrial portion of the cell and is again processed due to the presence of ATP at this location. The fasting person does not feel hungry even after fasting for a number of days and the fat is drawn from fat reserves and used as calories, improving the weight and MBI of the person. The muscles of the fasting person are not degraded during fasting. [0048] FIGS. 2A-1 and 2A-2 illustrates the preparatory phase of glycolysis where two ATP molecules are consumed as shown in Steps 1 and 3 . A large number of enzymes are involved in Steps 1 through 5 of the preparatory phase each performing a specific function. [0049] FIGS. 2B-1 and 2B-2 illustrates the pay-off phase of glycolysis where four ATP molecules are produced as shown in Steps 7 and 10 . Thus the glycolysis, which is a combination of steps 1 through 10 produce two excess molecules of ATP. A large number of enzymes are involved both in the preparatory and payoff phases each performing a specific function. [0050] Glycolysis is an anaerobic metabolic pathway that has a sequence of 10 steps all of which are enzyme catalyzed. Accordingly, the sequence of these reactions converts glucose into pyruvate, producing two additional ATP molecules from each glucose molecule. This metabolic process produces high-energy compounds of ATP (Adenosine triphosphate) and NADH (nicotinamide adenine dinucleotide). This process is an anaerobic reaction; the presence or absence of oxygen does not alter the reaction. The process of glycolysis happens in the extramitochondrial portion of the cell, often referred to as the EMP pathway. Glucose undergoes partial oxidation to produce two molecules of pyruvic acid, which is the starting point of the tri-carboxylic acid cycle (TCA cycle), which is also known as the citric acid cycle or Kreb cycle. The TCA cycle takes place aerobically within the mitochondria portion of the cell. All these processes of glycolysis and the TCA cycle require a large number of enzymes which are all synthesized by the cells and liver. [0051] FIG. 3 illustrates the beta oxidation of fatty acids taken from slide number 29 of web page http://www.authorstream.com/Presentation/aSGuest38680-330425-beta-oxidation-lipids-education-ppt-powerpoint. Beta oxidation of fatty acids is shown in this figure. Long chain acyl-CoA is cycled through reactions 2 through 5 . Acyl-CoA is split off by thiolase as shown at reaction 5 . ATP is needed for the first step of the beta oxidation process outside the inner mitochondrial membrane as shown. Carnatine is needed for the entry of acyl-CoA into the inner mitochondrial membrane. The fatty acid is degraded to acetyl CoA and enters the citric acid cycle as shown. All the enzymes used outside the inner mitochondrial membrane have to be manufactured by liver and the cell. [0052] FIG. 4 illustrates the TCA cycle. This TCA cycle is detailed at the web page http://biology.tutorvista.com/cell/glycolysis.html. The citric acid cycle is a sequence of enzyme-catalyzed chemical reactions, which are used by all the aerobic organisms to produce energy. Energy is generated through the oxidation of acetate that is derived from carbohydrates, fats and proteins into carbon dioxide. Pyruvate molecules are created from glycolysis. In the presence of oxygen, pyruvate produces acetyl-CoA by reaction with coenzyme A consuming one ATP. The fats are also degraded to acetyl-CoA and brought into the mitochondria. In the presence of oxygen, the acetyl-CoA produced by glycolysis or fat degradation enters the citric acid cycle inside the matrix of the mitochondria and it gets oxidized to CO 2 , and also at the same time reduces NAD to NADH. H 2 O and CO 2 are the waste products created during this cycle. The cycle consists of eight steps, which are catalyzed by eight different enzymes. The steps are detailed below. [0053] Step 1: Synthesis of Citric Acid. This step of the Krebs cycle is an Aldol condensation reaction and it is an irreversible reaction. Oxaloacetic acid and the acetyl CoA condense to form citric acid in the presence of the enzyme citrate synthase. The net effect of this reaction is to join a two-carbon with a four-carbon molecule, which yields a six-carbon molecule which is the citric acid. This is called the synthesis of citric acid. [0054] Step 2: Dehydration of citrate. It is a reversible reaction. Under the action of the enzyme acotinase, citrate is isomerized to form isocitrate. [0055] Step 3: Oxidation and Decarboxylation of isocitrate. This reaction is catalyzed by the emzynie isocitrate dehydrogenase. This is an irreversible reaction where isocitrate undergoes oxidative decarboxylation yielding three NADH molecules. These are first NADH molecules produced in the cycle and also CO 2 . [0056] Step 4: Oxidative, decarboxylation of α-ketoglutarate The enzyme α-ketoglutarate dehydrogenase complex catalyzes the conversion of α-ketoglutarate to succinyl CoA. This reaction produces the second CO 2 and also the second NADH of the cycle. The coenzymes that are required in the reaction are thiamine pyrophosphate, lipoic acid, FAD, NAD+ and CoA. [0057] Step 5: Substrate level phosphorylation. This reaction is catalyzed by the enzyme succinyl-CoA synthetase. This reaction is exothermic and is GTP molecule, which is equivalent to ATP is generated in this reaction. The product of this reaction is succinic acid and GTP. [0058] Step 6: Oxidation. This reaction is catalyzed by the enzyme succinate dehydrogenase, in this reaction the final electron acceptor is the FAD coenzyme. This reaction yields two ATP molecules from the electron transport chain. [0059] Step 7: Hydration. The hydration reaction is catalyzed by the enzyme fumarase. The fumarate is hydrated to form L-Malate. [0060] Step 8: Oxidation. This is reversible reaction, catalyzed by the enzyme malate dehydrogenase. The malate is oxidized to form oxaloacetic acid. This is the final point of entry to the electron transport chain. This reaction generates the NADH and oxaloacetate. [0061] Accordingly one pyruvic acid molecule yields one ATP molecule and one GTP molecule, which is equivalent to ATP. Also, NADH is an energetic molecule capable of producing ATP. [0062] As indicated in http://en.wikipedia.org/wiki/Beta_oxidation a fat molecule produces a large number of ATP molecules. The ATP yield for every oxidation cycle is theoretically at maximum yield of 17, as NADH produces 3 ATP, FADH 2 produces 2 and a full rotation of the Citric Acid Cycle produces 12. In practice it's closer to 14 ATP for a full oxidation cycle as in practice the theoretical yield isn't attained, it's generally closer to 2.5 ATP per NADH molecule produced, 1.5 for each FADH 2 molecule produced and this equates to 10 ATP molecules per cycle of the TCA (according to the P/O ratio). [0063] As detailed at http://en.wikipedia.org/wiki/Beta_oxidation, beta-oxidation is the process by which fatty acid molecules are broken down in the mitochondria to generate acetyl-coA, which enters the citric acid cycle, and NADH and FADH 2 , which are used by the electron transport chain. Fatty Acid Catabolism involves three stages. The first stage of fatty acid catabolism is Beta-Oxidation. The second stage is acetyl CoA oxidation to carbon dioxide. The third stage is electron transfer from electron carriers to the electron transfer chain. Priming the fatty acid for oxidation is the ‘Carnitine Shuttle’. First Acyl CoA is transferred to the hydroxyl group of carnitine by carnitine palmitoyltransferase 1 (palmitoyltransferase) located on the outer mitochondrial membrane. Acylcarnitine is shuttled inside by a carnitine-acylcamitine translocase. Acylcarnitine is converted back to acyl CoA by carnitine acyltransferase (palmitoyltransferase) located on the inner mitochondrial membrane. The liberated carnitine returns to the cytosol for further transport of fatty acid. [0064] Once the fatty acid is inside the mitochondrial matrix, Beta Oxidation can begin. It has 4 steps. Step 1 of Beta-Oxidation: Long chain fatty acid is dehydrogenated to create a trans double bond between C2 and C3. This is catalyzed by the fatty acyl CoA dehydrogenase to produce trans-delta 2-enoyl CoA. It uses FAD as an electron acceptor and it is reduced to FADH 2 . Step 2 of Beta-Oxidation: Trans-delta 2 -enoyl CoA is hydrated at the double bond to produce L-B-hydroxyacyl CoA. This is catalyzed by enoyl CoA hydratase. Step 3 of Beta-Oxidation: L-B-hydroxyacyl CoA is dehydrogenated again to create B-ketoacyl CoA by B-hydroxyacyl CoA dehydrogenase. This enzyme uses NAD as an electron acceptor. Step 4 of Beta-Oxidation: Thiolysis occurs between C2 and C3 (alpha and beta carbons) of B-ket acyl CoA. Thiolase enzyme catalyzes the reaction when a new molecule of coenzyme A breaks the bond by nucleophilic attack on C3. This releases the first two carbon units, as acetyl CoA, and a fatty acyl CoA minus two carbons. The process continues until all of the carbons in the fatty acid are turned into acetyl CoA. Acetyl CoA is the starting point for the TCA cycle as shown above. [0065] The following examples are presented to provide a more complete understanding of the invention. The specific techniques, conditions, materials, proportions and reported data set forth to illustrate the principles and practice of the invention are exemplary and should not be construed as limiting the scope of the invention. [0066] The fasting program of the subject invention can be practiced for a long time without hunger pangs, loss of muscle as detailed in actual test case results. EXAMPLE 1 [0067] The first test subject is male 40 years old who conducted a fasting study by fasting for 11 weeks followed by monitoring the body for 12 additional weeks following the fast. The following table 1 details the results. The fast was started on Jun. 8, 2013 and terminated on Aug. 17, 2013 representing a weight loss of (84-68) or 16 kilograms or 35 pounds. The measured fat percentile, as measured at a professional gym, decreased from 18% at the start of the fast to 5% at the end of the 70-day fast, Having changed the eating habits due to this prolonged fast, the weight and body fat contained remained stable as shown in the table. The percent of muscle during fast did not decrease, but increased as shown due to loss of body weight and remained stable for the 12 weeks after ending the fast. [0000] TABLE 1 Body Body Week fat % muscle % Date # Kg Lbs kg fat kg muscle Begin Fast Jun. 8, 2013 1 84 184.8 15.1 18%  39.4 47% Jun. 15, 2013 2 81 178.2 12.2 15%  39.3 49% Jun. 22, 2013 3 77.1 169.6 8.3 11%  39.3 51% Jun. 29, 2013 4 76 167.2 7.5 10%  39.1 51% Jul. 6, 2013 5 74.1 163.0 6.9 9% 38.2 52% Jul. 13, 2013 6 72.6 159.7 4.8 7% 38.5 53% Jul. 20, 2013 7 71.5 157.3 4.6 6% 38 53% Jul. 27, 2013 8 69.7 153.3 4.9 7% 36.8 53% Aug. 3, 2013 9 69.5 152.9 4.1 6% 37.1 53% Aug. 13, 2013 10 67.7 148.9 3.3 5% 36.5 54% Aug. 17, 2013 11 68 149.6 3.5 5% 36.3 53% End Fast Aug. 24, 2013 12 69.1 152.0 2.8 4% 37.1 54% Sep. 1, 2013 13 70.3 154.7 2.8 4% 38 54% Sep. 8, 2013 14 70.4 154.9 3.1 4% 38 54% Sep. 14, 2013 15 70.6 155.3 3.4 5% 37.9 54% Sep. 21, 2013 16 70.5 155.1 3 4% 38.2 54% Sep. 18, 2013 17 72.3 159.1 2.3 3% 39.6 55% Oct. 5, 2013 18 72.6 159.7 2.7 4% 39.6 55% Oct. 12, 2013 19 72.4 159.3 3.7 5% 39 54% Oct. 19, 2013 20 72.4 159.3 3.4 5% 39.1 54% Oct. 27, 2013 21 72.9 160.4 3 4% 39.9 55% Nov. 2, 2013 22 73.1 160.8 2.8 4% 39.9 55% Nov. 9, 2013 23 73.6 161.9 3.4 5% 39.9 54% EXAMPLE 2 [0068] A second subject is a 70 years old male that conducted a fasting study for 17 days. The daily weight data is shown in Table 2. The first three days represent the pre fast period and fasting is done for 8 days. The next three days were spent readjusting to a normal diet. Even this short fast resulted in a weight loss of (171-158,8) or 12,2 pounds. During fasting it was clearly apparent that exercise could be done. [0000] TABLE 2 Jog/walk distance Date day # Pounds (mi) Pre-Fast Jun. 11, 2014 1 171 2.5 Jun. 12, 2014 2 169 2.5 Jun. 13, 2014 3 168 — Begin Fast Jun. 14, 2014 4 167 2.5 Jun. 15, 2014 5 166 8.0 Jun. 16, 2014 6 165.2 2.5 Jun. 17, 2014 7 163.8 3.5 Jun. 18, 2014 8 163.2 3.4 Jun. 19, 2014 9 161.2 3.8 Jun. 20, 2014 10 160.4 3.4 Jun. 21, 2014 11 158.8 5.2 End Fast Jun. 22, 2014 12 158.8 2.5 Jun. 23, 2014 13 159.4 2.5 Jun. 24, 2014 14 159.4 2.5 Jun. 25, 2014 15 161.0 3.0 Jun. 26, 2014 16 161.5 2.5 Jun. 27, 2014 17 162.4 2.0 [0069] Having thus described the invention in rather full detail, it will be understood that such detail need not be strictly adhered to, but that additional changes and modifications may suggest themselves to one skilled in the art, all falling within the scope of the invention as defined by the subjoined claims.

1a

BACKGROUND OF THE INVENTION [0001] The present invention pertains to the endeavor to create a decorative and useful portable perch and recreation stand for pet birds. [0002] Pet bird playstands and perches are commonly manufactured for market. A simple perch is useful for interacting with a pet bird at eye level and may have a single horizontal branch and a horizontal pan or tray below to contain waste. More complex perches, which may be referred to as ‘playstands’, are useful also for providing recreation, and may have many branches. However, these branches tend to accumulate droppings from the bird perched on branches above. Also, the more branches there are, the larger is the footprint that requires waste containment below, thus reducing portability. [0003] Traditional means for waste containment consists of a durable solid surface that is oriented horizontally. This orientation allows for viewing of unpleasant waste material from any viewpoint and commonly allows the pet bird to walk on this surface resulting in waste material being disturbed. [0004] Examining the functionality of these products available today gives cause to the endeavor of the present invention. One objective of the endeavor is to maximize the amount of climbing and perching surface areas for a bird while minimizing opportunities for these surfaces to accumulate bird droppings. Another objective of the endeavor is to minimize the visual profile of the waste containment means while also minimizing the field of view of the waste itself. Still another objective is to provide waste containment means wherein a bird has minimized interest in traversing the surface where waste material is contained. BRIEF SUMMARY OF THE INVENTION [0005] The objectives of the present invention are met by combining two technologies; claims 1 and 2 describe similar Perch Systems, while claims 3 and 4 describe means of Waste Containment. Both technologies are independent, meaning they can stand alone or be combined with other technologies. BRIEF DESCRIPTION OF THE DRAWINGS [0006] FIG. 1 is a perspective view of the Perch System as described in claim 1 with Waste Containment [0007] FIG. 2 is a side elevation view of the Perch System as described in claim 1 with Waste Containment [0008] FIG. 3 is a front elevation view of the Perch System as described in claim 1 with Waste Containment [0009] FIG. 4 is a perspective view of the Perch System as described in claim 2 with Waste Containment in varied positions. [0010] FIG. 5 shows alternative Waste Containment surfaces conforming to the cross sectional profile as described in claim 3 DESCRIPTIONS FOR LETTER REFERENCES IN ALL DRAWINGS ARE CONSISTENT [0000] (A) Designates the base (B) Designates the pivoting means (C) Designates means of flexure (D) Designates the axis of rotation (E) Designates the main branch (F) Designates a typical secondary branch (G) Designates the gravitational vector (H) Designates the waste containment surface (J) Designates the primary crease (K) Designates means of fastening a lining material DETAILED DESCRIPTION OF THE INVENTION [0021] No claim is made regarding the process of manufacturing the present invention or the materials used. The elements that distinguish the present invention from prior art are what is claimed regardless of their material composition or fabrication method. Referring to the present invention as depicted in the drawings: [0022] The base (A) is preferably a decorative wooden board substantially centered below the center of gravity of the perch system (E)(F). The base may also be a mass with a smaller perimeter but with enough weight to prevent the perch system from overturning. Or the base can be a permanent foundation. [0023] Regardless of what the base is, the base is that to which pivoting means (B) is affixed. Pivoting means preferably is a ½ inch steel rod protruding from the base approximately 5½ inches with a smooth flat top upon which the weight of the perch system (E)(F) above bears. But there are many other ways, such as a thrust bearing, to implement the claimed pivoting means (B). [0024] The main branch (E) as depicted in the drawing is preferably a branch of dried wood extending approximately 5 feet and has a ½ inch hole in the lower end. The hole being shallower than the protruding length of the steel rod allows the main branch to rotate freely on the rod. It should be noted that the main branch need not be concentric with the axis of rotation (D). In fact, what is called the main branch may itself branch into separate trunks. Whatever the geometry of the main branch, it is that component which is rotatably attached to the pivoting means. [0025] The axis of rotation (D) is chosen to be less than vertical so that the weight of a bird will cause the perch system (E)(F) to rotate. If the inclination of the axis of rotation (D) is too far from vertical, the geometry of the perch system is limited; therefore 75% to 95% inclination is preferable. [0026] Secondary branches (F) are fastened to the main branch such that the weight of all the branches including the main branch is substantially balanced about the axis of rotation (D). Also, the branches (E)(F) are arranged such that when a bird is perched and gravity (G) causes the perch system to rotate, the bird will not be positioned above another branch but will be in a position directly above the waste containment surface (H). It should be noted that although it is preferable to make each instance of the present invention unique by assembling the perch system according to the random geometry found in natural wood materials and allowing for artistic expression, the perch system may be fabricated of predesigned components of any material. [0027] The waste containment surface (H) is preferably composed of a coated wire mesh screen bounded by an aluminum frame, which is then bent to the profile shown in FIG. 5A . The configuration of this bent surface directs waste material to the primary crease (J) and allows the waste to be hidden from view when the viewer stands far away, approximately 10 feet. Also the sloping sides discourage a bird from traversing the surface and disturbing the waste material. [0028] A paper liner is preferably placed over the surface for convenient waste disposal and any means to fasten the liner in place (K) may or may not be provided; both methods are claimed. No claim is made about the necessity for a lining material; for example, the surface can be made of a durable solid surface that is easily rinsed clean. Substantial compliance to the described cross sectional profile is what is claimed. [0029] The basic cross sectional profile shown in FIG. 5A may be improved as shown in FIG. 5B by creating slightly steeper slopes near the primary crease (J) so as to further discourage birds from traversing the surface and for improved appearance. However this alternative shape is in substantial compliance to the basic cross sectional profile as claimed. [0030] Because a paper liner conforms better to a surface that is curved in only one direction, the cross sectional profile is applied in one direction for surface that requires a liner. But in case a solid surface is chosen and a liner is omitted, the cross sectional profile may be applied in various directions or swept around the perimeter to form the waste containment surface. Any substantial application of the described cross sectional profile is what is claimed. [0031] FIG. 4 shows the perch system as described in claim 2 . It varies from the perch system as described in claim 1 because it does not rotate on the base (A), rather it tilts slightly in all directions by means of flexure (C) which is preferably implemented with a medium duty steel compression spring. Pivoting means (B) is preferably a ½ inch steel rod with a lower shoulder upon which the weight of the waste containment bears and is allowed to rotate freely. Also, pivoting means (B) is preferably affixed to the means of flexure (C) below and affixed to the perch system (E)(F) above while allowing the waste containment to rotate freely. The pivoting means described in this claim may be situated anywhere along the lower extremity of the main branch (E). However or wherever the pivoting means is implemented, it establishes an axis of rotation (D) about which the weight of the perch system must be substantially balanced. In this case, the weight of a bird causes the perch system and axis of rotation (D) to tilt, the waste containment will rotate to a position directly below the bird thereby satisfying the smallest possible waste containment surface for a given perch system.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This patent application is a continuation in part of Ser. No. 10/672,499, filed Sep. 26, 2003, which is a continuation of Ser. No. 10/346,828, filed Jan. 16, 2003, now U.S. Pat. No. 6,767,920, which is a continuation in part of Ser. No. 09/882,720, filed Jun. 14, 2001, now abandoned. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to 3, 7 or 3 and 7 thia or oxa prostanoic acid derivatives for the treatment of glaucoma or elevated intraocular pressure in combination with another drug. [0004] 2. Description of Related Art [0005] Prostaglandins can be described as derivatives of prostanoic acid which have the following structural formula: [0006] Various types of prostaglandins are known, depending on the structure and substituents carried on the alicyclic ring of the prostanoic acid skeleton. Further classification is based on the number of unsaturated bonds in the side chain indicated by numerical subscripts after the generic type of prostaglandin [e.g. prostaglandin E 1 (PGE 1 ), prostaglandin E 2 (PGE 2 )], and on the configuration of the substituents on the alicyclic ring indicated by α or β [e.g. prostaglandin F 2α (PGF 2β )]. [0007] Prostaglandins are useful for the long-term medical management of glaucoma (see, for example, Bito, L. Z. Biological Protection with Prostaglandins, Cohen, M. M., ed., Boca Raton, Fla., CRC Press Inc., 1985, pp. 231-252; and Bito, L. Z., Applied Pharmacology in the Medical Treatment of Glaucomas Drance, S. M. and Neufeld, A. H. eds., New York, Grune & Stratton, 1984, pp. 477-505. Such prostaglandins include PGF2α, PGF 1α , PGE 2 , and certain lipid-soluble esters, such as C 1 to C 2 alkyl esters, e.g. 1-isopropyl ester, of such compounds. [0008] EP 0 985 663 A1 discloses compounds such as the one shown below. [0009] Inflammatory bowel disease (IBD) is a group of disease characterized by inflammation in the large or small intestines and is manifest in symptoms such as diarrhea, pain, and weight loss. Nonsteroidal anti-inflammatory drugs have been shown to be associated with the risk of developing IBD, and recently Kabashima and colleagues have disclosed that “EP4 works to keep mucosal integrity, to suppress the innate immunity, and to downregulate the proliferation and activation of CD4+ T cells. These findings have not only elucidated the mechanisms of IBD by NSAIDs, but also indicated the therapeutic potential of EP4-selective agonists in prevention and treatment of IBD.” (Kabashima, et. al., The Journal of Clinical Investigation, April 2002, Vol. 9, 883-893) SUMMARY OF THE INVENTION [0010] Methods are disclosed herein comprising administering a compound and a second drug to an eye of a mammal for the treatment of glaucoma or the reduction of intraocular pressure said compound represented by the general formula I; wherein hatched lines represent the α configuration, a triangle represents the β configuration, a wavy line represents either the α configuration or the β configuration and a dotted line represents the presence or absence of a double bond; A and B are independently selected from the group consisting of O, S and CH 2 ; provided that at least one of A or B is S; D represents a covalent bond or CH 2 , O, S or NH; X is CO 2 R, CONR 2 , CH 2 OR, P(O)(OR) 2 , CONRSO 2 R, SONR 2 or Y is O, OH, OCOR 2 , halogen or cyano; Z is CH 2 or a covalent bond; R is H or R 2 ; R 1 is H, R 2 , phenyl, or COR 2 ; R 2 is C 1 -C 5 lower alkyl or alkenyl; R 3 is benzothienyl, benzofuranyl, naphthyl, or substituted derivatives thereof, wherein the substituents maybe selected from the group consisting of C 1 -C 5 alkyl, halogen, CF 3 , CN, NO 2 , NR 2 , CO 2 R and OR; and, R 4 is hydrogen or C 1 -C 5 alkyl. [0023] Compositions, medicaments, and dosage forms related thereto are also disclosed. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0024] FIG. 1 is a schematic of the chemical synthesis of a certain intermediate for the compounds of the invention as disclosed in Examples 1 through 3. [0025] FIG. 2 is a schematic of the chemical synthesis of certain compounds related to the compounds of the invention as disclosed in Examples 4 through 7. DETAILED DESCRIPTION OF THE INVENTION [0026] The compounds used for the treatment of glaucoma in combination with other therapeutic agents are encompassed by the following structural formula I: [0027] A preferred group of the compounds of the present invention includes compounds that have the following structural formula II: [0028] Another preferred group includes compounds having the formula III: [0029] In the above formulae, the substituents and symbols are as hereinabove defined. [0030] In the above formulae: [0031] Preferably A and B are both S. [0032] Preferably D represents a covalent bond or is CH 2 ; more preferably D is CH 2 . [0033] Preferably Z represents a covalent bond. [0034] Preferably R is H. [0035] Preferably R 1 is H. [0036] Preferably R 4 is hydrogen or methyl, most preferably hydrogen. [0037] Preferably Y═O. [0038] Preferably X is CO 2 R and more preferably R is selected from the group consisting of H, methyl, i-propyl and n-propenyl. [0039] The above compounds of the present invention may be prepared by methods that are known in the art or according to the working examples below. The compounds, below, are especially preferred representative, of the compounds of the present invention. {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid isopropyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid isopropyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzofuranyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzofuranyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzofuranyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid isopropyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-2-((E)-4-Benzo[b]thiophen-3-yl-3-hydroxybut-1-enyl)-3-hydroxy-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-2-((E)-4-Benzo[b]thiophen-3-yl-3-hydroxybut-1-enyl)-3-hydroxy-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-3-methyl-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester, {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-3-methyl-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(naphthyl)but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid, {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester and {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester. [0059] Second drugs useful for the treatment of glaucoma or other conditions include, but are not limited to. [0060] For the treatment of glaucoma, combination treatment with the following classes of drugs are contemplated: β-Blockers (or β-adrenergic antagonists) including carteolol, levobunolol, metiparanolol, timolol hemihydrate, timolol maleate, β1-selective antagonists such as betaxolol, and the like, or pharmaceutically acceptable salts or prodrugs thereof; Adrenergic Agonists including non-selective adrenergic agonists such as epinephrine borate, epinephrine hydrochloride, and dipivefrin, and the like, or pharmaceutically acceptable salts or prodrugs thereof; and α 2 -selective adrenergic agonists such as apraclonidine, brimonidine, and the like, or pharmaceutically acceptable salts or prodrugs thereof; Carbonic Anhydrase Inhibitors including acetazolamide, dichlorphenamide, methazolamide, brinzolamide, dorzolamide, and the like, or pharmaceutically acceptable salts or prodrugs thereof; Cholinergic Agonists including direct acting cholinergic agonists such as carbachol, pilocarpine hydrochloride, pilocarbine nitrate, pilocarpine, and the like, or pharmaceutically acceptable salts or prodrugs thereof; chlolinesterase inhibitors such as demecarium, echothiophate, physostigmine, and the like, or pharmaceutically acceptable salts or prodrugs thereof; Glutamate Antagonists and other neuroprotective agents such as Ca 2+ channel blockers such as memantine, amantadine, rimantadine, nitroglycerin, dextrophan, detromethorphan, CGS-19755, dihydropyridines, verapamil, emopamil, benzothiazepines, bepridil, diphenylbutylpiperidines, diphenylpiperazines, HOE 166 and related drugs, fluspirilene, eliprodil, ifenprodil, CP-101,606, tibalosine, 2309BT, and 840S, flunarizine, nicardipine, nifedimpine, nimodipine, barnidipine, verapamil, lidoflazine, prenylamine lactate, amiloride, and the like, or pharmaceutically acceptable salts or prodrugs thereof; Prostamides such as bimatoprost, or pharmaceutically acceptable salts or prodrugs thereof; Prostaglandins including travoprost, UFO-21, chloprostenol, fluprostenol, 13,14-dihydro-chloprostenol, latanoprost and the like; isopropyl unoprostone; and Cannabinoids including CB1 agonists such as WIN-55212-2 and CP-55940 and the like, or pharmaceutically acceptable salts or prodrugs thereof. [0074] For treatment of diseases affecting the eye including glaucoma, these compounds can be administered topically, periocularly, intraocularly, or by any other effective means known in the art. The compounds disclosed herein may be administered topically, periocularly, or by intraocular injection. Delivery may be by sustained release. For example, the drug may be delivered via a sustained release polymer, where the drug is released over time by diffusion of the drug from the polymer or degradation of the polymer. The polymer might be injected or implanted anywhere in or around the eye, including the subconjunctival or subtenons space. [0075] Pharmaceutical compositions may be prepared by combining a therapeutically effective amount of at least one compound according to the present invention, or a pharmaceutically acceptable acid addition salt thereof, as an active ingredient, with conventional ophthalmically acceptable pharmaceutical excipients, and by preparation of unit dosage forms suitable for topical ocular use. The therapeutically efficient amount typically is between about 0.0001 and about 5% (w/v), preferably about 0.001 to about 1.0% (w/v) in liquid formulations. [0076] For topical ophthalmic application, preferably solutions are prepared using a physiological saline solution as a major vehicle. The pH of such ophthalmic solutions should preferably be maintained between 6.5 and 7.2 with an appropriate buffer system. The formulations may also contain conventional, pharmaceutically acceptable preservatives, stabilizers and surfactants. [0077] Preferred preservatives that may be used in the pharmaceutical compositions of the present invention include, but are not limited to, benzalkonium chloride, chlorobutanol, thimerosal, phenylmercuric acetate and phenylmercuric nitrate. A preferred surfactant is, for example, Tween 80. Likewise, various preferred vehicles may be used in the ophthalmic preparations of the present invention. These vehicles include, but are not limited to, polyvinyl alcohol, povidone, hydroxypropyl methyl cellulose, poloxamers, carboxymethyl cellulose, hydroxyethyl cellulose and purified water. [0078] Tonicity adjustors may be added as needed or convenient. They include, but are not limited to, salts, particularly sodium chloride, potassium chloride, mannitol and glycerin, or any other suitable ophthalmically acceptable tonicity adjustor. [0079] Various buffers and means for adjusting pH may be used so long as the resulting preparation is ophthalmically acceptable. Accordingly, buffers include acetate buffers, citrate buffers, phosphate buffers and borate buffers. Acids or bases may be used to adjust the pH of these formulations as needed. [0080] In a similar vein, an ophthalmically acceptable antioxidant for use in the present invention includes, but is not limited to, sodium metabisulfite, sodium thiosulfate, acetylcysteine, butylated hydroxyanisole and butylated hydroxytoluene. [0081] Other excipient components which may be included in the ophthalmic preparations are chelating agents. The preferred chelating agent is edentate disodium, although other chelating agents may also be used in place or in conjunction with it. [0082] The ingredients are usually used in the following amounts: Ingredient Amount (% w/v) active ingredient about 0.001-5 preservative 0-0.10 vehicle 0-40 tonicity adjustor 1-10 buffer 0.01-10 pH adjustor q.s. pH 4.5-7.5 antioxidant as needed surfactant as needed purified water as needed to make 100% [0083] The actual dose of the active compounds of the present invention depends on the specific compound, and on the condition to be treated; the selection of the appropriate dose is well within the knowledge of the skilled artisan. [0084] The ophthalmic formulations of the present invention are conveniently packaged in forms suitable for metered application, such as in containers equipped with a dropper, to facilitate the application to the eye. Containers suitable for dropwise application are usually made of suitable inert, non-toxic plastic material, and generally contain between about 0.5 and about 15 ml solution. [0085] Those skilled in the art will readily understand that for oral or rectal administration the compounds of the invention are admixed with pharmaceutically acceptable excipients which per se are well known in the art. Specifically, a drug to be administered systemically, it may be confected as a powder, pill, tablet or the like, or as a syrup or elixir suitable for oral administration. Description of the substances normally used to prepare tablets, powders, pills, syrups and elixirs can be found in several books and treatise well known in the art, for example in Remington's Pharmaceutical Science, Edition 17, Mack Publishing Company, Easton, Pa. [0086] Parenteral administration is generally characterized by injection. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for dissolving or suspending in liquid prior to injection, or as emulsions. Descriptions of substances and methods normally used to prepare formulations for parenteral administration can be found in several treatises and books well known in the art such as, Handbook On Injectable Drugs (11th edition), edited by Lawrence A. Trissel, (Chicago: Login Brothers Book Company; Jan. 15, 2001). [0087] The invention is further illustrated by the following non-limiting Examples, which are summarized in the reaction schemes of FIGS. 1 and 2 wherein the compounds are identified by the same designator in both the Examples and the Figures. EXAMPLE 1 (R)-4-(tert-Butyldimethylsilanyloxy)cyclopent-2-enone (2) [0088] Tetrapropylammonium perruthenate (9.4 mg, 0.027 mmol) was added to a mixture of (1S,4R)-4-(tert-butyldimethylsilanyloxy)cyclopent-2-enol prepared, according to Tetrahedron Letters, Vol. 37, No. 18, 1996, pp. 3083-6, (118.6 mg, 0.54 mmol), 4-methylmorpholine N-oxide (94.9 mg, 0.81 mmol) and crushed 4 Å sieves (270 mg) in CH 2 Cl 2 (10 mL). The mixture was stirred for 30 min and was passed through a plug of silica gel with CH 2 Cl 2 . The filtrate was concentrated in vacuo to give 100 mg (86%) of the above titled compound. EXAMPLE 2 (R)-4-(tert-Butyldimethylsilanyloxy)-6-oxabicyclo[3.1.0]hexan-2-one (3) [0089] Hydrogen peroxide (4.5 mL, 46.3 mmol, 30% wt. % solution in water) and 1N NaOH (46 μL, 0.046 mmol) were added to a solution of enone 2 (2.5 g, 11.5 mmol) in MeOH (30 mL) at 0° C. After stirring 1.5 h at 0° C. the mixture was concentrated in vacuo, washed with saturated aqueous NH 4 Cl and extracted with CH 2 Cl 2 (3×). The combined organics were washed with brine, dried (Na 2 SO 4 ), filtered and concentrated in vacuo to afford the above titled compound. EXAMPLE 3 ({3-[(R)-3-(tert-Butyldimethylsilanyloxy)-5-oxocyclopent-1-enylsulfanyl]propyl-sulfanyl}acetic acid methyl ester (5) [0090] The epoxide 3 prepared above was diluted with CH 2 Cl 2 (30 mL), (3-mercaptopropylsulfanyl)acetic acid methyl ester 4 (1.93 g, 10.7 mmol), prepared according to Chem. Pharm. Bull. 28 (2), 1980, 558-566, was added and the solution was cooled to 0° C. Basic alumina (11.9 g) was added and the reaction mixture was warmed to room temperature. After stirring for 18 h the mixture was filtered through celite and concentrated in vacuo. The residue was purified by flash column chromatography (silica gel, 6:1 hex/EtOAc) to yield 3.6 g (80%) of the above titled compound. EXAMPLE 4 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)oct-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (7) [0091] tert-Butyllithium (1.47 mL of a 1.7M solution in pentane, 2.5 mmol) was added dropwise to a solution of tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane 6 (462.5 mg, 1.25 mmol) in Et 2 O (6.0 mL) at −78° C. After stirring for 30 min lithium 2-thienylcyanocuprate (6.0 mL of a 0.25M solution in THF, 1.5 mmol) was added and the reaction was stirred an additional 30 min at −78° C. A solution of enone 5 (430 mg, 1.1 mmol) in Et 2 O (1 mL) was added and stirring was continued for an additional 1 h. The reaction mixture was then quickly poured into saturated aqueous NH 4 Cl cooled to 0° C. The mixture was extracted with EtOAc and the organic portion was washed with brine, dried (Na 2 SO 4 ), filtered and concentrated in vacuo. The residue was quickly purified by flash column chromatography (silica gel, 100% hexane followed by 8:1 hex/EtOAc) to afford 270 mg (39%) of the above titled compound. EXAMPLE 5 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxyoct-1-enyl)-5-oxocyclopentyl-sulfanyl]propylsulfanyl}acetic acid methyl ester (8) [0092] Hydrogen fluoride-pyridine. (220 μL) was added to a solution of bis-TBDMS ether 7 (70 mg, 0.11 mmol) in CH 3 CN (2.0 mL) at 0° C. The reaction was warmed to room temperature, stirred 1 h, and recooled to 0° C. The reaction was quenched with saturated aqueous NaHCO 3 until gas evolution ceased. The mixture was extracted with CH 2 Cl 2 (4×). The combined organics were washed with brine, dried (Na 2 SO 4 ), filtered and concentrated in vacuo. Purification of the residue by flash column chromatography (silica gel, 100% CH 2 Cl 2 followed by 30:1 CH 2 Cl 2 :MeOH) provided 40 mg (90%) of the above titled compound. EXAMPLE 6 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxyoct-1-enyl)-5-oxocyclopentyl-sulfanyl]propylsulfanyl}acetic acid (9) [0093] Methyl ester 8 (50 mg, 0.124 mmol) was dissolved in CH 3 CN (10 mL) and pH 7.2 phosphate buffer (3.0 mL) was added. The mixture was treated with PLE (400 μL, 1.34 mol/L) and stirred for 16 h at 23° C. The reaction mixture was extracted with EtOAc (3×). The combined organics were washed with brine, dried (Na 2 SO 4 ), filtered and concentrated in vacuo. Purification of the residue by flash column chromatography (silica gel, 100% EtOAc) gave 5.3 mg (11%) of the above titled compound. EXAMPLE 7 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxyoct-1-enyl)-5-oxocyclopentyl-sulfanyl]propylsulfanyl}acetic acid isopropyl ester (10) [0094] Isopropyl-p-tolyltriazene (200 μL) was added dropwise to a solution of carboxylic acid 9 (10.5 mg, 0.026 mmol) in acetone (5.0 mL) at 23° C. After stirring for 1 h the reaction was quenched with 1N HCl and the solvent was removed in vacuo. The residue was extracted with CH 2 Cl 2 (2×). The combined organics were dried (Na 2 SO 4 ), filtered and concentrated in vacuo. Purification of the residue by flash column chromatography (silica gel, 4:1 hex/EtOAc) gave 4.3 mg (38%) of the above titled compound. EXAMPLE 8 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-5-(naphthyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (H) (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-5-(naphthyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (L) [0095] The named compound is prepared by substituting tert-butyl-[(E)-3-iodo-1-(2-naphthalen-2-yl-ethyl)allyloxy]dimethylsilane for tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L, respectively. EXAMPLE 9(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) [0096] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 8 (H) rather then the named compound of Example 4. EXAMPLE 9 (L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0097] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 8 (L) rather then the named compound of Example 4. EXAMPLE 10 (H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (H) [0098] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 9 (H) rather than the named compound of Example 5. EXAMPLE 10 (L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (L) [0099] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 9 (L) rather than the named compound of Example 5. EXAMPLE 11 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid isopropyl ester [0100] The named compound is prepared by repeating the method of Example 7 with the named compound of Example 10 rather than the named compound of Example 6. EXAMPLE 12 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-5-(benzothienyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (H) (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-5-(benzothienyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (L) [0101] The named compound is prepared by substituting [(E)-1-(2-Benzo[b]thiophen-2-yl-ethyl)-3-iodoallyloxy]-ter-butyldimethylsilane for tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L, respectively. EXAMPLE 13(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl)acetic acid methyl ester (H) [0102] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 12 (H) rather then the named compound of Example 4. EXAMPLE 13(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0103] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 12 (H) rather then the named compound of Example 4. EXAMPLE 14(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (H) [0104] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 13 (H) rather than the named compound of Example 5. EXAMPLE 14(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (L) [0105] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 13 (L) rather than the named compound of Example 5. EXAMPLE 15 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl)acetic acid isopropyl ester [0106] The named compound is prepared by repeating the method of Example 7 with the named compound of Example 14 rather than the named compound of Example 6. EXAMPLE 16 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-5-(benzofuranyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester [0107] The named compound is prepared by substituting [(E)-1-(2-Benzo[b]furan-2-yl-ethyl)-3-iodoallyloxy)-tert-butyldimethylsilane for tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. EXAMPLE 17 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzofuranyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester [0108] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 16 rather then the named compound of Example 4. EXAMPLE 18 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzofuranyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl)acetic acid [0109] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 17 rather than the named compound of Example 5. EXAMPLE 19 {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-hydroxy-5-(benzofuranyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid isopropyl ester [0110] The named compound is prepared by repeating the method of Example 7 with the named compound of Example 18 rather than the named compound of Example 6. EXAMPLE 20 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(E)-3-(tert-butyldimethylsilanoxy)-4-naphthalen-2-yl-but-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (H) (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(E)-3-(tert-butyldimethylsilanoxy)-4-naphthalen-2-yl-but-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (L) [0111] The named compound is prepared by substituting tert-butyl-((E)-3-iodo-1-naphthalen-2-yl-methylallyloxy)dimethylsilane for tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L, respectively. EXAMPLE 21 (H) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) [0112] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 20 (H) rather then the named compound of Example 4. EXAMPLE 21(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0113] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 20 (H) rather then the named compound of Example 4. EXAMPLE 22(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (H) [0114] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 21 (H) rather than the named compound of Example 5. EXAMPLE 22(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-4-naphthalen-2-yl-but-1-enyl)-5-oxocycldpentylsulfanyl]propylsulfanyl}acetic acid (L) [0115] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 21 (H) rather than the named compound of Example 5. EXAMPLE 23 {3-[(1R,2S,3R)-2-[(E)-4-Benzo[b]thiophen-3-yl-3-(tert-butyldimethylsilanyloxy)but-1-enyl]-3-(tert-butyldimethylsilanyloxy)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) {3-[(1R,2S,3R)-2-[(E)-4-Benzo[b]thiophen-3-yl-3-(tert-butyldimethylsilanyloxy)but-1-enyl]-3-(tert-butyldimethylsilanyloxy)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0116] The named compound is prepared by substituting ((E)-1-Benzo[b]thiophen-3-ylmethyl-3-iodo-allyloxy)-tert-butyldimethylsilane for tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L respectively. EXAMPLE 24(H) {3-[(1R,2S,3R)-2-((E)-4-Benzo[b]thiophen-3-yl-3-hydroxybut-1-enyl)-3-hydroxy-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) [0117] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 23 (H) rather then the named compound of Example 4. EXAMPLE 24(L) {3-[(1R,2S,3R)-2-((E)-4-Benzo[b]thiophen-3-yl-3-hydroxybut-1-enyl)-3-hydroxy-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0118] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 23 (H) rather then the named compound of Example 4. EXAMPLE 25(H) {3-[(1R,2S,3R)-2-((E)-4-Benzo[b]thiophen-3-yl-3-hydroxybut-1-enyl)-3-hydroxy-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (H) [0119] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 24 (H) rather than the named compound of Example 5. EXAMPLE 25(L) {3-[(1R,2S,3R)-2-((E)-4-Benzo[b]thiophen-3-yl-3-hydroxybut-1-enyl)-3-hydroxy-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (L) [0120] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 24 (H) rather than the named compound of Example 5. EXAMPLE 26 {3-[(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-3-(methyl)-5-(naphthyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (H) (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-3-(methyl)-5-(naphthyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (L) [0121] The named compound is prepared by substituting tert-Butyl-[(E)-3-iodo-1-methyl-1-(2-naphthalen-2-yl-ethyl)allyloxy]dimethylsilane for tert-butyl[(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L, respectively. EXAMPLE 27(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) [0122] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 26 (H) rather then the named compound of Example 4. EXAMPLE 27(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0123] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 26 (H) rather then the named compound of Example 4. Example 28(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl)acetic acid (H) [0124] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 27 (H) rather than the named compound of Example 5. EXAMPLE 28(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(naphthyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl)acetic acid (L) [0125] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 27(L) rather than the named compound of Example 5. EXAMPLE 29 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(E)-3-(tert-butyldimethylsilanoxy)-3-methyl-4-naphthalen-2-yl-but-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (H) (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(E)-3-(tert-butyldimethylsilanoxy)-3-methyl-4-naphthalen-2-yl-but-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (L) [0126] The named compound is prepared by substituting tert-butyl-[(E)-3-iodo-1-methyl-1-(2-naphthalen-2-yl-methyl)allyloxy]dimethylsilane for tert-butyl [(S)-1-((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L, respectively. EXAMPLE 30(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-3-methyl-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) [0127] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 29 (H) rather then the named compound of Example 4. EXAMPLE 30(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-3-methyl-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl)acetic acid methyl ester (L) [0128] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 29 (L) rather then the named compound of Example 4. EXAMPLE 31(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-3-methyl-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (H) [0129] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 30 (H) rather than the named compound of Example 5. EXAMPLE 31(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((E)-3-hydroxy-3-methyl-4-naphthalen-2-yl-but-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (L) [0130] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 30 (L) rather than the named compound of Example 5. EXAMPLE 32 (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-3-(methyl)-5-(benzylthienyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (H) (3-{(1R,2S,3R)-3-(tert-Butyldimethylsilanyloxy)-2-[(S)-(E)-3-(tert-butyldimethylsilanoxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl]-5-oxocyclopentylsulfanyl}propylsulfanyl)acetic acid methyl ester (L) [0131] The named compound is prepared by [(E)-1-(2-Benzo[b]thiophen-2-yl-ethyl)-3-iodo- 1-methylallyloxy]-tert-butyldimethylsilane for tert-butyl [(S)- 1 -((E)-2-iodovinyl)hexyloxy]dimethylsilane in the method of Example 4. FCC gives a higher Rf compound and a lower Rf compound, designated as H and L, respectively. EXAMPLE 33(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (H) [0132] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 32 (H) rather then the named compound of Example 4. EXAMPLE 33(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid methyl ester (L) [0133] The named compound is prepared by repeating the method of Example 5 with the named compound of Example 32 (L) rather then the named compound of Example 4. EXAMPLE 34(H) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (H) [0134] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 33 (H) rather than the named compound of Example 5. EXAMPLE 34(L) {3-[(1R,2S,3R)-3-Hydroxy-2-((S)-(E)-3-(hydroxy)-3-(methyl)-5-(benzothienyl)pent-1-enyl)-5-oxocyclopentylsulfanyl]propylsulfanyl}acetic acid (L) [0135] The named compound is prepared by repeating the method of Example 6 with the named compound of Example 33L rather than the named compound of Example 5. [0136] The compounds of the Examples are subject to in vitro testing as described below. The results are reported in the table as IC50s in nM. Example No. hEP 2 hEP 3 hEP 4 33H NA NA 200 33L NA NA 300 34H >>10 4 >10 4 34L NA >10 4 68 13H NA NA 91 13L >>10 4 7200 93 14H >>10 4 >10 4 27 14L 10 4 >10 4 13  9H NA NA 40  9L NA >10 4 40 10H >>10 4 >10 4 450 10L   >10 4 8300 19.5 27H NA NA 500 27L NA NA 3400 28H NA >10 4 1700 28L NA >10 4 1500 21H NA > 4 100 21L NA >10 4 13 22H NA >10 4 32 22L >>10 4 >10 4 6.2 30H NA >10 4 3100 30L NA NA 3200 31H NA 8100 300 31L NA 9300 900 24H NA NA 200 24L 9300 >10 4 30 25H   >10 4 NA 69 25L 2200 >10 4 5 Human Recombinant EP 1 , EP 2 , EP 4 , and FP Receptors: Stable Transfectants [0137] HEK-293 cells stably expressing the human or feline FP receptor, or EP 1 , EP 2 , EP 3 , or EP 4 receptors were washed with TME buffer, scraped from the bottom of the flasks, and homogenized for 30 sec using a Brinkman PT 10/35 polytron. TME buffer was added to achieve a final 40 ml volume in the centrifuge tubes (the composition of TME is 100 mM TRIS base, 20 mM MgCl 2 , 2M EDTA; ION HCl is added to achieve a pH of 7.4). [0138] The cell homogenate was centrifuged at 19000 r.p.m. for 20 min at 4° C. using a Beckman Ti-60 rotor. The resultant pellet was resuspended in TME buffer to give a final 1 mg/ml protein concentration, as determined by Biorad assay. Radioligand binding competition assays vs. [ 3 H-]17 -phenyl PGF 2α (5 nM) were performed in a 100 μl volume for 60 min. Binding reactions were started by adding plasma membrane fraction. The reaction was terminated by the addition of 4 ml ice-cold TRIS-HCl buffer and rapid filtration through glass fiber GF/B filters using a Brandel cell harvester. The filters were washed 3 times with ice-cold buffer and oven dried for one hour. Non-specific binding was determined with 10 uM unlabeled 17 -phenyl PGF 2α . [0139] [ 3 H-] PGE 2 (5 nM; specific activity 180 Ci mmol) was used as the radioligand for EP receptors. Binding studies employing EP 1 , EP 2 , EP 3 , EP 4 were performed in duplicate in at least three separate experiments. A 200 μl assay volume was used. Incubations were for 60 min at 25° C. and were terminated by the addition of 4 ml of ice-cold 50 mM TRIS-HCl, followed by rapid filtration through Whatman GF/B filters and three additional 4 ml washes in a cell harvester (Brandel). Non-specific binding determined with 10 −5 M of unlabeled PGE 2 . [0140] Plasmids encoding the human EP 1 , EP 2 , EP 4 , and FP receptors were prepared by cloning the respective coding sequences into the eukaryotic expression vector pCEP4 (Invitrogen). The pCEP4 vector contains an Epstein Barr virus (EBV) origin of replication, which permits episomal replication in primate cell lines expressing EBV nuclear antigen (EBNA-1). Similarly, competitive experiments were caried out using [3H]17-phenylPGF 2α at 5 nM in the presence of test ligands at various concentrations. Also non-specific binding was, determined in the presence of excess unlabeled PGF 2α (10 −5 M). [0141] It also contains a hygromycin resistance gene that is used for eukaryotic selection. The cells employed for stable transfection were human embryonic kidney cells (HEK-293) that were transfected with and express the EBNA-1 protein. These HEK-293-EBNA cells (Invitrogen) were grown in medium containing Geneticin (G418) to maintain expression of the EBNA-1 protein. HEK-293 cells were grown in DMEM with 10% fetal bovine serum (FBS), 250 μg ml G418 (Life Technologies) and 200 μg ml −1 gentamicin or penicillin/streptomycin. Selection of stable transfectants was achieved with 200 μg m −1 hygromycin, the optimal concentration being determined by previous hygromycin kill curve studies. [0142] For transfection, the cells were grown to 50-60% confluency on 10 cm plates. The plasmid pCEP4 incorporating cDNA inserts for the respective human prostanoid receptor (20 μg) was added to 500 μl of 250 mM CaCl 2 . HEPES buffered saline ×2 (2×HBS, 280 mM NaCl, 20 mM HEPES acid, 1.5 mM Na 2 HPO 4 , pH 7.05-7.12) was then added dropwise to a total of 500 μl, with continuous vortexing at room temperature. After 30 min, 9 ml DMEM were added to the mixture. The DNA/DMEM/calcium phosphate mixture was then added to the cells, which had been previously rinsed with 10 ml PBS. The cells were then incubated for 5 hr at 37° C. in humidified 95% air/5% CO 2 . The calcium phosphate solution was then removed and the cells were treated with 10% glycerol in DMEM for 2 min. The glycerol solution was then replaced by DMEM with 10% FBS. The cells were incubated overnight and the medium was replaced by DMEM/10% FBS containing 250 μg ml −1 G418 and penicillin/streptomycin. The following day hygromycin B was added to a final concentration of 200 μg ml −1 . [0143] Ten days after transfection, hygromycin B resistant clones were individually selected and transferred to a separate well on a 24 well plate. At confluence each clone was transferred to one well of a 6 well plate, and then expanded in a 10 cm dish. Cells were maintained under continuous hygromycin selection until use. [0000] Human Recombinant EP 3 and TP Receptors: Transient Transfectants. [0144] Plasmids encoding the human EP 3 (D isoform) or TP receptor were prepared by cloning the respective coding sequences into a pcDNA 3 vector (Invitrogen). COS-7 cells were transfected with pcDNA 3 containing cDNA encoding the EP 3 or TP receptor by employing the lipofectin method, according to the manufacturers instructions (Gibco). For radioligand binding studies, cells were harvested two days after transfection. [0145] Radioligand Binding [0146] Radioligand binding studies on plasma membrane fractions prepared from cells were performed as follows. Cells washed with TME buffer were scraped from the bottom of the plates and homogenized for 30 sec using a Brinkman PT 10/35 polytron. TME buffer was added as necessary to achieve a 40 ml volume in the centrifuge tubes. TME is comprised of 50 mM TRIS base, 10 mM MgCl 2 , 1 mM EDTA; pH 7.4 is achieved by adding 1 N HCl. The cell homogenate was centrifuged at 19,000 rpm for 20-25 min at 4° C. using a Beckman Ti-60 or Tι-70 rotor. The pellet was then resuspended in TME buffer to provide a final protein concentration of 1 mg/ml, as determined by Bio-Rad assay. Radioligand binding assays were performed in a 100 μl or 200 μl volume. [0147] The binding of [ 3 H] PGE 2 (specific activity 165 Ci/mmol) was determined in duplicate and, in at least 3 separate experiments. Incubations were for 60 min at 25° C. and were terminated by the addition of 4 ml of ice-cold 50 mM TRIS-HCl followed by rapid filtration through Whatman GF/B filters and three additional 4 ml washes in a cell harvester (Brandel). Competition studies were performed using a final concentration of 2.5 or 5 nM [H] PGE 2 and non-specific binding was determined with 10 −5 M unlabelled PGE 2 . [0148] The binding of [ 3 H]-SQ29548 (specific activity 41.5 Ci mmol '1 ) at TP receptors were determined in duplicate in at least three separate experiments. Radiolabeled SQ29548 was purchased from New England Nuclear. Incubations were for 60 min at 25° C. and were terminated by the addition of 4 ml of ice-cold 50 mM TRIS-HCl, followed by rapid filtration through Whatman GF/B filters and three additional 4 ml washes in a cell harvester (Brandel). Competition studies were performed using a final concentration of 10 nM [ 3 H]-SQ 29548 and non-specific binding determined with 10 μM of the unlabeled prostanoid. For all radioligand binding studies, the criteria for inclusion were >50% specific binding and between 500 and 1000 displaceable counts or better. [0149] The foregoing description details specific methods and compositions that can be employed to practice the present invention, and represents the best mode contemplated. However, it is apparent for one of ordinary skill in the art that further compounds with the desired pharmacological properties can be prepared in an analogous manner, and that the disclosed compounds can also be obtained from different starting compounds via different chemical reactions. Similarly, different pharmaceutical compositions may be prepared and used with substantially the same result. Thus, however detailed the foregoing may appear in text, it should not be construed as limiting the overall scope hereof; rather, the ambit of the present invention is to be governed only by the lawful construction of the appended claims.

1a

This application is a continuation of application Ser. No. 09/679,911, filed Oct. 5, 2000 now U.S. Pat. No. 6,676,682, which is a continuation of Ser. No. 09/421,138, filed Oct. 19, 1999, now U.S. Pat. No. 6,165,200, which in turn is a continuation of application Ser. No. 09/287,217, filed Apr. 5, 1999, now U.S. Pat No. 6,027,520, which is a continuation of application Ser. No. 09/022,510, filed Feb. 12, 1998, now U.S. Pat. No. 5,910,154, which is a continuation of application Ser. No. 08/852,867, filed May 8, 1997, now U.S. Pat. No. 5,911,734. Each of the above applications is hereby expressly and fully incorporated herein by reference. FIELD OF THE INVENTION The present invention relates generally to treating plaque deposits and occlusions within major blood vessels, more particularly to an apparatus and method for preventing detachment of mobile aortic plaque within the ascending aorta, the aortic arch, or the carotid arteries, and to an apparatus and method for providing a stent and a filter in a percutaneous catheter for treating occlusions within the carotid arteries. BACKGROUND OF THE INVENTION Several procedures are now used to open stenosed or occluded blood vessels in a patient caused by the deposit of plaque or other material on the walls of the blood vessels. Angioplasty, for example, is a widely known procedure wherein an inflatable balloon is introduced into the occluded region. The balloon is inflated, dilating the occlusion, and thereby increasing intraluminal diameter. Plaque material may be inadvertently dislodged during angioplasty, and this material is then free to travel downstream, possibly lodging within another portion of the blood vessel or possibly reaching a vital organ, causing damage to the patient. In another procedure, stenosis within arteries and other blood vessels is treated by permanently or temporarily introducing a stent into the stenosed region to open the lumen of the vessel. The stent typically comprises a substantially cylindrical tube or mesh sleeve made from such materials as stainless steel or nitinol. The design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size. Generally, a stent having a length longer than the target region is selected and is disposed on a catheter prior to use. The catheter typically has a flexible balloon, near its distal end, designed to inflate to a desired size when subjected to internal pressure. The stent is mounted to the catheter and compressed over the balloon, typically by hand, to assure that the stent does not move as it passes through the blood vessel to the desired location within the patient. Alternatively, self-expanding stents may also be used. The stent is typically introduced into the desired blood vessel using known percutaneous methods. The catheter, having the stent securely crimped thereon, is directed to the region of the blood vessel being treated. The catheter is positioned such that the stent is centered across the stenosed region. The balloon is inflated, typically by introducing gas or fluid such as saline solution, through a lumen in the catheter communicating with the balloon. Balloon inflation causes the stent to expand radially, thereby engaging the stenosed material. As the stent expands, the material is forced outward, dilating the lumen of the blood vessel. Due to substantial rigidity of the stent material, the stent retains its expanded shape, providing an open passage for blood flow. The balloon is then deflated and the catheter withdrawn. Because the stent is often constructed from a mesh material, the stent typically compresses longitudinally as it expands radially. Stenotic material trapped between the stent and the vessel wall may extend into the openings in the mesh and may be sheared off by this longitudinal compression to create embolic debris free. When this material travels downstream, it can cause serious complications. For example loose embolic material released within the ascending aorta, the aortic arch, or the carotid arteries may travel downstream to the brain, possibly causing stroke, which can lead to permanent injuries or even death of the patient. Thus, there is a need for an apparatus and method for delivering a stent into an arterial occlusion which substantially reduces the risk of embolic material escaping to the vessel and causing a blockage at a downstream location. There is also an apparatus and method for substantially preventing detachment of plaque deposited on the walls of the ascending aorta, the aortic arch, the descending aorta, and the carotid arteries. In addition, there is a need for an apparatus and method to substantially contain loose embolic material within the aorta and the carotid arteries during an interventional procedure, preventing it from reaching the brain. SUMMARY OF THE INVENTION The present invention provides an apparatus and method for preventing embolic material from escaping a site of intervention within the aorta, the carotid arteries, and other arteries generally, thereafter causing damage to vital organs, such as the brain. More particularly, the present invention involves an apparatus and method for introducing a stent into a region of a major blood vessel within the human body having plaque deposits, such as the ascending aorta, the descending aorta, aortic arch, common carotid artery, external and internal carotid arteries, brachiocephalic trunk, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral artery, basilar artery, subclavian artery, brachial artery, axillary artery, iliac artery, renal artery, femoral artery, popliteal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, anterior tibial artery, and posterior tibial artery, thereby opening occlusions and/or preventing embolic material from breaking free within the blood vessel. In a first embodiment, the invention includes a guidewire having an expandable filter attached to it, and a stent catheter. The catheter has an inflatable balloon mounted on or near its distal end, and an inflation lumen extending through the catheter between a proximal region of the catheter and the balloon. A stent is provided on the outer surface of the catheter, substantially engaging the balloon. Generally, the stent comprises an expandable substantially rigid tube, sheet, wire or spring, but preferably a cylindrical mesh sleeve. See Palmaz, U.S. Pat. No. 4,733,665, incorporated herein by reference. Alternatively, the stent may be a self-expanding sleeve, preferably from nitinol. In this case, the stent catheter does not require an inflatable balloon. Instead the stent is compressed over the catheter and a sheath or outer catheter is directed over the stent to hold it in the compressed condition until time of deployment. The guidewire has a filter assembly attached at or near its distal end, which includes an expansion frame which is adapted to open from a contracted condition to an enlarged condition. Filter material, typically a fine mesh, is attached to the expansion frame to filter undesirable embolic material from blood. The guidewire with the expansion frame in its contracted condition is provided through a sheath or cannula, or preferably is included directly in the stent catheter. The catheter typically has a second lumen extending from its proximal region to its distal end into which the guidewire is introduced. The filter assembly on the distal end of the guidewire is then available to be extended beyond the distal end of the catheter for use during stent delivery. The device is typically used to introduce a stent into a stenosed or occluded region of a patient, preferably within the carotid arteries. The catheter is introduced percutaneously into a blood vessel and is directed through the blood vessel to the desired region. If the filter device is provided in a separate sheath, the sheath is percutaneously inserted into the blood vessel downstream of the region being treated, and is fixed in position. The filter assembly is introduced into the blood vessel, and the expansion frame is opened to its enlarged condition, extending the filter mesh substantially across the blood vessel until the filter mesh substantially engages the walls of the vessel. The catheter is inserted through the region being treated until the stent is centered across the plaque deposited on the walls of the blood vessel. Fluid, preferably saline solution, is introduced through the inflation lumen, inflating the balloon, and expanding the stent radially outwardly to engage the plaque. The stent pushes the plaque away from the region, dilating the vessel. The balloon is deflated, and the catheter is withdrawn from the region and out of the patient. The stent remains substantially permanently in place, opening the vessel and trapping the plaque beneath the stent. When the stenosed region is opened, embolic material may break loose from the wall of the vessel, but will encounter the filter mesh and be captured therein, rather than traveling on to lodge itself elsewhere in the body. After the stent is delivered, the expansion frame is closed, containing any material captured in the filter mesh. The filter assembly is withdrawn back into the sheath or the catheter itself, which is then removed from the body. If a self-expanding stent is used, the stent catheter with the compressed stent thereon is inserted into a sheath, which restrains the stent in a compressed condition. The catheter is introduced into the patient's blood vessel and directed to the target region. Once the stent is localized across the stenosed region and the filter assembly is in position, the sheath is drawn proximally in relation to the catheter. This exposes the stent, which expands to engage the wall of the blood vessel, opening the lumen. The filter assembly is then closed and the catheter withdrawn from the patient. The filter assembly has a number of preferred forms. For example, the expansion frame may comprise a plurality of struts or arms attached to and extending distally from the distal end of the guidewire. The struts are connected to each other at each end and have an intermediate region which is biased to expand radially. Filter mesh is attached typically between the intermediate region and the distal ends of the struts, thereby defining a substantially hemispherical or conical shaped filter assembly. To allow the filter assembly to be inserted into the lumen of the sheath, the intermediate region of the expansion frame is compressed. When the filter assembly is ready to be introduced into a blood vessel, the guidewire is pushed distally. The expansion frame exits the lumen, and the struts automatically open radially. This expands the filter mesh to substantially traverse the vessel. After the stent is delivered, the guidewire is pulled proximally to withdraw the filter assembly. The struts contact the wall of the filter lumen, forcing them to compress, closing the frame as the filter assembly is pulled into the sheath. In another embodiment, the expansion frame includes a plurality of struts attached to the distal end of the sheath. The struts extend distally from the sheath and attach to the distal end of the guidewire which is exposed beyond the sheath. At an intermediate region, the struts are notched or otherwise biased to fold out radially. Filter mesh is attached to the struts between the intermediate region and the distal end of the guidewire. The filter assembly is directed into position in the blood vessel, either exposed on the end of the sheath or preferably within a second sheath which is withdrawn partially to expose the filter assembly. With the sheath fixed, the guidewire is pulled proximally. This compresses the struts, causing them to bend or buckle at the intermediate region and move radially outwardly, expanding the filter mesh across the blood vessel. After use, the guidewire is pushed distally, pulling the struts back down and closing the filter mesh. In an alternative to this embodiment, the struts attached to the distal end of the sheath and to the distal end of the guidewire are biased to expand radially at an intermediate region. The filter mesh is attached to the struts between the intermediate region and the distal end of the guidewire. Prior to introduction into a patient, the guidewire is rotated torsionally in relation to the sheath, twisting the struts axially around the guidewire and compressing the filter mesh. Once in position in the blood vessel, the guidewire is rotated in the opposite direction, unwinding the struts. The struts expand radially, opening the filter mesh. After use, the guidewire is rotated once again, twisting the struts and closing the filter mesh for removal. In yet another embodiment, the filter assembly comprises a plurality of substantially cylindrical compressible sponge-like devices attached in series to the guidewire. The devices have an uncompressed diameter substantially the same as the open regions of the blood vessel. They are sufficiently porous to allow blood to pass freely through them but to entrap undesirable substantially larger particles, such as loose embolic material. The devices are compressed into the lumen of the sheath prior to use. Once in position, they are introduced into the blood vessel by pushing the guidewire distally. The devices enter the vessel and expand to their uncompressed size, substantially engaging the walls of the blood vessel. After use, the guidewire is pulled proximally, forcing the devices against the distal end of the sheath and compressing them back into the lumen. In a second embodiment, a stent catheter and filter assembly are also provided. Unlike the previous embodiments, the filter assembly is not primarily mechanically operated, but is instead, generally fluid operated. Typically, the stent catheter includes a second balloon on or near the distal end of the catheter. A second inflation lumen extends through the catheter from the proximal region of the catheter to the balloon. The balloon is part of the expansion frame or alternatively merely activates the expansion frame, opening the filter assembly to the enlarged condition for use and closing it after being used. In one form, the balloon has an annular shape. Filter mesh is attached around the perimeter of the balloon, creating a conical or hemispherical-shaped filter assembly. A flexible lumen extends between the balloon and the inflation lumen within the catheter. Optionally, retaining wires are connected symmetrically between the balloon and the catheter, thereby holding the balloon substantially in a desired relationship to the catheter. When deflated, the balloon substantially engages the periphery of the catheter, holding the filter mesh closed and allowing the catheter to be directed to the desired location. Once the catheter is in position, the balloon is inflated. The balloon expands radially until it engages the walls of the blood vessel, the filter mesh thereby substantially traversing the vessel. After use, the balloon is deflated until it once again engages the perimeter of the catheter, thereby trapping any embolic material between the filter mesh and the outer wall of the catheter. Alternatively, the balloon of this embodiment may be provided on the catheter proximal of the stent for retrograde use. In this case, the filter mesh is extended between the balloon and the outer surface of the catheter, instead of having a closed end. In a third embodiment of the present invention, a method is provided in which a stent catheter is used to prevent the detachment of mobile aortic deposits within the ascending aorta, the aortic arch or the carotid arteries, either with or without an expandable filter assembly. A stent catheter, as previously described, is provided having an inflatable balloon and a stent thereon, or alternatively a self-expanding stent and a retaining sheath. The catheter is percutaneously introduced into a blood vessel and is directed to a region having mobile aortic plaque deposits, preferably a portion of the ascending aorta or the aortic arch. The stent is positioned across the desired region, and the balloon is inflated. This expands the stent to engage the plaque deposits and the walls of the blood vessel, thereby trapping the plaque deposits. The balloon is deflated, and the catheter is removed from the blood vessel. Alternatively if a self-expanding stent is used, the sheath is partially withdrawn proximally, and the stent is exposed, allowing it to expand. The stent substantially retains its expanded configuration, thereby containing the plaque beneath the stent and preventing the plaque from subsequently detaching from the region and traveling downstream. Optionally, a filter device similar to those already described may be introduced at a location downstream of the treated region. The filter device may be provided in a sheath which is inserted percutaneously into the blood vessel. Preferably, however, a filter device is attached to the stent catheter at a location proximal to the stent. Instead of attaching the filter assembly to a guidewire, it is connected directly to the outer surface of the catheter proximal to the stent. A sheath or cannula is typically provided over the catheter to cover the filter assembly. Once the catheter is in position within the vessel, the sheath is withdrawn proximally, the filter assembly is exposed and is expanded to its enlarged condition. In a preferred form, the expansion frame includes biased struts similar to the those described above, such that when the filter assembly is exposed, the struts automatically expand radially, and filter mesh attached to the struts is opened. After the stent is deployed, the sheath is moved proximally, covering the expansion frame and compressing the struts back into the contracted condition. The catheter and sheath are then withdrawn from the patient. Thus, an object of the present invention is to provide an apparatus and method for substantially preventing mobile aortic plaque deposited within the ascending aorta, the aortic arch, or the carotid arteries from detaching and traveling to undesired regions of the body. Another object is to provide an apparatus and method for treating stenosed or occluded regions within the carotid arteries. An additional object is to provide an apparatus and method for introducing a stent to treat a stenosed or occluded region of the carotid arteries which substantially captures any embolic material released during the procedure. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the invention, and to show how it may be carried into effect, reference will be made, by way of example, to the accompanying drawings, in which: FIG. 1 is a longitudinal view of an embodiment being inserted into a blood vessel, namely a stent catheter in a stenosed region and a filter device downstream of the region. FIG. 2 is a longitudinal view of another embodiment, showing the filter device included in the stent catheter. FIG. 3 is a longitudinal view of an embodiment of the filter assembly in its enlarged condition within a blood vessel. FIGS. 4A , 4 B and 4 C show a longitudinal view of an embodiment of the filter assembly in a contracted condition, a partially expanded condition, and an enlarged condition respectively within a blood vessel. FIGS. 5A , 5 B and 5 C show a longitudinal view of another embodiment of the filter device in a contracted condition, a partially opened condition, and an enlarged condition across a blood vessel respectively. FIGS. 6A and 6B are longitudinal views, showing the orientation of the filter mesh in an antegrade approach to a stenosed region and in a retrograde approach respectively. FIG. 7 is a longitudinal view of another embodiment of the filter assembly. FIGS. 8A and 8B are longitudinal views of another embodiment of the filter assembly, showing the filter mesh without gripping hairs and with gripping hairs respectively. FIG. 9 is a longitudinal view of another embodiment of the filter assembly including sponge-like devices. FIG. 10 is a longitudinal view of another embodiment, namely a filter assembly attached to the outer surface of a stent catheter. FIGS. 11A and 11B show a filter assembly attached to the outer surface of a stent catheter, with a sheath retaining the filter assembly in the contracted condition, and with the filter assembly in the enlarged condition respectively. FIGS. 12A and 12B are longitudinal views of another embodiment including an inflatable filter assembly, shown in a contracted condition and an enlarged condition respectively. FIG. 13 is a longitudinal view of an inflatable filter assembly attached to the catheter proximal of the stent shown in an enlarged condition. FIG. 14 depicts a longitudinal view of a stent deployment device having a distal filter disposed within a carotid artery. FIGS. 15 15 A, 15 B, 15 C and 15 D show detailed longitudinal and cross-sectional views of a guidewire filter in accordance with the present invention. FIGS. 16 , 16 A, 16 B, 16 C and 16 D show longitudinal and cross-sectional views of an eggbeater filter in accordance with the present invention. FIGS. 17 and 17A show longitudinal views of a filter scroll in accordance with the present invention. FIGS. 18 , 18 A, and 18 B show longitudinal views of a filter catheter in accordance with the present invention. FIG. 19 shows an alternate construction for an eggbeater filter as disclosed herein. FIG. 20 shows a longitudinal view of an imaging guidewire having an eggbeater filter and restraining sheath. FIG. 21 shows human aortic anatomy and depicts several routes for deployment of an aortic filter upstream of the carotid arteries. FIG. 22 depicts a longitudinal view of a generalized filter guidewire. FIGS. 23 and 23A depict longitudinal views of a compressible, expansible sheath disposed over a guidewire in accordance with the present disclosure. DETAILED DESCRIPTION Turning to FIG. 1 , a first embodiment of the present invention is shown, namely a stent catheter 10 and a filter device 30 . The stent catheter 10 typically includes a catheter body 12 , an inflatable balloon 16 , and a stent 20 . The catheter body 12 typically comprises a substantially flexible member having a proximal end (not shown) and a distal end 14 . The balloon is mounted on a region at or near the distal end 14 of the catheter body 12 . An inflation lumen 18 extends longitudinally from a region at or near the proximal end of the catheter body 12 to the balloon 16 . The stent 20 is introduced over the balloon 16 , typically by manually compressing it onto the balloon 16 . The stent 20 may comprise a tube, sheet, wire, mesh or spring, although preferably, it is a substantially cylindrical wire mesh sleeve, that is substantially rigid, yet expandable when subjected to radial pressure. Many known stent devices are appropriate for use with the present invention, such as those discussed elsewhere in this disclosure. Generally the stent is furnished from materials such as stainless steel or nitinol, with stainless steel being most preferred. Alternatively, a self-expanding stent (not shown) may also be used, such as those disclosed in Regan, U.S. Pat. No. 4,795,458, Harada et al., U.S. Pat. No. 5,037,427, Harada, U.S. Pat. No. 5,089,005, and Mori, U.S. Pat. No. 5,466,242, the disclosures of which are incorporated herein by reference. Such stents are typically provided from nitinol or similar materials which are substantially resilient, yet compressible. When an expandable stent is used, the stent catheter does not generally include an inflatable balloon for the stent. Instead, the stent is compressed directly onto the catheter, and a sheath is placed over the stent to prevent it from expanding until deployed. In addition to the catheter 10 , the present invention typically includes a filter device 30 . The filter device 30 generally comprises an introducer sheath 32 , a guidewire 40 , and an expandable filter assembly 50 , although alternatively the guidewire 40 and the filter assembly 50 may be provided directly on the catheter 10 as will be described below (see FIG. 2 ). The sheath 32 has a proximal end 34 and a distal end 36 , and generally includes a hemostatic seal 38 mounted on its proximal end 34 . The guidewire 40 , typically a flexible, substantially resilient wire, having a distal end 42 and a proximal end 44 , is inserted into the proximal end 34 of the sheath 32 through a lumen 33 . A hub or handle 46 is generally mounted on the proximal end 44 for controlling the guidewire 40 . Generally, attached on or near the distal end 42 of the guidewire 40 is an expandable filter assembly 50 which generally comprises an expansion frame 52 and filter mesh 60 . The expansion frame 52 is generally adapted to open from a contracted condition while it is introduced through the lumen 33 of the sheath 32 to an enlarged condition once it is exposed within a blood vessel 70 , as will be discussed more particularly below. The filter mesh 60 is substantially permanently attached to the expansion frame 52 . The construction of the stent catheter 10 should already be familiar to those skilled in the art. The catheter body 12 is typically made from substantially flexible materials such as polyethylene, nylon, PVC, polyurethane, or silicone, although materials such as polyethylene and PVC are preferred. The balloon 16 for delivering the stent 20 is generally manufactured from a substantially flexible and resilient material, such as polyethylene, polyester, latex, silicone, or more preferably polyethylene and polyester. A variety of balloons for angioplasty or stenting procedures are available which have a range of known inflated lengths and diameters, allowing an appropriate balloon to be chosen specifically for the particular blood vessel being treated. The sheath 32 for the filter device 30 generally comprises a conventional flexible sheath or cannula for introducing catheters or guidewires into the blood stream of a patient. Exemplary materials include polyethylene, nylon, PVC, or polyurethane with polyethylene and pvc being most preferred. The hemostatic seal 38 generally is an annular seal designed to prevent the escape of blood from the vessel through the sheath 32 , and includes materials such as silicone, latex, or urethane, or more preferably silicone. The hemostatic seal 38 is substantially permanently adhered to the proximal end 34 of the sheath 32 using known surgically safe bonding materials. The guidewire 40 is generally manufactured from conventional resilient wire such as stainless steel or nitinol, although stainless steel is preferred, having a conventional hub or handle 46 formed integral with attached to its proximal end 44 . Turning now to FIG. 3 , the filter assembly 50 of the present invention is generally shown extending from the distal end 36 of a sheath or catheter 32 and in an enlarged condition within a blood vessel 70 . The filter assembly 50 includes an expansion frame 52 comprising a plurality of struts, ribs or wires 54 , each strut 54 having a substantially fixed proximal end 56 and a distal end 58 , which may or may not be fixed. The proximal ends 56 are typically connected to the distal end 42 of the guidewire 40 , or alternatively to the outer surface of a distal region (not shown in FIG. 3 ) of the guidewire 40 , typically using conventional bonding methods, such as welding, soldering, or gluing. The distal ends 58 of the struts 54 are connected to the filter mesh 60 , or alternatively to the distal end of the guidewire (not shown). The struts generally comprise substantially resilient materials such as stainless steel or nitinol, with stainless steel being preferred. Generally, the filter mesh 60 comprises a fine mesh having an open region 64 substantially engaging the wall 72 of the blood vessel 70 and a closed region 62 , shown here as the apex of a cone. An appropriate mesh is selected, having a pore size that permits blood to flow freely through the mesh, while capturing therein undesired particles of a targeted size. Appropriate filter materials are disclosed in co-pending applications Barbut et al., U.S. application Ser. No. 08/553,137, filed Nov. 7, 1995, Barbut et al., U.S. application Ser. No. 08/580,223, filed Dec. 28, 1995, Barbut et al., U.S. application Ser. No. 08/584,759, filed Jan. 9, 1996, Barbut et al., U.S. application Ser. No. 08/640,015, filed Apr. 30, 1996, Barbut et al., U.S. application Ser. No. 08/645,762, filed May 14, 1996, and Maahs, U.S. application Ser. No. 08/842,727, filed Apr. 16, 1997. The disclosure of these references and any others cited herein are expressly incorporated herein by reference. An exemplary embodiment of the mesh has a mesh area of 3-8 sq. in., a mesh thickness of 60-200 μm, a thread diameter of 30-100 μm, and a pore size of 60-100 μm. Polyethylene meshes, such as Saati Tech and Tetko, Inc. meshes, provide acceptable filter materials, as they are available in sheet form and can be easily cut and formed into a desired shape. The mesh is formed into a desired filter shape and is sonic welded or adhesive bonded to the struts 54 . The present invention is then typically used to introduce a stent into a stenosed or occluded region of a patient, preferably for treating a region within the carotid arteries. Referring again to FIGS. 1 and 2 , the catheter 10 is first introduced into a blood vessel 70 using known percutaneous procedures, and then is directed through the blood vessel to the stenosed region of the target blood vessel. The catheter 10 is typically introduced in an upstream-to-downstream (antegrade) orientation as shown in FIGS. 1 and 14 , although the catheter may also be introduced in a downstream-to-upstream (retrograde) orientation as will be described below. In a preferred example, the catheter 10 is inserted into a femoral artery and directed using known methods to a carotid artery, as shown in FIG. 14 , or alternatively is introduced through a lower region of a carotid artery and directed downstream to the stenosed location 74 . The sheath 32 is percutaneously introduced into the blood vessel 70 downstream of the stenosed region 74 , and is deployed using conventional methods. The distal end 42 of the guidewire 40 is directed through the lumen 33 of the sheath 32 until the filter assembly 50 is introduced into the blood vessel 70 by pushing distally on the hub 46 on the guidewire 40 . When the distal end 42 of the guidewire 40 enters the blood vessel 70 , the expansion frame 52 is opened to its enlarged condition, extending substantially across the entire cross-section of the vessel 70 . The filter mesh 60 attached to the frame 52 substantially engages the luminal walls 72 of the vessel 70 , thereby capturing any undesirable loose material passing along the blood vessel 70 from the treated region 74 . The catheter 10 is inserted through the stenosed region 74 until the stent 20 is centered across the plaque or embolic material 76 deposited on the walls 72 of the blood vessel 70 . If the region 74 is substantially blocked, it may be necessary to first open the region 74 using a balloon catheter prior to insertion of the stent catheter (not shown in FIG. 3 ), as will be familiar to those skilled in the art. Once the stent 20 is in the desired position, fluid, saline, or radiographic contrast media, but preferably radiographic contrast media, is introduced through the inflation lumen 18 to inflate the balloon 16 . As the balloon 16 expands, the pressure forces the stent 20 radially outwardly to engage the plaque 76 . The plaque 76 is pushed away from the region 74 , opening the vessel 70 . The stent 20 covers the plaque 76 , substantially permanently trapping it between the stent 20 and the wall 72 of the vessel 70 . Once the balloon 16 is fully inflated, the stent 20 provides a cross-section similar to the clear region of the vessel 70 . The balloon 16 is then deflated by withdrawing the fluid out of the inflation lumen 18 and the catheter 12 is withdrawn from the region 74 and out of the patient using conventional methods. The stent 20 remains in place, substantially permanently covering the plaque 76 in the treated region 74 and forming part of the lumen of the vessel 70 . As the stenosed region 74 is being opened, or possibly as the catheter 12 is being introduced through the region 74 , plaque may break loose from the wall 72 of the vessel 70 . Blood flow will carry the material downstream where it will encounter the filter mesh 60 and be captured therein. Once the catheter 12 is removed from the treated region 74 , the expansion frame 52 for the filter mesh 60 is closed to the contracted position, containing any material captured therein. The filter assembly 50 is withdrawn into the lumen 33 of the sheath 32 , and the filter device 30 is removed from the body. In another embodiment, shown in FIG. 2 , the guidewire 40 and the filter assembly 50 are included within the stent catheter 10 , rather than being provided in a separate sheath, thus eliminating the need for a second percutaneous puncture into the patient. As already described, the catheter 12 is provided with an inflatable balloon 16 furnished near its distal end 14 and with a stent 20 compressed over the balloon 16 . In addition to the inflation lumen 18 , a second lumen 19 extends through the catheter 12 from a proximal region (not shown) to its distal end 14 . A guidewire 40 , having a filter assembly 50 on its distal end 42 , is introduced through the lumen 19 until its distal end 42 reaches the distal end 14 of the catheter 12 . As before, the filter assembly 50 comprises an expansion frame 52 and filter mesh 60 , which remain within the lumen 19 of the catheter 12 until deployed. As described above, the stent catheter 10 is percutaneously introduced and is directed through the blood vessels until it reaches the stenosed region 74 and the stent 20 is centered across the plaque 76 . The guidewire 40 is pushed distally, introducing the filter assembly 50 into the blood vessel 70 . The expansion frame 52 is opened to the enlarged condition until the filter mesh 60 engages the walls 72 of the blood vessel 70 . The balloon 16 is then inflated, pushing the stent 20 against the plaque 76 , opening the treated region 74 . As before, the stent 20 substantially permanently engages the plaque 76 and becomes part of the lumen 72 of the vessel 70 . After the balloon 16 is deflated, the expansion frame 52 of the filter assembly 50 is closed to the contracted condition, and the filter assembly 50 is withdrawn into the lumen 19 . The stent catheter 10 is then withdrawn from the patient using conventional procedures. Alternatively, a self-expanding stent may be substituted for the expandable stent described above. Generally, the stent is compressed onto a catheter, and a sheath is introduced over the catheter and stent. The sheath serves to retain the stent in its compressed form until time of deployment. The catheter is percutaneously introduced into a patient and directed to the target location within the vessel. With the stent in position, the catheter is fixed and the sheath is withdrawn proximally. Once exposed within the blood vessel, the stent automatically expands radially, until it substantially engages the walls of the blood vessel, thereby trapping the embolic material and dilating the vessel. The catheter and sheath are then removed from the patient. The filter assembly 50 generally described above has a number of possible configurations. Hereinafter reference is generally made to the filter device described above having a separate sheath, although the same filter assemblies may be incorporated directly into the stent catheter. Turning to FIGS. 4A , 4 B, and 4 C, another embodiment of the filter device 30 is shown, namely a sheath 32 having a guidewire 40 in its lumen 33 and a filter assembly 50 extending from the distal end 36 of sheath 32 . The filter assembly 50 comprises a plurality of struts 54 and filter mesh 60 . The guidewire 40 continues distally through the filter mesh 60 to the closed end region 62 . The proximal ends 56 of the struts 54 are attached to the distal end 36 of the sheath 32 , while the distal ends 58 of the struts 54 are attached to the distal end 42 of the guidewire. In FIG. 4A , showing the contracted condition, the struts 54 are substantially straight and extend distally. At an intermediate region 57 , the open end 64 of the filter mesh 60 is attached to the struts 54 using the methods previously described. The filter mesh 60 may be attached to the struts 54 only at the intermediate region 57 or preferably continuously from the intermediate region 57 to the distal ends 58 . In addition, at the intermediate region 57 , the struts 54 are notched or otherwise designed to buckle or bend outwards when compressed. Between the intermediate region 57 of the struts 54 and the distal end 36 of the sheath 32 , the guidewire 40 includes a locking member 80 , preferably an annular-shaped ring made of stainless steel, fixedly attached thereon. Inside the lumen 33 near the distal end 36 , the sheath 32 has a recessed area 82 adapted to receive the locking member 80 . The guidewire 40 and filter assembly 50 are included in a sheath 32 as previously described, which is introduced into a blood vessel 70 , as shown in FIG. 4A , downstream of the stenosed region (not shown). With the sheath 32 substantially held in position, the guidewire 40 is pulled proximally. This causes the struts 54 to buckle and fold outward at the intermediate region 57 , opening the open end 64 of the filter mesh 60 as shown in FIG. 4 B. As the guidewire 40 is pulled, the locking member 80 enters the lumen 33 , moving proximally until it engages the recessed area 82 , locking the expansion frame in its enlarged condition, as shown in FIG. 4 C. With the expansion frame 52 in its enlarged condition, the open end 64 of the filter mesh 60 substantially engages the walls 72 of the blood vessel 70 . After the stent is delivered (not shown), the expansion frame 52 is closed by pushing the guidewire 40 distally. This pulls the struts 54 back in towards the guidewire 40 , closing the open end 64 of the filter mesh 60 and holding any loose embolic material within the filter assembly 50 . As a further modification of this embodiment, the entire sheath 32 and filter assembly 50 may be provided within an outer sheath or catheter (not shown) to protect the filter assembly 50 during introduction into the vessel. Once the device is in the desired location, the sheath 32 is held in place and the outer sheath is withdrawn proximally, exposing the filter assembly 50 within the blood vessel 70 . After the filter assembly 50 is used and closed, the sheath 32 is pulled proximally until the filter assembly 50 completely enters the outer sheath, which may then be removed. Turning to FIGS. 5A , 5 B and 5 C, another embodiment of the filter assembly 50 is shown. The proximal ends 56 of the plurality of struts 54 are substantially fixed to the distal end 36 of the sheath 32 . The distal ends 58 may terminate at the open end 64 of the filter mesh 60 , although preferably, the struts 54 extend distally through the filter mesh 60 to the closed end region 62 , where they are attached to the distal end 42 of the guidewire 40 . Referring to FIG. 5A , the filter assembly 50 is shown in its contracted condition. The guidewire 40 has been rotated torsionally, causing the struts 54 to helically twist along the longitudinal axis of the guidewire 40 and close the filter mesh 60 . The filter assembly 50 is introduced into a blood vessel 70 as already described, either exposed on the end of the sheath 32 or, preferably, within an outer sheath (not shown) as described above. Once in position, the sheath 32 is fixed, and the guidewire 40 is rotated torsionally in relation to the sheath 32 . As shown in FIG. 5B , the struts 54 , which are biased to move radially towards the wall 72 of the vessel 70 , unwind as the guidewire 40 is rotated, opening the open end 64 of the filter mesh 60 . Once the struts 54 are untwisted, the expansion frame in its enlarged condition causes the open end 64 of the filter mesh 60 to substantially engage the walls 72 of the vessel 70 , as shown in FIG. 5 C. After the stent is delivered (not shown), the guidewire 40 is again rotated, twisting the struts 54 back down until the expansion frame 52 again attains the contracted condition of FIG. 5 A. The sheath 32 and filter assembly 50 are then removed from the blood vessel 70 . Another embodiment of the filter assembly 50 is shown in FIGS. 6A and 6B . The struts 54 at their proximal ends 56 are mounted on or in contact with guidewire 40 , and their distal ends 58 are connected to form the expansion frame 52 , and are biased to expand radially at an intermediate region 57 . The proximal ends 56 are attached to the distal end 42 of the guidewire 40 with the distal ends 58 being extended distally from sheath 32 . Filter mesh 60 is attached to the struts 54 at the intermediate region 57 . If the filter assembly 50 is introduced in an antegrade orientation as previously described, the filter mesh 60 is typically attached from the intermediate region 57 to the distal ends 58 of the struts 54 , as indicated in FIG. 6 A. Alternatively, if introduced in a retrograde orientation, it is preferable to attach the filter mesh 60 between the intermediate region 57 to the proximal ends 56 of the struts 54 , as shown in FIG. 6B , thus directing the interior of the filter mesh upstream to capture any embolic material therein. The filter assembly 50 is provided with the struts 54 compressed radially in a contracted condition in the lumen 33 of the sheath 32 (not shown). The filter assembly 50 is introduced into the blood vessel 70 by directing the guidewire distally. As the expansion frame 52 enters the blood vessel, the struts 54 automatically expand radially into the enlarged condition shown in FIGS. 6A and 6B , thereby substantially engaging the open end 64 of the filter mesh 60 with the walls 72 of the blood vessel 70 . To withdraw the filter assembly 50 from the vessel 70 , the guidewire 40 is simply pulled proximally. The struts 54 contact the distal end 36 of the sheath 32 as they enter the lumen 33 , compressing the expansion frame 52 back into the contracted condition. FIG. 8A presents another embodiment of the filter assembly 50 similar to that just described. The expansion frame 52 comprises a plurality of struts 54 having a filter mesh 60 attached thereon. Rather than substantially straight struts bent at an intermediate region, however, the struts 54 are shown having a radiused shape biased to expand radially when the filter assembly 50 is first introduced into the blood vessel 70 . The filter mesh 60 has a substantially hemispherical shape, in lieu of the conical shape previously shown. Optionally, as shown in FIG. 8B , the filter mesh 60 may include gripping hairs 90 , preferably made from nylon, polyethylene, or polyester, attached around the outside of the open end 64 to substantially minimize undesired movement of the filter mesh 60 . Such gripping hairs 90 may be included in any embodiment presented if additional engagement between the filter mesh 60 and the walls 72 of the vessel 70 is desired. FIG. 7 shows an alternative embodiment of the filter assembly 50 , in which the expansion frame 52 comprises a strut 54 attached to the filter mesh 60 . The open end 64 of the filter mesh 60 is biased to open fully, thereby substantially engaging the walls 72 of the blood vessel 70 . The mesh material itself may provide sufficient bias, or a wire frame (not shown) around the open end 64 may be used to provide the bias to open the filter mesh 60 . The filter mesh 60 is compressed prior to introduction into the sheath 32 . To release the filter assembly 50 into the blood vessel 70 , the guidewire 40 is moved distally. As the filter assembly 50 leaves the lumen 33 of the sheath 32 , the filter mesh 60 opens until the open end 64 substantially engages the walls 72 of the blood vessel 70 . The strut 54 attached to the filter mesh 60 retains the filter mesh 60 and eases withdrawal back into the sheath 32 . For removal, the guidewire 40 is directed proximally. The strut 54 is drawn into the lumen 33 , pulling the filter mesh 60 in after it. In a further alternative embodiment, FIG. 9 shows a filter assembly 50 comprising a plurality of substantially cylindrical, expandable sponge-like devices 92 , having peripheral surfaces 94 which substantially engage the walls 72 of the blood vessel 70 . The devices 92 are fixed to the guidewire 40 which extends centrally through them as shown. The sponge-like devices have sufficient porosity to allow blood to pass freely through them and yet to entrap undesirable substantially larger particles, such as loose embolic material. Exemplary materials appropriate for this purpose include urethane, silicone, cellulose, or polyethylene, with urethane and polyethylene being preferred. In addition, the devices 92 may have varying porosity, decreasing along the longitudinal axis of the guidewire. The upstream region 96 may allow larger particles, such as embolic material, to enter therein, while the downstream region 98 has sufficient density to capture and contain such material. This substantially decreases the likelihood that material will be caught only on the outer surface of the devices, and possibly come loose when the devices is drawn back into the sheath. The devices 92 are compressed into the lumen 33 of the sheath 32 (not shown), defining the contracted condition. They are introduced into the blood vessel 70 by pushing the guidewire 40 distally. The devices 92 enter the vessel 70 and expand substantially into their uncompressed size, engaging the walls 72 of the vessel 70 . After use, the guidewire 40 is pulled proximally, compressing the devices 92 against the distal end 36 of the sheath 32 and directing them back into the lumen 33 . Turning to FIG. 10 , another embodiment of the present invention is shown, that is, a stent catheter 10 having a filter assembly 50 provided directly on its outer surface 13 . The stent catheter 10 includes similar elements and materials to those already described, namely a catheter 12 , an inflatable balloon 16 near the distal end 14 of the catheter 12 , and a stent 20 compressed over the balloon 16 . Instead of providing a filter assembly 50 on a guidewire, however, the filter assembly 50 typically comprises an expansion frame 52 and filter mesh 60 attached directly to the outer surface 13 of the catheter 12 . Preferably, the expansion frame 52 is attached to the catheter 12 in a location proximal of the stent 20 for use in retrograde orientations, although optionally, the expansion frame 52 may be attached distal of the stent 20 and used for antegrade applications. The filter assembly 50 may take many forms similar to those previously described for attachment to a guidewire. In FIG. 10 , the expansion frame 52 includes a plurality of radially biased struts 54 , having proximal ends 56 and distal ends 58 . The proximal ends 56 of the struts 54 are attached to the outer surface 13 of the catheter 12 proximal of the stent 20 , while the distal ends 58 are loose. Filter mesh 60 , similar to that already described, is attached to the struts 54 between the proximal ends 56 and the distal ends 58 , and optionally to the outer surface 13 of the catheter 12 where the proximal ends 56 of the struts 52 are attached. Prior to use, a sheath 132 is generally directed over the catheter 12 . When the sheath engages the struts 54 , it compresses them against the outer surface 13 of the catheter 12 . The catheter 12 and the sheath 132 are then introduced into the patient, and directed to the desired location. Once the stent 20 is in position, the catheter 12 is fixed and the sheath 132 is drawn proximally. As the struts 58 enter the blood vessel 70 , the distal ends 58 move radially, opening the filter mesh 60 . Once the filter assembly 50 is fully exposed within the blood vessel 70 , the distal ends 58 of the struts 54 , and consequently the open end 64 of the filter mesh 60 , substantially engage the walls 72 of the blood vessel 70 . After the stent is deployed, the sheath 132 is pushed distally. As the struts 54 enter the lumen 133 of the sheath 132 , they are compressed back against the outer surface 13 of the catheter 12 , thereby containing any captured material in the filter mesh 60 . The catheter 12 and sheath 132 are then withdrawn from the vessel 70 . Turning to FIGS. 11A and 11B , an alternative embodiment of the expansion frame 50 is shown. The proximal ends 56 of the struts 54 are attached or in contact with the outer surface 13 of the catheter 12 . The struts 54 have a contoured radius biased to direct an intermediate region 57 radially. Filter mesh 60 is attached between the intermediate region 57 and the proximal ends 56 , or between the intermediate region and the distal end (not shown). FIG. 11A shows the filter assembly 50 in its contracted condition, with a sheath 132 covering it. The sheath 132 compresses the struts 54 against the outer surface 13 of the catheter 12 , allowing the device to be safely introduced into the patient. Once in position, the sheath 132 is pulled proximally as shown in FIG. 11 B. As the distal end 136 of the sheath 132 passes proximal of the filter assembly 50 , the struts 54 move radially, causing the intermediate region 57 of the struts 54 and the open end of the filter mesh 60 to substantially engage the walls 72 of the blood vessel 70 . After use, the sheath 132 is directed distally, forcing the struts 54 back against the catheter 12 and containing any material captured within the filter mesh 60 . In another embodiment of the present invention, shown in FIGS. 12A and 12B , a stent catheter 10 , similar to those previously described, is provided with a fluid operated filter assembly 50 attached on or near the distal end 14 of the catheter 12 . The catheter 12 includes a first inflation lumen 18 for the stent balloon 16 , and a second inflation lumen 19 for inflating an expansion frame 52 for the filter assembly 50 . The expansion frame 52 generally comprises an inflatable balloon 102 , preferably having a substantially annular shape. The balloon 102 generally comprises a flexible, substantially resilient material, such as silicone, latex, or urethane, but with urethane being preferred. The second inflation lumen 19 extends to a region at or near to the distal end 14 of the catheter 12 , and then communicates with the outer surface 13 , or extends completely to the distal end 14 . A conduit 104 extends between the balloon 102 and the inflation lumen 19 . The conduit 104 may comprise a substantially flexible tube of material similar to the balloon 102 , or alternatively it may be a substantially rigid tube of materials such as polyethylene. Optionally, struts or wires 106 are attached between the balloon 102 and the catheter 12 to retain the balloon 12 in a desired orientation. Filter mesh 60 , similar to that previously described, is attached to the balloon 102 . Turning more particularly to FIG. 12A , the filter assembly 50 is shown in its contracted condition. The balloon 102 is adapted such that in its deflated condition it substantially engages the outer surface 13 of the catheter 12 . This retains the filter mesh 60 against the catheter 12 , allowing the catheter 12 to be introduced to the desired location within the patient's blood vessel 70 . The catheter 12 is percutaneously introduced into the patient and the stent 20 is positioned within the occluded region 74 . Fluid, such as saline solution, is introduced into the lumen 19 , inflating the balloon 102 . As it inflates, the balloon 102 expands radially and moves away from the outer surface 13 of the catheter 12 . As shown in FIG. 12B , once the balloon 102 is fully inflated to its enlarged condition, it substantially engages the walls 72 of the blood vessel 70 and opens the filter mesh 60 . Once the stent 20 is delivered and the stent balloon 16 is deflated, fluid is drawn back out through the inflation lumen 19 , deflating the balloon 102 . Once deflated, the balloon 102 once again engages the outer surface 13 of the catheter 12 , closing the filter mesh 60 and containing any embolic material captured therein. The catheter 12 is then withdrawn from the patient. Alternatively, the filter assembly 50 just described may be mounted in a location proximal to the stent 20 as shown in FIGS. 13A and 13B . The open end 64 of the filter mesh 60 is attached to the balloon 102 , while the closed end 62 is attached to the outer surface 13 of the catheter 12 , thereby defining a space for capturing embolic material. In the contracted condition shown in FIG. 13A , the balloon 102 substantially engages the outer surface 13 of the catheter 12 , thereby allowing the catheter 10 to be introduced or withdrawn from a blood vessel 70 . Once the stent 20 is in position across a stenosed region 74 , the balloon 102 is inflated, moving it away from the catheter 12 , until it achieves its enlarged condition, shown in FIG. 13B , whereupon it substantially engages the walls 72 of the blood vessel 70 . A detailed longitudinal view of a filter guidewire is shown in FIG. 15 . Guidewire 40 comprises inner elongate member 207 surrounded by a second elongate member 201 , about which is wrapped wire 211 in a helical arrangement. Guidewire 40 includes enlarged segment 202 , 208 which houses a series of radially biased struts 203 . Helical wires 211 separate at cross-section 205 to expose the eggbeater filter contained within segment 202 . Guidewire 40 includes a floppy atraumatic tip 204 which is designed to navigate through narrow, restricted vessel lesions. The eggbeater filter is deployed by advancing distally elongate member 201 so that wire housing 211 separates at position 205 as depicted in FIG. 15 A. Elongate member 207 may be formed from a longitudinally stretchable material which compresses as the struts 203 expand radially. Alternatively, elongate member 207 may be slideably received within sheath 201 to allow radial expansion of struts 203 upon deployment. The filter guidewire may optionally include a coil spring 206 disposed helically about elongate member 207 in order to cause radial expansion of struts 203 upon deployment. A typical filter guidewire will be constructed so that the guidewire is about 5F throughout segment 208 , 4F throughout segment 209 , and 3F throughout segment 210 . The typical outer diameter in a proximal region will be 0.012-0.035 inches, more preferably 0.016-0.022 inches, more preferably 0.018 inches. In the distal region, a typical outer diameter is 0.020-0.066 inches, more preferably 0.028-0.036 inches, more preferably 0.035 inches. Guidewire length will typically be 230-290 cm, more preferably 260 cm for deployment of a balloon catheter. It should be understood that reducing the dimensions of a percutaneous medical instrument to the dimensions of a guidewire as described above is a significant technical hurdle, especially when the guidewire includes a functioning instrument such as an expansible filter as disclosed herein. It should also be understood that the above parameters are set forth only to illustrate typical device dimensions, and should not be considered limiting on the subject matter disclosed herein. In use, a filter guidewire is positioned in a vessel at a region of interest. The filter is deployed to an expanded state, and a medical instrument such as a catheter is advanced over the guidewire to the region of interest. Angioplasty, stent deployment, rotoblader, atherectomy, or imaging by ultrasound or Doppler is then performed at the region of interest. The medical/interventional instrument is then removed from the patient. Finally, the filter is compressed and the guidewire removed from the vessel. A detailed depiction of an eggbeater filter is shown in FIGS. 16 , 16 A, 16 B, and 16 C. With reference to FIG. 16 , the eggbeater filter includes pressure wires 212 , primary wire cage 213 , mesh 52 , and optionally a foam seal 214 which facilitates substantial engagement of the interior lumen of a vessel wall and conforms to topographic irregularities therein. The eggbeater filter is housed within catheter sheath 32 and is deployed when the filter is advanced distally beyond the tip of sheath 32 . This design will accommodate a catheter of size 8F (0.062 inches, 2.7 mm), and for such design, the primary wire cage 213 would be 0.010 inches and pressure wires 212 would be 0.008 inches. These parameters can be varied as known in the art, and therefore should not be viewed as limiting. FIGS. 16A and 16B depict the initial closing sequence at a cross-section through foam seal 214 . FIG. 16C depicts the final closing sequence. FIGS. 17 and 17A depict an alternative filter guidewire which makes use of a filter scroll 215 disposed at the distal end of guidewire 40 . Guidewire 40 is torsionally operated as depicted at 216 in order to close the filter, while reverse operation ( 217 ) opens the filter. The filter scroll may be biased to automatically spring open through action of a helical or other spring, or heat setting. Alternatively, manual, torsional operation opens the filter scroll. In this design, guidewire 40 acts as a mandrel to operate the scroll 215 . An alternative embodiment of a stent deployment blood filtration device is depicted in FIGS. 18 , 18 A, and 18 B. With reference to FIG. 18 , catheter 225 includes housing 220 at its proximal end 221 , and at its distal end catheter 225 carries stent 223 and expandable filter 224 . In one embodiment, expandable filter 224 is a self-expanding filter device optionally disposed about an expansion frame. In another embodiment, filter 224 is manually operable by controls at proximal region 221 for deployment. Similarly, stent 223 can be either a self-expanding stent as discussed above, or a stent which is deployed using a balloon or other radially expanding member. Restraining sheath 222 encloses one or both of filter 224 and stent 223 . In use, distal region 226 of catheter 225 is disposed within a region of interest, and sheath 222 is drawn proximally to first exposed filter 224 and then exposed stent 223 . As such, filter 224 deploys before stent 223 is radially expanded, and therefore filter 224 is operably in place to capture any debris dislodged during stent deployment as depicted in FIG. 18 A. FIG. 18B shows an alternative embodiment which employs eggbeater filter 224 in the distal region. An alternative design for the construction of an eggbeater filter is shown in FIG. 19 . This device includes inner sheath 231 , outer sheath 230 , and a plurality of struts 232 which are connected to outer sheath 230 at a proximal end of each strut, and to inner sheath 231 at a distal end of each strut. Filter expansion is accomplished by moving inner sheath 231 proximal relative to outer sheath 230 , which action causes each strut to buckle outwardly. It will be understood that the struts in an eggbeater filter may be packed densely to accomplish blood filtration without a mesh, or may include a mesh draped over a proximal portion 233 or a distal portion 234 , or both. In another embodiment, a filter guidewire is equipped with a distal imaging device as shown in FIG. 20 . Guidewire 40 includes eggbeater filter 224 and restraining sheath 222 for deployment of filter 224 . The distal end of guidewire 40 is equipped with imaging device 235 which can be any of an ultrasound transducer or a Doppler flow velocity meter, both capable of measuring blood velocity at or near the end of the guidewire. Such a device provides valuable information for assessment of relative blood flow before and after stent deployment. Thus, this device will permit the physician to determine whether the stent has accomplished its purpose or been adequately expanded by measuring and comparing blood flow before and after stent deployment. In use, the distal end of the guidewire is introduced into the patient's vessel with the sheath covering the expandable filter. The distal end of the guidewire is positioned so that the filter is downstream of a region of interest and the sheath and guidewire cross the region of interest. The sheath is slid toward the proximal end of the guidewire and removed from the vessel. The expandable filter is uncovered and deployed within the vessel downstream of the region of interest. A percutaneous medical instrument is advanced over the guidewire to the region of interest and a procedure is performed on a lesion in the region of interest. The percutaneous medical instrument can be any surgical tool such as devices for stent delivery, balloon angioplasty catheters, atherectomy catheters, a rotoblader, an ultrasound imaging catheter, a rapid exchange catheter, an over-the-wire catheter, a laser ablation catheter, an ultrasound ablation catheter, and the like. Embolic material generated during use of any of these devices on the lesion is captured before the expandable filter is removed from the patient's vessel. The percutaneous instrument is then withdrawn from the vessel over the guidewire. A sheath is introduced into the vessel over the guidewire and advanced until the sheath covers the expandable filter. The guidewire and sheath are then removed from the vessel. Human aortic anatomy is depicted in FIG. 21 . During cardiac surgery, bypass cannula 243 is inserted in the ascending aorta and either balloon occlusion or an aortic cross-clamp is installed upstream of the entry point for cannula 243 . The steps in a cardiac procedure are described in Barbut et al., U.S. application Ser. No. 08/842,727, filed Apr. 16, 1997, and the level of debris dislodgment is described in Barbut et al., “Cerebral Emboli Detected During Bypass Surgery Are Associated With Clamp Removal,” Stroke, 25(12):2398-2402 (1994), which is incorporated herein by reference in its entirety. FIG. 21 demonstrates that the decoupling of the filter from the bypass cannula presents several avenues for filter deployment. As discussed in Maahs, U.S. Pat. No. 5,846,260, incorporated herein by reference, a modular filter may be deployed through cannula 243 either upstream 244 or downstream 245 . In accordance with the present disclosure, a filter may be deployed upstream of the innominate artery within the aorta by using a filter guidewire which is inserted at 240 through a femoral artery approach. Alternatively, filter guidewire may be inserted through route 241 by entry into the left subclavian artery or by route 242 by entry through the right subclavian artery, both of which are accessible through the arms. The filter guidewire disclosed herein permits these and any other routes for accessing the ascending aorta and aortic arch for blood filtration. In another embodiment, a generalized filter guidewire is depicted in FIG. 22 . FIG. 23 shows guidewire 40 having sleeve 250 disposed thereabout. Sleeve 250 includes longitudinally slitted region 251 which is designed to radially expand when compressed longitudinally. Thus, when the distal end of sleeve 250 is pulled proximally, the slitted region 251 buckles radially outwardly as shown in FIG. 23A to provide a form of eggbeater filter. The expanded cage thus formed may optionally include mesh 52 draped over a distal portion, a proximal portion, or both. In use, a stent catheter, such as those previously described, is used in a retrograde application, preferably to prevent the detachment of mobile aortic plaque deposits within the ascending aorta, the aortic arch, or the descending aorta. Preferably, the stent catheter is provided with a filter assembly, such as that just described, attached to the catheter proximal of the stent. Alternatively, a stent catheter without any filter device, may also be used. The stent catheter is percutaneously introduced into the patient and directed to the desired region. Preferably, the catheter is inserted into a femoral artery and directed into the aorta, or is introduced into a carotid artery and directed down into the aorta. The stent is centered across the region which includes one or more mobile aortic deposits. If a filter assembly is provided on the catheter, it is expanded to its enlarged condition before the stent is deployed in order to ensure that any material inadvertently dislodged is captured by the filter. Alternatively, a sheath having a guidewire and filter assembly similar to those previously described may be separately percutaneously introduced downstream of the region being treated, and opened to its enlarged condition. The stent balloon is inflated, expanding the stent to engage the deposits. The stent forces the deposits against the wall of the aorta, trapping them. When the balloon is deflated, the stent substantially maintains its inflated cross-section, substantially permanently containing the deposits and forming a portion of the lumen of the vessel. Alternatively, a self-expanding stent may be delivered, using a sheath over the stent catheter as previously described. Once the stent has been deployed, the filter assembly is closed, and the stent catheter is withdrawn using conventional methods. Unlike the earlier embodiments described, this method of entrapping aortic plaque is for a purpose other than to increase luminal diameter. That is, mobile aortic deposits are being substantially permanently contained beneath the stent to protect a patient from the risk of embolization caused by later detachment of plaque. Of particular concern are the ascending aorta and the aortic arch. Loose embolic material in these vessels presents a serious risk of entering the carotid arteries and traveling to the brain, causing serious health problems or possibly even death. Permanently deploying a stent into such regions substantially reduces the likelihood of embolic material subsequently coming loose within a patient, and allows treatment without expensive intrusive surgery to remove the plaque. While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims.

1a

FIELD OF THE INVENTION [0001] The present invention relates to medical devices in general and, in particular, to atherectomy devices for removing occluding material from a patient's vessels. BACKGROUND OF THE INVENTION [0002] A number of vascular diseases, such as arteriosclerosis, are characterized by the buildup of deposits (atheromas) in the intimal layer of a patient's blood vessels. If the atheromas become hardened into calcified atherosclerotic plaque, removal of the deposits can be particularly difficult. Deposits in the vasculature can restrict the flow of blood to vital organs, such as the heart or brain, and can cause angina, hypertension, myocardial infarction, strokes, and the like. [0003] To treat such diseases, many invasive and noninvasive techniques have been developed. For example, cardiac bypass surgery is now a commonly performed procedure whereby an occluded cardiac artery is bypassed with a segment of a healthy blood vessel that is obtained from elsewhere in the body. While this procedure is generally successful, it is traumatic to the patient because the entire chest cavity must be opened to access the site of the occluded vessel. Therefore, the procedure is not often performed on elderly or relatively frail patients. [0004] As an alternative to cardiac bypass surgery, numerous atherectomy devices have been developed for removing such deposits in a less invasive manner. One such device that is particularly suited to removing calcified atherosclerotic plaque is an ablative rotational atherectomy device, such as that disclosed in U.S. Pat. No. 4,990,134 by Auth. Auth teaches using a small burr covered, or partially covered, with an abrasive cutting material, such as diamond grit, to remove the occluding deposit by ablation. A rotational atherectomy device practicing the Auth invention is sold by the assignee of the present invention under the trademark Rotablator™. [0005] To perform the atherectomy procedure, a guide catheter is inserted into the patient, frequently at the femoral artery, and advanced through the patient's vasculature until the distal end of the guide catheter is located near a target occlusion. A guide wire is then inserted through the guide catheter and advanced past the occlusion. An atherectomy device having a flexible drive shaft attached to a small abrasive burr is then advanced through the guide catheter and over the guide wire to the point of the occlusion. The burr is then rotated at high speed and advanced through the occlusion to remove the deposit. The ablative process produces particles that are sufficiently small such that they will not re-embolize in the distal vasculature. As the burr removes the occlusion, a larger lumen is thereby created in the vessel, thereby improving blood flow through the vessel. [0006] It is well recognized that the risk of certain patient complications increases with the size of the guide catheter through which minimally invasive devices are routed. Larger guide catheters require larger access holes in the femoral artery, creating the potential for patient complications, such as the sealing of the puncture site after completion of the procedure. Therefore, physicians generally wish to utilize the smallest possible guide catheter during a procedure. However, the smaller size guide catheters can only accommodate correspondingly smaller sized ablation burrs. Therefore, if a large vessel is to be treated, a larger burr and larger guide catheter must be used to successfully remove all of the occlusion from the patient's vessel. [0007] In addition, existing ablation burrs are rigid, having a fixed diameter, and may require undesirably large forces to traverse larger occlusions. Therefore, currently many procedures are performed using multiple passes through the occlusion with ablation burrs of increasing diameter. While these procedures have proven effective, the use of multiple devices for a single procedure adds both time and cost to the procedure. Expandable rotational ablation burrs have been developed, such as those disclosed in U.S. Pat. No. 6,096,054, which is assigned to the assignee of the present invention. It is sometimes desirable, however, that the ablation burr have a fixed, well-defined maximum operating diameter. Expandable ablation burrs may have a maximum operating diameter that is a function of the rotational speed of the burr, or otherwise not provide sufficient dimensional stability for specific applications. [0008] Given these desired operating characteristics, there is a need for an atherectomy device having a burr with a predictable, well-defined maximum operating diameter that can treat large occlusions without requiring multiple burrs and that can be routed to the occlusion site using a relatively small diameter guide catheter. SUMMARY OF THE INVENTION [0009] The invention disclosed herein is an atherectomy device utilizing a compressible burr, whereby the compressible burr can be advanced to and withdrawn from the site of an occlusion using a guide catheter having a diameter that is smaller than the operational diameter of the burr. Because the compressible burr expands in situ to its operational maximum diameter, a single burr can be used to ablate moderately thick occlusions, eliminating the need to use multiple burrs with graduated diameters. [0010] According to a first embodiment of the invention, the atherectomy device includes an ablation burr attached to a drive shaft with a support member, the burr having at least one foldable, annular abrasive disk attached to the support member, and an abrasive nose member disposed forwardly from the support member, such that the ablation burr can fit within a guide catheter in a folded configuration. [0011] In one aspect of the first embodiment, the foldable, annular disk has a plurality of radial cuts that extend from the edge of the disk part way towards the center. The radial cuts divide the annular disk into a plurality of disk segments that facilitate folding of the disk. [0012] According to a second embodiment of the invention, the compressible burr comprises an elongate support member attachable to the drive shaft and a radially extending panel attached to the support member that extends in a spiral fashion outwardly from the support member. The panel is elastically compressible such that the panel can be elastically urged toward the support member. [0013] In one preferred aspect of the second embodiment the panel includes a decreasing-diameter proximal portion that provides a ramp whereby retraction of the burr into the catheter will urge the panel toward a compressed configuration. [0014] According to a third embodiment of the invention, the compressible burr comprises a hub fixedly attachable to the drive shaft having a plurality of flexible struts attached thereto. A compressible body substantially fills the volume created by the interior of the struts. The struts have an abrasive outer surface. The struts can flex inwardly to elastically compress the compressible body. [0015] In one preferred aspect of the third embodiment, the struts comprise a generally convex back portion that form an increasing diameter portion of the burr and a generally concave forward portion that form a decreasing diameter portion of the burr. [0016] According to a fourth embodiment of the invention, the compressible burr comprises a plurality of plastically deformable wires that are attached to the drive shaft in spaced-apart fashion at a distal end, and a flexible sheath having an ellipsoidal volume that encloses the plurality of wires. A portion of the outer surface of the flexible sheath is coated with abrasive particles, such as diamond particles, to produce an ablative surface. The plurality of wires can be deformed inwardly to decrease the diameter of the burr, and are selected to expand on spin-up of the burr, thereby inflating the sheath to its predetermined ellipsoidal shape, or designed to expand to size when released from a guide catheter, into which it may be withdrawn. [0017] According to a fifth embodiment of the present invention, the compressible burr comprises a nose portion having an ablative leading surface, wherein the nose portion is attached to the drive shaft, and a resilient shell extends proximally from the nose portion. The resilient shell includes a compressible center portion having an abrasive outer surface. In one preferred aspect of the fifth embodiment, the shell includes a back portion that slidably engages the drive shaft such that when the center portion is compressed the back portion can move proximally. In one version of the fifth embodiment, the shell includes a back portion that is attached to the drive shaft, and has an elongate member extending forwardly to the nose portion. The center portion is open in the back and coaxially surrounds the elongate member of the back portion. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: [0019] [0019]FIGS. 1A, 1B and 1 C illustrate a compressible atherectomy burr according to a first embodiment of the present invention; [0020] [0020]FIGS. 2A and 2B illustrate a compressible atherectomy burr according to a second embodiment of the present invention; [0021] [0021]FIGS. 3A, 3B, and 3 C illustrate a compressible atherectomy burr according to a third embodiment of the present invention; [0022] [0022]FIGS. 4A, 4B, 4 C, and 4 D illustrate a compressible atherectomy burr according to a fourth embodiment of the present invention; and [0023] [0023]FIGS. 5A, 5B, 5 C, and 5 D illustrate two compressible atherectomy burrs according to a fifth embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0024] As explained in further detail below, the present invention is an atherectomy device having an ablation burr that can be compressed to a smaller diameter to facilitate insertion and removal of the ablation burr, but will expand to a fixed diameter during the atherectomy procedure. Referring now to the drawings, the compressible atherectomy burr of the present invention will be described. [0025] [0025]FIGS. 1A, 1B, and 1 C illustrate a first embodiment of an atherectomy burr according to the present invention, wherein the burr 100 is attached to the end of a flexible drive shaft 90 that is disposed within a guide catheter 80 . The burr 100 has a nose portion 102 with an abrasive leading surface 104 . The abrasive leading surface 104 may be formed by affixing abrasive particles to the nose portion 102 or by making the nose portion 102 from a hard material, such as stainless steel, and machining or otherwise affecting an abrasive topography onto the surface of a hard material. [0026] At least one annular flexible disk 110 is located behind or proximal to the nose portion 102 . Three flexible disks 110 are shown in the preferred embodiment. The flexible disks 110 are made of polyurethane or other tough, flexible polymer, and have a center hole 112 that is approximately equal in diameter to the diameter of the drive shaft 90 , and the flexible disks 110 slidably engage the drive shaft 90 . A plurality of cylindrical spacers 106 are slidably inserted between the flexible disks 110 , maintaining them in the desired spaced-apart relation. The flexible disks 110 are fixedly connected to the drive shaft 90 such that rotation of the drive shaft 90 will cause the flexible disks 110 to rotate correspondingly. The details of the connection between the flexible disks 110 and the drive shaft 90 are not critical to the present invention, and may be accomplished in a variety of ways. For example, the flexible disks 110 can be welded, brazed or glued to the drive shaft 90 , or attached to the cylindrical spacers 106 , which are then affixed to the drive shaft. Alternatively, the end portion of the drive shaft 90 could be provided with a keyed (noncircular) shape, and the center hole 112 made to match the keyed shape. Other methods of rotationally coupling the flexible disks 110 to the drive shaft 90 are well known in the art, and within the scope of the present invention. [0027] The flexible disks 110 include a forward surface 114 having an abrasive portion 116 that preferably extends generally to the outer edge of the flexible disks 110 . The abrasive portion 116 may be formed, for example, by affixing abrasive particles, such as diamond particles, to selected portions of the forward surface 114 . Diamond particles may be attached to the forward surface 114 with an adhesive or a plating process, for example. In the preferred embodiment, the flexible disks 110 include a plurality of radial slots 118 that extend from the outer edge of the disks 110 part way to the center hole 112 . The radial slots 118 divide the outer portion of the flexible disks 110 into a number of disk segments 120 . The radial slots 118 may optionally terminate with a small hole 122 , the small hole relieving the stress at the end of the slot 118 and decreasing the force required to bend the disk segments 120 . [0028] As seen most clearly in FIG. 1B, the flexible disks 110 are intended to deform, or fold over, to be slidably insertable into the guide catheter 80 . The guide catheter 80 may include an expanded or fluted portion 85 at its distal end to accommodate the burr 100 with the folded flexible disks 110 . The burr 100 can then be inserted to the location of the occlusion that is to be treated using a guide catheter 80 having a diameter that is smaller than the diameter of the unfolded burr 100 . The catheter 80 can then be pulled back (or the drive shaft 90 pushed forward), releasing the burr 100 and permitting the flexible disks 110 to unfold to their full diameter. It will be appreciated that the flexible disks 110 have a well-defined maximum diameter that will not be significantly effected by spinning the drive shaft 90 at high rotation speeds. After the atherectomy procedure is completed, the drive shaft 90 can be pulled back into the distal end of the guide catheter 80 to fold the flexible disks 110 in order to remove the burr 100 from the patient's vasculature. [0029] It may be desirable to coat the back surfaces 115 of the flexible disks 110 and/or an inner surface 83 of the guide catheter 80 with a hydrophilic coating, such as Hydropass™, available from Boston Scientific and described in U.S. Pat. No. 5,702,754. The hydrophilic coating attracts water molecules, thereby making the surfaces slippery, facilitating insertion and removal of the burr 100 into the catheter 80 . In addition, the hydrophilic coating may be beneficial during ablation since less torque may be transferred to a vessel wall if the burr stalls. In addition, the differential cutting ability of the burr may be enhanced due to the increased ability of the burr to slide over soft tissues. [0030] It will be appreciated that in addition to the advantages associated with insertion and removal of the burr 100 , there may be further advantages of the flexible disks 100 during the atherectomy procedure. For example, the abrasive portions 116 are nominally oriented forwardly in the treated vessel, avoiding or minimizing undesirable contact between the abrasive portion 116 and the vessel wall. As the abrasive disks 110 encounter hardened occlusions in the vessel, forward motion of the flexible drive shaft 90 will cause the flexible disks 110 to bend backwardly, rotating the abrasive portions 116 toward the occlusion, thereby naturally enhancing the ablative action at the location of the hardened occlusion. Although this embodiment has been described and illustrated with three flexible disks 110 , it will be appreciated that more or fewer flexible disks 110 may be used to accommodate the needs of a particular application, and would be within the scope of the present invention. It will also be appreciated that the flexible disk 110 could be made without the radial slots 118 , thereby increasing the stiffness of the flexible disk 110 , while still permitting it to deform into a folded condition for insertion and removal. [0031] A second embodiment of a compressible burr according to the present invention is shown in FIGS. 2A and 2B. The burr 200 includes a centrally located cylindrical portion 210 that is fixedly and generally coaxially connected to a drive shaft 90 such that rotation of the drive shaft 90 will cause the burr 200 to rotate. The drive shaft 90 is covered over a substantial portion of its length with a guide catheter 80 , which, in the preferred embodiment, includes a fluted portion 85 . Although other attachment mechanisms are possible, in the preferred embodiment the central cylindrical portion 210 includes a center hole (not shown) through which the drive shaft 90 is inserted and fixedly attached using any suitable adhesive. [0032] A thin panel of flap portion 220 extends radially outward from the central cylindrical portion 210 to form a generally circular cylindrical shell that partially surrounds the center cylindrical portion 210 . The outer edge 224 of the panel portion 220 is disposed radially away from the center cylindrical portion 210 to form an elongate gap 226 between the outer edge 224 and the center cylindrical portion 210 . The panel portion 220 is formed from a semi-rigid material, selected such that the panel portion 220 can be elastically compressed to close the gap 226 , thereby decreasing the diameter of the burr 200 . [0033] The panel portion 220 includes a forward segment 230 that has a constant axial cross section, and a back segment 232 that tapers radially inward. The taper of the back segment 232 provides a ramp such that when the drive shaft 90 is retracted into the catheter 80 , the tapered back segment 232 will slidably engage the lumen of catheter 80 . As the drive shaft 90 is pulled further back into the catheter 80 , the panel portion 220 will elastically compress thereby reducing the diameter of the burr 200 as it is pulled into the catheter 80 , for easier insertion and extraction of the burr 200 . [0034] The forward segment 230 of the panel portion 220 includes one or more abrasive sections 228 on its exterior surface, providing an ablative surface for the atherectomy procedure. The abrasive portion 228 may be formed, for example, by affixing abrasive particles, such as diamond particles, to selected portions of the outer surface. It may be desirable to coat the back segment 232 of the panel portion 220 and/or the inner surface 83 of the fluted portion 85 of the guide catheter 80 with a hydrophilic coating to facilitate the retraction of the burr 200 into the catheter 80 . As will be appreciated, the burr 200 is rotated such that the edge 224 trails the movement of the burr. In the embodiment shown in FIG. 2B, the burr 200 is always rotated clockwise. However, the burr could also be constructed to rotate counterclockwise as desired. [0035] It is contemplated that this second embodiment of a burr 200 might also incorporate features of other atherectomy burrs described herein. For example, a smaller, forwardly facing nose portion, such as the nose portion 102 shown in FIG. 1A, could be added to the front of the burr 200 to produce a guide hole. Moreover, the panel portion 220 could include a tapered forwardmost segment (not shown) similar to the back segment 232 , but facing forwardly, to facilitate engagement of the occlusion. In particular, a tapered forwardmost segment could taper to generally meet the widest portion of a nose portion, to produce a substantially continuous, increasing diameter, ablative surface. Alternatively, the burr could have a forward nose not contiguous with the flap. [0036] A third embodiment of a compressible burr according to the present invention is shown in FIGS. 3A and 3B. The burr 300 includes a rear hub 310 that is fixedly connected to a drive shaft 90 such that rotation of the drive shaft 90 will cause the burr 300 to rotate. The drive shaft 90 is covered over a substantial portion of its length with a guide catheter 80 , that optionally includes a fluted portion at its distal end. [0037] The burr 300 includes a plurality of flexible struts 320 , each strut having a back portion 322 that is fixedly attached to the rear hub 310 , a forward portion 324 that extends forwardly from the back portion 322 , and a folded back portion 326 , that extends backwardly from the distal end 325 of the forward portion 324 . The plurality of flexible struts 320 are equally spaced around the perimeter of the hub 310 , cooperatively defining a volume therebetween. As seen most clearly in FIG. 3C, which shows a side view of an individual strut 320 , the back portion 322 is preferably longitudinally convex and includes a proximally extending tab portion 323 for attachment to the drive shaft 90 . The forward portion 324 is preferably longitudinally concave. The outer surface of the forward portion 324 is coated with diamond particles 327 to provide an abrasive surface. [0038] A compressible body 330 , such as a hollow elastomeric bladder, is provided within the volume defined by the interior of the flexible struts 320 . The flexible struts 320 are preferably attached to the compressible body 330 , such that the compressible body 330 will generally maintain the flexible struts 320 in a spaced-apart configuration, while also permitting longitudinal flexure of the struts 320 . [0039] The burr 300 can be fabricated, for example, by stamping or wire electro-discharge machining, the flexible struts 320 from a suitable metal, then welding the flexible struts 320 at a proximal end 321 to the rear hub 310 . A liquid injection molding process can then be used to create the compressible body 330 from silicone, or some other suitable material. Finally, any particulate abrasive, such as diamond particles can be attached to the forward portion 324 of the flexible struts 320 . [0040] It will be appreciated that the burr 300 can be deformed to a compressed state, as shown in FIG. 3B. The compressed state has a smaller maximum diameter than the relaxed, expanded state (shown in FIG. 3A). For example, a “pull-in” sheath 340 can be provided that slidably fits within the guide of catheter 80 . When the drive shaft 90 is pulled backwardly, the burr 300 will be pulled against the pull-in sheath 340 , such that the back portion 322 of the flexible struts 320 engage the sheath 340 . Pulling the drive shaft 90 further will result in an inward force on the compressible body 330 from the back portions 322 of the struts 320 , thereby permitting the sheath 340 , and burr 300 to be retracted into the guide catheter 80 . It will be appreciated that other means of compressing and retracting the burr 300 are also possible, including the use of a fluted catheter, as discussed above. [0041] A fourth embodiment of a compressible burr according to the present invention is shown in FIGS. 4A, 4B, and 4 C. The burr 400 is fixedly connected to a drive shaft 90 such that rotation of the drive shaft 90 will cause the burr 400 to rotate. FIG. 4A shows a side view of the burr 400 connected to a drive shaft 90 , and FIG. 4B shows a cross-sectional view of the burr 400 , taken along a axial center plane. The drive shaft 90 is covered over a substantial portion of its length with a guide catheter 80 that optionally includes a fluted portion at its distal end. The burr 400 includes a plurality of elongate flexible members or wires 410 (four shown in FIG. 4C), each wire 410 having a distal end 412 that is attached to the drive shaft 90 , and a proximal end 414 extending proximally from the distal end 412 that is also attached to the drive shaft 90 . The wires 410 are preferably equally spaced around the perimeter of the drive shaft 90 , and may attach directly to the drive shaft 90 or attach through an intermediate hub (not shown) that connects to the drive shaft 90 . [0042] A resilient sheath 420 , having a generally football shape or ellipsoidal shape, encloses the wires 410 . The resilient sheath 420 is attached to the drive shaft 90 , and may optionally also be attached to one or more of the wires 410 . The sheath 420 is thin and sufficiently flexible to collapse, or fold in on itself, and strong enough to provide the working surface for the burr 400 . An abrasive coating 430 , such as a coating including diamond particles, is applied to the forward portion of the sheath 420 in the manner described below. The sheath 420 may be attached to the wires 410 , for example, by use of an appropriate adhesive inside the sheath 420 . The burr 400 may be spun while the adhesive is drying, to keep the adhesive at the outer surface for bonding the wires 410 to the sheath 420 . [0043] The plurality of wires 410 provide a support for the sheath 420 , maintaining it in an uncompressed configuration, as shown in FIG. 4A, during the atherectomy procedure. To facilitate insertion and removal of the burr 400 through the vasculature of the patient, the burr 400 can be compressed by bending the wires 410 inwardly, as shown in FIG. 4D. The burr 400 can then be inserted through the guide catheter 80 to the site of the occlusion. The wires 410 are selected to have sufficient flexibility that upon spin-up of the burr for the ablation procedure, the wires 410 are forced outwardly by centrifugal forces, returning the burr 400 to the uncompressed configuration. [0044] Alternatively, the wires 410 may be made from a resilient elastically deformable material formed to maintain the burr in the desired shape (which may or may not be ellipsoidal), the elastically deformable material being able to elastically compress sufficiently to allow the burr 400 to be inserted through the guide catheter 80 , then elastically springing out to the desired shape when it is no longer constrained by the guide catheter 80 . Another alternative is to use a so-called shape memory alloy, such as NiTi, for the wires 410 . A shape memory alloy wire 410 is deformable to allow the burr to be compressed, but has a selectable preferred shape to which it will return (generally upon being heated). [0045] Two variations of a fifth embodiment of a compressible burr according to the present invention are shown in FIGS. 5A and 5C. The burr 500 a, 500 b is rotatably coupled to a drive shaft 90 such that rotation of the drive shaft 90 will cause the burr 500 a, 500 b to rotate. The burrs 500 a, 500 b include nose portions 510 a, 510 b having abrasive leading surfaces 512 a, 512 b that taper in the distal direction. The abrasive leading surface may be formed, for example, by affixing an abrasive material such as diamond particles to the leading surfaces 512 a, 512 b or by machining or otherwise roughing the leading surfaces 512 a, 512 b to create an abrasive topography. A resilient shell 520 a, 520 b is attached to back surfaces 514 a, 514 b of the nose, for example, by use of an adhesive. Each resilient shell 520 a, 520 b is shown most clearly in FIGS. 5B and 5C. A shell 520 a, 520 b is generally axisymmetric, and includes a collapsible center portion 524 a, 524 b that, in its uncollapsed state, has a greater outer diameter than the nose portion 510 a, 510 b. [0046] The shells 520 a, 520 b may be made from any appropriate resilient material. In the preferred embodiment, a polyurethane polymer is used that having a low elasticity, so that the center portion 524 a, 524 b will not stretch when the burr is rotated at high speeds. The center portion 524 a, 524 b is provided with an abrasive outer surface 525 a, 525 b, at least over the forward part of the center portion 524 a, 524 b. The abrasive outer surface may be formed by affixing diamond particles, or other abrasive particles, to the center portion 524 a, 524 b as described below. [0047] In the first variation of the burr 500 a, shown in FIGS. 5A and 5B, the shell 520 a includes a generally cylindrical proximal portion 522 a extending backwardly from the center portion 524 a, that is disposed coaxially around the drive shaft 90 . The proximal portion 522 a is preferably not affixed to the drive shaft 90 , so that it can slide proximally or distally, to facilitate compression of the center portion 524 a. A distal portion 526 a of the shell 520 a extends forwardly from the center portion 524 a and is fixedly attached to the back surface 514 a of the nose portion 510 a. The nose portion 510 a is attached to the drive shaft 90 such that rotation of the drive shaft will cause a corresponding rotation of the nose portion 510 a. The distal portion 526 a may optionally also have an abrasive outer surface. The resilient center portion 524 a can be collapsed into the guide catheter (not shown) for easier insertion and removal of the burr 500 a, and will expand to its uncompressed state as it is released from the guide catheter. [0048] In the second variation of the burr 500 b , shown in FIGS. 5C and 5D, the shell 520 b is formed in two parts. A proximal portion 522 b is made from a hard material such as stainless steel. The proximal portion 522 b includes a generally cylindrical back section 521 b that is fixedly connected to the drive shaft 90 , and a smaller-diameter, elongate forward section 523 b that extends coaxially forward. The nose portion 510 b is attached to the distal end of the elongate forward section 523 b. The nose portion may include an abrasive outer surface, similar to that described above. The resilient center portion 524 b is attached to the back surface 514 b of the nose portion 510 b. The resilient center portion 524 b has a maximum diameter that is greater than the diameter of the nose portion 510 b that can be collapsed into the guide catheter (not shown) for easier insertion and removal of the burr 500 b. [0049] It will appreciated that collapsing these burrs 500 a, 500 b aids in insertion and removal of the burrs into the patient's vasculature by permitting the use of a guide catheter having a smaller diameter than the working diameter of the burrs 500 a, 500 b . Additionally, during the atherectomy procedure, as the burrs are rotated in the proximity of an occlusion, the resilient center portions 524 a, 524 b will flex to accommodate restricted passageways in the patient's vessels that are causes by the occlusion. The resilient center portions 524 a, 524 b and, in particular, the abrasive surfaces 525 a, 525 b will provide a gentle, outward pressure on the occlusion, facilitating the ablative removal of the occlusion during the procedure, and the burrs 500 a, 500 b will expand to the desired, predetermined maximum radius as the occlusion is removed. [0050] In the various embodiments of the preferred embodiment described above, where abrasive particles are to be affixed to a polymeric burr element, any suitable method of affixing the particles may be used. For example, in the preferred embodiments, the abrasive is secured to the polymeric member by creating a thin base layer of silver using vacuum deposition techniques such as are well known in the art. Metalization of polymeric materials is discussed, for example, in U.S. Pat. No. 5,468,562 to Farivar, et al., and in the references cited therein. Once the silver base layer is applied to the polymeric member, a layer of metal such as nickel having a slurry of diamond particles disposed therein can be plated to the base layer using an electro- or electroless-plating method as is done with conventional burrs. [0051] In some instances, it may be desirable to etch or mask a portion of the polymeric member with a patter of dots or other shapes so that the base layer does not completely surround the polymeric member. If the abrasive is only plated to the etched pattern, it may allow the polymeric member to more easily expand, collapse, or otherwise flex, and also enhance the adhesive stability of the abrasive coating. In the preferred embodiments, abrasive dots or pads having a diameter of approximately 0.010 to 0.015 inches are used. [0052] In addition to electroplating, it is believed that other techniques could be used to secure the abrasive to the balloon, such as by using an adhesive or chemically bonding sites on the outer surface of the polymeric balloon to which metal ions such as copper, silver, gold, or nickel may bond. These sites may be bonded to the polymeric member using a high-vacuum plasma system or by incorporating chemicals (such as carbon, silver, etc.) with the polymer prior to fabrication of the polymeric member. Alternatively, it is believed that pulse cathode arc ion deposition could be used to incorporate bonding sites on the surface of the elastomer. [0053] While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the scope of the invention. It is therefore intended that the scope of the invention be determined from the following claims and equivalents thereto.

1a

REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of U.S. Ser. No. 09/877,999, filed Jun. 8, 2001 now U.S. Pat. No. 6,939,564, the contents of which is incorporated herein by reference, in its entirety. FIELD OF THE INVENTION The present invention relates to stimuli responsive amphiphilic polymers forming supramolecular assemblies or micelles in the nanometric size range under favourable conditions. These supramolecular assemblies or micelles can be useful for the oral or parenteral delivery of hydrophobic or cationic pharmaceutical agents. BACKGROUND OF THE INVENTION Amphiphilic block copolymers having optimal hydrophilic and hydrophobic segments self-assemble spontaneously in aqueous environment forming micelles or supramolecular assemblies. These supramolecular assemblies exhibit core-shell architecture wherein the hydrophobic part forms the core and the hydrophilic part forms the corona. Recently, polymeric micelles have been widely used as drug delivery carriers for parenteral administration. Micellar drug delivery carriers have several advantages including biocompatibility, solubilization of hydrophobic drugs in the core, nanometric size ranges which facilitate extravasation of the drug carrier at the site of inflammation, site-specific delivery etc. (see for example Torchilin VP, J Controlled Release, 2001, 73 137–172; Kataoka et al, Adv Drug Deliv Rev, 2001, 47, 113–131; Jones et al, Eur J Pharm Biopharm, 1999, 48, 101–111). A large number of amphiphilic block copolymers, having nonionic and/or charged hydrophobic and hydrophilic segments, that form micelles are reported in the literature. Examples of some widely used block copolymers for parenteral delivery include poly(ethylene oxide)-b-poly(D,L-lactide), poly(ethylene oxide)-b-poly(ε-caprolactone), poly(ethylene oxide)-b-poly(aspartic acid), poly(N-vinyl pyrrolidone)-b-poly(D,L-lactide) etc. U.S. Pat. No. 6,322,805 describes polymeric drug carrier micelles prepared from amphiphilic block copolymer having a hydrophilic poly(alkylene oxide) component and a biodegradable hydrophobic component selected from a group consisting of poly(lactic acid), poly(lactic-co-glycolic acid), poly(ε-caprolactone) and a derivative thereof. These micelles are capable of solubilizing hydrophobic drug in a hydrophilic environment. U.S. Pat. No. 6,338,859 describes polymeric micelle compositions where the hydrophilic component includes poly(N-vinyl-2-pyrrolidone) and the hydrophobic component is selected from a group consisting of polyesters, polyorthoesters, polyanhydride and derivatives thereof. The polyester group can be selected from poly(D,L-lactic acid), poly(glycolic acid), lactide/glycolide copolymers, poly(s-caprolactone) and derivatives thereof. The micelle composition contains a therapeutic agent which can be an antitumor compound, hydrophobic antibiotic, hydrophobic antifungal agent, an immunomodulator, an antiviral drug, or the like. U.S. Pat. No. 6,383,811 describes formation of complexes of polyions such as DNA with polyampholytes i.e. polymers possessing both cationic and anionic moieties, and delivery of the complex into the cell. U.S. Pat. No. 6,210,717 describes a composition composed of mixed polymeric micelles made of amphiphilic polyester-polycation copolymer and an amphiphilic polyester-sugar copolymer for delivery of nucleic acids into targeted host cells. The polyester-polycation forms an electrostatic interaction with polyanionic nucleic acids, and the polyester-sugar copolymer directs the micelle-nucleic acid complex to cells in vivo. U.S. Pat. No. 6,429,200 describes delivery of polynucleotides to cells using cleavable reverse micelles. Other molecules such as polymers, and surfactants containing disulphide linkages can be included into the complex micelles to enhance the delivery. U.S. Pat. No. 5,510,103 describes block copolymers having the hydrophilic and hydrophobic segments forming micelles and entrapping the hydrophobic drugs by physical methods. The hydrophilic segment is preferably poly(ethylene oxide) and hydrophobic segment is preferably poly(ε-benzyl-L-aspartate) while the preferred drug is adriamycin. U.S. Pat. No. 5,955,509 describes use of poly(vinyl-N-heterocycle)-b-poly(alkylene oxide) copolymers in micelle containing pharmaceutical formulations. These copolymers respond to pH changes in the environment and can be used to deliver therapeutic compounds at lower pH values. The micelles of these polymers remain intact at neutral pH, e.g. at physiological pH, while they will release the contents when exposed to a lower pH environment such as in the tumor. U.S. Pat. No. 6,497,895 describes hyperbranched micelles containing a core of mucic acid esters for the encapsulation of hydrophobic molecules. These polymers are useful for the transdermal delivery of the entrapped agent in a controlled manner. U.S. Pat. No. 6,387,406 describes compositions of the poly(oxyethylene)-poly(oxypropylene) block copolymers for oral delivery of biological agents. Nishiyama et al (Pharm Res 2001, 18, 1035–1041; J Controlled Release 2001, 74, 83–94) have described the use of poly(ethylene oxide)-b-poly(α,β-aspartic acid) block copolymers forming micelles by interaction with an antitumor drug, specifically cisplatin. Though the majority of these polymers can be used for oral delivery of bioactive agents, what is presently lacking are amphiphilic polymers capable of forming supramolecular assemblies that respond to an environmental stimuli such as pH change, thereby entrapping the contents in the micelle core at a low pH, such as that prevailing in the stomach, and rapidly releasing the contents at a higher pH, such as that prevailing in the intestine. In our earlier filed U.S. patent application (Ser. No. 09/877,999, Jun. 8, 2001) we describe a series of ionizable diblock copolymers useful for the delivery of bioactive agents. A series of the polymers in this patent application partially fulfills the above requirement. These polymers are different from those disclosed in U.S. Pat. No. 5,955,509 in that they form supramolecular assemblies at low pH, that could be dissociated upon increase in the pH above pKa of the carboxyl group. Another characteristic of these polymers is the presence of nonionizable and reversibly ionizable groups in the hydrophobic segment, where, hydrophobicity can be changed by controlling the ionization. SUMMARY OF THE INVENTION The present invention relates to polymers useful in combination with pharmaceutical compositions containing at least one biologically active agent. More particularly, the invention relates to block copolymers having hydrophilic and hydrophobic segments suitable for, but not limited to, oral drug delivery. More particularly, the hydrophilic segment of the polymers is nonionic and the hydrophobic segment contains at least one reversibly ionizable pendant carboxyl group conferring pH-sensitivity to the polymers. Accordingly, it is a primary objective of the instant invention to provide a copolymer which is composed of a hydrophilic segment made of poly(ethylene oxide) and a hydrophobic segment composed of vinyl monomers containing at least one pendant carboxyl group. More particularly, the vinyl monomers included in the polymer are acrylic acid or methacrylic acid having pendant carboxyl groups and butyl (alkyl)acrylate where the butyl segment can be a linear or branched chain. Thus, the hydrophobic segment is a mixture of non-ionizable butyl (alkyl)acrylate and ionizable (alkyl)acrylic acid which controls the hydrophobicity of the polymer. Another objective of the instant invention is to prepare pharmaceutical compositions from the instantly disclosed polymers by entrapping at least one substance, preferably a biologically active agent, which is illustrated by, albeit not limited to a hydrophobic molecule, a cationic compound or macromolecule such as peptides and proteins bearing cationic residues. The entrapment can be physical (e.g. hydrophobic interaction, electrostatic interaction), or chemical (e.g. covalent linkage) in nature. A further objective of the present invention is to prepare supramolecular assemblies having core-shell structure wherein the core is formed by the hydrophobic segment, which can reversibly dissociate and associate in response to a change in environmental pH because of the pendant carboxyl group. The size of these supramolecular assemblies can be between 5 to 1000 nanometers thereby forming a solution or colloidal dispersion in water. It is to be noted that in the further text terms “micelles” and “supramolecular assemblies” are used interchangeably and essentially mean structures having a size range of between about 5 to 1000 nanometers. Yet another objective of the instant invention is to describe methods of entrapping the hydrophobic agents and cationic molecules in the supramolecular assemblies giving high incorporation efficiencies. A still further objective of the present invention is to use these supramolecular assemblies for delivery of a bioactive agent into the body by, but not limited to, the oral route. Upon oral administration, the hydrophobic molecule trapped in the core of the supramolecular assembly will be protected from the harsh acidic conditions of the stomach and released in the intestine due to dissociation of micelle at high pH. Other objectives and advantages of this invention will become apparent from the following description, inclusive of the experimental working examples, taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings constitute a part of this specification and include exemplary embodiments of the instant invention and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 . demonstrates in vitro release of progesterone from PEO-b-poly(nBA 50 -co-MAA 50 ) supramolecular assemblies as a function of pH; FIG. 2 : demonstrates the effect of pH on intensity of light scattered by solution of PEO-b-poly(nBA 50 -co-MAA 50 ); FIG. 3 . is a plot of plasma concentration versus time of fenofibrate upon oral administration of different formulations to Sprague-Dawley rats. DETAILED DESCRIPTION OF THE INVENTION Abbrevations: nBA-n-butyl acrylate; MAA-methacrylic acid; EA-ethyl acrylate; PEO-poly(ethylene oxide). The present invention describes pharmaceutical compositions composed of block polymers composed of a poly(ethylene oxide) forming the hydrophilic segment and a poly(butyl (alkyl)acrylate-co-(alkyl)acrylic acid) forming the hydrophobic segment; and at least one biologically active agent. The molecular weight of the hydrophilic segment can be in the range of 200 to 80,000 Da, more preferably in the range of 500 to 10,000 Da, still more preferably in the range of 2,000 to 5,000 Da. The hydrophobic segments of the polymers in the present invention are composed of butyl (alkyl)acrylate and (alkyl)acrylic acid, where the alkyl chain is composed of from 0 to about 10 carbon atoms, inclusively, more preferably with 0 or 1 carbon atom. The butyl segment of the butyl (alkyl)acrylate can be a linear or branched chain including without limitation n-butyl and tert-butyl groups. The mole ratio of the butyl (alkyl)acrylate: (alkyl)acrylic acid in the hydrophobic segment is in the range of about 5:95 to 95:5, more preferably in the range of about 30:70 to 70:30. The length of the hydrophobic segment can be in the range of about 200 to 50,000, more preferably in the range of about 500 to 80,000 Da. Amphiphilic block copolymers have a tendency to self-assemble in water forming micelles. Upon micellization, the hydrophobic segment forms a core and the hydrophilic segment forms the corona of the micelles. The core of these micelles can be used as a reservoir of hydrophobic compounds protecting them form the external environment. If the hydrophobic segment of the polymer contains reversibly ionizable moieties, then the hydrophobicity of the segment could be manipulated by controlling the ionization of the moiety. Polymers of the present invention differ from other block copolymers in this aspect. In the polymers of the present invention, the hydrophobic segment is composed of the mixture of two monomers, one of them is butyl (alkyl) acrylate, which confers hydrophobicity to the segment. Butyl (alkyl)acrylate monomer is more preferably butyl acrylate or butyl methacrylate. The other monomer, (alkyl)acrylic acid has a pendant carboxyl group that can be reversibly ionized by changing the environmental pH. Thus, when the environmental pH is below the pKa of the carboxyl group, it will remain mostly in the unionized form and will confer hydrophobicity to the segment. This results in spontaneous aggregation of polymeric chains forming stable supramolecular assemblies or micelles in aqueous environment. However, when environmental pH is increased above pKa of the carboxyl group, its ionization will impart hydrophilicity to the hydrophobic segment. This may result in the dissociation of the micelle. (Alkyl)acrylic acid monomer is more preferably acrylic acid or methacrylic acid. These supramolecular assemblies are in the size range of from about 5 to 1000 nanometers. Hydrophobic drugs are incorporated in the core of such supramolecular assemblies by methods that are known to one of ordinary skill in the art (see for example Lavasanifar et al J Controlled Release 2001, 77,155–60; Kohori et J Controlled Release 2002,78,155–63). Manipulation of the composition of the hydrophobic segment results in variation in the hydrophobicity of the polymer allowing control of the incorporation efficiencies of the hydrophobic drugs. Loadings in the range of 0.1 to 50% w/w more preferably in the range of 1 to 20% w/w of hydrophobic drugs are obtained using different drug loading procedures. Block copolymers of the present invention are used to prepare pharmaceutical compositions containing hydrophobic molecules. Non-limiting examples of the hydrophobic molecules includes hypolipidemic agents such as fenofibrate, anticancer agents such as doxorubicin, paclitaxel, docetaxel, camptothecin, megestrol acetate, teniposide, etoposide, antihypertensive agents such as candesartan cilexetil, non-steroidal anti-inflammatory agents such as indomethacin, celecoxib, antiviral agents such as retinovir, amprenavir, indinavir, efavirenz, immunosuppressive agents such as cyclosporin A, sirolimus, tacrolimus, and similar agents belonging to other therapeutic classes. In an alternative embodiment of the present invention, the poly(butyl (alkyl)acrylate-co-(alkyl)acrylic acid) segment of the polymer will bear a negative charge at a pH above the pKa of carboxyl groups and form complexes with cationic molecules including without limitation polycations, peptides and proteins bearing cationic residues by electrostatic interactions. This will result in the partial or complete charge neutralization of polymer and/or cationic molecule thereby forming supramolecular assemblies or micelles. The cation or polycationic molecule will be entrapped in the core of such supramolecular assemblies. The term “cationic residues” refers to the functional groups imparting positive charge to the molecule such as cationic amino acids e.g. lysine, arginine, histidine or other functional groups such as primary, secondary, tertiary or quaternary amine groups present in the molecule. The complexes of poly(ethylene oxide)-block-poly(n-butyl acrylate-co-methacrylic acid) with poly-l-lysine are prepared in a buffer solution at pH 7.4. Supramolecular assemblies having unimodal size distribution within the size range of about 20 to 50 nm are obtained depending upon the molecular weight of the poly-l-lysine and composition of the polymer. On the other hand, complexes of poly(ethylene oxide)-block-poly(ethyl acrylate-co-methacrylic acid) with poly-l-lysine in pH 7.4 buffer results in formation of aggregates having multimodal size distribution with sizes above about 200 nm. In yet another embodiment of the present invention, block copolymers are used to form stable coordination complexes with biologically active agents illustrated as metallic compounds such as cisplatin, carboplatin above the pKa of the carboxyl groups. The presence of butyl (alkyl)acrylate in the hydrophobic segment plays several crucial roles in forming stable supramolecular assemblies. It confers hydrophobicity to the polymer chain, which is one of the important driving forces in the self-assembly of polymeric chains. It also increases the incorporation of hydrophobic drugs in the supramolecular assemblies. It is well known that carboxylic acid groups form intra- and/or intermolecular hydrogen-bonding complexes with oxygen present in the polyethylene oxide chain (see for example Donini et al, Int J Pharm, 2002, 245, 83–91; Lele et al, J. Controlled Release, 2000, 69, 237–248). This results in the formation of large aggregates or sometimes in precipitation of the complex. This problem could be possible in poly(ethylene oxide)-block-poly(aspartic acid) polymers (Nishiyama et al Pharm Res 2001, 18, 1035–1041; Yokoyama et al J Controlled release 1996, 39, 351–356). It was evident in polymers having the composition poly(ethylene oxide)-block-poly(methacrylic acid) as reported previously (Ranger et al J Polymer Science: part A: Polymer Chemistry, 2001, 39, 3861–3874). One method for overcoming this problem is by incorporating hydrophobic monomers such as ethyl acrylate in the hydrophobic segment, as disclosed in our earlier U.S. patent application (Ser. No. 09/877,999 Jun. 8, 2001). In accordance with the instantly disclosed invention, it was observed that polymers with improved characteristics could be obtained by incorporating butyl (alkyl)acrylate in the hydrophobic segment. One of the major advantages of polymers in accordance with the present invention is the presence of the butyl chain of the butyl (alkyl)acrylate that largely minimizes formation of such hydrogen bonding complexes and can prevent formation of aggregates. This aids in the formation of stable supramolecular assemblies having uniform size range. For example, poly(ethylene oxide)-block-poly(n-butyl acrylate-co-methacrylic acid) with 50:50 mole ratio of n-butyl acrylate:methacrylic acid having molecular weight of about 5300 Da forms micelles of 30 nm at pH 5.0 while poly(ethylene oxide)-block-poly(ethyl acrylate-co-methacrylic acid) with 50:50 mole ratio of ethyl acrylate: methacrylic acid having molecular weight of about 5100 Da forms micelles of 120 nm at pH 5.0, which are possibly aggregates of several micelles. An oral route is the most preferred route of administration for a pharmaceutically active agent. For oral delivery, the compositions can be used in the form of tablets, capsules, powders, lozenges, solutions, suspensions, syrups, elixirs, and the like. The pharmaceutical compositions of the present invention are administered orally. The pharmaceutical compositions of the present invention can also be administered by a number of other routes, including without limitation, rectally, vaginally, topically, by pulmonary route, parenterally, including but not limited to intravenous, intra-arterial, intramuscular, intraperitoneal or subcutaneous route. The polymers in the present invention can be modified to attach targeting ligands such as lectin, antibodies or fragments of antibodies, peptides, vitamins or sugar molecules. EXAMPLES In all further text, figures appearing as subscript in the polymer composition indicate the mole ratio of that monomer present in the hydrophobic segment of the polymer. Example 1 In Vitro Release of 3 H-progesterone from PEO-b-poly(nBA 50 -co-MAA 50 ) Supramolecular Assemblies at Different pH: Progesterone was used as a model hydrophobic drug to evaluate the effect of pH on drug release from supramolecular assemblies. 3 H-progesterone was loaded in the supramolecular assemblies of PEO-b-poly(nBA 50 -co-MAA 50 ) of molecular weight 5300 Da by film casting method. Briefly, 10 mg polymer, 1 mg progesterone and 1 μCi 3 H-progesterone were dissolved in a mixture of dichloromethane, ethanol and water in a scintillation vial. The solvents were evaporated under reduced pressure to cast a film of polymer and drug on the glass surface. The film was hydrated with water to obtain the supramolecular assemblies, this solution was filtered through 2 μm filter to remove precipitated drug. For in vitro release study, the solution of progesterone loaded supramolecular assemblies was filled in a dialysis bag (6000–8000 Da molecular weight cut off) and the bag was put in a beaker containing 200 mL of simulated gastric fluid, pH 1.2 maintained at 37° C. The release medium was magnetically stirred. After 2 hours, the pH of medium was adjusted to 7.2 by addition of sodium hydroxide and potassium dihydrogen phosphate. During the entire release experiment, 1 mL samples of release medium were withdrawn periodically to measure the radioactivity of 3 H-progesterone. As a control, the release of 3 H-progesterone from supramolecular assemblies was also measured at pH 1.2, pH 7.2 and at pH 1.2 in absence of polymer. The results of the release experiment are shown in FIG. 1 . As shown in FIG. 1 , the progesterone is released rapidly in the absence of polymer at pH 1.2, suggesting that the dialysis bag does not form a barrier for the drug release. Further, the progesterone release from PEO-b-poly(nBA 50 -co-MAA 50 ) supramolecular assemblies is very rapid at pH 7.2, while slow at pH 1.2. On the other hand, when the pH of the release medium is changed from 1.2 to 7.2 after 2 hours, the release rate increases significantly. This is evidentiary of pH dependent dissociation of supramolecular assemblies. At pH 1.2, the polymer exists in the form of supramolecular assemblies due to unionized carboxyl groups and the drug is released slowly from the core of supramolecular assemblies. However, when the pH is increased to 7.2, the carboxyl groups become ionized resulting in the dissociation of supramolecular assemblies and the drug is released rapidly. To support this data, pH dependent aggregation behavior of PEO-b-poly(nBA 50 -co-MAA 50 ) was studied using dynamic light scattering. Polymer solutions (0.5 mg/mL) were prepared in citrate phosphate universal buffer and the pH was adjusted between about 2.2–7.0. The intensity of scattered light from these solutions at different pH was measured at 25° C. and 90° angle and was plotted as a function of pH. The results are shown in FIG. 2 . From FIG. 2 , it is evident that the scattered light intensity is negligible at pH above ˜5.5 while when the pH is decreased below 5.5, the intensity increases significantly suggesting association of polymeric chains. This indicates that below pH 5.5 the polymer is present in the form of supramolecular assemblies. The size of these supramolecular assemblies is in the range of 30–100 nm depending upon the environmental pH. Example 2 Bioavailability Studies of Fenofibrate Entrapped in Supramolecular Assemblies upon Oral Administration to Rats Fenofibrate (FNB) was used as a model poorly water-soluble hydrophobic drug to evaluate the effect of drug incorporation in supramolecular assemblies on the bioavailability upon oral administration to rats. In a series of experiments, FNB incorporation was studied in different PEO-b-poly(EA-co-MAA) and PEO-b-poly(nBA 50 -co-MAA 50 ) polymers by emulsion and film casting methods. The FNB loading was higher in PEO-b-poly(nBA 50 -co-MAA 50 ) polymers. Therefore these polymers were used to evaluate relative bioavailability of FNB loaded supramolecular assemblies in Sprague-Dawley rats. The study was conducted on 3 fenofibrate formulations, namely FNB supramolecular assemblies, FNB standard formulation and resuspended FNB. FNB loaded supramolecular assemblies were prepared from PEO-b-poly(nBA 50 -co-MAA 50 ) of about molecular weight 5300 Da by film casting method. Size of the supramolecular assemblies was in the range of about 100–300 nm. FNB standard formulation was prepared by suspending the powder from Lipidil Macro® (Fournier) capsule in 0.5% w/v carboxymethyl cellulose sodium (CMC Na) solution to obtain uniform suspension. FNB powder (Sigma) was also suspended in 0.5% w/v CMC Na solution to prepare resuspended FNB formulation which acts as a negative control. Rats were divided into 3 groups of 6 animals each. The rats were fasted overnight and fed with standard diet throughout the study. Each formulation was administered orally at a dose of 7.5 mg/kg to 6 rats from a group. Blood was removed periodically from each rat, plasma was separated and stored at −80° C. till further use. FNB content from the plasma was determined and plotted against time, the results of which are shown in FIG. 3 . The results show that FNB incorporated in supramolecular assemblies results in highest peak plasma level, ie. 10.9 μg/mL compared to 8.4 μg/mL for standard formulation. Also, t max was achieved rapidly by FNB loaded supramolecular assemblies compared to standard formulation. Overall, the relative bioavailability of FNB was enhanced by 19% upon entrapment in supramolecular assemblies compared to standard FNB formulation, and the bioavailability enhancement was 133% compared to resuspended FNB powder. This enhancement in relative bioavailability is possibly due to release of drug from supramolecular assemblies in the nanoscopic size range, which increases the rate of dissolution of drug. Example 3 Formation of Polyion Complex Micelles of PEO-b-P(nBA 50 -co-MAA 50 ) with poly-l-lysin Poly-l-lysine (PLL) of molecular weight 16,100 was used as a model cationic compound for formation of polyion micelles with PEO-b-P(EA 50 -co-MAA 50 ) and PEO-b-P(nBA 50 -co-MAA 50 ) copolymers with molecular weights of 5100 and 5700 Da, respectively. Polymer: PLL (−/+) charge ratios (mole: mole) of 1:1 and 2:1 were used for complex formation. Stock solutions of polymer and PLL (molecular weight 16,100) having concentration of 2.5 mg/mL were prepared in phosphate buffer (pH 7.4) and mixed at room temperature to obtain 1 mg/mL final polymer concentration. The solution was filtered through 0.2 μm filter and size measurements were performed at 25° C. using dynamic light scattering (DLS). The results are shown in Table 1. TABLE 1 Size of different polymer: PLL polyion micelles Charge Diameter % ratio (nm) Popu- Polydispersity Polymer (mol/mol) mean ± SD lation Mean ± SD PEO-b-P(EA 50 - 1:1 1049 ± 170   65 0.571 ± 0.199 co-MAA 50 ) 35 ± 3.2 35 PEO-b-P(EA 50 - 2:1 220 ± 5.1  100 0.448 ± 0.024 co-MAA 50 ) PEO-b-P(nBA 50 - 1:1   31 ± .028 100 0.058 ± 0.012 co-MAA 50 ) PEO-b-P(nBA 50 - 2:1  32 ± 0.2 100  0.11 ± 0.019 co-MAA 50 ) The results of Table 1 show that complexation of PLL with PEO-b-P(EA 50 -co-MAA 50 ) at different charge ratios results in formation of relatively large aggregates which could be attributed to the hydrogen bonding between poly(ethylene oxide) chain and carboxyl groups. In contrast, the complexation of PLL with PEO-b-P(nBA 50 -co-MAA 50 ) at similar ratios results in formation of micelles having unimodal size distribution and low polydispersity indices. Similar complexes are obtained with PLL of different molecular weights. Example 4 Complexation of PEO-b-P(nBA 50 -co-MAA 50 ) with Verapamil Hydrochloride Verapamil hydrochloride was used as a model cationic drug. Solutions of PEO-b-P(nBA 50 -co-MAA 50 ) and verapamil hydrochloride in universal buffer were mixed to obtain final polymer concentration of 0.5 mg/mL and verapamil hydrochloride concentration of 0.8 mg/mL. The solution pH was adjusted to 6.1 and size was measured using DLS. Polyion complex micelles of 38±10.3 nm were obtained. All patents and publications mentioned in this 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. It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement of parts herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and drawings. 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 compounds, compositions, biologically related compounds, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. 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 appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

1a

FIELD OF THE INVENTION The present invention relates to surgical instruments, e.g., instruments for applying surgical fasteners or staples to body tissue, and more particularly relates to visual indicators for such devices. BACKGROUND OF THE RELATED ART Surgical fastening or stapling devices have been used in the medical industry for several years. Many of these instruments require approximation of various components during use. When applying surgical fasteners to bodily tissue, for example, various structures of the instrument must be within a predetermined distance in order for the device to properly function. In performing some surgical procedures, the surgeon may have difficulty in seeing the necessary components to determine when proper approximation has been achieved. Additionally, even when a surgeon can view the various components being approximated, proper gaps and/or distances may be so minute or precise, that even a trained eye may have difficulty in determining if proper approximation and/or alignment has been achieved. There currently exist instruments which have color coded elements to inform the user of proper gaps between the components. However, these elements are typically formed in windows in the instruments and require the surgeon to take a close look to obtain the desired information. Additionally, in laparoscopic surgery, the surgeon typically views the operation in a video screen, e.g., a TV monitor positioned remote from the surgical site. If the indicator is positioned on a handle portion of the instrument, the surgeon would need to look away from the video screen to view the indicator. If the indicator is positioned on the distal end of the instrument, then the indicator must be configured and colored so that it is readily viewable in the video screen, taking into account that the positioning of the instrument relative to the viewing scope may be less than optimum for viewing the indicator and that the illumination inside the body cavity may be limited. Aside from surgical instrumentation that require approximation of various components during use, other surgical instruments are used in surgical procedures whereby such instruments assume multiple positions and orientations during the surgical procedure. For example, graspers, dissectors, scissors and the like assume open and closed configurations in response to actions by the surgeon. Other devices, e.g., electrocautery devices, lasers and the like, supply energy to the surgical site. When using such instrumentation, it is necessary that the surgeon appreciate the status of the instrument, e.g., open/closed, energized/non-energized, etc., to properly utilize the instrument and perform the surgical procedure. Therefore, there is a need for improved indicators for surgical instruments which would provide appropriate information to the surgeon in a convenient and efficacious manner. For example, it is desirable for surgical instrumentation to include indicators that would inform surgeons that an event has occurred and/or provide information to the user that the instrument is properly aligned and/or approximated to perform a specific function. SUMMARY OF THE INVENTION The present invention provides novel visual indication means in association with one or more surgical instruments. Each surgical instrument can include a housing, a first member extending from the housing and a second member positioned in spaced relation relative to the first member, wherein at least one of the members is movable relative to the other. Means are positioned in the apparatus for visually, audibly or tactilely indicating movement of the one member to a predetermined position relative to the other member. The novel indicator means of the present invention includes a power source connected to the indicator means. In one embodiment, the indicator means includes a voltage source, i.e., a battery, a visual indicator which is responsive to electrical current, i.e., a light emitting diode ("LED"), and means for transporting electrical current from the voltage source to the visual indicator. Contacts within the instrument are positioned such that an electrical circuit is open, i.e., the visual indicator is inactive, in one position and closed, i.e., the visual indicator is activated, in another position. In another embodiment of the invention, visual indication means are provided which generate a visual indication at a location remote from the surgical instrument to which the visual indication relates. For example, in laparoscopic or endoscopic surgery, surgical instrumentation is utilized such that the surgery may be performed in a minimally invasive manner. In such procedures, the surgeon typically views the movements and actions of the surgical instrumentation on a video monitor positioned in the operating room, the image being delivered to the monitor by cooperating equipment which includes a rigid or flexible endoscope/laparoscope, a light source delivered to the operative site, a camera adapter associated with the endoscope/laparoscope and appropriate transmission cables and the like. According to the present invention, surgical instrumentation to be utilized in the laparoscopic/endoscopic procedure are provided with visual indication means which sense the relative position or condition of the instrument and, through transmission cables and the like, transfer data concerning the position/condition of the instrument to the video monitor. The data is preferably displayed in the form of an icon, symbol or like means, e.g., changes in color, form or position of data displayed on the monitor, which readily communicates to the surgeon relevant information concerning the position/condition of the subject surgical instrumentation. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing features of the present invention will become more readily apparent and may be understood by referring to the following detailed description of illustrative embodiments of the invention, taken in conjunction with the accompanying drawings, in which: FIG. 1 illustrates a perspective view of a surgical fastening instrument for applying linear rows of fasteners including one embodiment of the indicator mechanism of the present invention; FIG. 2 illustrates a side cross-sectional plan view of a surgical fastening instrument of FIG. 1 in an open and at rest condition; FIG. 3 illustrates the device of FIG. 2 in which the jaw mechanism is partially closed, and the indicator mechanism remains inactivated; FIG. 4 illustrates the device of FIG. 2 in which the jaw mechanism is fully closed and the indicator mechanism is activated; FIG. 5 illustrates the device of FIG. 2 in which the jaw mechanism is fully closed and the trigger mechanism of the device has been actuated so that the fasteners have been driven from the cartridge; FIGS. 5A and 5B illustrate a partial enlarged view of the handle end of the device showing the release mechanism for respectively engaging and for disengaging the retaining means; FIG. 6 illustrates a perspective view of a surgical fastening instrument for applying a circular array of fasteners including one embodiment of an indicator device of the present invention; FIG. 7 illustrates a plan view of the cam member incorporated in the apparatus of FIG. 6; FIG. 8 illustrates an alternative embodiment of the cam member; FIG. 9 illustrates a cross-sectional view of the instrument of FIG. 6 in which a cam member having a dual pitch helical groove is shown corresponding to the position where the anvil member is located away from the staple pusher member and the indicator device remains inactivated; FIG. 10 illustrates a cross-sectional view of the instrument of FIG. 6 in which the cam member is shown in a position corresponding to the anvil member being positioned adjacent to the staple pusher member and the indicator device is activated; and FIGS. 11 and 11A are schematic illustrations of an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in specific detail to the drawings, in which like reference numerals identify similar or identical elements throughout the several views, FIG. 1 shows a surgical fastening instrument 10 which employs an adjustable closure mechanism and the visual indicator device 100 of the present invention. Fastening instrument 10 is provided with a stationary hand grip or hand rest 12 and an actuating handle 14. An elongated body portion 16 is provided which terminates in a distal jaw mechanism 18 which includes an anvil jaw 20 and a cartridge jaw 22. A fastener cartridge (not shown) is positioned within cartridge jaw 22 for driving staples or fasteners through tissue against an anvil surface positioned on anvil jaw 20. Alternatively, the cartridge can contain the fastener portions of two part fasteners which are driven into retainers positioned on the anvil jaw. At the handle end of instrument 10 is provided a push button 26 for operating an advancement mechanism 28, whose function will be described below. An external portion 101 of the visual indicator device includes housing 103 and visual indicator 102. As seen in FIG. 2, push button 26 and advancing mechanism 28 extend outwardly from the proximal end of the instrument 10. A releasable retaining mechanism 32 is slidably engaged to the stationary rod member 36 and is coupled to slider mechanism 40 so that as slider mechanism 40 is urged forwardly into housing 30, retaining mechanism 32 is slidably retained along stationary rod member 36. Advancing mechanism 28 comprises slider mechanism 40 and release rod member 38, such that release rod member 38 and slider mechanism 40 are secured to push button 26. Thrusting push button 26 towards housing 30 slides release rod 38 and slider mechanism 40 into the housing to move the retaining mechanism 32 along rod 36. Slider mechanism 40 extends to linkage structure 42 to activate the linkage structure 42 and urge jaw mechanism 18 distally. Linkage structure 42 moves movable rod 34, as well as fastener driver 56, cartridge frame 44, alignment pin advancement means 24, and cartridge 54 all in a distal direction to selectively position movable cartridge jaw 22 and stationary anvil jaw 20. A more detailed description of the individual mechanisms of the adjustable closure component is described in commonly assigned pending U.S. application Ser. No. 07/779,505 filed Oct, 18, 1991, which is incorporated herein by reference. Turning to the light indicator mechanism 100 of the present invention, with reference to FIG. 2, an electrical circuit is disposed within the surgical instrument. Electrical contact 109 is fixedly positioned on slider mechanism 40. Visual indicator 102 is in the form of an LED and is disposed in housing 103. While visual indicator 102 is preferably an LED, other devices which emit a detectable response to an electrical current are considered to be within the scope of the invention, i.e., incandescent lamps, liquid crystal displays (LCD's), audible indicators, tactile indicators and light/temperature responsive materials. The electrical circuit includes wires 105, 106 and 107. Wire 105 electrically connects indicator 102 to a voltage source 104, such as a battery, wire 106 connects the voltage source 104 to contact 109, and wire 107 connects indicator 102 to contact 108. Clearly, alternatively, a single wire or any number of wires can be used to electrically connect these components. Illumination of indicator 102 is accomplished by closing the circuit which is achieved by bringing contact 109 into abutment with contact 108 as described hereinbelow. Optionally, a current limiter, i.e., a resistor, may be disposed within the electrical circuit. Current limiter 110 is shown on wire 106. Referring now to FIGS. 2 through 5, the operation of the surgical fastener apparatus 10 having the visual indicator 100 of the present invention will now be described. Tissue is first inserted between cartridge jaw 22 and anvil jaw 20 when the instrument is in the position shown in FIG. 2. In this position, contacts 108 and 109 are spaced apart so that the circuit is not complete and indicator 102 is inactive. After tissue which is to be surgically repaired is positioned between cartridge jaw 22 and anvil jaw 20, push button 26 is pushed in the direction of arrow A as seen in FIG. 3 which moves slider mechanism 40 and release rod 38 into housing 30. Retaining mechanism 32 is slid distally along stationary rod 36, and camming surface 90 of slider mechanism 40 engages stationary post 88b to deploy linkage structure 42. As linkage structure 42 is deployed, movable rod 34 is urged forwardly along with cartridge frame 44, thus urging driving pin 50 along frame track 52. Distal movement of slider mechanism 40 carries contact 109 distally toward contact 108. The force of biasing spring 46 is overcome as push button 26 is urged in the direction of arrow A. As driving pin 50 moves in track 52, driving link 48 is moved to the position shown in FIG. 3, which urges alignment pin advancement means 24 to the position shown at the jaw mechanism 18. In this position, alignment pin 62 protrudes from cartridge 54 and aligns with the alignment hole in anvil jaw 20 as cartridge 54 moves in the direction of arrow A'. As linkage structure 42 is deployed and movable rod 34 and cartridge frame 44 move distally, fastener driver 56 also moves distally and coupling arm 58 slides along bearing surface 61. When push button 26 is fully actuated, linkage structure 42 is fully deployed as shown in FIG. 4, and retaining mechanism 32 frictionally engages stationary rod 36 to maintain instrument 10 in the position shown in FIG. 4. At this time, cartridge 54 has moved into position in the direction of arrow A' so that alignment pin 62 is positioned in the alignment hole in anvil jaw 20. Alignment pin advancement means 24 moves slightly proximally so that alignment pin 62 does not protrude beyond anvil jaw 20, and driving link 48 assumes the position shown in FIG. 4. Driving pin 50 has reached the end of track 52. In the position shown in FIG. 4, actuating arm 58 has slid off bearing surface 61 and into notch 60 of fastener driver 56 so that the device as shown in FIG. 4 is ready to be fired. In this position, contacts 108 and 109 are in abutment as slider mechanism 40 has traveled further distally, thereby completing the circuit and allowing electrical current to flow from voltage source 104 to indicator 102. The indicator 102 therefore becomes lit to inform the user that the cartridge jaw is spaced a desired distance from the anvil jaw, i.e., in the proper firing range. It should be noted that the length of one or both of the electrical contacts can be modified to accommodate a range of proper firing distances. For example, if it is desired to increase the range of firing distances which cartridge 54 can be spaced from anvil jaw 20, the length (measured longitudinally) of one of the electrical contacts can be increased so that an increased number of points of contact, e.g., positions of slider 40, will complete the circuit to thereby light indicator 102. Once in the position of FIG. 4, actuating handle 14 is moved in the direction of arrow B (FIG. 5) to fire the fasteners 66. As actuating handle 14 is moved in the direction of arrow B against the force of biasing spring 64, coupling arm 58, having been engaged in notch 60, moves in the direction of arrow C to move fastener driver 56 distally in the direction of arrow D. Fastener driver 56 drives fasteners 66 from cartridge 54 through the tissue (not shown) and into the anvil surface of anvil jaw 20. Upon completion of firing, actuating handle 14 is released and returns to the position shown in FIG. 4. To remove instrument 10 from the surgical site, it is necessary to release the jaw mechanism 18 to return to the position shown in FIG. 2. This is accomplished by pivoting push button 26 in the direction of arrow E, as best seen in FIGS. 5A and 5B, so that beveled surface 27 contacts the housing 30. As push button 26 is pivoted in the direction of arrow E, release rod 38 travels in the direction of arrow F so that contact surface 78 of release rod 38 pivots release lever 74 as shown, which engages contact face 73 to move clamp member 68 to an upright position and perpendicular in relation to stationary rod 36. This releases the frictional engagement of clamp member 68 so that stationary rod 36 and the entire retaining mechanism 32 is moved along stationary rod 36 in the direction of arrow G due to the force of biasing spring 80. The entire mechanism, including the linkage structure 42, jaw mechanism 18, and retaining mechanism 32 is returned to the position shown in FIG. 2. The electrical contacts 109 are likewise returned to their original position of FIG. 2, thereby breaking the circuit to turn off the light indicator 102. It should be noted that the adjustable closure mechanism described herein, can be used in other instruments to close the distance between the movable jaw member and stationary jaw member at the stapling or fastening end of the instrument or between two movable jaw members. That is the jaw mechanism may be of the type, wherein one jaw moves toward and away from the other; however, the present invention is also applicable for use with devices of alternative types, i.e., where both jaws move toward and away from each other. The surgical instrument may be of the type which applies metal staples or two part fasteners of the bioabsorbable type. The indicator device of the present invention can be used with these instruments as well. The surgical stapling or fastening instrument employing the adjustable closure mechanism is a device which may be operated with one hand to effect the closure motion of the jaw members of the instrument followed by activation of the trigger mechanism to fire the staples or fasteners into the tissue. The complex rotational or pivoting arrangement of the prior art devices is eliminated, resulting in a lightweight and easy to handle instrument which is inexpensive to manufacture and easy to assemble. While contacts 108 and 109 of the present invention have been shown in the handle portion of the instrument, it is within scope of the invention that the contacts may be disposed at other positions on or within the device which permits the circuit to be completed when the cartridge jaw is spaced a desired distance from the anvil jaw. For example, contact 108 may be disposed towards the distal end of the instrument and contact 109 can be secured to a movable portion of the instrument disposed at the distal portion as well. For example, contact 109 can be positioned on movable rod 34. FIGS. 6-10 show an indicator device of the present invention utilized with a surgical stapling apparatus 111 for performing circular anastomosis. Apparatus 111 includes a handle assembly 112 having at least one pivotable actuating handle member 114, advancing means 116 and visual indicator mechanism 300. Indicator mechanism 300 includes housing 304 which supports indicator device 302. Indicator mechanism 300 functions in a manner similar to indicator 100 described above. Advancing means 116 preferably comprises a rotatable grip member 118 whose function will be described below. Extending from handle assembly 112, there is provided a tubular body portion 120 which may be constructed so as to have a curved shaped along its length. Tubular body portion 120 may also be straight, and in other embodiments may be flexible to bend to any configuration. Body portion 120 terminates in staple pusher member 122 which is associated with two annular array of staples 124. Positioned opposite staple pusher member 122 is an anvil member 126 which is connected to apparatus 111 by shaft 128. Anvil member 126 and staple pusher member 122 are disclosed in commonly assigned U.S. Pat. No. 5,119,983, issued Jun. 9, 1992, which is incorporated herein by reference. While the preferred embodiment of the present invention utilizes a staple pusher member having an annular array of staples positioned on the tubular body portion, and having the anvil member positioned opposite the staple pusher member for movement towards and away from the staple pusher member, it is contemplated that the anvil member may be positioned on the tubular body portion and the staple pusher member and array of staples be positioned opposite the anvil member for movement towards and away from the anvil member. Such a construction is to be considered within the scope of the present invention. As seen in FIGS. 7, 9 and 10, the adjustable closure mechanism includes a cam member 180 positioned within rotatable bushing 190 and rotatable sleeve member 192. Cam member 180 is provided with a helical groove 182 having a dual pitch. The first pitch 184 is greater than the second pitch 186, so that first pitch 184 provides for coarse adjustment or a large approximation of the anvil member 126 towards staple pusher member 122, while second pitch 186 provides for fine adjustment or incremental movement of the anvil member 126 towards staple pusher member 122. In an alternative and preferred embodiment, cam 400 (FIG. 8) includes helical groove 402 having three stages of helical pitch. Stage "A" has a greater pitch than stage "B" which has a greater pitch than stage "C". As pin 196 travels along helical groove 402 (described below), longitudinal travel per revolution of the cam will vary with each stage. Cam member 180 is secured to inner rod 136 by any suitable means to ensure that movement of cam member 138 operatively advances and retracts inner rod member 136, such as by pin 181. A rotation pin 196 is provided which is operably secured to rotatable sleeve 192, so that upon rotation of grip member 118, helical groove 182 begins to ride over pin member 196 at first pitch 184. Cam member 180 begins to slide rearwardly in bore 194, thus drawing inner rod member 136 and flexible member 134 in a proximal direction. As cam member 180 reaches a point where rotation pin 196 is at the end of first pitch 184, anvil member 126 is positioned adjacent staple pusher member 122. Further rotation of grip member 118, as seen in FIG. 10, causes second pitch 186 to ride over pin 196 to provide for fine adjustment of the distance between anvil member 126 and staple pusher member 122. Turning to the visual indicator mechanism 300, with reference to FIGS. 9 and 10, the device includes voltage source 306, visual indicator 302, contact 310 and contact 308. Contact 308 is positioned on flexible member 134 and contact member 310 is positioned in inner tube 133. Wire position 314 electrically connects indicator 302 to voltage source 306, wire 312 connects voltage source 306 to contact 308, and wire 316 connects contact 310 to indicator 302. Clearly, alternatively, a single wire or any number of wires can be used to electrically connect these components. With reference to FIG. 10, after grip member 118 has been turned a sufficient amount, as described above, contact 308, carried by member 134 is brought into abutment with contact 310. When touching, contacts 308 and 310 complete the circuit and electrical current flows from voltage source 306 to indicator 302, thereby lighting the indicator to provide visual indication that a proper gap between anvil 126 and staples 124 has been achieved. In this embodiment, contact 310 extends in the longitudinal direction to provide for a range of contact points with contact 308. At any point where contact 308 is touching contact 310, indicator 302 will be activated and the user will be informed of adequate spacing between the anvil and stapler. Over approximation (i.e., bringing the anvil assembly too close to the staples), could result in contact 308 passing by contact 310 to a position proximal of contact 310, i.e., out of abutment so that the circuit is not closed. Therefore, indicator 300 could not only function to inform the user when the instrument has been sufficiently approximated, but can also function to inform the user when the instrument has been over approximated and the tissue potentially overclamped. While indicator 300 is shown disposed in a central portion of the instrument, it is within the scope of the invention to place the indicator at any position viewable by the surgeon or staff. Preferably, the indicator is placed in a proximal portion of the instrument, i.e., in grip member 118. In operation, the instrument is positioned within a tubular organ in the body of the patient and the ends of the organ to be joined are positioned in the gap between the staple pusher member 122 and the anvil member 126 so that the anvil member 126 is fully extended. As is conventional, the ends of the organ may be secured over the anvil and the staple pusher member by a purse string suture prior to approximation of the anvil member in relation to the staple pusher member. In this position contacts 308 and 310 are spaced apart. In order to approximate anvil member 126 towards staple pusher member 122, grip member 118 is rotated so that helical groove 182 rides over pin member 196 causing cam member 180 to begin to move proximally. As cam member 180 moves proximally, inner rod member 136 moves proximally bringing flexible member 134 and anvil member 126 with it. This moves contact 308 proximally toward contact 310. Further movement of rod member 136 draws the anvil member 126 into position adjacent staple pusher member 122 and locates the ends of the tissue between these two members. In this position, the contacts are in abutment thereby completing the electrical circuit to activate the indicator. This will indicate to the surgeon in an easily perceivable manner that an appropriate gap between the staple cartridge and anvil has been obtained. Note that due to the pitch of the cam member helical groove, initial rotation of grip member 118 provides for coarse adjustment of the gap or distance between anvil member 126 and staple pusher member 122 and further rotation provides for fine adjustment of the distance between the anvil member 126 and the staple pusher member 122. Once the appropriate gap has been obtained, the surgeon squeezes handles 114 to fire the instrument. Movement of handles 114 towards the body of the instrument causes inner tube 133 to move in a distal direction, thereby causing staples 124 to be ejected from pusher member 122. When ejected, staples 124 pass through tissue disposed between pusher member 122 and anvil 126 and are formed to a tissue securing configuration upon contacting depressions (not shown) in anvil 126. After firing, the instrument is removed in a manner known in the art. Other embodiments of the circular anastomosis insert instrument as well as the detailed operation are disclosed in commonly assigned copending U.S. patent application Ser. No. 07/959,275 filed Oct. 10, 1992, the entire contents of which is incorporated herein by reference. Turning to a further alternative embodiment of the present invention, FIG. 11 shows schematically a system whereby data is transmitted to a video monitor for display, such data relating to the position and/or condition of one or more surgical instruments. As shown in FIG. 11, a laparoscopic surgical procedure is being performed wherein a plurality of trocar sleeves 400 are inserted through a body wall 402 to provide access to a body cavity 404. A laparoscope 406 is inserted through one of the trocar sleeves 400 to provide illumination (light cable 408 is shown leading toward a light source, not pictured) to the surgical site and to obtain an image thereof. A camera adapter 410 is attached at the proximal end of laparoscope 406 and image cable 412 extends therefrom to a control box 414 discussed in more detail below. Image cable inputs to image receiving port 416 on control box 414. Additional surgical instrumentation 418, 420 are inserted through additional trocar sleeves 400 which extend through body wall 402. In FIG. 11, instrument 418 schematically illustrates an endoscopic stapling device, e.g., an Endo GIA* instrument manufactured by the assignee of this application, and instrument 420 schematically illustrates a hand instrument, e.g., an Endo Grasp* device also manufactured by the present assignee. Additional and/or alternative instruments may also be utilized according to the present invention; the illustrated instruments are merely exemplary of surgical instruments which may be utilized according to the present invention. Instruments 418, 420 include adapters 422, 424 associated with their respective handle portions. The adapters electronically communicate with conductive mechanisms (not pictured) of the type described hereinabove with respect to the embodiments of FIGS. 1-10. These mechanisms, which include electrically conductive contact members electrically connected by wires, cables and the like, are associated with the distal elements of the respective instruments, e.g., the anvil 426 and cartridge 428 of the Endo GIA* instrument, the jaws 430, 432 of the Endo Grasp* device, and the like. The mechanisms are adapted to interrupt an electronic circuit when the distal elements are in a first position or condition and to complete the electronic circuit when the distal elements are in a second position or condition. A voltage source for the electronic circuit may be provided in the surgical instrument, e.g., in the form of a battery, or supplied from control box 414 through cables 434 and 436. Control box 414 includes a plurality of jacks 438 which are adapted to receive cables 434, 436 and the like. Control box 414 further includes an outgoing adapter 440 which is adapted to cooperate with a cable 442 for transmitting the laparoscopic image obtained by the laparoscope 406 together with data concerning surgical instruments 418, 420 to video monitor 444. Circuitry within control box 414 is provided for converting the presence of an interrupted circuit, e.g., for the electronics within cable 434 and the mechanism associated with the distal elements of instrument 418, to an icon or symbol for display on video monitor 444. Similarly, the circuitry within control box 414 is adapted to provide a second icon or symbol to video monitor 444 when a completed circuit exists for cable 434 and the associated mechanism. Illustrative icons/symbols 446, 448 are shown on video monitor 444. Icon 446 shows a surgical staple and could be used to communicate to the surgeon that the cartridge 428 and anvil 426 of instrument 418 are properly positioned to form staples in tissue 450. Icon 446 could take another form when the cartridge 428 and 426 are not properly positioned for forming staples, thereby interrupting the circuit, e.g., as shown in FIG. 11A. Icon 448 shows a hand instrument with jaws spread apart, thereby communicating to the surgeon that the jaws 430, 432 of instrument 420 are open. Icon 448 could take another form when jaws 430, 432 are closed, thereby completing the circuit, e.g., as shown in FIG. 11A. As will be readily apparent to one of ordinary skill in the art from the disclosure herein, alternative icons/symbols and/or display indicia may be utilized to communicate to the surgeon the position/condition of surgical instruments utilized according to the present invention, e.g., flashing icons, variable color icons, repositioned icons. Regardless of the type of icon/symbol/indicia selected, the presence of the icons/symbols/indicia on the video monitor permit the surgeon to easily and conveniently ascertain the position/condition of a surgical instrument while viewing the video monitor on which the progress of the surgical procedure is being displayed. The surgeon may also, at his or her election, disconnect the cables from the surgical instruments, thereby disabling the icon/symbol/indicia system, without effecting the operation of the subject surgical instrument. While the invention has been particularly shown and described with reference to the preferred embodiments, it will be understood by those skilled in the art that various modifications and changes in form and detail may be made therein without departing from the scope and spirit of the invention. For example, while the electrical circuit for the above-described instrument have been described in terms of wires, it is understood that any method of transferring electrical current between the voltage source and visual indicator is within the scope of the present invention. In this regard, for example, the electrical path can be defined by conductive materials coated or plated on the handle, body, or movable parts. Other electrically conductive materials include bonded wires and flex cables. The electrical curcuit can be completed in any known mannner, including, for example, the use of magnets, reed switches etc. Furthermore, multiple indicators can be used to indicate different events such as the proper placement of a staple cartridge, the firing of the instrument, etc. Similarly, the transfer of the electronic data from the surgical instrument to the control box may be accomplished by a transmitter associated with the surgical instrument and a receiver associated with the control box, thereby obviating the need for a cable extending therebetween. In a transmitter/receiver embodiment, a voltage source is required within the surgical instrument to power the circuitry and the transmitter. The voltage source is preferably a battery, and most preferably a lithium battery. However, other sources of electrical current are considered to be within the scope of the present invention, i.e., photo voltaic cells, external plugs, and the like. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.

1a

FIELD OF THE INVENTION [0001] The present invention relates to a safe, convenient, easy to attach and remove structure and method for capture and disposal of food and debris dropped by an infant from a seating structure resulting in reduced cleanup for child care givers. BACKGROUND OF THE INVENTION [0002] Children are typically seated in high chairs during mealtime for a variety of reasons. Advantages include mealtime socialization, the ability to interact with the child at seated level, the ability to reach and help the child at mealtime, and the ability to keep the child orderly. One of the main purposes of the use of a high chair is to transition from having the parent feed the child to having the child feed himself/herself. Children are either fed or allowed to feed themselves using a plate of food placed on a table tray or other forward member attached to nearly all high chairs. [0003] Regardless of the extent to which training has occurred, nearly any interaction by the child will result in food, utensil and food container spillage. Food dropped, especially with younger children, typically falls down his or her chest, between or to the side of the child's legs and onto the floor. Consequently, there is a sticky, mushy mess on the floor that must be cleaned. [0004] Some of the devices in use to prevent spillage include a high chair catch attachment as described in U.S. Pat. No. 5,660,432 to Davis as a plurality of additional trays mounted to either side of a high chair to present some probability of retaining debris before it hits the floor. Given that the probability stopping dropped food is proportional to the distance from the high chair as well as the area taken occupied by the trays, the device of Davis has a small probability, about 10% to capture dropped food and items. Further, the trays protruding from the sides of the high chair are easy for adults to trip over and run into resulting in injury. [0005] Another device commonly used to protect the floor area adjacent the high chair is a flexible sheet that is placed directly on the floor and upon which the high chair is placed, little more than a plastic paint drop cloth. This type of device has several disadvantages. Disposability results in significant waste for a large sheet, whereas cleaning the sheet may be as difficult as cleaning food from the floor. This device cannot easily move with the high chair to another location. [0006] Another device is illustrated by U.S. Pat. No. 4848834 to Linski as a specialized structure for used with a chair having no legs and which attaches to the side of a professional sturdily supported restaurant table. Linski provides a drape which extends from underneath the table at a point about 3 feet from the edge and which extends underneath and attaches at the back of the chair attached to the table. This arrangement requires a very sturdy, very heavy table, and takes advantage of the fact that such a specialized table-chair lacks legs and in fact, the chair becomes part of the table. [0007] What is needed is a device which is suitable for commonly commercially available high chairs which will prevent the major portion of food spillage, namely that which falls down the child's chest and legs. The needed device should be easily usable and either washable or disposable. It should be able to work in conjunction with any commercially available high chair. SUMMARY OF THE INVENTION [0008] An easily attachable, washable food, utensil and debris catcher device (hereinafter referred to simply as “catcher”) is easily fitted to all types of commercially available high chairs using a wide variety of attachment structures. The catcher device catches and holds any small items or food spilled in the area of the child's seat and legs. The catcher is designed to be attached to and detached from the high chair quickly and easily, yet can be attached for long periods of time especially where it is employed to catch dry objects such as toys or dry food such as whole peas or cereal. [0009] The catcher may preferably have attachment points to the underside of the high chair tray, or other forward member, as well as to the high chair tray support, including horizontal and vertical parts of the high chair arms. The catcher has a lower structure which may be preferably engaged about a lower structure on the high chair such as a foot rest or other convenient structure the high chair may have. Such lower engagement may be accomplished through a contractible urged edge or some other engagement structure which may or may not be elastically urged. The catcher may have internal structures which range from additional areas of material to seams to stiffening members where it is desired to promote a given shape. [0010] In normal use, the catcher can be detached from both sides of the high chair with two hands and brought downwardly slightly to be removed from underneath the foot support in a way that leaves the bottom most portion of the catcher lower than the front or rear edges. Debris supported by the catcher can be dumped, the catcher can be optionally turned inside out to reveal the contents and presence of any adhered materials. The catcher can then either be replaced onto the high chair, or washed in a conventional washing machine or hand washed. [0011] The catcher is compact and easily rinsed by hand and can be made of such thin material that it is unnecessary to take special procedures to dry it. In most instances it is not necessary to have to wait for it to dry before reattaching it to the highchair. [0012] The catcher of the invention is particularly ideal for children who are between the ages of five and twelve months, especially when they are able to pick up food and place it in their mouths, but haven't started to mischievously throw the food off the sides of the highchair. It is believed that no structure or method can deliver the convenience, safety, and flexibility to cure the spillage of food in a limited structural manner as can the catcher of the present invention. [0013] The catcher may be of a “rip stop nylon” material. It may be water impervious and as lightweight as possible. Such material will enable the catcher constructed to not only be lightweight, but also washable and to dry quickly. The catcher, when stretched flat approximates a half moon in shape. The construction of one embodiment of the catcher may preferably start with a circle of material, and then folded to a two ply semi circle. Elastic may be attached to operate within or adjacent the fold to cause it to contract. Attachment members may be attached at one or more points adjacent the curved periphery for attachment to corresponding attachment areas on the high chair, such as under the tray, adjacent the arms or arm supports. “Darts” or wedge shaped cutouts may occur along the periphery in order to shorten its radial extent, eliminate the need or tendency to form pleats or open gaps in the upper portion when placed against the tray, or generally to assist in forming a convex front profile. The darts may be adjusted in angular width and depth to achieve the convex shape (viewed from the front of the high chair and side profile of the high chair. In terms of the filled-out concave shape of the catcher as it is attached to a high chair, the darts not only eliminate folds which might be formed upon a snug fit to the high chair tray, but also generally help to form the side edges of the concave shape and define the transition from the front of the catcher to its sides. In essence, the darts eliminate the need for thick pleats at the front top of the catcher and enable the front top to be so lightweight as to be almost self supporting, although additional attachment members may be present. The shape of the darts can be modified to give shape effects to the convex front of the catcher once it is in place. [0014] Attachment may be had with interlocking hook-like and felt-like members with one of the set of members, preferably the hook-like members attached to the high chair, and the felt like members attached to the catcher so that upon washing the felt-like members do not catch on other articles being washed. Other attachment mechanisms can be used including hook and eyelet, snap, magnetic, pocket and insert, and more. Where attachment members are complementary, it is a matter of choice as to which of the complementary attachment members is attached to the catcher and which are anchored to the high chair. [0015] Ideally, the catcher may have a minimum of one and preferably two or more pairs of generally symmetrically oppositely located attachment members. In this configuration, the more forward pair of attachment member attach to the high chair food tray at forward most points adjacent the “turn” of the edges of the catcher toward each other to form the front panel. A rearward most pair of attachment members provide rearward most attachment locations holding up the catcher adjacent and high with respect to the location of the legs of the child. These rearward most attachment points help hold a continuation of the rearward extent of the upper part of the catcher, and also provide force and support against the lowermost portion of the catcher which may be elastically urged against the underside of the foot support, if present. [0016] It is preferred that the high chair have at least a partially downwardly and partially forwardly disposed portion of the front seat which may be a foot support or may be a leg guide. In modern high chairs, the seat may be molded to comfortably conform to the child's body and provide a leg guide integral with the seat to gently guide most of the child's body and shield it from any sharp edges or other undesirable surfaces. As a result, most modern high chairs have a leg guide possibly terminating in a forward extending foot support. The ability of the catcher to engage some rearward portion of the leg guide enables the catcher to be used with very little interaction with the child. In essence, the child will only be able to make contact with the catcher by stretching his or her legs to the side near the support points, with the catcher providing a significantly spaced forward enveloping area which many children may not be able to contact. [0017] In the configuration described, the catcher is able to be used with minimum disruption or distraction of the child and very little ability of the child to remove the catcher. Further, the catcher is such that it has a broad front area to support patterns, colors, and promotional logos and names. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The invention, its configuration, construction, and operation will be best further described in the following detailed description, taken in conjunction with the accompanying drawings in which: [0019] FIG. 1 illustrates a plan view looking directly onto an expanse of material which is marked with potential cutting lines for making the expanse of material oval and marked with dart cutting lines; [0020] FIG. 2 is a plan view similar to that seen in FIG. 1 where the expanse of material has been cut to an oval shape and folded over, sewn to form an elastic capture channel and illustrating the dart cutting lines of the upper half of the expanse of material similar to that seen in FIG. 1 ; [0021] FIG. 3 illustrates a plan view approximating a shape which results after removal of dart material and shown where the catch is on a flat surface and in relaxed position; [0022] FIG. 4 is a sectional view taken along line 4 - 4 of FIG. 3 and illustrates the example of a two ply catcher which has a main generally straight edge formed by the folding over of two areas of material and stitched to capture an elastic cord within the fold bounded by the stitch; [0023] FIG. 5 is a view similar to that seen in FIG. 4 and illustrates the example of a single ply catcher which may have an edge folded and stitched to prevent fraying and having an elastic band stitched adjacent the protective fold; [0024] FIG. 6 is a side plan view of a form fitting high chair before attachment of the catcher of the invention, and illustrating the placement of anchoring members in anticipation of attachment of the catcher; [0025] FIG. 7 is a side plan view of a form fitting high chair after attachment of the debris catcher of the invention utilizing the anchoring members seen in FIG. 6 ; and [0026] FIG. 8 is a side sectional view taken from a viewpoint similar to that for FIG. 7 and illustrates the path of travel and collection of food, debris and utensils in the catcher. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0027] The description, construction and operation of the catcher of the invention will be best illustrated by beginning with the construction of the catcher. An expanse of material 21 is provided which may be cut to a circular shape or to an oval shape. Material 21 may preferably be made from polyurethane having a thickness of perhaps 3 mils. An alternative set of cutting lines are seen as cutting line 23 which may preferably form a blended radius for reduction of the effective radius by about 75% and a cutting line 25 which may preferably form a blended radius for reduction of the effective radius by about 83%. [0028] A pair of dart cutting lines 31 and 33 and a pair of dart cutting lines 35 and 37 are shown on the upper half of the expanse of material 21 . A pair of dart cutting lines 41 and 43 and a pair of dart cutting lines 45 and 47 are shown on the lower half of the expanse of material 21 . [0029] The expanse of material can be any size, but may have a maximum radius of about sixty inches down to about forty inches, but for certain models of high chairs the maximum radius may preferably be about forty eight inches. The dart cut lines 31 , 33 , 35 , 37 , 41 , 43 , 45 and 47 can be varied greatly in both length, angle of separation and angle with respect to the effective center of the expanse of material 21 . Further, the darts may be slightly offset. The cut lines 33 & 35 may be farther from each other than the cuts lines 43 and 45 . As will be shown this will provide for some offsets of the resulting darts in the resulting two ply catcher. [0030] Referring to FIG. 2 , the expanse of material 21 of FIG. 1 is shown as having been made more oval by cutting along cutting line 25 , and folded in half. The fold creates a folded edge 51 which has a length equivalent to the maximum diameter seen in FIG. 1 . Adjacent and spaced apart from the folded edge 51 is a continuous stitch 53 which may preferably form an internal channel for supporting a stretched length of elastic (not shown in FIG. 2 . In the alternative, the shape seen in FIG. 2 may be provided a single ply thickness of material with stitching 53 used to stitch a length of stretched elastic near an upper edge (rather than fold 52 ). The use of a folded, two-ply structure seen in FIG. 2 will result in a better exterior finish with resulting darts to have cut edges (for example cutting lines 31 and 33 joined together) sewn on the inside with the cut edges also inside. The opposing set of cutting lines 41 and 43 would similarly be located on the inside, but opposite and slightly offset from a resulting dart formed by the cutting lines 31 and 33 . [0031] Thus, a two-ply material would actually involve forming four darts, two on each side of the material. The two-ply material also allows the formed darts to have stitch lines which are internal for a better finished look, as well as having internally protruding seems offset from each other, which can also contribute to the overall shape of the resulting catcher. [0032] In FIG. 2 , the material between pair of dart cutting lines 31 and 33 and the material between pair of dart cutting lines 35 and 37 are to be removed at removal boundaries 55 . The removal boundaries 55 represent a connection between the pair of dart cutting lines 31 and 33 and pair of dart cutting lines 35 and 37 and are not otherwise specified. The shape of the removal boundary will determine the bulk and outward appearance of the resulting dart when the pairs of dart cutting lines 31 and 33 and 35 and 37 are brought together. The removal boundaries 55 can be straight, or more concave or angled at a greater angle that the dart cutting lines 31 and 33 and 35 and 37 . Forming the removal boundaries 55 as angle concave will reduce the pleat effect. [0033] Referring to FIG. 3 , a plan view is shown in which the pair of dart cutting lines 31 and 33 have been brought together to form a dart 61 having a main seam length portion 63 and tapering into a pleat portion 65 . Likewise, the pair of dart cutting lines 35 and 37 have been brought together to form a dart 71 having a main seam length portion 73 and tapering into a pleat portion 75 . The main seam length portions 63 and 73 represent one way of transitioning from an state where the material is joined from a separation to where the material flows into a sturdy pleat. [0034] The view of FIG. 3 shows the two distal portions of folded edge 51 as being angled with respect to a central portion to form a finished catcher 81 . However, the view of FIG. 3 is merely a representation of the effect of the darts 61 and 71 on the overall shape (as such folded edge 51 is actually made to curve or equivalent). In reality the darts 61 and 71 form a three dimensional shape but for the fact that the expanse of material 21 is left to create undulating folds when laid flat which are not shown because of their unimportance in the flat state and because they randomly occur. [0035] With respect to the darts 61 and 71 , (as well as the two darts which are associated with cutting lines 31 & 33 and 35 & 37 ), the angle of the darts 61 and 71 with regard to the middle of the folded edge 51 , the depth of darts 61 and 71 , and the width of material taken out to form the darts 61 and 71 will control the three dimensionality of the resulting catcher 81 , especially the apparent shape when it is engaged to a high chair (as will be shown). [0036] Also seen in FIG. 3 is a series of fasteners including a first pair of oppositely located fasteners 85 which are located at or near the distal ends of the folded edge 51 , and a second pair of oppositely located fasteners 87 which may be either spaced apart from, adjacent to, or continuous (especially where fasteners 87 and fasteners 85 are hook and loop members),is shown. An optional center fastener 89 is located along a curved edge 91 which is generally opposite, but terminating adjacent to the ends of folded edge 51 . Thus fasteners 87 and 89 can occupy much more length along the curved edge 91 , and that fasteners 85 can occupy much more length along folded edge 51 , especially where a continuous or intermittent engagement fastener is used. It is expected that the catcher 81 will be made with one complementary member of a complementary pair of fasteners already attached to the catcher 81 and that the other of the complementary pair will be provided for adhesive or glued attachment to the specific structures from which the catcher 81 will depend for support. Fasteners 85 , 87 , and 89 may include hook and loop, snap, magnetic, hook and eyelet, tab and slot or simple hook, or any other structure which will enable attachment to child seating, such as high chairs. [0037] As will be shown the periphery which is generally co-extensive with the edge 51 will provide a force component to draw the center of the edge 51 underneath a either a foot support or some other stable anchoring members to enable the catcher to form a stable pocket. As a result, the number and availability of the fasteners along edge 51 can be used to provide further anchoring force, and can help control the catcher 81 more completely if desired. [0038] Conversely, a curved edge 91 will be in a more upwardly directed position and will attach adjacent the tray of a high chair. As will be shown, the material removed which shortens the radius, as well as the material removed for the darts 61 and 71 help take up the excess material to insure a good fit about a high chair tray. [0039] FIG. 3 also illustrates several optional sets of ties 93 which may be utilized where a high chair has an insufficient leg support about which to form a pocket. The ties 93 can assist the generally central area of the edge 51 to be attached to form a debris catching pocket, where a high chair lacks leg supports about which the edge 51 may be elastically looped. [0040] Referring to FIG. 4 , a sectional view taken along line 4 - 4 of FIG. 3 illustrates in the example of a two ply catcher 81 the entrapment of an elastic member 95 , which may be an elastic rope or elastic band. The main generally straight edge 51 Seen in FIGS. 2 and 3 is seen to be part of a capture tube formed by the folding over of two areas of material and stitched with stitch 53 to capture the elastic cord 95 within the fold bounded by the stitch 53 . In the embodiment seen in FIG. 3 , the elastic cord 95 will be stitched at its opposite ends, typically at, along with, or near the first pair of oppositely located fasteners 85 to enable the first pair of oppositely located fasteners 85 to have a more direct connection with the elastic cord 95 . [0041] Referring to FIG. 5 , a view similar to that seen in FIG. 4 illustrates the example of a single ply catcher which may have the edge 51 folded and stitched to prevent fraying, but also having an elastic band 97 continuously stitched adjacent the protective fold of edge 51 . The continuous stitching exposes the elastic band 97 , but as will be seen, one side of the catcher 81 will oppose the underside of a high chair and thus the elastic band 97 will be predominantly hidden during use. [0042] Referring to FIG. 6 , an example of a commercially available high chair 101 is seen. In this particular model, a main back support member 103 is continuous with a rear set of legs 105 . A pair of front leg members 107 are provided, one of which is shown broken away so that it will not obscure the other important members of the high chair 101 . Not all high chairs have the front legs depend from a rear support, but such a design helps to keep front legs away from attachment points and mechanisms the child might be able to reach. [0043] Attached to the main support member 103 are arm rails 109 which support a tray bracket 111 . The arm rails 109 and main support member 103 may have attached or be formed with a form fitting seat 113 which may extend to and be formed integrally with a guided leg and foot support 115 . [0044] The tray bracket 111 typically includes a mechanism for supporting a tray 117 , or other high chair 101 forward and preferably upper member. The tray bracket 111 typically enables the tray to be slid forward or rearward and in some cases removed altogether. The design theme for most modern high chairs is that the child should be completely isolated from the operation mechanism. Thus, the tray 117 extends significantly beyond the bracket 111 . Given the form fitting seat 113 and the fact that the bracket 111 mechanical features are on the outside and underneath the tray, the child is isolated from the mechanism and can contact only smooth surfaces. The views of the form fitting seat 113 and the guided leg and foot support 115 are exterior views of structure which continuously surround the child and do not illustrate the full degree to which the child is isolated from the chair mechanism. [0045] The structures on any given high chair can provide a number of places for attachment of members by which the fasteners 85 and 87 may be attached. It should be noted that the food & debris catcher 81 is very lightweight and it will take very little structural dependence in order to be fully supported. A first anchoring attachment member 121 is seen as supported by the tray bracket 111 . The first anchoring attachment member 121 will typically engage the fastener 85 as the upper and rearward most point of attachment for the catcher 81 . A second anchoring attachment member 123 is seen in phantom and as supported underneath the tray 117 by any structural element. The second anchoring attachment member 123 will typically engage the fastener 87 to hold up the front of the catcher 81 . As will be shown, the overwhelming bulk of the force will be held by the first anchoring attachment member 121 and the fastener 85 because of the pulling stress due to an elastic member associated with the edge 51 . The portion of the catcher 81 at the curved edge 91 need only hold up the weight of the material adjacent the curved edge 91 and the fasteners 87 which are typically spaced apart are usually sufficient. [0046] Referring to FIG. 7 , a side view similar to that of FIG. 6 is shown, but where the catcher 81 has been attached. The attachment process can be started from either side of the high chair 101 by orienting the catcher 81 with its fastener 85 toward the first anchoring attachment member 121 and attaching it. The folded edge 51 of the catcher 81 is brought underneath the guided leg and foot support 115 to and around the other side so that the other fastener 85 can be pulled up to engage an oppositely located first anchoring attachment member 121 , while pulling the folded edge 51 against the force of an internal elastic member (not yet shown). [0047] The continuous stitch 53 seen in FIG. 7 gives an idea of the extent to which the folded edge 51 seeks the path of least length as the two fasteners 85 are oppositely stretched apart to their associated first anchoring attachment members 121 . Note that the guided leg and foot support 115 is at least partial enveloped between the edge 51 and the upper curved edge 91 which is shown as being loosely near the bottom front edge of the tray 117 . To operate as a catcher, is it only necessary that some minimum lower curvature be provided at or near a vicinity in which food and debris may fall. The guided leg and foot support 115 is shown as longer than may be available on some models of high chair. Other high chairs may have some obstruction a few inches upward from the lower rear area of the guided leg and foot support 115 , while others will have an abbreviated length guided leg and foot support 115 which may terminate before forming a foot support which is seen with respect to the high chair 101 of FIGS. 4 and 5 . A dart 125 is seen on the outside of the catcher 81 which was associated with dart cutting lines 41 and 43 . [0048] Referring to FIG. 8 a sectional view taken through the center of the high chair 101 seen in FIG. 7 illustrates further details of the catcher 81 and details of construction and attachment. Since the section is taken through the center of the high chair 101 with the catcher 81 in place, the leg 107 of the far side is not be shown in broken form as it does not obscure relevant details of the drawing. [0049] A smooth molded formfitting seat bottom and surface 129 is shown leading to a smooth form fitting lateral side and back surface 131 of the guided leg and foot support 115 . The transition between the bottom of the seat bottom and surface 129 and the back of lateral side and back surface 131 corresponds to area where the child's knee would bend. The seat bottom and surface 129 forms a natural funnel forward to the transition to the form fitting lateral side and back surface 131 with any food or debris able to escape to the floor upon which the high chair 101 is sitting only forward of the transition. [0050] However, because the catcher 81 is in place, a particle 133 of food or debris or a utensil 135 has no placed to go but into the bottom of the catcher 81 , where such particles 133 collect for later disposal. Other details seen are the structural tray members 137 which are usually extensive and accessible from underneath the tray 117 . Any available structure can be used to attach the second anchoring attachment member 123 to hold up the front of the catcher 81 . Also seen is dart 71 on the inside of the catcher 81 . [0051] When it is desired to dump the particles 133 , the user merely detaches the located fasteners 87 (since the front of the catcher will not likely fall forward with fasteners 85 still attached) and then simultaneously detach the fasteners 85 while bringing the whole catcher 81 low enough so that edge 51 (which remains significantly high above the lowest part of the catcher 81 to prevent spillage of the particles 133 ) clear the underneath portion of the guided leg and foot support 115 as it is brought forward. The catcher 81 can be then dumped into a receptacle and washed, if desired. [0052] While the present invention has been described in terms of a system and method for providing controllable capture of items dropped with respect to a high chair, one skilled in the art will realize that the structure and techniques of the present invention can be applied to many structures, including any structure or technique where an efficient capture and isolation of food, objects, utensils can be had with respect to a furniture object or child seat. [0053] Although the invention has been derived with reference to particular illustrative embodiments thereof, many changes and modifications of the invention may become apparent to those skilled in the art without departing from the spirit and scope of the invention. Therefore, included within the patent warranted hereon are all such changes and modifications as may reasonably and properly be included within the scope of this contribution to the art.

1a

[0001] [0000] References Cited: U.S. PATENT DOCUMENTS PAT. NO. Date Inventor Class 4,755,908 July, 1988 Gardner 361/326 4,776,323 October, 1988 Spector 601/23 5,271,627 December, 1993 Russell 273/445 5,722,418 March, 1998 Bro 600/545 5,742,748 April, 1998 Sever 345/419 5,792,025 August, 1998 Kikinis 482/1 6,605,038 August, 2003 Teller 600/300 6,846,270 January, 2005 Etnyre 482/6 7,255,666 August, 2007 Cardenas 482/143 7,297,093 November, 2007 Lopez 482/124 7,485,071 February, 2009 Edwards 482/23 7,488,282 February, 2009 Leavitt 482/142 8,025,606 September, 2011 Hamilton 482/4 8,096,923 January, 2012 White 482/23 8,167,777 May, 2012 Nichols 482/23 8,235,870 August, 2012 Hamilton 482/4 8,298,126 October, 2012 Berc 482/142 FIELD OF THE INVENTION [0002] This invention relates to apparatus for facilitating meditation practice. More specifically, the invention relates to a portable device that provides visual and or auditory queues for time based meditation. BACKGROUND OF THE INVENTION [0003] Prior art have mentioned meditation benefits for many years. For example, Hamilton, U.S. Pat. No. 8,235,870 and related U.S. Pat. No. 8,025,606 contemplate a physical exercise apparatus comprising a mat/cushion device and accessories designed for fitness interactivity using an array of variations of graphics specifically placed on the mat where the physical exercise device, wherein said graphics are arranged to support proper positioning and guidance for multiple forms of physical exercise including meditation techniques. Hamilton U.S. Pat. No. 8,235,870 FIGS. 1A, 1B, and 5 of show a mat with icons that are used to guide an exercise routine. Leavitt, U.S. Pat. No. 7,488,282, contemplates an exercise device and method of use thereof, including an exercise platform and an incline base that can be used together or separately. That invention relates to a device for exercising, more particularly relating to a yoga prop used for multidimensional exercises such as yoga, strength-training, aerobics and meditation. Leavitt U.S. Pat. No. 7,488,282 FIGS. 1a, 1b, and 1c of said device illustrate a sizable apparatus for physical exercise including an exercise platform and an incline base that can be used together or separately. Edwards, U.S. Pat. No. 7,485,071, contemplates composite yoga mats and straps comprising a fabric sheet and loop holes and/or filament loops functioning as hand grips or appendage supports useful in the practice of yoga positions that functionally support practitioners in the learning and practice of yoga positions and meditation. Similarly U.S. Pat. Nos. 7,485,071, 7,297,093, 7,255,666, 6,846,270, help to align posture. These prior art mention meditation as a side benefit of using said inventions. [0004] Teller, U.S. Pat. No. 6,605,038, provides a system for detecting, monitoring and reporting physiological information that includes a sensor device adapted to be worn on the upper arm that includes at least one of an accelerometer, a GSR sensor and a heat flux sensor and generates data indicative of at least one of activity, galvanic skin response and heat flow. Kikinis U.S. Pat. No. 5,792,025, contemplates a system to reduce repetitive motion injury risks, comprising a wrist-resting device having one or both of a heater and a vibrator in the device where such device can include software routines that launch a media player that presents on a computer video exercises, meditation, music, or a combination of any or all of these activities. Sever U.S. Pat. No. 5,742,748, also contemplates an invention that provides feedback through a computer program operable within a virtual reality device which is designed for perfecting mental visualization within the mind of a subject. Bro, U.S. Pat. No. 5,722,418, contemplates an invention for mediating social and behavioral influence processes through an interactive telecommunications guidance system. Russell, U.S. Pat. No. 5,271,627, contemplates a multidimensional equilateral angular game playing apparatus and method that includes electronically controlled, life-sized obelisk “opponents” in the vertex of each angle. And, Spector, U.S. Pat. No. 4,776,323, contemplates a biofeedback system to train an exerciser while who carries out athletic activity in which the arm or feet members move rhythmically and a system that translates this movement into an audible musical rhythm which makes it possible for the exerciser to be move in harmony with a musical rhythm conducive to optimal conditions of exercise. [0005] U.S. Pat. No. 4,755,908, Gardner, Jul. 5, 1988 contemplates a capacitor comprising a sealed hollow glass container, inductor means, a portion of which is mounted within said sealed glass container, two or more layers of material deposited on the exposed surfaces contained within the sealed glass container and a gaseous mixture filling said sealed glass container having a pressure, at 25.degree. C., of approximately 100 torr or more, the gases in said mixture being selected from a group of gases consisting of helium, neon, argon, krypton and xenon, which when used in implementation can cause oscillating electric and magnetic fields that produce a system that has several resonant frequencies, and which has been found to be beneficial in creating an environment for meditation. [0006] Prior art mentions meditation as a side benefit, but none are developed specifically to facilitate a meditation practice. More specifically none are developed to provide time based meditation with visual and auditory cues. In addition, many of these devices are large and not highly portable. Some prior art also use fragile glass containers that require high voltage and current, and complex systems that include integrated mechanical pumps, high pressure, and high vacuum systems, or entail large systems that require video, computer, and projections systems. [0007] Accordingly, it is an object of the present new and unique invention to facilitate a meditation practice. It is further the object of this invention to be conveniently sized to fit easily in a practitioner's purse. It is further the object of this invention to provide visual and or auditory queues to aid the meditation practice over a selectable period of time. Additional objects and advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the invention. SUMMARY OF THE INVENTION [0008] To achieve the foregoing objects and in accordance with the purpose of the invention as embodied and broadly described herein, the device of this invention is for guiding meditation including a body portion having a substantially planar lower surface and an ornamental exterior case. The interior of the invention includes electronic circuitry that provides auditory and or visual cues to facilitate meditation. The invention further contains user interface elements that allow the user to set the duration of the meditation session. Auditory cues are provided by recorded sound samples stored in the devices memory or loaded into the device by the user from time to time. Visual cues are provided by lighting elements such as but not limited to a liquid crystal display, bulb, or light emitting diode (LED). Preferably, the device allows the user to set the color of the visual queue and sound of the auditory queue. It is also preferred that the user can select the duration of the meditation session. BRIEF DESCRIPTION OF THE DRAWINGS [0009] 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. Of the Drawings [0010] FIG. 1 is a view of the invention; [0011] FIG. 2 is an exploded view of the invention; [0012] FIG. 3 is a view of the user interface; [0013] FIG. 4 is a schematic of the circuitry; [0014] FIG. 5 is a schematic of the software logic; [0015] FIG. 6 is an alternate embodiment; [0016] FIG. 7 is an alternate embodiment; [0017] FIG. 8 is an alternate embodiment; and [0018] FIG. 9 is an alternate embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT [0019] 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. As shown in FIG. 1 , the invention is a meditation device. In accordance with the invention, the device contains a body, user interface, and electronic circuitry. As shown in FIG. 2 , the body contains a top member 1 and bottom member 3 that enclose the circuit member 2 . The top and bottom member can be connected via a snap fits, screws, or other fastening method that is common to those skilled in the art. [0020] In accordance with the invention, the mediation device includes a user interface. As here embodied, the user interface includes general buttons that allow the user to set the meditation session duration and light color. As show in FIG. 3 , the invention contains a user interface element 4 that allows the user to set the duration of the meditation session and choose the color for the light that emits during the meditation session. [0021] A light selection wheel member 5 is turned to select the color of light to be emitted. Each section of member 5 contains a color. Color selection is made by turning a knob to the desired color. Those skilled in the art will appreciate the ability to use an alternative selection method such as but not limited to a capacitive touch panel or membrane switch panel commonly used in consumer electronics. A duration selection wheel member 6 is turned to set the duration of the meditation session. [0022] In accordance with the invention, electronics are provided that count time and provide light, sound, and vibration. As embodied herein, the electronics includes a microcontroller, battery, switch, light emitting diodes, speaker, and motor. As show in FIG. 4 , the invention contains electronic circuitry. A microcontroller member 7 contains the software that accepts input from the user interface element 4 . A battery member 9 provides power and a switch member 8 turns the device on and off. A plurality or singular light emitting diode (LED) member 10 provides light during the meditation session. A single LED can be used to provide one color. A set of red, green, and blue LEDs can be used to create a myriad of colors. Those skilled in the art will appreciate the ability to create said myriad of colors by varying the voltage delivered by the microcontroller member 7 to the LED members 10 . The voltage levels used with the set of red, green, and blue LED members 10 can be provided using pulse width modulation (PWM), which is common to those skilled in the art and described broadly in prior art. Sound is produced by the speaker member 11 , and vibration is produced by a motor member 12 . [0023] In accordance with the invention the microcontroller member 7 contains software that operates as a routine as shown in FIG. 5 . The software allows for a plurality of modes including but not limited to count down mode and light on mode. In this preferred embodiment if the countdown mode is selected, a color and duration is set. When start is pressed the software in microcontroller member 7 initiates the start cues that include light, sound, and vibration. Software then counts down until the end of the duration is reached. When the end of the duration is reached the software initiates end cues that include light, sound, and vibration and the device automatically turns off to conserve battery. [0024] While the preferred embodiment described is particularly used with a described set of buttons, light and sound elements, the invention may expand or simplify the interface in other embodiments. For example, embodiment FIG. 6 provides a much simplified interface member 13 that only contains a duration selection wheel member 14 . The embodiment in FIG. 7 provides an expanded interface member 15 that contains a light selection wheel member 16 , duration selection wheel member 17 , and sound selection wheel member 18 . [0025] It will be apparent to those skilled in the art that various modifications and variations can be made in the invention without departing from the scope or spirit of the invention. For example the embodiment in FIG. 8 provides an alternate interface member 19 that utilizes a light selection sliding switch member 20 in addition to the before mentioned duration selection wheel member 21 , repeated in this figure for clarity. The embodiment in FIG. 9 provides an alternate interface member 22 that utilizes a liquid crystal display (LCD) that contains icons for setting the duration, sound, and color. For example, the LCD can use light section icon 23 , sound section icon 24 , and duration section icon 25 . A touch sensing panel can be further integrated with the LCD allowing a user to select options from the LCD screen via finger press. It will be apparent to those skilled in the art that various modifications and variations can be made in the electronics without departing from the scope or spirit of the invention. For example a simplified circuit consisting of active and or passive components can be used to accomplish the device behavior noted in FIG. 5 . [0026] Thus, the invention provides a practical, novel, and useful device which may be economically manufactured, and which meets a need in the industry for meditation simplicity, utility, and portability.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is directed to a method for locating an examination site for conducting a diaphanoscopic examination of a living subject, as well as to an apparatus for implementing the method. 2. Description of the Prior Art In the framework of diaphanoscopic examinations, a region of a living subject to be examined is transilluminated with light and the transillumination image that is registered is utilized for diagnosis. If one wishes to detect a pathologically induced, optical change in a specific, transilluminated volume of the life form and make the result available as the basis of the diagnosis, then the selection of an “optimum” irradiation site must assure that the pathologically modifiable tissue penetrated by the photons is maximum compared to the pathologically constant volume in order to thus be able to actually examine the region of maximum information in the scope of the main examination. This is especially important when the pathological change to be detected is small. A diaphanoscopic examination method can, for example, be implemented at a finger joint in order to make a diagnosis with regard to rheumatoid arthritis. In simplified terms, a finger joint is composed of bone tissue, cartilage tissue, skin tissue and capsular tissue as well as joint fluid. The bone tissue, cartilage tissue as well as the surrounding skin tissue thereby remain pathologically constant in the early stage; the possible pathological changes occur only in joint capsule as well as the joint fluid. In order to obtain a maximum informational content with respect to this relatively narrow diagnostic volume in the framework of the main examination, it is necessary to implement the transillumination at the optimum examination site, so that the informational content that is obtained is as great as possible. The term examination location (or examination) being a tissue location prescribable on the basis of a position value, this being illuminated by the beam crossection of the light source employed for the examination. U.S. Pat. No. 5,452,723 discloses a spectroscopy method that is utilized in conjunction with spectroscopy of human tissue. With the method disclosed therein, the distortions of the obtained measured values are to be corrected given an examination of a thick tissue several millimeters thick due to the increased number of dispersion centers of the thick tissue compared to the spectroscopy of a very thin tissue only a few micrometers thick wherein fewer dispersion centers that influence the measured result are established. This ensues such that a spectrum of the diffuse reflectance is registered first, followed by the spectrum to be “distortion-corrected”, for example the fluorescence spectrum. An effective reflectance function is subsequently determined based on probability functions. The distortion-corrected fluorescence spectrum is then determined by dividing the registered fluorescence spectrum by the effective reflectance spectrum described on the basis of the effective reflectance function. The distortions of the spectrum of the thick tissue deriving from dispersion and absorption effects as well as the geometrical and the boundary surface conditions are eliminated, the spectrum curve that is obtained corresponds in good approximation to that of a thin tissue. The “distortion-corrected” measured curve that is obtained is subsequently compared to known reference curves, and the best fit curve is identified, this being subsequently investigated in view of the presence and concentration of reference fluorophores, which is the basis for the diagnosis of the corresponding tissue property. SUMMARY OF THE INVENTION An object of the present invention is to provide a method with which the optimum examination location for diaphanoscopic examinations of, for example, joints can be determined. The above object is achieved in accordance with the principles of the present invention in a method wherein a region of the life form in which the optimum examination location is suspected is sequentially transilluminated with a radiation in, preferably, a wavelength range of the optical tissue window for registering dispersed light distributions in the form of location-related spread functions, particularly point spread functions, whereby at least one function-specific, location-related feature of every spread function is identified, a position value defining the examination location being determined based thereon. The inventive method is based on the fact that, given a (punctiform) location-dependent transillumination of the tissue to be examined, scattered light distributions in the form of spread functions arise (point spread functions given punctiform irradiation), whose change in the form of scaling over the irradiation location are a function of the light propagation and that thus enable a statement about the optical conditions of the transilluminated, overall volume. Given knowledge of the optical properties of the tissue types present in the transilluminated volume, how the photons propagate when they penetrate mainly pathologically modifiable volume can then be determined, as can the form and scaling modification in which this is presented in the resulting scattered light distribution or, respectively, spread function. Inventively, thus, different spread functions, for example five spread functions, are registered at different irradiation locations, whereupon a function-specific, location related feature is determined on the basis of the respectively obtained spread function, i.e. a diagnostic characteristic of each function. After determining these features, these are further-processed in common and, based thereon, a position value is determined that defined the optimum examination location, i.e. based whereon the optimum examination site can be determined. For implementation, a region of the life form that covers the (expected) optimum examination site as a sub-region is transilluminated in chronological succession at a number of locations within the region. This, for example, can ensue in equidistant steps along a line, for instance parallel to the longitudinal axis of a finger (called x-axis below). A radiation in the wavelength range of the optical tissue window is preferably employed. Upon penetration of the tissue, the incoming light, which is (approximately) punctiform, is dispersed. The spatial distribution of the scattered light is acquired with a planar or line-shaped arrangement of light detectors. The intensity of the scattered light measured in this way as function of the location of the light detectors is referred to as a scattered light distribution function or also, more specifically, as a (point) spread function. For example. Eugene Hecht, “Optik”, Addison-Wesley-Verriag, 1989, pp. 512 ff., is referenced for more detailed explanation of the term “spread function”. The shape of the course of this spread function is dependent on the composition of the transirradiated tissue and, thus, is dependent on the selected irradiation location. A separate, characteristic spread function is thus obtained for each sequentially selected irradiation location. In general, function curves can be described (“parameterization” of a function) by one or more characteristic values (function-specific parameters or features), for example maximum value of the function, location of the maximum value of the function, location of the maximum slope or curvature of the function, etc. For the method disclosed herein, at least one or a mathematical operation of a number of description parameters of the function is selected, this being characteristic of the modification of the spread function given variation of the irradiation location, particularly for the differences in the form of the spread function given transirradiation of healthy and sick tissue. These parameters for describing the function curve of the measured spread functions are referred to below as function-specific, location-related features (related to the location of irradiation). The comparison of the values of these parameters then enables the selection of the irradiation location or optimum examination location that contains the most information about the pathological modification of the tissue. For example, location parameters, i.e. x-values, of the spread function with respect to distinguished points of the spread function can thus be determined as location-related, function-specific features and can be subsequently further-processed. For example, the respective position values, i.e. the x-values, of the maximums and/or of the centers of gravity of the spread functions can be inventively employed as features. The position value defining the examination location can thereby be inventively determined by forming the average from the position values of the maximums or of the centers of gravity. As has been shown in the framework of trials, the scattered light distributions that are obtained differ in diagnostic utility dependent on how close the respective irradiation location lies to the optimum examination location. Taking the optical properties of this tissue into consideration, it can be assumed that there is a high probability of finding a suitable irradiation location where the overall irradiation intensity (area of the resulting scattered light distribution) is high and the width of the resulting scattered light distribution is narrower compared to the distributions that exist given irradiation around this point. The informational content with respect to the individual spread functions in view of the determination of the examination location is thus respectively different. In order to counter this, an expedient development of the inventive idea provides that each function-specific, location-related feature is weighted with a weighting factor that can be expediently determined based on at least one, and possibly on more, function-specific features. By taking this weighting factor into consideration, thus, each spread function contributes differently to the identified position value, i.e. the function lying closer to or at the optimum examination location enters in significantly more strongly than those lying therebeside. Expediently, the weighting factor can be multiplicatively determined from the overall irradiation intensity and the standard deviation of each spread function, since the probability is high of finding a suitable irradiation location where the overall radiation intensity is high and the width of the scattered light distribution is low compared to distributions around this point. The weighting factors, further, can be normed to the highest identified weighting factor. The optimum examination site can be identified with adequate precision with the described determination method of the position value by averaging, potentially by weighted averaging, in order to be able to implement a diagnostically relevant examination. The determination of this examination site, however, ensues at the detector side since the spread functions that are obtained are determined at the detector side and the position values that are obtained are acquired from this information of the detector side. When, due to the physiological conditions of the transilluminated volume, the irradiation sites noticeably deviate from the identified, location-related position values obtained from the spread functions, the position value determined approximately at the detector side can be too imprecise in order to directly transfer it onto the irradiation plane. Given, for example, a finger joint, this can be produced in that the capsule tissue and the joint fluid have light-conducting properties and light coupled in here is in turn coupled out with priority at a specific position. In order to counter this in a further embodiment of the invention, after determining the position value, a back-transformation ensues into the irradiation plane. This can be expediently realized by determining a further position value for the back-transformation, the first position value that is determined and that refers to the detector side being shifted by this further position values. In other words, a correction value is determined as the further position value, this correction value compensating the offset between the irradiation location and the identified, first position value caused by the physiological conditions and being employed for the corresponding shift of the identified, first position value, so that the position value obtained as a result thereof characterizes the irradiation location in the irradiation plane. The offset between the irradiation-side irradiation location of the spread function with the highest overall irradiation intensity or the highest weighting factor and the detector-side position of the function maximum or of the center of gravity of this spread function can be inventively employed as further position value. The position datum or data can be inventively determined on the basis of the directly obtained spread functions or on the basis of a spread function smoothed at least in the region of the maximums, insofar as the course of the curve allows a corresponding determination exhibiting an acceptable error. When this is not possible with an acceptable error, in a further embodiment of the invention the spread functions that are obtained are approximated by means of respective approximation functions, and the position value or values are determined on the basis of the approximation functions. Expediently, each spread function can be approximated with one or more Gaussian functions. In addition to being directed to the inventive method, the invention is also directed to an apparatus for the implementation of the method. This apparatus an irradiation unit, a detector, a control unit and a computer, and the computer is fashioned for the determination of an optimum examination location according to the above-described method, and the control unit is fashioned for the control of the irradiation unit dependent on the determination result. Inventively, the irradiation unit can include a radiation source for a specific wavelength, and positioning unit controllable by the control unit can be provided for moving the radiation source. In this first embodiment of the invention, only one radiation source is utilized, this being moved via the corresponding positioning unit to the optimum examination site after determination thereof. Alternatively, the irradiation unit can include a number of radiation sources respectively for specific wavelengths that can be separately driven with the control unit. Positioning of the radiation sources is not absolutely required if this embodiment of the irradiation unit is fashioned grid-like, particularly when the grid dimension, i,e. the spacing of the radiation sources from one another, is selected adequately small. When the grid dimension is relatively coarse, a positioning unit can be inventively provided for moving at least one, preferably all radiation sources, the positioning unit being controllable via the control unit dependent on the determination result. Operation without a positioning unit can ensue, for example, by employing a grid of radiation sources that are closely spaced to each other within the grid, with only specific radiation sources, disposed at larger distances from each other within the grid, being energized for emitting radiation to determine the examination site. After determining the optimum examination site, another radiation source, which lies optimized relative to the optimum examination site due to the very small grid, can then be driven. The grid dimension of the radiation sources and the diameter of the respectively emitted light beam should have a ratio of approximately 1:1 through approximately 3:1, particularly 2:1. When the radiation sources are movable, a grid dimension of the radiation sources of approximately 250 μm through 750 μm, preferably 500 μm,, has proven expedient, whereby the beam diameter here should amount to approximately 125 μm through 500 μm, particularly 250 μm. Given immobile radiation sources, the grid dimension should be optimally small and lie in a range from approximately 125 μm through 500 μm, particularly at 250 μm. In order to locate the optimum examination site while also allowing the examination to be conducted at a number of wavelengths, which definitely leads to results with greater diagnostic utility, a number of radiation sources for respectively difficult wavelengths can be provided in the inventive apparatus. DESCRIPTION OF THE DRAWINGS FIG. 1 is a graph showing five scattered light distributions obtained in accordance with the invention. FIG. 2 shows five approximation curves calculated for the scattered light distributions of FIG. 1, as well as the respective centers of gravity associated therewith. FIG. 3 is a schematic block diagram of a first embodiment of an inventive apparatus. FIG. 4 is a schematic block diagram of a second embodiment of an inventive apparatus. DESCRIPTION OF THE PREFERRED EMBODIMENTS For a better understanding of the determination method described below with reference to an exemplary embodiment, the inventive apparatus for the implementation of this method, as shown, for example, in FIG. 3, will be described first. This apparatus is composed of an irradiation unit 1 , for example in the form of a laser with a wavelength of 675 nm. A detector 3 is provided thereopposite. The region of a living subject to be examined, a finger 4 in the illustrated example, is placed between irradiation unit 1 and detector 3 . In the region of a joint to be examined, this finger 4 is composed of skin tissue 5 , cartilage and bone tissue 6 as well as joint capsule tissue 7 and joint fluid 8 . A control unit 9 controls the operation and a computer 10 determines the optimum examination location from the data obtained by the detector 3 . Given this embodiment having only one radiation source 2 , the operation for determining the optimum examination location ensues such that the irradiation unit 1 together with the radiation source 2 is moved, for example, to five selected positions above the joint gap, whereby the mobility is indicated by the double arrow A. The positioning unit required for this purpose is not explicitly shown. A punctiform transillumination of the tissue then ensues at each of the selected locations. The respective scattered light distribution for each irradiation is registered with the detector 3 in the form of a point spread function and is supplied to the computer means 10 , which, on the basis of the method described below, determines the optimum examination site and supplies a signal indicating this site to the control unit 9 , which then causes the irradiation unit 1 to be driven and moved for the implementation of the actual examination, As already described, the scattered light distribution is registered for each of the predetermined irradiation locations around a defined zero position. Such scattered light distributions are shown in FIG. 1, wherein the location in mm around the zero position is indicated along the abscissa and the normalized irradiation intensity is indicated in 1/cm 2 along the ordinate. The arrows respectively indicate the irradiation location for the respective curves. The irradiation locations shown here lie distributed ±2 millimeters around the zero location, i.e. a total of five irradiation locations were selected. The respectively obtained scattered light distribution for each of the irradiation locations X −2 . . . X 2 is indicated with the reference characters K −2 . . . K 2 . As can be derived from FIG. 1, the course of the curve is still relatively noise-infested and allows only an inexact determination of the optimum examination location. To this end, an approximation curve A+ 2 . . . A +2 is determined for each of the curves K −2 . . . K +2 by approximation with a number of Gaussian functions. These approximation curves are shown in FIG. 2 . Moreover, the respective centers of gravity S −2 . . . S +2 of the curves are also determined for each curve A 2 . . . A 2 . The centers of gravity are not utilized for the determination of examination sites described below; however, the determination method could likewise be implemented based on these values. A series of function-specific, location-related features are then determined for determining the optimum examination location, as can be derived from the following table. TABLE irradiation x −2 = x −1 = x 0 = x 1 = x 2 = location (in mm) −2 mm 1 mm 0 mm 1 mm 2 mm x-value of E max (in mm) −1.6 −1.4 −1.2 −0.6 −0.8 Overall irradiation 50.0 50.8 42.4 47.0 39.7 intensity E ges Standard deviation s 6.898 6.793 6.74 6.807 5.914 Weighting factor W = 329.9 345.08 285.13 319.93 234.8 E ges *s Normed weighting factor 0.956 1 0.826 0.927 0.680 Weighted x-value of −1.53 −1.4 −0.99 0.56 0.54 E max (In mm) The x-values of the respective curve maximums E max are first determined on the basis of the approximation functions. As can be derived from line 2 of the Table, these respectively lie in the negative range. It is already possible to calculate a first examination location from these values by averaging. This would lie at X average =1.12 mm. For taking the actual amount of the scattered light distributions into consideration, it is expedient to determine a weighting factor and to take it into consideration in the formation of the average. Certain properties of the scattered light distribution such as the overall irradiation intensity E gea (=area under the respective curve) and the standard deviation (=width of the curve) are available for calculating this weighting factor. The values therefor determined with respect to the approximation function can be derived from lines 3 and 4 . Based thereon, it is possible to multiplicatively determine a weighting factor from these two values, whereby the values are recited in line 5 . Subsequently, the identified weighting factor is normalized to the highest weighting factor (line 6 ). When the identified x-values of E max (column 2 ) are now multiplied by the normalized weighting factors, then the weighted x-values of E max are obtained, as indicated in line 7 . The weighted average that can be calculated from these weighted values amounts to x average =1.004 mm and takes the respective amount of the individual scattered light distributions into account. Compared to the position value calculated unweighted, a difference of 0.116 mm thus derives. Subsequently, the weighted average that specifies the optimum location at the detector side must be back-transformed onto a coordinate of the excitation side. To this end, the offset between the irradiation location that supplies the highest weighting factor, or the highest E ges , and the position of E max of this scattered light distribution is employed In the illustrated exemplary embodiment, the irradiation position that supplies the scattered light distribution with the highest weighting factor is the irradiation location X 1 . The E max -position of this scattered light distribution is X Emax =1.4 mm. An offset of X 1 =X Emax =1 mm−(−1.4 mm) +0.4 mm derives therefrom. For back-transformation, the calculated, weighted average of 1.004 mm is shifted by this offset, so that the new zero position in the irradiation plane is selected as X optimum =0.604 mm. Instead of employing the x-values of E max , the disclosed determination method can be implemented in the same way based on the centers of gravity of the respective approximation functions. Finally, FIG. 4 shows a further embodiment of an inventive apparatus. The structure is largely the same as shown in FIG. 3; however, an irradiation unit 11 is employed in this embodiment that contains a number of radiation sources 12 . The radiation sources 12 are spaced from one another grid-like, whereby a grid of 500 μm or less, preferably 250 μm, is employed. In the illustrated exemplary embodiment, only seven radiation sources are indicated for clarity; the number, of course, is substantially greater in view of the selected grid spacing. The operation of this apparatus is such that, for example, only every other radiation source 12 is driven, whereby, of course, only those are driven that are in a correspondingly close position to the suspected, optimum examination site. After determining the optimum examination site, a radiation source 12 that is more beneficial because it lies closer to the examination location can then be driven via the control unit 9 , which is also present in this embodiment. Such an operation is possible given an adequately small spacing, for example 250 μm, Insofar as a larger grid spacing is selected (for example, 500 μm), it is likewise conceivable to provide for positioning of the irradiation unit 11 in order to move a selected radiation source to the optimum examination location. 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

INFORMATION ON RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 10/682,420, filed Oct. 10, 2003, now abandoned, which is a continuation of U.S. application Ser. No. 10/637,011, filed Aug. 8, 2003, now U.S. Pat. No. 7,223,594, which is a continuation of U.S. application Ser. No. 09/514,245, filed Feb. 28, 2000, now U.S. Pat. No. 6,703,023, which is a 35 U.S.C. § 120 continuation-in-part of International Application No. PCT/FR98/02634, filed Dec. 4, 1998, published in a non-English language, and now abandoned, each application of which is incorporated herein by reference. BACKGROUND OF THE INVENTION The invention relates to the genomic sequence and nucleotide sequences coding for polypeptides of PWD circovirus, such as the structural and nonstructural polypeptides of said circovirus, as well as vectors including said sequences and cells or animals transformed by these vectors. The invention likewise relates to methods for detecting these nucleic acids or polypeptides and kits for diagnosing infection by the PWD circovirus. The invention is also directed to a method for selecting compounds capable of modulating the viral infection. The invention further comprises pharmaceutical compositions, including vaccines, for the prevention and/or the treatment of viral infections by PWD circovirus as well as the use of a vector according to the invention for the prevention and/or the treatment of diseases by gene therapy. Piglet weight loss disease (PWD), alternatively called fatal piglet wasting (FPW) has been widely described in North America (Harding, J. C., 1997), and authors have reported the existence of a relationship between this pathology and the presence of porcine circovirus (Daft, B. et al., 1996; Clark, E. G., 1997; Harding, J. C., 1997; Harding, J. C. and Clark, E. G., 1997; Nayar, G. P. et al., 1997). A porcine circovirus has already been demonstrated in established lines of cell cultures derived from pigs and chronically infected (Tischer, I., 1986, 1988, 1995; Dulac, G. C., 1989; Edwards, S., 1994; Allan, G. M., 1995 and McNeilly, F., 1996). This virus, during experimental infection of piglets, does not prove pathogenic for pigs (Tischer, I., 1986, Horner, G. W., 1991) and its nucleotide sequence has been determined and characterized (Tischer, I., 1982; Meehan, B. M. et al., 1997; Mankertz., A., 1997). The porcine circovirus, called PCV virus, is part of the circovirus genus of the circoviridae family (Murphy, F. A. et al., 1995) whose virion has a circular DNA of size between 1.7 and 2.3 kb, which DNA comprises three open reading frames (ORF1 to ORF3), coding for a replication protein REP involved in the initiation and termination phase of rolling circular replication (RCR) (Heyraud-Nitschke, F., et al., 1995; Harding, M. R. et al., 1993; Hanson, S. F. et al., 1995; Fontes, E. P. B. et al., 1994), coding for a capsid protein (Boulton, L. H. et al., 1997; Hackland, A. F. et al., 1994; Chu, P. W. G. et al., 1993) and coding for a nonstructural protein called a dissemination protein (Lazarowitz., S. G. et al., 1989). The authors of the present invention have noticed that the clinical signs perceptible in pigs and linked to infection by the PWD circovirus are very distinctive. These manifestations in general appear in pigs of 8 to 12 weeks of age, weaned for 4 to 8 weeks. The first signs are hypotonia without it being possible to speak of prostration. Rapidly (48 hours), the flanks hollow, the line of the spine becomes apparent, and the pigs “blanch.” These signs are in general accompanied by hyperthermia, anorexia and most often by respiratory signs (coughing, dyspnea, polypnea). Transitory diarrhea can likewise appear. The disease state phase lasts approximately one month at the end of which the rate of mortality varies from 5 to 20%. To these mortalities, it is expedient to add a variable proportion (5-10%) of cadaveric animals which are no longer able to present an economic future. It is to be noted that outside of this critical stage of the end of post-weaning, no anomaly appears on the farms. In particular, the reproductive function is totally maintained. On the epidemiological level, the first signs of this pathology appeared at the start of 1995 in the east of the Côtes d'Armor region in France, and the farms affected are especially confined to this area of the region. In December 1996, the number of farms concerned could not be evaluated with precision because of the absence of a specific laboratory diagnostic method or of an epidemiological surveillance system of the livestock. Based on the clinical facts as well as on results of postmortem examinations supplied by veterinarians, it is possible to estimate this number as several dozen (80-100). The contiguousness of the disease is weak to moderate. Cases are being reported outside the initial area and for the majority are following the transfer of animals coming from farms familiar with the problem. On the other hand, a characteristic of the condition is its strong remanence. Thus, farms which have been affected for a year are still affected in spite of the massive administration of therapeutics. Farms with clinical expression are drawn from various categories of specialization (breeders/fatteners, post-weaners/fatteners) and different economic structures are concerned. In addition, the disorders appear even in farms where the rules of animal husbandry are respected. Numerous postmortem examinations have been carried out either on farms or in the laboratory. The elements of the lesional table are disparate. The most constant macroscopic lesions are pneumonia which sometimes appears in patchy form as well as hypertrophy of the lymphatic ganglia. The other lesions above all affect the thoracic viscera including, especially, pericarditis and pleurisy. However, arthritis and gastric ulcers are also observed. The lesions revealed in the histological examination are essentially situated at the pulmonary level (interstitial pneumonia), ganglionic level (lymphoid depletion of the lymph nodes, giant cells) and renal level (glomerulonephritis, vasculitis). The infectious agents have been the subject of wide research. It has been possible to exclude the intervention of pestiviruses and Aujeszky's disease. The disorders appear in the seropositive PDRS (Porcine Dysgenic and Respiratory Syndrome, an infection linked to an arteriovirus) herds, but it has not been possible to establish the role of the latter in the genesis of the disorders (the majority of the farms in Brittany are PDRS seropositive). The authors of the present invention, with the aim of identifying the etiological agent responsible for PWD, have carried out “contact” tests between piglets which are obviously “ill” and SPF pigs (specific pathogen-free) from CNEVA (Centre National d'Etudes Vétérinaires et Alimentaires, France). These tests allow the development of signs comparable to those observed on the farm to be observed in protected animal houses. The discrete signs such as moderate hyperthermia, anorexia and intermittent diarrhea appeared after one week of contact. It must be noted that the PDRS virus only diffused subsequent to the clinical signs. In addition, inoculations of organ homogenates of sick animals to healthy pigs allowed signs related to those observed on the farms to be reproduced, although with a lower incidence, linked to the favorable conditions of upkeep of the animals in the experimental installations. Thus, the authors of the present invention have been able to demonstrate that the pathological signs appear as a well-defined entity affecting the pig at a particular stage of its growth. This pathology has never been described in France. However, sparse information, especially Canadian, relates to similar facts. The disorders cannot be mastered with the existing therapeutics. The data collected both on the farm and by experimentation have allowed the following points to be highlighted: PWD is transmissible but its contagiousness is not very high, its etiological origin is of infectious and probably viral nature, PWD has a persistent character in the affected farms. Considerable economic consequences ensue for the farms. Thus, there is currently a significant need for a specific and sensitive diagnostic, whose production is practical and rapid, allowing the early detection of the infection. A reliable, sensitive and practical test which allows the distinction between strains of porcine circovirus (PCV) is thus strongly desirable. On the other hand, a need for efficient and well-tolerated treatment of infections with PWD circovirus likewise remains desirable, no vaccine currently being available against PWD circovirus. Concerning PWD circovirus, it will probably be necessary to understand the role of the immune defense in the physiology and the pathology of the disease to develop satisfactory vaccines. Fuller information concerning the biology of these strains, their interactions with their hosts, the associated infectivity phenomena and those of escape from the immune defenses of the host especially, and finally their implication in the development of associated pathologies, will allow a better understanding of these mechanisms. Taking into account the facts which have been mentioned above and which show in particular the limitations of combating infection by the PWD circovirus, it is thus essential today on the one hand to develop molecular tools, especially starting from a better genetic knowledge of the PWD circovirus, and likewise to perfect novel preventive and therapeutic treatments, novel methods of diagnosis and specific, efficacious and tolerated novel vaccine strategies. This is precisely the subject of the present invention. SUMMARY OF THE INVENTION The present invention relates to vaccines comprising a nucleotide sequence of the genome of Porcine circovirus type B, or a homologue or fragment thereof, and an acceptable pharmaceutical or veterinary vehicle. In one embodiment of the invention, the nucleotide sequence is selected from SEQ ID No. 15, SEQ ID No. 19 SEQ ID No. 23, or SEQ ID No. 25, or a homologue or fragment thereof. In another embodiment of the invention, the homologue has at least 80% sequence identity to SEQ ID No. 15, SEQ ID No. 19, SEQ ID No. 23 or SEQ ID No. 25. In yet another embodiment, the vaccines further comprising an adjuvant The present invention also relates to vaccines comprising a polypeptide encoded by a nucleotide sequence of the genome of PCVB, or a homologue or fragment thereof, and an acceptable pharmaceutical or veterinary vehicle. In one embodiment, the homologue has at least 80% sequence identity to SEQ ID No. 15, SEQ ID No. 19, SEQ ID No. 23 or SEQ ID No. 25. In another embodiment of the invention, the nucleotide sequence is selected from SEQ ID No. 23 or SEQ ID No. 25, or a homologue or fragment thereof. In still another embodiment, the polypeptide has the amino acid sequence of SEQ ID No. 24 or SEQ ID No. 26. In yet another embodiment, the homologue has at least 80% sequence identity to SEQ ID No. 24 or SEQ ID No. 26. In another embodiment, the polypeptide has the amino acid sequence of SEQ ID No. 29, SEQ ID No. 30, SEQ ID No. 31, or SEQ ID No. 32. A further aspect of the invention relates to vaccines comprising a vector and an acceptable pharmaceutical or veterinary vehicle, the vector comprising a nucleotide sequence of the genome of Porcine circovirus type B, or a homologue or fragment thereof. In one embodiment, the vaccine further comprises a gene coding for an expression product capable of inhibiting or retarding the establishment or development of a genetic or acquired disease. The present invention also relates to vaccines comprising a cell and an acceptable pharmaceutical or veterinary vehicle, wherein the cell is transformed with a nucleotide sequence of the genome of Porcine circovirus type B, or a homologue or fragment thereof. Still further, the present invention relates to vaccines comprising a pharmaceutically acceptable vehicle and a single polypetide, wherein the single polypeptide consists of SEQ ID No. 26. Additionally, the present invention relates to methods of immunizing a mammal against piglet weight loss disease comprising administering to a mammal an effective amount of the vaccines described above. These and other aspects of the invention will become apparent to the skilled artisan in view of the teachings contained herein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 : Experimental scheme which has made it possible to bring about the isolation and the identification of the circovirus associated with PWD of type A and B. Test 1: experimental reproduction of the PWD by inoculation of pig organ homogenates from farms affected by PWD. Test 2: experimental reproduction of PWD. Test 3: experimental reproduction of PWD. Test 4: no experimental reproduction of PWD. FIG. 2 : Organization of the genome of the circovirus associated with PWD of type A (PCVA) strand of (+) polarity (SEQ ID No. 1); strand of (−) polarity (SEQ ID No. 5, represented according to the orientation 3′→5′); sequences of amino acids of proteins encoded by the two DNA strands in the three possible reading frames SEQ ID NOS: 2-4 and 6-8 respectively. FIG. 3 : Alignment of the nucleotide sequence SEQ ID No. 1 of the PWD circovirus of type A (PCVA) and of the MEEHAN SEQ ID No. 163 strain and MANKERTZ SEQ ID No. 164 strain circoviruses of the porcine cell lines. FIG. 4 : Alignment of the sequence of amino acids SEQ ID No. 10 of a polypeptide encoded by the nucleotide sequence SEQ ID No. 9 (ORF1) of the PWD circovirus of type A (PCVA) and of corresponding nucleotide sequences of the MEEHAN SEQ ID No. 165 strain and MANKERTZ SEQ ID No. 166 strain circoviruses of the porcine cell lines. FIG. 5 : Alignment of the sequence of amino acids SEQ ID No. 12 of a polypeptide encoded by the nucleotide sequence SEQ ID No. 11 (ORF2) of the PWD circovirus of type A (PCVA) and of corresponding nucleotide sequences of the MEEHAN SEQ ID No. 167 strain and MANKERTZ SEQ ID No. 168 strain circoviruses of the porcine cell lines. FIG. 6 : Alignment of the sequence of amino acids SEQ ID No. 14 of a polypeptide encoded by the nucleotide sequence SEQ ID No. 13 (ORF3) of the PWD circovirus of type A (PCVA) and of corresponding nucleotide sequences of the MEEHAN SEQ ID No. 169 strain and MANKERTZ SEQ ID No. 170 strain circoviruses of the porcine cell lines. FIG. 7 : Western blot analysis of recombinant proteins of the PWD circovirus of type A (PCVA). The analyses were carried out on cell extracts of Sf9 cells obtained after infection with recombinant baculovirus PCF ORF1. FIG. 8 : Organization of the genome of the circovirus associated with the PWD of type B (PCVB) strand of (+) polarity (SEQ ID No. 15); strand of (−) polarity (SEQ ID No. 19, represented according to the orientation 3′→5′); sequence of amino acids of proteins encoded by the two DNA strands in the three possible reading frames SEQ ID NOS: 16-18 and 20-22 respectively. FIG. 9 : Evolution of the daily mean gain (DMG) of pig farms affected by piglet weight loss disease (PWD), placed under experimental conditions. FIG. 10 : DMG compared for the 3 batches of pigs (F1, F3 and F4) calculated over a period of 28 days, after vaccination test. FIG. 11 : Hyperthermia greater than 41° C., expressed as a percentage compared for the 3 batches of pigs (F1, F3 and F4) calculated per week over a period of 28 days, after vaccination test. FIG. 12 : Membranes of peptide spots corresponding to the ORF2s revealed with the aid of an infected pig serum, originating from a conventional farm. The numbers of specific peptides of the circovirus of type B as well as their nonreactive homologs (type A) are indicated in bold. The nonspecific immunogenic peptides are indicated in italics. FIG. 13 : Alignment of amino acid sequences of proteins encoded by the ORF2 of the PWD circovirus of type A SEQ ID No. 12 and by the ORF′2 of the PWD circovirus of type B SEQ ID No. 26. The position of 4 peptides corresponding to specific epitopes of the PWD circovirus of type B is indicated on the corresponding sequence by a bold line, their homolog on the sequence of the PWD circovirus of type A is likewise indicated by an ordinary line. FIG. 14 : Charts the results of experiments that demonstrate, in terms of percent hyperthermia, that vaccination with ORF′1 and ORF′2 of PCV-B enhances the level of protection in swine challenged with PCV-B. FIG. 15 : Charts the results of experiments that demonstrate, in terms of animal growth, that vaccination with ORF′1 and ORF′2 of PCV-B enhances the level of protection in swine challenged with PCV-B. FIG. 16 : Immunoperoxidase staining of PK15 cells at 24 h post-transfection with the pcDNA3/ORF′2 plasmid. Expression of PCVB ORF′2 was confirmed by IPMA following incubation in the presence of the swine anti-PCVB monospecific serum DETAILED DESCRIPTION OF THE INVENTION The present invention relates to nucleotide sequences of the genome of PWD circovirus selected from the sequences SEQ ID No. 1, SEQ ID No. 5, SEQ ID No. 15, SEQ ID No. 19 or one of their fragments. The nucleotide sequences of sequences SEQ ID No. 1 and SEQ ID No. 5 correspond respectively to the genome sequence of the strand of (+) polarity and of the strand of (−) polarity of the PWD circovirus of type A (or PCVA), the sequence SEQ ID No. 5 being represented according to the orientation 5′→3′. The nucleotide sequences of sequences SEQ ID No. 15 and SEQ ID No. 19 correspond respectively to the genome sequence of the strand of (+) polarity and of the strand of (−) polarity of the PWD circovirus of type B (or PCVB), the sequence SEQ ID No. 19 being represented according to the orientation 5′→3′. The present invention likewise relates to nucleotide sequences, characterized in that they are selected from: a) a nucleotide sequence of a specific fragment of the sequence SEQ ID No. 1, SEQ ID No. 5, SEQ ID No. 15, SEQ ID No. 19 or one of their fragments; b) a nucleotide sequence homologous to a nucleotide sequence such as defined in a); c) a nucleotide sequence complementary to a nucleotide sequence such as defined in a) or b), and a nucleotide sequence of their corresponding RNA; d) a nucleotide sequence capable of hybridizing under stringent conditions with a sequence such as defined in a), b) or c); e) a nucleotide sequence comprising a sequence such as defined in a), b), c) or d); and f) a nucleotide sequence modified by a nucleotide sequence such as defined in a), b), c), d) or e). Nucleotide, polynucleotide or nucleic acid sequence will be understood according to the present invention as meaning both a double-stranded or single-stranded DNA in the monomeric and dimeric (so-called in tandem) forms and the transcription products of said DNAs. It must be understood that the present invention does not relate to the genomic nucleotide sequences taken in their natural environment, that is to say in the natural state. It concerns sequences which it has been possible to isolate, purify or partially purify, starting from separation methods such as, for example, ion-exchange chromatography, by exclusion based on molecular size, or by affinity, or alternatively fractionation techniques based on solubility in different solvents, or starting from methods of genetic engineering such as amplification, cloning and subcloning, it being possible for the sequences of the invention to be carried by vectors. The nucleotide sequences SEQ ID No. 1 and SEQ ID No. 15 were obtained by sequencing of the genome by the Sanger method. Nucleotide sequence fragment according to the invention will be understood as designating any nucleotide fragment of the PWD circovirus, type A or B, of length of at least 8 nucleotides, preferably at least 12 nucleotides, and even more preferentially at least 20 consecutive nucleotides of the sequence from which it originates. Specific fragment of a nucleotide sequence according to the invention will be understood as designating any nucleotide fragment of the PWD circovirus, type A or B, having, after alignment and comparison with the corresponding fragments of known porcine circoviruses, at least one nucleotide or base of different nature. For example, the specific nucleotide fragments of the PWD circovirus of type A can easily be determined by referring to FIG. 3 of the present invention in which the nucleotides or bases of the sequence SEQ ID No. 1 (circopordfp) are shown which are of different nature, after alignment of said sequence SEQ ID No. 1 with the other two sequences of known porcine circovirus (circopormeeh and circopormank). Homologous nucleotide sequence in the sense of the present invention is understood as meaning a nucleotide sequence having at least a percentage identity with the bases of a nucleotide sequence according to the invention of at least 80%, preferably 90% or 95%, this percentage being purely statistical and it being possible to distribute the differences between the two nucleotide sequences at random and over the whole of their length. Specific homologous nucleotide sequence in the sense of the present invention is understood as meaning a homologous nucleotide sequence having at least one nucleotide sequence of a specific fragment, such as defined above. Said “specific” homologous sequences can comprise, for example, the sequences corresponding to the genomic sequence or to the sequences of its fragments representative of variants of PWD circovirus of type A or B. These specific homologous sequences can thus correspond to variations linked to mutations within strains of PWD circovirus of type A and B, and especially correspond to truncations, substitutions, deletions and/or additions of at least one nucleotide. Said homologous sequences can likewise correspond to variations linked to the degeneracy of the genetic code. The term “degree or percentage of sequence homology” refers to “degree or percentage of sequence identity between two sequences after optimal alignment” as defined in the present application. Two amino-acids or nucleotidic sequences are said to be “identical” if the sequence of amino-acids or nucleotidic residues, in the two sequences is the same when aligned for maximum correspondence as described below. Sequence comparisons between two (or more) peptides or polynucleotides are typically performed by comparing sequences of two optimally aligned sequences over a segment or “comparison window” to identify and compare local regions of sequence similarity. Optimal alignment of sequences for comparison may be conducted by the local homology algorithm of Smith and Waterman, Ad. App. Math 2: 482 (1981), by the homology alignment algorithm of Neddleman and Wunsch, J. Mol. Biol. 48: 443 (1970), by the search for similarity method of Pearson and Lipman, Proc. Natl. Acad. Sci . (U.S.A.) 85: 2444 (1988), by computerized implementation of these algorithms (GAP, BESTFIT, FASTA, and TFASTA in the Wisconsin Genetics Software Package, Genetics Computer Group (GCG), 575 Science Dr., Madison, Wis.), or by visual inspection. “Percentage of sequence identity” (or degree or identity) is determined by comparing two optimally aligned sequences over a comparison window, where the portion of the peptide or polynucleotide sequence in the comparison window may comprise additions or deletions (i.e., gaps) as compared to the reference sequence (which does not comprise additions or deletions) for optimal alignment of the two sequences. The percentage is calculated by determining the number of positions at which the identical amino-acid residue or nucleic acid base occurs in both sequences to yield the number of matched positions, dividing the number of matched positions by the total number of positions in the window of comparison and multiplying the result by 100 to yield the percentage of sequence identity. The definition of sequence identity given above is the definition that would use one of skill in the art. The definition by itself does not need the help of any algorithm, said algorithms being helpful only to achieve the optimal alignments of sequences, rather than the calculation of sequence identity. From the definition given above, it follows that there is a well defined and only one value for the sequence identity between two compared sequences which value corresponds to the value obtained for the best or optimal alignment. In the BLAST N or BLAST P “BLAST 2 sequence”, software which is available in the web site http://www.ncbi.nlm.nih.gov/gorf/bl2.html, and habitually used by the inventors and in general by the skilled man for comparing and determining the identity between two sequences, gap cost which depends on the sequence length to be compared is directly selected by the software (i.e. 11.2 for substitution matrix BLOSUM-62 for length>85). In the present description, PWD circovirus will be understood as designating the circoviruses associated with piglet weight loss disease (PWD) of type A (PCVA) or type B (PCVB), defined below by their genomic sequence, as well as the circoviruses whose nucleic sequences are homologous to the sequences of PWD circoviruses of type A or B, such as in particular the circoviruses corresponding to variants of the type A or of the type B. Complementary nucleotide sequence of a sequence of the invention is understood as meaning any DNA whose nucleotides are complementary to those of the sequence of the invention, and whose orientation is reversed (antiparallel sequence). Hybridization under conditions of stringency with a nucleotide sequence according to the invention is understood as meaning a hybridization under conditions of temperature and ionic strength chosen in such a way that they allow the maintenance of the hybridization between two fragments of complementary DNA. By way of illustration, conditions of great stringency of the hybridization step with the aim of defining the nucleotide fragments described above are advantageously the following. The hybridization is carried out at a preferential temperature of 65° C. in the presence of SSC buffer, 1×SSC corresponding to 0.15 M NaCl and 0.05 M Na citrate. The washing steps, for example, can be the following: 2×SSC, at ambient temperature followed by two washes with 2×SSC, 0.5% SDS at 65° C.; 2×0.5×SSC, 0.5% SDS; at 65° C. for 10 minutes each. The conditions of intermediate stringency, using, for example, a temperature of 42° C. in the presence of a 2×SSC buffer, or of less stringency, for example a temperature of 37° C. in the presence of a 2×SSC buffer, respectively require a globally less significant complementarity for the hybridization between the two sequences. The stringent hybridization conditions described above for a polynucleotide with a size of approximately 350 bases will be adapted by the person skilled in the art for oligonucleotides of greater or smaller size, according to the teaching of Sambrook et al., 1989. Among the nucleotide sequences according to the invention, those are likewise preferred which can be used as a primer or probe in methods allowing the homologous sequences according to the invention to be obtained, these methods, such as the polymerase chain reaction (PCR), nucleic acid cloning and sequencing, being well known to the person skilled in the art. Among said nucleotide sequences according to the invention, those are again preferred which can be used as a primer or probe in methods allowing the presence of PWD circovirus or one of its variants such as defined below to be diagnosed. The nucleotide sequences according to the invention capable of modulating, of inhibiting or of inducing the expression of PWD circovirus gene, and/or capable of modulating the replication cycle of PWD circovirus in the host cell and/or organism are likewise preferred. Replication cycle will be understood as designating the invasion and the multiplication of PWD circovirus, and its propagation from host cell to host cell in the host organism. Among said nucleotide sequences according to the invention, those corresponding to open reading frames, called ORF sequences, and coding for polypeptides, such as, for example, the sequences SEQ ID No. 9 (ORF1), SEQ ID No. 11 (ORF2) and SEQ ID No. 13 (ORF3) respectively corresponding to the nucleotide sequences between the positions 47 and 985 determined with respect to the position of the nucleotides on the sequence SEQ ID No. 1, the positions 1723 and 1022 and the positions 658 and 38 with respect to the position of the nucleotides on the sequence SEQ ID No. 5 (represented according to the orientation 3′→5′), the ends being included, or alternatively the sequences SEQ ID No. 23 (ORF′1), SEQ ID No. 25 (ORF′2) and SEQ ID No. 27 (ORF′3), respectively corresponding to the sequences between the positions 51 and 995 determined with respect to the position of the nucleotides on the sequence SEQ ID No. 15, the positions 1734 and 1033 and the positions 670 and 357, the positions being determined with respect to the position of the nucleotides on the sequence SEQ ID No. 19 (represented according to the orientation 3′→5′), the ends being included, are finally preferred. The nucleotide sequence fragments according to the invention can be obtained, for example, by specific amplification, such as PCR, or after digestion with appropriate restriction enzymes of nucleotide sequences according to the invention, these methods in particular being described in the work of Sambrook et al., 1989. Said representative fragments can likewise be obtained by chemical synthesis when their size is not very large and according to methods well known to persons skilled in the art. Modified nucleotide sequence will be understood as meaning any nucleotide sequence obtained by mutagenesis according to techniques well known to the person skilled in the art, and containing modifications with respect to the normal sequences according to the invention, for example mutations in the regulatory and/or promoter sequences of polypeptide expression, especially leading to a modification of the rate of expression of said polypeptide or to a modulation of the replicative cycle. Modified nucleotide sequence will likewise be understood as meaning any nucleotide sequence coding for a modified polypeptide such as defined below. The present invention relates to nucleotide sequences of PWD circovirus according to the invention, characterized in that they are selected from the sequences SEQ ID No. 9, SEQ ID No. 11, SEQ ID No. 13, SEQ ID No. 23, SEQ ID No. 25, SEQ ID No. 27 or one of their fragments. The invention likewise relates to nucleotide sequences characterized in that they comprise a nucleotide sequence selected from: a) a nucleotide sequence SEQ ID No. 9, SEQ ID No. 11, SEQ ID No. 13, SEQ ID No. 23, SEQ ID No. 25, SEQ ID No. 27 or one of their fragments; b) a nucleotide sequence of a specific fragment of a sequence such as defined in a); c) a homologous nucleotide sequence having at least 80% identity with a sequence such as defined in a) or b); d) a complementary nucleotide sequence or sequence of RNA corresponding to a sequence such as defined in a), b) or c); and e) a nucleotide sequence modified by a sequence such as defined in a), b), c) or d). As far as homology with the nucleotide sequences SEQ ID No. 9, SEQ ID No. 11, SEQ ID No. 13, SEQ ID No. 23, SEQ ID No. 25, SEQ ID No. 27 or one of their fragments is concerned, the homologous, especially specific, sequences having a percentage identity with one of the sequences SEQ ID No. 9, SEQ ID No. 11, SEQ ID No. 13, SEQ ID No. 23, SEQ ID No. 25, SEQ ID No. 27 or one of their fragments of at least 80%, preferably 90% or 95%, are preferred. Said specific homologous sequences can comprise, for example, the sequences corresponding to the sequences ORF1, ORF2, ORF3, ORF′1, ORF′2 and ORF′3 of PWD circovirus variants of type A or of type B. In the same manner, these specific homologous sequences can correspond to variations linked to mutations within strains of PWD circovirus of type A or of type B and especially correspond to truncations, substitutions, deletions and/or additions of at least one nucleotide. Among nucleotide sequences according to the invention, the sequence SEQ ID No. 23 which has a homology having more than 80% identity with the sequence SEQ ID No. 9, as well as the sequence SEQ ID No. 25, are especially preferred. Preferably, the invention relates to the nucleotide sequences according to the invention, characterized in that they comprise a nucleotide sequence selected from the following sequences: a) SEQ ID No.33  170 5′ TG T GG C GA 3′; b) SEQ ID No.34  450 5′ AG T TTCCT 3′; c) SEQ ID No.35 1026 5′ T C ATTTAGAGGGTCTTT C AG 3′; d) SEQ ID No.36 1074 5′ GTCA A CCT 3′; e) SEQ ID No.37 1101 5′ GTGG T TGC 3′; f) SEQ ID No.38 1123 5′ AGCC C AGG 3′; g) SEQ ID No.39 1192 5′ TTGG C TGG 3′; h) SEQ ID No.40 1218 5′ TC T AGCTC T GGT 3′; i) SEQ ID No.41 1501 5′ ATCT C AG C T C GT 3′; j) SEQ ID No.42 1536 5′ T G TCCTCCT C TT 3′; k) SEQ ID No.43 1563 5′ TCT C TAGA 3′; l) SEQ ID No.44 1623 5′ TGT A CCAA 3′; m) SEQ ID No.45 1686 5′ TCC G TCTT 3′; and their complementary sequences. In the list of nucleotide sequences a)-m) above, the underlined nucleotides are mutated with respect to the two known sequences of circovirus which are nonpathogenic to pigs. The number preceding the nucleotide sequence represents the position of the first nucleotide of said sequence in the sequence SEQ ID No. 1. The invention comprises the polypeptides encoded by a nucleotide sequence according to the invention, preferably a polypeptide whose sequence is represented by a fragment, especially a specific fragment, of one of the six sequences of amino acids represented in FIG. 2 , these six amino acid sequences corresponding to the polypeptides which can be encoded according to one of the three possible reading frames of the sequence SEQ ID No. 1 or of the sequence SEQ ID No. 5, or a polypeptide whose sequence is represented by a fragment, especially a specific fragment, of one of the six sequences of amino acids shown in FIG. 8 , these six sequences of amino acids corresponding to the polypeptides which can be encoded according to one of the three possible reading frames of the sequence SEQ ID No. 15 or of the sequence SEQ ID No. 19. The invention likewise relates to the polypeptides, characterized in that they comprise a polypeptide selected from the amino acid sequences SEQ ID No. 10, SEQ ID No. 12, SEQ ID No. 14, SEQ ID No. 24, SEQ ID No. 26, SEQ ID No. 28 or one of their fragments. Among the polypeptides according to the invention, the polypeptide of amino acid sequence SEQ ID No. 24 which has a homology having more than 80% identity with the sequence SEQ ID No. 10, as well as the polypeptide of sequence SEQ ID No. 26, are especially preferred. The invention also relates to the polypeptides, characterized in that they comprise a polypeptide selected from: a) a specific fragment of at least 5 amino acids of a polypeptide of an amino acid sequence according to the invention; b) a polypeptide homologous to a polypeptide such as defined in a); c) a specific biologically active fragment of a polypeptide such as defined in a) or b); and d) a polypeptide modified by a polypeptide such as defined in a), b) or c). Among the polypeptides according to the invention, the polypeptides of amino acid sequences SEQ ID No. 29, SEQ ID No. 30, SEQ ID No. 31 and SEQ ID No. 32 are also preferred, these polypeptides being especially capable of specifically recognizing the antibodies produced during infection by the PWD circovirus of type B. These polypeptides thus have epitopes specific for the PWD circovirus of type B and can thus be used in particular in the diagnostic field or as immunogenic agent to confer protection in pigs against infection by PWD circovirus, especially of type B. In the present description, the terms polypeptide, peptide and protein are interchangeable. It must be understood that the invention does not relate to the polypeptides in natural form, that is to say that they are not taken in their natural environment but that they can be isolated or obtained by purification from natural sources, or else obtained by genetic recombination, or alternatively by chemical synthesis and that they can thus contain unnatural amino acids, as will be described below. Polypeptide fragment according to the invention is understood as designating a polypeptide containing at least 5 consecutive amino acids, preferably 10 consecutive amino acids or 15 consecutive amino acids. In the present invention, specific polypeptide fragment is understood as designating the consecutive polypeptide fragment encoded by a specific fragment nucleotide sequence according to the invention. Homologous polypeptide will be understood as designating the polypeptides having, with respect to the natural polypeptide, certain modifications such as, in particular, a deletion, addition or substitution of at least one amino acid, a truncation, a prolongation, a chimeric fusion, and/or a mutation. Among the homologous polypeptides, those are preferred whose amino acid sequence has at least 80%, preferably 90%, homology with the sequences of amino acids of polypeptides according to the invention. Specific homologous polypeptide will be understood as designating the homologous polypeptides such as defined above and having a specific fragment of polypeptide according to the invention. In the case of a substitution, one or more consecutive or nonconsecutive amino acids are replaced by “equivalent” amino acids. The expression “equivalent” amino acid is directed here at designating any amino acid capable of being substituted by one of the amino acids of the base structure without, however, essentially modifying the biological activities of the corresponding peptides and such that they will be defined by the following. These equivalent amino acids can be determined either by depending on their structural homology with the amino acids which they substitute, or on results of comparative tests of biological activity between the different polypeptides, which are capable of being carried out. By way of example, the possibilities of substitutions capable of being carried out without resulting in an extensive modification of the biological activity of the corresponding modified polypeptides will be mentioned, the replacement, for example, of leucine by valine or isoleucine, of aspartic acid by glutamic acid, of glutamine by asparagine, of arginine by lysine etc., the reverse substitutions naturally being envisageable under the same conditions. The specific homologous polypeptides likewise correspond to polypeptides encoded by the specific homologous nucleotide sequences such as defined above and thus comprise in the present definition the polypeptides which are mutated or correspond to variants which can exist in PWD circovirus, and which especially correspond to truncations, substitutions, deletions and/or additions of at least one amino acid residue. Specific biologically active fragment of a polypeptide according to the invention will be understood in particular as designating a specific polypeptide fragment, such as defined above, having at least one of the characteristics of polypeptides according to the invention, especially in that it is: capable of inducing an immunogenic reaction directed against a PWD circovirus; and/or capable of being recognized by a specific antibody of a polypeptide according to the invention; and/or capable of linking to a polypeptide or to a nucleotide sequence of PWD circovirus; and/or capable of exerting a physiological activity, even partial, such as, for example, a dissemination or structural (capsid) activity; and/or capable of modulating, of inducing or of inhibiting the expression of PWD circovirus gene or one of its variants, and/or capable of modulating the replication cycle of PWD circovirus in the cell and/or the host organism. The polypeptide fragments according to the invention can correspond to isolated or purified fragments naturally present in a PWD circovirus or correspond to fragments which can be obtained by cleavage of said polypeptide by a proteolytic enzyme, such as trypsin or chymotrypsin or collagenase, or by a chemical reagent, such as cyanogen bromide (CNBr) or alternatively by placing said polypeptide in a very acidic environment, for example at pH 2.5. Such polypeptide fragments can likewise just as easily be prepared by chemical synthesis, from hosts transformed by an expression vector according to the invention containing a nucleic acid allowing the expression of said fragments, placed under the control of appropriate regulation and/or expression elements. “Modified polypeptide” of a polypeptide according to the invention is understood as designating a polypeptide obtained by genetic recombination or by chemical synthesis as will be described below, having at least one modification with respect to the normal sequence. These modifications will especially be able to bear on amino acids at the origin of a specificity, of pathogenicity and/or of virulence, or at the origin of the structural conformation, and of the capacity of membrane insertion of the polypeptide according to the invention. It will thus be possible to create polypeptides of equivalent, increased or decreased activity, and of equivalent, narrower, or wider specificity. Among the modified polypeptides, it is necessary to mention the polypeptides in which up to 5 amino acids can be modified, truncated at the N- or C-terminal end, or even deleted or added. As is indicated, the modifications of the polypeptide will especially have as objective: to render it capable of modulating, of inhibiting or of inducing the expression of PWD circovirus gene and/or capable of modulating the replication cycle of PWD circovirus in the cell and/or the host organism, of allowing its incorporation into vaccine compositions, of modifying its bioavailability as a compound for therapeutic use. The methods allowing said modulations on eukaryotic or prokaryotic cells to be demonstrated are well known to the person skilled in the art. It is likewise well understood that it will be possible to use the nucleotide sequences coding for said modified polypeptides for said modulations, for example through vectors according to the invention and described below, in order, for example, to prevent or to treat the pathologies linked to the infection. The preceding modified polypeptides can be obtained by using combinatorial chemistry, in which it is possible to systematically vary parts of the polypeptide before testing them on models, cell cultures or microorganisms for example, to select the compounds which are most active or have the properties sought. Chemical synthesis likewise has the advantage of being able to use: unnatural amino acids, or nonpeptide bonds. Thus, in order to improve the duration of life of the polypeptides according to the invention, it may be of interest to use unnatural amino acids, for example in D form, or else amino acid analogs, especially sulfur-containing forms, for example. Finally, it will be possible to integrate the structure of the polypeptides according to the invention, its specific or modified homologous forms, into chemical structures of polypeptide type or others. Thus, it may be of interest to provide at the N- and C-terminal ends compounds not recognized by the proteases. The nucleotide sequences coding for a polypeptide according to the invention are likewise part of the invention. The invention likewise relates to nucleotide sequences utilizable as a primer or probe, characterized in that said sequences are selected from the nucleotide sequences according to the invention. Among the pairs of nucleotide sequences utilizable as a pair of primers according to the invention, the pairs of primers selected from the following pairs are preferred: a) SEQ ID No.46 5′ GTG TGC TCG ACA TTG GTG TG 3′, and SEQ ID No.47 5′ TGG AAT GTT AAC GAG CTG AG 3′; b) SEQ ID No.46 5′ GTG TGC TCG ACA TTG GTG TG 3′, and SEQ ID No.48 5′ CTC GCA GCC ATC TTG GAA TG 3′; c) SEQ ID No.49 5′ CGC GCG TAA TAC GAC TCA CT 3′, and SEQ ID No.46 5′ GTG TGC TCG ACA TTG GTG TG 3′; d) SEQ ID No.49 5′ CGC GCG TAA TAC GAC TCA CT 3′, and SEQ ID No.48 5′ CTC GCA GCC ATC TTG GAA TG 3′; and e) SEQ ID No.50 5′ CCT GTC TAC TGC TGT GAG TAC CTT GT 3′, and SEQ ID No.51 5′ GCA GTA GAC AGG TCA CTC CGT TGT CC 3′. The cloning and the sequencing of the PWD circovirus, type A and B, has allowed it to be identified, after comparative analysis with the nucleotide sequences of other porcine circoviruses, that, among the sequences of fragments of these nucleic acids, were those which are strictly specific to the PWD circovirus of type A, of type B or of type A and B, and those which correspond to a consensus sequence of porcine circoviruses other than the PWD circoviruses of type A and/or B. There is likewise a great need for nucleotide sequences utilizable as a primer or probe specific to the whole of the other known and nonpathogenic porcine circoviruses. Said consensus nucleotide sequences specific to all circoviruses, other than PWD circovirus of type A and B, are easily identifiable from FIG. 3 and the sequence SEQ ID No. 15, and are part of the invention. Among said consensus nucleotide sequences, that which is characterized in that it is part of the following pair of primers is preferred: a) SEQ ID No.46 5′ GTG TGC TCG ACA TTG GTG TG 3′, and SEQ ID No.52 5′ TGG AAT GTT AAC TAC CTC AA 3′. The invention likewise comprises a nucleotide sequence according to the invention, characterized in that said sequence is a specific consensus sequence of porcine circovirus other than PWD circovirus of type B and in that it is one of the primers of the following pairs of primers: a) SEQ ID No.53 5′ GGC GGC GCC ATC TGT AAC GGT TT 3′, and SEQ ID No.54 5′ GAT GGC GCC GAA AGA CGG GTA TC 3′. It is well understood that the present invention likewise relates to specific polypeptides of known porcine circoviruses other than PWD circovirus, encoded by said consensus nucleotide sequences, capable of being obtained by purification from natural polypeptides, by genetic recombination or by chemical synthesis by procedures well known to the person skilled in the art and such as described in particular below. In the same manner, the labeled or unlabeled mono- or polyclonal antibodies directed against said specific polypeptides encoded by said consensus nucleotide sequences are also part of the invention. It will be possible to use said consensus nucleotide sequences, said corresponding polypeptides as well as said antibodies directed against said polypeptides in procedures or sets for detection and/or identification such as described below, in place of or in addition to nucleotide sequences, polypeptides or antibodies according to the invention, specific to PWD circovirus type A and/or B. These protocols have been improved for the differential detection of the circular monomeric forms of specific replicative forms of the virion or of the DNA in replication and the dimeric forms found in so-called in-tandem molecular constructs. The invention additionally relates to the use of a nucleotide sequence according to the invention as a primer or probe for the detection and/or the amplification of nucleic acid sequences. The nucleotide sequences according to the invention can thus be used to amplify nucleotide sequences, especially by the PCR technique (polymerase chain reaction) (Erlich, 1989; Innis et al., 1990; Rolfs et al., 1991; and White et al., 1997). These oligodeoxyribonucleotide or oligoribonucleotide primers advantageously have a length of at least 8 nucleotides, preferably of at least 12 nucleotides, and even more preferentially at least 20 nucleotides. Other amplification techniques of the target nucleic acid can be advantageously employed as alternatives to PCR. The nucleotide sequences of the invention, in particular the primers according to the invention, can likewise be employed in other procedures of amplification of a target nucleic acid, such as: the TAS technique (Transcription-based Amplification System), described by Kwoh et al. in 1989; the 3SR technique (Self-Sustained Sequence Replication), described by Guatelli et al. in 1990; the NASBA technique (Nucleic Acid Sequence Based Amplification), described by Kievitis et al. in 1991; the SDA technique (Strand Displacement Amplification) (Walker et al., 1992); the TMA technique (Transcription Mediated Amplification). The polynucleotides of the invention can also be employed in techniques of amplification or of modification of the nucleic acid serving as a probe, such as: the LCR technique (Ligase Chain Reaction), described by Landegren et al. in 1988 and improved by Barany et al. in 1991, which employs a thermostable ligase; the RCR technique (Repair Chain Reaction), described by Segev in 1992; the CPR technique (Cycling Probe Reaction), described by Duck et al. in 1990; the amplification technique with Q-beta replicase, described by Miele et al. in 1983 and especially improved by Chu et al. in 1986, Lizardi et al. in 1988, then by Burg et al. as well as by Stone et al. in 1996. In the case where the target polynucleotide to be detected is possibly an RNA, for example an mRNA, it will be possible to use, prior to the employment of an amplification reaction with the aid of at least one primer according to the invention or to the employment of a detection procedure with the aid of at least one probe of the invention, an enzyme of reverse transcriptase type in order to obtain a cDNA from the RNA contained in the biological sample. The cDNA obtained will thus serve as a target for the primer(s) or the probe(s) employed in the amplification or detection procedure according to the invention. The detection probe will be chosen in such a manner that it hybridizes with the target sequence or the amplicon generated from the target sequence. By way of sequence, such a probe will advantageously have a sequence of at least 12 nucleotides, in particular of at least 20 nucleotides, and preferably of at least 100 nucleotides. The invention also comprises the nucleotide sequences utilizable as a probe or primer according to the invention, characterized in that they are labeled with a radioactive compound or with a nonradioactive compound. The unlabeled nucleotide sequences can be used directly as probes or primers, although the sequences are generally labeled with a radioactive element ( 32 P, 35 S, 3 H, 125 I) or with a nonradioactive molecule (biotin, acetylaminofluorene, digoxigenin, 5-bromodeoxyuridine, fluorescein) to obtain probes which are utilizable for numerous applications. Examples of nonradioactive labeling of nucleotide sequences are described, for example, in French Patent No. 78.10975 or by Urdea et al. or by Sanchez-Pescador et al. in 1988. In the latter case, it will also be possible to use one of the labeling methods described in patents FR-2 422 956 and FR-2 518 755. The hybridization technique can be carried out in various manners (Matthews et al., 1988). The most general method consists in immobilizing the nucleic acid extract of cells on a support (such as nitrocellulose, nylon, polystyrene) and in incubating, under well-defined conditions, the immobilized target nucleic acid with the probe. After hybridization, the excess of probe is eliminated and the hybrid molecules formed are detected by the appropriate method (measurement of the radioactivity, of the fluorescence or of the enzymatic activity linked to the probe). The invention likewise comprises the nucleotide sequences according to the invention, characterized in that they are immobilized on a support, covalently or noncovalently. According to another advantageous mode of employing nucleotide sequences according to the invention, the latter can be used immobilized on a support and can thus serve to capture, by specific hybridization, the target nucleic acid obtained from the biological sample to be tested. If necessary, the solid support is separated from the sample and the hybridization complex formed between said capture probe and the target nucleic acid is then detected with the aid of a second probe, a so-called detection probe, labeled with an easily detectable element. Another subject of the present invention is a vector for the cloning and/or expression of a sequence, characterized in that it contains a nucleotide sequence according to the invention. The vectors according to the invention, characterized in that they contain the elements allowing the expression and/or the secretion of said nucleotide sequences in a determined host cell, are likewise part of the invention. The vector must then contain a promoter, signals of initiation and termination of translation, as well as appropriate regions of regulation of transcription. It must be able to be maintained stably in the host cell and can optionally have particular signals specifying the secretion of the translated protein. These different elements are chosen as a function of the host cell used. To this end, the nucleotide sequences according to the invention can be inserted into autonomous replication vectors within the chosen host, or integrated vectors of the chosen host. Such vectors will be prepared according to the methods currently used by the person skilled in the art, and it will be possible to introduce the clones resulting therefrom into an appropriate host by standard methods, such as, for example, lipofection, electroporation and thermal shock. The vectors according to the invention are, for example, vectors of plasmid or viral origin. A preferred vector for the expression of polypeptides of the invention is baculovirus. The vector pBS KS in which is inserted the in-tandem DNA sequence of the PWD circovirus type A (or DFP) as deposited at the CNCM on 3 Jul. 1997, under the number I-1891, is likewise preferred. These vectors are useful for transforming host cells in order to clone or to express the nucleotide sequences of the invention. The invention likewise comprises the host cells transformed by a vector according to the invention. These cells can be obtained by the introduction into host cells of a nucleotide sequence inserted into a vector such as defined above, then the culturing of said cells under conditions allowing the replication and/or expression of the transfected nucleotide sequence. The host cell can be selected from prokaryotic or eukaryotic systems, such as, for example, bacterial cells (Olins and Lee, 1993), but likewise yeast cells (Buckholz, 1993), as well as animal cells, in particular the cultures of mammalian cells (Edwards and Aruffo, 1993), and especially Chinese hamster ovary (CHO) cells, but likewise the cells of insects in which it is possible to use procedures employing baculoviruses, for example (Luckow, 1993). A preferred host cell for the expression of the proteins of the invention is constituted by sf9 insect cells. A more preferred host cell according to the invention is E. coli , such as deposited at the CNCM on 3 Jul. 1997, under the number I-1891. The invention likewise relates to animals comprising one of said transformed cells according to the invention. The obtainment of transgenic animals according to the invention overexpressing one or more of the genes of PWD circovirus or part of the genes will be preferably carried out in rats, mice or rabbits according to methods well known to the person skilled in the art, such as by viral or nonviral transfections. It will be possible to obtain the transgenic animals overexpressing one or more of said genes by transfection of multiple copies of said genes under the control of a strong promoter of ubiquitous nature, or selective for one type of tissue. It will likewise be possible to obtain the transgenic animals by homologous recombination in embryonic cell strains, transfer of these cell strains to embryos, selection of the affected chimeras at the level of the reproductive lines, and growth of said chimeras. The transformed cells as well as the transgenic animals according to the invention are utilizable in procedures for preparation of recombinant polypeptides. It is today possible to produce recombinant polypeptides in relatively large quantity by genetic engineering using the cells transformed by expression vectors according to the invention or using transgenic animals according to the invention. The procedures for preparation of a polypeptide of the invention in recombinant form, characterized in that they employ a vector and/or a cell transformed by a vector according to the invention and/or a transgenic animal comprising one of said transformed cells according to the invention, are themselves comprised in the present invention. Among said procedures for preparation of a polypeptide of the invention in recombinant form, the preparation procedures employing a vector, and/or a cell transformed by said vector and/or a transgenic animal comprising one of said transformed cells, containing a nucleotide sequence according to the invention coding for a polypeptide of PWD circovirus, are preferred. The recombinant polypeptides obtained as indicated above can just as well be present in glycosylated form as in nonglycosylated form and can or cannot have the natural tertiary structure. A preferred variant consists in producing a recombinant polypeptide used to a “carrier” protein (chimeric protein). The advantage of this system is that it allows a stabilization of and a decrease in the proteolysis of the recombinant product, an increase in the solubility in the course of renaturation in vitro and/or a simplification of the purification when the fusion partner has an affinity for a specific ligand. More particularly, the invention relates to a procedure for preparation of a polypeptide of the invention comprising the following steps: a) culture of transformed cells under conditions allowing the expression of a recombinant polypeptide of nucleotide sequence according to the invention; b) if need be, recovery of said recombinant polypeptide. When the procedure for preparation of a polypeptide of the invention employs a transgenic animal according to the invention, the recombinant polypeptide is then extracted from said animal. The invention also relates to a polypeptide which is capable of being obtained by a procedure of the invention such as described previously. The invention also comprises a procedure for preparation of a synthetic polypeptide, characterized in that it uses a sequence of amino acids of polypeptides according to the invention. The invention likewise relates to a synthetic polypeptide obtained by a procedure according to the invention. The polypeptides according to the invention can likewise be prepared by techniques which are conventional in the field of the synthesis of peptides. This synthesis can be carried out in homogeneous solution or in solid phase. For example, recourse can be made to the technique of synthesis in homogeneous solution described by Houben-Weyl in 1974. This method of synthesis consists in successively condensing, two by two, the successive amino acids in the order required, or in condensing amino acids and fragments formed previously and already containing several amino acids in the appropriate order, or alternatively several fragments previously prepared in this way, it being understood that it will be necessary to protect beforehand all the reactive functions carried by these amino acids or fragments, with the exception of amine functions of one and carboxyls of the other or vice-versa, which must normally be involved in the formation of peptide bonds, especially after activation of the carboxyl function, according to the methods well known in the synthesis of peptides. According to another preferred technique of the invention, recourse will be made to the technique described by Merrifield. To make a peptide chain according to the Merrifield procedure, recourse is made to a very porous polymeric resin, on which is immobilized the first C-terminal amino acid of the chain. This amino acid is immobilized on a resin through its carboxyl group and its amine function is protected. The amino acids which are going to form the peptide chain are thus immobilized, one after the other, on the amino group, which is deprotected beforehand each time, of the portion of the peptide chain already formed, and which is attached to the resin. When the whole of the desired peptide chain has been formed, the protective groups of the different amino acids forming the peptide chain are eliminated and the peptide is detached from the resin with the aid of an acid. The invention additionally relates to hybrid polypeptides having at least one polypeptide according to the invention, and a sequence of a polypeptide capable of inducing an immune response in man or animals. Advantageously, the antigenic determinant is such that it is capable of inducing a humoral and/or cellular response. It will be possible for such a determinant to comprise a polypeptide according to the invention in glycosylated form used with a view to obtaining immunogenic compositions capable of inducing the synthesis of antibodies directed against multiple epitopes. Said polypeptides or their glycosylated fragments are likewise part of the invention. These hybrid molecules can be formed, in part, of a polypeptide carrier molecule or of fragments thereof according to the invention, associated with a possibly immunogenic part, in particular an epitope of the diphtheria toxin, the tetanus toxin, a surface antigen of the hepatitis B virus (patent FR 79 21811), the VP1 antigen of the poliomyelitis virus or any other viral or bacterial toxin or antigen. The procedures for synthesis of hybrid molecules encompass the methods used in genetic engineering for constructing hybrid nucleotide sequences coding for the polypeptide sequences sought. It will be possible, for example, to refer advantageously to the technique for obtainment of genes coding for fusion proteins described by Minton in 1984. Said hybrid nucleotide sequences coding for a hybrid polypeptide as well as the hybrid polypeptides according to the invention characterized in that they are recombinant polypeptides obtained by the expression of said hybrid nucleotide sequences are likewise part of the invention. The invention likewise comprises the vectors characterized in that they contain one of said hybrid nucleotide sequences. The host cells transformed by said vectors, the transgenic animals comprising one of said transformed cells as well as the procedures for preparation of recombinant polypeptides using said vectors, said transformed cells and/or said transgenic animals are, of course, likewise part of the invention. The polypeptides according to the invention, the antibodies according to the invention described below and the nucleotide sequences according to the invention can advantageously be employed in procedures for the detection and/or identification of PWD circovirus, or of porcine circovirus other than a PWD circovirus, in a biological sample (biological tissue or fluid) capable of containing them. These procedures, according to the specificity of the polypeptides, the antibodies and the nucleotide sequences according to the invention which will be used, will in particular be able to detect and/or to identify a PWD circovirus or a porcine circovirus other than a PWD circovirus or other than the PWD circovirus of type B. The polypeptides according to the invention can advantageously be employed in a procedure for the detection and/or the identification of PWD circovirus of type A, of type B, of type A or B, or porcine circovirus other than the PWD circovirus of type B, or of porcine circovirus other than the PWD circovirus of type A or B, in a biological sample (biological tissue or fluid) capable of containing them, characterized in that it comprises the following steps: a) contacting of this biological sample with a polypeptide or one of its fragments according to the invention (under conditions allowing an immunological reaction between said polypeptide and the antibodies possibly present in the biological sample); b) demonstration of the antigen-antibody complexes possibly formed. In the present description, PWD circovirus, except if a particular mention is indicated, will be understood as designating a PWD circovirus of type A or of type B, and porcine circovirus other than PWD, except if a particular mention is indicated, will be understood as designating a porcine circovirus other than a PWD circovirus of type A and B. Preferably, the biological sample is formed by a fluid, for example a pig serum, whole blood or biopsies. Any conventional procedure can be employed for carrying out such a detection of the antigen-antibody complexes possibly formed. By way of example, a preferred method brings into play immunoenzymatic processes according to the ELISA technique, by immunofluorescence, or radioimmunological processes (RIA) or their equivalent. Thus, the invention likewise relates to the polypeptides according to the invention, labeled with the aid of an adequate label such as of the enzymatic, fluorescent or radioactive type. Such methods comprise, for example, the following steps: deposition of determined quantities of a polypeptide composition according to the invention in the wells of a microtiter plate, introduction into said wells of increasing dilutions of serum, or of a biological sample other than that defined previously, having to be analyzed, incubation of the microplate, introduction into the wells of the microtiter plate of labeled antibodies directed against pig immunoglobulins, the labeling of these antibodies having been carried out with the aid of an enzyme selected from those which are capable of hydrolyzing a substrate by modifying the absorption of the radiation of the latter, at least at a determined wavelength, for example at 550 nm, detection, by comparison with a control test, of the quantity of hydrolyzed substrate. The invention likewise relates to a kit or set for the detection and/or identification of PWD circovirus, of porcine circovirus other than a PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, characterized in that it comprises the following elements: a polypeptide according to the invention, if need be, the reagents for the formation of the medium favorable to the immunological or specific reaction, if need be, the reagents allowing the detection of the antigen-antibody complexes produced by the immunological reaction between the polypeptide(s) of the invention and the antibodies possibly present in the biological sample, these reagents likewise being able to carry a label, or to be recognized in their turn by a labeled reagent, more particularly in the case where the polypeptide according to the invention is not labeled, if need be, a biological reference sample (negative control) devoid of antibodies recognized by a polypeptide according to the invention, if need be, a biological reference sample (positive control) containing a predetermined quantity of antibodies recognized by a polypeptide according to the invention. The polypeptides according to the invention allow monoclonal or polyclonal antibodies to be prepared which are characterized in that they specifically recognize the polypeptides according to the invention. It will advantageously be possible to prepare the monoclonal antibodies from hybridomas according to the technique described by Kohler and Milstein in 1975. It will be possible to prepare the polyclonal antibodies, for example, by immunization of an animal, in particular a mouse, with a polypeptide or a DNA, according to the invention, associated with an adjuvant of the immune response, and then purification of the specific antibodies contained in the serum of the immunized animals on an affinity column on which the polypeptide which has served as an antigen has previously been immobilized. The polyclonal antibodies according to the invention can also be prepared by purification, on an affinity column on which a polypeptide according to the invention has previously been immobilized, of the antibodies contained in the serum of pigs infected by a PWD circovirus. The invention likewise relates to mono- or polyclonal antibodies or their fragments, or chimeric antibodies, characterized in that they are capable of specifically recognizing a polypeptide according to the invention. It will likewise be possible for the antibodies of the invention to be labeled in the same manner as described previously for the nucleic probes of the invention, such as a labeling of enzymatic, fluorescent or radioactive type. The invention is additionally directed at a procedure for the detection and/or identification of PWD circovirus, of porcine circovirus other than a PWD circovirus, or other than the PWD circovirus of type B, in a biological sample, characterized in that it comprises the following steps: a) contacting of the biological sample (biological tissue or fluid) with a mono- or polyclonal antibody according to the invention (under conditions allowing an immunological reaction between said antibodies and the polypeptides of PWD circovirus, of porcine circovirus other than a PWD circovirus, of porcine circovirus other than the PWD circovirus of type B, possibly present in the biological sample); b) demonstration of the antigen-antibody complex possibly formed. Likewise within the scope of the invention is a kit or set for the detection and/or the identification of PWD circovirus, of porcine circovirus other than a PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, characterized in that it comprises the following components: a polyclonal or monoclonal antibody according to the invention, if need be labeled; if need be, a reagent for the formation of the medium favorable to the carrying out of the immunological reaction; if need be, a reagent allowing the detection of the antigen-antibody complexes produced by the immunological reaction, this reagent likewise being able to carry a label, or being capable of being recognized in its turn by a labeled reagent, more particularly in the case where said monoclonal or polyclonal antibody is not labeled; if need be, reagents for carrying out the lysis of cells of the sample tested. The present invention likewise relates to a procedure for the detection and/or the identification of PWD, of porcine circovirus other than a PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, in a biological sample, characterized in that it employs a nucleotide sequence according to the invention. More particularly, the invention relates to a procedure for the detection and/or the identification of PWD circovirus, of porcine circovirus other than a PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, in a biological sample, characterized in that it contains the following steps: a) if need be, isolation of the DNA from the biological sample to be analyzed; b) specific amplification of the DNA of the sample with the aid of at least one primer, or a pair of primers, according to the invention; c) demonstration of the amplification products. These can be detected, for example, by the technique of molecular hybridization utilizing a nucleic probe according to the invention. This probe will advantageously be labeled with a nonradioactive (cold probe) or radioactive element. For the purposes of the present invention, “DNA of the biological sample” or “DNA contained in the biological sample” will be understood as meaning either the DNA present in the biological sample considered, or possibly the cDNA obtained after the action of an enzyme of reverse transcriptase type on the RNA present in said biological sample. Another aim of the present invention consists in a procedure according to the invention, characterized in that it comprises the following steps: a) contacting of a nucleotide probe according to the invention with a biological sample, the DNA contained in the biological sample having, if need be, previously been made accessible to hybridization under conditions allowing the hybridization of the probe with the DNA of the sample; b) demonstration of the hybrid formed between the nucleotide probe and the DNA of the biological sample. The present invention also relates to a procedure according to the invention, characterized in that it comprises the following steps: a) contacting of a nucleotide probe immobilized on a support according to the invention with a biological sample, the DNA of the sample having, if need be, previously been made accessible to hybridization, under conditions allowing the hybridization of the probe with the DNA of the sample; b) contacting of the hybrid formed between the nucleotide probe immobilized on a support and the DNA contained in the biological sample, if need be after elimination of the DNA of the biological sample which has not hybridized with the probe, with a nucleotide probe labeled according to the invention; c) demonstration of the novel hybrid formed in step b). According to an advantageous embodiment of the procedure for detection and/or identification defined previously, this is characterized in that, prior to step a), the DNA of the biological sample is first amplified with the aid of at least one primer according to the invention. The invention is additionally directed at a kit or set for the detection and/or the identification of PWD circovirus, of porcine circovirus other than the PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, characterized in that it comprises the following elements: a) a nucleotide probe according to the invention; b) if need be, the reagents necessary for the carrying out of a hybridization reaction; c) if need be, at least one primer according to the invention as well as the reagents necessary for an amplification reaction of the DNA. The invention likewise relates to a kit or set for the detection and/or the identification of PWD circovirus, of porcine circovirus other than a PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, characterized in that it comprises the following components: a) a nucleotide probe, called a capture probe, according to the invention; b) an oligonucleotide probe, called a revealing probe, according to the invention, c) if need be, at least one primer according to the invention, as well as the reagents necessary for an amplification reaction of the DNA. The invention also relates to a kit or set for the detection and/or identification of PWD circovirus, of porcine circovirus other than a PWD circovirus or of porcine circovirus other than the PWD circovirus of type B, characterized in that it comprises the following elements: a) at least one primer according to the invention; b) if need be, the reagents necessary for carrying out a DNA amplification reaction; c) if need be, a component allowing the sequence of the amplified fragment to be verified, more particularly an oligonucleotide probe according to the invention. The invention additionally relates to the use of a nucleotide sequence according to the invention, of a polypeptide according to the invention, of an antibody according to the invention, of a cell according to the invention, and/or of an animal transformed according to the invention, for the selection of an organic or inorganic compound capable of modulating, inducing or inhibiting the expression of genes, and/or of modifying the cellular replication of PWD circovirus or capable of inducing or of inhibiting the pathologies linked to an infection by a PWD circovirus. The invention likewise comprises a method of selection of compounds capable of binding to a polypeptide or one of its fragments according to the invention, capable of binding to a nucleotide sequence according to the invention, or capable of recognizing an antibody according to the invention, and/or capable of modulating, inducing or inhibiting the expression of genes, and/or of modifying the cellular replication of PWD circovirus or capable of inducing or inhibiting the pathologies linked to an infection by a PWD circovirus, characterized in that it comprises the following steps: a) contacting of said compound with said polypeptide, said nucleotide sequence, or with a cell transformed according to the invention and/or administration of said compound to an animal transformed according to the invention; b) determination of the capacity of said compound to bind to said polypeptide or said nucleotide sequence, or to modulate, induce or inhibit the expression of genes, or to modulate the growth or the replication of PWD circovirus, or to induce or inhibit in said transformed animal the pathologies linked to an infection by PWD circovirus (designated activity of said compound). The compounds capable of being selected can be organic compounds such as polypeptides or carbohydrates or any other organic or inorganic compounds already known, or novel organic compounds elaborated by molecular modelling techniques and obtained by chemical or biochemical synthesis, these techniques being known to the person skilled in the art. It will be possible to use said selected compounds to modulate the cellular replication of PWD circovirus and thus to control infection by this virus, the methods allowing said modulations to be determined being well known to the person skilled in the art. This modulation can be carried out, for example, by an agent capable of binding to a protein and thus of inhibiting or of potentiating its biological activity, or capable of binding to an envelope protein of the external surface of said virus and of blocking the penetration of said virus into the host cell or of favoring the action of the immune system of the infected organism directed against said virus. This modulation can likewise be carried out by an agent capable of binding to a nucleotide sequence of a DNA of said virus and of blocking, for example, the expression of a polypeptide whose biological or structural activity is necessary for the replication or for the proliferation of said virus host cells to host cells in the host animal. The invention relates to the compounds capable of being selected by a selection method according to the invention. The invention likewise relates to a pharmaceutical composition comprising a compound selected from the following compounds: a) a nucleotide sequence according to the invention; b) a polypeptide according to the invention; c) a vector, a viral particle or a cell transformed according to the invention; d) an antibody according to the invention; e) a compound capable of being selected by a selection method according to the invention; possibly in combination with a pharmaceutically acceptable vehicle and, if need be, with one or more adjuvants of the appropriate immunity. The invention also relates to an immunogenic and/or vaccine composition, characterized in that it comprises a compound selected from the following compounds: a) a nucleotide sequence according to the invention; b) a polypeptide according to the invention; c) a vector or a viral particle according to the invention; and d) a cell according to the invention. In one embodiment, the vaccine composition according to the invention is characterized in that it comprises a mixture of at least two of said compounds a), b), c) and d) above and in that one of the two said compounds is related to the PWD circovirus of type A and the other is related to the PWD circovirus of type B. In another embodiment of the invention, the vaccine composition is characterized in that it comprises at least one compound a), b), c), or d) above which is related to PWD circovirus of type B. In still another embodiment, the vaccine composition is characterized in that it comprises at least one compound a), b), c), or d) above which is related to PWD circovirus of type B ORF′2. A compound related to the PWD circovirus of type A or of type B is understood here as respectively designating a compound obtained from the genomic sequence of the PWD circovirus of type A or of type B. The invention is additionally aimed at an immunogenic and/or vaccine composition, characterized in that it comprises at least one of the following compounds: a nucleotide sequence SEQ ID No. 23, SEQ ID No. 25, or one of their fragments or homologues; a polypeptide of sequence SEQ ID No. 24, SEQ ID No. 26, or one of their fragments, or a modification thereof; a vector or a viral particle comprising a nucleotide sequence SEQ ID No. 23, SEQ ID No. 25, or one of their fragments or homologues; a transformed cell capable of expressing a polypeptide of sequence SEQ ID No. 24, SEQ ID No. 26, or one of their fragments, or a modification thereof; or a mixture of at least two of said compounds. The invention also comprises an immunogenic and/or vaccine composition according to the invention, characterized in that it comprises said mixture of at least two of said compounds as a combination product for simultaneous, separate or protracted use for the prevention or the treatment of infection by a PWD circovirus, especially of type B. In a preferred embodiment, the vaccine composition according to the invention comprises the mixture of the following compounds: a pcDNA3 plasmid containing a nucleic acid of sequence SEQ ID No. 23; a pcDNA3 plasmid containing a nucleic acid of sequence SEQ ID No. 25; a pcDNA3 plasmid containing a nucleic acid coding for the GM-CSF protein; a recombinant baculovirus containing a nucleic acid of sequence SEQ ID No. 23; a recombinant baculovirus containing a nucleic acid of sequence SEQ ID No. 25; and if need be, an adjuvant of the appropriate immunity, especially the adjuvant AIF™. The invention is likewise directed at a pharmaceutical composition according to the invention, for the prevention or the treatment of an infection by a PWD circovirus. The invention is also directed at a pharmaceutical composition according to the invention for the prevention or the treatment of an infection by the PWD circovirus of type B. The invention likewise concerns the use of a composition according to the invention, for the preparation of a medicament intended for the prevention or the treatment of infection by a PWD circovirus, preferably by the PWD circovirus of type B. Under another aspect, the invention relates to a vector, a viral particle or a cell according to the invention, for the treatment and/or the prevention of a disease by gene therapy. Finally, the invention comprises the use of a vector, of a viral particle or of a cell according to the invention for the preparation of a medicament intended for the treatment and/or the prevention of a disease by gene therapy. The polypeptides of the invention entering into the immunogenic or vaccine compositions according to the invention can be selected by techniques known to the person skilled in the art such as, for example, depending on the capacity of said polypeptides to stimulate the T cells, which is translated, for example, by their proliferation or the secretion of interleukins, and which leads to the production of antibodies directed against said polypeptides. In pigs, as in mice, in which a weight dose of the vaccine composition comparable to the dose used in man is administered, the antibody reaction is tested by taking of the serum followed by a study of the formation of a complex between the antibodies present in the serum and the antigen of the vaccine composition, according to the usual techniques. The pharmaceutical compositions according to the invention will contain an effective quantity of the compounds of the invention, that is to say in sufficient quantity of said compound(s) allowing the desired effect to be obtained, such as, for example, the modulation of the cellular replication of PWD circovirus. The person skilled in the art will know how to determine this quantity, as a function, for example, of the age and of the weight of the individual to be treated, of the state of advancement of the pathology, of the possible secondary effects and by means of a test of evaluation of the effects obtained on a population range, these tests being known in these fields of application. According to the invention, said vaccine combinations will preferably be combined with a pharmaceutically acceptable vehicle and, if need be, with one or more adjuvants of the appropriate immunity. Today, various types of vaccines are available for protecting animals or man against infectious diseases: attenuated living microorganisms ( M. bovis —BCG for tuberculosis), inactivated microorganisms (influenza virus), acellular extracts ( Bordetella pertussis for whooping cough), recombined proteins (surface antigen of the hepatitis B virus), polysaccharides (pneumococcal). Vaccines prepared from synthetic peptides or genetically modified microorganisms expressing heterologous antigens are in the course of experimentation. More recently still, recombined plasmid DNAs carrying genes coding for protective antigens have been proposed as an alternative vaccine strategy. This type of vaccination is carried out with a particular plasmid originating from a plasmid of E. coli which does not replicate in vivo and which codes uniquely for the vaccinating protein. Animals have been immunized by simply injecting the naked plasmid DNA into the muscle. This technique leads to the expression of the vaccine protein in situ and to an immune response of cellular type (CTL) and of humoral type (antibody). This double induction of the immune response is one of the principal advantages of the vaccination technique with naked DNA. The vaccine compositions comprising nucleotide sequences or vectors into which are inserted said sequences are especially described in the international application No. WO 90/11092 and likewise in the international application No. WO 95/11307. The constitutive nucleotide sequence of the vaccine composition according to the invention can be injected into the host after having been coupled to compounds which favor the penetration of this polynucleotide into the interior of the cell or its transport to the cell nucleus. The resultant conjugates can be encapsulated in polymeric microparticles, as described in the international application No. WO 94/27238 (Medisorb Technologies International). According to another embodiment of the vaccine composition according to the invention, the nucleotide sequence, preferably a DNA, is complexed with DEAE-dextran (Pagano et al., 1967) or with nuclear proteins (Kaneda et al., 1989), with lipids (Felgner et al., 1987) or encapsulated in liposomes (Fraley et al., 1980) or else introduced in the form of a gel facilitating its transfection into the cells (Midoux et al., 1993, Pastore et al., 1994). The polynucleotide or the vector according to the invention can also be in suspension in a buffer solution or be combined with liposomes. Advantageously, such a vaccine will be prepared according to the technique described by Tacson et al. or Huygen et al. in 1996 or alternatively according to the technique described by Davis et al. in the international application No. WO 95/11307. Such a vaccine can likewise be prepared in the form of a composition containing a vector according to the invention, placed under the control of regulation elements allowing its expression in man or animal. It will be possible, for example, to use, by way of in vivo expression vector of the polypeptide antigen of interest, the plasmid pcDNA3 or the plasmid pcDNA1/neo, both marketed by Invitrogen (R&D Systems, Abingdon, United Kingdom). It is also possible to use the plasmid V1Jns.tPA, described by Shiver et al. in 1995. Such a vaccine will advantageously comprise, apart from the recombinant vector, a saline solution, for example a sodium chloride solution. Pharmaceutically acceptable vehicle is understood as designating a compound or a combination of compounds entering into a pharmaceutical composition or vaccine which does not provoke secondary reactions and which allows, for example, the facilitation of the administration of the active compound, an increase in its duration of life and/or its efficacy in the body, an increase in its solubility in solution or alternatively an improvement in its conservation. These pharmaceutically acceptable vehicles are well known and will be adapted by the person skilled in the art as a function of the nature and of the mode of administration of the chosen active compound. As far as the vaccine formulations are concerned, these can comprise adjuvants of the appropriate immunity which are known to the person skilled in the art, such as, for example, aluminum hydroxide, a representative of the family of muramyl peptides such as one of the peptide derivatives of N-acetyl muramyl, a bacterial lysate, or alternatively Freund's incomplete adjuvant. These compounds can be administered by the systemic route, in particular by the intravenous route, by the intramuscular, intradermal or subcutaneous route, or by the oral route. In a more preferred manner, the vaccine composition comprising polypeptides according to the invention will be administered by the intramuscular route, through the food or by nebulization several times, staggered over time. Their administration modes, dosages and optimum pharmaceutical forms can be determined according to the criteria generally taken into account in the establishment of a treatment adapted to an animal such as, for example, the age or the weight, the seriousness of its general condition, the tolerance to the treatment and the secondary effects noted. Preferably, the vaccine of the present invention is administered in an amount that is protective against piglet weight loss disease. For example, in the case of a vaccine according to the present invention comprising a polypeptide encoded by a nucleotide sequence of the genome of PCV, or a homologue or fragment thereof, the polypeptide will be administered one time or several times, spread out over time, directly or by means of a transformed cell capable of expressing the polypeptide, in an amount of about 0.1 to 10 μg per kilogram weight of the animal, preferrably about 0.2 to about 5 μg/kg, more preferably about 0.5 to about 2 μg/kg for a dose. The present invention likewise relates to the use of nucleotide sequences of PWD circovirus according to the invention for the construction of autoreplicative retroviral vectors and the therapeutic applications of these, especially in the field of human gene therapy in vivo. The feasibility of gene therapy applied to man no longer needs to be demonstrated and this relates to numerous therapeutic applications like genetic diseases, infectious diseases and cancers. Numerous documents of the prior art describe the means of employing gene therapy, especially through viral vectors. Generally speaking, the vectors are obtained by deletion of at least some of the viral genes which are replaced by the genes of therapeutic interest. Such vectors can be propagated in a complementation line which supplies in trans the deleted viral functions in order to generate a defective viral vector particle for replication but capable of infecting a host cell. To date, the retroviral vectors are amongst the most widely used and their mode of infection is widely described in the literature accessible to the person skilled in the art. The principle of gene therapy is to deliver a functional gene, called a gene of interest, of which the RNA or the corresponding protein will produce the desired biochemical effect in the targeted cells or tissues. On the one hand, the insertion of genes allows the prolonged expression of complex and unstable molecules such as RNAs or proteins which can be extremely difficult or even impossible to obtain or to administer directly. On the other hand, the controlled insertion of the desired gene into the interior of targeted specific cells allows the expression product to be regulated in defined tissues. For this, it is necessary to be able to insert the desired therapeutic gene into the interior of chosen cells and thus to have available a method of insertion capable of specifically targeting the cells or the tissues chosen. Among the methods of insertion of genes, such as, for example, microinjection, especially the injection of naked plasmid DNA (Derse, D. et al., 1995, and Zhao, T. M. et al., 1996), electroporation, homologous recombination, the use of viral particles, such as retroviruses, is widespread. However, applied in vivo, the gene transfer systems of recombinant retroviral type at the same time have a weak infectious power (insufficient concentration of viral particles) and a lack of specificity with regard to chosen target cells. The production of cell-specific viral vectors, having a tissue-specific tropism, and whose gene of interest can be translated adequately by the target cells, is realizable, for example, by fusing a specific ligand of the target host cells to the N-terminal part of a surface protein of the envelope of PWD circovirus. It is possible to mention, for example, the construction of retroviral particles having the CD4 molecule on the surface of the envelope so as to target the human cells infected by the HIV virus (YOUNG, J. A. T. et al., Sciences 1990, 250, 1421-1423), viral particles having a peptide hormone fused to an envelope protein to specifically infect the cells expressing the corresponding receptor (KASAHARA, N. et al., Sciences 1994, 266, 1373-1376) or else alternatively viral particles having a fused polypeptide capable of immobilizing on the receptor of the epidermal growth factor (EGF) (COSSET, F. L. et al., J. of Virology 1995, 69, 10, 6314-6322). In another approach, single-chain fragments of antibodies directed against surface antigens of the target cells are inserted by fusion with the N-terminal part of the envelope protein (VALSESIA-WITTMAN, S. et al., J. of Virology 1996, 70, 3, 2059-2064; TEARINA CHU, T. H. et al., J. of Virology 1997, 71, 1, 720-725). For the purposes of the present invention, a gene of interest in use in the invention can be obtained from a eukaryotic or prokaryotic organism or from a virus by any conventional technique. It is, preferably, capable of producing an expression product having a therapeutic effect and it can be a product homologous to the cell host or, alternatively, heterologous. In the scope of the present invention, a gene of interest can code for an (i) intracellular or (ii) membrane product present on the surface of the host cell or (iii) secreted outside the host cell. It can therefore comprise appropriate additional elements such as, for example, a sequence coding for a secretion signal. These signals are known to the person skilled in the art. In accordance with the aims pursued by the present invention, a gene of interest can code for a protein corresponding to all or part of a native protein as found in nature. It can likewise be a chimeric protein, for example arising from the fusion of polypeptides of various origins or from a mutant having improved and/or modified biological properties. Such a mutant can be obtained, by conventional biological techniques, by substitution, deletion and/or addition of one or more amino acid residues. It is very particularly preferred to employ a gene of therapeutic interest coding for an expression product capable of inhibiting or retarding the establishment and/or the development of a genetic or acquired disease. A vector according to the invention is in particular intended for the prevention or for the treatment of cystic fibrosis, of hemophilia A or B, of Duchenne's or Becker's myopathy, of cancer, of AIDS and of other bacteria or infectious diseases due to a pathogenic organism: virus, bacteria, parasite or prion. The genes of interest utilizable in the present invention are those which code, for example, for the following proteins: a cytokine and especially an interleukin, an interferon, a tissue necrosis factor and a growth factor and especially a hematopoietic growth factor (G-CSF, GM-CSF), a factor or cofactor involved in clotting and especially factor VIII, von Willebrand's factor, antithrombin III, protein C, thrombin and hirudin, an enzyme or an enzyme inhibitor such as the inhibitors of viral proteases, an expression product of a suicide gene such as thymidine kinase of the HSV virus (herpesvirus) of type 1, an activator or an inhibitor of ion channels, a protein of which the absence, the modification or the deregulation of expression is responsible for a genetic disease, such as the CFTR protein, dystrophin or minidystrophin, insulin, ADA (adenosine diaminose), glucocerebrosidase and phenylhydroxylase, a protein capable of inhibiting the initiation or the progression of cancers, such as the expression products of tumor suppressor genes, for example the P53 and Rb genes, a protein capable of stimulating an immune or an antibody response, and a protein capable of inhibiting a viral infection or its development, for example the antigenic epitopes of the virus in question or altered variants of viral proteins capable of entering into competition with the native viral proteins. The invention thus relates to the vectors characterized in that they comprise a nucleotide sequence of PWD circovirus according to the invention, and in that they additionally comprise a gene of interest. The present invention likewise relates to viral particles generated from said vector according to the invention. It additionally relates to methods for the preparation of viral particles according to the invention, characterized in that they employ a vector according to the invention, including viral pseudoparticles (VLP, virus-like particles). The invention likewise relates to animal cells transfected by a vector according to the invention. Likewise comprised in the invention are animal cells, especially mammalian, infected by a viral particle according to the invention. The present invention likewise relates to a vector, a viral particle or a cell according to the invention, for the treatment and/or the prevention of a genetic disease or of an acquired disease such as cancer or an infectious disease. The invention is likewise directed at a pharmaceutical composition comprising, by way of therapeutic or prophylactic agent, a vector or a cell according to the invention, in combination with a vehicle acceptable from a pharmaceutical point of view. Other characteristics and advantages of the invention appear in the examples and the figures. The invention is described in more detail in the following illustrative examples. Although the examples may represent only selected embodiments of the invention, it should be understood that the following examples are illustrative and not limiting. EXAMPLES Example 1 Cloning, Sequencing and Characterization of the PWD Circovirus of Type A (PCVA) 1. Experimental Procedures Experimental reproduction of the infection and its syndrome (cf. FIG. 1 ). A first test was carried out with pigs from a very well-kept farm, but affected by piglet weight loss disease (PWD), likewise called fatal piglet wasting (FPW). Tests carried out with SPF (specific pathogen-free) pigs showed a transfer of contaminant(s) finding expression in a complex pathology combining hyperthermia, retardation of growth, diarrhea and conjunctivitis. The PDRS (porcine dysgenic and respiratory syndrome) virus, an infectious disease due to an arteriovirus) was rapidly isolated from breeding pigs and contact pigs. It should have been possible to attribute all the clinical signs to the presence of the PDRS virus. However, two farm pigs presented signs of FPW without the PDRS virus being isolated. The histological analyses and blood formulas, however, showed that these pigs were suffering from an infectious process of viral origin. In a second test, 8-week SPF pigs were inoculated by the intratracheal route with organ homogenates of two farm pigs suffering from FPW. The inoculated pigs exhibited hyperthermia 8 to 9 days post-infection, then their growth was retarded. Other SPF pigs, placed in contact, had similar, attenuated signs 30 days after the initial experiment. No seroconversion with respect to a European or Canadian strain of PDRS virus was recorded in these animals. A third test allowed the syndrome to be reproduced from samples taken from the pigs of the second test. Conclusion The syndrome is reproduced under the experimental conditions. It is determined by at least one infectious agent, which is transmittable by direct contact. The clinical constants are a sometimes high hyperthermia (greater than or equal to 41.5° C.) which develops 8 to 10 days after infection. Retardation of the growth can be observed. The other signs are a reversal of the blood formula (reversal of the lymphocyte/polynuclear ratio from 70/30 to 30/70) and frequent lesions on the ganglia, especially those draining the respiratory apparatus (ganglionic hypertrophy, loss of structure with necrosis and infiltration by mononucleated or plurinucleated giant cells). 2. Laboratory Studies Various cell supports including primary pig kidney cells or cell lines, pig testicle cells, monkey kidney cells, pig lymphocytes, pig alveolar macrophages and circulating blood monocytes were used to demonstrate the possible presence of a virus. No cytopathic effect was demonstrated in these cells. On the other hand, the use of a serum of a pig sick after experimental infection allowed an intracellular antigen to be revealed in the monocytes, the macrophages and approximately 10% of pig kidney (PK) cells infected with organ homogenates. This indirect revealing was carried out kinetically at different culture times. It is evident from this that the antigen initially appears in the nucleus of the infected cells before spreading into the cytoplasm. The successive passages in cell culture did not allow the signal to be amplified. Under electron microscopy on organ homogenates, spherical particles labeled specifically by the serum of sick pigs, infected under the experimental conditions, were visualized. The size of these particles is estimated at 20 nm. After two passages of these organ homogenates over pig lymphocytes and then three passages over pig kidney or testicle cells, a cytopathic effect developed and was amplified. An adenovirus was visualized in the electron microscope, which, under the experimental conditions, did not reproduce FPW (only a hyperthermia peak was noted 24 to 48 hours after infection, and then nothing more). It has been possible to demonstrate DNA bands in certain samples of pigs infected under the experimental conditions and having exhibited signs of the disease (results not shown). A certain connection exists between the samples giving a positive result in cell culture and those having a DNA band. Conclusion At least two types of virus were demonstrated in the organ homogenates from pigs suffering from FPW. One is an adenovirus, but by itself alone it does not reproduce the disease. The other type of virus is a circovirus and is associated with FPW. This circovirus, of which two types have been isolated and sequenced, designated below PWD circovirus type A (or PCVA) and PWD circovirus of type B (or PCVB) have mutations with respect to the known sequences of circovirus which are nonpathogenic for the pig. 3. Cloning and Sequencing of the DNA of the PWD Circovirus of Type A Extraction of the replicative form (RF) DNA, cleavage by the Kpn I enzyme and amplification by a pair of primers flanking the Kpn I restriction site. Sequencing of the two strands at least twice by the Sanger method. The nucleic sequence of the strand of (+) polarity of the genome of the PWD circovirus of type A (or PCVA), strain FPW, is represented by the sequence SEQ ID No. 1 in the list of sequences, the nucleic sequence of the strand of (−) polarity of the genome of the PWD circovirus of type A (or PCVA) being represented by the nucleic sequence 3′→5′ of FIG. 3 or by the sequence SEQ ID No. 5 (represented according to the orientation 5′→3′) in the list of sequences. The amino acid sequences SEQ ID No. 10, SEQ ID No. 12 and SEQ ID No. 14 of the list of sequences respectively represent the sequences of proteins encoded by the nucleic sequences of the 3 open reading frames SEQ ID No. 9 (ORF1), corresponding to the REP protein, SEQ ID No. 11 (ORF2) and SEQ ID No. 13 (ORF3), determined from the sequence SEQ ID No. 1 of the strand of (+) polarity or of the nucleic sequence SEQ ID No. 5 of the strand of (−) polarity of the genome of the PWD circovirus of type A. 4. Comparison of the Nucleotide Sequences and Amino Acids of the PWD Circovirus of Type A (or Associated with PWD) which are Obtained with the Corresponding Sequences of MEEHAN and MANKERTZ Circoviruses of Porcine Cell Lines Use of the DNA sequence analysis software, DNASIS. Sequences of Oligonucleotides used as Primers or Probes in the Detection and/or Identification Procedures 1. Specific detection of the PWD circovirus of type A: SEQ ID No.46 primer PCV 5:  5′ GTG TGC TCG ACA TTG GTG TG 3′; SEQ ID No.47 primer PCV 10: 5′ TGG AAT GTT AAC GAG CTG AG 3′; 2. Specific detection of the circovirus of the cell lines: SEQ ID No.46 primer PCF 5: 5′ GTG TGC TCG ACA TTG GTG TG 3′; SEQ ID No.52 primer MEE 1: 5′ TGG AAT GTT AAC TAC CTC AA 3′; 3. Differential detection: the pairs of primers used are those described, for example, in the paragraphs 1 and 2 above; 4. Detection of the monomeric circular replicative forms RF: SEQ ID No.46 primer PCV 5: 5′ GTG TGC TCG ACA TTG GTG TG 3′; SEQ ID No.48 primer PCV 6: 5′ CTC GCA GCC ATC TTG GAA TG 3′; 5. Detection of the vectors carrying the dimers in tandem: Nar dimer: SEQ ID No.49 primer KS 620: 5′ CGC GCG TAA TAC GAC TCA CT 3′; SEQ ID No.46 primer PCV 5:  5′ GTG TGC TCG ACA TTG GTG TG 3′; Kpn dimer: SEQ ID No.49 primer KS 620: 5′ CGC GCG TAA TAC GAC TCA CT 3′; SEQ ID No.48 primer PCV 6:  5′ CTC GCA GCC ATC TTG GAA TG 3′; 6. Differential detection: The pairs of primers used are those described, for example, in paragraphs 4 and 5 above. The procedures using the pairs or primers described in paragraphs 4 and 5 are of particular interest for differentially detecting the circular monomeric forms of specific replicative forms of the virion or of the DNA in replication and the dimeric forms found in the so-called in-tandem molecular constructs. The in-tandem constructs of the viral genome (dimers) such as the constructs used for the preparation of the pBS KS+tandem PCV Kpn I vector, deposited at the CNCM under the number I-1891, 3 Jul. 1997 ( E. coli transformed by said vector) are very interesting for their use in methods of production in sufficient quantity of an inoculum formed of DNA, intended for the virus production, this in the absence of a satisfactory virus production protocol in a cell system. These said methods of production using these in-tandem constructs of the viral genome will allow the virulence factors to be studied by mutation and by way of consequence will be able to be used for the production of a collection of viruses carrying the mutations indicated in the construction of vectors which will have the appropriate tropism and virulence. These vectors with autoreplicative structure have the sought gene transfer properties, especially for their applications in gene therapy, and in vaccinology. Western-Blot Analysis of Recombinant Proteins of the PWD Circovirus of Type A The results were obtained using a specific antiserum of the PWD circovirus produced during test 1 (cf. FIG. 1 ). Type of products analyzed. The analyses were carried out on cell extracts of Sf9 cells obtained after infection by the recombinant baculovirus PCV ORF1. The culture of Sf9 cells was carried out in a 25 cm 2 Petri dish according to the standard culture methods for these cells. After centrifugation, the cell pellets are taken up with 300 μl of PBS buffer (phosphate saline buffer). Electrophoresis (PAGE-SDS) The electrophoresis is carried out on the cell extracts of Sf9 cells obtained previously on 5 samples (cf. Table 1 below) under the following conditions: % polyacrylamide gel: 8%; conditions: denaturing Voltage: 80 V; duration: 135 nm. TABLE 1 Nature of the samples subjected to electrophoresis Well No. 1 2 3 4 5 Sample PM Raoul Raoul Raoul Raoul applied Rainbow 24 h 48 h 72 h 96 h μl of sample 10 15 15 15 15 μl of  0  5  5  5  5 Laemmli 4X Legends to Table 1: Laemmli 4X: loading buffer PM Rainbow: molecular-weight markers (35, 52, 77, 107, 160 and 250 kD) Raoul 24 h, 48 h, 72 h and 96 h: expression products of the ORF1 of the PWD circovirus of type A. Western Blot After electrophoresis, the bands obtained in the different wells are transferred to nitrocellulose membrane for 1 h at 100 v in a TGM buffer (tris-glycine-methanol). The Western blot is carried out under the following conditions: 1) Saturation with a solution containing 5% of skimmed milk; 0.05% of Tween 20 in a TBS 1× buffer (tris buffer saline) for 30 min. 2) 1st antibody: 10 ml of PWD anticircovirus antibody of type A are added diluted to 1/100, then the reaction mixture is incubated for one night at 4° C. Three washes of 10 min in TBS 1× are carried out. 3) 2nd antibody: 10 ml of pig rabbit P164 antibody anti-immunoglobulins, coupled to peroxidase (Dakopath) are added diluted to 1/100, then the reaction medium is incubated for 3 hours at 37° C. Three washes of 10 min in TBS 1× are carried out. 4) Visualization The substrate 4-chloro-1-naphthol in the presence of oxygenated water is used for visualization. Results The results are shown in FIG. 7 . Kinetics of Appearance of Antibodies Specific for the Rep Recombinant Protein of the PWD Circovirus of Type A Expressed in Baculovirus after Infection of Pigs by the PWD Circovirus of Type a (Test 4, cf. FIG. 1 ) After infection of the pigs, a sample of serum of each of the infected pigs is taken at different periods expressed in the table by the date of taking (carried out here in the same year) and is then analyzed by Western blot. The visualization of the specific antibodies is carried out in the manner described previously. The results obtained are shown by Table 2 below. TABLE 2 Kinetics of appearance of specific antibodies Sample Pigs 10/6 16/06 23/06 01/07 08/07 15/07 21/07 A3 1 Neg. Control 2 Neg. B2 Infec. 1 Neg. Neg. Neg. + + ++ +++ RP+ 2 Neg. Neg. Neg. Neg. Neg. Neg. Neg. 3 Neg. Neg. Neg. Neg. + + + 4 Neg. Neg. Neg. Neg. Neg. Neg. ++ Legends to Table 2: A3 control: uninfected control animals; B2 Infec. RP+: animals infected with pig kidney (PK) cells containing the circovirus; Neg.: negative; +, ++, +++: intensity scale of the positive reaction; 10/06, 16/06, 23/06, 01/07, 08/07, 15/07, 21/07: dates expressed in day/month on which the different withdrawals of serum were carried out. Example 2 Cloning, Sequencing and Characterization of the Type B PWD Circovirus (PCVB) The techniques used for cloning, sequencing and characterization of the type B PWD circovirus (PCVB) are those used in Example 1 above for the type A PWD circovirus (PCVA). The nucleic sequence of the strand of (+) polarity of the genome of the PWD circovirus of type B (or PCVB) is represented by the sequence SEQ ID No. 15 in the sequence listing, the nucleic sequence of the strand of (−) polarity of the genome of the PWD circovirus of type B (or PCVB) being represented by the nucleic sequence 3′→5′ of FIG. 8 or by the sequence SEQ ID No. 19 (represented according to the orientation 5′→3′) in the sequence listing. The amino acid sequences SEQ ID No. 24, SEQ ID No. 26 and SEQ ID No. 28 of the sequence listing respectively represent the sequences of the proteins encoded by the nucleic sequences of the 3 open reading frames SEQ ID No. 23 (ORF′1), corresponding to the REP protein, SEQ ID No. 25 (ORF′2) and SEQ ID No. 27 (ORF′3), determined from the sequence SEQ ID No. 15 of the strand of (+) polarity or from the nucleic sequence SEQ ID No. 19 of the strand of (−) polarity of the genome of the PWD circovirus of type B. Example 3 Comparative Analysis of Nucleotide Sequences (ORF1, ORF2 and Genomic) and Amino Acid Sequences Encoded by the ORF1 and the ORF2 of the PWD Circoviruses of Type A (PCVA) and of Type B (PCVB) The results expressed in % of homology are shown in Tables 3 and 4 below. TABLE 3 Compared analysis of the amino acid sequences % homology ORF1 ORF2 PCVA/PCVB 80.4 56.2 TABLE 4 Compared analysis of the nucleotide sequences % homology Genomic ORF1 ORF2 The remainder PCVA/PCVB 70.4 80.4 60.1 66.1 Example 4 Observation of the Disease and Reproduction of the Disease Under Experimental Conditions a) Test No. 1: Observation of the disease The objective is to take breeding animals at the start of disease and to place them under experimental conditions to follow the progression of the pathology and describe all the clinical signs thereof. This first test was carried out on 3 breeding pigs aged 10 weeks of which 2 were already ill (suffering from wasting), and on 3 other pigs aged 13 weeks, not having signs of disease. The clinical observation was spread over a period of 37 days. Two pigs of 10 weeks wasted rapidly (pigs 1 and 2, FIG. 9 ) and had to be painlessly killed 5 and 6 days after their arrival. A single pig exhibited hyperthermia over 5 days and diarrhea. Two other pigs exhibited dyspnea and cough, of which one additionally had hyperthermia, greater than 41° C., for the two first days of its stay. Another pig had retarded growth in the second week (pig 6, FIG. 9 ), without any other clinical sign being recorded. On the lesional level, 5 pigs out of 6 exhibited macroscopic lesions of gray pneumonia, the sixth exhibited cicatricial lesions on the lung. b) Test No. 2: Reproduction of the disease from inocula prepared in farm pigs. The two sick pigs in test 1 served to prepare inocula which were tested in test 2 on specific-pathogen-free (SPF) pigs. The SPF pigs were aged 9 weeks at the time of inoculation. The clinical and lesional results are shown in Table 5. TABLE 5 Summary of the measurements carried out during experimental reproduction of PWD. (The values of the control animals are reported in brackets, the underlined values indicate a difference between infected animals and control animals) Test Measurement 2 3 4 5 6 7 Status of the pigs SPF SPF SPF SPF Conventional Conventional CNEVA field CNEVA CNEVA Age 9 weeks 6 weeks 5 weeks 5 weeks 5 weeks 6–7 weeks Number  4  6 12  8  8  8 Inoculation route Intratracheal Intratracheal Intratracheal + Intratracheal + Intratracheal + Intratracheal + route route intramuscular intramuscular intramuscular intramuscular route route route route Inoculum titer ND* ND* 10 4.53 TCID 50 per ml: 10 4.53 TCID 50 per ml: 10 4.53 TCID 50 per ml: 10 4.53 TCID 50 per ml: per pig 1 ml IM + 5 ml IT 1 ml IM + 5 ml IT 1 ml IM + 5 ml IT 1 ml IM + 5 ml IT Start of 10 days 9–13 days 12–13 days 9–14 days 8–12 days 12 days hyperthermia post-infection post-infection post-infection post-infection post-infection post-infection % of pigs in 100% 83% 92% 100% 75% 88% hyperthermia** Number of  7  4.5  3.3  5.8  7.5 11.6 days of hyperthermia per pig** Maximum 40.4 to 40.6 to 40.2 to 41.6° C. 40.3 to 40.8° C. 40.6 to 42° C. 40.2 to 41.9° C. temperatures*** 41.7° C. 42.3° C. Hyperthermia**** % per week W1  3.5 (3.5)  17 (36)  7 (5)  37 (17)  16 (17)  20 (28) W2   42 (3.5)  7 (13)   13 (1)   21 (3)   52 (10)  37 (28) W3   35 (3.5)   33 (10)   28 (7)   62 (2)   34 (12)   79 (17) W4   21 (3.5)   28 (7)  5 (0)  6 (3)  25 (22)   55 (3) DMG: W1 928 (1053) 417 (357) 564 (620) 650 (589) 401 (407) 509 (512) W2 678 (1028) 428 (617) 503 (718) 612 (584) 294 (514) 410 (310) W3 661 (1000) 771 (642) 381 (657) 520 (851) 375 (586) 435 (440) W4 786 (1100) 550 (657) 764 (778) 641 (696) 473 (610) 451 (681) Contact pigs Yes to 100% Yes to 75% Not tested Not tested Not tested Not tested transmission % of pulmonary 25 75  0 25 25 12 lesions % of ganglionic 17 33 67 25 50 12 lesions *ND: not determined, **hyperthermia when the temperature is greater than 40° C., ***range of maximum temperatures recorded at the individual level, ****the percentage corresponds to the number of temperature recordings greater than 40° C. divided by the total number of temperature recordings in the week on all of the pigs. In this test, there was no wasting, at the very most a retardation of the growth in the second, third or fourth week after infection. These data illustrate that certain breeding conditions probably favor the expression of the disease. c) Tests No. 3 to No. 7: Reproduction of the experimental tests The increase in the number of the experimental tests on pigs had the mastering and better characterization of the experimental model as an objective. All of the results are presented in Table 5. Under the experimental conditions, PWD is thus characterized by a long incubation, of 8 to 14 days, true hyperthermia over 2 to 8 days, a decrease in food consumption and a retardation of the increase in weight on the second, third or fourth week post-infection. The lesional table associated with this clinical expression includes, in the main, ganglionic hypertrophy and lesions of pneumonia. Conclusion The perfection of this experimental model allows the direct etiological role of the PWD circovirus in the disease to be indisputably demonstrated. In addition, this model is an indispensable tool for the understanding of pathogenic mechanisms and the study of future vaccine candidates. Example 5 Demonstration of the Vaccine Composition Protective Efficacy Produced from Nucleic Fragments of PWD Circovirus Sequence 1) Animals Used for the Study Piglets having the PWD disease, reproduced under experimental conditions described in paragraph c) of Example 4, were used in a protocol for evaluating the vaccine composition efficacy, comprising nucleic fragments of PWD circovirus sequence. 2) Tested Vaccine Composition and Vaccination Protocol a) Components Used for the Study The plasmids were obtained from the pcDNA3 plasmid of INVITROGENE pcDNA3ORF− Plasmids These plasmids are plasmids which do not carry a PWD circovirus nucleic acid insert and are used as a negative control plasmid. pcDNA3ORF1+ Plasmid and pcDNA3ORF2+ Plasmid The pcDNA3ORF1+ and pcDNA3ORF2+ plasmids are plasmids which carry a nucleic acid insert of the sequence of the PWD circovirus of TYPE B, respectively an insert comprising the nucleic acid fragment SEQ ID No. 23 (ORF′1) coding for the Rep protein of sequence SEQ ID No. 24 and an insert comprising the nucleic acid fragment SEQ ID No. 25 (ORF′2) coding for the protein of sequence SEQ ID No. 26, probably corresponding to the capsid protein, these nucleic constructs comprising the ATG initiation codon of the coding sequence of the corresponding protein. GMCSF+ Plasmid GM-CSF (granulocyte/macrophage colony stimulating factor) is a cytokine which occurs in the development, the maturation and the activation of macrophages, granulocytes and dendritic cells which present an antigen. The beneficial contribution of the GM-CSF in vaccination is considered to be a cellular activation with, especially, the recruitment and the differentiation of cells which present an antigen. This pcDNA3-GMCSF+ plasmid carries a nucleic acid insert coding for the granulocyte/macrophage colony stimulation factor, the GM-CSF protein. The gene coding for this GM-CSF protein was cloned and sequenced by Inumaru et al. (Immunol. Cell Biol., 1995, 73 (5), 474-476). The pcDNA3-GMCSF+ plasmid was obtained by Dr. B. Charley of INRA of Jouy-en-Josas (78, France). Recombinant Baculoviruses The so-called ORF− baculoviruses are viruses not carrying any insert comprising a nucleic acid fragment capable of expressing a PWD circovirus protein. The so-called ORF1+ (BAC ORF1+) or ORF2+ (BAC ORF2+) baculoviruses are recombinant baculoviruses respectively carrying an insert comprising a nucleic acid fragment SEQ ID No. 23 (ORF′1) and an insert comprising the nucleic acid fragment SEQ ID No. 25 (ORF′2). Adjuvant The adjuvant supplied by the Seppic Company, a subsidiary of AIR LIQUIDE, is the adjuvant corresponding to the reference AIF SEPPIC. b) Vaccination Protocol Weaned piglets aged 3 weeks are divided into four batches A, B, C and D each comprising 8 piglets. Batches A, B and C, aged 3 weeks, each receive a first injection (injection M1) of 1 ml containing 200 micrograms of plasmids (naked DNA) in PBS, pH: 7.2, by the intramuscular route for each of the plasmids mentioned below for each batch, then, at the age of 5 weeks, a second injection (injection M2) comprising these same plasmids. A third injection is carried out simultaneously on the other side of the neck. This third injection comprises 1 ml of a suspension containing 5.10 6 cells infected by recombinant baculoviruses and 1 ml of AIF SEPPIC adjuvant. Batch A (F1) (Control Batch): first injection pcDNA3ORF1−plasmid, pcDNA3ORF2− plasmid and GMCSF+ plasmid. second and third injection (simultaneous) pcDNA3ORF1− plasmid, pcDNA3ORF2− plasmid and GMCSF+ plasmid; Cells transformed by baculoviruses not containing any nucleic acid insert coding for a PWD circovirus protein; AIF SEPPIC adjuvant. Batch B (F2) (Control Batch): first injection pcDNA3ORF1− plasmid, pcDNA3ORF2− plasmid and GMCSF+ plasmid; second and third injection (simultaneous) pcDNA3ORF1−plasmid, pcDNA3ORF2− plasmid and GMCSF+ plasmid; Cells transformed by baculoviruses not containing any nucleic acid insert coding for a PWD circovirus protein; AIF SEPPIC adjuvant. Batch C (F3): first injection pcDNA3ORF1+ plasmid, pcDNA3ORF2+ plasmid and GMCSF+ plasmid; second and third injection (simultaneous) pcDNA3ORF1+ plasmid, pcDNA3ORF2+ plasmid and GMCSF+ plasmid; Cells transformed by BAC ORF1+ and BAC ORF2+ recombinant baculoviruses capable of respectively expressing the Rep protein of sequence SEQ ID No. 24 and the protein of sequence SEQ ID No. 26 of the PWD circovirus of TYPE B. Batch D (F4) (control batch): no injection The batches of piglets B, C and D are infected (tested) at the age of 6 weeks although batch A is not subjected to the test. 3) Observation of the Batches counting of coughing/sneezing: 15 minutes/batch/day; consistency of fecal matter: every day; regular recordings: weekly taking of blood, weighing; weighing of food refuse: 3 times per week; calculation of the daily mean gain in weight (dmg); The daily mean gains were calculated for each of the batches over a period of 28 days following testing (cf. FIG. 10 ), an intermediate calculation of the dmg was likewise carried out for each of the batches over the first and second periods of 14 days. The results obtained are reported below in Table 6. TABLE 6 Daily mean gains F1 F2 F3 F4 d0–d14 411 g 450 g 511 g 461 g d14–d28 623 g 362 g 601 g 443 g d0–d28 554 g 406 g 556 g 452 g Measurement of Hyperthermia The measurement of hyperthermia, of greater than 41° C. (cf. FIG. 11 ) and greater than 40.2° C., was carried out for each of the batches over a total period of 28 days following testing. The results obtained, corresponding to the ratio expressed as a percentage between the number of recordings of heat of greater than 41° C. (or greater than 40.2° C.) and the total number of recordings of heat carried out on all of the pigs per one-week period are reported below in Tables 7 and 8, respectively for the hyperthermia measurements of greater than 41° C. and greater than 40.2° C. TABLE 7 Hyperthermia >41° C. F1 F2 F3 F4 W1 4.1 0. 0. 0. W2 10.7 16. 0. 8.9 W3 4.7 27. 0. 45. W4 0. 0. 0. 7.5 TABLE 8 Hyperthermia >40.2 F1 F2 F3 F4 W1 29.1 10.41 29.1 20.8 W2 28.5 39.2 10.7 37.5 W3 14.3 68.7 25.0 81.2 W4 3.3 17.5 20.0 55 4) Conclusion The recordings carried out clearly show that the animals which received the three injections of a vaccine composition comprising nucleic acid fragments of PWD circovirus according to the invention and/or capable of expressing recombinant proteins of PWD circovirus, in particular of type B, did not exhibit hyperthermia (cf. FIG. 10 ). These animals additionally did not experience a decline in their growth, the dmgs being comparable to those of uninfected control animals (cf. FIG. 9 ). They did not exhibit any particular clinical sign. These results demonstrate the efficacious protection of the piglets against infection with a PWD circovirus of the invention, the primary agent responsible for PWD or FPW, provided by a vaccine composition prepared from a nucleic acid fragment of the nucleic sequence of PWD circovirus according to the invention, in particular of type B, and/or from recombinant proteins encoded by these nucleic acid fragments. These results in particular show that the proteins encoded by the ORF1 and ORF2 of PWD circovirus according to the invention are immunogenic proteins inducing an efficacious protective response for the prevention of infection by a PWD circovirus. Example 6 Serological Diagnosis of PWD Circovirus by Immunodetermination Using Recombinant Proteins or Synthetic Peptides of PWD Circovirus A—Serological Diagnosis with Recombinant Proteins The identification and the sequencing of porcine PWD circovirus allow recombinant proteins of PWD circovirus to be produced by the techniques of genetic recombination well known to the person skilled in the art. By these techniques, recombinant proteins encoded, in particular, by the ORF′2 of the PWD circovirus, type B, were expressed by transformed Sf9 insect cells and then isolated. These recombinant proteins encoded by the ORF′2 are extracted, after culture of the transformed Sf9 cells, by thermal cell lysis by means of 3 cycles of freezing/thawing to −70° C./+37° C. Healthy Sf9 cells or nontransformed control Sf9 cells are also lyzed. These two antigenic fractions originating from nontransformed control Sf9 cells and Sf9 cells expressing the ORF′2 are precipitated at 4° C. by a 60% plus or minus 5% saturated ammonium sulfate solution. Determination of total proteins is carried out with the aid of the Biorad kit. 500 ng of control Sf9 proteins and of semipurified Sf9 proteins expressing the ORF′2, in solution in 0.05 M bicarbonate buffer pH 9.6, are passively adsorbed at the bottom of 3 different cupules of a Nunc Maxisorp microplate by incubation for one night at +4° C. The reactivity of pig sera with respect to each of these antigenic fractions is evaluated by an indirect ELISA reaction of which the experimental protocol is detailed below: Saturation step: 200 μl/cupule of PBS1X/3% semi-skimmed milk, 1 h 30 incubation at 37° C. Washing: 200 μl/cupule of PBS1X/Tween 20: 0.05%, 3 rapid washes. Serum incubation step: 100 μl/cupule of serum diluted to 1/100 in PBS1X/semi-skimmed milk, 1%/Tween 20: 0.05%, 1 h incubation at 37° C. Washing: 200 μl/cupule of PBS1X/Tween 20: 0.05%, 2 rapid washes followed by 2 washes of 5 min. Conjugate incubation step: 50 μl/cupule of rabbit anti-pig conjugate diluted to 1/1000 in PBS1X/semi-skimmed milk, 1%/Tween 20: 0.05%, 1 h incubation at 37° C. Washing: 200 μl/cupule of PBS 1X/Tween 20: 0.05%, 2 rapid washes followed by 2 washes of 5 min. Visualization step: 100 μl/cupule of OPD substrate/citrate buffer/H 2 O 2 , 15 min incubation at 37° C. Stopping of reaction: 50 μl/cupule of 1 N H 2 SO 4 . Reading in a spectrophotometer at 490 nm. Results The results obtained are shown below in Table 9. TABLE 9 Reactivity of Pig Serum Reactivity of Pig Serum not inoculated with inoculated with Antigens Circovirus Circovirus Purified Sf9 control 0.076 0.088 Sf9 expressing 0.071 1.035 purified ORF′2 The results are expressed in optical density measured in a spectrophotometer at 490 nm during analysis by ELISA of the reactivity of pig sera which are or are not inoculated with the type B PWD circovirus according to the protocol indicated above. B—Serological Diagnosis by Synthetic Peptide The epitopic mapping of the proteins encoded, for example, by the nucleic sequences ORF1 and ORF2 of the two types of PWD circovirus (types A and B) additionally allowed immunogenic circoviral epitopes to be identified on the proteins encoded by the nucleic sequences ORF′1 and ORF′2 as well as the specific epitopes of the protein encoded by the nucleic sequence ORF′2 of the type B PWD circovirus. Four specific epitopes of the type B PWD circovirus and one epitope common to the two types of PWD circovirus situated on the protein encoded by the nucleic sequence ORF′2 were synthesized in peptide form. The equivalent peptides in the circovirus of type A were likewise synthesized. All these peptides were evaluated as diagnostic antigens within the context of carrying out a serological test. Results The results obtained are shown in Table 10 below. TABLE 10 Results of the evaluation as a diagnostic antigen of synthetic peptides encoded by the nucleic sequences ORF2 and ORF'2 of PWD circovirus of type A and B. Infected pig serum reactivity Circovirus B Type PWD Conven- Conven- Pep- circo- SPF tional 1 tional 2 Epitopic tide virus Position AA sequence D0/D54 D0/D42 D0/D42 specificity SEQ ID NO:29 121 B  71–85 VDMMRFNINDFLPPG +/−,+++ +/−,+++ −,+++ Circovirus B SEQ ID NO:55 177 B  70–84 NVNELRFNIGQFLPP +/−,+ +/−,+/− +/−,− SEQ ID NO:30 131 B 115–129 QGDRGVGSSAVILDD +/−,+/− ++,++ +/−,+ Circovirus B SEQ ID NO:56 188 A 114–127 TSNQRGVGSTVVIL +/−,− −,+/− +/−,+/− SEQ ID NO:31 133 B 119–134 GVGSSAVILDDNVFTK −,++ ++,+++ +/−,++ SEQ ID NO:57 189 A 118–132 RGVGSTVVILDANFV +/−,− −,+/− +/−,+/− SEQ ID NO:58 146 B 171–185 FTIDYFQPNNKRNQL −,+/− −,++ −,++ Circovirus A&B SEQ ID NO:59 202 A 170–184 DQTIDWFQPNNKRNQ +++,+++ +/−,++ +,++ SEQ ID NO:32 152 B 195–209 VDHVGLGTAFENSIY −,++ +++,+++ +/−,+ Circovirus B SEQ ID NO:60 208 A 194–208 NVEHTGLGYALQNAT −,− −,− −,− +/−, +, ++, +++. Increasing intensities of the reactivities observed in Spot peptides on a nitrocellulose membrane. The porcine sera tested are from animals experimentally infected with the circovirus of type B within the animal houses of the CNEVA. Samples are taken from the animals before inoculation on d0 and 42 days or 54 days after inoculation, on d42, d54. Example 7 Characterization of the Specific Epitopes of the PWD Circovirus of Type B The proteins encoded by the ORF2 of the porcine circoviruses of type A and B were chosen for this study. For each of the ORF2s (types A and B), 56 peptides of 15 amino acids which overlap every 4 amino acids were synthesized, thus covering the whole of the protein (cf. Table 11 below). TABLE 11 Sequence of amino acids of the 56 peptides of 15 amino acids synthesized from the nucleic sequence ORF′2 (type B) and ORF2 (type A) of PWD circovirus with their corresponding spot number (cf. FIG. 12) Type B ORF′2 Type A ORF′2 Spot Spot No. Sequence No. Sequence SEQ ID NO:61 107 HRPRSHLGQILRRRP SEQ ID NO:84 163 TRPRSHLGNILRRRP SEQ ID NO:62 108 SHLGQILRRRPWLVH SEQ ID NO:85 164 SHLGNILRRRPYLVH SEQ ID NO:63 109 QILRRRPWLVHPRHR SEQ ID NO:86 165 NILRRRPYLVHPAFR SEQ ID NO:64 110 RRPWLVHPRHRYRWR SEQ ID NO:87 166 RRPYLVHPAFRNRYR SEQ ID NO:65 111 LVHPRHRYRWRRKNG SEQ ID NO:88 167 LVHPAFRNRYRWRRK SEQ ID NO:66 112 RHRYRWRRKNGIFNT SEQ ID NO:89 168 AFRNRYRWRRKTGIF SEQ ID NO:67 113 RWRRKNGIFNTRLSR SEQ ID NO:90 169 RYRWRRKTGIFNSRL SEQ ID NO:68 114 KNGIFNTRLSRTFGY SEQ ID NO:91 170 RRKTGIFNSRLSREF SEQ ID NO:69 115 FNTRLSRTFGYTVKR SEQ ID NO:92 171 GIFNSRISREFVLTI SEQ ID NO:70 116 LSRTFGYTVKRTTVR SEQ ID NO:93 172 SRLSREFVLTIRGGH SEQ ID NO:71 117 FGYTVKRTTVRTPSW SEQ ID NO:94 173 REFVLTIRGGHSQPS SEQ ID NO:72 118 VKRTTVRTPSWAVDM SEQ ID NO:95 174 LTIRGGHSOPSWNVN SEQ ID NO:73 119 TVRTPSWAVDMMRFN SEQ ID NO:96 175 GGHSQPSWNVNELRF SEQ ID NO:74 120 PSWAVDMMRFNINDF SEQ ID NO:97 176 QPSWNVNELRFNIGO SEQ ID NO:29 121 VDMMRFNINDFLPPG SEQ ID NO:98 177 NVNELRFNIGQFLPP SEQ ID NO:75 122 RFNINDFLPPGGGSN SEQ ID NO:99 178 LRFNIGQFLPPSGGT SEQ ID NO:76 123 NDFLPPGGGSNPRSV SEQ ID NO:100 179 IGQFLPPSGGTNPLP SEQ ID NO:77 124 PPGGGSNPRSVPFEY SEQ ID NO:101 180 LPPSGGTNPLPLPFQ SEQ ID NO:78 125 GSNPRSVPFEYYRIR SEQ ID NO:102 181 GGTNPLPLPFQYYRI SEQ ID NO:79 126 RSVPFEYYRIRKVKV SEQ ID NO:103 182 PLPLPFQYYRIRKAK SEQ ID NO:80 127 FEYYRIRKVKVEFWP SEQ ID NO:104 183 PFQYYRIRKAKYEFY SEQ ID NO:81 128 RJRKVKVEFWPCSPI SEQ ID NO:105 184 YRIRKAKYEFYPRDP SEQ ID NO:82 129 VKVEFWPCSPITQGD SEQ ID NO:106 185 KAKYEFYPRDPITSN SEQ ID NO:83 130 FWPCSPITQGDRGVG SEQ ID NO:107 186 EFYPRDPITSNQRGV SEQ ID NO:30 131 SPITQGDRGVGSSAV SEQ ID NO:108 187 RDPITSNQRGVGSTV SEQ ID NO:31 132 QGDRGVGSSAVILDD SEQ ID NO:109 188 TSNQRGVGSTVVILD SEQ ID NO:110 133 GVGSSAVILDDNFVT SEQ ID NO:136 189 RGVGSTVVILDANFV SEQ ID NO:111 134 SAVILDDNFVTKATA SEQ ID NO:137 190 STVVILDANFVTPST SEQ ID NO:112 135 LDDNFVTKATALTYD SEQ ID NO:138 191 ILDANFVTPSTNLAY SEQ ID NO:113 136 FVTKATALTYDPYVN SEQ ID NO:139 192 NFVTPSTNLAYDPYI SEQ ID NO:114 137 ATALTYDPYVNYSSR SEQ ID NO:140 193 PSTNLAYDPYINYSS SEQ ID NO:115 138 TYDPYVNYSSRIITIT SEQ ID NO:141 194 LAYDPYINYSSRHTI SEQ ID NO:116 139 YVNYSSRHTITQPFS SEQ ID NO:142 195 PYINYSSRHTIRQPF SEQ ID NO:117 140 SSRHTITQPFSYHSR SEQ ID NO:143 196 YSSRIITIRQPFTYHS SEQ ID NO:118 141 TITQPFSYHSRYFTP SEQ ID NO:144 197 HTIRQPFTYHSRYFT SEQ ID NO:119 142 PFSYHSRYFTPKPVL SEQ ID NO:145 198 QPFTYHSRYFTPKPE SEQ ID NO:120 143 HSRYFTPKPVLDFTI SEQ ID NO:146 199 YHSRYFTPKPELDQT SEQ ID NO:121 144 FTPKPVLDFTIDYYFQ SEQ ID NO:147 200 YFTPKPELDQTIDWF SEQ ID NO:122 145 PVLDFTIDYFQPNNK SEQ ID NO:148 201 KPELDQTIDWFQPNN SEQ ID NO:123 146 FTIDYFQPNNKRNQL SEQ ID NO:149 202 DQTIDWFQPNNKRNQ SEQ ID NO:124 147 YFQPNNKRNQLWLRL SEQ ID NO:150 203 DWFQPNNKRNQLWLH SEQ ID NO:125 148 NNKRNQLWLRLQTAG SEQ ID NO:151 204 PNNKRNQLWLHLNTH SEQ ID NO:126 149 NQLWLRLQTAGNVDH SEQ ID NO:152 205 RNQLWLHLNTNTNVE SEQ ID NO:127 150 LRLQTAGNVDHVGLG SEQ ID NO:153 206 WLHLNTHTNVEHTGL SEQ ID NO:128 151 TAGNVDHVGLGTAFE SEQ ID NO:154 207 NTNTNVEHTGLGYAL SEQ ID NO:32 152 VDHVGLGTAFENSIY SEQ ID NO:155 208 NVEHTGLGYALQNAT SEQ ID NO:129 153 GLGTAFENSIYDQEY SEQ ID NO:156 209 TGLGYALQNATTAQN SEQ ID NO:130 154 AFENSIYDQEYNIRV SEQ ID NO:157 210 YALQNATTAQNYVVR SEQ ID NO:131 155 SIYDQEYNIRVTMYV SEQ ID NO:158 211 NATTAQNYVVRLTIY SEQ ID NO:132 156 QEYNIRVTMYVQFRE SEQ ID NO:159 212 AQNYVVRLTIYVQFR SEQ ID NO:133 157 IRVTMYVQFREFNFK SEQ ID NO:160 213 VVRLTIYVQFREFIL SEQ ID NO:134 158 MYVQFREFNFKDPPL SEQ ID NO:161 214 TIYVQFREFILKDPL SEQ ID NO:135 159 VQFREFNFKDPPLNP SEQ ID NO:162 215 YVQFREFILKDPLNE These peptides were synthesized according to the “spot” method which consists in simultaneous synthesis of a large number of peptides on a cellulose solid support, each site of synthesis of a peptide constituting a spot (Synt:em, NIMES). This method involves orientation of the peptides on the plate, these being fixed covalently by the carboxy-terminal end. A spot represents approximately 50 nmol of peptide. The reference of the spots and corresponding peptide sequences is given in Table 11. These membranes were used for immunoreactivity tests with respect to serum of SPF pigs which were or were not infected experimentally with the type B PWD circoviral strain as well as with respect to sera of infected pigs from conventional farms (conventional farms 1 or 2). This study allowed specific immunoreactive peptides of the circovirus of type B corresponding to the spots No. 121, No. 132, No. 133 and No. 152 (respectively of amino acid sequences SEQ ID No. 29, SEQ ID No. 30, SEQ ID No. 31 and SEQ ID No. 32) to be demonstrated. An illustration is shown in FIG. 12 where the membranes are visualized with an infected pig serum coming from a conventional farm. Nonspecific immunoreactive peptides of type [lacuna] were likewise demonstrated, among which we shall keep the peptide No. 146 SEQ ID No. 123 which is strongly immunogenic. A comparison between the peptide sequences of circoviruses of type A and B ( FIG. 13 ) indicates a divergence ranging from 20 to 60% for the specific immunoreactive peptides of the type B, and a weaker divergence (13%) between the nonspecific peptides. Example 8 Protection of Swine from Post-Weaning Multisystemic Wasting Syndrome (PMWS) Conferred by Procine Circovirus TypeB (PCV-B) ORF′2 Protein The ORF′1-encoded protein (REP) and ORF′2-encoded putative capsid protein of PCV-B were expressed, either in insect cells by recombinant baculovirus vectors, or in mammalian cell lines by transfection with plasmidic expression vectors. These two circovirus-derived proteins were detectable in both expression system. As evaluated by weight gains, hyperthermia and absence of lesions following challenge, the pigs were protected against a virulent circovirus challenge after one first DNA immunization with plasmids directing ORF′2 protein and GM-CSF expression and a second injection, 15 days later, with the same plasmid preparation plus the ORF′2 recombinant protein. A lower level of protection was observed when the pigs were vaccinated with ORF′1 protein, as opposed to pigs vaccinated with ORF′2 protein. A. Development of an Experimental Model of PMWS in Swine: Eight 3 week-old SPF pigs were inoculated intratracheally (5 ml) and intramuscularly (1 ml). B. Production and Control of PCV-B Plasmids: PCV-B ORF′1 and ORF′2 genes, isolated from PCV-B challenge strain, have been cloned into vector plasmid pcDNA3.1. All constructs have been validated through a partial sequencing of the PCV-B genes in the final plasmids and expression control by immunoperoxidase on PK15 cells respectively transfected with each plasmid, using swine polyclonal antibodies. Plasmid encoding GM-CSF has been co-administered. C. Construction of Recombinant Baculoviruses: ORF′1 and ORF′2 proteins were expressed under polyhedrin promoter control. Recombinant proteins were detected by western-blot using swine polyclonal antibodies. D. Vaccination and Challenge: Four groups of 7 pigs were vaccinated intramuscularly at day 0 (Do), two weeks later, they received the same plasmid preparation plus the recombinant baculovirus. E. Monitoring: All groups of pigs were housed in isolated experimental units with air filtration and low air pressure. Clinical observations and rectal temperatures were recorded every day. The pigs were weighed weekly. F. Conclusions Expression of PCV-B ORF′2 or PCV-B ORF′1 in swine resulted in a significantly enhanced level of protection as evaluated by weight evolution and body temperature evolution following challenge with PCV-B circovirus. These results are summarized in FIGS. 14 and 15 . The invention described herein may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The specific embodiments previously described are therefore to be considered as illustrative of, and not limiting, the scope of the invention. Additionally, the disclosure of all publications and patent applications cited above and below, including International Patent Application No. PCT/FR98/02634, filed Dec. 4, 1998, and published as International Publication No. WO 99/29871 on Jun. 17, 1999, are expressly incorporated herein by reference in their entireties to the same extent as if each were incorporated by reference individually. BIBLIOGRAPHIC REFERENCES Allan, G. 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SEQUENCE LISTING This application contains a sequence listing submitted in accordance with 37 CFR 1.52(e), compact discs containing two copies of the sequence listing in lieu of a paper copy, said disc copies created on Jul. 18, 2006, each file containing the identical sequence listing 159 KB file (both named “09514245seq.txt”) which sequence listing is hereby incorporated into the present specification.

1a

BACKGROUND OF INVENTION 1. Technical Field The present invention relates to chiropractic aids used accompanying chiropractic therapy, and in particular to chiropractic aids for chiropractic therapy to correct curvature of the spine. 2. Description of the Related Art Knee pillows and rectangular pillows are conventional examples of chiropractic aids used on the floor or bed. A knee pillow that is commercially available is a triangular cylinder whose transverse length is 40 cm, and in cross-sectional contour is a triangle whose sides are 25 cm×27 cm×30 cm in length. A specific example of this pillow is represented by E (and referred to as “knee pillow E ” hereinafter) in FIG. 12 . The knee pillow E is put under the legs in the supine position. A rectangular pillow that is commercially available is a quadrilateral cylinder whose sides are 8 cm×13 cm×33 cm in length. A specific example of this pillow is represented by F (and referred to as “rectangular pillow F ” hereinafter) in FIG. 13 . An additional example of such chiropractic aids is a chest-resting pad used when the treatment bed does not have a hollow to accommodate the face. This chest-resting pad is wedge-shaped in cross-sectional contour in the portion on which the chest rests, and oblong in the portion for the face; its width is the width of the body or so; and a U-shaped notch that the face enters is formed in the center of the rectangular portion. Any of these therapeutic aids are used by therapists while giving therapeutic treatment. When a human being is standing erect, the spine in its normal condition, which is shown in FIG. 19 —a left-side view of the spine—is anteroposteriorly curved by the groups of muscles that support it. Curvature in the lumbosacral region, indicated as Y in FIG. 19, is particularly crucial. The curvature in the lumbosacral region Y is balanced erect by muscle groups—one specific example of which are the iliacus muscles—involving the front and back of the sacrum ( S in FIG. 19 ), and by muscle groups—one specific example of which are the psoas major muscles—involving the front and back of the lumbar vertebrae ( LV in FIG. 19 ). On the other hand, in the supine position the spine normally becomes nearly horizontal, that is, the anteroposterior curvature in the lumbosacral region Y approaches being truly upright, as is illustrated in FIG. 20 A. Notwithstanding what curvature in the lumbosacral region should be, in daily life: a) one and the same posture is often assumed for long periods, leading to muscle fatigue and muscle tension because only the same muscles are used, and giving rise to deterioration of the abdominal and back muscles; and b) working long hours in a forward-leaning posture increases frontward distortion (lordotic curvature) in the lumbar vertebrae, because the back muscles and extensor muscle groups of the trunk, such as those in the anterior side of the thighs, are extensively used while one is unawares. Moreover, c) often being in a posture of sitting in place tends to deteriorate the flexor muscle groups of the trunk, such as the abdominal muscles and the muscles of the buttocks, and makes the extensor muscle groups of the trunk relatively strong, which also increases frontward distortion (lordotic curvature) in the lumbar vertebrae. Compounding of these causes ends up leaving anteroposterior curvature in the lumbosacral region Y in the same state even when in the supine position, because the muscle-group tension that acts when standing upright persists. FIG. 20B illustrates this condition. When this muscle-group tension remains, sustaining curvature in the lumbosacral region Y as shown in FIG. 20B, distortion is induced in the spine, which has various bad effects—for example, giving rise to low-back pain. Therefore, the present inventor invented—and filed Japanese Pat. App. No. 2001-151373 on—aids for active corrective therapy in order to correct lumbosacral anteroposterior curvature in the supine position and horizontally condition the spine, in order that is, to make anteroposterior curvature in the lumbosacral region truly upright. This invention involves aids for chiropractic therapy used accompanying chiropractic treatment, and renders chiropractic aids lent the capacity to release tension in the muscle groups that act to form anteroposterior curvature in the lumbosacral region of the spine, so as to enable correcting anteroposterior curvature in the lumbosacral region to be close to truly upright. The invention in particular is the utilizing of three types of wedge-shaped pad, whose cross-sectional contour is wedge-shaped and whose transverse width is the width of the body or so—being: a short-span wedge-shaped pad B , as shown in FIG. 9, of length that covers the buttocks when the ridge of the wedge is set against the lumbosacral region; a mid-span wedge-shaped pad C , as shown in FIG. 10, of length to reach the knee; and a long-span wedge-shaped pad D , as shown in FIG. 11, of length to cover the parietal region—and employing one pad to three of the pads in combination, according to different figures and to individual differences in anteroposterior curvature in the lumbosacral region of the spine, to enable correction of lumbosacral anteroposterior curvature into a condition at will in a range extending to truly upright. The invention furthermore is the utilization of a convertible triangular pillow—which is characterized in that: two right-triangular cylindrical members whose cross-sectional contour is made up of right-triangular shapes having a long side and a short side are combined; the right-angle corners of right-triangular cylinders are hinged together; and surface fasteners are provided respectively on the surfaces defined by the right-angle corner and the long side, and the right-angle corner and the short side; and by fastening with the surface fasteners the surfaces defined by the matching short sides, and the surfaces defined by the matching long sides, when the surface defined by any chosen side is made the base of the triangular cylinder, the angle of the apex of the triangular cylinder can be changed—wherein setting the convertible triangular pillow against the underside of the lower legs to flex the lower legs and mitigate tension in the iliopsoas muscles enables correction of lumbosacral anteroposterior curvature into a condition, as far as truly upright, at will. Alternatively, the abovementioned three types of pads B, C and D and the above-described convertible triangular pillow are employed in combination, according to individual differences/differences in figure, making it possible to correct lumbosacral anteroposterior curvature into a condition, as far as truly upright, at will. The foregoing invention relates to aids for chiropractic therapy used accompanying chiropractic treatment, and rendered chiropractic aids lent the capacity to release tension in the muscle groups that act to form anteroposterior curvature in the lumbosacral region of the spine, so as to enable correcting anteroposterior curvature in the lumbosacral region to be close to truly upright. Then lone or combined use of the three types of wedge-shaped pad—which are the short-span wedge-shaped pad B , the mid-span wedge-shaped pad C , and the long-span wedge-shaped pad D —as well as the convertible triangular pillow, and employing in combination with knee pillow E and rectangular pillow F was effective in that individual differences, such as different physiques and figures, could be handled. Nevertheless, a drawback has been that kinds of chiropractic aids employed to handle individual differences such as differences in physique and figure have been numerous. SUMMARY OF INVENTION The present invention remedies the drawback just noted, making it possible to handle individual differences such as differences in physique and figure by means of a simple chiropractic therapy aid. The present invention is employed accompanying chiropractic therapy to correct anteroposterior curvatures in the lumbosacral region of the spine, wherein as a chiropractic treatment aid, a convertible triangular pillow is principally utilized. From the following detailed description in conjunction with the accompanying drawings, the foregoing and other objects, features, aspects and advantages of the present invention will become readily apparent to those skilled in the art. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a perspective view showing convertible triangular pillow A; FIG. 2 is an overall perspective view showing the angle of apex increases greatly in the order FIGS. 2A, 2 B, 2 C, 2 D and 2 E; FIG. 3 shows an example of using a separated convertible triangular pillow A alone, wherein the angle of apex increases in the order FIG. 3A, 3 B, 3 C, and 3 D; FIG. 4 illustrates Use Example 1 in which two single convertible triangular pillows A are combined, wherein the apex angle increases in the order FIGS. 4A, 4 B, 4 C, and 4 D; FIG. 5 illustrates Use Example 2 in which two single convertible triangular pillows A are combined, wherein the apex angle increases in the order FIGS. 5A, 5 B, 5 C, and 5 D; FIG. 6 illustrates Use Example 3 in which two single convertible triangular pillows A are combined, wherein the height of FIG. 6A is higher than 6 B; FIG. 7 is a plan view of non-slip sheets attached to each side of convertible triangular pillow A; FIG. 8 is examples (FIGS. 8A-8D) of explanatory use diagrams written on a face of the convertible triangular pillow; FIG. 9 is an overall perspective view showing short wedge-shaped pad B; FIG. 10 is an overall perspective view showing a medium wedge-shaped pad C; FIG. 11 is an overall perspective view showing a long wedge-shaped mat D; FIG. 12 is a perspective view of a publicly known knee pillow E; FIG. 13 is a perspective view of a publicly known square pillow F; FIG. 14 is for (combined) Use Example 2; FIG. 15 is for (combined) Use Example 3; FIG. 16 is for (combined) Use Example 4; FIG. 17 is for (combined) Use Example 5; FIG. 18 is for (combined) Use Example 6; FIG. 19 is a schematic view of the spine showing lumbosacral region Y ; and FIG. 20 shows the normal curvatures of the spine in the supine position FIG. 20A, abnormal curvatures of the spine with a greater lordotic curvature in lumbosacral region Y FIG. 20B, reduced lordotic curvature with knee bent even in the case of FIG. 20B with abnormal curvatures FIG. 20 C. DETAILED DESCRIPTION Examples of the present invention are described according to figures as follows. Chiropractic treatment aids having to do with the present invention are used accompanying chiropractic therapy, in which two right-triangular cylindrical members are combined, in which the right-triangular cylindrical members are connected in order to be revolvable and detachable at the right angle edge, and each plane of short side and each plane of long side of two right-triangular cylindrical members are fastened each other, and a separated right-triangular cylindrical member is solely used, or two are combined to use as a convertible triangular pillow. This convertible triangular pillow is shown as A in FIG. 1 (convertible triangular pillow A ). In addition, the present invention means treatment aids for chiropractic therapy comprising convertible triangular pillow A , combined with three types of wedge-shaped pad in which its cross-section is wedge-shaped and its width is nearly the same as the width of body, comprising a short wedge-shaped pad which covers the buttock when its point of wedge-shape contacts the lumbosacral region, a medium wedge-shaped pad which reaches the knee and a long wedge-shaped pad which covers the parietal region, in which the medium wedge-shaped pad has a shallow concave part with long axis for thigh at the top side, and the long wedge-shaped pad has a shallow concave part for the occiput at the top side. In this case, more than one of three types of wedge-shaped pad are stacked to use. Furthermore, publicly known square-pole-shaped square pillow can be combined with convertible triangular pillow A or combination of convertible triangular pillow A and three types of wedge-shaped pad. Embodiment 1 For a convertible triangular pillow A , as shown by A in FIG. 1, two right-triangular cylindrical members 1 a and 1 b whose cross-sectional contour is made up of right-triangular shapes having a 37-cm long side and a 20-cm short side were prepared. Also, a surface fastener 2 of 5.0 cm width was prepared. Then surface fasteners 2 a and 2 b of 2.5 cm width were attached to the right-triangular cylindrical members 1 a and 1 b , stretching along their right-angle corner to their long sides, and surface fasteners 3 and 4 of 2.5 cm width were respectively attached on the edge surface opposite the right-angle corner, in the plane defined by the right-angle corner and the short side. The two right-triangular cylindrical members 1 a and 1 b prepared in this way are mated at the faces defined by the counterpart short sides, and surface fastener 2 is matched with surface fasteners 2 a and 2 b fastened along the right-angle corner running to the long sides, to dual-combine the right-triangular cylindrical members 1 a and 1 b , and de/reattachably hinging them the right-angle corners of the right-triangular cylinders. Further, surface fasteners 3 and 4 being attached at the edge surface opposite the right-angle corner, in the plane defined by the right-angle corner and the short side, makes it so that the faces defined by the short sides can be firmly fixed to each other with surface fastener 2 and surface fasteners 3 and 4 . Materials of the convertible triangular pillow A are publicly known materials such as leather, imitation leather and cloth for the surface, and publicly known materials such as sponge and foam for inside. In Embodiment 1, the cross-section of the convertible triangular pillow A is 37 cm in the long side and 20 cm in the short side. However, it is possible to change length of the cross-section of the convertible triangular pillow A , if necessary. Accordingly, it can be 34 cm in the long side and 18 cm in the short side, or 39 cm in the long side and 21 cm in the short side. FIG. 2 shows variable pillow A is combined using surface fastener at the right angle edge to connect the right-triangular cylindrical members 1 a and 1 b in order to be revolvable. In this way, one of the planes of triangle pole become base, and the apex of triangle pole can be changed as shown in FIGS. 2A to 2 E in FIG. 2 . The angle of apex of the convertible triangular pillow A increases greatly in order of FIGS. 2A, 2 B, 2 C, 2 D and 2 E. This example is same as the example shown in FIG. 2 of Patent Application No. 2001-151373. FIG. 3 shows surface fastener 2 at the right angle edge of right-triangular cylindrical members 1 a and 1 b is taken off so as to use each right-triangular cylindrical member 1 a and 1 b separately. In this case, the angle of apex of right-triangular cylindrical members 1 a and 1 b increases in order of FIGS. 3A, 3 B, 3 C, and 3 D. FIG. 4 shows right-triangular cylindrical members 1 a and 1 b are separated. One is placed with its plane of right angle edge and long side as a base, and the other is combined so as not to face each plane of hypotenuse each other. The angle of apex made by right-triangular cylindrical members 1 a and 1 b increases in order of FIGS. 4A, 4 B, 4 C, and 4 D. In the same way, FIG. 5 shows right-triangular cylindrical members 1 a and 1 b are separated. One is placed with the right angle edge up, and the other is combined so as not to face each plane of long side each other. The angle of apex made by right-triangular cylindrical members 1 a and 1 b increases in order of FIGS. 5A, 5 B, 5 C, and 5 D. Furthermore, FIG. 6A shows right-triangular cylindrical members 1 a and 1 b are separated. One is placed with its plane of right angle edge and long side as a base, and the other is placed with its plane of right angle edge and long side up, and each plane of hypotenuse is faced to place two right angle edges in symmetry so as to form a rectangular cross-section. In the same way, FIG. 6B shows right-triangular cylindrical members 1 a and 1 b are separated. One is placed with its plane of hypotenuse as a base and with its plane of right angle edge up, and the other is placed with its plane of right angle edge as a base, and each plane of long side is faced to place two right angle edges in symmetry so as to form a parallelogram in cross-section. In this case, the height of FIG. 6A is higher than 6 B. Embodiment 2 Since convertible triangular pillow A of the present invention has a lot of variation for use, as described in Embodiment 1, (1) the convertible triangular pillow A is used, in which two right-triangular cylindrical members 1 a and 1 b are combined, in which the right-triangular cylindrical members are connected in order to be revolvable at the right angle edge using surface fastener 2 , and surface fastener 3 and 4 attached at the edge parallel to the right angle edge of the plane of the right angle edge by the short side so as to fasten each plane with the short side, (2) the convertible triangular pillow A is used, in which two right-triangular cylindrical members 1 a and 1 b are combined, in which the right-triangular cylindrical members are connected in order to be revolvable at the right angle edge using surface fastener 2 , and planes of the right angle edge by the long side are faced each other, (3) surface fastener 2 at the right angle edge of right-triangular cylindrical members 1 a and 1 b is taken off so as to use each right-triangular cylindrical member 1 a and 1 b separately, (4) surface fastener 2 at the right angle edge of right-triangular cylindrical members 1 a and 1 b is taken off to combine two right-triangular cylindrical members 1 a and 1 b so as not to face each plane of hypotenuse and each plane of long side each other, (5) surface fastener at the right angle edge of right-triangular cylindrical members 1 a and 1 b is taken off to face each plane of hypotenuse and each plane of long side of each right-triangular cylindrical member 1 a and 1 b each other so as to form a rectangle or parallelogram in cross-section, examples are shown how to attach non-slip sheets 5 in all planes except triangle planes of right-triangular cylindrical members 1 a and 1 b in order to ensure stability in all variation for use. Non-slip sheets are about 5 cm long, about 1.5 cm wide and about 00 mm thick, and made of elastic material such as natural rubber, synthetic rubber, silicone rubber. It is not restrict to only these sizes and materials for the non-slip sheet and anything should be used to get the same effect. As for the place to be attached, non-slip sheets are attached from the outside edge of four corners to inside in each plane. In the plane with surface fastener, all non-slip sheets are attached parallel to the right triangle edge in a space where surface fasteners are not attached. As for the way of attaching, publicly known ways such as using bond and sewing are used. FIG. 7A shows an example of plane of right triangle edge by short side. FIG. 7B shows an example of plane of right triangle edge by long side. FIG. 7C shows an example of plane of hypotenuse. Embodiment 3 Since convertible triangular pillow A of the present invention has a lot of variation for use, as described in Embodiment 1 and 2, purpose of use, instructions for use and representative examples are indicated in manner of printing, etc. on the face of convertible triangular pillow A for the user's convenience. First, as for purpose of use, a phrase such as, “Purpose of use: This is a pillow for forming the most relaxed posture for you” is put in the surface 1 b shown in FIG. 2 B. Next, as for notes, displayed in the surface 1 a shown FIG. 2B are phrases such as: “Notes: 1) Please choose a combination according to your most relaxed position. 2) Your most relaxed position” is not always the same. 3) If you feel uncomfortable lying down, please look for a better posture. 4) Don't just put up with it. 5) For more details, please consult the attached instruction manual.” Needless to say, the surfaces 1 a and 1 b shown in FIG. 2B can be upside down. And the content of the indication is not limited to the above phrases. As for representative examples: FIG. 8A shows an example of sign displaying as a group the use examples of FIGS. 2A through 2E, for attachment to the surface 1 b in FIG. 2C; FIG. 8B shows an example of sign displaying as a group the use examples of FIGS. 3A through 3D, and FIGS. 6A and 6B for attachment to the surface 1 a in FIG. 2D; FIG. 8C shows an example of sign displaying as a group the use examples of FIG. 4A to 4 D for attachment to the surface 1 a in FIG. 2E; and FIG. 8D shows an example of sign displaying as a group the use examples of FIG. 5A to 5 D for attachment to the surface 1 b in FIG. 2 E. These are examples to be displayed in 1 b shown in FIG. 2C, 1 a shown in FIG. 2D, 1 a shown in FIG. 2E and 1 b shown in FIG. 2 E. These surfaces and Use Examples to be displayed can be chosen as appropriate, and not limited to the above examples. In this way, users can try a lot of variation smoothly without instructions manual because the note and examples are indicated on the body of convertible triangular pillow A . Embodiment 4 In the present invention, three types of wedge-shaped pad used together with convertible triangular pillow A are the same as ones described in the patent application No. 2001-151373. Specifically, short wedge-shaped pad B is a triangle pole with a cross-section of right triangle as shown in B of FIG. 9 . Its right angle side is 10 cm long, the other side is 15 cm long, and the width is 45 cm wide. Medium wedge-shaped pad C is a triangle pole with a cross-section of right triangle as shown in C of FIG. 10 . Its right angle side is 10 cm long, the other side is 50 cm long, and the width is 45 cm wide. It has a shallow concave part 5 with long axis for thigh in the top plane of long side made in the plane of right angles. A long wedge-shaped pad D is a triangle pole with a cross-section of right triangle as shown in D of FIG. 11 . Its right angle side is 10 cm long, the other side is 55 cm long, and the width is 45 cm wide. It has a shallow concave part 6 for the head in the top plane of long side. Materials of the three types of wedge-shaped pad are publicly known materials such as leather, imitation leather and cloth for the surface, and publicly known materials such as sponge and foam for inside. In Embodiment 3, specific figures for the length of each wedge-shaped pad are described, however, these figures are not limited for the three types of wedge-shaped pad used together with the present invention, and can be changed as appropriate according to the personal differences in size and frame. Use Example 1 The following is an explanation with diagrams about examples of convertible triangular pillow A , examples of combination of convertible triangular pillow A and three types of wedge-shaped pad comprising short wedge-shaped pad B , medium wedge-shaped pad C and long wedge-shaped pad D , and examples of combination with publicly known square-pole-shaped square pillow. In the examples shown in diagrams, all convertible triangular pillow A and three types of wedge-shaped pad contact its point to the center of lumbosacral region Y . In addition, examples of combination with square pillow F are also described. First, when convertible triangular pillow A is used, head is put in left side of FIG. 2 . At FIGS. 2A to 2 D, the point of left side of convertible triangular pillow A contacts the center of lumbosacral region Y , and then the apex of convertible triangular pillow A is placed behind the knee so as to put foot outside of the point of right side of convertible triangular pillow A . In this way, the leg is put on the convertible triangular pillow A . In FIG. 2E, knees are deeply bent to hold the convertible triangular pillow A inside the knee. Now in the following use examples, a displacement angle indicating the extent to which an anteroposterior curvature in the lumbosacral region Y of the spine is forcedly brought near to horizontal, i.e., truly upright, in the present invention is taken as a correction angle # of the sacrum to the lumbar vertebra. Originally, the correction angle # is shown as the angle to the horizontal line. However, in this example, the angle is shown to the vertical line in order to avoid a complicated diagram with horizontal line. This applied to all of the following examples. In the example shown in FIG. 3, the same way stated above applies to the case that surface fastener 2 at the right-triangular cylindrical members 1 a and 1 b is taken off so as to use each right-triangular cylindrical member 1 a and 1 b separately. In the examples shown in FIGS. 4 and 5, the same way stated above applies to the case that the separated two right-triangular cylindrical members 1 a and 1 b are combined to use. In the following examples, correction angle #, the sacral angle to the lumbar vertebra, is defined, in this invention, as the degree of correction made after anteroposterior curvatures at lumbosacral region Y are compulsorily corrected to be horizontal, or nearly flat. For Use Example 1, in FIG. 2, correction angle # turns out to be FIG. 2 A< 2 B< 2 C< 2 D< 2 E. In FIG. 3, correction angle # turns out to be FIG. 3 A< 3 B< 3 C< 3 D. In FIG. 4, correction angle # turns out to be FIG. 4 A< 4 B< 4 C< 4 D. In FIG. 5, correction angle # turns out to be FIG. 5 A< 5 B< 5 C< 5 D. In Use Example 1, diagrams showing relation to human body are omitted. Use Example 2 Examples in FIG. 14 shows surface fastener 2 at the right angle edge of right-triangular cylindrical members 1 a and 1 b is taken off so as to use each right-triangular cylindrical member 1 a and 1 b separately, and one or two of short wedge-shaped pad B , medium wedge-shaped pad C and long wedge-shaped pad D used together with the present invention are combined to use. (1) FIG. 14A shows inclination is made from lumbosacral region Y to the head supported with long wedge-shaped pad D at the back, and additionally, right-triangular cylindrical members 1 a and 1 b shown in FIG. 3A are placed under the leg so that anteroposterior curvatures at lumbosacral region Y are corrected to be nearly flat in the supine position. (2) FIG. 14B shows inclination is made from lumbosacral region Y to the head supported with long wedge-shaped pad D at the back, and additionally, right-triangular cylindrical members 1 a and 1 b shown FIG. 3A put on medium wedge-shaped pad C are placed under the leg, which makes inclination from the knee to lumbosacral region Y , and lordotic curvature of the sacrum to the lumbar vertebra is decreased and hip joint is lightly flexed because the leg is raised by the pads, and then anteroposterior curvatures at lumbosacral region Y are corrected to be nearly flat in the supine position. (3) FIG. 14C and 14D shows inclination is made from lumbosacral region Y to the head supported with long wedge-shaped pad D at the back, and inclination is made from the buttock to lumbosacral region Y with short wedge-shaped pad B at the buttock to support the apex of sacrum from the back of the buttock, and additionally, right-triangular cylindrical members 1 a and 1 b shown in FIG. 3C and 3D are placed under the leg, which decreases lordotic curvature of the sacrum to the lumbar vertebra, and then anteroposterior curvatures at lumbosacral region Y are corrected to be nearly flat in the supine position. In the following example, as stated above, although originally, the correction angle # is shown as the angle to the horizontal line, in this example, the angle is shown to the vertical line in order to avoid a complicated diagram with horizontal line. In Use Example 2, correction angle # turns out to be FIG. 14 A< 14 B< 14 C< 14 D. Use Example 3 In FIG. 15, surface fasteners 2 are taken off from the right angle edge of the right-triangular cylindrical members 1 a and 1 b of the convertible triangular pillow A shown in FIGS. 4C and 4D, and FIG. 5D in order to separate and combine the right-triangular cylindrical members 1 a and 1 b , and long wedge-shaped pad D used together with the present invention and square pillow F shown in FIG. 13 are combined to use. Since the way of using is same as Use Example 1 and 2, explanation is omitted. (1) FIG. 15A shows an example of use combined with FIG. 4 C and long wedge-shaped pad D. (2) FIG. 15B shows an example of use combined with FIG. 5 D and long wedge-shaped pad D. (3) FIG. 15C shows an example of use combined with FIG. 4 D and long wedge-shaped pad D. (4) FIG. 15D shows an example of use combined with FIG. 5 D and long wedge-shaped pad D , and additionally square pillow F. In Use Example 3, correction angle # turns out to be FIG. 15 A< 15 B< 15 C< 15 D. Use Example 4 In FIG. 16, surface fasteners 2 are taken off from the right angle edge of the right-triangular cylindrical members 1 a and 1 b of the convertible triangular pillow A shown in FIG. 3B and 3D, and FIG. 5A in order to separate the right-triangular cylindrical members 1 a and 1 b to use it alone separately or combine, and one or two of three types of wedge-shaped pad comprising short wedge-shaped pad B , medium wedge-shaped pad C and long wedge-shaped pad D used together with the present invention and square pillow F are combined to use. (1) FIG. 16A shows an example of use combined with FIG. 3B, medium wedge-shaped pad C , long wedge-shaped pad D and additionally square pillow F. (2) FIG. 16B shows an example of use combined with FIG. 3D, short wedge-shaped pad B , long wedge-shaped pad D and additionally square pillow F. (3) FIG. 16C shows an example of use combined with FIG. 5A, long wedge-shaped pad D and additionally square pillow F. In Use Example 4, correction angle # turns out to be FIG. 16 A< 16 B< 16 C. Use Example 5 In FIG. 17, surface fasteners 2 are taken off from the right angle edge of the right-triangular cylindrical members 1 a and 1 b of the convertible triangular pillow A shown in FIG. 3C, FIGS. 4C and 4D, and FIG. 5C in order to separate the right-triangular cylindrical members 1 a and 1 b to use it alone separately or combine, and one or two of medium wedge-shaped pad C and long wedge-shaped pad D used together with the present invention and additionally square pillow F are combined to use. (1) FIG. 17A shows an example of use combined with FIG. 3C, and medium wedge-shaped pad C and long wedge-shaped pad D doubly stacked. (2) FIG. 17B shows an example of use combined with FIG. 4 D and long wedge-shaped pad D doubly stacked. (3) FIG. 17C shows an example of use combined with FIG. 5 C and long wedge-shaped pad D doubly stacked and additionally square pillow F. (4) FIG. 17D shows an example of use combined with FIG. 4C, and medium wedge-shaped pad C and long wedge-shaped pad D doubly stacked. In Use Example 5, correction angle # turns out to be FIG. 17 A< 17 B< 17 C< 17 D. Use Example 6 Contrary to the above use in the supine position, FIGS. 6A and 6B shows an example in the prone position same as on the conventional breast pad. It can reduce anteroposterior curvatures of the spine and make it nearly a horizontal position. Example of use for FIGS. 6A and 6B are shown in FIGS. 18A and 18B, respectively. As it shows, for the height, FIG. 6A is higher than FIG. 6B, and for the base, FIG. 6B is longer than FIG. 6 A. This difference is useful for personal differences in size, etc. In the above examples of use, correction angle # is shown in normal condition. In fact, the angle varies according to the differences in size and frame. For example, in case of rounded back, when long wedge-shaped pad D is at the back, correction angle # is bigger. And according to the way of combining three types of wedge-shaped pad, the angle is not always shown accurately the degree of correction. In the above examples, the point of wedge-shaped pad contacts the center of lumbosacral region Y . Actually, in the range of lumbosacral region Y , the point of wedge-shaped pad can be moved to accord with personal differences, for fine adjustments. In addition, correction angle # can be adjusted by moving the convertible triangular pillow A , three types of wedge-shaped pad and square pillow F. Although convertible triangular pillow A and three types of wedge-shaped pad comprising a short wedge-shaped pad B , a medium wedge-shaped pad C and a long wedge-shaped D are described as treatment aids for chiropractic therapy used accompanying chiropractic therapy, these treatment aids are not used by therapist during the chiropractic therapy. Accordingly, these can be used regardless of chiropractic therapy. As stated above, treatment aids for chiropractic therapy of the present invention are used accompanying chiropractic therapy to correct anteroposterior curvatures at lumbosacral region Y . In other words, when it is used before chiropractic therapy, it can release tension of groups of muscles forming anteroposterior curvatures at lumbosacral region Y , which make it easier for chiropractic therapy. When it is used after chiropractic therapy, it can keep the corrected posture and increase the treatment effect. Furthermore, when it is used two times accompanying the therapy, we can get greater effect. And also, as treatment aids for chiropractic therapy, since the present invention has a lot of variation for combination such as using solely convertible triangular pillow A , using together with three types of wedge-shaped pad comprising a short wedge-shaped pad B , a medium wedge-shaped pad C and a long wedge-shaped D , and using optionally square pillow F , it can deal with personal differences in size and frame. Furthermore, the treatment aids for chiropractic therapy of the present invention has a simple structure, and a lot of variation for use, and what is more, it is easy to use. For that reason, the treatment aids for chiropractic therapy can be used at home by patients who are familiar with using them under instruction of therapist. In this way, wrong curvatures of the spine caused by daily life can be corrected in daily life. In addition, although the convertible triangular pillow A of the present invention has a lot of variation for use, non-slip sheet attached to it ensure stability in all use. Moreover, the convertible triangular pillow A of the present invention has a note and examples of use on its body, accordingly, users can try a lot of variation smoothly without instructions manual. Although the above examples of use described the convertible triangular pillow A of the present invention are used accompanying chiropractic therapy, these treatment aids are not used by therapist during the chiropractic therapy. Therefore, (1) it can be also used at home without chiropractic therapy after completion of treatment, and (2) it can be also used at home regardless of chiropractic therapy. Some examples of application used at home without chiropractic therapy are shown as follows. Application 1 The treatment aids for chiropractic therapy of the present invention can release tension of groups of muscles forming anteroposterior curvatures at lumbosacral region Y , and easily lead to a relaxed posture. Therefore, it allows us (1) to reduce the time to fall asleep, and (2) to reach a deep sleep. For that reason, various effects are expected for the sleep concerning effective short sleep and release from insomnia. Application 2 Since the treatment aids for chiropractic therapy of the present invention has a lot of variation for use and easily allow us to change body postures, making full use of the characteristics of it, effects for prevention and relief of pressure sore and joint contracture suffered by bedridden patients are expected. Only selected embodiments have been chosen to illustrate the present invention. To those skilled in the art, however, it will be apparent from the foregoing disclosure that various changes and modifications can be made herein without departing from the scope of the invention as defined in the appended claims. Furthermore, the foregoing description of the embodiments according to the present invention is provided for illustration only, and not for limiting the invention as defined by the appended claims and their equivalents.

1a

FIELD OF THE INVENTION The present invention relates generally to an apparatus or an article of manufacture of clothing and more particularly an article of clothing which may be converted or unfolded into a bed roll, blanket or covering. BACKGROUND OF THE INVENTION Articles of clothing providing multiple features are known in the art. U.S. Pat. No. 4,149,272 to Maeshima discloses a multi-purpose vest with a pocket suitable for containing items such as a waterproof jacket. U.S. Pat. No. 4,932,574 to Doshi illustrates a garment folded into a bundle which may be carried as a backpack. U.S. Pat. No. 5,361,412 to Perry discloses a multi-use vest with several configurations of pockets. The foregoing are provided herewith in an Information Disclosure Statement in accordance with 37 CFR 1.97. SUMMARY OF THE INVENTION The present invention discloses a jacket, vest, coat, shirt or similar clothing article which converts or unfolds into a bed roll, covering or blanket to provide sleeping support or overall body coverage and comfort. The disclosed jacket or vest is assembled with a pocket formed between a portion of the jacket, such as a jacket outer covering, and a portion of a blanket wherein a portion of the blanket is foldably received into and stored within the pocket for removal and unfolding when use of the blanket is required. The pocket thus formed may be at any location on the jacket including but not limited to the front, back and inside of the vest or jacket. The manufacture of the vest or jacket is principally a blanket or fabric unit or portion integral with the vest or jacket portion. The blanket or fabric portion is contained, by folding, in the pocket. The vest or jacket is worn and utilized as any jacket or vest garment. The integral blanket or fabric portion may be removed from the pocket and unfolded forming, with the vest or jacket portion and the primary area of the blanket or fabric, generally a blanket, comforter or other covering. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other features and advantages of the present invention will become more readily appreciated as the same become better understood by reference to the following detailed description of the preferred embodiment of the invention when taken in conjunction with the accompanying drawings, wherein: FIG. 1 is a front view of a convertible garment demonstrated as a jacket, having a jacket top and bottom, right and left sides, a neck opening and arm openings showing a sleeveless style with vertical front opening, amenable to a variety of closure devices, and collar with the blanket and pocket opening observed at the neck opening. FIG. 1A is a front view of the jacket showing a sleeveless and collarless style with the blanket and pocket opening observed at the neck opening. FIG. 2 shows the left side of the jacket partially opened. FIG. 2A shows the left side of the jacket partially opened with the pocket oriented such that the pocket is at the jacket inside and the pocket opening is proximal to the left side. Illustrated is the pocket bottom, bottom seam and left and right seam. This illustration suggests the variety of pocket orientations which are encompassed within this invention. FIG. 3 illustrates the right and left sides of the jacket in partially opened positions, a pocket opening is illustrated at the inside with the pocket bottom shown at the jacket right side at the jacket inside. FIG. 4 shows the jacket from the back showing right and left seams, a bottom seam and pocket bottom and pocket opening at the back proximal to the jacket top. FIG. 4A shows the jacket as it would appear from either the front or back showing an alternative positioning of the pocket where the pocket opening is other than positioned proximal to the jacket top. Sleeves 11 are depicted as an alternative feature. FIG. 5 commences illustrations demonstrating the steps for access to and manner of extracting and reinserting the blanket from and back into the pocket. This figure shows the blanket partially pulled out of the pocket after first reaching in through the pocket opening. This figure illustrates the pocket opening proximal to the collar front. The blanket is removed from the pocket reaching into the pocket at the pocket opening and grasping the bottom of the pocket at the pocket bottom and pulling the folded blanket through the interior of the pocket and out of the pocket opening. FIG. 6 shows the blanket layout after the pocket is completely pulled inside-out and the blanket flattened. The collar back is shown in this view. This illustration shows the blanket in a folded layer which was contained within the pocket. FIG. 7 illustrates the double folded blanket in a partially unfolded orientation. A remaining fold is seen in this view. FIG. 8 illustrates the double folded blanket in a partially unfolded orientation. A remaining double folded blanket is seen in this view. FIG. 9 shows the partial unfolding demonstrating the full-length position of the blanket which still contains folded material extending over the length of this view. FIG. 10 illustrates the unfolding of the remaining lengthwise fold displaying the blanket in its fully opened orientation. FIG. 11 shows the unfolded portion reversed and upended to demonstrate the opposite side of the view shown in FIG. 10 . FIG. 12 shows the pocket, pocket opening and blanket seams and jacket inside with the neck collar facing downward in this view; alternatively this illustrates the circumstance where a collar is folded into the pocket; alternatively this illustrates the circumstance where a pocket is formed at the front of a jacket; alternatively, this illustrates the circumstance where a pocket is formed at the jacket inside. DETAILED DESCRIPTION The Convertible Garment 1 disclosed herein is illustrated in FIG. 1 through FIG. 12 . FIG. 1 is a front view of the jacket 1 showing a sleeveless style with vertical front opening 5 , amenable to a variety of closure means including but not limited to for example, VELCRO®, zippers, buttons and snaps and other closure means, and collar 8 with a blanket 12 observed at neck opening 19 . The jacket 1 has a right and a left side 22 , 20 . The collar 8 has a collar front and a collar back 9 , 10 . The collar 8 is shown in FIGS. 1 through 4, 5 through 8 and 11 . The collar front 9 is shown in FIGS. 1 through 4 and 5 while the collar back 10 is shown in FIGS. 6 and 11. The left side 20 of the jacket 1 is shown partially opened in FIG. 2 . FIG. 3 illustrates the right and left sides 22 , 20 of the jacket 1 in partially opened positions. FIG. 3 also shows the blanket 12 of the jacket 1 . FIG. 4 shows the jacket 1 from the back 40 with left and right seams 45 , 47 illustrating or indicating a portion of the jacket 1 structure forming the perimeter or boundary of a pocket 35 formed between the back 40 and the blanket 12 . The pocket 35 has a pocket opening 37 positioned, for example in the preferred embodiment, proximal to the collar 8 at the collar front 9 , as shown in FIGS. 1 through 2A, 11 and 12 , and a pocket bottom 39 positioned distal from the pocket opening 37 , as shown in FIGS. 1 through 5 and 11 and 12 . The blanket 12 forms a portion of the pocket 35 as is shown in FIGS. 1 through 5 and 9 through 12 . The blanket 12 is additionally folded into and contained within the pocket 35 . The blanket 12 in the preferred embodiment is composed of a double folded layer of blanket material. However, the blanket 12 may be composed of many different fabrics or materials including but not limited to, for example, canvas and fire resistant materials, plastics and reflective materials including but not limited to mylar, blanket stock and other materials recognized by one of ordinary skills in the garment arts. In an alternative embodiment the pocket opening 37 may be positioned proximal to the collar 8 at the collar back 10 , at the jacket inside and at the jacket side. The jacket 1 may be in a vest, jacket or coat form, with or without collar or sleeves. A jacket shell or other outer garment or an inner lining may be utilized. The pocket opening 37 will be amenable to a variety of fastening or closure means including but not limited to VELCRO®, zippers, buttons and snaps and other closure means devices or methods. The pocket 35 may be oriented so that the pocket opening 37 is positioned in a multitude of orientations including, as examples without limitation, proximal to the jacket top or bottom 17 , 18 , proximal to the right or left 22 , 20 , diagonal to a vertical from the jacket top to bottom 17 , 18 at the front or back 3 , 40 or inside 26 . FIG. 5 is illustrative of an arm and hand having partially pulled the blanket 12 out of the pocket 35 after first reaching in through the pocket opening 37 proximal to the collar 8 at the collar front 9 . The blanket 12 is removed from the pocket 35 to reveal and present a fabric or material covering. The blanket 12 is removed from the pocket 35 by inserting hands into the pocket opening 37 and grasping, at the inside of the pocket, the pocket bottom 39 . The blanket 12 is extracted from the pocket 35 after extending one's arm fully into the pocket 35 via the pocket openings 37 and pulling the blanket 12 from the pocket 35 . FIG. 6 shows the blanket 12 in a double folded form where the blanket 12 is completely extracted from the pocket 35 and flattened in the preferred folded configuration of this embodiment. FIG. 6 also illustrates the collar back 10 and the blanket 12 which was contained within the pocket 35 . FIG. 7 illustrates the blanket 12 in a partially unfolded orientation. A remaining fold 14 is demonstrated in FIG. 7 . FIG. 8 shows what was depicted as a remaining fold 14 , in FIG. 7, unfolded into the full-length of the blanket 12 which remains, in FIG. 8, partially folded. FIG. 9 illustrates a remaining lengthwise fold 16 . FIG. 10 displays the blanket 12 in the position where the pocket 35 has been turned inside-out revealing additionally the pocket bottom 39 and the left and right seams 45 , 47 . FIG. 11 is a view of the blanket 12 extracted from the pocket 35 with the pocket 35 turned inside-out and bounded by the left and right seams 45 , 47 , the pocket opening 37 , the pocket bottom 39 and the jacket back 40 . FIG. 11 shows the opposite side of jacket 1 from that shown in FIG. 10 . FIG. 11 additionally demonstrates the collar 8 facing downward revealing the collar back 10 . FIG. 12 shows the collar 8 folded into the pocket 35 at the pocket opening 37 . The jacket 1 is returned to a jacket form by reversing the process described. The folded orientation of the blanket 12 in FIG. 6 demonstrates the position for reinsertion of the blanket 12 into the pocket 35 to return to the form of a jacket. The jacket 1 is returned to the jacket 1 form by reaching through the pocket opening 37 into the pocket 35 and grasping the pocket bottom 39 and drawing the folded blanket 12 into the pocket 35 as the pocket 35 is again turned inside-out to the position demonstrated by FIGS. 1 through 4 . The convertible garment is comprised in the elemental sense of a garment, shown here for convenience as a jacket 1 , with a blanket 12 affixed by means to the jacket 1 , forming a pocket 35 ; the blanket 12 affixed to the jacket such that portions of the blanket 12 are foldably received into the pocket 35 . The jacket 1 may have a liner or a shell, be collar or collarless, sleeve or sleeveless and possess other commonly understood structures in the garment arts. The blanket 12 may be of regular geometric shapes including but not limited to square, rectangular and circular or irregular shapes. The blanket 12 , for convenience, is described as having a blanket top and bottom 13 , 14 , a blanket right and left edge 15 , 16 and a centerline 42 extending generally centrally from blanket top to blanket bottom 13 , 14 ; the blanket 12 is affixed to the jacket 1 generally by stitching with other commonly understood affixing means appropriate including but not limited to VELCRO®, snaps, buttons, brads, glues and other affixing means. The blanket 12 is affixed to the jacket 1 in a variety of orientations including at the jacket back 40 , front 3 and inside 26 . The blanket 12 is affixed to the jacket 1 such that portions of the blanket 12 will be folded and received into the pocket 35 at the pocket opening 37 . The blanket 12 may be affixed to the jacket 1 intermediate to the blanket right edge 15 and the centerline and intermediate to the blanket left edge 16 and the centerline and proximal to the blanket bottom 14 forming a pocket having a pocket opening proximal to the blanket top 13 and distal to the blanket bottom 14 which foldably receives, at the pocket opening 37 , those portions of the blanket 12 positioned between the affixing means and the blanket right and left edges 14 , 15 and between the pocket opening 37 and the blanket top 13 . The jacket 1 has an outer covering 2 , a front and a back 3 , 40 , a jacket top and bottom 17 , 18 ; a jacket inside 26 ; the jacket 1 at the front 3 has a right and a left side 22 , 20 ; and a neck opening 19 at the jacket top 17 . The blanket 12 may be affixed by means to the jacket outer covering 2 at the back 40 , at the front 3 and at the inside 26 . Another description of the orientation of the blanket and jacket is found in the description of the blanket 12 as affixed by means to the jacket 1 by left and right seams 45 , 47 and a bottom seam 48 ; the bottom seam 48 is generally orthogonal to the left and right seams, which are generally parallel, and intersecting the left and right seams 45 , 47 ; the left and right seams 45 , 47 and the bottom seam 48 fasten by affixing means to the blanket 12 to the jacket 1 forming the perimeter or boundary of a pocket 35 , the pocket 35 having a pocket opening 37 and a pocket bottom 39 positioned distal from the pocket opening 37 and the bottom seam 48 . Again, the blanket 12 may be affixed by means to the back 40 , front 3 and inside 26 . Alternatively the left and right seams 45 , 47 are generally vertically formed commencing proximal to the jacket top 17 and proceeding proximal to the jacket bottom 18 ; the bottom seam 48 is generally horizontally formed proximal to the jacket bottom 18 at the back 40 intersecting the left and right seams 45 , 47 ; the left and right seams 45 , 47 and the bottom seam 48 fasten by means the outer covering 2 at the back 40 to the blanket 12 forming the perimeter or boundary of a pocket 35 residing between the back 40 and the blanket 12 ; the pocket 35 having a pocket opening 37 positioned proximal to the jacket top 17 , and a pocket bottom 39 positioned distal from the pocket opening 37 proximal to the jacket bottom 18 and the bottom seam 48 ; the blanket 12 is folded into and contained within the pocket 35 . The blanket 12 may be affixed by means to the front 3 , the back 40 and/or the inside 26 . In all events, the blanket 12 is folded into and contained within the pocket 35 when the jacket 1 is used and is otherwise unfolded and used as a blanket 12 . It will be recognized by one of ordinary skill in the garment arts that the affixing pattern, above described as right and left seams 45 , 47 and a bottom seam 48 , may form other patterns including but not limited to “U” shaped and semicircular. The affixing means in the preferred embodiment is stitching. However other affixing means will suffice including but not limited to, VELCRO®, zippers, buttons, snaps, brads, glues and other affixing means recognized by one of ordinary skill in garment arts. The jacket 1 may have a collar 8 , at the neck opening 19 , having a collar front and a collar back 9 , 10 ; arm openings 23 proximal to the jacket top 17 at the right and left sides 22 , 20 ; the outer covering 2 at the front 3 may have a center front opening 5 from the neck opening 19 to the jacket bottom 18 ; the center front opening 5 amenable to a variety of jacket closure means including but not limited to VELCRO®, zippers, buttons and snaps and other closure means devices or methods. The pocket 35 may be positioned to place the pocket opening 37 proximal to the collar 8 at the collar front or back 9 , 10 or proximal to the jacket top 17 at the front or back 3 , 40 or inside 26 . The pocket 35 may alternatively be oriented to place the pocket opening 37 toward the right or left 22 , 20 or in other orientations. In any event, the blanket 12 is folded and inserted into and contained within the pocket 35 . The method of converting the garment of claim 7 comprises inserting a hand through the pocket opening 37 into the pocket 35 ; grasping, at the inside of the pocket, the pocket bottom 39 ; turning the pocket 35 inside-out revealing additionally the pocket bottom 39 and the left and right seams 45 , 47 ; extracting the blanket 12 from the pocket 35 ; unfolding the blanket 12 . The reverse returns the blanket 12 into the pocket 35 including folding the blanket 12 , reaching through the pocket opening 37 into the pocket 35 and grasping the pocket bottom 39 ; drawing the folded blanket 12 into the pocket 35 as the pocket 35 is again turned inside-out to the starting position. Alternative embodiments apply to this invention, as would be recognized by those of ordinary skill in the garments art, to articles of clothing other than jackets including for example, without limitation, overcoats, pants and trousers. The matter of the application of a pocket foldably containing a blanket or other covering is equally applicable to other articles of clothing other than upper jacket type apparel. While a preferred embodiment of the present invention has been shown and described, it will be apparent to those skilled in the art that many changes and modifications may be made without departing from the invention in its broader aspects. The appended claims are therefore intended to cover all such changes and modifications as fall within the true spirit and scope of the invention.

1a

CROSS REFERENCES TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 12/353,759, filed Jan. 14, 2009, which claims priority to commonly owned U.S. Provisional Patent Application Ser. No. 61/021,228, entitled: Camouflage For Day And Night Use, filed Jan. 15, 2008, the disclosures of which are incorporated by reference in their entireties herein. TECHNICAL FIELD The disclosed subject matter is directed to camouflage, and articles that are camouflaged. In particular, the disclosed subject matter is directed to camouflage for articles with camouflage patterns incorporating reflective materials into the patterns, such that the article is of a camouflage pattern by day and is reflective at night or other periods of darkness. BACKGROUND Camouflage is well known to the animal and human kingdoms. Many species of animals are naturally camouflaged to blend into their surroundings as a defense against predators. Camouflage has been used for centuries to conceal the user from humans, animals and the like. Today, as in the past, camouflage finds its greatest uses in military and hunting applications. For example, in hunting, hunters typically wear clothes with one or more camouflage patterns to blend in with the surroundings, so as not to be visible by the animals being hunted. Typical camouflage patterns for hunting employ splotches of brown, black and green in different shades with splotches of whites, grays and lighter greens throughout the pattern. Other camouflage patterns are designed to mimic those of a forest, woods or trees. For example, camouflage patterns mimicking natural foliage are sold under the names Real Tree® and Mossy Oak®. As a result of this camouflage, game animals, typically deer, see the camouflaged hunter as a three dimensional object that is part of the forest or woods, rather than as another animal or potential threat. For example, FIG. 1 shows a conventional hunting camouflage garment. This garment is a shirt 10 printed with a camouflage pattern. As prime hunting times are at dusk, when day is turning to night, and at dawn, when night is turning to day, hunter safety is critical in darkness. While the camouflage is effective during periods of light, it presents a hazard during low light conditions, when hunters may be moving, but are not hunting. Although hunters wear blaze orange clothing to be visible to other hunters, motorists, or other passers by, especially during hours of darkness, the blaze orange clothing is detectable by animals. This diminishes the value of the camouflage that must be covered in the blaze orange, to increase safety. Also, even if the hunter removes the blaze orange articles of clothing, he still must carry it, creating an unnecessary burden. SUMMARY The present disclosed subject matter provides for camouflage articles that serve as camouflage during daylight, allowing the user to blend in to his surroundings, and provide reflection to light, for example, visible light, such as from lamps, lights, vehicle headlights, flashlights, floodlights and search lights, and the like, during night, darkness, or other periods of low light (e.g., dawn and dusk) for safety. The reflective portions are part of the actual camouflage pattern, such that the camouflage pattern appears unaltered on the article. The reflective portions are formed of reflective ink or other reflective material, that forms a part of or all of the portion or element (portions and elements of the camouflage pattern are used interchangeably herein) of a color, in the camouflage pattern. The reflective material, such as reflective ink, also contributes to the deception effect, as viewed by animals, such as deer, as produced by the camouflage pattern. Specifically, the reflective ink in the camouflage pattern alters the depth of field as viewed by the animal, further enhancing the effectiveness of the camouflage. The disclosed subject matter includes a camouflage pattern. The pattern includes a plurality of portions, each portion including a color selected from at least two different colors, at least one portion being of a color different than the color of at least one other portion, and at least one color is formed of reflective material, e.g., reflective ink. The camouflage pattern may be on an article and the article may be, for example, garments, such as shirts, pants, gloves, scarves, hats, caps, headbands, coats, jackets and underwear. The disclosed subject matter is also directed to camouflage articles. The articles include a plurality of portions, each of the portions being of one color selected from at least two different colors, and at least one portion or a part thereof includes reflective ink corresponding to the color of the at least one portion. The articles may be, for example, garments, clothing, headwear, footwear and the like, such as shirts, pants, gloves, scarves, hats, caps, headbands, coats, jackets and underwear. Another embodiment is directed to a camouflage article including a plurality of portions, each of the portions being of one color selected from at least two different colors. At least a part of the at least one portion is reflective in the color corresponding to the color of the at least one portion. The at least two colors is more than two colors. Another embodiment is directed to a camouflage article. The article includes a camouflage pattern formed of a plurality of elements, at least a portion (part) of each element of either of a first or second color, with at least a portion (part) of an element of the first color being of a reflective material. Another embodiment is directed to a method of making a camouflage article. The method includes providing an article, and providing at least a part of the article with a camouflage pattern formed of multiple portions or elements, at least one portion or element of a first color and at least one portion or element of a second color, the first color different from the second color, and at least one portion or element of the first color or the second color of a reflective material. The article may be, for example, garments, fabrics, materials, apparatus and the like. BRIEF DESCRIPTION OF THE DRAWINGS Attention is now directed to the drawing figures, where like or corresponding numerals or characters indicate corresponding or like components. In the drawings: FIG. 1 is a drawing of a camouflage garment in accordance with the prior art; FIGS. 2A and 2B are drawings of front and rear views of a camouflage garment in accordance with the disclosed subject matter; and, FIGS. 3A and 3B are drawings of exemplary camouflage patterns in accordance with the disclosed subject matter. DETAILED DESCRIPTION FIGS. 2A and 2B show a garment or article, for example, a camouflage shirt 20 imprinted with a camouflage pattern. The camouflage pattern is formed of various colors, dark colors such as brown, black, dark green, and lighter colors, and all variations in hue thereof, such as light green, gray, white, and all variations in hue thereof. For example, the colors are in the form of portions or elements that form the camouflage pattern. These portions or elements are, for example, of a single color. Also, for example, the portions or elements may be splotches, that are arranged amongst other splotches or over a base matrix, to form the requisite camouflage pattern on the article. For example, one or more of the lighter colors (all or a part thereof of the portion or element of that particular color in the camouflage pattern), may be of a reflective material, for example, reflective ink (also known as retro-reflective or retroreflective ink). The reflective ink is reflective to light (e.g., visible light, such as that from lamps, lights, vehicle headlights, flashlights, floodlights and search lights) that contacts it, at night or during other dark and partially dark or low light periods. For example, all or part of the elements (portions of the pattern) of a light color, such as the elements of a white color 22 (shown as shaded for explanation purposes) may be colored by a white reflective ink. The remaining colors of the garment (e.g., in elements or portions of the camouflage pattern), for example, gray, light green, dark green, brown and black, may be of conventional inks, dyes, pigments or the like. Similarly, in a camouflage pattern 30 , 30 ′, shown in FIGS. 3A and 3B , respectively, useful on the articles mentioned herein, one or more colors, in their respective potions, or parts thereof, of the pattern 30 , 30 ′ may be of reflective ink in the respective color. For example, in the pattern 30 of FIG. 3A , the gray portions 32 (shown as shaded for explanation purposes) of the pattern 30 are in gray reflective ink (along with portions of white 34 , light green 36 and dark green 38 , for example, of conventional ink, dye, coloration or pigment), while in the pattern 30 ′ of FIG. 3B , the gray 32 and white 34 portions of the pattern (both shown as shaded for explanation purposes) are in gray and white reflective ink, respectively. The light green 36 and dark green 38 portions are, for example, of conventional ink, dye, coloration, or pigment. While the lighter colors are typically in reflective ink, any of the other colors, including the darker colors of the camouflage pattern (for example, one or more of the darker colors), and combinations of the lighter and darker colors, may be in reflective ink. This may be for the entire potion of the color or just a part of the portion (element), as detailed above. The reflective ink may be, for example, gray reflective ink such as Safety Gray Reflecto reflective ink from One Stroke Inks of Louisville, Ky., and Product 8010 of Series 8000 Reflective Ink for Textiles, from 3M, St. Paul, Min. 55144. Other suitable inks include white reflective ink, such as Product 8015 of Series 8000 Reflective Ink for Textiles, from 3M, St. Paul, Min. 55144. Additional suitable reflective inks include, for example, other inks of the Series 8000 Reflective Ink for Textiles, from 3M, St. Paul, Min. 55144. Still other exemplary inks include Aquasoft® 407LF Reflective Base and 409LF Reflective Ink, from International Coatings, Cerritos, Calif. 90702, Optilux™ 505 ink and Optilux™ Ultra Max reflective ink, from International Coatings, Cerritos, Calif. 90702, and Reflec 200 retro-reflective screen inks, from Sericol Limited, Kent CT.10 2LE, England, all pigmented to the color desired. While the reflective ink is shown in a random arrangement according to the camouflage pattern, the reflective ink may also be printed onto the article in the respective portion (in the same or different colors) so as to form a pattern, word or word groups, geometry, symbol, object, form, figure, other recognizable indicator, or the like. The reflective ink is, for example, used for the entire potion (entire element) of the assigned color of the camouflage pattern, but could also be used for a part of the portion (element) of the assigned color of the camouflage pattern. The reflective ink is applied to the article, apparatus, etc., as part of the camouflage pattern, by techniques such as screen printing, hot split transfer, flexography, lithograph, off-set curable, rotary screen, gravure, photocopy, thermography, dye-sublimation, laser printing, ink-jet printing, digital printing, electrostatic applications, embossing, engraving, air-brushing, and the like. While the disclosed camouflage is shown on articles such as clothing, and garments, including shirts, pants, gloves, scarves, hats, caps, headbands, coats, jackets and underwear. It is also usable on headwear, such as hats and caps, footwear, such as shoes, boots, and the like, and other articles, such as luggage, motor vehicles, fabrics, tarps, tents, service wear, such as plates, cups, glasses, cooking utensils, buildings, and portions thereof, such as walls, roofs, doors, windows, awnings, canopies, building materials, aircraft, ships, furniture, such as tables and chairs, and any other article that is suitable for being camouflaged. While preferred embodiments of the disclosed subject matter have been described, so as to enable one of skill in the art to practice the present disclosed subject matter, the preceding description is intended to be exemplary only. It should not be used to limit the scope of the disclosed subject matter, which should be determined by reference to the following claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates in general to farming machines intended for preparing the soil and has specific reference to a rotary machine of this type which is capable of crushing manure and mixing or harrowing the soil preliminary to seeding operations. 2. Description of the Prior Art Rotary machines for preparing the stubble having hitherto been designed according to the current harrow practice. These rotary machine are operated as a rule at rotational velocities of the order of 250 r.p.m. and therefore the mulch, grass and residual hay on the soil surface are simply mixed with the earth without being crushed, so that their decay takes a relatively long time. SUMMARY OF THE INVENTION This invention is especially directed to a rotary machine capable of crushing both green manure and stubble during a first phase and to subsequently mix up the crushed manure with the earth, so that the ensuing decay takes place much more rapidly before the seeding operation. To perform these different operations, the machine should have two speed ranges, i.e. a first or low range of the order of 250 r.p.m. for mixing the soil and a second or high range of the order of 1,000 r.p.m. for crushing the green manure and stubble; besides, the machine should be capable of revolving in either direction, namely in the direction of travel of the machine for mixing the soil and in the opposite direction for the preliminary crushing of manure. To meet these requirements, the machine according to the present invention comprises two opposite hitching systems designed the one for the harrowing function and the other for crushing the manure, each hitching system being associated with a separate power input member for rotatably driving the tool carrier shaft. Therefore, the machine comprises two opposite hitching systems and two power inputs also opposed to each other, whereby the desired opposite directions of rotation can be obtained while keeping the same rotation direction of the tool-carrier in relation to the machine frame, in one or the other circumstance of utilisation. This arrangement is advantageous in that it allows to use, as well for the mixing work as for the crushing work, the same cutting edge of the tools. As to the different velocities of rotation, they are obtained by simply interchanging two pinions of two lateral gear trains for transmitting the torque from the power or driving shaft to the tool carrier shaft. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a vertical longitudinal section showing a preferred embodiment of the machine according to this invention hitched to the rear of a towing tractor; FIG. 2 is a fragmentary plan view from above showing more particularly the mechanism for transmitting the torque to the tool carrier shaft, and FIG. 3 is a diagrammatic, simplified view of one of the lateral gear trains, as seen from the outside. DESCRIPTION OF THE PREFERRED EMBODIMENT The manure-crushing and earth-mixing rotary machine according to this invention comprises a main frame 1 and a pair of lateral carrier wheels 2; this machine is adapted to be hitched to a tractor 3 by means of a conventional three-point attachment comprising a pair of lower side rods 4 and a single upper central rod 5 connected to the top bearing pin 6 of the machine. The lower rods 4 are adapted to be pivotally connected to either of two pairs of hitching pins 7, 8 fixedly carried by the machine: one pair of pins 7 is disposed on one side of the machine, the other pair of pins 8 being disposed on the opposite side, as clearly shown in FIG. 2. The crushing and mixing tools or blades 9 are carried by a carrier assembly having a transverse shaft 10 provided at its ends with side pinions 11 meshing with driving pinions, as will be explained presently. In the assembly illustrated in the drawing the lower rods 4 are connected to hitching pins 7 and the driving pinions meshing with pinions 11 consist of toothed wheels 12 rigid with adjacent pinion 13 meshing in turn with toothed power wheels 14 keyed or otherwise fastened to transmission half-shafts 15, 16 operatively connected through bevel gears 17, 18 to longitudinal stub shafts 19, 20 rotating in opposite directions and at the same speed, these stud shafts 19, 20 being interconnected by meshing pinions 21, 22 respectively. The stub shaft 19 comprises at its end nearest to the pair of hitching pins 7 a splined or like power input portion 23 adapted to be drivingly coupled to the power take-off of the tractor through a cardan drive shaft 24 for crushing the mulch, stubble or green grass, by rotatably driving the tool carrier at high speed in a direction opposite to the direction of travel of the tractor. At its opposite end, the stub shaft 19 is operatively connected via a train of reversing gears 25, 26 to another longitudinal stub shaft 27 constituting the power input member for the mixing operation during which the tool carrier is rotated in the direction of travel of the tractor and at a lower rotational velocity. The mode of operation of this machine will be clearly apparent from the above description to those skilled in the art; however, it will be explained more in detail hereinafter, with reference firstly to the transmission path providing the fast rotation of the tool carrier shaft 10 when the hitching is through pins 7, as shown in the drawing. The arrows of FIGS. 1 and 2 show merely the shafts rotating constantly in the same direction with respect to the frame of the machine (though changing this direction of rotation with respect to its direction of travel). The cardan drive shaft 24 drives the stub shaft 19 through the power input portion 23 thereof, and this shaft 19 drives in turn the half-shaft 15 through bevel gears 17 and half-shaft 16 through pinions 21 and 22, shaft 20 and bevel gears 18. The half-shafts 15, 16 rigid with the driving toothed wheels 14 are in constant meshing engagement with pinions 13, thus driving the latter as well as the toothed wheels 12 rigid therewith and meshing in turn with the wheels 11 of the tool carrier shaft 10, whereby this shaft 10 will rotate at a higher speed (overdrive) with the transmission ratio provided by gears 14, 13, 12 and 11, and in a direction opposite to the direction of travel of the machine for performing the mulch and stubble crushing operation. To perform the subsequent soil mixing operation, the machine is hitched to the tractor through the other pack of pins 8 and the drive is provided through the opposite power input 27. The torque is thus transmitted via pinions 26, 25 to stub shaft 19 which, in relation to the frame 1, will still rotate in the direction of the arrow, as shown, but this time in the direction of travel of the tractor pulling the machine from the opposite side. To obtain a lower speed, it is only necessary to interchange the toothed wheels 14 and 13; in other words, the half-shafts 15 and 16 are rigid with pinions 13 and drive the wheels 14 rigid with pinions (not shown) meshing with gear wheels 11. Thus, assuming for instance that the diameter of wheels 14 is twice that of pinions 13, it is clear that the meshing between 14 and 13 will step up the angular velocity in the ratio of 2:1 for the crushing operation and step down this velocity in the same ratio for the mixing operation which will therefore take place at a velocity four times lower than the preceding angular velocity. It will be readily understood that the above-described form of embodiment illustrated in the accompanying drawing should not be construed as limiting the scope of the invention, since many modifications and changes may be brought thereto without departing from the basic principles of the invention as set forth in the appended claims.

1a

BACKGROUND OF THE INVENTION This invention relates to overhead merchandise displays for use in retail establishments, and more particularly to an overhead cigarette pack merchandiser which can be adjusted to accommodate the particular heights of individual store personnel. Overhead merchandise displays are well known in the retailing field, particularly for use with small items and especially those which are available in a large variety of sizes or brands. Located above the counter of a retail store, these displays help prevent theft, because the items are accessible only to the store clerk. At the same time, the clerk need not divert his eyes from the rest of the store while selecting the item requested. The displays also encourage impulse buying by displaying fast-moving, high-profit items to the customer while he waits for service. These units are generally supported by columns from below, or by columns or chains from the ceiling. They are open only at the rear, facing the sales clerk, while the front and sides, which are closed, can carry advertising which may, for example, indicate to customers the type of merchandise within. Alternatively, the front and side panels may be fully or partly transparent, affording the customers a view of the contents. These two features can be combined, so that the panels are partly transparent, with the non-transparent portion bearing advertising. Hooks can be provided on the exteriors of the side and front panels for hanging other types of merchandise often bought on impulse. For example, one type of overhead cigarette display in use is supported by posts from either above or below. The front side, facing the customers, carries backlit advertising transparencies for various cigarette brands, surrounding a lighted clock or other customer-attracting feature. Cigarettes are held in wire mesh drawers within the enclosure, accessible to the clerk from the rear. The drawers are positioned at an angle, so that each time a pack is removed a new one is fed by gravity to the position vacated by the first pack. The drawers are mounted on standard track and glide mounts, such as those used in filing cabinets, which allow them to slide down for easy stocking. Another known type of overhead cigarette merchandising display is supported by posts from below. In this display, cigarettes are stored in a succession of vertical magazines mounted on tracks or glides for vertical movement. Each magazine comprises several columnar sub-magazines which dispense cigarette packs from the bottom. As a pack is removed, the remaining packs in that column shift downward, so that another pack takes the place of the one removed. The bottom of each successive vertical magazine is lower than that of the one before it, with the magazine closest to the clerk the highest. By virture of this stepped arrangement, the clerk has access to the bottom of each column without moving any of the magazines. The height of each "step" is such that several packs of each brand are visible. The magazines can be reloaded by lowering them on their tracks, allowing access to the tops of the columns. Both the front and rear panels of the display can carry advertising. A third known type of overhead merchandise display is supported by chains from above. The cigarette packs are stored in columns which are gravity-fed as described above in connection with the second type of display. The side facing the customer can be completely transparent, or can be fitted with one of a number of additional merchandising aids. One such aid could be manufacturer's advertising, or a "reader board" on which the storekeeper can display any desired message such as special sales, seasonal messages, or menus (in the case of a foodservice counter). Another available merchandising aid with which the exterior panels can be equipped is a pegboard on which other items often bought on impulse, such as photographic film, razor blades, batteries and other items, can be displayed. Both of these aids leave a portion of the transparent panel visible so that the customer can see the brands of cigarettes that are available. These overhead displays have not proven to be completely satisfactory. First, they are all generally box-like in appearance, and are not especially attractive even after the addition of sometimes elaborate electrified advertising. Second, and more important, they lack the necessary degree of height adjustability. In selecting the height at which an overhead merchandising display is mounted, there are two competing considerations. One is that the unit should be low enough that the shortest clerk who will be staffing the counter can reach it without undue discomfort. The other is that it should be high enough that the tallest clerk can see under it clearly, without stooping. The height of many of the conventional units described can be changed, but only by coarse, discrete adjustments which require at least partial disassembly of the unit, and are usually made, in practice, only at the initial installation. SUMMARY OF THE INVENTION It is an object of this invention to provide an overhead cigarette merchandising display the height of which is easily and continuously adjustable to accommodate the varying heights of store personnel. It is a further object of this invention to provide such an adjustable display which has an attractive and distinctive appearance. It is still another object of this invention to provide such a display which is as simple to construct and operate as possible. The present invention comprises an overhead retail merchandising unit for cigarettes which has an elongated cigarette dispensing enclosure which is closed on its top, bottom, sides, and front, and open at its rear. The unit is supported by upright posts which are slidably received in upright passages in the enclosure. Means are provided in the enclosure for translating it relative to the upright supports and for retaining it at the desired height once adjusted. The supports are additionally capable of coarse height adjustments to a limited number of discrete positions. Other objects and advantages of the invention will become apparent to one skilled in the art upon reading the following detailed description with the accompanying drawings, in which like reference characters refer to like parts throughout. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front perspective view of the overhead cigarette merchandising unit of the present invention; FIG. 2 is a rear elevational view of the overhead cigarette merchandising unit of the present invention; FIG. 3 is a cross-sectional view of the overhead cigarette merchandising unit of the present invention, taken along line 3--3 of FIG. 2; and FIG. 4 is a cross-sectional view of the overhead cigarette merchandising unit of the present invention, taken along line 4--4 of FIG. 2. DESCRIPTION OF THE PREFERRED EMBODIMENT A preferred embodiment of the overhead cigarette merchandising unit of this invention is illustrated in FIGS. 1 through 4. The unit, indicated generally at 101 in FIG. 1, is shown mounted on counter 102. The unit is supported by upright posts 103, 104 attached to respective cross-pieces 105, 106. Telescoping extensions 107 of the cross-pieces provide greater stability, but can be retracted to reduce bulk during shipment or other movement of the unit. Uprights 103, 104 are braced at the top by cross-beam 108. The main body of the unit is enclosure 109, shown in its uppermost position, and shown also in phantom at 110 near its lowermost position. The enclosure has a front panel 111, which faces the customers, a top panel 112, a bottom panel 113, a left side panel 114, and a right side panel (not shown). Front panel 111 can carry advertising or other messages, as indicated generally at 115. The rear of enclosure 109 is shown in FIG. 2. Top panel 112, shown here in greater detail than in FIG. 1, is seen to be composed of three panels 201, 202, 203, separated by ribs 204, 205. The enclosure is seen to contain, in this embodiment, nine cigarette pack trays 301-309, shown more clearly in FIG. 3. Each tray shown has nine channels 206 for receiving rows of cigarette packs. Each channel illustrated has a capacity of fourteen packs 310, for a total capacity for the unit shown of 81×14=1,134 packs of cigarettes. At the front of each channel is thumb notch 207, which facilitates the removal of a cigarette pack 310 in the manner shown at 311. Trays 301-309 are supported on a shelf-like framework indicated generally at 312. The rear of each tray in the upper and middle rows (trays 301, 302, 304, 305, 307 and 308) rests on upper cross-member 313 or 314, respectively, while the rear of each tray in the bottom row (trays 303, 306, and 309) rests against member 323 of framework 312. As can be seen in FIG. 3, the trays are supported in an inclined position, with the front of each tray resting on one of the lower cross-members 315, 316, 317. Triangular stops 318 depend from the front of the bottom of each tray, retaining the tray against sliding out of the enclosure by engagement with the respective lower cross-member for that tray. The inclination of trays 301-309 provides gravitational feed of the cigarette packs. As a given pack is removed, as indicated at 311, the remainder of the packs in that channel slide downward so that a new pack takes the place of the one that was removed. When a channel is empty, it is easily restocked by lifting the tray by means of handle 319 so that triangular stop 318 is moved out of engagement with the lower cross-member. The tray can then be lifted completely out of the enclosure for restocking, or can be drawn down to the position shown in phantom at 320. In the event the latter option is selected, the rear of the tray rests on the lower cross-member during restocking, with safety stop 321, which depends from the rear of the bottom of the tray, engaging the cross-member to prevent accidental slippage of the tray out of the enclosure. One of the primary advantages of the cigarette merchandising unit of this invention is its adaptability to varying height requirements, as dictated by both space limitations and personnel height. To provide adjustability to the physical limitations of a particular installation, uprights 103, 104 can be fashioned from telescoping members such as box beams and provided with retaining means (not shown) so as to be capable of discrete height adjustments. Further, if necessary, they can be mounted so that the unit can be suspended from the ceiling, although floor or counter mounting is preferred. For finer height adjustment in daily use after installation, such as at a shift change when the clerk on duty may be replaced by another of different height, a mechanism is provided allowing simple and convenient alteration of the height of the unit. The mechanism is illustrated in detail in FIG. 4, which is a cross-sectional view of the interior of the right end cap 401 of enclosure 109. An identical mechanism is found in the left end cap. The end cap is provided with ribs 402, 403 defining a passage 404 through which upright 104 passes. To minimize friction, passage 404 is made wider than upright 104, and is provided with spacers 405, 406, 407 to maintain upright 104 in proper alignment. A gear rack 408 is provided on the rear face of upright 104 for engagement with pinion gear 409, which is journalled adjacent to passage 404. A similar rack and pinion arrangement is found on the left side of the unit at 116. The respective pinion gears 409 are joined by an interconnecting shaft 322 which passes through shelf cross-member 316, as shown in FIG. 3. Shaft 322 is fixedly connected to each of the pinion gears 409 so that the gears rotate in unison. The gears are rotated manually by crank 410, which is removable and is preferably connected to pinion gear 409 only when it is desired to operate the mechanism. Crank 410 can be connected at either end of enclosure 109, although shown in both FIG. 1 and FIG. 4 on the left side. Rotation of crank 410 in the direction shown by arrow 411 will lower the enclosure 109 to the position shown in phantom at 110, and lower, to the extent that the length of gear rack 408 will allow. Rotation in the opposite direction will raise the enclosure. Interconnecting shaft 322 is needed to insure that both ends of the enclosure move simultaneously, to prevent jamming of the unit. Means are provided to retain enclosure 409 at any height selected. These means include, first, coiled flat springs 412, 413 attached to upright 104 at 414 and 415 respectively, and wound on self-lubricating bobbins (not shown) journalled for rotation on shafts 416, 417. Springs 412 and 413, which wind and unwind inside partial shields 418, 419, along with identical springs in the left end cap attached to upright 103, are chosen to have a restoring force equal to the weight of enclosure 109 when fully loaded with cigarettes. In that way, regardless of the height selected, the weight of the unit is exactly counterbalanced by the pull of the springs, so that it remains in that position. In addition, movement of the enclosure will require only enough force to overcome the friction within the lift mechanism. However, as cigarettes are sold, and the unit becomes lighter, it will tend to rise under the influence of the springs, and downward adjustment of the height of the enclosure will require extra force to overcome the upward bias of the springs. Therefore, additional retaining means are provided in the form of locking slides 420, 421 on the left and right sides, respectively, of enclosure 109. During movement of the unit, these slides, accessible from the outside of the enclosure, are kept at the position in which slide 421 is shown in FIG. 4. After the desired height has been selected, slide 421 is moved downward along slot 422, until tongue 423 engages the teeth of pinion gear 409, preventing the rotation thereof, thereby locking the enclosure at the selected height. Slide 420 functions similarly on the left side of the enclosure. Longer enclosures can be accommodated according to this invention by providing additional upright supports at selected locations along the length of the enclosure. In such an embodiment, each such additional support should have associated with it a mechanism as described above, with all of the mechanisms linked by interconnecting shafts such as shaft 322. The preferred material for the panels of enclosure 109 is medium impact styrene plastic, although any material commonly used for retail displays will suffice. The gears and associated parts are preferably formed of acetal plastic, while the trays are preferably formed from a transparent K-resin plastic, but here again any commonly used material will function equally well. The upright supports should be able to sustain the entire weight of the unit, and should, therefore, be made of a material capable of bearing a significant load, such as stainless steel or chrome plated mild steel. The coiled springs are by their nature limited to a material of suitable strength and elasticity, such as spring steel. The cigarette merchandising display as described is versatile in its adaptability to changing physical constraints. It is also attractive and distinctive in appearance, presenting a profile quite different from those of the prior art. By angling off the corners of the enclosure, unused air space that would be inside the enclosure in other displays is eliminated, presenting a less bulky appearance and allowing more light to reach the counter area. The front face of the enclosure can carry advertising or other messages, or backlit displays, or can be left blank. It will therefore be seen that this invention provides a distinctive and attractive overhead cigarette merchandising display which can be adjusted to any one of an infinite number of selected heights. It should be understood that the embodiment described herein is meant to be illustrative only, and that other adaptations are possible within the scope of the invention, which is to be limited only by the claims below.

1a

This patent application is a continuation-in-part of prior patent Application No. 09/163,698 filed Sep. 30, 1998, abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to denture adhesives and methods for making denture adhesives. 2. Description of Related Art Dentures are substitutes for missing teeth and serve as replacement for all or some of the teeth found in the oral cavity. Despite diligent efforts by dental professionals and designers of dental prostheses, dentures do not always fit perfectly. Over time, even well-fitting dentures can become ill-fitting due to natural shrinkage and changes in the gum or mucous tissues. Therefore, adherent creams, liquids or powders are often used to secure or temporarily fix dentures within the mouth. There are a number of desirable attributes of a denture adhesive composition. The denture adhesive should develop a high degree of tack upon contact with saliva so that the dentures can be held in place as soon as they are seated in the mouth. It is also highly desirable that the mucilage of the fixative be spread over the denture-mucosa interface in order to seal the denture in place effectively. The mucilage should possess sufficient cohesive strength to withstand the stresses of mastication, which act to rupture the seal and thus dislodge the denture. The denture adhesive must also exhibit sufficient resistance to degradation under the extreme environmental changes that can occur in the oral cavity during such common actions as drinking hot or cold beverages. Of course, the adhesive must also be releasable so that the denture wearer may remove the dentures for cleaning and maintenance. Denture adhesives are generally sold as a cream, liner or strip, liquid or powder, and many examples are well known in the art. Early denture adhesives contained finely ground particles of natural gums that expanded when wet with water to become a viscous gel, which acted as a cushion and an adherent between the denture plate and the gum tissue. These denture adhesives, however, have been largely supplanted by polymeric denture adhesives in recent years. U.S. Pat. No. 3,003,988 to Germann discloses a mixed partial salt of a methyl vinyl ether/maleic acid (or maleic anhydride) copolymer ("PVE/MA") as a denture adhesive. This mixed partial salt may be a calcium salt combined with a monovalent sodium, potassium, or quaternary ammonium salt with the calcium to the monovalent cation ratio from 2:1 to 10:1 on a weight basis (on a mole ratio basis the ratio was stated to be from 1:1 to 5:1), with the polymer being from about 50-95% neutralized by the cations. The PVM/MA Ca/Na salts disclosed in examples I-V of Germann are prepared by a semi-dry process in the presence of a small amount of water and isopropanol which is insufficient to completely dissolve all of the PVM/MA anhydride and hydrolyze all of the anhydride groups to the acid form. Consequently, the equivalents of acid available to completely neutralize all of the metal hydroxides charged in making a high calcium containing Ca/Na salt by the semi-dry process in Germann are often insufficient. The result being that the PVM/MA Ca/Na salt is actually a mixture of unreacted metal hydroxides, PVM/MA Ca/Na salt, and unreacted PVM/MA anhydride which has a distinct taste associated with it. There have been many alternatives and improvements to the original Germann polymer salt. U.S. Pat. No. 5,395,867 (Prosise--assigned to ISP) uses calcium, sodium, strontium, zinc, magnesium and potassium cations to change the properties of the polymer salts. Prosise discloses a "wet process" which employs a stoichiometric excess of acid groups (90-96% water), thus assuring complete dissolution of the PVM/MA copolymer and complete hydrolysis of the anhydride groups in the PVM/MA copolymer to acid groups. Consequently, the wet process yields a Ca/Na PVM/MA salt which has better organoleptic properties than a dry or semi-dry process salt. Additionally, dental adhesive compositions produced by the wet process also show to have improved elastic properties. One important factor in designing a denture adhesive salt is consumer acceptance of the organoleptic qualities of the salts in the denture adhesive. Another factor is the ease of manufacture of the adhesive salts. A major disadvantage of the wet process in the prior art to produce organoleptically acceptable denture adhesives is the tendency of the process to produce precipitates of PVM/MA Ca/Na salt, which is particularly a problem in manufacturing PVM/MA salts with a high degree of substitution in calcium (about 69% and greater). While this precipitated PVM/MA salt appears to have no activity as a denture adhesive salt, the salt precipitates when formed in large enough quantities in the salt-making reactors can plug reactor lines and pumps used to transfer the product to dryers causing expensive maintenance and down-time. Therefore, it is not possible to make dental adhesive compositions with a high degree of substitution because of plugging problems which basically stop the manufacturing process. Prosise teaches that one of the copolymers from the copolymeric Ca/Na mixed salt are derived from is available as GANTREZ® AN, supplied by International Specialty Products (ISP, the assignee of the Prosise patent). Product literature from ISP/GAF Corporation (page 11, Gantrez® AN, technical bulletin 7543-017) discloses that the addition of calcium beyond 0.7 mol equivalents causes precipitation of Gantrez® AN. The problem can be avoided by not using more than 0.7 mol equivalents of calcium, i.e., avoiding the precipitation formed during further calcium neutralization "by replacement of calcium with caustic." The inventor has surprisingly found that denture adhesive compositions can be manufactured comprising calcium/sodium PVM/MA salts formed via a wet process with the level of calcium beyond 0.7 mol equivalents. It is found that it is NOT necessary to avoid the precipitation, i.e., manufacturing problems by avoiding the addition of calcium beyond 0.7 mol equivalents. Contrary to the prior art teaching of "replacement of calcium with caustic," the addition of calcium well beyond the 0.7 mol equivalents (70% degree of substitution) is possible by controlling the amount of sodium and/or potassium hydroxide employed in producing calcium/sodium and/or potassium PVM/MA salts in the wet process. There is also provided in the invention a denture adhesive paste comprising a mixed partial calcium/sodium or calcium/potassium salt of a PVM/MA wherein the degree of substitution of the copolymer in calcium is at least about 69%. SUMMARY OF THE INVENTION The invention provides a denture adhesive composition comprising a wet-process partial, mixed salt of a copolymer of an alkyl vinyl ether and maleic acid produced by a wet process, wherein the cations of said salt comprise: i) calcium with a degree of substitution of the copolymer in calcium is at least about 69%; and ii) at least one other cation selected from the group consisting of sodium and potassium. In a preferred embodiment of the invention, the degree of substitution of the copolymer in calcium is in the range of about 69-80% and the degree of substitution of the other cation is about 1-10%. The invention further provides a method for making denture adhesive compositions with a wet-process, partial, mixed salt of a copolymer of an alkyl vinyl ether and maleic acid, and wherein: the cations of the salt comprises: i) calcium with degree of substitution of the copolymer in calcium is at least about 69%; and ii) at least one other cation selected from the group consisting of sodium and potassium with a degree of substitution in the range of about 1-10%. DESCRIPTION OF THE PREFERRED EMBODIMENTS The principal object of the present invention therefore is to provide a denture adhesive comprising a salt of an alkyl vinyl ether/unsaturated anhydride or polycarboxylic acid copolymer with acceptable organoleptic properties and good processing properties. The denture adhesive compositions of the present invention can be formulated in liquid, cream, liner, and possibly powder forms that, when in contact with saliva, develop a high degree of tack and uniform viscous mucilages of high cohesive strength and that, when spread over the denture-mucosa interface, provide superior denture stabilizing properties. The compositions contain a denture adhesive salt together with excipients. Denture Adhesive Salt The denture adhesive employed in the composition is a partial salt of a copolymer of maleic acid and an alkyl vinyl ether (collectively referred to as "PVM/MA"). Preferably, the alkyl group has from about 1 to about 5 carbon atoms, but a more preferable copolymer includes methyl vinyl ether. As is known by those skilled in the art, the molecular weight of such copolymers can affect the properties of the copolymer and, by extension, the denture adhesive comprising the copolymer. Polymers generally do not have one precise molecular weight. Rather, polymers are made up of many polymer molecules, each having a different molecular weight. One way to measure the "average" molecular weight of a polymer is to measure its specific viscosity under specified conditions. The preferred copolymer of the invention generally has a specific viscosity (measured as a 1% weight/volume solution of methyl ethyl ketone at 25° C.) of at least about 1.5. More preferably, the specific viscosity is at least about 2.5. The preferred copolymer of the invention is generally used as its partial salt. The maleic anhydride group can be hydrolyzed to form the corresponding dicarboxylic acid which can, in turn, react with metal compounds that partially neutralize the carboxylic acid groups on the copolymer. Preferably less than 100% of the carboxylic acid groups on the copolymer chain are neutralized. More preferably, about 26% to about 15% of the carboxylic acid groups are left unneutralized of the copolymer and most preferably from about 24% to about 15% of the carboxylic acid groups. One of the cations in accordance with the invention is calcium. Another cation in accordance with the invention is an alkali metal cation, preferably sodium and/or potassium. As indicated before, it has been suggested in the prior art that the addition of the cation calcium beyond 70% degree of substitution causes precipitation of the PVM/MA copolymer, thus making it impossible to manufacture the Ca/Na salt composition. It has also been suggested that the calcium be replaced by caustic. Instead of replacing calcium with sodium and/or potassium as suggested in the prior art, it has been surprisingly found that the problematic Ca/Na PVM/MA salt precipitate formation can be eliminated even with high levels of calcium substitution (69% or greater) by holding the substitution level of the other cation, i.e., sodium and/or potassium within certain limits. The substitution level of the other cation is preferably kept at a decreasing level with increasing level of substitution of calcium. More preferably, the substitution level of the other cation is kept within the range of about 1 to 10%. Most preferably, the substitution level of the other cation is kept approximately within the following range with respect to the degree of substution in calcium: TABLE 1______________________________________Most preferred embodiment - degree of substitution of Ca:Na Degree of substitution - Ca Degree of substitution - Na______________________________________69% 1-10% 71% 2-8% 73% 2.5-8% 75% 3-6% 77% 4-5.5% 80% 4.5-5.5%______________________________________ Other Ingredients The dental adhesive compositions of the present invention may further comprise a water-soluble cellulosic polymer as is known in the art such as methyl cellulose, sodium carboxymethyl cellulose, hydroxyl propyl methyl cellulose and the like. The cellulosic polymer, preferably sodium carboxymethyl cellulose, is a powder which when moistened, becomes hydrated and tacky or gummy thereby providing additional adhesive functionality to the dental adhesive composition. The sodium carboxymethyl cellulose gums are water-soluble, anionic long chain polymers whose properties vary to some extent depending on the number of carboxymethyl groups that are substituted per anhydroglucose unit in each cellulose molecule. These cellulose polymers comprise from about 15% to about 35%, and preferably from about 17% to about 28% of the dental adhesive composition. The denture adhesive may also comprise an activator such as a polyacrylic acid, polycarbophil, citric acid, sodium or calcium citrate and/or a polymeric acid such as a Gantrez® acid. Preferably, the activator comprises a polymer, such as relatively short chain resins and longer polymers, copolymers, graft or block copolymers, and linears or network polymers. Such materials can be naturally-occurring or derived or entirely artificial. Preferred materials include chelating polymeric acids and salts. Preferred chelating acids and salts comprise copolymers of dicarboxylic materials such as methyl-vinyl ether/maleic acid copolymers and acrylic acid/maleic acid copolymers. Preferably, the lower alkyl vinyl ether-maleic acid is present in an amount of about 0.1% to about 1.5% by weight based on the total weight of the denture adhesive composition. More preferably, the lower alkyl vinyl ether-maleic acid is present in an amount of about 1% by weight based on the total weight of the denture adhesive composition. Excipients Typical excipients include waxes and oils. Other excipients often included in denture adhesives include flavoring agents, sweetening agents, viscosity modifiers, coloring agents, preservatives and thickeners. Other water soluble polymers such as xanthan gum, polyvinyl pyrrolidone (PVP), carboxymethyl cellulose, methyl cellulose and hydroxyl propyl guar may also form part of the final denture adhesive formulation. Vehicles such as petrolatum, mineral oil, vegetable oil and the like may form part of cream-type formulations, and non-toxic anti-caking agents such as silica, talc, dicalcium phosphate anhydrous and the like can be present. The compositions can also contain, if desired, other known denture adhesives. The oils useful in the invention include without limitation is mineral oil. However, vegetable oils such as corn, soybean, cottonseed, castor, palm and coconut oils and animal oil such as fish oil may also be used in addition to mineral oil. In general, amounts of oil from about 1% to about 30% by weight of the total denture adhesive composition are usable, with amounts of about 10% to about 25% being preferred. The colorants useful in the present invention include pigments such as titanium dioxide, and may also include the lakes of dyes suitable for food, drug and cosmetic applications. These colorants are known as D&C dyes. Two preferred colorants are the lakes of D&C Red No. 7 and D&C Red No. 30. Fumed silica can also be used as a thickener for the adhesive. A fine white powder, fumed silica is the colloidal form of silica (silicon dioxide, SiO 2 ) made by the combustion of silicon tetra-chloride in a hydrogen-oxygen furnace. The amount of fumed silica used in the composition may range from about 0.7% to about 2%. Preparation The denture adhesive composition of the invention can be prepared by mixing the components until a homogeneous mixture and is obtained and recovering the resulting product. For example, if polyethylene and mineral oil are to be employed, such material may be heated to temperatures from about 90 to 95° C., and are preferably cooled prior to blending with other components such as the polymeric acid and coloring agents. Whether formulated as a powder, liner, liquid or cream, the denture adhesive composition of the present invention hydrates to form an adhesive composition when applied to moist dentures or exposed to water or saliva. In order to further illustrate the present invention, various illustrative examples are set forth below. In these examples, as well as throughout the specification and claims, all parts and percentages are by weight and all temperatures in degrees Celsius unless otherwise specified. EXAMPLES 1-2 Polymer salts were prepared in the following manner. 900 g of room temperature water were charged into a main reactor kettle equipped with a high speed stirrer. The anhydrous MVE/MA copolymer was slowly added to the main mix kettle with continuous mixing. 250 g of room temperature water were charged into a secondary kettle and either sodium hydroxide or potassium hydroxide and calcium hydroxide were added slowly. This slurry was well mixed to form a homogenous slurry. The slurry was slowly added into the main reactor kettle while mixing at high speed to prevent localized precipitation. The batch was heated to 85° C. (±5° C.) and maintained at about 85° C. for two hours with vigorous mixing, forming the salt. These salts remained in solution and did not precipitate or settle thus ruining the batch. The resulting mixture was put in trays and dried at 85° C. in an oven or dried on a drum drier. The dried Ca/Na, or Ca/K 75/5, 80% degree of substitution salt was then milled through a suitable mill and screened through a 60 mesh screen. A one percent solution of the resulting powder had a pH of about 5.5-6.5 and a bulk density of 0.7-0.8. The materials used and the amounts used are set forth in Table 2. These salts did not precipitate or settle. TABLE 2______________________________________Formulation of Examples 1 and 2 Ingredient Example 1 Example 2______________________________________Water 1150 g 1150 g GANTREZ ® AN169 72.38 g 72.79 g Calcium hydroxide 25.77 g 25.90 gSodium hydroxide 1.82 g --Potassium hydroxide -- 2.6 g______________________________________ COMPARATIVE EXAMPLE A polymer was made according to example 1, except that an amount of sodium hydroxide was employed that was sufficient to form a Ca/Na 75/8, 83% degree of substitution salt. After the mixer was turned off, a heavy deposit of precipitate was observed on the bottom of the glass reactor and the batch had to be discarded. The purpose of the above description is to illustrate some embodiments of the present invention without implying a limitation. It will be apparent to those skilled in the art that various modifications and variations may be made in the apparatus or procedure of the invention without departing from the scope or spirit of the invention.

1a

BACKGROUND [0001] Endotracheal intubation is a common procedure in the field of respiratory medical care. Endotracheal intubation tubes are used in many situations for providing artificial airways for passage of respiratory gasses and medical procedure devices to patients. For instance, endotracheal tubes may be used to insert a catheter therethrough in order to clean lung secretions from a patient. Endotracheal tubes may be used in situations where patients have stopped independent breathing and are required to be supported on a ventilator. In addition, endotracheal tubing may be used for other procedures such as: oxygenation of the lungs; elimination or reduction of residual carbon dioxide from the lungs; visual inspection of portions of the respiratory system; sampling sputum and gasses; measuring parameters such as flow rates, pressure, and temperature of gasses within the respiratory system; and/or the administration of medication, gasses, and/or lavage. [0002] All of these procedures require various instruments to be used in conjunction with the respiratory circuit. In addition, other equipment may be incorporated into the circuit. For example, some respiratory circuits include a humidifier. Humidifiers are advantageous because breathing gasses supplied to a patient must be warm and humidified in order to provide quality inhalation therapy. A humidifier is typically connected in the breathing circuit between the ventilator and the patient. Air from the ventilator is warmed and moisturized by the humidifier and then is supplied to the patient. Due to the fact that various instruments and pieces of equipment must be connected and reconnected to the respiratory circuit, connectors are often employed in such circuits. [0003] Connectors are often permanently bonded to instruments and manifolds in respiratory circuits. This type of attachment is advantageous because a secure and fluid-tight fit is provided. However, permanently bonding an instrument or other piece of equipment in a respiratory circuit has inherent disadvantages. For instance, an instrument that is permanently bonded to a connector cannot be removed therefrom and must be replaced oftentimes increasing the cost of the medical treatment. Further, permanently bonding a diagnostic instrument to a connector may prevent the clinician from performing some other type of procedure on the patient during ventilation of the patient. Additionally, damage of an instrument or piece of equipment that is permanently bonded to a connector may necessitate the replacement of several components of the respiratory circuit. [0004] Connectors which are detachable have been used in order to overcome the problems associated with permanently bonded connectors in respiratory circuits. A detachable connector allows for various instruments and pieces of equipment to be interchanged in a respiratory breathing circuit. As such, the respiratory breathing circuit can be configured to provide for an increased number of procedures. Additionally, the ability to remove instruments from the breathing apparatus may allow for the instrument to be cleaned, hence reducing the costs associated with the procedure. [0005] However, problems with disconnect medical connectors do exist. Typically, such connectors are interference-fit connectors. For instance, a fitting on a catheter may be connected to a complimentary fitting on a manifold of a respiratory breathing circuit by forcing one fitting onto the other. The catheter is then held onto the manifold via an interference fit between the two fittings. Since the connection is not a permanent connection, air or other fluids may leak through this interference-fit connection. Additionally, if the fittings of interference-fit connectors are not adequately pressed against one another, forces could act on the connection to accidentally disconnect the connection. Obviously, such a result is unacceptable. Also, multiple fittings which are connected together via an interference fit may sometimes be difficult for a doctor or caregiver to disconnect when it is necessary to remove the surgical instrument. One example of an interference-fit connector is shown in U.S. Pat. No. 5,820,614. [0006] The present invention improves the general type of medical connectors currently employed, and further addresses the need in the medical field for an improved medical connector for use with a respiratory breathing circuit. SUMMARY [0007] Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention. [0008] The present invention provides for a connection assembly that is used with a respiratory circuit assembly. The connection assembly includes a cylindrical first connection member that has a bore therethrough. The first connection member is configured for engagement with a first respiratory circuit member and allows for transport of fluids and objects therethrough. The first connection member has a locking member that is located thereon for engagement with a second connection member to prevent disengagement between the first and second connection members. In one embodiment, this locking member includes a recess on one end of the first connection member. A portion of the recess defines at least one ramp on the first connection member. [0009] A second connection member is present that has a cylindrical body with a bore therethrough. The second connection member allows for the transport of fluids and objects therethrough, and is configured for engagement with a second respiratory circuit member. The second connection member has a disconnect member with a curved surface at least where the disconnect member is located in the recess during engagement between the locking member and the first connection member. Relative rotation between the first connection member and the second connection member causes the curved surface to move along the ramp. This effects disengagement of the locking member and the first connection member, and causes separation of the first and second connection members. [0010] The present invention also includes a connection assembly as immediately discussed where the disconnect member is a cylindrical irrigation port. [0011] Further, the present invention includes a connection assembly as previously discussed where the locking member includes a locking ring that substantially surrounds the circumference of the first connection member. The locking ring is located proximate to the recess of the first connection member. The second connection member has a groove for engaging the locking ring and acting with the locking ring to prevent disengagement between the second connection member and the first connection member. [0012] The present invention also includes a connection assembly as immediately discussed where the disconnect member has at least part of the surface being curved where the disconnect member engages along the ramped surface. [0013] Further included in the present invention is a connection assembly as previously discussed where the disconnect member is a substantially cylindrical irrigation port. [0014] Further included in the present invention is an exemplary embodiment as previously discussed where the locking member is at least one barb located on one of the first and second connection members. [0015] In one embodiment of the connection assembly, a snap fit member is present on at least one of the first and second connection members. The snap fit member hinders unintentional disengagement of the first and second connection members. Relative movement between the first connection member and the disconnect member motivates a separation of the first and second connection members. [0016] Further included in the present invention is an exemplary embodiment as previously mentioned where the snap fit member is at least one barb located on the second connection member. [0017] Additionally, the present invention includes an embodiment as previously discussed where the snap fit member is a locking ring that substantially surrounds the first connection member. The second connection member has a groove for receiving the locking ring to hinder disengagement of the first and second connection members. BRIEF DESCRIPTION OF THE DRAWINGS [0018] An embodiment of the present invention is described by way of example with reference to the accompanying drawings, in which: [0019] [0019]FIG. 1 is a bottom plan view of an exemplary embodiment of a first connection member in accordance with the present invention. The drawing shows two ports located on a rotatable manifold. [0020] [0020]FIG. 2 is a cross-sectional elevation view of an exemplary embodiment of a connection assembly in accordance with the present invention. The drawing shows a first connection member engaged with a second connection member by use of a locking member. [0021] [0021]FIG. 3 is a cross-sectional elevational view of an exemplary embodiment of the second connection member in accordance with the present invention. The drawing shows a barb located on one end of the second connection member. [0022] [0022]FIG. 4 is a cross-sectional elevation view of an exemplary embodiment of the first connection member in accordance with the present invention. The drawing shows the rotatable manifold having two ports with locking members on both of the ports. [0023] [0023]FIG. 5 is an elevation view of an exemplary embodiment of a first connection member in accordance with the present invention. The drawing shows a recess defining a ramp on one end of the first connection member and proximate to the locking member. [0024] [0024]FIG. 6 is a cross-sectional elevation view of an exemplary embodiment of a first connection member in accordance with the present invention. The drawing shows a rotatable manifold having two ports with locking members and recesses on both of the ports. DETAILED DESCRIPTION [0025] Reference will now be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, and not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still a third embodiment. It is intended that the present invention include these and other modifications and variations. [0026] An exemplary embodiment of a connection assembly 10 is shown in FIG. 2. The connection assembly 10 includes a first connection member 12 that is engaged with a second connection member 14 . The connection assembly 10 is designed to include both a positive locking engagement between the first and second connection members 12 and 14 along with a way of disengaging the locking arrangement by rotating the first and second connection members; 12 and 14 relative to one another. Such an arrangement is advantageous because the connection assembly 10 will only be disengaged when desired by a user, and not disengaged by accident. Additionally, relative rotation between the first and second connection members 12 and 14 provides for a way of disengaging the connection assembly 10 without requiring a user to exert substantial force. [0027] The first connection member 12 is shown in FIG. 2 as being a rotatable manifold 34 . The rotatable manifold 34 may be incorporated into a respiratory circuit in order to permit access to the respiratory circuit through various ports. The rotatable manifold 34 shown in FIG. 2 has two ports 36 and 38 located thereon. In other exemplary embodiments of the present invention, the rotatable manifold 34 may be supplied as the first connection member 12 with a varying number of ports located thereon. Additionally, other exemplary embodiments of the present invention include a first connection member 12 that has only one port located thereon. A rotatable manifold 34 is known from U.S. Pat. No. 5,735,271 which is assigned to the assignee of the current application and is incorporated herein for all purposes in its entirety. The rotatable manifold 34 allows for the access of the respiratory circuit by a medical caregiver through different ports which may be sized and configured to accept various medical instruments and fluids. Other exemplary embodiments exist where the connection assembly 10 is not incorporated with a rotatable manifold 34 , but incorporated with other components of the respiratory circuit. [0028] Shown engaged with the first connection member 12 in FIG. 2 is the second connection member 14 . The connection between the first and second connection members 12 and 14 is effected by a groove 32 and locking member 16 . The locking member 16 is located on one end of port 38 of the first connection member 12 . The locking member 16 is simply a projection that extends substantially around the circumference of the port 38 . Groove 32 is located substantially around the circumference of a section of the second connection member 14 . The groove 32 and the locking member 16 are sized in such a way that engagement between the two causes a “snap-fit” connection. This connection prevents the first and second connection members 12 and 14 from separating from one another during normal use of the respiratory circuit. Therefore, the connection assembly 10 will not become disengaged during normal use, and will only become disengaged when desired by a medical caregiver. [0029] [0029]FIG. 1 is a bottom plan view of a first connection member 12 being a rotatable manifold 34 with two ports 36 and 38 located thereon. A first opening of the connection member 22 and a second opening of the first connection member 23 are located through ports 36 and 38 . These openings 22 and 23 allow for the transport of fluids and medical devices into and out of the respiratory circuit. It is to be understood that in the present application, the word “port” is defined to be a member that has an opening therethrough. Both the opening and the member can be of any shape. The member is configured to allow for the passage of fluids and/or medical devices to and from the respiratory circuit. [0030] [0030]FIG. 3 shows an exemplary embodiment of a second connection member in accordance with the present invention. Here, a barb 40 is located on one end of the second connection member 14 . The barb 40 is designed to engage a barb locking surface 42 of the first connection member 12 as shown in FIG. 4. In this exemplary embodiment, insertion of the second connection member 14 into the opening of the first connection member 22 causes the barb 40 to be compressed. Once the barb 40 clears the length of the first opening of the first connection member 22 , the barb 40 snaps into place onto the barb locking surface 42 . This in effect causes a positive locking connection between the first and second connection members 12 and 14 . This arrangement can be thought of as a “snap-fit” connection. The use of a barb 40 to effect the locking of the connection assembly 10 may be substituted for or used in addition to the use of a locking member 16 in combination with a groove 32 to effect the locking of the connection assembly 10 . As such, exemplary embodiments of the present invention may include exemplary embodiments that include only a barb 40 , a locking member 16 , or both locking member 16 and barb 40 . Additionally, other exemplary embodiments of the present invention may include members that form a positive locking arrangement between the first and second connection members 12 and 14 that are known in the art. [0031] In order to disengage the first connection member 12 from the second connection member 14 , a disconnect member 26 is provided. The exemplary embodiments shown in FIGS. 2 and 3 show a disconnect member 26 that is a irrigation port 30 having a cylindrical surface 28 . In other exemplary embodiments of the present invention, only a semi-cylindrical surface 28 is present. Additionally, other exemplary embodiments of the present invention include a disconnect member 26 that has only a partially curved surface. Also, the disconnect member 26 does not have to be an irrigation port 30 , but may simply be a lug or other member. An advantage of using the irrigation port 30 as the disconnect member 26 is that the irrigation port 30 may be used for another function such as the introduction of lavage into the respiratory circuit. [0032] [0032]FIG. 5 shows an exemplary embodiment of the first connection member 12 in accordance with the present invention. More particularly, FIG. 5 shows a recess 18 being located on one end of a port 38 of the rotatable manifold 34 . Recess 18 is curved in order to receive the cylindrical surface 28 of the second connection member 14 of FIG. 3. Additionally, recess 18 in FIG. 5 defines a ramp 20 . In the exemplary embodiment shown in FIG. 5, ramp 20 extends to the end of the port 38 . The locking member 16 is a locking ring that substantially surrounds port 38 , but does not completely surround port 38 . The locking member 16 is interrupted in the vicinity of the recess 18 . During engagement between the first and second connection members 12 and 14 , the disconnect member 26 is inserted into the recess 18 , and seats against the port 38 . Recess 18 is sized and shaped in order to accept the cylindrical surface 38 of the irrigation port 30 . Groove 32 is fit around the locking member 16 and the combination of the two securely holds; the first and second connection members 12 and 14 against one another. [0033] To disengage the connection assembly 10 , a user will rotate the first and second connection members 12 and 14 with respect to one another such that the disconnect member 26 is pushed against the ramp 20 . The cylindrical surface 28 of the irrigation port 30 is then urged against ramp 20 and moves against ramp 20 . This movement results in a force that has a component in the direction of arrow A in FIG. 5. This force then causes the locking member 16 to be disengaged from the groove 32 and allows the first connection member 12 to be removed from the second connection member 14 . [0034] As such, the exemplary embodiment shown in FIG. 5 has a first connection member 12 that is disengaged from the second connection member 14 upon clockwise rotation of the second connection member 14 with respect to the first connection member 12 . However, other exemplary embodiments of the present invention exist where the ramp 20 is positioned opposite to the position shown in FIG. 5 such that the first connection member 12 is disengaged via counterclockwise rotation of the second connection member 14 . In addition, other exemplary embodiments exist where the recess 18 defines two ramps 20 on the port 38 of the rotatable manifold 34 . Here, a user can disengage the first and second connection members 12 and 14 by rotating them relative to one another in either direction. [0035] [0035]FIG. 6 shows another exemplary embodiment of the present invention where a first connection member 12 has two ports 36 and 38 both having a locking member 16 and a recess 18 defined on one end. As such, the connection assembly 10 may be included in all of the ports of the rotatable manifold 34 and not only on a single port of the rotatable manifold 34 . [0036] Additionally, the fit between the first and second connection members 12 and 14 may be tight enough in other exemplary embodiments of the present invention such that a seal is formed between the first and second connection members 12 and 14 . A taper may be provided on one of the connection members 12 and 14 to effect this seal in other exemplary embodiments. [0037] It should be understood that the invention includes various modifications that can be made to the exemplary embodiments of the medical connector for a respiratory circuit as described herein as come within the scope of the appended claims and their equivalents.

1a

FIELD OF THE INVENTION The invention relates to devices and methods for delivering a therapeutic solution, and more specifically to a steerable needle and a method for delivering an angiogenic substance into a beating heart. BACKGROUND OF THE INVENTION There have been numerous recent advances in therapies such as angioplasty and coronary bypass surgery, which are now commonly used in the treatment of ischemic heart disease. There still exist a significant number of patients for whom these conventional therapies are not feasible options in a number of circumstances. For example, conventional coronary bypass surgery is not a treatment option in patients with diffuse small vessel coronary artery disease due to the small size and large number of diseased vessel segments. Further, re-occlusion of a diseased vessel may occur despite multiple angioplastic procedures or bypass surgeries. One promising alternative treatment for ischemic heart disease is the delivery of angiogenesis-promoting substances to the heart tissue to induce angiogenesis. Angiogenesis is a complex biological process that results in the growth of new blood vessels within tissue. Angiogenesis is an essential process common to several normal and pathologic conditions including embryologic development, wound healing, development of neoplasms, and the like. Angiogenesis involves the disruption of vascular basement membranes, migration and proliferation of endothelial cells, and subsequent blood vessel formation and maturation. Angiogenesis has also been induced in heart tissue for reperfusion of tissue compromised by myocardial ischemia. Several growth factors or mediators are known to elicit angiogenic responses, and administration of these mediators promotes revascularization of ischemic tissues. These growth factors are typically proteins which stimulate endothelial cell reproduction in the target tissue. Vascular endothelial growth factor (VEGF) is one of the most specific of the known angiogenic mediators due to localization of its receptors almost exclusively on endothelial cells. Receptors for VEGF are upregulated under ischemic conditions. Accordingly, the administration of VEGF augments the development of collateral vessels and improves function in peripheral and myocardial ischemic tissue. Delivery of VEGF remains a significant challenge. The half-life of VEGF is very short. Accordingly, the tissue must be exposed to the growth factor for a period of days. The administration of high doses of VEGF, however, is associated with hypotension. The systemic administration of VEGF can induce angiogenesis in tissues other than that which has been targeted, such as occult tumors, or sensitive diseased organs, such as the retina. This promiscuous induction of angiogenesiscan cause blindness, increase the aggressiveness of tumor cells, and lead to a multitude of other negative side-effects. Accordingly, the growth factor should be limited to the target tissue. The growth factor can be delivered to the target tissue through the use of indwelling catheters over a period of time. A preferred method of delivering the growth factor, however, is in the form of gene transfer, for example, by a replication deficient adenoviral vector containing the transgene coding for the growth factor. Under this method, a quantity of the adenoviral vector having the desired genetic component is delivered to the treatment area by injection in solution. In the past, an open-chest procedure has been used to deliver the treatment solution. According to this procedure, the patient's chest is opened surgically to expose the heart. The solution containing the adenoviral vector is then delivered to the heart tissue by using a syringe to make a number of injections in a grid-like pattern, with the surgeon keeping track of the location of each injection. International Patent Application WO 98/32859 discloses a method of enhancing the level of perfusion of blood to a target tissue during such procedure. Once injected, the adenoviral vector causes the cells in the target tissue to produce the desired growth factor, and this growth factor production of the treated cells will continue for a period of time. Previous studies have shown the feasibility and efficacy of safe, sustained, and localized expression of angiogenesis-promoting growth factors utilizing adenoviral-mediated gene transfer therapy. It is desirable to be able to provide the above described therapy without the necessity of performing open-chest surgery on the patient. U.S. Pat. No. 5,997,509 discloses an injection apparatus and method for providing gene therapy treatment to the heart or other internal organs without necessitating such open heart surgery. A procedure for utilizing a device also is disclosed in International Patent Application WO 99/44656. According to the procedure, the patient's lung is partially collapsed to enable access to areas of the heart. The therapeutic substance may be injected into the patient's myocardium by passing the needle directly through the patient's pericardium. The device disclosed in the '509 patent and International Patent Application WO 99/44656 includes an elongate flexible tubular body having a hollow needle mounted at the distal end for delivery of the therapeutic substance to the tissue. This and other currently available devices have relatively complex designs, and, accordingly, are extremely expensive to manufacture. Further, they may be difficult to manipulate around the contours of the heart or to ensure stability of the needle against the target cardiac tissue. Additionally, access to the target cardiac tissue is often obscured by other organs and tissues. One or more retractors may be used in order to physically move the obscuring organs or tissues in order to gain access to the cardiac tissue. A grasping type of retractor, a mechanically expandable retractor, an inflatable retractor, or another type of retractor known in the art may be utilized as disclosed, for example, in International Patent Application WO 99/44656. In reoperative patients, however, lung tissue frequently adheres directly to the cardiac tissue. Under these conditions, the lung and cardiac tissues cannot typically be separated by conventional methods without damage to either or both of the organs. As a result, retraction devices such as those disclosed in the '509 patent and International Patent Application WO 99/44656 are not readily utilized under such circumstances. BRIEF SUMMARY OF THE INVENTION The present invention provides a method and a minimally invasive injection device which is steerable such that it may be maneuvered into a desired position for administering an injection. The device includes a hollow needle which is adapted for connection to a solution supply. The needle has an elongated flexible body with a sharpened tip at its distal end for penetration into tissue. The needle may be steered by means of a steering cable and a moveable steering sleeve. The steering cable is an elongated cable or wire which is coupled to the needle toward its distal end and extends substantially the length of the needle to its proximal end. The user may exert a tensioning force on the steering cable to cause the elongated flexible body of the needle to flex or arch along a flexion radius. The moveable steering sleeve is slideably disposed along the elongated flexible body with the steering cable extending through the steering sleeve. Accordingly, by moving the steering sleeve axially along the needle, the user can adjust the flexion radius of the needle. That is, the needle body will be substantially straight from its proximal end up to and including the section extending through the steering sleeve. As a tension force is exerted on the steering cable, however, the needle body distal the steering sleeve will flex or arch, moving the needle tip toward the proximal end of the needle. The steering sleeve may be slid along the needle by means of a sufficiently rigid steering sleeve adjustment cable, which likewise extends toward and can be operated from the proximal end of the needle. Thus, the device provides a simplified, steerable needle arrangement that may be efficiently and economically produced. A device constructed according to teachings of the invention can be easily controlled and efficiently maneuvered within a body cavity, the flexible needle contouring to cardiac and thoracic geometry to properly position the needle tip and administer the injection. Accordingly, the device may readily be utilized in minimally invasive procedures to deliver angiogenesis-promoting substances from a remote location to an area of ischemic heart tissue without necessitating open-chest surgery. The delivery of the therapeutic substance to the myocardium can be by way of any suitable route, transpericardially, as well as endocardially. While the device may be utilized during open-heart surgery, or advanced into the heart through any artery, including, for example, the femoral artery, the device may also be utilized in the manner disclosed in International Patent Application WO 99/44656. More specifically, the patient's lung may be partially collapsed by the introduction of gas into the patient's thoracic cavity. This enlarges the working area for injection of the therapeutic substance and increases access to heart tissue. According to other features of the invention, various methods of delivering a therapeutic substance are disclosed. One such method includes the steps of inserting an elongated device body into a body cavity through an opening, and using the steering cable, and the steering sleeve adjustment cable and steering sleeve to steer the body distal end within the cavity. Another method further includes the steps of inserting the device into the patient's thoracic cavity through an opening the patient's chest wall, passing a needle into the heart tissue and delivering the therapeutic substance. Further, the needle may be passed directly into the chest cavity in a true percutaneous technique wherein no incision is made. Under these circumstances, the opening in the chest is limited only the diameter of the device or a small trocar. Inasmuch as access to cardiac tissue is often limited in re-operative patients, however, the invention further includes a methods of administering the therapeutic solution when lung tissue adhering to the heart obscures access. According to the method, the needle is passed directly through the patient's lung tissue and into the heart tissue. According to another method, the device is stabilized against the tissue by means of a moveable stabilizing platform which is disposed either against the lung tissue or against the pericardium. According to one design, the stabilizing platform is spaced from the distal tip of the needle and can transit the needle tip a sufficient distance to allow the needle tip to penetrate and pass through the lung tissue, and to penetrate the heart tissue to a desired depth. The distal-most position of the movable platform is preferably the optimum cardiac tissue penetration depth. The movable platform may be retained on the needle tip by a stop along the needle tip, or any other appropriate structure or means. According to a preferred embodiment, the platform can transit the needle tip from a position approximately 5-10 mm from the distal tip to approximately 35-50 mm proximal the distal tip. In this way, the needle tip can penetrate and extend through the lung tissue, and then penetrate the cardiac tissue a desired depth to administer the therapeutic solution. According to another feature of the invention, the platform may be stopped, advanced to, or disposed at a desired position to provide the optimum cardiac tissue penetration when cardiac penetration has been confirmed via an ECG signal. An electrode is preferably located on the on the distal tip of the needle, and connected to an ECG. In this way, the surgeon can determine when the needle has penetrated the patient's myocardium and is properly positioned. Penetration of the myocardium by the needle will show as a current injury on the ECG. By way of further example, the moveable platform may be in the form of an inflatable balloon which may be inflated to a desired volume once cardiac contact has been confirmed. Inflation may be accomplished by means of a gas line extending along the length of the needle body between the platform and an appropriate gas source. The platform of this design is preferably disposed along the needle tip at a given axial position which defines the optimum cardiac penetration depth. The deflated platform may be passed through the lung tissue and then inflated adjacent the heart tissue when proper placement has been confirmed. Other platform designs such as a spring-biased platform may be provided. These and other features and advantages of the invention will be more readily apparent upon reading the following description of a preferred exemplified embodiment of the invention and upon reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a delivery device constructed in accordance with teachings of the invention in conjunction with a syringe. FIG. 2 is a perspective view of a needle assembly of the delivery device of FIG. 1 . FIG. 3 is a perspective view of the needle of FIG. 2 wherein a tensile force has been applied to the steering cable. FIG. 4 is a plan view if the needle of FIG. 2 similar to FIG. 3 wherein steering sleeve is alternately positioned and a tensile force has been applied to the steering cable. FIG. 5 is a plan view of a patient's chest showing the organs therein and various instruments positioned for a minimally invasive procedure. FIG. 6 is an enlarged fragmentary view showing the needle constructed according to teachings of the invention penetrating the lung and heart tissue. FIG. 7 is an enlarged plan view of a third embodiment of the invention, a portion of the components being shown in cross-section. FIG. 8 is a fragmentary view of the device of FIG. 7 wherein the platform is inflated. FIG. 9 is an enlarged plan view of an alternate embodiment of the invention, a portion of the components being shown in cross-section. FIG. 10 is a cross-sectional view of the device of FIG. 7 taken along line 10 — 10 in FIG. 9 . FIG. 11 is a fragmentary, partial cross-sectional view of the device of FIG. 9 wherein the platform adjustment sleeve is moved to advance the platform along the needle tip. While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. On the contrary, the intent is to cover all alternatives, modifications, and equivalents included within the spirit and scope of the invention as defined by the appended claims. DESCRIPTION OF THE PREFERRED EMBODIMENT There is shown in FIG. 1 a delivery device 12 constructed in accordance with teachings of the invention for use in delivering a therapeutic solution to the tissue of a heart, especially a beating heart. The device 12 includes a needle assembly 14 adapted to be coupled to a syringe or other solution supply device 15 . The distal end of the needle assembly 14 is designated generally as 16 and the proximal end is designated as 18 . The needle assembly 14 includes an elongated body or cannula 20 with a sharpened needle tip 22 at its distal end. In the embodiment illustrated, the needle tip 22 is of a smaller diameter than the needle body 20 . A bore 24 extends through the needle assembly 14 and is in communication with the solution supply device 15 . During use, the device 12 may, for example, be inserted through a thoracoscopic port (not shown), giving thoracoscopic access to the patient's heart. The therapeutic solution may then be injected from the solution supply device 12 through the bore 24 of the needle assembly 14 directly into the cardiac tissue in a predetermined quantity. In the currently preferred embodiment of the invention, the solution supply device is a conventional syringe 15 . The syringe 15 includes a hollow cylindrical body 30 having a distal necked-in end 32 . A plunger shaft 34 with a plunger 36 mounted on the distal end thereof and a thumb button 38 mounted to the proximal end thereof is slidably disposed within the cylindrical body, the plunger extending outward from the body. During use, the operator may actuate the plunger 36 by depressing the plunger thumb button 38 to deliver the therapeutic solution. The needle assembly 14 may be coupled to the syringe 15 by any appropriate coupling 39 . In the currently preferred design, a metal hub 39 is utilized which has a large bore for receiving the distal necked-in end 32 of the syringe 15 . The hub 39 further includes a smaller bore which communicates with the large bore and the bore 24 of the needle assembly 14 to establish fluid communication between the syringe 15 and the needle tip 22 for delivery of therapeutic fluid. While the solution supply device has been explained with regard to a syringe 15 , it will be appreciated by those of skill in the art that the supply device can be of any appropriate design. Additionally, the supply device may include any appropriate metering device to control the amount of therapeutic substance injected at the injection site. For example, and as explained in International Patent Application WO 99/44656, the syringe 15 may include a shaft having screw threads or include a ratchet mechanism which permits the plunger button to advance within the cylindrical body only a predetermined distance to permit only a predetermined amount of therapeutic solution to be administered at a given injection site. Alternately, the administration of a controlled amount of the therapeutic solution may be facilitated by a computer controlled device. In accordance with the invention, the movement of the distal end 16 of the needle assembly 14 may be controlled by a steering mechanism (designated generally as 40 ). The needle assembly 14 and steering mechanism 40 are enlarged and schematically illustrated in FIGS. 2-4. The steering mechanism includes a steering cable 42 which is coupled to the needle body 20 at a distal attachment 44 toward the distal end 16 of the needle body 20 . The steering cable 42 extends toward the proximal end 18 of the needle assembly 14 and substantially the length of the needle assembly 14 . It will be appreciated by those of skill in the art that the assertion of a tensioning force on the proximal end 46 of the steering cable 42 flexes or arches the distal end 16 of the needle assembly 14 back towards the proximal end 18 of the needle assembly 14 along a dynamic radius of flexure as shown in FIG. 3 . It will be appreciated by those of skill in the art that the needle assembly 14 increasingly arches, that is, the radius of flexure will decrease, as the level of tensioning force on the steering cable 42 is increased. To further control this radius of flexure and the location of the bend, a moveable steering sleeve 50 is provided. The steering sleeve 50 is essentially a hollow tube having an internal bore 52 , which is disposed about the needle body 20 such that the sleeve 50 may slide axially along the needle assembly 14 , the steering cable 42 extending through the bore 52 . As may be seen in FIGS. 3 and 4, during operation, the length of the needle body 20 which remains straight and the length of the needle assembly 14 which arches is determined by the position of the steering sleeve 50 relative to the distal attachment 44 of the steering cable 42 . In this way, the radius of flexure is determined, at least in part, by the position of the steering sleeve 50 as the steering cable 42 is tensioned by the user. In order to move the steering sleeve 50 in the distal and proximal directions along the needle assembly 14 , a steering sleeve adjustment cable 54 is provided. The steering sleeve adjustment cable 54 may be of any appropriate material, so long as it is sufficiently rigid to push the sleeve 50 along needle assembly 14 . The currently preferred embodiment comprises a stainless steel cable on the order of 1-3 mm in diameter. Those of skill in the art will appreciate that the needle body 20 must be sufficiently rigid to support the steering mechanism 40 , while being sufficiently flexible to permit the needle body 20 to arch or flex as a tensioning force is applied to the steering cable 42 . Further, the needle body 40 must be sufficiently resilient such that it remains biased in a substantially straight position to permit its manipulation and use in successive injections if so desired. The needle assembly 14 portion of the device 12 will typically be approximately 300-400 mm long. A needle body 20 on the order of 20-25 Ga. has been found to be adequately flexible, yet sufficiently rigid to permit proper functioning of the steering mechanism 40 and placement of the needle tip 22 . Inasmuch as the steering mechanism 40 does not act directly upon the needle tip 22 , it is not necessary for the needle tip 22 to be as rigid as the needle body 20 . Moreover, it is preferable that the needle tip 22 be of a smaller gauge in order to facilitate penetration of the needle tip 22 into body tissue and to minimize extravasation of injectate. It has been determined that a 25-30 Ga. (e.g., 28 Ga.) cannula is particularly appropriate. While the illustrated needle tip 40 includes a bevel sharp tip 56 , it will be appreciated that an alternate tip geometry or structure may be provided. It will be appreciated that the device 12 can be readily constructed from “off-the-shelf” type components so that it may be economically manufactured. Thus, the manufacture is not cost prohibitive, and the device may be utilized as a single use, disposable device. During use, the elongated needle body 20 is inserted into the patient's body cavity through an opening. The opening in a true percutaneous technique is the opening formed by the needle assembly 14 itself as it is inserted into the chest wall and through the ribs to the heart. Under these circumstances, the opening is substantially equivalent to the diameter of the device 12 . Alternately, the needle may be inserted through a small trocar. If, for example, the device 12 has a diameter of 3 mm, the trocar might have a diameter of 5 mm. The opening might also be in the form of an airtight port 56 in the chest wall as illustrated in FIG. 5 and disclosed, for example in International Patent Application WO 99/44656. Once inserted, the needle assembly 14 is steered into the desired position using the steering mechanism 40 . That is, the physician exerts a tensile force on the proximal end 46 of the steering cable 42 , the distal end 44 of the steering cable 42 being coupled to the needle body 20 toward the body distal end 16 to steer the body distal end 16 along a flexion radius. The physician may adjust the flexion radius by locating the steering sleeve 50 at a desired position along the needle body 20 using the steering sleeve adjustment cable 52 . Once appropriately positioned, the physician can pass the sharpened needle tip 22 into the heart tissue 62 , and depressing the syringe 15 thumb button 38 to advance the plunger 36 and deliver the therapeutic substance to the patient's heart. According to another important aspect of the invention, the delivery device 12 is particularly useful when access to heart tissue is obscured by other tissue and cannot be readily separated. For example, in the procedure set forth in International Patent Application WO 99/44656, the patient's lung is collapsed or partially collapsed in order to provide working space in the thoracic cavity. In reoperative patients, however, the lung tissue 60 frequently adheres to the target heart tissue 62 , as illustrated in FIG. 6 . In accordance with the invention, the needle assembly 14 may be advanced directly through the lung tissue 60 and into the heart tissue 62 . In order to facilitate this passage, the smaller diameter needle tip 22 is sufficiently elongated to allow the needle tip 22 to penetrate and advance through the lung tissue 60 and into the cardiac tissue 62 . In this regard, the needle tip 22 is preferably on the order of 1½ to 2 inches (approximately 35-50 mm) long. It will be appreciated by those of ordinary skill in the art, however, that the needle tip 22 may be shorter or longer, as conditions warrant. In order to determine when the needle tip 22 touches or penetrates the cardiac tissue 62 , an electrode 64 similar to that disclosed in International Patent Application WO 99/44656, may be provided at the needle tip 22 , the remainder of the needle assembly 14 being insulated therefrom. Alternately, the needle tip 22 itself may serve as an electrode if the needle tip 22 is made from a conductive material. Electrical connection of this electrode 64 to an electrocardiograph (“ECG”) (schematically illustrated as 66 ) may be made by running an electrical conductor 68 along the needle assembly 14 to the ECG 66 located outside the patient's body. Standard surface ECG leads 70 are likewise applied to the patient. When the electrode 64 enters the patient's myocardium 62 (see FIG. 6 ), the event shows as a current injury. In this way, the cardiologist may ensure that the desired positioning and contact is made with the myocardium 62 prior to actuation of the solution supply device 12 . It will be appreciated that the inclusion of the electrode 64 additionally permits the cardiologist to track or electronically mark the injection sites. Accordingly, the cardiologist may follow the marking to ensure that adequate therapeutic solution is applied to the target cardiac tissue to provide optimum conditions for a desired effect. Additionally, such marking facilitates use of the needle assembly 14 in positions that are typically beyond the line of sight provided by way of a surface incision. It will be further appreciated that alternate marking means and methods may be utilized. For example, markers that may be detected ultrasonographically, radiographically, as, for example, by x-ray or catscan, or electrocardially are appropriate. Virtual marking or mapping may likewise be utilized. Such methods are disclosed, for example, in U.S. application Ser. No. 09/393,873. According to another important feature of the invention, in order to stabilize the needle assembly 14 during injection, a platform 74 is provided which contacts the surface of the lung tissue 60 or the pericardium 72 . To ensure contact of the platform 74 with the tissue and the desired stabilization, the platform 74 is moveable relative to the needle tip 22 . In the embodiment illustrated in FIGS. 5-8, the movable platform 74 is in the form of a collapsible structure. The platform 74 is preferably in the form of an inflatable and deflatable, or collapsible donut-shaped balloon coupled to the periphery of the needle tip 22 . A platform 74 on the order of 4-6 mm in diameter when fully inflated is currently considered adequate to provide desired stabilization against tissue. During insertion into the lung or other tissue 60 obstructing access to the heart 62 , the platform is fully collapsed against the needle tip 22 . In this way, the platform 74 does not interfere with the penetration of the needle tip 22 into and through the lung 60 or other tissue. Rather, the platform 74 passes through the lung 60 or other tissue. The collapsible platform 74 is particularly appropriate when the device 12 is utilized in a true percutaneous technique wherein no incision is made in the chest wall. Air or other inflating gas is supplied to the platform 74 via an air line 76 . The air line 76 extends from a source of gas at its proximal end 78 , such as from a compressed gas source or a simple syringe (not shown), along the needle body 20 and needle tip 22 , to the platform disposed generally toward the distal end 16 of the needle assembly 14 . The deflated, or collapsed, platform 74 is shown in FIG. 7, while the inflated platform is shown in FIG. 8 . The platform 74 is spaced from the distal end 16 of the needle tip 22 to limit the penetration of the needle tip 22 into the cardiac tissue. During use, the collapsed platform 74 is passed through the lung or other obstructing tissue. When the needle tip 22 has penetrated the heart tissue a desired depth, the platform 74 may be inflated to stabilize the needle along the tissue. The platform 74 is preferably inflated, as shown in FIGS. 6 and 8, at a position between the heart tissue 72 or myocardium 62 , and the lung tissue 60 . In this way, the platform 74 limits the depth to which the needle tip 22 penetrates the cardiac tissue 62 . In other words, the platform 74 is preferably spaced from the distal tip 16 of the needle tip 22 a distance equal to the desired needle penetration. It is presently anticipated that the distal surface of the platform 74 will be disposed on the order of 5-10 mm from the distal tip 45 , although alternate spacing may be dictated by factors such as the particular therapeutic solution utilized, or the physical characteristics of the tissue upon which the procedure is to be performed. In an alternate embodiment of the invention, the movable platform 80 is in the form of a disk which is axially slidable relative to the needle tip 22 , as shown in FIGS. 9-11. In this way, the platform 80 may be moved into position against the penetrated tissue at substantially any location along the needle tip 22 in order to stabilize the needle assembly 14 relative to the tissue. In contrast to the movable platform 74 of FIGS. 5-8, which moves by collapsing yet remains stationary relative to the axis of the needle tip 22 , the platform 80 of FIGS. 9-11 is movable relative to the axis of the needle tip 22 . Further, while the collapsible platform 74 is preferably disposed directly against the heart, the platform 80 steadies the needle tip 22 by placement against the first entered tissue, e.g., the lung tissue. The platform 80 may be of any appropriate shape or size and formed of any appropriate material. It has been determined that a platform 80 formed of stainless steel and on the order of 4-6 mm in diameter is particularly suitable. The platform 80 includes a central opening 82 which closely receives the needle tip 22 . In order to prevent the platform 80 from separating from the needle tip 22 , the needle tip 22 preferably includes an enlarged portion 84 . It will be appreciated that the enlarged portion 84 is slightly larger than or presents an interference with the central opening 82 of the platform 80 to prevent the platform 80 from slipping from the end of the needle tip 22 . It will further be appreciated that it is not necessary for the enlarged portion 84 to extend about the circumference of the needle tip 22 , as is shown. Rather, the enlarged portion 84 need only present sufficient interference to prevent passage of the platform central opening over the enlarged portion 84 . To facilitate proper placement of the platform 80 against the penetrated tissue, a platform adjustment mechanism 86 is provided. In the illustrated embodiment, platform adjustment mechanism is in the form of an adjustment sleeve 86 , although an alternate arrangement may be provided. The sleeve 86 is slightly larger than and axially slidably disposed about the needle body 20 . In this way, the adjustment sleeve 86 may be manually advanced toward the distal end 16 of the device 12 to contact and move the platform 80 distally and into contact with the tissue. It will be appreciated that the sleeve 86 may likewise be used to position the platform 80 toward the distal end 16 of the needle tip 22 prior to penetration into the tissue. In this way, sleeve 86 moves in the proximal direction as the needle tip 22 penetrates the tissue and the platform 80 contacts the tissue and slides proximally along the needle tip 22 . Alternately, the platform 80 may remain in a more proximal location along the needle tip 22 until the needle tip 22 has penetrated the tissue. The sleeve 86 may then be used to advance the platform 80 into contact with the tissue to steady the needle in the tissue. In order to permit the surgeon to utilize the steering mechanism 40 , the steering sleeve 50 preferably is disposed about the platform adjustment sleeve 86 , as may best be seen in FIGS. 9 and 10. In this way, the steering sleeve 50 may be advanced along the body 20 to provide the desired bending of the body 20 in conjunction with a tensioning force exerted on the steering cable 42 . Additionally, the adjustment sleeve 86 includes a slot 88 for receiving the steering cable 42 . Thus, as the platform adjustment sleeve 86 moves axially along the needle body 20 , the slot 88 moves along the steering cable 42 such that the sleeve 86 does not interfere with the use of the steering cable 42 . It will be appreciated that the platform adjustment sleeve 86 should be fabricated from a material which is sufficiently rigid that it can be pushed axially along the needle body 20 and engage and move the platform 80 , yet sufficiently flexible that it can be readily flexed as the device 12 is steered into a desired position for injection. It has been determined that a semi-rigid elastomer or rubber is particularly suitable for this application, although it is envisioned that other materials may be utilized. In summary, the invention provides a delivery device 12 that may be easily steered into a desired position and utilized for successive injections. The flexibility of the elongated needle body and the versatility of the control mechanism permit the needle to contour the path of delivery to the cardiac and thoracic geometry, providing the cardiologist great latitude in placement of the needle, and precise delivery of the injectant from a remote distance through a relatively small incision. During use, the needle is advanced into position, and the needle tip penetrates the heart tissue, either directly or through adhering lung tissue or other obscuring tissue. An electrode on the needle indicates when the cardiac tissue has been penetrated, and injection site may be marked to ensure injections occurred to desired relative locations. The platform limits the depth of penetration and allows stabilization of the needle against the epicardial surface of the heart or the surface of the lung or other tissue. The solution then can be injected into the cardiac tissue by actuating the syringe. The device is formed of readily available materials and, accordingly, may be economically constructed. All of the references cited herein, including patents, patent applications, and publications, are hereby incorporated in their entireties by reference. While this invention has been described with an emphasis upon preferred embodiments, it will be obvious to those of ordinary skill in the art that variations of the preferred embodiments may be used and that it is intended that the invention may be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications encompassed within the spirit and scope of the invention as defined by the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority of provisional application Ser. No. 60/405,367, filed Aug. 23, 2002. TECHNICAL FIELD This invention relates to deployment of endovascular stent grafts and in particular the deployment of endovascular stent grafts into lumens in the human or animal body such as into the thoracic arch region of the aorta. BACKGROUND OF THE INVENTION This specification will be discussed in relation to its application to treatment of aortic arch disease, that is to treatment in the thoracic arch of a patient but the invention is not so limited and is applicable to any lumen of the human or animal body and particularly curved lumens. Throughout this specification the term distal with respect to a portion of the aorta, a deployment device or a prosthesis such as a stent graft is intended to mean the end of the aorta, deployment device or from the heart and the term proximal is intended to mean the portion of the aorta, deployment device or end of the prosthesis nearer to the heart. For other lumens within the human or animal body the terms caudal and cranial respectively should be understood. When deploying a stent graft which is substantially cylindrical in a curved aorta there is a danger that the proximal end of the stent graft, that is the end nearer the heart, will not lie flat against the walls of a aorta and blood flow can get underneath the edge of the graft particularly on the inner side of the curve of the thoracic arch and cause the stent graft to buckle and close off thereby causing serious problems. SUMMARY OF THE INVENTION It is the object of this invention to provide a method and arrangement for mounting a stent graft onto a deployment device and deploying the stent graft in an attempt to overcome the above problems. In one form therefore, although this may not necessarily be the only or broadest form the invention is said to reside in a stent graft prosthesis mounted to a deployment device and adapted to be deployed in a curved lumen, the curved lumen having an inner side and an outer side of the curve, the stent graft prosthesis being temporarily mounted to the deployment device at at least one end of the prosthesis by a retention arrangement, the retention arrangement of the stent graft prosthesis including a retention to the deployment device at a plurality of points of the circumference of the proximal end of the stent graft prosthesis, there being a greater circumferential distance between two adjacent retention points then other of the points, whereby when the deployment device is deployed in the curved lumen the greater circumferential distance is on the inner side of the curve. Preferably the retention arrangement includes a fastening to a release mechanism at at least two points of the circumference of the prosthesis whereby a larger and a smaller fold of the graft material is formed. More preferably three retention points may be used so that one larger and two smaller folds of the graft material are formed. In an alternative form the invention is said to reside in a deployment device and stent graft prosthesis temporarily mounted thereto and adapted to be deployed in a curved lumen, the curved lumen having an inner side and an outer side of the curve, the deployment device including a deployment catheter and a release mechanism, the stent graft prosthesis comprising a tube of graft material having a first end and a second end and being mounted to the deployment device at at least its first end by a retention arrangement, the retention arrangement including a retention to the deployment device at a plurality of points of the circumference of the proximal end of the stent graft prosthesis, there being a greater circumferential distance between two adjacent retention points then other of the points, and the retention points being provided by the release mechanism being engaged with the graft material, whereby when the deployment device is deployed in the curved lumen the greater circumferential distance is on the inner side of the curve. Preferably the retention arrangement includes a fastening to a release mechanism at at least two points of the circumference of the prosthesis whereby a larger and a smaller fold of the graft material is formed. Alternatively there may be three retention points so that one larger and two smaller folds or loops of the graft material are formed. Hence in this form the retention arrangement provides one larger fold and at least one smaller fold of the proximal end of the graft material wherein the larger fold is on the inner side of the curve when the deployment device is deployed in the curved lumen. Preferably the deployment catheter includes a guide wire catheter and a trigger wire catheter coaxially around the guide wire catheter and the release mechanism includes trigger wires passing along the annular space between the guide wire catheter and the trigger wire catheter and exiting through apertures in the trigger wire catheter. The apertures may be equally spaced around the trigger wire catheter. Preferably the trigger wires are engaged to the graft material by loops of thread-like material and the loops of thread-like material are adapted to remain with the graft material after deployment. Alternatively the trigger wires may engage directly with the graft material. Preferably the stent graft prosthesis includes stents of a self expanding type being zig zag Z stents and the tube graft material and the retention is by sutures tied to trigger wires on the deployment device and around bends of the zig zag Z stents on the stent graft prosthesis. Further retention points may be provided along the length of the stent graft prosthesis such as at the second end of the stent graft prosthesis. In an alternative form the invention is said to reside in a method of mounting of a stent graft prosthesis to a deployment device for deployment of the stent graft prosthesis in to a curved lumen having an inner side and an outer side of the curve, the method including the step of mounting the stent graft prosthesis to a deployment device so that a first end and a second end of the prosthesis are separately retained to the deployment device, the retention at the first end being by the stent graft prosthesis being retained at a plurality of points of the circumference of the stent graft prosthesis to the deployment device, there being a greater circumferential distance between the two adjacent retention points than others of the retention points and whereby in use the greater circumferential distance is placed on the inner side of the curve. Preferably the retention is by fibres such as sutures tied to trigger wires on a deployment device but other forms of retention such as by direct engagement of the trigger wires into fabric of the stent graft is also within the scope of the invention. The retention is preferably at three points around the circumference of the first end of the stent graft prosthesis. Preferably the stent graft is a type which includes stents which are zig zag Z stents covered by a graft material. Preferably the retention is by sutures tied to trigger wires on the deployment device and around bends of the zig zag Z stents on the stent graft. Preferably the deployment device comprises a guide wire catheter and a trigger wire catheter coaxially around the guide wire catheter with trigger wires passing along the annular space between the guide wire catheter and the trigger wire catheter and exiting through apertures at the retention points. The apertures may be equally spaced around the trigger wire catheter or they may be spaced at other selected spacings. Further retention points may be provided along the length of the stent graft such as at the distal end of the stent graft. In a further form the invention is said to reside in a method of deploying a stent graft prosthesis in the thoracic arch of a patient, the thoracic arch having a curvature defining an inner curve and an outer curve, the stent graft prosthesis being mounted on a deployment device under a slidable sheath and being retained to the deployment device at at least a proximal end of the stent graft prosthesis, the proximal retention being provided by retention at a number of points around the circumference of the stent graft prosthesis to provide a plurality of folds between the retention points so that one of the folds of graft material between adjacent retention points is larger than other of the folds, the method of deploying including the steps of deploying the deployment device into the aorta such that the larger of the folds of the graft material is adjacent to the inner curve, withdrawing the sheath to allow the stent graft prosthesis to expand under the influence of self expanding stents except at the proximal end so that blood flows through the larger fold at the proximal end into the interior of the stent graft prosthesis, releasing the proximal end of the stent graft prosthesis thereby allowing the graft to fully expand against the walls of the aorta and withdrawing the deployment device. It will be seen that by this arrangement blood flow through the larger fold of the proximal end of the graft will cause that side of the graft to engage against the wall of the aorta so that upon subsequent release of the entire stent graft, the stent graft will correctly engage against the walls of the aorta in the thoracic arch. In a still further form the invention is said to reside in a method of deploying a stent graft prosthesis in the thoracic arch of a patient, the thoracic arch having a curvature defining an inner curve and an outer curve, the stent graft prosthesis having a distally extending exposed stent and being mounted on a deployment device under a slidable sheath and being retained to the deployment device at a proximal end of the stent graft prosthesis and the distally extending exposed stent being retained in a capsule on the deployment device, the proximal retention being provided by retention at a number of points around the circumference of the stent graft prosthesis to provide a plurality of folds between the retention points so that one of the folds of graft material between adjacent retention points is larger than other of the folds, the method of deploying including the steps of deploying the deployment device into the aorta such that the larger of the folds of the graft material is adjacent to the inner curve, withdrawing the sheath to allow the stent graft prosthesis to expand under the influence of self expanding stents except at the proximal end so that blood flows through the larger fold at the proximal end into the interior of the stent graft prosthesis, withdrawing the capsule to release the distally extending exposed stent, releasing the proximal end of the stent graft prosthesis thereby allowing the graft to fully expand against the walls of the aorta and withdrawing the deployment device. In an alternative form the invention is said to reside in a deployment device for deploying a stent graft prosthesis into a thoracic arch of a patient, the stent graft prosthesis being temporarily mounted to the deployment device and adapted to be deployed in the thoracic arch, the thoracic arch having a curved lumen having an inner side and an outer side of the curve, the stent graft prosthesis being mounted to the deployment device at least the proximal end of the prosthesis by a retention arrangement, the retention arrangement including a retention to the deployment device at a plurality of points of the circumference of the proximal end of the stent graft prosthesis, there being a greater circumferential distance between two adjacent retention points then other of the points, whereby when the deployment device is deployed in the curved lumen the greater circumferential distance is on the inner side of the curve. In a further alternative form the invention is said to reside in an introducer for introducing a stent graft prosthesis into a curved lumen of a patient, the introducer including an arrangement for temporarily fixing the prosthesis to the introducer while it is being introduced into the lumen, wherein three or more positions on one end of the prosthesis are to be fixed to the arrangement, wherein the circumferential distance between two adjacent ones of those positions is greater than the circumferential distance between other adjacent positions of those positions and wherein the introducer serves to introduce the prosthesis into the lumen with said two adjacent positions next to the inner side of the curve of the lumen. BRIEF DESCRIPTION OF THE DRAWING This then generally describes the invention but to assist with understanding, reference will now be made to the accompanying drawings which show preferred embodiments of the invention. FIG. 1 shows a front on view of a stent graft showing where the retention points may be placed in one embodiment of the invention; FIG. 2 shows the embodiment in FIG. 1 after attachment of the retention points to trigger wires; FIG. 3 shows a schematic view of a retention arrangement for a stent graft onto a deployment device according to one embodiment of the invention; FIG. 4 shows a detailed transverse part cross section of the embodiment of FIG. 3 in the region of the proximal retention arrangement; FIG. 5 shows a longitudinal cross section of the embodiment of FIG. 3 ; FIGS. 6 to 8 show the various stages of a first embodiment of a stent graft being deployed into a thoracic arch of a patient; and FIGS. 9 to 11 show the various stages of a second embodiment of a stent graft being deployed into the thoracic arch of a patient. DETAILED DESCRIPTION U.S. Pat. No. 5,387,235 entitled “Endovascular Transluminal Prosthesis For Repair Of Aneurysms” discloses apparatus and methods of retaining grafts onto deployment devices. These features and other features disclosed in U.S. Pat. No. 5,387,235 could be used with the present invention and the disclosure of U.S. Pat. No. 5,387,235 is herewith incorporated in its entirety into this specification. U.S. Pat. No. 5,720,776 entitled “Stent Barb” discloses improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Pat. No. 5,720,776 could be used with the present invention and the disclosure of U.S. Pat. No. 5,720,776 is herewith incorporated in its entirety into this specification. U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and other features disclosed in U.S. Pat. No. 6,206,931 could be used with the present invention and the disclosure of U.S. Pat. No. 6,206,931 is herewith incorporated in its entirety into this specification. PCT Patent Publication No. WO98/53761 entitled “A Prosthesis and a Method of Deploying a Prosthesis” discloses an introducer for a prosthesis which retains the prosthesis so that each end can be moved independently. These features and other features disclosed in PCT Patent Publication No. WO98/53761 could be used with the present invention and the disclosure of PCT Patent Publication No. WO98/53761 is herewith incorporated in its entirety into this specification. PCT Patent Publication No. WO99/29262 entitled “Endoluminal Aortic Stents” discloses a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in PCT Patent Publication No. WO99/29262 could be used with the present invention and the disclosure of PCT Patent Publication No. WO99/29262 is herewith incorporated in its entirety into this specification. PCT Patent Publication No. WO03/034948 entitled “Prostheses for Curved Lumens” discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in PCT Patent Publication No. WO03/034948 could be used with the present invention and the disclosure of PCT Patent Publication No. WO03/034948 is herewith incorporated in its entirety into this specification. U.S. Provisional Patent Application No. 60/392,682 entitled “Trigger Wires” discloses release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application No. 60/392,682 could be used with the present invention and the disclosure of U.S. Provisional Patent Application No. 60/392,682 is herewith incorporated in its entirety into this specification. U.S. Provisional Patent Application No. 60/392,667 entitled “Thoracic Deployment Device” discloses introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application No. 60/392,667 could be used with the present invention and the disclosure of U.S. Provisional Patent Application No. 60/392,667 is herewith incorporated in its entirety into this specification. U.S. Provisional Patent Application No. 60/391,737 entitled “A Stent-Graft Fastening Arrangement” discloses arrangements for fastening stents onto grafts particularly for exposed stents. This feature and other features disclosed in U.S. Provisional Patent Application No. 60/391,737 could be used with the present invention and the disclosure of U.S. Provisional Patent Application No. 60/391,737 is herewith incorporated in its entirety into this specification. PCT Patent Publication No. WO03/053287 entitled “Improving Graft Adhesion” discloses arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in PCT Patent Publication No. WO03/053287 could be used with the present invention and the disclosure of PCT Patent Publication No. WO03/053287 is herewith incorporated in its entirety into this specification. U.S. Provisional Patent Application No. 60/405,769 entitled “Composite Prostheses” discloses prostheses or stent grafts suitable for endoluminal deployment. These prostheses and other features disclosed in U.S. Provisional Patent Application No. 60/405,769 could be used with the present invention and the disclosure of U.S. Provisional Patent Application No. 60/405,769 is herewith incorporated in its entirety into this specification. Now looking more closely at the drawings and in particular FIGS. 1 to 2 . Now looking more closely at the drawings and in particular FIGS. 1 to 2 . It will be seen from an end on view of the stent graft prosthesis that in its unrestrained state, as particularly shown in FIG. 1 , it has a substantially circular body end 1 . A deployment device for such a stent graft prosthesis has towards its proximal end a retention arrangement 3 for the retention of the proximal end of the stent graft body end 1 to the deployment device, the mechanism for which will be discussed in detail in relation to FIGS. 3 to 5 . The retention arrangement 3 engages various points around the circumference of the stent graft body end 1 to the deployment device to give the asymmetric arrangement as shown in FIG. 2 . To provide the stent graft retention of the present invention, points of the circumference of the graft 1 as shown by the arrows 9 in FIG. 1 are drawn towards the retention arrangement 3 and retained by thread-like material 11 such as fibres or suture material so that the end on view of the stent graft becomes substantially as shown in FIG. 2 . In this embodiment there are three retention points but other numbers of retention points may also be used. This asymmetric arrangement of stent graft attachment produces a larger fold 13 and two smaller folds 15 . It will be noted, too, that the larger circumferential portion of the proximal end of the graft produces the larger fold 13 and the smaller circumferential portions of the proximal end of the graft produce the smaller folds 15 . One embodiment of a deployment device and stent graft suitable for the stent graft retention of the present invention is shown in FIGS. 3 to 5 . The deployment device 2 in the region of the proximal retention has a guide wire catheter 4 and a trigger wire catheter 8 coaxially around the guide wire catheter 4 . Trigger wires 5 pass along the annular space 10 between the guide wire catheter 4 and the trigger wire catheter 8 and exit through apertures 7 at the retention points and then re-enter the annular space 10 between the guide wire catheter 4 and the trigger wire catheter 8 and pass into the nose cone 6 . The apertures 7 may be equally spaced around the trigger wire catheter or they may be spaced at other selected spacings. In this embodiment there are three apertures 7 spaced at approximately 120 degrees to each other around the circumference of the trigger wire catheter 8 . Where each trigger wire 5 exits out of aperture 7 a thread of suture material or other thread-like material 11 is looped around the trigger wire 5 and is fastened to a bight 14 of the graft material of the stent graft 1 and tied off with a knot 12 . As can particularly be seen in FIG. 3 the stent graft has zig zag Z stents 17 on its inside for the first two stents from the proximal end and then outside zig zag Z stents 19 distally thereof. Each stent is fastened by of sutures 21 to the graft material. Barbs 23 may also be used to encourage retention of the stent grafts against the wall of the aorta. It will be noted that the barbs 23 are distally facing so that pressure of blood flow will cause then to engage more strongly into the wall of the aorta. In some embodiments the thread of suture material or other thread-like material 11 may also be fastened around a portion of the zig zag Z stent 17 . Now looking at the embodiment shown in FIGS. 6 , 7 and 8 it will be seen that a thoracic arch 30 of an aorta 25 has an outer curve 33 and an inner curve 31 . A stent graft is deployed into the thoracic arch to span, for instance, a tear 26 in the wall of the aorta 25 which has caused an aortic dissection 27 . A deployment device 32 is inserted into the aorta 25 and bent around the thoracic arch 30 . Owing to the curvature of the thoracic arch 30 the deployment device 32 will tend to be nearer the outer curve 33 and hence to ensure good engagement of the stent graft on the inner curve, the stent graft retention of the present invention is used. As can be seen in FIG. 6 the deployment device 32 which is deployed into the thoracic arch 30 has a stent graft prosthesis 34 as shown by the dotted line held within a movable outer sheath 36 . In this embodiment the prosthesis 34 does not have a distal retention mechanism associated with the deployment device and hence when the sheath 36 is withdrawn as shown in FIG. 7 the stent graft under the influence of its self expanding stents 35 opens except at the proximal end 38 where the graft is retained to the deployment device 32 by means of the stent graft retention of the present invention. As can be particularly be seen in FIG. 7 the larger fold 13 of the stent graft is extended towards the inner side of the curve 31 of the thoracic arch 30 and in this position blood flow can flow through the larger fold 13 and cause it to extend against the inner wall 31 before the stent graft fully engages the outer side of the curve 33 . At this stage barbs 23 , (see FIG. 3 ) if present, at the proximal end can engage into the inner wall 31 of the aorta and ensure that that portion of the proximal end of the stent graft is retained against the inside wall of the aorta 25 . As shown in FIG. 8 trigger wires have been released (by a mechanism not shown) so that the stent graft retention has been released and the full circumference of the proximal end of the graft has now fully deployed against the walls of the thoracic arch. Hence there is not the danger of a portion of the circumference of the proximal end of the graft, particularly that engaged against the inner curve 31 folding inwards under the influence of pulsating blood flow and closing off the aorta. Other barbs 23 , if present at the proximal end, can then engage the wall of the aorta and ensure that that the entire proximal end of the stent graft is retained against the wall of the aorta. It will be noted that in this embodiment the fastenings 11 , which are used to retain the stent graft to the trigger wires, remain on the stent graft. An alternative embodiment of deployment of a stent graft prosthesis retained by the arrangement of the present invention is shown in FIGS. 9 , 10 and 11 . The stent graft in this embodiment is used to span an aneurysmal sac 29 . A number of features are substantially similar to those of FIGS. 6 , 7 and 8 and the same reference numerals are used for corresponding items. The stent graft prosthesis is similar at the proximal end to that depicted in FIGS. 6 to 8 , but at its distal end it has a distally extending exposed zig zag Z stent 42 . This distally extending exposed stent 42 may have barbs 47 . In this embodiment the deployment device is deployed in the aorta 30 in the same manner as shown in FIG. 6 but subsequent deployment of the stent graft prosthesis occurs in two stages. In a first stage the sheath 36 is withdrawn, as was shown FIG. 7 , but as well as the proximal end 38 being retained by the asymmetric proximal stent graft attachment a capsule 40 retains the exposed stent 42 at the distal end. In the next stage as shown in FIG. 10 , the capsule is withdrawn distally so that the exposed stent is released and because of their self expanding nature expand to bear against the walls of the aorta at the distal end of the stent graft prosthesis. The barbs 47 can engage into the wall of the aorta to retain the stent graft in position. At this stage the proximal end 38 of the stent graft prosthesis is still retained to the deployment device by the retention arrangement of the present invention. It will be noted that the larger fold 13 of the graft is towards the inner side of the curve 31 of the thoracic arch 30 and in this position blood flow can flow through the larger fold 13 and cause it to extend against the inner wall 31 before the graft fully engages the outer side of the curve 33 . Then as shown in FIG. 11 , in a similar manner to that shown in FIG. 8 , the trigger wires can be released (by a mechanism not shown) so that the stent graft prosthesis is released and the full circumference of the proximal end of the graft can fully deploy against the walls of the thoracic arch. Hence there is not the danger of a portion of the circumference of the proximal end of the graft, particularly that engaged against the inner curve 31 folding inwards and closing off the aorta. Other barbs 23 , if present at the proximal end, can then engage the wall of the aorta and ensure that that the entire proximal end of the stent graft is retained against the wall of the aorta. It will be noted that in this embodiment the fastenings 11 , which are used to retain the stent graft to the trigger wires, remain on the stent graft. The nose cone 44 of the deployment device can then be withdrawn to the capsule 40 and the deployment device withdrawn. Throughout this specification various indications have been given as to the scope of the invention but the invention is not limited to only one of these but may reside in two or more of these combined together. The examples are given for illustration only and not for limitation.

1a

BACKGROUND [0001] Arthroscopic surgery is a minimally invasive surgical procedure in which an examination and sometimes treatment of damage of the interior of a joint is performed using an arthroscope, a type of endoscope that is inserted into the joint through a small incision. Arthroscopic procedures, such as repairing a torn rotor cuff, often require soft tissue to be reattached to bone. To achieve this, anchors (sometimes called “suture anchors”) are placed in the bone and sutures attached to the anchor are passed through the tissue to securely retain the tissue in place. SUMMARY [0002] To reduce the amount of bone stock removed by an anchor and minimize invasiveness, ever smaller open architecture anchors are being used. However, smaller open architecture anchors result in a problematic tradeoff between reduced interior volume of the anchor and weakened drive support structure. In order to maintain structural integrity during screw-in insertion, drive elements must be capable of withstanding the torsion required for insertion of the anchor. Drive ribs are typically provided within an internal volume of an anchor to provide a structural element for a driver to apply torsion during insertion. However, as the size of the anchor is reduced, drive ribs of adequate depth/size to drive an anchor begin to occlude internal suture passages. A need therefore exists for a drive support structure to be capable of withstanding torsional drive forces during anchor insertion and to have a sufficiently small profile to avoid occlusion of internal suture passages. [0003] The foregoing needs are addressed by an open architecture anchor having a dual drive system using both drive ribs and an internal polygonal (e.g., hexagon, octagon, square, or any other regular or irregular polygon) drive feature. This new dual drive feature allows the anchor to withstand torsional drive forces while including drive ribs of a reduced size. The internal volume of the anchor thereby is maintained such that adequate cross-sectional area is provided for the passage of sutures through the anchor and/or driver. Using a smaller anchor allows for preservation of bone stock and more rapid healing. [0004] Accordingly, in one aspect, at least one embodiment described herein relates to an anchor for securing soft tissue to bone, for example, to repair a torn rotator cuff. The anchor includes at least one open helical coil defining a polygonal internal volume communicating with a region exterior to the at least one open helical coil through a spacing between turns of the at least one open helical coil, wherein the polygonal internal volume is sized to engage a driver. The anchor also includes at least one rib disposed within the polygonal internal volume and connected to at least two turns of the at least one open helical coil, wherein the at least one rib is sized to engage the driver and a combination of the at least one rib and the polygonal internal volume is sized to provide an anchor drive torque required to drive the anchor into bone. [0005] Any of the embodiments described herein can include one or more of the following embodiments. In some embodiments the polygonal internal volume further comprises a cross-sectional shape including at least one of a regular polygon; irregular polygon; square, rectangle, triangle, hexagon, and/or octagon. In some embodiments, the at least one rib includes a first rib positioned on a first side of the polygonal internal volume and a second rib positioned on a second side of the polygonal internal volume. In some embodiments, the anchor also includes a suture bridge affixed to and disposed within a distal end of the anchor. In some embodiments, the at least one open helical coil is a dual lead helical coil. [0006] In another aspect, at least one embodiment described herein provides a tissue repair system. The system includes a driver comprising a handle and a polygonal shaft connected to the handle, at least part of the polygonal shaft having a polygonal-shaped cross-section, the polygonal shaft including a distal end having at least one groove extending toward a proximal end of the polygonal shaft. The system also includes an anchor engageable with a distal end of the driver. The anchor includes at least one open helical coil defining a polygonal internal volume communicating with a region exterior to the at least one open helical coil through a spacing between turns of the at least one open helical coil, wherein the polygonal internal volume is sized to engage the polygonal shaft of the driver. The anchor also includes at least one rib disposed within the polygonal internal volume and connected to at least two turns of the at least one open helical coil, wherein the at least one rib is sized to engage the at least one groove of the driver and a combination of the at least one rib and the polygonal internal volume is sized to provide an anchor drive torque required for the driver to drive the anchor into bone. [0007] The anchors and systems for tissue repair described herein (hereinafter “technology”) can provide one or more of the following advantages. One advantage of the technology is that a smaller open architecture anchor can be provided by including a polygonal internal volume and reduced profile drive ribs. The combination of the polygonal internal volume and reduced profile drive ribs can advantageously distribute a torsional drive force, thereby maintaining structural integrity during insertion of the anchor into bone despite the reduced size and load capability of the reduced profile drive ribs. The reduced profile drive ribs advantageously allow for smaller open architecture anchors to maintain sufficiently large internal suture passages to pass one or more sutures. The open architecture of the technology advantageously allows for bony ingrowth, thereby reducing patient recovery time. The reduced size of the open architecture advantageously preserves bone stock, thereby preserving bone integrity and reducing patient recovery time. The reduced size of the open architecture also advantageously allows a higher percentage of the diameter of the anchor to be dedicated to thread depth, thereby improving fixation strength of the anchor in the bone. [0008] Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that 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 THE DRAWINGS [0009] The foregoing and other objects, features, and advantages will be apparent from the following more particular description of the embodiments as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles, characteristics, and features of the embodiments. In the drawings: [0010] FIG. 1A is an end view of a proximal end of an example open architecture anchor in accordance with various embodiments. [0011] FIG. 1B is an isometric view of the example open architecture anchor of FIG. 1 in accordance with various embodiments. [0012] FIG. 1C is second isometric view of the example open architecture anchor of FIG. 1 in accordance with various embodiments. [0013] FIGS. 2A and 2B are cross-sectional views of a polygonal internal volume of alternative open architecture anchors in accordance with various embodiments, wherein the ribs have been omitted for clarity. [0014] FIG. 3A is an isometric view of an example anchor driver in accordance with various embodiments. [0015] FIGS. 3B and 3C are a cross-sectional views of alternative distal ends of the example anchor driver of FIG. 3A in accordance with various embodiments. [0016] FIG. 4 is an isometric view of an example tissue fixation system in accordance with various embodiments. DETAILED DESCRIPTION [0017] The following description of examples is in no way intended to limit the disclosure, its application, or uses. [0018] FIGS. 1A-1C show an example of an anchor 100 including at least one (open) helical screw thread 105 . The helical screw thread 105 defines a polygonal internal volume 110 (e.g., hexagonal as shown). The polygonal internal volume 110 communicates with a region exterior to the at least one open helical coil screw 105 through a spacing 115 between turns of the helical screw thread 105 . The polygonal internal volume 110 engages a corresponding polygonal shaft of an anchor driver (e.g., polygonal shaft 301 of anchor driver 300 as shown in FIGS. 3A-3B ). [0019] In use, the anchor 100 is located at a distal end of the anchor driver such that the polygonal shaft engages the polygonal internal volume of the anchor 100 . A torsional drive force is then applied to the anchor 100 by the anchor driver to insert the anchor 100 into bone. In various embodiments, the anchor driver can engage the polygonal internal volume 110 along only a portion of the longitudinal length of the anchor (i.e., from proximal end 130 a to distal end 130 b ). Engagement of substantially the entire length of the polygonal internal volume 110 by the anchor driver, in accordance with various embodiments, can be advantageous because the torsional drive force applied to the anchor 100 during insertion can be distributed throughout the length of the anchor 100 , rather than concentrated on a smaller portion of the anchor 100 . After the anchor 100 is inserted into bone and the patient begins to heal, new bone grows into the internal volume 110 through the spacing 115 . For faster and more complete healing, this “bony ingrowth” is highly desirable. [0020] In another embodiment, the anchor 100 further includes at least one rib 120 (e.g., two as shown) connected to at least two turns of the helical screw thread 105 . The ribs 120 engage corresponding grooves of an anchor driver (e.g., grooves 305 of anchor driver 300 as shown in FIGS. 3A-3B ). In use, the anchor 100 is located at a distal end of the anchor driver such that the grooves engage the ribs 120 of the anchor 100 . In various embodiments, a surgeon inserts the anchor 100 into bone using the anchor driver by applying a torsional drive force to the driver, which transmits the torsion to the anchor 100 , thereby screwing the anchor into bone. [0021] In various embodiments, engagement of the anchor driver with both the polygonal internal volume 110 and the ribs 120 of the anchor 100 advantageously distributes the torsional drive force between the ribs 120 and the polygonal internal volume 110 . Such load distribution, in various embodiments, will allow the anchor 100 to withstand the torsional drive force despite having undersized drive ribs 120 . For example, ribs 120 having a width (w) and/or height (h) too small to independently support the torsional drive force can be used in combination with a polygonal internal volume 110 to establish the necessary structural properties of the anchor 100 . In various embodiments, the anchor driver can engage the polygonal internal volume 110 and/or the ribs 120 along only a portion of the longitudinal length of the anchor (i.e., from proximal end 130 a to distal end 130 b ). However, engagement of substantially the entire length of the polygonal internal volume 110 and/or the ribs 120 by the anchor driver, in accordance with various embodiments, can be advantageous because the torsional drive force applied to the anchor 100 during insertion can be distributed throughout the length of the anchor 100 , rather than concentrated on a smaller portion of the anchor 100 . This further distribution allows further reduction in width (w) and/or height (h). The reduced width (w) and/or height (h) can, in various embodiments; advantageously prevent occlusion of a cross-sectional area of the polygonal internal volume 110 such that sutures can pass inside the anchor 100 and/or the anchor driver. [0022] The anchor 100 , in various embodiments, can also include a suture bridge 140 attached to and disposed at least partially within a distal end 130 b of the anchor 100 . The suture bridge 140 can be located entirely within the distal end 130 b of the anchor 100 (e.g., as shown in FIG. 1B ) but can also protrude distally from the distal end 130 b . The suture bridge 140 can, in various embodiments, include a rounded distal-facing region around which one or more sutures can be routed. In such embodiments, a first end of each suture extends proximally through the anchor 100 on a first side of the suture bridge 140 a and a second end of each suture extends proximally through the anchor 100 on a second side of the suture bridge 140 b . The suture bridge 140 advantageously retains one or more sutures within the anchor 100 while preventing the cutting, pinching, and/or other weakening of the sutures associated with positioning the sutures between the anchor 100 and the bone. [0023] Some examples of the anchor 100 include two helical screw threads 105 in a “dual lead” thread arrangement. Dual lead means that two “ridges” are wrapped around the anchor 100 . The anchor 100 can be constructed from, for example but not limited to, polymers (e.g., polyetheretherketone), bioabsorbable materials, metals (e.g., surgical steel, titanium), or any other suitable material. [0024] As shown in FIGS. 1A , 2 A, and 2 B, any regular polygonal or irregular polygonal shape can be used for the polygonal internal volume 110 , 210 , 260 of the anchor 100 , 200 , 250 , respectively, in accordance with various embodiments. Shapes of the polygonal internal volume 110 , 210 , 260 can include, for example but are not limited to, a hexagon (e.g., the shape of internal volume 110 as shown in FIG. 1A ), a rectangle (e.g., the shape of internal volume 210 as shown in FIG. 2A ), an octagon (e.g., the shape of internal volume 260 as shown in FIG. 2B ), a triangle, a star-shape, a trapezoid, and/or any other suitable non-circular shape capable of engaging with a driver to receive at least a portion of a transmitted torsional drive force. [0025] FIGS. 3A-3C show an anchor driver 300 in accordance with various embodiments. The anchor driver includes a polygonal shaft 301 connected at a proximal end to a handle 303 . The polygonal shaft 301 includes one or more grooves 305 (e.g., two as shown) extending toward a proximal end of the polygonal shaft 301 . The polygonal shaft 301 , in various embodiments, can have a polygonal-shaped cross-section along its entire longitudinal length. In various embodiments, the polygonal shaft 301 can have a polygonal-shaped cross section along only a portion of its longitudinal length and can have at least one different cross-sectional shape (e.g., a different polygon, a circle, an ellipse) along one or more additional portions of its longitudinal length. [0026] As shown in FIG. 3B , the one or more grooves 305 can be provided, in various embodiments, as cut-out grooves 305 a which are open to an interior of the polygonal shaft 301 . As shown in FIG. 3C , the one or more grooves 305 can be provided, in various embodiments, as channel grooves 305 b . As described above, in various embodiments, the polygonal shaft 301 can be inserted into the polygonal internal volume (e.g., 110 as described above) of an anchor (e.g., 100 as described above) to engage the polygonal shaft 301 with the polygonal internal volume and the grooves 305 with the ribs (e.g., 120 as described above). [0027] In various embodiments, the handle 303 can be manufactured from a polymer material and via an injection molding process. However, any other suitable material (e.g., metals, composites, wood) and/or process (e.g., extrusion, machining, electro-chemical machining) can be used. The polygonal shaft 301 and/or any surfaces defining a groove 305 thereon can be made from a metal material via an extrusion or drawing process. However, any other suitable material (e.g., plastics, composites) and/or process (e.g., injection molding, casting, machining, electro-chemical machining) can be used. The polygonal shaft 301 can be coupled to the handle 303 via an interference fit. However, any other suitable method of coupling (e.g., screws, adhesives, rivets) can be used. [0028] FIG. 4 illustrates a tissue fixation system 400 in accordance with various embodiments. The tissue fixation system 400 includes an anchor 410 engaged with a driver 430 . In various embodiments, one or more sutures (not shown) can be installed such that each suture passes around a suture bridge (e.g., 140 as shown in FIG. 1 ) and the ends of each suture extend toward a proximal end of the tissue fixation system 400 through the anchor 410 , a grooved polygonal shaft 401 of the anchor driver 430 , and/or a handle 403 of the anchor driver 430 . In various embodiments, a surgeon can apply a torsional drive force to the handle 403 , which transmits the torsional drive force to the grooved polygonal shaft 401 thereby applying the torsional drive force to the anchor 410 to screw the anchor 410 into bone. In various embodiments, the anchor 410 may include, for example but not limited to, any anchor 100 , 200 , 250 as described hereinabove with reference to FIGS. 1A-1C and FIGS. 2A-2B . In various embodiments, the anchor driver 430 , the handle 403 , and/or the grooved polygonal shaft 401 may include, for example but not limited to, any anchor driver 300 , any polygonal shaft 301 , any grooves 305 , 305 a , 305 b , and/or any handle 303 as described hereinabove with reference to FIGS. 3A-3C . [0029] As various modifications could be made in the constructions and methods herein described and illustrated without departing from the scope of the invention, it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by any of the above-described examples, but should be defined only in accordance with the following claims appended hereto and their equivalents.

1a

This is a Continuation-In-Part application of application Ser. No. 09/058,087 filed Apr. 9, 1998, U.S. Pat. No. 5,954,357. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to a winter sport apparatus. More particularly, the invention concerns a novel winter sport apparatus for gliding over snow which includes unique snow boots which are removably connected to a snow engaging support base such as a snow-board or ski board through the use of magnets. 2. Discussion of the Prior Art In recent years snow sports have continually increased in popularity. While, for many years snow skiing was the sport of choice among winter sport enthusiasts, recently, the sport of snow-boarding has catapulted into popularity particularly among young persons. With the increase in popularity of snow boarding has come the demand for better and easier-to-use equipment. Particularly in demand is the need for superior boots and bindings. As a general rule, the boots and bindings used for snow boarding are the same as used for snow skiing and closely resemble those which have been used for over fifty years. Typically, the bindings comprise rather heavy, bulky frames which are affixed to the upper surface of the snow-board with the boots being affixed to the frames by conventional types of straps, buckles and wires of the character used in snow skiing. These type of bindings are generally cumbersome, difficult to use and often fail to provide a type of interconnection between the boots and the snow-board which is essential to the sport of snow boarding. Among the more recent improvements in snow sport bindings are those described in U.S. Pat. No. 5,558,355 issued to Henry. The Henry patent describes a binding which is particularly suitable for snow boarding and provides an easy-to-use, kick-in boot engagement feature and a number of convenient ways to disengage the boot in a relative small, light-weight, and economical structure. Another type of ski binding is disclosed in U.S. Pat. No. 5,143,397 issued to Stepanek et al. This patent describes a part for a ski binding comprising a carriage slidably attached to a base plate. One end of the base plate is fastened to the ski with fasteners while the other end rests freely on the bottom of a U-shaped clamp also fastened to the ski with fasteners. Attachment of the carriage to the base is accomplished by carriage structural features that retain the carriage in the clamp and further carriage structural features that prevent the carriage from being vertically disengaged from the part of the base adjacent to the base plate fastened end. Still another improved binding for a snow-board is that described in U.S. Pat. No. 5,143,369 issued to Shaanan et al. The Shaanan et al patent concerns a binding for a snow-board that has a base, side members extending upwardly and rearwardly from the sides of the base with an arcuate member joining the rear ends of the side members. Fastening means on one of the side members and one side edge of the board at the front provide for attachment of one end of two straps. Fastening means on the other side member and on the other side edge serve for attachment of a locking bar which, in turn, connects the other end of each strap to the side member and base. The foregoing prior art patents represent some of the more recent attempts to improve the quality of snow boots and bindings particularly for use in connection with snow boarding. While the devices disclosed in the aforementioned patents constitute substantial improvements over the prior art, they nevertheless remain somewhat complicated, bulky and difficult to use. The thrust of the present invention is to overcome the drawbacks of the prior art snow-ski and snow-board boots and bindings and to provide a universal boot and binding which is easy to use and enables the quick and positive interconnection of the snow boots with the upper surface of the ski or snow-board. SUMMARY OF THE INVENTION It is an object of the present invention to provide a universal snow boot and binding for use in connection with either snow skiing or snow boarding which is easy to use and provides quick, easy and positive interconnection of the snow boot with the upper surface of the ski or snow-board. More particularly, it is an object of the invention to provide a highly novel snow boot and binding in which only magnetic forces are used to affix the snow boot to the ski or snow-board. Another object of the invention is to provide an apparatus of the character described in the preceding paragraphs which is light-weight, is simple to manufacture and install, and is virtually fail-safe in operation. Another object of the invention is to provide an apparatus of the afore-mentioned character which includes novel means for quickly and easily disconnecting the snow boot from the upper surface of the snow-board or snow ski which carries the magnetic elements of the apparatus. Another object of the invention is to provide an apparatus as described in the preceding paragraph in which the release mechanism comprises an easy-to-use, hand-operated lever which enables the skier or the snow-boarder to quickly and easily disconnect the snow boot from the upper surface of the ski or snow-board. Another object of the invention is to provide cooperating gripping means on the snow boot and the magnet to prevent accidental slippage of the snow boot relative to the magnet. Another object of the invention is to provide a novel ski boot and cooperating binding which is compact, lightweight and of a simple, straight forward construction that and can be inexpensively manufactured. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side-elevational view of the support base portion of one form of the apparatus of the invention for gliding over snow. FIG. 2 is a top plan view of the support base shown in FIG. 1 . FIG. 3 is an enlarged, cross-sectional view taken along lines 3 — 3 of FIG. 2 . FIG. 4 is an enlarged, cross-sectional view taken along lines 4 — 4 of FIG. 3 FIG. 5 is a side-elevational view of one form of the foot enclosure assembly of the apparatus of the invention. FIG. 6 is a view taken along lines 6 — 6 of FIG. 5 . FIG. 7 is a greatly enlarged, cross-sectional view taken along lines 7 — 7 of FIG. 5 . FIG. 8 us a top plan view similar to FIG. 2 but showing the foot enclosure assembly of the invention in position on the support base of the apparatus. FIG. 9 is an enlarged view taken along lines 9 — 9 of FIG. 8 . FIG. 10 is a view taken along lines 10 — 10 of FIG. 9 . FIG. 11 is a cross-sectional view taken along lines 11 — 11 of FIG. 10 . FIG. 12 is a side-elevational view similar to FIG. 5, but illustrating the manner of operation of one form of the operating means of the invention for disengaging the foot enclosure assembly from the magnet affixed to the support base. FIG. 13 is a view taken along lines 13 — 13 of FIG. 12 . FIG. 14 is an enlarged, cross-sectional view taken along lines 14 — 14 of FIG. 13 . FIG. 15 is a generally perspective view of the upper portion of the release means of the apparatus of the invention for separating the foot enclosure from the support base. FIG. 16 is a side-elevational view of the apparatus of the invention for gliding over snow. In this form of the invention, the support base as shown in the form of a conventional ski rather than a snow-board. FIG. 17 is a top plan view of the support base portion of the apparatus shown in FIG. 16 . FIG. 18 is a greatly enlarged, cross-sectional view taken along lines 18 — 18 of FIG. 17 . FIG. 19 is a side-elevational, exploded view, partly in cross-section showing an alternate embodiment of the invention. FIG. 20 is a foreshortened view taken along lines 20 — 20 of FIG. 19 . FIG. 21 is a foreshortened view taken along lines 21 — 21 of FIG. 19 . FIG. 22 is a side-elevational view similar to FIG. 19 but showing the foot enclosure assembly in engagement with the specially configured magnet. FIG. 23 is an enlarged, fragmentary view of the area designated in FIG. 22 by the numeral 23 . FIG. 24 is a side-elevational view of yet another form of the apparatus of the invention. FIG. 25 is a view taken along lines 25 — 25 of FIG. 24 . FIG. 26 is a view taken along lines 26 — 26 of FIG. 24 partly broken away to show internal construction. FIG. 27 is a cross-sectional view taken along lines 27 — 27 of FIG. 26 . FIG. 28 is a generally perspective view of a portion of one form of the release means of this latest form of the invention. FIG. 29 is a cross-sectional view taken along lines 29 — 29 of FIG. 26 FIG. 30 is a cross-sectional view taken along lines 30 — 30 of FIG. 26 FIG. 31 is a plan view similar to FIG. 26 but showing the release means moved into a foot enclosure release configuration. FIG. 32 is a cross-sectional view similar to FIG. 27 but showing the foot enclosure separated from the support base. FIG. 33 is a plan view of an alternate form of release means of the invention. DESCRIPTION OF THE INVENTION Referring to the drawings and particularly to FIGS. 1 through 7, one form of the apparatus of the invention for gliding over snow is there shown. In this form of the invention, there are three principal cooperating components, namely, a support base 14 , a foot enclosure assembly 16 , and release means connected to the foot enclosure assembly for releasably interconnecting the foot enclosure assembly with the support base. Support base 14 includes an upper surface 14 a and a lower surface 14 b and, in the form of the invention shown in FIGS. 1 and 2, comprises a snow-board. As best seen in FIGS. 3 and 4, the upper surface 14 a of support base 14 is provided with a pair of spaced-apart, generally circular shaped recesses 17 within which is mounted a generally circular shaped magnet 18 . Magnets 18 are of a high holding power, compact design, and can be constructed from various materials. By way of example, magnets 18 can comprise powerful ceramic ring, permanent magnets which are readily commercially available from various sources including A-L-L Magnetics, Inc. of Palencia, Calif. These ceramic magnets can be constructed in various configurations and, if desired, can be encased in nickel-plated steel cups. Magnets 18 are commercially available in a number of different sizes and range in diameter from about 2 inches to about 5 inches. The larger of these magnets exhibit holding power of on the order of 200 pounds per magnet. It is to be understood that in constructing the apparatus of the present invention, a single relatively large magnet can be used, or in the alternative, a plurality of smaller magnets disposed in a suitable array can be used to provide the magnetic forces necessary to releasably secure the foot enclosure assembly of the apparatus to the support base. By way of example a snow-board of a nominal length will require one magnet per foot enclosure with a pulling strength of about 150 pounds per magnet. This will achieve a total pulling strength of 300 pounds. The average weight of a person using a snow-board will typically be about 150 pounds. The magnets will then have double the pulling strength of the weight to be held in the desired position on the snow-board. Referring to FIG. 5, the foot enclosure assembly 16 of the present invention can be seen to comprise a snow boot-like foot enclosure 20 and a first metal plate 22 which is affixed to the lower surface of the snow boot 20 by any suitable means such as rivets 23 (FIGS. 6 and 7 ). Plate 22 may be constructed from any suitable rigid metal which is capable of being attracted by the magnets 18 which are interconnected with the support base 14 by adhesive bonding or any other suitable means. Also forming a part of the foot enclosure assembly of the invention is a second plate 24 which is pivotally connected to plate 22 for very limited movement of a few degrees about a pivot pin 26 . More particularly, as shown in FIG. 5, plate 24 extends upwardly from plate 22 and normally is disposed generally perpendicularly with respect thereto. Plate 24 functions to provide support to the heel portion of the foot enclosure 20 , but permits slight forward movement through a limited distance of X (FIG. 5 ). However, plate 24 positively resists rearward angular movement of the rear portion of the boot and lower leg of the user. The distance X can, of course, vary depending upon the physical stature of the user, but generally is on the order of about 1 inch. This movement is sufficient to permit the skier or snow boarder to comfortably lean forward in the binding but, at the same time, provides support against rearward angular leaning movement relative to plane of the support base. Forming an important feature of the apparatus of the present invention is the release means for releasing the foot enclosure assembly from the support base. As best seen by referring to FIGS. 14 and 15, the release means here comprises a guide frame 27 which includes a rear plate 28 that is securely affixed to plate 24 of the foot enclosure assembly. Protruding rearwardly from plate 28 are a pair of transversely spaced-apart side members 30 and a top closure plate 32 . Spaced-apart sides 30 , along with a back wall or rear plate 38 , cooperate to define a guideway 34 (FIG. 14) within which a release plate 36 is telescopically movable from the first upper position shown in FIG. 11 to the second, release position shown in FIG. 14 . Rear plate 38 is provided with a vertically extending, elongated guide slot 40 (FIG. 13 ), which guides the vertical travel of a guide pin 42 which is affixed to release plate 36 . With this construction, as release plate 36 moves from the first position shown in FIG. 11 to the release position shown in FIG. 14, guide pin 42 moves from a position proximate the upper extremity of guide slot 42 (FIG. 11) to a second position proximate the lower extremity of the guide slot 40 (FIG. 14 ). In the embodiment of the invention shown in the drawings, release plate 36 is controllably moved from the uppermost position shown in FIG. 11 to the release position shown in FIG. 14 by operating means which here comprises as a cam assembly 48 . Cam assembly 48 includes a cam member 50 having outwardly extending bosses 52 which are affixed at either side of the cam member in the manner shown in FIG. 15 . As shown in FIG. 13, bosses 52 extend through aligned openings 54 provided in side walls 30 of FIG. 26 . With this constrtuction, a handle assembly 56 can be used to pivot cam member 50 from the position shown in FIG. 11 to the release position shown in FIG. 14 . Handle assembly 56 of the character best seen in FIG. 15 . As there shown, handle assembly 56 includes two spaced-apart side arms 58 , each of which terminates at its upper end in a generally annular shaped connector 58 a which is connected to bosses 52 of cam member 50 by suitable connectors such as a set screw 59 (FIG. 15 ). The opposite, or out board end 58 b of each of the arm 58 is connected to a two-part handle member 60 comprising portions 60 a and 60 b . When portions 60 a and 60 b are interconnected in the manner shown in FIG. 10 the handle member can be grasped by the user in a manner to move the handle assembly from the position shown in FIG. 11 to the upward release position shown in FIG. 14 . As shown in FIGS. 11 and 14, as the handle assembly is pivoted upwardly, release plate 36 will be forced downwardly by cam member 50 causing the lower extremity 36 a thereof to move into pressural engagement with the upper surface 14 a of the support base. As the handle assembly is urged upwardly in the manner shown in FIGS. 12 and 14, release plate 36 will be urged downwardly so that plate 22 will be separated from the magnet 18 thereby breaking the magnetic attraction and allowing separation of the foot enclosure assembly from the support base. Following separation of the foot enclosure assembly from the base plate, the handle assembly is, of course, pivoted downwardly into the starting position so that the foot enclosure assembly can, at such time as is desired, be reconnected to the base plate by superimposing plate 22 over a selected one of the magnets 18 . Turning next to FIGS. 16 through 18, an alternate form of the apparatus of the present invention for gliding over snow is there shown. This apparatus is similar in many respects to the apparatus shown in FIGS. 1 through 15. However, in this latest form of the invention the support base, rather than being a snow-board, comprises a ski 63 of a generally conventional configuration. Ski 63 has an upper surface 63 a , and a lower snow engaging surface 64 b . Upper surface 63 a is provided with a generally rectangular shaped cavity 65 within which is affixed permanent magnet 67 . Magnet 67 is of the same character as the magnets 18 previously discussed herein and is preferably constructed from a powerful magnetizable ceramic or metal material . Once again, magnet 67 should be designed to apply a force of approximately 150 pounds on the metal plate of the foot enclosure assembly which is identical to that previously described. Because the foot enclosure assembly, as well as the release means of this second apparatus of the apparatus is identical to that described in connection with FIGS. 1 through 15, like numerals are used in FIG. 16 to identify like components of the foot enclosure assembly and release means. It is to be understood that when two skis are used, each ski is of the general construction shown in FIGS. 16 and 17 with each ski being provided with a magnet receiving cavity 65 and an appropriately powerful permanent magnet 67 embedded therewithin. Use of the release means of the invention to release the foot enclosure assembly from the ski is accomplished in the same manner as previously described herein. Turning to FIGS. 19 through 23, still another alternate form of the apparatus of the invention is there shown. This apparatus is similar in many respects to that illustrated in FIGS. 1 through 18 and like numerals are used in FIGS. 19 through 23 to identify like components. The major difference between the apparatus of the invention shown in FIGS. 19 through 23 and the earlier-described embodiments of the invention resides in the provision of anti-slip gripping means on the first metal base plates of the foot enclosure assemblies and on the magnets which are affixed to the support base of the apparatus. As best seen by referring to FIGS. 19 and 20, the g&ripping means provided on the metal base plates of each of the foot enclosure assemblies of the invention here comprises a multiplicity of downwardly extending, generally conically shaped, spike-like protuberances 70 . Protuberances 70 extend downwardly from the central portion of metal base plate 72 of the foot enclosure assemblies of this latest form of the invention and as indicated in FIG. 23, are generally conical in shape. Also forming a part of the gripping means of this latest form of the apparatus of the invention are a multiplicity of generally conically-shaped cavities 74 which are formed in magnet 76 of this latest form of the invention. Depressions, or cavities 74 , are of the same general size and configuration as conically shaped protuberances 70 so that when the foot enclosure assemblies are mated with the magnets, protuberances 70 will be received within cavities 74 so as to prevent slippage between metal plate 72 of the foot enclosure assemblies and magnets 76 which are affixed to support base 14 . As best seen in FIG. 21 in this latest form of the invention, magnets 76 are generally rectangular in shape and are suitably secured within rectangularly shaped cavities 78 formed in the support bases. It is to be understood that protuberances 70 can be of a number of different shapes. For example, the protuberances can comprise spaced-apart downwardly extending ribs which can be received within mating grooves provided in the magnets or, alternatively, they could be generally hub-like in shape and be received within socket-like cavities provided in the magnets. In any case, so long as the protuberances when received in mating cavities formed in the magnet function to prevent slippage between the foot enclosure assemblies and the magnets, their precise configuration is unimportant. In a similar fashion, the gripping means of the invention could comprise cooperating side frames provided on the foot enclosure assemblies and the magnet or support base to resist sliding movement of the foot enclosure assemblies relative to the support base. Referring next to FIGS. 24 through 32, yet another form of the apparatus of the invention for gliding over snow is there shown and generally designated by the numeral 82 . This form of the invention is similar in some respects to the earlier described embodiments and like numbers are used to identify like components. In this latest embodiment of the invention there are four principal cooperating components, namely, a support base 84 , a foot enclosure means for enclosing the ulser's foot, connector means for releasably connecting the foot enclosure means to the connector means and release means for releasing the foot enclosure means from the connector means. As best seen in FIGS. 24, 26 and 27 , the connector means of the invention includes a connector frame 86 that is provided with a pair of spaced-apart, generally oval shaped recesses 87 within which generally circular shaped second magnets 88 are slidably mounted. As before, magnets 88 are of a high holding power, compact design, and can be constructed from various materials of the character previously described herein. Connector frame 86 is connected to the upper surface 84 a of the support base which surface is spaced apart from the lower surface 84 b that is adapted to glide over the snow. The foot enclosure means of the invention comprises a foot enclosure assembly 90 , which includes a snow boot 89 having a pair of magnets 92 affixed to the sole 89 a thereof by any suitable means such as adhesive bonding (FIG. 24 ). Preferably the magnets are received within a pair of generally circular shaped cavities 94 formed in the sole of the boot 90 and are secured in place therewithin by a suitable epoxy resin. Forming an important aspect of the apparatus of this latest form of the invention is the previously mentioned connector means for releasably connecting the foot enclosure assembly 90 to the support base 84 . As best seen by referring to FIGS. 26 and 27, connector frame 86 is of a generally barbell-like configuration and is securely affixed to the upper surface 84 a of support 84 by connector pins 97 . As indicated in FIGS. 26 and 31, second magnets 88 are slidably mounted within the oval shaped openings 87 for movement between a first position shown in FIG. 26 wherein the second magnets are in index with the first magnets 92 to a second position shown in FIG. 31 wherein the second magnets are displaced from the first magnets (see also FIG. 27 ). Forming another extremely important aspect of the apparatus of the present invention is release means for disconnecting the foot enclosure assembly 90 from the connector means. In this latest embodiment of the invention, this important release means includes displacement means for controllably displacing second magnets 88 with respect to first magnets 92 . This novel displacement means here comprises a displacement mechanism generally designated in the drawings by the numeral 100 . Displacement mechanism 100 is operably associated with frame 86 for controllably sliding second magnets 88 within oval-shaped openings 87 from the first position shown in FIGS. 26 and 27, wherein the magnets are substantially aligned with the first magnets disposed within the boot of the enclosure means to a second position shown in FIG. 31, wherein the second magnets are displaced from and misaligned with the first magnets. This important displacement mechanism 100 of the invention here comnprises a driven member 102 which is rotatably connected to frame 86 for rotation between a first and a second position. Operably associated with driven member 102 is a driving member 104 . As best seen in FIGS. 27 and 30, driven member 102 includes a conventional pinion gear 106 and a generally elliptically shaped head portion 108 which is connected to gear 106 . Also forming a part of the displacement mechanism of the invention is a pair of connector links 110 which function to interconnect driven member 102 with second magnets 88 . In the manner presently to be described, connector links 110 function to controllably move the second magnets within oval shaped guide openings 87 between the first and second positions upon rotation of the driven member 102 by the driving member 104 . In the present form of the invention, the driving member includes a rotatable shaft 112 having a rack portion 112 a for engagement with pinion gear 106 in the manner shown in FIGS. 26, 29 and 30 and a finger gripping head portion 114 for gripping by the user of the apparatus to impart rotation to shaft 112 and to pinion gear 106 which is rotatable with a stub shaft 107 carried by frame 86 (FIG. 30 ). As indicated in FIGS. 26 and 30, shaft 112 is of a length such that finger gripping head 114 extends outwardly from frame 86 to enable easy rotation by the user of the apparatus. In operating the unique displacement means of the invention, with head portion 108 of driven member 102 in the longitudinally extending position shown in FIG. 26, rotation of finger gripping head 114 will cause pinion gear 106 along with elliptical head 108 , to rotate into the transversely extending position shown in FIG. 31 . In the present form of the invention the connector links have their inboard ends connected to ends 108 a of elliptical head portion 108 and their outboard ends connected to second magnets 88 in the manner shown in FIGS. 26 and 29. With this construction, movement of shaft 112 and elliptical head portion 108 into the second position shown in FIG. 31 will cause second magnets 88 to slide within oval shaped openings 87 toward the second displaced position shown in FIG. 31 . It is apparent that as the second magnets are moved inwardly within oval shaped openings 87 , they will move out of alignment with magnets 92 and as the second magnets become progressively more misaligned with the first magnets 92 , the holding strength of the cooperating magnets will decrease. Accordingly, the displacement means can be used to controllably adjust the holding power of the magnets and, in turn, the force with which the foot enclosure means is secured to the connector means and to support 84 . It is also apparent from a study of FIGS. 26 and 31 that as the second magnets reach their second innermost position, the gripping power between magnets 88 and 92 will lessen to such and extend that the foot enclosure means can be easily separated from the connector means and from support 84 in the manner shown in FIG. 32 . Accordingly, the novel release means of the invention not only permits adjustment of the holding power of the magnets, it also permits the controlled release of the foot enclosure means from the connector frame. It is to be understood that various mechanisms of a character well understood by those skilled in the art could be used to accomplish a sliding movement of magnets 88 within oval shaped openings 87 . By way of example and not by way of limitation, magnets 88 could be moved from the first to the second position by displacement means comprising a linkage mechanism of the character illustrated in FIG. 33 . More particularly, rather than rotating elliptical-shaped member 108 by means of the finger engaging wheel and gear arrangement shown in FIGS. 24 through 32, member 108 can be rotated by a linkage mechanism 117 of the character shown in FIG. 33 . In this instance the linkage mechanism is carried by a connector frame 119 which is of a slightly different construction and includes a pivot pin 121 to which a driving member of linkage arm 123 is connected. A second linkage arm 125 is pivotally connected to an arm 123 and to member 108 so that a movement of arm 123 from the position shown in the sold lines of FIG. 33 to a position shown in the phantom lines will rotate member 108 into the release position. Other similar mechanical arrangements well known by those skilled in the art could be used to accomplish the movement of elliptical head portion 108 . Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is directed to a propelled vehicle capable of adaptation for off-road use, which use can be recreational. More particularly, the invention is directed to a transmission means enabling the construction and use of such a propelled vehicle. Preferred embodiments of the vehicle resemble a motorised skateboard adapted for off-road use. The present invention is perhaps best described as a powered recreational vehicle. However, it should not be confused with conventional off-road vehicles based on cars, trucks or vans. If any analogy is to be made then it is perhaps best made in comparison with other forms of boarding, with skate boards and snow-boards perhaps being the closest of the known boarding techniques. In the specification, the term ‘vehicle’ is used in the sense of a single person conveyance for use on land. The term ‘on-road’ is used to refer to a vehicle that requires a minimum standard of engine and accoutrements, generally recognised by the issue of a licence by a regulatory authority. The vehicle is then legally authorised to be used on public roads. ‘Off-road’ is used as the term referring to vehicles or use of vehicles in places that are not public roads and where operation of the vehicle requires no regulatory licence for minimum standards. Vehicles that can travel anywhere, on any land surface are vehicles that can cover ‘all-terrains’. Whilst the term ‘board’ is used to refer to a four wheeled platform capable of manual propulsion and of carrying one or more persons, generally for recreational use, the term is not limited to this definition in the specification. The term is also used to refer to a four wheeled, shaped motorised platform capable of travelling over all terrains, on- or off-road; and for uses which are not purely recreational. It is in this encompassing respect that the term ‘vehicle’ is used. 2. Description of the Prior Art While the propelled vehicle of the present invention has been developed primarily for recreational use, it is envisaged that it may also find other uses, which include commercial or semi-commercial uses. However, for simplicity, the description herein is written primarily with the recreational aspects in mind. A major difference between the present invention and the other known types of boarding is the means of propulsion. Snow boarding requires a slope, allowing gravity to propel the snow board and user forward. Surf boarding relies upon a wave while skate boarding relies on the user or an incline to propel the device forward. However, off-road or rugged terrain presents a different set of problems. Regardless of the design or shape of the tyres, attempting to push any form of wheeled board or vehicle across sandy or rugged terrain in the same manner as a skate board is impractical as well as difficult. Accordingly, the present invention incorporates a form of motive means (non-manual) for propelling the vehicle across the ground. Various types of propelled boards have been popular for quite some time. Surf boarding is an extremely popular pastime and is considered to have given rise to skate boarding affording enjoyment to those for which surf boarding was not accessible or practical. However, skate boarding has evolved into a sport of its own. Another off-shoot is snow boarding which has become as popular, if not more popular, than the more traditional types of skiing. These demonstrate an enthusiasm by the public for sport and recreational pastimes based on board-riding. However, there are limitations associated with each of the known types of boarding described above. For instance, surf boarding relies on water as its medium, while snow boarding relies on snow. Skate boarding overcomes some of these restrictions by including wheels for travel though is generally restricted to hard or paved surfaces. However, there is nothing currently available, to the best of the applicant's knowledge, which allows motorised board-riding in off-road conditions. Given that escaping to the country is very popular for many city dwellers, as well as a significant non-urban resident population, there is a significant demand on sport and recreational activities which take place in remote or off-road areas. With this need at least partially in mind, the present invention was developed to enable popular board-riding type activities to take place in off-road conditions. Propelled vehicles, generally described as motorised skateboards, are known. Examples of such can be seen in U.S. Pat. No. 4,073,356 (Schlicht), U.S. Pat. No. 4,094,372 (Notter), U.S. Pat. No. 4,274,647 (Drake Jr), U.S. Pat. No. 5,020,621 (Martin) and U.S. Pat . No. 5,381,870 (Kaufman). Schlicht discloses a motorised skateboard where the drive means is through a fifth wheel which is positioned centrally with respect to the other four wheels. The motor is connected to the fifth wheel. However, the vehicle is not capable of all terrain travel, does not incorporate suspension means, and has primitive steering. In Notter, the motorised skateboard has only two wheels which are capable of being driven via a chain drive. There is no suspension. Drake Jr discloses an articulated, manually steerable skateboard. However, the articulation is required to be between the wheels. This requires that the user manually turn the front portion, via handles which are rigidly secured to the front portion, to steer the board. Such a skateboard does not have any suspension, and could not be capable of use in all terrains. The board disclosed does not include steering by inclination of the user platform of the vehicle. Martin discloses an electrically driven brake for a skateboard in which the motor is connected to two wheels by a belt. Slippage of the belt acts as a clutch means to transfer power to the drive wheels. However, there is no ability for the skateboard to be an all terrain vehicle: there is no suspension nor transmission means. In the patent to Kaufman the motorised skateboard has belt driven rear wheels The front wheels include a shock absorbing suspension. However, the skateboard is not adapted for all terrain travel. However, in all the known motorised boards and the variations. as described above, there is no example of a vehicle that can reliably drive or be driven at the same time as the vehicle turns, as well as do each operation independently on all terrains. Further, in all prior art, the suspension, if present, is a separate mechanism from the drive means and the steering means and is not adequate for all-terrain use. Further, none of the patents discussed disclose provision for free-wheeling assemblies, in connection with the vehicle, when the engine is idling or stopped, or to prevent engine braking during deceleration. Thus no prior art discloses a transmission unit for a vehicle which adequately incorporates transmission, steering, braking, free-wheeling and suspension for use in a vehicle as defined above, where the vehicle is capable of all terrain use. It is an object of the present invention to address the foregoing problems by the provision of a mechanical unit that combines the features of steering, drive, suspension and braking; the unit operating optimally in a motorised vehicle (as defined above). it is a further object of the present invention to provide such a unit that also permits free-wheeling of each wheel and does so without a differential. It is a still further object of the present invention to at least provide the public with a useful choice. Further aspects and advantages of the present invention will become apparent from the ensuing description which is given by way of example only. SUMMARY OF THE INVENTION According to one aspect of the present invention there is provided a transmission unit for a motorised vehicle which includes motive means, said unit including: steering means for guiding the vehicle, whereby said steering means includes steering the vehicle by movement of the weight of the user relative to the centre of the vehicle; means connectable to the motive means for driving the vehicle, said means including free-wheeling clutch means; suspension means; and braking means; wherein said unit is connected between said motive means and at least one axle of the vehicle through a drive shaft; and wherein said steering means is capable of operation concurrently with said driving means. According to another aspect of the present invention, there is provided a transmission unit, substantially as described above, wherein one or more wheels of the vehicle are connected with a free-wheeling assembly allowing coasting of the vehicle when not in controlled acceleration or deceleration. Such assembly may optionally be a free-wheeling hub assembly, or a free-wheeling axle assembly. According to another aspect of the present invention, there is provided a transmission unit, substantially as described above, wherein wheels, associated with both steering and driving of the vehicle, are connected to the engine via either a ball joint or a spherical coupling, in combination with a drive assembly capable of transmitting torque passing through same. According to another aspect of the present invention, there is provided a transmission unit for a recreational vehicle, substantially as described above, wherein the steering means of the recreational vehicle is connected through a front axle assembly of the unit. According to another aspect of the present invention, there is provided a transmission unit for a recreational vehicle, substantially as described above, wherein steering of the recreational vehicle is effected through a rear axle assembly. According to another aspect of the present invention there is provided a recreational vehicle comprising: a user support portion; wheel means enabling the recreational vehicle to travel across the ground; an engine for propelling the vehicle; and said unit as described above. According to another aspect of the present invention, there is provided a recreational vehicle, substantially as described above, wherein the user support portion comprises a platform on which the user may stand. According to another aspect of the present invention there is provided a recreational vehicle, substantially as described above, wherein acceleration and/or deceleration of the recreational vehicle is controlled by a remote control unit in communication with the vehicle. Preferably the remote control unit comprises a hand held unit. More preferably the remote control unit utilises digital proportional control. According to another aspect of the present invention, there is provided a recreational vehicle, substantially as described above, wherein the remote unit is a wireless unit. According to another aspect of the present invention there is provided a recreational vehicle, substantially as described above, wherein the remote control unit is wired to the recreational vehicle. According to another aspect of the present invention, there is provided a recreational vehicle, substantially as described above, wherein all wheels of the vehicle are driven. According to another aspect of the present invention, there is provided a recreational vehicle, substantially as described above, wherein the wheels are adapted for all terrain travel (as hereinbefore defined). Typically, embodiments of the vehicle of the present invention will comprise a supporting platform for a user. The typical and preferred form of riding or driving the present invention is with the user standing—as for other forms of board sports. Accordingly, the supporting portion for a user will typically comprise a platform allowing the user to stand on the device. The user support portion may take many forms. Quite simply it may be a flat platform resembling a skate- or snow-board. Also, means for retaining the feet of the user on the platform are provided, for example, straps. There may be provision for clips or bindings (for example, as used on snow-boards). It is to be noted that due to the nature of the steering and the stability of the vehicle, self release clips, such as used on skis, are not applicable. The platform may be flat, or contoured, and may take the form of a body for the vehicle. However, whatever its configuration, it should be able to support the user, preferably in a stable manner allowing a skilled user to ride and control the vehicle. The user support portion may be in substantially one piece, or may comprise a series of two or more portions or platforms. These may be articulated or otherwise connected with each other. For such embodiments it is envisaged that there will be two such platforms, with each foot of the user being placed on one of the two platforms. This may allow for independent control of certain functions, as will be discussed later herein. Most embodiments of the vehicle of the present invention will also include wheels which are adapted for all types of terrain (as hereinbefore defined). While all-purpose embodiments are envisaged, as with any type of sport or recreational equipment, embodiments soon evolve which are specialised for particular applications. For instance, it is envisaged that there will be embodiments which may be specific for wet or dry sandy conditions while there may be others for grassy or rocky type ground. Also envisaged are different embodiments adapted for use in snow, ice, and/or mud, and other off-road conditions. Other specialised conditions are also envisaged, including paved areas, and the vehicle of the present invention can be especially adapted for use on-road. However, regardless of whether the embodiment is destined for general purpose or specialised use, preferably the wheels are suitable for supporting the vehicle (and user) and for allowing travel across the type of terrain for which the embodiment is envisaged. As it is envisaged that most applications of the present invention will be off-road, wider and/or balloon-type tyres with differing types of tread will be used for most embodiments. A further embodiment of the present invention incorporates a unit and a vehicle having tracks rather than wheels for ground travel. This will typically be more effective on softer types of ground, and represents a further alternative to wheeled embodiments. It is envisaged that some embodiments may be easily modified or converted between wheels and tracks. The motorised vehicle, with appropriate wheels or tracks, may be used in hilly areas, and may be ridden up inclines. In some respects, the present invention incorporates and combines some of the elements associated with off-road trail bike riding and skate boarding. However, problems associated with off-road terrain means that the vehicle of the present invention comprises more than the addition of a motor to a skate board. That such a simple modification would fail to work effectively in off-road situations and would fail to overcome a number of difficulties which will become apparent from the following description. To operate effectively in off-road terrain, it is preferred that embodiments of the present invention have 2-wheel-drive, 4-wheel-drive, or all-wheel-drive. It is envisaged that most embodiments of the present invention will comprise four wheels, typically distributed over two main axle assemblies or groupings. It is possible, however, that other embodiments may have other numbers of wheels and/or axle groupings etc. For simplicity however, the ensuing description will be directed primarily to embodiments having four wheels distributed over front and rear axle assemblies. Steering may be accomplished by a number of different arrangements. In current embodiments of the present invention, steering is accomplished in a manner very similar to a standard skate board, that is, by altering the inclination of the user supporting platform. Typically the steering means is located about the front axle assembly, though it is also envisaged that similar arrangements may also be provided at other wheels/axle assemblies. These similar arrangements may be either in addition to, or instead of, steering arranged about the front axle assembly. Hence, in preferred embodiments, steering is accomplished by altering the forces acting on the user support portions associated with a particular axle assembly. It is also envisaged that other forms of steering the vehicle may be implemented. For example, such forms may include powered steering of the wheels, which steering is controlled other than by altering the inclination of the user support portion. Such steering may be activated by the control means (to be described later) for controlling acceleration and braking. However, to maintain balance, it is generally desirable that steering is controlled by, or includes, altering the inclination of the user support portion or part thereof. There may be modifications or variations to these arrangements. For instance, there may be power assisted steering, which accentuates or augments any sensed alteration of the inclination of the user support portion. Another example is an arrangement to allow steering in response to the actions perceived on one or more input sources. For example, steering by altering the inclination of the user support portion, as well as the steering being controllable from a separate control piece. For such an arrangement, it is also possible that one axle assembly is controlled by one method while the other is controlled by the alternative method. This may also introduce a new element of skill, excitement, and versatility into such embodiments. A further difficulty associated with a combination of 4-wheel-drive or all-wheel-drive and steering is how to transmit drive to wheels which are being driven. In a preferred embodiment of the transmission unit of the invention, this problem is addressed by having ball joint or spherical coupling-type linkages in the axle assemblies associated with steering and providing a drive transmission linkage passing through these assemblies to drive the wheels of the vehicle. This allows for altering the inclination of the user support platform relative to the wheels and axle assembly while still allowing drive to be transmitted to the wheel. It is envisaged that there are other solutions to allow for this which may be incorporated into the present invention, though the foregoing arrangement is adopted in preferred embodiments. Another problem associated with the intended use of the vehicle of the present invention relates to the acceleration and deceleration of the vehicle. There are a number of options available for forward control of the vehicle, one of which is to have the motive means substantially continuously linked to the driving wheels through the transmission unit. Accordingly, by controlling the motor speed, the user may control the speed at which the vehicle travels. However, while this may be suitable for a vehicle whose main function is conveyance, it is perhaps not the most ideal arrangement for a sport/recreational-type vehicle. In addition, it may lead to increased fuel usage, regardless of whether the motive means is a combustible fuel or an electrical storage device. Accordingly, preferred embodiments of the transmission unit of the present invention utilise free-wheeling assemblies for all wheels, enabling the vehicle to coast or free-wheel when not under controlled acceleration or de-acceleration. The free-wheeling assemblies may be optionally free-wheeling hub assemblies or free-wheeling axle assemblies. Either arrangement allows fuel to be conserved by employing the motor only when the user deems it necessary, rather than attempting to drive the vehicle continuously (though the motor may idle when free-wheeling). In addition, the characteristics of the vehicle when coasting or free-wheeling down a slope will be substantially different than when the motor is connected and attempting to brake the vehicle (engine braking). This is one further reason why a free-wheeling transmission arrangement is preferred for many embodiments. A further consideration is the engine or motor itself. This may be any suitable small motor having a varying range of horse powers and motive power according to user preferences or requirements. Preferred embodiments may employ electric or fossil fuel motors, with the primary requirement being that the motor is reasonably compact. An example is a small capacity two or four stroke engine, such as a petrol driven motor, for example, such as is often used on go-carts. Often quite high power outputs are achievable from a small engine capacity and size. Diesel driven engines may also be used. Electric power is also an option, with quite small motors providing high torque and power characteristics. Also, control of electric motors is simpler, though the disadvantage is the weight and size of the energy storage devices. However, recent advances in battery technology have provided high capacity, lightweight batteries (such as are more frequently being used in cellular phones and portable computers) which may be incorporated into the device. Hybrid technologies, for example the diesel-electric motor, may also be employed. Another possibility is the use of a hydraulic pump to drive a hydraulic motor. This also opens up other possibilities, which may also be implemented with some other drive systems. This includes the use of a main engine separate from the vehicle to drive a motor mounted on the vehicle. An example is a backpack, worn by the user, which comprises an engine driving a hydraulic pump. Mounted on the vehicle is a hydraulic motor, powered by a hydraulic line between the pump and motor. Preferably quick-release, automatic close-off connections are used on these connecting lines, should the user and vehicle become separated. The hydraulic pump may be driven by any type of engine technology, including small combustion engines, electric engines, etc. The technique of separately mounted primary engines may also be implemented for other engine technologies. For instance, the diesel-electric arrangement would readily lend itself to such a scenario, with the electric motor mounted on the vehicle, perhaps with a number of batteries as a buffer to satisfy instantaneous or peak demand, and the diesel or other power generator carried remotely. Energy conserving techniques may also be implemented on electric motor embodiments. This includes power-generation during deceleration to charge a storage device. Such techniques are known for conventional electrically powered vehicles. One further advantage of electrically and hydraulically powered motors is their quiet operation which may make their use mandatory in areas having noise control regulations, a problem currently plaguing the use of water borne jet-skis near residential areas. As can be appreciated, varying choices of motive means have different advantages and disadvantages, though all should be considered for varying applications of the present invention. Control of the vehicle, apart from steering, is generally limited to acceleration and deceleration. Acceleration is typically achieved by controlling either or both the motor and transmission means, while deceleration may either rely on engine braking and/or a braking system. Various braking systems are known and may be implemented and will not be described in any detail here. However, envisaged braking systems include in-board disc braking, and various other forms of disc and/or drum braking. Such braking means may be centrally situated or be positioned adjacent the wheels or tracks. Control is preferably via a remote unit in communication with the vehicle. A preferred embodiment utilises a hand operated device, though foot operated controls are also a possibility. Steering is achieved by varying the inclination of the user support platform. However, it has been previously discussed that some steering control may be achieved via a remote controlling unit. Typically the remote controlling unit will at least allow for acceleration, and preferably also braking of the vehicle. The control unit will typically be in communication via a number of means, including wired and wireless communication methods. In a preferred embodiment, the controlling unit relies on proportional digital control, in the same manner as the remote controller for a model aeroplane or model car. However, any number of communication and control methods may be used. Optionally, safety features may be built in. Obviously when other people may be around, the user does not wish an uncontrolled power device to be loose. Accordingly, the control device may incorporate features to shut down and halt the vehicle should the user become separated from the vehicle and/or the remote control unit. This may employ variations of the dead-man's switch. Examples include buttons on the control device which must be continuously pressed for use of the device, with release causing automatic engine shut down and braking of the vehicle. Another example includes plugs or tags attached to the body of the user and plugged into either the vehicle and/or the control unit. When the user is separated from either the vehicle or controlling unit, one portion of the plug becomes separated from the second portion and effects shut down of the vehicle. Such devices may be electrical and/or mechanical in operation. The main features and preferences of the present invention and preferred embodiments of same have been described in general. As can be appreciated, any number of variations of these features may be implemented on other embodiments of the present invention. Further modifications may also be made which do not necessarily alter the fundamental characteristics of the invention. It is considered that such variants and modified embodiments still fall within the scope of the present invention which, in its preferred form, resembles a motorised wheeled board which is ridden in the stand up position. BRIEF DESCRIPTION OF DRAWINGS Further aspects of the present invention will become apparent from the following description, which is given by way of example only and with reference to the accompanying drawings, in which: FIG. 1 is a perspective diagrammatic drawing of a rider using a preferred embodiment of the present invention; FIG. 2 is a plan diagrammatic cut-away view of a preferred embodiment of the present invention; FIG. 3 is a perspective diagrammatic view of the embodiment of FIGS. 1 and 2; FIG. 4 is a side section view of a preferred embodiment of the invention showing two variations of the transmission unit; FIG. 5 is a cut-away perspective view of the same variation of the unit of FIG. 4; FIG. 6 is a second perspective view of the same variation of the unit of FIG. 4; FIG. 7 is a partial section view of one embodiment of the free-wheeling clutch of the present invention; FIG. 8 is a partial section view of a second embodiment of the free-wheeling clutch of the present invention; FIG. 9 is a perspective diagrammatic view of a first preferred embodiment of the hand-piece unit of the present invention; and FIG. 10 is a perspective diagrammatic view of a second preferred embodiment of the hand piece unit of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to the drawings, specifically FIGS. 1 to 3 , and by way of example only, there is provided a recreational vehicle ( 1 ) (as defined above), comprising: a user support portion ( 2 ); wheels ( 3 , 4 ) enabling the recreational vehicle ( 1 ) to travel across the ground; and an engine or motor ( 5 ). FIG. 1 illustrates a preferred embodiment of the vehicle ( 1 ) of the present invention with a user ( 6 ) on board. This is a typically representative stance for the user ( 6 ) when riding the vehicle ( 1 ). Control is achieved by altering the inclination of the platform ( 2 ) upon which the user ( 6 ) stands, with respect to the front wheels ( 4 ) and axle assembly ( 7 ). Also shown in FIG. 1 is a backpack ( 40 ), used on some alternative embodiments of the invention. Housed in such a backpack ( 40 ) is a small hydraulic pump powered by a small combustion engine. This backpack ( 40 ) is connected to the vehicle ( 1 ) by hydraulic lines ( 41 ) which pump hydraulic fluid to a hydraulic motor (not shown) for propulsion of the vehicle ( 1 ). Alternatively, the backpack ( 40 ) may contain a small electric generator, connected by power supply lines to the vehicle ( 1 ), which is propelled by an electric motor. FIGS. 2 and 3 illustrate the preferred embodiment of the transmission unit ( 100 ). Referring to FIGS. 1 to 3 , the unit ( 100 ) includes a front axle assembly ( 7 ) and a rear axle assembly ( 19 ) mounted to the underside of the platform ( 2 ). Connected to the axle assembly ( 7 ) are wheels ( 4 ) with balloon tyres ( 4 a , 4 b ), which are equivalent to the tyres ( 3 a , 3 b ) of the wheels ( 3 ) at the rear of the vehicle ( 1 ). However, in other embodiments, different diameter wheels may be used on front and rear or differing axle assemblies ( 7 , 19 ). Also different styles of wheels ( 3 , 4 ) or tyres ( 3 a and b , 4 a and b ) may be used, if so desired. Desirably, the tyres ( 3 a and b, 4 a and b) are 320 by 190 millimetre balloon tyres. In FIG. 2 and with reference to wheels/tyres 3 b and 4 b , a first preferred means of connection by independent free-wheeling hubs ( 8 ) is shown. Each free-wheeling hub ( 8 ) is connected at one end of the respective axle assembly ( 7 , 19 ). A pivoting mounting arrangement (generally indicated by arrow 9 , and described later) allows for steering of the front axle assembly ( 7 ) as the relative inclination of the platform ( 2 ) alters. A second preferred means of connection and arrangement for the wheels ( 3 , 4 ) is shown in FIGS. 5 or 6 . In this second embodiment, the free-wheeling effect for the wheels ( 3 , 4 ) is achieved by a centrally positioned free-wheel clutch ( 18 ), of known type. A mid-mounted petrol driven engine ( 5 ) is provided and is connected to the wheels ( 3 , 4 ) via the unit ( 100 ). The transmission unit ( 100 ) includes a front, adjustable ratio gearbox (preferably 5% overdriven) with clutch. This gearbox and clutch is labelled ( 10 ) on the drawings. Extending from the clutch and gearbox ( 10 ) is a front drive shaft ( 11 ) which is preferably a low profile high torque unit. To allow for changing inclinations of the front axle assembly ( 7 ) as the vehicle ( 1 ) travels over uneven terrain, and/or steering is attempted by the user ( 6 ), the front drive shaft ( 11 ) connects to a drive and front coupling assembly ( 12 , 13 ), connected to the front wheels ( 4 ) through the front axle assembly ( 7 ). The assembly ( 12 , 13 ) can incorporate a number of different components, in various combinations. Referring to FIGS. 4 to 8 , the various embodiments of the drive assembly ( 12 , 13 ) are thereshown. In FIG. 5, the coupling assembly ( 12 ) includes the above described embodiment of the free-wheel clutch ( 18 ). The clutch ( 18 ) is centrally positioned on the axle ( 117 ). The coupling assembly ( 12 ) further includes a crown wheel ( 119 ), pinion ( 116 ), bearings ( 111 ) and flexible coupling ( 112 ). The coupling ( 112 ) is connected to the drive shaft ( 11 ). The assembly ( 12 ) is of known type. In FIG. 6, the case of the embodiment of the coupling assembly ( 112 ) is shown. The assembly ( 112 ) includes a spherical coupling ( 212 ) connected to the drive shaft ( 11 ). The spherical coupling ( 212 ) is a ball-joint type assembly with drive being transmitted through bearings and gearing within the spherical coupling ( 212 ) and the transmission casing ( 218 ), to the axle ( 117 ). The bearings and gearing (not shown in detail) are of known type. The rear coupling assembly ( 14 ) is shown in FIG. 2 . The assembly ( 14 ) is very similar to the second preferred embodiment of the front assembly ( 112 ). The assembly ( 14 ) comprises a rear clutch and gearbox assembly which is shown as incorporated into the engine ( 5 ). If so desired, the ratio gearbox is adjustable, and includes a pull start mechanism (not shown) for the engine(s). The rear drive shaft ( 16 ) also connects to a spherical coupling unit ( 17 ) including means for transmitting torque therethrough, and is again distributed via a rear axle assembly ( 18 ) to the rear axle ( 118 ). In FIGS. 2 and 4, the unit ( 100 ) is drawn as showing a drive assembly ( 12 , 13 , 14 ) for both the front and back axle assemblies ( 7 , 19 ), providing four wheel drive. However, it will be appreciated that the unit ( 100 ) and vehicle ( 1 ) may be two wheel drive only. In such an embodiment, the rear shaft ( 16 ) would be simply connected to the rear axle ( 118 ) in known manner (not shown). Referring to FIGS. 2, or 6 two embodiments of the braking assembly ( 20 , 120 ) are shown. In FIG. 2, the braking assembly ( 20 ) is hub-mounted and is adjacent the free-wheeling hub assembly ( 8 ). In FIG. 6, the second embodiment of the braking assembly ( 120 ) is centrally mounted. The second braking assembly ( 120 ) incorporates a disc brake rotor ( 121 ), of known type. Referring to FIGS. 7 and 8, two preferred embodiments of the clutch ( 18 ) are thereshown. In FIG. 7 the assembly ( 18 ) includes a ratchet and pawl type of clutch, with an outer ratchet ( 318 ), a pawl ( 319 ), an inner race ( 320 ) and a spring loaded plunger ( 321 ). The assembly moves between a free-wheel position (arrow A) and a locked wheel position (arrow B), in known manner. Referring to FIG. 8, a second embodiment of the clutch assembly includes a roller clutch, with an outer race ( 418 ), a locking roller ( 419 ), an inner race ( 420 ) and a spring loaded plunger ( 421 ). The assembly moves between a free-wheel position (arrow A) and a locked wheel position (arrow B), in known manner. Referring to FIGS. 1 to 3 , 4 and 6 , two embodiments of the front axle assembly ( 7 ) which detail the arrangement for steering assistance are shown. In FIGS. 1 to 3 and 6 , this steering arrangement is generally termed the pivoting mounting arrangement ( 9 ). Referring to FIGS. 4 and 6, the mounting arrangement ( 9 ) includes a rigid flange ( 119 ) connected to the casing ( 18 , 218 ) and front axle ( 117 ) of the assembly ( 7 ). The flange ( 119 ) incorporates a hole therethrough for an upright bolt and nut ( 149 ). The bolt also passes through a hole on the platform ( 2 ). Absorbent bumpers ( 150 ) may be added at least at two or three positions—above the platform ( 2 ) below the nut, below the platform and above the flange ( 119 ), and below the flange ( 119 ), as is desired. The bumpers ( 150 ) are constructed of urethane, or other shock absorbent material. A further embodiment of the mounting arrangement ( 9 ) includes an arrangement of the flange ( 119 ) and bolt and nut ( 149 ) such that the axis of the nut and bolt assembly ( 149 ) passes through the front axle assembly ( 7 ). In one option of the mounting arrangement, as shown in FIG. 4 with reference to the wheel ( 3 a ), an imaginary line (D), about which the platform ( 2 ) pivots, can be drawn between the pivot point ( 151 ) on the platform ( 2 ) and the centre of the spherical coupling ( 212 ). The platform ( 2 ) will pivot about line D, in addition to being able to pivot about the longitudinal axis (C) of the vehicle ( 1 ). Preferably the angle between the lines C and D is between 0° and 45°, preferably 30°. The platform ( 2 ) also, in the illustrated embodiment in FIGS. 1 to 3 , is moulded to form part of the body of the vehicle ( 1 ) and provide a protective covering for the components described above. Mudguards ( 2 a ) may also be fashioned into the platform ( 2 ), though the exact design of the platform ( 2 ) is largely a matter of user choice. Referring to FIG. 1, snow board type bindings and shoes ( 25 ) are also provided at the front and rear of the platform ( 2 ) enabling the user ( 6 ) to engage with the platform ( 2 ). A simpler arrangement, by the provision of front and rear straps (not shown) may be provided, if so desired. Optionally, control of acceleration and deceleration of the vehicle is by a device such as the hand held remote control unit. A first preferred embodiment of such a unit is the control unit ( 30 ) illustrated in FIG. 9 . The unit ( 30 ) comprises two variable position triggers ( 31 , 32 ) to control acceleration and braking, though the exact configuration and arrangement of controls can be adjusted to suit the preferences or requirements of the user ( 6 ). A second preferred embodiment of the control unit ( 130 ) is illustrated in FIG. 10 . As with the first embodiment, the unit 130 includes two variable position triggers ( 131 , 132 ). An engine shut off switch ( 134 ) is included as part of the throttle control ( 131 ). The braking is control by trigger ( 132 ). The preferred method of actuation and control of the control unit ( 30 , 130 ) is via digital proportional control which allows for incremental advance (rather than on/off switching) of the control mechanisms ( 31 , 131 , 32 , 132 ) for the motor and braking assemblies. The method of communication may be via a wired attachment ( 35 , 135 ), or by a wireless mechanism. Typically, acceleration comprises progressive opening of the throttle and differs very little from the techniques used for controlling model aircraft engine speeds. Braking may be achieved in a similar manner, with progressive control of a brake cylinder or brake line, which may be power assisted, to effect closing of the brake pads onto the brake discs. A number of different variations for effecting control of the motor and braking assemblies may be employed, and standard techniques used in the radio control and model fields may be drawn upon and used herein. As can be appreciated, the invention generally described herein may be adapted in a number of ways. However, it is envisaged that many modifications and adaptations may be made to the illustrated design of unit ( 100 ) and vehicle ( 1 ) based on the description given herein, and it is envisaged that these all form part of the present invention. Aspects of the present invention have been described by way of example only and it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/238,228 filed on Aug. 31, 2009, the entire contents of which are incorporated herein by reference. BACKGROUND [0002] 1. Technical Field [0003] The present disclosure relates generally to a port assembly for use in minimally invasive surgical procedures, such as endoscopic or laparoscopic type procedures, and more particularly to a device and a method for introducing an instrument within a body cavity. [0004] 2. Background of Related Art [0005] Minimally invasive procedures are continually increasing in number and variation. In particular, certain techniques involve a surgeon operating through a single entry point, typically a patient's navel by providing a device that permits multiple instrument access through a single incision. These procedures are similar to other laparoscopic surgeries in that the patient is under general anesthesia, insufflated, and laparoscopic visualization is utilized. Since the procedure is performed through the navel, patients benefit from less post-operative pain, fewer complications, and better cosmetic results than is achievable from a traditional multi-port laparoscopic procedure. [0006] Once an incision is made in a patient's skin, typically inferior to the patient's umbilicus, the patient is typically prepared for laparoscopic surgery using the Kelly clamp method. The Kelly clamp method involves spreading, separating, and dividing subcutaneous tissue, i.e., dissection. A surgeon's ability to properly place an access device that provides multiple instrument access through a single incision may be complicated due to the limited length of the Kelly's clamp's arm and handle. Furthermore, since the device is held in the palm of a surgeon's hand, sufficient visibility may not be possible without overly dilating the incision thereby compromising the seal. Improper loading of the Kelly clamp may result in the clamp's tips, typically formed from metal, coining into unintentional contact with the surgical area resulting in injury. Removal of the Kelly clamp after installation of the port may also present similar challenges. SUMMARY [0007] Disclosed herein are devices and methods for introducing a port within a body cavity. [0008] In an embodiment, a method of introducing a port within a body cavity is disclosed including the steps of placing a compressible port into a membrane, the membrane connected to a substantially rigid rod positioned within a lumen of the compressible port; advancing the port into a body cavity by moving the rod axially through the lumen compressing the compressible port into the body cavity, and once the compressible port is in place, removing the rod through the lumen, thereby removing the membrane and leaving the compressible port within the body cavity. The depth of advancement of the rigid tube within the body cavity may be determined and controlled by utilizing tactile feedback features on the rigid tube. The rod may be adapted to advance incrementally through the introducer. The introducer may include a slot adapted to receive an insufflation valve stern. [0009] In another embodiment, a method of introducing a port within a body cavity is disclosed including the steps of placing a compressible port into a membrane, pulling the membrane into a substantially rigid tube, thereby compressing the compressible port and advancing the compressible port into a body cavity, and removing the membrane from the rigid tube while leaving the port within the body cavity. [0010] In still another embodiment, a method of introducing a port within a body cavity is disclosed including the steps of enclosing a compressible port within a vacuum bag, reducing a pressure within the vacuum bag, thereby compressing the compressible port, pulling the bag through a rigid tube inserted into a body cavity, and removing the vacuum bag while leaving the compressible port within the body cavity. [0011] In a further embodiment, a method of introducing a port within a body cavity is disclosed including the steps of enclosing a compressible port within a vacuum bag, reducing a pressure within the vacuum bag relative to a pressure outside of the bag, thereby compressing the compressible port, pulling the vacuum bag containing the compressible port through a rigid tube inserted into a body cavity, and removing the vacuum bag while leaving the compressible port within the body cavity. [0012] In an embodiment, a system for introducing a port within a body cavity is disclosed including a compressible port, an introducer that is substantially rigid, and a rod positioned within a lumen of the compressible port and attached to a membrane attached to a distal end of the rod, wherein the compressible port is coupled to the membrane and adapted to compress and radially collapse into the introducer upon displacing the rod axially through the introducer. [0013] In another embodiment, a system for introducing a port within a body cavity includes an introducer having a proximal end and a distal end, the proximal end having a wider diameter than the distal end, and a compressible port coupled to a membrane, the membrane adapted to pass through the introducer from the proximal end to the distal end and to pass over an exterior of the introducer upon exiting the distal end. The system may have the proximal end of the introducer configured and dimensioned to be recognizable through tactile feedback, thereby allowing a clinician to position the introducer within a body cavity. [0014] In a further embodiment, a system for introducing a port within a body cavity includes an introducer configured and dimensioned to receive a compressible port housed within a vacuum bag, the vacuum bag adapted to create a pressure differential between an interior of the vacuum bag relative to an exterior of the vacuum bag, thereby compressing the compressible port upon reduction of the pressure in the interior of the vacuum bag. The vacuum bag may be adapted to be removed from the introducer after placement of the compressible port within a body cavity. [0015] In a still further embodiment, a system for introducing a port within a body cavity includes placing a distal end of the compressible port within a heat sensitive membrane such that the distal end is compressed upon the application of heat to the heat sensitive membrane. Compression of the distal end of the compressible port facilitates placement of the compressible port within the incision of the patient. Upon satisfactory placement of the compressible port, the membrane may be removed from the surgical site by opening the membrane along a perforation made along a side of the membrane. [0016] The various aspects of the present disclosure will be more readily understood from the following detailed description when read in conjunction with the appended figures. BRIEF DESCRIPTION OF THE DRAWINGS [0017] Embodiments of the disclosure will be described with reference to the accompanying drawings in which: [0018] FIG. 1 is an isometric view of an introducer; [0019] FIG. 2 is an isometric view of a compressible port; [0020] FIG. 3 is an embodiment of a port introducer in accordance with the present disclosure; [0021] FIG. 4A is another embodiment of a port introducer in accordance with the present disclosure shown in a first state; [0022] FIG. 4B is the port introducer of FIG. 4A shown in a second state; [0023] FIG. 5 is yet another embodiment of a port introducer in accordance with the present disclosure; [0024] FIG. 6A is a still further embodiment of a port introducer in accordance with the present disclosure shown in a first state; and [0025] FIG. 6B is the port introducer of FIG. 6A shown in a second state. DETAILED DESCRIPTION [0026] Particular embodiments of the present disclosure will be described herein with reference to the accompanying figures. In the following description, well known functions or constructions are not described in detail to avoid obscuring the present disclosures with unnecessary detail. As shown in the figures and as described throughout the following descriptions, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to the end of the device that is closer to the user and the term “distal” refers to the end of the apparatus that is farther from the user. [0027] An introducer 12 ( FIG. 1 ) is configured and dimensioned to receive a compressible port 10 ( FIG. 2 ), that is formed from a compliant material and has a plurality of throughholes 17 and optionally an insufflation valve stem 20 within one of the throughholes 17 , within the compressible port 10 . The introducer 12 has a funnel shape to facilitate the translation of the compressible port 10 from a larger opening 22 to a smaller opening 23 . The larger opening 22 may be tapered. A slot 19 may be formed along a side of the introducer 12 to accommodate the insufflation valve stem 20 therethrough. Tactile and/or visual indicators placed on the introducer 12 may assist a clinician in determining the relative position of the compressible port 10 therein. Such indicators may include an indicator line 18 a or a bump 18 b. [0028] A port introducer 100 and a method of use will now be described with reference to FIG. 3 . The port introducer 100 includes a vacuum bag 11 adapted to receive the compressible port 10 therein. The vacuum bag 11 includes a valve 16 and a stress concentration line 21 that can be used to separate the vacuum bag 11 by pulling a tab 21 a. [0029] By drawing air out of the vacuum bag 11 through the valve 16 , the volume of the vacuum bag is reduced which in turn causes a corresponding reduction in size of the compressible port 10 placed within the vacuum bag 11 . Once the volume of the vacuum bag 11 containing the compressible port 10 therein has been reduced in size, the vacuum bag 11 may be placed into an introducer, such as introducer 12 described above, that has been placed within an incision made within a patient. To assist in determining the relative position of the compressible port 10 within the vacuum bag 11 and within the incision, the vacuum bag 11 may be formed from a transparent material. Once the compressible port 10 is positioned as desired, the vacuum bag 11 may be removed from the surgical site by pulling the tab 21 a thereby opening the vacuum bag 11 along the stress concentration line 21 while leaving the compressible port 10 within the incision. The compressible port 10 expands to substantially approximate the shape and size of the incision. [0030] Another embodiment of a port introducer will now be described with reference to FIGS. 4A and 4B . A port introducer 200 includes a membrane 13 adapted to grasp the compressible port 10 therein. The membrane 13 has a generally tubular shape and is formed from a flexible material and is configured and adapted to be placed in the introducer 12 . As shown in FIG. 4A , the compressible port 10 may be stored within the introducer 12 in an uncompressed state prior to use. [0031] Deployment of the compressible port 10 is achieved by placing the introducer 12 containing the membrane 13 having the compressible port 10 placed therein within the incision of the patient. The compressible port 10 may be incrementally advanced through the introducer 12 and into the incision by pulling on a distal portion 13 a of the membrane 13 , as seen in FIG. 4B . [0032] In yet another embodiment, a port introducer 300 will now be described with reference to FIG. 5 . As seen in FIG. 5 , a rod R is placed within one of the throughholes 17 of the compressible port 10 . A membrane 14 adapted to grip the compressible port 10 therein is coupled to the rod R such that advancement of the rod R will result in translation of the compressible port 10 . The membrane 14 may be coupled to the rod R at a distal point 25 of the rod R. The port introducer 300 may be placed within the introducer 12 and advanced through the introducer 12 and into the patient's incision by pushing on the rod R. Once the compressible port 10 is positioned as desired with the incision of the patient, the rod R may be removed through the throughhole 17 thereby removing the rod R along with the membrane 14 from the surgical site. [0033] In a still further embodiment, a port introducer 400 including a membrane 40 will now be described with reference to FIGS. 6A and 6B . The membrane 40 has a generally tubular shape and is adapted to shrink in response to the application of heat. The membrane 40 includes a perforation 41 along a side of the membrane 40 . [0034] By placing the membrane 40 around a distal portion 10 a of the compressible port 10 , the distal portion 10 a can be compressed through the application of heat to the membrane 40 . Upon the application of heat to the membrane 40 , the membrane 40 compresses the distal portion 10 a to facilitate placement of the compressible port 10 within the incision of the patient, optionally by translating the compressible port 10 through the introducer 12 . Once the compressible port 10 is in a desired position within the incision, the membrane 40 can be removed by opening the membrane 40 along the perforation 41 allowing the membrane to be removed from the surgical site. Membrane 40 will reduce in size in the radial and axial dimension. [0035] It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an engaging member of a fastening device made of synthetic resin which substitutes for a conventional snap button and ordinary button. 2. Description of the Related Art A conventional engaging member of a fastening device of this kind made of synthetic resin has been disclosed in, for example, Japanese Patent Application Laid-Open No.9-75113. This Laid-Open invention was proposed by the same inventor of the present invention and as for an outline structure of that invention, each ends of two flat plate portions substantially parallel to each other and made of thermoplastic synthetic resin having the same shape are connected integrally with a connecting portion in a substantially U-shaped section. A number of engaging elements are formed in an upright position on the surface of one of the flat plate portions connected with the connecting portion. Additionally, a tab is integrally molded of the same resin material on the connecting portion so as to project outward in parallel to the flat plate portions from the connecting portion. Further, groove-like sewing lines are formed on the surface of each of the flat plate portions along an entire peripheral edge thereof. Because this engaging member of the fastening device is an integrally molded product of thermoplastic synthetic resin, not only its configuration is stable. but also a fashionable product having a desired configuration and pattern can be produced through a single molding process at a low cost. Particularly because this engaging member of the fastening device is molded in a condition in which first and second flat plate portions are maintained in parallel and connected with the connecting portion, the engaging member of the fastening device can be attached to clothes neatly, and positioning of the engaging member of the fastening device is easy. Further, because the tab is integrally molded on the engaging member of the fastening device to project outward from the connecting portion, an operation for opening and closing the engaging member of the fastening device is also easy. However, although of each of the flat plate portions needs to be molded as thin as possible to ensure flexibility of the clothes on which this engaging member of the fastening device is attached, a thinner sewing line is formed along an entire peripheral edge thereof as described above, and therefore, the engaging member of the fastening device is likely to be broken at that portion, which means there is a limit in reducing the thickness of the flat plate portion. Further, as the thickness thereof decreases, it is more difficult to make outlines of the respective flat plate portions correspond to each other when the two flat plate portions are set up on an edge of clothes, so that the aforementioned sewing lines formed on both the flat plate portions often displace from each other. Therefore, it is difficult to sew the engaging member of the fastening device accurately along the same sewing line. Even if the thickness of each flat plate portion is minimized to cope with such a disadvantage, when the engaging member of the fastening device is attached to an edge of clothes, it comes that an edge of the clothes is nipped by two flat plate portions at the mounting portion, so that the portion feels extremely stiff. Although there is no problem in closing the engaging member of the fastening device because it only has to be pressed, particularly upon opening it, unless the opening operation is carried out with a mating female fastening device member being pressed until the opening is finished, the whole engaged portion moves so that it is impossible to make a smooth opening operation. Therefore, upon attaching/detaching the surface engaging member of the fastening device, particularly upon detaching it, it is difficult to detach the entire engaging member of the fastening device all at once, but instead it must be detached with one fastening device member being rolled up, which is a typical attaching/detaching operation for a surface fastener. Further, because the flat plate portion facing the surface of the clothes is sewed along an entire peripheral edge thereof, at the time of the opening operation described above, a shearing force is applied to a sewing yarn sewn perpendicular to the direction of the opening operation, so that the sewing yarn may sometimes be torn by repeated opening operations. What is most difficult to handle of this engaging member of the fastening device is that because the two flat plate portions are of the same shape in a plan view, when this is attached to an edge of the mounting portion of the clothes, the two flat plate portions must be turned outward with respect to the connecting portion so as to open the end portion thereof and then an edge of the mounting portion of the clothes is inserted into this opening. Such a troublesome procedure is needed to attach the engaging member of the fastening device to the clothes. SUMMARY OF THE INVENTION The present invention has been accomplished to solve these problems with some improvements added to the above mentioned engaging member of fastening device, and it is an object of the invention to provide an engaging member of a fastening device integrally molded of synthetic resin which enables sewing thereof to clothes easily and accurately, ensures ease and smoothness in an opening operation of the engaging member of the fastening device even if it is molded relatively thick, and prevents too much force being applied to a sewing yarn by an external force upon the opening operation, thereby ensuring durability and contributes to reduction of production cost. The object is achieved effectively as described below. According to a first aspect of the invention, there is provided an engaging member of a fastening device which is integrally molded with a substantially J-shaped section, comprising first and second flat plate portions substantially parallel to each other and made of thermoplastic synthetic resin material, whose one end portions are connected via a connecting portion, wherein a number of engaging elements are formed on the surface of the first flat plate portion having a larger area such that they are in an upright position, and a groove-like sewing line is formed along an entire peripheral edge portion thereof, a groove-like sewing line whose end portions are open is formed corresponding to part of the sewing line formed on the first flat plate portion on the second flat plate portion having a smaller area, and a tab made of the same resin material is molded on the connecting portion so as to project outward from the connecting portion in parallel to the flat plate portions. On contrary to the engaging member of the fastening device disclosed in the aforementioned patent application, since the engaging member of the fastening device of the present invention has one of two flat plate portions connected via the connecting portion formed shorter, upon attaching it, an edge of the clothes can be inserted between the two flat plate portions easily without opening the two flat plate portions. Further, although the groove-like sewing line is formed along an entire peripheral edge of the first flat plate portion having a larger surface area, the second flat plate portion having a smaller surface area has only a groove-like sewing line, in a U-shape whose end is open at an edge opposite to the connecting portion, formed at a portion overlapping the sewing line formed on the first flat plate portion. Thus, a displacement between the sewing lines of the first and second flat plate portions diminishes so that not only sewing is achieved securely along the sewing line, but also, because the surface of the clothes is directly sewed subsequent to sewing of the second flat plate portion, upon opening/closing the engaging member of the fastening device, particularly upon opening operation, no extra force in the shearing direction is applied to the sewing yarn by the second flat plate portion on contrary to the engaging member of the fastening device disclosed in the aforementioned patent application, so that the sewing yarn is never torn. Further, according to the present invention, because the first flat plate portion having a larger surface area is disposed on a rear surface of an engaging member of the fastening device mounting portion of the clothes, and the second flat plate portion having a smaller surface area is disposed on the front surface of the clothes, a feeling of stiffness of the attaching portion is eliminated on appearance and in substance, providing better looks. Further, even if the thickness of the flat plate portion is increased to some extent, a required flexibility is ensured, thereby the opening operation of the engaging member of the fastening device being carried out smoothly. Preferably, there is provided an engaging member of fastening device, in which a number of the engaging elements are integrally molded on the surface of the first flat plate portion. Further preferably, there is provided an engaging member of fastening device in which a number of the engaging elements are formed integrally on the front surface of a base cloth by knitting and weaving, and a rear surface of the base cloth is fixed to the surface of the first flat plate portions by bonding or the like. In case where the engaging elements are integrally molded with the flat plate portion as mentioned above, productivity is increased thereby leading to reduction of production cost. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view showing a typical embodiment of an engaging member of a fastening device according to the present invention. FIG. 2 is a rear view of the same. FIG. 3 is a side view of the same. FIG. 4 is a sectional view taken along the line II—II of FIG. 1 . FIG. 5 is a sectional view of principal portions upon attaching the engaging member of the fastening device. FIG. 6 is a front view showing an example of clothes having the engaging member of the fastening device of the present invention. FIG. 7 is a sectional view of principal portions of the engaging member of the fastening device upon attaching, according to other embodiment of the present invention. FIG. 8 is a partial side view showing a modification of the aforementioned embodiment. FIG. 9 is a partial front view showing another modification of the aforementioned embodiment. FIG. 10 is a sectional view taken along the line III—III of FIG. 9 . DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the preferred embodiments of the present invention will be described specifically with reference to the accompanying drawings. FIG. 1 is a front view of an engaging member of a fastening device according to this embodiment, FIG. 2 is a rear view thereof, FIG. 3 is a side view thereof, FIG. 4 is a sectional view taken along the line II—II of FIG. 1 and FIG. 5 is a sectional view showing an example of use style of the engaging member of the fastening device. An engaging member of a fastening device 10 according to this embodiment comprises a first flat plate portion 11 having a substantially rectangular shape, a second flat plate portion 12 of a rectangular shape having a long side having the same length as a short side of the first flat plate portion 11 and a short side substantially ⅕ of the length of the long side of the first flat plate portion 11 and a connecting portion 13 for connecting a short side edge of the first flat plate portion 11 with a long side edge of the second flat plate portion in a parallel manner and with a predetermined gap, and a side view of an entire shape thereof is substantially J shaped. According to this embodiment, a tab 14 is provided on the connecting portion 13 such that it projects outward in parallel to the first and second flat plate portions 11 and 12 . The aforementioned gap between the first and second flat plate portions 11 and 12 is determined arbitrarily depending on the thickness of a mounting portion of clothes on which the engaging member of the fastening device 10 of the present invention is to be mounted. As shown in FIGS. 2 and 3, a number of engaging elements 15 are formed so as to project in plural rows on the surface (rear surface of the engaging member of the fastening device 10 ) of the first flat plate portion 11 . The engaging element 15 of this embodiment is in a hook shape having a standing portion 15 a standing up from the second flat plate portion 12 as shown in FIG. 3 and an engaging portion 15 b extending outward in a curved shape from a front end of the standing portion 15 a . In the example shown in the drawing, all of the engaging portions 15 b extend in the same direction. Further, because the respective hook-shaped engaging elements 15 are formed such that front ends of the engaging portions 15 b are directed in an opposite direction to the projecting direction of the tab 14 , an engaging strength thereof with a mating fastening device member 20 having a number of loop pieces 20 a as shown in FIG. 5 is strongest in a single direction which is opposite to the extending direction of the curved engaging portion 15 b . In addition, a continuous groove portion 11 b serving as a sewing portion is formed along an entire peripheral edge of the surface of the first flat plate portion 11 . Although this groove portion 11 b is not necessary if a thickness of the first flat plate portion 11 does not affect sewing operation, it is preferable to form the groove portion 11 b even if it is a very small one, so that a sewing line can be recognized. Various kinds of decorative patterns may be formed on the surface of the second flat plate portion 12 although not shown in the Drawings. Preferably, this pattern should be formed at the same time when this plate portion is molded, but it can be formed with various welders or prints after the plate portion is molded. A groove portion 12 b is formed on the surface of the second flat plate portion 12 in a U-shape along a sewing line corresponding to part of the aforementioned groove portion 11 b formed on the surface of the first flat plate portion 11 . That is, as shown in the drawing, the groove portion 12 b is formed continuously along the edge connected by the connecting portion 13 of the second flat plate portion 12 and both right and left edges across said edge, and a distal end thereof extends up to an edge opposite to the connecting portion 13 of the second flat plate portion 12 , serving as an open edge 12 b′. The engaging member of the fastening device 10 of this embodiment having such a structure can be molded simply in a single process of, for example, injection molding. That is, a movable die (not shown) has a cavity for molding the first flat plate portion 11 , a number of the engaging elements 15 and a part of the connecting portion 13 , and on the other hand, a fixed die has a cavity for molding an external shape of the second flat plate portion 12 , decorative pattern and a part of the connecting portion 13 . Additionally, a plate-like insert die having a predetermined thickness is placed between the fixed die and movable die. With injection molding die having these dies, the engaging member of the fastening device can be easily molded. Since a cavity for the hook-shaped engaging element 15 cannot be cut into a single die surface because of its configuration, all or partial shape of the cavity is formed in an end face of plural thin sheet materials and by overlaying these sheet materials in an appropriate combination, the cavity for the hook-shaped engaging element 15 is formed. Although a molded product may be pulled out directly from the aforementioned hook-shaped cavity with such a release member as an ejector pin (not shown), it may be separated easily by separating the aforementioned plural thin sheet materials in direction of sheet thickness with appropriate means. To attach the engaging member of the fastening device 10 of this embodiment having such a structure to clothes or the like, with the tab 14 outside as shown in FIG. 5 and a face of which each of the engaging elements 15 project facing inner side of the clothes, for example, an outer skirt edge 30 a of a fly portion of a ski wear 30 shown in FIG. 6 is sandwiched by the first and second flat plate portions 11 and 12 , the engaging member of the fastening device 10 is set up at a predetermined position and sewed along the groove portion 11 b with sewing yarn 16 . The engaging member of the fastening device 10 may be adhered with adhesive instead of sewing. In case of attaching by adhering, the groove portion 11 b is also preferred to be formed for the reason described later. On the other hand, a mating fastening device member 20 having a number of loop pieces 20 a which engages with/disengages from the engaging member of the fastening device 10 is attached on an inner skirt edge 30 b of the aforementioned fly portion by sewing or bonding corresponding to the mounting position of the engaging member of the fastening device 10 as shown in FIG. 5 . When the upper skirt edge 30 a of clothes is inserted into a gap between the first and second flat plate portions 11 and 12 of the engaging member of the fastening device 10 of this embodiment, contrary to the engaging member of the fastening device described under the aforementioned Patent Number, because of substantially J-shaped cross section, the upper skirt edge 30 a of clothes can be inserted easily without opening an opening end thereof. Further, because the mounting posture of the engaging member of the fastening device 10 is automatically determined by bringing an insertion end thereof into contact with an inner wall of the connecting portion 13 , the engaging member of the fastening device 10 can be attached neatly. Further, because the engaging member of the fastening device 10 is fixed such that at least the edge of the clothes of the mounting portion is nipped by the first and second flat plate portions 11 and 12 and connecting portion 13 , separation never occurs between the clothes edge and each edge of the engaging member of the fastening device 10 , and further, because the tab 14 extending outward from the connecting portion 13 is provided, durability and operability for opening/closing are secured. Because the extending length of the second flat plate portion 12 from the connecting portion 13 is by far shorter than the extending length of the first flat plate portion 11 , a displacement is not likely to occur between the edges of the first flat plate portion 11 and second flat plate portion 12 , and therefore, a displacement of the groove portions 11 b and 12 b for forming the sewing lines on the surfaces of the respective flat plate portions 11 and 12 can be minimized. Thus, only if sewing is carried out along the groove portion 11 b of the first flat plate portion 11 as described above, the engaging member of the fastening device 10 is automatically sewed along the groove portion 12 b of the second flat plate portion 12 existing on a rear surface across a clothes, ensuring a beautiful finish. Further, the groove portion 12 b for determining the sewing line formed on the second flat plate portion 12 is formed in a U-shape corresponding to the sewing line corresponding to part of the groove portion 11 b formed on the surface of the first flat plate portion 11 as described above, and a distal end of the groove portion 12 b is open. Therefore, a sewing yarn to be sewn along the groove portion 11 b left in the first flat plate portion 11 is sewed directly on clothes or the like on the side of the second flat plate portion 12 . According to the prior art, when the engaging member of the fastening device 10 is separated from the loop pieces 20 a of the female engaging member of the fastening device member 20 to open the engaging member of the fastening device 10 , too much force is applied in a shearing direction on sewing yarn portion which is to be fixed perpendicular to an opening direction of a portion opposite, in particular, to the connecting portion of the second flat plate portion which is fixed by the sewing yarn along the entire peripheral edge. However, with the aforementioned structure, because the sewing yarn sewed perpendicular to the separation direction is sewed directly to clothes and the second flat plate portion 12 which should be fixed by the sewing yarn does not exist, no such extra force is applied so that the clothes or sewing yarn is unlikely to be torn. FIG. 6 shows an appearance of a ski wear to which the engaging member of the fastening device 10 of the present embodiment and a mating fastening device member (not shown) are attached. When the engaging member of the fastening device 10 is pressed against the mating fastening device member 20 attached to a position corresponding to the first flat plate portion 11 of the engaging member of the fastening device 10 of the present invention, both engage each other easily so that the fly portion shown in the drawing is closed. Because the engaging portions 15 b of all the hook-shaped engaging elements 15 are directed toward an opening direction of the fly portion according to this embodiment, even if a strong external force is applied in a sliding direction so as to open the fly portion, the loop pieces 20 a act in a shearing direction of the standing portion 15 a of the hook-shaped engaging elements 15 , that is, a direction of a maximum engaging strength, so that the engaging member of the fastening device 10 will not easily disengage. In the closed condition, as shown by a fading line of FIG. 5, there is a gap D between the tab 14 of the engaging member of the fastening device 10 and an inner half portion of the fly portion, and therefore it is easy to insert a finger into this gap D thereby facilitating a separating operation for separating the engaging member of the fastening device 10 from the mating fastening device member 20 . In this closed condition, if the tab 14 is picked and the engaging member of the fastening device 10 is operated in the separation direction (downward in FIG. 5 ), a sufficient flexibility is ensured as compared to a case in which both surfaces of the clothes are nipped by the first flat plate portion 11 and second flat plate portion 12 like the prior art, because most attaching portion is fixed to a single surface of the clothes by the first flat plate portion 11 . As a result, smooth separation is possible. FIG. 7 is a sectional view showing a mounting state of the engaging member of the fastening device 100 of another embodiment of the present invention. According to the drawing, the tab 104 projected from the connecting portion 13 is projected on an extension line of the second flat plate portion 12 and a projection 104 a is projected in a hook shape at a distal end to be directed toward the first flat plate portion 11 . Instead of the projection 104 a , it is permissible to form a cylindrical portion. When a concave portion or a cylindrical portion is formed on the tab 104 , the tab 104 is easy to pick with fingers, thereby making the opening and closing operation accurate and easy. According to the present invention, the hook directions of all the hook-shaped engaging elements 15 do not always have to be equal as the above mentioned embodiment, but for example, it is permissible to make the hook directions of hook-shaped engaging elements 15 disposed on adjacent rows opposite to each other. In this case, a necessary engaging force can be secured in any direction on the fly portion. Further, according to the present invention, it is possible to mold a flat surface 12 a leaving the groove portion 11 b on the surface of the first flat plate portion 11 , and bond with adhesive for example, an ordinary fiber-made surface engaging member of the fastening device of a similar shape as the first flat plate portion 11 and having hook pieces of ordinary monofilaments on the surface of woven or knitted base cloth to the flat surface of the first flat plate portion 11 with adhesive for example, without molding the hook-shaped engaging elements 15 integrally on the surface of the first flat plate portion 11 . FIG. 8 shows a first modification of the aforementioned embodiment. A rib 12 c is provided on a back side of a free end portion of the second flat plate portion 12 so that it extends along an edge thereof as shown in this drawing. With such a structure, when an edge of clothes or the like is nipped between the first flat plate portion 11 and second flat plate portion 12 , the aforementioned rib 12 c holds the nipped end of the clothes by pressing, thereby preventing a displacement of the clothes or the like upon sewing. FIGS. 9 and 10 show still another modification of the present invention. According to this modification, an opening end 12 b ′ of the groove portion 12 for forming the sewing line of the second flat plate portion 12 is formed slightly thicker so as to form a reinforcing portion 12 d . A width thereof in the sewing direction is preferred to be equivalent to a single seam. By forming the reinforcement portion 12 d in this manner, it prevents a fracture of the opening edge 12 b ′ of the groove portion 12 b by a sewing thread which may occur because the opening edge 12 b ′ is thin.

1a

CROSS-REFERENCE TO RELATED PATENTS [0001] This application claims the benefit under 35 U.S.C. 119(e) of U.S. provisional application Ser. No. 61/337,989 filed Feb. 12, 2010, which is incorporated by reference herein in its entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] Not Applicable BACKGROUND OF THE INVENTION [0003] 1. Field of the Invention [0004] This invention pertains generally to respiratory ventilation devices with a constant flow pulmonary modulator and equipped with a manually actuating feature, and more specifically to respiratory ventilation devices with a constant flow pulmonary modulator, as described in U.S. Pat. No. 6,067,984, equipped with a feature to allow the clinician or user to easily manually activate inhalation, thus allowing a user to: 1. cycle the device and initiate inhalation immediately in the event that the device stops providing ventilatory supports and “stalls”; 2. detect if the device is automatically cycling or if the patient is triggering the device; 3. synchronize ventilation with other medical procedures; 4. increase Positive End Expiratory Pressure (PEEP) beyond the intrinsic design value for a given Peak Inspiratory Pressure (PIP) setting; and/or 5. provide an inspiratory hold when desired. [0005] 2. Description of the Background Art [0006] A fundamental aspect of providing respiratory care to a patient is the ability to provide ventilatory support to patients requiring respiratory assistance. Ventilatory support is typically provided by clinicians through the use of a manual resuscitator or an automatic ventilatory device. [0007] Manual resuscitators are typically equipped with a self-inflating bag, a set of check valves which control the direction of inhalation and exhalation gases, and a patient interface which is usually either a face mask or a port for connection to and endotracheal tube. Manual resuscitators are usually supplied with a continuous flow of gas containing a known percentage of oxygen. The operator of a manual resuscitator inflates the patient with oxygen enriched air by squeezing the self-inflating bag thus applying pressure and causing gas to flowing into the patient's lungs. Inhalation ends and exhalation begins when the operator stops squeezing the bag, allowing the pressurized gas in the patient's lungs to escape to the ambient environment. Most manual resuscitators are equipped with the means to maintain a small minimum positive pressure on the patient's lungs throughout exhalation commonly called Positive End Expiratory Pressure (PEEP). During exhalation, the self-inflating bag re-inflates and process may be repeated. Manual resuscitators are simple, inexpensive, and are easy to coordinate ventilation with other medical procedures. Unfortunately, manual resuscitators are easy to misuse. A large number of studies have been published which show that irregardless whether the operator of the manual resuscitator is a physician, respiratory therapist or nurse, patients receive volumes of gas per breath (tidal volume) which are too small and respiratory rates which are too quick. This has been shown to create significant adverse effects on patients. [0008] Automatic ventilatory devices (ventilators) were originally developed to deliver a set amount of volume to the patient in a set amount of time which little patient monitoring capability. In the last 25 years different modes, including pressure control, and increased monitoring capabilities have been added, leading to the modern transport ventilators of today. Most ventilators still use volume and time cycled ventilation modes which operate by delivering to the patient pre-set amount of volumes or constant flow for pre-set amounts of time, regardless of the patient's lung compliance. Lung compliance is prone to sudden changes during transport, potentially causing patient airway pressures to increase to the point that they will severely injure the patient. Pressure cycled ventilation and pressure control are newer modes of ventilation used to deliver ventilatory support to the patient and which have a number of distinct advantages over volume and time cycled ventilation modes. Pressure cycled ventilation functions by switching to exhalation from inhalation when a certain pressure is reached, regardless of the volume delivered; thus volumes of gas delivered to the patient vary with variances in lung compliances, preventing the patient from receiving a harmful amount of pressure and insuring appropriate ventilation of the patient. [0009] Modern transport ventilators are battery of pneumatically powered and equipped with numerous ventilation modes, including pressure cycled types of ventilation, various flow control functions, multiple alarm monitoring functions and are also capable of detecting and synchronizing with the patient's breathing efforts. Although current transport ventilators provide consistent, safe and reliable ventilation, they are extremely expensive. Additionally, the disposable accessories that are required to be used with these ventilators can sometimes cost as much or more than a manual resuscitator. To reduce the high capital costs of these devices, some manufacturers have returned to offering simplified time cycled volume ventilators without any of the standard monitoring, control and alarm features of typical ventilators, nor the option of pressure cycled ventilation. These devices are often classified as automatic resuscitators and, in addition to not being as safe, still cost thousands of dollars and require the use of additional disposable or parts which require sterilization before being reused. In today's environment of medical cost containment, hospitals and other medical providers have, for the most part, balked at the cost of transport ventilators and the training of additional personnel it would require. [0010] A Pulmonary Modulator Apparatus (PMA), as described in U.S. Pat. No. 6,067,984 and included herein by reference in its entirety, has been shown to successfully solve the consistency problem of manual resuscitators and the capital expense issues of transport ventilators. Unfortunately a PMA has a number of problems: 1. it can stop cycling due to physiological, mechanical, pneumatic, or environmental changes; 2. it can be hard or impossible for a user to determine if the device is automatically cycling or if the patient is initiating breathing thus increasing the work of breathing for the patient; 3. it is limited to delivering a set level of PEEP that is a constant ratio of PIP; and 4. it has no means of providing an inspiratory hold. [0011] As described in U.S. Pat. No. 6,067,984, a pressure pulmonary modulator apparatus (PMA) comprises a dual area piston (or diaphragm) having a surface area that rests against an interior end of a inlet chamber, thus sealing the inlet chamber during the inhalation phase of the patient. The dual area piston comprises a primary area defined as the area exposed to the patients pulmonary capacity during inspiration when the piston is in the closed position, and a much larger area which comprises the entire area of the piston which is in fluid communication with the patients pulmonary capacity only during discharge or when the piston is in the open position. When the dual area piston is closed, it prevents compressed gas from escaping and causing the lungs to become charged by the incoming compressed gas. During charging (i.e. inspiration), the pressure in the patients lungs increases until the force of the pressure on the primary area of the dual area piston overcomes the restorative force of the piston. Once the dual area piston begins to open, the full area of the piston is exposed to the pressure of the patient's lungs causing the piston to move away from the interior end of the inlet chamber to a fully open position almost immediately. The patient's lung pressure that causes the piston to move into the fully open position is the patient's peak inspiratory pressure (PIP), which is adjustable by controlling the restorative force on the piston. Once the piston opens, it will remain open until the patient's lung pressure drops to a value small enough such that the restorative force overcomes the force of the patient's lung pressure on the full area of the piston. During discharge, the exhaled gases pass by the piston and out of the system through an adjustable flow restrictor (i.e. the rate dial) used to control the rate at which discharge gases are vented into the atmosphere, resulting in the control of discharge duration. The rate dial is essentially a valve, and resistance to exhalation flow is realized by screwing or adjusting the rate dial in our out. Greater resistance to flow results in slower exhalation flows and longer exhalation times. Once the patients lung pressure drops to a value low enough to allow the force of the spring to push the piston closed, the discharge ends and the cycle is repeated. [0012] The patient may spontaneously breathe by triggering the inhalation prior to the end of exhalation. A one-way valve may optionally be provided to increase the ease of the patient's inhalation. Under such circumstances, a new inhalation will start when the patient breathes in, reducing the patient's airway pressure and causing the piston to close and a new inhalation period to start. In addition, the apparatus can be adapted to function as a positive pressure aerosol device by attaching a nebulizer assembly to the inlet chamber of the apparatus. Such a device is useful to those needing the therapeutic effects of aerosol in addition to ventilatory support. [0013] From time to time it may be useful to put the PMA into a “spontaneous mode” in which inspiration starts only after the patient has initiated it by drawing a breath. This mode is achieved by dialing the rate dial to such a position that the restriction to flow for the set flow of gas provided creates an internal pressure great enough that it maintains a greater force on the open piston/diaphragm than the restorative spring force. In such a condition inhalation is initiated by the patient inhaling enough gas that the pressure drops and the restorative force of the spring causes the piston/diaphragm to close. [0014] A PMA can stop cycling, and thus stop providing ventilatory support to a patient, due to physiological, mechanical, pneumatic, or environmental changes. Although this has the benefit of alerting the clinician that the situation is changing, the condition is ultimately highly undesirable because the patient still needs ventilatory support and the only manner that ventilatory support may be provided by existing PMAs is by the clinician determining what change occurred and changing the baseline settings of the PMA to compensate. Determining what change occurred can be time consuming, and if the patient is not being provided ventilatory support, clinicians are rushed and almost always don't have the time. Furthermore, changing the baseline settings of the PMA is often undesirable because it creates a greater degree of uncertainty in a situation that may still be varying and problematic, thus re-stabilizing the patient becomes more difficult. Therefore there is a need for a device with the advantages of a PMA that has the further capability of delivering temporary or alternate ventilatory support regardless of physiological, mechanical, pneumatic, or environmental changes and without changing the baseline settings of the PMA. [0015] Under most circumstances, a PMA is used with a patient who is unconscious and paralyzed due to the administration of medication by the clinician. The sedation of the patient is necessary because it mitigates the risk that the patients will become hypertensive and fight the ventilatory support of the PMA, or that the patient will simply begin to hyper-ventilate. Maintaining the patient in a sedated state can sometimes be problematic because the effects of the medication can subside, or if the medication has just recently been administered, it will take time for the medication to take effect. Much of the time patients are transitioning from one sedated state to another. In the interests of stabilizing the patient, insuring that the work of breathing is appropriate for the patient, and allowing the clinician to address other possible patient conditions, it is important for the clinician to be able to determine if the patient is truly sedated, and that the breathing of the patient is purely caused by the PMA, or if the patient is still semi-active on a respiratory basis and is triggering the device with slight inhalation efforts. Determining which state the patient is in is very difficult to do with the existing PMA design because it is impossible to tell if the patient or the device is causing the cycling of the PMA. Therefore there is a need for a device with the advantages of a PMA that has the additional capability of providing some feedback to the clinician on the sedative state of the patient. [0016] Current PMAs have an intrinsic design PEEP for any set PIP. Since some patients may require additional PEEP beyond what is provided for a set PIP, this is a serious limitation of the PMA. Currently, the PMA may be set to deliver an increased PEEP by adjustment of the rate dial or by increasing flow, but this places the device in a mode that will not cycle unless initiated by the patient which is clearly undesirable the vast majority of the time because it increases the work of breathing of the patient and the patient may simply be unable to make the respiratory effort. The situation can be rectified by addition of an in-line PEEP valve placed between the inlet of the modulator and the patient's airway, but this adds to the cost and clumsiness of the device, and is not practical since additional PEEP is only needed sometimes and as a result clinicians are not likely to keep such devices on hand. Therefore, there is a need for a device with the benefits of existing PMAs that had the additional capability of delivering more PEEP when desired. [0017] Sometimes there is a need for the clinician or user to create an inspiratory hold which is effectively a pause at approximately the peak pressure of inspiration before the initiation of exhalation, or to simply suspend ventilatory support temporarily. An inspiratory hold (clinically also sometimes referred to as sigh breath) can provide important physiological support of certain types of patients. A pause in ventilatory support can provide a needed opportunity for a clinician to perform a needed procedure without the interference of on-going ventilation. Current PMAs do not have this capacity without inducing major clinical inconvenience and disturbance. One method currently employed using existing PMAs is to create a condition in which the entire exhalation path is occluded, potentially leading to damaging pressure levels, and failing to provide a sustained pressure level support. Another is to remove the modulator from patient tee thus eliminating any pressure support of the patient and risking alveolar collapse. Therefore, there is a need for a device with the benefits of existing PMAs that has the additional capacity of delivering an inspiratory hold, or ventilatory pause, in a manner that will limit the pressure level and will not entirely occlude the exhalation path of the patient. [0018] In the pre-hospital environment, many of the Emergency Medical Technicians (EMTs) servicing patients during emergency calls do not have the same sophistication and training as Respiratory Therapists and clinicians in the hospitals. As a result, there is sometimes a reluctance to employ existing PMAs because there is a fear that the EMT may face a situation in which they are not entirely sure what the most appropriate adjustment would be in the event that the PMA stops delivering ventilatory support for mechanical or physiological reasons. Existing PMAs don't have any readily available way to provide these clinicians with a simple back up plan in such event. Therefore, there is a need for a device with the benefits of existing PMAs that has the additional capacity of providing a simple back up plan to clinicians unsure of the changing situation they may be facing. [0019] The present invention has all the benefits of existing PMAs with the added benefit of solving the previously described problems. Specifically the current invention has the advantage that it will: 1. deliver immediate manually triggered ventilatory support regardless of any changes that may have stopped the PMA from automatically cycling (i.e. delivering automatic ventilatory support); 2. provide valuable feedback to the clinician on the sedative/conscious state of the patient; 3. deliver more PEEP than the intrinsic design PEEP of the PMA for the given PIP and flow setting; 4. deliver an inspiratory hold, or ventilatory pause, in a manner that will limit the pressure level and will not entirely occlude the exhalation path of the patient when desired by the clinician; and 5. provides a simple back up plan that still provides ventilatory support to patients for clinicians unsure of the mechanical and physiological situation they are facing. SUMMARY OF THE INVENTION [0020] The present invention generally comprises a pressure pulmonary modulator apparatus which will inflate and discharge any respiratory gas from a patient for a wide range of frequencies when provided with a constant flow of gas and which also has the ability to immediately provide inhalation support to a patient at a limited finite level of pressure whenever manually actuated by the clinician while requiring no more parts or cost than existing PMAs. [0021] An object of the invention is to provide a simplified ventilator apparatus for providing constant flow, pressure cycled ventilatory support to patients and that allows immediate manual initiation of inspiration support. [0022] Another object of the invention is to provide a simplified ventilator apparatus that provides constant flow, pressure cycled ventilatory support and that allows for easy detection of the sedative state of the patient. [0023] Another object of the invention is to provide a simplified ventilator apparatus for providing constant flow, pressure cycled ventilatory support and that allows for easy detection of whether the device is in an automatic cycling or spontaneous mode. [0024] Another object of the invention is to provide a simplified ventilator apparatus for providing constant flow, pressure cycled ventilatory support to children and adults in an emergency situation that allows for higher PEEP settings. [0025] Another object of the invention is to provide a simplified ventilator apparatus for providing constant flow, pressure cycled ventilatory support to children and adults in an emergency situation that allows the clinician or user to hold a longer inspiration time. [0026] Another object of the invention is to provide a ventilator apparatus which is disposable and inexpensive. [0027] Another object of the invention is to provide a ventilator apparatus which allows for the adjustment of peak pressure, positive end expiratory pressure, inspiration duration, and expiration duration. [0028] Another object of the invention is to provide a ventilator apparatus which can allow the patient to trigger mandatory breaths or to breathe spontaneously. [0029] Another object of the invention is to provide a ventilator apparatus which can allow the patient to breathe spontaneously entirely, with manual interjections of inspiration by the clinician or user. [0030] Another object of the invention is to provide a ventilator apparatus which allows inhalation to be initiated by the operator of the apparatus. [0031] Another object of the invention is to provide a ventilator apparatus which can be equipped, or have a built-in high pressure pop-off valve as a safety feature to prevent the unintended build up of patient airway pressure due to malfunction or misuse. Such a high pressure pop-off valve may be equipped with the means to produce an audible tone which will notify an operator that the patient is experiencing high airway pressures. [0032] Another object of the invention is to provide a ventilator apparatus which can be easily used in conjunction with a nebulizer to deliver intermittent positive pressure aerosolized medication to the patient at high and low respiratory rates. [0033] Another object of the invention is to provide a ventilator apparatus which can deliver ventilatory support to patients being transported within or between hospitals. [0034] Another object of the invention is to provide a ventilator apparatus which can be used to treat patients suffering from sleep apnea. [0035] Further objects and advantages of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon. BRIEF DESCRIPTION OF THE DRAWINGS [0036] The invention will be more easily understood by a detailed explanation of the invention including drawings. Accordingly, drawings which are particularly suited for explaining the inventions are attached herewith; however, it should be understood that such drawings are for descriptive purposes only and as thus are not necessarily to scale beyond the measurements provided. The drawings are briefly described as follows: [0037] FIG. 1 is a perspective view of a pressure modulator apparatus in accordance with the present invention. [0038] FIG. 2 is an exploded perspective view of the apparatus shown in FIG. 1 . [0039] FIG. 3 is a sectional view of the apparatus shown in FIG. 1 . [0040] FIG. 4 is an exploded perspective view of the apparatus shown in FIG. 1 and a patient tee adapter in accordance with the invention adapted to function as a resuscitation device with a face mask shown in phantom. [0041] FIG. 5 is an exploded perspective view of patient tee adapter shown in FIG. 4 . [0042] FIGS. 6A and 6B are an exploded perspective view of a pressure modulator apparatus in accordance with the present invention. [0043] FIG. 7 is a sectional view of a pressure modulator apparatus in accordance with the present invention. LIST OF REFERENCE NUMERALS [0000] 10 Pressure Modulator Apparatus 12 Diaphragm Assembly 14 Inlet Chamber 16 Flow Restrictor Conduit 18 Pressure Dial 20 Rate Dial 22 Modulator Housing 24 Modulator Base 26 Diaphragm Plate 27 Diaphragm Ring 28 Interior End 30 Spring 32 Spring Boss 34 External Threads 36 Internal Threads 38 Pressure Dial Boss 40 Cylindrical Sleeve 42 Primary Modulator Chamber 44 Equalization Conduit 46 Secondary Modulator Chamber 48 Safety Discharge Orifice 50 Rate Dial Exhaust Port 52 Flow Restrictor Valve Seat 54 Slots 55 Tapered Inner End 56 External Threads 58 Internal Threads 60 Rate Dial Boss 62 Sealing Ring 64 Ambient Actuation Conduit 66 Patient Adapter 68 Attachment Port 70 Pop-Off Valve 70 Pop-Off Valve 72 Patient Demand Valve 74 Gas Inlet Port 76 Patient Connection Port 80 Flapper 82 One-Way Valve Port 84 Valve Body 86 Face Mask 88 Pop-Off Spring 90 Pop-Off Piston 92 Pop-Off Housing 94 Piston Ring 96 Piston Seal 98 Piston Base 100 Piston Ring Orifice 102 Piston Seal Orifice 104 Piston Base Orifice 106 Second Pressure Dial 108 Ambient Actuation Conduit 110 Third Pulmonary Modulator Apparatus 112 Long Diaphragm 114 Outer Spring 116 Sealing O-ring 118 Equalization Conduit 120 Ambient Actuation Conduit 122 Third Pressure Dial 124 Third Inlet Chamber 126 Third Modulator Body 128 Primary Modulator Chamber 130 Secondary Modulator Chamber DETAILED DESCRIPTION OF THE INVENTION [0107] While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment of the invention, with the understanding that the present disclosure is to be considered as an exemplification of the invention, and is not intended to limit the invention to the specific embodiment illustrated. [0108] For illustrative purposes the present invention is embodied in the apparati generally shown in FIG. 1 through 7 . It will be appreciated that the apparatus may vary as to configuration and as to details in the parts without departing from the basic concepts as disclosed herein. [0109] Referring first to FIG. 1 , FIG. 2 , and FIG. 3 a constant flow, pressure modulator apparatus 10 in accordance with the preferred embodiment of the present invention is generally shown. As will be seen, the apparatus comprises a spring-loaded diaphragm assembly 12 , an inlet chamber 14 , a flow restrictor conduit 16 , a pressure dial 18 , a rate dial 20 , a modulator housing 22 and modulator base 24 . The apparatus of the preferred embodiment is fabricated almost completely of injection molded plastic. [0110] Diaphragm assembly 12 consists of a center diaphragm plate 26 which is captured circumferentially by diaphragm ring 27 . Diaphragm assembly 12 is normally biased in a close position wherein the diaphragm plate 26 rests against the interior end 28 of inlet chamber 14 . A spring 30 is located around a spring boss 32 which maintains spring 30 in a substantially perpendicular orientation relative to diaphragm plate 26 . External threads 34 on pressure-dial 18 engage internal threads 36 within the pressure dial boss 38 , which is located atop modulator housing 22 . Rotating pressure dial 18 causes pressure dial 18 to move longitudinally relative to diaphragm plate 26 , thereby increasing the compressive force on spring 30 as pressure dial 18 is moved closer to diaphragm plate 26 . Pressure dial 18 therefore allows adjustment of the compressive force of spring 30 against diaphragm assembly 12 . Diaphragm plate 26 moves longitudinally within a cylindrical sleeve 40 located within assembly of modulator housing 22 and is in flow connection with a primary modulator chamber 42 formed by the assembly of modulator housing 22 and modulator base 24 . Diaphragm ring 27 can be made of a variety of rubber like compounds but is usually made of silicone plastic or more preferably santoprene, and is pleated so that longitudinal movement of diaphragm plate 26 is minimally restricted. The outer diameter of diaphragm ring 27 is so sized that when inserted into cylindrical sleeve 40 during assembly an airtight seal is formed. Although the outer diameter of diaphragm ring 27 and cylindrical sleeve 40 have been described as round and cylindrical, those skilled in the art can see that other profile shapes are possible without departing from the nature and essence of the invention. [0111] Flow restrictor port 16 is located within modulator housing 22 and is in flow connection with primary modulator chamber 42 . Rate dial 20 allows for adjustment of the rate of gas escaping from modulator chamber 42 to the atmosphere, and adjusting rate dial 20 allows control of a patient's exhalation duration and PEEP. An annular flow restrictor valve seat 52 is located within flow restrictor port 16 . Flow restrictor valve seat 52 functions in conjunction with tapered inner end 55 of rate dial 20 to restrict gas from passing through flow restrictor port 16 . Slots 54 in rate dial 20 have a much larger cross-sectional area than flow restrictor port 16 at its largest setting and poses little restriction to flow. The restricting area between flow restrictor valve seat 52 and the tapered inner end 55 of rate dial 20 is adjustable by positioning rate dial 20 axially through use of external threads 56 on rate dial 20 which engage internal threads 58 within the rate dial boss 60 , whereby rotating rate dial 20 causes tapered inner end 55 to move longitudinally relative to flow restrictor valve seat 52 . Flow restrictor valve seat 52 and tapered inner end 55 at the inner end of rate dial 20 functions similar to a needle valve to create a restrictive annular region to restrict the flow of gas there through. Slots 54 remain of constant cross-sectional area throughout the adjustment range of rate dial 20 . Use of tapered inner end 55 and annular valve seat 52 provides for a sensitive adjustment of gas flow resistance. Although the preferred embodiment discloses using a tapered inner end 55 of rate dial 20 with slots 54 therein along with flow restrictor valve seat 52 to restrict gas flow there through, those skilled in the art would recognize that other means for providing adjustable gas flow resistance exist. As an additional safety feature and protection for the patient against the possibility of the rate dial exhaust port 50 becoming occluded, and thereby exposing the patient to dangerous levels of pressure, an additional safety discharge orifice 48 may be placed in the modulator body allowing a secondary escape of gas from the primary modulator chamber 22 . Said safety discharge orifice 48 may be place anywhere in the modulator body provided it creates the means for fluid communication between primary modulator chamber 22 and the ambient environment. The safety discharge orifice 48 is so sized to not provide so great a discharge of gas as to prevent the adjustment of the PMA to needed exhalation times of up to 5 seconds or more, but is large enough so provide a relief of gas in the event that the rate dial exhaust port 50 is occluded. In practice, safety discharge orifice 48 is approximately 0.125″ in diameter. [0112] During the patient inspiration, diaphragm plate 26 rests against interior end 28 of inlet chamber 14 . This constitutes diaphragm assembly, consisting of diaphragm plate 26 and diaphragm ring 27 , being in a closed position. A sealing ring 62 circumscribing interior end 28 of inlet chamber 14 provides an airtight seal when diaphragm plate 26 rests against interior end 28 of inlet chamber 14 . While diaphragm plate 26 is resting against interior end 28 of inlet chamber 14 , the force of the patient's pressure on diaphragm plate 26 is equal to the product of the patient's pressure and the area circumscribed by sealing ring 62 . As the patient inhalation develops and the patient is charged, the patient's pressure will increase until the force of the patient's airway pressure on diaphragm plate 26 overcomes the compressive force of spring 30 , which causes diaphragm assembly to open (i.e. diaphragm plate 26 moves away from interior end 28 of inlet chamber 14 ). [0113] Diaphragm plate 26 includes equalization conduit 44 that provides the intended fluid path between primary modulator chamber 42 and secondary modulator chamber 46 . Equalization conduit 44 works optimally for the described embodiment if in the diameter range of 0.030″ to 0.050″, but has been shown to continue to perform for diameters as small as 0.010″ and as large as 0.125″. Larger sizes may also be possible, but can be less desirable because bigger sizes begin to limit the PMA to smaller exhalation times than may be desired by the clinician. Although equalization conduit 44 is described herein as round, the actual shape is irrelevant provided that the equivalent cross sectional area is made available for the flow of gas between primary modulator chamber 42 and secondary modulator chamber 46 . Furthermore, multiple orifices, or multiple other cross sectional flow shapes can be utilized if desired without departing from what is described, and equivalent performance would be expected provided that the sum of the cross-sectional flow areas is equal to the cross-sectional area of a single equalization conduit 44 . [0114] Secondary modulator chamber 46 is the enclosed spaced encompassed by the modulator housing 22 , pressure dial 18 , diaphragm plate 26 , and diaphragm ring 27 . An intrinsic property of secondary modulator chamber 46 is that internal pressure within secondary modulator chamber 46 creates a force on the sealing member of the modulator (in this embodiment diaphragm plate 26 ) that is in the same direction as the biasing force (in this embodiment spring 30 ) on the sealing member of the modulator towards the closed position, and which is also in opposition to the resulting force on the sealing member of the modulator as a result of the internal pressure in primary modulator chamber 42 . [0115] Referring to FIG. 3 ambient actuation conduit 64 is shown in pressure dial 18 . Ambient actuation conduit 64 provides fluid communication between secondary modulator chamber 46 and the ambient environment. When ambient actuation conduit 64 is un-occluded pressure modulator apparatus 10 provides ventilatory support as previously described, and as is normal for other PMAs. In the event that the clinician places his or her finger over the pressure dial, this will cause the occlusion of ambient actuation conduit 64 . When ambient actuation conduit 64 becomes occluded the pressure in secondary modulator chamber 46 is allowed to rise, thus providing additional force on diaphragm plate 26 in the same direction of the biasing force of spring 30 , and thus the pulmonary modulator apparatus 10 closes. Upon the pulmonary modulator apparatus 10 closing, the patient will begin to be charged with gas and the patient's airway pressure will rise until such time that the force of the patient's pressure on diaphragm plate 26 , circumscribed by the sealing ring 62 , overcomes the force of spring 30 . While ambient actuation conduit 64 is occluded, the pressure differential between primary modulator chamber 42 and secondary modulator chamber 46 are minimized through the fluid communication provided by equalization conduit 44 . So long as this is the case, pulmonary modulator apparatus 10 can not behave as a dual area valve that opens at one pressure and closes at another lower pressure, thus cyclical ventilatory support is not provided by pulmonary modulator apparatus 10 , and, upon the patient's airway pressure reaching sufficient value to overcome spring 30 , the diaphragm plate 26 will move away from sealing ring 62 of just sufficient distance for the patient's airway pressure to be maintained at a constant value approximately equal to the patient pressure sufficient to overcome spring 30 . The ambient actuation conduit 64 need not necessarily be in the pressure dial, and may be placed anywhere provided that it allow fluid communication between secondary modulator chamber 46 and the ambient environment and have some means of being occluded, either directly by the clinician's finger, or by some other mechanical means or apparatus. The current embodiment uses a circular cross-sectional shaped ambient actuation conduit 64 that is approximately 2.5 times greater in diameter than equalization conduit 44 , but a wide range of sizes would be sufficient and work equally as well as what is described herein provided that they are larger in cross sectional area than equalization conduit 44 and that they may in some manner or form be occluded by the clinician. As with equalization conduit 44 , the exact shape and number of conduits used to form ambient actuation conduit 64 are not as important as the total combined cross-sectional area and the means to be occluded by the clinician. Of additional importance is that external threads 34 and internal threads 36 be of sufficient fit to prevent undue leaking of gas from secondary modulator chamber 46 into the ambient environment thus having a detrimental effect on the operation of ambient actuation conduit 64 . [0116] Referring again to FIG. 4 pressure modulator apparatus 10 and a patient adapter 66 are shown combined together to function as an automatic resuscitator or ventilator. Patient adapter 66 is attached to inlet chamber 14 of pressure pulmonary modulator apparatus 10 via attachment port 68 . Patient adapter 66 is equipped with a pop-off valve 70 , a patient demand valve 72 , a gas inlet port 74 and a patient connection port 76 . The combination of pressure modulator apparatus 10 and patient adapter 66 serves as a automatic resuscitator or ventilator which may be interface with a face mask 80 , as shown in phantom, or an endotracheal tube. [0117] Gas inlet port 74 allows connection to a source of compressed gas (not shown), such as compressed air or oxygen. The compressed gas source is attached to gas inlet port 74 using a DISS connector, barb, or snap connection (not shown). Internal to gas inlet 74 is an orifice sized to ensure that for an approximate 50 psig compressed gas source, the flow will not exceed approximately 40 liters/minute. Typically, the compressed gas would consist entirely of 100% compressed oxygen but a clinician may use any type of compressed gas as deemed appropriate. The compressed air or oxygen is delivered directly to the patient for inhalation. Gas inlet port 74 can also be so configured that the exiting jet emitting from the sized orifice entrains room air through ports positioned adjacent to said orifice, thus 15 l/min of oxygen may result in delivery of an air oxygen mixture to the patient at a combined rate of 40 l/min. [0118] Patient demand valve 72 is a one-way valve, comprising of a flapper 80 placed between a one-way valve port 82 and a valve body 84 , which allows air to be entrained from the room environment. Patient demand valve 72 allows the patient to draw in more air than that which is being continuously supplied to patient adapter 66 through gas inlet port 74 from the compressed gas source, thus giving the patient not only the means to initiate the beginning of inhalation but also the duration. In the preferred embodiment, patient demand valve 72 has a very low resistance to flow, which is on the order of approximately 3.5 cm H 2 O at 50 liters/minute. [0119] Pop-off valve 70 provides a safety feature to prevent the patient airway pressure from exceeding any set, or pre-set, value and consists of pop-off spring 88 , pop-off piston 90 , and pop-off housing 92 . Pop-off piston 90 is biased by pop-off spring 88 and equipped with a sealing edge 94 . Pop-off valve 70 opens anytime the patient's airway pressure exceeds a preset value whereby the force of the patient's pressure on pop-off piston 70 overcomes the bias and restorative force of pop-off spring 88 . Pop-off valve 70 can be equipped with a means to create an audible tone and a visual signal when the valve 70 is opened. Although Pop-off valve 70 provides a needed back up pressure relief, it is set at a high enough value that pressure reached to cause it to open may still be dangerous to some patients. Another embodiment of the invention, and one that will result in less parts, is to combine patient demand valve 72 into pop-off valve 70 . Such an embodiment includes equipping pop-off piston 90 with fluid conduits and a flapper that preferentially allow flow into, but not out of, patient adapter 66 . [0120] Patient connection port 76 allows a connection of a breathing mask 86 , an endotracheal tube (not shown), or a laryngeal mask airway (also not shown) which the patient wears during the breathing process associated with resuscitator 78 . Because the pulmonary modulator apparatus 10 is closed during inhalation, all incoming gas is delivered to the patient through patient connection port 76 . In the preferred embodiment, patient connection port 76 has a 22 mm OD for connection to PEEP masks (not shown) and a 15 mm ID for connection to endotracheal tubes. [0121] When inhalation pressure reaches that which is dialed on pressure dial 18 , diaphragm plate 26 moves to the fully open position, the patients peak pressure (PIP) to the patients baseline pressure (PEEP) is 10:1, which is consistent with the ratio of the full surface area of diaphragm assembly in pulmonary modulator apparatus 10 and the surface area circumscribed by sealing ring 62 . Pressure dial 18 and pulmonary modulator spring 30 are designed so that the resuscitator delivers a maximum patient peak pressure (PIP) of approximately 55 cm H 2 O and a minimum PIP of approximately 10 cm H 2 O, although these pressures and the referred ratio are not the physical limit of the apparatus. Pop-off valve 70 is designed to relieve pressure if the patient's airway pressure rises above approximately 60 cm H 2 O. [0122] Thereby the present invention provides the means for a user to initiate inhalation immediately without changing any baseline settings of the device whenever the invention stops providing ventilatory support (i.e. stalls) regardless if the device stopped cycling due to changes in physiological, mechanical, pneumatic or environmental conditions, by simply occluding ambient actuation conduit 64 . Thereby the present invention is capable of being used by a user to determine the sedative state of a patient by adjusting the device to the spontaneous mode and satisfying oneself that the device only initiates inhalation when ambient actuation conduit 64 is occluded. Thereby the present invention is capable of higher PEEP settings than are otherwise possible by increasing the rate dial setting such that the restriction to flow and the continuous flow of gas provides the desired PEEP pressure, causing the device to be in a spontaneous mode, whereby the user causes cycling of the device by periodically occluding ambient actuation conduit 64 . Thereby the present invention is capable of providing an inspiratory hold by the user occluding and holding ambient actuation conduit 64 for the desired time. Thereby the present invention provides a reliable and simple alternative ventilatory support mode requiring less sophistication by the user and which is realized by the user simply occluding ambient actuation conduit 64 periodically whenever inhalation is desired, and releasing ambient actuation conduit 64 whenever exhalation is desired. [0123] Referring to FIG. 6A and FIG. 6B is shown an alternative embodiment to pulmonary modulator apparatus 10 . Instead of a diaphragm assembly using diaphragm plate 26 and diaphragm ring 27 , the referenced alternative embodiment uses a piston assembly consisting of piston ring 94 and a piston seal 96 which is preferably made of a polyethylene or like material, and piston base 98 . Piston seal 96 is placed over piston base 98 and is held in place by piston, ring 94 that is placed over piston seal 96 and caused to be snapped and held into place in reference to piston base 98 . An equalization conduit is caused by aligning during assembly piston ring orifice 100 , piston seal orifice 102 , and piston base orifice 104 such that fluid communication is possible between the primary and secondary modulator chambers of the shown alternative embodiment. Alternative second pressure dial 106 is not equipped with fluid communication means that allow flow communication between the secondary modulator chamber and the ambient environment, instead means are provided by the alternative placement of ambient actuation conduit 108 that is placed in the modulator body as shown, and which functions identically as described in the first and preferred embodiment. With the exception of the inventive concepts described herein, further details of this embodiment are already known in the art and reference is made to U.S. Pat. No. 6,067,984. [0124] Referring to FIG. 7 is shown an alternative embodiment to pulmonary modulator apparatus 10 . Third pulmonary modulator apparatus 110 consists of a long diaphragm 112 , outer spring 114 , sealing o-ring 116 , equalization conduit 118 , ambient actuation conduit 120 , third pressure dial 122 , third inlet chamber 124 , third modulator body 126 , primary modulator chamber 128 , and secondary modulator chamber 130 . With the exception of the inventive concepts described herein, further details of this embodiment are already known in the art and reference is made to U.S. Pat. No. 6,067,984. [0125] Although the description above contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Thus the scope of this invention should be determined by the appended claims and their legal equivalents.

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BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a hair styling product. More particularly, the present invention relates to a hair straightener or straightening device that uses hot air to straighten or smooth the hair. [0003] 2. Description of the Prior Art [0004] A variety of different devices and methods may be used for straightening hair. For example, the user may employ a hairbrush to place tension on his or her hair while applying heated air with a hair dryer. In particular, the user gathers a portion of hair and extends it away from the user's head. The extended hair portion is then treated with heated air to enable it to retain its extended shape. However, this method is a two-handed procedure that requires agility, concentration and, thus, can be strenuous and tiresome for the user. [0005] An alternative method for hair straightening is use of a styler/dryer appliance. The appliance has various styling attachments, such as a brush or a comb, which attach to the nozzle of the hair dryer, and typically having an elongated body with a head portion in which the hot air flow exits laterally therefrom. Thus, the appliance can be manipulated in the same fashion as a common brush, namely one's hair being dried and styled as the user merely brushes or combs his or her hair. The air outlet in a styler/dryer is a larger area than that of the typical blower/dryer and, consequently, the air exits through this outlet at a lower velocity. This lower velocity and less concentrated air flow will not tend to adversely blow or scatter the user's hair as much as the high velocity air in the blower/dryer, thereby facilitating the styling operation. U.S. Pat. No. 5,842,286 discloses an example of such a styler/dryer. [0006] Hair can also be straightened by applying a relaxing agent to break down the natural curls of the hair. A hair dryer is then typically used to dry the hair and, in some cases, provides the requisite heat necessary to activate the relaxing agent. [0007] Further, a curling iron or similar device may facilitate straightening of hair by compressing the hair between flat surfaces of heated iron. SUMMARY OF THE INVENTION [0008] It is an object of the present invention to provide a device for straightening hair. [0009] It is another object of the present invention to provide a hair straightener that straightens the user's hair by using hot air. [0010] It is still another object of the present invention to provide a hair straightener in which a various attachments can be readily attached and detached from the body or handle of the device. [0011] These and other objects and advantages of the present invention are achieved by the hair straightener of the present invention. The hair straightener comprises a handle having a heat generator and a convector to direct heat away from the handle, a housing connected to the handle and having a heatable surface with one or more vents to release the heat from the housing, a guide for directing hair onto the housing, and a heat distributor adjacent the housing to direct heat from the handle through the vents. The heat generated from the heat generator is directed by the convector into the housing. The heat distributor moves the heat through the housing, thereby heating the heatable surface of the housing and directing heat out of the vents to facilitate the straightening of hair secured by the guide. [0012] The present invention also provides an attachment for a hair care device. The attachment comprises: a housing having a heatable surface with vents to release the heat from the housing, a guide for directing hair onto the housing, and a cone-shaped heat distributor in the housing to direct heat from the handle through the vents. The cone-shaped heat distributor also directs heat through the housing, thereby heating the heatable surface of the housing and directing heat out of the vents to facilitate the straightening of hair secured by the guide. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The foregoing and still further objects and advantages of the present invention will be more apparent from the following detailed explanation of the preferred embodiments of the invention in connection with the accompanying drawings: [0014] [0014]FIG. 1 is a top view of the hair straightener of the present invention; [0015] [0015]FIG. 2 is a side view of the hair straightener of FIG. 1; [0016] [0016]FIG. 3 is a side view of a portion the hair straightener of FIG. 1, turned ninety degrees; [0017] [0017]FIG. 4 is an opposite side view of the portion of the hair straightener of FIG. 3; [0018] [0018]FIG. 5 is an end view of the portion of the hair straightener of FIG. 3; [0019] [0019]FIG. 6 is an exploded view of the components of the hair straightener of FIG. 1; and [0020] [0020]FIG. 7 is a schematic diagram showing the path of the airflow through the hair straightener of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION [0021] Referring to the figures and, in particular, FIGS. 1 and 2, a hair straightener or straightening device of the present invention is generally represented by reference numeral 10 . Hair straightener 10 has a body that includes a housing 50 and a handle 70 adapted to be connected to the housing via an adapter 20 . Preferably, housing 50 and handle 70 are in axial alignment. [0022] Referring to FIGS. 1 and 2, handle 70 has a lower handle 72 and an upper handle 74 that are adapted to be removably connected together. They can be secured together by conventional means, such as, for example, one or more screws or mating surfaces, one of which is female and the other of which is male that are adapted to snap fit to each other. Handle 70 also has a switch (not shown) and switch cover 76 , preferably in upper handle 74 , that is adapted to activate a power source. The switch cover 76 is secured to handle 70 , such as, for example, one or more screws 78 . At the end 71 of handle 70 , opposite body 50 is a cap or end cap 80 . End cap 80 is preferably removable. Between end 71 and cap 80 , there can be positioned a filter 82 . It is noted that the portion of handle 70 that encloses filter 82 has a plurality of holes or apertures 81 to permit the filter to breathe. [0023] Preferably, cap 80 is the connection from handle 70 to a power source, such as, for example, an AC power source. [0024] Both lower handle 72 and upper handle 74 are made of an appropriate material, such as plastic, metal, rubber or wood. Preferably, the material is plastic. [0025] Referring to FIG. 3, housing 50 has a heatable surface or heat transmissive plate 56 with one or more vents 58 that permit the release of the heat from the housing. Housing 50 is adapted to receive a covering 60 about its outer exterior. Preferably, covering 60 is a two-piece structure that surrounds heat transmissive plate 56 . Covering 60 has two or more, and preferably a series (which is at least three) of rings 61 , and two or more, and preferably a series of, guides or teeth or series of tines 62 . The series of rings 61 , are preferably curved, and surround the exterior of housing 50 . The teeth or series of tines 62 protrude from housing 50 to evenly distribute hair. The covering 60 is held together at the top by a tip 52 and at the bottom by adapter 20 . Adapter 20 operatively connects and secures housing 50 and covering 60 to handle 70 and allows for the transmission of air from the handle to the housing. Further, adapter 20 prevents any rotation or movement of covering 60 , thereby allowing for hair to be securely guided for straightening. [0026] Heat transmissive plate 56 is preferably made of a material that is capable of absorbing heat from the hot air produced by the fan located in handle 70 and transmitting the absorbed heat to the user's hair. Such a material is metal, such as aluminum, or a heat conducting polymer, such as a talc-filled nylon, or a metal filled polycarbonate. Preferably, covering 60 is made of plastic. The rings 61 and teeth 62 may be made of plastic, rubber, or any mixtures thereof. However, the curved rings 61 and teeth 62 may also be integral to covering 60 as shown in the figures. [0027] Referring to FIG. 7, housing 50 is preferably cylindrical. Housing 50 has an air restrictor or air baffle 66 that is connected to a heat distributor or air diverter 64 . Preferably, the connection is removable. Baffle 66 is preferably located in the center of housing 50 . Heat transmissive plate 56 surrounds the air baffle 66 and air diverter 64 . The one or more vents 58 of heat transmissive plate 56 direct the heated air. The heat distributor or diverter 64 in housing 50 directs heat from handle 70 through the one or more vents 58 . Preferably, diverter 64 is cone-shaped to facilitate the direction of heat. In a preferred embodiment, the tip of the cone-shape of diverter 64 is directed to handle 70 . [0028] As shown in FIG. 6, heat transmissive plate 56 is preferably laterally curved so that the hair may glide over its upper surface. Also, heat transmissive plate 56 is situated underneath covering 60 such that curved rings 61 surround heat transmissive plate 56 . The rings 61 are designed so that neither the user's scalp nor neck, come into contact with heat transmissive plate 56 . The rings 61 help to separate and guide the user's hair. The plurality of teeth 62 of covering 60 weave through the user's hair and pull the hair to create tension so that the hair is drawn evenly and tightly across heat transmissive plate 56 . Thus, the tension of pulling the user's hair straightens the hair, and the action of drawing the hair across heat transmissive plate 56 causes the hair to be straightened. [0029] As stated above, the heat generated from a heating coil or other type of heat generator (not shown), in handle 70 , is directed by a fan or other type of convector (not shown), also in handle 70 , into housing 50 , and diverter 64 moves the heat through the housing, thereby heating transmissive plate 56 and directing heat out of the one or more vents 58 to facilitate the straightening of the hair secured by the guide. [0030] Housing 50 is preferably connected to handle 70 by adapter 20 , which is preferably configured to releasably receive and secure both housing 50 and handle 70 . Adapter 20 also preferably is configured to enable housing 50 to be releasably connected to various different hair care devices. However, any other method of connection which allows for the transferability of housing 50 to other hair care devices may also be used. Thus, housing 50 can be readily attached and detached from handle 70 , and readily attached onto another hair care device such as, for example, a hair dryer. [0031] [0031]FIG. 6 also shows adapter 20 and housing 50 with components thereof that make up and connect the housing to handle 70 . These components include cap 52 , air baffle 66 , air diverter 64 , heat transmissive plate 56 with vents 58 , and covering 60 with rings 61 and teeth 62 . Air baffle 66 preferably has a plurality of openings and functions to restrict the flow of air from handle 70 to housing 50 and to distribute the airflow evenly through and between each vent 58 in housing 50 . Air diverter 64 , as described above, facilitates the transfer of heated air from housing 50 to heat transmissive plate 56 and vents 58 . FIG. 7 illustrates the air flow pattern through housing 50 . [0032] An additional feature of the present invention is a “cool shot button” that allows for momentary removal of heat from device 10 yet continues the flow of air to cool and set hair after straightening. This is preferably accomplished by the arrangement of the heat generator with the convector. Preferably, a portion of the heat generator serves as a voltage dropping, series resistor for the convector. Thus, preferably when the “cool shot button” is actuated, the heat generator is switched off and the portion of the heat generator that is in series with the convector remains open. This allow for the convector to continue to operate and generate an airflow while the heat generator ceases to produce heat thereby creating cool shot of air. [0033] It should be understood that the foregoing description is only illustrative of the invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances.

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