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BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to instrumentation used in the areas of inhalation therapy, respiratory therapy or respiratory diagnostic procedures in the field of medicine. More particularly, the invention concerns a patient mouthpiece device incorporating a protective covering, or enclosure, for encapsulating the patient mouthpiece section both before and after use to prevent spread of contamination. 2. Discussion of the Prior Art Inhalation therapy and respiratory diagnostic procedures as they relate to patient care have been well documented and have been accepted standard practices in hospitals, extended care facilities, and even private homes for many years. Daily, numerous patient procedures are routinely practiced in such facilities which require that the patient breathe from, through or into some special respiratory system or equipment. In most instances, the interface between patient and instrumentation involves a patient mouthpiece and a length of flexible corrugated tubing. Characteristically, as the patient breathes back and forth through the mouthpiece and tubing, varying amounts of saliva become entrapped in the mouthpiece and corrugated tubing. Upon removal of the mouthpiece from the patient, the saliva immediately becomes a source of cross-contamination for anything or anyone that might come in contact with it. Often substantial amounts of saliva are present in the mouthpiece and its associated tubing and will leak out unless the technologist takes extra precaution and wraps the mouthpiece in some type of absorbent material. This situation creates not only an unsanitary condition for the technologist, but also creates extremely hazardous possibilities of contamination spread. Where the procedure involves radioactive materials, the hazardous spread of radiation contamination is also quite possible. Another source of cross-contamination in respiratory areas results from the procedure for attaching the new mouthpiece to the associated instrumentation. Typically, the mouthpiece is removed from its container by the technologist and one end thereof is inserted into either a length of breathing tubing or into a bacterial filter. Commercially produced prior art patient mouthpieces are generally no more than two and one-half inches in length, and approximately one-third of this length must be pushed into the cooperating tubing or filter. In so doing, it is almost impossible for the technologist to properly attach the mouthpiece without handling and severely risking contaminating the mouthinsertion end of the device. As will be appreciated from the discussion which follows, the present invention for the first time addresses and uniquely solves the problems set forth in the preceding paragraphs. SUMMARY OF THE INVENTION It is an object of the present invention to provide a patient mouthpiece apparatus which incorporates a cover or shield, that, when fitted over and around the patient mouthpiece will entrap any saliva contained therein and will effectively prevent external leakage of possibly highly contaminated saliva. Another object of the invention is to provide a device of the aforementioned character which will also serve as a cover to protect the mouthpiece from handling and possible contamination by the technologist prior to patient use and during interconnection with the mouthpiece with the associated supply tubing or equipment. A further object of the invention is to provide a patient mouthpiece apparatus which incorporates a fitted removable protective shield that will fully encapsulate that area of the mouthpiece which has been in contact with the patient's mouth to prevent technologist contact with the contaminated area. Yet another object of the invention is to provide a patient mouthpiece apparatus which incorporates a fitted removable protective shield of the character described that can be quickly and easily attached to the patient mouthpiece without the operator having to touch any contaminated area. Still another object of the invention is to provide a patient mouthpiece apparatus incorporating a fitted removable protective shield as herein described which is simple in design, easy to use and inexpensive to manufacture in large volume. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded, generally perspective view of the patient mouthpiece apparatus of one form of the invention. FIG. 2 is an exploded, side elevational view of the apparatus partly broken away to show internal construction. FIG. 3 is a side elevational, cross-sectional view of the apparatus showing the protective cover in position over the mouthpiece portion of the device. FIG. 4 is a top, cross-sectional view taken along lines 4--4 of FIG. 3. FIG. 5 is a cross-sectional view taken along lines 5--5 of FIG. 3. DESCRIPTION OF THE INVENTION Referring to the drawings and particularly to FIGS. 1, 2 and 3, the patient mouthpiece apparatus of the form of the invention there illustrated is generally designated by the numeral 12. This embodiment apparatus of the invention is adapted for use in connection with respiratory equipment for supplying fluids such as liquids and gases to a patient through a conduit which interconnects the remotely located respiratory equipment with the mouthpiece portion of the apparatus. As best seen by referring to FIG. 1, the apparatus comprises a first, or mouthpiece portion, 14 and a second, or mouthpiece encapsulation, portion 16. The mouthpiece portion includes a generally tubular shaped body 18 having an elliptical shaped fluid passageway 20 therethrough. Body 18 has first and second ends generally designated as 22 and 24. Second end 24 is adapted to be interconnected with the remotely located respiratory equipment and connector means are provided for that purpose. In the present embodiment of the invention, the connector means comprises a pair of longitudinally spaced, radially outwardly extending ribs 28 which circumscribe body 18. When the conduit which interconnects the mouthpiece with the remotely located respiratory equipment comprises a yieldably deformable plastic tube the open end of the plastic tube is closely receivable over and held in place by ribs 28. The conduit may also comprise a filter unit in which case the inlet of the filter unit is receivable over and held in place by ribs 28. Disposed within the central portion of body 18 is an internal saliva entrapment cavity generally designated by the numeral 30. Referring particularly to FIGS. 1 and 3, it is to be noted that a first generally planar wall 32 circumscribes body 18 at a location intermediate the first and second ends thereof. Planar wall 32 is generally elliptical in shape and, as will presently be described, is closely receivable within the open end of the skirt portion of the encapsulating means of this form of the invention. A second, generally elliptically shaped curved wall 34 is located proximate the first end of body 18. Wall 34 is specially configured to be comfortably received within the patient's mouth. The novel shape of wall 34 uniquely permits the mouthpiece portion 14 to be held comfortably and securely in place within the patient's mouth during the introduction of fluids from the remotely located respiratory equipment. While various other configurations of wall 34 can be used, the generally elliptical shape shown in FIG. 1 of the drawings has proven to be quite successful in clinical tests. The second, or mouthpiece encapsulation, portion, of the apparatus comprises a hollow skirt portion 38 which is closely receivable over walls 32 and 34 of mouthpiece portion 14. As best seen by referring to FIG. 3, skirt portion 38 has a first end 38a which is sealably closed by an integrally formed end closure wall 40. The open end 38b of the skirt 38 is configured so as to closely and sealably receive wall 32 of the mouthpiece portion in the manner shown in FIGS. 3 and 4. In FIG. 5, the cross-section of the skirt portion is elliptical shaped. In this regard, it is to be noted that skirt portion 38 tapers slightly outwardly from wall 40 so that as the mouthpiece portion 14 is inserted into the encapsulation portion, wall 32 will tightly engage the internal wall of skirt 38 at a location slightly inboard of the open end 38b. With this construction, the mouthpiece portion 14 will be secureably sealed within, and encapsulated by, the encapsulation portion 16. Another important feature of the apparatus of the invention comprises the sealing means of the device for sealably closing the fluid passageway 20 of body 18. In the present embodiment of the invention the sealing means comprises an inwardly tapering closure member 42 which has a cross-section that is elliptical shape end is integrally formed with, and extends inwardly of, wall 40 in the manner shown in FIGS. 3, 4, and 5. Closure member 42 is closely receivable within passageway 20 of body 18 and, due to its inwardly tapering configuration, will sealably engage the inner wall 20a of passageway 20 so as to positively seal off the saliva entrapment chamber 30 and effectively prevent any leakage of saliva from the device. The apparatus of the invention can be constructed of a variety of materials. However, in practice both the first and second portions of the device are integrally formed of a moldable plastic material such as polyethylene or polypropylene. In using the apparatus of the present invention to safely seal off a possibly contaminated mouthpiece relative to atmosphere, encapsulating portion 16 is placed over mouthpiece portion 14 while portion 14 is still connected to the respiratory equipment. Because the patient has breathed inwardly and outwardly through the mouthpiece, varying amounts of saliva have become entrapped in the cavity portion 30 and within the passageway 20 of the mouthpiece portion. As the encapsulating portion is placed over and urged into engagement with the mouthpiece portion, the sealing means or closure member 42 will be closely received within passageway 20 so as to sealably close the passageway and isolate the saliva entrapment chamber from atmosphere. At the same time that the closure member 42 is being forced into sealing engagement with the inner wall of passageway 20, closure wall 32 of the mouthpiece is being moved into sealable engagement with the inner wall of the skirt portion 38. The fit of the closure member 42 to passageway 20 and of wall 32 to skirt 38 is such that frictional forces will securely hold together the first and second portion of the apparatus. In this matted position, the interior of the mouthpiece containing the patient's saliva is effectively sealed relative to atmosphere. Further, since the encapsulating means of the apparatus completely encapsulates that portion of the mouthpiece section which has been in the patient's mouth, spread of contamination from the surfaces which have been in contact with the patient's mouth is also effectively prevented. Another important aspect of the apparatus of the present invention resides in its pretreatment during interconnection of the mouthpiece portion with the auxiliary respiratory equipment, such as a piece of breathing tube, bacterial filter or the like. So long as the protective shield or encapsulating portion is in position around the mouthpiece section, the apparatus can be safely handled by the technologist without fear of contaminating the mouthpiece. More particularly, end 24 of the mouthpiece can be interconnected with the conduit or bacterial filter, which forms a part of the remotely located respiratory equipment, without fear of contamination of those surfaces of the mouthpiece which are to be received within the patient's mouth. This unique feature of the apparatus effectively prevents the spread of contamination from the technologist to the patient. 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.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This Application claims the benefit of U.S. Provisional application No. 61/319,104 filed on Mar. 30, 2010, the entirety of which is hereby incorporated by reference. BACKGROUND [0002] Patient monitoring systems for sensing, monitoring and displaying the blood oxygen saturation level (rSO 2 ) of a region of a patient are known, including the commercially-available INVOS® system from Somanetics Corporation in Troy, Mich., now owned by Covidien, headquartered in Mansfield, Mass. Such systems commonly include a sensor configured to be temporarily affixed to a patient and in communication with a processor, which is configured to receive signals from the sensor and calculate an rSO 2 value. The systems commonly calculate an rSO 2 of a monitored region of the patient on a periodic basis, for example, every five seconds. Conventionally, the most current “real time” rSO 2 value and a historical graph of some number of prior real time rSO 2 values may be displayed on a computer monitor so that a caregiver could read and assess the rSO 2 data. [0003] It has been observed by the inventors, though, that displaying the real time rSO 2 value and historical rSO 2 values alone may not be optimal for a caregiver to properly assess the impact of blood oxygen saturation on the patient, particularly (though not exclusively) in neonates. Some patients, especially neonates, exhibit large variations in tissue oxygen (O 2 ) delivery, which can be dependent on gestational age, day of life, and on the tissue or organ monitored. As a result, a progressive change in the rSO 2 value, which may be indicative of an impending biological catastrophe, may be obscured by the high variability of the real-time rSO 2 values. [0004] Accordingly, the inventors hereof have identified a need for an improved patient monitoring and display system for rSO 2 levels that calculates and displays additional data to improve the information available to a caregiver assessing the blood oxygen saturation condition of a patient. SUMMARY [0005] An improved patient monitoring system for monitoring rSO 2 of a patient is disclosed. The improved system displays historical and current real time rSO 2 values for the patient. Additionally, the system calculates and displays statistical trending data, such as a trailing statistical average, of the real time rSO 2 . The combined display of real time rSO 2 values and statistical trend data of the rSO 2 values better enables a caregiver to assess a patient's blood oxygen saturation condition, including predicting impending biological catastrophes, particularly in patients (such as neonates) who have high variability in O 2 delivery. BRIEF DESCRIPTION OF THE FIGURES [0006] FIG. 1 is an illustrative example of a system according to an embodiment, as used in one exemplary environment to perform spectrophotometric cerebral oximetry. [0007] FIG. 2 illustrates an exemplary screenshot of the display of the patient monitoring system configured to display real time blood oxygen saturation information and a statistical trend value, both on a plotted line graph over time. DETAILED DESCRIPTION [0008] FIG. 1 illustrates an exemplary environment for implementation of a system 10 for monitoring rSO 2 of a patient. The system 10 has a spectrophotometric apparatus 18 connected to a sensor 16 through an electrical cable 24 . The electrical cable 24 may include a signal amplifier 26 . The spectrophotometric apparatus 18 is a computer or other processor-based computing device 20 and a monitor or other visual display device 22 . The computing device 20 includes customary memory devices that store data and algorithm instructions and a processor that executes algorithm instructions. The sensor 16 takes spectrophotometric readings of the monitored region and generates corresponding representative electrical signals, which are conveyed to the computing device 20 . The computing device 20 processes the signals and causes data to be displayed on the monitor 22 . [0009] Periodically, the computing device 20 calculates an rSO 2 value from the electrical signals. The calculated real time rSO 2 value is numerically displayed on the monitor 22 . Additionally, a certain number of historical real time rSO 2 values are graphically plotted to generate a line graph of the historical real time rSO 2 values over time. From these two displays, a caregiver can observe the current rSO 2 level of the patient, as well as the historical rSO 2 levels. [0010] Further, computing device 20 calculates a trend statistic of the real time rSO 2 values. One such trend statistic is a trailing average of the real time rSO 2 values. A person of ordinary skill in the art understands how to calculate a trailing average value from a group of rSO 2 values. In general, an average of all of the non-zero rSO 2 values calculated for a particular period of time, e.g., the last 60 minutes, is calculated each time a new real time rSO 2 value is calculated. Each calculated average value is plotted to generate a line graph of average rSO 2 values over time, which is displayed on the monitor 22 concurrently with the numerical representation of the current real time rSO 2 value and the line graph of the historical real time rSO 2 values. Other known trend statistics may be used instead of a trailing average value, such as a trailing median value, and they may be displayed in various ways other than a line graph. The object is to calculate and display a trend statistic that provides a caregiver with information from which the trend of the real time rSO 2 values can be assessed. [0011] FIG. 2 illustrates an exemplary display on a monitor 22 showing the real time rSO 2 values and the statistical trend data for two different channels. References 100 a and 100 b are directed to the numerical representation of the current real time rSO 2 value for the first and second channels, respectively; lines 104 a and 104 b are the graphical representations of the historical real time rSO 2 values, plotted over time, for the first and second channels, respectively; line 102 a and 102 b are the graphical representations of statistical trend data, e.g., the trailing average values, plotted over time for the first and second channels, respectively. Other configurations and arrangements of the illustrated regions on the monitor 22 are contemplated and within the scope of invention. [0012] The exemplary embodiment described herein has several advantages over known blood oxygen saturation monitoring systems. For example, a trend statistic, such as a trailing average or median, can alert a caregiver to slowly progressive changes that presage impending events, including catastrophic biologic changes. This is counterintuitive since it would seem more appropriate to watch the real time measurements than to look at a trend statistic. However, where the perfusion distribution of the patient, such as a neonate, is highly variable, progressive average change of the data can be obscured by the erratic nature of the real time values. Displaying a trend statistic assists the caregiver in identifying such progressive average changes. On the other hand, it remains useful to display the real time values as well. The real time values allow the caregiver to determine if the trend statistic represents mostly signal dropout coupled with consistently low readings or if it is just the normal wide variation giving the same low average blood oxygen saturation values. [0013] The combined use of real time rSO 2 values and trend statistics is beneficial as illustrated by the following examples. An rSO 2 profile of mostly rSO 2 of 15-20 mmHg with intermittent periods of 35-45 mmHg can evidence a different clinical condition from prolonged periods of mostly 20-25 mmHg with no periods higher. But both could present the same trend statistic (e.g., a trailing average) while the real time data would highlight the difference. Conversely, presenting the data as a rolling average in combination with the real time data is critical so that if there is a sudden catastrophic change it will not be obliterated by the average graph. This is exemplified in a situation where PaCO 2 suddenly drops due to over ventilation causing a dramatic drop in the cerebral blood flow 1 . 1 PaCO 2 is the partial pressure of carbon dioxide in arterial blood, measured by analyzing an arterial blood sample on a blood gas machine. Normal range is 35-45 mmHg and increases in PaCO 2 selectively raise cerebral blood flow by about 2-3% per mmHg and vice versa. [0014] An exemplary application of the above-described embodiment is directed to detecting necrotizing entercolitis (“NEC”) in neonates. NEC in neonates may be predicted by caregivers based on the degree of variability of rSO 2 in the gut of a neonate. [0015] In addition to display of averaged values, an exemplary approach is described where a measure of variance is ascribed to the averaged data epoch. This measure of variance could be the actual statistical variance, the standard deviation, the confidence interval, standard error or some other measure of variability of the data, hereinafter “index of variability.” Variability over short (0-60 seconds) and medium (1-30 minutes) time frames is inherent to physiological systems and can indicate the robustness of those systems. The index of variability can be used to track both short- and medium-term variability depending on the length of the averaging epochs and the method used to calculate the index. Because different areas of the body exhibit differing blood flow rates, the time frames, epoch lengths, and methods used to calculate the variability index can be adjusted based on expected flow in various organs or body areas. This adjustment can be user selectable or can be automatically invoked based on the label assigned to a specific channel indicating its sensor location or typical flow rates. [0016] Variability in certain physiological systems can change based on factors other than the patient's well-being. For example, variations of the hemodynamics of the splanchnic circulation can change significantly during pre- and post-prandial conditions. Likewise, variations in cerebral blood flow can increase significantly if cerebral perfusion pressure falls to a level close to or below the lower limit of autoregulation. Premature infants exhibit very high levels of variability in some organ beds such as the splanchnic bed during the first weeks of life. Therefore, the patient monitor disclosed herein can change the method of calculation, the length of data epochs, or the thresholds used for alerting caregivers based on demographics, gestational age, location of the measurement, feeding status or other measures or parameters to allow the system to adjust to varying conditions and demographics. [0017] The index of variability can be displayed in several unique ways. For example, in one exemplary implementation, dotted lines above and below the trend line of the average value can indicate variance above and below the mean value. The areas above and below the mean may be filled in with a transparent color such that objects below are still visible. Further, a series of whiskers or error bars may be added to the averaged trend to indicate the magnitude of variability above and below the mean. [0018] Changes in the index of variability can be tracked over time to indicate basic changes in the well-being of the patient. As variability decreases, in most cases the overall well-being of the patient is declining. Likewise, as variability increases, well-being is usually improving. Therefore, changes in variability beyond a fixed or user-adjustable threshold can be used to alert caregivers to changes that may reflect changes in patient condition. Additionally, real time values that remain significantly outside the limits of variability for a preset or adjustable time period may also trigger an alert or message to indicate a major change in the patient's condition. Indication of significant changes in the index of variability can be indicated on the trend through color changes, drawing the user's attention to the change as it occurs. Alternately, changes in variability can trigger a message on the screen or can be used to activate an audible alert to warn the user that a change is occurring. [0019] While the index of variability can extract information on significant changes to the magnitude of variations, another implementation can process data in a way that extracts information on the frequency of variations. By observing data in the frequency domain, significant changes in the power and frequency of variability can be observed in real time. The patient monitor described herein is configured to convert epochs of data to the frequency domain using a method such as Fourier transformation where the power of variability is plotted against the frequency of that variation. Using this technique, significant changes in either power or dominant frequency of variations can be tracked and changes greater than a threshold can be used to trigger an alert as described previously. [0020] With regard to the processes, systems, methods, heuristics, etc. described herein, it should be understood that, although the steps of such processes, etc. have been described as occurring according to a certain ordered sequence, such processes could be practiced with the described steps performed in an order other than the order described herein. It further should be understood that certain steps could be performed simultaneously, that other steps could be added, or that certain steps described herein could be omitted. In other words, the descriptions of processes herein are provided for the purpose of illustrating certain embodiments, and should in no way be construed so as to limit the claimed invention. [0021] Accordingly, it is to be understood that the above description is intended to be illustrative and not restrictive. Many embodiments and applications other than the examples provided would be apparent upon reading the above description. The scope of the invention should be determined, not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. It is anticipated and intended that future developments will occur in the technologies discussed herein, and that the disclosed systems and methods will be incorporated into such future embodiments. In sum, it should be understood that the invention is capable of modification and variation. [0022] All terms used in the claims are intended to be given their broadest reasonable constructions and their ordinary meanings as understood by those knowledgeable in the technologies described herein unless an explicit indication to the contrary in made herein. In particular, use of the singular articles such as “a,” “the,” “said,” etc. should be read to recite one or more of the indicated elements unless a claim recites an explicit limitation to the contrary.

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RELATED APPLICATIONS [0001] The present application claims priority to the U.S. Provisional Application Ser. No. 61/554,661, filed on Nov. 2, 2011, by Haakansson et al., and entitled “EDIBLE DOG TOYS,” the entire disclosure of which, including any drawings, is incorporated by reference herein. FIELD OF THE INVENTION [0002] The present invention is in the field of edible animal toys. SUMMARY OF THE INVENTION [0003] Disclosed herein is an edible animal toy comprising: a body, wherein the body consists of animal edible material; wherein the body comprises at least one hole opening into a hollow interior, wherein the hollow interior is configured to receive edible treats. [0004] Also disclosed herein is an edible animal toy prepared by the process of: mixing two or more edible ingredients to prepare a dough; shaping the dough in a shape of a body having a hollow interior; and baking the shaped dough to obtain the edible animal toy. [0005] Also disclosed herein is a method of preparing an edible animal toy, the method comprising: mixing two or more edible ingredients to prepare a dough; shaping the dough in a shape of a body having a hollow interior; and baking the shaped dough to obtain the edible animal toy. DETAILED DESCRIPTION OF THE EMBODIMENTS [0006] Disclosed herein are edible animal toys having a hollow interior and at least one opening to the hollow interior. The opening is configured to allow treats and edible objects to be placed into the hollow interior. An animal, such as a household pet, for example a cat or a dog, can methodically remove the edible objects from the hollow interior. [0007] Animal toys having a hollow interior with an opening are known in the art. For example, U.S. Pat. Nos. 7,389,748, 7,591,234, and D624,711, all of which are incorporated by reference herein in their entirety, including the drawings, disclose animal toys where an edible treat or food item can be placed inside of the toy, to be removed by the animal. The challenge of removing the edible object from the toy provides long periods of amusement for the animal and prevents rapid boredom and disinterest. [0008] The animal toys disclosed herein are different from those described in the aforementioned U.S. patents. The body of the presently described toys is made of edible materials, whereas the aforementioned U.S. patents describe a toy whose body is made up of inedible polymeric materials, such as plastic or rubber. Having an edible body provides further advantages to the toy. For example: Animals are attracted to the smell of the edible toy and prefer the edible toy to the inedible one. Consequently, the edible toy makes it possible for an otherwise uninterested animal to get the benefits of the mental stimulation and exercise that the inedible toy provides to the interested animal. Similarly, an animal that normally does not play with rubber/plastic/inedible treat toys is attracted to and plays with the edible treat toy. Senior dogs who have lost the interest and enthusiasm for inedible treat toys are newly motivated to play with an edible treat toy. Dogs with health issues, such as loss of sight or hearing, have an easier time playing with the toy since they can more easily target it using their sense of smell. Certain inedible toys break down into pieces over a period of time. This creates certain negative effects, such as dispersed debris or intestinal blockage when the animal ingests the piece. The edible toys are designed to be safely broken down and eaten by the animal. Some animals have allergies to plastic or rubber. These animals can get the benefit of the mental stimulation that the toy offers by using the edible toy. The edible toys do not require any cleaning or maintenance since they are always in the process of being broken done by the dog as it's playing with the toy. The edible toys can be formulated to meet specific dietary needs. As discussed herein, the edible toys of the present invention are configured to contain edible treats. Unlike with plastic, rubber or plush toys, when the treats are emptied the edible toy is still engaging and desirable to play with for the dog. It is an ongoing motivator even when the treats are gone. The edible toys engage a dog's hunting instincts and prey drive from the outset. It is not necessary to train the dog on how to use it unlike with plastic/rubber/plush treat toys that require initial training. [0018] In some embodiments, the body of the edible toys disclosed herein is made up of baked materials. In other embodiments, the body of the edible toys disclosed herein is obtained through an injection molding process. In these embodiments, an edible dough is used instead of the traditional rubber or plastic in the injection molding process. In either case, the dough is cured, either by heating or by any other curing process. In some embodiments, the cooling of the dough after baking or injection molding is curing. Once the dough is cured it hardens. The hardening can be either due to the “cooking” or the drying of the dough. The cured dough, in certain embodiments, is hard so that it provides a challenge to the animal that prefers chewing hard objects such as bones or pieces of wood. However, the cured dough exudes an aroma and provides a taste that is attractive to the animal and maintains its interest in the toy. Baked animal toys, and edible animal toys obtained through injection molding process are known in the art and any number of them can be used with the present toys. Yet, in some embodiments, the edible toys can be formulated to meet specific dietary needs. [0019] The dough for the body of the toy can be shaped in any shape prior to curing. After the toy is cured, the toy will retain that shape. For example, the toy can be made in the shape of a bone, a cylinder, a sphere, or other shapes that are both aesthetically pleasing and are interesting to animals. [0020] In some embodiments, the toy is molded and cured in separate pieces, for example two separate halves or three or four or more separate parts. By this method, the hollow interior and the at least one opening can be created by forming depressions in the dough. After the separate parts are molded and cured, they can be put together and sealed with edible glue or similar materials. In some embodiments, the separate parts are cured partway, i.e., to the point where the part will retain its shape, and then the various pieces are put together to form the toy and sealed with more of the same dough. The complete toy is then cured further to obtain the desired firmness. Thus, in these embodiments, the “glue” is more of the same dough and the toy will present a seamless exterior. [0021] In some embodiments, the edible food or treat is placed inside the depressions before the separate parts of the edible toy are joined before curing. In these embodiments, the treat cures or bakes along with the toy. In some of these embodiments, the toy provides a greater challenge for the animal to extract the treat because the treat can be larger than the opening. In certain of these embodiments, the treat is also baked goods, but is softer than the body of the toy. In some embodiments, the treat completely fills the hollow interior. In these embodiments, the toy is analogous to a cream-filled cannoli, having a softer interior treat enclosed within a harder edible body. In other embodiments, the treat is in several smaller pieces that can move or rattle around inside of the toy, analogous to a chocolate egg having smaller pieces of candy enclosed within it. [0022] In some embodiments, the various parts are made up of different types of dough. These toys provide a more colorful exterior, which is pleasing to the animal owner, while at the same time provide a variety of tastes for the animal that prevents boredom and maintains the animal's interest in the toy. [0023] The hardness of the cured material can be varied depending on the targeted animal. Primarily, the toy must be hard enough to provide a chewing or gnawing challenge to the animal. At the same time, the toy must not be so hard that it does not flake off to provide tasteful enjoyment. Larger animals having stronger teeth and jaw muscles will require toys that are harder than smaller animals. It is well-known in the art to make cured animal treats of varying hardness. [0024] In some embodiments, the opening is large enough to allow the animal owner to insert treats into the toy, but not too large so that the treat would immediately be released from the toy. In some embodiments, the opening has flaps that are made up of softer edible material. The flaps bend inward and allow the treat to enter the hollow body of the edible toy but provide a temporary barrier for the treat's exit. [0025] In some embodiments, the dough comprises one or more of the following ingredients: one or more types of starch, one or more types of oil, one or more types of protein, one or more types of fruit, one or more types of vegetable, one or more types of flavoring, one or more types of supplements, one or more types of stabilizers or preservatives or other miscellaneous ingredients. [0026] In some embodiments, the starch is selected from the group consisting of rice, wheat, potato, corn, brown rice flour, white rice flour, rice powder, barley, oats, sweet rice flour, tapioca starch, oat fiber, and potato starch. [0027] In some embodiments, the oil is selected from the group consisting of flaxseed, chia seed, fish oil, sesame oil, hemp seeds, and mixed tocopherols. [0028] In some embodiments, the protein is selected from the group consisting of chicken meal, chicken, beef, fish, pork, turkey, meat, liver, corn gluten, gluten, soy, soy protein concentrate, peanuts, and peanut meal. [0029] In some embodiments, the fruits and vegetables are selected from the group consisting of pumpkin, sweet potatoes, alfalfa, cranberries, parsley, dehydrated carrots, blueberry, pomegranate, apple, assorted vegetables, tomato, and peas. [0030] In some embodiments, the flavoring is selected from the group consisting of garlic, brewers yeast, peppermint oil, mint, garlic powder, hickory, mesquite, fennel seed powder, parsley oil, green tea extract, vanilla, natural chicken flavor, rosemary, ginger, anise, carob, dill, cinnamon, pumpkin flavor, and peppermint. [0031] In some embodiments, the binder is selected from the group consisting of glycerin, gelatin, lecithin, carageenan gum, water, cellulose powder, dionized water, vegetable gum, and pectin. [0032] In some embodiments, the supplement is selected from the group consisting of calcium carbonate, cholecalciferol, taurine, fructooligosaccharides (FOS), bacillus coagulants, L-carnitine, glucosamine hydrochloride, chondroitin sulfate, capsaicin, dl-alpha tocopheryl acetate, and L-ascrobyl-2polyphosphate. [0033] In some embodiments, the miscellaneous ingredient or stabilizer or preservative is selected from the group consisting of colorings, tricalcium phosphate, citric acid, sodium hexametaphosphate, sodium diacetate, sodium tripolyphosphate, and titanium dioxide. [0034] In one embodiment, the edible toy, as disclosed herein, comprises the following ingredients: rice flour, vegetable glycerin, gelatin, water, cellulose powder, calcium carbonate, sweet potatoes, lecithin, carrageenan gum, natural pumpkin flavor, garlic, brewers yeast, and peppermint oil. [0035] Those of skill in the art recognize what ingredients to choose for a particular line of edible toys. For example, a high protein edible toy is prepared to meet the needs of a particular dog that may be on a high protein diet. Similarly, a toy is prepared with no protein at all but with starch and various flavorings for a dog who may be on a low protein diet. Various vitamins and supplements are introduced into the toys to fit the needs of various dog populations. [0036] As noted above, the edible toys disclosed herein are baked or prepared by injection molding. In some embodiments, the ingredients are selected for the particular line of toy (e.g., a high protein, a low protein, or a high vegetable line of toys). The ingredients are mixed and kneaded into a dough. In some embodiments the kneading is performed manually whereas in other embodiments the kneading is performed by a motorized mixer. The dough is shaped into the desired shape and the shaped dough is placed in an oven for baking. [0037] In the embodiments where the edible toy is prepared by the injection molding process, the ingredients are selected, as discussed above, and blended, mixed, or extruded to form homogenous pellets. Using methods known in the art, the pellets are then processed into a molded article utilizing injection molding, compression molding, transfer molding, pressure forming, or other similar molding methods. The molded article is then removed from the molding machine and cooled.

1a

This application is a National Stage application of PCT/IT95/00147, filed Sep. 7, 1995. TECHNICAL FIELD The present invention relates to a machine employed for rolling or flattening pastry or dough and for shaping it into circular disks provided with an unpressed peripheral edge, preferably used to produce and prepare pizza pies, tarts, cakes, etc. BACKGROUND ART Machines and devices designed for rolling pastry to be used for making pizza pies, are already known. However, they have two drawbacks: the pastry or dough is not flattened or rolled in the same way as during manual kneading, instead it is pressed, thereby giving the pastry features which lower the quality of the final product after baking; the sheet of pastry does not have an edge projecting upwardly (which must be evident and more spongy than the remaining part of the dough after baking), and said edge must be manually formed by the pizza chef around the periphery of the sheet of pastry which was obtained by the machine. In practice, there does not exist a machine and/or a device which rolls or flattens pastry into circular disks provided with a peripheral edge, regardless the diameter of the disk, and which in any case can provide a peripheral edge in which the pastry is neither squeezed nor cracked. SUMMARY OF THE INVENTION Disclosure of Invention The object of the present invention is to provide a machine suited for preparing disks of pastry used for making pizza pies, which allows realization of disks of different diameters, always having a peripheral edge, and with features, like sponginess of pastry, identical to those of pizza pies manually prepared by skilled pizza chefs. The present machine also allows preparation of a disk of pastry without a peripheral edge, in order to manufacture other characteristic products like the so-called "piadina romagnola", and "tigella montanara" etc. According to the present invention this object is attained by a device of the aforementioned kind, characterized in that it comprises two disks or plates: a lower one which is rotated by a motor and on whose upper face there are added or formed spiral-like helices, and an upper plate or disk which does not rotate and which is formed either by a set of circular rings which are concentric and axially mutually sliding each one more inwardly with respect to the preceding one, or by radial sectors which are hinged to a central part. The upper plate or disk is lowered parallel with respect to the lower one while the latter is rotated. While bringing the two plates nearer to each other the mass of pastry put between the plates, at their center, is gradually flattened starting from the center towards the outside, and a peripheral edge formed by the pastry which has not yet been flattened will always be present. The amount of pastry which has been interposed between the plates or disks, and the stopping of the lowering of the upper plate at a suitable instant, will set the dimension of the disk diameter and its thickness. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the invention, two embodiments thereof will now be described, referring to the annexed drawings, which are illustrative and non limitative and in which: FIG. 1 schematically shows the machine of the present invention, according to a partial sectional diametrical view along the plane indicated by I--I in FIG. 2; FIG. 2 is a plan view of FIG. 1; FIG. 3 shows, according to a plan view, the particular form of the upper plate or disk, according to a first embodiment employing circular concentric rings; FIG. 4 is a diametrical cross section of the upper plate, obtained along the plane indicated by IV--IV in FIG. 3; FIG. 5 is a diametrical cross section of the upper plate or disk, according to the plane indicated by V--V in FIG. 3; FIG. 6 is a view of FIG. 3 in the direction of the arrow VI; FIG. 7 is a plan view of the upper plate, identical to FIG. 3, in which there is also shown the device including the idle wheels, used to push the cams of the rings which make up the plate or disk itself; FIG. 8 is a sectional diametrical view of the upper plate or disk, along the plane VIII--VIII of FIG. 7, and it schematically shows the device which allows to lowering one after the other the different circular rings making up the upper plate; FIGS. 9 to 12 schematically show successive steps of the cycle for flattening the pastry, and how the peripheral edge in the disk of pastry is formed according to the first embodiment; FIG. 13 shows the preparation of a disk of pastry or dough having no edge; FIG. 14 shows according to a top view of the particular construction of the upper plate of the second embodiment of a machine for rolling pastry, of a kind comprising radial hinged sectors, which is also suited to realize the invention; FIG. 15 is a diametrical section of the upper plate, obtained along the section segment indicated by XV--XV in FIG. 14; FIG. 16 is a top view of the upper plate, identical to FIG. 14, in which the device comprising the idler wheels is also shown, and which is used to press the cams or projections of the sectors which make up the plate itself; FIG. 17 is a diametrical cross section of the upper plate, along the plane denoted by XVII--XVII in FIG. 16, and it schematically shows the device which allows to gradually lowering of the different sectors composing the upper plate; FIGS. 18 and 19 respectively show, in detail, according to two orthogonal views, a side view and a top view of the lower disk provided with spiral-like helices, FIG. 20 is a diametrical cross section along the plane denoted by XX--XX in FIG. 18 and shows in detail how the projecting spirals may be formed on the disk. In the different figures, the same alphanumeric reference signs denote the same parts or elements. DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIGS. 1 to 13 there is shown a first embodiment of a machine for rolling or flattening pastry, in order to prepare circular disks of pastry of variable thickness provided or not with a peripheral edge, wherein the machine includes the improvements of the present invention. With reference to FIGS. 1 to 8, reference numeral 1 denotes the bed of the machine inside which the ratio-motor 2 is located and fixed, said motor being used for rotating the lower disk 3 including one or more projecting spirals 4 which are either composed of added material or are directly obtained from the disk. A sheet 5, of a suitable kind, adheres to the spirals and is fixed to the bed 1. On the bed 1 there are fixed two vertical guide rods 6,7 on which the bracket 8 can slide, being driven by a linear actuator 9. The bracket 8 supports the upper plate 10, which mainly comprises, according to a first embodiment: a cover 11 fixed to the bracket 8; a central plate 12 provided with one or more brackets 13 which support circular rings 14,15,16,17 by means of screws 18 which are screwed in them and whose head 18/a slides inside seats obtained in the brackets 13; torsion springs in the form of helicoidal springs 19 acting between the bottom of said seat and the head of the screws 18, forcing the rings 14,15,16,17 to abut the lower surface of said brackets 13. The rings 14,15,16,17 are concentric to the central plate 12 and slide axially on each other. The brackets 13 are in contact With the cover 11 and are fixed to it. On each ring 14,15,16,17 there are obtained or added three (projecting) sectors 14/a,15/a,16/a,17/a which start by forming a slope 14/b,15/b,16/b,17/b which provided a tapered variable thickness, thereby acting like a cam or eccentric contoured surface (see also FIGS. 5,6). On the cover 11 there are mounted three adjustable thin bearing rods which will contact three bearing points provided on the bed 1 when the actuator 9 lowers the bracket 8. The adjustment of said thin bearing rods sets the distance at which the central plate 12 is stopped With respect to the spiral 4 of the lower plate or disk, and therefore also the final thickness of the disk of pastry or dough which must be obtained. Centrally, in a suitable hub provided on the cover 11, there is inserted a small spindle 21 (FIG. 8) on those upper end there is formed (or mounted) a toothed pinion 22 associated to a rack 23 driven in both directions by a linear oleodynamic actuator 24 fixed to the cover 11. Three arms 25 (FIG. 8) are interposed between the inner surface of the cover 11 and the circular rings 14,15,16, 17, said arms being connected to a small block 26 which supports them, this block being fixed to the spindle 21. On each arm 25 there are inserted six wheels (or radial bearings), two of them, idler wheels denoted by 27 and 28, are in contact only with the inner plane of the cover 11, whereas the other four wheels can interact only with the cam-like sectors 14/b,15/b,16/b,17/b when, by means of the linear actuator 24, the small spindle 21 is rotated in the direction of the arrow F2, together with the corresponding wheel supporting arms 25. Thereby, each set of three wheels (one for each arm 25) acts on the cams of the same ring, which lowers until it is flush with the small central plate 12. On the rings, the cam-like sectors are disposed in sequence so that each ring starts lowering when the preceding one is already flush with the small central plate 12. The two small wheels 27,28 which bear on the cover 11, on its inside, prevent the arms 25 from bending upwardly due to the thrust transmitted to the wheels interacting with the cam-like sectors. A disk made of TEFLON (polyterafluroethylene ) coated cloth 30 may cover both the small central plate and the circular rings. If the central small plate and the circular rings are manufactured with great precision and with a material suited for foodstuffs, it is possible to avoid use of the cloth 30. Thereby, when the plates or disks are separated from each other, each circular ring acts as a separating means in the sense that it assists in detaching the pastry or dough from the adjacent ring (if it adheres to it). In the rest position, the small wheels are not in contact with the cam-like sectors (FIG. 7). The operation of the device is the following: after starting the ratio-motor 2 by means of an appropriate oleodynamic actuator control unit (not shown) which may or may not be incorporated in the machine, the actuator 9 lowering the bracket 8 is operated; when the small bearing rods 20 bear on the bed 1 and the descent stroke is stopped, the pressure inside the oleodynamic circuit increases; a sequence valve which has been calibrated to a preset value opens itself and operates the linear actuator 24 which rotates the spindle 21, causing the successive lowering of the rings 14,15,16,17. It is obvious that the lowering may be stopped at any time, that is: immediately after the small bearing rods 20 touch the bed; after lowering of the first ring 14; and so on. FIGS. 9 to 12 show the manufacturing cycle of the disks of pastry: when the machine is not running, or when the ratio-motor 2 and the oleodynamic actuator control unit are started, a piece of pastry 29 is put at the center of the lower plate (FIG. 9); the actuator 9 is operated. When the small bearing rods 20 stop on the bed 1, the pastry 29 has flattened as shown in FIG. 10 and forms a central zone (whose diameter equals the diameter of the small central plate 12) having already the desired final thickness "S" which is set by the adjustment of the small bearing rods 20, and a large edge 29/a which is composed of the mass of pastry in excess; when the sequence valve starting linear actuator 24 it released, the first ring 14 lowers (FIG. 11), and successively all the remaining ones, until the final situation depicted in FIG. 12 is reached, wherein the disk of pastry has a corresponding small final edge 29/b. By varying the pastry amount 29 and the thickness "S", it is possible to obtain: disks of pastry, comprising an edge, of as many different diameter sizes as the number of rings increased by one. In the illustrated example we have five disks of different diameter, for making pizza pies or tarts; disks of different diameter size but without edge (FIG. 13), for the preparation of cakes, "tigelle montanare", "piadine", etc. This embodiment, as shown and described above, is not the only one possible. Accordingly, a machine for flattening or rolling pastry according to the present invention, may be different than the kind comprising circular concentric axially slidable rings, but of a kind including hinged sectors (FIGS. 14 to 17), wherein 12/a denotes the central small plate, which in the present case has an hexagonal form and is provided with six brackets 13' to fix it to the cover 11. To the central small plate 12/a there are connected, through hinges 37, a plurality of sectors 31 which are peripherally raised by means of traction springs 32 acting between hooks 33, mounted on or integral with sectors 31, and hooks 34, which are fixed to or integral with the brackets 13'. On each sector 31, in a similar way as has been done for the rings 14,15,16,17 of the previously described embodiment, a tapered variable thickness cam 35/a,35/b is added to or formed integral with the sector, whereon a wheel 36 acts, whereas a small idler wheel 28, which is also freely rotatable, rolls bearing on the inside surface of the cover 11, as in the previous embodiment. The small idler wheel 28 and wheel 36 are mounted on the arms 38, which are mounted and driven by means of the linear actuator 24 and the rack 23, exactly in the same way as in the embodiment employing concentric circular rings, for the purpose of gradually lowering the sectors 31, when the pastry is to be flattened starting from the center towards the periphery. As may be observed, both embodiments are similar: in the embodiment employing pivoting sectors, their number may be different from six; the thickness of the pastry is always determined through the adjustment of the small bearing rods 20, and the pastry is gradually flattened from the center towards the periphery as the sectors are lowered through the thrust of the small wheels on the variable thickness cam-like sectors. Substantially, the operation of the machine is the same as that already described for the embodiment employing circular concentric rings. In both embodiments, the lower disk 3 carrying the spirals 4 plays a fundamental role, influencing the flattening of the pastry and the execution time. The number of turns to impart to the lower disk 3 is determined by the number of spirals 4 which are present on its face, and by the property of the mixture composing the pastry. If necessary, the ratio-motor 2 may be replaced by a stepless speed change gear or by a ratio-motor combined with a change gear with many speed levels. Industrial Applicability The two embodiments which have been shown and described refer to the realization of machines employed in pizza-restaurants, restaurants, snack-bars, etc. The operational principles which are illustrated by them, that is a lower rotating plate provided with spirals forming projections and an upper plate formed by concentric rings or sectors, may be used to realize automatic plants (or lines) for the industrial production of pizza-pies (for instance). An automatic line is an automatized multiple station transfer machine wherein in the lower part of every station there is provided a motor driven lower disk or plate 3 carrying spirals 41 in the upper part of every station there is a plate or disk whose central small plate 12 or 12/a has a diameter size which becomes larger for each successive station according to the desired number of passages or stations which, as established in advance, divides up the cycle for flattening the pastry. The advantages with respect to the present industrial production lines of pizza-pies, are the following: the yield and heating of the pastry are as low as possible since the flattening or rolling of the pastry is divided up in more steps; the period of every cycle is reduced to the time required for a single step, with an obvious noticeable increase of productivity. As will be obvious from the description given above of two preferred embodiments, the invention is not limited to the example mentioned, which has been presented only for illustrative purposes. It must be understood that other steps, examples, constituent parts and methods of operation will spontaneously originate in the mind of one skilled in the art after an attentive reading of the present disclosure, even if this is not to be considered unrelated to the scope of the invention as the latter is claimed hereinafter:

1a

This is a continuation of application Ser. No. 08/033,649, filed Mar. 17, 1993, now abandoned, which was a continuation-in-part of application Ser. No. 07/862,207, filed Apr. 2, 1992, now abandoned. FIELD OF THE INVENTION This invention relates to rebreathing equipment, and, more particularly, to semi-closed scuba equipment wherein exhaled carbon dioxide is separated and absorbed within the equipment, thereby leaving a portion of the exhaled gases suitable for rebreathing. BACKGROUND OF THE INVENTION A conventional semi-closed rebreathing scuba system is illustrated in FIG. 1 labeled "PRIOR ART". This prior art system 10 includes a supply circuit 12 and a breathing circuit 14. The supply circuit 12 which supplies fresh breathable gas (not yet inhaled) to the breathing circuit 14 includes a pressurized tank 16, a regulator 18 and a flow control device 20. The breathing circuit 14 includes an expandable respiration bellows 22 connected to an inhalation conduit 24 which, in turn, is connected to a mouthpiece assembly 26. An outlet portion of the mouthpiece assembly 26 is connected to an exhalation conduit 28 which reconnects to the respiration bellows 22 through a carbon dioxide absorber 30. The respiration bellows 22 also includes an outlet valve 32 allowing a controlled amount of gas to exit the system (hence the term, semi-closed). In operation of this prior art rebreathing system, the pressurized air from the supply circuit 12 is introduced into the breathing circuit 14 at the respiration bellows 22. The fresh supply-gas is mixed in the respiration bellows 22 with the exhaled gas that has passed from the diver (not shown) through the outlet side of the mouthpiece assembly 26, the exhalation conduit 28, the carbon dioxide absorber 30 and into the respiration bellows 22. As the diver inhales, the mixed gas from the bellows 22 is forced through the inhalation conduit 24 and the inlet portion of the mouthpiece assembly 26. The mouthpiece assembly 26 includes one-way check valves to prevent the direct rebreathing of any exhaled gas and to otherwise ensure the proper transfer of gases between the diver and the rebreathing equipment. As this breathing cycle is repeated around the breathing circuit 14 of the breathing system 10, waste gases, including carbon dioxide, expired by the diver, are removed from the breathing circuit 14 by the carbon dioxide absorber 30. Waste gas that is removed from the breathing circuit 14 is replaced with a supply of fresh gas from the supply circuit 12. The regulator 18, the flow control device 20, the expandable respiration bellows 22 and the outlet valve 32 work together to ensure that the pressure of the gas within the breathing circuit 14 remains at a constant and safe level regardless of the surrounding environment. One problem with the above-described prior art semi-closed scuba breathing system relates to the handling of moisture introduced into the breathing circuit 14. Water may enter the breathing circuit 14 in the form of water vapor carried by the exhaled gases of the diver or through a leak in the system from the outside environment. In either case, water has a detrimental effect on the carbon dioxide absorber, effectively reducing the ability of the absorber to remove waste gas from the breathing circuit 14. Any water entering the exhalation conduit 28 of the prior art system of FIG. 1 will pass directly into the carbon dioxide absorber 30, and prematurely render the absorber 30 ineffective. Additionally, water entering the breathing circuit 14 will eventually accumulate in the respiration bellows 22. Depending on the orientation of the diver, the accumulated water in the respiration bellows 22 may easily enter the inhalation conduit 24 of the breathing circuit 14 and endanger the safety of the diver. It is an object of the invention to provide a semi-closed rebreathing apparatus which overcomes the above-mentioned problems. It is another object of the invention to provide a semi-closed rebreathing apparatus which automatically removes any water accumulated within the system. It is yet another object to increase the time span during which a carbon dioxide absorber within a rebreathing system will remain effect. It is still another object to provide an improved semi-closed rebreathing system for firefighting and other environments. SUMMARY OF THE INVENTION A respiration system for use by a scuba diver, firefighter or the like, includes a carbon dioxide absorber. At least a portion of any water contained in the exhaled gases is removed from the system before the exhaled gases reach the carbon dioxide absorber. The respiration system includes a supply of pressurized breathable gas connected to a first expansion chamber. A mouthpiece is provided for passing breathable gas to, and receiving exhaled gas from the user. The mouthpiece has an inlet and an outlet wherein the outlet is connected to the first expansion chamber. Means is provided for mixing the exhaled gas within the first expansion chamber with breathable gas from the breathable-gas supply. Water is removed from the exhaled gas in the first expansion chamber. An inhalation tube connects the first expansion chamber and the inlet of the mouthpiece. The inhalation tube provides communication of the gas mixture of the first expansion chamber and the mouthpiece. Means is provided for absorbing at least a portion of the carbon dioxide from the exhaled gases. The absorbing means is located along the inhalation tube between the first expansion chamber and the mouthpiece. A portion of the breathable gas from the breathable-gas supply is introduced to the inhalation tube between the absorbing means and the mouthpiece to compensate for any gas-flow resistance created by the absorbing means during high demand inhalation by the user. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic of a prior art semi-closed scuba breathing system; FIG. 2 is schematic of a semi-closed rebreathing system in accordance with a first embodiment of the invention; FIG. 3 is a sectional view of a respiration bellows assembly in accordance with another embodiment of the invention; FIG. 4 is a partial sectional top view of the breathing apparatus enclosed in a case in accordance with yet another embodiment the invention; FIG. 5 is an enlarged sectional view of the respiration bellows assembly of FIG. 4; FIG. 6 is an enlarged sectional view of a mouthpiece assembly in accordance with the invention showing a non-purge condition; and, FIG. 7 is an enlarged sectional view of the mouthpiece assembly of FIG. 6 showing a purge condition. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 2, a schematic of a semi-closed scuba breathing apparatus 40 in accordance with the invention is shown including a supply circuit 42 and a breathing circuit 44. The supply circuit 42 of the present breathing apparatus 40 includes a pressurized tank 16 of a breathable gas such as air or pure oxygen, two regulators 18 and 46, a flow control device 20, a second stage inlet conduit 48, a first stage inlet conduit 50 and an inlet control valve 52. The breathing circuit 44 of the present breathing apparatus 40 includes a main respiration bellows 54, an inhalation conduit 24, a carbon dioxide absorber 30, an auxiliary bellows 56, a mouthpiece assembly 26 having an inlet port 25 and an outlet port 27, and an exhalation conduit 28. Both the auxiliary respiration bellows 56 and the main respiration bellows 54 are designed to expand and contract between fully expanded and contracted conditions. The inhalation conduit 24 is made up three segments discussed in greater detail below. A first segment 24a is connected between the main bellows 54 and the carbon dioxide absorber 30. A second segment 24b is connected between the absorber 30 and the auxiliary bellows 56, and finally a third segment 24c is connected between the auxiliary bellows 56 and the inlet port 25 of the mouthpiece assembly 26. The supply circuit 42 supplies a breathable gas to the breathing circuit 44 at two different points, along two supply paths, respectively, a low pressure path 58 and a high pressure path 60. Along the low pressure path 58 breathable gas from the tank 16 passes through appropriate high-pressure conduit, through a regulator 18, through a flow control device 20, and finally to the main respiration bellows 54 via the second stage inlet conduit 48 which is connected to the outlet of the flow control device 20. Along the high pressure supply path 60, breathable gas passes from the tank 16 through a regulator 46 and then through a first stage inlet conduit 50 supplying high pressure gas to the auxiliary bellows 56, the flow of which being controlled by the inlet control valve 52. The main respiration bellows 54 includes an outlet valve 32 for permitting a controlled amount of gas exit from the breathing circuit 44 and enter the outside environment. The main respiration bellows 54 also includes a water removal system 62 for removing any accumulated water from the breathing circuit 44 before the water reaches the carbon dioxide absorber 30 or becomes inhaled by the diver. The water removal system 62 is described in greater detail below. As the diver breathes normally, his exhaled gases leave the mouthpiece assembly through the outlet port 27 and enter directly into the main respiration bellows 54 by way of the exhalation conduit 28. The exhaled gases are mixed in the main respiration bellows 54 with fresh breathable gas entering the breathing circuit 44 from the low pressure supply path 58 of the supply circuit 42. Any water vapor or liquid carried by the exhaled gas into the main respiration bellows 54 will accumulate and will eventually be removed by the water removal system 62, as described below. The exhaled gas and fresh gas mixture continue the breathing circuit 44 by being forced through the inhalation conduit 24, through the carbon dioxide absorber 30 and into the auxiliary respiration bellows 56. Any waste gases from the exhaled/fresh gas mixture, especially carbon dioxide are effectively removed from the breathing circuit by the carbon dioxide absorber 30, as is known. The gas leaving the carbon dioxide absorber 30 is clean and breathable. In completing the breathing circuit 44, the now fully breathable gas enters the auxiliary respiration bellows 56 and, depending on the inhalation demand (described in detail below) may or may not be supplemented by additional fresh breathable gas from the high pressure path 60 before entering the inlet port 25 of the mouthpiece assembly 26 to be inhaled and used by the diver again. The fresh gas entering from the high pressure path 60 is regulated by the inlet control valve 52. The inlet control valve 52 is "open" only when the auxiliary respiration bellows 56 is in its contracted state, i.e., when inhalation demand is high. Referring to FIG. 3, a preferred embodiment of the rebreathing apparatus 40 is shown including the main respiration bellows 54 combined with the auxiliary bellows 56 in a practical, compact unit. A center support plate 64 functions as an end support for both the main and the auxiliary respiration bellows 54, 56, respectively. The auxiliary respiration bellows 56 further includes an upper end plate 66. The main respiration bellows 54 further includes a lower end plate 68. Appropriate flexible bellows material is affixed to the upper end plate 66 and an upper side of the center support plate 64 to form the auxiliary respiration bellows 56. Similarly, the main respiration bellows is formed with the bellows material attached to a lower side of the center support plate 64 and the lower end support 68. The water removal system 62, introduced above, includes a pumping bellows 70 having a sealed upper end 72 and an open lower end 74. The pumping bellows 70 is positioned within the main respiration bellows 54 and operates as the main respiration bellows 54 expands and contracts. The upper end 72 of the pumping bellows 70 is affixed to the lower side of the center support plate 64. The lower end plate 68 includes an integrally formed collection recess 76 which is the lowest point within main respiration bellows 54. Any water located within the breathing circuit 44 will eventually (prior to the water reaching either the diver or the carbon dioxide absorber 30) collect in the collection recess 76 as long as the orientation of the diver for any short period of time permits gravity to pull the water into the collection recess 76. An opening 78 is located in the lower end plate 68 of the main bellows 54, positioned within the collection recess 76, preferably at the center of the recess 76. Mounted within the opening 78 is located a spring-loaded, one-way valve 80. The one-way valve 80 only permits fluid flow (either gas or liquid) to pass out of the breathing circuit 44 when the pressure acting on the inner side of the valve 80 is greater than both the force of the return spring 81 and the acting pressure of the outside environment. The pumping bellows 70 is positioned within the main respiration bellows 54 so that its open lower end 74 resides within the collection recess 76 centered about the opening 78 and the one-way valve 80. The pumping bellows 70 operates between a fully expanded state and a fully compressed state. The length of the pumping bellows 70 when it is in its fully expanded state, as shown in FIG. 3, is preferably slightly less than the distance between the center support plate 64 and the lower end plate 68 of a fully expanded main respiration bellows 54, as measured from within the collection recess 76 (and effectively equals the length of the main bellows 54, fully expanded). The difference in the expanded lengths between the main bellows 54 and the pumping bellows 70 defines an inlet gap 82 through which unwanted water collected within the collection recess 76 may pass, thereby entering the pumping bellows 70. Alternatively, the pumping bellows 70 may extend fully from the center support plate 64 to the lower end plate 68. In this case, the lower end of the pumping bellows 70 would be provided with slits or other means for permitting entry of water from the main respiration bellows 54 into the pumping bellows 70. In operation of the water removal system 62, as the main bellows 54 expands and contracts, the pumping bellows 70, being tightly positioned between the lower end plate 68 and the center support plate 64, is forced to also expand and contract. During expansion, the pressure within the pumping bellows 70 will invariably be less than the pressure within the main bellows 54 (effectively creating a vacuum). The greater external pressure (in the main bellows 54) will force any water, located in the collection recess 76, into the pumping bellows 70. When fully expanded, the inlet gap 82 will equalize the pressures within the pumping and main bellows. During the contraction of the main bellows 54, the pumping bellows 70, with its drawn water is forced to also contract. As the pumping bellows 70 contracts and contacts the lower end plate 68, the inlet gap 82 will close and the pressure within the pumping bellows 70 will increase. Eventually, the pressure within the pumping bellows 70 will exceed both the force of the return spring 81 of the one-way valve 80 and the pressure of the outside environment, thus forcing the water from within the pumping bellows 70, past the temporarily open one-way valve 80, and out of the breathing circuit 44. The compact breathing assembly shown in FIG. 3 operates similar to the system shown in FIG. 2. Again, fresh gas enters into the breathing circuit 44 from the supply circuit 42 through the second stage inlet conduit 48 and the first stage inlet conduit 50. The high pressure fresh gas entering the auxiliary bellows 56 is controlled by the inlet control valve 52. As discussed above, the inlet control valve 52 opens only when the auxiliary bellows 56 is in its collapsed state. The control valve 52 is preferably forced open through direct contact between an actuator arm 84 (used to open the inlet control valve 52) and a contact member 86 formed integrally with the upper end plate 66 of the auxiliary bellows 56. The third segment 24c of the inhalation conduit 24 and the exhalation conduit 28 both extend from the mouthpiece assembly 26 (not shown in FIG. 3) and are preferably affixed to their respective upper and lower side of the center support plate 64. In the breathing apparatus shown in FIG. 3, the carbon dioxide absorber 30 is preferably positioned within a recess 88 formed in the upper end plate 66 of the auxiliary bellows 56. An appropriate cover plate 90 covers the recess 88 and secures the carbon dioxide absorber 30 within the recess 88. The recess 88 includes an inlet opening 92 which is connected to a flexible first segment 24a (see FIG. 2) which, in turn is connected to the main bellows 54, through an opening 93 formed in the center support plate 64. The flexible conduit 24a functions only to provide fluid communication from the main bellows 54 to the carbon dioxide absorber 30, without restricting or otherwise limiting the independent movement of the auxiliary bellows 56. Another opening not shown in FIG. 3 is provided within the recess 88 to function as segment 24b of the inhalation conduit 24 (see FIG. 2) to effectively provide fluid (gaseous) communication from the carbon dioxide absorber 30 to the auxiliary bellows 56. By repositioning the carbon dioxide absorber 30 from within the exhalation conduit 28 of the prior art breathing system (see FIG. 1) to within the inhalation conduit 24, the water-sensitive absorbing element 30 is protected from exhaled water vapor (and liquid). The purpose of the auxiliary bellows 56 and the high pressure path 60 of fresh gas is to compensate for any restriction to the inhalation gas-flow created by the carbon dioxide absorber 30 so that the diver is not unduly burdened as he breathes. In operation of the auxiliary bellows 56, as the diver inhales, the immediate loss of air from the auxiliary bellows 56 will cause the bellows 56 to collapse. Under normal breathing, even the restricted flow of gas from the carbon dioxide absorber 30 should be sufficient to re-inflate the auxiliary bellows 56 prior to the next breath by the diver. However, should the demand for fresh gas at the mouthpiece assembly 26 be so great as to completely collapse the auxiliary bellows 56 prior to the bellows 56 being re-inflated by the relatively slow restricted gas flow through the carbon dioxide absorber 30, the actuator arm 4 will be triggered through direct contact with the contact member 86, if only for a short moment. The actuator arm 84 will open the inlet control valve 52 which will allow high pressure fresh gas to enter the breathing circuit 44 at the auxiliary bellows 56. The sudden high pressure supply of gas will cause the auxiliary bellows 56 to immediately re-inflate. As the auxiliary bellows 56 expands past a predetermined point, the contact pressure to the actuator arm 84 will cease, thereby automatically re-closing the inlet control valve 52 and the high pressure supply of fresh gas. The breathing demand of the diver is therefore automatically met by the self-regulating auxiliary bellows 56 switching, as necessary, between a slow but efficient fresh gas supply and an immediate "on call" (yet less efficient) supply. Referring to FIGS. 4 through 7 another embodiment of the present breathing apparatus is shown enclosed in a casing 94 to be worn on the back of a scuba diver (not shown). The breathing apparatus of FIGS. 4 and 5 is similar to the breathing apparatus described above and shown in FIGS. 2 and 3, yet here the problem being addressed relates to the effect which differences in ambient hydrostatic pressure have on both the main bellows 54 and the auxiliary bellows 56 as the diver maneuvers within the water environment. The construction of the apparatus positions the relatively heavy assembly containing the carbon dioxide absorber 30 to the upper end plate 66 of the auxiliary bellows 56 so that its weight forces the auxiliary bellows 56 to either compress or retract according to the diver's orientation as he swims. The added force supplied by the weight of the assembly containing the carbon dioxide absorber 30 is meant to help simulate a human lung by maintaining the pressure within the main bellows 54 and the auxiliary bellows 56, as further explained below. As the diver wearing the casing 94 containing the breathing apparatus of FIG. 4 swims with his abdomen facing the ground (or sea floor), the hydrostatic pressure at the depth of the diver's lungs is greater than that at the depth of the main bellows 54 or auxiliary bellows 56. In this position, the weight of assembly containing the carbon dioxide absorber 30 drawn by gravity applies force to the auxiliary bellows 56 and the main bellows 54 urging them to collapse towards the diver's back (and towards the sea floor). The result here is that the internal pressure is maintained similar to that of a human lung. If, on the other hand, the main bellows 54 and the auxiliary bellows 56 are contracted and the diver is in an inverted orientation, i.e., with his back facing the sea floor, the relatively heavy assembly containing the carbon dioxide absorber 30 will be drawn by gravity to help expand the auxiliary bellows 56 and the main bellows 54, against the slightly greater hydrostatic pressure at the depth of the bellows 54, 56. The rebreathing apparatus of FIGS. 4 and 5 includes, as before, a tank 16 connected to a regulator 98, an auxiliary bellows 56, a main bellows 54, an inhalation conduit 24, an exhalation conduit 28 and a mouthpiece assembly 26. A supply conduit 96 is connected between the regulator 98 and a flow control device 100. A filter 102 is positioned in-line between the regulator 98 and flow control device 100. Also, a diver's hand-held pressure gauge assembly 104 is connected via an appropriate conduit 106 to the regulator 98. The outlet of the flow control device 100 is connected to an inlet conduit 112 directly into the main bellows 54. The flow of gas into the main bellows 54 from the inlet conduit 112 is controlled only by the regulator 98 and the flow control device 100. A purge supply conduit 110 also extends from the regulator 98 directly to the mouthpiece assembly 26, as described further below. Similar in operation to the above-described inlet control valve 52, an inlet control valve 114 provided with an actuator arm 116 controls the flow of breathable gas into the auxiliary respiration bellows 56. A contact member 118 is now formed integral with the upper end plate 66 and directed downward into the auxiliary bellows 56. In operation, should inhalation force the auxiliary respiration bellows 56 to collapse, thereby causing the upper end plate 66 to approach the center support plate 64, the contact member 118 will eventually contact the actuation arm 116 and "open" the control valve 114. Once "opened", the control valve 114 passes fresh breathable gas from the regulator 98 directly into the auxiliary respiration bellows 56 which expands the auxiliary bellows 56 to an acceptable level. The control valve 114 operating with the contact member 118 automatically regulates and retains the inflation of the auxiliary bellows 56. Referring to FIGS. 6 and 7, a mouthpiece assembly 26 in accordance with the invention is shown having three main connecting conduits, an inhalation conduit 24c, and exhalation conduit 28 and the purge supply conduit 110 connected to the mouthpiece assembly via a purge supply inlet 126. The mouthpiece assembly 26 includes a respiration chamber 120 to which is connected the inhalation conduit 24c, the exhalation conduit 28, a mouthpiece element 122, a purge outlet valve 124 and the purge supply 110. The inhalation conduit 24c supplies breathable gas to the diver. As the diver inhales, gas from the inhalation conduit 24c passes a spring-loaded, one-way check valve 128, enters the respiration chamber 120 and finally, is inhaled by the diver through the mouthpiece element 122. As the diver exhales, the exhalation gases are directed through an exhale outlet passageway 123, past a spring-loaded, one-way check valve 130 and into the exhalation conduit 28. The two spring-loaded check valves 128, 130 ensure that the diver receives breathable gas only from the inhalation conduit 24c and, under normal operation, all exhalation gases leave the mouthpiece assembly 26 through the exhalation conduit 28. Water vapor or liquid may enter and accumulate in the respiration chamber 120. A purging system is provided to allow the diver to selectively remove the accumulated water from the respiration chamber 120. The purging system includes the purging supply inlet 126, a purge controller 132 and a purge outlet valve 124. The purge controller 132, which is movable by the diver between a purge and a non-purge position is spring-biased to the non-purge position and includes an accessible end 136, a contact member 138 and a sealing element 140. The supply inlet 126 includes a control valve 142 which is normally closed and actuated by an actuator 144. The actuator 144 is positioned to engage with and be actuated by the contact member 138 of the purge controller 132 only when the purge controller 132 is moved (by the diver) to the purge position, shown in FIG. 7. When the purge controller 132 is moved to the purge position, the actuator 144 "opens" the control valve 142 and the sealing element 140 closes the exhale outlet passageway 123 to direct any supply of purging gas to the purge outlet valve 124 only. As the control valve 142 remains "open", the pressurized gas from the purge supply conduit 110 increases the pressure within the respiration chamber 120. Eventually, the pressure will exceed the force of the return spring of the purge outlet valve 124 and the pressure of the outside environment, at which point any water located at or near the outlet valve 124 will be forced from the respiration chamber 120. The diver should not inhale during initiation of purging, in order to avoid the water to be purged from being forced into the diver's lungs. Once the water has been expelled from the respiration chamber 120, however, the diver may once again breathe normally. When released, the purge controller 132 automatically returns to the non-purge position, the contact member 138 causes the actuator 144 to close the control valve 142 and the exhale outlet passageway 123 is unsealed. While the invention has been shown and described with respect to the preferred embodiments relating to underwater rebreathing systems, it will be readily observed and understood by persons of ordinary skill, to which the invention pertains, that the described systems are equally applicable to firefighting rebreathing systems and the like, wherein a user must survive in a hostile, nonbreathable environment, with only self-contained, limited resources. The invention is limited only by the claims.

1a

BACKGROUND OF THE INVENTION CROSS-REFERENCE TO RELATED APPLICATIONS This application is a Continuation-In-Part of my co-pending U.S. patent application Ser. No. 06/861,141, filed May 8, 1986, entitled "Brooder Feeding Apparatus". FIELD OF THE INVENTION This invention relates to brooder houses and feeding apparatus for raising poultry and more particularly, to an improved method for feeding baby chicks in a specific brooder area using a brooder feeding apparatus which is characterized by an elongated tube provided with an internal auger, a feed hopper provided at one end of the tube and a control box located at the opposite end thereof, with spaced, valve-equipped drop tubes extending downwardly from the tube or trough and brooder pans located beneath the drop tubes. Feed is carried by the auger from the feed hopper through the tube and is delivered into and accumulated in the drop tubes and finally delivered to the brooder feed pans, through openings located in the tube. The drop tubes are fitted with automatically controlled feed control valves and are sequentially provided with feed for filling, beginning with the drop tube closest to the feed hopper. The control box operates by means of a microswitch to terminate operation of the auger and facilitate distribution of the feed accumulated in the drop tubes when the feed fills the last drop tube pursuant to operation of a timer. In a preferred embodiment of the invention, the entire brooder feeding apparatus is suspended in a centrally-located area in the poultry house and is capable of being raised and lowered by means of supporting cables to facilitate cleaning, adjustment of the height of the drop tubes over the feed pans and removal of the apparatus from the proximity of the brooder floor in the poultry house after approximately 2 to 3 weeks. After feeding the baby chicks for the 2 to 3 week term by operation of one or more brooder feeding apparatus, larger, conventional feeders located outside the brooding area are then used to feed the chicks to a market age of about 61/2 weeks. Poultry such as broilers are typically grown in a poultry house structure measuring approximately 38'×350' long. The poultry house is commonly divided transversely in half by a curtain which extends from the ceiling to the floor, thus making it possible to selectively heat and cool one-half of the structure at a time. This heated area of the poultry house is the area where poultry such as small chickens ("chicks") are kept from birth to approximately 2 to 3 weeks of age, depending upon the outside temperature and prevailing weather. This area is called the brooder area of the chicken house and the chicks must reach several days of age before they will venture out from the brooder area to eat. Accordingly, feeder trays having a diameter of approximately 24 inches and one inch in height are typically placed close to heated brooders in the brooder area, in order to insure that the hatched chicks eat, drink and stay warm until they are about seven days old. At this time, the chicks will begin to venture out of the brooder area and attempt to eat from the larger outside feeder pans. However, these outside feeder pans are typically three inches high and are designed for larger birds, so that many of the chicks starve from lack of feed, if no other source of food is provided during the first few days. Accordingly, the small brooder chicks are usually fed in the brooder feed pans by hand at least twice daily during the first critical seven-day period of time. Each chick eats approximately six-tenths of a pound of feed by the time it is two weeks of age; accordingly, approximately five thousand pounds of feed must be dispensed by hand in the brooder area of a conventional poultry house over a two-week period of time. The chicks will also consume about 3700 pounds of feed from existing larger conventional mechanical feeders by the time they reach two weeks of age, which mechanical feeders are primarily designed to feed only the larger chickens after 2 to 3 weeks of age. The brooder feeding apparatus of this invention delivers feed to the young chicks automatically, at least twice daily, in 5 to 12 minutes of total feed-distribution time, saving extensive hand labor. Most poultry farmers own two to four poultry houses, each with a capacity of about 14,000 chickens. Accordingly, about 10,000-20,000 pounds of feed must be placed in the brooder feed pans by hand during the entire brooding period, while feeding of the larger chickens is accomplished by automatic mechanical feeders. DESCRIPTION OF THE PRIOR ART Typical automatic feeding devices used in poultry houses consist of a feed hopper and power unit combination which delivers feed by operation of a ribbon or "flex" auger positioned inside a tube or a rounded trough. This auger and tube or trough combination extends from inside a feed hopper located at one end of the poultry house to the other end of the structure. The feeder delivers feed to pans of about 3 inches in height which are connected to the primary delivery tube at spaced intervals, in order to receive the feed. The number of pans utilized in the feeding system varies according to the number of chickens to be fed. A small opening at the point of attachment of each pan to the tube or trough allows feed to fall sequentially into the pans, with the filling of the pans proceeding sequentially according to the distance between the respective pans and the feed hopper. The feed is automatically supplied to the hopper by an overhead auger and the existing conventional mechanical feeders are designed to accomodate larger poultry and are located outside the brooding area of the poultry house. In each feeder, the end pan is provided with an enclosure which is fitted with a control tube having a microswitch. The microswitch is designed to interrupt the flow of electric current and stop the auger when feed which is delivered through the entire length of the tube or trough, drops into the control tube and fills the last pan located beneath the control tube. A critical problem in the feeding of baby chicks and particularly, those chicks which are brooded in large poultry houses, is that of supplying feed and water to the chicks during a time period immediately after the chicks are hatched, until about seven days from hatching time. Since the chicks will not initially venture from the brooder area by nature, they must be fed by hand from small trays or feed troughs in the brooding area which have a very short lip or edge to facilitate easy access to the feed. As above noted, the time and logistics required in the dispensing of a considerable quantity of feed by hand in a short period of time frequently results in inadequate feeding of the chicks and many small chicks die as a result of unintentional neglect. Furthermore, conventional auger-operated mechanical feeders set up to feed larger poultry are not designed to feed these small chicks. Pertinent prior art is disclosed in applicant's Information Disclosure Statement which was filed with his co-pending application, Ser. No. 06/861,141, filed May 8, 1986, entitled "Brooder Feeding Apparatus". In addition to this art, other pertinent art of which applicant is aware, includes U.S. Pat. No. 3,415,228, dated Dec. 10, 1968, to L. A. Myers, entitled "Feed Control Apparatus". This patent details a control system for a mechanical poultry feeder, in which a feed-actuated panel switch is provided for stopping a conveyor motor when a predetermined amount of feed has been delivered. Electromagnetic means is provided in the system for holding the panel to prevent operation of the conveyor motor for a predetermined period of time. U.S. Pat. No. 4,337,728, dated July 6, 1982, to Carl Van Gilst, discloses a "Programmed Hog Feeder and Process". This patent details a method for feeding hogs which includes a first step to provide the hogs with all the feed which they care to consume for a limited feeding period and thereafter denying all feed to the hogs for a limited period of time in a second step. The apparatus for carrying out this feeding cycle includes a feed pan or trough, a high capacity feed delivery conveyor and a timed feed shut-off means interposed between the feed trough means and the feed delivery conveyor, for alternately delivering and preventing delivery of feed to the feed trough. An optional water nozzle can be located above the feed trough to deliver water to the hogs during the feeding period and a timed water shut-off means may be interposed between the water nozzle and the water delivery pipe, for alternately permitting and preventing delivery of water to the water nozzle. It is an object of this invention to provide a new and improved brooder chick feeding apparatus which is located in the brooder area of a chicken or poultry house, which apparatus includes a feed distribution system of the auger-tube design which is suspended at various points along the length of the brooder area, in order to better facilitate distribution of feed to the chicks in the brooder area and valving of the drop tubes in the feed distribution system to facilitate precise control of feed rate. Another object of this invention is to provide at least one new and improved brooder feeding apparatus for a poultry house, which brooder feeding apparatus is located in or near the longitudinal center area of the poultry house and is characterized by an elongated tube provided with an internal flex auger and a feed hopper at one end with an automatic cut-off switch at the opposite end, the tube further provided with openings spaced at valve-equipped drop tubes located in spaced relationship along the length thereof, for sequentially delivering feed to the drop tubes in controlled quantities and subsequently depositing the feed in a single operation in shallow feed pans located beneath the drop tubes and further including support cables attached to the feed distribution apparatus for raising and lowering the apparatus for cleaning and maintenance purposes. Still another object of this invention is to provide a new and improved brooder feeding apparatus for poultry houses, which brooder feeding apparatus is designed specifically to locate in a central brooder area of a poultry house and is characterized by an elongated primary tube fitted with support cables and lifting means such as a winch for raising and lowering the primary tube to a selected height above ground level, the primary tube further provided with removable drop tubes fitted with air cylinder and cable-actuated valves located in spaced relationship thereon and valve-controlled openings provided in the tube corresponding to the drop tubes. A feed hopper is located at one end of the tube and a cut-off switch provided at the opposite end, the tube also fitted with a flex auger driven by a microswitch-controlled motor for sequentially moving feed from the feed hopper down the entire length of the tube for distribution to the drop tubes and subsequent delivery into shallow feed pans located beneath the drop tubes, to feed baby chicks in the brooder area only. A still further object of this invention is to provide a new and improved brooder feeding apparatus and method for operating the brooder feeding apparatus, which apparatus includes an elongated pipe or tube fitted with a flex auger therein and a feed hopper at one end for receiving one end of the flex auger, with a control box located at the opposite end of the flex auger and a microswitch-controlled motor provided in close proximity to the control box for driving the flex auger. Further included are multiple valve-operated drop tubes extending from the tube in spaced relationship and holes provided in the tube at the drop tubes for sequentially accumulating feed in the drop tubes and subsequently dumping the feed into shallow feed pans located beneath the drop tubes. Another object of this invention is to provide a method of feeding baby poultry in a poultry house which includes the steps of providing a brooder area in the center section of the poultry house, installing one or more brooder feeding apparatus in this center area and operating the brooder feeding apparatus to dispense feed through specially designed drop tubes into brooder pans for feeding baby poultry. SUMMARY OF THE INVENTION These and other objects of the invention are provided in a method and apparatus for feeding baby poultry in a poultry house, which apparatus includes a pair of brooder feeding devices for location in parallel relationship the central, longitudinal brooder area of the poultry house. Each of the brooder feeding devices is characterized by an elongated tube which may be suspended by cables from the frame or rafters of the poultry house, a winch connected to the cables for raising and lowering the tube and further including multiple cable and valve-operated drop tubes provided in spaced relationship along the length of the tube for selectively receiving feed from a hopper located on one end of the tube or trough, which feed is moved by operation of an auger sequentially to the drop tubes where it is accumulated and then directed into brooder pans. The tube is terminated at the opposite end by a control box fitted with a microswitch operated by an associated timing means for terminating rotation of the auger when a specified quantity of feed has been accumulated in the drop tubes. The feed is then distributed to the brooder pans by operation of the timer after a predetermined period of time has elapsed. BRIEF DESCRIPTION OF THE DRAWING The invention will be better understood by reference to the accompanying drawings, wherein; FIG. 1 is a sectional view of a preferred hopper trough element of the brooder feeding apparatus of this invention, with a feed tube attached thereto; FIG. 2 is a perspective view, partially in section, of a preferred control box element located at the opposite end of the brooder feeding apparatus from the hopper trough element illustrated in FIG. 1; FIG. 3 is a top elevation of a preferred poultry house layout illustrating a preferred centrally-located brooder area and a pair of brooder feeding apparatus located in the brooder area; FIG. 4 is a side view, partially in section, of typical hopper trough, feed tube, drop tube, control box and auger elements of the brooder feeding apparatus of this invention; FIG. 5 is a perspective view of the preferred brooder feeding apparatus elements illustrated in FIG. 4, with the valve control cable removed, for clarity; FIG. 6 is a side sectional view of a preferred line drop tube element of the brooder feeding apparatus illustrated in FIGS. 4 and 5; FIG. 7 is an end sectional view of the line drop tube illustrated in FIG. 6; FIG. 8 is a top sectional view of the control box illustrated in FIG. 2; FIG. 9 is a front view of a mount plate located in the control box for receiving a swing plate disposed for sensing the quantity of feed delivered to the control box; FIG. 10 is a top view of the mount plate illustrated in FIG. 9; FIG. 11 is a front view of the swing plate pivotally carried by the mount plate illustrated in FIGS. 9 and 10; and FIG. 12 is a top view of the swing plate illustrated in FIG. 11. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring initially to FIGS. 1, 2 and 5 of the drawings and particularly to FIG. 5, the brooder feeding apparatus of this invention is generally illustrated by reference numeral 1. The brooder feeding apparatus 1 is further characterized by an elongated feed tube 27, provided with a hopper trough 11 at one end thereof and a control box 43 at the opposite end, as illustrated in FIG. 5. As detailed in FIGS. 1 and 5, the hopper trough 11 is further characterized by parallel trough ends 12 connected by parallel trough sides 13, which trough ends 12 and trough sides 13 taper to define a trough bottom 12a. The trough bottom 12a is closed by a bottom cap 12b, as illustrated in FIG. 1 and a solenoid valve-operated air cylinder 63 is attached to the bottom cap 12b, for purposes which will be hereinafter described. A harness 22 is attached to the four corners of the trough ends 12 and the trough sides 13, in order to raise the hopper trough 11 and the feed tube 27, as further hereinafter described. The feed tube 27 is attached to one of the trough sides 12 of the feed hopper 10 and one end of an auger 31, having an auger shaft 18, projects from the tube bore 28 of the feed tube 27 and through the trough end 12 to a hopper bearing 18a, located in the opposite trough bottom 12a, as illustrated in FIG. 1. Accordingly, it will be appreciated that the auger 31 is exposed to the feed 35 and is rotatably disposed within the hopper trough 11 and inside the feed tube 27, in order to cause the feed 35 to flow through the tube bore 28 of the feed tube 27 responsive to rotation of the auger 31, as hereinafter further described. As further illustrated in FIGS. 2, 5 and 8-12 of the drawings, a portion of the feed 35 which is introduced into the tube bore 28 of the feed tube 27 traverses the entire length of the feed tube 27 and is ultimately delivered to the control box 43. Referring now to FIGS. 2, 5 and 8, this quantity of feed 35 is expelled from the tube bore 28 of the feed tube 27 downwardly into the control box feed chamber 61, having a chamber taper 61a, where it is first accumulated and then delivered to the end one of the brooder pans 42, as illustrated in FIG. 5. The control box 43 is further characterized by a box end 48, box sides 45, which span a hinged box top 44 and a box bottom 46, which closes the top of the control box 43 to the point where the control box feed chamber 61 extends downwardly from the control box 43, as illustrated in FIG. 2. The chamber sides 61b and chamber taper 61a define the bottom of the control box 43 and a length of bearing tubing 57 is welded or otherwise secured to a bearing tubing plate 57a, which is bolted or otherwise removably secured to the outside one of the chamber sides 61b in the control box 43, in order to dispose the greater portion of the bearing tubing 57 inside the control box feed chamber 61. A pair of bearings 58 are provided in each end of the bearing tubing 57, one of which bearings 58 supports the extending end of the pulley shaft 17a and the other of which supports the rear internal end of the pulley shaft 17a. The extending end of the feed tube 27 projects through an auger sleeve 60, mounted in the box end 48 of the control box 43 and the corresponding end of the auger 31 is attached to the internally-located end of the pulley shaft 17a by means of a shaft mount bracket 59, as illustrated in FIGS. 2 and 8. As further illustrated in FIGS. 9 and 11 of the drawings, the bearing tubing 57 projects through a tubing opening 56b located in the mount plate 56, which is attached to the chamber sides 61b of the control box 43, by means of plate mount bolts 56a and cooperating mount nuts 51, as illustrated in FIG. 8. The mount plate 56 extends downwardly through the control box feed chamber 61 in fixed relationship, parallel to the box end 48 of the control box 43. The bearing tubing 57 also projects through a generally elliptically-shaped swing plate slot 50b, located in a swing plate 50, which is pivotally carried by the mount plate 56 in swinging relationship, as further illustrated in FIG. 2. Referring to FIGS. 10 and 12 of the drawings, in a preferred embodiment the swing plate 50 is fitted with a curved swing plate tab 50a, which is adapted to engage the top edge 56c of the mount plate 56, in order to facilitate mounting of the swing plate 50 in swinging relationship on the mount plate 56 between the mount plate 56 and the chamber side 61b of the control box feed chamber 61 which receives the bearing tubing plate 57a, as illustrated in FIG. 2. A microswitch 49 is secured to the same chamber side 61b of the control box feed chamber 61 by means of a wing bolt 38 and is fitted with a sensing button 49a disposed in close proximity to the swing plate 50, in order to facilitate activation of the microswitch 49 when the swing plate 50 swings toward the microswitch 49 responsive to the pressure of feed 35 emptying from the auger sleeve 60 into the control box feed chamber 61, as hereinafter further described. A motor 14, having a projecting motor shaft 16, is bolted to the box top 44 as illustrated in FIG. 2. Furthermore, in a most preferred embodiment of the invention, the box top 44 is hinged to the end of the control box 43 by means of a hinge 44a and is further characterized by a pair of latches 44b, each of which includes a latch bracket 44c, secured to the opposite end 48 of the control box 43 and a latch bolt 44d secured by a latch nut 44e when fitted in a slot (not illustrated) provided in the box top 44, in order to maintain the box top 44 in closed configuration and the motor 14 in operational mode, as illustrated in FIG. 2. A motor pulley 15 is keyed to the projecting end of the motor shaft 16 of the motor 14 and is provided in alignment with a control box pulley 17 mounted on the pulley shaft 17a which projects through the bearings 58 of the bearing tubing 57. A belt 26, illustrated in section in FIG. 2, connects the motor pulley 15 and the control box pulley 17, in order to facilitate rotational operation of the auger 31 in the tube bore 28 of the feed tube 27, as hereinafter further described. Accordingly, referring again to FIG. 5 of the drawings, it will be appreciated that when the auger 31 is rotating inside the feed tube 27 responsive to operation of the motor 14, some of the feed 35 located in the hopper trough 11 of the feed hopper 10 is caused to traverse the length of the feed tube 27 and ultimately spill from the extending end of the feed tube 27 into the control box feed chamber 61, as illustrated in FIG. 2. Referring now to FIGS. 2 and 5-7 of the drawings, a portion of the feed 35 which moves through the tube bore 28 of the feed tube 27 by operation of the auger 31 is also distributed to and accumulated in the various line drop tubes 76, which are disposed in spaced relationship on the feed tube 27, as illustrated in FIG. 5. These line drop tubes 76 are each attached to the feed tube 27 by means of a drop tube cap 77, which is bolted to the companion line drop tube 76 by means of cap bolts 78, as illustrated in FIGS. 6 and 7. An opening (not illustrated) provided in the feed tube 27 at each of the line drop tubes 76 allows a quantity of feed 35 to flow from the tube bore 28 into each of the line drop tubes 76. Each of the line drop tubes 76 is generally tubular-shaped, with a downwardly-extending, circular, tapered throat 62 provided at the bottom thereof and a round tube opening 64 defined by the extending end of the tapered throat 62, as further illustrated in FIGS. 6 and 7. A cable pin 67 projects through a diameter of each of the line drop tubes 76 and is removably secured in the line drop tube 76 by means of a cotter pin 79, which projects through a hole in the extending end of the cable pin 67. A cable pin sleeve 67a may be rotatably positioned on the cable pin 67. One end of a valve control cable 68 is secured to the control cable eye 68a extending from the air cylinder 63, which is mounted to the bottom cap 12b of the hopper trough 11 and the opposite end of the valve control cable 68 extends through an opening in the control box feed chamber 61, as illustrated in FIGS. 1 and 2. This latter end of the valve control cable 68 projects around a cable pin sleeve 67a, rotatably mounted on the cable pin 67 and is secured to a valve eye 66, which supports a cone-shaped feed control valve 65, positioned in the round tube opening 64 of the control box feed chamber 61. A spring 74 is provided in the valve control cable 68 and a mount arm 69 extends downwardly from fixed attachment to the valve control cable 68, as further illustrated in FIG. 2. A short mount cable 70 is stretched between the mount arm 69 and a mount cable eye 71, which is secured to the control box feed chamber 61 and a mount cable spring 72 is provided in the mount cable 70, in order to facilitate controlled opening of the tube opening 64 by operation of the cone-shaped feed control valve 65 when spring tension is applied to the valve control cable 68, as hereinafter further described. Referring again to FIGS. 6 and 7 of the drawings, the valve control cable 68 extends beneath the feed tube 27 along the entire length thereof and individual valve cables 73 project from fixed attachment to the valve control cable 68 through openings (not illustrated) in the walls of the respective line drop tubes 76 and around the respective cable pin sleeves 67a of the cable pins 67, to companion cone-shaped feed control valves 65, which are disposed in the round tube openings 64, respectively. A valve cable spring 74 is provided in each of the valve cables 73 near the point of attachment of each valve cable 73 with the cooperating valve control cable 68, in order to facilitate smooth opening of the tube openings 64 by applying tension to the valve control cable 68 and adjusting the position of each feed control valve 65 in the companion tube openings 64, respectively, as hereinafter further described. Referring again to FIGS. 1, 2, 5 and 6 of the drawings, in operation, the air cylinder 63 illustrated in FIG. 1 is energized by a solenoid valve (not illustrated) and can be either manually operated or operated by means of a timer to initially apply tension to the valve control cable 68 in closed configuration and facilitate retraction of the cone-shaped feed control valves 65 into the respective tube openings 64 in the line drop tubes 76 and the control box feed chamber 61. At the same time, the motor 14 is energized by appropriate wiring (not illustrated), to effect rotation of the auger 31 in the tube bore 28 of the feed tube 27, and cause the feed 35 to be transferred from the hopper trough 11 through the feed tube 27 and into the respective line drop tubes 76 and finally, into the control box feed chamber 61. The feed 35 then spills through the respective tube openings 64 to fill the respective line drop tubes 76 and the control box feed chamber 61. When the feed accumulates inside the control box feed chamber 61, this accumulation causes the swing plate 50 to swing rearwardly in the direction of the arrow, as illustrated in FIG. 2 and touch the sensing button 49a in the microswitch 49. The microswitch 49 is electrically connected to the motor 14 and causes the motor 14 to stop operating. The timer continues to operate for a selected period of time which is greater than the time necessary to fill the line drop tubes 76 and control box feed chamber 61. The timer then deenergizes the air cylinder 63 by appropriate wiring (not illustrated) to allow the valve cable springs 74 and the mount cable spring 72 to tension the valve control cable 68, thereby applying tension to the respective valve cables 73 and extending the respective feed control valves 65 from the tube openings 64 of the line drop tubes 76 and the control box feed chamber 61, respectively, and opening the respective tube openings 64. This action prevents allows the feed 35 to flow through the tube openings 64 into the brooder pans 42. Referring now to FIGS. 3 and 4 of the drawings, in a most preferred embodiment of the invention the brooder feeding apparatus 1 of this invention is set up along with a companion brooder feeding apparatus 1 in the centrally-located brooder area 2 of a poultry house 3, as illustrated in FIG. 4. The poultry house 3 is characterized by sides 4, a front 5, a rear 6 and the ground level 7 is illustrated in FIG. 4. Furthermore, multiple brooders 9 are provided between the brooder feeding apparatus 1 for hatching baby poultry, such as baby chicks. Each of the brooder feeding apparatus 1 is characterized by a feed hopper 10, having a hopper trough 11 located at one end thereof and a control box 43 at the other end, which hopper trough 11 and control box 43 are connected by a feed tube 27, as illustrated in FIG. 3. As further illustrated in FIG. 4, in a most preferred embodiment of the invention, a pulley cover 15a is removably disposed over the motor pulley 15 by means of cover bolts 15b and the control box 17 illustrated in FIG. 2, in order to minimize danger from the rotating belt 26. Furthermore, support cables 23 are extended around the feed tube 27 in spaced relationship and one of the support cables 23 is secured to the pulley cover 15a by means of the cover eye bolts 15c, while a companion harness 22 and support cable 23 is attached to the hopper trough 11 of the feed hopper 10, in order to effect lifting of the entire brooder feeding apparatus 1 to a selected distance above the ground level 7. This facility is necessary in order to periodically clean the poultry house 3 and to remove the brooder feeding apparatus 1 from the brooder area 2 when the chicks are sufficiently large to feed from feeding systems located elsewhere in the poultry house 3. While the preferred embodiments of the invention have been described above, it will be recognized and understood that various modifications may be made therein and the appended claims are intended to cover all such modifications which may fall within the spirit and scope of the invention.

1a

RELATED APPLICATION [0001] This application is based on U.S. Provisional Applications Nos. 60/358,830, filed Feb. 22, 2002, and 60/417,747, filed Oct. 10, 2002, the specifications of which are hereby incorporated by reference in their entireties herein. BACKGROUND OF THE INVENTION [0002] The transfer of nucleic acids into a given cell is at the root of gene therapy. However, one of the problems is to succeed in causing a sufficient quantity of nucleic acid to penetrate into cells of the host to be treated. One of the approaches selected in this regard has been the integration of the nucleic acid into viral vectors, in particular into retroviruses, adenoviruses or adeno-associated viruses. These systems take advantage of the cell penetration mechanisms developed by viruses, as well as their protection against degradation. However, this approach has disadvantages, and in particular a risk of production of infectious viral particles capable of dissemination in the host organism, and, in the case of retroviral vectors, a risk of insertional mutagenesis. Furthermore, the capacity for insertion of a therapeutic or vaccinal gene into a viral genome remains limited. [0003] In any case, the development of viral vectors capable of being used in gene therapy requires the use of complex techniques for defective viruses and for complementation cell lines. [0004] Another approach (Wolf et al. Science 247, 1465-68, 1990; Davis et al. Proc. Natl. Acad. Sci. USA 93, 7213-18, 1996) has therefore consisted in administering into the muscle or into the blood stream a nucleic acid of a plasmid nature, combined or otherwise with compounds intended to promote its transfection, such as proteins, liposomes, charged lipids or cationic polymers such as polyethylenimine, which are good transfection agents in vitro (Behr et al. Proc. Natl. Acad. Sci. USA 86, 6982-6, 1989; Felgner et al. Proc. Natl. Acad. Sci. USA 84, 7413-7, 1987; Boussif et al. Proc. Natl. Acad. Sci. USA 92, 7297-301, 1995). [0005] As regards the muscle, since the initial publication by J. A. Wolff et al. showing the capacity of muscle tissue to incorporate DNA injected in free plasmid form (Wolff et al. Science 247, 1465-1468, 1990), numerous authors have tried to improve this procedure (Manthorpe et al., 1993, Human Gene Ther. 4,419-431; Wolff et al., 1991, BioTechniques 11, 474-485). A few trends emerge from these tests, such as in particular: [0006] the use of mechanical solutions to force the entry of DNA into cells by adsorbing the DNA onto beads which are then propelled onto the tissues (“gene gun”) (Sanders Williams et al., 1991, Proc. Natl. Acad. Sci. USA 88, 2726-2730; Fynan et al., 1993, BioTechniques 11, 474-485). These methods have proved effective in vaccination strategies but they affect only the top layers of the tissues. In the case of the muscle, their use would require a surgical approach in order to allow access to the muscle because the particles do not cross the skin tissues; [0007] the injection of DNA, no longer in free plasmid form but combined with molecules capable of serving as vehicle facilitating the entry of the complexes into cells. Cationic lipids, which are used in numerous other transfection methods, have proved up until now disappointing, because those which have been tested have been found to inhibit transfection (Schwartz et al., 1996, Gene Ther. 3, 405-411). The same applies to cationic peptides and polymers (Manthorpe et al., 1993, Human Gene Ther. 4, 419-431). The only case of a favourable combination appears to be the mixing of poly(vinyl alcohol) or polyvinylpyrrolidone with DNA. The increase resulting from these combinations only represents a factor of less than 10 compared with DNA injected in naked form (Mumper et al., 1996, Pharmaceutical Research 13, 701-709); and [0008] the pretreatment of the tissue to be injected with solutions intended to improve the diffusion and/or the stability of DNA (Davis et al., 1993, Hum. Gene Ther. 4, 151-159), or to promote the entry of nucleic acids, for example the induction of cell multiplication or regeneration phenomena. The treatments have involved in particular the use of local anaesthetics or of cardiotoxin, of vasoconstrictors, of endotoxin or of other molecules (Manthorpe et al., 1993, Human Gene Ther. 4, 419-431; Danko et al., 1994, Gene Ther. 1, 114-121; Vitadello et al., 1994, Hum. Gene Ther. 5, 11-18). These pretreatment protocols are difficult to manage, bupivacaine in particular requiring, in order to be effective, being injected at doses very close to lethal doses. The preinjection of hyperosmotic sucrose, intended to improve diffusion, does not increase the transfection level in the muscle (Davis et al., 1993). [0009] Other tissues have been transfected in vivo either using plasmid DNA alone or in combination with synthetic vectors (reviews by Cotten and Wagner (1994), Current Opinion in Biotechnology 4, 705; Gao and Huang (1995), Gene Therapy, 2, 710; Ledley (1995), Human Gene Therapy 6, 1129). The principal tissues studied were the liver, the respiratory epithelium, the wall of the vessels, the central nervous system and tumours. In all these tissues, the levels of expression of the transgenes have proved to be too low to envisage a therapeutic application (for example in the liver, Chao et al. (1996) Human Gene Therapy 7, 901), although some encouraging results have recently been obtained for the transfer of plasmid DNA into the vascular wall (Iires et al. (1996) Human Gene Therapy 7,959 and 989). In the brain, the transfer efficiency is very low, likewise in tumours (Schwartz et al. 1996, Gene Therapy 3, 405; Lu et al. 1994, Cancer Gene Therapy 1, 245; Son et al. Proc. Natl. Acad. Sci. USA 91, 12669). SUMMARY OF THE INVENTION [0010] In certain embodiments, this invention answers the need for improved transfection methods by providing carbohydrate-modified polycationic polymers, such as carbohydrate-modified poly(ethylenimine) (PEI). In certain embodiments, the invention relates to the novel observation that higher levels of carbohydrate modification (i.e., higher average number of carbohydrate moieties per polymer subunit) reduce the toxicity of polycationic polymers such as poly(ethylenimine), while lower levels of carbohydrate modification are generally more compatible with efficient transfection rates. Accordingly, certain embodiments of the invention provide carbohydrate-modified poly(ethylenimine) wherein the degree of carbohydrate modification is selected so as to provide efficient transfection and reduced toxicity to target cells. In further embodiments, the carbohydrate-modified poly(ethylenimine) polymers of the invention have a linear (unbranched) poly(ethylenimine) backbone. In certain preferred embodiments, the invention provides cyclodextrin-modified polycationic polymers, such as cyclodextrin-modified poly(ethylenimine). In certain embodiments, the invention also provides methods of preparing such polymers. In yet additional embodiments, the invention also provides therapeutic compositions containing a therapeutic agent, such as a nucleic acid (e.g., a plasmid or other vector), and a carbohydrate-modified polymer of the invention. Methods of treatment by administering a therapeutically effective amount of a therapeutic composition of the invention are also described. [0011] Carbohydrates that can be used to modify polymers to improve their toxicity profiles include cyclodextrin (CD), allose, altrose, glucose, dextrose, mannose, glycerose, gulose, idose, galactose, talose, fructose, psicose, sorbose, rhamnose, tagatose, ribose, arabinose, xylose, lyxose, ribulose, xylulose, erythrose, threose, erythrulose, fucose, sucrose, lactose, maltose, isomaltose, trehalose, cellobiose and the like. In certain embodiments, the polymer is modified with cyclodextrin moieties and/or galactose moieties. [0012] In one aspect, the invention relates to a kit comprising a carbohydrate polymer, such as a cyclodextrin-modified polyethylenimine (CD-PEI), as described below, optionally in conjunction with a pharmaceutically acceptable excipient, and instructions for combining the polymer with a nucleic acid for use as a transfection system. The instructions may further include instructions for administering the combination to a patient. [0013] In yet another aspect, the invention relates to a method for conducting a pharmaceutical business by manufacturing a polymer or kit as described herein, and marketing to healthcare providers the benefits of using the polymer or kit in the treatment of a medical condition, e.g., for transfecting a patient with a nucleic acid. [0014] In still a further aspect, the invention provides a method for conducting a pharmaceutical business by providing a distribution network for selling a polymer or kit as described herein, and providing instruction material to patients or physicians for using the polymer or kit to treat a medical condition, e.g., for transfecting a patient with a nucleic acid. [0015] Thus, in one aspect, the invention relates to a polymer comprising poly(ethylenimine) (e.g., a polymer comprising at least about 10 or more contiguous ethylenimine monomers, preferably at least 50 or more such monomers) coupled to carbohydrate moieties, such as cyclodextrin moieties. The poly(ethylenimine) may be a branched or a linear polymer. The cyclodextrin moieties may be covalently coupled to the poly(ethylenimine), or may be linked to the poly(ethylenimine) via inclusion complexes (e.g., the polymer is covalently modified with guest moieties, and the cyclodextrin moieties are coupled through formation of inclusion complexes with these moieties). In certain embodiments, at least a portion of the carbohydrate moieties are coupled to the polymer at internal nitrogens (i.e., nitrogen atoms in the backbone of the polymer, as opposed to primary amino groups at termini of the polymer chain). The polymer may have a structure of the formula: [0016] wherein R represents, independently for each occurrence, H, lower alkyl, a moiety including a cyclodextrin moiety, or [0017] m, independently for each occurrence, represents an integer greater than 10. [0018] The ratio of ethylenimine units to cyclodextrin moieties in the polymer may be between about 4:1 and 20:1, or even between about 9:1 and 20:1. [0019] In another aspect, the invention relates to a polymer comprising a structure of the formula: [0020] wherein R represents, independently for each occurrence, H, lower alkyl, a moiety including a carbohydrate moiety, or [0021] m, independently for each occurrence, represents an integer greater than 10. [0022] In certain embodiments, the polymer is a linear polymer (e.g., R represents H, lower alkyl, or a moiety including a carbohydrate moiety). In certain embodiments, about 3-15% of the occurrences of R represent a moiety including a carbohydrate moiety, preferably other than a galactose or mannose moiety. In certain embodiments, the carbohydrate moieties include cyclodextrin moieties, and may even consist essentially of cyclodextrin moieties. In certain embodiments, about 3-25% of the occurrences of R represent a moiety including a cyclodextrin moiety. [0023] In another aspect, the invention relates to a composition comprising a polymer as described above admixed and/or complexed with a nucleic acid. In yet another aspect, the invention relates to a method for transfecting a cell with a nucleic acid, comprising contacting the cell with such a composition. [0024] In still another embodiment, the invention relates to a kit comprising a polymer as set forth above with instructions for combining the polymer with a nucleic acid for transfecting cells with the nucleic acid. [0025] In a further embodiment, the invention relates to a method of conducting a pharmaceutical business, comprising providing a distribution network for selling a kit or polymer as described above, and providing instruction material to patients or physicians for using the polymer to treat a medical condition. [0026] In still another embodiment, the invention relates to a particles comprising a polymer as described above and having a diameter between 50 and 1000 nm. Such particles may further comprise a nucleic acid, and/or may further comprise polyethylene glycol chains coupled to the polymer through inclusion complexes with cyclodextrin moieties coupled to the polymer. BRIEF DESCRIPTION OF THE DRAWINGS [0027] [0027]FIG. 1 demonstrates that AD-PEG (an adamantane-polyethylene glycol conjugate) is able to stabilize the CD-PEI polyplexes against salt-induced aggregation when mixed with the polyplexes at a 3:1 ratio (by weight) to the CD-PEI. Addition of PEG even up to 10:1 ratio (by weight) to CD-PEI does not affect the salt stability of the polyplexes. [0028] [0028]FIG. 2 shows that AD-PEG is able to stabilize the CD-PEI polyplexes against salt-induced aggregation when mixed with the polyplexes at a 20:1 ratio (by weight) to the CD-PEI. Addition of PEG at 20:1 ratio (by weight) to CD-PEI does not affect the salt stability of the polyplexes. [0029] [0029]FIG. 3 compares transfection efficiency of oligonucleotide delivery to cultured cell cells using polymeric delivery vehicles. [0030] [0030]FIG. 4 shows in vitro transfection levels using different CD-PEI carriers. [0031] [0031]FIG. 5 illustrates how the IC 50 of nucleic acids transfected with PEI is increased by over 2 orders of magnitude by heavy grafting of β-cyclodextrin. [0032] [0032]FIG. 6 depicts expression of transfected nucleic acid in mouse liver. [0033] [0033]FIG. 7 presents results of experiments transfecting hepatoma cells with galactose targeted CD-PEI polymer-based particles containing the luciferase gene. [0034] [0034]FIG. 8 shows the correlation between CD-loading and transfection efficiency for CD-bPEI. [0035] [0035]FIG. 9 shows the correlation between CD-loading and toxicity for CD-bPEI. [0036] [0036]FIG. 10 compares the transfection efficiencies of CD-bPEI and CD-1PEI, and the effect chloroquine has on transfection with these polymers. [0037] [0037]FIG. 11 is a photoelectron micrograph of CD-PEI particles. [0038] [0038]FIG. 12 demonstrates stabilization of CD-PEI particles against salt-induced aggregation by particle modification with AD-PEG. [0039] [0039]FIG. 13 demonstrates the effectiveness of transfections using CD-PEI particles. DETAILED DESCRIPTION OF THE INVENTION [0040] I. Overview [0041] Linear and branched poly(ethylenimine)(PEI) are some of the most efficient cationic polymers currently used for in vitro transfections. However, the use of PEI for in vivo applications has been limited due to difficulties in formulation (aggregation in salt) and toxicity of the polymer (Chollet et al. 2001 J of Gene Med ). Approaches for improving the formulation conditions of PEI include grafting of the polymer with poly(ethylene glycol) (PEG) and grafting of polyplexes with PEG (Ogris et al. 1999 Gene Ther 6:595-605; and Erbacher et al. 1999 J Gene Med 1:210-222). However, PEI-PEG does not condense DNA into small, spherical particles, and grafting of polyplexes with PEG is difficult to control and to scale-up. Therefore, current PEI systems for in vivo, systemic delivery have not been promising. [0042] Linear cyclodextrin-based polymers (CDPs) have previously been shown to have low toxicity both in vitro (in many different cell lines) and in vivo (Gonzalez et al. 1999 Bioconjugate Chem 10:1068-1074; and Hwang et al. 2001 Bioconjugate Chem 12(2):280-290). We observed that removal of the cyclodextrins from the polymer backbone results in high toxicity of the cationic polymer. This observation led us to conclude that cyclodextrin is able to reduce the toxicity of cationic polymers. In certain embodiments, the present invention is directed to the development of a new method of using cyclodextrins in cationic, cyclodextrin-based polymers to impart stability and targeting ability to polyplexes formed from these polymers. [0043] Since the current linear CDPs transfect poorly into mammalian cell lines (<2% transfection), cyclodextrin-modified polymers of the invention combine the good qualities of the PEI (efficient chloroquine-independent transfection) with the good qualities of the cyclodextrin-based polymers (low toxicity and ability to modify and stabilize the polyplexes). Therefore, as described below, cyclodextrin-grafted polyethylenimine polymers were synthesized and tested. Accordingly, in certain embodiments, preferred carbohydrate-modified polymers of the invention are cyclodextrin-modified polymers, such as cyclodextrin-modified poly(ethylenimines). [0044] The present invention is generally related to a composition comprising carbohydrate-modified polycationic polymers and nucleic acid. In various embodiments, the nucleic acid may be an expression construct, e.g., including a coding sequence for a protein or antisense, an antisense sequence, an RNAi construct, an siRNA construct, an oligonucleotide, or a decoy, such as for a DNA-binding protein. [0045] In certain embodiments, the present compositions have several advantages over other technologies. Most technologies either have high transfection and high toxicity (PEI, Lipofectamine) or low transfection and low toxicity (linear CDPs, other cationic degradable polymers). However, the polymers disclosed herein, such as CD-PEI, have high transfection and low toxicity in vivo. Galactosylated and mannosylated PEI have also been demonstrated to have high transfection with lower toxicity than unmodified PEI, but these polymers do not have any stabilization ability and is likely to aggregate in vivo. The carbohydrate-modified polymers disclosed herein are readily adaptable for in vivo applications via the inclusion-complex modification technology. This would allow for stabilization and targeting of these polyplexes. In addition, the method of carbohydrate modification described herein can increase the IC 50 by ˜100-fold, whereas the galactose- and mannose-modified PEI's increase IC 50 's only around 10-20 fold. [0046] II. Definitions [0047] For convenience, certain terms employed in the specification, examples, and appended claims are collected here. [0048] The term “ED 50 ” means the dose of a drug that produces 50% of its maximum response or effect. [0049] An “effective amount” of a subject compound, with respect to the subject method of treatment, refers to an amount of the therapeutic in a preparation which, when applied as part of a desired dosage regimen causes a increase in survival of a neuronal cell population according to clinically acceptable standards for the treatment or prophylaxis of a particular disorder. [0050] The term “healthcare providers” refers to individuals or organizations that provide healthcare services to a person, community, etc. Examples of “healthcare providers” include doctors, hospitals, continuing care retirement communities, skilled nursing facilities, subacute care facilities, clinics, multispecialty clinics, freestanding ambulatory centers, home health agencies, and HMO's. [0051] The term ‘IC 50 ’ refers to the concentration of an inhibitor composition that has 50% of the maximal inhibitory effect. Where the inhibitor composition inhibits cell growth, the IC 50 is the concentration that causes 50% of the maximal inhibition of cell growth. [0052] The term “LD 50 ” means the dose of a drug that is lethal in 50% of test subjects. [0053] A “patient” or “subject” to be treated by the subject method are mammals, including humans. [0054] By “prevent degeneration” it is meant reduction in the loss of cells (such as from apoptosis), or reduction in impairment of cell function, e.g., release of dopamine in the case of dopaminergic neurons. Generally, as used herein, a therapeutic that “prevents” a disorder or condition refers to a compound that, in a sample, reduces the occurrence of the disorder or condition in the sample, relative to an untreated control sample, or delays the onset of one or more symptoms of the disorder or condition. [0055] The term “prodrug” is intended to encompass compounds that, under physiological conditions, are converted into the therapeutically active agents of the present invention. A common method for making a prodrug is to include selected moieties that are hydrolyzed under physiological conditions to reveal the desired molecule. In other embodiments, the prodrug is converted by an enzymatic activity of the host animal. [0056] The term “therapeutic index” refers to the therapeutic index of a drug defined as LD 50 /ED 50 . [0057] A “trophic factor” is a molecule that directly or indirectly affects the survival or function of a neuronal cell, e.g., a dopaminergic or GABAergic cell. [0058] A “trophic amount” of a subject compound is an amount sufficient to, under the circumstances, cause an increase in the rate of survival or the functional performance of a neuronal cell, e.g., a dopaminergic or GABAergic cell. [0059] ‘Acyl’ refers to a group suitable for acylating a nitrogen atom to form an amide or carbamate, a carbon atom to form a ketone, a sulfur atom to form a thioester, or an oxygen atom to form an ester group, e.g., a hydrocarbon attached to a —C(═O)— moiety. Preferred acyl groups include benzoyl, acetyl, tert-butyl acetyl, pivaloyl, and trifluoroacetyl. More preferred acyl groups include acetyl and benzoyl. The most preferred acyl group is acetyl. [0060] The term ‘acylamino’ is art-recognized and preferably refers to a moiety that can be represented by the general formula: [0061] wherein R 9 and R′ 11 each independently represent hydrogen or a hydrocarbon substituent, such as alkyl, heteroalkyl, aryl, heteroaryl, carbocyclic aliphatic, and heterocyclic aliphatic. [0062] The terms ‘amine’ and ‘amino’ are art-recognized and refer to both unsubstituted and substituted amines as well as ammonium salts, e.g., as can be represented by the general formula: [0063] wherein R 9 , R 10 , and R′ 10 each independently represent hydrogen or a hydrocarbon substituent, or R 9 and R 10 taken together with the N atom to which they are attached complete a heterocycle having from 4 to 8 atoms in the ring structure. In preferred embodiments, none of R 9 , R 10 , and R′ 10 is acyl, e.g., R 9 , R 10 , and R′ 10 are selected from hydrogen, alkyl, heteroalkyl, aryl, heteroaryl, carbocyclic aliphatic, and heterocyclic aliphatic. The term ‘alkylamine’ as used herein means an amine group, as defined above, having at least one substituted or unsubstituted alkyl attached thereto. Amino groups that are positively charged (e.g., R′ 10 is present) are referred to as ‘ammonium’ groups. In amino groups other than ammonium groups, the amine is preferably basic, e.g., its conjugate acid has a pK a above 7. [0064] The terms ‘amido’ and ‘amide’ are art-recognized as an amino-substituted carbonyl, such as a moiety that can be represented by the general formula: [0065] wherein R 9 and R 10 are as defined above. In certain embodiments, the amide will include imides. [0066] ‘Alkyl’ refers to a saturated or unsaturated hydrocarbon chain having 1 to 18 carbon atoms, preferably 1 to 12, more preferably 1 to 6, more preferably still 1 to 4 carbon atoms. Alkyl chains may be straight (e.g., n-butyl) or branched (e.g., sec-butyl, isobutyl, or t-butyl). Preferred branched alkyls have one or two branches, preferably one branch. Preferred alkyls are saturated. Unsaturated alkyls have one or more double bonds and/or one or more triple bonds. Preferred unsaturated alkyls have one or two double bonds or one triple bond, more preferably one double bond. Alkyl chains may be unsubstituted or substituted with from 1 to 4 substituents. Preferred alkyls are unsubstituted. Preferred substituted alkyls are mono-, di-, or trisubstituted. Preferred alkyl substituents include halo, haloalkyl, hydroxy, aryl (e.g., phenyl, tolyl, alkoxyphenyl, alkyloxycarbonylphenyl, halophenyl), heterocyclyl, and heteroaryl. [0067] The terms ‘alkenyl’ and ‘alkynyl’ refer to unsaturated aliphatic groups analogous in length and possible substitution to the alkyls described above, but that contain at least one double or triple bond, respectively. When not otherwise indicated, the terms alkenyl and alkynyl preferably refer to lower alkenyl and lower alkynyl groups, respectively. When the term alkyl is present in a list with the terms alkenyl and alkynyl, the term alkyl refers to saturated alkyls exclusive of alkenyls and alkynyls. [0068] The terms ‘alkoxyl’ and ‘alkoxy’ as used herein refer to an —O-alkyl group. Representative alkoxyl groups include methoxy, ethoxy, propyloxy, tert-butoxy, and the like. An ‘ether’ is two hydrocarbons covalently linked by an oxygen. Accordingly, the substituent of a hydrocarbon that renders that hydrocarbon an ether can be an alkoxyl, or another moiety such as —O-aryl, —O-heteroaryl, —O-heteroalkyl, —O-aralkyl, —O-heteroaralkyl, —O-carbocylic aliphatic, or —O-heterocyclic aliphatic. [0069] The term ‘alkylthio’ refers to an —S-alkyl group. Representative alkylthio groups include methylthio, ethylthio, and the like. ‘Thioether’ refers to a sulfur atom bound to two hydrocarbon substituents, e.g., an ether wherein the oxygen is replaced by sulfur. Thus, a thioether substituent on a carbon atom refers to a hydrocarbon-substituted sulfur atom substituent, such as alkylthio or arylthio, etc. [0070] The term ‘aralkyl’, as used herein, refers to an alkyl group substituted with an aryl group. [0071] ‘Aryl ring’ refers to an aromatic hydrocarbon ring system. Aromatic rings are monocyclic or fused bicyclic ring systems, such as phenyl, naphthyl, etc. Monocyclic aromatic rings contain from about 5 to about 10 carbon atoms, preferably from 5 to 7 carbon atoms, and most preferably from 5 to 6 carbon atoms in the ring. Bicyclic aromatic rings contain from 8 to 12 carbon atoms, preferably 9 or 10 carbon atoms in the ring. The term ‘aryl’ also includes bicyclic ring systems wherein only one of the rings is aromatic, e.g., the other ring is cycloalkyl, cycloalkenyl, or heterocyclyl. Aromatic rings may be unsubstituted or substituted with from 1 to about 5 substituents on the ring. Preferred aromatic ring substituents include: halo, cyano, lower alkyl, heteroalkyl, haloalkyl, phenyl, phenoxy, or any combination thereof. More preferred substituents include lower alkyl, cyano, halo, and haloalkyl. [0072] ‘Carbocyclic aliphatic ring’ refers to a saturated or unsaturated hydrocarbon ring. Carbocyclic aliphatic rings are not aromatic. Carbocyclic aliphatic rings are monocyclic, or are fused, spiro, or bridged bicyclic ring systems. Monocyclic carbocyclic aliphatic rings contain from about 4 to about 10 carbon atoms, preferably from 4 to 7 carbon atoms, and most preferably from 5 to 6 carbon atoms in the ring. Bicyclic carbocyclic aliphatic rings contain from 8 to 12 carbon atoms, preferably from 9 to 10 carbon atoms in the ring. Carbocyclic aliphatic rings may be unsubstituted or substituted with from 1 to 4 substituents on the ring. Preferred carbocyclic aliphatic ring substituents include halo, cyano, alkyl, heteroalkyl, haloalkyl, phenyl, phenoxy or any combination thereof. More preferred substituents include halo and haloalkyl. Preferred carbocyclic aliphatic rings include cyclopentyl, cyclohexyl, cyclohexenyl, cycloheptyl, and cyclooctyl. More preferred carbocyclic aliphatic rings include cyclohexyl, cycloheptyl, and cyclooctyl. [0073] A ‘carbohydrate-modified polymer’ is a polymer that is covalently or associatively (i.e., through an inclusion complex) linked to one or more carbohydrate moieties. [0074] The term ‘carbohydrate moiety’ is intended to include any molecule that is considered a carbohydrate by one of skill in the art and that is covalently bonded to a polymer. Carbohydrate moieties include mono- and polysaccharides. Carbohydrate moieties include trioses, tetroses, pentoses, hexoses, heptoses and monosaccharides of higher molecular weight (either D or L form), as well as polysaccharides comprising a single type of monosaccharide or a mixture of different monosaccharides. Polysaccharides may be of any polymeric conformation (e.g. branched, linear or circular). Examples of monosaccharides include glucose, fructose, and glucopyranose. Examples of polysaccharides include sucrose, lactose and cyclodextrin. [0075] The term ‘carbonyl’ is art-recognized and includes such moieties as can be represented by the general formula: [0076] wherein X is a bond or represents an oxygen or a sulfur, and R 11 represents a hydrogen, hydrocarbon substituent, or a pharmaceutically acceptable salt, R 11′ represents a hydrogen or hydrocarbon substituent. Where X is an oxygen and R 11 or R 11′ is not hydrogen, the formula represents an ‘ester’. Where X is an oxygen, and R 11 is as defined above, the moiety is referred to herein as a carboxyl group, and particularly when R 11 is a hydrogen, the formula represents a ‘carboxylic acid’. Where X is an oxygen, and R 11′ is hydrogen, the formula represents a ‘formate’. In general, where the oxygen atom of the above formula is replaced by sulfur, the formula represents a ‘thiocarbonyl’ group. Where X is a sulfur and R 11 or R 11′ is not hydrogen, the formula represents a ‘thioester.’ Where X is a sulfur and R 11 is hydrogen, the formula represents a ‘thiocarboxylic acid.’ Where X is a sulfur and R 11′ 0 is hydrogen, the formula represents a ‘thioformate.’ On the other hand, where X is a bond, R 11 is not hydrogen, and the carbonyl is bound to a hydrocarbon, the above formula represents a ‘ketone’ group. Where X is a bond, R 11 is hydrogen, and the carbonyl is bound to a hydrocarbon, the above formula represents an ‘aldehyde’ or ‘formyl’ group. [0077] ‘Ci alkyl’ is an alkyl chain having i member atoms. For example, C4 alkyls contain four carbon member atoms. C4 alkyls containing may be saturated or unsaturated with one or two double bonds (cis or trans) or one triple bond. Preferred C4 alkyls are saturated. Preferred unsaturated C4 alkyl have one double bond. C4 alkyl may be unsubstituted or substituted with one or two substituents. Preferred substituents include lower alkyl, lower heteroalkyl, cyano, halo, and haloalkyl. [0078] ‘Halogen’ refers to fluoro, chloro, bromo, or iodo substituents. Preferred halo are fluoro, chloro and bromo; more preferred are chloro and fluoro. [0079] ‘Haloalkyl’ refers to a straight, branched, or cyclic hydrocarbon substituted with one or more halo substituents. Preferred haloalkyl are C1-C12; more preferred are C1-C6; more preferred still are C1-C3. Preferred halo substituents are fluoro and chloro. The most preferred haloalkyl is trifluoromethyl. [0080] ‘Heteroalkyl’ is a saturated or unsaturated chain of carbon atoms and at least one heteroatom, wherein no two heteroatoms are adjacent. Heteroalkyl chains contain from 1 to 18 member atoms (carbon and heteroatoms) in the chain, preferably 1 to 12, more preferably 1 to 6, more preferably still 1 to 4. Heteroalkyl chains may be straight or branched. Preferred branched heteroalkyl have one or two branches, preferably one branch. Preferred heteroalkyl are saturated. Unsaturated heteroalkyl have one or more double bonds and/or one or more triple bonds. Preferred unsaturated heteroalkyl have one or two double bonds or one triple bond, more preferably one double bond. Heteroalkyl chains may be unsubstituted or substituted with from 1 to about 4 substituents unless otherwise specified. Preferred heteroalkyl are unsubstituted. Preferred heteroalkyl substituents include halo, aryl (e.g., phenyl, tolyl, alkoxyphenyl, alkoxycarbonylphenyl, halophenyl), heterocyclyl, heteroaryl. For example, alkyl chains substituted with the following substituents are heteroalkyl: alkoxy (e.g., methoxy, ethoxy, propoxy, butoxy, pentoxy), aryloxy (e.g., phenoxy, chlorophenoxy, tolyloxy, methoxyphenoxy, benzyloxy, alkoxycarbonylphenoxy, acyloxyphenoxy), acyloxy (e.g., propionyloxy, benzoyloxy, acetoxy), carbamoyloxy, carboxy, mercapto, alkylthio, acylthio, arylthio (e.g., phenylthio, chlorophenylthio, alkylphenylthio, alkoxyphenylthio, benzylthio, alkoxycarbonylphenylthio), amino (e.g., amino, mono- and di-C1-C3 alkylamino, methylphenylamino, methylbenzylamino, C1-C3 alkylamido, carbamamido, ureido, guanidino). [0081] ‘Heteroatom’ refers to a multivalent non-carbon atom, such as a boron, phosphorous, silicon, nitrogen, sulfur, or oxygen atom, preferably a nitrogen, sulfur, or oxygen atom. Groups containing more than one heteroatom may contain different heteroatoms. [0082] ‘Heteroaryl ring’ refers to an aromatic ring system containing carbon and from 1 to about 4 heteroatoms in the ring. Heteroaromatic rings are monocyclic or fused bicyclic ring systems. Monocyclic heteroaromatic rings contain from about 5 to about 10 member atoms (carbon and heteroatoms), preferably from 5 to 7, and most preferably from 5 to 6 in the ring. Bicyclic heteroaromatic rings contain from 8 to 12 member atoms, preferably 9 or 10 member atoms in the ring. The term ‘heteroaryl’ also includes bicyclic ring systems wherein only one of the rings is aromatic, e.g., the other ring is cycloalkyl, cycloalkenyl, or heterocyclyl. Heteroaromatic rings may be unsubstituted or substituted with from 1 to about 4 substituents on the ring. Preferred heteroaromatic ring substituents include halo, cyano, lower alkyl, heteroalkyl, haloalkyl, phenyl, phenoxy or any combination thereof. Preferred heteroaromatic rings include thienyl, thiazolyl, oxazolyl, pyrrolyl, purinyl, pyrimidyl, pyridyl, and furanyl. More preferred heteroaromatic rings include thienyl, furanyl, and pyridyl. [0083] ‘Heterocyclic aliphatic ring’ is a non-aromatic saturated or unsaturated ring containing carbon and from 1 to about 4 heteroatoms in the ring, wherein no two heteroatoms are adjacent in the ring and preferably no carbon in the ring attached to a heteroatom also has a hydroxyl, amino, or thiol group attached to it. Heterocyclic aliphatic rings are monocyclic, or are fused or bridged bicyclic ring systems. Monocyclic heterocyclic aliphatic rings contain from about 4 to about 10 member atoms (carbon and heteroatoms), preferably from 4 to 7, and most preferably from 5 to 6 member atoms in the ring. Bicyclic heterocyclic aliphatic rings contain from 8 to 12 member atoms, preferably 9 or 10 member atoms in the ring. Heterocyclic aliphatic rings may be unsubstituted or substituted with from 1 to about 4 substituents on the ring. Preferred heterocyclic aliphatic ring substituents include halo, cyano, lower alkyl, heteroalkyl, haloalkyl, phenyl, phenoxy or any combination thereof. More preferred substituents include halo and haloalkyl. Heterocyclyl groups include, for example, thiophene, thianthrene, furan, pyran, isobenzofuran, chromene, xanthene, phenoxathin, pyrrole, imidazole, pyrazole, isothiazole, isoxazole, pyridine, pyrazine, pyrimidine, pyridazine, indolizine, isoindole, indole, indazole, purine, quinolizine, isoquinoline, hydantoin, oxazoline, imidazolinetrione, triazolinone, quinoline, phthalazine, naphthyridine, quinoxaline, quinazoline, quinoline, pteridine, carbazole, carboline, phenanthridine, acridine, phenanthroline, phenazine, phenarsazine, phenothiazine, furazan, phenoxazine, pyrrolidine, oxolane, thiolane, oxazole, piperidine, piperazine, morpholine, lactones, lactams such as azetidinones and pyrrolidinones, sultams, sultones, and the like. Preferred heterocyclic aliphatic rings include piperazyl, morpholinyl, tetrahydrofuranyl, tetrahydropyranyl and piperidyl. Heterocycles can also be polycycles. [0084] The term ‘hydroxyl’ means —OH. [0085] ‘Lower alkyl’ refers to an alkyl chain comprised of 1 to 5, preferably 1 to 4 carbon member atoms, more preferably 1 or 2 carbon member atoms. Lower alkyls may be saturated or unsaturated. Preferred lower alkyls are saturated. Lower alkyls may be unsubstituted or substituted with one or about two substituents. Preferred substituents on lower alkyl include cyano, halo, trifluoromethyl, amino, and hydroxyl. Throughout the application, preferred alkyl groups are lower alkyls. In preferred embodiments, a substituent designated herein as alkyl is a lower alkyl. Likewise, ‘lower alkenyl’ and ‘lower alkynyl’ have similar chain lengths. [0086] ‘Lower heteroalkyl’ refers to a heteroalkyl chain comprised of 1 to 4, preferably 1 to 3 member atoms, more preferably 1 to 2 member atoms. Lower heteroalkyl contain one or two non-adjacent heteroatom member atoms. Preferred lower heteroalkyl contain one heteroatom member atom. Lower heteroalkyl may be saturated or unsaturated. Preferred lower heteroalkyl are saturated. Lower heteroalkyl may be unsubstituted or substituted with one or about two substituents. Preferred substituents on lower heteroalkyl include cyano, halo, trifluoromethyl, and hydroxyl. [0087] ‘Mi heteroalkyl’ is a heteroalkyl chain having i member atoms. For example, M4 heteroalkyls contain one or two non-adjacent heteroatom member atoms. M4 heteroalkyls containing 1 heteroatom member atom may be saturated or unsaturated with one double bond (cis or trans) or one triple bond. Preferred M4 heteroalkyl containing 2 heteroatom member atoms are saturated. Preferred unsaturated M4 heteroalkyl have one double bond. M4 heteroalkyl may be unsubstituted or substituted with one or two substituents. Preferred substituents include lower alkyl, lower heteroalkyl, cyano, halo, and haloalkyl. [0088] ‘Member atom’ refers to a polyvalent atom (e.g., C, O, N, or S atom) in a chain or ring system that constitutes a part of the chain or ring. For example, in cresol, six carbon atoms are member atoms of the ring and the oxygen atom and the carbon atom of the methyl substituent are not member atoms of the ring. [0089] As used herein, the term ‘nitro’ means —NO 2 . [0090] ‘Pharmaceutically acceptable salt’ refers to a cationic salt formed at any acidic (e.g., hydroxamic or carboxylic acid) group, or an anionic salt formed at any basic (e.g., amino or guanidino) group. Such salts are well known in the art. See e.g., World Patent Publication 87/05297, Johnston et al., published Sep. 11, 1987, incorporated herein by reference. Such salts are made by methods known to one of ordinary skill in the art. It is recognized that the skilled artisan may prefer one salt over another for improved solubility, stability, formulation ease, price and the like. Determination and optimization of such salts is within the purview of the skilled artisan's practice. Preferred cations include the alkali metals (such as sodium and potassium), and alkaline earth metals (such as magnesium and calcium) and organic cations, such as trimethylammonium, tetrabutylammonium, etc. Preferred anions include halides (such as chloride), sulfonates, carboxylates, phosphates, and the like. Clearly contemplated in such salts are addition salts that may provide an optical center where once there was none. For example, a chiral tartrate salt may be prepared from the compounds of the invention. This definition includes such chiral salts. [0091] ‘Phenyl’ is a six-membered monocyclic aromatic ring that may or may not be substituted with from 1 to 5 substituents. The substituents may be located at the ortho, meta or para position on the phenyl ring, or any combination thereof. Preferred phenyl substituents include: halo, cyano, lower alkyl, heteroalkyl, haloalkyl, phenyl, phenoxy or any combination thereof. More preferred substituents on the phenyl ring include halo and haloalkyl. The most preferred substituent is halo. [0092] The terms ‘polycyclyl’ and ‘polycyclic group’ refer to two or more rings (e.g., cycloalkyls, cycloalkenyls, heteroaryls, aryls and/or heterocyclyls) in which two or more member atoms of one ring are member atoms of a second ring. Rings that are joined through non-adjacent atoms are termed ‘bridged’ rings, and rings that are joined through adjacent atoms are ‘fused rings’. [0093] The term ‘sulthydryl’ means —SH, and the term ‘sulfonyl’ means —SO 2 —. [0094] A ‘substitution’ or ‘substituent’ on a small organic molecule generally refers to a position on a multi-valent atom bound to a moiety other than hydrogen, e.g., a position on a chain or ring exclusive of the member atoms of the chain or ring. Such moieties include those defined herein and others as are known in the art, for example, halogen, alkyl, alkenyl, alkynyl, azide, haloalkyl, hydroxyl, carbonyl (such as carboxyl, alkoxycarbonyl, formyl, ketone, or acyl), thiocarbonyl (such as thioester, thioacetate, or thioformate), alkoxyl, phosphoryl, phosphonate, phosphinate, amine, amide, amidine, imine, cyano, nitro, azido, sulthydryl, alkylthio, sulfate, sulfonate, sulfamoyl, sulfonamido, sulfonyl, silyl, ether, cycloalkyl, heterocyclyl, heteroalkyl, heteroalkenyl, and heteroalkynyl, heteroaralkyl, aralkyl, aryl or heteroaryl. It will be understood by those skilled in the art that certain substituents, such as aryl, heteroaryl, polycyclyl, alkoxy, alkylamino, alkyl, cycloalkyl, heterocyclyl, alkenyl, alkynyl, heteroalkyl, heteroalkenyl, and heteroalkynyl, can themselves be substituted, if appropriate. This invention is not intended to be limited in any manner by the permissible substituents of organic compounds. It will be understood that ‘substitution’ or ‘substituted with’ includes the implicit proviso that such substitution is in accordance with permitted valence of the substituted atom and the substituent, and that the substitution results in a stable compound, e.g., which does not spontaneously undergo transformation such as by rearrangement, cyclization, elimination, hydrolysis, etc. [0095] As used herein, the definition of each expression, e.g., alkyl, m, n, etc., when it occurs more than once in any structure, is intended to be independent of its definition elsewhere in the same structure. [0096] The abbreviations Me, Et, Ph, Tf, Nf, Ts, and Ms represent methyl, ethyl, phenyl, trifluoromethanesulfonyl, nonafluorobutanesulfonyl, p-toluenesulfonyl, and methanesulfonyl, respectively. A more comprehensive list of the abbreviations utilized by organic chemists of ordinary skill in the art appears in the first issue of each volume of the Journal of Organic Chemistry ; this list is typically presented in a table entitled Standard List of Abbreviations. The abbreviations contained in said list, and all abbreviations utilized by organic chemists of ordinary skill in the art are hereby incorporated by reference. [0097] The terms ortho, meta and para apply to 1,2-, 1,3- and 1,4-disubstituted benzenes, respectively. For example, the names 1,2-dimethylbenzene and ortho-dimethylbenzene are synonymous. [0098] The phrase ‘protecting group’ as used herein means temporary substituents that protect a potentially reactive functional group from undesired chemical transformations. Examples of such protecting groups include esters of carboxylic acids, silyl ethers of alcohols, and acetals and ketals of aldehydes and ketones, respectively. The field of protecting group chemistry has been reviewed (Greene, T. W.; Wuts, P. G. M. Protective Groups in Organic Synthesis , 2 nd ed.; Wiley: New York, 1991; and Kocienski, P. J. Protecting Groups , Georg Thieme Verlag: New York, 1994). [0099] For purposes of this invention, the chemical elements are identified in accordance with the Periodic Table of the Elements, CAS version, Handbook of Chemistry and Physics, 67th Ed., 1986-87, inside cover. Also for purposes of this invention, the term ‘hydrocarbon’ is contemplated to include all permissible compounds or moieties having at least one carbon-hydrogen bond. In a broad aspect, the permissible hydrocarbons include acyclic and cyclic, branched and unbranched, carbocyclic and heterocyclic, aromatic and nonaromatic organic compounds which can be substituted or unsubstituted. [0100] Contemplated equivalents of the compounds described above include compounds which otherwise correspond thereto, and which have the same useful properties thereof, wherein one or more simple variations of substituents are made which do not adversely affect the efficacy of the compound. In general, the compounds of the present invention may be prepared by the methods illustrated in the general reaction schemes as, for example, described below, or by modifications thereof, using readily available starting materials, reagents and conventional synthesis procedures. In these reactions, it is also possible to make use of variants that are in themselves known, but are not mentioned here. [0101] III. Exemplary Polymer Compositions [0102] The subject polymers include linear and/or branched poly(ethylenimine) polymers that have been modified by attaching carbohydrate moieties, such as cyclodextrin, to the polymer backbone (e.g., through attachment to nitrogen atoms in the polymer chain). The polymers (prior to carbohydrate modification) preferably have molecular weights of at least 2,000, such as 2,000 to 100,000, preferably 5,000 to 80,000. In certain embodiments, the subject polymers have a structure of the formula: [0103] wherein R represents, independently for each occurrence, H, lower alkyl, a carbohydrate moiety (optionally attached via a linker moiety, such as an alkylene chain or a polyethylene glycol oligomer), or [0104] m, independently for each occurrence, represents an integer greater than 10, e.g., from 10-10,000, preferably from 10 to 5,000, or from 100 to 1,000. [0105] In certain embodiments, R includes a carbohydrate moiety for at least about 1%, more preferably at least about 2%, or at least about 3%, and up to about 5% or even 10%, 15%, or 20% of its occurrences. [0106] In certain embodiments, the polymer is linear, i.e., no occurrence of R represents [0107] In certain embodiments, the carbohydrate moieties make up at least about 2%, 3% or 4% by weight, up to 5%, 7%, or even 10% of the carbohydrate-modified polymer by weight. Where the carbohydrate moieties include cyclodextrin, carbohydrate moieties may be 2% of the weight of the copolymer, preferably at least 5% or 10%, or even as much as 20%, 40%, 50%, 60%, 80%, or even 90% of the weight of the copolymer. [0108] In certain embodiments, at least about 2%, 3% or 4%, up to 5%, 7%, or even 10%, 15%, 20%, or 25% of the ethylenimine subunits in the polymer are modified with a carbohydrate moiety. In certain such embodiments, however, no more than 25%, 30%, 35%, 40%, or 50% of the ethylenimine subunits are so modified. In preferred embodiments, the level of carbohydrate modification is selected such that the toxicity is less than 20% of the toxicity of the unmodified polymer, yet the transfection efficiency is at least 30% of the efficiency of the corresponding polymer modified at 5% of the ethylenimine subunits. Preferably, one out of every 6 to 15 ethylenimine subunits is modified with a carbohydrate moiety. [0109] Copolymers of poly(ethylenimine) that bear nucleophilic amino substituents susceptible to derivatization with cyclodextrin moieties can also be used to prepare cyclodextrin-modified polymers within the scope of the present invention. Exemplary extents of carbohydrate modification are 10-15% of the ethyleneimine moieties, 15-20% of the ethylenimine moieties, 20-25% of the ethylenimine moieties, 25-30% of the ethylenimine moieties, 30-40% of the ethylenimine moieties, or a combination of two or more of these ranges. [0110] Where the carbohydrate moiety is attached through a linker, the linker group(s) may be an alkylene chain, a polyethylene glycol (PEG) chain, polysuccinic anhydride, polysebacic acid (PSA), poly-L-glutamic acid, poly(ethyleneimine), an oligosaccharide, an amino acid chain, or any other suitable linkage. More than one type of linker may be present in a given polymer or polymerization reaction. In certain embodiments, the linker group itself can be stable under physiological conditions, such as an alkylene chain, or it can be cleavable under physiological conditions, such as by an enzyme (e.g., the linkage contains a peptide sequence that is a substrate for a peptidase), or by hydrolysis (e.g., the linkage contains a hydrolyzable group, such as an ester or thioester). The linker groups can be biologically inactive, such as a PEG, polyglycolic acid, or polylactic acid chain, or can be biologically active, such as an oligo- or polypeptide that, when cleaved from the moieties, binds a receptor, deactivates an enzyme, etc. Various oligomeric linker groups that are biologically compatible and/or bioerodible are known in the art, and the selection of the linkage may influence the ultimate properties of the material, such as whether it is durable when implanted, whether it gradually deforms or shrinks after implantation, or whether it gradually degrades and is absorbed by the body. The linker group may be attached to the moieties (e.g., the polymer chain and the carbohydrate) by any suitable bond or functional group, including carbon-carbon bonds, esters, ethers, amides, amines, carbonates, carbamates, ureas, sulfonamides, etc. [0111] In certain embodiments the linker group(s) of the present invention represent a hydrocarbylene group wherein one or more methylene groups is optionally replaced by a group Y (provided that none of the Y groups are adjacent to each other), wherein each Y, independently for each occurrence, is selected from, substituted or unsubstituted aryl, heteroaryl, cycloalkyl, heterocycloalky, or —O—, C(═X) (wherein X is NR 1 , O or S), —OC(O)—, —C(═O)O, —NR 1 —, —NR 1 CO—, —C(O)NR 1 —, —S(O) n — (wherein n is 0, 1, or 2), —OC(O)—NR 1 , —NR 1 —C(O)—NR 1 —, —NR 1 —C(═NR 1 )—NR 1 —, and —B(OR 1 )—; and R 1 , independently for each occurrence, represents H or a lower alkyl. [0112] In certain embodiments the linker group represents a derivatized or non-derivatized amino acid. In certain embodiments linking groups with one or more terminal carboxyl groups may be conjugated to the polymer. In certain embodiments, one or more of these terminal carboxyl groups may be capped by covalently attaching them to a therapeutic agent or a cyclodextrin moiety via an (thio)ester or amide bond. In still other embodiments linking groups with one or more terminal hydroxyl, thiol, or amino groups may be incorporated into the polymer. In preferred embodiments, one or more of these terminal hydroxyl groups may be capped by covalently attaching them to a therapeutic agents or a carbohydrate (e.g., cyclodextrin) moiety via a carbonate, carbamate, thiocarbonate, or thiocarbamate bond. In certain embodiments, these (thio)ester, amide, (thio)carbonate or (thio)carbamate bonds may be biohydrolyzable, i.e., capable of being hydrolyzed under biological conditions. [0113] In certain embodiments, carbohydrate moieties can be attached to the polymer via a non-covalent associative interaction. For example, the polymer chain can be modified with groups, such as adamantyl groups, that form inclusion complexes with cyclodextrin. The modified polymer can then be combined with compound that includes a cyclodextrin moiety and, optionally, a carbohydrate moiety (which may be a second cyclodextrin moiety, e.g., the compound may be symmetrical) under conditions suitable for forming inclusion complexes between the polymer and the compound, resulting in a complex such as polymer-adamantane::cyclodextrin-linker-carbohydrate. In this way, a polymer can be modified with carbohydrates without covalently attaching carbohydrates to the polymer itself. Similarly, a cyclodextrin-modified polymer as described herein can be treated with molecule having polyethylene glycol (PEG) chains linked to groups that form inclusion complexes with cyclodextrin. As described in greater detail below, particles of polymers modified in this way are stabilized (e.g., due to the presence of a PEG “brush layer” on their surface) relative to particles in which no such inclusion complexes have been formed. Alternatively or additionally, inclusion complexes can be used to couple ligands to the polymer (e.g., for targeting the polymer to a particular tissue, organ, or other region of a patient's body), or to otherwise modify the physical, chemical, or biological properties of the polymer. [0114] Exemplary cyclodextrin moieties include cyclic structures consisting essentially of from 6 to 8 saccharide moieties, such as cyclodextrin and oxidized cyclodextrin. A cyclodextrin moiety optionally comprises a linker moiety that forms a covalent linkage between the cyclic structure and the polymer backbone, preferably having from 1 to 20 atoms in the chain, such as alkyl chains, including dicarboxylic acid derivatives (such as glutaric acid derivatives, succinic acid derivatives, and the like), and heteroalkyl chains, such as oligoethylene glycol chains. Cyclodextrin moieties may further include one or more carbohydrate moieties, preferably simple carbohydrate moieties such as galactose, attached to the cyclic core, either directly (i.e., via a carbohydrate linkage) or through a linker group. [0115] Cyclodextrins are cyclic polysaccharides containing naturally occurring D-(+)-glucopyranose units in an α-(1,4) linkage. The most common cyclodextrins are alpha ((α)-cyclodextrins, beta (β)-cyclodextrins and gamma (γ)-cyclodextrins which contain, respectively. six, seven, or eight glucopyranose units. Structurally, the cyclic nature of a cyclodextrin forms a torus or donut-like shape having an inner apolar or hydrophobic cavity, the secondary hydroxyl groups situated on one side of the cyclodextrin torus and the primary hydroxyl groups situated on the other. Thus, using (β)-cyclodextrin as an example, a cyclodextrin is often represented schematically as follows. [0116] The side on which the secondary hydroxyl groups are located has a wider diameter than the side on which the primary hydroxyl groups are located. The hydrophobic nature of the cyclodextrin inner cavity allows for the inclusion of a variety of compounds. (Comprehensive Supramolecular Chemistry, Volume 3, J. L. Atwood et al., eds., Pergamon Press (1996); T. Cserhati, Analytical Biochemistry, 225:328-332(1995); Husain et al., Applied Spectroscopy, 46:652-658 (1992); FR 2 665 169). Additional methods for modifying polymers are disclosed in Suh, J. and Noh, Y., Bioorg. Med. Chem. Lett . 1998, 8, 1327-1330. [0117] Cyclodextrins have been used as a delivery vehicle of various therapeutic compounds by forming inclusion complexes with various drugs that can fit into the hydrophobic cavity of the cyclodextrin or by forming non-covalent association complexes with other biologically active molecules such as oligonucleotides and derivatives thereof. For example, see U.S. Pat. Nos. 4,727,064, 5,608,015, 5,276,088, and 5,691,316. Various cyclodextrin-containing polymers and methods of their preparation are also known in the art. Comprehensive Supramolecular Chemistry , Volume 3, J. L. Atwood et al., eds., Pergamon Press (1996). [0118] IV Exemplary Applications of Method and Compositions [0119] Therapeutic compositions according to the invention contain a therapeutic agent and a carbohydrate-modified polymer of the invention, such as, for example, a cyclodextrin-modified polymer of the invention or a carbohydrate-modified polymer having an IC 50 for cells in culture of greater than 25 μg/ml. The therapeutic agent may be any synthetic or naturally occurring biologically active therapeutic agent including those known in the art. Examples of suitable therapeutic agents include, but are not limited to, antibiotics, steroids, polynucleotides (e.g., genomic DNA, cDNA, mRNA and antisense oligonucleotides), plasmids, peptides, peptide fragments, small molecules (e.g., doxorubicin) and other biologically active macromolecules such as, for example, proteins and enzymes. Therapeutic compositions are preferably sterile and/or non-pyrogenic, e.g., do not substantially raise a patient's body temperature after administration. [0120] A therapeutic composition of the invention may be prepared by means known in the art. In a preferred embodiment, a copolymer of the invention is mixed with a therapeutic agent, as described above, and allowed to self-assemble. According to the invention, the therapeutic agent and a carbohydrate-modified polymer of the invention associate with one another such that the copolymer acts as a delivery vehicle for the therapeutic agent. The therapeutic agent and carbohydrate-modified polymer may associate by means recognized by those of skill in the art such as, for example, electrostatic interaction and hydrophobic interaction. The degree of association may be determined by techniques known in the art including, for example, fluorescence studies, DNA mobility studies, light scattering, electron microscopy, and will vary depending upon the therapeutic agent. As a mode of delivery, for example, a therapeutic composition of the invention containing a copolymer of the invention and DNA may be used to aid in transfection, i.e., the uptake of DNA into an animal (e.g., human) cell. (Boussif, O. Proceedings of the National Academy of Sciences, 92:7297-7301(1995); Zanta et al. Bioconjugate Chemistry, 8:839-844 (1997)). [0121] A therapeutic composition of the invention may be, for example, a solid, liquid, suspension, or emulsion. Preferably a therapeutic composition of the invention is in a form that can be injected, e.g., intratumorally or intravenously. Other modes of administration of a therapeutic composition of the invention include, depending on the state of the therapeutic composition, methods known in the art such as, but not limited to, oral administration, topical application, parenteral, intravenous, intranasal, intraocular, intracranial or intraperitoneal injection. [0122] Depending upon the type of therapeutic agent used, a therapeutic composition of the invention may be used in a variety of therapeutic methods (e.g. DNA vaccines, antibiotics, antiviral agents) for the treatment of inherited or acquired disorders such as, for example, cystic fibrosis, Gaucher's disease, muscular dystrophy, AIDS, cancers (e.g., multiple myeloma, leukemia, melanoma, and ovarian carcinoma), cardiovascular conditions (e.g., progressive heart failure, restenosis, and hemophilia), and neurological conditions (e.g., brain trauma). [0123] In certain embodiments according to the invention, a method of treatment administers a therapeutically effective amount of a therapeutic composition of the invention. A therapeutically effective amount, as recognized by those of skill in the art, will be determined on a case by case basis. Factors to be considered include, but are not limited to, the disorder to be treated and the physical characteristics of the one suffering from the disorder. [0124] Another embodiment of the invention is a composition containing at least one biologically active compound having agricultural utility and a linear cyclodextrin-modified polymer or a linear oxidized cyclodextrin-modified polymer of the invention. The agriculturally biologically active compounds include those known in the art. For example, suitable agriculturally biologically active compounds include, but are not limited to, fungicides, herbicides, insecticides, and mildewcides. [0125] Exemplification [0126] The invention now being generally described, it will be more readily understood by reference to the following examples, which are included merely for purposes of illustration of certain aspects and embodiments of the present invention, and are not intended to limit the invention. EXAMPLE 1 [0127] Synthesis and Characterization of CD-bPEI With Altered CD Loading [0128] Branched PEI 25,000 (295.6 mg, Aldrich) and 6-monotosyl-β-cyclodextrin (2.287 g, Cyclodextrin Technologies Development, Inc.) were dissolved in 100 mL of various H 2 O/DMSO solvent mixture (Table 1). The resulting mixture was stirred at 70° C. for 72 h. The solution turned slightly yellow. The solution was then transferred to a Spectra/Por MWCO 10,000 membrane and dialyzed against water for 6 days. Water was then removed by lyophilization to afford a slightly colored solid. Cyclodextrin/PEI ratio was calculated based on the proton integration of 1 H NMR (Varian 300 Hz, D 2 O) δ 5.08 ppm (s br., C 1 H of CD), 3.3-4.1 ppm (m br. C 2 H-C 6 H of CD), 2.5-3.2 ppm (m br. CH 2 of PEI). [0129] The cyclodextrin loading on PEI was found to increase with decreasing amounts of H 2 O in the reaction mixture (Table 1). TABLE 1 Effect of H 2 O on cyclodextrin loading H 2 O/DMSO Amount of water (mL) (%) Ethyleneimine/CD 60/40 60 19.9 40/60 40 16.8 20/80 20 14.7  5/95 5 12.6  1/99 1 10.5  0.1/99.9 0.1 8.4  0/100 0 6.3 EXAMPLE 2 [0130] Synthesis of Linear PEI-CD [0131] Low loading: Linear PEI (50 mg, Polysciences, Inc., MW 25,000) was dissolved in dry DMSO (5 mL). Cyclodextrin monotosylate (189 mg, 75 eq., Cyclodextrin Technologies Development, Inc.) was added to the solution. The solution was stirred under Argon at 70-72° C. for 4 days. Then this solution was dialyzed in water (total dialysis volume around 50 mL) for six days (Spectra/Por 7 MWCO 25,000 membrane). 1PEI-CD (46 mg) was obtained after lyophilization. 1 H NMR (Bruker AMX 500 MHz, D 2 O) δ 5.09 (s br., C1 of CD), 3.58-4.00 (m br., C2-C6 of CD), 2.98 (m br., PEI). 8.8% of PEI repeats were conjugated with CD. [0132] High loading: Linear PEI (50 mg, Polysciences, Inc. MW 25,000) was dissolved in dry DMSO (10 mL). Cyclodextrin monotosylate (773 mg, 300 eq., Cyclodextrin Technologies Development, Inc.) was added to the solution. The solution was stirred under argon at 70-72° C. for 4 days. Then this solution was dialyzed in water (total dialysis volume around 50 mL) for six days (Spectra/Por 7 MWCO 25,000 membrane). Precipitation in dialysis bag was observed. The precipitate (unreacted CD-monotosylate) was removed using 0.2 μM syringe filter and the filtrant was dialyzed in a 25,000 MWCO membrane for another 24 hours. 1PEI-CD (75 mg) was obtained after lyophilization. 1 H NMR (Bruker AMX 500 MHz, D 2 O) δ 5.09 (s br., C1 of CD), 3.58-4.00 (m br., C2-C6 of CD), 2.98 (m br., PEI). 11.6% of PEI repeats were conjugated with CD. EXAMPLE 3 [0133] Synthesis and Characterization of CD-1PEI With Altered CD Loading [0134] Linear PEI 25,000 (500 mg, Polysciences, Inc.) and 6-monotosyl-β-cyclodextrin (3.868 g, Cyclodextrin Technologies Development, Inc.) were dissolved in 36 mL of DMSO. The resulting mixture was stirred at 70° C. for 6 days. The solution turned slightly yellow. The solution was then transferred to a Spectra/Por MWCO 10,000 membrane and dialyzed against water for 6 days. Water was then removed by lyophilization to afford a slightly colored solid. Cyclodextrin/PEI ratio was calculated based on the proton integration of 1 H NMR (Varian 300 MHz, D 2 O) δ 5.08 ppm (s br., C 1 H of CD), 3.3-4.1 ppm (m br. C 2 H-C 6 H of CD), 2.5-3.2 ppm (m br. CH 2 of PEI). In this example, the cyclodextrin/PEI ratio was 8.4. EXAMPLE 4 [0135] Formulations of CD-PEI With Plasmids: Salt Stabilization With AD-PEG Material [0136] Plasmid DNA (pGL3-CV, plasmid containing the luciferase gene under the control of an SV40 promoter) was prepared at 0.5 mg/mL in water. Branched CD-PEI was prepared at 2.0 mg/mL in water. AD-PEG 5000 was prepared at 10 mg/mL and 100 mg/mL in water. (See Examples 22-28 of U.S. patent application Ser. No. 10/021,312, filed Dec. 19, 2001, for details.) [0137] Polyplexes were prepared by mixing the desired amount of AD-PEG 5000 with 6 μL of branched CD-PEI. This polymer solution was then added to 6 μL of DNA solution. [0138] Polyplex solutions were transferred to a light-scattering cuvette. 1.6 mL of PBS (150 mM) was added and particle size measured immediately following salt addition for 10 minutes using a Zeta Pals dynamic light scattering detector (Brookhaven Instruments). Results are depicted in FIG. 1. [0139] Formulations of CD-PEI With Oligos: Salt Stabilization With AD-PEG [0140] Oligo DNA (FITC-Oligo) was prepared at 0.5 mg/mL in water. Branched CD-PEI was prepared at 2.0 mg/mL in water. AD-PEG 5000 was prepared at 10 mg/mL and 100 mg/mL in water. [0141] Polyplexes were prepared by mixing the desired amount of AD-PEG 5000 with 6 μL of branched CD-PEI. This polymer solution was then added to 6 μL of DNA solution. [0142] Polyplex solutions were transferred to a light-scattering cuvette. 1.6 mL of PBS (150 mM) was added and particle size measured immediately following salt addition for 10 minutes using a Zeta Pals dynamic light scattering detector (Brookhaven Instruments). Results are depicted in FIG. 2. EXAMPLE 5 [0143] Plasmid Transfection in vitro [0144] PC3 cells were plated at 200,000 cells/mL in 24-well plates. After 24 hours, the cells were transfected with 3 μg/well of pEGFP-Luc (plasmid containing the EGFP-Luc fusion gene under the control of a CMV promoter) complexed with branched CD-PEI at a 5:1 weight ratio. (For each well, transfection mixtures were prepared in 60 μL of water and then 1 mL of OptiMEM (a serum-free medium from Life Technologies) was added to the solutions. The final solutions were then transferred to the cells.) 4 hours after transfection, media was removed and replaced with 5 mL of complete media. Cells were analyzed by flow cytometry for EGFP expression 48 hours after transfection. EGFP expression was observed in 25% of analyzed cells. [0145] Oligo Delivery by Branched CD-PEI [0146] PC3 cells were plated at 300,000 cells/well in 6-well plates. After 24 hours, the cells were transfected with 3 μg/well of FITC-Oligo complexed with branched PEI (modified and unmodified) or branched CD-PEI at a 5:1 weight ratio. 15 minutes after transfection, cells were washed with PBS, trypsinized and analyzed by flow cytometry for uptake of the fluorescent oligos. EGFP expression was observed in 25% of analyzed cells. Results are depicted in FIG. 3. [0147] Transfection Efficiencies of Various CD-PEI Polymers [0148] PC3 cells were transfected with several CD-PEI polymers as listed below. Polymer Mass/monomer ethylenimine/CD b-PEI2000-CD-L 178 9.5 b-PEI2000-CD-H 216 7.4 b-PEI10000-CD-L  89 27 b-PEI10000-CD-H 111 19 b-PEI70000-CD-L  98 23 b-PEI70000-CD-H 119 16.8 l-PEI25000-CD-L 155 11.4 l-PEI25000-CD-H 192 8.6 [0149] The nomenclature is defined as follows: b-PEI2000-CD-L is cyclodextrin grafted to branched PEI of 2000 MW. A prefix of ‘1’ indicates a linear PEI substrate. The “L” and “H” stands for “lighter” and “heavier” grafted polymers (see the respective ethylenimine/CD ratios as listed on the right-most column). The CD-PEI polymers were prepared according to the protocol described in Example 1. [0150] PC3 cells were plated at 200,000 cells/well in 6-well plates. After 24 hours, the cells were transfected with 3 μg of plasmid of pEGFP-Luc plasmid assembled with CD-PEI polymers at 15 N/P in 1 mL of Optimem. Five hours after transfection, 4 mL of complete media was added to each well. Cells were trypsinized, collected, and analyzed by flow cytometry for EGFP expression 48 hours after transfection. The results are shown in FIG. 4. High transfection efficiency was observed with increasing molecular weight. Linear-PEI-based conjugates transfected with higher efficiency than branched-PEI-based conjugates. EXAMPLE 6 [0151] Toxicity of CD-PEI in vitro [0152] PC3 cells were plated at 60,000 cells/mL in 96 well plates (0.1 mL per well). After 24 hours, polymer solutions in media were added to the third column and diluted serially across the rows. The cells were incubated for 24 hours, after which they were washed with PBS and 50 μL of MTT (2 mg/mL in PBS) per well was added, followed by 150 μL of complete media per well. The wells were incubated for 4 hours. The solutions were then removed and 150 μL of DMSO was added. Adsorbance was then read at 540 nm. Results for branched CD-PEI are depicted in FIG. 5. [0153] Toxicities of Various CD-PEI Polymers. Comparisons to Mannosylated-PEI (Man-JET-PEI) [0154] The IC 50 's of cyclodextrin-grafted 1PEI and bPEI polymers in PC3 cells were determined by MTT assay. As a comparison, the IC 50 of mannosylated-PEI (man-JET-PEI) along with the parent PEI (JET-PEI), purchased from Polyplus Transfections (Illkirch, France), was determined for comparison. The IC 50 values were determined as follows: [0155] PC3 cells were plated at 60,000 cells/mL in 96-well plates for 24 hours (0.1 mL per well). Polymers were added to the third column in complete and diluted serially across the rows. After 24 hours, the cells were washed with PBS and 50 μL of MTT (2 mg/mL in PBS) was added per well followed by 150 μL of complete media. The media was removed after 4 hour incubation and 150 μL of DMSO was added. Adsorbance was read at 540 nm. [0156] The IC 50 values are shown in the chart below. Polymers are shown grouped in pairs (parent polymer and modified polymer) in the first column. The IC 50 value for each polymer is listed in the second column in μg/mL. The third column lists the decrease in toxicity by saccharide grafted, as calculated by the modified PEI IC 50 value divided by the parents PEI IC 50 value. The cyclodextrin-grafted PEIs have IC 50 values that are over forty times those of mannosylated PEI from Polyplus. In addition, modification with high grafting density results in a much higher increase in tolerability (90-fold vs. 20 fold) over parent polymers. Polymer IC 50 (μg/mL) Fold Increase b-PEI25000 7.5 b-PEI25000-CD 1000 133  l-PEI25000 11 l-PEI25000-CD 1000 90 JET-PEI 1.1 Man-JET-PEI 23 20 EXAMPLE 7 [0157] In vivo Delivery of DNA by Branched CD-PEI [0158] Balb-C mice were injected with PEGylated CD-PEI polyplexes containing 200 μg of pGL3-CV (15:5:1 AD-PEG: CD-PEI: pGL3-CV by weight) by portal vein injection. Mice were anesthesized, injected with luciferin, and imaged using a Xenogen camera 4.5 hours after injection. Luciferase expression was observed in the liver, as indicated by light emission as shown in FIG. 6. EXAMPLE 8 [0159] Transfection of Galactosylated CD-PEI to Hepatoma Cells in vitro [0160] CD-PEI based polyplexes (containing the α-luciferase plasmid) were modified by PEG-galactose and PEG by adding in AD-PEG 5000 -Galactose (adamantane-polyethylene glycol-galactose) or AD-PEG 5000 during polyplex formulation (for more information on adamantane conjugates and inclusion complexes thereof, see PCT publication WO 02/49676). The adamantane from AD-PEG 5000 -Galactose or AD-PEG 5000 forms inclusion complexes with the cyclodextrin and modifies the surface of the particles with PEG-galactose or PEG, respectively. These polyplexes were exposed to HepG2 cells, hepatoma cells expressing the asialoglycoprotein receptor. Polyplexes modified by galactose yielded a 10-fold increase in luciferase expression as shown in FIG. 7, indicating increased transfection by galactose-mediated uptake. EXAMPLE 9 [0161] Determination of Effect of CD-bPEI Cyclodextrin Loading on Transfection Efficiency [0162] PC3 cells were plated at 50,000 cells/well in 24-well plates 24 hours before transfection. Immediately prior to transfection, cells in each well were rinsed once with PBS before the addition of 200 μL of Optimem (Invitrogen) containing polyplexes (1 μg of DNA complexed with polycation synthesized as described in Example 1 at 10 N/P). After 4 hours, transfection media was aspirated and replaced with 1 mL of complete media. After another 24 hours, cells were washed with PBS and lysed by the addition of 100 μL of Cell Culture Lysis Buffer (Promega, Madison, Wis.). Cell lysates were analyzed for luciferase activity with Promega's luciferase assay reagent. Light units were integrated over 10 s with a luminometer (Monolight 3010C, Becton Dickinson). High transfection was observed with PEI:CD ratios greater than 10 (see FIG. 8). [0163] Determination of Effect of CD-bPEI Cyclodextrin Loading on Cell Toxicity [0164] PC3 cells were plated in 96-well plates at 5,000 cells/well for 24 hours. Polymers were added to the third column and diluted serially across the rows. After another 24 hours, cells were washed with PBS and 50 μL of MTT (2 mg/mL in PBS) was added per well followed by 150 μL of complete media. Media was removed after 4 hours incubation at 37° C. and 150 μL of DMSO was added to dissolve the formazan crystals. Absorbance was read 540 nm to determine cell survival. All experiments were conducted in triplicate and averaged. Average absorbance was plotted versus polymer concentration and IC 50 values were determined by interpolation within the linear absorbance region. The tolerability of the polymers increases as more CD is grafted onto bPEI (see FIG. 9). EXAMPLE 10 [0165] Determination of Effect of CD-1PEI Cyclodextrin Loading on Cell Toxicity [0166] The IC 50 of the CD-1PEI polymer to PC3 cells (with 8.4 PEI:CD, synthesis described in Example 3) was determined according to the procedure in Example 9 and compared with the IC 50 of the parent 1PEI polymer. The IC 50 of CD-1PEI (220 μg/mL) was 15 times greater than the IC 50 of 1PEI (15 μg/mL). [0167] Determination of Effect of Chloroquine on Transfection Efficiency With CD-1PEI [0168] PC3 cells were plated at 250,000 cells/well in 6-well plates. After 24 hours, the cells were transfected with 5 μg of pEGFP-luc plasmid assembled with polymer at N/P in 1 mL of Optimem (for some samples, Optimem containing 200 μM chloroquine was added). Four hours after transfection, media was removed and replaced with 5 mL of complete media. Cells were washed with PBS, trypsinized, and analyzed by flow cytometry for EGFP expression 48 hours after transfection. Grafting of cyclodextrin onto 1PEI at 8.4 PEI:CD does not affect transfection efficiency. Results are presented in FIG. 10. EXAMPLE 11 [0169] Formulation of CD-bPEI and CD-1PEI-based Particles [0170] An equal volume of polycation (dissolved in water or D5W) is added to DNA (0.1 mg/mL in water). The polymer nitrogen to DNA phosphate ratio (N/P) is varied by changing the concentration of the polycation solution. [0171] Electron Micrographs of CD-bPEI Particles [0172] Polyplexes were formulated using CD-bPEI (12.6 PEI:CD ratio) at 10 N/P as described above. 5 μL of polyplexes were applied to 400-mesh carbon-coated copper grids for 45 seconds, after which excess liquid was removed by blotting with filter. Samples were negatively stained with 2% uranyl acetate for 45 seconds before blotting. The 400-mesh carbon-coated copper grids were glow-discharged immediately prior to sample loading. Images, as depicted in FIG. 11, were recorded using a Philips 201 electron microscope operated at 80 kV. [0173] Particle Size and CD-bPEI and CD-1PEI Particles [0174] Particles were formulated using CD-bPEI (12.6 PEI:CD ratio) at 10 N/P as described above and then diluted by the addition of 1.2 mL of water. Particle size was measured using a ZetaPals dynamic light scattering detector (Brookhaven Instrument Corporation). Three measurements were taken for each sample and data reported as average size. Average Particle Diameter Standard Deviation Polymer (nm) (nm) bPEI 290 3 lPEI 115 2 CD-bPEI  96 1 CD-lPEI  93 1 [0175] Salt Stabilization of CD-bPEI and CD-1PEI Particles by the Addition of AD-PEG [0176] Particles were formulated as described above and then diluted by the addition of 1.2 mL PBS. Particle size was monitored using a ZetaPals dynamic light scattering detector every minute for 10 minutes. Samples were run in triplicate and data reported as average size at each time point. The addition of AD-PEG helps to stabilization CD-bPEI and CD-1PEI particles against salt-induced aggregation. Addition of AD-PEG to bPEI and 1PEI particles has no affect on salt-induced aggregation. Results are presented in FIG. 12. EXAMPLE 12 [0177] Oligonucleotide Delivery With CD-bPEI and CD-1PEI Particles [0178] PC3 cells were plated at 2,000,000 cells/well in 6-well plates. After 24 hours, the cells were transfected with 5 μg of fluorescently-labeled oligonucleotide complexed with polycation at 10 N/P. After 15 minutes, cells were washed with PBS, cell scrub buffer, and trypsinized and analyzed by flow cytometry for uptake of the polyplexes. CD-bPEI (12.6 PEI:CD) and CD-1PEI (8.4 PEI:CD) are efficient at delivering oligos to cultured cells. Results are depicted in FIG. 13. EXAMPLE 13 [0179] In vivo Tolerability of CD-1PEI and CD-bPEI Polymers [0180] Female, Balb/C mice were injected intravenously with CD-1PEI- and CD-bPEI-based polyplexes using a volume of 0.4 mL (D5W based solution) and injection speed of ˜0.2 ml/15 sec. Animals were sacrificed 24 hours after injection and blood collected for transaminase, creatinine, platelet and white blood cell analysis. Groups: 1. Control 2. CD-bPEI 10 N/P 0.1 mg DNA/mL 3. CD-bPEI 10 N/P 0.2 mg DNA/mL 4. CD-bPEI 10 N/P 0.3 mg DNA/mL 5. CD-lPEI 10 N/P 0.1 mg DNA/mL 6. CD-lPEI 10 N/P 0.2 mg DNA/mL 7. CD-lPEI 10 N/P 0.3 mg DNA/mL [0181] The maximum tolerable dose of CD-bPEI was determined to be 9 mg/kg (assuming 20 g mice, 0.1 mg DNA/mL dose). At the 0.2 mg DNA/mL dose, all animals survived but with depressed platelet counts. [0182] The maximum tolerable dose of CD-1PEI was determined to be at least 36 mg/kg (assuming 20 g mice, 0.3 mg DNA/mL dose). No platelet depression or elevated liver enzyme levels was observed. In addition, all animals survived at the highest dose injected. [0183] As a comparison, the LD 50 of 1PEI was determined to be ˜3-4 mg/kg (50% Balb/C mice died with an injection of 50 μg of DNA complexed with 1PEI at 10 N/P; Chollet et al. J Gene Medicine v4:84-91 (2002). [0184] In vivo Expression With CD-1PEI Polyplexes Injected Into Xenograph Tumors [0185] CD-1PEI particles were injected into tumors of Neuro2a tumor-bearing mice (120 μg DNA complexed with CD-1PEI at 10 N/P per mouse). After 48 hours, tumors were excised, homogenized and analyzed for luciferase expression. Average expression was determined to be: 2500 RLU/mg tissue. EXAMPLE 14 [0186] Synthesis of Galactose-bPEI [0187] Protocol: [0188] a. Synthesis of Tosyl-Galactose: [0189] p-Toluenesulfonylchloride (5.8 g, 30.5 mmol, Acros) in anhydrous pyridine (10 mL) was added dropwise to a solution of D-galactose (5 g, 27.8 mmol, Aldrich) in anhydrous pyridine (50 mL) at 0° C. The solution was stirred for 4 h at room temperature. The reaction mixture was then quenched with MeOH (2 mL), diluted with 75 mL of CHCl 3 , and washed twice with ice-cold water (50 mL). The organic phase was dried under reduced pressure. The residue was subjected to C8 reversed-phase column chromatography using a gradient elution of 0-50% acetonitrile in water. Fractions were analyzed on a Beckman Coulter System Gold HPLC system equipped with a UV 168 Detector, an Evaporative Light Scattering (ELS) Detector and a C18 reversed-phase column (Alltech) using an acetonitrile/H 2 O gradient as eluant at 0.7 mL/min flow rate. The appropriate fractions were combined and evaporated to dryness. This procedure gave the tosyl-galactose as confirmed by mass spectroscopy: Electrospray Ionization: 357.1 [M+Na] + , 690.7 [2M+Na] + . [0190] b. Synthesis of Galactose-bPEI with different galactose loading [0191] Low loading: Branched PEI 25,000 (64.9 mg, 0.0026 mmol, Aldrich, MW 25,000) and tosyl-galactose (13 mg, 0.039 mmol) was dissolved in 22 mL of H 2 O/DMSO (5/95). The solution was stirred at 70° C. for 3 days. The solution was then transferred to a Spectra/Por MWCO 10,000 membrane and dialyzed against water for 6 days. Water was then removed by lyophilization to afford a slightly colored solid. Galactose/PEI ratio was calculated based on the proton integration of 1 H-NMR (Varian 300 MHz, D 2 O). [0192] High loading: Branched PEI 25,000 (64.9 mg, 0.0026 mmol, Aldrich, MW 25,000) and tosyl-galactose (130 mg, 0.39 mmol) was dissolved in 22 mL of H 2 O/DMSO (5/95). The solution was stirred at 70° C. for 3 days. The solution was then transferred to a Spectra/Por MWCO 10,000 membrane and dialyzed against water for 6 days. Water was then removed by lyophilization to afford a slightly colored solid. Galactose/PEI ratio was calculated based on the proton integration of 1 H NMR (Varian 300 MHz, D 2 O). EXAMPLE 15 [0193] Synthesis of Galactose-1PEI [0194] Protocol: [0195] Low loading: Linear PEI 25,000 (100 mg, 0.004 mmol, Polyscience, MW 25,000) and tosyl-galactose (20 mg, 0.06 mmol) were dissolved in 7.2 mL of DMSO. The solution was stirred at 70° C. for 6 days. The solution was then transferred to a Spectra/Por MWCO 10,000 membrane and dialyzed against water for 6 days. Water was then removed by lyophilization to afford a slightly colored solid. Galactose/PEI ratio was calculated based on the proton integration of 1 H NMR (Varian 300 MHz, D 2 O). [0196] High loading: Linear PEI 25,000 (100 mg, 0.004 rnmol, Polyscience, MW 25,000) and tosyl-galactose (200 mg, 0.6 mmol) was dissolved in 7.2 mL of DMSO. The solution was stirred at 70° C. for 6 days. The solution was then transferred to a Spectra/Por MWCO 10,000 membrane and dialyzed against water for 6 days. Water was then removed by lyophilization to afford a slightly colored solid. Galactose/PEI ratio was calculated based on the proton integration of 1 H NMR (Varian 300 MHz, D 2 O). [0197] All of the above-cited references and publications are hereby incorporated by reference. [0198] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

1a

FIELD OF THE INVENTION [0001] This invention relates generally to the benefits of elevated expression of Integrin Linked Kinase (ILK), particularly to the cardioprotective effect evidenced as a result of upregulation of ILK post myocardial infarction, and most particularly to ILK mediated reduction of infarct size and beneficial increase in left ventricular mass post MI and to use of ILK as a means for cardiac stem cell proliferation and self-renewal. BACKGROUND OF THE INVENTION [0002] The major barrier to the use of stem cell therapy in regenerative medicine is the inability to regulate the dichotomous capacity for stem cell self-renewal versus the process of cell lineage commitment. The solution to this problem will require an improved understanding of the inductive signals and the cognate signal transduction pathways which determine cellular fate, and which specifically govern the competitive outcomes of self-renewal with maintenance of pluripotency, versus differentiation into a specialized tissue phenotype i . [0003] The evolutionarily conserved canonical Wnt pathway has been implicated in both human and mouse embryonic stem (ES) cell self-renewal competence ii . Inactivation of glycogen synthase kinase-3β (GSK-3β) leads to nuclear accumulation of β-catenin, which, in turn, leads to the activation of Wnt target genes implicated in the proliferation of endothelial precursor cells iii , and in self-renewal of HESCs iv . [0004] ILK is a protein Ser/Thr kinase that binds to the cytoplasmic domains of β1, β2 and β3-integrin subunits v . ILK is regulated in a phosphoinositide 3′-kinase (PI3K)-dependent manner following distinct signal inputs from integrins and growth factor receptor tyrosine kinases vi,vii . Conditional knockdown and RNA interference experiments indicate that ILK is required for phosphorylation of PKB/Akt Ser473 and GSK-3β Ser9 viii . Since inhibitory phosphorylation of GSK-3β is sufficient for maintenance of an undifferentiated phenotype in mouse and human ESCs, ILK is a candidate kinase activator of a critical stem cell signaling cascade. [0005] We have shown that cardiac-restricted ILK over-expression in a mouse model causes a compensatory (beneficial) form of cardiac hypertrophy. Molecular analysis revealed that ILK mediated hypertrophy is dependent upon a novel pathway involving activation of the small G-protein, Rac1. Gene expression profiling of ILK transgenic mice subjected to LAD ligation-induced myocardial infarction revealed up-regulation of transcripts linked to IL-6 and Janus-associated tyrosine kinase/signal transducer of activated transcription (JAK/STAT3) signaling. These studies establish ILK as an important new cardiovascular target. The activation of these signaling cascades in this myocardial injury model should be stimulative to stem cell recruitment based on their established role in cell renewal in mouse ESCs . [0006] We anticipate that fetal sources of tissue will be enriched for stem cells, given that stem cell activation recapitulates fetal programming. We have developed and characterized an in vitro model of human fetal cardiac myocytes (HFCM) ix , and characterized the genomic response to ischemic stress during human heart surgery in vivo x . We have shown that cardiac stem-like cells can be identified by c-kit staining in HFCM with a frequency approximately one order of magnitude higher than that described for adult heart xi . Further, we have shown that ILK gain-of-function increases the frequency of c-kit- and CD133-positive cardiac progenitor cells isolated from human myocardium, highlighting this as a rational approach to augment stem cell-based cellular therapy. [0007] Ventricular hypertrophy is an extremely common clinical condition that appears as a consequence of any variety of volume and or pressure overload stresses on the human heart. An increase in ventricular mass occurring in response to increased cardiac loading is generally viewed as a compensatory response, which serves to normalize ventricular wall tension and improve pump function. Conversely, a sustained or excessive hypertrophic response is typically considered maladaptive, based on the progression to dilated cardiac failure sometimes observed clinically, and the statistical association of ventricular hypertrophy with increased cardiac mortality. Whereas mouse models of cardiac hypertrophy have been generated by genetically-induced alterations in the activation state of various kinases in the heart, limited information is available regarding the role of specific signaling pathways activated during human ventricular hypertrophy. [0008] The identification of the kinase pathways implicated in human hypertrophy has important therapeutic implications, since it will allow testing of the hypothesis that enforced hypertrophy induction represents a beneficial remodeling response, and a useful strategy to preserve cardiac function and arrest the transition to a dilated phenotype. DESCRIPTION OF THE PRIOR ART [0009] U.S. Pat. Nos. 6,013,782 and 6,699,983 are directed toward methods for isolating ILK genes. The patents suggest that modulation of the gene activity in vivo might be useful for prophylactic and therapeutic purposes, but fails to teach or suggest any perceived benefit relative to over or under expression of ILK with respect to cardiac hypertrophy or post MI cardiac remodeling. SUMMARY OF THE INVENTION [0010] An increase in hemodynamic wall stress (also termed afterload) due to impedance to outflow of blood from either the right or left ventricle can result in concentric cardiac hypertrophy of the affected ventricle. Diseases affecting intrinsic cardiac function, such as coronary artery disease or various forms of cardiomyopathy, may indirectly increase afterload, and lead to a hypertrophic response involving the residual, non-diseased myocardium. [0011] Integrins have been implicated as a component of the molecular apparatus which serves to transduce biomechanical stress into a compensatory growth program within the cardiomyocyte, based on their role in linking the extracellular matrix (ECM) with intracellular signaling pathways affecting growth and survival. Melusin is a muscle protein that binds to the integrin β1 cytoplasmic domain and has been identified as a candidate mechanosensor molecule in the heart. Experimental aortic constriction in melusin-null mice results in an impaired hypertrophic response through a mechanism involving reduced phosphorylation of glycogen synthase kinase-3β (GSK3β), which inhibits a key nodal regulator of cardiac hypertrophic signaling. The role of melusin or other potential molecules participating in the endogenous hypertrophic response to disease-induced cardiac hypertrophy in humans, however, remains unknown. [0012] Integrin-linked kinase (ILK) is a protein Ser/Thr kinase that binds to the cytoplasmic domains of β1, β2 and β3-integrin subunits. ILK serves as a molecular scaffold at sites of integrin-mediated adhesion, anchoring cytoskeletal actin and nucleating a supramolecular complex comprised minimally of ILK, PINCH and β-parvin. In addition to its structural role, ILK is a signaling kinase coordinating cues from the ECM in a phosphoinositide 3′-kinase (PI3K)-dependent manner following distinct signal inputs from integrins and growth factor receptor tyrosine kinases. ILK lies upstream of kinases shown in experimental models to modulate hypertrophy, and is required for phosphorylation of protein kinase B (Akt/PKB) at Ser473 and GSK3β at Ser9. Rho-family guanine triphosphatases (GTPases, or G-proteins), including RhoA, Cdc42, and Rac1, modulate signal transduction pathways regulating actin cytoskeletal dynamics in response to matrix interaction with integrin and other cell surface receptors. Both RhoA and Rac1 have been shown to modulate cardiac hypertrophy. ECM adhesion stimulates the increased association of activated, GTP-bound Rac1 with the plasma membrane, suggesting a role for ILK in promoting membrane targeting of activated Rac1. ILK may also activate Rac1 through regulated interaction of the Rac1/Cdc42 specific guanine-nucleotide exchange factor (GEF), ARHGEF6/-PIX, with β-parvin, an ILK-binding adaptor, as occurs during cell spreading on fibronectin. ILK is thus positioned to functionally link integrins with the force-generating actin cytoskeleton, and is a candidate molecule in the transduction of mechanical signals initiated by altered loading conditions affecting the heart. [0013] The instant invention demonstrates that ILK protein expression is increased in the hypertrophic human ventricle, and further demonstrates that ILK expression levels correlate with increased GTP loading, or activation, of the small G-protein, Rac1. Transgenic mice with cardiac-specific activation of ILK signaling are shown to exhibit compensated LV hypertrophy. In agreement with the findings in the human hypertrophic heart, ventricular lysates derived from ILK over-expressing mice lines exhibit higher levels of activated Rac1 and Cdc42, in association with activation of p38 mitogen-activated protein (p38MAPK) and ERK1/2 kinase cascades. [0014] Additionally, increased ILK expression is shown to enhance post-infarct remodeling in mice through an increased hypertrophic response in myocardium remote from the lesion. The transgenic models indicate that ILK induces a program of pro-hypertrophic kinase activation, and suggest that ILK represents a critical node linking increased hemodynamic loading to a cardioprotective, hypertrophic signaling hierarchy. Moreover, the ILK transgenic mouse is shown to provide a new model of cardiac hypertrophy that is highly relevant to human cardiac disease. [0015] Protein kinases are increasingly understood to be important regulators of cardiac hypertrophy, however the critical question arises of whether kinases known to induce experimental hypertrophy are, in fact, up-regulated or activated as a feature of human cardiac hypertrophy. The instant invention unequivocally demonstrates increased expression and activity of a candidate mechano-sensor/transducer, namely ILK, in human cardiac hypertrophy. [0016] Moreover, it is shown that moderate up-regulation of ILK in the myocardium of transgenic mice causes a compensated form of cardiac hypertrophy, as evidenced by unimpaired survival, preserved systolic and diastolic function, and the absence of histopathological fibrosis. Among a number of hypertrophy-inducing protein kinases that were examined, only two, ILK and PKB, demonstrated elevated protein levels in association with hypertrophy. Of these, ILK was consistently elevated in both congenital and acquired hypertrophies. Importantly, in consequence of ILK expression, transgenic myocardium exhibited a strikingly similar profile of protein kinase activation, to that seen in human cardiac hypertrophy. The fact that ILK up-regulation is associated with mechanical load-induced hypertrophy (secondary to congenital and acquired forms of outflow tract obstruction), in which global cardiac function was preserved, provides compelling evidence that ILK activation is associated with a provokable, compensatory form of hypertrophy in the human heart. At the molecular level, the human and mouse data included herein suggest that ILK is a proximal mechanotransducer, acting to coordinate a program of “downstream” hypertrophic signal transduction in response to pressure overload in the myocardium. [0017] The lack of Akt/PKB and GSK3β phosphorylation in ILK over-expressing mice was unexpected, given that ILK is regulated in a PI3K-dependent manner, and has been shown to directly phosphorylate both target kinases in non-cardiomyocytes 10, 12, 13, 14, and contrasts with findings from genetic models of cardiac-specific PI3K and Akt/PKB activation, which feature increased phosphorylation of both Akt/PKB and GSK3β in proportion to the degree of hypertrophy. We note, however, that levels of PKB Ser473 and GSK-3β Ser9 phosphorylation are quite high in both murine and human control hearts, consistent with the requirement for a threshold basal level of activation of theses kinases, which may be permissive to the induction of ILK-mediated hypertrophic signaling. Our results are thus consistent with operation of a p110/ILK/Rac1 pathway, but suggest that the ILK-specific hypertrophy is not critically dependent upon increased phosphorylation of PKB/Akt or GSK3β. The relative de-activation of Akt/PKB during ILK transgenesis is consistent with the finding that activation of Akt/PKB and inhibitory phosphorylation of GSK3β occur in advanced failure, but not during compensated hypertrophy, in human hearts. Thus, the lack of highly activated Akt/PKB in murine and human hearts exhibiting elevated ILK expression may be a signature of compensated hypertrophy. [0018] Our results in transgenic mice with ILK over-expression, as well as in human hypertrophy, reveal the selective activation of ERK1/2 and p38 signaling pathways, despite evidence for the relative deactivation of PI3K-dependent signaling through Akt/PKB and GSK3β. Genetic stimulation of the ERK1/2 branch of the MAPK signaling pathway has been shown previously to be associated with a physiological hypertrophic response and augmented cardiac function. S6 kinases promote protein translation by phosphorylating the S6 protein of small ribosomal subunits, and are required for mammalian target of rapamycin (mTOR)-dependent muscle cell growth. Activation of p70 ribosomal protein S6 kinase (p70S6K) provides a potential pathway mediating ILK-triggered myocyte hypertrophy which is independent of the Akt/PKB pathway. Indeed, ILK is sufficient to regulate the integrin-associated activation of Rac1 and p70S6K, leading to actin filament rearrangement and increased cellular migration. Considered together, our results indicate conservation of downstream signaling specificity resulting from ILK activation in both murine and human hypertrophy. Full elucidation of the unique network of effectors induced during ILK gain-of-function is accomplished by application of high-throughput functional proteomic approaches to genetic models, as well as to stage-specific human diseases characterized by hypertrophic remodeling. [0019] The reciprocal pattern of activation of Rac1 and de-activation of Rho is well-precedented and reflects opposing effects of these monomeric GTPases on the cytoskeleton at the leading edge of migrating cells. Similarly, our results show reciprocal effects both in vitro and in vivo on the activation of Rac1/Cdc42 and Rho in response to ILK upregulation. These data are thus consistent with the observation that transgenic mice over-expressing RhoA develop a predominantly dilated cardiomyopathic phenotype which is antithetical to that observed with ILK activation. [0020] Our data indicates that hemodynamic loading secondary to infarct induction in ILK S343D Tg mice provoked a stress response, which resulted in a larger increase in LV mass and smaller infarct size relative to control. The mechanism(s) accounting for the post-infarction cardioprotective effects of ILK activation require further study, but our result is consistent with the report that thymosin β4 improves early cardiomyocyte survival and function following LAD ligation through a pathway shown to be dependent upon increased ILK protein expression. One putative explanation for the cardioprotective effect of ILK activation in this model is the reduction in wall stress secondary to the observed ILK-potentiated hypertrophic response. The importance of reactive hypertrophy of remote myocardium in limiting wall stress and adverse remodeling after MI has been shown both in patients, and in mice with loss-of-function mutations in pro-hypertrophic, calcineurin-dependent signaling pathways. Further, ILK/Rac1 activation in cardiac myofibroblasts may plausibly promote more efficient scar contraction through mechanisms related to effects on the actin cytoskeleton, which favor a more contractile, motile and invasive cellular phenotype. [0021] In summary, our results identify a novel role for ILK-regulated signaling in mediating a broadly adaptive form of cardiac hypertrophy. The effects of small molecule inhibitors of ILK demonstrated experimentally suggest that this pathway is therapeutically tractable, and together with our results, that modulation of the ILK pathway warrants evaluation as a novel approach to enhance the remodeling process relevant to a wide range of cardiac diseases. [0022] Accordingly, it is a primary objective of the instant invention to teach a process for instigating beneficial human hypertrophy as a result of overexpression of ILK. [0023] It is a further objective of the instant invention to teach a beneficial protective process for post MI remodeling as a result of ILK overexpression. [0024] It is yet another objective of the instant invention to teach a control for instigating ILK overexpression. The objective is to evaluate the capacity of ILK gain-of-function to promote stem cell self-renewal. This objective can be evaluated in a range of cell types derived from ESCs, fetal and adult tissue, available in our Lab and the NRC. Of interest will be the effect of modulation of ILK signaling amplification on stem cell frequency, and on cellular fate, focusing on self-renewal, multilineage differentiation, and the potential for oncogenesis. A major objective of the project is the development of novel methods for the identification, amplification and differentiation of cardiac stem cells. These studies will take into account the effect of instructive (extra-cellular) environmental cues on intra-cellular signal transduction events. The generic pro-survival effect of ILK up-regulation is predicted to enhance cellular transplantation survival, and this important effect can be evaluated in therapeutically relevant in vivo and in vitro models. ILK-based protocols will be investigated both as standalone strategies, and in conjunction with anti-oxidant strategies developed at the NRC. [0025] Other objects and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE FIGURES [0026] FIG. 1 : ILK expression in normal and hypertrophied human ventricles: a, Ventricular lysates from patients with congenital outflow tract obstruction (H1, H2), exhibiting severe hypertrophic valvular heart disease, and from (non-hypertrophic) normal human fetal (19 weeks old) ventricle (N1, N2), were immunoblotted for levels of ILK protein, with GAPDH as loading control. Ratios indicate ILK protein levels normalized to GAPDH. b, Ventricular lysates from hypertrophic (HOCM) and normal (non-hypertrophied) human hearts were analyzed by western blotting for levels of ILK and ParvB. GAPDH was the loading control. [0027] FIG. 2 Rac, Rho and Cdc42 expression in human heart tissue: a, Normal and hypertrophic (HOCM) human ventricular lysates ( FIG. 1 ) were assayed for activation of Rho family GTPases, as indicated. b, Ventricular lysates from the congenital samples (H1, H2) and normal human fetal hearts (19 weeks, FIG. 1 ) were assayed for Rho family activation. Ratios represent densitometric values of activated/total GTPase signals for Rho, Rac1 and Cdc42. [0028] FIG. 3 : Phosphorylation of GSK3β, PKB, and MAP kinase in human heart tissue: a, Ventricular lysates labeled N1, N2, H1 and H2 were as in FIGS. 1 and 2 , above. b and c, Ventricular lysates from normal and hypertrophic human adult hearts, were as in FIGS. 1 and 2 . Lysates were resolved by SDS-PAGE and analyzed by western blotting for levels of the indicated total and phosphorylated proteins. [0029] FIG. 4 : Characterization of ILK S343D transgenic mice: a, Genomic DNA from ILK S343D Tg and NTg littermates was analyzed by Southern blotting using a human ILK cDNA probe. b, ILK-specific RT-PCR of total RNA isolated from heart tissue with (upper panel) or without (control, middle panel) reverse transcriptase, and on skeletal muscle (bottom panel) with reverse transcriptase. This yields the expected product 1.46 kb in length, expressed in the hearts of Tg mice, but not in the hearts of NTg littermates or skeletal muscle of the Tg mice. The lane marked ‘P’ is the PCR product obtained using α-MHC/ILK plasmid as template. This product is larger than 1.46 kb because the PCR primers encompass exons 1 and 2 of the α-MHC promoter. c, Western immunoblot analysis of ILK protein levels in ILK Tg and control (NTg) hearts. Signal densities normalized to that of GAPDH were 3-fold higher in ILK Tg hearts. d, ILK immune complex kinase assays of heart lysates from ILK S34D Tg and NTg littermates. Purified myosin light chain II, 20 kDa regulatory subunit was added as exogenous substrate. [0030] FIG. 5 : Increased cardiomyocyte size in ILK S343D Tg mice: a, Gross morphology of hearts from ILK S343D Tg mice and NTg littermates. Enlarged hearts of ILK S343D mice exhibited concentric hypertrophy evident by an approximate 25% increase in heart weight to body weight ratios relative to that in NTg controls (controls for all comparisons are age- and sex-matched littermates, see Table 2B). Histological studies using Masson's trichrome and picrosirius red staining (not shown) indicated no conspicuous increase in collagen in the ILK S343D Tg hearts. b, Mean values of cardiomyocyte areas based on approximately 500 cells per mouse with centrally positional nuclei. This analysis indicated a 20-25% increase in cardiomyocyte area, thereby accounting for the observed increase in LV mass. c, Representative echocardiograms showing details of dimensional measurements. At 15 months, ILK S343D Tg mice exhibited significant increases in LV mass as well as LV cavitary dimensions at end-systole and end-diastole (p<0.05), and preserved LV function based on echocardiography (% fractional shortening, Table 1, Supplemental) and invasive hemodynamic measurements (Tables 2 and 3, Supplemental). [0031] FIG. 6 : Selective activation of hypertrophic signaling in ILK WT , but not ILK R211A transgenic hearts: Ventricular lysates from a) ILK WT and b) ILK R211A Tg mice were assayed for activation of Rac1, Cdc42 and RhoA, using specific immunoaffinity assays as described in Materials and Methods. In each panel, parallel assays of ventricular lysates from littermate NTg controls are shown. Ventricular lysates from c) ILK WT and d) ILK R211A Tg mice were resolved by SDS-PAGE and analyzed by western blotting for levels of the indicated total and phosphorylated proteins. GAPDH was analyzed in parallel as loading control. Controls were NTg littermates. e. Ventricular lysates form ILK WT and ILK R211A mice were analyzed by western blotting for total ILK, HA tag, and the ILK-associated adaptor, ParvB, as indicated. [0032] FIG. 7 : Selective activation of Rho family GTPases by ILK WT , but not ILK R211A in primary human cardiomyocytes: a. Primary human fetal cardiomyocytes were infected with adenoviruses, with or without (EV) ILK WT or ILKR 211A cDNA. At 48 hr post-infection, cells sere harvested and lysates assayed for activation of Rho family GTPases. As indicated, cultures were infected in the presence of the small molecule ILK inhibitor, KP-392. [0033] FIG. 8 : Cardiac expression of ILK S343D improves post-infarct remodeling: LV infarction was created in 6 month ILK S343D (ILK Tg) and littermate control (NTg) mice by LAD ligation. The ILK TG genotype exhibited a significantly greater LV mass (p=0.01) and a reduction in scar area indexed to LV mass (p=0.047), as determined by planimetry at 7 days post-infarction. Upper panels, pre LAD ligation; lower panels, post LAD ligation. [0034] FIG. 9 : Activation of hypertrophic signaling in ILK S343D Tg mice: Hearts from two Tg ILK S343D and two NTg littermate controls were extracted and proteins resolved on 10% SDS-PAGE. Western blotting using antibodies against total and phosphorylated forms of the indicated protein kinases was performed to assess the relative activation levels of these pathways. For PKB and GSK3β determinations the ratio of densitometric signals of phosphorylated/total protein were determined for each sample, and are displayed under the panels. GAPDH was used as a loading control. [0035] FIG. 10 : Selective activation of Rac1 and Cdc42 in ILKS343D Tg mice: Affinity-based precipitation assays were conducted (see Methods) to determine the ratio of GTP-bound (activated) to total: a) Rac1, b) Cdc42 and c) RhoA GTPases in cardiac lysates of ILK S343D Tg and non-Tg littermate mice. Histograms summarize data from 4 hearts of each genotype. [0036] FIG. 11 : Adenovirus encoding either the human wild-type human gene linked to GFP (AD.ILK) or empty virus (Ad.C) was used to infect human fetal cardiomyocytes cultured in IMDM supplemented with 10% fetal bovine serum. a Effective gene transfer was confirmed by more than 80% GFP positivity. b ILK infection increased ILK protein expression ˜3-fold; the western blots shown are representative of 5 independent experiments. c Cardiac cell cultures labeled with c-Kit (green) and cardiac myosin MF20 (red). Nuclei were stained with DAPI (blue). Scale bar=10 mm. d Cultures infected with ILK yielded a significant ˜(*p=0.001)˜5-fold increase in both the absolute number and the frequency of c-Kit POS cells, which reached ˜one cell in 250. Analysis is based on 5 independent experiments. Error bars indicate standard error of the mean. [0037] FIG. 12 : Primary cardiospheres (CS) were generated from human fetal cardiomyocytes grown in serum-free media supplemented with bFGF and EGF (Methods) and imaged using natural light phase microscopy. Dissociated primary CS comprised of homogeneous phase-bright cells placed in wells containing same media gave rise to secondary CS in approximately 60% of wells. [0038] FIG. 13 : Cardiospheres were comprised of cells expressing the c-Kit POS surface receptor. Occasional cells at the periphery of the spheres stain for the cardiac marker α-actinin (arrow), suggesting a radial gradient in the differentiation of constituent cells. [0039] FIG. 14 : a Cardiospheres were observed in human fetal cardiac cell cultures. Cardiac cells were infected with adenoviral ILK (Ad.ILK) or empty viral vector (Ad.C) (at 10 pfu/ml), or left untreated (Control). ILK infection resulted in significant (*p<0.01) increases in the absolute number and frequency of CS at all plating densities tested. b The number of primary sphere initiating cells ratio was significantly higher in ILK-infected cells (*p=0.002). Whereas 0.41±0.073% of ILK-infected cells generated spheres, only 0.037±0.014% of control cells and 0.035±0.006% of virus-only cells generated spheres. Analysis is based on 6 independent experiments. Error bars represent standard error of the mean. [0040] FIG. 15 : a Secondary cardiospheres (CS), derived from cells isolated from a dissociated primary CS, shown in upper left panel, contains ILK-infected GFP POS cells. CS were placed in differentiating medium (IMDM+10% FBS) containing the 5-methyltransferase inhibitor, 5-Aza-deoxycytodine (10 μM) for 14 days. b Arrows indicate CS containing cells marked by DAPI staining, which are also positive for the cardiomyocyte-specific marker, α-cardiac actinin. Lower panel (left) shows a higher power view of cells migrating outward from CS, 45-50% of which are cardiomyocytes. Lower panel (right) shows that ˜10% of CS-derived cells stain positively (green) for von Willebrands Factor (vWF), indicative of endothelial cell lineage. 35-40% of cells stained positively for α-smooth muscle actin (not shown). c The differentiation profiles were similar among ILK-infected (Ad.ILK), empty virus (AD.C), and control CS. This result indicates the feasibility of manipulating the phenotypic outcome of cardiac progenitor cells, even among ILK-transformed cells. DETAILED DESCRIPTION OF THE INVENTION Methods Generation of α-MHC-ILK Transgenic Mice [0041] All protocols were in accordance with institutional guidelines for animal care. All procedures and analyses were performed in a fashion blinded for genotype, and statistical comparisons were made between ILK transgenic mice and sex-matched littermate non-transgenic mice. A 1.8 kb EcoRI fragment comprising the full length ILK cDNA was excised from a pBSK plasmid, and filled-in for blunt end ligation into a SalI site downstream of the murine a-myosin heavy chain promoter. Site directed mutagenesis (QuickChange Kit, Stratagene) was performed to generate constitutively active ILK (S343D), and kinase-inactive ILK (R211A) mutants using the wild type a-MHC/ILK plasmid as template. DNA sequencing confirmed the point mutations. Pronuclear microinjection of the linearized a-MHC/ILK plasmids into 0.5 day fertilized embryos was performed at the Core Transgenic Facility of the Hospital for Sick Children Research Institute. Transgene expression in C57BL/6 founder and F1 progeny mice was confirmed by Southern analysis and RT-PCR as described, using primers specific for the exogenous ILK transgene. The forward primer: 5′GTCCACATTCTTCAGGATTCT3′, specific for exon 2 of −MHC promoter, and the ILK-specific reverse primer: ‘ACACAAGGGGAAATACC GT3’, were used for the reaction. These primers amplify a 1460 bp across the α-MHC-ILK fusion junction. F1 progeny derived from one of several independent founder lines were selected for detailed phenotypic analysis based on readily discernible increases in ILK expression ( FIG. 4 ). All transgenic mouse procedures were performed in conformance with the policies for humane animal care governing the Core Transgenic Facility of the Hospital for Sick Children Research Institute and the Animal Research Act of Ontario. Cardiac Hemodynamic Measurements [0042] All surgical procedures were performed in accordance with institutional guidelines. Mice were anesthetized in the supine position using ketamine-HCl (100 mg/kg ip) and xylazine-HCl (10 mg/kg ip), and maintained at 37° C. The right common carotid artery was isolated after midline neck incision and cannulated using a Millar Micro-tip pressure transducer (1.4 F sensor, 2 F catheter; Millar Instruments, Houston, Tex.). Heart rate (beats per minute), systolic and diastolic LV pressures (mm Hg) were recorded, and peak positive and negative first derivatives (maximum/minimum+/−dp/dt; mmHg/second) were obtained from LV pressure curves using Origin 6.0 (Microcal Software, Inc., Northampton, Mass.). Two-Dimensional Echocardiography [0043] Serial two-dimensional echocardiography (2-D echo) was performed in male ILK transgenic and non-transgenic littermate mice at 10-12 weeks, at 5, and 15 months of age. An ultrasound biomicroscope (UBM) (VS40, VisualSonics Inc., Toronto) with transducer frequency of 30 MHz was used to make M-mode recordings of the LV. Mice were lightly anesthetized with isoflurane in oxygen (1.5%) by face mask, and warmed using a heated pad and heat lamp. Heart rate and rectal temperature were monitored (THM100, Indus Instruments, Houston, Tex.) and heating adjusted to maintain rectal temperature between 36 and 38° C. Once anesthetized, the mouse precordial region was shaved and further cleaned with a chemical hair-remover to minimize ultrasound attenuation. With the guidance of the two-dimensional imaging of the UBM, M-mode recording of left ventricular wall motion was obtained from the longitudinal and short axis views of the LV at the level with the largest ventricular chamber dimension. Anterior and posterior LV free wall thickness, and ventricular chamber dimensions were measured at end-systole and end-diastole; the contractility indices, velocity of circumferential fiber shortening (Vcf) and % fractional shortening, and LV ventricular mass, were calculated as described. Determination of significant, genotype-specific differences in 2-D echo and cardiac catheterization data relied on a paired t-test or ANOVA in the case of serial measurements. ILK Immune Complex Kinase Assay [0044] Cells were lysed in NP40 buffer, supplemented with 1 mM sodium orthovanadate and 5 mM sodium fluoride as phosphatase inhibitors. Equal amounts of protein from these cell lysates were immunoprecipitated with −ILK polyclonal antibody as previously described 10, and immune complexes were incubated at 30 C for 30 min with myosin light chain II regulatory subunit (MLC20) (2.5 g/reaction) and [32P] ATP (5 Ci/reaction). The reactions were stopped by addition of 4× concentrated SDS-PAGE sample buffer. Phosphorylated proteins were separated on 15% SDS-PAGE gels. [32P]MLC20 was visualized by autoradiography with X-Omat film. Rho Family GTPase Activation Assays [0045] Measurement of activated RhoA was performed using a pull-down assay based on specific binding of Rho-GTP to Rho-binding domain (RBD) of the Rho effector molecule, rhoketin43. Cdc42 and Rac1 activation were measured using a pull-down assay, based on the ability of the p21-binding domain of p21 associated kinase (PAK) to affinity precipitate Rac1-GTP and Cdc42-GTP, as described. RBD expressed as a GST fusion protein bound to the active Rho-GTP form of Rho was isolated using glutathione affinity beads according the manufacturer's protocol (Cytoskeleton). The amount of activated Rho was determined by Western blot using a Rho-specific antibody (Santa Cruz) and normalized as a ratio to the total amount of anti-Rho antibody detected in a 1/20 fraction of clarified lysate. Activated Rac and Cdc42 were measured by the same protocol using the p21-binding domain of PAK to affinity precipitate Rac-GTP, which was quantitated using an anti-Rac antibody (Cytoskeleton, Inc.) or anti-Cdc42 (Santa Cruz). Blots were developed with SuperSignal West Femto substrate (Pierce) for the GST-PAK/RBD pull-down assays. Histopathology [0046] The hearts were weighed, paraffin-embedded, sectioned at 1 mm intervals, and stained with hematoxylin and eosin and Sirius Red using standard methods. Micrographs were taken using both low magnification (×2.5) and higher magnification (×40) using fluorescent microscopy and genotype-specific cardiomyocyte areas determined based on digital measurements of >500 cells per animal and 5 animals per genotype using Image J software (http://rsb.info.nih.gov/ij/). Scanning electron microscopy was performed on ventricular samples placed in 1% Universal fixative for several hours at 4° C. and post-fixed in OsO4, using the JSM 6700FE SEM microscope. Infarct Induction [0047] LV infarction was created in 6 month ILK TgS343D and littermate control mice by LAD ligation as described. Planimetric scar dimensions measured in six levels of hematoxylin and eosin-stained cross-sections of the LV at 7 days post-infarction. Antibodies, and Immunoblot Analyses for Total and Phospho-Protein Levels [0048] Total and phospho-specific protein expression was measured in lysates derived from human fetal cardiomyocytes in culture and from transgenic and control mouse ventricular tissue as described previously. Immunoblotting was performed with the following commercially available antibodies. Polyclonal rabbit antibodies against ILK, p38MAPK, p70S6K, p44/42 MAPK (ERK1/2), and ATF-2 were purchased from Cell Signaling Technologies. Phospho-specific antibodies of pp 38MAPK (Thr180/Tyr182), pp70S6K (Thr421/Ser424), pPKB (Ser473), pGSK3B (Ser9), pp 44/42 MAPK (Thr202/Tyr204), and pATF-2 (Thr69/71) were purchased from Cell Signaling. Mouse monoclonal antibodies recognizing PKB, GSK3β, and RhoA were purchased from Transduction Labs. Rabbit polyclonal hemaglutinin (HA), and monoclonal Cdc42 antibodies were obtained from Santa Cruz Biotechnology. Rabbit polyclonal Rac1 antibody was purchased from Cytoskeleton, Inc. We generated a β-parvin (ParvB) rabbit polyclonal serum and affinity-purified these antibodies over an immobilized GST-ParvB column. Mouse monoclonal GAPDH was purchased from Ambion, Inc. Proteins were visualized with an enhanced chemiluminescence (ECL) detection reagent (Amersham Pharmacia Biotech) and quantified by densitometry. Adenovirus-Mediated Expression of ILK Variants in Primary Cardiomyocytes [0049] Human fetal cardiomyocytes (HFCM) (gestational age 15-20 weeks) were obtained under an Institutional Review Board-approved protocol and cultured to approximately 50% confluency (day 3-4 post-plating) in preparation for adenovirally-mediated infection of ILK constructs, as previously described. Replication-deficient serotype 5 adenovirus encoding either the human wild-type ILK gene (Ad-ILK WT ), kinase inactive (Ad-ILK R211A ) or empty virus constructs previously shown to modulate ILK expression and activity in L6 myoblasts, were used for infection of HFCM. HFCM were infected at 37° C. at multiplicity of infection of 2. KP392 is a small molecule inhibitor of ILK which was used to probe the effects of ILK on the profile of Rho family GTPase activation. Human Ventricular Samples [0050] Human right ventricular samples were derived from two patients with congenital outflow tract obstruction undergoing surgical repair, and left ventricular myocardial samples from five patients with hypertrophic obstructive cardiomyopathy (HOCM) presenting with discrete subaortic muscular obstruction. Control human ventricular tissue was acquired from structurally normal hearts (n=5) which were not used for cardiac transplantation. All human tissue samples were snap-frozen in liquid nitrogen at the time of procurement. All human tissue was acquired following protocol review and approval by the appropriate Research Ethics Board, and the protocols were conducted in accordance with the Tri Council Policy Statement for Research Involving Humans. [0051] ILK protein levels are elevated in cases of human cardiac hypertrophy. In order to test for the participation of ILK in hypertrophic heart disease in vivo, we examined ILK expression in human ventricular tissue samples from patients with and without clinically evident hypertrophy. Ventricular samples were acquired from two patients in the first year of life with ventricular hypertrophy secondary to congenital outflow tract obstruction; control ventricular tissue was derived from structurally normal 19 week human fetal hearts (n=2), and examined in parallel for levels of ILK expression. Ventricular tissue from these hearts exhibited a 5-6 fold increases in ILK protein levels over control levels ( FIG. 1 a ). [0052] We then investigated whether ILK protein expression was elevated in hypertrophy caused by left ventricular outflow tract obstruction (LVOT), since clinical hypertrophic heart disease more commonly affects the LV. Surgical specimens were acquired from the LVOT in adult patients (n=4) with hypertrophic obstructive cardiomyopathy (HOCM) exhibiting resting LVOT gradients>50 mmHg. Control ventricular tissue was obtained from structurally normal hearts (n=5) at the time of multi-organ transplantation procurement. Myocardial samples from HOCM patients exhibited a ˜2 fold increase in ILK protein levels relative to control hearts ( FIG. 1 b ). Thus, the cases of clinical hypertrophy all demonstrate elevation of ILK protein, suggesting this is a critical molecular response to increased cardiac loading and the development of hypertrophy. [0053] ILK has been shown to activate Rho family GTPases, which have also been causally implicated in experimental hypertrophy. We therefore assayed the ventricular tissues directly for activation of RhoA, Cdc42 and Rac1 GTPases, using specific affinity binding assays that distinguish the GDP-bound (inactive) and GTP-bound (active) states of each. Strikingly, there was a ˜2-fold and 10-fold increase in Rac1 GTP loading in the hypertrophic ventricular samples from patients with acquired and congenital and outflow tract obstruction, respectively ( FIGS. 2 ab ). Cdc42 activation of ˜2-fold was also evident in both acquired and congenital hypertrophic lesions. Conversely, the levels of GTP-bound RhoA were unchanged between the control and hypertrophied ventricles. These results indicate selective activation of Rac1, and to a lesser extent, Cdc42, coincident with increased ILK protein levels, in human ventricular hypertrophy induced in both left and right ventricles by obstructive hemodynamic loading. [0054] As the pro-hypertrophic kinases, Akt/PKB, GSK3β, and ERK1/2, are known targets of ILK, we ascertained whether these proteins were also elevated in the cases of human hypertrophy. Western blotting for total protein indicated equivalent levels of GSK3β and ERK1/2 in the hypertrophied hearts, and an increase in PKB ( FIG. 3 ). We tested the hypertrophic hearts for concordant increases in the phosphorylation state of known kinase targets of ILK that have also been implicated in the promotion of cardiac hypertrophy. Surprisingly, the phosphorylation state of the classical hypertrophic signaling targets, Akt/PKB and GSK3β, was not increased above control levels in any of the samples from the human hypertrophic ventricles ( FIGS. 3 ab ), despite the increased ILK protein levels in these samples. This result suggests that a putative ILK-Rac1 hypertrophic pathway is separable from ILK signaling through PKB/Akt and GSK3β. ERK1/2, p38MAPK8, and p70S6K, are kinases downstream of ILK which have also been implicated in promotion of experimental cardiac hypertrophy in vivo. In contrast to Akt/PKB and GSK3β, ERK1/2 and p70S6K were strongly phosphorylated in ventricular lysates in the setting of LVOT obstruction ( FIG. 3 c ), indicative of an activation profile of ILK kinase targets induced during human hypertrophy which appears to exhibit a degree of selectivity. [0055] Cardiac-specific expression of activated ILK in transgenic mice induces hypertrophy. The selective elevation of ILK levels in clinical cases of cardiac hypertrophy prompted us to ask whether increased ILK expression is causative of cardiac hypertrophy. To directly test hypertrophic responses to ILK in vivo, we derived independent lines of transgenic mice harboring different ILK transgenes, expressed under control of the cardiac specific −MHC promoter. As discussed above, ILK is a multifunctional protein24, thus our strategy was to generate lines expressing ILK variants that would allow us to differentiate kinase-dependent and -independent ILK functions in the heart. Toward this end, lines expressing: 1) constitutively activated, ILK S5343D , 2) wildtype, ILK TgWT, and 3) kinase-inactive ILK, ILK R211A , were derived. Southern blot analyses of genomic DNA identified mice carrying the ILK S343D transgene ( FIG. 4 a ), and RT-PCR analysis indicated cardiac-specific expression of ILK S343D ( FIG. 4 b ). Densitometric analysis of western blots indicated that transgenic ILK S343D protein levels were approximately 3-fold higher in transgenic animals, relative to non-transgenic littermates ( FIGS. 4 c ), and comparable to the increased levels seen in the clinical hypertrophic samples. Importantly, immune complex kinase assays confirmed that ILK activity in transgenic heart tissue measured in the ILK S343D genotype was elevated relative to non-transgenic controls, in parallel with ILK protein levels ( FIG. 4 d ). Similar analyses confirmed generation of ILK WT and ILK R211A transgenic lines (not shown). [0056] Hearts from ILK S343D Tg mice exhibited concentric hypertrophy, evidenced by gross enlargement and increased heart weight:body weight ratio ( FIG. 5 a ; Supplementary Table 1), and echocardiographic measurements showing significant LV wall thickening, compared to NTg mice (Supplementary Table 2). We observed an approximately 29% increase (p<0.001) in cardiomyocyte area in ILK S343D Tg animals, as assessed in laminin-stained sections of LV ( FIG. 5 b ), which is sufficient to account for the observed cardiac enlargement in ILK S343D Tg mice, suggesting ILK activity regulates cardiomyocyte size, rather than proliferation. There was no conspicuous increase in collagen deposition in the ILK S343D Tg hearts, as assessed histologically using Masson's trichrome ( FIG. 5 b ) or picrosirius red staining. The ILK S343D Tg mice appeared healthy, with no evidence of peripheral edema or cardiac failure, as there were no ILK-induced differences in absolute or body weight-indexed lung and liver weights (Supplementary Table 1). These data indicate that expression of activated ILK in the heart induces hypertrophy without the development of cardiac failure. [0000] TABLE 1 Supplemental. Heart, lung, liver weights of ILK S343D transgenic mice Non- % p- Transgenic Transgenic Increase value 7 weeks No. of mice n = 7 n = 7 Body weight (g)  21 ± 4.5  22 ± 2.7 −4.5 NS Heart weight (mg) 144 ± 7.8  126 ± 7.9  14 <0.05 Lung weight (mg) 173 ± 22  183 ± 16  −5.5 NS Liver weight (mg) 1267 ± 319  1275 ± 160  −0.6 NS Heart/Body weight 6.9 ± 1.3 5.7 ± 0.7 21 <0.05 (mg/g) Lung/Body weight 8.2 ± 1.6 8.3 ± 0.9 0.0 NS (mg/g) Liver/Body weight  60 ± 5.6 58 ± 23 3.0 NS (mg/g) 15 months No. of mice n = 7 n = 6 Body weight (g)  45 ± 3.5  41 ± 4.3 9.8 NS Heart weight (mg) 233 ± 22  167 ± 19  40  <0.001 Lung weight (mg) 203 ± 25  197 ± 34  3.0 NS Liver weight (mg) 1602 ± 410  1510 ± 324  6.0 NS Heart/Body weight 5.2 ± 0.5 4.1 ± 0.5 27 <0.05 (mg/g) Lung/Body weight 4.5 ± 0.8  4.8 ± 0.97 −4.0 NS (mg/g) Liver/Body weight  36 ± 6.8  37 ± 6.4 −2.7 NS (mg/g) [0057] To further characterize ILK S343D -induced hypertrophy, M-mode echocardiography was performed at 3, 5 and 15 months of age in male ILK Tg S343D and NTg mice. At all time points, ILK S343D Tg mice exhibited significant increases in LV mass as well as LV free wall dimensions at end-systole and end-diastole ( FIG. 5 c , Supplementary Table 2). Cardiac function, however, was preserved as assessed by measures of LV wall shortening fraction and the velocity of LV circumferential fiber shortening (Vcf). Invasive hemodynamic measurements performed at 3 months revealed no significant differences in measures of contractility (dp/dtmax), lusitrophy (dp/dtmin), afterload or heart rate in ILK TgS343D mice relative to NTg controls (Supplementary Table 3), indicating that ILK-induced hypertrophy does not alter cardiac function. Thus, based on the observed lack of cardiac failure and normal hemodynamic function, the cardiac phenotype associated with ILK S343D expression is indicative of a compensated form of hypertrophy. [0000] TABLE 2 Supplemental. Echocardiography of ILK S343D transgenic mice Transgenic Non-transgenic 3 months 15 months 3 months 15 months No. of mice n = 8 n = 7 n = 7 n = 6 LVEDAW (mm) 0.93 ± 0.12* 1.21 ± 0.21* 0.75 ± 0.11 0.99 ± 0.12 LVEDD (mm) 3.97 ± 0.34  4.77 ± 0.24* 4.04 ± 0.68 4.49 ± 0.16 LVEDPW (mm) 0.85 ± 0.21* 0.96 ± 0.13*  0.64 ± 0.027 0.83 ± 0.12 LVESAW (mm) 1.36 ± 0.20* 1.66 ± 0.22* 1.86 ± 0.12 1.39 ± 0.15 LVESD (mm) 2.65 ± 0.41  3.53 ± 0.24* 2.68 ± 0.54 3.25 ± 0.27 LVESPW (mm) 1.18 ± 0.25  1.30 ± 0.19  0.98 ± 0.23 1.09 ± 0.30 Vcf (mm/s) 18.76 ± 1.97  21.15 ± 4.58  18.58 ± 3.95  20.29 ± 3.96  % FS 33.44 ± 6.07  28.32 ± 4.17  33.98 ± 9.61  27.8 ± 4.71 Stroke Volume (mm 3 ) 2.37 ± 0.93  2.57 ± 1.19  2.86 ± 1.98 2.09 ± 1.0  LV Mass (mg 3 ) 136 ± 13** 239 ± 51** 104 ± 13  170 ± 22  *p < 0.05, **p < 0.001, vs NTg mice. LVEDAW, LV end-diastolic anterior wall thickness; LVEDD, LV end-diastolic dimension; LVEDPW, LV end-diastolic posterior wall thickness; LVESAW, LV end-systolic anterior wall thickness; LVESD, LV end-systolic dimension; LVESPW, LV end-systolic posterior wall thickness; Vcf, Velocity of circumferential fiber shortening; % FS, % fractional shortening. [0000] TABLE 3 Supplemental. Hemodynamic function in ILK S343D transgenic mice ILK S343D Non-Transgenic p-value No. of mice n = 9 n = 10 Heart rate (bpm) 256 ± 14  246 ± 20  NS ABPs (mmHg)  93 ± 2.9  90 ± 1.6 NS ABPd (mmHg)  62 ± 4.3  58 ± 2.4 NS LVSP (mmHg)  92 ± 1.7  95 ± 2.6 NS LVDP (mmHg)  16 ± 2.2  16 ± 1.8 NS RVSP (mmHg)  27 ± 0.9  26 ± 0.8 NS RVDP (mmHg) 2.8 ± 0.7 2.9 ± 0.6 NS dp/dt+ (mmHg/sec) 4717 ± 190  4100 ± 322  NS dp/dt− (mmHg/sec) 3342 ± 347  3649 ± 201  NS dp/dt+ (mmHg/sec), maximal rate of isovolumic LV pressure change; dp/dt− (mmHg/sec), minimum rate of isovolumic LV pressure change; ABPs, aorotic systolic blood pressure; ABPd, aorotic diastolic blood pressure; LVSP, left ventricular systolic pressure; LVDP, left ventricular diastolic pressure; RVSP, right ventricular systolic pressure; RVDP, right ventricular diastolic pressure. [0058] Induction of cardiac hypertrophy is dependent on the activity of ILK. Our results, showing hypertrophic induction by the activated ILK allele, as well as activity-dependent induction of MAPK, ERK1/2, and p70S6K phosphorylation, suggested that ILK-induced hypertrophy is dependent on ILK activity. In order to test this idea directly, we compared the hypertrophic status of hearts from transgenic mice expressing ILK WT , with hearts from ILK R211A transgenic mice. ILK WT hearts exhibited a hypertrophic phenotype which closely mimicked that of the ILK343D mutant, as evident by the significant (p<0.001) increase in HW:BW (Supplementary Table 4) and LV mass measured by echocardiography (p<0.001) in comparison to NTg littermate controls (Supplementary Table 5). Additionally, transgenic mice with cardiac-restricted expression of the kinase-inactive ILK construct (ILK R211A ) did not develop cardiac hypertrophy, as assessed by echocardiography at 4 months of age (Supplementary Table 6). The finding that cardiac over-expression of kinase-deficient ILK did not exhibit evidence of cardiac dysfunction suggests that the structural role of ILK is sufficient for maintenance of baseline ventricular function, whereas kinase activity is required for hypertrophic remodeling. The G-protein activation profile correlated with the cardiac phenotypic findings, featuring selective activation of Rac1 and Cdc42 in the ILK WT ( FIG. 6 ab ) and ILK S343D Tg (Supplementary FIG. 1 ) genotypes, both of which develop hypertrophy, in comparison to the kinase-inactive ILK R211A , which exhibits a cardiac phenotype indistinguishable from control. [0000] TABLE 4 Supplemental. Heart, lung, liver weights of ILK WT and ILK R211A transgenic mice Non- Transgenic Transgenic % Increase p-value ILK R211A (4 months) No. of mice n = 10 n = 5 Body weight (g)   24 ± 2.6   23 ± 3.2 4.3 NS Heart weight (mg) 112 ± 17 106 ± 17 5.7 NS Lung weight (mg) 220 ± 79 219 ± 63 0.5 NS Liver weight (mg) 1277 ± 199 1219 ± 119 4.8 NS Heart/Body weight  4.7 ± 0.5  4.6 ± 0.8 2.1 NS (mg/g) Lung/Body weight  9.2 ± 2.4  9.5 ± 3.5 −3.2 NS (mg/g) Liver/Body weight   53 ± 8.9  53 ± 11 0 NS (mg/g) ILK WT (4 weeks) No. of mice n = 5 n = 7 Body weight (g)   22 ± 2.1   22 ± 4.4 0.0 NS Heart weight (mg)  126 ± 8.2 106 ± 17 19 <0.05  Lung weight (mg) 238 ± 32 236 ± 32 0.8 NS Liver weight (mg) 1205 ± 190 1185 ± 170 1.7 NS Heart/Body weight  5.7 ± 0.43  4.8 ± 0.45 19 <0.001 (mg/g) Lung/Body weight   11 ± 1.2   11 ± 1.6 0.0 NS (mg/g) Liver/Body weight   55 ± 6.3   54 ± 4.9 1.9 NS (mg/g) [0000] TABLE 5 Supplemental. Echocardiography of ILK WT transgenic mice Transgenic Non-transgenic No. of mice n = 5 n = 8 LVEDAW (mm)  0.94 ± 0.09** 0.67 ± 0.09 LVEDD (mm) 3.75 ± 0.27  4.05 ± 0.32 LVEDPW (mm) 0.74 ± 0.11* 0.53 ± 0.09 LVESAW (mm) 1.30 ± 0.21* 0.92 ± 0.13 LVESD (mm) 2.48 ± 0.52  2.97 ± 0.37 LVESPW (mm) 0.99 ± 0.15* 0.76 ± 0.08 Vcf (mm/s) 20.63 ± 4.48  18.25 ± 3.60  % FS 34.41 ± 9.57  24.43 ± 6.75  Stroke Volume (mm 3 ) 2.35 ± 1.35  1.33 ± 0.45 LV Mass (mg 3 ) 112 ± 11** 83 ± 22 *p < 0.05, **p < 0.001, vs NTg littermates. [0000] TABLE 6 Supplemental. Echocardiography of ILK R211A transgenic mice Transgenic Non-transgenic 3 Weeks old No. of mice n = 7 n = 5 LVEDAW (mm) 0.76 ± 0.09 0.68 ± 0.11 LVEDD (mm) 3.60 ± 0.27 3.32 ± 0.19 LVEDPW (mm) 0.66 ± 0.08 0.63 ± 0.11 LVESAW (mm) 1.10 ± 0.05 1.05 ± 0.27 LVESD (mm) 2.31 ± 0.32 2.11 ± 0.53 LVESPW (mm) 1.01 ± 0.11 0.99 ± 0.12 Vcf (mm/s) 18.66 ± 5.20  18.81 ± 6.20  % FS 35.85 ± 6.50  36.70 ± 14.0  Stroke volume (mm 3 ) 2.30 ± 0.55 2.20 ± 0.83 LV Mass (mg 3 ) 78 ± 12 74 ± 10 4 Months old No. of mice n = 7 n = 3 LVEDAW (mm) 0.93 ± 0.08 0.96 ± 0.07 LVEDD (mm) 3.58 ± 0.25 3.76 ± 0.17 LVEDPW (mm) 0.75 ± 0.04 0.75 ± 0.05 LVESAW (mm) 1.28 ± 0.12 1.36 ± 0.11 LVESD (mm) 2.34 ± 0.30 2.47 ± 0.23 LVESPW (mm) 1.10 ± 0.11 1.14 ± 0.10 Vcf (mm/s) 19.94 ± 2.10  21.64 ± 3.40  % FS 35.36 ± 4.20  34.73 ± 4.20  Stroke Volume (mm 3 ) 2.07 ± 0.53 2.76 ± 1.0  LV Mass (mg 3 )  105 ± 11.5 117 ± 11  *p < 0.05, **p < 0.001, vs NTg littermates. [0059] We found that expression of either wild type ( FIG. 6 cd ) or constitutively active (Supplementary FIG. 2 ) ILK, but not ILK R211A , increased phosphorylation of both ERK1/2, and p38MAPK, indicating that activation of these kinases was dependent on ILK catalytic activity. Whereas increased expression of ILK was confirmed in both the ILK WT and ILK R211A genotypes ( FIG. 6 e ), phosphorylation-dependent activation of ILK targets, p70S6K, ERK1/2, p38MAPK, and the p38-dependent transcription factor, ATF2, was only evident in the wild-type over-expressing ventricles ( FIG. 6 cd ). Western blotting confirmed roughly equal expression levels from ILK WT and ILK R211A transgenes ( FIG. 6 e ), suggesting these differences were due to ILK catalytic activity. [0060] Acute ILK-dependent Rac1 activation in isolated human cardiomyocytes. In order to evaluate the effect of acute ILK up-regulation on GTPase activation, we infected human fetal cardiomyocytes with adenoviruses expressing ILK (Ad-ILK), or an empty virus control. Infection with Ad-ILK stimulated an 3-fold increase in levels of GTP-bound Rac1 and an ˜7-fold increase in GTP-bound Cdc42, 24 hours post-infection ( FIG. 7 ). These stimulations were blocked by treatment of the Ad-ILK infected cells with the small molecule ILK inhibitor, KP-392, suggesting that ILK kinase activity is required for activation of these small GTPases. Infection of the cardiomyocytes with empty adenovirus, carrying no ILK sequences, had no effect on the activation state of Rac1, Cdc42, or RhoA. These results indicate that, as in the transgenic mouse hearts and during human hypertrophy caused by mechanical loading, acute up-regulation of ILK in isolated cardiomyocytes directly activates Rac1 and Cdc42. [0061] Genetic ILK over-expression enhances post-infarction remodeling. In order to test for potential cardioprotective effects of ILK, we analyzed LV infarct size in aged 6 month ILK TgS343D and littermate control mice at 7 days post-LAD ligation, based on planimetric scar dimensions measured in six levels of cross-sections of the LV ( FIG. 8 ). The ILK TgS343D genotype exhibited a significantly greater LV mass (p=0.01), a trend towards reduction in absolute LV scar area (p=0.106), and a reduction in scar area indexed to LV mass (p=0.047) ( FIG. 8 b ). Thus, cardiac ILK activation resulted in a post-infarction remodeling phenotype featuring a reactive increase in LV mass. [0062] Recent studies have challenged the traditional thinking that the adult mammalian heart lacks inherent regenerative capacity. Cardiac stem cells (CSCs) derived from bone marrow or niches within the heart have been identified and shown to participate in the regeneration of myocardium in vivo xii,xiii,xiv . Tissue-resident cardiac progenitor cells expressing various stem cell markers such as Sca-1, MDR-1, and c-Kit, exhibit the hallmarks of adult stem cells: self-renewal, clonogenicity, and multi-lineage differentiation. However, the population of progenitor cells in the heart is very low, and the inability to expand this population of cells in vitro or in vivo represents a major barrier to therapeutic stem cell applications. [0063] Integrin-linked kinase (ILK) is a multi-functional protein kinase, which coordinates signal transduction by integrins and growth factor receptors, and serves as a nodal regulator of protein kinase cascades important to cell proliferation, differentiation and apoptosis xv,xvi . ILK functions as the effector of phosphoinositide-3′-OH kinase (PI3K) signaling following distinct signal inputs from integrins and growth factor receptor tyrosine kinases xvii,xviii . ILK also inhibits glycogen synthase kinase-3β (GSK-3β) xvi,xix , which leads to the nuclear accumulation of β-catenin, which, in turn, leads to the activation of Wnt target genes implicated in the maintenance and symmetric replication of embryonic stem cells, as well as their more tissue- and lineage-restricted progeny. The canonical Wnt/β-catenin signaling pathway has been shown to be important in both embryonic and adult stem cell maintenance and self-renewal in hematopoetic, gastrointestinal and neural tissues xx,xxi,xxii,xxiii,xxiv,xxv , although this pathway has not been studied in CSCs. [0064] The demonstrable utility of Integrin-linked kinase (ILK) to promote cardiac stem cell proliferation and self renewal is herein set forth. While it was known that Integrin-linked kinase (ILK) is a multi-functional protein kinase, which coordinates signal transduction by integrins and growth factor receptors, and activates Wnt target genes implicated in the maintenance and symmetric replication of embryonic stem cells, the effect of ILK on cardiac stem cells has been heretofore unknown. [0065] Recent evidence suggests that the adult heart contains stem cells, which are capable of self-renewal as well as tissue-specific, multi-lineage differentiation. However, their inherent capacity for self-renewal is limiting to cell replacement applications. We herein demonstrate that a cardiac stem cell population is susceptible to amplification through ILK gain-of-function. Methods: [0066] Primary cultures derived from human fetal cardiac tissue (19-22 weeks gestation) were grown in serum-free media supplemented with growth factors and evaluated for the appearance of cells with the properties of stem cells, including self-renewal and the capacity to differentiate into definitive cardiac myocytes. The effect of ILK was ascertained using adenoviral over-expression of ILK cDNA constructs conveying either gain- or loss-of-function. Results: [0067] Cultures infected with wild type ILK yielded a significant (p=0.001), ˜5-fold increase in both the absolute number and the frequency of c-Kit POS , myosin NEG cells, which reached ˜one cell in 250. Cardiospheres (CS), comprised on morphologically homogeneous, anchorage-independent cells, were reproducibly present at day 7-10, and formed derivative CS in multiple passages. ILK infection of primary cardiac cell cultures resulted in a greater number of primary spheres at each cell density tested, compared with untreated and virus controls (p=0.001). Secondary spheres transferred to differentiation medium consisting of IMDM with 10% FBS and 5-Aza-deoxycytodine (10 uM) generated cells exhibiting biochemical evidence of differentiation into cardiomyocytes, smooth muscle cells and endothelial cells. CONCLUSIONS [0068] This study demonstrates that self-renewing cardiospheres generated from human fetal cardiac cells are comprised of cells exhibiting the properties of stem cells, including the capacity for self-renewal and multilineage differentiation. ILK-transformed stem cells are shown to be equally susceptible to cardiac differentiation, even while exhibiting an increased capacity for proliferation and CS formation. Our results suggest that ILK promotes stem cell amplification and can be applied therapeutically to overcome a major limitation in the field of cardiac regenerative medicine. [0069] Here we show that the overexpression of ILK in human fetal cardiac tissue in vitro increases the population of cardiac stem cells, which exhibit self-renewal and multi-lineage differentiation. Our results suggest that gain-of-function of a gene which promotes stem cell amplification can be applied therapeutically to overcome a major limitation in the field of regenerative medicine. DETAILED DESCRIPTION OF EXPERIMENTS Isolation and Cell Culture [0070] Human fetal hearts were harvested during elective pregnancy termination at the gestational ages of 19 to 22 weeks, in accordance with the guidelines of the Institutional Human Research Ethics Board and after obtaining maternal consent. [0071] The hearts were minced and washed using phosphate buffered saline (PBS). Cell isolation was accomplished using 0.2% trypsin and 1.0 mg/mL type II collagenase in a 0.02% glucose PBS solution at 37° C. After dissection, cells were incubated on pre-coated plastic culture dishes (Starstedt) for 2 hours at 37° C. to remove fibroblasts, with IMDM (Gibco) containing Penicillin and Streptomycin and supplemented with 10% fetal bovine serum (Gibco). After incubation, the supernatant was removed and added to pre-coated culture dishes (Starstedt) and placed in a 5% CO2 incubator at 37° C. Gene Transfer [0072] Cells were cultured to 60-70% confluency in preparation for adenovirally-mediated infection of ILK constructs incorporating green fluorescent protein (GFP), as previously described xxvi . Replication-deficient serotype 5 adenovirus encoding either the human wild-type ILK gene (Ad.ILK-GFP) or empty virus constructs (Ad.C) previously shown to modulate ILK expression and activity in L6 myoblasts xxvii , were used for the infection of cells. Cells were infected at 37° C. at multiplicity of infection of 1.5 in IMDM medium with 10% fetal bovine serum for 24 h. Effective gene transfer was confirmed by more than 80% of GFP positivity. Western Blot Analysis [0073] Western blot analysis was performed to confirm that the transduction of Ad.ILK in cardiac cell cultures. The cells were washed with PBS and harvested by scraping in lysis buffer. After measurement of protein expression, analyses were performed with polyclonal anti-ILK antibody (Cell Signaling). Proteins were visualized with an enhanced chemiluminescence (ECL) detection reagent (Amersham Pharmacia Biotech) and quantified by densitometry. [0000] Immunocytochemistry and Quantitative Analysis of c-Kit POS Cells [0074] Cells were fixed using methanol at −20° C. for 20 minutes. Cells were then reacted with c-Kit antibody (diluted 1:20; Assay Design Inc.), human monoclonal anti-CD34 (Cymbus Biotechnology), human monoclonal anti-α-smooth muscle actin (1:100; Santa Cruz), human polyclonal anti-Von Willebrand Factor (1:200), myosin monoclonal antibody (MF20 diluted 1:10), or monoclonal anti-α actinin (1:200) from Sigma. Nuclei were stained with DAPI. All slides were analyzed at 20× magnification using a Leica fluorescent microscope with a coupled camera. All analysis was done using Openlab 4.0.2 software. More than ten fields were randomly chosen and photographed, and the total cell number (˜5000/dish) was counted manually in a fashion blinded to viral status. Generation of Primary and Secondary Spheres [0075] Cell viability of cells was confirmed with trypan blue staining prior to plating at densities from 10 cells/μL to 1 cell/μL in 24-well plates. The culture medium was composed of DMEM/F-12 (1:1) including Hepes buffer (5 mM), glucose (0.6%), sodium bicarbonate (3 mM), and glutamine (2 mM), insulin (25 μg/ml), transferrin (100 μg/ml), progesterone (20 nM), putrescine (60 μM), sodium selenite (30 nM), human recombinant EGF (20 ng/ml), and bFGF (20 ng/ml). The number of primary spheres generated in each well was assessed 14 days after plating. Primary spheres were dissociated into single cells consisting of 200-500 cells, which were placed in 96-well plates. The number of secondary spheres was assessed 14 days after replating dissociated cells. Differentiation Assay [0076] Secondary spheres were transferred to differentiation medium, which was composed of IMDM containing 10% FBS and 10 uM 5-aza-2′-deoxycytodine (5azaD). Cells migrating out from the spheres were analyzed by immunocytochemistry on day 14. Cells were fixed and characterized by staining with the following markers: α-cardiac actinin antibody (diluted 1:100, SIGMA), Von Willebrand factor antibody (diluted 1:200 DAKO), or α-smooth muscle actin antibody (diluted 1:100, Santa Cruz). Results [0077] ILK Increases the Frequency of c-Kit POS Cells [0078] To determine whether the overexpression of ILK increases the stem cell number in the human heart, fetal hearts of gestational ages 19-22 weeks were acquired during elective pregnancy termination, and the hearts were enzymatically dissociated into single cell suspension. The cells were incubated on pre-coated plastic culture dishes for 2 hours at 37° C. to remove fibroblasts, which were shown to be devoid of c-Kit POS cells. At 2-3 days after isolation and at 60-70% confluency, cells were infected with replication defective adenovirus containing wild type (Ad.ILK), or virus control (Ad.C). Effective gene transfer was confirmed by more than 80% GFP positivity ( FIG. 1 a ) and by ˜3-fold increase in ILK protein expression ( FIG. 1 b ) in cell cultures. c-Kit POS cells imaged by fluorescence microscopy were invariably negative for the cardiac myosin markers α-cardiac actinin ( FIG. 1 c ), MF20 and the hematopoetic stem cell marker CD34. Cultures infected with wild type ILK yielded a significant (p=0.001), ˜5-fold increase in both the absolute number and the frequency of c-Kit POS cells, which reached ˜one cell in 250 ( FIG. 1 d ). Human Fetal Cardiac Cells Generate Cardiospheres In Vitro [0079] To determine if primary human fetal cardiac cells generate cardiospheres in vitro, cells were infected with Ad.ILK or control virus and plated in serum-free medium supplemented with 20 ng/ml each of EGF and bFGF at clonal density of a single cell per well in 24-well plates. Primary cardiospheres (CS), comprised on morphologically homogeneous cells, were reproducibly present at day 7-10 ( FIG. 2 , upper panel). CS were noted to be uniformly free-floating, presumably reflecting anchorage-independence, in distinction to cardiac myocytes which became rapidly adherent to the culture plate surface. Cells from dissociated primary CS were plated at a density corresponding to one sphere (˜200-400 cells)/well. Secondary CS, which were morphologically indistinguishable from primary CS, were evident in ˜60% of wells at day 14 ( FIG. 2 , lower panel). CS were shown to be comprised of cells expressing the c-Kit POS surface receptor ( FIG. 3 ). Occasional cells at the periphery of the spheres stained for the cardiac marker α-actinin (arrowhead). ILK Over-Expression Increases the Rate of CS Formation [0080] ILK infection of primary cardiac cell cultures resulted in a greater number of primary spheres at each cell density tested, compared with untreated and virus controls ( FIG. 4 a ). Among CS generated from ILK-infected cultures, ˜80% stained homogeneously for ILK-GFP; ˜20% exhibited no evidence of GFP staining; and no spheres were observed which were mosaic for GFP, suggesting origin from a single cell rather than cellular aggregation. The frequency of sphere-initiating cells, as measured by the ratio of sphere number:total cell number, was significantly greater in ILK-overexpressing cultures ( FIG. 4 b ). The frequency of secondary or tertiary spheres generated from primary spheres comprised of Ad.ILK, AD.C or uninfected cells was highly similar (˜60% of wells), indicating that while ILK gain-of-function increases the formation of primary spheres, it does not alter their inherent capacity for subsequent self-renewal. [0081] Cardiac stem cells are multipotent and have the capacity to differentiate into smooth muscle, cardiac and endothelial cells xxx,xxxi,xxxii . Secondary spheres were transferred to differentiation medium consisting of IMDM with 10% FBS and the methyltransferase inhibitor, 5azaD (10 uM). Within 4-5 days spheres became attached to the plate and individual cells migrated from spheres, which exhibited biochemical evidence of differentiation into cardiomyocytes, smooth muscle cells and endothelial cells ( FIG. 5 ). The profile of differentiated cells among ILK-over expressing and control cells was highly similar ( FIG. 5 , lower left panel), indicating that ILK-induced clonal proliferation of cardiac stem cells does not impair their capacity for multilineage differentiation. Discussion [0082] These experiments show that primary cultures derived from human fetal cardiac tissue grown in non-serum, growth factor-supplemented media form macroscopic cardiopsheres, analogous to neurospheres containing multipotent neural stem cells xxviii,xxix . Cardiospheres (CS) have been previously characterized as lineage-negative (Lin NEG ) c-Kit POS , morphologically homogeneous cells devoid of cardiac markers such as sarcomeric structures, having the capacity for self-renewal, as well as differentiation into functional cardiac myocytes, and to participate in the regeneration of functional myocardium in vivo xxx,xxxi,xxxii . Cells comprising CS did not express the hematopoetic stem cell marker CD34, suggesting that CS were derived from a cardiac resident, rather than from a bone marrow-mobilised, cell population xxxiii . [0083] The evolutionarily conserved canonical Wnt pathway has been implicated in both human and mouse ES cell self-renewal competence xxii . The Wnt/β-catenin signaling pathway is required for maintaining proliferation of neuronal progenitors xxiii , and for haematopoietic stem cell homeostasis xxv . ILK negatively modulates of GSK-3β activity and promotes nuclear activation of β-catenin xxiii,xxxiv,xxxv,xxxvi,xxxvii , and is a candidate kinase activator of Wnt pathway signaling xvi . ILK over-expression or constitutive activation promotes cell cycle transit through a signaling pathway comprising the Wnt components GSK-3β and β-catenin, leading to increased expression of cyclin D1 xxxviii , and providing a molecular basis for the inherent proliferation (self-renewal) property of stem cells. Moreover, ILK promotes anchorage-independent survival, which appears to be a generic and poorly understood feature of stem cells, including c-Kit-containing CS isolated from adult rat xxix and human hearts xl . [0084] These experiments validate our initial theory that human fetal cardiac tissue would be enriched for stem cells, which are important during cardiogenesis xli . Since it has been reported that cardiac c-Kit positive cells can grow and differentiate into the various cardiac lineages, including cardiomyocytes, smooth muscle and endothelial cells xiv , c-Kit antibody was used as a marker for cardiac stem cells. The proto-oncogene c-kit encodes a transmembrane tyrosine kinase receptor, and the ligand for c-Kit has been identified to be stem cell factor (SCF) xlii . We took advantage of the tendency of cardiac cells to form macroscopic CS when grown on non-adhesive substrata in the presence of growth factor supplementation. Using the capacity to form CS as a readout for stem cell frequency, we tested whether adenoviral ILK overexpression would cause proliferation of CS-forming cells with self-renewal, clonogenic, and multi-differentiation properties. [0085] We have thus demonstrated that self-renewing cardiospheres generated from human fetal cardiac cells are comprised of cells exhibiting the properties of stem cells, including the capacity for self-renewal and multilineage differentiation. This result has been also reported in cardiac cells isolated from adult rodent xxx , murine xxxii , and human atrial biopsies xxxi . Overexpression of ILK resulted in an ˜10-fold increase in the frequency of sphere-initiating cells. Importantly, ILK-transformed stem cells are shown to be equally susceptible to cardiac differentiation, even while exhibiting an increased capacity for proliferation and CS formation. [0086] ILK is positioned to transduce distinct signal inputs from integrins and growth factor receptor tyrosine kinases xlii,xliv , is an activator of the Wnt pathway xlv , and promotes anchorage-independent cellular proliferation xvi,xviii , thus providing a putative molecular basis for the observed amplification effect on the cardiac stem cell population. An ILK-dependent increase in cardiac stem cell frequency is consistent with the finding that vascular endothelial growth factor (VEGF) has been shown to positively regulate hematopoetic stem cell survival xlvi , since ILK positively regulates VEGF expression through an hypoxia-inducible factor-1α-dependent pathway xv . The fact that ILK effect was evident even under conditions of growth factor supplementation supports the rationale of exploiting upregulation the ILK signaling pathway as a novel strategy to promote therapeutically useful expansion of a target stem cell population. [0087] 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. [0088] 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 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 any drawings/figures included herein. [0089] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, 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. 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Nature Neuroscience. 2005; 8:723-729. xxx Beltrami A P, Urbanek K, Leri A, Kajstura J, Nadal-Ginard B, Anversa P. Adult cardiac stem cells are multipotent and support myocardial regeneration. Cell. 2003; 114:763-776. xxxl Messina E, De Angelis L, Frati G, Morrone S, Chimenti S, Fiordaliso F, et al. Isolation and expansion of adult cardiac stem cells from human and murine heart. Circ Res. 2004; 95:911-921. xxxli Matsuura K, Komuro I. Adult cardiac Sca-1-positive cells differentiate into beating cardiomyocytes. J Biol Chem. 2004; 279:11384-11391. xxxlli Araki H, Mahmud N, Milhem M, Nunez R, Xu M, Beam C A, et al Expansion of human umbilical cord blood SCID-repopulating cells using chromatin-modifying agents. Exp Hematol. 2006; 34:140-149. xxxiv Novak A, Dedhar S. Signaling through beta-catenin and Lef/Tcf. Cell Mol Life Sci. 1999; 56:523-537. xxxv Novak A, Dedhar S. Cell adhesion and the integrin-linked kinase regulate the LEF-1 and beta-catenin signaling pathways. Proc Natl Acad Sci USA. 1998; 5:437-4379. xxxvi Xie D, Yin D, Tong X, O'Kelly J, Mori A, Miller C, et al. Cyr61 is overexpressed in gliomas and involved in integrin-linked kinase-mediated Akt and beta-catenin-TCF/Lef signaling pathways. Cancer Res. 2004; 64:1987-1996. xxxvii Tan C, Dedhar S. Inhibition of integrin linked kinase (ILK) suppresses beta-catenin-Lef/Tcf-dependent transcription and expression of the E-cadherin repressor, snail, in APC−/−human colon carcinoma cells. Oncogene. 2001; 20:133-140. xxxviii Kumar A S, Naruszewiez I, Wang P, Leung-Hagesteijn C, Hannigan G E. ILKAP regulates ILK signaling and inhibits anchorage-independent growth. Oncogene. 2004; 23:3454-3461. xxxix Beltrami A P, Barlucchi L, Torella D, Baker M, Limana F, Chimenti S, et al. Adult cardiac stem cells are multipotent and support myocardial regeneration. Cell. 2003; 114:763-776. xl Messina E, De Angelis L, Frati G, Morrone S, Chimenti S, Fiordaliso F, et al. Isolation and expansion of adult cardiac stem cells from human and murine heart. Circ Res. 2004; 95:911-921. xli Laugwitz K L, Moretti A, Lam J, Gruber P, Chen A, Woodard S, et al. Postnatal isl1+cardioblasts enter fully differentiated cardiomyocyte lineages. Nature. 2005; 433:647-653. xlii Yamataka A, Ohshiro K, Kobayashi E, Lane G J, Yamataka T, Fujiwara T, et al. Abnormal distribution of intestinal pacemaker (C-KIT-positive) cells in an infant with chronic idiopathic intestinal pseudoobstruction. J Pediatr Surg. 1998; 33:859-862. xliii Troussard A A, Tan C, Yoganathan N, Dedhar S. Cell-extracellular matrix interactions stimulate the AP-1 transcription factor in an integrin-linked kinase- and glycogen synthase kinase 3-dependent manner. Mol Cell Biol. 1999; 19:7420-7427. xliv Persad S, Attwell S, Gray V, Delcommenne M, Troussard A, Saughera J, et al. Inhibition of integrin-linked kinase (LK) suppresses activation of protein kinase B/Akt and induces cell cycle arrest and apoptosis of PTEN-mutant prostate cancer cells. Proc Natl Acad Sci USA. 2000; 97:3207-3212. xlv Troussard A A, Mawji N M, Ong C, Mui A, St-Arnaud R, Dedhar S. Conditional knock-out of integrin-linked kinase demonstrates an essential role in protein kinase B/Akt activation. J Biol Chem. 2003; 278:22374-22378. xlvi Gerber H P, Malik A K, Solar G P, Sherman D, Liang X H, Meng G, et al. VEGF regulates haematopoietic stem cell survival by an internal autocrine loop mechanism. Nature 2002; 417:954-958.

1a

BACKGROUND OF THE INVENTION [0001] This invention relates to a smoking article which includes a catalyst bed therein and more particularly to a smoking article which reforms the mainstream smoke of a smoking article by heating a selected catalyst disposed within the smoking article. [0002] In the combustion of tobacco in a smoking article, many difference gaseous constituents are released during the combustion. Some of these gaseous components are toxic, others are not. Most cigarette products include a cellulose acetate filter on the mouth end of the cigarettes to remove a substantial percentage of the solid particulates as well as the removal of a large quantity of condensing gases evolved from the combustion of the tobacco. It is also become common place to use activated charcoal in combination with a cellulose acetate filter for the removal of noxious gases and particulate materials in the smoke stream. [0003] In U.S. Pat. No. 5,657,772 to Duke et al, Duke et al teaches a filter for a smoking article which incorporates particles coated with platinum for reducing selective volatiles which are present in the mainstream smoke in a smoking article. Moreover, in U.S. Pat. No. 5,211,684 to Shannon et al, a smoking article is taught which contains a catalytic composition as part of the fuel element for reducing carbon monoxide in mainstream smoke from combustion of tobacco in a smoking article. SUMMARY OF THE INVENTION [0004] It is an object of the present invention to provide a smoking article which includes a catalytic smoke reformer therein. [0005] It is another object of the present invention to provide a smoking article which uses a catalyst as a distinct component of the smoking article which is heated slightly above ambient temperature in order to enhance smoke reformer activity. [0006] It is even a further object to use catalytic combustion of whole smoke as the heat source for aerosol formation and thereby generate a chemically simple smoke for a consumer. [0007] It is also an object to use a catalyst in a cigarette to combust carbon monoxide. [0008] More particularly, the present invention provides a smoking article which includes a tobacco rod in axial alignment with a filter section with a catalyst bed disposed between the tobacco rod and the filter section, the catalyst bed being maintained at a preselected temperature above 100° C. [0009] In the present invention, a cooling chamber may be disposed between the catalyst bed and the filter and the catalyst bed may be in heat communication with a heating source, such as a heating pad which circumscribes the catalyst, or the tobacco rod may be provided with a centrally disposed channel therein which extends the longitudinal length of the tobacco rod for providing heating smoke or smoke at an elevated temperature of at least 100° C. as the means for providing heat to the catalyst bed. The portable heating pad usually consists of a self-sustaining solid-solid or a solid-liquid exothermic reactor which is packed in a disposable wrapper that envelopes a catalyst bed. Even further, flavorings may be added to the smoking article and in one particular embodiment may be disposed between the catalyst bed and the filter section. BRIEF DESCRIPTION OF THE DRAWINGS [0010] A better understanding of the invention will be had upon reference to the following description in conjunction with the accompanying drawings in which like numerals refer to like parts throughout the several views and wherein: [0011] FIG. 1 is a perspective view of one preferred embodiment of the smoking article of the present invention; [0012] FIG. 2 is a cross-sectional side elevation of the smoking article of FIG. 1 ; [0013] FIG. 3 is a cross-sectional view of a second embodiment of the present invention; [0014] FIG. 4 is a cross-sectional view of a third embodiment of the present invention; and, [0015] FIG. 5 is a cross-sectional view of a fourth embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0016] As shown in FIGS. 1 and 2 , a smoking article 10 is comprised of a tobacco section 12 , a heated catalysis section 14 , a cooling section 16 , and a filter section 18 . A cigarette wrapper 22 encases tobacco 32 and extends towards the mouth end of the cigarette. Cigarette wrapper 22 also encases a cooling chamber 36 adjacent to the filter section 18 . An external heat source, such as a heating pad 22 , circumscribes the catalyst bed 34 . The portable heating pad 24 generally includes a self-sustaining solid-solid or solid-liquid exothermic reactor packed in a disposable wrapper. The catalyst bed 34 is generally in the form of meshes, honeycombed structures, granules, and the like. The particular catalyst for making up the meshes or honeycombed structures is determined by the specific smoke components which are to be reformed. The ability to alter specific smoke components depends on the nature of the catalyst, the effective surface area of the catalyst, and its surface temperature. For example, oxidation/reduction catalyst reduce NOx and oxide CO. Low temperature CO oxidation catalyst include base and noble metal oxides. Platinum and/or palladium metals and metal alloys coated on metal substrates are usable for oxidation-reduction catalyst. The degree of conversion of the smoke components depends on the specific type catalyst and reaction temperature employed. Depending upon the desired extent of smoke chemistry modification, the catalyst bed may include a plurality of different types of catalysts. [0017] In the smoking of a smoking article, as set forth in FIGS. 1 and 2 , the lighting end or tobacco end of the smoking article 10 is lit and the smoke passes from the tobacco section 12 into the catalyst section 14 which is heated by a heating pad 24 to at least 100° C. and controlled in a desired temperature range wherein selected smoke components reform as they pass through the catalyst bed 34 . The mainstream smoke, including the reformed smoke components, is then cooled in the cooling section 16 prior to entering the filter section 18 . In the filter section 18 , the particulates and condensible materials are removed from the smoke stream prior to entering the mouth of the smoker. [0018] In FIG. 3 is shown a second embodiment of the present invention wherein a smoking article 110 differs from the smoking article 10 in that a flavor section 116 is disposed between the heated catalyst section 14 and the filter section 18 . The flavor section 116 includes a flavor source 136 which may be tobacco or any other flavor source which will be vaporized upon contact with the mainstream smoke which is the by-product of combustion of the tobacco 32 in the tobacco section 12 . [0019] In FIG. 4 is shown a smoking article 210 which differs from the smoking article 10 and 110 of FIGS. 2 and 3 , respectively, in that the tobacco section 212 is provided with tobacco 232 and a central hollow section 242 which extends from the terminating or lighting end of tobacco section 212 to the catalyst bed 234 . The mainstream smoke from the tobacco section 212 flows through the channel 242 and upon contacting the catalyst bed 234 , catalytic after-burning takes place resulting in the oxidation of CO and reduction of NOx. The quality of the reform smoke depends, however, on the specific catalyst and its temperature. [0020] In FIG. 5 is another embodiment of the present invention. The smoking article 310 is a modification of the smoking article 210 of FIG. 4 wherein a flavor section 116 , including a flavor source, such as tobacco 136 , is disposed between the catalyst 234 and the filter section 18 . [0021] The foregoing detailed description is given primarily for clearness of understanding and no unnecessary limitations are to be understood therefrom for modifications will become obvious to those skilled in the art upon reading this disclosure and may be made without departing from the spirit of the invention and scope of the appended claims.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention generally relates to interactive game play and more specifically to the ranking of advice rendered to aid a user with interactive game play. [0003] 2. Description of the Related Art [0004] Improvements in processing power and graphics quality have lead to increasingly complex interactive gaming environments. For example, the PlayStation®3's RSX graphics processor allows for freedom of graphics expression in creating next-generation, real-time 3D imagery. Working in tandem with Sony Computer Entertainment Inc's Cell Broadband Engine™ Architecture, RSX processor rendered graphics are unparalleled in quality and realism. [0005] Increasingly complex gaming environments have, in turn, resulted in more complex story lines, game play objectives, missions and tasks, and capabilities associated with game play avatars. As a result, interactive game play has become more challenging even for experienced game players. If a game becomes too challenging, however, game players may forsake future game play out of frustration. [0006] To help game players overcome obstacles or achieve goals in a variety of interactive games, various content providers have begun publishing game magazines. These magazines provide game players with a ‘walk thru’ that tell the reader/game player where to go and what to do in order to ‘win’ the game or obtain the highest possible score. Hints or suggestions with respect to special moves or avatar capabilities may also be described in these gaming magazines. [0007] While these magazines may be informative, they suffer from a number of drawbacks. If the magazine is not published by an official source (e.g., an official partner of the game developer), the magazine may omit essential information. In some instances, an unofficial magazine may publish, incorrect information. Incorrect information may also result from the tendency to rush and publish these magazines concurrently with the release of an interactive game title to allow for concurrent purchase—even if the magazine is published by an official source. [0008] Game players may also discover ‘Easter Eggs’ or other secrets during the course of game play. These secrets may not be a part of even an official magazine due to the fact that some game design engineers ‘slip in’ these Easter Eggs without the knowledge of the magazine publisher. Many interactive games also allow for the creation of special moves that may not have initially been conceived of by the game developer. As a result, these special moves are not a part of the game play magazine—official or otherwise—as their development occur after the magazine and associated game has gone to market. [0009] Once game play magazines publish, subsequent editions tend not to be published. The lack of subsequent, updated editions may further the information that may be withheld from game players. Unique game play situations or circumstances may not become apparent until the interactive game is played by a large number of game players. These situations and circumstances may not be addressed in the gaming magazine thereby leaving game players at a loss as to how they may properly address the same. [0010] In contrast, the internet offers the opportunity for endless publishing and republishing of information. If a particular solution is not offered in a game magazine, that solution may subsequently be published on the Internet. [0011] Notwithstanding endless publishing possibilities, websites on the Internet are often decentralized and unorganized. In some instances, there is no ‘official website’ as game developers may wish for game players to purchase a ‘for fee’ official magazine rather than access a free on-line website. Additionally, one website may offer one solution for one particular game play situation whereas another website may offer a solution for another situation. In order for a game player to obtain a complete ‘walk thru’ of a particular interactive game, the user may have to visit multiple websites on the Internet. Since these websites tend to be ‘unofficial,’ there is often an issue with the veracity or accuracy of the information displayed on these websites. [0012] There is a need in the art for game play advice that is complete and up-to-date regardless of when a particular interactive gaming title is released. Further, there is a need for game play advice that is pervasive and easily accessible to game players. There is also a need for game play advice that is accurate and credible such that game players can trust or rely upon the rendered advice. SUMMARY OF THE INVENTION [0013] Embodiments of the present invention provide a system and methods for managing user-generated game play advice. [0014] In one exemplary embodiment, a method for managing user-generated game play advice includes receiving new game play advice from a user. The new game play advice is displayed to a community of users. The new game play advice is initially displayed in a default ranking position. Display of the new game play advice occurs in conjunction with previously received game play advice. Feedback associated with the quality of the new game play advice and/or the previously received game play advice is received from the community of users. The new game play advice is ranked against the previously received game play advice based on the feedback received from the community of users. The new game play advice is then (redisplayed in conjunction with the previously received game play advice. The (re)display of the new game play advice and previously received game play device occurs in accordance with the ranking of the new game play advice and the previously received game play advice and without the default ranking initially allocated to the new game play advice. [0015] In another exemplary embodiment, a system for managing user-generate game play advice is provided. The exemplary system includes a game play advice submission engine. The game play advice submission engine receives game play advice submissions over a network; the submissions are allocated a ranking by a ranking engine. A game play advice display engine displays game play advice submissions in accordance with a ranking allocated by the ranking engine. A feedback engine receives feedback from a community of users with respect to the quality of the game play advice displayed by the game play advice display engine. The feedback engine and the ranking engine operate to allocate anew ranking to the game play advice in accordance with the feedback received from the community of users. The game play advice is subsequently displayed by the game play advice display engine in accordance with the new ranking. [0016] A further exemplary embodiment provides for a method for displaying user-generated game play advice. In the present exemplary method, new game play advice is received from a first user, that user having previously received feedback from a community of users. The new game play advice is ranked against previously received game play advice. The previously received game play advice has been submitted by at least a second user that has previously received feedback from the community of users. The new game play advice is ranked against the previously received game play advice based on the user feedback received from the community of users. The new game play advice is displayed in conjunction with the previously received game play advice. The new game play advice and the previously received game play advice are displayed in accordance with the ranking of the new game play advice and the previously received game play advice. [0017] A still further embodiment provides for a method for managing user-generated game play advice where new game play advice is received from a user. The new game play advice is displayed to a community of users. The new game play advice is initially displayed in a default ranking position. Display of the new game play advice occurs in conjunction with previously received game play advice. The user submitting the advice receives feedback from a community of users as does another user, that user having previously received feedback from the community of users. Feedback associated with the quality of the new game play advice and/or the previously received game play advice is also received from the community of users. A weighting value is assigned to the user feedback and the feedback associated with the quality of the game play advice. The new game play advice is ranked against the previously received game play advice based on the user feedback received from the community of users in addition to feedback associated with the quality of the game play advice. The ranking occurs in accordance with the weighting values assigned to the user feedback and feedback associated with the quality of the game play advice. The new game play advice is displayed in conjunction with the previously received game play advice and in accordance with the ranking of the new game play advice and the previously received game play advice. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 illustrates an exemplary system for ranking and managing user-generated game play advice. [0019] FIG. 2 illustrates an exemplary method for ranking user-generated game play advice based on the quality of the advice. [0020] FIG. 3 illustrates an exemplary method for ranking user-generated game play advice based on the reputation of the user submitting the advice. [0021] FIG. 4 illustrates an exemplary method for ranking user-generated game play advice based on the quality of the advice and the reputation of the user submitting the advice. [0022] FIG. 5A illustrates an exemplary ladder ranking of user-generated game play advice. [0023] FIG. 5B illustrates an exemplary three-dimensional virtual environment that may be used in conjunction with the display of user-generated game play advice. [0024] FIG. 5C illustrates another view of an exemplary three-dimensional virtual environment that may be used in conjunction with the display of user-generated game play advice like that shown in FIG. 5B . DETAILED DESCRIPTION [0025] The elements identified throughout are exemplary and may include various alternatives, equivalents, or derivations thereof. Various combinations of hardware, software, and computer-executable instructions may be utilized. Program modules and engines may include routines, programs, objects, components, and data structures that effectuate the performance of particular tasks when executed by a processor, which may be general purpose or application specific. Computer-executable instructions and associated data structures stored in a computer-read able storage medium represent examples of programming means for executing the steps of the methods and/or implementing particular system configurations disclosed herein. [0026] FIG. 1 illustrates an exemplary system 100 for ranking and managing user-generated game play advice. The system 100 of FIG. 1 includes a game play advice submission engine 120 , game play advice database 130 , ranking engine 140 , game play advice display engine 150 , feedback engine 160 , feedback database 170 , and ranking database 180 . In some embodiments (like that illustrated in FIG. 1 ), the system 100 may also include an optional weighting engine 190 . While various engines and databases are described in the context of FIG. 1 , an embodiment of the present invention may offer the functionality of each or certain of these engines and databases in a single ‘game play advice management’ engine or database. [0027] System 100 may be implemented in a network environment 110 such as the Internet, a proprietary communications environment, or a combination of the two. In one example, system 100 is an integrated component of the Playstation® Network. System 100 (or components thereof) may communicate with the network environment 110 utilizing any number of network interfaces as are known in the art. Examples of such interfaces include a 1000BASE-T Ethernet port or an IEEE 802.11 b/g network WiFi interface. [0028] System 100 may be implemented in a computing device such as a server dedicated to managing user-generated game play advice including maintenance of various databases. Alternatively, system 100 may be implemented in a computing device hosting a number of applications such as community maintenance, admission, and network game data distribution. System 100 may be dedicated to a single network game, a genre of games, or any number of games having no particular affiliation at all. [0029] System 100 may also be implemented in a distributed peer-to-peer environment. In such an implementation, certain, applications and/or responsibilities may be managed by a group of computing devices in the environment. A first computing may be represented by a game platform such as the PlayStation®3. This particular computing device may be responsible for ranking operations that take place via a ranking engine and maintaining a database of related information. A second computing device such as a desktop or laptop computer may be responsible for feedback operations that take place via a feedback engine and maintaining a database of related information. [0030] Various engines may be distributed to a community of users (e.g., players of a particular game or users in a general gaming network) through a push operation from a tasked server in the game community. Alternatively, various engines may be embodied in a computer-readable storage medium that also includes a particular game application (e.g., a disc). Distributed applications and engines may communicate directly via a group of peers or may be administered by a management server. [0031] Game play advice submission engine 120 is configured to allow a user to communicate with the system 100 over network 110 for submission of game play advice. Game play advice submission engine 120 may generate a user-interface for allowing user interaction with the system 100 . The interface may be a simple text-entry screen where users identify a game title, user identity (i.e., who is submitting the advice) in the form of a ‘real name’ or ‘screen name,’ and particular game play advice. [0032] Game play advice submission engine 120 may generate a ‘drop down’ menu to allow for easy entry of information. Drop-down menus may identify a variety of game titles (in order to maintain consistency of game title naming). Drop down menus may also allow for identification of particular types of advice such as special moves, Easter Eggs, unlocking weapons, or defeating particular enemies. Drop down menus may also identify particular portions of an interactive gaming environment by level or environmental description (e.g., Level 1 or ‘The Volcano’). Similar identification may occur with respect to particular objects, weapons, or enemies. [0033] Menus generated by the game play submission engine 120 may be level-based. A level-based menu configuration may cause the selection of one item at a first level of a menu to branch out into a series of options concerning a second level of related menu items. Selection of an entry at the second level may spawn a third-level and so on. Spawning of various levels may continue until there is no further information to be entered. [0034] Entry of the game play advice may be textual where a user enters a written description of the game play advice (e.g., ‘at the castle gate, look behind the statute for a hidden treasure’). Text-entry may occur through a virtual keyboard manipulated by a game controller coupled to a gaming platform. The gaming platform, in turn, is coupled to the system 100 via network 110 . Submission of game play advice may be audible and provided by speaking into a USB microphone headset. In some embodiments, video clips or still-frame images of game play may be submitted in the context of or as game play advice. Combinations of game play advice submissions are also within the scope of the present invention (e.g., a video clip with audible narration). [0035] Game play advice database 130 is configured to manage user-generated game play advice submitted through an interface generated by the submission engine 120 . Game play advice database 130 may manage submitted game play advice by user, game title, nature of the advice, date, size, content of the advice (e.g., video, audio, text, combinations of content), and so forth. Game play advice database 130 may include non-user generated game play advice (e.g., pre-stocked game play advice from the game publisher) that may also be ranked and displayed by system 100 . [0036] Game play advice database 130 may be configured to store all game play advice received through an interface generated by game play advice submission engine 120 . Alternatively, certain game play advice may expire over time or upon the occurrence of certain events. For example, the game play advice database 130 may only retain the top-100 ranked game play advice submissions. Once a particular instance of game play advice falls below a top-100 threshold, that particular instance may be deleted from the game play advice database 130 . Expiration may be temporal such that instances of game play advice that are not accessed for a particular period of time are removed from the game play advice database 130 . Instances of game play advice may also be removed from the game play advice database 130 a predetermined number of days after having been submitted to the system 100 . [0037] Ranking engine 140 is configured to manage the ranking of game play advice stored, in game play advice database 130 . When new game play advice is received, the ranking engine 140 of FIG. 1 will assign a default ranking to that new instance of game play advice. This default ranking and any other ranking (including those generated as a result of user feedback) may be measured utilizing any rubric capable of distinguishing one instance of user-generated game play advice from another. Rankings may be numeric (e.g., 1, 2, 3 . . . 101, 102, etc.) or characteristic (e.g., poor, good, very good, excellent, etc.). Simplistic rankings may also be used such as a binary indication of ‘good’/‘bad’ or ‘thumbs up’/‘thumbs down’. A percentage value may also be used by ranking engine 140 . For example, an ‘86% ranking’ may reflect that 86 percent of all user feedback received with respect to a particular instance of game play designated the advice as ‘good or better.’ [0038] Tie-breakers may be utilized by the ranking engine 140 with respect to multiple instances of game play advice that are allocated rankings of equal value. Equally-ranked game play advice may be distinguished by an alphabetical ordering of the screen name or real name of the user submitting the game play advice. Equally-ranked game play advice may also be displayed, based on the time the game play advice was submitted. Previously received and equally ranked game play advice may be moved to the bottom of a ranking ladder versus more recently received (and equally ranked) game play advice. Equally-ranked game play advice may also be displayed in a random order albeit in the context of other equally-ranked advice. [0039] Ranking engine 140 may operate in conjunction with ranking database 180 to maintain a record of a current or prior ranking of any particular instance of game play advice. Ranking engine 140 may also work in conjunction feedback engine 160 , feedback database 170 , and, in some embodiments, optional weighting engine 190 to more accurately identify the perceived quality of game play advice as adjudicated by a community of users. [0040] Game play advice display engine 150 is configured to display user-generated game play advice in accordance with a ranking result generated by ranking engine 140 . Game play advice display engine 150 acquires information from the game play advice database 130 (the advice) and the ranking database 180 (the ranking of the game play advice as determined by ranking engine 140 ) and displays the game play advice in accordance with an allocated ranking. The game play advice display engine 150 may utilize an asynchronous programming language to provide real-time (or substantially near real-time) updates to ranked game play advice for display to a community of users. [0041] Game play advice display engine 150 may utilize a ladder ranking of game play advice. In such an embodiment, the highest quality advice is presented at the top of a ladder and the worst advice is relegated to the bottom of the ladder. The quality of the advice decreases as a user moves from the top of the ladder to the bottom. In some embodiments, the particular arrangement of the advice may be subject to user or system preferences (e.g., the advice may be listed in an inverse order where the best advice is listed at the bottom of the ladder and the worst advice at the top). FIG. 5A illustrates an exemplary ladder ranking 500 of user-generated game play advice ( 510 a . . . f ). [0042] In FIG. 5A , the ladder 500 includes six exemplary instances of user-generated game play advice ( 510 a . . . f ). Each instance of game play advice identifies a title of the interactive game for which the advice is rendered 520 (i.e., SOCOM 3); the nature of the advice 530 (i.e., pertaining to ‘unlockable’ weapons); and the particular unlockable weapon at issue 540 (e.g., an IW-80 A2, an STG-77, a medium scope, and a front grip). Each instance also includes the advice itself 550 (e.g., “Complete the Poland Theater of Operations” in the case of instance 510 a ). [0043] The information displayed in each instance of game play advice (e.g., game title, nature of the advice, etc.) and the format of the same (e.g., text entries versus graphical illustrations) may vary depending on a particular embodiment of system 100 and game play advice display engine 150 . Additional information may also be displayed in each instance of game play advice. For example, an embodiment of ladder 500 may include the screen name of the user submitting particular information, the date the advice was submitted, a visible indication of the ranking of the instance of game play information (e.g., 1 of 6; 86% approval; thumbs up), or the number of times feedback has been rendered with respect to that particular instance of game play advice. An indication that a particular ranking is the result of a default ranking may also be displayed. [0044] In FIG. 5A , the best quality game play advice is displayed at (or near) the top of the ladder 500 . With respect to this particular game title, the IW-80 A2 may represent a particularly desirable weapon. Information regarding acquisition of this weapon may, therefore, be highly valued (i.e., to obtain this weapon “Complete the Poland Theater of Operations” as reflected by advice 550 of instance 510 a ). [0045] In another instance of game play advice ( 510 f ), the weapon is the same as that discussed in the most highly ranked instance ( 510 a ) (i.e., the aforementioned IW-80 A2) but the advice is of such poor quality that the advice is located at the lower-most rung of the ranking ladder 500 . With respect to game play advice instance 510 f, the user submitting the ‘advice’ has just begun playing this particular game title and does not know what an IW-80 A2 is or how to acquire the same. As such, this unhelpful instance of game play advice is appropriately ranked, and subsequently displayed at the bottom of the ranking ladder 500 . As a result of this ranking, a user searching for information concerning the acquisition of an IW-80 A2 saves time by avoiding review of unhelpful information. Further, the user searching for advice on acquiring the IW-80 A2 is more likely to receive complete and accurate advice. [0046] Game play advice display engine 150 may display advice in the context of a real-world virtual environment and/or a first- or third-person avatar. In such an embodiment, an avatar may move about a virtual environment like that offered by Sony Computer Entertainment Inc.'s “Home.” “Home” is a three-dimensional online user community service that may be accessed utilizing the PlayStation®3 entertainment system. [0047] The “Home” virtual environment offers a “Hall of Fame,” two examples of which are illustrated in FIG. 5B and FIG. 5C , and that could be used in conjunction with the display of user-generated game play advice. For example, display area 560 could be used to display a ladder ranking 500 like that discussed in the context of FIG. 5A . Virtual objects associated with a reward or particular achievement may also be displayed such as a trophy. Game play advice may be displayed in the context of particular game titles or users. [0048] In a virtual environment like that shown in FIG. 5B and FIG. 5C , game play advice display engine 150 may be integrated with the host of the virtual environment. Game play advice display engine 150 may also access the virtual environment through an application programming interface (API) native to the environment. [0049] Other means of display of game play advice beyond the aforementioned ladder and virtual environment are within the scope of the present invention. Game play advice may be listed as a series of entries in a ‘chat’ string. Game play advice may be displayed and detailed commentary (in addition to ranking feedback) concerning the quality of that advice may be provided by the community of users. Game play advice may also be provided through, a series of hyperlinks. Graphic images may also be utilized, especially in the context of game play advice that incorporates full motion video or still images. Links to audio files may be appropriate in the ease of audio-rendered advice. All of the aforementioned means of providing game play advice to a community of users (and in accordance with an assigned default or feedback controlled ranking) may be managed by the game play advice display engine 150 . [0050] Feedback engine 160 is configured to accept feedback from other game players following their viewing and subsequent use of game play advice provided via the game play advice display engine 150 . Feedback engine 160 may be integrated or work in conjunction with game play advice display engine 150 with respect to receiving feedback. For example, feedback engine 160 may generate a prompt for receiving user-generated feedback. The prompt may be displayed in the immediate context of particular instances of game play advice, which are displayed by game play advice display engine 150 . [0051] User feedback may be any subjective assessment capable of distinguishing one instance of user-generated game play advice from another. User feedback may be numeric (e.g., 1 to 10, with 10 being high quality and 1 being low) or characteristic (e.g., good, very good, excellent, etc.). Simplistic binary indications of ‘good’ or ‘bad’ or a ‘thumbs up’ or ‘thumbs down’ may also be used. Feedback may include a textual (or spoken) assessment of the user-generated game play advice. Feedback may be entered manually (e.g., entry of a ‘10’ through a virtual keyboard), selected from drop down menus, or submitted via graphic representations such as on-screen icons (e.g., selecting a ‘thumbs up’). [0052] Feedback engine 160 may also be configured to request and accept a grade for a particular user from a community of users, the user having submitting game play advice to the system 100 . The user grade may be a subjective assessment of a particular user registered with system 100 . Other users in a community may grade a particular user based on their knowledge of the graded user's in-game exploits in a manner similar to providing feedback with respect to game play advice. [0053] User grades may also be assessed automatically by the ranking engine 140 or an independent user grade engine (not shown). A grade for a particular user may be allocated with respect to the time that a user has been registered with the system 100 or played a particular game title (thus suggesting experience). Grades may also be assessed based on the number of tasks that a user has completed in a particular game or the number of levels that the user has ‘conquered.’ User grades may be particular to game, geographic region, or the entirety of the gaming network. The game community may also be defined by various tiers of experience (e.g., beginners, intermediate users, and experts). User grades may also be allocated within the delineation of a particular tier to which a graded user belongs. [0054] Feedback database 170 is configured to manage user feedback to game play advice submitted through feedback engine 160 . Feedback database 170 may be configured to store all community generated feedback as it pertains to game play advice. Certain feedback may expire over time (e.g., a predetermined number of days after having been submitted to the system 100 ). Feedback database 170 may track the nature of the feedback (e.g., a subjective assessment) with respect to a particular instance of game play advice. Feedback database 170 may further track the identity of the user submitting user feedback via the feedback engine 160 . [0055] Ranking database 180 is configured to manage ranking of user-generated game play advice as ranked by the feedback engine 140 . Ranking database 180 may also store user grade information generated by the ranking engine 140 . Ranking database 180 may be updated in real-time (or substantially in real-time) in order to provide game play advice display engine 150 with the most up-to-date and available ranking information as it pertains to particular instances of game play advice. Ranking information stored in the ranking information database 180 may expire after a set period of time. Lower ranked game play advice (e.g., advice falling below a certain minimum ranking) may be removed from the ranking database 180 while higher ranked information is maintained in the database 180 . [0056] Optional weighting engine 190 may be used for ranking user-generated game play advice based on the quality of the advice and the reputation or experience of the user submitting the advice. Optional weighting engine 190 is configured to introduce a weighting algorithm that allocates a particular value to the grade of a user submitting game play advice and another value to the actual game play advice. For example, if the user is regarded by the game community (i.e., the user has a higher user grade) but the game play advice submitted by the player is of low quality (as reflected by user feedback), the optional weighting engine 190 may apply a first weighting value to the user grade (e.g., 75%) and a second weighting value to the game play advice (e.g., 25%) to formulate (in conjunction with the ranking engine 140 ) a ranking of the game play advice. The game play advice is then displayed, through the game play advice display engine 150 whereby the first and second weighting values allocated by the optional weighting engine 190 proportionally affect the ranking of the game play advice. The actual weighting valuations applied to the user grade and the game play advice may be set and adjusted by an administrator of the system 100 . [0057] FIG. 2 illustrates an exemplary method 200 for ranking user-generated game play advice based on the quality of the advice. The steps identified in FIG. 2 (and the order thereof) are exemplary and may include various alternatives, equivalents, or derivations thereof including but not limited to the order of execution of the same. The steps of the process of FIG. 2 (and its various alternatives) may be embodied in hardware or software including a computer-readable storage medium (e.g., optical disc, memory card, or hard drive) including instructions executable by the processor of a computing device. [0058] In step 210 , user-generated game play advice is received from a user in the community via an interface generated by the game play advice submission engine 120 . Upon receipt of the user-generated game play advice in step 210 , the advice is processed by the system 100 as described in the context of FIG. 1 and assigned a default ranking by ranking engine 140 . The game play advice may be stored in game play advice database 130 . The default ranking may be stored in ranking database 180 . [0059] The processed and default ranked game play advice is subsequently displayed via the game play advice display engine 150 in step 220 . Upon display in step 220 , the user-generated game play advice is available for viewing by other members of the gaming community. The members of the community may then act upon that advice during the course of game play. [0060] The newly received and default ranked game play advice is also displayed in conjunction with previously received game play advice, which is also stored in game play advice database 130 . The previously received game play advice may have been previously displayed and ranked or may be displayed for the first time with a default ranking (i.e., multiple instances of game play advice are being displayed for the first time). The newly received game play advice may also be displayed with pre-packaged game play advice from the game publisher. [0061] A user acting upon any displayed game play advice may return to the ranking system 100 and provide feedback as to the quality of that particular game play advice in step 230 . The feedback may be provided via a prompt generated by feedback engine 160 . The nature of the feedback may be like that described in the context of FIG. 1 with respect to feedback engine 160 (e.g., a number of ‘stars’ or ‘thumbs up’ or ‘thumbs down’). Advice that resulted in better game play may receive a higher ranking than advice that resulted in lesser game play. The presentation of the game play advice may also affect the ranking. For example, if the advice was presented in such a way as to make the advice confusing notwithstanding the validity of the advice, the particular instance may receive a lesser ranking. [0062] After having received feedback in step 230 , the ranking engine 140 of system 100 will rank the new game play advice against previously received (and possibly ranked) game play advice in step 240 . Ranking of the new game play advice with respect to the previously received (and perhaps ranked) game play advice will take into account the feedback received by the feedback engine 160 and stored in feedback database 170 . After having received an initial indication of quality based on user feedback, game play advice will lose its ‘default’ ranking and move up or down a ladder of all available game play advice based on its valuation against other game play advice. [0063] Following the ranking operation of step 240 , the results of which may be stored in ranking database 180 , the new game play advice and previously received game play advice will be (redisplayed by the game play advice display engine 150 in step 250 . The (re)display of the game play advice will reflect any received user feedback from step 230 and the subsequent ranking operation of step 240 . Based on the ranking operation of step 240 , quality game play advice will rise to the top of a list of game play advice or be communicated to the community of users such that they know the advice that has received high approval from the community versus game play advice perceived to have little or no value. [0064] The method 200 of FIG. 2 may operate in real-time (or substantially in real-time) using an asynchronous programming language such as Ajax. In an asynchronous language like Ajax, small amounts of data are continually exchanged, with a database so that an entire user interface need not be reloaded, in response to each user interaction. In such an embodiment, an XMLHttpRequest object may be utilized to fetch the most recent game play advice rankings from the ranking database 180 of FIG. 1 . This ranking information, and the corresponding game play advice retrieved from game play advice database 130 , may then be displayed via an interface generated by the game play advice display engine 150 . Relationships between rankings, user feedback, and game play advice may be reflected by metadata or header data stored in the various databases of system 100 . Game play advice rankings may thus be updated as feedback is received and new rankings are calculated. [0065] The method 200 of FIG. 2 may also operate subject to a predetermined schedule. For example, the ranking engine 140 may update the ranking database 180 at five minute intervals (or any other time period as may be determined by a system administrator). Once the ranking database 180 is updated as a result of a regularly scheduled ranking operation, the newly updated ranking information may be pushed to the game play advice display engine 150 for display to the community of users in conjunction with the game play advice retrieved from game play advice database 130 . The updated ranking information in the ranking database 180 may also be available for access in response to a user request or query. A user request for ranking information may instantiate the ranking operation and the subsequent display of ranked game play advice. [0066] FIG. 3 illustrates an exemplary method 300 for ranking user-generated game play advice based on the reputation of the user submitting the advice. The steps identified in FIG. 3 (and the order thereof) are exemplary and may include various alternatives, equivalents, or derivations thereof including but not limited to the order of execution of the same. The steps of the process of FIG. 3 (and its various alternatives) may be embodied in hardware or software including a computer-readable storage medium (e,g., optical disc, memory card, or hard drive) including instructions executable by the processor of a computing device. [0067] In step 310 , user-generated game play advice is received at the system 100 from a user in a game community. Receipt of game play advice may occur through a user Interface generated by the game play advice submission engine 120 . The submitting user may be identified as part of the submission process. Identification may occur through manual entry of a screen name. Identification may also occur via a user profile accessed when the user logged into the gaming community. [0068] Automated grading of the submitting user by the ranking engine 140 takes place in step 320 such that a determination as to the authority of the provided game play advice may be made. For example, if a user is playing a particular game for the first time, any advice proffered by that player is likely of little value due to that player's general inexperience with the game. If a user is experienced with respect to that game, however, then any advice provided by that user may be of greater value due to their vast experience with game play. Experience may be derived from game play statistics or other data, which may be associated with a user profile. [0069] Alternatively, the submitting user may be graded based on their actual performance in a particular game. A particular user may play a game numerous times but lack any exceptional ability with respect to that particular game. In these instances, grading the user based on the number of times that they have played the game may be misleading. Grading the user based on performance in the game may be more indicative of the quality of the advice the user might offer. [0070] User performance may be based on any variety of factors. For example, a user may be graded based on a score achieved, a level reached, or a length of the user existed in a particular game environment without being ‘killed.’ Performance may also be based on objectives completed, items obtained, weapons mastered, enemies killed, and so forth. [0071] Once the user is graded in step 320 , the ranking engine 140 will rank new game play advice against previously received (and perhaps ranked) game play advice in step 330 . After having received an initial indication of quality based on grading of the user, game play advice will be ranked and that ranking information will be stored in ranking database 180 while the game play advice is stored in game play advice database 130 . [0072] Following the ranking operation of step 330 , the new game play advice and previously received game play advice will be displayed in step 340 by the game play advice display engine 150 . The display of the game play advice will reflect the grading of the user with respect to the game play advice as occurred in steps 320 and the subsequent ranking operation of step 330 . Based on the ranking operation of step 330 , quality game play advice will rise to the top of a list of game play advice or be communicated to the community of users such that they know the advice was offered by a game player of exceptional ability versus having come from a user with little to no experience or ability. [0073] The method 300 of FIG. 3 may operate in real-time or substantially in real-time. Like the method of FIG. 2 ( 200 ), such real-time functionality may be effectuated using an asynchronous programming language whereby the most recent game play advice rankings vis-à-vis a user grade are retrieved from the ranking database 180 and displayed via the game play advice display engine 150 . In this matter, game play advice rankings are updated as user grading is calculated. [0074] Like the method of FIG. 2 ( 200 ), the method of FIG. 3 ( 300 ) may also operate subject to a predetermined schedule whereby the ranking engine 140 updates the ranking database 180 at regular intervals. Once the ranking database 180 is updated as a result of a regularly scheduled ranking operation, the newly updated ranking information may be pushed to the game play advice display engine 150 for display to the community of users in conjunction with the game play advice retrieved from game play advice database 130 . Alternatively, the updated information in the ranking database 180 may available for access in response to a user request or query. A user request for ranking information may instantiate the ranking operation and the subsequent display of ranked game play advice. [0075] User grading may also be in response to feedback received from the gaming community. In such an embodiment, user grading step 320 will involve feedback engine 160 calculating a community valuation of a particular user based on information retrieved from the feedback database 170 and prior ranking information retrieved from the ranking database 180 . Steps 330 and 340 of the method 300 of FIG. 3 will proceed as described above with the exception that the ranking of game play advice is now based on user feedback rather than an automated determination made solely by ranking engine 140 . [0076] In a still further embodiment, the user grade may involve a weighting algorithm imposed by optional weighting engine 190 . In such an embodiment, community feedback may be assigned a first weighting value by the weighting algorithm of weighting engine 190 . The automated ranking generated by the ranking engine 140 may be allocated a second weighting value. These weighted values may proportionally affect a final ranking (also calculated by the ranking engine 140 ) that is ultimately stored in the ranking database 180 for retrieval by the game play advice display engine 150 . [0077] FIG. 4 illustrates an exemplary method 400 for ranking user-generated game play advice based on the quality of the advice and the reputation of the user submitting the advice. The steps identified in FIG. 4 (and the order thereof) are exemplary and may include various alternatives, equivalents, or derivations thereof including but not limited to the order of execution of the same. The steps of the process of FIG. 4 (and its various alternatives) may be embodied in hardware or software including a computer-readable storage medium (e.g., optical disc, memory card, or hard drive) including instructions executable by the processor of a computing device. [0078] In step 410 , user-generated game play advice is received at the system 100 from a user in a game community. Upon receipt of the user-generated game play advice in step 410 , the advice is processed by the system 100 and assigned a default ranking. Game play advice may be initially received through an interface generated by the game play submission engine 120 and stored in the game play advice database 130 . Allocation of a default ranking may be allocated by ranking engine 140 . [0079] The processed and default ranked game play advice is subsequently displayed by the game play advice display engine 150 in step 420 . The game play advice display engine 150 retrieves the default ranking information from ranking database 180 and the game play advice from the game play advice database 120 . Upon display in step 420 , the user-generated game play advice is available for viewing by other members of the gaming community who may then act upon that advice during the course of game play. [0080] The newly received and default ranked game play advice may also be displayed in conjunction with previously received game play advice. The previously received game play advice may have been previously displayed (and ranked) or may be displayed for the first time with a default ranking. Display may take place concurrent with pre-packaged game play advice from the game developer, which may also be ranked. [0081] In step 430 , the submitting user is graded. Grading of the submitting user takes place such that a determination as to the authority of the game play advice provided may be made as was the case in FIG. 3 . As was the case in FIG. 3 , a user may be graded based on experience playing a particular game or performance with respect to a particular game. Grading may also be based on community feedback. [0082] In step 440 , feedback as to the quality of particular game play advice may be provided by users in the community via feedback engine 160 . Advice that results in better game play may receive better feedback than advice that resulted in lesser game play or that was perhaps presented in such as way as to make the advice confusing and otherwise ineffective. Feedback may be stored in feedback database 170 . [0083] In step 450 , the grading of the user as occurred in step 430 and the feedback provided with respect to particular game play advice as occurred in step 440 may be weighted. Weighting of the user grade and advice feedback may occur through optional weighting engine 190 . As noted in the context of FIG. 1 , the ratio of importance of the user grade versus the user feedback may be allocated as to best overall evaluate the advice provided by the user. [0084] Following weighting of the user grade and the user feedback in step 450 , the ranking engine 140 will rank the new game play advice against previously received game play advice in step 460 . After having received an initial indication of quality based on user feedback and the user grade, game play advice will lose its ‘default’ ranking and move up or down a ladder of ail available game play advice based on its valuation against other advice as a whole. [0085] Following the ranking operation of step 460 , the new game play advice and previously received game play advice will be (redisplayed in step 470 by game play advice display engine 150 . The (re)display of the game play advice will reflect the results of the ranking operation of step 460 , which may be retrieved from ranking database 180 in conjunction with the actual game play advice from game play advice database 130 . Based on the ranking operation of step 460 , qualify game play advice from knowledgeable game players will rise to the top of a list of game play advice or be communicated to the community of users such that they know the advice that has received a combination of high approval from the community and was offered by an otherwise experienced or well qualified game player. [0086] While the present invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the true spirit and scope of the present invention. For example, the aforementioned system 100 and methods discussed therein (e.g., FIG. 2-4 ) may be utilized to receive submissions, rank, display, accept feedback, and (re)rank and (re)display various forms of information other than game play advice. For example, the present system and methods may be employed in the context of search engine results or queries for on-line audio and video content. The aforementioned system and methods may also be used with respect to (reverse) auctions and bidding based on valuation/feedback of a seller, vendor, and/or product. [0087] In addition, modifications may be made without departing from the essential teachings of the present invention. Various alternative systems may be utilized to implement the various methodologies described herein and various methods may be used to achieve certain results from the aforementioned systems.

1a

FIELD OF THE INVENTION The invention relates to UV-barrier formulations which result in products which effectively resist the transmission of ultraviolet light therethrough. The invention also relates to UV-barrier formulations which result in products with improved resistance to ultraviolet light. In particular, the invention relates to UV barrier formulations for polyester resins that have improved resistance to ultraviolet radiation, and significantly reduce ultraviolet light transmission in the resulting resin products. BACKGROUND OF THE INVENTION Sunlight and conventional indoor lighting comprises energy in the visible range and in the ultraviolet (UV) range. The ultraviolet component, especially radiation ranging from 200 nm to 400 nm, is primarily responsible for the degradation of organic matter, including polymeric products and food products. Such food products are typically contained in packaging composed of one or more polymeric components. Thus, it is desirable that the polymeric packaging materials minimize, as much as possible, the transmission of ultraviolet light. Polyester resins are widely used in packaging materials due to their excellent clarity and transparency. Polyesters are subject to degradation by ultraviolet light and will transmit UV light. Ultraviolet absorbers are added to polyester formulations to increase the resistance of the final resin product to UV degradation, and to decrease the transmission of ultraviolet light through the final product but maintain the transmission of visible light. As the use of polyester packaging, and in particular, PET (polyethylene terephthalate), continues to grow, more and more foods and drinks are now being packaged in polyester-based resins. As mentioned above, some of the ingredients in food and drink items are susceptible to degradation by UV light from the sun and from grocery/convenience store lighting. Such degradation can result in changes in color, flavor or nutritional value of the contents of the packaging. Polyethylene terephthalate with no UV absorber will protect against UV light by providing around 10% transmission at about 320 nm wavelength. In the last few years, chemical additive suppliers and PET producers have begun selling products that block UV light, and reduce the harmful exposure that degrades PET containers, and the contents within these containers. These additives can be incorporated at an injection molding step. PET producers are also incorporating these same commercial additives or proprietary formulations directly into their processes. This invention relates to formulations that provide end products that significantly reduce UV transmission therethrough, and more reliably withstand the effect of UV radiation without significant degradation or deterioration. These formulations or compositions also offer an alternative supply option to those that wish to convert to the use of PET containers from other conventionally UV resistant polymer based containers. SUMMARY OF THE INVENTION It is an object of the invention to provide UV-barrier formulations for polyester resins, which results in products which effectively resist the transmission therethrough of ultraviolet light. It is another object of the invention to provide UV-barrier formulations for polyester resins, which result in products with improved resistance to ultraviolet light. It is another object of the invention to provide polyester formulations which result in products which effectively resist the transmission therethrough of ultraviolet light. It is another object of the invention to provide polyester formulations which result in products with improved resistance to ultraviolet light. It is another object of the invention to provide a process for the manufacture of UV-barrier formulations which result in products with improved resistance to ultraviolet light. It is another object of the invention to provide a process for the manufacture of UV-barrier formulations which result in products which effectively resist the transmission therethrough of ultraviolet light. It is another object of the invention to provide a process for the manufacture of polyester resins which result in products with improved resistance to ultraviolet light. It is another object of the invention to provide a process for the manufacture of polyester resins which result in products which effectively resist the transmission therethrough of ultraviolet light. It is a further object of the present invention to provide a process which will homogeneously mix the polyester material and the UV-barrier formulation so that they will reliably stay together uniformly during the mixing process and thereafter. It is a further object of the present invention to provide polyester products which effectively resist the transmission therethrough of ultraviolet light. It is a further object of the present invention to provide polyester products which exhibit an exceptional resistance to UV radiation. These and other objects of the present invention have been satisfied, either individually or in combinations thereof, by the discovery of a UV-barrier formulation comprising the following components: polyethylene naphthalate (PEN) and a polyoxyalkylene UV absorber (such as CLEARSHIELD UV absorber from Milliken Chemical), by the discovery of a polyester formulation comprising one or more polyesters, polyethylene naphthalate and the polyoxyalkylene UV absorber, and by the products produced by these formulations and the manufacturing processes thereof. BRIEF DESCRIPTION OF THE DRAWING Various other objects, features and attendant advantages of the present invention will be more fully appreciated, as the same become better understood from the following detailed description, when considered in connection with the accompanying drawing. FIG. 1 is a transmission profile comparing a preferred formulation of the invention with other conventional formulations. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention relates to UV-barrier formulations comprising polyethylene naphthalate (PEN) and a polyoxyalkylene UV absorber, and polyester formulations comprising one or more polyesters, polyethylene naphthalate and a polyoxyalkylene UV absorber (or CLEARSHIELD). These formulations blend a polyoxyalkylene based UV absorber with a PEN component to reduce UV transmission to around 10% at UV wavelengths up to about 390 nm. The advantages of these formulations are both economical and functional. The PEN is the less costly additive, but it only provides UV protection up to about 360 nm, with little UV absorbance effect at higher wavelengths. CLEARSHIELD (a preferred polyoxyalkylene UV absorber), a more costly additive, can provide protection from about 360 nm to about 390 nm. The use of PEN to provide UV protection at lower wavelengths provides a significant cost saving versus using only CLEARSHIELD, by permitting the use of less CLEARSHIELD than normally needed in order to obtain the same level of UV absorbance for the overall composition. The use of both of these additives together, provides a very economical formulation with an unexpected improvement in UV resistance, above what would be expected based on the combination of these additives. In particular, one improvement seen is an increase in the level of UV absorbance up to about 390 nm when the PEN and polyoxyalkylene UV absorber are combined, even though only one of the components actually has a significant measurable absorbance at 390 nm. Thus, while one might expect some absorbance at 390 nm due to the polyoxyalkylene UV absorber component, the level of absorbance would be expected to be significantly lower, as the PEN does not normally absorb at that wavelength. The present inventors have found, however, that by combining the two UV absorbing components, there is a significant increase in absorbance at about 390 nm (i.e. significant reduction in UV transmission at about 390 nm) that would not be present using either component alone. While the present inventors do not wish to be bound by any particular theory on the mechanism of action for the present invention, it appears that there is either an interaction or an actual chemical reaction, for example, the formation of a chemical bond, between the PEN and polyoxyalkylene UV absorber components (and possibly an interaction or chemical reaction with either or both of these components and the polyester matrix) that causes the UV absorbance at wavelengths up to about 390 nm to significantly increase at a given level of the UV absorber. The formulations of the invention may be prepared in the melt state using conventional techniques known in the art, including melt extrusions from batch, semi-continuous or continuous. It is preferable to add the polyoxyalkylene UV absorber as late as possible in the melt process due to its potential sensitivity to discoloration. In one embodiment of the invention, a composition comprising a polyester matrix is prepared having an amount of UV absorbing composition sufficient to provide a UV transmission of about 20% or less at about 390 nm, and where the UV absorbing composition comprises polyethylene naphthalate (PEN) and the polyoxyalkylene UV absorber. In another embodiment, the above composition provides a UV transmission of about 15% or less, more preferably 10% or less, and even more preferably 5% or less, at about 390 nm. In another preferred embodiment of the invention about 1000 ppm (0.1 wt %) CLEARSHIELD and about 0.2 wt % PEN are mixed with a polyester matrix comprises predominantly PET. The amounts of these components are based on the total weight of the polyester formulation or composition. This combination provides UV protection in the PET product, and also provides an economical UV barrier with good appearance in the final product. It has been determined that adding more than 0.2% PEN will not further improve the UV barrier of PET, but adding less than 0.1% will reduce the UV barrier. The equivalent UV barrier of about 10% transmission at about 390 nm, using both PEN and CLEARSHIELD, could be provided by using 2000 ppm CLEARSHIELD without PEN. However, this formulation would considerably increase the cost of providing the same UV barrier protection as the PEN/CLEARSHIELD combination. In another embodiment of the invention, the additives are incorporated into a polyester resin, such as PET resin, by injection into the molten polyester in the transfer line, downstream of the last polymerization vessel and upstream of the pelletizers. This injection can occur using a twin screw extruder to melt the PEN polymer and combine it with the polyoxyalkylene UV absorber, for example, liquid CLEARSHIELD 390B or 390R. The molten mixture is then injected into the transfer line using a metering pump. After the PEN/CLEARSHIELD formulation is injected into the polyester melt stream, it is mixed using both dispersive and distributive mixing to ensure a good mix with the PET melt stream. The mixture is then pelletized. The pellets may be solid state polymerized to further raise the intrinsic viscosity (IV) of the resulting resin. This may involve holding the pellets at temperatures above about 200° C. for greater than about 12 hours. The pellets should not degrade or significantly change color during the solid stating process. In another embodiment, a concentrated masterbatch of PEN and the polyoxyalkylene UV absorber is produced and then dry blended with a polyester resin. The UV absorber of the present invention is a polymeric UV absorber having various chain lengths of polyoxyalkylenes, as described in U.S. Pat. No. 6,602,447, the contents of which are hereby incorporated by reference. Within the context of the present invention, the UV absorber as described in U.S. Pat. No. 6,602,447 is denoted herein as a “polyoxyalkylene UV absorber”, although it may contain other types of groups in the backbone of the polymeric compound, with oxyalkylene groups being present with at least 6 total moles of oxyalkylene units per molecule of UV absorber, as in the above noted '447 patent. An embodiment of the polyoxyalkylene UV absorber of the present invention is that described in the '447 patent, which is an ultraviolet compound conforming to the structure represented by Formula (I) wherein R 1 , R 2 , R 3 , R 4 , and R 5 are the same or different and are selected from the group consisting of C 1-20 alkyl, halo, hydroxyl, hydrogen, cyano, sulfonyl, sulfo, sulfato, aryl, nitro, carboxyl, C 1-20 alkoxy, and B-A, wherein at least one of R 1 , R 2 , R 3 , R 4 and R 5 is B-A wherein B is selected from the group consisting of N, O, S, SO 2 , SO 3 , CO 2 , and A is represented by the Formula (II) [polyoxyalkylene constituent] 2 R′  (II) wherein ‘polyoxyalkylene constituent’ is selected from the group consisting of at least three monomers of at least one C 2-20 alkyleneoxy group, glydicol, glycidyl, or mixtures thereof, R′ is selected from the group consisting of hydrogen, C 1-20 alkoxy, C 1-20 alkyl, and C 1-20 esters; wherein if B is N, then Z is 2, and if B is other than N, then Z is 1; X and Y are the same or different and are selected from the group consisting of hydrogen, cyano, C(O)OR, C(O)R, C(O)NR″R′″, C 1-20 alkyl, and C 1-20 alkoxy, or X and Y are combined to form a ring system, and R, R″, and R′″ are defined as above for any of R 1 , R 2 , R 3 , R 4 , and R 5 ; and wherein if X and Y are not combined to form a ring system then at least one of said X and Y is either cyano or hydrogen. A preferred embodiment of the UV absorber is a commercially available product trade-named CLEARSHIELD (available from Milliken), most preferably CLEARSHIELD 390B or 390R. The polyesters of the invention may include, but are not limited to, polyester synthesized from aliphatic, aromatic or cyclic (aliphatic or aromatic) dicarboxylic acids, or an aliphatic, aromatic or cyclic (aliphatic or aromatic) ester, with an aromatic, aliphatic or cyclic (aliphatic or aromatic) diol; or an esters prepared from two or more aliphatic, aromatic or cyclic (aliphatic or aromatic) esters. Examples of polyesters include, but are not limited to, polyethylene terephthalate, polyethylene naphthalate, polyethylene isophthalate, polypropylene terephthalate, polybutylene terephthalate, poly(1,4-cyclohexylene dimethylene terephthalate) and polyethylene-2,6-naphthalene dicarboxylate, and mixtures thereof. Copolymers, blends and mixtures thereof are also included. Preferred embodiments of the present invention use polyethylene terephthalate polymers having copolymerized therewith from 0 to 5 wt % of isophthalic acid (or the dialkyl isophthalate counterpart, depending on whether the polyester is produced from a terephthalic acid or dimethyl (or dialkyl) terephthalate based process) and from 1 to 3 wt % of diethylene glycol. Such copolymers are commonly used as resins for the formation of various bottles and other containers, most commonly in the production of soda bottles. The term “polyesters,” “polyester matrix” or “polyester resins,” as used herein, refers to all of the above, and includes polyesters prepared from one or more monomers, and blends of one or more of such polyesters. The term “polymer or polymers,” “polymeric” or “resin or resins,” as used herein, refers to both homopolymers and copolymers prepared from one or more monomeric constituents, and to crosslinked systems thereof and branched systems thereof, including, but not limited to, grafted systems thereof. Dicarboxylic acids include, but are not limited to, aromatic dicarboxylic acids, such as terephthalic acid, isophthalic acid, phthalic acid and 2,6-naphthalenedicarboxylic acid; aliphatic dicarboxylic acids, such as adipic acid, azelaic acid, sebacic acid and decanedicarboxylic acid; and alicyclic dicarboxylic acids, such as cyclohexanedicarboxylic acid. Diols include, but are not limited to, aliphatic diols such as 1,4-butanediol, 1,3-propanediol, 1,6-hexanediol, monoethylene glycol, diethylene glycol, triethylene glycol and polyethylene glycol; alicyclic diols, such as 1,4-cyclohexanedimethanol; and aromatic diols such as bisphenol A. These diacids and diols may be used alone or in combination of two or more. Other polyester components include, but are not limited to, phthalic anhydride, trimellitic acid, pyromellitic acid, dimeric acid and 5-sodiumsulfoisophthalic acid. The polyesters can be produced by condensation reactions and/or ester exchange reactions, and other methods known in the art. Products of the invention include, but are not limited to, bottles, various-shaped containers, sheets, films, fibers, tubes, and the like. Products also include packaging materials, such as containers, sheets, blister packages, and the like, which can be utilized for storage purposes. Products of the invention may include one or more polyesters, optionally in combination with one or more different thermoplastics, in any combination. Other additives may optionally be added to the formulations of the invention to effectuate a desirable physical state. These additives include, but are not limited to solvents, viscosity modifiers, fillers, colorants, acid scavengers, antistatic agents and other UV absorbers. Additives may be added prior to, during, and/or after introduction of the UV-barrier formulation within the desired polyester matrix. EXAMPLES Having generally described this invention, a further understanding can be obtained by reference to certain specific examples, which are provided herein for purposes of illustration only, and are not intended to be limiting, unless otherwise specified. Example 1 Twenty pounds of a PEN/PET copolymer containing 90 wt % polyethylene terephthalate and 10 wt % polyethylene naphthalate were compounded with one pound of CLEARSHIELD 390B (available from Milliken) in a twin screw extruder. The compounded mixture was pelletized into a masterbatch. The masterbatch was dry blended with virgin PET polymer pellets at a 46.6 to 1 letdown ratio and the dry blend was used to injection mold preforms. The preforms were then stretch blow molded. The final concentration of PEN in the bottles was 0.200%. The final concentration of CLEARSHIELD 390B in the bottles was 0.100%. Transmission testing of the sidewall of the bottles produced demonstrated that at the concentration used this formulation provided UV protection up to 10% transmission at 390 nm. FIG. 1 is a transmission profile comparing a preferred formulation of the invention with other conventional formulations. The corresponding data for this FIGURE is listed in Table 1. TABLE 1 Transmission % at stated wavelength (invention) PET/0.2% PEN/0.1% Wavelength (nm) CLEARSHIELD PET PET/PEN 300 0 0.3 0.3 305 0 0.3 0.3 310 0 0.3 0.2 315 0 0.3 0.2 320 0 1.1 0.2 325 0 12 8 330 0 24.6 9 335 0 33 7 340 0 37.7 6 345 0 43 8.5 350 0 48.6 7 355 0.1 53.6 5 360 0.3 57.6 10 365 1 60.5 40 370 2 62.3 60 375 2.9 63.4 68 380 3.75 65.4 70 385 5 66.9 70.5 390 8 68.1 70.9 395 15 69.5 71.1 400 25 70.7 71.4 405 37 72 71.9 410 50 72.8 72.4 415 60 73.5 72.8 420 67 74 73.5 425 70 74.6 73.8 430 71.5 75.1 74.6 435 73 75.7 74.9 440 73 76.3 75.2 445 73.5 77.1 75.4 450 73.5 77.6 75.5 455 74 78 75.5 460 74 78 75.5 465 74.5 78 75.5 470 74.5 78 75.9 475 75 78.3 76.1 480 75 78.3 76.1 485 75 78.3 76.1 490 75 78.3 76.1 495 75 78.7 76.4 500 75.5 78.7 76.4 Obviously, additional modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood, that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit of U.S. nonprovisional patent application Ser. No. 10/043,071, by Marc M. Groz, entitled “Method and System for increasing expected return and maximum payout in a game of one or more players”, filed on Jan. 8, 2002, which is incorporated herein by reference. [0002] This application claims benefit of U.S. nonprovisional patent application 10/733,482 by Marc M. Groz, entitled “Programmable Financial Instruments”, filed on Dec. 11, 2003, which is incorporated herein by reference. [0003] This application claims benefit of U.S. Provisional Patent Application 60/643,292 by Marc M. Groz, entitled “Residual Value Lotteries”, filed on Jan. 13, 2005, which is incorporated herein by reference. BACKGROUND OF THE INVENTION [0004] U.S. patent application Ser. No. 10/043,071, filed Jan. 8, 2002 discloses a method and system for creating financial instruments whose future cash flows are at least partially determined by an event or events associated with playing of one or more games or in relationship to an event or events that can be modeled in game-theoretic terms. [0005] For example, a bond could have weekly interest payments that are linked to whether or not a particular state lottery has a grand-prize winner that week. If there is a winner, bondholders forgo one or more interest payments according to a predefined schedule. When there is no winner, bondholders collect interest payments large enough to compensate for the risk of periodic missed payments. [0006] An alternative mechanism would be to eliminate the bond entirely and to create a derivatives contract (funded or unfunded) with a bi-directional cash flow structure. In this instance, an investor or investors would receive periodic payments from a counterparty in exchange for guaranteeing a prize payment. In a preferred embodiment, the investor(s) would receive many small payments in exchange for making an occasional large payment. They would provide game operators (e.g. casino or state lottery) the ability to offer much larger prizes by accepting regular premia from the game operators. [0007] U.S. patent application Ser. No. 10/733,482, filed on Dec. 11, 2003, discloses methods and systems for creating and managing programmable financial instruments. [0008] A Residual Value (“RV”) lottery is a new kind of lottery What distinguishes RV lotteries from existing lottery games? In an RV lottery, a portion of the ticket price is set aside for saving or investment purposes, with the result that players build a nest egg for retirement, education, or other purposes through the very act of playing lottery games. By making residual values an essential part of the game, the act of buying a lottery ticket is transformed from participation in a game in which the average player loses money into participation in a game in which by design the average player makes money even when he doesn't win any of the prizes! BRIEF SUMMARY OF THE INVENTION [0009] I will begin by reviewing how RV lotteries work, illustrating with a specific example. Then I will discuss several alternative ways to implement RV lotteries with minimal overhead and at minimal cost. [0010] RVs can be applied to many kinds of games, not just lotteries (for details, see U.S. patent application Ser. No. 10/043,071). From a lottery's perspective, the goal is to bring in much larger revenues. This is accomplished by making the game more attractive to players so that existing players play more and new players-people who would seldom if ever buy a lottery ticket-are encouraged to play. What makes a game attractive to players? Existing games attract players through the promise of great prizes and the encouragement of many small prizes that-aside from their intrinsic value-foster the feeling that a big win is possible. RV lotteries add a new reason for playing, while keeping the old enducements. In an RV lottery, even the players who don't win anything are building a nest egg, one that preferably is held for them for a minimum number of years so that they—or their heirs—are guaranteed a tidy sum after (for example) a waiting period of ten or twenty years. [0000] RV lotteries offers the following innovations: [0000] First, it dramatically improves a lottery players “expected return” that's how much the average person would expect to get out of his or her purchase of a lottery ticket. Second, it provides lottery operators a means of guaranteeing to return to lottery players their full ticket cost, after a suitable holding period. Third, it offers downside protection to habitual players who are not also savers or investors, by building into the lottery a savings or investment vehicle built right into the game. Finally, RV lotteries provide lottery operators powerful tools for the creation of much larger prize pools to generate significantly greater revenues. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0015] Let me illustrate by comparing an ordinary lottery to an RV lottery in terms of how each allocates money from ticket sales, and how that money is distributed over time. [0016] To keep the math simple, from among the millions of lottery players, let's pretend that we can find 10,000 players who are all the same age—22 years old—and that they all start playing the lottery on the same day, bet the same amount ($5 per week) for the same period of time (45 years). The total spent on lotteries over the course of each person's playing life would be $11,700, which, multiplied by 10,000 identical players, yields total group purchases of $117,000,000. [0017] In a traditional lottery, the $117,000,000 would be divided between prize pool, money for education or other social good, and administrative costs. Let's say $50 million goes into the pool, $55 million goes for education, and $12,000,000 covers costs. The $50 million prize pool is itself comprised of $30 million in grand prizes and $20 million in small prizes. Again, for simplicity's sake, let's assume that the grand prizes are all $3 million, and the small prizes are all $200. [0018] Given these assumptions, we can figure out what happens to the 10,000 players. 10 of them hit the jackpot (unless some super-lucky guy wins more than once). The other 9,990 people lose on average $11,500 each (depending upon the number of $200 prizes they win), over the course of 45 years. [0019] Now consider the same group playing an RV lottery in which the residual value is set to 30%. This means that 30 cents out of every dollar in ticket sales is set aside into a special account for the benefit of the player and never put at risk in the game. Let's assume that this money is placed into a long-term investment account with an average rate of return of 10% per year. The remaining 70 cents is divided as usual amongst the prize pool, money raised for education or other socially useful purpose, and administrative costs. [0020] Of the $117 million, about $35 million would go into the special residual value accounts of the players, leaving a prize pool of $30 million ($18 million in grand prizes and $12 million in small prizes), $40 million for education, and $12 million for administrative costs. [0021] Now let's look at the impact of this RV lottery on the financial outcomes of the group of players. Ten of the 10,000 would win somewhat smaller $1.8 million dollar grand prizes (unless the odds were adjusted so that, for example, 6 players win $3 million grand prizes). But the major impact is on the 9,990 players, who instead of losing an average of $11,500 each, have residual value accounts worth about $70,000 each! The $35 million residual value accounts would be expected to grow to close to $700,000,000 at the end of 45 years! [0022] Two questions arise at this point. First, isn't the lottery losing money in this example (raising only $40 million instead of $55 million)? Also, if prizes are smaller or scarcer, will players still play as much? These are natural concerns. [0023] I have three answers to these questions: [0024] First, it stands to reason that a lottery with no losers would sell a lot more tickets. I believe that ticket sales could double or even triple as players begin to realize that they're saving or investing every time they play. This would translate to greater revenues and bigger prizes pools than existing lotteries. [0025] Second, Scores™, a patent-pending financial instrument (see U.S. patent application Ser. No. 10/043,071) could be sold to investors who would guarantee a larger prize pool in exchange for a reasonable return. Institutional investors (such as corporations and financial institutions) would have an incentive to purchase Scores for their unique ability to diversify portfolios. Super grand prizes backed by Scores would allow Lotteries to sell many more tickets. Imagine how many tickets might be sold if the potential prize were extremely large-a billion dollar jackpot could be offered. [0026] Finally, even without Scores, it is possible to customize an RV lottery to generate greater revenues and bigger prize pools, even assuming no increase in ticket sales! The key to doing this is altering the payout from the residual value account. Instead of mandating that 100% of the RV goes to the players, expand the purpose of the residual value accounts so that only a portion is kept by the players, while a second portion is transferred to the prize pool, and a third portion is transferred to the educational or other beneficiaries of the lottery. [0027] Transfers could be done according to a schedule, or they could be conditional on factors such as realized return of the residual accounts, number of tickets sold, or the size of the prize pool. Residual values could also be held in special accounts for use in future prize pools and/or for future social needs. This would make it possible to use the funds in these accounts as collateral, instead of simply transferring them to the prize pool or beneficiary. [0028] Let's call this type of lottery a Multiple Residual Value Lottery (“MRVL”). MRVLs relax the restriction that residual values are owned by (or held in trust for) the players (or their heirs or assignees): A MRVL countenances multiple uses of residual value accounts, including standard RV accounts, prize pool augmentation accounts, education (or other social purpose) accounts, and special purpose accounts which may be created by the lottery operator. [0029] Continuing with the example, the $15 million dollar shortfall for the state over 45 years could be partially or completely offset by allocating to the state a portion of the $700 million expected value at the end of 45 years. [0030] Implementation of multiple residual value accounts to allow for other uses is not limited to lottery games, but may be applied to any game in which a financial consideration is involved. [0031] Slot machine and other casino-type games may employ Residual Value accounts to enhance the expected return of one or more players. Said games may employ Multiple Residual Value accounts that include standard RV accounts, prize pool augmentation accounts, education (or other social purpose) accounts, and special purpose accounts which may be created by the game operator. [0032] Online and offline games and/or contests in which a financial consideration is involved may employ Residual Value accounts to enhance the expected return of one or more players. Said games may employ Multiple Residual Value accounts that include standard RV accounts, prize pool augmentation accounts, education (or other social purpose) accounts, and special purpose accounts which may be created by the game operator. [0033] Recreational and/or educational activities (including sports, exercise, and other forms of physical education) in which a financial consideration is involved for one or more participants in said activities, may employ Residual Value accounts to enhance the expected return of said one or more participants. Said activities (which from the standpoint of game theory, are considered games of one or more players), may employ Multiple Residual Value accounts that include standard RV accounts, prize pool augmentation accounts, education (or other social purpose) accounts, and special purpose accounts which may be created by the organizer of said activities. [0034] For example, exercise equipment (such as stationary bicycles, treadmills, etc.) that tracks individual performance may be electronically linked to one or more secure electronic databases that enable one or more system operators to track the performance of one or more participants. Residual Value accounts may be employed to enhance the expected return of said one or more participants. Said activities (which from the standpoint of game theory, are considered games of one or more players), may employ Multiple Residual Value accounts that include standard RV accounts, prize pool augmentation accounts, education (or other social purpose) accounts, and special purpose accounts which may be created by the organizer of said activities. In a preferred embodiment, a bicycle equipment manufacturer or distributor may conduct a Billion Dollar Bike Race™ by operating a Residual Value Game (as defined below) that would preferably be used to fund investment accounts owned by or held in trust for participants and offer a large prize based on one or more factors including chance, level of performance on the equipment as gauged by the data gathering devices of the game operator, or other factors. In an alternative preferred embodiment, operators of online multiplayer games would, by offering a Massive Multiplayer Residual Value Game, be able to fund investment accounts owned by or held in trust for participants and offer a large prize based on one or more factors including chance, level of performance at the game as gauged by the data gathering devices of the game operator, or other factors. [0035] I shall refer to the aforementioned games and/or activities as Residual Value Games (RVGs). Where Multiple Residual Value Accounts are employed, said games and/or activities shall be referred to as Multiple Residual Value Games (MRVGs). [0036] Having reviewed the features and benefits of RV lotteries, I now would like to consider some possible means of implementation that do not add undue burdens to lottery ticket retailers or to the operators of the lottery itself. For the sake of concreteness, I will limit my discussion to instant games, though many of the same solutions are easily adaptable to the online game segment. [0037] Consider the simplicity of an instant game ticket. Paid for by cash, it is a bearer instrument that has a definite value that the holder can ascertain for herself by making a few scratches with a coin. How can we preserve the simplicity of this transaction, if we need to keep track of a series of such transactions over a long period of time? [0038] Actually, there are many different ways to do this, none of them perfect, but most of them easily adapted with only minor modifications to the existing lottery infrastructure. Following are seven ideas for making RV lottery administration simple, three of which could be done today. The last four probably are a couple of years away from practical use. [0039] First, let's consider something as simple as a barcode printed on a membership card or mini keychain card. This is just like the kind all the supermarkets hand out to track purchases, using selected discounts as an incentive. The software for recording lottery ticket purchases would be essentially the same as already existing software that tracks grocery items. Players would need to register their membership ID in order to be eligible to receive the deferred payout of residual values accumulating in their accounts. Accounts would best be administered by a financial institution, such as a bank, brokerage, or mutual fund complex. [0040] Second, debit cards. Financial institutions that already issue debit cards might prefer to use them instead of a special purchase membership card with a bar code. The advantage would be that the payment processing and database infrastructure already exists. Of course, the same is true for credit cards, though the expense of credit card processing probably precludes their use for now. [0041] Third, stored value cards. Stored value cards, like cellular phone cards, fall somewhere in between barcodes and debit cards. Selling a rechargeable stored value card, used to purchase lottery tickets, would simplify the administration problem by greatly reducing the number of transactions for which residual value processing is required. Instead of taking 25 cents out of each and every ticket sold, the lottery administrator could take $5 out of a $20 stored value card, which would in effect prepay the residual value portion of a combination of $1, $2, and $5 games that would be played within a prescribed time period, for example, one year. [0042] Now I will mention the four ideas that, while not in my estimation currently feasible, could become so within the next couple of years. The first of these takes the stored value/debit card ideas a step further. Lotteries could use smart cards, which are like ordinary debit, credit, or stored value cards with the addition of some built in computer processing capability. While smart cards have not been widely adopted in the United States, they are in widespread use in Europe and elsewhere. If they catch on here, such cards could do more than record a transaction. They could be used to store all of the information currently residing on a ticket, making it possible for lottery operators to offer paperless lottery tickets. [0043] The second of these ideas begins by recognizing that it is entirely possible that smart cards will never catch on in the U.S. As more and more capabilities are being packed into cell phones, one idea that is literally “gaining currency” is the use of cell phones as wallets. If cell phones become wallets, they can be used to pay for and keep track of lottery tickets. Better yet, they can function as lottery tickets, storing all the information currently stored on a printed card (including images) and also keeping track of past purchases, residual values contributed, current account value, redemption dates, and other things. Incidentally, by making a cell phone into a combination lottery ticket/lottery terminal, new ways of playing including video and multi-player games would become possible. [0044] Beyond smart cards and cell phones, the increasing use of biometric sensors like retinal, fingerprint, and handprint scanners to identify and to authenticate people and transactions could be applied to lottery ticket sales. This would be especially useful to RV lotteries that need to keep track of ticket purchases over a prolonged period of time. Payment could still be in cash, with the biometric only used for identification. Or biometrics could be used for both identification and payment authorization, (for example) from Paypal™ or a checking account. [0045] Combining RV lotteries and Scores in one game would enable a lottery to offer a remarkable double incentive: RV lotteries to bring in non-traditional lottery players by enhancing the average player's financial outcome (and perhaps to guarantee his principal), Scores to sell more tickets to existing players by creating much larger super grand prizes. Example of a Guaranteed “No Loss” Lottery. An RV lottery could set aside 50% of each lottery ticket. This is the residual value. The remaining 50% would be allocated as usual amongst the prize pool, state revenues, and overhead. The 50% residual value would be used to purchase a 10 year zero coupon state bond (or fractional interests in a state bond). These would belong to (or be held in trust for) the player. Assuming that you had an effective interest rate of 7.2%, such lottery players would get their ticket's face value back when the bonds mature. The average holding period could be shortened by dynamic hedging, a risk management technique used by banks that would act as guarantors of the principal. A similar technique could be used to lower the required residual value. [0047] While the invention has been described in conjunction with specific embodiments, it is evident that numerous alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description.

1a

FIELD OF THE INVENTION The present invention relates generally to electron sources and specifically to electron sources for food treating apparatus and method for treating food. BACKGROUND OF THE INVENTION U.S. Pat. No. 5,356,646 to Simic-Glavaski (hereinafter Simic-Glavaski), which is hereby incorporated by reference in its entirety, discloses that the ingestion of externally generated oxidative products such as food cooked by a thermal process may be carcinogenic. When food is cooked by a thermal process it may tend to have a carcinogenic effect due to the depletion of electrons in the food. It is believed that the food is depleted of electrons during a cooking process due to thermal excitation and oxidation. Simic-Glavaski discloses by adding electrons to food that is in a cooking vessel or in contact with a grill carcinogenic effect can be reduced. Simic-Glavaski discloses a cooking apparatus and a method of supplying electrons to food that is contained in the vessel or that is in contact with the grill. In an embodiment disclosed by Simic-Glavaski, respective electrodes are placed in a cooking medium, such as oil, water or the like, and electric potential and electric current are provided thereby to food. It would be desirable to integrate the electron source into a food treating apparatus, such as a cooking apparatus such as a pot, a grill or the like. In the embodiment of disclosed by Simic-Glavaski, the electrons are provided from a relatively localized source. It would be advantageous to increase the area over which the electrons are provided in the food treating apparatus. By increasing the area over which the electrons are supplied, more electrons are provided over a larger portion of the food product. Therefore, there is a strong need in the art to improve the distribution of electrons into a food product in a food cooking, cooling, storing, or the like apparatus and process. There also is a need to enhance the countering of the carcinogenic effect that occurs during a food treating process, such as, for example, cooking, cooling, storing, serving, etc. As used herein the term “food treating” is broadly understood to mean cooking, cooling, storing, serving, or the like, as are further described below. SUMMARY OF THE INVENTION An aspect of the invention relates to a food treating apparatus wherein an electric current is provided by an electric circuit, the food treating apparatus including a vessel and a handle, and wherein at least part of the electric circuit is integral with the handle and is operative to provide electrons to food in the vessel. Another aspect of the invention relates to a food treating apparatus having a handle and a vessel for food, comprising a circuit for providing electrons for distribution via the vessel to food, the circuit including an anode, a resistive element and a connection to the vessel, and wherein at least part of the anode is in the handle. Another aspect of the invention relates to a method of providing electrons for absorption by an oxidizing medium including the step of providing an electric current by an electric circuit wherein at least part of the electric circuit is integral with a handle and is operative to provide electrons to food in a vessel. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic cross-sectional view of a food treating apparatus in accordance with an embodiment of the present invention. FIG. 2 is an enlarged schematic cross-sectional view of the handle of the food-treating apparatus of FIG. 1 . FIG. 3 is a schematic cross-sectional view of another embodiment of a handle for a food treating apparatus. FIG. 4 is a schematic cross-sectional view of another embodiment of a food treating apparatus with a handle on the apparatus lid. FIG. 5 is an enlarged schematic cross-sectional view of the handle of the food treating apparatus of FIG. 4 . FIG. 6 is a schematic cross-sectional view of yet another embodiment of a handle for a food treating apparatus. DETAILED DESCRIPTION With reference to FIGS. 1 and 2, a food treating apparatus 10 for providing electrons for absorption by a food material 12 is shown. The food treating apparatus 10 includes a vessel 14 having sufficient volume to contain the food material 12 . The vessel 14 may be a storage container, cooling container, preparing container, warming container, serving dish or any of a variety of cooking vessels; non-limiting examples include a pot, pan, cookware, grill, skillet, kettle, dish, bowl, wok, appliance or the like and associated utensils. Non-limiting examples of utensils may include a probe, a skewer, a spit or the like. The vessel 14 may be made of any conductive material, e.g., metal, stainless-steel, iron, copper, aluminum, aluminum alloy or the like. The vessel 14 may act as a cathode. The vessel 14 may be coated with a nonstick conductive coating to prevent the food medium 12 from sticking to a surface. The food material 12 may be placed in the vessel 14 in a quantity of a medium 16 . The medium 16 may be an oxidizing medium, e.g., water, sauce, oil, fat, or other medium used in a boiling, cooling, warming, steaming, basting, skewering, sauteing, baking, roasting, frying or deep frying process or other cooking, storing, cooling, preparing or treating process. A handle 18 may be permanently or temporarily attached to the vessel 14 . The handle 18 includes a passage 20 running through at least a part of the handle 18 . An anode 22 may be contained partly within the passage 20 . An end 24 of the anode 22 is electrically coupled with a resistive element 26 . The resistive element 26 is electrically coupled with the vessel 14 by a conductive fastener 28 . The anode 22 may be made of a conductive material such as, for example, metals like copper, zinc, aluminum or some other conductive material or possibly a semiconductive material. The passage 20 includes a passage opening 30 at the surface 32 of the handle 18 . The passage opening 30 may be closed with a removable plug 34 . The conductive fastener 28 may be, for example, a flat head screw, clamp, rivet, conductive weld or the like. A circuit 35 is formed. The circuit 35 includes the anode 22 electrically coupled with the resistive element 26 , which in turn is electrically coupled with the vessel 14 . The vessel 14 acts as a cathode in the circuit 35 . When the electrolyte 36 is introduced into the passage 20 containing the anode 22 , a primary electrochemical battery 37 is formed due to the potential differential between the anode 22 and the cathode, i.e., vessel 14 . The anode 22 may be formed of a conductive material with a higher electrical potential than the electrical potential of the vessel 14 so the vessel becomes the cathode of the circuit 35 and battery 37 . The resistive element 26 may be a resistor or some other impedance that cooperates with the anode 22 and vessel 14 (cathode) to provide current flow. Thus, the vessel 14 (cathode) in circuit 35 is supplied with electrons for delivery directly into the cooking medium 16 and to the food medium 12 . Although circuit 35 is shown to include the anode 22 , the resistive element 26 and the vessel 14 (cathode), it is understood that the circuit could include other elements, for example, switches, other resistors, a capacitor, an inductor or the like. The electrochemical battery 37 produces a current wherein electrons 38 flow to a surface 40 of the vessel 14 . The electrons 38 may be absorbed by the food material 12 where the food material 12 comes in contact with the surface 40 . Excess electrons 38 flowing from anode 22 to the vessel 14 are absorbed by the food material 12 to replace electrons lost by the thermally-induced oxidation of the cooking process, and may result in the food material 12 being electron enriched at the end of the cooking process or at least in effect less electron depleted than would otherwise be the case. Although the absorption of electrons by the food material 12 is described in relationship to a cooking process, it would be understood by those skilled in the art that the invention may be used during cooling, storing, preparing or other food treating processes. Alternatively or additionally, the electrons and/or negative ions (sometimes collectively referred to herein as “electrons”) 38 may flow from the cathode, i.e., the vessel 14 all through the medium 16 to the food material 12 to be absorbed by the food material. FIG. 2 is an enlarged drawing of the handle 18 illustrating several wires and connections in the circuit 35 leading to the vessel 14 (not shown). A wire 42 from an end of the resistive element 26 is electrically coupled with the end 24 of the anode 22 by an electrical connection 44 , e.g., solder, conductive adhesive, threaded connection or by some other means as is known by those who have ordinary skill in the art. Another electrical connection 44 electrically couples a wire 46 from another end of the resistive element 26 with a first end of a wire 48 . A second end of the wire 48 is electrically coupled by yet another electrical connection 44 with the conductive fastener 28 . The wires 42 , 46 and 48 may be made of a conductive material, e.g., aluminum, copper, or the like. Further, the wire 48 may be insulated by an insulating material which encases the conductive material. Additionally, the wire 48 may be partially contained within the handle and isolated from the passage 20 containing the anode 22 . The handle 18 may be made of any material that is suitably used for cookware, etc. For example, the handle may be of an insulative material, electrically nonconductive material, thermally insulative material, thermally nonconductive material, plastic, phenolic, glass, ceramic, wood or some other material that has suitable strength and rigidity characteristics for the desired purpose or desired use with cookware, food storage containers, etc., as are mentioned elsewhere herein. The handle may be electrically conductive, e.g. metal, with suitable electrical insulation provided. The handle 18 may be formed of a substantially solid material that is drilled out to provided the passage 20 for the anode 22 . Additionally, the handle 18 may be drilled out to provide the passage opening 30 for delivering the electrolyte 36 into the passage 20 for contact with the anode 22 . If desired, the handle 18 may be molded in such a way as to provide the passage 20 for the anode 22 and also the passage opening 30 for the electrolyte 36 , as described. Additionally, the handle 18 may be drilled to provide space for the various wires and connections illustrated or may be molded to provide the various passages for the wires and/or connections. Moreover, the handle 18 may be molded directly to the respective anode 22 and wires, as well as the various connections provided, for example, as is illustrated in FIG. 2 . Such direct molding enhances the integrity of the handle and may provide for protection of the various connections between the wires, etc. To provide adequate space in the passage 20 for both the anode and electrolyte, standoffs or the like may be used to locate the anode in the passage 20 as the passage itself is defined during the molding process. These are just examples of various ways in which the handle 18 may be made and of materials of which the handle may be made. However, it will be appreciated by those having ordinary skill in the art that the handle 18 may be made of other materials and/or using other processes or methods. FIG. 3 illustrates an alternative embodiment of a handle 18 ′ of an electron generating cooking apparatus such as described above. In this embodiment, the wire 48 is mounted on an outside surface of the handle 18 ′. An advantage of this embodiment is the reduction of the number of manufacturing steps required to manufacture of the handle 18 ′. Another advantage of this embodiment is the accessability of the wire 48 and electrical connections 44 should a repair or replacement be required. FIGS. 4 and 5 illustrate another embodiment of food treating apparatus 10 ′ of the invention wherein electrons are provided to the vessel 14 via an electron source provided in a lid 50 , a cover or the like. The circuit 35 is formed by the anode 22 electrically coupled with the resistive element 26 which in turn is electrically coupled with the vessel 14 acting as a cathode as described above. In this embodiment, the resistive element 26 is electrically coupled with a conductive fastener 28 which may be permanently or temporary attached to the lid 50 . The lid 50 provides a path for the electrons to reach the vessel 14 when placed on a rim 52 which is formed on the vessel 14 . The lid 50 and the rim 52 may be made of the same electrically conductive material as the vessel 14 or another suitable material which allows the electrons to flow to the vessel 14 . FIG. 5 illustrates a more detailed drawing of the handle 18 ″. FIG. 6 illustrates an alternate embodiment of a handle 18 ″′ for an electron producing food treating apparatus 10 , for example. In this embodiment, a current source to the anode 22 and vessel 14 is provided by a solar cell 54 mounted integrally upon the handle 18 ″′. The term “solar cell” is understood to mean any device that provides an electrical output in response to one or more of visible light, UV, IR or the like. In this embodiment, solar cell 54 can produce a current of, for example, five microamps to 500 nanoamps sufficient to provide an adequate source of electrons to flow which can be absorbed by the food being cooked to maintain or supplement electron content of the food material 12 . An advantage of this embodiment is the availability of ambient energy to replace or to supplement a battery or other source. Alternatively, the solar cell 54 may be integrally formed in the handle 18 ″′ such that the upper surface of the solar cell 54 is flush with the surface 32 of the handle 18 ″′. While the invention has been described in conjunction with exemplary embodiments herein, it is evident that many equivalents, alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly it is intended to embrace all such equivalents, alternatives, modifications and variations within the spirit and scope of the appended claims.

1a

This application is a continuation-in-part of application Ser. No. 07/648,151 filed Jan. 30, 1991 now U.S. Pat. No. 5,161,801 which is a continuation-in-part of application Ser. No. 07/474,368 filed Feb. 2, 1990, and now abandoned. BACKGROUND OF THE INVENTION This invention relates to an amusement device and, more particularly to, a sliding puck game and method for playing the game. Heretofore, table games using a bat and a sliding puck have been utilized needing two players to compete. U.S. Pat. No. 3,773,325 and U.S. Pat. No. 3,887,187 cover the Air Hockey Table and require two players to operate the game. Scoring is accomplished by the puck being driven into the opposing side's goal. The puck is then retrieved by the players and set upon the table to be played again. Scoring is accomplished by electrical means and indicated on the sideboards. Here the game requires two players to operate the table while the locking out mechanism at the end of the game can be overcome by obstructing the goal at each end. The game can be played continuously without interruption except for scoring on the scoreboard. U.S. Pat. No. 3,228,688 also discloses a game requiring two players. Although the game is scored electrically, it is conceivable to play the game using two players without initiating the scoring system. The game is intended to be used as a operated game. U.S. Pat. No. 4,032,150 is a two player game that does not lend itself to coin operation. The scoring end of the table, the puck and the paddles are constantly available to be played by anyone that happens to be in the vicinity. Once again, the game cannot be played by an individual player and requires two players to compete against one another. U.S. Pat. No. 3,871,585 discloses a frictionless game table that uses a round ball that rolls back and forth on a table. However, this table may present problems when a puck is used as the game's playing object. The puck when slowly propelled toward the side of the table may become stuck and may stop sliding. This stoppage would interrupt the game. Another surface sliding puck game is disclosed in U.S. Pat. Nos. 2,634,130 and 2,505,238. The games have a projectile device that travels from one end of a table to the other. However, when a puck is used on these tables it may become entrapped under the backboard at one end of the table if not projected with adequate velocity. Further, these games have the drawback that when the game ends, the player may have to walk up to the far end of the table to recover the projectile device before beginning the next game. SUMMARY OF THE INVENTION Accordingly, several objects and advantages of the invention are proposed including a puck and bat game table which utilizes high speed, single player action incorporating a high speed rebound mechanism. An object of the game is to require skill and speed to achieve a high score on a vertical display board within a given length of playing time. This puck and paddle device requires only one player to operate the game. Additional objects of my invention are to provide the basic sloped game table for high speed scoring and play, with the added possibilities of replacing the basic game with additional games varying the timing requirements and the scoring techniques. A further object is to use optics with a reflective game table surface to sense the movement of the puck to provide more accurate and reliable puck detection. These and other objects are accomplished by placing a puck on a sloping table with a backboard at the table's highest elevated end. The game player stands at the lower end of the table. The player then continuously hits the puck against targets located adjacent the backboard. If the player misses the puck, the puck lands in a penalty area adjacent the lower end of the table. In one game, ten targets and associated target lights are active. Optic beams are directed at targets on preset locations on a reflective material adjacent a rebounding device on the top surface of the table. The reflection of the optic beam is sensed by an optical detector. When the puck passes across the beam the optical detector senses the absence of the reflection and provides an electronic signal indicator. The electronic signal is fed to the display to provide an indication to the game player that the target has been hit. As the puck strikes each target it records a hit and extinguishes the light to make it inactive and a score of "1" is recorded on the scoreboard. After hitting the tenth target the scoreboard shows a score of ten. The targets then recycle such that all the targets and lights become active again. During operation the pucks hit the targets extinguishing the lights and scoring on the scoreboard. The game operation continues until such time that the timer stops the play action electrically and lowers the rebound gate to capture the puck. The accuracy of the player and the speed with which he delivers the puck before the rebound gate opens to capture the puck results in his highest score. Once the rebound gate captures the puck, the puck is fed down a chute where it is stored until the game is to be played again. To play the game again the game player inserts a coin into the slot, allowing the puck to be discharged at the same side of the table where the game player is located. Thus, the game player does not have to retrieve the puck from the backboard end of the table. Additional games using the same basic game table configuration with a different scoreboard and electronic circuits could be as follows. In a further game, the number of targets are increased to thirty with ten indicator lights in which three of the targets are tied together electronically and represent a single light. On the first hit of the target, that is, one of the three targets, that particular light would be extinguished, making that particular target inactive. The thirty targets occupy most of the width of the target area so that on the first strike, it not only extinguishes that light, but starts the count on the clock. This gives the novice a chance to eliminate all ten lights on the first go-around. On recycling the targets for the second go-around, one of the targets is eliminated from the three that are assigned to each target light. This leaves a space between target areas that could be missed by the inexperienced player, thereby reducing the potential score. On the third recycle of the targets, since only one target is available to be hit, greater accuracy on the part of the player is required to achieve a high score. Subsequent recycling would be with the single target available for each target light until the conclusion of the playing time. In another embodiment of the invention, upon acceptance of the coin by a coin slot on the game table, the rebound gate is raised, and a single target and its associated light are illuminated. The player hits the puck. Upon a first strike by the player of a rebound gate, a hit of the target, or movement of the puck over a preset location on the top surface of the table, a timing clock is initiated. The scoreboard records a hit by the puck on the target with "2" points and a miss of the target is counted as a "-1" and recorded on the scoreboard in another display indicating the number of strikes that are achieved. That is, of the ten passes at the targets, if five of the passes were hits for a count of two each, and if five were strikes or misses, the total score on the scoreboard would be "5." That is, two points for each of the five hits minus one point for each of the five misses equals a total of five. In another suggested game, once again a single target is illuminated and upon being hit, the target will be randomly shifted to one of the other positions. Again, the total running time of the game is predetermined. A hit on the target is recorded on the scoreboard as "5", a strike or a miss of the target is recorded as "1" in a second window on the scoreboard. A third window shows the total score which is multiplication of the number of hits times the number of strikes. For example, one hit at five points times ten strikes at one point each would give you a total score of 50. It becomes obvious that the number of variations in the basic game table are innumerable as long as it involves the total running time, the hits that are made on the targets and the strikes of the backboard. The game might conceivably be played using two bats, two pucks, pucks of smaller diameters, paddles with smaller puck contact faces, and two or more active targets. The game playing levels from novice to expert are determined by the padded face size and the puck diameter in play. The puck diameter is dependent on the maximum and minimum puck size that will pass through the capture and return system. With an appropriate scoreboard and associated detection circuitry, competitive team play can be promoted. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the game table incorporating the invention; FIG. 2 is a cross-sectional view of the game table cut along line 2--2 of FIG. 1; FIG. 3 is a cross-sectional back view of the game table shown in FIG. 1 with a captured puck moving in the backboard and sideboard; FIG. 4 is a perspective view of the rebound gate shown in FIG. 2; FIG. 5 is a schematic diagram of the electronic target hit and indicator circuits for the game table shown in FIG. 1; FIG. 6 is a block diagram of the electronics for the game table shown in FIG. 1; and FIG. 7 is a cutaway view of the game table shown in FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, a typical embodiment of the proposed game table 10 is shown. Sloping game table 10 with associated scoreboard 34 is mounted on a suitable base to elevate it to a typical height of 30 inches at the player end of the table. The game table 10 typically is rectangular in shape. All external surfaces are typically of a 3/4 inch sheet of plywood material. The game table surface 14 is a low friction surface with respect to the playing puck 12. The slope of the table is interdependent on the sliding friction of the puck 12 on the game table 10. In this case, the slope of the table is in the order of 2.5 inches of incline to every foot in length. The criteria for the slope of table surface 14 is assurance of the return of puck 12 to the player end of game table 10 under static conditions and provide sufficient magnitude to assure the return of puck 12 in puck return chute 38. Also resting on table surface 14 is paddle 16 which is used for striking puck 12. A puck dispenser 22 at the front base of the table dispenses playing puck 12 upon activation of the game by depositing a coin. A bat or paddle 16 and puck 12 are of a molded ABS plastic that is black in color. Sloping surface 14 is white HDPE plastic for a contrast between table surface 14 and puck 12, and provides a substantially frictionless surface. The detection technique of recording and displaying hits and strikes is optional. That is, electrical, mechanical, magnetic, optical or any sensing technique can be employed. The method of displaying strikes and hits and playing time or combinations thereof is also optional. Electrical, mechanical, electronic, etc. programming of the game is optional. That is, the number of possible variations of games the game table is capable of is unlimited. Referring to FIG. 1, the face of scoreboard 34 houses clock 32 with its time preset to a given playing cycle. One revolution is typically thirty seconds which results in the termination of the game. Scoreboard display window 28 is a numeric display. The quantity of score display windows 28 will be increased depending upon the variations of the game. Low voltage target indicators 26 are positioned along the bottom face of scoreboard 34 and are active target hit strike zone areas. Referring to FIG. 2, game table 10 is bounded on either side by low guard rail 20 just above playing surface 14 of table 10. Penalty box 18 is bounded by player guard rail 24 to keep puck 12 from coming off table 10 at the player end. Penalty box 18 is a gutter adjacent and having a level below playing surface 14 at the player's end of table 10. The elevated scoreboard 34 houses target indicators 26 and an optional operational circuit. An opaque target area cover 30 is typically 15 inches in length and covers the full width of table 10. Rebound gate 40, shown in a closed position, is activated by solenoid 42 to the open 40A position at the termination of play to capture puck 12. With rebound gate 40 in the open 40A position, puck 12 is directed to puck deflector 48. Puck guide 50 directs puck 2 to backboard incline 52. Puck 12 rolls on its edge to guardrail void 72 in the backboard incline guardrail 60. Gravity forces puck 12 to drop onto vertical to horizontal puck ramp 61. Puck 12 is rotated to align with and roll down puck return chute 38. Puck 12 is then held at puck release solenoid 36 until released at the initiation of the next game. Referring to FIG. 2, FIG. 3 and FIG. 7, puck 12 progresses in the following sequence when captured. At the end of the timed play rebound gate 40 opens to 40a position directing puck 12 to puck deflector 48 and puck guide 50. Puck 12, now in a vertical position, rolls on it's edge down backboard incline 52 to drop through guard rail void 72. Vertical to horizontal puck ramp 61 deflects puck 12 to a horizontal position. Puck 12 is then directed by the curved horizontal to vertical puck ramp 64 to puck return chute 38. The critical components to assure pivoting of puck 12 and alignment with puck return chute 38 are the vertical to horizontal puck ramp 61 and horizontal to vertical puck ramp 64. Referring to FIG. 4 and FIG. 7, the rebound gate 40 assembly is formed using a 1/4 inch, diameter steel rod 40 that exceeds the dimension of the puck rebound band 70, thereby effecting a spring to rebound a puck on impact. The puck rebound band 70 is preferably constructed with a 1/2 inch polypropylene strapping. Gate pivot hinge 46 supports rebound gate 40 and allows an open rebound gate 40a position at the termination of a game by deenergizing gate solenoid 42 resulting in band 70 lowering. This puck may slide overboard an into backboard incline 52. Referring to FIG. 5, there is shown an optional circuit of one of any number of target hit indicator detectors. In this case there are ten detectors depicted. All electrical contacts are common or in parallel to one another. A trigger electrical pulse applied to on gate 63 and base of photodarlington transistor 62 resulting in photodarlington transistor 62 being enabled. In response to photodarlington transistor 62 being enabled, current flows through resister 59 to target indicator 26 and light emitting diode 66. Referring to FIGS. 2 and 5, photodarlington transistor 62 detects when puck 12 interrupts the focused energy beam of light emitting diode 66 reflecting off of reflective material 99 on game table surface 14. This reflective material may be embedded on surface 14 of the table or may be a tape that removably adheres to table surface 14. Preferably, reflective material 99 extends laterally across table 14 from one side to the other. Photodarlington transistor 62 breaks a circuit so as to indicate a hit when a puck crosses over reflective material 99 and intercepts the beam. Target indicator 26 responds to the broken circuit by going out. A score is then recorded on scoreboard 34 through coupling capacitor 65. Count out terminal 56, positive terminal 57, negative terminal 58, and on gate terminal 63 are common to all target hit indicator detectors. Target indicators 26 are re-excited by a pulse at on gate terminal 63 by the circuit program or the next game. Referring to FIG. 6, a typical block diagram of the circuit for the game is shown. With power applied to the game, reset activation of the game is commenced by placing a coin in a slot which in turn resets target indicators 26, raises rebound gate 40 and releases puck 12 for the play. The player places puck 12 on game table surface 14 and pushes puck 12 toward target indicators 26 with paddle 16. First strike of puck 12 interrupts the beam of optoelectronic puck detector 68 and activates clock 32 to start the allotted running time on the scoreboard. Interruption of the light beams between light emitting diode 66 and transistor 62, and of optoelectronic puck detector 68 by puck 12 extinguishes respective target indicator 26 and a hit is recorded. Puck 12 comes in contact with puck rebound band 70 and is deflected back to the player. In one version of the game, a reset is initiated after all ten target indicators 26 and associated gate sensors in transistor 62 and diode 66 have been hit. A score is recorded on score window 28 and target indicators 26 are re-excited for continuation of play until such time as timing clock 32 is turned off. Rebound gate 40 is lowered and puck 12 is captured and held in return chute 38 by puck release 36 until another coin has been placed in the slot to re-initiate the game. One such puck release mechanism is a solenoid. When another coin is placed in the slot to re-initiate the game, a signal is sent by a coin capture mechanism (not shown) to enable puck release 36. Puck release 36 then retracts allowing puck 12 to slide down return chute 38 into puck dispenser 22. Although coin capture mechanism is not shown, this device is preferably a known coin capture mechanism and is mounted on the side of game table 10. Referring to FIG. 1, inclined table surface 14, puck 12 and paddle 16 are of a low friction material. Table 10 perferably has an inclination as previously described to prevent the puck from sticking to the table during game operation. A player, after activating the game by depositing a coin, receives puck 12 from puck dispenser 22. Timing clock 32 and the score are set at zero. Target indicators 26 are all illuminated. The contestant places puck 12 on game table surface 14 and with paddle 16 hits puck 12 towards target indicators 26. The object of the game is for puck 12 to strike one of the target indicators 26 and extinguish it. The first impact of puck 12 initiates the beginning of the allotted playing time. Scoreboard 34 continues the action of clock 32 and score display window 28 as each target indicator 26 is extinguished. Guard rail 20 prevents puck 12 from being ejected from playing surface 14. Cover 30 increases the apparent speed as puck 12 is returned to the player. Should the player miss puck 12 with paddle 16, puck 12 will be captured by penalty box 18 and player end guard rail 24, thereby causing the player to lose playing time on scoreboard 34 while clock 32 continues to run. This concludes the description of the preferred embodiments. A reading by those skilled in the art will bring to mind various changes without departing from the spirit and scope of the invention. It is intended, however, that the invention only be limited by the following appended claims.

1a

BACKGROUND [0001] The disclosure is directed to a new and distinct cultivar of Cannabis Sativa plant named ‘Midnight, characterized by an almost equal or substantially the same amount of Cannabidiol (CBD) concentration to Tetrahydrocannabinol (THC) concentration. SUMMARY [0002] Provided herein is a new and distinct Cannabis Sativa L. plant named ‘Midnight’, having an almost equal ratio of Cannabidiol (CBD) concentration to Tetrahydrocannabinol (THC) concentration, as illustrated and described herein. BRIEF DESCRIPTION OF THE DRAWINGS [0003] FIG. 1 illustrates a single fully grown plant of the variety; [0004] FIG. 2 illustrates a single leaf of the variety; [0005] FIG. 3 illustrates a flowering plant in close-up; and [0006] FIG. 4 illustrates a dried bud. DESCRIPTION [0007] This invention relates to a new hybrid marijuana plant, Cannabis sativa L. ssp. indica named Midnight. The Midnight is a medicinal variety of marijuana notable for an almost equal ratio of Cannabidiol (CBD) concentration to Tetrahydrocannabinol (THC) concentration. In other words, the ratio is substantially close to 1. [0008] The present plant was developed over 3 years through selective breeding from parents of unknown provenance in Birya, Israel. Propagation occurs from seed, but large scale production generally occurs through asexual propagation using stem cuttings. The plant may be grown outside in a normal warm summer, including many locations below 50N and virtually all climates below 45N. PLANT Exposed Plant Structure [0009] The Plant is an annual, dioecious plant with bush-like stature. The natural height at 5 months old of indoor growth is ˜150-160, and ˜170 cm outdoors [0010] A detailed list of characteristics follows: Botanical classification: Cannabis sativa L. ssp. indica Parentage unknown Propagation: Stem cuttings. Time to initiate roots—in summer: Plant description: annual, dioecious flowering shrub; multi-stemmed; freely branching; removal of the terminal bud enhances lateral branch development. Root description: Short taproot (less than 30 cm). Medium to fine, dense lateral roots; white in color, brownish when “potbound” (rootbound). First Year Stems [0000] Stem Strength—lateral stems are strong but benefit from being staked during flowering. First year stem color—young stem: 144C; older stems: 144A (The Royal Horticultural Society Colour Chart, 1995 Ed.), First year stem diameter between about 2.5 cm and about 4.5 cm. First year trunk diameter—between 7.0 cm and 8.0 cm at the soil line. Foliage Description [0000] Branch description—branches are short, densely branched with short, broad leaflets. Leaf Arrangement—palmately compound (digitate) leaves with 8 or 9 leaflets per leaf. This plant has an above-average number of leaves Texture (upper and lower surfaces). Upper surface scabrid with non-visible stiff hairs; lower surface more or less densely pubescent, covered with sessile glands. Color of emerging foliage (upper surface). A cross between 144A and 144C (The Royal Horticultural Society Colour Chart, 1995 Edition.) Petiole length −8.8 cm. Average internodes' length (lower half of plant) 5-6 cm, internodes' length (upper half of plant) 4 cm Venation pattern—Palmately Compound (Digitate), with serrated leaflets. Each serration has a lateral vein extending to its tip from the central (primary) vein of the leaflet. In the middle leaflet, there is occasional double serration. From each lateral vein there is usually a single spur vein (sublateral vein) extending to the notch of each serration, but occasionally two spur veins. Vegetative Bud Description [0000] The lower flower buds can become too shaded by the leaves, resulting in a lower yield. This plant is particularly bushy for a sativa. The flower buds are highly resinous. Dried buds are dense and compact. There is a high density of trichomes; the visual appearance is ‘sparkling’, especially on the inner section of the dried buds. Dried buds are dense and compact. There is a high density of trichomes; the visual appearance is ‘sparkling’, especially on the inner section of the dried buds. Flower Description [0000] Inflorescence: Cone- or head-like, dense cluster of false spikes with solitary flowers instead of cymes. Enclosed by glandular, beaked bracteole. Flowers are often paired. Petals are absent. Calyxes are densely covered with trichomes, slight purpling of calyx and of primary veins of surrounding leafs. Wet Flower Color: wet flower buds have many long white pistils, which become brown a week before harvest. Dried flower color—Dried flower buds are a medium to dark green, with orange-brown hairs. Spike length—ranges between 5 cm and 20 cm; Pistils description—white, mid-sized, brown at maturation. Flowering time—8 weeks Peduncles [0000] Strength: Strong, but can bend horizontally from weight of flower buds. Texture: Moderately smooth, glabrous. Pedicels description: Short, scabrid with sessile glands and visible hairs. [0038] Seeds may be acquired through STS breeding. This involves inducing a female plant to become a male plant by altering its hormones using (in this case) silver nitrate and sodium thiosulfate. The male plant may then be used to pollinate a female of the same variety and collect the seeds. The relative proportion of male plants is low/medium. [0039] The plant variety is similar to the Avidekel, both having high CBD content. The dried buds also have similar drying and storing properties including high mold resistance, high trichome density. [0040] The inflorescences (flower buds) of this plant contain an almost equal ratio of CBD:THC (Approximately 12.4:12.7). When these two cannabinoids have an equal ratio, they work together synergistically for optimal medicinal benefits. [0041] This strain is very versatile. It can be used to treat a wide range of health disorders. It has many beneficial medicinal qualities. Some uses include: Stimulant Anti-inflammatory Pain management Digestive disorders Sleep disorders Anti-nausea and vomiting (increases appetite) Tourette syndrome Parkinson's disease Spasms Post traumatic stress disorder (PTSD) [0052] This plant requires frequent watering. [0053] Rooting hormone and synthetic pesticides are used in propagation. This variety has high pest and disease tolerance [0000] USDA Plants Growth Habit Code FB Vigor 5/5 Productivity Moderate to high productivity Flowering timing 9 Weeks Flowering score 7.5 Branches Weak Fruit Slightly swolen THC level 12.7% CBD level 12.4% [0054] A crop was grown having the following times of growth cycle operations: [0000] date of cutting/or from seeding 21 Apr. 2011 date transferred to cones pot of 0.8 liter 27 Apr. 2011 Date of moved to pot of 11 liters 23 May 2011 Date of taking clones 03 Jun. 2011 Date - start to flower 20 Jun. 2011 Ending flowering 21 Aug. 2011 wet flowers (grams) 494.7 wet leaves (grams) 212.5 wet branches (grams) 211.8 dry flowers (grams) 137.8 Mothers  2 meter Pot size 25 L [0055] Permits are required for growth of medical marijuana in certain states in the US and Israel.

1a

BACKGROUND OF THE INVENTION [0001] The present invention generally relates to a styling station. More particularly, the present invention relates to a portable and interchangeable shelving system capable of adaptively attaching to multiple chair backs. [0002] Professional hairstylists and makeup artists (collectively “professional stylists”) typically require the use of many types of beauty products (e.g. makeup, scissors, styling gel, shampoo, etc.) and electrical hand-held appliances (e.g. blow dryers, curling irons, etc.). Workstations that store these beauty products and electrical appliances are generally known in the art and tend to vary extensively by design. In general, designs include workstations that organize power cords via retractable extension cords, large portable workstations and workstations having rigidly attached styling trays. There are many different types and forms of styling workstations available to professional stylists. But, there are currently no customizable and highly portable workstations widely used in the industry that are capable of adaptively storing beauty products and electrical appliances according to the specific needs of the professional stylist. [0003] Workstations may incorporate one or more various devices that organize hairstyling products, makeup products and electrical appliances. Beauty products and other electrical appliances associated with hairstyling and makeup artists, hairdressing studios and hairstyling emporiums are ideally easily accessible to the professional stylist to ensure efficient styling. It is no surprise, therefore, that there are many special purpose workstations and styling trays that endeavor to solve a plurality of problems in the art. Professional stylists, especially those in the entertainment industry, often treat the skin and style hair, scalp, coiffure, wigs, and other accessories with a wide variety of products and procedures. These professional stylists need specialized workstation aids in order to provide exceptional and efficient styling services. Such workstation aids might include styling trays that organize products, devices that organize electrical cords or housings that shield the heating elements from a curling iron or blow dryer. [0004] In one example, U.S. Pat. No. 3,245,716 to Danner discloses a styling tray rigidly mounted to a chair backrest. The styling tray is designed to efficiently disconnect from the chair backrest with minimum effort. The tray is vertically and horizontally adjustable via a set of sliding brackets of which some are rigidly screwed into the chair backrest. The tray is preferably placed directly behind the backrest to best accommodate the busy professional stylist. Such a tray has multiple receptacle portions for accommodating a variety of beauty products and hairstyling appliances. Removing the tray from the chair backrest allows the professional stylist to clean the tray. But, such a tray is not highly portable and is not usable with chairs that do not have brackets mounted thereto. [0005] Another specific workstation design solves problems associated with storing and shielding dangling electrical cords of electrical appliances. This workstation includes a number of receptacles designed to hold electrical appliances, such as a blow dryer or curling iron, during non-use. Each receptacle has a charging plug from which the electrical appliance may draw electricity. The charging plug has a corresponding exposed adapter capable of being unwound to increase the operational distance of the electrical appliance. A set of electrical containers may be removably disposed in the receptacles and have varying interchangeable designs for storing other beauty products or tools. [0006] U.S. Pat. No. 5,014,371 to Heel discloses a relatively large portable workstation that includes a movable cart and electrical supply. Portable workstations are especially useful for professional stylists that work at different locations all within the same general site. Such portable workstations are generally formed from a multi-sided box-like container having a set of wheels and a plurality of slots for storing beauty products and electrical appliances. These workstations can hold and organize small beauty products and accessories such as curlers, clips, hairpins, hair and scalp treatment solutions, etc. Mounting a container to larger portable workstations, for example, increases the on-site convenience of the workstation, but can decrease portability of the workstation among multiple locations (e.g. between movie sets). [0007] In another example, U.S. Pat. No. 4,159,773 to Losenno discloses a tool hanger for supporting electrical appliances like curling irons and blow dryers. The tool hanger specifically addresses a need in the art for safely using and storing curling irons, hot comb hangers and blow dryers. Previously, such devices were placed on a vanity or other comparable and convenient surface. This significantly increased the possibility of the heating elements coming into contact with the surroundings and, in turn, increased the fire hazard. Fire hazards were especially problematic when the heating elements were accidentally left on after completed use. Thus, the tool hanger provides an electrical appliance retainer that thermally insulates the heating elements from the surrounding environment. The hangers are designed to position the heating elements away from the face, hands and other body parts of the professional stylist. But, the tool hanger fails as a versatile portable storage device capable of aiding a professional stylist outside of simply holding electrical appliances. [0008] One major problem with the prior art is that professional stylists tend to work in different environments, such as homes, styling establishments, backstage areas at theaters, movie sets, etc. Professional stylists that travel to different locations to do work may create an improvised or makeshift portable hairstyling station depending, of course, on the location, the surrounding environment and the type of work to be performed. This is particularly disadvantageous to the professional stylist as products may constantly require reorganization to create an adequate workstation for each location or work to be performed. In turn, the professional stylist may experience a decrease in efficiency and quality of work for the lack of being able to obtain certain beauty products and electrical appliances in a quick, consistent and efficient manner. [0009] Thus, there is a need in the art for widespread adaptation of a versatile styling station that aids professional stylists in performing any of the above-described services. Such a styling station should be highly portable, foldable, include an interchangeable shelving storage system, and be capable of adjustment such that the styling station may attach to a wide variety of items with simple hooks, straps and retaining rings. The present invention fulfills these needs and provides further related advantages. SUMMARY OF THE INVENTION [0010] The versatile styling station disclosed herein includes a product retainer, a pair of straps coupled to the product retainer and an attachment mechanism associated with the product retainer and the straps. The attachment mechanism connects the styling station to a base and the straps slidably adjust to level the product retainer once connected. Preferably, the straps comprise a continuous strip of flexible material that encompasses the outer portion of the product retainer. The shape of the product retainer effectively gives the styling station its shape. The styling station may further include a product holder slidably receivable by the product retainer. In one embodiment, the product holder comprises a box for storing a plurality of styling products. In another embodiment, the product holder comprises a holder capable of insulating the heating elements of a hairdryer or curling iron. The product retainer may selectively disengage the straps and may be selectively positionable along the length of the straps. In a preferred embodiment, the styling station attaches to a base that comprises a chair back, an armrest or a door. [0011] In one embodiment disclosed herein, the styling station includes an attachment mechanism that comprises an adjustable hook. The hook is selectively slidably engageable with a clip coupled to a strap. The hook further includes a lock that removably engages the clip to ensure securement thereto. In a preferred embodiment, the clip comprises a D-ring. Moreover, the hook should be sized to adaptively engage the corresponding base and may be configured to change in size depending on the corresponding application. [0012] In an alternative embodiment of the versatile styling station disclosed herein, the attachment mechanism comprises a pair of looped extensions formed from the straps. The looped extensions are sized to encompass the width of the base. Moreover, the looped extensions are adjustable and are capable of attaching to differently sized bases. In this regard, the adjustment end of the straps enables a user to increase or decrease the length of the looped extensions, depending on the size and thickness of the corresponding base to which the styling station is to be attached. Moreover, the styling station may further include a connector that selectively engages each of the looped extensions. The connector effectively prevents the straps from pulling away from one another when the styling station is attached to the corresponding base. A cushion may selectively attach to the connector to ensure that a user does not come into contact with either the connector or the straps when sitting in a chair having the styling station attached thereto. Accordingly, the cushion may comprise a lumbar support or a pillow. [0013] Other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0014] The accompanying drawings illustrate the invention. In such drawings: [0015] FIG. 1 is a perspective view of a styling station in accordance with the present invention, including a pair of hooks; [0016] FIG. 2 is a front view of the styling station of FIG. 1 ; [0017] FIG. 3 is a side view of the styling station of FIG. 1 ; [0018] FIG. 4 is a rear perspective view of the styling station of FIG. 1 ; [0019] FIG. 5 is another perspective view of the styling station of FIG. 1 , illustrating attachment to a chair back via the hooks; [0020] FIG. 6 is an enlarged perspective view of the styling station of FIG. 5 , further illustrating retainment of a plurality of hair styling products; [0021] FIG. 7 is an alternative perspective view of the styling station disclosed herein, including a pair of adjustable straps; [0022] FIG. 8 is a front view of the alternative styling station of FIG. 7 ; [0023] FIG. 9 is a side view of the alternative styling station of FIG. 7 ; [0024] FIG. 10 is a rear perspective view of the alternative styling station of FIG. 7 ; [0025] FIG. 11 is another perspective view of the alternative styling station of FIG. 7 , illustrating attachment to a chair back via the straps; [0026] FIG. 12 is an enlarged perspective view of the alternative styling station of FIG. 11 , further illustrating retainment of multiple styling products; [0027] FIG. 13 is an alternative perspective view of the styling station attached to a chair back by the pair of straps, further illustrating retention thereto by a connector; and [0028] FIG. 14 is a perspective view of the styling station of FIG. 13 , illustrating attachment of a pillow. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0029] As shown in the drawings for purposes of illustration, the present invention for a styling station is referred to generally by the reference number 10 . In general, the styling station 10 is a portable and versatile shelving system capable of adaptively attaching to multiple objects, such as chair backs. The adjustability and compatibility of using the styling station 10 in multiple settings derives primarily from the arrangement of a first strap 12 and second strap 14 that interconnect with at least one of a top shelf 16 and a bottom shelf 18 . FIGS. 1-6 illustrate one embodiment wherein the styling station 10 is removably attachable to a chair back 20 ( FIGS. 5 and 6 ) via a pair of hooks 22 . Alternatively, with respect to FIGS. 7-14 , the styling station 10 may removably attach to the chair back 20 by the straps 12 , 14 themselves. The hooks 22 enable the styling station 10 to attach to a chair back 20 , per FIGS. 5 and 6 , or any one of a number of other items, such as arm rests, doors, window sills or other pieces of furniture or parts of a building to which the hooks 22 may grasp. The straps 12 , 14 are preferably used to attach the styling station 10 to a chair back 20 in accordance with the embodiments shown in FIGS. 11-14 . Although, a person of ordinary skill in the art may use the straps 12 , 14 to attach the styling station 10 to other pieces of furniture or parts of a building in accordance with the functionality of the straps 12 , 14 , as described herein. [0030] FIG. 1 illustrates the styling station 10 including a pair of hooks 22 integral with the straps 12 , 14 via a pair of upper clips 24 . The straps 12 , 14 thread through these upper clips 24 , as described in more detail below, and may be interchanged with other straps having varying shapes and sizes. The straps 12 , 14 are preferably made from a durable and resilient material that may include leather, vinyl or rubber. Preferably, the straps 12 , 14 do not stretch. But, at least a portion of the straps 12 , 14 may stretch in order to attach the styling station 10 to an object. As best shown with respect to FIGS. 3 and 4 , the straps 12 , 14 have a first end 26 that is fixedly attached to the upper clips 24 . In this respect, the first end 26 and the upper clips 24 must also be manufactured from a substantially resilient material capable of carrying the weight of the corresponding components of the styling station 10 and any styling accessories used in conjunction therewith. Preferably, the upper clips 24 are manufactured from a rigid plastic or metal material. The first end 26 may attach to the upper clips 24 by folding a portion of the strap material about itself to form an eyelet that encompasses a portion of the upper clips 24 . Therefrom, the first end 26 of the straps 12 , 14 extends downwardly along a back section 28 of the styling station 10 . The straps 12 , 14 extend down and around a bottom section 30 of the styling station 10 , namely underneath the bottom shelf 18 . Accordingly, the straps 12 , 14 extend upwardly along a front section 32 and eventually angle upward back toward the upper clips 24 . The straps 12 , 14 then thread through the upper clips 24 and a pair of lower clips 34 slidably retained along a section of the straps 12 , 14 along the back section 28 , as best shown in FIGS. 3-4 and 9 - 10 . With respect to the embodiments illustrated in FIGS. 1-6 , an adjustment end 36 of the straps 12 , 14 folds back along the straps 12 , 14 along the back section 28 of the styling station 10 . With respect to the embodiments illustrated in FIGS. 7-14 , the adjustment end 36 is used to tighten the styling station 10 around the chair, as described in more detail below. [0031] The shelves 16 , 18 may be permanently or removably attached to the straps 12 , 14 by any mechanism known in the art, including rivets, screws, glue or by being sewn into the straps 12 , 14 . In a particularly preferred embodiment, the styling station 10 includes at least the bottom shelf 18 coupled to the straps 12 , 14 to provide support and some structure as the straps 12 , 14 themselves are generally flexible. A person of ordinary skill in the art will readily recognize that any one of a number of different shelves may be used in conjunction with the styling station 10 as disclosed herein. The shelves 16 , 18 may be fourteen inches wide by four inches deep to ensure adequate space for retaining a plurality of styling products. Preferably, the styling station 10 includes the top shelf 16 in a fixed location along the straps 12 , 14 relative to the bottom shelf 18 . In a particularly preferred embodiment, the space between the top shelf 16 and the bottom shelf 18 is ten inches. In an alternative embodiment, the top shelf 16 and the bottom shelf 18 may be adjusted by removably attaching the straps 12 , 14 thereto via a hook and loop mechanism (e.g. Velcro), snaps, snap buckles or another set of connectors that allow adjustability of the shelves 16 , 18 along the length of the straps 12 , 14 . The shelves 16 , 18 as shown in FIG. 1 include a lip 38 that generally extends upwardly approximately one-half inch from a base 40 of the shelves 16 , 18 and is approximately one-quarter inch in width. In general, the lip 38 extends around the outer perimeter of the shelves 16 , 18 and is used primarily to retain any one of a plurality of styling products placed on the base 40 . That is, the lip 38 ensures that products placed on the base 40 do not simply slide off in the event that the shelves 16 , 18 become tilted to any degree. This is particularly useful when adjusting the styling station 10 or transporting the styling station 10 from one location to another. Thus, this makes the substantially planar base 40 ideal for placement of styling products such as makeup or hair products. [0032] Moreover, the styling station 10 may include an upper bracket 42 and a lower bracket 44 for use with the top shelf 16 and the bottom shelf 18 , respectively, as shown in FIGS. 1-3 . Like the shelves 16 , 18 , the brackets 42 , 44 may also be removably or permanently attached to the straps 12 , 14 utilizing the same or a similar attachment mechanism, described above. In one aspect, the brackets 42 , 44 may be adjustably positioned relative to the shelves 16 , 18 . Adjustability of the brackets 42 , 44 allows individual professional stylists to customize the height between the brackets 42 , 44 and the shelves 16 , 18 depending on the products used with the styling station 10 . In a particularly preferred embodiment, the brackets 42 , 44 are placed approximately two inches above the respective shelves 16 , 18 . Accordingly, the space between the brackets 42 , 44 and the corresponding lip 38 of the shelves 16 , 18 is approximately one and one quarter inches. The adjustability of the styling station 10 provides more flexibility for professional stylists to customize the shelving. For example, the distance between the upper bracket 42 and the lip 38 or the base 40 of the top shelf 16 may be relatively smaller compared to the distance between the lower bracket 44 and the lip 38 or the base 40 of the bottom shelf 18 . In this example, makeup and hair styling containers of relatively short height would be placed and stored in the top shelf 16 , while makeup and hair styling containers (e.g. shampoo or hair spray bottles) having relatively tall height would be placed and stored on the bottom shelf 18 . Of course, the positioning of the shelves 16 , 18 and the brackets 42 , 44 may be configured according to the needs of each individual professional stylist. Preferably, the materials that comprise the shelves 16 , 18 and the brackets 42 , 44 are rigid and capable of being transported without wearing out or breaking. Such materials may include wood, metal, Plexiglas, Kydex, injected molded plastic products, or other materials having like properties. Of course, a person of ordinary skill in the art will readily recognize that additional removable shelving and brackets (not shown) may attach anywhere between the top shelf 16 and the bottom shelf 18 by any of the aforementioned attachment mechanisms compatible with the styling station 10 . [0033] As shown in FIGS. 5 and 6 , the hooks 22 are configured for sliding engagement with the styling station 10 . Preferably, the hooks 22 are manufactured from a resilient, yet flexible material such that a user may define the width of the U-shape portion of the hooks 22 in order to fit the styling station 10 to variously sized chair backs or other furniture items, as described above. A terminal end 46 of the hooks 22 is configured to slidingly engage the upper clips 24 for attachment thereto as shown in FIGS. 5 and 6 . The terminal end 46 is preferably curved to form a chamber through which the upper clips 24 may reside, yet not easily disengage. FIG. 3 is an exemplary illustration of the formation of the terminal end 46 of the hooks 22 such that the styling station 10 hangs therefrom and does not otherwise disengage the hooks 22 during use, especially when attached to the chair back 20 of FIGS. 5 and 6 . The terminal end 46 forms a locking chamber that prevents disengagement. The terminal end 46 may also comprise other locking mechanisms such as clips, snaps, hooks/loops (e.g. Velcro) or another similar mechanism capable of performing the same function. A person of ordinary skill in the art will readily recognize that the hooks 22 may securely engage the upper clips 24 by any means known in the art to prevent inadvertent disengagement therefrom. The adjustment end 36 of the straps 12 , 14 may simply fold back upon itself as best shown in FIG. 4 . In this embodiment, the hooks 22 attach the styling station 10 to the chair back 20 . Of course, the hooks 22 may be formed of any shape or size that enables at least partial adjustment thereof. For example, the hooks 22 may expand or contract depending on the width of the chair back or other furniture item to which the styling station 10 is to be attached. In another aspect, the hooks 22 may vertically adjust to accommodate taller or shorter chair backs or other furniture items, in accordance with the disclosures herein. [0034] FIGS. 7-14 illustrate an alternative embodiment of the styling station 10 wherein attachment to the chair back 20 is accomplished via a pair of loops 48 formed from the straps 12 , 14 . When attaching the styling station 10 to the chair back 20 ( FIGS. 11-14 ) with the straps 12 , 14 (instead of the hooks 22 ), the adjustment end 36 thereof is detached from the corresponding portions of the straps 12 , 14 as generally shown in FIG. 4 . The material of the straps 12 , 14 otherwise unused in FIGS. 1-6 is thereafter used to create the loops 48 . Retracting the adjustment end 36 back through the lower clips 34 enables this excess material of the straps 12 , 14 to expand outwardly into the loops 48 . Of course, the size of the loops 48 may be adjusted depending on the object to which the styling station 10 will be attached. The adjustment end 36 may be removably attached by any one of a number of attachment mechanisms known in the art, including a hook and loop arrangement (e.g. Velcro), buttons, snaps or clips. The loops 48 should at least initially be large enough to slide around the outside of the width of the chair back 20 . Thereafter, the loops 48 may be adjusted and tightened to the chair back 20 , as described in more detail below. [0035] As shown in FIGS. 11-14 , the loops 48 extend around the outside of the chair back 20 . Accordingly, the straps 12 , 14 may be tightened or loosened by threading more or less material through the lower clips 34 . For example, in using FIG. 9 as a reference, the loop 48 may be decreased in size by threading additional strap material through the lower clip 34 , thereby lengthening the adjustment end 36 . In this regard, the adjustment end 36 would attach to a position higher up on the chair back 20 than its current position as shown in FIG. 13 . Alternatively, more strap material may be threaded back through the lower clip 34 , thereby increasing the size of the loop 48 and decreasing the length of the adjustment end 36 . In this embodiment, the adjustment end 36 would attach to a lower portion on the chair back 20 relative to the position in FIG. 13 . Increasing and/or decreasing the size of the loop 48 depends, of course, on the size of the chair back 20 or other furniture item to which the styling station 10 is to be attached. For example, decreasing the size of the loop 48 is particularly ideal for smaller or skinnier chair backs, while increasing the size of the loop 48 is particularly preferred for larger or thicker chair backs. Tightening and loosening the straps 12 , 14 can also change the tilt angle of the shelves 16 , 18 and the brackets 42 , 44 , as described in more detail below. Of course, the straps 12 , 14 may be adjustably configured by a hook and loop configuration (e.g. Velcro), buckles, snaps, snap buckles, the upper clips 24 , a connector 50 ( FIG. 13 ), the adjustment end 36 or the lower clips 34 . Preferably the upper clips 24 and the lower clips 34 comprise a D-ring. [0036] Alternatively, the lower clips 34 may comprise a snap buckle and a set of adjustment clips located along the length of the straps 12 , 14 . In this embodiment, the adjustment end 36 of the straps 12 , 14 simply snaps into the snap buckle threaded thereon, instead of threading through the lower clips 34 . The snap buckle, like the lower clips 34 , is slidably retained along the back section 28 of the straps 12 , 14 . The size of the loops 48 may be changed through use of the adjustment clips integral to the straps 12 , 14 , instead of the lower clips 34 . In this regard, a user may adjust the size of the loops 48 with a set of three −bar adjustment clips mounted along the length of the straps 12 , 14 between the first end 26 and the adjustment end 36 . [0037] FIG. 13 illustrates the styling station 10 including the connector 50 for retaining together the straps 12 , 14 when attached to the chair back 20 . The connector 50 functions to prevent the straps 12 , 14 from falling off the sides of the char back 20 . In this regard, the straps 12 , 14 are first tightened to the chair back 20 , as described above. Then, as shown in FIG. 13 , the connector 50 attaches to the straps 12 , 14 along the chair back 20 . The connector 50 may fold upon itself for attachment thereto by any of the aforementioned retainment mechanisms, such as a hook and loop arrangement (e.g. Velcro), snaps, clips or other mechanisms known in the art. In this case, the connector 50 helps retain the straps 12 , 14 relative to one another along the chair back 20 . Without the connector 50 , the straps 12 , 14 risk pulling apart and falling off either side of the chair back 20 . Accordingly, the connector 50 may also help maintain and center the styling station 10 in the middle of the chair back 20 . [0038] Moreover, FIG. 11 illustrates a pillow 52 that may be integrated with the styling station 10 as described herein. The pillow 52 is preferably any type of lumbar support or cushion attachable to the styling station 10 via the connector 50 to ensure maximum comfort and support. In this regard, the pillow 52 simply threads into the connector 50 during attachment to the straps 12 , 14 . The pillow 52 may include a sleeve (not shown) for receiving the connector 50 or may include another mechanism, such as a hook and loop attachment (i.e. Velcro), capable of facilitating attachment to the connector 50 . When a user is sitting in a chair 54 and leaning up against the chair back 20 , the pillow 52 , as attached to the connector 50 , prevents the user from directly contacting the connector 50 and/or the straps 12 , 14 . Thus, the pillow 52 is designed to provide comfort and support to a person receiving styling services from a stylist using the styling station 10 . [0039] The straps 12 , 14 are flexible in that the styling station 10 does not need to pull tight against a back portion of the chair back 20 to operate. As shown in FIGS. 5-6 and 11 - 14 , the styling station 10 is not flush with the back portion of the chair back 20 . The design of the styling station 10 ensures that the shelves 16 , 18 are capable of being oriented according to the needs of the professional stylist. The shelves 16 , 18 are preferably positioned substantially horizontal to the floor and positioned at an offset angle relative to the back portion of the chair back 20 , unless, of course, the chair back 20 is perpendicular to the floor. Adjusting the straps 12 , 14 to shorten the distance around the chair back 20 would tighten the loops 48 therearound and cause the styling station 10 to tilt forward. Increasing the size of the loops 48 tilts the styling station 10 backward toward the chair back 20 . This tilting feature is especially useful for maximum adjustability of the styling station 10 for use with a wide variety of chairs, including angled chairs. This ensures that the styling station 10 does not simply dangle from the chair back 20 . Rather, the styling station 10 may securely attach to the chair back 20 and be properly adjusted to ensure that the shelves 16 , 18 remain substantially parallel to the floor in order to stabilize the styling products placed thereon. Hence, the professional stylist is able to work from the styling station 10 without worrying that makeup and hairstyling products, retained in the shelves 16 , 18 and by the corresponding brackets 42 , 44 , may fall out. The styling station 10 is especially useful and conformable to the pitch of different styling chairs and may attach to a hydraulic salon chair back, an ordinary chair back and any railing or doorframe with straps or hooks. Accordingly, the styling station 10 can be adjusted for different chair back heights, door heights and angles to keep the shelves 16 , 18 level. [0040] As shown in FIG. 1 , the styling station 10 may further include any one of a plurality of accessories such as a box 56 or a holder 58 . The box 56 is preferably sized to fit neatly within the interior of the top shelf 16 as formed by the lip 38 . The styling station 10 may also include a mechanism for attaching the box 56 to the top shelf 16 , such as by a mechanical mechanism or an adhesive mechanism. The box 56 may hold any one of a number of small styling accessories such as a pin 60 ( FIGS. 6 and 12 ). Of course, a person of ordinary skill in the art will readily recognize that the box 56 is capable of being placed in either the top shelf 16 , as described above, the bottom shelf 18 or any other shelves intermediate between the top shelf 16 and the bottom shelf 18 . Moreover, the professional stylist may endeavor to use multiple boxes 56 to hold a variety of other styling products requiring individual compartments. The box 56 may be larger or smaller than that shown in the representative figures and may be further customized to include smaller individual compartments therein (not shown). The box 56 is preferably flush with the corresponding bracket when placed on the base 40 of any respective shelf, as shown best in FIG. 2 . The upper bracket 42 helps stabilize the box 56 when placed in the top shelf 16 . In this regard, the upper bracket 42 prevents the box 56 from tipping or otherwise falling out of the top shelf 16 . [0041] Also shown in FIG. 1 is the holder 58 , which may retain a curling iron 62 , a hairdryer 64 ( FIGS. 5-6 and 11 - 12 ), or any other comparable styling device. The holder 58 preferably includes a horizontally extending ledge 66 . The ledge 66 enables the holder 58 to seat flush against the base 40 of the top shelf 16 through a corresponding aperture 68 . As best shown in FIGS. 4 and 10 , the top shelf 16 may include a plurality of apertures 68 , 68 ′, 68 ″. The shelves compatible with the styling station 10 may include one or more of the apertures 68 in any one of a number of different configurations. Moreover, the aperture 68 may be sized to retain one of a plurality of devices and/or specially shaped to accommodate a specific device that a professional stylist may want to use. Any one of a number of different accessories may also be used in association with the aperture 68 . For example, the box 56 covers the aperture 68 ″, as shown in FIGS. 4 and 10 . The holder 58 or another accessory may be inserted into any one of the apertures 68 , 68 ′, 68 ″. Preferably, the holder 58 is capable of insulating the heating element of the curling iron 62 or the hairdryer 64 to prevent exposure and possible burn risk. Of course, any one of a number of different sized or shaped holders 58 may be used in conjunction with a plurality of the aforementioned apertures 68 . The holder 58 is preferably made of a metal, a flexible heat resistant fabric or other fire retardant material resistant to large temperature changes that may result from direct contact with the heating elements of the curling iron 62 , the hairdryer 64 , or other similar device. [0042] The styling station 10 may also retain other items in the shelves 16 , 18 , as shown in FIGS. 5-6 and 11 - 12 , including a water bottle 70 , a hairspray bottle 72 or a shampoo bottle 74 . Of course, a person of ordinary skill in the art will readily recognize that the styling station 10 may effectively retain any one of a number of different products to aid a professional stylist. [0043] The styling station 10 is specifically designed to be detached from the chair back 20 for travel with the professional stylist in and among varying locations without forcing the professional stylist to reconfigure the styling station 10 at each of the independent locations. [0044] Although several embodiments have been described in detail for purposes of illustration, various modifications may be made to each without departing from the scope and spirit of the invention. Accordingly, the invention is not to be limited, except as by the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for treating blood plasma effective in treating autoimmune diseases, wherein a hollow fiber membrane which makes it possible to selectively remove immune complex, rheumatoid factors, etc., is employed. 2. Description of the Prior Art Various methods of treating blood such as hemofiltration with filter membranes, hemoperfusion with adsorptive agents, etc., in addition to hemodialysis using dialysis membrane have been widely employed in a field of clinical medicine. Further, a technique which is called plasma-pheresis is being developed recently as a method for treating blood by extracorporeal circulation. In the plasmapheresis, blood is first separated into blood plasma components and blood cell components and the separated blood plasma components are treated in various methods in order to remove disease factors. More particularly, there are two methods of the plasmapheresis, one is a blood plasma substitution method in which blood plasma products made of blood plasma of other persons is substituted for the separated blood plasma component, and the other is a specific plasma component permeation method wherein the separated blood plasma component is further fractionated by a suitable method and then only specific fraction which induces problems is removed and other fractions are returned to the circulation in the body. As a therapeutic method, the blood plasma substitution method does not seem to be a preferable one, because, in the method, large amounts of blood plasma products are necessary as the whole amount of the plasma component of a patient is exchanged and therefore the method becomes expensive, and vicious influences may be brought as blood plasma products can not completely supplement each physiological substance in the plasma. Meanwhile, in the specific plasma component permeation blood, since only some parts of the blood plasma are removed and the other is taken back to the circulation in the body, the above mentioned problems of the former method are much improved. Thus, this method may be said to be a better therapeutic method. There are already several studies and reports on such a specific plasma component permeation method as mentioned above. For example, there is a report on a method for treating the blood plasma using ethylenevinyl alcohol copolymer membrane (see Japanese Journal of Medical Instrumentation Vol. 49, Suppl. 259-261 (1979)). However, the ethylene-vinyl alcohol copolymer membrane disclosed therein inhibits permeation of 80 to 90% of dextran with a molecular weight of 100,000 as shown in FIG. 3 on page 261 of the Journal and has a water permeability of 20 to 34 ml/1.2 m 2 ./hr.mmHg (about 17 to 28 ml/m 2 ./hr.mmHg) which is considerably low. On the other hand, a method wherein a membrane having micropores with average diameters of 0.05 to 0.20μ piercing through the membrane and distributed uniformly on its surface and having a water permeability at a very high level of 2 l/m 2 .hr.mmHg or more is used for filtering blood plasma is described in Japanese Patent Laid Open Nos. 75163/1981 and 751 64/1981. However, such a membrane having large pores has defects that it cannot efficiently filter and differentiate low-density lipoprotein (LDL) containing a large amount of cholesterol (molecular weight: 1,300,000 to 3,200,000), human blood plasma innumoglobulin M (molecular weight: about 950,000), and proteins with a molecular weight of some 2,000,000 or less which are not precipitated by cooling (immune complex or the like). SUMMARY OF THE INVENTION It is an object of the present invention to provide an improved method for treating blood plasma, wherein hollow fiber membrane comprising at least a skin layer on one surface of said membrane and a porous layer inside the membrane is used. Said hollow fiber membrane is composed of a skin layer having micropores with average pore size of 50 to 450 A, a porous layer with pores of average size of 500 to 15,000 A, and shows void volume of 50 to 85%, and a water permeability of 80 ml/m 2 .hr.mmHg or more, and shows permeabilities for human blood plasma albumin of 85% or more and for human blood plasma immunoglobulin G(IgG) of 80% or more, and a rate of inhibition against human blood plasma immunoglobulin M(IgM) of 40% or more. Therefore, as shown in examples to be described later, use of the hollow fiber membrane having said properties in treating the blood plasma makes it possible to inhibit permeation of noxious components such as IgM (molecular weight: about 950,000), cholesterols, immune complexes or rheumatoid factors without loss of albumin and IgG (molecular weight: about 160,000) which are effective components of the blood plasma. In other words, since immune complexes rheumatoid factors or the like can be selectively removed from the blood plasma without reduction in levels of immunological performances by using said hollow fiber membrane, use of the membrane is remarkably effective in the therapy of autoimmune diseases. BRIEF DESCRIPTION OF THE DRAWING Nos. 1 to 4 of FIG. 1 are scanning electron photomicrographs at a magnification of 12,000 X showing the structure of the hollow fiber membrane for treating the blood plasma to be used in the method according to the present invention. No. 1 shows a broken section of the exterior surface of the hollow fiber membrane, No. 2 is the exterior surface of the membrane, No. 3 is a broken section of the interior surface of the membrane, and No. 4 is the interior surface of the membrane. FIG. 2 shows a system for treating the blood plasma, wherein a hollow fiber membrane module for treating the blood plasma is employed. FIG. 3 is a graph showing changes in rates of removal of normal human blood plasma components with time using said hollow fiber membrane. FIG. 4 is a graph showing changes in rates of removal of blood plasma components of a patient suffering from rheumatism with time using said hollow fiber membrane. FIG. 5 is a graph showing changes in rates of removal of normal human blood plasma components with time using a hollow fiber membrane according to a Comparative Example. DETAILED DESCRIPTION OF THE INVENTION A hollow fiber membrane to be used in the present invention comprising at least a relatively dense microporous layer (a skin layer) on one surface of the membrane and a porous supporting layer (a porous layer) inside the hollow fiber is (1) one which has a relatively dense microporous layer (a skin layer) on the exterior surface of the hollow fiber membrane and porous supporting layer (a porous layer) both inside and on the interior surface of the membrane, (2) one which has a relatively dense microporous layer on the interior surface of the membrane and a porous supporting layer both inside and on the exterior surface of the membrane, or (3) one which has a relatively dense microporous layer on both interior and exterior surfaces of the membrane and a porous supporting layer inside it. When the blood plasma is treated by pouring it into the inner side of the membrane, a membrane of an asymmetrical structure which has a relatively dense microporous layer on the exterior surface and a porous supporting layer both inside and on the interior surface of the membrane is most desirable because of its constantly high cut-off performance and water permeability which are brought about by the porous supporting layer lying both inside and on the interior surface of the membrane which plays a role of a prefilter for huge molecules such as fibrinogen, thereby preventing clogging of pores of the relatively dense microporous layer on the exterior surface. Further, the hollow fiber membrane to be used in the present invention has a water permeability of 80 ml/m 2 .hr. mmHg or more, offering an advantage that treatment of the blood plasma is completed in a relatively short time. When the water permeability is at a level of 80 ml/m 2 .hr. mmHg or less, treating the blood plasma by the extracorporeal circulation requires a long time, resulting in a severe burden for patients. A higher level of water permeability is so much preferable, and from the standpoint of clinical practices, most desirable levels of the permeability are in the rage of 150 ml/m 2 .hr.mmHg or higher. The proper upper limit of the permeability is approximately 1,500 ml/m 2 .hr.mmHg. Moreover, because said hollow fiber membrane has a cut-off performance exemplified by permeabilities for human blood plasma albumin of 85% or more, for IgG of 80% or more, and a rate of inhibition against IgM of 40% or more, the membrane permits penetration of albumin and IgG in the blood plasma and inhibits penetration of cholesterols and IgM as mentioned above. Still preferred cut-off performances are exemplified by permeabilities for human blood plasma albumin and IgG of 95% or more and 90% or more, respectively, and a rate of inhibition against IgM of 50% or more. Void volume of this hollow fiber membrane is in the range of 50 to 85%. When the void volume is 50% or lower, a water permeability of 80 ml/m 2 .hr.mmHg or more can hardly be obtained as the membrane resistance becomes too strong, and when it is 85% or higher, pressure resistance of the membrane becomes insufficient. Preferred void volume ranges from 55 to 80%. Said hollow fiber membrane has another characteristic that its porous supporting layer both inside and on the interior surface of the membrane has micropores with average diameters of 500 to 15,000 A. The porous supporting layer with such micropores has a large influence on the water permeability and cut-off performance. When average diameters of micropores are 500 A or less, the membrane resistance becomes strong and it becomes difficult to gain a water permeability at a high level and when they are 15,000 A or more, the membrane can not give the prefilter effect mentioned before on chylomicron, fibrinogen or the like and the pressure resistance of the membrane is apt to be insufficient. Shapes of the micropores in the porous supporting layer may be a network, fine voidful, honeycomb, or granular structure. The porous supporting layer may optionally contain cavities or finger-like pores. The thinness of said membrane is also one of its characteristics. The thickness of the membrane can be freely selected in the range of 10 to 200μ, preferably 10 to 90μ, and still preferably 10 to 60μ. As the membrane becomes thinner, the water permeability becomes higher advantageously. When the membrane is 10μ thick or less, it is difficult to maintain a pressure resistance at a level of 500 mmHg necessary for extracorporeal circulation. The inside diameter of the hollow fiber membrane can be selected in the range of 50 to 800μ, preferably in the range of 100 to 500μ. The relatively dense microporous layer on the exterior surface of the hollow fiber membrane to be used in a method of the present invention greatly influences permeability for water and other substances, has micropores of average core size of 50 to 450 A, and is 100 to 30,000 A thick. It is preferred that the relatively dense microporous layer forms a thin-film structure which is oriented in the longitudinal direction of the membrane. The micropores of the relatively dense microporous layer are preferred to have average diameters ranging from 200 to 400 A, and have average thicknesses ranging from 500 to 10,000 A. Among vinyl alcohol polymers such as polyvinyl alcohol or an ethylene-vinyl alcohol copolymer, polyacrylonitrile, polymethyl methacrylate, cellulose (cupro-ammonium cellulose, acetyl cellulose, etc.), or polysulfone which are used as the raw material of said hollow fiber membrane, the ethylene-vinyl alcohol copolymer to be mentioned later in Examples are preferred. The ethylene-vinyl alcohol copolymer especially suitable for use as the raw material of the hollow fiber membrane to be employed in a method of the present invention are described hereinafter. Said ethylene-vinyl alcohol copolymer may be a random, block or graft copolymer. When the ethylene content of the copolymer is 10 mol% or less, wet mechanical properties of the resulting membrane are insufficient and amounts of eluates therefrom undesirably increase, and the ethylene content of 90 mol% or more induces undesirable decrease in biocompatibility and permeability of the membrane. Therefore, ethylene contents of the copolymer of 10 to 90 mol%, especially 15 to 60 mol%, are preferable. Such ethylene-vinyl alcohol copolymer is distinguished from polyvinyl alcohol in that amounts of eluates are very small, and therefore suitable for use as a material for making membrane for hemodialysis to be conducted in the medical field. Regarding the degree of saponification of the ethylene-vinyl alcohol copolymer, unless it is 80 mol% or more, wet mechanical properties of the resulting membrane are insufficient. The degree of saponification of 95 mol% or higher is especially preferred. Usually, an ethylene-vinyl alcohol copolymer with the degree of saponification of 99 mol% or higher which means a substantially complete saponification is used. The ethylenevinyl alcohol copolymer may contain 15 mol% or less of copolymerizable monomers such as methacrylic acid, vinyl chloride, methyl methacrylate, acrylonitrile or vinylpyrrolidone, may be cross-linked by the treatment of said copolymer, before or after forming the membrane, with an inorganic cross-linking agent such as a boron compound or organic cross-linking agent such as a diisocyanate or dialdehyde, or may be acetalized at functional hydroxyl groups in the vinyl alcohol unit with an aldehyde such as formaldehyde, acetaldehyde, butylraldehyde or benzaldehyde to an extent not more than 30 mol%. It is preferable to use an ethylene-vinyl alcohol copolymer having a viscosity value ranging from 1.0 to 50 cP as measured in a solution in dimethyl sulfoxide with a concentration of 3% by weight at a temperature of 30° C. with the use of a Brookfield viscometer. When the viscosity is lower than the level mentioned above, namely, when the degree of polymerization is lower, mechanical properties necessary as a membrane can not be obtained and when the viscosity is higher than said level, formation of the membrane gets difficult. The membrane of the ethylene-vinyl alcohol copolymer to be used in a method of the present invention can be obtained by forming a membrane from said ethylene-vinyl alcohol copolymer in a method to be described later. Said ethylene-vinyl alcohol copolymer membrane has a skin layer (relatively dense microporous layer) on one or both surfaces of the membrane, and said skin layer controls mainly permeability and cut-off performances of the membrane. Though it is extremely difficult to clarify microstructure of the skin layer, electron microscopic observations of a dry membrane disclosed that the layer had micropores with diameters ranging from 50 to 450 A. The skin layer with said structure has a porous supporting layer thereunder. The porous layer affords a sort of barrier for the skin layer and therefore the structure of the porous layer has great influences upon performances of the membrane. A method for manufacturing the hollow fiber membrane to be used in a method of the present invention will now be described. Said ethylene-vinyl alcohol copolymer membrane is obtained by dissolving an ethylene-vinyl alcohol copolymer with an ethylene content of 10 to 90 mol% in a solvent comprising at least one compound selected from the group consisting of dimethyl sulfoxide, dimethylacetamide, methylpyrrolidone and pyrrolidone, to obtain a solution with a polymer concentration (C) of 10 to 40% (by weight), and by feeding the resulting polymer solution into a coagulation bath chiefly consisting of water, to form a membrane. Selection of coagulation temperature is especially important for obtaining a membrane suitable for a method of the present invention. A close relation exists between the polymer concentration (C) and coagulation temperature (T) and the purpose ethylene-vinyl alcohol copolymer membrane can be obtained when the relation is defined in the following range; C-10≦T≦C+30, preferably C-8≦T≦C+15 Solvents for dissolving said ethylene-vinyl alcohol copolymer may be a monohydric alcohol such as methanol or ethanol, a polyhydric alcohol such as ethylene glycol, propylene glycol, or glycerol, phenol, m-cresol, methylpyrrolidone, formic acid, and those containing water. Among these, the one selected from the group of dimethyl sulfoxide, dimethyl-acetamide, methylpyrrolidone, pyrrolidone and mixtures of said substances are suitable for manufacturing a separating membrane having well-balanced water and solute permeabilities which is to be obtained in a method of the present invention. Especially, dimethyl sulfoxide which can dissolve the ethylene-vinyl alcohol copolymer therein at a high level is preferable. In dissolving the ethylene-vinyl alcohol copolymer in said solvent, its concentration is in the range of 10 to 40% by weight, preferably 15 to 35% by weight. Further, the temperature of the polymer solution is 0° to 120° C., preferably 5° to 60° C. When the temperature of the solution is above said range, the polymer is liable to be denatured, while when it is below said level, the viscosity of the stock solution becomes so high that the membrane formation becomes difficult. In the coagulation bath, an aqueous medium is used as a coagulating agent. The aqueous medium may be water alone, an aqueous solution containing a water-miscible organic solvent, usually the same as one used for preparing the polymer solution, in a range of not more than 70% by weight, or said aqueous solution to which is further added an inorganic salt such as Glauber's salt. The membrane can be manufactured above a gelation temperature of the stock solution in a wet coagulation process or in a dry/wet process where the stock solution is fed into a coagulation bath after passing air or solvent vapor. After the coagulation, wet heat processing, elongation, drying or the like, can be employed if necessary. The membrane can be used in a wet state, or after dried, and it is desirable to use it after drying in view of easy handling. Methods for drying the membrane may be drying under normal or reduced pressure below a glass transition point of the ethylene-vinyl alcohol copolymer, more preferably at around room temperature, freeze-drying where water contained in the wet membrane is sublimated under reduced pressure after freezing the membrane with liquid nitrogen, etc., or an organic solvent replacement method where a water-miscible organic solvent is first replaced for water contained in the membrane and then the solvent is removed by vaporization. In the organic solvent replacement method, a permeable membrane which maintains its permeable performance is obtained by dipping the wet membrane in a water-miscible organic solvent to replace for an aqueous medium present on the surface or inside of the membrane, and drying the resulting membrane below a glass transition point of the ethylene-vinyl alcohol copolymer, preferably at room temperature, under normal or reduced pressure. In this method, lower aliphatic alcohols or ketones having 1 to 5 carbon atoms are preferred organic solvents and, for example, methanol, ethanol, amyl alcohol, acetone, methyl ethyl ketone, or diethyl ketone can be used. Among them, acetone is particularly preferable. Drying of the resulting membrane after the replacement process is carried out below a glass transition point of the copolymer. In another way where said organic solvent is not used for replacing for water, a membrane which can maintain the permeability after formation is obtained by treating the undried membrane below 50° C. with an aqueous or alcoholic solution of a polyhydric aliphatic alcohol containning 2 to 4 carbon atoms or an adduct obtained by adding 1 to 20 mol of ethylene oxide to said alcohol, and then drying the resulting membrane below 50° C. In this method, the resulting membrane contains, in a ratio of 20 to 120%, the polyhydric alcohol or ethylene oxide adduct of said alcohol which can be easily removed from the membrane by washing after its construction into a module and before use. The polyhydric aliphatic alcohols having 2 to 4 carbon atoms may be ethylene glycol, diethylene glycol, propylene glycol, 1,3-butanediol, 1,4-butanediol, or glycerol, and glycerol is especially desirable. Said polyhydric aliphatic alcohols may also be added to a coagulating liquid to be used in a wet method for manufacturing the membrane and thus incorporated in the resulting membrane. When said membrane is actually used for treating the blood by extracorporeal circulation, the blood taken out of the artery is first devided into blood cells and blood plasma components using plasma separator (a membrane which inhibits permeation of blood cells and platelets but which permits permeation of blood plasma components, for example, a module provided with a hollow fiber membrane, or an apparatus equipped with a centrifugal separator) and the separated blood plasma component is introduced into a blood plasma treating equipment provided with a hollow fiber membrane to inhibit high molecular substances such as cholesterols, immune complexes and IgM and to take back albumin and IgG which has permeated the membrane into the vein together with blood cell components. In this case, fluid replacement (for example, albumin and hydroxyethyl starch) may also be introduced into the vein, if necessary. General conditions under which the blood plasma is treated by yhe extracorporeal circulation using said hollow fiber membrane are flow rate of the blood plasma of 10 to 500 ml/min, temperature of -2° to 45° C., and transmembrane pressure (TMP) of 0 to 2 kg/cm 2 , preferably 10 to 300 mmHg, and treating time of usually 2 to 4 hours. Blood plasma treatment mentioned above makes it possible to suitably and effectively treat such diseases as systemic lupus erythematosus, malignant articular rheumatism, familial hypercholesterolemia, or Goodpasture's syndrome. In the application of the invention, levels of water permeability, void volume, microstructure, permeability and inhibition performance are determined as follows; (1) Water permeability of the membrane, K', was obtained by the determination at a temperature of 37° C. under a transmembrane pressure of 20 to 100 mmHg. K'=V/A·t·ΔP(ml/m.sup.2.hr.mmHg) V: volume of water permeated(ml), A: area of the membrane (m 2 ) t: permeation time(hr) ΔP: transmembrane pressure under which the determination is conducted(mmHg) (2) Void volume was calculated from the following formula: ##EQU1## PD: weight of dry membrane PW: weight of water-containing membrane (measured after removal of water on the surface of the membrane which has been dipped in water in a dried state, prior to the measurement, to have water sufficiently penetrate into micropores, and then taken out from there.) (3) Microstructures were examined by scanning electron photomicrographs. Diameters of micropores of the relatively dense microporous layer were calculated using cutoff rate for standard proteins and water permeability. (4) Rates of permeability and inhibition were determined under conditions of a solute concentration of 0.1%, temperature of 37° C., TMP of 20 mmHg, QB of 200 ml/min, and membrane area of 1 m 2 . The present invention will be better understood by the following examples. EXAMPLE 1 A solution with a polymer concentration of 22% was prepared by dissolving a saponificated ethylene-vinyl acetate copolymer with an ethylene content of 33% and the degree of saponification of 99.8% in dimethyl sulfoxide at a temperature of 80° C. and removing bubbles at the same temperature. The resulting spinning solution is extruded through a ring spinneret along with N 2 gas, at a constant rate of 0.42 ml/min from an orifice for outflow of an internal coagulating agent provided at the middle of the spinneret and is coagulated in a 20% aqueous solution of dimethyl sulfoxide (at a temperature of 20° C.). Then, after washing the coagulating agent with hot water and replacing acetone for water contained in the resulting fiber, the fiber was dried at a temperature of 25° C. The obtained hollow fiber has an inside diameter of 220μ, an outside diameter of 320μ, and a membrane thickness of 50μ in a dry state. Microstructures of the obtained hollow fiber membrane were examined by a scanning electron microscope. Methods and results of the examinations are as follows Method: Broken sections were prepared by bending the hollow fiber membrane while cooling with liquid nitrogen. Then, after vacuum deposition of alloy of gold and palladium on the resulting broken sections, their photographs were taken with a scanning electron microscope, as shown in Nos. 1 and 4 of FIG. 1. Nos. 1 and 2 of FIG. 1 show a broken section on the exterior surface side of the membrane and the exterior surface of the membrane, respectively, at a magnification of 12,000 X. From these figures, it is understood that, on the exterior surface of the membrane there is a thin-film structure oriented in the longitudinal direction of the hollow fibers and that there is a porous supporting layer (with an average pore size of 800 A) under the relatively dense microporous layer about 2,000 A thick. An average diameter of micropores of the relatively dense microporous layer was found to be approximately 400 A by calculation using cut-off rate for standard proteins and water permeability. Nos. 3 and 4 of FIG. 1 show a broken section on the interior surface side of the membrane and the inner surface of the membrane, respectively, at a magnification of 12,000 X. From these figures, a porous supporting layer (with an average pore size of about 800 A) was found to exist both inside and on the inner surface of the membrane. The hollow fiber membrane had a void volume of 58%, water permeability of 240 ml/mmHg.m 2 .hr (for pure water at a temperature of 37° C.), permeabilities for human blood plasma albumin and IgG of 89% and 85%, respectively, and a rate of inhibition against IgM of 52%. A module (with an effective membrane area of 1 m 2 ) was produced by bundling 6,500 hollow fibers mentioned above and fixing both ends of the resulting fiber bundle to a cylindrical housing with a polyurethane resin. An apparatus shown in FIG. 2 was constructed of said module, blood pump, manometer, blood circuit and the like, and the blood plasma which was kept at a temperature of 37° C. was circulated in the apparatus at a flow rate of 20 ml/min. 15 minutes after starting the circulation, a Q out valve was fully closed and filtration was started. The blood plasma used in experiments was 1 l of normal human blood plasma containing tool protein, ablumin, IgG, IgM, total cholesterol, and fibrinogen in quantities of 5.4 g/dl, 3.5 g/dl, 640 mg/dl, 49 mg/dl, 110 mg/dl, and 160 mg/dl, respectively. By the time of termination of the 2-hour blood plasma filtration with both Q in (quantity of the blood plasma introduced) and Q UF (quantity of the blood plasma filtered) each kept at a constant rate of 20 ml/min, pressure (P i ) increased gradually from an initial level of 10 mmHg to 120 mmHg and was thereafter kept at an almost constant rate. Rate of removal for each component in 1 l of the blood plasma, (1-(concentration after t minutes/initial concentration))×100, changed as shown in FIG. 3. From these results, it is understood that IgM, cholesterols, fibrinogen, or the like can be separated and removed from the blood plasma with a bare decrease in levels of albumin and IgG. In FIG. 2 reference numeral 1 represents a heater-magnetic stirrer, 2 is a pump, 3 is a bubble removing and pressure supervisory apparatus, 4 is a pressure gage, 5 is a blood plasma filter (module), and 6 is blood plasma. In FIG. 3, the ordinate shows the rate of removal, (1-(concentration after t minutes/initial concentration))×100, and the abscissa shows filtration time (minutes) t. EXAMPLE 2 0.73 l of the blood plasma of a patient of rheumatism was filtered by circulating it in the same apparatus as in Example 1 equipped with the same module as in Example 1. Starting under conditions of Q in of 84 ml/min, Q UF of 20 ml/min, and P i of 10 mmHg, filtration was conducted for 2 hours with Q in and Q UF kept at a constant rate. Value of P i when the filtration was finished was 46 mmHg. The blood plasma before filtration contained total protein, albumin, IgG, IgM, total cholesterol, rheumatoid factors, and immune complex (Clq binding type) in quantities of 2.8 g/dl, 1.5 g/dl, 340 mg/dl, 80 mg/dl, 41 mg/dl, 225 RLS, and 124 units, respectively. Rates of removal for each component changed with time as shown in FIG. 4. From the figure, it was disclosed that the removal of rheumatoid factors, cholesterols, and immune complex (Clq binding type) was effectively carried out. COMPARATIVE EXAMPLE In the same manner for manufacturing a hollow fiber membrane as in Example 1 except that the temperature of a cogulation bath was kept at 10° C., a hollow fiber having, in a dry state, inside and outside diameters of 210 and 290μ, respectively, and a membrane thickness of 40μ was obtained. The resulting fiber further had an average pore size of about 450 A on the interior surface and of about 70 A on the exterior surface, void volume of 70%, water permeability of 40 ml/mmHg.m 2 .hr, permeabilities for human blood plasma albumin and IgG of 50% and 40%, respectively, and a rate of inhibition against IgM of 98%. A module was produced by bundling 6,800 hollow fibers mentioned above in the same method as in Example 1, and 10 l of normal human blood plasma was filtered by circulation in the same way as in Example 2. P i was 10 mmHg at the beginning and increased to 360 mmHg when the filtration was finished. As shown in FIG. 5, rates of removal for each component in the blood plasma increased, and therefore though it was at least possible to separate albumin from other substances such as cholesterol, the velosity of permeation was as slow as one third or less of that in Example 1 and pressure (P i ) was also not on a level suitable for the extracorporeal circulation.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of U.S. application Ser. No. 10/727,367 filed Dec. 4, 2003. FIELD OF INVENTION The present invention relates to devices that may be used to deliver therapeutic fluids to surgical wounds. More particularly the invention relates to functional sutures that may be used to emit therapeutic or bioactive fluids to the tissue surrounding the suture. In particular, the invention relates to a braided suture having an internal passageway capable of conducting a fluid along at least a portion of the length of the suture that may be attached on one end, through a connector, to a fluid source. BACKGROUND OF THE INVENTION Much benefit could be realized by delivering therapeutic fluids to the direct vicinity of the surgical wound. Reduced pain, enhanced wound healing, and reduced occurrence of surgical site infections are but a few potential benefits. However, the form and function of a device that could cost-effectively facilitate localized delivery of therapeutic fluids directly to the wound site over an extended period of time are not apparent. Intravenous (IV) delivery of medication to the patient following a surgical procedure is common practice. The physician may use an IV to deliver a wide variety of medications directly to the patient's blood stream over an extended period of time. Intravenous (IV) administration of medication is indeed a systemic method of drug delivery where the medication will circulate through the entire body before a portion of the medication is delivered to the wound site. Since much of the medication may be metabolized at other locations within the body before reaching the wound site, it is often necessary to increase the overall amount or concentration of medication to be delivered systemically with an IV in order for an efficacious amount to reach the wound site. However, in many cases, the increased concentration of medication that may provide the most efficacious result at the wound site, may not be safely delivered through an IV since toxic side effects may occur at various organs within the body. Other medications, such as certain local anesthetics, only provide an efficacious result when delivered locally and are simply not compatible with IV delivery methods. Multiple injections in and around the surgical wound, before, during and after surgical procedures have been used in an effort to deter side effects and complications associated with surgical procedures. Although the syringe and hypodermic needle provide a means for localized drug delivery, the continuous delivery of medication via injection over an extended time period is not practical. Indeed, over time the medication dissipates to a concentration below that required to achieve a therapeutic effect and additional injections must be prescribed. Moreover, in the case where the surgical wound is the local target for drug treatment, multiple injections around the wound site may be required to achieve the desired therapeutic effect. The patient may suffer discomfort and repetitive disturbance if multiple injections must be repeatedly administered. As a further draw back, with this approach, the health care professional must dedicate their valuable time and attention to repeatedly apply localized injections. In order to address the aforementioned shortcomings of the IV and injections for the localized and continuous delivery of therapeutic fluids, a number of specialized infusion catheters for use in the wound site have been developed. These specialized infusion catheters typically exhibit multiple perforations along their lengths and are connected to a reservoir and pump that contain and feed the therapeutic liquid to the infusion catheter, for example as described in U.S. Pat. Nos. 5,458,582, 5,891,101 and 6,626,885. The infusion catheter itself may be placed directly into the surgical incision and held in place by closing the wound around it. However, a greater risk of infection and compromised wound healing may be associated with this deployment method since the infusion catheter may serve as a pathway for pathogens to enter the surgical incision. More commonly, the infusion catheter is passed through the skin and subcutaneous tissue in the vicinity of the wound, leaving the tip of the catheter within the surgical incision and the body of the catheter in healthy tissue surrounding the wound. It is important to note that the implantation of an infusion catheter in this manner commonly requires the use of a cannula to puncture and guide the infusion catheter though the skin and subcutaneous tissue and into the surgical incision site. Although these catheters provide a means of continuously delivering a therapeutic fluid to the wound, a number of drawbacks exists. Many devices such as described in U.S. Pat. No. 6,626,885 require the use of cannulas and additional puncture wounds in the vicinity of the surgical wound to firmly secure the catheter in place, while others described in U.S. Pat. Nos. 5,891,101 and 5,458,582 require the use of additional sutures or a modification of the suturing procedure. Even so, the infusion catheter may not be firmly anchored and accidental removal of the catheter from the wound site by the patient is not uncommon. Alternatively, in order to reduce patient discomfort and other complications associated with catheter removal, some catheter devices such as described in U.S. Pat. No. 5,458,582 may be produced from bioabsorbable materials. However, the implantation of bioabsorbable catheters increases the amount of material that must be absorbed and metabolized by the body, and it is generally desirable to keep this bioburden to a minimum. Finally, there are significant additional costs, ranging from hundreds to thousands of dollars, associated with the use of these specialized catheters and the supporting reservoirs and pumps that must be employed for their operation. A suture that could be used for localized and continuous drug delivery could satisfy the unmet needs of the aforementioned devices. The suture is implanted into the tissue surrounding the wound, which is indeed the region that may benefit most from localized drug delivery. Further, since the suture must be present in most cases to achieve wound closure, the number of invasive procedures that a patient must suffer is not necessarily increased. Moreover, suture needles attached to one end of the suture may be used to penetrate tissue surrounding the wound and facilitate placement of the fluid infusing suture. The suture may be secured in the wound by making a knot in one end to prevent accidental removal. Moreover the flexibility exhibited by a suture is considerable greater than the flexibility exhibited by infusion catheters, consequently, the suture may be placed in a complicated pattern or in locations that would be hard to reach with a conventional infusion catheter. Although a number of benefits may be achieved if drug delivery from a suture were possible, the form and function of such a device is not apparent. The concept of hollow monofilament sutures was first disclosed in U.S. Pat. No. 3,918,455. Although this patent focused on the use of hollow sutures to facilitate attachment to the suture needle, it was also suggested that the bore of the hollow suture could be filled with a fluid at the time of its installation to expedite dissolution of the suture material or render the suture visible by X-radiography. It was further suggested that the tube could be so extruded and drawn to be converted into a microporous state. In this state, the polymer comprising the wall of the hollow suture would permit fluid contained in the bore of the suture to gradually diffuse through the wall into the surrounding tissue. In U.S. Pat. No. 5,984,933 an apparatus for suturing tissue has been described. Although the patent focuses on a method and device to facilitate endoscopic suturing, it was suggested that the suture material of the device could be solid or hollow, and when the suture material is hollow, small holes in the wall of the suture can be formed to enable medicaments contained in the bore of the suture to leach out into the surrounding tissue. Although these patents suggest that hollow sutures may be used to contain, and in some embodiments even slowly emit a therapeutic fluid, there are some critical shortcomings that remain unaddressed. First of all, monofilament sutures are flaw sensitive. The introduction of pores or perforations into the wall of the hollow suture may result in a substantial decrease in the strength performance of the suture and lead to its inability to insure secure closure of the wound. Secondly, the amount of medicine that may be contained inside of a hollow suture is small. Indeed the maximum amount of drug bearing solution that may be contained within most hollow sutures is on the order of 0.005 ml or less, whereas many commercially available drug bearing solutions are efficacious only in quantities in excess of 1 ml. For example, anesthetic agents such as marcaine, lidocaine, bupivacaine, mepivacaine and procaine are typically injected into the tissue surrounding an incision or wound in a buffer solution at an overall volume ranging from 5 to 30 ml, which is 500 to 3000 times greater than the dose that is applicable with the hollow sutures disclosed in U.S. Pat. Nos. 3,918,455 and 5,984,933. Finally, once the hollow suture is implanted into the tissue surrounding the wound, the drug delivery rate is dictated by the rate at which the fluid leaches or diffuses through the multiple perforations or pores. Active control of the drug delivery rate and continuous drug delivery are not possible. Furthermore, if an adverse reaction to the drug occurs, the suture must be excised from the wound to terminate drug delivery. U.S. Pat. No. 4,159,720 describes a means for infusing liquids into tissue. The preferred embodiment comprises a reservoir for containing fluids attached outside the body that feeds liquid to an absorbent wick. The absorbent wick may be made from materials commonly used in the manufacture of sutures and may be installed in the tissue in a variety of ways including placement inside of the incision or deployment in the tissue surrounding the wound. The invention relies on capillary action to draw fluid in and control the delivery rate. As such, fluid delivery rate may not be increased or decreased at the physician's discretion. Moreover, the rate of fluid influx will depend on the type of wicking material used and the thickness and length of the wick installed. It is also important to note that in the cases when the suture is comprised of a material or is coated with a material that is not wetted by the fluid, wicking action will not occur and the device will not function. Even when the fluid to be delivered does indeed wet the wick, one may expect the fluid delivery rate driven by capillary forces that may be evolved within a suture to be several orders or magnitude slower than fluid delivery rates achievable by other means such as IV, infusion catheter, or injection. It may be desirable to have of a suture that serves the multiple functions of wound closure and drug delivery. However, unlike the aforementioned examples of prior art, the suture should: 1) not compromise critical performance characteristics such as strength of the suture, 2) enable delivery of an efficacious volume of drug bearing solution on the order of milliliters not microliters, 3) provide a high level of drug delivery rate control and enable the physician to start or stop drug administration at his/her discretion, 4) provide a means of providing more than one type of medication that may be selected post-surgically in accord with unexpected patient symptoms that may arise, 5) function regardless of the composition and wetting characteristics of the suture material. A suture that satisfies the aforementioned criteria for wound closure and drug delivery is disclosed herein. It is important to note that while the device disclosed herein may be used in a multifunctional manner to close wounds and infuse fluids to a wound site, simpler applications where the suture acts solely as an infusing device are likewise possible and useful. Components of the suture may include a connector designed to join a fluid reservoir, such as an IV, or syringe, or infusion pump to a braided suture that contains at least one internal passageway capable of conducting a fluid along at least a portion of its length. The therapeutic fluid passes from the reservoir, through the connector, into the internal passageway and into the interstices between the multiple filaments of the braided suture. The integrity of the braided suture is not compromised in the design of this device and critical performance characteristic such as suture strength are maintained above United States Pharmacopia, USP, standards. By employing a connector to link the fluid conducting element of the suture to an external reservoir, the amount of therapeutic fluid that may be delivered through the suture may be increased to a volume that is efficacious. Moreover, by regulating the supply of therapeutic fluid, the drug delivery rate may be actively controlled and more than one type of medication may be supplied as needed. SUMMARY OF INVENTION Described herein is an active suture comprising a braided suture having proximal and distal ends and an outer diameter; and at least one passageway coaxial with at least a portion of the braided suture, and having proximal and distal ends and a diameter that is less than the outer diameter of the braided suture; wherein the distal end of the at least one passageway is disposed between the proximal and distal ends of the braided suture. Also described is an active suture comprising a braided suture having an outer diameter; and a tube coaxial with at least a portion of the braided suture, having an outer diameter that is less than the outer diameter of the braided suture and an inner diameter, and having one or more opening therein; wherein the ratio of the outer diameter of the tube to the inner diameter of the tube is greater than 1.7. Further described is an active suture comprising a first braided suture having an outer diameter and having embedded therein a coated fiber tow or coated braided suture coaxial with at least a portion of the first braided suture, said coated fiber tow or coated braided suture having an outer diameter that is less than the outer diameter of the first braided suture, and said coated fiber tow or coated braided suture having one or more opening therein. A method of administering a fluid to a wound is also described, where the wound has been closed using a braided suture having proximal and distal ends, an outer diameter, at least one passageway coaxial with at least a portion of the braided suture, said passageway having proximal and distal ends, an opening at the distal end and a diameter that is less than the outer diameter of the braided suture, wherein the distal end of the at least one passageway is disposed between the proximal and distal ends of the braided suture; and a connector attached to the proximal end of the at least one passageway; such that the distal end of the at least one passageway is at or in the proximity of the wound. Further described herein is a method of closing a wound, optionally in combination with administering a fluid to a wound, using a suture/needle assembly comprising a braided suture having proximal and distal ends, an outer diameter, at least one passageway coaxial with at least a portion of the braided suture, said passageway having proximal and distal ends, an opening at the distal end and an outer diameter that is less than the outer diameter of the braided suture, wherein the distal end of the at least one passageway is disposed between the proximal and distal ends of the braided suture; a surgical needle attached to the distal end of the braided suture; and a connector attached to the proximal end of the at least one passageway. BRIEF DESCRIPTION OF FIGURES FIGS. 1 a and 1 b are schematic representations of an active suture. FIG. 2 a is a schematic cross-sectional view along section 2 - 2 of FIGS. 1 a or 1 b displaying a fine tube at the core. FIG. 2 b is a schematic cross-sectional view along section 2 - 2 of FIGS. 1 a or 1 b displaying a fine tube at the core with a slit continuous along the length of the fine tube. FIG. 3 a is a schematic cross-sectional view along section 2 - 2 of FIGS. 1 a or 1 b displaying a coated fiber tow at the core. FIG. 3 b is a schematic cross-sectional view displaying a coated fiber tow. FIGS. 4 a , 4 b , 4 c , 4 d , and 4 e are cut away sections of the fluid emitting segments of the various embodiments of active sutures. FIGS. 5 a , 5 b and 5 c schematically represent the sequential steps used to deploy an active suture as a simple fluid infusion device. FIGS. 6 a , 6 b , 6 c and 6 d schematically represents the sequential steps used to deploy an active suture as both a suture for wound closure and fluid infusion. FIGS. 7 a and 7 b are schematic representations of the double-armed embodiment of the active suture. FIGS. 8 a and 8 b are schematic depictions of double-armed active sutures deployed in an interrupted mattress stitch pattern. FIG. 9 is a graph of fluid delivery rate plotted against the length and diameter of the internal passageway at two different applied fluid pressures. FIGS. 10 a , 10 b and 10 c are a series of images that show the time-elapsed distribution of fluid from an active suture. DETAILED DESCRIPTION OF INVENTION The invention disclosed herein is an active suture that may be used to deliver one or more therapeutic liquids to the direct vicinity of the wound, in a continuous or discontinuous fashion, over an extended period of time, without the need for additional invasive devices or procedures, without substantially increasing the amount of material that must be metabolized by the body, and without the need for investment in auxiliary devices or equipment. Deployment of the active suture in tissue may be conducted without the need for cannulas and guide wires commonly used with conventional infusion catheters. The active suture 10 , schematically depicted in FIG. 1 a , comprises a braided suture 14 with one or more internal passageway 12 capable of conducting and expelling a therapeutic fluid into at least a portion of the braided suture. The active suture may be connected to a suture needle 16 at the distal end. The internal passageway that is located in at least a portion of the suture may extend from the suture and a connector 18 may be fitted to the proximal end of the said passageway to enable fluid communication between an external fluid reservoir and the internal passageway 12 contained within the active suture. The connector 18 may be designed to directly accommodate a variety of conventional fluid reservoirs, including but not limited to a syringe, or conventional medical tubing attached to intravenous (IV) delivery systems or a variety of fluid infusion pumps, such as described in U.S. Pat. Nos. 6,626,392, 6,626,855, 5,284,481 and 5,080,652. As described in U.S. Pat. Nos. 6,626,392 and 6,626,855 an inflatable reservoir 34 produced from an elastomeric polymer may be attached in series between the connector 18 and the syringe fitting 20 . A syringe may be attached to the syringe fitting 20 and used to inflate the reservoir. A variety of commercially available fittings including but not limited to: luer locks, one-way valves, two-way valves, and T-fittings may be used. Specially made fittings that limit connection of the active suture to a specific reservoir, syringe, or fluid source may be used in lieu of commercially available fittings. Other accessory components as described in U.S. Pat. No. 6,626,855 that filter fluids or limit or block flow may be integral to the fluid source. Additional devices that measure flow rate, for example as described in U.S. Pat. No. 6,371,937, may be incorporated into the tubing used to connect the infusion pump to the active suture. Fluid may be delivered from an external fluid source, through the connector and internal passageway and out the interstices of the braided suture to tissue surrounding the suture before, during, or after the wound closure procedure. The pressures exerted on or by the external fluid source may exceed any pressures that can evolve within the braided suture due to capillary or diffusional phenomena. Further, by controlling the pressures exerted on or by the external fluid source, the supply of fluid may be regulated and the fluid delivery rate may be actively controlled. Alternatively, as depicted in FIG. 1 b , the active suture 10 may be connected to a suture needle 16 at the distal end and a connector 18 may be fitted to the proximal end of the internal passageway 12 to enable fluid communication between an external fluid reservoir and the internal passageway 12 of the active suture. The connector 18 may be designed to directly accommodate a variety of conventional fluid reservoirs, including but not limited to syringes, fluid pumps or intravenous (IV) delivery systems. As shown in FIG. 1 b , the connector may fit around both the internal passageway and braided suture of the device. A critical component of the active suture is the internal passageway for conducting fluid to the interstices of the braided suture. Transverse cross-sectional views of a braided suture taken along 2 - 2 of FIG. 1 a or 1 b that contain an internal passageway are schematically depicted in FIGS. 2 a , 2 b , 3 a and 3 b . As shown in FIG. 2 a , the lumen 12 of a polymeric tube 24 that is incorporated into a braided suture 14 may serve as the internal passageway. As shown in FIG. 2 b , the tube 24 may contain a slit or fine opening 15 along its entire length to serve as a channel for fluid egress into the braided suture 14 . Tubes used as the internal passageways that are incorporated into the braided sutures may take a variety of cross-sectional shapes including but not limited to circular, rectangular, and triangular. Likewise, the fluid conducting lumen may assume a variety of shapes including circular, triangular, rectangular, as well as cross or star-shaped. Alternatively, as shown in FIGS. 3 a and 3 b , the interstices 13 between the filaments of a fiber tow 26 or braided suture that has been coated with a continuous polymer sheath 28 , or otherwise surrounded by a polymeric tube and embedded coaxially in braided suture 14 , may serve as the internal passageway. As shown in FIG. 3 b , the polymer coated filaments of a fiber tow, or the polymer coated braided suture may serve as a stand alone fluid conducting suture as well. As depicted in the longitudinal cross-sectional view of a portion of an active suture shown in FIG. 4 a , the internal passageway 12 may terminate within the braided suture 14 at a location between the connector and the suture needle. In this embodiment, fluid would enter through the connector 18 in FIG. 1 , and travel within the proximal end of the active suture reaching location 43 of FIG. 4 a , continuing on through the internal passageway 12 , out the open end of the passageway 46 , and into the interstices of the braided suture 14 . The fluid accumulates within the interstices of the braided suture 14 , eventually reaching the surface 42 where it may be dispensed into the surrounding tissue. In an alternate embodiment, the fluid may be emitted from several locations along the length of the internal passageway. As depicted in the longitudinal cross-sectional view shown in FIG. 4 b , the internal passageway 12 , receiving the fluid from location 43 , may emit the fluid into the braided suture though one or more openings 48 along the length of the passageway as well as through the truncated end of the passageway 46 . Openings in the passageway may be of practically any geometrical shape including, but not limited to circular, oval, and rectangular. Openings may also be of different sizes or be packed more densely at one location than another to achieve different rates of fluid delivery from different locations along the suture. In another embodiment, the internal passageway, containing at least one opening 48 , may pass along the entire length of the active suture from the proximal end of the suture to the suture needle. As depicted in the longitudinal cross-sectional view of a segment of an active suture shown in FIG. 4 c , fluid entering at location 43 may be emitted from one or more openings 48 along the length of the active suture. As with the embodiment depicted in FIG. 4 b , the openings may assume a variety of geometrical shapes and may be distributed in variety of ways along the length of the suture. A continuous opening in the internal passageway, such as the channel 41 schematically depicted in FIG. 4 d , may also be used to facilitate fluid egress from the internal passageway to the braided suture and wound site. The channel may be located in a straight line, for example along the length of a tube, or may be made to spiral along the length of a tube. In this embodiment fluid may egress from any location along the length of the active suture. Finally, a braided suture that is surrounded by a tube or polymeric coating along a portion of its length, as schematically depicted in a longitudinal cross-sectional view in FIG. 4 e , may also be employed to transport a fluid from the connector 18 shown in FIGS. 1 a and b to the braided suture. It is important to note that active sutures with a combination of fluid conducting elements may be produced. For example, a fluid conducting element that bridges the space between the connector 18 and the proximal end of the braided suture, as shown in FIG. 1 a , may a fine tube. This fine tube may then fit into and be secured within a slightly larger tube embedded inside the braided suture that exhibits multiple perforations or channels along its length to form the internal passageway of the active suture. The active suture may be deployed to deliver therapeutic fluids in a variety of ways. With the simplest method, the active suture may be used to infuse a therapeutic fluid to the wound site without serving as a device for wound approximation or closure. FIGS. 5 a , 5 b and 5 c schematically represent the sequential steps used to deploy an active suture 10 as a fluid infusion device. The suture needle 16 is passed through the skin 17 and subcutaneous tissue adjacent to the wound and continues on into the incision site 21 itself as shown in FIG. 5 a . The active suture is then pulled through the hole produced by the suture needle 16 and positioned inside the incision, as shown in FIG. 5 b . At this stage, a portion of the internal passageway 12 and connector 18 remain external to the body. A knot or series of knots 23 may be tied in the proximal end of the active suture to secure it in place and to prevent accidental removal of the device, as shown in FIG. 5 b . The excess suture including the suture needle 25 are trimmed away and discarded. The incision 21 is then closed with conventional means using additional sutures, staples, or skin adhesives. In a final step shown in FIG. 5 c , the therapeutic fluid is supplied to the active suture via a syringe 22 or reservoir pump 29 . Alternatively, the active suture may be deployed to serve as both a suture for wound closure and a fluid infusion device. FIGS. 6 a , 6 b , 6 c and 6 d schematically represents the sequential steps used to deploy an active suture, of the type shown in FIG. 1 a , as both a suture for wound closure and fluid infusion. In the first step, a series of knots 23 are tied across the incision at a location in the active suture between the distal end of the internal passageway 12 and the suture needle 16 . This step in essence divides the suture into two segments, a segment to be used for wound approximation 33 and a segment to be used for fluid infusion 31 . The segment of the suture that is located between the knots and suture needle 33 is then deployed in a continuous stitch 35 to approximate tissue, as shown in FIG. 6 b . The infusion segment of the suture 31 in then placed over the line of stitches 35 , as shown in FIG. 6 c . Alternatively, the infusion segment 31 may be secured underneath one or more of the continuous stitches during the wound approximation step described in FIG. 6 b . The incision is then closed by conventional means using additional sutures, staples, and/or skin adhesives. In a final step, FIG. 6 d , the therapeutic fluid is supplied to the device via a syringe 23 or reservoir pump 29 . As an alternative to the deployment methods described above, instead of implanting the active suture at the site of the incision, the active suture may be implanted in the tissue surrounding the incision. Implantation may be conducted through the skin by using the suture needle 16 of FIG. 1 a , and 1 b , at any time before, during, or after the surgery. As a further alternative, the active suture may be implanted in any tissue that requires delivery of a therapeutic fluid regardless of the location or operative procedure, provided its presence does not cause undue trauma to the surrounding tissue. It is important to note that in addition to the method of delivering the therapeutic fluid to the wound after closure of the wound, as previously described, delivery of the therapeutic agent may occur perioperatively during the deployment of the active suture. Indeed in certain instances it may be desirable to pre-load or wet-out the active suture with a therapeutic fluid even before deployment. A further variation may involve delivery of one type of therapeutic fluid pre-operatively or perioperatively, followed by delivery of another type of therapeutic fluid post-operatively. The invention may also be embodied in the form of a double-armed suture, as schematically depicted in FIGS. 7 a and 7 b , wherein two suture needles 16 and a single connector are employed. In these embodiments, a connector 18 designed to receive fluid from an external fluid reservoir is attached either to a tube that extends from the center portion of the active suture, FIG. 7 a , or to the active suture 10 itself, FIG. 7 b , in a manner that enables fluid communication with the internal passageways 12 of the active sutures. The double-armed suture may also be deployed in a variety of ways. Schematic representation of double-armed sutures 10 used with an interrupted horizontal mattress stitch are shown in FIGS. 8 a and 8 b. In the case where a reservoir pump or other continuous fluid supply means is connected to the active suture, the rate at which the fluid is emitted from the active suture is controlled predominantly be three factors: fluid viscosity, applied pressure, and passageway design. The Hagen-Poiseuille relationship for fluid flow through a cylindrical pipe may be used to approximate the volume flow rate of the fluid through the active suture with a passageway described by FIGS. 2 a and 4 a. Volume Flow Rate=(π*Applied Pressure*Radius)/(8*fluid viscosity*Passageway length) where, Applied Pressure is the pressure exerted by the fluid source, Radius is the effective radius of the internal passageway through which the fluid passes, and the Passageway length is the effective length of the internal passageway from the connector to the location of the opening in the passageway. If an IV is used, the applied pressure may be determined by the height of the IV above the wound site where applied pressure=fluid density*gravitational constant*height of the IV above the patient. For example if the IV bag is held approximately one meter above the wound site, approximately 0.1 atmosphere (atm) of applied pressure would drive the fluid through the active suture. If an elastomeric inflatable reservoir, 34 in FIG. 1 a , is used, the applied pressure that drives the fluid through the active suture may be as high as one atmosphere. Finally fluid pumps, commonly used in conjunction with IV delivery systems, are tunable and may be used to deliver the fluid to the active suture at a variety of pressures and rates. In FIG. 9 , the Hagen-Poiseuille relationship has been used to estimate the volume flow rate of water at standard temperature and pressure (STP) through active sutures that contain tubular internal passageways, similar to the embodiment depicted in FIG. 1 a , 2 a and 4 a , with lumens having inside diameters of 50, 75, and 100 μm that terminate within the braided suture at a distance of less than 0.2 m from the connector. The solid curves of FIG. 9 represent the range of delivery rates attainable with 0.1 atm of applied pressure. Elastomeric reservoir pumps typically supply pressures on the order of 0.1 to 1 atm of pressure. The dashed lines of FIG. 9 represent the range of delivery rates attainable with approximately 1 atm of applied pressure. Both lumen diameter and length of the internal passageway strongly influence the rate of fluid flow, with smaller diameter lumens and longer passageways resulting in reduced delivery rates. It is important to note that FIG. 9 provides an estimate of drug delivery rate in the absence of knots. Knotting of the suture produces a more tortuous path for the internal passageway and can lead to slower delivery rates. In some applications, it will be desirable to tie knots in the active suture to facilitate wound closure. In many cases, a wound closure procedure, such as the procedure sequentially depicted in FIGS. 6 a , 6 b , 6 c and 6 d , may eliminate the need to tie knots in the portion of the active suture containing the internal passageway. In this way, the device may be used as both a suture for wound closure and a device for the infusion of therapeutic fluids without adversely impacting the control of fluid delivery rate. However, if a procedure is adopted which requires the use of a knot in the portion of the active suture containing the internal passageway, the internal passageway must remain intact in order for the active suture to conduct fluid past the location in which the knot is placed. If the interstices of the coated fiber tows or coated braided sutures are employed as the internal passageway of the active sutures, as schematically depicted in FIGS. 3 a and 3 b , the interstices therein will remain intact. However, if fine tubes are used in lieu of a coated fiber tow or coated braided suture to form the internal passageway, collapse and closure of the lumen can occur upon knot tying. In order to prevent closure of the lumens, tubes with sufficiently thick walls must be employed. Variables that influence the likelihood of collapse of the lumen inside of knots include thickness of the braided suture in which the internal passageway is imbedded, the stiffness of the tube, strength of the tube, and the overall tension applied in forming the knots. For active sutures that will be tied into surgically acceptable knots such as square knots or surgeons knots, preferably the ratio of the tube outside diameter (O.D.) to inside diameter (I.D.) is greater than 1.7 and more preferably, the ratio of the O.D. to I.D. is greater than 2.0 for most polymeric materials that are currently employed in sutures. The active suture may be manufactured, for example, via steps that include: production of the fluid conducting element to be used as the internal passageway of the active suture, incorporation of the fluid conducting element into a braided suture to form the active suture, attachment of the proximal end of the fluid conducting element or active suture to a connector, and attachment of the distal end of the active suture to a suture needle. Fine tubes compatible in size and form with the active suture shown in FIGS. 1 a and 1 b , for example, may be produced using conventional polymer extrusion technology. The tubes may be extruded directly to the proper size or may be extruded to a larger than preferred size and subsequently reduced in size with conventional fiber drawing techniques. If coated fiber tows or coated braided sutures are selected to serve as the fluid conducting element of the active suture, as depicted in FIGS. 3 a and 3 b , the first step in production would involve a process for coating the braided suture or fiber tow with a continuous polymer sheath. A polymer extruder may be outfitted with a die that allows a fiber tow or braided suture to pass through and as the tow or braided suture pass through the die, they become encapsulated with a polymer film. This process is similar to the wire-coating process used to coat metal wires with insulative polymers and is well-know in the art. The tubes, coated fiber tows or coated braided sutures may be subsequently processed to form holes or channels as shown in FIGS. 4 b, c and d . These openings in the fluid conducting element may be formed with mechanical methods or may be produced with precision laser equipment. It is important to note that in several embodiments, the step of forming a series of openings along the length of the fluid conducting element is optional. Indeed, the embodiment depicted in FIG. 4 a simply allows the fluid to emit through the end of the truncated passageway and does not call for openings to be formed along the length of the fluid conducting element. Once the tube, coated fiber tow or coated braided suture has been formed, it may be braided along with other fiber strands to form the active suture of FIGS. 4 a , 4 b , 4 c or 4 d . This may be accomplished by passing the tube, coated fiber tow or coated braided suture along side the core filaments of a braided suture thereby allowing the woven filaments of the braided suture to encircle the tube, coated fiber tow or coated braided suture. Alternate braiding schemes wherein the tube, coated fiber tow or coated braided suture is woven around the core filaments of the braided suture may also be envisioned. After braiding, the embodiments represented in FIGS. 4 a and 4 b may be produced by removing a portion of the tube or coated fiber tow or coated braided suture. This may be accomplished by grasping the tube, coated fiber tow or coated braided suture with precision needle holders and pulling it through the braided suture until only a portion of the tube, coated fiber tow or coated braided suture remains inside the braided suture to form the active suture. Alternatively a polymeric tube exhibiting a smaller outside diameter than that of the braided suture may be pressed into the proximal end of the braided suture. In this way, a portion of the tube, up to several centimeters, may be positioned coaxially within the braided suture, as shown in FIG. 4 a , while a portion of the same tube extends from the proximal end of the braided suture as shown in FIG. 1 a . To prevent the tube from slipping out of the braided suture a small amount of adhesive may be applied at the proximal end of the braided suture to cement the tube to the multiple filaments of the braided suture. Alternate methods for attaching tubes to the proximal end of the braided suture, involving thermal bonding or the use of shrinkable polymeric sleeves, may also be envisioned. Components of the active suture may be made from both bioabsorbable and non-absorbable materials. The sutures, tubes, coated fiber tows, coated braided sutures, adhesives, and connectors of this invention may be made from polymers that are commonly employed in the manufacture of sutures including but not limited to polypropylene, polyethylene, polyamides, polyethyleneterephthalate (PET), polytetraflouroethylene (PTFE), silk, polycaprolactone, polydioxanone, polyglycolide, polylactide, or blends of polycaprolactone, polydioxanone, polyglycolide or polylactide. Additionally, since the connectors do not necessarily become implanted in the body of the patient, they may be produced from even a broader variety of engineering polymers, including but not limited to solvent free polyvinyl chlorides, polyurethanes, polyesters, polycarbonates, polyolefins and polyamides. Fluids that may be utilized with any of the sutures described above include any therapeutic or bioactive agent or fluid, including but not limited to antimicrobial or antibiotic agents such as 2,4,4′-trichloro-2′hydroxydiphenyl ether, benzalkonium chloride, silver sulfadiazine, povidone iodine, triclosan, gentamiacin; anti-inflammatory agents, steroidal or non-steroidal, such as celecoxib, rofecoxib, aspirin, salicylic acid, acetominophen, indomethicin, sulindac, tolmetin, ketorolac, mefanamic acid, ibuprofen, naproxen, phenylbutazone, sulfinpyrazone, apazone, piroxicam, anesthetic agents such as channel blocking agents, marcaine, lidocaine, bupivacaine, mepivacaine, procaine, chloroprocaine, ropivacaine, tetracaine, prilocalne, levobupivicaine, and combinations of local anesthetics with epinephrine, opioid analgesic agents such as morphine, fentanyl, codeine, anti-proliferatives such as rapamycin, growth factors such as PDGF, oxygen rich liquids for wound healing, scar treatment agents such as hylauronic acid, angio-genesis promoting agents, pro-coagulation factors, anti-coagulation factors, chemotactic agents, agents to promote apoptosis, immunomodulators, mitogenic agents, diphenhydramine, chlorpheniramine, pyrilamine, promethazin, meclizine, terfenadine, astemizole, fexofenidine, loratidine, aurothioglucose, auranofin, Cortisol (hydrocortisone), cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisone, triamcinolone, betamethasone, and dexamethasone; hemostatic agents such as thrombin, tranexamic acid, epinephrine; as well as antithrombotic agents, biologics such as stem cells in a liquid solution, proteins, and enzymes may also be delivered through the active suture. Irrigation of the wound site may also be conducted through an active suture. An alternate method and purpose for using the active suture would be for the extraction of fluids from the wound site. By applying a vacuum through tubing that is connected to the proximal end of the active suture, body fluids may be drawn directly from the wound site thus providing a novel means of fluid removal to compliment wound irrigation procedures. Alternatively, the fluid may be drawn from the wound and analyzed to determine the condition of the wound. For example, the chemical signature of the sampled fluid may give an indication as to the progress of wound healing, or the detection of bacteria may enable early diagnosis of an infection in the wound. EXAMPLE 1 In order to demonstrate the ability of the active suture to distribute a fluid to surrounding tissue, a PET braided suture, containing a polypropylene tube that terminates within the braided suture, as depicted in FIGS. 1 b , and 4 a , was employed in an in vitro experiment wherein the active suture was passed multiple times though gelatin and subsequently connected to an IV delivery system that delivered water containing a blue pigment to the portion of the active suture that was imbedded in the gelatin. A series of time-elapsed images are shown in FIGS. 10 a , 10 b and 10 c . FIG. 10 a , taken at the onset of the experiment, shows the active suture 70 embedded in gelatin 72 . The black mark on the active suture 74 indicates the location at which the internal passageway terminates. As time progresses, the pigment 76 spreads out around the active suture as shown in FIG. 10 b . Ultimately, as shown in FIG. 10 c , the fluid spreads to encompass the entire region surrounding the wound. EXAMPLE 2 The incorporation of internal passageways into the active sutures should not compromise the tensile strength and knot tensile strength of the sutures to below standard acceptable levels if the active suture is to be used for both wound approximation and fluid infusion. The knot tensile strengths of PET braided sutures in United States Pharmacopia (USP) standard sizes of 0 and 2 that have polypropylene tubes imbedded along side their core filaments were measured according to United States Pharmacopia (USP) standard 23. Size 0 sutures contained tubes with outside diameters of approximately 130 μm and inside diameters of ˜75 μm, and size 2 sutures contained tubes with outside diameters of approximately 230 μm and inside diameters of ˜135 μm. For each test, at least 10 samples were tested per USP specifications. The performance of the PET braided sutures containing the polypropylene tubing at their core easily exceeded minimum performance requirements as set by USP standards, with average knot tensile strength values of 13.5 and 7.7 lbs for size 2 and 0 sutures respectively. EXAMPLE 3 Experimental data indicates that extruded polymeric tubes produced from polypropylene, with outside diameters ranging from 0.005″ to 0.010″, with Youngs Moduli ranging between 0.1 and 3 GPa, with outside diameters (O.D.s) that are less than 1.7 times that of their inside diameters (I.D.s) will buckle and collapse when the braided sutures in which they are embedded are tied into square knots similar in form to those commonly used in surgical procedures. Similar experiments conducted with polymeric tubes comprised of polyethylene and polytetraflouroethylene tubes with Youngs moduli ranging between 0.1 and 3 GPa with O.D. to I.D. ratios of greater than 2.3 do not collapse completely inside the square knots of the active suture and fluid can indeed be transferred through the knotted portions. For active sutures that will be tied into knots, preferably the ratio of the O.D. to I.D. is greater than 1.7. More preferably, the ratio of the O.D. to I.D. is greater than 2.0. In these experiments, the tubes were embedded in braided sutures produced from polyethyleneterephthalate (PET) fibers with USP sizes ranging from 2-0 to 5. Other variables that influence the likelihood of collapse of the lumen inside of knots include thickness of the braided suture in which the internal passageway is imbedded, strength of the fluid conducting tube, and the overall tension applied in forming the knots.

1a

FIELD OF THE INVENTION This invention relates to dental articulators and in particular to an articulator having a rigid, non-yielding structure for providing the occlusion plane required to build accurate intercuspation of teeth. BACKGROUND OF THE INVENTION The articulator of the present invention was developed as a result from studies in the field of Gnathology and, to be more specific, studies of a syndrome known as Neuromuscular Dysfunction, a syndrome which is medically and dentally related. Abnormal mandibular positioning can be translated into stress related symptoms of various kinds such as headaches, muscle spasms in the head and neck etc. I have found that a substantial amount of stress can be reduced by proper mandibular positioning. The lower jaw or mandible has a relationship to the upper jaw or maxilla. When this relationship is altered, the muscles of mastication may go into spasm. This causes those muscles that have the same nerve innervation to also go into spasm with the result that stresses may radiate throughout the head, neck and may even involve the back. The lower jaw may be overclosed (too close to the upper jaw) and/or distally displaced, (too far back in the joint or socket). Additionally, the lower jaw may deviate to one side due to interfering tooth cusps or points on the chewing surfaces of teeth that do not meet properly with the opposing teeth. The cause of jaw misclosure is usually multifaceted, i.e., loss of teeth or poor alignment thereof; natural wear of teeth; grinding or clenching of the teeth; poor tongue position, muscle unbalance between the tongue and facial muscles; chronic mouthbreathing, etc. The diagnosis, treatment and cure of Neuromuscular Dysfunction problems has been rapidly advanced in the last few years with the introduction of certain electronic instrumentation into the dental office. Specifically, this instrumentation was that developed by Dr. Bernard Jankelson and John Radke and consists of the following: (a) The Bio-Tens™, an instrument for accomplishing transcutaneous electrical neural stimulation through the fifth and seventh nerves to relax the mandibular muscles and precisely control their contractions during clinical procedures. This instrument is described in U.S. Pat. No. 3,593,422. (b) The mandibular kinesiograph (MKG), U.S. Pat. No. 3,822,694, an electronically accurate tracking instrument which easily and quickly provides the kind of factual information needed to determine the most functional individual occlusal position. (c) An Electromyograph, an instrument used to determine the degree of relaxation of a particular muscle or muscle group at rest. It also provides a precise measurement of the relative levels of contraction of several muscles during a functional act. The articulator of the present invention provides the mechanical portion of the translation of measurement from patient to the laboratory and back to the patient. SUMMARY OF THE INVENTION If it is determined that an improper relationship exists between the upper and lower jaw the muscles of mastication are relaxed and the lower jaw is closed on a trajectory that is not strained. In other words, the mouth closes where the muscles are most comfortable. The recordings from the Mandibular™ kinesiograph enable a dentist to diagnose an overclosure or malocclusion and/or an abnormal displacement of the lower jaw. The articulator of the present invention is used in developing a bite plane or splint to open the bite of the patient if there is an overclosure. In the study of 500 neuromuscular dysfunction cases, I have found that the vertical measurement in Neuromuscular centric™ from the normal crest of the gingival of the upper central incisor to the crest of the gingival of the lower central incisor is approximately 19 mm. This is a basic guideline in bringing the lower mandible into occlusion. I have found that if the measurement is 2 mm or more under the 19 mm guideline, a case of "overcloser" exists. Conversely if the measurement is 2 mm or more above the 19 mm guideline, then an "overopened" situation exists. Another 19 mm measurement is in the final reconstruction of the maxillary-mandibular case. By working from the lower jaw, I have found that from the lower anterior vestibule to the level of the lower central incisal edge is approximately 19 mm. However, these measurements could vary approximately 1 mm either way. The final measurement is done through the BIO-TENS™ and the mandibular kinesiograph which actually places the mandible in the proper vertical-antero-posterior and lateral position, the 19 mm measurement being a minor guideline in doing an initial set-up. The articulator of the present invention is sufficiently solid that it retains vertical and horizontal positions. With every change in vertical dimension of the mandible there is an accompanying change in horizontal and lateral positions. The direction and the amount varies and is unpredictable from person to person. For every millimeter the mouth closes vertically, the mandible simultaneously moves anteriorly one-half a millimeter on the average and to a lesser extent there is a position change laterally. Once the occlusal position has been registered in the patients mouth and transferred to the articulator, any change in the vertical dimension of the articulator will lose the accuracy of the horizontal position that is registered in the mouth. However, once a case is mounted on the articulator of the present invention, the vertical will not change. The articulator of the invention does not require any condylar elements as border movements do not occur during function and research has shown that the precise construction of occlusion to the relaxed neuromuscular "home plate" position is the primary criterion for successful prosthodontics. The articulator of the invention can also be advantageously used in the manufacture of orthodontal appliances, fixed and removable prosthodomtics and correcting pieces for the mouth. According to a broad aspect, the invention relates to a dental articulator having a rigid, non-yielding structure for providing the occlusion plane required to build accurate intercuspation of teeth, said articulator comprising a lower mounting plate adapted to support a mandibular model, an upper mounting plate adapted to support a maxillary model, and a centre or spine post spacing said upper and lower mounting plates from one another; means rigidly securing the lower mounting plate to the lower end of said spine post; hinge means pivotally mounting the upper mounting plate to the top of the spine post and means for locking the upper mounting plate to the spine post in rigid, parallel location with respect to the lower mounting plate. BRIEF DESCRIPTION OF THE DRAWINGS The invention is illustrated in the accompanying drawings in which: FIGS. 1-4 inclusive are skeletal views showing translation of the mandible in various vertical positions; FIG. 5 is a perspective view of the articulator mounting maxillary and mandibular models; FIG. 6 is a perspective view of the articulator with the 20° mounting plate in place; FIGS. 7 and 8 are elevation and end views respectively of the spine post; FIG. 9 is a plan view of the 20° mounting plate and adaptor; FIGS. 10 and 11 are plan and elevation views of the upper mounting plate; FIG. 12 is an elevation view of the inner condylar™ Kinesiograph (C.K.G.) mounting plate; FIG. 13 is a plan view of the outer C.K.G. mounting plate; FIGS. 14 and 15 illustrate sample Neuromuscular centric™ and centric occlusion markings; FIG. 15A illustrates movement of condyle in glenoid fossa from centric occlusion to Neuromuscular centric™; FIGS. 16, 17 and 18 are perspective views of the articulator showing various stages in obtaining Neuromuscular centric™ and centric occlusion pin points; and FIG. 19 shows the articulator with the myocentric post in place, the post being used in preventing any increase in the vertical during setting of mounting stone or in the fabrication of appliances on the articulator. GENERAL DESCRIPTION The articulator of the present invention has a "double stop" system which completely eliminates vertical height collapse. When the posterior remount pin is removed, the solid posterior stop acts independently to ensure precise maintenance of vertical height while allowing unlimited access. The neuromuscular centric™ terminal occlusion produced on the articulator results in minimal deflective contacts that trigger bruxing or clenching. Stable occlusion is therefore provided. The laboratory procedures pinpoint the terminal occlusion that occurs during mastication and swallowing. The final adjustments to eliminate any interferences during access into that occlusion are effectively, realistically and quickly done by final adjustment in the mouth. DETAILED DESCRIPTION FIGS. 1 through 4 are skeletal views of the mandible in various vertical positions. FIG. 1 shows a partial loss where the distal drive of the condyle 2 is into the back wall of the glenoid fossa 4. In FIG. 2, a total loss of vertical position is shown where the condyle 2 has been driven into the back wall 4 of the glenoid fossa and which can cause erosion of the condyle head. FIG. 3 shows a position where the condyle 2 is too far back and up into the glenoid fossa 4. FIG. 4 shows the mandible 6 in a relaxed neuromusclar or neuromuscular centric™ position where the vertical measurement from the normal crest of the gingival of the upper central incisor to the crest of the gingival of the lower central incisor is approximately 19 mm. All orthotics, repositioners and sports splints should be made to this terminal position. In the diagnosis of skeletal relation of the mandible to the skull a registration is taken by the dentist and transferred to the articulator. The mounting thus becomes a diagnostic tool. When the dentist makes a clinical judgement, a splint with accurate occlusion can be made on that mounting. If the procedure is one of full mouth reconstruction, once all the teeth have been prepared a acrylic registration of the patient is taken to the neuromuscular centric position (FIG. 4) with a BIO-TENS ™ and the registration is mounted on the articulator. The lab technician can now follow the neuromuscular technique and construct the occlusion to the neuromuscular position. With an edentulous patient, an acrylic registration is taken to the neuromuscular centric position of FIG. 4 using a BIO-TENS™. The cases are then mounted on the articulator and a 20° mounting plate then indicates to the technician where to set the teeth. Clinical and lab procedures for complete mouth reconstruction, complete dentures and splint construction to the neuromuscular position are simple and uncomplicated using the articulator of the invention. In order to relax the muscles of mastication, a gentle pulsating stimula is applied to the patient's skin for approximately one hour using the above mentioned BIO-TENS™. The muscles become relaxed and their trajectory can be traced on the mandibular kinesiograph. This enables the dentist to diagnose the incorrect or abnormal relationship between the mandible to the maxillary process. FIGS. 5 and 6 show the articulator 10 in assembled condition and FIGS. 7 through 13 show the structural details thereof. Referring to FIGS. 7 and 8, the spine post 12 is preferably formed of a rigid light metal such as aluminum and has an elongated straight body 14 with a bore 16 through the upper end thereof, a plastic bushing 18 being located in a countersunk portion 20 of the upper end. A guide rail 22 is provided along one side of the post 12 and comprises parallel channels 24 of rectangular configuration which, together with the adjacent terminal side edge 26 of the post 12, combine to form the guide 22 of "T" shape in cross section as seen in FIG. 8. This cross section provides a plurality of guide surfaces for the reception thereon of the adaptor 28, FIG. 9, which has complimentary surfaces 30 to those of the guide rail 22 and which carries the 20° mounting plate 32. The upper mounting plate 34 of the articulator 10 is illustrated in FIGS. 10 and 11. The lower mounting plate or base 35, FIG. 5, is of the same construction. Plate 34 is formed of rigid aluminum of substantial thickness and includes a planar portion 36 and hinge shoulders 38 which are align bored at 40. A rectangular spacing 42 between the shoulders is provided so that the upper end of the spine post 12 is received therein, and a steel hinge pin 44, FIG. 6, pivotally interconnects plate 36 and post 12 by aligning and being located in bore 40 of the plate and bore 16 of the post. As seen in FIG. 16, the upper mounting plate 36 can be pivoted back so that it clears the upper end of the post 12. The posterior remount screw 46 is located so as to increase or decrease the vertical location of a maxillary model to or from the 19 mm guide point. The lower mounting plate 35 is secured to the lower end of the spine post by steel locating pins 48 and 50 which enter bores provided in the lower end of the post 12, FIG. 7. FIG. 12 shows the C.K.G.™ inner mounting plate 48 which comprises a central channel 50 which snugly fits over the top of the spine post 12 (FIG. 16) and having an aperture 52 for receiving a locating pin. Plate 48 has a pair of L-shaped wings 54 extending outwardly and downwardly from the channel 50 to provide horizontal and vertical marking surfaces 56 and 58 respectively, FIGS. 14-16. The C.K.G.™ outer mounting plate 60 is shown in FIG. 13 and, like other elements of the articulator, it is formed of aluminum of substantial thickness and strength. A central, planar portion 62 is bored and threaded at 64 to receive a mounting screw (not shown) for attaching a mounting stone and maxillary model thereto as shown in FIG. 17. Like the inner mounting plate 48, plate 60 has a pair of L-shaped wings 66 which provide horizontal and vertical surfaces 68,70 respectively corresponding to like surfaces on the inner mounting plate 48. The surfaces 68 and 70 are provided with plastic bushings 72 for the reception of steel marking pins 74, FIG. 18. Referring to FIGS. 14 and 15 white tape or screens 76, 78 are applied to the vertical and horizontal surfaces of the inner mounting plate as shown in FIG. 16. As explained hereafter, these screens are used to indicate to the dentist the differences between the centric occlusion point and the neuromuscular centric™ point in both horizontal and vertical planes in the condylar-glenoid fossa area. METHOD OF OPERATION Initially a transcranial X-ray is taken of the patient and a BIO-TENS™ is used to bring the patient's jaw into its relaxed neuromuscular position. Upper and lower impressions are taken and upper and lower models are made. A Denar slideomatic facebow transfer is then used on the articulator to establish the relationship of the maxillary dentition to the horizontal reference plane so that the maxillary case can be mounted on the articulator in the correct anatomical position. The slidematic facebow provides a fast, easy and extremely accurate means of transferring the proper anatomical relationship to the articulator. The upper model is mounted on the upper mounting plate 34 using Snow White stone and the mounting screw 45. The dentist hand-occludes the lower to the upper and mounts the lower model to the lower plate of the articulator, measuring the vertical with calipers. If there is an overclosure of 3 or more millimeters the articulator is opened with remount pin to 17 mm, the measurement of the normal crest of the gingiva of the upper central to the normal crest of the gingiva of the lower central. A wafer is made using acrylic, a rolled acrylic wafer being placed on the lower teeth thereby taking up the empty space between the upper and lower models. The magnet of the M.K.G.™ is placed on the patient and readings are taken with the M.K.G.™. Models on articulator are reviewed and a bite is taken. The lower model is removed from the white stone and spaces between teeth and under cuts are filled with blocking compound. The splint is pulled and cut out. The lower model is then re-mounted using the arcylic bite, the dentist builds the splint and checks the bite with articulating paper. As shown in FIGS. 14-18 the inner myocheck mounting plate 48 is mounted atop the spine post 12 and tape screens 76, 78 are adhesively applied to the wing surfaces 56,58. With the teeth of the models in occlusion, the marking pins are used (FIG. 18) to mark centric occlusion points on the screens 76, 78 of the inner plate 48. Subsequently the acrylic bite block is mounted between the models and Neuromuscular centric™ points are marked on the screens 76, 78 of the inner mounting plate. The distance between the markings indicating to the dentist the increase in the extra capsular space from centric occlusion to Neuromuscular centric™, condyle to top wall, on the vertical screen and the increase in the extra capsular space from centric occlusion to Neuromuscular centric™, condyle to back wall, on the horizontal screen as shown in FIG. 15A. FIG. 19 illustrates the articulator with the Neuromuscular centric™ post P in place, the post P being used in preventing any increase in the vertical during setting of a mounting stone or in the fabrication of appliances on the articulator. While the invention has been described in connection with a specific embodiment thereof and in a specific use, various modifications thereof will occur to those skilled in the art without departing from the spirit and scope of the invention as set forth in the appended claims. The terms and expressions which have been employed in this specification are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions to exclude any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed.

1a

The cultivar `Cream Reagan` as described and illustrated herein is related to the following cultivars: `Dark Red Reagan` (U.S. Plant Pat. No. 9,929); `Sunny Reagan` (U.S. Plant Pat. No. 9,928); `Reagan` (U.S. Plant Pat. No. 8,642); `Salmon Reagan` (U.S. Plant Pat. No. 8,869); `Sulfur Reagan` (U.S. Plant Pat. No. 8,786); `Dark Reagan` (U.S. Plant Pat. No. 8,966); `Orange Reagan` (U.S. Plant Pat. No. 8,769); `Bronze Reagan` (U.S. Plant Pat. No. 8,865); `White Reagan` (U.S. Plant Pat. No. 8,784); `Coral Reagan` (U.S. Plant Pat. No. 8,974); `Yellow Reagan` (U.S. Plant Pat. No. 8,884); `Dark Splendid Reagan` (U.S. Plant patent application Ser. No. 08/646,224); and `Splendid Reagan` (U.S. Plant patent application Ser. No. 08/738,605). BACKGROUND OF THE INVENTION The present invention comprises a new and distinct cultivar of Chrysanthemum plant which is a natural occurring sport of a parent Chrysanthemum named `Reagan`. Parent Chrysanthemum `Reagan` is described in U.S. Plant Pat. No. 8,642. The new cultivar was discovered as a whole plant mutation in 1990 in a greenhouse in Holland. The invention has been asexually reproduced by cuttings at the same location. The new cultivar has been found to retain all of its distinctive characteristics through successive asexual propagations. SUMMARY OF THE INVENTION The present invention is a new and distinct variety of Chrysanthemum of a small to medium sized bloom and pale yellow color. BRIEF DESCRIPTION OF THE DRAWINGS The present invention of a new and distinct variety of Chrysanthemum is shown in the accompanying drawings, the color being as nearly true as possible with color photographs of this type. FIG. 1 shows the full bloom of the new cultivar. FIG. 2 shows the various stages of bloom of the new cultivar. FIG. 3 shows foliage and petiole of the new cultivar. DESCRIPTION OF THE INVENTION This new variety of Chrysanthemum is of the botanical classification Chrysanthemum morifolium. When grown in the vicinity of Ter Aar, Holland, it has a response time of approximately 71/2 weeks. This new variety produces small to medium sized pale yellow blooms with a yellow-green center having a 4 week performance (i.e., vase life of 24-28 days). This new variety of Chrysanthemum has been found to retain its distinctive characteristics throughout successive propagations and may be planted under greenhouse conditions in Holland between weeks 50 and 35. The following is a description of the plant and characteristics (color designations are from R.H.S. Color Chart) that distinguish it from related known varieties and its antecedents. The color designations are taken from the plant itself. Accordingly, any discrepancies between the color designations and the colors depicted in the photographs are due to photographic tolerances. ______________________________________Detailed Botanical Description and Comparative Data______________________________________CULTIVAR Cream Reagan Sunny Reagan______________________________________BudSize Medium Medium cross section cross section ±1.0 cm ±1.0 cm height ±0.7 cm height ±0.7 cmForm Round and flat Round and flatOutside Color Near Yellow 8A Between Yellow 7A/Yellow 9ABloomSize Small to Medium MediumFully Expanded 6-61/2 cm 61/2-7 cmBorne Upper portion Upper portion, single flower per single flower per peduncle lower peduncle, lower portion plural flo- portion plural wers per peduncle flowers per pe- dunclePeduncle Lengths Near the top ±14 Near the top ±14 cm, near the cm, near the middle ±24 cm middle ±24 cm, near the bottom near the bottom ±28 cm ±28 cmPeduncle Lateral Medium mediumShoot, AttachmentPeduncle Lateral Medium mediumShoot, AngleForm Single (Daisy) Single (Daisy)Performance Very good 24-28 Very good 24-28 days (18-20° C.) days (18-20° C.)ColorCenter of Flower:Immature Yellow-Green Yellow-Green 143B 151CMature Yellow-Green Yellow-Green 154A 154ABase of Petals Nearest Yellow 4C Yellow 5A dee- pening slightly to Yellow 6A in the basal halfOuter Petals Nearest Yellow 4C Yellow 5A dee- pening slightly to Yellow 6A in the basal halfInside of Petals Nearest Yellow 4C Yellow 5A dee- pening slightly to Yellow 6A in the basal halfReverse of Petals Nearest Yellow 4C Yellow 6ATonality from A pale yellow A yellow daisyDistance daisy with a fresh with a fresh looking center ha- looking center ving a little or no having a little or pollen no pollenDiscoloration None Some to Yellow 5BPollen Yellow-Orange Yellow-Orange 14A 14APetalsTexture Upperside smooth, Upperside underside smooth smooth, undersi- de smoothNumber 24-30 (two rows) 24-30 (two rows)Cross-section Convex (no keels) convex, two keelsArrangement Imbricated ImbricatedPersistence Good. Petals keep Good. Petals straight or reflex keep straight or somewhat at the reflex somewhat edge at the end of at the edge at the blooming. end of blooming.Fragrance Typical Chrysan- Typical Chrysan- themum themumDisc Diameter Medium to large Medium to large (1.5-2.0 cm) (1.5-2.0 cm)ReproductiveOrgansStamen Yellow, thick, 3 Yellow, thick, mm in length 3 mm in lengthPollen Appears at late Appears at late stage of blooming stage of bloomingStyles Green, thick Green, thickStyle Length ±5 mm ±5 mmStigmas Yellow YellowStigma Width ±1 mm ±1 mmOvaries Enclosed in calyx Enclosed in calyxPlantForm Spray mum meant Spray mum meant for erect culture. for erect culture. Herbaceous. Herbaceous.Growth Medium to tall StrongHeight 100-125 cm 100-125 cmStem Color Yellow-Green Yellow-Green 143C 144AStem Strength Medium StrongStem Brittleness Absent AbsentStem Anthocyanin Absent Present, mainlyColoration at the baseInternodes 3-31/2 cm 3 cmFlowering Response 71/2 weeks 71/2 weeksFoliageColor Upperside green Upperside Green 137A. Underside 137A. Underside Green 137C. Green 137C.Size Length ±12 cm. Length ±12 cm. Width ±10 cm. Width ±9 cm.Quantity 22-28 22-28Shape Lobed, see Lobed photographTexture Upperside rough, Upperside rough, underside smooth, underside slightly hirsute smooth, slightly hirsuteRibs and Veins Ribs well develo- Ribs well deve- ped. Veins not so loped. Veins not developed. so developed.Edge Crenated CrenatedShape of Base of Round RoundSinus BetweenLateral LobesMargin of Sinus Converging ConvergingBetween LateralLobesShape of Base Cordate TruncateApex Mucronate MucronateGrowthDifference in ave- +5 cm +10 cmrage lengthResponse timeDifference in days +1/2 +11/2of average responseResponse to ALAR(g/100 l 300 450H.sub.2 O)Year of Discovery 1990 1991______________________________________CULTIVAR Yellow Reagan Coral Reagan______________________________________BudSize Medium Medium cross section cross section ±1.0 cm ±1.0 cm height ±0.7 cm height ±0.7 cmForm Round and flat Round and flatOutside Color Yellow 9C Greyed Purple 186ABloomSize Medium MediumFully Expanded 61/2-7 cm 61/2-7 cmBorne Upper portion Upper portion, single flower per single flower per peduncle, lower peduncle, lower portion plural portion plural flowers per pe- flowers per pe- duncle dunclePeduncle Lengths Near the top ±14 Near the top ±14 cm, near the cm, near the middle ±24 cm middle ±24 cm, near the bottom near the bottom ±28 cm ±28 cmPeduncle Lateral weak to medium weak to mediumShoot, AttachmentPeduncle Lateral small smallShoot, AngleForm Single (Daisy) Single (Daisy)Performance Very good 24-28 Very good 24-28 days (18-20° C.) days (18-20° C.)ColorCenter of Flower:Immature Yellow-Green Yellow-Green 151C 151CMature Yellow-Green Yellow-Green 154A 154ABase of Petals Yellow 5C Greyed-Red 179C but redderOuter Petals Yellow 5C Greyed Red 179C but redderInside of Petals Yellow 5C Greyed Red 179C but redderReverse of Petals Yellow 4C Greyed Yellow 162D tinged with Red Purple 71B between ribs and marginTonality from A yellow daisy A pale bronzeDistance with a fresh daisy with a looking center fresh looking having a little or center having a no pollen little or no pollenDiscoloration Some to yellow Some to yellow- 5B orange 23CPollen Yellow-Orange Yellow-Orange 14A 14APetalsTexture Upperside Upperside smooth, undersi- smooth, undersi- de smooth de smoothNumber 24-30 (two rows) 24-30 (two rows)Cross-section flat, two keels flat, two keelsArrangement Imbricated ImbricatedPersistence Good. Petals keep Good. Petals straight or reflex keep straight or somewhat at the reflex somewhat edge at the end of at the edge at the blooming. end of blooming.Fragrance Typical Chrysan- Typical Chrysan- themum themumDisc Diameter Medium Medium (1.5 cm) (1.5 cm)ReproductiveOrgansStamen Yellow, thick, 3 Yellow, thick, mm in length 3 mm in lengthPollen Appears at late Appears at late stage of blooming stage of bloomingStyles Green, thick Green, thickStyle Length ±5 mm ±5 mmStigmas Yellow YellowStigma Width ±1 mm ±1 mmOvaries Enclosed in calyx Enclosed in calyxPlantForm Spray mum meant Spray mum meant for erect culture. for erect culture. Herbaceous. Herbaceous.Growth Strong StrongHeight 100-125 cm 100-125 cmStem Color Yellow-Green Yellow-Green 146B 144AStem Strength Medium MediumStem Brittleness Absent AbsentStem Anthocyanin Absent PresentColorationInternodes 3 cm 3 cmFlowering Response 71/2 weeks 71/2 weeksFoliageColor Upperside green Upperside Green 137A. Underside 137A. Underside Green 137C. Green 137C.Size Length ±12 cm. Length ±12 cm. Width ±9 cm. Width ±9 cm.Quantity 22-28 22-28Shape Lobed LobedTexture Upperside rough, Upperside rough, underside smooth, underside slightly hirsute smooth, slightly hirsuteRibs and Veins Ribs well deve- Ribs well deve- loped. Veins not loped. Veins not so developed. so developed.Edge Crenated CrenatedShape of Base of Round RoundSinus BetweenLateral LobesMargin of Sinus Parallel ConvergingBetween LateralLobesShape of Base Asymmetric AsymmetricApex Mucronate CuspidateGrowthDifference in ave- 0 -5 cmrage lengthResponse timeDifference in days +1 +1of average responseResponse to ALAR(g/100 l 280 250H.sub.2 O)Year of Discovery 1990 1998______________________________________CULTIVAR Bronze Reagan Salmon Reagan______________________________________BudSize Medium Medium cross section cross section ±1.0 cm ±1.0 cm height ±0.7 cm height ±0.7 cmForm Round and flat Round and flatOutside Color Greyed Red Nearest to Yellow 179C 23DBloomSize Medium MediumFully Expanded 61/2-7 cm 61/2-7 cmBorne Upper portion, Upper portion, single flower per single flower per peduncle, lower peduncle, lower portion plural portion plural flowers per pe- flowers per pe- duncle dunclePeduncle Lengths Near the top ±14 Near the top ±14 cm, near the cm, near the middle ±24 cm middle ±24 cm, near the bottom near the bottom ±28 cm ±28 cmPeduncle Lateral weak mediumShoot, AttachmentPeduncle Lateral small mediumShoot, AngleForm Single (Daisy) Single (Daisy)Performance Very good 24-28 Very good 24-28 days (18-20° C.) days (18-20° C.)ColorCenter of Flower:Immature Yellow-Green Yellow-Green 151C 151CMature Yellow-Green Yellow-Green 154A 154ABase of Petals Yellow 8A with Nearest to orange an overlay of 29C Greyed Red 179BOuter Petals Yellow 8A with Nearest to orange an overlay of 29C Greyed Red 179BInside of Petals Yellow 8A Nearest to orange an overlay of 29C Greyed Red 179BReverse of Petals Yellow 8C tin- Nearest to orange ged along the 22D center with Greyed Red 179B in a tesse- lated patternTonality from A pale bronze A yellow-orangeDistance daisy with a to orange daisy fresh looking with a fresh look- center having a ing center having little or no pollen a little or no pollenDiscoloration None NonePollen Yellow-Orange Yellow-Orange 14A 14APetalsTexture Upperside Upperside smooth, undersi- smooth, undersi- de smooth de smoothNumber 24-30 (two rows) 24-30 (two rows)Cross-section flat, two keels flat, two keelsArrangement Imbricated ImbricatedPersistence Good. Petals keep Good. Petals straight or reflex keep straight or somewhat at the reflex somewhat edge at the end of at the edge at the blooming. end of blooming.Fragrance Typical Chrysan- Typical Chrysan- themum themumDisc Diameter Medium Medium (1.5 cm) (1.5 cm)ReproductiveOrgansStamen Yellow, thick, 3 Yellow, thick, mm in length 3 mm in lengthPollen Appears at late Appears at late stage of blooming stage of bloomingStyles Green, thick Green, thickStyle Length ±5 mm ±5 mmStigmas Yellow YellowStigma Width ±1 mm ±1 mmOvaries Enclosed in calyx Enclosed in calyxPlantForm Spray mum meant Spray mum meant for erect culture. for erect culture. Herbaceous. Herbaceous.Growth Strong StrongHeight 100-125 cm 100-125 cmStem Color Yellow-Green Yellow-Green 144A 144AStem Strength Medium MediumStem Brittleness Absent PresentStem Anthocyanin Present PresentColorationInternodes 3 cm 3 cmFlowering Response 71/2 weeks 71/2 weeksFoliageColor Upperside green Upperside Green 137A. Underside 137A. Underside Green 137C. Green 137C.Size Length ±12 cm. Length ±12 cm. Width ±9 cm. Width ±9 cm.Quantity 22-28 22-28Shape Lobed LobedTexture Upperside rough, Upperside rough, underside smooth, underside slightly hirsute smooth, slightly hirsuteRibs and Veins Ribs well deve- Ribs well deve- loped. Veins not loped. Veins not so developed. so developed.Edge Crenated CrenatedShape of Base of Round RoundSinus BetweenLateral LobesMargin of Sinus Converging ParallelBetween LateralLobesShape of Base Asymmetric AsymmetricApex Cuspidate CuspidateGrowthDifference in ave- 0 +10 cmrage lengthResponse timeDifference in days -1/2 0of average responseResponse to ALAR(g/100 l 250 450H.sub.2 O)Year of Discovery 1998 1997______________________________________CULTIVAR Sulfur Reagan Parent Cultivar Reagan______________________________________BudSize Medium Medium cross section cross section ±1.0 cm ±1.0 cm height ±0.7 cm height ±0.7 cmForm Round and flat Round and flatOutside Color Yellow 10C Greyed Purple 186D but palerBloomSize Medium MediumFully Expanded 7-71/2 cm 61/2-7 cmBorne Upper portion Upper portion, single flower per single flower per peduncle, lower peduncle, lower portion plural portion plural flowers per pe- flowers per pe- duncle dunclePeduncle Lengths Near the top ±14 Near the top ±14 cm, near the cm, near the middle ±24 cm middle ±24 cm, near the bottom near the bottom ±28 cm ±28 cmPeduncle Lateral weak to medium MediumShoot, AttachmentPeduncle Lateral small MediumShoot, AngleForm Single (Daisy) Single (Daisy)Performance Very good 24-28 Very good 24-28 days (18-20° C.) days (18-20° C.)ColorCenter of Flower:Immature Yellow-Green Yellow-Green 151C 151CMature Yellow-Green Yellow-Green 154A 154ABase of Petals Yellow 6D Purple 75BOuter Petals Yellow 6D Purple 75BInside of Petals Yellow 6D Purple 75BReverse of Petals Yellow 6D Red-Purple 69D but palerTonality from A yellow daisy A pale pink daisyDistance with a fresh look- with a fresh look- ing center having a ing center having little or no pollen a little or no pollenDiscoloration None Some to Red- Purple 69DPollen Yellow-Orange Yellow-Orange 14A 14APetalsTexture Upperside smooth, Upperside smooth, underside smooth underside smmothNumber 24-30 (two rows) 24-30 (two rows)Cross-section flat, two keels flat, two keelsArrangement Imbricated ImbricatedPersistence Good. Petals keep Good. Petals straight or reflex keep straight or somewhat at the reflex somewhat edge at the end of at the edge at the blooming. end of blooming.Fragrance Typical Chrysan- Typical Chrysan- themum themumDisc Diameter Medium Medium (1.5 cm) (1.5 cm)ReproductiveOrgansStamen Yellow, thick, 3 Yellow, thick, mm in length 3 mm in lengthPollen Appears at late Appears at late stage of blooming stage of bloomingStyles Green, thick Green, thickStyle Length ±5 mm ±5 mmStigmas Yellow YellowStigma Width ±1 mm ±1 mmOvaries Enclosed in calyx Enclosed in calyxPlantForm Spray mum meant Spray mum meant for erect culture. for erect culture. Herbaceous. Herbaceous.Growth Strong StrongHeight 100-125 cm 100-125 cmStem Color nearest Green Yellow-Green 143C 144AStem Strength Medium to strong MediumStem Brittleness Absent PresentStem Anthocyanin Absent AbsentColorationInternodes 3 cm 3 cmFlowering Response 71/2 weeks 71/2 weeksFoliageColor Upperside Green Upperside Green 137A. Underside 137A. Underside Green 137C. Green 137C.Size Length ±12 cm. Length ±12 cm. Width ±9 cm. Width ±9 cm.Quantity 22-28 22-28Shape Lobed LobedTexture Upperside rough, Upperside rough, underside smooth, underside slightly hirsute smooth, slightly hirsuteRibs and Veins Ribs well deve- Ribs well deve- loped. Veins not loped. Veins not so developed. so developed.Edge Crenated CrenatedShape of Base of Round RoundSinus BetweenLateral LobesMargin of Sinus Parallel ConvergingBetween LateralLobesShape of Base Asymmetric RoundedApex Mucronate CuspidateGrowthDifference in ave- +10 cm 0rage lengthResponse timeDifference in days -1 0of average responseResponse to ALAR(g/100 l 450 300H.sub.2 O)Year of Discovery 1990 1996______________________________________

1a

CROSS-REFERENCE TO RELATED APPLICATION The present application is a divisional of application Ser. No. 13/248,865 filed Sep. 29, 2011. BACKGROUND OF THE INVENTION The present invention is generally directed to farm implements and, more particularly, to a method and apparatus for remotely controlling the hydraulics of a tractor or other implement towing vehicle. Increasingly, farm implements have been designed to have frames that can be folded between field-working and transport positions. One such type of farm implement is a stack-fold planter, such as the 1230 Stackerbar planter from Case New Holland, LLC, Stack-fold planters generally consist of a center frame section and a pair of wing frame sections. In the field-working position, the wing frame sections are evenly aligned with the center frame section. In the transport position, however, the wing sections are lifted to a position directly above the center frame section, i.e., to a “stacked” position. In the stacked position, the width of the implement is generally that of the center frame section, thus making the implement better suited for transport along roads and between crops. Openers are mounted to the frame sections at equal intervals, with each of the wing sections typically carrying one-half the number of openers mounted to the center frame section. The openers are designed to a cut a furrow into a planting surface, deposit seed and/or fertilizer into the furrow, and then pack the furrow. In this regard, each opener will have a seed box that is manually loaded with seed and/or fertilizer. Since the size of the seed box determines how much particulate matter the box can retain, there is generally a desire to have larger seed boxes for each of the openers. Since the larger seed boxes can hold more material, fewer refilling stops are needed when planting a field. Larger seed boxes, however, have drawbacks. The additional material that can be carried by larger seed boxes adds to the overall weight of the openers, including those mounted to the wing sections. This additional weight can stress the lifting/lowering system that stacks the wing sections, or require a more robust system, which can add to the overall size, mass, complexity, and cost of the implement. Larger spacing between seed trenches lower per acre crop yields. Further, it can be problematic and time consuming to individually fill each of the seed boxes, whether using bags or a conveyor system. Accordingly, bulk fill systems have been designed for stack-fold planters that generally consist of one or more bulk fill tanks mounted to a frame or toolbar that can be coupled to the frame of the stack-fold planter. The frame for the bulk fill system is supported above the ground by a lift wheel assembly that is designed to raise the frame when the stack-fold planter is in transport. Oftentimes, an operator will also raise the bulk fill system frame at headland turns when the gull wings are also raised to provide additional implement stability. Raising the gull wings and the frame for the bulk fill hopper(s) at headland turns poses one of the challenges that is faced by an operator when making a headland turn onto a new swath. More particularly, as the operator of a planter arrives at the headland of a field, the operator has to perform numerous tasks to reposition the planter in the next swath. Many of these tasks require the operator to attempt simultaneous control of three or more operations. For stack-fold planters equipped with lift assist wheels and/or gull wings, the operator needs to) retract the gull wings to prevent the wings from drooping when lifted from the ground, elevate the three-point hitch that connects the stack-fold planter to the towing vehicle, e.g., tractor, and extend the lift wheel assembly to raise the bulk fill system. The operator will also need to slow the tractor by shifting and/or reducing engine speed. By requiring the operator to perform these tasks substantially simultaneously, the operator can become mentally and physically fatigued, require an enhanced skill level to operate the stack-fold planter, increase the likelihood that the operator may make an error, or reduce the performance of the stack-fold planter at headland turns. SUMMARY OF THE INVENTION The present invention is directed to a method and apparatus for automating some of the tasks that heretofore required operator action at headland turns or similar events. For example, in one embodiment, the present invention automates operation of lift assist wheels and/or gull wings, such as those found on a stack-fold implement, based on the position of the tractor hitch to which the implement is coupled. Accordingly, an operator may control the position of the implement, such as at a headland turn, by raising and lowering the tractor hitch using a conventional remote control. The invention enables the planter to compare the tractor hitch position relative to an implement position and control operation of the implement accordingly without additional user inputs. In accordance with one aspect of the invention, a farm implement has a toolbar configured to be coupled to a towing vehicle and a bulk fill hopper mounted to a frame that is supported by a lift wheel assembly. The farm implement further has a connector for coupling the toolbar to a hitch of the towing vehicle. A first electrical input receives a hitch position signal from the towing vehicle and a second electrical input receives a frame position signal. The implement further has an electronic control unit (ECU) that receives the hitch position and the frame position signals and automatically activates the lift wheel assembly to maintain the frame in a level position as the vertical position of the connector changes. In accordance with another aspect of the invention, a farm implement having a frame supported by a lift wheel assembly comprises a connector for coupling the toolbar to the ISOBUS hitch of a towing vehicle, a first electrical input that receives a hitch position signal from the tractor, an electric over hydraulic valve that controls hydraulic fluid flow from the hydraulic system to the lift wheel assembly, and an electronic control unit (ECU). The ECU receives the hitch position signal and provides a command signal to the electric over hydraulic valve to control hydraulic fluid flow in the hydraulic system to raise the frame when the hitch is in a raised position. The present invention is also embodied in a method for automatically leveling a farm implement having a frame and being towed by a tractor that is coupled to the farm implement by a hitch. The method, which is preferably carried out automatically using various electronics, includes receiving a hitch position signal from the tractor and receiving a frame position signal from a sensor that detects a position of the frame. The method further includes the step of automatically raising or lowering the frame in response to changes in hitch position of the tractor. Other objects, features, aspects, and advantages of the invention will become apparent to those skilled in the art from the following detailed description and accompanying drawings. It should be understood, however, that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS Preferred exemplary embodiments of the invention are illustrated in the accompanying drawings in which like reference numerals represent like parts throughout. In the drawings: FIG. 1 is a pictorial view of an agricultural planting system comprised of a stack-fold planter coupled to a tractor; FIG. 2 is an isometric view of the stack-fold planter of FIG. 1 in a field-working (float) position; FIG. 3 is a rear elevation view of the stack-fold planter of FIG. 1 in a stacked, transport position; FIG. 4 is an isometric view of the central bulk fill system of FIG. 1 in a lowered, field working position; FIG. 5 is a schematic block diagram of a hydraulic control system according to one embodiment of the invention; and FIG. 6 is a schematic block diagram of a hydraulic control system according to another embodiment of the invention. DETAILED DESCRIPTION As will be made apparent from the following description, the present invention provides an apparatus that automatically adjusts the position of an implement in response to changes in the position of the hitch of a tractor towing the implement. For purposes of description, the invention will be described with respect to a stack-fold planter, such as that shown in FIGS. 1-4 , but it is understood that the invention is applicable with other types of implements. The invention, which can also be embodied in an automated method, is designed to reduce the number of user inputs that were heretofore required to command movements of the implement, such as at headland turns. Turning now to FIGS. 1-4 , a planting system 10 includes a stack-fold implement 12 , shown in a field working position, coupled to a prime mover 14 , e.g., tractor, in a known manner. For purposes of illustration, the stack-fold implement 12 is a row crop planter, which as shown in FIG. 2 , includes a frame 16 generally comprised of a center section 18 and wing sections 20 , 22 on opposite lateral sides of the center section. The center section 18 includes a tongue (not shown) that extends forwardly of the center section 18 for hitching the implement 12 to the prime mover 14 . As will be described more fully below, the implement 12 is coupled to a three-point hitch of the prime mover 14 . Gauge wheels 24 on the frame sections 18 , 20 , and 22 set the seeding or cutting depth for the implement. In the illustrated embodiment, sixteen openers 26 are mounted to the frame 16 at equally spaced intervals, but it is understood that more than or fewer than sixteen openers could be mounted to the frame 16 . As known in the art, the wing sections 20 , 22 may be raised to a transport position, as shown in FIG. 3 , in which the openers carried by the wing sections 20 , 22 are stacked over the center section 18 . As also known in the art, the openers 26 are designed to cut a furrow into the soil, deposit seed and/or fertilizer into the furrow, and then pack the furrow. Seed boxes or “mini-hoppers” 28 are optionally mounted to each of the openers 26 . The mini-hoppers 28 are preferably smaller than conventional mini-hoppers used with stack-fold crop row planters and thus hold less material than conventional seed boxes. The smaller mini-hoppers are flow-coupled to a central bulk fill assembly 30 that delivers material, such as seed and/or fertilizer, to the openers 26 and/or the mini-hoppers 28 . The central bulk fill assembly 30 preferably includes a pair of bulk fill hoppers 32 and 34 supported adjacently to one another on a frame 36 . The frame 36 is coupled to the center section 18 by a set of rearwardly extending frame members 38 , 40 , and 42 connected to a crossbar 44 . In a preferred embodiment, the frame members 38 , 40 , 42 are removably coupled to center frame section 18 which allows the bulk fill assembly 30 to be removed from the implement 12 or added as an after-market add-on to an existing stack-fold implement. The frame 36 is supported above the work surface (or transport surface) by a pair of wheels 46 , 48 that are each connected to the frame by a wheel lift assembly 50 , which in the illustrated embodiment includes a pair of parallel linkages 52 , 54 . Each linkage includes upper links 56 , 58 and lower link 60 , 62 , respectively. In addition to the links 56 - 62 , a pair of lift arms 64 , 66 are provided. Lift arm 64 is coupled to frame member 42 at a knuckle 68 to which parallel linkage 52 is also connected. In a similar manner, lift arm 66 is coupled to frame member 38 at a knuckle 70 to which parallel linkage 54 is also connected. As shown particularly in FIG. 4 , the frame 36 further includes a Y-beam 72 that is pivotally coupled to the center frame member 40 . As is customary for most central bulk fill assemblies, an air blower 74 is mounted beneath the bulk fill hoppers and is operable transfer particulate matter from the hoppers 32 , 34 to the individual mini-hoppers 28 or directly to the openers 26 in a forced air stream. As known in the art, central bulk fill hoppers, such as those described above, provide the convenience of a central fill location rather than having to fill the individual seed boxes. Also, the central fill hoppers have greater capacity than the seed boxes, which reduces the number of fill iterations that must be taken when planting. Simply mounting a central bulk fill assembly to a stack-fold planter, such as planter 12 , can create stability issues, especially when the stack-told planter is in the transport position. In this regard, the present invention provides a mechanism for raising the bulk fill assembly 30 when the stack-fold planter 10 is in the folded, transport position. Raising the bulk assembly 30 provides greater stability during transport as well provides increased clearance between the hulk fill assembly 30 and the roadway. A pair of hydraulic lift cylinders 76 and 78 are operable for lifting the frame 36 , and thus the bulk fill assembly 30 . Cylinder 76 is interconnected between forward knuckle 68 and a rearward knuckle 80 . As shown in FIG. 4 , the rearward knuckle 74 includes, or is coupled to, a mounting arm 82 that is coupled to axle 84 about which wheel 46 rotates. Cylinder 76 includes a ram 86 that is coupled to the rearward knuckle 80 whereas cylinder 76 is coupled to the forward knuckle 68 . In a similar fashion, cylinder 78 includes a ram 88 connected to a rearward knuckle 90 whereas the cylinder 78 is connected to the forward knuckle 70 . It will be appreciated that a mounting arm 92 is connected to, or formed with, the rearward knuckle 90 , and the mounting arm 92 is connected to an axle (not shown) about which wheel 48 rotates. As known in the art, central bulk fill hoppers, such as those described above, provide the convenience of a central fill location rather than having to fill the individual seed boxes. Also, the central fill hoppers have greater capacity than the seed boxes, which reduces the number of fill iterations that must be taken when planting. Simply mounting a central bulk fill assembly to a stack-fold planter, such as planter 12 , can create stability issues, especially when the stack-fold planter is in the transport position. In this regard, the present invention provides a mechanism for raising the bulk fill assembly 30 when the stack-fold planter 10 is in the folded, transport position. Raising the bulk assembly 30 provides greater stability during transport as well provides increased clearance between the bulk fill assembly 30 and the roadway. Turning now to FIG. 5 , the present invention provides a communications apparatus 94 for use with a prime mover equipped with ISO 11783 technology. The communications apparatus 94 includes datalink 96 that communicatively links an implement electronic control unit (ECU) 98 with electronics 100 of the prime mover 14 . The datalink 96 may be a wireless connection or, as shown in FIG. 5 , a wired communication consisting a connector 102 tethered by cable 104 to the electronics 100 and a receiver 106 tethered by cable 108 to ECU 98 . In a preferred embodiment, the connector 102 and the receiver 106 are ISO 11783 components that permit the transfer of data between the prime mover electronics 100 and the ECU 98 . Thus, it will be appreciated that the datalink 96 provides an ISOBUS connection between the prime mover 14 and the stack-fold implement 12 . The ISOBUS connection enables the transmission of various data between the stack-fold implement 12 and prime mover 14 . One type of data is hitch position information. The prime mover 14 has a hitch position sensor 110 that provides feedback to the electronics 100 of the prime mover 14 as to the vertical position of the coupling between the stack-fold implement 12 and the prime mover 14 . In one embodiment, this coupling is a three-point hitch. The prime mover electronics 100 provides a data signal to the ECU 98 via datalink 96 containing hitch position information. In accordance with one aspect of the invention, the ECU 98 adjusts the vertical position of the stack-fold implement 12 accordingly. More particularly, the stack-fold implement 12 has a frame position sensor 112 that measures the vertical position of the central bulk fill assembly 30 . In one preferred embodiment, the vertical position is determined from the angle between frame 36 and the wheel lift assembly 50 . It is contemplated that a number of sensors may be used to measure this angle including, but not limited to, rotary potentiometers, displacement sensors, optical sensors, strain gauges, pressure sensors, and the like. For example, in one embodiment, the frame position sensor 112 measures the displacement of either hydraulic lilt cylinder 76 or hydraulic lift cylinder 78 . The ECU 98 receives the frame position signal from the frame position sensor 112 and compares the frame position of the stack-fold implement 12 with the vertical position of the hitch, as provided in the hitch position signal. From this comparison, the ECU 98 raises or lowers the central bulk fill assembly 30 to level the central bulk fill assembly 30 in light of the changes in vertical position of the prime mover hitch. In one embodiment of the invention, the central bulk fill assembly 30 is raised or lowered by ECU 98 controlling operation of an electric over hydraulic valve 114 . The hydraulic valve 114 is interconnected between the hydraulics 115 of the prime mover 14 and the hydraulics of the stack-fold implement 12 , which include the pair of hydraulic lift cylinders 76 , 78 . Thus, the hydraulic valve 114 , upon receipt of a corresponding command signal from the ECU 98 , can increase or decrease the pressure in the pair of hydraulic lift cylinders 76 , 78 to raise or lower, respectively, the central bulk fill assembly 30 . It is highly desirable to increase the elevation of the central bulk fill assembly 30 when the hitch is raised and, conversely, lower the elevation when the hitch is lowered. In a further embodiment of the invention, also shown schematically in FIG. 5 , the wing sections 20 , 22 are moved automatically based on the vertical position of the three-point hitch. As known in the art, the hydraulic components, including lift actuators 116 , 118 are used to raise and lower the left wing section 22 (“left side gull wing”) and the right wing section 20 (“right side gull wing”), respectively. In this further embodiment, the ECU 98 also provides command signals to the left and right lift actuators, which can be of conventional design. In a preferred embodiment, the lift actuators are hydraulic cylinders whose operation is controlled by a valve, such as hydraulic valve 114 . As such, the ECU 98 provides control commands to the hydraulic valve 114 which in turn controls operation of the lift actuators preferably in synchrony with the wheel lift assembly 50 . It will be appreciated that the wing sections are movable between a field working position, such as illustrated in FIG. 2 and a retracted or raised position, such as illustrated in FIG. 3 . In the field working position, the wing sections (as well as the center section) are free to float so to respond to changes in surface contours. In this regard, the ECU 98 commands the electric over hydraulic valve 114 to control hydraulic fluid flow in the hydraulic system to move the wing sections to the float position when the hitch is in a fully lowered position. It will also be appreciated that in the embodiment illustrated in FIG. 5 , the operator of the tractor, i.e., towing vehicle, using conventional hydraulic remotes, pressurizes the tractor's hydraulic system to which the hydraulics of the implement are flow-coupled and thus also pressurized. As such, the operator must manually operate the hydraulic remotes to supply the hydraulic power needed to operate the lift actuators for the gull wings and the central bulk fill assembly. In contrast, and referring now to FIG. 6 , a communications apparatus 120 according to an alternate embodiment of the invention controls operation of the hydraulic remotes automatically, i.e., uses the tractor hydraulics 122 to directly control operation of the wheel lift assembly 50 and the lift actuators 116 , 118 rather than control an electronic-over-hydraulic valve 114 . More particularly, the hitch position sensor 110 provides hitch position data to the implement ECU 98 across ISOBUS connection 96 . The implement ECU 98 uses the hitch position information together with frame position data read from the frame position sensor 112 and provides control commands to the hydraulic remote(s) 124 , which are connected to the tractor hydraulics 122 in a known manner. The tractor hydraulics are flow-coupled to the actuators of the wheel lift assembly 50 and the lift actuators 116 , 118 . It is understood that the actuators could be independently flow coupled to the tractor hydraulics, but preferably, a single supply conduit 126 and return conduit 128 that are coupled to a manifold 130 or similar distribution device to which the actuators for the wheel assembly and the lift actuators are flow coupled in a conventional manner. It will thus be appreciated that in the embodiment illustrated in FIG. 6 , the implement controls the hydraulics of the tractor based on commands transmitted to the tractor via the ISOBUS connection. It will be appreciated that in one embodiment of the invention, the position of the tractor hitch is used to adjust the vertical position of the implement frame. It is understood however that in another embodiment, the vertical position of the implement frame could be monitored to cause automatic adjustment of the tractor hitch. Many changes and modifications could be made to the invention without departing from the spirit thereof. The scope of these changes will become apparent from the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to machines for cracking multiple nuts. More particularly, it cracks nuts by rolling them between two surfaces which move relative to one another and become closer together, increasing the pressure on the nuts as the nuts are pulled downward by gravity into a smaller cracking zone. 2. Related Art Power, U.S. Pat. No. 1,194,318, discloses a conical hopper, a conical rotor mounted within the hopper, means for operating the rotor, there being a downwardly decreasing inter-space between the rotor and the hopper, the hopper being provided with downwardly ranging channels formed in its inner walls, and the rotor being provided with spirally produced channels in its periphery, said channels in the hopper walls being angular in formation and separated by edge portions to which the material is presented upon the rotation of the rotor, and the rotor being provided in the channels with spaced pins projecting beyond the periphery of the rotor. Spitz, U.S. Pat. No. 1,274,803, discloses a cone-shaped hopper or shell with vertically-disposed ribs on its upper portion and teeth on its bottom portion, and an upright conical member with spiral ribs on its upper portion and teeth on its lower member, the teeth of the hopper and conical member having abrupt faces facing in opposite directions. Dragon, U.S. Pat. No. 2,129,679, discloses two conical members concentrically mounted one within the other so as to provide a downwardly diminishing substantially annular and conical space or chamber. Kasser, U.S. Pat. No. 2,302,227, discloses a process of cracking and shelling nuts which consists in rolling the nuts between opposite compressible surfaces so that the nuts are partly embedded in said surfaces, and forcing the rolled nuts at intervals on said surfaces over rigid cracking surfaces. SUMMARY OF THE INVENTION The present invention is a nutcracker comprising a conical member with a textured exterior surface inside a vertical cylinder with a textured interior surface. Nuts are placed in the space between the conical member and the vertical cylinder. As the conical member rotates within the vertical cylinder, gravity forces the nuts to roll downward into a cracking zone of increasingly reduced space, until the pressure between the conical member and the vertical cylinder causes the shells of the nuts to crack. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings illustrate several aspects of embodiments of the present invention. The drawings are for the purpose only of illustrating preferred modes of the invention, and are not to be construed as limiting the invention. FIG. 1 is a perspective view of the preferred embodiment of the present invention. FIG. 2 is another perspective view of the preferred embodiment shown in FIG. 1 . FIG. 3 is an exploded view of the preferred embodiment shown in FIGS. 1-2 . FIG. 4 is a front view of the preferred embodiment shown in FIGS. 1-3 . FIG. 5 is a bottom view of the preferred embodiment shown in FIGS. 1-4 . FIG. 6 is a top view of the preferred embodiment shown in FIGS. 1-5 . FIG. 7 is a rear view of the preferred embodiment shown in FIGS. 1-6 . FIG. 8 is a side view of the preferred embodiment shown in FIGS. 1-7 . FIG. 9 is a cross-sectional view of the preferred embodiment shown in FIGS. 1-8 taken from the side. FIG. 10 shows the conical member and rod of the preferred embodiment shown in FIGS. 1-9 . FIG. 11 shows the vertical cylinder, handles, and chute of the preferred embodiment shown in FIGS. 1-9 . DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred embodiment of the present invention is a nutcracker 10 which cracks the shells of nuts 2 by utilizing gravity to roll the nuts 2 downward into an increasingly narrow cracking zone 15 between a vertical cylinder 40 and a conical member 20 , as shown in FIG. 9 . A description of the preferred embodiment of the invention follows. The vertical cylinder 40 is the structural core of the nutcracker 10 . An open cylindrical shape, with open circles at each end and walls extending perpendicularly to the planes of the circles, is preferred because of its ease of manufacture. The vertical cylinder 40 is preferably formed from a rectangular sheet of metal formed into a right, circular cylinder, and welded together at the ends that come together, and preferably has a diameter of eight inches. Tread plate is preferred for the sheet of metal because it is readily available and inexpensive in the welding industry, and easy to form into the desired cylindrical shape. Its elongated protrusions 41 that extend no more than one-eighth of an inch from the surrounding plate surface and are at right angles to each other “woven” into a pattern at regular intervals as shown in FIGS. 1 , 3 , 9 , 10 , and 11 , allow the vertical cylinder to grip the nuts 2 to be cracked. The vertical cylinder 40 will preferably be formed with the treads facing inward, forming a textured interior surface 42 of the vertical cylinder. It is envisioned that tread plate with textures other than that shown, or rigidized metal or dimpled metal could be used as alternatives to the illustrated tread plate. The sheet of metal may be made of any kind of steel; however, stainless steel is preferred because it is the most sanitary material and easily washed. Aluminum, on the other hand, would wear down after repeated use and is therefore not desired. The vertical cylinder 40 preferably has handles 45 welded onto each side of the vertical cylinder 40 , which allow the nutcracker 10 to be carried and controlled once the nutcracker 10 is placed on the work surface. Welded onto the bottom of the vertical cylinder 40 will preferably be a bottom plate 56 , which prevents the vertical cylinder 40 from digging into the work surface. Four eight-pound manual release suction cups 80 , each two inches in diameter, are preferably bolted onto the bottom plate 56 , to prevent the nutcracker 10 from moving once it has been placed on the work surface; push-button suction cups could also be used. However, the nutcracker 10 could also be clamped onto the work surface, or even bolted onto the work surface. A first cross-arm bearing support 50 will preferably be attached at or near the top or the vertical cylinder 40 ; it is envisioned that the first cross-arm bearing support 50 could either be welded onto the vertical cylinder 40 directly, or fastened onto landings 44 which are welded onto the vertical cylinder 40 . The first cross-arm bearing support will preferably have a one-inch first bearing 51 attached to it which is configured to receive a rod 28 and allow the rod 28 to spin in the center of the vertical cylinder 40 . The first cross-arm bearing support 50 will preferably also have smaller holes which are configured to receive bolts for the purpose of attaching a hopper 60 to the vertical cylinder 40 . The hopper 60 is preferably an inverted partial cone, and serves as a funnel to allow more nuts 2 to be placed into the nutcracker 10 . The hopper 60 is manufactured as a separate piece from the vertical cylinder 40 . The hopper 60 is preferably made of sixteen-gauge sheet metal. The hopper 60 preferably has a horizontal plate 62 with small holes adapted to receive bolts, as well as a pair of slanted plates 64 with apertures adapted to receive bolts, all three plates being welded onto the hopper 60 . Means other than bolts to fasten the hopper 60 to the vertical cylinder 40 are envisioned. The slanted plates 64 are slanted to allow the nuts 2 to fall down into the vertical cylinder 40 . The configuration of horizontal plate 62 and slanted plates 64 have the purposes of securing the hopper 60 to the vertical cylinder 40 , and preventing hands from going into the vertical cylinder 40 and becoming injured. When the hopper 60 is placed onto the vertical cylinder 40 , the hopper 60 and vertical cylinder 40 preferably form an angle of 161 degrees. As shown in FIG. 9 , a first plate 54 is preferably attached to the entire interior perimeter of the vertical cylinder 40 . The first plate 54 preferably is made of sheet metal and has a smooth top surface, has a hole in its center that is adapted to allow a rod 28 to pass through and spin, and is slanted from the horizontal to allow shelled nuts 2 (comprising nut meat 2 ′ and shells 2 ″) to slide down along the first plate 54 and out of the vertical cylinder 40 through an opening 55 in the vertical cylinder 40 , preferably exiting the vertical cylinder 40 along a spout 46 . The spout 46 is preferably made from the same piece of sheet metal as the first plate 54 , and preferably has a bottom portion 48 which is parallel to the first plate 54 , and two side portions 49 which serve to guide the nuts 2 in a uniform direction as they exit the nutcracker 10 . A second plate 52 is preferably attached to the vertical cylinder 40 and to the bottom of the first plate 54 , and has a one-inch second bearing 53 configured to receive a rod 28 and allow the rod 28 to spin. Below the second plate 52 is a bevel gear comprising a first bevel wheel 74 and a second bevel wheel 76 . The first bevel wheel 74 is keyed to hold the rod 28 in place, the rod 28 also being keyed at its bottom end. The second bevel wheel 76 meshes with the first bevel wheel 74 . The second bevel wheel 74 is attached to a shaft 72 and crank 70 , which allow the user to turn the rod 28 within the vertical cylinder 40 , causing the conical member 20 to rotate. However, it is envisioned that there are other ways to turn the rod 28 and conical member 20 , such as with a motor with two sprockets and a chain, or by using a rod 28 long enough to extend beyond the hopper 60 and connected to a crank to the top end of the rod 28 . The second essential element of the nutcracker 10 besides the vertical cylinder 40 is the conical member 20 . The conical member 20 is centered in the vertical cylinder 40 . The conical member 20 preferably has a broad end 26 with diameter of seven inches, a narrow end 24 with diameter of four-and-one-half inches, and a height of eight inches. The conical member 20 is preferably hollow. It is preferably made of the same material as the vertical cylinder, with the treads facing outward to form a textured exterior surface 22 . For manufacture of the conical member 20 , the tread plate is cut with two arcs of different radii centered upon the same point. A sheet of metal, preferably also tread plate, is also used to close the narrow end 24 of the conical member 20 and the broad end 26 of the conical member 20 . However, if tread plate is used to close the narrow end 24 and the broad end 26 , the treads will face inward so that the exterior portions of the narrow end 24 and broad end 26 are smooth. A single rod 28 preferably extends through and is welded into the center of the narrow end 24 and the broad end 26 . The rod 28 preferably has a diameter of one inch. However, two separate rods could also be used, with one extending from the narrow end 24 and the other extending from the broad end 26 , and still achieve the purposes of the invention. The angle 92 between the textured exterior surface 22 and the broad end 26 is preferably between 80 and 84 degrees, and most preferably 82 degrees. The area between the textured exterior surface 22 and the textured interior surface 42 forms a cracking zone 15 . The textured interior surface 42 is vertical in the cracking zone 15 , as the textured interior surface 42 is preferably vertical at all points. The textured interior surface 42 is continuous from the top of the vertical cylinder 40 though the cracking zone 15 to the bottom of the vertical cylinder 40 because the vertical cylinder 40 , of which the textured interior surface 42 is a part, is inexpensively made from a single rectangular piece of sheet metal, preferably tread plate, bent into a right cylinder and welded together. The textured exterior surface 22 is also continuous from the narrow end 24 of the conical member 20 through the cracking zone 15 to the broad end 26 of the conical member 20 because the textured exterior surface 22 is also made from a single piece of sheet metal, preferably tread plate. An angle 90 between the textured exterior surface 22 of the conical member 20 and the textured interior surface 42 of the vertical cylinder 40 causes the cracking zone 15 between the textured exterior surface 22 and textured interior surface 42 to decrease as the nuts 2 are pulled downward by gravity. As the conical member 20 spins within the vertical cylinder 40 , or alternatively, as the conical member 20 is alternately spun in one direction and then the other, gravity causes the nuts 2 to roll downward and the cracking zone 15 is decreased, resulting in increasing pressure applied to the nuts 2 as they are squeezed between the textured exterior surface 22 and textured interior surface 42 . If either the textured exterior surface 22 or the textured interior surface 42 were smooth, then the nuts 2 would slip and move upward, never breaking or cracking. This is why tread plate is used to grip the nuts—its elongated protrusions 41 which protrude no more than one-eighth of an inch and are at right angles to each other woven into a pattern at regular intervals, cause consistent gripping and cracking of the nuts because of the even distribution of pressure, but not tearing into the shells and creating small pieces which must be cleaned. If the angle 90 were too great, then the nuts 2 would also slip and move upward, never breaking or cracking. However, if the angle 90 were two small, then the nuts 2 would be crushed and broken repeatedly as the pressure was applied over a greater distance, causing them to break into many small pieces. The inventor has found that an angle 90 between six and ten degrees, and preferably eight degrees, and a minimum cracking zone width M between the bottom part of the textured exterior surface 22 and textured interior surface 42 of three-eighths of an inch to five-eighths of an inch, and preferably seven-sixteenths to one-half of an inch, allows the nutcracker 10 to crack any type of nuts 2 except peanuts. No adjustment of the nutcracker 10 is needed to crack different types of nuts 2 . When the nuts 2 are poured between the vertical cylinder 40 and the conical member 20 and the conical member is rotated, the nuts 2 move downward, the shells of the nuts crack, and the nuts break into halves and thirds, fall onto the first plate 54 , and slide out of the nutcracker 10 along the spout 46 , as shown in FIG. 9 . Walnuts begin cracking when they are about half-way down from the top of the conical member 20 , and are usually cracked by the time they are two inches down from this half-way point. It has been found that 216 pounds of walnuts per hour, or one bushel of walnuts every ten minutes, can be cracked by hand using the embodiment described herein. Although this invention has been described above with reference to particular means, materials and embodiments, it is to be understood that the invention is not limited to these disclosed particulars, but extends instead to all equivalents within the scope of the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION(S) [0001] This application is a continuation of application Ser. No. 10/357,669, filed Feb. 4, 2003; which is a continuation of application Ser. No. 09/669,358, filed Sep. 26, 2000 (herein incorporated by reference) now U.S. Pat. No. 6,559,158; which is a continuation-in-part of application Ser. No. 09/120,703, filed Jul. 22, 1998 (herein incorporated by reference) now U.S. Pat. No. 6,274,591; which is a continuation-in-part of application Ser. No. 08/962,742, filed Nov. 3, 1997, now U.S. Pat. No. 5,972,954 the disclosures of which are herein incorporated by reference. This application also claims priority of provisional Application No. 60/168,480, filed Dec. 1, 1999, also herein incorporated by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Partial funding of the work described herein was provided under M01 RR00055 awarded by the U.S. Public Health Service General Clinical Research Center, and the U.S. Government has certain rights in the invention. BACKGROUND OF THE INVENTION [0003] The present invention is directed to the treatment of certain side effects associated with the use of opioids as analgesics. In particular, the present invention is directed to treating opioid-induced inhibition of gastrointestinal motility and constipation in patients chronically administered opioids. [0004] Opioids are effective analgesics. However, their use is associated with a number of undesirable side effects, particularly when use is prolonged or chronic. Such side effects include pruritus, dysphoria, urinary retention, and inhibition of gastrointestinal motility. Opioids are widely used long-term to treat pain in advanced cancer patients, or patients in methadone maintenance treatment programs, for example. Opioid-induced changes in gastrointestinal motility are almost universal when these drugs are used long term, and there is no evidence of gastrointestinal compensation mechanisms. Constipation is the most common chronic side effect of opioid pain medications in patients with metastatic malignancy, and can be severe enough to limit opioid use or dose. Common treatments of bulking agents and laxatives have limited efficacy and may be associated with adverse side effects such as electrolyte imbalances. The significant negative impact on the quality of life of these patients has received insufficient attention in the past from the medical community in general, and from the oncology community in particular. [0005] One treatment that has been used for opioid side effects is the use of opioid antagonists which cross the blood-brain-barrier, or which are administered directly into the central nervous system. Opioid antagonists such as naltrexone and naloxone have been administered intramuscularly or orally to treat opioid induced side effects. Naltrexone and naloxone are highly lipid soluble and rapidly diffuse across biological membranes, including the blood-brain barrier. Therefore, although naltrexone, naloxone, nalmefene, and other opioid antagonists may reverse many opioid side effects, because they diffuse into the central nervous system they have a narrow therapeutic window before they are observed to reverse the desired analgesic effect of the opioid being used. Additionally, in methadone maintenance patients, these tertiary compounds may also induce opioid withdrawal symptoms. [0006] Many quaternary amine opioid antagonist derivatives do not reduce the analgesic effect of opioids. These quaternary amine opioid antagonist derivatives, which have a relatively higher polarity and reduced lipid solubility when compared to the tertiary forms of the drugs, were specifically developed to not traverse the blood-brain barrier or to traverse it at a greatly reduced rate. Methylnaltrexone (MNTX) is a quaternary ammonium opioid receptor antagonist that does not cross the blood-brain barrier in humans (see, e.g., U.S. Pat. No. 4,176,186, herein incorporated by reference). It offers the therapeutic potential to reverse undesired side effects of opioid pain medications mediated by peripherally located receptors (e.g., in the gastrointestinal tract) while sparing opioid effects mediated by receptors in the central nervous system, most importantly, analgesia. [0007] However, high levels of MNTX in the plasma can lead to undesirable side effects such as orthostatic hypotension. Furthermore, high doses of opioid derivatives such as the tertiary and quaternary derivatives discussed above can be expensive. [0008] It is therefore clear that there is a need to enhance palliative care in terminal cancer patients and others. It is also clear that a method for the prevention of opioid-induced and inhibition of gut motility constipation which does not counteract the analgesic effects of the opioid, or risk increased levels of pain is needed. Ideally, such a treatment has few side effects and is economical because administration of small amounts is effective. SUMMARY OF THE INVENTION [0009] The methods of the invention address the particular needs of patients undergoing long-term or chronic opioid administration. The quaternary derivatives used in this group of patients induce laxation and relieve the side effects and intestinal immobility caused by opioid use at surprisingly low doses, enhancing the patient's quality of life, maintaining analgesic efficacy, reducing health risks associated with opioid side effects, and reducing possible quaternary derivative side effects and costs. [0010] “Long-term” opioid use or administration is intended to mean periods over about one week, and “chronic” use would generally mean a longer period wherein the patient is receiving an oral dose between 30 and 100 mg/day of methadone (or a dose of another opioid which is a morphine equivalent dose of between 30 and 100 oral mg/day of methadone). [0011] The methods comprise administering a quaternary derivative of noroxymorphone parenteraly in an amount between 0.015 and 0.45 mg/kg per day. The invention also includes methods wherein the derivative is administered by injection or infusion and the amount is between 0.015 and 0.365 mg/kg, preferably at an amount less than 0.3 mg/kg, more preferably at an amount less than 0.2 mg/kg, more preferably at an amount less than 0.165 mg/kg, more preferably at an amount less than 0.15 mg/kg, more preferably at an amount less than 0.115 mg/kg, more preferably at an amount less than 0.095 mg/kg, more preferably at an amount less than 0.065 mg/kg, more preferably at an amount less than 0.05 mg/kg, more preferably at an amount less than 0.025 mg/kg, or more preferably at an amount less than 0.015 mg/kg. The invention also includes a method as above, wherein the induced laxation is immediate laxation. The invention also includes a method as above wherein the quaternary derivative of noroxymorphone in methylnaltrexone. DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1 is a flow diagram of participant screening, randomization and follow-up. [0013] [0013]FIG. 2 shows a relationship between effective methylnaltrexone dose and peak plasma concentration in chronic methadone subjects. Peak plasma concentration ([C]max) is expressed as a function of methylnaltrexone dose that induced laxation response on first day administration (▴) and second day administration (). Subject 13 failed to defecate at the maximum dose (0.365 mg/kg) on day one (x) but did respond to the same dose on day two (+). The r 2 value for the linear regression of concentration on effective dose is 0.77. [0014] [0014]FIG. 3 shows changes in individual oral-cecal transit time of chronic methadone subjects. (A) The transit time (ordinate) of 11 subjects in placebo group from baseline to after placebo injection (abscissa). (B) The transit time (ordinate) of 11 methadone subjects in methylnaltrexone (MNTX) group from baseline to after study drug administration (abscissa). The heavy line represents the mean. The average change in the methylnaltrexone group was significantly greater than the average change in the placebo group (P<(0.001). [0015] [0015]FIG. 4 shows changes in individual oral-cecal transit times (ordinate) of 12 chronic methadone subjects after placebo and three oral methylnaltrexone doses (4 subjects in each dose group). Filled squares represent mean values. [0016] [0016]FIG. 5 is a comparison of oral-cecal transit times of normal volunteers and methadone maintenance subjects showing the increased responsiveness of chronic opioid patients to MNTX. At doses ranging from 2.1 mg/kg to 6.4 mg/kg, normal subjects experienced about a 15-20% reduction in oral-cecal transit time, while at a dose of 3.0 mg/kg, methadone subjects experienced a greater than 35% reduction in oral-cecal transit time. DETAILED DESCRIPTION OF THE INVENTION [0017] The present invention is directed to methods for preventing and treating the inhibition of gastrointestinal motility, particularly constipation, that arises in the group of patients taking chronic or maintenance doses of opioids. These patients include late stage cancer patients, elderly patients with osteoarthritic changes, methadone maintenance patients, neuropathic pain and chronic back pain patients. It has been discovered that the group of patients chronically taking opioids is surprisingly responsive to doses of quaternary derivatives of noroxymorphone that were previously considered too low to be clinically efficacious. Treatment of these patients is important from a quality of life standpoint, as well as to reduce complications arising from chronic constipation, such as hemorrhoids, appetite suppression, mucosal breakdown, sepsis, colon cancer risk, and myocardial infarction. [0018] In the invention, a preferred quaternary derivative of noroxymorphone is methylnaltrexone. Preferred side effects to be treated include constipation and gastrointestinal motility inhibition, dysphoria, pruritus, and urinary retention. [0019] When used as a treatment for these opioid-induced side effects, methylnaltrexone (MNTX) or other quaternary derivatives of noroxymorphone (QDMN) provide prolonged relief of the side effects. Idiopathic constipation, i.e., that due to causes other than exogenous administration of opioids, may be mediated by opioid sensitive mechanisms. Endogenous opioid receptors have been identified in the gut and these receptors may modulate gut motility. Thus, administration of an opioid antagonist with peripheral action, such methylnaltrexone or other quaternary derivatives of noroxymorphone, would block the effects of endogenous opioids. [0020] Quaternary derivatives of noroxymorphone are described in full in Goldberg et al., U.S. Pat. No. 4,176,186 (herein incorporated by reference), and in general are represented by the formula: [0021] wherein R is allyl or a related radical such as chlorallyl, cyclopropyl-methyl or propargyl, and X is the anion of an acid, especially a chloride, bromide, iodide or methylsulfate anion. [0022] The presently preferred quaternary derivative of noroxyrnorphone is methylnaltrexone. Methylnaltrexone is a quaternary amine derivative of naltrexone. Methylnaltrexone has been found to have only 2 to 4% of the opiate antagonistic activity of naltrexone in vivo due to its inability to pass the blood-brain-barrier and bind to the opiate receptors in the central nervous system. [0023] Opioids are typically administered at a morphine equivalent dosage of. 0.005 to 0.15 mg/kg body weight for intrathecal administration; 0.05 to 1.0 mg/kg body weight for intravenous administration; 0.05 to 1.0 mg/kg body weight for intramuscular administration; 0.05 to 1.0 mg/kg body weight/hour for transmucosal or transdermal administration. By “morphine equivalent dosage” is meant representative doses of other opioids which equal one milligram of morphine, for example 10 mg meperidine, 1 mg methadone, and 80 μg fentanyl. [0024] In accordance with the present invention, methylnaltrexone is administered at a dosage of: 0.001 to 1.0 mg/kg body weight for intravenous administration; 0.001 to 1.0 mg/kg body weight for intramuscular administration; 0.001 to 1.0 mg/kg body weight for transmucosal administration and 0.1 to 40.0 mg/kg body weight for oral administration. [0025] The administration of the methylnaltrexone is preferably commenced prior to administration of the opioid to prevent opioid-induced side effects, including constipation. It is desirable to commence administration of methylnaltrexone about 5 minutes for parenteral MNTX administration and 20 minutes for enteral MNTX administration prior to administration of opioids in order to prevent these opioid-induced side effects, While the prevention of symptoms is preferred, in some patients, such as those chronically on opioids, prevention is not possible. However, methylnaltrexone administration may also be commenced after the administration of the opioid or after the onset of opioid induced symptoms as a treatment for those symptoms. [0026] Methylnaltrexone is rapidly absorbed after oral administration from the stomach and bowel. Initial plasma levels of the drug are seen within 5-10 minutes of the administration of non-enteric coated compound. Addition of an enteric coating which prevents gastric absorption is associated with lower plasma levels of the methylnaltrexone. [0027] For intravenous or intramuscular administration, methylnaltrexone (from, e.g., Mallinckrodt Pharmaceuticals, St. Louis, Mo.) is formulated with saline or other physiologically acceptable carriers; for transmucosal administration the methylnaltrexone is formulated with a sugar and cellulose mix or other pharmacologically acceptable carriers known in the art; and for oral administration, the methylnaltrexone is provided in granules which can be coated or left uncoated, and can be put in gelatin capsules. An enteric coating manufactured by Coating Place, Inc., Verona, Wis. can be made as follows. The drug was prepared by encapsulating MNTX powder with a Eudragit L100 and Myvacet 9-45 mixture. The final substance used in the study was the 45-80 mesh fraction which was 50% MNTX by weight. This was demonstrated to decrease release of the drug at gastric pH by 77% based on the methods of the USP/NF. These microencapsulated granules were then put into gelatin capsules for administration. Alternatively, methylnaltrexone is formulated with pharmacologically acceptable binders to make a tablet or capsule with or without an enteric coating. Methods for such formulations are well known to those skilled in the art (see e.g., Remington: The Science and Practice of Pharmacy, 19 th ed. (1995) Mack Publishing Company, Easton, Pa.; herein incorporated by reference). [0028] Any art-known transdermal application may be used, but transdermal administration is preferably via a patch applied to the skin with a membrane of sufficient permeability to allow diffusion of MNTX at a fixed rate in the range of 1.0 to 10.0 mg/hr. The rate of administration may be varied by varying the size of the membrane contact area and/or applying an electrical wiring potential to a drug reservoir. The patch preferably holds 25 mg to 1 gram of available drug in the reservoir plus additional drug as needed for the mechanics of the system. [0029] In the description above and below, methylnaltrexone is used as an example of a particularly effective QDNM. It is apparent that other QDNMs may be used as desired, and appropriate dosage can readily be determined empirically by those of skill in the art to account for e.g., variable affinity of the QDNM for opiate receptors, different formulations, etc. [0030] The following Examples are intended to illustrate aspects of the invention and are not to be construed as limitations upon it. EXAMPLE 1 Effects of Standard MNTX Dosage on Chronic Opioid Patients [0031] Subjects [0032] With approval from the Institutional Review Board at the University of Chicago, two male and two non-pregnant female adults participating in a methadone maintenance program were enrolled in this study. All four subjects were African Americans. Their mean age ±SD (range) was 45.3±8.6 (35-56) years. [0033] Subjects in this study met the following inclusion criteria: (1) They were currently enrolled in a methadone maintenance program for at least 1 month; (2) they experienced methadone-induced constipation, i.e. less than one bowel movement in the previous 3 days or less than three bowel movements in the previous week (O'Keefe et al., J Gerontol., 50:184-189 (1995); Parup et al., Scand. J Gastroenterol, 33:28-31 (1998)). Exclusion criteria were as follows: (1) History or current evidence of significant cardiovascular, respiratory, endocrine, renal, hepatic, hematological or psychiatric disease; (2) any laboratory findings indicating hepatic or renal impairment, or abnormal physical examination findings; (3) current use of other medications, or evidence of illicit drug use; (4) known hypersensitivity to lactose or lactulose; (5) participation in any investigational new drug study in the previous 30 days; (6) subject is breastfeeding. Subjects also agreed not to take any laxatives for 2 days before the beginning of the study and during the study. [0034] Protocol [0035] After obtaining written, informed consent, subjects were admitted to the Clinical Research Center at the University of Chicago Medical Center for up to 8 days. Methylnaltrexone dose of 0.45 mg/kg was chosen to start this trial because this dose was previously given in normal volunteers and prevented opioid-induced delay of the oral-cecal transit time without any side effects (Yuan et al., Clin. Pharmacol Ther., 59:469-475 (1996)). Drug administration was performed single blind to the subjects in this pilot study. Thus, methylnaltrexone dose could be adjusted based on subjects' clinical response during the study. [0036] All four subjects received test drug (normal saline or methylnaltrexone (N-methylnaltrexone bromide, prepared by Mallinckrodt Specialty Chemicals, St. Louis, Mo)) twice daily at 09:00 h and 21:00 h, except on the last day of the study in which they received test drug only at 09:00 h. All four subjects received placebo (normal saline) on Day 1. Thereafter, subjects received intravenous methylnaltrexone until the end of the study. [0037] On Day 2 at 09:00 hours (h), Subjects 1 and 2 were given 0.45 mg/kg intravenous methylnaltrexone over 1 min. Subject 2 experienced severe abdominal cramps after receiving the compound and was withdrawn from the study. Subject 1 did not experience abdominal cramps after the first dose of methylnaltrexone, but was given placebo in place of the compound at the regularly scheduled dosing times for Day 2 and Day 3 to maintain the single blind study while the reaction of Subject 2 was investigated. Beginning on Day 4, the study was resumed for Subject 1 using 0.45 mg/kg of methylnaltrexone, diluted with 50 ml normal saline and administered over 30 min. Infusion could be stopped at any time for complaints of abdominal pain. [0038] For Subjects 3 and 4, the study was shortened from 8 to 5 days, methylnaltrexone dosage was decreased, and a new, three-step dosing procedure was established. Methylnaltrexone 0.05 mg/kg, mixed in 30 ml normal saline (first syringe), was infused intravenously over 10 min. The subject was then observed 10 min for drug response. If there was no response, then methylnaltrexone 0.1 mg/kg (second syringe), mixed in 30 ml normal saline, was infused over 15 min. Subject was observed 15 min for drug response. If there was no response, then methylnaltrexone 0.3 mg/kg (third syringe), mixed in 30 ml normal saline, was infused over 15 min. [0039] Vital signs were obtained at 0, 5, 10, 30, 60, 90 and 120 min after each test drug administration. For oral-cecal transit time measurement, 10 g lactulose (Solvay Pharmaceuticals, Marietta, Ga.) was administered orally at 09:00 h of Day 1, Day 5 and Day 8 for Subject 1; of Day 1 for Subject 2 and of Day 1, Day 3 and Day 5 for Subjects 3 and 4. Illicit drug use was monitored by random urine drug screens. [0040] Blood and Urine Sampling and Analysis, Bowel Function Assessment [0041] After each test drug administration, seven blood samples (5 ml each) were obtained at time 0, 5, 30 min, and 1, 2, 4, 8 h, and three urine samples were collected at time 0, 2, and 4 h. Plasma and urine methylnaltrexone levels were determined by an HPLC technique with a detection limit of 2 ng/ml (Kim et al., 1989; Yuan et al., Clin. Pharmacol Ther., 59:469-475 (1996); both herein incorporated by reference). Subjects were asked to record frequency and consistency of stools during the study period. Subjects' bowel movements were witnessed and recorded by a research nurse. [0042] Oral-Cecal Transit Time Measurement [0043] The oral-cecal transit time was assessed by the pulmonary hydrogen (H 2 ) measurement technique, which measures pulmonary H 2 that is produced when unabsorbed lactulose is fermented by colonic bacteria and excreted in the breath. This H 2 production is reflected by a concomitant increase in breath H 2 excretion. The time between ingestion and the earliest detectable and sustained rise in pulmonary hydrogen excretion, i.e., a sudden rise to peak (>25 ppm), or an increase of at least 2 ppm above the baseline, maintained and increased in three consecutive samples, indicates that lactulose has reached the cecum and represents the oral-cecal transit time (see e.g., Yuan, et al., Clin. Pharmacol Ther., 59:469-475) (1996); Bond and Levitt, J. Lab Clin. Med, 85:546-555 (1975); Read, et al., Gut., 26:834-842 (1985) Bailisco, et al, Dig. Dis. Sci., 32:829-832 (1987)). Hydrogen breath tests were conducted every 15 min until oral-cecal transit time was determined. [0044] Evaluation of Central Opioid Withdrawal [0045] To evaluate possible opioid withdrawal with methylnaltrexone, subjects were asked to rate on a 5-point scale from 0 (not at all) to 4 (extremely) an objective checklist Withdrawal Scale (Fraser et al., J Pharmacol Exp. Ther, 133:371-387 (1961); Jasinski, Drug Addiction J., 197-258 (1977); both herein incorporated by reference). Items to be rated were: muscle cramps, flushing, painful joints, yawning, restless, watery eyes, runny nose, chills or gooseflesh, sick to stomach, sneezing, abdominal cramps, irritable, backache, tense and jittery, sweating, depressed/sad, sleepy, shaky (hands), hot or cold flashes, and bothered by noises. The ratings for individual items were summed for a total score for each scale. The total scores were compared before and after methylnaltrexone administration to see if there was a significant difference. [0046] Results [0047] All four subjects showed no response to placebo injection. Subjects 1 and 2, who received a methylnaltrexone dose of 0.45 mg/kg, showed immediate positive laxation during or immediately after intravenous drug infusion. During 7 days of methylnaltrexone administration, Subject 1 did not experience any significant side effects, and reported mild abdominal cramping after each injection. Subject 2, however, had severe abdominal cramping after a single dose of methylnaltrexone, but showed no signs of systemic withdrawal such as lacrimation, diaphoresis, mydriasis, or hallucinations. Subject 2 was released without receiving additional methylnaltrexone. [0048] Subjects 3 and 4 received intravenous methylnaltrexone (0.05-0.15 mg/kg) twice daily for 4 consecutive days. This 0.05-0.15 mg/kg dose range induced immediate laxation response in these two subjects, therefore, the third syringe injection (methylnaltrexone dose 0.3 mg/kg dose) was not administered during the study. No significant side effects were observed. Like Subject 1, both subjects described mild abdominal cramping, similar to a defecation sensation, without discomfort involved. [0049] The stool frequency of these subjects increased from 1-2 times per week before the study to approximately 1.5 stool per day during the treatment period (Table 1). For Subjects 1, 3, and 4, oral-cecal transit times were reduced from 150, 150 and 150 min (after placebo) to 90, 60 and 60 min (after methylnaltrexone, at the end of the study), respectively. The baseline transit time for Subject 2 was 180 min. Due to the discontinuation. of this subject, no other transit time was recorded after Day 1. [0050] Peak plasma methylnaltrexone levels for Subjects 1, 2, 3 and 4 were 1.65, 1.10, 0.25 and 0.53 μg/ml, respectively. TABLE 1 Intravenous methylnaltrexone reverses chronic-opioid induced gut motility and transit time changes in methadone subjects. Stool Intravenous frequency Central Oral methadone methylnaltrexone Laxation Before study Methylnaltrexone Abdominal opioid Subject (mg/day) (mg/kg) response (per week) (per day) cramping withdrawal #1 70 0.45, bid Immediate 1 1.5 Mild No #2 38 0.45 Immediate 2 1 Severe No #3 80 0.05-015, bid Immediate 2 1.3 Mild No #4 65 0.05-0.15, bid Immediate 1.5 2 Mild No [0051] Discussion [0052] In previous healthy volunteer studies, intravenous 0.45 mg/kg methylnaltrexone effectively prevented opioid-induced delay in oral-cecal transit time without affecting analgesia (Yuan et al., Clin. Pharmacol Ther., 59:469-475 (1996)). However, that study was performed in normal volunteers after acute single administration doses of opioid and methylnaltrexone. Thus, the dose relationship of agonist to antagonist remained unknown in opioid-tolerant individuals, such as subjects in methadone maintenance programs as well as advanced cancer patients with chronic opioid pain medications. [0053] When this study was designed, 0.45 mg/kg intravenous methylnaltrexone was chosen, the dose previously administered in normal volunteers that did not cause gastrointestinal symptoms (e.g. abdominal cramping) or laxation response. To achieve positive laxation while limiting the possibility of adverse effects, BID dosing was planned for 7 days. Due to the fact that the elimination half-life of intravenous methylnaltrexone is approximately 2 h (Yuan et al., Clin. Pharmacol Ther., 59:469-475 (1996); Foss et al., J Clin. Pharmacol, 37:25-30 (1997)), no drug accumulation was expected in this study. [0054] After intravenous injection, immediate bowel movements were observed in the first two subjects. While methylnaltrexone has been demonstrated to not reverse the analgesic effects of opioids (Yuan et al., Clin. Pharmacol Ther., 59:469-475 (1996)), the potential effects of the compound in a population of chronic opioid users was unknown. Gastrointestinal symptoms are one of the hallmarks of gut withdrawal, and the persistent severe cramping in Subject 2, which required treatment, prompted a modification of the protocol. It is important to note, however, that none of the other primary indicators of opioid withdrawal were noted in this or any of the other subjects. For the next two subjects, the drug dose was reduced and the study duration shortened. While no effects were observed after placebo, positive laxation and significant reduction of the gut transit time were observed after a lower intravenous dose of methylnaltrexone in these two chronic methadone subjects. [0055] Peak plasma levels of methylnaltrexone in all subjects were determined and were comparable to those seen in volunteers given similar doses (Yuan et al., Clin. Pharmacol Ther., 59:469-475 (1996); Foss et al., J Clin. Pharmacol, 37:25-30 (1997)). Subject 1, who had laxation but no other symptoms actually had higher peak plasma levels than Subject 2 (with the severe abdominal cramping), suggesting a difference in Subject 2's pharmacological response rather than a difference in pharmacokinetics. [0056] The three subjects who completed the study reported mild abdominal cramping during intravenous methylnaltrexone infusion. The mild cramping appears to be a physiological desire to move the bowels, because the cramping disappeared after their bowel movement. Since the half-life of methylnaltrexone is approximately 2 h, one would expect that cramping caused by hyperactivity of the gut to be more prolonged. This indicates that methylnaltrexone and similar QDNMs are safe and ideal candidates to resolve opioid induced constipation without stimulant/laxative type side effects. EXAMPLE 2 Effects of Variable MNTX Dosage on Chronic Opioid Patients [0057] This Example was a double-blind, randomized, placebo-controlled trial, evaluating the effects of methylnaltrexone in treating chronic opioid-induced constipation. We conducted this trial using subjects in a methadone maintenance program, in which approximately 60% of the chronic methadone users have constipation. These subjects served as a proxy group for advanced cancer patients to evaluate the efficacy of methylnaltrexone on chronic opioid-induced constipation. [0058] With approval from the Institutional Review Board, 9 male and 13 non-pregnant, non-breastfeeding female adults were enrolled (FIG. 1). Their mean age±S.D. (range) was 43.2±5.5 (25-52) years. Subjects met the following inclusion criteria: (1) Enrollment in a methadone maintenance program for >1 month; (2) Methadone-induced constipation, i.e., 0-1 bowel movement in the previous three days, or 0-2 bowel movements in the previous week; (3) No laxative use two days before the study nor during the study. Exclusion criteria were as in the previous Example. [0059] Protocol [0060] An investigator explained the study procedures and obtained written, informed consent from 22 paid subjects. These subjects, who continued to receive their usual dose of methadone during the study, were admitted to the Clinical Research (Center at the University of Chicago Medical Center for two days. An intravenous catheter was placed in each arm, one for test drug administration (placebo or methylnaltrexone [N-methylnaltrexone bromide], prepared by Mallinckrodt Specialty Chemicals, St. Louis, Mo.), and the other for blood drawing. [0061] On Day 1, at 9 AM, after a restricted supper of no fiber the night before (required for the oral-cecal transit time measurement, see below) and overnight fasting, subjects were instructed to ingest 10 g lactulose (Solvay Pharmaceuticals, Marietta, Ga.) in 1.00 ml tap water. Subjects were also given placebo (normal saline) in four syringes (35 ml each) for intravenous injection (single-blinded to the subject). [0062] On Day 1, at 5 PM, subjects were given placebo or methylnaltrexone up to 0.365 mg/kg over four syringes. Each syringe contained placebo or methylnaltrexone in 35 ml of normal saline, and was administered intravenously over nine minutes. For the methylnaltrexone group, syringes 1, 2, 3 and 4 contained 0.015, 0.05, 0.1 and 0.2 mg/kg study drug, respectively. The interval between administration of each syringe in both groups was one minute. The continued administration of each syringe depended on the absence of a clinical laxation response (i.e., elimination of any stool) and/or potential side effects. Immediate laxation was defined as defecation either during or within one minute after cessation of the infusion. The injection was discontinued if the subject had a bowel movement. [0063] After a non-fiber supper the night before and overnight fasting, subjects on Day 2 at 9 AM, were again given test drug intravenously. Subjects were also given 10 g lactulose at this time. Day 2 studies were done to test the constancy of effect and to measure the oral-cecal transit time; this study did not have a crossover design. [0064] Injection assignment was prepared using a table of random numbers from which sealed envelopes were prepared and opened sequentially as subjects were enrolled in the study. No stratification or blocking factors were used, except to insure that equal numbers of subjects were assigned to each treatment group after enrollment of the last (22 nd ) subject. Randomization and test drug preparation were done by a biostatistician and a physician, respectively, who did not participate in data acquisition and evaluation. [0065] Vital signs were obtained at 0, 5, 10, 30, 60, 90 and 120 min after each test drug administration. Illicit drug use was monitored by random urine drug screens. [0066] Blood and Urine Sampling and Analysis [0067] Blood and urine sampling and analysis were performed as in Example 1. [0068] Bowel function assessment [0069] Subjects were asked to record frequency and consistency of stools during the study period. Subjects' bowel movements were confirmed and recorded by a research nurse blinded to the group assignment. At the end of the study, the subjective opinion of each participant was gathered in order to rate subjects' satisfaction in respect to bowel movement. [0070] Oral-Cecal Transit Time Measurement [0071] The oral-cecal transit time was assessed as in Example 1. [0072] Evaluation of Central Opioid Withdrawal [0073] To evaluate possible opioid withdrawal with methylnaltrexone, before and 10 min after the completion of test drug administration, subjects were asked to complete an objective checklist of withdrawal symptoms modified from Fraser et al. ( J. Pharmacol Exp. Ther., 133:371-387 (1961)) and Jasinski ( Drug Addiction J., 197-258 (1977)). Items rated (none, mild, moderate, severe) were yawning, lacrimation (excessive tearing) rhinorrhea (nasal discharge), perspiration, tremor, piloerection (goosebumps), and restlessness. The ratings for individual items were translated to a 0-3 scale and summed to give a total symptom score. The total scores before and after test drug administrations were compared between the groups. Potential opioid withdrawal symptoms were also monitored by an investigator throughout the study. [0074] Statistical analysis [0075] Laxation responses were compared between groups using Fisher's exact test. The Mann-Whitney U test was used to compare the change from baseline in oral-cecal transit time between the two groups and to evaluate statistical differences between genders in oral-cecal transit times with P<0.05 considered statistically significant. Changes in opioid withdrawal symptoms were analyzed similarly. [0076] Results [0077] The mean stool frequency per week of the 22 subjects before the study was 1.5±0.7. All 22 subjects showed no response to placebo in the morning of Day 1. Eleven subjects were randomized to each treatment group. Those randomized to placebo received all four syringes in Day 1 afternoon and Day 2 morning sessions. As shown in Table 2, none of them showed any laxation response after placebo, and no abdominal cramping was reported. At the end of the trial, seven of them were disappointed in respect to bowel movement satisfaction. There were no significant bowel movement frequency changes before and during the study. There were no opioid withdrawal and no significant side effects in these subjects. [0078] Ten subjects in the methylnaltrexone group had immediate laxation response in the Day 1 afternoon session, and all 11 subjects had immediate laxation in the Day 2 morning session (Fisher's exact P value<0.0001 when compared with placebo group response for both Days 1 and 2). The stool of most subjects (over 90%) was soft to loose and in large quantity. The methylnaltrexone dose received was 0.09±0.10 (0.01-0.37) mg/kg and 0.10±0.10 (0.01-0.37) mg/kg for Day 1 and Day 2, respectively. FIG. 2 shows the relationship between effective methylnaltrexone dose and peak plasma concentration. [0079] During and immediately after each study drug injection, all subjects reported mild to moderate abdominal cramping, which they described as being similar to a defecation sensation, without discomfort involved. There was no opioid withdrawal symptoms observed in any of these subjects during the study. No significant side effects were reported by the subjects. Subject 13 reported mild light-headedness which resolved spontaneously. No subject demonstrated any clinically significant change in blood pressure or heart rate from baseline with either the placebo or study drug infusions. Subjects did not have additional bowel movements after drug-induced-immediate laxation, except Subject 15 who reported mild diarrhea. At the end of the study, all 11 subjects were satisfied with their bowel movement activity (Table 2). TABLE 2 Methylnaltrexone (MNTX) reverses chronic opioid constipation in methadone subject. Oral Day One Day Two Bowel Subject Methadone Test Drug Laxation Test Drug Laxation movement Number (mg/day) (mg/kg) Response (mg/kg) Response Satisfaction 1 50 Placebo No Placebo No Disappointed 2 65 Placebo No Placebo No Disappointed 4 85 Placebo No Placebo No Disappointed 5 61 Placebo No Placebo No Disappointed 8 42 Placebo No Placebo No Disappointed 11 89 Placebo No Placebo No (not available) 14 85 Placebo No Placebo No Disappointed 16 50 Placebo No Placebo No Satisfied 18 50 Placebo No Placebo No Disappointed 19 75 Placebo No Placebo No (not available) 22 50 Placebo No Placebo No Somewhat satisfied 3 55 MNTX 0.015 Immediate MNTX 0.015 Immediate Very satisfied 6 59 MNTX 0.065 Immediate MNTX 0.065 Immediate Very satisfied 7 68 MNTX 0.165 Immediate MNTX 0.165 Immediate Very satisfied 9 65 MNTX 0.065 Immediate MNTX 0.115 Immediate Satisfied 10 30 MNTX 0.065 Immediate MNTX 0.065 Immediate Very satisfied 12 45 MNTX 0.075 Immediate MNTX 0.115 Immediate Very satisfied 13 100 MNTX 0.365 No MNTX 0.365 Immediate Somewhat satisfied 15 40 MNTX 0.065 Immediate MNTX 0.055 Immediate Very satisfied 17 50 MNTX 0.050 Immediate MNTX 0.095 Immediate Somewhat satisfied 20 85 MNTX 0.025 Immediate MNTX 0.040 Immediate Very satisfied 21 75 MNTX 0.011 Immediate MNTX 0.013 Immediate Very satisfied [0080] Oral-cecal transit time data are presented in FIG. 3. The transit times for subjects in the placebo group (n=11) at baseline and after placebo injection were 126.8±48.3 (60-195) min and 125.3±45.0 (60-180) min, respectively. The transit times for subjects in the methylnaltrexone group (n=11) showed that the study drug reduced the transit time from the baseline level of 132.3±36.0 (60-180) min to 54.5±19.3 (30-105) min. The average change in the methylnaltrexone group (−77.7±37.2 (min) was significantly greater than the average change in the placebo group (1.4±12.0 min) (P<0.001). There were no statistical differences in oral-cecal transit times between genders. [0081] Peak plasma levels of 11 subjects in methylnaltrexone group for Day 1 and Day 2 were 162±237 (30-774) ng/ml and 166±177 (33-658) ng/ml, respectively. The percentage of the intravenous dose excreted, unchanged in urine from 0 to 4 hr for Day 1 and Day 2 was 23.7±10.5 (9.6-39.9) % and 37.6±17.8 (13.2-73.6) %, respectively. [0082] Discussion [0083] The effect of opioids on gastrointestinal motility and transit is well appreciated as a clinical phenomenon. Opioids inhibit gastric emptying and propulsive motor activity of the intestine, thereby decreasing the rate of intestinal transit and producing constipation. It has been shown that opioid receptors and endorphins are widely distributed in the central nervous system and throughout the gastrointestinal tract. Based on data obtained from previous animal experiments, the site of opioid action (central vs. peripheral) of exogenous opioid-induced gut motility change or constipation is still controversial (Daniel, et al., Gastroenterology, 36:510-523 (1959); Stewart, et al., J. Pharmacol Exp. Ther., 205: 547-555 (1978); Tavani, et al., Life Sci., 27:2211-2217 (1980); Galligan and Burks, J Pharmacol Exp. Ther., 226:356-361 (1983); Manara, et al., J. Pharmacol Exp. Ther., 237:945-949 (1986)). Since the translation of animal experiment data in the literature to humans is problematic due to differences in the physiology of the opioid systems, the action site for opioid-induced constipation in humans remains a matter of investigation. Methylnaltrexone, a peripheral opioid receptor antagonist, very effectively reversed chronic opioid constipation in this clinical trial. The data in these examples provide the first strong evidence that the methadone constipating effect in humans is predominantly mediated by receptors located in the peripheral gastrointestinal tract. [0084] All 11 subjects who received intravenous methylnaltrexone had an immediate laxation response, and all reported some degree (mild to moderate) of abdominal cramping prior to their bowel movement. We interpret their abdominal cramping as a physiological desire to defecate, because the cramping disappeared after their bowel movement. Because the half-life of methylnaltrexone is approximately two hours, one would expect that cramping caused by hyperactivity of the gut to be much more prolonged. [0085] The lactulose hydrogen breath test was used, and subjects always received placebo the morning of Day 1 to establish an oral-cecal transit time baseline. Compared to baseline levels, we observed a significant reduction in gut transit time in all subjects after methylnaltrexone treatment. This result is consistent with the methylnaltrexone-induced clinical laxation response in these individuals. Lactulose, a non-absorbable osmotic agent that acts in the colon by increasing water content of the stool without directly stimulating gut peristaltic activity, may have laxative effects itself and could affect interpretation of our results. However, the dose used in this study (10 g) is ½ to ⅓ of a single dose and ⅙ th {fraction (1/12)} th the daily dose recommended to produce soft stools. This small dose of lactulose had no effect in our study, as indicated by the absence of a laxation response as well as no change in oral-cecal transit time in the placebo group. [0086] A relatively wide dose range of intravenous methylnaltrexone was used to achieve clinical laxation. In terms of individual subjects, however, the laxation doses for Day 1 and Day 2 were very similar, and no tachyphylaxis was noticed. In this study, no opioid withdrawal symptoms were observed in our chronic methadone subjects, which further indicates that methylnaltrexone does not penetrate into the brain in humans. None of the 11 subjects in the methylnaltrexone group experienced significant side effects. EXAMPLE 3 Effects of Oral Administration of MNTX on Chronic Opioid-Induced Constipation [0087] Since oral medication is a safer and more convenient way to deliver drugs than is intravenous administration, the efficacy of oral MNTX in relieving constipation in methadone maintained patients was evaluated. Twelve constipated adults (≦2 stool/week) were enrolled. Their daily methadone dose was 73.3±16.2 mg (41-100 mg), mean±SD (range). On day 1 at 9 AM, subjects ingested 10 g lactulose (Solvay Pharmaceuticals) to assess oral-cecal transit time as described above, and a placebo capsule. On day 2 at 9 AM, subjects again received lactulose, and a capsule containing methylnaltrexone (Mallinckrodt). Ascending oral methylnaltrexone doses (0.3, 1.0, and 3.0 mg/kg) were given to 3 groups of 4 subjects per group. Drug administrations were single-blinded to the subject. Laxation response and potential opioid withdrawal were recorded and blood samples were collected. [0088] None of the 12 subjects showed laxation response to placebo on day 1. On day 2, 3 out of 4 subjects had a bowel movement 18.0±8.7 hr (8-24 hr) after receiving 0.3 mg/kg MNTX. All subjects in the 1.0 mg/kg group and 3.0 mg/kg group had bowel movements at 12.3±8.7 hr (3-24 hr) and 5.2±4.5 hr (1.2-10 hr) after receiving oral compound, respectively. Most subjects reported very mild abdominal cramping after oral MNTX. Bowel movements, in most cases, were loose and in large quantity. There was no opioid withdrawal in any subjects, and no adverse effects were reported. Dose-related reduction of oral-cecal transit times is shown in FIG. 4. Oral MNTX has a significant dose-response effect (p<0.05) using the Spearman rank correlation coefficient test and linear regression model. Eight subjects had undetectable methylnaltrexone in their plasma. Peak plasma level for another 4 subjects (one from 1.0 mg/kg group and three from 3.0 mg/kg group) was 17.8±6.6 ng/ml (10-26 ng/ml). EXAMPLE 4 Effects of MNTX on Patients Administered Opioids Non-Chronically [0089] Subjects [0090] With approval from the Institutional Review Board at the University of Chicago, seven men and seven nonpregnant women were enrolled in this double-blind, randomized placebo-controlled study. Mean age±SD was 25.8±8.4 years: age range was 18 to 43 years. Subjects were screened for drug abuse disorders or medical contraindications that would keep them from participating in the study. [0091] Protocol [0092] Subjects fasted from midnight the night before the study day and were admitted for each experimental day (or session) in the morning to the Clinical Research Center at the University of Chicago Medical Center. Sessions were separated by at least 1 week. Each session lasted approximately 7 hours, and the subjects received one of three injections: (1) placebo plus placebo, (2) placebo plus 0.05 mg/kg morphine, or (3) 0.45 mg/kg methylnaltrexone plus 0.05 mg/kg morphine. Injection 1 was given at the first session, and the subjects were blinded to the medication. Injections 2 and 3 were given in a random order, and the subjects and observers were blinded to the medication. Injection assignments were prepared by random selection on a computer and were sealed in envelopes. Drug preparation and administration was done by a physician who did not participate in subject observation and data acquisition. [0093] After completion of the above three injections, we asked six of the subjects, beginning with those who had completed the study last, to return for a fourth injection (0.45 mg/kg methylnaltrexone plus 0.1 mg/kg morphine). This was done to evaluate the effects of methylnaltrexone with a higher does of morphine. [0094] Drugs [0095] The following drugs were used: morphine sulfate (Elkins-Sinn, Cherry Hill, N.J.), N-methylnaltrexone bromide (Mallinckrodt Specialty Chemicals, St. Louis, Mo.), and lactulose (Duphalac, Solvay Pharmaceuticals, Marietta, Ga.). [0096] Statistics [0097] Results of the hydrogen breath test after different injections were analyzed with the use of the Wilcoxon matched-pairs signed-rank test, with p<0.05 considered to be statistically significant. The Mann-Whitney U test was used to evaluate statistical differences between genders in oral-cecal transit times and in cold-indicted paid scores. [0098] Results [0099] Two female subjects were excluded from the study after the first (placebo plus placebo) session. One of them showed a relatively high and unstable baseline H 2 peak value (12 ppm) 2 hours after drinking lactulose. H 2 production requires a colonic bacterial flora capable of fermenting carbohydrate and yielding H 2 . In in vivo studies of humans who had ingested lactulose and in vitro studies of fecal incubates with varying carbohydrates, H 2 was not produced in 2% to 27% of individuals tested. [0100] Oral-Cecal Transit Time [0101] Oral-cecal transit times are reported in FIG. 5. Transit time increased after morphine administration in all 12 subjects and methylnaltrexone prevented the morphine-induced delay in every subject. Morphine significantly increased oral-cecal transit time from a baseline level of 104.6±31.1 minutes (mean±SD) to 163.3±39.8 minutes p<0.01). Methylnaltrexone plus morphine did not increase transit time (106.3±39.8 minutes, not significant compared with baseline; p=0.56). Methylnaltrexone prevented 97% of morphine-induced changes in oral-cecal transit time (p<0.01 compared with morphine alone). There were not statistical differences in oral-cecal transit times between genders. Table 3 summarizes the results. TABLE 3 Pharmacokinetic parameters for 0.45 mg/kg intravenous methylnaltrexone in 12 subjects Subject No. C max (ng/ml) AUC (ng/ml · hr) V d β (L/kg) t 1/2 β (min) CL (L/hr) F U (%) 1 3059 747 84.7 112.5 45.2 39.5 2 3119 677 82.4 106.3 46.5 40.4 3 4033 742 76.4 95.8 47.8 35.1 4 2640 658 87.7 87.5 60.1 34.0 5 2111 549 107.3 124.6 51.7 33.8 6 4309 694 166.9 162.6 61.6 36.5 7 1921 595 140.7 203.1 41.6 43.5 8 2418 637 246.9 238.1 62.2 26.6 9 5471 588 96.2 84.9 68.1 49.6 10 4076 1013 44.3 93.5 28.4 73.4 11 3443 634 139.2 114.2 73.2 44.4 12 2993 587 108.7 151.8 43.0 46.0 Mean ± SD 3299.4 ± 122.6 676.8 ± 122.6 115.1 ± 53.1 131.2 ± 48.7 52.5 ± 12.8 41.9 ± 11.8 [0102] Discussion [0103] Humans do not appreciably de-methylate methylnaltrexone. Results from a phase I trial with eight normal volunteers showed that doses of methylnaltrexone up to 0.32 mg/kg did not cause side effects; doses of 0.64 to 1.25 mg/kg were associated with transient orthostatic hypotension (Foss et al., unpublished data, 1993). [0104] The effect of opioids on gastrointestinal motility and transit is appreciated as a clinical phenomenon. However, the mechanism of the opioid constipating action is not fully understood. The major factors responsible include the delay of gastric emptying and changes in the motility and transit in the small intestine and the colon. Increased intestinal absorption may also contribute to morphine-induced constipation because of the change in the consistency of the stools. In this study, we observed a significant delay in oral-cecal transit time after intravenous morphine injection in human subjects and the delay was effectively antagonized by concomitant administration of methylnaltrexone. This result suggests that methylnaltrexone can reverse morphine-induced peripherally mediated effects on the gastrointestinal tract. [0105] In the United States, approximately 500,000 patients die of cancer annually. Opioid pain medication is used in the terminal phase of care for over 50% of these patients, and constipation, a significant clinical problem, affects 40-50% (approximately 125,000) of patients with metastatic malignancy who receive opioid pain medications (Schug, et al., J. Pain & Symptom Management, 7:259-266 (1992); Wingo, et al., Ca: A Cancer J. for Clin., 45:8-30 (1995)). A significant number of hospice patients receiving chronic opioids for pain would rather endure their pain than face the severe incapacitating constipation that opioids cause. [0106] Results described herein demonstrate that chronic methadone subjects are very sensitive to intravenous methylnaltrexone compared to normal opioid naive subjects in a previous trial, who received 0.45 mg/kg methylnaltrexone without any laxation response (Yuan et al., Clin. Pharnacol Ther., 59:469-475 (1996)). Comparison of the results of Example 4 with Examples 1-3 demonstrates the increased responsiveness of chronic opioid patients to the effects of methylnaltrexone. Lower doses of methylnaltrexone provide constipation relief to these patients comparable to that observed in normal patients administered higher doses of methylnaltrexone. Thus, patients having increased sensitivity to methylnaltrexone, such as chronic methadone users or cancer patients receiving chronic opioids, can benefit from very low doses of methylnaltrexone to manage their opioid induced constipation. This invention can substantially improve the quality of life for terminally ill patients and others chronically using opioids. [0107] The preceding description and Examples are intended to be illustrative. Those skilled in the art to which the invention pertains will appreciate that alterations and changes in the described protocols may be practiced without departing from the meaning, spirit, and scope of this invention. Therefore, the foregoing description should be read consistent with and as support to the following claims, which are to have their fullest and fair scope.

1a

FIELD OF THE INVENTION [0001] The present invention relates to the field of food preparation. More particularly, the invention relates to apparatus and method for preparing a decorated cake. BACKGROUND OF THE INVENTION [0002] Edible rolled fondant, which is a type of sugar paste rolled out like a pie crust, is used by professional bakers to cover a cake. The rolled fondant generally includes gelatin or agar, as well as food-grade glycerine for maintaining the sugar pliable and producing a dough-like consistency, and may be colored and flavored. [0003] After the fondant is sufficiently rolled and softened, it is lifted off the worktable and carefully adhered onto the cake, while ensuring that the entire top and sides of the cake are covered in a wrinkle-free manner. The fondant covering helps the cake underneath to stay moist, and constitutes a smooth support surface to which other edible decorations such as fine royal icing and selectively shaped three-dimensional elements can be applied. [0004] Due to the time consuming process for preparing and applying rolled fondant, the cost of a decorated cake is high. [0005] It is an object of the present invention to provide an apparatus and method for reducing the costs for preparing a decorated cake. [0006] Other objects and advantages of the invention will become apparent as the description proceeds. SUMMARY OF THE INVENTION [0007] The present invention provides a kit for preparing a decorated cake, comprising a hollow receptacle that is shaped and dimensioned, essentially according to a desired size and shape of a cake to be prepared; an edible and ready to use rolled fondant applied to, and in engagement with, at least most of an inner face of said receptacle to define a fondant interior; and a cover for releasably covering said receptacle and for retaining said fondant in a fresh condition, wherein a ready to serve decorated cake is exposable upon introduction of cake material into said fondant interior and inversion and subsequent removal of said receptacle. [0008] In one aspect, the kit comprises a plurality of the hollow receptacles each of which is of a different size and nested one within the other, wherein a corresponding ready to use rolled fondant is applied to, and in engagement with, at least most of an inner face of each of said receptacles, and wherein the cover releasably covers said plurality of receptacles. [0009] The present invention is also directed to a method for preparing a chilled decorated cake, comprising the steps of applying an edible and ready to use rolled fondant to an inner face of a hollow receptacle to define a fondant interior; introducing cake material into said fondant interior; sufficiently chilling said receptacle together with said fondant and said introduced cake material to prevent adhesion of said fondant to said receptacle; inverting said receptacle until a fondant engaged cake is lowered onto a tray; and lifting said receptacle so as to be separated from said tray and to expose said fondant engaged cake. BRIEF DESCRIPTION OF THE DRAWINGS [0010] In the drawings: [0011] FIGS. 1-8 are a method for preparing a decorated cake, according to an embodiment of the invention; [0012] FIGS. 9-13 are a method for preparing a decorated cake, according to another embodiment of the invention; [0013] FIG. 14 is an exploded view of a kit for preparing a decorated cake, according to another embodiment of the invention; [0014] FIG. 15 is a front view of a cake prepared with the kit of FIG. 14 ; and [0015] FIG. 16 is a perspective view from the top and side of a hollow receptacle formed with one or more three-dimensionally shaped ornamental cavities. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0016] FIGS. 1-8 illustrate a method for quickly applying rolled fondant to a cake, according to one embodiment of the present invention. [0017] By using the term “fondant” it is meant to include any edible crust, made of sweet dough and used to coat surfaces of a cake, so as to decorate the cake and add flavor to its texture. Such an edible crust may include marzipan, as well as gum paste or sugar paste. [0018] FIG. 1 illustrates a kit 10 for preparing a decorated cake, according to one embodiment of the invention. Kit 10 comprises a hollow receptacle 3 , e.g. cardboard mold, that is shaped and dimensioned according to the desired size of a cake to be prepared, a ready to use rolled fondant 5 applied to, and engagement with, the inner face of receptacle 3 , and a cover 7 , e.g. planar, for covering receptacle 3 and retaining fondant 5 in a fresh and appetizing condition. [0019] Fondant 5 is a three-dimensional shell made of sugar paste, or any other edible paste, well known to cover and decorate a cake. The shell may be smooth, configured with two or three dimensional patterns or by different shapes and sizes. Fondant 5 may also have edible inserts, and be imprinted or otherwise provided with selected edible indicia or other decorations. [0020] After cover 7 is removed, as shown in FIG. 2 , to make the hollow interior 8 of receptacle 3 and fondant 5 accessible, a cream filling 11 is applied to fondant 5 at the bottom of interior 8 , as shown in FIG. 3 . A cake layer 12 , e.g. a sponge cake or any other type of cake, is applied onto cream filling 11 , and then a second cake layer 17 is applied to a second cream layer 14 , as shown in FIGS. 4 and 5 . Alternatively, any other previously prepared cake in an upside-down orientation may be lowered into interior 8 so as to be interfaced with fondant 5 . [0021] The introduced cake or cake and cream layers may be individually or commercially prepared. Alternatively, the kit may also be provided with a cake mix, a cream filling, or other sugar paste decorations. [0022] An upside-down tray 15 , which may also provided with the kit, is then positioned on the top of receptacle 3 , as shown in FIG. 6 . The receptacle is then inverted such that the planar element of the tray 15 is positioned on an underlying surface and the fondant, together with the introduced cake material therewithin, is lowered onto the tray. After receptacle 3 is lifted and separated from tray 15 as shown in FIG. 7 , a ready to serve decorated cake 20 overlying tray 15 becomes exposed. Fondant 5 tends to harden to a certain extent over the course of time, and therefore will essentially not adhere to receptacle 3 when the latter is lifted. Decorations may be applied to cake 20 . [0023] FIG. 9 illustrates a kit 30 according to another embodiment of the invention. Kit 30 comprises three hollow receptacles 3 , 23 and 26 of different sizes nested one within the other. Each of the receptacles is arranged such that its bottom is downwardly positioned and its interior is accessible from above. Applied to, and engagement with, the inner face of each of the receptacles 3 , 23 and 26 is a corresponding ready to use rolled fondant. The interior of receptacles 3 , 23 and 26 is covered by cover 27 . [0024] After receptacles 23 and 26 are removed from receptacle 3 and separated, as shown in FIG. 10 , cake and cream material is added to the interior of each of the receptacles, as illustrated in FIG. 11 . [0025] With reference to FIG. 12 , receptacle 3 is then inverted, to discharge therefrom first level cake 20 . Afterwards, receptacle 23 is inverted, to discharge therefrom second level cake 35 onto the top of first level cake 20 . Receptacle 26 is then inverted, to discharge therefrom third level cake 40 onto the top of second level cake 35 . A ready to serve decorated cake 50 shown in FIG. 13 , suitable as a wedding cake, is thereby produced. [0026] As may be appreciated from the above description, the kit of the present invention enables a fondant covered cake to be quickly and easily produced, together with a unique personal design. The method may be implemented for commercial, mass produced applications. [0027] For additional cost savings, the receptacle may be reused, such as when made of plastic or is metallic. A more efficient cake preparing method may be realized when both a baking station and a receptacle inverting station are equipped with the same sized receptacle, to ensure that the baked cake will be introducible into the fondant interior prior to being inverted. Thus the discharging of the baked cake from the baking station may be synchronized with the transfer of a fondant applied receptacle to the receptacle inverting station. [0028] In another embodiment of the invention, the fondant is ensured of being retained in applied relation to the outer receptacle by means of an inner securing receptacle. By retaining the fondant in applied relation to the outer receptacle, the design of the fondant is advantageously able to be displayed to the consumer at a store, thereby increasing the appeal of a kit. [0029] FIG. 14 illustrates a kit 55 for preparing a two-layered cake 60 shown in FIG. 15 . Ready to use hollow fondant 51 is two-tiered such that the upper tier is of a smaller width than that of the lower tier. Outer receptacle 53 is also two-tiered, and fondant 51 is inserted within, and applied to the inner surfaces of, outer receptacle 53 , so as to have a complementary shape of the latter. Outer receptacle 53 is provided with a lip 54 which is engageable with cover 59 . Two-tiered securing receptacle 63 is insertable within the interior of fondant 51 , and serves to urge fondant 51 towards outer receptacle 53 when cover 59 is engaged with lip 54 and contacts the wider portion of securing receptacle 63 . Kit 55 also comprises decoration 65 that is received within the interior of securing receptacle 63 . [0030] The cake material may be baked within securing receptacle 63 . After being baked, the cake material is removable from receptacle 63 and temporarily positionable on top of cover 59 , also serving as the tray, after which it is introduced into the fondant interior. Outer receptacle 53 is then inverted until fondant engaged cake 60 is lowered onto cover 59 . Securing receptacle 63 may be reused. [0031] A kit may be envisioned to prepare a cake of any other desired number of tiers in similar fashion. [0032] According to another embodiment as illustrated in FIG. 16 , the closed bottom surface 72 of hollow receptacle 75 is formed with one or more three-dimensionally shaped cavities 77 recessed from surface 72 , such as in the form of flowers or the illustrated exemplary Mickey Mouse design. [0033] In use, ready rolled fondant is adapted to be applied to the inner face of bottom 72 and side 73 surfaces of receptacle 75 , whether manually or by a mechanized process. After pressure is applied to the fondant, such as by a securing receptacle, the fondant is urged into cavity 77 and assumes the three-dimensional shape. Upon filling the interior of receptacle 75 with previously prepared cake material and inverting the receptacle, the latter may be removed to expose the fondant engaged cake, which is produced with an ornamental protrusion protruding from the fondant and complementary to the shape of cavity 77 . This protrusion may be selectively colored as well known by those skilled in the art, such as by food coloring. [0034] Alternatively, selectively colored fondant is applied (e.g., by injecting), whether manually or by a mechanized process, into a suitable region of cavity 77 to produce the three-dimensional ornamental projection. The main fondant is then applied to bottom 72 and side 73 surfaces of receptacle 75 , as well as to the applied colored fondant, after which cake material is introduced into the interior of receptacle 75 . [0035] The hollow receptacle may also be pre-partitioned into separate members, which can be disconnected from each other by horizontal displacement, in order not to twist three-dimensionally shaped ornamental protrusions or indentations. These separate members may include handles, to allow proper grasping when separating between members. [0036] While some embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried out with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of persons skilled in the art, without exceeding the scope of the claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This invention relates to Wheel Assembly for a Toy (Inventor: Wai Hui), Assembly for Retaining a Toy (Inventor: Wai Hui), Transmitter for Radio-Controlled Toy (Inventor: Art Harrelson), and Radio Frequency Toy Controller Design (Inventor: Wai Hui) filed on the same day herewith. FIELD OF THE INVENTION [0002] The invention relates generally to mobile toys, and more particularly to certain improvements in such toys. BACKGROUND [0003] Many different types of toys are known and have become widespread and popular over the years. In particular, radio-controlled toys, such as radio-controlled cars, have become very popular with children over the years. A disadvantage of such toy cars, however, is that generally speaking they are fixed in design and cannot be changed. This means that a child can often become bored with them after a period of time. Furthermore, many children express satisfaction with being able to build or work on a toy themselves. Yet, many radio-controlled cars are complex and have components which are complicated and not easily adapted to be built or switched out by children. What is needed is a radio-controlled toy having easily interchangeable components such that a child may be able to build or customize their own toys. [0004] Additionally, radio transmitters used by radio-controlled toys are often complex and difficult to operate. Some transmitters are used to charge the radio-controlled toys for use by providing a charging means on the transmitter for connecting to the toy. Often, it is difficult to tell whether charging has been completed, thereby wasting valuable power associated with the charging means. Therefore, what is needed is a transmitter having an easy to understand control panel. [0005] A third aspect of this invention relates to an assembly for retaining a radio-controlled toy on a transmitter while it is being charged. It is often difficult to align the toy with the charging mechanism used to charge the toy. Furthermore, upon alignment, it is difficult to maintain a good connection between the charging mechanism and the toy, which can lead to intermittent, and therefore, inefficient charging. Therefore, what is needed, is an easy to use and reliable means for aligning and retaining the toy on the transmitter during charging. BRIEF DESCRIPTION OF THE DRAWINGS [0006] [0006]FIG. 1 is a perspective view of a toy car according to one embodiment of the invention. [0007] [0007]FIG. 2 is a perspective view of a rear wheel assembly associated with the toy car of FIG. 1. [0008] [0008]FIG. 3 is an exploded view of the wheel assembly of FIG. 2. [0009] [0009]FIG. 4 is a perspective view of a front wheel assembly associated with the toy car of FIG. 1. [0010] [0010]FIG. 5 is an exploded view of the wheel assembly of FIG. 4. [0011] [0011]FIG. 6 is a side sectional view of a hubcap of the wheel assembly of FIGS. 2 and 4. [0012] [0012]FIG. 7 is a perspective view of a toy car and a transmitter according to another aspect of the invention. [0013] [0013]FIG. 8 is an exploded view of the toy car and transmitter of FIG. 7. [0014] [0014]FIG. 9 is a schematic view of the transmitter of FIG. 7. [0015] [0015]FIG. 10 is a partial bottom sectional view of the transmitter taken along the line 10 - 10 depicted in FIG. 8. [0016] [0016]FIG. 11 is a partial side sectional view of the transmitter taken along the line 11 - 11 depicted in FIG. 8. [0017] [0017]FIG. 12 is an isometric view of a kit to be used with the invention. DETAILED DESCRIPTION [0018] Referring to FIG. 1, a toy car is generally referred to by reference numeral 10 . The car 10 comprises a body 12 for connecting to a chassis 14 . The body 12 may connect to the chassis 14 in a variety of ways including but not limited to a conventional pressure fit or a snap connection. Thus, the body 12 is interchangeable with the chassis 14 . [0019] Removable Hubcaps [0020] The chassis 14 includes a rear axle arrangement (not depicted) for supporting a pair of substantially similar rear wheel assemblies 16 (one of which is shown) to provide the car 10 with mobility. The chassis 14 further includes a front independent suspension arrangement (not depicted) for supporting a pair of substantially similar front wheel assemblies 18 (one of which is shown). [0021] For clarity of description, one wheel assembly 16 will be described. Referring to FIGS. 2, 3, and 6 , the wheel assembly 16 comprises a wheel 20 fixed to the axle arrangement for rotation therewith. The wheel assembly 16 further comprises a hubcap 24 adapted to be quick-detachable to the wheel 20 . It is understood that quick-detachable means that the hubcap 24 may be attached to and detached from the wheel 20 without the use of tools. The wheel assembly 16 further comprises a tire 26 adapted to be quick-detachable to the wheel 20 . [0022] The hubcap 24 comprises a front portion 28 and a rear portion 30 . The front portion 28 of the hubcap 24 may comprise a variety of different designs depending on the desired aesthetical nature of the hubcap. The rear portion 30 is the portion of the hubcap 24 that interfaces with the wheel 20 . The rear portion 30 comprises at least one protrusion 32 extending away from the rear portion for engaging at least one corresponding bore 34 disposed through the wheel 20 to attach the hubcap 24 to the wheel. It will be understood that the hubcap 24 may comprise any number of protrusions 32 and the wheel 20 may comprise any number of corresponding bores 34 . The engagement between the protrusion 32 and the bore 34 may comprise a variety of connections, such as a conventional snap connection. Furthermore, although the hubcap 24 is described as being quick-detachable to the wheel 20 , the hubcap 24 may alternatively be attached to the wheel 20 in such a manner as to require the use of a tool for removal. [0023] A circumferential edge of the hubcap 24 has a tab 36 extending radially outward from the hubcap. The tab 36 comprises a beveled side 38 sloping from the rear portion 30 of the hubcap 24 towards the front portion 28 of the hubcap. When the hubcap 24 is attached to the wheel 18 , the tab 36 provides a means for disengaging the hubcap 24 from the wheel 20 in a quick-detachable manner. [0024] Furthermore, a concentric bore 40 is formed through the hubcap 24 for receiving a corresponding hub 42 extending outwardly from the wheel 20 . Such an arrangement provides a means for aligning the hubcap 24 with the wheel 20 during attachment of the hubcap to the wheel. [0025] To further aid in alignment, the wheel 20 may comprise a rim 44 extruded along the radial outward side of the wheel. A slot 46 is formed in the rim 44 to receive the tab 36 during attachment. Thus, the bore 40 and the hub 42 along with the tab 36 and the slot 46 cooperate to provide a means for aligning the hubcap 24 and the wheel 20 during attachment of the hubcap to the wheel. [0026] The tires 26 comprise an outer circumferential surface 50 and an inner circumferential surface 52 . A variety of tread patterns may be formed on the outer surface 50 of the tires 26 . The inner surface 52 comprises a channeled groove 54 formed to fit to an extruded ring 56 extending along a circumferential surface 58 of the wheel 20 . Thus, the groove 54 and the ring 56 cooperate to provide a means for laterally retaining the tire 26 on the wheel 20 . Furthermore, the tire 26 may be formed of an elastic material, such as rubber, so that the elastic properties of the tire radially retains the tire on the wheel 20 . [0027] Referring now to the front wheel assemblies 18 , one of which is shown in FIGS. 4 and 5, a shaft 60 of the independent suspension arrangement is adapted to receive a wheel 62 via a bore 64 formed through the wheel and an annular flange 66 of the wheel. The flange 66 extends in an outward direction from the wheel 62 in a coaxial relationship with the shaft 60 . The shaft 60 is riveted at one end to provide a means for retaining the wheel 62 to the chassis 14 . The remaining aspects of the wheel assembly 18 are substantially similar to the wheel assembly 16 described above and are therefore given the same reference numerals. [0028] In operation, the hubcap 24 is aligned for attachment to the wheel 20 by aligning the hub 42 of the wheel with the corresponding bore 40 formed through the hubcap. The hubcap 24 may be similarly aligned for attachment to the wheel 62 by aligning the riveted end of the shaft 60 and the annular flange 66 with the corresponding bore 40 formed through the hubcap. The hubcap 24 may be further aligned with the wheel 20 by aligning the tab 36 with the corresponding slot 46 formed in the rim 44 . Upon alignment, the hubcap 24 may be pressure fit to the wheel 20 by applying pressure to the hubcap in a direction towards the wheel. [0029] If detachment of the hubcap 24 from the wheel 20 is desired, the hubcap may be detached by engaging the beveled side 38 of the tab 36 via a thin object, such as a fingernail or the like, and applying pressure on the tab in a direction away from the wheel. Thus, the hubcap 24 may be quick-detachably connected to the wheel 20 . Such detachability allows a user to use many different types of hubcaps 24 with the car 10 . [0030] Once the hubcap 24 has been attached to the wheel 20 , the tire 26 may be attached to the wheel to complete the wheel assembly 16 . The tire 26 may be fitted to the wheel by aligning the groove 54 with the ring 56 of the wheel 20 . Thus, like the hubcaps 24 , the tires 26 may be quick-detachably connected to the wheel 20 , which allows the user to use many different types of tires 26 with the car 10 . [0031] Transmitter [0032] Referring to FIGS. 7 and 8, in an alternative embodiment, a radio-controlled toy car 70 is depicted, which requires the use of a wireless controller, or alternatively described as a transmitter, 72 to transmit radio signals for operation of the car in a conventional manner. The car 70 is substantially similar to the car 10 described previously except that the car 70 is adapted to receive radio signals for operation thereof. The transmitter 72 comprises an antenna 73 to send radio signals to a corresponding antenna 74 disposed on the car 70 . It will be understood that the antenna 74 is operatively connected to a wireless receiver (not depicted) to receive the radio signals from the transmitter 72 . In some embodiments, the antenna 74 may comprise a telescoping arrangement. [0033] The transmitter 72 comprises a housing 76 having a front 78 , a side 80 , and a top 82 . The front 78 of the housing 76 comprises a control panel, such as a pair of controls 84 , which may be actuated by a user to control movement of the car 70 via a control circuit (not shown) within the transmitter 72 . The controls 84 are housed within raised portions 85 of the housing 76 . The front 78 of the housing 76 further comprises a switch 86 for activating the control circuit and a charging circuit located within the transmitter 72 to be described with reference to FIG. 9. A transparent indicator casing 90 is disposed above the switch 86 for housing a three-way indicator, such as an LED, also to be described with reference to FIG. 9. Furthermore, a release button 91 is disposed on the front 78 of the housing 76 and proximate to the controls 84 for providing a means for releasing the car 70 from the transmitter 72 to be described with reference to FIGS. 10 and 11. [0034] A recess 92 may be formed in the side 80 of the housing 76 for releasably retaining a tool 94 , such as a screwdriver, associated with the car 70 . The tool 94 may be releasably retained via a conventional pressure fit. It will be understood that the tool 94 may be releasably retained within the housing 76 in a variety of ways. Furthermore, the recess 92 may be formed in a variety of locations within the housing 76 . [0035] The top 82 of the housing 76 comprises a charging pad 96 for charging a battery (not shown) housed within the car 70 . A pair of slots 98 are formed through the charging pad 96 for allowing a plug 100 associated with the charging circuit to pass there through for engaging a corresponding jack (not shown) associated with the car 70 . An additional slot 102 is formed through the charging pad 96 for allowing a spring 103 to pass there through for supporting the car 70 on the charging pad. A further additional slot 104 is formed through the charging pad 96 for allowing a catch 106 operatively connected to the release button 91 to pass there through. The catch 106 is adapted to engage a corresponding groove (not shown) formed on the underside of the car 70 to releasably retain the car on the transmitter 72 in a manner to be described with reference to FIGS. 10 and 11. The catch 106 also aids in aligning the car 70 on the charging pad 96 during placement of the car on the charging pad for charging. [0036] A flange 108 and a lip 110 are disposed on and extend away from the charging pad 96 to provide a further means for aligning the car 70 on the charging pad during placement of the car on the charging pad for charging. [0037] A cover 112 is operatively connected to the housing 76 for enclosing the charging pad 96 and the antenna 73 during nonuse. The housing 76 of the transmitter 72 comprises a step-down portion 113 for accommodating movement of the cover 112 from an open position to a closed position. A protrusion 114 extends from the step-down portion 113 for receiving a corresponding bore 116 formed through a flange 117 of the cover 112 for connecting the cover to the housing 76 . It will be understood that the opposite portion of the cover 112 comprises a substantially similar arrangement. [0038] A stepped flange 118 further extends from the charging pad 96 and is adapted to engage a lip 119 of the cover 112 to secure the cover in a closed position. [0039] Referring to FIG. 9, there is illustrated a schematic circuit for the transmitter 72 . The circuit comprises a charging circuit 120 for transferring power to the rechargeable battery (not shown) of the car 70 , and a transmitting circuit 121 for sending radio signals to the car. The charging circuit 120 may be activated by manipulation of the switch 86 by the user. The charging circuit 120 utilizes a transistor Q 4 to control the flow of current through a current limiting resistor R 15 . The transistor Q 4 is in turn controlled by a timer transistor Q 8 , which ends the current transmission at a predetermined cutoff time. The predetermined time is controlled by a resistor/capacitor combination that is connected to the gate of the resistor Q 8 . The drain of the transistor Q 8 is connected to the base of a transistor Q 7 and the collector of a transistor Q 5 . It is understood that while specific resistor types (e.g., bipolar junction transistors and field effect transistors) are utilized in the present illustration, different types of transistors may be substituted. [0040] An indicator, which for purposes of illustration is a multi-color light emitting diode (LED) able to produce red or green light, may be connected to the circuit and used to indicate a state of the circuit. A first anode (for red light) of the LED is connected to the base of a transistor Q 6 and a second anode (for green light) of the LED is connected to ground through a diode D 7 and a resistor R 10 . The LED's common cathode is connected to a power source 122 . The behavior of the charging circuit and its various states may be indicated by means of the LED as follows. [0041] Prior to activation of the circuit 120 , the LED will not be illuminated, thus indicating that the transmitter is off. Upon activation of the circuit 120 but prior to charging of the car 70 , current will pass through the second anode of the LED, producing green light and indicating that the transmitter is on. Upon contact between the plug 100 and the corresponding jack of the car 70 , current will pass through the first anode of the LED, producing red light and indicating that the transmitter is charging the car. Finally, upon expiration of the predetermined cutoff time, the LED may revert back to the green color to indicate completion of charging of the car 70 . The various states of the circuit, and therefore the transmitter, are displayed to the user via the indicator casing 90 (FIGS. 7 and 8). [0042] Release Assembly [0043] Referring to FIGS. 10 and 11, the transmitter 72 may house a release assembly 130 for releasably retaining the car 70 on the charging pad 96 . The release assembly 130 includes the release button 91 , which is disposed through a bore 132 formed in the housing 76 of the transmitter 72 . The button 91 comprises a rod 134 extending from the exterior of the housing 76 through the bore 132 and into an annular recess 136 defined by a sleeve structure 138 within the housing 76 . [0044] A rim 140 is formed integrally with the rod 134 and extends around a portion of the rod 134 . It will be understood that the rim 140 may alternatively be a separate component that attaches to the rod 134 in a coaxial relationship with the rod. A coil spring 142 is coaxially positioned about a portion of the rod 134 adjacent to the rim 140 and into the annular recess 136 . The rim 140 engages the spring 142 to provide a means for biasing the rod 134 against the inside surface of the housing 76 via a stop 143 associated with the rod. The diameter of the sleeve 138 is substantially the same as the diameter of the spring 142 . Therefore, the rim 140 , the spring 142 , and the rod 134 are stably maintained in the sleeve 138 formed within the transmitter 72 . [0045] The button 91 further comprises a flange 144 having a beveled surface 146 for engaging an actuator 148 associated with the button. The actuator 148 comprises a stepped portion 150 having a coiled spring 152 positioned coaxially there about. The spring 152 abuts a fixed surface 154 and provides a means for biasing the actuator 148 against the flange 144 . It will be understood that the fixed surface 154 is formed of additional structure 155 that is not pertinent and will not be discussed. [0046] The actuator 148 is coupled to a catch 156 via a coupling device 158 . The coupling device 158 is adapted to impart opposing motion, in a lateral direction, between the actuator 148 and the catch 156 upon depression of the button 91 . The catch 156 comprises an elongated surface 160 at its distal end for engaging and retaining the car 70 on the transmitter 72 . The catch 156 extends from the transmitter 72 in a direction substantially perpendicular to the longitudinal axis of the button 91 . The resulting orientation of the catch 156 and the button 91 is ergonomically advantageous as it minimizes the user's movement to depress the button and remove the car 70 from the transmitter 72 . [0047] In operation, the car 70 may be charged for use by aligning the catch 156 with the corresponding groove formed on the car and applying pressure to the car in a direction towards the transmitter 72 to snap the car into the charging position. If further alignment is necessary, the flange 108 and the lip 110 may be used to align the car 70 on the charging pad 96 . Upon arranging the car 70 on the charging pad 96 , the charging circuit may be activated by actuating the switch 86 . Upon activation, the indicator emits a red color, which can be seen via the indicator casing 90 , to indicate charging of the car 70 . [0048] When charging of the car 70 is completed, as indicated by the indicator emitting a green color, the car may be released from the charging pad 96 by depressing the release button 91 and pulling the car in a direction away from the transmitter 72 . By releasably retaining the car 70 on the transmitter 72 via the release assembly 130 , difficulties associated with charging radio-controlled cars, such as unstable connections, can be avoided. Upon release of the car 70 from the transmitter 72 , the car may be controlled via the transmitter in a conventional manner by manipulation of the controls 84 . [0049] Toy Kit [0050] In another embodiment of the present invention, a kit 160 for providing various unassembled components of the car 70 is depicted in FIG. 12. The kit 160 may include any of the components discussed above, including the body 12 , the chassis 14 , the wheels 20 and 62 , the removable hubcaps 24 , the tires 26 , the transmitter 72 , and the tool 94 . The kit may further comprise a rear axle gear 162 and an axle 163 , a transfer gear 164 , a motor clip and screw assembly 166 , and a motor with drive gear 168 . It will be understood that the motor with drive gear 168 provides power to the car 70 . Furthermore, a wrist strap 170 may be included for attaching to the transmitter 72 to prevent accidental dropping of the transmitter. [0051] In operation, according to one embodiment, the car 70 may be assembled by first assembling the front wheel assemblies 18 in the manner described above. The motor with drive gear 168 may then be inserted into a motor compartment 172 disposed in the chassis 14 . Upon insertion of the motor 168 , the motor retaining clip and screw assembly 166 may be fitted over the motor by engaging a pair of hooks 174 with a rod 176 secured to the chassis 14 , and further threading a screw 178 of the assembly to a corresponding threaded bore 180 disposed through the chassis. The tool 94 may be used to aid insertion of the screw 178 into the bore 180 . The transfer gear 164 may then be inserted onto a portion of the rod 176 extending from the chassis 14 via a bore 182 disposed through the gear 164 . Upon attachment of the transfer gear 164 , the axle 163 may be snap-fitted into a corresponding groove 184 of the chassis 14 , thereby also assembling the axle gear 162 on the chassis. Thus, the drive gear of the motor 168 engages with the transfer gear 164 , which thereby engages with the axle gear 162 . Next, the rear wheel assemblies may be assembled in the manner described above. Finally, the antenna (not shown) may be threaded through a bore 186 formed through the body 12 and the body snap-fitted to the chassis 14 . It will be understood that the above steps of assembly are for example only and the assembly of the car 70 may comprise a different order of steps. It will be further understood that the above components of the kit 160 may comprise a housing (not shown) for maintaining the components of the kit in an enclosed space. [0052] The kit 160 may be further modified by providing additional bodies 12 for providing the user with the option of interchanging body styles with the chassis 14 . Furthermore, the body 12 and the hubcaps 24 may resemble actual body and hubcap styles to associate the car 70 with actual cars. [0053] In addition to the utility of operating the car 70 , the user gains the added utility of assembling the car using the above-described components of the kit 160 . [0054] It is understood that the above spatial references, such as “radial,” “lateral,” “inward,” and “outward,” are for the purpose of illustration only and do not limit the specific orientation or location of the structures described above. [0055] Though the invention has been described with respect to a specific preferred embodiment, many variations and modifications will become apparent to those skilled in the art upon reading the present application. It is therefore the intention that the appended claims be interpreted as broadly as possible in view of the prior art to include all such variations and modifications.

1a

FIELD OF THE INVENTION [0001] The invention concerns a crop pick-up arrangement with a height gauge arrangement with a pivot arm assembly that is supported in bearings so as to pivot vertically at the rear region of the crop pick-up arrangement and a height gauge arrangement. BACKGROUND OF THE INVENTION [0002] U.S. Pat. No. 6,152,240 discloses a crop pick-up arrangement with support wheels, each of which is attached by means of a pivot arm assembly to a side wall. The pivot arm assembly is retained by means of a vertical and a horizontal bearing and can be pivoted vertically as well as horizontally in such a way that the support wheel can be pivoted in a free space behind the crop pick-up arrangement in order to reduce its transport width. [0003] WO-A1-98/17096 teaches the attachment of a support wheel at each side of a so-called pick-up by means of a pivot arm assembly that is configured in the shape of an inverted “U”. The size, shape, and arrangement of the pivot arm assembly is selected in such a way that a large free space exists between the wheel and the pick-up which prevents harvested crop from accumulating there. [0004] EP-A-383 121 and EP-368 430 each show an agricultural harvesting machine with a roller feeler arrangement where on each side of a crop pick-up arrangement several roller feelers are attached to a pivot arm assembly spaced at intervals in direction of operation in a tandem or dual swinging arrangement. [0005] The problem underlying the invention is seen in the fact that the roller feelers must either be pivoted at great technical cost or disassembled during transport on public roads due to the great width of the crop pick-up arrangement. SUMMARY OF THE INVENTION [0006] According to the present invention there is provided an improved height gauge arrangement for a crop pick-up or the like. [0007] An object of the invention is to provide a height gauge arrangement that includes a combination of a gauge wheel and a skid shoe. [0008] Another object of the invention is to provide a height gauge arrangement for use with a crop pick-up including pick-up devices such as transversely spaced tines, with the skid shoe being narrower than the spacing between the pick-up devices. In this way, the pivot arm assembly for the skid shoe can be located within the effective width of the crop pick-up arrangement and can be supported on the ground so that the skid shoe has room between the pick-up devices of the crop pick-up arrangement or between these and the ground. Accordingly, the skid shoe can extend into the pick-up region of the crop pick-up arrangement and thereby react before these come into contact with an obstacle or an irregularity in the ground. Since the pivot arm assembly is supported on the wheel at the end opposite the skid shoe and thereby forms a lever arm about a bearing located in between, the lift path is reduced. [0009] If the skid shoe is narrower than the spacing between the pick-up devices of the crop pick-up arrangement, it can extend between these, does not hinder these, and can be configured to almost such a height as the pick-up devices project beyond the stripper vanes of the crop pick-up arrangement. [0010] A plate-shaped skid shoe can be arranged underneath the pick-up devices due to its flat configuration and thereby can be configured considerably wider, which results in a low ground pressure. Vertical stiffening frames and ribs can be provided between the pick-up devices that protect the skid shoe against bending. [0011] The position of the pivot point of the pivot arm assembly on the wheel, generally underneath the point at which the crop pick-up arrangement is attached to a rotobaler or a similar harvesting or crop recovery machine, leads to an adequate sensitivity when uneven ground is encountered on the one hand, and on the other hand, excessively strong reactions are avoided. [0012] If several skid shoes are provided, for example, three to ten, the ground pressure of each individual skid shoe is reduced on the one hand, and on the other hand, the likelihood is reduced so that there is no reaction to an obstacle. Several skid shoes can be connected to the pivot arm assembly by means of a sort of balance arrangement or equalization arrangement so that the pivot arm assembly is actuated only if an obstacle is detected, for example, by two adjacent skid shoes. In this way, the possibility is also avoided that the crop pick-up arrangement is lowered, if the skid shoe, for example, sinks into a furrow. [0013] The skid shoes and the wheels and possibly even the wheels of the machine to which the crop pick-up arrangement is attached could be arranged in one alignment; but this is not mandatory. Rather, an offset arrangement of the skid shoes and wheels can have the result, for example, in case a skid shoe steps into a furrow, then the wheel rolling to the side of the furrow can provide at least a minimum of support. Furthermore, in this way the spacial relationships of the configuration can be considered. A pivot shaft provided for this purpose extends over the crop pick-up arrangement so far as is required in order to engage all skid shoes and wheels. [0014] An elastic configuration of the pivot arm assembly, for example, that is composed of an elastic material or that is composed of several parts or arms connected to each other elastically, has the advantage that load peaks, particularly at high contact velocities, can be avoided. On the other hand, load peaks can also be avoided by the provision of a spring of any desired type between the skid shoe or the wheel and the pivot arm assembly. [0015] Rounded edges on the skid shoe reduce the danger of harvested crop or other objects becoming caught on the skid shoe during skidding over the ground and accumulating there. Particularly, the frictional resistance is reduced during the skidding over the ground. [0016] A preload of the pivot arm assembly, relative to the crop pick-up arrangement, is established in such a way, that with the skid shoe located at the underside of the crop pick-up arrangement, there is the advantage that the skid shoe does not dig into the ground upon the lowering of the crop pick-up arrangement and is thereby possibly damaged; rather, the wheel is forced downward thereby so that it first touches the ground upon the lowering of the crop pick-up arrangement and then rolls along the ground, without experiencing any problems. If, in another embodiment, the preload operates in such a way that the wheel is pivoted upwards, this may have advantages during transportation over public roads, since the wheel comes to rest at a lower position than the skid shoe does when the crop pick-up arrangement is pivoted upward. In summary, the preload is applied in such a way and at such locations where it is useful in order to avoid the damage due to an uncontrolled movement of the pivot arm assembly. [0017] The use of at least one stop in the one, the other or in both directions, prevents the pivot arm assembly with the skid shoe and the wheel from being pivoted too far away from the crop pick-up arrangement, and then projects so far that it could be a hindrance or hangs up during transport or in the operation. [0018] Height gauge arrangements with the aforementioned characteristics can also be treated as independent units and can be attached subsequently to existing crop pick-up arrangements. Particularly, with rotobalers, rectangular balers, self-loading forage boxes, forage harvesters, swath pick-up arrangements, and the like, it is then possible to use crop pick-up arrangements, whose possible pick-up width corresponds generally to the maximum allowable transport width on public roads. BRIEF DESCRIPTION OF THE DRAWINGS [0019] The drawing shows an embodiment of the invention that shall be described in greater detail in the following. [0020] [0020]FIG. 1 is a schematic, left side view of an agricultural machine with a crop pick-up arrangement and a height gauge arrangement constructed according to the invention. [0021] [0021]FIG. 2 is a front view of the crop pick-up arrangement of FIG. 1. [0022] [0022]FIG. 3 shows an enlarged side view of the height gauge arrangement and the crop pick-up arrangement of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT [0023] Referring now to FIG. 1, there is shown an agricultural harvesting machine 10 with a frame 12 that is supported by wheels 14 on the ground and can be coupled to a towing vehicle by means of a towbar 16 . Baling rolls 18 surround a baling chamber 20 in which crop to be baled, which was taken up from the ground by a crop pick-up arrangement 22 , can be compressed into a bale. The baling chamber 20 extends through a forward, fixed housing part 24 and a rear housing part 26 , forming a discharge gate that can be raised for the ejection of a cylindrical bale. [0024] On each side of the crop pick-up arrangement 22 , a height gauge arrangement 28 is located, with which the crop pick-up arrangement 22 can be gauged at a certain height above the ground. [0025] The agricultural machine 10 described so far corresponds to a rotobaler of conventional configuration. Indeed, the use of the height gauge arrangement 28 according to the invention is limited neither to a rotobaler of the type shown nor to a rotobaler at all. Rather, other agricultural machines can be considered, for example, another baler, a self-loading forage box, a forage harvester, a combine, and the like. [0026] The crop pick-up arrangement 22 may be a pick-up as well as a cutter head, a corn head or the like, and can extend over the maximum width allowed for the transport on public roads. As can be seen, in particular in FIG. 2, the crop pick-up arrangement 22 includes tines 30 circulating vertically in horizontally spaced rows that leave a spacing 32 between them that is covered by stripper vanes 34 . The tines 30 and the stripper vanes 34 are carried by a frame 36 to a rear side of which is fixed a pair of transversely spaced rear walls 38 that extend vertically beside walls of the frame 12 and contain a bearing 40 to which the frame 36 is coupled so as to pivot vertically. The bearing 40 is located above and to the rear of the frame 36 , but ahead of the support wheels 14 . The crop pick-up arrangement 22 can be repositioned in height by means of actuating arrangements, not shown, for example, linkages, rope pulls, hydraulic motors, etc., in order to occupy thereby an upper transport position or to slide along the ground for crop pick-up. In the lower crop pick-up position, the crop pick-up arrangement 22 can float according to the surface of the ground. Other than for the height gauge arrangement 28 , the crop pick-up arrangement 22 is of conventional configuration. [0027] The height gauge arrangement 28 includes a pivot arm assembly 42 , wheels 44 , skid shoes 46 , a pivot shaft 48 , and a bearing 50 . [0028] In the disclosed embodiment, the height gauge arrangement 22 is configured as an assembly that is attached to the underside of the crop pick-up arrangement 22 and extends almost or generally over its entire width. Indeed, it would also be possible to configure it in each case with only one component (pivot arm assembly 42 , wheel 44 , skid shoe 46 , pivot shaft 48 , and bearing 50 ) and to locate the narrower assembly at a location between opposite ends of the crop pickup arrangement 22 . [0029] While in the disclosed embodiment two wheels 44 and three skid shoes 46 are provided, fundamentally one wheel 44 and one skid shoe 46 would be adequate. On the other hand, more than two wheels 44 and three skid shoes 46 could be provided, as long as this is practical and technically useful. [0030] Compared to the support wheels 14 , each wheel 44 is of a relatively small diameter and is used for supporting the pivot arm assembly 42 on the ground, when the skid shoes 46 encounter an obstacle. The wheels 44 are located to the rear of the pivot shaft 48 , or as seen in FIG. 1, to the right of the shaft 48 . Each wheel 44 is engaged, free to rotate in an end region of an arm 52 , whose other end region is retained radially to the pivot shaft 48 . The wheels 44 may be provided with solid or pneumatic tires. In a simple configuration, the arms 52 may be retained and fixed against rotation on the pivot shaft 48 . In the embodiment shown, however, they are supported in bearings on the shaft 48 , free to pivot. [0031] The skid shoes 46 also extend radially from the pivot shaft 48 and are connected to it, fixed against rotation. Although the skid shoes 46 are shown, according to FIG. 3, connected directly to the pivot shaft 48 , the description in the following nevertheless is based on the fact that only the forward region shows a skid shoe 46 that is connected by an arm 54 with the pivot shaft 48 or that extends to it. As seen in FIG. 2, the right-hand skid shoe 46 is also configured in such a way that it fits between the tines 30 , and in the extreme case, can be brought into contact with the underside of the stripper vanes 34 , without colliding with the tines 30 . On the other hand, it would also be possible to releasably attach wider plates 55 to the underside of the skid shoes 46 , as shown at the middle and left-hand skid shoes 46 , which plates 55 extend outside of the operating region of the tines 30 . The plates 55 act to minimize the ground pressure. Furthermore, the removable plates 55 have the advantage that they could easily be replaced in case of wear or damage. Alternatively, the skid shoes 46 in themselves could be configured in the shape of a plate. In a further embodiment, in place of fixed skid surfaces, rolls, wheels or the like could also be used. At the end opposite the skid shoe 46 , each arm 54 extends beyond the pivot shaft 48 and forms a support arm 55 that extends in the form of a scissors to the arm 52 . [0032] The pivot shaft 48 is preferably provided with a non-circular profile, for example, hexagonal, and extends preferably over the entire width of the height gauge arrangement 28 . Alternatively, each wheel 44 could be connected with one or several skid shoes 46 . The pivot shaft 48 engages, so as to-rotate, at the rear lower corner region of the crop pick-up arrangement 22 by means of the bearings 50 and is secured in the axial direction by means not shown. [0033] A spring 56 is provided between the shaft 48 and the frame 36 of the crop pick-up arrangement 22 , which constantly resists counterclockwise movement of the shaft 48 and hence, downward movement of the skid shoe 46 , so that particularly when the crop pick-up arrangement 22 is raised, the skid shoes 46 do not project downward and collide with an obstacle, without being able to evade it, while a contact of the wheel 44 , then located at the bottom and able to move upward, leaves it undamaged. [0034] While the spring 56 is shown in the drawing as a torsion spring, a multitude of other springs could also be used, for example, leaf springs, helical compression springs, helical extension springs or even gas springs or the like. The spring 56 is retained at one end by means of an eye (not shown) and a screw 57 received in a bore provided in the shaft 48 , and is in contact at its other end under a preload at the rear, lower edge of the frame 36 , which indeed could also be configured differently. [0035] The bearings 50 are configured in the usual manner as slide bearings, roller bearings or ball bearings that are fastened in bearing shells 51 on the underside of the frame 36 . [0036] The spring 56 or several springs 56 are particularly useful to retain the skid shoes 46 generally upward in addition to the pivoting moments about the pivot shaft 48 due to the weight of the associated masses upon very uneven ground. [0037] The arms 52 for the wheels 44 are formed more or less from a flat steel strip with high bending strength. The arms 54 for the skid shoes 46 are configured comparably to the arms 52 . If the arms 54 simultaneously form the skid shoes 46 , they can be configured in a “J”-shape, as is shown in FIG. 3, so that they can slide along the ground on the outer bend of the “J” instead of on its edge. [0038] The arms 52 and 54 can extend on the pivot shaft 48 immediately alongside each other, or spaced to the side alongside each other. In another embodiment, they can also be combined and configured as a one-piece component. In the embodiment shown, their longitudinal axes extend at an angle between them of approximately 140°. Since the arm 52 of the wheel 44 is supported in bearings, free to move on the pivot shaft 48 , the relative position between the arms 52 and 54 is maintained by means of a very strong spring 60 configured as a helical compression spring that can engage with one end the support arm 55 and with its other end on the upper side of the arm 52 . A screw 62 extends through the spring 60 and is secured in the support arm 55 as well as in the arm 52 , and is used to retain the spring 60 in its place as well as to maintain the angular spread between the arms 52 and 54 at a minimum. Accordingly, the spring 60 on the one hand and the screw 62 on the other hand provide the assurance that the two arms 52 and 54 can be repositioned relative to each other within a certain region under a preload. [0039] A depression 66 , which is semi-circular in side view, is provided on the upper side of the arm 52 in a location for receiving a stop 68 , carried by the frame 36 when the pivot arm assembly 42 pivots to an extreme counterclockwise position. The stop 68 can be configured as a screw, a pin, a welded part or the like and can be attached to the frame 36 rigidly or so that it can be repositioned. The depression 66 and the stop 68 are located on a circular arc about the center of the pivot shaft 48 . [0040] On the basis of the above description, the operation is as follows: During operation, the crop pick-up arrangement 22 and the height gauge arrangement 28 take the position shown in FIG. 3, in which the pick-up devices 30 brush over the ground, and the skid shoes 46 , as well as the wheels 44 , touch the ground. If the crop pick-up arrangement 22 is moved to the left as seen in FIG. 3, that is, forward, and if a skid shoe 46 makes contact with an obstacle 64 , then the crop pick-up arrangement 22 moves upward. Thereupon, a pivoting movement of the pivot arm assembly 42 , together with the pivot shaft 48 , is performed in the clockwise direction. Since the wheel 44 is located on the ground and held there by the action of the coil compression spring 60 , the crop pick-up arrangement 22 is raised in the region of the pivot shaft 48 . As soon as the obstacle has been overcome, the skid shoe 46 is lowered again; and with it, the crop pick-up arrangement 22 is also lowered. In an embodiment in which the wheel 44 is offset to the side with respect to the skid shoe 46 , the wheel 44 will not also roll over the obstacle 64 and will not lead to a renewed raising of the crop pick-up arrangement 22 . [0041] Having described the preferred embodiment, it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.

1a

This application claims priority of U.S. Provisional Application No. 60/104,232 filed in the United States Patent and Trademark Office on Oct. 14, 1998, the entirety of which is incorporated by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a system and method for an auditory ear prosthesis. In particular, the present invention relates to the construction of a strut for connecting the medial surface of the stape footplate with the wall of the saccule. 2. Description of the Related Art One type of conventional hearing aid provides for an air-conduction amplifying system such that a microphone picks up air conduction sounds, amplifies them and presents them in the ear canals as an air conduction signal to the eardrum. Such hearing aids offer a small frequency range as well as a small dynamic range of intensity. Another type of conventional hearing aid is called a bone conduction hearing aid, which has been developed for users where the conventional air-conduction hearing aid is not satisfactory in improving hearing for those users. A bone conduction hearing aid is attached to the head of the user, and the output from a microphone pick-up is amplified and fed into a device which causes bone vibration. These devices operate over a small dynamic range and are designed principally for persons whose middle ears could not be surgically repaired or for very young children who have abnormalities of the middle ear that cannot be surgically repaired until they are older. As such, bone conduction hearing aids are rarely used. Another type of conventional hearing aid involves implanting rare earth magnets in the temporal bone, and a microphone electronic coil system is used to cause the magnets to vibrate. The vibration of the magnets produces bone conduction hearing. These devices are also rarely used because of the surgery involved in drilling out the bone and installing the magnets therein. Another type of hearing aid utilizes the supersonic frequency band, such as from 20,000 Hz and above, as disclosed in U.S. Pat. No. 4,982,434, which is incorporated in its entirety herein by reference. In such supersonic-frequency hearing aids, air conduction sounds in the audiometric range (from 100 Hz to about 10,000 Hz) are frequency-shifted to about 108 kHz or higher, and then these supersonic frequencies are transmitted by bone conduction or the like to the human sensory system. These signals are delivered by a bone conduction attachment, such as a high fidelity electrical to vibrator transducer, functionally connected for bone conduction in the head. In U.S. Pat. No. 4,982,434, it was hypothesized that the supersonic hearing aid provides hearing to the user based on a system of hearing quite distinct from normal hearing based on air conduction. Instead, it uses bone conduction and parallels the primary hearing response of reptiles. In some reptiles, there is reduced air conduction hearing in reference to bone conduction. Hearing is mediated via both the cochlea and the saccule. In man, the saccule has been considered an organ responsible for balance and determining acceleration and movement. In reptiles, the saccule is a hearing instrument and it possesses hearing potential in amphibia and is the hearing organ of fish as well. The evolution of the mammalian ear has spanned nearly 200 million years. Reptilian mammals responded to selective pressures and developed very sensitive air borne receivers with wide frequency ranges. The closest living relative to the common ancestor of these reptilian mammals are the extant turtles. While turtles hear a restricted range of frequencies, they preferentially process sound in the form of vibration. Turtles have at least two sensory receptors in their inner ears, the cochlea and the saccule. The cochlea is stimulated by bone conduction, which is different from the means of conduction in mammals. However, there also exists in turtles a physical connection between the wall of the saccule and the middle ear bone (stapes), with this physical connection not existing in mammals. Thus, when sound strikes the eardrum of a turtle, both the cochlea and the saccule are stimulated. In the case of a mammal, the saccule is isolated from direct contact with the stapes, and only very intense vibration of the stapes is translated to a corresponding vibration in the saccule. The mammalian auditory system developed a sensitive receiver by evolving a thin, taught eardrum connected to a three-bone middle ear system that is capable of matching impedances between sound in air and vibration in inner ear fluid (perilymph). This ear development in sensitivity and in frequency range may have been detrimental to the saccule if it remained directly coupled to the middle ear. A very sensitive receiver may have exerted too much displacement on the saccule, hence overloading it. As such, it is hypothesized that the disarticulation of the saccule from the stapes may have been an adaptive mechanism for mammals. The supersonic hearing aid as disclosed in U.S. Pat. No. 4,982,434 was believed to utilize direct bone transmission to the saccule, thereby enabling hearing to be maintained via a system independent of air conduction and the inner ear, although integrated with the air conduction system. The supersonic hearing aid may not be suitable for every patient. Accordingly, there is a need to provide alternative approaches for saccule-mediated hearing. SUMMARY OF THE INVENTION It is an object of the present invention to provide a method and a system of inner ear activation through a prosthesis that connects the saccule to the stapes of a human ear. The above-mentioned object and other advantages may be obtained by an auditory prosthesis system for a human inner ear that includes an eardrum, a saccule and a stapes. The system includes at least one strut that is disposed between the saccule and the stapes. Movement of the stapes is directed to the saccule by way of the at least one strut. The above-mentioned object and other advantages also may be obtained by a method of implanting a hearing aid device into an inner ear of a human, the inner ear including a saccule and a stapes. The method includes a step of affixing one end of a strut to the stapes, wherein the strut has a hollow middle for receiving a material. The method also includes a step of applying the material into the hollow middle of the strut, thereby causing the other end of the strut to contact the saccule. Physical movement of the stapes caused by movement of an eardrum is directed to the saccule by way of the strut. The above-mentioned object and other advantages also may be obtained by a method of implanting a prosthesis into an inner ear to enhance hearing. The method includes a step of providing a strut between a saccule and a stapes of the inner ear, thereby providing a direct contact between the saccule and the stapes. The strut provides direct stimulation of the saccule based on stimulation of the stapes. BRIEF DESCRIPTION OF THE DRAWINGS The above-mentioned object and advantages of the invention will become more fully apparent from the following detailed description when read in conjunction with the accompanying drawings, with like reference numerals indicating corresponding parts throughout, and wherein: FIG. 1 is a block diagram of the flow of sound from the external ear sensed as pressure, converted to vibration by the inner ear stimulating the cochlea and the saccule through an implanted stapedial-saccular strut and converted to neural signals in the nerve and the brain; FIG. 2 is an enlarged block diagram of the saccule and the stapes interfacing with the stapedial-saccular struts according to the invention; FIG. 3 is a diagram of a dissected marine turtle middle ear showing the natural fibroelastic strands that connect the saccule to the stapes; FIG. 4 shows comparison audiograms of a human with a severe loss of hearing above 1000 Hz (human loss), of a red ear turtle, and a typical tuning curve of an auditory fiber in the apex of a mammalian cochlea (mammal); FIG. 5 shows a similarity between an auditory nerve fiber in the apex of a cat cochlea and a saccular nerve fiber in the cat that responds to sound; FIG. 6A shows the actual saccular nerve response to two fibers in the cat; FIG. 6B shows a typical cat audiogram; FIG. 7 shows the spatial relation between the footplate of the stapes and the saccular wall for a human inner ear; FIGS. 8A and 8B show detailed distance data between the stapes and the saccular wall, with that data being obtained from an article on the human ear; and FIGS. 9A and 9B show the structure of a sleeve used to form and position a strut according to the invention, in an unfilled and a filled state, respectively. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is directed to a method and a system for an implanted auditory vestibular prosthesis, or stapedial-saccular strut, which functions as a coupler of middle ear vibration to the saccule of the vestibular system. The method and system provide additional stimulation to the saccule when external signals are applied to the ear by either air conduction and/or bone conduction. Speech recognition is boosted not only during natural conditions, but also with traditional air-conduction amplification techniques. To date, it is not believed that there has been an inner ear implantable prosthesis developed to drive the saccule by the displacement of the middle ear system, until the present invention. Inner ear implants designed to electrically stimulate the cochlea, so-called cochlear implants, are intracochlear devices. Devices to stimulate the inner ear by stimulating the round window of the inner ear currently exist, but these are middle ear implants. Implantable hearing aids also exist, but these attach to the middle ear bones, including the stapes, but only within the middle ear space. These devices do not attach to the saccule. The present invention relates to an auditory vestibular prosthesis and a method of making and implanting such a device. The prosthesis couples the middle ear bone (stapes) to the wall of the saccule, and thus corresponds to a stapedial-saccular strut. The strut is preferably a synthetic elastic connector to the saccule, and transmits stapedial displacements, which occur as a result of eardrum movements indicated by sound waves, as a vibration to the saccule. In a first embodiment, a strut is formed using a “sleeve”. The sleeve is hollow and contains a collapsed reservoir end that is distended by injection of a synthetic silicon through the sleeve. The sleeve is preferably formed of cured sylastic. The injected synthetic silicon eventually cures to achieve a solid form having a predetermined shape, to thereby form the strut or prothesis. The reservoir end of the sleeve expands due to the injection of fluid into the sleeve, and thereby allows a balloon end of the strut formed by way of the sleeve to make contact with the saccular wall and to adhere thereto. In a second embodiment, each strut is hollow (cylinder-shaped), without a collapsed reservoir end. In the second embodiment, a balloon-like formation at the distal end of the sleeve (the end nearest the saccule) is formed due to pushing each sleeve (with uncured sylastic liquid having been pumped into the hollow middle of the sleeve) in a direction towards the stapes. This pushing causes some of the liquid sylastic in the sleeve to seep out of the reservoir end of the sleeve, thereby forming a balloon-like shape at that end. As explained in the Background section, it is hypothesized that the disarticulation of the saccule from the stapes may have been an evolutionary process for mammals. This may have been due to: a) excellent sensitivity of the human ear by air conduction, and b) wide frequency range of the human ear. In the case of a human experiencing some degree of hearing loss, these two factors are no longer present. The embodiments of the present invention provide a coupling of the stapes to the saccule in cases of pronounced sensorineural hearing loss, in order to increase the number of sensory elements responding to sound. This may also increase speech reception and intelligibility. A block diagram of an embodiment of the present invention is given in FIG. 1 . Sound enters the ear canal. The sound displaces the eardrum and middle ear bones 105 , thereby stimulating the cochlea 140 , which in turn provides corresponding signals to the eighth nerve 150 , which in turn provides corresponding signals to the brain 160 . Referring now to FIGS. 1 and 2, in one embodiment of the present invention, at least one synthetic stapedial-saccular strut (SSS) 100 is disposed between the footplate of the stapes 120 and the saccular wall 130 . By this connectivity, the saccule 130 is physically coupled (via the SSS 100 ) to the middle ear 105 , resulting in the simultaneous stimulation of both endorgans (saccule 130 and cochlea 140 ) when sound moves the eardrum. The strut itself is formed into the inner ear using a sleeve having a cylindrical shape with a hollow middle. Sylastic in solid form is readily available in sheets, and a sheet can be fashioned into a tube, to thereby create the sleeve. The stapedial-saccular struts 100 can be positioned by drilling a hole for each strut 100 near the center of the footplate 120 , and then inserting each sleeve at a location close to the center of the footplate 120 . Other approaches can be undertaken for positioning and attaching the strut to the footplate 120 . Preferably, each sleeve is inserted a small amount into a hole drilled in the footplate 120 . Each sleeve 100 is preferably a small diameter (e.g., 0.02 mm) bioactive (or biocompatible) polymer. By way of example and not by way of limitation, each strut 100 is constructed of a biocompatible organic polymer, such as sylastic or a water swell hydrophilic gel, or the like. The actual length of the struts 100 depends on the physical characteristics of the particular ear in which the struts 100 are to be inserted. This length may be determined by a variety of ways, such as by taking a magnetic resonance image (MRI) of the patient's head, to thereby determine the distance between the stapes 120 and the saccule 130 for that patient. Once that distance is determine, properly-sized struts may be constructed, and then inserted into the appropriate position within the ear. The inserting of the sleeves that provide the “template” for the strut formation in the inner ear may be performed in any of a variety of ways, such as by using a hypodermic needle to implant the struts into the hollow middle portions of the sleeves. In accordance with the first embodiment of the present invention, each sleeve (being formed from cured sylastic) has a small reservoir end that expands when the sleeve is filled with sylastic in liquid (uncured) form. Sylastic is biocompatible with the inner ear tissue, and is an ideal compound for providing a prosthesis in the ear. The expanded reservoir end will make contact with the saccular wall, and form a kind of fluid spring. In accordance with the second embodiment of the present invention, each sleeve is formed from cured sylastic into a hollow cylinder, and uncured, liquid sylastic is pumped into the hollow middle of the sleeve. The liquid sylastic is pumped into the sleeve after the sleeve has been inserted into a central position on the footplate of the stapes where a hole has been drilled. The sleeve is pulled back from the saccular wall to allow the liquid sylastic in the middle of the sleeve to balloon at the saccular wall end. This forms a strut having a balloon-like end, as the liquid sylastic cures in that particular shape. In the first embodiment, there is no need to pull the sleeve back, since the liquid sylastic is pumped into the sleeve at an amount enough to fill the reservoir end of the sleeve to a desired size. As discussed above, multiple struts can be used to ensure adequate coupling between the stapes and the saccule. In each of the embodiments of the present invention, the perilymph that is displaced by the introduction of the strut is siphoned off, preferably through a tap in the stapes, and sealed after implantation of the stapes. That way, the ambient pressure of the inner ear is maintained. Perilymph is the inner ear fluid that is bridged by the strut, and when the strut is inserted into the ear, some of the perilymph must be siphoned off, or else the strut will displace the existing perilymph and it will bulge the oval window (where the stapes is situated) and the round window (which is located a few mm below the oval window). Preferably, the amount of fluid siphoned off will equal the displacement fluid by the strut. The appearance of the struts in the human ear will be similar to that in the turtle model shown in FIG. 3 . The number of struts implanted for the human ear will typically be far less than the number of fibroelastic strands 320 in the turtle inner ear that connect the turtle saccule 310 to the turtle stapes 330 , but the mechanical results will be similar. The turtle (red ear slider) audiogram is shown in FIG. 4 . The turtle ear is not very sensitive to frequencies about 1000 Hz. A human with little hearing above 1000 Hz reveals a similar relative (sensation level re: best frequency hearing) audiometric plot, as also shown in FIG. 4 . Additionally, the nerve fibers in the apex of a mammalian cochlea that are broadly tuned in the low frequencies also share the same basic audiometric configuration, as also shown in FIG. 4 . As can be seen from these audiograms, the human with a severe hearing loss above 1000 Hz, the turtle and the auditory fiber from the apex of the cochlea share quite similar frequency characteristics. That is, hard of hearing humans, with intact apical portions of their cochleas, have a similar auditory sensitivity in frequency range to turtles. The plots in FIG. 4 are in dB sensation level (SL), which is determined by arbitrarily setting the most sensitive frequency as a reference frequency and by referencing other frequency points to that reference frequency. If there are few receptor (hair) cells remaining in a damaged human cochlea, amplification in the high frequencies for an air-conduction type of hearing aid will have little benefit, while high level amplification in the low frequencies will not be well tolerated. With increasing low frequency loss, the only alternative for air-conduction type of hearing aids is to increase the level of amplification. The present invention, however, offers an alternative to the use of amplification alone. For a patient having a damaged cochlea, when the saccule is coupled to the middle ear by the use of the implanted struts, both the damaged cochlea and the saccule are stimulated simultaneously by the sound coming into the ear. The saccule auditory fibers are tuned much like that of the auditory fibers of the base of the cochlea. The fibers of the saccule have a similar shape based on the data available, which is shown in FIG. 5 . FIG. 5 provides a comparison of the frequency response of an auditory nerve fiber in the apex of a mammalian cochlea with that of a saccular nerve fiber that responds to sound in a cat. Referring now to FIGS. 6A and 6B, for a cat saccule, some saccule fibers can be stimulated naturally by sound if it is intense (95 dB SPL, which is 115 dB above threshold, 115 dB SL). Note that the saccular fibers do not begin to fire until the sound level is 115 dB SL. The threshold of the saccular fiber at 1000 Hz is about 95 dB SPL and the audiogram of a cat at 1000 Hz is about −20 dB SPL. The data plotted in FIGS. 6A and 6B was obtained from various articles on audiograms of a cat: Costalupes (1983); Elliot, Stein and Harrison (1960); Heffner and Heffner (1985); Neff and Hind (1955); Miller and Covel (1963). If the saccule was connected to the stapes, such as by using one or more struts in accordance with the present invention, the threshold of the saccular fibers would be much lower due to the direct transmission of vibration to the saccule. The struts according to the embodiments of the present invention provide the direct transmission path. The basic phenomenon of saccular hearing for mammals has been known, and the details of cat saccular hearing is described in an article entitled “Acoustic Responses From Primary Afferent Neurons Of The Mammalian Sacculus”, by M. P. McCue & J. J. Guinan, Jr., published in “Mass. Eye & Ear Infirmary”, Boston, Mass., 1993. However, since the saccule is not coupled to the eardrum's displacement in the human ear, the sound power has to be of sufficient strength to move the head before the saccule is stimulated. Not until the present invention has there been an approach to take useful advantage of the saccule for hearing. The implantation struts according to the embodiments of the present invention connect the footplate of the stapes to the saccular wall. The anatomy of the area of the inner ear where the struts are to be implanted is shown in FIG. 7 A. Strut 100 is placed in the 1.5 mm area (vestibule) between the saccule 130 and the base (footplate) of the stapes 120 , and connect at respective ends to these elements. The strut 100 is preferaby about 1.6 mm in length, to allow for the strut to provide some pressure on the saccular wall, with a small portion (e.g., slightly less than 0.1 mm) of the strut 100 being inserted into a hole drilled into the stapes 120 . FIGS. 8A and 8B show data values and a corresponding plot of the distance between the saccule and the stapes, based on data obtained from an article by Pauw et al., entitled “Utricle, Saccule & Cochlear Duct in Relation to Stapedotomy”, published in “Ann. Otol. Rhinol. Laryngology”, page 967, in 1991. For the embodiments of the present invention, an insertion distance of 1.6 mm is chosen as a base value to ensure safety. Of course, the exact size of the struts may vary depending upon the particular inner ear characteristics of a patient. As explained above, each of the struts is inserted about 1.6 mm into a hole drilled near the center of the footplate of the stapes. This provides a connection of one end of the struts to the stapes, while the other end is free. In one embodiment, the connection of that other end of the struts to the saccule is made by inflating a reservoir end of the sleeve with uncured, liquid sylastic, which then cures to thereby provide a “fluid spring” connection of that end of the strut to the saccular wall. In another embodiment, a pushing of the sleeve (used to create the strut) away from the saccule cause a balloon-like formation of uncured sylastic (pumped into the hollow middle of the sleeve) to form, and to cure in that shape. As discussed above, the system and method according to the embodiments of the present invention activate the saccular receptors with eardrum displacements, with those eardrum displacements being provided to the saccule via struts connecting the stapes (that moves based on movements of the eardrum) to the saccular wall. Sound entering the ear canal and activating the middle ear is capable of stimulating of endorgans, the saccule and the cochlea, when the strut is positioned between the footplate of the stapes and the saccular wall. In particular, each of the embodiments of the present invention is well-suited for persons with severe high-frequency sensorineural hearing loss. It has been found that the saccule is sensitive to sound when the cochlear contribution is eliminated by ototoxic poisoning. The threshold of the saccular response is about 70 dB above normal cochlear sensitivity, in a normal human ear. This higher threshold exists because the head must be set to vibration by the sound to activate saccular receptors. However, when a strut or struts are disposed between the footplate of the stapes and the saccule in accordance with the present invention, the saccule is mass loaded with the middle ear structures, and becomes stimulated at a lower threshold level. In certain embodiments of the present invention, a stapedial-saccular strut is positioned by first drilling a hole near the center of the footplate of the stapes. A sleeve, formed from already-cured sylastic and having a cylindrical shape with a hollow middle, is inserted into the hole drilled in the footplate. In particular, the footplate of the stapes is drilled until the bone is thin and transparent. As soon as the drilling has been performed to form the hole, the sleeve is inserted into the drilled hole. Care must be taken of course in the drilling procedure, since the stapes footplate is embedded in the oval window, and if the oval window is punctured, perilymph will escape, which may cause deafness. When the footplate is drilled to a point that it almost becomes transparent, the sleeve is immediately inserted. At this point, a drill bit may be inserted into the sleeve while the hole is only partially drilled, so that the exact depth of the hole can be accomplished with care by using the sleeve itself to achieve the desired size. In any event, the sleeve must be inserted quickly, the perilymph loss minimized, and the sylastic injected into the sleeve to thereby form the strut. Since the sleeve is hollow and made of cured sylastic, there is flexibility to seal the hole at the footplate and maneuverability before the injected liquid sylastic (into the hollow portion of the sleeve) begins to cure. The curing time is a function of the solvent mix making up the liquid sylastic, and may be modified somewhat based on experimentation as to the time needed to perform a strut insertion. In the case of a persistent leak, the sleeve itself may have to remain within the inner ear, and as long as the sleeve is moved off of the saccular wall, this is acceptable. Basically, it is important in this procedure that the hole in the stapes be sealed quickly, and that the correct amount of perilymph is siphoned off (based on displacement caused by introduction of a prothesis in the inner ear. Other types of insertion techniques to implant the strut into the footplate may be contemplated by those skilled in the art while remaining within the scope of the invention as described herein. The sealing of the hole is performed by the injecting of uncured sylastic into the hollow end of the sleeve nearest the stapes, whereby the uncured sylastic forms around the drilled hole to provide a rigid connection of the strut to the stapes when the strut cures to achieve a solid form. As discussed above, after the sleeve has been attached to the stapes, liquid silicon (e.g., sylastic) is injected into the sleeve. In the first embodiment of the invention, when the liquid silicon is injected into the sleeve, the reservoir end of the sleeve expands. The expanded end of the strut comes in contact with the saccular wall and adheres thereto. In the second embodiment of the invention that does not use a sleeve having a reservoir end, pulling of the sleeve in a direction away from the saccule causes a balloon-like formation of uncured sylastic to form at the end of the strut closest to the saccule. This balloon end provides a contact point to the saccular wall. The injecting of the uncured liquid sylastic into the hollow middle of the sleeve may be performed, for example, by placing a syringe needle at the bottom of the sleeve, then injecting the liquid sylastic from the syringe to the hollow middle of the sleeve, and then slowly withdrawing the syringe. In the preferred embodiments, the sylastic is slowly injected and the sleeve is slow removed. In this way, the needle is generally positioned near the medial end of the sleeve. In cases where the sleeve cannot be removed fully, the amount extending into the footplate is trimmed, and sealed with sylastic. Multiple struts may be used, but care must be taken to remove the quantity of perilymph displaced by the insertion of each strut into the footplate of the stapes. In the embodiments of the invention, it is preferable that the angular ligament as well as the stapedius muscle remain intact during the strut insertion process. The angular ligament keeps the stapes from too much displacement (limits the maximum displacement), which is important so that the strut is not pushed too much against the saccule when it is put in place. As explained above, the sleeve (made out of cured sylastic) forms a template for injecting uncured, liquid sylastic into the ear. Then, as the uncured sylastic starts to cure and achieve a solid form, the sleeve is removed from the inner ear. The sleeve is preferably removed since it may cause a problem with loud noise exposure, which may cause vibrations translated from the footplate to the saccular wall (by way of the strut) that may rupture the saccule. Once the sleeve is removed, the remaining cured sylastic that was pumped into the hollow middle portion of the sleeve remains, thereby forming a strut or prosthesis that provides a vibration bridge between the footplate of the stapes and the saccular wall. If, however, it is not possible to remove the sleeve during formation of the strut, then it can be left inside the inner ear, and care must be take such that the patient is not exposed to very loud noises. In these cases, a sylastic sponge may be utilized, which can be inserted into the stapes and sealed with sylastic. The sponge would provide some protection from strong stapes displacement due to loud sound stimulation. The sponge would also keep its shape, and would also adhere to the saccular wall in time. In the embodiments of the present invention, it is important to choose a strut having the correct length to fit into the space between the stapes and the saccular for a particular person. This length may be obtained by performing an MRI of the person's ear, to thereby determine that distance. As explained above, the struts are made out of biomaterials, such as biocompatible silicon, such that the strut is not extruded. Furthermore, the strut is designed so that it maintains adequate contact with the saccular wall. That end of the strut may be provided with a suitable adhesive in order to provide a reliable contact with the saccular wall. In particular, due to the injecting of uncured sylastic into a sleeve to thereby form a prothesis inside the inner ear, the sylastic balloon end of the prothesis is in contact with the saccular wall, and adhesions will naturally occur to keep it in place over time. Note that the sylastic will attach to the medial end of the strut and will cure fastest at the stapes end since it is exposed to air, and can even be “air dried”, if necessary. This air curing of the strut at the stapes end will seal the hole that was drilled into the footplate of the stapes when the strut was formed between the stapes and the saccule. Referring now to FIG. 9A, in the first embodiment of the present invention, the sleeve 900 is hollow with an expandable balloon reservoir end 110 , with that end 110 shown in the unexpanded state. The reservoir end 110 is capable of expanding when the sleeve 900 is injected with a silicon material, to thereby form a structure with an expanded end 110 , as shown in FIG. 9 B. The expanded (balloon) end 110 of the sleeve 900 makes contact with the saccular wall, and adheres thereto. The balloon is preferably constructed of a biocompatible elastic material, to ensure adequate contact with the saccular wall. In the second embodiment of the present invention, the sleeve is formed without a reservoir end, and just has a hollow, cylindrical shape. The balloon end is formed by pushing the sleeve in a direction away from the saccule, after the sleeve has been positioned between the saccule and the stapes and after uncured, liquid sylastic has been injected into the hollow middle of the sleeve to thereby form the strut. While preferred embodiments have been described herein, modification of the described embodiments may become apparent to those of ordinary skill in the art, following the teachings of the invention, without departing from the scope of the invention as set forth in the appended claims. For example, while strut was described in one embodiment as being constructed from a biocompatible organic polymer, such as sylastic, other types of biocompatible organic polymers, such as a water well hydrophilic gel or the like, may be used instead. Also, while details of a strut constructed according to one embodiment have been provided, one of ordinary skill in the art will recognize that other types of strut constructions may be envisioned to provide a prosthesis between the stapes and the saccule, while remaining within the spirit and scope of the invention as described herein. For example, as an alternative to using a sleeve to provide a structure for curing a strut inside an ear, a sylastic element can be cast outside of the ear into a desired shape, and then the cured sylastic element can be inserted into a hole drilled in the footplate of the stapes, so as to provide connectivity between the stapes and the saccule. Using this alternative, the end of the strut inserted into the hole drilled in the footplate of the stapes will not immediately bond to the stapes, but adhesions will eventually form to provide for a rigid connection of the stapes and the strut. The particular shape of the strut formed between the stapes and the saccule is described in detail, but other shapes may be envisioned. The primary purpose of the strut is to provide a “vibration bridge” between these two elements, and a strut may be configured with any particular shape that achieves this translation of vibrations in the footplate of the stapes to resultant vibrations to the saccular wall. Additionally, the extra mass of the stapes caused by the strut attached thereto may lower the frequency response of the user, which may result in additional high frequency hearing loss. However, since the invention has been developed for persons who already have high frequency hearing loss, this extra high frequency hearing loss is not that important. On the contrary, the mass loading of the stapes may, in fact, increase low frequency sensitivity, which is very beneficial to the user.

1a

PRIORITY CLAIM The present application claims priority to U.S. Provisional Application Ser. No. 61/150,090 filed on Feb. 5, 2009 entitled “Reamer and Drill Guiding Device,” the entire disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to devices for treating fractures and, in particular, relates to a device for guiding a drill or a reamer co-axially along a guidewire inserted into a bone such that an opening may be formed in the bone at a desired angle and position to accommodate the insertion of a fixation device therethrough. BACKGROUND An intramedullary nail is a device used to stabilize long bones such as the tibia or femur. The intramedullary nail is inserted into a medullary canal of the long bone to align and stabilize the bone after an opening through the cortical bone has been formed using, for example, a drill or reamer. To ensure a proper angle of insertion for the intramedullary nail, a guidewire (e.g., a k-wire) may be used to guide the drill or reamer into the bone at the desired angle. The guidewire is generally inserted into the bone at the desired angle and position and the drill or reamer is then slid over the guidewire. To attain the desired angle and position for the cortical bone opening, the drill or reamer should be co-axial with the guidewire. However, in some cases, a bending force at one end of the drill or reamer results in the drill or reamer becoming displaced such that the opening of the cortical bone is formed at an improper angle and/or position SUMMARY OF THE INVENTION The present invention is directed to a device for guiding a drilling tool to form an opening in a bone, comprising a body extending from a distal end to a proximal end, the body including a lumen extending therethrough, the lumen being sized and shaped to slidably accommodate a guidewire therein and a plurality of arms extending proximally from the proximal end, the arms being disposed about the lumen with a gripping surface of each arm being spaced radially from an axis of the guide wire lumen by a distance approximately corresponding to a thickness of a guidewire to be received therein, the gripping surfaces gripping the guidewire to maintain a portion thereof extending proximally of the lumen along the axis of the lumen. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a side view of a system according to an exemplary embodiment of the present invention; FIG. 2 shows a perspective view of a device according to the system of FIG. 1 ; FIG. 3 shows a cross-sectional side view of the device of FIG. 2 ; FIG. 4 shows another side view of the device of FIG. 2 , rotated about a longitudinal axis thereof with respect to FIG. 3 ; FIG. 5 shows a perspective view of the system of FIG. 1 , in a guiding configuration; FIG. 6 shows a cross-sectional side view of the system of FIG. 5 ; FIG. 7 shows a perspective view of the system of FIG. 1 , in a stopping configuration; and FIG. 8 shows a cross-sectional side view of the system of FIG. 7 . DETAILED DESCRIPTION The present invention, which may be further understood with reference to the following description and the appended drawings, relates to devices for treating fractures. In particular, exemplary embodiments of the present invention describe a device for guiding a drill or a reamer co-axially along a guidewire inserted into a bone such that an opening may be formed in the bone at a desired angle and position to accommodate the insertion of a fixation device therethrough. It will be understood by those of skill in the art that although the exemplary embodiments are described in regard to the formation of a cortical opening for the insertion of an intramedullary nail, the device may be used for creating a bone opening in any situation in which a guidewire is used. It should also be noted that the terms “proximal” and “distal,” as used herein, are used to describe a direction toward (proximal) and away from (distal) a user of the device. As shown in FIG. 1 , a system 100 according to an exemplary embodiment of the present invention comprises a device 102 that may be used to guide a drilling tool 104 co-axially along a guidewire 106 inserted into a bone 108 to form a cortical opening in the bone 108 at a desired angle and/or position. As shown in FIGS. 2-4 , the device 102 comprises a body portion 110 and a plurality of arms 112 . The body portion 110 extends longitudinally from a distal end 114 to a proximal end 116 and includes a lumen 118 extending therethrough from the distal end 114 to the proximal end 116 . The lumen 118 is preferably sized and shaped to slidably accommodate the guidewire 106 . In a preferred embodiment, the body portion 110 may be substantially cylindrical. However, it will be understood by those of skill in the art that the body portion 110 may take a variety of shapes and sizes. The arms 112 extend from the proximal end 116 and are positioned around the lumen 118 . Each of the arms 112 may include a contact portion 120 protruding radially inward (i.e., toward an axis of the lumen 118 ) from a proximal end 122 of a radially inner surface 124 of the arm 112 . Each of the arms 112 may also be angled inward toward the longitudinal axis of the lumen 118 such that a distance between the contact portions 120 is substantially the same as or smaller than a diameter of the lumen 118 . This permits the contact portions 120 to hold the guidewire 106 along the axis of the lumen 118 proximally beyond the proximal end of the lumen 118 . In a preferred embodiment, the device 102 includes two arms 112 . However, it will be understood by those of skill in the art that the device 102 may include any number of arms 112 so long as the arms 112 are formed about the lumen 118 with that the contact portions 120 thereof positioned to hold a guidewire 106 received within the lumen 118 on the axis of the lumen 118 . The drilling tool 104 , as shown in FIGS. 5-8 may be any device capable of drilling a hole in the bone 108 or reaming an existing hole in the bone 108 by sliding along the guidewire 106 such as, for example, a hollow drill. The drilling tool 104 includes a lumen 130 extending therethrough for accommodating the guidewire 106 . The lumen 130 of the drilling tool 104 includes a distal portion 132 sized and shaped to accommodate the device 102 and a proximal portion 134 extending proximally therefrom sized and shaped to accommodate the guidewire 106 . The lumen 130 includes a shoulder 136 angled radially outward at a point where the distal portion 132 and the proximal portion 134 meet such that a cross-section of the distal portion 132 distal of the shoulder 136 is larger than a cross-section of the proximal portion 134 proximal of the shoulder 136 . A distal end 140 of the drilling tool 104 includes a cutting edge sized and shaped to drill a desired cortical opening with an outer surface 138 of the drilling tool 104 sized shaped accordingly. As would be understood by those skilled in the art, the guidewire 106 may be any standard wire useful for guiding a drilling tool 104 therealong. For example, the guidewire 106 may be a Kirschner wire (k-wire). According to an exemplary method of use of the system 100 , a distal end 126 of the guidewire 106 is inserted into the bone 108 at a desired position and/or angle for the cortical opening. A proximal end 128 of the guidewire 106 is inserted through the lumen 118 at the distal end 114 of the device 102 and the device 102 is slid over the guidewire 106 until the distal end 114 comes into contact with the bone 108 . It will be understood by those of skill in the art that the contact portions 120 of the arms 112 hold the guidewire 106 firmly therebetween. Once the device 102 has been slid to the appropriate position, the proximal end 128 of the guidewire 106 is inserted into the lumen 130 of the drilling tool 104 such that the drilling tool 104 is slidable therealong, as shown in FIGS. 5 and 6 , in a guiding configuration. In the guiding configuration, the contact portions 120 of the arms 112 hold the guidewire 106 therebetween such that, even when a bending force is exerted on a portion of the drilling tool 104 , the drilling tool 104 will not become displaced and will be guided therealong, co-axially with the guidewire 106 . Thus, the drilling tool 104 slides co-axially along the guidewire 106 until the distal portion 132 of the drilling tool 104 , reaches the bone. Thus, the device 102 acts as a guide for the drilling tool 104 until the distal end 140 reaches the bone 108 , ensuring that the cortical opening will not be displaced or improperly drilled/reamed or damaged. During the drilling of the bone, the drilling tool 104 continues to slide distally along the guidewire 106 into the bone 108 such that the device 102 enters the distal portion 132 of the drilling tool 104 , as shown in FIGS. 7 and 8 , in a stopping configuration. As the drilling tool 104 continues to slide along the guidewire 106 and the device 102 , the drilling tool 104 continues to drill through the bone 108 . In the stopping configuration, the device 102 slides within the distal portion 132 of the lumen 130 relative to the drilling tool 104 until the device 102 comes into contact with the shoulder 136 of the lumen 130 . Thus, in the stopping configuration, the device 102 is within the distal portion 132 of the lumen 118 and acts as a stopper such that once the proximal end 136 of the distal portion 132 abuts the proximal end 122 of the arms 112 of the device 102 , the drilling tool 104 may not slide any further distally. Thus, in the stopping configuration, the device 102 stops the drilling tool 104 limiting the drilling of the cortical opening to a predetermined depth. Once the cortical opening has been drilled as desired, the drilling tool 104 , the guidewire 106 and the device 102 may simply be removed from the bone 108 such that the intramedullary nail may be inserted into the medullary canal of the bone via the cortical opening. It will be apparent to those skilled in the art that various modifications and variations may be made in the structure and methodology of the present invention, without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided that they come within the scope of the appended claims and their equivalents.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to an exercise device. More particularly, the invention concerns an exercise device permitting a user to perform alternatively a stair stepping exercise or a cross country skiing exercise, or simultaneously to perform a stair stepping exercise and a cross country skiing exercise. 2. Description of Prior Art Heretofore, various exercise devices have been provided to permit a user to perform a stair stepping exercise which simulates the climbing of stairs. Also, various exercise devices have been provided to permit a user to perform a cross country skiing exercise which simulates cross country skiing. However, none of the exercise devices heretofore have permitted in a single exercise machine, the simultaneous performance of a stair stepping exercise and a cross country skiing exercise. No prior exercise device has allowed a user to change the exercise he is doing while on the machine from stair climbing to cross country skiing to a bicycle-like motion to a backward walk motion, all without mechanical adjustment of the machine. For example, U.S. Pat. No. 3,970,302 dated Jul. 20, 1976, shows an exercise device in which a pair of foot supports are mounted for movement along an inclined track to simulate stair climbing. A pair of shock absorbers connected to the foot supports resist downward movement resulting from a downward force exerted by the feet of a user and provide upward return movement of the foot supports to a predetermined position. There is no showing of an exercise movement simulating cross country skiing. U.S. Pat. No. 4,685,666 dated Aug. 11, 1987, likewise shows an exercise device to simulate a climbing or stair stepping motion, but such exercise device does not provide a cross country skiing exercise. U.S. Pat. No. 4,733,858 dated Mar. 29, 1988, shows a multi-purpose exercise device which may be utilized to perform various exercises. The device is used in a first position to practice climbing such as climbing steps. The device is adjusted to a second position to simulate a skating motion. There is no provision for performing a climbing exercise and a skating exercise simultaneously with the device remaining in one position. U.S. Pat. No. 5,000,442 dated Mar. 19, 1990, shows a cross country ski simulator in which foot supports are mounted for generally horizontal back and forth movement with manually gripped handles controlling the movement of the foot supports and providing a resistance to the movement of the foot supports. Such ski simulator does not provide a simulated climbing or stair stepping exercise performed simultaneously with the cross country skiing exercise. Identification of Objects of the Invention It is an object of this invention to provide such an exercise device having a pair of foot supports movable in a generally vertical direction in a stair stepping exercise and movable simultaneously in a generally horizontal direction in a cross country skiing exercise. A further object of this invention is to provide an exercise device having a pair of foot supports thereon which are mounted for simultaneous movement in combined horizontal and vertical directions while the foot supports remain in a horizontal plane. An additional object of the invention is to provide an exercise device having a pair of foot supports mounted for combined generally vertical and horizontal movements with a force resisting member for each foot support in each direction. SUMMARY The invention is directed to an exercise machine or device which permits a user standing on foot supports to perform simultaneously a stair stepping or climbing exercise and a cross country skiing or skating exercise. The machine also permits alternative climbing or skiing exercises. The exercise machine includes a pair of foot supports on which the user stands to perform exercises. One preferred embodiment of the exercise machine includes a fixed support including a base and an upwardly extending support member. A linkage extends in a generally vertical direction between the fixed support and the foot supports. Each foot support is operationally connected to force resisting means including a force resisting member for resisting downward movement of the foot support and, if desired, a separate force resisting member for resisting generally horizontal movement of the foot support. In preferred embodiments of the invention, the foot supports extend in a horizontal plane and remain in a horizontal plane during the entire exercise movement but are linked to the support member in a manner to permit exercise simulations as indicated above. The linkages between the support member and the foot supports may include four bar or parallelogram linkages. In another preferred embodiment, a pair of horizontal support rails serves to support vertically and guide horizontally a pair of shuttle cars disposed thereon. Foot supports are pivotally linked to the shuttle cars. A force resistance means is connected between the foot support and each of the shuttle cars. In operation the foot supports may pivot with resistance with respect to the shuttle cars to produce a generally up and down motion similar to stair climbing. When a user stands on the foot supports, cross country skiing motion by such user is accommodated by reciprocating motion of the shuttle cars on the support rails. Simultaneous stair climbing and cross country skiing may be performed. BRIEF DESCRIPTION OF THE DRAWINGS The objects, advantages and features of the invention will become more apparent by reference to the drawings which are appended hereto and wherein like numerals indicate like elements and wherein an illustrative embodiment of the invention is shown, of which: FIG. 1 is a side elevation of an embodiment of the exercise device of this invention for a combined stair stepping exercise and a cross country skiing exercise in which a fluid cylinder resists up and down motion of foot supports in the climbing mode and acts as a link in the support between the frame and the supports to enable skiing motion. FIG. 2 is a plan view of the exercise device of FIG. 1 taken generally along the line 2--2 of FIG. 1; FIG. 3 is a side elevation of the exercise device similar to FIG. 1 but showing the foot supports moveable in a generally horizontal direction to simulate cross country ski motion; FIG. 4 is a front elevation of the exercise device shown in FIG. 3; FIG. 5 is a side elevation of an alternative embodiment of the exercise device of this invention in which fluid cylinders are provided for resisting the movement of the foot supports in a generally horizontal direction and for resisting the movements to foot supports in a generally vertical direction, with four bar linkages maintaining the foot supports in a generally horizontal plane; FIG. 6 is a side elevation of another alternative embodiment of the exercise device of the present invention utilizing servo motors for controlling the movement of the foot supports without the use of a fluid cylinder to produce foot support movement in a generally horizontal direction and in a generally vertical direction; FIG. 7 is a side elevation of another alternative embodiment of the exercise device of this invention similar to the embodiment of FIG. 6 but eliminating certain four bar links while utilizing fluid cylinders for resisting the horizontal and vertical movements of the foot support and having a fluid cylinder connected to the foot support for maintaining the foot support in a generally horizontal plane; FIGS. 8-13 are schematic views of other various embodiments of the exercise device of this invention in which foot supports are mounted for movement in a generally vertical direction for a stair stepping exercise and for simultaneous or single movement in a generally horizontal direction for a cross country ski exercise. FIG. 14 is a detailed illustration of an alternative low profile embodiment of the invention; and FIG. 15 illustrates an alternative embodiment for connection of handles to the exercise device for a stair climbing exercise. DESCRIPTION OF THE INVENTION Referring now to the drawings showing the embodiment of FIGS. 1-4, the exercise device generally indicated at 10 has a fixed support frame indicated generally at 12. Fixed support frame 12 includes a base support member 14 having end frame members 16 connected thereto and adapted for support by a floor. Upwardly extending frame member 18 supports an upper mounting head generally indicated at 20. Mounting head 20 includes a pair of opposed plates or side support members 22. A control panel 24 is provided between support members 22 for visually displaying performance data and the like as may be desired. Linkage support frames 26 and 28 are pivotally supported from opposed side support members 22. Frames 26 and 28 include multiple pivoted links. Linkage support frame 26 includes a pivoted foot support 30. Linkage support frame 28 includes a pivoted foot support 32. The foot support 30 supports the left foot of a user; foot support 32 supports the right foot of a user. Linkage support frames 26 and 28 are both shown in FIGS. 1-4, but only support frame 26 is described in detail, because support frame 28 is generally identical to support frame 26. Linkage support frame 26 includes a lower connecting plate or bracket 34. A four bar or parallelogram linkage generally indicated at 36 extends in a generally vertical direction between side support member 22 and connecting plate 34. Linkage 36 includes a pair of links 38A, 38B pivotally mounted at 40 to side support member 22 at their upper ends and pivotally connected at 42 to connecting plate 34 at their lower ends. A four bar or parallelogram linkage 44 extends in a generally horizontal direction between connecting plate 34 and foot support 30. The four bar linkage 44 includes a pair of links 46A, 46B pivotally connected at 48 to connecting plate 34 and pivotally connected at 50 to foot support 30. Downward movement of foot support 30 is resisted by fluid cylinder 52 which is pivotally mounted at its lower end at 54 to upper link 46A of linkage 44 and pivotally mounted at its upper end at 56 to side support member 20. Fluid cylinder 52 cushions the downward movement of foot support 30 from the weight of the user thereon. Cylinder 52 is preferably a combined damping mechanism and spring. Upon release of the weight of the user the spring of cylinder 52 returns foot support 30 to its upper position. The spring loading may be manually adjusted for determining in the return movement. The resistance to the downward motion of foot support 30 from fluid cylinder 52 increases with downward velocity due to the damping mechanism of cylinder 52. Operation in the stair climbing mode FIG. 1 illustrates the condition of the exercise machine 10 in the stair climbing mode where the left foot of a user has pushed foot support 30 to a downward position. Natural action of the user takes force off of foot support 32 and it rises to the position shown under the upward spring force of a right hand side fluid cylinder 52. For a solely stair stepping exercise, a user may wish to support himself by holding on to support plates 22 or to an auxiliary stationary bar (not shown) arranged for safety and stability during such exercise. Such bar may be fastened to base support member 14. At the lower position shown for foot support 30, the fluid cylinder 52 completely "strokes out" such that fluid cylinder acts as a pivoted link between top support plate 22 and link 46A of linkage 44. Accordingly, in order to shift into a purely skiing exercise, the user stands on both foot supports 30 and 32 such that both of their fluid cylinders completely "stroke out" and the machine 10 is ready for horizontal skiing exercise. Handles for skiing exercise Left and right handles 60 are provided with upper hand grips 62 to aid a user when the machine is used in the skiing mode. FIGS. 1, 3 and 4 illustrate the preferred design of attaching handles to the outer link 38A of four bar linkage 36. Handles 60 may be fixed to link 38A by welding or other means such as screws or nuts and bolts. If desired, a force resisting means such as a spring and damper cylinder 100 may be placed between handle 60 and frame member 18 to resist backward and forward motion of the foot supports 30, 32. (Other force resisting means useful in the exercise machine art may be substituted for cylinder 100.) Such force resisting means 100 may not be needed in that the very act of a user shifting his weight in a forward and backward motion may offer sufficient exercise to not require further force resisting means. For that reason, fluid cylinder 100 is shown in dashed lines to indicate that it may be installed when desired, or alternatively that it might not be necessary for proper skiing simulation. Of course, another fluid cylinder 100 (or other force resisting means) should be installed on the right-hand side between link 38A and frame member 18. Either the skiing mode or the stepping mode may have a mechanism to provide dependent operation between the left and right foot supports. Such mechanism may include a cable and pulley arrangement connected between the right and left linkages which causes the left foot support to move upwardly when the right foot support is forced downwardly and vice versa. A similar mechanism may be provided for forward and backward movement of the foot supports. Design of linkages to allow horizontal movement of foot supports As best illustrated in FIG. 3, foot supports 30 and 32 may be moved in substantially horizontal forward and rearward direction while being suspended from mounting head 20 by linkage 26. In such skiing mode, the fluid cylinders are completely "stroked out" and serve as an intermediate link between mounting head 20 and arm 46A of link 44. The linkage 36 is a four bar pivoted linkage between head 20 and connecting plate 34. The linkage 44 is a four bar pivoted linkage between connecting plate 34 and foot support 30. (The right-hand side has similar linkages to foot support 32). The stroked out cylinder 52 forms a pivoted linkage between mounting head 20 and linkage 44. Such stroked out cylinder 52 forms still a third four bar linkage with head 20 and links 36 and 44. By appropriate adjustment of the lengths of links 36, 44 and stroked out cylinder 52 and by appropriate connection placement of cylinder 52 at head 20 and link 46A, the foot supports 30 and 32 may be constrained to move in a substantially horizontal backward and forward position, all the while being suspended from head 20 and requiring no connection on a track or the like. Operation in the skiing mode A user stands on both foot supports 30 and 32 to completely stroke out the fluid cylinders 52. The user then begins a shuffling skiing type motion while holding left and right handles 62. (Such motion is also similar to skating.) As the left hand foot support 30 moves forward, the left handle 62 moves rearward and up because of its connection to link 38A. As the left hand foot support 30 moves rearward, the left handle 62 moves forward and down. Such handles simulate the motion of ski poles manipulated by an actual skier. Operation in multiple modes The exercise machine 10 of FIGS. 1-4 may be operated in a mixed mode so that a combination of stair stepping and skiing motion may be simulated. In a forward direction, running, walking, or cycling type motions may be simulated. Such running motion is simulated (similar to that of a treadmill) without any impact at all on the user's knees, hips or feet. Reverse running motion may also be simulated. Alternative embodiments Referring to FIG. 5, an alternative exercise device indicated at 10A is shown schematically with linkage support 26A including an upper four bar linkage 36A and a lower four bar linkage 44A. (Only the left-hand side of the exercise device is illustrated. A similar right-hand side of the machine is provided, but it is not illustrated here, for simplicity.) A foot support 30A is mounted on one end of four bar linkage 44A. Resistance to movement of foot support 30A in a generally vertical direction is provided by a fluid cylinder 52A connected between lower four bar linkage 44A and upper four bar linkage 36A. Resistance to generally horizontal movement of foot support 30A may be provided (if desired) by fluid cylinder 53A extending between four bar linkage 36A and upright frame member 18A. An abdominal pad 21A is secured to fixed support frame member 18A to support the abdomen of a user. A control box 24A is mounted on the upper end of fixed support frame member 18A to provide to the user a visual observation of his performance from sensors (not shown) mounted on the machine. No manually operated handles are provided in the embodiment of FIG. 5, although such handles, similar to those of FIGS. 1-4 could be provided if desired. Another embodiment of the exercise device of this invention is illustrated at 10B of FIG. 6. It is similar to the exercise device 10A of FIG. 5 except in regard to the force resisting members resisting the vertical and horizontal movements of foot support 30B. Four bar linkages 36B and 44B are provided. A connecting plate 34B includes a pivot 42B for linkages 36B and 44B. Pivot 40B is provided for four bar linkage 36B mounted on fixed vertical support frame member 18B. A servo motor 43B is provided to control the pivotal movement of pivot axis 42B. Another servo motor 45B is provided to control the pivotal motion of pivot 40B. Thus, servo motor 43B may be used to provide a resisted force to the generally vertical movement of foot support 30B. Servo motor 45B may be used to resist the generally horizontal movement of foot support 30B. Servo motors 43B and 45B may be adjusted to provide the desired resistance. Alternatively, servo motors may provide a programmed motion, either stair climbing or skiing or any combination of both motions for physical rehabilitation of a patient. Referring now to FIG. 7, an exercise device of for this invention is shown at 10C. Linkage support frame 26C includes an upper link 38C and a lower link 46C. An upper fluid cylinder 53C extends between link 38C and fixed support frame member 18C to control the horizontal movement of foot support 30C. Fluid cylinder 52C controls the generally vertical movement of foot support 30C and is connected between links 38C and 46C. To maintain foot support 30C in a generally horizontal plane, fluid cylinder 55C is pivotally mounted between link 46C and foot support 30C. The providing of a separate fluid cylinder 55C to maintain foot support 30C in a generally horizontal plane eliminates the necessity of having four bar linkages as in the embodiments shown in FIGS. 1-4, FIG. 5, and FIG. 6. Other satisfactory force resisting devices could be provided such as servo motors, for example. FIGS. 8-13 are schematic views of further embodiments of the exercise device in accordance with the present invention in which foot supports 32 (D,E,F,G,H,I) are moveable simultaneously in a stair stepping exercise and in a cross country skiing exercise with a force resisting device for resisting generally vertical movement for the stair stepping exercise and a separate force resisting device for resisting generally horizontal movement for the cross country skiing exercise. For example, as shown in FIG. 8, exercise device 10D has foot supports 30D and 32D mounted for sliding movement on links 46D which are pivotally mounted at 48D to fixed frame member 18D. To resist generally horizontal movement of foot supports 30D and 32D, force resisting devices 53D may be provided if desired. To resist generally vertical movement of foot supports 30D and 32D, force resisting devices 52D are provided. Such force resisting devices are similar to those of FIGS. 1-4. The exercise machines of FIGS. 9-13 are not shown with force resisting devices of members thereon. However, it should be understood that force resisting devices similar to those in the embodiment of FIG. 8 would be used for the embodiments of FIGS. 9-13. Referring to FIG. 9, foot supports 30E and 32E are mounted on link arms 46E which, in turn, are pivotally mounted at 48E to carriages 49E which are mounted for horizontal movement along fixed base frame member 14E. FIG. 10 shows an embodiment in which foot supports 30F and 32F are mounted for sliding movement along link arms 46F which, in turn, are pivotally mounted at 48F to base frame member 14F. FIG. 11 shows an alternative preferred embodiment 10G of the invention having foot supports 30G and 32G mounted on four bar linkages 36G which, in turn, are pivotally mounted on a shuttle car or carriage 49G for horizontal movement along base frame member 14G. A more detailed description of the embodiment of FIG. 11 is described below in conjunction with FIG. 14. FIG. 12 shows exercise device 10H having foot supports 30H and 32H mounted for sliding movement along an upper link 46H of a four bar linkage which is pivotally connected by rear and forward pivots at 48H to a base support member 14H. FIG. 13 shows an embodiment 10I in which foot supports 30I and 32I are mounted on links 46I which are pivotally connected at 42I to links 38I. Links 38I are pivotally connected at 40I to fixed vertical support frame member 18I. Alternative low profile embodiment of the invention FIG. 14 shows in more detail an alternative preferred embodiment of the invention in which a pair of rails 14G vertically support and horizontally guide a pair of foot supports 30G. In the view of FIG. 14, only one support is shown in its up and down positions, but an identical foot support and rail is placed on the other side of the ones shown. Rollers 33G are secured to shuttle cars 49G and fit within a guide groove of rails 49G. Brackets 41G are secured between foot supports 30G and shuttle car 49G. Accordingly, when a user stands on foot supports 30G and alternately moves his legs in forward and backward directions, shuttle carriage 49G moves forward and backward as it is guided by rollers 33G within guide grooves of rails 14G. Links 36G are connected by pivots 37G to bracket 41G and by pivots 39G to the forward end of shuttle car 49G. Links 36G are preferably parallel to each other so as to create a four bar linkage between the foot supports 30G and the shuttle cars 49G. A damper 35G is connected between bracket 41G at one of the pivots 37G to another pivot 43G on shuttle car 49G. Such damper increasingly resists downward motion as a function of increasing downward velocity. Such dampers may be adjustable to provide variable resistance. The damper 35G may also include a spring to bring foot support 30G to an upward position when the user is not standing on it. The damper and the spring may be separate items, but preferably they are in an integral "shock absorber" as illustrated in FIG. 14. Alternatively, a spring return may not be desired for independent action of each foot support 30G; in that case, left and right foot supports are interconnected by means of a pulley arrangement or the like such that as the left foot support is forced downwardly, the right foot support moves upwardly and vice versa. The alternative preferred embodiment of FIGS. 11 and 14 allows the same simultaneous stair climbing and cross country skiing exercises as that shown in the embodiment of FIGS. 1-4. It has the advantage of a lower vertical profile, especially where support 180G may be folded down; with the result that the exercise device may be stored in less vertical space. Alternative arrangement for poles for stepping exercise FIG. 15 illustrates an alternative embodiment of the invention of an exercise device 10J similar in arrangement to that of FIGS. 1-4, but with an alternative connection of poles 60J to the linkage 36J which links foot supports 30J and 32J to support 20. The left hand pole 60J is connected by a pivot 84F to bracket 82 fastened to link 38BJ. Pole 60J includes a bar 86J secured for motion within slot 90J of bracket 80J which is pivoted to connecting plate 34. The right hand handle 60J is connected (the connection is not shown) in a corresponding way to link 38BJ on the right hand side of the exercise device 10J. The alternative arrangement of poles 60J and their connections to links 38BJ enable them to move rearwardly when its associated foot support moves up and vice versa. With reference to FIG. 15, as support 30J moves up, link 46AJ pivots upwardly about pivot 42J causing bracket 80J to pivot counterclockwise. Such rotation of bracket 80J causes pole 60J to rotate clockwise about pivot 84J in bracket 82 while the end of pole 60J slides downwardly with its link 86J in slot 90J. Opposite motions occur when the foot support moves downwardly. The arrangement of the handles of FIG. 15 causes them to move in a sympathetic manner with the natural movement of human arms when climbing stairs. In other words, as a user's left foot pushes downwardly his left arm naturally rises and vice versa. While preferred embodiments of the present invention have been illustrated in detail, it is apparent that modifications and adaptations of the preferred embodiment will occur to those skilled in the art. For example, although several embodiments of the invention have been illustrated it should be apparent to routineers in the art of exercise equipment design that other support structures than the floor support members of FIGS. 1-6 are possible. A wall support or even a support from an overhead structure could be used with the foot supports and linkages of the invention. It is to be expressly understood that such modifications and adaptations are within the spirit and scope of the present invention as set forth in the following claims.

1a

BACKGROUND AND SUMMARY OF THE INVENTION Exposing one's eyes to high amounts of ionizing radiation is fairly common in various trades and industries. It is especially true in the medical profession, particularly with doctors who specialize in fluoroscopic procedures including cardiac catherization. An article written by Dr. H. D. Maillie and W. D. Gregory, both of the University of Rochester School of Medicine and Dentistry, appearing in the August 1973 issue of RADIOLOGY magazine particularly points out this problem. On page 463 the authors describe the average exposure to the eyes of cardiologists. It is also noted that, because of this exposure, they can perform only a limited number of catherizations per week. A more detailed description of this problem follows in the article. A table of findings from a controlled experiment is included on page 465. The tone on page 465 seems to indicate that the yearly exposure of cardiologists is higher than that which is recommended by the National Academy of Sciences Advisory Committee on the Biological Effects of Ionizing Radiation (the Beir Committee). In summing up, the authors states, "It is felt that, until it can be established that a high threshold does exist for the radiation production of lens opacities in man, steps should be taken to prevent exposures to the eyes in excess of MPD (Maximum Permissible Dose Ionizing Radiation)." However, the authors of this article do not describe or recommend any steps or procedures which will protect the eyes from radiation. U.S. Pat. Nos. 1,191,274 and 3,030,628 teach protective face masks and anti-ray eye shields, but neither of these patents discloses an ionizing radiation eye shield of the type described and claimed in the present patent application. It is, therefore, the principal object of the invention to provide a novel radiation eye shield. Another object of the invention is to provide a fluoroscopic eye shield which protects a fluoroscopist from the hazards of a direct x-ray beam or the scattered radiation emanating from the patient's body. Yet another object of the invention is to protect the user's eyes from every angle during cardiac catherization or other lengthy procedures involving fluoroscopy. It is a further object of the invention to provide a radiation eye shield of lightweight construction and one which remains firmly and comfortably in place during use, even if the user wears glasses. In particular, the present invention includes a pair of radiation-attenuating goggles of a high density material or one having extra peripheral shielding around the pair of lead-glass lenses. In one example, the housing or frame supporting the lenses suitably comprises the means of support for the additional shielding. However, this extra protective radiation shielding which surrounds the front and side surfaces of the goggles, may also preferably shield the eyes as well from above and below and may actually comprise the same high density material used for the lenses. The above and other ojects of the present invention will become apparent upon reading the following specification and referring to the accompanying drawing, which forms a material part of this disclosure. The invention accordingly consists in the features of construction, combinations of elements, and arrangements of parts which will be exemplified in the construction hereinafter described and of which the scope will be indicated by the appended claims. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a top view of the radiation or fluorscopic eye shield of the present invention; FIG. 2 is a sectional view of the invention, taken along the line 2--2 of FIG. 1; FIG. 3 is a sectional view of the invention, taken along the line 3--3 of FIG. 1; FIG. 4 is a perspective view of the extra shielding, taken from the top and side, without the goggles present; FIG. 5 is a perspective view of a modified radiation eye shield, wherein the front portion is a large viewing window and the remainder portion is the housing supporing same; and FIGS. 6 and 7 are perspective views of a fluoroscopist, respectively, showing him with and without the goggles and a dramatization of the ionizing radiation impinging upon his eyes, during ordinary fluoroscopic procedures. DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention in its broadest application, therefore, comprises frame means or a housing in the form or shape of goggles having lead-glass lenses or a single large lens and wherein the frame means or housing forming the overall goggles comprises a high density material for shielding the eyes from radiation, whether scattered or from a direct beam. Thus, the basic invention may simply comprise a frame means or, preferably, housing in the form and shape of a conventional pair of goggles wherein the material forming same is simply lead, and wherein the lenses are made of a clear or transparent lead-glass material. Other suitable high density materials may be used in lieu of lead, such as tantalum, tungsten, or the like. As will be explained hereinafter in greater detail, the preferred embodiment of the invention incorporates suitable frame means or a housing supporting the lead-glass lenses or lens, wherein the frame means or housing is preferably made from a lead-vinyl material. Such material may comprise a vinyl impregnated with lead or a foam-like vinyl material containing lead, or even a laminate of lead and vinyl or other suitable material possessing effective shielding qualities, as is conventionally well known in the art. In the drawing, and referring more particularly to FIGS. 1-4, a radiation eye shield is generally designated by the reference character 10, and comprises a suitable frame means or housing 12 having an adjustable, preferably elastic headband 14 attached to the side portions or panels 16. The headband 14 being elastic or otherwise suitably adjustable is used to accommodate the fit of the eye shield or goggles 10 on one's head. The ends of the headband 14 may be fixedly secured to the goggles 10 or may pass through a pair of suitable elongated apertures 15 (only one shown) on each side of the goggles 10 to provide even greater adjustment to the length of the headband 14. The interior edge or front portion 18 of the goggles 10 is contoured and made to fit comfortably against one's face. The top portion 20 of the goggles 10 should preferably have suitable ventilating means, such as the ventilation holes 22 to prevent fogging of the lenses 24 and to permit circulation of the ambient air. In the particular embodiment of FIGS. 1-4, the eye shield or goggles 10 are equipped with a radiation protective shield 26 of one or more pieces secured in any suitable manner to the goggles 10, such as by means of adhesives, fasteners and the like, to the inner front, side, bottom and even top surfaces of the goggles 10. The front portion 28 of the shield 26 is, of course, provided with suitable cutouts for the eye lenses 24 and for permitting the nose to protrude from the goggles 10. A top portion of the shield 26, although not shown for purposes of convenience, may extend entirely across the roof of the shield 26, as best shown in FIG. 4, and same would also be provided with ventilation holes coincident with those in the top portion of the goggles 10. This top portion is useful for protecting the user from scattered radiation from the patient and table, particularly from scattered radiation reflected from the ceiling and x-ray machine fixtures disposed above and about the user. As noted hereinbefore, the shield 26 may comprise the actual goggles 10 or it can be made of any suitable high density radiation protective material. The shield 26 may thus be of lead or any other radiation protective metal. The shield 26 should preferably be made of a soft flexible material, and suitably impregnated with a high density material. Such a soft flexible material is "warm to the touch" and is more comfortable to one's face, in comparison to a metal sheet material which is cold to the touch. The preferred material for the goggles 10 itself or for the shield 26 when the goggles 10 are made of another material, such as plastic, is a lead-vinyl composite with the previously mentioned qualities. Although lead rubber may also be used in lieu thereof, this lead impregnated vinyl material is preferred inasmuch as it is 10% lighter in weight than lead rubber. Lead-impregnated vinyl has a sanitary, non-absorbing, smooth surface on both sides and it also has an indefinite shelf life, as the material does not age. Further qualities and properties are its uniform density, flexibility and pliability. It is also acid and alkali resistant, odorless, and exhibits considerable abrasion resistance. The preferred thickness of shielding may vary over a wide range dependent upon the degree of shielding required. An example of a desired material is Lead X (manufactured by the Bar Ray Company of Brooklyn, N.Y., and Lead X is its trademark). The goggles 10 have two apertures 27 in the front 28 thereof and extending outwardly therefrom are suitable lens housings 30, for removably replacing the lenses 24, as may be necessary if they break or otherwise are damaged during use, for instance if the goggles 10 are dropped. The housings 30 are suitably provided with external threads, and cover means 32 having compatible internal threads together hold the removable lenses 24 in place. Of course, the lenses 24 may be permanently affixed to the goggles 10, if desired. For example, if desired they may be secured directly to the shield 26 itself or to the front portion 28. Although the lens 24 may be made from any transparent radiation protective material, it is preferred to employ a transparent lead-glass material for the lens. If desired, the two lenses 24 may be replaced by a single elongated or wide lens (not shown) forming a large window-like structure with which to look and observe through. Such a structure would provide greater peripheral vision than that of a pair of lenses. Also, these lenses may be angulated and joined at the center by a flexible bond such that they bridge the nose. The lens structure may also be comprised of a composite of lenses completely abridging the eyes and temples to provide further peripheral vision. Such a structure is shown in FIG. 5, where the shield itself is the housing or goggle means, and the front panel is a single large lens, and the radiation eye shield or actual goggles 40 themselves form the extra radiation shielding in these alternate constructions where the material forming the goggles is of high density. For example, the goggles 40 of FIG. 5 may comprise elements of lead-glass fixedly held together by conventional adhering means or other securing means, or the goggles could be made in one piece, although it would be expensive to do so. FIGS. 6 and 7 illustrate a fluoroscopist 42 conducting fluoroscopic procedures on a patient 44. The x-ray tube or device emitting x-rays 46 is below the patient and an image amplifier 48 is disposed above the patient. A TV monitor 50 may be mounted on a wall or on a cart and the arrows are representative of the ionized rays scattered about the patient and fluoroscopist during such procedures. Note that both direct and scattered rays can penetrate one's eyes, and the goggles or eye shield 10 of the present invention, as shown in FIG. 6, clearly protects the eyes from every angle, not just from rays directly impinging eyes shielded by simple lead-glass lenses alone. While the invention has been described, disclosed, illustrated and shown in terms of an embodiment or modification which it has assumed in practice, the scope of the invention should not be deemed to be limited by the precise embodiment or modification herein described, disclosed, illustrated or shown, such other embodiments or modifications as may be suggested to those having the benefit of the teachings herein being intended to be reserved especially as they fall within the scope and breadth of the claims here appended.

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This invention relates to foodstuffs for suppressing hunger and particularly soft drinks formulated to high total titratable acidity effective to suppress hunger when ingested prior to a meal. BRIEF DESCRIPTION OF THE PRIOR ART Soft drinks of all varieties are well known. They are prepared from still or carbonated water either at home or bottled for sale in the retail trade. The beverages are composed of water, sweetening agents, acid flavor, color and optionally buffering agents and preservatives. Many contain clouding systems designed to replicate natural beverages particularly fruit beverages. The sweetener, acid and carbon dioxide ratios vary with the type of beverage flavor. FDA approved food colors are often used. Flavors are available from suppliers and can be alcohol extracts of ginger, grape and certain lemon-lime flavors. Emulsion of essential oils are available for citrus flavors, as well as root beer and cola. Caffeine is often added for bitterness. Fruit juice is widely used to manufacture orange, grapefruit, lemon, grape and lime beverages. Sodium citrate is sometimes employed as a buffering agent. Acidulents are widely used with citric acid, phosphoric acid, malic acid and tartaric acid most commonly used in carbonated beverages. These acids are usually employed at up to 0.12% by weight in ginger ale and lemon-lime and orange beverages and lower amounts in root beer and cola. Higher amounts are used in lemonade and grapefruit. See Kirk-Othmer, Encyclopedia of Chemical Technology, Vol. 4, pp 710-725 by John Wiley & Sons, New York, N.Y. (1978). Numerous patents have disclosed sweetening compositions for beverages and beverages of reduced calories or of improved nutritional value. U.S. Pat. No. 3,647,483, to Eisenstadt, teaches a saccharine sweetening composition comprising saccharine, with glucono-delta-lactone, sodium and/or potassium gluconate and cream of tartar used to avoid the bitter aftertaste of saccharine. The composition is not an acidic beverage and if employed in a beverage would not give the acid content required by the present invention. U.S. Pat. No. 3,946,121, to Eisenstadt, discloses a sweetener consisting of saccharin, glucono-delta-lactone and an edible bicarbonate. Both Eisenstadt sweetener compositions are intended to sweeten coffee, tea and conventional beverages. U.S. Pat. No. 3,619,205, to Le Van, et al., discloses a slush iced beverage of still or carbonated water. Equal portions of the spoonable slush are mixed with water to form the beverage. Hawley, The Condensed Chemical Dictionary, 10th edition, pp. 500, 501, teach glucono-delta-lactone and gluconic acid. Winter, A Consumer's Dictionary of Food Additives, p. 115, Crown Publishers, Inc., New York, NY, teach glucono-delta-lactone is an acid used as a leavening agent, and in jelly and soft drinks where a dry food acid is desired. Tsai, et al., U.S. Pat. No. 4,946,701, teaches fruit juice, tea and coffee beverages. U.S. Pat. No. 3,846,560, to Hempenius, et al., relates to a process for the preparation of an acidified beverage rich in solubilized polypeptide. U.S. Pat. No. 4,010,285, to Van Doren Jr., discloses an improved aqueous base soft drink concentrate formulation, and more particularly to a formulation which is particularly adapted for retention of carbon dioxide. The flavor concentrate can include sodium citrate, sodium gluconate and glucono-delta-lactone. U.S. Pat. No. 4,015,023 to Lamberti, et al., relates to the use of certain substituted succinic acid compounds as food additives. U.S. Pat. No. 4,042,684, to Kahm, relates to a dietetic beverage for supplementing the requirements of sugar and essential salts in a mammalian body and, more especially, to those requirements in a human body where such components have been depleted through vigorous physical activity. The dietetic composition comprises: ______________________________________Fructose 0.4-0.7%Glucose 1.6-2.8%Sodium Chloride 0.16-0.33%Potassium Chloride 0.03-0.13%Free Citric Acid 0.026-0.26% balance______________________________________ U.S. Pat. No. 4,200,662, to Scibelli, relates to turbid protein fortified acidic soft drinks which have a stable suspension of particles therein. U.S. Pat. No. 4,478,855, to Dahlen, et. al., relates to a fruit juice drink. U.S. Pat. No. 4,497,800, to Larson, et al., discloses a nutritionally complete liquid diet composition formulated to give a stabilized ready-to-use liquid product useful in providing for patients with compromised digestive function. U.S. Pat. No. 4,690,827, to Kupper, et al., relates to a beverage which comprises fruit juice, water and a non-nutritive sweetener, characterized in that it has a background pulp level which is at least 20%, preferably at least 70%, greater than the background pulp level that would be obtained by low shear mixing of the ingredients. U.S. Pat. No. 4,834,990, to Amer, relates to improved non-dairy liquid food products such as fruit juices or drinks or other non-dairy liquids containing significant amounts of dietary fiber and desirable calcium. U.S. Pat. No. 4,871,571, to Jensen, et al., relates to a low calorie bulking agent and to the employment of a beta glucan hydrolysate as a substitute for sucrose, glucose and the like in a dietetic beverage. None of the prior art references suggest that human satiety could be achieved by upward adjustments of the acid content of a beverage. SUMMARY OF THE INVENTION We have discovered a unique method of producing satiety by increasing the titratable acidity of a foodstuff particularly beverages. The beverage is prepared using a unique combination of common food ingredients, is palatable, satiating, and low calorie. When consumed before meals the beverage has been shown to decrease subsequent meal intake. The beverage is prepared using a high concentration of edible acid of up to 5 to 20 times greater than normally employed in beverages and at least fifty percent greater than the titratable acidity of still lemonade or carbonated lemonade. The high acid content lowering effect on pH is buffered using high levels of metal salts of the same acids to maintain a pH of 2.5-4.0. An intensive sweetener is used to further reduce calorie content. We have found at least a 10% reduction in food intake resulting from ingesting the foodstuff shortly before a meal. DETAILED DESCRIPTION OF THE INVENTION We have developed good tasting foodstuffs particularly diet soft drinks which do not rely on drugs to result in decreased food consumption and do not replace calories with inert materials. We have surprisingly found that a conventionally tasting soft drink can be made by increasing the acid content of a beverage to raise the total titratable acidity (TA) of the beverage to at least about 125 TA and preferably about 150 TA. This is accomplished by a blend of common acids and preferably with the use of glucono-delta-lactone. ##EQU1## Where 11.9826 is the conversion factor from lbs/gallon to gram/ml. ##EQU2## Other components such as carbonation, sweetener, caramel, color and flavor may contribute to the total acidity in a minimal way. We have found that the use of glucono-delta-lactone helps us balance flavor and produces a better tasting beverage. We particularly prefer to employ the glucono-delta-lactone with an organic acid and phosphoric acid and often in roughly equal TA portions of one to two parts of each of organic and phosphoric acid TA contribution to each one part glucono-delta-lactone TA contribution. The glucono-delta-lactone has a low sourness and produces a beverage less tart and sour at low pH than a beverage using other inorganic acidulents. We have also found it necessary to buffer our very acid food stuff with metal salts of the same acids employed for acidulation. We have found common citrates and phosphates to be highly effective in maintaining the beverage pH above 2.5, preferably 2.5-4.0 and most preferably pH 2.5-3.5. We employ organic and inorganic acids such as citric, phosphoric, glucono-delta-lactone, gluconic, malic, tartaric, fumaric, adipic and mixtures thereof. We prefer to employ a major amount of citric, phosphoric and the glucono-delta-lactone usually 60%, preferably 75% or more of the acid content of the food stuff. Our food stuff usually contains on a dry weight basis from 5-40% citric acid, preferably 10-25% and from 20-60% glucono-delta-lactone, preferably at least 30% and more preferably 35-55% of the foodstuff. The total acidic materials are employed at about 50-90%, preferably 60-80% and most preferably 65-80% of the foodstuff. We employ buffers to maintain a pH of 2.5-6.0, preferably pH 2.5-4.0 and most preferably pH 2.5-3.5. We have found that the metal salts of the common acids such as sodium or potassium citrate, disodium or dipotassium phosphate and the like work very well to elevate the low pH caused by the high titratable acidity. We employ buffers from 10-40%, more preferably in excess of 15% and most preferably from 15-35% of the food stuff. An intensive sweetener which is food approved is employed such as one selected from the group of "aspartame", "sucralose", "acetosulfam", "saccharine", "cyclamate" or others of equivalent sweetness and mixtures thereof. The type of sweetener is not critical to our invention so long as it is stable in the food for the period of its use. However, we prefer to prepare reduced calorie foods and to use an intensive sweetener exclusively. The intensive sweetener is normally used up to 5%, preferably 0.1-4% of the food stuff depending upon its intensity. In preparing syrups for beverages, we employ from 1-3% citric acid or combinations of organic acids, 1.5-2.5% phosphoric acid, 2.0-10% glucono-delta-lactone, from 1.0-4.5% acid buffering salts such as alkali metal citrates, mono and di alkali metal phosphates and sweeteners such as aspartame to taste. The good tasting, satiety producing beverage of this invention can be prepared from still water but is preferably carbonated. The beverage contains at least 0.15% and preferably 0.2% organic acid, preferably citric acid, at least 0.15% and preferably 0.7-1.5% and most preferably 0.85-1.25% glucono-delta-lactone, at least 0.25% acid buffering salt, preferably an alkali metal salt of the acids employed in this invention and most preferably at least 0.4% buffering salt. The beverage is usually prepared by dissolving the ingredients in water to form a syrup which is blended volumes of carbon dioxide in the final beverage. If desired, however, dry mixes can be prepared for dissolution in water by the consumer or in preparing bottled still beverages. Flavors, fruit juice, caffeine and other conventional ingredients may be used to formulate the final beverage. In preparing our beverage the total acid content of the beverage should be 0.7% or greater, preferably 0.75% to 1.5% of the beverage which is five to twenty times greater than in the equivalent non-satiety beverage. The buffer concentration is also high exceeding 0.4%, preferably 0.45% of the beverage to elevate and maintain the pH at 2.5 to 3.5. The invention is further exemplified by the following example: ______________________________________ExamplePink Grapefruit JuiceSyrup Formula lbs T.A.______________________________________Citric Acid 24.0 49.9Phosphoric Acid (80) 22.5 49.9Glucono-delta-lactone 66.9 50.0Potassium Citrate 26.0 --Dipotassium Phosphate 15.5 --Aspartame 3.75 traceTotal 158.65* 150.0Water to 150.00 gal______________________________________ *Throw = 1 part syrup plus 5 parts water 150 gal = 900 gallons of finished beverage Dissolve the previous listed ingredients in water sufficient to prepare 150 gallons of syrup. Dilute the syrup 5 to 1 with carbonated water and bottle to prepare 900 gallons of a final carbonated drink having the following characteristics: ______________________________________ most preferably preferablyCharacteristic greater than at least about______________________________________TA 110 125 150pH 2.0-6.0 2.5-4.0 2.5-3.5Sweetener to taste 457-525 ppmCO.sub.2 0-6.0 vol 1.0-5.0 vol. 2.5-3.5 vol______________________________________ When 16 oz of the above prepared beverage iS ingested by a small test panel of humans 20 minutes prior to a macaroni and beef meal, the amount of food eaten is reduced by 10-30% and yet the beverage tastes like a conventional diet soft drink. The 10-30% reduction in food intake has been replicated three times, two of which were statistically significant. While this invention is applicable to mono and disaccharide sweetened beverages including coffee and tea, it is most applicable to diet beverages sweetened with intensive sweeteners especially citrus flavored beverages. The invention is most applicable to normally high acid citrus beverages such as grapefruit drinks and lemonade. Unless otherwise indicated, all percentages are by weight.

1a

PRIORITY CLAIM [0001] The present application is a National Phase entry of PCT Application No. PCT/EP2010/002968, filed May 14, 2010, which claims priority from German Application No 102009021604.9, filed May 15, 2009, the disclosures of which are hereby incorporated by reference herein in their entirety. FIELD OF THE INVENTION [0002] The invention relates to a method for marking of coagulation sites on a retina by means of a light source as well as a system for coagulating the retina for executing such a method. BACKGROUND [0003] The use of focused light from an axial high-pressure lamp for the treatment of various diseases of the retina, e.g., diabetic retinopathy, by means of the light coagulation has been known for decades. Nowadays, the retina is warmed up or coagulated during light coagulation by means of a laser beam, wherein the energy of the laser beam is absorbed by the dark coloring of the pigment epithelium within the retina. As a result, the metabolism is focused on the as yet healthy areas of the retina. In addition, biochemical cofactors are stimulated. This way, the progress of the disease is considerably slowed or stopped. [0004] However, it is hereby disadvantageous that tissue worthy of preservation, particularly the photoreceptor layer located in beam direction in front of the retinal pigment epithelium, is also destroyed. Therefore, solutions have been provided which minimize the destruction of tissue worthy of preservation, wherein the local treatment is terminated once a defined temperature is reached at the coagulation point. Hereby, a temperature-controlled coagulation system with a continuous coagulation laser and a pulsed measuring laser as well as a detector, a control device, and an interrupter is used. Thereby, the coagulation laser is designed is such a way that a coagulation beam is emitted and that the measuring laser generates a temperature-dependent measurement signal for the detector in the target area of the coagulation laser. Thereby, the detector exhibits a temperature sensor that detects a signal which allows for conclusions regarding the temperature at the coagulation point. The signal detected by the detector is transmitted to the control device which activates the interrupter once a predetermined temperature is reached, thereby interrupting the beam of the coagulation laser. [0005] The coagulation points are periodically adjusted manually by the operator who individually triggers the coagulation beam. This is very time-consuming and the success of the treatment greatly depends on the abilities of the operator; therefore, it was suggested in WO 2007/035855 A2, e.g., to provide a system and a method, wherein a pattern of coagulation points is provided from which the operator can choose beforehand and/or combine the various patterns with one another. Thereby, two-dimensional arrangements of coagulation points are considered patterns which, for example, exhibit a matrix of 2×2, 3×3, 4×4, 5×5, etc., wherein the distances of adjacent coagulation points remain constant. This prior art also provides other two-dimensional patterns, e.g., arrangements on a circle and/or on concentric circles, elliptical and sector-shaped arrangements. [0006] However, such fixed patterns of regular geometry are disadvantageous because very often they do not correspond to the morphological conditions of the physiological anomalies. Therefore, recoagulation with a second or third coagulation pattern up to a single-burst coagulation, which was to be overcome with said method, is frequently required for efficiently executing a completely effective panretinal photocoagulation. Even though it is possible with the above-mentioned prior art to achieve a large pattern which leads to an increase in the speed of the treatment, the risk of overcoagulation and/or undercoagulation through the changeable focus remains due to the retinal curvature and/or varying absorption behavior of the present ocular media. SUMMARY OF THE INVENTION [0007] Therefore, the problem addressed by the invention is that of allowing for a laser treatment, for example retina coagulation, laser trabeculoplasty, or an optimized panretinal photocoagulation, at very high treatment speed, wherein only pathological areas but no healthy areas are coagulated. Thereto, the marking of coagulation sites, visible to the operator before the treatment, by means of a method shall be ensured, and a system for coagulation shall be provided which allows for the execution of such marking. [0008] This problem is solved through a method for marking of coagulations sites on a retina by means of a light source with the features discussed herein. Projecting a serial spot sequence of the light source from a sequential, one-dimensional series of individual spots on the retina by means of a beam deflection unit, wherein the individual spots indicate the coagulation sites. This indicates to the operator beforehand, i.e., before the actual coagulation takes place, on which sites the coagulation is to occur. Waiting for confirmation of the sequence of individual spots by means of entry of a confirmation signal ensures that no coagulation sites are treated which are to be spared, e.g., because they contain healthy tissue. After confirming the sequence of the individual spots, according to the invention, an automated sequence of steps having a further serial spot sequence and projection of the same on the retina is recalculated. The use of a sequential, one-dimensional series of individual spots, which are created automatically, leads, when compared to a manual determination of said individual spots, to a significant increase in speed. Contrary to the provision of very complex two-dimensional and large patterns, the method, according to the invention, is advantageous because a confirmation must be entered by the operator for every individual sequential, one-dimensional series in order to subsequently—this not being subject matter of the method according to the invention—execute the coagulation on said sites. As a result, coagulation of healthy tissue is avoided and only those coagulation sites are accepted which are actually necessary for the healing process. Through the repetition of the above-mentioned steps according to the invention, it is possible to mark a large area of the retina with coagulation points in a short period of time. [0009] In an advantageous development of the invention, the sequential, one-dimensional series of individual spots exhibits equidistant distances and the progression of which is straight or curved as well as continuous or non-continuous. Due to the different indicated possibilities of placing the individual spots, the conditions in respect of the pathological areas of the retina as well as the present ocular media, such as astigmatism or other types of defective vision of the eye to be treated can be taken into account. [0010] A further advantageous development of the invention provides for the temporal series of the spot sequence to have an interval between spots according to one example 1 ns and 5 s, preferably between 1 μs and 1 s, particularly preferred between 40 ms and 0.5 s. The above-mentioned temporal upper and lower limits are advantageous for an expeditious execution of the method while simultaneously ensuring good monitoring by the operator. [0011] In a further advantageous development of the invention, an automated sequence of steps provides for an equidistant translation and/or rotation. As a result, multiple patterns can be produced which can be derived from a very simply arranged basic pattern, i.e., the sequential, one-dimensional series. Once again, it is possible to take into account the individual conditions of the retina to be treated. [0012] Thereby, the sequential, one-dimensional basic pattern can be applied at any random site and completed through translation and/or rotation in random directions. [0013] Hereby, the term “pattern” is used synonymously with the terms “sequence,” or “series.” The consecutively produced, manipulable individual spots form a first basic sequence, from which an overall pattern is produced through translation and/or rotation. [0014] A further advantageous development of the invention provides for the light source to radiate laser light, particularly in the red range. The use of laser light in the red range has the advantage of producing individual spots which are easily recognizable on the retina by the operator. [0015] A further advantageous development of the invention provides for an active influence by the operator through variation of one or several laser parameters prior to the confirmation of the next spot sequence. This results in an optimal adjustment of the required parameters in a very short period of time, wherein the operator does not have to wait for the system to display the spot sequence required at this moment. [0016] A further advantageous development of the invention provides for the confirmation by means of a joystick, voice recognition, or a foot switch, particularly a multimodal foot switch. By means of the above-mentioned device, a simple and precise input for confirming the series of individual spots suggested by the system can be made by the operator. [0017] A further advantageous development of the invention provides for the confirmation to take place only after the change of positions of the recalculated spot sequence. As a result, the individual conditions of the retina to be treated can be taken into account particularly well because individual series of individual spots suggested by the system can be rejected, and therefore coagulation takes place only at recalculated individual spots which meet the requirements for an intended coagulation but not at unintended sites. [0018] A further advantageous development of the invention provides for the distance between a next spot sequence and a previous spot sequence to be between zero and ten times that of the spot diameter, particularly preferable between 0.8 and 1.5 times the spot diameter. This allows for a variation which extends from a superimposition of the spots, i.e., an enlargement of the spot surface, to a distance with sufficient space between the individual spots. Therefore, a good individual treatment of the retina is possible. [0019] A further advantageous development of the invention provides for a change of the distance of the starting position, orientation, length, inner-sequence distance, type of spot sequence, rotation, translation and/or step length of the spot sequence with reference to the previous spot sequence to be initiated by the operator and/or based on previously determined examination data of the retina. Said very comprehensive option of changing the individual spots—their individual configuration as well as their spatial arrangement to one another—allows in turn for the best possible treatment solely on the intended sites. Since the concrete definition and determination of the above-mentioned characteristics of the spot sequence is possible due to the previously acquired examination data of the retina, a completely automated coagulation, adjusted to the retina treated moments ago, can be automatically executed exclusively on the actual intended sites. The term inner-sequence distance indicates the distance between two adjacent individual spots within the sequence. The inner-sequence distance is not kept constant but changes from one individual spot to the next. [0020] A further advantageous development of the invention provides for a temperature determination of the individual spot during the use of a therapy beam. As a result, only a brief coagulation of the retinal pigment epithelium is realized without damaging the overlying photoreceptor layer. Thereby, the therapy beam is preferably deactivated when a predetermined temperature is reached which is particularly identical for all individual spots. [0021] A further advantageous development of the invention provides for the individual spots to encircle the coagulation sites. This allows for the operator to precisely determine what the treatment area, which is to undergo coagulation through the therapy beam, looks like and whether a coagulation is indeed to be executed over the entire area. [0022] However, the herein described method for marking defined sites on a retina is not only applicable to a subsequent coagulation of the retina but, for example, also for an iridectomy or iridotomy of the iris. [0023] The problem is also solved through a system for coagulating the retina with the features as disclosed herein. [0024] In an example application, the system for coagulating the retina, having an imaging diagnostic unit, a therapy beam for coagulating coagulation sites, a pilot beam for marking the coagulation sites by means of a spot sequence, a beam deflecting unit for generating the spot sequence and for positioning the therapy beam, an electronic control unit for controlling the above devices, a software interface, and an interactive interface, is used for executing the method described above. [0025] By means of the imaging diagnostic unit, the operator can determine prior to executing the coagulation, at which concrete site of the retina said coagulation should be performed since the spot sequences marked by the pilot beam can now be observed. The therapy beam is used for coagulating the coagulation sites which were marked with the pilot beam beforehand. Therapy beam and pilot beam are controlled by a beam deflecting unit in such a way that the spot sequences of the pilot beam are projected onto the retina and that the therapy beam performs the coagulation on the marked individual spots after clearance through the confirmation by means of the confirmation signal. The entire process is controlled by the control unit which particularly controls the activation of the therapy beam as well as the beam deflection within the beam deflecting unit. The entire process is executed via a software interface. By means of the interactive interface, the confirmation by means of the confirmation signal is effected which is necessary for activating the therapy beam once the marking of the individual spots of the coagulation sites were indicated to the operator by means of the pilot beam. [0026] In an example embodiment, the imaging diagnostic unit is a laser slit lamp, a fundus camera, or a scanning laser ophthalmoscope. [0027] A number of light sources, such as LEDs, superluminescent diodes, gas discharge lamps, and particularly lasers are suited as therapy beam. Thereby, a multiwavelength laser, which can emit different colors in the visible range, is preferably used. Particularly preferable are the colors green, yellow, and red. Furthermore, it is also preferable for the multiwavelength laser to emit light in the near infrared range. The different indicated wavelengths make it possible to reach different coagulation depths. Due to the photopigment melanin, the highest absorption takes place in the green wavelength range (from 514-550 nm); the highest absorption of the blood pigment hemoglobin is achieved in the yellow spectral range (550-580 nm); however, coagulation at a high tissue penetration takes place because of the red wavelengths (630-690 nm) or by application wavelength in the near infrared range (e.g., at 810 nm). [0028] For coagulating the retina, pulse durations between 10 ms and 100 ms, particularly between 20 ms and 50 ms, have proven successful for the therapy beam. [0029] Even though pulse durations below 20 ms ensure an almost painless treatment, the effect of the treatment must be expected to be inferior. By contrast, a superior treatment effect must be expected with pulse durations above 50 ms but which can lead to scarring of the treated sites. [0030] A high coagulation effect, wherein resulting scarring diminishes over time, is achieved with pulse durations between 20 ms and 50 ms. Therefore, pulse durations between 20 ms and 50 ms are recommended for the solution for coagulating the retina as described herein. [0031] A further advantageous development of the invention provides for the pilot beam to be a laser diode which preferably radiates in the red range. The resulting markings on the retina—as already described above—are easily identifiable by the operator. [0032] A further advantageous development of the invention provides for the beam deflecting unit to coaxially project the pilot beam and the therapy beam onto the retina. This ensures that the coagulation by application of the therapy beam takes place exactly at the position indicated beforehand by the pilot beam to the operator who cleared said position by means of a confirmation signal. This ensures that the retina is not coagulated in sites which should not be coagulated, for example, because they still contain unimpaired tissue. [0033] A further advantageous development of the invention provides for the beam deflecting unit to exhibit movable lenses, mirrors, or diffractive beam splitters in the beam path. In prior art, these are well-known, reliable devices for beam deflection. Said lenses or mirrors are preferably controlled via motors; this particularly refers to galvanometrically controlled mirrors, piezo scanners, or micromirror arrays. [0034] A further advantageous development of the invention provides for the control unit to be a microcontroller which exhibits at least one input interface and one output interface and which is programmable. This allows for previously determined values about the retina to be treated as well as the present ocular media to be entered into the control unit, which therefore knows the individually required data for the pending treatment and can adjust the respective series of individual spots to the present concrete conditions. As a result, it will periodically not be necessary for the operator to refuse clearance of the displayed series of individual spots and for the system to calculate and display to the operator an alternative series. Instead, every one of the displayed series can be cleared by the operator, leading to an accelerated treatment as well as increased reliability of the treatment. [0035] A further advantageous development of the invention provides also for an interrupter which prevents at least one specific wavelength range of the therapy beam from impinging on the coagulation site. As already described above, the penetration of the radiation of the therapy beam, and therefore the coagulation, can be controlled through the use of different wavelengths. Therefore, the interrupter specifies different penetration depths of the therapy beam at a predetermined individual spot or for an entire series of individual spots. Preferably, said interrupter is a filter which can be introduced into the therapy beam. [0036] A further advantageous development of the invention provides for the interrupter to be a device which deactivates the therapy beam, particularly in the form of an aperture in the area through which the therapy beam passes. As a result, the coagulation can be altogether completed and not only selectively in one or different depths as is the case with the previously described filter. [0037] A further advantageous development of the invention additionally provides for a device for temperature determination for determining the temperature at the coagulation site while the therapy beam is directed at said site. As already described above, the photoreceptor layer above the pigment epithelium to be treated can thereby be excluded from damage. Temperature determination is preferably effected by means of a detector within the device for temperature determination, which records pressure waves from the coagulation site. Since the device for temperature determination is connected to the interrupter, the therapy beam can immediately be deactivated once the predetermined temperature is reached, resulting in the above-mentioned effect, i.e., the photoreceptor layer will not be damaged. Hereby, an indirect connection of the device for temperature determination via the control unit can be provided in addition to the direct connection to the interrupter. [0038] A further advantageous development of the invention provides for the system to be prepared for irradiating every individual spot of the serial spot sequence through the therapy beam with an individual size, form, wavelength, and duration. This also serves the individual treatment of every site of the retina. By adjustment of the parameters of size and form, the treatment area at the respective coagulation site can be precisely adjusted to desired size and form. By wavelength adjustment, a specific depth of coagulation can be achieved within the retina, as already described above. As a result, a depth-modulated laser coagulation is possible for all coagulation sites. Through adjusting the duration, the temperature of the individual coagulation sites can be varied, resulting in the degree of coagulation of the retina. Therefore, a coagulation degree-modulated laser coagulation is possible for all coagulation sites. The size of the individual spots can be varied to a large extent; preferably the diameters are in a range between 50 - 1000 p.m. Thereby, the size of the individual spots can be modulated within a series of individual spots (which can be designed particularly as a straight line) or through a change of the sizes of the individual spots from line to line. [0039] In addition to a preferably homogenous laser therapy of the retina with a predetermined equidistant grid, a predetermined equal temperature, and a predetermined equal treatment depth due to the applied wavelength, a multidimensional modulation of the degree of treatment of the retina is also possible with a system, according to the invention, which exhibits a monochromatic laser or a polychromatic laser system, an ophthalmic scan system, and a temperature measuring system. For example, this can result in the same therapeutic benefit for the patient without having to completely coagulate excessively large areas of the retina and to lose said areas for the ability to see. Simultaneously, however, a retinal detachment and therefore aggravated progress of the disease is avoided. [0040] For example, this is possible because classic coagulation spots are set in a rough grid and sub-coagulative treatment occurs in the intermediate spaces without damage to the photoreceptors. Thereby, this method is possible line by line or within a pattern. [0041] A selective retina therapy can also be performed on the basis of a μ-second laser pulses. Thereby, the selective absorption of the particularly green laser light is utilized within the retinal pigment epithelium and ensures by means of the temporally limited exposure in the μ-second range that, within the thermal relaxation time, almost the entire heat remains in the selectively absorbing pigment epithelium and does not reach the photoreceptor layer. This induces the damaged pigment epithelium to regenerate without showing any visible damage in the fundus image. [0042] A different selective retinal therapy is executed in planar fashion by application of a scanned CW laser beam. Thereby, the exposure time is appropriately limited through the scanning speed within the thermal relaxation time. [0043] With a controlled, selective retina coagulation, different absorption properties in the retinal pigment epithelium and different local transmissions of the ocular media are taken into account. As a result, locally different zones of damage of the retinal pigment epithelium can be treated. [0044] An optoacoustic measuring system or an optical measuring system, for example, are used as temperature measuring system. By choosing a wavelength in the yellow, green, red, or infrared spectral range, a homogenous coagulation depth or hyperthermia depth can be set. Choosing equidistant individual spot distances and their diameters allows for a structuring of the homogeneity within the surface. [0045] A targeted planning of the treatment for the best possible individual therapy is possible due to diagnostic data ascertained beforehand. Such data were ascertained particularly on the basis of fundus images (color images, angiography images, autofluorescence images, etc.), OCT images (optical coherence tomography), or confocally scanned images. Subsequently, the treatment is performed by a partly or fully automated generation of treatment parameters and a partly or fully automated execution of the treatment. [0046] The following lasers are used: E.g., argon lasers, diode lasers, diode-pumped solid-state lasers, diode-pumped semiconductor lasers, fiber lasers, and frequency-doubled Nd:YAG lasers. The lasers can be applied as pulsed laser or CW laser. [0047] The programmed control unit is preferably designed as hard-wired programmed or stored-program controller. Preferably, the controller exhibits a processor architecture. [0048] The positioning of the focused laser beam is effected automatically or semiautomatically by use of deflection elements which can deflect the beam two-dimensionally. For example, this can be effected through galvanometric mirror scanners, piezo-driven optical elements, acousto-optical elements, electro-optical elements, or laterally moving lenses. Thereby, the beam positioning elements can move the beam in a translative, torsional, tilted, or rotating fashion. Said elements can be reflecting as well as refractive in transmission. [0049] The therapy beam is either parallel or bundled. For example, it exhibits an elliptic, preferably circular polarization. However, it is also possible to use linearly polarized or unpolarized therapy beams. BRIEF DESCRIPTION OF THE DRAWINGS [0050] Further details of the invention are described as follows by means of the attached figures: [0051] FIG. 1 shows a series of patterns of individual spots originating from one another through translation; [0052] FIG. 2 shows a series of patterns of individual spots originating from one another through rotation; [0053] FIG. 3 shows a series of patterns of individual spots originating through translation and change of the initial position as well as omission of a spot sequence; [0054] FIG. 4 shows two patterns of individual spots originating through translation and change of the length of the sequence; [0055] FIG. 5 shows a pattern of individual spots originating through translation, change of the starting point and length of the sequence; [0056] FIG. 6 shows a pattern of individual spots originating through translation and change of the distances between the individual spots; [0057] FIG. 7 shows patterns of individual spots originating through rotation of individual spots arranged on a circular arc; [0058] FIG. 8 shows patterns of individual spots originating through rotation of individual spots arranged as circle segment; [0059] FIG. 9 shows a pattern of coagulation sites originating through lateral change, change of size, change of the length of the sequence and the inner sequence distance; [0060] FIG. 10 shows a series of coagulation sites which are coagulated with different wavelengths; [0061] FIG. 11 shows a series of coagulation sites which are coagulated through different temperatures; and [0062] FIG. 12 depicts a system for coagulating the retina according to an example embodiment of the invention. DETAILED DESCRIPTION [0063] FIG. 1 shows in the first depiction from the left the basic form of a sequential, one-dimensional series of individual spots, which serves as starting point for the additional depictions of FIG. 1 and their multiple applications, as described in the following. [0064] The series consists of eight individual spots which are arranged equidistantly to one another and run in vertical direction. The first individual spot is the depicted individual spot in the top position. Starting with said spot, the sequence is generated continuously from top to bottom in the depicted order. [0065] Starting from said basic form, a pattern of individual spots—depicted in the second drawing from the left—arranged equidistantly to one another in a 7×16 matrix is obtained through a translation of the basic vertical series in the left drawing. [0066] Deviating from the basic form depicted in the first drawing from the left, the sequential, one-dimensional series can also exhibit a horizontal or other direction. Starting with the respective basic form, the patterns depicted in the additional drawings in FIG. 1 can be obtained. Thereby, the size of the matrix of individual spots arranged equidistantly to one another depends on the number of translations. [0067] The left drawing of FIG. 2 shows a shortened initial sequence with four individual spots when compared to the basic sequence in FIG. 1 with eight individual spots. The pattern in the second depiction from the left is obtained from the basic sequence in the left depiction in such a way that advancing from left to right one rotation each is achieved around a rotation center (not depicted) with an alternating sequence length between three and four individual spots, wherein the sequences with three individual spots are set in the gaps of the sequences with four individual spots. This is achieved in such a way that, in addition to the rotation, a translation of the initial individual spots is additionally executed in transverse direction. [0068] By contrast, the second drawing from the right in FIG. 2 shows a plain rotation between the first series of individual spots running in vertical direction and the second series slightly rotated counterclockwise as a result. The initial series—as in FIG. 1 —also exhibits eight individual spots, but the distance between the fourth and fifth individual spot is significantly greater. Said distance is chosen in such a way that no individual spots are present in a depicted circle. The rotation center is also the center of the depicted circle. A continuous and repeated rotation around the same angle of rotation indicated in the second drawing from the right in FIG. 2 results in the radial drawing on the right in FIG. 2 . [0069] An irregular translation (which can also be called a modification of the initial position) is executed in the two left drawings in FIG. 3 . Thereby, a vertical initial series of five individual spots is shown in the left drawing. [0070] The second drawing from the left shows a vertical initial series of six individual spots which—similar to the two drawings on the right of FIG. 2 —exhibits an increased distance between the upper half and the lower half (inner sequence distance) of the respective three individual spots. [0071] However, in the third drawing from the left in FIG. 3 , a vertical series of seven individual spots is completed to a pattern through a consistent translation; however, said pattern is altered in respect of the form of the individual spots between the first and second (as well as the fifth and sixth) series relative to the third and fourth (as well as the seventh) series in such a way that the latter spot positions can be omitted by the operator, i.e., they do not constitute coagulation sites. [0072] The right drawing in FIG. 3 shows a special application, wherein the grey line represents a blood vessel. The operator omits those spot positions which would impinge on the blood vessel. [0073] In the two drawings on the left in FIG. 4 , translations and changes in the sequence length with vertical symmetry of the spot sequence are superimposed. In the right drawing this leads to a pattern which represents a triangle with decreasing sequence length from left to right. [0074] In the drawing on the right in FIG. 4 , a translation is also superimposed with a change of the sequence length of the spot sequence but the sequence length varies due to the absence of symmetry. [0075] FIG. 5 shows an irregular pattern which is obtained through the initial series of four vertical individual spots, as depicted on the very left, through varying the sequence length, translation, and change of the initial positions. [0076] FIG. 6 shows a pattern which is formed through translation of a basic form in vertical direction. Contrary to the previous patterns, the distances of the individual spots of the basic form are changed with every translation, resulting in a pattern in the form of a “fanned out” 6×6 matrix. [0077] The patterns in FIG. 7 and FIG. 8 are, in contrast to the previously described patterns, not based on the basic form of a sequential, one-dimensional series of individual spots in accordance with the drawing on the left in FIG. 1 . Similar to the two drawings on the right in FIG. 2 , no individual spots are present within the depicted circle. [0078] The drawing on the left in FIG. 7 shows the applied basic form as a circular arc of individual spots. Through a slight rotation, this basic form in the form of a circular arc results in the pattern depicted in the second drawing from the left, and a 180° rotation results in the pattern depicted in the third drawing from the left. Through multiple rotations in conjunction with the omission of spot positions by the operator, said basic form can be completed to a pattern in the form of a full circle. [0079] According to the drawing on the left in FIG. 8 , a circular segment, wherein individual spots are arranged, is used as basic form in this embodiment. Starting with said basic form in the form of a circular segment, the pattern depicted in the second drawing from the left can be produced with a single rotation, and the third drawing from the left can be produced through multiple rotations. As can be seen in the drawing on the right in FIG. 8 , the patterns can be reduced once again by the operator through omission of spot positions. Preferably, the inner arc forms the basic sequence in the circular segment. In order to “fill” the circular segment, the following sequence is produced on a greater radius, wherein, as a rule, the distance and the number of individual spots in the basic sequence are enlarged. This approach is advantageous because the innermost arc, i.e., the basic sequence, is placed near the macula where the demands are highest. Said demands decrease accordingly in the outward direction. [0080] The patterns shown in FIGS. 1 to 8 are only exemplary and can be modified arbitrarily for producing any desired pattern. This allows for a precise response to the individual case to be treated and for setting the patterns in such a way that coagulation occurs solely at the required coagulation points. The individual spots shown in FIGS. 1 to 8 are produced by the pilot beam, and the therapy beam will subsequently coagulate said sites. [0081] Based on a series of individual spots in horizontal direction, FIG. 9 shows a pattern, wherein the uppermost row was altered through modification of the sequence length as wells as the inner sequence distances. However, these are not the points marked by the pilot beam but the coagulation sites subsequently caused by the therapy beam. Hereby, the coagulation sites are varied according to the respective size of the coagulation site required for the individual case. Preferably, the diameters of such coagulation sites range from 50 to 500 μm. [0082] In addition to a translation in vertical direction, a change of the diameter of the individual spots was also made between the lowest and second to lowest (and also between the second to lowest and second to highest) series of individual spots. However, between the second series from the top and the uppermost series, not only a partial change of the diameter of the individual spots was made (i.e., every other individual spot was reduced from the size in the second series from the top to a size according to the second series from the bottom) but also a sequence extension from four to seven individual spots as well as a change in the inner sequence distances was executed. [0083] FIG. 10 shows a grid of coagulation points with equal diameters which were irradiated with different wavelengths. Hereby, a wavelength of 577 nm was used for yellow light (550-580 nm), a wavelength of 532 nm for green light (514-550 nm), and a wavelength of 659 nm for red light (630-680 nm). The series from left to right is as follows: Yellow, green, red, green, yellow, green, red. Due to the different applied wavelengths, the primary absorption of energy in the retina takes place in different depths. As a result, coagulation occurs in the upper area of the retina due to the highest absorption of the blood pigment hemoglobin in the yellow spectral range. The highest absorption in the green wavelength range is caused by the photopigment melanin, resulting in coagulation in the medium depth of the retina. Red wavelengths cause the deepest penetration in the retina, resulting in the highest degree of coagulation. [0084] Due to the targeted irradiation of different coagulation sites with different wavelengths (colors), a depth modulation can be achieved. As a result, the individually required treatment can be taken into account. [0085] FIG. 11 shows the same row of coagulation sites as FIG. 10 . However, in FIG. 11 , a modulation with different coagulation temperatures instead of different light wavelengths is executed. Hereby, coagulation occurs monochromatic at a wavelength of, e.g., 532 nm (i.e., in the green wavelength range). Due to the different coagulation temperatures of, e.g., 45°, 50°, 60°, different degrees of coagulation are achieved within the depicted coagulation sites. Thereby, the length of the arrows indicates the degree of coagulation in the retina, wherein long arrows represent a higher degree of coagulation than shorter arrows. This results in an equidistant, monochromatic coagulation degree-modulated laser coagulation or hyperthermia. [0086] Referring to FIG. 12 , in an example embodiment, the system for coagulating the retina, having an imaging diagnostic unit 1 , a therapy beam source 4 emitting a pilot beam for coagulating coagulation sites, a pilot beam source 5 emitting a pilot beam for marking the coagulation sites by means of a spot sequence, a beam deflecting unit 2 for generating the spot sequence and for positioning the therapy beam, an electronic control unit 8 for controlling the above devices, a software interface 9 , and an interactive interface 10 , is used for executing the method described above. [0087] By application of the imaging diagnostic unit, the operator can determine prior to executing the coagulation, at which concrete site of the retina said coagulation should be performed since the spot sequences marked by the pilot beam can now be observed. The therapy beam is used for coagulating the coagulation sites which were marked with the pilot beam beforehand. Therapy beam and pilot beam are controlled by beam deflecting unit 2 in such a way that the spot sequences of the pilot beam are projected onto the retina and that the therapy beam performs the coagulation on the marked individual spots after clearance through the confirmation by reception of the confirmation signal. The entire process is controlled by the control unit 8 which particularly controls the activation of the therapy beam source 4 as well as the beam deflection within the beam deflecting unit 2 . The entire process is executed via a software interface 9 . By use of the interactive interface 10 , the confirmation by means of the confirmation signal is effected which is necessary for activating the therapy beam source 4 once the marking of the individual spots of the coagulation sites were indicated to the operator by use of the pilot beam. [0088] For example, the imaging diagnostic unit 1 is a laser slit lamp, a fundus camera, or a scanning laser ophthalmoscope. [0089] A number of therapy beam sources 4 light sources, such as LEDs, superluminescent diodes, gas discharge lamps, and particularly lasers are suited to emit the therapy beam. Thereby, a multiwavelength laser, which can emit different colors in the visible range, is used, for example. Particularly examples are the colors green, yellow, and red. Furthermore, it is also possible for the multiwavelength laser to emit light in the near infrared range. The different indicated wavelengths make it possible to reach different coagulation depths. Due to the photopigment melanin, the highest absorption takes place in the green wavelength range (from 514-550 nm); the highest absorption of the blood pigment hemoglobin is achieved in the yellow spectral range (550-580 nm); however, coagulation at a high tissue penetration takes place because of the red wavelengths (630-690 nm) or by means of a wavelength in the near infrared range (e.g., at 810 nm). [0090] For coagulating the retina, pulse durations between 10 ms and 100 ms, particularly between 20 ms and 50 ms, have proven successful for the therapy beam. [0091] Even though pulse durations below 20 ms ensure an almost painless treatment, the effect of the treatment must be expected to be inferior. By contrast, a superior treatment effect must be expected with pulse durations above 50 ms but which can lead to scarring of the treated sites. [0092] A high coagulation effect, wherein resulting scarring diminishes over time, is achieved with pulse durations between 20 ms and 50 ms. Therefore, pulse durations between 20 ms and 50 ms are recommended for the solution of coagulating the retina as described herein. [0093] A further embodiment of the invention provides for the pilot beam to be a laser diode which for example radiates in the red range. The resulting markings on the retina—as already described above—are easily identifiable by the operator. [0094] A further embodiment of the invention provides for the beam deflecting unit 2 to coaxially project the pilot beam and the therapy beam onto the retina. This ensures that the coagulation by means of the therapy beam takes place exactly at the position indicated beforehand by the pilot beam to the operator who cleared said position by entering of a confirmation signal. This ensures that the retina is not coagulated in sites which should not be coagulated, for example, because they still contain unimpaired tissue. [0095] A further embodiment of the invention provides for the beam deflecting unit 2 to exhibit movable lenses, mirrors, or diffractive beam splitters in the beam path. In prior art, these are well-known, reliable devices for beam deflection. Said lenses or mirrors are preferably controlled via motors; this particularly refers to galvanometrically controlled mirrors, piezo scanners, or micromirror arrays. [0096] A further advantageous development of the invention provides for the control unit 8 to be a microcontroller which exhibits at least one input interface and one output interface and which is programmable. This allows for previously determined values about the retina to be treated as well as the present ocular media to be entered into the control unit, which therefore knows the individually required data for the pending treatment and can adjust the respective series of individual spots to the present concrete conditions. As a result, it will not be necessary for the operator to periodically refuse clearance of the displayed series of individual spots and for the system to calculate and display to the operator an alternative series. Instead, every one of the displayed series can be cleared by the operator, leading to an accelerated treatment as well as increased reliability of the treatment. [0097] A further advantageous development of the invention provides also for an interrupter 3 which prevents at least one specific wavelength range of the therapy beam from impinging on the coagulation site. As already described above, the penetration of the radiation of the therapy beam, and therefore the coagulation, can be controlled through the use of different wavelengths. Therefore, the interrupter 3 specifies different penetration depths of the therapy beam at a predetermined individual spot or for an entire series of individual spots. In one example, said interrupter 3 is a filter which can be introduced into the therapy beam. [0098] A further advantageous development of the invention provides for the interrupter 3 to be a device which deactivates the therapy beam, particularly in the form of an aperture in the area through which the therapy beam passes. As a result, the coagulation can be altogether completed and not only selectively in one or different depths as is the case with the previously described filter. [0099] A further advantageous development of the invention additionally provides for a device for temperature determination 6 for determining the temperature at the coagulation site while the therapy beam is directed at said site. As already described above, the photoreceptor layer above the pigment epithelium to be treated can thereby be excluded from damage. Temperature determination is preferably effected by means of a detector 6 within the device for temperature determination, which records pressure waves from the coagulation site. Since the device for temperature determination is connected to the interrupter 3 , the therapy beam can immediately be deactivated once the predetermined temperature is reached, resulting in the above-mentioned effect, i.e., the photoreceptor layer will not be damaged. Hereby, an indirect connection of the device for temperature determination 6 via the control unit can be provided in addition to the direct connection to the interrupter 3 . [0100] A further advantageous development of the invention provides for the system to be prepared for irradiating every individual spot of the serial spot sequence through the therapy beam with an individual size, form, wavelength, and duration. This also serves the individual treatment of every site of the retina. By means of size and form, the treatment area at the respective site can be precisely adjusted to the desired size and form. By the wavelength adjustment, a specific depth of coagulation can be achieved within the retina, as already described above. As a result, a depth-modulated laser coagulation is possible for all coagulation sites. Through adjusting the duration, the temperature of the individual coagulation sites can be varied, resulting in the degree of coagulation of the retina. Therefore, a coagulation degree-modulated laser coagulation is possible for all coagulation sites. The size of the individual spots can be varied to a large extent; preferably the diameters are in a range between 50-1000 μm. Thereby, the size of the individual spots can be modulated within a series of individual spots (which can be designed particularly as a straight line) or through a change of the sizes of the individual spots from line to line.

1a

FIELD OF THE INVENTION [0001] The present invention relates to synthetic peptides and to pharmaceutical compositions comprising them useful for the treatment of systemic lupus erythematosus (SLE) in humans. BACKGROUND OF THE INVENTION [0002] Autoimmune diseases are characterized by immune responses that are directed against self antigens. These responses are maintained by the persistent activation of self-reactive T lymphocytes. T lymphocytes are specifically activated upon recognition of foreign and/or self antigens as a complex with self major histocompatibility complex (MHC) gene products on the surface of antigen-presenting cells (APC). [0003] Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown origin and cure. Despite the extensive research on the mechanisms underlying the induction and development of SLE, the information available on the etiology of the disease is very limited due to the heterogeneity of SLE patients on one hand, and the lack of an experimental model in which the induction of the disease could be controlled, on the other hand. [0004] The cause of SLE is unknown and it has heterogeneous clinical manifestations. Furthermore, no specific treatment aimed towards the prevention or cure of SLE is available. Despite the extensive research on the mechanisms underlying the induction of SLE, the information on the etiology of the disease is very limited. Studies on SLE have been performed until recently using peripheral blood lymphocytes (PBL) of patients at different clinical stages and under various treatment protocols. Alternatively, murine strains that develop spontaneous SLE-like disease were investigated as a model for SLE. This kind of analysis led to incomplete and confusing interpretations of the role of various immunological and non-immunological factors in either inducing or sustaining the disease, mainly due to the heterogeneity of patients on one hand and the inability to control the induction phase of the disease in murine SLE strains on the other hand. [0005] Several years ago, an animal model of SLE has been established in the laboratory of one of the present inventors. This model, based on the concept of the idiotypic network, developed a wide spectrum of lupus-related autoantibodies and clinical manifestations (Mendlovic et al., 1988). The induction was carried out by the immunization of mouse strains that do not develop any spontaneous autoimmune disorders, with a human anti-DNA monoclonal antibody (mAb) which bears a common idiotype termed 16/6 Id (Shoenfeld et al., 1983). Following immunization, the mice produced antibodies specific to the 16/6 Id, antibodies that bear the 16/6 Id and antibodies directed against different nuclear antigens (dsDNA, ssDNA, Sm, ribonucleoprotein (RNP), Ro, La and others). The serological findings were associated with leukopenia, elevated erythrocyte sedimentation rate, proteinuria, abundance of immune complexes in the kidneys and sclerosis of the glomeruli (Mendlovic et al., 1988), which are typical manifestations of SLE. The present inventors have further shown that the experimental disease could be induced by a murine anti-16/6 Id mAb (Mendlovic et al., 1989) and by the mouse anti-anti 16/6 Id (16/6Id+) mAb (Waisman et al., 1993). The induction of the disease is genetically controlled, and thus is strain dependent (Mendlovic et al., 1990). This unique model for the induction of experimental SLE provides the appropriate tools to clearly dissect the different steps and the linked immune parameters involved in the induction and development of SLE. [0006] SLE is a systemic autoimmune disease characterized by the formation of autoantibodies against self-antigens, such as DNA, Sm, Ro, La, RNP, cardiolipin and histones. The etiology of SLE is unknown, and understanding the mechanism by which these self-antibodies arise might provide insight to this problem. For this purpose, the present inventors have produced a variety of monoclonal autoantibodies derived from C3H.SW mice in which experimental SLE was induced. As a rule, the monoclonal autoantibodies that were capable of eliciting antibodies that bear the 16/6 Id or react with it were found to be pathogenic and thus capable of inducing experimental SLE (Fricke et al., 1990; Sthoeger et al., 1993). Later on, the variable (V) regions of nine autoantibodies that bind either DNA or HeLa nuclear extract (NE), isolated from the C3H.SW mice with experimental SLE, were sequenced (Waisman and Mozes, 1993). Monoclonal antibodies with different specificity were analyzed in an attempt to determine the connections between the different autoantibodies. Three mAb were found to bind DNA, and were shown to exhibit sequence characteristics of pathogenic anti-DNA antibodies. One of these mAb, designated 2C4C2, was shown to use a heavy (H) chain V region gene (V H ) identical to the V H of anti-DNA mAb isolated from other lupus-prone mice, namely (NZB x NZW)F 1 . The light (L) chain V region gene (V L ) of mAb 2C4C2 is 98% homologous to the V L of another anti-DNA mAb, also isolated from (NZB x NZW)F 1 mice. The other two anti-DNA mAb, designated 5G12-4 and 5G12-6, share 93% of their V H sequences with that of mAb 2C4C2. Six mAb bound proteins of HeLa NE. The nine mAb use a total of five V H and four V L germ-line genes, demonstrating that the autoantibodies induced in mice with experimental SLE do not originate from one B cell clone. Three of the nine V H and V L were identical in sequence to germ-line genes, while at least three others had somatic mutations. The latter suggests that these autoantibodies arise in mice by both usage of existing (pre-immune) B cells, and through an antigen-driven process. Furthermore, it appears that autoantibodies found in mice with experimental SLE use genetic elements similar to those used by mAb that were isolated from mouse strains which develop lupus spontaneously. [0007] T cells play an important role in the induction and development of experimental SLE. Thus, T cell lines and clones specific to the 16/6 Id were shown to induce experimental SLE in syngeneic recipients similarly to the 16/6 antibody. Therefore, following the inoculation of the activated cells of the lines, the mice developed both the serology and the renal damage which is typical to SLE (Fricke et al., 1991). Furthermore, a 16/6 Id specific T cell line of C3H.SW origin induced SLE in C57BL/6 mice that were shown to be resistant to the induction of the disease following injections with either the 16/6 Id or the anti-16/6 Id mAb (Mendlovic et al., 1990). [0008] In an attempt to identify the pathogenic region of the 16/6 Id, (Fab′) 2 fragments were prepared of the 16/6 Id mAb and were found to retain the specificity and pathogenic capacity of the whole 16/6 Id molecule (Ruiz et al., 1994). [0009] The mAb 5G12 that was isolated from mice with experimental SLE and was shown to bind DNA and bear the 16/6 Id, is capable of inducing experimental SLE in mice (Waisman et al., 1993). T cells that react specifically to mAb by proliferation, are probably reacting to peptides representing sequences from their complementarity-determining regions (CDR). It is very likely that the T cells recognize the V regions of the above antibodies since they do not react with other antibodies that carry the same constant region but have different specificities. Within the variable region, the regions with the highest probability to be recognized are the CDR, since those are the regions that differ the most between the various antibodies. The CDR regions of the V H sequences of the nine pathogenic murine mAb mentioned above that induce SLE in mice, are boxed in FIG. 1 of Waisman and Mozes, 1993, in which the complete nucleotide and deduced amino acid sequences for the V H of the nine mAb are presented. SUMMARY OF THE INVENTION [0010] It is an object of the present invention to provide means for specific treatment of patients with SLE. [0011] For this purpose, the invention provides peptides and analogs thereof based on the CDR regions of pathogenic monoclonal autoantibodies isolated from mice with experimental SLE. [0012] Thus, in one aspect, the invention relates to a synthetic peptide selected from the group consisting of: [0013] (i) a peptide of at least 12 and at most 30 amino acid residues based on a complementarity-determining region (CDR) of the heavy or light chain of a pathogenic anti-DNA monoclonal antibody that induces a systemic lupus erythematosus (SLE)-like disease in mice (hereinafter CDR-based peptide), a salt or a chemical derivative thereof; [0014] (ii) an analog of a CDR-based peptide defined in (i), a salt or a chemical derivative thereof; [0015] (iii) a dual synthetic peptide comprising two such peptides of (i) or analogs of (ii) covalently linked to one another either directly or through a short linking chain; [0016] (iv) a peptide polymer comprising a plurality of sequences of said peptide (i) or analog thereof (ii); and [0017] (v) a peptide polymer (iv) attached to a macromolecular carrier. [0018] In one embodiment of this aspect, the synthetic peptide is capable of: [0019] (i) inhibiting specifically the proliferative response and cytokine secretion of T lymphocytes of mice that are high responders to SLE-inducing autoantibodies; or [0020] (ii) inhibiting development of SLE in mice that are susceptible to SLE-induction by pathogenic autoantibodies. [0021] The synthetic peptides and analogs thereof according to the invention may be selected from the group consisting of peptides having the sequences I to V herein, wherein: [0022] (i) the peptide of sequence I has the formula: TGYYX 1 X 2 X 3 X 4 X 5 QSPEKSLEWIG [I] [0023] wherein X 1 is Met, Ala or Val; X 2 is Gin, Asp, Glu or Arg; X 3 is Trp or Ala; X 4 is Val or Ser; and X 5 is Lys, Glu or Ala; [0024] (ii) the peptide of sequence II has the formula: EINPSTGGX 6 X 7 X 8 X 9 X 10 X 11 X 12 KAKAT [II] [0025] wherein X 6 and X 7 are each Thr, Val or Ala; X 8 is Tyr or Phe; X 9 is Asn or Asp; X 10 is Gin or Glu; X 11 is Lys or Glu, and X 12 is Phe or Tyr; [0026] (iii) the peptide of sequence III has the formula: YYCARX 13 X 14 X 15 X 16 PYAX 17 X 18 YWGQGS [III] [0027] wherein X 13 is Phe, Thr or Gly; X 14 is Leu, Ala or Ser; X 15 is Trp or Ala; X 16 is Glu or Lys; X 17 is Met or Ala, and X 18 is Asp, Lys or Ser; [0028] (iv) the peptide of sequence IV has the formula: GYNX 19 X 20 X 21 X 22 X 23 X 24 SHGX 25 X 26 LEWIG [IV] [0029] wherein X 19 is Met or Ala; X 20 is Asn, Asp or Arg; X 21 is Trp or Ala; X 22 is Val or Ser; X 23 is Lys or Glu; X 24 is Gln or Ala; X 25 is Lys or Glu, and X 26 is Ser or Ala; and [0030] (v) the peptide of sequence V has the formula: YYCARX 27 X 28 X 29 YGX 30 X 31 X 32 GQGTL [V] [0031] wherein X 27 is Ser or Phe; X 28 is Gly or Ala; X 29 is Arg, Ala or Glu; X 30 is Asn or Asp; X 31 is Tyr or Phe, and X 32 is Trp, His or Ala. [0032] In preferred embodiments, peptides I to V have the sequences Ia-Va herein: TGYYMQWVKQSPEKSLEWIG (Ia) EINPSTGGTTYNQKFKAKAT (IIa) YYCARFLWEPYAMDYWGQGS (IIIa) GYNMNWVKQSHGKSLEWIG (IVa) YYCARSGRYGNYWGQTL (Va) [0033] Peptides Ia to IIIa are based on the CDR1, CDR2 and CDR3 regions, respectively, of the V H chain of mAb 5G12, and peptides IVa and Va are based on the CDR1 and CDR3 regions, respectively, of the V H chain of mAb 2C4C2 (Waisman and Mozes, 1993). [0034] In another aspect, the invention relates to pharmaceutical compositions for the treatment of SLE comprising a synthetic peptide or peptide polymer of the invention and a pharmaceutically acceptable carrier. [0035] In still another aspect, the invention relates to a method of treatment of a SLE patient comprising administering to a SLE patient an effective amount of a synthetic peptide or peptide polymer of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0036] FIGS. 1 A-B show the presence of anti-DNA antibodies in sera of SJL ( 1 A) and BALB/c ( 1 B) mice immunized with mAb 5G12, peptides Ia and IIIa and a control peptide 278, or non-immunized. Sera of individual SJL or BALB/c mice immunized with either one of the indicated antigens, taken three months after the booster injection, and sera of age-matched naive mice, were tested for anti-ssDNA antibody titers. Following incubation with the diluted sera, goat anti-mouse IgG (γ-chain specific) conjugated to peroxidase was added. Results were expressed as mean OD of each mouse group. [0037] FIGS. 2 A-B show the presence of HeLa anti-nuclear extract (NE) antibodies in the sera of SJL ( 2 A) and BALB/c ( 2 B) mice immunized with same antigens as in FIG. 1. [0038] FIGS. 3 A-B show the presence of anti-RNP, Sm, Ro and La antibodies in the sera of SJL ( 3 A) and BALB/c ( 3 B) mice immunized with peptides Ia and IIIa or with control peptide 278, and normal mice. [0039] FIGS. 4 A-B show the presence of anti-DNA ( 4 A) and anti-HeLa NE ( 4 B) antibodies in the sera of BALB/c mice tolerized with peptide Ia or with control peptide p307, and immunized with either peptide Ia or mAb 5G12. [0040] [0040]FIGS. 5 a - b show in vivo inhibition of lymph node cell (LNC) proliferation responses in BALB/c ( 5 a ) and SJL ( 5 b ) mice to the CDR-based peptides Ia and IIIa, respectively, following treatment with the latter. [0041] [0041]FIGS. 6 a - b show in vivo inhibition of LNC to mAb 5G12 in BALB/c ( 6 a ) or SJL ( 6 b ) mice treated with peptide Ia and IIIa, respectively. [0042] [0042]FIGS. 7 a - b show in vivo inhibition of LNC proliferation to the human monoclonal anti-DNA 16/6 Id antibody in BALB/c ( 7 a ) and SJL ( 7 b ) mice treated with peptide Ia and IIIa, respectively. [0043] [0043]FIG. 8 shows binding of peptides Ia and IIIa to the surface of splenic antigen-presenting cells of different mouse strains. [0044] [0044]FIG. 9 shows antibody titers in sera of SLE patients and healthy human controls by testing their sera for the ability to bind the peptides Ia, IIa and IIIa, or mAb 5G12 or a control peptide. DETAILED DESCRIPTION OF THE INVENTION [0045] The present invention relates to synthetic peptides that are based on the CDR of monoclonal pathogenic autoantibodies isolated from mice with experimental SLE. Such monoclonal antibodies are obtained from supernatants of hybridomas produced by fusion, for example, of spleen cells of C3H.SW mice immunized with an anti-16/6 Id mAb, with X63.653 plasmacytoma cells (Waisman and Mozes, 1993). [0046] Examples of such peptides are those of formulas Ia to Va herein, based on, respectively, the CDR1, CDR2 and CDR3 regions of the heavy chain of mAb 5G12 and the CDR1 and CDR3 regions of the heavy chain of mAb 2C4C2 (Waisman and Mozes, 1993), and analogs thereof. [0047] Analogs of parent peptides Ia-Va contemplated by the invention include substitution, deletion and addition analogs as described herein. Substitution analogs have amino acid substitutions at different positions, these substitutions being made based on the volume, hydrophobic-hydrophilic pattern and charge of the amino acids. [0048] Amino acids may be divided along the lines of volume, hydrophobic-hydrophilic pattern and charge. With respect to volume, those of ordinary skill in the art understand that the amino acids with the largest volume are Trp, Tyr, Phe, Arg, Lys, Ile, Leu , Met and His, while those with the smallest volumes are Gly, Ala, Ser, Asp, Thr and Pro, with others being in between. [0049] With respect to hydrophobic-hydrophilic pattern, it is well known that the amino acids Gly, Ala, Phe, Val, Leu, Ile, Pro, Met and Trp are hydrophobic, whereas all of the remaining amino acids are hydrophilic. Among the hydrophilic amino acids, Ser, Thr, Gln, and Tyr have no charge, while Arg, Lys, His and Asn have a positive charge and Asp and Glu have negative charges. [0050] In selecting peptides to be tested for their potential in inhibiting the proliferative response of T lymphocytes of mice that are high responders to SLE-inducing autoantibodies, it is important that the substitutions be selected from those which cumulatively do not substantially change the volume, hydrophobic-hydrophilic pattern and charge of the corresponding portion of the unsubstituted parent peptide. Thus, a hydrophobic residue may be substituted with a hydrophilic residue, or vice-versa, as long as the total effect does not substantially change the volume, hydrophobic-hydrophilic pattern and charge of the corresponding unsubstituted parent peptide. [0051] It should be understood that other modifications of the peptides and analogs thereof are also contemplated by the present invention. Thus, the peptide or analog of the present invention is intended to include a “chemical derivative” thereof which retains at least a portion of the function of the peptide which permits its utility in preventing or inhibiting T cell proliferative responses and autoimmune disease. [0052] A “chemical derivative” of a peptide or analog of the present invention contains additional chemical moieties not normally a part of the peptide. Covalent modifications of the peptide are included within the scope of this invention. Such modifications may be introduced into the molecule by reacting targeted amino acid residues of the peptide with an organic derivatizing agent that is capable of reacting with selected side chains or terminal residues. Many such chemical derivatives and methods for making them are well known in the art. [0053] Also included in the scope of the invention are salts of the peptides and analogs of the invention. As used herein, the term “salts” refers to both salts of carboxyl groups and to acid addition salts of amino groups of the peptide molecule. Salts of a carboxyl group may be formed by means known in the art and include inorganic salts, for example, sodium, calcium, ammonium, ferric or zinc salts, and the like, and salts with organic bases such as those formed for example, with amines, such as triethanolamine, arginine, or lysine, piperidine, procaine, and the like. Acid addition salts include, for example, salts with mineral acids such as, for example, hydrochloric acid or sulfuric acid, and salts with organic acids, such as, for example, acetic acid or oxalic acid. Such chemical derivatives and salts are preferably used to modify the pharmaceutical properties of the peptide insofar as stability, solubility, etc., are concerned. [0054] Examples of peptides and analogs thereof are as follows: [0055] (i) Peptide Ia of the formula: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 T G Y Y M Q W V K Q  S  P  E  K  S  L  E  W  I  G (Ia) [0056] and substitution analogs thereof in which Met at position 5 is substituted by either Ala or Val; Gln at position 6 is substituted by either Asp, Glu or Arg; Trp at position 7 is substituted by Ala; Val at position 8 by Ser; and Lys at position 9 is substituted by either Glu or Ala; and deletion analogs thereof in which up to 5 amino acid residues are deleted from the C-terminal of peptide Ia. [0057] (ii) Peptide IIa of the formula: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 E I N P S T G G T T  Y  N  Q  K  F  K  A  K  A  T (IIa) [0058] and substitution analogs thereof in which Thr in positions 9 and 10 are each substituted by either Val or Ala; Tyr at position 11 is substituted by Phe; Asn at position 12 is substituted by Asp; Gln at position 13 by Glu; Lys at position 14 by Glu; and Phe at position 15 by Tyr, and deletion analogs thereof in which up to 5 amino acid residues are deleted from the C-terminal of peptide IIa [0059] (iii) Peptide IIIa of the formula: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Y Y C A R F L W E P  Y  A  M  D  Y  W  G  Q  G  S (IIIa) [0060] and substitution analogs thereof in which Phe at position 6 is substituted by either Thr or Gly; Leu at position 7 is substituted by either Ala or Ser; Trp at position 8 is substituted by Ala; Glu at position 9 is substituted by Lys; Met at position 13 by Ala; and Asp at position 14 by either Lys or Ser; and deletion analogs thereof in which up to 5 amino acid residues are deleted from the C-terminal of peptide IIIa. [0061] (iv) Peptide IVa of the formula: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 G Y N M N W V K Q S  H  G  K  S  L  E  W  I  C (IVa) [0062] and substitution analogs thereof in which Met at position 4 is substituted by Ala; Asn at position 5 is substituted by either Asp or Arg; Trp at position 6 is substituted by Ala; Val at position 7 by Ser; Lys at position 8 by Glu; Gln at position 9 by Ala; Lys at position 13 by Glu; and Ser at position 14 by Ala; and deletion analogs thereof in which up to 5 amino acid residues are deleted from the C-terminal of peptide IVa. [0063] (v) Peptide Va of the formula: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Y Y C A R S G R Y G  N  Y  W  G  Q  G  T  L (V) [0064] and substitution analogs thereof in which Ser at position 6 is substituted by Phe; Gly at position 7 is substituted by Ala; Arg at position 8 is substituted by either Ala or Glu; Asn at position 1 is substituted by Asp; Tyr at position 12 by Phe; and Trp at position 13 by either His or Ala; and deletion analogs thereof in which up to 5 amino acid residues are deleted from the C-terminal of peptide Va. [0065] Once an analog in accordance with the present invention is produced, its ability to inhibit the proliferative response of T lymphocytes of mice that are high responders to SLE-inducing autoantibodies may be readily determined by those of ordinary skill in the art without undue experimentation using tests such as those described herein. One test which may be readily conducted is for the ability of substituted peptides to inhibit in vitro the proliferative responses of certain T cell lines and clones specific to SLE-inducing autoantibodies. The T cell lines and clones may, for example, be the T cell lines and clones specific to the 16/6 Id mAb (Fricke et al., 1991) established from immunized lymph node cells of mice by previously described methodology (Axelrod and Mozes, 1986). Cells are exposed to the stimulating antibody presented on irradiated syngeneic spleen cells in the presence of enriched medium every two weeks. The T cell lines are cloned by the standard limiting dilution technique.The proliferative responses of these T cell lines and clones are tested, for example, by the method described in Materials and Methods, section (g), herein. [0066] Another test which can be conducted in order to select analogs having the desired activity is to test for the ability of the substituted peptides to inhibit the ability of the T cell lines and clones to provide help to peptide-specific B cells in the presence of the parent peptide. The substituted peptides may also be tested for their ability to bind directly, following biotinylation, to MHC Class II products on antigen-presenting cells of the relevant strains. For this purpose, N-terminal biotinylation of the relevant peptides is performed at 0° C. with an excess of biotin-N-hydroxysuccinimide in aqueous solution (Mozes et al., 1989). Mouse splenic adherent cells or human peripheral blood lymphocyte (PBL)-adherent cells (1×10 6 /sample) are incubated with biotinylated peptides in PBS containing 0.1% bovine serum albumin (PBS/BSA) at 37° C. for 20 hr, followed by incubation with phycoerythrin-streptavidin for 30 min at 4° C. After each incubation, the cells are washed twice with the above solution. Thereafter, the cells are analyzed by flow cytometry using FACScan. In each analysis, a minimum of 5000 cells are examined (for above procedures, see, for example, Mozes et al., 1989; Zisman et al., 1991). [0067] A further test which can be conducted is to test for the ability of the analogs to inhibit cytokine secretion by the T cell line or by T lymphocytes oh lymph nodes of mice that are high responders to SLE-inducing autoantibodies. The cytokines are detected as follows: IL-1 activity is assessed either by ELISA using a pair of capture and detecting antibodies (as described below for IL-4, IL-6, IL-10) or using the LBRM-33(1A5) assay (Conlon, 1983) in which 1A5 cells are stimulated in the presence of phytohemagglutinin (PHA), with either supernatants or recombinant IL-1 at various concentrations to secrete IL-2. Following an overnight incubation, supernatants of 1A5 cells are transferred to the IL-2 dependent cytotoxic T lymphocyte (CTLL) line. Stimulation of the CTLL line by IL-2 is measured after 24 hr by incorporation of 3 [H]-thymidine. IL-2 is directly detected using the IL-2 dependent CTLL line or by ELISA. Levels of IL-4, IL-6, IL-10, INFγ and TNFα in the supernatants are determined by ELISA using antibodies to the various cytokines (Phamingen, San Diego, Calif., USA) according to the manufacturers instructions. [0068] Peptides which test positive in one or more of these in vitro tests will provide a reasonable expectation of in vivo activity. However, in vivo tests can also be conducted without undue experimentation. Thus, for example, adult mice may be injected with the candidate peptide at either day −3 or day 0. The mice are then immunized with the disease-inducing autoantibody or with the peptide. Ten days later, lymph node cells of the mice are tested for their ability to proliferate to the immunogen in order to find out the inhibitory capacity of the candidate peptide. [0069] Another such in vivo animal test consists in measuring the therapeutic activity directly in the murine model in vivo for the production of SLE as described above. The peptides can be injected into the mice in which experimental SLE is induced by different routes at different dosages and at different time schedules. In order to determine the pharmnacokinetic parameters of the analogs, including volume of distribution, uptake into antigen-presenting cells and clearance, one can use biotinylated derivatives of the analogs. The concentration of the soluble fraction of the analogs in the various body fluids can be determined by ELISA, using avidin-coated plates and specific anti-peptide antibodies. Cell bound analogs can be analyzed by FACS, using fluorochromo-conjugated avidin or streptavidin. Furthermore, the treated mice can be tested periodically in order to determine the effect of the peptides on the autoantibody responses and on disease manifestations elicited in the mice by the SLE-inducing autoantibody. [0070] Another in vivo procedure consists in tolerizing newborn mice with the candidate peptide followed by immunization of the mice with the pathogenic autoantibody, such as 16/6 Id+, or with the same peptide, and following the disease manifestations, such as serological findings associated with leukopenia, elevated erythrocyte sedimentation rate, proteinuria, abundance of immune complexes in the kidneys and sclerosis of the glomeruli. [0071] It can thus be seen that, besides the preferred embodiments which have been shown to be operable in the examples herein, those of ordinary skill in the art will be able to determine additional analogs which will also be operable following the guidelines presented herein without undue experimentation. [0072] A relatively simple in vitro test can also be conducted in order to assay for the expected therapeutic efficacy of any given substituted peptide on any given SLE patient. In order to assess the ultimate goal of producing peptides that will bind with high affinity to the appropriate MHC Class II molecules but will not lead to further activation of T cells and will therefore have a therapeutic effect on SLE patients, the peptides may be assayed, following biotinylation, for their ability to bind directly to HLA Class II products on antigen-presenting cells in the peripheral blood lymphocytes of the SLE patients. Healthy control donors and control peptides may be used in such assays to verify their specificity. [0073] A preferred form of the therapeutic agent of the invention is a peptide selected from the group of peptides of formulas I to V herein, including peptides Ia to Va and substitution and/or deletion analogs thereof. [0074] Another preferred form of the therapeutic agent in accordance with the present invention is the form of a multi-epitope single peptide. Thus, in a preferred embodiment, dual petides consisting of two different peptides selected from the group of peptides of formula 1-V herein, are covalently linked to one another, such as by a short stretch of alanine residues or by a putative site for proteolysis by cathepsin. See, for example, U.S. Pat. No. 5,126,249 and European Patent 495,049 with respect to such sites. This will induce site-specific proteolysis of the preferred form into the two desired analogs. Alternatively, a number of the same or different peptides of the present invention may be formed into a peptide polymer, such as, for example, polymerization of the peptides with a suitable polymerization agent, such as 0.1% glutaraldehyde (Audibert et al. (1981), Nature 289:593). The polymer will preferably contain from 5 to 20 peptide residues. Such peptide polymers may also be formed by crosslinking the peptides or attaching multiple peptides to macromolecular carriers. Suitable macromolecular carriers are, for example, proteins, such as tetanus toxoid, and linear or branched copolymers of amino acids, such as a linear copolymer of L-alanine, L-glutamic acid and L-lysine and a branched copolymer of L-tyrosine, L-glutamic acid, L-alanine and L-lysine (T,G)-A-L-, or multichain poly-DL-alanine (M. Sela et al. 1955 , J. Am. Chem. Soc. 77:6175). The conjugates are obtained, for example, by first coupling the peptide with a water-soluble carbodiimide, such as 1-ethyl-3-(3′-dimethylaminopropyl)carbodiimide hydrochloride, and then performing the conjugation with the macromolecular carrier as described by Muller, G. M. et al. (1982) Proc. Natl. Acad. Sci. USA 79:569. The contents of the coupled peptide in each conjugate are determined by amino acid analysis, in comparison to the composition of the carrier alone. [0075] According to one embodiment of the present invention, one or more active peptides may be attached to a suitable macromolecular carrier or may be polymerized in the presence of glutaraldehyde. [0076] The peptides, polymers thereof or their conjugates with suitable macromolecular carriers, will be given to patients in a form that insures their bioavailability, making them suitable for treatment. If more than one peptide analog is found to have significant inhibitory activity, these analogs will be given to patients in a formulation containing a mixture of the peptides. [0077] The invention further includes pharmaceutical compositions comprising at least one synthetic peptide according to the invention, a conjugate thereof with a suitable macromolecular carrier or a polymer thereof optionally with a pharmaceutically acceptable carrier. [0078] Any suitable route of administration is encompassed by the invention, including oral, intravenous, subcutaneous, intraarticular, intramuscular, inhalation, intranasal, intrathecal, intraperitoneal, intradermal, transdermal or other known routes, including the enteral route. [0079] The dose ranges for the administration of the compositions of the present invention should be large enough to produce the desired effect, whereby, for example, an immune response to the SLE-inducing autoantibody, as measured by T cell proliferation in vitro, is substantially prevented or inhibited, and further, where the disease is significantly treated. The doses should not be so large as to cause adverse side effects, such as unwanted cross reactions, generalized immunosuppression, anaphylactic reactions and the like. [0080] Effective doses of the peptides of this invention for use in treating SLE are in the range of about 1 μg to 100 mg/kg body weight. The dosage administered will be dependent upon the age, sex, health, and weight of the recipient, kind of concurrent treatment, if any, frequency of treatment, and the nature of the effect desired. [0081] The synthetic peptides and analogs of the invention, particularly those of sequences I to V herein, are aimed at inhibiting or suppressing specific antigen responses of SLE patients, without affecting all other immune responses. This approach is of the utmost importance since most diagnosed patients are young women that have to be treated for many years and the currently accepted treatment for SLE involves administration of immuno-suppressive agents, such as corticosteroids and/or cytotoxic drugs, that are both non-specific and have multiple adverse side effects. [0082] The present invention will now be described in more detail in the following non-limiting Examples and the accompanying figures: EXAMPLES Materials and Methods [0083] a) Mice: Mice (BALB/c and SJL/J) were obtained from the Jackson Laboratory, Bar Harbor, Me., USA and from Olac, Show's farm, Bicesper Oxon, England. Mice were used at the age of 6-12 weeks. In some studies neonatal mice were also used. [0084] b) Human mAb 16/6 Id: The human mAb 16/6 is an anti-DNA antibody originally of the IgM isotype and switched in culture to IgGl. The mAb was derived from a patient and expresses a common idiotype, the 16/6 Id (Shoenfeld et al., 1983; Mendlovic et al., 1988). The hybridoma cells secreting this mAb are routinely grown in culture, and the antibody is isolated from culture supernatants using an affinity column of Protein G coupled to Sepharose™. [0085] c) Production of mouse mAb 5G12 and 2C4C2: Experimental SLE was induced in C3H.SW female mice by immunization with the previously described murine anti-16/6 Id mAb (Mendlovic et al., 1989). Four months later, two mice were sacrificed and their spleen cells were fused with X63.653 plasmacytoma cells. Hybridoma cells that secreted autoantibodies were cloned by limiting dilution in 96-well microtiter plates. The sequence characteristics of nine monoclonal autoantibodies secreted by nine of the hybridoma clones were characterized (Waisman and Mozes, 1993). The mAb designated 5G12 and 2C4C2 were isolated and affinity purified from the hybridoma supernatants using a goat anti-mouse Ig-Sepharose™ 4B column. The 5G12 mAb was found to be an anti-DNA mAb that bear the 16/6 Id and have the IgG2a isotype. The 2C4C2 mAb was found to be an anti-DNA and anti-cardiolipin mAb and to be of the IgM isotype. The nucleotide and deduced amino acid sequences for the V H of both 5G12 and2C4C2 mAb are presented in FIG. 1 of Waisman and Mozes, 1993, in which figure the CDR regions are boxed. [0086] d) Induction of experimental SLE in mice: Mice were injected with the human monoclonal 16/6 Id (1 μg/mouse) or the murine 16/6 Id mAb, e.g. mAb 5G12 (20 μg/mouse), in complete Freund's adjuvant in the hind footpads. Three weeks following injection, the mice were boosted with the same amount of the immunizing antibody in phosphate-buffered saline (PBS).The mice were then tested for autoantibody production and clinical manifestations characteristic of experimental SLE. [0087] e) Detection of SLE-associated clinical manifestations: The erythrocyte sedimentation rate was determined by diluting the heparinized blood in PBS at a ratio of 1:1. The diluted blood was then passed to a microsampling pipette and the sedimentation was measured 6 hours later. White blood cell counts were determined after the hemolysis of heparinized blood. Proteinuria was measured in a semi-quantitative manner, using a Combistix kit (Ames, Stoke Poges, Slough, U.K.). Immunohistology was performed by incubation of fixed frozen cryostat sections with FITC-labeled antibodies to mouse Ig. Staining was visualized via use of a fluorescent microscope. [0088] f) Enzyme-linked immunosorbent assay (ELISA): ELISA was utilized for the detection and quantitation of antibodies in experimental mice, and in humans. Polystyrene microtiter plates were coated with the relevant antigen or antibody, and sera dilutions or supernatants derived from the human or mouse cell cultures were added to the blocked plates. Specific binding was determined following the addition of peroxidase-conjugated antibodies against the appropriate immunoglobulin (Ig) (e.g. goat anti-human or goat anti-mouse peroxidase-conjugated antibodies) and the peroxidase substrate. Optical densities were read at 414 nm using an ELISA reader. [0089] g) Proliferative responses of splenic and lymph node cells: Cells (0.5×10 6 /well) derived from the spleen and lymph nodes of treated and untreated mice were cultured in microtiter plates in the presence of different concentrations of the various immunizing pathogenic autoantibodies. At the end of 96 hours incubation, 0.5 μCi of 3 H-thymidine was added for an additional 18 hours, after which cells were harvested and radioactivity was counted. [0090] h) Treatment of experimental mice: In order to either prevent induction of experimental SLE or to cure mice afflicted with the disease, the following procedures were used: (i) Newborn mice were tolerized with a peptide of the invention (100 μg of the peptide in PBS, intraperitoneally at 24 and 72 hours after birth). Six weeks later, the mice were immunized with the pathogenic autoantibody, e.g. 5G12 (16/6 Id+) and examined for disease manifestations; (ii) A first group of adult mice was injected with various concentrations of the peptides before disease induction with the pathogenic autoantibody or pathogenic T cell line; another group was injected with the peptides to be tested for their therapeutic effect six weeks following immunization at the peak of the serological response; and a further group was treated at 4-6 months post-immunization after the establishment of the overt SLE disease. The number of injections with the peptides was determined based on their effect on the disease induction and progression. The effect of the peptide treatment on T cell proliferation, on the autoantibody production and on the disease manifestations was then evaluated. [0091] i) Proliferative responses of T cell lines and clones: T cell lines and clones specific to the 16/6 Id were established from immunized lymph node cells as previously described (Axelrod and Mozes, 1986). Cells were exposed to the stimulating antibody presented on irradiated syngeneic spleen cells in the presence of enriched medium every two weeks. The T cell lines were cloned by the limiting dilution technique. Cells (10 4 /well) were cultured with 0.5×10 6 irradiated (3000 rad) syngeneic spleen cells in the presence of different concentrations of either the specific stimulator of the line or control reagents. At the end of 48 hours incubation, 0.5 μCi of 3 H-thymidine were added for an additional 18 hours, after which cells were harvested and radioactivity was counted. [0092] j) Proliferation and cytokine production by peripheral blood lymphocytes (PBL): PBL from human SLE patients and of the appropriate control donors (2×10 5 /well) were cultured in microtiter plates in enriched medium containing 10% pooled AB sera in the presence of the human or mouse monoclonal 16/6Id antibody, in the presence of peptides of the invention or in the presence of phytohemagglutinin (PHA). The rate of proliferation was evaluated by the incorporation of 3 [H]-thymidine in the cell culture. Non-relevant peptides were used as specificity controls. Antigen and mitogen-stimulated cytokine production was quantitated in the supernatants of the above cultures using either the cytokine-dependent lines or the appropriate pairs of antibodies in ELISA assays. Inhibition of the proliferative responses was performed iii vitro by adding increasing doses of the tested peptide analogs into the proliferative culture mixtures. [0093] k) Human T cell lines and clones: Human T cell lines specific to the 16/6Id may be established from PBL of either SLE patients or controls following stimulation in vitro with either the human or mouse mAb 16/6 Id or the peptides. The maintenance and cloning of the lines was performed similarly to that described above for the murine T cell lines, with the exception that the stimulation was performed using either autologous irradiated cells or EBV-transformed lines of autologous PBL (used as antigen-presenting cells). [0094] l) Biotinylation of peptides: N-terminal biotinylation of the peptides was performed in 0.1N sodium bicarbonate solution at room temperature, with excess of biotinamnidocaproate N-hydroxysuccinimide ester (Sigma, St. Louis, Mo.) dissolved in 1-methyl-2-pyrrolidone (Sigma). [0095] m) Direct binding of biotinylated peptides to APC: Spleen cells suspended in RPMI 1640 medium containing 10% FCS were incubated in Petri dishes for 60 min at 37° C. Thereafter, non-adherent cells were removed, the plates were washed, and the adherent cells were collected from the plates using a rubber policeman (Costar, Mass., USA). These cells (1×10 6 /100 μl/tube) were incubated with the biotinylated peptides in PBS containing 0.1% BSA (high purity grade, Amresco, Ohio, USA) for 16 hr at 37° C., followed by incubation with phycoerythrin (PE)-streptavidin (Jackson ImmunoResearch) for 30 min at 4° C. Thereafter the samples were incubated with biotinylated anti-streptavidin (1:60, Vector Laboratories, Burlingame, Calif.) and for an additional period with PE-streptavidin, all for 30 min at 4° C. The cells were washed twice with cold PBS/BSA solution after each incubation. Thereafter, cells were analyzed by flow cytometry using the FACSort cytometer and CELLQuest software (Beckton-Dickinson, Mountain View, Calif.). Three antibodies were used for inhibition of binding in these experiments: 34-5-3 (anti-I-A b , Pharmingen, San Diego, Calif.); MKD6 (anti-I-A d , Beckton-Dickinson) and 10.3.6.2 (anti-I-A s (Zamvil et al., 1988)). Example 1 Synthesis of the Peptides [0096] The synthetic peptides of the invention of the formulas Ia, IIa and IIIa herein as well as control peptides were prepared with an automated synthesizer (Applied Biosystem model 430A, Germany) using the manufacturer's protocols for t-butyloxycarbonyl (BOC) procedure (see Kent et al., 1984; Schnolzer et al., 1992). Briefly, in this procedure, commercially available side-chain protected amino acids were used, the amino acids being added at each step with at least 99% efficiency. The protecting groups were removed from the peptides and were cleared from the resin with anhydrous HF. Subsequently, the peptides were purified by extraction with ethyl acetate or isopropyl acetate and by HPLC. The purity of the peptides Ia, IIa and IIIa so obtained was then verified by HPLC and amino acid analysis. [0097] For the preparation of peptides IVa and Va herein and analogs of the peptides Ia to Va of the invention, the same procedure as noted above may be used. [0098] The peptides Ia, IIa and IIIa were then analyzed for their biological activity and other characteristics as set forth in Examples 2-14 below. It is to be understood that the other peptides not so-tested may be subjected to the same analysis. Example 2 Detection of Anti-DNA Antibodies in the Sera of Mice Immunized with Peptides Ia and IIIa [0099] SJL/J and BALB/c female mice (6-8 week old) were immunized with 20 μg of peptide Ia or IIIa of the invention, or with a control peptide designated p278 (the peptide designated Pep 278h described in published PCT International Application WO 94/03208) or with mAb 5G12 emulsified in complete Freund's adjuvant (CFA) in the foot pads. Three weeks later the mice received a booster injection with the same amount of peptide or mAb, in PBS. Thereafter, blood was drawn every two weeks. A fifth group included non-immunized mice. [0100] [0100]FIG. 1 depicts the anti-DNA antibodies in the sera of mice three months after the booster injection, and is very similar to the amount of the autoantibodies produced in later periods. [0101] As shown in FIG. 1A, SJL/J mice that were immunized with the peptide IIIa (open circles) show a high level of anti-DNA antibodies, that is higher than that of mice immunized with the whole antibody 5G12 (open boxes). Low levels of anti-DNA antibodies were observed in the sera of SJL/J mice immunized with either the peptide Ia (open diamonds), control peptide p278 (open triangles) or normal non-immunized mice (crossed square). [0102] As shown in FIG. 1B, BALB/c mice that were immunized either with the whole antibody 5G12 (open boxes) or the peptide Ia (open diamonds) show presence of anti-DNA antibodies in the sera. However, sera of BALB/c mice immunized with either the peptide IIIa (open circles), p278 (open triangles) or normal non-immunized mice (crossed square) did not show presence of anti-DNA antibodies. [0103] ELISA was utilized to test the presence of the anti-DNA antibodies in the sera of the mice, as follows: Plates (Nunc) were coated for 90 min with 10 μg/ml of methylated BSA. Thereafter the plates were washed (all the washes were 3 times with PBS/0.05% Tween 20 (Sigma)) and incubated for an additional 90 min with 10 μg/ml of single-stranded DNA (calf thymus DNA (Sigma) that was heated for 15 min at 90° C. and fast-cooled). The plates were washed and blocked overnight with 1% ovalbumin in PBS (Sigma). Thereafter, the plates were washed and incubated with the sera of the mice diluted in the blocking reagent, followed by wash and incubation with 1:500 dilution of goat anti-mouse IgG (Fc receptor specific) polyclonal antibody conjugated to peroxidase. The plates were then washed and developed using ABTS substrate (Sigma), and the color was read using an ELISA reader at 414 nm. Results are expressed as mean OD of each mouse group (5 mice per group). Example 3 Detection of Anti-nuclear Extract (NE) Antibodies in the Sera of Mice Immunized with the Peptides Ia and IIIa [0104] Five groups of mice were immunized according to Example 2, and their sera were tested for the presence of anti-NE antibodies. [0105] As shown in FIG. 2A, SJL/J mice immunized with the mAb 5G12 (open squares) or with the peptide IIIa (open circles) produced a high level of anti-NE antibodies, whereas mice immunized with the peptide Ia (open diamonds) or p278 control peptide (open triangles), or normal non-immunized mice (crossed squares), produced lower levels of anti-NE antibodies. [0106] As shown in FIG. 2B, BALB/c mice immunized with the mAb 5G12 (open squares) or with the peptide Ia (open diamonds) produced high levels of anti-NE antibodies, whereas very low level of anti-NE antibodies was detected in the sera of BALB/c mice immunized with the peptide IIIa (open circles). No anti-NE antibodies were detected in the group of mice immunized with p278 control peptide (open triangles) or in normal non-immunized mice (crossed squares). [0107] ELISA was utilized to test the presence of the anti-NE antibodies in the sera of the mice, as follows: Plates (Nunc) were coated with 5 μg/ml of of HeLa cells NE for 90 min. Thereafter plates were washed and blocked, and ELISA was continued the next day, as described in Example 2 for anti-DNA antibodies. Example 4 Detection of Anti-RNP, Sm, Ro and La Antibodies in the Sera of Mice Immunized with the Peptides Ia and IIIa [0108] The same sera of the mice as described in Examples 2 and 3 were used for detection of anti-RNP, Sm, Ro and La antibodies. [0109] As shown in FIG. 3A, SJL/J mice immunized with the peptide IIIa (lined box) produced extremely high levels of anti-Ro autoantibodies, antibodies that are typical for SLE in humans. High levels of anti-RNP, anti-Sm and anti-La antibodies were detected not only in SJL/J mice immunized with the peptide IIIa (lined box), but also with the peptide Ia (closed box), as compared to normal mice (open box) or to mice immunized with the control peptide p278 (dotted box). [0110] As shown in FIG. 3B, BALB/c mice immunized with the peptide Ia (closed box) or the peptide IIIa (lined box) produced very high levels of anti-RNP antibodies. However, BALB/c mice immunized with the peptide IIIa (lined box) showed very low levels of anti-Sm, anti-La and anti-Ro antibodies, as compared to BALB/c mice immunized with the peptide Ia (closed box) which produced detectable antibodies in the sera. [0111] Plates were purchased as pre-coated plates and were blocked with 1% ovalbumin in PBS for 2 hr. Thereafter the plates were washed as in Example 2 above, incubated in duplicates with 1:10 diluted sera, washed again and ELISA was carried out as described in Example 2 above. Example 5 Clinical Manifestations of SLE in Mice Immunized with the Peptides Ia and IIIa [0112] BALB/c and SJL mice were immunized with mAb 5G12 or with peptides Ia and IIIa, and five months later were checked by two criteria for manifestation of SLE: white blood cell count (WBC) and proteinuria. [0113] (i) White blood cell count (WBC): The mice were bled, their blood was diluted 1:10 with 1% (vol/vol) acetic acid in order to eliminate the red blood cells, and white blood cells were counted under a normal light microscope. [0114] Proteinuria: The urine of the mice was tested using combisticks (Combistix Kit, Ames) for the presence of protein. High levels of protein in the urine are indicative of kidney damage, a typical manifestation of SLE. TABLE 1 Clinical manifestations of mice immunized with the peptides Immu- BALB/c BALB/c SJL nization W.B.C. a proteinuria b SJL W.B.C. a proteinuria b mAb 5G12 3800 ± 400 0.975 ± 0.08 Nd c  0.8 ± 0.07 pep Ia 3375 ± 350 0.88 ± 0.076 Nd c 0.375 ± 0.04 pep IIIa 3325 ± 400 0.30 ± 0.01 3300 ± 1343  0.9 ± 0.075 p278 6470 ± 920 0.33 ± 0.02 7150 ± 320  0.2 ± 0.25 non- 6800 ± 1200  0.1 ± 0 8100 ± 475  0.5 ± 0 immunized [0115] The results for both WBC and proteinuria are shown in Table 1: Mice immunized with either the mAb 5G12 or the peptides Ia or IIIa had a lower number of white blood cells in comparison to non-immunized mice or those immunized with p278 control peptide. High levels of protein were measured in the urine of both BALB/c and SJL mice immunized with mAb 5G12, of SJL mice immunized with the IIIa peptide and of BALB/c mice immunized with the Ia peptide, while a smaller increase in protein level was detected in the urine of both mice immunized with control peptide p278, of IIIa-immunized BALB/c mice anf of Ia-immunized SJL mice. Example 6 Specificity of Mice Response to the Peptides [0116] As shown in previous examples, the peptides Ia and IIIa were used for the immunization of different mouse strains, in parallel to their immunization with the whole monoclonal antibody. The draining lymph nodes of the mice proliferated to the immunizing peptides to different extents, depending on the mouse strains. Thus, BALB/c mice were found to be high responders to peptide Ia, whereas SJL mice were found to be high responders to peptide IIIa. Both peptides were used in attempts to induce experimental SLE using the protocol utilized for the pathogenic autoantibodies. It was found that SJL mice that were immunized with peptide IIIa and BALB/c mice that were immunized with peptide Ia produced elevated levels of autoantibodies including anti-DNA (see FIG. 1) and anti-NE antibodies (see FIG. 2). Moreover, the immunized mice developed leukopenia and proteinuria (see Table 1) similarly to mice in which experimental SLE has been induced using the murine anti-DNA, 16/6Id+ pathogenic 5G12 mAb. Kidney analysis of the peptide-injected mice revealed mild immune complex deposits in part of the mice. These results indicate that peptides Ia and IIIa are important T cell epitopes of the whole molecule of the pathogenic autoantibody. [0117] In order to assess the correlation between the peptides of the invention and T cells, a T cell line specific to peptide IIIa of SJL origin (high responders to the peptide IIIa) was established. The T cells of the line proliferated specifically to the peptide IIIa but not to non-relevant control peptide p278, and upon stimulation with peptide IIIa, secreted the Thi-type cytokines, namely, IL-2, IFNγ and TNFα. Injection of the T cell line into syngeneic healthy mice led to the production of autoantibodies and development of clinical manifestations that are characteristic to mice with experimental SLE. These results confirm the role of the CDR-based peptides of the invention in experimental SLE and demonstrate the role of the peptide-specific T cells in the autoimmune disease. Example 7 Detection of Anti-DNA and Anti-NE Antibodies in the Sera of BALB/c Mice Tolerized with the Peptide Ia and Immunized with Either Peptide Ia or mAb 5G12 [0118] In order to further elucidate the role of the peptides in SLE, peptide Ia was utilized for the induction of tolerance in BALB/c mice. Newborn mice were injected twice (at day 1 and 3) with either peptide Ia or a control peptide. Thus, neonatal BALB/c mice, 24 hr old, were injected intraperitoneally (i.p.) with 100 μg of the peptide Ia or the control peptide p307 (a peptide related to myasthenia gravis described in published PCT Application No. WO 94/00148) in PBS, and received a second injection 48 hr later with the same amount of peptide. Six to seven weeks after injection, the mice were immunized as described in Example 2 above with either the mAb 5G12 or the peptide Ia. The mice were bled two weeks after boost (and then periodically every two weeks) and the sera of the mice were tested for the presence of anti-DNA or anti-NE antibodies, as described in Examples 1 and 2 above. The assays performed to measure these autoantibody titers in the sera of the experimental mice indicated that the mice that were tolerized with peptide Ia did not produce significant titers of antibodies to either DNA or nuclear extract antigens, whereas mice tolerized to the control peptide p307 prior to their immunization with peptide Ia or the mAb 5G12 produced high autoantibody titers. [0119] As shown in FIGS. 4 A-B, BALB/c mice that were either tolerized with the peptide Ia and then immunized with the mAb 5G12 (half-filled squares), or tolerized with the peptide Ia and then immunized with the same peptide Ia (filled squares) produced lower levels of anti-DNA and anti-NE antibodies in comparison with mice that were tolerized with the non-relevant peptide p307 and then immunized with the mAb 5G12 (filled triangles), or tolerized with peptide 307 and then immunized with peptide Ia (filled circles). [0120] This indicates that neonatal tolerization with the peptide Ia could lower the levels of autoantibodies in the sera of mice later immunized with the peptide Ia or the mAb 5G12. Example 8 In vivo Inhibition of Lymph Node Cell (LNC) Proliferation Responses to the CDR-based Peptides Ia and IIIa [0121] BALB/c (FIG. 5 a ) and SJL (FIG. 5 b ) mice were immunized with peptides Ia and IIIa (20 μg/mouse in CFA i.d. in the hind footpads), respectively. The mice were also injected i.v. with 200 μg of the above peptides in PBS either 3 days prior to immunization (open squares), at the immunization day (open circles) or at both dates (open triangles). Ten days later the mice were sacrificed and their lymph nodes were removed and tested for proliferation in the presence of different concentrations of the immunizing peptide. Control groups were of LNC taken from mice that were immunized but not treated (filled squares), or treated with control peptide, p307 (half filled squares). The culture mixtures were incubated for 96 hours in enriched RPMI medium containing 1% normal mouse serum prior to addition of 3 H-thymidine. Sixteen hours later cells were harvested and radioactivity was counted. Results are expressed as mean CPM of triplicates. SD values did not exceed 10%. [0122] As shown in FIGS. 5 a - b , both peptides Ia ( 5 a ) and IIIa ( 5 b ) inhibited proliferative responses of LNC of BALB/c and SJL mice, respectively, when injected to the mice either 3 days prior to, or at the immunization day: Up to 95% of the proliferative capacity of the cells was inhibited by the peptides.The inhibition was specific since the proliferative responses of the LNC to Con A were not inhibited by peptides Ia and IIIa (not shown). Example 9 In vivo Inhibition of LNC Proliferation of Mice Immunized with mAb 5G12 and Treated with Peptides Ia and IIIa [0123] BALB/c (FIG. 6 a ) and SJL (FIG. 6 b ) mice were immunized with mAb 5G12 (20 μg/mouse in CFA i.d. in the hind footpads) and were injected (200 μg/mouse i.v. in PBS) with either peptide Ia or IIIa, respectively. Proliferation responses to mAb 5G12 were measured in LNC taken from mice that were immunized and not treated (filled squares), treated concomitantly with immunization with the control peptide p307 (half filled squares) or treated with the appropriate CDR-based peptide Ia ( 6 a ) or IIIa ( 6 b ) (open squares). Proliferation responses to the immunodominant CDR-based peptide Ia and IIIa was also monitored in LNC taken from non-treated mice (filled circles) or from mice treated with the appropriate CDR-based peptide Ia or IIIa (open circles). Results are expressed as mean CPM of triplicates. SD values did not exceed 10%. [0124] As shown in FIGS. 6 a - b , proliferative responses to mAb 5G12 of LNC taken from mice treated with the appropriate CDR-based peptide were inhibited comparing to the responses of non-treated mice. Example 10 In vivo Inhibition of LNC Proliferation to the Human Monoclonal Anti-DNA 16/6Id Antibody [0125] BALB/c (FIG. 7 a ) and SJL (FIG. 7 b ) mice were immunized with human mAb 16/6Id (1 μg/mouse in CFA i.d. in the hind footpads) and were injected (200 μg/mouse i.v. in PBS) with either peptide Ia or IIIa, respectively. Proliferation responses to mAb 16/6Id were measured in LNC taken from immunized but not-treated mice (filled squares), from mice treated concomitantly with immunization with the control peptide p307 (half filled squares) or from mice treated with the appropriate CDR-based peptide Ia or IIIa (open squares). Proliferation responses were also shown to the immunodominant CDR-based peptide Ia or IIIa of LNC taken from 16/6Id immunized non-treated mice (filled circles) or from mice treated with the appropriate CDR-based peptide Ia or IIIa (open circles). Results are expressed as mean CPM of triplicates. SD values did not exceed 10%. [0126] As shown in FIGS. 7 a - b , proliferative responses to mAb 16/6Id of LNC taken from mice treated with the appropriate CDR-based peptide Ia or IIIa were inhibited comparing to the responses of immunized but not treated mice, or mice treated with the control peptide p307. Example 11 Binding of CDR-based Peptides Ia and IIIa to the Surface of Splenic Antigen-presenting Cells (APC) [0127] Splenic adherent cells (10 6 /100 μl/tube) isolated from BALB/c, SJL, C3H.SW or C57BL/6 mice were incubated for 16 hours with biotinylated CDR-based peptide Ia or IIIa followed by incubation with PE-streptavidin for 30 min at 4° C. Thereafter the samples were incubated with biotinylated anti-streptavidin and for an additional period with PE-streptavidin, all at 4° C. for 30 min. After washing, the cells were analysed by flow cytometry using the FACSort cytometer and CELLQuest software. [0128] The results are shown in FIG. 8: staining of cells that were incubated with the biotinylated CDR-based peptides is marked by solid lines, and background staining with non-biotinylated peptide is marked by broken lines. Splenic antigen-presenting cells derived from all tested mouse strains (except for C57BL/6 mice that are resistant to induction of SLE) showed significant binding of both CDR-based peptides Ia and IIIa to MHC class II products, indicating that their binding capacity agrees with the susceptibility of the mouse strains to SLE induction. [0129] Binding of the CDR-based peptides Ia and IIIa to APC was determined as described in Materials and Methods herein and the results are shown in Table 2. Binding percentage was about 38-53% for all strains, except for APC from C57BL/6 strain which showed only 19.3% and 8.5% binding with peptides Ia and IIIa, respectively The binding was inhibited by the relevant anti-Ia antibodies showing the specificity of the binding to MHC Class II products. The results are shown in Table 3: Inhibition of binding was specific and ranged from 60% to 100%. TABLE 2 Binding of peptides Ia and IIIa to APC of mice Mouse strain H-2 a peptide % binding BALB/c d Ia 45.7 BALB/c d IIIa 41.3 SJL s Ia 42.3 SJL s IIIa 38.0 C3H.SW b Ia 42.3 C3H.SW b IIIa 52.9 C57BL/6 b Ia 19.3 C57BL/6 b IIIa 8.5 [0130] [0130] TABLE 3 Inhibition of binding of peptides Ia and IIIa to APC by anti-Ia mAb % inhibition Mouse strain H-2 mAb pep Ia pep IIIa BALB/c d anti I-A d (MKD6) 76.7 100 BALB/c d anti I-A b (34-5-3) 0 0 SJL s anti I-A s (10.3.6.2) 100 92.8 SJL s anti I-A d (MKD6) 0 0 C3H.SW b anti I-A b (34-5-3) 60 84.4 C3H.SW b anti I-A d (MKD6) 0 25 C57BL/6 b anti I-A b (34-5-3) 82 59.3 C57BL/6 b anti I-A d (MKD6) 0 0 Example 12 Detection of Antibodies Against Peptides Ia, IIa and IIIa, and Anti-16/6 Id Antibodies in the Sera of SLE Patients and Healthy Controls [0131] Human SLE patients (32 patients) were bled and their sera were tested by ELISA for their ability to bind the peptides Ia, IIa and IIIa, a control peptide p195-212 (a myasthogenic peptide described in PCT publication No. WO 94/00148) or mAb 5G12. [0132] Detection of the antibodies was conducted on plates that were coated with 10 μg/ml of peptides Ia, IIa, IIIa or p195-212 or mAb 5G12, in PBS for 2 hr, washed and blocked with 1% ovalbumin in PBS for an additional 2 hr. ELISA was continued as described after blockage in Example 2 above, using goat anti-human IgG polyclonal antibody conjugated to peroxidase. [0133] As shown in FIG. 9, SLE patients exhibited significantly higher levels of antibodies that bind either peptide Ia (open squares), IIa (open diamonds) or IIIa (open circles), or mAb 5G12 (open triangles), in comparison to healthy controls (peptide Ia-healthy—closed diamonds; peptide IIa-healthy—crossed circles; peptide IIIa-healthy—inverted open triangles; 5G12-healthy—half filled squares). No binding could be observed when either sera of patients or controls were tested on plates coated with the non-relevant peptide p195-212 (p195-212-SLE—crossed squares; p195-212-healthy—half filled diamonds). The results indicate a correlation between the whole antibody molecule and the CDR-based peptides on the level of antibody titers. Example 13 Proliferation of PBL from SLE Patients and Healthy Controls in the Presence of Human 16/6 Id mAb and Peptides [0134] Peripheral blood lymphocytes (PBL) were isolated from the blood of SLE patients or healthy controls using ficol gradient. Thereafter, the PBL were incubated in the presence of different concentrations of the peptides Ia, IIa or IIIa, or the human 16/6 Id mAb for 24 hr, when a sample was taken for IL-2 measurement. The assay was continued for a total of 7 days, and 3 H-thymidine was added for the last 16 hr. Proliferation was detected by reading the amount of radioactivity incorporated into the DNA of the cells. [0135] As is seen in Table 4, a lower proportion of the PBL taken from SLE patients reacted to the peptides or to the 16/6 Id mAb, when compared to the healthy controls.The results are expressed in percentage of responder (34% in the first line) and the actual number of patients (11 out of 32: 11/32) [0136] Similar results were obtained when the levels of the IL-2 produced by the PBL in the presence of the peptides or the 16/6 Id mAb were tested, as shown in the next example. TABLE 4 Proliferation of PBL from SLE Patients and Healthy Controls in Presence of mAb 16/6 Id and Peptides Ia-IIIa SLE Healthy Patients Controls 16/6 Id 34% 11/32 72% 18/25 pep Ia 21%  7/32 44% 11/25 pep IIa 9%  3/32 28%  7/25 pep IIIa 31% 10/32 60% 15/25 Example 14 Production of IL-2 by PBL of SLE Patients and Healthy Controls in the Presence of Human mAb 16/6 Id and Peptides [0137] PBL were isolated from blood of SLE patients or healthy controls using ficol gradient, and were incubated as in Example 13. A sample of 50 μl was removed 24 hr after the assay was started, and incubated in the presence of IL-2 sensitive cells (CTLD) for 24 hr, after which 3 H-thymidine was added for 16 hr, and the plates were harvested and counted on a beta counter. [0138] As in Table 4, it can also be seen from Table 5 that a lower proportion of the PBL taken from SLE patients reacted to the peptides or to the 16/6 Id mAb, when compared to the healthy controls, thus indicating that the response to the peptide corresponds to that of T cells of the patient to the pathogenic human autoantibody. TABLE 5 IL-2 Production by PBL of SLE Patients and Healthy Controls in Presence of mAb 16/6 Id and Peptides Ia-IIIa SLE Healthy Patients Controls 16/6 Id 31% 10/32  66% 17/25 pep Ia 16% 5/32 56% 14/25 pep IIa 9% 3/32 32%  8/25 pep IIIa 16% 5/32 64% 16/25 References [0139] 1. Axelrod, O. and Mozes, E. Immunobiology 172: 99, 1986. [0140] 2. Conlon, P. J. J. Immunol. 134:1280, 1983. [0141] 3. Fricke, H., Offen, D., Mendlovic, S., Shoenfeld, Y., Bakimer, R, Sperling, J. and Mozes, E. Internatl. Immunol. 2: 225, 1990. [0142] 4. Fricke, H., Mendlovic, S., Blank, M., Shoenfeld, Y., Ben-Bassat, M. and Mozes, E. Immunology 73: 421, 1991. [0143] 5. Mendlovic, S., Brocke, S., Shoenfeld, Y., Ben-Bassat, M., Meshorer, A., Bakimer, R. and Mozes, E. E. Proc. Natl. Acad. Sci. USA 85: 2260, 1988. [0144] 6. Mendlovic, S., Fricke, H., Shoenfeld, Y. and Mozes E. Eur. J. Immunol. 19: 729, 1989. [0145] 7. Mendlovic, S., Brocke, S., Fricke, H., Shoenfeld, Y., Bakimer, R. and Mozes, E. Immunology 69: 228, 1990. [0146] 8. Mozes, E., Dayan, M., Zisman, E., Brocke, S., Licht, A. and Pecht, I. EMBO J. 8: 4049, 1989. [0147] 9. Ruiz, P. J., Zinger, H. and Mozes, E. Immunol. Lett. 41: 79, 1994. [0148] 10. Shoenfeld, Y., Isenberg, D. A., Rauch, J., Madaio, M. P., Stollar, B. D. and Schwartz, R. S. J. Exp. Med. 158: 718, 1983. [0149] 11. Sthoeger, Z. M., Tartakovsky, B., Bentwich, Z. and Mozes, E. J. Clin. Immunol. 13: 127, 1993. [0150] 12. Waisman, A., Mendlovic, S., Ruiz, P. J., Zinger, H., Meshorer, A. and Mozes, E. Internal. Immunol. 5: 1293, 1993. [0151] 13. Waisman, A. and Mozes, E. Eur. J. Immunol. 23: 1566, 1993. [0152] 14. Zisman, E., Sela. M. and Mozes. E. Proc. Natl. Acad. Sci. USA 88: 9738, 1991. [0153] 15. Zamvil et al., J. Exp. Med. 167:1586, 1988. 1 10 20 amino acids amino acid single linear peptide /note= Xaa in position 5 is Met, Ala or Val; Xaa in position 6 is Gln, Asp, Glu, or Arg; Xaa in position 7 is Trp or Ala; Xaa in position 8 is Val or Ser; and Xaa in position 9 is Lys, Glu or Ala. 1 Thr Gly Tyr Tyr Xaa Xaa Xaa Xaa Xaa Gln Ser Pro Glu Lys Ser Le 1 5 10 15 Glu Trp Ile Gly 20 20 amino acids amino acid single linear peptide /note= Xaa in position 9 is Thr, Val or Ala; Xaa in position 10 is Thr, Val or Ala; Xaa in position 11 is Tyr or Phe; Xaa in position 12 is Asn or Asp; Xaa in position 13 is Gln or Glu; Xaa in position 14 is Lys or Glu; and Xaa in position 15 is Phe or Tyr. 2 Glu Ile Asn Pro Ser Thr Gly Gly Xaa Xaa Xaa Xaa Xaa Xaa Xaa Ly 1 5 10 15 Ala Lys Ala Thr 20 20 amino acids amino acid single linear peptide /note= Xaa in position 6 is Phe, Thr or Gly; Xaa in position 7 is Leu, Ala or Ser; Xaa in position 8 is Trp or Ala; Xaa in position 9 is Glu or Lys; Xaa in position 13 is Met or Ala; and Xaa in position 14 is Asp, Lys or Ser. 3 Tyr Tyr Cys Ala Arg Xaa Xaa Xaa Xaa Pro Tyr Ala Xaa Xaa Tyr Tr 1 5 10 15 Gly Gln Gly Ser 20 19 amino acids amino acid single linear peptide /note= Xaa in position 4 is Met or Ala; Xaa in position 5 is Asn, Asp or Arg; Xaa in position 6 is Trp or Ala; Xaa in position 7 is Val or Ser; Xaa in position 8 is Lys or Glu; Xaa in position 9 is Gln or Ala; Xaa in position 13 is Lys or Glu; and Xaa in position 14 is Ser or Ala. 4 Gly Tyr Asn Xaa Xaa Xaa Xaa Xaa Xaa Ser His Gly Xaa Xaa Leu Gl 1 5 10 15 Trp Ile Gly 18 amino acids amino acid single linear peptide /note= Xaa in position 6 is Ser or Phe; Xaa in position 7 is Gly or Ala; Xaa in position 8 is Arg, Ala or Glu; Xaa in position 11 is Asn or Asp; Xaa in position 12 is Tyr or Phe; and Xaa in position 13 is Trp, His or Ala. 5 Tyr Tyr Cys Ala Arg Xaa Xaa Xaa Tyr Gly Xaa Xaa Xaa Gly Gln Gl 1 5 10 15 Thr Leu 20 amino acids amino acid single linear peptide 6 Thr Gly Tyr Tyr Met Gln Trp Val Lys Gln Ser Pro Glu Lys Ser Le 1 5 10 15 Glu Trp Ile Gly 20 20 amino acids amino acid single linear peptide 7 Glu Ile Asn Pro Ser Thr Gly Gly Thr Thr Tyr Asn Gln Lys Phe Ly 1 5 10 15 Ala Lys Ala Thr 20 20 amino acids amino acid single linear peptide 8 Tyr Tyr Cys Ala Arg Phe Leu Trp Glu Pro Tyr Ala Met Asp Tyr Tr 1 5 10 15 Gly Gln Gly Ser 20 19 amino acids amino acid single linear peptide 9 Gly Tyr Asn Met Asn Trp Val Lys Gln Ser His Gly Lys Ser Leu Gl 1 5 10 15 Trp Ile Gly 18 amino acids amino acid single linear peptide 10 Tyr Tyr Cys Ala Arg Ser Gly Arg Tyr Gly Asn Tyr Trp Gly Gln Gl 1 5 10 15 Thr Leu

1a

BACKGROUND OF THE INVENTION [0001] The present invention relates to devices to help minimize medical recovery time, especially devices to help prevent medical errors at the point of service in hospitals, emergency rooms, rehabilitation facilities, and/or nursing homes. [0002] Medical errors are a source of added expense to a nations overall health care costs. Unfortunately, many instances of easily preventable medical errors have been a source of very disturbing news at various times over the last several years. Reducing the number of medical errors should decrease the number of preventable deaths, result in a better quality of life for the patient, and decrease the cost of medical care. [0003] Additionally, medical care can be somewhat rushed because of the emergency nature of some situations and staffing issues in others. It is believed that many hospitals are working with less than optimal nurse staffing, which may often result in short cuts being taken. Saving the nursing staff from having to waste additional time looking up medical information by making it readily available at the point of care can save precious time and also help contribute to the prevention of medical errors. Likewise, saving time in emergency situations by having medical information at the point of service can save the time normally needed to test for information, such as blood type, which both saves time and prevents medical errors. In some cases, the time savings alone may mean the difference between life and death or aiding in creating a better outcome across a range of possible outcomes in a given situation. [0004] Furthermore, patient recovery time can vary according to a number of factors. Some evidence suggests that the spirits of the patient may be one of those factors and many hospitals now allow family and loved ones to spend time with a patient beyond what were traditional visiting hours in the hopes that it would aid in a patients recovery. As many people have experienced, a patient's spirit may be reduced because of some of the factors within a hospital, including being uncomfortable. One unnecessary cause that may make some patients uncomfortable can be the knowledge of the possibility of embarrassment caused by a typical hospital gown that does not provide adequate coverage or that causes people to become exposed too easily by the gaping of material between fasteners. [0005] Therefore, a need exists for an improved system and method to help prevent medical errors by providing commonly needed medical information specific to the patient at the point where care is being provided to such patient. A need further exists for an improved system and method to help prevent medical errors by providing commonly needed medical information that would save the care giver the time needed to look up such information. A further need exists for an improved system and method to help prevent medical errors by providing commonly needed medical information. A further need exists for a patient gown that provides adequate coverage and that closes securely, while still being easily opened, but that does not lend itself to the patient becoming accidentally exposed. A further need exists for a patient gown that is comfortable for the patient to use. DETAILED DESCRIPTION [0006] In one form, the system and method to help prevent medical errors by providing commonly needed medical information provides such information on the hospital garment. [0007] An object of the disclosed invention is the provision of new and improved system and method to help prevent medical errors by providing commonly needed medical information that is provided at the point of medical service by being placed at strategic points on the hospital garment. [0008] Further objects and advantages of the present invention are apparent from the following detailed description made with reference to the accompanying drawings which form a part of the specification and wherein: [0009] FIG. 1 is a front plan view of a form of the invention in the form of a hospital garment; [0010] FIG. 2 is a partial cutaway of the front plan view of the hospital garment of FIG. 1 with the upper right hand pocket removed to show an opening for heart monitor cords or other things; and [0011] FIG. 3 is a back plan view of the hospital garment of FIG. 1 . [0012] It should be noted that the terms patient garment, patient gown, and hospital gown mean the same thing as used throughout this application as they are really one and the same thing. A hospital gown can be utilized in places that are not hospitals, such as doctor's offices and nursing homes. [0013] Referring to FIGS. 1-3 , there is shown one form of a system to help prevent medical errors in the form of hospital gown 10 . In one form, hospital gown 10 can be constructed somewhat similarly to a standard hospital gown. Hospital gown 10 can include a body portion 11 made out of a suitable washable cloth material. Body portion 11 can terminate in neck opening 12 at the top, leg opening 14 at the bottom, and sleeves 20 and 22 on opposite sides of body portion 11 . Sleeves 20 and 22 preferably include arm openings 16 and 18 at their ends opposite body portion 11 . Hospital gown 10 can have a front 24 and a back 26 . [0014] In one form, hospital gown 10 has a body opening 28 in the back 26 that can be opened and closed to allow hospital gown 10 to be easily put on and removed. Hospital gown 10 can also have a body opening 30 in the front 24 that can be opened and closed to allow hospital gown 10 to be easily put on and removed. Such body opening 30 in front 24 can be in addition to, or instead of, body opening 28 in the back 26 . Body openings 28 and 30 also provide the caregiver with any needed access to perform their duties such as listening to the wearer's heart or lungs. [0015] One or more fasteners 32 or 34 can be provided to fasten body openings 28 or 30 in the closed position. In one form, fasteners 32 or 34 can be a single string that is tied together. In another form, fasteners 32 or 34 can be one or more snaps or buttons that can fasten the gown closed. In yet another form, fasteners 32 or 34 can include one or more hook and loop fastener devices, such as VELCRO, that can be used to close gown 10 . In the form depicted, a single hook and loop fastener 32 can be used to form a re-sealable seam to securely fasten the front body opening 30 , for example where the single hook and loop fastener 32 runs along the length of gown 10 from a point proximate to neck opening 12 to an area proximate to leg opening 14 . This form of fastener 32 running all, or most, of the length of gown 10 can aid the wearer's spirits by providing them the confidence of knowing that their gown 10 provides adequate coverage and is unlikely to cause an accidental exposure. [0016] Also in the form depicted, multiple hook and loop fasteners 34 can be used to close gown 10 . Here, the multiple hook and loop fasteners 34 can be placed along the length of gown 10 from a point proximate to neck opening 12 to an area proximate to leg opening 14 . In one form, critical portions of gown 10 at opening 28 can be cut to overlap each other by an amount sufficient to prevent accidental exposure due to the gaping of material between adjacent fasteners 34 . In one form, the overlap can be from 4-12 inches of material that is overlapped. [0017] Similar to more typical hospital gown, additional fasteners 36 and 38 can be provided along the length of sleeves 20 and 22 between the neck opening 12 and arm openings 16 and 18 to close sleeves 16 and 18 while allowing them to be opened when required. In a preferred form. fasteners 36 and 38 can be hook and loop type fasteners. Such fasteners are typically easier to close than the more typical snaps used in many such gowns because they do not need to be as precisely aligned as the snaps require. [0018] In one form, opening 40 is provided on front 24 of gown 10 in an area that is preferably proximate to the heart of the wearer of gown 10 . In a preferred form, opening 40 can be in the form of the depicted slit, which is preferably covered by the outer material 42 that forms chest pocket 50 in a somewhat typical manner. An additional piece of outer material 44 can also be sewn or otherwise securely attached to gown 10 to form an additional chest pocket 52 . In a preferred form, one or more pieces of outer material, such as 46 and 48 , are securely sewn or otherwise attached to gown to form pockets, such as hip pockets 54 and 56 , that are closer to the wearer's hands and more easily reached by the wearer when their arms are down in a normal at rest position. Having pockets much lower on the gown makes it more comfortable because it is more convenient for the wearer to place and retrieve items and also gives them a place to warm their hands if their hands feel a bit chilly. In one form, a second opening is provided on front 24 of gown 10 in an area that is preferably covered by one of the pieces of outer material 46 and 48 that forms hip pockets 54 and 56 . [0019] In a preferred form, gown 10 can be personalized with preselected information concerning the intended wearer that can be very useful to the care giver, especially information (including medical information) that can help prevent medical errors. Such information can include a person's name 58 , blood type 60 , allergies or the absence of any allergies 62 , medical conditions or the lack of any medical conditions 64 , emergency contact information in case something happens to the patient 66 . Additional information could be provided concerning particular procedures that are scheduled, such as identification of a limb to be amputated, identification of a specific artery to be un-blocked, or other information identifying the particulars of a scheduled surgery or other procedure. [0020] In one form, such information can be provided on the front 24 of gown 10 by permanently providing the information on gown 10 . In one form, such information can be embroidered on gown 10 , such as on one or more of the pieces of material 42 , 44 , 46 and 48 that can form pockets 50 , 52 , 54 , and 56 . If the wearer does not own gown 10 , pockets material 42 , 44 , 46 and 48 can be re-moveably attached to the gown, such as by using a hook and look type fastener. However, if the wearer owns gown 10 , such material forming pockets can be securely sewn on and then replaced if the information changes. [0021] Some people may be concerned about keeping their information, including medical information, more private. In such instance, the information can remain covered until needed by a care giver. For example, a privacy screen, in the form of additional material can be provided to cover up such information until needed. Such privacy screen 70 can be re-moveably secured to gown 10 over information 58 - 64 using a hook and loop type fastener along the privacy flaps entire perimeter, or at portions along such perimeter, so that they can be easily removed and/or replaced by the caregiver. Alternatively, such privacy screen can be in the form of a privacy flap 70 , which can be securely sewn to gown 10 , for example, along its top portion 72 closest to neck 12 such that gravity causes the rest of the privacy flap to hang down and cover such medical information. This allows the caregiver to easily move the privacy flap 70 upward in order to view the information underneath. In a preferred form, privacy shield is made from a similar material as the rest of gown 10 and makes the information underneath unreadable or difficult to read at a particular distance. [0022] While gown 10 has been described above as being made from a cloth material, an alternative would be for patient gown 10 to be made out of a disposable material similar to a paper towel, such as a disposable cellulose based material. Such gowns could be of particular use for providing information, including medical information, for a given surgery or other procedures. A marker could even be used to write on the patient gown 10 to identify a particular limb that required amputation or another body part that surgery was going to be performed in order to prevent medical errors. For example, if the patient's right arm needed to be amputated the corresponding right arm 20 of gown 10 could contain information identifying the right arm was to be amputated. Additionally, the left arm 22 of gown 10 might include information indentifying the right arm (or at least not the left arm) was to be amputated. In such case, right arm 20 might have written on it “Amputate this arm” and left arm 22 might have written on it “NOT THIS ONE, THE OTHER ONE”. Alternatively, such information could be provided by the removal of the right arm 20 of gown 10 while keeping left arm 22 intact. [0023] While the present invention has been illustrated and described herein assembled to form a patient gown, it should be apparent from the foregoing that other clothing may be assembled containing similar medical information, for example, pajamas, a nightgown, a bathrobe and other clothing.

1a

TECHNICAL FIELD [0001] The present invention relates to a device for treating a blood circulation canal, of the type comprising: a hollow support delimiting, in the vicinity of a distal end, at least one transverse retention opening; an endoprosthesis which can be deployed between a state retracted against a lateral surface of the support and an expanded state in which the endoprosthesis can be released from the support; at least one filamentary connection forming a clamping ring surrounding the endoprosthesis and forming a loop engaged in the support through the retention opening; the clamping ring being extensible between a configuration for maintaining the endoprosthesis in its retracted state and a configuration for deploying the endoprosthesis; and, for the or each filamentary connection, a retention rod which is mounted to be movable in the support between a position for retaining the loop and a position for releasing the loop. [0007] Such a device is used for releasing in a blood circulation canal endoprostheses of the type commonly referred to by the term “stent”, or endoprostheses of the endovalve type comprising a stent and a valve secured to the stent. BACKGROUND TO THE INVENTION [0008] A device of the above-mentioned type is described in EP-A-0 707 462. In that device, an endoprosthesis is mounted coaxially on two hollow supports capable of sliding relative to each other. The endoprosthesis is maintained in its retracted state by means of two filamentary connections surrounding it at its ends. The filamentary connections are passed into distal and proximal retention openings, respectively, provided in the one and the other of the supports, respectively. The connections are engaged around a retention rod in order to keep them in position at their proximal end. [0009] In order to release the endoprosthesis, the supports are displaced by sliding relative to each other in such a manner that the distance between the retention openings decreases. [0010] The decrease in this distance brings about the loosening of the filamentary connections and consequently the simultaneous deployment of the two ends of the endoprosthesis. [0011] When the positioning of the endoprosthesis in the blood circulation canal is satisfactory, the rod for retaining the filamentary connections is removed from the device. The filamentary connections are then withdrawn from the supports and removed from the patient's body by causing them to slide in the supports. [0012] Bearing in mind the great length of the filamentary connections, and their winding path in the supports, the risk of the filamentary connections becoming jammed or breaking during their withdrawal is high. The reliability of the device is therefore reduced. SUMMARY OF THE INVENTION [0013] The object of the invention is therefore to propose a device for treating a blood circulation canal, which device can be positioned in a precise manner in the vessel while being simple and reliable to use. [0014] To that end, the invention relates to a treatment device of the above-mentioned type, wherein the retention rod comprises at least one hook for retaining the loop, the displacement of the retention rod from its release position to its retention position bringing about the tightening of the clamping ring from its configuration for deploying the endoprosthesis to its configuration for maintaining the endoprosthesis. [0015] The device according to the invention may comprise one or more of the following features, taken in isolation or in accordance with any technically possible combination: the hook is placed at a distal end of the retention rod; the hook delimits, on the retention rod, a distal section of non-zero length and a proximal section, the hook projecting transversely relative to the distal section and to the proximal section; the endoprosthesis delimits, for the or for each filamentary connection, a guide passage for the filamentary connection, the ends of the clamping ring being engaged in the guide passage; the or each filamentary connection is a strand which is closed on itself, the loop being formed by an extension of the clamping ring extending from the guide passage between the ends of the clamping ring; the or each filamentary connection is mounted permanently on the endoprosthesis; the support delimits a proximal retention opening and a distal retention opening, the device comprising, for each retention opening, a separate retention rod comprising a retention hook; the support delimits a proximal retention opening and a distal retention opening, the device comprising a common retention rod comprising a distal hook and a proximal hook; the endoprosthesis is mounted coaxially on the support; the or each filamentary connection is releasable from the endoprosthesis, the retention rod comprising means for retaining at least one retention section of the filamentary connection which is separate from the loop, the section being retained by the retention means when the loop is released from the retention hook, in order to permit the joint displacement of the filamentary connection and the retention rod; and the retention section of the filamentary connection forms an auxiliary loop engaged in the support through a retention opening, the retention rod comprising an auxiliary hook for retaining the auxiliary loop, which hook opens proximally relative to the hook for retaining the loop. [0026] The invention relates also to a process for preparing a device such as described above, before it is implanted in a blood circulation canal, wherein it comprises the following steps: preservation of the endoprosthesis in its expanded state, the or each loop being engaged in a hook of a rod for retaining the loop; displacement of the retention rod from its release position to the position for retaining the loop, in order to bring about the tightening of the clamping ring and to bring the endoprosthesis into its retracted state. BRIEF DESCRIPTION OF THE FIGURES [0029] The invention will be better understood on reading the following description which is given purely by way of example and with reference to the appended drawings in which: [0030] FIG. 1 is a front view of a first treatment device according to the invention, the endoprosthesis being maintained in its retracted state; [0031] FIG. 2 is a sectioned view, taken on the centre transverse plane II-II, of a detail of FIG. 1 ; [0032] FIG. 3 is a view analogous to FIG. 1 , the endoprosthesis being in its expanded state; [0033] FIG. 4 is a view analogous to FIG. 2 of the endoprosthesis of FIG. 3 ; [0034] FIG. 5 is a three-quarter perspective view, from the front, of the endoprosthesis of the device of FIG. 1 in its expanded state; [0035] FIG. 6 is a view analogous to FIG. 2 of a detail of a second treatment device according to the invention; [0036] FIG. 7 is a view analogous to FIG. 6 of a third device according to the invention; [0037] FIG. 8 is a view analogous to FIG. 6 of a fourth device according to the invention, the endoprosthesis not being shown; and [0038] FIG. 9 is a view analogous to FIG. 5 of the endoprosthesis of the device of FIG. 8 . DESCRIPTION OF PREFERRED EMBODIMENTS [0039] The treatment device shown in FIGS. 1 to 5 comprises a tubular endoprosthesis 11 which has an axis X-X′ and which is mounted coaxially on a single support 13 and is connected to that support 13 by releasable retention means. [0040] The endoprosthesis 11 comprises a tubular trellis of stainless steel which has spring-like properties. Thus, this endoprosthesis expands automatically. [0041] The endoprosthesis 11 is, for example, produced by braiding a single thread of a super-resilient material, as described in European Patent Application EP-A-O 857 471 . [0042] The trellis of the endoprosthesis 11 defines, in the vicinity of a distal end 15 of the endoprosthesis 11 , a distal guide passage 16 A for the retention means, and, in the vicinity of a proximal end 17 of the endoprosthesis 11 , a proximal guide passage 17 A for the retention means. [0043] As illustrated by FIG. 5 , each guide passage 16 A, 17 A is delimited by a mesh of the endoprosthesis trellis. The passages 16 A, 17 A are located on the same longitudinal generatrix of the endoprosthesis 11 . [0044] The trellis has, at the ends 15 , 17 of the endoprosthesis 11 , folded threads forming bends. [0045] The endoprosthesis 11 delimits internally a blood circulation canal 18 having an axis X-X′. [0046] In a variant, the passages 16 A, 17 A are delimited by annuli which are fixedly joined to the trellis and which are located in the canal 18 . [0047] As known per se, the endoprosthesis 11 is capable of changing shape spontaneously from a retracted state in which it has a small diameter ( FIG. 1 ) into an expanded state in which it has a larger diameter ( FIG. 5 ), this expanded state constituting its resting state. [0048] In the example illustrated in FIGS. 1 and 2 , the support 13 comprises a hollow flexible metal tube having an axis X-X′. The inside diameter of the tube is suitable for enabling the tube to be threaded onto a filamentary surgical guide (not shown) installed in the patient, before the endoprosthesis 11 is put in place in a blood circulation canal of this patient. [0049] The support 13 extends longitudinally in a single piece between a distal end 19 which is to be implanted in the blood circulation canal and a proximal end 21 which is to be accessible to a surgeon. The proximal end 21 is located at a distance from the endoprosthesis 11 . [0050] Distal and proximal retention openings 23 A and 23 B, which are offset longitudinally, are provided laterally in the support 13 , in the vicinity of the distal end 19 of the support 13 . [0051] In this example, the openings 23 A and 23 B are provided on the same side relative to a centre longitudinal plane of the support 13 . The distance separating the distal retention opening 23 A from the proximal retention opening 23 B is substantially equal to the length of the endoprosthesis 11 in its retracted state, viewed in a longitudinal direction. [0052] At its proximal end 21 , the support 13 delimits a control passage 25 which is closed selectively by means 27 for locking the retention means in position. [0053] The retention means of the endoprosthesis 11 comprise a distal retention rod 31 A and a proximal retention rod 31 B which are associated with a distal retention thread 33 A and a proximal retention thread 33 B, respectively. [0054] The distal retention rod 31 A and the proximal retention rod 31 B have similar structures. Likewise, the distal retention thread 33 A and the proximal retention thread 33 B have similar structures. Consequently, only the distal retention thread 33 A and the distal retention rod 31 A will be described hereinafter. [0055] The retention rod 31 A is located in the support 13 . The length of the rod 31 A is greater than or equal to the distance between the distal retention opening 23 A and the proximal end 21 of the support 13 . [0056] As illustrated in FIG. 2 , the rod 31 A comprises an end hook 35 , an actuating portion 37 , and a control section 39 which projects through the control passage 25 at the proximal end 21 of the support 13 . The retention rod 31 A thus has the general shape of a crook. [0057] The end hook 35 is located at the distal end of the actuating portion 37 . It projects laterally relative to the actuating portion 37 towards the distal retention opening 23 A. [0058] The actuating portion 37 is produced on the basis of a flexible metal rod. It extends in the support 13 . [0059] The control section 39 extends the actuating portion 37 outside the support 13 , through the control passage 25 . [0060] The rod 31 A is movable in translation along the axis X-X′ of the support 13 , between a distal position shown in FIG. 4 for releasing the retention thread 33 A and a proximal position shown in FIG. 2 for traction on the retention thread 33 A. [0061] In the distal release position, the hook 35 extends substantially opposite the distal retention opening 23 A. In that position, the control section 39 has a minimum length. [0062] In the proximal traction position, the hook 35 is located between the proximal retention opening 23 B and the distal retention opening 23 A. The length of the control section 39 is therefore at a maximum. [0063] In the example shown in FIGS. 1 to 5 , the distal retention thread 33 A comprises a single strand of pliable material closed on itself. The distal retention thread 33 A thus forms a clamping ring 43 located outside the support 13 in order to surround the endoprosthesis 11 , and a loop 45 engaged in the support 13 through the distal retention opening 23 A. [0064] The distal retention thread 33 A is mounted permanently on the endoprosthesis 11 . [0065] The clamping ring 43 surrounds the endoprosthesis 11 outside the trellis, in accordance with a circumference around the axis X-X′. It extends between a first end and a second end which are engaged in the proximal guide passage 16 A and which are connected to the loop 45 . [0066] In a variant, the clamping ring 43 is engaged in the trellis of the endoprosthesis 11 , in accordance with a circumference, by passing in succession to the inside and to the outside of the trellis. [0067] The loop 45 extends in the support 13 by connecting the two ends of the clamping ring 43 through the retention opening 23 A. The loop 45 is engaged in the hook 35 of the retention rod 31 A. [0068] The clamping ring 43 is extensible between a configuration for maintaining the endoprosthesis 11 in its retracted state and a configuration for deploying the endoprosthesis 11 . [0069] In the configuration for maintaining shown in FIG. 2 , the diameter of the clamping ring 43 is at a minimum, while the length of the loop 45 in the support 13 is at a maximum. [0070] Conversely, as shown in FIG. 4 , when the clamping ring 43 occupies its deployment configuration, its diameter is at a maximum, while the length of the loop 45 in the support 13 is at a minimum. [0071] When the clamping ring 43 occupies its configuration for maintaining the endoprosthesis 11 , the endoprosthesis 11 is maintained in its retracted state against the support 13 , along a peripheral lateral surface of the support 13 . Conversely, when the clamping ring 43 occupies its deployment configuration, the endoprosthesis 11 is free to occupy its expanded state. [0072] The operation of the first treatment device according to the invention will now be described by way of example. [0073] In a first stage, the device is preserved in a sterile pack (not shown). [0074] In the pack, each retention rod 31 substantially occupies its position for releasing the loop 45 , in which position the hook 35 is located opposite a retention opening 23 A, 23 B. [0075] For each thread 33 A, 33 B, the loop 45 remains engaged in an associated hook 35 , so that the retention rod 31 A, 31 B retains the retention thread 33 A, 33 B. [0076] The distal and proximal retention threads 33 A and 33 B are engaged around the trellis of the endoprosthesis 11 , so that each clamping ring 43 occupies its deployment configuration. The endoprosthesis 11 is thus maintained in its expanded state. [0077] In this condition, the mechanical properties of the endoprosthesis 11 are preserved and, in particular, the tubular trellis thereof is embedded in an extensible and leak-tight film, such as an elastomer. [0078] In a second stage, the surgeon implants a surgical guide (not shown) which moves in the blood circulation canal or the vein from the external point of introduction as far as the region of the vein or the artery into which the tubular endoprosthesis 11 is to be implanted. [0079] The surgeon then removes the device from its pack with a view to implanting the endoprosthesis 11 in the blood circulation canal or the vein. The surgeon subsequently releases the means 27 for locking the rods 31 A, 31 B and pulls on the control sections 39 of the retention rods 31 A, 31 B in order to increase the length of those sections 39 . [0080] During this displacement, each hook 35 is displaced towards the proximal end 21 of the support 13 until the retention rods 31 A, 31 B occupy their position for retaining the loop. [0081] During this displacement, each retention rod 31 A, 31 B pulls on a corresponding retention thread 33 A, 33 B. The length of each loop 45 increases and the diameter of the clamping rings 43 decreases in a corresponding manner. The endoprosthesis 11 thus passes from its expanded state to its retracted state against a peripheral lateral surface of the support 13 , in which state the trellis is substantially resting against the support 13 , around that support 13 . The support 13 is then positioned in the circulation canal 18 . [0082] The surgeon then activates the means 27 for locking the retention rods 31 A, 31 B in position in order to immobilize the rods 31 A, 31 B relative to the support 13 . [0083] The endoprosthesis 11 is thus introduced coaxially with the support 13 as far as its place of implantation by displacement along the surgical guide (not shown). [0084] In some cases, and in order to maintain a minimum radial space requirement, a sheath (not shown) is arranged around the endoprosthesis 11 , before this introduction, and is withdrawn once the introduction has been carried out. [0085] Once the endoprosthesis 11 has been introduced, the surgeon proceeds with the deployment thereof. [0086] Depending on the conformation of the blood circulation canal to be treated, he may choose to deploy first the one or the other of the ends 15 and 17 of the endoprosthesis 11 . [0087] The deployment of the distal end 15 will be described by way of example. [0088] First of all, the surgeon releases selectively the control section 39 of the distal retention rod 31 A. Then he progressively reduces the length of that section 39 by displacing the rod 31 A towards the distal end 19 of the support 13 , which displaces the hook 35 towards the distal end 19 . [0089] During this displacement, the length of the loop 45 decreases. The diameter of the clamping ring 43 increases in a corresponding manner, which enables the endoprosthesis 11 to be deployed radially relative to the axis X-X′ of the support 13 at the distal end 15 of the endoprosthesis 11 . The trellis therefore moves away from the support 13 and approaches the walls P of the canal to be treated in order to rest on those walls P. [0090] If the surgeon is not satisfied with the positioning of the distal end 15 of the endoprosthesis 11 when the latter is deployed, he again actuates the control section 39 by displacing the retention rod 31 A towards the proximal end 21 of the support 13 . This increases the length of the loop 45 and reduces the active length of the clamping ring 43 in order to compress the endoprosthesis 11 against the support 13 . The endoprosthesis 11 is then displaced until it reaches a more satisfactory position. [0091] In an analogous manner, the surgeon then carries out the deployment of the proximal end 17 of the endoprosthesis 11 by means of the proximal retention thread 33 B. [0092] In this configuration, the retention rods 31 A, 31 B occupy their position for releasing the loop 45 . The loops 45 , however, remain engaged in the hooks 35 . [0093] When the surgeon is satisfied with the positioning of the distal end 15 of the endoprosthesis 11 , he displaces the distal retention rod 31 A towards the distal end 19 of the support 13 in order to bring the hook 35 beyond the distal retention opening 23 A until the loop 45 is completely released from the hook 35 . [0094] The distal end 15 of the endoprosthesis 11 is then secured irreversibly to the walls P of the blood circulation canal. [0095] The surgeon then proceeds in the same manner with the proximal end 17 of the endoprosthesis 11 . He subsequently removes the support 13 and the retention rods 31 A, 31 B from the patient. The support 13 is then completely released from the endoprosthesis 11 . [0096] In this device, the length of the retention threads 31 A, 31 B is at a minimum, so that their movement in the support 13 presents a low risk of blocking. [0097] Consequently, the reliability of the deployment of the endoprosthesis is improved since it is no longer necessary to cause long lengths of thread to move in the support 13 . [0098] In a variant shown with a dotted line in FIG. 5 , each loop 45 has an end annulus 101 , which is produced, for example, from a radio-opaque material and which is to be gripped by a hook 35 . [0099] In the second device according to the invention, which is shown in FIG. 6 , the hook 35 of each retention rod 31 A, 31 B is not located at the distal end of the rod 31 A, 31 B. [0100] Thus, each hook 35 delimits on the rod 31 A, 31 B a proximal section 61 and a distal section 63 of non-zero length, which is suitable for retaining the hook 35 in the support 13 . [0101] The hook 35 projects radially relative to the proximal section 61 and to the distal section 63 . [0102] When the retention rod 31 A, 31 B is placed in its position for releasing the loop 45 , with the hook 35 located opposite a retention opening 23 A, 23 B, the distal section 63 rests against the internal surface 67 of the support 13 , distally relative to the opening 23 A, 23 B. This prevents the hook 35 from being carried along by the loop 45 out of the support 13 through the retention opening 23 A, 23 B during the deployment of the endoprosthesis 11 . The reliability of the device is further improved. [0103] In a variant (not shown), the two retention rods 31 A, 31 B are connected mechanically at a point located proximally relative to the proximal retention opening 23 B when the hooks 35 are located opposite the retention openings 23 A, 23 B. [0104] The third device according to the invention, which is shown in FIG. 7 , comprises a single retention rod 31 which is provided with a distal retention hook 35 A located at the distal end of the rod 31 , and with a proximal retention hook 35 B which projects relative to the rod 31 . [0105] The distance separating the distal hook 35 A from the proximal hook 35 B is substantially equal to the distance separating the distal retention opening 23 A from the proximal retention opening 23 B. [0106] This third device permits the simultaneous deployment of the proximal end 17 and the distal end 15 of the endoprosthesis 11 . [0107] A fourth device according to the invention is shown in FIGS. 8 and 9 . This device constitutes a variant of the second treatment device according to the invention. However, unlike the second device, each retention thread 33 A, 33 B is releasable from the endoprosthesis 11 . [0108] To that end, each retention thread 33 A, 33 B forms a principal loop 45 connected to a first end of the clamping ring 43 , and an auxiliary loop 201 located in the support 13 and connected to a second end of the clamping ring 43 . [0109] The clamping ring 43 is formed by two adjacent strands of the retention thread 33 A, 33 B. These two strands are folded into a loop at the first end of the clamping ring 43 in order to form the principal loop 45 and are folded into a loop at the second end of the clamping ring 43 in order to form the auxiliary loop 201 . [0110] The principal loop 45 and the auxiliary loop 201 are connected to the clamping ring 43 through the same retention opening 23 A, 23 B and through the same guide passage 16 A, 17 A. [0111] Unlike the device shown in FIG. 6 , each retention rod 31 A, 31 B has at its distal end a clip 203 for retaining the auxiliary loop 201 . [0112] The clip 203 is formed by a fold 205 in the distal section 63 of the retention rod 31 A, 31 B extending between the distal end of the rod 31 A, 31 B as far as a point located proximally relative to the retention hook 35 . The fold 205 extends in the opposite direction to the hook 35 and the retention opening 23 A, 23 B, relative to the axis of the rod 31 A, 31 B. The clip 203 opens towards the proximal end 21 of the support 13 . [0113] The auxiliary loop 201 is engaged in the retention clip 203 . [0114] When the surgeon removes the fourth device from its pack and displaces each retention rod 31 A, 31 B towards the proximal end 21 of the support 13 , the hook 35 and the clip 203 of each rod 31 A, 31 B also move towards that proximal end. [0115] During this displacement, the loop 45 and the auxiliary loop 201 are pulled in the support 13 towards the proximal end 21 , so that the length of the clamping ring 43 decreases in order to cause the endoprothesis 11 to pass from its expanded state into its retracted state against the support 13 . [0116] The deployment of the endoprosthesis 11 is then analogous to that of the second treatment device. [0117] When the endoprosthesis 11 is deployed in position in the blood circulation canal and the surgeon is satisfied with the positioning of this endoprosthesis, he displaces the retention rod 31 A, 31 B towards the distal end 19 of the support 13 in order to bring the hook 35 beyond the corresponding retention opening 23 A, 23 B. The principal loop 45 is then completely released from the hook 35 . [0118] However, bearing in mind the length of the fold 205 , the auxiliary loop 201 remains engaged in the clip 203 . [0119] Subsequently, when the surgeon pulls the retention rod 31 A, 31 B towards the proximal end 21 of the support 13 , he also pulls on the corresponding retention thread 33 A, 33 B by way of the auxiliary loop 201 engaged in the clip 203 in order to permit the joint displacement of the retention thread 33 A, 33 B and the retention rod 31 A, 31 B. The retention thread 33 A, 33 B is then completely released from the endoprosthesis 11 and is removed from the patient at the same time as the retention rod 31 A, 31 B.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention pertains to the art of dishwashers and, more particularly, to a dishwasher having a controller that selectively releases a rinse aid during a rinse cycle based on a temperature of washing fluid in the dishwasher. [0003] 2. Discussion of the Prior Art [0004] The prior art is replete with dishwashers that employ various techniques to wash a wide range of kitchenware, such as dishes, pots, pans, glasses and the like. The dishwashers perform washing operations that typically employ a number of cycles to wash the kitchenware. In general, the number and type of cycles vary from manufacturer to manufacturer. In addition to standard cycles, e.g., wash, rinse and dry, often times, a dishwasher will have “special” cycles that address particular wash conditions, e.g., heavy soil, light soil, pot scrubber etc. In any event, the cycles are generally divided into steps, each having a particular duration. However, while the number and duration of steps will vary from appliance to appliance, there are certain steps that occur in every washing operation. That is, every washing operation has at least one washing step, during which water is mixed with detergent and directed onto kitchenware to wash away soil, and at least one rinsing step, during which clean water is sprayed onto the kitchenware to remove remaining soil and/or detergent. [0005] As indicated above, during the washing step, detergent is mixed with water to form a washing fluid. The detergent can simply be placed within the dishwasher and exposed to sprays or jets of water or, alternatively, released from a dispenser. The release of detergent is typically based upon time. That is, at some point after initiation of the washing step, a controller executes a timed release of detergent from the dispenser. [0006] During the rinsing step, clean water is sprayed onto the kitchenware to wash away any remaining soil and/or washing fluid. Actually, depending on the particular dishwasher, the washing operation may include multiple rinse steps to ensure that all the soil and/or washing fluid is washed away, leaving behind sparkling clean dishes. Following the rinse step, the washing operation enters a drying phase or step where the dishes are allowed to dry, either by the passage of time, or through the introduction of heat into the dishwasher. Unfortunately, after the drying phase, water spots often times remain on the kitchenware. While particularly noticeable on glassware, the water spots can also be present on other kitchenware, such as plates, silverware and the like. [0007] In order to reduce water spots, many consumers add a rinse aid that is released during one of the rinse steps. In some cases, the rinse aid can be in the form of a tablet that is supported from a dishrack in the dishwasher. However, in most cases, the rinse aid is in the form of a liquid released from a dispenser. That is, at some point during the rinse step, a controller will automatically release the rinse aid from the dispenser. More specifically, as long as there is rinse aid in the dispenser, the controller will release the rinse aid into the washing chamber at a predetermined time during the rinse step. The rinse aid then mixes with the water and is sprayed into the kitchenware in order to reduce spotting. However, adding rinse aid at an inappropriate point can result in improper mixing of the water and rinse aid. [0008] Based on the above, there exists a need in the art for a dishwasher including a controller that releases rinse aid only at an appropriate point of a rinse cycle. More specifically, there exists a need in the art for a dishwasher that can sense a temperature of washing fluid and release rinse aid at a point in the rinse cycle at which proper mixing of rinse aid and washing fluid will occur. SUMMARY OF THE INVENTION [0009] The present invention is directed to a dishwasher having a system for conditionally releasing a rinse aid into a washing chamber. In accordance with the invention, the dishwasher includes a dispenser for storing rinse aid, a sensor for detecting a temperature of water or washing fluid in the washing chamber and a controller operatively coupled to the sensor and the dispenser. The controller, based upon a signal received from the sensor indicating a temperature of the washing fluid, activates the dispenser to release the rinse aid. The controller is programmed to only release the rinse aid when the temperature of the washing fluid is above a predetermined threshold value. That is, the controller will only release the rinse aid if the temperature of the washing fluid is above a cloud point of the rinse aid such that foaming will not occur upon mixing of the rinse aid with the washing fluid. [0010] Additional objects, features and advantages of the present invention will become more readily apparent from the following detailed description of a preferred embodiment when taken in conjunction with the drawings wherein like reference numerals refer to corresponding parts in the several views. BRIEF DESCRIPTION OF THE DRAWING [0011] FIG. 1 is an upper right, perspective view of a dishwasher incorporating a rinse aid dispensing system constructed in accordance with the present invention, with a door of the dishwasher being in an open position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0012] With reference to FIG. 1 , a dishwasher constructed in accordance with the present invention is generally indicated at 2 . As shown, dishwasher 2 includes a tub 5 which is preferably injection molded of plastic or formed from stainless steel so as to include integral bottom, side, rear and top walls 8 - 12 respectively. Within the confines of walls 8 - 12 , tub 5 defines a washing chamber 14 within which soiled kitchenware is adapted to be placed upon shiftable upper and lower racks (not shown). Tub 5 has attached thereto a frontal frame 16 which pivotally supports a door 20 used to seal washing chamber 14 during a washing operation. As shown, door 20 is pivotally supported to frame 16 at a bottom portion 21 . In connection with the washing operation, door 20 is preferably provided with a detergent tray assembly 22 including a detergent dispenser 23 within which a consumer can place liquid, particulate or tabular washing detergent for dispensing at a predetermined portion of a washing operation. In addition, in a manner that will be discussed more fully below, detergent tray assembly 22 also includes a rinse aid dispenser 24 for releasing a rinse aid during another predetermined portion of the washing operation. In any case, door 20 is provided with a liner 25 within which is arranged detergent tray assembly 22 , as well as a vent 26 that allows hot air to escape from washing chamber 14 following a drying operation. Liner 25 also includes a lower lip portion 27 that extends across bottom portion 21 of door 20 . [0013] Disposed within tub 5 and, more specifically, mounted within a central opening (not shown) in a sump portion 28 of tub 5 is a pump assembly 30 . In the embodiment shown, pump assembly 30 includes a main housing 33 , an annular, radially outermost strainer 36 and a filter guard 39 . Extending about a substantial portion of pump assembly 30 , at a portion raised above bottom wall 8 , is a heating element 44 . In a manner known in the art, heating element 44 preferably takes the form of a sheathed, electric resistance-type heating element. A detailed description of the exact structure and operation of pump assembly 30 does not form part of the present invention and thus will not be described more fully herein. Instead, various known pump arrangements can be employed, such as that disclosed in U.S. Pat. No. 6,997,193 which is incorporated herein by reference. [0014] In general, pump assembly 30 is adapted to direct washing fluid to at least a lower wash arm 47 and a conduit 51 . As depicted, conduit 51 includes a substantially horizontal lower section 53 extending away from main housing 33 of pump assembly 30 , a vertical section 54 , which generally extends along rear wall 11 , and a generally horizontally extending upper portion (not shown) which leads to an upper wash arm (also not shown). Vertical section 54 has attached thereto a wash fluid diverter (not shown) that engages with a rack mounted wash arm (also not shown). In any case, pump assembly 30 is designed to establish a controlled flow of washing fluid that is sprayed upon kitchenware supported within washing chamber 14 during the washing operation. [0015] At the completion of the washing operation, pump assembly 30 guides the washing fluid through a drain pump (not shown) having associated therewith a drain hose 85 including at least one corrugated or otherwise curved portion 89 that extends about an arcuate hanger 92 provided on an outside surface of side wall 10 . Drain hose 85 is also preferably secured to tub 5 through various clips, such as that indicated at 95 . In any event, in this manner, an upper loop is maintained in drain hose 85 to ensure proper drainage in a manner known in the art. [0016] In accordance with the invention, dishwasher 2 includes a controller 100 that is operatively connected to rinse aid dispenser 24 . Controller 100 is also operatively connected to a temperature sensor 104 which is preferably mounted within sump portion 28 of washing chamber 14 . Temperature sensor 104 is positioned so as to detect and signal a temperature of washing fluid circulating within washing chamber 14 . In accordance with the invention, controller 100 will only activate rinse aid dispenser 24 , releasing rinse aid into washing chamber 14 , when a temperature of the washing fluid is at or above a predetermined temperature value. Most preferably, controller 100 will only activate rinse aid dispenser 24 when the temperature of the washing fluid, as sensed by temperature sensor 104 , is above approximately 125° F. (51.7° C.). That is, rinse aid will only be released when the temperature of the washing fluid is above a cloud point of the rinse aid as will be discussed more fully below. [0017] After loading kitchenware into washing chamber 14 , detergent into detergent dispenser 23 and rinse aid into rinse aid dispenser 24 , a consumer initiates a washing operation in a manner known in the art through user interface 110 . Initially, water is introduced into tub 5 upon opening of a water valve 115 , with the water being sprayed about washing chamber 14 by, for example, wash arm 47 to perform an initial dishware cleansing operation. After a predetermined time period, dishwasher 2 enters a washing step at which point detergent dispenser 23 is opened, releasing detergent into washing chamber 14 to mix with the water to form a washing fluid. In some instances, the water is heated by heating element 44 prior to the introduction of detergent. In any event, the washing fluid enters pump assembly 30 and is sprayed about washing chamber 14 onto the kitchenware. Often times, periodic partial drain steps are initiated to remove soil accumulating in the washing fluid. That is, depending upon a level of soil in the washing fluid, as sensed by, for example, a turbidity sensor (not shown), some portion of the washing fluid is directed through drain hose 85 and onward to a household drain and additional fresh water is introduced into washing chamber 14 . [0018] At the completion of the washing step, all of the washing fluid is drained from washing chamber 14 and a rinse step is initiated during which water which forms a fresh washing or rinse fluid is released into washing chamber 14 . Once a sufficient amount of rinse fluid is in washing chamber 14 , pump assembly 30 is activated and the rinse fluid is sprayed through, for example, wash arm 47 , onto the kitchenware. As the rinse fluid circulates throughout the system, heating element 44 is activated to raise the temperature of the rinse fluid. In accordance with the invention, at a predetermined point in the cycle, controller 100 checks to make sure the water temperature exceeds a predetermined threshold temperature, e.g., approximately 125° F. (51.7° C.) as determined by sensor 104 . If not, rinse aid is not dispensed. That is, controller 100 will only release rinse aid when the temperature of the rinse fluid is sufficiently above the cloud point of the rinse aid. More specifically, if, for whatever reason, the temperature of the rinse fluid does not reach the predetermined temperature, controller 100 will not release rinse aid, even though dispenser 24 is full. In this manner, controller 100 ensures that rinse aid dispenser 24 is not activated to release a rinse aid if the temperature of the washing fluid is below the predetermined temperature. Accordingly, upon releasing the rinse aid into the washing fluid, controller 100 ensures that the rinse aid will not foam which could create excessive noise or create cavitations that could be detrimental to pump assembly 30 . [0019] At this point, it should be readily understood that the present invention ensures that rinse aid is only dispensed when the temperature of the washing fluid is of a sufficient level such that the rinse aid properly mixes with the washing fluid to ensure adequate dispersion within the wash system and eliminate any negative effects that could be associated with foaming of the rinse aid upon mixing with a washing fluid having too low of a temperature. In this manner, the present invention aids in having dishwasher 2 operate quietly and, ultimately, prolongs an overall service life of pump assembly 30 . [0020] Although described with reference to a preferred embodiment of the invention, it should be readily understood that various changes and/or modifications can be made to the invention without departing from the spirit thereof. For instance, while shown in connection with a conventional dishwasher, the present invention could be readily incorporated into other dishwashers such as, for example, drawer-type dishwashers. Also, the particular type and style of the rinse aid dispenser employed in connection with the present invention can readily vary. In general, the invention is only intended to be limited by the scope of the following claims.

1a

This application is a continuation of U.S. patent application Ser. No. 11/355,336, filed Feb. 16, 2006, which is a continuation of U.S. patent application Ser. No. 10/865,428, filed Jun. 10, 2004, which is a continuation of U.S. patent application Ser. No. 10/333,957, filed Jan. 27, 2003, which claims the benefit under 35 U.S.C. §371 of PCT/US01/23420, filed Jul. 26, 2001, which claims priority under 35 U.S.C. §1.119(e) of Provisional Application Ser. No. 60/221,672, filed Jul. 26, 2000, the disclosures of which are incorporated by reference in their entireties herein. BACKGROUND OF THE INVENTION The invention relates to the use of non-sedating barbiturate compounds given in a manner and dosage effective to produce blood levels and brain levels of these drugs and/or their active metabolites sufficient to provide a neuroprotectant effect. In particular, the methods and formulations of the invention permit treatment of cerebral ischemia, head trauma and other acute neurologic injuries, and prevention of resulting neuronal damage. Ischemia (stroke) is the third leading cause of death in the United States. When blood supply to the brain is reduced below a critical threshold, a cascade of biochemical events leads to irreversible damage to neurons and brain infarction. Research on treatment and prevention of ischemia is extensive but unfortunately it remains at a basic stage and no adequate therapies are yet in practice (10). Barbiturates in high concentrations have been shown to be neuroprotective in cerebral ischemia in rodents and primates, to reduce the extent of ischemia brain infarction, and to prevent or lessen brain damage (1-4). One theory as to how barbiturates prevent neuronal injury in ischemia is that they inhibit the ischemia-induced uncontrolled release of neurotransmitters, which can attain high, neurotoxic concentrations that cause neuronal death (5). The literature regarding the neuroprotective effects of anesthetic barbiturates is over two decades old, but the clinical use of barbiturates has been severely limited because of toxicity. The dosages and blood and brain levels necessary to confer neuroprotection are toxic and cause lethargy, stupor, and coma. Even higher doses that might be more effective are lethal (1-4, 6), making barbiturates unsuitable for treatment of ischemia (1). These toxic side effects establish a “functional ceiling” on dosage for barbiturates, and have discouraged further research into the use of anesthetic/sedative barbiturates to protect from ischemia. Levitt et al., U.S. Pat. No. 4,628,056 describes non-sedating oxopyrimidine derivatives and their use as anticonvulsants, anti-anxiety and muscle relaxant agents. The literature does not suggest the use of such compounds as neuroprotectant agents. Indeed, even in published studies about using sedative barbiturates for neuroprotection there is no reference to non-sedating barbiturate compounds. It is generally believed that the anticonvulsant and neuroprotective effects of barbiturates are linked to their sedative/hypnotic effects. For example, Lightfoote et al. suggested that the protective effects of pentobarbital are due to the duration of the barbiturate-induced anesthesia (3). This viewpoint has been reinforced by biochemical studies at the cell receptor level that relate all these effects to action at the GABA receptor. Thus, the prior art teaches away from using sedative barbiturates for neuroprotection because of their toxicity, and also teaches away from using non-sedative barbiturates as neuroprotectants because they lack sedating or anesthetic properties. SUMMARY OF THE INVENTION In summary, the invention involves non-sedating barbiturates such as for example 1,3-dimethoxymethyl 5,5-diphenyl-barbituric acid (DMMDPB), 1-monomethoxymethyl 5,5-diphenylbarbituric acid (MMMDPB) and diphenyl-barbituric acid (DPB) and their precursors, derivatives and analogs, and their administration over a range of dosages that result in a range of blood levels and brain levels of these drugs and their metabolites making them useful as neuroprotectants. In particular, the invention is directed to the treatment of cerebral ischemia, head trauma and other acute neurologic injuries, using non-sedating barbiturates. There are many circumstances where individuals at risk of cerebral ischemia are clearly identified in advance, for example: individuals undergoing cardiac surgery or carotid endarterectomy, and individuals with atrial fibrillation, transient ischemic attacks (TIAs), bacterial endocarditis, strokes, or subarachnoid hemorrhage due to a cerebral aneurysm. In such cases, a non-sedating barbiturate is used prophylactically in individuals at risk for ischemic damage. The drugs can also be used after an acute event. These compounds can be given in oral form as a tablet, capsule, liquid or via intravenous or other parental routes. This invention succeeds where previous efforts to treat cerebral ischemic attack with barbiturates have failed. This invention solves a problem previously thought to be insoluble, that of toxic effects of neuroprotective dosages of barbiturates. The invention avoids the toxicity and sedative effects of barbiturates known in the prior art without loss of efficiency. This invention satisfies a long-felt need for a non-toxic neuroprotectant, and is contrary to the teachings of the prior art regarding the inability of barbiturates to produce clinically meaningful neuroprotection. According to the invention, it is possible to separate the anticonvulsant and sedative effects of barbiturates, and neuroprotection correlates much better with the anticonvulsant rather than the sedative effect of barbiturates. This invention differs from the prior art in the recognition of specific compounds, their modifications and dosages that are effective in neuroprotection but that were not previously recognized. The present invention is a method for providing neuroprotection to a mammal, preferably a human. The method comprises administering to the mammal a non-sedating barbiturate in a dose effective to provide a neuroprotection effect. Non-sedating barbiturates for use in the invention include one or more selected from the group consisting of 1,3-dimethoxymethyl 5,5-diphenyl-barbituric acid (DMMDPB), 1-monomethoxymethyl 5,5-diphenylbarbituric acid (MMMDPB), and diphenyl barbituric acid (DPB). The precursors, derivatives and analogs of the foregoing compounds, as well as the salts of all the foregoing are also suitable for practicing the invention. The effective neuroprotective dose of the non-sedative barbiturate preferably exceeds the coma-producing dose of a sedative barbiturate. Depending on the specific need of the mammal, the dose of the non-sedative barbiturate may exceed a dose that would be lethal with a sedative barbiturate. This unexpected and seemingly paradoxical effect of the present method is further reflected in the relative dosage levels that are possible with the methods of this invention. Also, the neuroprotective dose of the non-sedative barbiturate exceeds the minimum anticonvulsant dosage of the barbiturate. In some embodiments of the present invention the effective dose of the non-sedative barbiturate is in the range of from about 2 times to about 5 times the anticonvulsant dosage. In yet other contexts where the need of the mammal requires, the effective dose of the non-sedative barbiturate is in the range of from about 5 times to about 10 times the anticonvulsant dosage of the non-sedative, or even higher so long as the dose is clinically acceptable. Advantageously, the neuroprotective effect of the present methods can be used to mitigate the effect of cerebral ischemic. The non-sedating barbiturate can be administered orally, intravenously, transdermally, in combination with an adjuvant, or transpulmonarily by means of a particulate or aerosol inhalant. Moreover, within the scope of the invention, the non-sedating barbiturate can be administered preventively, prophylactically or therapeutically, at a clinically acceptable dose. The compound may be administered prophylactically before evident neuronal damage, or therapeutically after onset of neuronal damage. The neuroprotective effect diminishes, or protects the subject from, neuronal damage caused by head trauma or cerebral ischemia. The compound may be administered in conjunction with cardiac surgery or carotid endarterectomy. The mammalian subject may have or be at risk for atrial fibrillation, a transient ischemic attack (TIA), bacterial endocarditis, a stroke, head trauma, or subarachnoid hemorrhage. Typically, to achieve neuroprotection the non-sedating barbiturate is administered in a dose sufficient to obtain blood concentrations of at least about 30 μg/ml of barbiturate, preferably at least about 100 μg/ml, more preferably at least about 250 μg/ml, and possibly as high as 200-300 μg/ml, or even higher. In contrast, the reported therapeutic range for phenobarbital is lower, 10-30 μg/ml blood levels (6). Thus, preferred ranges are at or above about 25, 30, 50, 75, 100, 200, 250, or 300 μg/ml. The invention includes a pharmaceutical composition comprising a non-sedating barbiturate administered in an amount effective to have a neuroprotectant effect. Preferably, the non-sedating barbiturate is administered in oral doses in the range of from about 25 to about 1,500 mg/kg/day body weight. Preferably the dose is greater than about 25 mg/kg/day, or greater than about 100 mg/kg/day, or greater than 250 mg/kg/day. A preferred dose is one that is pharmacologically equivalent to a dose of about 1000 mg/kg/day in the rat. Thus, dosage forms may be sufficient individually or in multiple doses to provide a dose equal to or above about 15, 20, 25, 50, 70, 100, 250, 500, 1000, or 1500 mg/kg body weight per day. In human trials it has been unexpectedly found that DMMDPB, one of the neuroprotectant compounds, is much better absorbed in humans than in rats or dogs. It has further been found that the half life of DMMDPB, as well as the half life of MMMDPB and DPB are greater than the half-lives found in rats or dogs. Specifically, with dosages of 20 mg/kg/day, the half-lives of DMMDPB, MMMDPB, and DPB are approximately 20 hrs, 20 hrs, and 50 hrs respectively after a two week exposure in humans. Similarly, the maximum concentration (Cmax) of the drug in the blood following 7 days of dosing in the range of 20 mg/kg/day are 1.2 μg/ml, 36 μg/ml and 43 μg/ml respectively. The unexpectedly high absorption and prolonged half-life in humans makes it possible to achieve substantial blood levels with lower than expected oral dosages. Thus, for example, it is possible to obtain total barbiturate blood levels (i.e., DMMDPB+MMMDPB+DPB)>53 μg/ml with dosages of about 15 mg/kg/day; and total barbiturate levels>72 μg/ml with dosages in the range of 20 mg/kg/day. Blood levels of non-sedating barbiturates greater than 100 μg/ml are achieved with dosages between about 40 and about 100 mg/kg/day, and are within the scope of the invention. With parenteral administration of non-sedating barbiturates, similar blood concentrations are obtained with daily dosages of less than 25 mg/kg/day. However, first day loading dosages may still need initial dosages of greater than 25 mg/kg. The invention provides an article of manufacture comprising a container comprising a pharmaceutical composition and a label with indications for use as a neuroprotectant, the pharmaceutical composition comprising a non-sedating barbiturate compound in an amount effective for neuroprotection upon administration to a subject in need of neuroprotection; and a pharmaceutically acceptable carrier or excipient. Another embodiment is a method for providing neuroprotection comprising (a) diagnosing a patient's need for cerebral neuroprotection, (b) selecting a non-sedative barbiturate, and (c) providing to the patient a dose of the non-sedative barbiturate sufficient to raise the concentration in the patient's brain to a level effective to provide neuroprotection. Further objectives and advantages will become apparent from a consideration of the description and examples. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In describing preferred embodiments of the present invention, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected. It is to be understood that each specific element includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. Each reference cited here is incorporated by reference as if each were individually incorporated by reference. The term “non-sedative barbiturate” encompasses the family of 5,5-diphenyl barbituric acid anticonvulsant compounds described in Levitt et al., U.S. Pat. No. 4,628,056, and metabolic precursors and metabolites, and derivatives and structural analogs (including addition salts thereof) having a non-sedative neuroprotectant activity. Other barbituric acid derivatives that are non-sedating are also within the scope of the invention. Derivatives, precursors, and analogs of barbituric acid include barbituric acids of the formula: wherein one or more nitrogen is substituted with lower alkyl, or a lower alkoxy substituted lower alkyl group; or at least one of R 1 and R 2 , together with the nitrogen, forms a carbamate, an amide, or an acetal of the formamide derivative, i.e. R 1 or R 2 is CO 2 R, COR or CH(OR) 2 . Methylether groups are preferred R 1 and R 2 groups and methoxymethyl is more preferred. Methyl is also a preferred value for R 1 and/or R 2 . Other derivatives of barbituric acids according to the invention are carbamates, amides and acetals where one or both of R 1 and R 2 is CH 2 OR 5 , wherein R 5 is lower alkyl, alkylaryl or benzyl; CO 2 R 6 , wherein R 6 is lower alkyl or aryl; COR 7 , wherein R 7 is hydrogen, lower alkyl or aryl; or CH(OR 8 ) 2 , wherein R 8 is a lower alkyl group. Preferred values for R 3 and R 4 are aryl, phenyl, phenyl substituted with a halogen or lower alkyl group, benzyl, benzyl wherein the aromatic ring is substituted with a halogen or lower alkyl group, lower alkyl or lower alkyl substituted with an aromatic moiety. Aryl represents any carbocyclic ring, such as phenyl, naphthyl and higher analogues, as well as heteroaromatic rings substituted with one or more heteroatoms such as sulfur, oxygen and nitrogen. According to the invention, nonsedating barbituric acid derivatives are those where at least one of R 3 and R 4 is an aromatic ring or an aromatic ring containing moiety e.g. aryl, phenyl, substituted phenyl, benzyl, substituted benzyl or arylalkyl. Preferred substituents on the aromatic rings are methyl, ethyl, and fluorine. Phenyl and substituted phenyl are preferred for R 3 and R 4 . Embodiments where R 3 and R 4 are both phenyl are most preferred. In preferred compounds, one of R 1 and R 2 is hydrogen, or one or both of R 1 and R 2 is methyl or alkoxymethyl, preferably methoxymethyl. At least one and preferably both of R 3 and R 4 is preferably phenyl or substituted phenyl, tolyl, fluorophenyl, ethylphenyl. As can be readily understood, salts of the above compounds are also contemplated, including organic salts, such as acid addition and base addition salts. In order to fall within the scope of this genus, the compound must (1) be a barbituric acid chemical derivative, (2) not be sedating, in the sense that the subject remains awake and alert at useful doses, that is, not anesthetized, and (3) manifest neuroprotective activity in an animal model described herein or in a human at a dose that is not toxic to the relevant animal species, or show activity in an in vitro assay now known or later discovered that is accepted as a model for in vivo neuroprotection. These barbituric acid derivatives may be both prodrugs and active ingredients in the subject, thus combining to produce the desired pharmacodynamic effect of neuroprotection. Sustained levels are readily obtained with such compounds. Thus, certain barbiturate compounds have been developed and have anticonvulsant activity without being sedating even at very high brain concentrations (that would be lethal with other barbiturates). According to the invention, such compounds are used to neuroprotect an animal at risk for or suffering from one or more ischemic episodes such as that modeled by middle cerebral artery occlusion, while these compounds do not cause the toxic effects of other barbiturates when present at concentrations required for prevention of ischemic brain damage. As described herein, non-sedative barbiturate drugs lessen or prevent ischemic brain damage in a rat model of focal cerebral ischemia produced by middle cerebral artery occlusion. This demonstrates utility in humans. In a reproducible, predictive model of cerebral ischemia known in the art, selective neuronal damage is produced in the striatum and cerebral cortex by bilateral carotid occlusion accompanied by systemic hypotension. The resulting cerebral ischemia causes a release of excitotoxic neurotransmitters and dopamine in striatum. Pentobarbital inhibited this ischemia-induced release, pointing to one possible mechanism of barbiturate neuroprotection. (5) A neuroprotective dose of pentobarbital was found to be 70 mg/kg. Inhibition of neurotransmitter release by several neuroprotective anesthetic agents (isoflurane, etomidate, propofol) was also known. The above and similar animal models (see Examples) can be used (1) to analyze whether a non-sedative barbiturate with anticonvulsant properties but little or no anesthetic activity can provide neuroprotection in the striatum or hippocampus, and (2) to determine if the agent prevents or reduces release of neurotransmitters in response to ischemia. Uncontrolled or unmodulated neurotransmitter release is one of the postulated mechanism of ischemic damage. For non-sedating barbiturates that inhibit release of neurotransmitters, this approach can serve as a biochemical assay for predicting utility of a compound according to the invention, and the invention encompasses such methods. A neuroprotective effect according to the invention can be demonstrated and characterized by performing a dose-response study and measuring statistically significant differences in neuronal damage at the various doses of the drug. Dose-response curves generated in such studies can be used to compare the relative degree of neuroprotection and sedation of a test compound. Cerebral ischemia is induced in rats by occlusion of the middle cerebral artery (“MCA”) (7-9). The occlusion can be performed in an irreversible or reversible manner. In the latter case, after a period of obstruction, blood flow is restored. These animal preparations are thus appropriate to model various types of strokes in humans and to permit determination of a drug's neuroprotective action. Such models permit observation of the prevention of brain damage and the evaluation of the drugs as being useful for humans who are at risk for ischemic stroke for reduction of subsequent brain damage induced by an ischemia event. Because they prevent brain damage in models of irreversible ischemia and reversible ischemia with restoration of blood flow, the compounds of the invention are also useful for treating acute ischemic stroke either alone or in combination with other agents, for example, thrombolysis such as tissue plasminogen activator that reduce the extent of brain infarction when circulation is restored. The term “treatment” is intended to encompass administration of compounds according to the invention prophylactically to prevent or suppress an undesired condition, and therapeutically to eliminate or reduce the extent or symptoms of the condition. Treatment according to the invention is given to a human or other mammal having a disease or condition creating a need of such treatment. Treatment also includes application of the compound to cells or organs in vitro. Treatment may be by systemic or local administration. The non-sedative barbiturate compositions of the present invention, may be formulated into “pharmaceutical compositions” with appropriate pharmaceutically acceptable carriers, excipients or diluents. If appropriate, pharmaceutical compositions may be formulated into preparations including, but not limited to, solid, semi-solid, liquid, or gaseous forms, such as tablets, capsules, powders, granules, ointments, solutions, suppositories, injections, inhalants, and aerosols, in the usual ways for their respective route of administration. Methods known in the art can be used to achieve time-release of the composition or to prevent metabolism, release or absorption of the composition until it has reached its intended target site. A pharmaceutically-acceptable formulation should be employed that does not inactivate the active drug of the present invention. In pharmaceutical dosage forms, the compositions may be used alone or in appropriate association, as well as in combination with, other pharmaceutically-active compounds. The pharmaceutical compositions of the present invention can be delivered via various routes and to various sites in an animal body to achieve the desired neuroprotective effect. Local or systemic delivery can be accomplished by injection, infusion, application or instillation of the composition into one or more body cavities, or by inhalation or insufflation of an aerosol. Parenteral administration can be by intramuscular, intravenous, intraperitoneal, subcutaneous intradermal, or topical administration. The compositions of the present invention can be provided in unit dosage form, wherein each dosage unit, e.g., a teaspoon, tablet, solution, or suppository, contains a predetermined amount of the active drug or prodrug, alone or in appropriate combination with other pharmaceutically-active agents. The term “unit dosage form” refers to physically discrete units suitable as unitary dosages for human and animal subjects, each unit containing a predetermined quantity of the composition of the present invention, alone or in combination with other active agents, calculated in an amount sufficient to produce the desired effect, in association with a pharmaceutically-acceptable diluent, carrier (e.g., liquid carrier such as a saline solution, a buffer solution, or other physiological aqueous solution), or vehicle, where appropriate. The specifications for the novel unit dosage forms of the present invention depend on the particular effect to be achieved and the drug's particular pharmacodynamics in the particular host. An “effective amount” of the composition is that required to produce the desired pharmacologic effect in a host. This can be monitored using any of a number of end-points known to those skilled in the art. The “effective dose” will depend on the bioavailability of specific dosage forms delivered by one or another route of administration. The neuroprotective dosage and blood level of the present compounds is at least 2-fold and preferably at least about 5 to 10-fold the anticonvulsant dosage of a sedating barbiturate. Based on rat data, the anticonvulsant ED 50 for phenobarbitol is about 50-100 mg/kg. A non-sedating barbiturate dose of 1 g/kg given over 7 days protects against cerebral ischemia in the rat. Similar or lower doses are suitable in humans based on the enhanced absorption in humans discussed above. The amount of each active agent employed in the Examples below provides general guidance for the range that can be utilized by the skilled practitioner to optimize the doses and methods of the present invention. Moreover, such dose ranges do not preclude use of a higher or lower dose of a component, as might be warranted in a particular application. For example, the actual dose and schedule may vary depending on whether the compositions are administered in combination with other drugs, or depending on inter-individual differences in pharmacokinetics, drug disposition, and metabolism. Similarly, amounts may vary for in vitro applications. It is within the skill in the art to readily adjust the dose in accordance with the necessities of a particular situation without undue experimentation Having now generally described the invention, the same will be more readily understood through reference to the following examples which are provided by way of illustration, and are not intended to be limiting of the present invention, unless specified. Example 1 General Design The non-sedative barbiturate (NSB) drug is tested in rats exposed to either reversible or irreversible ischemia. Varying doses of drug are administered. The neuroprotective effect is compared to a negative control (placebo) and a positive control, pentobarbital, a known neuroprotective but sedative barbiturate, given at doses known to reduce infarct volume in cerebral ischemia (1-4). Animals are sacrificed several days after the onset of the ischemic insult and the brains examined to determine the volume of brain infarction as an outcome measure of the drug's reduction of ischemic brain damage. The animals are examined clinically and graded prior to sacrifice to determine if the drug has conferred any beneficial effect on relevant functions following ischemic “stroke.” Four experimental models are preferred for testing the neuroprotective effects of the NSB drug. See Ginsberg, M. D., “Animal Models of Global and Focal Cerebral Ischemia,” Chapter 34 in Welsh, K. M. A et al., Primer on Cerebrovascular Diseases, Academic Press, New York, 1997; and Pulsinelli W A, Brierley J B. A new model of bilateral hemispheric ischemia in the unanesthetized rat, Stroke 1979 May-June 10 (3): 267-72. 1. Irreversible ischemia produced by middle cerebral artery (MCA) occlusion; 2. Reversible ischemia produced by MCA occlusion; 3. Transient global ischemia produced by cross-clamping the aorta for a defined interval; and 4. Transient global ischemia produced by cauterizing both vertebral arteries and reversibly clamping the common carotid arteries. In each experimental model, groups of rats are treated with either: 1. Negative control (placebo) via nasogastric (NG) tube; 2. Positive control: intraperitoneal (IP) dose of 70 mg/kg pentobarbital; or 3. The NSB compound DMMDPB (or a compound being tested for its utility in the present invention) via NG tube at doses between 500 mg/kg and 1500 mg/kg for 7 days prior to experimental infarctions. The results are compared. Example 2 Irreversible Cerebral Ischemia Irreversible MCA occlusion was produced by ligating the carotid artery and then inserting a filament into the origin of the MCA with the animal maintained under halothane anesthesia. Blood flow in the MCA was measured by laser doppler and those animals in which a significant drop in blood flow occurred were considered to have experienced cerebral ischemia, and to be at risk for subsequent damage (i.e., a stroke). Indeed, no clinical strokes occurred in animals that did not experience a precipitous drop in MCA blood flow. All the animals showing with a drop in MCA blood flow experienced strokes. Animals at risk were then followed behaviorally and scored by clinical findings using the Bederson grading scale as either: 0 no evidence of stroke 1 mild stroke 2 moderate stroke 3 severe stroke Those animals that survived for three days were sacrificed and their brains examined. Animals to be sacrificed were given chloral hydrate (35 mg/kg IP, and their brains were fixed by intracardiac perfusion with heparinized 0.9% saline followed by 10% buffered formalin. The brains were removed from the cranial vault with care to leave the arachnoid intact with the intracranial vessels underneath. The fixed brains were frozen at 80° C. Coronal sections 20 μm thick were cut at 400 μm intervals in a cryostat at −20° C., dried on a hot plate at 60° C., fixed in 90% ethanol for 10 minutes and stained with hematoxylin and eosin (7). Infarcted brain is pale compared to the rest of the brain. The amount of infarcted brain was determined by microscopic inspection of the brain sections and calculation of infarct volumes in mm 3 . The results are shown in Tables 1 and 2 below. The numbers vary between groups because not all animals experienced a drop in MCA blood flow with the procedure. All animals were treated with DMMDPB dosages of 1000 mg/kg/day for 7 days. TABLE 1 Effect of DMMDPB on Death due to Cerebral Ischemia Survival at Survival at Survival at Treatment Death 24 hr 48 hr 72 hr Group Behavior n within 24 hr n (%) n (%) n (%) Control Sedated 12 9 (75%) 3 (25%) 2 (17%) 1 (8%)  (males) Phenobarbital Sedated 9 6 (67%) 3 (33%) 3 (33%) 3 (33%) (males) DMMDPB Not 17 2 (12%) 15 (88%)  10 (59%)  8 (47%) sedated Males 14 2 (24%) 12 (76%)  7 (50%) 5 (36%) Females 3 0 (0%)   3 (100%)  3 (100%)  3 (100%) Other dose ranging studies in rats treated with DMMDPB for 7 days established that female rats have substantially higher blood levels than male rats. Specifically, at a dosage of DMMDPB of 500 mg/kg the total barbiturate level in males was 59 μg/ml and females 170 μg/ml. At a dosage of 1000 mg/kg the total barbiturate level in males was 77 μg/ml and females 227 μg/ml; and at a dosage of 2000 mg/kg the total barbiturate level in males was 110 μg/ml and females 328 μg/ml. Thus females consistently had blood levels 250%-300% that of males at the same dosage. This data shows a type of “dose response effect” or “blood level response effect” whereby higher blood levels correlate to higher survival in female rats in the results tabulated above. TABLE 2 Neurologic status of the first 9 animals of Table 1 Neurologic Status (Bederson grading scale 0-3) Treatment Weight Day group Rat# (g) Day 1 Day 2 3 Pathology Placebo 1 260 3 X Died 24 hrs 2 260 3 X Died 24 hrs 3 240 3 X Died 24 hrs Pentobarbitol 1 260 0 1 1 SAH (autopsy) 2 250 2 2 2 Brain collected DMMDPB 1 270 1 1 1 Brain collected 2 230 3 3 X Died 48 hrs 3 240 2-3 3 X Died 48 hrs 4 260 2-3 3 3 Brain collected Pathology (visual and microscopic examination) shows smaller infarct volumes in animals pretreated with pentobarbitol and DMMDPB. Thus, DMMDPB proved to protect the animals against death. Other data indicated that DMMDPB treated animals did not manifest sedation compared to placebo group. In contract, the pentobarbital animals were anesthetized and immobile. The neuroprotective effects at non-sedating doses were comparable to or better than the effects of the sedative pentobarbital but without the side effects-of sedation, particularly at day two. These neuroprotective effects of DMMDPB are predictive for monomethoxymethyl diphenyl barbituric acid (MMMDPB) and the presumptive pharmacologically active chemical moiety diphenyl barbituric acid (DPB), which are metabolic products of DMMDPB. Indeed, in animal studies over periods ranging from 1-30 days DMMDPB was rapidly metabolized to MMMDPB and eventually to DPB. Results from clinical studies with humans demonstrated a pattern of blood levels similar to that seen in animals: DPB>MMMDPB>DMMDPB. Again, the same pattern was shown in that blood levels of DMMDPB were minimal, while MMMDPB and DPB concentration was higher. This animal model of neuroprotection is predictive for humans because: (a) the metabolic behavior of this compound in animals is predictive of human metabolism, and (b) the anticonvulsant activity in animals correlates with anticonvulsant activity in humans. Although several sedative barbituric compounds previously found to be neuroprotective in such animal models provided some benefit in human studies, their use over even relatively short time periods is precluded by their sedative and other neurological and psychological side-effects. These side effects make prophylactic treatment infeasible for patients identified as being at high risk of stroke. According to the present invention, in contrast, the NSBs have minimal side effects in humans. Thus, it is now established that diphenyl barbituric acid and its precusors, analogues and derivatives constitute a class or family of compounds suitable for neuroprotection of humans. Example 3 Reversible Cerebral Ischemia Model Rats are pretreated as in Example 1 (above) and a similar procedure is performed except that the filament occluding the MCA is removed after 30 to 60 minutes, restoring blood flow through the MCA. Rats are then followed clinically for three days, graded for their degree of stroke and then sacrificed as in Example. The brains are removed and examined as described above. The NSB compounds are shown to be neuroprotective under these conditions. Example 4 Rats are pretreated as in Example 1 (above) and then, during ether anesthesia, the rats' vertebral arteries are electrocauterized through the alar foramina of the first cervical vertebra. Reversible clamps are then placed loosely around the common carotid arteries. After 24 hours, working with awake rats, the carotid clasps are tightened to produce 4-vessel occlusion. Following 10-30 minutes of 4-vessel occlusion, the clasps are removed and 72 hours later the animals sacrificed by perfusion fixation. Untreated rats routinely demonstrate ischemic neuronal damage after 20 or 30 minutes of 4-vessel occlusion. Multiple areas of the forebrain, including the H1 and paramedian hippocampus, striatum, and posterior neocortex are evaluated. The non-sedating barbiturates are shown to be neuroprotective under these circumstances. The embodiments illustrated and discussed in this specification are intended only to teach those skilled in the art the best way known to the inventors to make and use the invention. Nothing in this specification should be considered as limiting the scope of the present invention. The above-described embodiments of the invention may be modified or varied, and elements added or omitted, without departing from the invention, as appreciated by those skilled in the art in light of the above teachings. It is therefore to be understood that, within the scope of the claims and their equivalents, the invention may be practiced otherwise than as specifically described. REFERENCES 1. Hoff J T, Smith A L, Hankinson H L, Nielsen S L. Barbiturate protection from cerebral infarction in primates. Stroke 1975; 6:28-33 2. Levy D E, Brierley J B. Delayed pentobarbital administration limits ischemia brain damage in gerbils. 3. Lightfoote W E II, Molinari G F, Chase T N. Modification of cerebral ischemia damage by anesthetics. Stroke 1977; 8:627-628 4. Corkill G, Chikovani O K, McLeish I, McDonald L W, Youmans J R. Timing of pentobarbital administration for brain protection in experimental stroke. Surg Neurol 1976; 147-149 5. Bhardwaj A, Brannan T, Weinberger J. Pentobarbital inhibits extracellular release of dopamine in the ischemia striatum. J Neural Transom 1990; 82: 111-117 6. Masuda Y, Utsui Y, Shiraishi Y, Karasawa T, Yoshida K, Shimizu M. Relationships between plasma concentrations of diphenylhydantoin, phenobarbital, carbarnapezine, and 3-sulfmoylmethyl-1,2-benzisoxazole (AD-810), a new anticonvulsant agent, and their anticonvulsant or neurotoxic effects in experimental animals. Epilepsia 1979; 20:623-633 7. Brint S B, -Jacewicz M, Kiessling M, Tanabe J, Pulsinelli W. Focal brain ischemia in the rat: Methods for reproducible neocortical infarction using tandem occlusion of the distal middle cerebral and ipsilateral common carotid arteries. J Cerebral Blood Flow Metab 1988; 8:474-485 8. Garcia J H, Wagner S, Liu K-F, Hu X-j. Neurological deficit and extent of neuronal necrosis attributable to middle cerebral artery occlusion in rats. Statistical validation. Stroke 1995; 26:627-634 9. Garcia J H, Liu K-F, Ho K-L. Neuronal necrosis after middle cerebral artery occlusion in Wistar rats progresses at different time intervals in the caudoputamen and the cortex. Stroke 1995-26:636-643. 10. Stroke Therapy: Basic clinical and pre-clinical directions, Leonard P. Miller, ed. (Wiley 1999). 11. Ginsberg, M. D., Animal Models of Global and Focal Cerebral Ischemia, Chapter 34 in Eds. Welsh, K. M. A, Caplan, L. R., Reis, P. J., et al, Primer on Cerebrovascular Diseases, Academic Press 1997. 12. Pulsinelli W A, Brierley J B. A new model of bilateral hemispheric ischemia in the unanesthetized rat, Stroke 1979 May-June 10(3): 267-72 13. Pulsinelli, W A, Brierly J B, Plum F. Temporal Profile of neuronal damage in a model of transient forebrain ischemia, Annals of Neurology, 1982, May, 11(5) 491-8.

1a

BACKGROUND OF THE INVENTION The present invention relates generally to golf training devices, and more particularly to golf training devices for training the swing motion of a golf club. Numerous factors are involved in properly striking a golf ball. For example, proper gripping of the golf club, proper body alignment, proper addressing of the ball and proper swing motion must be combined for correct execution of a golf shot. Of these, the club grip, body alignment and addressing of the ball are established before the swing motion, while the golfer is stationary, and are easily visualized by a golfer or instructor so that correction can be made where necessary. The golfer's swing motion, however, is substantially more difficult to visualize and correct. A proper golf swing motion is typically learned through repetition so that the golf swing becomes a naturally reflexive or habitual motion. To this end, numerous teaching devices have been devised to facilitate education and instruction of a golfer for developing a habitually proper golf swing. These devices generally include a frame and an arcuate or hoop shaped swing guide supported by the frame that defines the proper swing path of the golf club. The golfer stands adjacent the swing guide, with the club in contact with the guide, and swings the club along the swing guide throughout the backswing, downswing and follow-through of the swing. Through repetitive swinging of the golf club along the proper swing path defined by the swing guide, the proper motion becomes naturally reflexive or habitual to the golfer. These golf training devices are often of complex construction and can be difficult to erect. They also do not adequately adjust to the height and positioning of the particular individual golfer, or their adjustment is complex. In addition, these devices are large and require a large amount of space for storage unless the golfer expends effort disassembling the device, only to reassemble the device the next time it is to be used. SUMMARY OF THE INVENTION Among the several objects of this invention may be noted the provision of an improved golf swing training device which facilitates training a golfer to develop a proper swing motion; the provision of such a training device which is easy to assemble and erect; the provision of such a training device that can be readily adjusted according to the height and positioning of each golfer using the device; the provision of such a training device which reduces the risk of damage to the shaft of a golf club; the provision of such a training device which is collapsible for storage and transport without disassembly; and the provision of such a training device which is less costly to manufacture. A golf swing training device of this invention generally comprises a swing guide comprising a generally ring-shaped member and means for supporting the member in position to guide the swinging of a golf club by a golfer standing in position generally within the ring with the club sliding on the ring for guiding the club for efficient stroking thereof throughout the backswing, downswing and follow-through. The supporting means comprises a base structure adapted to lie on a generally horizontal surface and a framework on the base structure for supporting the ring member in position above the base structure in a plane at a selected angle to the horizontal surface. The ring member has a lower portion in front of the golfer at a relatively low elevation with respect to the surface and an upper portion in back of the golfer at a relatively high elevation with respect to the surface. The framework comprises forward ring member support means on the base structure supporting the lower portion of the ring member and permitting variation of the angle of the plane of the ring member. Rearward articulated prop means are included for propping up the upper portion of the ring member. The rearward articulated prop means is pivoted at one end thereof constituting its lower end on the base structure for angular adjustment about a generally horizontal axis extending transversely with respect to the base structure generally adjacent the surface and pivotally connected at the other end thereof constituting its upper end to the upper portion of the ring member. Articulation of the prop means enables adjustment of the elevation of the upper portion of the ring member and the angle of the plane of the ring member. In another embodiment similar to that described above, the forward ring member support means of the golf swing training device of this invention has a lower end pivotally connected to the base structure for pivoting movement about a generally horizontal axis extending transversely with respect to the base structure generally adjacent the horizontal surface. An upper end of the forward ring member support means is connected to the lower portion of the ring member. Pivoting movement of the forward ring member support means with respect to the horizontal surface enables adjustment of the elevation and angle of the ring member. The forward ring member support means and the rearward articulated prop means are constructed and arranged such that the training device is capable of being collapsed into a generally flat configuration for storage and transport of the device. The ring member is capable of remaining connected to the framework during collapsing of the device. In yet another embodiment similar to that described above, height indicating means is provided on the framework for setting the elevation of the ring member to correspond with a predetermined height setting based on the height of the golfer. Angle indicating means is associated with the framework for setting the angle of the plane of the ring member to correspond with a predetermined angle setting based on the club being swung by the golfer. Other objects and features will be in part apparent and in part pointed out hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is front perspective of a golf swing training device of the present invention; FIG. 2 is a side view thereof showing a swing guide at a first angle and elevation with respect to the ground; FIG. 3 is a side view similar to FIG. 2 showing the swing guide at a second angle and elevation with respect to the ground; FIG. 4 is an exploded view of a coupling used for connecting the swing guide to a framework of the device; FIG. 5 is an assembled view of the coupling of FIG. 4; FIG. 6A is a fragmentary top view of a portion of the training device showing a friction lock and indicia for setting the elevation of a lower portion of the swing guide with respect to the ground, with portions removed to reveal internal construction; FIG. 6B is a fragmentary front view of another portion of the training device showing a friction lock and indicia for setting the elevation and angle of an upper portion of the swing guide with respect to the ground; FIG. 6C is a plan view of the indicia of FIG. 6B laid flat; FIG. 7 is a side view of the golf swing training device of FIG. 1 in a collapsed configuration; and FIG. 8 is the fragmentary front view of FIG. 6B without the indicia and with portions removed to reveal internal construction. Corresponding parts are indicated by corresponding reference numerals throughout the several views of the drawings. DESCRIPTION OF THE PREFERRED EMBODIMENTS Now referring to the drawings, and more particularly to FIG. 1, a golf swing training device of the present invention is generally indicated at 21. Adjustable framework, generally indicated at 23, is mounted on a base structure, generally indicated at 25 for adjustably supporting a golf swing guide, generally indicated at 27 (the base structure and framework constituting "supporting means" for the swing guide), in position to guide the swinging of a golf club by a golfer for efficient stroking throughout the backswing, downswing and follow-through. The device 21 is operable between a raised configuration, as illustrated in FIGS. 1-3, for use by the golfer and a collapsed configuration, as illustrated in FIG. 7, for transporting and storing the device when it is not in use. The swing guide 27 comprises a generally ring-shaped member 29 having a lower portion 31 supported by the framework 23 at a relatively low elevation above the ground, and an upper portion 33 supported by the framework at a relatively higher elevation above the ground so that the plane of the swing guide is angled relative to the ground. The swing guide 27 is preferably of unitary construction formed of an elongate, polyethylene tube having opposing open ends 35. The elongate tube is sufficiently flexible to permit bending of the tube into the ring shape of the member 29. A connector 37 fits tightly into the opposing ends 35 to connect the ends for holding the continuous, circular shape of the ring-shaped member 29 of the swing guide 27. The swing guide 27 thus has only a single seam 39 (e.g. at the junction of the opposing ends 35). The seam 39 is preferably centrally positioned on the upper portion 33 of the swing guide 27 so that the club shaft does not slide across the seam while moving along the swing path of the club. This aspect of the invention represents an improvement over training devices having two or more seams, or having a seam (or seams) at a location where it contacts the shaft of the club, because it reduces wear on the shaft and reduces the risk of damage to the club shaft, particularly shafts constructed of graphite or other composite materials. Internally threaded inserts 41 (see particularly FIG. 4) are secured in the swing guide 27 for receiving couplings (only one set of which is shown and indicated at 43 in FIG. 1) that pivotally connect the swing guide to the framework 23. It is to be understood that the ring-shaped member 29 of the swing guide 27 may be other than a complete circle and continuous without departing from the scope of this invention. For example, the ring-shaped member 29 may be semi-circular or otherwise arcuate and discontinuous, in which the opposing ends 35 are spaced apart and connected to the framework 23, or the member may be semi-circular or otherwise partially circular and have a substantially straight cross-bar (not shown) extending between the opposing ends so that the member is still generally continuous. The base structure 25 is assembled from tubes 47 constructed of a PVC material. The tubes 47 are connected to define a generally U-shaped structure capable of lying flat on the ground or other horizontal surface in a generally horizontal plane. For example, the base structure 35 of the illustrated embodiment includes a rear base member 49 having a pair of tubes 47 connected by a straight connector 51. Side base members 53 extend forward from the rear base member 49 in parallel, spaced-apart relationship and are connected to the rear base member by elbow connectors 57. Each side base member 53 is constructed of two tubes 47 connected by a T-connector 59. Rear pivot extensions 61 are defined by additional tubes connected to the T-connectors 59 and extending transversely inward of the side base members 53 parallel to the rear base member 49. Forward pivot extensions 63 are defined by tubes 47 connected to the forward ends of the side base members 53 by elbow connectors 65 and extending transversely inward of the side base members in generally parallel relationship with the rear pivot extensions 61. The framework 23 mounted on the base structure 25 comprises forward support members 67 (broadly, "forward ring-member support means") for supporting the lower portion 31 of the swing guide 27 and upper and lower rearward support members 69, 71, respectively (the upper and lower rearward support members broadly defining "rearward articulated prop means"), for supporting the upper portion 33 of the swing guide. The forward support members 67 are pivotally connected to the forward pivot extensions 63 by suitable T-connectors 73. A portion of each T-connector 73 functions as a sleeve that fits loosely over the respective forward pivot extension 63 to permit pivoting movement of the T-connector and respective forward support member 67 about a longitudinal rotation axis of the forward pivot extension. The T-connectors 73 abut against collars 75 fixedly attached around the extensions 63. Caps 77 are secured over the inner ends of the forward pivot extensions 63 to retain the T-connectors 73 between the collars 75 and caps against translating movement. The lower portion 31 of the swing guide 27 is pivotally connected to the upper ends of the forward support members 67 by the couplings 43, each comprising a generally cylindrical post 81 having an externally threaded fastener 83 extending longitudinally outward therefrom and sized for threadably engaging the internal threading of the insert 41 in the swing guide to secure the coupling to the swing guide. The coupling 43 has a ball-shaped end 85 connected to the post 81 opposite the fastener 83, the ball having a bore 87 extending therethrough in transverse relationship with respect to the post and fastener. The forward support members 67 are open at their upper ends for receiving the ball-shaped ends 85 of the couplings 43 and have opposing openings 89 positioned for alignment with the bores 87 of the ball-shaped ends of the couplings when the ball-shaped ends are received in the forward support members. Pins 91 are sized for insertion through the openings 89 in the forward support members 67 and the ball-shaped ends 85 of the couplings 43 to connect the lower portion 31 of the swing guide 27 to the forward support members for conjoint pivoting movement about the forward pivot extensions 63. However, the pins 91 are sufficiently smaller in diameter than the bores 87 of the couplings 43 to permit pivoting movement of the ball-shaped ends 85 (and hence the lower portion 31 of the swing guide 27) about the rotation axis of the pins relative to the upper ends of the forward support members 67 to facilitate the angle change of the swing guide with respect to the ground as the forward support members are pivoted about the forward pivot extensions 63. The upper ends of the forward support members 67 have notches 93 to provide sufficient clearance for the posts 81 of the couplings 43 as the couplings pivot about the pins 91 relative to the support members. The lower rearward support members 71 of the rearward articulated prop means are pivotally connected to the rear pivot extensions 61 of the base structure 25 by suitable T-connectors 101. A portion of each T-connector 101 functions as a sleeve that fits loosely over the respective rear pivot extension 61 to permit pivoting movement of the T-connector about a longitudinal rotation axis of the pivot extension. The T-connectors 101 each abut against the respective T-connector 59 that joins each rear pivot extension 61 to the respective side base member 53 of the base structure 25. Caps (not shown) are secured over the inner ends of the pivot extensions 61 abutting against the T-connectors 101 to secure the T-connectors against translating movement. The lower rearward support members 71 are connected to the T-connectors 101 for conjoint pivoting movement about the rear pivot extensions 61. The upper rearward support members 69 of the prop means are generally L-shaped, each comprising an upward extending member 105 and a generally horizontal member 107 (FIG. 8) defining the lower end of the upper rearward support member. Each horizontal member 107 is connected to the respective upward extending member 105 by an elbow connector 109 and extends outward in generally parallel relationship with the respective rear pivot extension 61. The horizontal members 107 of the upper rearward support members 69 are connected to the upper ends of the lower rearward support members 71 by T-connectors 111. A portion of each T-connector 111 functions as a sleeve that fits loosely over the respective horizontal member 107 of the upper rearward support member 69 to permit pivoting movement of the T-connector about a longitudinal rotation axis of the horizontal member so that the upper rearward support member is capable of pivoting movement relative to the lower rearward support member 71. The T-connectors 111 each abut against the respective elbow connector 109 joining the upward extending member 105 and horizontal member 107 of the upper rearward support member 69, and caps 113 are secured over the outer ends of the horizontal members in abutting relationship with the T-connectors to secure the T-connectors against translating movement. It is to be understood that each upper rearward support member 69 may be of unitary construction, or the horizontal members 107 may be connected to the upper ends of the lower rearward support members 71, without departing from the scope of this invention. The upper portion 33 of the swing guide 27 is connected to the upper ends of the upper rearward support members 69 by a rear set of couplings 45 (FIGS. 2 and 3) such that pivoting movement of the upper and lower rearward support members 69, 71 (e.g. articulation of the articulated prop means) causes adjustment of the angle of the swing guide 27 and adjustment of the elevation of the upper portion 33 of the swing guide relative to the ground. The articulating motion of the articulated prop means represents an improvement over training devices that utilize telescoping members because it allows for a adjustment of the swing guide 27 to a broader range of elevations and swing guide angles, including the ability to fully collapse the training device 21 to a generally flat configuration as illustrated in FIG. 7, without removing the swing guide from the framework 23. In the illustrated embodiment, the rear set of couplings connecting the upper portion 33 of the swing guide 27 to the upper ends of the upper rearward support members 69 are substantially identical to the couplings 43 connecting the lower portion 31 of the swing guide to the forward support members 67 and function in a similar manner. As seen best in FIGS. 6A and 6B, friction locks 115 releasably secure the forward support members 67 against pivoting movement relative to the forward pivot extensions 63. Each forward pivot extension 63 has an arcuate slot 131 (FIG. 6A) along a portion of its circumference, the ends of which define the limits of the pivoting movement of the forward support member 67. Each friction lock 115 comprises a washer 133 disposed in the respective forward pivot extension 63, and a bolt 135 having a head 137 sized larger than the washer opening and a threaded stem 139 extending outward from the head. The threaded stem 139 extends through the washer 133, the arcuate slot 131 in the pivot extension 63, and an opening 141 in the T-connector 73 to which the forward support member 67 is connected. A knob 117 having an internally threaded opening (not shown) is threaded onto the stem 139 of the bolt 135 so that turning of the knob pulls the head 237 of the bolt toward the knob to draw the washer 133 against the pivot extension 63 and to draw the knob against the T-connector 73. Increased turning of the knob 117 tightly clamps the forward pivot extension 63 and the T-connector 73 together in friction contact so that the T-connector can no longer pivot about the forward pivot extension. Turning the knob 117 in the opposite direction decreases the friction contact between the T-connector 73 and the forward pivot extension 63 to permit pivoting movement. Similar friction locks 119 releasably secure the upper rearward support members 69 against pivoting movement relative to the lower rearward support members 71. Locking devices other than friction devices, such as locking pins or screw fasteners, may also be used without departing from the scope of this invention. With further reference to FIGS. 6A, 6B, and 6C, proper adjustment of the elevation of the swing guide 27 and the angle of the swing guide plane is facilitated by indicia on the training device. Height adjusting indicia 121 (broadly "height indicating means") comprise lettering (e.g. "A", "B", "C") wherein each letter corresponds to a pre-determined, recommended elevation of the swing guide 27 above the ground based on the height of the golfer using the training device. For example, in the illustrated embodiment, the height adjusting indicia 121 includes a first set of labels 123 (FIG. 6A) associated with the adjustment of the elevation of the lower portion 31 of the swing guide 27 and a second set of labels 125 (FIG. 6B) associated with the adjustment of the elevation of the upper portion 33 of the swing guide. The first set of labels 123 includes a label on each of the pivotable T-connectors 73 connecting the forward support members 67 to the forward pivot extensions 63 having the letters "A", "B", and "C", and a corresponding label on each of the collars 75 having an indicator, such as an arrow or other suitable notation. Registration of the letter with the arrow indicates that the lower portion 31 of the swing guide 27 is at the predetermined, recommended elevation. The second set of labels 125 includes a label on each of the pivotable T-connectors 111 connecting the upper and lower rearward support members 69, 71 having the letters "A" and "C" and a corresponding label on each of the elbow connectors 109 against which the T-connectors 111 abut having the letter "B" (FIG. 6C) . The letters on this second set of labels 125 are preferably color coded (e.g. the "A" is black, the "B" is blue and the "C" is red) for reasons which will become apparent, and correspond directly with the lettering on the first set of labels 123. Angle adjusting indicia 127 (broadly, "angle indicating means") comprises numbering corresponding to a pre-determined, recommended angle of the swing guide relative to the ground based on the golf club being used by the golfer. In the illustrated embodiment, three sets of angle numbering, each covering a range of angles from 46-70 degrees, appear on the second set of labels 125 along with the lettering used for adjusting the elevation of the upper portion 33 of the swing guide 27. The numbering is color coded in accordance with the color coding of the lettering wherein a particular colored set of numbering appears on the label opposite the label having the same colored letter. For example, a red set of angle numbering and a black set of angle numbering appears on the label having the blue "B" and a blue set of angle numbering appears on the label having the black "A" and red "C." Use of the letter corresponding to the letter used for the first set of labels 123 assures proper elevation of the upper portion 33 of the swing guide 27, and registration of the letter with the desired angle of the same color indicates that the angle of the swing guide plane is properly adjusted. In operation, the golfer determines a recommended elevation setting (e.g. "A", "B", or "C") based on the golfer's height and a recommended angle setting for the swing guide plane based on the golf club being used by the golfer. The knobs 117 of the friction locks 115 associated with the forward support members 67 are turned so as to decrease the frictional contact between the T-connectors 73 and the forward pivot extensions 63. The forward support members 67 are pivoted about the rotation axis of the forward pivot extensions 63 until the designated letter of the height adjusting indicia 121 on the first set of labels 123 (e.g. the designated letter) is properly registered so that the lower portion 31 of the swing guide 27 is adjusted to the predetermined elevation above the ground. As the lower portion 31 of the swing guide 27 is raised or lowered with the pivoting of the forward support members 67, the ball-shaped ends 85 of the couplings 43 connecting the lower portion of the swing guide to the upper ends of the forward support members 67 pivot about the rotation axis of the pins 91 to facilitate proper adjustment of the elevation of the lower portion of the swing guide. The knobs 117 of the friction locks 115 are then turned to increase the frictional contact between the T-connectors 73 and the forward pivot extensions 63 to secure the forward support members 67 and lower portion 31 of the swing guide 27 at the desired position. The golfer determines the recommended angle setting for the swing guide plane and also notes the color of letter on the second set labels 125 corresponding to the letter of the first set of labels 123 used for setting the elevation of the lower portion 31 of the swing guide 27. For example, if height setting "B" of the first set of labels 123 was used in adjusting the elevation of the lower portion 31 of the swing guide 27, then the blue "B" on the second set of labels (FIG. 6C) and the corresponding blue set of angle markings are used in adjusting the elevation of the upper portion 33 of the swing guide and the angle of the swing guide plane. If a driver is to be used by the golfer, then the 54 degree angle marking (in the set of blue angle markings) is used. The knobs 117 of the friction locks 119 associated with the upper rearward support members 69 are then turned so as to decrease the frictional contact between the T-connectors 111 and the horizontal members 107 of the upper rearward support members. The upper rearward support members 69 are then pivoted with respect to the lower rearward support members 71 until the appropriate angle marking (i.e. the blue 54 degree marking) is in registry with the appropriate height setting marking (i.e. the blue "B"). As the upper rearward support members 69 pivot with respect to the lower rearward support members 71, the lower rearward support members pivot freely about the rear pivot extensions 61. The ball-shaped ends 85 of the rear set of couplings connecting the upper portion 33 of the swing guide 27 to the upper rearward support members 69 pivot about the pins to facilitate proper adjustment of the elevation of the upper portion of the swing guide and the angle of the swing guide plane. The knobs 117 of the friction locks 119 are then turned so as to increase the frictional contact between the T-connectors 111 the upper rearward support members 69 to secure the upper and lower rearward support members and the upper portion 33 of the swing guide 27 at the desired position. The golfer then stands generally within the swing guide 27, facing toward the lower portion 31 of the swing guide. The golfer grips the club and lets the head of the club rest on the ground, with the shaft of the club lying in contact with the lower portion 31 of the swing guide 27. The golfer then swings the club through the backswing, downswing and follow-through, maintaining the shaft in contact with the swing guide 27 so that the swing guide guides the club through the proper swing path. Repetition of this exercise helps to "groove" the swing so that the proper swing path is naturally repeated without the swing guide. With reference to FIG. 7, to collapse the training device 21 for transport and storage, the knobs 117 of the friction locks 115, 119 are turned to decrease the friction between the between the T-connectors 73 and the forward pivot extensions 63 and between the T-connectors 111 and the lower ends of the upper rearward support members 69. The swing guide 27 is then pushed downward so that the forward support members 67 pivot forward relative to the forward pivot extension 63 until the forward support members lie generally flat on the ground. The lower rearward support members 71 pivot backward relative to the rearward pivot extensions 61 and the upper rearward support members 69 pivot forward relative to the lower rearward support members until the lower rearward support members contact the rear base member 49 and the swing guide 27 lies generally horizontal with respect to the ground. The training device 21 is thus in a collapsed, generally horizontal configuration which is easily transported and stored. While the golf swing training device 21 of the present invention is shown and described herein as being generally symmetrical, it is to be understood that the forward support members 67 are adjustable independent of each other, as are the upper and lower rearward support members 69, 71, so that one side of the swing guide 27 may be adjusted differently from the other side of the swing guide without departing from the scope of this invention. It will be observed from the foregoing that the golf swing training device 21 shown and described herein satisfies the several various objectives of the invention and provides other advantageous results. Providing forward support members 67 that are pivotable with respect to the ground, along with upper and lower rearward support members 69, 71 that are also pivotable with respect to the ground, permits the device to be collapsed to a generally flat configuration without removing the swing guide 27 from the framework or disassembling any portion of the device 21. As such, once the device 21 is initially assembled, there is no need to disassemble and reassemble the device each time it is stored and then reused. The flat, collapsed configuration also provides a low profile so that the device 21 is easily transported and takes up only a narrow amount of space for efficient storage of the device. The adjustable framework 23 allows both the angle of the swing guide 27 and the elevation of the swing guide to be adjusted to numerous positions depending on the height of the golfer and the club being used by the golfer. However, only six support members 67, 69, 71 are used to support the swing guide 27, with the base structure 25 providing substantial support for the framework 23 to insure stability of the device 23, thereby reducing the cost of manufacturing the training device. In addition, the height adjusting and angle adjusting indicia 121, 127 provide the golfer with positive visual identification of the elevation and angle of the swing guide 27, as well as an easy method for determining the proper elevation and angle of the swing guide. 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 or 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 My invention relates to injecting needles for injecting fluids into the human body and, more particularly, to such an injecting needle carrying an inclinometer which indicates to the physican the angle at which the needle is inserted into the skin. 2. Description of the Prior Art The anesthesiologist is frequently required to inject deep nerves with a local anesthetic solution or a neurolytic solution for nerve blockade. A successful nerve block depends on correct placement of the injecting needle. In particular, many blocks of nerves near skeletal structures require precise insertion of the injecting needle; that is, the needle must be inserted at a specific angle to the skin so that the needle is directed toward the required nerve. For example, in caudal epidural anesthesia the needle is inserted into the caudal canal at an angle of 30 to 45 degrees in the female and 10 to 20 degrees in the male. In intercostal nerve blocks the needle forms an 80 degree angle with the skin. In a celiac plexus block the needle is introduced at an angle of 45 degrees and increased to 60 degrees when the needle contacts the lumbar vertebra. In a paravertebral lumbar sympathetic ganglion block the needle is inserted at an angle of 45 degrees to the skin, and, when the transverse process is contacted, the angle is changed to 85 degrees. U.S. Pat. no. 4,031,890 discloses an I.V. injector which is provided with a safety disc so that the angle of entry of the cannula with respect to the skin surface always will be at least 45 degrees. U.S. Pat No. 2,411,165 discloses a gravity-responsive clinometer in which the angle of inclination is determined by the position of a ball confined within a curved slot provided with a scale graduated in degrees. SUMMARY OF THE INVENTION Therefore, the primary object of my invention is to provide an injecting needle with an inclinometer which will indicate to the doctor the angle of inclination of the needle relative to the patient's skin. Another object of my invention is to provide such an inclinometer in the form of an inexpensive gravity-responsive inclinometer in the form of a transparent arcuate tube containing a ball whose position in the tube indicates the angle of inclination to the physician. A further object of my invention is to provide such a inclinometer in the form of a coupling which can be inserted between the syringe and needle of a conventional injecting needle and syringe assembly. An additional object is to provide such an inclinometer which can be detached from the coupling once the needle has been inserted at the desired angle. Still another object of my invention is to provide the coupling with a manually controllable valve and with means for attaching a second syringe thereto after the contents of the first syringe have been injected, the valve functioning selectively to provide a second flow path for directing the contents of the second syringe into the injecting needle. My invention may be broadly summarized as an injecting needle and syringe assembly including an inclinometer for indicating to the physician the angle of inclination of the needle relative to the patient's skin. Other features of my invention include: a coupling which can be inserted between the syringe and needle of a conventional injecting needle and syringe assembly, the coupling serving as the means for detachably mounting the inclinometer on the assembly; and providing the coupling with means for attaching thereto an additional syringe whose contents can be directed into the injecting needle by the operation of a valve formed in the coupling. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a side elevational view illustrating one embodiment of my invention; i.e. a conventional syringe and injecting needle assembly modified to incorporate a gravity-responsive inclinometer for indicating the inclination angle α relative to the patient's skin. FIG. 2 is a top view of FIG. 1 and is partially exploded to show the coupling on which the inclinometer is mounted. FIG. 3 is a sectional view taken along line 3--3 of FIG. 2. FIG. 4 is a partial top view illustrating the detachable nature of the inclinometer. FIG. 5 is a side elevational view showing a second embodiment of the invention wherein the coupling of the preceding figures has been modified to include means for attaching thereto a second syringe. FIG. 6 is an opposite side elevational view of FIG. 5. FIG. 7 is a top view of FIGS. 5 and 6; and FIG. 8 is a cross-sectional view taken along line 8--8 of FIG. 7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 illustrates the basic elements of the preferred embodiment of the broadest feature of my invention. A conventional syringe and injecting needle assembly includes a disposable injection syringe assembly 10 and an injection needle assembly 12 which are normally directly detachably coupled together. The needle assembly 12 includes a plastic bushing 14 to which the injection needle 16 is fixed. In this illustration, the needle 16 forms an angle (90°-α) relative to the plane 18 of the patient's skin, where α is the angular displacement of the needle from the perpendicular to plane 18. A plastic coupling tube 21 is inserted between the syringe assembly 10 and the bushing 14, thereby interconnecting the syringe assembly 10 and the needle assembly 12 and permitting the fluid in the syringe assembly to pass through the coupling tube 20 and into the needle assembly 12. An inclinometer 22 is secured to the coupling 12 and provides to the physician an indication of the angle α. Inclinometer 12 consists of an arcuate transparent hollow tube 22 in which is disposed a steel ball 24 which rolls freely along the tube's lower surface portion which functions as a track for the ball. Along the curved length of the tube are graduations 26 calibrated in + or - degrees of the inclination angle α from the perpendicular. Since the inclinometer 22 is fixed to the coupling tube 20, the inclinometer tube 22 will move in a vertical plane as the needle 16 is rotated through the angle α. Since the ball 24 is loosely disposed within the tube and freely rollable therein, the tube 22 will move relative to the ball which gravity will cause always to seek the lowest point within the tube, assuming the plane 18 is vertical. Thus, the position of ball 24 within the tube 22 will be a measure of the angle α which, for the illustrated example, is approximately ±20 degrees, indicating that the needle is inclined upwardly or in the clockwise direction 20 degrees from the normal or perpendicular to the skin plane 18. If the needle were inclined at the same angle α from the perpendicular, but in the downward or counterclockwise direction, the ball would be opposite the -20 degree graduation. Of course, if the needle were horizontal, i.e. perpendicular to the vertical skin plane 18, then the ball would be opposite the 90 degree graduation. The graduations may be marked with any desired scale, such as degrees from the plane of the skin. The graduations can be calibrated according to any particular curve of the tube 22 so that the ball 24 will always indicate a measure of the angle of inclination. FIG. 2 and 3 show in more detail the construction of the coupling tube 20 and the manner in which the inclinometer 22 is mounted thereon. The larger diameter left end 30 of tube 20 slides over the tapered male connecting tube 28, which is an integral part of the plastic syringe assembly 10, such that a friction fit is formed so that tube 28 and end 30 form a tight, leak-proof friction fit. The right hand or male end 32 of the coupling tube 20 is tapered and forms a tight friction fit with the interior of the needle bushing 14. Molded integrally with the tube coupling 20 is a projecting post 34 which forms a friction fit with a bushing 36 molded integrally with the plastic tube 23. Post 34 has an axial recess 38 along its surface for receiving a matching key or radially inwardly projection 39 of bushing 36, thereby preventing rotation of the inclinometer bushing 36 relative to the mounting post 34, but permitting the physician to remove the inclinometer from the post by applying outward force to overcome the friction fit of the two members. Such a construction permits the physician to remove the inclinometer, if desired, after the needle has been inserted in the patient's skin at the desired angle. FIG. 4 illustrates the detachable nature of the inclinometer. FIGS. 5-8 illustrate another embodiment of my invention and the same reference numerals are used to indicate corresponding parts of the two embodiments. In this second embodiment, a modified coupling tube 20' is inserted between the syringe assembly 10 and the needle assembly 12 in the same manner as already described. However, also molded integrally with the coupling tube 20' are an outwardly projecting bushing 40 and a 3-way stopcock or valve assembly 42. The open end 44 of the bushing 40 has the same internal diameter as the open end 30 of the coupling tube 20 (FIG. 2) and, therefore, can receive the tapered male connecting tube 28 of a second conventional syringe assembly 10'. The bore of the bushing 40 is in selective fluid communication with the bore through the coupling 20' via the 3-way stopcock 42. This feature allows a physician to attach a second full syringe 10' to the needle assembly after the contents of the first syringe assembly 10 have been injected, and without having to remove the first syringe 10. The molded valve assembly 42 has an operating knob 46 containing three projections carrying arrows indicating which flow path has been selected by the rotational position of the valve. For example, in the position illustrated in FIG. 6 and 8, the flow path to the second syringe assembly 10' is blocked, while the flow path through the length of the coupling tube 20' is open so that the contents of the first syringe 10, coupled to the end 30 of the coupling tube 20', will flow through the bore 48, through the valve 42 into the needle assembly 12 attached to the tapered end 32 of the coupling tube 20'. When it is desired to inject the contents of the second syringe 10' into the patient, then the valve 42 is rotated 90 degrees counterclockwise from the position shown in FIG. 6 (clockwise in FIG. 8), thereby placing the internal bore 50 of the bushing 40 into fluid communication with the right hand portion of the bore 48 in the coupling tube 20'. The valve handle 46 is molded integrally with a valve core 52 which has three ports as clearly shown in FIG. 8. The valve core is molded within the valve casing 54, which is molded integrally with the coupling tube 20', in such a way that the valve core may be rotated relative to the casing but cannot be moved axially relative thereto. In this second embodiment, the inclinometer 22 is mounted via its bushing 36 onto post 34 formed on the bottom of the valve casing (as viewed in FIG. 7) in the same manner as described with respect to the first embodiment of FIGS. 1-4. Thus, the inclinometer can be detached, and coupling 20' can be used with or without the inclinometer. The inclinometer tube 23 may be any clear plastic, such as PVC, cellulosic acetate, propionate or butyrate. Furthermore, the ball 24 may also be made of plastic so long as the relationship between the weight of the ball and its friction with the tube 23 permits the ball easily to roll or slide under the force of gravity to remain in the lowest portion of the tube. It has been assumed that the surface of the skin to be injected is always in the vertical plane, which condition can be easily obtained by tiltable operating tables and the like. If the patient's skin surface should be in any other plane, such as a horizontal one, it is clear that the orientation of the inclinometer can be adjusted so that the position of ball 24 will always be a correct indication of the angle of inclination.

1a

BACKGROUND OF THE INVENTION [0001] The present invention relates to a water resistant sunscreen and insect repellent on a disposable applicator. More particularly, the present invention relates to a single-use disposable towel or wipe made from a non-woven, woven or porous material saturated with a combination water resistant sunscreen and insect repellent composition. The water resistant sunscreen and insect repellant composition, when rubbed over the skin, provides a thin, non-greasy film that provides protection against insect bites as well as the harmful effects of the sun. [0002] It is well known that sunlight contains ultraviolet A and ultraviolet B rays (UVA and UVB rays). Prolonged exposure to the sun's ultraviolet rays can be extremely harmful to unprotected skin, and in some cases can lead to a person developing early wrinkles, skin cancer and other skin related problems. Sunscreens and sunblocks have been developed to reduce the harmful effects of the sun on the skin—they are generally contained in lotions which vary on a scale of increasing protection from 1 to 50 (although there are questions regarding the effectiveness of products claiming protection factors above about 30). The scale is called the Sun Protection Factor (“SPF”). The SPF value of a sunscreen allows the consumer to determine the degree of sunburn protection that the user desires for a given period of time from direct exposure to the sun's ultraviolet rays. [0003] Another well known problem that arises from spending time outdoors is exposure to insects and insect bites. Mosquitoes, flies and ticks can be annoying and can cause painful bites which have the potential to spawn secondary infections or transmit diseases such as West Nile virus, Lyme disease, spotted fever and numerous other serious illnesses. Insect repellents are often used to discourage biting insects from landing on treated skin or clothing. [0004] Combination sunscreen-insect repellents are well known compositions for protecting the skin against both insect bites and the harmful effects of prolonged exposure to the sun. Generally, they are commercially available in the form of aerosols, pump sprays or lotions that have a limited effectiveness and other considerable draw-backs. Primarily, combination sunscreen and repellant compositions can be greasy, have a foul odor and are only effective for short periods of time. These compositions typically require multiple applications and are easily removed in water. This is a distinctive problem in warm or humid climates or when a person is engaged in an activity which causes them to perspire. [0005] In addition, aerosols, pump sprays and lotions can be somewhat difficult to apply. They are not easily controlled, especially around irregular surfaces such as the face. This can result in the unintentional inhalation of mist or vapors, or possibly cause excess chemical to come in contact and irritate the user's eyes. Furthermore, because of the high viscosity, lotions are sometimes ineffective in permitting the sunscreen-repellent composition from absorbing into skin surfaces that are partially covered by hair, such as the legs or chest. Lotion, even after being massaged into such areas after application, tends to intermingle with the hair. Instead of being absorbed into the skin, the lotion will merely congeal on top of the surface—providing less protection for the user. [0006] Furthermore, existing aerosols, pump sprays and lotions containing both sunscreen and insect repellent agents are inconvenient and bulky. They are relatively heavy and require a large storage area for transporting. In addition, the applicators, e.g., pump and spray bottles often break before the compositions are used up, thus wasting product. [0007] Accordingly, there exists a need for a combination sunscreen and insect repellent that is long lasting and effective, but fast, easy and safe to apply. Desirably, such a combination sunscreen and insect repellant provides a single use, one-step controlled application that is water resistant, non-greasy, pleasant smelling and cost effective. More desirably, such a composition has reasonable manufacturing and packaging costs, and uses industry standard effective and long lasting materials. BRIEF SUMMARY OF THE INVENTION [0008] A disposable personal applicator is formed from a non-woven, woven or porous fibrous material that is saturated with a composition containing a waterproof sunscreen and insect repellent. A preferred composition includes a sunscreen agent, an insect repellent agent, a solvent and a film forming agent present in an amount effective to form a thin film when the composition is applied to the skin of a person. [0009] The sunscreen agent is present in an amount effective to provide a SPF from about 5 to 50. Preferably, the sunscreen agent is present in an amount effective to provide a SPF from about 15 to 30. [0010] One suitable sunscreen agent is a composition of homosalate at a concentration of about 2.0 percent to about 15.0 percent by weight of the total composition, octinoxate at a concentration of about 7.5 percent by weight of the total composition, octisalate at a concentration of about 4.0 percent to about 5.0 percent by weight of the total composition and oxybenzone at a concentration of about 5.0 percent to about 6.0 percent by weight of the total composition. The sunscreen can include inactive ingredients, such as acrylates, octylacrylamide copolymer or an alcohol such as ethanol. [0011] A preferred insect repellent agent is DEET present in a concentration of about 5.0 to about 35.0 weight percent of the weight percent of the total composition. A suitable delivery agent is an alcohol based agent, such as ethanol. [0012] The applicator towel is a non-woven, woven or porous fibrous material. The material can be a polymeric fiber, a natural fiber, or a blend of polymeric and natural fibers. Suitable polymeric non-woven, woven or porous fibers are polyethylene fibers, polypropylene fibers or a blend thereof. The non-woven, woven or porous fibrous material can also be formed as a biodegradable material. [0013] These and other features and advantages of the present invention will be apparent from the following detailed description, in conjunction with the appended claims. DETAILED DESCRIPTION OF THE INVENTION [0014] While the present invention is susceptible of embodiment in various forms, there is hereinafter described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification of the invention and is not intended to limit the invention to the specific embodiment illustrated. [0015] It should be further understood that the title of this section of this specification, namely, “Detailed Description Of The Invention”, relates to a requirement of the United States Patent Office, and does not imply, nor should be inferred to limit the subject matter disclosed herein. [0016] The present invention provides a single use disposable personal applicator is formed as a towel or wipe made of a non-woven, woven or porous fibrous material that is saturated with a composition containing a waterproof sunscreen and insect repellent. When rubbed over a user's skin, the towel releases a thin, non-greasy film containing the combination sunscreen-repellent composition that provides the wearer with protection against insect bites as well as the harmful effects of prolonged exposure to the sun. [0017] A preferred form of the sunscreen-repellent composition contains a sun a sunscreen agent, an insect repellent agent, a solvent and a film forming agent which is present in an amount effective to form a thin film when the composition is applied to the skin of a user. The composition is saturated in a wipe, preferably a non-woven, woven or porous wipe, which is used to apply the composition to the skin. Once the wipe is rubbed over the skin, sunscreen-repellent composition is released from the wipe and absorbed into the surface of the skin. [0018] It is anticipated that a variety of sunscreen active agents can be used in the present towel composition. For example, sunscreen active agents such as aminobenzoic acid up to about 15.0 percent by weight, avobenzone up to about 3.0 percent by weight, cinoxate up to about 3.0 percent by weight, dioxybenzone up to about 3.0 percent by weight, methyl anthranilate up to about 5.0 percent by weight, octocrylene up to about 10.0 percent by weight, pandimate O up to about 8.0 percent by weight, phenyl benzimidazone sulfonic acid up to about 4.0 percent by weight, sulisobenzone up to about 10.0 percent by weight, titanium dioxide up to about 25.0 percent by weight, trolamine salicylate up to about 12.0 percent by weight and zinc oxide up to about 25.0 percent by weight are anticipated to be suitable for the present towel composition. [0019] A present applicator is a towel article having a sunscreen active agent composition of homosalate at a concentration of about 2.0 percent to about 15.0 percent by weight, octinoxate at a concentration of about 7.5 percent by weight, octisalate at a concentration of about 4.0 percent to about 5.0 percent by weight and oxybenzone at a concentration of about 5.0 percent to about 6.0 percent by weight. The inactive ingredients in the sunscreen can include, for example, acrylates, octylacrylamide copolymer, alcohol (such as ethanol) and, if desired, a fragrance. [0020] The resulting sunscreen has a long efficacy period when subjected to perspiration, underwater submersion or extreme environmental conditions having high humidity. Moreover, the sunscreen agent is present in the composition in an amount effective to provide a SPF of between about 5 and 50, and preferably about 15 to 30. [0021] A suitable insect repellent is M-toluamide, N,N-diethyl, commonly known as DEET, in an amount of about 2.0 percent to about 99.0 percent, and preferably, about 5.0 weight percent to about 35.0 weight percent. DEET is known in the art and is the active ingredient in many commercially available insect repellent products. It has been shown to be safe for direct application to human skin, and is effective in repelling biting insects such as mosquitoes, flies and ticks which may carry infectious diseases. The resulting composition containing the repellent agent has a pleasant odor, and is applied in such a manner that minimizes concerns regarding inhaling or ingesting mists or vapors. Since the DEET is combined with the sunscreen agent, the repellent agent is highly resistant to water, yet can be easily removed by scrubbing with soap and water. The composition was tested under strict laboratory conditions using appropriate protocols approved by the FDA and EPA. [0022] One solvent for use in the present formulation of the water resistant sunscreen and insect repellent composition is an alcohol such as ethanol. The solvent is present in a concentration of about 2.0 to about 80.0 percent by weight of the composition, and preferably is present in a concentration of about 60.0 percent of the composition. Suitable film forming agents are DEET and sunscreen mixtures. The film forming agent serves to protect, and is present in a concentration of about 2.0 to about 80.0 percent by weight of the composition, and preferably is present in a concentration of about 40.0 percent of the composition. [0023] The towel or wipe applicator of the present invention is a non-woven, woven or porous fibrous material which has a high wet strength and provides a pleasant feel when rubbed over the skin. It is sufficiently bulky and strong to prevent break up during use, but not too substantive to make the user reluctant to dispose of the article after single use. The fibrous material can be made from either a natural or polymeric fiber, and has a basis weight of about 15 to 90 grams per square meter (gsm). Suitable polymeric materials for forming the fibers of the non-woven, woven or porous towel or wipe are polyethylene and polypropylene. It is anticipated that other synthetic materials and natural materials having similar characteristics and weight would be equally suitable for use in the current invention, which other synthetic and natural materials are within the scope and spirit of the present invention. It is also anticipated that a readily biodegradable or dispersible material can be used for the towel to reduce environmental concerns regarding disposal or the like. [0024] The towel or wipe applicator is evenly saturated with the sunscreen-repellent composition in such a manner that the composition is released when the wipe is rubbed over the user's skin. One embodiment of the towel has the wiper (dry towel) saturated with a composition of about 1.0 to about 45.0 percent by weight of sunscreen, about 1.0 to about 45.0 percent by weight of insect repellent, about 2.0 to about 80.0 percent by weight of solvent and about 1.0 to about 80.0 percent by weight of film forming agent. A preferred towel includes the sunscreen agent mixtures in a concentration of about 38.0 percent, the alcohol solvent (e.g., ethanol) in a concentration of about 47.0 percent, and the film forming agent DEET and sunscreen mixtures in a concentration of about 31.0 percent. A present applicator includes a towel that is about 22.4 percent by weight of the applicator in total (total towel and composition), DEET that is about 15.5 percent by weight of the applicator in total; sunscreen that is about 15.5 percent by weight of the applicator in total and alcohol (e.g., ethanol) that is about 46.5 percent by weight of the applicator in total. [0025] All patents referred to herein, are hereby incorporated herein by reference, whether or not specifically done so within the text of this disclosure. [0026] In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. [0027] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments disclosed is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This is a Continuation application of U.S. Ser. No. 13/829,726, filed Mar. 14, 2013, which claims priority to Provisional Application U.S. Ser. No. 61/717,384, filed on Oct. 23, 2012, all of which are herein incorporated by reference in their entirety. FIELD OF THE INVENTION [0002] The present invention relates generally to mechanisms used in agricultural planting machines for selecting and dispensing individual seeds. More particularly, but not exclusively, the invention relates to air seed meters used to meter seeds from a row unit on agricultural row crop planters and seeders. BACKGROUND OF THE INVENTION [0003] An agricultural row crop planter is a machine built for precisely distributing seed into the ground. The row crop planter generally includes a horizontal toolbar fixed to a hitch assembly for towing behind a tractor. Row units are mounted to the toolbar. In different configurations, seed may be stored at individual hoppers on each row unit, or it may be maintained in a central hopper and delivered to the row units on an as needed basis. The row units include ground-working tools for opening and closing a seed furrow, and a seed metering system for distributing seed to the seed furrow. [0004] In its most basic form, the seed meter includes a housing and a seed disc. The housing is constructed such that it creates a reservoir to hold a seed pool. The seed disc resides within the housing and rotates about a generally horizontal central axis. As the seed disc rotates, it passes through the seed pool where it picks up individual seeds. The seeds are subsequently dispensed into a seed chute where they drop into the seed furrow. [0005] Early seed meters were comprised of mechanical means of singulating seeds. These meters were constructed such that fingers on the face of the seed disc gripped seeds as they passed through the seed pool, subsequently releasing those seeds as they passed over the seed chute. Although these mechanical seed meters are effective, they are limited in their ability to assure singulation of seeds and are prone to dispensing duplicates (i.e., multiple seeds) and/or failing to dispense at all (i.e., skips or misses). Other mechanical meters use cells in conjunction with brushes to trap seeds within the cavity and release them over the seed chute. [0006] Systems that are more recent include an air seed meter, e.g., vacuum or positive pressure meters, wherein the mechanical fingers have been replaced by a disc with apertures. A pressure differential is formed across opposite sides of the seed disc, which generates a suction force at the seed cell apertures. As unobstructed seed cells pass through the seed pool, seeds are drawn onto or against the seed cells and remain thereon until the seed cell passes through a region of the housing with a reduced pressure differential. To create this reduced pressure differential region, generally the “vacuum” (i.e., lower pressure) side of the seed disc is exposed to air pressure near, but not always at, atmospheric levels. At this point, seeds are released from the seed cell of the seed disc and into the seed chute. Compared to mechanical meters, air seed meters promote improved singulation across a wider range of speeds. A problem that exists with an air seed meter is that it can be difficult for the suction (negative) force of the seed cell to draw seeds from a stagnant seed pool. Another problem with air seed meters, and specifically the seed disc, is that seeds not released at or near the edge of the seed disc are susceptible to increased ricochet or bounce, thereby negatively impacting seed spacing. For those air seed meters that do release seeds from at or near edge of the seed disc, seeds are sometimes knocked free of the cells on the seed disc by the seed meter housing sidewall because of the close proximity of the housing sidewall to the cell. [0007] Therefore, there is a need in the art for an improved seed metering system that improves upon attaching seed from the seed pool to the seed disc. There is also a need in the art for a seed meter that retains the advantage of releasing seed from at or near the edge of the seed disk, but yet reduces the likelihood of unintentionally bumping the seed from the disc during rotation. [0008] Seed spacing in the seed furrow is controlled by varying the rotational speed of the seed disc. Most commonly, seed disc rotation is driven by connection to a common driveshaft. The driveshaft runs horizontally along the length of the toolbar to connect to each row unit, and is driven by a single motor or a ground contact wheel. In this configuration, the planting rate can be adjusted for all row units uniformly by adjusting the rotational speed of the common drive shaft. This can be a tedious task, and an operator is unlikely to adjust the gear ratio as often as necessary to maximize yields. Generally, an optimal overall rate for a given acreage will be selected prior to planting and will be maintained at that rate regardless of soil conditions. Whether using a mechanical or vacuum style seed disc, the seed disc is installed inside of the seed meter using independent fasteners and requires the use of tools to facilitate changing the disc. For example, if a farmer uses the same planter to plant corn and soybeans, he would use a different disc for the respective seed types. With planters continuing to grow in size, and more row units being added, the task of changing seed discs using independent fasteners and tools adds unnecessary burden to changing out seed discs. [0009] There is thus a need in the art for a method and apparatus for changing the seeding rate of a seed meter to account for varying conditions, while also providing an easy to change or install method for removing and inserting a seed disc of the seed meter and rigidly retaining that seed disc within the seed meter housing. [0010] As the art of planting progresses, emphasis on the ability of a seed metering system to accurately and consistently distribute seeds to the seed bed grows. Singulation of seeds by seed meters and spacing of seeds along the seed bed is critical in assuring that a farmer or operator is getting the maximum crop yield out of a given acreage of land. If seeds are located too closely together, or in duplicates, they will compete with each other for available nutrients and moisture in the soil, negatively impacting growth. If seeds are located too far apart, or skipped entirely, useful nutrients and moisture will go unused by the growing crops and the farmer will not realize full yield potential of the land. The increased use of GPS and computer software to generate yield maps has provided farmers the information necessary to determine optimal real time seed spacing for each row. [0011] Thus, there is also a need in the art for a seed meter that allows for quick and easy adjustment to adjust the spacing between seeds planted in a row. SUMMARY OF THE INVENTION [0012] It is therefore a primary object, feature, and/or advantage of the present invention to improve on or overcome the deficiencies in the art. [0013] It is another object, feature, and/or advantage of the present invention to provide a seed metering system that allows independent control of the metering rate of each row unit of a row crop planter. [0014] It is yet another object, feature, and/or advantage of the present invention to provide a vacuum seed disc that disrupts the seed pool as it passes through, thus loosening the seeds and directing the seeds towards the suction in the seed cell. [0015] It is still another object, feature, and/or advantage of the present invention to reduce the likelihood that a seed drawn onto or against a seed cell can be knocked free of the seed cell as it passes by the adjacent housing wall. [0016] It is a further object, feature, and/or advantage of the present invention to provide a seed disc having a pocket for adhering a seed to the disc and for aid in delivering the seed to the soil. [0017] It is still a further object, feature, and/or advantage of the present invention to provide a seed disc that delivers seed from an outside edge of the disc. [0018] These and/or other objects, features, and advantages of the present invention will be apparent to those skilled in the art. The present invention is not to be limited to or by these objects, features and advantages. No single embodiment need provide each and every object, feature, or advantage. [0019] According to an aspect of the invention, an air seed meter is provided. The air seed meter includes a housing defining a seed reservoir, a discharge chute, and a vacuum chamber. A seed disc is mounted in said housing for rotation about an axis and having a plurality of seed cells spaced about the axis for retaining seeds, with the disc having channels adjacent to each respective seed cell. Each respective channel is substantially inside of the seed cells and forward of its corresponding seed cell with respect to the rotational direction of the disc. Each respective channel has a length greater than its width. Each respective channel is oriented on the seed disc such that the length of the channel is at an oblique angle to a radius line of its seed cell such that the inner forward corner of the channel leads the outer forward corner with respect to the direction of rotation. [0020] According to another aspect of the invention, a seed disc for use with an air seed meter of an agricultural implement is provided. The seed disc includes a cylindrical structure having first and second sides and containing a plurality of apertures therethrough. The apertures are arranged in a radial array a distance from the axis of the structure. Channels are arranged in a radial array about the axis of the seed disc on the first side of the structure such that a respective channel is substantially radially inward and forward of a corresponding aperture. A central cylindrical aperture is included for mounting the seed disc to the seed meter. [0021] According to another aspect of the invention, an air seed meter for an agricultural planter is provided. The air seed meter includes a seed disc housed between a seed meter housing and a vacuum housing. The seed disc comprises a substantially circular member having a first side adjacent the seed meter housing and a second side adjacent the vacuum housing, and a plurality of apertures through the disc and spaced radially a distance from the axis of the member. The first side of the circular member comprises a plurality of channels arranged in a radial array about the axis of the seed disc such that a respective channel is substantially radially inward and forward of a corresponding aperture. The channels are configured to move seed adjacent the channel and to an aperture for retention until release therefrom. BRIEF DESCRIPTION OF THE DRAWINGS [0022] FIG. 1 is a perspective view of a conventional planter row unit with an air seed meter attached thereto. [0023] FIG. 2 is a side elevation view of the conventional row unit of FIG. 1 . [0024] FIG. 3 is a perspective view of an embodiment of an air seed meter. [0025] FIG. 4 is a perspective view of an embodiment of an air seed meter, showing the opposite side of FIG. 3 . [0026] FIG. 5 is a planar view of an embodiment of the interior of the housing of the seed meter according to the invention. [0027] FIG. 6 is a front planar view of an embodiment of the vacuum housing of the seed meter according to the invention. [0028] FIG. 7 is a rear elevation view of an embodiment of the interior of the vacuum housing of FIG. 6 . [0029] FIG. 8 is a side elevation view of an embodiment of the vacuum side of the seed disc. [0030] FIG. 9 is sectional view of an embodiment of the seed disc of FIG. 8 . [0031] FIG. 10 is a perspective view of an embodiment central hub for use with an air seed meter. [0032] FIG. 11 is another perspective view of an embodiment the central hub of FIG. 10 , shown in operative relation to a seed disc. [0033] FIG. 12 is a perspective view of an embodiment of the reservoir side of the seed disc. [0034] FIG. 13 is an enlarged view of a portion of the seed disc of FIG. 12 , showing the seed cells and seed channels. [0035] FIG. 14 is a perspective view of an embodiment of the seed disc of FIG. 12 including a singulation mechanism in operative relationship. [0036] FIG. 15 is a perspective view of an embodiment of the singulation mechanism of FIG. 11 . [0037] FIG. 15 a is a perspective view of another embodiment of a singulation mechanism. [0038] FIG. 16 is a perspective view of an embodiment showing the face of the singulation mechanism's rotational adjustment. [0039] FIG. 17 is a view of an embodiment showing the singulation mechanism with the rotational adjustment removed. [0040] FIG. 18 is a front partial sectional view of an embodiment of the seed disc and a unique drive in operative relations with the housing and other seed meter components hidden for clarity. [0041] FIG. 19 is a cross-sectional perspective view of another embodiment of a seed meter. [0042] FIG. 20 is a side elevation view of the reservoir side of the seed disc in FIG. 18 a. [0043] FIG. 21 is a perspective view of the vacuum side of the seed disc in FIG. 18 a. [0044] FIG. 22 is a perspective view of the vacuum housing of the seed meter in FIG. 18 a. [0045] FIGS. 23 a and 23 b are sectional perspective views of an embodiment of the interface between the seed disc and the seed meter housing. [0046] Before any independent features and embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of the construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. In addition, it is understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0047] Referring to FIG. 1 , a conventional planter row unit 10 with an air seed meter 5 is shown. The row unit 10 and air seed meter 5 , as shown in FIGS. 1 and 2 , is known in its general aspects to persons skilled in the art. The row unit 10 includes a U-bolt mount 11 for mounting the row unit 10 to a planter frame or tool bar (not shown), as it is sometimes called, which may be a steel tube of 5 by 7 inches (although other sizes are used). The mount 11 includes a faceplate 12 , which is used to mount left and right parallel linkages. Each linkage may be a four-bar linkage, such as the left one 14 shown in FIG. 1 . It is noted that the opposite (right) linkage is generally a mirror image of the linkage 14 shown in FIG. 1 . The double linkage is sometimes described as having upper parallel links and lower parallel links, and the rear ends of all four parallel links are pivotally mounted to the frame 15 of the row unit 10 . The frame 15 includes a support for an air seed meter 5 and seed hopper 16 , as well as a structure including a shank 17 for mounting a pair of ground-engaging gauge wheels 18 . The frame 15 is also mounted to a furrow-closing unit 19 , which includes a pair of inclined closing wheels 19 a , 19 b . The row unit 10 also includes a pair of furrow opener discs 9 , as shown in FIG. 2 . [0048] FIG. 3 and FIG. 4 represent a seed meter 20 according to an exemplary embodiment of the invention. The seed meter 20 of FIG. 3 and FIG. 4 includes a seed meter housing 21 , which contains the seed disc 22 and central hub 25 . The seed disc 22 and central hub 25 are exposed for illustration purposes, but would normally be concealed behind a vacuum housing 200 attached to the seed meter housing 21 . The vacuum housing 200 , shown in FIG. 6 and FIG. 7 , also includes a vacuum inlet 202 for a vacuum or other air source (not shown), an aperture 204 to allow seed disc central hub 25 to pass through, and attachment means 206 (shown to be keyhole slots) at an outer area of the vacuum housing 200 . The seed meter housing 21 and the vacuum housing 200 may be molded, such that they comprise molded plastic or other rigid materials. [0049] Seed is conveyed into a reservoir 26 on the seed meter housing 21 via an input tube (not shown) or a seed hopper ( FIG. 1 ). Once in the reservoir 26 , the seed pools adjacent the seed disc 22 near the bottom or lower portion of the seed meter housing 21 and becomes attached to the seed disc 22 as the seed disc 22 is rotated by direct drive 27 . The interior of the seed meter housing 21 without the seed disc 22 is shown in FIG. 5 , which also shows the location of the reservoir 26 inside the seed meter housing 21 . A door 167 , which may be slidable or otherwise movable, may be positioned adjacent the reservoir opening to provide access to the reservoir 26 to aid in emptying or cleaning out the reservoir 26 . FIG. 5 also shows the location and configuration of a singulator 111 , which is used to prevent multiple seeds becoming attached at a single seed cell 54 . The singulator 111 is shown in FIGS. 14-17 . Seeds are then released from the seed disc 22 as they transition through a zone 30 of the seed meter 20 having little to no pressure differential. Seeds are dropped into the seed chute 24 , which delivers them to the furrow. [0050] The vacuum housing 200 , as shown in FIG. 6 and FIG. 7 , includes a vacuum inlet 202 , which is connected to a vacuum source (not shown), such as a vacuum impeller, via vacuum hoses (not shown). The seed meter housing 21 includes a plurality of bosses 32 disposed along its periphery, as shown in FIG. 3 . The plurality of bosses 32 are configured to extend through the attachment means 206 of the vacuum housing 200 to locate the vacuum housing and, after rotation by the user, restrain it in place against the seed meter housing 21 . The attachment means 206 of the vacuum housing 200 are shown to be keyhole slots, but any other configuration can be used. The vacuum housing 200 further includes a sealing member 208 fitted into a groove on the interior of the vacuum housing 200 . The sealing member 208 contacts the seed flange 51 of the vacuum side of the seed disc 22 (see, for example, FIGS. 8 and 9 ) to define a vacuum chamber 210 in communication with the vacuum inlet 202 . The sealing member 208 is also surrounded by an annular rim 162 of the seed disc 22 to improve suction at the seed cells 54 . As seed cells 54 move into the vacuum chamber 210 , they are placed in fluid communication with the vacuum source. A plurality of apertures 211 in the chamber 210 provide for suction from the vacuum source along the length of the chamber 210 . [0051] Also mounted to the inside of the vacuum housing 200 is a remnant ejector 212 for the removal of seeds or seed remnants from a seed cell 54 after the seed cell passes the seed chute 24 and is no longer in communication with the vacuum chamber 210 . The remnant ejector 212 is housed within an ejector housing 215 formed integrally with the vacuum housing 200 . However, the ejector housing 215 may also be removable so as to allow different ejectors to be used according to different seed discs and seed types. The remnant ejector 212 interfaces with a series of seed cells 54 from the vacuum side of the seed disc (shown in FIGS. 3 and 8 ). The remnant ejector 212 includes a rotatable wheel 214 with a plurality of punches 216 about its periphery to remove seeds, seed debris, or other remnants remaining in a seed cell 54 after it passes the seed chute 24 . The remnant ejector 212 is spring-biased towards the seed disc 22 and moves synchronously with the seed disc 22 as it is rotated, i.e., the rotation of the seed disc 22 rotates the wheel 214 of the remnant ejector 212 . Furthermore, the remnant ejector 212 is rotatable about legs 218 to allow the ejector to move relative to the biasing spring, which aids in pressing the punches 216 of the wheel 214 to remain biased against the seed cells 54 of the seed disc 22 . [0052] FIG. 8 illustrates the vacuum side of the seed disc 22 . The seed disc 22 is substantially cylindrical and has opposing sides—a vacuum side shown in FIGS. 3 and 8 , and a reservoir side, which contacts a pool of seed ( FIG. 12 ). It should be noted that the “vacuum side” generally refers to the side of the disc 22 that will be adjacent the vacuum source. The seed disc 22 comprises a molded plastic or other rigid material. The seed disc 22 has a cross-sectional profile as shown in FIG. 9 . The cross-sectional profile of the seed disc 22 shows at least two zones on the seed disc 22 . The first zone is a generally flat seed flange 51 located at or near the outer radius of the seed disc 22 . A series of seed cells 54 located at the seed flange 51 comprise apertures extending from the vacuum side to the reservoir side, and are spaced radially about the circumference of the seed disc, which is generally a circle. The aperture of the seed cells 54 may be larger on the vacuum side of the disc 22 and narrow through the disc 22 such that the negative pressure on the seed side of the disc 22 is increased. Alternatively, a single-sized aperture may form the seed cell 54 . The seed flange 51 also includes an annular rim 162 extending radially outward from the plurality of seed cells 54 and which will be described later in further detail. Although in the embodiment shown in FIG. 8 a single seed cell circle is shown with seed cells 54 being positioned at an equal radius, one skilled in the art may also appreciate that seed cells could be staggered about multiple circles to create an alternating pattern. It should also be appreciated that the spacing and size of the seed cells 54 may be changed from the illustrated embodiments to accommodate different seed types and planting methods. The present seed disc and seed cells are not to be limited to the embodiments shown and described. [0053] A second zone 52 is shown by the cross-sectional profile of the seed disc 22 . The second zone is contoured and located radially inward of the seed flange 51 . The second zone 52 includes a cylindrical internal flange 55 . The internal flange 55 is formed substantially perpendicular to the seed flange 51 and is substantially concentric with the center axis of the seed disc 22 . The interior sidewall of the cylindrical interior flange 55 includes four keyways 53 running longitudinally through the interior flange 55 and spaced evenly about the inner circumference of the flange 55 . The cross-section of the keyways 53 is substantially similar to the external profile of the hub protrusions 61 as shown in FIG. 10 . While four keyways are shown in the figures, it should be appreciated that generally any number of keyways are contemplated for use with the seed disc 22 of the exemplary embodiment. When more or less keyways are used with a seed disc, the keyways can be radially spaced around the axis of the disc, or can otherwise be positioned to align with at least as many hub protrusions 61 for connecting the hub to the seed disc. [0054] The seed disc 22 can be fixed within the seed meter 20 without the use of fasteners or tools by inserting the central hub 25 of the seed meter housing 21 through the aperture 56 created by the inner flange 55 of the seed disc 22 . The keyways 53 of the inner flange 55 are shaped and aligned at 90-degree intervals to receive the protrusions 71 of the hub 25 (see, e.g., FIG. 10 ). With the central hub 25 inserted through the inner flange 55 , the protrusions will emerge from the keyways 53 . The hub 25 can then be rotated in the direction shown by the embossed arrows 57 (see, e.g., FIG. 8 ), while the seed disc 22 is restrained, such that the protrusions 71 will engage recesses or notches 81 on the rim of the interior flange 55 of the seed disc 22 , as shown in FIG. 11 . The seed disc 22 could also be rotated while the hub 25 is restrained to lock and unlock. The central hub 25 slidably mounts to a first end of a shaft 40 to fix the position of the seed disc 22 within the seed meter housing 21 . The central hub 25 is retained in place by an upper roll pin 42 passing through an aperture on the shaft 40 and lower dowel pin, located on the shaft 40 , which may otherwise be the protrusions 71 of the hub 25 . The second, opposite end of shaft 40 is rotatably and axially coupled to an integrated shaft bearing. The shaft bearing (not shown) may be a plain bearing, such as generally any cylindrical sleeve made of a low friction material, a rolling-element bearing, which uses spheres or small cylinders that rotate or roll between a shaft and the mating parts to reduce friction and allow much tighter mechanical tolerances, or a water pump-style bearing. The shaft bearing is positioned in a cavity 44 , as shown FIG. 4 . It should be appreciated that when other numbers of keyways 53 are used to aid in attaching the seed disc 22 to the seed meter 20 , the keyways may be located at other angles, such that the disc 22 or hub 25 can be rotated more or less to engage the protrusions with the recesses. [0055] Turning now to the reservoir side of the seed disc 22 , which is shown in FIG. 12 , a plurality of recesses or channels 91 are shown formed in the seed flange 51 . On the reservoir side of the seed disc 22 , the seed flange 51 includes a portion extending from the face of the disc 22 and including an inner lip 96 and an outer chamfer 94 . The outer chamfer 94 may be beveled or other angular in relation to the face of the seed disc 22 . FIG. 13 shows an enlarged view of these recesses or channels 91 . A recess or channel 91 is present for and respectfully aligned to a seed cell 54 . The recess or channel 91 is positioned substantially forward of its corresponding seed cell 54 with respect to the rotational direction (as shown by the arrow 93 of FIG. 12 ) of the seed disc 22 during operation and provides agitation of seed in a seed pool when the seed disc 22 is rotated. The channel 91 is oriented at an oblique angle with respect to the radius line that passes through the center of corresponding seed cell 54 . This angle directs seed radially outward and rearward with respect to the rotational direction 93 of the seed disc 22 during operation, such that seed is guided towards the seed cells 54 . The channels 91 as shown are substantially rectangular in shape, but could be also comprise an oval or any other shape that would aid in the directing of seed towards seed cells 54 . It should also be appreciated that the shape and configuration of the channels can aid in loosening seeds in the reservoir, while also guiding them towards the seed cells 54 . Furthermore, the channels or recesses include a ramped portion 97 generally adjacent the seed cell 54 , which is used to position the seed at the seed cell 54 during rotation of the seed disc 22 . [0056] Therefore, the channels 91 of the seed disc 22 provide numerous advantages. As the channels 91 are generally recessed areas separated by wall-like portions, they will increase agitation of the seed pool to promote the movement of the seeds from the seed pool. The recessed channels 91 will also provide a direct path from the seed pool to the seed cells 54 , which will promote good adhesion between the seed and the seed disc 22 at the seed cells 54 . This will aid in increasing the accuracy of the seed meter by increasing the likelihood that a seed will be adhered to the seed cell 54 . As the channels 91 are formed integrally with the seed disc 22 , they can be configured and numbered to match generally any number of seed cells 54 and can be oriented or sized to best match with any type of seed. In the alternative, one single channel 91 size and orientation may be configured such that it is usable with all types of seed. [0057] In addition, the reservoir side of the seed disc 22 will include an outer chamfer 94 and an extension surface 95 , which extends generally from the outer chamfer 94 to the annular lip 162 on the periphery of the seed disc 22 . The outer chamfer 94 essentially forms a “false edge” of the seed disc 22 , to better position the seed at or near the edge for better consistency during release of the seed into the chute 24 . During rotation of the seed disc 22 , and after the seeds have adhered to the seed cells 54 , the disc 22 will continue to rotate until a seed passes the zone 30 of the seed meter 20 with little to no pressure differential. At this location, the outer chamfer 94 will be directly adjacent the outer wall of the seed meter housing 21 , which positions the seed and seed cell 54 at the false “outer edge” of the seed disc 22 . Thus, the seed will become disengaged from the seed cell at the outer edge, which will decrease the likelihood of ricochet or bounce as the seed passes through the chute 24 , thereby increasing seed spacing consistency. The length of the extension surface 95 will vary based upon factors such as the amount of offset 161 , the type of seed, how close the seed cells 54 need to be to the “edge”, as well as other factors. The creation of the “false edge” provides for the seed to be released at or near the “edge” of the seed disc 22 , while still providing enough suction as the disc 22 passes adjacent the seed pool, as will be discussed below. [0058] In situations where duplicate seeds may be drawn onto or against a single seed cell 54 , a singulator 111 , such as that shown in FIGS. 5, 14, 15, and 17 can be used. The singulator 111 is configured to remove the excess seed(s) from the seed cell. The singulator 111 is mounted at and operatively connected to the seed meter housing 21 such that a first blade 112 (shown most clearly in FIG. 17 ) and a second blade 113 is adjacent to the reservoir side face of the seed flange 51 and the seed cells 54 . The blades are spaced from the face of the seed disc 22 , as well as the flange 51 and seed cells 54 . The blades 112 , 113 may be configured such that they are on opposite sides of the seed cell circle. The singulator 111 is biased towards the axis of the seed disc 22 and/or seed meter housing 21 . The biasing towards the axis of the seed disc 22 and/or seed meter housing 21 may be provided by a spring, gravity, or other tension member, such as by attaching the singulator 111 by a wire to the seed meter housing 21 . The singulator 111 is configured to have a fixed, curved rim portion 119 that at least partially surrounds the annular rim 162 of the seed disc, which aids in positioning the singulator 111 adjacent the seed cells 54 . [0059] The first blade 112 is positioned adjacent to the backside of the curved rim 119 , i.e., the side furthest from the seed disc 22 , and radially outward of the seed cell 54 circle. The first blade 112 includes an inner edge with a first set of ramps 115 and a generally curved profile similar to the circumference of the seed cell circle. Biasing the singulator 111 , including first blade 112 , generally inward towards the axis, aids in keeping the blade 112 , and thus, the ramps 115 , at the outer edge of the seed disc 22 to position the blade 112 and ramps 115 adjacent an outer area of the seed cells 54 . This aids in removing additional seeds at the seed cells 54 so that one seed is positioned at a seed cell 54 . [0060] The second blade 113 is spaced from the first blade 112 and is positioned radially inward of the seed cell circle 54 . The second blade 113 includes an inner edge (closest to the seed cell circle) with a second set of ramps 116 . It should be appreciated that the singulator 111 could have other ramp configurations for different seed types and the profile of the blades are not to be limiting to the exemplary embodiment. For example, smaller seeds such as a soybean seed may need less aggressive singulation and, therefore, fewer or smaller ramps can be used than for larger seeds like corn. It should also be appreciated that first blade 112 and second blade 113 could be comprised of a plurality of individual ramp assemblies, capable of moving independent of or in relationship with one another. For instance, a first ramp on first blade 112 could move independent of or in relationship with a second ramp on first blade 112 , or a first ramp on first blade 112 could move independent of or in relationship with a first ramp on second blade 113 . [0061] The first blade 112 and second blade 113 are attached to first and second carriages, 121 and 122 . In addition, the first and second blades 112 , 113 may be formed integrally with the carriages 121 , 122 . The blades 112 , 113 may be attached to the carriages 121 , 122 such that they can be replaced after wear and tear, or due to a change in the type of seed being using with the system. Therefore, screws, or other temporary attachments may be used to at least temporarily attach the blades to the carriages. [0062] The first and second carriages, 121 and 122 , are manipulated via a rotary adjustment 114 in a manner such that the first blade 112 adjusts radially outward as the second blade 113 simultaneously adjusts radially inward or vice versa, thus changing the width of the seed path between the first and second blades 112 , 113 for the seed cells 54 to pass through. The second blade 113 is connected to the rotary adjustment 114 via a cam or other mechanism that converts the rotational movement of the rotary adjustment 114 to a translational movement of the first 112 and/or second blade 113 . Thus, the second blade 113 (and/or first blade 112 ) moves generally towards or away from the first blade 112 in a longitudinal manner as the rotary adjustment is rotated. For example, the blades 112 , 113 may be slidably connected such that the blades slide along guides, slots, or notches in the singulator 111 . However, it is not required that both carriages, and thus, both blades move with rotation of the rotary adjustment 114 . For example, it is contemplated that only one of the blades move when the rotary adjustment 114 is rotated to either widen or narrow the distance between the blades, and thus, the ramps on the blades. Furthermore, the curved rim 119 remains fixed while the first blade 112 moves to ensure positioning of the singulator 111 adjacent the seed cells 54 . [0063] A wider seed path typically allows for less aggressive singulation, i.e., less contact by a ramp 115 , 116 with a seed(s) in the seed cell 54 . A narrower seed path typically creates more aggressive singulation, i.e., more contact by a ramp 115 , 116 of a seed(s) in a seed cell 54 . The level of aggressiveness is determined based on a number of factors, including, but not limited to, seed size, rate of seed dispensing, type of seed, and/or the amount of suction present at the seed cell 54 . However, the singulator 111 is generally configured such that only one seed is drawn onto or against the seed cell 54 and any other seeds drawn onto or against the seed cell 54 are knocked off into the seed pool. The slot 28 in the housing allows an operator to easily access the rotary adjustment 114 , so as to adjust the width of the seed path between the first and second blades 112 , 113 without removal of any parts. This allows the singulator 111 to be used in the seed meter 20 with a variety of types of seeds, e.g. corn, bean, etc., while also allowing quick and easy adjustment for the width of the path between the blades. [0064] FIG. 16 illustrates a view of the face of the rotary adjustment 114 . On the face are cam grooves 131 and 132 . These grooves 131 , 132 vary in radial distance from the center axis 134 of the rotary adjustment 114 . Rotating the rotary adjustment 114 causes the first and second carriages 121 , 122 (and thus, first and second blades 112 , 113 ) to move in a linear direction either toward or away from the axis of the seed disc 22 , which changes the width of the path between the blades 112 , 113 such that the blades can be used with different types and sizes of seeds. With the carriages restricted to linear motion, the engagement of the carriage protrusions, 141 and 142 , with the cam grooves, 131 and 132 , causes the carriages to change position relative to the rotation of the rotary adjustment 114 . The carriages 121 , 122 , and protrusions 141 , 142 can be seen in FIG. 17 . However, as noted above, when only one of the blades 112 , 113 is to be moved, only one set of grooves can be included on the face of the rotary adjustment 114 such that rotation thereof causes the protrusion in engagement with the groove to move linearly. [0065] The singulator 111 can also be a removable cartridge from the seed meter housing 21 to allow the singulator 111 to be repaired, replaced, cleaned, adjusted, etc. The singulator 111 includes attachment means 117 , such as feet extending generally from the bottom side of the singulator 111 . The feet 117 , which are shown for exemplary purposes, are configured to fit into slots 118 (see FIG. 5 ) formed integrally with or attached to the inside of the seed meter housing 21 . Therefore, to remove the singulator 111 , a set of snaps on the singulator are disengaged, allowing the singulator to be rotated and the feet 117 to remove from the slots 118 in the seed meter housing 21 , and removing the rotary adjustment 114 through an aperture in the seed meter housing 21 . To replace the singulator 111 , the feet 117 are positioned in the slots 118 , and the rotary adjustment 114 is positioned through the aperture in the seed meter housing 21 to provide access for a user to adjust the spacing between the first and second blades 112 , 113 . Furthermore, any number or configuration of snaps or other members may be added to the singulator body and/or housing to aid in retaining the singulator in place in the seed meter housing 21 . [0066] In another embodiment of a singulator mechanism, which is shown generally in FIG. 15 a , the singulator 111 does not include a set of snaps and feet 117 , but instead is secured to and within the seed meter housing 21 by a tension member 120 , such as a flat spring. In this manner, the singulator 111 can be removed from the housing by sliding clips 120 a upwardly and then towards the user with respect to boss 120 b . Singulator 111 can then be removed from the seed meter housing 21 for repair, replacement, cleaning and adjustment. In other embodiments using the tension member 120 , protrusions may extend from the interior of the seed meter housing 21 , with apertures of the tension member 120 simply snapping to or otherwise fitting on the protrusions to at least temporarily secure the singulator 111 to the seed meter housing 21 . [0067] FIG. 18 provides an illustration of the interaction between the unique drive 27 and the seed disc 22 according to an exemplary embodiment of the invention. A portion of the seed meter 20 has been sectioned away to show internal components of the assembly. As shown in FIG. 18 , the unique drive 27 is mounted externally to the seed meter housing 21 such that an output shaft 154 of the drive 27 protrudes through at least a portion of the seed meter housing 21 perpendicular to and adjacent the face of the reservoir side of seed disc 22 . An external gear 153 is mounted on or otherwise forms a portion of the output shaft 154 . Integrally molded into, or attached to in some embodiments, the reservoir side of the seed disc 22 is an internal gear feature 152 . Said internal gear 152 and said external gear 153 are positioned such that their matching gear teeth engage each other. This engagement allows direct control of the rotational speed of the seed disc 22 via control of the unique drive's 27 rotational output speed of the output shaft 154 . In an exemplary embodiment, the unique drive 27 is powered by an electric motor 151 , but one skilled in the art may appreciate that the unique drive could also derive its power from a pneumatic or hydraulic rotary motor, as well as any other type of rotary motion, including but not limited to, mechanical, cable drive, or chain. [0068] In another embodiment of a seed meter, as shown in FIG. 19 , the unique drive 27 a is mounted externally to the vacuum housing 200 a such that the output shaft 154 a protrudes through the vacuum housing 200 a substantially perpendicular to and adjacent the face of the vacuum side of the seed disc 22 . An external gear 153 a is mounted on or otherwise forms a portion of the output shaft 154 a . Integrally molded into the vacuum side of the seed disc 22 a is an internal gear feature 152 a . The internal gear feature 152 a may also be a separate element that is attached to an internal ring or flange of the vacuum side of the seed disc 22 a . Said internal gear feature 152 a and said external gear 153 a are positioned such that their matching gear teeth engage each other such that the output of the unique drive 27 a rotates the seed disc 22 a . FIGS. 20-22 further depict the seed disc 22 a and vacuum housing 200 a of the modified embodiment. [0069] The control of the speed of the unique drive 27 , 27 a , and thus seed disc 22 , 22 a , allows for the spacing of the seeds during planting to be better controlled. As noted, the rotational velocity of the seed disc 22 , 22 a in relation to the speed of travel of the tractor or other equipment aids in controlling the distance between seeds in a row. Therefore, the addition of the unique drive 27 , 27 a allows an operator to control the distance by simply adjusting control of the drive 27 , 27 a . For example, an operator in a tractor could adjust the rotational speed via remote or other control interface such that the distance between seeds could be adjusted during planting. This can result in significant time savings, as the operator does not have to stop planting to adjust seed rate of the meter, thus allowing a field to be efficiently planted with varied planting conditions. [0070] Referring to FIGS. 23 a and 23 b , an enlarged and sectional view of the seed meter 20 is shown detailing the interface between the seed disc 22 and the seed meter housing 21 . In certain areas, an offset portion 161 of the outer sidewall 163 is provided to be eccentric with the outer circumference (e.g., annular rim 162 ) of the seed disc 22 . A relief member 165 , which is also shown in FIG. 5 , covers the space created by the offset portion 161 between the seed cell 54 of the seed disc 22 and the bottom edge of outer sidewall 163 . For example, as shown in FIG. 23 a , the offset portion 161 is eccentric with the seed disc 22 at the loading zone 166 , i.e., the area of the seed meter 22 where the seed pools and is agitated prior to being drawn onto or against a seed cell 54 . The area created by offset portion 161 and covered by the relief member 165 gives the seed additional room to move about and be drawn onto or against the seed cell 54 , which reduces the likelihood of the seed being knocked free from the seed cell 54 by the seed meter housing 21 during rotation of the seed disc 22 . The relief member 165 also aids in orienting the seed in the seed cell 54 such that a greater surface area of the seed will fit in the cell 54 to provide the strongest suction on the seed at the cell 54 . [0071] The relief member 165 essentially creates a false outer wall of the seed meter housing 21 . As mentioned above and shown best in FIGS. 12 and 13 , the reservoir side of the seed disc 22 will include an outer chamfer 94 and an extension 95 that ends at the annular rim 162 of the seed disc 22 . As mentioned above, the outer chamfer 94 and extension 95 creates a false edge for the seed disc 22 , which allows the seed cells 54 to be positioned generally at the outer edge of the false edge. While the false edge created by the outer chamfer 94 and extension 95 aids in releasing seed, they can make it difficult for the seed to attach to a seed cell 54 at the seed pool due to the decreased suction at the outer edge of the seed disc 22 . The offset portion 161 and relief member 165 counteract this by creating a “false wall”. The so-called false wall created by the relief member 165 will extend from the outer chamfer 94 to the outer wall of the seed meter housing 21 . The width of the false wall (relief member 165 ) will make it appear as though the seed is being attached at a location further inward on the seed disc 22 , with the relief member providing a barrier to create more suction at the seed cell 54 to increase the consistency of seed attaching to the seed cells 54 . The relief member 165 and offset 161 can extend to the entrance of the singulator 111 , which is used to ensure that only one seed is positioned at each seed cell 54 . [0072] An air seed meter for dispensing seed in a field has been provided. The exemplary embodiments shown and described contemplate numerous variations, options, and alternatives, and are not to be limited to the specific embodiments shown and described herein. For example, the improvements described herein are equally applicable to other meters, such as positive-air meters like that disclosed in U.S. Pat. No. 4,450,959 to Deckler, which is incorporated herein by reference in its entirety. The foregoing description has been presented for purposes of illustration and description, and is not intended to be exhaustive list or to limit the exemplary embodiment to precise forms disclosed. It is contemplated that other alternative processes obvious to those skilled in the art are considered to be included in the invention.

1a

RELATED APPLICATIONS This application is a continuation of pending U.S. patent application Ser. No. 467,940 filed Jan. 22, 1990 (now abandoned) which is a continuation of U.S. patent application Ser. No. 271,933 filed Nov. 16, 1988 (now abandoned) which is a continuation of U.S. patent application Ser. No. 251,195 filed Sep. 29, 1988 (now abandoned); 07/271,933 is a continuation-in-part of Ser. No. 07/226,059, filed Jul. 29, 1988 (now abandoned), which is a continuation-in-part of Ser. No. 07/126,778, filed Nov. 30, 1987 (now abandoned). BACKGROUND OF THE INVENTION This invention pertains to a device providing a sterile conduit for non-invasive entry into the uterine cavity. A number of conditions require non-invasive entry into the uterine cavity, for both therapeutic and diagnostic purposes. Such access is provided through the canal of the uteral cervix, transvaginally. For diagnostic purposes, contrast media may be injected into the cervical canal and radiography carried out, both to establish the outline of the uterine cavity and/or patency of the Fallopian tubes. Alternatively, ultrasonography can be used following gas insufflation, or a fiberoptic device can be introduced into the uterine cavity for direct inspection. Yet another means of providing access is to introduce catheters into the cervical canal, and input contrast media into the uterine cavity directly. Recently described in an article entitled "Fallopian Tubes Obstruction: Selective Salpingography and Recanalization," Radiology, May 1987, number 167, pp. 511-514, is the use of a coaxial catheter system with a wire guide for transvaginal recanalization of stenosed Fallopian tubes, also carried out through the cervical canal. This procedure usually is performed in conjunction with diagnostic radiography prior to and following recanalization. Inasmuch as the stenosis usually is a result of inflammatory changes and is one major cause of female infertility, and since surgical transabdominal recanalization of the Fallopian tubes has been shown to meet with only limited success, development of new instrumentation enabling use of non-invasive procedures, such as the radiological approach, is of major importance. Non-invasive access to the Fallopian tubes is also utilized for the purpose of artificial insemination. Typically, this procedure, which has been shown to be at least twice as effective as in vitro fertilization, involves harvesting the egg and injecting a mixture of sperm and egg into the Fallopian tubes. While this procedure can be carried out under hysteroscopic, radiographic, or ultrasonographic control, the common denominator of all these procedures is access through the cervical canal and insertion of catheters into the tubes. Another possible use of selective tubal catheterization is to inject compositions for the purpose of reversible sterilization. The internal genital organs must be protected from infectious agents normally or pathologically present in the vaginal environment. A reliably attachable conduit system for safe introduction and manipulation of catheters and other devices, and for the introduction of radiographic contrast media into the uterine cavity and the tubes for the purpose of radiography, does not yet exist. Devices for the introduction of radiographic contrast media for the purpose of uterine/tubal radiography have been described previously, but they have a number of drawbacks, and they do not allow introduction of catheters. One prior art approach involves grasping the cervix with a tennacula and inserting a rubber cannula into the cervix under tension, with the distinct disadvantages of discomfort to the patient and bleeding from the cervix, as well as incomplete sealing of the cervical canal. Another prior art device is a large diameter catheter ("Foley catheter") equipped with an occluding balloon into the cervical canal. While sealing with the balloon's inflation is adequate, the Foley catheter does not permit rectification of the uterus by traction, which is often necessary for radiodiagnostic presentation. Another prior art device, "Malmstrom's cannula", employs a cup appositioned to the cervix and held in position by vacuum, forcing a conical rubber cannula into the canal. The seal is accomplished by pressure against the cervical mucosa, but this is not always successful, especially when the entrance to the cervix has been lacerated by previous births. Also, the device is complicated, consisting of a large number of parts and requiring considerable manipulation for each resterilization which can be carried out only after thorough dismantling and cleaning. The device does not allow insertion of a catheter. Another prior art device is the Kidde cannula, devised to seal the canal's orifice with a rubber cone, and to enter the uterine canal with steel tubing. This poses a risk of injury to the uterine cavity, as described, for example, by Winfield, A. C. and Wenz, A. C., "Techniques and Complications of Hysterosalpingography," in Williams and Wilkins (eds.), Diagnostic Imaging of Infertility, 1987, pp. 9-26. This device does not permit introduction of a coaxial or single catheter for selective tubal catheterization or fiberscope introduction. SUMMARY OF THE INVENTION In accordance with the teachings of this invention, a hysterography device and method is provided which avoids the various disadvantages inherent in prior art devices, namely patient discomfort, incomplete seal-off of the cervical canal, complexity of the device, and lack of provision for introduction of catheters or fiberoptic devices. The present invention also provides a hysterography device comprising: a handle containing one or two conduits; a cup located at a first end of the handle, the cup designed to fit the cervix of a patient; means for applying a vacuum within the cup, made from soft plastic material; a cone located within the cup having a nose designed to penetrate into the introitus of the cervical canal of the patient. The present invention also provides a hysterography device comprising: a handle containing a first conduit; a cup located at a first end of the handle, the cup designed to fit the cervix of a patient, the cup being made of a soft plastic material; means for applying a vacuum within the cup; and a cone located within the cup having a nose designed to penetrate into the introitus of the cervical canal of the patient. The present invention also provides a hysterography device comprising: a handle containing a first conduit, the handle being made of a plastic material and being flexible to allow operator manipulation thereof; a cup located at a first end of the handle, the cup designed to fit the cervix of a patient; means for applying a vacuum within the cup; and a cone located within the cup having a nose designed to penetrate into the introitus of the cervical canal of the patient. The present invention also provides a hysterography device comprising: a handle containing a first conduit; a cup located at a first end of the handle, the cup designed to fit the cervix of a patient; means for applying a vacuum within the cup; a cone located within the cup having a nose designed to penetrate into the introitus of the cervical canal of the patient; and a catheter in the first conduit. The present invention also provides a method of providing non-invasive entry into the uterine cavity of a patient, comprising the steps of suction sealing a cup of a hysterography device to the cervix of the patient, the hysterography device having a handle with a first conduit therein; introducing a catheter having a lumen through the first conduit and into the uterine cavity of the patient. An object of the present invention is to provide an improved hysterography device and method. Related objects are apparent from the following description. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A is a cross-sectional view of a first embodiment of this invention; FIG. 1B is an end view of the embodiment of FIG. 1A; FIG. 2 is a cross-sectional view of a second embodiment of this invention; FIG. 3A is a cross-sectional view of a third embodiment of this invention; FIG. 3B is a cross-sectional view of the third embodiment of this invention taken from the perspective of line 3B--3B in FIG. 3A. FIG. 3C is a detail, partially cutaway side view of the distal end of the third embodiment of this invention; FIG. 4A is a side view of a fourth embodiment of this invention in a first mode; FIG. 4B is a side cross-sectional view of the fourth embodiment of this invention in a second mode; FIG. 4C is a detailed, partial outaway side view of the fourth embodiment of this invention; FIG. 4D is an end view of the fourth embodiment of this invention; FIG. 4E is a cross-sectional view of the fourth embodiment of this invention taken from the perspective of line 4E--4E in FIG. 4B; FIG. 4F is an exploded side cross-sectional detail of the fourth embodiment of this invention; FIG. 5A is an anterior view of the method of this invention; FIG. 5B is a further anterior view of the method of this invention; and FIG. 5C is a further anterior view of the method of this invention. DETAILED DESCRIPTION This invention is unique in that a novel device operates in consonance with physiological factors that are dynamic rather than morphological. Thus, the circular musculature of the cervix can be stretched by pressure exerted on the walls of the cervical canal. Such "cervical dilation" is undesirable for a seal-off. The novel device utilizes a conduit of increasingly larger diameter which dilates the canal but minimally, while the canal's dilation is to an extent prevented, compressing the circumference of the cervix, which results from the vacuum by forcing the cervix into a conical cup. In the drawing figures and specification, the reference characters used in the four embodiments are the same for similar elements, except for the use of the superscripts, 1, 2, 3, and 4 corresponding respectively to the first, second, third, and fourth embodiments. As shown in the Figures, a hysterography device constructed in accordance with the teachings of this invention includes, preferably, conduit CC which is formed along the longitudinal axis of the device, which serves as the aids, rigid or flexible leading handle H, at the top of which is cup C, designed to fit the cervix. Cup C is cylindrical in its distal portion but, over radius, becomes progressively more conical towards its base CB. The cup is made preferably from a pliable material, to allow its best adaptation to the cervix. Base CB is flat or recessed, and placed over the outlet CO (of conduit CV) through which vacuum generated by a negative pressure device is applied. This results in suction which forces the cervical mucosa against the edge of the cup, and or the cervix into the cup. Concentrically and centrally placed into cup C along the axis provided by conduit CC is cone CN whose proximal, straight part is designed to penetrate into the introitus of the cervical canal. The diameter of the cone is then gradually or stepwise increased to provide the primary seal within the canal. As the inner cone CN is pressed into the cervical canal, its increasingly greater diameter produces the secondary seal-off. Thus, the more vacuum is applied, the more the peripheral mucosa is rolled against and pressed against the inner wall of cup C, thus providing the secondary seal. Finally, the perpendicular part D of the cone, while being forced against the frontal mucosa of the cervix, acts as a third sealing surface. The cone can be produced either as one piece, or constructed from several components, with the cup either affixed to the handle H (FIGS. 1A, 1B, 3A, and 3B) or to a collar CR 2 , CR 4 surrounding the handle H (FIGS. 2, 4A, 4B, 4C, 4D, 4E and 4F). While a version of the hysterograph with the cup affixed to handle H and thus providing a fixed longitudinal relation between the tip of the conduit and the cup is useful predominantly for diagnostic purposes, a version employing a movable cup is useful when an anatomical irregularity is encountered for interventional procedures, such as selective or sub-selective catheterization. Such procedures involve manipulations, often resulting in dilation of the cervical canal. When this happens, deeper penetration of the conduit CC into the canal is necessary to provide a seal-off, without which a post-procedural diagnostic radiography could not be carried out. This can be accomplished in a "movable cup" version of the with cone CN 2 and CN 4 , shown in the second and fourth embodiments of this invention, by sliding the collar such as CR 2 or CR 4 , and thus the affixed cup, away from the tip of conduit CC. In the fourth embodiment, cone CN 4 may by moved as much as 5.5 cm in a direction away from cup C 4 . A seal between the collar CR and handle H is provided by a seal-fit of the diameters; to increase the seal, a silicone or other physiologically inert lubricant can be utilized. Conveniently, cups of several sizes can be interchangeable on the same instrument. Central conduit CC is contained in the handle H and provides a passage through which a catheter, a coaxial catheter system, or fiberoptic device can be inserted, or through which contrast media can be injected. As set forth in the incorporated May 1987 Radiology article above, one specific selection for such coaxial catheter system may comprise a first, outer catheter X having a second catheter Y therein, and further having a third catheter Z inside the second catheter (See FIGS. 4B, 5A, 5B and 5C). A wire guide W, such as a Cope-type guide wire with a flexible tip, may be located inside the third catheter. Various catheters and guide wires may be used as set forth, for example a 5-F polyethylene Torcon catheter, a 3-F Teflon catheter and a Cope-type wire guide, 0.018 and 0.025 inches (0.046 and 0.064 cm) in diameter, offered by Cook Incorporated of Bloomington, Ind. Guide wires made of a mandrel of 0.035 inch (0.089 cm) LLT-type wire onto which an 8 cm long, 0.018 or 0.025 inch wire is soldered, also offered by Cook Incorporated may be used. The tip of such guide wire may be soft and flexible platinum or other suitable material. A set of suitable catheters and guide wires offered by Cook Incorporated of Bloomington, Ind. has been developed for this invention. The set includes: 1) for catheter X, a 9.0 French radiopaque Teflon catheter which is 31.5 cm long and has a Check-Flo valve; 2) for catheter Y, a 5.5 French radiopaque braided polyethylene torque control catheter which is 50 cm long with a 3 cm non-braided tip; 3) for catheter Z, a 3.0 French radiopaque Teflon catheter which is 65 cm long; and 4) for the guide wire W, both a Cope Mandrel Wire Guide having a 0.38 mm diameter and a 90 cm length and made of stainless steel with a platinum tip, and a Curved Safe-T-J wire guide with a 0.89 mm diameter and a 90 cm length with a 1.5 mm Safe-T-J tip and being made of stainless steel. The set also includes a Tuohy-Borst Adapter for the Hysterograph. At the distal end of conduit CC, a standard Luer lock LL a is provided to afford attachment of standard syringes and/or catheter collars. The handle H is rigid or flexible and made from a plastic tube containing one or two lumina, one for CC and one for vacuum. Alternatively, the vacuum line can be an independent tube. If desired, the device conveniently consists of one or several parts, and the cup can be manufactured from suitable see-through plastic materials to allow viewing of the insertion of the conus. The device can be machined and assembled from commercially available components, or molded and produced entirely or in part by standard plastic extrusion methods. Suitable plastic materials include polycarbonate, polyacrylic resins, clear polyethylene, polyvinyl chloride, carbon fiber, fiberglass, and other organic and inorganic polymeric or monomeric compositions. The devices, intended to fit a wide range of cervical sizes, are easily manufactured and conveniently sterilized and packaged ready for one-time use or repeated use. The devices can be constructed to have a range of dimensions, as follows: ______________________________________ Approximate Approximate Range Value inDimension of Values One Embodiment______________________________________Overall length 220 to 300 mm 240 mm or 260 mmof device (DL)Outside diameter 25 to 40 mm 33 mmof cup C (do)Inside diameter 21 to 36 mm 25 mm or 30 mmof cup C (di)Length of cup C 25 to 35 mm 26 mm or 27 mmDiameter of 2 to 5 mm 2.6 mmconduit (at the tip)Length of cone CN 20 to 40 mm 20 mm or 35 mmOutside diameter 15 to 25 mm 20 mmof base CBof cone CNOutside diameter 3 to 6 mm 4 mmof tip CT of coneCNOutside diameter 6 to 12 mm 7 mmof handle H(may be oval)Length of 5 to 17 mm 15 mmcollar CRDiameter of to seal-fit the outercollar CR surface of handle H______________________________________ Various structural differences between the various illustrated embodiments are shown. For example, the cups of the first and second embodiments, C 1 and C 2 , have more curved or generally parabolic shape as compared to the cups with generally straight side walls of the third and fourth embodiments, C 3 and C 4 . Accordingly, these cups, C 3 and C 4 , have a generally straight profiled side wall defining a frustum of a cone. Furthermore, the shape and arrangement of the various perpendicular parts D varies between embodiments. For example, part D 3 is formed as part of an elongated conical saddle S 3 around nose CN 3 . Part D 4 is affixed to cup C 4 , independent of cone CN 4 and of handle H 4 , so that upon movement of cup C 4 with respect to cone CN 4 , part D 4 will remain a constant spacing with respect to cup C 4 . Part D 4 and the base of the cup define an annular space AS 4 therebetween. This annular space is in front of the opening CO 4 and serves to more evenly distribute the suction action of the vacuum around the inner circumference of the cup C 4 . Similar annular spaces, AS 1 , AS 2 , and AS 3 , in the other embodiments perform similar functions. Also, note that in FIG. 4A, conduit CV 4 has been removed, showing the stainless steel cannula which partially defines opening CO 4 . FIG. 4D shows an end view of the invention with the flexible handle H 4 and the flexible collar CR 4 flexed somewhat about the longitudinal axis of the handle. FIG. 4F shows an exploded detail view of one construction used to couple flexible, plastic collar CR 4 with cup C 4 . Collar CR 4 is inserted through a hole cut in the base of cup C 4 , with handle H 4 positioned therein. Ultrasonic welding is used to connect parts together. For example, in the fourth embodiment, fitting F 4 , bushing BU 4 , part PD 4 and part D 4 (see FIG. 4F) are ultrasonically welded together, helping to form the assembly connecting collar CR 4 , cup C 4 and perpendicular part D 4 together. Gasket G 4 provides a fluid seal around handle H 4 . The various parts to be assembled together are preferably glued by suitable adhesives, such as Loctite 401, VC-1 or the like. For example, in the third embodiment, fitting F 3 and perpendicular part D 3 are glued to handle H 3 with such adhesives. Fluid tight seals around the cup may be provided by a sealant such as silicone GE RTV #118 or similar sealants. Also, it is preferable to remove, by cutting or abrasion, any sharp bead which may exist on the inside diameter of the cup, such as cup C 3 , near the outer lip thereof to provide for a better seal with the patient's cervix. FIGS. 5A, 5B, and 5C illustrate a method of this invention being performed on a patient. The patient's vagina 21, uterus 23, and fallopian tube 25 is shown. Fallopian tube 25, as illustrated, is blocked by obstruction 27. The device illustrated is the fourth embodiment of this invention having cup C 4 , handle H 4 , collar CR 4 , perpendicular part D 4 , and soft, plastic vacuum conduit CV 4 as previously described. The cup is preferably a soft or pliable plastic to better adapt to the cervix for sealing. The handle and the surrounding collar when used are preferably flexible plastic to allow bending for greater manipulation and control during use of the present invention. FIG. 5A illustrates the hysterography device seated on the patient's cervix with handle H 4 and collar CR 4 positioned transvaginally. Cup C 4 is suction seated due to the vacuum applied by vacuum device V connected to conduit CV 4 with Luer lock LL 4b . Vacuum device V may be, for example, a hand vacuum pump such as one offered by Mityvac; Neward Enterprises, Cucamonga, Calif. and disclosed in the July 1988 issue of RadioGraphics, Volume 8, Number 4, pages 621-640. Cone CN 4 is shown recessed in cup C 4 . The coaxial catheters, catheter X, catheter Y, and catheter Z are shown in position to be inserted into conduit CC 4 . FIG. 5B illustrates cone CN 4 being moved away from cup C 4 and up into the cervical canal of the patient for the purposes of a more complete seal. Movement of the cone CN 4 is accomplished by moving handle H 4 upward with respect to collar CR 4 . Note that the collar, in the preferred embodiment, is affixed to the cup with, for example, adhesive; and likewise, the cone is affixed to the handle with, for example, adhesive. FIG. 5B also illustrates catheters X, Y, and Z inserted in the conduit in handle H 4 , and into the uterus 23. Catheter Z is inserted into fallopian tube 25 at its distal end, and is attached to a source of contrast media CM at its proximal end. Contrast media is injected into the fallopian tube 25 to allow fluoroscopic examination thereof, including diagnosis of obstruction 27. Cup C 4 and cone CN 4 provide a seal with the cervix to contain the contrast media. FIG. 5C illustrates catheter Z being detached from contrast media source CM, and having guide wire W inserted in the lumen of catheter Z. The guide wire W is advanced in the lumen, out of the distal end of catheter Z, and into the fallopian tube 25. Guide wire W is advanced against obstruction 27 with a poking action, working through the obstruction to open it. Thus treatment of the obstruction, potentially causing infertility, is accomplished. Thereafter, contrast media may be again injected, as set forth in the description accompanying FIG. 5B, to determine the extent of opening of the obstruction. As earlier described, the introduction of a fiberoptic device through the lumens of the catheters in conduit CC 4 may be done for direct visual inspection in the uterine cavity. The timing and sequence of injection of contrast media, advancing of guide wires, and introduction of fiberoptic devices may vary from case to case depending on the diagnosis and treatment required. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be practiced within the scope of the appended claims.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation Application of U.S. patent application Ser. No. 14/435,731, filed Apr. 14, 2015, which is the National Phase of International Patent Application No. PCT/EP2013/071414, filed Oct. 14, 2013, published as WO 2014/060347, which claims priority to European Application No. 12188535.4, filed Oct. 15, 2012. The contents of these applications are herein incorporated by reference in their entirety. TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to the use of Fosfestrol (diethylstilbestrol diphosphate) in curative or palliative treatment of prostate cancer in a male mammal, said treatment comprising oral administration of the Fosfestrol in a daily amount of at least 1,000 mg. [0003] The invention also provides an oral dosage unit containing at least 500 mg of Fosfestrol. BACKGROUND OF THE INVENTION [0004] Cancer is still among the major causes of death in the western world. This applies to both males and females. Due to ongoing research on new medicines and methods of treatment, life expectance of people suffering from different types of cancer has steadily increased over the years. Nevertheless, better medicines and enhanced methods of treatment are still needed. [0005] Endocrine treatment essentially adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Endocrine therapy is also known as hormonal therapy, hormone therapy and hormone treatment. DES Therapy in Prostate Cancer [0006] Among the medicines that already have been used in the treatment of cancer is diethylstilbestrol (DES). DES is a synthetic nonsteroidal estrogen that was first synthesized in 1938. It was designed to achieve castrate levels of testosterone. Androgens drive prostate cancer growth and withdrawal of androgens by surgical castration was the first androgen ablation therapy in prostate cancer treatment. DES was developed to achieve chemical castration by inhibiting testicular production of androgens. [0007] However, the role of oral administration of DES in the treatment of prostate cancer has been limited because of an association with thromboembolic toxicity. When estrogens like for example DES are given orally, they are subject to the intestinal and hepatic first-pass effect leading to high hormone concentrations in the liver promoting the synthesis of clotting proteins like fibrinogen. [0008] Non-cancer related deaths, mostly cardiovascular in origin, were increased by 36% in patients suffering from prostate cancer receiving 5 mg of DES p.o. per day (Byar D P: Proceedings: The Veterans Administration Cooperative Urological Research Group's studies of cancer of the prostate. Cancer (1973) 32:1126-30). Other studies evaluating lower doses of DES reported similar efficacy towards testosterone suppression as obtained with the 5 mg dose and acceptable thromboembolic toxicity. This led to the adoption of 3 mg per day as the most commonly used DES oral dose for treating prostate cancer. However, the thromboembolic toxicity remained a concern. [0009] DES was replaced as a first line therapy in prostate cancer when a study was published in 1984 by the Leuprolide Study Group comparing the efficacy and safety of 3 mg DES versus Leuprolide in metastatic prostate cancer, which showed similar therapeutic efficacy but a much improved safety profile for Leuprolide ( The Leuprolide Study Group (1984) Leuprolide versus diethylstilbestrol for metastatic prostate cancer. N Engl J Med; 311(20):1281-6). [0010] To overcome the objections against high concentrations of DES in the liver, recent patent applications sought ways to administer DES either by transdermal administration of DES (US20030147936A1) or buccal administration (US2011189288A1) thus avoiding the first pass metabolic effect of intestinal enzymes and the liver. Both applicants claimed that by bypassing the liver DES can be safely administered. [0011] In the first case this is achieved by a placing a controlled release implant in the vicinity of the prostate and this implant than releases over an extended period of time an unspecified minute quantity of DES near the target area. No data on the plasma concentrations is available from this publications but they will certainly not be very high. [0012] In the second case the first pass metabolism in the gut and liver are bypassed by buccal administration and adsorption of DES. DES is plasma was detected at levels of on average 11 ng DES/ml, without inducing a thromboembolic activator (Fibrinogen). Fosfestrol Therapy [0013] The aforementioned concerns regarding the cardiovascular side effects of DES have led to the development of DES-based formulations that are less prone to intestinal and hepatic first pass effect. [0014] GB 732,286 describes the synthesis of Fosfestrol (diethylstilbestrol diphosphate). Fosfestrol was developed as a prodrug of DES to achieve safe inhibition of testosterone production without causing thromboembolic side effects caused by free DES. The phosphate groups were added to inactivate DES, thereby circumventing the intestinal and hepatic first pass effect and decreasing the circulating levels of free DES. Fosfestrol itself was considered to be inactive and it was known that prostate cancer cells have increased expression of prostate acid phosphatase (PAP). It was thought that PAP would remove the phosphate groups and release DES near its side of action. [0015] With a view to its estrogenic effect on testosterone decrease an oral dose of 200 mg of Fosfestrol is deemed to be equipotent to an oral dose of 3 mg DES, resulting in a similar estrogenic side effect profile. [0016] Fosfestrol was introduced and marketed in the 1950's under the name Honvan® and has been successfully applied in the treatment of prostate cancer for many years. However, as Fosfestrol is a prodrug of DES and DES was associated with problematic side effects it was replaced as a first line therapy at the same time as DES by leuprolide therapy. [0017] Hartley-Asp et al. ( Diethylstilbestrol induces metaphase arrest and inhibits microtubule assembly, Mutation Research, 143 (1985) 231-235) investigated the effects of DES on DU-145 prostate cancer cells. They showed cytotoxic effects of DES in the prostate cancer cells through inhibition of microtubule formation. [0018] Oelschläger et al. ( New Results on the Pharmacokinetics of Fosfestrol, Urol. Int. 43 (1988), 15-21) have shown that Fosfestrol and its monophosphate exist only for a short time in small amounts in the circulating blood after intravenous administration (1.5 g per day for 10 days), whilst after oral administration (360 mg), not even traces of the phosphates could be detected in the plasma. According to the authors, the most important influence on plasma levels of Fosfestrol and its metabolites is due to the extraction function of the liver. Diethylstilbestrol conjugates enter into the entero-hepatic circle, thus forming a possible source of DES available over more than 24 h. [0019] Schulz et al. ( Evaluation of the Cytotoxic Activity of Diethylstilbestrol and Its Mono - and Diphosphate towards Prostatic Carcinoma Cells, Cancer Res 1988;48:2867-2870) showed that DES concentrations ranging up to 100 ng/ml do not influence prostate cancer cell growth and that the minimal concentration of DES to induce some cytotoxic effects is 1 μg/ml. However as explained before, to achieve such high plasma concentrations via administration of DES or Fosfestrol is commonly associated with unacceptable toxic effects. [0020] The most advanced study towards the use of intravenous Fosfestrol was published by Kattan et al ( High dose fosfestrol in phase I - II - trial for the treatment of hormone - resistant prostatic adenocarcinoma, Bull. Cancer 80 (1993), 248-54). Sixteen patients with HRPC were treated by continuous infusion of high dose Fosfestrol according to two schedules: 10 patients were included in a phase I trial of a daily escalating dose from 1.5 g daily to 4.5 g daily for 7 to 10 days. Six other patients were uniformly treated by 4 g/d for 3.5 h for 5 days. Between each course patients received 300 mg/day oral Fosfestrol and 200 mg/d salicylic acid. Of these patients 15 were evaluable, as one patient died on day 3 from tumor progression complicated by an intravascular coagulation disease. There were four objective stabilizations lasting from 2 to 10 months. Subjective improvement of pain was observed in five other patients. There was more than 50% reduction of PSA in eight patients [0021] Orlando et al. ( Low - dose continuous oral fosfestrol is highly active in ‘hormone - refractory’ prostate cancer, Annals of Oncology 11 (2000), 177-181) describe the results of a study in which thirty-eight prostate cancer patients with evidence of disease progression after ≧2 hormonal treatments (including surgical or chemical orchiectomy and a median of 3 prior treatment lines) were treated with Fosfestrol. Fosfestrol was given orally at an initial dose of 100 mg 3×daily, continuously, until the advent of progressive disease or excessive toxicity. All ongoing hormonal or cytotoxic therapy was discontinued prior to the start of Fosfestrol. In the few patients with a single PSA rise following an initial response, double-dose Fosfestrol was administered. Treatment, as with the initial dose, was again continued until progressive disease (defined as two consecutive rises of PSA over the lowest achieved value), or excessive toxicity. The authors concluded that the degree of activity seen in their series warrants further prospective evaluation of Fosfestrol in this schedule as a single agent and in combination therapy, since it compares favourably in terms of response, survival and symptomatic benefit as well as of toxicity, costs and ease of administration with many other regimens developed for patients with hormone-refractory prostate cancer. SUMMARY OF THE INVENTION [0022] The present inventors have found that Fosfestrol (diethylstilbestrol diphosphate), if administered orally in a high daily amount of at least 1,000 mg, can effectively be used in the treatment of prostate cancer, especially in the treatment of hormone resistant sub-types of initially dependent prostate cancer. [0023] Unexpectedly, the inventors have discovered that Fosfestrol, when administered in such high oral dosages, does not give rise to serious side effects, such as thromboembolic toxicity or even mortality. [0024] Without wishing to be bound by theory it is hypothesized that the toxic effects that have been observed in the past for high levels (˜3 mg daily) of orally administered DES are not so much caused by DES itself, but by oxidized DES metabolites. [0025] When DES is given orally it is subjected to intensive intestinal and hepatic metabolism. Metabolisation of orally administered DES occurs through oxidation followed by conjugation or through direct conjugation. The main oxidative reactions are hydroxylation of the aromatic rings and, at the ethyl group, subsequent conjugations. Also formation of a hexadiene has been observed. The conjugates formed are sulphates, or glucuronides or combinations of the two. [0026] The inventors believe that orally administered Fosfestrol is less prone to oxidation than orally administered DES. Thus, the same DES plasma levels can be achieved with orally administered Fosfestrol as with orally administered DES, but with substantially lower levels of oxidized DES metabolites and consequently with significantly less toxic side-effects. [0027] In addition, treatment of prostate cancer using oral administration of Fosfestrol in high doses offers advantages over intravenous administration of high doses of the same substance. More particularly, whereas DES plasma levels tend to drop sharply after discontinuation of intravenous Fosfestrol administration, this is not the case for orally administered Fosfestrol. The inventors believe that this advantage results from the fact that orally administered Fosfestrol is metabolized and that one or more of the metabolites formed act as a ‘reservoir’ for the pharmaceutically active component, i.e. DES, in that they are more gradually converted into DES than intravenously administered Fosfestrol. [0028] The present invention also relates to an oral dosage unit that contains at least 500 mg of Fosfestrol. DETAILED DESCRIPTION OF THE INVENTION [0029] A first aspect of the invention concerns Fosfestrol (diethylstilbestrol diphosphate) for use in a method of curative or palliative treatment of prostate cancer in male mammals, said method comprising orally administering Fosfestrol in a daily dosage of at least 1,000 mg. [0030] The term ‘Fosfestrol’ as used herein refers to a diethylstilbestrol moiety of which both the hydroxyl groups are phosphated. The term ‘Fosfestrol’ also encompasses pharmaceutically acceptable salts of Fosfestrol. [0031] The term ‘pharmaceutically acceptable salt’, as used herein, means those salts of compounds of the invention that are safe and effective for use in mammals and that possess the desired biological activity. Descriptions of counter ions for pharmaceutically acceptable salts of pharmaceutical compounds can be found in P. Heinrich Stahl, Camille G. Wermuth (Eds.), Handbook of Pharmaceutical Salts, Properties, Selection and Use, Wiley VCH (2002). [0032] The diethylstilbestrol moiety in the DES phosphate of the present invention may be in the trans-form or the cis-form. Naturally, also mixtures of the trans- and cis-form may be employed. [0033] The term ‘cancer’ as used herein refers to a malignant neoplasm involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. [0034] The term ‘curative treatment’ as used herein refers to a treatment that aims to cure a disease or to improve symptoms associated with a disease. [0035] The term ‘palliative treatment’ as used herein refers to a treatment or therapy that does not aim at curing a disease but rather at providing relief. [0036] The term ‘oral’ as used herein, unless indicated otherwise, is synonymous to ‘per oral’. [0037] The term ‘dosage’ as used herein refers to the amount of a pharmaceutically active substance that is administered to a mammal. Hence, the term ‘dosage’ does not include any carrier or other pharmaceutically acceptable excipient that is part of a ‘dosage unit’ to be administered. [0038] In this document and in its claims, the verb ‘to comprise’ and its conjugations are used in their non-limiting sense to mean that items following the word are included, without excluding items not specifically mentioned. In addition, reference to an element by the indefinite article ‘a’ or ‘an’ does not exclude the possibility that more than one of the element is present, unless the context clearly requires that there be one and only one of the elements. The indefinite article ‘a’ or ‘an’ thus usually means ‘at least one’. [0039] Hormone-dependent cancers refer to those types of cancer that grow faster in the presence of particular hormones. This type of cancer is usually treated with hormone therapy. Hormone therapy involves blocking in vivo production or action of these hormones. Therefore, hormone therapy actually is anti-hormone therapy. Cancer of the prostate usually is a hormone-dependent cancer and may be treated by the present method. [0040] In the case of hormone-dependent prostate cancer, androgen ablation therapy (e.g. orchiectomy, treatment with LHRH analogs or LHRH antagonists) is used as first line treatment to decrease the production of androgens, particularly testosterone, in order to stop or limit the growth of prostate cancer. Androgens are key drivers of prostate tumor growth. The androgen ablation therapies reduce the plasma levels of androgen, thereby reducing the growth potential of the prostate tumor. The androgen ablation therapies are successful for a certain period of time, however all prostate tumors eventually become resistant to this treatment approach. After failure of the androgen ablation therapy, secondary hormone treatments with anti-androgens are used to slow the growth of the prostate tumor. [0041] After exposure for a certain time to hormone therapy prostate cancer often obtain the ability to grow without hormones and are therefore called ‘hormone-independent’. Once these cancers become hormone-independent, treatment usually is switched to chemotherapy. [0042] Hormone-independent prostate cancer is also called hormone-refractory or castration-resistant prostate cancer. These terms are used interchangeably in the following and are considered to have the meaning of ‘castration-resistant prostate cancer’. Nowadays, the term ‘castration resistant’ has replaced ‘hormone refractory’ because while these prostate cancers are no longer responsive to castration treatment (reduction of available androgen/testosterone), they still show some reliance upon hormones for androgen receptor activation. [0043] The present invention encompasses the treatment of hormone-dependent as well as hormone-independent cancers. The present method is particularly suited for treatment of hormone-independent cancers, especially for treatment of hormone-independent cancers that have developed after treatment of hormone dependent cancers with hormone therapy. [0044] The present method of treatment is advantageously applied to treat a prostate cancer that does not respond to treatment with anti-androgen or an inhibitor of 17α hydroxylase/C17,20 lyase (CYP17A1), especially a prostate cancer that does not respond to treatment with an inhibitor of 17α hydroxylase/C17,20 lyase (CYP17A1), more particularly to treatment with Abiraterone. The present method is particularly suited for treatment of hormone-independent prostate cancer that has developed after treatment of hormone-dependent prostate cancer with anti-androgen or an inhibitor of 17α hydroxylase/C17,20 lyase (CYP17A1), notably Abiraterone. [0045] As explained herein before, Fosfestrol in the context of the present invention also encompasses pharmaceutically acceptable salts of Fosfestrol. Pharmaceutically acceptable salts include those formed from cations of alkali metals such as sodium, lithium, potassium, and earth alkali metals such as calcium and magnesium. [0046] In a preferred embodiment the Fosfestrol is an alkali metal salt, notably a sodium and/or a potassium salt. More preferably, the Fosfestrol is in the potassium salt form. [0047] The present method of treatment may be used to treat several kinds of mammals, e.g. humans, horses, cattle etc. The present method is particularly suited for the treatment of humans. [0048] The Fosfestrol dosage may vary depending upon the specific conditions and patients undergoing treatment. The therapeutically effective dosage of the compound can be provided as repeated doses within a prolonged treatment regimen that will yield clinically significant results. [0049] The actual dosage of the compound will vary according to factors such as the disease indication and particular status of the subject such as for example, age, size, fitness, extent of symptoms, susceptibility factors and the like, and other factors such as time and route of administration, other drugs or treatments being administered concurrently. Dosage regimens can be adjusted to provide an optimum therapeutic response. [0050] Typically, the present method comprises administering Fosfestrol in a daily oral amount of at least 1,000 mg, more preferably of 1,000-4,500 mg and most preferably of 1,000-2,000 mg. [0051] Expressed differently, it is preferred to administer Fosfestrol orally in a daily amount of at least 12.5 mg per kg of bodyweight, more preferably of 12.5-60 mg per kg of bodyweight and most preferably of 12.5-27 mg per kg of bodyweight. [0052] The duration of the present method of treatment typically exceeds 7 days. More particularly, the present method has a duration of at least 14 days, especially of at least 28 days. [0053] The aforementioned daily amount may be administered once daily of it may be administered in the form of two or more separate doses at more or less regular intervals. According to a particularly preferred embodiment, the present method of treatment comprises orally administering at least two doses per day, more preferably two doses of each at least 200 mg Fosfestrol per day, even more preferably it comprises orally administering at least 3 doses of at least 200 mg Fosfestrol per day. [0054] Another aspect of the invention relates to an oral dosage unit comprising at least 500 mg, preferably at least 800 mg and most preferably at least 1,000 mg, of Fosfestrol. [0055] The oral dosage unit of the present invention can advantageously be applied in the curative or palliative treatment of prostate cancer as defined herein before. [0056] The oral dosage units is preferably selected from the group consisting of tablets, granulates, capsules and powders and liquids. Even more preferably, the oral dosage unit is a tablet or capsule. [0057] The oral dosage units typically have a weight of between 0.5 and 2.0 g, more preferably of 0.75-1.5 g and most preferably of 0.8-1.2 g. In another embodiment, the oral dosage units comprise between 20 and 80 wt. % of pharmaceutically acceptable excipient. The pharmaceutically acceptable excipient is suitably selected from coloring agents, flavoring or taste masking agents, diluents, binders, lubricants, disintegrants, stabilizers, surfactants, glidants, plasticizers, preservatives, sweeteners and combinations thereof. [0058] The disintegrants are advantageously chosen from the group consisting of lactose, anhydrous lactose, crospovidone, croscarmellose sodium, sodium starch glycolate, hydroxypropyl cellulose, polacrilin potassium, pregelatinized starch, microcrystalline cellulose and combinations thereof. In a preferred embodiment the oral dosage units comprise up to 7 wt. %, preferably 2-5 wt. % of disintegrants. [0059] The dosage unit of the present invention may suitably take the shape of a compressed tablet. Such a tablet may suitably comprise two or more layers of different composition, for example a core comprising Fosfestrol as defined herein before encased in a coating. [0060] The dosage units of the present inventions are conveniently produced in a tabletting machine. In order to enable easy removal of the tablets from the moulds, the dosage unit typically contains between 0.2 and 4.0 wt. % of a lubricant or gliding agent. Preferably, the lubricant or gliding agent is selected from the group consisting of talc, sodium stearyl fumarate, magnesium stearate, calcium stearate, hydrogenated castor oil, hydrogenated soybean oil, polyethylene glycol, starches, anhydrous colloidal silica and combinations thereof. [0061] The following examples are meant to further illustrate the invention and some of its preferred embodiments without intending to limit its scope. EXAMPLES Example 1 [0062] The in vitro direct cytotoxicity of DES and Fosfestrol in hormone-dependent (LNCaP) and hormone-independent (DU-145) prostate cancer cell lines was tested. [0063] Cells were maintained in vitro in RPMI 1640 containing 10% (v/v) heat inactivated fetal bovine serum (FBS) and 2 mM L-glutamine (growth media) at 37° C. in 5% CO 2 and humidified conditions. Cells were harvested, washed, re-suspended into growth medium and counted. The cells were re-suspended into assay media (RPMI 1640+1% (v/v) heat inactivated FBS+ and 2 mM L-glutamine) at 0.5×10 5 cells/ml for DU-145 cells and 1×10 5 for LNCaP cells, and plated into 96-well assay plates (Corning, black-wall plates) and 50 μl/well aliquots. [0064] Plates were incubated O/N at 37° C. in 5% humidified CO 2 prior to addition of the compounds. DES was dissolved in 100% DMSO at stock concentration of 60 mM. Fosfestrol was dissolved in sterile water at stock concentration of 60 mM. Stocks of all compounds were then serially diluted. Final concentrations to which cells were exposed were: 300, 150, 75, 37.5, 18.75, 9.4, 4.7, 2.3, 1.2 and 0.6 μM. Positive control was Taxotere. Taxotere was diluted in 100% DSMO to give a stock concentration of 1 mM. Stock was serial diluted and final concentration to which cells were exposed was: 1000, 333.3, 111.1, 37.0, 12.3, 4.1, 1.4, 0.5, and 0.2 nM. [0065] Plates were incubated for 72 hrs at 37° C. in 5% humidified CO-2 after addition of the compounds. Viability of the cells was assessed with the Cell titer blue® (Promega) assay. 10 μl of Cell titer Blue™ reagents was added to each test/blank well. Plates were incubated for 3 hrs at 37° C. in 5% humidified CO 2 prior to analysis. Fluorescence was measured with a Flex II station plate reader. Excitation wavelength was 570 nm, emission wave length was 600 nm, cut off was 590 nm. Raw data was processed by GraphPad Prism to calculate mean, standard deviation and IC 50 values. [0066] The results so obtained are shown in Table 1. [0000] TABLE 1 IC 50 value (μM) LNCaP DU-145 DES 27 62 Fosfestrol 70 84 Taxotere (control) 0.002 0.004 CONCLUSION [0067] These results show that DES and Fosfestrol are both cytotoxic in LNCaP and DU-145 prostate cancer cells. Example 2 [0068] A 1 kg batch of 500 mg Fosfestrol tablets was prepared by direct compression as described below. [0069] Fosfestrol and excipients were first passed over a 0.85 mm sieve. Next, 500 gram of fosfestrol tetrasodium was blended with 435 gram of silicified Microcrystalline Cellulose (Prosolv smcc 90 ™) and 50 gram of croscarmellose sodium (Ac-di-Sol™) for 20 minutes in a V-blender. Added to the mixture was 15 grams of magnesium stearate and blending was continued for 5 minutes. [0070] Tablets of 1,000 mg each were prepared on a Korsch EKO, using oval punches. Example 3 [0071] A patient study was conducted in chemo and hormone resistant prostate cancer patients to explore the effects of high dose oral Fosfestrol treatment. [0072] 11 patients were included into the study and all had undergone at least 2 prior treatments (mostly Taxotere and Estramustine) with a maximum of prior 4 treatments. [0073] Patients were treated with three times 360 mg/d oral Fosfestrol for 4 weeks. Total Fosfestrol dose per day was 1,080 mg. All other treatments were stopped during high dose oral Fosfestrol therapy. [0074] PSA decline was used to measure objective response. 72% of the patients showed a PSA decline of >50% during high dose oral Fosfestrol treatment. In addition, 54% of the patients experienced a >80% PSA decline. [0075] Treatment was accompanied by minor toxicities and no thromboembolic side effects were detected. CONCLUSION [0076] This study showed that high dose oral Fosfestrol is effective and safe to use in heavily pretreated chemo and hormone resistant prostate cancer patients.

1a

CROSS REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority of U.S. Provisional Application No. 60/484,234 filed Jun. 30, 2003 and patent application Ser. No. not yet known filed on Jun. 30, 2004, the entire disclosure of which are hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] Adenoviruses commonly infect the eye, respiratory and gastrointestinal tracts and can infect other organs such as the liver, urinary bladder, pancreas, central nervous system and others. There are over 50 known serotypes of Human Adenoviruses of which at least 24 have been identified as pathogens. Adenovirus has been shown to persist for months after initial infection in particular in immunosuppressed patients. TABLE 1 Adenoviruses Serotypes and Disease Disease Major Serotypes* Acute febrile pharyngitis 1, 2, 3, 5 , 6, 7 Acute respiratory disease 3, 4, 7 , 14, 21 Acute hemorrhagic cystitis 11, 21 Epidemic keratoconjunctivitis 8, 11, 19, 37 Gastroenteritis 40, 41 Hepatitis 1, 2, 5 Meningoencephalitis 7 , 12, 32 Pertussis-like syndrome 5 Pharyngoconjuctival fever 3, 7 , 14 Pneumonia (children) 1, 2, 3, 7 Pneumonia (adults - military recruits) 4, 7 *Serotypes in bold with underline have been tested and shown to be sensitive to CTC-96 [0003] An example of Adenovirus-related disease [0004] Adenoviruses are the most prevalent causes of acute ocular viral disease for which there is no known cure. The actual prevalence and incidence of Epidemic Keratoconjunctivitis (EKC) caused by Adenoviruses in the US and internationally are unknown, because general practitioners and optometrists see most cases and this infection does not have to be reported to any medical authority. EKC is highly contagious and has the tendency to occur in epidemics. [0005] While EKC is a self-limiting disease that generally resolves within 1-3 weeks. the patient may remain highly infectious for 10-14 days or more after symptoms develop (I). Symptoms of EKC include conjunctival redness, swelling or redness of the eyelid, discharge from the eye, sticking together of eyelids, pain or discomfort in the eye, photophobia, or a sensation of a foreign body in the eye. In Severe cases, membranous and pseudomembranous conjunctivitis can be seen in one third of cases, which can lead to conjunctival scarring and symblepharon formation (adherence of the bulbar and palpebral conjunctivas) (2;3). Both membranes and pseudomembranes can occur in EKC with a distinguishing corneal involvement that ranges from diffuse, fine, superficial keratitis to epithelial defects to subepithelial opacities (2;3). In 20-50% of cases, corneal opacities can persist for weeks to months to several years (1;3). This phenomenon can decrease visual acuity significantly and cause glare symptoms (2). [0006] There is no specific direct antiviral chemotherapy against Adenoviruses at present. Corticosteroids may be used to limit corneal damage but have the side effects referred to above and also of interfere with viral clearance (3;4). SUMMARY OF THE INVENTION [0007] We have discovered an effective method for the treatment for Human Adenoviruses, and, in particular, Adenovirus-derived keratoconjunctivitis for both therapeutic and prophylactic purposes and respiratory disease. The treatment for adenovirus-derived keratoconjunctivitis, whether it be for therapeutic or prophylactic purposes, can be achieved by topical administration. The treatment for respiratory disease may be by injection or by nasal administration, i.e., by spray or nose drops. As used herein, the expression “therapeutic treatment” means treatment for a subject already having the disease. As used herein, the expression “prophylactic treatment” means treatment for a subject who, while not being infected by the virus, is in a situation wherein they are susceptible to or subject to the possibility of acquiring the disease, e.g., in a household where another resident is already infected with the disease. We have also shown in vitro that CTC-96 is effective against types 1, 2, 3, 4, 5, and 7, attesting to the effectiveness of CTC-96 against the adenovirus derived diseases outlined in Table 1. More particularly, we have discovered that in the eye there is a significant reduction in Adenovirus-derived keratoconjunctivitis disease can be achieved by the by the topical administration of an anti-adenovirus therapeutic or prophylactic effective amount of Compound CTC-96. [0008] As used herein, the word “therapeutic” means use of the inventive method to treat a subject who has already been infected with Adenovirus. As used herein, the word “prophylactic” means use of the inventive method to protect or decrease the likelihood of a subject who may be exposed to Adenovirus from being infected with the virus. [0009] Compound CTC-96 has the structure: wherein R 1 and R 1′ are methyl, R 2 and R 2′ are hydrogen and R 3 and R 3′ are methyl, and X and X′ are each: and Q′ is Br = . [0012] CTC-96 may be prepared by the method described in the U.S. Pat. No.5,756,491, the contents of which are hereby incorporated by reference. [0013] Generally, this compound is administered topically in the form of an aqueous solution. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a graph of Human Adenovirus titers following exposure to CTC-96 prior to cell infection; [0015] FIG. 2 is a graph of virus tiers after exposure of Human Adenovirus infected cells to CTC-96; [0016] FIG. 3 is a graph depicting the effect of treatment of Adenovirus Induced Keratoconjunctivitis with CTC-96; and [0017] FIG. 4 is a graph depicting adenovirus titers after treatment of Adenovirus infected rabbit eyes with CTC-96. DETAILED DESCRIPTION OF THE INVENTION [0018] We have demonstrated, by using Adenovirus type 5, that we can reproduce human Adenovirus Infection in rabbit eyes and have shown both excellent antiviral activity and conjunctivitis therapy using CTC-96 which we believe is unique as there is no effective drug against this virus and its pathology in the eye. In addition, we have shown CTC-96 efficacy against Adenovirus types 1, 2, 3, 4, 5, and 7 in HeLa cells in tissue culture. Since these human viruses cannot be grown in animal models, this provides an excellent indication of the effectiveness of CTC-96 against a broad spectrum of Adenovirus types. To determine CTC-96 efficacy against several types of serotypes of adevirus the following procedure was followed: 1. Hela cells were confluent at the time of inoculation. 2. Virus dilutions were prepared from the known titers of the stock viruses (4×10 5 pfu/ml; 4×10 4 /0.1 ml) of Ad1 Kmetz, Ad2 Wolf, Ad3 Holyfield, Ad4 Harris, , Ad7a Joseph, ATCC. This virus inoculation yielded a virus infection with an m.o.i. (multiplicity of infection) of approximately 1.0. 3. 100 □l of each Ad serotype were inoculated onto cultures containing Hela cells. 4. During the adsorption period, Doxovir concentrations of 500, 250, 100, 50, 10, and 0 μg/ml were prepared in culture medium according to the dilution protocol. 5. Virus was adsorbed at 37° C. in a 5% CO 2 water-vapor atmosphere for 1 hour. 6. After adsorption, the virus inocula were removed from all the wells and 2 wells each were overlayed with 1 ml of Doxovir (in tissue culture medium) at concentrations of 500, 250, 100, 50, 10, and 0 μg/ml. 7. The plates were incubated at 37° C. in a 5% CO 2 water-vapor atmosphere for 24 hours. 8. After 24 hours, the plates were washed. 9. Each well was refilled with 1 ml of fresh tissue culture medium without Doxovir. 10. The cells were scraped from the wells. 11. The media and cells were then frozen at −75° C. pending titrations. 12. Titration of duplicate samples were thawed from each Ad serotype, Doxovir concentration and its no drug control. 13. Viral titers were determined at each drug concentration. [0032] CTC-96 has considerable advantages as an anti-viral drug: a) because of its unique mode of action it Is effective against herpes and HIV virus mutants which are resistant to currently used drugs; b) because the drug acts against two different viral targets in herpes virus the development of CTC-96-resistant mutants is deemed to be extremely rare; and c) because CTC-96 has anti-inflammatory properties its use replaces the use of steroids in herpes virus and Adenovirus therapeutics. Steroids modulate the immune response in the areas where they are applied and increase tissue susceptibility to pathogens. [0033] Efficacy Studies [0034] Efficacy of CTC-96 against Adenovirus types 1, 2, 3, 4, 5, and 7 in culture [0035] Anti-adenovirus activity of CTC-96 was evaluated by standard cell culture using HeLa cells, a human cervical carcinoma immortalized cell line (the usual host for laboratory grade adenovirus) and anti-viral plaque-reduction assays. CTC-96 has an inhibitory (prophylactic) effect on growth when virus is exposed to the drug prior to cell infection. [0036] FIG. 1 shows Adenovirus type 5 titers following direct exposure of the virus to CTC-96 prior to HeLa cell infection. [0037] The data graphically depicted in FIG. 1 were obtained as follows: varying concentrations of the CTC-96 were mixed with concentrated Human Adenovirus, [Adenovirus type 5 (Ad5)] and incubated at 37° C. for 60 minutes. Aliquots were then diluted 500 fold into growth medium. Hela cells were exposed to 100 μl of the diluted material to initiate infection. These monolayers were incubated for 24 hours at 37% and 5% CO2 and then washed, scraped, sonicated, centrifuged and the supernatant serially diluted. These serial dilutions were plated onto indicator HeLa cell monolayers and adsorbed for 60 min, aspirated and a methycellulose overlay placed over the cells, which were then incubated for 3 days at 37%. Cultures were counterstained with 1% methylene blue, allowed to dry and the plaques counted. Results are expressed as mean ±SD (where error bars are not visible they are contained within data point). [0038] CTC-96 also has a potentially therapeutic effect as can be seen by inhibition of viral growth in Adenovirus infected cells, which are subsequently exposed to the drug. FIG. 2 shows virus titers obtained after exposure of human Adenovirus type 5 (Ad5) infected HeLa cells to CTC-96. These data were obtained as follows: Adenovirus was adsorbed onto HeLa cell monolayers for 60 min at 37%; serial dilutions of CTC-96 were overlaid onto the minelayers. Monolayers were then incubated for 24 hr at 37° C. and 5% CO2. Monolayers were then washed, scraped, sonicated, centrifuged and the supernatant serially diluted. These serial dilutions were plated onto indicator HeLa cell monolayers and adsorbed for 60 min, aspirated and a methylcellulose overlay placed over the cells, which were then incubated for 3 days at 37%. Cultures were counterstained with 1% methylene blue, allowed to dry and the plaques counted. Results am expressed as mean & SD (where error bars are not visible they are contained within data point). [0039] Clinical results and plaque assay viral titers of three CTC-96 treatment/dosing regimens of rabbit eyes infected with Human adenovirus, Adenovirus type 5 (Ad5), were evaluated. On “Day 1” animals were infected with Human Adenovirus Type 5 by the installation of 10 6 pfu adenovirus according to our protocol of conjunctival and corneal scarification for the induction of Keratoconjunctivitis. Clinical conjunctivitis was observed in all animals by day 8 post-inoculation. Animals were then randomized and the following experimental groups were treated with CTC-96 or placebo in a double blind experiment: (1) Placebo (diluent alone), 9×/day, for 21 days: (4 rabbits). (2) CTC-96 50 μg/ml, 9×/day, for 21 days: (4 rabbits). (3) CTC-96 50 μg/ml, 6×/day, for 21 days: (4 rabbits). (4) C T W 25 μg/ml, 6×/day, for 21 bays: (4 rabbits). [0044] Clinical disease progression and resolution were evaluated by slit lamp microscopy on days 1,3,7,10,13,18,21,24,28 and 31 after initial drug dosing. The intensity of the keratitis was quantified using a clinical grading system (5). [0045] Application of 25 μg/ml and 50 μg/ml prevented progression of disease severity. Application of 50 μg/ml 6 or 9 times a day for 21 days resulted in complete resolution of clinical disease by day 21 while placebo treated animals continued to show symptoms for another 10 days. [0046] The results are depicted in FIG. 3 which shows CTC-96 treatment of Adenovirus induced keratoconjunctivitis. The data In FIG. 3 were obtained as follows: rabbits were infected with Human Adenovirus Type 5 by the installation 10 6 pfu adenovirus according to our protocol of conjunctival and corneal scarification for the production of Keratoconjunctivitis. On day 8 post-inoculation treatment with eye drops containing CTC-96 or placebo was initiated. Animals were examined for stromal keratitis and scored by the corneal disease scale of Wander et al.(5). The following are the Criteria For Determination Of Conjunctival Disease: Area of Conjunctival Disease Conjunctival Severity 0 Normal cornea. 0 Normal conjunctiva. +1 ≦25% involved. +1 Mild conjunctival injection. +2 >25%, ≦50% involved. +2 Moderate conjunctival injection/ chemosis. +3 >50%, ≦75% involved. +3 Severe conjunctival injection/ chemosis. +4 >75%, ≦100% involved. +4 Pseudomembrane present. [0047] The efficacy of CTC-96 treatment of rabbit eyes infected with Human adenovirus, Adenovirus type 5 (Ad5), was also evaluated by adenovirus recovery from tear film cultures adsorbed onto confluent HeLa cell monolayers. Application of 50 μg/ml 6 or 9 times a day resulted in a rapid fall in viral presence in the eye with no detectable virus by day 13 while placebo treated eyes continued to show detectable virus until day 24. FIG. 4 shows adenovirus titers after treatment of rabbit eyes with CTC-96 or placebo. These data were obtained by the following procedure: rabbits were infected with Human Adenovirus Type 5 by the installation 10 6 pfu adenovirus according to our protocol of conjunctival and corneal scarification for the production of Keratoconjunctivitis. On day 8 post-inoculation treatment with eye drops containing CTC-96 or placebo was initiated. Adenovirus recovery from tear film was evaluated by plaque assay on confluent HeLa cell monolayers. Data are presented as Average±SD.

1a

BACKGROUND OF THE INVENTION [0001] ‘Kiko’ is a product of a breeding-program which had the objective of creating new chrysanthemum cultivars with a decorative type flower, a 8 week response and a medium plant height (1 m.). The new plant of the present invention comprises a new and distinct cultivar of Chrysanthemum plant. ‘Kiko’ is a seedling from a cross in a breeding program maintained under the control of inventor. The female parent is #98.0106—unpatented—, an unnamed seedling not available to inventor for description. The male parent is unknown, being a mixed population of a group of male parents. The new and distinct cultivar was discovered and selected as a flowering plant within the progeny of the stated cross by Mark Roland Boeder in a controlled environment (greenhouse) in Rijsenhout Holland in 2001. The first act of asexual reproduction of ‘Kiko’ was accomplished when vegetative cuttings were taken from the initial selection in 2001 in a controlled environment in Rijsenhout Holland. SUMMARY OF THE INVENTION [0002] The present invention is a new and distinct variety of chrysanthemum bearing spectacularly large blooms with elongated quilled pink ray-florets. BRIEF DESCRIPTION OF THE DRAWINGS [0003] The present invention of a new and distinct variety of chrysanthemum is shown in the accompanying drawings, the color being as nearly true as possible with color photographs of this type. [0004] FIG. 1 shows a plant of the cultivar in full bloom. [0005] FIG. 2 shows the various stages of bloom of the new cultivar. [0006] FIG. 3 shows the foliage of the new cultivar. DESCRIPTION OF THE INVENTION [0007] This new variety of chrysanthemum is of the botanical classification Chrysanthemum morifolium. The observations and measurements were gathered from plants grown in Rijsenhout Holland in a photo-periodic controlled crop under conditions generally used in commercial practice. The greenhouse temperatures during this crop were at day-time between 18° C. and 25° C. and at night 20° C. After a long day period of 14 days the photo-periodic response time in this crop was 56 days. After the long day period to flowering growth retardants were applied 2 to 3 times in an average dose of 2.5 gram/liter water. The plants were observed (directly) during the flowering of this crop. When slightly damaged during harvest, the ray florets have proven to be sensitive to botrytis. No tests were done on disease or insect resistance or susceptibility. No tests were done on cold or drought tolerance. This new variety produces large sized inflorescences with elongated quilled pink ray-florets blooming on the plant for 5 weeks. This new variety of chrysanthemum has been found to retain its distinctive characteristics throughout successive propagations however the phenotype may vary significantly with variations in environment such as light intensity and temperature. To show the phenotype as described ‘Kiko’ can be planted without assimilation lightning (high pressure sodium lamps) between week 4 and week 32 under greenhouse conditions in Holland. With assimilation light (minimum level 2500 lux) it can be planted year round under greenhouse conditions in Holland. [0008] From the cultivars known to inventor the most similar existing cultivar in comparison to ‘Kiko’ is ‘Dance’ (U.S. Plant Pat. No. 12,941). When ‘Dance’ and ‘Kiko’ are being compared the following differences and similarities are noticed. Both ‘Dance’ and ‘Kiko’ are typically grown as disbud varieties, producing large sized blooms with elongated quilled ray florets. The differences of ‘Dance’ and ‘Kiko’ are (1) Size inflorescence. The size of the bloom of ‘Dance’ is smaller than that of ‘Kiko’ (2) Length ray floret. The ray florets of ‘Dance’ are shorter in length than those of ‘Kiko’. (3) Color ray florets. The ray florets of ‘Dance’ are purple colored, while those of ‘Kiko’ are pink. [0009] The following is a description of the plant and characteristics that distinguish ‘Kiko’ as a new and distinct variety. The color designations are taken from the plant itself. Accordingly, any discrepancies between the color designations and the colors depicted in the photographs are due to photographic tolerances. The color chart used in this description is: The Royal Horticultural Society Colour Chart, edition 1995. TABLE 1 Botanical Description of cultivar ‘Kiko’ Bud Size Large, cross-section 1.5 cm height 1.5 cm Outside color Yellow-green 145A Involucral bracts 3 rows, length 1 cm, width 1.5 cm Involucral bracts among disc-florets Not present Involucral bracts color Green 138B Inflorescences Type Double Height 5 cm Size Large Fully expanded 19 cm Number per stem 1 (typically grown as disbud) Performance on the plant 3 weeks Seeds Seed production not observed Fragrance Typical chrysanthemum, slight Peduncle length 3 cm Peduncle color Green 138C Color Center of the flower Immature Yellow-green 150D Mature Yellow-green 144D Color of the ray-florets Upper surface Red-purple 65B Lower surface Red-purple 65B Tonality from Distance A disbudded mum with pink flowers and a cream disc Color of the upper surface of the Red-purple 65B ray-florets after aging of the plant Ray florets Texture Upper and under side smooth Number 200 Shape Elongated quilled Longitudinal axis of majority Straight to incurving Length of corolla tube 8 cm Ray-floret margin Entire Ray-floret length 9 cm Ray-floret width 0.2 cm Ratio length/width High Shape of tip Incurved Disc florets Disc diameter 1 cm Distribution of disc florets Few, only visible at mature stages of flowering. Shape Tubular Color Yellow-green 154D Receptacle shape Domed raised Reproductive Organs Stamen Present in disc florets only Stamen color Yellow-green 144 B Pollen Produced in small quantities Pollen color Yellow 7A Styles Present in both ray and disc florets Style color Yellow 13A Style Length 4 mm Stigma color Yellow-green 145 D Stigma Width 1 mm Ovaries Enclosed in perianth Plant Form A disbudded mum meant for erect culture Growth habit Upright Growth rate Medium vigor Height 1 m Width 30 cm Internode lenght 2.5-3 cm Spray formation Not formed when grown as disbud Stem Color Yellow-green 148C Stem Strength Strong Stem Brittleness Not brittle Stem Anthocyanin coloration Absent Flowering Response (photo- 56 days periodic controlled crop, not natural season) Foliage Color immature stage Upper side Yellow-green 147B Under side Yellow-green 148C Color mature stage Upper side Yellow-green 147A Under side Yellow-green 148B Color midvein mature leaf Upper side Green 138C Under side Green 139C Size Large; length 15-17 cm, width 7-9 cm Quantity (number per single stem) 30 Shape Cordiform Texture upper side Fleshy and glabrous Texture under side Pubescent Venation arrangement Palmate Shape of the margin Dentate Shape of Base of Sinus Between Acute Lateral Lobes Margin of Sinus Between Lateral Converging Lobes Shape of Base Truncate Apex Mucronulate Petiole Length 1.5-3 cm Petiole Color Green 138C [0010] TABLE 2 Differences of ‘Kiko’ with comparison variety ‘Dance’ ‘Kiko’ ‘Dance’ Size inflorescence 19 cm 13.5 cm Length ray florets  9 cm   7 cm Color ray florets Red-purple 65B Purple 77B to 77C

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is related and claims priority to U.S. Provisional Patent Application No. 62/087,852 filed on Dec. 5, 2014. BACKGROUND [0002] During a flight or other travel methods such as car, trains, and the like, a passenger's hand cannot provide the support or the comfort needed to rest or comfortably relax. Using a pillow provided by the airline may be unsanitary and any pillow brought from home typically would be too large and/or inconvenient. The disclosed technology provides a solution for travelers struggling with the problem of comfortably resting one's head during road trips, times of relaxation, and travel. BRIEF DESCRIPTION OF THE DRAWINGS [0003] FIG. 1 is a top plan view of a pillow according to one example of the disclosed technology. [0004] FIG. 2 is a partial cut away view of the pillow shown in FIG. 1 in use. [0005] FIG. 3 is a partial cut away view of a pillow according to another example of the disclosed technology. [0006] FIG. 4 is a top plan view of the pillow shown in FIG. 3 . [0007] FIG. 5 is an end view of the pillow shown in FIG. 3 . [0008] FIG. 6 is a top plan view of still another example of a pillow according to the disclosed technology. [0009] FIG. 7 is an end view of a pillow according to another example of the disclosed technology. [0010] FIG. 8 is a top plan view of the pillow shown in FIG. 7 . [0011] FIG. 9 is a top plan view of a pillow according to another example of the disclosed technology. [0012] FIG. 10 is an end view of the pillow shown in FIG. 9 . [0013] FIG. 11 is a top plan view of a pillow according to an example of the disclosed technology. [0014] FIG. 12 is a top plan view of a pillow according to an example of the disclosed technology. DESCRIPTION [0015] For the purposes of promoting an understanding of the principles of the claimed technology and presenting its currently understood best mode of operation, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the claimed technology is thereby intended, with such alterations and further modifications in the illustrated device and such further applications of the principles of the claimed technology as illustrated therein being contemplated as would normally occur to one skilled in the art to which the claimed technology relates. [0016] The disclosed technology provides comfort for the hand, neck, and head when relaxing, sleeping, or traveling. The pillow may be made using nylon fiber as the fabric and thousands of micro-air beads to provide contoured support, cooling comfort airflow, and head, hand, and neck support. Variations of the pillow may use foam, down, feathers, and the like in place of the micro-air beads. Other variations may use other fabrics in place of nylon. The pillow itself may be fitted with the ambidextrous mitten-shaped sleeve and a removable pillow case. The pillows shown herein are generally square or round shaped and more or less symmetrical, but the present technology could also be practiced using pillows of other or more irregular shapes as desired. In some examples, the pillow and cover are machine washable and dryable. Sleeve sizes may vary so as to fit the hands of children, teenagers, and adults. Once the hand is in the desired position, users can then comfortably place their hand to their head and rest or sleep as desired. [0017] The disclosed technology comprises a variety of small and lightweight pillows that can easily be packed or stored away when not in use. FIG. 1 shows a top plan view of a hand pillow 10 according to one example of the disclosed technology. This particular example of a hand pillow 10 comprises a pillow or cushion portion 12 and a sleeve portion 14 . The pillow portion 12 comprises a fabric cover enclosing some type of padding or cushion. The fabric may be made of cotton, nylon, silk, denim, or any other suitable natural or synthetic material or combination thereof. The padding or cushion may be a plurality of micro-air beads, solid foam batting, feathers, or any other loose or solid suitable material normally used to fill pillows. [0018] The sleeve portion 14 is secured to one face of the pillow portion by a seam 16 . The seam 16 may be formed by stitching or secured using a suitable adhesive. Optionally the sleeve portion may be formed from the fabric cover of the pillow portion 12 itself. An opening 24 along one edge of the pillow 12 allows the user to insert a hand into the sleeve portion to hold the pillow 10 . Optionally, the opening 24 may include a draw string or other securing means so as to allow the user to tighten the opening 24 sufficiently so as to prevent the pillow 10 from sliding off the user's hand accidentally. The sleeve portion 14 in this particular example comprises two thumb portions 20 , 22 disposed on either side of a larger central cavity 18 . With this particular arrangement the user can insert either the left or right hand comfortably for use. In other examples, only a larger central cavity is used which still allows either hand to be used to hold the pillow but does not segregate the user's thumb from the rest of the hand. Optionally, the sleeve portion is lined with a material different from that which covers the rest of the pillow 10 such as fleece or other suitable material. [0019] FIG. 2 shows a pillow 10 according to the example shown in FIG. 1 in use. In this particular example, a user 28 has inserted his hand 26 into the sleeve portion 14 of the pillow 10 through the opening 24 . When the user curves his hand 26 into a loose fist the pillow portion 12 of the hand pillow 10 curves accordingly. The first face 32 of the pillow portion 12 on which sleeve 14 is disposed curves in towards the user's hand which allows the second face 30 of the pillow portion 12 which is disposed opposite the sleeve 13 to form a resting area for the user's face. [0020] FIGS. 3-5 show a partial cut away side view of another example of a hand pillow 34 according to the disclosed invention. In this particular example, the pillow 34 comprises a pillow portion 36 is generally shaped like a rectangular solid and has a first face 46 and a second face 38 on which a sleeve portion 48 is disposed. The sleeve portion 48 is generally rectangular in shape which allows a user 44 to insert either hand 42 into the sleeve through an opening 40 disposed along one end of the pillow portion 36 . The pillow portion 36 comprises an inner cushion portion and an outer covering portion which may be made from suitable materials as previously discussed. Optionally the pillow 34 may include an access opening 50 through which material may be added or removed from the pillow interior. The pillow portion 36 and sleeve 48 may be sized as desired with larger versions for adults and smaller versions for children. The hand pillow 34 may be used by inserting a hand 42 into the sleeve portion 48 and resting the first face 46 of the pillow portion 36 against the user's 44 face or head. In this particular example, the pillow portion 36 is sized so as to be at least slightly larger than the user's hand so that the entirety of the user's hand is covered by cushioning material when the pillow-covered hand is placed against the user's face or head. [0021] FIGS. 6-8 show yet another example of a hand pillow 52 according to the disclosed technology. In this example, the hand pillow 52 comprises a pillow portion 54 and a sleeve portion 56 which is sized and configured so as to allow insertion of their the user's right or left hand through an opening 58 near one edge of the pillow. The hand pillow further includes a strap portion 60 secured to one end either by stitching, glue, or some other suitable securing method. The strap 60 may be made from the same material as the pillow covering or of a different material. The user may insert a hand through the strap 60 prior to insertion into the sleeve portion so as to prevent the pillow from being lost or dropped. Optionally, the strap may be made from an elastic material so the pillow can be rolled up and the strap drawn over the outside of the roll to secure the pillow for storage as shown in FIGS. 7-8 . [0022] FIGS. 9-10 show yet another example of a pillow 62 according to the disclosed technology. In this particular example, the pillow 62 comprises a cushion portion 64 having a front face 78 and a back face 80 . A cavity 66 accessible via an opening 68 in one end of the cushion portion 64 is disposed between the front face 78 and back face 80 of the pillow and is generally sized and configured so as to accommodate either of the left of right hand of a user. A loop or strap comprising two separable portions 70 , 72 is fixed to the pillow. One end of each strap portions 70 , 72 is fixed to a face 78 , 80 of the pillow using glue, snaps, sewing, or other suitable means. Each strap portion 70 , 72 includes an end portion 74 , 76 where a releasable joining means is secured. The specific joining means may vary, but can include snaps, buttons, hook-and-loop style fasteners, and the like. The two strap portions 70 , 72 may be joined together at their respective end potions 74 , 76 to form a unified strap or loop. [0023] FIG. 11 shows another example of a hand pillow 90 according to the disclosed technology. In this example, a handle 94 is attached to one end of the pillow 90 . In this particular example, the handle 94 is attached to the end of the pillow opposite the opening 98 to the hand cavity 96 disposed within the cushion interior 92 of the pillow 90 . In other examples, the handle may be attached to one of the sides of the pillow adjacent to the opening 98 or on the same side as the opening 98 . [0024] FIG. 12 shows still another example of a hand pillow 100 according to the disclosed invention. In this example, a handle 104 is attached to one face 102 of the pillow 100 . The handle 104 is attached to the face 102 of the pillow approximately midway between the opening 108 to the hand cavity 106 disposed within the cushion interior of the pillow 100 and the opposite end of the pillow. In other examples, the handle may be attached to one of the faces of the pillow closer or farther from the opening to the pillow interior as desired. [0025] While the claimed technology has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. It is understood that the embodiments have been shown and described in the foregoing specification in satisfaction of the best mode and enablement requirements. It is understood that one of ordinary skill in the art could readily make a nigh-infinite number of insubstantial changes and modifications to the above-described embodiments and that it would be impractical to attempt to describe all such embodiment variations in the present specification. Accordingly, it is understood that all changes and modifications that come within the spirit of the claimed technology are desired to be protected.

1a

FIELD OF THE INVENTION The present invention relates generally to the field of glaucoma treatment and glaucoma devices, in particular to a new and useful implantable glaucoma shunt for relieving internal pressure in an animal's eye. More particularly, the present invention provides for a device and method for draining or diverting aqueous humor. Even more particularly, the invention provides for an apparatus and method of preventing postoperative hypotony. BACKGROUND OF THE INVENTION Glaucoma is a relatively common ocular disorder in animals. For example, glaucoma has long been recognized as a leading cause of human and canine blindness. The incidence of canine glaucoma, for example, is 0.5%. Increased incidence however is noted in specific breeds. Despite its importance, the long-term control of canine primary glaucoma, whether medical or surgical, continues to elude the veterinary profession. The current state of the art for long term control of glaucoma in humans and/or dogs and/or other animals (hereinafter, for convenience, sometimes collectively referred to as “animals”) includes medical management, cyclophotocoagulation and anterior chamber shunts. For example, anterior chamber implants are used to drain or divert fluids, such as aqueous humor. One of the disadvantages of the art is that implants in dogs fail to maintain normotensive intraocular pressures for more than 6 months postoperatively or do so only when combined with other forms of glaucoma therapy including medical and surgical management. Some implantable glaucoma shunts are simply cylinders that are inserted nearly perpendicularly into the animal's eye and are held by frictional fit by eye tissue. In other words, one of the problems with the art is that the implantable shunts do not remain secure to the site for the purpose of draining or diverting aqueous humor extraocularly. Furthermore, postoperative hypotony occurs when aqueous humor production does not keep pace with outflow. Thus, it is imperative that outflow of aqueous humor be regulated. Other methods of draining or diverting aqueous humor in dogs have focused on varying implants from valved to nonvalved, and altering explant sites from sclera, subcutaneous, or microvascular, to achieve a route for aqueous drainage. Studies in humans and dogs indicate that the failure of standard drainage procedures arises mainly due to fibrosis at the site of the filtration bleb and reduced absorptive area for aqueous humor from the scarring, or tube occlusion. Cytokines including fibroblastic growth factor and transforming growth factors β1 and β2 have been demonstrated in the aqueous humor of dogs and humans with chronic ocular disease including primary glaucoma. These agents have marked mitogenic activity for mesenchymal cells which are responsible for occlusion of these filtering sites. Blocking the effects of these fibroblast stimulating cytokines may inhibit scarring and prevent failure of these filtering procedures. Numerous drugs including mitomycin-C, an antineoplastic, antibiotic agent that reduces collagen production by fibroblasts, have been used to help prevent implant obstruction. Mitomycin-C has yielded some benefit in the success rates of filtration surgeries in humans, monkeys, and rabbits, and has been noted to suppress but not prevent fibrosis around anterior chamber silicone implants in clinically normal dogs. Many inflammatory diseases are associated with excessive or inappropriate cytokine activity. Cytokines activate lymphocytes and macrophages resulting in a markedly increased production of proteolytic enzymes which rather contribute to the inflammatory process and fibrosis. Intravascular shunting of cytokine-laden aqueous humor may suppress processes and prevent implant fibrosis. Unfortunately implant obstructions, caused by blood reflux, occurred both intraocularly and at the intravascular implant junction. These failures in conjunction with the inability of antineoplastics to prevent fibrosis around implants in dogs attest to the need of shunting aqueous humor to an epithelium-lined site with minimal exposure of mesenchymal tissue. The frontal sinus is an accessible epithelium-lined space and is a potential site for long-term extraorbital diversion of aqueous humor. Consequently, a need exists in the art for a device and a method for the treatment of glaucoma in animals. A need also exists in the art for draining or diverting aqueous humor extraocularly. In contrast to the prior art, the present invention provides for a shunt to drain or divert fluids, such as aqueous humor, extraocularly, from the anterior chamber to the frontal sinus via a valve with consistent opening and closing pressures, and to improve frontal sinus implantation and retention via an anchoring bulb and plug stopper. OBJECTS OF THE INVENTION Therefore, it is an object of the invention to provide a device and method for treating animals with primary glaucoma. It is a further objective of the invention to provide a device and method for preventing postoperative hypotony in animals. It is still another objective of the invention to provide a device and method for the diverting or draining aqueous humor extraocularly, from the anterior chamber to the frontal sinus cavity in animals. It is still another objective of the invention to provide an implantable shunt that retains its position in the frontal sinus cavity and drains or diverts the aqueous humor extraocularly. It is still another objective of the invention to provide an implantable shunt that controls the flow of aqueous humor flow at a required volume. It is still another objective of the invention to provide an implantable shunt that has a bulb wherein when the shunt is tugged back slightly during implantation, the bulb holds the device in position. It is still another objective of the invention to provide an implantable shunt having a length and tubing to ensure fluid flow from the animal's eye directly into the frontal sinus cavity. It is a specific object of the invention to provide an aqueous humor shunt device to divert or drain aqueous humor in an animal's eye from the anterior chamber into the frontal sinus cavity, the shunt device comprising a tubing; a crossbeam affixed to the tubing; a bulb molded to the tubing; and at least one slit valve to control fluid flow at a required volume; wherein the length and tubing of the shunt ensure fluid flow from the eye directly into the frontal sinus cavity. Various other objects, advantages and features of the present invention will become readily apparent from the ensuing detailed description. SUMMARY OF THE INVENTION Accordingly, a new device for treating glaucoma is provided comprising implanting a shunt from the anterior chamber to the frontal sinus via a hollow tube. The device is used to divert or drain aqueous humor from the anterior chamber of an animal's eye to help decrease intraocular pressure and thereby control glaucoma. According to one aspect of the present invention, a shunt device is provided for diverting or draining fluid from an animal's eye from the anterior chamber into the frontal sinus cavity, the shunt device comprising a tubing; a crossbeam affixed to the tubing; a bulb affixed to said tubing; and at least one slit valve, wherein the tubing's length conducts the aqueous humor fluid flow from the anterior chamber of an animal's eye into the frontal sinus cavity. According to another aspect of the present invention, a method for treating primary glaucoma in an animal comprising implanting in an animal's eye in need thereof an anterior chamber shunt, said shunt comprising: a tubing; a crossbeam affixed to the tubing; a bulb; and a slit valve, wherein the tubing's length ensures aqueous humor fluid flow from the anterior chamber of an animal's eye directly into the frontal sinus cavity. According to a further aspect of the present invention, a method is provided for preventing postoperative hypotony comprising implanting in an animal's eye in need thereof a shunt, said shunt comprising a tubing; a crossbeam affixed to the tubing; a bulb; and a slit valve, wherein the tubing's length allow for aqueous humor fluid flow from the anterior chamber of an animal's eye directly into the frontal sinus cavity. The device is an implantable shunt for diverting or draining aqueous humor from the anterior chamber of an animal's eye to the frontal sinus via tubing, having a guide needle at one end thereof, for flushing the shunt preoperatively to ensure slit-valve function and a plug tip at an opposite end of the tubing. The guide needle is removable from the tubing and does not remain in the frontal sinus. Slits are formed at 90° on the tubing adjacent to the plug tip forming a conduit for draining fluid from the anterior chamber of the eye into the frontal sinus. The slits are provided as one-way flow resisting valves in the tubing for allowing a flow of fluid to pass under resistance and in only one direction from the anterior chamber to the frontal sinus, whereby pressure in the anterior chamber is relieved while avoiding excessive outflow of aqueous humor from the anterior chamber. The shape of the device allows easy insertion. Crossbeam aids are affixed to the tubing for anchoring the device to the outside (periosteum) of the frontal sinus. A bulb is molded to the tubing to anchor the shunt in the frontal sinus. When the shunt is tugged back slightly during the surgical procedure, the bulb holds the device in position. The length and the diameter of the tubing ensure fluid flow form the eye directly into the frontal sinus cavity. These and other embodiments of the invention are provided in or are obvious from the following detailed description of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The following detailed description given by way of example, but not intended to limit the invention solely to the specific embodiments described, may best be understood in conjunction with the accompanying drawings in which: FIG. 1 is a top view of the shunt of the present invention. FIG. 2 is a side view of the present invention. FIG. 3 is a top view of the present invention. FIG. 4 is the perspective view of A—A on FIG. 3 . DETAILED DESCRIPTION The present invention provides an a method for treating primary glaucoma and an anterior chamber shunt device to drain or divert aqueous humor in an animal's eye from the anterior chamber into the frontal sinus cavity, in which the shunt device comprises a first end, adapted to be fitted with a guide needle, to be received within the anterior chamber following removal of the guide needle, and a second end having a crossbeam, bulb, slits and a plug tip to be received within the frontal sinus cavity, wherein the device permits aqueous humor communication from the anterior chamber to the frontal sinus cavity through the slit valves. Fluid communication can be facilitated by intraocular pressure directing the aqueous humor into the slits, as described below. The embodiments of the present invention can be used to treat animals with primary glaucoma, particularly to drain or divert aqueous humor extraocularly and, more particularly to prevent postoperative hypotony. Referring now to the drawings, in which like reference numerals are used to refer to the same or similar elements, FIG. 1 shows the glaucoma shunt device ( 110 ) of the invention having tubing ( 120 ), and a guide needle ( 130 ) at a first end thereof, for communicating with the anterior chamber, and a plug tip ( 140 ) at an opposite end of the tubing. Guide needle ( 130 ) is removed from tubing ( 120 ) and does not remain in the sinus. Bulb ( 150 ) is connected to tubing ( 120 ) and anchors shunt ( 110 ) within the frontal sinus cavity. Guide needle ( 130 ) does not remain in the sinus. Slits ( 160 ) at 90° from bulb ( 150 ) to the plug tip ( 140 ) form a conduit for draining fluid from the anterior chamber of the eye. Slits ( 160 ) are provided as one-way flow resisting valves in the tubing for allowing a flow of fluid to pass under resistance and in only one direction to the frontal sinus, whereby pressure in the anterior chamber is relieved while avoiding excessive outflow of fluid from the anterior chamber. Crossbeam elements ( 170 ) are affixed to tubing ( 120 ) for anchoring the device to the outside (periosteum) of the frontal sinus. Higher pressure aqueous humor inside the animal's eye can naturally drain through glaucoma shunt device ( 110 ) via slits ( 160 ), and tubing ( 120 ) to the frontal sinus cavity. Thus, intraocular pressure is relieved. FIG. 2 is a side view of the device. Guide needle ( 130 ) can be any conventional guide needle, for example, a 20 or 22 gauge precision guide needle available from Becton Dickinson. The guide needle is friction fitted to tubing ( 120 ) and is removable therefrom. The overall length of tube ( 120 ) is approximately 60 millimeters, with the proviso that length and tubing of the shunt ensure fluid flow from the eye directly into the frontal sinus cavity. Tubing ( 120 ) has an inside diameter of approximately 0.64 millimeters and an outside diameter of approximately 1.2 millimeters. The outer and inner walls form a tubular channel to allow fluid flow from the eye into the frontal sinus cavity. Phantom lines on FIG. 2 display the tubular channel within the device. In all cases the length and the diameter of the tubing ( 120 ) must ensure fluid flow from the eye directly into the frontal sinus cavity. Tubing ( 120 ) is made of any suitable material known in the art, such as, for example, medical grade radiopaque silicone rubber, and is flexible. At the opposite end of the device is a plug tip ( 140 ). The plug tip is made of any suitable material known in the art, such as, for example, silicone. Bulb ( 150 ) is approximately 3 millimeters from plug tip ( 140 ). Bulb ( 150 ) is made of any suitable material known in the art, such as, for example, clear silicone. Bulb ( 150 ) provides an anchoring aspect to the shunt. Bulb ( 150 ) is molded onto tube ( 140 ). Bulb ( 150 ) has a rounded portion ( 151 ) and an angled portion ( 152 ). Angled portion ( 152 ) forms a straight line at approximately 52° from a line perpendicular to tube ( 120 ) and rounded portion ( 151 ) has a diameter of approximately 4 mm. The maximum length of bulb ( 150 ) is 4 millimeters measured through the tubing. Slits ( 160 ) are formed in the tubing between the end of angled portion ( 152 ) of bulb ( 150 ) to plug tip ( 140 ). Slits ( 160 ) are at 90° degrees on the tubing and are approximately 3 millimeters in length. Slits ( 160 ) form a conduit for draining fluid from the anterior chamber of the eye into the frontal sinus cavity. Slits ( 160 ) provide one-way flow resisting valves in the tubing for allowing a flow of fluid to pass under resistance and in only one direction to the frontal sinus, whereby pressure in the anterior chamber is relieved while avoiding excessive outflow of fluid from the anterior chamber. The slits ( 160 ) drain the fluid in the anterior eye at an opening pressure between 18–20 mmHg. The slits ( 160 ) arc closed at pressures under 18 mmHg. Thus, the outflow of aqueous humor is regulated at consistent opening and closing pressures and the volume of aqueous humor is controlled. The slits ( 160 ) may be adjusted to be open at a different pressure. Furthermore, the consistent opening and closing pressures prevent postoperative hypotony because the level of volume of aqueous humor is regulated. Any conventional means may be used to test and make the slits ( 160 ) in the tubing. FIG. 3 is a top view of the device with labeled section A—A. Crossbeams ( 170 ) with crossbeam ends ( 181 ) are provided. The materials used to make crossbeams ( 170 ) is made of any suitable material known in the art, such as, for example fluorocarbon suture material. The crossbeams are glued with silicone cement to the tubing approximately 11 millimeters from the plug tip ( 140 ) end of the device. However, a skilled artisan would readily understand that there are other ways to secure the crossbeams to the tubing. Crossbeams ( 170 ) form a diameter of approximately 11 millimeters measured through the tubing. Crossbeams ( 170 ) help to position device ( 110 ) by providing aids for anchoring the device to the outside surface (periosteum) of the frontal sinus. Crossbeams ends ( 181 ) further define adhesives to aid in the anchoring. The materials used to make the adhesives are made of any suitable material known in the art, such as, for example medical grade silicone adhesive. The shape of shunt ( 110 ) allows easy insertion into the anterior chamber and the frontal sinus cavity and when the shunt is tugged back slightly during suturing the anterior chamber end, the crossbeams ( 170 ) and bulb ( 150 ) hold device ( 110 ) in position. FIG. 4 is the perspective view of A—A of FIG. 3 . The crossbeams further define left arm ( 182 ) and right arm ( 183 ). The left and right arms may be any shape and thickness that aids in suturing the device, but preferably are 0.28 millimeters thick. The arms are affixed to the tube approximately 0.152 millimeters from the inner wall of the tubular channel. Although preferred embodiments of the present invention and modifications thereof have been described in detail herein, it is to be understood that this invention is not limited to those precise embodiments and modifications, and that other modifications and variations may be affected by one skilled in the art without departing from the spirit and scope of the invention as defined by the appended claims.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of Invention [0002] The present invention relates to the field of clasps used for securing jewelry on the wearer. [0003] 2. Description of Prior Art [0004] Jewelry clasps known in the prior art are subject to several limitations. For instance, conventional jewelry clasps are difficult to engage and disengage, as the clasp is capable of being secured by the wearer in only one direction. Accordingly, the wearer must carefully engage and secure the clasp. Additionally, a jewelry clasp securable in only one direction requires additional time and effort of the wearer to properly open and close likewise, the projections on such clasps are prone to snagging the wearer's hair and/or clothes. [0005] U.S. Pat. No. 4,924,562 to Pogharian (“Pogharian”) is an example of the prior art which exhibits such limitations. The latch member of Pogharian can only be inserted and secured into the housing in one direction. Additionally, the latch member of Pogharian contains an external stop member formed to abut the outer end of the housing bottom in order to firmly secure the clasp. This additional structure, projecting externally from the housing, can catch and snag on the wearer's hair and/or clothing during the clasp's engagement. [0006] In view of the foregoing, there is a need for a jewelry clasp that overcomes the deficiencies of the prior art. SUMMARY OF THE INVENTION [0007] The present invention provides for a jewelry clasp which is engagable in multiple directions, reliable, sturdy, and secure. The present invention includes a jewelry clasp of the latch type having a pivotally mounted catch member in a housing and spring actuated in conjunction with a latch member which is insertable and engagable in multiple directions. [0008] According to one embodiment of the present invention, the housing is grooved on both parallel walls near the end in which the latch member is inserted. The latch member includes a raised circular notch on one side which fits into the groove in the housing, insertable into the housing up to the point where the raised circular notch abuts the end of the groove. In an alternative embodiment, the latch member includes raised circular notches stationed in the same relative positions on each side. [0009] Accordingly, it is the object of the present invention to provide a jewelry clasp that is engagable in multiple directions, which is secure and easily opened and closed by the wearer. [0010] It is a further object of the present invention to provide a jewelry clasp that is free from external parts which can catch and snag the wearer's hair and/or clothing. Other objects of the present invention shall be apparent to a person skilled in the art based on the disclosure contained herein. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate by way of example and not limitation, the present invention, and together with the preceding general description and the following detailed description, explain the principles of the invention. [0012] In the drawings: [0013] [0013]FIG. 1 is a perspective view of an embodiment of the present invention in an engaged condition. [0014] [0014]FIG. 2 is a sectional view taken on line 2 - 2 of FIG. 1. [0015] [0015]FIG. 3 is a sectional view taken on line 3 - 3 of FIG. 2. [0016] [0016]FIG. 4 is a sectional view taken on line 4 - 4 of FIG. 2. [0017] [0017]FIG. 5 is a sectional view similar to FIG. 2, but showing the elements of the invention in the disengaged condition. [0018] [0018]FIG. 6 is a sectional view similar to FIG. 5, illustrating the unlocking of an embodiment of the present invention. FIG. 6 additionally illustrates that rotating the latch member 180° will not impact engagement or disengagement. [0019] [0019]FIG. 7 is a top view of an alternative embodiment of the latch member. DETAILED DESCRIPTION OF THE INVENTION [0020] Embodiments of a jewelry clasp which utilize the present invention address the need for an apparatus that is reliable, sturdy, secure and capable of engagement in multiple directions. Ideally, the present invention allows for the quicker and easier engagement and disengagement of the wearer's jewelry, along with the lack of the jewelry clasp containing an external structure which can catch and snag in the wearer's hair or clothing. As is shown in the Figures, a jewelry clasp ( 1 ) capable of engagement in multiple directions is described. The jewelry clasp ( 1 ) may be constructed of any metallic material of strength and economic feasibility such as gold alloy, sterling silver, stainless steel, or the like. [0021] In a first embodiment of the present invention, the jewelry clasp ( 1 ) includes a channel housing ( 10 ) with two opposed and parallel side walls ( 20 ) and ( 22 ) and a bottom ( 30 ). Side walls ( 20 ) and ( 22 ) extend to form into rings ( 28 a - b ) to receive the necklace or chain. The outer end of the housing ( 10 ) is open to receive a latch member ( 40 ). The housing ( 10 ) includes two opposed grooves ( 5 a ) and ( 5 b ) on each of the side walls ( 20 ) and ( 22 ), respectively. To increase reliability and minimize the amount of pieces required for assembly, the housing ( 10 ) and its side walls ( 20 ) and ( 22 ), bottom ( 30 ), and rings ( 28 a - b ) may be constructed as one piece of material and shaped to conform to the embodiment of the present invention. [0022] In an embodiment of the present invention, the latch member ( 40 ) is arrow-shaped with its outer end formed into a ring ( 28 c ) to receive the necklace or chain. The latch member ( 40 ) includes two side panels ( 42 ) and ( 44 ). A circular notch ( 100 ) is provided on the first side panel ( 42 ) of latch member ( 40 ). The circular notch ( 100 ) is of a size to fit within grooves ( 5 a ) and ( 5 b ). An arrow-shaped insertion member ( 46 ), including indentations ( 48 a ) and ( 48 b ) formed therein, is provided on one end of latch member ( 40 ). The indentations ( 48 a ) and ( 48 b ) receive the hook portion ( 52 ) of a catch member ( 50 ). The inner end of the insertion member ( 46 ) is preferably rounded to a point and abuts the stop portion ( 54 ) of the catch member ( 50 ). [0023] In an alternative embodiment of the present invention, the side panels ( 42 ) and ( 44 ) each contain a circular notch ( 100 ) and ( 101 ), the center lines of such notches being co-linear. See FIG. 7. [0024] Catch member ( 50 ) is pivotally mounted by a pin ( 60 ) inside housing ( 10 ) and has a downward tail ( 56 ) preferably approximately half the length of housing ( 10 ). A spring ( 70 ) is held in place between protrusions ( 59 a ) and ( 59 b ). One end of the spring ( 70 ) rests on the interior of the bottom ( 30 ) of the housing ( 10 ). So configured, the spring ( 70 ) acts as a bias member on the catch member ( 50 ). [0025] Housing ( 10 ) contains a recess ( 16 ) wherein the indentation ( 58 ) of catch member ( 50 ) protrudes to a level equal with the housing ( 10 ). Indentation ( 58 ) is of a size capable of accepting a person's fingernail or other device for pressing down the catch member ( 50 ) and for compression of the spring ( 70 ). [0026] To engage, the wearer inserts latch member ( 40 ) into the open end of housing ( 10 ). The insertion member ( 46 ) pushes against hook portion ( 52 ) of the catch member ( 50 ). This action causes the spring ( 70 ) to compress, allowing the insertion member ( 46 ) to be inserted into the housing ( 10 ) until it abuts the stop portion ( 54 ) of the catch member ( 50 ). Circular notch ( 100 ) fits within grooves ( 5 a ) or ( 5 b ), resting securely at the end of grooves ( 5 a ) or ( 5 b ) when insertion member ( 46 ) abuts stop portion ( 54 ). The spring ( 70 ) recoils and the catch member ( 50 ) recedes back into housing ( 10 ), with indentation ( 48 a ) or ( 48 b ) being locked into place by hook portion ( 52 ). Due to the jewelry clasp's ability to engage in multiple directions, only one of grooves ( 5 a ) and ( 5 b ) and indentations ( 48 a ) and ( 48 b ) is necessary to secure the engagement of the latch member ( 40 ). Thus, a complete 180° rotation of the latch member ( 40 ) will not affect engagement, allowing the wearer to engage the clasp ( 1 ) in multiple directions. See FIGS. 5 - 6 . [0027] To disengage, the wearer applies downward pressure on indentation ( 58 ), thereby compressing the bias member and pivoting the catch member ( 50 ) up so that hook portion ( 52 ) separates from indentation ( 48 a ) or ( 48 b ), allowing latch member ( 40 ) to freely slide out of the housing ( 10 ). [0028] Thus, a jewelry clasp for securing jewelry is disclosed. Although the present invention has been described with reference to specific exemplary embodiments, it will be evident to those skilled in the art that various changes and modifications may be made to these embodiments, and equivalents may be substituted for elements in these embodiments, without departing from the general spirit and scope of the invention as set forth in the claims. Accordingly, the specification and drawings should be regarded in an illustrative rather than a restrictive sense.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional application of and claims priority to U.S. application Ser. No. 13/450,563, filed Apr. 19, 2012, which application is a divisional application of and claims priority to U.S. application Ser. No. 11/055,572, filed on Feb. 10, 2005, now U.S. Pat. No. 8,185,199. These applications are hereby incorporated by reference. TECHNICAL FIELD [0002] This invention relates to monitoring physiological signals (e.g., ECG signals) on the exterior of a patient during external electrical stimulation (e.g., pacing) of the patient. BACKGROUND [0003] It is often desirable to monitor physiological signals during or after delivery of electrical stimulation to a patient. For example, ECG signals are typically monitored during external cardiac pacing. But the electrical stimulation can produce stimulus artifacts in the monitored signal. To reduce the magnitude of such artifacts, monitoring electrodes are often intentionally placed at a considerable distance from stimulation electrodes. The stimulus artifact is attenuated by distance through the body and has less effect on the measured physiological signals of interest. For example, standard ECG lead placement for monitoring a patient during external cardiac pacing is shown in FIG. 1 . Two ECG leads are placed high on the chest near each arm, and a third low on the chest near one leg, all at a considerable distance from the stimulation electrodes. To achieve this distant placement of the monitoring electrodes, the caregiver must typically place five separate electrodes on the patient, and connect separate monitoring cables to each of the ECG electrodes (typically, the stimulation electrodes have cables pre-connected). [0004] An alternative to separate, remotely positioned monitoring electrodes is using the stimulation electrodes for both stimulation and monitoring. Monitoring could, in theory, be done during intervals between stimulation pulses, but a large stimulus artifact is typically present for much of that interval, and thus it has not typically been practical to use the stimulation electrodes for ECG monitoring during pacing. For example, the ECG signal induced by the pacing pulse often occurs within 200 milliseconds subsequent to the pacing pulse and before the artifact has sufficiently attenuated to allow for adequate monitoring. [0005] The stimulus artifact during pacing can make the ECG difficult to interpret, even when the ECG is detected on remotely positioned monitoring electrodes. It is generally required that the ECG be clean enough so that the effectiveness of pacing can be assessed and the stimulus energy adjusted as needed. The stimulus artifact is often so large as to make that assessment difficult or impossible. [0006] Internal pacing involves much lower currents applied directly to the heart and monitoring through the stimulation electrodes has been accomplished in the prior art. The problem of stimulus artifacts in the ECG signal principally arises with external pacing where the higher currents and larger therapy electrodes require the use of separate monitoring electrodes located at a sufficient distance. A similar problem exists during external cardiac defibrillation, but there is less need to detect an ECG signal within milliseconds after the stimulus as is the case with pacing. [0007] Electrical stimulation requires the delivery of an electrical current to the body. Current flows from one stimulation electrode to the other, and often results in the stimulation electrodes becoming polarized following delivery of a stimulation pulse (opposite polarity charge buildup on the two electrodes). A stimulus artifact is seen on the monitoring electrodes both during and after the stimulation pulse, with the amplitude of the artifact typically depending on the position of the monitoring electrode in the electric field created by the difference in potential on the two stimulation electrodes. [0008] Physiological monitoring systems typically amplify the potential difference(s) between monitoring electrodes. The signals of interest are often much smaller in magnitude than the stimulus artifact. Thus, the artifact often masks the physiological signals or saturates the circuitry used for monitoring. Certain applications require acquisition of physiological waveforms during or immediately after the stimulus (e.g., cardiac pacing), and the presence of the stimulus artifact is problematic. [0009] Some efforts have been undertaken to mitigate the effect of the stimulus artifact on the physiological monitoring. Way U.S. Pat. Nos. 4,955,381 and 5,080,099 proposed an electrode assembly in which a separate monitoring electrode was spaced a short distance from the stimulus electrode in a single assembly. Dupelle et al. U.S. application Ser. No. 10/958,987, filed on Oct. 5, 2004 teaches providing a depolarizing current following a stimulus to reduce the polarization artifact. Hauck et al. U.S. Pat. No. 5,330,512 taught a solution for implanted electrodes wherein the stimulus is much lower than for external electrodes, and the implanted leads have a much smaller surface area than pads of external electrodes. SUMMARY [0010] We have discovered that in external pacing the effect of the stimulus artifact on physiological monitoring can be reduced if a plurality of external monitoring electrodes across which a potential is measured are configured so that the artifact is substantially cancelled out in a signal formed from the electrical potentials detected at the two monitoring electrodes. [0011] In a first aspect, the invention features a device-implemented method of monitoring and stimulating the exterior of the human body with electrodes, comprising delivering stimulation pulses to stimulation electrodes applied to the exterior of the body, detecting an electrical potential at monitoring electrodes applied to the exterior of the body, positioning at least a first and second monitoring electrode at locations at which an electrical artifact caused by the electrical stimulation pulses is substantially cancelled in a signal formed from the electrical potentials detected at the first and second monitoring electrodes. [0012] Preferred implementations of this aspect of the invention may incorporate one or more of the following. The signal formed from the electrical potentials may comprise a difference signal that comprises a difference between the electrical potentials detected at the first and second monitoring electrodes. The first and second monitoring electrodes may be at locations at which the electrical artifact is substantially equal. The stimulation pulses may comprise cardiac stimulation pulses, and the difference signal may comprise an ECG signal. The cardiac stimulation pulses may comprise pacing pulses. There may be at least three monitoring electrodes applied to the exterior of the patient, and the first and second monitoring electrodes may be selected from among the at least three monitoring electrodes, with the selection being made so as to reduce the effect of the electrical artifact on the difference signal. The selection of first and second monitoring electrodes may be made automatically by the device rather than manually by the user. The automatic selection of the first and second monitoring electrodes may vary over time. The at least three monitoring electrodes may comprise at least two monitoring electrodes positioned at different distances from one of the stimulation electrodes, and wherein the selection of the first monitoring electrode may comprise choosing between the two electrodes positioned at different distances. The choosing between the two electrodes may vary over time. The invention may further comprise at least a third monitoring electrode applied to the exterior of the patient, and wherein the difference signal may comprise the difference between the electrical potential detected at the first electrode and a combination of the electrical potential detected at the second and third electrodes. The manner in which the combination is made may vary over time to compensate for variation over time of the relative magnitude of the electrical artifact at the second and third electrodes. The invention may also further comprise at least a fourth monitoring electrode applied to the exterior of the patient, and wherein the difference signal may comprise the difference between a combination of the electrical potential detected at the first and fourth electrodes and a combination of the electrical potential detected at the second and third electrodes. One or both of the combination of the electrical potential detected at the first and fourth electrodes and a combination of the electrical potential detected at the second and third electrodes may vary over time. The edge-to-edge separation between the active areas of the at least first and second monitoring electrodes and the active area of one of the stimulation electrodes may be less than 10 centimeters. The at least first and second monitoring electrodes may be positioned at the same separation from one of the stimulation electrodes. The invention may further comprise a third monitoring electrode positioned at the same separation as the first and second electrodes from one of the separation electrodes. The first and second monitoring electrodes and the one stimulation electrode may be fixed in position on a common substrate. The at least first and second monitoring electrodes may be positioned so that they are at approximately the same electrical potential in an electric field formed between the two stimulation electrodes when the stimulation electrodes are polarized following a stimulation pulse. The at least first and second monitoring electrodes may be positioned along approximately the same field line in an electric field formed between the two stimulation electrodes when the stimulation electrodes are polarized following a stimulation pulse. The first and second monitoring electrodes may be supported on a first substrate that is separate from a second substrate supporting one of the stimulation electrodes. The first substrate supporting the first and second monitoring electrodes may substantially surround the second substrate. The first substrate may be annular in shape and the second substrate may be circular in shape, and the two substrates may be positioned approximately concentrically, so that the separation between the two may be approximately an equal radial distance. The at least first and second monitoring electrodes and the at least one stimulation electrode may form one assembly. The positions of the at least first and second monitoring electrodes and the stimulation electrode may be fixed on the assembly, so that the separation between each of the monitoring electrodes and the stimulation electrode may be fixed. Electrical artifact potential in the ECG difference signal may be less than about 10 millivolts measured within 100 milliseconds after termination of the cardiac pacing pulse. The electrical artifact potential in the ECG difference signal may be less than five times the QRS amplitude when the pacing pulses are of sufficient amplitude to capture the heart. Detecting an electrical potential at monitoring electrodes may comprise an impedance matching circuit to which at least the first and second monitoring electrodes may be connected. The impedance matching circuit may create an imbalance in the electrode impedances to compensate for variation in the electrical artifact potential in the two monitoring electrodes. There may be a plurality of difference signals, and the difference signals may be used in a transformation to derive ECG signals that resemble standard 3-lead ECG signals. [0013] The invention may also further comprise having a monitoring device automatically identify a nonstandard monitoring configuration from one or more of the electrodes or from a connector used to the connect the electrodes to the monitoring device, and in the event of identifying the nonstandard monitoring configuration automatically modifying signal processing of the detected electrical potentials. The invention may further comprise positioning a third electrode on the body, and wherein the signal formed from the electrical potentials may comprise a summation of electrical potentials measured at the first and second electrodes with respect to the third electrode, and wherein the electrical artifact may be substantially cancelled in the signal as a result of the electrical artifact being of similar magnitude but of opposite polarity in the electrical potentials measured. There may be at least first and second stimulation electrodes, and the first monitoring electrode may be positioned in the vicinity of the first stimulation electrode, and the second monitoring electrode may be positioned in the vicinity of the second stimulation electrode. The signal may be formed in a manner that is varied over time. The signal may be formed by forming a combination of the electrical potentials at the first end and second monitoring electrodes, and the manner in which the combination is made may be varied over time. [0014] In a second aspect, the invention features a method of external monitoring and external stimulating the heart, comprising delivering stimulation pulses between a first polarity stimulation electrode and a second polarity stimulation electrode applied to the exterior of the body, wherein at least the first polarity stimulation electrode comprises a plurality of smaller electrodes, through which the stimulation pulses are applied, wherein the aggregate area of the smaller electrodes is sufficient for stimulation; and monitoring an ECG potential by forming a difference signal that comprises the difference between the electrical potentials detected at two of the smaller electrodes, wherein the two smaller electrodes used to form the difference signal are positioned and configured so that the stimulus artifact from polarization is approximately equal on both of the smaller electrodes, so that the stimulus artifact is approximately cancelled in the difference signal. [0015] Preferred implementations of this aspect of the invention may incorporate one or more of the following. The stimulation pulses may comprise cardiac pacing pulses applied to the exterior of the chest. [0016] In a third aspect, the invention features an electrode assembly for external cardiac pacing and external cardiac monitoring, comprising at least one external stimulation electrode for delivering a pacing pulse, at least first and second external monitoring electrodes, at least one positioning element to which the stimulation and first and second monitoring electrodes are connected, wherein the positioning element, stimulation electrode, and first and second monitoring electrodes are configured so that the first and second monitoring electrodes are located in positions in which an electrical artifact caused by the pacing pulses is substantially cancelled in a difference signal formed by taking a difference between the electrical potentials detected at the first and second monitoring electrodes. [0017] Preferred implementations of this aspect of the invention may incorporate one or more of the following. The positioning element may comprise a common substrate that supports the stimulation electrode and the first and second monitoring. The positioning element may comprise elements such as wires that prescribe the separation of the first and second monitoring electrodes from the stimulation electrode. The edge-to-edge separation between the active areas of the at least first and second monitoring electrodes and the active area of one of the stimulation electrodes may be less than 10 centimeters. The at least first and second monitoring electrodes may be positioned at the same separation from one of the stimulation electrodes. The invention further comprises a third monitoring electrode positioned at the same separation as the first and second electrodes from one of the separation electrodes. The at least first and second monitoring electrodes may be positioned so that they are at approximately the same electrical potential in an electric field formed between the two stimulation electrodes when the stimulation electrodes are polarized following a stimulation pulse. The at least first and second monitoring electrodes may be positioned along approximately the same field line in an electric field formed between the two stimulation electrodes when the stimulation electrodes are polarized following a stimulation pulse. The first and second monitoring electrodes may be supported on a first substrate that is separate from a second substrate supporting one of the stimulation electrodes, and the first and second substrates may be shaped to facilitate their being applied to the patient in a desired relative position. The first substrate may be annular in shape and the second substrate may be circular in shape, and the two substrates may be positioned approximately concentrically, so that the separation between the two may be approximately an equal radial distance. The first and second monitoring electrodes and the stimulation electrode may form one assembly. The positions of the at least first and second monitoring electrodes and the stimulation electrode may be fixed on the assembly, so that the separation between each of the monitoring electrodes and the stimulation electrode may be fixed. [0018] In a fourth aspect, the invention features an electrode assembly for external cardiac pacing and external cardiac monitoring, comprising at least one external stimulation electrode for delivering a pacing pulse, the stimulation electrode comprising a stimulation conductive plate, at least one external monitoring electrode, the monitoring electrode comprising a monitoring conductive plate, a backing layer supporting the stimulation and monitoring electrodes, wherein the stimulation conductive plate and monitoring conductive plate are spaced apart, a common gel layer in electrical contact with both the stimulation electrode and the monitoring electrode. [0019] Preferred implementations of this aspect of the invention may incorporate one or more of the following. The common gel layer may comprise solid gel or hydrogel. [0020] In a fifth aspect, the invention features an electrode assembly for external cardiac pacing and external cardiac monitoring, comprising at least one external stimulation electrode for delivering a pacing pulse, the stimulation electrode comprising a stimulation conductive plate, at least one external monitoring electrode, the monitoring electrode comprising a monitoring conductive plate, a backing layer supporting the stimulation and monitoring electrodes, wherein the stimulation conductive plate and monitoring conductive plate are spaced apart, a first gel layer in electrical contact with the stimulation electrode, a second gel layer in electrical contact with the monitoring electrode, wherein the first and second gel layers are spaced apart, wherein one of the first gel layer or the second gel layer comprises a solid gel or hydrogel, and wherein the other one of the first gel layer or the second gel layer comprises a liquid gel. [0021] In a sixth aspect, the invention features an electrode assembly for external stimulation and/or monitoring of a patient, the assembly comprising at least a first and second electrode supported within the assembly, a first gel layer positioned adjacent the first electrode, a second gel layer positioned adjacent the second electrode, the first and second gel layers having different levels of moisture content, and a moisture vapor barrier layer sized and positioned to retard moisture vapor from migrating from one of the first and second gel layers to the other of the gel layers. [0022] Preferred implementations of this aspect of the invention may incorporate one or more of the following. The electrode assembly may be configured for cardiac stimulation, and the first electrode may comprise a stimulation electrode and the second electrode may comprise a monitoring electrode. The first gel layer may comprise a liquid gel and the second gel layer may comprise a solid gel. The first gel layer may comprise a solid gel of one moisture content, and the second gel layer may comprise a solid gel of a second moisture content greater than the first content. The vapor barrier may comprise a polyester film. The vapor barrier may comprise an aluminum film. [0023] In a seventh aspect, the invention features a multi-electrode assembly for cardiac stimulation and monitoring, the assembly comprising a monitoring electrode configured to monitor electrical potential on the chest of a patient, a stimulation electrode configured to deliver one or more stimulating pulses to the chest of a patient, an electrode cable having first and second cable ends, the first cable end configured for connection to an external cardiac device and the second cable end configured for connection to the monitoring electrode and to the stimulation electrode, and a non-linear circuit element electrically interposed between the second cable end and the stimulation electrode, the non-linear circuit element being configured to conduct during delivery of the stimulating pulses and to block conduction in the presence of a residual potential on the stimulating electrode following delivery of a stimulation pulse. [0024] Preferred implementations of this aspect of the invention may incorporate one or more of the following. The non-linear circuit element may comprise one or more diodes or gas discharge tubes. The non-linear circuit element may comprise at least two non-linear circuit elements forming parallel paths between the cable and the stimulation electrode, and with the polarity of the elements being opposite along the two paths, so that a biphasic stimulation waveform can be delivered to the stimulation electrode, with current flowing through one of the paths in one polarity of the waveform and through the other of the paths in the other polarity of the waveform. Conductance in the presence of a residual potential on the stimulation electrode may be blocked along one of the parallel paths by setting the net offset potential of the one or more elements in that path to greater than the expected residual potential. The non-linear circuit element may comprise one or more transistors. The non-linear circuit element may generally block current flow in one direction and may permit current flow in the opposite direction. The electrode cable may comprise a single conductor, and the first and second cable ends may be first and second ends of the single conductor. The invention may further comprise a high-impedance element that is positioned in the electrical path between the electrode cable and the monitoring electrode and configured to reduce the level of current flowing to the monitoring electrode during delivery of a stimulation pulse to the stimulating electrode. [0025] Among the many advantages of the invention (some of which may be achieved only in some of its various aspects and implementations) are the following: Reducing the stimulation artifact has the advantage that stimulation and monitoring electrodes may be placed in close proximity on the exterior of the body. This allows, for example, one stimulation and one or more monitoring electrodes to be combined optionally in a single assembly. With multiple electrodes combined in one assembly, cabling and connections between the electrodes and the stimulation/monitoring device can also be improved. Combining the monitoring and stimulation electrodes in one assembly can be a great help in emergency situations, as it can reduce the time required to apply and connect the electrodes. [0026] Other features and advantages of the invention will be found in the detailed description, drawings, and claims. DESCRIPTION OF DRAWINGS [0027] FIG. 1 is a schematic of a prior art arrangement of stimulation and monitoring electrodes. [0028] FIG. 2 is a diagrammatic, plan view of one implementation of a plurality of monitoring electrodes positioned near a stimulation electrode. [0029] FIG. 3 is a diagrammatic, plan view of another implementation of a plurality of monitoring electrodes positioned near a stimulation electrode. [0030] FIG. 4 is a diagrammatic, plan view of another implementation of a plurality of monitoring electrodes positioned near a stimulation electrode. [0031] FIG. 5 is an electrical schematic of an implementation in which variable impedances are provided at the inputs of the differential amplifier forming the potential difference between two monitoring electrodes. [0032] FIG. 6 is a diagrammatic, plan view of another implementation of a plurality of monitoring electrodes positioned near a stimulation electrode. [0033] FIG. 7 is a block diagram of one implementation of deriving an estimate of standard 3-lead ECG signals by transforming the non-standard ECG signals detected using the electrodes shown herein. [0034] FIG. 8 is a diagrammatic, plan view of an implementation in which diodes are used to reduce the number of electrical leads to the electrode assembly. [0035] FIG. 9 is an electrical schematic of one implementation for forming the difference between the signal detected on two monitoring electrodes. [0036] FIG. 10 is a diagrammatic, plan view of an implementation in which a single monitoring electrode is combined with a stimulation electrode. [0037] FIG. 11 is a schematic illustrating the physics of current flow between two stimulation electrodes and ECG signal detection from two monitoring electrodes. [0038] FIG. 12 is a diagrammatic, partially schematic view of an electrode implementation in which a stimulation electrode of one polarity is divided into three smaller electrodes, all three of which may be used for stimulation, and two of which may be used for ECG monitoring. [0039] FIG. 13 is a diagrammatic, plan view of an electrode implementation in which a stimulation electrode of one polarity is divided into two smaller stimulation electrodes. [0040] FIG. 14 is a diagrammatic, partially schematic view of an electrode implementation in which a stimulation electrode of one polarity is divided into two smaller stimulation electrodes, and separate monitoring electrodes are positioned at the center of each of the smaller stimulation electrodes. [0041] FIG. 15 is a plan view of an implementation in which two chest electrode assemblies, the front assembly having a stimulation electrode and three monitoring electrodes, and the back assembly having just a stimulation electrode, have a common electrical connector for stimulation. [0042] FIG. 16 is a cross-sectional, exploded view taken along 16 - 16 of FIG. 15 , showing the construction of the front electrode. [0043] FIG. 17 is a cross-sectional, exploded view taken along 17 - 17 of FIG. 15 , showing the construction of the posterior (or back) electrode. [0044] FIG. 18 is a diagrammatic plan view of the implementation of FIG. 2 and the locations of standardized, 3-lead electrodes. [0045] FIG. 19 shows an example of standard monitoring vectors synthesized from nonstandard electrode positions using a matrix transformation. [0046] FIG. 20 is a cross-sectional, diagrammatic view of an electrode implementation with an internal vapor barrier. [0047] FIG. 21 is a cross-sectional view of the layers of one possible vapor barrier used in the implementation of FIG. 20 . [0048] FIG. 22 shows two ECG monitoring signals (upper two signals) and a scaled sum of the signals (lower signal). DETAILED DESCRIPTION [0049] There are a great many possible implementations of the invention, too many to describe herein. Some possible implementations that are presently preferred are described below. It cannot be emphasized too strongly, however, that these are descriptions of implementations of the invention, and not descriptions of the invention, which is not limited to the detailed implementations described in this section but is described in broader terms in the claims. [0050] One implementation is illustrated in FIGS. 2 and 15 - 17 . A front electrode 14 includes three monitoring electrodes 20 positioned equidistant from a central stimulation electrode 18 . All three monitoring electrodes 20 and the stimulation electrode 18 are supported on a common assembly. A back electrode 12 includes only a stimulation electrode 16 , but may optionally also include one or more integrated monitoring electrodes as well. [0051] The active area of the stimulation electrode is about 10 cm in diameter. The active area of each monitoring electrode is about 2 cm in diameter. The edge of each monitoring electrode active area is spaced about 1 cm from the edge of the adjacent stimulation electrode active area [0052] Various constructions are possible for the electrode pad assemblies. FIGS. 16-17 show one possible construction. Materials have been chosen that provide resiliency and compliance to the skin surface. FIG. 16 shows the electrode assembly configured to be applied to the front of the chest. A foam cover (or backing) layer 24 (e.g., Voltek Volara™) extends fully across the back of the electrode (top surface facing up away from patient). Each of the three monitoring electrodes is formed by securing a nickel plated brass snap 21 to an AgCl post 22 through an opening in the cover layer (alternatively a lead wire may be connected to the monitoring electrodes). Below that is a foam frame layer 28 , which has an opening through which each of the AgCl posts (AgCl plated glass filled ABS) contact a porous foam sponge 23 , which is impregnated with ECG gel 35 (e.g., Pharmaceutical Innovations™ QR). The stimulation electrode 18 is provided by a conductive plate 29 (e.g., tin) in the center of the electrode assembly. The conductive plate is supported beneath the foam frame layer 28 . Beneath the conductive plate, and making conductive contact with the patient, is a conductive layer 30 , e.g., a solid gel such as a hydrogel (e.g., Ludlow™ 63T hydrogel). At one edge, a portion 38 of the conductive plate extends through an opening in the foam frame layer, and is mechanically and electrically connected at 25 to a wire lead 26 . Wire lead 26 extends to an electrical connector 40 , to which the wire lead 26 from the back electrode assembly is also connected. [0053] Various alternatives may be used for the conductive, skin-contacting layers 23 , 30 . These include, but are not limited to, solid conductive gels (e.g., hydrogel), a porous material filled with a liquid gel, and a porous material soaked in a conductive solution such as saline. [0054] FIG. 17 shows the electrode assembly configured to be applied to the back of the chest. It has a similar construction to that of the front electrode, except that it lacks monitoring electrodes, and has a rectangular, rather than circular, stimulation electrode. Conductive plate 33 is supported on the underside of a foam backing layer 32 . A conductive layer 34 , e.g., solid gel such as the same hydrogel as used in the front stimulation electrode, makes contact with the patient. A portion 38 of the conductive plate extends through an opening in backing layer 32 , and is connected to wire lead 26 . An insulator foam backing layer 31 covers the portion 38 of the conductive plate that extends to the top of foam backing layer 32 . [0055] In the implementation of FIGS. 2 and 15 - 17 , the monitoring electrodes 20 are all positioned the same distance from the stimulation electrode 18 . If the electrical currents flowing between the stimulation electrodes are approximately equal in all directions then the artifact measured by each monitoring electrode will be similar and cancel when a potential difference is formed by subtracting the signals. But placing the monitoring electrodes at equal distances from the stimulation electrode is no guarantee that the measured stimulus artifact will be the same in all three monitoring electrodes. Transmission factors, monitoring electrode impedance, the path of current flow, the shape of the electric field, and other variables can influence measured artifact. Some of the transmission factors, e.g., respiration and blood flow, may be time varying. Current flow can be influenced by surface properties and anatomical structures in the body. [0056] However, positioning the monitoring electrodes equal distances from the stimulation electrode may be sufficient in many cases, as it may result in stimulus artifacts that are sufficiently closely matched as to reduce the level of artifact to an acceptable level in the differential signal (the difference in potential between two monitoring electrodes). And the remaining artifact can optionally be reduced further using other methods described below. [0057] Alternatively, the monitoring electrode spacing can be adjusted based on modeling current flows, experimental results, or a priori knowledge of the transmission factors involved. Circuitry in the electrode or in the medical device doing the monitoring may equalize the artifact measured at each electrode by changing a gain or impedance, or by using other known techniques. [0058] Forming the sum of two monitoring electrodes with artifacts of similar magnitude but opposite polarity will also reduce artifact, e.g., the sum of monitoring electrodes relative to a common reference where one is positioned near the positive and one near the negative stimulation electrodes. [0059] In the implementation of FIGS. 2 and 15 - 17 , three monitoring electrodes are provided for the front electrode assembly, which is positioned over the heart. The back electrode assembly does not have any monitoring electrodes. Other implementations may use different numbers of monitoring electrodes on the front assembly, and monitoring electrodes could be included on the back assembly. Measuring a potential difference requires at least two electrodes. Integration of three monitoring electrode with the stimulation electrode over the heart has at least two benefits. First, many ECG monitors use a third electrode to drive common mode signals back to the patient, to improve signal quality in the presence of large common mode signals such as power line interference. If the third electrode is only used for this common mode rejection purpose, its location relative to the stimulation electrode is less important. Second, ECG monitors for three-lead monitoring generally display the potential difference between a selected electrode pair. These differences are called Lead I, Lead II, and Lead III when the electrodes are positioned in conventional locations on the right and left arms as well as the left leg. The monitoring electrodes in the invention do not represent the standard Leads, but still provide three possible potential differences, from which the operator of the ECG monitor may select. The operator may select the view which is most clinically relevant or contains the least artifact during cardiac pacing. In implementations in which three potential differences between pairs of electrodes are sought, the locations of all three monitoring electrodes can be selected to improve artifact cancellation (e.g., each may be equidistant from the central stimulation electrode), so that a choice can be made as to the best two electrodes to use for canceling the stimulus artifact. More than three monitoring electrodes may also be provided. [0060] The monitoring hardware may be configured to detect the artifact-reducing electrode assembly. If it recognizes such an electrode assembly, the hardware may process signals differently and/or change labeling on displays, strip chart recorders, storage devices and external interfaces. The change in labeling will prevent those reviewing the signals from trying to interpret them as a standard electrode configuration (e.g., standard 3-lead). The electrode assembly identification would typically be made through the monitoring portion of the assembly rather than through the stimulation portion, because in some implementations electrical stimulation is allowed to continue even if a switch is made to standard monitoring electrodes when time permits. [0061] Various methods may be used to identify the electrode assembly, including, for example, the following: (1) specific resistances between connector pins are detected by the monitor; (2) voltages, currents, or specific waveforms input to the monitor from the electrode assembly; (3) interfaces to nonvolatile memory or a microprocessor contained within the electrode connector or assembly; (4) pulling unused monitoring channels to specific voltages (currents, or known waveforms) that can be used to identify the cable. An example of the fourth option is connecting a three lead ECG cable to a 10 wire monitor with a special electrode connector so that certain unused inputs are shorted to ground while others are shorted to a specified voltage. Any condition that is unlikely to occur without the connector in place can be used for identification. [0062] FIG. 11 illustrates the physics underlying the ability of some implementations to cancel much of the stimulus artifact from the ECG signal. A stimulus is applied to the patient (represented by the dashed line rectangle) using a pair of stimulus electrodes (therapy pads). Current flows from one therapy pad to another along varying current paths. The figure shows the overly simplified case of there being just three current paths, with one monitoring electrode positioned along each of two of the paths. Resistors are shown along the current paths to represent the resistance experienced by current flowing along particular paths. The values of the resistors are dependent on the placement of the electrodes, and the physical properties of the patient, and the values of the resistors may be time varying (e.g., as the result of respiration). [0063] Each monitoring electrode records some potential owing to the current flowing during a therapy pulse. After the pulse, the therapy pads may remain polarized. The polarization equalizes over time, and the monitoring electrodes record the potential difference due to the polarization. If the polarization has an equal effect on both monitoring electrodes, then the effect of the polarization (what we have called the stimulus artifact) will cancel, and the differential signal will be due to the electrical activity within the body such as the ECG. [0064] Another possible implementation is shown in FIG. 3 . The monitoring electrodes 20 are supported on a common assembly separate from (but, in this example, surrounding) the stimulation electrode 18 . In FIG. 3 the common assembly is an annular in shape to surround a circular stimulation electrode, but other shapes may be used. An advantage of the shapes used in FIG. 3 is that they help guarantee that the monitoring electrodes are equally spaced from the stimulation electrode. Two of the monitoring electrodes are positioned to be equidistant from the stimulation electrode. The third monitoring electrode (at the top of the figure) is shown in a position slightly away from an equidistant location. If the third electrode is not used to form an ECG signal, but is used only for common mode rejection purposes, then it is not necessary that it be equidistant. In other implementations, in which it was sometimes desirable to use the third electrode for forming an ECG signal, it may be decided to place it in an equidistant location just as the other two monitoring electrodes. [0065] Other methods may also be suitable for positioning the electrodes. They may be positioned at set distances from the therapy pad using constant length cables or other physical connection to the therapy pad that allows easy placement at a pre-determined distance. FIG. 4 illustrates one implementation in which placement of the monitoring electrodes around the stimulation electrode is regulated by the length of electrode lead wires extending from the central stimulation electrode. When the wires are fully extended in a radial direction, the electrode positions will be equidistant from the stimulation electrode. Similarly, the wires may be slightly different lengths in order to equalize artifact based on a priori knowledge of the current flow. Alternatively, the separation between monitoring and stimulation electrodes could be prescribed by a mechanical element (e.g., a mechanical cable), rather than by the electrical leads. The electrodes might initially be affixed (prior to their extension) to the therapy pad by an adhesive or a mechanical device (i.e. clip, Velcro, etc). [0066] Another implementation is shown in FIG. 6 . Three groups of multiple monitoring electrodes—with the electrodes in each group being at different locations relative to the stimulation electrode—are shown. In FIG. 6 , there are two monitoring electrodes 20 in each of Group A, B and C. Analog or digital signal processing may be used to produce a combination of the electrodes in a group, so that when the difference between the processed (or weighted) combinations from two groups is taken the artifact is better cancelled in the differential signal. This method provides compensation for irregularities in the current flow or electric field originating from the stimulation electrode, and may be time-varying to compensate for time-varying parameters such as respiration. More than two electrodes may be provided in each group. Not all locations will require forming a weighted combination of a plurality of electrodes. [0067] Synthesized Leads [0068] Good electrode placements for artifact rejection may not be ideal for analysis of monitored signals. E.g., they may not provide a standard clinical ECG signal. Signal processing may be used to derive or synthesize improved or more clinically standardized looking waveforms from the actual monitoring electrodes. This may be accomplished by, in effect, creating a derived (or synthesized) monitoring electrode from combinations of actual monitoring electrodes. A block diagram of one cardiac pacing implementation of this procedure is shown in FIG. 7 . Signals 90 from monitoring electrodes (e.g., ones of the type shown in FIG. 2 ) may optionally be combined with signals from one (or both) stimulation electrode (which during intervals between stimulation pulses can also serve as a monitoring electrode). A signal processing block 92 produces estimates 94 of standard ECG vectors that are more familiar to the user than potential differences formed directly from the nonstandard electrode locations of FIG. 2 . [0069] A preferred implementation is to transform the signals from the monitoring electrodes (and optionally the stimulation electrode) into ECG signals comparable to what would have been detected using the standard 3-lead placement of ECG electrodes (two near the arms, and one near a leg). [0070] To perform the transformation, the coefficients of a linear transformation matrix are derived from a statistically meaningful population of patients, from whom ECG measurements have been taken at both the new monitoring electrode (and stimulation electrode) locations and the conventional 3-lead locations. A least squares fit is done to derive coefficients of the linear transformation matrix. [0071] The prior art taught several methods of synthesizing leads from a reduced or alternate set of electrodes. For instance, Dower's EASI system (U.S. Pat. No. 5,711,304) used five electrodes in non-standard locations on the body to synthesize an estimate of the 12-Lead ECG. Dower placed the electrodes far apart on the body in locations selected for ease of placement and 12-Lead synthesis. The prior art also taught transformations from implanted leads to standardized leads. Implanted electrodes are fixed in position. It is possible to attach standard surface electrodes to the patient and derive the optimal transform. [0072] FIG. 18 and the following discussion provide one mathematical basis for the lead synthesis. The figure shows a round stimulation (pacing/defibrillation) electrode surrounded by three equidistant monitoring electrodes, each spaced from the others at 120 degree angles. The objective of lead synthesis is to convert the monitoring signals from these nonstandard locations to estimates of the standardized Lead I, Lead II, and Lead III difference signals that would be derived from electrodes positioned at the standard right arm (RA), left arm (LA), and left leg (LL) locations and also shown in the figure. [0073] The signals from the nonstandard monitoring locations can be represented by a matrix X containing samples from the monitored electrodes as column vectors. These signals are high pass filtered or processed so that their mean value is zero. In the example set out below, X is an N×2 matrix where N represents the number of samples and two columns are formed from three ECG electrodes. [0074] Since the electrodes need a reference voltage, two independent ECG vectors (V n ) may be produced from these three monitoring electrodes (E n ). [0000] V 1 =E 1 −E 2 [0000] V 2 =E 2 −E 3 [0075] The third vector may be derived from the other two as follows and is omitted from matrix X to avoid a singular or ill-conditioned system of equations below [0000] V 3 =V 1 −V 2 =E 1 −E 2 −( E 1 −E 3 )= E 1 −E 3 [0076] The desired standardized signals can be represented by a matrix Y containing each of the output signals as column vectors with the mean removed, for instance an N×3 matrix where columns 1, 2, and 3 represent Leads I, II, and III respectively. [0077] The goal of lead synthesis is to find a transformation matrix C such that [0000] XC=Y [0078] This can also be written in matrix form as follows [0000] [ X 11 X 12 X 21 X 22 X 31 X 32 ⋮ ⋮ X N   1 X N   2 ]  [ C 11 C 12 C 13 C 21 C 22 C 23 ] = [ Y 11 Y 12 Y 13 Y 21 Y 22 Y 23 Y 31 Y 32 Y 33 ⋮ ⋮ ⋮ Y N   1 Y N   2 Y N   3 ] [0079] The squared error between measured ECG vectors Y and estimated ECG vectors Ŷ can be calculated as [0000] error=Σ( Y−Ŷ ) 2 [0080] The squared error is minimized by calculating C as follows. [0000] C =( X T X ) −1 X T Y [0081] Ŷ is the estimate of Y and can be calculated using the following equation. [0000] Ŷ=XC [0082] The optimal transformation matrix C will generally vary from patient to patient and is based on the relative placement of the electrode assembly and the standard three lead electrodes. However, C can be estimated from a database of known ECG signals and used generically. The operator may have the ability to switch between the sampled ECG vectors and the synthesized leads so the most useful view may be selected. [0083] FIG. 19 illustrates an example of monitoring signals. The signals in the column labeled “Custom Leads” are potential differences measured from a nonstandard electrode configuration such as FIG. 2 . The column labeled “Standard Leads I, II, III” are measured by monitoring electrodes such as the ones in FIG. 1 . The far right column includes estimates of the standard leads synthesized from the nonstandard signals by a matrix transformation. Although not exactly the same as the signals from standardized locations, they are close enough in appearance for many clinical purposes such as calculation of heart rate. [0084] Electrode Construction [0085] The monitoring and stimulation electrodes may vary in composition. Rather than use a conductive polymer material (sometimes called, “solid gel” or “hydrogel”) for both types of electrodes, liquid gel could be used for the monitoring electrodes, and conductive polymer material only for the stimulation electrodes. This has the advantage of better impedance and signal quality shortly after applying the monitoring electrodes to the skin. Conductive polymer pads typically require time for the skin to warm the gel and reduce impedance, whereas liquid gel does not suffer from such delays. Many situations including emergency cardiac pacing or defibrillation are time critical and there may be an advantage to using liquid gels. [0086] It may also be advantageous in some circumstances to use liquid gels (or other conductive agents) for the stimulation electrodes. For instance, a liquid gel may be beneficial if the stimulation electrode is intended for cardiac pacing only. [0087] Other applications may require electrodes (stimulation or monitoring) with a conductive surface(s) but no gel. Conductive gel or electrode paste may be applied to the conductive surface or to the skin as needed. This is generally the preferred method for re-usable ECG or EEG electrodes. [0088] Electrode assemblies containing more than one electrode (e.g., a stimulation 18 and one or more monitoring electrodes 20 ) may include multiple conductors (e.g., tin layers) that contact the skin through a common gel (polymer pad or other) layer. FIG. 10 shows such an implementation. Two therapy pad assemblies are used for stimulation. Each pad assembly includes a stimulation electrode, and at least one of the pad assemblies includes one or more monitoring electrodes. Electrical current is driven between the conductive plates of the stimulation electrodes; the plates are in electrical contact with the skin through a conductive gel. During the electrical stimulus a potential difference exists between the plates. The polarization of the plates may persist for some time after the stimulus. Measuring small changes in voltage between the plates of the stimulation electrodes may be difficult because of the relatively large potential differences. But the potential difference between the plate of a stimulation electrode and the plate of an adjacent monitoring electrode is less than the difference between the plates of two stimulation electrodes, and thus monitoring small voltage changes is more feasible. The relative positions of the stimulation and monitoring electrodes may be determined by the measurements of interest, for instance across the heart. If the same conductive gel sheet covers the plates of the stimulation electrode and the plate of the monitoring electrode then the polarization effect will be similar and the differential signal will be less contaminated with artifact. [0089] In some implementations in which the same electrode assembly has more than one type of gel, a vapor barrier may be provided to retard moisture transfer from one gel to another. The electrode assemblies are typically sealed within a package until use, but while this retards moisture from leaving the interior of the sealed package, it does not prevent moisture transfers within the assembly. A lower moisture gel such as a hydrogel may absorb water from a second (e.g. liquid gel or different hydrogel) electrode over the life of the packaged electrode. A vapor barrier inside the package may be used to seal one gel type from the other to increase shelf life. The vapor barrier may be implemented in a variety of ways including the method described by Dupelle and White in U.S. Pat. Nos. 6,453,205 and 6,280,463, in which a sealed cup is used to contain a liquid gel. [0090] The vapor barrier may be made from commonly used materials such as mylar and aluminum. An aluminum thin film layer may be deposited by the so-called thermal evaporation method whereby aluminum wire is evaporated onto a heated crucible in a vacuum chamber. Some implementations may use an inert material that is non conductive, such as a thin film deposition of SiOx (typically via sputter deposition). Other vapor barriers may also be used. [0091] An exploded cross-sectional view of an electrode with a vapor barrier 50 is shown in FIG. 20 (patient contact surface at top). The outer surface of the electrode is made from a layer of adhesive backed closed cell foam 52 such as Voltek Volara. A second layer of insulating foam 54 creates recessed wells for the monitoring (ECG) electrodes. A thin vapor barrier 50 surrounds the ECG well and adheres to the surrounding foam. [0092] The ECG electrode wire may be riveted ( 56 ) through an insulated vapor barrier to maintain the seal. Alternately, the vapor barrier may be a conductive metal such as tin and the wire may be soldered or otherwise connected directly to the vapor barrier. [0093] The entire electrode assembly is placed on a release liner 58 (e.g., silicon impregnated polyethylene). Peeling off the release liner also uncovers the ECG electrodes since the top of the vapor barrier has a stronger bond to the liner than it does to the bottom part of the vapor barrier. [0094] The vapor barrier may be constructed in various ways, but one possibility is shown in FIG. 21 , wherein two layers of polyester (e.g., Mylar) and aluminum are bonded face to face. [0095] Electrical Circuitry [0096] FIG. 9 shows one possible analog electrical circuit that can be used to implement artifact rejection. The signal from each of two monitoring electrodes (Electrode 1 and Electrode 2) is buffered through inverting amplifiers A1 and A3, respectively. The buffered signal is fed through a low pass filter, which may be tuned using a variable capacitor to change the time constant. Although a variable capacitor 60 is shown in the circuit, a variable resistor or some other combination of tunable circuit elements may be used. The filters may be set to adjust for different delays in the two input signals so that most of the energy from the artifact will cancel when the signals are subtracted. [0097] FIG. 9 also shows variable gain amplifiers A2 and A4, which allow the signal from each electrode to be scaled so that the magnitude of the artifact is similar in both signals and will cancel when subtracted in the output amplifier A5. With sufficient signal to noise ratio (SNR), only one programmable gain amplifier is needed, provided it can attenuate the signal as well as amplify it. [0098] One example of scaling is an implementation in which two monitoring vectors P1 and P2 are calculated from the signals detected at three electrodes, as follows. [0000] P 1=(electrode 1)−(electrode 3) [0000] P 2=(electrode 2)−(electrode 3) [0099] Then a scaled output Y can be calculated as [0000] Y =( c 1 ×P 1)+( c 2 ×P 2) [0100] The constants c1 and c2 may be selected in some implementations so that the magnitude of the artifact in the two monitoring vectors P1, P2 are approximately equal so that the artifact cancels in the scaled output Y. In other implementations, one of the vectors is used without being scaled (so that no constant is necessary). [0101] FIG. 22 shows an example of how the artifact may be reduced in some implementations with a 100 mA stimulus. The unscaled difference signals (vectors) P1 and P2 (the top two signals) both contain appreciable artifact. But the scaled difference signal (bottom signal) has a substantially reduced artifact, less than in either of the original difference signals. The constants c1 and/or c2 may be derived mathematically by comparing the artifact or may be tuned by the operator (e.g. by twisting a dial) to minimize artifact. The scaling may affect the shape of the resultant monitoring signal (e.g., it may not have magnitudes relevant for diagnostic purposes), but it may be useful for determining heart rate or the general shape of the ECG. The scaling may be implemented in hardware or software, and the constants may be positive or negative depending on the direction of the artifact in each monitored difference signal (vector). [0102] To make it possible for the circuitry to adapt quickly to new patients and new electrodes, some implementations would use digitally controlled components such as (but not limited to) programmable gain amplifiers, digitally controlled variable resistors, and capacitors or inductors that can be switched in or out of the circuit (e.g., with analog switches). Manually adjustable components may also be used, and set by the operator. [0103] The signal processing shown in FIG. 9 may alternatively be implemented using digital or software processing of the sampled signal, or with a combination of analog and digital signal processing. The circuit is preferably designed so that the artifact will not saturate the input amplifiers or converters during periods of interest for monitoring. Digital signal processing may allow for more flexibility in delaying or processing the signals. Digital processing requires sampling the raw signals from each electrode relative to a common reference. Complex filters and/or adaptive gain estimates may also be used in either a digital or analog implementation. [0104] Impedance Adjustment & Common Mode Rejection Circuitry [0105] Another technique for reducing the artifact in the differential signal acquired from two monitoring electrodes is adjusting the input impedance in the electrical circuit that detects the potential at the monitoring electrodes. The artifact will be minimized if the impedance of each monitoring electrode is equal. Electrode impedance can be directly measured or estimated from the artifact. The impedance can be measured by applying a therapy pulse at low or full power, or by using sine waves, chirps, or other arbitrary waveforms suitable for this purpose. The resulting voltage or current waveform measured at each monitoring electrode (or between the two electrodes) can be used to estimate the impedance (or impedance mismatch). [0106] One implementation of an impedance balancing circuit is shown in FIG. 5 , in which the level of the stimulus artifact at the two electrodes is better equalized, thereby reducing the level of artifact in the differential signal. By balancing the impedance of the monitoring electrodes, it may not be necessary to connect a patient drive electrode to assist in common mode rejection. [0107] The circuit in FIG. 5 shows two monitoring electrodes 70 , 72 (upper left) and a patient drive electrode 74 (lower left). Each electrode is shown as an RC element, and it should be noted that these values may vary over time (e.g., from respiration). The conductive gel's contact with the skin may be different at each electrode, resulting in an impedance imbalance between electrodes. [0108] The monitored signal is typically of small magnitude compared to the stimulus artifact and other common mode signals such as power line interference. During or shortly after a stimulation pulse, two monitoring electrodes positioned at the same potential in the electric field between the two stimulation electrodes will measure a very large common mode signal as the result of the polarization on the two stimulation electrodes, i.e., the stimulus artifact. But the circuit measuring the difference between the two monitoring electrodes may not reject the large stimulus artifact if the impedances are not properly balanced. [0109] Several methods are known in the art for canceling common mode signals, and these may be applied to improve cancellation of the stimulus artifact. Each of the leads running to the stimulation and monitoring electrodes has a cable shield 76 surrounding it. The circuit drives the cable shield with the common mode signal through amplifier A1. This reduces the effect of cable capacitance by maintaining signal and shield at similar potentials. [0110] The shield drive is also integrated and inverted by A2 and driven back to the patient. This has the effect of reducing common mode signals by moving the reference level of the circuit close to the common mode of the patient. [0111] Currents due to common mode signals may flow from the patient through various return paths including the patient or shield drive. Circuit elements may be adjusted to correct for imbalances in electrode impedance to reduce common mode signals. The figure shows variable resistors and capacitors controlled by an impedance compensation circuit 78 . [0112] The impedance matching circuit may be simpler to implement if placed directly between the two monitoring electrodes, but this may require complex cabling and not be as practical. [0113] Impedance matching elements may include components commonly used in the art, including (but is not limited to) trim pots, manually-adjustable capacitors, digitally-controlled variable resistors or capacitors, or one or more RC elements with analog switches. Inductors or other passive components may also be used. [0114] The impedance compensation controller may include a mix of analog and/or digital processing. The impedance may be measured directly by applying a current to the patient in the form of sine waves, chirps, or therapy pulses at full or reduced intensity. There are other methods well known in the state of the art. It may also be measured indirectly by estimating the imbalance from power line interference or artifact from pulses delivered during therapy. The controller adjusts the digitally controller circuit elements and may monitor changes in common mode artifact. Alternately, the impedance may be adjusted manually by the operator of the device, but this may be time consuming and require some expertise not shared by all device operators. [0115] Cables and Connectors [0116] Various arrangements of cables and connectors can be used for connecting the stimulation (therapy pads) and monitoring electrodes to their associated medical device (e.g., a combined CPR prompting, defibrillation, and pacing device). For example, the therapy electrodes may be wired to a therapy connector. The wires may be made from any electrically conductive material and may be permanently attached to the electrodes or may attach to some or all of the electrodes using a connector. A connector allows the wires to be reused but may be less reliable and takes time for connection. It has the disadvantage of allowing the operator to make a mistake by forgetting to connect a wire or by connecting a wire to the wrong electrode. [0117] The monitoring electrodes may be wired to a monitoring connector. The therapy and monitoring connectors may be physically separate or combined into a unified connector. The unified connector may be one piece or made up of a monitoring connector and therapy connector that can come apart or move in such a way that one or both of the connectors will be attached to the medical device. [0118] This may be accomplished with wires permanently attached to the electrodes and running individually, or attached together in a single cable, to a connector. Attaching the single connector to the medical devices ensures that all connections are properly made. However, this requires a separate input on the medical device for standard leads to be connected, and an internal switching mechanism capable of selecting between electrodes or displaying both sets of leads. [0119] Alternatively, separate connectors may be used for the therapy pad and monitoring electrodes. This has the advantage of allowing the operator to replace one or both of these cables with other monitoring electrodes or pads, and eliminates the need for a switching mechanism. This type of cabling may allow the electrodes to be used on devices not originally designed for this purpose. [0120] Some of the multi-lead cable constructions shown in the application of Peter A. Lund et al., entitled, “Medical Cable”, filed on even date herewith (and herein incorporated by reference), may be used in some implementations. [0121] Shared Wires for Therapy and Monitoring Electrodes [0122] To simplify cabling and reduce cost, therapy pad wires may be shared with the monitoring electrodes in certain applications. This is especially relevant where pulses are applied to the therapy pads for short durations, and monitoring is not required during this time. Switching circuitry or non-linear circuit elements including but not limited to, diodes or gas discharge tubes may be used for this purpose. [0123] A possible implementation of a shared wire electrode assembly is shown in FIG. 8 . Diodes 81 , 82 allow the flow of current to the stimulation electrode 85 (which conducts to the patient through gel layer 86 ) but block a reverse flow of current back to the monitoring channel during the monitoring phase following stimulation. Using diodes oriented in both directions allows the delivery of biphasic stimulation waveforms while preventing polarizations (e.g. of less than a diode drop) from being measured by the monitoring circuit. More than one diode may be used in either direction to split high currents or for fault tolerance. Optionally, a resistor 83 or high impedance monitoring electrode 84 may reduce current flow through the monitoring electrode 84 during therapy. Implementations such as that of FIG. 8 , as well as other shared wire implementations, have the advantages of reduced clutter and reduced chance of wrong connections. In some implementations, the elimination of additional cables may also reduce overall manufacturing cost. [0124] Cancellation with Multiple Stimulating Electrodes [0125] The configuration shown in FIG. 14 uses a plurality (two shown) of stimulation electrodes 18 of one polarity. Current flows from one positive stimulation electrode 16 to two negative stimulation electrodes 18 . In other implementations both the positive and negative stimulation electrodes could be divided into two or more electrodes. A monitoring electrode 20 is positioned in the center (but not in contact with) each negative stimulation electrode. If both of the negative stimulation electrodes are positioned so that each receives (sinks) approximately the same current, the artifact measured by the two monitoring electrodes will be approximately equal and will thus cancel when the difference is taken between the two electrodes. [0126] Another configuration using a plurality of stimulation electrodes 18 of the same polarity is shown in FIG. 12 . In this implementation, an electrode of one polarity is divided into three stimulation electrodes 18 (even more separate electrodes could be used), and the other polarity is handled by just a single electrode 16 (but alternatively this polarity could, also, be handled by a plurality of electrodes). The multiple stimulation electrodes of the same polarity have separate conductive plates (e.g., tin), and may have a common conductive gel underlying them, or separate gel areas. All three of the stimulation electrodes are used together during stimulation, and two of the stimulation electrodes are also used for monitoring (as shown by the left and right electrodes leading to the differential amplifier). The two electrodes used for monitoring are positioned across the heart and aligned to produce an ECG vector of interest. These two electrodes may be smaller than the central electrode. Using the two stimulation electrodes for monitoring is possible because the polarization on the two electrodes is approximately equal and of the same polarity. The three electrodes may be part of one assembly, or be split into two or three assemblies for flexibility in placement. The combined area of the three electrodes is made sufficient for the therapy being delivered (e.g., defibrillation or pacing). [0127] Still another implementation is shown in FIG. 13 . Here the central electrode has been eliminated, and one stimulation polarity is divided into two electrodes 18 positioned at two sides of the heart, and aligned to produce an ECG vector of interest. Both electrodes are using during stimulation, and monitoring is done by forming the difference between the two electrodes. [0128] Processing to Further Mitigate Artifact [0129] The stimulus artifact may be mitigated further using analog or digital signal processing. Such processing may include adaptive blanking of the artifact where filter inputs, displays, or strip chart recorders are blanked, zeroed, or otherwise modified during the artifact. An algorithm or adaptive method may be used to adjust the blanking time based on the measured signals. This may allow the operator to view more of the monitored signal if the artifact is cancelled quickly and to prevent confusing artifacts from being displayed if the artifact takes longer to dissipate. [0130] Many other implementations other than those described above are within the invention, which is defined by the following claims.

1a

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. Ser. No. 14/817,318 filed Aug. 4, 2015, the disclosure of which is incorporated herein in its entirety by reference. TECHNICAL FIELD The present invention relates to a method for treating detrusor hyperactivity with impaired contractility (hereinafter referred to as “DHIC”), comprising the step of administering a therapeutically effective amount of 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one, a salt thereof, or a solvate thereof. BACKGROUND ART 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one (hereinafter referred to as “Compound 1 of the present invention”) is a compound having a structure represented by Formula (1) below. Patent Document 1 discloses that a cyclohexenone long-chain alcohol comprising the compound represented by Formula (1) has an effect of promoting neurite growth, and thus is useful as a preventive and/or therapeutic agent for brain disorders such as dementia. Patent Document 2 discloses that a cyclohexenone long-chain alcohol comprising the compound represented by Formula (1) is useful as a therapeutic agent for treating dysuria. However, the effect as a therapeutic agent for treating dysuria shown in Patent Document 2 was confirmed only against dysuria with depressed bladder function (the effect was confirmed by the improvement in maximum voided volume, bladder capacity, and micturition efficiency). More specifically, the effect of ameliorating detrusor hyperactivity with impaired contractility of Compound 1 of the present invention has been completely unknown. In normal micturition function, detrusor doesn't contract during storage phase (urine can be reserved in bladder), and contracts during only voiding phase. In storage dysfunction disease (overactive bladder), detrusor overactive occurs during storage phase, so, urine can't be reserved fully in bladder. Medicines, such as an anti-cholinergic agent and a β3 receptor agonist, are effective for storage dysfunction disease. While on the other hand, in urine-voiding dysfunction disease (underactive bladder), an increased residual urine volume is a problem. Medicines, such as a cholinesterase inhibitor and a cholinergic agonist, are used for urine-voiding dysfunction disease. However, it is generally known that an effective agent for overactive bladder does not work or is even detrimental against underactive bladder (Non-patent Document 1, Non-patent Document 2). Also, it is known that an effective agent for underactive bladder is invalidity or detrimental against overactive bladder (Non-patent Document 3). In these ways, although there are some therapeutic approaches against an individual disease of overactive bladder or underactive bladder, there is merely agent to be expected effective against both overactive bladder and underactive bladder. DHIC is a disorder which presents both of detrusor overactive and detrusor impaired contractility in the body of the same individual (Non-patent Document 4, Non-patent Document 5). Because detrusor overactive occurs additionally with a residual urine volume increased by detrusor impaired contractility, it induces high-pressure during storage phase and incontinence. Further, if such condition is left unattended without appropriate care, it results in a sever disease such as urinary-tract infection, upper urinary tract disorder, or renal dysfunction. DHIC is clinically diagnosed by confirming coexistence of detrusor overactive during storage phase and detrusor impaired contractility during voiding phase using Pressure-Flow Study (nomogram analysis is useful for the diagnosis) (Non-patent Document 4, Non-patent Document 5). Also, because DHIC is disorder which presents both of detrusor overactive and detrusor impaired contractility, the diagnosis of overactive bladder and underactive bladder can be available for diagnosis of DHIC (Non-patent Document 6, Non-patent Document 7). Those are, overactive bladder is diagnosed by subjective symptom (urgency, incontinence, pollakiuria etc.), and underactive bladder is diagnosed by subjective symptom (forceless urinary stream, terminal dribbling, retarded micturition, abdominal straining to urinate, a feeling of residual urine, urinary retention etc.), uroflowmetry, and measurement of residual urine volume etc. Then DHIC can be diagnosed by confirming coexistence of both the disorders. In therapeutic strategy for DHIC, because conflicting dysfunctions of detrusor overactive and detrusor impaired contractility coexist in the body of the same individual, it is therapeutic high-difficult dysuria. As described above, generally, the ameliorating agent with only either of overactive bladder or underactive bladder was clinically insufficient effect against patients with DHIC. Considering this situation, we need the therapeutic agent for DHIC which presents both of detrusor overactivity and detrusor impaired contractility in the body of the same individual. It was recently reported that an α1-blocker such as Tamsulosin etc., which was effective on urine-voiding dysfunction (underactive bladder), was also effective on overactive bladder (Non-patent Document 8). CITATION LIST Patent Documents Patent Document 1: International Publication WO1999/008987 Patent Document 2: International Publication WO2002/066024 Non-patent Documents Non-patent Document 1: J Smooth muscle Res 48, p 115-124 (2012) Non-patent Document 2: Br J Urol 82, p 272-277 (1998) Non-patent Document 3: J Urol 174, p 1137-1141 (2005) Non-patent Document 4: JAMA, 257, p 3076-3081 (1987) Non-patent Document 5: Rev Hosp Clin Fac Med Sao Paulo, 59, p 206-215 (2004) Non-patent Document 6: Neurourol Urodyn, 29, p 4-20 (2010) Non-patent Document 7: Eur Urol, 65, p 389-398 (2014) Non-patent Document 8: JAMA 296, p 2319-2328 (2006) SUMMARY OF INVENTION Technical Problem An object of the present invention is to provide a method for treating DHIC by improving both of detrusor overactivity and detrusor impaired contractility. Solution to Problem The inventors of the present invention carried out extensive research to attain the above object, and found that 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one represented by Formula (1) below ameliorates both of detrusor overactivity and detrusor impaired contractility, and thus is useful as a therapeutic agent for treating a disorder based on DHIC. More specifically, the present invention provides a method for treating a disorder that presents both detrusor overactivity and detrusor impaired contractility, comprising the step of administering a therapeutically effective amount of 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one, a salt thereof, or a solvate thereof. Further, the present invention provides a method for treating DHIC, comprising the step of administering a therapeutically effective amount of 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one, a salt thereof, or a solvate thereof, to a patient with DHIC. Further, the present invention provides a method of ameliorating a disease that presents both of detrusor underactivity and detrusor hyperactivity, using 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one, a salt thereof, or a solvate thereof, to a patient that presents both of detrusor underactivity and detrusor hyperactivity. Advantageous Effects of Invention The present invention enables effective treatments of DHIC. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 shows representative cystometry charts of rat dysuria model that presents DHIC. FIG. 2 shows the effects of Compound 1 of the present and α1-blocker (Tamsulosin) on detrusor contractility in rat dysuria model that presents DHIC. Sham: n=11, Control (6% Gelucire): n=19, Compound 1 of the present invention (10 mg/kg×2/day p.o.): n=8, Tamsulosin (0.3 mg/kg, i.v.): n=6 DESCRIPTION OF EMBODIMENTS Compound 1 of the present invention is a known compound, and is produced by, for example, the method disclosed in International Publication WO1999/008987. The term “treatment” in the present invention means maintenance treatment for alleviating the symptoms and preventing the recurrence by improving a disease that presents both of detrusor overactivity and detrusor underactivity, especially, maintenance treatment for alleviating the symptoms and preventing the recurrence by ameliorating DHIC. In the present specification, the phrase “a treatment of DHIC” means a method of ameliorating a disease that presents both of detrusor overactivity during storage phase and detrusor impaired contractility during voiding phase. Compound 1 of the present invention may be formed acid adduct salt, or base adduct salt. And the present include the present invention to the extent that the salt is a pharmaceutically acceptable salt thereof. Specifically, it includes an acid adduct salt with an inorganic acid such as hydrochloric acid, hydrobromic acid, hydroiodic acid, sulfuric acid, nitric acid, or phosphoric acid etc.; an acid adduct salt with an organic acid such as formic acid, acetic acid, propionic acid, oxalic acid, malonic acid, succinic acid, fumaric acid, maleic acid, lactic acid, malic acid, citric acid, tartaric acid, carbonic acid, picric acid, methansulfonic acid, p-toluenesulfonic acid, or glutamic acid etc.; salt with an inorganic base such as sodium, potassium, magnesium, calcium, or aluminum etc.; salt with an organic base such as methylamine, ethylamine, meglumine, or ethanolamine etc.; salt with basic amino acid such as lysine, arginine, or ornithine; ammonium salt etc. Examples of the solvent of the solvate of Compound 1 of the present invention include water, methanol, ethanol, isopropanol, acetonitrile, tetrahydrofuran, ethyl acetate, toluene, hexane, acetone, methyl ethyl ketone, and methyl isobutyl ketone etc. 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one, a salt thereof, or a solvate thereof of the present invention can be prepared into various dosage forms by using known preparation methods using a pharmaceutically acceptable carrier. The dosage form is not particularly limited, and examples thereof include oral agents such as tablets, coated tablets, pills, powdered drugs, granules, capsules, liquids, suspensions, or emulsions; and parenteral agents such as injections or suppositories. In preparing tablets, examples of carrier include excipients such as lactose, sucrose, sodium chloride, glucose, urea, starch, calcium carbonate, kaolin, crystalline cellulose, or silicic acid; binders such as water, ethanol, propanol, cornstarch, simple syrup, glucose solution, starch solution, gelatin solution, carboxymethylcellulose, shellac, methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, potassium phosphate, or polyvinyl pyrrolidone; disintegrants such as dry starch, sodium alginate, powdered agar, powdered laminaran, sodium hydrogencarbonate, calcium carbonate, polyoxyethylene sorbitan fatty acid ester, sodium lauryl sulfate, stearic acid monoglyceride, or lactose; disintegration inhibitors such as sucrose, stearic acid, cacao butter, or hydrogenated oils; absorbefacients such as quaternary ammonium salts or sodium lauryl sulfate; moisturizers such as glycerin or starch; adsorbents such as starch, lactose, kaolin, bentonite, or colloidal silicic acid; and lubricants such as purified talc, stearate, boric acid powder, or polyethylene glycol. Further, the tablets may be generally coated tablets such as sugar-coated tables, gelatin-coated tablets, enteric-coated tablets, film-coated tablets, double-coated tablets, or multi-coated tablets. In preparing pills, examples of the carrier include excipients such as glucose, lactose, starch, cacao butter, hardened vegetable oil, kaolin, or talc; binders such as gum arabic powder, tragacanth powder, gelatin, or ethanol; and disintegrators such as laminaran or agar. Capsules are usually prepared in a standard method by blending the drug with one or more carriers as exemplified above, and encapsulating the mixture into hard gelatin capsules, soft capsules, etc. In preparing oral liquid formulations, an internal liquid medicine, a syrup, an elixir, or the like, may be prepared by a standard method using sweetening/flavoring agent, buffer, stabilizer, etc. In this case, examples of sweetening/flavoring agents include sucrose, wild orange peel, citric acid, and tartaric acid; examples of buffers include sodium citrate; and examples of stabilizers include tragacanth, gum arabic, and gelatin. In preparing suppositories, examples of usable carriers include polyethylene glycol, cacao butter, higher alcohols, esters of higher alcohols, gelatin, and semisynthetic glycerides. In preparing injections, the liquids, emulsions, and suspensions are preferably sterilized and rendered isotonic to the blood. Examples of diluents for preparing such dosage forms include water, aqueous lactic acid solution, ethanol, propylene glycol, macrogols, ethoxylated isostearyl alcohol, polyoxyethylenated isostearyl alcohol, and polyoxyethylene sorbitan fatty acid ester. In this case, sodium chloride, glucose, or glycerin in an amount sufficient to prepare an isotonic solution may be added to the pharmaceutical formulation. Further, general solubilizers, buffers, anesthetics, and the like, may also be added to the pharmaceutical formulation. Additionally, coloring agents, preservatives, aromatics, flavors, sweetening agents, or other medicinal products may be incorporated, if necessary, into the pharmaceutical formulations. The method for administering the DHIC ameliorating agent of the present invention is not particularly limited, and is suitably selected according to the dosage form thereof, the age, gender, and other conditions of the patient, the severity of the symptoms of the patient, and the like. For example, tablets, pills, powdered drugs, granules, capsules, liquids, suspensions, and emulsions are orally administered. The injections are intravenously administered singly, or as a mixture with a general infusion liquid such as liquid glucose or an amino acid liquid. Further, as necessary, the injections are singly administered intra-arterially, intramuscularly, intradermally, subcutaneously, or intraperitoneally. The suppositories are intrarectally administered. The amount of the compound of the present invention or a salt thereof to be incorporated into each of the above dosage unit form depends on the symptoms of the target patient, or depends on the drug form; however, the amount per dosage unit form is generally preferably about 0.005 to 1,000 mg, more preferably 1 to 800 mg, further preferably 5 to 500 mg for oral agents; about 0.001 to 500 mg, more preferably 0.02 to 400 mg, further preferably 1 to 250 mg for injections; and about 0.01 to 1,000 mg, more preferably 1 to 800 mg, further preferably 5 to 500 mg for suppositories. Additionally, the daily dose for an adult of the drug to be administered with the above dosage form is generally about 0.005 to 5,000 mg, preferably 0.01 to 2,000 mg, more preferably 10 to 1600 mg, further preferably 20 to 800 mg, although such doses depend on the symptom, body weight, age, gender, etc., of the patient. For each day, the daily dose is preferably taken at one time, or divided into two to four administrations. The present invention is more specifically described below in reference to the Test Examples; however, the present invention is not limited to these examples. EXAMPLES Test Example 1 Preparation of Rat Model that Presents DHIC The models were produced by partial ligation (φ1.57 mm) of urethra in rats (9 weeks, female, Sprague-Dawley). Six weeks after preparation of the model, the rats were released the ligation. The next day, the intravesical pressure and the voided volume were measured under awake condition. And the detrusor contractility during voiding phase was evaluated by nomogram analysis using Qmax and Pdet. Additionally, the detrusor overactivity, as index of overactive bladder, and the increase of residual urine volume, as index of underactive bladder, were evaluated. FIG. 1 shows representative cystometry charts. In the dysuria model rat (control) compared to sham rat, there is the characteristics of detrusor hyperactivity with impaired contractility that are characterized by remarkable overactivity and increased residual urine volume (Table 1). TABLE 1 The effects of Compound 1 of the present invention and α1-blocker (Tamsulosin) on detrusor overactivity and residual urine volume in rat dysuria model that presents DHIC. Detrusor Residual urine overactivity volume Group n (times/min) (mL) Sham 11 0.19 ± 0.09 0.10 ± 0.03 Control 19 1.73 ± 0.10 # 0.57 ± 0.06 # Compound 1 of 8 0.63 ± 0.10* 0.28 ± 0.13* the present invention Tamsulosin 6 0.68 ± 0.33 § 0.64 ± 0.08 #: p < 0.05 vs. Sham group (unpaired Student's t-test) *p < 0.05 vs. Control group (unpaired Student's t-test) §: p < 0.05 vs. Control group (unpaired Student's t-test) Through evaluation of detrusor contractility during voiding phase in refer to nomogram analysis which are used in clinical sites (Non-patent Document 9: Urol Clin North Am, 17, p 553-566 (1990)), because the plot of control group is positioned in a position relatively close to the origin compared to it of sham group (the distance from the origin: Sham group 24.75±3.14, control group 4.24±0.53, p<0.05), it is judged that reduction of detrusor contractility occurs in the rat dysuria model ( FIG. 2 ). In the rat dysuria model from these findings, it is confirmed that the detrusor overactivity during storage phase and the reduction of detrusor contractility during voiding phase in nomogram analysis coexist in the body of the same individual which is clinical diagnostic index of DHIC. It is found that the rat dysuria model is able to be evaluated as model of DHIC. Test Example 2 Effects of Ameliorating Detrusor Overactivity and Detrusor Impaired Contractility in Rat Dysuria Model that Presents DHIC The effect of 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexene-1-one (hereinafter referred to as “Compound 1 of the present invention”) on DHIC was evaluated. The dysuria models in this example were prepared in the same manner as in Test Example 1. The test drugs (vehicle: 6% Gelucire, Compound 1 of the present invention 10 mg/kg) were orally administered to each group after two weeks from the preparation of the models twice a day for four weeks. On the day of the final administration, the rats were released the ligation of urethra. The next day, the intravesical pressure and the voided volume were measured using cystometry under conscious condition. The detrusor overactivity, as an index of overactive bladder, and the increase of residual urine volume, as an index of underactive bladder, were evaluated. Additionally, the detrusor contractility during voiding phase was evaluated by nomogram analysis using Qmax and Pdet. In comparison with the detrusor overactivity (1.73±0.10 times/min) and the residual urine volume (0.57±0.06 mL) in control group receiving vehicle (6% Gelucire), detrusor overactivity (0.63±0.14 times/min) and residual urine volume (0.28±0.13 mL) in the group receiving Compound 1 of the present invention were significantly improved (Table 1). Additionally, from the result of evaluation using nomogram analysis, because the plot of Compound 1 of the present invention group is positioned in a position relatively distant from the origin compared to it of control group (the distance from the origin: 10.5±2.3, p<0.05), it is judged that detrusor contractility is improved in Compound 1 of the present invention group compared to control group ( FIG. 2 ). In DHIC model that detrusor overactivity and detrusor impaired contractility coexist, it is recognized that Compound 1 of the present invention possesses effect for ameliorating both of detrusor overactivity and detrusor impaired contractility. Comparative Example 1 Effects of α1-Blocker (Tamsulosin) on Detrusor Overactivity and Detrusor Underactivity/Impaired Contractility in Rat Dysuria Model that Presents DHIC In the same manner as Test Example 1, the rats were released the ligation of urethra at six weeks after the preparation of the model. The next day, the intravesical pressure and the voided volume were measured using cystometry under conscious condition. The detrusor overactivity, as an index of overactive bladder, and the increase of residual urine volume, as an index of underactive bladder, were evaluated. Additionally, the detrusor contractility during voiding phase was evaluated by nomogram analysis using Qmax and Pdet. Tamsulosin (3 μg/kg) was administered intravenously to the dysuria rat at the evaluation (six weeks after preparation of the model). Detrusor overactivity was significantly improved in Tamsulosin (3 μg/kg) group (0.68±0.33 times/min) than control group (1.73±0.10 times/min) (Table 1). However, Tamsulosin (3 μg/kg) has no effect on residual urine volume (Table 1) and detrusor contractility in nomogram analysis ( FIG. 2 ). Comparative Example 2 Effects of α1 Blocker (Tamsulosin) on Detrusor Impaired Contractility in Rat Underactive Bladder Model The effects of al blocker (Tamsulosin) on underactive bladder were evaluated. The dysuria models in the present example were prepared by treating 10-week-old female Wistar rats with streptozotocin (65 mg/kg, i.p.). From four weeks after the preparation of the models, Tamsulosin (1 μg/kg/hr) was administered subcutaneously using osmotic pump. Four weeks after the implant of osmotic pump, the intravesical pressure and the voided volume were measured using cystometry under urethane anesthesia condition. And the residual urine volume, as an index of underactive bladder, was evaluated. Table 2 shows the results. In comparison with the Sham group, significant increase of the residual urine volume, which is an index of underactive bladder, was observed in the control group (eight weeks after the development of the disease in the models). Tamsulosin showed significant reduction on the increase of residual urine volume which was observed in the control group. The above results suggest that Tamsulosin improves underactive bladder, that is, detrusor impaired contractility. TABLE 2 Effects of α1 blocker (Tamsulosin) on residual urine volume in rat underactive bladder model Residual urine volume Group n (mL) Control 10 1.11 ± 0.20 Tamsulosin 9 0.47 ± 0.11 § §: p < 0.05 vs. Control group (unpaired Student's t-test) Although an α1blocker, which generally are used as dysuria-treating drug, has effect on underactive bladder (Comparative Example 2) and are also reported effect for improving overactive bladder (Non-patent Document 10: J Urol, 190, p 1116-1122 (2013)), the effect of Tamsulosin was not observed in dysuria (DHIC) that detrusor overactivity and detrusor impaired contractility coexist in the body of the same individual (Comparative Example 1). On the other hand, Compound 1 of the present invention shows effect for ameliorating both dysfunctions in DHIC that detrusor overactivity and detrusor impaired contractility coexist (Test Example 2). Therefore, it is suggested that Compound 1 of the present invention is a useful therapeutic agent for DHIC (Test Example 2).

1a

This is a continuation of application Ser. No. 896,471, filed Aug. 14, 1986, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to catheters, and in particular, to a guiding catheter to be used in the performance of a percutaneous translumenal coronary angioplasty procedure, a guiding catheter which provides variable, operator-controlled flexibility. This feature facilitates introduction and precludes disengagement of the guiding catheter, thus expediting the performance, and enhancing the safety, of the angioplasty procedure. 2. Description of the Prior Art In 1977 Andreas Gruntzig first used a balloon-tipped flexible catheter to percutaneously dilate a region of stenosis within the coronary artery of a patient with atherosclerotic coronary artery disease. Since that time, the incidence of percutaneous translumenal coronary angioplasty has increased exponentially. In the last several years, the performance of this procedure has become routine within most major medical centers throughout the world. Furthermore, with the advent of improved technology and increased operator skill, the indications for this procedure have also substantially increased. Concurrent with the aggressive utilization of this technique, physicians with expertise in angioplasty have been approaching increasingly difficult lesions percutaneously, and physicians with relatively little experience in angioplasty have been attempting to dilate relatively straight forward lesions with minimal formal training. In a routine angioplasty procedure using conventional catheters, a preshaped semi-rigid guiding catheter is introduced into a peripheral artery, advanced over a guidewire along the course of the aorta and subsequently engaged within the appropriate coronary ostium. Once engaged, a second catheter (an angioplasty balloon dilation catheter), equipped with a balloon at its distal aspect and a flexible steerable guidewire, is introduced within the guiding catheter and advanced to within its distal aspect. The guidewire is then advanced within the lumen of the diseased vessel and manipulated across the region of stenosis. By rotating the guidewire, which contains a slight bend, the operator can control the course of the wire and select the appropriate lumen. Once the guidewire is positioned across the region of stenosis, the operator advances the dilation balloon over the guidewire and positions it across the stenotic lesion. The angioplasty is then accomplished by inflating the balloon to about 6-10 atmospheres of pressure. Usually three to four dilations are required for each region of stenosis, with the duration of each dilation varying between 30 to 90 seconds, depending upon anatomic considerations and operator preference. Following the final dilation, the guidewire and angioplasty balloon are withdrawn, leaving the guiding catheter in place. Coronary angiography may then be performed to evaluate the appearance of the vessel following the procedure and to determine the severity of any residual stenosis. There are several major obstacles to the successful performance of the procedure. One major difficulty involves manipulation of the dilation balloon catheter across the region of stenosis within the appropriate coronary artery. Although the guidewire can frequently be advanced across the region with relative ease, manipulation of the balloon across the stenosis is more difficult because the catheter is substantially larger in cross section than the guidewire. Hence, relatively more resistance to the passage of this catheter within the coronary artery is commonly incurred. Merely advancing the angioplasty dilation balloon catheter against resistance often results in disengagement of the guiding catheter from the coronary ostium. Once the disengagement occurs, the angioplasty dilation balloon catheter frequently prolapses in the ascending aorta, precluding further advancement of this catheter. Inability to advance the angioplasty balloon across the stenosis because of instability of the guiding catheter and subsequent prolapse of the angioplasty balloon catheter represents one of the most common reasons for failure during the performance of a coronary angioplasty procedure. The guiding catheter disengages in this circumstance because of its flexibility. The guiding catheter has intrinsic flexibility because it must conform to the configuration of the aorta and aortic arch, which contain both linear and curved segments, during introduction. Insertion of the guiding catheter requires that it be advanced over a guidewire up the aorta, which is relatively straight, and then over the aortic arch. One prior art solution to this difficulty was the manufacture of dilation balloon catheters designed to produce less resistance during manipulation across a stenotic lesion. It was originally proposed that these "low resistance" angioplasty dilation catheters would produce less "back pressure" and in this way preclude disengagement of the guiding catheter. Several approaches were pursued to minimize the resistance characteristics of the balloon catheters including the development of lower profile balloons (when deflated) with smooth, tapered leading edges. By itself, however, this approach did not circumvent the problem. For example, despite extensive research and development, the cross-sectional diameter of the lowest profile dilation catheter currently available is considerably greater than the corresponding diameter of the guide wires used in conventional coronary angioplasty. Hence, despite the development of these low profile dilation catheters, intracoronary resistance to the passage of these catheters remains a considerable problem. Secondly, these smaller catheters do not permit reliable transmission of intracoronary pressures and, for this reason, their use obscures vital hemodynamic monitoring on frequent occasions. And thirdly, the caliber of these low profile balloons, when inflated, is substantially smaller than the corresponding caliber of most conventional angioplasty catheters. Thus, their use frequently necessitates the installation of an intracoronary exchange wire as well as the introduction of a second (larger caliber) angioplasty dilation balloon catheter. The use of this second dilation catheter, and the necessary exchange wire, increases the time and expense of the procedure. Most significantly, the complication rate of the procedure increases as the time for, and number of, dilation balloon changes increases. In the prior art, dislodgment of the guiding catheter was prevented by forcing the guiding catheter down the course of the vessel to be dilated or bending the guiding catheter in such a way that it "banked" off the back wall of the aorta before engaging the coronary ostium. Both techniques are particularly dangerous as they may result in dissection of the coronary artery proximal the region to be dilated. SUMMARY OF THE INVENTION I have developed a guiding catheter which overcomes the foregoing disadvantages of prior art catheters. My catheter allows the operator to control the flexibility of the catheter. This feature permits the operator to select the compliance characteristics which are most suitable for the particular phase of the procedure. For example, during introduction the catheter can be relatively flexible to facilitate advancement over the guidewire within the aorta, to expedite engagement of the coronary ostia, and to minimize the potential risk for catheter-induced vascular damage (a recognized complication of stiff catheters). Following engagement, the catheter can be made relatively inflexible to provide stability during the manipulation of the angioplasty dilation balloon catheter. The enhanced stability of the catheter circumvents the need for forcing the prior art relatively rigid guiding catheter deep within a coronary lumen to achieve stability, as well as the need for the sequential balloon technique. Thus, the controllable flexibility of the catheter contributes to the efficiency, as well as the safety of the procedure. In a preferred embodiment, my catheter includes an elongate housing member having an opening extending from a proximal end to an distal end, and controllable stiffening means coupled to the elongate housing to enable control of the flexibility thereof. Optionally, a second controllable stiffener may be employed to selectively deflect a distal segment of the catheter to more accurately align the catheter with the desired artery. The catheter of my invention is easier to install in the body and engage within the desired coronary artery, while being less traumatic to the patient. It minimizes the time for the angioplasty and precludes, in most cases, the need for sequential balloons and exchange wires. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional view of the heart and aorta showing a stenosis in a coronary artery together with a conventional guiding catheter and dilation balloon. Two inserts have been included for the purpose of orientation; FIG. 2 is a cross section similar to FIG. 1 illustrating one disadvantage of prior art guiding catheters; FIG. 3 illustrates the forces which develop within the guiding catheter as the angioplasty dilation balloon catheter is advanced within (in this case) the left coronary artery; FIG. 4 is a cross section similar to FIG. 1 illustrating one embodiment of the catheter of my invention; FIGS. 5A and 5B illustrates the means by which the preferred embodiment of the catheter of my invention provides additional "back pressure" to oppose the pressures described in FIG. 3; FIG. 6 is a perspective view of the catheter shown in FIG. 4; FIG. 7 is a cross section of the distal end of the catheter shown FIG. 4; FIGS. 8A and 8B illustrates another approach to the preferred embodiment; FIGS. 9A and 9B depicts another embodiment of the catheter having variable flexibility by virtue of channels for carrying iced saline; and FIGS. 10A, 10B, 10C, 10D and 10E depicts another embodiment of a variable flexibility catheter which permits the introduction of stiff wires of tensionable members. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 illustrates the typical configuration of a conventional left coronary guiding catheter in the aorta when engaged within the left main coronary artery during the performance of a left coronary artery 18 PTCA. (The guiding catheter has been drawn with a relatively large caliber for the purpose of clarity.) The aorta 10 includes an ascending portion 12 and a descending portion 14. The angioplasty dilation balloon 28 and intracoronary guide wire 25 have been included in FIG. 1 for the purpose of orientation. Although a left Judkin's configuration guiding catheter was selected for this, and subsequent illustrations, this discussion is not meant to be confined to this configuration alone. The concept of a variably compliant guiding catheter may be applied to all configurations of guiding catheters including the Judkin's, Sone's, Stertzer and Amplatz configurations. For the performance of an angioplasty of the right coronary artery 16, a guiding catheter with a different configuration must be employed. The concept of a variably flexible guiding catheter applies to these configurations as well. As described above, the performance of an angioplasty initially requires the introduction of a guiding catheter within a peripheral artery. By virtue of a guidewire (not shown) and the preshaped nature of guiding catheter 20 at its distal end 32, the catheter is manipulated up the descending aorta 14 and down the ascending aorta 12 to place the end 32 of the guiding catheter 20 within the coronary ostium thus permitting subsequent advancement of the angioplasty guidewire 25 and balloon catheter 28 within the diseased vessel. FIG. 2 illustrates a disadvantage of a guiding catheter of the prior art. The components depicted in FIG. 2 have been labeled with reference numerals corresponding to the components in FIG. 1. In FIG. 2 the dilation balloon 28 has been advanced to the region of stenosis 19. Because the resistance imparted by the lesion exceeded the compliance characteristics of the guiding catheter, however, further attempts to advance the balloon catheter resulted in disengagement of the guiding catheter 22 and prolapse of the balloon catheter. In this condition attempting to advance the balloon 28 only causes the guiding catheter to back out further, and the guidewire and inflation channel to prolapse within the ascending aorta, as shown generally by reference numeral 33. Disengagement of the guiding catheter from the coronary ostium just as the operator attempts to advance the angioplasty dilation balloon 28 across the stenosis represents one of the principal causes for failure during the course of an angioplasty procedure. The instability of the guiding catheter is believed to result from several causes. First, the catheter has intrinsic flexibility to accommodate introduction. Secondly, the material from which the catheter itself is manufactured (multiple layers of dacron webbing coated with plastic polymer) becomes more flexible as it warms to body temperature. Thirdly, the configuration of the catheter provides little or no resistance to the forces which cause it to back out. For example, as shown in FIG. 3, the application of pressure on the dilation balloon 28 for the purpose of advancing the dilation balloon across the region of stenosis increases the torque on bend 35 in guiding catheter 20, causing the angioplasty balloon catheter to prolapse in the ascending aorta precluding any further progress. FIG. 4 illustrates one embodiment of the guiding catheter 40 of my invention. In contrast to prior art devices, the guiding catheter includes means for varying the flexibility of the catheter in a manner selected by the operator. For the embodiment shown in FIG. 4, the variable flexibility is provided by a balloon 50 which extends along the exterior surface of housing 42. Balloon 50 is inflatable and deflatable as desired by the operator, for example, by use of a syringe connected to a communicating channel 52 (see FIG. 6) extending through or along the catheter from exterior of the patient to the balloon 50. As also shown in FIG. 4, balloon 50, when inflated to high pressure, adds substantially to the rigidity of the distal end of catheter 40. This enables the use of additional force to advance the dilation balloon 28 through the region of stenosis. Once the dilation balloon 28 has been advanced through the region of stenosis, the balloon 50 affixed to the guiding catheter is deflated, rendering the guiding catheter 40 substantially more flexible, and hence less likely to induce any intimal vascular damage. A pressure source is then applied to inflate the balloon 28 and thereby ablate the stenosis. My invention offers several advantages over conventional guiding catheters used in the performance of an angioplasty procedure. Present catheters, in an effort to reach a compromise between flexibility and rigidity, are generally stiff, and therefore substantially more difficult to engage within the ostium. The use of my guiding catheter with variable flexibility in its most flexible condition at the outset permits easier engagement within the coronary ostium. Once engaged, the relative inflexibility of my catheter enables it to remain engaged within the ostium in a more stable manner than conventional catheters. This stability precludes the need for multiple angioplasty catheters and exchange wires, with their associated disadvantages described above. Furthermore, the relatively inflexible catheter minimizes traumatic injury to the coronary ostium by minimizing the use of force. Disruption of the intima of the coronary ostium by conventional guiding catheters represents a well known complication of angioplasty procedures. This complication can result in a coronary occlusion, and hence, myocardial infarction. Finally, the compliance characteristics of this guiding catheter are not affected by "warming up" to body temperature. In the embodiment depicted in FIG. 4, the balloon 50 may be filled by means of a syringe at the extracorporeal end of the catheter. Typically, the balloon will be designed to tolerate pressure on the order of 10 atmospheres. Because the catheter itself need not be as rigid as conventional catheters, the walls of the housing 42 need not be as thick. Accordingly, the caliber of the catheter with balloon 50 deflated may be less than the caliber of conventional guiding catheters. This feature will permit insertion of the catheter within a smaller arteriotomy. Furthermore, by fabricating the channel 52 connecting the exterior balloon 50 to the syringe of relatively large caliber, changes in balloon tension may be accomplished rapidly. A further advantage of the catheter depicted in FIG. 4 is that the use of the catheter may preclude the normal requirement for two physicians. In the prior art two physicians were typically necessary, one to monitor the engagement of the guiding catheter, and one to advance the guidewire and balloon catheter. With the catheter of the depicted embodiment, a physician may advance the catheter with one hand while inflating and deflating the balloon 50 with the syringe in the other hand, thus increasing and decreasing the rigidity of the catheter as necessary to advance it. FIG. 5 illustrates the means by which the preferred embodiment of the catheter of my invention provides additional "back pressure" to oppose the pressures described in FIG. 3. The balloon is preshaped to conform to the configuration of the guiding catheter when engaged in the coronary artery. As indicated, the arc 55 of the balloon 50, when inflated, is more acute than the corresponding arc of the distal aspect of the guiding catheter 42. As the balloon 50 is inflated, the catheter will begin to assume the configuration of the preshaped balloon 50. This will result in enhanced "back pressure" and thus enhanced stability of the guiding catheter during advancement of the angioplasty dilation balloon catheter 30. FIG. 6 is an expanded view of the distal end of the catheter showing housing 42 and balloon 50 in further detail. A cross section of the catheter is also depicted. Communicating channel 52, also contained within the catheter, connects to balloon 50 through lumen 51 to allow pressurization. FIG. 7 is a cross section of the distal end of the catheter showing balloon 50. FIG. 6 also illustrates an optional feature of my catheter. In this embodiment a second external balloon 46 is provided which is coupled to communicating channel 44 by lumen 48. In the same manner as balloon 50, balloon 46 may be inflated from outside the patient. Secondary balloon 46 enables selective deflection of the distal end of catheter 40 to assist in positioning the catheter within the coronary artery. By placing the secondary balloon on catheter 40 at 90° rotation from the preshaped curve 49 (and from the orientation of balloon 50), the distal end of the catheter may be deflected anteriorly or posteriorly to aid subselective cannulization of the LAD and circumflex branches of the left coronary system. FIG. 8 illustrates another approach to bonding the balloon 50 to the catheter housing 42. In this embodiment, the balloon is composed of an elastic material that permits elongation of the balloon with inflation to high pressures. In this embodiment, the preshaped configuration of the balloon is less important than in the embodiment described in FIG. 5. Since the balloon is attached to the circumferential aspect of the distal end of the guiding catheter, and since the balloon elongates with progressive inflation, the application of enhanced inflation pressure will change the configuration of the guiding catheter, providing enhanced "back pressure." FIG. 9 illustrates another embodiment of my invention in which the stiffness of the catheter is imparted by the introduction of iced saline solution or other coolant. In this embodiment an additional tube 53 surrounds the interior channel 47 (through which the angioplasty dilation catheter is passed) to provide two or more openings 54, 56 between housing 42 and tube 53. Inner channel 53 is coupled to outer housing 42 at least at two locations 55 to thereby provide a first chamber 54 and a second chamber 56. By circulating iced saline into one of the chambers 54 and 56 and out the other, and/or by manufacturing housing 42 from material which is temperature sensitive, the rigidity of the catheter may be substantially increased as necessary. In another embodiment of my invention, the rigidity of the catheter can be enhanced by the insertion of relatively stiff wires through channels along the periphery of the catheter. This embodiment is shown in FIG. 10. As shown, the housing 42 includes several integral channels 43 to permit insertion of one or more relatively stiff wires 58 along the periphery of the catheter. By bending the wires into the desired configuration and then inserting them after the catheter has been properly positioned, the wires 58 will add to the stiffness of the catheter. As before, the chamber 47 for the dilation balloon catheter is disposed within housing 42. In a further embodiment of my invention, instead of using stiff wires, relatively flexible wires are positioned around the periphery of the housing 42 and then tension applied to them after the catheter is properly positioned to increase the rigidity of the catheter. In such an embodiment, wires 58 are affixed to the distal end of the catheter. Of course, it is not essential that individual pockets for the wires 58 be employed, rather a conventional housing may be chosen and the wires simply inserted within chamber 47. In other embodiments of my invention, other means for stiffening the catheter may also be employed. For example, wires 58 may be fabricated from memory alloys or bimetal thermocouples which are then heated or cooled to the desired temperature by circulation of fluid through the catheter. In such an embodiment, the wires will be relatively flexible at body temperature, and then caused to assume a desired shape by either being cooled to a lower temperature, or heated to a higher temperature. In still further embodiments of my catheter, the guiding catheter is fabricated from material having properties which change when subjected to light, ultrasound, radio frequency, magnetic fields or other penetrating forces such as electric current. A laser, ultrasound source, etc., is then employed once the catheter is properly positioned to increase its rigidity. The foregoing has been a description of the preferred embodiments of the invention. Although many specific details have been described, it should be understood that the description is only for the purposes of explaining the invention, and not limiting it. It should be further understood that the configuration of the catheter proposed herein is not limited to the left Jodkin's configuration alone. This configuration was selected for the purpose of illustration only. The scope of the invention may be ascertained from the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation of copending application Ser. No. 12/875,444, filed on Sep. 3, 2010, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/240,063, filed on Sep. 4, 2009, and under 35 U.S.C. §119(a) to Application No. 09169510.6, filed in European Patent Office on Sep. 4, 2009, all of which are hereby expressly incorporated by reference into the present application. TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to a catheter, such as urinary catheters, and in particular to catheters of a relatively short length, such as female catheters. BACKGROUND [0003] The present invention relates to a catheter for draining bodily fluids, e.g. from the bladder. Urinary catheters are e.g. used by a large group of persons for intermittent catheterization, which is a daily-life procedure, taking place several times a day. Typically catheters for intermittent catheterization are used by patients suffering from urinary incontinence or by disabled individuals like para- or tetraplegics. Using an intermittent catheter, the bladder may be drained through a natural or artificial urethra. Many catheters for intermittent catheterization are provided with a hydrophilic coating or the like, providing a smooth and slippery surface for safe and comfortable insertion in the urinary canal. [0004] To this end, catheters should preferably be designed to enable easy handling and introduction into the urethra, even for users having reduced dexterity. Further, in order to reduce the risk of e.g. urinary tract infections, the catheters should preferably be handled in a clean manner, without directly touching the insertable part of the catheter with the hands, in order to avoid contamination prior to use. [0005] Catheters, such as urinary catheters, are normally produced in large volumes, having standardized lengths and standardized connector designs. However, it is sometimes requested to have large connector ends, in particular for short, female catheters, in order to improve maneuverability. However, provision of large assortment of different catheters, having different connector lengths, connector designs, catheter lengths, etc, makes the production costly. Typically catheters are designed for one-time use and accordingly the costs for producing, packing and sterilizing a catheter is an important issue. There is therefore a need for a simple and cost-effective way of modifying a pre-produced standard catheter to various specific needs, such as improved gripping possibilities. [0006] An alternative approach to obtain improved usability of catheters is disclosed in US 2005/0070882, which discloses a urinary catheter with a cuff loosely arranged over the connector end. This loosely arranged cuff can be moved along the catheter, for use when handling the catheter. However, this approach requires a relatively skilled user, and is e.g. complicated to for users with reduced dexterity, and is also difficult to use with short catheters, such as female urinary catheters. [0007] Further, US 2007/0066963 discloses a catheter assembly comprising a detachable catheter handle, which is connected to the rearward end of the catheter before use, in order to provide an enlarged handle for easier manipulation. Still further, US 2006/0142737 discloses a catheter assembly, including a catheter with a long connector end, for improved manipulation. However, both these prior art solutions are related to relatively complex catheter products, which are difficult and expensive to produce. [0008] In other products the contamination problem of the handle portion has been addressed by providing a handle formed separately from the catheter for attachment to the catheter prior to the insertion. Unfortunately, handles which are separate from the catheter imply other problems both with respect to the manufacturing costs and with respect to handling of two separate components when attaching the handle to the catheter. In addition, separation of the catheter into two separate components implies an increased risk of contamination, in particular, if the handle part is reused. Furthermore, division of the catheter into a handle part separate from an insertable part does not solve the problems of complicated unpacking. [0009] In conclusion there is still a need for catheters, which may be designed for simple and clean use, even for users with a reduced dexterity, and which can be produced in a cost-efficient manner. SUMMARY OF THE INVENTION [0010] It is therefore an object of the present invention to provide a catheter, and a method of producing such a catheter, which at least alleviates the above-discussed problems. [0011] This object is obtained by means of a catheter and a method of producing in accordance with the appended claims. [0012] According to a first aspect of the invention there is provided a catheter, and preferably a urinary catheter, comprising an elongate shaft with a catheter insertion end and a flared connector connected to the elongated shaft opposite to the catheter insertion end, the flared connector forming a catheter connector end; and a gripping sleeve being fixedly connected to said flared connector, and arranged to enclose at least a part of, and preferably essentially the whole, flared connector, apart from the catheter connector end. [0013] By “fixedly connected” is in this context to understand a connection which is not intended to be opened during normal use. It does not necessarily mean that the fixedly connected parts may not be separated, but that the connection is strong enough to ensure that such separation does not occur during normal use. The fixed connection can be obtained in various ways, such as by friction fit, adhesion, mechanical interlocking and the like. [0014] Hereby, it becomes possible to produce large series of catheters having standardized lengths and standardized flared connectors. The connector is preferably a relatively short conical connector part e.g. for connecting the catheter to elongate tubes or drainage containers for collecting urine. The connector also serves as a manipulation aid, and by gripping the connector, the catheter may be manipulated and inserted into the urinary canal (urethra). [0015] Thus, the catheter without any gripping sleeve in itself is a catheter which is adequate for many use situations. [0016] However, for customization, and simple production of other types of catheter products, the same, standard catheter may be used, and be completed with a gripping sleeve. Hereby, an extended and enlarged aggregate connector is provided. Such an enlarged gripping portion is highly advantageous in many situations, such as in products to be used by users with reduced dexterity, short catheters, where other types of insertion aids are difficult to use, etc. Thus, a catheter according to the present invention is particularly advantageous for short catheters, used e.g. by females, children or persons with an artificial urinary canal. In one embodiment of the invention the catheter is adapted to fit the female urethra, i.e. it may be provided in a length in the range of 50-200 mm, such as 130-180 mm, such as in a length in the size of 150 mm. [0017] Further, the sleeve does preferably not extend past the rearward end of the catheter. Hereby, the ordinary handling of the catheter, e.g. connecting it to additional tubing or a urine collection bag, is not in any way affected. [0018] By means of the present invention, it is possible to use the same production equipment for a large variety of different catheter products, which makes the production very cost-efficient. Further, it becomes possible to react quickly to market demands, and introduce specialized catheters for various types of specific use. [0019] Preferably the gripping sleeve has an axial length significantly longer than the axial length of the flared connector. For example, the gripping sleeve may have an axial length which is at least 25% longer than the axial length of the flared connector, and preferably at least 50% longer. It is also preferred that the gripping sleeve has an axial length of at least 4 cm, and preferably at least 5 cm. [0020] The catheter may be any type of catheter, but in a preferred embodiment the catheter is a urinary catheter. [0021] The gripping sleeve is preferably connected to the flared connector end by means of a friction fit (i.e. press fit) or mechanical interlocking. This way of connecting the gripping sleeve makes the production very simple and cost-efficient. Alternatively or additionally, the gripping sleeve may be connected to the flared connector by means of at least one of welding and adhesion. [0022] In order to further enhance the attachment of the gripping sleeve to the flared connector, the flared connector is preferably provided with an outwardly facing corrugation, and the gripping sleeve is preferably provided with a corresponding inwardly facing corrugation. [0023] The outer surface of the gripping sleeve may be provided with various means for improve the gripping and handling. Thus, the gripping sleeve may be ergonomically shaped to make it easier to manipulate, especially for persons with reduced dexterity. For example, the gripping sleeve may be provided with an outwardly facing corrugation. The gripping sleeve may also be provided with outwardly protruding gripping means, such as wings. Other types of protruding parts, such as grooves, rugged surfaces, finger holes, etc, are also feasible. [0024] The invention is particularly useful for hydrophilic catheters, i.e. catheters having a hydrophilic surface coating on part or the whole of the exterior surface of the elongate shaft. [0025] Further, it is preferred that the flared connector comprises an outwardly protruding flange in the vicinity of the catheter connector end, said flange providing an abutment for the gripping sleeve. Hereby, the attachment of the gripping sleeve is improved, and further, it is ensured that the gripping sleeve does not protrude past the end of the flared connector. [0026] According to a further aspect of the invention, there is provided a method of producing a customized catheter, and preferably a urinary catheter, comprising the steps of: [0027] providing a base catheter comprising an elongate shaft and a flared connector with a catheter connector end connected to one end of said elongate shaft; and [0028] arranging a customizable gripping sleeve over said flared connector, to enclose at leat a part of, and preferably essentially the whole, flared connector, apart from the catheter connector end, and fixedly connecting the gripping sleeve to said flared connector. [0029] Hereby, similar advantages as discussed above with reference to the first aspect of the invention are obtained. [0030] The method further preferably comprises the step of selecting a suitable gripping sleeve among a plurality of available gripping sleeves. Preferably, a plurality of different gripping sleeves are provided, and used on common base catheters to form a plurality of different catheters. Hereby, it becomes possible to provide a number of various gripping sleeve, corresponding to a number of different catheters, and to produce said different catheters in the same line of manufacturing. [0031] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS [0032] For exemplifying purposes, the invention will be described in closer detail in the following with reference to embodiments thereof illustrated in the attached drawings, wherein: [0033] FIG. 1 illustrates a catheter in accordance with an embodiment of the present invention; [0034] FIG. 2 illustrates a part of the catheter of FIG. 1 , partially in section; and [0035] FIG. 3 illustrates an intermediate step in the assembly of the catheter of FIG. 1 . DESCRIPTION OF PREFERRED EMBODIMENTS [0036] In the following detailed description preferred embodiments of the invention will be described. However, it is to be understood that features of the different embodiments are exchangeable between the embodiments and may be combined in different ways, unless anything else is specifically indicated. It may also be noted that, for the sake of clarity, the dimensions of certain components illustrated in the drawings may differ from the corresponding dimensions in real-life implementations of the invention, e.g. the length of the catheter, etc. [0037] Catheters may be used for many different purposes, and for insertion into various types of body-cavities. However, the following discussion is in particular concerned with the preferred field of use, hydrophilic urinary catheters, even though the invention is not limited to this particular type of catheters. [0038] A catheter 1 as illustrated in the drawings, e.g. in FIG. 3 , comprises a flared rearward portion, forming a flared connector 2 , and an elongated shaft 3 , connected to the flared connector 2 , and in the opposite end having a catheter insertion end 31 . The flared connector 2 forms a catheter connector end 21 . [0039] An open-ended internal lumen (not shown) extends from the catheter connector end 21 to a drainage aperture 32 in a rounded tip 33 of the elongate tube 3 . [0040] The flared connector 2 may function as a connector of the catheter 1 , being connectable to other devices, such as a urine collection bag, a drainage tube or the like. It may have any size and form, forming a flared extension in relation to the elongate shaft, as is per se well known in the art. Further, the flared connector 2 may be connected to the elongate shaft 3 by means of welding, adhesion or the like, or form an integrated part of the elongate shaft. [0041] At least a part of the elongate shaft 3 forms an insertable length to be inserted through a body opening of the user, such as the urethra in case of a urinary catheter. By insertable length is normally, in the context of a hydrophilic catheter, meant that length of the elongate shaft 3 which is coated with a hydrophilic material, for example PVP, and which is insertable into the urethra of the patient. Typically, this will be 50-140 mm for a female patient and 200-350 mm for a male patient. Even though PVP is the preferred hydrophilic material, other hydrophilic materials may be used, such as hydrophilic polymers selected from polyvinyl compounds, polysaccharides, polyurethanes, polyacrylates or copolymers of vinyl compounds and acrylates or anhydrides, especially polyethyleneoxide, polyvinyl-pyrrolidone, heparin, dextran, xanthan gum, polyvinyl alcohol, hydroxy propyl cellulose, methyl cellulose, copolymer of vinylpyrrolidone and hydroxy ethylmethyl acrylate or copolymer of polymethylvinyl ether and maleinic acid anyhydride. The coating may also comprise an osmolality-increasing compound, as is e.g. taught in EP 0 217 771 [0042] In addition, the catheter comprises a gripping sleeve 4 surrounding and being fixedly connected to the flared connector 2 , and arranged to enclose essentially the whole flared connector, apart from the catheter connector end 21 . [0043] The gripping sleeve 4 preferably has an axial length significantly longer than the axial length of the flared connector 2 . [0044] The gripping sleeve is preferably connected to the flared connector end by means of a friction fit. Alternatively or additionally, the gripping sleeve may be connected to the flared connector by means of at least one of welding and adhesion. In order to further enhance the attachment of the gripping sleeve to the flared connector, the flared connector 2 is preferably provided with an outwardly facing corrugation 22 , and the gripping sleeve 4 is preferably provided with a corresponding inwardly facing corrugation 41 . Further, it is preferred that the flared connector 2 comprises an outwardly protruding flange 23 in the vicinity of the catheter connector end, providing an abutment for the gripping sleeve 4 . [0045] The gripping sleeve is a tubular part, with a first opening with an inward diameter preferably essentially corresponding with the corresponding external diameter of the flared connector, and a second opening with an inward diameter preferably corresponding with the corresponding external diameter of the elongate shaft. The gripping sleeve preferably has a cylindrical shape, and it could be circular or non-circular in a cross-sectional view. [0046] The outer surface of the gripping sleeve 4 may be provided with various means for improve the gripping and handling. For example, the gripping sleeve may be provided with an outwardly facing corrugation 42 . The gripping sleeve may also be provided with outwardly protruding gripping means, such as wings (not shown). [0047] The catheter components can be made from a large number of feasible materials, as is per se well known in the art. The elongate shaft, the flared connector and the gripping sleeve may further be made of the same material, or by two or more different materials. In the latter case, the parts may be made from materials with different characteristics towards softness and/or rigidity. The gripping sleeve may e.g. be made from a low frictional material, or it may have a surface coating preventing sliding between the fingers of the user, or it may have a surface pattern facilitating a better grip. The gripping sleeve could be made from a material which is rigid compared to the insertable part of the catheter. [0048] The various catheter parts, or at least a part of one or several of said parts, could be made from a thermoplastic elastomer or other thermoplastic materials, or from a curable elastomer material, or from any mixture or combination thereof. Thermoplastic elastomer materials may comprise materials like polyurethane elastomers, polyetherblockamide elastomers, polyester elastomers, polyolefin elastomers and polystyrene elastomers and SEBS. Other thermoplastic materials may comprise PVC, e.g. plasticized PVC, polyethylene homo- or co-polymers, polypropylene homo- or co-polymers, polyamide types, polyester types, fluorine-containing thermoplastic materials such as fluorine-containing elastomers among others. Curable elastomer material may comprise silicone elastomers and curable polyurethane elastomers among others. Latex rubbers and other rubbers are also feasible. [0049] Each of the parts can be made e.g. by extrusion, injection moulding, blow moulding etc. [0050] A method of manufacturing the above-discussed catheter preferably comprises the steps of first producing a base catheter comprising an elongate shaft and a flared connector with a catheter connector end connected to one end of said elongate shaft, as is per se known in the art. Subsequently, the gripping sleeve is arranged over the flared connector, to enclose essentially the whole flared connector, apart from the catheter connector end, and fixedly connecting the gripping sleeve to said flared connector. This is illustrated in FIG. 3 . [0051] The invention has now been described by means of preferred embodiments. However, many further variations are possible. For example, the griping sleeve may be attached to the flared connector in other ways, such as by means of mechanical interlocking, the gripping sleeve may be provided with various forms of external gripping means, etc. Such and other obvious modifications must be considered to be within the scope of the present invention, as it is defined by the appended claims. It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting to the claim. The word “comprising” does not exclude the presence of other elements or steps than those listed in the claim. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. Further, a single unit may perform the functions of several means recited in the claims.

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CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of provisional application Ser. No. 61/189,337 filed Aug. 18, 2008 as well as provisional application Ser. No. 61/199,249 filed Nov. 15, 2008. The forgoing provisional applications are hereby incorporated by reference in their entirety. FIELD OF INVENTION [0002] The present invention is in the field of furniture, particularly outdoor furniture. DEFINITIONS [0003] Although water is the most suitable liquid for use in conjunction with the present article, other liquids may be used. Water is cited herein as exemplary of any liquid with which a reservoir in the article may be filled. [0004] Although the article of the present invention may be used most commonly to cool a person with relatively cool water, the article may alternatively be used to warm a person with relatively warm water. Cool is used as an example herein for either cool or warm. [0005] The description of a person sitting on the article of this invention is equivalent to describing a person reclining or lying on the article. BACKGROUND AND PRIOR ART [0006] It is known that immersing parts of a person's body in water can have a cooling, warming or otherwise comforting effect on the person. It is desirable and known to support a person such as in a chair while that person is immersed in water to eliminate the need for swimming or other exertion. Chairs that float or attach to a side of a pool of water are known. U.S. Pat. No. D298,055 teaches a “Suntanning Pool” that contains a molded chair shape to support a person within a container of water in which the container and chair shape are a unitary piece. U.S. Pat. No. 3,969,776 is an example of an open rectangular box or receptacle that contains a bath of water and which has a reclining wall at one end to support the torso of a reclining human body immersed in the open, rectangular box of water. [0007] It is known that molded plastic can be shaped to conform to the shape of the human body both to support and immerse a body in water, such as in the molded baby baths of U.S. Pat. Nos. D299,741 and D469,860, and 4,561,135. U.S. Pat. No. 4,466,141 teaches a molded plastic hydrothermal treatment enclosure that serves a similar purpose for supporting a person's body immersed in water. U.S. Pat. Nos. 3,528,111, 4,150,445, 3,346,885, 4,160,292, and 4,521,926 similarly teach bath chairs. Some Jacuzzis contain molded shapes to support in a sitting position a person immersed in a pool of water. [0008] To provide cooling to a human body while conserving space such as on small patios, to reduce the chair's strength requirements, and to improve control of water temperature it is desirable to immerse at least portions of a person's body in a minimal volume and weight of water. The previously mentioned immersed chairs are useful for immersing a person in water and supporting the person, but require large amounts of water. They are not portable or convenient to fill or use or to control the temperature of the water, and do not contain portable means for dispensing, flowing, and collecting water as in the present invention. OBJECTIVES [0009] It is an objective of the present invention to provide an article that is suitable for cooling a person with a minimal amount of water. It is particularly an objective to provide such an article for portable outdoor use. It is another objective of the present invention to provide such an article to provide cooling while the person is seated or reclining comfortably without the expense of integral supporting chair structures. Further objectives are to provide the said article with circulating cooling water and to provide adjustments to the extent to which the person is immersed in water within the article. BRIEF SUMMARY OF THE INVENTION [0010] The invention or article is a chair or a mat laid on a chair, and particularly on a reclining chair or lounger. The chair or mat laid on a chair contains a reservoir of water, herein referred to as a trough, to collect water near the feet of a person sitting on the article or a hip reservoir of water to at least partially immerse the buttocks of a person sitting on the article. The article preferably contains both a trough and a hip reservoir which may communicate with each other above a prescribed elevation. The water is contained in the trough between walls including the wall of the article that supports the lower legs of the person sitting on the article, herein referred to as the calf wall, an end wall near the foot of the article and two side walls joined to or proximate the calf and end walls. The trough may take the form of a concave dished shape which retains or collects water cascading from the hip reservoir to the trough. The water is contained in the hip reservoir between walls including the wall of the article that supports the upper legs of the person sitting on the article, herein referred to as the thigh wall, the wall that supports the back of the person sitting on the article, herein referred to as the back wall, and two side walls joined to or proximate the thigh wall and back wall. The hip reservoir may take the form of a concave, dished shape seating area which retains or collects water cascading from the back wall or head area of the article to the hip reservoir. [0011] The article has conduits and pumping means for directly or indirectly pumping water from the trough to the hip reservoir. The article optionally has a head rest or pillow and internal channels to direct the flow of water onto the person sitting on the article. The article also optionally has means for adjusting the water level in the hip reservoir, in the trough, or in both reservoirs. The article can optionally be at least partially covered with a water impervious membrane to keep the person sitting on the membrane above the article dry while being cooled by the flowing or still water. The article in the form of a chair optionally has legs and/or wheels, steps, alternate foot rests, an internal hammock or body support, and a head rest or pillow. The chair also optionally has means for adjusting the water level in the hip reservoir, in the foot reservoir, or in both reservoirs. [0012] The article is made for use with the recirculation of less than 20 gallons of recirculating water, preferably less than 6 gallons of recirculating water and most preferably less than 3 gallons of recirculating water. The article weighs less than 100 pounds, preferably weighs less than 20 pounds and most preferably weighs less than 10 pounds. BRIEF DESCRIPTION OF DRAWINGS [0013] FIG. 1 is a side view of the present invention as a chair. [0014] FIG. 2 is a perspective view of the present invention as a chair. [0015] FIG. 3 is a side view of the present invention as a mat. [0016] FIG. 4 is a perspective view of the present invention as a mat. [0017] FIG. 5 is a plan view of the top surface of the present invention as a mat when the mat lies straight. DETAILED DESCRIPTION OF THE INVENTION [0018] The following detailed description discloses various exemplary embodiments and features of the invention. These exemplary embodiments and features are not meant to be limiting. [0019] Referring to FIG. 1 , chair 1 is provided that contains foot reservoir 2 and hip reservoir 3 which can alternatively or collectively be filled with water to cool a person sitting in the chair. Water in the foot reservoir is contained by the end wall 4 , calf wall 5 , and two side walls 6 up to the maximum fill edge 7 . Water in the hip reservoir is contained by thigh wall 8 , back wall 9 , and two side walls 10 up to the maximum fill edge 7 . Back wall 9 extends from the hip reservoir to the head of the chair to support the back and head of a person sitting in the chair. The back wall is bounded by two side walls or wings to front edge 11 and top edge 12 . The chair may optionally be equipped with head rest 13 attached to the chair by string or attachment 14 wherein the length of attachment 14 is adjustable to adjust the position of the head rest. The chair may also be equipped with front or back legs or wheels. An example of a back leg 15 is shown. [0020] The lowest point within the hip reservoir is at a higher elevation than the lowest point within the foot reservoir. The foot and hip reservoirs may share common side walls such that side walls 6 and 10 are in the same plane and rise to the same elevation or maximum fill edge 7 . The fill edge is horizontal. [0021] The walls of the chair may be constructed of any of various materials that are nontoxic, water and sun resistant, and impervious to water such as urethane, nylon, or other plastics or resins. Plastics and resins are preferred over metals or ceramics. [0022] The chair of the present invention is optionally equipped with conduits 16 which communicate with the foot reservoir at one end and with the upper surface of the back wall or hip reservoir at the other end and with a pumping means 17 , which may be a water pump. The conduits 16 and pumping means pump water from the foot reservoir to the hip reservoir. In FIG. 1 the conduit is fastened to or is part of the lower surfaces of the chair and recirculates water from the foot reservoir to a position above the shoulders of the person sitting in the chair, from where the water cascades to the hip reservoir. The pumping and filling of the hip reservoir causes the water to overflow from the hip reservoir into the foot reservoir. The water level of the foot reservoir may be maintained at the same as or at a lower level than in the hip reservoir. The water level in both reservoirs may be maintained up to the maximum fill edge. The chair may optionally contain a conduit 18 illustrated with dashed lines. The conduit 18 allows the hip reservoir and foot reservoir to communicate with each other at a lower elevation than via the overflow elevation of the lowest portion of the intersection of the calf wall and thigh wall. By opening a plug or valve, not shown, in conduit 18 the water level in the hip reservoir can overflow to the foot reservoir through the conduit 18 and causing the water level to overflow to the foot reservoir at a lower level than when the plug or valve is closed. [0023] Step 19 is molded into the calf wall to facilitate entry to and exit from the chair. [0024] The upper end of conduit 16 may alternatively inject water into the head rest 13 . In this embodiment the heat rest contains either conduits or porous elements to convey water from the inlet conduit 16 to parts of the surface of the head rest from which the water exits the head rest and cascades to the hip reservoir. In this embodiment head rest may optionally be rotated so as to direct the flow of cascading water from the head rest toward the front or alternatively toward the back of the torso of the person sitting in the chair. This head rest adjustment gives the person sitting in the chair control over which parts of his head and torso are wetted and cooled by the cascading water. [0025] In another embodiment the chair 1 is fitted with an internal hammock or highly permeable pad, not shown, as an internal support which lays above the back, thigh and calf walls and on which the person sitting in the chair rests. The internal support supports the person sitting in the chair above the respective back, thigh, and calf walls so that cooling water may flow between the person and the respective walls as to cool the person effectively. In a first internal support embodiment the top surface or surface of the internal support contacting the person's body is permeable to water, such as a netting material, such that the person is cooled by direct contact with water. In a second internal support embodiment the support separates the person from the water by a water impervious membrane such that the person is cooled indirectly by the water without the person being wetted or needing appropriate attire for being wet. The internal support may contain longitudinal channels running from the upper end of conduit 16 to the hip reservoir, to the foot reservoir or to the lower end of the conduit 16 . The walls of the channels may be rigid such that the channels are not closed by the person's weight so that water may flow though the channels unimpeded. Alternatively, the first and second internal support embodiments may be combined such that, for example, the upper portion of the hammock is impervious to water and the lower portions are pervious to water such that the person may be kept dry in the upper portions and the person may be wetted in the lower portions. [0026] The chair may optionally include multiple foot rests, arm rests, a movable tray or book support, and/or steps for entering and exiting the chair. [0027] Referring to FIG. 2 , a perspective view is illustrated in which all items corresponding to FIG. 1 have the same numbering as in FIG. 1 . A step 19 , illustrated with dotted lines, is molded into the calf wall to facilitate entry to and exit from the chair. Conduits and pumping means are not shown. [0028] Referring to FIG. 3 , mat 1 is provided that rests on a lounge chair, not shown, and contains trough 2 and hip reservoir 3 which can alternatively or preferably collectively be filled with water to cool a person sitting on the mat. Water in the trough is contained by the end wall 4 , calf wall 5 , and two side walls 6 up to the maximum fill edge 7 . Water in the hip reservoir is contained by thigh wall 8 , back wall 9 , and two side walls 10 up to the maximum fill edge 11 . Back wall 9 extends from the hip reservoir to the head of the chair to support the back and head of a person sitting on the mat. The mat is preferably equipped with head rest 12 . The head rest preferably contains manifold or header 13 and one or more orifices or spouts 14 . Water is preferably pumped into the header, which distributes the water to and through multiple spouts to cascade over the head or shoulders and over the upper portions of the body of the person sitting on the mat. [0029] The walls of the mat may be constructed of any of various materials that are nontoxic, water and sun resistant, impervious to water and flexible such as foam rubber or other foam products or as thin sheets of plastic or resin. Foam is preferred. One such suitable material is sold under the trademark of Aqua Cell™ by Spongex LLC of the USA. [0030] The mat of the present invention optionally contains at least one conduit 15 , shown as a wide line, which communicates with the trough at one end and with the upper surface of the back wall, with the hip reservoir, or preferably with the head rest at the other end and contains pumping means 17 which may be a water pump located within the trough. Water is preferably pumped via the pumping means and conduit 15 from the trough to the header within the head rest, from which header the water flows through spouts to the head rest or to the upper surface of the back wall or to the hip reservoir. The conduit 15 may be an enclosed channel within the mat or may be a tube separate from the mat or may be a tube within a laterally enclosed or partially exposed channel in the mat. Water directly or indirectly entering the hip reservoir from the recirculation pump and conduit overflows from the hip reservoir into the trough. The water level in the trough and hip reservoir may be maintained up to their respective maximum fill edges 7 and 11 . The water level of the trough may be maintained at the same level as or at a lower elevation than the water level in the hip reservoir. [0031] In the invention's simplest embodiment, water overflows from the hip reservoir into the trough at the lowest point at which the upper surfaces of the calf wall and thigh wall intersect. The weight of the legs of the person sitting on the mat may compress the foam and locally depress the elevation of that intersection to define where that lowest point in the intersection is. When the mat is laid on a cushioned or sling chair the water will overflow around the where the person's legs depress the elevation of that intersection. When the mat is laid on a chair that is inflexible such as a chair made of wood or metal in which the transverse cross section of that intersection is essentially flat, the mat may have small side walls, not shown, to either side of the intersection to cause the water to flow over that intersection into the trough rather than spill to either side of the mat. [0032] The mat may optionally be equipped with a tube 16 illustrated with dotted lines which allows the hip reservoir and trough to communicate with each other at a lower elevation than via the overflow elevation of the lowest portion of the intersection of the calf wall and thigh wall. Tube 16 may contain a plug or valve, not shown, to open or close communication between the hip reservoir and the trough via tube 16 . When the plug or valve in tube 16 is open, water in the hip reservoir can overflow to the trough through tube 16 , causing the water level to drain from the hip reservoir at a lower hip reservoir fill height than when the plug or valve is closed. Alternatively, by constructing tube 16 of flexible tubing the highest elevation of tube 16 may be manually adjusted to cause water to overflow into the trough at that highest elevation of tube 16 . In this alternative use, a plug or valve in tube 16 may be unnecessary. In another embodiment, tube 16 may be operated as a siphon to further lower the water level in the hip reservoir. Tube 16 is located to the side of the chair the pad rests on to avoid interference between tube 16 and the supporting chair. [0033] Referring to FIG. 4 , a perspective view is illustrated in which all items corresponding to FIG. 3 have the same numbering as in FIG. 3 . The header, conduits and pumping means are not shown in FIG. 4 . [0034] Referring to FIG. 5 , in a preferred embodiment, portions of the upper surface of mat 1 extending from the head end 30 to the foot end 31 is fitted with protrusions separated by channels to cause water to flow between the mat and the person sitting on the mat. Protrusions 32 , all shown as shaded areas in FIG. 5 , are separated from each other by longitudinal channels 33 and transverse channels 34 . Longitudinally successive sections of longitudinal channels are transversely offset from each other to create turbulence in the water flowing along the longitudinal channels. The turbulence provides additional heat transfer between the water and the person sitting on the mat and has the effect of vibrating or massaging the person. For example, the protrusions separating the channels are 0.5 inches wide, 4 inches long and protrude 0.5 inches above the upper surface of the mat, and the longitudinal and transverse channels are 0.3 inches wide. [0035] The mat may optionally be equipped with upwardly protruding walls, not shown, along the lateral edges of the upper surface of the mat to contain water from spilling over the sides of the mat. [0036] The mat may optionally be equipped with a water impervious membrane, not shown, lying on the upper surface and on the protrusions of the mat and separating at least the upper portions of the person sitting on the mat from the water flowing through the channels 33 and 34 such that the person is cooled indirectly by the water without the person being wet or needing appropriate attire for being wet. [0037] The mat may optionally include multiple foot rests, arm rests, cup holders, a movable tray or a book support. [0038] Although the present invention has been described in terms of certain preferred embodiments, various features of separate embodiments can be combined to form additional embodiments not expressly described. Moreover, other embodiments apparent to those of ordinary skill in the art after reading this disclosure are also within the scope of this invention. Furthermore, not all of the features, aspects and advantages are necessarily required to practice the present invention. Thus, while the above detailed description has shown, described, and pointed out novel features of the invention as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the apparatus or process illustrated may be made by those of ordinary skill in the technology without departing from the spirit of the invention. The inventions may be embodied in other specific forms not explicitly described herein. The embodiments described above are to be considered in all respects as illustrative only and not restrictive in any manner. Thus, scope of the invention is indicated by the following claims rather than by the foregoing description.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. Non-Provisional application Ser. No. 13/958,255 filed Aug. 2, 2013, which is a continuation of U.S. Non-Provisional application Ser. No. 12/809,223, filed Jun. 18, 2010, now U.S. Pat. No. 8,500,692, which is a 35 U.S.C. §371 national stage entry of PCT/IL2008/001650, which has an international filing date of Dec. 21, 2008 and claims priority to U.S. Provisional Patent Application No. 61/065,142, filed on Dec. 8,2008 and U.S. Provisional Patent Application No. 61/008,693, filed on Dec. 21, 2007. The present application incorporates herein by reference the contents of each of the above-referenced applications in their entireties. FIELD [0002] Devices and methods for sustained delivery of fluids and/or continuous monitoring of body analyte are described herein. More particularly, a portable infusion, patch-like pump, adherable to the skin that can also continuously monitor body analytes is described. Also provided herein is a fluid dispensing and/or body analyte monitoring device having a power source and components for energy conservation. BACKGROUND [0003] Medical treatment of certain illnesses requires continuous drug infusion into various body compartments, such as subcutaneous and intravenous injections. Diabetes mellitus (DM) patients, for example, require the administration of varying amounts of insulin throughout the day to control their blood glucose levels. In recent years, ambulatory portable insulin infusion pumps have emerged as a superior alternative to multiple daily syringe injections of insulin for Type 1 (Diabetes Medicine 2006; 23(2):141-7) and Type 2 (Diabetes Metab 2007 Apr. 30, Diabetes Obes Metab 2007 Jun. 26) diabetes patients. These pumps, which deliver insulin at a continuous basal rate, as well as in bolus volumes, were developed to liberate patients from repeated self-administered injections and allow them to maintain a near-normal daily routine. Both basal and bolus volumes must be delivered in precise doses according to individual prescription, since an overdose or underdose of insulin could be fatal. [0004] The first generation of portable insulin pumps refers to a “pager-like” device with a reservoir contained within a housing. A long tube is provided for delivering insulin from the pump attached to a patient's belt to a remote insertion site. The reservoir, delivery tube and the hypodermic cannula altogether constitute an “infusion set”. The recommended time for replacing an infusion set is every 2-3 days to avoid local infection at the cannula insertion site. Most users, however, extend this period until the reservoir is empty, sometimes up to 7 days. Examples of such devices are disclosed in U.S. Pat. Nos. 3,631,847, 3,771,694, 4,657,486, and 4,544,369. These devices represent a significant improvement over multiple daily injections but suffer from major drawbacks, including large size, heavy weight and long tubing. The size and weight of these devices is primarily attributable to the size and number of batteries (i.e., AA or AAA-type) employed in the devices for supplying the required high energy demand of the motor, screen, alarms, and other components which consume energy. [0005] These bulky devices with long tubes are uncomfortable and are rejected by the majority of users because they interfere with daily activities, e.g., walking, running, and sports. To avoid the tubing limitations, a second generation concept was proposed, directed to a remote controlled skin adherable device with a housing having a bottom surface adapted to be in contact with the patient's skin, with a reservoir contained within the housing, and with an injection needle adapted for fluid communication with the reservoir. These skin adherable devices are designed for replacement every 2-3 days similarly to the currently available pump infusion sets. Most patients, however, prefer to extend this period until the reservoir is empty. This concept is discussed in U.S. Pat. Nos. 4,498,843, 5,957,895, 6,589,229, 6,740,059, 6,723,072, and 6,485,461. [0006] These second generation skin adherable devices still have at least two major drawbacks: The entire device should be disposed every 3 days including all expensive components (e.g., electronics, driving mechanism). The device is still heavy and bulky, which is exceptionally important drawback because the device should be directly attached to the patient's skin and remain in place for at least 3 days. The main reason for the large size and heavy weight is the size and number of batteries (e.g., AA, AAA or button-type) that supply energy to the motor, alarms, and maintain a communication link between the skin adherable device and the remote control unit. For example, the voltage required by many of the low voltage controllers and motors is 3 Volts, while the output of the batteries is less than 1.6 Volts. [0009] In U.S. Pat. No. 7,144,384 to Gorman et al., assigned to Insulet Corporation, a skin adherable device is disclosed. The patent discusses that a large portion of the device is occupied by four silver-oxide button batteries positioned perpendicular to the longitudinal axis of the device, making the device thick (18 mm) and bulky. Moreover, due to high energy consumption, such batteries typically last only 3 days, forcing the user to dispose of the entire device every 3 days. [0010] A third generation skin adherable device was devised to increase patient customization. An example of such a device is described in the co-owned, co-pending U.S. patent application Ser. No. 11/397,115 and International Patent Application No. PCT/IL06/001276. This third generation device contains a remote control unit and a skin adherable patch unit (also referred to as “dispensing patch unit”) that includes two parts: Reusable part—containing the metering portion, electronics, and other relatively expensive components. Disposable part—containing the reservoir and in some embodiments, batteries. A tube delivers the fluid from the reservoir to an exit port that contains a connecting lumen. [0013] This concept provides a cost-effective skin adherable device and allows for a diversity of features, including various reservoir sizes and various needle and cannula types. [0014] In the co-owned, co-pending U.S. patent application Ser. No. 12/004,837 and International Patent Application No. PCT/IL2007/001578, a fourth generation device is disclosed. This device is configured as a patch that can be disconnected and reconnected to a skin adherable cradle unit. The patch can be remotely controlled or can be operated by buttons that are located on the patch as disclosed in the co-pending, co-owned U.S. Provisional Patent Application No. 60/961,527. In this configuration, the user can deliver a required bolus dose by repetitive button pressing according to a predetermined dose per button press (“Bolus buttons”). [0015] The co-owned, co-pending U.S. patent application Ser. No. 11/706,606, the disclosure of which is incorporated herein by reference in its entirety, discloses a device that contains a dispensing patch unit and an analyte sensing means (e.g., sensor). This dual function device has the same configuration that was outlined above and can also be disconnected and reconnected at the patient's discretion. [0016] Both third and fourth generation devices may use a single, small-sized battery. An example of such a battery is a zinc-air battery, as disclosed in co-pending, co-owned U.S. Provisional Application No. 60/961,484. These batteries have many advantages, including low weight, small size, low cost, long shelf lives, high specific energy and high stability. However, such batteries have a limited amount of stored energy of about 0.3 W·h, while a single use zinc-carbon AA battery has stored energy of about 1.2 W·h AAA batteries, however, are more than ten times larger and heavier than zinc-air batteries. Therefore, in order to enable employment of a small size power source, which has limited stored energy, the energy consumption of the electrical components of the dispensing patch should be reduced, especially the energy consumption of the motor, which is the primary energy consumer. [0017] The motor requires a substantial amount of energy for its operation: a current of about 500 mA and voltage of about 3 Volts, i.e., 1.5 Watts of electrical power. The power output of a zinc-air battery provides an electrical current of 10 mA and voltage of about 1.2 Volts, i.e., 0.012 Watts of electrical power. To provide the 3 Volts required by the motor and the CPU from a battery output of 1.2 Volts, a DC-DC step-up converter is used. The current requirements are provided by a pulsed power method, i.e., accumulating energy over a relatively long period of time and releasing it very quickly, thereby increasing the instantaneously supplied power. As such, the pulsed method is based on generating periodic pulses of high power. [0018] It is, therefore, essential that the pulses' parameters (e.g., duty cycle, pulse duration, width and amplitude) comply with the electromechanical properties of the motor (e.g., load, torque friction). This can be carried out, for example, by changing pulse duration according to the load on the motor, as discussed in U.S. Pat. No. 5,774,426 to Mai Xuan Tu et al. The electrical load on the motor is measured to determined missed steps of the motor (i.e., momentary failure of the motor). The energy supply to the motor is increased upon detection of the missed steps. Unfortunately, this invention is applicable only to a single phase step motor and it may require several iterations (including additional missed steps of the motor and loss of energy) prior to actual supplying energy sufficient to rotate the motor. [0019] Another method to control the motor electronically is based on changing the duty cycle according to energy stored in an implanted infusion device power source, as discussed in U.S. Pat. No. 7,122,026 to Rogers et al. The duty cycle is increased to compensate for power source depletion. Yet, some energy supply devices (e.g., zinc-air batteries) maintain nearly constant power supply even when depleted. Thus, applying this method would result in unnecessary energy consumption. This method also ignores other mechanical factors associated with the motor's operation, such as inertia and load. SUMMARY [0020] A device for the delivery of fluid to a patient's body is provided. The device may include a miniature and thin portable programmable fluid dispensing unit. The dispensing unit may be a small, low cost, portable dispensing patch unit which is adherable to the patient's body. The dispensing unit may include two-parts: a disposable part and a reusable part. A power source may be incorporated into the infusion device and may include without limitation a single, small-sized, button battery. [0021] In some embodiments, the dispensing unit includes a driving mechanism and pumping mechanism to dispense fluid from a reservoir to an outlet port that can be connected to a cannula subcutaneously inserted in the patient's body. [0022] The device includes a motor (e.g., stepper motor or DC motor) requiring energy for its operation. The amount of required energy may include a current of about 500 mA and voltage of about 3 Volts, i.e., 1.5 Watts of electrical power. A zinc-air battery provides a current of 10 mA and, voltage of about 1.2 Volts, i.e., 0.012 Watts of electrical power. To provide the 3 Volts required by the motor and CPU from a battery output of 1.2 Volts, a DC-DC step-up converter is used. The current requirements are provided by a pulsed power method, i.e., accumulating energy over a relatively long period of time in a high capacity capacitor and releasing it very quickly, thus, increasing the instantaneous current and generating high power pulses for a short period of time. The motor is provided with a sequence of customized pulses, also referred to as a pulse train, each pulse being characterized by its current, width, duty cycle and frequency. Each pulse's width is adjusted to fulfill the power requirements of the motor, i.e., when changing the motor rotational velocity (e.g., during acceleration or slow down), the pulses are wider than pulses associated with constant rotational velocity. It should be noted that although a stepper motor rotates in a fixed angle with each pulse provided to it, the motor output (e.g., torque or steps per second) can be adjusted by customizing the pulses. For example, short duration pulses (e.g., 0.4-0.6 milliseconds) will result in higher rotational velocity compared to long duration pulses (e.g., 0.9-1.2 milliseconds). [0023] In some embodiments, the motor is provided with pulsed power that is adjustable according to its rotational velocity. In turn, when the motor velocity changes, more power is provided to overcome the friction and inertia of the driving mechanism or pumping mechanism. On the other hand, when the velocity remains constant, only minimal power is supplied because only minor forces are exerted upon the driving mechanism or pumping mechanism. These forces may be utilized for stopping the pumping mechanism, and thereby less power would be required to stop the motor. The motor rotational velocity can be measured by counting the motor's revolutions per time unit as described in the co-owned, co-pending International Patent Application No. PCT/IL2008/000642, filed May 11, 2007, and entitled “Methods and Apparatus for Monitoring Rotation of an Infusion Pump Driving Mechanism,” the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the motor may utilize a step-up voltage converter and pulsed power mechanism. [0024] In some embodiments, the device may include a miniature energy source which is a sufficient energy source by virtue of a dedicated energy saving method employed for controlling a motor driver. Such may consider the driving mechanism's inertia and be implemented regardless of motor type, battery, pumping mechanism and other parameters and characteristics of the device. [0025] In some embodiments, the device may employ an energy saving mode for the operation of the dispensing unit. [0026] In some embodiments, a power supply mode may exploit the rotational inertia of the motor or pumping mechanism to save energy. In other embodiments, the power supply mode may exploit friction forces applied to the motor or pumping mechanism for saving energy. [0027] In some embodiments, implementing the pulsed power method by using a low power source (e.g., zinc-air battery) and energy storage device (e.g., capacitor), the motor cannot rotate for a long period of time without a controller (e.g., CPU). This safety mechanism inherently restricts an uncontrolled motor rotation which may result in drug overdose, fatal to the patient. [0028] In some embodiments, the device includes a miniature dispensing unit having a small and low power battery that is sufficient to supply energy for the entire usage duration. [0029] It is an object of some embodiments to provide accurate control of the motor's rotation while employing an energy saving mode. [0030] It is an object of some of embodiments to provide a method to control the pulse parameters of the motor to save energy during the motor operation. [0031] The foregoing and other features, aspects, and advantages of the present invention will be more apparent from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [0032] FIGS. 1 a - c show a single-part dispensing unit ( FIG. 1 b ), a two-part dispensing unit ( FIG. 1 c ) and a remote control unit. [0033] FIGS. 2 a - b show a single-part dispensing unit ( FIG. 2 a ) and a two-part dispensing unit ( FIG. 2 b ) employing a peristaltic pumping mechanism. [0034] FIGS. 3 a - b show a two-part dispensing unit employing a peristaltic pumping mechanism. [0035] FIGS. 4 a - b show a single-part dispensing unit ( FIG. 4 b ) and a two-part dispensing unit ( FIG. 4 a ) employing a syringe-piston pumping mechanism. [0036] FIG. 5 shows a sensing and monitoring device for the control of rotational movements of the driving mechanism and pumping mechanism. [0037] FIG. 6 shows a block diagram of the dispensing unit including energy suppliers and consumers. [0038] FIG. 7 shows a block diagram of an energy supply and motor control of the dispensing unit. [0039] FIGS. 8 a - b show an energy storage device for providing pulsed power. [0040] FIGS. 9 a - b show power versus time and current versus time plots of the pulsed power supplied by a capacitor. [0041] FIGS. 10 a - b are plots illustrating rotational velocity and power profiles as a function of time as supplied to the motor. [0042] FIGS. 11 a - b are plots illustrating alternative rotational velocity and power profiles as a function of time. [0043] FIG. 12 is a plot illustrating a pulse distribution required for a power profile as supplied to the motor. [0044] FIG. 13 is a plot illustrating an energy distribution during a pulse train implementing the power profile shown in FIG. 10 b. [0045] FIG. 14 is a plot illustrating an energy distribution during a pulse train implementing the power profile shown in FIG. 11 b. [0046] FIG. 15 is a plot illustrating an example of a pulse train implementing the rotational velocity shown in FIG. 10 a. [0047] FIG. 16 is a plot illustrating an example of a pulse train implementing the rotational velocity shown in FIG. 10 a. [0048] FIG. 17 is a plot illustrating an example of a pulse train implementing the rotational velocity shown in FIG. 11 a. DETAILED DESCRIPTION [0049] A dispensing unit ( 10 ) and a remote control unit ( 40 ) are described herein. In some embodiments, the dispensing unit ( 10 ) may include a single part (as shown in FIG. 1 b ) or two parts (as shown in FIG. 1 c ). The two-part dispensing unit includes a reusable part ( 100 ) and a disposable part ( 200 ). The dispensing unit ( 10 ) may employ different dispensing mechanisms, including without limitation a syringe-type reservoir with a propelling plunger, peristaltic positive displacement pump In some embodiments, the dispensing unit ( 10 ) can be adhered to the patient's body by a skin adherable cradle unit. An example of such a cradle unit is disclosed in the co-owned, co-pending U.S. patent application Ser. No. 12/004,837 and International Patent Application No. PCT/IL2007/001578, the disclosures of which are incorporated herein by reference in their entireties. The term “dispensing unit” is not limited to fluid delivery. In some embodiments, the dispensing unit ( 10 ) may be capable of dispensing fluid (e.g., insulin) to a patient's body or sensing analyte (e.g., glucose) in the body. [0050] Infusion programming, data transferring and control of the dispensing unit ( 10 ) can be carried out by a remote control unit ( 40 ), which may be configured as a personal digital assistant (“PDA”), a hand watch, a cellular phone, or any other means. The remote control unit ( 40 ) is capable of establishing a unidirectional communication with the dispensing unit ( 10 ), i.e., the remote control unit ( 40 ) only transmits data to the dispensing unit ( 10 ) or only receives data from the dispensing unit ( 10 ). The communication link between remote control unit ( 40 ) and dispensing unit ( 10 ) can be also bidirectional, i.e., the remote control unit ( 40 ) is capable of transmitting and receiving data to and from the dispensing unit ( 10 ). [0051] FIGS. 2 a - b show exemplary embodiments of the dispensing unit ( 10 ) employing a peristaltic pumping mechanism for dispensing fluid to a user's body. FIG. 2 a shows a single-part dispensing unit ( 10 ). The fluid is delivered from a reservoir ( 220 ) provided in the dispensing unit ( 10 ) through a delivery tube ( 230 ) to an exit port ( 213 ). The peristaltic pump includes a rotary wheel ( 110 ) provided with rollers (not shown) and a stator ( 190 ). Rotation of the rotary wheel ( 110 ) and periodic squeezing of the delivery tube ( 230 ) against the stator ( 190 ) positively displaces fluid from the reservoir ( 220 ) to the exit port ( 213 ). An example of such a positive displacement pump is disclosed in the co-owned, co-pending U.S. patent application Ser. No. 11/397,115, filed on Apr. 3, 2006, the disclosure of which is incorporated herein by reference in its entirety. A driving mechanism ( 120 ) for rotating the rotary wheel ( 110 ) can be provided. The driving mechanism ( 120 ) includes a gear and a motor. The motor can be a Stepper motor, a DC motor, SMA actuator or any other motor. The driving mechanism ( 120 ) is controlled by electronic components ( 130 ) residing in the dispensing unit ( 10 ). The electronic components ( 130 ) may include a controller (not shown), a processor ( 132 ), a transceiver ( 131 ) and/or a transmitter ( 133 ). An appropriate power source ( 240 ) and an energy storage device ( 252 ) (e.g., a capacitor) are also provided. The power source ( 240 ) may include without limitation one or more batteries, such as a button-sized zinc-air battery. [0052] In some embodiments, the power source ( 240 ) may be a button battery and the energy storage device ( 252 ) may be a high capacity (e.g., about 0.2 F) capacitor. Using a button battery usually requires the supply of pulsed power in order to increase the current output by the battery. The pulsed power mode is established by periodically charging and discharging the high capacity capacitor. Infusion programming of the dispensing unit ( 10 ) can be carried out either by remote control unit ( 40 ) and/or by manual buttons ( 15 ) provided on the dispensing unit ( 10 ). [0053] FIG. 2 b shows a two-part dispensing unit ( 10 ) that includes a reusable part ( 100 ) and a disposable part ( 200 ). The reusable part ( 100 ) includes a positive displacement pump provided with rotary wheel ( 110 ), driving mechanism ( 120 ), and electronic components ( 130 ). The disposable part ( 200 ) includes reservoir ( 220 ), delivery tube ( 230 ), power source (e.g., button battery) ( 240 ), energy storage device ( 252 ), exit port ( 213 ), and stator ( 190 ). Pumping is enabled upon attachment of the two parts to each other. This arrangement is discussed in the co-owned, co-pending U.S. patent application Ser. No. 11/397,115, filed on Apr. 3, 2006, the disclosure of which is incorporated herein by reference in its entirety. The power source ( 240 ) may also be located in the reusable part ( 100 ) and can be rechargeable. [0054] FIGS. 3 a and 3 b show respectively an embodiment of the two-part dispensing unit ( 10 ) prior to (as shown in FIG. 3 a ) and subsequent to (as shown in FIG. 3 b ) connection of the two parts. The reusable part ( 100 ) contains a peristaltic pumping mechanism provided with rotary wheel ( 110 ) and a driving mechanism ( 120 ) having a motor ( 121 ), a worm ( 126 ), a shaft ( 128 ) and gears ( 124 ). The reusable part ( 100 ) also contains electronic components ( 130 ). The disposable part ( 200 ) includes reservoir ( 220 ), delivery tube ( 230 ), power source ( 240 ), exit port ( 213 ), and stator ( 190 ). The power source ( 240 ) may be a zinc-air battery or button battery. [0055] FIGS. 4 a - b show embodiments of the dispensing unit ( 10 ) employing a piston-plunger pumping mechanism for dispensing fluid to a user's body. FIG. 4 a shows a two-part dispensing unit ( 10 ) having a reusable part ( 100 ) and a disposable part ( 200 ). The disposable part ( 200 ) includes reservoir ( 220 ) provided with plunger assembly ( 110 ), power source (e.g., battery) ( 240 ), energy storage device ( 252 ), and exit port ( 213 ). In alternative embodiments, the plunger assembly ( 110 ) may be located in the reusable part ( 100 ) or be shared by both parts. The reusable part ( 100 ) includes a driving mechanism ( 120 ), which has a motor ( 121 ) (e.g., Stepper motor, DC motor, or SMA actuator) and a driving gear (not shown) for displacing the plunger assembly ( 110 ). The driving mechanism ( 120 ) is controlled by electronic components ( 130 ), which has a controller (not shown), a processor ( 132 ), a transceiver ( 131 ), and/or a transmitter ( 133 ). Infusion programming can be carried out by a remote control unit (not shown) and/or by one or more buttons ( 15 ) provided on the dispensing unit ( 10 ). The power source ( 240 ) may be located in the reusable part ( 100 ) and may be rechargeable. An example of such a dispensing unit is disclosed in the co-owned, co-pending U.S. Provisional Patent Application No. 61/123,509, filed on Apr. 9, 2008, the disclosure of which is incorporated herein by reference in its entirety. [0056] FIG. 4 b shows a single-part dispensing unit ( 10 ), which includes substantially similar components as the two-part dispensing unit ( 10 ). The components of the single-part dispensing unit ( 10 ) are deployed within a common housing ( 11 ). The embodiments shown in FIGS. 4 a - b are disclosed in the co-owned, co-pending International Patent Application No. PCT/IL2008/000641, the disclosure of which is incorporated herein by reference in its entirety. [0057] Any of the above-mentioned embodiments may be provided with a sensing and monitoring device for controlling operation of the driving mechanism ( 120 ). FIG. 5 shows this device employing a photo interrupter ( 113 ) as disclosed in the co-owned, co-pending International Patent Application No. PCT/IL2008/000642, the disclosure of which is incorporated herein by reference in its entirety. The sensing and monitoring device is provided with an encoder vane ( 116 ) configured as a 180 degree sector, which is affixed to a shaft ( 128 ) such that the encoder vane ( 116 ) rotates with the shaft ( 128 ) at the same rotational velocity. Photo-interrupter ( 113 ) is positioned such that as encoder vane ( 116 ) rotates it passes through space (S) between LED ( 112 ) and light detector ( 114 ). The motor's ( 121 ) rotational velocity can be derived from the shaft's ( 128 ) rotational velocity by taking into consideration the gear ( 124 ) reduction ratio. For example, when the shaft ( 128 ) rotates at 1 rotation per minute (RPM) and the gear ( 124 ) ratio is 3:1; the motor's ( 121 ) speed is 3 RPM. Other sensing and monitoring devices may also be employed to measure the motor's ( 121 ) rotational velocity. [0058] FIG. 6 shows schematically the power source ( 240 ) and energy consuming components of the dispensing unit ( 10 ) controlled by controller ( 132 ). The energy consuming components include: a communication device ( 134 ), which may include without limitation RF, IR and other communication types (e.g., magnetic relay, manual buttons, audible commands). a pumping mechanism ( 136 ) actuated by a driving mechanism having a motor and motor driver. a sensing and monitoring device ( 138 ), which may include without limitation an occlusion sensor or motion sensor. an indication device ( 140 ), (also referred to as “notification device”), which may include without limitation a buzzer or vibration alarm. [0063] FIG. 7 shows a flow chart depicting an energy supply and control of the motor ( 121 ). In practice, a low price, small-sized power source ( 240 ) (e.g., button battery) may be used, particularly a small quantity thereof, to provide a dispensing unit ( 10 ) that is of miniature size and lightweight. Due to the small size of a button battery, the electrical power output produced thereby, i.e., current (“i”) and voltage (“v”), is substantially lower than the electrical power required for motor operation, i.e., a condition is satisfied whereby [0000] i battery ·v battery <<i motor ·v motor or W battery <<W motor [0064] For example, a zinc-air battery has a maximum power output of about 0.03 Watts (e.g., current of about 25 mA and voltage of about 1.2 Volts), while the motor ( 121 ) requires electrical power of 1.5 Watts (e.g., current of about 500 mA and voltage of about 3 Volts). It can be seen in this example that the electrical power (W motor ) required the motor is times larger than what battery (W battery ) is able to supply. The electric power required by the motor is not limited to the particular electrical power indicated above. [0065] Thus, in order to enable operation of the motor ( 121 ), the voltage and current supplied thereto are increased. Voltage increase can be carried out by virtue of a DC-DC converter ( 254 ) which can for example convert the 1.2 Volts supplied by the battery, i.e., power source ( 240 ), to the voltage required by the motor ( 121 ), i.e., 3 Volts. Increasing the current can be carried out by a pulsed power method, i.e., by charging the energy storage device ( 252 ) (e.g., a 0.2 F capacitor) for approximately 1 second and then discharging it for about 20 milliseconds. This enables multiplication of the current by 50 times. [0066] The 3V voltage is also supplied to the controller ( 132 ) and to the sensing and monitoring device ( 138 ) (e.g., revolution counters). Such a sensing and monitoring device ( 138 ) is disclosed in the co-owned, co-pending International Patent Application No. PCT/IL2008/000642, as noted above. The motor driver ( 255 ), which is controlled by the controller ( 132 ), operates the motor ( 121 ) by providing it with a pulsed power, as shown by line ( 109 ). The pulsed power is supplied by the energy storage device ( 252 ). [0067] In some embodiments, the motor's ( 121 ) operation is controlled by the principle of a closed-loop feedback, according to which the amount of power supplied to the motor ( 121 ) is adjusted based on the motor's ( 121 ) rotational velocity ( 38 ). Sensing and monitoring device ( 138 ) (e.g., revolution counter or rotation sensor) measures the motor's ( 121 ) output as shown by dashed line ( 22 ) and provides the controller ( 132 ) with the required data, including without limitation, the motor's ( 121 ) instant rotational velocity, as shown by dashed line ( 38 ). In some embodiments, the sensing and monitoring device ( 138 ) merely provides a number of revolutions of the motor ( 121 ), while the velocity is calculated by the controller ( 132 ). In some embodiments, the motor's ( 121 ) mechanical energy may be converted into electrical energy, as shown by line ( 108 ). This energy can be stored in the energy storage device ( 252 ) for later use. [0068] FIGS. 8 a - b show the main components depicted in FIG. 7 : the motor ( 121 ), the energy storage device ( 252 ), and the power source ( 240 ) connected by flat strip connectors ( 241 ) to other electrical components ( 130 ). The energy storage device ( 252 ) can be a high capacity capacitor having a capacity of 180 mF to 200 mF. It is advantageous if the capacitor has a flat configuration and reduced dimensions (e.g., 29 mm×17 mm×0.9 mm). Consequently, the capacitor may be placed parallel to the electronic components ( 130 ) (e.g., a printed circuit board), which allows the dispensing unit ( 10 ) to be kept as small and thin as possible. In practice, the capacitor having the above-mentioned configuration and dimensions provides a dispensing unit having thickness less than 15 mm. [0069] FIGS. 9 a - b are power-time plots illustrating a pulsed power produced by a capacitor and supplied to the motor. In some embodiments, the supply of pulsed power includes two modes: accumulation mode ( 400 ) and release mode ( 500 ). During the accumulation mode ( 400 ), a battery charges the capacitor. During the release mode ( 500 ), the capacitor is being discharged and supplies current to power consuming components of the dispensing unit, including without limitation, the motor and electronic elements. [0070] The ratio between the accumulation time t (“t accumulaton ”) and release time (“t release ”) “t release ”) is proportional to the ratio between the power required for operation of power consuming components, such as a motor (“W motor ”) and the electrical Power outputted by a battery (“W battery ”), i.e., [0000] taccumulation trelease  α  Wmotor Wbattery [0071] FIG. 9 a shows a graph of a typical charging/discharging cycle of the capacitor having the two modes. It is clear that the duration of the accumulation mode ( 400 ) is substantially longer than the release mode ( 500 ). In practice, this duration may be 50 times longer. Therefore, the maximal pulse train duration applied for activating the motor is less than the release mode ( 500 ) duration. In alternative embodiments, the charge stored in the capacitor may be monitored (e.g., by an A/D converter), thereby allowing a dynamic control over the discharging and recharging of the capacitor to be achieved. [0072] FIG. 9 b shows schematic graphs of the power (“Power”) and current (“i”) of a charging/discharging cycle of the capacitor. During accumulation mode ( 400 ), the energy that is supplied by the battery is accumulated and stored in the capacitor. In practice, when applying a 0.2 F capacitor and a zinc-air battery, it may take 980 milliseconds. The energy (p 1 ) that is stored in the capacitor gradually increases while the supplied current (i 1 ) remains constant. During the release mode ( 500 ), the capacitor discharges and, supplies the required amount of power to the power consuming components. When the capacitor has 0.1 F capacity and the battery is a silver-oxide button-sized battery with 0.186 Watt output, the release mode can take 10 milliseconds, while the accumulation time is about 8 times higher. Discharged power and current are designated as p2 and i2, respectively. In some embodiments, there may be continued charging of the capacitor, even during the discharge phase, which shortens the time interval between two consecutive pulses. If the capacitor is fully loaded, the charging process may not continue. [0073] FIG. 10 a shows the angular velocity (ω m ) of the motor versus time (t) and FIG. 10 b shows the corresponding power (P) discharged from the capacitor and supplied to the motor. During this period, the motor operates the pump to deliver fluid (e.g., insulin) via the dispensing unit. When the motor is rotated based on energy from the capacitor only a limited amount of fluid can be delivered during a single charging/discharging cycle and, therefore, more than one cycle may be required to deliver the appropriate amount of fluid required for therapeutic treatment. [0074] In some embodiments, a variant pulse train can be supplied to the motor each time the capacitor is being discharged. The amount of power supplied during the discharge of the capacitor depends upon whether the motor rotates with constant or variable rotational velocity. [0075] At t=t 0 , the motor begins to rotate and its rotational velocity should be gradually increased up to a certain velocity. The increasing velocity is designated as a 1 . The velocity increases due to supplying a certain amount of electrical power delivered by the capacitor to the motor (P>0). This power is designated as b 1 . At t=t 1 , the motor's angular velocity is constant, as represented on the graph in FIG. 10 a as a plateau. The achieved velocity is designated as a 2 . The amount of power required to keep the motor rotating at constant velocity a 2 can be b 2 , which is less than b1 since constant angular velocity (ω m ) is maintained due to inertia. Thus, the required power (b 2 ) is less than b 1 . During the time interval from t=t 2 to t=t 3 , the velocity of the motor is decreased until full stop (the decreasing velocity is designated as a 3 ). The velocity can be reduced by supplying power b3, as may be required to overcome inertia until stopping the motor. In some embodiments, the time interval from t=t 1 to t=t 3 is about 20 milliseconds. [0076] The pattern of the pulses is typically predetermined when the pulse trains are tailored. That is, the dispensing pump is initially configured with at least one pulse train. In some embodiments, the dispensing pump controller can adjust and combine various pulses and pulse trains as needed. In other embodiments, the controller can adjust and schedule the pulse train (e.g., energy, number of pulses, width of pulses, or frequency) based on the energy stored in the energy storage device or power source. [0077] FIGS. 11 a - b refer to another embodiment and show graphs of the angular velocity (ω m ) of the motor versus time (t) and the corresponding power (P) required by the motor versus time (t). The graphs depict variations in velocity and power during drug delivery, while an alternative operational mode of the motor is employed for saving energy. The two first phases designated by a 1 , a 2 and b 1 , b 2 are identical to those referred to in FIGS. 10 a - b. During the time interval starting at t=t 2 and ending at t=t 3 , the velocity of the motor is decreased merely due to friction forces until a full stop (the reducing velocity is designated in FIG. 11 a as a 4 ). FIG. 11 b shows that in this time interval (t=t 2 to t=t 3 ), the motor continues to rotate and no energy is required. Therefore, energy associated with the rotation of the motor is available for use by the energy consuming components while the motor itself does not require supply of energy, i.e., during this phase the motor may operate like a dynamo. [0078] FIG. 12 shows current (i) supplied to the motor versus time (t), during a pulse train employing the operation mode described in FIGS. 10 a - b. The current (i) is supplied by pulses while each pulse is characterized by a time interval (“t”) (i.e., a period). The initial pulse (e.g., between t 1 and t 2 ) has long period t 1 , typically lasting for 1 to 1.5 millisecond, for setting the driving mechanism into motion and for accelerating the motor. The duration of each consecutive pulse is either equal or shorter than the former. In some embodiments, the second phase has a minimal pulse period t 2 of about 0.5 milliseconds. This trend is turned over when the motor speed is decreased, i.e., in this phase the motor is decelerating and each period t 3 of each pulse is either equal or longer than the former. [0079] For example, the duration of the n pulses of an exemplary pulse train can be written as shown in the following equation: [0000] t 1 ≧t 2 ≧t 3 ≧ . . . ≦t n−1 ≦t n [0080] Since a pulse duration (t) is inversely proportional to the angular velocity of the motor (ω), (t α 1/ω), the above equation can be accordingly rewritten as follows: [0000] ω 1 ≧ω 2 ≧ω 3 ≧ . . . ≦ω n−1 ≦ω n [0081] According to some embodiments, every pulse is tailored to rotate the motor's axis through an identical angle (known as a ‘step’). Enabling a constant angular rotation resulting from each discrete pulse and providing the same amount of fluid is highly advantageous in that it simplifies the dispensing pump control and calibration, for example, when calculating the number of pulses needed to deliver a required amount of therapeutic fluid. This is achieved by maintaining constant the multiple of pulse duration by the rotational velocity it causes: [0000] t 1 ·ω 1 =t 2 ·ω 2 =t 3 ·ω 3 = . . . t n−1 ·ω n−1 =t n ·ω n =18° [0082] FIGS. 13-14 shows current (i) supplied to the motor versus time (t), according to some embodiments. Conventional methods for supplying energy to motors of infusion devices employ pulses in which a constant level of power is provided to the motor during each pulse period (i.e., a 100% duty cycle). This method can be employed to the device disclosed herein as well, i.e., power pulse trains may be supplied to the motor while each pulse train includes pulses of power during which power would be supplied non-invariantly at three various levels b 1 , b 2 and b 3 lasting during respective periods t 1 , t 2 and t 3 following without interruption. [0083] In some embodiments, supply of power may be organized during each pulse with interruptions. As shown schematically in FIG. 13 there could be provided three different operational phases and each pulse of the pulse train includes: A discharge phase ( 510 )—pulsed power is provided to the motor by discharging a capacitor. A null phase ( 520 )—power supply is interrupted and power is not supplied to and neither generated by the motor. A charge phase ( 530 )—energy is generated by the motor and this energy can be supplied to power consuming components. The pulses typically include discharge ( 510 ) and null ( 520 ) phases or null ( 520 ) and charge ( 530 ) phases but may include only discharge ( 510 ) or charge ( 530 ) phases. [0088] FIG. 13 shows a graph of the current (i) supplied to the motor versus time (t), for generating the angular velocity according to principles described in connection with FIGS. 10 a - b. The graph shows a single pulse train, which includes three initial pulses. Each one of initial pulses (e.g., the pulses designated as p 1 , p 2 and p 3 ) have two phases: a discharge phase ( 510 ) (designated as w 1 , w 2 and w 3 ), followed by a null phase ( 520 ). [0089] In some embodiments, the null phase ( 520 ) is 10% to 30% of the pulse period, i.e., the width of these pulses is of 70% to 90%. In some embodiments, the dispensing pump controller applies pulse width modulation (PWM) for changing the width of the pulses to generate the determined pulse train. It should be appreciated that other methods for exploiting the motor's inertia for reducing the energy supply may be implemented, such as by changing the pulse period, amplitude, or shape (e.g., triangle, square, sine wave). [0090] Halting motor operation is carried out by the last pulses of the pulse train (e.g., p n−1 and p n ). The discharge phase ( 510 ) of these pulses equals the duty cycle; p n−1 =ω n−1 and p n =ω n . This causes the motor to stop almost immediately, so that no excess fluid is delivered by the dispensing unit. [0091] FIG. 14 shows a graph of current (i) supplied to the motor versus time (t), for implementing the principle described above in connection with FIGS. 10 a - b. The graph shows a pulse train. The last pulses of the pulse train (e.g., p n−1 and p n ) include a single phase, i.e., the charge phase ( 530 ). This mode of operation enables the motor to generate energy due to its rotation and to transfer it to an energy storage device. [0092] The halting method is shown in FIGS. 11 a - b and may require the use of a sensing and monitoring device (e.g., a sensor) to detect the relative position (i.e., angle) of the rotary wheel. The sensing and monitoring device may be required to achieve an accurate fluid delivery employing a flow correction mechanism. [0093] Although particular embodiments have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the claims. In particular, it is contemplated by the inventors that various substitutions, alterations, and modifications may be made without departing from the spirit and scope of the devices and methods defined by the claims. Other aspects, advantages, and modifications are considered to be within the scope of the claims. The claims presented are representative of the devices and methods disclosed herein. Other, presently unclaimed devices and methods, are also contemplated. The inventors reserve the right to pursue such devices and methods in later claims. [0094] The following examples serve to illustrate embodiments of the disclosed devices and methods and are given for illustrative purposes only and are not intended to limit the present disclosure. EXAMPLES [0095] FIGS. 15, 16 and 17 show examples of pulse train supplied to the motor according to some embodiments. These figures show the discharge phase ( 510 ), in which power is supplied to the motor, the null phase ( 520 ) in which no power is supplied to the motor and the charge phase ( 530 ) when power is generated by the motor. [0096] The pulse trains were tailored to reduce the power provided to the motor while each pulse rotates the motor by 20 degrees. The power source in these examples is a zinc-air button battery, a 0.2 F capacitor and two phase motor commercially provided by Nidec Copal Corporation (U.S.A.). [0097] The pulses are provided by PWM and/or by changing the pulse period. Example 1 [0098] FIG. 15 shows a pulse train for rotating the motor by 160 degrees composed of three sets of pulses: The first set of pulses is applied for accelerating the motor and includes three pulses lasting for 2.3 milliseconds. The second set of pulses is designed for maintaining the motor speed and includes four pulses, each having a 1.15 millisecond period. This set of pulses rotates the motor by the same angle as the first set but requires 50% less power. To increase the energy efficiency, the last two pulses may have 80% width of the duty cycle. The third set of pulses is for stopping the motor and is identical to the first set but in reversed phase. [0102] In this example all the pulses have 100% pulse width (i.e., the pulse width equals the pulse duration). Example 2 [0103] FIG. 16 shows a pulse train designed to rotate the motor by 520 degrees at a lower rotation velocity than that disclosed in Example 1. This pulse train is composed of three sets of pulses: The first set of pulses is applied for accelerating the motor and includes four pulses lasting for 1.0 millisecond. The second set of pulses is designed for maintaining the motor speed and includes 22 pulses, each having a 0.7 millisecond period. If the pulses in this set were tailored as the first set (as described in the prior art), the energy consumption of this set would be 40% higher. The third set of pulses includes two stop pulses lasting for 1.0 millisecond, wherein a 90% duty cycle is applied to stop the motor rotation. Example 3 [0107] FIG. 17 shows a pulse train that does not apply power to stop the motor. The pulse train includes two sets of pulses: The first set of pulses is applied for accelerating the motor and includes four pulses lasting for 1.0 millisecond. The second set of pulses is designed for maintaining the motor speed and includes 22 pulses, each having a 0.7 millisecond period. Also shown are two pulses ( 530 ) supplied by the motor for recharging the capacitor, i.e., the motor functions as a dynamo by transferring kinetic energy to electrical power. [0111] Example 3 requires less energy than the pulse train described in Example 2 and provides two more steps to the motor (which are applied to stop the motor in Example 2). The inertia of the motor at the end of this pulse train can be converted by the motor to electrical power, which can be provided to other electrical components of the dispensing unit. This pulse train requires 29.1 J, provides 26 steps of rotation and can also retrieve part of the excess power provided to the motor. A standard method of motor activation would be composed of 20 pulses lasting 1.0 millisecond each, whereby at least two of them are applied for stopping the motor. Thus, less than 20 steps can be provided in this method.

1a

FIELD OF THE INVENTION The present invention relates to chemical compositions which inhibit the proteolytic activity of peptidases, and more particularly to peptidomimetic inhibitory compounds specific for HIV protease. BACKGROUND Enzyme activity is known to be a vital factor in the lifecycle of viruses which infect mammals. Effective inhibitors of viral enzymes would, therefore, be useful therapeutic tools in the treatment of viral infections such as by HIV (Human Immunodeficiency Virus), and viral infection related diseases such as AIDS (Acquired Immune Deficiency Syndrome)aand ARC (AIDS Related Complex). HIV, the causative agent of the AIDS, is a member of the lentivirus family of retroviruses (Gonda et al., 1985, "Sequence Homology and Morphological Similarity of HTLV III and Visna Virus, A Pathogenic Lentivirus", Science, 227:173; Sonigo et al., 1985, "Nucleotide Sequence of the Visna Lentivirus: Relationship to the AIDS Virus", Cell, 42:369). HIV, in common with other retroviruses, encodes a number of enzymes that are necessary for its life cycle (Weiss et al., 1982, The Molecular Biology of RNA Tumor Viruses, 2nd ed., Cold Spring Harbor Laboratory, New York; Ratner et al., 1985, "Complete Nucleotide Sequence of the AIDS Virus, HTLV III", Nature, 313:277). In the absence of such enzymes, viable viral infections do not occur (Weiss et al., supra). The only currently used therapeutic for AIDS, AZT, is an inhibitor of the viral reverse transcriptase (Mitsuya et al., 1986, "Inhibition of the In Vitro Infectivity and Cytopathic Effects of HTLV III", Proc. Natl. Acad. Sci. U.S.A. 83:1911). Other known viral enzymes include an RNAse, an integrase and a protease, all of which are essential for the viral life cycle (Mitsuya et al., 1987, "Strategies for Antiviral Therapy in AIDS", Nature, 325:773). The protease found in HIV (hereinafter "HIV protease") is responsible for cleavage of the gag and gag-pol polyproteins into mature peptides (Ratner et al. supra; Kramer et al., 1986, "HTLV III Gag Protein is Processed in Yeast cells by the Virus Pol Protease", Science, 231:1580; Farmerie et al., 1987, "Expression and Processing of the AIDS Virus Reverse Transcriptase in Escherichia coli", Science, 236:305). The amino acid sequence for the gag polyprotein is described in Ratner et al, 1985, Nature, 313:277. From the known location at the 5' end of the pol gene and the inferred protease cleavage sites (Pearl et al., 1987, "Sequence Specificity of Retroviral Proteases," Nature, 328:482), the predicted size of the protease is 99 amino acids. HIV protease, as with other retroviral proteases, has a homology with cellular aspartyl proteases (Katch et al., 1987, "Inhibition of Retroviral Protease Activity by an Aspartyl Proteinase Inhibitor", Nature, 329:654 ). Kohl et al., 1988, "Active Human Immuno-deficiency Virus Protease is Required for Viral Infectivity.", Proc. Natl. Acad. Sci. U.S.A., 85:4686, demonstrated that active HIV protease participation is required for HIV replication. The article by J. R. Huff, 1991, "HIV Protease: A Novel Chemotherapeutic Target for AIDS.", J. Med. Chem., 34:2305, is a state of the art review of currently documented HIV protease inhibitors. The inventive compounds differ from those taught in the prior art of which the applicants are aware in that they represent peptidomimetics which contain a novel class of isosteres which are not presently known. OBJECTS OF THE PRESENT INVENTION The object of the present invention is to provide for peptidomimetic compounds which have been shown to inhibit the proteolytic activity of HIV protease. Another object of the present invention is to provide for therapeutic compositions comprising the peptidomimetic compounds, which contain a novel class of isosteres. A further object of the present invention is to provide a method for treating AIDS by administering to patients infected with the viruses that are causative agents of AIDS, a therapeutically effective amount of the novel compounds of the present invention. These and other objects, aims and advantages are provided by the present invention and disclosed in the following specification. SUMMARY OF THE INVENTION The basic principlesbbehind the present invention are that: 1) HIV protease ordinarily modifies certain HIV protein substrates after these proteins have been translated, without such downstream processing, the proteins cannot be used in HIV replication; 2) to modify the substrate-proteins, HIV protease, must first hold the substrate in position through complex conformational and electron interactions between the molecular structures of the substrate and the protease; and 3) "peptidomimetics" are compounds which mimic substrate peptides and compete for molecular sites of interaction on the enzyme specific for the peptides. In the present case, the claimed compounds inhibit post translational modification by blocking such sites on HIV protease, preventing further processing of HIV proteins. Specifically, the present invention relates to an active compound essentially containing at least one of the following isosteres: ##STR1## where: R 1 can be a straight, branched, cyclic, bicyclic, aromatic or hetereocyclic, 1-12 carbon side chain, which can optionally be substituted with one or more heteroatoms such as N, O, S, Cl or F, or any combinations thereof; R 2 can be --CH 2 OH, --CH 2 NH 2 , or a straight, branched, 1-4 carbon ester, carboxylic acid, or amide; R 3 can be hydrogen, a straight, branched, cyclic, bicyclic, aromatic or hetereocyclic, 1-12 carbon side chain, which can optionally be substituted with one or more heteroatoms such as N, O, S, Cl or F, or any combinations thereof; R 4 can be hydrogen, a straight, branched, cyclic, bicyclic, aromatic or hetereocyclic, 1-12 carbon side chain, which can optionally be substituted with one or more heteroatoms such as N, O, S, Cl or F, or any combinations thereof; and R 3 and R 4 can also be part of a heterocyclic structure comprised of 3-6 carbons, optionally further substituted with heteroatoms such as N, O, S, Cl or F. More specifically, the isostere, spacer-intermediates of the present invention has essentially the following structures: ##STR2## where R 1 , R 2 , R 3 and R 4 have the same meaning as in Formula (I) For purposes of this disclosure, an "isostere" is a singular term referring to a collection of functional groups within a chemical's molecular structure which have electron and conformational properties which are similar to another isostere (usually in another molecule). Isosteres can, but do not necessarily have to be, physically similar in structure. Isosteres are integral components of the present compounds and recur in all the claimed structures (see Formulas I and II, above, and Formulas III and IV, below). The preferred embodiments have isosteres mainly comprised of a proline and a branched, six carbon hexyl group. In the preferred embodiments, the fifth carbon on the hexyl group can have either a hydroxl (making the fifth carbon a methanol group) or a methyl via an ester linkage (making the fifth carbon a carboxy-methyl ester). To the left of the isostere group (see Formula III, below) is the N terminal end which can be further varied. The preferred embodiments have either a carbamate or an amide linkage at the N terminus of the isosteres which link either a benzene ring or a heterocyclic quinoline. To the right of the isostere group is the C terminal end which can also be varied. The preferred embodiments all have an isoleucine-benzyl-amide substitution at the C terminus of the isosteres. The peptidomimetic compounds of the present invention can be expressed as follows: ##STR3## where R 1 R 2 , R 3 and R 4 have the same meaning as in Formula (I), and where: R 5 can be a straight, branched, cyclic, bicyclic, aromatic or hetereocyclic, 1-12 carbon, amide, carbamate, or urea side chain, which can optionally be substituted with one or more heteroatoms such as N, O, S, Cl or F, or any combinations thereof; R 6 can be a straight, branched, cyclic, bicyclic, aromatic or hetereocyclic, 1-12 carbon side chain, which can optionally be substituted with one or more heteroatoms such as N, O, S, Cl or F, or any combinations thereof; X can be an amide, carbamate or urea linkage, an asparagine or any other known amino acid or combinations thereof; and Z can be an amide linkage, an isoleucine, or any other known amino acid or combinations thereof. The isostere, spacer-intermediates of the present invention can alternatively be expressed as follows: ##STR4## where: R 7 can be a straight, branched, cyclic, bicyclic, alkyl with 1-12 carbon atoms, an aralkyl, aryl, or a hetereocyclic with 5-10 carbon atoms, which can optionally be substituted with at least one radical selected from the group consisting of a halogen, --NR'R", --OR', and --SR'; R' and R" can independently be a hydrogen, straight or branched alkyl with 1-6 carbon atoms, or an aralkyl with 7-10 carbon atoms, or an aryl with 6-10 carbon atoms; R 8 can be --CH 2 OH, --CH 2 NH 2 , or a straight, branched, 1-4 carbon ester, carboxylic acid, or amide; R 9 and R 10 can independently be a hydrogen, a straight, branched, cyclic, bicyclic, aromatic or hetereocyclic, 1-12 carbon side chain, which can optionally be substituted with at least one radical selected from the group consisting of a halogen, --NR'R", --OR', and --SR'; R 9 and R 10 can also be part of an alkyl or heteroalkyl chain which can optionally be substituted with at least one radical selected from the group consisting of a halogen, --NR'R", --OR', and --SR'; Q can be a hydrogen or a group of the formula: ##STR5## wherein R 11 is --NR'R" or --OR', n is an integer from 0 to 4, and R 12 is an amino acid which can be different or the same in the chain with n units; and J can be a hydroxyl or a group of the formula: ##STR6## The present invention further comprises therapeutic compositions comprising the above compounds, methods for treating patients inflicted with AIDS viruses by administering a therapeutically effective amount of the present compositions, and a novel method for preparing the isosteres which form the backbone of the present compounds. Thus, the present disclosure describes in further detail: 1) a novel class of peptidomimetic compounds, containing novel isosteres; 2) a novel process of making the isosteres that are common to the class of peptidomimetics; and 3) novel methods of using the peptidomimetic compounds. DESCRIPTION OF THE INVENTION The compounds of the present invention are initially synthesized by aldol-type addition of ester enolates to activated imines. The compounds are further modified by standard organic synthesis techniques. The specific synthesis details are given in the examples which follow. In vitro testing per methods as described in Tamburini et al., 1990, "A Fluorometric Assay for HIV-Protease Activity Using High-Performance Liquid Chromatography", Analytical Biochemistry, 186:363, demonstrates that the compounds of the present invention inhibit HIV protease with mean IC: of about 50 nM. The active compounds of the present invention may be used as follows: (a) the treatment or prophylaxis of diseases caused by HIV I, HIV II, and HIV III infections such as AIDS, and stage variations of AIDS such as AIDS related complex, and the suppressed immune response and encephalopathy caused by HIV; (b) for the treatment and prophylaxis of an HTLV I or HTLV II infection; (c) for the treatment and prophylaxis of the AIDS carrier or transmitter states; and (d) for the treatment or prophylaxis of infections and diseases caused by retroviruses. The present invention encompasses pharmaceutical formulations which, in addition to non-toxic, inert pharmaceutically suitable excipients, contain the compounds of the invention. The present invention also includes pharmaceutical formulations in dosage units. This means that the formulations are present in the form of individual part, for example, tablets, dragees, capsules, caplets, pills, suppositories and ampules, the active compound content of which corresponds to a fraction or a multiple of an individual dose. The dosage units can contain, for example, 1, 2, 3 or 4 individual doses for 1/2, 1/3 or 1/4 of an individual dose. An individual dose preferably contains the amount of active compound which is given in one administration and which usually corresponds to a whole, one half, one third or one quarter of a daily dose. By non-toxic inert pharmaceutically suitable excipients there are to be understood solid, semi-solid or liquid diluents, fillers and formulation auxiliaries of all types. Preferred pharmaceutical formulations which may be mentioned are tablets, dragees, capsules, caplets, pills, granules, suppositories, solutions, suspensions and emulsions, paste, ointments, glues creams, lotions, dusting powders and sprays. Tablets, dragees, capsules, caplets, pills and granules can contain the active compounds in addition to the customary excipients, such as (a) fillers and extenders, for example, starches, lactose, sucrose, glucose, mannitol and silicic acid, (b) binders, for example, carboxymethylcellulose, alginates, gelatin and polyvinylpyrrolidone, (c) humectants, for example, glycerol, (d) disintegrating agents, for example, agar-agar, calcium carbonate and sodium carbonate, (e) solution retarders, for example, paraffin and (f) absorption accelerators, for example, quaternary ammonium compounds, (g) wetting agents, for example, cetyl alcohol and glycerol monostearate, (h) absorbents, for example, kaolin and bentonite and (i) lubricants, for example, talc, calcium stearate, magnesium stearate and solid polyethylene glycols, or mixtures of the substances listed under (a) to (i) directly hereinabove. The tablets, dragees, capsules, caplets, pills and granules can be provided with the customary coatings and shells, optionally containing opacifying agents and can also be of such composition that they release the active compounds only or preferentially in a certain part of the intestinal tract, optionally in a delayed manner. Examples of embedding compositions which can be used are polymeric substances and waxes. The active compounds can also be present in microencapsulated form, if appropriate with one or more of the abovementioned excipients. Suppositories can contain, in addition to the active compounds, the customary water-soluble or water-insoluble excipients, for example, polyethylene glycols, fats, for example, cacao fat and higher esters (for example, C 14 -alcohol with C 16 -fatty acid), or mlxtures of these substances. Ointments, pastes, creams and gels can contain, in addition to the active compounds, the customary excipients, for example, animal and vegetable fats, waxes, paraffins, starch tragacanth, cellulose derivatives, polyethylene glycols, silicones, bentonites, silicic acid, talc and zinc oxide, or mixtures of these substances. Dusting powders and sprays can contain, in addition to the active compounds, the customary excipients, for example, lactose, talc silicic acid, aluminum hydroxide, calcium silicate and polyamide powder, or mixtures of these substances. Sprays can additionally contain customary propellants, for example, chlorofluorohydrocarbons. Solutions and emulsions can contain, in addition to the active compounds, customary excipients, such as solvents, solubilizing agents and emulsifiers, for example, water, ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butylene glycol, dimethylformamide, oils, in particular, cottonseed oil, groundnut oil, corn germ oil, olive oil, castor oil and sesame oil, glycerol, glycerol formal, tetrahydrofurfuryl alcohol, polyethylene glycols and fatty acid esters of sorbitan, or mixtures of these substances. For parenteral administration, the solutions and emulsions can also be in a sterile form which is isotonic with blood. Suspensions can contain, in addition to the active compounds, customary excipients, such as liquid diluents, for example, water, ethyl alcohol or propylene glycol and suspending agents, for example ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum methydroxide, bentonite, agar-agar, and tragacanth, or mixtures of these substances. The abovementioned pharmaceutical formulations can also contain other pharmaceutical active compounds in addition to the claimed compounds of the present invention. The aforementioned pharmaceutical formulations are prepared in the customary manner by known methods, for example, by mixing the active compound or compounds with the excipient or excipients. The formulations mentioned can be used either with humans and animals, orally, rectally, bucally parenterally (intravenously, intramuscularly or subcutaneously), intracisternally, intravaginally, intraperitoneally or locally (dusting powder, ointment or drops) and for the therapy of infection in hollow spaces or body cavities. Suitable formulations are injection solutions, solutions and suspensions for oral therapy, gels, pour-on formulations, emulsions, ointments or drops. Ophthalmological and dermatological formulations, silver salts and other salts, ear drops, eye ointments, powders or solutions can be used for local therapy. It is furthermore possible to use gels, powders dusting powders, tablets sustained release tablets, premixes, concentrates, granules, pellets, capsules, caplets, aerosols, sprays and inhalates on humans and animals. The compounds according to the invention can furthermore be incorporated into other carrier materials, such as, for example, plastics (e.g., chains of plastic for local therapy), collagen or bone cement. The synthesis of the preferred embodiments of the compounds of the present invention will now be described with reference to the following non-limiting examples: EXAMPLE 1 N-(Methyl-2-Carboxyethyl)-Proline-t-Butyl Ester. ##STR7## To a solution of triethylamine (12.1 mL;3.0 eq.) in THF (30 mL) was added methyl bromoacetate (3.29 mL;1.2 eq.). Next a solution of S-proline t-butyl ester (4.96g;29.0 mmol) in THF (15 mL) was added dropwise with stirring. A white precipitate formed and the mixture was stirred for 15 h at room temperature. The reaction mixture was partitioned between saturated sodium bicarbonate solution (I00 mL) and ethyl ether (lOOmL). The organic layer was drawn off and the aqueous layer was extracted with ethyl ether (2×50 mL). The combined organics were dried over MgSO 4 , filtered and stripped of solvent. The residual oil was distilled in vacuo (b.p. 120° C. at 0.05 torr) to give product as a clear oil (6.82 g;97%). 1 H-NMR (300 MH 2 ) δ 3.72 (s,3H), 3.63 (d,J=17.0 Hz,1H), 3.48 (d,J=17.0 Hz,1H), 3.45 (dd,J=8.0,6.5Hz,1H), 3.14 (m,1H), 2.75 (m,1H), 2.15 (m,1H), 1.85 (m,3H), 1.44 (s,9H). 13 C-NMR (75.6 MHz) δ 173.5, 172.0, 81.2, 64.8, 54.0, 53.3, 52.0, 30.0, 28.6, 24.1. EXAMPLE 2 (2S, 3S) N-[methyl 2-(3-benzylamino-5-methyl-hexanoyl)1-Proline-t-Butyl Ester and (2R, 3R) N-[methyl 2-(3-benzylamino-5-methyl-hexanoyl)1-Proline-t-Butyl Ester ##STR8## To a solution of N-benzyl-isovaleryl amine (3.79 g;1.3 eq) in THF (60 mL) at -78° C. was added BF 3 .OEt 2 (3.31 mL;1.6 eq.), the mixture was stirred at -78° C. for 5 min then was warmed to room temperature for about 45 min. In a separate flask, a solution of N-(Methyl-2-Carboxyethyl)-Proline-t-Butyl Ester (4.09 g;16.8 mmol) in THF (60 mL) was cooled to -78° C. and a solution of LiHMDS (25.3 mL;1.0M in THF;1.5 eq.) was added by syringe. After about 35 min the N-benzyl-isovaleryl imine/BF 3 .OEt 2 the mixture was slowly added to the enolate solution by cannula. The mixture was stirred for about 15 min at -78° C. and then was warmed to room temperature for 6 h. The reaction was quenched with saturated NH 4 Cl (75 mL) solution. The reaction mixture was partitioned between ethyl ether (75 mL) and water (75 mL). The organic layer was drawn off and the aqueous layer was extracted with ethyl ether (2×50 mL). The combined organic phases were dried over MgSO 4 , filtered and stripped to give a yellow oil. Careful preparative chromatography on silica gel with hexane: ethyl acetate yielded samples of the pure (R,R) and (S,S) diastereomers and mixed fractions. The first material off of the column was the (S,S) diastereomer (0.565 g;8%); then came mixed fractions and finally pure (R,R) diastereomer (4.84 g;64%). 2a (S,S) diastereomer 1 H-NMR(300 MHz) δ 7.27 (m,5H), 3.77 (ABq,J=12.7,3.7 Hz,2H), 3.70 (s,3H), 3.62 (d,J=8.4 Hz,1H), 3.41 (dd,J=8.3,5.5 Hz,1H), 3.06 (m,1H), 2.95 (dd,6.8,6.2 Hz,2H), 2.00-1.76 (m,5H), 1.59-1.36 (m,3H), 1.46 (s,9H), 0.95 (d,J=6.7 Hz,3H), 0.87 (d,J=6.4 Hz,3H). 13 C-NMR (75.6 MHz) δ 174.1, 173.4, 141.8, 128.9, 128.8, 127.4, 81.1, 67.4, 65.2, 56.1, 52.2, 51.6, 48.0, 42.7, 30.0, 28.8, 28.5, 24.9, 24.7, 22.4. 2b:(R,R) diastereomer 1 H-NMR (300 MHz) δ 7.28 (m,5H) 3.85-3.70 (m,3H), 3.68 (s,3H), 3.14 (m,1H), 2.97 (m,1H), 2.84 (m,1H), 2.14 (m,1H), 1.80 (m,5H), 1.42 (s,9H), 1.25 (m,2H), 0.90 (d,J=6.6 Hz,3H), 0.81 (d,J=6.6 Hz,3H). 13 C-NMR (75.6 MHz) δ 175.8, 174.1, 141.6, 128.9, 128.8, 127.4, 80.9, 67.1, 62.3, 56.3, 53.5, 52.1, 51.7, 42.4, 32.0, 28.7, 25.6, 24.4, 24.3, 22.7. EXAMPLE 3 (2S, 3S) N-[methyl 2-(3-amino-5-methyl-hexanoyl)1-Proline-t-Butyl Ester ##STR9## The (S,S) diastereomer from Example 2a (0.467 g;1.11 mmol) was dissolved in ethyl acetate (40 mL) in a 500 mL Parr shaker bottle and Pd(OH) 2 (66 mg) was added. The mixture was agitated under an atmosphere of H 2 gas (60 psi gauge) overnight. The mixture was filtered through a pad of Celite and stripped to give an oil suitable for use without further purification (0.378 g;100%). 1 H-NMR (300 MHz) δ 3.71 (s,3H), 3.42 (dd,J=8.3,5.0 Hz,1H), 3.30 (d,J=7.9 Hz,1H), 3.09 (m,1H), 2.94 (m,1H), 2.75 (m,1H), 1.98-1.74 (m,4H), 1.60 (m,3H), 1.45 (s,9H), 1.13 (m,1H), 0.95 (d,J=6.6 Hz,3H), 0.89 (d,J=6.5 Hz,3H). EXAMPLE 4 2R, 3R) N-[methyl 2-(3-amino-5-methyl-exanoyl)1-Proline-t-Butyl Ester ##STR10## The (R,R) diastereomer from Example 2b (3.24 g;7.74 mmol) was dissolved in ethyl acetate (50 mL) in a 500 mL Parr shaker bottle and Pd(OH) 2 (0.325 g) was added. The mixture was agitated under an atmosphere of H 2 gas (60 psi gauge) overnight. The mixture was filtered through a pad of Celite and stripped to give an oil suitable for use without further purification. 1 H-NMR (300 MHz) δ 3.75 (dd,J=8.9,1.5 Hz,1H), 3.70(s,3H), 3.40 (d,J=5.8 Hz,1H), 3.11 (m,2H), 2.83 (m,1H), 2.12 (m,1H), 1.91-1.73 (m,4H), 1.58 (br s,2H), 1.43 (s,9H), 1.30 (m,1H), 1.12 (m,1H), 0.91 (d,J=6.7 Hz,3H), 0.86 (d,J=6. Hz,3H). 13 C-NMR (75.6 MHz) δ 175.0, 173.1, 81.1, 70.5, 62.3, 52.4, 51.9, 50.5, 44.4, 31.2, 28.7, 25.4, 24.4, 23.9, 22.2. EXAMPLE 5 (2S, 3S) N-[methyl 2-(3-carbobenzyloxyamino-5-methyl-hexanoyl) -Proline-t-Butyl Ester ##STR11## To a solution of the (S,S) diastereomeric free amine from Example 3 (0.287 g;0.87 mmol) in THF (10 mL) at 0° C. was added triethylamine (0.61 mL);5.0 eq.) and then benzyl chloroformate (0.25 mL;2.0 eq.) by syringe. The reaction mixture was slowly warmed to room temperature and stirred 15 h. The resultant mixture was partitioned between ethyl ether (20 mL) and saturated sodium bicarbonate solution (20 mL). The organic layer was drawn off and the aqueous layer was extracted with ethyl ether (2×10 mL). The combined organics were dried over MgSO 4 , filtered and stripped to give a yellow oil. The oil was purified by silica gel chromatography with 10.1 hexane:ethyl acetate to yield the product as a clear oil (0.263 g:6.5%). 1 H-NMR (300 MHz) δ 7.32 (m,5H), 5.49 (d,J=9.6 Hz,1H), 5.13 (d,J=12.4 Hz,1H), 5.04 (d,J=12.4 Hz,1H), 4.15 (m,1H), 3.65 (s,3H), 3.59 (d,J=6.0 Hz,1H), 3.49 (m,1H), 2.97 (m,2H}, 2.04 (m,1H), 1.87-1.66 (m,4H), 1.43 (s,9H), 1.41-1.23 (m,2H), 0.97 (d,J=6.3 Hz,3H), 0.91 (d,J=6.7 Hz,3H). 13 C-NMR (75.6 MHz) δ 174.3, 172.4, 156.9, 137.5, 129.0, 128.6, 128.5, 81.4, 67.4, 67.1, 66.0, 52.0, 50.9, 49.4, 43.3, 30.4, 28.7, 25.5, 25.2, 24.4, 22.3. EXAMPLE 6 (2R, 3R) N-[methyl 2-(3-carbobenzyloxyamino-5-methyl-hexanoyl)]-Proline-t-Butyl Ester ##STR12## To a solution of the (R,R) diastereomeric free amine from Example 4 (0.644 g;1.96 mmol) in THF (10 mL) at 0° C. was added triethylamine (0.82 mL;3.0 eq.) and then benzyl chloroformate (0.42 mL;1.5 eq.) by syringe. The reaction mixture was slowly warmed to room temperature and stirred 15 h. The resultant mixture was partitioned between ethyl ether (20 mL) and saturated sodium bicarbonate solution (20 mL). The organic layer was drawn off and the aqueous layer was extracted with ethyl ether (2×10 mL). The combined organics were dried over MgSO 4 , filtered and stripped to give a pale oil. The oil was purified by silica gel chromatography with 12:1 hexane:ethyl acetate to yield the product as a clear oil (0.480 g:53%). 1 H-NMR (300 MHz) δ 7.33 (m,5H), 5.96 (d,J=9.9 Hz,1H), 5.12 (s,2H), 4.21 (m,1H), 3.79 (dd,J=9.3,1.7 Hz,1H), 3.69 (s,3H), 3.68 (d,J=3.9 Hz,1H), 3.09 (m,1H), 2.80 (q,J=7.9H.sub., 1H), 2.19 (m,1H), 1.93 (m,1H), 1.89-1.59 (m,3H), 1.45 (s,9H),1.27-1.04 (m,2H), 0.92 (d,J=6.4 Hz,3H), 0.87 (d,J=6.7 Hz,3H). 13 C-NMR (75.6 MHz) δ 175.7, 172.8, 157.1, 137.6, 129.0, 128.6, 128.5, 81.4, 67.4, 67.1, 62.4, 54.1, 52.2, 50.1, 42.4, 31.9, 28.7, 25.7, 24.1 (degenerate), 22.3. EXAMPLE 7 (2S, 3S) N-[methyl 2-(3-carbobenzyloxyamino-5-methyl-hexanoyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR13## To a solution of the (S,S) diastereomeric diester from Example 5 (0.263 g;0.568 mmol) in CH 2 Cl 2 (0.25 mL) was added trifluoroacetic acid (2.50 mL) and the resultant solution was stirred overnight. The volatiles were removed in vacuo and the residue was dissolved in DMR (5.0 mL). To the resultant solution isoleucine N-benzyl amide (0.316 g;2.5 eq.), HOBt(0.195 g;2.5 eq.) and ethyl morpholine (0.435 mL;6.0 eq.) were added in succession. The mixture was cooled to 0° C. and EDCI (0.514 g;3.0 eq.) was added and dissolved. The mixture was slowly warmed to room temperature and stirred 15 h. Again the volatiles were removed in vacuo. The residue was partitioned between CH 2 Cl 2 (15 mL) and saturated sodium bicarbonate solution (25 mL). The aqueous layer was extracted with CH 2 Cl 2 (2×5 mL) and the combined organic phases were dried over MgSO 4 , filtered and stripped. The residue was purified by chromatography on silica gel with 2:1 hexane:ethyl acetate to give a white foam (0.217 g;63%). 1 H-NMR (300 MHz) δ 7.80 (d,J=9.5 Hz,1H), 7.29 (m,5H), 6.67 (br s,1H), 5.12 (d,J=12.2 Hz,1H), 5.00 (d,J=9.1 Hz,1H), 4.99 (d,J=12.2 Hz,1H), 4.40 (d,J=5.7 Hz,2H), 4.26 (dd,J=9.3,7.1 Hz,1H), 4.12 (m,1H), 3.60 (s,3H), 3.51 (dd,J=9.6,4.0 Hz,1H), 3.34 (d,J=7.2 Hz,1H), 2.92 (m,2H), 2.11-1.85 (m,3H), 1.79 (m,2H), 1.64 (m,2H), 1.54-1.35 (m,3H), 1.08(m,1H), 0.92 (m,12H). 13 C-NMR (75.6 MHz) δ 175.5, 171.9, 171.6, 156.8, 139.0, 137.3, 129.3, 129.1, 128.8 (degenerate), 128.4, 128.0, 67.9, 67.5, 67.3, 58.4, 52.1, 51.6, 49.0, 44.1, 42.2, 37.3, 31.7, 25.7, 25.6, 25.3, 24.3, 22.2, 16.5, 11.9. EXAMPLE 8 (2R, 3R1 N-[methyl 2-(3-carbobenzyloxyamino-5-methyl-hexanoyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR14## To a solution of the (R,R) diastereomeric diester from Example 6 (98.5 mg;0.213 mmol) in CH 2 Cl 2 (0.10 mL) was added trifluoroacetic acid (1.00 mL) and the resultant solution was stirred overnight. The volatiles were removed in vacuo and the residue was dissolved in DMF (2.5 mL). To the resultant solution isoleucine N-benzyl amide (0.105 g;2.2 eq.), HOBt (66.7 mg;2.2 eq.) and ethyl morpholine (0.165 mL;6.0 eq.) were added in succession. The mexture was cooled to 0° C. and EDCI (0.162 g;2.5 eq.) was added and dissolved. The mixture was slowly warmed to room temperature and stirred 8 hrs. Again the volatiles were removed in vacuo. The residue was partitioned between CH 2 Cl 2 (25 mL) and saturated sodium bicarbonate solution (10 mL). The aqueous layer was extracted with CH 2 CI2 (2×5 mL) and the combined organic phases were dried over MgSO 4 , filtered and stripped. The residue was purified by chromatography on silica gel with 3:1 hexane:ethyl acetate to give a pale foam (0.110 g;85%). 1 H-NMR (300 MHz) δ 7.93 (d,J=9.5 Hz,1H), 7.47-7.17 (m,l1H), 5.78 (br s,1H), 5.22 (d,J=12.4 Hz,1H), 5.02 (d,J=12.4 Hz,1H), 4.44 (d,J=5.5 Hz,2H), 4.33 (dd,J=9.7,5.0 Hz,1H), 4.16 (m,1H), 3.63 (d,J=4.0 Hz,1H), 3.49 (s,3H), 3.38 (m,2H) 2.60 (m,1H), 2.17 (m,2H), 2.05 (m,1H), 1.88-1.51 (m,3H), 1.44 (m,1H), 1.00 (m,2H), 0.86 (m,12H). 13 C-NMR (75.6 MHz) δ 6 175.9, 173.1, 172.2, 157.0, 138.8, 137.3, 129.2 (degenerate), 128.9, 128.7, 128.5, 127.9. 69.8, 67.3, 65.5, 58.7, 55.4, 52.6, 50.9, 44.4, 41.8, 36.9, 32.5, 25.5, 25.2, 25.0., 23.9, 22.2, 16.7, 12.2. EXAMPLE 9 (2S, 3S) N-[2-(3-carbobenzyoxyamino-5-methylhexan-1-olyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR15## To a solution of the (S,S) diastereomeric product from Example 7 (16.9 mg;0.0278 mmol) in THF (2.0 mL) was added LiBH. (7.1 mg; excess) and the mixture was stirred overnight. The reaction was quenched with water (2 mL) and extracted with CH 2 Cl 2 (3×5 mL). The combined extracts were dried over MgSO 4 , filtered and stripped. Careful preparative chromatography on silica with CH 2 Cl 2 : methanol gave the product (4.8 mg;30%) as a white solid. 1 H-NMR (300 MHz) δ 7.86 (d,J=9.2 Hz,1H), 7.21-7.39 (m,10H), 6.59 (br s,1H), 5.14 (d,J=9.2 Hz,1H), 5.08 (d,J=12.2 Hz,1H) 4.66 (d,J=9.9 Hz,1H), 4.38 (m,2H), 4.19 (dd,J=9.4,7.1 Hz,1H) 4.08 (m,1H), 3.92 (m,1H), 3.73 (m,1H), 3.61 (m,1H), 3.54 (m,1H), 3.18 (m,1H), 3.01 (m,1H), 2.34 (m,1H), 2.18 (m,1H), 1.80-1.97 (m,3H) 1.76-1.60 (m,2H), 1.47 (m,2H), 1.10 (m,1H), 0.92 (m,12H). EXAMPLE 10 2R, 3R) N-[2-(3-carbobenzoxyamino-5-methyl hexan-1-olyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR16## To a solution of the (R,R) diastereomeric product from Example 8 (22.5 mg;0.037 mmol) in THF (2.5 mL) was added LiBH 4 (6.2 mg;excess) and the mixture was stirred 35 min. The reaction was quenched with water (3 mL) and stirred overnight. The mixture was partitioned between water (mL) and CH 2 Cl 2 (10 mL). The aqueous phase was extracted with CH 2 Cl 2 (3×5 mL). The combined oranic phases were dried over MgSO 4 , filtered and stripped. The residue was chromatographed on silica with 3:2 hexane:ethyl acetate to give product (19.2 mg;94%) as a white solid. 1 H-NMR (300 MHz) δ 8.39 (d,J=8.3 Hz,1H), 7.34-7.21 (m,10H), 6.73 (br s,1H), 6.58 (d,J=9.3 Hz,1H), 5.66 (m,1H), 5.17 (d,J=l2.5 Hz,1H), 5.04 (d,J=12.5 Hz,1H), 4.51 (dd,J=I4.8,6.0 Hz,1H), 4.33 (dd,J=14.8, 5.2 Hz,1H), 4.15 (m2H), 3.85 (dt,J=13.2,2.3 Hz,1H) 3.57 (dd,J=I3.2, 6.2 Hz,1H), 3.32 (m,1H) 3.22 (m,1H), 2.48 (m,1H), 2.24 (m,1H), 2.08 (m,1H), 1.94 (m,1H), 1.85-1.51 (m,5H), 1.42 (m,1H), 1.28 (m,1H), 1.09 (m,1H), 0.99 (d,J=6.5 Hz,3H), 0.95 (d,J=6.5 Hz,3H), 0.85 d,J=6.7 Hz,3H), 0.75 (t,J=7.4 Hz,3H). 13 C-NMR (75.6 MHz) δ 176.9, 173.7, 157.1, 138.2, 138.0, 129.5, 129.1, 128.6, (degenerate), 128.4, 128.2, 66.7 (degenerate), 66.0, 61.2, 58.8, 52.9, 51.1, 44.5, 44.0, 37.7, 31.7, 25.4 (doubly degenerate), 25.3, 23.8, 22.9, 15.4, 11.4. EXAMPLE 11 (2S, 3S) N-[methyl 2-(3-(N-carbobenzyloxy-β-cyano-alanv11 amino-5-methyl-hexanoyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR17## (2S, 3S) N-[methyl 2-3-(N-carbobenzyloxy-asparaginyl) amino-5-methyl-hexanoyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR18## The (S,S) diastereomeric product from Example 7 (191 mg;0.281 mmol) was dissolved in MeOH (10 mL) and 10% palladium on carbon (20 mg) was added. The mixture was stirred under an atmosphere of H 2 gas (10 psi gauge) overnight. The mixture was filtered through a pad of Celite and the solvent was stripped in vacuo to give the product as an oil suitable for use without purification. 1 H-NMR (300 MHz) δ 8.36 (br d,J=6.8, Hz,1H), 7.70 (br s,1H), 7.24 (m,5H), 4.80 (very broad s,2H), 4.37 (dd,J=14.9,6.2 Hz,1H), 4.27 (t,J=8.6 Hz,1H), 4.14 (dd,J=14.9,5.0,1H), 3.63 (s,3H), 3.55 (m,1H), 3.43 (br s,1H), 3.26 (m,2H), 2.90 (m,1H), 2.14 (m,2H), 1.84 (m,4H), 1.55 (m,2H), 1.27-1.05 (m,2H), 0.92 (d,J=6.6 Hz,3H), 0.85 (m,9H). 13 C-NMR (75.6 MHz) 176.6, 173.0, 171.2, 138.8, 129.1, 128.3, 127.8, 68.4, 68.0, 59.1, 52.2, 50.9, 50.2, 43.9, 42.4, 36.3, 32.0, 26.2, 25.9, 25.3, 24.4, 21.5, 16.3, 11.3. The oil was dissolved in DMF (1.5 mL) and S-carbobenzyoxy-asparagine (81.5 mg;1.05 eq.) HOBt(41.6 mg;1.05 eq.) and ethyl morpholine (110 μL;3.0 eq.) were added in succession. The mixture was cooled to 0° C. and EDCI (102.0 mg;1.2 eq.) was added and dissolved. The mixture was warmed slowly to room temperature and stirred 15 h. The volatiles were removed in vacuo and the residue was partitioned between CH 2 Cl 2 (10 mL) and saturated sodium bicarbonate solution (5 mL). The aqueous phase was extracted with CH 2 Cl 2 (2×5 mL) and the combined organics were dried over MgSO 4 , filtered and stripped. The residue was chromatographed on silica with 40:1 CH 2 Cl 2 :methanol to give the β-cyano alanyl adduct (44.6 mg;20%) as a pale oil. Continued elution with 30:1 CH 2 Cl 2 :methanol gave the asparaginyl adduct (117 mg;51%) as a white solid. 11a: β-cyano alanyl adduct: 1 H-NMR (300 MHz) 7.72 (d,J=9.3Hz,1H), 7.35-7.21 (m,10H), 7.16 (d,J=9.2Hz,1H), 6.99 (br s, 1H), 5.99 (d,J=7.9Hz,1H) 5.10 (s,2H), 4.55-4.32 (m,5H), 3.68 (s,3H), 3.47 (m,2H), 3.02 (m,1H), 2.91 (m,1H), 2.80 (d,J=6.1 Hz,2H), 2.10 (m,1H), 1.94-1.41 (m,8H), 1.08 (m,1H), 0.91 (m,12H). 13 C-NMR (75.6 MHz) 175.4, 172.2, 171.8, 168.7, 156.3, 138.6, 136.5, 129.3, 129.2, 129.0, 128.8, 128.3, 128.1, 117.4, 68.2, 68.0 (degenerate), 58.0, 52.4, 51.8, 49.8, 49.7, 44.2, 41.9, 38.1, 31.6, 25.8, 2.5, 25.4, 24.4, 22.0, 21.8, 16.5, 11.9. 11b: Asparaginyl adduct: 1 H-NMR (300 MHz) 7.74 (d,J=9.2 Hz,1H), 7.35-7.20 (m,10H), 7.14 (d,J=9.6 Hz,1H), 7.03 (t,J=5.8 Hz,1H) 6.44 (d,7.9 Hz,1H), 6.41 (br s, 1H), 5.73 (br s,1H), 5.09 (ABq,J=12.4,3.7 Hz,2H), 4.51-4.25 (m,4H), 3.64 (s,3H), 3.45 (m,2H), 2.98 (m,2H), 2.80 (dd,J=15.4,4.7 Hz,1H), 2.52 (dd,J=15.4,6.0 Hz,1H), 2.09 (m,1H), 1.98 (m,1H), 1.82 (m,2H), 1.71-1.35 (m,5H) 1.09 (m,1H), 0.89 (m,12H). 13 C-NMR (75.6 MHz) 175.1, 173.4, 171.9 (degenerate), 171.4, 156.9, 139.1, 136.4, 129.7, 129.6, 129.0., 128.9, 128.6, 128.2, 67.9, 67.8, 67.3, 58.5, 52.1, 51.9, 49.6, 49.1, 44.1, 42.2, 37.4, 37.3, 31.7, 25.5, 25.4, 25.1, 24.2, 21.9, 16.2, 11.7. EXAMPLE 12 (2S, 3S) N-[2-(3-(N-carbobenzyloxy-asparaginyl)amino-5-methyl hexan-1-olyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR19## To a solution of the (S,S) diastereomeric asparaginyl adduct from Example 11b (10.2 mg;0.0141 mmol) in THF (300 μL) was added LiBH 4 (5.0 mg;excess) and the mixture was stirred 7 h. The reaction was quenched with water (4 mL) and extracted with CH 2 Cl 2 (3×2 mL). The combined extracts were filtered through glass wool and stripped. The residue was chromatographed on silica with CH 2 Cl 2 :methanol to give product (6.2 mg;63%) as a white solid. 1 H-NMR (300 MHz) δ 8.03 (d,J=9.5 Hz,1H), 7.30 (m,10H), 7.02 (t,J=5.5 Hz,1H), 6.88 (d,J=9.0 Hz,1H), 6.33(d,J=7.OHz,1H), 6.29 (br s,1H), 5.75 (br s,1H) 5.08 (s,2H), 4.52 (m,1H), 4.43 (d,J=5.5 Hz,1H), 4.31 (m,3H), 4.18 (dd,J=9.5,6.5 Hz,1H), 3.68 (br d,J=11.5 Hz,1H), 3.56 (br d,J=11.5 Hz,1H), 3.49 (m,1H), 3.06 (m,2H), 2.78 (dd,J=13.5, 3.5 Hz,1H), 2.54 (dd,J=13.5,7.0 Hz,1H), 2.15 (m,1H), 1.89 (m,3H), 1.68-1.36 (m,5H), 1.10 (m,1H), 0.90 (m,12H). 13 C-NMR (75.6 MHz) δ 177.4, 173.7, 172.8, 171.8, 156.6, 138.2, 136.6, 129.4, 129.3, 128.9, 128.8, 128.4, 128.2, 67.6, 65.2, 62.7, 60.6, 58.6, 52.2, 51.4, 47.6, 44.3, 43.5, 38.0, 37.4, 3255, 25.6, 25.3, 25.2, 24.4, 22.1, 16.8, 11.9. EXAMPLE 13 (2S. 3S N-[methyl 2-(3-(N-asparaginyl)amino-5-methyl-hexanoyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR20## To a solution of the (S,S) diastereomeric product from Example 11b (101.3 mg;0.140 mmol)in methanol (5.0 mL) was added 10% palladium on carbon (10 mg). The mixture was stirred under an atmosphere of Hz gas (10 psi gauge) overnight. The mixture was filtered through a pad of Celite and stripped to give a solid. The product was chromatographed on silica with CH 2 Cl 2 :methanol to give the product (80.1 mg;97%) as a white solid. 1 H-NMR (300 MHz) δ 8.15 (br s,1H), 7.62 (br s,2H), 7.24 (m,5H), 6.86 (br s,1H), 5.44 (very broad s,3H), 4.50 (m,1H), 4.32 (m,2H), 4.16 (m,2H), 3.65 (s,3H), 3.44 (m,3H), 3.08-2.64(m,4H), 2.10-1.34 (m,9H), 1.00 (m,1H), 0.88 (m,12H). EXAMPLE 14 (2S, 3S) N-methyl 2-(3-(N-guinaldyl-asparaginyl)amino-5-methyl-hexanoyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR21## To a solution of the (S,S) diastereomeric free amine from Example 13 (80.1 mg;0.136 mmol) in DMF (600 μL) were successively added quinaldic acid (26.2 mg;1.1 eq.). HOBt (20.5 mg;1.1 eq.) and ethyl morpholine (52 μL;3.0 eq.). The reaction mixture was cooled to 0° C. and EDCI (48.7 mg;1.2 eq.) was added and dissolved. The mixture was slowly armed to room temperature and stirred for 15 h. The volatiles were removed in vacuo and the residue was partitioned between CH 2 Cl 2 (10 mL) and saturated sodium bicarbonate solution (10 mL). The aqueous phase was extracted with CH 2 CI 2 (2×5 mL) and the combined organics were filtered through glass wool and stripped to give a paste. The paste was chromatographed on silica with 40:1 CH 2 Cl 2 :methanol to give product (89.9 mg;89%) as a white solid. 1 1 H-NMR (300 MHz) δ 9.33 (d,J=7.9 Hz,1H), 8.19 (d,J=8.5 Hz,1H), 8.13 (d,J=117. Hz,1H), 8.10 (d,J=11.7 Hz,1H), 7.78 (m 2H), 7.70 (td,J 7.6,1.2 Hz,1H), 7.58 (m,2H), 7.33 (br s,1H), 7.18 (m,5H) 6.80 (br s,1H), 6.05 (br s,1H), 4.98 (m,1H), 4.47-4.24 (m,4H), 3.63 (s,3H), 3.49 (d,J=7.7 Hz,1H), 3.44 (dd,J=9.4,3.4 Hz,1H), 3.01 (m,3H), 2.70 (dd,J=15.7,6.6 Hz,1H), 2.12-1.37 (m,9H), 1.05 (m,1H), 0.86 (m,12H). 13 C-NMR (75.6 MHz) δ 175.7, 174.1, 172.0, 171.9, 171.2, 165.4, 149.7, 147.2, 139.0, 138.1, 130.8, 130.7, 130.0, 129.1, 128.8, 128.3 (degenerate), 127.8, 119.3, 67.5, 67.0, 58.2, 52.3, 50.9, 49.4, 48.8, 44.0, 42.2, 37.9, 37.5, 31.7, 25.6, 25.5, 24.4, 22.2, 16.5, 11.9. EXAMPLE 15 (2S, 3S) N-guinaldyl-asparaginyl)amino-5-methyl hexan-1olyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR22## To a solution of the (S.S) diastereomeric product from Example 14 (33.5 mg;0.0541 mmol) in THF (1.0 mL) was added LiBH 4 (5.0 mg; excess) and the mixture was stirred 4 h. The reaction was quenched with water (4 mL) and stirred overnight. The mixture was diluted with water (4 mL) and extracted with CH 2 Cl 2 (5×4 mL). The combined extracts were dried over MgSO 4 , filtered and stripped. The residue was chromatographed on silica with CH 2 Cl 2 :methanol to give product (18.4 mg;57%) as a white solid. 1 1 H-NMR (300 MHz) δ 9.26 (d,J=7.9 Hz,1H), 8.23 (d,J=8.3 Hz,1H), 8.17 (d,J=8.3 Hz,1H), 8.13 (dd,J=8.1,0.6 Hz,1H), 8.05 (d,J=9.3 Hz,1H), 7.82 (dd,J=8.3,0.8 Hz,1H), 7.73 (ddd,J=8.5,6.9,1.5 Hz,1H), 7.59 (ddd,J=8.1,6.8,1.4, Hz,1H), 7.39 (t,J=5.7 Hz,1H), 7.31-7.18 (m,11H), 6.54 (br s, 1H), 6.10 (br s, 1H), 5.03 (m,1H), 4.51-4.21 (m,5H), 3.76 (br d,J=11.8 Hz,1H), 3.59 (m,2H), 3.60 (m,2H), 2.93 (dd,J=15.4,4.6 Hz,1H), 2.76 (dd,J=15.4,7.9 Hz,1H), 2.66 (m,1H), 2.17 (m,1H), 1.86 (m,3H), 1.67-1.43 (m,5H), 1.08 (m,1H), 0.87 (m,12H). 13 C-NMR (75.6 MHz) δ 177.3, 173.9, 172.7, 171.6, 165.3, 149.7, 147.2, 138.7, 138.1, 130.8, 130.7, 130.0, 129.3, 128.8, 128.4, 128.3, 128.1, 119.3, 65.2, 62.8, 60.7, 58.5, 51.0, 50.8, 47.7, 44.1, 43.3, 38.3, 37.4, 32.5, 25.5, 25.3, 25.2, 24.3, 22.2, 16.6, 11.8. EXAMPLE 6 (2R, 3R) N-[2 (3-(N-guinaldyl-asparaginyl) amino-5-methyl-hexanoate)]-Prolyl-Isoleucine N-Benzyl amide ##STR23## The (R,R) diastereomeric product from Example 8 (23.9 mg;0.0393 mmol) was dissolved in MeOH (1.0 mL) and 10% palladium on carbon (2.0 mg) was added. The mixture was stirred under an atmosphere of H 2 gas (5 psi gauge) overnight. The mixture was filtered through a pad of Celite and the solvent was stripped in vacuo to give the product as an oil. The oil was chromatographed on silica with 40:1 CH 2 Cl 2 :methanol to give recovered starting material (3.7 mg). Further elution with 10:1 CH 2 CI 2 :methanol gave product (14.0 mg;89%) as an oil. 1 H-NMR (300 MHz) δ 8.27 (br s,1H), 7.53 (br s,1H), 7.26 (m,5H), 4.45 (d,J=5.5 Hz,2H), 4.33 (m,1H), 3.52 (s,3H), 3.38 (m,3H), 3.24 (br s,1H), 2.49 (m,1H), 2.37 (m,1H), 2.06 (m,2H), 1.80 (m,3H), 1.50 (m,1H), 1.11 (m,3H), 0.90 (m,12H). 13 C-NMR (75.6 MHz) δ 176.0, 172.3, 171.7, 129.2, 128.8, 127.9, 71.9, 66.2, 58.7, 54.3, 52.5, 50.7, 44.1, 42.6, 36.1, 32.2, 25.2, 25.1 (degenerate), 23.5, 22.4, 16.9, 11.9. The free amine (13.1 mg;0.028 mmol) was dissolved in DMF (200 μL) and S-N-quinaldyl-asparagine (10.8 mg;1.2 eq.), HOBt (4.7 mg;1.2 eq.) and ethyl morpholine (10.6 μL;3.0 eq.) were added in succession. The mixture was cooled to 0° C. and EDCI (13.5 mg;1.5 eq.) was added and dissolved. The mixture was warmed slowly to room temperature and stirred 15 h. The volatiles were removed in vacuo and the residue was partitioned between CH 2 Cl 2 (2 mL) and saturated sodium bicarbonate solution (2 mL). The aqueous phase was extracted with CH 2 Cl 2 (3×2 mL) and the combined organics were filtered through glass wool and stripped. Careful preparative chromatography followed by recrystallization from ethyl acetate gave product (9.9 mg;48%) as a white solid. 1 H-NMR (300 MHz) δ 9.12 (br d,J=7.6 Hz,1H), 8.33 (br d, J=9.3 Hz,1H), 8.27 (d,J=8.5 Hz,1H), 8.17 (d,J=8.5 Hz,1H), 8.16 (d,J=8.4 Hz,1H), 7.99 (d,J=7.8 Hz,1H), 7.86 (dd,J=7.4,0.8 Hz,1H), 7.76 (ddd,J=8.5,7.0,1.5 Hz,1H), 7.62 (ddd,J=8.0,7.0,1.1 Hz,1H), 7.39-7.22 (m,6H), 6.50 (br s,1H), 5.44 (br s,1H), 5.22 (m,1H), 4.56 (dd,J=14.9,6.3 Hz,1H), 4.43 (m,1H), 4.30 (m,2H), 3.96 (d,J=4.2 Hz,1H), 3.62 (s,3H), 3.61 (m,1H), 3.22 (m,1H), 2.93 (m,2H), 2.70 (m,1H), 2.27 (m,1H), 1.98 (m,3H), 1.83-1.52 (m,4H) 1.23-1.05 (m,3H), 0.85 (m,12H). 13 C-NMR (75.6 MHz) δ 177.1, 173.6, 173.0, 172.3, 171.5, 165.4, 149.7, 147.3, 138.4, 138.0 (degenerate), 130.8, 130.0, 129.3, 128.8, 128.4, 128.2, 128.1, 119.1, 67.6, 64.7, 58.9, 56.1, 52.3, 51.5, 50.3, 44.4, 40.6, 39.6, 36.9, 33.1, 25.9, 25.8, 24.9, 24.0, 22.0, 16.5, 11.4. EXAMPLE 17 (2R, 3R) N-[2-(3-(N-guinaldyl-asparaginyl) amino-5-methyl hexan-1-olyl)]-Prolyl-Isoleucine N-Benzyl amide ##STR24## To a solution of the (R,R) diasteromeric produce from Example 16 (5.4 mg; 7.3 μmol) in THF (500 μL) was added LiBH 4 (2.0 mg;excess) and the mixture was stirred for about 1 h. The reaction was quenched with water (500 μL) and stirred overnight. The mixture was extracted with CH 2 Cl 2 (3×600 μL). The extracts were stripped and the residue was purified on silica with CH 2 Cl 2 :methanol to give the product (3.8 mg;70%) as an oil. 1 H-NMR (300 MHz) δ 9.32 (d,J=8.0 Hz,1H), 8.55 (d,J=7.4 Hz,1H), 8.29 (d,J=8.4 Hz,1H), 8.23 (d,J=8.4 Hz,1H), 8.17 (d,J=8.6 Hz,1H), 7.91 (br d,J=7.6 Hz,1H), 7.85 (dd,J=8.1,1.1 Hz,1H), 7.71 (ddd,J=8.4, 6.9,1.4 Hz,1H), 7.60 (ddd,8.0,6.9,1.2 Hz,1H), 7.28 (m,5H), 6.70 (br s,1H), 6.29 (br s,1H), 5.68 (br s,1H), 4.96 (br s,1H), 4.85 (br s,1H), 4.35 (m,3H), 4.14 (m,1H), 3.75 (br d,12.4 Hz,1H), 3.57 (br d,J=12.4 Hz,1H), 3.27 (br d,J=10.2 Hz,1H), 3.21 (m,1H), 3.09 (dd,J=15.9,4.9 Hz,1H), 2.78 (dd,J=15.9,6.3 Hz,1H), 2.53 (m,1H), 2.37 (m,1H), 2.08 (m,1H), 1.91 (m,2H), 1.82-1.48 (m,4H), 1.41-1.14 (m,3H), 0.97-0.83 (m,12H). 13 C-NMR (75.6 MHz) δ 177.4, 173.6, 173.3, 170.6, 165.4, 149.8, 147.3, 138.1 (degenerate), 130.9, 130.7, 130.1, 129.5, 128.7, 128.4, 128.2 (degenerate), 119.4, 66.7, 66.1, 61.3, 59.0, 51.2 (degenerate), 49.4, 44.4, 43.2, 38.4, 36.8, 31.9, 26.1, 25.5, 25.4, 24.0, 22.8, 16.5 11.5. Following synthesis, the preferred embodiment compounds were tested for HIV protease inhibition. For in vitro potency testing, the N terminus of substrate amino acid sequences were first dansylated. The amino acid sequences present in such N-dansyl-peptide substrates can include, but are not limited to native proteolytic cleavage site sequences for the HIV gag and pol polyproteins. The prepared substrates were incubated with HIV protease and compounds of the present invention, under conditions in which the protease is catalytically active. Control incubate mixtures did not have the inhibitor compounds. Following incubation, aliquots of the incubate were analyzed with reverse phase high performance liquid chromatography (hereinafter "RP-HPLC"). Any uncoverted peptide substrate is resolved from peptide product(s) and then detected by an inline fluorescence monitor. The amount of product formed over a known time interval may then be used to calculate the activity of the enzyme under the specific assay conditions. The amount of fluorescence detected in the eluted peak from HPLC can be related to the amount of peptide in the peak by prior HPLC analysis of standardized samples. The amount of peptide in the pure, standardized samples is determined accurately by amino acid analysis. EXAMPLE 18 Inhibitory Potency Testing Inhibitory potency was assessed, in vitro, according to published procedures in Tamburini et al., 1990, "A Fluorometric Assay for HIV-Protease Activity Using High-Performance Liquid Chromatography", Analytical Biochemistry, 186:363. HIV-protease was pre-incubated with or without the inhibitor compound at 37° C. and under buffer, ionic strength and pH conditions affording optimal protease activity. An N-dansyl-peptide substrate was then added to the incubation mixture. For example the dansylated substrate could be: N-Dansyl-Ser-Gln-Asn-Tyr-Pro-Ile-Val (SEQ ID NO: 1) The incubation mixture was then incubated at 37° C. During the incubation, the substrate is cleaved by the protease at the Tyr-Pro peptide bond to yield N-Dansyl-Ser-Gln-Asn-Tyr (SEQ ID NO: 2). At the end of the incubation (40 min) the reaction was terminated by acidification with TFA, and the amounts of unconverted substrate and fluorescent product were detected and quantified by subsequent RP-HPLC analysis with post column fluorescence detection. The rate of cleavage of the substrate is quantified from the amount of product formed in the known incubation time. Specific assay conditions were as follows: Incubations (75 ul) containing the complete system without substrate were preincubated at 37° C. for 15 min prior to initiation of the protease reaction by the addition of 25 ul of stock 400 uM substrtate peptide solution. The initial component concentrations at the start of the reaction were: HIV-protease (20 ul of a dilution sufficient to produce 40 to 60% substrate cleavage in 40 min), dimethyl sulphoxide (5%v/v), N-Dansyl-Ser-Gln-Asn-Tyr- -Pro-Val-Ile-Val (SEQ ID NO: 1) (100 uM), and sodium chloride (3 M) in 150 mM mes buffer pH 6.0. After a further incubation time of 40 min at 37° C. reactions were terminated by the addition of 50 ul of 12% (v/v) tri-flouroacetic acid, and then loaded into the HPLC autosampler for analysis. Inhibitors were added to the incubation mixtures io to protease addition before the preincubation, as stock solutions in dimethyl suphoxide, lower concentrations of inhibitor were obtained by serial dilution of the incubation mixture containing the highest inhibitor concentration. The range of inhibitor concentrations were designed to cover the range yielding zero to 100% inhibition of protease activity. Dilution of the HIV-protease activity (so as to achieve an amount of enzyme activity in 20 ul to produce 40 to 60% substrate conversion when added to the incubation) was achieved using the following buffer: 50 mM sodium acetate buffer pH 5.2, 50 mM sodium chloride, 20 mM DL-dithiothreitol, 20% (v/v) glycerol, 0.1% (v/v) triton X-100 and 1.5 M urea. Analytical RP-HPLC was performed on Hewlett-Packard HP 1090 complete with binary solvent delivery, heated column compartment, and auto-injector. Fluorescence detection was achieved with an in-line Gilson model 121 filter fluorometer (excitation at 310 to 410 nm, emission at 480 to 520 nm) in conjunction with an HPLC chem station (DOS series) and software for data analysis. Aliquotes (usually 10 ul) of acidified incubation mixture containing both the unconverted substrate and proteolytic products were separated on a Hypersil (VYDAC) ODS, 5 uM column (4.6×100 mm). N-dans-Ser-Gln-Asn-Tyr-Pro-Ile-Val (SEQ ID NO: 1) and N-dans-Ser-Gln-Asn-Tyr (SEQ ID NO: 2) were resolved isocratically in 100 mM sodium acetate buffer, pH 6.5, containing 29% (v/v) acetonitrile, at a flow rate of 1.2 ml/min, and column temperature of 50° C. Quantification of the flourescent peptides was performed using peak areas. Calculation of IC 50 values For each incubation, the fraction (f) of the substrate converted to product was calculated. Since all incubations were performed for the same incubation time (t), the relative values of (f) for the incubations yielded the same relationship as the apparent reaction rates (V), given by (V=f/t). The (f) values were then subject to analysis using a modification of the Dixon plot (Segel, 1975, Enzyme Kinetics, Wiley-Interscience Publications, New York) of the form f(-I)/f(+I) versus inhibitor concentration (I), where f(-I) and f(+I) are the fraction of product formed in the absence and presence respectively of an inhibitor concentration equal to (I). IC 50 values were calculated from the reciprocal slope of the plots which were in each case found to be linear. Results Table I, below, lists the results of inhibition potency tests for the compounds of the present invention measured both in the absence and presence of several concentrations of the compound. Initial screens were performed at 10 μM final inhibitor concentration. Compounds exhibiting significant activity at 10 μM were titrated with varying inhibitor concentrations (I) to determine apparent IC 50 values. TABLE I______________________________________HIV Protease IC.sub.50 values of tested ExamplesCompound of Example No: IC.sub.50 (nM)______________________________________Example 7 NIExample 8 NIExample 9 1900Example 10 NIExample 11a NIExample 11b 15000*Example 12 125Example 14 >50000*Example 15 35Example 16 NIExample 17 15000*______________________________________ NI = no inhibition at 10 μM final concentration. *Estimated IC.sub.50 from the observed inhibition at 10 μM concentration. Assays for each inhibitor concentration (including 0 nM) were in all cases performed in triplicate. TABLE II______________________________________Compound of IC.sub.50.sup.a Inhibitor.sup.cExample No: (nM) n.sup.b (nM) CV %.sup.d______________________________________ 7 NI* 1 10000 -- 8 NI 1 10000 -- 9 1900 7 50 to 10000 0.0710 NI 1 10000 -- 11a NI 1 10000 -- 11b 15000.sup.f 1 10000 --12 125 7 1 to 500 1.9614 >50000.sup.f 1 10000 --15 35 6 1 to 100 1.8816 NI 1 10000 --17 15000.sup.f 1 10000______________________________________ where: .sup.a IC.sub.50 is the concentration of compound in the in the assay incubation which inhibits the HIVprotease activity by 50% under the specified assay conditions. .sup.b n is the number of inhibitor concentrations analysed (including 0 nM) .sup.c the range of inhibitor concentrations tested (besides 0 nM). .sup.d CV % = Percentage standard deviation for the linear Dixon plots = 100 X (standard deviation for the slope/calculated slope) .sup.e NI = no inhibition. .sup.f estimated from the % inhibition at 10000 nM final. As shown by the low CV % values in Table II, excellent quality titration data were obtained in each case. Thus: 1) Direct comparison of compounds differing only in the stereochemistry within the substituted amino-5-methyl hexan-1-olyl isostere group (i.e., compounds of Examples 9 versus 10; Examples 15 versus 17) showed that only compounds of the 2S,3S stereochemistry gave significant inhibitory potency. Corresponding compounds containing the 2R,3R stereochemistry were innactive or poorly active (compounds of Examples 10 and 17). All three compounds showing significant inhibitor potency (compounds of Examples 9, 12 and 15) possessed the 2S,3S stereochemistry. The activity of compounds of Examples 12 and 15 are within the range necessary for therapeutic development. 2) Comparison of compounds containing the hexan-1-olyl group and hexanoate group within the isostere spacer (compare compounds of Examples 7 versus 9, 11 versus 12, or 14 versus 15) showed that only compounds with 2S,3S isostere spacer stereochemistry plus a free hexan-1-olyl group had significant activity. 3) The compounds of Examples 9 and 12 differ only in that the latter compound (compound 12) contains an additional Asn residue between the carbo-benzyloxy and isostere spacer group. Addition of this amino acid increased inhibitory potency by 152 fold. 4) Substitution of the N-carbo-benzyloxy group with the N-quinaldehyde group (compare compounds of Examples 12 and 15) increased inhibitory potency 3.6 fold. This is less than has been observed with other isostere spacers. Collectively, the most important determinant of inhibitory potency of compounds based on the isostere spacer type of the present invention is the novel nature of the isostere group itself. Within the spacer the 2S,3S stereochemistry yields active compounds but it is possible that that compounds containing either the 2S 3R or 2R,3S isostere spacer stereochemistry might yield improved potency. As shown hereinabove, the third important determinant of the potency is the nature of the substituents both N- and C-terminal to the isostere group. It will be appreciated that the instant specification and claims are set forth by way of illustration and not limitation and that various modifications and changes may be made without departing from the spirit and scope of the present invention. __________________________________________________________________________SEQUENCE LISTING(1) GENERAL INFORMATION:(iii) NUMBER OF SEQUENCES: 2(2) INFORMATION FOR SEQ ID NO:1:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 7 amino acids(B) TYPE: amino acid(C) TOPOLOGY: linear(ii) PUBLICATION INFORMATION:(A) AUTHORS: Ratner et al.(B) JOURNAL: Nature (C) VOLUME: 313(D) PAGES: 277(E) DATE: 1985(iii) SEQUENCE DESCRIPTION: SEQ ID NO:1:SerGlnAsnTyrProIleVal15(2) INFORMATION FOR SEQ ID NO:2:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 4 amino acids(B) TYPE: amino acid (C) TOPOLOGY: linear(ii) PUBLICATION INFORMATION:(A) AUTHORS: Ratner et al.(B) JOURNAL: Nature(C) VOLUME: 313(D) PAGES: 277(E) DATE: 1985(iii) SEQUENCE DESCRIPTION: SEQ ID NO:2:SerGlnAsnTyr

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of the filing of U.S. Provisional Patent Application Ser. No. 60/700,862, entitled “Physical Context Management for an Automobile”, filed on Jul. 20, 2005, and the specification thereof is incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT The Government has rights to this invention pursuant to Contract No. DE-AC04-94AL85000 awarded by the U.S. Department of Energy. INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC Not Applicable. COPYRIGHTED MATERIAL © 2005-2006 Sandia Corporation. A portion of the disclosure of this patent document and of the related application listed above contains material that is subject to copyright protection. The owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyrights whatsoever. BACKGROUND OF THE INVENTION 1. Field of the Invention (Technical Field) The present invention relates to methods, computer software, and apparatuses for determining conditions affecting operation of a motor vehicle. 2. Description of Related Art During driving, as in many real-world tasks, humans engage in multitasking such as talking on the telephone, following instructions, and responding to requests. The present invention provides a system that minimizes the impact of untimely interruptions by providing a physical context to the driving conditions. By mitigating unnecessary tasks during periods of high difficulty, one can improve both driving, by minimizing hazards to safety, and the ability to successfully complete extraneous tasks. For example, talking on a mobile phone increases the likelihood of a traffic accident about 400%, depending on driving difficulty, which is a similar rate to intoxicated driving. A system that, for instance, delayed mobile phone calls during potentially difficult driving situations, such as merging onto a high-speed roadway, could drastically reduce the accident rate, while delaying those important conversations by a short time. The first step toward realizing such a system is the ability to correctly identify potentially difficult driving conditions. BRIEF SUMMARY OF THE INVENTION The present invention is of computer software for and a method of enhancing safety for an operator of a motor vehicle comprising: employing a plurality of sensors of vehicle and operator conditions; matching collective output from the sensors against a plurality of known dangerous conditions; and preventing certain activity of the operator if a known dangerous condition is detected. In the preferred embodiment, matching employs a nonlinear dynamical system. One embodiment matches against a plurality of conditions known a priori but as determined from a plurality of test subjects experiencing simulations of those conditions and from the sensor data received during recording of those simulations. Preferably an optimal solution of a learning algorithm of the nonlinear dynamical system has been calculated and in the matching step false negatives are substantially reduced in the calculation of an optimal solution via a method such as gradient-descent or genetic algorithm. The known conditions can alternatively be determined automatically from collected sensor data of those conditions and from concomitant human-scored difficulty estimates. In this case, unsupervised learning is preferably employed from collected sensor data of those conditions and from concomitant human-scored difficulty estimates. This preferably involves matching against a plurality of known conditions as determined via unsupervised learning employing linear regression of a 2*N dimensional vector of sensor input from N sensors. The operator can then make difficulty estimates concerning current conditions, which estimates are then incorporated into the matching step. Prevented activities can include employing a telephone, listening to audio programs, listening to high-volume audio programs, and employing vehicle interior lighting. Objects, advantages and novel features, and further scope of applicability of the present invention will be set forth in part in the detailed description to follow, taken in conjunction with the accompanying drawings, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS The accompanying drawings, which are incorporated into and form a part of the specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating one or more preferred embodiments of the invention and are not to be construed as limiting the invention. In the drawings: FIGS. 1( a ) and ( b ) are graphical representations of the preferred basic functions of a first embodiment of the invention; FIG. 2 is a graph of the results of a gradient descent and genetic algorithm for estimating the correct situation; the error bars indicate the 99% confidence interval; FIG. 3 is a graph of the results of the gradient descent and genetic algorithm for estimating the weighted correct situation; the error bars indicate the 99% confidence interval; FIG. 4 is a diagram of training the difficulty classifier of a second embodiment of the invention; FIG. 5 illustrates taking a temporal signal, focusing on the regression window; FIG. 6 shows the regression coefficients from FIG. 5 ; the cross marks the coefficients from the regression window in FIG. 5 ; and FIG. 7 is a two-dimensional representation of a clustering example. DETAILED DESCRIPTION OF THE INVENTION The present invention is of classification systems, methods, and computer software to identify driving situations from labeled examples of previous occurrences. The purpose of the classifier is to provide physical context to a separate system that mitigates unnecessary distractions, allowing the driver to maintain focus during periods of high difficulty. In one embodiment, while watching videos of driving, different users were asked to indicate their perceptions of the current situation. A classifier was trained to emulate the human recognition of driving situations. In unstructured conditions, such as driving in urban areas and the German autobahn, the classifier was able to correctly predict human perceptions of driving situations over 95% of the time. The second embodiment advances the first in the following ways: It eliminates the need to determine a priori the useful contexts. The second embodiment automatically identifies the salient patterns, or “contexts” in the data. Since the contexts are automatically identified from the data itself, the system can be redeployed quickly to new operating environments (e.g., transitioning from on-road to off-road conditions). As a corollary, the second embodiment eliminates the concern about which contexts to identify. For example, are developers not identifying a context that could be potentially useful? This question is eliminated as the second embodiment automatically finds the statistical regularities in the data. Using the first embodiment, difficulty estimates were conducted in an ad hoc manner. The new system allows one to construct optimal difficulty estimates using the contexts as inputs and human-generated estimates of perceived difficulty as the ground truth. The difficulty estimator then minimizes the error between its predictions and those of the human. The first embodiment also did not allow adaptation to new users. The classifier was created from a set of training data, and is thereafter a static system. The second embodiment allows automatic adaptation to new users. The first embodiment of the invention is next described in detail. The test vehicle for experiments employed with the first embodiment of the invention was a Mercedes-Benz S-Class sedan, equipped with specialized sensors for the present research. The vehicle supplies a wide range of physical data such as speed, turn signals, etc. The posture of the driver is measured by a pressure-sensitive chair and ultrasonic six-degree-of-freedom head-tracking system, both developed by the University of Pittsburgh. Several hours of data were collected in unstructured driving conditions in both urban areas and on the German autobahn. Humans were also asked humans to label videos of these driving runs according to a list of potential situations. Consequently, the high-level goal of the work was to predict the time-series of human-recognized situations using the various sensors as input. To this end, the Sandia Cognitive Framework (SCF) as described in C. Forsythe and P. G. Xavier, “Human emulation: Progress toward realistic synthetic human agents,” in Proceedings of the 11 th Conference on Computer - Generated Forces and Behavior Representation , 2002, was employed to integrate the information of the driver posture and vehicle state to estimate the current driving situations. The pattern-recognition component of SCF is a type of Nonlinear Dynamical System (NDS). The present invention comprises the learning algorithms used to tune the parameters of the NDS to recognize driving situations. A series of experiments was conducted to ascertain the most useful situations to provide the mitigation strategy with the appropriate driving context. As the goals of the mitigation strategy evolved, its information requirements changed accordingly. For example, during what driving situations would a driver least desire to receive a mobile phone call? Conversely, during what driving situations does a mobile phone call least impact safety? The questions were repeated for each extraneous task that the driver may encounter. In this manner, a list of potentially useful situations were identified and, in later stages, superfluous situations were removed from the list. After several iterations, the remaining situations are assumed to be the minimum set needed to perform the desired classifications and demonstrate an operational performance gain by mitigating extraneous tasks during difficult driving conditions. When the classifier of the invention indicates that the driving context is no longer difficult, mitigation ends and the vehicle operates normally. Typically, the driver is unaware that the system proactively intervened on her behalf. Five human subjects were instructed to drive on a predefined circuit of German roads measuring about 200 km, ranging from urban streets to the autobahn, and each subject made three runs of the circuit. No modifications were made to the roadways or the ambient driving conditions, such as traffic or road construction. Data from the vehicle and driver posture were sampled at a rate of four Hertz. From these data-collection experiments, a total of almost 24 hours of data (343,946 samples) was obtained. In addition to the sensor streams, a wide-angle video camera was also used to capture a driver-like perspective out the front of the vehicle. In order to use supervised learning to classify the data according to driving situations, it is first necessary to obtain ground-truth labels. As mentioned earlier, candidate situations were vetted by the information required by the mitigation strategy. After several iterations, the following situations were decided to be the most useful: (1) Approaching or Waiting at Intersection; (2) Leaving Intersection; (3) Entering On-ramp or High-Speed Roadway; (4) Being Overtaken; (5) High Acceleration or Dynamic State of Vehicle; (6) Approaching Slow-Moving Vehicle; (7) Preparing to Change Lanes; and (8) Changing Lanes. To generate the labels, a tool was created that displayed to the human labeler the frontal video as well as a set of check-boxes, one for each of the eight candidate driving situations. The human labeler indicated their perception of the current driving situation by checking and unchecking the appropriate boxes. The tool also allowed the user to rewind, pause, save, load, and correct previously labeled time periods. After the user completed the labeling of a video segment, a zero-order hold was performed to associate a label with each input sample. This resulted in a sequence of binary vectors, {x* 0 , . . . , x* N } where └x* n ┘ i =1 if the ith situation was active at time n, and └x* n ┘ i =0 otherwise. Two users generated labels for each of the five driver subjects for each of their three circuits, for a total of 15 labeled data sets. Formulated as a supervised-learning problem, a goal of the first embodiment of the present invention was to find an “optimal” mapping from a time-series of sensory inputs to a time-series of driving-situation labels. Since a goal of the invention is human centric, deriving a classifier that emulates the human recognition of driving situations, the Sandia Cognitive Framework (SCF) was employed. From an engineering perspective, the situation-recognition component of SCF is a type of Nonlinear Dynamical System (NDS). The inputs to the NDS are the processed sensory inputs, described above. The outputs of the NDS are estimated activation levels of the various situations as a function of time. The estimated situation activations can be considered a trajectory through the state space of the NDS. It is preferred to use the ordered sequence of labels, described above, as the groundtruth targets for a learning algorithm. From this formulation, the goal of a supervised-learning algorithm is to tune the parameters of the NDS to minimize the error between the estimated situations and the ground-truth situations generated by the human labelers. To derive the preferred learning algorithm, one needs a few elementary functions and notation. One writes the (i,j)th entry of a matrix as [A] i,j and the ith entry of a vector as [x] i . The Heaviside step function is defined as H α ⁡ ( x ) = { 0 , x < α 1 , otherwise . One approximates the threshold-linear function as {tilde over (τ)} α ( x )= x ( H α ( x )+ψ H −α ( −x )),  (1) where ψ ∈ (0,1) is some small, positive constant to ensure that its derivative is nonzero. In the experiments, the setting was typically 0.01. For convenience, write τ ~ α ′ ⁡ ( x ) = ⅆ ⅆ x ⁢ τ ~ α ⁡ ( x ) . The piecewise-continuous compression function used in the SCF is defined as f L ⁡ ( x ) = { x , 0 ⁢ < _ ⁢ x ⁢ < _ ⁢ L L ⁢ ⁢ log e ⁢ xe L , otherwise . ( 2 ) Note that Equation 2 has a continuous derivative that is nonzero everywhere, except as x→∞. In the experiments, one typically set L=3. For convenience, write f L ′ ⁡ ( x ) = ⅆ ⅆ x ⁢ f L ⁡ ( x ) . Equation 1 and Equation 2 are both more easily demonstrated in graphical form and are shown in FIGS. 1 ( a ) and ( b ). Define the tristate function as ϑ α , β ⁡ ( x ) = { 0 , x < α 1 , x > β - 1 , α ⁢ < _ ⁢ x ⁢ < _ ⁢ β where α<β. In the experiments, one typically set α=0.4 and β=0.6. Let the vector of inputs at time n be r n ∈ d , where d is the number of sensors. Let the vector of estimated activation levels of the situations at time n be {circumflex over (x)} n ∈ c , where c is the number of situations to classify. The dynamical equations are u n ={tilde over (τ)} 60 ( r n ) y n =A{circumflex over (x)} n−1— ƒ L ( Bu n ), {circumflex over (x)} n =ƒ L ({tilde over (τ)} β ( y n ))  (3) where A is the (c×c) matrix of feedback weights, and B is the (c×d) matrix of feedforward weights. From a high-level perspective, the general form of Equation 3 implies that the current driving situations are a function of previous driving situations and the current sensor inputs. Except in trivial cases, there does not exist a closed-form optimal solution for the parameters of Equation 3, given a sequence of known sensor inputs and desired output trajectory. Therefore, any learning algorithm will rely on iterative procedures to compute locally optimal estimates of A and B. To minimize the error between the ground-truth labels and the estimated labels from Equation 3, one may pursue two different approaches. The first uses a gradient-descent approach and the second uses a Genetic Algorithm (GA) formulation. According to the human labelers, the majority of the time (52%) during the experiments, none of the target situations occurred. The most common driving situation, “Begin Overtaken,” occurs 28% of the time, while the rarest situation, “Entering On-ramp or High-Speed Roadway,” occurs less than 1% of the time. Given this imbalanced data set, a typical least-squares estimation procedure, such as regression, will tend to generate only false negatives because it can achieve 99% accuracy by simply classifying “Not Entering On-ramp.” By raising the “punishment” for misclassifying rare situations, a system will be forced to learn the causes of those rare, but important, events. One can do this by weighting the samples inversely proportional to how frequently they occur, one of several well-established approaches to the “rare-event problem”. With such a weighting scheme, incorrectly classifying a time sample as “Entering On-ramp” (false positive) results in the error being weighted by 0.01, whereas missing a classification of “Entering On-ramp” (false negative) results in an error weight of 0.99. This has the effect of minimizing the number of false negatives, which is important in designing a system that mitigates against potentially difficult, though infrequent, driving situations. Let N be the total number of labeled samples gathered during the experiments. Let N i be the number of samples where the ith situation was “active,” according to the ground-truth labels. Define the weighting function as ω ⁡ ( x i * ) = { 1 - N i N , x i * = 1 N i N , x i * = 0 ( 4 ) In the experiments, it was found that a classifier performs much better when incorporating this weighting scheme. This is because it is impossible for a system classifying situations based solely on their relative frequency to achieve better than 50% correct when weighting classifications by Equation 4. One preferably chooses error similar to that of large-margin classification, where learning focuses on finding the most constraining vectors to shatter a training set. Consider that an estimated situation is correct if it is “near” the target label, i.e., if the tristate value of the estimated situation equals the target label, α,β ({circumflex over (x)} i )=x* i . Define the error between the label for the ith situation as ɛ ⁡ ( x i * , x ^ i ) = { 0 , ϑ α , β ⁡ ( x ^ i ) = x i * ω ⁡ ( x i * ) ⁢ ( x i * - x ^ i ) , otherwise . ( 5 ) The supervised-learning formulation is finding the parameter matrices A and B from Equation 3 that minimize the sum-squared error ( A ^ * , B ^ * ) = argmin ( A , B ) ⁢ 1 2 ⁢ ∑ n = 0 N - 1 ⁢ ⁢   ɛ ⁡ ( x n * , x ^ n )   2 . ( 6 ) Both the gradient descent and the genetic algorithm seek locally optimal solutions to Equation 6. In the gradient-descent formulation, one seeks to minimize the error measure between the target and estimated labels by tuning the parameters according to the gradient of the error. To do this, one needs the gradients of Equation 5 with respect to the parameters of Equation 3, namely the feedback matrix A and the feedforward matrix B. At time n, let the estimated situation activation for the ith situation be [{circumflex over (x)} n ] i from Equation 3 and let the corresponding ground-truth label be └{circumflex over (x)}* n ┘ i . The gradient of the error measure with respect to the feedforward weights at time n for the ith situation label is then ∂ ∂ [ A ] i , j ⁢ 1 2 ⁢   ɛ ⁡ ( [ x n * ] i , [ x ^ n ] i )   2 = { 0 , ⁢ ϑ α , β ⁡ ( [ x ^ n ] i ) = [ x n * ] i - ω ⁡ ( [ x n * ] i ) ⁢ ( [ x n * ] i - [ x ^ n ] i ) ⁢ ∂ ∂ [ A ] i , j i ⁡ [ x ^ n ] i , otherwise One must now apply the chain rule several times and, skipping some lengthy steps, one receives the following result: ∂ [ x ^ n ] i ∂ [ A ] i , j = f L ′ ⁡ ( τ ~ β ⁡ ( [ y n ] i ) ) ⁢ τ β ′ ⁡ ( [ y n ] i ) ⁢ ( [ x ^ n - 1 ] j + [ A ⁢ ∂ x ^ n - 1 ∂ [ A ] i , j ] i ) . ( 7 ) To compute the full gradient, it is necessary to vary the indices (i and j) over all possibilities. The derivation of the feedforward weights is similar to Equation 7, the result being: ∂ [ x ^ n ] i ∂ [ B ] i , j = f L ′ ⁡ ( τ ~ β ⁡ ( [ y n ] i ) ) ⁢ τ β ′ ⁡ ( [ y n ] i ) ⁢ ( [ A ⁢ ∂ x ^ n - 1 ∂ [ B ] i , j ] i + f L ′ ⁡ ( [ Bu n ] i ) ⁡ [ u n ] j ) . ( 8 ) Note that both Equation 7 and Equation 8 use the gradient from the previous time step, which could lead to unstable updates as the error accumulates. Various researchers in the field of adaptive control have identified sufficient conditions to ensure that gradient-descent update rules yield stable estimates. The pseudo-code for the preferred gradient-descent algorithm is shown below, where {x* 0 , . . . , x* N } is the sequence of target labels, {r* 0 , . . . , r* N } is the sequence of sensor inputs, η ∈ (0,1) is the step size, and σ>0 is the stopping criterion. ν:=∞ while ν>σ ν:=0 for all r n ∈{r 0 , . . . , r N } Compute {circumflex over (x)} n as Equation 3 Δ A := ∂ ∂ A ⁢ 1 2 ⁢   ɛ ⁡ ( [ x n * ] i , [ x ^ n ] )   2 as Equation 7 Δ B := ∂ ∂ B ⁢ 1 2 ⁢   ɛ ⁡ ( [ x n * ] i , [ x ^ n ] )   2 as Equation 8 A:=A−ηΔ A B:=B−ηΔ B ν:=ν+∥Δ A ∥ F +∥Δ B ∥ F end for all end while It can be shown that the algorithm and update rules are stable, and consequently guaranteed to converge and terminate at a local minimum, if the step size η is decayed in the standard manner. For the genetic algorithm embodiment, the DAKOTA optimization package was employed to create a Genetic Algorithm (GA) to find locally optimal solutions for the parameters of the dynamical system in Equation 3. The genome is preferably simply a column-stacked vector of the feedforward and feedback matrices, y=vec([A;B]). The fitness criterion for a given parameterization was the error measure between all ground-truth and estimated labels, as in Equation 6, which is the same as the gradient-descent formulation. Between generations, keep the N best genomes and the stochasticity is preferably handled solely by genome mutations, as crossover was not allowed for. The genome mutations were selected by sampling from a Gaussian distribution centered about the keeper genome from the previous generation, y (i+1) ˜N(y (i) ,Σ). The covariance matrix, Σ, was determined by hand a priori to contain reasonable values. The driving data was divided into a training set (18.3 hours) and a test set (5.6 hours). Each of the five subjects drove the roadway circuit three times. Each driver had two circuits randomly assigned to the training set and one to the test set. Both the gradient-descent and genetic-algorithm formulations were run on these data sets. In every performance statistic that was measured, the gradient-descent algorithm outperformed the genetic algorithm. FIG. 2 shows the performance in absolute percentage correct. The gradient-descent algorithm predicted the human recognition of driving situations over 95% of the time on the test set, while the GA managed about 85% correct. As mentioned earlier, a most important statistic in measuring the success of the algorithms is the weighted percentage correct (Equation 4). FIG. 3 shows the performance in weighted percentage correct. When weighting the classification score by Equation 4, the gradient-descent algorithm predicted human recognition of driving situations about 88% of the time on the test set, while the GA managed about 84% correct. The gradient-descent algorithm is also much more efficient at finding a solution than the GA. On the 18.3 hours driving data in the training set, the gradient descent algorithm typically converged in about one hour of computation time and 101 parameter evaluations. The GA, on the other hand, averaged 1611 hours (about 67 days) of computation time and 50,013 evaluations. The relative efficiency of the gradient-descent algorithm is due to the massive amount of problem-specific knowledge incorporated into the algorithm—the gradient of the error. Since this information is not incorporated into the GA, it is not surprising that it used substantially more parameter evaluations to arrive at a locally optimal solution. However, even when the GA was given the solution of the gradient-descent algorithm as its initial genome, the GA was unable to improve performance after several machine-days of computation. The identification and extraction of patterns from observed data goes back to ancient times, and pattern recognition is now a necessary capability in many fields. Researchers are still developing novel methods to identify and extract patterns from large amounts of data. Other researchers are interested in identifying contexts, or situations, in response to human behavior to improve system performance, with applications in computing and mobile phones. Incorporating pattern recognition to assist humans in vehicle driving has a relatively long history in robotics, most notably the Navlab project at Carnegie-Mellon University. In order to simplify the process of writing control software, the Navlab project quickly started using supervised-learning algorithms based on observations gained while humans drove the target vehicle. In the present invention, learning algorithms were employed to estimate the optimal parameters of a nonlinear dynamical system. Broadly speaking, estimating the parameters of a dynamical system that minimize some cost function is known as optimal control. There has been a substantial amount of work in nonlinear systems, though finding optimal solutions to most nonlinear systems is generally intractable. While one is able to write down the gradient of the system with respect to the tunable parameters and derive stable update equations, this is usually quite cumbersome and time consuming. This is the reason that general stochastic optimization techniques, such as genetic algorithms, are often used to solve for the unknown optimal parameters. While the experiments herein compared the performance of a designed gradient-descent algorithm to a standard genetic-algorithm formulation, there are a large number of other techniques to classify time-series data that could be employed with the present invention, including recurrent neural networks and hidden Markov models. The second embodiment of the invention is next described. The manner by which the contexts are generated in the second embodiment of the invention uses an approach called “unsupervised learning.” The form of unsupervised learning that is preferred attempts to find regularities in the data. This is done by first transforming temporal sensory signals into a high-dimensional vector. It is preferred to use linear regression to fit a straight line to a temporal signal over a predefined time window, shown in FIG. 5 , resulting in regression coefficients shown in FIG. 6 . The slope (m) and offset (b) values are two coordinates in a vector space. For N sensors, this regression approach yields a 2*N dimensional vector. The preferred unsupervised learning algorithm searches for “clusters” in this high-dimensional vector space, as shown in FIG. 7 . One of the assumptions of this work is that regularities in this vector space are caused by underlying physical contexts. For example, entering an onramp will result in the driver accelerating, putting on a turn signal, and looking over her shoulder. It is this type of regularity that the second embodiment's algorithm captures. Once the classifier is constructed, and new sensory data are being input into the system, one estimates the vector-space parameters from the regression mentioned above, using a buffer to keep the data on hand. The classifier estimates the probability that the vector-space parameters were generated by each of the k clusters. This probability distribution is the output of the classifier. To perform difficulty classification, as shown in FIG. 4 , one obtains a time series of difficulty estimates from a human, and these human-scored difficulty estimates are analog (e.g., 0-100) and are diagnostic of the context classifier. To estimate the “optimal” difficulty classifier, one takes the time series of context probabilities from the unsupervised context classifier as input and the human-scored difficulty estimates as ground truth. One then estimates a cognitive model (using the approach described in the first embodiment) that optimally predicts the human perception of difficulty, also on an analog scale of, e.g., 0-100, using the context probabilities as input. To adapt a system to a new user, suppose one has a context classifier constructed from the approach mentioned above that is constructed from the data of a group of people for which we have human-scored difficulty estimates. Then a new user, for whom we do not have difficulty estimates, begins driving the vehicle. In the second embodiment one can adapt the previously constructed context classifier to the unique driving style of this new user. As data from the new user becomes available, simply add these to the training set mentioned above and run the unsupervised-learning algorithms to update the locations of the contexts, resulting in an adapted context classifier. One then uses the probability distributions from the adapted classifier to estimate a new optimal difficulty classifier using only the inputs and outputs for which one has human-scored difficulty estimates. While such an approach may initially sound costly, it can be computed in real time in parallel with the regular operation of the context classification. The present invention, in either embodiment, may be conjoined with a motor vehicle and concomitant sensor inputs in a variety of hardware implementations. For example, the data processing can be performed by an appropriately programmed microprocessor, Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA), or the like, in conjunction with appropriate memory and bus elements. The methods of the invention can be implemented by appropriate software coded in C++, Java, microcode, etc., as understood by one of ordinary skill in the art. Although the invention has been described in detail with particular reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents. The entire disclosures of all references, applications, patents, and publications cited above are hereby incorporated by reference.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a checkerlike game embodying a game board having board magnets therein and movable game pieces having piece magnets therein and involves interactions between the board magnets and the piece magnets. 2. Description of the Prior Art It is known to place bar magnets and magnetic pieces in permanently closed boxlike structures. Structures exist wherein laterally spaced magnets have their poles orthogonal to a permanently closed housing. This is exemplified by magnetic credit cards and the techniques developed for their manufacture. See U.S. Pat. No. 3,651,312 issued on Mar. 21, 1972 to W. W. Barney. Barney does not disclose a housing which can be reopened. Moreover, Barney does not address the problem of reprogramming the positions of a plurality of magnets with respect to a fixed peripheral geometry for the housing, a credit card. As known, a magnetic game comprises a flat board having a SINGLE playing surface and checkerlike playing pieces. The board is square and is divided into a plurality of playing squares in a checkerboard fashion with squares arranged in rows, columns, and diagonals. Alternate diagonals of squares are colored differently. One set of alternate diagonals of squares, the playing squares, has under EACH square a bar magnet with either an N-pole or an S-pole proximate to the playing surface. Players of a game on this board having found games less and less interesting and appealing as the game is repeated because they tend to learn the relative positions of opposite polarity squares of the board. This information is acquired when a piece is not repelled by one square but is repelled by another. See U.S. Pat. No. 2,819,904 issued on Jan. 14, 1958 to W. M. Nelson et al. Such games, as known, are played with cylindrical playing pieces which have two flat surfaces. These pieces have magnets imbedded therein without regard or reference to a color difference on the flat surfaces. Each magnet has an S-pole and an N-pole. In one portion of the playing pieces, the S-poles are adjacent first colored surfaces. In a remaining portion, the N-poles are adjacent first colored surfaces. The board, as known, is flat and has a magnet located under each square which is used for playing. One symmetric portion of the board, for example, the alternate diagonals, is used for play. This portion may be colored red, for example, and an unplayable portion may be colored black, for example. The board magnets are located under each square with either an S-pole or an N-pole adjacent thereto. The S-poles and N-poles are arranged in a symmetric pattern. See U.S. Pat. No. 2,819,904 supra. One problem with this arrangement is that when a face of the cylindrical playing piece of one polarity lands on a square having underneath a pole of the same polarity the piece is not only repelled but is either translocated to another square or to its curved wall. Thus, the player must manually flip over the playing piece. This is an annoying inconvenience which substantially slows the pace of the game. Another problem with the game as known is the permanent site of each individual magnet in the board. This lack of flexibility and lack of programmability for the board reduces the commercial value of the game. What is needed is a variation of this game wherein the degree of skill necessary to play the game may be selected by selection of a particular program for the board, i.e., a pattern for the various combinations of S-poles and N-poles of board magnets which may be placed adjacent a surface of the board. Flexibility in programming is not itself the only problem to be solved. A means is needed to quickly change the pattern of the board without the necessity of rearranging individual magnets within the board. An automatic or semi-automatic means is needed for changing the pattern. Considerable consumer interest is expressed for those games wherein several elements of a game or toy are remotely changed by one manual movement. SUMMARY OF THE INVENTION The inventions are a means for automatically flipping the playing pieces of the game, the means comprising spherical balls and spherical cavities in the playing squares; a game board having a magnet pattern which is changeable by reorienting the board; and a game board having a magnet pattern which is changeable by removing, adding, translocating, and flipping individual magnets therein. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a perspective view of a novel playing piece for this invention; FIG. 2 is a fragmented perspective view of the novel playing piece of this invention; FIG. 3 is a fragmented perspective view of a novel playing board of this invention; and FIG. 4 is a partial cross section taken along the line 50--50 of FIG 3. DESCRIPTION OF THE PREFERRED EMBODIMENT Shown in FIG. 1 is playing piece 10. The playing piece 10 comprises two outer parts of a shell. A rough textured part is a half 12 of the piece 10. The half 12 may also be made to exhibit as first color, red, for example, whereas another part of the shell may be made to exhibit a second color, white, for example. Another half 14 of the piece 10 is smooth textured and fits snugly against the half 12 to form a spherical body. Each half, 12 and 14, is designed with a concentric flat face 16 thereon. As illustrated in FIG. 2, each playing piece 10 is held together by any suitable means such as a cylindrical member, for example. The cylindrical member in the present embodiment is a magnet 18 having opposite poles 20 and 22. Poles 20 and 22 may be north poles and south poles, respectively. Usually these poles are designated "N-" and "S-", respectively. The piece 10 is generally describable as comprised of two halves 12 and 14 which exhibit mirror symmetry with respect to each other as to their shape. In fact, they are mirror symmetric about an imaginary plane at their juncture. This means that a half 12 placed at the plane P projects the shape of the other half 14 into the plane P provided the plane P is a reflecting mirror. The flat faces 16 of the halves 12 and 14 are further arranged such that they are parallel to the plane P and concentric with an imaginary principal symmetry axis Q of the piece 10. The axis Q is therefore orthogonal to the plane P and flat faces 16. The magnet 18 has a principal longitudinal symmetry axis R. When the piece 10 is manufactured and assembled axis R is coincident with the axis Q. The plane P then bilaterally traverses the magnet 18. The plane P is generally referred to as a mirror-symmetric internal plane of the piece 10. The magnet 18 is mirror-symmetric about the imaginary plane S. When piece 10 is assembled the plane S is coincident with the plane P. The axis R is referred to as an internal principal symmetry axis. The game is played with a plurality of pieces 10, for example ten pieces, assembled according to FIG. 2 to appear as shown in FIG. 1. The plurality is assembled such that one pole of the piece magnet 18, for example an N-pole, is located in the first half 12 in a preselected number of the pieces 10, for example seven pieces, and such that the other poles of the remaining piece magnets 10 are located in the second half 14. A portion of the pieces 10, for example one-half or five, are provided for one player. This portion is placed on a playing board with a first mirror-symmetric half, for example half 12, oriented away from the board. The remaining pieces 10 have their second mirror-symmetric half, for example half 14, located away from the board and are provided for another player. A plurality of persons play the game on a board 30. The board 30 comprises a solid molded upper frame 32, a solid molded lower frame 34, a field plate 36, and a plurality of board magnets 38. The upper frame 32 has an opening 40 which is adapted to receive a protruded part 42 of the lower frame 34. The part 42 is press fitted into the opening 40 and the board 30 is held together by friction between the upper frame 32 and the lower frame 34, the field plate 36 being held therebetween. A first surface 44 of the board 30 is divided into a plurality of spaces, for example squares 46 and squares 48. The squares 46 are distinguished from the squares 48 by a color difference. The squares 46 may be colored white, for example, and the squares 48 may be colored red, for example. The game is played on either of the sets of squares 46 and 48. Thus, the playing squares used for a game are alternate linear squences of playing squares, for example sequences 50 anf 52, which are diagonally oriented with respect to an edge 54 of a surface, which in this example is the surface 44. Another method of distinguishing the squares 46 from the squares 48 is to provide a difference in texture such as a smooth surface for the squares 46 and a rough surface for the squares 48. A carity 60 is located in each of the playing squares 46 and 48, preferably in the center thereof. The cavity 60 is a spherical depression in the upper frame 32 with a flat face 62 located as a surface thereof. Each cavity 60 has an aperture 64 on the surface 46 or 48. A periphery of the flat face 62 is concentric with the periphery of the aperture 64. The cavity 60 has a surface which is comprised of the flat face 62 and a spherical wall 66. The wall 66 is preferably shaped and adaptd to receive either half 12 or 14 of the piece 10. The field plate 36 is comprised of a material which attracts both poles 20 and 22 of magnets 18. It is shaped and adapted to fit only under all of the peripheral squares of the game board. The upper frame 32 has four edges 54, 72, 74 and 76. The field plate 36 lies under the playing squares 46 and 48 adjacent these edges. Similarly, like playing squares on a surface 78 of the lower frame 34 which are adjacent edges 80, 82, 84, and 86 thereof underlie the field plate 36. The lower frame 34 is adapted to receive the plate 36 around the periphery 88 of the protruded part 42, the plate 36 being adapted to lie on a flat surface 90 of the frame 34 and a flat surface 92 of the upper frame 32 being adapted to lie on the plate 36. A cavity 40 in the upper frame 32 is adapted to receive the protruding part 42. The surface 78 of the lower frame 34 is similar to the surfce 44 of the upper frame 32 and has like cavities therein and like squares thereon. The squares 46 and 48 on surface 78 may be similarly colored or textured or differently colored or textured. The protruded part 42 of the lower frame 34 has openings 94 therein which are adapted to receive the magnets 38. The openings 94 have apertures 96 at the surface 98 of the frame 34. Any opening 94 receives all of a magnet 38. Hence, one flat surface 100 of the magnet 38 is flush with an aperture 96 and proximate to an adjacent flat face 62 on the surface 44 of the frame 32. The corresponding opposite flate surface 100 on the magnet 38 is adjacent a similar flat face 62 on the surface 78. The game may be played by first linearly arranging four pieces 10 in like squares 46 adjacent one edge 76, for example, and four pieces in like squares 46 adjacent another edge 72, for example. Alternate moves, of each player's own pieces, by each player are made to a different like square 46 until either a first player's pieces 10 are all in the original location of a second player's pieces 10 or all of the first player's pieces have been flipped so that another half 12 or 14 is showing. Either the first player or the second player may move first to commence the game. The pieces 10 are equipped with an outer housing which is adapted to be spherical and received by the cavities 60 such that they are flipped and repositioned in the cavity 60 when an opposite pole of a magnet adjacent a flat face 62 is encountered by a half 12 or 14 of a piece 10. The pattern of the board 30 may be changed, i.e., the positions of the magnets 38 relative to an edge, such as 54, in front of or associated with a player. This is designed into the board by purposefully not placing magnets 38 adjacent all of the squares 46 and 48. The magnets 38 are placed adjacent some of both the squares 46 and the squares 48 in an asymmetric pattern. The pattern is therefore semi-automatically changed with respect to a player by rotating the board about an axis orthogonal to a surface 44, for example n/2 pi radians where n is not a multiple of 4. This feature of the board is predicated upon the player being stationary with respect to the board. There are two like surfaces 44 and 78 of the board 30. Because the magnets 38 are heteropolar, i.e., have different poles, an "S-" pole and an "N-" pole, for example, when one pole is adjacent a flat face 62 of the frame 32 the other different pole is adjacent the opposite face 62 in the frame 34. Thus, when the board 30 is flipped over such that the surface 78 is used for play a new and different pattern is present. Various combinations of flips and rotations of the board 30 may be selected to achieve a new pattern or program. With the magnets 38 fixed a total of eight different patterns may be used. The board 30 has a novel design which further permits the locations of the magnets 38 with respect to each other to be changed to give a virtually unlimited variety of patterns or programs. The frames 32 and 34 are frictionally held together and are openable and reclosable whereby the magnets 38 are removable, reorientable in their openings 94, rearrangeable, and replaceable. As a further means of changing the pattern or program additional magnets may be added. FIG. 4 provides a cross-sectional view of the assembly of FIG. 3. Shown there is a partial section of the upper frame 32 and a partial section of the lower frame 34 along the line 50--50. The flat faces 62 of the cavities 60 are adjacent faces of the magnet 38. As shown, cavities 62 are on each surface 44 and 78 and concentric with an underlying magnet 38 or cavity 94. The invention is predicated upon a greater frictional resistance to the motion of the piece 10 with respect to the surface 66 of the cavity 60. When the flat 16 is congruent with and adjacent the flat 62 of the cavity 60, The firctional resistance to a movement of the playing piece 10 is greatest. At other positions of the piece 10 with respect to the cavity 60, only one spot on the piece 10 is touching the flat 62 and a coincidence of the surface of the piece 10 with the periphery 64 of the cavity forms a line of contact resembling an arc. The inventor has experimentally determined that when like poles are adjacent the face 16 and the face 62, during contact, movement of the piece 10 by a repelling magnetic force raises the piece 10 and decreases the frictional resistance enabling the piece 10 to flip to a more stable mechanical position wherein another face 16 with an opposite underlying pole positions itself adjacent the face 62. Experiments with a completely spherical piece and a spherical cavity adapted to receive said piece have resulted in inadequate and asymmetric repositioning of the piece.

1a

BACKGROUND 1. Field of Invention This invention relates to wheelchairs and is particularly directed to decorative body shells which are mountable on conventional wheelchairs to simulate automobiles and the like. 2. Prior Art As is well known, many thousands of people are confined to wheelchairs each year, due to illness, accident or other misfortune. When this occurs, a considerable amount of mental therapy is required to assist the victim in adjusting to such confinement. While such adjustment is a serious matter with all wheelchair patients, it is far more serious in the case of children, who often tend to develop severe inferiority complexes as a result of such confinement. Furthermore, wheelchairs are designed for function, rather than for aesthetics, and the appearance of prior art wheelchairs is certainly not pleasing to the eye and even tends to have an appearance which is mentally depressing. Thus, prior art wheelchairs serve to provide mobility for non-ambulatory patients, however, the appearance of the prior art wheelchairs also serves as a constant reminder to the patients that they are disabled. These problems are especially aggravated for children when the wheelchair patients encounter other children playing in peddle-driven toy vehicles, such as cars, trucks, airplanes and the like. Unfortunately, most wheelchair patients cannot operate such peddle-driven vehicles, even if they could manage to climb into and out of such toy vehicles. Thus, the wheelchair patients must simply sit by and watch, while other children enjoy such toys. Over the years, numerous improvements have been made to improve the functioning of wheelchairs and to provide accessories which would enhance the functionality of wheelchair patients. However, virtually nothing has been done to improve the appearance of the wheelchairs. Thus, none of the prior art wheelchairs have been entirely satisfactory. BRIEF SUMMARY AND OBJECTS OF INVENTION These disadvantages of prior art wheelchairs are overcome with the present invention and improved wheelchairs are provided which are pleasing in appearance and which serve to significantly improve the patient's self-image and to greatly decrease the patient's mental depression. These advantages of the present invention are preferably attained by providing body shells which are attachable to the wheelchair frame and which simulate the appearance of an automotive vehicle or the like. Accordingly, it is an object of the present invention to provide a wheelchair which is attractive in appearance. Another object of the present invention is to provide an wheelchair having an appearance which serves to enhance a patient's self-image. An additional object of the present invention is to provide means to enhance the appearance of the wheelchair. A further object of the present invention is to provide means for enabling a wheelchair to simulate the appearance of an automotive vehicle or the like. A specific object of the present invention is to provide means for improving the appearance of a wheelchair comprising body shells which are attachable to the wheelchair frame and which simulate the appearance of automotive vehicles or the like. These and other objects and features of the present invention will be apparent from the following detailed description, taken with reference to the figures of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of a wheelchair embodying the present invention; FIG. 2 is a front view of the wheelchair of FIG. 1; FIG. 3 is a longitudinal section through the wheelchair of FIG. 1; FIG. 4 is a rear view of one of the wheel covers of the body shell of FIG. 1; FIG. 5 is a top view of the wheelchair of FIG. 1; FIG. 6 is a view similar to that of FIG. 5 showing the front and rear portions of the decorative shell opened to facilitate folding of the wheelchair for storage or transportation; FIG. 7 is a front view of an alternative form of the decorative body shell of FIG. 1; and FIG. 8 is a side view of the body shell of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION In that form of the present invention chosen for purposes of illustration in the drawing, FIGS. 1-5 show a wheelchair, indicated generally at 10, enclosed within a decorative body shell 12 which simulates the appearance of an automotive vehicle, in this instance, a fire engine. As best seen in FIGS. 3 and 5, the body shell 12 comprises a pair of side panels 14 and 16 which are secured to the frame 18 of the wheelchair 10 by suitable means, such as machine screws, bolts or the like, not shown. The side panels 14 and 16 may be flat sheet of material, such as wood, plastic, metal, fiberboard or the like. Preferably, however, the side panels 14 and 16 will be contoured to provide a more three-dimensional simulation of the desired appearance. Adjacent the front ends 20 and 22 of the side panels 14 and 16, are hinged front sections 24, 26 and 28. Sections 24 are generally extensions of the side panels, 14 and 16, respectively, which are hingedly connected to the front ends 20 and 22 of the side panels 14 and 16 and which project beyond the footrest 30 of the wheelchair, as best seen in FIG. 3. Sections 26 are lateral components which are hingedly connected to the respective side panels 14 or 16 and which extend inwardly therefrom to simulate the grill and windshield of the vehicle. Sections 28 are horizontal components which are hingedly connected to the side panels 14 or 16 and which overlie the lateral sections 26 to simulate the hood or cab roof of the vehicle. If desired, suitable accessories, such as rotating lights 32, sirens 34 or the like may be mounted on the horizontal sections 28, as shown, and may be operable, if desired, by manual or electrical means, as is well known. Finally, wheel covers 36 may be provided, secured to the wheels 40, but sufficiently inside of the handwheels 38 to prevent interference with the patient's hands, when the patient is using the handwheels 38 to manipulate the wheelchair 10. As seen in FIG. 4, the wheel covers 36 are formed of two half-circular members 42 having central recesses 44 for fitting about the axle 46 of the wheelchair wheel 40. The wheel cover halves 42 are joined by suitable means, such as braces 48 secured to the members 42 by screws 50. side panels 14 and 16 may also carry rear sections 52, which are hingedly secured to the rear ends 54 of the side panels 14 or 16 and extend inwardly to simulate the rear end of the vehicle. Preferably, suitable means, such as magnetic latches 56 will be provided to releasably connect the adjoining edges of the lateral sections 26, horizontal section 28 and rear sections 52 of side panel 14 to the corresponding members of side panel 16 to form a complete body shell, as indicated generally at 58, and, hence, to provide the appearance of an integral vehicle. Obviously, the exterior surfaces of the body shell 58 may be decorated, substantially as desired, to enhance the vehicle simulation. In use, the body shell 58 is mounted to enclose a wheelchair 10 and the side panels 14 and 16 are secured to the frame 18 of the wheelchair 10 by suitable means, such as machine screws, bolts or the like, not shown. In the normal position, the lateral sections 26, horizontal sections 28 and rear sections 54 of side panel 14 will extend toward the corresponding components of side panel 16 and will be releasably secured together by suitable means, such as magnetic latches 56. Consequently, the body shell 58 will substantially enclose the wheelchair 10 to simulate the appearance of a desired vehicle. To allow a patient to enter the wheelchair 10, the horizontal front sections 28 are swung upwardly, outwardly and downwardly, to lie adjacent the outside of the extension front sections 24, as seen in FIG. 6, and the extension front sections 24 are swung open, as indicated by arrows 60. This opens the entire forward area of the wheelchair 10 to allow the patient to enter the wheelchair 10 in a normal manner. When the patient is seated on the seat 62 of the wheelchair 10 and their feet have been placed on the footrest 30, the extension front sections 24 and horizontal front sections 28 are returned to the closed positions, providing the appearance that the patient is seated within the simulated vehicle. The patient may then maneuver the wheelchair in a conventional manner, by appropriate manipulation of the handwheels 38. Also, the patient may actuate the rotating light 32 and siren 34 in accordance with the play action suggested by the appearance of the vehicle simulated by the body shell 58. For storage or transportation, the horizontal front sections 28 are folded over outside of the extension front sections 24 and the lateral front sections 26 are folded inwardly, as indicated by arrows 64 to lie adjacent the inside of the extension sections 24. Also, the rear sections 52 are folded inwardly to lie adjacent the outside of the rear end 54 of the side panels 14 and 16. Thereafter, the wheelchair 10 may be collapsed in a conventional manner for storage or transportation, with the body shell 58 occupying little, if any, additional space. FIGS. 7 and 8 show an alternative form of body shell, indicated generally at 66, simulating the appearance of aircraft. The aircraft body shell 66 is comprised os side panels 68 and 70 which are secured to the frame 18 of the wheelchair 10 by suitable means, such as machine screws, bolts or the like, not shown, to enclose the wheelchair 10 in substantially the same manner as described above with respect to the fire engine body shell 58 of FIGS. 1-3. In this form of the present invention, semi-conical front sections 72 and 74 are hingedly connected to the front ends 76 of the side panels 68 and 70, respectively, to enclose the footrest 30 and front end of the wheelchair 10 and to simulate the nose of an airplane. The adjacent edges of the semi-conical front sections 72 and 74 may be releasably secured together by suitable means, such as magnetic latches 56. To allow the patient to enter the wheelchair 10, the semi-conical front sections 72 and 74 are swung open and apart to allow free access to the wheelchair 10 and seat 62. For storage and transportation, the semi-conical front sections 72 and 74 may be opened, as for allowing entry to the wheelchair, or may be removed and stored separately, due to their additional bulk. Obviously, different body shells may be provided which simulate numerous different types of vehicles, such as automobiles, trucks, military vehicles, boats, etc. substantially as desired. In addition, numerous other variations and modifications can obviously be made without departing from the spirit of the present invention. Therefore, it should be clearly understood that the forms of the present invention described above and shown in the figures of the accompanying drawings are illustrative only and are not intended to limit the scope of the present invention.

1a

SCOPE OF THE INVENTION The present invention relates generally to a golf swing training device and more particularly to a golf swing training device, which may be used to improve the characteristics of a person's golf club swing. BACKGROUND OF THE INVENTION There are a number of factors which come into play in achieving a proper golf club swing, any one of which if improperly executed may result in a poor swing. These factors include such elements as a proper stance and address of the ball by the golfer, a proper grip of the golf club, proper body position during the golf swing, and the proper swing motion. Of the aforementioned factors affecting the golfer's shot it is the proper swing motion which the is most difficult to achieve. It is also the swing motion which may very well be the most important single factor in achieving an optimum golf shot. If the golfer does not swing the golf club properly, the golfer's head may move, his body may be forced into an incorrect position, the golfer may loose the correct weight transfer or the club may be brought out of correct alignment with the ball. A proper swing motion has two principal elements. These elements include, firstly, the physical swing plane, namely the path which the properly swung golf club must follow, and secondly, the tempo of the swing, also known as swing timing or rhythm. The tempo of the golf club swing refers to the velocity with which the golf club head is travelling through a particular phase of the swing. The tempo can, therefore, be defined as the relationship of the club speed at the various points of the swing and the timing of these points to one another, taken from the beginning of the backswing to the end of the follow-through. For a successful golf swing, the club must not only move through a consistent and well defined physical path, but it must also follow this path with a consistent, smooth tempo or rhythm. These crucial factors can be the most elusive to refine, as it is difficult to sense exactly where or when within the swing the problem lies or its extent, since the human eye cannot easily gauge the club head speed at every instant. With the proper tempo, a golf swing becomes one fluid motion rather than a series of disjointed events. In order to achieve this fluid motion, the golfer is forced to master all elements of the swing. With proper swing tempo achieved, each part of the swing places the club and the body in the correct position and relative motion for the next portion of the swing, and so on. This is really the essential, underlying principle when people speak of having perfected or "grooved" their swing. A factor which contributes to the difficulty in developing the proper swing motion is that it varies somewhat with the age, sex, strength, build, temperament and stature of the golfer. In spite of this difficulty, it is widely recognized that once a golfer has mastered all of the basics of the golf swing, including the proper swing plane, the remaining essential element which separates an average or even good golfer from a great golfer is the swing tempo. Previous efforts to perfect a means of teaching the proper swing tempo include the use of slow-motion video replays of the golfer's swing, and the use of remote motion-sensing technology. With the former, the problem is in obtaining precise, useful analysis without delay as by the time the stroke has been analyzed, the golfer has forgotten how it felt. Video replays also make a comparison between separate golf swings difficult. Proper analysis of the video requires the expertise of a professional, raising costs and decreasing availability and usability. With motion-sensing technology, the desired results can be obtained, but there are serious limitations in the application of the technology. To make the system truly reliable and usable requires extremely sophisticated technology which is not only very expensive, but which also requires carefully controlled operating conditions, as well as the installation upon the golf club and in some cases the golfer of a series of infrared light emitting diodes which must be hardwire to the system. This technology is far better suited to a laboratory or clinic than to the golf course or for home practice. In an effort to assist golfers in learning the correct swing motion, training systems have been developed to teach golfers to swing the club in the correct physical swing plane. Known training systems act to guide the end of a golfer's club as it travels in movement. Typically, these training devices provide a means to compel the individual to swing the club along a predetermined arc or plane by using a geometric swing path for the golfer's backswing and follow-through. Prior patents which are pertinent, include Canadian laid open patent application S.N. 2,031,458 to Bellagamba, filed Dec. 9, 1990, and U.S. Pat. No. 4,852,881 to Bellagamba et al, both of which teach a golf swing training apparatus having a PVC arcuate pipe which acts to guide the shaft of the golf club during the user's swing. U.S. Pat. No. 2,520,287, to Plunkett shows a golf club guiding device which captures a golf club and holds it in position for a spiral like swing. Zega U.S. Pat. No. 2,653,025 teaches a mechanical golf instruction aid which captures the golf club and holds it for a predetermined swing. U.S. Pat. No. 2,713,491, to Plunkett et al, teaches a golf club guiding device for guiding the club in a predetermined manner. The MacStocker U.S. Pat. No. 1,960,787 is for a golf club guiding system directing the club around a predetermined swing. U.S. Pat. No. 4,040,633 to Sciarrillo teaches a golf swing training machine supported by a base sitting on an angled surface and guides the golf club on a spiraled pipe guide. The U.S. patent to Wilson U.S. Pat. No. 3,794,329 is for a golf teaching apparatus in which the shaft of a golf club is attached to a sleeve which slides on a track to control the swing of a person practicing on the device. In U.S. Pat. No. 3,744,799 to Hightower a golf practice device has a guiding track for teaching the proper technique for swinging a golf club. A difficulty with these known golf swing training apparatus, is that while they assist in improving the golfers accuracy in swinging the club through the correct physical swing plane, they do not assist in teaching the user the proper club swing tempo. Additionally, known golf swing training apparatus only provide the user with a "fixed" plane of club movement. There is no means of comparing a person's club swing with a preferred club golf swing which has been executed by a professional or expert golfer. On occasion, even an accomplished golfer may experience an "off" swing, in which something has gone wrong with his club swing motion. If the golfer's swing tempo has altered, recovery to the proper swing motion may take an extended period if the golfer has adapted to the new incorrect swing tempo. Known golf training apparatus are disadvantageous as they do not permit a progressive comparison of the swing movement with the golfer's previous golf swings, his average club swing or his best golf club swing. While prior art patents disclose an adjustable swing training apparatus, the individual settings used for each individual golfer require precise, time consuming calibration of the swing training apparatus. This results in inefficient use of the training apparatus and increased cost in man-hours required for set-up. Known golf training apparatus are also more suitable for teaching the proper "full" swing, as one would use with various woods and low angled irons. These known devices are of little use in teaching the proper swing motion for a sand wedge, pitching wedge or other high angle iron shots. SUMMARY OF THE INVENTION It is an object of this invention to overcome the disadvantages of prior art golf swing training devices by providing an inexpensive golf swing training apparatus which guides a person's golf club in the correct physical swing plane during a golf swing, and which further provides the golfer with an analysis of additional golf swing characteristics. In another one of its objects, the present invention provides a golf swing training device which permits substantially, instantaneous comparison of a characteristic of the user's golf club swing to that of a previous or preferred golf club swing. Another object is to provide a golf swing training apparatus which permits rapid, precise calibration of the golf club swing guide for each individual user. Another object is to provide a golf swing training apparatus which assists the user in developing the proper swing motion for use with a number of different golf clubs. Accordingly, the present invention provides a golf swing training apparatus having a frame with a base for sitting on the ground. An arcuate, or other known golf club swing guide is attached to the frame for guiding a person's swing by physically limiting movement of the club such that the golf club contacts the golf swing guide as it travels therealong. A device which senses a particular characteristic of the golf club swing is incorporated within the golf club training apparatus. The sensing device is connected to a microprocessor, or the like, to provide the user with an output of the sensed characteristic. The various characteristics of the golf swing which may be analyzed, include the tempo of the swing, the distance the club traveled on the golfer's backswing or follow-through, angular distance the golf club travels away from the plane of the club swing guide, or other similar features of the club movement. In one preferred embodiment, the sensor device is used to produce a data signal representative of the golfer's swing tempo. The sensor device comprising a number of individual induction type sensors, which are located at spaced locations within the golf club swing guide. Each sensor sequentially provides the processor with sensor readings as the club or club shaft passes thereby. The processor converts the sensor readings into an output representative of the golf swing tempo or club speed as it moves through individual parts of the swing path. The number and configuration of the sensors within the golf swing guide varies depending on the degree of accuracy which is to be achieved, and the overall cost of the golf swing training apparatus. To analyze a particular golfer's swing, the golfer stands in the training apparatus and swings his golf club in a known manner. On each of the swing backstroke, downstroke and follow-through the club slides along the swing guide sequentially activating each of the sensors. Preferably, the microprocessor instantaneously converts the timing between sequential sensor readings which are received from the induction sensors, into a graphically displayed output. Output displayed in this manner provides the golfer with substantially immediate feedback of the tempo of his golf swing. As such, the golfer may immediately repeat his swing correcting any deficiencies in swing motion. If desired, the tempo of the user's swing may also be compared with the tempo of a prerecorded swing stored in the memory of the microprocessor. The prerecorded swing may be the user's previous or best swing, a computer generated average of the user's previous swings, a preferred golf club swing executed by a professional golfer, or any other desired swing. The training apparatus is not restricted to teaching the proper swing motion for woods, and may also be used to establish correct swing motion for all golf clubs including pitching wedges, sand wedges and putters. In a more preferred embodiment, the golf swing training apparatus is adjustable in height and angular position to accommodate a number of individual users. Frame members which are movable by means of an electric motor may be used in the adjustment of the golf swing guide. The electric motor is controlled by the microprocessor so as to move the golf swing training apparatus quickly and precisely to a pre-set position selected for each individual user. In a first aspect, this invention resides in a golf swing training apparatus comprising: a frame, a golf club swing guide attached to said frame, said golf club swing guide for guiding a person's swing, the improvement wherein, said golf club swing guide including sensing means, said sensing means for generating a first set of data signals upon sensing movement of a golf club thereby during said person's swing, said first set of data signals representative of a characteristic of said person's golf club swing, and computing means, said computing means having processing means for processing said first set of data signals for generating an output signal. In another aspect, the invention resides in a method of analyzing a golf swing using a golf swing training apparatus comprising a frame, a golf club swing guide for guiding a person's golf swing, attached to said frame; said golf club swing guide including a plurality of sensors for generating a first set of data signals upon sensing movement of a golf club thereby during said person's swing, said first set of data signals representative of the tempo of said person's swing, and a microprocessor including storage for storing a second set of data signals, said second set of data signals being representative of the tempo of a prerecorded golf club swing, said microprocessor having processing means for processing said sets of data signals for generating output signals, said method comprising the steps of swinging said golf club along said golf club swing guide to generate said first set of data signals, and comparing an output signal generated from said first set of data signals with an output signal generated from said second set of data signals. BRIEF DESCRIPTION OF THE DRAWINGS Other objects, features and advantages of the present invention will become apparent from the following detailed description and drawings in which: FIG. 1 is a perspective view of a known golf training apparatus; FIG. 2 is a perspective view of a golf training apparatus in accordance with a first embodiment of the invention and having a golfer positioned therein; FIG. 3 is a perspective view of golf training apparatus in accordance with a second embodiment of the present invention having a golfer positioned therein; FIG. 4 is a perspective view of a golf training apparatus in accordance with a third embodiment of the invention; FIG. 5 is an enlarged, partial perspective view of the vertical support shown in FIG. 4; and FIG. 6 is a sample output display in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Reference is made first to FIG. 2, which shows a golf swing training apparatus generally indicated 10. The swing training apparatus 10 is best shown in FIG. 2 as comprising three principle elements, a frame 12, a golf club swing guide 14, and a sensor device 16 which comprises a number of individual sensors 18. In a first embodiment, the frame 12 and golf swing guide 14 are of a known construction as shown in FIG. 1. The frame 12 includes a base portion 20 for sitting on the ground. Frame 12, in addition to base 20, includes vertically extendable telescoping members 22a, 22b, 22c and 22d extending from the base 20, a pair of telescoping angled frame members 24 and horizontal frame members 26 and 27 connected between the vertical members 22a and 22b. As seen best in FIG. 1, telescoping angled frame members 24 brace vertically extending telescoping members 22a and 22b in a generally upright position. Each end of the upper horizontal member 26 is coupled to an elbow 28 having a T-joint 30 attached thereto. Each T-joint 30 has an angled support member 32 slidingly received therethrough. The forward most end of each angled support member 32 has attached clasping members 34, for supporting the upper portion of the swing guide 14. The clasping members 34 resemble a T-joint having a portion removed so as to receive in a snap fit manner a portion of the swing guide 14 which is formed as an arcuate pipe 15. The configuration of the clasping members 34 is such that in attachment clasping members 34 are spaced from the forward most surface of the guide 14 to enable the smooth slide of a golf club therealong. Independent sliding of members 32 through an associated T-joint 30 permits adjustment of the tilt of the upper portion of the swing guide 14 relative to its lower portion to adjust the angular orientation of the swing guide 14. A pair of forwardly extending telescoping base frame members 36 are held by T-joints between a bracing member 38 and horizontal frame member 40. Each end of the horizontal frame member 40 rotatably supports telescoping vertical members 22c and 22d, which in turn support clasping members 42 similar in configuration to the clasping members 34. Additional bracing members 44 are provided in the frame 12 to provide the training apparatus 10 with added stability. The golf club swing guide 14 comprises a circular pipe 15 which is preferably made from light weight plastics such as polyvinvylchloride (PVC) which is formed into an arcuate shape approximately 6 feet in diameter. As seen best in FIG. 2, a number of individual normally-open induction type sensors 18 are located at spaced locations within the pipe 15. Each induction sensor 18 is configured to emit a sensor reading upon sensing the golf club 46 as it passes immediately adjacent thereto. The spacing of the sensors 18 along the swing guide 14 is selected to provide an accurate indication of the location of the golf club 46 during a particular phase of the golfer's swing. The sensors 18 are spaced closer together near the apex and nadir of the swing guide 14 to permit more accurate detection of swing tempo during the golfer's address of the ball and backswing where the club speed typically slows. The sensors 18 are embedded within the pipe 15 so as not to interfere with the movement of the golf club 46 as it slides along the swing guide 14 during the golfer's swing. The swing guide 14 is designed in such a way that the swing guide 14 may be removed and a similar but smaller diameter swing guide (not shown) may be optionally substituted or added to accommodate smaller golfers, with its sensors taking the place of the sensors 18 in the standard sized swing guide 14. This changeover would be facilitated by the use of a single multiple pin wiring connector that would permit the entire set of sensors to be disconnected and re-connected in one step. A central processing unit (CPU) 50, which includes memory and video display terminal 52, is provided in electrical connection with each of the sensors 18, by means of wiring 54. Where possible, wiring 54 is housed within the tube 15 and frame 12 so not to interfere with the golfer's swing. The CPU 50 contains the electronic circuitry which collects and processes the sensor readings to produce a graphic display on the monitor 52, representing the speed of the club 46 over each position of the swing. The CPU 50 further includes memory to store data such as the physical spacing of the individual sensors 18 relative to each other and the sensor readings produced by the user's golf swing, and/or the golf swing of others. The circuitry of the CPU 50 preferably permits the manipulation of the sensor readings, permitting an averaging of a number of the user's golf swings, or the simultaneous graphic output representing sensor readings from two or more different golf swings. The frame 12 is designed to support the swing guide 14 in such a way that the swing guide 14 can be adjusted through a range of height and angle positions to fit the requirements of substantially all golfers of various height and stature. As is to be appreciated, when the telescoping slide members 32 are pulled rearwards through the T-joints 30, the upper portion of the swing guide 14 can be tilted backward. Similarly, the entire swing guide 14 can be shifted forward or backwards by telescoping base frame member 36 while moving slide members 32. The guide tube 15 is assisted in its tilt by the partial rotation of telescoping members 22c and 22d. Adjustment of the height and the swing guide 14 may additionally be achieved by selectively extending or shortening the length of each vertical member 28a, 22b, 22c and 22d. The golf swing training apparatus 10 is configured to permit a golfer free access to stand in area 48 within the frame 12. So positioned, the user may swing the golf club 46 so that the shaft of the club 46 substantially remains in sliding contact with the tube 15 throughout the entire swing, to ensure the correct physical swing plane. In operation, the golfer stands in the correct golf position in area 48. The swing training apparatus 10 is then positioned at the appropriate height and angular position having regard to the golfer's size and stature, so that when the club 46 moves along the swing guide 14 it travels in the optimum physical swing plane. With the training apparatus 10 in the correct position, the golfer next addresses the ball (shown in FIG. 4 as 96). A lower most sensor 18a is used to detect the presence of the golf club 46 as the golfer prepares to commence the golf swing. Once the sensor 18 detects the continual presence of the club 46 for an extended period of time, as contrasted with the period of detection during a golf swing, the CPU 50 sets the training apparatus 10 to a START mode. Preferably, the training apparatus 10 is set to a start mode on sensor 18a, detecting the presence of club 46 for a period of three seconds. As seen best in FIG. 3, a visual indicator panel 56 is optimally used to provide an indicator signal to the golfer that recordal of the golf swing tempo will commence once the golfer begins his swing. Alternatively, it is also possible to provide a manual start to the recordal of the swing by means of a foot pedal microswitch or the like (not shown), however, the use of a visual indicator 56 and CPU control is advantageous as it enables the golfer to control the operation of the training apparatus 10 by the movement of the club 46, allowing repeated golf swings without breaking the user's concentration. If the golfer shifts position before taking his swing and in the process moves the club 46 away from the sensor 18a, the CPU 50 will recognize this as a false start, because the loss-of-signal from sensor 18a was not immediately followed by a sensor reading from an adjacent sensor 18. The indicator panel 56 will provide a FALSE START signal and the CPU 50 will re-set the training apparatus 10 once the club 46 has been repositioned at sensor 18a. Upon the start of a swing, the loss-of-signal at sensor 18a is immediately followed by a brief sensor reading from an adjacent sensor 18. The CPU 50 processes the sensor reading sequence and automatically determines whether the swing is right or left-handed. As the golfer swings club 46, beginning with the backswing and followed by the downswing and follow-through, the club 46 is detected by each sensor 18 it passes. As each sensor 18 is triggered "on" by the passing club 46, the individual sensor 18 transmits to the CPU 50 a sensor reading. The precise time interval between sensor readings from adjacent sensors 18 may be computed together with the spacing distances between the sensors 18 which are stored in the CPU 50 memory. Central Processing Unit 50 software analyzes the time for the club 46 to travel the distance between adjacent sensors to determine the tempo of the golf swing. Two additional data manipulations are made by the Central Processing Unit 50. First, the exact transition point at which the backswing ends and the downswing begins is determined. In terms of sensor readings, there are only two sequences of readings possible. In one case, the club rises in the backswing just high enough to activate a sensor 18, but no further before the downswing. For example if sensor 18c is activated by a full swing, the sequence "18b, 18c and 18b" is produced. In the second case, the club 46 rises just beyond sensor 18c before reversing direction, triggering sensor 18c twice in a row producing the sequence "18b, 18c, 18c and 18b". In the former, the Central Processing Unit 50 would take the precise time reading for sensor 18c as the time of the transition from backswing to downswing. In the latter case, the Central Processing Unit 50 will take a time half-way between the two successive sensor 18c readings (the segment time) to be the point of transition. For graphing purposes, as in reality, the Central Processing Unit 50 assumes that the instantaneous speed at the point of transition must be "zero". Of course, in the case of a left-handed swing, or a shorter swing used with a different club, the specific sensors activated would be appropriately altered, but the same principles apply. The CPU 50 is also used to determine the end point of the swing follow-through. As the club 46 slows to a stop, it triggers a sensor 18 for an extended period. The Central Processing Unit 50 will assume that the swing has ended when the elapsed time after the latest sensor reading is greater than double the time interval between the last two sensor readings. At this point, the swing will be assumed to have ended at the last usable sensor reading. As the club 46 was still in motion during this last time interval, the ending average speed will not be set to "zero" on the graph, however, this does not cause any difficulty in use. Since each sensor 18 can only yield an on/off reading and not speed or direction, the pattern of readings must be analyzed in order to calculate speed and direction. Direction is, of course, fairly simple, since it is obviously the order in which the sensor readings were collected. As indicated by calculating the time interval between adjacent sensor readings and dividing this figure into the known distance between sensors 18 and adjusting for club 46 to tube 15 displacement, the speed for each segment can be calculated. However, this speed is the average speed for the segment, and to graph this, the most accurate assumption is that the average speed was achieved at the middle or centre of the segment or the corresponding time interval. Once the golf swing is completed, the sensor readings are stored in the memory of the CPU 50 for future reference, permitting the golfer to chart the change or improvement in his swing tempo. Some, or all, of these sensor readings may also be averaged by the CPU 50 to produce a "typical" golf swing for a given golfer. By programming the memory of the Central Processing Unit 50 with the tempo of a prerecorded golf club swing, the CPU 50 may be used to generate a comparison between the tempo of the user's swing and the tempo of the prerecorded swing almost instantly after the golfer has completed his swing. Golf swings, which are preferably prerecorded include the user's previous golf swings, or an average thereof, or a golf swing executed by a professional golfer having similar size and stature. The video display terminal 52 of the Central Processing Unit 50 is used to provide a graphic output 58 of the tempo of the user's golf swing, shown best in FIG. 6. A typical output display, graphically charts the speed of the user's club 46 through the swing. If desired, multiple graphs may be simultaneously output to enable a comparison of the graphic representation of the user's swing 58 with a representation of any number of faster or slower preferred swings 60. Where a comparison between golf swings is desired, the CPU 50 may also activate a display on the indicator panel 56 to indicate the results of an overall comparison between the golfer's just-completed swing and the comparison swing, using a previously user-selected degree-of-accuracy which can be expressed as a percent (e.g. within 5%, 10%, 15%, etc.) or by the golfer's handicap. For example, if the degree-of-accuracy is set at 10%, and the golfer's overall swing stayed within +/-10% of the comparison swing, the indicator panel 56 would indicate a positive display. Alternatively, if the speed of the golfer's swing between any two sensors exceeded by 10%, or was slower than the tempo of the control swing by more than 10%, the indicator panel 56 would indicate a negative display. FIG. 6 shows three graphs superimposed. The graph of the golfer's swing is shown as 58, while the graphs of the comparison swings are shown as 60. As is to be appreciated, the graphic display is advantageous as it instantly highlights the exact nature and extent of any error or deviation in the golfer's swing tempo. In subsequent swings, the golfer will have instant feedback on his progress in correcting his swing in a way that no human instructor can. The ability to compare a swing with a variety of other swings assists in overcoming the problem of each golfer having a slightly different personal ideal tempo. Once a golfer has perfected his swing, he can save that in the computer's memory for future comparison if his swing later changes. FIG. 3 shows best a second embodiment of the present invention. Each of the golf swing training apparatus 70a and 70b shown have similar construction to the golf swing training apparatus 10 shown in FIG. 2 with like numerals used to designate like components. Each golf swing training apparatus 70a and 70b comprises a frame 20 which is configured to adjustably support a swing guide 14 in various height and angular positions by the selective telescoping vertical extension of members 22a, 22b, 22c and 22d. The upper end of each vertical frame member 22a and 22b is coupled directly to a T-joint 30. Angled support members 32 slidingly received through each T-joint 30 support swing guide 14 by clasping members 34. Vertical members 22c and 22d include an angled uppermost end secured directly to clasping members 42. As is to be appreciated, the frame 12 of the training apparatus 70 may be constructed of a heavier gauge PVC pipe so as to provide a stable support for the swing guide 14, without the need for numerous bracing members. The swing guide 14 is similar to that shown in FIG. 2. Sensors 18 are located within the swing guide for generating sensor readings as the golfer's club 46 passes thereby in the manner previously described. In contrast to the apparatus shown in FIG. 2, sensors 18 of each of the swing training apparatus 70a and 70b are provided in electrical connection with a single Central Processing Unit 100, by means of electrical cables 54a and 54b. The Central Processing Unit 100 (CPU) includes memory and video display terminal 102. CPU 100 contains electronic circuitry which collects and processes the sensor readings produced by sensors 18 in each of training apparatus 70a and 70b. A remote control panel 104 is provided in each of apparatus 70a and apparatus 70b. Control panel 104 allows the user to individually select the desired output configuration and parameters from within the training apparatus 70 to minimize the user's loss of concentration. Providing a single Central Processing Unit 100 for use with multiple golf swing training apparatus 70 advantageously results in a more economical and efficient use of resources. While FIG. 3 illustrates two training apparatus 70a and 70b connected to a CPU 100, additional training apparatus may further be added. Reference is now made to FIG. 4, which shows a golf swing training apparatus 110 in accordance with a third embodiment. The golf swing training apparatus 110 comprises a golf club swing guide 14, and sensor device 16 of a similar configuration to that shown in FIG. 2. The swing guide 14 is rigidly secured within an enclosure forming frame 112. Frame 112 includes a tabular base portion 114 for resting on the ground. In addition to the base 114, the frame 112 includes two generally vertical support members 116 projecting upwardly therefrom. As best seen in FIG. 5, each vertical support member 116 comprises a frame 117, clasping member 118 and electric motor 120. Each frame 117 includes a central, generally rectangular aperture 122. Electric motor 120 is mounted within the aperture 122 and is vertically movable therein by means of a traction drive mechanism 124. The clasping member 118 is movably secured at one end to a rotatable shaft 126 of the electric motor 120. Clasping members 118 resemble clasping members 34, shown in FIG. 1, and permit securement of the swing guide 14 to the frame 112 without interfering with the movement of golf club 46 as it travels along the swing guide 14. As is to be appreciated, by actuating the motor 120 to move vertically within aperture 122, and/or to rotate the clasping member 118 by the rotation of shaft 126, the swing guide 14 may be moved to a number of different height and angular positions in accordance with the size and stature of the golfer using the training apparatus 110. The motor 120 may be secured in a desired position so as to secure the swing guide 14. While shown movable by means of traction drive 124, it is to be appreciated that movement of motor 120 may be achieved by hydraulic or other drive mechanisms. In other respects, the training apparatus 110 incorporates similar features as those disclosed in respect of the golf swing training apparatus shown in FIGS. 2 and 3, wherein similar reference numerals are used to designate similar elements. The training apparatus includes Central Processor 50, and video display terminal 52. As seen in FIG. 4, the video display terminal 52 is mounted in sidewall 88b, allowing substantially instantaneously viewing of the graphic output. Control panel 53 is provided within the training apparatus 110 to allow the user selection and modification of the desired output. The Central Processing Unit 50 is programmed with desired height and angle position of the swing guide 14 of each user. The CPU 50 actuates the electric motor 120 in response to an ID code input on control panel 53, which is unique to a particular golfer. On receiving the ID code, the Central Processing Unit 50 actuates the movement of the motor 120, and thereby the swing guide 14, to the programmed height and angle position. Positioning of the guide 14 by the CPU 50 eliminates the need to take extra time to recalibrate the correct swing guide position for each new user. In the apparatus shown in FIG. 4, the frame 112 in addition to side wall 88b, includes side walls 88a and covering panel 90, thereby permitting use of the apparatus 110 in adverse weather conditions. Lighting elements 92 may optimally be provided to permit night use of the training apparatus 110. The use of the apparatus 110 shown in FIG. 4 is substantially the same as the use of the apparatus shown in FIG. 2. The golfer stands in the correct golf position on golf mat 94, and addresses the ball 96 located on tee 98. The visual indicator 56, located forward of the golfer and adjacent to tee 98, provides the golfer with a signal that the recordal of the golf swing tempo has commenced. Recordal and output of the golf swing tempo is achieved in substantially the same manner described with respect to the first embodiment. While it is preferred that the output from the Central Processing Unit be in the form of a graphic representation on a video display terminal, it is appreciated that the invention is not so limited. Many other modes of and devices for output are possible. As is to be appreciated from the drawings, and disclosure, the number and placement of individual sensors may vary. In general, the greater the number of individual sensors the greater the accuracy with which the swing tempo may be determined. While the sensors disclosed are normally open induction-type sensors, the invention is not so limited. Other suitable sensing means including, but not limited to photo and sonic operated sensors may equally be used, and will now become apparent. While each of the three golf swing training apparatus show a particular frame structure for supporting the swing guide, it is to be appreciated that other frame structures, including single pedestal supports incorporating power adjustments for swing guide height and tilt, may be equally be substituted. Further, other swing guides which are irregularly shaped, discontinuous, or which are configured for telescoping adjustment, may equally be used with the present invention. While the invention has been described with reference to preferred embodiments, it is not so limited. Many modifications and variations will now occur to persons skilled in the art. For a definition of the invention, reference is made to the appended claims.

1a

BACKGROUND OF THE INVENTION [0001] 1. Technical Field [0002] This invention is directed toward a hockey puck. The invention is more particularly directed toward a practice hockey puck to be used to practice picking up the puck on the blade of a hockey stick. [0003] 2. Background Art [0004] Young boys playing hockey like to emulate the professional hockey players. They see the players picking up the puck on the blade of their stick, to hand it to the referee for example, and try to do the same but the pick-up is difficult to learn. [0005] To normally pick up the puck, a player places the front of the blade of his stick flat on the top of the puck on the ice. He then applies pressure to one side of the puck with the edge of the blade on that side to tip the puck up on its side. From its on-side position, with the blade now positioned flat against a flat side of the puck, the blade is moved against the puck while rotating the blade up to a horizontal position. This movement lands the puck flat on top of the blade. It is difficult for a young player to get a feel for the amount of pressure to be applied, and where and how the pressure should be applied, on the puck with the stick to tilt the puck onto its side. SUMMARY OF THE INVENTION [0006] The practice puck of the present invention is designed to make it easier for the player to get a feel for the correct pressure point and the amount of pressure needed to tilt the puck onto its side. The puck is designed to have an overhang past the pivot edge of the puck making it much easier to tilt the puck about the pivot edge onto its side. The overhang is achieved providing the puck with a cylindrical top portion and a bottom portion that lies within the perimeter of the top portion. The bottom portion can be cylindrical and concentric within the top portion. The bottom outer edge of the lower portion forms a bottom pivot edge and the bottom outer edge of the top portion forms a top pivot edge. It will be seen that the outer part of the top portion overhangs the bottom portion. Pressing down on the outer part of the top portion of the puck with the blade of a stick readily tilts it about the bottom pivot edge on the lower portion of the puck. The puck tilts till it abuts on the top pivot edge formed by the top portion of the puck. Continued pressure on the outer part of the top portion with the blade will further tilt the puck on its top pivot edge until the puck is on its side. Once a young player has practiced with the practice puck to build a feel for the amount of, and the location of, the pressure to be applied, he can more easily and quickly learn to pick up a regular puck. [0007] The invention is particularly directed toward a practice hockey puck having a cylindrical top portion and a bottom portion. The top portion has a top, circular surface and a top, cylindrical, side surface extending down from the outer perimeter of the top surface. The top portion is between three-eighths and five-eighths the thickness of the puck. The bottom portion has a bottom surface parallel to the top surface with the outer perimeter of the bottom surface spaced inwardly of the outer perimeter of the top surface. The bottom portion also has a bottom, side surface joining the outer perimeter of the bottom surface with the bottom edge of the top cylindrical side surface. The connection between the bottom, side surface and the top, cylindrical, side surface forms a top pivot edge for the puck while the connection between the bottom, side surface and the bottom surface forms a bottom pivot edge for the puck located below and inwardly of the top pivot edge. DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS [0008] FIG. 1 is a schematic view showing where pressure is applied to a regular puck to tip it onto its side; [0009] FIG. 2 is a schematic view showing the puck moving onto its side; [0010] FIG. 3 is a schematic view showing the on-side puck being rotated by the blade; [0011] FIG. 4 shows the puck flat on the blade of the stick; [0012] FIG. 5 shows a practice puck; [0013] FIG. 6 is a schematic view showing where pressure is initially applied to the practice puck; [0014] FIG. 7 shows the puck at a further pressure applying stage; [0015] FIG. 8 shows the practice puck on its side; [0016] FIG. 9 shows a modification of the practice puck; [0017] FIG. 10 shows the puck of FIG. 9 tilted; [0018] FIG. 11 shows another modification of the practice puck; [0019] FIG. 12 shows a bottom view of the puck shown in FIG. 11 ; [0020] FIG. 13 shows a bottom view of another modified practice puck; and [0021] FIG. 14 shows a bottom view of yet another modified practice puck. DETAILED DESCRIPTION OF THE INVENTION [0022] In the prior art, an ordinary hockey puck 1 , as shown in FIGS. 1 to 4 , is a cylindrical disk three inches in diameter and one inch thick having a top circular surface 3 and a parallel bottom circular surface 5 . A cylindrical side surface 7 joins the top and bottom surfaces 3 , 5 . To pick up the puck lying on the ice ‘I’ with his hockey stick, a player first places the front of the blade 9 of his stick flat on the top surface 3 of the of the puck. Through the handle of the stick, the player then applies pressure, as shown by the arrow ‘A’, through one side 11 of the blade 9 to the top of the puck adjacent its top edge 13 as shown in FIG. 1 . The pressure is applied mainly downwardly but also slightly outwardly in a manner tending to rotate the puck about its bottom edge 15 , as shown in FIG. 2 , to sit on its side surface 7 with the blade 9 now vertical and still adjacent the top surface 3 of the puck as shown in FIG. 3 . The blade 9 of the stick is then used to sweep the upstanding puck up while rotating the blade to a horizontal position. The puck is swept up as shown by the arrow B in FIG. 3 . with pressure applied against the bottom of the puck by the edge 11 . The blade 9 carries the puck to a horizontal position resting flat on the blade 9 , the blade now upside down from its initial position. The sequence shown through FIGS. 1-4 occurs in one fluid motion. [0023] The manner of applying pressure with the blade of the stick to a puck lying on the ice to rotate it upright is difficult to learn. To help a young player learn, a practice puck is provided having a construction making it easier to rotate the puck from a flat position on the ice onto its side using a hockey stick blade. The practice puck is provided with a first bottom pivot edge located inwardly of the side of the puck. The puck has an overhang outwardly of the bottom pivot edge. The overhang makes it easier to initially tilt the puck about the bottom pivot edge with the blade of the stick applying pressure to the top surface of the puck adjacent its side. This pressure is applied outwardly of the bottom pivot edge making it easy to tilt the puck. The puck is first tilted about the bottom pivot edge until a top pivot edge, provide by the overhang and located above and outwardly of the bottom pivot edge, touches the ice. The application of pressure is continued with the blade to now continue tilting the puck about the top pivot edge until the puck is upright on its side. The pressure applied is still outwardly of the top pivot edge making it easy to continue tilting the puck to an upright position. [0024] In more detail, the practice hockey puck 101 of the present invention, as shown in FIG. 5 is in the shape of a modified cylindrical disk and has a top portion 103 and a bottom portion 105 . The top portion 103 has a thickness ranging from about three-eighths to five-eighths the thickness of the puck. Preferably, the top portion is about half the thickness of the puck. The top portion 103 is cylindrical in shape and has a circular top surface 107 and a circular bottom 109 . A cylindrical top side surface 111 joins the top surface 107 and the bottom 109 . The bottom portion 105 has the shape of an inverted, right-truncated, cone and has a circular bottom surface 113 , parallel to the top surface 107 , a larger circular top 115 , and an angled bottom side surface 117 joining the bottom surface 113 and the top 115 of the bottom portion 105 . The top 115 of the bottom portion 105 is the same size as the bottom 109 of the top portion 103 and is integral with it. The bottom surface 113 obviously has a smaller perimeter than the perimeter of the top surface 107 and is centrally located with respect to the top surface. The bottom side surface 117 extends at an angle to the bottom surface 113 at around forty five degrees but the angle can range between thirty and sixty degrees, the lower range normally being used when the top portion is around five-eighths the thickness of the puck and the upper range normally being used when the top portion is around three-eighths the thickness of the puck. [0025] The joint between the bottom surface 113 of the bottom portion 105 and the angled bottom side surface 117 forms a bottom pivot edge 121 . The joint between the angled bottom side surface 117 and the cylindrical top side surface 111 of the top portion forms a top pivot edge 123 . The angled side surface 117 forms an undercut 125 in the lower outer portion of the puck leaving an overhanging portion 127 over the undercut 125 formed by a upper, outer portion of the puck. The bottom pivot edge 121 is spaced inwardly, and downwardly, of the top pivot edge 123 . [0026] In using the practice puck 101 , with the puck flat on the ice ‘I’ on the bottom surface 113 of its bottom portion 105 , the player places the blade 131 of his hockey stick flat on the top surface 107 of the puck, as shown in FIG. 6 and with an edge 133 of the blade 131 presses down on the puck adjacent its side surface 111 as shown by the arrow ‘C’. The pressure is applied by the edge 133 of the blade on the overhanging portion 127 of the puck which lies outside of the bottom pivot edge 121 causing the puck to easily tilt about the bottom pivot edge 121 onto the angled surface 117 as shown in FIG. 7 . In this position the puck is already half upright. Continued pressure by the edge 133 of the blade 131 on the puck adjacent its side surface 111 causes the puck to easily continue pivoting upright about the top pivot edge 123 until it rests on its side surface 111 as shown in FIG. 8 . The downward pressure applied by the edge 133 of the hockey stick, as shown by the arrow ‘D’, is at or just outside the top pivot edge 123 making the puck pivot easily upright. [0027] Once on its side surface 111 , the player can then sweep the puck sideways and up with the blade of the stick as shown by the arrow ‘E’, in FIG. 8 , to complete the pick-up in the same manner the regular puck is picked up as shown in FIGS. 3 and 4 . After a player practices with the practice puck 101 he gets a feel for the manner in which, and where, the pressure must be applied to tilt the puck upright and he can transfer this feel to tilting a regular pick upright. [0028] The practice puck can have different shapes to provide the undercut and overhanging portion. As shown in FIGS. 9 and 10 , the practice puck 201 can have a modified cylindrical shape with a cylindrical top portion 203 and a smaller cylindrical bottom portion 205 . Again, the top portion 203 has a thickness ranging between three-eighths and five-eighths the thickness of the puck but preferably around one half the thickness of the puck. The bottom portion 205 is concentric within the top portion 203 . The top portion 203 has a top circular surface 207 and a bottom, annular surface 209 joined by a top, cylindrical side surface 211 . The bottom portion 205 has a circular top 213 and a bottom circular surface 215 joined by a bottom side surface 216 . The bottom side surface 216 comprises a cylindrical, side surface portion 217 joining the top 213 and bottom surface 215 and the annular bottom surface 209 of the top portion 203 . The top 213 of the bottom portion 205 is integral with the top portion 203 . [0029] The practice puck 201 has an undercut 219 about its lower, outer portion and an overhang 221 about its upper portion over the undercut 219 . The joint between the cylindrical side surface portion 217 of the bottom side surface 216 , and the bottom surface 213 in the bottom portion 205 forms a bottom pivot edge 223 while the joint between the top side surface 211 and the annular surface 209 of the top portion 203 , forming part of the bottom side surface 216 , forms a top pivot edge 225 . As with the puck 101 , a blade 231 of a hockey stick is laid flat on the top 203 of the puck and pressure is applied along one edge 233 of the blade as shown by the arrow ‘F’ to tilt the puck first about the bottom pivot edge 223 until the top pivot edge 225 hits the ice I, and then about the top pivot edge 225 , as shown in FIG. 10 , until the puck rests on its top side surface 211 . The pressure is applied on the overhang 221 outside of the bottom and top pivot edges 223 , 225 to make it easy to move the puck to an upright position. [0030] The bottom cylindrical portion 205 of the practice puck 201 could be replaced with a bottom cylindrical ring portion, as shown in FIGS. 11 and 12 , to provide a practice puck 301 . The puck 301 has a top cylindrical portion 303 and a bottom ring portion 305 . The ring portion 305 is smaller in diameter than the top cylindrical portion 303 but concentric within it. The top cylindrical portion 303 has a top circular surface 309 , a bottom circular surface 311 and a top, cylindrical side surface 313 joining the top and bottom surfaces 309 , 311 . The ring portion 305 has a top ring surface 325 and a bottom ring surface 327 . The top ring surface 325 is integral with the bottom surface 311 of the cylindrical top portion 303 . A bottom side surface 328 comprising a bottom, outer, cylindrical surface portion 329 joining top and bottom ring surfaces 325 , 327 , and an annular outer portion 330 of bottom surface 311 , connects the outer edge of the bottom ring surface 327 with the bottom edge of the top side surface 313 . A bottom, inner cylindrical surface 331 connects the inner edges of the top and bottom ring surfaces 325 , 327 together. A bottom pivot edge 335 , where the bottom side surface 328 joins the outer edge of the bottom ring surface 327 , is provided about which the puck 301 can be initially pivoted by an edge of the blade. A top pivot edge 337 , spaced above and outwardly of the bottom pivot edge 335 , is provided where the top side surface 313 joins the bottom side surface 328 . The puck 301 has a cylindrical undercut 341 in its lower outer portion with a cylindrical overhang 343 in its upper outer portion overhanging the undercut 341 . [0031] If desired, the ring portion 305 ′ could be discontinuous composed of ring segments 345 as shown in FIG. 13 . A discontinuous ring portion 305 ″ could instead be provided with a ring of small protuberances such as small cylindrical posts 347 as shown in FIG. 14 . The posts 347 project from the bottom surface 311 ′ of the top cylindrical portion 303 ′. The outer peripheral portion 349 of the posts 347 form a bottom, discontinuous, cylindrical side surface portion 329 ″. The bottom of the side surface portion 329 ″ forms the bottom pivot edge 335 ″ on the ring portion 305 ″. [0032] It will be obvious that other shapes or forms could be provided for the bottom portion of the puck. The bottom portion could, for example, be octagonal or hexagonal in shape. The only criteria for the bottom portion is that it must be smaller than the top portion, generally centered with respect to the top portion and provide a bottom pivot edge located within the outer diameter of the cylindrical top portion of the puck. The bottom side surface ( 117 , 216 ) joining the bottom surface of the bottom portion of the puck to the top cylindrical side surface of the top portion of the puck can have other shapes as well. The bottom side surface could have a curved cross-section for example, curving gradually up and out from the outer edge of the bottom surface of the bottom portion to the bottom edge of the top, cylindrical, side surface. It could also angle up and out from the outer edge of the bottom surface to the bottom surface of the top portion, and then continue outwardly to the bottom edge of the top, side surface. [0033] If desired, the top surface of the top portion of the puck could be roughened to make it easier for the edge of the blade to grip the top surface to apply pressure to the puck to tilt it with less chance of slipping.

1a

BACKGROUND OF THE INVENTION The present invention relates to a cap for use with a cannula and, more particularly, to a cap having a valve for resealably providing access to the interior of a cannula. A prior art cannula is shown in FIG. 1 and includes a flexible body 10 having a flexible end 12 for insertion into a blood vessel. Prior to insertion of the cannula into the blood vessel, a needle 14 must be inserted through the cannula such that the pointed end of the needle extends beyond the flexible end 12. The needle allows the cannula to be guided through a patient's skin and to penetrate the blood vessel as the cannula 10 is inserted therein. Subsequent to the insertion of the flexible end 12 into a blood vessel, the needle 14 is extracted in order to allow the insertion of a tube for allowing passage of blood or other fluids to r from the cannula 10 through the tube. In order to provide a proper seal around the needle and the tube inserted into the cannula and to prevent blood from flowing out of the cannula when the needle is extracted, a cap member 16 is provided positioned on the end of the cannula 10 and includes a plurality of slits extending radially across the center of the cap 16 for providing a recloseable opening for insertion of the needle and tube therethrough. A recurring problem with the above-described arrangement is the prevention of small leaks through the slits in the cap member after the needle 14 has been withdrawn. One prior art solution for properly sealing a cannula is shown in U.S. Pat. No. 4,655,752 issued to Honkanen et al in which a pair of seal members are provided for closing off the end of a cannula. In particular, a first seal member is provided having a conical shape and a cruciform slit for permitting passage of a surgical instrument therethrough. It is disclosed that fluid pressure will force the cruciform slit portion to contract together to form an impervious seal to fluid flow. However, such a construction depends on the seal members defining the slit being in proper alignment with each other in order to prevent fluid flow and therefore requires that the end portions of the seal be formed as a sufficiently stiff structure to prevent collapse of the seal members in toward each other. In order to prevent fluid flow past the first seal member when a tube is inserted therethrough, a second seal member lacking slits is required to sealingly contact the tube. Thus, two seals are required to effectively prevent flow through the valve portion of the cannula. Accordingly, there is a need for a cap member having a valve portion which will reliably reseal the cannula end after removal of an instrument or tube therefrom. In addition, there is a need for a cap member which will provide an effective seal around the exterior of an instrument or tube which has been inserted into fluid communication with the interior of a cannula. SUMMARY OF THE INVENTION The present invention provides a cap for resealably sealing the end of a cannula to allow the insertion and removal of a tube or surgical instrument such as a needle into the cannula. The cap includes a sleeve defining cylindrical inner and outer surfaces for the cap and a first flange extending radially inwardly from the inner surface of the sleeve at a first end of the cap. A valve body is formed integrally with a radially inner edge of the first flange and extends from the first cap end toward a second end of the cap in spaced relationship to the inner wall of the sleeve. The valve body defines an elongated tube-like member and includes an inlet end adjacent to the first cap end and an outlet end located intermediate the first and second cap ends. The valve body is formed by four radially extending lip or gusset members which are spaced circumferentially from each other and define a right angled cross at an outlet end of the valve body located distal from the inlet end. Each of the lip members includes a pair of web members converging toward each other from the inlet end to the outlet end wherein the web members of each of the lip members meet along a radial line at the outlet end to form a resealable opening for allowing passage of a tube or medical instrument through the outlet end. The web members of adjacent lips intersect each other along web intersection lines and each of the intersection lines extend radially inwardly in a direction from the inlet to the outlet end of the valve body. cap further includes a second flange located at the second cap end and extending radially inwardly a lesser amount than the first flange. The second flange is configured to engage over a radially outwardly extending flange located on an end of a cannula. Thus, when the cap is placed over the end of a cannula the second flange and sleeve surround and form a seal with an exterior surface of the cannula and the valve body will extend into the interior of the cannula where the lip members form a normally closed opening preventing fluid flow out of the cannula through the cap. By providing converging webs forming the lip members, any pressure exerted by fluids in the cannula upon the lip members causes the web members to be compressed inwardly toward each other, thus firmly closing the valve to prevent fluid flow out of the cannula. Other objects and advantages of the invention will be apparent from the following description, the accompanying drawings, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevational view in partial cross-section of a prior art cap member in place on a cannula; FIG. 2 is a partially cut away perspective view of the cap member of the present invention; FIG. 3 is a cross-sectional view of the cap member of the present invention taken along line 3--3 in FIG. 2; FIG. 4 is an end view taken from an outlet end of the cap; FIG. 5 is an end view taken from an inlet end of the cap; and FIG. 6 is a cross-sectional view taken along a line of intersection between adjacent web members and showing the cap in place on the end of a cannula. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 2, the cap 20 of the present invention generally includes a sleeve member 22 defining a first end 24 and second end 26 of the cap 20. A first flange 28 is formed integrally with and extends radially inwardly from the sleeve 22 at the first end 24 of the cap 20, and a second flange 30 is formed integrally with the sleeve 22 and extends radially inwardly from the sleeve 22 at the second end 26 of the cap 20. A valve body 32 is formed integrally with the first flange 28 and extends from the first end 24 toward the second end 26 of the sleeve member 22. As may be seen in FIG. 3, the valve body 32 includes an inlet end 34 located adjacent to the first sleeve end 24 and defined by a radially inner annular surface 33 of the flange 28, and an outlet end 36 located intermediate the first and second ends 24, 26 of the sleeve member 22. The valve body 32 is formed as a tube-like member defining a fluid passage through the cap 20. As may be seen in FIGS. 2, 4 and 5, the valve body 32 includes lip members 38 which extend radially from the center of the valve body 32 and which are circumferentially spaced from each other. The lip members 38 are each defined by a pair of web members 40 wherein the web members 40 of each of the lip members 38 converge from the inlet end 34 toward the outlet end 36 to meet and form a normally closed slit opening 42 at the outlet end 36 of the valve body 32. As is best shown in FIG. 2, the ends of the web members 40 define a substantially planar right angled cross-shaped surface at the outlet end of the valve body 32 and the slits 42 extend through the planar surface at the outlet end 36 and are configured to also form a right-angled cross at the outlet end 36. As may be seen in FIGS. 4 and 5, the web members 40 of adjacent lip members 38 intersect to form intersection lines 44 between the lip members 38. Each of the intersection lines 44 extends radially inwardly in a direction from the inlet end 34 toward the outlet end 36 (see FIG. 3). In addition, each of the lip members 38 is provided with an outer wall 46 connecting its respective pair of web members 40 and defining an outer circumferential extent of the valve body 32, and at the intersection of the valve body 32 with the first flange 28 defines a circular intersection line 48. It should be apparent that the configuration of the lip members 38 is such that the lip members 38 essentially form a configuration resembling a pair of intersecting duck bill valves such that increasing fluid pressure against the exterior of the web members 40 will cause the slit openings 42 to be firmly closed. When a needle or tube is inserted through the inlet end 34 it will contact the edges of the web members 40 defining the slit openings 42 to cause the outlet end 36 of the valve to open and allow passage of the needle or tube. It should be noted that the web members 40 are capable of providing a wide circumference opening whereby a tube having a circumference equal to the circumference of the surface 33 may be inserted without stretching, tearing or otherwise damaging the lip members 38. In other words, the web members 40 form flexible gusset portions creased along the intersection lines 44 which may move radially outwardly in response to passage of a tube through the valve, and subsequently return to their original closed positions upon removal of the tube. The cap member is preferably formed from an elastomeric material such as medical grade silicon and, as may be seen in FIG. 2, the sleeve 22 is formed with substantially cylindrical inner and outer walls 50, 52, respectively for facilitating engagement and sealing with the end of a cannula. In addition, the second flange 30 extends a lesser radial extent inwardly than the first flange 28 and includes an inner cylindrical surface 54 which is also designed to engage and form a seal with an outer wall of a cannula. Referring to FIG. 6, the cap 20 of the present invention is shown in position on an end portion of a cannula 56. The cannula 56 includes a radially extending flange portion 58. The cap is positioned such that the inner wall of the sleeve 22 engages and forms a seal with an outer surface of the flange 58 and the inner surface 54 of the second flange 30 engages and forms a seal with an outer wall portion 60 of the cannula 56. As a result of the intersection line 48 being spaced from the inner sleeve wall 50, the end of the cannula 56 may extend into engagement with an inner surface 62 of the first flange to complete the seal between the cannula 56 and the cap 20. With the cap 20 thus in position, the valve body 32 will extend into the cannula 56 with the lip members 38 in spaced relation to the cannula 56. The cannula 56 is preferably provided with an annular groove or indentation 64 adjacent to the lip members 38 such that a tube having a diameter substantialy equal to the interior diameter of the cannula 56 may be inserted and sufficient room will be provided for outward movement of the lip members 38 as the web members 40 move into the indentation 64. It should also be noted that the circumference of the inner annular surface 33 is such that it will engage and form a seal with a tube inserted into the cannula 56. Thus, the cap 20 of the present invention provides two integrally formed seal portions wherein the web members 40 form an easily opened portion creating a seal when a tube is not passing through the valve, and opening to a large circumference in response to the passage of a tube through the valve. In addition, the inner surface 33 of the flange 28 forms a second seal about a tube inserted through the valve to prevent passage of fluids out of the cannula 56 when the lips 38 have been moved to an open position by the tube. In addition, as a result of using converging web members 40 configured to resemble intersecting duckbill valve members, any reverse fluid flow in a direction from the outlet end 36 toward the inlet end 34 causes an additional closing biasing force to firmly seal the slit areas 42 and prevent fluid leakage through the cap 20 when a tube is not present in the valve. Further, it should be noted that additional lip members 38 may be provided while remaining within the scope of the invention. For example, five or more radially extending lips may be provided, each of the lips including a slit formed by adjoining web members. While the form of apparatus herein described constitutes a preferred embodiment of the invention, it is to be understood that the invention is not limited to this precise form of apparatus and that changes may be made therein without departing from the scope of the invention which is defined in the appended claims.

1a

FIELD OF THE INVENTION [0001] This invention concerns distribution of powder-like substances and particularly relates to a readily portable apparatus, and its functional process, for distributing between multiple processing stations arranged along a food processing deck, particulate food seasonings such as curry powder, sausage seasoning, lemon pepper and the like, in a substantially dust-free, fluidized-like manner. BACKGROUND OF THE INVENTION [0002] In both the process food and snack food fields seasonings are applied to food products for enhancement of the consumers' taste experience as well as to establish the expected flavor profile typical of the products. Frequently the seasonings are furnished to the food processor in bulk, such as in sacks weighing 35 to 50 lbs (15.8 to 22.7 kg) or more. The seasonings are in fine particle form that can be characterized as a powder and frequently the particle sizes range from about 3 microns to about 3 mm. Although there are instances where the seasoning constituents are quite uniform in particle size, there are many other instances where the constituents are quite heterogeneous ranging from large to small particles and consequently tend to segregate into distinct volumes of the small and the large particles during storage. [0003] Generally in food processing plants there are several operating lines producing products differing in sizes, shapes and flavors. Specific seasonings are associated with each of those products and are applied to the products at seasoning “stations” on the processing line. Each seasoning station includes a container or bin of some sort holding a supply of the designated seasonings from which the seasoning is dispensed. This container must be replenished from time to time during a product production run as the seasonings are dispensed on to the products. The intervals for replenishment vary and a replenishment system may stand idle during such intervals. In prior art replenishment systems it was found that during the idle intervals many of the powder like seasonings would segregate, coalesce or generally pack so tightly that to again effectively distribute them some human basic physical efforts were required such as applying blows on the sidewalls of the seasoning container, stirring using an implement or physically shaking the unit. The results of such efforts were uneven and clumps of seasonings would sometimes inadvertently be deposited on the food products which is quite undesirable. [0004] Seasoning replenishment equipment desirably should be characterized by ease of cleaning so that different seasonings may be applied to differing products using the same equipment with only insignificant seasoning “carry over.” The prior art screw conveyors, drag conveyors and bucket elevators were all difficult to clean and required large radius turns and large equipment footprints. In a food processing plant having a number of processing lines each requiring seasonings it is highly desirable to have the seasoning replenishment equipment readily portable so as to facilitate servicing the individual processing lines with ease and with a minimum of disruption or obstruction along the plant's processing deck. [0005] Working with powder-like substances such as seasonings carries the risk of injecting particulate matter or “dust” into the ambient atmosphere within the food processing plant. This is a highly undesirable condition which, if left unaddressed, will deteriorate the working environment and, indeed, may amount to an industrial offense when contravening governmental regulations concerning dean air in the workplace. The prior art pneumatic conveying systems for seasonings seemed to exacerbate this risk and were vulnerable to air leaks, hence dust leaks, within the pneumatic seasonings conveying system. The amount of dust created in a powder transfer process is exponentially related to the volume and velocity of the air used. Moreover, in pneumatic conveying systems the phase density of the conveyed stream is usually quite low given that the propulsive air is mixed with the seasonings, causing a substantial degree of segregation, and also produces dust at the outlet. By phase density we mean powder flow in pounds (kgs) per hour divided by conveying air used in pounds (kgs) per hour. On the other hand, a high phase density means a higher efficiency and lower energy costs, less segregation, less product/seasoning damage and less dust. Long recognized is that system wear in powder conveying systems increases roughly to the 2.8 power of the conveying velocity. Depending on particle friability, size and shape the damage to seasoning particles increases by roughly the same exponent. By vastly increasing the phase density and lowering the transport velocity, the wear on components and damage to the seasoning powder goes down exponentially. SUMMARY OF THE INVENTION AND OBJECTS [0006] The invention in summary concerns a portable seasoning replenishment apparatus including a canister serving to contain a supply of a seasoning to be dispensed at a seasoning applying station arranged in a food processing line. The canister is portable in a rolling action to facilitate serving a plurality of processing stations. One portion of the body of the canister is equipped with a seasonings reception chamber and having reception port means and a seasonings discharge port means. Another portion of the canister body is equipped with a pneumatic chamber or plenum serving to receive a volume of pressurized air and being equipped with an air permeable member serving to emit air into the seasonings chamber at a rate sufficient to fluidize by ablating a portion of the seasonings therein most adjacent to the permeable member. The apparatus may carry its own pressurized air supply or may be connected with a supply of pressurized air within the processing plant. A flexible conduit is coupled to the seasonings discharge port for delivery of seasonings in a fluidized stream at the seasonings applying station in a substantially dust free manner. [0007] A general object of the invention is to curb and control the dispersion of dust components of food seasonings within the food processing plant during seasoning transport at the needed replenishments. [0008] Another object of the invention is to facilitate the handling of food seasonings of the type that tend to duster and sometimes segregate by transporting the seasonings in an improved and gentle manner in a continuous stream that eliminates the need to manually stir or agitate the seasonings such as when encouraging seasoning flow during the replenishing operation. [0009] Still another object of the invention is to provide for the efficient transport of powder-like substances in an improved manner that utilizes a lowered volume and velocity of the transport air thereby to reduce substantially the velocity of the substances and to minimize the disturbance of the main bulk of the substance. [0010] Yet another object of the invention is to reduce the segregation of multi-constituent powder during transport while reducing substantially the incidence of dust dispersion from the powder being moved. [0011] Still another object of the invention is to provide a seasoning replenishment system for transporting powder-like substances that is non-segregating, non harmful to fragile products, low in energy consumption, reliable, dean and safe to operate. [0012] These and other objects of the invention will become apparent from the descriptions of the preferred embodiments that follows taken in connection with the drawings illustrating the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is a perspective view of the seasoning replenishment system made in accordance with and embodying the principles of the present invention; [0014] FIG. 2 is a view like FIG. 1 and showing the opposite side of the replenishment system; [0015] FIG. 3 is a perspective, three-quarter sectional view taken in the direction of the arrows 3 - 3 of FIG. 1 ; [0016] FIG. 4 is an exploded perspective view showing several major components of the subject system: plenum, air permeable cone and powder chamber displayed in a separated relationship, and [0017] FIG. 5 is a greatly enlarged detailed view of the foraminous fluidizing cone showing the air passing apertures therein. DESCRIPTION OF THE PREFERRED EMBODIMENT [0018] The seasoning replenishment system 10 of the present invention is shown clearly in FIGS. 1-3 and comprises a canister body 11 carried by wheels 12 that enable its portability along a processing deck in a food processing plant. A handle 13 is mounted at an upper portion of the canister body 11 and a flexible, seasoning discharge conduit 14 is arranged in communication with the interior of the canister body in a manner to be more fully described below. A vertically adjustable support peg 16 is mounted on the body in a position spaced from the common axis of the wheels 11 so, acting together, the peg 16 and wheels 12 establish a stable platform for receipt and discharge of powder-like seasonings from the canister 11 . A hermetically sealable product loading hatch or door 17 is arranged in the top of the canister body 11 providing for loading of food seasonings 20 into a powder chamber 15 , as shown in FIG. 3 . [0019] A compressed air supply source 18 may be mounted integrally with the canister body 11 , as shown in FIG. 1 , and may comprise well known components such as an electric motor driven air compressor and an associated compressed air storage tank, pressure regulator valve, gauge and filter (not shown). An air supply conduit 19 , as shown in FIGS. 1 and 3 , serves to supply air at a preselected pressure into an air plenum 21 disposed as shown in FIG. 3 at a lower portion of the canister 11 . Where the processing plant has a readily accessible supply of compressed air, as is frequently the case, the supply conduit 19 may be coupled to such air supply with appropriate couplings and air control valves and pressure gages, all well understood in the field. Desirably air pressure in the unit 10 for ablating and fluidizing purposes (which is to be distinguished from pneumatic conveying where air pressure “blows” the powder through a pipe) can be in the range of about 0.5 psi to about 12 psi. However the vast majority of seasoning powders 20 ablate from the bulk powder towards a fluidize flow below 7 psi and quite well at 3 psi. The operating principle is that when fluidized powder has all the properties of a fluid including hydrostatic head. Fluidized seasoning powder will readily flow up to a height above the container depending only on the difference in head pressure and the density of the powder. The fundamental formula Ap=yh applies where Ap=change in head pressure, y=the specific weight of the “liquid” (powder), and h=the change in elevation. It is this relationship that allows the velocity in the conduit 14 to be very low if desired, say for very fragile seasonings, or quite high. Pneumatic conveying systems cannot obtain such ranges of low flow velocities. [0020] The air plenum 21 is shown in FIG. 4 separately from the assembled arrangement of FIG. 3 and includes a cylindrical sidewall 22 ending at the upper portion with an outwardly extending belt flange 23 . Secured to the sidewall 22 is a bottom plate 24 with a central opening 26 for receipt there through in an air tight manner the seasoning discharge conduit 14 . An air conduit fitting 27 is mounted in the sidewall 22 to receive compressed air from the air conduit 19 . [0021] Referring specifically to FIGS. 3 , 4 and 5 , a right cone 31 of foraminous construction is shown and is equipped with a circumferential flange 32 at its widest upper portion, the flange 32 being constructed to mate in an air tight manner with the belt flange 23 of the plenum 21 . At its lower portion the foraminous cone 31 is equipped with a coupling 33 that enables a connection with the seasoning discharge conduit 14 as indicated in FIGS. 3 and 4 b . It will be understood that seasoning powder 20 loaded into the powder chamber 15 seasoning unit 10 will free fall and be supported by the cone 31 . To prevent the powder 20 from packing down, the cone 31 is equipped with a multiplicity of apertures 34 for receiving there through a flow of air from the air plenum 24 which serves to “liquidify” the powder by ablating the boundary layer of seasoning powder laying on the cone 31 , or in other words cause the layer of powder 20 to react much like a liquid, flow like a liquid including supporting a “hydrostatic head.” This quality enables the powder to flow through the conduit 14 for delivery to the selected seasoning station on the processing plant's operation deck (not shown). [0022] The apertures 34 are formed in the fluidizing cone 31 in a process that virtually eliminates burrs which could impede smooth downward flow of the seasoning powder. One process that was found satisfactory, although others may be available, is that of chemical etching causing a hole through the stainless steel cone 31 . A preferable aperture or diametric hole size is about 0.03 inches (0.76 mm) although holes in the range of about 0.01 inches (0.025 mm) to 0.05 inches (1.27 mm) are effective to help the boundary layer of powder (where the powder seeks to contact the walls of the cone 31 ) to collapse and to keep the powder fluidized for flow through the conduit 14 . [0023] The apertures or holes 34 may be arrayed in horizontal rings along the cone wall in a spaced apart relationship in a range of about 1.5 inches (38.1 mm) to about 3.5 inches (88.9 mm) between adjacent holes in the ring with the spacing gradually increasing with the increase in the diameter of the ring. However the holes 34 in the uppermost rings are preferably about 2 inches (50.8 mm) apart so as to encourage more air flow sufficient to squelch the tendency of the power to clump or adhere to the adjacent metal surfaces. [0024] The powder chamber 15 is provided with downward and outwardly tapering sidewalls as may be seen in FIG. 3 . This feature serves to discourage the seasoning powder 20 from adhering to the sidewalls and will encourage the powder when fluidized or liquefied along the boundary layer to flow from the powder chamber out through the conduit 14 in a quasi liquid or fluidized manner. A circumferential flange 35 on the chamber 15 is configured to match with the flanges 21 and 32 for securing together in an air tight manner the components 15 , 21 and 31 to negate the dispersal of dust into the operating environment of the unit 10 . It will be understood, as illustrated in FIG. 3 , that just the seasoning powder 36 that comes in range of the fluidizing apertures or jets 34 (a boundary layer) in the cone 31 becomes fluidized through ablation and flows downwardly, as indicated by the arrows 37 , while the large bulk of powder in the powder chamber 15 is not fluidized. Furthermore air flowing through the jets or apertures 34 penetrates or migrates through the powder bulk and pressurizes the powder chamber 15 furnishing a pressure head to the fluidized powder for delivery through the discharge conduit 14 . [0025] In operation of the seasoning apparatus 10 it is to first initially charge the powder chamber 15 with a selected food seasoning 20 via the hermetically sealable hatch 17 . A bag or sack of food seasonings may weigh from 35 to 50 lbs. (15.8 to 22.7 kg) and the capacity of the powder chamber 15 is ample to receive such quantity of seasonings or more. Commonly, when a bag of seasoning is poured into the powder chamber the powder mixture is segregated by various segregation mechanisms but when processed through the apparatus 10 the segregated quality is minimized and a substantially uniform seasoning out flow results. The seasonings discharge conduit 14 may terminate in a control or shut-off nozzle (not shown) so that seasoning flow may be stopped, kinking the conduit over a 180 degree bend can have the same effect of halting the initial seasoning flow or the discharge end may be simply elevated above the hydrostatic head. Pressurized air is delivered into the air plenum 21 via the conduit 19 from a suitable air supply 18 or the like thus charging the plenum 21 with air pressure in the desirable range of about 3 psi thus to liquefy or fluidize a quantum of the seasoning powder in the boundary layer along the upper surface of the cone 31 via air migration through the apertures 34 in the cone. An air pressure head is established in the powder chamber 15 above the pile or bulk of seasonings. The fluidized seasoning will thereby flow through the discharge conduit 14 to the delivery point at a food processing station for replenishing the seasonings carried away by the food products being processed. In the processing plant the seasoning replenishment apparatus 10 is parked next to the hopper contained on a seasoning applicator (not shown). By means of an automatic sensing system in the hopper the level of seasoning in the hopper and applicator 10 , the hopper is kept full until the apparatus' 10 capacity is depleted of seasoning. At this point the apparatus 10 may be removed for refilling and then returned and reconnected to the hopper while the seasoning equipment continues operation. The ready portability of the unit 10 enabled by the wheels 12 , handle 13 and stability peg 16 is a large advantage for servicing several processing stations in the processing plant, rather than to have plant personnel lugging sacks of seasonings from station to station for dumping and thus raising clouds of dust in such operation. The seasoning apparatus 10 provides for essentially dust free delivery of food seasonings in the replenishing mode and effects an economy in the use of all of the seasonings with none resulting in objectionable dust in the processing plant during the replenishment operation. [0026] Presently there is a high awareness of food and seasoning allergies. It is essential to thoroughly clean a food processing system of any trace of the previous seasoning before the next batch with a different seasoning is run. The seasoning replenishment apparatus 10 is simple and easy to dean and with its portability can be removed from the processing area and replaced with another apparatus 10 loaded with another variety of seasoning. [0027] Generally food seasoning are highly hydroscopic and are supplied in plastic lined bags. When a run of a particular seasoning is completed and there is seasoning remaining in another type of conveying system this must be discarded because of its attractiveness for moisture in the air. The replenishment apparatus 10 as described herein acts as an air tight, sanitary storage container for the seasoning powder remaining at the end of the last processing run. The savings here can be considerable. [0028] While we have shown and described above what is considered to be a preferred embodiment of our invention in a portable, compact, food seasoning replenishment system and the process related thereto, we do not limit ourselves to the exact details of the construction set forth or to the air pressures and aperture sizes and orientation disclosed, and our invention embraces such changes, modifications and equivalents of the parts and their formation and arrangement as coming within the purview of the terms of the claims which follow below.

1a

PRIOR APPLICATION This is a continuation-in-part application of application Ser. No. 09/089,749 now abandoned, filed Jun. 2, 1998 which is a continuation-in-part of application Ser. No. 08/776,260, filed Jan. 21, 1997 (abandoned). BACKGROUND AND SUMMARY OF THE INVENTION The present invention relates to a foldable carrier such as a stretcher comprising on the one hand a thin first layer of an all-round flexible material of large wear and tear strength, having a substantially elongate basic form and forming a carrier, for instance for enabling the use of the carrier as a stretcher, and on the other hand a considerably thicker second layer of elongate basic form which is permanently joined or integrated with the carrier layer and which consists of a porous or fluffy soft material being intended for forming a stretcher part for enabling a comfortable reclining upon the underlay. According to the stretcher of the present invention, two layers are, preferably, intimately integrated with another being formed of one and the same polymer material, for instance polyethylene, the thin carrier layer having a thickness of about 0.6 to 1 mm and a density of 0.9 to 1.0 kg/dm 3 , while the thick, porous layer has a thickness of about 5 mm and a density which is many times lower, for instance about 0.05 kg/dm 3 . Thus, according to its preferred embodiment, the stretcher has a total thickness of around 6 mm; this making it possible to roll it into a spirally wound roll which can be stored in an easy way, e.g. on or in a rucksack. A substantial advantage is that, when needed, it may be quickly and smoothly used as a stretcher. Of this reason, this product is particularly well suited for being stretcher may advantageously be included into the pack of a soldier and fulfil a double function for serving not only as a heart insulating and a point load equalizing sleeping underlay on the top of a bed of brushwood or similar, but also as a flexible stretcher construction in the case when the soldier or persons in his proximity would be injured. However, a shortcoming of this stretcher is that its limited thickness (6 mm in the preferred embodiment) gives a very mediocre, if not to say a directly bad shock absorbing and load distributing capacity. Thus, if the underlay is laid directly upon a hard, plane surface, e.g., upon a stiff bottom of a bed, the comparatively thin, porous layer does not offer any reposing comfort whatsoever. Another general shortcoming of the prior art technology is the fact that stretchers rarely or never are accessible in a satisfactorily large number at or in the proximity of general establishments of different sorts. For instance, in railway and underground train sets often only one, or possibly a few stretchers (in worst case, none at all) are in readiness, which, what is more, not seldom are stowed away in difficultly accessible spaces, occasionally forgotten by the responsible staff. If an accident with many injuries on humans occurs, then the absence of sufficiently many easily accessible stretchers constitutes a circumstance which makes the required rescue work more difficult and retards it, sometimes to such an extent that the injuries are seriously aggravated and even become fatal. The present invention aims at further developing the underlay unit known from WO87/04614 in such a way that, besides being usable as a stretcher, it also may be used as a comfortable stretcher directly upon a plane, hard surface. Thus, a primary object of the invention is to create an underlay unit which in a state of readiness, in which it is ready to be quickly used as a stretcher, may be used in a general way as a shock absorbing and/or load distributing soft unit, e.g., as an effect or part of an effect. In other words, during a long time in a storage or readiness state the unit shall be usable as a shock absorbing and/or supporting soft part, e.g. in the shape of a support-forming part of the back or a seat-forming part, whereafter it shall be possible to quickly and easily convert it into a stretcher. Different forms of flexible mattresses for rescuing and patient evacuating proposes are previously disclosed in WO-A-91/18576, U.S. Pat. No. 4,124,908, U.S. Pat. No. 4,186,453 and U.S. Pat. No. 4,442,557. However, these mattresses lack the slits in the mattresses which are characteristic for the present invention and which form longitudinal folding lines in order to make possible a folding of the mattresses into a package. Further, in WO-A-86/02814 a mattress-like bed underlay is disclosed which is capable of being folded into a seat-forming package. However, in this case, the folding takes place laterally, the bed underlay lacking any sort of longitudinal slits of the sort that characterizes the invention. Nor is the underlay shown in this document capable of being used as a stretcher. Furthermore, the Norwegian design registration No. 68206 provides the mattress with lateral folding notches. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view showing a stretcher according to the present invention; FIG. 2 is a perspective view showing the same stretcher in a folded state of readiness in which is packed in a covering envelope; FIG. 3 is a schematic cross-section showing the stretcher packed in another envelope; FIG. 4 is a similar end view showing three different sections comprised by the stretcher and each one being separately covered by different parts of a covering envelope; FIG. 5 is an end view showing an alternative embodiment of the stretcher; FIG. 6 is an end view illustrating a further alternative embodiment of the stretcher; FIG. 7 is a perspective view corresponding to FIG. 1, showing an embodiment with an alternative design of a surface of the stretcher; FIG. 8 is a schematic perspective view illustrating the use of the stretcher as a part of an interior; FIG. 9 is a partially cut end view showing a stretcher provided with aeration channels; FIG. 10 a is an end view showing an embodiment with two side panels just being enclosed into a common envelope; FIG. 10 b is an end view showing an embodiment similar to the embodiment in FIG. 10 a but the embodiment has no thick middle section; FIG. 11 is an end view showing a further alternative embodiment of the invention; FIG. 12 is a perspective view showing a further alternative embodiment; FIG. 13 is a perspective exploded view illustrating a further alternative embodiment of the invention; FIG. 14 is a perspective view of the invention in an un-folded position including support members; FIG. 15 is a side view of the support member; FIG. 16 is a perspective view of the invention in a folded position including support members; FIG. 17 is a perspective view of the stretcher of the present invention with handles; and FIG. 18 is a perspective side view of the stretcher of the present invention enclosing a patient. DETAILED DESCRIPTION FIG. 1 shows a stretcher which in its entirety is designated by reference numeral 1 and which comprises on the one hand a thin first layer 2 of an all-round flexible material with large wear and tear strength, and on the other hand a considerably thicker second layer 3 which is permanently joined or integrated with the first layer and consists of a porous or fluffy soft material intended to form a stretcher part that makes it possible to comfortably repose on it. Advantageously, the two layers 2 , 3 may be produced in the way disclosed in WO-A-87/04614, i.e., of one and the same polymer material, for instance polyethylene or polypropylene, the material in the strong, thin and carrier layer 2 having a density many times larger than the density of the porous layer 3 . However, it is also possible to produce the two layers of different materials and then connect them to each other, for instance by some sort of adhesive or by heat welding. In the shown example, each of the two layers as a rectangular basic form, although it is feasible to confer to them a slightly tapering form. However, in both cases the basic form is elongate in so far as the length of the stretcher always is larger than its largest width. According to the invention, layer 3 forming the soft stretcher part of the stretcher is divided by one or several longitudinal slits 4 , 4 ′ into several elongate sections 5 , 6 , 7 which are jointly held together by the thin carrier layer 2 . More precisely, the holding together of the stretcher sections 5 , 6 , 7 is effected in portions 8 , 8 ′ which form longitudinal folding lines permitting a folding of the stretcher into a package in which the two sections 6 , 7 are folded inwardly towards the middle section 5 , with the carrier layer parts 2 ′, 2 ″, 2 ″′ turned towards each other. According to an embodiment of the invention preferred in practice, the stretcher part 3 has a thickness of at least 30, suitably at least 50 mm, whereby the stretcher in question is capable of being used as a conventional stretcher, in particular in its folded configuration, for instance in a hospital bed. According to the example in FIG. 1, the stretcher part, i.e. the thick soft layer 3 , is supposed to have a thickness of 50 mm, at the same time as the length of the stretcher amounts to a size of 2000 mm. Advantageously, middle section 5 then has a width within the range of 600 to 900 mm, while the width of each separate side section 6 , 7 amounts to about half of the width of middle section 5 . Therefore, in the folded state shown in FIG. 3 the stretcher gets the form of about 2000 mm and a width within the range of 600 to 800 mm. Of course, also the length, the width and the thickness may deviate from these absolute values. As may be seen in FIG. 1, straps 9 may be connected to the thin and strong carrier layer 2 , which straps on the one hand may consist of carrying straps, on the other hand of straps for holding together the side portions against the body of a lying person. According to a preferred embodiment of the invention, each individual dividing slit 4 has a height equal to the thickness of stretcher part 3 in order to cut the latter down to carrier layer 2 . In other words, the dividing slits keep side section 6 , 7 completely separate from middle section 5 . Therefore the user may replace the middle section 5 for her own middle section, such as his own mattress, without affecting the foldability of the present invention. The folding is carried out solely along previously mentioned portions 8 , 8 ′ of carrier layer 2 . Although side sections 6 , 7 are equally wide according to the example in FIG. 1, they may also be differently wide. According to a preferred embodiments of the invention, the stretcher being folded along the folding lines in question is packed into an enclosing, flexible envelope. One feasible embodiment of such an envelope 10 is shown in FIG. 2 . In this case, the envelope comprises a large-surface which is placed against the inwardly folded side sections 6 , 7 and against the edge parts 11 extending along both the long and the short sides, which edge parts 11 are kept elastically strained against the upper side of middle section 5 , for instance by a flexible straining bad 12 , for example in the form of a rubber band. Advantageously, envelope 10 consists of a suitable textile material, e.g. terry cloth, furniture fabric or similar. It should be obvious that envelope 10 may be easily and quickly pulled off from the packed stretcher in order to make it possible for the later to function as a stretcher. According to an essential aspect of the present invention, the unit 13 shown in FIG. 2 and comprising both the packed stretcher 1 and the enclosing envelope 10 , may be used as an effect in the most diverse circumstances, e.g., as a support-forming part for the back or as a seat-forming part, for instance in a room or in a vehicle. Thus, in its storage or readiness state, the unit may during long times be used as for instance a furniture forming element, whereafter it may be rapidly converted into a rescuing stretcher. This brings about the essential advantage of keeping a large quantity of stretches easily accessible in different public institutions, such as on trains, public buildings, department stores, etc. In FIG. 3 an alternative envelope 14 is shown which encloses and covers the two opposite large-surfaces of the package and at least the longitudinal side edges, in that the envelope is endless. According to this embodiment, the envelope may also cover the short-ends of the package. Also in this case, the envelope may consist of a textile material, although also other materials are feasible, e.g., shrinking plastic, adhering plastic or similar. It should be observed that envelope 14 , equally to envelope 11 , holds together stretcher sections 5 , 6 , 7 and locks these relative to each other in the folded state. In FIG. 5 an alternative embodiment is shown according to which an envelope 15 comprises three different sectors 15 ′, 15 ″, 15 ″′, each separately enclosing the different stretcher sections 5 , 6 , 7 . Thus, in this case the envelope is placed on the stretcher when the different stretcher sections are folded out or are in a common plane, the envelope enclosing the stretcher sections all-round and being on contact with their surfaces. In FIG. 5 an embodiment is shown according to which carrier layer parts 2 ″, 2 ″′ have a smaller width than side sections 6 , 7 of the stretcher part. In this embodiment, the outer longitudinal side parts of the side sections become more flexible and softer than at the embodiment according to FIG. 1 . FIG. 6 shows an embodiment according to which each individual side section is divided into two part-sections 6 ′, 6 ″ and 7 ′, 7 ″, respectively, by a corresponding dividing slit 4 ″, 4 ″′. In this embodiment, the side sections are capable of being more easily connected to the body of a patient. In FIG. 7 an embodiment is shown according to which the upper surface 16 on the middle section 5 of the stretcher part has been conferred an uneven surface structure, for instance in the form of longitudinal graining, with the object of reducing the risk for bedsores in cases when the stretcher is used for long periods as a stretcher, for instance in a hospital bed. In FIG. 9 is illustrated an embodiment according to which the different layers in the sections of the stretcher have been made with through aeration channels 17 which promote the evacuation of humidity and vapor from the stretcher and which may bring about a current of air upwards towards a reposing body, for instance by bringing air to the boundary zone between the stretcher sections. FIG. 10 a shows an embodiment according to which two identical stretcher are supposed to be laid adjacent to each other, with the lying surfaces of middle sections 5 in contact with each other. According to this embodiment, the side sections are folded inwardly towards the middle sections, thus forming a package of four-fold thickness in comparison with the individual stretcher layer 3 , and then the package is enclosed in an envelope. FIG. 10 b is very similar to the embodiment shown in FIG. 10 a but has no middle sections 5 so that the user may use his/her own middle section such as a mattress. FIG. 11 shows an embodiment according to which the individual side section is divided into two lamella-like parts 19 , 19 ′ by a slit 18 , 18 ′ parallel to the carrier layer 2 , which parts 19 , 19 ′ are held together along longitudinal side edges by a reinforcing layer 20 which protrudes from carrier layer 2 . As can be seen in FIG. 12, the lamella part 19 ′ next to the lying surface of middle section 5 may be shorter than the outer lamella part 19 . In this way, the arms of a lying patient or person may be placed between the two lamella parts and be kept locked after the outer lamella parts having been connected to each other, for instance by straps 9 . Thus, when the stretcher is used as a stretcher not only the body and the legs of the patient may be held steadily fixed and still, but also the patient's arms, this being important for instance in connection with rescuing operations and other difficult circumstances. When hands and arms are pressed directly at the body, the ribs of the person may break which may cause a puncture of the lungs. Therefore, the foam is an important separator. Eventually, in FIG. 13 an embodiment is shown according to which the middle section 5 of the stretcher part is composed of on the one hand a lower partial layer 21 and on the other hand of a plurality of superficial part elements 22 , 22 ′, etc. These separate surface elements 22 , 22 ′ may have different densities in order to satisfy the requirements on the lying surface in the best way, which requirements are different for different parts of the body. In practice, the longitudinal slits that form folding lines at the different embodiments of the invention, along which lines the different sections of the stretcher may be folded inwardly towards each other, may be brought about in the most different ways. One way is cutting or sawing in the porous material, after its production into a homogeneous continuous stretcher part. The porous material may also be cut with a knife or a heated thread. Another way is to, already in connection with the producing of the porous layer, form the layer so that dividing slits of desired depth and form are immediately formed. In this context it is pointed out that the cross-sectional form of the individual slit may advantageously be triangular or otherwise tapering, so that wedge-wisely tapering edge parts are formed in the stretcher sections adjacent to each other. The slits may also be made by a melting or pressing operation. It is evident that the invention is not restricted solely to the embodiments described and shown in the drawings. Thus, within the scope of the invention it is feasible to integrate electrically conducting material into the stretcher, for instance by using electrically conducting polymer fibers, which conductivity is so chosen that heat is produced when current is provided. Other ways include providing the foam with a carbon powder or another electrically conductive material. In other words, the stretcher may be kept warm at a temperature suitable for the purpose by the supply of an electrical current. In practice, the electrically conducting material in question should be located in close proximity to the thin carrier layer, so as to avoid the risk of being compressed or stretched in connection with a possible deformation of the stretcher. In this way it is guaranteed that the material always maintains one and the same electrical resistance, thus producing an even heating temperature. Moreover, the geometrical form of the stretcher can vary most considerably. Thus, instead of a rectangular basic shape of the respective stretcher sections also a slightly tapering or wedge-like form may occur. It should also be pointed out that the soft and porous stretcher layer may be composed of two or more part layers. It may also be mentioned that the strong carrier layer 2 may in practice be designed with handles or handle-forming recesses in order to make possible the use of the unit as a stretcher. It is further possible to provide the carrier layer with longitudinal pockets in which stiffening bars may be inserted if desired. FIG. 14 is an alternative embodiment of the present invention. The foldable carrier 100 has a continuous flexible thin support layer 102 that may be made of any flexible material that provides sufficient support to carry a person or animal. A thicker soft middle layer 104 may be attached to the layer 102 . On each side of the layer 104 , soft side layers 106 , 108 may be attached to the layer 102 . Preferably, the layers 106 , 108 are not attached to the layer 104 so that the carrier 100 may be folded along folding lines 110 , 112 . Elongate support members 114 , 116 may be placed along the folding lines 110 , 112 , respectively. The layers 104 , 106 , 108 are soft to make the carrier comfortable for a patient laying in the carrier 100 . FIG. 15 shows a detailed view of the support member 116 . The support member is L-shaped and has a long vertical section 118 and a shorter horizontal section 120 . The L-shape provides extra stiffness. It should be understood that the support member 116 may have any angled shape and is not limited to L-shapes. As best shown in FIG. 15, the horizontal section 120 may be inserted between the layer 104 and the layer 102 and captured therebetween. The section 118 should be flush or slightly below an upper surface 122 of the layer 104 . As best shown in FIG. 16, the carrier 100 may be folded into a folded position by turning the side layers 106 , 108 towards one another and against the layer 102 below the middle layer 104 . It should be noted that the support members 114 , 116 may be placed between the side layers 106 , 108 and the layer 102 so that they are not lost. FIG. 17 shows a detailed view of an underside of the layer 102 including two rows of handles 103 . It should be understood that the layers 104 , 106 , 108 may be removably attached to the support layer 102 so that the patient may use his or her own mattress instead of the layers. FIG. 18 shows an alternative embodiment of a carrier 130 enclosing a patient 132 . The carrier 130 has a continuous support layer 134 that is attached to a thick mid-section 136 and outer side sections 138 , 140 . Similar to FIG. 15, the carrier 130 may include elongate support members 142 , 144 that are attachable at the folding lines 146 , 148 . Inner side sections 150 , 152 are attached to an upper edge 154 of the mid-section 136 . The sections 150 , 152 may have attachments 156 , 158 , respectively so that the attachment 156 may be attached to attachment 158 , as shown by an arrow A, to permit the arms and hands 160 of the patient to be disposed between the inner and outer side sections. A first handle 162 may be attached to an underside of the layer 102 at the folding lines 146 , 148 to permit the lifting and dragging of the carrier 130 with the patient enclosed inside the inner side sections 150 , 152 and the mid-section 134 . While the present invention has been described in accordance with preferred compositions and embodiments, it is to be understood that certain substitutions and alterations may be made thereto without departing from the spirit and scope of the following claims.

1a

BACKGROUND OF THE INVENTION This invention relates to a new and unique facing for a golf club. A set of golf clubs is comprised of a number of woods and a number of irons. This invention relates to a facing for both woods and irons. Golf is a game played with a small round ball and a set of golf clubs. The golf ball is struck with one of the golf clubs and propelled a distance toward a desired spot. A certain spin is imparted to the golf ball due to the contact of the golf ball with the golf club. If the ball is not struck properly the spin imparted may cause the ball to slice or to hook to one side of the playing surface or the other. The elimination of this slice or hook has been sought, probably, since the invention of the game of golf many years ago. It is old art to create a pattern on the facing of a golf club. These patterns have not, however, eliminated the slice or the hook of the golf ball. This invention relates to a new and unique method of eliminating the slice or the hook of the golf ball by creating a new and unique golf club facing. OBJECTS OF THE INVENTION It is the primary object of this invention to construct a golf club facing having a specific pattern so that the slice or the hook of the golf ball will be eliminated. It is a further object of this invention to create a facing on a golf club so that the golf ball, after having been struck, will travel in the direction intended by the player. It is an additional object of this invention to create a golf club facing which is durable and resistant to cuts, nicks, and scratches due to the deposition of a layer of hard chromium plating. DESCRIPTION OF THE DRAWINGS FIG. 1a is a front view of a golf club head showing a rectangular pattern on the facing. FIG. 1b is a front view of a golf club head showing a diamond shaped pattern on the facing. FIG. 2 is a cross-section through FIG. 1a. FIG. 3a is a front view of a detachable golf club facing having a rectangular pattern. FIG. 3b is a front view of a detachable golf club facing having a diamond pattern. FIG. 4 is a cross-sectional view similar to that of FIG. 2 and disclosing a hard chrome coating. DESCRIPTION OF THE INVENTION Referring now to FIG. 1a, a golf club C having a shaft S and a head H is shown. The facing F is that part of the head H which contacts the golf ball (not shown). The groove or slot G is shown in FIG. 2. This slot G has a depth D and a width W. The slot G is channel-shaped such that the width W is constant over the depth D. In this way the slot G resembles an open-ended box-type structure. The facing F contains a number of slots G machined, embossed, cut or engraved onto its face. In the preferred embodiment, the depth D of the slot G is about 0.020 inches and the width W is about 0.080 inches. The distance L between the successive slots is about 0.080 inches. In FIG. 1a the face F of the head H is machined with two sets of slots G. The first of these sets is comprised of a number of parallel vertical slots 10 engraved, machined embossed or cut into the facing F of the head H. The second of the sets of slots is comprised of a number of horizontal parallel slots 12 engraved, machined, embossed or cut into the facing F of the head H. The intersection of these slots, 10 and 12, creates the appearance on the facing F of a number of rectangles. FIG. 1b likewise shows two sets of parallel slots. The slots in FIG. 1b are not, however, horizontal and vertical in direction as in FIG. 1a. Slots 14 are parallel to each other. The slots 14 are at a diagonal on the face F in which the angle between a vertical line and the diagonal is a positive angle. The slots 16 are likewise parallel to each other and on a diagonal, but the angle with the diagonal is negative rather than positive relative to an x, y coordinate. When viewed from the front of the facing F, the intersections of the sets of slots, 14 and 16, resembles a number of diamonds on the facing F. FIGS. 3a and 3b show a detachable facing F of a golf club. In FIGS. 3a and 3b a number of holes 18 are drilled through the facing F in order to provide a means for fastening the facing F to the club C. FIG. 3a has a set of vertical and horizontal slots, creating a number of rectangles, similar to FIG. 1a. FIG. 3b has a set of diagonal slots, creating a number of diamond shapes as is shown in FIG. 1b. In FIG. 4 the slots G and the facing F have a layer of hard chrome plating P deposited on them. This plating P is used to provide a hard, wear resistant, attractive surface for the facing F. This plating P is generally resistant to scratching, cutting, or nicking. In the preferred embodiment of the invention the plating P would have a thickness of approximately 0.004 inches. This plating P would be deposited on the facing F and the slots G after the slots G have been engraved, machined, embossed or cut into the club head H. OPERATION OF THE INVENTION The series of slots G engraved into the facing F are relatively wide when viewed relative to their depth D. A golf ball is a relatively hard, wound or solid, ball covered with a slightly resilient material. When the club C strikes the golf ball the golf ball flattens to some extent. As the golf ball is flattened the series of slots G mesh with and contact with the resilient covering of the golf ball. The facing F and the slots G have a combined surface area greater than that of the facing F alone. It is this greater surface area which is in gripping contact with the golf ball covering. This greater surface area yields a greater gripping contact with the resilient covering. This greater gripping contact results in better control over the spin imparted to the ball. By controlling the spin of the ball, the tendency to slice can be eliminated. The hard chrome plating acts to preserve and protect the inter-connecting slots and to thereby lengthen the useful life of the golf clubs. While this invention has been described as having a preferred design, it is understood that it is capable of further modification, uses and/or adaptations of the invention following in general the principal of the invention and including such departures from the present disclosure as come within known or customery practice in the art to which the invention pertains, and as may be applied to the central features hereinbefore set forth, and fall within the scope of the invention of the limits of the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of Invention This invention relates to fluid-filled bladder-type mattresses such as waterbed mattresses and air mattresses, and particularly to bladder mattresses adapted to suppress undesired lateral and vertical motion of the mattress and undesired fluid wave motion. Suppression of bed motion is desired in both air and waterbed mattresses. Discomfort, difficulty in movement and nausea may result from excessive bed motion. Undesired motion is not only a concern in the more conventional applications and use of fluid-filled beds, it is particularly a problem in fluid-filled beds used for emergency purposes where motion of a bed supporting an injured person may aggravate injury. 2. Description of the Prior Art Waterbed and air mattresses are known wherein motion is suppressed or minimized. Conventional air mattresses comprise, for example, an array of tubular sections formed by bonding the upper surface member to the lower surface member and wherein the sections are in fluid communication through selected constructions. Such a mattress is particularly susceptible to buckling along the bonding ribs, which is undesirable, particularly of an air mattress in emergency or disaster applications where bed movements and buckling may aggravate injury or render transport of a patient more difficult. The problem of wave motion in waterbed mattresses is well-known. Three techniques are known for wave motion suppression in liquid-filled bladders. The first technique involves use of a fluid other than water which is characterized by a high viscosity and inherent damping characteristics. A second technique involves inclusion of energy absorbing means within the bladder. A third technique involves isolation of the fluid within compartments of the mattress. All of these techniques exhibit particular disadvantages. The high viscosity fluid is generally expensive and not readily available. Further, the fluid may present a hazard if the bladder ruptures. Still further, the fluid may not be readily disposable. A popular energy absorbing technique known to the art involves the use of wave motion absorbing cylinders within the bladder. However, undesired gas bubbles tend to be trapped within the cylinders and to be released into the bed, thereby creating gas pockets. The use of barriers to compartmentalize the fluid is only partially effective. Wave motion can readily propagate through most pliant barriers known to the art. Moreover, relatively rigid barriers detract from the known desirable characteristics of liquid fluid-filled mattress, for example, by creating non-uniformities in the support properties of the mattress. Still further, fully compartmentalized structures require individual filling of each compartment. Therefore, except for bifurcated structures (double twin mattresses) provided with absorbent barriers, compartmentalized structures have not been well received. What is therefore needed is a mattress structure which is capable of suppressing waves as well as any motion in the mattress structure without detracting from the support characteristics of the mattress. SUMMARY OF THE INVENTION According to the invention, a fluid-filled bladder-type mattress includes a plurality of pliant panels periodically disposed at oblique angles between upper and lower surface members of the bladder mattress for suppressing motion. In the preferred embodiment of a liquid fluid-filled bladder, a single bladder chamber includes a plurality of planar membrane panel members bonded along angular lines alternately and obliquely to the upper and the lower surface members of the bladder to define a herringbone-type surface bonding pattern. The pattern of panel arrangement has been found to contribute significantly to suppression of liquid fluid wave propagation by dispersing, canceling and dissipating the periodic wave energy. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood by reference to the following detailed description of preferred embodiments in conjunction with the drawings wherein: FIG. 1 is a top plan view of a first embodiment of the invention; FIG. 2 is a side cross sectional view of FIG. 1 along section line 2--2; and FIG. 3 is a top plan view of a rib construction according to the invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIG. 1, there is shown a bladder-type mattress 10 adapted for containing a fluid medium such as water or air. In the particular preferred embodiment disclosed in FIG. 1, the mattress 10 is best suited to contain water for reasons hereinafter explained. Referring to FIG. 1 and FIG. 2 together, the mattress is seen to comprise an upper surface member 12 and a lower surface member 14. Typically the surface members 12, 14 are made of a pliant vinyl sheet material such as polyvinylchloride (PVC) substantially impervious to fluid leakage. The upper surface member 12 and lower surface 14 may be sealingly joined at a side margin 15 to define a fluid tight bladder. According to the invention there is provided within the bladder mattress 10 a plurality of panels 16 disposed interior to the mattress 10 at oblique angles between the upper surface member 12 and the lower surface member 14. The purpose of the panels 16 is to suppress the motion of the mattress 10. The panels 16 preferably comprise a pliant sheet material, such as PVC and are attached to the upper surface member 12 and to the lower surface member 14. When the bladder mattress 10 is inflated, the panels 16 are tightly drawn between the upper surface member and the lower surface member. Preferably, the panels 16 are bonded to the respective upper surface member 12 and lower surface member 14 along linear ribs 18 formed by the fusion of the sheet material of the panels 16 with the upper surface member and lower surface member 12, 14. The panels 16 are preferably formed of a single elongate sheet, and the ribs 18 are preferably disposed in a column array 20 such that the panels 16 define a periodic alternating zigzag pattern of panels 16 between the upper surface member 12 and the lower surface member 14. According to the invention, therefore the ribs 18 and the panels 16 of the mattress 10 adapted to hold water or other liquid are disposed in an oblique angle pattern. Specifically, the ribs 18 are disposed in at least a first column array 20 and second column array 22, the second column array 22 being parallel to the first column array 20, and the ribs of each of the column array 20, 22 being parallel within the column array and oblique to the axes of the respective column array 20, 22. In the top plan view (FIG. 1) the ribs 18 define a herringbone or tractor tire pattern. Viewed in side cross section (FIG. 2) the panels 16 present an oblique face. This disposition is adapted to alternately deflect liquid wave energy transversely incident to the axes of the column array 20, 22 upwardly or downwardly and laterally. Several column arrays 20, 22 and also 24 and 26 are preferred in the liquid-filled mattress 10. Wide width mattresses, such as double, queen and king sizes typically have four to six columns. Generally, at least two different angular dispositions of ribs 18 are preferred. It has been observed that at least two rows of ribs 18 disposed in columns with the sense of the ribs 18 of one column arranged substantially perpendicular to the sense of the ribs in another column produce optimal results. For example, liquid waves incident on one column of panels 16 are not only reflected and dispersed, they appear to be canceled and dissipated, and the resultant waves appear to be channeled to the second column where the panels 16 (disposed with the sense of the ribs 18 arranged to be substantially perpendicular to incident waves) further reflect, disperse, dissipate and cancel the wave energy of the liquid. It has thus been observed that waves are rapidly suppressed and a substantially stable liquid support bed is obtained in a mattress constructed according to the invention. A specific preferred embodiment of a queen-size mattress 10 comprises an upper surface member 12, lower surface member 14, four column arrays 20, 22, 24 and 26 disposed in parallel the length of the mattress and defining panels 16 zigzagging between the upper surface member 12 and lower surface member 14 with linear bonding ribs 18 disposed at approximately 45 degrees to the axes of the column arrays 20, 22, 24 and 26 and perpendicular to the ribs 18 of the adjacent column arrays. The column arrays 20, 22, 24 and 26 may be laterally separated from the lateral sides of the mattress 10 and from one another by approximately the width of the column array. Each of the column arrays is on the order of 8 to 18 inches wide and preferably about 12 inches wide. The ribs 18 of one column array are also disposed to be linearly offset from the ribs 18 of the adjacent column arrays, as is illustrated in FIG. 1. Each of the ribs 18 preferably has rounded or blunt end 28 at the extrema of the bond with the surface members 12, 14, as shown in FIG. 3. The ribs 18 are approximately 3/4 inch wide by about 8 to about 18 inches long. The panels therefore include loose side margins or flaps 30, as shown in FIG. 5, extending about 1/2 to about 2 inches beyond the extrema of the ribs 18. These flaps 30 serve to disperse the tension load at the bond end as between the ribs 18 and the panels 16 to reduce the possibility of rip damage to the mattress material. The invention has now been described with reference to specific preferred embodiments. Other embodiments will be apparent to those with ordinary skill in the art. For example, individual panels 16 may be bonded at oblique angles between the upper surface member 12 and the lower surface member 14 in random or other suitable patterns. In the embodiments herein disclosed, column arrays 20 are preferred because of the ease of bonding an elongate sheet of vinyl material between the upper and lower surface members. Alternatively, the panels 16 may be rigid members attached to only one side, for example, the upper surface member 12, or the panels 16 may be suspended on a support member such as a cord stretched between the lateral sides of the mattress 10. It should be noted that pliant panels are generally preferred because rigid members can introduce nonuniformities into the surface characteristics of the mattress 10. Moreover, a pliant member can extend between the upper surface member and the lower surface member and be attached thereto to provide tension support resisting relative lateral motion of the upper surface member 12 and lower surface member 14, particularly in the case of the air mattress 100 embodiment of FIGS. 3 and 4. Therefore, it is not intended that the invention be limited, except as indicated by the claims appended hereto.

1a

The present application is a division of U.S. Ser. No. 08/567,087, filed Dec. 4, 1995, now U.S. Pat. No. 5,704,280. TECHNICAL FIELD The present invention relates generally to the field of food processing equipment. More particularly, the present invention relates to a device for processing food products, such as cheeses. The device comprises a horizontal conveyor belt over which is mounted a plurality of generally vertical agitators, thus permitting uniform mixing of the food with minimum physical damage to the food. Salt is dispensed in proportion to the amount of food being processed, evenly distributed by staggered stationary salt nozzles over the food being processed, and mixed into the food by the agitators. BACKGROUND OF THE INVENTION The present invention is suitable for producing a variety of cheeses (designated herein as "stirred curd" cheeses), including American style cheeses, such as current manufacture, cheddar, Colby, American, and other washed curd varieties; Italian style cheeses, such as mozzarella, pizza cheese, Parmesan, Romano, and provolone cheeses; semi-soft cheeses, such as brick, Edam, Gouda, Muenster, Monterey Jack, and pepper jack; and Swiss varieties, such as traditional Swiss, baby Swiss, and Jarlsberg cheeses. It is suitable for salting any type of food product, including these and other types of cheeses. Cheesemakers have strong financial incentives to ensure that these cheeses are made up of uniform sized curds and have moisture levels that fall within specific ranges prescribed by government and industry bodies. In the United States, the United States Department of Agriculture (U.S.D.A.) prescribes the ranges for each type of cheese. The cheese moisture level is greatly affected by salt content and distribution. For about the last twenty-five years, stirred curd cheeses have been produced in large, open, tub-like curd tables. Curd tables have vertical agitators mounted on an assembly above the table. As the assembly moves back and forth above the table, the cheese curds are mixed. The vertical agitators ensure that the curds, when mixed, are of uniform size. Thomson, U.S. Pat. No. 3,490,751, issued Jan. 20, 1970; Naulin, U.S. Pat. No. 1,499,026, issued Jun. 24, 1924; and McKinnon, U.S. Pat. No. 794,421, issued Jul. 11, 1905, disclose assemblies that stir cheese curds. Curd tables have serious disadvantages, however. First, making stirred curd cheeses on a curd table is a labor-intensive process. The cheesemaker must start with an empty table, and then fill it with curds and whey. As the curds are mixed and processed, salt must be added to the curds by hand at the proper point in the processing. After mixing and processing the curds, the agitator attachments are removed and replaced with attachments that scoop the product from the table. Because the assembly can remove the product from the curd table only in small scoops, and cannot remove it all at once, the process of removing the curds is time consuming and labor-intensive. To make matters worse, because the assembly is not able to remove curds from the corners and edges of the curd table, after the assembly has been used to remove most of the curds the cheesemaker manually must remove the product that remains in the corners and edges of the curd table. Further, because some curds must sit for longer periods of time than others during the removal process, it is difficult to ensure that moisture levels are uniform in all of the curds. Specifically, because moisture is lost as the curds sit, the curds that are removed earlier will have a higher moisture content than those that are removed later. In addition, the sequential nature of cheese curd processing on a curd table makes it difficult to obtain uniform salt concentrations and consistent levels of acid development. Bacteria are added to obtain the proper acid levels in the cheese; the acid develops at a rate that is a function of the amount of bacteria added and the time the bacteria are allowed to work. When the acid level is within the desired range, users of the curd table must spread salt over the curds manually. Because the salt is distributed by hand, uniform salt dispersion is inherently difficult; and because it takes several minutes to distribute salt over the curds, curds that are salted first are salted at an earlier stage of acid development than are those that are salted later. In addition, because it takes the cheesemaker several minutes to apply salt to the curds, the salt is not applied at a single point in the process. The result of these difficulties is that the acid development and moisture content of the curds are not uniform. Finally, this salting process also is labor-intensive, and inconsistent salt concentrations result because the quantity of cheese delivered from the vat to the curd table may vary from batch to batch. Curd tables have other disadvantages, as well. Because the tables are open, the curds are exposed to airborne contaminants, the rate at which process heat is lost cannot be controlled, and moisture is lost into the atmosphere. Furthermore, the agitator assemblies are complex and require significant maintenance. In addition, curd tables drain the whey from the curds by means of a mesh screen at the bottom of the table. As the curds are mixed, however, they are pushed across the screen repeatedly, which effects a grating action on the curds. This grating action causes small particles, called curd fines, to be lost from the curds and pass through the screen, thus reducing yields. When compared to curd tables, conveyor belt systems save labor. The belt systems that currently are in use were developed approximately fifteen years ago. They use horizontal agitators, which have sharp prongs that physically alter the curds by knitting them together and then grinding them up. Latimer et al., U.S. Pat. No. 4,538,510, issued Sep. 3, 1985, and Brockwell, U.S. Pat. No. 4,309,941, issued Jan. 12, 1982, disclose conveyor belt systems with horizontal agitators. Although systems with horizontal agitators are suitable for some types of cheeses, they are not suitable for processing stirred curd cheeses because they physically damage the cheese curds and cannot produce uniform sized cheese curds. Horizontal agitator systems also have several inherent processing disadvantages. When the curds and whey are dispensed onto the conveyor belt, the mixture is of varying depths or thicknesses. Horizontal agitators are not able to level the mixture across the width of the belt, so mixing is not uniform. Furthermore, because the horizontal agitators tend to grind the cheese, they produce curd fines, thus reducing yields and causing profits to be lost. Also, because horizontal conveyor systems produce curds of different sizes, moisture content and salt penetration varies from curd to curd. There also are disadvantages to the oscillating boom salting apparatuses currently used with conveyor belt systems. First, oscillating booms consist of many moving parts, and thus are expensive to manufacture and to maintain. More important for cheese processing purposes is that the booms apply more salt to the food at each end of the oscillation cycle, and thus do not apply salt to the curds in a uniform manner. These salting problems are exacerbated by the use of the horizontal agitators with conveyor belts. Because the horizontal agitators cannot level the height of the curds across the width of the belt, the salt concentration varies based on the height of the curd mass where the salt is applied. Furthermore, horizontal agitators are unable to mix the salt uniformly across the width of the belt, and instead tend only to push the salt in the same straight-line direction in which the food already is travelling on the conveyor belt. In addition, horizontal agitators spin in a single location, so they are not effective for stirring the food. Horizontal agitator systems also have sanitation problems. The bearings used with horizontal agitators are subject to large loads, and when the bearings wear out and begin to leak. Conversely, cleaning materials may leak into and damage the bearings. Significant maintenance is required to detect and correct leakage problems as soon as they occur. Neither the curd tables nor the conveyor belt systems provides a mechanism for monitoring the moisture level of the cheese curds. The moisture levels therefore cannot be measured until the next day. Because the moisture levels in fully processed cheese cannot be adjusted, if the moisture levels fall outside prescribed parameters, the entire previous day's production of cheese must be disposed of at less than fair market value for that type of cheese. There is an unmet need for a food processing device that allows processing of large quantities of stirred curd cheeses while maintaining the physical consistency and integrity of the curds, and at the same time solves the timing problems associated with curd tables and reduces the amount of labor required to process the cheese curds. It further would be desirable if the food processing device had a mechanized salting apparatus that did not have moving parts, but that did spread the salt evenly over the food being processed and in proportion to the amount of food being processed. SUMMARY OF THE INVENTION The present invention is directed to a food processing device. The invention comprises an elongated housing. In the preferred embodiment, the housing is enclosed. A curd and whey inlet is positioned at the first end (the upstream end) of the housing, and an inlet deflector plate is positioned next to the curd and whey inlet. The distance between the curd and whey inlet and the inlet deflector plate may be adjusted so as to be proportioned to the rate at which the curds and whey flow through the curd and whey inlet. A mixture of curds and whey from the manufacturing vats enters the invention through the curd and whey inlet, and is deflected by the inlet deflector plate and deposited onto a draining screen. In the preferred embodiment, the draining screen is a wedge wire draining screen. A suitable wedge wire draining screen may be purchased from Johnson Filtration Systems of St. Paul. In the preferred embodiment, the angle of the draining screen is adjustable with respect to the curd and whey inlet. As the mixture slides down the draining screen and onto the conveyor belt, a substantial portion of whey is drained from the curds and is collected. A presalt tube apparatus is positioned near the entrance of the device to apply an initial salting to the curds. This initial salting, also called a "presalt," is applied while the temperature of the curds is high to encourage the formation of films, which help keep the curds from knitting together. Additional salt tube apparatuses are mounted toward the second end (the downstream end) of the housing to salt the curds more extensively. The conveyor belt allows whey to drain from the curds without producing cheese fines. In the preferred embodiment, the belt is made of interconnected segments between which liquid may flow. Such a belt may be purchased from Intralox, Inc. of Harahan, Louisiana, or any other suitable supplier. Inclined surfaces are positioned under the conveyor belt to drain whey toward collecting receptacles. The inclined surfaces are positioned independently so that whey drained from nonsalted and presalted curds is collected separately from whey drained from the curds after they have received their more extensive salting later in the processing. Agitators are positioned above the conveyor belt, along the length of the belt, to agitate the curds. In the preferred embodiment, each agitator has an axis of rotation that is generally perpendicular to the upper surface of the material being processed. Because the curds cool as they move down the belt, they are less likely to knit together toward the downstream end of the device. They thus need more agitation toward the upstream end of the device, and less agitation toward the downstream end of the device. Accordingly, in the preferred embodiment, the agitators are spaced farther apart toward the device's downstream end than toward its upstream end, thus permitting the use of fewer agitators and agitator drive means along the length of the device. However, the agitators may be positioned in any manner suitable to the application. For example, it may be desirable to position the agitators so that they agitate an area that overlaps the area agitated by adjacent upstream or downstream agitators. Any number of agitators also may be used across the width of the belt. In the preferred embodiment, the agitators are positioned side by side, in pairs, across the width of the belt, and the area agitated by each agitator overlaps the area agitated by its adjacent paired agitator. The paired agitators are spaced along the full length of the conveyor belt, as has been described. Each agitator may rotate in either the same or in the opposite direction from that of the agitators adjacent to it across the width of the belt and along the length of the belt. In the preferred embodiment, the agitators in each pair across the width of the belt rotate in opposite directions. It is contemplated that many types of agitators would work with the present invention. For example, a horizontal agitator with blunt attachments that tended to scoop and stir the curds, instead of the sharp finger-like attachments currently used with horizontal agitators, would produce stirred curd cheeses. Similarly, agitators with an axis of rotation that is angled into the curds, rather than strictly perpendicular to the belt, would be within the scope of the present invention. Such agitators could be mounted either to the sides or top of the food processing device. It is contemplated that other agitator configurations also may be suitable to practice the present invention, so long as the agitators stir the curds without physically damaging them. In the preferred embodiment, however, each agitators has an axis of rotation that is oriented generally vertically with respect to the plane of the upper surface of the material being processed, and most preferably the axis of rotation is perpendicular to the upper surface of the material being processed. This embodiment is preferred because it allows effective stirring, and thus produces the most uniform mixing of the curds. Any agitator with a generally vertical axis of rotation is suitable to practice the invention, regardless of the agitator's configuration and regardless of whether it has a vertical member. In the preferred embodiment, each vertical agitator comprises a horizontal member that is held in place above the curds by a fixed axis vertical support member attached to drive means. Each generally vertical agitator may have any suitable attachments that stir the curds without physically damaging them. In the preferred embodiment, the attachments comprise forward and rearward prongs. The prongs revolve about the agitator's generally vertical axis of rotation. As used herein, "revolve" means either "rotate" or "revolve." The forward prongs curve as they approach the belt so that the bottom end of each forward prong points in the direction that the prong is travelling, thus enabling the prong to scoop curds from the belt surface without physically damaging them. As depicted in the figures submitted herewith, the forward prongs are made of rods, and thus have circular cross-sections. In the preferred embodiment, the forward prong has a rectangular cross-section, with the wide portion of the prong being parallel to the belt. A suitable dimension for the cross-section of this forward prong is roughly two inches by one-half inch. The tip of the forward prong is rounded so as not to damage the curds. The rearward prongs also may have any suitably shaped cross-section, but a circular cross-section is preferred. The rearward prongs extend into the curds, thus stirring them and breaking up clumps as the vertical agitator rotates. The forward and rearward prongs may be arranged in any manner and number. In the preferred embodiment, the rearward prongs are closer to the agitator's axis of rotation than are the forward prongs. It may be desirable in some applications, however, to alternate or otherwise arrange the forward and rearward prongs from the agitator's axis of rotation outward to the edge of the agitator's reach. The prongs also may be provided in any number, as long as there is at least one prong, either forward or rearward, on each agitator. In the preferred embodiment, more than one grouping of prongs will be operably connected to the agitator's axis of rotation, and each grouping will comprise one forward prong and more than one rearward prong. Any suitable drive means may be used for the agitators. In addition, any desired ratio of drive means to agitators may be used; the ratio may vary anywhere from having all agitators driven by a single drive means to having each agitator driven by its own dedicated drive means. In the preferred embodiment, multiple drive means are used. More specifically, the device uses one drive means for each pair of vertical agitators. Also in the preferred embodiment, a sealed, raised lip is placed on each generally vertical shaft to prevent fluids from leaking from the bearing or drive means into the food stream. In a preferred embodiment, a temperature sensor detects the temperature of the curds. This temperature sensor may be located anywhere, but preferably is located midway along the length of the housing. Also in a preferred embodiment, ventilation ducts are attached to the housing. In the most preferred embodiment, the temperature sensor is operably connected to the ventilation ducts, thus controlling the amount of airflow over the curds in accordance with the temperature of the curds, and thereby allowing the curds to be processed at the desired temperature. In addition, to assist in maintaining the proper moisture content of the curds, a moisture sensing device may be provided. The moisture sensing device informs the cheesemaker whether the curds' moisture levels are within proper parameters. In the preferred embodiment, the moisture sensing device is positioned toward the downstream end of the device. Various cleaning nozzles are located along the length of the belt. In a preferred embodiment, some take the form of spray balls, which are particularly suited to cleaning the inside of the housing, while others take the form of spray bars, which are particularly suited for cleaning the conveyor belts. Salt is dispensed into the tube apparatuses by a salt dispenser. The salt dispenser and tube apparatuses may be used to apply salt to any type of food being processed, and to any type of cheese being processed, whether of the stirred curd or milled varieties. It is to be noted that the salt dispenser and salt tube apparatuses may be used independently of the conveyor, the agitators, or both, but that there is a synergistic effect between the systems. In the preferred embodiment, a quantity sensor measures the quantity of curds on the belt. The quantity sensor may measure the quantity of curds by any suitable means, including by measuring either the depth or mass of curds on the belt. In the most preferred embodiment, the quantity sensor measures the depth of curds on the belt. The quantity sensor may be positioned anywhere on the housing, but preferably is positioned toward the downstream end of the housing, under the salt tube apparatuses. In the preferred embodiment, the quantity sensor is operably connected to the salt dispenser, and directs the salt dispenser to release an amount of salt appropriate for the quantity of curds being processed on the belt. The salt dispenser comprises a chamber member and other components described herein. It is connected to and receives salt from a salt hopper, and it dispenses the salt into the tube apparatuses. A supply of salt is provided to the salt hopper. To ensure that the salt flows freely from the salt hopper into the chamber member, the salt hopper has steep sides and a bin vibrator is attached to the sides of the salt hopper. A chamber member is positioned under the salt hopper, and an air inlet is attached to the side of the chamber member. In a preferred embodiment, a plurality of salt hoppers are used, and the inlets for the chamber members are connected so that only one filter is required. In the most preferred embodiment, four salt hoppers are used. The middle end opening of a Venturi pickup tee is connected to the lower end of the chamber member. A pump attached to a first end opening of the Venturi pickup tee pushes air that has passed through a high-efficiency filter into the Venturi pickup tee. Each tube apparatus consists of hollow tubes connected to a second end opening of the Venturi pickup tee. The tube apparatus's distribution ends are spaced over the food to be salted in a manner that ensures that the salt is applied uniformly to the food. In a preferred embodiment, each distribution end terminates in a duckbill-shaped portion, thus enhancing the even spreading of the salt. If the salt is being applied to food being processed on a conveyor belt, the duckbill ends ensure that the salt is spread evenly over the width of the belt. A vertically oriented dispensing wheel is located inside the chamber member. The dispensing wheel has a plurality of openings. In its preferred embodiment, the dispensing wheel has a plurality of teeth separated by large gaps. When the wheel turns, salt is moved from the top portion of the chamber member to the bottom. The Venturi pickup tee creates a partial vacuum in the lower portion of the chamber member, thereby pulling the salt from the lower portion of the chamber member into the airstream. The salt is carried into the chamber member in air that enters the system through the makeup inlets on the chambers. In the preferred embodiment of the invention, air is used to convey the salt. The pump will take the form of an air blower, and the fluid that enters the chamber members through the makeup inlets is air. Nevertheless, other fluids including water may be used to convey the salt in the present invention. It is contemplated that any source of suitable fluid will suffice to practice the present invention, and thus that the invention may be practiced without a pump when a fluid is used that is propelled by other forces, such as gravity or a municipal water supply. Drive means are attached to the dispensing wheel. The drive means preferably is a motor with a direct current proportioner. In a preferred embodiment of the present invention, a quantity sensor measures the amount of food to be salted. The quantity sensor is operably connected to the drive means and varies the rate at which the wheel turns, thereby controlling the amount of salt dispensed to ensure that the proper proportion of salt is applied to the food being processed. In the preferred embodiment of the invention, one tube apparatus will be provided for each salt hopper, with the tube apparatus connected to the salt hopper through the Venturi pickup tee, chamber member, and other components described herein. However, any ratio of tube apparatuses to salt hoppers may be used in the practice of the invention. For example, it may be desirable in certain applications to have a plurality of salt hoppers for each tube apparatus, and it may be desirable in other applications to have a plurality of tube ape ratuses for each salt hopper. A primary object of the present invention is to provide a machine for processing a stirred curd cheese that is closed to the atmosphere and that easily may be cleaned. Another object of the invention is to produce cheese curds that have been drained properly of whey, have been salted, have achieved a proper acidity level, are uniformly mixed, and are of consistent size. Further objects of the invention are to provide for consistent salt distribution, proper temperature control, consistent moisture control, and less generation of cheese fines. It is yet another object of the present invention to reduce costs for labor, maintenance, and space requirements. A further object of the present invention is to provide a salting apparatus that evenly distributes salt over the food being processed, and that applies an amount of salt that is in proportion to the quantity of food being salted. Still another object of the present invention is to provide a salting apparatus that has only minimal moving parts. These and other objects of the present invention will become apparent with reference to the drawings, the description of the preferred embodiment, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the present invention. FIG. 2 is a side elevational view with parts cut away to show the interior of the food processing device. FIG. 3 is a top view with some internal components shown in phantom. FIG. 4 is a fragmentary sectional view taken along line 4--4 in FIG. 3. FIG. 5 is a fragmentary sectional view taken along line 5--5 in FIG. 4. FIG. 6 is a fragmentary sectional view taken along line 6--6 in FIG. 3. FIG. 7 is a elevational side view of the salt dispenser and a front elevational view of a tube apparatus. FIG. 8 is a elevational side view of the salt dispenser. FIG. 9 is a sectional front view of the salt dispenser. FIG. 10 is a front elevational view of a curd sensor and of a tube apparatus mounted across the width of a conveyor belt. FIG. 11 is a fragmentary sectional view taken along line 11--11 in FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 depicts a food processing device 10 constructed in accordance with the present invention. The device 10 consists of an elongated housing 12. In the preferred embodiment, the housing is enclosed in order to control heat and moisture levels, keep out contaminants, and allow efficient internal mechanized cleaning. A curd and whey inlet 14 is attached to the front of the housing 12 to allow curds and whey to be dispensed into the device 10. A temperature sensor 16 is mounted midway along the housing 12 and is operably connected to ventilation ductwork 18, thereby controlling the amount of cool air that circulates into the device 10 to control the temperature of the curds. The temperature sensor 16 may be a side-mounted probe or, as shown in the preferred embodiment, a top-mounted infrared device. A presalt tube apparatus 20 is connected on top of the housing 12 toward the upstream end of the device 10 to allow salt to be applied to the curds at the beginning of the processing. Salt tube apparatuses 22 are connected to the top of the housing 12 toward the downstream end of the device 10, thus allowing the product to be salted toward the downstream end of the processing. In the preferred embodiment, each salt tube apparatus 22 is identical to each other and to presalt tube apparatus 20. Accordingly, reference may be made herein simply to a tube apparatus 20,22. Inspection ports 24 and lights 26 mounted above sightglasses (not shown) allow the user to view the processing taking place inside the device 10. Access ports 28 allow manual access to the inside of the device 10. The housing 12 has reinforcing ribs 30 and support legs with adjustable feet 32. A moisture sensor 34 is mounted on top of the device 10. As shown in FIG. 2, each vertical agitator 36 is connected by a vertical shaft 38 to a final gear reduction box 40. A horizontal shaft 42 is attached to the bottom end of the vertical shaft 38, and forward prongs 44 and rearward prongs 46 are attached to the horizontal shaft. The forward prongs 44 are blunt. They are curved toward and located just above first conveyor belt 48 (the stirring belt) and second conveyor belt 50 (the salting belt). Line A represents the depth of the curds being processed on the belts 48, 50. The forward prongs 44 scoop the curds, while the rearward prongs 46 are dragged through and stir the curds. Sideboards 52, which are shown in phantom in FIG. 2, keep the curds on the conveyor belts 48, 50. The sideboards 52 are made of plastic or other easily cleaned, corrosion-resistant material. Any number of conveyor belts may be used with the present invention. In its preferred embodiment, food processing device 10 uses two conveyor belts, first conveyor belt 48 and second conveyor belt 50. The conveyor belts 48, 50 are positioned in a step-wise, overlapping fashion to ensure that all material is transferred from the first conveyor belt 48 to the second conveyor belt 50 as the curds and whey move through the processing stages. Each conveyor belt 48, 50 allows the whey to be drained from the curds, travels along belt carryways 54 and belt returnways 56, is tensioned by a gravity belt takeup 58 and takeup release arm 60, and is mounted on belt drive and idler shafts 62. A first belt scraper 64 is positioned at the second end (the downstream end) of first conveyor belt 48, and a second belt scraper 66 is positioned at the second end of second conveyor belt 50. The first belt scraper 64 and second belt scraper 66 ensure that the food is removed completely from the first conveyor belt 48 and the second conveyor belt 50. A photoeye 68, which senses curd accumulation in auger trough 70, is positioned at the second end of the second conveyor belt 50. Curds are collected in auger trough 70, and may be removed from the device 10 through curd outlet 72. A curd outlet auger 74 is located at the second end of the second conveyor belt 50 to aid in removing the processed curds. A moisture sensor 34 is positioned toward the second end of the second conveyor belt 50. Curd wash headers 76 are located at the first end of the first conveyor belt 48. A curd wash curtain 78 contains the liquid used in the curd wash. Vents 80 are located at the second end of the first conveyor belt 48, midway along the top of the device 10. At the first end of the first conveyor belt 48, an inlet deflector plate 82 is located next to the curd and whey inlet 14. The first end of the inlet deflector plate 82 is pivotally mounted on top of the curd and whey inlet 14. The second end of the inlet deflector plate 82 is held in place by an inlet deflector plate arm 84. Located below the inlet deflector plate 82 is a draining screen 86. In the preferred embodiment, the draining screen 86 is a commercially available wedge wire dewheying screen. A first ramp 88 and a second ramp 90 are located under that portion of the second conveyor belt 50 that is under the salt tube apparatuses 22. The first ramp 88 and the second ramp 90 slope toward a salty whey outlet 92, where whey is collected from the curds after they have been salted. The second ramp 90 meets a third ramp 94 at a peak 96. Sweet whey that falls on the third ramp 94 runs in the opposite direction from the salty whey collected on the second ramp 90, and is collected at a secondary sweet whey outlet 97. A fourth ramp 98 is positioned under the first conveyor belt 48 to collect the sweet whey drained from the curds on the first conveyor belt 48 at a main sweet whey outlet 100. Each of the ramps 88, 90, 94, 98 also is optimally positioned to ensure proper drainage of the cleaning and rinsing solutions that are used when the clean-in-place procedures for the device 10 are followed. Referring now to FIG. 3, it can be seen that each pair of vertical agitators 36 is driven by a single motor and primary gear reduction box 102. Each motor and primary gear reduction box 102 is operably connected to two final gear reduction boxes 40, one above each of two vertical agitators 36. It can be seen that each of the two vertical agitators 36 that are rotated by the same motor and primary gear reduction box 102 rotate in opposite directions, and each overlaps the area swept by the other. Each final gear reduction box 40 drives a single vertical agitator 36 and is suited to withstand lateral stresses imposed by the vertical agitator 36. As best seen in FIG. 3, in the preferred embodiment of the device 10 the vertical agitators are spaced closer together toward the front end of the device 10, where curds and whey are deposited on the first conveyor belt 48 by the curd and whey inlet 14. The curds cool as they move along the belts 48, 50, thus requiring less agitation from the vertical agitators 36. By increasing the spacing between vertical agitators 36 as the curds and whey proceed through the device 10, fewer vertical agitators 36 are required by the device 10, thereby reducing manufacturing and maintenance costs. The salting belt drive 104 drives the second conveyor belt 50, while the stirred curd belt drive 106 drives the first conveyor belt 48. The curd outlet auger drive 108 removes processed curds from the device 10. Referring now to FIGS. 4 and 5, a cross-sectional view of the device 10 is depicted. A sealed lip 110 is placed on each vertical shaft to prevent lubricating fluids from entering the housing 12 from the final gear reduction box 40. It can be seen in FIG. 4 that the paired horizontal shafts 42 are 90° out of phase, in that, when the horizontal shaft 42 of one vertical agitator 36 is parallel to the cross-section of the device 10, the horizontal shaft 42 of the other vertical agitator 36 is perpendicular to the cross-section of the device 10. The configuration of the forward prongs 44 and rearward prongs 46 on the horizontal shaft 42 most clearly can be seen in FIG. 5, which is a side view of only one end of the horizontal shaft 42. As depicted, the forward prongs 44 are moving to the right-hand side of the figure, thus scooping curds from the belt 50 without physically damaging them. The rearward prongs 46 are dragged through the curds, thus stirring the curds, also without causing physical damage. Referring now to FIG. 6, a cross-sectional view of the device 10 is depicted. Next to the belt is a catwalk 112. Mounted on top of the housing 12 is the ventilation duct 18. FIG. 6 also depicts the interaction between the two vertical agitators 36. Referring now to FIG. 7, a salt dispenser 114 is connected to the tube apparatus 20, 22. As can be seen in FIG. 8, an inlet filter 116 is connected to a pump 118 by a first connecting tube 120. The pump 118 is connected by a second connecting tube 122 to a high-efficiency filter 124, which is connected by a third connecting tube 126 to the first end opening 128 of a Venturi pickup tee 130. The Venturi pickup tee 130 also has a middle end opening 132 and a second end opening 134. Although a Venturi pickup tee 130 is used in the preferred embodiment of the invention, it is contemplated that other means for connecting the salt supply to the airstream also would be suitable. Furthermore, although inlet filter 116 and high-efficiency filter 124 are desirable and are used in the preferred embodiment of the present invention, the use of such filters is not necessary to practice the invention. The connecting tubes 120, 122, 126 also may be eliminated by connecting the components directly to one another or by other means without affecting the practice of the invention. A salt hopper 136 receives a supply of salt. In a preferred embodiment, the supply of salt is a polyhedral container capable of holding a quantity of salt therein. In the most preferred embodiment, the supply is a salt container 138 that is a generally rectangular solid directly coupled to the salt hoppers beneath it. If the supply is in the form of a salt container 138, a probe assembly 140 may be mounted on the side of the salt container 138. The probe assembly 140 has an element that detects when the salt level in the hopper has fallen too low. The probe assembly 140 also may have a second element that detects when the level of salt in the salt container 138 is at a maximum level. In an alternative embodiment, the probe assembly may be mounted directly on the side of the salt hopper 136. The salt hopper 136 has steeply sloped sides to ensure the salt flows freely. In addition, a bin vibrator 142 is attached to the side of the salt hopper 136. Drive means 144 also are attached to the side of the salt hopper 136. A platform 146 is located adjacent to the salt hopper 136 to provide access to the salt hopper 136. Referring now to FIG. 9, a chamber member 148 is mounted directly below the bottom of the salt hopper 136. The bottom of the chamber member is connected to the middle end opening 132 of the Venturi pickup tee 130. A makeup inlet 150 is attached to the side of the chamber member 148. In the preferred embodiment, where a plurality of salt hoppers 136 and thus a plurality of chamber members 148 are used, the makeup inlet 150 takes the form of a tube that connects each of the chamber members 148. Drive means 144 are operably connected to a dispensing wheel 152 located and vertically oriented within the chamber member 148. The dispensing wheel 152 has a plurality of large teeth 154, with large gaps 156 between the teeth 154. Air that enters the makeup inlet 150 first must pass through a makeup inlet filter 158. Referring now to FIG. 10, the tube apparatus 20, 22 comprises hollow tubes 160. The top end of the tube apparatus 20, 22 is connected to the second end opening 134 of the Venturi pickup tee 130. In a preferred embodiment, the hollow tubes 160 have branches 162, so that the tube apparatus 20, 22 has one hollow tube 160 at its top end, and then has branches 162 that separate the single hollow tube 160 at the top end of the tube apparatus 20, 22 into a plurality of hollow tubes 160 at the bottom end of the tube apparatus 20, 22. Each branch 162 diverges at the same angle from the hollow tube 160, thereby ensuring that the salt is evenly dispensed at the branch 162. In a most preferred embodiment, each tube apparatus 20, 22 has a branch 162 that yields two hollow tubes 160, each of which again has a branch 162 that yields two more hollow tubes 160, thereby making a total of four distribution ends 164 for each tube apparatus 20, 22. Each distribution end 164 terminates in a duckbill-shaped portion 166, thereby spreading the salt over a wide area. In the preferred embodiment, a quantity sensor 168 is positioned above the food to be processed on the conveyor belt 50. The quantity sensor 168 determines the quantity of the food on the conveyor belt 50 to be salted and is operably connected to the drive means 144, thereby ensuring that the amount of salt dispensed into the tube apparatus 20, 22 is in proportion to the quantity of food being processed. FIG. 11 depicts a cross-sectional view of the device 10. Vertical agitators 36, as well as the motor and primary gear reduction box 102 and final gear reduction boxes 40 that drive them, have been removed for clarity. When a plurality of tube apparatuses 22 are used, in the preferred embodiment of the invention they are staggered to ensure uniform coverage over the width of the belt 50. Nevertheless, it is contemplated that the invention may be practiced by arranging the tube apparatuses 22 in any suitable manner. A quantity sensor 168 is mounted above the curds to detect the quantity of the curds passing beneath the salt tube apparatuses 22. As shown in FIG. 11, various cleaning nozzles are located within the housing 12. Spray balls 170 are mounted from the top of the housing 12 along the length of the device 10 in order to clean the inside of the device 10. Spray bars 172 are located along the length of the device 10 on the inside of the belts 48, 50. Each spray bar spans the width of the device 10, and thus is well-suited to clean the belts 48, 50. A spray ball 170 and a spray bar 172 are depicted in FIG. 11, but have been omitted from the other figures to enhance clarity. The operation of the device 10 now will be described. A mixture of curds and whey is pumped from a processing vat through the curd and whey inlet 14 into the food processing device 10. The inlet deflector plate 82 spreads the curd and whey mixture so that it is distributed evenly onto the draining screen 86. The inlet deflector plate 82 may be adjusted so that its distance from the curd and whey inlet 14 is directly proportional to the rate at which the curds and whey are being introduced into the device 10. The position of the inlet deflector plate 82 is maintained by the inlet deflector plate arm 84. The draining screen 86 drains a substantial portion of the whey from the curd and whey mixture. The whey runs onto the fourth ramp 98 and is collected at the main sweet whey outlet 100. The curds and remaining whey travel along the first conveyor belt 48, where they are subject to a curd wash from the curd wash headers 76 and a the presalt from presalt tube apparatus 20. Additional whey and the curd wash liquid, in addition to whey extruded from the curds when the presalt causes the curds to contract, runs onto the fourth ramp 98 and is collected at the main sweet whey outlet 100. As the curds travel along the first conveyor belt 48, they are stirred by vertical agitators 36. Forward prongs 44 scoop while stirring, thereby avoiding physical damage to the curds and ensuring that the curds are processed into a uniform size. Rearward prongs 46 further stir the curds, also without physically damaging them. A temperature sensor 16 is mounted at the end of first conveyor belt 48 and operably connected to means for forcing cool air through the ventilation ductwork 18, thereby automatically ensuring that the curds are processed at the proper temperature. The conveyor belts 48, 50 may be operated at speeds from approximately 0.333 feet per minute (fpm) to approximately 2 fpm, with a preferred rate of speed of approximately 1 fpm. The vertical agitators 36 may be operated from approximately 7.5 rotations per minute (rpm) to approximately 30 rpm, with a preferred rate of 15 rpm. Upon reaching the end of the first conveyor belt 48, the curds and whey are deposited on the second conveyor belt 50. A first belt scraper 64 ensures that all curds and whey are removed from the first conveyor belt 48 and deposited on the second conveyor belt 50. Vertical agitators 36 continue to stir the curds as they travel along the second conveyor belt 50. Whey that is drained from the curds toward the first end of the second conveyor belt 50 runs onto the third ramp 94 and is collected at the secondary sweet whey outlet 97. After passing over the peak 96, salt is applied to the curds by a plurality of salt tube apparatuses 22. The salting causes further contraction of the curds, thus forcing out more whey. Whey that is separated from the curds after the curds pass the peak 96 runs onto the first ramp 88 and the second ramp 90 and is collected at the salty whey outlet 92. The moisture sensor 34 detects the moisture content of the curds near the end of the processing in the device 10. Adjustments thus may be made promptly if the curd moisture levels are not within the proper tolerances. Upon reaching the second end of the second conveyor belt 50, the fully processed curds are deposited into the auger trough 70. The second belt scraper 66 ensures that the processed curds are removed from the second conveyor belt 50. The processed curds may be removed from the device 10 through the curd outlet 72 with the aid of the curd outlet auger 74. In the event the curds begin accumulating in the auger trough 70, when they reach the height of the photoeye 68, the photoeye 68 will detect the accumulation and stop the device 10. While the curds are travelling through the device 10, salt is flowing from the salt container 138 into the salt hopper 136, which deposits the salt into the upper portion of the chamber member 148 and onto the dispensing wheel 152. The salt fills the gaps 156 between the teeth 154 of the dispensing wheel 152. As the dispensing wheel 152 is turned by the drive means 144, the salt is moved from above to below the dispensing wheel 152, where it then leaves the chamber member 148 and enters the middle end opening 132 of the Venturi pickup tee 130. The quantity sensor 168 measures the quantity of food being processed on the belt and sends a signal to the drive means 144, thus operating the drive means 144 faster as the quantity of food being processed on the conveyor belt 50 increases. At the same time, pump 118 pulls air through inlet filter 116, and then forces the air through the high-efficiency filter 124. The air then enters the Venturi pickup tee 130 through its first end opening 128, and leaves through its second end opening 134. As the air passes through the Venturi pickup tee 130, it creates a partial vacuum in the middle end opening 132 and in the chamber member 148. This partial vacuum sucks the salt into the middle end opening 132 of the Venturi pickup tee 130, where it then is conveyed in the airstream out the second end opening 134 of the Venturi pickup tee 130. A stream of air is provided to convey the salt from the bottom of the chamber member 148 into the middle end opening 132 of the Venturi pickup tee 130. This airstream enters the chamber member 148 through makeup inlet 150 after being passed through makeup inlet filter 158 After passing through the second end opening 134 of the Venturi pickup tee 130, the salt is conveyed into the hollow tubes 160 of the tube apparatus 20, 22. The salt is distributed evenly over the branches 162 and passes to the distribution ends 164, where it is spread by the duckbill-shaped portions 166 over the food being processed on the conveyor belt 48, 50. Although the description of the preferred embodiment has been presented, it is contemplated that various changes may be made without deviating from the spirit of the present invention. Accordingly, it is intended that the scope of the present invention be dictated by the appended claims, rather than by the description of the preferred embodiment.

1a

FIELD OF THE INVENTION The present invention relates to implantable medical devices. In particular, the invention is directed to a composite implantable medical device having an implantable tissue repair component and a component that assists in deployment of the tissue repair component at a surgical site and is subsequently removed by being bioabsorbed. BACKGROUND OF THE INVENTION Implantable medical devices designed to help repair damaged tissues have been successfully used for years. Some of these devices are used to patch damaged tissue and provide mechanical support to the tissues during healing. A simple form of these devices is a flexible patch-like sheet. The composition and morphology of the sheets are usually tailored to address a particular surgical need. In some cases, it is desirable to incorporate a reinforcing element into the flexible sheets. In addition to mechanical support, reinforcing elements often assist in handling and deployment of the implantable sheet devices. Ease of handling and deployment of flexible sheet devices are particularly desired when laproscopic instruments and procedures are used to implant the devices. An example of one of these devices is disclosed by de la Torre in U.S. Pat. No. 5,368,602. de la Torre describes a patch made of a surgical mesh material having one or more semi-rigid frame-like support elements permanently secured to the mesh material along all or part of the border of the material. The semi-rigid support members are said to enable manipulation and positioning of the entire mesh area with conventional laproscopic instruments. U.S. Pat. No. 5,695,525, issued to Mulhauser et al., discloses a semi-rigid framework in the form of a ring permanently attached to one side of a planar mesh material. The support ring is designed to prevent the planar mesh material from collapsing into crater-like defects in tissue by maintaining the mesh material in an expanded configuration across the defect site. A repair patch similar to the Mulhauser et al. device is disclosed in U.S. Pat. No. 5,824,082, issued to Brown. The Brown patch utilizes a framework made of a metallic support wire. The support wire has shape-memory properties. The support wire is permanently attached to a preformed patch material along its periphery. The shape-memory characteristic of the support wire enables the repair patch to be rolled into a small cylindrical profile at room temperatures and alter its configuration to expand and flatten the patch material at body temperatures. The repair patch is said to reside between layers of tissue at a repair site and not require sutures or staples. In U.S. Pat. No. 6,280,453, issued to Kugel et al., a hernia repair patch is disclosed having the form of a laminated mesh material with a framework made of a resilient monofilament spring permanently located between layers of the laminate. Once the patch is placed through an incision site in a hernia patient, the spring element assists in unfolding and expanding the patch into a planar configuration. The patch is provided with a pouch into which a surgeon can place a finger to position the patch across a hernia, rather than having to use a laproscopic instrument to position the patch. A variation on the theme of implantable tissue repair devices having permanently attached reinforcing frameworks is disclosed by Gianturco in U.S. Pat. No. 5,258,000. The Gianturco device is initially implanted as an unsupported flexible bag having an internal space into which an elastic stiffener wire is subsequently threaded. The stiffener wire causes the bag to adopt a flattened shape. The flattened repair device with its stiffener wire is permanently secured to tissue surrounding the repair site with sutures or staples. In surgical procedures that utilize a tissue repair material with a stiffener element, it may be desirable to remove the stiffener element from the repair material following at least partial attachment of the repair material to tissues of the repair site. In U.S. Pat. No. 5,370,650, issued to Tovey et al., an apparatus for positioning tissue repair meshes adjacent to body tissue is disclosed. The apparatus includes a delivery device with an arm that extends to place the tissue repair mesh into a surgical site. The arm has a stiffener element for the tissue repair mesh attached to its distal end. The tissue repair mesh is secured to the stiffener element with sutures sewn around the stiffener element and through holes in the mesh. The sutures can be sewn in such a way as to permit removal of the sutures from the tissue repair mesh following deployment. Prior to removal of the sutures from the mesh material, at least a portion the mesh material can be secured to tissues of the surgical site with sutures or staples. Once the tissue repair mesh is in place, the sutures holding the mesh to the stiffener element are removed. The delivery device is then separated from the tissue repair mesh and extracted from the surgical site. A pneumatically operated deployment device for a tissue repair mesh is disclosed in U.S. Pat. No. 6,302,897, issued to Rousseau. The Rousseau device is an applicator with a tissue repair mesh simply placed on an external surface of an inflatable bladder. The bladder has two portions. The first portion is filled with air. The second portion is initially empty, but is fillable with the air from the first portion when external mechanical pressure is applied to the first portion. As the second portion is inflated, the applicator and tissue repair mesh are unfolded and the repair mesh pressed against a patient's tissue. Following deployment of the mesh, the bladder is removed from the surgical site by hand. Farnsworth, et al. in U.S. Patent Publication No. 2004/0019360 disclose a tissue implant reinforced with a removable support member. The removable support member aids in placement and deployment of the tissue implant at an implantation site. The tissue implant and removable support member are both made of non-bioabsorbable materials. In some applications, it would be useful to eliminate the need to remove a reinforcing member from a tissue repair device or material. In U.S. Pat. No. 6,599,323, Melican, et al. disclose a bioabsorbable tissue implant reinforced with a component that can be bioabsorbable for use in pelvic floor repair. The tissue implant comprises one or more layers of a bioabsorbable polymeric foam having pores with an open cell structure. The tissue implant is in the form of a porous foam material. The foam component is integrated with the reinforcing component such that the pores of the foam component penetrate the mesh of the reinforcing component and interlock with the reinforcing component. Melican et al., teach implants, such as patches, made from non-bioabsorbable material are undesirable, however. None of these devices recognize the advantages of providing a non-bioabsorbable implantable sheet material with a resilient support member that is bioabsorbable. Such a device would have an adhesion scheme that permits the resilient support member to be initially held in place on the implantable sheet material with sufficient strength to withstand placement within and delivery from a laproscopic or similar surgical instrument. Yet the resilient support member would be removed from the implantable sheet material through a bioabsorption process and would not require further surgical procedures to remove the support member from the surgical site. The bioabsorbable resilient support member would assist in changing the implantable sheet material from a compacted configuration to a more planar configuration. The support member could also provide an unobstructed border area in which a complete set of sutures or staples encompassing the non-bioabsorbable repair material could be put in place and tested. Such a device would optionally include features that assist in tactile and visual orientation of the device at a surgical site. The bio-absorbable support member could be combined with bioactive compounds that would be released at the implantation site independently or in combination with bioabsorption of the support member. SUMMARY OF THE INVENTION The present invention is directed to a medical device for use in repair or reconstruction of damaged tissue as well as other surgical procedures. The device is particularly suited for repair of hernias and similar tissue damage requiring surgical placement and fixation of a patch-like material at the repair site. A bio-absorbable support member is attached to the patch-like device to enable a rolled device to unroll, or self-expand, at an implantation site without the need for an extrinsically applied force or a thermal transition of the support member material. The invention has two principle components. One component is an implantable device made of a non-bioabsorbable material, preferably in a planar form. The other component is a resilient polymeric support member made of a bioabsorbable material designed to assist in deployment and positioning of the implantable device at a surgical site. The bioabsorbable resilient support member is attached to the implantable device in such a way as to permit bioabsorption of the support member by the body of the implant recipient. The resilient support member is bioabsorbed by enzymatic action and/or hydrolysis of the polymeric material comprising the support member through physiological processes of the implant recipient. As a consequence, removal of the support member from the implantable device does not require a further surgical step, or procedure. The bioabsorbale resilient support member is also preferred in planar form. The combined planar materials are sufficiently pliable to permit the invention ( FIG. 4A ) to be rolled, folded, or otherwise compacted in form ( FIG. 4B ) and delivered with laproscopic instruments or other conventional surgical techniques. Following delivery of the invention to a surgical site, the bioabsorbable resilient support member readily recovers from the compacted form to substantially return to its original planar form. As the support member returns to its original planar form, the resilience of the support member causes the attached implantable device to readily change from the compacted form to the original planar configuration. As the invention assumes a planar form at a surgical site ( FIG. 4C , arrow ( 144 )), the bioabsorbable support member enables the implantable sheet material to be easily manipulated, positioned, and secured to tissues of the surgical site with surgical fasteners ( 146 ), which may be positioned by a surgical needle ( 175 ) ( FIG. 4D ). Once the implantable device is secured, the surgical procedure is concluded. In preferred embodiments, the bioabsorbable support member is sized to entirely cover the non-bioabsorbable implantable sheet material ( FIG. 3 ). In other embodiments, the bioabsorbable support member covers only part of the surface area of the implantable device ( FIGS. 2 , 2 A, 2 B, 5 - 7 , et al.). This leaves the border area of the implantable device exposed and available for fixation with sutures, staples, tacks, or other surgical fasteners. In these and other embodiments, the present invention can have letters, numbers, and other characters or features that aid in visual orientation of the invention with respect to a surgical repair site. A particularly preferred visual aid involves the use of different colors for the implantable device and the support member. In addition to the visual aids, the support member can be constructed to provide tactile distinctions between different sides of the invention as well as tactile distinctions between the implantable device and the support member. One embodiment of the present invention is a medical device comprising a resilient bioabsorbable support member, and an implantable non-bioabsorbable device attached to said resilient bioabsorbable support member, wherein said resilient bioabsorbable support member assists in deployment and placement of said non-bioabsorbable implantable device during implantation procedures without requisite for an extrinsically applied force. In addition, the polymeric material of the bioabsorbable support member does not undergo a thermal transition during deployment (i.e, expansion, unrolling, etc.) of the medical device. Although generally planar sheet materials are preferred in the present invention, filamentous materials in mesh, woven, or non-woven forms are also contemplated in the invention as well as composites thereof. The composites can be arranged so the bio-absorbable support member is placed on one or more surfaces of the tissue implant material. Alternatively, the bio-absorbable support member can be placed between two or more layers of tissue implant material. The layers of tissue implant material can be made of the same or different materials. The structure of these materials can be selected to influence bioabsorption rates of the polymeric material of the support member. For example, porous materials limit the rate at which a compound can move into and through pores of the material. A hydrophobic porous material, such as porous expanded polytetrafluoroethylene (ePTFE), also delays entry of aqueous fluids through the material to the hydrolyzable polymeric material of the support member. Delaying the contact of an aqueous fluid with the support member, delays bioabsorption of the support member. In addition to the composition, structure, and inter-relationship of these materials, the dimensions of the materials can be varied to achieve a desired bioabsorption profile. The bioasbsorption rate of the polymeric material of the support member can be further influenced by varying the geometry of particular parts of the support member. For example, a dimension of at least one portion of the support member can be tapered to present less polymer mass at one location than another location on the support member. Portions of the support member having less polymer mass are absorbed more easily and rapidly than portions of the support member with more polymer mass. The chemical composition of particular parts of the support member can also be varied to influence bioabsorption rates of the polymeric material. The bioabsorption rates of a non-blended hydrolyzable co-polymer suitable for use in the present invention can be influenced by the ratio and location of one polymer to the other polymer in the co-polymer in the polymeric chain. Different non-blended hydrolyzable co-polymers can be used in different portions of the support member. One embodiment is made from sheets each having a different non-blended hydrolyzable co-polymer composition. Pieces of each sheet are cut out and arranged together to form a support member of the present invention having regions, or zones, exhibiting different rates of bioabsorption. Of further note, coverings, geometric design and zones of differing copolymer ratios may be combined within the same device to achieve desired rates of bioabsorbtion and biological performance. Each embodiment of the present invention can have an anti-microbial agent associated therewith. Other features of the present invention will become apparent from the following detail description of the invention when taken in connection with the accompanying drawings. It is understood that the drawings are designed for the purpose of illustration only and are not intended as a definition of the limits of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates an isometric view of the present invention. FIG. 2A illustrates a perspective view of the present invention with a corner of the implantable sheet material folded up to show a smooth texture of one surface of the sheet material. FIG. 2B illustrates a perspective view of the present invention with a corner of the implantable sheet material folded up to show a roughened texture of one surface of the sheet material. FIG. 2C illustrates a perspective view of the present invention with reference characters in the border area of the implantable device. FIG. 3 illustrates an exploded view of the present invention where the support member and the implantable sheet material are essentially the same size. FIG. 3A illustrates an exploded view of the present invention. FIG. 3B illustrates an exploded view of the present invention with an adhesive agent applied between the support member and the implantable sheet material. FIGS. 4A-4D illustrate the present invention being compacted, unrolled, and afixed with surgical fasteners. FIG. 4G illustrates a cross-section of the present invention with a support member of sufficient thickness to provide a tactile step. FIGS. 5-7 illustrate different bio-absorbable support member configurations attached to implantable materials of the present invention. FIG. 8 illustrates a cross-sectional view of a vacuum-laminating press useful in making the present invention. FIG. 8A illustrates a cross-sectional view of a vacuum-laminating press useful in making the present invention. FIG. 9 illustrates two partial cross-sectional views of bio-absorbable support members of the present invention embedded or covered with another material. The additional material can effect bio-absorption rates of the support member and/or release rates of bioactive compounds incorporated into the invention. FIG. 10 illustrates a top view of a bioabsorbable support member of the present invention. FIG. 11 illustrates a top view of a bioabsorbable support member of the present invention. DETAILED DESCRIPTION OF THE INVENTION The preferred medical device of the present invention is a composite of a resilient bioabsorbable support member attached to a implantable sheet of flexible non-bioabsorbable polymeric material suitable for use as a tissue repair material. Both components of the preferred composite have a planar form. As seen in FIG. 2 , for example, the preferred implantable device of the present invention ( 140 ) is a generally planar sheet of flexible, tissue-compliant, non-bioabsorbable biocompatible polymeric material ( 142 ). Suitable polymeric materials include, but are not limited to, polypropylene, polyethylene, nylon, and polytetrafluoroethylene. The preferred polymeric material is an expanded, porous, polytetrafluoroethylene made according to U.S. Pat. Nos. 3,953,566 and 4,187,390, both issued to Gore. There are two implantable sheet materials that are most preferred. One most preferred implantable sheet material is a tissue repair patch made of porous expanded polytetrafluoroethylene (ePTFE) available from W. L. Gore & Associates, Inc., Medical Products Division, Flagstaff, Ariz. under the tradename GORE-TEX® DUALMESH® Biomaterial as part number 1DLMC04. The other most preferred implantable sheet material is a porous expanded polytetrafluoroethylene (ePTFE) material with an anti-microbial agent associated therewith. An antimicrobial treatment may be provided on the implantable sheet per, for example, U.S. Pat. No. 5,019,096 issued to Fox, Jr., et al. The final product is available from W. L. Gore & Associates, Inc., Medical Products Division, Flagstaff, Ariz. under the tradename GORE-TEX® DUALMESH® PLUS Biomaterial as part number 1DLMCP04. These most preferred materials have an oval shape with sizes in a range from 7.5 cm×10.0 cm to 26.0 cm×34.0 cm. Other planar shapes such as circles, squares, triangles, and custom-fitted shapes are also contemplated for use in the present invention. Regardless of the shape, suitable implantable sheet materials range in size from as small as 1.0 cm×1.0 cm to as large as 50.0 cm×50.0 cm, with 5.0 cm×5.0 cm to 40.0 cm×40.0 cm sized pieces being preferred, and pieces in a range from about 7.0 cm×7.0 cm to about 20.0 cm×20.0 cm being most preferred. Suitable polymeric materials for the bioabsorbable support member include, but are not limited to a block co-polymer of polyglycolic acid and trimethylene carbonate (PGA/TMC), polylactic acid/polyglycolic acid (PLA/PGA), or other homopolymers, copolymers, or polymeric blends derived from other biocompatible bioabsorbable monomeric components. Such homopolymers or copolymers can be comprised of varying amounts of one or more of the following monomer examples: glycolide, d,l-lactide, l-lactide, d-lactide, p-dioxanone (1,4-dioxane-2-one), trimethylene carbonate (1,3-dioxane-2-one), ε-caprolactone, gamma.-butyrolactone, delta.-valerolactone, 1,4-dioxepan-2-one, and 1,5-dioxepan-2-one. Other bioabsorbable polymeric constituents may include polyethylene glycol, polypropylene glycol, N-vinyl pyrrolidone, amino acids, anhydrides, orthoesters, phosphazines, amides, urethanes, and phosphoesters. Alternative copolymers may possess, in whole or in part, combinations of block, segmented, random, alternating, or statistical polymeric construction characteristics. The preferred polymeric material is a semi-crystalline segmented block copolymer of 67% PGA:33% TMC. The ratios of the PGA:TMC constituents can be adjusted during synthesis to alter the mechanical strength, bioabsorption rates, and processability of the co-polymer. The preferred polymeric material is PGA/TMC. The ratios of the PGA/TMC constituents can be adjusted during synthesis to alter the mechanical strength, bioabsorption rates, and processability of the co-polymer. Of particular significance with respect to the present invention is the ability of PGA/TMC co-polymers to change in shape from a compacted, or rolled, configuration to an uncompacted, or flattened, configuration without undergoing a thermal transition. Accordingly, devices of the present invention can be introduced, self-expanded, or unraveled, and secured at normal human body temperatures, or below. In some embodiments, the resilient bioabsorbable support member has a surface area less than the surface area of the implantable sheet material and lies within the perimeter of the implantable sheet material. This arrangement provides an unobstructed border area ( 144 ) on the implantable sheet material ( 142 ) that circumscribes the support member ( 100 ). The border area is available for sutures, staples, tacks, and/or other surgical fasteners. Useful border widths range from 0.3 cm to about 3.0 cm, with a preferred range from 0.5 cm to 2.0 cm, and a most preferred range between 0.8 cm to 1.2 cm. The resilient bioabsorbable support member preferably has the same outer dimensions as the implantable non-bioabsorbable sheet material ( FIG. 3 ). In the most preferred embodiment, a bioabsorbable support member having the pattern shown in FIG. 11 is sized to cover the entire surface are of a non-bioabsorbable sheet material without forming a border area. With resilient bioabsorbable support members having a thickness in a range from about 0.05 mm to about 2.0 mm, the thickness of the resilient bioabsorbable support member can serve as an important feature of the present invention. During laproscopic procedures, for example, a clearly perceivable tactile change is felt when manually operated surgical instruments ( 160 ) are moved across the surface of the resilient bioabsorbable support member and dropped off an edge of the support member onto the implantable sheet material ( FIG. 4G , arrow ( 162 )). A surgeon can take advantage of this “tactile step” to detect the border area of the implantable sheet material by feel. Knowing the location of the border area of the implantable sheet material permits the surgeon to confine placement of surgical fasteners to the border area and refrain from placing fasteners through the bioabsorbable support member. In addition to a tactile step, differences in surface characteristics between the implantable sheet material and the bioabsorbable support member material can also provide additional tactile feedback to a surgeon. These tactile characteristics include, but are not limited to, surface texture, hardness, and/or lubriciousness. Adhesion of the bioabsorbable support member to the implantable sheet material is preferably accomplished by softening the surface of the bioabsorbable support member that interfaces with the device through the application of solvents or heat. In addition to softening the bioabsorbable polymer material of the support member to attach the support member to the implantable sheet material, the bioabsorbable support member can adhered to the implantable sheet material with a bio-absorbable adhesive. Examples of the bio-absorbable adhesives include, but are not limited to, fibrin glue, collagen, a solution of polylactic acid-polyglycolic acid (PLA:PGA) copolymers carried in a suitable solvent and allowed to dry. Suitable bioabsorbable polymeric materials include, but are not limited to amorphous copolymers of PLA:PGA, or other homopolymers, copolymers, or polymeric blends derived from other biocompatible bioabsorbable monomeric components. Such homopolymers or copolymers can be comprised of varying amounts of one or more of the following monomer examples: glycolide, d,l-lactide, l-lactide, d-lactide, p-dioxanone (1,4-dioxane-2-one), trimethylene carbonate (1,3-dioxane-2-one), ε-caprolactone, gamma.-butyrolactone, delta.-valerolactone, 1,4-dioxepan-2-one, and 1,5-dioxepan-2-one. Other bioabsorbable polymeric constituents may include polyethylene glycol, polypropylene glycol, N-vinyl pyrrolidone, amino acids, anhydrides, orthoesters, phosphazines, amides, urethanes, and phosphoesters. Copolymers may possess, in whole or in part, combinations of block, segmented, random, alternating, or statistical polymeric construction characteristics. Adhesion is a complex subject involving combined mechanical and physico-chemical phenomena operating simultaneously with any given adhesive or adhesion scheme. Accordingly, no single theory is adequate to explain adhesion. Generally speaking, however, adhesives work by one of two mechanisms. The first mechanism is based on a thermodynamic model attributed to Sharpe and Schonhorn (L. H. Sharpe and H. Schonhorn, Chem. Eng. News 15:67 (1963)). The model is based on a belief that interatomic and intermolecular forces established at an interface between a substrate and an adhesive cause the adhesive to adhere to the substrate. The most common interfacial forces are thought to result from van der Waals and Lewis acid-base interactions. Adequate wetting of the substrate surface with an adhesive is another important aspect of forming adhesive bonds. With regard to the present invention, releasable adhesive bonds include formation of physico-chemical bonds between the bioabsorbable support member, the implantable sheet material, and the adhesive (or within the adhesive itself) that are capable of holding the substrate materials together during implantation procedures. The other adhesion mechanism is a mechanical interlocking, or anchoring, of an adhesive material with cavities, pores, asperities, or other surface topographies of a substrate material (J. W. MacBain and D. G. Hopkins, J. Phys. Chem. 29:88 (1925)). Porous materials may also have subsurface openings that become filled and interlocked with an adhesive material. Though distinct in theory, both of these mechanisms are operable in forming most adhesive bonds, albeit to different degrees. The support member component ( 100 ) of the present invention ( FIG. 2 , et seq.) is made of a resilient bioabsorbable polymeric material in generally planar form. The bioabsorbable support member can be constructed of a single material or plurality of materials in the form of a composite. The resilience of the bioabsorbable support member can be an inherent property of the polymeric material or supplied to the polymeric material with a framework structure. Shown in FIG. 9 are partial cross sectional views of support members 100 incorporating various framework structures. Shown are circular shaped framework structures 560 embedded within the support member 100 . Also shown are rectangular framework structures 562 and a square framework structure 564 , all embedded within the support member 100 , support structures 560 , 562 , 564 can have any cross section shape in order to supply resilience to the support member. For example, a bioabsorbable support member can have an essential, circular, oval, triangle, square, rectangle or other polygon cross section. The bioabsorbable support structure can also be formed from composites, laminates, weaves, yarns or other suitable forms. While various forms are contemplated for the resilient bioabsorbable support member ( FIGS. 5-7 ), the preferred form is illustrated in FIG. 11 . Another preferred form for the bioabsorbable support member is illustrated in FIG. 10 . Regardless of the shape and size of the bioabsorbable support member, the support member can be attached to either, or both, sides of a non-bioabsorbable sheet material. Additional material can be added to the present invention to alter the performance of the invention. For example, a layer of a porous hydrophobic non-biodegradable material such as ePTFE can be placed over the bioabsorbable support member as a barrier to aqueous fluids. Such a hydrophobic barrier would delay aqueous fluids from contacting and hydrolyzing the bioabsorbable support member. Delaying bio-absorption of the support member would allow the support member to function for a longer period as a support before loosing mechanical strength due to the bio-absorption process. In other embodiments, the bio-absorbable support material is coated with other polymeric materials that impact the mechanical strength of the support material and/or the absorption rate of the support material. Bioactive compounds can be incorporated into the bioabsorbable and/or non-bioabsorbable component of the present invention for release following implantation. Additional layers of materials could be used to control release rates of the bioactive compounds and/or absorption rates of the invention. These various features can be selected and combined in a single device to provide “programmed” rates of bio-absorption and bioactive compound release that are optimized for a particular application ( FIG. 9 ). EXAMPLES Example 1 This example describes the construction of a preferred embodiment of the present invention. Following formation of a non-bioabsorbable implantable sheet material, a bioabsorbable support member was attached to the implant as follows. The bioabsorbable support member was fabricated from a flat sheet of medical grade block co-polymer of polyglycolic acid-trimethylene carbonate (PGA/TMC) in a 67:33 ratio; respectively. The PGA:TMC copolymerization is achieved by a sequential addition ring opening polymerization of the cyclic trimethylene carbonate and glycolide dimer monomers. Synthesis of PGA:TMC can be conducted to produce copolymers in segmented and/or simple block form. Methods for PGA:TMC synthesis are described in U.S. Pat. Nos. 4,243,775 and 4,300,565 both to Rosensaft, et al and U.S. Pat. No. 4,429,080 to Casey, et al., each of which is incorporated herein by reference. Other desirable copolymeric ratios and/or block structures may necessitate the use of different variations in polymerization conditions and/or methods. Both glycolide and trimethylene carbonate monomers are available from BI Chemicals, Petersburg, Va. USA. A 33% weight to weight ratio of TMC to PGA segmented triblock copolymer may be obtained from United States Surgical, a unit of Tyco Healthcare Group LP, Norwalk, Conn. The flat sheet was cut into the pattern shown in FIG. 11 with a perforating CO 2 laser system (Laserage Technology Corp, Waukegan, Ill.). The bioabsorbable support member was sized to cover the implantable sheet material without a border area. An expanded polytetrafluoroethylene (ePTFE), 15 cm×19 cm oval hernia repair patch, tradenamed GORE-TEX® DUALMESH® Biomaterial available from the Medical Products Division of W. L. Gore & Associates, Inc. (Flagstaff, Ariz.) as part number 1DLMC04 was obtained. As seen in FIG. 2B , the GORE-TEX® DUALMESH® Biomaterial product ( 142 ) has a different texture ( 203 ) on each side of the sheet. One side ( 202 ) is designed to prevent or limit tissue adhesions or other tissue attachments thereto. The other side ( 203 ) is roughened to encourage tissue attachment or ingrowth of cells or cellular process therewithin. Once the ePTFE sheet was obtained and the bioabsorbable support member was fabricated, the two were attached by coating the interface surfaces with a solution of polylactic acid-polyglycolic acid (PLA:PGA) in a ratio of 85:15, respectively which was rendered into liquid form by dissolving in acetone. The GORE-TEX® DUALMESH® Biomaterial was oriented so that the “tissue adhesion barrier” side ( 202 ) was against the bioabsorbable support member ( 530 ). Though the bioabsorbable support member could have been placed on the non-tissue adhesion side of the GORE-TEX® DUALMESH® Biomaterial. Once the surfaces were coated, the components were pressed and held together between aluminum shims on a flat block ( FIG. 8 ). The assembly was allowed to dry overnight. The result was an implantable medical device of the present invention comprising a non-bioabsorbable implantable sheet material attached to a bioabsorbable support member that is self-expandable in situ without the need for an extrinsically applied force or a thermal transition of the support member material. Example 2 This example describes the construction of a resilient polymeric bioabsorbable support member attached to a non-bioabsorbable implantable sheet material having an anti-microbial treatment applied thereto. A bioabsorbable support member was constructed from a polylactic acid-polyglycolic acid co-polymer (PLA/PGA) having a weight percent ratio of 85:15, respectively. An implantable ePTFE sheet material with an anti-microbial treatment was obtained from the Medical Products Division of W. L. Gore & Associates, Inc., Flagstaff, Ariz. under the tradename GORE-TEX® DUALMESH® PLUS Biomaterial as part number 1DLMCP04. The dimensions of both components were the same so the bioabsorbable sheet member covered the implantable sheet material. The bioabsorbable support member was attached to the implantable sheet material by placing the two component together under restraint and exerting moderate pressure (e.g., 20-50 psi) in an apparatus ( FIG. 8A ) to the combination. The combination was heated to a temperature between 110 degrees and 125 degrees centigrade for approximately five (5) minutes. Upon cooling of the combination under restraint and removal from the apparatus, the result was an implantable medical device of the present invention comprising a non-bioabsorbable implantable sheet material with anti-microbial properties attached to a bioabsorbable support member that is self-expandable in situ without the need for an extrinsically applied force or a thermal transition of the support member material.

1a

The present patent document claims the benefit of the filing date of DE 10 2007 001 181.6, filed Jan. 5, 2007, which is hereby incorporated by reference. BACKGROUND The present embodiments relate to an imaging system for capturing an image sequence. During a number of medical applications (e.g. an endoscopic intervention), a patient is irradiated over a period of time for imaging purposes. The patient is continuously exposed to ionizing radiation during this time. During lengthy treatments, such continuous exposure results in radiation damage, such as reddening of the skin and other tissue damage. Medical personnel, such as the doctor carrying out the treatment and/or the medical personnel assisting the doctor may be in close proximity to the patient during the treatment. The medical personnel may be exposed to continuous stray radiation during the treatment. Conventially, exposing the patient and the medical personnel to radiation in this way was regarded as acceptable in view of the medical benefit. Alternatively, the radiation dose was reduced, even though this adversely affects the image quality of the x-ray images obtained, as the image sharpness depends on the radiation dose. The radiation dose cannot therefore be reduced arbitrarily. SUMMARY AND DESCRIPTION The present embodiments may obviate one or more drawbacks or limitations inherent in the related art. For example, in one embodiment, patient imaging is performed in a non-damaging manner for capturing an image sequence over a period of time, the images obtained being characterized by high image quality. In one embodiment, a method for capturing an image sequence includes taking a reference image using a high radiation dose of a radiation source; the references image is stored; taking another current image using a lower radiation dose; and comparing the reference image with the current image. If, on the basis of the comparison, a change is detected in the current image, another image is taken using a high radiation dose. The method may used by a medical imaging device, such as an x-ray machine. When capturing an image sequence, non-damaging imaging may be achieved by taking individual images using a high radiation dose instead of continuously applying a high radiation dose to the patient. This provides high-resolution (i.e. highly detailed) images that can be used as the comparison basis for detecting a movement or change in the patient's body. Such an image is, for example, the reference image which is followed by at least one current image that was taken using a lower radiation dose. The radiation dose of the current image is set such that the image quality is adequate for comparison with the reference image. A computer may automatically compare the reference image with the current image. The computer may detect dynamic processes resulting in a change in the current image compared to the older reference image. Only if such a change is detected will another image, which will replace the reference image, be taken using a high radiation dose. The replacement reference image will provide the medical personnel with an updated high-quality visualization of the processes in the patient's body. The imaging method may be used with a flat-panel x-ray machine and/or a computed tomography (CT) scanner. The other image may not be a complete image, which reproduces the entire body region under examination depicted in the reference image. The other image may be a sub-area of the complete image. Only an image detail is captured with a high resolution. The image detail corresponds to the area of the current image in which the change was detected. The static areas are not continuously exposed to the full radiation, but only the areas in which changes are discernible are repeatedly captured using a high radiation dose. The image detail may be inserted in the reference image at the position where the change was detected. This provides a complete current image with a high degree of sharpness, with only a small part of the patient's body having been exposed to the high radiation dose in order to update the reference image by the image detail. Suitable computer-based image processing techniques may be used to replace an image detail of the reference image by the image detail subsequently obtained. The image made up of the image detail and the reference image may be stored as the updated reference image and used as the reference image for the comparison. The stored image may be used in an iterative loop. After detection of a movement or change by the current image, the reference image may be immediately adapted automatically so that a high-quality current recording of the body region under examination is available. In one embodiment, to capture the image detail, a beam path of the medical imaging device is restricted by a collimator. The collimator may mask out part of the beam path, which reduces the radiation dose to which the patient is exposed. Using the part of the beam path passing through an aperture of the collimator, a high-quality recording of the region in which a change was detected in the current image can be obtained. In one embodiment, the collimator may be moved automatically based on the change detected. The collimator may be set to image a plurality of details and positions. The method may be characterized by a particularly high degree of automation so that the method is carried out quickly. The collimator may be moved to a number of predetermined positions. The number of predetermined positions is correlated with the size of the collimator aperture. Image details may be captured from all the predetermined positions, so that the contiguously disposed image details cover the entire image. For example, four defined collimator positions are provided which are matched to the size of the collimator aperture. The collimator may be moved to one of the four positions, so that one quadrant of the reference image may be taken in each case. Establishing the predefined positions enables the collimator to be controlled in a particularly simple manner. In one embodiment, at least the reference image is visualized on a display. A high-resolution current image may be displayed in real time. In one embodiment, the further image is taken if a predefined threshold value is exceeded when comparing the reference image with the current image. The threshold value represents a limit value of a visualization parameter, such as a predefined grayscale value, which visualization parameter is taken into account for comparing the reference image with the current image. The threshold value may be set by an imaging device operator. The sensitivity of a processing unit may be modified for evaluating the comparison result. The radiation dose may be set using a control unit of the medical imaging device. The medical imaging device includes an x-ray generator for producing the beam path. The control unit of said x-ray generator automatically adjusts the intensity of the x-ray radiation, for example, the size of the radiation dose, based on the comparison of the reference image with the current image. Recordings with high or low image sharpness are accordingly obtained. The medical imaging device may be, for example, an x-ray emitter. The current image may be taken with a radiation dose that may be less than 50% and, more preferably 25%, of the size of the radiation dose of the reference image. The radiation dose of the current image may be lower than the radiation dose of the reference image, however, it is sufficient for showing the relevant differences between the current image and the reference image in the specific application and using suitable methods. This may provide a particularly non-damaging patient imaging method in which the radiation dose for the patient is reduced. In one embodiment, an imaging apparatus includes an imaging device with a radiation source and a detector, a control unit and a processing unit. The processing unit compares a stored reference image taken using a high radiation dose with a current image taken using a low radiation dose. The control unit triggers the imaging device to take another image with a high radiation dose on the basis of the comparison. The components of the apparatus may be interconnected by a data link so that the imaging device is automatically triggered depending on the comparison result. The processing unit processes a software-based combination of mathematical and logical operations which enables the difference of the values of the visualization parameter (e.g. grayscale value) to be taken for each point of the reference image and of the current image, so that any exceedance of the predefined threshold value of the visualization parameter can be interpreted as a change. The processing unit may be part of the control unit, but can also constitute a separate entity connected to the control unit via a data link. If a change is detected, the control unit may automatically send a control signal to the imaging device to take the further image which will provide more precise information about the change than the current image. In one embodiment, the imaging device may include a collimator that restricts a beam path of the radiation source when the further image is taken. The collimator may be adjusted automatically by the control device in order to obtain a recording of a particular image detail. In one embodiment, the processing unit inserts the image detail into the reference image and stores the updated reference image. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 schematically illustrates one embodiment of an imaging apparatus, FIG. 2 a shows a block diagram of a method for capturing an image sequence, FIG. 2 b schematically illustrates one embodiment of a collimator, and FIG. 2 c shows a radiation dose and a dose-area product over time for the individual steps according to FIG. 2 a. DETAILED DESCRIPTION In one embodiment, as shown in FIG. 1 , an imaging apparatus 2 includes an imaging device 4 with a radiation source 6 , a radiation detector 8 , and a collimator 10 . The imaging device 4 may be an x-ray machine. The apparatus 2 may be controlled by a control unit 12 that includes a processing unit 14 . A patient 18 positioned on a patient positioning table 16 may be moved into a beam path 20 emitted by a radiation source 6 . A series of recordings of a region under examination of the patient 18 may be made using the imaging device 4 . An image sequence may be recorded during a medical intervention with continuous irradiation of the patient 18 . A method for capturing an image sequence is shown in the block diagram of FIG. 2 a . A reference image B R with high image sharpness is taken with a high radiation dose D H (see FIG. 2 c ). The reference image B R may be stored and/or displayed on a display 22 . The display 22 provides the treating physician with visual assistance during the medical intervention. A series of current images B A of the entire region under examination may be taken. The current images B A may correspond to the reference image B R with respect to their size and position relative to the patient. A lower radiation dose D N is used. For example, the current images B A are less sharp. The processing unit 14 may automatically compare each of the current images B A with the reference image B R in respect of a visualization parameter, for example, the grayscale value of each image pixel. A predefined adjustable threshold value may be used for the comparison. If the two images coincide, for example, if the changes in the current image B A are below the threshold value, a further current image B A is taken. If changes exceeding the threshold value are detected in the current image B A compared to the reference image B R , depending on the position of these changes, an image detail 24 is captured using a high radiation dose. In the current image B A according to FIG. 2 a , the changes are in a first quadrant I of the image B A . The control unit 12 accordingly controls the collimator 10 to mask out part of the beam path 20 . Only the first quadrant I is captured as an image detail 24 . The size of an aperture 26 of the collimator 10 may be adjusted so that only a quarter of the total image, such as the first quadrant I, is captured. The image detail 24 is then automatically inserted into the reference image B R , for example, at the position where the change was detected. For example, the image detail 24 is inserted in the first quadrant I of the reference image B R . An updated reference image B R may be obtained, stored, and simultaneously displayed on the display 22 . The updated reference image B R may be used as the basis for comparison with the subsequent current images B A . FIG. 2 c shows a radiation dose D and a dose-area product P. FIG. 2 c shows radiation dose per irradiated area over time t. The item instants t 0 to t 6 specify the times where the acts of the method are carried out. When the reference image B R is taken, a high radiation dose is used. The high radiation may be about 100% of the radiation dose D. The beam path 20 may remain unrestricted when the reference image B R and the current image B A are taken, so as to produce a maximally large-area complete image, as shown in FIG. 2 b . As the reference image B R has a size which is defined as maximally large, the dose-area product P may remain 100%. When the current image B A is taken, a much lower radiation dose D is used. The lower radiation dose D may be about 25% of the maximum possible radiation dose D H . The radiation dose D is regulated via an x-ray generator (not shown in greater detail here) of the x-ray device 4 . The generator may be controlled via the control unit 12 . The current image B A may be as large as the reference image B R . The dose-area product P may be only about 25% based on the low radiation dose D N . In one embodiment, the collimator 10 is not used to screen off the beam path 20 , apart from the first quadrant I in which a change was detected, until capture of the image detail 24 at time t 4 . To capture the image detail 24 , a maximum radiation dose D H is used. As the image area is restricted to a quarter of the total image area in this case, the dose-area product is only 25%. As shown in FIG. 2 c , this method is particularly non-damaging for the patient, while at the same time the images displayed to assist the medical personnel have optimum image quality. While the invention has been described above by reference to various embodiments, it should be understood that many changes and modifications can be made without departing from the scope of the invention. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.

1a

[0001] This application claims priority to U.S. Patent Application Ser. No. 61/333,403, filed May 11, 2010. BACKGROUND OF THE INVENTION [0002] The invention relates generally to drying of plant material and, more specifically, to a novel, non-obvious process for drying of plant material to maintain a high content of a labile bio-active molecule. [0003] Rosmarinic acid (RA) is an ester of caffeic acid and 3,4-dihydroxyphenylacetic acid. It is also a secondary metabolite of various plant species including those of Lamiaceae. Spearmint ( Mentha spicata L.) is particularly known as a major source of carvone-rich essential oil for perfumery and flavoring industries and is grown worldwide. It is a fast growing perennial that can biosynthesize significant amounts of RA and other phenolics when selected to do so (Fletcher R S, McAuley C and Kott L S. 2005a. Novel Mentha Spicata clones with enhanced rosmarinic acid and antioxidant activity. Proc. WOCMAP III, Vol. 6 : Traditional Medicine and Nutraceuticals Ada Horticulture. 6S0, ISHS. pp 31-40 SA-08-06337; Fletcher R S, McAuley C and Kott L S. 2005b. Heat stress reduces the accumulation of rosmarinic acid and the antioxidant activity of Spearmint ( Mentha spicata L.). Journal of Science of Food and Agriculture 85:2429-2436 SA-09-06343). There is an interest in developing products based on the more polar RA extracted from spearmint that will likely have greater antioxidative efficacy than carnosic acid in beverages, sauces, and emulsions. In addition, this molecule is known to have unique properties including antiviral, antibacterial, and anti-inflammatory activities (Mazumder A, Neamati N, Sunder S, Schulz J, Pertz H, Eich E, and Pommier Y. 1997. Curcumin analogs with altered potencies against HIV-1 integrase as probles for biochemical mechanisms of drug action. Journal of medical Chemistry. 40:3057-3063; Szabo E, Thelen A and Paterson M. 1999. Fungal elicitor preparations and methyl jasmonate enhance rosmarinic acid accumulation in suspension cultures of Coleus Blumei. Plant Cell Reports 18: 485-489; Hooker C W, Lott W B and Harrich D. 2001. Inhibitors of human immunodeficiency virus Type 1 reverse transcriptase target distinct phases of early reverse transcription. Journal Virology. 75: 3095-3104). [0004] Spearmint like many other herbs is highly seasonal in nature and has high levels of moisture. In order to preserve this highly perishable biomass source, and make it available year round for extraction, a post-harvest technological treatment of tissue such as drying and/or freezing is required. In general, aromatic herbs and spices are the most sensitive to any post harvest processing including drying or freezing techniques which increase the biological deterioration of tissue. Such treatments results in the loss of volatiles and flavors, changes in the color and texture, and decreases in the nutritional value. [0005] Drying is one of the oldest preservation techniques. Natural drying (drying in the shade) and hot air drying are still the most widely used methods. However, these methods have several disadvantages and limitations; for instance, they require relatively long duration and high temperatures for optimum drying. The contact of dried material with hot air causes rapid degradation of important flavor compounds and nutritional substances, as well as color alteration. Another disadvantage of this method is tissue shrinkage, which results in tissue collapse thereby reducing the available biomass. Freeze-drying is a technique by which material is frozen, and then dehydrated under vacuum; a process by which the contained water passes from a frozen to a gaseous state. Although freeze drying is an excellent method from a quality standpoint, the drying process requires more time and specialized equipment, resulting in high energy and capital costs. [0006] Compared to air drying, hot air drying and freeze drying, microwave or hybrid microwave drying techniques (microwave-hot air drying; microwave-freeze drying, microwave-vacuum drying; osmotic pretreatment before combined microwave-hot air drying) can greatly reduce the drying time of the biological materials while maintaining quality. There has been extensive research into microwave drying techniques, particularly on drying fruits and vegetables (Bouraout M, Richard P and Durance T. 1994. Microwave and convective drying of potato slices, Journal of Food Process Engineering 17: 353-363; Tulasidas T N, Ratti C and Raghavan G S V. 1997. Modelling of microwave drying of grapes, Canadian Agricultural Engineering 39:57-67; Funebo T and Ohlsson T. 1998. Microwave-assisted air dehydration of apple and mushroom, Journal of Food Engineering 38 (3):353-367). The introduction of a microwave drying/heating technique which reduces drying time considerably and produces a high-quality end product offers a promising alternative and a significant contribution to the herb processing industry. Although microwave drying is a rapid technique, the tissues are not evenly dried due to the non-uniformity in temperature distribution (Vadivambal D S and Jayas R. 2007. Changes in the microwave treated agricultural products—a review. Biosystems Engineering. 28:1-16). [0007] Vacuum-microwave drying offers an alternative way to improve the quality of dehydrated products. The low temperature and fast mass transfer conferred by vacuum, combined with rapid energy transfer of microwave heating, generates very rapid, low-temperature drying. Due to the absence of air during drying, the structure, color and sensory qualities of products can be better preserved. Vacuum-microwave drying requires a large capital investment but has been successfully used in the dehydration of fruits and vegetables (Vadivamabal et al.). [0008] In a recent study, different drying techniques such as convective drying, sun drying, room air drying and solar drying (using polythene tent dryer) were carried out in spearmint for comparison of rehydration characteristics, color, oil content and drying ratio (Parminder K, Satish K, Sadhana A, Neena C, and Manpreet S. 2009. Influence of different drying techniques on quality of spearmint ( Mentha spicata L.). Journal of Food Science and Technology. 46(5): 440-444). In this study, conventional air dried mint samples had higher oil content compared to convective dried samples, particularly at higher temperatures. Retention of green color was higher in convective dried compared to conventional dried samples at higher temperatures. In a study (Fletcher et al.; 2005b) to understand the effect of heat stress on growing spearmint plants, high temperature drying (80° C.) was found to significantly reduce the total phenolics (up to 87%). This study also indicated that the RA levels were not significantly reduced when tissue was dried at low temperature first (35° C.) followed by high temperature drying. [0009] Several scientific reports exist on improved microwave drying methods for fruits and vegetables in the processing industry (Vadivamabal et al.). However, little information currently exists on direct microwave drying of leafy herbs and among the available reports, as all of them mainly focus on using vacuum-microwave drying technique. The effect of drying methods such as conventional drying, solar drying, oven drying and microwave-vacuum drying on volatile compounds has been investigated in thyme ( Thymus vulgaris L.), sage, oregano ( Origanum sp), and rosemary ( Rosmarinus officinalis L.) (Balladin D A and O. Headley O. 1999. Evaluation of solar dried thyme ( Thymus vulgaris L.) herbs, Renewable Energy 17: 523-531); Venskutonis P R, Poll L and Larsen M. 1996. Influence of drying and irradiation on the composition of the volatile compounds of thyme ( Thymus vulgaris L.), Flavour and Fragrance Journal 11: 123-128;). All of these studies indicated that higher temperatures and long duration of exposure reduced the levels of the essential volatile compounds in these herbs. No scientific reports exist on drying kinetics of spearmints, especially for the purpose of commercial extraction and stability of phenolic compounds by comparing different drying techniques. The ability to rapidly dry leaf biomass while at the same time maintaining optimal levels of the temperature labile target molecule, rosmarinic acid, would be a major breakthrough in the use of this plant species for phytochemical production. [0010] There is, accordingly, an interest in developing a suitable drying process of spearmint biomass which would retain the highest levels of rosmarinic acid. The ideal drying technique would permit early harvest, lighter weight for transportation from multiple locations and less space for long term storage of biomass without deterioration to allow for year-round extraction. SUMMARY OF THE INVENTION [0011] The invention consists of the controlled use of energy to remove the water from plant material while maintaining a high amount of a heat labile constituent. In a specific example, microwave energy is applied to freshly harvested mint to remove water from the plant material without destroying significant amounts of rosmarinic acid present in the mint. The method permits the rapid and efficient drying of large quantities of plant material, reducing both the weight and volume of the plant material for reduced transport and storage requirements while retaining the heat labile constituent in high amounts for later extraction. BRIEF DESCRIPTION OF THE FIGURES [0012] FIG. 1 is a graph of relative water content as a function of drying time using a dehydrator. [0013] FIG. 2 is a graph of the effect of temperature and duration of drying on RA content using the dehydrator. [0014] FIG. 3 is a graph of relative water content and RA levels as a function of sample weight during microwave drying. [0015] FIG. 4 is a graph of relative water content and RA levels as a function of sample weight during freeze-drying. DESCRIPTION OF THE INVENTION [0016] Rosmarinic acid (RA) is a potent phenolic antioxidant found in various plant species including spearmint ( Mentha spicata L.). An effective method for drying spearmint tissue which retains high levels of RA is crucial for viable commercial RA production. A study was conducted to determine the efficiency of three different drying methods of spearmint tissue such as freeze drying, conventional hot air drying and microwave drying. Four different durations of drying using a freeze dryer, twelve different temperature-duration combinations using a conventional dehydrator (hot air drying), and eight different durations of drying using a microwave were tested. The effects of drying methods on relative water content, tissue color and RA levels were evaluated. In a conventional dehydrator and the freeze-dryer, the lowest stable moisture levels (<10%) of dried spearmint tissue were reached at 48 h. On the other hand, a stable moisture level was reached within 2.5 minutes of drying with a microwave. The changes in the RA levels of the tissue were dependent on the method of drying, the duration of drying and the temperature used for drying. Air-dried samples and dehydrator dried samples of spearmint tissue were less green and exhibited lower RA levels compared to microwave dried and freeze-dried samples. The RA levels of tissue that was air-dried at room temperature (RT) or dehydrator dried beyond 48 h decreased as the duration of drying was increased. However, using the dehydrator, at very high temperatures (≧57° C.), the RA levels were reduced by up to 80% at 24 h of drying. The optimum drying time using a microwave at which the highest level of RA retained coupled with the lowest tissue shrinkage was 2.5 minutes. The freeze dried samples retained the highest level of RA irrespective of drying time with the lowest amount of tissue shrinkage compared to all other methods. However, microwave drying seems to be the most efficient way of drying spearmint tissue in a short time with retention of high RA levels, desirable tissue color and density. [0017] While microwave energy is used in a preferred embodiment of the present invention, the invention includes the use of other types of energy and processes that would also achieve the objectives of drying fresh plant material while retaining an economical amount of a labile compound present in the plant material. For example, infrared dryers and fluidized beds are known in the art for efficient drying of plant materials under appropriate conditions. Example 1 Materials and Methods [0018] Plant Material and Sample Collection. A proprietary spearmint line capable of rapid regrowth and accumulation of high RA levels was chosen for this study. Clones of this line were established at a greenhouse during winter months (November-January) under supplemental illumination. Samples for this study were taken by clipping the top 4-6 cm of the plants that were comprised of young new leaves with smaller stems. The initial fresh weight of each replicate of spearmint tissue sample used for different drying methods was 5±0.05 g. [0019] Drying Methods: Drying experiments were carried out using three different drying processes: conventional dehydrator, conventional microwave and freeze-dryer. [0020] (a) Conventional dehydrator: Leaf tissue was dried using the standard vegetable dehydrator (Open Country—Sportsman Kitchen) in three replicates for each treatment. Pre-weighed leaf tissue was spread as a thin layer on the trays of the dehydrator. Three different drying temperatures in the dehydrator (35° C., 41° C. and 57° C.) were set for drying the tissue samples. In addition the tissue was also dried at room temperature (RT) as a control. The tissue for these four different temperatures was dried for 0 h, 24 h, 48 h, 72 h and 96 h. In total, 60 samples from three replicates of tissue dried at four different temperatures for five different time points were analyzed for the dehydrator process. Weights of each sample (post-treatment weights) were recorded for each treatment after drying for the set time and temperature. Relative water content in each sample after drying treatment was estimated as (post-treatment weight/pre-treatment weight)*100 and expressed as percentage (%). [0021] (b) Microwave: A programmable domestic microwave oven (GE-JES1656SJ-02) with maximum output of 1150 W was used for the drying experiments. In each of the drying experiments, 5±0.1 g of leaf tissue was uniformly spread on the turntable inside the microwave cavity, and allowed to turn for an even absorption of microwave energy. Samples were dried for eight different time periods (30 sec, 1 min, 1 min 30 sec, 2 min, 2 min 30 sec, 3 min, 3 min 30 sec, 4 min) at a randomly chosen 70% output power. Three replications for each treatment were performed according to the preset microwave output power. Tissue samples after each time point of drying were weighed immediately. Relative water content after each treatment was estimated as (post-treatment weight/pre-treatment weight)* 100 and expressed as %. [0022] (c) Freeze drying: A research level freeze-dryer was used for drying the spearmint tissue. Three replicates of tissue (5±0.1 g) were lyophilized for 0 h, 24 h, 48 h, 72 h and 96 h. Tissue samples after each time point of drying were weighed immediately. Relative water content after each treatment was estimated as (post-treatment weight/pre-treatment weight)*100 and expressed as %. [0023] Chemotyping: Leaves from each sample from all the three drying experiment (that includes all treatments of dehydrator, microwave and freeze-drying and air-dried samples) were ground manually using pestle and mortar. A rapid method for RA quantitation using HPLC as described below was used for all samples. All the samples for each drying method were compared with each other within the drying experiment and also between the drying experiments. [0024] Data analysis: Statistical analysis was performed on all data for each drying method separately using SAS 9.2. For the freeze drying and microwave drying method, the RA levels and weights for each treatment were analyzed by one way analysis of variance. A factorial design (temperature×duration) was used to analyze the dehydrator drying method. Fisher's least significant difference (LSD) obtained for each treatment and treatment combination was used to discriminate the means for comparison. Rosmarinic Acid Quantitation [0025] Chemicals and Reagents. RA reference standard (99.0%) was obtained from Sigma-Aldrich (Cat. #53,6954). Acetonitrile, ethanol, water, and o-phosphoric acid (85%), were HPLC grade and acquired from Fisher Scientific. [0026] Sample preparation method. Spearmint plant tissue was harvested in January and dried via the drying parameters described above [0017]-[0020]. The leaf and small stem tissue were ground using a mortar and pestle. Accurately weighed ca 10.25±0.25 mg of freshly ground spearmint tissue was placed into a tared 2.0 mL microfuge tube. Accurately transferred 1.8 mL of extraction solvent (20 mM KH 2 PO 4 (pH 2.5): ethanol (1:1 v/v)) was added to each tube and vortexed each for 1 minute. The 20 mM potassium phosphate solution (KH 2 PO 4 ) was prepared by dissolving 0.680 g potassium phosphate monobasic (HPLC grade) into a beaker with ca 450 mL water (HPLC grade), adjusted to pH 2.5 with a few microliters of phosphoric acid, transferred to a 500 mL volumetric flask and topped to volume with water. The microcentrifuge tubes were partially immersed in a room temperature (approx. 22° C.) sonication bath (Fisher Scientific, Model FS60D with a fixed power setting) without tube closures becoming submerged. Tubes were sonicated for 10 minutes followed by an additional minute of vortexing. The tubes were placed in a microcentrifuge and pelleted for 10 minutes at 9600×g. A portion of each supernatant was transferred to a syringe with filter (0.245 μm PTFE, 25 mm diameter) and syringe-filtered into amber autosampler vials and sealed with crimp caps. It was observed with prior use of nylon syringe filters that RA recoveries were reproducibly decreased. Evaluation of same-sample aliquots filtered through either PTFE or nylon media revealed ca 10% RA retention to nylon, so PTFE filters must be used to assure quantitative recovery from aqueous RA samples. [0027] Instruments and Conditions. All chromatographic analyses were performed using a combination of Agilent 1100 and 1200 series HPLC modules with diode array detector, quaternary pump, autosampler, column heater, and online degasser. Data were analyzed using the HPLC ChemStation™ LC3D software. The column was a LiChrosorb RP-18 (250×4.6 mm, 5 μm, Supelco) with a C18 guard (Supelco) and PEEK coupler. [0028] The mobile phase consisted of 0.1% o-phosphoric acid (Channel A) and 0.1% o-phosphoric acid in acetonitrile (Channel B). Mobile phase A was prepared by addition of 1.00 mL o-phosphoric acid to water in a 1-L volumetric flask, and adjusted to volume with water. Mobile phase B was prepared similarly with acetonitrile. The gradient program is tabulated in Table 1 with a constant flow rate of 1.0 mL/min, the column temperature maintained at 35° C., chromatograms were monitored at multiple wavelengths (quantification was at 330 nm only, cf. Wavelength Monitored), and injections were 5 μL. [0000] TABLE 1 HPLC elution program. Mobile phases Channel A 0.1% o-Phosphoric acid in water Channel B 0.1% o-Phosphoric acid in acetonitrile Column LiChrosorb RP-18 (250 × 4.6 mm, 5 μm, Supelco) with C18 guard (Supelco) Flow rate Gradient Time % B (mL/min) 0 28.0 1.0 7.00 40.6 7.20 100 8.20 100 8.30 28.0 10.00 28.0 Wavelength 330 nm Injection Vol. 5 μL Temperature 35° C. [0029] Preparation of Standard Solutions. To generate the calibration curve, a stock standard solution A with 1.502 mg/mL RA in 20 mM KH 2 PO 4 (pH 2.5): ethanol (1:1 v/v) was prepared. A series of working calibration solutions were made from the stock standard solution as listed in Table 2 to provide a range of concentrations from 0.0300 to 1.50 mg/mL RA. The working calibration solutions were assayed by HPLC using the method described in Table 2. The series standard solutions were injected in triplicate. The calibration curve was used to quantitate samples and standards in this study. [0000] TABLE 2 Preparation of working calibration solutions. Volume Standard Stock stock Final Final stock Stock solution added volume concentration solution level added (mL) (mL) (mg RA/mL) A 8 A 25 25 1.50 B 7 A 5 10 0.751 C 6 A 4 10 0.601 D 5 A 3 10 0.451 E 4 A 2 10 0.300 F 3 A 1 10 0.150 G 2 F 4 10 0.0601 H 1 F 2 10 0.0300 [0030] Wavelength selection. RA sample standard was run per the method, the absorption spectrum recorded and evaluated for the optimal wavelength to be monitored. [0031] Linearity of standards. The linearity of responses of standards at various levels was calculated based on the standard calibration data. A plot was generated using standard concentrations versus peak area responses, and to which the best-fit line was regressed without forcing through the origin. The concentration of RA ranged between 0.030 to 1.52 mg/mL. [0032] Precision of standards LC analysis. The precision of the standards analysis was determined by performing seven sequential injections of standard solution level 5, and the percent relative standard deviation was calculated based on the peak area response. [0033] Accuracy of standards injections. A level 4 standard was prepped and various injection volumes were analyzed and data regressed to the best-fit curve—linear data indicating correspondence with accuracy. Injection volumes ranged from 2.0 to 50 μl corresponding to RA masses of 0.61 to 15 μg, respectively. [0034] Precision of combined sample prep and LC analysis. The precision of the sample analysis was conducted using a composite (milled/homogenized) sample of plant tissue. Extracts were prepped as described, seven sequential injections were made, and the percent relative standard deviation was calculated for the peak area responses. [0035] Spike Recovery. An assessment of method accuracy was evaluated by spike recoveries. These were performed by preparing a stock solution of plant tissue extract with 0.343 mg RA/mL. Level 8 calibration standard stock solution was used to spike the spearmint extract solution at various levels. The two stock solutions were then mixed in varying proportions to cover the working range of RA (Table 3). Based on the assay results of the stock solution, the theoretical concentrations of the mixes were calculated and compared to the values obtained by the assay, and the percent differences between the theoretical and the observed concentrations were calculated. [0000] TABLE 3 Proportions used to make spiked solutions. Sample Standard Theoretical Volume Volume [RA] Sample (mL) (mL) (mg/mL) 1 1.40 0.10 0.422 2 1.30 0.20 0.500 3 1.20 0.30 0.577 4 1.00 0.50 0.733 5 0.50 0.50 0.928 [0036] Peak resolution. Analyte resolution was evaluated using RA and neighboring peaks derived from the precision experiment data of real-matrix samples. Resolution was calculated by using Equation 1, where R was the resolution, t # corresponded to the retention time of the peak, and w # was the width of the peak in time units. [0000] ( Resolution ) :  R = 2  ( t 2 - t 1 ) ( ω 2 + ω 1 ) Equation   1 [0037] Limits of Detection and Quantitation. The standard calibration curve data were used to calculate the limits of detection and of quantitation. The detection limit was calculated according to Equation 2. The quantitation limit was calculated according to Equation 3. In these equations, s is the slope of the calibration curve, and σ is the residual standard deviation of the regression line, σ=[(Σ(residuals2)/degrees of freedom] 1/2 , where the residuals are the difference of the observed and the best-fit values. [0000] (Limit of Detection): DL= 3.3 σ÷s.   Equation 2 [0000] (Limit of Quantitation): QL= 10 σ÷s   Equation 3 Results [0038] The initial moisture content of the fresh tissue tested using a moisture meter was approximately 87%. However, for the graphical representation of water loss over a period of time, the initial moisture levels were considered to be 100%. The moisture levels after each treatment was noted but the RA levels were not adjusted accordingly. The room temperature during the time of experiment was 22.2° C. and humidity was about 26%. The RA level for the 0 h time point (fresh tissue samples) for all drying methods was <2 mg/g. Since the estimated RA levels per unit sample weight in fresh tissue are diluted due to the high amounts of water present in them, these 0 h samples can bias the comparisons between drying time points. Therefore time point 0 h was not considered for the data analysis except for graphical representation. [0039] Dehydrator study: The dehydrator study was performed independently during the same week as that of the other drying methods. The analysis of variance, drying curves and the RA levels from the dehydrator study are presented below. [0040] (a) Analysis of variance: Significant variation was found for post-treatment weights and RA levels for both treatments (temperature and time) and treatment combinations (temperature×time) in this study (Table 4). [0000] TABLE 4 Mean squares and P values for post-treatment weights and RA levels for samples dried using dehydrator. Post drying weights RA levels Deg. of Mean Mean Source freedom squares P value squares P value Rep 2 0.01334 0.1362 73.037 0.0564 Temp 3 0.2269 <0.0001 2651.54 <0.0001 Time 3 0.1099 <0.0001 233.01 <0.0001 Temp*Time 9 0.0665 <0.0001 329.54 <0.0001 R2 0.897 0.841 CV % 12.95 27.24 [0041] The means and LSDs of different temperatures are given in Table 5. Among different durations of drying, 24 h of drying was significantly different from other durations for post-treatment weights. RA levels were significantly lower in 24 h drying period and higher in 96 h drying period compared to all time points. Among different temperatures, post-treatment weight was significantly higher at RT while RA levels were significantly lower at 57° C. (Table 5). [0042] The means and LSD of different temperature×time combinations are given in Table 6. Among different treatment combinations, drying at RT for 24 h and 48 h had significantly higher post drying tissue weights while drying at 57° C. for 96 h had resulted in significantly lower tissue weights (Table 6). There were no significant differences among post-drying weights for tissue dried at 35° C. or 41° C. for any number of hours of drying. For RA levels, drying at RT for 24 h and at 57° C. for 24 h, 48 h, 72 h and 96 h all resulted in significantly low amounts of RA retention in tissues compared to other temperatures. Drying tissues at RT for 72 h and 96 h resulted in significantly higher levels of RA retention compared to other temperatures. No significant differences among RA levels were observed for tissue dried at 35° C. or 41° C. for any duration of drying (Table 5). [0000] TABLE 5 Means and LSD of treatements( temperature and time) RA levels in post- Post-treatment treatment samples Treatment weights (g)† (mg/g) † Time of 24 h 0.675a 17.36a drying 48 h 0.580b 20.84ab 72 h 0.565b 21.98ab 96 h 0.564b 23.14c LSD 0.151 4.82 Temperature RT 0.813a 26.94a 35° 0.565b 25.62a 41° 0.558b 26.43a 57° 0.507b 4.62b LSD 0.133 4.71 † Means with different letters are significantly different from each other [0000] TABLE 6 Means and LSD of treatement (temperature × time) combinations. Treatment Post-treatment RA levels in post-treatment combination weights (g) † samples (mg/g) † RT_24 h 1.273a 1.25a RT_48 h 0.747b 29.07bcd RT_72 h 0.640bcd 35.19d RT_96 h 0.593cde 33.67cd 35°_24 h 0.657bc 26.39b 35°_48 h 0.543cde 27.06bc 35°_72 h 0.533cde 24.66b 35°_96 h 0.527cde 24.40b 41°_24 h 0.540cde 29.58bcd 41°_48 h 0.557cde 22.95b 41°_72 h 0.553cde 24.48b 41°_96 h 0.583cde 28.73bcd 57°_24 h 0.543cde 4.92a 57°_48 h 0.470e 4.22a 57°_72 h 0.510de 3.58a 57°_96 h 0.503e 5.77a LSD 0.136 6.87 † Means with different letters are significantly different from each other [0043] (b) Drying curve: The variation of post-treatment weight of the tissue as a function of time was followed. Plots of the relative moisture content as a function of time and rate of drying are shown in FIG. 1 . Thus an experimental curve representing the drying characteristics of spearmint tissue was obtained. The post-treatment weights of spearmint tissue in relation to drying time are presented in FIG. 1 a and the changes in relative water content as a function of drying time is given in FIG. 1 b . The relative water content dropped from 100% to 15% at RT in 48 hours and then gradually reached 10% level in 96 h. On the other hand while drying at 35° C., the relative water content dropped to 13% at 24 h and reached 10% after 48 h and remained constant for the rest of the time. However, at 41° C. and 57° C. the relative water content rapidly dropped to 10% within 24 h of drying and remained constant for the rest of the drying durations. [0044] The time taken to reach a moisture content of about 10% at RT was about 48 h, while it took only about 24 h using a dehydrator set at 35° C., 41° C. and 57° C. The moisture content remained at a constant level of 10% whether dried at RT, 35° C., 41° C. or 57° C. after 48 h ( FIGS. 1 a and 1 b ). [0045] (c) RA levels: The effect of temperature and duration of drying on RA content of spearmint tissue dried using dehydrator is given in FIG. 2 . The highest level of RA was retained when the tissue was dried at RT for 48 h-72 h after which the RA levels gradually started to decrease. The RA levels of tissue dried at 35° C. and 41° C. remained at a relatively constant level while dried for 48 h, 72 h and 96 h. However the tissue dried at 57° C. lost most of the RA content (about 80% lost) when dried for 24 h or greater. [0046] Microwave study: The microwave study was performed independently during the same week as that of the other drying methods study. The analysis of variance, drying curves and the RA levels from the microwave study are presented below. [0047] (a) Analysis of variance: The analysis of variance showed significant variation for post-treatment weights and RA levels for eight different durations of microwave drying in this study (Table 7). [0000] TABLE 7 Mean squares and P values for post-treatment weights and RA levels for samples dried using microwave. Post-treatment weights RA levels Mean Mean Source df squares P value squares P value Rep 2 0.0276 0.4702 64.42 0.6889 Time 7 0.406 <0.001 2901.65 <.0001 R2 0.857 0.849 CV % 20.30 19.48 [0048] The means and LSD for the duration of drying are given in Table 8. Among different durations of drying, 0.5 min of drying was significantly different from all other durations and 1 minute of drying was significantly different from ≧2.5 minutes of drying for post-treatment weight. RA levels were significantly lower in 0.5 min and 4 min microwave drying and significantly higher for the rest of the time points. Among all time points, 2.5 minutes of drying seem to retain the highest amount of RA with minimal tissue shrinkage (Table 8). [0000] TABLE 8 Means and LSD for post treatement weights and RA levels for microwave study RA levels in post- Duration of Post-treatment treatment samples drying weights (g)† (mg/g)† 0.5 1.720a 13.54a 1 1.167b 34.38b 1.5 0.900bc 58.69c 2 0.797bc 67.80cd 2.5 0.793c 74.59d 3 0.697c 68.43cd 3.5 0.677c 67.59cd 4 0.603c 35.25b LSD 0.326 11.99 †Means with different letters are significantly different from each other [0049] (b) Drying curve and RA levels: The relative water content and RA levels versus duration of drying curves for microwave drying at 70% microwave output power of spearmint tissue is shown in FIG. 3 . A rapid decrease in moisture content in the tissue was observed wherein the moisture levels dropped from 100% to 30% in 30 seconds. The microwave drying process reduced the spearmint tissue moisture content to approximately 15% in 2.5 minutes. As the duration of drying increased from 2.5 min up to 4 minutes there was no further significant reduction in moisture levels in the tissue. The highest level of RA was observed at 2.5 minutes of microwave drying which was significantly higher than all other durations tested. The RA levels gradually increased with an increase in duration of drying up to 2.5 minutes and then gradually decreased with the increase in time. [0050] Freeze-dryer study: The freeze dryer study was performed independently during the following week of the dehydrator and microwave study. The analysis of variance, drying curves and the RA levels from the freeze-dryer study are presented below. [0051] (a) Analysis of variance: The analysis of variance showed no significant variation for both post-treatment weights and RA levels for four different durations of freeze-drying (Table 9). [0000] TABLE 9 Mean squares and P values for post-treatment weights and RA levels in freeze-dryer study. Post-treatment weights RA levels Mean Mean Source df squares P value squares P value Rep 2 0.0225 0.2667 160.40 1.79 Time 3 0.0567 0.0643 188.132 0.2335 R2 0.865 0.878 CV % 20.1 16.71 [0052] The means and LSD for the duration of drying are given in Table 10. Among different durations of drying, 24 h of drying was significantly different from all other time points for post-treatment weights. However the RA levels did not vary for different durations of freeze-drying. Among all time points, 24 h of freeze drying seem to retain the highest amount of RA with the lowest amount of tissue shrinkage (Table 10). [0000] TABLE 10 Means and LSD for post treatement weights and RA levels for freeze-dryer study Duration of Post-drying RA levels drying weights (g)† (mg/g)† 24 h 1.026a 79.89a 48 h 0.760b 63.16a 72 h 0.757b 64.86a 96 h 0.740b 64.36a LSD 0.233 19.50 †Means with different letters are significantly different from each other [0053] (b) Drying curve and RA levels: The relative water content and RA levels versus duration of drying curves for freeze drying of spearmint tissue is shown in FIG. 4 . A rapid decrease in moisture content in the tissue was observed where the moisture levels dropped from 100% to 20% in 24 h of freeze drying and remained at a constant of <15% for further time points. There was no significant change in RA levels irrespective of duration of drying. Discussion [0054] Spearmint is a highly seasonal and perishable plant with high levels of moisture content. KI-MsEM0028 had initial moisture content of 87±0.5%, which indicates that 870 kg water have to be evaporated per 1000 kg of fresh mint leaves before extraction. [0055] The results from the dehydrator study suggested that the temperature at which the tissue was dried and the duration of drying played a significant role in rapid loss of moisture and retention of the RA levels. Results showed that drying took place rapidly during the first 48 hours of drying treatment where the moisture levels dropped from 100% to less than 20%. This was followed by a relatively constant drying period where the relative water content lowered from approximately 15% to 10% at RT and remained constant at about 10% for the other temperatures. However, the RA levels seem to be retained at the highest level after drying at RT for 48 h to 72 h. Although a faster process, drying tissues at temperatures higher than RT using a dehydrator reduced the RA levels below 30 mg/g. The RA levels when dried at 35° C. or 41° C. remained constant after drying for 48 h or greater. However, when the tissue samples were dried at higher temperature (≧57° C.) the RA levels were reduced by up to 80% within 24 h of drying. The length of time required to dry the leaf tissue using a conventional drying approach would be too long for commercial utility. Furthermore, as RA level and stability is highly temperature sensitive, drying would be limited to temperatures below 41° C. [0056] In microwave drying, different durations starting from 30 sec to 4 minutes were used for drying the tissue. A maximum of 4 minutes drying was adopted beyond which browning of tissue became an issue. There was a rapid reduction in moisture levels to a 30% moisture level within 30 sec of drying at 70% output power. The optimum drying time for maintaining highest RA levels without much tissue shrinkage was about 2.5 minutes wherein the moisture levels were about 10%. [0057] Freeze drying retained the highest levels of RA after 24 h of drying with the lowest amount of tissue shrinkage observed. A rapid reduction in moisture level was observed at 24 h of drying after which the moisture levels remained at a constant level. However, continuous freeze-drying of tissue beyond an optimum level of 24 h did not significantly reduce the RA levels as observed with the dehydrator and microwave methods. [0058] In comparing all three methods, the microwave method dried the tissue faster without significant reduction in the RA levels, leaf color and tissue shrinkage. Although freeze drying seems to be the most efficient in terms of retention of RA levels, it requires much more capital investment and time for drying which limits its utility at a commercial scale. In summary, microwave drying is a surprisingly effective method for drying the spearmint biomass while maintaining optimum RA levels for extraction. Example 2 [0059] Approximately 2.5 acres each of the 2 proprietary rosmarinic acid (RA) hyper-accumulator spearmint clonal lines (KI-MsEM0110 and KI-MsEM0042) were grown at two field locations. A pilot scale microwave dryer was assembled and transported to the fields for drying of the spearmint plant material shortly after harvesting. The microwave dryer system included two 75 kilowatt transmitters with wave guides two oven units which included variable speed top and bottom conveyor belts to hold the spearmint leaf and stem tissue as it passed through the ovens (AMTek, Cedar Rapids, Iowa). [0060] Spearmint leaf and stem tissue was harvested in the field using a windrower (John Deere 3430 ) and manually lifted into a wagon for transportation to the microwave dryer system, situated in a farm building. Belt load, energy level and belt speed were varied until leaf and stem tissue reached a moisture level <10% and arcing occurrence was minimized. [0061] Composite samples of leaf and stem tissue were also taken at the same time for drying in a small household microwave oven for comparison purposes. Three replicate samples of each composite were tested for RA content using the described in Example 1. Samples of whole leaf and chopped leaf were taken for a comparison of RA stability over time post-harvest. [0062] Preferred settings for KI-MsEM0110 were an energy level of 63 KW in oven 1 ; 15 KW in oven 2 ; and a belt speed of 40″/minute to achieve a consistently dry product <10% moisture. The power used to remove each pound of water at the preferred settings was 0.392 kwh/lb (40,671 BTU/30 lbs=1,356 BTU/lb/3412.3 kw/BTU). [0063] Rosmarinic acid levels ranged from approximately 5.0% to >7.0% on a dry matter basis which was favorable considering that harvest and drying occurred post flowering. These levels would be expected to be >9.0% when harvested pre-flowering. There were no significant differences in rosmarinic acid levels between the control microwave-dried tissue and the tissue dried in the larger scale pilot microwave system. It is important that whole leaf tissue be harvested as a rapid loss of rosmarinic acid was observed in chopped leaf tissue compared to whole leaf tissue. [0064] The foregoing description and drawings comprise illustrative embodiments of the present inventions. The foregoing embodiments and the methods described herein may vary based on the ability, experience, and preference of those skilled in the art. Merely listing the steps of the method in a certain order does not constitute any limitation on the order of the steps of the method. The foregoing description and drawings merely explain and illustrate the invention, and the invention is not limited thereto, except insofar as the claims are so limited. Those skilled in the art who have the disclosure before them will be able to make modifications and variations therein without departing from the scope of the invention.

1a

The present patent application is a continuation of U.S. patent application Ser. No. 12/091,939 filed Apr. 29, 2008, which claims priority of International Patent Application PCT/US2006/042939 filed Nov. 3, 2006, which claims priority of U.S. Provisional Patent Application No. 60/734,605, filed Nov. 7, 2005, the contents of which are incorporated in their entirety. This invention relates to personal cooling, compression, and grounding. In particular, the invention relates to increasing vascular performance of humans by lowering the core body temperature, compression of the blood vessels, and grounding of the body. The background art is characterized by U.S. Pat. Nos. 620,679; 3,211,153; 3,317,650; 3,596,134; 3,596,134; 3,744,555; 4,149,529; 5,092,317; 5,571,075; 6,109,338; 6,149,618; 6,683,779; 6,757,916; and 7,089,995 and U.S. Patent Application Nos. 2004/0167594; 2004/0267168; 2005/0094348; and 2006/0122544; the disclosures of which patents and patent applications are incorporated by reference as if fully set forth herein. BACKGROUND OF THE INVENTION Restriction of blood flow by applying compression has been shown to speed up muscle growth and muscle strength. The invention of U.S. Pat. No. 6,149,618 is limited, however, in that applying too much compression to the circumference of an extremity of a human body can be dangerous, because an embolism can result. Under these conditions, a blood clot can form, break off, and become lodged in the brain or heart. Moreover, in the absence of precisely controlled core body cooling, reducing the rate at which blood circulates in an extremity can produce an unbearable amount of pain for most people. The background art is also characterized by the products of Life Enhancement Technologies, Inc. (LET). LET has developed and patented a line of personal cooling products for medical, military, industrial, and consumer applications. One of these products is Flexitherm™, a proprietary liquid heat transfer system made of a thin, flexible, conductive material, which transports fluid to provide direct conductive cooling. LET products embody technologies disclosed in U.S. Pat. Nos. 4,138,743; 4,691,762; 4,884,304; 5,033,136, and 6,551,347, the disclosure of which patents are incorporated by reference as if fully set forth herein. The background art is also characterized by published articles. Relevant articles include Ober, C. “Grounding the human body to neutralize bioelectrical stress from static electricity and EMFs”, EDS Journal; Becker, R. O., “Body Electric”; Becker R. O., “Cross Currents”, and Metz, C. et al, “Moderate hypothermia in patients with severe head injury: cerebral and extracerebral effects”, comment in J. Neurosurg. 1997, May, 85(5):911-914. What is needed is an apparatus and method for increasing vascular performance of humans by simultaneously lowering core body temperature, compression of blood vessels, and grounding of the body in a controlled way. BRIEF SUMMARY OF THE INVENTION One purpose of the invention is to prevent heat stress and perspiration during exercise. Another purpose of the invention is to increase human growth hormone release. Yet another purpose of the invention is to allow the body to maintain its natural bio/electric flow. Yet another purpose of the invention is use in emergency medical (ambulance) applications for treatment of spine and head injuries. Electrical grounding of the human body results in significant benefits in restoring the bio/electrical levels to their natural state. One purpose of the invention is to facilitate electrical grounding of the human body with smart spheres, which in a preferred embodiment are multi-functional, thin, compliant metallic devices which also channel a coolant liquid and measure pulse and body temperature. Another purpose of the invention is to precisely control the pressure applied to the blood vessels of the extremities, thus safely restricting the blood flow which will result in higher amounts of growth hormone being released into the body. Growth hormone release has many restorative properties, such as balancing the body's hormonal function, burning excess fat and optimizing the metabolic rate. High levels of growth hormone also contribute to the formation of additional collateral circulation, thus vascular performance is significantly increased. In a preferred embodiment of the invention, the pressure that is applied to the body is in the range 178 millimeters mercury (mm Hg) to 238 mm Hg and is applied at relatively short intervals. Preferably, pressure settings are controlled by automatic fluidic valves with a manual override to ensure that a safe and correct pressure is applied to the human body. Another purpose of the invention is to precisely control the applied pressure in order to prevent tissue damage. In a preferred embodiment, the apparatus measures the blood pressure prior to each use of the apparatus and ensures that the maximum pressure does not exceed 122 percent of the systolic blood pressure. Preferably, smart spheres placed on the distal extremities of the body of the user measures the distal extremity pulse every about 33 seconds during a use protocol and reports the pulse values to a control unit. If the pulse becomes too weak, the control unit reduces the amount of pressure applied to the user's body. Another purpose of the invention is to facilitate treatment of geriatric and pediatric patients using an apparatus that comprises smart spheres to ensure comfortable and multi-functional control. One advantage of preferred embodiments of the invention is that core cooling during exercise prevents heat stress and perspiration. Evaporation of perspiration is the only natural way the body can lower its core temperature through the skin. In order to achieve perspiration, as much as forty percent of the blood flow is shunted from the muscle tissue to the skin surface which results in much lower blood flow in the muscles. This causes decreased elimination of lactic acid from the muscles and decreased delivery of oxygenated blood to the muscles, resulting in increased pain and discomfort associated with rigorous exercise. With preferred embodiments of the invention, there is no need for the body to sweat during exercise, thus the active muscles maintain full blood flow levels, lactic acid is removed at much more rapid pace, the delivery of oxygenated blood to the muscles is maintained at optimum levels, resulting in the exercise experience being free of discomfort and pain, with immediate post exercise recovery. Another advantage of preferred embodiments of the invention is to increase blood density through the application of specific core body cooling gradients. Thus, the amount of pressure to the blood vessels during exercise can be reduced when compared to background art methods, to facilitate a desired growth hormone release. With preferred embodiments of the invention, the amount of pressure applied to the blood vessels is controlled in order to avoid complete occlusion of the vessels. Core body cooling, preferably utilizing the precisely applied and temperature regulated spheres, results in increased density of the blood, thus the amount of pressure applied to the blood vessels is decreased, avoiding the dangers associated with complete occlusion of the blood vessels. Yet another advantage of preferred embodiments of the invention is that applying pressure to the blood vessels during exercise, along with cooling and grounding, significantly lowers or eliminates the risks. Core body cooling and grounding with vascular pressure during exercise maintains the normal body bio/electric flow patterns, by preventing perspiration and by releasing the static electrical charge to the ground. The subject performing the exercise protocol is therefore clear headed and not in a stress situation. Another advantage of preferred embodiments of the invention is that electrical grounding during exercise, along with core body cooling and applied vascular pressure provides the electrical channel for the release of static electrical charge from the body, as well as delivery to the body of the Earth's neutral electrons. The human body was designed to be in direct contact with the ground. Electrical grounding allows the body to maintain its natural bio/electric flow and thus its physiologic functions are maintained at the optimal levels. In a preferred embodiment, the invention is an apparatus and method for increasing vascular performance of humans by lowering core body temperature, compression of blood vessels, and grounding of the body. Preferably, the invention comprises grounded pressure cooling of a portion or all of the human body. In another preferred embodiment, the invention is an apparatus for treating an exercising human body, said apparatus comprising means for lowering the core body temperature, means for compressing the body's blood vessels, and means for grounding the body. In a preferred embodiment, the invention is a method for treating an exercising human body, said method comprising lowering the core body temperature, compressing the body's blood vessels, and grounding the body. In use, the invention is operated by applying means for absorbing heat and exerting controlled pressure to the limbs of a human subject; electrically connecting the human subject to the ground; and causing the human subject to exercise. In a preferred embodiment, the invention is an apparatus that comprises: a compression/cooling garment for installation on a human body, and a core body cooling and grounding unit, said core body cooling and grounding unit comprising a display having a user interface and a processor that is operated in accordance with a software program. Preferably, said compression garment comprises cooling spheres. Preferably, said cooling and grounding unit comprises a compressor and a condenser and an umbilical cord that connects said compression garment to said compressor and said condenser. In a preferred embodiment, the invention is a method for increasing vascular performance of a human body by lowering core body temperature, compression of blood vessels, and grounding of the body. Preferably, the method comprises using a coolant that is in a temperature range from about 44 degrees F. to about 56 degrees F. (measured as it is leaving the chiller within core body cooling and grounding unit 14 ) to lower the core body temperature is lowered by about 2 or 3 degrees F. to about 96 F as stated below. In a preferred embodiment, the method also comprises compressing the blood vessels of the body's upper arms and legs by applying a pressure in the range from about 178 mm Hg to about 238 mm Hg to the exterior of the upper arms and legs, and by grounding the body to the earth. Preferably, a core body temperature of about 96 degrees F. is achieved. Preferably, a pressure of about 238 mm Hg pressure (maximum) is applied for up to about six minutes, but the applied pressure may vary with the initial measured systolic blood pressure of the user. In a preferred embodiment, the invention is an apparatus that comprises: a compression/cooling garment for installation on a human body, said compression/cooling garment comprising the following components: two upper arm bladder assemblies, each upper arm bladder assembly comprising an upper arm air bladder and an upper arm fluidic bladder (preferably filled with a circulating liquid coolant at a precisely controlled temperature gradient), two upper thigh bladder assemblies, each upper thigh bladder assembly comprising an upper arm air bladder and an upper arm fluidic bladder, two arm sensor holders, each arm sensor holder supporting an arm sensor, and two leg sensor holders, each leg sensor holder supporting a leg sensor; a cooling and grounding unit, said cooling and grounding unit comprising a display having a user interface and a processor that is operated in accordance with a software program and said cooling and grounding unit being electrically connectable to a ground; and an umbilical cable that operably connects said components of said compression/cooling garment to said cooling and grounding unit. Preferably, said compression/cooling garment further comprises a suit comprising a first plurality of smart spheres, a left foot piece comprising a second plurality of smart spheres, a right foot piece comprising a third plurality of smart spheres and a head piece comprising a fourth plurality of smart spheres; each of said smart spheres comprises a heat exchanger that provides a circuitous path for coolant introduced to it; and each of said heat exchangers is a part of a separated cooling circuit that is connected to said cooling and grounding unit. Preferably, each arm sensor is capable of measuring a wrist pulse and each leg sensor is capable of measuring ankle pulse. Preferably, each of said smart spheres further comprises a grounding contact, a pulse sensor and a temperature sensor; each grounding contact is connected to said cooling and grounding unit by a grounding lead and is operative to ground said human body; each said pulse sensor is operative to send a pulse signal to cooling and grounding unit; and each said temperature sensor is operative to send a temperature signal to cooling and grounding unit. In a preferred embodiment, at least a portion of said first plurality of smart spheres is located in a part of said suit that is disposed adjacent to the spine of said human body when said apparatus is in use. Preferably, each of said air bladders is in air pressure communication with said cooling and grounding unit and each of said fluidic bladders is in fluidic communication with said cooling and grounding unit. Preferably, said cooling and grounding unit comprises a compressor and a condenser and said umbilical cord connects said compression garment to said compressor and to said condenser. Preferably, each arm sensor comprises a clip-on finger pulse sensor and each leg sensor comprises a clip-on toe pulse sensor. In another preferred embodiment, the invention is an apparatus for treating an exercising human body, said exercising human body having a core body temperature and limbs having blood vessels, said apparatus comprising: means for lowering the core body temperature of the exercising human body; means for compressing the blood vessels of the exercising human body; and means for grounding the exercising human body. In yet another preferred embodiment, the invention is a method for increasing the vascular performance during an exercise protocol of a human body having extremities, said method comprising: measuring an initial systolic blood pressure and an initial pulse in each extremity of the human body; measuring the core body temperature of the human body; lowering the core body temperature of the human body to about 96 degrees Fahrenheit; establishing a target blood pressure in each extremity of the human body by applying a pressure in the range from about 178 mm Hg to about 238 mm Hg to each extremity with a band that is disposed around each extremity, said target blood pressure being approximately 120 percent of the initial systolic blood pressure in each extremity; establishing a target pulse each extremity of the human body, said target pulse being detectable during the exercise protocol; and grounding the human body. In a further preferred embodiment, the invention is a method for increasing vascular performance of a human body said human body having a core body temperature and upper arms and upper thighs having blood vessels, said method comprising: a step for lowering the core body temperature of the human body; a step for compressing the blood vessels of the upper arms and the upper thighs of the human body; and a step for grounding of the human body. Preferably, the method further comprises: using a coolant that is in a temperature range from about 44 degrees Fahrenheit to about 56 degrees Fahrenheit to lower the core body temperature by about 2 or 3 degrees Fahrenheit to about 96 Fahrenheit. Preferably, the method further comprises: compressing the blood vessels of the body's upper arms and upper thighs by applying a pressure in the range from about 178 mm Hg to about 238 mm Hg to the exterior of the upper arms and upper thighs of the body. Preferably, the method further comprises: lowering the core body temperature to about 96 degrees Fahrenheit. Preferably, the method further comprises: applying a maximum pressure of about 238 mm Hg to the upper arms and upper thighs for up to about six minutes. In yet another preferred embodiment, the invention is a method for increasing the amount of growth hormone produced by a subject having limbs, said method comprising: the subject's donning a compression garment; connecting said compression garment to a core body cooling and grounding unit; measuring an initial blood pressure and an initial pulse rate in each of the limbs of the subject and confirming that the subject is grounded; commencing an exercise regime; circulating a coolant through said compression garment to produce a subsequent body temperature; and compressing a portion of each limb of the subject while monitoring a subsequent pulse and a subsequent blood pressure in each limb and said subsequent body temperature. Preferably, the method further comprises: controlling said subsequent blood pressure in each limb by applying a pressure in the range from about 178 mm Hg to about 238 mm Hg to the exterior of an upper portion of the limbs of the subject. Preferably, the method further comprises: lowering the body temperature of the subject by about 2 or 3 degrees Fahrenheit. Preferably, the method further comprising: lowering the body temperature of the subject to about 96 Fahrenheit. In another preferred embodiment, the invention is a method of minimizing swelling after injury of a subject, said method comprising: placing the subject on a stretcher that incorporated smart spheres that are imbedded in memory foam; and lowering the temperature of the head, neck and spine of the subject by about 2 or 3 degrees Fahrenheit by circulating a coolant through said smart spheres; wherein each of said smart spheres comprises a heat exchanger that provides a circuitous path for coolant introduced to it; and wherein each of said heat exchangers is a part of a separate cooling circuit that is connected to a cooling and grounding unit. In another preferred embodiment, the invention is an apparatus for enveloping and immobilizing an injured person, said apparatus comprising: an inflatable compression garment comprising two flaps that are attachable to one another by a zipper or belts and individual temperature control units; and a cooling unit comprising a compressor and a condenser; wherein each of said individual temperature control units comprises a heat exchanger that provides a circuitous path for coolant introduced to it; and wherein each of said heat exchangers is a part of a separated cooling circuit that is connected to said cooling and grounding unit. In yet another preferred embodiment, the invention is an apparatus for increasing driving comfort of a user, said apparatus comprising: a vehicle seat for supporting the user that comprises an integral seat bottom heat exchanger and an integral seat back heat exchanger; a safety belt for securing the user in said seat that comprises an integral safety belt heat exchanger; a pair of inflatable upper arm fluidic bladders for encircling the upper arms of the user; a pair of inflatable upper thigh fluidic bladders for encircling the upper thighs of the user; means for measuring the initial systolic blood pressure of the user; and means for cyclically inflating said pair of inflatable upper arm fluidic bladders and said pair of upper thigh fluidic bladders to a inflation pressure that is approximately thirty percent greater than said initial systolic blood pressure at a cyclic inflation frequency that is in the range from about thirty times per minute to about sixty times per minute. In a further preferred embodiment, the invention is a method for increasing driving comfort of a user, said method comprising: supporting the user in a vehicle seat that comprises an integral seat bottom heat exchanger and an integral seat back heat exchanger; securing the user in said seat with a safety belt that comprises an integral safety belt heat exchanger; encircling each of the upper arms of the user with an inflatable upper arm fluidic bladder; encircling each of the upper thighs of the user with an inflatable upper thigh fluidic bladder; measuring the initial systolic blood pressure of the user; and cyclically inflating said pair of inflatable upper arm fluidic bladders and said pair of upper thigh fluidic bladders to a inflation pressure that is approximately thirty percent greater than said initial systolic blood pressure at an inflation frequency that is in the range from about thirty times per minute to about sixty times per minute. In another preferred embodiment, the invention is a method for increasing the performance of a swimmer, said method comprising: encircling each of the upper arms of the swimmer with an inflatable upper arm fluidic bladder; encircling each of the upper thighs of the swimmer with an inflatable upper thigh fluidic bladder; measuring the initial systolic blood pressure of the user; and cyclically inflating said pair of inflatable upper arm fluidic bladders and said pair of upper thigh fluidic bladders to an inflation pressure that is approximately thirty percent greater than said initial systolic blood pressure at an inflation frequency that is in the range from about thirty times per minute to about sixty times per minute. Further aspects of the invention will become apparent from consideration of the drawings and the ensuing description of preferred embodiments of the invention. A person skilled in the art will realize that other embodiments of the invention are possible and that the details of the invention can be modified in a number of respects, all without departing from the concept. Thus, the following drawings and description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE SEVERAL VIEW OF THE DRAWINGS The features of the invention will be better understood by reference to the accompanying drawings which illustrate presently preferred embodiments of the invention. In the drawings: FIG. 1 is a perspective view of a preferred embodiment of the invention, shown in use. FIG. 2 is a perspective view of a foot piece of a preferred embodiment of the invention. FIG. 3 is a bottom plan view of a foot piece of a preferred embodiment, of the invention. FIG. 4 is a front elevation view of the compression garment in a preferred embodiment of the invention. FIG. 5 is a back elevation view of the compression garment in a preferred embodiment of the invention. FIG. 6 is another front elevation view of the compression garment in a preferred embodiment of the invention. FIG. 7 is a perspective view of the head piece of a preferred embodiment of the invention. FIG. 8 is a top plan view of a smart sphere of a preferred embodiment of the invention. FIG. 9 is a cross sectional view of a smart sphere of a preferred embodiment of the invention, at the section indicated on FIG. 8 . FIG. 10 is another cross sectional view of a smart sphere of a preferred embodiment of the invention, at the section indicated on FIG. 8 . FIG. 11 is a perspective view of a bladder assembly of a preferred embodiment of the invention. FIG. 12 is a cross sectional view of a bladder assembly of a preferred embodiment of the invention, at the section indicated on FIG. 11 . FIG. 13 is another cross sectional view of a bladder assembly of a preferred embodiment of the invention, at the section indicated on FIG. 11 . FIG. 14 is a side elevation view of another preferred embodiment of the invention. FIG. 15 is a side elevation view of yet another preferred embodiment of the invention. FIG. 16 is a front elevation view of the preferred embodiment of the invention illustrated in FIG. 15 . The following reference numerals are used to indicate the parts and environment of the invention on the drawings: 10 apparatus 12 compression wear, compression garment, compression/cooling garment 14 cooling and grounding unit 15 umbilical cable 16 display 18 body 20 rod 22 conductor 24 exercise machine 25 suit 26 foot pieces 28 hat piece 30 smart spheres, individual cooling units 32 foot covering 34 sole 36 inlet tubes 38 outlet tubes 42 air bladder 44 fluidic bladder 46 sensor holders, bands 50 sensors 51 tubing bundles 52 longitudinal zippers 54 circuitous path 58 leads 60 bladder assembly 62 fluidic bladder tubing 64 air bladder tubing 66 gurney, patient transport unit 80 vehicle seat 82 integral seat heat exchangers 84 safety belt heat exchanger 86 safety belt DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1 , a preferred embodiment of system 10 is illustrated. In this embodiment, apparatus 10 comprises: compression garment 12 and cooling and grounding unit 14 comprising display 16 having a user interface and a processor (not shown) that is operated in accordance with a software program that is resident in a memory unit (not shown). Compression garment 12 is connected to cooling and grounding unit 14 by umbilical cable 15 . Treatment of body 18 of a human subject serves to maximize human performance and minimize rehabilitation time. In a preferred embodiment, cooling and grounding unit 14 is grounded by being connected to grounded rod 20 by conductor 22 . In use during exercise on exercise machine 24 , apparatus 10 accomplishes cooling, vascular restriction (compression) and electron transfer (grounding) of body 18 with significant rehabilitative, fitness and restorative benefits. In a preferred embodiment, compression wear 12 comprises one suit 25 , two foot pieces 26 and one hat piece 28 . Pain, muscle spasms, tissue damage and swelling are reduced by specific changes to the core body temperature by apparatus 10 . Core cooling of body 18 with apparatus 10 also allows for significantly more efficient vascular restriction during exercise that is proven to increase the natural secretion of growth hormones by body 16 . Referring to FIG. 2 , one of the foot pieces 26 is illustrated. Foot covering 26 comprises a plurality of smart spheres that are mounted in foot covering 32 . Zipper 34 provided a means to open foot covering 32 . FIG. 3 presents a bottom view of one of the foot pieces 26 in accordance with a preferred embodiment of the invention. In this view, the smart spheres 30 are shown mounted in sole 34 . Smart spheres are preferably not spherical in shape, but rather are substantially hollow bladders. As is the case with all preferred smart spheres 30 , these smart spheres 30 have a lower surface (not shown) that is disposed adjacent to the surface of body 18 when in use. Preferably, each smart sphere is connected to cooling and grounding unit 14 by inlet tube 36 and outlet tube 38 . Coolant (not shown) flowing in inlet tube 36 enters one of the smart spheres 30 , circulates through a preferably circuitous path within the smart sphere 30 and then exits through outlet tube 38 . In a preferred embodiment, the rate of flow of coolant circulating through each of the smart spheres 30 or each of the group of smart spheres 30 in suit 25 , hat piece 28 and each of the foot pieces 26 is individually controlled by means of cooling and grounding unit 14 . Referring to FIG. 4 , a front view shows compression garment 12 installed on body 18 . Suit 25 of compression garment preferably comprises a plurality of smart spheres 30 (indicated with dashed lines), four air bladders 42 (indicated with solid lines), four fluidic bladders 44 (indicated with a first pattern), four sensor holders or bands 46 (indicated with a second pattern) and four sensors 50 (two of which are shown as solid dots, the others being located in the ankle bands). Referring to FIG. 5 , a back view shows compression garment 12 installed on body 18 . Suit 25 of compression garment preferably comprises a plurality of smart spheres 30 (shown in dashed lines) that are located along the spine of body 18 . Tubing bundles 51 are shown to connect the components of compression garment 12 . By locating a series of smart spheres 30 along the spine of body 18 , an effective amount of cooling of the cerebral spinal fluid is achieved using coolant that is maintained at a lower temperature than would otherwise be used. In a preferred embodiment, the shapes of the smart spheres 30 disposed along the spine are configured to match the contour of body 18 and maximize heat transfer by conduction. In the case of use of apparatus 10 to treat a spinal injury, cooling of the injured area can lower the metabolic rate (in that not as much blood is needed to supply spinal tissues). This technique can be used to reduce the ordinarily massive amount of lymphatic fluid that is directed by body 18 to the injured area. This in turn can reduce swelling and allow new connections among spinal tissues to be established after injury to the spine. Similarly, use of apparatus 10 can reduce the increase in pressure on the brain that often results from a skull injury, pressure that can reduce the amount of blood that reaches the brain, in some cases causing brain death. Thus, a reduction in swelling (due to mild hypothermia and other effects produced by use of apparatus 10 ) can save spinal cord and brain function. In an alternative embodiment, compression garment 12 is configured to allow cooling of the head, neck and spine of body 18 , lowering the metabolic rate of those body parts and minimizing swelling after injury. In another alternative embodiment, smart spheres 30 that are embedded in memory foam are incorporated into a stretcher and located adjacent to the spine and neck and surrounding the head of the injured person being transported in the stretcher. In another alternative embodiment, an inflatable version of compression garment 12 is used to envelope and immobilize an injured person. In this embodiment, compression garment 12 comprises two washable flaps that are held together by a zipper or belts. The pressure on body 18 exerted by inflating compression garment 12 has the effect of minimizing bleeding. In such mobile embodiments, grounding of body 18 may not be provided for or accomplished. In another alternative embodiment, apparatus 10 comprises a plurality of core body cooling spheres 30 that are built into an automobile seat. Conduction core cooling of body 18 occurs when it was seated in the seat, thus eliminating the need for air conditioning. Referring to FIG. 6 , a preferred embodiment of compression garment 12 is installed on body 18 . In this embodiment, access to suit 25 is shown to be by means of two longitudinal zippers 52 . In this embodiment, compression garment 18 covers essentially all of body 18 except the hands and face. In an alternative embodiment, compression garment 12 covers only the torso and head of body 18 . The pair of fluidic bladders 44 that encircle the upper legs of body 18 preferably have two ends that are joined either by means of longitudinal zippers 52 or more preferably by separate clasps (not shown) or Velcro@ fasteners (not shown). The pair of air bladders 42 that encircle the upper legs of body 18 also have two ends that are preferably joined by separate clasps (not shown) or Velcro@ fasteners (not shown). Referring to FIG. 7 , a perspective view of hat piece 28 is shown. A plurality of smart spheres 30 are mounted in hat piece 28 . In a preferred embodiment, each of the smart spheres 30 is supplied with coolant by cooling and grounding unit 14 and the coolant is circulated through each of the smart spheres 30 or each group of smart spheres 30 in a separate cooling circuit that is connected by means of a valve to a manifold (not shown) that is mounted in cooling and grounding unit 14 . Referring to FIGS. 8-10 , a preferred embodiment of smart sphere 30 is presented. As is the case with all preferred smart spheres 30 , these smart spheres 30 are connected to cooling and grounding unit 14 by inlet tube 36 and outlet tube 38 . Coolant (not shown) flowing in inlet tube 36 enters one of the smart spheres 30 , circulates through circuitous path (e.g., a labyrinth) within the smart sphere 30 and then exits through outlet tube 38 . In a preferred embodiment, the rate of flow of coolant circulating through each of the smart spheres is individually controlled by means of cooling and grounding unit 14 . A plurality of sensors 50 are shown mounted on the exterior surface of smart sphere 30 that is in contact with body 18 when apparatus 10 is in use. Sensors 50 are in communication with cooling and grounding unit 14 by means of leads 58 . In a preferred embodiment, all of sensors 50 are in contact with the skin of body 18 and one of sensors 50 is a grounding contact, a second of sensors 50 is a pulse sensor and a third of sensors 50 is a temperature sensor. In a preferred embodiment, each temperature sensor is a conventional thermocouple. Sensors 50 are located within compression garment 12 so as to allow a pulse to be taken at each extremity of body 18 , e.g., at each wrist and at each ankle. In a preferred embodiment, each smart sphere 30 is embedded in memory foam, indicated with cross hatching on FIGS. 9 and 10 . In a preferred embodiment, the coolant comprises medical grade propylene glycol, a surfactant (e.g., Jet Dry@ manufactured by Recldtt Benckiser Inc. of Parsippany, N.J.), iodine and distilled water. Referring to FIG. 11 , a perspective view of bladder assembly 60 is presented. Cross sectional views of bladder assembly 60 are presented in FIGS. 12 and 13 which reveal the layered nature of bladder assembly 60 . In this embodiment, bladder assembly 60 comprises air bladder 42 and fluidic bladder 44 . In a preferred embodiment, the version of fluidic bladder 44 that is used on the legs of body 18 is about two inches wide and about 28 inches long. Preferably, the version of fluidic bladder 44 that is used on the arms is about one inch wide and about 16 inches long. In FIG. 12 , air bladder 42 is shown inflated and in FIG. 13 fluidic bladder 44 is shown inflated. Each air bladder 42 is preferably in air pressure communication with core body cooling and grounding unit 14 via air bladder tubing 64 . In a preferred embodiment, each air bladder 42 is a conventional blood pressure cuff and is in communication with a sphygmomanometer (not shown) in cooling and grounding unit 14 . Each inflatable fluidic bladder 44 is preferably in fluidic communication with cooling and grounding unit 14 via fluidic bladder tubing 62 . In an alternative embodiment, the pulse in each extremity is measured by means of a conventional clip-type (clip-on) pulse sensor that is applied to a finger or toe of body 18 . Operation of apparatus 10 involves checking the blood pressure, pulse and temperature of each extremity of body 18 before and after each exercise activity involving compression, cooling and grounding. At the beginning of each activity, each air bladder 42 is inflated (pressurized with air or liquid coolant) sequentially (one after the other) until the blood flow (and hence, pulse) in that extremity is reduced. Then, the pressure within the air bladder 42 is decreased until a pulse is detected by the appropriate pulse sensor 50 , indicating that the pressure in the air bladder 42 is equal to the systolic pressure in that extremity. At that point, the air bladder 42 is deflated. After the blood pressure and pulse rate are measured in each extremity, each of the inflatable fluidic bladders 44 is inflated (pressured with a liquid), preferably until a target blood pressure in the extremity is reached. The liquid pressure within each fluidic bladder 44 is preferably controlled by means of a fluidic valve (not shown) that is mounted in cooling and grounding unit 14 . In a preferred embodiment, during the exercise activity, the fluid pressure in each fluidic bladder 44 is controlled to limit the blood pressure in each extremity to no more than about 120 percent of the initially measured blood pressure. Moreover, during the exercise activity, the pulse in each extremity is monitored and the fluidic pressure in the fluidic bladder 44 that is reducing blood circulation in that extremity is decreased or released (decreased to zero) if the monitored pulse in the extremity becomes reduced in rate or weak. Apparatus 10 allows the reduction of the core temperature of body 18 during exercise with reduced blood circulation in the extremities of body 18 . This reduction in core body temperature reduces the pain that is usually associated with reduced blood circulation in extremities of body 18 to manageable levels. Core body cooling also increases the blood density, which allows less pressure to be applied to body 18 to reduce blood circulation. Although the applicant does not wish to be held to any particular theory of operation of apparatus 10 , he believes that after a month of exercise activity using apparatus 10 , increased levels of human growth hormone are present in body 18 . Body 18 responds to the heightened levels of human growth hormone by growing another blood flow system (more blood vessels) in its extremities. In another alternative embodiment, compression wear 12 comprises fluidic bladders 44 that cause vascular constriction at the upper arms and upper legs. In this embodiment, fluidic bladders 44 have a hooks and loops closure, e.g., a Velcro@ closure. During exercise, this quickly leads to lactic acid accumulation and forces the blood into normally unused capillaries. After body 18 senses that its muscles contain lactic acid, extra growth hormones are produced and carried by the blood throughout the entire body. In a preferred embodiment, apparatus 10 is grounded to the earth during use. Grounding of body 18 by apparatus 10 creates a conductive path between the user of apparatus 10 and the earth. Grounding allows file earth's free electrons to flow to the body in order to maintain its natural free electron balance. This helps restore the body's natural electrical state so that chronic pain can immediately subside. In a preferred embodiment, body 18 is grounded by means of a separate grounding circuit which is provided between each smart sphere 30 and the ground via umbilical cable 15 . Preferably, the grounding circuit for body 18 does not go through a conventional electrical receptacle. In use, apparatus 10 allows the human subject using it to achieve lower core body temperature and increase the blood density. These effects are accomplished via a compliant heat exchanger in the form of a matrix of individual temperature control units, termed smart spheres. Each smart sphere adheres to the skin surface and removes the heat through heat exchange with the surface blood vessels. The same blood vessels are used as a vehicle to deliver the cooling temperature to the core of body 18 , thus lowering the core body temperature. As the temperature of body 18 decreases, the blood density is increased in a proportional manner. In a preferred embodiment, apparatus 10 absorbs heat from the outer surface of human body 18 by utilizing a conventional refrigerant cycle, with a resulting reduction in body temperature. In this embodiment, body heat input to the liquid in smart spheres 30 is transferred to a refrigerant, which absorbs the heat by boiling, to produce a vapor. This vapor is directed to a compressor that compresses the vapor and then to a condenser which simultaneously absorbs heat from the compressed vapor and rejects heat to the atmosphere. This causes the refrigerant to liquefy, and expand through an expansion valve, prior to being reintroduced to smart spheres 30 . By maintaining a given condenser pressure, the compressor loses its capacity as the intake pressure decreases, until a balance point is reached in which heat absorbed by smart sphere 30 (acting as a heat exchanger) matches the heat input to the heat exchanger. In a preferred embodiment, the refrigerant (coolant) is supplied to body thermal panels 12 at a temperature in the range from 44 degrees Fahrenheit (F) to 54 degrees F., in order to lower the core body temperature of the user to the range to about 96 degrees Fahrenheit (F). This temperature setting may be overridden, if desired. In a preferred embodiment, apparatus 10 applies pressure in the range from about 178 mm Hg to about 238 mm Hg to the blood vessels of the upper arms and upper thighs of the user in order to decrease the blood flow during the performance of an exercise protocol. Application of pressure on these blood vessels during exercise utilizing apparatus 10 causes body 18 to produce increased amounts of growth hormone in order to grow additional blood vessels and to provide adequate delivery of blood flow to the region within which blood flow is restricted. When a consistent regiment of exercise with vascular pressure is practiced, in time, additional “collateral circulation” is formed with the addition to the existing blood vessels, thus increasing overall blood flow in the region within which blood flow has been restricted. Increase in growth hormone secretions by body 18 results in a number of beneficial effects due to the presence of elevated growth hormone levels, such as increased metabolic rate, reduction of fat, increase in muscle size and strength, and overall increases in levels of human performance. In a preferred embodiment, apparatus 10 achieves ground contact of body 16 during the performance of an exercise protocol. During exercise, significant amounts of static electricity are generated by body 16 . Because body 16 operates on a bio/electrical principle, externally added high levels of static electricity interfere with and weaken the normal bio-electrical body functions, unless this extra electrical charge is released to the ground. Electrical ground contact also allows the transmission of neutral electrons from the earth to body 16 , thus balancing the body's natural bio/electrical levels. In a preferred embodiment, smart spheres 30 sense whether grounding has been achieved and grounding status of body 18 is displayed on display 16 prior to the start of the treatment protocol. Referring again to FIGS. 4 and 5 , compression garment 12 is shown to comprise a plurality of individual smart spheres 30 . Preferably, individual smart spheres 30 can be combined in any shape in a piece of clothing or equipment used to practice the methods disclosed herein. Preferably, each smart sphere 30 has its own flow and temperature control and it is imbedded in a memory foam. Thus, compression garment 12 is quite comfortable to wear. In a preferred embodiment, the software program that operates apparatus 10 comprises instruction that cause apparatus 10 to perform a number of process steps. In one step, the subject puts on compression garment 12 . In another step, garment 12 is connected to cooling and grounding unit 14 . In another step, display 16 on cooling and grounding unit 14 shows the blood pressure and pulse rate of the subject and confirms that a connection to ground has been established. In another step, the subject sits on a stationary bicycle or stands on a treadmill and selects an exercise protocol. In another step, apparatus 10 starts the cooling cycle and applies compression while monitoring the pulses, temperatures and pressures of the subject. In another step, the subject continues the exercise protocol until the timer on cooling and grounding unit 14 tells him to stop. In another step, at the completion of the exercise protocol, the subject removes compression garment 12 and either stores the sensed data (e.g., pulses, temperatures, pressures) in the cooling and grounding unit or downloads it to a remote computer. All of the functions of apparatus 12 are displayed in a digital format and can also be enunciated in a voice format. Referring to FIG. 14 , another preferred embodiment of apparatus 10 is shown in use in an emergency medical (ambulance) application for treatment of spine and head injuries. In this embodiment, apparatus 10 further comprises gurney or patient transport unit 66 . Cooling and grounding unit 14 does not provide grounding of body 18 when apparatus 10 is being moved, but may provide grounding when apparatus 10 is stationary. In this embodiment, smart spheres 30 are preferably provided in head piece 28 and along the spine of body 18 and may be provided in other locations in garment 12 . Referring to FIGS. 15 and 16 , another preferred embodiment of the invention is illustrated. In this embodiment, the user's body 18 is seated on vehicle seat 80 which is preferably temperature controlled by means of integral seat (e.g., back and bottom) heat exchangers 82 and safety belt heat exchanger 84 which is integral to safety belt 86 . Circulation of a fluid through heat exchangers 82 and 84 ensures that the core body temperature of the user is closely regulated. In this embodiment, inflatable fluidic bladders 44 preferably encircle the upper arms and upper thighs of the user. These fluidic bladders are preferably inflated to a pressure that is approximately thirty percent greater than the systolic blood pressure of the user in a cyclic manner. Preferably, pressure is applied to body 18 at a frequency that is in the range from about thirty times per minute to about sixty times per minute, with a more preferred frequency being about thirty times per minute. This cyclic vascular compression process of the limbs simulates walking. Operation of the system is controlled by human interface 90 . Cyclic vascular compression can also be used to simulate walking while the user is swimming. In this embodiment, the inflatable fluidic bladders 44 that encircle the upper arms and upper thighs of the user are inflated cyclically as described above. This cyclic vascular compression increases venous blood flow and thereby increases oxygenation of the muscles in the swimmer's arms and legs. Many variations of the invention will occur to those skilled in the art. Some variations include cooling, compression and grounding of one body part. Other variations call for cooling, compression and grounding of more than one body part. All such variations are intended to be within the scope and spirit of the invention. In the case of portable variations of this invention, grounding may not be possible while apparatus 10 is being moved. Although some embodiments are shown to include certain features, the applicant(s) specifically contemplate that any feature disclosed herein may be used together or in combination with any other feature on any embodiment of the invention. It is also contemplated that any feature may be specifically excluded from any embodiment of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of International Patent Application No. PCT/CH2006/000673 filed Nov. 30, 2006, which claims priority to German Patent Application No. DE 10 2005 060 928.7 filed Dec. 20, 2005, the contents of both of which are herein incorporated by reference. BACKGROUND [0002] The present invention relates to devices for delivering, injecting, administering, infusing or dispensing a substance, and to methods of making and using such devices. In some embodiments, the present invention relates to an injection device for an injectable product, e.g. a liquid medicament such as insulin, a growth hormone, an osteoporosis preparation, etc. [0003] Patent specification EP 1 351 732 B1 discloses an injection device with a housing, in which a reservoir for an injectable product and, accommodated in the reservoir, a dose setting and forward drive unit for a conveyor plunger are disposed. The dose setting and forward drive unit comprises a dose setting element which can be rotated and axially displaced in a thread engagement with the housing to set a product dose. The dose setting element engages a plunger rod in a rotational lock, which permits relative axial movements between the plunger rod and the dose setting element. The dose setting and forward drive unit also has a force transmitting element in the form of a compression spring, which biases the dose setting element axially by an elastic force. The force transmitting element is tensed when the product dose is increased during the setting operation. The plunger rod sits in a thread engagement with the housing and is retained so that it can not rotate relative to the housing when the product dose is being set. The dose setting element simultaneously also serves as a display element for displaying the set dose. The threads of the dose setting element and housing forming part of the thread engagement have a thread pitch which is large enough so that when axial pressure is applied to the dose setting element, it rotates in said thread engagement and is not retained by self-locking. Due to the correspondingly long axial setting path, the markings of the dose scale can likewise be distributed across a correspondingly long length, which is beneficial to enabling a reading to be taken. The disadvantage, however, is that the known injection device is of a correspondingly long length. A trigger for activating the dispensing of the set dose is disposed in an axially central region of the housing. This makes it more difficult to manipulate the injection device during the injection, namely to trigger the dispensing operation. [0004] In another injection device known from patent specification DE 198 21 934 C1, a dose setting element is disposed in the reservoir so that it is not able to move, thereby enabling the installation-length to be reduced. The dose setting element is provided with several stops, each one of which restricts the stroke of a plunger rod during dispensing operations which can be effected one after the other and thus defines the dose which can be administered with each dispensing operation. However, the individual doses can not be freely selected as is the case with the dose setting and display element disclosed in EP 1 351 732. SUMMARY [0005] One object of the present invention is to provide an injection device with an axially displaceable dose setting and/or display element of an ergonomically conducive design with as long as possible an axial displacement path. [0006] In one embodiment, the present invention comprises an injection device comprising a housing with a reservoir for an injectable product, a plunger axially movable in a direction of propulsion in the reservoir, a dosing and propulsion mechanism for the plunger and arranged in an axial continuation of the reservoir, a dosing and/or display member moveable in one axial direction relative to the plunger when setting a product dose and moveable in the opposite direction when the dose is dispensed, and, optionally, a force-imparting member which forces the dosing and/or display member in the direction of an axial end position, wherein at least one of the dosing and/or display member and optional force-imparting member axially overlap the reservoir at least when the dosing or display member is in the end position. [0007] In one embodiment, the present invention comprises an injection device comprising a housing with a reservoir for an injectable product, a plunger axially movable in the reservoir in a direction of propulsion, a dosing and propulsion driver provided for the plunger and arranged in an axial continuation of the reservoir, an element, comprising at least one of a dosing member and display member, said element moveable in one axial direction relative to the plunger when setting a product dose and in the opposite direction when the dose is dispensed, and a force-imparting member which forces the element in the direction of an axial end position, wherein at least one of the element and force-imparting member axially overlaps the reservoir, at least when the element is in the end position. In one embodiment, the injection device further comprises a manually operable operating knob which can be moved, by a rotating movement, backward and forward relative to the housing for setting the dose, the knob being kinematically coupled to the element to be prevented from rotating. [0008] In one embodiment, the present invention comprises an injection device comprising a housing with a reservoir for an injectable product, a plunger which is axially movable in a direction of propulsion in the reservoir, a dosing and propulsion means provided for the plunger and arranged in an axial continuation of the reservoir, with a dosing or display member which is moved in one axial direction relative to the plunger when setting a product dose and is moved in the opposite direction when the dose is dispensed, and, optionally, a force-imparting member which forces the dosing or display member in the direction of an axial end position, wherein at least one out of the dosing or display member and optional force-imparting member axially overlaps the reservoir, at least with the dosing or display member in the end position. [0009] In one embodiment, the present invention comprises an injection device comprising a housing with a reservoir for an injectable product, a plunger axially displaceable in the reservoir in a forward drive direction and a dose setting and forward drive unit, which is disposed in an axial extension of the reservoir, i.e. along a displacement axis of the plunger adjacent to the reservoir. The housing may serve directly as the reservoir but, in some embodiments, the housing merely constitutes a holder for a product container, which may be an ampoule with the plunger accommodated in it. The dose setting and forward drive unit has a dose setting or display element, which may assume the function of only dose setting element, only display element, or a dose setting and display element in combination. (The word “or” is used in the sense of “and/or,” i.e. in the logical sense with reference to the dose setting or display element and otherwise, unless otherwise stated in the respective context.) The dose setting or display element can be moved backward and forward axially relative to the plunger and reservoir, and moves in an axial direction relative to the plunger when a product dose to be administered is being set, and moves back in the opposite direction as the dose is being dispensed. In some preferred embodiments, the ability to move axially is restricted by a stop predefining an axial end position as far as which the display element can be moved for at least one of the two axial directions. In some preferred embodiments, an axial end position is predefined by a contact with a stop contact in both directions of the axial movement so that the dose setting or display element can be moved in a defined manner up to a stop in one direction as far as a maximum dose position and in the other direction as far as a minimum dose position, e.g. the zero dose position. [0010] In some embodiments, the injection device may have a force transmitting element, which biases the dose setting or display element with a force in one of the two axial directions. Although the injection device may be equipped with a force transmitting element, such a force transmitting element need not necessarily be provided, i.e. it is an optional force transmitting element. In some embodiments, the optional force transmitting element may generate the force needed to dispense a set or selected dose. [0011] If no force transmitting element is provided, the user must apply the force needed to drive the plunger during the dispensing operation. In embodiments of this type, the dose setting or display unit may be extracted from the housing in the proximal direction when setting the dose and pushed backed deeper into the housing by the user during the dispensing operation. Optionally, an operating element moving out of the housing may act on the dose setting element by a gear during the dispensing operation. [0012] In some preferred embodiments, when setting the dose, the dose setting or display element moves in the proximal direction and accordingly moves in the distal direction toward the injection site during the dispensing operation. This applies to embodiments which are not provided with a force transmitting element, namely if the dispensing operation is effected by applying axial pressure to the dose setting or display element or an operating element coupled with it by a gear mechanism. Although this operating sequence may be preferred for the dose setting or display element, the direction of movement for the setting operation and dispensing operation may just as easily be reversed if the force transmitting element is provided. [0013] In accordance with some embodiments of the present invention, the dose setting or display element overlaps the reservoir, at least on assuming the at least one axial end position. If the injection device is provided with the optional force transmitting element, at least one of the dose setting or display element and the optional force transmitting element overlap the reservoir, at least when the dose setting or display element assumes the at least one axial end position. If the force transmitting element is provided, only the dose setting or display element overlaps the reservoir in such embodiments. In alternative embodiments, however, it is also possible for only the force transmitting element to be disposed in a position axially overlapping the reservoir. In yet another alternative, it is also possible for both the dose setting or display element and the force transmitting element be positioned axially overlapping the reservoir. If the force transmitting element overlaps, it may be axially supported on the housing, either directly or via an intermediate element, e.g. in the region of the overlap, in every axial position of the dose setting or display element. If, as in some preferred embodiments, the dose setting or display element overlaps, it does so in the axial end position assumed after dispensing the set dose. [0014] In the at least one end position, the dose setting or display element or the optional force transmitting element overlaps or overlap not only a rear portion of the reservoir in relation to the forward drive direction, but advantageously also axially overlap the plunger. In some preferred embodiments, the dose setting or display element or the optional force transmitting element extend beyond the plunger in the forward drive direction, and in some preferred embodiments, at least do not locate behind the front end of the plunger. [0015] Due to the overlap in the direction in which the dose setting or display element moves, the length of the injection device can be kept within ergonomically conducive limits, even in situations where the dose setting or display element is to be enabled to cover an axially long displacement path when setting the dose. From a tactile point of view, long displacement paths are beneficial for setting an exact dose if the dose is set by moving the dose setting or display element. Long displacement paths also offer an advantage on a purely display element because the dose scale can be distributed across a long distance corresponding to the displacement path. [0016] If the dose setting or display element is a combined dose setting and display element in one, or if it constitutes a display element of the injection device and a pure or dedicated dose setting element is provided in addition, and the position it assumes after setting the dose defines the conveying stroke of the plunger, e.g. by a stop on reaching the minimum dose position, the dose setting and display element or the display element may serve as a support for the dose scale. The dose scale may alternatively be applied to or incorporated in the housing and the pure display element or the dose setting and display element serve as a support for a marking which migrates along the dose scale, for example in the form of a reading strip. In some preferred embodiments, the dose setting or display element combines the functions of setting the dose and providing a display, in which case the injection device of the present invention offers said advantages of the two functions in combination. [0017] The dose setting or display element may move solely in translation, i.e. only axially. Advantageously, however, it can also be rotated about a rotation axis pointing in the axial direction. In some preferred embodiments, the translating and rotating movements are forcibly superimposed on one another, to which end the dose setting or display element forms a link element of a screw joint, the other link element of which may be formed by the housing. The two link elements sit in a threaded engagement with a thread pitch which is large enough so that an axial force applied to the dose setting or display element, e.g. a pressing force, when in the thread engagement causes a rotation of the dose setting and display element with a superimposed translating movement. The two engaged threads are therefore not self-locking. The dose setting or display element advantageously sits in a direct threaded engagement with the housing. Optionally, it is not coupled with the housing directly, but instead is coupled with it kinematically via one or more intermediate elements which can be displaced relative to the housing, i.e. slip-free. During the movement of the dose setting or display element, intermediate elements fixedly connected to the housing may be regarded as belonging to the housing as far as the movement of the dose setting or display element is concerned. [0018] If the at least one end position is defined by a stop, as in some preferred embodiments, the stop maybe an axial stop against which the dose setting or display element presses in the axial direction on reaching the end position. If a rotating movement is superimposed on the axial movement, the stop may also be an axial stop or alternatively a radial or rotation stop, with which the dose setting or display element makes an abutting contact during the rotation in the circumferential direction about the rotation axis when it has reached the at least one end position. [0019] In some embodiments, to provide a defined displacement of the dose setting or display element during the setting operation and also during the dispensing operation, the dose setting and display element is provided with a mating region in the form of a thread as described above, for example in the form of a linear guide with catch elements disposed axially adjacent to one another. In preferred embodiments wherein the dose setting or display element can be moved in an axially overlapping arrangement with the plunger, the mating region of the dose setting or display element also overlaps the plunger, advantageously up to at least its front end. [0020] The force transmitting element, if provided, in some embodiments may be a spring element, which biases the dose setting element with an elastic force. This being the case, it may be a pneumatic or a mechanical spring element. In embodiments involving a spring element, the latter releases the elastic energy stored previously during the operation of setting the product dose during the dispensing operation and thus supplies the energy needed to drive the plunger forwards. The user only has to operate a trigger. Irrespective of the type of force transmitting element used, the end position in which the dose setting and display element overlaps the reservoir just or to the farthest point is the minimum dose position or the maximum dose position. If the force transmitting element is a compression spring, it acts on the dose setting or display element in the direction toward the minimum dose position (this direction coincides with the distal direction). If the compression spring is disposed distally of the dose setting or display element, its elastic force acts in the proximal direction. If the force transmitting element is a tension spring, for example, the directional relationship can be reversed. A situation where the actual force transmitting element has practically no relevant elasticity should also not be ruled out, and instead it may be formed by an electric motor, for example, which permits or also effects a dose setting movement of the dose setting element when the dose is being set or alternatively causes it by a motor driving action after a separately effected setting operation depending on the setting and also causes a dispensing movement of the dose setting element by a motor driving action when manually triggered. [0021] In fulfilling the function of a dose setting element, the dose setting or display element may extend out of the housing so that it forms a manually operable dose setting knob itself, in which case the portion extending out of the housing may be formed integrally with the remaining part of the dose setting element or may be fixedly connected to it. In this case, the dose setting or display element moves out of the housing during the operation of setting the dose and is moved back into the housing in the direction toward the minimum dose position again during the dispensing operation, this advantageously being done by the user pushing on the dose setting or display element in the distal direction. [0022] In some embodiments, if a force transmitting element is provided, the dose setting or display element does not move out of the housing and instead moves backward and forward inside the housing during setting and dispensing the dose. [0023] In embodiments incorporating a force transmitting element, the dose setting or display element may be provided in the form of a dose setting coupling retained in the respective dose setting position relative to the housing against the force of the force transmitting element. The dose setting coupling comprises coupling elements, which are in a coupled engagement with one another when the dose is being set. The coupled engagement is released for the dispensing operation so that the dose setting or display element is able to move in the direction toward the end position under the force of the force transmitting element. If the dose setting or display element does not itself extend out of the housing or is fixedly connected to a dose setting knob which can gripped and held, the dose setting coupling provides a coupling between the dose setting or display element and a dose setting knob which is accessible to the user and can therefore be manually operated to set the dose. To dispense the set dose, the dose setting coupling is released and the dose setting or display element is uncoupled from the externally accessible dose setting knob as a result. To release the coupled engagement, the injection device has an operating knob serving as a trigger. In some preferred embodiments, the operating knob is disposed on a proximal end of the injection device and may advantageously be operated with the thumb of the same hand as that with which the user holds the injection device during the injection. [0024] In some preferred embodiments the operating knob constitutes the proximal end of the injection device. It is also of advantage if the operating knob also serves as the dose setting knob and thus fulfils a dual function. In embodiments both without and with the force transmitting element, the same manually operable operating knob acts both as the dose setting knob and the trigger, operation of which causes the dispensing operation. [0025] In some preferred embodiments, the injection device has a dispensing coupling, which provides a kinematic coupling between the dose setting or display element and a plunger for the dispensing operation, i.e. slip-free. During the operation of setting the dose, the coupled engagement of the coupling elements constituting the dispensing coupling is released so that the dose setting or display element is uncoupled from the plunger rod. In embodiments in which the injection device has a dose setting coupling for providing a coupling between the dose setting or display element and said dose setting knob during the operation of setting the dose and a dispensing coupling for providing a coupling between the dose setting or display element and the plunger rod during the dispensing operation, the two couplings are “switched” so that when triggered by operating said operating knob, the dose setting coupling is automatically released and the dispensing coupling closed. BRIEF DESCRIPTION OF THE DRAWINGS [0026] FIG. 1 is a view of one embodiment of an injection device in accordance with the present invention; [0027] FIG. 2 shows the injection device in longitudinal section; [0028] FIG. 3 shows the proximal portion of the injection device in longitudinal section; [0029] FIG. 4 shows an embodiment of a dose setting coupling in a coupled engagement; [0030] FIG. 5 shows an embodiment of a housing portion and an operating knob; and [0031] FIG. 6 shows an embodiment of a dispensing coupling out of engagement. DETAILED DESCRIPTION [0032] With regard to fastening, mounting, attaching or connecting components of the present invention, unless specifically described as otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electrical system of the invention, if any. In embodiments with electrical features or components, suitable electrical components and circuitry, wires, wireless components, chips, boards, microprocessors, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials for making the invention and/or its components may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc. [0033] FIG. 1 shows a side view of an embodiment of an injection device in accordance with the present invention. The injection device is a longitudinally extending, slim injection pen. It comprises a housing with a distal (or front) housing portion 1 and a proximal (or rear) housing portion made up of two housing portions 2 and 3 fixedly connected to one another. The injection device is used to administer a liquid medicament, for example insulin. The medicament is contained in a reservoir, which can be replaced by inserting it in the housing portion 1 . The medicament can be administered through an outlet 1 a provided at the distal end of the housing portion 1 . By reference to a central longitudinal axis RT, the injection device is essentially rotationally symmetrical. The housing portions 1 - 3 are each made from a non-transparent plastic material. To make it possible to see through to the reservoir, housing portion 1 has a window 1 b , which extends up to or close to the proximal end of housing portion 1 and close to the outlet 1 a , but is relatively slim in the circumferential direction about the axis RT. Housing portion 2 likewise has a window 2 b , which overlaps the window 1 b when housing portions 1 and 2 are connected, providing a free view through to the reservoir in the connecting region of housing portions 1 and 2 . The windows 1 b and 2 b are of the same width in the circumferential direction, but could conceivably be of different dimensions in the circumferential direction, provided the function of providing a view through to the reservoir can be fulfilled. Another window 4 in the form of a magnifying glass is also provided in housing portion 3 . An operating knob 27 forms the proximal end of the injection device. The operating knob 27 fulfils the function of a manually operable dose setting knob, which enables a dose to be selected or set for a medicament to be administered when operated and also serves as a trigger button enabling the set dose to be dispensed when operated. The set dose can be read through the window 4 on a dose scale extending continuously below the window 4 during the setting operation. [0034] FIGS. 2 and 3 each illustrate the injection device in a longitudinal section containing the longitudinal axis RT, FIG. 2 showing it as a whole and FIG. 3 illustrating the proximal portion on a larger scale. [0035] The reservoir R is an ampoule made from glass or transparent plastic. Disposed in the reservoir R is a plunger 10 which can be moved axially in a forward drive direction V toward the outlet 1 a . In the initial state illustrated in FIGS. 2 and 3 , the reservoir R is completely full and the plunger 10 closing off the reservoir R at the proximal end assumes its most proximal position. Basically, the housing portion 1 merely serves as a reservoir holder. It is fixedly connected to the housing portion 2 but can be released by screwing, for example, to enable the reservoir 1 to be replaced. [0036] Portions 2 and 3 constituting the proximal housing portion are likewise fixedly connected to one another, e.g. by a material join, and may be regarded as a single housing portion in terms of their function. The housing portion formed by the two portions 2 , 3 provides a mount for or carries a dose setting and forward drive mechanism, by which a dose of medicament can be set or selected for dispensing with each injection and the set dose can be dispensed by the forward driving action of the plunger 10 . The operating knob 27 is coupled with the dose setting and forward drive mechanism for setting the dose by a dose setting coupling. [0037] The dose setting and forward drive mechanism comprises several elements, which are coupled with one another in different ways by the dose setting coupling and a dispensing coupling when the dose is being set and dispensed. A plunger rod 11 is one of these elements. During the dispensing operation, the plunger rod 11 pushes against the rear face of the plunger 10 so that it moves in the forward drive direction V and dispenses medicament through the outlet 1 a . The plunger rod 11 sits in a threaded engagement with the housing portion 2 , for which purpose it is provided with a thread across the major part of its length. Housing portion 2 constitutes the co-operating thread on a retaining mechanism 2 a ( FIG. 3 ) projecting radially inward toward the plunger rod 11 . The forward driving movement of the plunger rod 11 is a rotating movement about the longitudinal axis RT with a translating movement in the forward drive direction V superimposed on it. The thread of the plunger rod 11 is not continuous but is interrupted by an axially flat face or groove. However, this does not cause any interruption to the thread engagement with the retaining mechanism 2 a and the plunger rod 11 retained in the thread engagement. [0038] The dose setting and forward drive mechanism also has a first coupling element 12 , a second coupling element 16 and a third coupling element 22 . Coupling element 12 is able to move axially with the plunger rod 11 along its flat face or groove in a guiding engagement but is connected so that it is prevented from rotating. The coupling element 12 is disposed proximally of the retaining mechanism 2 a and pushes against the retaining mechanism 2 a in the forward drive direction V. The coupling element 12 surrounds the plunger rod 11 . The coupling element 12 comprises a distal portion which sits in contact with the retaining mechanism 2 a and a proximal portion which extends as far as the operating knob 27 . A spring 13 is provided between the two portions. Another spring 14 is provided on the distal end of the coupling element 12 , which has several resilient lugs which project in the direction toward the retaining mechanism 2 a and are elastically biased. The resilient lugs of the spring 14 act as catch elements, which latch with catch elements of the retaining mechanism 2 a , thereby providing an anti-rotation slip coupling between the coupling element 12 and the retaining mechanism 2 a and hence housing portion 2 , which prevents the plunger rod 11 from rotating relative to the housing 1 - 3 during dispensing operations. However, the force which can be transmitted when the catch elements and co-operating catch elements of the anti-rotation coupling is not so strong that it prevents the rotating movement of the plunger rod 11 needed to dispense the set dose or prevents it to only a practically relevant degree. In the portion of the spring 13 , the coupling element 12 may flex axially. The coupling element 12 incorporating the two springs 13 and 14 is made integrally from plastic, for example by an injection moulding process. [0039] The coupling element 16 is mounted so that it can rotate about the axis RT. It is a generally cylindrical, sleeve-shaped body and surrounds the coupling element 12 . Integrally formed on the distal end of the coupling element 16 is a spring 17 , which in the embodiment illustrated as an example is an axially short helical spring. The coupling element 16 is supported by its spring 17 on the coupling element 12 in the distal direction and pushes it against the retaining mechanism 2 a . Formed on the proximal end of the coupling element 16 are mating elements 20 , which sit in a releasable coupled engagement with co-operating mating elements 24 of the coupling element 22 when the injection device is in the state illustrated. The mating elements 20 and co-operating mating elements 24 may be teeth projecting axially out from the coupling element 16 or 22 in the direction toward the other ones, which form two toothed rings locating with one another in the coupled engagement concentric with the axis RT, e.g. with a uniform tooth distribution, as illustrated by way of example in FIG. 4 . In the state illustrated, in which the user is able to set the dose to be administered, the mating elements 20 and co-operating mating elements 24 of the two coupling elements 16 and 22 locate in one another. The coupling elements 16 and 22 constitute the dose setting coupling and are connected to one another so that they can not rotate in the coupled engagement. [0040] FIG. 4 illustrates the coupling halves of the dose setting coupling, namely the coupling elements 16 and 22 , in the coupled engagement and removed from the overall context so that their functional elements 17 - 20 on the one hand and 23 - 25 on the other hand are more readily visible. [0041] The coupling element 22 is likewise sleeve-shaped and has a flange projecting radially outward at its proximal end. Formed on the external circumference of the flange are mating elements 25 , which connect the coupling element 22 to the operating knob 27 so that it can not rotate. The coupling element 22 is axially supported on the operating knob 27 by a spring 23 . The spring 23 is an integrated part of the coupling element 22 insofar as the coupling element 22 is made from plastic in one piece incorporating the spring 23 . Like spring 14 , spring 23 comprises several resilient lugs projecting axially out and bent about the axis RT. In conjunction with the spring 17 , it ensures that the coupling elements 16 and 22 are elastically retained axially in the coupled engagement. The spring 17 pushes the coupling element 16 and the spring 23 pushes the coupling element 22 axially in each case into contact with the housing portion 3 . [0042] The coupling element 22 is in a threaded engagement with a stop element 26 . To this end, the coupling element 22 is provided with a thread 22 a ( FIG. 4 ) on its external circumference before the flange. The housing portion 3 acts an axial guide 7 for the stop element 26 lying radially outward opposite the thread 22 a so that the stop element 26 is moved axially in the threaded engagement when the coupling element 22 is moved in rotation. The axial displacement path of the stop element 26 corresponds to the quantity of medicament which is available as a maximum and can be administered in several injections, i.e. when the reservoir R is full. When the coupling element 22 is moved in rotation, the stop element 26 migrates, guided by the axial guide 7 along the external thread 22 a of the coupling element 22 , in the axial direction, which is the forward drive direction V in the embodiment illustrated as an example. Once the stop element 26 reaches an axial stop formed by the inner sleeve 6 in this direction of movement, it means that the reservoir R has been completely emptied. The inner sleeve 6 acts as the axial guide 7 and is not able to move axially relative to the housing portion 3 , and, in the embodiment illustrated as an example, is formed on the housing portion 3 by a radial connecting web, i.e. is an integral part of the housing portion 3 . [0043] The dose setting and forward drive mechanism also has a dose setting and display element 30 , which is in a threaded engagement with the housing portion 3 . To provide this engagement, the housing portion 3 is provided with an internal thread 3 a . Housing portion 2 is smooth in the contact region with the dose setting and display element 30 . The thread 3 a is disposed directly on the internal surface of the circular cylindrical sleeve shell of the housing portion 2 , 3 . The dose setting and display element 30 is essentially a simple circular cylindrical sleeve with an external thread 30 a of complementary shape. The threads 3 a and 30 a have a significantly bigger, or larger or higher, thread pitch than the threads of the plunger rod 11 and retaining mechanism 2 a . The thread pitch is large enough to prevent retention in the thread engagement by friction and the dose setting and display element 30 is rotated and moved axially under the effect of a purely axial force relative to the housing portion made up of two parts in the threaded engagement. [0044] The dose setting and display element 30 may be moved axially but is coupled with the coupling element 16 so that it is prevented from rotating. In the embodiment illustrated as an example, the dose setting and display element 30 and the coupling element 16 sit directly in an appropriate guided engagement with one another. To this end, the coupling element 16 forms an axial guide 18 at its external circumference. A mating element 31 projects out from the internal face of the dose setting and display element 30 , by which the dose setting and display element 30 is in a guided engagement with the coupling element 16 , i.e. with its guide 18 . The guide 18 extends across the major part of the length of the coupling element 16 and the dose setting and display element 30 travels through the major part of its length when setting the maximum dose. The guide 18 is formed by axial grooves in the external surface of the coupling element 16 ( FIG. 4 ). At their distal ends, the grooves each serve as a stop 19 for the mating element 31 . [0045] The dose setting and forward drive mechanism comprises a spring element 32 , which applies a force to the dose setting and display element 30 in the distal direction. The spring element 32 , in the embodiment illustrated as an example, is a helical spring and acts as a compression spring. The spring element 32 is supported on the housing portion 3 in the proximal direction. In the distal direction, the spring element 32 is supported on an annular sliding disc 33 , inserted between the coupling element 16 and the dose setting and display element 30 and is in turn supported on the mating element 31 . By the sliding disc 33 , the spring element 32 is largely uncoupled from any rotating movements of the dose setting and display element 30 . [0046] The dose setting and display element 30 is able to move backward and forward relative to the plunger 10 and the plunger rod 11 and relative to the coupling elements 12 , 16 and 22 between axial end positions. The two end positions are a zero dose position and a maximum dose position. The two end positions are each predefined by a stop. The stop for the zero dose position is formed by a shoulder 2 c at the distal end of the housing portion 2 and serves as an axial stop. The stop for the maximum position is formed by the housing portion 3 . In the zero dose position, a distal portion of the dose setting and display element 30 overlaps the reservoir R in the forward drive direction V to beyond the plunger 10 when the plunger 10 assumes a rearmost position in the reservoir R as illustrated in FIGS. 2 and 3 . The plunger 10 assumes this position when the reservoir R is completely full. The thread 30 a extends as far as the distal end or at least close to the distal end of the dose setting and display element 30 so that the thread 30 a also axially overlaps the reservoir R and the plunger 10 when the dose setting and display element 30 assumes the zero dose position. The thread 30 a terminates before the distal end of the dose setting element 30 and in conjunction with the thread 3 a of the housing portion 3 forms an anti-rotation stop, which defines the maximum dose position of the dose setting and display element. Alternatively, the thread 30 a could also terminate at the distal end of the dose setting and display element 30 ; the stop defining the maximum dose position would then be of a different design in the event of such a modification. [0047] At its distal end, the dose setting and display element 30 is not circumferentially completely cylindrical but part-cylindrical so that, in spite of the axial overlap, the view onto the plunger is exposed if the dose setting and display element 30 is not made from a transparent plastic material, although this is preferred, but is made from a non-transparent or opaque plastic material or some other material. The distal edge of the dose setting and display element 30 extends in a spiral shape about the axis RT so that the dose setting and display element 30 stands out axially by its distal end in a circumferential region, even beyond the plunger 10 , as may be seen from FIGS. 2 and 3 , and sits back behind the plunger 10 in another circumferential region overlapping the window in the zero dose position so that the plunger 10 can be observed through the windows 1 b and 2 b . Instead of a spiral-shaped edge, the dose setting and display element 30 may extend circumferentially up to the same axial height all round with the exception of an interrupted region, for example, and thus extends across the plunger 10 in the forward drive direction V with the exception of the interrupted region, in which case the interruption would overlap with the window 2 b in the zero dose position. The shoulder 2 c of the housing portion 2 likewise winds about the axis RT following the spiral path of the distal edge of the dose setting and display element 30 , likewise winding about the axis RT. The winding course of the shoulder 2 c may also be seen in FIG. 1 . The housing portion 2 has an outer sleeve, which encloses the dose setting and forward drive mechanism in conjunction with the housing portion 3 , and an inner sleeve which is connected to the outer sleeve at its distal end by a web forming the shoulder 2 c , and the proximal end of which projects radially inward toward the retaining mechanism 2 a . An annular gap is left free between the outer and the inner sleeve, through which the dose setting and display element 30 extends across the greater part of its length in the zero dose position, and the greater part in the region of the longest circumferential segment of the dose setting and display element 30 amounts to approximately 50% of the total length of the dose setting and display element 30 . [0048] The dose setting and display element 30 provides a support for a dose scale, which extends round in a spiral on the external circumference of the dose setting and display element 30 with a pitch which corresponds to the pitch of the thread 30 a as measured by reference to the axis RT. The dose scale is made up of markings and numbers, each of the markings corresponding to a smallest dose unit which can be set. During the operation of setting the dose to be administered, the dose scale can be read through the window 4 of the housing portion 3 ( FIG. 1 ). [0049] The operating knob 27 forms the proximal end of the injection device. It clips onto the housing portion 3 by a shoulder 5 provided on the proximal end of the housing portion 3 , which grips behind the operating knob 27 . The operating knob 27 is able to rotate relative to the housing 1 - 3 about the axis RT in a dose setting direction and a correction direction. When setting the dose, the dose is increased by rotating the operating knob 27 in the dose setting direction and reduced in a rotating movement in the correction direction, thereby enabling a dose that has been accidentally set too high to be corrected. The operating knob 27 is also axially displaceable with the coupling element 22 but is connected so that it is prevented from rotating by the mating elements 25 . [0050] FIG. 5 illustrates the housing portion 3 and the operating knob 27 in the coupled engagement, with part of the operating knob cut away to illustrate the engagement. [0051] Due to the anti-rotation lock with the coupling element 22 , the operating knob 27 forms a slip coupling, in the embodiment illustrated as an example, an anti-rotation slip coupling, with the housing portion 3 . Several catch elements 28 are disposed on the operating knob 27 , uniformly distributed about the axis RT forming the slip coupling, which sit in a coupled engagement with co-operating complementary catch elements 8 preferably congruently disposed on the distal end of the housing portion 3 . The number of complementary catch elements 8 is lower than the number of catch elements 28 . When the coupled engagement is established between the catch elements 28 and complementary catch elements 8 , the operating knob 27 can be rotated relative to the housing portion 3 about the axis RT, and the catch elements 28 and complementary catch elements 8 are able to latch with one another in a releasable arrangement in pairs distributed discretely about the circumference. The pitch of the catch elements 28 and hence the distance as measured in the angle or arc dimension between the respective adjacently disposed catch elements 28 in the circumferential direction corresponds to the smallest dose unit which can be set and the pitch of the complementary catch elements corresponds to a whole number multiple of the same dose unit. The slip coupling need not necessarily be disposed directly between the housing 1 - 3 and the operating knob 27 . Instead of providing the catch elements 28 on the operating knob 27 , they could also be disposed on the coupling element 22 . Modified catch elements and complementary catch elements could also locate in one another axially rather than radially in both embodiments. [0052] The catch elements 28 and accordingly the complementary catch elements 8 are of an asymmetrical shape with reference to the direction of rotation so that the force needed to release the catch engagement in a coupling dose setting direction is stronger than in the opposite direction of rotation, namely the coupling correction direction. Since the catch elements 28 are disposed directly on the operating knob 27 in the exemplary embodiment, the dose setting direction of the operating knob 27 is simultaneously the coupling dose setting direction, and the correction direction is the coupling correction direction. The complementary catch elements 8 are catch cams projecting radially outward from the external surface of housing portion 3 . Accordingly, the catch elements 28 are provided in the form of co-operating recesses or tooth gaps of internal teeth on the facing, opposite internal surface of the operating knob 27 . To obtain the asymmetry for the two directions of rotation, the leading edges of the catch elements 28 pointing in the coupling dose setting direction as the catch elements move 28 are flatter than the trailing edges pointing in the opposite direction of rotation. The two edges of the complementary catch elements 8 are likewise shaped accordingly. [0053] The asymmetry of the slip coupling by reference to the two rotation directions of the operating knob 27 is adapted to the direction of the force expended by the force transmitting element 32 on the dose setting and display element 30 . As the operating knob 27 is moved in the direction for increasing the dose, the dose setting and display element 30 is rotated in the thread engagement due to the dose setting coupling formed at 20 , 24 and the guide coupling formed at 18 and 31 , and moves in the proximal direction. During the course of the translating movement in the proximal direction, the spring element 32 is tensed to an increasing degree. The elastic force of the spring element 32 produces a resistance countering the movement of the dose setting and display element 30 in the proximal direction, which acts on the slip coupling due to the coupling described above, and an additional frictional resistance which increases as the dose is increased counteracts the rotating movement of the operating knob 27 in the dose setting direction, in which the flatter edges of the catch elements 28 and complementary catch elements 8 point. Conversely, the force expended by the spring element 32 assists the rotating movement in the direction of a dose correction. [0054] FIG. 5 illustrates the housing portion 3 and its complementary catch elements 8 for the slip coupling. The housing portion 3 forms coupling springs 9 which are radially elastically flexible in a proximal sleeve portion, namely one coupling spring 9 per complementary catch element 8 . The complementary catch elements 8 respectively project radially outward from the coupling springs 9 . The coupling springs 9 are circle segments. The sleeve portion comprises the coupling springs 9 extending about the axis RT, alternating with circle segments which are stiffer than them. The coupling springs 9 respectively act as bending beams extending in the circumferential direction which are biased on both sides, namely on the two respective stiffer circle segments disposed closest. Extending in the circumferential direction along the coupling springs 9 is a respective recess, thereby increasing the flexibility of the respective coupling spring 9 . The sleeve portion incorporating the coupling springs 9 forms the proximal end of the housing portion 3 . [0055] The operating knob 27 is pot-shaped with a base constituting the distal end of the injection device and a wall projecting out from the base extending about the axis RT, on the internal face of which the catch elements 8 are uniformly distributed about the circumference and each shaped as an axially extending recess. In the assembled state, the catch elements 28 engage with both the complementary catch elements 8 and the mating elements 25 ( FIG. 3 ) of the coupling element 22 , as a result of which both the catch engagement with the complementary catch elements 8 and the anti-rotation engagement with the mating elements 25 are maintained in every axial position of the operating knob 27 . [0056] The dose setting and forward drive mechanism contains a second coupling due to the dose setting coupling formed by the coupling elements 16 and 22 , namely the dispensing coupling already mentioned above, which is illustrated in FIG. 6 . The dispensing coupling comprises the coupling elements 12 and 16 , which are provided with mating elements which engage with one another in the coupled engagement for this purpose. These are mating elements 15 a and 15 b on the side of the coupling element 12 . The coupling element 16 is provided with mating elements 21 . The mating elements 15 a are axial ribs which project radially outward from an internal surface of the coupling element 12 at the proximal end. The mating elements 21 are provided in the form of co-operating axially blind grooves on an internal surface at the proximal end of the coupling element 16 . The mating elements 21 form an axial guide for the mating elements 15 a . The mating elements 15 a constitute a sort of external teeth or toothing about the axis RT. The external teeth are interrupted at one point at least and, in the embodiment illustrated as an example, at two points lying diametrically opposite one another. Disposed in each interrupted circumferential region is one of the mating elements 15 b . Like the mating elements 15 a , the mating elements 15 b project radially outward but are wider than the mating elements 15 a in the circumferential direction so that they are not able to move into the mating elements 21 formed by blind grooves. Instead, the rib webs left between the mating elements 21 form an axial stop for the mating elements 15 b when the coupling element 12 is moved in the distal direction relative to the coupling element 16 . [0057] The coupling element 16 is moved selectively with the coupling element 22 or coupling element 12 in the coupled engagement, i.e. in the coupled engagement with the coupling element 22 when the dispensing coupling is released and in the coupled engagement with the coupling element 12 when the dose setting coupling is released. To set the dose, the dose setting coupling is closed, i.e. the mating elements 15 a and 15 b axially overlap only the coupling element 22 , the internal surface of which is circumferentially smooth so that the coupling element 22 is able to rotate relative to the coupling element 12 as the dose is being set. To dispense the set dose, the coupling element 12 moves into the coupled engagement with the dose setting and display element 16 , the dose setting coupling is released as a result and the dispensing coupling is closed so that the dispensing operation can start. FIG. 6 illustrates the coupling elements 12 , 16 and 22 in the state in which the dose setting coupling is closed. [0058] The user holds the injection device in one hand and places a cannula unit on the outlet 1 a and screws it tight with the other hand. Otherwise, the injection device is in the state illustrated in FIGS. 1 to 3 . Due to the windows 1 b and 2 b , the user is able to see how full the reservoir R is and check the position of the plunger 10 . It is assumed the reservoir has been primed and that the user would like to inject a specific dose of medicament in the next step. The desired dose is set by turning the operating knob 27 . During the setting operation, the user can take a reading of the dose corresponding to the axial position of the dose setting and display element 30 at any time through the window 4 . If a dose is accidentally set too high during the process of increasing the dose, the user can correct the overdose by turning the operating knob 27 in the correction direction. During the process of setting the dose, the rotating movement of the operating knob 27 is transmitted to the coupling element 22 via the extant anti-rotation lock at 25 and to the coupling element 16 via the closed dose setting coupling at 20 , 24 and to the dose setting and display element 30 in the guide engagement between 18 and 31 . With the threads 3 a and 30 a in the engaged state, the dose setting and display element 30 moves in rotation about the axis RT and in translation in the proximal direction. As the dose is being increased, the spring element 32 becomes increasingly elastically tensed and assists any dose correction which might be needed. Both when increasing the dose and also correcting the dose, the catch engagement of the slip coupling between the housing portion 3 and the operating knob 27 makes a clearly perceptible clicking noise. Due to the steepness of the threads 3 a and 30 a , the dose setting and display element 30 travels a correspondingly long displacement path in the axial direction. The distances between the dose marks of the dose scale of the dose setting and display element 30 are equally long in the axial direction, thereby providing a clear reading of the dose marks extending below the window 4 , even for users with a impaired sight. [0059] The plunger rod 11 is uncoupled from the dose setting movement which, in the embodiment illustrated as an example, is the dose rotating movement, and is additionally prevented from effecting any rotating movements due to the surrounding coupling element 12 , which is likewise uncoupled. As explained above, the lock established by the slip coupling produced between the coupling element 12 and retaining mechanism 2 a and the anti-rotation engagement of the coupling element 12 with the plunger rod 11 are maintained. [0060] When the desired dose has been set, the user pierces the desired injection site with the piercing cannula and moves it into the subcutaneous tissue below the skin. With the same hand which he is using to hold the injection device during piercing, he then triggers dispensing of the set dose. [0061] The operating knob 27 , which fulfils the function of a dose setting knob whilst the dose is being set, serves a dual function and is also the trigger knob. When the dose is being set, the dose setting and display element 30 is retained depending on the dose catch positions of the catch elements 28 and complementary catch elements 8 of the slip coupling, i.e. the slip coupling prevents the dose setting and display element 30 from being able to move under the action of the spring element 32 . For the dispensing operation, therefore, the coupling between the housing portion 3 and the dose setting and display element 30 established via the slip coupling at 8 , 28 must be released. This is done by releasing the dose setting coupling established at 20 , 24 , for which purpose the user presses the operating knob 27 in the distal direction with the thumb. When an appropriate pressing force is applied, the operating knob 27 moves relative to the housing portion 3 and coupling element 22 against the force of the spring 23 in the distal direction and during this movement pushes against the coupling element 12 . The coupling element 12 flexes axially inwards in the region of its integrated spring 13 so that its mating elements 15 a move into engagement with the mating elements 21 of the coupling element 16 preventing any rotation. In a transition phase of the axial movement, the dose setting coupling between the coupling element 22 and the coupling element 16 is still closed, whilst the coupled engagement of the dispensing coupling between the coupling element 12 and coupling element 16 is also already being established. As soon as the mating elements 15 b make contact with the axial stop of the coupling element 12 in the distal direction, however, continuing pressure on the operating knob 27 causes the coupling element 16 to move against the force of its spring 17 in the distal direction, and thus lift out of the coupled engagement with the coupling element 22 . [0062] As soon as the dose setting coupling has been released, the dose setting and display element 30 is screwed in the distal direction due to the elastic force of the spring element 32 . The rotating element of the movement effected by the dose setting and display element 30 is transmitted to the coupling element 16 in the coupled engagement between the guide 18 and mating element 31 . Since the dispensing coupling is closed, the coupling element 16 transmits the rotating movement to the coupling element 12 , which in turn is connected to the plunger rod 11 so as to rotate in unison with it, so that the plunger rod 11 rotates in the thread engagement with the retaining mechanism 2 a and pushes the plunger 10 in the forward drive direction V. The dispensing movement of the components involved in this operation is terminated when the dose setting and display element 30 makes contact with the shoulder 2 c . The stroke or axial element of the displacement path of the dose setting and display element 30 therefore determines the stroke of the plunger 10 and hence the dispensed dose. Due to the fact that the thread pitch of the threads 3 a and 30 a is bigger than the threads of the plunger rod 11 and retaining mechanism 2 a , the stroke of the dose setting and display element 30 is reduced to the stroke of the plunger 10 in accordance with the reduction ratio. During the dispensing movement, the slip coupling between the spring 14 and retaining mechanism 2 a generates a clearly perceptible clicking noise, providing an acoustic indication to the user that medicament is being dispensed. The dispensing operation can also be at least generally checked through the windows 1 b and 2 b on the basis of the axial position of the plunger 10 . [0063] When the dose is being set, the stop element 26 in the thread engagement with coupling element 22 likewise moves as a function of the set dose. When the quantity of medicament predefined by the maximum stroke of the stop element 26 has been totally administered, which will not be the case until after several injections if the reservoir R was completely full, the user replaces the empty reservoir R with a new, full reservoir R. To this end, she merely has to separate housing portion 1 from the proximal housing portion (made up of portions 2 , 3 ), insert the new reservoir R with the plunger 10 already accommodated in it and connect the front and rear housing portions to one another again. [0064] In the exemplary embodiment, all the springs with the exception of the force transmitting element 32 are an integral part of a respective coupling element comprising a coupling part and spring part. Alternatively, however, one or more springs may also be provided separately from the respective coupling element in a conventional manner in the form of steel springs. This being the case, springs 13 , 17 and 23 may just as easily be replaced by steel springs because they fulfil exclusively a spring function. To replace the spring 14 , a replacement spring and catch elements on the distal end of the coupling element 12 could be provided. [0065] As far as the disposition of the dose setting and display element 30 and spring element 32 is concerned, it should be pointed out that, instead of the dose setting and display element 30 , the spring element 32 may be disposed axially overlapping the reservoir R as an alternative, in which case it could be supported on a thrust bearing, for example the shoulder 2 c . If the fittings were reversed in this manner, the dose setting and display element 30 would be moved in the proximal direction until it made contact with a stop during the dispensing operation. In yet another alternative, the spring element 32 could be provided in the form of a tension spring, although a fitting incorporating a compression spring is more particularly preferred. Yet another alternative is described in German patent applications No. 10 2005 043 806.7 and 10 2005 043 807.5. As described in these applications, the spring element adapted to the slip coupling is provided in the form of a torsion spring. The older applications are incorporated herein by reference in connection with the adapted arrangement comprising the slip coupling and spring element. [0066] Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms and steps disclosed. The embodiments were chosen and described to provide the best illustration of the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention generally relates to treating sleep disorders, and more specifically relates to implant systems, devices and methods for treating patients suffering from obstructive sleep apnea. [0003] 2. Description of the Related Art [0004] Obstructive sleep apnea (OSA) is caused by a blockage of the airway, which usually occurs when the soft tissue in the throat collapses and closes during sleep. The blockage can occur in a portion of the pharyngeal lumen and may include obstructions formed by the collapse of the tongue against the posterior wall of the pharynx, the collapse of the lateral pharyngeal walls, and the combined collapse of the tongue with impingement of the soft palate, particularly the posterior portion of the soft palate including the uvula. During each apnea event, the brain briefly arouses the sufferer in order to initiate the resumption of breathing. This type of sleep, however, is extremely fragmented and of poor quality. [0005] According to the National Institutes of Health, OSA affects more than twelve million Americans. When left untreated, OSA may result in high blood pressure, cardiovascular disease, weight gain, impotency, headaches, memory problems, job impairment, and/or motor vehicle crashes. Despite the seriousness of OSA, a general lack of awareness among the public and healthcare professionals results in the vast majority of OSA sufferers remaining undiagnosed and untreated. [0006] There have been a number of efforts directed to treating OSA. For example, devices for electrically stimulating the soft palate to treat snoring and obstructive sleep apnea are disclosed in U.S. Pat. Nos. 5,284,161 and 5,792,067. These devices have had mixed results because they require patient adherence to a strict regimen of use, subject the patient to discomfort during sleep, and result in repeated arousal of the patient. [0007] Another treatment, commonly referred to as continuous positive airway pressure (CPAP), delivers air into a patient's airway through a specially designed nasal mask or pillow. The flow of air creates positive pressure when the patient inhales to keep the airway open. CPAP is considered by many to be an effective non-surgical treatment for the alleviation of snoring and obstructive sleep apnea, however, patients complain about discomfort caused by the mask and hoses, including bloating, nasal drying, and dry eyes. As a result, patient compliance for CPAP is only about 40%. [0008] Surgical treatments have also been used to treat OSA. One such treatment is referred to as uvulopalatopharyngoplasty, which involves removing about 2 cm of the trailing edge of the soft palate to reduce the soft palate's ability to flutter between the tongue and the pharyngeal wall. Another procedure uses a surgical laser to create scar tissue on the surface of the soft palate, which reduces the flexibility of the soft palate for reducing snoring and/or closing of the air passage. Yet another procedure, commonly referred to as cautery-assisted palatal stiffening operation (CAPSO), is an office-based procedure performed under local anesthesia whereby a midline strip of soft palate mucosa is removed, and the wound is allowed to heal for stiffening the flaccid palate. [0009] Surgical procedures such as those mentioned above continue to have problems. Specifically, the area of tissue that is surgically treated (i.e., removal of palatal tissue or scarring of palatal tissue) is often larger than is necessary to treat the patient's condition. In addition, the above-mentioned surgical procedures are often painful with extended, uncomfortable healing periods. For example, scar tissue on the soft palate may present a continuing irritant to the patient. Furthermore, the above procedures are not reversible in the event of adverse side effects. [0010] Another surgical procedure for treating OSA uses several braided PET cylinders that are implanted in tissue to make the tissues of the tongue or uvula more rigid and less prone to deflection. The Pillar™ Palatal Implant System sold by Restore Medical of St. Paul, Minn. consists of cylindrical-shaped elements of braided polyester filaments that are implanted in the soft palate for reducing the incidence of airway obstructions in patients suffering from mild to moderate OSA. Use of the Pillar device may result in adverse side effects, including extrusion of the cylindrical-shaped elements, infection, and patient discomfort. [0011] Another implant system, sold under the trademark REPOSE™ by InfluENT of Concord, N.H., uses a titanium bone screw that is inserted into the posterior aspect of the mandible at the floor of the mouth. A loop of suture is passed through the tongue base and attached to the mandibular bone screw. The Repose™ procedure achieves a suspension or hammock of the tongue base making it less likely for the base of the tongue to prolapse during sleep. Due to the high activity of the tongue during wakefulness, however, the suture component of this device may act as a “cheese cutter” to the tongue, causing device failure and requiring subsequent removal. [0012] Another effort for treating OSA involves creating an auxiliary airway for bypassing the clogged portion of the main airway. In one embodiment of commonly assigned U.S. patent application Ser. No. 12/182,402, filed Jul. 30, 2008, the disclosure of which is hereby incorporated by reference herein, an auxiliary airway is formed by implanting an elongated conduit beneath a pharyngeal wall of the pharynx. The elongated conduit has a proximal end in communication with a first region of the pharynx, a distal end in communication with a second region of the pharynx, and an intermediate section extending beneath the pharyngeal wall for bypassing an oropharynx region of the pharynx. [0013] Magnets have also been used for treating OSA. For example, in one embodiment of commonly assigned U.S. patent application Ser. No. 12/183,955, filed Jul. 31, 2008, the disclosure of which is hereby incorporated by reference herein, a magnetic implant includes a bone anchor, a first magnet coupled to the bone anchor, a tongue anchor, a second magnet coupled to the tongue anchor, and a support for aligning the first and second magnets so that a repelling force is generated between the magnets for urging the second magnet away from the first magnet and toward the bone anchor. The support maintains the first magnet at a fixed distance from the bone anchor, aligns the first magnet with the second magnet, and guides movement of the first and second magnets. The magnetic implant disclosed in one or more embodiments of the '955 application does not have a hard stop so as to avoid the “cheese-cutter” effect observed when using implants having a hard stop. [0014] In spite of the above advances, there remains a need for additional systems, devices and methods for treating OSA through minimally invasive approaches that provide long term results, that encourage patient compliance, and that minimize patient discomfort. SUMMARY OF THE INVENTION [0015] In one embodiment, the present invention provides a medical implant for the treatment of obstructive sleep apnea including an implant device, such as an elastic extension member, affixed to the distal end of the hard palate and extending into the uvula. The implant device is adapted to provide a degree of support that is sufficient to resist distal movement of the tongue when the tongue is relaxed and the patient is in a supine position, but not so great as to impair the soft palate and the uvula from sealing the nasal cavity during the act of swallowing. In one embodiment, two or more implant devices are implanted in the soft palate, and the proximal ends of at least two of the devices are connected with the hard palate. [0016] In one embodiment, a system for treating obstructive sleep apnea includes a body implantable in a soft palate, and a fastening element at a proximal end of the body for connecting the body with a hard palate. In one embodiment, the body is curved and has a convex top surface and a concave bottom surface. The radius of the curve and the size of the body may vary depending upon the needs of the patient. When implanted, the convex top surface of the body preferably faces toward an upper end of a patient and the concave bottom surface of the body preferably faces toward the lower end of the patient. In one embodiment, the implant extends to the uvula for changing the shape of the uvula and/or providing support for the uvula. [0017] In one embodiment, the fastening element at the proximal end of the body is engageable with the hard palate for securing the body to the hard palate. In one embodiment, the fastening element desirably includes at least one barb adapted to engage the hard palate for anchoring the body to the hard palate. In one embodiment, the fastening element includes at least one tab projecting from the proximal end of the body and at least one barb projecting from the at least one tab. In one embodiment, an implantable body includes an upper tab, and a pair of opposing lower tabs that are normally biased toward one another. The opposing tabs preferably include inwardly projecting barbs that oppose one another. Upon implantation, the upper tab preferably overlies a top surface of the hard palate and the pair of lower tabs preferably underlie a bottom surface of the hard palate. The tabs bias toward one another so that the barbs on the respective tabs bite into the bone of the hard palate for securing the implant to the hard palate. [0018] In one embodiment, the body has a surface adapted to promote tissue in-growth. The tissue in-growth promoting surface is desirably selected from a group of outer surfaces including a textured surface, a porous surface, a braided surface, a mesh surface, a fleece surface, and a coating for inducing bone or tissue in-growth. In one embodiment, the body is made of materials such as nitinol, stainless steel, biocompatible polymers, temperature-sensitive materials, and/or shape memory materials. [0019] In one embodiment, an implant for supporting a uvula for treating obstructive sleep apnea includes a body implantable in a soft palate, the body having a distal end and a proximal end, and a fastening element adjacent the proximal end of the body for fastening the body to a hard palate. In one embodiment, the fastening element desirably includes at least one anchoring tab adapted to overlie the surface of a hard palate, the at least one anchoring tab having at least one barb. In one embodiment, the fastening element may include fasteners such as barbs, bone anchors, screws, tacks, pins, wire, sutures, staples, rods, and/or adhesive. [0020] In one embodiment, a method of treating obstructive sleep apnea includes forming a surgical opening in a soft palate, inserting an implant device through the surgical opening and into the soft palate, and securing the implant device to a hard palate. A distal end of the implanted device desirably engages the uvula for supporting and/or changing the shape of the uvula. In one embodiment, the shape of the soft palate is changed by the implant as the implant device is inserted into the soft palate. The method may include using a fastening element for securing the implant to the hard palate. The implant may include a body, and the fastening element for securing the body to the hard palate. The body may be curved, and the soft palate may be curved by the curved body during the inserting step. The fastening element preferably includes opposing tabs projecting from the proximal end thereof, whereby the opposing tabs are normally biased toward one another. In one embodiment, the opposing tabs include tissue engaging barbs. In one embodiment, the implant device may be implanted directly within the oral cavity of a patient. In one embodiment, the implant device may be implanted through the nasal passageway. [0021] In one embodiment, the implant devices disclosed herein may be used to re-shape the soft palate for minimizing the likelihood of obstructive sleep apnea episodes associated with long, flat soft palates and/or L-shaped soft palates. In one embodiment, when a long, flat soft palate is causing OSA, an implant having a curved body may be implanted into the soft palate for increasing the curve of the soft palate. In another embodiment, when an L-shaped soft palate is causing OSA, an implant may be inserted for reducing the curve or angle of the soft palate. Thus, in one embodiment, a plurality of implants having varying radii may be provided, whereby an implant having a desired amount of curve may be utilized for increasing or reducing the curve of the soft palate (i.e. changing the shape of the soft palate). In one embodiment, a plurality of implants having varying sizes may be provided so as to enable medical personnel to select an implant having a desired size. [0022] In one embodiment, the implant device is made of a shape changeable material such as nitinol. The nitinol may have a super elastic property and/or a shape memory property. In the one embodiment whereby the nitinol has a shape memory property, the nitinol material has a first transition temperature set just above body temperature, whereby the nitinol transitions into a pre-determined elastic configuration to support the uvula and thereby keep the airway open. In this state, the implant may be useful during sleep. The implant desirably includes a second lower transition temperature set somewhat below body temperature, whereby the implant transitions into a ductile state allowing the uvula move in a posterior direction. This state or condition may be suitable for when the patient is awake, whereupon there is no need for the implant to urge the uvula into a more anterior position. An implant having shape memory properties may be used in other areas of the airway. In one embodiment, a transition into the ductile state may be initiated by gargling with cold water. In one embodiment, a transition into a pre-determined elastic state may be achieved by drinking warm or hot fluid. [0023] In one embodiment, an implant device made of a shape memory material, such as nitinol, may be implanted when at a temperature that is below body temperature. When below the normal body temperature, the material is easily shapeable. After implantation, the material may be elevated to body temperature, whereby the implant assumes its pre-determined shape to support the uvula. In certain preferred embodiments, the implant device is made of stainless steel, such as 300 and 400 series stainless steel. The implant device may also be made of a biocompatible polymer. [0024] In one embodiment, the degree of support provided by the implant may be customized by adjusting the length of the implant, such as by trimming the implant. The cross-sectional geometry of the implant may also be changed to reduce or increase the section modulus. [0025] The outer surface of the implant device may be modified to encourage tissue in-growth so as to stabilize the implant within tissue and minimize opportunity for tissue erosion. Modification of the outer surface to promote tissue in-growth may be achieved by texturizing the outer surface, making the implant porous through the addition of openings or apertures, encapsulating the implant with a braided structure, surgical mesh, or fleece type material, and/or at least partially coating the implant with bone growth stimulating agents such as hydroxyapatite. [0026] Although the present is not limited by any particular theory of operation, it is believed that providing an implant device that supports the uvula and that is connected to the distal end of the hard palate provides more positive positioning of the uvula and enables the uvula to provide greater resistance to distal tongue movement than implants that are not supported by the hard palate. The implant also provides a balanced level of uvula support which provides tongue support when needed, but does not inhibit swallowing. The shape changing feature preferably allows greater uvula support (and thereby tongue support) during times of rest, and less support during waking hours. The modification of the outer surface of the implant preferably reduces the chance of tissue erosion and provides greater lateral stability to the implant. The ability to implant the device through the nasal passageway results in an implant being more cranial and thereby minimizing the tongue's sensitivity to the implants' presence. Furthermore, the implant device disclosed herein provides a medical procedure that does not damage the musculature within the soft palate and maintains all mucosal surfaces, which enables the natural musculature to continue providing support in addition to that provided by the implant. [0027] These and other preferred embodiments of the present invention will be described in more detail below. BRIEF DESCRIPTION OF THE DRAWING [0028] FIG. 1 shows a cross-sectional view of a human head including a nasal cavity and a pharynx. [0029] FIG. 2 shows a cross-sectional view of the nasal cavity and the pharynx of a human during normal breathing. [0030] FIG. 3 shows a cross-sectional view of the nasal cavity and the pharynx of a human during an obstructive sleep apnea episode. [0031] FIG. 4 shows another cross-sectional view of the nasal cavity and the pharynx of a human during an obstructive sleep apnea episode. [0032] FIGS. 5A-5E show a perspective view of an implant used for treating obstructive sleep apnea, in accordance with one embodiment of the present invention. [0033] FIG. 6 shows a distal end of an insertion tool for inserting the implant shown in FIGS. 5A-5E , in accordance with one embodiment of the present invention. [0034] FIGS. 7A-7D show the implant of FIGS. 5A-5E secured to the distal end of the insertion tool of FIG. 6 , in accordance with one embodiment of the present invention. [0035] FIG. 8A shows a cross-sectional view of the implant insertion tool of FIGS. 7A-7D with the insertion tool in a first position, in accordance with on embodiment of the present invention. [0036] FIG. 8B shows a cross-sectional view of the implant insertion tool of FIGS. 7A-7D with the insertion tool in a second position, in accordance with one embodiment of the present invention. [0037] FIG. 9A shows a method of inserting the implant of FIGS. 5A-5D in a patient using the insertion tool shown in FIGS. 6 and 7 A- 7 D, in accordance with one embodiment of the present invention. [0038] FIG. 9B shows a magnified view of the implant and the distal end of the insertion tool shown in FIG. 9A . [0039] FIGS. 10A-10C show a method of inserting an implant device in a patient using an insertion tool, in accordance with one embodiment of the present invention. [0040] FIGS. 10A-1 , 10 B- 1 and 10 C- 1 show a magnified view of the insertion method shown in FIGS. 10A-10C . [0041] FIGS. 11A and 11B show a method of treating obstructive sleep apnea, in accordance with one embodiment of the invention. [0042] FIG. 12 shows an implant for treating obstructive sleep apnea, in accordance with one embodiment of the present invention. [0043] FIG. 13 shows an implant for treating obstructive sleep apnea, in accordance with one embodiment of the present invention. [0044] FIG. 14 shows a system for treating obstructive sleep apnea, in accordance with one embodiment of the present invention. [0045] FIG. 15 shows a system for treating obstructive sleep apnea, in accordance with one embodiment of the present invention. DETAILED DESCRIPTION [0046] FIG. 1 shows a cross-section of a human head with anatomical structures including the nasal cavity N, bone B of the hard palate HP, the soft palate SP including the uvula UV at the posterior end thereof, the mouth M, the tongue T, the trachea TR, the epiglottis EP, the esophagus ES, and the posterior pharyngeal wall PPW. [0047] In a human body, an air filled space between the nasal cavity N and the larynx LX is referred to as the upper airway. The most critical part of the upper airway associated with sleep disorders is the pharynx PX. Referring to FIG. 2 , the pharynx has three different anatomical levels. The nasopharynx NP is the upper portion of the pharynx located in the back of the nasal cavity N. The oropharynx OP is the intermediate portion of the pharynx containing the soft palate SP, the epiglottis EP, and the curve at the back of the tongue T. The hypopharynx HP is the lower portion of the pharynx located below the soft tissue of the oropharynx OP. The oropharynx OP is the section of the pharynx that is most likely to collapse due to the high prevalence of soft tissue structure, which leaves less space for airflow. The hypopharynx HP lies below the aperture of the larynx and behind the larynx, and extends to the esophagus. [0048] As is well known to those skilled in the art, the soft palate and the tongue are both flexible structures. The soft palate SP provides a barrier between the nasal cavity N and the mouth M. In many instances, the soft palate SP is longer than is necessary and extends a significant distance between the back of the tongue T and the posterior pharyngeal wall PPW. The midline posterior end of the soft palate is referred to as the uvula, which is the soft tissue that extends downward from the soft palate over the back of the tongue. [0049] Although the muscles relax throughout the body during sleep, most of the muscles of the respiratory system remain active. During inhalation, the diaphragm contracts and causes negative pressure to draw air A into the nasal cavity N and the mouth M. The air then flows past the pharynx PX, through the trachea TR and into the lungs. The negative pressure causes the tissue of the upper airway to deform slightly, which narrows the airway passage. In apneic patients, the soft palate SP, the tongue T, and/or the epiglottis EP collapse against the posterior pharyngeal wall PPW to block airflow into the trachea. As the airway narrows, airflow through the pharynx becomes turbulent, which causes the soft palate SP to vibrate, generating a sound commonly known as snoring. [0050] During sleep, humans typically experience brief obstructions of airflow and/or small decreases in the amount of airflow into the trachea and lungs. An obstruction of airflow for more than ten seconds is referred to as apnea. A decrease in airflow by more than fifty percent is referred to as hypopnea. The severity of sleep disorders is measured by the number of apneas and hypopneas that occur during every hour of sleep. [0051] If apnea or hypopnea occurs more than five times per hour, most medical personnel diagnose the individual as having an upper airway resistance problem. Many of these patients often exhibit symptoms related to sleep disorders including sleepiness during the day, depression, and difficulty concentrating. [0052] Individuals having ten or more episodes of apnea or hypopnea during every hour of sleep are officially classified as having obstructive sleep apnea syndrome. As the airway is obstructed, the individual makes repeated attempts to force inhalation. Many of these episodes are silent and are characterized by movements of the abdomen and chest wall as the individual strains to draw air into the lungs. Typically, episodes of apnea may last a minute or more. During this time, oxygen levels in the blood will decrease. Ultimately, the obstruction may be overcome by the individual generating a loud snore or awakening with a choking feeling. [0053] Referring to FIG. 2 , when an individual is awake, the back of the tongue T and the soft palate SP maintain their shape and tone due to their respective internal muscles. As a result, the airway A through the pharynx remains open and unobstructed. During sleep, however, the muscle tone decreases and the posterior surface of the tongue and the soft palate become more flexible and distensible. [0054] Referring to FIG. 3 , without normal muscle tone to keep their shape and to keep them in place either alone or as a group, the posterior surface of the tongue T, the epiglottis EP, and the soft palate SP tend to easily collapse to block the airway A. [0055] Referring to FIG. 4 , during sleep, the proximal end of the tongue T may block the airway A between the nasal passages N and the upper end of the trachea TR. The soft palate SP may also relax and have the uvula UV slide between the back of the tongue T and the posterior pharyngeal wall PPW. In one embodiment, the present invention provides an implant that changes the shape of the soft palate so that it does not move into the position shown in FIG. 4 . The implant also desirably provides support to the tongue T so that it does not sag in a posterior direction against the posterior pharyngeal wall, as shown in FIG. 4 . [0056] Referring to FIGS. 5A-5E , in one embodiment, an implant 100 , such as a soft palate implant, includes a main body 102 that is implantable in a soft palate. The main body 102 has a posterior or distal end 104 , and an anterior or proximal end 106 that is adapted to be coupled and/or secured to a hard palate of a patient. The main body 106 of the implant 102 preferably includes a top surface 108 and a bottom surface 110 . The main body 102 of the implant 100 preferably has a length L and a width W that may vary depending upon patient anatomy. The main body 102 and the top and bottom surfaces 108 , 110 may be curved. The curvature of the main body 102 may vary depending upon patient anatomy, the specific problem affecting the patient and/or surgical requirements. In one embodiment, the curvature of the main body 102 may be varied as required to prevent the back of a patient's tongue from pressing against the posterior pharyngeal wall. [0057] Referring to FIGS. 5A-5E , in one embodiment, the proximal end 106 of the soft palate implant 102 includes a securing element 112 for securing the implant to a hard palate of a patient. In one embodiment, the securing element includes an upper anchoring tab 114 adapted to engage an upper surface of a hard palate, and a pair of lower anchoring tabs 116 , 118 adapted to engage a lower surface of a hard palate. [0058] Referring to FIGS. 5A and 5E , in one embodiment, the upper anchoring tab 114 desirably includes a leading end 120 and trailing end 122 that is connected to the main body 102 via a flexible connection 124 . The upper anchoring tab 114 includes an outer face 126 and an inner face 128 having anchoring barbs 130 . The anchoring barbs 130 are adapted to bite into an upper surface of a hard palate for anchoring the proximal end 106 of the soft palate implant 100 to the hard palate. The flexible connection 124 normally biases the upper anchoring tab 114 toward the opposing lower anchoring tabs 116 , 118 in a downward direction designated D 1 . [0059] The lower anchoring tabs include the first lower tab 116 having a leading end 132 and a trailing end 134 that is connected with the main body 102 via a flexible connection 136 . The flexible connection 136 normally biases the first lower tab 116 toward the upper tab 114 in an upward direction designated D 2 . The first lower tab 116 includes an outer surface 138 and an inner surface 140 having anchoring barbs 142 projecting therefrom. In one embodiment, the anchoring barbs 142 are adapted to bite into an underside surface of a hard palate. The first lower tab 116 also desirably includes through holes 144 that extend from the inner surface 140 toward the outer surface 138 . In one embodiment, the through holes 144 extend completely between the inner and outer surfaces 140 , 138 . In one embodiment, the through holes 144 are blind detents that extend only part of the way between the inner surface and the outer surface. [0060] The second lower tab 118 preferably includes a leading end 146 and a trailing end 148 that is coupled with a proximal end of the main body via a flexible connection 150 . The flexible connection 150 normally biases the second lower tab 118 toward the upper anchoring tab 114 in an upward direction designated D 2 . The second lower anchoring tab 118 includes an outer surface 152 and an inner surface 154 having bone anchoring barbs 156 projecting therefrom. The bone anchoring barbs 156 are preferably adapted to bite into an underside surface of a hard palate. The second lower anchoring tab 118 also includes through holes 158 adapted to receive posts at a distal end of an insertion tool as will be described in more detail below. [0061] Referring to FIG. 6 , in one embodiment, an insertion tool 200 for implanting the implant 100 shown in FIGS. 5A-5E includes a shaft 202 having a distal end 204 that secures and deploys the implant. The distal end 204 of the insertion tool 200 desirably includes an upper blade 210 having a leading end 212 and a trailing end 214 . The upper blade 210 includes a pair of aligned slits 216 A, 216 B that extend from the leading end 212 toward the trailing end 214 . The upper blade 210 includes a first set of through holes 218 A, 218 B adjacent the first slot 216 A, and a second set of through holes 220 A, 220 B adjacent the second slot 216 B. [0062] Referring to FIG. 6 , in one embodiment, the insertion tool 200 also preferably includes a lower blade 222 having a leading end 224 and a trailing end 226 . The lower blade 222 includes an inner surface 228 having a first set of lower anchoring tab securing posts 230 aligned with one another and extending along a first lateral edge 232 of the lower blade 222 and a second set of lower anchoring tab securing posts 234 aligned with one another and extending along a second lateral edge 236 of the lower blade 222 . In one embodiment, the aligned securing posts 230 , 234 on the lower blade 222 may be aligned with the through holes 218 , 220 extending through the upper blade 212 . [0063] In one embodiment, the lower blade 222 is adapted to be wedged away from the upper blade 210 for releasing the uvula implant from the distal end 204 of the insertion tool. In one embodiment, the insertion tool 200 includes a push bar 240 that is coupled with an actuator (not shown) located at a proximal end of the insertion tool. Upon activation of the actuator (not shown), the push bar 240 preferably moves in a distal direction designated D 3 for wedging the leading end 224 of the lower blade 222 away from the upper blade 210 . In one embodiment, the push bar may wedge the upper blade away from the lower blade. [0064] Referring to FIGS. 7A-7D , in one embodiment, the soft palate implant 100 is preferably securable to the distal end 204 of the insertion tool 200 . Referring to FIGS. 7A-7D , in one embodiment, the insertion tool 200 includes an elongated shaft 202 having a distal end 204 and a proximal end 206 coupled with a housing 207 having an actuator or trigger 209 . Referring to FIGS. 7C and 7D , in one embodiment, the lower anchoring tabs 116 , 118 are held between the upper blade 210 and the lower blade 222 , with the barbs 142 projecting from the inner surfaces of the lower tabs 116 , 118 passing through the slots 216 adjacent the lateral edges of the upper blade 210 . In one embodiment, the upper and lower blades 220 , 222 pinch towards one another for holding the lower anchoring tabs 116 , 118 therebetween. The securing posts 234 on the lower blade 222 preferably pass through the through holes 144 , 158 of the lower anchoring tabs 116 , 118 for more securely holding the implant to the distal end 204 of the insertion tool 200 . [0065] Referring to FIGS. 7C and 7D , in one embodiment, when the lower anchoring tabs 116 , 118 are held between the upper and lower blades 210 , 224 , the upper anchoring tab 114 preferably lies above the upper blade 210 . In one embodiment, during an insertion operation, the insertion tool 200 secures the implant 100 so that the distal end 104 of the implant 100 may be guided into a surgical opening, such as an incision formed in the soft palate of a patient. In one embodiment, the push bar 240 is actuated so that it moves in the direction D 3 toward the distal end of the insertion tool 200 . As the push bar 240 moves toward the distal end, the upper and lower blades 210 , 222 are wedged away from one another for releasing the lower anchoring tabs 116 , 118 from the insertion tool. In one embodiment, the respective upper and lower anchoring tabs will preferably bias toward one another, whereby the barbs on the inner surfaces of the tabs bite into the respective upper and lower faces of the hard palate for anchoring the implant 100 to the hard palate. [0066] Referring to FIGS. 8A and 8B , in one embodiment, the distal end of the insertion tool 200 is adapted to secure a proximal end of the implant device 100 . The distal end of the insertion tool preferably releases the implant device after the device has been implanted in tissue. In one preferred embodiment, the insertion tool is used to implant the implant device in the soft palate of a patient and anchor a proximal end of the implant device to the patient's hard palate. [0067] Referring to FIG. 8A , in one embodiment, the upper and lower blades pinch the pair of lower tabs 116 , 118 therebetween, and the push bar 240 is in a retracted position. In FIG. 8B , the push bar 240 is advanced in a distal direction designated D 3 for wedging the lower blade 222 away from the upper blade 210 so as to release the pair of lower tabs 116 , 118 from the distal end of the insertion tool 200 . The insertion tool may then be retracted in the direction designated D 4 so as to release the implant device 100 and leave the proximal end of the implant device anchored to a structure, such as the hard palate of a patient. [0068] Referring to FIG. 9A , in one embodiment, a surgical opening SO is formed in the soft palate SP and an implant device 100 is inserted into the surgical opening for supporting the soft palate SP and the uvula UV. In one embodiment, the implant 100 is preferably held by the upper and lower blades at the distal end 204 of the insertion tool 200 . FIG. 9B shows a magnified view of the distal end 204 of the insertion tool 200 with the implant 100 inserted into the surgical opening SO in the soft palate SP. In one embodiment, the shaft 202 of the insertion tool 200 is moved in the direction A 1 for inserting the implant 100 into the surgical opening SO. The shaft 202 of the insertion tool 200 is then retracted in the direction A 2 so that the upper tab 114 overlies the top surface of the hard palate HP and the lower tabs 116 , 118 underlie the bottom surface of the hard palate. The push bar is then advanced to open the upper and lower blades of the tool for releasing the implant 100 from the distal end of the insertion tool. [0069] FIGS. 10A-10C and 10 A- 1 through 10 C- 1 show a simplified view of how the insertion tool is used for implanting the implant device in the soft palate. Referring to FIG. 10A , after the soft palate implant 100 has been inserted into the surgical opening in the soft palate and while the upper and lower blades 210 , 222 hold the implant 100 , the insertion tool 200 is moved in a the direction A 2 so that the upper anchoring tab 114 overlies the top surface of the hard palate HP and the lower anchoring tabs 116 , 118 are positioned under the bottom surface of the hard palate HP. [0070] FIG. 10A-1 shows a magnified cross-sectional view of the soft palate implant 100 and the insertion tool 200 shown in FIG. 10A . The implant 100 includes the upper anchoring tab 114 overlying a top surface of the hard palate HP and the lower anchoring tabs 116 , 118 underlying the bottom surface of the hard palate HP. Initially, the lower anchoring tabs 116 , 118 remain secured between the upper blade 210 and the lower blade 222 of the insertion tool. The upper and lower blades 210 , 222 desirably pinch the lower anchoring tabs 116 , 118 therebetween for securing the lower tabs to the distal end of the insertion tool. The push bar 240 , which is later used for wedging the lower blade 222 away from the upper blade 210 , is preferably in the fully retracted position. [0071] Referring to FIG. 10B , in one embodiment, an actuator at the proximal end of the insertion tool 200 is engaged for moving the push bar 240 in a distal direction designated D 3 . As the push bar 240 moves in the distal direction, the lower blade 224 is wedged away from the upper blade 210 so that the securing posts 234 on the lower blade 222 are retracted from the through holes extending through the lower anchoring tabs 116 , 118 . [0072] FIG. 10B-1 shows an expanded view of FIG. 10B , whereby the lower blade 222 of the insertion tool 200 is wedged away from the upper blade 210 by the push bar 240 . The posts 234 on the lower blade 222 are retracted from the through holes in the lower anchoring tabs 116 , 118 of the implant 100 . The barbs on the pair of lower anchoring tabs 116 , 118 preferably pass through the slots in the upper blade for engaging the underside of the hard palate HP. After the upper and lower blades 210 , 222 have been wedged away from one another for releasing the implant 100 , the insertion tool 200 may be retracted in the direction designated A 2 . After being released from the distal end of the insertion tool, the upper and lowers tabs of the implant 100 preferably bias toward one another for pinching the hard palate HP therebetween. The barbs 130 , 142 on the inner surfaces of the opposing upper and lower anchoring tabs 114 , 116 , 118 preferably bite into the bone of the hard palate HP for anchoring the implant 100 to the hard palate HP. [0073] FIGS. 10 C and 10 C- 1 show the implant 100 after it has been anchored to the hard palate HP. The implant 100 includes the upper tab 114 anchored to the top surface of the hard palate HP, and the lower tabs 116 , 118 anchored to the underside surface of the hard palate HP. As shown in FIG. 10C-1 , the barbs 124 on the upper anchoring tab 114 bite into the upper surface of the hard palate HP, while the barbs 142 on the lower anchoring tabs 116 , 118 bite into the underside surface of the hard palate HP. Although barbs are shown for securing the implant to the hard palate, in other embodiments other fastening elements such as screws, pins, tacks, adhesives, wire, and sutures may be used for securing the implant to the hard palate. [0074] Referring to FIG. 11A , some patients have a condition whereby the soft palate SP has a horizontal component H and a vertical component V that is angled relative to the horizontal component. In some instances, the vertical component V may be at an angle that approaches 90° or more relative to the horizontal component H. As is known to those skilled in the art, the existence of the vertical component reduces the size of the opening in the posterior portion of the nasopharynx, which may cause OSA symptoms. In order to change the shape of the soft palate SP and/or provide a soft palate SP having a more continuous arc, an implant as disclosed herein may be implanted into the soft palate of a patient. FIG. 11B shows the soft palate SP of the FIG. 11A after the implant 100 has been implanted therein. The implant 100 includes a proximal end anchored to the hard palate HP of the patient and a distal end that extends to the uvula UV. The implant 100 preferably changes the shape of the soft palate so that it has a more preferred, continuous arc between the hard palate HP and uvula UV. The more continuous arc shape of the soft palate shown in FIG. 11B opens the posterior portion of the nasopharynx and provides more space between the soft palate SP and the posterior pharyngeal wall PPW. During sleep, the implanted device 100 may provide indirect support to the tongue T in an anterior direction for further opening in the posterior portion of the nasopharynx. [0075] Referring to FIG. 12 , in one embodiment, an implant 300 for supporting and/or changing the shape of the uvula includes a main body 302 and a fastening element provided at a proximal end of the main body. The main body includes a plurality of openings 305 extending therethrough that provide for bone or tissue in-growth. FIG. 13 shows another embodiment of an implant 400 for supporting a uvula including a main body 402 having an outer mesh surface 405 for promoting bone and/or tissue in-growth. [0076] Although the present invention is not limited by any particular theory of operation, it is contemplated that two or more implant devices may be implanted in a soft palate of a patient for supporting and/or changing the shape of the uvula of the patient for treating obstructive sleep apnea. Referring to FIG. 14 , in one embodiment, a system for treating obstructive sleep apnea may include a pair of implant devices 500 A and 500 B implanted in a soft palate SP, whereby each of the implants have distal ends supporting a uvula and proximal ends anchored to a hard palate. Referring to FIG. 15 , in one embodiment, a system for treating obstructive sleep apnea may include a plurality of implant devices 600 A, 600 B, 600 C (e.g. three implant devices) that are implanted in a soft palate SP, whereby each of the implants have distal ends supporting a uvula and proximal ends anchored to a hard palate HP. The implants extending through the soft palate may be parallel to one another or may be angled relative to one another. The lengths and/or sizes of the implants may vary. In one embodiment, a first implant may have a first length, and a second adjacent implant may have a second length that is different than the first length. [0077] In other embodiments, fastening elements other than barbs may be used for securing the proximal end of the implant to the hard palate. In one embodiment, one or more screws may be used for securing the implant to a hard palate. In another embodiment, surgical tacks may be used for securing the implant to the hard palate. In yet another embodiment, surgical wire or sutures may be used to securing the implant to the hard palate. Bone needles may also be used for securing the implant to the hard palate. [0078] In one embodiment, the implant may have an outer surface that encourages tissue in-growth so as to stabilize the implant within the tissue and so as to minimize the opportunity for tissue erosion. The outer surface modification may be achieved by texturizing the outer surface, making the implant porous through the addition of holes (e.g. drilled or pierced holes), encapsulating the implant with a braided, surgical mesh, or fleece type material, and/or coating the implant with bone growth stimulating agents such as hydroxyapatite. [0079] Although the present invention is not limited by any particular theory of operation, it is believed that providing a soft tissue implant supported by the distal end of the hard palate provides more positive positioning of the uvula and enables the uvula to provide greater resistance to distal tongue movement than when using implants that are not supported by the hard palate. The soft palate implant of the present invention preferably provides a balanced level of support for the uvula, providing tongue support when needed, but not inhibiting swallowing. The shape changing feature of the implant allows greater uvula support (and thereby tongue support) during times of rest and less support during waking hours. Providing an outer surface on the implant having tissue in-growth capabilities reduces the chance of tissue erosion and provides greater lateral stability to the implant. In one embodiment, the ability to implant the device through the nasal passageways results in the implant location being more cranial, thereby minimizing tongue sensitivity to the presence of the implant. In one embodiment, the implant procedure does not damage the musculature within the soft palate and maintains mucosal surfaces, thereby enabling the natural musculature to continue to provide support in addition to that provided by the implant. [0080] In one embodiment, the soft palate implant may be formed from absorbable materials, non-absorbable materials, or a combination of absorbable and non-absorbable materials. The non-absorbable materials may include polymeric materials such as non-resorbable polymers, silicone, polyethylene terephalate, polytetrafluoroethylene, polyurethane and polypropylene, nitninol, stainless steel, and/or composite materials. Suitable resorbable polymers may include polylactide, polyglycolide copolymers, polycaprolactone, and/or collagen. The implant may also include a biocompatible metal or alloy. [0081] The present invention provides a number of advantages over prior art methods and devices used for treating obstructive sleep apnea syndrome and hypopnea. First, the methods, systems and devices disclosed herein provide for simple surgical procedures that are minimally invasive. Typically, the methods, systems and devices disclosed herein may be utilized during an outpatient procedure. In addition, the methods, systems and devices disclosed herein provide both immediate and long term results for treating obstructive sleep apnea syndrome and hypopnea. Moreover, the methods, systems and devices disclosed herein do not require a significant level of patient compliance. [0082] In addition, the present invention does not anchor the tongue to a fixed hard structure, such as the mandible. Thus, the present invention is significantly less likely to affect swallowing or speech, thereby providing a great improvement over prior art devices, systems and methods. The present invention also preferably uses materials having long-term biocompatibility. [0083] Although various embodiments disclosed herein relate to use in humans, it is contemplated that the present invention may be used in all mammals, and in all animals having air passages. Moreover, the methods, systems and devices disclosed herein may incorporate any materials that are biocompatible, as well as any solutions or components that minimize rejection, enhance tissue ingrowth, enhance the formation of mucosal layers, and improve acceptance of the device by a body after the device has been implanted. [0084] The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures. [0085] While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. As such, the scope of the present invention is to be limited only as set forth in the appended claims.

1a

BACKGROUND OF THE INVENTION This invention relates to means for the atomizing of cosmetic products, in particular hair lacquer. The use of so-called spray bombs for the application of hair lacquers is well known, with the lacquer being expelled in atomized form by means of a halofluorocarbon propellant gas contained within the bomb. It has now been ascertained that the use of such propellant gases may be harmful to the health and that it would be advisable to abandon the atomizing of hair lacquers and similar cosmetic products by means of propellant gases, for example, chlorofluorocarbide, chlorodifluoromethane and mixtures of chlorodifluoromethane and tetrafluorodifluoroethane. A further drawback of the said spray bombs consists in their rather high cost of manufacture. SUMMARY OF THE INVENTION It is the object of this invention to remove the above-mentioned drawbacks by allowing the atomizing of hair lacquers without the use of halofluorocarbon propellant gases and appurtenant spray bombs. This object is attained according to this invention by using at least one bomb, to be filled with the lacquer to be atomized and provided in a head part with a controllable valve and an atomizing nozzle unit, said container being connected by a suitable hose to means for generating compressed air. In a preferred advantageous embodiment, more than one bomb can be removably arranged in seats provided in a housing body, with the compressed-air generating means, for example a small piston compressor, seated in the rear part of the said housing body. The arrangement according to this invention will now be described more in detail with respect to a preferred embodiment thereof given by way of example without being limited thereto and is shown in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view of a housing body having two bombs; FIG. 2 is a side view of the housing body according to FIG. 1, with one bomb lifted out, along with its compressed-air supply hose; FIG. 3 shows the connection between the compressor and the two bombs for the atomizing of hair lacquer; FIG. 4 is a cross-section of a detail showing the compressed-air check valve; FIG. 5 shows a side view of a removable atomizing nozzle. DESCRIPTION OF THE PREFERRED EMBODIMENTS As shown in FIG. 1, one or more bombs 1 are arranged with their lower part 4 inserted into a suitable seat 2 of a housing body 3. Each lower part 4 of the relative bomb 1 is designed to receive the lacquer to be atomized. For example, part 4 may be screwed to a head part 5 containing the atomizing mechanism to be described hereinafter. FIG. 2 shows the bombs 1 seated in the seats 2 provided in the front part of the housing body 3. The said housing body 3 has in its rear part a bay 6 suitably designed for receiving a means for the generation of a compressed-air flow, for example a piston compressor (not shown). The outflow side of the compressor is connected by means of a suitable hose 7 to the atomizing head 5 (FIG. 4). The atomizing head 5 comprises a union 8 for connecting the corresponding hose 7. Same union leads to a valve 14 which is controlled by a flat movable cover 9 part of the atomizing head 5. When exerting a pressure on the cover 9 in direction of the arrow f (FIG. 2), the valve 14 will be opened allowing the compressed air to flow from the hose 7 toward the removable spraying nozzle unit 10 and allowing at the same time the lacquer to be expelled in the form of an atomized veil 11. For the purpose, the valve body is provided with a peripheral groove 14a open on the outside. Advantageously, the hoses 7 surround the corresponding bomb 1 in form of a spiral, allowing the easy extraction of the bomb 1 from its corresponding seat 2 or vice versa, the reseating of the bomb 1 together with its hose 7 into the seat 2. FIG. 3 schematically illustrates the compressed-air supply circuit leading to the atomising head 5 of the two bombs 1. From a source of compressed air, for example a compressor 12, a supply hose 13 leads to a `Y`-ramification 13a, whose ramification branches are connected to the flexible hoses 7 leading toward the corresponding atomizing heads 5. Advantageously, the ramification 13a is incorporated within the housing body 3, with only the unions for the connection of the hoses 7 being left free (FIG. 4). FIG. 4 shows a cross-sectional detail of the atomizing head 5, in particular the compressed-air flow check valve. The movable cover 9 of the head 5 allows to operate a spindle valve indicated by 14. The shaft 15 of the said valve, is biased to closed position by a spring 16 in. When pressing the cover 9 in the direction of the arrow f, against the thrust of a spring means 17, the shaft 15 is pushed down allowing the flow of compressed air from the hose 7, through the valve 15, to a channel 18 in the head leading to the atomizing nozzle unit 10. As shown in FIG. 5, the removable atomizing nozzle unit 10 of the head 5 is formed of a first flow duct 19 connectable to the channel 18 for the compressed-air supply. In addition, the nozzle unit 10 is provided with a second inlet duct 20 leading to the lacquer in the bomb 1 and drawing lacquer therefor the Venturi principle. The end 19a of the nozzle for the compressed air duct 19 is closed to the orifice end 20a of the nozzle for the aspirated lacquer duct 20. The duct 20, 20a for drawing the lacquer ends in an upper cone 21, separated by a vertical notch 22 from the orifice 19a of the duct 19. The vertical notch 22 is most important for the safe operation of the nozzle unit 10, because it is this vertical notch 22 which allows the perfect and really surprising atomising effect. The cone 21 containing the orifice 20a of the duct 20 prevents the formation of droplets at the end of of the atomizing phase and therewith prevents the blocking of the ducts 19, 19a, 20, 20a.

1a

PRIORITY CLAIM [0001] The present application claims the benefit of copending U.S. Provisional Patent Application Ser. No. 61/263,776, filed Nov. 23, 2009, which application is incorporated herein by reference in its entirety. BACKGROUND [0002] A “biofilm” is a well known phenomenon and may be defined as a population of microbial cells growing on a surface and enclosed in a self-produced matrix of extracellular polymeric material, which mediates adhesion of the cells to each other and to surfaces. Biofilms are not simply passive assemblages of cells that are stuck to surfaces, but are structurally and dynamically complex biological systems. As compared with cells that are planktonic in nature, bacteria growing in biofilms exhibit a different phenotype with respect to growth rate and gene transcription. See http://en.wikipedia.org/wiki/Biofilm. [0003] Unwanted biofilms have been responsible, for example, for the fouling of cooling-water towers, water pipelines, membrane units and food-processing plants. Biofilms are notoriously difficult to eradicate. Microbes in industrial biofilms are protected from antimicrobial chemicals, environmental bacteriophages, and phagocytic amoebae. (Donlan R M, Costerton J W. Biofilms: survival mechanisms of clinically relevant microorganisms. Clin Microbiol Rev 2002;15167-293.) [0004] In addition to their importance in industry, biofilms may be involved in a significant percentage of human microbial infections (Potera C. Forging a link between biofilms and disease. Science 1999;283:1837-8). Parsek and Singh proposed four criteria for defining a biofilm etiology of an infection: the pathogenic bacteria are surface associated or adherent to a substratum; direct examination reveals bacteria in clusters, encased in a matrix of bacterial or host constituents; the infection is localized; and the infection is resistant to antibiotic therapy despite the antibiotic sensitivity of the constituent planktonic organisms (Parsek M R, Singh P K. Bacterial biofilms: an emerging link to disease pathogenesis. Annu Rev Microbiol 2003;57:677-701.) [0005] Biofilm infections can be involved in the etiology of dental caries, periodontal disease, cystic fibrosis (CF) airway infections, native valve endocarditis, chronic prostatitis, otitis media, and vaginal infections. Biofilm microorganisms are also involved in implant-related infections, in which adherent microbial populations form on the surfaces of catheters, prosthetic heart valves, joint replacements, and other devices (Donlan R M. Biofilms and device-associated infections. Emerg Infect Dis 2001;7:277-81.) [0006] The intestinal tract provides a reservoir for many antibiotic-resistant biofilm bacteria, including Enterobacteriaceae species, Pseudomonas aeruginosa, and Acinetobacter species (Donskey C J. The role of the intestinal tract as a reservoir and source for transmission of nosocomial pathogens. Clin Infect Dis 2004;39:219-26.) The human opportunistic pathogen, Pseudomonas aeruginosa, is a major cause of infection-related mortality among the critically ill patients, and carries one of the highest case fatality rates of all gram-negative infections. Although the lungs have been traditionally considered to be a major site of P. aeruginosa infection among critically ill patients, a significant number of these infections arise as a result of direct contamination of the airways by the gastrointestinal flora or by hematogenous dissemination from the intestines to the lung parenchyma. Effective methods for the inhibition, reduction and/or treatment of P. aeruginosa would have a significant impact for this condition. [0007] With respect to biofilms in the gut, it is now known that bacteria can exist for example as biofilms on the intestinal epithelium, within the mucus layer covering it, and on food particles in the lumen. (MacFarlane S, MacFarlane G T. Composition and metabolic activities of bacterial biofilms colonizing food residues in the gastrointestinal tract. Appl Environ Microbiol 2006;72:6204-11; Probert H M, Gibson G R. Bacterial biofilms in the human gastrointestinal tract . Curr Issues Intest Microbiol 2002;3:23-7.) Gastrointestinal biofilm-associated bacteria include Bacteroides ssp., Clostridium ssp., Fusobacterium ssp., Klebsiella ssp., Spirochaetes ssp., Pseudomonas aeriginosa, Escherichia coli, Helicobacter pylori, Bifidobacterium ssp., and gram-positive cocci. [0008] Thus, there has gone unmet a need for improved methods, compositions, etc., related to reduction of biofilms within the ear, vagina, joints, bones, gut, surgical sites and other locations in mammals. The present methods, etc., provide one or more of these and/or other advantages. SUMMARY [0009] The present compositions, medicaments, therapeutics, systems, methods, etc., are directed to the reduction or inhibition of harmful biofilm(s) in animals, for example biofilms occurring in conjunction with certain diseases or conditions including bacterial vaginosis, bacterial vaginitis or fungal vaginitis (i.e., inflammations of the vagina due to bacteria or fungi); osteomyelitis; otitis media; chronic sinusitis; chronic prostatitis, native valve endocarditis; biofilm on a mucosal surface; and, biofilm infections of medical implants and medical devices. The compositions include physiologically acceptable anti-biofilm compositions comprising at least Serratia peptidase in a therapeutic amount. In some embodiments, the compositions further comprise therapeutic amounts of one or more of bromelain, papain, and a fibrinolytic enzyme. The fibrinolytic enzyme can be, for example, nattokinase, lumbrokinase or Fusarium protease. Fusarium protease is a fibrinolytic enzyme that has been reported to be more potent than nattokinase in its fibrinolytic activity. [0010] The compositions are administered to the patient for a time sufficient to cause significant biofilm reduction on the target site, such as a mucosal surface, in the mammal. The compositions are administered, for example, as nutraceutical, therapeutic, or pharmaceutical compositions, and are typically suitable for oral ingestion by or topical application to mammals such as humans. The current discussion also includes methods of making and using or administering such compositions. [0011] In another aspect, the present physiologically acceptable anti-biofilm compositions, methods, etc., are also directed to the use of digestive enzymes for the inhibition and reduction of pathogenic biofilm in the gastrointestinal tract of humans. [0012] For example, the physiologically acceptable anti-biofilm compositions, methods, etc., can be directed to the use of cellulases, hemicellulases, lysozyme, pectinases, amylases, DNase I, β-1,6-N-acetylglucosaminidase, and other hydrolases that are capable of digesting the exopolysaccharide, exoprotein, and nucleotide matrix of biofilms. [0013] The present physiologically acceptable anti-biofilm compositions, methods, etc., are also directed to oral physiologically acceptable anti-biofilm compositions for the inhibition and treatment of pathogenic gastrointestinal biofilms in humans. [0014] In certain embodiments, the present physiologically acceptable anti-biofilm compositions, methods, etc., are directed to agents that are foodborne, waterborne or are nosocomial. Some embodiments are further directed to biofilm infections that are antibiotic-resistant and/or recurrent. The physiologically acceptable anti-biofilm compositions, etc., may be used in conjunction with antibiotics or antimicrobials. In addition these physiologically acceptable anti-biofilm compositions may be used in patients whose biofilm infections have failed to respond to antibiotics or antimicrobials. [0015] The present physiologically acceptable anti-biofilm compositions, methods, etc., are also directed to the inhibition and treatment of biofilm infections caused by bioterrorist agents. [0016] Thus, in one aspect, the present compositions, methods, etc., are directed to a physiologically acceptable anti-biofilm composition suitable for administration to a mammal, the composition comprising at least one pharmaceutically acceptable carrier and Serratia peptidase in amounts capable of significant biofilm degradation in the mammal upon administration to the mammal. [0017] In some embodiments, the present compositions, methods, etc., further comprise one or more of bromelain, papain and a fibrinolytic enzyme. The fibrinolytic enzyme can comprise at least one of nattokinase or lumbrokinase, and the composition can be configured for oral administration such that the composition can capable of gastrointestinal absorption while retaining the anti-biofilm activity after passing through the stomach. The composition can also be administered via any other suitable route, such as topically, and other indirect or direct routes, such as buccal/sublingual, rectal, oral, nasal, vaginal, pulmonary, intraperitoneal, subcutaneous, intranasal, or intravenous. [0018] The compositions, methods, etc., further can comprise at least one chelating agent capable of chelating at least one of calcium or iron configured for administration in an amount capable of significant biofilm degradation in the mammal. The chelating agent can be at least one of lactoferrin or a lactoferrin peptide capable of chelation. [0019] The compositions, methods, etc., further can comprise at least one of an anti-biofilm acid-stable cellulase or an anti-biofilm anti-polymeric β-,6-N-acetyl-D-glucosamine (poly-β-,6-GlcNAc) agent, or at least one of an acid-stable hemicellulase/pectinase complex, B-gluconase, acid protease, or alkaline protease. The composition further can comprise at least one acid-stable agent selected from the following: a disaccharidase; amylase; α-amylase; β-amylase; glucoamylase; endoglucanase; xylanase; lipase; lysozyme; an enzyme with dipeptidyl peptidase IV (DPP-IV) activity; chitosanase; ficin; kiwi protease; any plant-derived protease or proteinase, or phytase. The composition further can comprise at least one acid-stable enzyme configured for administration in an amount capable of significant biofilm degradation in the mammal, the at least one enzyme selected from the following: 1,2-1,3-α-D-mannan mannohydrolase, 1,3-β-D-xylanxylanohydrolase, 1,3-β-D-glucan glucanohydrolase, 1,3(1,3;1,4)-α-D-glucan 3-glucanohydrolase, 1,3(1,3;1,4)-β-D-glucan 3(4)-glucanohydrolase, 1,3-1,4-α-D-glucan 4-glucanohydrolase, 1,4-α-D-glucan glucanehydrolase, 1,4-α-D-glucan glucohydrolase, 1,4-(1,3:1,4)-β-D-glucan 4-glucanohydrolase, 1,4-β-D-glucan glucohydrolase, 1,4-β-D-xylan xylanohydrolase, 1,4-β-D-mannan mannanohydrolase, 1,5-α-L-arabinanohydrolase, 1,4-α-D-glucan maltohydrolase, 1,6-α-D-glucan 6-glucanohydrolase, 2,6-β-fructan fructanohydrolase, α-dextrin 6-glucanohydrolase, α-D-galactoside galactohydrolase, α-D-glucoside glucohydrolase, α-D-mannoside mannohydrolase, acylneuraminyl hydrolase, Aerobacter-capsular-polysaccharide galactohydrolase, α-D-fructofuranoside fructohydrolase, β-D-fucoside fucohydrolase, α-D-fructan fructohydrolase, β-D-galactoside galactohydrolase, β-D-glucoside glucohydrolase, β-D-glucuronoside, glucuronosohydrolase, β-D-mannoside mannohydrolase, β-N-acetyl-D-hexosaminide N-acetylhexosamino hydrolase, cellulose-sulfate sulfohydrolase, collagenase, dextrin 6-α-D-glucanohydrolase, glycoprotein-phosphatidylinositol phosphatidohydrolase, hyaluronate 4-glycanohydrolase, hyaluronoglucuronidase, pectin pectylhydrolase, peptidoglycan N-acetylmuramoylhydrolase, phosphatidylcholine 2-acylhydrolase, phosphatidylcholine 1-acylhydrolase, poly(1,4-α-D-galacturonide), poly(1,4-(N-acetyl-β-D-glucosaminide))-glycanohydrolase, proteases, sucrose α-glucosidase, triacylglycerol acylhydrolase, triacylglycerol protein-acylhydrolase. [0020] The compositions, methods, etc., also can comprise a green tea extract, an acid-stable subtilisin or an acid-stable DNAse I, a chelating agent selected from the group comprising ethylenediamine-N,N,N′,N′-tetraacetic acid (EDTA); the disodium, trisodium, tetrasodium, dipotassium, tripotassium, dilithium and diammonium salts of EDTA; the barium, calcium, cobalt, copper, dysprosium, europium, iron, indium, lanthanum, magnesium, manganese, nickel, samarium, strontium, and zinc chelates of EDTA; trans-1,2-diaminocyclohexane-N,N,N′,N′-tetraaceticacid monohydrate; N,N-bis(2-hydroxyethyl)glycine; 1,3-diamino-2-hydroxypropane-N,N,N′,N′-tetraacetic acid; 1,3-diaminopropane-N,N,N′,N′-tetraacetic acid; ethylenediamine-N,N′-diacetic acid; ethylenediamine-N,N′-dipropionic acid dihydrochloride; ethylenediamine-N,N′-bis(methylenephosphonic acid)hemihydrate; N-(2-hydroxyethyl)ethylenediamine-N,N′,N′-triacetic acid; ethylenediamine-N,N,N′,N′-tetrakis(methylenephosponic acid); O,O′-bis(2-aminoethyl)ethyleneglycol-N,N,N′,N′-tetraacetic acid; N,N-bis(2-hydroxybenzyl)ethylene diamine-N,N-diacetic acid; 1,6-hexamethylenediamine-N,N,N′,N′-tetraacetic acid; N-(2-hydroxyethyl)iminodiacetic acid; iminodiacetic acid; 1,2-diaminopropane-N,N,N′,N′-tetraacetic acid; nitrilotriacetic acid; nitrilotripropionic acid; the trisodium salt of nitrilotris(methylenephosphoric acid); 7,19,30-trioxa-1,4,10,13,16,22,27,33-octaazabicyclo[11,11,11]pentatriacontane hexahydrobromide; triethylenetetraminie-N,N,N′,N″,N′″,N′″-hexaacetic acid; deferoxamine; deferiprone; and deferasirox. [0021] The compositions, methods, etc., further can comprise, or exclude, an antibiotic, and can comprise quercetin, seaprose or Fusarium protease. [0022] Another aspect herein is directed to methods of inhibiting a biofilm infection in a mammal comprising: identifying the presence of the biofilm infection, administering to the mammal a therapeutically effective amount of a composition comprising at least one pharmaceutically acceptable carrier and Serratia peptidase, bromelain, papain and a fibrinolytic enzyme in amounts capable of significant biofilm degradation in the mammal, in an amount and for a time sufficient to cause significant biofilm degradation within the mammal. [0023] The methods further can comprise identifying the presence of the biofilm infection in the gastrointestinal system of the mammal, and orally administering to the mammal the therapeutically effective amount of the composition in an amount and for a time sufficient to cause significant biofilm degradation within the gut of the mammal. [0024] The methods further can comprise identifying the presence of the biofilm infection at a surface of a body part of the mammal other than the gastrointestinal system, and topically administering to the surface of the body part the therapeutically effective amount of the composition in an amount and for a time sufficient to cause significant biofilm degradation at the surface of the body part. The surface can be for example exposed skin or an internal surface of the mammal. As with certain other methods and compositions herein, the methods can also comprise other routes and/or targets of administration. [0025] The methods further can comprise administering at least one of lactoferrin and a chelating agent; at least one of an anti-biofilm acid-stable cellulase or an anti-biofilm anti-polymeric β-1,6-N-acetyl-D-glucosamine (poly-β-1,6-GlcNAc) agent; or, at least one of an acid-stable hemicellulase/pectinase complex, β-gluconase, acid protease, or alkaline protease in an amount and for a time sufficient to cause significant biofilm degradation within of the mammal. [0026] The methods further can comprise administering at least one an acid-stable agent, for example selected from the following: a disaccharidase; amylase; α-amylase; β-amylase; glucoamylase; endoglucanase; xylanase; lipase; lysozyme; an enzyme with dipeptidyl peptidase IV (DPP-IV) activity; chitosanase; ficin; kiwi protease; any plant-derived protease or proteinase, or phytase. The methods also can comprise administering at least one an acid-stable selected from the following: 1,2-1,3-α-D-mannan mannohydrolase, 1,3-β-D-xylanxylanohydrolase, 1,3-β-D-glucan glucanohydrolase, 1,3(1,3;1,4)-α-D-glucan 3-glucanohydrolase, 1,3(1,3;1,4)-β-D-glucan 3(4)-glucanohydrolase, 1,3-1,4-α-D-glucan 4-glucanohydrolase, 1,4-α-D-glucan glucanehydrolase, 1,4-α-D-glucan glucohydrolase, 1,4-(1,3:1,4)-β-D-glucan 4-glucanohydrolase, 1,4-β-D-glucan glucohydrolase, 1,4-β-D-xylan xylanohydrolase, 1,4-β-D-mannan mannanohydrolase, 1,5-α-L-arabinanohydrolase, 1,4-α-D-glucan maltohydrolase, 1,6-α-D-glucan 6-glucanohydrolase, 2,6-β-fructan fructanohydrolase, α-dextrin 6-glucanohydrolase, α-D-galactoside galactohydrolase, α-D-glucoside glucohydrolase, α-D-mannoside mannohydrolase, acylneuraminyl hydrolase, Aerobacter-capsular-polysaccharide galactohydrolase, β-D-fructofuranoside fructohydrolase, β-D-fucoside fucohydrolase, α-D-fructan fructohydrolase, β-D-galactoside galactohydrolase, β-D-glucoside glucohydrolase, β-D-glucuronoside, glucuronosohydrolase, β-D-mannoside mannohydrolase, β-N-acetyl-D-hexosaminide N-acetylhexosamino hydrolase, cellulose-sulfate sulfohydrolase, collagenase, dextrin 6-α-D-glucanohydrolase, glycoprotein-phosphatidylinositol phosphatidohydrolase, hyaluronate 4-glycanohydrolase, hyaluronoglucuronidase, pectin pectylhydrolase, peptidoglycan N-acetylmuramoylhydrolase, phosphatidylcholine 2-acylhydrolase, phosphatidylcholine 1-acylhydrolase, poly(1,4-α-D-galacturonide), poly(1,4-(N-acetyl-β-D-glucosaminide))-glycanohydrolase, proteases, sucrose α-glucosidase, triacylglycerol acylhydrolase, triacylglycerol protein-acylhydrolase. [0027] The methods further can comprise administering at least one of an acid-stable subtilisin and an acid-stable DNAse I in an amount and for a time sufficient to cause significant biofilm degradation within of the mammal. The methods can also comprise: identifying the presence of at least one of Clostridium ssp, Klebsiella ssp, Pseudomonas ssp, Bacteroides ssp, Enterococcus ssp, Campylobacter ssp, Bacillus ssp, Yersinia ssp, Brucella ssp, Salmonella ssp, Shigella ssp, Fusobacterium ssp, Spirochaetes ssp, Entamoeba ssp, Candida ssp, Escherichia coli, Vibrio cholerae, Staphylococcus ssp, Streptococcus ssp, Hemophilus ssp, Aspergillus ssp and Gardnerella ssp in the mammal, and, administering to the mammal a therapeutically effective amount of the anti-biofilm Serratia peptidase agent for a time sufficient to treat the identified microorganism. [0028] The methods can comprise administering, or not administering, an antibiotic in conjunction with the Serratia peptidase, and other possible elements of the composition as discussed herein. The methods further can also comprise administering one or more of an quercetin, seaprose or Fusarium protease in an amount and for a time sufficient to cause significant biofilm degradation within of the mammal. [0029] In a further aspect, the methods comprise inhibiting at least one of bacterial vaginosis, bacterial vaginitis or fungal vaginitis in a mammal, the methods comprising: identifying the presence of the at least one of bacterial vaginosis, bacterial vaginitis or fungal vaginitis, administering to the mammal a therapeutically effective amount of a composition comprising at least one pharmaceutically acceptable carrier and Serratia peptidase, in an amount capable of significant reduction of the bacterial vaginosis, bacterial vaginitis or fungal vaginitis in the mammal, in an amount and for a time sufficient to cause significant bacterial vaginosis, bacterial vaginitis or fungal vaginitis reduction within the mammal. In another aspect, the methods comprise inhibiting otitis media in a mammal, the methods comprising: identifying the presence of the otitis media, administering to the mammal a therapeutically effective amount of a composition comprising at least one pharmaceutically acceptable carrier and Serratia peptidase, in an amount capable of significant reduction of the otitis media in the mammal, in an amount and for a time sufficient to cause significant otitis media reduction within the mammal. In yet another aspect, the methods comprise inhibiting osteomyelitis in a mammal, the methods comprising: identifying the presence of the osteomyelitis, administering to the mammal a therapeutically effective amount of a composition comprising at least one pharmaceutically acceptable carrier and Serratia peptidase, in an amount capable of significant osteomyelitis reduction in the mammal, in an amount and for a time sufficient to cause significant osteomyelitis reduction within the mammal. And, in a further aspect, the methods comprise inhibiting a biofilm on a mucosal surface in a mammal, the method comprising: identifying the presence of the biofilm on a mucosal surface, administering to the mammal a therapeutically effective amount of a composition comprising at least one pharmaceutically acceptable carrier and Serratia peptidase, in an amount capable of significant biofilm reduction on the mucosal surface in the mammal, in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal. Such methods can further comprise one or more of the other features discussed herein. [0030] These and other aspects, features, and embodiments are set forth within this application, including the following Detailed Description. Unless expressly stated otherwise, all embodiments, aspects, features, etc., can be mixed and matched, combined, and permuted in any desired manner. DETAILED DESCRIPTION [0031] Biofilms in mammals have been implicated in a variety of possible diseases, either as causing such diseases or making them worse. The present compositions, systems, methods, etc., are directed to the reduction of biofilm(s) in certain sites and/or associated with certain diseases or disorders in animals, including bacterial vaginosis, bacterial vaginitis or fungal vaginitis; osteomyelitis; otitis media; chronic sinusitis; biofilm on a mucosal surface; and, biofilm infections of medical implants and medical devices. The methods include inhibiting, treating, or reducing biofilms in such locations. Exemplary Enzymes That Treat, Inhibit, Etc., Biofilms [0032] Enzymes that disrupt the biofilm matrices of these organisms within the gastrointestinal tract or other target area are the subject of the methods, etc., herein. Serratia Peptidase [0033] Serratia peptidase, also known as serrapeptase, is a known enzyme that is an extracellular metalloprotease produced by Serratia sp. E15. Serratia peptidase is known to be absorbed in the GI tract. Serratia peptidase can be enterically coated for example as tablets, and formulations including monovalent alginate. Tablets of Serratia peptidase (5 mg/tablet) are marketed as Danzen or Dasen™ (Takeda Chemical Industries, Ltd.), Aniflazym® (Takeda Pharma GmbH) and Serodase (Hayat Pharmaceutical Industries, Ltd.) Serratia peptidase may have been sold for use as an anti-inflammatory, analgesic and mucolytic. Bromelain & Papain [0034] Bromelain and papain are known enzymes and are known to be active within the gastrointestinal tract. Oral bromelain may have been reported to inhibit enterotoxigenic E. Coli attachment to the small intestine in piglets, possibly by modifying receptor attachment sites. Bromelain is absorbed through the intestine and it has anti-edema, anti-inflammatory and anti-coagulation effects. Oral bromelain has been reported to attenuate inflammation in a murine model of asthma and to inhibit lung metastases. [0035] Phlogenzym® (Mucos Pharma GmbH & Co.) includes bromelain (90 mg), trypsin (48 mg) and the antioxidant flavonoid, rutin (100 mg) and has been reported to reduce inflammation and experimental allergic encephalomyelitis. Wobenzym® N is reportedly a combination of bromelain, papain, trypsin, chymotrypsin, and rutin. Wobe-Mugos®, reportedly contains trypsin, chymotrypsin and papain, has been reported to be as effective as acyclovir in the treatment of herpes zoster. Lactoferrin [0036] Lactoferrin is also known as lactotransferrin. It is a naturally-occurring molecule, and is an extracellular iron-binding glycoprotein which can be found in mucosal secretions, including those found in the respiratory tract, gastrointestinal tract, and urogenital tract. It is also released by neutrophils at sites of infection. During infection, the binding of iron by lactoferrin is proposed to reduce the amount of free extracellular iron. This process, known as the hypoferremia of infection, is thought to further limit the free iron available to invading microorganisms. Lactoferrin can be absorbed through the intestines. Enteric-formulated lactoferrin is more efficiently absorbed from the intestine than is non-enteric-formulated lactoferrin. [0037] To applicant's knowledge, lactoferrin has not been combined with Serratia peptidase, bromelain or papain. Otitis Media [0038] Otitis media has been described as an inflammation of the middle ear that is common in children. Vaginosis [0039] Bacterial vaginosis (BV) is a common lower genital tract syndrome affecting women of reproductive age. BV is associated with adverse outcomes among nonpregnant and pregnant women. BV has been found to be associated with preterm labor, preterm delivery, low birth weight, postcesarean endometritis, and postabortion pelvic inflammatory disease. BV occurs when there are changes of the normal flora of the vagina, causing an increased prevalence of Gardnerella vaginalis, Mycoplasma hominis, and anaerobic organisms and a decreased prevalence of the normally predominant Lactobacillus species. Previous studies have shown that the alteration of the normal flora may increase the risk of acquiring BV, HIV type 1, or other sexually transmitted diseases. [0040] To applicant's knowledge, treatments recommended by the Centers for Disease Control (CDC) for BV include metronidazole or clindamycin administered orally or intravaginally. Metronidazole is a nitroimidazole with activity against anaerobic organisms, while clindamycin, a macrolide, has a broad spectrum of activity against a variety of microbes including aerobic and anaerobic organisms. The CDC recommends oral metronidazole for 7 days or vaginal metronidazole gel for 5 days, as they are equally effective. Metronidazole offers average cure rates of 80% to 90%. Also, metronidazole is thought to be most effective for treating infection that has spread into the upper reproductive tract. The CDC also recommends clindamycin cream 2% for 7 days, while noting that it might not be as effective as metronidazole. [0041] Despite treatment with either metronidazole or clindamycin, similar percentages of women (approximately 10 to 15%) fail therapy after 1 month. The proportion of women who relapse also increases over time. The recurrence rate of BV is approximately 30% at 3 months and approximately 50 to 80% at 1 year following therapy with either drug. Clindamycin's relapse rate is higher: 4 weeks after clindamycin treatment, 56% of women have recurring bacterial vaginosis. Current therapy for managing recurrent BV is repeated treatment with antibiotics. An obvious problem and important health issue associated with repeated exposure to the same antibiotic is resistance of those microbes targeted by the drug, which can result in an alteration of flora and possible persistence of BV-associated pathogens. [0042] Recent studies have shown an emergence of clindamycin-resistant genital organisms among clinically relevant bacteria, including group B streptococci. Resistance of BV to oral metronidazole has been postulated to result from the adherent G. vaginalis biofilm that persists after standard therapy. In vitro models for G. vaginalis biofilm have been developed. Orthopedic Implants and Medical Devices [0043] Implant-related infections are difficult to treat with antimicrobial agents alone. Several groups have reported on the properties of implant-associated biofilms and on the need for ancillary or adjunct therapies. [0044] The compositions and methods herein may not only treat but may inhibit or prevent implant-related infections via chronic administration of safe and effective oral compositions without antibiotics. Other Enzymes and Molecules [0045] In one aspect the suitable, physiologically acceptable anti-biofilm compositions, etc., herein further comprise an amount of quercetin, seaprose (also known as seaprose-S) and/or Fusarium protease in conjunction with the Serratia peptidase, bromelain, papain and a fibrinolytic enzyme, in an amount and for a time sufficient to cause significant biofilm degradation within of the mammal. [0046] Quercetin is an anti-inflammatory bioflavonoid. The composition is claimed for the treatment of non-bacterial cystitis. It has been reported that quercetin alone does not have a high bioavailability due to the fact that transmural intestinal absorption is relatively low. [0047] Seaprose, also known as Protease S or Seaprose S, is a semi-alkaline serine-proteinase produced by the fungus Aspergillus melleus. Seaprose-S reportedly demonstrates an ability to reduce painful inflammation and break up mucus. [0048] In one aspect the suitable, physiologically acceptable anti-biofilm compositions, etc., herein further comprise an amount of anti-polymeric β-1,6-N-acetyl-D-glucosamine (poly-β-1,6-GlcNAc) agents to substantially disperse poly-β-1,6-GlcNAc and thus capable of significant biofilm degradation. E.g., see Itoh Y, Wang X, Hinnebusch B J, Preston J F, Romeo T. Depolymerization of β-1,6-N-acetyl-D-glucosamine disrupts the integrity of diverse bacterial biofilms. J Bacteriol 2005;187;382-7) In some embodiments, for this and other agents, either alone or in combination, such significant reduction means, if measured in vitro, a log reduction of 1, typically 1.5, or 3.0-3.8 or better. In vivo, such significant reduction can be substantial reduction of one or more symptoms associated with a biofilm infection, or even substantial elimination of one or more symptoms associated with a biofilm infection. Exemplary anti-GlcNAc-agents include a previously identified β-hexosaminidase and biofilm-dispersing enzyme of A. actinomycetemcomitans, DspB or dispersin B, which specifically hydrolyzes the glycosidic linkages of poly-β-1,6-GlcNAc and disrupts bacterial biofilm (Kaplan J B, Ragunath C, Ramasubbu N, Fine D H. 2003. Detachment of Actinobacillus actinomycetemcomitans biofilm cells by an endogenous β-hexosaminidase activity. J Bacteriol 2003;185:4693-8). Dispersin B cleaves β(1,6)-linked N-acetylglucosamine polymer using a catalytic machinery similar to other family 20 hexosaminidases which cleave β(1,4)-linked N-acetylglucosamine residues. Dispersin B and similar hexosaminidases with activity in biofilms are suitable for use in the methods, physiologically acceptable anti-biofilm compositions, etc., discussed herein. The anti-poly-β-1,6-GlcNAc agents can be used with, or instead of, cellulase, discussed further below, although typically they are used together. [0049] In one aspect the suitable, physiologically acceptable anti-biofilm compositions comprise a cellulase in an amount capable of significant biofilm degradation. Such cellulases can have activity; against, for example, cellulose in a Salmonella biofilm or others. Cellulase refers to a class of enzymes produced chiefly by fungi, bacteria, and protozoans that catalyze the hydrolysis of cellulose. However, there are also cellulases produced by other types of organisms such as plants and animals. Cellulases that have been used as digestive enzymes are known to be acid-stable. These include but are not limited to cellulases from Aspergillus species. Several different kinds of cellulases are known, which differ structurally and mechanistically. The EC number for this group of enzymes is EC 3.2.1.4. The reaction catalyzed is the endohydrolysis of 1,4-β-D-glycosidic linkages in cellulose. Other names for cellulase are: Endoglucanase, endo-1,4-β-glucanase, carboxymethyl cellulose, endo-1,4-β-D-glucanase, β-1,4-glucanase, β-1,4-endoglucan hydrolase, celludextrinase, avicelase. Cellulases have been used in vitro in the disruption of biofilms on medical implants under acidic pH conditions (Loiselle M, Anderson K W, The use of cellulase in inhibiting biofilm formation from organisms commonly found on medical implants. Biofouling 2003;19:77-85.) In typical embodiments, the cellulase(s) herein are resistant to denaturation/inactivation at a pH range of 1.0 to 5.0 and 10 to 14, possesses hydrolytic activity across a pH span of 1 to 14, has effective hydrolytic activity within the gastric environment at a fasting pH of 1.0 to 3.0 and in the presence of food and other ingested material, and/or possesses effective hydrolytic activity at a pH of 4.5 to 7.5 encompassing physiologic pH in the small intestines and colon. [0050] Commercial sources of cellulases, hemicellulases and other enzymes that may be used include the following: Deerland Enzymes, Kennesaw, G A (www.deerland-enzymes.com); National Enzyme Company (www.nationalenzyme.com), Specialty Enzymes (www.specialtyenzymes.com); and others. The enzymes may be derived from any suitable source such as plant, bacterial, fungal or animal sources. [0051] In one embodiment, the anti-biofilm compositions herein further comprise physiologically acceptable cellulase, hemicellulase/pectinase complex, β-gluconase, acid protease, and alkaline protease, with at least one pharmaceutically acceptable carrier, diluents, excipients, buffers, or adjuvants. Pharmaceutically acceptable carriers or diluents, excipients, buffers, adjuvants, and the like are nontoxic to recipients at the dosages and concentrations employed. [0052] In one embodiment, the amount of cellulase per oral dose is about 100-300 CU, and typically about 200 CU; the amount of hemicellulase/pectinase complex is about 60-100 HSU, and typically about 80 HSU; the amount of β-gluconase is about 6-10 BGU, and typically about 8 BGU; the amount of acid protease is about 15-25 SAP, and typically about 20 SAP; and, the amount of alkaline protease is about 15-25 HUT, and typically about 20 HUT. [0053] In still further embodiments, the amount of cellulase per oral dose ranges from 1 to 10,000 CU, the amount of hemicellulase/pectinase complex ranges from 1 to 8,000 HSU, the amount of B-gluconase ranges from 1 to 1000 BGU, the amount of acid protease ranges from 1 to 10,000 SAP, and the amount of alkaline protease ranges from 1 to 40,000 HUT. [0054] In a further embodiment, the physiologically acceptable anti-biofilm composition comprises cellulase, hemicellulase/pectinase complex, β-gluconase, acid protease, alkaline protease, and any one or more of the following in an amount capable an amount capable of significant biofilm degradation: disaccharides, amylase, -amylase, β-amylase, glucoamylase, endoglucanase, xylanase, lipase, lysozyme, any enzyme such as a protease, peptidase or protease/peptidase complex with dipeptidyl peptidase IV (DPP-IV) activity, chitosanase, bromelain, papain, ficin, kiwi protease, any plant-derived protease or proteinase, or phytase. [0055] In a further embodiment, the physiologically acceptable anti-biofilm composition is composed of cellulase, hemicellulase/pectinase complex, β-gluconase, acid protease, alkaline protease, and any one or more of the following specific enzymes in an amount capable of biofilm degradation: 1,2-1,3- -D-mannan mannohydrolase, 1,3-β-D-xylanxylanohydrolase, 1,3-β-D-glucan glucanohydrolase, 1,3(1,3;1,4)- -D-glucan 3-glucanohydrolase, 1,3(1,3;1,4)-β-D-glucan 3(4)-glucanohydrolase, 1,3-1,4- -D-glucan 4-glucanohydrolase, 1,4- -D-glucan glucanehydrolase, 1,4- -D-glucan glucohydrolase, 1,4-(1,3:1,4)-β-D-glucan 4-glucanohydrolase, 1,4-β-D-glucan glucohydrolase, 1,4-β-D-xylan xylanohydrolase, 1,4-β-D-mannan mannanohydrolase, 1,5- -L-arabinanohydrolase, 1,4- -D-glucan maltohydrolase, 1,6- -D-glucan 6-glucanohydrolase, 2,6-β-fructan fructanohydrolase, -dextrin 6-glucanohydrolase, -D-galactoside galactohydrolase, -D-glucoside glucohydrolase, -D-mannoside mannohydrolase, acylneuraminyl hydrolase, Aerobacter-capsular-polysaccharide galactohydrolase, β-D-fructofuranoside fructohydrolase, β-D-fucoside fucohydrolase, -D-fructan fructohydrolase, β-D-galactoside galactohydrolase, β-D-glucoside glucohydrolase, β-D-glucuronoside, glucuronosohydrolase, β-D-mannoside mannohydrolase, β-N-acetyl-D-hexosaminide N-acetylhexosamino hydrolase, cellulose-sulfate sulfohydrolase, collagenase, dextrin 6- -D-glucanohydrolase, glycoprotein-phosphatidylinositol phosphatidohydrolase, hyaluronate 4-glycanohydrolase, hyaluronoglucuronidase, pectin pectylhydrolase, peptidoglycan N-acetylmuramoylhydrolase, phosphatidylcholine 2-acylhydrolase, phosphatidylcholine 1-acylhydrolase, poly(1,4- -D-galacturonide), poly(1,4-(N-acetyl-β-D-glucosaminide))-glycanohydrolase, proteases, sucrose -glucosidase, triacylglycerol acylhydrolase, triacylglycerol protein-acylhydrolase. [0056] Another group of enzymes that may be employed in the methods, etc. herein is a sub-group of serine proteases commonly designated as subtilisins. A subtilisin is a serine protease produced by Gram-positive bacteria or fungi. The amino acid sequences of a number of subtilisins have been determined, including at least six subtilisins from Bacillus strains, namely, subtilisin 168, subtilisin BPN, subtilisin Carlsberg, subtilisin DY, subtilisin amylosacchariticus, and mesentericopeptidase, one subtilisin from an actinomycetales, thermitase from Thermoactinomyces vulgaris, and one fungal subtilisin, proteinase K from Tritirachium album. [0057] An exemplary lipase as discussed above can be a microbial lipase. As such, the lipase may be selected from yeast lipases, e.g., Candida, and bacterial lipases, e.g., Pseudomonas or Bacillus, lipases; or fungal, e.g., Humicola or Rhizomucor. [0058] Examples of amylases useful in the methods, etc., herein include Bacillus amylases, e.g., Bacillus stearothermophilus amylase, Bacillus amyloliquefaciens amylase, Bacillus subtilis amylase or Bacillus licheniformis amylase or Aspergillus amylases, e.g., Aspergillus niger or Aspergillus oryzae amylase. [0059] Another group of enzymes useful in the methods, etc., herein include pectinases belonging to the enzyme classes polygalacturonases (EC3.2.1.15), pectinesterases (EC3.2.1.11), pectin lyases (EC4.2.2.10) and hemicellulases such as endo-1,3-β-xylosidase (EC 3.2.1.32), xylan 1,4-β-xylosidase (EC 3.2.1.37) and -L-arabinofuranosidase (EC 3.2.1.55). A suitable source organism for pectinases may be Aspergillus niger or Aspergillus aculeatus. [0060] Lysozyme, also known as muramidase or N-acetylmuramide glycanhydrolase, is a 14.4 kilodalton enzyme (EC 3.2.1.17) that damages bacterial cell walls by catalyzing hydrolysis of 1,4-β-linkages between N-acetylmuramic acid and N-acetyl-D-glucosamine residues in a peptidoglycan and between N-acetyl-D-glucosamine residues in chitodextrins. Lysozyme is found in saliva, tears, and polymorphonucleocytes and has known antibacterial activity. The enzyme functions by attacking peptidoglycans (found in the cells walls of bacteria, especially Gram-positive bacteria) and hydrolyzing the glycosidic bond that connects N-acetylmuramic acid with the fourth carbon atom of N-acetylglucosamine. Lysozyme has been used in the treatment of otitis media and sinusitis (U.S. Pat. No. 7,060,674). Oral lysozyme compositions have been used in the treatment of various conditions in humans, including arthritis (U.S. Pat. No. 7,229,809). [0061] Another enzyme that may be employed in the methods, etc. herein is deoxyribonuclease I (DNase I), a phosphodiesterase capable of hydrolyzing polydeoxyribonucleic acid. DNase I has been purified from various species to various degrees. DNase I, when inhaled, affects the capability of P. aeruginosa to form biofilms in the lungs in the initial development stages. DNase I hydrolyzes the DNA present in sputum/mucus of cystic fibrosis patients and reduces viscosity in the lungs, promoting improved clearance of secretions. Enzymes that are acid-stable are candidates for use in conjunction with the methods, physiologically acceptable anti-biofilm compositions, etc., discussed herein. DNase I activities are classifiable into three groups on the basis of their different tissue distributions of DNase I. DNase I of parotid type is secreted from the parotid gland and must pass through the very acidic conditions in the stomach. [0062] The physiologically acceptable anti-biofilm compositions, methods, etc., herein are to be taken by mouth, typically at least 1 hour before or 2 hours after a meal or consumption of food. The physiologically acceptable anti-biofilm compositions, methods, etc., herein are typically to be taken 2 to 4 times per day (other intervals may be appropriate in certain circumstances) and the regimen is typically to be followed for an extended period, for example at least about 1 or 2 months. [0063] The enzyme preparations may be combined with a natural antimicrobial such as oil of oregano, berberine, or undecylenic acid or with a prescription antibiotic or antimicrobial. [0064] The enzyme preparations may be combined with the oral intake of one or more probiotic microorganisms or prebiotic compositions. For example, such preparations can be consumed in the same composition as a probiotic microorganisms or prebiotic composition, simultaneously with such probiotic microorganisms or prebiotic compositions, or separately but in conjunction with such probiotic microorganisms or prebiotic compositions. The World Health Organization defines probiotic organisms as live microorganisms that when administered in adequate amounts confer a health benefit on the host. The enzyme preparation may be combined with one or more prebiotics. A prebiotic is defined as “selectively fermented ingredients that allow specific changes, both in the composition and/or activity in the gastrointestinal microflora that confer benefits upon host well-being and health.” (Roberfroid M. Prebiotics: the concept revisited. J Nutr 2007;137(3 Suppl 2):830S-7S.) [0065] Methods related to the compositions, etc., herein include methods of screening, making and using, including for the manufacture of medicaments. [0066] In some aspects, the methods comprise inhibiting a biofilm infection in a mammal, for example gastrointestinal or at one of the other target sites discussed herein, the method comprising: identifying the presence of the biofilm infection, administering, orally or otherwise, to the mammal a therapeutically effective amount of at least one anti-biofilm agent comprising at least one pharmaceutically acceptable carrier and a therapeutic amount of Serratia peptidase, in amounts capable of significant biofilm degradation in the mammal upon administration to the mammal. In further embodiments the methods comprise administering one or more of bromelain, papain and a fibrinolytic enzyme with the Serratia peptidase, and one or more of the other aspects or elements of the compositions, etc., herein. [0067] The compositions herein can be for use as an active therapeutic substance, for use in the manufacture of a medicament for inhibiting or treating a gastrointestinal biofilm in a mammal, or for manufacturing a medicament able to reduce symptoms associated with a gastrointestinal biofilm in a human patient, for example comprising combining a pharmaceutically effective amount of and a therapeutic amount of Serratia peptidase in an amount capable of significant biofilm degradation with at least one of a pharmaceutically acceptable carrier, adjuvant, excipient, buffer and diluent. In further embodiments the methods further comprise administering one or more of bromelain, papain and a fibrinolytic enzyme with the Serratia peptidase, Exemplary Biofilm Targets [0068] Exemplary target biofilm organisms, including both indigenous and biofilm infectious organisms are discussed below. Enterococci [0069] Enterococci, although part of the normal flora of the human gastrointestinal tract, have been recognized as an important cause of nosocomial infection for over two decades and are commonly implicated in urinary tract infections, bacteremia, intra-abdominal and surgical wound infections, catheter-related infections, and endocarditis. Staphylococcus [0070] Pathogenic staphylococci can form biofilms in which they show a higher resistance to antibiotics and the immune defense system than their planktonic counterparts. Staphylococcus aureus is a common pathogen associated with nosocomial infections. It can persist in clinical settings and gain increased resistance to antimicrobial agents through biofilm formation. Staphylococcus aureus is among the leading pathogens causing bloodstream infections able to form biofilms on host tissue and indwelling medical devices and to persist and cause disease. Infections caused by S. aureus are becoming more difficult to treat because of increasing resistance to antibiotics (e.g., vancomycin or methicillin-resistant Staphylococcus aureus ). In a biofilm environment particularly, microbes exhibit enhanced resistance to antimicrobial agents. Pseudomonas [0071] The human opportunistic pathogen, Pseudomonas aeruginosa, is a major cause of infectious-related mortality among the critically ill patients, and carries one of the highest case fatality rates of all gram-negative infections. Although the lungs have been traditionally considered to be a major site of P. aeruginosa infection among critically ill patients, a significant number of these infections arise as a result of direct contamination of the airways by the gastrointestinal flora or by hematogenous dissemination from the intestine to the lung parenchyma. Pseudomonas aeruginosa causes severe infections in immunologically compromised patients and is a major pathogen in cystic fibrosis patients. An important virulence mechanism is the formation of a mucoid biofilm. Secreted alginate is a crucial constituent of the mucoid biofilm matrix. However, alginate-negative mutants of P. aeruginosa are also able to form nonmucoid biofilms, showing an architecture different from that of biofilms formed by alginate-overproducing mucoid P. aeruginosa (Nivens D E, Ohman D E, Williams J, Franklin M J. Role of alginate and its O acetylation in formation of Pseudomonas aeruginosa microcolonies and biofilms. J Bacteriol 2001;183:1047-57; Wozniak D J, Wyckoff T J, Starkey M, Keyser R, Azadi P, O'Toole G A, Parsek M R. Alginate is not a significant component of the extracellular polysaccharide matrix of PA14 and PAO1 Pseudomonas aeruginosa biofilms. Proc Natl Acad Sci USA 2003;100:7907-12.) [0000] Helicobacter pylori [0072] H. pylori is one of the more common human pathogens infecting 50% of the world's population. It is associated with duodenal ulcers, gastric ulcers, gastritis, and gastric carcinoma. Treatment of H. pylori is difficult involving multidrug regimens and lengthy treatment periods. There is a 10-20% relapse rate. Recent studies document the importance of biofilms in the pathogenesis of H. pylori disease. (Coticchia J M et al. Presence and density of Helicobacter pylori biofilms in human gastric mucosa in patients with peptic ulcer disease. J Gastrointest Surg. 2006;10:883-9) An oral multienzyme formulation holds great promise to facilitate the elimination of H. pylori biofilm and the eradication of H. pylori pathogens thereby reducing the risk of gastritis, peptic ulcer disease, and gastric cancer. Listeria [0073] The foodborne pathogen Listeria is the causative agent of listeriosis, a severe disease where the overt form has a severe mortality greater than 25%. Listeria monocytogenes can survive and grow over a wide range of environmental conditions such as refrigeration temperatures, low pH and high salt concentration. This allows the pathogen to overcome food preservation and safety barriers, and pose a potential risk to human health. Listeria monocytogenes may specifically be found in raw foods, such as unpasteurized fluid milk, raw vegetables, raw and cooked poultry. It has the ability to grow at low temperatures; thus, allowing it to grow in refrigerated foods. Listeria monocytogenes was thought to be exclusively associated as infections in animals, but recently, this pathogenic species has also been isolated, in its dormant form, in the intestinal tract of small percentage of the human population (Rouquette C, Berche P. The pathogenesis of infection by Listeria monocytogenes. Microbiologia 1996;12:245-58). Campylobacter [0074] Campylobacter jejuni is a species of curved, rod-shaped, Gram-negative microaerophilic, bacteria commonly found in animal feces. It is one of the most common causes of human gastroenteritis in the world. Food poisoning caused by Campylobacter species can be severely debilitating but is rarely life-threatening. It has been linked with subsequent development of Guillain-Barré syndrome (GBS), which usually develops two to three weeks after the initial illness. Contaminated food is a major source of isolated infections, with incorrectly prepared meat and poultry normally the source of the bacteria. Infection with C. jejuni usually results in enteritis, which is characterized by abdominal pain, diarrhea, fever, and malaise. The major gastrointestinal pathogen Campylobacter jejuni is shown to exist as three forms of monospecies biofilm in liquid culture. (Joshua G W, Guthrie-Irons C, Karlyshev A V, Wren B W. Biofilm formation in Campylobacter jejuni. Microbiology 2006; 152(Pt 2):387-96.) [0000] Bacillus anthracis [0075] Bacillus anthracis is a Gram-positive, endospore-forming bacterium and is the aetiological agent of pulmonary, gastrointestinal and cutaneous anthrax. In endemic areas in which humans and livestock interact, chronic cases of cutaneous anthrax are commonly reported. Currently, there are few data known to the inventor that account for the importance of the biofilm mode of life in B. anthracis, yet biofilms have been characterized in other pathogenic and non-pathogenic Bacillus species, including Bacillus cereus and Bacillus subtilis, respectively. B. anthracis readily forms biofilms which are inherently resistant to commonly prescribed antibiotics. (Lee K, Costerton J W, Ravel J, Auerbach R K, Wagner D M, Keim P, Leid J G. Phenotypic and functional characterization of Bacillus anthracis biofilms. Microbiology 2007;153(Pt 6):1693-701.) Yersinia [0076] Yersiniosis is an infectious disease caused by a bacterium of the genus Yersinia. In the United States, most human illness is caused by one species, Y. enterocolitica. Infection with Y. enterocolitica occurs most often in young children. Common symptoms in children are fever, abdominal pain, and diarrhea. Gastrointestinal symptoms are common in both the acute and chronic states of yersiniosis. Infection is most often acquired by eating contaminated food, especially raw or undercooked pork products. Drinking contaminated unpasteurized milk or untreated water can also transmit the infection. [0077] Yersinia pestis, the causative agent of bubonic plague, is transmitted to rodents and humans by the bites of fleas whose proventriculi are blocked by a dense mass of the biofilm bacteria. (Tan L, Darby C. A movable surface: formation of Yersinia sp. biofilms on motile Caenorhabditis elegans. J Bacteriol. 2004;186:5087-92.) The blockage starves the flea and stimulates it to bite repeatedly in search of blood meals, thus spreading the bacteria to new hosts. Biofilm models using Caenorhabditis elegans may be used to identify enzymes that kill Yersinia biofilms (Styer K L, Hopkins G W, Bartra S S, Plano G V, Frothingham R, Aballay A. Yersinia pestis kills Caenorhabditis elegans by a biofilm-independent process that involves novel virulence factors. EMBO reports 2005;10:992-7.) [0000] Brucella species [0078] Humans are generally infected in one of three ways: eating or drinking something that is contaminated with Brucella, breathing in the organism (inhalation), or having the bacteria enter the body through skin wounds. The most common way to be infected is by eating or drinking contaminated milk products. Salmonella [0079] Salmonella enterica, a foodborne pathogen that causes salmonellosis, is caused by the ingestion of bacteria that invade the intestinal epithelium and multiply there. Salmonella enterica is known to form biofilms, and its attachment to, and growth on, eukaryotic cells is facilitated by exopolysaccharides (Ledeboer & Jones, 2005). Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most persons recover without treatment. However, in some persons the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly. Shigella [0080] There are several different kinds of Shigella bacteria: Shigella sonnei, also known as “Group D” Shigella, accounts for over two-thirds of the shigellosis in the United States. Shigellosis is an infectious disease caused by a group of bacteria called Shigella. Most who are infected with Shigella develop diarrhea, fever, and stomach cramps starting a day or two after they are exposed to the bacterium. Some Shigella bacteria have become resistant to antibiotics. A second type, Shigella flexneri, or “group B” Shigella, accounts for almost all of the rest. Other types of Shigella continue to be important causes of disease in the developing world. One type found in the developing world, Shigella dysenteriae type 1, causes deadly epidemics there. [0000] Typhi (typhoid fever) [0081] Salmonella enterica serovar Typhi causes typhoid fever, an enteric fever that is potentially fatal. Asymptomatic carriers may carry bacteria in the gallbladder. Salmonella typhi lives only in humans. Persons with typhoid fever carry the bacteria in their bloodstream and intestinal tract. In addition, a small number of persons, called carriers, recover from typhoid fever but continue to carry the bacteria. Both ill persons and carriers shed S. typhi in their feces (stool). Salmonella typhi is transmitted in contaminated food, water and beverages. A system was recently developed to analyze salmonella biofilm formation on glass coverslips (Prouty A M, Schwesinger W H, Gunn J S. Biofilm formation and interaction with the surfaces of gallstones by Salmonella spp. Infect Immun 2002;70:2640-9.) [0000] Escherichia coli [0082] Enterotoxigenic Escherichia coli targets the small intestine where the barrier effect of the autochthonous microflora is low due to higher acidity and peristaltic movements in this region. This organism adheres to and colonizes the mucus in order to elicit a pathogenic effect (Knutton S, Lloyd D R, Candy D C, McNeish A S. In vitro adhesion of enterotoxigenic Escherichia coli to human intestinal epithelial cells from mucosal biopsies. Infect Immun 1984;44:514-8.) This means that the pathogen and/or its toxins can readily adhere to exposed eneterocytes and invade the host. [0000] Vibrio cholerae (cholera) [0083] Vibrio cholerae is a Gram-negative, facultative pathogen that is the causative agent of cholera, a devastating diarrheal disease that affects millions of people in the developing world each year; it survives in aqueous reservoirs, probably in the form of biofilms. [0000] Entamoeba histolytica [0084] Invasive intestinal amebiasis, caused by Entamoeba histolytica, is initiated with attachment of trophozoites to the colonic mucous layer, mucous disruption and/or depletion, and adherence to and cytolysis of host epithelial and inflammatory cells. A current working model of intestinal amebiasis suggests that the microenvironment of the host intestine, particularly intestinal mucins and the bacterial biofilm, may influence the behavior of pathogenic amebae. Enzymes that disrupt bacterial biofilm will be useful in the inhibition and treatment of amebiasis. [0085] All terms used herein, are used in accordance with their ordinary meanings unless the context or definition clearly indicates otherwise. Also unless expressly indicated otherwise, the use of “or” includes “and” and vice-versa. Non-limiting terms are not to be construed as limiting unless expressly stated, or the context clearly indicates, otherwise (for example, “including,” “having,” and “comprising” typically indicate “including without limitation”). Singular forms, including in the claims, such as “a,” “an,” and “the” include the plural reference unless expressly stated, or the context clearly indicates, otherwise. [0086] The scope of the present physiologically acceptable anti-biofilm compositions, systems and methods, etc., includes both means plus function and step plus function concepts. However, claims are not to be interpreted as indicating a “means plus function” relationship unless the word “means” is specifically recited in a claim, and are to be interpreted as indicating a “means plus function” relationship where the word “means” is specifically recited in a claim. Similarly, claims are not to be interpreted as indicating a “step plus function” relationship unless the word “step” is specifically recited in a claim, and are to be interpreted as indicating a “step plus function” relationship where the word “step” is specifically recited in a claim. [0087] From the foregoing, it will be appreciated that, although specific embodiments have been discussed herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the discussion herein. Accordingly, the systems and methods, etc., include such modifications as well as all permutations and combinations of the subject matter set forth herein and are not limited except as by the appended claims or other claim having adequate support in the discussion herein.

1a

BACKGROUND OF THE INVENTION The present invention relates to a bone reaming device, and in particular to a bone reaming device having an ablation device with a variable geometry, which geometry is remotely modifiable. Surgeons are using minimally invasive surgical techniques on an increasing basis for the treatment of a wide variety of medical conditions. Such techniques typically involve the insertion of a surgical device through a natural body orifice or through a relatively small incision using a tube or cannula. In contrast, conventional surgical techniques typically involve a significantly larger incision and are therefore sometimes referred to as open surgery. Thus, as compared with conventional techniques, minimally invasive surgical techniques offer the advantages of minimizing trauma to healthy tissue, minimizing blood loss, reducing the risk of complications such as infection, and reducing recovery time. Further, certain minimally invasive surgical techniques can be performed under local anaesthesia or even, in some cases, without anaesthesia, and therefore enables surgeons to treat patients who would not tolerate the general anaesthesia required by conventional techniques. Surgical procedures often require the formation of a cavity within either soft or hard tissue, including bone. Tissue cavities are formed for a wide variety of reasons, such as for the removal of diseased tissue, for harvesting tissue in connection with a biopsy or autogenous transplant, and for implant fixation. To achieve the benefits associated with minimally invasive techniques, tissue cavities should be formed by creating only a relatively small access opening in the target tissue. An instrument or device then can be inserted through the opening and used to form a hollow cavity that is significantly larger than the access opening. Depending on the specific application, the shape of the desired cavity can be spherical, hemispherical or cylindrical, or any number of different combinations or variations of such shapes. A tissue cavitation device and method is, for example, known from US 2002/0183758 A1, describing a percutaneous surgical device and method for creating a cavity within tissue during a minimally invasive procedure. The cavitation device includes a shaft interconnected to a flexible cutting element. The flexible cutting element has a means to move toward a shape suitable for forming a cavity in tissue. Further, a surgical rotary abrader is known from US 2003/0083681 A1, describing an apparatus for use as a surgical hand piece including a body, a rotatable shaft extending from the body and including a tissue contacting component such as a burr, and an outer tube connected to the body and surrounding at least a portion of the shaft. However, presently known solutions for a reaming device lack of a capability of tracking particular forms of the cavity to be formed owing to the more or less fixed geometry of the head of such devices. SUMMARY OF THE INVENTION It may be seen as one aspect of the present invention to provide a reaming device being capable of tracking a particular form of a cavity to be formed, for example, to minimise the dimension of the cavity and to avoid collisions with obstacles, for example, implants. According to an exemplary embodiment of the invention, there is provided a reaming device comprising a first shaft, a head having a surface, which head is pivoted or rotatable with respect to the first shaft, an ablation device, the ablation device being axially movable with respect to the head and being capable of protruding at least partially beyond the surface of the head, wherein a protruding amount the ablation device protrudes beyond the surface of the head has the variable geometry and the geometry is remotely modifiable. Thus, it is possible to modify the geometry of the head of the reaming device during operation without the need to remove the total reaming device from the operation location. Owing the known structure and total geometry, the protruding geometry may be set without the need to monitor the present protruding geometry. If, for example, monitored by an imaging system like x-ray or computer tomography and the like, it is possible to modify the geometry of the ablation device in order to more exactly track a particular form of the cavity to be formed by the reaming device. It is further possible to avoid, for example, a collision of the rotating ablation device with an obstacle. An obstacle may be, for example, an implant, in particular an intramedullary nail. In particular, by modifying the geometry of the ablation device, it is possible to modify the diameter of the cavity without the need to modify, for example, the rotational speed of a head of a reaming device. According to an exemplary embodiment of the invention, the ablation device protrudes at least partially beyond the surface of the head with at least a lateral component. Thus, in particular, the radius of the cavity to be formed may be modified, so that it is possible to track a particular form of a tubular cavity. The rotational axis in this case may be substantially the longitudinal axis of the reaming device. According to an exemplary embodiment of the invention, the reaming device further comprises a second shaft, the second shaft being coupled to the head, wherein the second shaft being pivoted with respect to the first shaft and being capable of pivoted driving the head with respect to the first shaft. Thus, it is possible to remotely modify the geometry of the protruding amount of the ablation device protruding beyond the surface of the head. Further, it is possible to drive the head by a drive being located outside the head portion of the reaming device. In particular, the second shaft may be used for driving the head and the ablation device. However, instead of driving the head by the second shaft, it is possible to drive the head, for example, by a driving unit being located in the head of the reaming device. Such a drive may be, for example, a turbine placed close to the head, which may be driven by pressured air, so that the pressured air is let through the first shaft to drive the turbine. The pressured air after leaving the turbine may also be used for removing ablated tissue. According to an exemplary embodiment of the invention, the second shaft is substantially concentric within the first shaft. Thus, the outer surface of the shaft of the reaming device may be kept in a more or less constant position. In other words, when placing the second shaft within the first shaft, the first shaft may be kept fixed, wherein the second shaft may rotate to drive the head of the reaming device. Thus, vibrations and damages to the tissue surrounding the first shaft as an entry channel of the target tissue may be avoided. According to an exemplary embodiment of the invention, the reaming device further comprises a third shaft, the third shaft being coupled to the ablation device, wherein the third shaft being capable of modifying the variable geometry of the protruding amount of the ablation device protruding beyond the surface of the head. Thus, it is possible to remotely modify the geometry of the protruding amount of the ablation device by a shaft, so that the reaming device dimensions, in particular the diameter of the outer shell, may be kept low. According to an exemplary embodiment of the invention, the third shaft is substantially concentric within the second shaft. Thus, the second shaft may rotate, wherein the third shaft may be kept fixed in order to modify the geometry of the protruding amount. However, it is also possible to rotate the third shaft. By providing a second shaft and a third shaft, it is possible to divide the functions of driving the head with the ablation device and the modification of the geometry by having two different mechanical components. However, the driving of the head and the modification of the driving geometry each may be carried out by means of a micro turbine, as described above or an electric micro-drive, so that the second shaft and the third shaft, respectively, may be replaced by e.g. an electrical connection. Further, the second shaft may be omitted, in case the third shaft is used for both purposes at the same time, driving the head and for modifying the variable geometry. In this case, the connection between the head and the first shaft should be pivoted and non-positive and force-fit, respectively, in the axial direction. According to an exemplary embodiment of the invention, the reaming device comprises at least one ablation wire protruding at least partially beyond the surface of the head through a through-hole within the head, wherein the third shaft being coupled with the ablation device and being axially movable with respect to the head. Thus, it is possible to move the tip of an ablation wire to modify the geometry of the protruding amount. The protruding amount corresponds to the portion of the tip of the ablation wire, which extends beyond the surface of the head. When providing a flexible ablation wire, the geometry of the protruding amount and the radius of the operating area of the reaming device may be modified in order to track a particular diameter of a, for example, tubular cavity of varying diameter over the length formed by the reaming device. The tip of the ablation wire may be provided with a burr or an ablation tool in order to remove tissue. According to an exemplary embodiment of the invention, the ablation device comprises at least one ablation element protruding at least partially beyond the surface of the head through a through-hole within the head, wherein the third shaft being coupled with the ablation device via a gear to modify the variable geometry of the protruding amount protruding beyond the surface of the head. Thus, the ablation elements may be formed of a non-flexible material in order to provide a hard or rigid ablation element. Such rigid ablation elements are, for example, necessary if removing of hard tissue is desired, for example, within bones. According to an exemplary embodiment of the invention, the head comprises at least one recess, and the reaming device further comprises a conduit which conduit is connected via a first end to the recess to allow removal of ablated tissue. Thus, it is possible to remove tissue from the operating area of the reaming device head so that ablated tissue does not remain in the cavity. Further, it is possible to deliver particular materials through the conduit to the head of the reaming device, for example, pharmaceuticals for treating the area of the cavity formed by the reaming device. According to an exemplary embodiment of the invention, the conduit is formed by an inner wall of the first shaft and an outer wall of one out of the group consisting of the second shaft and the third shaft. Thus, the conduit may be formed as a concentric space between the shafts, so that no further conduit outside the first shaft needs to be provided. According to an exemplary embodiment of the invention, the head is pivoted around a longitudinal axis of the first shaft. Thus, the head may be formed very slim in order to introduce the head of the reaming device through a bore hole or channel to the location to be treated with the reaming device. According to an exemplary embodiment of the invention, the head is mounted on a first end of the first shaft, and a second end of the first shaft is mounted to a suction adapter. Thus, the removed ablated tissue may be sucked via the suction adapter, which suction adapter may be connected to a vacuum pump or the like. It should be noted that the above features may also be combined. The combination of the above features may also lead to synergetic effects, even if not explicitly described in detail. These and other aspects of the present invention will become apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS Exemplary embodiments of the present invention will be described in the following with reference to the following drawings. FIG. 1 illustrates a longitudinal cross-section of a reaming device according to an embodiment of the present invention; FIG. 2 illustrates a longitudinal cross-section of a head portion of a reaming device according to an embodiment of the present invention; FIG. 3 illustrates an exploded view of several components of the reaming device according to an embodiment of the invention; FIG. 4 illustrates a view of assembled components of a reaming device according to an embodiment of the invention; FIG. 5 illustrates an assembled head portion of a reaming device according to an embodiment of the invention; FIG. 6 illustrates the connection of the several shafts with the suction device according to an embodiment of the invention; FIG. 7 illustrates a perspective view of the suction device according to an embodiment of the invention; FIG. 8 illustrates a further embodiment including a gear arrangement within a head according to an embodiment of the invention; and FIG. 9 illustrates an assembled arrangement of the embodiment illustrated in FIG. 8 . DETAILED DESCRIPTION FIG. 1 illustrates a total view of the reaming device according to an exemplary embodiment of the invention. The reaming device has a head portion denoted with A, an operator portion denoted with B and a shaft portion between the head portion and the operator portion. The head portion will be inserted through an orifice or channel of the human body in order to remove or ablate tissue by means of ablation devices 50 . The operator portion denoted with B remains outside the human body in order to allow the operator to handle the reaming device. For example, it is possible to remove the ablated tissue by sucking on a suction adapter or a suction device 2 , when an operator handles the reaming device, in particular the shaft 30 for modifying the geometry of the protruding amount of an ablation device, which protrudes beyond an outer surface of a head portion 40 . The head 40 portion is mounted on to a first shaft 10 , in particular, the head is pivoted with respect to the first shaft 10 . In the shown embodiment, a second shaft 20 is provided concentrically within the first shaft in order to drive the head 40 . The head 40 is mounted to one end 18 of the first shaft 10 , and with a second end 19 of the first shaft 10 , the first shaft is mounted to the suction adapter 2 . Thus, a reaming device 1 may be provided, which allows an operator to modify the geometry of a protruding amount of an ablation device by means, for example, of a third shaft 30 . FIG. 2 illustrates a detailed picture of a longitudinal cross-section of the head 40 of the reaming device 1 . The head portion denoted with A comprises a first shaft 10 , a second shaft 20 being concentrically formed within the first shaft and a third shaft 30 provided concentrically within the second shaft 20 in the present embodiment. The head 40 may be mounted to the top portion 18 of the first shaft 10 by means of an adapter plug 102 , which may also serve as a gasket or seal. The ablation device 50 may comprise, for example, an ablation wire 51 , which protrudes with a protrusion a mount 55 beyond a surface 41 of the head 40 . The protrusion wire may extend through a hole or opening 42 being formed in the head 40 of the reaming device 1 . The head 40 may be pivoted or rotated around a longitudinal axis 13 of the shaft geometry, so that also the protruding amount 55 rotates in order to ablate tissue. The protruding amount 55 extends at least partially laterally in radial direction 56 with respect to the longitudinal axis 13 of the device. However, the protruding amount 55 may also extend partially in a longitudinal direction 57 , i.e. into the direction of the longitudinal axis 13 . Further, openings 42 , 43 may be provided in order to allow removal of ablated tissue. These openings 43 , 42 may be provided close to the ablation device 50 in order to allow removal of tissue immediately after ablating the tissue. The tissue may be removed by transporting the ablated tissue through the conduit 70 , wherein the conduit 70 is functionally connected with its first end 78 to the openings or recesses 42 , 43 to allow removal of the ablated tissue. The conduit may be formed by an inner wall 12 of the first shaft 10 and an outer wall 21 of second shaft 20 or may be formed by an inner wall 12 of the first shaft and an outer wall 31 of the third shaft 30 . The latter case is applicable in case there is no second shaft provided. The coupling of the second shaft to the head 40 may be provided via an adapter device 101 . FIG. 3 illustrates an exploded view of the reaming device 1 . The first shaft 10 is provided with the bearing, sealing and/or grommet device 102 . The second shaft 20 is connected to the adapter device 101 in order to provide a connection to the head 40 . Within the second shaft 20 , there is provided the third shaft 30 on top of which, a block 103 may be provided in order to provide a reliable positioning of the ablation device 50 . In the embodiment shown in FIG. 3 , the ablation device comprises two ablation wires 51 . The ablation wires, or in general, the ablation device 50 , will be inserted into the head 40 , so that the ablation wires 51 extend through the recesses or holes 42 . The recesses 42 and 43 will serve for removal of the ablated tissue. A detailed geometry can be seen from the longitudinal cross-section of FIG. 2 or the perspective view of FIG. 4 . It should be noted, that the number of ablation devices, e.g. ablation wires is not limited to the number of two, but may also be only one or alternatively more than two ablation devices. FIG. 4 illustrates a perspective view of the assembled head portion of the reaming device 1 . In the embodiment shown in FIG. 1 , the first shaft 10 is connected to the head 40 via the device 102 serving as a sealing, bearing, and/or grommet. The adapter device 101 connects the second shaft being provided concentrically within the first shaft 10 , to the head 40 . The ablation wires 51 extend beyond the surface 41 of the head 40 by a protruding amount 55 . The geometry of the protruding amount may be remotely modified by moving the third shaft 30 for example in longitudinal direction, so that when pushing the third shaft 30 , the protruding amount 55 of the protruding wires 51 will extend in a larger amount over the surface 41 of the head 40 . It should be noted that the modification may also be carried out by a relative rotating and a gear, e.g. a screw or worm gear (not shown). Recesses 43 allow removal of the ablated tissue. Therefore, the recesses 43 may be provided close to the protruding amount of the protruding wires 51 . The arrows illustrate the flow of the ablated tissue from the proximity of the ablation wire 51 through the head portion through the recesses or openings 43 into the conduit 70 . The conduit 70 is formed by the inner surface 12 of the first shaft 10 and the outer surface 21 of the second shaft 20 . It should be noted that also the holes 42 through which the ablation device is conducted may serve as a recess to remove tissue. It should be noted that the geometry of the ablation wires 51 may also be of a different geometry, in particular if modifying the tip geometry with respect to the requirements of the ablation application. FIG. 5 illustrates the head 40 with the ablation device 50 inserted into the holes 42 of the head 40 , here in form of ablation wires 51 . The ablation wires 51 extend at least partially in a lateral direction 56 beyond the surface of the head 40 , however they may also extend in a longitudinal direction 57 . The block 103 restricts the movement of the ablation device and constitutes the transit from the ablation wires 51 to the third shaft 30 . FIG. 6 illustrates a suction adapter 2 , which may be connected to the end portion 79 of the conduit 70 . The suction adapter 2 comprises, for example, a spout 105 to be connected to a vacuum pump, not shown. The second shaft may be connected to a drive, wherein the bushing may be sealed with a seal or grommet 104 . The third shaft 30 may be formed concentrically within the second shaft. The handling devices or the driving devices for the second shaft 20 and the third shaft 30 are not shown. FIG. 7 illustrates a perspective view of the suction adapter 2 of FIG. 6 . The end portion 79 of the conduit 70 is connected to the body of the suction adapter or suction device 2 , so that the ablated tissue may be removed by a suction process. The ablated tissue will move along the arrows through the spout 105 . The position of the second shaft 20 and a third shaft 30 may be fixed by a screw 106 . FIG. 8 illustrates an embodiment including a gear providing a connection between the ablation device and the third shaft, not shown in FIG. 8 . The ablation device shown in FIG. 8 comprises rigid or hard ablation tips or blades 52 , which are pivoted mounted by a hinge 54 so that the rotation of the ablation device 50 is not locked when hitting a rigid obstacle, for example, an implant or the like. The gear wheel portions 200 engage into recesses 202 of a rod 204 which may be moved in the longitudinal direction, and which may be directly connected to the third shaft for modifying the geometry (diameter) of the ablation device. It should be noted that the gear wheel portions rotate along an axis perpendicular to the longitudinal axis of the device when being operated by the third shaft, which third shaft being moved into longitudinal direction of the device, i.e. the shaft extension. The tips or blades 52 of the ablation device 50 may rotate around a hinge 54 , having a rotational axis being substantially parallel to the longitudinal axis of the device, if the device is in the position shown in FIG. 8 . However, the rotational axis of the hinges 54 may be inclined, when the geometry of the ablating device 50 will be modified by moving the rod with the recesses along a longitudinal axis of the device. Similar to the previous embodiments, there may be provided recesses or openings 43 in order to remove tissue to be transported through the conduit 70 . FIG. 9 illustrates the device of FIG. 8 when being assembled with a head 40 , so that the mechanical parts are covered to avoid injury of the surrounding tissue or to avoid damages of the mechanical components. It should be noted that the term ‘comprising’ does not exclude other elements or steps and the ‘a’ or ‘an’ does not exclude a plurality. Also elements described in association with different embodiments may be combined. It should be noted that the reference signs in the claims shall not be construed as limiting the scope of the claims. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable. BACKGROUND [0003] The disclosure relates generally to candy making devices used during the cooling and set-up of candy. Also disclosed are devices that are used to mix air into a candy body or pool, and more particularly, but not necessarily entirely, to a hand operated candy making device. [0004] Candy making is an age old occupation and various techniques have been used for hundreds of years. Candy can be based on many ingredients, and one such primary ingredient is sugar and its many derivatives, such as corn syrup. These sugar like bases can be cooked into a liquid state and then manipulated into a final product. Often such manipulation involves the introduction of flavors and colors into the mixture. As the candy mixture works its way toward becoming more solid, it can be increasingly difficult to work. Under such circumstances, currently available tools lack the strength to operate effectively. Wood tools can break or leave wood particles in the mixture. All metal tools can, and do, conduct heat away from the mixture toward the user. In many cases a user simply does not have a strong enough tool, or one correctly configured for the job at hand Round edges of spoons do poorly for effectively moving the body of candy mixture around a work surface. Spatulas either melt or flex to much as the candy hardens. [0005] The features and advantages of the disclosure will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by the practice of the disclosure without undue experimentation. The features and advantages of the disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out herein. SUMMARY OF THE DISCLOSURE [0006] An embodiment may comprise a use of an apparatus that comprises a blade portion made of substantially rigid material. Said blade portion may have a first scraping edge and a handle attachment structure. The apparatus may further comprise a first mixing plane opposing a second mixing plane and a second scraping edge and a third scraping edge disposed between said handle attachment structure and said first scraping edge. There may also be a handle portion having a length three times greater than said second scraping edge for leverage, and wherein said handle portion is attached to said blade portion by a plurality of fasteners and fastened through said handle attachment structure. The use of the apparatus may include scraping said blade along a mixing surface so as to push a plurality of portions of a candy body in a plurality of directions so as to mix air into said candy body and cool said candy body. The use may further comprise testing said candy body to determine the consistency of the candy body. [0007] An embodiment may further include using said apparatus to maintain a single candy body, or may include using said apparatus to divide a single candy body in to a plurality of candy bodies. Additionally, an embodiment may include scraping said first scraping edge along said mixing surface, and/or, a second scraping edge along said mixing surface. Consistent with the above, the use may further include scraping a third scraping edge along said mixing surface. The use of such an apparatus may further include adding a flavoring to said candy body and mixing in said flavoring with said apparatus. [0008] An embodiment may be formulated into a system including an apparatus consistent with the above, a mixing surface, and additional candy making ingredients. In various embodiments the mixing surface maybe made of stone, metal, wood, plastic or other suitable material. The system may further include blade attachments that would aid the apparatus in being used with various materials. Such blade attachments may protect the blade and surface alike. The blade attachments may further include attachment structures for attaching to the blade or may be simply friction fit. [0009] An embodiment may take the form of a kit wherein differing apparatuses may be included therein. For example, such a kit may comprise a large apparatus and a small apparatus, wherein the plurality of apparatuses may be used at differing portions of the candy making process. [0010] An embodiment consistent with the disclosure may include a blade portion made of substantially ridged material, wherein the blade portion has a first, second and third scraping edge. The blade portion may further include a protrusion or structure for attaching and handle thereto. The blade portion may also include first and second mixing planes for mixing candy thereby and thereon. The handle portion may be sized so as to be at least three times the length of the blade portion in order to provide adequate leverage for a user. Additionally, the blade portion may be attached to said handle portion with a plurality of fasteners to resist relative rotation between the components during use. An embodiment may include a handle attachment structure that protrudes into said handle. An embodiment may include a first scraping edge cover, wherein said cover is made of a different material than said blade portion. An embodiment may include a cover made of rubber or another polymeric material. An embodiment may include a handle that is made of wood, and wherein the handle has a contour therein for increased usability. An embodiment may comprise a handle that is made out of metallic material or a plastic material. An embodiment may have a blade portion made out of plastic, wood or metal. An embodiment may comprise a blade portion having a flexible tip or flexible tip covers. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The features and advantages of the disclosure will become apparent from a consideration of the subsequent detailed description presented in connection with the accompanying drawings in which: [0012] FIG. 1 is an illustration of an embodiment of the features of the disclosure and made in accordance with the teachings and principles of the disclosure; [0013] FIG. 2 is an illustration of an embodiment of a candy making device made in accordance with the teachings and principles of the disclosure; [0014] FIG. 3 is an illustration of an embodiment of a candy making apparatus made in accordance with the teachings and principles of the disclosure; [0015] FIG. 4 is an illustration of the use of an embodiment of an apparatus for making candy in accordance with the disclosure; [0016] FIG. 5 is an illustration of an embodiment of a candy making device made in accordance with the teachings and principles of the disclosure; [0017] FIG. 6 is an illustration of an embodiment of a candy making device made in accordance with the teachings and principles of the disclosure; [0018] FIG. 7 is an illustration of an embodiment of a candy making device made in accordance with the teachings and principles of the disclosure; [0019] FIG. 8 is an illustration of an embodiment of a candy making device made in accordance with the teachings and principles of the disclosure; and [0020] FIGS. 9 a - 9 f illustrate the use of a candy making apparatus made in accordance with the teachings and principles of the disclosure. DETAILED DESCRIPTION [0021] For the purposes of promoting an understanding of the principles in accordance with the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the disclosure as illustrated herein, which would normally occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the disclosure claimed. [0022] Before the devices, systems, methods and processes for aerating and mixing a candy body are disclosed and described, it is to be understood that this disclosure is not limited to the particular embodiments, configurations, or process steps disclosed herein as such embodiments, configurations, or process steps may vary somewhat. It is also to be understood that the terminology employed herein is used for the purpose of describing particular embodiments only and is not intended to be limiting since the scope of the disclosure will be limited only by the appended claims and equivalents thereof. [0023] In describing and claiming the subject matter of the disclosure, the following terminology will be used in accordance with the definitions set out below. [0024] It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. [0025] As used herein, the terms “comprising,” “including,” “containing,” “characterized by,” and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional, unrecited elements or method steps. [0026] As used herein, the phrase “consisting of” and grammatical equivalents thereof exclude any element, step, or ingredient not specified in the claim. [0027] As used herein, the phrase “consisting essentially of” and grammatical equivalents thereof limit the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic or characteristics of the claimed disclosure. [0028] With reference primarily to FIG. 1 , an embodiment of the features of the disclosure will be discussed generally. FIG. 1 illustrates a candy mixing apparatus 100 for use in making candy. The candy mixing apparatus 100 may comprise a blade portion 105 and a handle portion 110 . The blade portion 105 may be made of substantially rigid material such as a metal, plastic, or wood. The blade portion 105 may be attached to the handle portion 110 with fasteners 115 . The blade portion 105 may comprise additional structures that will be discussed in detail below. [0029] As can be further seen in FIG. 1 , the candy mixing apparatus 100 is interacting with a work surface 210 in order to manipulate and mix a body of candy mixture 150 . The work surface 210 may be made of marble, granite, stone, metal, wood, plastic or a combination thereof. As can be seen in the figure, as the candy mixing apparatus 100 is moved into the body of candy mixture 150 , the body of candy mixture 150 is manipulated from its resting state. Manipulating the candy mixture 150 may aid in the introduction of cooling air, coloring, flavorings or any manner of ingredients. An embodiment of the apparatus 100 may comprise a total length of said apparatus 100 that may be about 24.5 inches and may have a handle width of about 1 inch by about 1.5 inches. The embodiment may further comprise a paddle or blade portion 105 that may be about 4.5 inches in height by about 3.5 inches in width and may be made from metal or other sufficiently rigid material. The embodiment may range in total length from about 12 inches to about 24.5 inches. The embodiment may have a blade portion 105 that ranges from about 2 inches to about 4 inches in width and have a height that ranges from about 2 inches to about 5 inches. Embodiments of the handle portion 110 may range from about 1 inch by 1 inch to about 1 inch by 1.5 inches. [0030] Referring now to FIG. 2 , the blade portion 105 of the candy mixing apparatus 100 will be discussed in greater detail. As is illustrated in FIG. 2 , the blade portion 105 may consist of three working or scraping edges 107 , 108 , 109 , positioned at the edges of the blade portion 105 . During use, a user may employ all of the edges in the candy making process. For example, when maximum leverage is needed, scraping edge 108 may be employed to take advantage of the maximum leverage of the handle portion 110 . In other operations, side scraping edges 107 and 109 may be employed. [0031] As further can be seen in FIG. 2 , the blade portion 105 may be shorter than the handle portion 110 . In some embodiments, the ratio of handle length to blade length could exceed 3:1, and may have a range of values of about 2:1 to 6:1. Additionally, a user may choose to “choke” down on the handle portion 110 for quicker movement, much like a baseball player chokes down on a baseball bat. It may be further noted that the location of fasteners 115 , and type of fasteners 115 should be chosen with sufficient dimensions to handle the load placed thereon, such that the blade portion 105 does not move relative to the handle portion 110 . The blade portion 105 may further have a protrusion or attachment structure 116 for attaching the blade portion 105 to the handle portion 110 . It will be appreciated that the attachment structure 116 will mechanically interact with the handle portion 110 and fasteners 115 . [0032] Additionally, FIG. 2 illustrates two working planes, namely plane A and plane B, on the blade portion 105 . The working planes A and B structurally separate the scraping edges 107 , 108 , 109 , and operate in a manner to manipulate the candy mixture. [0033] Referring now to FIG. 3 , the handle portion 110 of the candy mixing apparatus 100 will be discussed. Illustrated in FIG. 3 is a side view of the candy mixing apparatus 100 . It should be noted that the drawings are not intended to be to scale, but are rather intended to best illustrate the features of the disclosure. The handle portion 110 may be constructed of wood or other suitable material. The choice of wood that may be chosen as the handle portion may include a rustic or other finish or qualities to provide an heirloom for an aesthetically pleasing device. Wood may also be chosen for its properties, such as rigidity, gripability, and workability. Other materials may be used as well such as metal or plastics. As can be seen in the figure, fasteners 115 may span the complete width of the candy mixing apparatus 100 . [0034] Additional fastening means are contemplated and are intended to fall within the scope of this disclosure. For example, bands around the handle 110 and blade 105 portions may hold the two together. Additionally, a quality glue may be used the hold the components together, and the fasteners may be of any known in the art today, or those yet to be develops. And finally, the fasteners may be recessed in the material of the associated handle portion 110 . [0035] Illustrated in FIG. 4 is an embodiment of use for the candy mixing apparatus 100 . As can be seen in the figure, a user may grasp the handle portion 110 comfortably and move the blade portion 105 into the body of candy mixture 150 on the work surface 210 . As stated above, a user may choose to “choke” down on the handle portion 110 for quicker movement, much like a baseball player chokes down on a baseball bat. [0036] Referring now to FIG. 5 , additional functionality of the apparatus 100 is shown from that of FIG. 4 . One of the advantages of providing a handle 110 as described herein, may be that it is of such a size that the user may grip the handle in varying hand holds or positions as additional leverage is needed or as fatigue sets in. As can be seen in FIG. 5 , the user has reversed the grip previously illustrated in FIG. 4 . The user has done this while doing a similar scraping action, but with the result of using a different set of muscles, which may aid in reducing fatigue. In FIG. 4 , the majority of the effort is being used to pull the tool or apparatus 100 toward the user. In contrast, the action of FIG. 5 is to push the tool or apparatus 100 away from the user. Such repeated motions with the disclosed candy mixing apparatus 100 can be used to manipulate the making of candy. [0037] Referring now to FIG. 6 , an embodiment of a candy mixing apparatus 300 is shown as having a blade portion 305 configuration wherein angles A and B are not ninety ( 90 ) degree angles. By changing the angles between the scraping edges, e.g., between the first scraping edge and the second and third scraping edge, of the blade portion 305 different user positions can be enabled. For example, where angle A is greater than ninety degrees, a user will be able to keep his/her hands further away from the material being worked. A flared blade portion 305 configuration provides differing scraping and leverage angles for various uses. It is within the scope of this disclosure to contemplate embodiments having angles greater than 90 degrees and less than 90 degrees. [0038] Illustrated in FIG. 7 is a side view of an embodiment of a candy mixing apparatus 400 . It should be noted that the drawings are not intended to be to scale, but are rather intended to best illustrate the features of the disclosure. The handle portion 410 may be constructed of wood or other suitable material. A choice of wood may be made for its rustic or heirloom qualities for an aesthetically pleasing device. Wood may also be chosen for its properties, such as rigidity, gripability, and workability. Other materials maybe used as well such as metal or plastics. As can be seen in the figure, fasteners 415 may span the complete width of the candy mixing apparatus 400 . [0039] Additional fastening means are contemplated and are intended to fall within the scope of this disclosure. For example, bands around the handle 410 and blade 405 portions may hold the two together. Additionally, a quality glue may be used the hold the components together, and the fasteners may be of any known in the art today, or those yet to be developed. And finally, the fasteners may be recessed in the material of the associated handle 410 . [0040] As is illustrated in FIG. 7 , the blade portion 405 may consist of three working or scraping edges positioned at the edges of the blade portion 405 . During use a user may employ all of the edges in the candy making process. For example, when maximum leverage is needed, the front scraping edge may be employed to take advantage of all of the leverage of the handle portion 410 . In other operations the side scraping edges may be employed. [0041] As further can be seen in FIG. 7 the blade portion 405 may be shorter than the handle portion 410 . In some embodiments the ratio of handle to blade length could exceed 3:1, and may have a range of values of about 2:1 to about 6:1. Additionally, a user may choose to “choke” down on the handle portion 410 for quicker movement, much like a baseball player chokes down on a baseball bat. It may be further noted that the location of fasteners 415 , and type of fasteners 415 should be chosen with sufficient dimensions to handle the load placed thereon, such that the blade portion 405 does not move relative to the handle portion 410 . The blade portion 405 may further have a protrusion or attachment structure 416 for attaching the blade portion 405 to the handle portion 410 . It will be appreciated that the attachment structure 416 will mechanically interact with the handle portion 410 and fasteners 415 . [0042] Additionally illustrated in the FIG. 7 are beveled or tapered profiles 419 for the edges of the blade 405 . The profile of the scraping edges may comprise a simple bevel, or may comprise a rounder profile. Such shaping of the blade edge may increase the scraping ability of the blade portion 405 as to various work surfaces. For example, a bevel profile may work well with a work surface such as stone, while another profile shape would work better with metal surfaces, while yet another would work better with wood or plastic surfaces. [0043] Illustrated in FIG. 8 is a front view of an embodiment of a candy mixing apparatus 500 . The candy mixing apparatus 500 may comprise a blade portion 505 and a handle portion 510 . The blade portion 505 may be made of substantially rigid material such as a metal, plastic, or wood. The blade portion 505 may be attached to the handle portion 510 with fasteners 515 . The blade portion 505 may comprise additional structures that will be discussed in detail below. [0044] As can be further seen in FIG. 8 , the candy mixing apparatus 500 is interacting with a work surface 580 in order to manipulate and mix a body of candy mixture 588 . The work surface 580 may be made of marble, granite, stone, metal, wood, and plastic. As can be seen in the figure, as the candy mixing apparatus 500 is moved into the body of candy mixture 588 , the body of candy mixture 588 is manipulated from its resting state. Manipulating the candy mixture 588 may aid in the introduction of cooling air, coloring, flavorings or any manner of ingredients. [0045] As stated above, various materials can be used for a work surface. Depending upon the work surface chosen, and to aid in the versatility of the candy mixing apparatus 500 , a cover 550 may be placed over an edge on the blade portion 505 for protecting the work surfaces and/or the blade edges. Such a cover may be attached to the blade portion 505 via a friction fit or may be attached with other attachment structures. The cover 550 may be made of plastic, nylon, rubber, wood, or any other material suitable for use with various working surfaces made from various materials. The cover 550 may provide a squeegee effect to aid in the mixing process. A plurality of covers 550 may be provided and used to increase the versatility of the candy mixing apparatus 500 . A kit may comprise a candy mixing apparatus 500 and may comprise a cover 550 . A kit may further comprise a plurality of covers 550 and another kit may comprise a plurality of candy mixing apparatuses 500 . [0046] Illustrated in FIGS. 9 a - 9 f is a method of using an apparatus for mixing candy consistent with the disclosure herein. As can be seen in FIG. 9 a , by a user placing one hand at the top of the handle, and placing the other hand at the bottom of the handle near the blade, a user can control the candy mixing apparatus with ease. As shown in FIG. 9 a a user can pull the blade portion toward themself, or in a reverse motion push material away from themself. [0047] As shown in FIG. 9 b , a user can use the palm of his/her upper hand to drive the blade portion to thereby scrape along a work surface. FIG. 9 c illustrates a use of the candy mixing apparatus wherein a user can pull the blade portion toward themself, or in a reverse motion push material away from themself. FIG. 9 d illustrates that a user can use the candy mixing apparatus laterally off to the side of the body. FIGS. 9 e - 9 f illustrate that the candy mixing apparatus can be used to scrape latterly across a work surface as a user progresses from the position of 9 e to the position of 9 f. [0048] During any of the above uses coloring or flavoring may be added to the body of candy along with other ingredients. By doing the steps illustrated and described above, a body of candy can be worked into the desired finished product. [0049] In the foregoing Detailed Description, various features of the disclosure are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description of the Disclosure by this reference, with each claim standing on its own as a separate embodiment of the disclosure. [0050] It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the disclosure. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of the disclosure and the appended claims are intended to cover such modifications and arrangements. Thus, while the disclosure has been shown in the drawings and described above with particularity and detail, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, variations in size, materials, shape, form, function and manner of operation, assembly and use may be made without departing from the principles and concepts set forth herein.

1a

This application is the US national phase of international application PCT/GB00/12353 filed 7, Dec. 2000, which designated the US. BACKGROUND OF THE INVENTION The invention relates to a mobile carriage, in particular embodied as a processing or a cleaning device which is suitable in particular for independent driving by the provision of at least one sensor device. Cleaning machines are known to a sufficient extent, for example, from international PCT application WO 98/43527 which was published before the priority date, on Oct. 8, 1998. The actual devices and components used for the floor cleaning in this case may comprise a bristle-containing roller or, for example, two interacting bristle-containing rollers, rotating about a horizontal axis, a circulating brush belt or, for example, one or more interacting brush disks, rotating about at least more or less vertical axes, or combinations of the above devices or the like. Also already disclosed are self-propelling processing machines and cleaning apparatuses which have corresponding sensor devices. Such sensor devices may comprise, for example, optical sensor devices using a laser beam for sensing purposes (for example in the horizontal plane) and/or ultrasonic sensors, radar sensors, or the like. In particular nowadays, use can even be made of sensors based on a camera with a silicon chip for evaluating the recorded image. In order for it to be possible to achieve corresponding good sensing of the surroundings and in respect of any existing obstacles, it has already been proposed to fit a total of 96 sensors in a wide range of different locations on a previously known processing machine. SUMMARY OF THE INVENTION The object of the present invention is thus to provide an improved sensor system which operates efficiently and effectively and is also of cost-effective construction. The carriage, which is preferably comparable with a robot and is preferably automatic, in particular in the form of a processing or cleaning machine, is distinguished in that, at least in dependence on the carriage traveling on a curved path or on an actuating, processing or cleaning unit, preferably in the form of a processing or cleaning head, provided on the vehicle pivoting, the at least one sensor device is pivoted along in unison at least in relative terms in the same direction. In a preferred embodiment, the pivoting operation may take place in direct correspondence with the angle deflection of the direction of travel or the rotation of the processing or cleaning head. This makes it possible to realize the essential advantage that, by virtue of the navigation devices pivoting along in unison, a considerably greater surrounding region may be covered, to be precise always in alignment with the critical region in which a movement takes place. This makes it possible to reduce drastically the number and cost of the sensor devices which are otherwise required. In a preferred embodiment, at least one sensor device, for example a laser sensor, is provided at floor level, in particular level with the running wheels or slightly above this, for example approximately level with a chassis or base of the processing device or of the cleaning machine. This sensor device may be a laser scanner which operates automatically over a horizontal angle range and senses the surroundings. Although this sensor, for example in the form of a laser scanner, already senses the surroundings over a wide-angle range from left to right (usually symmetrically in relation to the center longitudinal axis) when the carriage is traveling in a straight line, the solution according to the invention provides considerable advantages. The advantage according to the invention is manifested, in particular, when the carriage is traveling on a curved path or with the processing or cleaning head pivoting to a pronounced extent since, according to the invention, in this case the sensor is pivoted along in unison. This means that, from the outset, the sensed sensor field may be of comparatively small configuration and even certain lateral dead angles may be provided since, for example when the carriage is traveling to the left, the monitored and scanned region is then pivoted along in unison to the left, that is to say the lateral zones which otherwise, when the carriage is traveling in a straight line, are dead zones are also covered. Alternatively or as a supplement, according to the invention, at least one higher-level sensor device is, or preferably more than one higher-level sensor devices are, provided, the latter being arranged, for example, in front of the outer paneling of the automatic carriage or of the cleaning device. This sensor device may have a tree-like or column-like construction, which is coupled to the steering or pivoting device of the steering mechanism and/or of the pivotable processing or cleaning head. With the processing or cleaning head pivoting, it is also possible for this sensor device, i.e. for example the sensor column, to be pivoted along in unison and aligned in the running direction in each case. In a further modification of the invention, it is also possible, however, for this higher-level sensor device to be arranged beneath an outer paneling of the automatic processing or cleaning machine if at least parts of the covering behind which the critical sensor devices are seated are more or less “transparent” for said sensor device or window through-openings are provided at appropriate locations. The only essential factor is for it to be possible over a sufficient angle range, even beneath such an outer paneling of the processing or cleaning machine, for the corresponding sensor devices to be pivoted along in unison. The invention is described, in particular, for the case of a preferably self-propelling processing or floor-cleaning machine. It is also possible, however, for the invention to be used equally well for any mobile vehicle, in particular also a self-propelling vehicle. Possible examples of these also include lawnmowers, automatic lawn-sprinkling systems, agricultural machinery, road-cleaning or processing machines, snow plows, etc. There is no restriction to certain mobile vehicles or processing or cleaning machines. BRIEF DESCRIPTION OF THE DRAWINGS The invention is explained in more detail hereinbelow with reference to an exemplary embodiment. In the drawings, in specific terms: FIG. 1 : shows a simplified perspective illustration of a cleaning machine with a sensor device according to the invention which can be pivoted along in unison; FIG. 2 : shows a side view of the exemplary embodiment according to FIG. 1 ; FIG. 3 : shows a plan view of the exemplary embodiment according to FIGS. 1 and 2 ; FIG. 4 : shows a plan view which corresponds to FIG. 3 but with the carriage traveling on a curved path to the left rather than straight ahead; and FIG. 5 : shows a partly schematic side illustration for the purpose of explaining that the sensor device and the sensor tree may also be designed as a tactile sensor element and/or an additional sensor element, in particular tactile sensor element, may be provided for the purpose of sensing the floor. DETAILED DESCRIPTION OF THE INVENTION FIGS. 1 to 4 show exemplary embodiments of a floor-treating or floor-cleaning machine which, in terms of basic construction, corresponds to the floor-cleaning machine which is known from international PCT application WO 98/43527, which was published before the priority date. The floor-cleaning machine of such a construction has a treating head 3 which can be pivoted about a vertical axis, it further being possible for the cleaning head to be pivoted jointly about the vertical pivoting axis via a running roller 5 which can be pivoted along in unison. The vertical pivoting axis is preferably offset in relation to the vertical diameter through the running roller which can be pivoted along in unison. As far as the construction and functioning of such cleaning machines are concerned, you are referred to the abovementioned prior publication WO 98/43527 in full, and this is included in the contents of the present application. Insofar as the functioning and construction have been described in this prior publication, it is possible to omit such a description here. In order to configure, for example, a floor-treating machine known from the abovementioned prior publication as an automatic machine, it is possible, then, to provide the corresponding electrics and electronics for moving the floor-treating machine in accordance with a predetermined path or path region. In practice, however, such an automatic floor-treating machine may only be used expediently if it can react independently to obstacles in the cleaning region. This requires such obstacles to be detected first of all. Such obstacles may be, for example, in the form of people standing in the cleaning region or in the form of objects which, for example, have been newly placed in position, placed at some other location or displaced, etc. In order always to monitor such obstacles, and/or the boundary of the treating or cleaning surface, automatically and to be able to evaluate the same electronically, the floor-treating machine according to FIGS. 1 to 4 comprises a first, bottom sensor device 13 , which may comprise, for example, a laser scanner. The figures show here, on the one hand, the sensor device 13 as well as an associated sensing field 15 , along which the laser beam is moved back and forth permanently and automatically by way of the laser scanner. Within these fields it is possible, within a certain spacing, for the actual sensor 13 to detect, by the evaluation of the reflected light, whether obstacles are located in this region. It is just as possible, however, to use a different sensor device, for example a sensor based on a radar unit, an infrared unit, ultrasonic sensors, etc. It is also possible, however, to use a camera in order to analyze a corresponding picked-up optical image, by way of possible electronic evaluation methods which are already known nowadays, and to check for the presence of boundaries or obstacles and, in dependence thereon, to change, or at least influence, the continued travel, the travel in a straight line or the travel on a curved path of the automatic cleaning machine. Also provided is a second sensor device 17 , which, in the exemplary embodiment shown, is arranged above the first sensor device 13 . The second sensor device comprises a column-like construction with a multiplicity of sensor devices 23 , for example in the form of ultrasonic sensor devices 23 , formed there and seated, for example, one above the other on the mutually opposite side regions 19 and in the front region 21 . Whilst the first sensor device is preferably arranged directly above the floor region, for example level with the running wheels 5 and 7 or, for example, level with the chassis 25 of the processing or floor-treating machine, the so-called second sensor device 17 is preferably arranged above the chassis 25 , that is to say above the floor surface, in the exemplary embodiment shown above the running wheels 7 , and extends there, when the carriage is traveling in a straight line, in the center longitudinal plane of symmetry, the plurality of sensors 13 , arranged on the front and on the mutually opposite sides 19 , being arranged to a more or less pronounced extent vertically one above the other, in the exemplary embodiment shown on a type of sensor column 27 . This sensor column 27 is likewise firmly connected to the treating or cleaning head, in turn, such that it can be pivoted along in unison, in the exemplary embodiment shown it is mounted directly on top of the first sensor device 13 , with the result that, when the carriage is correspondingly traveling on a curved path or with the processing or cleaning head 3 pivoting, the first and second sensor devices are automatically aligned in the direction of cleaning and travel. The overall construction is thus such that, by means of a vertical pivoting axis arranged beneath the chassis 25 , the processing or floor-treating head 3 can be pivoted from left to right, it being the case that, when the carriage is traveling in a straight line, said pivoting head projects beyond the front boundary 29 ( FIG. 2 ) and the abovementioned second sensor device 17 is retained and mounted on said projecting sensor-carrying section 31 . The arrangement including the front housing covering 33 of the floor-treating machine is such that, even with lateral pivoting, said second sensor device 17 , for example in the form of the sensor column 27 , is no longer able to collide with the housing covering 33 . In the case of the plan view according to FIG. 4 , it is possible to see, in the case of the corresponding pivoting movement to the left, the first sensor device 13 pivoting along in unison, with the corresponding alignment of the sensing field 15 , and the second sensor device 17 , formed on the sensor column 27 , jointly pivoting along in unison. Since, by virtue of this technical measure, the critical region is always sensed and evaluated, it is possible for the number of individual sensor elements to be drastically reduced in comparison with conventional sensor devices. FIG. 5 corresponds to the lateral illustration according to FIG. 4 . It is further provided in the case of FIG. 5 that the sensor device 13 , 17 acts overall as a tactile sensor element 41 . In other words, if the mobile carriage, for example in the form of the floor-cleaning machine explained, runs into an object which, for example, also projects above the floor in the direction of the machine, it is possible either for the upwardly projecting sensor tree in the form of the second sensor device 17 or else also for the first, bottom sensor device 13 —as a result of the fact that the two units are designed together or separately as tactile sensor devices 41 —to initiate a corresponding signal, upon contact with relevant objects, in order to stop further travel in the forward direction and, if required, to move, for example, some way back again and then to the side, in particular when the carriage is a self-propelling vehicle. Alternatively or as a supplement, it is also possible to provide a further sensor device 141 , in particular in the form of a tactile sensor device 141 ′, which, in the exemplary embodiment shown in FIG. 5 , comprises a bar-like contact device 45 which projects in the forward and downward directions and is provided at the bottom with a roller or after a contact section 45 ′ tilted down counter to the direction of travel. If the vehicle explained above, for example in the form of a floor-cleaning machine, moves toward downwardly directed stairs, then this floor-sensor device 141 , in particular in the form of a tactile sensor device 141 , would immediately detect that the floor surface terminates at a step or a drop and would bring the vehicle to a standstill or initiate, if required, a change in direction to the side or to the rear or a correspondingly superposed movement. It is thus possible to prevent the vehicle from tumbling downward, for example, on stairs or ramps.

1a

This application is a Continuation of application Ser. No. 08/350,188, filed on Nov. 30, 1994, now abandoned, which is a Continuation of application Ser. No. 08/197,453, filed on Feb. 16, 1994, abandoned, which is a Continuation of application Ser. No. 08/037,359, filed on Mar. 26, 1993, abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for treating cardiovascular disorders by administering L-carnitine, an acyl L-carnitine, or a pharmacologically acceptable salt thereof in combination with an ACE-inhibitor. The present invention also relates to orally, parenterally, rectally, or transdermally administrable pharmaceutical compositions suitable for treating cardiovascular disorders, which comprise, as active ingredients, L-carnitine, an acyl L-carnitine, or a pharmacologically acceptable salt thereof and an ACE-inhibitor. 2. Discussion of the Background Previous therapeutical uses of L-carnitine are already known. For instance, L-carnitine has been used in the cardiovascular field in the treatment of acute and chronic myocardial ischemia, angina pectoris, cardiac arrhythmias and cardiac insufficiency. In nephrology, L-carnitine has been administered to chronic uremic patients who are subjected to regular hemodialysis treatment with a view to counteracting muscular asthenia and the onset of muscular cramps. Further therapeutic uses are the restoration of the HDL/LDL+VLDL ratio to normal and in total parenteral nutrition. The use of L-carnitine for the treatment of certain myopathies and muscular dystrophies is also known. The ACE-inhibitors form a class of medicaments that has been recently introduced and are capable of preventing the conversion of angiotensin I into angiotensin II, with a consequent anti-hypertensive effect. Typical ACE-inhibitors include: captopril, enalapril, lisinopril, ramipril, fosinopril, zofenopril, pivopril, rentiapril, quinapril, indolapril, spirapril, pentopril, benazepril, libenzapril, cilazapril, delapril and perindopril. The main indications for which ACE-inhibitors are used are essential hypertension and renovascular hypertension. Recently, combination preparations of ACE-inhibitors with various types of other medicaments have been proposed for the treatment of diverse pathological conditions. Examples of such combination preparations and the relative therapeutic indications are set out in Table 1. TABLE 1______________________________________Known combination preparations ofACE-inhibitors with other medicamentsMedicaments Indications Reference______________________________________Captopril + diltiazem hypertension US 4,871,731ACE-inhibitors + calcium loss of cognitive EP 0 344 995antagonists functions, Alzheimer, senile dementiaACE-inhibitors + myocardiac post- EP 0 366 033thrombolitics ischaemia disfunctionACE-inhibitor + lithium depression US 4,912,096ACE-inhibitors + calcium medicament addiction EP 381 075antagonistsACE-inhibitors + calcium appetite suppression EP 381 074antagonistsACE-inhibitor + flosequinam cardiopathies WO 90/10445 myocardiac infarction______________________________________ The combinations set out above, particularly if used in the cardiovascular field, do not appear to be wholly satisfactory in that it is foreseeable that the improved therapeutic activity would be accompanied by at least the sum of the side effects of the ACE-inhibitors themselves on the one hand and on the other hand the side effects of the medicaments combined with them. In particular, in the case of the compositions containing calcium antagonists, side effects caused by excessive peripheral vasodilatation with consequent tachycardial reflex effects are to be expected. With regard to the use of acyl carnitines in combination with other medicaments, U.S. Pat. No. 4,537,772 discloses combinations of acyl carnitines (in which the acyl group can be saturated C 2 -C 20 acyl, C 2 -C 20 acyl with 1-6 double bonds, C 2 -C 20 hydroxyacyl with 1-3 hydroxyl groups, C 4 -C 20 ketoacyl, unsaturated C 5 -C 20 hydroxyacyl or C 5 -C 20 carbalkoxyacyl) and their pharmacologically acceptable salts in combination with various classes of medicaments, such as beta-lactamase antibiotics, aminoglycosidic antibiotics, antiviral agents, amino acids, relaxing agents for the smooth musculature, polypeptides, anti-inflammatory agents and diuretics. The only example supplied in U.S. Pat. No. 4,537,772 of combination between an acyl carnitine and a medicament with cardiovascular anti-hypertensive action is a combination of palmitoyl carnitine chloride and methyl dopa. The effect foreseen in U.S. Pat. No. 4,537,772 consists of improved gastrointestinal absorption (induced by the presence of the acyl carnitine) of a medicament which is poorly absorbed when administered on its own by the oral or rectal route. It is clear that there is no correlation between the use of acyl carnitines described in U.S. Pat. No. 4,537,772 and that which forms the subject of the present invention. Thus, there remains a need for a method to treat cardiovascular disorders. There also remains a need for pharmaceutical compositions useful for treating cardiovascular disorders. SUMMARY OF THE INVENTION Accordingly, it is one object of the present invention to provide a method for treating cardiovascular disorders. It is another object of the present invention to provide a method of treating cardiovascular disorders which has a low occurrence of side effects. It is another object of the present invention to provide novel pharmaceutical compositions for treating cardiovascular disorders. It is another object of the present invention to provide pharmaceutical compositions which exhibit a low tendency to case side effects. These and other objects, which will become apparent during the following detailed description, have been achieved by the inventor's discovery that the combination of (a) L-carnitine, an acyl L-carnitine, or a pharmacologically acceptable salt thereof with (b) an ACE-inhibitor offers significant advantages over previously available medicaments for treating cardiovascular disorders, such as ischemia, infarction, angina, hypertension, and congestive heart failure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Thus, in a first embodiment, the present invention provides pharmaceutical compositions comprising (a) L-carnitine, an acyl L-carnitine, or a pharmacologically acceptable salt thereof, and (b) an ACE-inhibitor as the active ingredients and a pharmacologically acceptable carrier or excipient. These compositions are suitable for oral, parenteral, rectal or topical (transdermal) administration. The acyl L-carnitines useful for the pharmaceutical compositions and methods of the present invention are those wherein the acyl group is a straight or branched-chain alkanoyl group having from 2 to 8 carbon atoms, preferably from 2 to 6 carbon atoms. Particularly preferred are acetyl, propionyl, butyryl, valeryl and isovaleryl L-carnitines. Pharmaceutically acceptable salts of L-carnitine include all pharmaceutically acceptable salts which are prepared by the addition of an acid to L-carnitine, and which do not give rise to undesired toxic or side effects. The formation of pharmaceutically acceptable acid addition salts is well known in pharmaceutical technology. Non-limiting examples of suitable salts include the chloride, bromide, orotate, acid aspartate, acid citrate, acid phosphate, fumarate, acid fumarate, lactate, maleate, acid maleate, acid oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate salts. Other suitably acceptable salts which are nontoxic and provide substantially similar results to administration of L-carnitine and the above-identified pharmaceutical salts will be readily apparent to one having ordinary skill in the art and are considered to be equivalent to the salts enumerated above. For the sake of simplicity and clarity, hereinbelow reference will be made to L-carnitine only, it being understood, however, that whatever is disclosed in connection with L-carnitine equally applies to the above-identified acyl L-carnitine and pharmacologically acceptable salts thereof. Suitable ACE-inhibitors include captopril, enalapril, lisinopril, ramipril, fosinopril, zofenopril, pivopril, rentiapril, quinapril, indolapril, spirapril, pentopril, benazepril, libenzapril, cilazapril, delapril and perindopril. The compositions of the invention suitably contain from 1 to 90% by weight, preferably 25 to 75% by weight, based on the total weight of the composition, of an ACE-inhibitor and from 1 to 90% by weight, preferably 25 to 75% by weight, based on the total weight of the composition, of L-carnitine. Unit dosage forms will preferably contain from 0.5 g to 2 g of L-carnitine, while the quantity of ACE-inhibitor will depend on the characteristics of this component. For example, with specific reference to ACE-inhibitors already approved for clinical use, ramipril may be present in quantities from 1 to 10 mg, enalapril from 5 to 50 mg, captopril from 10 to 100 mg, and lisinopril from 5 to 50 mg. The composition of the present invention may also be in the form of separate dosage units for simultaneous, separate or sequential use. In particular, compositions comprising about 1 g of L-carnitine and from 5 to 20 mg of lisinopril are preferred, for administration once per day. Using other ACE-inhibitors having different pharmacological characteristics (such as captopril), the compositions of the invention will preferably be administered two or more times per day, up to a daily dosage of 2-3 g of L-carnitine and 20-300 mg of ACE-inhibitor. Suitable forms of administration include capsules, tablets, syrups, granules, ampoules or phials, suppositories, or aqueous or oleous solutions. The compositions of the invention can be prepared by resorting to conventional processes and excipients, such as are described in Remington's Pharmaceutical Sciences Handbook, Mack Pub. Co., New York, USA, XVIII Ed., 1984. In another embodiment, the present invention provides a method for treating cardiovascular disorders by administering: (a) L-carnitine, an acyl L-carnitine, or a pharmacologically acceptable salt thereof, and (b) an ACE-inhibitor to a patient in need thereof. As noted above, the cardiovascular disorders which may be treated by the present method include ischemia, infarction, angina, hypertension, and congestive heart failure. The present method may be carried out by oral, parenteral, rectal, or transdermal administration. Oral administration is obviously preferred for chronic pathologies, while the parenteral route may be preferable for acute pathologies, for example in the case of an infarction. Although the exact dosage ranges of (a) L-carnitine, acyl L-carnitine, or pharmacologically acceptable salt thereof and (b) the ACE-inhibitor will vary according to the exact condition being treated and the state of the patient being treated, typically, the method will comprise administering about 0.5 to 3 g, preferably about 1 to 2 g, of L-carnitine (or an equimolar amount of the acyl L-carnitine or salt thereof) daily and about 1 to 500 mg, preferably about 5 to 100 mg of the ACE-inhibitor daily. As discussed above, the dosage range of the ACE-inhibitor may be adjusted based on the exact identity of the ACE-inhibitor. Other features of the invention will become apparent in the course of the following descriptions of exemplary embodiments which are given for illustration of the invention and are not intended to be limiting thereof. EXAMPLES Set out below are the results of certain clinical trials which demonstrate the advantages obtained by the present invention. Clinical Trials 25 patients suffering from congestive heart failure as a result of coronary pathologies or of ischemia of the myocardium, who had already been treated without appreciable therapeutic response with diuretics and an ACE-inhibitor (captopril) for periods longer than 30 days, were given lisinopril (4 mg) and L-carnitine (1 g) for 15 days. At the end of the treatment, 23 patients had a hemodynamic profile that was distinctly better, characterized by a reduction of systemic vascular resistance, an increase in contractility and cardiac output not accompanied by an increase in cardiac frequency, and a reduction in arterial pressure. Only two patients did not show significant improvements but the preliminary data indicated that extension of the period of treatment would have produced beneficial effects even in these non-responders. In none of the patients were toxic effects or side effects noted that could be attributed to the pharmacological treatment. The results set out above show clearly that L-carnitine is able to contribute markedly to treatment with ACE-inhibitors of non-responder patients, without a need to increase the dosage. Compositions The following examples illustrate some typical compositions of the present invention. Example 1 ______________________________________TABLETS______________________________________Lisinopril 5 mgL-carnitine 100 mgmicrocrystalline cellulose 250 mgmagnesium stearate 20 mglactose 100 mg______________________________________ Example 2 ______________________________________CAPSULES______________________________________ enalapril 10 mg L-carnitine 750 mg lactose 250 mg______________________________________ Example 3 ______________________________________CAPSULES______________________________________ captopril 50 mg L-carnitine 1000 mg lactose 500 mg______________________________________ Example 4 ______________________________________TABLETS______________________________________ramipril 5 mgL-carnitine 350 mgstarch 40 mggelatin 10 mgmicrocrystalline cellulose 20 mgmagnesium stearate 5 mg______________________________________ Obviously, numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is based on U.S. Provisional Patent Application Ser. No. 60/645,677 filed on Jan. 21, 2005 and entitled “THORASCOPIC HEART VALVE REPAIR METHOD AND APPARATUS.” BACKGROUND OF THE INVENTION [0002] Various types of surgical procedures are currently performed to investigate, diagnose, and treat diseases of the heart and the great vessels of the thorax. Such procedures include repair and replacement of mitral, aortic, and other heart valves, repair of atrial and ventricular septal defects, pulmonary thrombectomy, treatment of aneurysms, electrophysiological mapping and ablation of the myocardium, and other procedures in which interventional devices are introduced into the interior of the heart or a great vessel. [0003] Using current techniques, many of these procedures require a gross thoracotomy, usually in the form of a median sternotomy, to gain access into the patient's thoracic cavity. A saw or other cutting instrument is used to cut the sternum longitudinally, allowing two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening into the thoracic cavity is thus created, through which the surgical team may directly visualize and operate upon the heart and other thoracic contents. [0004] Surgical intervention within the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system, and arrest of cardiac function. Usually, the heart is isolated from the arterial system by introducing an external aortic cross-clamp through a sternotomy and applying it to the aorta between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the aortic root, so as to arrest cardiac function. In some cases, cardioplegic fluid is injected into the coronary sinus for retrograde perfusion of the myocardium. The patient is placed on cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood. [0005] Of particular interest to the present invention are intracardiac procedures for surgical treatment of heart valves, especially the mitral and aortic valves. According to recent estimates, more than 79,000 patients are diagnosed with aortic and mitral valve disease in U.S. hospitals each year. More than 49,000 mitral valve or aortic valve replacement procedures are performed annually in the U.S., along with a significant number of heart valve repair procedures. [0006] Various surgical techniques may be used to repair a diseased or damaged valve, including annuloplasty (contracting the valve annulus), quadrangular resection (narrowing the valve leaflets), commissurotomy (cutting the valve commissures to separate the valve leaflets), shortening mitral or tricuspid valve chordae tendonae, reattachment of severed mitral or tricuspid valve chordae tendonae or papillary muscle tissue, and decalcification of valve and annulus tissue. Alternatively, the valve may be replaced, by excising the valve leaflets of the natural valve, and securing a replacement valve in the valve position, usually by suturing the replacement valve to the natural valve annulus. Various types of replacement valves are in current use, including mechanical and biological prostheses, homografts, and allografts, as described in Bodnar and Frater, Replacement Cardiac Valves 1-357 (1991), which is incorporated herein by reference. A comprehensive discussion of heart valve diseases and the surgical treatment thereof is found in Kirklin and Barratt-Boyes, Cardiac Surgery 323-459 (1986), the complete disclosure of which is incorporated herein by reference. [0007] The mitral valve, located between the left atrium and left ventricle of the heart, is most easily reached through the wall of the left atrium, which normally resides on the posterior side of the heart, opposite the side of the heart that is exposed by a median sternotomy. Therefore, to access the mitral valve via a sternotomy, the heart is rotated to bring the left atrium into a position accessible through the sternotomy. An opening, or atriotomy, is then made in the left atrium, anterior to the right pulmonary veins. The atriotomy is retracted by means of sutures or a retraction device, exposing the mitral valve directly posterior to the atriotomy. One of the fore mentioned techniques may then be used to repair or replace the valve. [0008] An alternative technique for mitral valve access may be used when a median sternotomy and/or rotational manipulation of the heart are undesirable. In this technique, a large incision is made in the right lateral side of the chest, usually in the region of the fifth intercostal space. One or more ribs may be removed from the patient, and other ribs near the incision are retracted outward to create a large opening into the thoracic cavity. The left atrium is then exposed on the posterior side of the heart, and an atriotomy is formed in the wall of the left atrium, through which the mitral valve may be accessed for repair or replacement. [0009] Using such open-chest techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of a replacement valve through the atriotomy for attachment within the heart. However, these invasive, open-chest procedures produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of current techniques. [0010] The mitral and tricuspid valves inside the human heart include an orifice (annulus), two (for the mitral) or three (for the tricuspid) leaflets and a subvalvular apparatus. The subvalvular apparatus includes multiple chordae tendinae, which connect the mobile valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or elongation of the chordae tendinae result in partial or generalized leaflet prolapse, which causes mitral (or tricuspid) valve regurgitation. A commonly used technique to surgically correct mitral valve regurgitation is the implantation of artificial chordae (usually 4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the valve and the papillary muscle. This operation is generally carried out through a median sternotomy and requires cardiopulmonary bypass with aortic cross-clamp and cardioplegic arrest of the heart. SUMMARY OF THE INVENTION [0011] The present invention is a method and apparatus for performing a minimally invasive thoracoscopic repair of heart valves while the heart is beating. More specifically the method includes inserting an instrument through the subject's chest wall and through the heart wall. The instrument carries on its distal end a movable element which is manipulated to grasp a valve leaflet and hold it while a needle mechanism punctures the valve leaflet and loops a suture around a portion of the valve leaflet. The instrument is withdrawn from the heart along with the suture and the suture is tied off at the apex of the heart after adjusting its tension for optimal valve operation as observed with an ultrasonic imaging system. [0012] In addition to grasping and needle mechanisms, the instrument includes fiber optics which provide direct visual indication that the valve leaflet is properly grasped. A set of illuminating fibers terminate at the distal end of the instrument around the needle mechanism in close proximity to a set of sensor fibers. The sensor fibers convey light from the distal end of the instrument to produce an image for the operator. When a valve leaflet is properly grasped, light from the illuminating fibers is reflected off the leaflet surface back through the sensor fibers. On the other hand, if the valve leaflet is not properly grasped the sensor fibers see blood. [0013] A general object of the invention is to provide an instrument and procedure which enables heart valves to be repaired without the need for open heart surgery. The instrument is inserted through an opening in the chest wall and into a heart chamber while the heart is beating. The instrument enables repair of a heart valve, after which it is withdrawn from the heart and the chest. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0014] Under general anesthesia and double-lumen ventilation, the patient is prepped and draped so as to allow ample surgical access to the right lateral, anterior and left lateral chest wall (from the posterior axillary line on one side to the posterior axillary line on the other side). As shown in FIG. 1 , one or more thoracoscopic ports are inserted in the left chest through the intercostal spaces and an instrument 10 is inserted through one of these ports into the chest cavity. Alternatively, a small (3-5 cm) left thoracotomy is performed in the fifth or sixth intercostals space on the anterior axillary line. The patient is fully heparinized. After collapsing the left lung, the pericardium overlying the apex 12 of the left ventricle 14 is opened and its edges are suspended to the skin incision line. This provides close access to the apex of the heart. Guidance of the intracardiac procedure is provided by a combination of transesophageal or intravascular echocardiography (not shown in the drawings) and with direct visualization through a fiber-optical system built into the instrument 10 as will be described in detail below. A double-pledgeted purse-string suture is placed on the apex of the left ventricle 12 and a stab incision is made at that location. The surgical instrument 10 is inserted through this incision, into the left ventricular chamber 14 of the beating heart. [0015] Referring particularly to FIG. 2 , the instrument 10 may be used to grasp a prolapsing segment of the mitral valve 16 and an artificial chorda 18 may be secured to its free edge. Accurate positioning of the implanted artificial chorda 18 is guaranteed by both echo and direct fiberoptic visualization as will be described in detail below. The instrument 10 is then withdrawn from the left ventricle chamber 14 pulling the unattached end of the neo-implanted chorda 18 with it. Hemostasis is achieved by tying the purse-string suture around the incision in the left ventricular apex 12 after the instrument 10 and chorda 18 are withdrawn. As shown in FIG. 3 , the neo-implanted chorda 18 is appropriately tensioned under direct echo-Doppler visualization and secured outside the apex 12 of the heart. That is, a tension is placed on the neo-implanted chorda 18 and the operation of the repaired valve 16 is observed on the ultrasound image. The tension is adjusted until regurgitation is minimized. [0016] While a single chorda 18 is implanted in the above description, additional chorda, or sutures, can be implanted and attached to the apex 12 of the heart wall with optimal tension. In this case the tensions in all the neo-implanted chorda 18 are adjusted until optimal valve operation is achieved. [0017] As shown in FIGS. 4 and 5 , the instrument 10 used to perform the above procedure includes a rigid metal shaft 100 having a handle 120 at its extrathoracic (proximal) end which enables the instrument to be manipulated and guided into position. Actuating mechanisms for controlling the grasping mechanism and needle mechanism located at the distal end 140 of the instrument are also mounted near the handle 120 . As will be described below, the grasping mechanism is operated by squeezing the scissor-grip handle 120 , and the needle mechanism is operated by moving an up-turned control shaft 122 . [0018] Located on the distal, intracardiac end 140 of the instrument 10 is a grasping mechanism which can be operated to hold a prolapsing valve leaflet. As shown in FIGS. 6 and 7 , in the preferred embodiment this mechanism is a tip 160 which is supported on the distal end of the shaft 100 by a set of rods 162 . The rods 162 slide within the shaft 100 to move the tip 160 between an open position as shown in FIGS. 6B and 7 and a closed position as shown in FIG. 6A when the scissor-grip handle 120 is operated. As will be explained below, a mitral valve leaflet is located in the gap between the open tip 160 and the distal end of shaft 100 and it is captured by closing the tip 160 to pinch the valve leaflet therebetween. [0019] Disposed in a needle lumen 164 formed in the shaft 100 is a needle 180 which connects to the control shaft 122 at the proximal end of shaft 100 . Needle mechanism 180 slides between a retracted position in which it is housed in the lumen 164 near the distal end of the shaft 100 and an extended position in which it extends into the sliding tip 160 when the tip is in its closed position. As a result, if a valve leaflet has been captured between the tip 160 and the distal end of shaft 100 the needle may be extended from the lumen 164 by moving control shaft 122 to puncture the captured leaflet and pass completely through it. [0020] The distal end of the shaft 100 also contains an artificial chorda, or suture 18 that is to be deployed in the patient's heart. The suture 18 is typically a 4-0 or 5-0 suture manufactured by a company such as Gore-Tex. This suture 18 is deployed by the operation of the grasping mechanism and the needle mechanism 180 as described in more detail below. [0021] The shaft 100 has a size and shape suitable to be inserted into the patient's chest and through the left ventricle cardiac wall and form a water-tight seal with the heart muscle. It has a circular or ellipsoidal cross-section and it houses the control links between the handle end and the intracardiac end of the instrument as well as a fiber optic visualization system described in more detail below. [0022] As shown in FIGS. 8A-8F , the preferred embodiment of the suture deployment system at the distal end of the instrument 10 is positioned around a valve leaflet 16 to be repaired as shown in FIG. 8A . The suture 18 is folded at the middle to form a loop 19 that is positioned in the tip 160 . Both ends of the suture 18 are disposed in a suture lumen 165 formed in the shaft 100 beneath the rods 162 . As shown in FIG. 8B , the valve leaflet 16 is grasped by closing the tip 160 , and the needle 180 is extended to puncture the leaflet 16 and extend into the tip 160 . A notch 166 formed on one side of the needle 180 hooks the suture loop 19 . The needle 180 is then retracted back through the leaflet 16 to pull the suture loop 19 through the puncture opening as shown in FIG. 8C . The leaflet 16 is then released and the instrument 10 is withdrawn from the heart as shown in FIG. 8D pulling both ends and the midpoint of the suture 18 with it. As shown in FIG. 8E , the suture 18 is released by the instrument 10 and the surgeon inserts the two suture ends 21 through the loop 19 at its midpoint. The ends 21 are then pulled and the loop 19 slides along the suture 18 back into the heart chamber 14 where it forms a Larks head around the edge of the valve leaflet as shown in FIG. 8F . [0023] Multiple sutures 18 may be implanted in this manner until a satisfactory result is obtained. After deployment of the sutures 18 , the heart wall incision is repaired by either a pre-positioned purse-string suture or by any kind of appropriate hemostatic device or technique. Hemostasis is checked, appropriate chest drainage tubes are positioned and secured, and all incisions are closed. [0024] As shown in FIGS. 9A-9D , a second embodiment of the suture deployment system at the distal end of the instrument 10 is positioned around a valve leaflet 16 to be repaired as shown in FIG. 9A . The suture 18 in this embodiment is a closed loop with one end of the loop disposed in the tip 160 and its other end disposed in the lumen 164 and wrapped around the needle 180 . The needle 180 is extended through the grasped valve leaflet 16 into the instrument tip 160 where it hooks one end of the looped suture 18 in a notch 166 formed on one side of the needle as shown in FIG. 9B . The needle 180 is then retracted to pull the the looped suture 18 through the puncture opening in the leaflet 16 . The leaflet is then released as shown in FIG. 9C by sliding the tip 160 to its open position. The instrument 10 is then withdrawn as shown in FIG. 9D to slide the unhooked end of the looped suture 18 along the length of the needle toward the leaflet 16 where it forms a Larks head around the leaflet edge. [0025] The instrument 10 is then withdrawing from the heart chamber 14 pulling the hooked end of the suture 18 through the heart wall. The suture 18 is secured to the outside of the heart apex. [0026] As shown in FIGS. 10A-10D , a third embodiment of the suture deployment system at the distal end of the instrument 10 is positioned around a valve leaflet 16 to be repaired as shown in FIG. 10A . The midpoint 17 of the suture 18 is looped around the lumen 164 and its two loose ends 20 are coiled up in the tip 160 . After the tip 160 is closed to capture the valve leaflet 16 , the needle 180 is extended through the grasped valve leaflet 16 into the instrument tip 160 . The free ends 20 of the suture 18 are positioned in the tip 160 to form a loop 19 and a notch 166 formed on one side of the needle extends through this loop 19 and “hooks” the free ends of the suture 18 as shown in FIG. 10B . The needle 180 is then retracted back into the lumen 164 to pull the hooked ends of the suture 18 through the puncture opening in the leaflet 16 . The leaflet is then released as shown in FIG. 10C by sliding the tip 160 to its open position. The instrument 10 is then withdrawn from the heart as shown in FIG. 10D to pull the free ends 20 back through the valve leaflet 16 and a Larks head is formed around the leaflet edge by the midpoint 17 of the suture 18 . [0027] The instrument 10 is then withdrawn from the heart chamber 14 pulling the free ends 20 of the suture 18 through the heart wall. The free ends 20 of the suture 18 are secured to the outside of the heart apex. [0028] Other suture deployment systems are possible where, for example, the needle may penetrate through the leaflet and link up with a snap fitting device that is attached to one end of the looped suture 18 in the instrument tip 160 . The needle then withdraws pulling the device and looped suture back through the penetration opening in the leaflet as described above. [0029] As shown in FIG. 7 to enhance visibility during this procedure, four fiberoptic channels 170 extend along the length of the instrument shaft 100 and terminate at its distal end. Each channel 170 contains at least one illuminating fiber which connects at its extrathoracic end to a white light source (not shown in the drawings). Each channel 170 also contains at least one sensor fiber which conveys reflected light from the distal end back to a visualization monitor (not shown in the drawings) connected to its extrathoracic end. In the preferred embodiment each channel 170 includes two illuminating fibers and two sensor fibers. [0030] The four fiberoptic channels 170 are disposed around the needle lumen 164 such that when a valve leaflet 16 is properly grasped, the valve leaflet tissue 16 rests against the distal end of all the fibers 170 . As a result, light is reflected off the tissue back into the sensor fibers and four white circles are displayed on the visualization monitor. When the leaflet 16 is not properly pressed against the distal end of a channel 170 , light is not reflected from the leaflet 16 and the visualization monitor displays the red color reflected from blood. When no valve tissue is captured, the monitor shows four red dots and when valve tissue is captured, the dots corresponding to the fiberoptic channels 170 contacting the tissue turn white. If the monitor shows all four dots as white, it means that the valve tissue capture is optimal. If only the upper two dots turn white and the bottom dots remain red, the “bite” on the valve leaflet 16 is too shallow for a proper attachment of the suture 18 . [0031] In addition to the fiberoptic visualization system that insures that a valve leaflet is properly captured, other real-time visualization systems are employed to help guide the instrument 10 to the valve leaflet 16 . Preferably a transesophageal or intravascular color-Doppler echocardiography system is used for this purpose. As explained above, this imaging system is also used to determine the length of the neo-implanted artificial chordae in real-time by observing reduction or disappearance of regurgitation by transesophageal or intravascular color-Doppler echocardiography.

1a

This application claims priority and is a continuation of PCT application serial number PCT/US2007/013781 filed 12 Jun. 2007, pending, which claims priority of U.S. provisional application Ser. No. 60/813,288 filed 13 Jun. 2006. GOVERNMENT INTEREST The invention described herein may be manufactured, used and licensed by or for the U.S. Government. BACKGROUND OF THE INVENTION 1. Field of the Invention The methods of the present invention provide a unique and superior formulation of artesunic acid for parenteral injection and for the manufacture of the formulation under sterile conditions. The methods described herein provide a demonstrably sterile, non-pyrogenic product which dissolves rapidly with no frothing or caking, yielding a clear, conveniently prepared solution the attending physician may administer with confidence. The formulation that is prepared by the methods of the invention is especially suitable for the treatment of severe and complicated malaria. 2. Brief Description of Related Art Although malaria affects about 250 million people and kills one to two million children each year, the pharmaceutical industry has shown little interest in developing new or manufacturing established antimalarial drugs not only because risks are significant, but the returns on investment are so low. Currently, the most promising and most rapidly acting antimalarial drugs are derivatives of artemisinin (qinghaosu) obtained from qinghao or sweet wormwood ( Artemesia annua ); these drugs have been developed and manufactured in China. Three compounds of the qinghao family have been used: the parent artemisinin and two of its more-active derivatives: a water-soluble hemisuccinate, artesunate (AS), and an oil-soluble ether, artemether (AM). Both derivatives are metabolized to a common biologically active metabolite, dihydroartemisinin (DHA). Although this facile conversion (hydrolysis) to DHA contributes to the AS rapid antimalarial activity, it also limits the choices of practical AS dosage formulations. Artesunic acid is also known to be effective in the treatment of severe (neuropathic) malaria, Artesunate versus quinine for treatment of severe falciparum malaria, a randomized trial , Dondorp, et al; Lancet, vol. 366, pages 717-725, Aug. 27, 2005, incorporated herein in its entirely by reference. However, Artesunic Acid is an intrinsically unstable compound, susceptible to decomposition by heat, radiation, and virtually any aqueous solution. Prior studies have confirmed the breakdown of artesunate in aqueous solutions. AS has been used for injection with good results. However, there are drawbacks of the current commercially available AS dosage form. It is a two-component product consisting of a dry-fill powder of sterile artesunic acid in a vial and a sterile 5% sodium bicarbonate solution in an ampoule. This product, “Artesunate For Injection”, is manufactured by Guilin Pharmaceutical Factory, Guangxi, China. This presently used formulation, when dissolved in the supplied bicarbonate buffer solution, results in fizzing and incomplete solution so that the concentration (dose) to be delivered may be uncertain. The formulation of artesunic acid mentioned above is manufactured in China, and prepared by an undivulged method which results in a product of poor dissolution characteristics, and which froths and cakes upon introduction of the dissolution medium (5% bicarbonate). As the AS dissolves, carbon dioxide is evolved and trapped in the small volume of the closed vial. The formed gas bubbles carry un-dissolved AS particles throughout the vial, thereby reducing contact between these particles and the dissolution medium and lengthening the time needed to completely dissolve the AS. Moreover, this phenomenon reduces the investigator's ability to see if the solution is complete so the next preparation step, which is to dilute the AS/bicarbonate solution with 5 mL of sterile 5% glucose solution, can begin. These delays can unduly lengthen the overall solution preparation time, resulting in a shorter time period over which the prepared solution can be administered. Further and most importantly, the product coming from China is not manufactured under the U.S. Food and Drug Administration's current Good Manufacturing Practice (cGMP). Therefore, it is an object of the present invention to provide an AS product and a method for preparing an AS product that dissolves quickly, thoroughly and does not cake or fizz upon dissolution. It is another object of the present invention to prepare an AS product that does not require an additional step of diluting with glucose and is immediately usable upon dissolution. Another object of the present invention is to develop a method for the production of an artesunic acid solution for the intravenous or intramuscular treatment of malaria that is sterile and manufactured under current Good Manufacturing Practice (cGMP) as required by the U.S. Food and Drug Administration. Another object of the present invention is to sterilize artesunic acid powder without decomposition. Another object of the invention is to prepare an artesunic acid product that has a shelf life of two years. These and other objects will become apparent upon further reading of this application. SUMMARY OF THE INVENTION The invention is a method for the manufacture of an intravenous or intramuscular formulation of artesunic acid. First the artesunic acid powder is sterilized with ethylene oxide and placed into a sterile container. Nitrogen is used to purge water vapor from the container, after which the container is hermetically sealed. When used, the sterilized powder is dissolved in sterile sodium phosphate buffered solution to produce a solution suitable for intravenous or intramuscular administration. The sodium phosphate buffered solution dissolves the artesunic acid powder without caking or frothing, resulting in an improved drug product. The invention also relates to the formulation and a method of treating a patient with severe and complicated malaria. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is drug manufacturing flow diagram; FIG. 2 is the chemical structure of α-Artesunic Acid. DETAILED DESCRIPTION The AS parenteral dosage form must be sterile and not produce CO 2 when the AS dissolves. To avoid CO 2 evolution, we used a non-carbonate-containing, physiologically compatible basic medium. We also manufactured our drug product under cGMP. Dissolution Medium The dissolution medium is sodium phosphate buffered solution. In addition to avoiding the production of gas, the dissolution medium must rapidly dissolve the AS, produce a solution in which the dissolved AS is sufficiently stable, and yields a solution of physiologically acceptable pH and osmolality. After many trials and errors, we found that a 0.30±0.05 M, pH 8.0±0.3 sodium phosphate solution meets all of the above requirements and is preferred. Slight variations from these values are acceptable. The solute in the dissolution medium has been identified as sodium phosphate by spectral and chromatographic evidence. The average phosphate concentration is 0.30 plus or minus 0.05 M. The average solution volume is 11.0 plus or minus 0.5 mL. The average solution pH is 8.0 plus or minus 0.3. Preparation of the 0.30M, pH 8.0 sodium phosphate solution, following a USP procedure, was straightforward and under cGMP. Sterile phosphate solution, 0.30 M, pH 8.0, is manufactured by mixing appropriate weights of monobasic and dibasic sodium phosphate in distilled water to a molarity of 0.30 M and pH of 8.0. The phosphate solution is then sterilized by filtration through a 0.22μ filter into 20 mL vials (12.2 mL/vial). The vials are sealed and then stored at room temperature. Sterility of the product, achieved through sterile filtration of the phosphate solution and autoclave of the filled, sealed vials, was accomplished smoothly by Afton Scientific Corporation, Charlottesville, Va. 22902. After having met USP requirements for identity of the product, product sterility, endotoxin, solution concentration, volume, pH, osmolality, and particulates, 10,900 vials of this medium were labeled Afton Batch 57804, assigned WR135946; BR18064, and designated as Component Two of our AS dosage form. The USP procedure is found in 2005 USP 28/NF 23, p2855; Composition of Standard Buffer Solutions, incorporated herein by reference. Active Component The active component is Artesunic Acid (AS), 110 mg/vial, SRI Batch No. 14462-16, from SRI International, Menlo Park, Calif. The Chemical Abstracts (CA) Index name for artesunic acid is: butanedioic Acid, [3R-(3α,5a,6,8a,9α,10α,12,12aR*)]-mono(decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin-10-yl) ester. The CA Registry Number is 88495-63-0, and the molecular formula is C 19 H 28 O 8 . The formula weight of α-artesunic acid is 384.43 g/mol. This name also defines the stereochemistry at C-10 which, according to the CIP convention, is based on the priority of groups attached to C-10. The 10α- designation refers to the O-succinal group oriented back or toward the peroxide bridge. The 10- designation refers to the O-succinal group oriented away from the peroxide bridge. The molecular formula, C 19 H 28 O 8 , corresponds to a molecular composition of C, 59.36%; H, 7.34%; and 0, 33.29%; and a molecular weight of 384.43. α-Artesunic Acid is shown in FIG. 2 . The formulation development of the active component AS requires sterilization of the bulk drug. For a sterilization process to be acceptable, not only sterility of the bulk chemical must be shown, but the process must not alter the physical or chemical nature or the stability of the material. The high purity AS bulk drug, a finely milled, white crystalline powder manufactured by Knoll AG, Listal, Switzerland was used. An acceptable EtO treatment cycle was developed and employed as follows: Sterilization of Bulk Artesunic Acid The bulk AS was sterilized before dry fill. Gas sterilization was used. Below are the salient points of the method and the determinations for sterility and pyrogenicity. Artesunic Acid is treated for one hour at 102 degrees Fahrenheit and 100% humidity. The chamber is evacuated and ethylene oxide is introduced and maintained at constant pressure and 102 degrees Fahrenheit for four hours. The sterilant cycle is stopped; the chamber is evacuated and washed twice with nitrogen and once with air, all at 102 degrees Fahrenheit. Slight variations of this sterilization method are possible. A sample of treated AS is chromatographed. Chromatograms for both treated and untreated AS are identical. AS is stable under the conditions of treatment. Samples are tested for residual ethylene oxide, ethylene chlorohydrin and ethylene glycol. Neither ethylene chlorohydrin nor ethylene glycol was detected. Ethylene oxide was detected but at levels well below the FDA proposed limit. A microbial limits test was performed and validated to determine the inhibitory properties of AS. The test was negative. AS has no inhibitory properties in this test. (USP 27<61> & <71>). Sterility tests were performed to discover the possible presence of bacteria, fungi, and spores. Samples were doped before treatment with a spore strip, bacteria, and fungi. No colony forming units were found in any test. The treated material is sterile. (USP 27<71>). The Limulus Amebocyte Lysate test was performed to determine the endotoxin levels in the treated AS. Endotoxin levels were below the detectable level in the treated AS. (USP 27<85>) Ethylene oxide is an effective sterilant for bulk artesunic acid. Results from alidated sterility tests on sterilized artesunic acid meet USP requirements for sterility testing. Sterilized artesunic acid also meets USP requirements for endotoxins. The EtO-treated AS was dry filled into sterile vials. The best mode for this purpose was to use a portable, manually operated powder dispensing machine was purchased from M&O Perry Industries, Corona, Calif. 92880. Owing to the propensity of the AS bulk drug to clump and cling to the metal surface of the machine, characteristics that prevent both complete filling and complete discharge of the machine loads, the machine was fitted with a plastic liner that reduced the clinging and enabled quantitative discharges. The installation qualification (IQ)/operation qualification (OQ)/and performance qualification (PQ) were performed to qualify the filling machine for cGMP manufacturing. The Model LM-14 is a compact, portable bench top unit complete with carrying handle. It is an ideal machine for small fill weight, low volume applications. Other filling machines exist which are suitable for large operations. Pre-cleaned and sterilized 20-mL vials, sterilized gray butyl rubber stoppers and flip-off aluminum seals were purchased. In a class 100 room, under laminar flow, the vials were filled in a glove box with EtO-treated AS. Scheduled weight checks were performed to ensure the filled weights met specifications. The filled vials were stoppered, sealed, and tested for release. After meeting requirements for sterility, identity, purity, content uniformity, and after constitution in sodium phosphate buffer, for solution pH, osmolality, and particulate counts, 5,500 of the filled vials were labeled SRI Batch 14462-16, assigned WR256283:BR29487, and designated as Component One of our AS dosage form. Analytical Methods of Specifications for Sterile Intravenous Artesunate (110 mg/Vial) Tests Analytical Methods Specifications Appearance Visual Fine crystalline powder Color Visual White to almost white Identity IR Conforms to Reference Must comply Spectrum HPLC HPLC SRI TM 1900.200 Must comply Assay (HPLC) HPLC 98.0 to 102.0% calculated on water-free basis pH SOP SRI 004.009 7.2-7.7 Particulate USP 788>, small volume No More Than (NMT) 6000 Matter in injections particles of size 10 μm/vial. Injections NMT 600 particles of size 25 μ/vial. Uniformity USP 905>, Solids in None outside 88-132 mg/vial, of Dosage Single Unit Containers RSD of 10 vials ≦6.0% in Units Level 1; if fail, go to Level 2. Sterility USP 71> Sterile Bacterial USP 27 through Sup 85> 35 EU/mL Endotoxins, LAL, Kinetic Placebo The selection of a material for the AS placebo was based on a likeness in appearance and physical characteristics to that of the AS dosage form, in addition to being biologically inert. The placebo for the AS Dosage Form was Mannitol, 200 mg/vial. A large number of possible placebos were investigated. The two final candidates were mannitol and glucose, with the former having a slight edge. Because the particle size of the commercially available USP mannitol was larger than that of the AS bulk drug, the mannitol was milled and sieved to match the size and appearance of the AS powder prior to sterilization. Sterilization by irradiation initially looked promising, but after two weeks on the shelf the irradiated mannitol became discolored. Ultimately, treatment with EtO proved successful, and the sterilized mannitol was dry-filled into the same type of glass vials as the active material and processed identically. Because the density of our mannitol was nearly twice that of the AS bulk drug, the filled placebo mass was nearly twice that of the active, to maintain comparable filled volumes. After having met requirements on content uniformity, identity, and purity, and after constitution with phosphate, for solution pH, osmolality, and particulate counts, 2,500 vials of the placebo were labeled SRI Batch 14462-28 and designated WR016506:BR29487. To maintain anonymity, a common label, identifying both the AS and Placebo, was used for vials of the active as well as vials of its placebo. In Phase I clinical trials the placebo was ethylene oxide treated mannitol, exhibiting the same appearance and dissolution characteristics as the Active Pharmaceutical Ingredient (API). The placebo was manufactured by SRI International. All clinical materials are stored, maintained, and shipped by the repository contractor (monitored and managed by The Department of Chemical Information). The repository contractor also prepares the double-blinded samples of artesunic acid or placebo for clinical use under guidance from the Department of Chemical Information. The placebo has provided an acceptable control for the recently completed phase I clinical trials. Analytical Methods and Specifications for Sterile Placebo for Injection (200 mg/Vial) Tests Analytical Methods Specifications Appearance Visual Fine crystalline powder Color Visual White to almost white Absence of Artesunic Acid I.R. None detected Mannitol Content USP (Identity) Passes Ethylene Oxide Residual USP 71> 200 ppm Ethylene Chlorohydrin Residual NV SOP 12C-25 (ECH) 120 ppm Sterility USP 71> Microbial growth is not observed Uniformity of Dosage Units USP <905>, solids in None outside 88-132 mg/vial, Single Unit Containers RSD of 10 vials ≦6.0% in Level 1; if fail, go to Level Particulate Matter in Injections USP <788> No More Than (NMT) 6000 particles of size 10 μm/vial. NMT 600 particles of size 25 μ/vial. Dosage A typical dosage of α-artesunic acid for parenteral administration is 10 mg/mL for a 10 mL injection. 110 mg is the unit dose for manufacture. Typically, using a sterile syringe, 11 mL of sterile Phosphate buffer for injection will be added to the 110 mg artesunate vial and the vial swirled for about 4-6 minutes for full dissolution. Dosing is 1-4 mg/Kg body weight for intravenous administration with the possibility of up to 8 mg/Kg in some cases. Preferred dosing is 2-3 mg/Kg body weight for intravenous administration for three days. A drip bag is also suitable for administration of the dose. A dosage of 50 mg/mL is suitable for IM injection. IM treatment will be in the range of 1-5 mg/Kg body weight. Give dosage one to two times per day for 3 days for IM. Because the present inventors use a phosphate buffer solution, they are able to obtain a higher concentration of AS for injection than that which can be obtained with the 5% glucose dilution medium required by the Guilin formulation. Discussion The cGMP-manufactured α-artesunic acid parenteral dosage form of the invention offers several advantages over current, commercially available version(s) of Artesunate drug. 1. The cGMP-manufactured sterile dissolution medium, a 0.30 M, pH 8.0 solution of sodium phosphate, completely dissolves the α-artesunic acid in 2-3 min, requiring only gentle swirling. This rate of dissolution is several fold faster than that found for the Guilin product, following its directions for preparation given in its package insert. 2. Because the dissolution of AS in phosphate is not accompanied by gaseous evolution, as in the case where bicarbonate is used, determining solution completeness is readily achieved. 3. The solution prepared in phosphate is ready for administration, as no further preparation is required. The Guilin product, on the other hand, requires an additional step of dilution of the AS/bicarbonate solution with 5 mL of 5% glucose, which also must be sterile. 4. The pH of our 10 mg AS/mL solution in phosphate is 7.2, whereas that for 10 mg AS/mL solution in bicarbonate/glucose is 7.9, a solution pH that is higher than ideal for parenteral administration. 5. The osmolality of our 10 mg AS/mL solution in phosphate is 320 and that for the 10 mg AS/mL solution in bicarbonate/glucose is 410, a value also higher than ideal for parenteral administration. 6. The phosphate buffer solution of the GMP manufactured formulation allows AS concentrations high enough for effective IM treatment. Although hydrolysis of AS in phosphate or bicarbonate/glucose begins almost immediately upon dissolution, the rates of decomposition in the two media are comparable. After two hrs at ˜24° C. the solutions were still visibly clear and therefore still can be administered. In keeping with US FDA requirements, vials of the phosphate vehicle, the AS, and the placebo are undergoing accelerated and shelf-life stability studies. Efficacy in Trials: An Investigational New Drug Application (IND-64769) on this drug product has been filed with the FDA and has been approved for use in clinical trials. Phase Ia Safety and Tolerance single dose clinical trials hare been concluded and were successful. Phase Ia Safety and Tolerance of GMP Formulation Phase Ia is a single dose double-blind placebo-controlled, randomized study to evaluate the safety and tolerance of the GMP formulation of intravenous artesunate. The study has been completed successfully as is necessary to proceed to Phase IB and Phase II trials. Phase Ib and Phase II trials are in progress. Phase Ib Safety, Tolerance and Pharmacokinetics/Pharmacodynamics of GMP Formulation A Phase 1 b is a double-blind, placebo-controlled, randomized multiple dose escalation study to evaluate the safety, tolerance, and pharmacokinetics/pharmacodynamics of GMP formulation of intravenous artesunate in healthy human subjects in 3 doses using a dose escalation format using a placebo control. An objective is to determine the safety of multiple dose administration of escalating doses of artesunate that bracket the anticipated compassionate use dose of 2.4 mg/kg by measuring adverse events (AE) and cardiovascular responses (heart rate (HR), blood pressure (BP), and electrocardiogram (ECG)). Another objective is to determine the safety and tolerability of the compassionate use of 3 doses of artesunate in escalating doses of 0.5, 1.0, 2.0, 4.0, and 8.0 mg/kg with placebo control. The primary and secondary outcomes are to assess AE and hemodynamic and cardiac responses (BP,HR, ECG) and to determine pharmacokinetic parameters of artesunate and its major metabolite DHA as well as to assess preliminary dose-toxic response. The study design is as follows: Phase I, randomized, double-blind, placebo-controlled trial using multiple ascending doses of intravenous artesunate to determine its safety, tolerability and pharmacokinetics in healthy male and female subjects. Subjects will be screened within 21 days of dosing. At the screening visit, subjects will undergo baseline VS, PE, CBC with smear, differential and indices, reticulocyte count measured by flow cytometry, haptoglobin, COAGs, Chem, UA, urine drug screen, urine HCG and medical and medication history. Eligible subjects will be scheduled for a 6-hour outpatient visit for pre-dose ECGs and VS done to approximately match dosing schedule on Day 1. On Day 0, subjects will be admitted to the CPU to begin the inpatient phase of the study. Subjects will have a brief physical and review all procedures for the inpatient stay. On Day 1, pre-dose, VS and ECG will be performed. Subjects then will receive IV study drug or placebo. Subjects will be closely monitored by evaluating hemodynamic measurements, periodic ECGs, and assessment of spontaneously reported AEs. Blood will be drawn for blood count and chemistry analysis within 12 hours of the first and last doses. PK will be drawn at designated times after each dose administered. On Days 2 and 3 subjects will receive their second and third doses, respectively, of study drug or placebo followed by close clinical monitoring and laboratory measurements as described for the first doses given. Subjects will be discharged 24 hours after the third dose of drug or placebo and followed as outpatients on Days 7, 10, and 15. The study population will consist of 40 healthy male and non-pregnant female adults given artesunate GMP manufactured for injection intravenously. The duration of the study will be a screening of up to 21 days; 5 days (four nights) inpatient and 3 outpatient visits (last visit day 15) per patient. Phase II Trials: In Phase II trials, the artesunic acid parenteral dosage form of the invention vas given intravenously to human subjects in Africa to treat malaria. In trials in Africa, COL Peter Weina, Chief, Department of Pharmacology, Walter Reed Army Institute of Research has reported 30 adult male and female volunteer patients with uncomplicated malaria have been successfully treated using the treatment regimen as outlined in this application. Successfully treated is defined as safely clearing P. falciparum malaria parasites from the blood. Patients were given a single dose of 1-4 milligrams per kilogram body weight in the form of an injection through an IV catheter (a tube with a needle attached) once a day for 3 days in a row. There were no adverse effects from the GMP IV treatment of the artesunate of the invention. The single adverse effect was with the standard-of-care positive control drug Malarone. Stability Studies Six thousand dry-filled vials of formulated artesunate for clinical use have been packaged. One thousand of the vials have been reserved for long-term stability testing under various conditions, including elevated temperatures and humidities, to test the integrity and durability of the packaging system. As packaged for clinical use, 20 ml vials have been dry-filled with 110 mg of ethylene oxide sterilized artesunate, stoppered, and sealed. Stability studies at Knoll have shown at least two years stability for bulk artesunic acid stored under nitrogen @ 25° C. The sterilized bulk drug of the invention has been tested and is still undergoing stability studies. The sterilized bulk drug has shown no evidence of degradation for 20 months at 25° C. The stability studies are still ongoing. Having generally described this invention, a further under-standing can be obtained by reference to certain specific examples which are provided herein for purposes of illustration only and are not intended to be limiting unless otherwise specified. EXAMPLES Example 1 GMP Formulation and Packaging Upon receipt of the accessible portions of the European Drug Master File (DMF) for artesunic acid from Knoll, the inventors compared their analytical protocols for artesunic acid to those used in the DMF. The DMF method used by Knoll is as follows: Validation of an HPLC-Based Assay for AS HPLC was performed using the following conditions: LC system Solvent Delivery Waters 600 Pump System Controller Injector Waters 717+ Auto Sampler Detector Waters 996 Photo Diode Array (PDA) Quantitation Empower, Build Number 1154 Software Method Conditions Column YMC ODS-AQ 2 250 mm Length × 4.6-mm ID, 3 μm Mobile Phase 35:65 A:B where A = 0.01M potassium dihydrogen phosphate, pH 3.8, and B = Acetonitrile Flow Rate 1.20 mL/min; pressure~2400 psig Injection Size 30-μL Run Time 20 min Detection UV @ 205 nm The reference solutions (n = 5 each) were prepared by accurately weighing between 3.472 to 15.977 mg of the reference and dissolving each in 1.00 mL of acetonitrile. A series of 30-μL injections were made to deliver 104.2 to 479.3 μg of reference on column for assay. Calculations (Apply to Both Reference and Sample) The mass of sample on column (m x , μg) was calculated using equation one (EQ. 1) m x =W x ×( V 1 /V x )  Eq. 1 where, W x is the sampled mass (mg) of the reference or sample (S) as weighed, V x is the volume of solvent (1.00 mL acetonitrile) used, and V 1 is volume of solution injected (30 μL). An area to mass on column response factor (RF A ) vas Calculated for the reference standard using equation two (Eq. 2) RF A =( A R /m R )×(100%/ P R )  Eq. 2 Where, A R is the reference peak area, and P R is the reference purity (>99%) 3 . Sample peak area data was used in equation three (Eq. 3) to calculate the mass (m s ) of the sample, m s =A S ×(100%/ RF A )  Eq. 3 where A s is the sample peak area. Duplicating all the experimental conditions used by Knoll, the inventors confirmed the results of its previously validated HPLC assay. Upon validation of the imported Knoll assay, it was adopted as one of the assays to be used by the inventors to confirm the identity of artesunic acid samples and to test the purity of such samples. The major advantage of the Knoll method was lowering the LOD from 2 ug to 0.075 ug on column and decreasing the assay time from 16 minutes to 8 minutes. The major disadvantage is its inability to determine AS in phosphate. Precision, linearity, quantation, and accuracy were comparable for both methods. The inventors verified the identity and determined the purity of three samplings of WR256283; BQ38641, (Knoll Lot 2.03). This was the milled sample of the bulk Knoll drug substance used in formulation of the injectable artesunic acid for clinical trials. The three samples were taken to confirm the identity and uniformity of the received material (Sample A from the top of the container, Sample B from the middle of the same container, and Sample C from the bottom of the container). They were compared to a reference sample received Jun. 29, 2001 (WR256283; BP18288) using a number of analytical tests including, but not limited to, Fourier Transform Infrared Spectroscopy, Proton Nuclear Magnetic Resonance Spectroscopy, Elemental Analysis, High Performance Liquid Chromatography, Thermogravimetric Analysis, Residual Solvents by Gas Chromatography, and Inductively Coupled Plasma. The samples were confirmed as being identical samples of artesunic acid. Purity was determined with an HPLC-based assay using the external standard method, with a known reference purity of >99%. HPLC results confirmed sample purity was 99.3 plus or minus 0.3%. Residual solvents in the Knoll material include heptanes (0.09%) and ethyl acetate (0.04%), plus trace amounts (<0.01%) of methanol and ethanol. Lead was not found. SRI verified that an ethylene oxide sterilization treatment (4 hours at 102 degrees F.) does not degrade artesunate; the treated material meets USP requirements for sterility. The EtO treated sample was purged with nitrogen to remove residual ethylene oxide. Subsequently, bioburden, bacteriostasis, fungistasis, and endotoxin tests were performed to validate the sterility treatment method. Tests for ethylene oxide derivatives were negative and the residual EtO was found to be well below the FDA recommended levels. Tests for artesunate breakdown products, including dihydroartemisinin, were similarly negative. Results from validated bioburden and LAL tests on sterilized artesunate met USP requirements for sterility and endotoxins. The average chromatographic purity after ethylene oxide treatment was found to be 99.9 plus or minus 0.4% relative to the reference standard. Qualitative and quantitative assay results verified the chemical integrity of the ethylene oxide-treated artesunate. These results establish the time zero data point for future ethylene oxide-treated artesunate stability studies. Six thousand dry-filled vials of formulated artesunic acid for clinical use have been packaged. One thousand of the vials have been reserved for long-term stability testing under various conditions, including elevated temperatures and humidities, to test the integrity and durability of the packaging systems. As packaged for clinical use, 20 ml vials have been dry-filled with 110 mg of ethylene oxide sterilized artesunic acid, stoppered, and sealed. Stability studies at Knoll have shown at least two years stability for bulk artesunic acid stored under nitrogen @ 25° C. Example 2 Preclinical Toxicology Tests of the dry-filled artesunate formulation were used in the GLP 14-day dog toxicity study. A concentrated formulation of 50 mg AS/ml was developed and manufactured for a 14-day cGLP toxicity study in dogs. The dry-filled artesunic acid formulation used in the GLP 14-day dog toxicity study was confirmed to be of high purity by independent analysis. The artesunic acid content weights, calculated from determining the mg of artesunic acid/mL in reconstituted samples, met the requirements set forth in USP Article <905> and ranged between 501 to 519 mg/vial. The potential toxicity of GMP artesunate of the invention was tested in beagle dogs. The artesunate was administered daily by rapid intravenous infusion (over 4 to 6 minutes) for 14 days. Four groups consisting of 4 dogs/sex/group were treated daily with doses of artesunate at 10, 20, 35, or 50 mg/kg/day at dose volumes of 1 mL/kg. One group of 4 dogs/sex received sterile 0.3 M phosphate buffer (control article) and served as the control group. The study was divided into two parts. After 14 doses, 2 dogs/sex/group were necropsied on study day (SD) 15. The remaining two dogs/sex/group were allowed a 2-week treatment-free recovery period and were necropsied on study day 29. Measurements included survival, clinical observations, body weights, electrocardiography, hematology, clinical chemistry, coagulation parameters, gross pathology, organ weights, and histopathology (Wu and Senate, 2004). Intravenous doses of artesunate up to and including 50 mg/kg/day did not result in test article-related effects on mortality, clinical observations, body weights, body weight gains, food consumption, electrocardiographic output, clinical chemistry and coagulation, gross pathology, organ weights, and histopathology. During the course of the study, erythema, diarrhea, emesis, mucoid feces, and soft feces were observed sporadically in both control and test article-treated groups, and were not considered to be test article-related. Intravenous administration of artesunate at doses of 20, 35, or 50 mg/kg/day for 14 days in beagle dogs resulted in lowered red blood cell parameters (RBC, HGB, HCT, and RETIC) measured on study day 15. The lower reticulocyte counts suggested that there was not a regenerative response to the lower RBCs. The lowered red blood cell parameters found on study day 15 were not present on study day 29. Based on the results of this study, artesunate, when administered intravenously for 14 days at doses up to and including 50 mg/kg/day, did not result in any other test article-related adverse effects except on the measure hematology. At doses of 20 mg/kg/day and above, intravenous administration of artesunate for 14 days resulted in a transient test article-related effect on red blood cell parameters, including RBC, HGB, HCT, and RETIC. Having now fully described the invention, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth herein.

1a

BACKGROUND OF THE INVENTION [0001] It has been hypothesized that the use of olive oil as a significant source of dietary fat affords cardioprotection. The hypothesis derives, at least in part, from the association of the wide use of olive oil throughout the Mediterranean area with a low incidence of coronary heart disease and certain cancers, e.g., breast and colon, among populations in that area. Visioli, F. & Galli, C., Cardiovascular Reviews and Reports, pp. 389-392, 389 (July 2002). [0002] The cardioprotective effect associated with the use of olive oil has been attributed to its high content of oleic acid, a monounsaturated fatty acid that constitutes 56%-84% of the total fatty acids in olive oil. Id. More recent evidence shows that the phenolic components of extra-virgin olive oil may play a role in the protection from coronary heart disease observed in the populations of the Mediterranean area. Among the phenolic components of olive oil are those categorized as complex, e.g., oleuropein (OE), and simple, e.g., the oleuropen derivative hydroxytyrosol (HT). Id. [0003] The phenolic components are present in substantial quantities only in extra-virgin olive oil. The variety designated merely “olive oil” is virtually devoid of such phenolic compounds. Id. It is believed that the presence of the phenolics in the extra virgin oil, but not in merely olive oil, is attributable to the methods used in the extraction of the oil from the olives. These phenolic components of the extra virgin olive oil have been shown to possess potent and dose-dependent anti-oxidant activities and play an important role in enzyme modulation. Visioli & Galli, p. 390. [0004] Another derivative of oleuropein, the aglycon, which is obtainable by oleuropein hydrolysis, is well known as a pharmacologically active molecule for its potential application as an antimicrobial agent in common olive tree diseases. Brante, R. et al., J. Agric. Food Chem., 49, 3198-3203 (2001). [0005] The phenolic components also correlate with the pungent and bitter taste of the oil, reduction of the oxidative process of fruity flavored aromatic compounds, and the improvement of the olive oil shelf life. Rodis et al., J. Agric. Food Chem, 50, 596-601 (2002). [0006] The phenolic compounds are either originally present in the olive fruit, or are formed during olive oil extraction. The phenolic compounds, once released or formed during processing of the olives, are distributed between the water and oil phases. Other phenolic constituents are trapped in the solid phase, also known as the “pomace.” Rodis et al., p. 596. The distribution of the phenolics between the water and oil is dependent on their solubilities in the two phases. Only a very minor amount of the phenolics enter the oil phase. In general, the concentration of phenolics in the olive oil ranges from 50 to 1,000 μg/g of oil depending on the olive variety. Id. This amount of antioxidant in the olive oil is 1%-2% of the available pool of antioxidants in the olive fruit. The rest is lost with the waste water (approximately 53%) and the pomace (approximately 45%) depending on the extraction system. Id. Consequently, the low partition efficients of most olive oil antioxidants result in a substantial loss of those components with the waste water during processing. Rodis et al. p. 600; see also Visioli, et al., J. Agric. Food Chem, 47, 3397-3401, (1991). [0007] The substantial loss of such phenolics is attributable, at least in part, to the fact that a considerable amount of water is employed during the malaxation of extraction process. Malaxation is the continuous washing of the olive paste with warm water prior to the separation of the oil from the paste. The wash water, in addition to that endogenously contained in the olives, is separated from the olive oil and is referred to generally as “waste water” or Olive Vegetation Water (OVW). OVW is a complex emulsion that includes many potentially valuable components, e.g., oil, sugars, polyphenolics, and oleuropein and its various derivatives. [0008] The OVW presents both opportunity and added costs to the olive oil production process. For example, OVW is a toxic and polluting residue for plants. Certain phenolic compounds within the OVW (e.g., hydroxytyrosol and other polyphenols) show phytotoxic activities for some crops. Soler-Rivas, C., et al., J. Sci. Food Agric, 80, 1013-1023 (2000). Many constituents of the OVW are resistant to biodegradation and are not readily decomposed. And many of those constituents contribute to the emulsion. Thus far, the industry has been unable to develop suitable end-of-pipe treatment technology, and the processing and disposal of OVW constitutes a significant burden on a mill's economy. Visioli et al., p. 3397 (1999). [0009] Some of those phenolic compounds, however, are associated with potent antioxidant properties. Id. Thus, OVW has potential value as a source of phenolic antioxidants, and might also provide natural bactericidal agents for the protection of crops from pests and diseases. Id. [0010] Among the most important constituents of OVW is oleuropein and its various derivatives; and, of those, perhaps the most significant is oleuropein aglycon (OA). Soler-Rivas et al., p. 1017-1018 (2000). OA shows potent antioxidant activity, and has a synergistic effect with other constituents of olive oil, e.g., tocopherols. Oleuropein and its various degradation products have also been shown to demonstrate in vitro bactericidal and bacteriostatic activities. Soler-Rivas et al., p. 1019 (2000). OA is the product of a hydrolysis reaction effected by naturally occurring enzymes; and the rate of the reaction, and the resulting quantity of OA, is affected by the processing conditions employed. [0011] OA is increasingly the focus of commercial attention. Products containing oleuropein and its derivatives are on the market today. Many of those products originate from other sources, e.g., olive leaf, grape seed, and green tea. Further, such products contain mixtures of oleuropeins, and often result from inefficient and costly recovery processes. There remains a need for cost-effective processes for selectively collecting and purifying OA, and other potentially valuable constituents of OVW, and for preparing OVW for disposal. BRIEF DESCRIPITON OF THE DRAWINGS [0012] FIG. 1 illustrates the deglycosylation of oleuropein glycoside to oleuropein aglycoside, which takes place through the action of naturally occuring enzymes. [0013] FIGS. 2A and 2B are schematic illustrations of phase I and phase II of the oleuropein extraction and deglycosylation, as described more fully below. DETAILED DESCRIPTION OF THE INVENTION [0014] The instant invention provides methods for selectively removing and recovering oleuropein aglycon from OVW. In one embodiment, the method involves the following steps: Obtaining raw OVW comprising oleuropein, oleuropein aglycon, and conversion enzymes; Adding pomace oil to the raw OVW to concentrate oleuropein aglycon in a collection of floating solids; Adding citric acid and heat to form precipitated solids; Adding treated water to raw OVW to form additional precipitated solids and to increase oleuropein aglycon concentration; Adding a solvent mixture (e.g., hexane and acetone) to extract the oleuropeins and further concentrate oleuropein aglycon; and Adding treated water during a final evaporation stage to facilitate oil separation, solvent removal, and further increase the total level of oleuropeins extracted. The resulting OVW can be used for direct irrigation, or further treatment by conventional waste water processes. [0021] For purposes of the present invention, the term “raw OVW” refers to an aqueous mixture containing a mixture of oleuropein, oleuropein aglycon, and any of the naturally occurring enzymes capable of hydrolyzing oleuropein to oleuropein aglycon (i.e., conversion enzymes). In preferred embodiments, the raw OVW will be the product derived from a water wash of olive vegetation matter as in the manufacture of olive oil. In such embodiments, raw OVW will comprise the water from a washing step as well as endogenous water removed from the olive vegetation matter. [0022] The term “treated water” refers to raw OVW that has been processed to remove at least a portion of oleuropeins and oleuropein aglycon. Preferably, treated water will retain a substantial quantity of conversion enzymes. [0023] The term “floating solids” refers to an oleuropein aglycon-rich collection of water-immiscible constituents that are less dense than water and tend to form or migrate to the surface of the OVW. The floating solids are often manifested as a foam on the surface of the OVW. [0024] The term “precipitated solids” refers to water-immiscible constituents that are at least as dense as water. The precipitated solids will commonly comprise oleuropein and various sugars. In at least one embodiment of the present invention, those constituents are removed by filtration or centrifugation. [0000] Phase I [0025] The initial step to recover the polyphenolics, oleuropein aglycon and it's related compounds is to break the complex emulsion of the water. The initial step is to hold the olive vegetation water for 48 hours upon immediate production as a by-product of the olive oil or to by pass this holding phase and heat the water to 40° C. for 30 minutes in a vertical cylindrical steel vessel, preferably by steam. [0026] During this heating step the oleuropein is hydrolyzed to the aglycon (OA) by natural enzymes present in the olive vegetation water. The OA rises to the surface as a constituent of a water immiscible foam that can be continually removed by surface skimming or other conventional methods. [0027] The quantity of oleuropein aglycon can be increased in the floating foam by adding citric acid, olive pomace oil, and heat. Preferably, about 0.01% to about 1.0% citric acid is added; and more preferably, about 0.1% citric acid. Unless stated otherwise, all percentages are by weight. The olive pomace oil is preferably added in a quantity of about 2% about 20% of the raw OVW; and more preferably to a volume equal to about 10% of the volume of raw OVW. [0028] Heat can also be exploited to increase the quantity of OA in the foam. In preferred embodiments, the temperature is increased to about 100° C. for about one hour. Lower temperatures can be used for correspondingly longer periods to achieve substantially the same effect. During this heating step, additional solids precipitate and are suspended in the aqueous layer. The precipitated, or suspended, solids are high in oleuropeins, sugars, and other components. Although not wishing to be bound by any theory, we believe that the higher level of oleuropeins gained from the addition of the olive pomace oil is due to the drying of the foam as it passes through the hot oil and because the oleuropein aglycon is more oil soluble than the other forms. [0029] The floating solids on the top layer of the foam are removed by filtration or skimming, and the precipitated solids in the aqueous bottom layer can be removed by filtration or centrifugation. In a preferred embodiment approximately half of the resulting water is added to a second batch of raw olive vegetation water, and the extraction/treatment described above is repeated. [0030] The final water from this second process is cleaner and more environmentally benign, and can be discharged as irrigation water or it can be disposed of by conventional water treatment methods. [0031] During this second treatment process, a higher percentage of solids can be recovered thereby increasing the yield since a greater percentage of conversion enzymes accumulate. This process of keeping half of the volume of treated water and adding the other half of the volume from fresh olive vegetation water can be repeated as necessary or until all of the water produced is treated. The recovered solids can be dried, e.g., by heat or vacuum. [0000] Phase II [0032] In the second phase, the floating solids from the first phase are extracted by a mixture of solvents. Preferably, the collected floating solids are first dried before the extraction step is performed. Drying can take palce by air drying, under vacuum, with heat, or combinations thereof. Suitable solvents are non-polar organic solvents or mixtures of solvents. Non-polar organic solvents refers to organic solvents that are substantially immiscible with water, or those that are miscible with other organic solvents that are substantially immiscible with water. Exemplary solvents are alkanes (whether straight chain, branched, or cyclic), ethers, petroleum ethers, aromatic solvents and substituted aromatic solvents (e.g., benzene, toluene, xylene), polyols, and the like. Preferred solvents include pentane, hexane, heptane, acetone, ethyl acetate, diethyl ether, dimethyl furan, and mixtures thereof. It is further preferred that the solvent or solvent mixture has a boiling point lower than that of water (i.e., <100° C.). Especially preferred solvents include a mixture of hexane and acetone. Preferably, the hexane/acetone mixture is from about 40/60 (% by volume) to about 60/40; and more preferably about 50/50. [0033] In preferred embodiments, there are two additional steps in the extraction process. First, the non-polar solvent or solvent mixture is contacted with the recovered solids. The vertical cylindrical steel vessel, used as the heating equipment in the first step, can be used in this step. In a preferred embodiment, the solvent is pumped into a tank, pumped out of the bottom, and then re-circulated through the top until the desired concentration of oleuropein to oleuropein aglycon is obtained. Preferably, the volume of solvent used is about one to three liters of solvent per kilogram solids, and more preferably, about two to one (l/kg). [0034] In a second step, the solvent is removed. Solvent removal can be performed under vacuum, heat, or a combination thereof. Preferably, solvent removal is performed by transferring the oleuropein aglycon product of the above extraction step to a second vessel. The second vessel is preferably a stainless evaporation/vacuum vessel, but can be any vessel suitable for removing solvent from a mixture or solution. Generally, the solvent vapors coming off the mixture are routed through a loop and are cooled by water or an air cooler such that the condensed vapors are collected in a storage or collection vessel remotely from the oleuropein aglycon-rich mixture. This step of solvent removal is continued until the volume in the evaporation vessel is about one tenth the original volume. [0035] At this time, previously treated water is added to the vessel as necessary to precipitate oil and facilitate the total removal of solvent. The vessel is reheated to boiling with the solvent traveling through the same condenser loop to the solvent storage until the vapor temperature exceeds the boiling point of the solvent. The condensate is then directed back to the holding tank for the raw treatment of water until the consistency of the residue in the evaporation tank is a slurry or a pumpable mud. The slurry residue, which does not contain any solvent, is then pumped into pans for drying by the same means as in the first stage. The resulting product is about 40% oleuropein aglycon as determined by HPLC. Remaining solids are natural olive solids. [0036] The other remaining end products also have potential uses. For example, the solid residue from the extraction step is high in sugar and is a suitable supplement for animal feed or alcohol fermentation. (See Fig. II: Olive Water Treatment-Phase II; and Fig. III: Phase II)

1a

FIELD This present disclosure relates to orbital surface treatment equipment. More particularly, the disclosure relates to a drive system for equipment for polishing, grinding, or otherwise treating stone and masonry flooring surfaces. BACKGROUND Orbital floor grinders typically include an electric motor having an output shaft that extends through a drum assembly. The output shaft drives a belt that drives a plurality of treatment disks that contact the flooring surface. To improve handling of the machine and the treatment effects to the flooring, the orbital machine is typically configured to counter-rotate the drum housing relative to the direction of rotation of at least some of the treatment disks. The present disclosure relates to an improved configuration for rotating the drum assembly that avoids the need for a separate traveling belt for rotating the drum assembly. SUMMARY The disclosure advantageously provides a floor grinder having a rotatable drum assembly. In one aspect, the grinder includes a drum assembly having a driven pulley having a rotatable drive surface; a drive surface operatively associated with the drum assembly; and a drive unit for imparting rotation to the drum assembly. The drive unit includes a rotatable pulley positioned adjacent to and in contact with the rotatable drive surface of the driven pulley of the drum assembly and the drive surface of the drum assembly. The rotatable drive surface of the driven pulley is configured to impart rotation to the rotatable drive pulley during rotation of the rotatable drive surface. The rotatable drive pulley is configured to impart rotation thereof to the drum assembly. In another embodiment, the grinder includes a motor having a rotatable output shaft and a drum assembly. The drum assembly includes a drive pulley connected to the output shaft of the motor, a driven pulley, and a traveling belt travelable around the output shaft and the driven pulley and configured to have a direction of travel imparted to it by the output shaft during operation of the motor to rotate the output shaft. The driven pulley has a shaft extending above an exterior portion of the drum assembly to provide a rotatable drive surface. The grinder further includes a motor mount connected to the motor; a bearing between the motor mount and the drum assembly to enable the drum assembly to rotate relative to the motor; a drive surface operatively associated with the drum assembly; and a drive unit for imparting rotation to the drum assembly. The drive unit includes a rotatable pulley positioned adjacent to and in contact with the rotatable drive surface of the driven pulley of the drum assembly and the drive surface of the drum assembly. The rotatable drive surface of the driven pulley is configured to impart rotation to the rotatable drive pulley during rotation of the rotatable drive surface, and the rotatable drive pulley is configured to impart rotation thereof to the drum assembly. During operation of the motor, the output shaft rotates to travel the traveling belt and impart rotation to the driven pulley and the drive surface. The drive surface imparts rotation to the drive pulley, which imparts rotation to the drum assembly. In yet another embodiment, the grinder includes a motor having a rotatable output shaft and a drum assembly. The drum assembly includes a drive pulley connected to the output shaft of the motor, at least two driven pulleys, and a traveling belt travelable around the output shaft and the two driven pulleys and configured to have a direction of travel imparted to it by the output shaft during operation of the motor to rotate the output shaft. The traveling belt is arranged to impart travel to one of the driven pulleys in a direction corresponding to the direction of travel imparted to the traveling belt and to impart travel to the other one of the driven pulleys in a direction of travel opposite to the direction of travel imparted to the traveling belt, one of the driven pulleys having a shaft extending above an exterior portion of the drum assembly to provide a rotatable drive surface. The grinder also includes a motor mount connected to the motor; a bearing between the motor mount and the drum assembly to enable the drum assembly to rotate relative to the motor; a drive surface operatively associated with the drum assembly; and a drive unit for imparting rotation to the drum assembly. The drive unit includes a rotatable pulley positioned adjacent to and in contact with the rotatable drive surface of the driven pulley of the drum assembly and the drive surface of the drum assembly. The rotatable drive surface of the driven pulley is configured to impart rotation to the rotatable drive pulley during rotation of the rotatable drive surface, and the rotatable drive pulley is configured to impart rotation thereof to the drum assembly. During operation of the motor, the output shaft rotates to travel the traveling belt and impart rotation to the two driven pulleys and the drive surface. The drive surface imparts rotation to the drive pulley, which imparts rotation to the drum assembly. BRIEF DESCRIPTION OF THE DRAWINGS Further advantages of the disclosure are apparent by reference to the detailed description in conjunction with the figures, wherein elements are not to scale so as to more clearly show the details, wherein like reference numbers indicate like elements throughout the several views, and wherein: FIGS. 1 and 2 show a grinder according to the disclosure. FIGS. 3 and 4 are partially exploded views of the grinder of FIGS. 1 and 2 . FIG. 5 is a lower perspective view of a drum assembly of the grinder of FIGS. 1 and 2 . FIG. 6 is an exploded view of the drum assembly of FIG. 5 . FIG. 7 is a partially exploded view of the drum assembly of FIG. 5 . FIGS. 8 and 9 show a drum drive assembly of the grinder of FIGS. 1 and 2 . FIGS. 10 and 11 are partially exploded views of the drum drive assembly of FIGS. 8 and 9 . DETAILED DESCRIPTION With reference to the drawings, the disclosure relates to a grinder 10 having a motor 12 mounted by a motor mount 12 a onto a drum assembly 14 , with one or more drive units 16 located on the exterior of the drum assembly 14 for rotation of the drum assembly 14 . A bearing assembly 18 interfaces between the motor mount 12 a and the drum assembly 14 to enable the drum assembly 14 to rotate relative to the motor 12 . The grinder 10 may be integrated with a frame or the like having handles and controls for facilitating operation of the grinder 10 . The motor 12 is typically an electric motor. The motor 12 may have various motor power ratings, typically ranging between about 5 and 25 horsepower. The motor 12 is fixedly mounted to the motor mount 12 a , and the motor mount 12 a is rotatably mounted to the drum assembly 14 by the bearing 18 . The motor 12 includes an output shaft 12 b that is preferably driven at a variable rotary speed of from about 350 to about 1,400 revolutions per minute. The drum assembly 14 includes a top plate 20 and circumferential sidewall 20 a , a drive pulley 22 , a drive belt 24 , a plurality of idler pulleys 26 a - 26 c , a plurality of driven pulleys 28 a - 28 d , a bottom plate 30 , and plurality of driven disks 32 a - 32 d . A belt tensioner 34 is mounted to the underside of the top plate 20 to desirably adjust the tension of the drive belt 24 . The motor 12 is mounted to the exterior of the top plate 20 by the motor mount 12 a . The output shaft 12 b of the motor 12 extends into the drum assembly 14 via an aperture 36 centrally located on the top plate 20 . The drive pulley 22 operatively engages the output shaft 12 b of the motor 12 so as to rotate corresponding to the rotation of the output shaft 12 b . The drive belt 24 travels around the idler pulleys 26 a - 26 c and the driven pulleys 28 a - 28 d and transfers rotation of the drive pulley to the driven pulleys 28 a - 28 d . Together, the idler pulleys 26 a - 26 c and the belt tensioner 34 serve to provide desired tension of the drive belt 24 and contact of the drive belt 24 with the driven pulleys 28 a - 28 d . The drive belt 24 is the only traveling belt utilized on the grinder 10 . With reference to FIG. 5 , it will be observed that the drive belt 24 is arranged to contact the driven pulleys 28 a and 28 d such that the driven pulleys 28 a and 28 c each rotate in the same direction and opposite to the direction of travel of the drive belt 24 , and the driven pulleys 28 b and 28 d each rotate in the same direction and in the same direction of travel of the drive belt 24 . Thus, if the drive belt 24 travels counter-clockwise, the driven pulleys 28 a and 28 c each rotate clockwise and the driven pulleys 28 b and 28 d each rotate counter-clockwise. The driven pulleys 28 a - 28 d each include a downwardly extending shaft 38 that extends from the bottom of each of the driven pulleys 28 a - 28 d and passes through a corresponding aperture 40 of the bottom plate 30 . The driven disks 32 a - 32 d directly connect to the shafts 38 of the driven pulleys 28 a - 28 d adjacent the exterior surface of the bottom plate 30 , and rotate with the driven pulleys 28 a - 28 d . Various work pieces, such as grinding disks and the like, may be connected to the driven disks 32 a - 32 d for treating a flooring surface. Two of the driven pulleys, such as the driven pulleys 28 a and 28 c located opposite of one another, include upwardly extending shafts 42 that extend upwardly from the driven pulleys and extend through apertures 44 of the top plate. With additional reference to FIGS. 8-11 , the drive units 16 connect to and are driven by the upwardly extending shafts 42 of the driven pulleys 28 a and 28 c . In this regard, a gear pulley 46 is located on the shafts 46 to provide a rotary drive surface. Alternatively, the shaft 42 itself could provide the drive surface, or the shaft could be coated with rubber or the like to provide a drive surface. As described herein, the gear pulley 46 provides the drive surface. Each drive unit 16 includes an anchor plate 50 that mounts to the top plate 20 of the drum assembly 14 . The anchor plate 50 is connected by a spring loaded yoke system 52 to a pulley mount 54 . The drive units 16 are mounted onto the drum assembly 14 to drive the drum assembly in a direction opposite that of the rotation of the driven disks 32 a - 32 d. The anchor plate 50 may be an L-shaped metal plate having an aperture 50 a in for mounting of the anchor plate 50 to the top plate 20 as by use of a fastener. An upstanding portion of the anchor plate includes an aperture 50 b for mounting of the yoke system 52 to the anchor plate 50 . The yoke system 52 includes a yoke end 56 having a pair of arms 56 a and 56 b with aligned apertures for mounting of the yoke end 56 onto the pulley mount 54 . To enable some controlled lateral relative movement, a threaded bolt 58 adjustably connects to the yoke end 56 and a compression spring 60 is located on the bolt 58 opposite the yoke end 56 to bear against the anchor plate 50 . A compression spring 62 interfaces between the yoke end 56 and the pulley mount 54 for enabling controlled vertical movement of the pulley mount 54 relative to the yoke system 52 . The pulley mount 54 includes a frame 64 having an aperture 66 configured to receive the gear pulley 46 and configured to permit rotation of the gear pulley 46 as driven by the driven pulley 28 a or 28 c . The frame 64 is also configured to rotatably mount, preferably utilizing bearings or the like, a gear pulley 68 adjacent to and in frictional contact with the gear pulley 46 for being driven by the gear pulley 46 . In this regard, the gear pulley 46 and the gear pulley 68 may include surfaces configured to encourage frictional interaction, such as including rubberized surfaces and/or cooperating ridges 46 a and 68 a , respectively. The ridges 46 a and 68 a are shown partly around the circumference, it being understood that they may preferably extend around the circumference. As will be understood, the gear pulley 46 rotating in a first direction, such as clockwise, will impart a rotation to the gear pulley 68 in a second, opposite direction, such as counter-clockwise. The anchor plate 50 , yoke system 52 , and the pulley mount 54 cooperate to rotatably position the gear pulley 68 in contact with a circumferential surface 70 of the motor mount 12 a . The circumferential surface 70 is preferably coated with a rubber or like material to frictionally engage the gear pulley, yet enable some slippage if substantial counter-rotational forces are encountered. Alternatively, a replaceable fixed (non-traveling) belt or band or sleeve or the like may be located around the circumferential surface 70 to contact the gear pulley 68 . In operation of the grinder 10 , it will be understood that rotation of the output shaft 12 b is transferred by the drive pulley 22 to cause the drive belt 24 to travel and transfer rotation to the driven pulleys 28 a - 28 d , causing rotation of the driven disks 32 a - 32 d in a first direction, such as clockwise. The clockwise rotation of the driven pulleys 28 a and 28 c provides clockwise rotation of the gear pulleys 46 mounted thereon, which transfers an opposite rotation of the gear pulleys 68 . Thus, for example, clockwise rotation of the driven pulleys 28 a and 28 c provides clockwise rotation to the gear pulleys 46 . The clockwise rotation of the gear pulleys 46 imparts opposite or counter-clockwise rotation to the gear pulleys 68 . The gear pulleys 68 contact the circumferential surface 70 of the motor mount 12 b , imparting an opposite, clockwise motion to the drum assembly 14 . Accordingly, in operation, rotation of the output shaft 12 b of the motor 12 is transferred by the traveling drive belt 24 . The drive belt 24 transfers its rotation to the driven pulleys 28 a - 28 d to cause the driven pulleys 28 a and 28 c to rotate opposite of the direction of travel of the belt 24 , and the cause the driven pulleys 28 b and 28 d to rotate in the same direction of travel as the drive belt 24 . The rotation of the driven pulleys 28 a and 28 c rotates the gear pulleys 46 mounted thereto. The gear pulleys 46 contact the gear pulleys 68 of the drive units 16 to cause the gear pulleys 68 to rotate opposite of the driven pulleys 28 a and 28 c . The gear pulleys 68 contact the circumferential surface 70 of the motor mount 12 a to cause the drum assembly 14 to rotate opposite the direction of rotation of the gear pulleys 68 and in the same direction as the driven pulleys 28 a and 28 c . The driven pulleys 28 b and 28 d rotate opposite of the drum assembly 14 and the driven pulleys 28 a and 28 c. The foregoing description of preferred embodiments for this disclosure have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments are chosen and described in an effort to provide the best illustrations of the principles of the disclosure and its practical application, and to thereby enable one of ordinary skill in the art to utilize the disclosure in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the disclosure as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

1a

BACKGROUND OF THE INVENTION This invention relates to a method and apparatus for making a dough product including the inverting of the baked dough product prior to further processing. More particularly, this invention relates to the making of essentially hollow dough products with the inverting of the dough products prior to these products being filled. The present process and apparatus is particularly adapted to producing baked goods whereby after the baking step the baked good needs to be inverted prior to further processing. One particular use for the present method and apparatus is in the production of filled biscuit and cracker products. These types of filled biscuit and cracker products consist of snack items that are produced in various forms and which have essentially hollow centers. The hollow centers are produced through the utilization of specific doughs, through the use of particular processing, or through a combination of these techniques. In U.S. Pat. No. 4,613,508 it is disclosed that hollow formed biscuit products can be formed which undergo a leavening increase of at least 280. There has also been developed a cracker dough which as a result of the dough composition and subsequent processing will undergo a high level of expansion during baking to thereby create a large internal hollow space. It is this hollow space that is created primarily by the leavening agent during the baking operation that is subsequently filled with a suitable filling utilizing needle injection techniques. The filling of a hard biscuit or hard cracker using needle injection techniques consists of having a needle pierce the baked hollow form and after having pierced the form inserting therein the desired filling. Generally the filling step is conducted just subsequent to the baking step prior to any substantial cooling of the baked biscuit or cracker. At this point in the processing the biscuit or cracker retains more of its pliability and thus is not as susceptible to cracking as when the biscuit or cracker would be filled after it had been totally cooled. However, the biscuits and crackers can be filled after they have been cooled. In the filling of these baked forms it is preferred to fill the baked forms from the side that had contacted the oven during the baking operation. One reason is that the opposite side of the baked form will in many instances contain a design which is imprinted onto the upper side of the baked form prior to baking. That is, the design is on the side opposite that which contacted the bottom of the oven during baking. In this way the pin hole that would be formed during the filling of the baked form would not be made in the side of the baked form having the fanciful design. This consequently requires a technique for inverting the baked shape forms immediately after the baking step and just prior to the step of needle injecting the filling into the baked form. The above noted U.S. Pat. No. 4,613,508 discloses a method for producing hollow hard biscuit forms. These hollow baked forms will in many instances contain on one surface a fanciful design. Although these hollow baked forms can be filled from either side, it is preferred to fill the baked forms from the side not containing the design. This side will be the side that contacted the bottom of the oven during the baking of the hollow formed product. This patent does not address this issue and does not disclose from which side the hollow baked forms are filled, or from which side it would be preferred to fill the hollow baked forms. However, in the present processing it is clearly preferred to fill the hollow forms from what would be termed the bottom side in order not to disfigure the upper surface and any design which it carries. BRIEF SUMMARY OF THE INVENTION The present invention is directed to a method and apparatus for making a dough product and then inverting that dough product prior to subsequent processing of the baked dough product. The process steps consist of forming a dough, baking the dough to make a plurality of baked dough products, conveying the baked dough products to an inverter which consists of a wheel having a multiple number of longitudinal steps onto which the baked products can be fitted, rotating the wheel which carries the baked products, and depositing the baked products in an inverted mode on a lower table or conveyer belt mechanism. The inverted baked products are then passed for further processing. In a preferred embodiment the baked dough products are hollow formed baked biscuits or crackers. After the baked biscuits or crackers come from the oven they are conveyed via a conveyor having separate channels to the inverting wheel mechanism. The units of the baked goods fall into place onto the steps of the rotating inverting wheel which upon rotation deposits them in an inverted state on a lower conveyor belt which transports the hollow formed biscuits or crackers to an indexing mold which will hold the biscuits or crackers during the step that needles are moved vertically downwardly to pierce the surface of the biscuit or cracker and to deposit a particular filling into the inside of each biscuit or cracker. After being filled the now filled biscuits or crackers are removed from the indexing mold and are conveyed to packaging. The inverting apparatus consists primarily of a wheel having a multiple number of steps to hold the baked product while the wheel rotates and inverts the baked product. Also in combination with the wheel is a feed conveyor mechanism which channels the baked products into a series of channels so that they will be placed in an orderly manner on the steps of the rotating wheel. After leaving the rotating wheel in an inverted condition the inverted baked items are conveyed to a step of coating the items, inserting a filling into the items, or performing some other type of operation on the items. The step that would be performed after inverting, is not critical. The apparatus can have essentially any number of lanes in the feed conveyor to the rotating inverter wheel and will have essentially the same number of lanes on the conveyor mechanism which flow the inverted baked products from the inverter wheel. The conveyor mechanism to the inverter wheel and the conveyor mechanism from the inverter wheel are designed for the orderly flow of items to and from the inverter wheel. Consequently any appropriate design can be used. The number of steps on the inverter wheel will depend on the diameter of the inverting wheel and the size of the cookie or cracker to be inverted. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic stepwise layout of the process for making and filling a hollow baked type of bakery product. FIG. 2 is a top plan view of the apparatus for making and filling hollow baked form bakery products. FIG. 3 is a side elevational view of the inverter wheel that is utilized to invert the baked bakery products. FIG. 4 is a side elevational view of the indexing means along with the needles for inserting fillings into the baked bakery products of FIG. 3. DETAILED DESCRIPTION OF THE INVENTION One technique for introducing a filling into a hollow baked product is to introduce that filling into the intended hollow space utilizing needle injection. In needle injection a fine needle pierces the surface skin of a hollow biscuit or cracker, and via a pressure on a filling material, deposits this filling material into the inside of the hollow biscuit or cracker. It is notable in this technique that the filling is inserted into the baked product which has a hard exterior surface subsequent to the baking step. In order to effectively insert the filling into the baked forms at this point the exterior surface of the baked form must be sufficiently strong in order to withstand the piercing of the surface by a needle. This thus requires products which are formed from fairly specific dough formulations. This has already been discussed above in some detail. Dough formulations suitable for forming hollow biscuits are set forth in U.S. Pat. No. 4,613,508. Other dough formulations which are suitable for forming a hard cracker that can withstand the penetration of a needle are known in the art. Although the preferred embodiment in practicing the present invention is with regard to hollow biscuits and hollow crackers the process can be utilized with essentially any baked good. However, the preferred method is to make and to fill baked hollow forms of biscuits and crackers. The first step in any process consists of forming a suitable dough. This can be a dough formed in accordance with the process of U.S. Pat. No. 4,613,508 or that which is described in the example of this present application for patent. After the step of combining and mixing all of the ingredients forming the dough, which includes the forming of the dough into particular forms and shapes, such as the designs of animals, plants, or various articles, they are conveyed to a baking oven. However, prior to being baked the dough can also have a fanciful design embossed on one side. In the baking oven the forms are simultaneously baked and expanded. The doughs contain at least one leavening agent which during baking releases carbon dioxide which significantly expands the dough forms and aids in forming the hollow interior space. The temperature of the oven ranges from about 300° F. to about 700° F. The baking time will usually range from about 1 minute to about 15 minutes. This will depend on oven temperature and other factors. The baking temperature and baking times are interrelated. After baking, the baked forms leave the oven and are conveyed into a plurality of channels. In the plurality of channels the baked forms are moved along to an inverting wheel. The inverting wheel consists of a series of longitudinal stepped sections that are adapted to hold a plurality of the baked forms in each step area. Upon the rotation of the wheel the baked forms in each stepped section will be transferred to a lower conveyor belt in an inverted form. This lower conveyor belt will have a plurality of channels which direct the baked forms into an indexing mold. When each opening of the indexing mold has been filled with the baked forms a series of injecting needles extend downwardly to pierce each of the baked forms and to insert a filling into each of the baked forms. The now filled baked forms are removed from the indexing, mold and are conveyed to packaging. FIG. 2 sets forth an overall plan view of the present apparatus. The various expanded forms that are to be baked are conveyed into or placed into baking oven 9. In oven 9 the particular forms are baked and will expand during the baking process. Depending on the speed of the oven conveyor mechanism the time in the oven will range from about 1 minute to about 15 minutes. The hot baked and expanded forms 30 leave oven 9 and enter onto conveyor 10 which consists of a plurality channels 10a. The channels 10a are separated by barriers 10b. The function of the channels 10a are to align the baked forms into lines 30 so that they can be deposited in a reasonable order onto inverter wheel 12. Optionally just prior to inverter wheel 12 there can be a gate 11 which can be operated via a timer or via photoelectric mechanism to hold the shaped forms until there is a shaped form in each channel to be deposited onto the inverter wheel. The baked forms that are placed on the inverter wheel remain on the inverter wheel until they are deposited by gravity onto conveyor 13 in an inverted form. The steps of inverter wheel 12 are designated in this FIGURE. as 12a, 12b, 12c, 12d, 12e, 12f, 12g and so on. The number of step sections on inverter wheel 12 will depend on the circumference of the wheel and the size of the baked good to be inverted. The inverter wheel is rotated on axle 17 by means of an electric motor. The speed of the inverter wheel 12 can be controlled using a common rheostat. The baked and inverted items are deposited onto conveyor belt 13 in one of the conveyor channels 13a. These channels 13a are separated one from the other by means of barriers 13b. The conveyor 13 moves the now inverted baked forms 30 along to gate 14. Gate 14 lines up a plurality of the inverted baked forms 30 that are to be filled. This gate 14 will stay closed until there is a baked form abutting the gate in each of the lanes 13a. At this point in time the gate 14 is opened and an inverted baked form is deposited into each of the openings 15a in indexing mold 15. When each of the mold openings 15a is filled with a baked form, a series of needles 18 project downwardly to pierce the surface of the biscuit or cracker and to inject a filling into each of the biscuits or crackers. After the biscuits or crackers have been filled they are removed from the indexing mold 15 and conveyed by means of conveyor 16 to final packaging. The mold 15 is of a design where it has a series of openings, each adjacent to one of the channels 13a. Therefore when gate 14 opens a baked form 30 will move into a mold opening 15(a) by means of conveyors 13 and 16. The baked form will be held in the mold 15 until the forms are filled. The inverter wheel 12 is shown in more detail in FIG. 3. This wheel rotates on axle 17 and consists of a plurality of stepped sections which are designated 12a, 12b, 12c, 12d, 12e, 12f, 12g and so on. As noted above the size of each of these stepped areas will depend on the size of the item that is to be inverted. The number will depend on the circumference of the inverter wheel. The speed at which this wheel is rotated will depend to a large degree on the speed of the other operations under which the baked product must go. For instance, in the process of filling hollow biscuits and crackers the rate determining step is the step of piercing the biscuit or cracker with the needle and injecting the filling into the hollow form product. The production of other products will have other rate controlling steps. However, it will be rare that the rate controlling step will be the step of inverting the baked product. This step can be conducted quite rapidly. In making the present hollow biscuits and crackers the conveyor belt 16 is operated at a speed so as to provide a spacing between the biscuits or crackers as they exit the inverter wheel. It is desired to operate conveyor 13 at a higher speed so that the biscuits or crackers will not bunch up on conveyor 13. Conveyor 13 is carried by tensioning rollers 24 and 25. These rollers both tension and rotate belt 13. Conveyor 16 is carried by rollers 26 and 27. These rollers both tension and rotate belt 16. The injection apparatus consists of a pluralitY of needles 18 which are fed with an injection filling material from chamber 17. Chamber 17 receives the filling material from a supply through tubing 19. In the operation of the needle injection system the needle injector assembly will move upwardly and downwardly via shaft 20 which is connected to chamber 17 by clamp 23. When there is a biscuit or cracker in each of the mold openings 15a of mold 15 the needle injection system moves downwardly and injects a filling into each biscuit or cracker. The shaft 20 then retracts the needle injection system upwardly. The mold -5 will then also move upwardly and release the filled biscuits and crackers to move along conveyor 16 to packaging at 21. The mold 15 is raised and lowered by means of shaft 22. There is a coordination of the gate 14, the raising and lowering of mold 15 and the raising and lowering of the needle injectors 18. The inverting wheel can be made out of metal or out of various plastic materials. However, for durability and for ease of cleaning it is preferred that this wheel be constructed out of metal such as aluminum or stainless steel. FIG. 4 shows the indexing mold 15 and each of the openings 15a holding a cracker or biscuit for filling. Also shown is a series of needles 18 which are adapted to move downwardly to penetrate the biscuits or crackers and to inject the filling into the biscuit or cracker. After the biscuits or crackers have been filled they move along conveyor 16 to the point of packaging at 21. Conveyor 16 can be continuously moving as its operation can be coordinated with the needle injection filling mechanism. As has been noted this baking technique and in particular this inverting wheel mechanism is specifically adapted to the filling of hollow biscuits and crackers. The fillings that can be inserted into these hollow biscuits and crackers vary over a wide range. These can be fat and or sugar based fillings and include chocolate fillings, peanut butter fillings, fruit fillings, vegetable fillings, meat based fillings, cheese fillings, seafood based fillings, and essentially any substance that can be formed into a puree and injected through a needle mechanism. The injection can be conducted while the injecting material is at room temperature or an elevated temperature. An elevated temperature is used in many instances in order to decrease the viscosity of the filling material. While this inverting wheel has been specifically described with regard to filling hollow crackers or biscuits it can be used in any operation where a food product or essentially any other item needs to be inverted. What is required is an upper conveyor to convey the food product or other item to the inverting wheel, a stepped inverting wheel, and a lower conveyor to receive the food product or other item in an inverted manner. Once inverted essentially any operation can be performed on the food product or other item. Besides providing a method of making hollow filled crackers and biscuits it provides a unique technique for inverting items. EXAMPLE This example sets out a method of making and filling a hollow cracker using inverting wheel 12 to invert the hollow crackers. Based on 100 pounds of wheat flour, the ingredients are as follows: ______________________________________Shortening 8.5 poundsEmulsifier 0.375 poundsBarley Flour 0.0875 poundsGranulated Sugar 6 poundsSalt 0.75 poundsSodium Bicarbonate 0.75 poundsCalcium Acid Phosphate 0.625 poundsProteolytic Enzymes 0.19 poundsWater 32 pounds______________________________________ The shortening, emulsifier, granulated sugar, salt, calcium acid phosphate and water are added to a dough mixer and mixed until fully blended. The mixture of wheat flour, barley flour, sodium bicarbonate is then added to this mixture followed by the addition of the proteolytic enzymes dispersed in a small amount of water. This is mixed for about 8 minutes. After mixing, the dough is proofed for about 3 hours. Following this proofing the dough is mixed for 1 minute and proofed again for 1 hour. The dough is now machined so that it can be cut into the desired shapes. Machining consists of rolling the dough and folding the dough over onto itself to form a multilayered laminate of the dough. The dough is then sheeted to the correct thickness and cut into the desired shapes. The shapes are then fed to the oven where they are baked at 410° F. to form a hollow cracker 30. The baked crackers 30 are then conveyed from the oven on conveyor 10 and fed to inverter wheel 12. Upon the opening of gate 11 a series of hollow crackers are placed on a step of the inverter wheel. Upon the rotation of wheel 12 the hollow crackers drop onto conveyor 13 in an inverted state. The inverted crackers 30 move along conveyor 13 to gate 14. Gate 14 opens when there is a cracker in each lane and permits a cracker to fall into each mold opening 15(a). Each cracker is then injected with a filling and is then conveyed by means of conveyor 16 to packaging at 21.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of European Patent Application No. 11158806.7, filed Mar. 18, 2011, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] This technology generally relates to animal cages and more specifically to animal cage provided with special means for monitoring and controlling the cage micro-environment conditions. BACKGROUND OF THE INVENTION [0003] In the field of animal management, specifically that of laboratory animals, such as rodents, the environment inside the cages must be tightly controlled to prevent contaminations of the animals by the external environment and/or contamination of the environment and humans by the animals. [0004] Research animals are becoming more valuable because many disease models are expensive and time consuming to develop on animals and some animals may have gone through longitudinal studies accumulating valuable long term data from experiments thus making them extremely critical to basic science research and medical device and drug development programs. [0005] Most research institutions invest substantial resources to keep these valuable animal assets safe. A vivarium facility, including the shelving storage and the cages, is a repository where researches store their valuable animals. Individually ventilated cages (“IVC”) and rack systems are widely used for housing laboratory animals that enable a plurality of such animal cages to be arranged in a industrious and efficient manner. These systems are designed for providing a highly consistent environment across all cages on each rack. [0006] Nonetheless, it is not uncommon for one single rack to house animals from multiple study protocols that may have different controls and environmental requirements. Therefore, there is a need for a highly adaptable caging system that can provide researchers and vivarium management flexibility to accommodate such emerging market needs on a single rack system. [0007] Furthermore, some vivarium facilities support “long term studies”, where a “long term study” is defined as a research study that involves research animals monitored by recording devices and necessary equipment to collect data either continuously or at pre-set intervals from animals or from sensing instruments surrounding the animals. The duration of such studies may last for as little as a workday (at least 8 hours) or up to to the maximum lifespan of the animals being studied. [0008] Cage level monitoring devices have been evaluated and sometimes adopted on limited scale for decades to provide precise measures and controls of micro-environment and, in some cases, the animals inside. The basic concept of an operant cage is almost a century old. However, deploying active monitoring on a large and industrious scale has been inefficient and challenging because of cost and reliability issues. [0009] One challenging issue is to satisfy stringent cleaning requirements of monitoring and control equipment on large scale. Some electronic equipment is hard to decontaminate and other electronic equipment may not withstand harsh cleaning agents or methods. Increasingly, sophisticated animal models are developed with animals that have immune deficiency or multiple diseases, for example, making these animals extremely sensitive to the cleanliness of the cage micro-environment. A lot of resources are dedicated to minimize cross-contaminations between cages and cohorts of animals from different study protocols. Therefore, there is an unmet need for an efficient way to keep monitoring equipment and devices around and near each cage clean. [0010] Many modern vivarium facilities use sophisticated technologies to provide consistently high quality of care for these valuable animal assets. Besides housing, another concern is providing quality drinking water to every cage with methods such as water packs, automated filled water bottles, and automatic watering systems. These watering methods typically are very reliable. However, their failures can cause cage flooding which may lead to animal distress or even death from hypothermia or drowning. [0011] Therefore, there is a market need for a highly reliable and specific flooding detection and warning system to safeguard against potentially devastating loss of animal assets. Additionally, there is an unmet need for a cage provided with means suitable to automatically detect the bedding conditions in order to constantly control the environment of the cage. [0012] Lab animal housing requirements include both reducing research variations by employing strategies to provide consistent micro-environment of the cage and monitoring micro-environments to detect unexpected issues early so that expensive and valuable animal models are not lost. Such measures mitigate outbreaks and more actively and reliably control the cage/animal parameters. As research animals become more valuable, researchers are increasingly more interested in using monitoring equipment to extract useful data in a home cage environment. [0013] To increase capacity and quality for monitoring these valuable research animals, there are some basic needs such as water quality, safety to animals, and a direct control of the cage environment by monitoring both excessive water indicating cage flooding, and the bedding condition providing objective metrics for determining when to replace soiled bedding. SUMMARY OF THE INVENTION [0014] One object is to provide an animal cage provided with active monitoring and control of the micro-environment of the cage. [0015] Another object is to provide an animal cage with automatic detection system for monitoring cage conditions, i.e. soaking wet bedding, in order to promptly detect a flooding condition, and overly moist bedding being an indication for changing soiled bedding. [0016] Another object is to provide an animal cage adapted to be associated to an animal caging containment system, i.e. a rack, a platform, or a supporting structure in general, provided with system means suitable to interact with the bedding conditions detection means of the cage. [0017] These objects, and others that will be more clear in view of the detailed description, are achieved by an animal cage provided with specially designed features in order to active monitoring and control the micro-environment of the cage. BRIEF DESCRIPTION OF THE DRAWINGS [0018] Further characteristics and advantages of this invention will become clear from the following detailed description that is merely illustrative and not limitative and is shown in the figures that are attached hereto, in which: [0019] FIG. 1 shows a cross section of a lateral view of an exemplary animal cage, the cage being assembled on a single place-rack specially designed to receive such a cage; [0020] FIG. 2 shows the bottom surface of an exemplary animal cage; [0021] FIG. 3 shows a cross section of a lateral view of an exemplary animal cage, the cage being assembled on a single place-rack specially designed to receive such a cage; [0022] FIG. 4 shows a simplified lateral sectional view of an exemplary base part of an exemplary animal cage; [0023] FIG. 5 shows a perspective view of an exemplary animal cage inserted in a single place-rack; and [0024] FIG. 6 shows a detail of an exemplary cover of an exemplary animal cage. DETAILED DESCRIPTION OF THE INVENTION [0025] According to one exemplary embodiment of the present invention, as illustrated in the identified figures, the animal cage 100 includes a base part 120 and a top or lid 110 . The base part 120 is provided on the bottom wall 121 thereof, with cage means 101 for automatically detecting the cage condition. [0026] In more detail, the cage means 101 are suitable to detect the bedding condition, in particular with reference to the moisture degree of the bedding, and/or to detect the presence of water in a cage even in the case that the cage is not filled with bedding material. [0027] By monitoring the impedance of said cage means 101 , it is therefore possible to instantly and reliably detect the humidity level of the bedding and/or to promptly detect a flooding condition. [0028] In more detail, such cage means 101 includes at least two electrodes provided on the bottom of the base part 120 of the cage. [0029] The exemplary cage means 101 includes at least a pair of electrodes. Each pair of electrodes allows interrogation of the average electrical properties of materials between the electrodes. The electrodes are made of a highly conductive material, e.g. a metallic material. In general, this invention enables measuring impedance (with direct current DC and/or alternating current AC) of the target material inside the cage. Different frequency may be used with the same set of electrodes to measure different aspects of the condition inside the cage. [0030] The electrodes should be positioned on the external surface of the bottom wall 121 of the base part 120 of the cage, projecting inside the cage. [0031] In one form, electrical resistance can be used to measure humidity condition of the bedding, i.e. to monitor the moisture and, therefore, the dirtiness of the bedding. Additionally, the electrical resistance can be used to measure and promptly detect excessive water being accumulated inside the cage. [0032] One exemplary embodiment uses two electrodes which could be in the form of buttons or pins 101 , spaced by approximately 50 mm and projecting inside the cage in the region of the automatic watering system device 30 . [0033] On the external side of the cage, said buttons or pins 101 are electrically isolated from the cage by means of elastomeric washers, thus not compromising the possibility for the cage to be autoclaved during standard sterilization process. [0034] The cage means 101 for automatically detecting the cage condition are coupled, when the cage is inserted for example in an animal caging system 1 , to system means 40 for the automatic detection of the cage condition. [0035] The caging system 1 may be a rack comprising a plurality of single place stations or a single place-rack, suitable to receive a single cage 100 . [0036] According to one exemplary embodiment, the system means 40 may for example comprise an electro-conductive plate 40 adapted to contact both said buttons or pins 101 , thus closing the electric circuit between the pins 101 and measuring the electric resistance between the pins. [0037] The cage means for automatically detecting the cage condition can therefore detect both water accumulation, e.g. a flooding or a potentially dangerous water accumulation inside the cage, with or without bedding, and an overly moist bedding condition, which is an indication for changing soiled bedding. [0038] Since most drinking water contains trace level of mineral salts, the pins allow the current passage, and therefore the electric resistance between the pins can be measured, even in the case that the cage is not filled with bedding. [0039] Note that cage flooding usually happens when there is a sudden increase in the amount of water inside the cage due to malfunction of the drinking water source. One aspect of the invention is to measure the rate of the resistance changes over time. A rapid decrease in resistance would indicate a possible cage flood. [0040] Such detection would be monitored by an external controller which can be connected to a warning system typically found inside a vivarium facility. [0041] In one exemplary operation, the effects of dry and wet bedding inside a cage equipped with electrodes have been compared. With dry bedding, the measured resistance is about 50 MOhm, while soaking wet bedding, the resistance is about 50 kOhm. The difference in the measured values is a few orders of magnitude. Therefore the bedding condition can detected based on such measured values. [0042] Additionally, measuring of the electric resistance between the pins of the cage can be used not only to detect a flooding condition of the cage but also to provide a relatively reliable indication of the bedding condition. [0043] It is common for vivarium facilities to schedule periodic changing of the bedding, such as every fourteen days for IVC. In order to change the bedding of the cage, the cage can be removed from the rack and the animals can be moved from the old cage to a new one, filled with dry bedding material, at a predetermined time, regardless of the real condition of the bedding. Such unguided process can generate a large volume of waste bedding and consume significant amount of resources. Therefore, a more objective means for monitoring bedding condition can reduce wasting resources. [0044] Exemplary means for automatically detecting a cage condition is to measure the electric resistance between the pins 101 which detects the effective bedding humidity level. The resistance change associated with bedding condition derives from the accumulation of minerals typically associated with urine and waste materials from animals. The process for generating such materials is significantly slower than that from cage flooding. By differentiating the timed response for such resistance change, the vivarium staff is provded an objective measure for detecting soiled bedding condition associated with a slow response, and a possible cage flood often associated with a rapid response. [0045] In one exemple, a couple of electric tabs or tongues, electrically isolated one from each other, are provided inside the cage, each contacting one of said pins 101 . Through said tongues the electric signals are carried, through the pins 101 , outside the cage. [0046] The electric resistance of the bedding can be measured at a predetermined time interval, e.g. every half an hour, thus avoiding the possibility to altering the cage conditions, even if the voltage is very low, including between 1.5 and 3 Volts. [0047] The cage condition, bedding moisture level, and/or flooding condition can therefore be checked automatically and relatively reliably by means of the electric signal provided by the system 40 and cage 101 means, allowing the relatively immediate and effective detection of a potentially dangerous condition. [0048] As an example of possible connection of the cage with a specially designed single-place station or rack, reference is made to FIGS. 1 and 3 , in which the cage 100 is placed on a station or a rack equipped with sensors in its single place. An automatic watering device 30 is inserted in the cage itself, thus allowing the watering of the animals. [0049] The cage is therefore provided with an opening 102 suitable to receive the watering device 30 , while in the area below the watering device 30 , the cage is provided with the cage means 101 for automatically detecting cage condition, in the bottom wall 121 of the cage. [0050] In order to measure the electric resistance between the pins 101 , the cage place is provided with system means 40 for the automatic detection of the cage condition. [0051] Such system means 40 can include, in one example, a metal plate 40 connected to a specially designed electric circuit and suitable to contact both the pins 101 in the lower region of the cage. [0052] As per the description above, at least two electrodes can be placed at the cage floor. The electrodes are made of highly conductive materials (e.g. metal) that allow electrical current and can resist typical cage cleaning processes. Furthermore, the electrodes can be placed strategically to optimize the sensitivity and specificity of the parameters of interest for measurements. [0053] If the objective is to measure the water accumulation inside a cage, it is possible to provide a bevel or ramped cage bottom 121 ′ so that the water would accumulate at the valley of the bevel and the electrodes are placed strategically there to detect water accumulation. The bevel/ramp can have a very gentle slope so that it would not create a stressful environment for animals. [0054] According to one aspect, the terms “inclined” or “ramped” or similar terms are intended with respect to the horizontal plane, in a condition in which the cage is associated to the rack or to the single place station of the facility. [0055] A first example of such cage design in which the bottom of the cage has a gentle slope with respect to the horizontal plane is shown in FIG. 3 , in which the bottom surface 121 ′ of the base 120 of the cage is inclined with respect to the horizontal plane. [0056] In another example, each electrode can be placed at one valley on the cage floor. There can be a small hump or hill between the two valleys thus creating a physical threshold below which there would not be an electrical connection. With this design, the electrical connection can be detected only when there is a sufficient amount of conducting material (e.g. water) rising above the threshold to close the circuit. This feature can minimize false alarms. [0057] FIG. 4 shows another exemplary embodiment of the base part of an exemplary cage, in which the bottom surface has a profile which includes two ramped sections 121 ″ and 121 ′″ each one inclined with respect to the horizontal plane so that gentle slopes draw excess fluid or water to a valley where the electrodes 101 are located. [0058] The valley is placed at the front portion of the cage so that excess water is channel there to trigger off flood detection system thus keeping dry the back portion of the cage where animals typically like to stay. [0059] In another exemplary embodiments, multiple electrodes can be provided. One arrangement is, for example, to have four electrodes, each placed close to one corner of the cage. This arrangement would allow for a better spatial mapping of the wetness inside cage. This could potentially compensate for potential issues such as the cage bottom not perfectly flat or uneven distribution of bedding effecting electrical signal. [0060] A control unit can interrogate whether electric current is passed between electrodes to detect impedance of materials between electrodes. [0061] Interrogating electric current does not have to run continuously but at a sampling rate that is meaningful to obtain the desired information on the status of cage. [0062] In case the rack or the single place on which the cage is inserted is provided with one or more sensors 10 suitable for measuring the environmental parameters inside the cage, the top 110 of the cage 100 may be provided with sensor holes 111 , 112 , as shown on FIG. 6 , which allow the possibility to positioning at least part of the sensors 10 inside the cage. [0063] Having thus described the basic concept of the invention, it will be rather apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only, and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and scope of the invention. Additionally, the recited order of processing elements or sequences, or the use of numbers, letters, or other designations therefore, is not intended to limit the claimed processes to any order except as may be specified in the claims. Accordingly, the invention is limited only by the following claims and equivalents thereto.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to co-pending German Patent Application No. DE 10 2005 017 204.0 entitled “Schutzvorrichtung und Verfahren für das Einfüchren eines langgestreckten Instruments in einen Arbeitskanal”, filed Apr. 14, 2005. FIELD OF THE INVENTION [0002] The present invention generally relates to an endoscope for multiple use for medical purposes in a body of a mammal. Furthermore, the present invention relates to a method for using such endoscope. More particularly, the present invention relates to an endoscope with an optical fiber located in a working channel of the endoscope wherein an inner wall limiting the working channel is protected against damages caused by a distal end of the optical fiber. The endoscope might be an ureterorenoscope. Besides the aforementioned use of the endoscope the endoscope might also be used in other technical fields and appliances besides medicine. BACKGROUND OF THE INVENTION [0003] When using flexible endoscopes in medical endoscopy one or a plurality of working channel(s) is limited by a tube or sheet made of plastic. One such channel is used for visually inspecting a target area and/or the path the endoscope takes inside a body. Other working channels might be used for delivering a transparent fluid for rinsing the target area of the endoscope, in particular the target area of a minimal invasive surgical operation. Furthermore, it is possible to use the working channels for introducing additional instruments, in particular instruments used for surgery. Such instruments include micropliers, guiding wires, small baskets for recovery of particles or material from the target area, e.g. smashed or wrecked urinary stones, as well as light transmitting fibers, in particular fibers transmitting the light emitted by a laser. It is one drawback of the known endoscopes that the flexibility of an endoscope might be reduced in an operational state by an instrument extending at least partially through the working channel. In order to avoid problems caused by such reduced flexibility the endoscopes are commonly introduced in a body without an instrument extending through the working channel. Subsequent to introducing the empty endoscope into the body the instruments are introduced into the working channel. Also from other reasons it might be necessary to introduce instruments into the working channels of an endoscope after inserting the endoscope inside a body. On example is a visual investigation of the lower calyces renales by a flexible ureterorenoscope in order to locate nephroliths and for subsequent fragmentation of the nephroliths and/or removal of the nephroliths. In such procedure it is helpful for the purpose of detecting the nephroliths to maintain an unlimited flexibility of the flexible ureterorenoscope using the whole lumen of the working channel for rinsing the optical target area. This means that an instrument used for subsequent fragmentation or retrieval of the nephroliths should not be introduced into the working channel of the ureteror-endoscope when trying to detect the nephroliths. It is preferred to use energy supplied by a laser and transmitted or delivered by a fiber for the fragmentation of nephroliths or urinary calculus. Such fiber usually comprises a distal end cut perpendicular to its optical axis in order to provide optimal contact of the blunt distal end with the urinary calculus that is to be fragmented. In spite of the used fibers being designed to reduce the flexibility of the endoscope as little as possible, introduction of the fibers into the working channel of a flexible endoscope still involves problems. Due to a remaining small stiffness of the fiber, in particular a glass fiber, a sharp end of the distal end of the fiber scratches or cuts the wall that limits the working channel. Such undesired effect causes damages of the surface of the inner wall of the endoscope or the fiber. The damages in particular occur in curved portions of the working channel. For a long term use, such effect might cause failure of the endoscope. In practice, up to every second maintenance work for flexible endoscopes is due to damages of the working channel caused by an introduction of an instrument or a fiber into the working channel. Each of such maintenance works might cause costs of more than US$1,000. [0004] Whereas the present invention relates to endoscopes for multiple use with at least one lumen used for transmitting an optical signal to the physician, US 2003/0236517 A1 relates to a medical device for treatment of blood vessels using an introducer catheter for applying endovascular laser therapy. Usually, such introducer catheters are designed for single use due to the low costs of such catheter involving less costs for using a new catheter for the next body to be treated than disinfecting a used catheter. Such single use catheter comprises a protective sleeve with a single lumen with the optical fiber positioned therein. When moving the fiber through the working channel of the catheter, the distal end of the fiber is located inside the flexible sleeve such that a distal end of the flexible sleeve covers the edges built by the distal end of the fiber. In such manner, any damages of the limiting wall of the working channel are avoided. For a treatment of a saphenous vein, a small gauge needle is used to puncture the skin and access the vein. A guide wire is advanced into the vein through the lumen of the needle. The needle is then removed leaving the guide wire in place. A hemostasis introducer sheet is introduced into the vein over the guide wire and advance to 1 to 2 cm below the sapheno-femoral junction. A valve gasket provides a leak-proof seal to prevent a backflow of blood out of the sheet's proximal opening while simultaneously allowing the introduction of the fiber into the sheet. The valve gasket is made of elastomeric material such as rubber or latex. The gasket opens to allow insertion of the optical fiber and then seals around the protective sleeve containing the optical fiber. When inserting the optical fiber into the vein, the distal end of the fiber is protected by the protective sleeve. The distal end of the fiber embedded in the protective sleeve is inserted into the hemostasis sheet and advanced forward through the sheet lumen. As the protected fiber assembly is advanced through the curved pathway of the sheet shaft, the non-traumatic sleeve tip rather than the sharp edge of the optical fiber comes in contact with the inner sheet wall. Advantageously, the sleeve tip does not damage the inner wall of sheet shaft as it is advanced because of the sleeve's flexible material characteristics as well as because of its tapered or radiuses, non-traumatic distal profile. Moreover, the device eliminates the shavings of material of the working channel that may be cut away from the inner wall of the sheet shaft as an unprotected fiber tip is advanced. Accordingly, there is no risk of shaft material being deposited within the venous system or becoming adhered to the flat face of the optical fiber when the protective fiber assembly is used for transmitting laser energy. The fiber and the protective sleeve are advanced through the working channel until a connecting element comes in contact with a handle of the catheter. Once fully assembled the handle restricts relative movement of the protective sleeve with respect to the fiber as well as the working channel to a small range. Such range comprises a first limiting position correlating with an operational state wherein the distal end of the optical fiber is located inside the flexible sleeve. A second limiting position correlates with another operational state wherein the distal end of the optical fiber protrudes from the distal end of the protective sleeve. Once the physician has confirmed that the tip of the optical fiber is correctly positioned approximately 1 to 2 cm below the saphenous-femoral junction the device is placed in an operating position with the distal end of the fiber located outside the sleeve. The distal end of the fiber is exposed by retracting the connecting distal handle component while holding the proximal handle component stationary. The device is then in operating position, ready to delivery of laser energy to the diseased vein. After such treatment of the target area by the energy of a laser the catheter is then slowly withdrawn through the vein, preferably at a rate of 1-3 mm per second. [0005] Further prior art is known from U.S. Pat. No. 2,571,653, U.S. Pat. No. 3,809,072 and U.S. Pat. No. 4,886,049. SUMMARY OF THE INVENTION [0006] In the past, the conflict between mobility of flexible ureterorenoscopes and laser fibers required a two-step procedure: For diagnosis, localization and identification of stones in the lower calices the unrestricted mobility of the instrument's flexibility has to be available. Accordingly such steps were performed with an “empty” working channel having a large flexibility. For fragmentation of urinary stones a minimum of 15-20 Watt of laser power is required. Unfortunately, in the physics of some lasers there is limit in reducing the fiber diameter. Also very thin laser fibers are delicate and may break in use or even before they are used. Hence for stone therapy laser fibers with an optical core of 20 to 30 μm are common. However, even fibers at this diameter reduce the mobility of the ureterorenoscope due to their stiffness and friction in the working channel. Following the decision for laser fragmentation the flexible ureterorenoscope needed to be straightened again and the laser fiber was forwarded. Forwarding a laser fiber into a deflected or curved ureterorenoscope may immediately cause damage to the working channel because of the sharp silica glass at the distal end of the fiber. Therefore the surgeon will straighten the ureterorenoscope again after the stone has been located in order to insert the laser fiber without damaging the working channel. Subsequently, a second search for the stone with the laser fiber protruding out of the instrument is undertaken. During the second search the mobility of the ureterorenoscope is restricted because of the fiber being inside the working channel. Also the fiber needs to protrude out of the ureterorenoscope and while manipulating the instrument the tip of the fiber may cause trauma and bleeding which impairs the endoscopic view. As a result, the required time for the second search for the stone is about the same as for the first search which extends the operational time considerably. [0007] The present invention has identified a simple requirement: it needs to be feasible to insert a laser fiber for stone therapy into any deflected ureterorenoscope without causing damage to the working channel and without having an impact on the deflection of the ureterorenoscope in order to maintain the visual contact to the stone. [0008] On the basis of the invention the aforementioned straightening in a second step is not necessary any more. According to the invention, still outside of the ureterorenoscope the laser fiber is inserted into the flexible sleeve until the tip of the fiber stands approximately 2 to 5 mm behind the distal tip of the flexible sleeve. In this position, a Touhy Borst adapter at the proximal end of the flexible sleeve might be locked to the fiber. The combination of the flexible sleeve and the laser fiber is inserted into the deflected ureterorenoscope and forwarded until it appears in the endoscopic view. During insertion into the ureterorenoscope the flexible sleeve is leading with respect to the laser fiber by a few millimeters. Therefore, any contact of the laser fiber to the working channel and damage is prevented. Due to appropriate selection of the materials for the flexible sleeve there might be avoided any noticeable friction. Finally, the Touhy Borst adapter is opened and the laser fiber is forwarded the last few millimeters towards the stone. [0009] The use of the flexible sleeve might cause savings of approximately 70% of the repair works for damaged ureterorenoscopes. On the other hand, the use of the flexible sleeve is saving theater time because the second search for the stone is not required any more. Furthermore, the use of the flexible sleeve might also encourage the use of holmium lasers for the therapy of lower calyx stones in conjunction with flexible ureterorenoscopes and to reduce the surgeons fear of destroying a valuable instrument. [0010] According to the invention the relevant device is an endoscope for multiple use. Such endoscope comprises a working channel, an optical fiber having a distal end and a flexible sleeve. The flexible sleeve has an inner lumen for receiving said optical fiber. The flexible sleeve is axially movable relative to the working channel and relative to the optical fiber. The endoscope is designed and arranged for allowing a reciprocating movement, in particular a repeated movement in forward and backward direction throughout one procedure of treating a human body. The movement results in a first operational state of the endoscope wherein the distal end of the optical fiber is located inside the flexible sleeve. Quite similar to US 2003/0236517 A1 the first operational state corresponds to a protected state which allows an introduction and a withdrawal of the optical fiber embedded into the flexible sleeve into the working channel. Furthermore, the movement results into a second operational state wherein the flexible sleeve is completely removed from said working channel. This means that differing from US 2003/0236517 A1, it is possible to free a lumen built between the wall limiting a working channel and the outer circumference of the optical fiber from the protective sleeve. This is possible with the endoscope located inside the body. Such freed lumen might be used for introducing additional instruments into the endoscope for manipulating a target area of the endoscope. However, it is also possible to use such lumen for introducing a fluid for rinsing the target area of the endoscope or the optical fiber. Whereas according to US 2003/0236517 A1 such lumen is blocked by the protective sleeve causing the need for additional lumen in case of a fluid being delivered to the target area, the embodiment of the invention might lead to a very smart design of the endoscope with small outer diameters of the endoscope. Furthermore, fluid might be supplied with large volumetric flows wherein the fluid exits the endoscope close to the optical fiber and the target area. Additionally, it has been observed that the flexible sleeve located inside the endoscope might change the mechanical properties of the endoscope by enforcing the endoscope and increasing the stiffness of the endoscope. Such stiffening effects can be avoided by removing the flexible sleeve when transferring the endoscope in the second operational state. Nevertheless, it is also possible to provide an endoscope according to the present invention with additional lumens. [0011] The optical system for inspecting the target area of the endoscope and for finding a desired path in the body might be located in the same lumen as the optical fiber or might be located in an additional or main lumen. [0012] Accordingly for one embodiment of the invention the endoscope comprises a first lumen containing an optical system for guiding the endoscope and/or inspecting a target area inside the body and an additional second lumen for inserting a fiber with the protective sleeve and transmitting light from a laser source via the fiber. [0013] According to another embodiment of the invention, the endoscope comprises a third operational state. In such third operational state, the flexible sleeve extends through said working channel but said distal end is located outside said sleeve. Such third operational state more or less correlates with the operating position according to US 2003/0235617 A1. Such third operational state provides an endoscope with increased stiffness due to the small stiffness of the sleeve. However, the whole flexible sleeve might also be completely removed from the working channel when transferring the endoscope into the second operational state. According to such embodiment, a multifunctional use of the endoscope is possible providing the possibilities of adapting the endoscope to different types of use and conditions inside the body of a human being. [0014] For completely removing the flexible sleeve from the working channel, another embodiment of the invention suggests to use a slotted flexible sleeve. When retracting the sleeve from the endoscope, the sleeve might be separated from the optical fiber in the exit region of the flexible sleeve from the working channel by passing the fiber through the slot. For reintroducing the flexible sleeve into the working channel, the distal end of the slot is passed over the optical fiber and then subsequently introduced into the working channel. [0015] According to an alternative embodiment of the invention, the length of the optical fiber is longer than the double of the length of the maximum of the length of the sleeve and the length of the working channel. This means that the flexible sleeve might be completely withdrawn from the endoscope while still housing the optical fiber. Throughout further medical procedures, the flexible sleeve is left in such position containing the optical fiber. After finishing the medical procedure, the flexible sleeve is moved in distal direction reintroducing the flexible sleeve into the working channel. [0016] According to another embodiment of the invention, the flexible sleeve is made of PTFE. Such material is very robust and durable. Furthermore, PTFE comprises a very low friction coefficient. Additionally, the static friction coefficient of PTFE might equal the dynamic friction coefficient such that stick-slip-movements might be avoided by use of such material. PTFE is also a robust material when used in combination with acid or alkaline materials. [0017] In another aspect of the invention, the flexible sleeve has a slanted distal tip. Such slanted distal tip has the effect that curvatures of the working channel being directed in the same direction as the slanted tip might be followed by the whole abutting face of the distal end resulting in smaller surface pressure at the limiting wall of the working channel. This leads to a reduction of damages of the limiting wall. However, also in cases of the curvature of the working channel being directed in opposite direction to the slanted distal tip, the edge of the distal tip contacting the limiting wall of the working channel is not supported by the whole cross-section of the flexible sleeve but the remaining reduced cross-section of the slanted distal tip. This means that the forces necessary to deflect the distal tip for an adaptation to the curvature are reduced compared to an unslanted distal tip which again leads to a reduction of damages of the limiting wall of the working channel. [0018] For a method for using an endoscope according to the invention, in a first step the optical fiber is embedded in the flexible sleeve in a first operational state wherein the distal end of the optical fiber is located inside the flexible sleeve. Then, the flexible sleeve with the optical fiber embedded therein is introduced into a working channel of the endoscope. The flexible sleeve is moved relative to the optical fiber and relative to the working channel until a second operational state is reached. In such second operational state the whole flexible sleeve is located outside the working channel. Access is given to a lumen by removing the flexible sleeve from the interior of the working channel. Such lumen is limited by a wall limiting the working channel and limited by the outer circumference of the fiber. Such lumen is then used or for a diagnostic purpose or for a therapeutic purpose, e.g. for introducing an instrument into said lumen or for using the lumen for delivery or collection of a fluid. Afterwards, the flexible sleeve is reintroduced into the working channel. Then, the flexible sleeve with the fiber located therein is removed from the endoscope. Here, it is possible first to remove the endoscope from the body and afterwards removing the flexible sleeve from the endoscope. However, it is also possible first to remove the flexible sleeve from the endoscope and then to remove the endoscope with decreased stiffness from the body. [0019] One component of the endoscope according to the invention is a flexible sleeve embedding or covering the distal end of the fiber such that during introduction of the fiber into the working channel, the distal end of the protective sleeve protrudes from the distal end of the fiber. Accordingly, the distal end of the fiber does not directly contact the wall limiting the working channel when introducing the fiber into the working channel. However, the flexible sleeve covers any sharp edges of the distal end of the fiber. Additionally, the protective sleeve protrudes from the distal end of the fiber. Accordingly, the distal end of the flexible sleeve approaches any curved regions of the working channel prior to the distal end of the fiber approaching these regions. Accordingly, the flexible sleeve adapts to any curvatures of the working channel before the distal end of the fiber inside the flexible sleeve approaches these curvatures. With other words, the wall limiting the working channel only leads the flexible sleeve when introducing the fiber in the curved regions of the working channel instead of guiding the sharp distal end of the fiber. Furthermore, the proximal end region of the flexible sleeve protrudes from the working channel providing access for the physician to the sleeve for manipulating the position of the sleeve with respect to the fiber as well as the working channel. For the fiber located in the target area, such manipulation allows pulling back the flexible sleeve such that the distal end of the fiber is located outside the sleeve. In such operational state, energy might be activated and delivered by the fiber to a target area. [0020] The proximal end of the flexible sleeve might be equipped with a fixing device. Such fixing device is used for temporarily fixing the relative position of the fiber inside the flexible sleeve. Such fixation might be used when introducing the unit of flexible sleeve and fiber into the working channel. Furthermore, it is possible to fix the distance of the distal end of the fiber protruding from the flexible sleeve in the third operational state. It is preferred to choose a material for the protective sleeve with a sufficient sheer strength. The distance the sheet protrudes from the distal end of the fiber in the first operational state might be some millimeters, e.g. in the range of 1 to 5 mm. [0021] The outer diameter of the flexible sleeve should be smaller than the inner diameter of the working channel. Furthermore, the inner diameter of the protective sleeve should be chosen to be larger than the outer diameter of the fiber. Such dimensions reduce friction between the working channel and the flexible sleeve as well as between the flexible sleeve and the fiber. Additionally, the friction depends on the material of the flexible sleeve. Here, a material with a low friction coefficient should be chosen. Furthermore, a material with a large flexibility with respect to a lateral deflection of the flexible sleeve should be chosen. Additionally, the flexibility might be influenced by the dimension of the wall thickness of the flexible sleeve which might be chosen in the range of approximately 0.5 th to 2 th of a millimeter, in particular 1 th of a millimeter. [0022] The flexible sheet might be chosen to be a tube. The fiber might be a fiber for transmitting light with a blunt end region. In particular, the fiber could be a cut glass fiber with a sharp leading edge. [0023] The working channel for housing both the fiber and the flexible sheet is preferably part of a flexible endoscope and might be built by a tube made of a flexible plastic material. [0024] Other features and advantages of the present invention will become apparent to one with skill in the art upon examination of the following drawings and the detailed description. It is intended that all such additional features and advantages be included herein within the scope of the present invention, as defined by the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0025] The invention can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. In the drawings, like reference numerals designate corresponding parts throughout the several views. [0026] FIG. 1 shows the proximal end region of a fiber and a flexible sleeve surrounding the fiber prior to introduction into a working channel. [0027] FIG. 2 shows a distal end region of the fiber and the flexible sleeve according to FIG. 1 during introduction and advancement in a working channel in a curved region of the working channel. [0028] FIG. 3 shows the distal and proximal end regions of the working channel, wherein the fiber protrudes with its distal end from the distal end region of the working channel, the distal end region of the fiber being located adjacent to an urinary stone wherein the flexible sleeve is retracted to free the distal end region of the fiber. [0029] FIG. 4 shows a configuration similar to that of FIG. 3 , wherein the flexible sleeve is completely pulled back in proximal direction and removed from the working channel. [0030] FIG. 5 shows a slanted distal end region of a flexible sleeve with a fiber located therein during advancement of the flexible sleeve and the fiber through a curved region of the working channel. [0031] FIG. 6 shows a slanted distal end region of a flexible sleeve with a fiber located therein during advancement of the flexible sleeve and the fiber through a region of the working channel with changed rotational angle of the flexible sleeve. DETAILED DESCRIPTION [0032] Referring now in greater detail to the drawings, FIG. 1 illustrates an oblong instrument 1 which in the present case might be a fiber or glass fiber for transmitting light emitted by a laser. The oblong instrument 1 is designed and arranged to be introduced into a working channel 2 . The working channel 2 in particular is built by a flexible endoscope, e.g. a ureterorenoscope. Such working channel 2 is arranged parallel to an optical main channel of the endoscope. In order to provide the possibility to introduce instrument 1 into the working channel 2 , the distal end region 3 of instrument 1 is covered, jacketed or housed in the flexible sleeve 4 or flexible tube, wherein the distal end region of the flexible sleeve 4 protrudes from the distal end region 3 of instrument 1 . The proximal end region 6 of the flexible sleeve 4 is fixed at instrument 1 or pressed against instrument 1 which is indicated by arrows in FIG. 1 . In case of the flexible sleeve 4 having a sufficient sheer stiffness or longitudinal stiffness, the fixation of the flexible sleeve at its proximal end region 6 guarantees that the distance the distal end region 5 protrudes from the distal end region 3 of instrument 1 does not vary. [0033] FIG. 2 shows the flexible sleeve 4 when introducing the flexible sleeve 4 with an instrument 1 located therein into a curved region of the working channel 2 . In such curved region, there is the danger of “shaving”, cutting or abrading the limiting wall 8 of the working channel 2 by edges of the distal end region 3 of instrument 1 which might cause damages of working channel 2 . The flexible sleeve 4 provides a lateral cover for the distal end region 3 of instrument 1 . Additionally the distal end region 3 is guided by the protruding distal end region 5 of flexible sleeve through the curved region of the working channel. The limiting wall 8 of working channel 2 deflects the flexible protruding distal end region 5 of flexible sleeve 4 when advancing instrument 1 by pushing the flexible sleeve 4 . The flexibility of the distal end region 5 of flexible sleeve 4 which is larger than the flexibility of the fiber or instrument 1 avoids damages of the wall 8 . Furthermore, damages are avoided due to the fact that the outer diameter of the flexible sleeve 4 better approximates the inner diameter of working channel 2 than the outer diameter of instrument 1 . Additionally, the material of the flexible sleeve 4 might be chosen such that the friction coefficient between the flexible sleeve 4 and the limiting wall 8 is decreased. On the other hand damages of the wall 8 might be avoided by providing a front edge 9 of the flexible sleeve 4 with a curved contour which is not possible for most instruments or fibers or might only be manufactured at increased costs. [0034] FIG. 3 shows an instrument 1 which is completely introduced into the working channel 2 wherein the proximal end region 3 protrudes from the proximal end region 10 of the working channel 2 . The proximal end region 3 contacts a renal calculus 11 . In case of instrument 1 being a fiber for light emitted by a laser, the renal calculus 11 might be fragmented by a pulse of the laser which is transferred and delivered by the fiber. The protective cover 4 is pulled back relative to the instrument 1 . Such pulling back might be done by the physician by manually pulling the proximal end region 6 . However, it is also possible to use an automated device for such causing such movement. The protective sleeve 4 is pulled back relative to the instrument 1 as far as necessary for freeing the distal end 3 such that the distal end 3 is located outside the flexible sleeve 4 . The distance the flexible sleeve 4 is pulled back might depend on the design and function of instrument 1 . Asides from the configuration shown in FIG. 3 , it might be possible that the two distal end regions 3 and 5 are located in a common plane. It is also possible that the distal end region 3 of instrument 1 is located slightly inside the flexible sleeve 4 adjacent to the distal tip of the flexible sleeve 4 . The step of pulling back the flexible sleeve 4 is performed after having completely inserted instrument 1 into working channel 2 . In such state instrument 1 extends from the proximal end region to the distal end region of the flexible sleeve 4 . The extension of the flexible sleeve 4 in axial direction is longer than that of the working channel 2 . Such relation of the lengths guarantees that the proximal end region 6 of flexible sleeve 4 protrudes from the proximal end region of the working channel 2 after completion of the insertion of instrument 1 . [0035] FIG. 4 shows a similar arrangement than that of FIG. 3 . However, according to FIG. 4 , flexible sleeve 4 is completely removed and pulled back from the working channel so that only instrument 1 is located inside the working channel. For such embodiment the length of instrument 1 doubles or is larger than the double of the length of the flexible sleeve 4 . The flexible sleeve 4 might have a length of approximately 70 cm. One typical fiber building an instrument 1 might have a length of approximately 3 m. [0036] According to one embodiment of the invention, the working channel 2 is a working channel of a flexible ureterorenoscope of the company KARL STORZ sold under the trademark Flex-X. The working channel 2 of the endoscope preferably comprises an inner diameter of approximately 1.1 mm. In such case the instrument 1 might be embodied in a glass fiber for transmitting energy emitted by a laser. Such glass fiber is sold by the applicant under the trademark FlexiFib and comprises an outer diameter of 0.43 mm. The flexible sleeve might be made of PTFE and might have an inner diameter of approximately 0.7 mm and an outer diameter of approximately 0.9 mm. Accordingly, the flexible sleeve 4 might comprises a wall thickness of 0.1 mm. The proximal end region of the flexible sleeve is linked with a Touhy Borst adapter which is sized such that it might be reversibly crimped against the outer diameter of the glass fiber without damaging the glass fiber. The glass fiber is introduced into the flexible sleeve until the glass fiber protrudes approximately 3 to 5 mm from the distal end region 3 . In such arrangement the Touhy Borst adapter is crimped with the glass fiber. With such fixation the flexible sleeve with the glass fiber embedded therein might be introduced into the working channel 2 of the ureterorenoscope without damaging the limiting wall of working channel 2 by the glass fiber also in cases where the ureterorenoscope is extremely curved. When the distal end region 3 of the glass fiber has passed through the distal end region 10 of the working channel 2 , the Touhy Borst adapter is released and the flexible sleeve 4 is removed and pulled out of the working channel 2 . The position of the glass fiber relative to the endoscope is fixed when removing the flexible sleeve 4 . According to another embodiment of the invention, the flexible sleeve might have a length of approximately 1 m. [0037] The outer diameter of the flexible sleeve might be 0.9 mm which is appropriate for 3.6 Fr working channels. The clearance might be 0.6 mm for commonly used laser fibers. [0038] FIG. 5 shows a curved region of a working channel 2 with a flexible sleeve 4 with an embedded instrument 1 located therein. According to the embodiment shown in FIG. 5 , the distal end 5 is slanted or cut with an angle which differs from a direction perpendicular to the longitudinal axis of the flexible sleeve 4 . The distal end region 5 might be cut in a straight or curved plane. The end region 5 might have a front face 12 with an elliptical outer and inner geometry. [0039] The sloped design of the distal end region 3 has two effects shown in FIG. 5 and FIG. 6 : [0040] According to FIG. 5 , the sloped end region 3 might result in a front face 12 which anticipates the curvature of the working channel 2 such that the front face contacts the working channel at a small angle and maybe with an increased contact surface. [0041] According to FIG. 6 , for a different orientation of the flexible sleeve it might be helpful that due to the sloped distal end region 5 of the flexible sleeve 4 the cross-section of the distal end region decreases continuously to 0 in the direction of the distal tip 13 of the flexible sleeve 4 . This means that the distal tip of the end region might be easily deflected such that the distal end region 5 easily assimilates to the curvature of the working channel 2 . The elasticity of the flexible sleeve 4 might additionally be reduced by providing at least the distal end region 5 with bores, slots and the like. The distal end region 3 of the instrument 1 is preferably located with a small distance from the slanted end region 5 where the full cross section is available in order to provide fill coverage of any edges of the end region 3 . [0042] FIGS. 1, 2 , 5 and 6 show the endoscope in a first operational state whereas FIG. 4 shows the endoscope in a second operational state and FIG. 3 shows the endoscope in a third operational state. [0043] Many variations and modifications may be made to the preferred embodiments of the invention without departing substantially from the spirit and principles of the invention. All such modifications and variations are intended to be included herein within the scope of the present invention, as defined by the following claims.

1a

BACKGROUND OF THE INVENTION A. Field of the Invention The present invention relates to methods and apparatus for thermal regulation of artificially infused intravenous fluids. B. The Prior Art In surgery and after extreme trauma, patients receive intravenous fluids at high rates. Flow rates typically range between 40 and 2000 milliliters per hour and sometimes more. Typically, the fluid temperature upon entering the body is 20 degrees centigrade or cooler. Prior to infusion or transfusion the solutions are refrigerated to prevent incubation of harmful organisms in the fluid media. Upon infusion into the body, the intravenous fluid temperature increases to body temperature (37 degrees centigrade). The heat energy required for this essential temperature increase is supplied by an increased metabolic rate in the patient. This thermal load is not trivial when compared to normal metabolic processes in humans. As a baseline, 2000 food calories are consumed daily. This corresponds to a constant power consumption of 96.6 watts. Intravenous fluid, at twenty degrees centigrade, being infused at a rate of 2000 cubic centimeters per hour is equivalent to a thermal power load of 39.5 watts. Thermal loading in this case is 41% of the baseline power consumption at 2000 food calories per day. Clearly, infusion induced thermal loading can be a principal contributor to the onset of thermal shock and possibly patient mortality. Additionally, such thermal loading may mask the onset of infection during early postoperative care. Presently there is no temperature control device in general widespread use in hospitals and trauma centers. For purposes of this application the terms "intravenous fluid(s)" "IV solution" or "IV fluid" will be used interchangeably and will be used to generically refer to bodily fluids that may be infused or transfused into the body. Blood or blood components are the most typical form of such intravenous ("IV") fluid, however, the term should also be understood to refer to the multitude of artificial solutions or additives that are injected, infused or transfused into the arterial or venous system of patients during medical treatment. An obvious method for heating an IV fluid is by placing the standard intravenous fluid bag into a warmer where the fluid would reach body temperatures and remain there with a high degree of stability. This method would be ideal if the intravenous fluid were not an ideal incubation media. However, such a preheating method would promote the growth of bacteria, fungi and other temperature sensitive organisms and is medically unacceptable. Another method would be to employ a counterflow heat exchanger working on the principle of logarithmic mean temperature difference. This method would require a separate working fluid reservoir to be heated, a fluid pump, and a long heat exchanger. The method is not suitable for the rapid feedback required in a trauma center. Temperature control and flexibility are limited by the size of the working fluid reservoir. At best, the fluid reservoir size would equal the intravenous flow tube size. Even at this stage, a counterflow device is over complicated and poorly suited to the specified task. Additionally, this method does not satisfy the requirement of compactness and simplicity. The intravenous tubing could be run through a large waffle iron geometry heat exchanger. Such a device would work in the steady state flow mode with little feedback involved. However, rapid changes in flow rate and the need for precise control in the variable flow regime rule out this method. The waffle iron geometry would also be too large and time consuming in practice. The ideal heat exchanger must strongly couple the electrical input power directly to the intravenous fluid. In designing the apparatus and method to effectively and efficiently regulate the temperature of IV fluids as they enter the human body certain engineering design parameters were developed and maintained. The device must not store a large amount of heat energy so that the feedback controls can rapidly adjust to variable fluid flow. Additionally, the heat exchanger had to be small and lightweight. Feedback sensors must monitor the flow rate, the initial fluid temperature, and the final intravenous fluid temperature before it enters the body. Any system must be able to detect a sudden flow shutoff. This prevents overheat in active feedback control systems and "tube" incubation in passive systems. Prior art patents that have unsuccessfully addressed the identical problem include U.S. Pat. No. 1,794,215; U.S. Pat. No. 2,124,293; U.S. Pat. No. 4,038,519; and U.S. Pat. No. 4,384,578. Specifically, in U.S. Pat. No. 1,794,215 to Titus a device for the intravenous injection of medicated solutions is disclosed. The device includes a heating device made of glass and shaped to provide a conduit through which the medicated solution flows. A heating element formed of materials such as copper wire is wound around the wall of the conduit. Surrounding the outer wall and in spaced relation thereto is an outer wall adapted to enclose the heating device throughout the major portion of its length. U.S. Pat. No. 2,124,293 to Goldstein discloses an infusion apparatus for injecting fluids into the human body and more specifically a heating device therefor. The heating apparatus of Goldstein consists of an inner tube and a separate outer tube. The outer tube comprises a supporting tube of suitable material such as rubber, upon which a heating coil wound in the form of a helix is found. The heating coil is covered by a layer of heat insulated material such as asbestos which may in turn be covered by a rubber casing. U.S. Pat. No. 4,038,519 to Foucras discloses a flexible heating tube for medical use. The heating tube includes a flexible pipe of transparent plastic material which is provided with at least one electrical helical resistance heating conductor and at least one helical filiform temperature measuring resistance probe. The two elements are wound on the same axis and are embedded in the wall of the flexible pipe and are surrounded in relationship to the bore of the pipe. Finally, U.S. Pat. No. 4,384,578 to Winkler discloses a biomedical flow sensor which includes a resistor type heater on the upstream side of a metal contact shell used to heat a solution. Other patents identified as being of general interest include: ______________________________________3,374,066 to Farrant 4,525,163 to Slavik et al.3,768,977 to Brumfield et al. 4,532,414 to Shah et al.4,065,264 to Lewin 4,576,182 to Normann4,073,622 to Luppi 4,585,056 to Oscarsson4,138,464 to Lewin 4,612,170 to Luther et al.4,160,801 to Badolato et al. 4,622,140 to Lee et al.4,177,816 to Torgeson 4,623,333 to Fried4,231,425 to Engstrom 4,648,865 to Aigrer4,451,562 to Elgas et al. 4,705,505 to Fried4,464,563 to Jewett______________________________________ As mentioned hereinabove, the apparatus and method of this invention have application in any medical or biomedical applications wherein an IV fluid is to be injected, transfused or otherwise artificially placed in the human body. Typical clinical situations in which the fluid heating apparatus of this invention will have specific utility are: trauma patients, patients in septic shock, patients with localized injuries, medical procedures wherein maintenance of basic metabolic rates are critical, and health care of compromised patients. In medical trauma the patient typically has a massive loss of blood, plasma and other body fluids. The patient is typically in shock and the patient's body temperature is typically already depressed. The shock is secondary to fluid volume depletion. It is important that any transfused fluids be incorporated into the body at body temperature to avoid a secondary shock caused by the temperature adjustment required by the body. An example of septic shock is when a patient has peritonitis resulting from a ruptured internal organ. Typically an infection sets in and the body fluids "third space" meaning that the blood volume drops as plasma fluids swell the walls of the intestines and other abdominal organs. It is not uncommon that three to six liters of blood plasma can be lost. In replenishing the lost body fluids temperature maintenance of the fluids entering the body at close to normal body temperature is critical. Requiring metabolic adjustment of the internal body fluids may deepen trauma or cause other physiologically undesirable events to occur. Localized injury is another example where plasma fluids swell the damaged area of the body. The fluid loss can be as much as 1.5 liters for a broken hip in the elderly or related types of injury. Lesser amounts are encountered with other injuries. The temperature sensitive replacement of body fluids in these trauma situations is critical. It is important in many medical operational procedures to maintain the basic metabolic rate. A caloric food consumption of 2,000 food calories per day represents an average power consumption of 96.5 watts. In compromised patients body temperature can drop to 35.5°-34° C. or lower. If IV fluids are infused at 36° to 37° C. the body does not have to expend energy to warm the fluids. Energy can be used to fight infection or implement the restorative processes. Additionally, the infusion of cold fluids may actually cool patients. This effect could mask a temperature rise during the onset of severe infection and therefore delay critical treatment or medication. Finally, the method and apparatus of this invention have shown utility in the treatment of compromised patients. Compromised patients are those patients described as the elderly, those with other diseases and metabolic problems, and immune compromised individuals such as aids patients, chemotherapy patients or radiation therapy patients; and finally, compromised patients include those with malignant diseases. The use of thermally sensitive materials and the transfusion of thermally sensitive materials is made possible through the use of the apparatus and method of this invention. The medical benefits vary from convenient to critical. SUMMARY OF THE INVENTION The apparatus or device embodying this invention incorporates four basic subassemblies into an integrated, functionally effective IV fluid temperature regulating device. The four subassemblies are an intravenous infusion assembly; a heat exchange assembly; a controller subassembly; and an energy source subassembly. The first subassembly, the intravenous infusion assembly, may take any of a variety of well-known "sets". The most typical form of an intravenous infusion assembly involves a container or reservoir for fluid, flexible tubing connecting the fluid reservoir to the point of entry into the human; and a device such as a syringe for injecting the fluid into the human. Other well-known infusion assemblies can likewise be used. Examples of such assemblies would include "sets" of tubing, valves and other types of flow regulating devices that can be assembled to intravenously inject or pump one or more fluids or medications into the human body. A number of well known devices are used to move the IV fluid along its intended path into the body. The devices range in sophistication from conventional gravity-feed devices to the complex IV infusion pumps that are now common in therapeutic settings. Also used are drop counting apparati that do not place a positive mechanical pressure on the fluid being fed intravenously. The particular assembly of components of the intravenous infusion assembly is not limited in this invention. The only requirement is that a sufficient length of tubing be provided prior to entry of the fluid into the human body so that the temperature of the I.V. fluid can be regulated and/or monitored with the heat exchange assembly of this invention. The second subassembly, the heat exchange assembly of this invention is mounted to or in the flexible tubing portion of the infusion assembly. The heating apparatus of this invention is adaptable for use with any of the known IV feed devices. The heat exchange assembly includes one or more heat exchangers; one or more fluid temperature sensors; one or more fluid flow sensors and a control signal wire bundle. The heat exchanger, which typically includes one or more twisted wire components, is extruded or embedded in the walls of the flexible tubing. The particular method or technique for achieving the embedding is a matter of choice to a person of ordinary skill in the art and may include an actual embedding of wire strands or the like into the plastic walls of flexible tubing followed by wrapping with a non-conductive material, i.e., shrink wrap. Other techniques may also be used. The heat exchange assembly is mounted in a length of flexible tubing all of which is disposable. Standard electrical connectors are provided to connect the disposable heat exchanger (embedded in a section of flexible tubing) to the control signal wire bundle and ultimately to the controller subassembly. The heat exchanger assembly and various fluid flow and temperature sensors are connected to the controller subassembly through the control signal wire bundle. The use of the control signal wire bundle enables the device of applicant's invention to be disposable and interchangeable with various intravenous infusion assemblies. The control signal wire bundle with the heat exchanger placed close to the human body enables temperature regulation immediately prior to an IV fluid entering the human body. Such placement minimizes a cooling or temperature gradient from existing between the heating apparatus and the body. The advantages of such temperature control have been detailed hereinbefore. The third subassembly of this invention is a controller subassembly. The controller subassembly includes a microprocessor based unit for logic control, and related input and output control boards. The controller subassembly is functionally attached to the intravenous infusion assembly and to the heat exchange assembly such that the controller subassembly monitors and changes the temperature and mass flow characteristics of the IV fluid being pumped or gravimetrically flowing into the human body. In alternate embodiments of the invention the control signal wire bundle may be removably connected to the controller or removably connected to both the controller and one or more heat exchangers. The fourth subassembly of this invention is the energy source. The energy source may be one or more electronic digitally programmable direct current power supplies. The energy source may also be either AC current, or simply battery power. Note that this invention has utility with any of the well-known human bodily fluid injection devices. Typical of such applications are blood transfusions, kidney dialysis, and any other biomedical treatment that involve removal of fluid from the body, treatment of the fluid and return of the fluid or the injection of an artificial or substitute fluid into the body. BRIEF DESCRIPTION OF THE DRAWINGS Further details of the present invention are explained with the help of the attached drawings in which: FIG. 1A shows the four subassemblies that comprise the apparatus of this invention; FIG. 1B is a schematic showing the four subassemblies with more detail of the heat exchanger subassembly and infusion subassembly; FIG. 2 shows one embodiment of the flow sensor of FIG. 1; FIG. 3 shows a cut away view of wiring and insulating wrap for a heat exchanger; FIG. 4 shows a cross sectional view of the heat exchange assembly of FIG. 3; FIG. 5 shows an alternate embodiment of the flow senser used in the present invention; FIG. 6 is a schematic representation of the control logic circuitry of the controller; and FIGS. 7-10 are flow charts showing the program operation steps performed in the controller subassembly microcomputer. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1A shows the four subassemblies that comprise the apparatus of this invention. The four subassemblies are: an intravenous infusion assembly 30; a heat exchanger assembly 40; a controller subassembly 20; and an energy source subassembly 15. Temperature control is performed by the heat exchanger subassembly 40 containing heat exchanger 41 which provides heat to IV tube 32, a component of the infusion subassembly 30. Flow sensors 22 and temperature sensors 21 and 23, also components of the heat exchanger subassembly 40, accurately measure IV fluid temperature and flow rate. The control and signal wire bundle 42 of the heat exchanger subassembly 40 carries signals from the flow sensors and to the heat exchanger from controller subassembly 20. Controller subassembly 20 contains a CPU 92 which sends and receives the signals through I/O control boards 90. The controller subassembly is independently powered and it controls the power supplies of energy source subassembly 15. Referring to FIG. 1B, more detail can be seen of the first subassembly, the infusion subassembly 30. The infusion subassembly 30, includes an IV bag 31, a clear flexible IV tube 32, and a hypodermic needle 33. The level of IV fluid 34 found in IV bag 31 is demonstrated numerically by the number 35. The components of the infusion subassembly 30 are all interconnected in standard medical hardware and connectors. Also shown in more detail in FIG. 1B, the second subassembly, the heat exchange assembly 40, first contains the control signal wire bundle 42 running parallel to the IV tube 32 of the infusion assembly 30. One or more heat exchangers 41 are incorporated into the control signal wire bundle 42. These heat exchangers 41 are usually electrical resistors which are connected to control signal wires 42. A flow sensor 22 is also incorporated into the control signal wire bundle. Also included are initial 21 and final 23 temperature sensors. Both the temperature sensors 21 and 23 and the flow sensors 22 are connected to the control signal wire bundle 42. The control signal wire bundle 42 can be extended to encompass the wire harness 51 which connects to the controller subassembly 20, or the control signal wire bundle 42 can be removably connected to the wire harness 51 in close proximity to the intravenous infusion assembly 30. Referring to FIG. 3 and cross sectional view in FIG. 4, the heater elements making up the heat exchanger can be either a multi-stranded heater wire 48 and/or an electrically conducting external skin 46 (For example a conducting plastic). Additionally these heater elements are located between the IV tube 32 and an electrically and/or thermally insulating outer skin 47. Returning to FIG. 1B, the third subassembly, the controller subassembly 20, is equipped with two or more temperature monitoring channels, at least one flow monitoring channel, and at least one power output for the heat exchanger. The controller subassembly monitors the flow sensor 22. Referring to FIG. 2, the flow sensor 22 of FIG. 1B is a mass flow sensor which uses a flow sensor heater 43, and two temperature sensors: an upstream sensor 27, and a down stream temperature sensor 26. The sensors making up flow sensor 22 are monitored by the controller subassembly through the control signal wire bundle 42. There is an extension of the flow sensor heater 43, called a heater tail 44, which is in close proximity to the downstream temperature sensor 26. During steady state flow the IV fluid flow is roughly proportional to the inverse of the temperature difference across the flow sensor heater 43. The electrical power supplied to the flow sensor heater 43 is modulated in the time domain so that the temperature difference across the flow heater is modulated in the time domain so long as the IV fluid flows through the IV tube 32. When the fluid flow stops the heater tail 44 warms the downstream temperature sensor 26. The warming affect of the heater tail erases the temperature modulation signal and signals the no flow condition. Electrical heater leads 45 are interconnected to the control signal wire bundle 42. Referring now to FIGS. 1B and 2, the primary component of the controller subassembly 20 is a microprocessor which is discussed later. One temperature input of the microprocessor monitors the final fluid temperature sensor 23. Two temperature sensor inputs and one power output constitute the mass flow sensor 22. The power to the flow sensor heater 43 is modulated in the time domain. The other power output is connected to the heat exchanger 41. The flow sensor 22 provides precise initial fluid temperature information and a signal which is proportional to the fluid flow. In practice, the flow rate signal is not exact because specific heat differs betweent he various intravenous fluids in use (blood plasma, saline, Ringers solution, various glucose solutions, Dudricts solution 1-2-3, other hyper-alimentation solutions, and many others) and the effect of the external environment, i.e., air temperature and air currents over the exchanger. The fourth subassembly of this invention is the energy source subassembly 15. The energy source subassembly may be one or more electronic digitally programmable direct current power supplies. The energy source subassembly may also be either AC current, or simply battery power. Individual Components and Operation Descriptions Individual components and precise operation of the components of the invention are described in more detail in sections which follow. Heat Exchanger The intravenous fluid heat exchanger 41 has two near optimal intravenous fluid heat exchanger geometries: a parallel wire heat exchanger and a coaxial heat exchanger. In either geometry, the power dissipated per linear cm should be no more than 2 watts. Depending upon the application, the length of a parallel wire heat exchanger length can be between 10 and 200 centimeters. The length depends upon the particular design for maximum intravenous fluid flow. Referring to FIG. 3, FIG. 4 and FIG. 1B, the heat exchanger fabrication can be described as follows. The primary heat exchanger design is a parallel wire type. A clear intravenous tube 32, 1-4 mm diameter, is centered between two nichrome heater wires 48. The entire structure is encased in an insulating cylindrical sheath of 0.1-1 mm in thickness. The nichrome heater wires 48 are stranded to ensure flexibility of the heat exchanger 41. They are also bonded with an insulating glue to hold the wires together. Measurements of this geometry with flow rates of 2400 milliliters per hour and an output temperature of 36 degrees centigrade indicate that about 75% of the input electrical power is transferred to the intravenous fluid 34. The heat exchanger 41 has a low mass for a minimum stored heat energy in the exchanger. All energy source subassembly 15 components are outside of the intravenous fluid volume for safety. The proper choice of materials allows the heat exchanger to be extremely flexible; the device can be bent 180 degrees in angle about a 3 centimeter radius during operation. There are a variety of different fabrication methods for this exchanger type. A simple electrical winding pattern where the heater wire is composed of stranded wires 48. Series and parallel electrical winding configurations are used where the stranded heater wires 48 are twisted pairs to reduce AC noise coupling to heart rate monitors, and the like. The stranded heater wires 48 are connected at the end by an electrical jumper (not shown in drawing) to complete the simple winding pattern circuit. A more typical geometry is the coaxial structure. A fine twisted pair heater wire insulated within a thin tube 0.1-1 mm in diameter and strung through the center of a standard intravenous tube 2-4 mm in inside diameter is used. This geometry is optimal in terms of thermal coupling efficiency and a low heat exchanger mass. Additionally, the coaxial heat exchanger is easily modeled since all heat energy is deposited into the intravenous fluid before radiating into the surrounding air. A clear insulating jacket (not shown in drawing) may be placed around the IV tube 32 to keep the IV fluid 34 warm between the heat exchanger and the patient. Temperature Sensors A mass flow sensor such as sensor 22 shown in FIGS. 1B and 2 requires that both the upperstream T 0 temperature sensor and the downstream T 1 temperature sensor be bathed in IV fluid. Other temperature sensors such as the final temperature sensor 26 can be placed outside the tube wall. The performance requirements for commercial embodiments of temperature sensors are that they must be accurate to ±0.1° C. and stable to ±0.03° C. The sensor must have a response time of 0.5 seconds, and dimensions no larger than 0.5 mm in diameter and 1 mm in length. Accuracy requirements are subject to medical review. Most sensor technologies (RTD, infrared, thermocouple, thermistor, black body radiation) can meet these requirements on a prototype basis. Mass production with this degree of reproducibility is rather easy for thermocouples because their signal is based upon differing Fermi voltages between dissimilar metals. Only the electronics or software need be calibrated. Other sensors may cost more to mass produce while satisfying these constraints. This issue will ultimately be resolved by the manufacturer. Intravenous Fluid Flow Sensor Fluid flow is measured by an electronic mass flow meter such as flow sensor 22 of FIG. 1B and FIG. 2. Along the fluid flow path, in the intravenous tube 32, a small 0-2 watt resistor is located between two thermocouple temperature sensors 26 and 27. The temperature difference between the two sensors is measured by a voltage comparison in the controller 20. This signal is inversely proportional to the mass flow and therefore the fluid flow rate. The geometry of the flow sensor heater resistor is most important. In reality, the heater is two resistors, a primary heater resister R 1 , like flow sensor heater 43, and a secondary heater tail resistor R 2 , like heater tail 44. 80-95% of the power is radiated in R 1 . The secondary resistor is located within close proximity to the downstream temperature sensor T 1 like downstream temperature sensor 26. Spatially, the primary resistor is located a distance d (3-10 mm) upstream of the temperature sensor T 1 . The sensor is located this far downstream to ensure that the fluid is sufficiently "mixed" to ensure a nearly linear temperature signal to flow relation over a flow range of 0-40 ml/min. The secondary heater tail resistor R 2 is used to sense flow cutoff. R 1 and R 2 are in series. The voltage modulation with the "heater-heater tail" geometry is to generate a different signal profile for the steady flow and no flow cases. During steady flow, and with nearly adiabatic flow changes, the T 1 temperature signal will oscillate slightly forming a temperature pulse train signal having a frequency nearly identical to the modulation frequency of the flow heater voltage. For mass flow sensors designed in this manner, the flow rate is proportional to the temperature difference over the average power. The flow signal fluctuates by about 5% about the mean value. The magnitude of the signal does not oscillate more about the mean because the flow sensors heat capacity has an averaging effect. The pulse train signal will continue so long as there is flow. When flow stops, R 2 the heater tail, which is in close proximity to the downstream temperature sensor T 1 , warms the T 1 sensor and removes the modulated pulse train signal. The no flow signal condition can be resolved within two periods of flow sensor modulation, this corresponds to 1-3 seconds. The response and accuracy of this type sensor can be enhanced by further miniaturization. The important components of flow sensor 22 are: The primary flow heater 43, which is a nichrome wire coil wrapped around the IV tube 32. The heater tail 44, which is an extension of the nichrome wire that runs along the outside of the tube and parallel to the axis to the tube. The distance of the downstream temperature sensor 26 T 1 to the flow heater coil 43 should be between 3 and 9 mm. Additionally, the temperature sensor 26 T 1 is within proximity of the heater tail 44, but it is located on the opposite side of the tube to avoid direct conductive wall heating of the T 1 sensor during the steady flow condition. The heat shrink tubing surrounding the temperature sensor T 1 acts like a spring to hold the sensor on the other side of the tube wall. For the mass flow sensor, it is extremely important that both temperature sensors are in intimate contact with the IV fluid. Two temperature sensors are required to avoid any introduction of an integrated error as the initial temperature of the IV fluid, T 1 , may change with time. The heater-tail geometry can also be manufactured using a variable conductor density heater tape that can be applied to the outside of the IV tubing. FIG. 5 shows an alternate configuration for the mass flow sensor. The initial T 0 temperature sensor 62 is inserted in a hole through a standard IV drop counting glass 64. IV fluid 65 is shown dropping into the IV drop counting glass 64. The hole for the T 0 temperature sensor 62 is sealed by a clear PVC-CPVC cement seal 66. Thermocouple signal wire 68 carries a signal from T 0 temperature sensor 62 to the controller subassembly via the control signal wire bundle (not shown). IV drop counting glass 64 is connected to a clear 5/16 PVC tube (thermal mixing chamber 70) where the electrically isolated flow heater resistor 72 is located. The electrically isolated flow heater resister 72 is electrically connected in series with a second resistor, the heater tail resistor 78, via a flow sensor heater lead 76. The heater tail resistor 78 is attached to the outside of the IV tube 32 by a Kapton tape heater tail clamp 82. The thermal mixing chamber 70 is connected to standard IV tubing 32 via a clear heat shrink transition 74. A downstream T 1 temperature sensor 63 is located inside the IV tube 32 and in close proximity to the heater tail resistor 78. The downstream T 1 temperature sensor signal wires 84 and the flow sensor heater leads 76 are attached along with thermocouple signal wires 68 as a group to the control signal wire bundle (not shown). Other possible fluid flow sensing methods are high frequency flow meters, magnetic flow sensors, simple rotary flow sensors, pressure difference sensors, and drop counters. The controller can also function using flow feedback signals from a flow control device. A detailed analysis of cost and applicability must be done before these other flow measurement techniques can be considered for adoption. An additional analysis of its cost in comparison to the mass flow rate method must also be done. For the time being, electronic mass flow rate meters work and are simpler in terms of fabrication and principle of operation. This does not mean that these other measurement techniques should be excluded from any design. Control Signal Wire Bundle The control signal wire bundle is connected through standard electrical connectors to the disposable heat exchanger. The control signal wire bundle is connected at the other end to the controller subassembly. The control signal wire bundle may be electrically conductive cable strands, or optical fibers. The control signal wire bundle carries signals from the heat exchanger assembly and various fluid flow and temperature sensors to the controller subassembly. The use of the control signal wire bundle enables applicant's invention to be disposable and interchangeable with various intravenous infusion assemblies. Operation Process Referring to FIG. 1B, the process of operation of the invention can be described as follows. The IV tubing 32 is filled with fluid 34 and purged of air; then flow is established. The control wire harness 51 is plugged into the controller 20. The controller 20 is then switched on. A flow signal is recorded by the controller 20 and the appropriate amount of electrical power 15 is metered to the heat exchanger 41 using the relation: ##EQU1## Where T set is the set point temperature (say 36° C.), T 0 is the initial fluid temperature in °C., C s is the heat capacity of the IV solution (say 4.18 joules /ml°C.), F is the IV fluid flow in (ml/sec), ε is the working efficiency of the heat exchanger, T 2 is the time derivative of the final temperature T 2 , and α is an empirical damping coefficient. The electrical power sent to the heat exchanger is updated cyclically within a logical control loop. Each time the microprocessor 20 cycles through this loop, the flow is updated and the working efficiency is recursively calculated based upon a flow weighted bisection method. The recursive efficiency is given by ##EQU2## ε n is the updated efficiency. ε n-1 is the old efficiency. P n-1 is the applied power during the last loop cycle. w is a weighting factor related to the cycle frequency of the microprocessor. P out is the amount of electrical power that actually heats the fluid. P out is given by P.sub.out =(T.sub.2 -T.sub.0)C.sub.s F. The initial working efficiency of the exchanger is chosen between 20% and 90% depending linearly upon the flow signal. The physical efficiency is between 20% and 75%. Efficiency is proportional to the power applied to the heat exchanger. (The wires get hotter.) This control loop is repeated until one of the following conditions occur: 1.) Flow stops. 2.) The magnitude of the time derivative of the flow exceeds a specified value. 3.) The final temperature of the fluid, T 2 , is greater than an assigned value (39° C.). 4.) There is an error signal indicating that one or more of the control signal lines is not working. 5.) A periodic reset occurs after the controller runs for a moment of time (1 hr.). Error conditions (1-4) cause the controller 20 to shut down. Condition (5) results in the device shutting down for 1-5 min. After which time the controller starts anew. Summary of the Controller Block Diagram FIG. 6 is a block diagram for the controller used in the present invention. In addition to the controller components, FIG. 6 for reference also shows the heat exchanger resistor R H , flow heater resistor R F , thermocouple contacts T 0 , T 1 , T 2 , the IV tube 32, IV bag 31, and AC and DC power supplies. The controller unit is based upon the Basicon MC-li microcontroller 102. Basicon, Inc. is a company located in Portland, Ore. The controller's CPU is an Intel 8052 microprocessor configured to have a memory of a 16 kilobytes, an 8 kilobyte eprom, and six I/O ports from two Intel 8255 programmable peripheral interface chips. This configuration is stock and was purchased from Basicon. The multiplexed 12 bit A/D board 104 was also purchased from this company. Three thermocouple signal processors 106, 108, and 110 are used to amplify and linearize the voltage signals from the thermocouple sensors received at points T 0 , T 1 and T 2 . These are stock items purchased from OMEGA Corporation in Massachusetts, (Model TAC-386-JF). The "Power to R F and AC Power Relay Board" 111 is a unique construction. This board has three functions: 1.) An output line is connected to a solid state relay 112 which controls AC power 113 to a 12 volt power supply 115 and 48 volt power supply 116. If an error condition occurs in the microprocessor the electrical power to the IV device can be cut off at the source. The relay is turned off when the controller is switched on. 2.) The board also contains a switching buffer for the modulated flow sensor heater signal coming from the microcontroller. 3.) The voltage signal across a shunt resistor (0.5-2 ohm) which is in series with the flow heater resistor R F 118 is connected to one of the 12 bit A/D board channels to monitor the flow heater circuit. All components on this board, the solid state relay and AC and DC power supplies are made from available parts. The "8 bit D/A, 0-48 VDC output board" 120 is also unique construction. It has an 8 bit microprocessor interface to a D/A chip. The board has two functions: 1.) The DAC chip's voltage output is amplified using a power transistor follower circuit to control the current in the heat exchanger resistor R H 122. 2.) The voltage signal across a shunt resistor (0.5-2 ohm) which is in series with the heat exchanger resistor R H 122 is also sent to the 12 bit A/D board for circuit status checking by the microcontroller. Components on this board are commercially available parts. Note again that shunt resistor voltage signals can be used to measure the resistance of R F and R H . The specific values of either shunt resistance is programmed into software so that one controller can identify and work with many different disposable heat exchanger configurations. Controller Operation Flow Chart FIG. 7 shows the initial steps performed by the controller software. Upon turn on the microprocessor in step 1 (S1) within the controller subassembly, the microprocessor begins executing a program which is stored on an eprom chip on the CPU board. The program then configures the input output memory address locations in step 4 (S4) and sends a series of startup instructions to the LCD screen driver hardware in S5. In S6 software error trapping flags are then set so that the CPU executes a shutoff in the event of software failure. The 8052 microprocessor is equipped with an internal watchdog timer also set in S6. An internal watchdog timer, which is also set in S6, is a subprogram that is executed simultaneously with the main program and is called at subroutine flags A or B. FIG. 9 shows the steps of execution of the auxiliary watchdog timer. The watchdog monitors the clock in S202 and checks to see if the clock time has exceeded the value of a time set variable set by the main program. If the clock time exceeds the time set value in S204 the watchdog process interrupts the main program and a specified device shutoff is executed by the microprocessor in S208. If the program is running properly the time set variable is updated periodically. External watchdog timers are also installed to provide another level of error protection. Returning to FIG. 7, the program then checks the circuit integrity of the 12 and 48 volt power supplies within the energy source subassembly in S8. This is accomplished by measuring the voltage across shunt resistors in series with each power supply. These voltage signals are digitized using the 12 bit analog to digital converter. If either power supply circuit fails, as indicated by S10, the program then executes a controlled shutdown in S12. Power is cut off from the energy source subassembly 20 by opening the solid state relay. Then an error message is sent to the LCD screen in S14. Program execution is then terminated in step 16 (S16). If the power supplies are working properly the internal clock is reset and started again in S18 which calls a subroutine at flag A. A startup message is then sent to the LCD screen in S20. The program then begins the main control loop in S22. At the beginning of the control loop in S24 diagnostic data is sent to the RS-232 serial data port where an external interactive terminal device can be optionally connected. The time set variable for the watchdog timer is then updated and called at subroutine flag B. This is the only point in the loop where the time set variable is reset. Next in S26 the temperature signals T 0 , T 1 , and T 2 are digitized using the 12 bit analog to digital (A/D) converter. The T 0 , T 1 , and T 2 temperatures correspond to the following respective locations: the initial temperature sensor 21, the downstream temperature sensor 26, which is within the flow sensor 22, and the final temperature sensor 23. If any temperature sensor fails to properly function, as determined in S28, the program in S29 opens the solid state relay, sends an error message to the LCD in S32, and terminates execution in S34. If time<30 seconds in S36 the T 0 , T 1 , and T 2 values are stored in separate data registers (say T00, T10, and T20) which represent the initial temperatures of the IV fluid solution. These temperature values are used to compensate for any thermocouple amplifier signal drift in the calculation of flow. If time<30 seconds, as determined in S38, the main control loop ends here and the program returns to the beginning of the main control loop. Otherwise the control loop continues. After 30 seconds the electrical power to the flow sensor heater R F is modulated by toggling the power cycle to cycle in S40. The pattern is that the power is on one loop cycle and off the next. This is a 50% modulation. Continuing the program in FIG. 8, the flow, flow time derivative, and the modulation are then computed logically from the temperature signals in S42. The modulation of the temperature signal across the flow sensor heater 43 is measured by comparing sign of the time derivative of the temperature T 1 from cycle to cycle. If T 1 changes sign from cycle to cycle the signal modulation is good and nearly steady flow is present. If flow stops or decreases rapidly the heater tail resistor 43, which is in close proximity to the downstream temperature sensor 26 T 1 , warms the T 1 sensor thereby erasing the modulation signal and providing a no flow signature that the microprocessor can recognize. 80 seconds is allowed for the flow sensor to warm up. If the sensor gets too hot during this time (as determined in S44 as the result of no flow) the program executes a shutdown in S46 by opening the solid state relay, sending an error message to the LCD in S48 and terminating execution in S50. If time<110 seconds the main control loop ends and the program returns to the beginning of the main control loop in S52. Otherwise the control loop continues. The power to be applied to the main heat exchanger is logically computed based upon the temperature and flow conditions in S54. The algorithm used is a temperature dampened proportional flow bisection algorithm. The rate of convergence of the working efficiency is changed based upon the flow rate and the temperature difference between then set point temperature and the IV fluid exit temperature T 2 . All these various methods use a bisection technique to determine the working efficiency. If the modulation signal is weak as determined in S56, meaning that the sign of the time derivative of T 1 has not changed from the last cycle, the power to be applied is set to zero in S58. If there is no modulation signal for four cycles, as determined in S60, the program executes a shutdown in S62 by opening the solid state relay, sending an error message to the LCD in S64, and terminating execution in S66 under the assumption that there is no flow present. If the exit temperature of the IV fluid T 2 is too hot (39 degrees centigrade as determined in S68) the program executes a shutdown by opening the solid state relay, sending an error message to the LCD, and terminating execution. If all the tests for temperature, the flow, and circuit integrity are passed the CPU logically assumes that the device is functioning properly and then sends a digital signal to the digitally programmable power supply that adjusts the voltage across the heat exchanger in S70. The combination of the 48 volt direct current power supply and the 8 bit digital to analog output board comprise the digitally programmable DC power supply in the present working example. In S72, The output temperature T 2 , flow and modulation information are written to the LCD screen of S74 as status information. The main control loop ends here. If time<3600 seconds, as determined in S76, the program returns to the beginning of the main control loop. Otherwise a 1 hour reset subroutine of FIG. 10 is executed so that power to the heat exchanger and the flow sensor is cutoff in S78 allowing the flow sensor to cool for one minute in S80. This is done to prevent any integrated drift in the thermocouple signal amplifiers from erroneously affecting the flow calculation. Finally, control is returned to the eprom startup of FIG. 7 after the one minute delay is complete. Although the invention has been described above with particularity, this was merely to teach one of ordinary skill in the art how to make and use the invention. Many modifications will fall within the scope of the invention, as that scope is defined by the following claims.

1a

This application is a continuation of application Ser. No. 07/193,972 filed on May 13, 1988, now abandoned, which is a continuation-in-part of application Ser. No. 06/700,351 filed on Feb. 19, 1985, now abandoned, which is a continuation-in-part of application Ser. No. 06/470,075 filed on Feb. 28, 1983, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to mechanical blood coagulation on endogenous hard body such as bone tissue, for example, employing improved resorbable wax compositions and methods. 2. Discussion of Relate Art This application is a continuation-in-part of application U.S. Ser. No. 06/700,351 filed Feb. 19, 1985, which is, in turn, a continuation-in-part of application U.S. Ser. No. 06/470,075, filed Feb. 28, 1983, now abandoned. Published German Patent application P 32 29 540.5 represents the priority document on which the above identified parent applications are based. For mechanical blood coagulation on endogenous hard body tissues, such as bone, for example, it is customary to treat resected bone parts with bone wax. For the same reason, blocks of bone wax are also used to cover spaces filled with spongiosa. The waxy masses used up to the present time were made, for example, of beeswax, almond oil and salicylic acid, or beeswax and isopropyl palmitate. Relevant literature includes, for example, Douglas, B. L.: Oral Surg., Vol. 6, p.1195, 1953; Selden, H. S.: Oral Surg., Vol. 29, p. 262, 1970; Shields, T. W.: General Thoracic Surgery, Lea and Febiger, Philadelphia, 1972; and Wolter, D. et al.: Chirug., Vol. 46, p. 459, 1975. In general, postoperative healing proceeds without disturbance; bacterial contamination is rare. Commonly, however, in the case of the bone waxes used for coagulation during surgery up to the present time, coverage of the implant by granulation tissue containing abundant macrophages and giant cells is observed, see D. Wolter et al., op eit. The granulation tissue becomes fibrotic within the body with the passage of time. Direct contact between the bone and the wax does not occur. Nonspecific foreign body reactions often take place at the spongiosa/bone wax contact zones. This inhibits the new formation of bone and promotes the development of pseudoarthroses, see Geary, I. R. et al.: Ann. Surg., Vol. 132, p. 1128, 1950 and Howard, C. C. et al.: Clin. Orthop., Vol. 63, p. 226, 1969. High molecular weight polymers and their use in the medical sector are known. They have fiber properties. Their tolerance and degradability have been studied in detail. Well known, for example, are synthetic filament materials, resorbable with the body, based on polyglycolic acid and polylactic acid; see for example, U.S. Pat. Nos. 3,297,033; 3,626,948; 2,668,162; 2,676,945 and 2,703,316. Published German patent application P32 29 540.5 relate to resorbable waxes for mechanical blood coagulation on hard body tissue, more especially on bones, which consist of wax-like polyester oligomers of lower hydroxycarboxylic acids. These materials range from viscous to solid at body temperature. By virtue of their structure, these waxes are degradable by the body's own metabolic processes, the degradation rate being adjustable in known manner. The preferred waxes have average molecular weights of about 200 to 1500 and, more especially, of about 300 to 1000. Corresponding polyester oligomers of lactic acid and/or glycolic acid are described as being particularly suitable. According to the published German patent application cited above, monofunctional and/or difunctional alcohols or carboxylic acids or carboxylic anhydrides and/or primary or secondary monoamines may be used to regulate the average molecular weight of the polyester oligomers. A definitive average molecular weight may be determined in advance in a known manner by selecting suitable mixing ratios of oxycarboxylic acids and additional monofunctional or difunctional component. It is known that the reaction products obtained are not uniform in their degree of oligomerization and still contain certain quantities of the starting components. DESCRIPTION OF THE INVENTION Other than in the operating examples, or where otherwise indicated, all numbers expressing quantities of ingredients or reaction conditions used herein are to be understood as modified in all instances by the term "about". An objective of this invention is to optimize resorbable waxes for the mechanical absorption of blood on hard body tissue of the described type. One aspect of the present invention relates to compositions which, because of their consistency, can assume the tasks previously required of a bone wax, but at the same time, as a result of their chemical structure, avoid the disadvantages of the previous bone waxes. In particular, the wax-like compositions in accordance with the present invention are physiologically safe and readily resorbable, and do not lead to the formation of toxic degradation products. In a specific embodiment of the invention, a controllable degradation of these waxy masses by endogenous degradation reactions takes place, so that nonspecific foreign body reactions and, in particular, chronic inflammations at the tissue/bone wax contact zones is avoided. In addition, as a result of the resorbability of the present compositions in accordance with the invention, uninhibited new formation of bone is promoted. In accordance with the present invention it has been discovered that improved, resorbable, body tissue compatible waxes are produced and isolated from the reaction product of at least one hydroxycarboxylic acid and a trihydroxy alcohol or adduct of said alcohol. The trihydroxy alcohol is employed as a co-reactant to adjust the average molecular weight of the resulting polyester oligomer of a hydroxycarboxylic acid such that waxes are obtained which are viscous to solid at body temperature and which exhibit particularly improved properties. The combination of glycerol with oligoesters of hydroxycarboxyic acids, preferably lactic acid and/or glycolic acid leads to degradable wax-like components of the type mentioned which, on implantation in living body tissue, are distinguished by particularly pronounced compatibility with the body. Accordingly, the present invention relates to resorbable waxes for the mechanical blood coagulation on hard body tissue, more especially bone, of wax-like polyester oligomers of hydroxycarboxylic acids, especially lactic acid and/or glycolic acid which range from viscous to solid at body temperature and which are prepared using a trihydroxy alcohol or adducts thereof to regulate the average molecular weight of the polyester oligomers. The polyester oligomer waxes according to the present invention has incorporated therein at least one co-reactant moiety bound thereto in a terminal position, where the co-reactant is a trihydroxy alcohol or solvent thereof. While glycerol is preferred, and physiologically compatible trihydoxy alcohol or adducts, such as glycerol with 1-6 moles of propylene oxide are employed. The oligomer segments of these preferred wax compositions generally contain the structural unit: ##STR1## wherein R is a straight or branched chain alkyl group, an unsubstituted or alkyl substituted cycloakyl group, or an unsubstituted or alkyl substituted phenyl group, with R preferably having from 1 to 20 carbon atoms, more preferably from 2 to 10 carbon atoms, and most preferably from 2 to 6 carbon atoms; and n is an integer dependent on the selection of the R group, and is preferably chosen so that the mean molecular weight of the polyester-oligomer chain is in the range of from about 200 to about 1500, more preferably about 300 to about 1000. The desired consistency of the wax compositions is attained by careful control of the degree of oligomerization. The above polyester-oligomer chains are obtained through oligomerization of a hydroxycarboxylic acid, or a mixture of hydroxycarboxylic acids, of the formula ##STR2## wherein R has the meaning given above. Hydroxycarboxylic acids for use herein include glycolic acid, the isomeric lactic acids, the possibly isomeric α- or β-hydroxypropionic acids, the possibly isomeric α, β- or γ-hydroxybutyric acids, o-hydroxybenzoic acid (salicylic acid), m-hydroxybenzioc acid and/or p-hydroxybenzoic acid. Specific isomers of the acids mentioned or mixtures of the above acids can be used. When mixtures of two or more hydroxycarboxylic acids are employed, the R group defined above can have more than one structure in the polyester-oligomer chain, depending on the mixture of hydroxycarboxylic acids chosen for its preparation. The oligomer segments of the optimized bones waxes according to this invention are preferably derived from lactic acid and/or glycolic acid. The starting material for the production of the oligomers may be the monomeric hydroxycarboxylic acids corresponding to the above definition. However, the easy-to-handle dimerization products, i.e., the lactide and/or the glycolide, will generally be used. The lactic acid dimer may be used, for example, as L-lactide or even as D,L-lactide. Preferred waxes according to the invention are obtained where 9 to 10 mol of the monomeric glycolic acid or about 12 mol of the monomeric lactic acid are used to 1 mol glycerol. Specific oligomerization reactions are described in the above referenced published German Patent application. In one particularly preferred embodiment of the invention the wax-like material is at least largely freed from its content of unreacted starting components and consists essentially of the polyester oligomer. In particular, the content of unreacted hydroxycarboxylic acids is reduced to residual contents below 0.5% by weight, preferably to residual contents below 0.2% by weight, and most preferably to at or below 0.1% be weight. Studies conducted with these materials have shown that tissue damage can be avoided particularly when it is ensured both through the production process and through subsequent purification of the degradable wax that its content of unreacted carboxyl groups is at least greatly reduced or, preferably, is substantially completely eliminated. Free carboxyl groups such a these may even be present in the reaction mixture in the absence of the molecular-weight-regulating dicarboxylic acids discussed in the above-cited published German patent application. The statistical molecular weight distribution which derives directly from the production of the waxes always leaves behind in the oligomeric reaction mixture a certain number of free carboxyl groups, which are present at least predominantly as free monomeric hydroxycarboxylic acids. The purification of the oligomer reaction product which is initially formed is preferably carried out in accordance with the invention to remove unreacted components or reaction products having an undesirably low molecular weight. Preferably, the initially formed oligomer reaction product is mixed with a water-miscible organic solvent, for example, with a ketone such as acetone, or with an alcohol such as methanol, ethanol or the like; and the resulting suspension is introduced into a solvent which does not dissolve the desired oligomer fractions, but is an effective solvent for the unreacted and low molecular weight components of the oligomer reaction product. For example, isopropanol has been found to be a particularly suitable solvent for this second stage of the process. In one effective purification process according to this invention, the oligomerization reaction product initially formed is mixed with water-miscible solvent containing a ketone such as acetone or monohydric alcohol, such as methanol in a ratio of approximately 1:1 and intensively digested. The solids suspension formed is then introduced into several times, for example, 7 to 12 times, its volume is isopropanol and filtered off. The liquid phase is filtered under suction, washed preferably with isopropanol and then dried. A wax-like product of the desired quality substantially free from carboxyl groups is produced in this way. The polyester oligomer waxes according to the invention are also characterized by an average molecular weight of from about 200 to 1500 and preferably of from about 300 to 1000. The resorbable waxes are paste-like to soft-spreading materials at body temperature which may be brought into a state in which they spread even more easily by brief heating to temperatures of up to about 100° C. and preferably of up to about 60° C. In this form, they are particularly suitable for the mechanical coagulation of blood by application as known per se to body tissue, for example to damaged or otherwise opened bones. In the case of polycondensates of this type the molecular weight can be simply calculated from the components. For this purpose one first calculates the number of mols of hydroxy carboxylic acid used per mol of regulator or co-reactors such as glycerol in the product. This number is multiplied by the molecular weight of the monomeric hydroxy carboxylic acid minus 18, and the molecular weight of the regulator is added to it. In this manner one can also derive accurate molecular weights. For further details the reader is referred to: W. H. Carothers, et al., J. Am. Chem. So., Vol. 51, p. 2548, (1929) as well as P. J. Flory, Principles of polymer Chemistry, Cornell University Press, New York, (1953). The molecular weights that can be calculated in this way or can be determined via end group determinations are number averages EXAMPLES Examples 1 to 5 Procedure for the Preparation of Oligomer Reaction Products of Glycolic Acid with Glycerol Glycolic acid and glycerol are introduced in various molar ratios as shown in Table 1 into a three-necked flask equipped with a stirrer and distillation bridge; and the mixture is rapidly heated under nitrogen to 150° C. and then over a period of 6 hours from 150° to 200° C. Most of the water of reaction if eliminated which indicates the extent of completion of the ester condensation reaction. The reaction mixture is allowed to cool to around 150° C., carefully evacuated to 10 torr and the reaction completed at 200° C./10 torr. After 30 minutes, the product is packed hot at around 150° C. The composition of the reaction mixtures and the oligomer properties are shown in Table 1. Examples 6 to 8 Procedure of the Preparation of the Reaction Products of Glycolide with Glycerol Glycolide and glycerol were heated with stirring under nitrogen in a conventional laboratory apparatus, for 1 hour to 195° C. The reactants were then left to react for 3 hours at 195° C., and the reaction product subsequently packed while still hot. An Sn(II) chloride solution in ether was added as catalyst (7 ml of a solution of 2.5 g SnCl 2 in 1000 ml ether in the reaction of 3 mol glycolide with 1 mol glycerol). Examples 9 to 16 Procedure for the Preparation of the Reaction Products of Lactide with Glycerol In a conventional laboratory apparatus, lactide (L(-) lactid N, B of Beohringer Ingelheim) and glycerol were heated with stirring under nitrogen for 1 hour to 195° C. The reactants were then left to react for 3 hours at 195° C., and the reaction product subsequently packed while still hot. An Sn(II) chloride solution in ether was added as catalyst (7 ml of a solution of 2.5 g SnCl 2 in 1000 ml ether in the reaction of 3 mol lactide with 1 mole glycerol). Results are shown in Table 3. TABLE 1__________________________________________________________________________Oligohydroxycarboxylic acids from glycolic acid and glycerolRection Mixture YieldGlycolic acid Glycerol water of Viscosity atExamplemol mol reaction % measuring temperature Quality__________________________________________________________________________1 8 1 100 2450 mPas/65-70° C. highly viscous light yellow2 9 1 99.1 3950 mPas/65-70° C. soft, paste-like yellowish3 10 1 97 -- hard, wax-like, yellowish4 12 1 91.4 -- hard, white5 20 1 100 -- hard, white__________________________________________________________________________ TABLE 2______________________________________Oligohydroxycarboxylic acids from glycerol and glycolideReaction Mixture Content of free Glycerol Glycolide glycolic acid,Example mol mol Quality % by weight______________________________________6 1 4 soft, wax-like 0.05%7 1 4.5 hard, barely -- wax-like8 1 5 very hard, -- not wax-like______________________________________ TABLE 3__________________________________________________________________________Oligohydroxycarboxylic acids from glycerol and lactideReaction Mixture Content of freeGlycerol Lactide Viscosity at glycolic acid,Examplemol mol Quality measuring temperature % by weight__________________________________________________________________________ 9 1 2 viscous, clear 200 mPAS/65-70° C. --10 1 3 highly viscous, 850 mPAS/65-70° C. -- clear11 1 4 soft, clear 2300 mPAS/65-70° C. --12 1 5 soft, clear 2500 mPAS/65-70° C. 0.125%13 1 6 hard, formable, 4750 mPAS/65-70° C. 0.075% clear14 1 8 solid, brittle, 6000 mPAS/65-70° C. -- clear15 1 10 solid, brittle, 14000 mPAS/65-70° C. -- clear16 1 20 solid, brittle, cannot be measured -- clear__________________________________________________________________________ Examples 17 to 19 Purification of the Waxy Oligomer Reaction Product to Isolate Bone Waxes To remove free glycolic acid and other low molecular weight consitutents, the reaction products of Examples 2 to 4 were purified by reprecipitation. Procedure The waxy oligomer reaction products of Examples 2 to 4 based on glycolic acid were suspended in the same quantity by volume of acetone and then precipitated dropwise into 10 times the quantity of isopropanol. Isolation was followed by drying in a vacuum drying cabinet for 24 hours at 50° C. TABLE 4______________________________________ Unpurified Yield after Free wax of drying Appearance glycolicExample Example No. % by weight of Product acid______________________________________17 2 22.2% a soft paste, 0.0418 3 78% formable, -- wax-like19 4 66% barely wax- like, hard______________________________________

1a

The present invention relates to prosthetic acetabular cups. More particularly, it relates to prosthetic acetabular cups for use with a femoral head and neck prosthesis in effecting total hip joint replacements. Total hip replacement is said to cause changes in the pattern of stress transmission in the acetabular region. After joint replacement, the contact force at the cup surface tends to push the cup into the cancellous bone between the medial and lateral walls of the ilium. As a result, there is an increase in compressive stress in the cancellous bone immediately superior to the cup. In addition, the penetration of the cup into the cancellous bone tends to spread the walls of the ilium and create higher tensile and compressive stresses in the cancellous bone. Simultaneously, significant tensile stresses are created in the inferior portion of the cement layer. The stresses in the cancellous bone and cement after total hip replacement may relate to eventual loosening of the acetabular component. Acetabular component loosening is said to be the major long term complication in total hip replacement. This has been observed in the form of roentgenographic evidence of demarcation between cement and bone around the acetabular component. Loosening and migration of the acetabular cup may be related to progressive cracking of the cement and the accompanying biological response around the component. High stresses in the bone and/or poor bone quality contribute to these processes. There have been numerous prior art efforts to diffuse or control the stresses in the cement layer. These efforts include efforts to increase the stiffness of the acetabular cup, efforts to eliminate thin areas of cement which may fragment under heavy load and efforts to eliminate inconsistencies or foreign materials in the cement which may cause localized high stress points. Acetabular cups molded from a synthetic plastics material such as a high-density polyethylene are well known in the art. It is known to mold such cups with polyethylene spacer pegs or studs to establish a predetermined distance between the back of the cup and the underlying acetabulum. It is also well known in the art to increase the acetabular cup stiffness either by adding additional cement or a metal backing to the cup. This causes a more evenly distributed transfer of the stresses to the walls of the ilium. Increasing the stiffness of the acetabular cup by the addition of a metal backing distributes the stresses over a wider area, reducing peak stresses in the bone and cement. A greater portion of the strong cortical bone at the periphery of the cup bears a higher degree of load than with a relatively flexible acetabular component, and the relatively brittle bone cement is thereby provided with a degree of protection from excessively uneven loading. A metal backing in close contact with a polyethylene liner also limits the cold flow of the polyethylene and reduces the potential for distortion of the polyethylene liner with extended use. One commercially available acetabular prosthesis has a molded polyethylene liner with a number of molded on polyethylene spacer pegs backed by a titanium alloy shell. It is marketed by Biomet, Inc., Box 587, Airport Industrial Park, Warsaw, Ind. under the unregistered trademark "BIO-CLAD". Although the backing limits the cold flow of the liner, it does not eliminate or even minimize the cold flow. A gap has been found between the liner and the backing. This is believed to form after the molding process as the polyethylene cools. Polyethylene is known to shrink as it cools to room temperature. Also, the molded polyethylene spacers are believed to interrupt the cement layer and cause stress concentrators in a manner to be further explained below. U.S. Pat. No. 3,698,017 discloses a prosthetic acetabular device of generally hemispherical cup form and including a plurality of annular ribs formed around its outer surface which are said to reduce the possibility of the device being offset within the acetabulum. If the device were offset, the result could be to squeeze away most of the cement over a significant area apart from the groove passing through that area. Hence, through the use of at least three ribs including one adjacent to the rim of the cup, the device is said to provide greater uniformity to the cement layer formed between the cup and the acetabulum. The annular rib configuration, however, is believed to inhibit flow of the soft bone cement around the prosthesis as it is being positioned. Thus, areas closer to the rim of the cup may be left with relatively little cement as the soft cement mass is pushed medially with the introduction of the cup. Additionally, the presence of plastic ribs in the cement layer effectively separates the cement into a series of parallel interconnected discs rather than a more structurally sound hemispherical shape. Also, as noted above, a non-backed cup such as this one subjects the bone cement to non-uniform loading with substantial compressive stresses superiorly. U.K. Patent Application GB 2080118 A discloses another effort to insure an optimal cement layer thickness between the cup and the acetabulum. It discloses an unbacked acetabular cup having a number of bone cement receiving grooves formed in the external surface of the cup and ungrooved circumferential portions that support integral or inserted studs. The studs are said to act as spacers to facilitate the formation of a layer of bone cement of substantially constant thickness between cup and acetabulum. An integral flange around the circular periphery of the cup serves, in use, to apply pressure to the bone cement to push it into the bone and the grooves of the cup. While the spacers enable the surgeon to control cement thickness, each spacer is a foreign material once pressed within the cement. The presence of any foreign material effectively disrupts the cement mantle. It is well known that discontinuities in the cement create stress concentrators. The difference in compressive modulus between the stud material and the bone cement disrupts the smooth transfer of loads. Compressive modulus relates to the stiffness or load bearing ability of the material. It may be defined as the ratio of nominal compressive stress in the material at hand to corresponding strain below the proportional limit of the material. U.S. Pat. No. 3,285,071 discloses a prosthetic cement spacer for controlling the thickness of cement applied between a prosthetic insert and a support member such as an acetabulum. The spacers are described as comprising a generally cylindrical standoff body portion fabricated out of acrylic bone cement of the type normally supplied for surgical use and a pointed wire fabricated out of a steel alloy such as stainless steel. In use, the spacers are individually driven into the acetabular bone surface. The actual use of these individual spacers in an operating room is believed to be troublesome. They are made in different heights and with different wires requiring selection in the operating room. They must be individually driven into the acetabular bone. There is the risk that they may fall over or push out when the bone cement is introduced or when the acetabular cup is adjusted thereon. They require the use of additional instruments and related expertise to properly place them on the acetabular bone surface and to hold them in proper alignment while simultaneously driving them into the underlying bone. If misaligned, initially or during introduction of the bone cement into the acetabulum the thickness of the cement mantle may be adversely affected unbeknownst to the surgeon. The misalignment of a spacer may prevent the proper alignment of the prosthesis within the acetabulum. The advantage of spacers made of bone cement rather than polyethylene or metal or other materials is said to be their virtual elimination of an interface between the spacers and the bone cement where stresses are known to concentrate. The surface of the polymerized, acrylic bone cement spacers is said to repolymerize when the new acrylic bone cement is introduced, thereby effectively eliminating an interface. In the case of the spacers disclosed in U.S. Pat. No. 3,285,071 this advantage is not fully realized because of the presence of the pointed wires. The wires, because of their higher modulus, tend to introduce stress concentrations at the interface between the wires and their respective spacers. SUMMARY OF THE INVENTION According to the invention there is provided an integral prosthetic acetabular cup including an ultra-high molecular weight polyethylene liner in intimate contact with a suitable metal alloy shell and a plurality of integral standoff or spacer devices. The spacers are mechanically trapped between the liner and the shell to eliminate the need for additional wire-type locating devices, to prevent dislocation of the spacers during surgery and to simultaneously insure equidistant placement of the spacers around the circumference of the shell. The spacers are, preferably, comprised of polymethylmethacrylate, the primary constituent of currently approved bone cement. Polymethylmethacrylate spacers are said to chemically bond with the bone cement to virtually eliminate an interface between the spacers and the cement. The actual bond may be a chemical and/or mechanical bond formed by solvent cementing, thermal welding, the bone cement shrinking around the spacers or other process. Being of substantially the same material as the bone cement, the compressive modulus of the spacers is virtually the same as that of the bone cement. This relates to a comparably equal load bearing ability between the two materials and eliminates stress concentrators. By mechanically entrapping the spacers between the liner and the shell, rather than by molding the spacers as part of the liner or the shell, the spacers may develop as bone cements develop over time. Newer bone cements may comprise different materials. As the cements change, so may the spacers change without changing the existing liner or the existing shell. As noted earlier, the materials chosen for the liner and for the shell are chosen because of their bearing qualities, their strength, their stiffness and other factors. Their ability to bond to bone cement may not be a factor. The materials for spacers, may, preferably, be specifically chosen because of their ability to chemically bond to whatever bone cement is used. Additionally, it is believed that spacers having a compressive modulus similar to that of the bone cement used reduces or eliminates stress concentrators. By making the spacers separate from the liner and from the shell, the materials best suited for each of these items may be utilized. In this way, as the cements change, so may the spacers change to maintain comparable material properties. An integral, acetabular cup construction utilizing cement-like spacers facilitates operating room procedures. The use of additional instrumentation to place individual spacers on the acetabular bone is eliminated. The risk of human error associated with placing individual spacers on the bone is eliminated, i.e., that the spacers may not be uniformly distributed or the spacers are improperly attached or are attached to degenerated bone material. Also, the need for a multiplicity of separate spacers is eliminated. With an integral construction, the spacers are securely located on the liner. The spacers may be shaped to allow more universal fitting of the acetabular cup within the acetabulum. By giving the spacers a round or hemispherical shape, greater adjustment or flexibility in the placement of the acetabular cup within the acetabulum is allowed. Further, as an integral device, the opportunity for misplacement of separate devices has been eliminated. This eliminates another possibility for human error within the operating room. Perhaps most importantly, the use of an integral acetabular cup construction utilizing mechanically entrapped, cement-like spacers totally eliminates, for the first time, discontinuities and/or interfaces within the cement mantle at which objectionable stress concentrations may appear. Other objects and advantages of the invention will become more apparent from the following drawings wherein like numerals refer to like parts, the accompanying description and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of the assembled acetabular cup with portions broken away and portions in section. FIG. 2 is an exploded perspective view of the acetabular cup of FIG. 1 with portions broken away and portions in section to illustrate an inner liner, spacers and a metal backing. FIG. 3 is a sectional view of the acetabular cup of FIG. 1 cemented to the acetabulum. FIG. 4 is a sectional view of the metal backing portion of the acetabular cup of FIG. 2. FIG. 5 is a bottom view of the metal backing of FIG. 4. FIG. 6 is a sectional view of the inner liner portion of the acetabular cup of FIG. 2. FIG. 7 is a bottom view of the inner liner of FIG. 6. FIG. 8 is a side elevational view of the spacers of the acetabular cup of FIG. 2. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the drawings wherein like reference characters designate like parts throughout the several views, an integral acetabular cup assembly 2 is shown. As may best be seen in FIG. 2, assembly 2 includes an inner liner 4, a series of spacers 6 and a metal backing 8. Referring to particular to FIG. 6 and FIG. 7, liner 4 is shown separately in sectional view and bottom view respectively. Liner 4 includes an inner surface 10 and an outer surface 12. Inner surface 10 and outer surface 12 are generally hemispherical in shape. Inner surface 10 terminates at beveled annular surface 14. Outer surface 12 terminates at annular lip 23. Lip 23, in turn, is connected to notch 16 which is comprised of side walls 17, 19 and 21. The surface area between beveled surface 14 and notch 16 comprises an annular, peripheral rim 18. Rim 18 includes a beveled surface 20 connected to sidewall 17 and a top surface 22 connected to beveled surface 14. Surfaces 20 and 22 are connected at radius 24. In use, inner surface 10 of liner 4 provides the bearing surface for a femoral head used in effecting a total hip replacement. The femoral head and related neck prosthesis used in effecting total hip joint replacement has not been shown as well known in the art. The femoral head which is ultimately chosen for use with liner 4 and the manner in which the femoral head and liner 4 are sized are also well known in the art and form no part of the present invention. Inner liner 4 may be molded or machined from a synthetic plastics material such as a high density polyethylene. An ultra-high molecular weight polyethylene provides proven bearing surface and is generally preferable for receiving the head of the femoral prosthesis. Metal backing 8, on the other hand, may be made of a titanium alloy or other bicompatible metal. The preferred embodiment is machined from titanium-6 alluminum-4 vanadium, ELI grade, bar stock. Such metallic material is commonly used in implants because of its good bio-compatibility, and its relative low modulus of elasticity. The cross-sectional thicknesses of metal backing 8 is generally a uniform 2 millimeters. This is reduced in the area of the grooves as will be explained hereinafter. Metal backing 8 may be best described in connection with FIG. 4 and FIG. 5. It generally comprises an inner surface 26 and an outer surface 28 with four apertures therebetween labeled 30 and 32. Metal backing 8 is generally hemispherical in shape with aperture 32 at its apex. Apertures 30 are preferably radially disposed from and equidistant from aperture 32. Apertures 30 and 32 may preferentially be substantially similiar in size and shape. As perhaps best shown in connection with FIG. 4, apertures 30 and 32 are generally cylindrical and counterbored. They include larger cylindrical walls 34, small cylindrical walls 36 and interconnecting wall 38. Inner surface 26 of metal backing 8 extends radially outward from central aperture 32 to beveled seat 40. Seat 40 is annularly disposed on inner surface 26 and is connected between inner surface 26 and notch 42. The other side of notch 42 is connected to annular lip 44. Notch 42, as well as lip 44, is angularly disposed around the circumference of inner surface 26. Inner surface 26 and outer surface 28 are connected by top surface 46. Outer surface 28 includes equatorial grooves 48 and polar grooves 50. Equatorial grooves 48 may be best seen in reference to FIG. 2 and FIG. 4. Polar grooves 50, on the other hand, are best seen in FIG. 2 and FIG. 5. The purposes and advantages in grooves 48 and 50 will be described hereinafter. Referring to FIGS. 2 and 8, the spacers 6 will be described in detail. Spacers 6 are comprised of a generally cylindrically-shaped head portion 52 and a generally hemispherically-shaped body 54. Depending upon the spacer used, they may in addition preferentially include a second cylindrical shank portion 56 to provide additional overall height to the spacers 6. Cylindrical portion 52 is connected to cylindrical portion 56 or hemispherical portion 54 by surface 58. The tops of spacers 6 are comprised of a substantially circular and planar surface 60. Spacers 6 are preferably made of polymethylmethacrylate as noted earlier. Spacers 6 with an overall height of 3 mm beyond outer surface 28 have been found to be preferred. This is generally considered to be the optimum cement thickness. Any number of spacers 6 may be used in any distribution that will fit a hemisphere. Polymethylmethacrylate bone cement is known to be compatible with all modern prostheses and techniques. The surface of the polymerized acrylic spacers 6 is said to chemically bond when the new cement dough is introduced. This bond is said to eliminate any type of stress riser that may otherwise arise due to the insertion of the spacer within the acetabulum. Hemispherical portion 54 of spacers 6 allows greater flexibility of positioning of acetabular cup assembly 2 within the acetabulum. Prior to insertion into the acetabulum, inner liner 4, spacer 6 and metal backing 8 must be assembled. First, metal backing 8 is machined from titanium-6 aluminum-4 vanadium, ELI grade bar stock as noted earlier. Next, inner liner 4 is machined from ultra-high molecular weight polyethylene. Spacers 6 are preferably injection molded from polymethylmethacrylate. At room temperature, spacers 6 are dropped into apertures 30 and 32. The outer surfaces of spacers 6 are dimensionally suited and adapted to substantially contact their mating surfaces of apertures 30 and 32. More particularly, walls 34 are juxtapositioned against cyclindrical portions 52, walls 38 contact surfaces 58, and walls 36 are juxtapositioned with surfaces 56. Next, inner liner 4 is chilled in liquid nitrogen. Being careful not to mar any of the surfaces of inner liner 4, inner liner 4 is placed within metal backing 8. As inner liner 4 warms to room temperature, it expands to a close fit within the metal backing 8. Surfaces 12 and 26 are preferably contacted throughout their interface. This mechanically entraps spacers 6 within their respective apertures 30 and 32, and eliminates the potential for liner 4 to cold flow into any gap that might otherwise exist between surfaces 12 and 26. Once the assembly is completed and warmed to room temperature, inner liner 4 is mechanically locked within metal backing 8 by the interaction of annular notch 16, annular ridge 23 and annular lip 44. Lip 44 fits snugly within notch 16. Lip 23 is juxtaposed to seat 40 and fits snugly within annular notch 42 to prevent the disassociation of inner liner 4 and backing 8. It has been found that the tolerances on inner liner 4 and metal backing 8 can be closely controlled to achieve the intimate contact required to effectively limit cold flow deformation of the preferred polyethylene liner 4. The placement of integral acetabular assembly 2 within the acetabulum is shown in FIG. 3. The surgical procedure for inserting assembly 2 within the acetabulum is to prepare the acetabulum by reaming the generally spherical bone surface 61 to a spherical diameter size which is generally equal to the diameter of radius 24 of rim 18. In this manner, the acetabulum will be prepared with an increased size in order to accomodate the additional height or thickness of spacers 6 and yet still position the acetabular cup assembly 2 in the correct position. During this reaming procedure, instruments may be placed in position to check for evenness of reaming and correct alignment. It is important that the acetabulum be cleaned and dried prior to introduction of the acrylic bone cement 62 into the interface. Care should also be taken not to handle the spacers 6 in order to prevent coating spacers 6 with contaminate materials which could impede the polymerization process. After the acrylic bone cement has been inserted and pressurized on surface 61, acetabular cup assembly 2 is manually pushed into position until it is felt to rest against bone surface 61. At this time, it is possible to firmly hold the acetabular cup in place and simultaneously allow the surgeon to use both hands to smooth and effectively pack the cement around the acetabular cup. Once this packing is completed, the area is trimmed and a smooth surface formed. When seating assembly 2 within the acetabulum, beveled surface 20 of rim 18 serves to further pressurize the acrylic bone cement 62. The hemispherical portion 54 of spacers 6 further tends to eliminate occlusions in the cement 62 and aid in the placement of assembly 2 upon surface 61 by not being sensitive to positioning. By this it is meant that, regardless of orientation or biasing within the acetabulum, each of spacers 6 will have a substantially identical point contact with surface 61. This insures a uniform thickness to bone cement 62 and further minimizes the possibility of unintentionally forming stress risers within the bone cement. Equatorial grooves 48 and polar grooves 50 tend to enhance fixation of the prosthesis to the cement layer. Grooves 48 and 50 are generally hemispherical in cross section and preferably radiused at the periphery to avoid stress risers and to insure even and complete filling of grooves 48 and 50 with bone cement 62 when assembly 2 is pressed into the acetabulum. Grooves 48 and 50 are preferably, approximately 1.5 mm deep. Equatorial grooves 48 interlock with bone cement 62 to provide additional stability to assembly 2 during the tension/compresion loading encountered in use. Polar grooves 50 also interlock with cement 62 to provide additional stability to assembly 2. The stability added by grooves 50 is primarily against the torsional forces encountered during use. From the foregoing, it will be apparent that all of the objectives of this invention have been achieved by the acetabular cup assembly shown and described. It will also be apparent that various modifications and changes may be made by those skilled in the art without departing from the spirit of the invention as expressed in the accompanying claims. Therefore, all matter shown and described is to be interpreted as illustrative and not in a limiting sense.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is related to a golf bag, and more particularly to a golf bag that can be stably stood obliquely and has a simplified cord linking design. 2. Description of the Related Art In consideration of firmly laying golf bags in all terrain of golf courses and easily accessing clubs inside the golf bags, obliquely laying golf bags on the ground with the support of a bipod can be an ideal way. With reference to FIG. 9 , a conventional golf bag with an integral bipod stand has a bag body 91 , two legs 92 , a pivot bracket 93 , two activating rods 94 and multiple guide brackets 95 . The bag body 91 has an open top, a bottom and a sidewall. The legs 92 are attached pivotally on the sidewall of the bag body 91 close to the top, and each leg 92 has a proximal end. The pivot bracket 93 is mounted pivotally on the bottom of the bag body 91 , has a flat bottom and contacts the ground when the golf bag 91 stands on the ground. The activating rods 94 are connected pivotally to the pivot bracket 93 , and each activating rod 94 has a distal end. The distal ends of the activating rods 94 are pivotally attached respectively to the legs 92 near the proximal ends of the legs 92 . The guides 95 are mounted on the sidewall, and each guide 95 has two through holes through which the activating rods 94 respectively extend. Inclining the bag body 91 relative to the pivot bracket 93 causes the activating rods 92 to pivot the legs 92 away from the bag body 91 so that the golf bag can stand obliquely and stably on the ground. However, the activating rods 94 are exposed and are easily damaged or broken in the course of normal uses, and dust, dirt corrosion or other debris easily accumulates in the through holes in the guides 95 and restricts the movement of the activating rods 94 through the guides 95 . Besides, the exposed activating rods 94 are not aesthetically appealing and the golf bag obliquely standing on the ground with an edge of the bottom facing the legs 92 and a part of the pivot bracket 93 is not stably enough. According to U.S. Pat. No. 7,494,009,, entitled to “Golf Bag Frame With A Leg Assembly”, the golf bag can fulfill the purpose of obliquely standing on the ground with a base and two legs pulled to extend out by a cord extending from the distal end of two activating lever and a foot of the base. The drawback of the '009, Patent is that such a golf bag requires more effort in designing the top frame to allow the cord to penetrate through a passage defined through the top frame. With reference to FIG. 10 , another conventional golf bag has a bag body 7 , a pivoting base 8 and a rear post 6 . The bag body 7 has a bottom and a front portion. The rear post 6 is mounted on the bottom of the bag body 7 to support the weight of bag body 7 . The pivoting base 8 is mounted on the bottom of the bag body 7 and has a bottom 81 , a sidewall 82 , two pivot balls 83 and a mounting bracket 84 . The rear post 6 is mounted on the rear of the bottom 81 of the pivoting base 8 to support the weight of the bag body 7 and the weight of all clubs in the bag body 7 . The sidewall 82 is formed on and protrudes upward from the bottom 81 . The pivot balls 83 are mounted on the sidewall 82 . The mounting bracket 84 is mounted on the sidewall 82 at a position away from the pivot balls 83 . The pivot bracket 84 is mounted pivotally on the sidewall 82 . With the pivoting base 8 , the golf bag can obliquely stand on the ground more firmly than the golf bag with an integral bipod stand as shown in FIG. 9 . However, the issue that the exposed activating rods are easily damaged or not aesthetically appealing still exists. Furthermore, due to the tilting angle of the golf bag, the weight of the golf bag and all clubs therein leaning forwards crumples and shortens the front portion of the bag body 7 . Accordingly, a front post mounted on the front of the pivoting base 8 is inappropriate. Hence, the major support of the overall weight of the golf bag relies on the rear post, but this causes the rear post thick and heavy and the golf bag not stable upon standing. SUMMARY OF THE INVENTION The objective of the present invention is to provide a golf bag that can be stood obliquely in stable and has a simplified cord linking design. To achieve the foregoing objective, the golf bag has a bag body, a bottom frame, a top frame, two legs, multiple posts and a cord. The bag body is barrel-like and has a top opening and a bottom opening. The bottom frame is mounted on the bottom opening of the bag body and has a cover and a bottom cuff. The cover has a top, a top opening, a cover bottom, a cover sidewall, a chamber and a stopper. The top opening is formed through the top of the cover. The cover bottom is opposite to the top opening and has a front portion. The cover sidewall is formed on and protrudes upwardly from a perimeter of the cover bottom. The chamber is defined by the cover sidewall and communicates with the top opening of the cover. The stopper is formed on and protrudes upwardly from the front portion of the cover bottom. The bottom cuff is received in chamber of the cover and has a front portion, a cuff bottom, a cuff sidewall, two pivot elbows, a lever holder, a lever and multiple bottom post holders. The cuff bottom has a bevel surface formed on the front portion of the cuff bottom. The cuff sidewall is formed on and protrudes upwardly from a perimeter of the cuff bottom. The two pivot elbows are oppositely and pivotally mounted on an inside of the cover sidewall and a periphery of the cuff sidewall, and abut the front portion of the cover bottom. The lever holder is hollow, formed on an inside of the cuff sidewall to align with the stopper, and has a through hole formed through a top of the lever holder. The lever is received and pivotally mounted in the lever holder. The bottom post holders are tubular and mounted on the cuff bottom. The top frame is mounted on the top opening of the bag body and has a top sidewall, a divider, multiple top post holders, a cord guide and two leg holders. The top sidewall has an inner surface. The divider is attached to the inner surface of the top sidewall to divide a space inside the top sidewall into multiple sub spaces. The top post holders are formed on the inner surface of the top sidewall to correspond to the bottom post holders. The cord guide is mounted on the top sidewall and the bag body and has a branching channel formed on the cord guide. The two leg holders are pivotally mounted on a periphery of the top sidewall, penetrate through the top sidewall to abut against the cord guide. The two legs are respectively connected to the leg holders. Each of the posts has two ends respectively mounted in one of the top post holders and a corresponding one of the bottom post holders. The cord has a first end and a second end. The first end is tied to the lever of the bottom cuff. The second end has two branches penetrating through the lever holder and the branching channel of the cord guide and respectively tied to the leg holders. When the golf bag is tilted, the bevel surface rests on the cover, the cord is pulled to expand the two leg holders and the two legs to stand on the ground. As the cover stay fully lying on the ground when the bottom cuff tilts, the golf bag of the present invention can stably stand and requires a simplified cord linking design. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a golf bag in accordance with the present invention; FIG. 2 is an exploded perspective view of a bottom frame of the golf bag in FIG. 1 ; FIG. 3 is an exploded perspective view of a top frame of the golf bag in FIG. 1 ; FIG. 4 is a side view of the golf bag in FIG. 1 ; FIG. 5 is an enlarged side view in partial section of the bottom frame of the golf bag in FIG. 1 ; FIG. 6 is an operational side view of the golf bag in FIG. 1 showing the golf bag in an obliquely laying condition; FIG. 7 is an enlarged operational front view in partial section of the bottom frame of the golf bag in FIG. 6 ; FIG. 8 is an operational perspective view of the golf bag in FIG. 6 showing the golf bag in the obliquely laying condition; FIG. 9 is a perspective view of a conventional golf bag; and FIG. 10 is a perspective view of another conventional golf bag. DETAILED DESCRIPTION OF THE INVENTION With reference to FIG. 1 , a golf bag in accordance with the present invention has a bag body 1 , a bottom frame 2 , a top frame 3 , two legs 4 , multiple posts 5 and a cord 6 . With reference to FIGS. 2 , 4 and 5 , the bag body 1 is barrel-like and has a top opening and a bottom opening. The bottom frame 2 is mounted on the bottom opening of the bag body 1 and has a cover 21 and a bottom cuff 22 . The cover 21 has a top, a top opening 211 , a cover bottom 212 , a cover sidewall 213 , a chamber 214 , a stopper 215 and two first pivot pins 216 . The top opening 211 is formed through the top of the cover 21 . The cover bottom 212 is opposite to the top opening 211 and has a front portion. The cover sidewall 213 is formed on and protrudes upwardly from a perimeter of the cover bottom 212 . The chamber 214 is defined by the cover sidewall 213 and communicates with the top opening 211 . The stopper 215 is formed on and protrudes upwardly from the front portion of the cover bottom 212 . The two first pivot pins 216 are oppositely mounted on an inside of the cover sidewall 213 and is adjacent to the front portion of the cover bottom 212 . The bottom cuff 22 is received in chamber 214 of the cover 21 and has a cuff bottom 221 , a cuff sidewall 222 , two second pivot pins 223 , two pivot elbows 224 , a lever holder 225 , a lever 226 and multiple bottom post holders 227 . The cuff bottom 221 has a front portion and a bevel surface 2211 . The bevel surface 2211 is formed on the front portion of the cuff bottom 221 . The cuff sidewall 222 is formed on and protrudes upwardly from a perimeter of the cuff bottom 221 . The two second pivot pins 223 are oppositely mounted on a periphery of the cuff sidewall 222 and respectively correspond to the two first pivot pins 216 . The two pivot elbows 224 are V-shaped and has two arms 2241 and two holes 2242 . Each of the two arms 2241 has an elbow end 2243 and a free end 2244 . The elbow ends 2243 of the two arms 2241 are connected with each other. The hole 2242 is formed through the free end 2244 of the arm 2241 . The holes 2242 of each pivot elbow 224 are mounted rotatably around the corresponding first pivot pin 216 and second pivot pin 223 , and the free ends 2244 of the two pivot elbows 224 face the front portion of the cuff bottom 221 . The lever holder 225 is hollow, is dome-shaped, is formed on an inside of the cuff sidewall 221 , aligns with the stopper 215 and has a through hole 2251 formed through a top of the lever holder 225 . The lever 226 has a disk portion 2261 and an elongated portion 2262 integrally formed with the disk portion 2261 . The disk portion 2261 of the lever 226 is received in the lever holder 225 and pivotally mounted on an inner wall of the lever holder 225 , and has a groove 2263 partially formed in a perimeter of the disk portion 2261 . The elongated portion 2262 abuts against the cover bottom 212 of the cover 21 and one side of the stopper 215 . The multiple bottom post holders 227 are tubular and are mounted on and protrude from the cuff bottom 221 . With reference to FIG. 3 , the top frame 3 is mounted on the top opening of the bag body 1 and has a top sidewall 31 , a divider 32 , multiple top post holders 33 , a cord guide 34 and two leg holders 35 . The top sidewall 31 has two slots 311 and two seats 312 . The slots 311 are formed through the top sidewall 31 and corresponding to the lever holder 225 of the bottom cuff 22 respectively. Each of the seats has two walls formed beside the corresponding slots 311 . The divider 33 has a mesh form and is attached to an inner surface of the top sidewall 31 to divide a space inside the top sidewall 31 into multiple sub spaces. The top post holders 33 are formed on the inner surface of the top sidewall 31 and correspond respectively to the bottom post holders 227 . The cord guide 34 has a shape in reverse isosceles triangle, is mounted on the top sidewall 31 and the bag body 1 , and has a Y-shaped branching channel 341 . The branching channel 341 is formed in a back of the cord guide 34 and has a longitudinal portion 3411 and two branch portions 3412 . The two branch portions 3412 are V-shaped and connected with the longitudinal portion 3411 . The branch portions 3412 of the cord guide 34 are respectively aligned with the slots 311 on the top sidewall 31 . The two leg holders 35 are pivotally mounted on a periphery of the top sidewall 31 . Each of the two leg holders 35 has a pivot shaft 350 , a cord receiving portion 351 , a leg holding portion 352 and a torsion spring 354 . The pivot shaft 350 is pivotally mounted through the walls of the corresponding seat 312 . The cord receiving portion 351 is semicircular, has a groove 353 formed in an circular edge of the cord receiving portion 351 , is mounted through one of the slots 311 on the top sidewall 31 and is mounted in a corresponding branch portion 3412 of the branching channel 341 . The leg holding portion 352 is tubular and has a closed end and an open end. The closed end has two wings 3521 formed on the closed end and the cord receiving portion 351 is mounted between the two wings 3521 . The torsion spring 354 is mounted around the corresponding pivot shaft 350 . Each of the two legs 4 is mounted in the open end of the leg holding portion 352 of one of the leg holders 35 . Each of the multiple posts 5 has two ends respectively mounted in one of the top post holders 33 and a corresponding one of the bottom post holders 227 . In the present embodiment, three posts 5 are implemented, and one in the back and two in the front of the bag body 1 . The cord 6 may be a fiber cord or a metal cable and has a first end and a second end. The second end of the cord 6 has two branches 11 . The first end of the cord 6 is tied to the lever 226 and received in the groove 2263 of the lever 226 . The second end penetrates through the through hole 2251 of the lever holder 225 . The second end further penetrates through the longitudinal portion 3411 and the two branches are respectively mounted through the two branch portions 3412 . After being mounted through the two branch portions 3412 of the branching channel 341 , the two branches 11 of the cord 6 are respectively received and tied in the grooves 353 of the cord receiving portions 351 of the leg holders 35 . With reference to FIGS. 4 and 5 , when the golf bag stands upright, the disk portion 2261 of the lever 226 is received in the lever holder 225 and the elongated portion 2262 of the lever 226 abuts against the cover bottom 212 of the cover 21 and the stopper 215 . The free ends 2244 of two arms 2241 of each of the two pivot elbows 224 all directly face the front portion of the cover 21 . Two legs 4 are folded and attached to the bag body 1 . With reference to FIGS. 6 and 7 , when the golf bag is leaned forwards, the front portion of the bottom cuff 22 tilts down and the bevel surface 2211 rests on the cover bottom 212 of the cover 21 . The elongated portion 2262 of the lever 226 is pushed against by the cover bottom 212 of the cover 21 to pivot the disk portion 2261 relative to the lever holder 225 until the lever 226 lie on the cover bottom 212 and is blocked by a bottom edge of the cuff sidewall 221 . When the lever 226 lies on the cover bottom 212 , the cord 6 tied inside the groove 2263 of the disk portion 2261 is pulled downwardly. The two branches 11 of the cord 6 respectively received in the grooves 353 of the cord receiving portions 351 of the leg holders 35 are also moved downward to pivot the two leg holding portions 352 forward. Accordingly, the two leg holders 35 with the two legs 4 are expanded for obliquely standing on the ground as shown in FIG. 8 . When the golf bag of the present invention is tilted, the cover 21 is kept to lie flatly on the ground. With the two legs 4 and a full contact of the cover bottom 212 on the ground, the golf bag can be held on the ground stably. With the cord 6 being connected between the lever 226 of the bottom cuff 22 and the cord guide 34 of the top frame 3 , a passage defined in the divider 32 for the cord passing therethrough is unnecessary. The structure of the golf bag and the manufacturing and assembling processes for the same can be simplified. Whenever the golf bag is tilted, the full contact of the cover on the ground prevents the front portion of the bag body 1 from being crumpled and shortened. Accordingly, multiple posts can be mounted in the front and back of the bag body to evenly share the weight of the golf bag and the clubs therein, and the posts can be lighter and thinner without causing the golf bag unstable upon standing. Even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only. Changes may be made in detail, especially in matters of shape, size, and arrangement of parts within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

1a

Cross-Reference to Related Applications [0001] This is a non-provisional application relating to U.S. Provisional Patent Application No. 60/261,146 filed Jan. 12, 2001 and U.S. Provisional Patent Application No. 60/306,774 filed Jul. 20, 2001. FIELD OF THE INVENTION [0002] The present invention relates to display systems and, more particularly, to a merchandise display system of a gravity-feed type. BACKGROUND OF THE INVENTION [0003] In the past, various systems have been used for displaying merchandise packages (see, e.g., U.S. Pat. Nos. 4,479,583; 4,616,753; 5,180,128; 5,626,243; and 5,762,207). For instance, with reference to FIGS. 15 and 16, a conventional gravity-fed peg hook display system A is provided with a peg hook B adapted to be mounted from a pegboard C. When mounted, the peg hook B is angled downwardly relative to the pegboard C such that packages D loaded thereon are fed automatically in a forward direction (as indicated by arrow E in FIG. 15). Because the display system A is not provided with guide mechanisms for properly orienting displayed packages, the packages D tend to become arranged in a disorderly and disorganized manner. For instance, the packages D located at the front end of the display system A tend to tilt upwardly (as indicated by arrow F in FIG. 15) by the weight of the packages D located at the rear end of same. As a result, at least some of the packages D do not assume an upright or vertical position. Moreover, the packages D tend to stick or swing out laterally (as indicated by arrows G in FIG. 16), thereby making them appear disorderly and disorganized. [0004] U.S. Pat. Nos. 4,742,923, 5,855,282 and 6,092,674 disclose package display systems. While these systems are equipped with some form of guide mechanisms, they suffer from various problems and shortcomings. For instance, these display systems are not adapted for easy adjustability for accommodating packages having different sizes. In such circumstances, there is a need for a merchandise display system addressing problems associated with conventional merchandise display systems. SUMMARY OF THE INVENTION [0005] The present invention overcomes the disadvantages and shortcomings of the prior art discussed above by providing a new and improved merchandise display system. More particularly, the merchandise display system includes a suspending mechanism for suspending a plurality of articles therefrom. The suspending mechanism has a suspending member sized and shaped so as to extend from a support member in a generally downward direction such that the plurality of articles can be fed downwardly along the suspending member. A guiding mechanism is also provided for positioning the plurality of articles in proper orientation. The guiding mechanism includes a guiding member sized and shaped so as to extend from the support member and engageable with side portions of the plurality of articles. The guiding member also includes an end sized and shaped so as to wrap around a lower front portion of an article located at a forward end of the plurality of articles for orienting the plurality of articles in a substantially upright orientation. The merchandise display system can also be provided with a supporting mechanism for supporting thereon the plurality of articles suspended from the suspending mechanism. [0006] In accordance with one embodiment of the present invention, the suspending mechanism, the supporting mechanism and the guiding mechanism can be formed as independent and discrete members which can be independently and selectively mounted to a support panel of the support member. In accordance with another embodiment of the present invention, the suspending mechanism and the guiding mechanism can be formed as a single assembly. In accordance with yet another embodiment of the present invention, the suspending mechanism and the guiding mechanism can be supported from a horizontal support tube of the support member. BRIEF DESCRIPTION OF THE DRAWINGS [0007] For a better understanding of the present invention, reference is made to the following detailed description of exemplary embodiments, considered in conjunction with the accompanying drawings, in which: [0008] [0008]FIG. 1 is a perspective view of a merchandise display system constructed in accordance with a first embodiment of the present invention; [0009] [0009]FIG. 2 is a perspective view of the display system shown in FIG. 1 and mounted to a pegboard; [0010] [0010]FIG. 3 is a side schematic view of the display system shown in FIG. 2; [0011] [0011]FIG. 4 is a perspective view of a modified version of the display system shown in FIGS. 1 - 3 ; [0012] [0012]FIG. 5 is a perspective view of another modified version of the display system shown in FIGS. 1 - 3 ; [0013] [0013]FIG. 6 is a perspective view of a merchandise display system constructed in accordance with a second embodiment of the present invention; [0014] [0014]FIG. 7 is a perspective view of the display system shown in FIG. 6 and mounted to a pegboard; [0015] [0015]FIG. 8 is a side schematic view of the display system shown in FIG. 7; [0016] [0016]FIG. 9 is a perspective view of a merchandise display system constructed in accordance with a third embodiment of the present invention; [0017] [0017]FIG. 10 is a side schematic view of a merchandise display system constructed in accordance with a fourth embodiment of the present invention; [0018] [0018]FIG. 11 is a perspective view of a merchandise display system constructed in accordance with a fifth embodiment of the present invention; [0019] [0019]FIG. 12 is an enlarged perspective view of a section of the display system shown in FIG. 11; [0020] [0020]FIG. 13 is a side schematic view of the section shown in FIG. 11; [0021] [0021]FIG. 14 is a view illustrating a modified version of an attachment mechanism of the display system shown in FIG. 11; [0022] [0022]FIG. 15 is a side schematic view of a conventional merchandise display system; and [0023] [0023]FIG. 16 is a front schematic view of the conventional display system shown in FIG. 15. DETAILED DESCRIPTION OF THE INVENTION [0024] Although the present invention can be used in conjunction with any type of merchandise display systems, it is particularly suitable for use in connection with a gravity-feed display system. Accordingly, the present invention will be described hereinafter in connection with such a display system. It should be understood, however, that the following description is only meant to be illustrative of the present invention and is not meant to limit the scope of the present invention, which has applicability to other types of display systems. [0025] [0025]FIGS. 1 and 2 show a merchandise display system 10 constructed in accordance with a first embodiment of the present invention. More particularly, the display system 10 is provided with a pegboard 11 having a plurality of openings 12 . The display system 10 also includes a peg hook 14 having a pair of prongs 16 which are sized and shaped so as to be inserted into a pair of adjacent openings 12 for removably mounting the peg hook 14 to the pegboard 11 . A peg rod 18 is fixedly attached to the prongs 16 such that when the peg hook 14 is mounted to the pegboard 11 , the rod 18 extends from the pegboard 11 in a generally downward manner (see FIG. 3). The rod 18 also includes an end portion 20 located opposite the prongs 16 and angled upwardly with respect to the rest of the rod 18 . [0026] Referring to FIGS. 1 and 2, the display system 10 also includes a support hook 24 equipped with a bracket 26 at one end thereof. The bracket 26 is provided with a pair of prongs 28 which are sized and shaped so as to be inserted into a pair of adjacent openings 12 of the pegboard 11 for removably mounting the support hook 24 to the pegboard 11 . A U-shaped support rod 30 is fixedly attached to the bracket 26 such that when the support hook 24 is mounted to the pegboard 11 , the support rod 30 extends from the pegboard 11 in a generally downward manner (see FIG. 3). [0027] Still referring to FIGS. 1 and 2, the display system 10 also includes a guide hook 34 equipped with a bracket 36 at one end thereof. The bracket 36 is provided with a pair of prongs 38 which are sized and shaped so as to be inserted into a pair of adjacent openings 12 of the pegboard 11 for removably mounting the guide hook 34 to the pegboard 11 . The guide hook 34 includes a U-shaped guide rod 40 having a guide section 42 , which is fixedly attached to the bracket 36 , and a stop section 44 , which projects from an end of the guide section 42 . The stop section 44 is oriented at an angle (e.g., a 90° angle) with respect to the guide section 42 for purposes to be discussed hereinafter. The guide and stop sections 42 , 44 are sized and shaped such that when the guide hook 34 is mounted to the pegboard 11 , the guide section 42 is oriented substantially perpendicular to the pegboard 11 (i.e., extends horizontally) and the stop section 44 extends substantially parallel to the pegboard 11 (see FIG. 3). [0028] For displaying merchandise packages 80 , the peg hook 14 is mounted to the pegboard 11 at a desired location (see FIGS. 2 and 3). The packages 80 are then loaded to the peg hook 14 . Next, the support hook 24 is mounted to the pegboard 11 below the peg hook 14 such that the rod 18 of the peg hook 14 extends substantially parallel to the rod 30 of the support hook 24 and such that bottom ends 82 of the packages 80 are supported on the support rod 30 . The guide hook 34 is then mounted to the pegboard 11 between the peg hook 14 and the support hook 24 such that the guide section 42 is spaced from the peg hook 14 and the support hook 24 in a lateral direction (see FIGS. 1 and 2) and such that the stop section 44 is located above a front end of the support hook 24 (see FIGS. 2 and 3). More particularly, the guide section 42 is adapted to engage associated lateral sides 84 (see FIG. 2) of the packages 80 , while the stop section 44 is adapted to engage a lower portion 86 (see FIG. 3) of the front package 80 ′ (i.e., the package located at the forward end of the display system 10 ). When the front package 80 ′ is removed from the display system 10 , the remaining packages 80 are fed in a downward direction towards the end portion 20 of the peg hook 14 (i.e., they slide along the rod 18 of the peg hook 14 and the rod 30 of the support hook 24 ). [0029] It should be appreciated that the peg hook 14 , the support hook 24 and the guide hook 34 cooperate with one another so as to maintain the packages 80 in orderly and organized fashion (e.g., in a linear and upright orientation). For instance, the weight of the packages 80 is supported not only by the peg hook 14 but also by the support hook 24 . As a result, the peg hook 14 is inhibited from over-bending. In this regard, the U-shaped rod 30 of the support hook 24 functions to distribute the weight of the packages 80 evenly, thereby providing enhanced stability to the packages 80 and reducing the amount of stress applied to the peg hook 14 by same. Moreover, the guide section 42 of the guide hook 34 is adapted to engage the lateral sides 84 of the packages 80 , thereby inhibiting same from sticking out laterally. For example, when the front package 80 ′ is removed from the display system 10 and the remaining packages 80 are hence fed in a downward direction toward the end portion 20 of the peg hook 14 , the guide section 42 inhibits the remaining packages 80 from swinging laterally and thereby maintains same in a substantially linear orientation (see FIG. 2). In addition, the stop section 44 of the guide hook 34 engages the lower portion 86 of the front package 80 ′ such that the front package 80 ′ and hence the remaining packages 80 are inhibited from tilting upwardly (see FIG. 3). In other words, the stop section 44 maintains the packages 80 in a substantially upright (i.e., vertical) position. [0030] It should also be appreciated that because the peg hook 14 , the support hook 24 and the guide hook 34 are formed as independent and discrete members removably mounted to the pegboard 11 , they provide enhanced adjustability for accommodating packages having different sizes and/or shapes. More particularly, because the peg hook 14 , the support hook 24 and the guide hook 34 can be independently and selectively mounted to the pegboard 11 at infinitely varying locations with respect to one another, they are adapted for universal use in connection with a number of merchandise packages having many different sizes and/or shapes. [0031] It should be noted that the display system 10 can have numerous modifications and variations. For instance, the display system 10 can be used without the support hook 24 or the guide hook 34 . Further, the U-shaped guide hook 34 can be provided with a single rod construction (see, for instance, FIG. 4). Moreover, the U-shaped rod 30 of the support hook 24 can also be provided with a single rod construction similar to that of the guide hook 34 shown in FIG. 4. In addition, the mechanisms for mounting the peg hook 14 , the support hook 24 and the guide hook 34 to the pegboard 11 (i.e., the brackets 26 and 36 and prongs 16 , 28 , 38 ) are interchangeable and/or can be replaced with other conventional mounting mechanisms. Further, while the guide hook 34 is illustrated in FIGS. 1 - 3 as being located on the right side of the display system 10 , it can be located on the left side, provided that the stop section 44 is bent in an opposite direction (see, for instance, FIG. 5) The order of mounting the peg hook 14 , the support hook 24 and the guide hook 34 to the pegboard 11 can also be different from the one described above, depending upon user preferences, package sizes/shapes, etc. [0032] FIGS. 6 - 8 , FIG. 9, FIG. 10 and FIGS. 11 - 14 depict second, third, fourth and fifth embodiments, respectively, of the present invention. Elements illustrated in FIGS. 6 - 8 , FIG. 9, FIG. 10 and FIGS. 11 - 14 , which correspond, either identically or substantially, in function or structure to the elements described above with respect to the display system 10 of FIGS. 1 - 3 have been designated by corresponding reference numerals increased by one hundred, two hundred, three hundred and four hundred, respectively. Unless otherwise stated or illustrated herein, the embodiments of FIGS. 6 - 14 are constructed and operate in the same basic manner as the display system 10 of FIGS. 1 - 3 . [0033] [0033]FIGS. 6 and 7 show a merchandise display system 110 constructed in accordance with a second embodiment of the present invention. More particularly, the display system 110 is provided with a pegboard 111 having a plurality of openings 112 . The display system 110 also includes a peg hook unit 145 having an elongated support member 146 . The support member 146 has a rectangular shape and top and bottom portions 148 , 150 . Bridges 152 a , 152 b , 152 c are provided for interconnecting the top portion 148 of the support member 146 to the bottom portion 150 and are spaced substantially equally along the support member 146 . The support member 146 also includes a plurality of brackets 154 a , 154 b , 154 c which are fixedly attached to the bridges 152 a , 152 b , 152 c , respectively, as well as to the top portion 148 of the support member 146 . The brackets 154 a , 154 b , 154 c are provided with prongs 116 a , 116 b , 116 c , respectively, which are sized and shaped so as to be inserted into the openings 112 of the pegboard 111 for mounting the peg hook unit 145 to the pegboard 111 . Mounting hooks 114 a , 114 b , 114 c , 114 d extend from the support member 146 and include hook rods 118 a , 118 b , 118 c , 118 d , respectively. The rods 118 a , 118 b , 118 c , 118 d are provided with leg portions 156 a , 156 b , 156 c , 156 d , respectively. The leg portions 156 a , 156 b , 156 c , 156 d are fixedly attached to the top and bottom portions 148 , 150 of the support member 146 such that when the peg hook unit 145 is mounted to the pegboard 111 , the rods 118 a , 118 b , 118 c , 118 d extend from the pegboard 111 in a generally downward manner (see FIG. 8). The rods 118 a , 118 b , 118 c , 118 d also include reinforcing members 158 a , 158 b , 158 c , 158 d , respectively, connected to the top portion 148 of the support member 146 and the rods 118 a , 118 b , 118 c , 118 d , respectively, for purposes to be discussed hereinafter. Alternatively, the reinforcing members 158 a , 158 b , 158 c , 158 d can be attached to the leg portions 156 a , 156 b , 156 c , 156 d , respectively. The rods 118 a , 118 b , 118 c , 118 d also include upwardly angled end portions 120 a , 120 b 120 c , 120 d located opposite the leg portions 156 a , 156 b , 156 c , 156 d , respectively, functioning as a stop for packages supported therefrom. [0034] Still referring to FIGS. 6 and 7, the display system 110 also includes a retainer member 160 having laterally spaced horizontal sections 162 a , 162 b , laterally spaced angled sections 164 a , 164 b and a retainer section 166 . More particularly, the horizontal sections 162 a , 162 b are connected to the angled section 164 a , 164 b , respectively, which in turn are connected to the retainer section 166 . The retainer member 160 also includes brackets 136 a , 136 b provided with prongs 138 a , 138 b , respectively, for mounting the retainer member 160 to the pegboard 111 . The brackets 136 a , 136 b are fixedly attached to ends of the horizontal sections 162 a , 162 b , respectively, such that when the retainer member 160 is mounted to the pegboard 111 , the horizontal sections 162 a , 162 b extend from the pegboard 111 in a substantially horizontal fashion, the angled sections 164 a , 164 b are oriented at a downward angle with respect to the pegboard 111 and the retainer section 166 is substantially parallel relative to the pegboard 111 . Guide rods 140 a , 140 b , 140 c project from the retainer section 166 at a direction substantially parallel to the angled sections 164 a , 164 b. [0035] For displaying merchandise packages 180 , the peg hook unit 145 is mounted to the pegboard 111 . Next, the packages 180 are mounted to the rods 118 a, 118 b, 118 c, 118 d of the peg hook unit 145 . The retainer member 160 is then mounted to the pegboard 111 below the peg hook unit 145 such that the retainer section 166 engages lower portions 186 of the front packages (i.e., those positioned at the front end of the display system 110 ) and such that the guide rods 140 a , 140 b , 140 c and the angled section 164 b engage associated lateral sides of the packages 180 . In this manner, the retainer section 166 inhibits the front packages and hence the remaining packages from tilting in an upward direction and thereby maintains the packages 180 in an upright (i.e., vertical) position. The guide rods 140 a , 140 b , 140 c and the angled section 164 b also inhibit the packages 180 from swinging (i.e., sticking) out laterally, thereby maintaining the packages 180 in a substantially linear fashion. [0036] It should be appreciated that the display system 110 provides numerous advantages over the prior art discussed above. For instance, the display system 110 shares many of the same advantages provided by the display system 10 shown in FIGS. 1 - 3 . Moreover, the reinforcing members 158 a , 158 b , 158 c , 158 d of the peg hook unit 145 provide additional support to the rods 118 a , 118 b , 118 c , 118 d , respectively, and hence inhibit the rods 118 a , 118 b , 118 c , 118 d from over-bending when packages are loaded thereon. [0037] It should also be noted that the display system 110 can have many modifications and variations. For instance, although four mounting hooks 114 a , 114 b , 114 c , 114 d are shown in FIGS. 6 and 7, the display system 110 can be provided with a different number of mounting hooks depending on available spaces, package sizes, etc. Moreover, the guide rods 140 a , 140 b , 140 c can be eliminated from the display system 110 . In addition, the peg hook unit 145 and/or the retainer member 160 can be treated with a suitable coating process (e.g. powder coating and zinc plating) for the purpose of providing them with a smooth slippery surface so as to enhance their appearance and/or functions (e.g. the packages 180 can slid easily on the peg hook unit 145 and/or the retainer member 160 ). [0038] [0038]FIG. 9 illustrates a merchandise display system 210 constructed in accordance with a third embodiment of the present invention. More particularly, the display system 210 includes a bracket 254 , which has a pair of prongs 216 , and a hook rod 218 , which is equipped with a leg portion 256 fixedly attached to the bracket 254 . A reinforcing member 258 is connected between the rod 218 and the leg 256 for providing additional support to the rod 218 and hence inhibiting same from over-bending when packages (not shown in FIG. 9) are loaded on the rod 218 . The display system 210 also includes a guide rod 240 having a leg section 241 , which is connected to the bracket 254 , a guide section 242 , which extends from the leg section 241 at an angle (e.g., a 90° angle), and a stop section 244 , which extends from the guide section 242 at an angle (e.g., a 90° angle). The guide section 242 is sized and shaped so as to engage associated lateral sides of the packages and to inhibit same from swinging out laterally. In this manner, the guide section 242 maintains the packages in a substantially linear fashion. Likewise, the stop section 244 is sized and shaped so as to engage the front package to maintain the packages in a substantially upright position. The display system 210 has a rigid construction. Alternatively, the display system 210 can be made such that the orientation of the guide rod 240 can be adjusted to accommodate packages having different sizes. [0039] [0039]FIG. 10 illustrates a merchandise display system 310 constructed in accordance with a fourth embodiment of the present invention. The display system 310 has a construction and operation identical to those of the display system 10 of FIGS. 1 - 3 , except as follows. The display system 310 includes a peg hook 314 which is provided with a peg rod 318 having a horizontal section 370 . The horizontal section 370 , which is preferably ¾ inch to 1 inch in length, is angled relative to the peg rod 318 such that when the peg hook 314 is properly mounted to a pegboard 311 , the horizontal section 370 assumes a substantially horizontal orientation. The display system 310 also includes a U-shaped support hook 324 which is provided with a support rod 330 having a horizontal section 331 . The horizontal section 331 of the support rod 330 has a length ranging preferably from ¾ inch to 1 inch. The horizontal section 331 is also angled relative to the support rod 330 such that when the support hook 324 is properly mounted to the pegboard 311 , the horizontal section 331 assumes a substantially horizontal orientation. Alternatively, the support rod 330 can have a construction identical to that of the support rod 30 of the display system 10 shown in FIGS. 1 - 3 (i.e., the support rod 330 can be linear throughout its length). [0040] Due to the horizontal section 370 of the peg rod 318 and/or the horizontal section 331 of the support rod 330 , less weight is exerted on packages 380 located at the horizontal sections 370 , 331 (i.e., at the front sections of the peg rod 318 and support rod 330 ) by packages located behind same. In this manner, the horizontal section 370 and/or the horizontal section 331 further assist the packages 380 to assume an upright position. In addition, the horizontal sections 370 , 331 cooperate to reduce friction between packages 380 located at the horizontal sections 370 , 331 , thereby facilitating the removal of the front package 3801 from the display system 310 . [0041] It should be noted that display system 310 can have numerous modifications and variations. For instance, the display system 310 can be used without the support hook 324 . In such circumstances, the diameter of the peg hook 318 can be increased to compensate for the lack of bottom support. The horizontal section 370 and/or the horizontal section 331 can also be modified such that they are angled upwardly from the peg rod 318 and the support rod 330 , respectively, when the peg hook 314 and the support hook 324 are mounted from the pegboard 311 . In this manner, the weight of the packages 380 located at the horizontal sections 370 , 331 can counteract with the weight of the packages 380 located behind same, further assisting the packages 380 to assume a proper orientation. This modification is particularly suitable when the display system 310 is used without the support hook 324 . [0042] It should also be noted that the horizontal section 370 of the peg rod 318 and/or horizontal section 331 of the support rod 330 can be incorporated into one or more of the embodiments of FIGS. 1 - 9 . For instance, a horizontal section can be provided in the mounting hooks 114 a , 114 b , 114 c , 114 d of the embodiment of FIGS. 6 - 8 and in the hook rod 218 of the embodiment of FIG. 9. [0043] FIGS. 11 - 13 illustrate a merchandise display system 410 constructed in accordance with a fifth embodiment of the present invention. For the sake of clarity, it is noted that FIG. 11 shows only one side of the display system 410 , the opposite side being a mirror image thereof. That is, the opposite side of the display system 410 has a construction basically identical to the side shown in FIG. 11. In such circumstances, the following discussion of the display system 410 will not include a discussion of the construction and operation of the opposite side. [0044] Referring to FIG. 11, the display system 410 includes a support frame assembly 470 having a plurality of rear vertical tubes 472 . The rear vertical tubes 472 extend in a vertical direction and are arranged linearly along a rear side of the display system 410 (i.e., in a lateral direction). Each of the rear vertical tubes 472 is provided with a plurality of U-shaped supporting bracket 474 securely attached (e.g., welded or bolted) thereto. Top and bottom horizontal tubes 476 extend between opposing lateral sides 478 (only one of which is shown in FIG. 11) of the display system 410 for securing the rear vertical tubes 472 thereto. Lateral top and bottom tubes 490 project in a direction transverse to the rear side of the display system 410 , while a front vertical tube 494 is connected to the lateral top and bottom tubes 490 . A top horizontal tube 477 extends from the front vertical tube 494 to a front vertical tube (not shown) located on the opposite lateral side of the display system 410 . Likewise, an intermediate horizontal tube 496 extends from the lateral bottom tube 490 to a lateral bottom tube (not shown) located on the opposite side of the display system 410 . A rack subassembly 498 extends between the lateral sides 478 of the display system 410 for supporting display boxes thereon (as indicated by broken line representation in FIG. 11). Each of the tubes 472 , 476 , 477 , 490 , 494 , 496 of the support frame assembly 470 discussed above is preferably made from a rigid material, such as steel, and has a square-shaped cross-section. Alternatively, the tubes 472 , 476 , 477 , 490 , 494 , 496 can be provided with different cross-sectional shapes. [0045] With reference to FIGS. 11 - 13 , the display system 410 is also provided with a horizontal support tube 497 which has a pair of ends 495 . The horizontal support tube 497 is preferably made from a rigid material, such as steel, and has a square-shaped cross-section. Alternatively, the horizontal support tube 497 can be provided with a different cross-sectional shape. Each of the ends 495 of the horizontal support tube 497 is sized and shaped so as to be removably received in a corresponding one of the U-shaped brackets 474 such that the horizontal support tube 497 can be securely mounted to the rear vertical tubes 472 . The horizontal support tube 497 is provided with a mounting rod 414 and a guide rod 434 . While additional mounting rods and guide rods are provided on the horizontal support tube 497 , because their construction and operation are identical to those of the mounting rod 414 and the guide rod 434 , respectively, they have been omitted from FIG. 11. [0046] Still referring to FIGS. 11 - 13 , the mounting rod 414 has a construction and operation basically identical to those of the peg hook 314 of the embodiment shown in FIG. 10, except as follows. The mounting rod 414 has an end 416 , which is received in the horizontal support tube 497 through a hole formed therein, and a section 418 extending from the end 416 . The section 418 of the mounting rod 414 is securely welded to the horizontal support tube 497 at a rear portion thereof 418 ′. The mounting rod 414 is also provided with a horizontal section 470 , which projects from the section 418 at an angle, and a tip 420 which projects from the horizontal section 470 at an angle. In this manner, when the horizontal support tube 497 is properly supported from the rear vertical tubes 472 , the section 418 extends in a generally downward direction, while the horizontal section 470 assumes a substantially horizontal orientation. [0047] The guide rod 434 has a construction and operation basically identical to those of the guide rod 240 of the embodiment shown in FIG. 9, except as follows. For instance, the guide rod 434 has an end 436 extending through and secured (e.g., welded or bolted) to the horizontal support tube 497 . A guide section 442 projects from the end 436 , while a stop section 444 projects from the guide section 442 . [0048] The display system 410 also includes horizontal support tubes 499 (see FIG. 11). More particularly, each of the horizontal support tubes 499 has a construction and operation identical to those of the horizontal support tube 497 . For instance, the horizontal support tubes 499 have mounting rods and guide rods (not shown) similar to the mounting rod 414 and the guide rod 434 . In such circumstances, a further discussion of the construction and operation of the horizontal support tubes 499 is considered unnecessary. [0049] It should be noted that the display system 410 can have numerous modifications and variations. For instance, the mounting rod 414 and the guide rod 434 can be attached to the horizontal support tube 497 by many different mechanisms. By way of example, the mounting rod 414 can be attached to the horizontal support tube 497 by a clip 493 bolted to same (see FIG. 14). The support frame assembly 470 can also be provided with different components or replaced with other supporting mechanisms. That is, the present invention can be used in connection with a wide range of support mechanisms, including wall systems, pegboards, support frames and other supporting systems. Moreover, the display system 410 can be provided with a support rod similar to the U-shaped support hook 324 of FIG. 10. [0050] It will be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention. All such variations and modifications, including those discussed above, are intended to be included within the scope of the invention as defined in the appended claims.

1a

REFERENCE TO RELATED APPLICATIONS This application claims priority to EP Application No. 07113705.3 filed Aug. 2, 2007, entitled DEVICE, SYSTEM AND METHOD FOR TARGETING AEROSOLIZED PARTICLES TO A SPECIFIC AREA OF THE LUNGS, and is incorporated herein by reference. FIELD OF THE INVENTION The present invention is directed to the administration of aerosolized particles to specific areas of the lungs, and in particular to the targeted delivery of aerosolized pharmaceutical formulations to specific areas of the lungs. More specifically, the present invention relates to devices and methods for depositing aerosolized particles to specific areas of the lungs by regulating aerosolization parameters of the device. The present invention also relates to devices, systems and methods for disease management, where the aerosolization parameters are adjusted based on monitoring at least one health parameter. BACKGROUND OF THE INVENTION Effective drug delivery to a patient is a critical aspect of any successful drug therapy. Of particular interest to the invention are pulmonary delivery techniques which rely on the inhalation of a pharmaceutical formulation by the patient so that a drug or active agent within the formulation can reach the lungs. Pulmonary delivery techniques can be advantageous for certain respiratory diseases in that it allows selective delivery of optimal concentrations of pharmaceutical formulations to the airways while causing less side effects than systematic administration. Nevertheless, many patients have experienced significant side effects caused by the necessary dosage for drugs commonly used in pulmonary delivery. Therefore, there is still a need to eliminate undesirable side effects, which in some case may include an increased risk for heart attack. For reducing these side effects, a pharmacologic approach has been taken. However, in some cases, the new found drugs are significantly more expensive thereby representing a major disadvantage to patients from poorer socioeconomic populations. Therefore, it would be advantageous to provide an alternative to the pharmacologic approach, whereby commonly used drugs can be delivered in an effective manner without the undesirable side effects. It has been found that the efficacy of drug delivery can be improved by targeting the aerosolized medication to certain areas of the lungs. Delivery and deposition of aerosols are determined by both the aerosol characteristics and by patient's breathing characteristics. Many existing inhalation devices can deliver aerosolized particles to the lungs, yet lack the ability to target the delivery to certain areas of the lungs. U.S. Pat. No. 5,906,202 describes a device and method for directing aerosolized mist to a specific area of the respiratory tract. By determining the particle size of the aerosols in combination with determining the volume of aerosol and aerosol free air allowed into the respiratory tract, it is possible for the described device to target a particular area of the respiratory tract. The device can allow the subject to inhale a predetermined volume of unaerosolized air followed by a predetermined volume of aerosol after which flow can be shut off completely or followed by additional aerosol free air. To this end, inspiratory flow rate measurements are made in order to determine a desired flow rate. The device then comprises a switch for releasing the predetermined volume of aerosol and aerosol free air at the desired flow rate. However, if the subject is unable to control their inspired flow rate to the set value, she/he will never receive the drug. This represents a disadvantage. It is also well known that the inspired flow can affect aerosol deposition independent of inspired volume. Since the described device requires that the subject breathe at a specific flow to trigger the aerosol, if the subject changes their flow immediately at the point of aerosol triggering, the deposition can be significantly altered, thereby representing another disadvantage. Further, there is still a need for a simpler device which enables lower costs for manufacture. SUMMARY OF THE INVENTION It is an object of the present invention to provide improved devices, methods and systems which overcome the various aforementioned drawbacks of the prior art. It is also an object of the present invention to provide a method and device for depositing aerosolized particles to specific areas of the lungs which enables effective treatment using lower doses of the drug. It is also an object of the present invention to provide a disease management system which enables the aerosolization parameters of the device to be adapted depending on measurement of at least one health parameter. For example, the measurement may be a spirometer for measuring a pulmonary function parameter indicative of the subject's inhalation or exhalation capacity. The monitor may also be a cardio-sensor for measure heart rate. The monitor may also be a glucose sensor for invasively or non-invasively measuring blood glucose levels. The present invention relates to novel methods and devices for targeting aerosolized particles, preferably aerosolized pharmaceutical formulations, to specific areas of the lungs. The pharmaceutical formulations that may be aerosolized include powdered medicaments, liquid solutions or suspensions and the like and may include an active agent. The inventors have found that effective targeting of aerosol particle deposition can be achieved by presetting certain aerosolization parameters of the device. The methods and devices of the present invention enable effective treatment to be maintained with notable reduction in the normally required amount of drug thereby possibly reducing or eliminating side effects. Targeting can be achieved by altering aerosol parameters, such as volume, particle size, timing and flow rate. As for timing, the present invention allows or introduces particle free air for a first predefined time period, then introduces a certain amount of aerosolized particles, also commonly referred to as an aerosol bolus, followed by a second predefined period of aerosol particle free air. The first predefined period of particle free air is optional, as the device can be adapted to activate the introduction of the aerosolized particles or aerosol bolus upon sensing the subject's inhalation. This might be desirable in cases where the aerosolized particles should be deposited to the lower regions (alveolar regions) of the lungs. The object of introducing particle free air in the first predefined period is to direct air to the lower regions of the lungs. This helps to support ventilation (removal of carbon dioxide). The volume capacity of the lower regions of the lungs will vary depending on the subject. The first time period could represent the amount of estimated time that it takes to fill the lower regions of the lungs. This time period is generally preset depending on the subject's data and can be adjusted depending on what best suits the subject. For targeting of bronchial areas within the lungs preferably, the first predefined time period of aerosol particle free air is set to be up to about 10 seconds. Most preferably, the first predefined time period of aerosol particle free air is up to 6 seconds, in particular 1 to 5 seconds, 2 to 4 seconds. Preferably, the first predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being up to 6 liters. Most preferably, the predefined volume of aerosol particle free air is about 0.1 to 3 liters, in particular 0.1 to 0.8 liters. For targeting of peripheral areas within the lungs, the first predefined time period of aerosol particle free air is set to be up to 3 seconds. Most preferably, the first predefined time period of aerosol particle free air is up to 0.2 seconds, in particular up to 0.06 seconds. Preferably, the first predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being up to 0.4 liters. Most preferably, the predefined volume of aerosol particle free air is up to 0.04 liters, in particular 0.01 liters. The device is adapted to administer a desired volume of aerosolized particles and can be adapted to administer the aerosolized particles within a predetermined time period. This volume is determined by the amount of pharmaceutical formulation that should be deposited in the lungs. Preferably, the predefined volume of aerosolized particles or aerosol bolus is set to be up to about 3000 ml. Most preferably, the pre-set volume of aerosolized particles is about 50 to 1300 ml. in particular 100 to 300 ml. The predefined volume of aerosolized particles can be introduced into the flow path for a preset time period. The loading dosage of pharmaceutical formulation to be aerosolized corresponding to the aerosol bolus can vary. Preferably, the amount of pharmaceutical formulation is less than 500 mg, most preferably about 1 to 600 μg, in particular about 10 to 300 μg. After release of the predefined volume of aerosolized particles, a volume of aerosol particle free air is introduced for a predefined time period. The object of this time period of particle free air is to clear the upper region and extrathoracic airway region, respectively, (e.g., mouth, pharynx, and trachea) of the lungs to thereby drive the aerosol bolus to the central region (bronchial) or peripheral region of the lungs. Preferably, this predefined time period of aerosol particle free air is set to be up to about 10 second. Most preferably, this time period of aerosol particle free air is about 0.2 to 8 seconds, in particular 0.3 to 2 seconds. Preferably, this predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being preferably up to 3 liters. Most preferably, this volume of aerosol particle free air is about 0.01 to 0.8 liters, in particular 0.05 to 0.3 liters. The length of the time periods can vary depending on which area of the lung is targeted for deposition. The present invention provides a device comprising a flow rate limiter or controller for limiting inhalation flow rate in a flow path to a preset flow rate range; and a timer to initiate, once a subject begins inhalation and has inhaled a first predefined time period of aerosol particle free air, a predefined volume of aerosolized particles to be introduced into the flow path, and to initiate after said predefined volume of aerosolized particles a second predefined time period of aerosol particle free air, such that the aerosolized particles are directed to the central airways of the lungs. The timer of the present invention serves to initiate the periods of aerosol particle and particle free flow. The timer can be in any form suitable in the field. Preferably, the timer is an electronic device which can be programmed or set with the predefined time periods. Preferably, the timer is adapted to indicate to the subject to stop inhaling after the subject has inhaled for the second predefined time period of aerosol particle free air or the device may further comprise an indicator to alert the subject to stop inhaling after the subject has inhaled for the second predefined time period of aerosol particle free air. The indicator may be an audible indicator that produces a tone or a visual indicator that flashes a light or changes color for alerting the subject. The flow limiter or controller of the present invention is for limiting or controlling inhalation flow rate in a flow path to be in a preset flow rate range. Preferably, the flow rate limiter is a discretely or continuously variable flow limiter or a controllable valve. Most preferably, the flow limiter has the features of the flow limiting device of U.S. Pat. No. 6,681,762, the control means of U.S. Pat. No. 6,571,791, or the controllable valve of US 2007/0006883 A1, the disclosures of which are incorporated herein by reference. In one embodiment of the flow limiter, the inspiratory flow is controlled by rigid and flexible walls that change cross sectional area as a function of the differential pressure across the orifices. For example, U.S. Pat. No. 6,681,762 describes a preferred embodiment of the flow limiter, wherein the flow passage is configured to have a flat elongate cross-section which is formed to have opposing large-area walls. This configuration enhances the inward bending of the walls for a reduction of the cross-section of the passage. The opposing walls are open on their outside, at least in the central area between the aspiration and inhalation orifices, to the environment, with each wall having preferably one chamber section on its outside, which is open via a bore to the environment, at least in the central area between the aspiration and inhalation orifices. With these structural provisions the required pressure equalization is ensured when the walls are contracted. In another embodiment, the flow limiter comprises a stratified structure for the flow passage, which comprises preferably a closed wall, a frame-shaped partition of the same size, and a wall of equal size with an aspiration and inhalation orifice, with the opposite walls being fastened on the sides of their edges in the housing. Any flexible and biologically tolerable material is suitable for configuring the flow passage, which material is flexible and can also be returned into its original shape after bending. It is preferred that at least the large-area passage walls, preferably also the partition, consist of silicone mats or foils whilst the housing is made of a preferably biologically tolerable material. In another embodiment of the flow limiter, the material layers of the flow passage are fastened for exchange between two housing sections. With such a structure, it is possible in a simple manner to use one flow limiter for different flow rate limiting parameters with a correspondingly associated flow passage. Each of the large-area passage walls has preferably the same thickness. In another embodiment of the flow limiter, provisions are made for a flow rate limitation independent of the environmental pressure, wherein each wall comprises on its outside a chamber section with a bore at least in the central area between the aspiration and inhalation orifices, which bores communicate with the aspiration orifice through a passage or a hose, respectively. With these provisions the differential pressure between the aspiration and inhalation orifices is measured, which is decisive for control, and flow rate limitation could also be operated in a closed system. According to a further embodiment of the flow limiter, the flow passage may have an annular cross-section, instead of a flat elongate cross-section, with the flow passage being preferably symmetrically disposed in a cylindrical housing at a spacing from the inside cylinder wall, between radial disks. These retainer disks are preferably provided with aspiration and inhalation orifices having the shape of ring segments, with the retainer disk having pressure equalizing bores for the cylindrical inside area and the annular zone surrounding the flow passage. This annular flow passage is preferably formed of silicone. In another embodiment of the flow limiter, provisions are made for the formation of the flow region between a central inhalation orifice and aspiration orifices radially surrounding them which region presents star-shaped or radial webs extending from a common bottom surface to the flexible wall and forming flow passages which can be restricted. With these provisions, the device can be designed with an extraordinarily compact structure that is easy to manufacture and to replace. The webs forming flow passages may have different lengths so that in the region of the longer webs a wider flow passage will be formed which then splits into several flow passages at intermediately arranged shorter webs. The cross-section of the webs may be constant in a radial direction. The webs flare outwardly over their width, with one aspiration orifice being preferably provided between two adjacent webs. In another embodiment, the flow limiter has a disk-shaped basic body wherein webs are integrally formed between flat recesses. Inhalation orifices are formed on the edge side in the recesses. The flow limiter has a thin flexible mat with a central aspiration orifice, which rests on the webs and is fastened in the edge region of the basic body. The mat may be adhesively fastened or welded, respectively, or clamped by means of an annular assembly element in the edge region of the basic body. The thin flexible mat is preferably made of silicone, silicone rubber, Viton, latex, natural rubber or any other elastomer. The flow limiter of the present invention may also be a control means as described in U.S. Pat. No. 6,571,791, wherein flow rate limiting is achieved by an adjustable channel height. In one embodiment, a flow channel is delimited preferably by two flexible walls arranged in parallel and spaced apart from each other, which, depending on the negative pressure, bends towards the inside and thus reduce the cross section of the channel, thereby limiting the flow. Other embodiments of the control means described in U.S. Pat. No. 6,571,791 are also suitable as flow limiters for the present invention and are enclosed herein by reference. The flow limiter of the present invention may also be a controllable valve as disclosed in US 2007/0006883. In one embodiment, the controllable valve comprise a housing, a membrane, an optional pressure plate, a closure element, a set piston and an adjusting screw, wherein the housing is essentially tubular and comprises a plurality of radially arranged webs, one web being longer than the others. On one side of the webs, the housing is designed so as to adjustably receive the set piston. On the opposite side so as to receive the membrane, the optional pressure plate and the closure element. The controllable valve allows for continuous or gradual flow control. Other embodiments of the controllable valve described in US 2007/0006883 are also suitable as flow limiters for the present invention and are enclosed herein by reference. In one embodiment of the present invention, the flow limiter is a control valve actuated by an inflatable balloon. In another embodiment of the present invention, the flow limiter is a piezo-controlled flow limiter, for example, comprising a flow channel having a height that is adjustable using a piezoelectric mechanism. Preferably, the device of the present invention comprises air control means responsive to the timer and adapted to seal the flow path after the subject has inhaled the second predefined time period of aerosol particle free air. Preferably, the air control means is an air shut off valve, air shut off channel, air control valve or the like. Preferably, the device comprises an air control valve for enabling a pre-settable volumetric flow of compressed air. Preferably, the air control means comprises a piezo-controlled valve, diaphragm-activated motor, solenoid, air piston and/or a mechanical valve operable with a timer. The device of the present invention preferably comprises a sensor in any suitable form for detecting when a subject is inhaling through the flow path. Preferably, the sensor comprises a pressure gauge responsive to suction pressure due to the subject's inhalation. In another embodiment, the sensor comprises a diaphragm responsive to sound waves caused by of the subject's inhaling. The diaphragm is preferably a microphone. In yet another embodiment, the sensor comprises a mechanical switch. In yet another embodiment, the sensor comprises a piezo membrane. Preferably, the sensor is placed at or within the inhaling channel of the device. The device of the present invention may be designed to receive a variety of detachable components, such as a mouthpiece, nebulizer or the like, and at least one cartridge or the like containing the pharmaceutical formulation. The device of the present invention may comprise a mouthpiece connected in fluid communication with the inhalation flow path. The mouthpiece may be a permanent part of the housing or a detachable part. Preferably, the device of the present invention comprises at least one orifice connectable to a source of aerosolized particles. The aerosolized particle source is preferably releasably or detachably connected to the device by any suitable means known in the art. The aerosolized particle source may be a powder dispersion device which utilizes a compressed gas to aerosolize a powder. The aerosolized particle source may be a nebulizer or the like, for aerosolizing solid or liquid particles. The nebulizer may be an ultrasonic nebulizer, a vibrating mesh nebulizer, a jet nebulizer or any other suitable nebulizer or vaporizer known in the field. These nebulizers can be separate components which can be attached to the device before use. The device of the present invention may also comprise a controller having a memory for storing a subject's individual parameters and/or aerosol depositing parameters. The timer of the present invention may be a component of the controller or a separate component connectable to the controller for receiving and/or sending information and/or data relating to the subject's aerosolization parameters. The device of the present invention may also comprise a reader for reading a memory means having a subject's individual parameters and/or aerosol depositing parameters stored thereon. The memory means can be in the form of any computer readable storage medium known in the art, such as but limited to a storage stick, memory disk or electronic data card, such as a smart card. The reader can be in any form as known in the art. For example, the reader can be an interface or port, e.g. a USB port or the like, for receiving a storage stick or a drive for receiving a memory or electronic data card. The device of the present invention may also comprise at least one communication means for receiving and/or sending data associated with a subject's individual parameters and/or aerosol depositing parameters. The communication means may be a wired connection or wireless connection sending and/receiving data via infrared, microwave or radio frequency, optical techniques or any suitable manner known in the art. The communication means may be a telephone connection or jack. This would be advantageous if a health provider, e.g. a doctor, would like to adjust the aerosol parameters from a remote location. For example, the first predefined time period, the second predefined time period, the predefined volume of aerosolized particles and/or the diameter size of the particle to be aerosolized could be adjusted remotely. The device of the present invention may also comprise at least one monitor for measuring a health parameter. The monitor may be a sensor or component, as known in the art, having suitable means for measuring a physiological factor. For example, the monitor may be a spirometer for measuring a pulmonary function parameter indicative of the subject's inhalation or exhalation capacity. The monitor may also be a cardio-sensor for measure heart rate. The monitor may also be a glucose sensor for invasively or non-invasively measuring blood glucose levels. The device of the present invention can be in any suitable form, such as a table-top device. Preferably, the device of the present invention is hand-held and portable. The present invention also relates to disease management methods and systems for monitoring and adapting the parameters for such targeting. The disease management system of the present invention provides at least the advantage of monitoring the health condition of the patient and being able to adjust the present device based on the subject's condition, thereby providing a more effective treatment in most cases. To this end, the system of the present invention comprises the device of the present invention and at least one monitor for measuring a health parameter, wherein the device is adaptable in response to measurements from one of said at least one monitor. The monitor may be any apparatus as known in the art for measuring a physiological factor. For example, the monitor may be a spirometer for measuring a pulmonary function parameter indicative of the subject's inhalation or exhalation capacity. The monitor may also be a cardio-sensor for measure heart rate. The monitor may also be a glucose sensor for invasively or non-invasively measuring blood glucose levels. The monitor may be a hand-held device. Preferably, the system comprises a base station having means for receiving and/or holding the device of the present invention and the at least one monitor. The receiving holding means can be a cradle. The base station preferably has a display for displaying any data and/or information. For example, the status or settings of the base station, device and/or monitor can be displayed. Preferably, the base station has control buttons for changing settings for the base station, device and/or monitor. The base station of the system also preferably has at least one communication means for receiving and/or sending data associated with a subject's individual parameters and/or aerosol depositing parameters and/or settings for the base station. The communication means may be a wired connection or wireless connection sending and/receiving data via infrared, microwave or radio frequency, optical techniques or any suitable manner known in the art. The present invention is also directed to methods for operating the aforedescribed devices and systems of the present invention. Further, the present invention is directed to a method of targeting aerosol particles to a specific area of the lungs comprising at least the steps of a) delivering a predefined volume of aerosolized particles to be inhaled into the flow path; and b) providing a predefined time period of aerosol particle free air into the lungs at a flow rate within the preset flow rate range to move the aerosolized particles to a targeted area of the lungs. For targeting aerosol particles to the central airways of the lungs, the method of the present invention may comprise a step before step a) of providing a first predefined time period of aerosol particle free air through a flow path into the lungs at a flow rate within a preset flow rate range. The method may further comprise a step of d) preventing flow through the flow path after providing the second predefined time period of aerosol particle free air. The method may further comprise a step of d) providing indication to the subject to stop inhaling after providing the second predefined time period of aerosol particle free air for the preset time period. Preferably, the method comprises a step of detecting when the subject is inhaling through the flow path. The method of the present invention may further comprise steps of measuring and adapting the first predefined time period, the second predefined time period and/or the predefined volume of aerosolized particles based on measurements of at least one health parameter. The present invention is also directed to a method for depositing aerosol particles to the central airways of the lungs comprising: a) providing a first predefined time period of aerosol particle free air through a flow path into the lungs at a flow rate within a preset flow rate range; b) delivering a predefined volume of aerosolized particles to be inhaled into the flow path; and c) providing a second predefined time period of aerosol particle free air into the lungs at a flow rate within the preset flow rate range to move the aerosolized particles out of the upper airway region. Preferably, the method further comprises d) preventing flow through the flow path after providing the second predefined time period of aerosol particle free air. Preferably, the method comprises d) providing indication to the subject to stop inhaling after providing the second predefined time period of aerosol particle free air for the preset time period. The method may also comprise detecting when the subject is inhaling through the flow path. Preferably, the flow rate is a predetermined fixed flow rate. Preferably, the first predefined time period of aerosol particle free air is up to about 10 seconds, the second predefined time period of aerosol particle free air is up to about 10 seconds and the predefined volume of aerosolized particles is up to about 3000 ml. Preferably, the first predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being up to about 6 liters. Preferably, the second predefined time period enables a predefined volume of aerosol particle free air, the predefined volume is up to about 3 liters. Preferably, the predefined volume of aerosolized particles is introduced into the flow path for a preset time period. Preferably, the method further comprises steps of measuring and adapting the first predefined time period, the second predefined time period and/or the predefined volume of aerosolized particles based on measurements of at least one health parameter. The term “pharmaceutical formulation” as used herein, includes active ingredients, drugs, medicaments, compounds, compositions, or mixtures of substances bringing about a pharmacological, often advantageous, effect. It includes food, food supplements, nutrients, medicaments, vaccines, vitamins, and other useful active ingredients. Moreover, the terms, as used herein, include any physiologically or pharmacologically active substances, bringing about a topical or systemic effect in a patient. The active ingredient lending itself to administration in the form of an aerosol can be an antibody, antiviral active ingredient, anti-epileptic, analgesic, anti-inflammatory active ingredient, and bronchodilator or can be an organic or inorganic compound, which without any restrictions can also be a medicament having an effect on the peripheral nervous system, adrenergic receptors, cholinergic receptors, skeletal muscles, cardiovascular system, unstriated muscles, circulatory system, neuronal connections, pulmonary system, respiratory system, endocrine and hormonic system, immune system, reproductive system, skeletal system, food supply system and excretory system, histamine cascade or central nervous system. Suitable active ingredients are for instance polysaccharides, steroids, hypnotics and sedatives, activators, tranquilizers, anticonvulsives (antispasmodics) and muscle35 relaxants, anti-Parkinson-substances, analgesics, anti-inflammatory agents, antimicrobial active ingredients, antimalarial agents, hormones, including contraceptives, symphatocomimetics, polypeptides and proteins producing physiological effects, diuretics, substances regulating the lipometabolism, anti-androgenic active ingredients, antiparasitics, neoplastic and antineoplastic agents, antidiabetics, food and food supplements, growth-promoters, fats, stool-regulators, electrolytes, vaccines and diagnostics. The invention is particularly suited for inhalation application of different active ingredients, such as the following ones (without being restricted thereto): Insulin, calcitonin, erythropoietin (EPO), factor VII, factor IX, cylcosporin, granulozyte colony stimulating factor (GCSF), alpha-1-proteinase inhibitor, elcatonin, granulocyte macrophage colony stimulating factor (GMCSF), growth hormones, human growth hormone (HGH), growth hormone releasing hormone (GHRH), heparin, low molecular weight heparin (LMWH), interferon alpha, interferon beta, interferon gamma, interleukin-2, luteinizing hormone releasing hormone (LHRH), somatostatin, somatostatin-analogs, including octreotides, vasopressin analogs, follicle stimulating hormone (FSH), insulin-like growth factor, insulintropin, interleukin-I receptor antagonist, interleukin-3, interleukin-4, interleukin-6, macrophage colony stimulating factor (M-CSF), nerve growth factor, parathryoid hormone (PTH), thymosin alpha 1, IIb/IIIa inhibitor, alpha-1 antitrypsin, antibodies against respiratorily syncytic virus, cystic fibrosis transmembrane regulator gene (CFTR), desoxyribonuclease (Dnase), bactericides, permeability increasing protein (BPI), anti-CMV antibodies, interleukin-1-receptor, retinol, retinyl-ester, tocopherols and their esters, tocotrienols and their esters, carotinoids, in particular beta carotin and other natural and synthetic antioxidants, retinol acids, pentamides, albuterolsulfate, metaproterenolsulfate, beclomethasonedipropionate, triamcinolonacetamide, budesonidacetonides, ipratropium bromide, salbutamols, formanilides, flunisolides, fluticasones, cromolyn potassium, ergotamine tartrate and the analogs, agonists and antagonists of the above-mentioned substances. Moreover, active ingredients can be nucleic acids in the form of pure nucleic acid molecules, viral vectors, associated viral particles, nucleic acids associated with or contained in lipids or a lipid containing material, plasmid DNA or plasmid RNA or other constructs from nucleic acids, which are suitable for cell transfection or cell transformation, in particular in the case of cells of the alveolar region of the lung. The active ingredient can be present in different forms, such as soluble or insoluble, charged or uncharged molecules, components of molecular complexes or pharmacologically acceptable inactive ingredients. The active ingredient can consist of naturally occurring molecules or their recombinant products, or the molecules can be analogs of the naturally occurring or recombinantly produced active ingredients to which or from which one or more amino acids have been added or deleted. Moreover, the active ingredient can contain attenuated live vaccines or killed viruses for vaccination purposes. If the active ingredient is insulin, it includes naturally extracted human insulin, recombinant human insulin, insulin extracted from cattle and/or swine, recombinant porcine or bovine insulin and mixtures of the above-mentioned insulins. The insulin can be present in a substantially purified form, but can also contain usual commercial extracts. The term “insulin” also includes analogs, to which or from which one or more amino acids of the naturally occurring or recombinant insulin have been added or deleted. BRIEF DESCRIPTION OF THE DRAWINGS Some embodiments of the invention will be described with reference to the figures: FIG. 1 is a perspective view of an embodiment of a system according to the present invention. FIG. 2 is a front view of the system shown in FIG. 1 . FIG. 3 is an exploded view of components of the system shown in FIG. 1 . FIG. 4 is a top view of the system shown in FIG. 1 . FIG. 5 is a perspective view of another embodiment of a system according to the present invention. FIG. 6 is a front view of the system shown in FIG. 5 . FIG. 7 is an exploded view of components of the system shown in FIG. 5 . FIG. 8 is a top view of the system shown in FIG. 5 . FIG. 9 is a graph of measurements of forced expiratory volume versus time from experimental data comparing the present invention with prior art device and method. FIG. 10 is a graph of measurements of heart rate versus time form experimental data comparing the present invention and a prior art device and methods. FIG. 11 is a cross sectional view of the device illustrated in FIGS. 1-4 . FIG. 12 is a graphical illustration of the functional features of the device illustrated in FIGS. 1-4 . DESCRIPTION OF THE PREFERRED EMBODIMENT In FIGS. 1 to 4 , one embodiment of a system according to the present invention is illustrated. In this embodiment, system A comprises a device 10 according to the invention, a monitor 20 for measuring a health parameter and a base station 30 for receiving the device 10 and/or monitor 20 . As depicted, the device 10 can be hand-held, portable device. The device 10 has a housing with a mouthpiece 11 . The mouthpiece 11 may be removed or replaced by a compatible mouthpiece. To this end, a connection is provided in the housing of device 10 for enabling a detachable connection with the mouthpiece 11 . Alternatively, mouthpiece 11 may be an integral part of the housing of the device 10 . Device 10 is also adapted to receive a cartridge or receptacle 40 holding the pharmaceutical formulation or drug. For example, the housing of device 10 can be manufactured such that cartridge 40 can simply be inserted into the top of the device as shown in FIG. 3 . The monitor 20 can also be a hand-held, portable device as shown. Monitor 20 may also have control buttons for controlling the operations of the monitor and/or a display for showing measured results and/or settings. Monitor 20 can be a spirometer for measuring a lung function parameter, for example the inhalation or the exhalation capacity of the subject. The base station 30 includes cradles 32 , or the like, for holding the device 10 and monitor 20 . The base station 30 may also serve as a charger for recharging any batteries provided in device 10 and/or monitor 20 . To this end, cradles 32 may include an interface enabling an electronic connection with device 10 or monitor 20 . The interface could also enable the transfer of data between the base station 30 and the device 10 or monitor 20 . As depicted, base station 30 may also have a display 31 for displaying any desired information or data, for example the status of the base station 30 , device 10 and/or monitor 20 . Base station 30 may optionally include a slot 34 for receiving a memory card, e.g. a smart card, having data with the subject's aerosol parameters. In this respect, multiple users could use the base station 30 for adapting their inhalation devices 10 . Base station 30 may also include an additional reader for reading a storage medium like a memory stick. Although not shown, base station 30 may include communication means for enabling wired or wireless telecommunication and/or data transfer to and from a remote location. The display 31 can optionally include a timer 35 to indicate when to inhale and exhale and a communication means 36 . FIGS. 5 to 8 show an alternative embodiment of the system of the present invention. In this embodiment, system B comprises a device 100 according to the invention and a base station 300 for receiving device 100 . The device 100 and base station 300 can have the same features as device 10 and base station 30 respectively. Different from device 10 , device 100 also comprises a monitor or monitoring means and can function as both inhalation device and health parameter monitor. For example, device 100 can be an integrated inhalation device and spirometer as shown in FIGS. 5 to 8 . As shown in FIG. 7 , device 100 can also be configured to receive at least one drug cartridge 40 . In FIGS. 1 to 8 , exemplary systems are shown for respiratory disease management (RDM). However, modifications of the present system are possible for other types of disease management. Also, variations of illustrated systems A and B are possible. For example, the base station 30 of system A may be used for receiving device 100 having an integrated spirometer and an additional monitor for measuring a health parameter such as a cardio-monitor measuring heart beat rate for example. An experiment was performed to test the effectiveness of targeting aerosolized particles to specific areas of the lungs using the methods and devices of the present invention. The experiment was made using albuterol, a drug commonly used to treat asthma as an aerosol. Although commonly used in the field of asthma treatment, many patients have reported several undesirable side effects including palpitations, tremors and nervousness. It has been found in the field that the side effects of albuterol are directly related to the dose delivered and absorbed in the blood stream. FIG. 11 illustrates a cross sectional view of a device 10 and mouthpiece 11 taken along cross section line A-A and illustrates the flow pathway 42 from the pharmaceutical formulation or drug cartridge 40 to the flow rate limiter 400 and then to the mouth piece 11 . FIG. 12 illustrates the functional features that are included in the device 10 and which may or may not include alternative specific structural embodiments as set below. Device 10 includes a flow rate limiter 400 . Flow rate limiter 400 is connected to the pharmaceutical formulation or drug cartridge 40 and to the mouth piece 11 via flow pathway 42 . Timer 410 controls the flow rate limiter to initiate, once a subject begins inhalation and has inhaled a first predefined time period of aerosol particle free air, a predefined volume of aerosolized particles to be introduced into the flow path, and to initiate after said predefined volume of aerosolized particles a second predefined time period of aerosol particle free air, such that the aerosolized particles are directed to bronchial and/or peripheral airways of the lungs. Device 10 may also include an air control valve 420 is connected to the source of particle free air via particle free air pathway 44 . Air control value 420 is typically controlled by the timer may include a piezo-controlled valve, diaphragm-activated motor, solenoid, air piston or a mechanical valve a mechanical switch. Device 10 may also include a sensor 430 for detecting when a subject is inhaling through the flow path. Sensor 430 is also typically, connected to the timer and may include a pressure gauge responsive to suction pressure due to the subject's inhalation, a diaphragm responsive to audible intensity of the inhalation flow rate, said diaphragm preferably being a microphone, mechanical switch or a piezo membrane. As indication of the degree of bronchodilation, a spirometer was used to measure the forced expiratory volume per sec (FEV1) at several points in time. As an indication of the side effects of the drug, the heart rate of the subject was measured. Tremor effects were measured by a finger accelerometer. For the experiment, a nebulizer was used. The nebulizer was built around a small vibrating disk that has 4,000 laser precision drilled holes in it. The disk was vibrated on the surface of the Albuterol at more than 100,000 times per second. This pulled the liquid through the holes to form droplets of precise uniform size. In the experiment, data was measured for five different cases; A, B, C, D and E, each having different aerosol parameters: In Case A, a conventional device and method were used, and no targeting of the aerosolized particles was performed. A 2500 μg albuterol formulation was nebulized, which represents approximately the typical adult dose used in conventional nebulizers for achieving maximal bronchodialation. In Cases B, C, D and E, the device and methods of the present invention were used. In Case B, the aerosolized particles were targeted to the large airways of the lungs using a 6-micron diameter particle size and 104 μg albuterol loaded into the device with 50 μg deposited. In Case C, the aerosolized particles were targeted to the large and small airways of the lungs using a 3.5-micron diameter particle size and 188 μg albuterol loaded into the device with 50 μg deposited. In Case D, the aerosolized particles were targeted to the alveolar airways of the lungs using a 3.5-micron diameter particle size and 98 μg albuterol loaded into the device with 50 μg deposited. In Case E, the aerosolized particles were targeted to the large and small airways of the lungs using a 3.5-micron diameter particle size and 282 μg albuterol loaded into the device with 75 μg deposited. Referring to FIGS. 9 and 10 , the experimental results of the measured FEV1 and heart rate over a period of time are depicted for Cases A, B, C, D and E. Although Case A exhibited a maximal bronchodilation, the heart rate significantly increased thereby representing a heart attack risk for the subject. Case B resulted in a notable bronchodilation, yet significantly less than the degree of bronchodilation achieved with Case A. However, in contrast to Case A, the heart rate remained stabile. With Case C, a very good bronchodilation was achieved, which was approximately equivalent to that of Case A. In contrast to Case A, the heart rate remained stabile. Also, a significantly lower amount of albuterol was sufficient for achieving similar degree of bronchodilation as that of Case A. In Case D, the same amount of albuterol was used as Case C. However, the lower region (alveolar) of the lungs was targeted. The degree of bronchodilation was significantly lesser than that of Case A. However, in contrast to Case A, the heart rate remained stabile. For Case E, the large and small airways were targeted as in Case C. However, the deposited dose of albuterol was increased by 50 percent to 75 μg. Case E resulted in very good bronchodilation with FEV1 measurements being almost equivalent to those of Case A. However, in contrast to Case A, the heart rate remained stabile. Also, as can be seen in FIGS. 9 and 10 , Cases C and E had the same duration of effect as Case A. Cases B, C, D and E lead to less tremor effects as Case A. Hence, the experimental data suggest that, using significantly less than the normal dose, the present invention provides equivalent bronchodilation, equivalent duration of effect and induces less cardiac stimulation and tremor effects In particular, the experimental results show that the efficacy of a pharmaceutical formulation can be notably increased, without involving a significantly increase in dose amounts and side effects, by targeting the aerosolized formulation to certain areas of the lungs using the device of the present invention. This provides valuable advantages for the subject, especially in terms of reducing possible health risks associated with various pharmaceutical formulations. Subjects would benefit by needing only a small percentage of the typical drug dose to attain the same therapeutic effects. The various embodiments and experimental results presented in the specification are used for the sake of description and clarification of the invention, and thus should not be interpreted as limiting the scope of the invention as such. Moreover, the present invention is realized by the features of the claims and any obvious modifications thereof. LIST OF REFERENCE NUMERALS A System 10 device 1 mouthpiece of device 20 spirometer 30 base station 31 display 32 cradle 34 slot for reader 35 timer 36 communication means 40 drug cartridge 42 flow pathway 44 particle free air pathway B System 100 device 110 mouthpiece of device 300 base station 310 display 320 cradle Device Features 400 flow rate limiter 410 timer 420 air control valve 430 sensor

1a

RELATED APPLICATIONS [0001] This application claims priority to U.S. Non-Provisional application Ser. No. 10/425,316, filed Apr. 29, 2003, the entire contents of which are hereby incorporated by reference herein. FIELD OF INVENTION [0002] The invention relates to the field of medicine. More particularly, this invention relates to garments for providing access and support to central line catheters for safety, maintenance, comfort, and decreased exposure of an implantation site. BACKGROUND [0003] A central line catheter is a surgically implanted line having one end threaded into a vein. The other end, which remains outside the body, provides access for administering medication, performing blood transfusions and intravenous infusions and taking blood for tests. Catheters may remain in place for a varied length of time and possibly permanently. A small cuff around the central line is typically located under the skin just above the exit or port site. Scar tissue under the skin eventually grows around the cuff to hold the line in place. Until this happens a stitch may hold the line in place. A bandage may also be used as a temporary or daily dressing to protect the port site from infection, damage to the site, and premature or accidental removal of the catheter. A port (i.e., access port) at the end of the external portion of the catheter line enables access for injections and desired procedures. A catheter may contain a plurality of lines (lumens) where multiple fluids will be infused. In such case, an access port is provided at the end of each lumen. [0004] It is important to secure the port or line site in patients with central lines. These sites require daily maintenance for the proper functioning of the catheter. Doctors have generally used gauze pads, various forms of adhesives, plastic shields, and garments, such as jog bras, to secure the catheter to the patient. Without such security, the patient runs the risk of infection, snagging of the line and causing damage and/or accidental or unintentional removal of the line prematurely, and increased scarring due to the movement of the catheter. It is especially important during the first few weeks after the implantation of the catheter that it be held securely to the body of the patient to allow for the scar tissue to form on the catheter cuff which ensures long term security and use of the catheter device. [0005] Although during the day many women can use bras and men can use necklaces with clamps to hold the catheter in place, comfort and safety during sleeping has continually posed problems. Necklaces tend to shift with the patient during the night, and wearing a bra at night is not comfortable. Neither of these options offers any security to the port site or external catheter lines when in a reclined mode, such as sleeping, thus posing a threat to damaging the site, premature or accidental removal of the catheter, and discomfort from rolling over onto the ends (i.e., access ports) of the external lines. [0006] Patients have been encouraged to purchase sports bras and other women's accessories as a method for keeping the catheter line secure and the site protected. The negatives of these alternatives are many. For example, a large male will not find even the largest sports bra comfortable. A female, with a sports bra fitted to her size, can also find these very uncomfortable as they cross over the neck area in a sensitive place where the internal catheter is close to the skin. Sports bras are extremely tight against the body as a whole. The sports bra design, although very secure, often crosses over the clavicular area of the patient, the site where most central lines cross into the neck. This not only causes discomfort around the mid-section of the patient, but also in the neck area which is often affected by the central line placement. A sports bra is also very difficult to take on and off. This would even be more difficult for a patient with limited range of upper body motion or upper body weakness. [0007] T-shirts, a few sizes too small, are also used to keep the line tight against the body of the patient and the dressing on the implantation site secure. However, as with sports bras, getting these garments on and off can be difficult for patients with a limited range of upper body motion. Such garments also do not facilitate access to the implant area or the lines themselves. Furthermore, standard t-shirts lack a containment and support means for keeping the external catheter lines above the midsection. Thus, increased tension can be placed on the port site due to the lack of support for the weight of the external lines. [0008] Shoulder straps, spaghetti straps, or thinner shoulder pieces have the disadvantage of either not covering the port site or irritating the port site by either rubbing it or getting under the bandage designed to protect the site. If the port site is located centrally on the patient's chest, these types of garments might not even cover the port site thus serving no purpose other than holding the external catheter lines above the midsection. [0009] Other garments addressing this issue have been designed to assist in the external care of the catheter lines. For example, Intravenous Catheter Holder , Schneider, U.S. Pat. No. 4,578,062 (Mar. 25, 1986), describes a pouch to contain the catheter and access through the shoulders for maintaining the site. Another example, Garment for Concealing Patient Medical Appliances , Ojoyeyi, U.S. Pat. No. 6,477,710 B1 (Nov. 12, 2002) describes several pockets to hold catheter lines, however, it does not offer the easy shoulder access as the garment described in U.S. Pat. No. 4,578,062 (Mar. 25, 1986). The pouch and pocket both offer an area to store the line versus having it hang free or attached to clothing or a necklace by a clip. However, there is no option as to the placement of the pouch or pocket and, thus, this can be uncomfortable to some patients. The clips can be cold and hard, the necklaces can hang around the sensitive areas of the neck. The pouches and pockets do not offer any options in the placement of the lines against the body, therefore causing discomfort when hard clamps and access ports are pressed against the body. [0010] Thus, an improved garment is needed to secure the line and implantation site, provide comfort to the patient, accessibility to medical staff, ease in cleaning the port site, and ease in putting on and taking off the garment. SUMMARY [0011] A garment in accordance with an exemplary embodiment of the present invention includes an inner layer of fabric relatively tightly fitted to the body to secure the dressing to a port site. The garment includes an inner shelf lining of elastic to allow the patient flexibility in locating the end(s) of the catheter in the garment, but keeping the end(s) from falling low enough to pull at the implantation site. In a preferred embodiment, an outer layer is attached to the inner layer, such as at the shoulders, arms and neck, to provide comfort and to reduce stress on the inner layer, lines and port site from movement of outer garments. Also in a preferred embodiment, releasable closures are provided at the shoulders to enable access for easy cleaning, treatment procedures, and putting on and taking off the garment. The neck is preferably high enough to protect any port site a doctor may choose when inserting a catheter into the patient, but low enough not to press on the clavicular area. The inner garment and elastic band are preferably tight enough to secure the port site, dressing, and lines, but also provide the patient with options of locating the end(s) of the catheter line where it is most comfortable for that patient. [0012] It is, therefore, an object of the present invention to provide a garment that will secure central catheter lines or other similar devices, including the external portion of lines and port sites. [0013] It is another object of the present invention to provide a garment that facilitates access by medical staff and care givers for cleaning and treating, and placing on and removing the garment, especially for patients with limited range of upper body motion. [0014] It is also another object of the present invention to provide a garment that allows a patient to choose where a catheter line is held against the body. [0015] It is yet another object of the present invention to provide a garment that accommodates a range of port sites, thereby enhancing doctors' flexibility in site selection. [0016] It is another object of the present invention to provide a garment that is comfortable to a patient in a reclined position, such as sleeping, and enables the patient to change positions while reclined without damaging the catheter, prematurely or accidentally removing it, or incurring discomfort. For example, patients can comfortably sleep in any position. [0017] It is a further object of the present invention to provide a garment that protects catheter lines and a port site while providing security of the line and comfort to the patient. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The foregoing and other objects, features and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings where: [0019] [0019]FIG. 1 conceptually depicts the front of an outer layer of a garment in accordance with an exemplary embodiment of the present invention. The outer layer is designed as a sleeveless t-shirt with releasable closures at the shoulders. The closures are preferably adjustable to allow for a customized fit of the patient. The length is preferably long enough to tuck into pants, skirts, pajama bottoms, shorts, or any other lower body garment. [0020] [0020]FIG. 2 conceptually depicts the back of an outer layer of the garment in accordance with an exemplary embodiment of the present invention. The outer layer design is the same as in FIG. 1. [0021] [0021]FIG. 3 conceptually illustrates the front of an inner layer of a garment in accordance with an exemplary embodiment of the present invention. The inner layer is preferably secured to the outer layer at the neck, shoulder and arm seams. The shoulder seams are preferably adjustable for a customized fit. The material is a relatively tight, stretchable fabric, tighter in fit than the outer layer, providing security to the port site. An elastic body band is attached to the inner layer and sits low enough on the patient for comfort yet high enough to inhibit the catheter lines from falling downward and pulling on the port site. [0022] [0022]FIG. 4 conceptually illustrates the back of an inner layer of the garment in accordance with an exemplary embodiment of the present invention. [0023] [0023]FIG. 5 conceptually illustrates the front of a garment in accordance with an exemplary embodiment of the present invention along with a variety of possible placements (each denoted with an X), but not limited to these shown, for a catheter port, demonstrating versatility of the garment. The garment is low enough not to interfere with clavicular areas, yet high enough to provide security to a wide variety of port sites. [0024] [0024]FIG. 6 conceptually illustrates the front of a garment in accordance with an exemplary embodiment of the present invention along with various positions of a catheter line (each position being represented by a curved line ending with an arrow) to provide comfort to a patient. A garment in accordance with the present invention permits a patient to place the lines under an arm, between breasts, or along the chest area, or to separate them to avoid rubbing, pressure points, and discomfort. [0025] [0025]FIG. 7 conceptually illustrates releasable closures for the shoulder regions of an outer layer of a garment in accordance with an exemplary embodiment of the present invention. [0026] [0026]FIGS. 8, 8A and 8 B conceptually illustrate dimensions for standard sizes of an inner layer and an outer layer of a garment in accordance with an exemplary embodiment of the present invention. [0027] [0027]FIGS. 9 and 10 illustrate a sports bra and garment with spaghetti straps and particular areas of conflict or discomfort with a catheter port or line. DETAILED DESCRIPTION [0028] Referring now to FIG. 1, a front view of an outer layer 100 of a central line access and support garment in accordance with an exemplary embodiment of the present invention is shown. The outer layer 100 comprised of material such as cotton, a stretchable synthetic fiber material (e.g., Lycra® by E. I. du Pont de Nemours and Company), jersey knit, or other fabric, provides an undershirt garment for appearance. It also protects an inner layer (discussed below) by reducing or eliminating frictional motion from movement of outer clothing worn by a patient. The outer layer 100 preferably has a neck line 105 just below the patient's clavicular region 110 to avoid contact with a catheter line which may cross into the neck region. The shoulders 115 and 120 of the outer layer 100 are preferably broad enough to provide security without being uncomfortably tight. [0029] The outer layer 100 is preferably comprised of a front panel and a back panel, discussed below, as in a conventional manner for shirts. The front panel and back panel may be joined by stitching along sides 150 and 155 in a conventional manner. [0030] Left and right shoulder portions or sections ( 115 and 120 , respectively), each having front panel and back panel portions (or sections), are provided. The shoulder portions 115 and 120 of the front panel are preferably releasably joined to the shoulder portions of the back panel using releasable closure means, such as hook and loop fasteners (e.g., Velcro® hook and loop fasteners by Velcro Industries B.V.); though other releasable closure means (e.g., buttons, snaps and zippers) may be used without departing from the scope of the present invention. In an exemplary embodiment, snag free releasable closures such as Snag-Free Velcro® fasteners with buffers are used to eliminate snagging of adjacent fabrics and to resist lint build-up. The releasable closure means may allow adjustment of the shoulder portions to accommodate a range of patient physiques and preferences. By way of example and not limitation, the shoulder portions 115 and 120 of the front panel of the outer layer may have loop portions of a hook and loop closure 705 and 710 , as shown in FIG. 7, horizontally across the width of the shoulder seams 115 and 120 . The back panel may have cooperating hook portions of hook and loop closures 715 , 720 , 725 , 730 vertically along the sides of the shoulder strap to allow for customized adjustment. [0031] In use, a patient may open the releasable closures 715 - 730 at the shoulder sections to facilitate removing and placing on the garment. Additionally, a patient may open the releasable closures for one or both shoulders to facilitate access to the catheter line and/or port site. [0032] The outer garment preferably provides arm holes 135 and 140 large enough to comfortably accommodate a patient's arms, but small enough to provide security for the catheter. Adjustment of the releasable closure means 715 - 730 , preferably adjusts the sizes of the arm holes, allowing the garment to accommodate various physiques and preferences. [0033] The outer layer 100 is joined to the inner layer 300 shown in FIG. 3, along the arm holes 135 and 140 , the shoulders 115 and 120 , and the neckline 105 as indicated by the dotted line 160 . The inner layer 300 is shorter in length than the outer layer 100 as indicated by the dotted line 170 . [0034] In FIG. 2, a rear view of the outer layer 100 of the central line access and support garment in accordance with an exemplary embodiment of the present invention is shown. The outer layer 100 remains the same as described in FIG. 1. The neckline 205 is closer to the base of the neck of the patient to provide enhanced fit, comfort, and security. Arm holes 135 and 140 remain the same as described in FIG. 1. The shoulder closures 115 and 120 remain the same as described in FIG. 1, and the inner layer 300 is joined to the outer layer 100 as indicated by the dotted line 260 . The front panel and the back panel may be joined by stitching along sides 150 and 155 in a conventional manner. The inner layer 300 is shorter in length than the outer layer 100 as indicated by the dotted line 170 . [0035] The inner layer 300 of a garment, as shown in FIGS. 3 and 4, in accordance with an exemplary embodiment of the present invention is of a similar shirt design as the outer layer. However, the inner layer is preferably smaller in width below the arm holes to allow for a relatively tight fit against the body and shorter in length, so as to be concealed by the outer layer. The material of the inner layer is preferably a stretchable fabric (e.g., Lycra® by E. I. Du Pont de Nemours and Company), a tight jersey knit, a polyester stretch, a cotton, a blend of the above fabrics, or other suitable fabrics. The material should be chosen with patient comfort in mind, especially for patients with sensitive skin. The inner layer may otherwise follow the same general shirt pattern as the outer layer. [0036] In a preferred embodiment the inner layer 300 is attached to the inside of the outer layer 100 . For example, the neckline 305 of the inner layer may be stitched to the neckline 105 of the outer layer. Shoulder seams for a front panel of the inner layer 310 and 315 may be attached to shoulder seams for a front panel of the outer layer 115 and 120 . Likewise, shoulder seams for a rear panel of the inner layer may be attached to shoulder seams for a rear panel of the outer layer. Preferably, upon opening releasable closure means 715 - 730 provided at the shoulders of the outer layer, the shoulders of the outer layer and the shoulders of the inner layer may be opened. Thus, in an exemplary embodiment, the releasable closure means for the outer layer operate as releasable shoulder closure means for the inner layer. [0037] The sides 320 and 325 of the inner layer 300 are joined from the arm holes to the bottom hem 330 in a conventional manner, but independently from the outer layer 100 and sides 150 and 155 . [0038] A bottom hem 330 for the inner layer 300 is preferably comprised of an elastic band. For example, a ¾-1″ inch width band may be used, though narrower or wider elastic can also be used. Lingerie or cotton elastic is preferred for comfort. The elastic is preferably smaller than the chest dimension for the size of the garment. For example; a woman's large may measure thirty inches at the chest and twenty-seven inches at the bottom hem. Preferably, the elastic band provides a comfortable but secure fit to prevent the free ends of the catheter lines from falling below the hem under normal conditions, while protecting the catheter port site and lines. [0039] [0039]FIG. 4 demonstrates the rear panel of the inner layer 300 . As described in FIG. 3, the rear panel of the inner layer 300 remains the same with the exception that neckline 405 has been raised to the same level as the outer layer neckline 205 and is stitched in the same manner as 105 and 305 of the front panels. [0040] Referring now to FIG. 5, various potential port sites are conceptually illustrated, although not limited to, each by an X. A garment in accordance with an exemplary embodiment of the present invention conceals, and therefore secures, port sites within the boundaries of the garment. Thus, the garment accommodates a wide range of port sites. It does not have openings or pockets that require certain specific port site locations. [0041] Referring now to FIG. 6, various locations and positioning of the external line portion of a catheter are conceptually illustrated, each by a curved line with an arrow. The external portion of each line starts at a port site 605 and ends with an access port (denoted by an arrow). Though lines with a plurality of lumens or single lumen may be used, double lumen lines are conceptually shown in FIG. 6 to illustrate a range of placements for a given port site. For clarification, lumens 610 and 625 stem from the same catheter line, as do 615 and 620 , 630 and 635 , 640 and 645 , and 650 and 655 . Clips, which are commonly used with lines/lumens, are also not shown in FIG. 6. Of course, the port site shown in FIG. 6 is but one example of a port site. Other port sites within the boundaries of the garment may be used without adversely reducing the efficacy of the garment. [0042] A garment in accordance with an exemplary embodiment of the present invention conceals and secures lines in a wide range of positions, as demonstrated but not limited to, 610 - 655 within the boundaries of the garment. Thus, the garment allows positioning of a line to maximize comfort. By way of example, a patient wishing to sleep on his or her side or stomach may position the line (and particularly the access ports and any clips, both of which can be hard), in a location that enhances comfort. Advantageously, the garment does not depend upon immovable openings or pockets for locating the line. [0043] According to an exemplary embodiment of the invention the inner layer is used with an outer layer. Advantageously, the outer layer helps insulate the inner layer from stresses and strains attributed to movement of a patient's outer clothing. Without an outer layer, movement of outer clothing could possibly cause the inner layer to move against the patient's body and thus cause complications with the port site and catheter lines. The outer layer is designed to reduce that risk allowing the inner layer to do what it is designed to do—protect and secure the port site and line. As described above, the outer layer may be joined to the inner layer at the neckline, but not at the bottom (waist) of the garment. Thus, the bottom of the outer layer may shift independent of the inner layer. Such independence, prevents snagging of the outer garment from imparting stresses to the central line protected by the inner layer. This attachment arrangement of an independently movable outer layer which is not attached to the inner layer at the bottom thus provides an important advantage over conventional single layer garments and garments with separate layers attached at the bottom and top. [0044] Another important aspect of the invention is that the inner layer provides compressive support adequate to comfortably secure lines in a wide range of positions, without exerting excessive compressive pressure. In other words, the support provided by the inner layer of a properly sized garment according to the invention is adequate to secure a wide array of catheter lines and lumens against the wearer's body in a wide variety of positions, without causing discomfort from excessive compression. Preferably, the compressive support provided by a properly sized inner layer is substantially uniform, such that the force exerted against a catheter line at one position is substantially similar to the force exerted at another position (i.e., within the tightness range as described below). [0045] In a preferred implementation, the magnitude of the compressive force provided by a properly sized garment according to an embodiment of the invention is within a tightness range, which is referred to herein as an effective tightness or an effectively tight fit. At the lower end of the range is a compressive force adequate to hold a line against a wearer's body. At the higher end of the range is a compressive force that is a few times (e.g., two to three times) the compressive force at the lower end of the range. Below the lower end of the range, the inner layer would provide inadequate compression to secure a line against a wearer's body. Any fit that does not provide substantial excess space between the garment being worn and an intended wearer is at or above the lower end of the range, so long as it is sufficient to support a line against a wearer in a plurality of positions. Because the exemplary outer layer is not intended to provide compressive support, it provides less than an effectively tight fit. Above the higher end of the range, the inner layer would provide substantially excessive compression to secure a line against a wearer's body and may eventually cause extreme discomfort. Any fit that substantially exceeds compression to secure a line against a wearer's body and causes appreciable discomfort is considered above the higher end of the range. Sports bras and other similar athletic support garments for females fall within this category. [0046] Those skilled in the art will appreciate that a garment in accordance with the present invention when worn by a person for whom the garment size is not intended (e.g., an extra large garment worn by a petite person or child, or a small garment worn by a large person) will not fit the wearer properly. Nevertheless, such a garment is still considered to provide an effective tightness or effectively tight fit if it provides sufficient compressive force to secure a catheter line, but not substantially excessive compression that will cause extreme discomfort when worn by a person for whom the garment size is intended. [0047] Stretch fabrics capable of providing an effective tightness are used for the garment. The stretchable material content in the fabric may vary greatly, depending upon the amount of stretch and support needed, or desired. The fabric for the inner layer should be, but is not limited to being, a two-way stretch interlock knit. By way of example and not limitation, the materials may include blends of spandex with cotton, nylon, polyester, rayon, silk, or other stretchable materials. Spandex is a generic name for a variety of elastic textile fibers made chiefly of polyurethane. Lycra® is one example of a spandex fabric available from E. I. duPont de Nemours & Co., Wilmington, Del. Various weights of fabric can be used for the inner layer and outer layer. For example, light, light/medium, medium, medium/heavy, and heavy weights may be utilized. Different weights are preferred for different purposes. In a preferred implementation an 8 ounce (or no less than 4 ounce) double knit 2-way stretch may be used for the inner layer, and an 8 ounce double knit cotton/spandex blend with 5-10% spandex (or a 4 ounce interlock cotton fabric) may be used for the outer layer. The garment should be constructed with the stretch of the inner layer of the garment oriented across the body of the wearer (i.e., horizontally), not up and down (vertically), such that the circumference of the inner layer is allowed to expand. All of these fabrics and blends can provide an effective tightness, excellent comfort and support. Obviously, a complete array of colors and prints are suitable for both the inner layer and outer layer of the garment. [0048] It is the multi-directional stretch characteristics of the fabric, in conjunction with the specific design, that gives the garment, particularly the inner layer, an ability to conform to wearer's physique and provide an effective tightness. The inner layer conforms to and provides a non-constricting, non-restricting, effectively tight fit. The chest and torso are allowed to expand and contract without appreciable resistance. The garment completely accommodates the line in various positions for comfort without pressing the line or lumens into the wearer's body. [0049] Those skilled in the art will appreciate that certain patterns of stretchable materials will achieve a determined effective tightness when worn by a person of an appropriate size. By way of example and not limitation, the inner layer constructions described in FIGS. 8, 8A and 8 B are considered to provide an effective tightness in accordance with the invention, when the materials for the inner and outer layers conform to the preferred material specifications set forth above. [0050] Several aspects of conventional sports bras and other similar athletic support garments for females (referred to collectively herein as “sports bras”) render such garments highly undesirable for use in securing a catheter line against a wearer's body. Most significantly, in sharp contrast to a garment according to the invention, conventional sports bras are designed to exert substantial compressive force to minimize breast motion. A strong elastic material holds the breasts firmly against the wearer's body. While such compressive force is necessary for minimizing breast movement during rigorous activity, it is excessive for supporting a catheter line and leads to great discomfort, pain and swelling when exerted on a regular basis. The discomfort is particularly pronounced when a portion of the wearer's body is swollen and tender, such as soon after implantation of a catheter line. Such compressive force does not constitute an effectively tight fit as contemplated herein. [0051] Another aspect of sports bras and certain other garments that render them highly unsuitable for supporting a catheter line is that the straps are often very thin. Garments having thin straps are extremely problematic because the straps cut into the shoulders of the wearer, particularly larger and more robust wearers. Catheters are often placed into a vein in a patient's neck (internal jugular) or sometimes under the collar bone (subclavian) and tunneled under the skin. Conventional thin straps of sports bras tend to cross a wearer's collarbone over the tunneled catheter line. As conceptually shown in FIGS. 9 and 10 illustrate a sports bra and a garment with spaghetti straps and particular areas of conflict or discomfort with a catheter port or line. Concentrated pressure from thin straps may cause discomfort by abrading or occluding a tunneled catheter line that cross a wearer's clavicle. [0052] Advantageously, a garment according to an exemplary embodiment of the invention avoids placing undue stress on the clavicle region by utilizing wide shoulder supports. Although thin straps such as spaghetti straps may be stylish, they are unsuitable for a garment according to the invention. The shoulder portions of a garment according to the invention are preferably approximately 1½ inches or wider, which is several times wider than conventional spaghetti straps and bra straps. This width is considered minimally effective for avoiding stress concentrations that substantially increase discomfort. The shoulder portions may take the form of wide (1½ inch or wider) straps, T-shirt-style sleeves, or any other shoulder form that provides at least 1½ inches of shoulder support material for avoiding severe stress concentrations at the shoulder region. The width of such shoulder supports is referred to herein as an effectively wide shoulder. [0053] Another problem associated with conventional sport bras and other garments is that they are difficult to put on. For instance, sport bras are typically designed to be placed on over the head and require stretching of the elasticized band in order to do so. Other garments may require tying of straps at the shoulders or buckling of straps across the wearer's back. However, patients with implanted catheters frequently experience soreness, tenderness and an extremely limited range of motion, which significantly impairs their ability to put on such garments. [0054] Advantageously, a garment according to the invention is easy to put on. A wearer can easily put on a garment according to an exemplary embodiment of the invention by pulling the garment over their head, in which case the shoulders may be fastened before or after the garment is pulled on. Alternatively, the wearer can step into the garment, pull it up and then fasten the shoulder portions. Because the shoulder portions are releasably joined, such as using hook and loop fasteners, they are easy to close when the garment is in place or before putting the garment on. [0055] The foregoing detailed description of particular preferred embodiments of the present invention, which should be read in conjunction with the accompanying drawings, is not intended to limit the enumerated claims, but to serve as particular examples of the invention. Those skilled in the art should appreciate that they can readily use the concepts and specific embodiments disclosed as bases for modifying or designing other garments carrying out the same purposes of the present invention, and that such garments come within the scope of the invention. [0056] By way of example, and not limitation, garments with various additional pockets, pouches, and accessories come within the scope of the present invention. Also by way of example and not limitation, garments comprised of other materials than those identified above, e.g., breathable, lightweight and sheer materials, as well as synthetic materials or blended materials, whether now known or later developed, may come within the scope of the present invention. Those skilled in the art should also realize that such equivalent garments do not depart from the spirit in scope of the invention as claimed.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a bio-fertilizer composition, especially relates to a composition containing symbiotic organisms for promoting growth of orchid plants. 2. The Prior Arts Proper fertilizers are important to crops during growth stages since the nutrients in soil may not fully meet the needs. Fertilizer for crops may be classified as chemical fertilizer, bio-fertilizer, green manure and compost. Bio-fertilizer contains microbes or enzymes, and is available in the forms of powder, granule or liquid. When bio-fertilizers are applied on the seeds, seedlings or soils, not only the effectiveness of nutrient uptake can be improved, but also the amount of beneficial microbes can be replenished to maintain soil in good eco-environment. The nutrient level in soil is further elevated, with soil fertility enhanced, nutrient uptake assisted, and the abilities of disease-resistant, drought-enduring, and cold-resistant of crops enhanced. In general, the advantages may be grouped into 3 categories: (1) nitrogen fixation, to fix atmospheric nitrogen into ammonia, and convert into nitrate which can be used by crops, (2) solubilization of soil minerals such as phosphorus, calcium and iron to be used by plants, (3) promotion of the nutrient uptake by roots and plant growth. The Orchid family, Orchidaceae , is one of the most numerous and biggest vascular bundle family. There are more than 80 genuses being identified so far, which stand for more than 20,000 species worldwide. They can be traced from gloomy fresh tropical rainforests to steep cliffs to dry desert regions. Many orchids have medicinal properties besides ornamental importance, such as Dendrobium and Anoectochilus which are of great commercial values. Many of the orchid strains have the problems of low germination rates and low asexual reproduction (agamogenesis) rates. The price of orchids is therefore very high with the long planting and cultivation time. Orchid plants have difficulties in cultivation, slow growth, perplexity in flowering promotion, and numerous problems regarding transplanting, manure, watering, light management and so on. Orchids are mainly propagated using tissue culture techniques, but the survival ability and growth of the seedling are very slow after being transplanted from the cultivating vessels. Many chemical fertilizers in the market containing fixed ratio of inorganic substances, a formula for in common use, are for general purpose but not aimed at certain plants. Therefore, no specific effect is observed. On the other hand, the studies in soil have demonstrated that inorganics have complicated interactions with each other. Increasing the amount of one inorganic will affect the uptake rate of other inorganics, and result in lack of other inorganics. And for the application of organic fertilizers, the main problem is to emphasize the effective use of animal droppings but not to determine the requirement terms of orchids on each element. Animal droppings usually contain low nutrient levels, but organic fertilizers retain moisture contents and nutrients, also release in a slower rate. Though organic fertilizers increase plant growth in the beginning for orchids planting, result in rotten roots of plants after a period of time. This is because of the decomposing of animal droppings, which makes water and air blocked, an ideal environment for bacteria growth. Therefore, the growth rates and yields of orchid plants are decreased. In addition, pathogens and weed may hide in animal droppings to destroy plants. In summary, applying fertilizer is necessary during orchid planting stage, but the objective is incapable of fulfillment with the lacks and disadvantages of chemical fertilizers and organic fertilizers in the market. SUMMARY OF THE INVENTION A primary object of the present invention is to provide a bio-fertilizer composition to solve the problems of abovementioned techniques and promote growth of orchid plants. To fulfill the objective of the present invention, the bio-fertilizer composition according to the invention comprises: a symbiotic organism, which is selected from the group consisting of Rhizoctonia sp. (BCRC930076) and Rhizoctonia sp. (BCRC930077); a growth substance; and a medium, which is used to mix and evenly disperse the symbiotic organisms and the growth substance. The bio-fertilizer composition can be applied to promote orchid seed germination in test tubes, or be applied in seedling growth after deflasking to reach the goals of promoting planting, preventing disease, and increasing the beneficial components toward human health of medicinal orchids. In addition, the composition also increases the flowing rate and flowing quality. The bio-fertilizer composition can be used in a way to increase the yield of orchid seedlings and flowering plants to decrease the impact of chemical fertilizers toward environment. The invention provides a bio-fertilizer composition containing symbiotic organisms for orchid growth, and can be applied in planting orchids to increase the propagation efficiency of seedling, also to breed disease-resistant, easy planting, high yield and more beautiful orchid strains. The present invention is further explained in the following embodiment illustration and examples. The present invention disclosed above is not limited by these examples. The present invention may be altered or modified by people skilled in the art and all such variations are within the scope and spirit of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows the effects of bio-fertilizer compositions in the invention to Haemaria seeds germination rates. Number 1 to 5 indicates different culture media. 1. PDA culture media; 2. peat; 3. vermiculite; 4. perlite; and 5. Sphagnum mosses. FIG. 2 shows the growth effects of bio-fertilizer compositions to Phalaenopsis seedling growth. 1. no fertilizer; 2. bio-fertilizer composition Ma is applied; 3. bio-fertilizer composition Mb is applied. FIG. 3 shows the effects of bio-fertilizers on the amounts of chlorophyll in Phalaenopsis. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The bio-fertilizer composition of the present invention comprises a symbiotic organism, which is selected from the group consisting of Rhizoctonia sp. (BCRC930076) and Rhizoctonia sp. (BCRC930077); a growth substance; and a medium, which is used to mix and evenly disperse the symbiotic organisms and the growth substance. The symbiotic organisms are Rhizoctonia spp. purified and isolated from the wild grown orchid roots. One colony of Rhizoctonia sp., which has been deposited in FIRDI (Food Industry Research and Development Institute Taiwan, 331 Shih-Pin Road, Hsinchu, Taiwan 300) with a deposit number of BCRC0930076, are pale yellow with cotton fibers in the front sides, and the colors of hyphae are also pale yellow. The widths of hyphae are between 3.5-4.5 mm, in average of 3.9 mm. The lengths of bead-like cells are between 17-30 mm, in average of 23.5 mm, and the widths are between 10-12 mm, in average of 11.1 mm. The rate of hyphal elongation is 10-11 mm per day. There are two nuclei in one cell. Another colony of Rhizoctonia sp.,which has been deposited in FIRDI with a deposit number of BCRC0930077, are white yellow with cotton fibers in the front sides, and the colors of hyphae are also white yellow. The widths of hyphae are between 4-5 mm, in average of 4.34 mm. The lengths of bead-like cells are between 14-25 mm, in average of 19.4 mm, and the widths are between 9.6-14 mm, in average of 11.9 mm. The rate of hyphal elongation is 10-11 mm per day. There are two nuclei in one cell. The above-identified colonies were deposited on Dec. 15, 2004. Any known plant growth substance (PGS) which promotes orchid growth and does not interfere with the existence of orchid symbiotic organism can be applied in the present invention and is not limited. The plant growth substances include natural plant hormones and artificially synthesized plant growth regulators. The natural plant hormones include auxins, gibberellins, cytokines, abscisic acid, ethylene, brassinosteroids, jasmonate and salicylates and so on, not restricted to the list here. The plant growth regulators are synthesized by chemical methods which are organics similar to the molecular structures or physiological activities of natural plant hormones. Examples are choline chloride, inositol, Lysine#3 root inducer and Aminosong solution, and are not limited to this list. On the other hand, as a medium mentioned above, any medium used to thoroughly mix and evenly disperse the symbiotic organisms and the growth substances can be applied in the present invention to bring into functions, no particular restriction is applied in the invention. Examples include peat moss, Sphagnum mosses, coconut fiber and rotting logs, and are not limited to the list here. The mixing ratio of symbiotic organisms and plant growth substances of the bio-fertilizer composition in the invention can be adjusted according to the spreading ways, amount, and different growth stages of orchid species. There is no particular restriction. People skilled in the art of the present invention also understand from this explanation that the bio-fertilizer composition can be produced in either solid forms or in liquid forms. On the other hand, people skilled in the art also comprehend that the symbiotic organism of the bio-fertilizer composition can be applied directly into the culture media of orchid seed in test tubes during seed germination without plant growth substance but with simple medium (e.g. oat meal agar medium) to promote the germination. Besides, the bio-fertilizer composition can further comprises a nutrient solution to provide a better growth promotion effect. Any nutrient solution provides nutrients for orchid plants and enhances the growth can be applied in the present invention without particular restriction. Fruit and vegetable juices (for instance, V8 juice), GY nutrient solution (liquid glucose-yeast extract media), CM nutrient solution (glucose-yeast extract-malt extract) and food grade beverage (for instance, milk) are examples but not limited. The present invention is further explained in the following examples. The present invention disclosed above is not limited by these examples. The present invention may be altered or modified and all such variations are within the scope and spirit of the present invention. EXAMPLE 1 Isolation and Purification of Orchid Symbiotic Organisms Orchids are observed after slicing of each orchid plant under microscope, and the roots suspected to be infected with orchid symbiotic organisms are sampled to isolate the microbes from the infected roots. First of all, the roots are washed, sonicated with 1% sodium hypochlorite for 15 to 20 min for disinfection, then washed with sterile distilled water three times. The roots are cut into pieces, placed in separation culture media, and incubated in the dark at 25° C. for 3 to 4 days till mycelia appear. Single hypha picked from mycelium is subcultured into potato dextrose agar (PDA) plate (39 g/L of DIFCO potato dextrose agar) for colony purification. Purification of hypha is determined according to the growth condition of hypha, and the non-purified hypha is picked with a needle, incubated in a fresh PDA plate till colonies are purified. Purified colonies are placed into test tubes respectively and stored at 4° C. The purified symbiotic organisms are identified, termed Rhizoctonia sp. Ma and Rhizoctonia sp. Mb by FIRDI (Taiwan, ROC), and deposited there on Dec. 15, 2004. The deposit number is assigned to be BCRC930076 and BCRC930077, respectively. EXAMPLE 2 Analysis on the Pathogenicity of Orchid Symbiotic Organisms Both Rhizoctonia sp. Ma and Rhizoctonia sp. Mb are analyzed for their pathogenicities to affirm their danger to plants. Sterilized peat mosses or soil-free media are used as the growing media for testing plants. First of all, the surfaces of seeds are disinfected with sodium hypochlorite, these seeds includ crop blocks such as mung beans (bean family), cucumbers (calabash family), radishes (crucifer family) or rice and so on. These disinfected seeds are sowed directly, or germinated in advance, and placed into the media containing purified orchids symbiotic organisms, in the ratio of 0.5-1 g microbes to one plant in a plastic vessel respectively. The water level is adjusted to be the same as in the field. The container and the plant are wrapped with a large transparent plastic bag to prevent the spreading of harmful microbes, and the plant was kept away from the side of bag to avoid the abnormal growth. These bags are placed in a green house with normal illumination for 7-14 days. The growth of each plant is observed to confirm whether it has symptoms. Finally, no symptom is observed. Therefore these symbiotic organisms obtained in this experiment show no pathogenicity. EXAMPLE 3 Preparation of the Bio-Fertilizer Composition Culture media containing 39 g of Difco PDA (potato dextrose agar) in one liter of water are autoclaved at 121° C. for 20 minutes to cultivate the purified orchid symbiotic organisms obtained from Example 1, which are stored as the seed stocks. The orchid symbiotic organisms can be cultivated and produced in liquid form or solid form. GY culture solution (2% of glucose and 1% of yeast extract), CM culture solution (5 g each of glucose, yeast extract and malt extract are added to one liter media), and MP culture media (2.5% of milk powder) are applied for liquid form cultivation. These culture solutions are autoclaved for 20 min to be sterile. After the media are cooled, the abovementioned orchid symbiotic microbial seed stocks are inoculated to cultivate either stay quiet at 25° C. or shake at low speed (80-100 rpm). Five days later, the solution of culture media ias ground with a disinfected juice grinder to disperse the mycelium and stored in a sprinkling can. When orchid symbiotic organisms is cultivated in solid form, media for cultivation of mushroom or mushroom spawn or orchid such as peat moss, Sphagnum mosses, coconut fiber or rotting logs are mixed thoroughly in a ratio with the abovementioned liquid culture solution and autoclaved for 60 min. After the media are cooled, the abovementioned orchid symbiotic microbial seed stocks are inoculated in the surface of this medium. Cultivation can be carried out in the dark in sterile compact packs or in shallow dishes less than 1.5 cm thick). After several days, when the mycelium grows all over the surface of media, the mycelium can be mixed evenly and used for inoculation, or be dried with media in the shade in a sterile environment, then put into sealing bags and store at 4° C. refrigerator, the mycelium can be stored for more than 6 months. The proper cultivating temperature for orchid symbiotic organisms is around 25-28° C., usually without illumination. The bio-fertilizer composition of the invention is prepared after the orchid symbiotic organisms are mixed with plant growth substances and suitable media. EXAMPLE 4 Enhancement of Haemaria Seed Germination Rhizoctonza sp. Ma and Rhizoctonia sp. Mb isolated from Example 1 are spread into different culture media, such as PDA culture media, peat, vermiculite, perlite and Sphagnum mosses. The seeds of Haemaria are inoculated into the abovemetioned culture media to observe the germination. FIG. 1 shows the results of germination rates with different treatments. Haemaria seeds do not germinate no matter what kind of culture media is used without the addition of orchid symbiotic mibrobe (Control group). And germination rates are significant higher than those of control groups when the orchid symbiotic organisms are added. Among them, the germination rate of the PDA culture media group is the highest, which reached 25-30%. EXAMPLE 5 Enhancement of Haemaria Seedling Growth with Different Fertilizers During Tissue Culture The seedlings of Haemaria (about 1 cm in height) are planted in oat culture media (2.5 g of ground oat bran and 11.5 g of agar, add water to one liter) and divided into four groups; no fertilizer group (NM, control group); Hyponex No. 3 (commercial chemical fertilizer) added group; bio-fertilizer composition Ma added group (Ma) as described in Example 3 containing Rhizoctonia sp. Ma (BCRC930076); and bio-fertilizer composition Mb added group (Mb) as described in Example 3 containing Rhizoctonia sp. Mb (BCRC930077). The growth of seedlings of Haemaria in different groups is compared after 4 months. Each treatment contains 15 duplicates, and the data is analyzed with Duncan's multiple range test (DMRT) using p-value of 0.05. As shown in Table 1, the addition of fertilizers significantly enhances the growth conditions of plants in comparison with the plants of the control group. Among the three former groups, Hyponex No. 3 added group shows the significantly enhancing effects in plant heights only, while the bio-fertilizer composition added groups show significant effects in plant heights, leave lengths and fresh weights when compared to the control group. Other values such as leave widths and root numbers are also higher than those of the control group though not significantly. In summary, the bio-fertilizer composition in the present invention indeed effectively improves the growth of the seedlings of Haemaria , and is better than the effects of chemical fertilizer. TABLE 1 Growth of Haemaria seedling during tissue culture after 4 months of fertilizer addition Plant Leave Leave Fresh height Leave length width Root weight Treatment (cm) number (cm) (cm) number (g) NM 5.1 b 1.9 a 1.2 b 0.7 a 3.6 a 278.7 b Hyponex 5.3 a 2.0 a 1.2 b 0.7 a 3.7 a 390.8 b No. 3 Ma 5.8 a 2.0 a 1.7 a 0.9 a 4.4 a 538.3 a Mb 5.9 a 2.2 a 1.7 a 0.9 a 5.0 a 567.6 a EXAMPLE 6 Enhancement of Haemaria Seedling Growth in Different Heights During Tissue Culture The seedlings of Haemaria (6-9 cm in height) are divided into 2 groups by heights (6-7 cm in height vs 8-9 cm in height) and planted in oat culture media. Each group is further divided into 3 groups: no fertilizer group (NM control group); bio-fertilizer composition Ma (BCRC930076) added group from Example 3; and bio-fertilizer composition Mb (BCRC930077) added group from Example 3. The growth of seedlings of Haemaria in different groups is compared after 4 months. Each treatment contains 20 duplicates, and the data is analyzed with Duncan's multiple range test (DMRT) using p-value of 0.05. As shown in Table 2, the addition of fertilizers (treatment groups) shows significant effects on both of the seedlings of Haemaria in plant heights, leave numbers and fresh weights in comparison with those of the plants from the control group, and showed better growth conditions. TABLE 2 Growth of Haemaria seedling in different sizes during tissue culture after 4 months of bio-fertilizer addition Plant Leave Leave Fresh Seedling height Leave length width Root Node weight size Treatment (cm) number (cm) (cm) number number (g) 6-7 cm NM 10.1 c 3.8 b 2.6 b 1.5 b 2.6 d 5.6 b 2.6 c Ma 10.7 c 4.4 ab 3.2 ab 1.9 a 3.0 c 6.8 a 3.7 b Mb 10.6 c 4.0 b 3.6 ab 1.9 a 3.6 c 7.2 a 4.0 b 8-9 cm NM 12.4 b 3.6 b 4.0 a 1.9 a 6.2 b 7.0 a 4.2 b Ma 13.2 a 4.8 a 4.3 a 2.0 a 7.0 a 7.2 a 6.3 a Mb 13.1 a 5.2 a 4.2 a 1.9 a 7.4 a 7.4 a 6.5 a EXAMPLE 7 Enhancement of Dendrobium candidum Seedling Growth with Bio-Fertilizer After Deflasking from Tissue Culture The seedlings of Dendrobium candidum are planted in oat culture media after deflasking from tissue culture, and divided into 3 groups: no fertilizer group (NM control group); bio-fertilizer composition Ma (BCRC930076) added group from Example 3; and bio-fertilizer composition Mb (BCRC930077) added group from Example 3. The growth of seedlings of Dendrobium candidum in different groups is compared after 4 months. Each treatment contains 20 duplicates, and the data is analyzed with Duncan's multiple range test (DMRT) using p-value of 0.05. As shown in Table 3, the addition of fertilizers (treatment groups) improved the growth of Dendrobium candidum in comparison with the control group, and the survival rates of treatment groups are 20% better than that of the control group. TABLE 3 The effect of inoculaing bio-fertilizer composition for 4 months to seedlings of Dendrobtian candidum Wall. ex Linkl. after deflasking Plant Length of Width of Fresh height pseudobulb pseudobulb Number Root Auxiliary weight Survival Treatment (cm) (cm) (mm) of leave number bud (g) rate (%) NM 3.9 b 2.6 a 1.1 c  8.3 c 4.5 c 3.7 bc 0.3 b 77 Ma 4.9 a 3.2 a 1.4 ab 14 ab 7.8 ab 4.5 abc 0.7 a 97 Mb 5.0 a 3.2 a 1.3 bc 15.6 a 8.6 a 5.7 a 0.7 a 95 EXAMPLE 8 Enhancement of Phalaenopsis Seeding Growth with Bio-Fertilizer During Tissue Culture The seedlings of Phalaenopsis are planted during tissue culture, and divided into 3 groups; no fertilizer group (control group); bio-fertilizer composition Ma (BCRC930076) added group from Example 3; and bio-fertilizer composition Mb (BCRC930077) added group from Example 3. The growth of seedlings of Phalaenopsis in different groups is compared after 4 months. Each treatment contains 5 duplicates, and the data is analyzed with Duncan's multiple range test (DMRT) using p-value of 0.05. The effect of addition of fertilizers (treatment groups) in the growth of Phalaenopsis in comparison with the control group is shown in FIG. 2 . The root numbers and fresh weights of treatment groups are significantly higher than those of the control group. EXAMPLE 9 Enhancement of Phalaenopsis Seedling Growth with Bio-Fertilizer After Deflasking from Tissue Culture The seedlings of Phalaenopsis are planted after deflasking from tissue culture, and divided into 3 groups; no fertilizer group (NM control group); bio-fertilizer composition Ma (BCRC930076) added group from Example 3; and bio-fertilizer composition Mb (BCRC930077) added group from Example 3. After 4 months, the growth of seedlings of Phalaenopsis after deflasking in different groups is compared. Each treatment contained 5 duplicates, and the data is analyzed with Duncan's multiple range test (DMRT) using p-value of 0.05. The effects of fertilizers (treatment groups) in the growth of Phalaenopsis in comparison with the control group are shown in FIG. 3 . The contents of chlorophyll of treatment groups are significantly higher than those of the control group. EXAMPLE 10 Enhancement of Flowering Rates with Bio-Fertilizer and Plant Growth Substance Phalaenopsis amabili and Doritaenopsis casablanca Joy×Phalaenopsis taida Pinlong are treated with either bio-fertilizer composition Mb or plant growth regulators Gibberellic Acid (GA 3 ), or both. The flowering rates are observed after incubation. As shown in Table 4, the addition of bio-fertilizer Mb and GA 3 (treatment groups) improved the growth of both Phalaenopsis to a large extent: 92% and 88% respectively, in comparison with 42% of the control group (NM), which is 50% better than that of the control group. TABLE 4 The flowering rates of both Phalaenopsis after treatments of bio-fertilizer composition Mb and/or plant growth regulators gibberellic acid (GA 3 ) at room temperature Doritaenopsis casablanca Phalaenopsis Joy × Treatment amabilis Phalaenopsis taida Pinlong NM 42 42 Mb 42 45 NM + GA 3 75 71 Mb + GA 3 92 88 EXAMPLE 11 Anoectochilus formosanus is treated with either bio-fertilizer composition Mb (Mb) or nothing (NM). The changes on effective components are analyzed after incubation. The treatment contains 4 duplicates, and the data is analyzed with Duncan's multiple range test (DMRT) using p-value of 0.05. Table 5 shows the comparison analysis of bioactive components with health benefits such as superoxide dismutase (SOD), polysaccharids, polyphenols, phosphorus ions and vitamin C with or without the addition of bio-fertilizer Mb. The bio-fertilizer composition Mb (treatment group) significantly increased the effective components of Anoectochilus formosanus to a large extent. TABLE 5 Analysis of bioactive components superoxide dismutase (SOD), polysaccharids, polyphenols, phosphorus ions and vitamin C in the leave, stems and roots of Anoectochilus formosanus Plant SOD Polysaccharids Polyphenols Phosphorus Vitamin Treatment tissues (units/ml) (mg/ml) (mg/ml) ions (mg/l) C (mg/l) NM Leave 21.1 b 15.1 b 5.2 bc 336.0 b 173.3 ab Stem 10.5 c  1.2 d 2.2 d 297.5 b  73.7 c Root  5.3 d  6.8 4.5 c 141.3 c  80.0 c Mb Leave 34.2 a 22.8 a 7.1 a 452.4 a 270.0 a Stem 12.4 c  8.9 c 3.9 cd 331.2 b  74.9 c Root  9.5 cd 17.2 b 6.2 b 167.2 c 135.9 b

1a

TECHNICAL FIELD The present invention relates to a display device for wristwatches and/or wristbands. BACKGROUND OF THE PRIOR ART Conventional devices for displaying wristwatches and wristbands generally comprise a curved wristwatch and wristband supporting member to the lower end of which is secured a base or foot member. Exemplary of such devices are those shown in U.S. Pat. Nos. 2,549,369, 4,082,183 and 4,216,858. The construction of conventional wristwatch and wristband display devices requires that they always be supported on a horizontal, or nearly horizontal, surface. whether that surface be located within a display case, or on a countertop. A retailer, therefore, is limited both as to the number, and the arrangement of, watches and/or bands that can be positioned in a display case or on a countertop. The restrictions thus placed upon a retailer of such items also limits his ability to display them in a manner which will best attract the attention of customers and enable them to best select the wristwatch and wristband they may wish to purchase. BRIEF SUMMARY OF THE INVENTION In accordance with the present invention, a display device for wristwatches and wristbands has been evolved which can be supported with equal facility on either a horizontal, or nearly horizontal, surface, or a vertical or slanted surface. In brief, the display device comprises a generally C-shaped, upwardly extending wristwatch and wristband retaining portion having a pedestal or base member joined to the lower end thereof and a panel engaging bracket-like member joined to the upper end thereof. The pedestal or base member enables the display device to be supported on a horizontal, or nearly horizontal, surface in a manner similar to conventional wristwatch and wristband display devices of the type shown in the aforementioned U.S. patents. The panel engaging bracket-like member, on the other hand, enables the display device to be supported, independently of the pedestal base member of the device, on a vertical or slanted surface. To this end, the bracket-like member is provided with extension means adapted to be detachably engaged in an opening or hole formed in a support panel. The support panel advantageously is provided with a plurality of such openings of holes, and can be free standing for use on a countertop, for example, or it can be secured to a wall or other supporting surface. The ability to arrange the display device of this invention in both vertically and horizontally aligned relation on such a panel gives a retailer extraordinary flexibility from the standpoint of being able to not only support an appreciable number of the devices on a panel, but, also, to do so in a manner which will be most appealing to customers, and will present to a purchaser a wider variety of items for his or her selection. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view in perspective of an embodiment of the display device of the present invention supported on a panel, and having a wristwatch and band postioned therein; FIG. 2 is a front view in elevation of said embodiment of the invention; FIG. 3 is a rear view in elevation of said embodiment of the invention; FIG. 4 is a side view in elevation of said embodiment of the invention; FIG. 5 is a fragmentary side view of said embodiment of the invention showing the extension means on the bracket-like member of the device being engaged in an opening formed in a panel; and FIG. 6 is a sectional view taken substantially along line 6--6 of FIG. 5. DETAILED DESCRIPTION OF THE INVENTION Referring, now, to the drawings, FIG. 1 shows a display device constructed in accordance with the present invention, and designated generally by reference numeral 10. The display device 10 is advantageously manufactured as a single molded piece from a suitable plastic material. As shown, the display device 10 has a generally L-shaped base member 12, provided with a face plate 14 extending from the front terminal edge of the base member 12. Face plate 14 can be used to display information concerning the identity, quality, and price of a wristwatch 16 and watchband 18 displayed on the device. Integrally formed with a side edge of base member 12 is an upwardly-extending connecting wall 20, defining a lower passage 22 immediately above base member 12 and bordered on one side by connecting wall 20. An inverted, generally C-shaped member 24 is integrally formed at its bottom curved section 26, with the top face of connecting wall 20. Preferably, C-shaped member 24 is joined to the base member 12 at an angle whereby the bottom curved section 26 is forward of the upper curved section 30 of C-shaped member 24. Bottom curved section 26 preferably tapers as it extends upward into the central section 28 of the C-shaped member 24. Central section 28 has sufficient width to allow wristwatch 16 and watch band 18 to be displayed while at the same time enabling the member to be flexed to accommodate wristbands of various lengths and types. The central section 28 of the member 24 widens into upper curved section 30. Further structural support for C-shaped member 24 can be provided by one or more reinforcement beads or bars 32 and 34 positioned on the internal side of C-shaped member 24 (See FIG. 4). A generally U-shaped bracket-like member is integrally formed with the outer side edge of the upper curved section 30. The member 30 is provided with an extension 38. The extension 38 may have the configuration of a keyhole, as illustrated, or it may take the form of a headed stud, or be hook-like in shape. The positioning of member 36 with respect to the top curved section 30 creates an upper passage 40. The upper passage 40 and the lower passage 22 serve to permit lateral sliding of a watchband such as watchband 18 onto the C-shaped member 24. A watch band having a clasping or buckle closure can also encompass C-shaped member 24 by inserting one end of the watchband through lower passage 22, the other end of the band through upper passage 40, and engaging the clasp or buckle closure of the band, so that the band closure remains in the open section 44 of the C-shaped member 24. As best shown in FIG. 5, the extension 38 of the bracket-like member 36 is matched with a keyhole opening 46 on a display panel 48, and is inserted through the opening 46 until the member 36 abuts the front face of the panel 48. By sliding the display device 10 in a downward direction, the extension will be behind panel 48 and will be detachably locked into position. To remove the display device 10 from the panel 48, the display device 10 is moved upwardly until the extension 38 is in register with the opening 46 in the panel 40, and is then separated from the panel. The panel 48 desirably is provided with a plurality of spaced openings 46 as illustrated in FIG. 1, and, as indicated, can be freestanding, or be affixed to a wall. While a specific embodiment of the invention has been illustrated and described, numerous modifications may come to mind without significantly departing from the spirit of the invention, and the scope of the protection is only limited by the scope of the accompanying claims.

1a

BACKGROUND OF THE INVENTION [0001] A personal air conditioning unit portable by a person is known from U.S. Pat. No. 6,427,476 B1. This air conditioning unit is built as a backpack and consists of a large volume, insulated basic case as the container for a chilled substance, ice for instance. Several cooling pipes are led through this case, through which air is blown by a fan located in a separate sealed part of the case, drawing in the surrounding air. After the cooling pipes come into contact with the chilled medium a heat transfer takes place, the air pumped through the cooling pipes being chilled. The cooling pipes terminate in a collar shaped air diffuser, which partially surrounds the person's neck and through which the chilled air is discharged. [0002] This portable backpack air conditioning unit can be carried along relatively easily by the user and offers him some cooling in his leisure time, during sporting and other activities as for instance in a work place, where he is active in high ambient temperatures. The purpose of this air conditioning unit is at the same time strictly limited to the provision of personal air conditioning. The user, be it the sports person, hiker or worker for instance, may however develop other needs through their activity, mainly the quenching of thirst as a consequence of high levels of perspiration in particular. The level of this need may be reduced somewhat by the cooling since the general feeling of well being by the persons will be a little higher as a result of the cooling, nevertheless this basic need cannot be totally eliminated. SUMMARY OF THE INVENTION [0003] The invention therefore relates to a personal air conditioning unit, which is improved in relation to its function or respective usability. [0004] The invention provides a portable personal air conditioning unit attachable to a person's body with a receptacle for a detachably insertable latent heat storage device with a filler opening, which contains or accepts a consumable storage medium, frozen for the air conditioning operation. This receptacle is equipped with an intake for the air to be directed past the latent heat storage device and to undergo heat exchange there, and an outlet for the release of the chilled air and also a fan, driveable by a power supply contained within the receptacle, for delivering the air in a self-sufficient operation of the personal air conditioning unit, whereby at least one extraction device is provided for the extraction of thawed consumable storage medium used as a drinking liquid by the person. [0005] In a preferred embodiment, the invention provides the use of a latent heat storage device, which is removable from the basic receptacle and is filled with a frozen storage medium of a consumable kind. This latent heat storage device is to be placed inside the receptacle by the user of the air conditioning unit after transformation of the storage medium into its frozen state. If cooling is now required as the result of the person's activity, this will be provided by the receptacle-mounted fan, which draws surrounding air from outside the personal air conditioning unit and delivers it along the side of the closed latent heat storage device, resulting in a heat exchange; the air gets chilled and can as such be supplied to the person. During this process a heat exchange takes place as described, resulting in the frozen storage medium slowly thawing. In the event of the person becoming thirsty as a result of his activity, he has the advantage of being able to extract the thawed storage medium no longer required for chilling the air as such via the extraction device and to consume it as drinking liquid, as long as the storage medium is of a consumable kind as described. Preferably, clear water or any other water-based liquids such as isotonic drinks, juices etc. is used but any consumable and freezable storage medium may be used. [0006] The advantage of the air conditioning unit in accordance with the invention is that it is multifunctional, as on the one hand it allows adequate personal cooling and on the other is always available as a drink reservoir as the person may extract the thawed portion of the storage medium at any time. For a long period of time the person therefore has a drink reservoir available, the size of which is ultimately determined by the volume of the latent heat storage device. How soon a consumable quantity of liquid is available is ultimately governed by the speed of the thawing process. This is ultimately determined by the intensity of the heat exchange, therefore whether and to what degree the air gets chilled, and by the surface area of the latent heat storage device at which the heat exchange and consequently the thawing process occur. The person will at any rate greatly appreciate that a single unit provides him with adequate cooling and also a drink supply. [0007] To allow for easy transport of the personal air conditioning unit the receptacle, which preferably is suitably insulated to prevent early thawing of the storage medium or the thawing process being caused by the surrounding air not specifically drawn past the latent heat storage device, is mounted inside a backpack fitted with straps; alternatively it can also be mounted inside a shoulder or waist bag. The personal air conditioning unit can however come in any form, as long as easy transport is assured. External dedicated openings are provided in the air conditioning unit in any case, which are connected to the receptacle openings via suitable connecting pipes so that surrounding air can be drawn in and chilled air can be discharged to the outside by the fan. [0008] By taking the invention idea further, the latent heat storage device could be designed to contain a liquid accumulator or such that one is separately assigned to it, in which at least part of the thawed storage medium collects and which is fitted with the extraction device. The thawed storage medium over time collects in the liquid accumulator, which normally does not need to be of a dimension to contain the total quantity of thawed storage medium, as frequent extraction and therefore draining of the liquid accumulator occurs as a rule. Should on occasions the liquid accumulator be full however, the thawed liquid will ultimately remain in the latent heat storage device or the storage compartment containing the frozen storage medium and will only flow on into the liquid accumulator when this is drained. [0009] In this configuration the assigned liquid accumulator could be joined to the latent heat storage device via a valve, which could be operated manually by the user if necessary. It would be practical for this separate liquid accumulator, which is preferably positioned outside the receptacle, to be connected to the latent heat storage device in a detachable way so that both components can be removed separately for cleaning or for respective removal of the latent heat storage device only, when the storage medium requires freezing again; it would be practical to do this in suitable freezing devices (refrigerator or equivalent). [0010] As an alternative to mounting a separate liquid accumulator inside the backpack, bag or air conditioning unit generally, the liquid accumulator could also form an integral part of the latent heat storage device and be connected to the storage compartment containing the frozen storage medium via one or more drainage openings. This has the advantage that the thawed liquid is continuously drawn away from the storage compartment containing the frozen storage medium and therefore prevents insulation of the frozen storage medium from the storage wall by the thawed liquid contained therein, which limits the chill transfer to the air being delivered through. [0011] The latent heat storage device itself and, possibly also the separate liquid accumulator assigned to it could have either a solid or a flexible case. The employment of flexible cases in particular is of advantage as this can guarantee that the outer wall of the latent heat storage device will hug the contours of the thawing storage medium continuously, consequently the storage wall will always be lying closely against the frozen storage medium, resulting in an optimum transfer of cooling temperature. This leads to improved cooling efficiency after the insulating layer of thawed liquid described earlier no longer exists as the result of the continuous draining and the storage wall is capable of optimum adaptation to the shape of the frozen storage medium. A solid latent heat storage device can for instance be shaped as a pocket or container, while a flexible latent heat storage device could be shaped as a hose or bag. [0012] As the thawing rate of the frozen storage medium is naturally higher in the air intake area, due to the higher temperature difference to the outside air here than it is at the air outlet, a functional development of the invention provides for the latent heat storage device to be designed wider in the area facing the air intake compared to that facing the air outlet. This way the variation in the thawing rate can be compensated in a manner that maintains the maximum ice core surface area possible throughout the entire thawing period. A primarily triangular shape would be practical while other shapes such as a teardrop shape ore equivalent are also conceivable. It would be practical if the shape of the receptacle itself would principally match the shape of the latent heat storage device, at least in its frozen state. In this way the frozen latent heat storage device can on the one hand be inserted into the receptacle easily, on the other hand this creates a principally defined airflow path between the inner wall of the receptacle and the outer wall of the latent heat storage device after both have adapted a uniform shape. The receptacle itself can be solid or flexible, even elastic. [0013] To enable a sufficient airflow an advantageous development of the invention requires that means for the creation of an air slot encompassing the latent heat storage device preferably on all sides are in place on the receptacle side and/or on the storage side. This means will ensure a wide enough gap between receptacle and latent heat storage device to allow a sufficient flow cross section, through which an adequate quantity of air can be delivered. When employing flexible materials in particular in the creation of the latent heat storage device and also the receptacle, it will in practice not always be possible to realize a fully encompassing air slot around the latent heat storage device, however a sufficiently large ventilation cross-section should be provided at all times. One or more spacers for instance can be used to distance the latent heat storage device from the receptacle as means to create the air slot. These could for instance be provided in the form of ledges or ribs or equivalent. It is possible to have a spring suspension of the latent heat storage device with springy spacers, which in the case of a sufficiently solid construction of the receptacle press down on the case of the latent heat storage device and bring this into contact with the frozen storage medium as long as possible, provided the storage case is sufficiently flexible. [0014] According to the invention, a preferably detachable flexible fluid tube can be attached to the latent heat storage device or the separate liquid accumulator to allow for easy extraction of the thawed storage medium. In the air conditioning unit version as a backpack for instance, this sufficiently long tube will be led over the person's shoulder so that it is always readily available close to the person's head and the person can suck in the liquid without difficulty. To this end appropriate clamps can be provided for instance in the area of the straps, in which the fluid tube can be secured when not in use. As an alternative or in addition to this it is also conceivable to provide a sealable drinking or outlet opening on the removable latent heat storage device. To this end however the latent heat storage device needs to be removed from the receptacle. This could for instance be a screw-on cap or equivalent. Such an outlet could of course be provided on the separate liquid accumulator, which then needs to be removed also from the air conditioning unit for tapping. This is particularly easy with a connection between latent heat storage device and liquid accumulator via a valve, which could then be closed to avoid spilling the thawed liquid. At last, as an alternative or in addition a drain valve could also be provided, which can be operated from the outside and through which for instance a drain pipe terminating on the outside of the backpack for example could be opened and closed. [0015] If a liquid pipe is employed, it would be practical to provide a locking device at its forward end, for instance in the shape of a plug-in cap, a turn-lock fastener or equivalent, to prevent dripping. [0016] Another functional development of the invention provides a separate removable liquid accumulator be fitted with a filler opening for the purpose of filling with a consumable liquid, which can be extracted through the extraction device. This version has the advantage that the liquid accumulator can be utilised from the start as a drink reservoir. That means that prior to using the device the person will insert the frozen latent heat storage device and also a liquid accumulator filled with a drinking liquid and will couple these. As a consequence of the liquid contained in the liquid accumulator from the start the person has access to a certain liquid reservoir for drinking from the beginning and therefore does not have to wait for the thawing of a sufficient quantity of the storage medium. With advancing cooling operation the liquid accumulator will be continually refilled and serves as drink reservoir. [0017] As an alternative to the utilisation of the separate liquid accumulator as an initially filled drink reservoir, one version of the invention provides another detachable storage, either filled or capable of being filled with a consumable liquid, which is or can be coupled to the latent heat storage device, the separate liquid accumulator or directly to the extraction device. The person therefore has the opportunity to integrate an additional drinking liquid storage into the backpack for instance and couple this in accordance with the version used to have an adequate liquid reservoir available in this way at the start of operating the air conditioning unit. Naturally, the additional drinking liquid storage can also be used in connection with the removable and initially fillable liquid accumulator. [0018] A latent heat storage device can achieve remarkable air-cooling by several Kelvin, whereby a latent heat storage device also has sufficient refrigeration capacity. In the event of the person's individual perception of the cooling being too strong, a practical version of the invention provides for a second air intake for unchilled air to be mixed with the chilled air, where it would be practical for the air intake to be installed in line with an air duct led into the receptacle and terminating in front of the common air outlet. Through this the warm surrounding air can be mixed with the chilled air, so that the air ultimately supplied to the person can be tempered. [0019] For this it is advantageous that a preferably flap-type or slider-type regulating element is envisaged, through which the aperture of the supply path for the unchilled air is variable. This means that the person can adjust the aperture and therefore the amount of applied unchilled air either manually or, possibly, automatically controlled via the integrated electronics or respective control device. It is particularly advantageous when the regulating element is positioned in such a way that the aperture of the supply path for the unchilled air and the exhaust path of the chilled air for the adjustment of the respective air volumes is variable simultaneously. This too can be done manually or electrically, particularly controlled via the integrated power supply or control device respectively. [0020] It would be practical to employ the fan already integrated into the receptacle anyway for drawing and delivering of the unchilled air. Alternatively, there is the possibility to provide at least one further fan for drawing and delivering of the unchilled air. [0021] The embodiment of the invention described earlier allow tempering of the air supplied to the person. So as to make this tempering process as comfortable as possible, a preferred embodiment of the invention provides a thermostat for the person to operate for temperature adjustment of the possibly mixed air supplied to the person. Therefore the person can select a temperature through a suitable device, whereby, subject to this selection, the thermostat automatically controls the air conditioning operation such as the speed of the fan or fans for instance, or the position of the regulating element and by this the mixing operation. For this, one or several suitable sensors are provided, through which for example the temperature of the possibly mixed air is measured at the air outlet, or the fan speed, or the control flap position is determined. [0022] Furthermore, it is practical in any case if the person can vary the fan speed, with the result that in this way the person can also vary the fan intensity. In case the fan speed is too high and the air therefore blown too hard, one can make the respective adjustment. To this end a control knob for instance or equivalent is provided in an appropriate position. [0023] Rechargeable battery cells, batteries or fuel cells can supply power. Solar cells mounted on the outside of the device are also possible, however these need to be protected against damage. Furthermore, it would be practical to provide a charging state indicator for the integrated power supply. It is possible to use several energy sources in parallel, for instance rechargeable battery cells and solar cells, through which the rechargeable batteries can be recharged continuously. [0024] In addition to a charging state indicator for the integrated power supply further means can also be put in place for monitoring the charging state of the latent heat storage device and a charging indicator could be provided. These means monitor for instance the quantity of the remaining frozen storage medium, so as to determine with this information for how long these quantities will be sufficient for adequate cooling. [0025] This can be done for example by monitoring the weight of the frozen storage medium or the quantity of thawed storage medium drained. [0026] Several options are conceivable for applying the chilled air to the person. According to one version of the invention, a hose-like air tube is to be coupled to the receptacle outlet supplying the air to the person carrying the air conditioning unit. This could be a tube with a single outlet opening; alternatively it could also have one or more branches so that the air could be applied to the person in several places. The tube or tubes are inserted into existing openings of the person's clothing (for example collar, sleeves). Alternatively it is possible to provide coupling means at the receptacle outlet for coupling of an air tube supplying air to a piece of clothing with integrated outlet openings worn by the person. This means that in this version the air conditioning unit is coupled to respectively configured clothing (shirt, jacket, trousers, overalls for instance), which contains integrated air tubes and outlet openings in a distributed configuration. [0027] Where the air tube is only led under the normal clothing it would be practical to fit, preferably in a detachable way, an outlet section to the air tube, made to any form of ductile and preferably skin friendly material and containing several outlet jets. This should primarily be saucer or semi-saucer shaped and contain several multi-directional outlet jets. This possibly palm-sized outlet section could be suitably fastened under the shirt for instance so that it could distribute the air in accordance with the directions of the outlet jets. [0028] A further option could be the ability to close the air intake and outlet openings provided for the air conditioning unit for instance in a backpack with suitable flaps or equivalent when not in use to prevent dirt from getting into the system. [0029] Finally the possibility exists to utilise the latent heat storage device or an additional latent heat storage device respectively, which can be placed inside the receptacle in the same way, not for cooling storage but to use it instead for heat storage. To this end the latent heat storage device or additional devices respectively are filled with a heat storage medium. The functions of the personal air conditioning unit are then consequently reversed; it is used to warm the air supplied to the person when the air conditioning unit is for instance being used in a very cold environment. A wax-like substance for instance, which is filled into the latent heat storage device for example in pearl or ball shape, can be used as heat storage medium. By using this heat storage medium, which, similar to the frozen storage medium, also has an adequate heat storage capacity, air warming can take place for a remarkable length of time. Naturally, the drink option is not available in this case. This version however offers in addition to the principal use in accordance with the invention of the personal air conditioning unit as a cooling device and simultaneous drink reservoir the option of using the air conditioning unit in a multifunctional way for personal warming if required. [0030] Further advantages, characteristics and details of the invention become evident from the following examples and through the accompanying drawings. [0031] FIG. 1 is a schematic diagram of an air conditioning unit in accordance with a first embodiment of the invention, [0032] FIG. 2 is a schematic diagram of an air conditioning unit in accordance with a second embodiment of the invention, [0033] FIG. 3 is a schematic diagram of an air conditioning unit in accordance with a third embodiment of the invention, [0034] FIG. 4 is a schematic diagram of an air conditioning unit in accordance with a fourth embodiment of the invention, and [0035] FIG. 5 is a partial view showing the control elements of an air conditioning unit in accordance with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0036] FIG. 1 depicts by way of a schematic drawing an air conditioning unit 1 in accordance with the invention, which is used both to generate chilled air and also to supply drinking liquid. The air conditioning unit 1 is equipped with a backpack-like carry frame 2 with a backpack-like outer case 3 , which usually is made of flexible and mostly waterproof material as in ordinary backpacks, but which can also be made from solid material in knapsack form. The device can be carried on the back with suitable carry straps 4 . [0037] Inside the backpack-like flexible case, which is made preferably from an insulating material or has an adequate insulation layer 5 respectively (see FIG. 2 ), a receptacle 6 is placed either firmly integrated or detachable by way of zippers, plug-in fasteners or equivalent. The receptacle 6 can be made from solid plastic material, but it can also be made flexible itself, therefore being variable in its shape and therefore adaptable. [0038] In the receptacle 6 a latent heat storage device 7 is placed, containing a frozen and wholesome storage medium 8 consumable by the person P carrying the air conditioning unit, which could be for instance frozen clear water or any other water-based drink like an isotonic drink for example or juice or equivalent. While the receptacle 6 can also be made of a thermal insulating material, the case of the latent heat storage device consists of a material allowing a high degree of heat exchange, preferably a very thin plastic. The case can be of a solid or rigid form; as an alternative the employment of a flexible case in the shape of a bag or hose as depicted in FIG. 1 is also conceivable. [0039] Through an air intake opening 10 air is drawn in by a fan 11 integrated in the receptacle and, as indicated by the arrows, is delivered past the cold latent heat storage device 7 . This results in a heat exchange; the air is chilled here and passes through the outlet 12 in the shown example to an air pipe 13 , which is led to the person in the collar area, where it is being discharged through suitable air outlet openings. In this way air-cooling can take place for up to several hours, depending on the size of the latent heat storage device, as long as it contains frozen storage medium. [0040] FIG. 1 illustrates further how in the shown example a fluid pipe 14 attached to the lower section of the latent heat storage device 7 is led over the person's shoulder to be within the person's reach. As a result of the heat exchange the frozen storage medium slowly thaws and, since the frozen storage medium is lighter than the thawed one, collects in the lower section of the latent heat storage device 7 . Coupled to this is the fluid pipe 14 , through which the person can now suck in and drink the thawed liquid, if required. It should already be pointed out here that just as the receptacle 6 is detachable, the connection of pipes 13 and 14 to the receptacle and latent heat storage device respectively can be detachable, for example via suitable screw plugs or stop plugs etc. This is of particular advantage in the case of the fluid pipe 14 to allow easy cleaning. In each coupling area a suitable valve or equivalent, which automatically opens when a respective pipe is connected and closes when it gets disconnected, can of course be provided. [0041] FIG. 2 depicts an air conditioning unit 1 a in a second version in accordance with the invention in the form of an enlarged schematic diagram. The latent heat storage device 7 is fitted with a filler opening 15 , through which it can initially be filled with the consumable liquid. A liquid accumulator 17 is coupled downstream from the latent heat storage device 7 through a valve 16 ; in the depicted example the fluid pipe 14 coupled to the liquid accumulator is detachable, whereby here also a valve or equivalent could be provided in the coupling area. This liquid accumulator 17 collects the thawed liquid resulting from the heat exchange; it is therefore drawn away from the latent heat storage device. This has the advantage that no insulating fluid layers can gather there. Especially with a flexible case 9 of the latent heat storage device 7 , which could consist of a plastic foil for instance, a tight adherence between a large area of the case wall and the frozen storage medium can therefore be achieved at all times so that an optimum heat or chill exchange respectively can occur with the air delivered past it. [0042] The liquid accumulator itself serves as a drink reservoir and can be withdrawn from the backpack-type outer case 3 as well as the latent heat storage device 7 through an opening not specifically shown, if required. It is possible to fill it initially with consumable liquid in order to have an adequate drink volume available already at the start of the operation. [0043] Suitable spacers 18 in the form of ledges are provided at the latent heat storage device in the depicted example for the realisation of an adequate air slot between the latent heat storage device 7 and the receptacle 6 for a sufficiently large flow cross section. The receptacle 6 itself is being kept in place inside the backpack-like outer case 3 , which can have a sufficiently solid shape for example, by suitable spacers 19 of for instance a springy type or by the pressure of an air cushion. Or the receptacle 6 adheres to the spacers 18 by way of its elastic characteristics. [0044] Beside the central lower air intake 10 , through which the air to be cooled is taken in and which can be closed by a suitable sealing flap 20 when not in use, a further air intake 21 is evidently provided, through which in the depicted example unchilled air can be taken in by the fan 11 . The air intake 21 terminates directly or via a suitable supply pipe above the latent heat storage device 7 in the area of the air already chilled. In this way additional air can be mixed in. Through the flap-like regulating element 22 in the depicted example the air intake 21 can be opened and closed or its aperture generally can be adjusted respectively. The mixed air is then supplied to the person through the air pipe 13 . [0045] FIG. 2 further depicts the control unit 23 , which shows an integrated power supply 24 for example in the form of rechargeable battery cells or batteries. This will be referred to later. At any rate this is controlling the air conditioning operation. [0046] FIG. 3 shows a further version of an air conditioning unit 1 b in accordance with the invention. Here it is apparent that the latent heat storage device 7 in its lower section, which faces the air intake opening 10 , is distinctly thicker than in its upper section, which faces the air outlet opening 12 . This compensates the different thawing characteristics caused by the temperature difference between the air taken in and the air discharged. This means that the latent heat storage device 7 thaws faster in the lower section, which is being blasted by warmer air, than in the upper section; depicted further in dashed lines is the liquid accumulator 17 , the provision of which is optional as is that of a further liquid storage 25 , which can be placed inside the backpack-like outer case 3 and which in the depicted example can be coupled to the liquid accumulator 17 if required. This liquid storage 25 serves, like possibly the liquid accumulator 17 also, as an initially filled liquid reservoir, from which the person can consume liquid even if no air conditioning operation has occurred yet and therefore no thawed storage medium is available. [0047] FIG. 4 depicts a further version in accordance with the invention, which is essentially equivalent to the version from FIG. 3 . However here a second fan 26 is provided for taking in warmer surrounding air through the additional air intake 21 for mixing. The control unit 23 or the integrated power supply 24 respectively operate this fan 26 also. This air intake too can be closed by a locking flap 27 if required, as is also possible for the air outlet 12 by the locking flap 28 with the air pipe 13 disconnected. Depicted further is the mouthpiece 29 attached to the fluid pipe 14 , which for instance could also serve as plug for the fluid pipe 14 to prevent undesired loss of liquid through dripping. [0048] FIG. 5 finally shows in a basic view the control panel 30 of the control unit 23 , which could for instance be positioned in the freely accessible rear wall of the backpack-like case 3 ; it is equally possible to have it positioned on the side so that the person could operate it with the unit strapped on, if required. [0049] Depicted is the ON/OFF switch 31 , which requires to be pushed to start the air conditioning unit. With this at least the fan 11 will automatically start to draw in air and to produce cooling. Shown further is a not closer defined thermostat 32 , comprising a selector switch 33 , with which a desired temperature indicated in the display 34 , can be selected. The control unit 23 is capable of automatically adjusting the temperature to the desired level, which is governed by the automatic control of the operation of fan 11 for varying the volume of the air taken in or, if installed, of the second fan 26 or the regulating element 22 respectively, through which the aperture of the air pipe supplying the unchilled air can be varied. All required elements are automatically driven to adjust the selected temperature. [0050] Finally a switch 35 is provided, through which the person can for instance manually adjust the regulating element 22 , for temperature control when the thermostat-controlled operation is not desired. Furthermore a switch 36 is provided, with which the speed of fan 11 and the second fan 26 , if installed, can be adjusted in order to vary the blower intensity. This switch 36 can for instance be realized as a combined rotary/press switch to allow switching over from driving the fan 11 to driving the second fan 22 by pushing the switch 36 . The ability to drive both through this is indicated by the symbol “U 1/2 ”. [0051] Further depicted are several solar cells 37 , which aid the power supply. Through them the rechargeable battery cells 38 , which form the power supply, can be recharged continuously. Furthermore, a charging state indicator 39 , for example as a LED, for the power supply and an equivalent charging state indicator 40 for the latent heat storage device are provided. [0052] The invention is not limited to the versions described. It is possible for instance to realize the case 3 also as a waist or hip bag, which is to be worn like a belt and therefore designed a little smaller. The version in the form of a shoulder bag is also conceivable. Furthermore it is possible to provide instead of the air pipe 13 as shown in the drawings, one that has at its end a clearly expanding outlet segment, which is equipped for example with outlet jets of different radial direction, through which the chilled air can be blown out. This flat outlet segment for example can be pushed under the clothing so that the body can be cooled. It needs to be pointed out eventually that for the operation of the thermostat suitable sensor elements for registering the relevant parameters like actual temperature at the air outlet, speed of the fan or fans if necessary and also the position of the regulating element can be provided. Adequate, preferably electrical adjustment means for varying the position of the regulating element 22 in the form of a small electric motor or equivalent are provided in addition, naturally. However a mechanical motion coupling with the switch 35 is also conceivable. [0053] Finally there is the option to utilise the personal air conditioning unit not as a combined cooling and drink reservoir unit but as a warming device, combined with the drink option. This will be useful for instance when the unit is being employed in a very cold environment. In this case it is conceivable to fill the latent heat storage device (or possibly a further additional latent heat storage device) with a hot and consumable storage medium, which serves to warm the air delivered past it. When the storage medium cools in the course of the warming operation as the result of the heat exchange, the liquid can be extracted and consumed. It is conceivable for example to fill it with hot water or hot tea or any other hot drink. Although the heat storage capacity or respectively the introducible energy content of the hot storage medium is evidently lower than that of the frozen storage medium, it is nevertheless possible to achieve warming of the air over a longer period of time, which will be appreciated by the user. In this version the separate liquid accumulator option is obviously not required since the storage medium presents in its liquid form anyway. Nevertheless all other invention versions, which have been described in the earlier specifications for the use as a cooling device, have to be provided appropriately in this case also. [0054] As an alternative to the use of the described unit as a heating device by employing an also consumable storage medium, the option exists in the way of an air conditioning system to provide a further latent heat storage device, which can be placed inside the receptacle if required due to the interchangeability, and which contains a heat-storing, non-consumable medium such as a wax-like medium for example. This could for instance be heated in a microwave oven or a stove or equivalent and be placed in the receptacle in a hot state. In this way the personal air conditioning system can equally be used as a heating device for warming the air, although in this case the drink option is not available. This could be possible if for instance a separate liquid storage would be provided or if the liquid accumulator, which in this version would not be required, would initially be filled with a consumable liquid. In this version however the liquid accumulator is not coupled to the latent heat storage device. In this way the possibility exists to realize a warming of the air, because of the use of a wax-like substance for a clearly longer period of time. Such an additional latent heat storage device could for example be bought as an aftermarket accessory to the personal air conditioning unit in accordance with the invention. [0055] As no extraction of the storage medium occurs in this case, a refilling of this latent heat storage device is not required. In this case too the personal air conditioning unit displays all the characteristics described in connection with its use as a cooling device.

1a

BACKGROUND OF THE INVENTION Needle-free injectors are used as an alternative to needle-type hypodermic injectors for delivering liquid drugs and other substances through the skin and into the underlying tissue. The drug is dispensed by a piston from a drug capsule at pressures high enough to pierce the skin. Typically, the drug capsule will comprise a hollow cylindrical chamber narrowing to a discharge orifice at one end, with the piston slidingly and sealingly located at the other. The piston is driven towards the orifice to dispense the drug by a dispensing member. Typically devices are powered by a variety of means, such as a spring (the spring force being supplied by a resilient element or a pressurised gas) or pyroteclmic charge. Examples of such devices are described in U.S. Pat. Nos. 5,891,086 and 5,480,381 For spring powered needle-free injectors, the spring constantly exerts a force on the dispensing member prior to use and a restraining means is required to prevent the dispensing member from moving under the force of the spring. The needle-free injector is triggered by moving the injector into a condition in which the restraining means no longer has a restraining effect, thus permitting the dispensing member to move. It is often desirable for the triggering of the delivery of the medication to involve a very modest force, for example by the patient pressing a button or pressing the injector against the injection site. However, this low force can cause premature triggering, such as when the device is dropped, or when the cap over the injection orifice that maintains formulation stability and sterility on storage is removed. A problem exists during the assembly of such devices-producing a device which is easy to operate, may result in a device which is also easy to accidentally trigger during manufacture and assembly. This is both wasteful and can be a safety hazard to the personnel involved. WO 97/37705 addressed this issue by providing a device for dispensing a material or article, which comprises a spring, which provides an energy store, a dispensing member movable to effect dispensing under the force of the spring, latch means having a first position which prevents triggering of the device, a second position in which it restrains movement of the dispensing member but enables triggering, and a third position in which it permits such movement, trigger means operable by the user for moving the latch means from said second position to said third position, the first position being a safety mechanism effective before the device has been completely assembled to prevent movement of the latch means to the third position. For the embodiments of the inventions disclosed in WO 97/37705, the safety mechanism is disengaged at the end of the assembly process, using a tool inserted into the device to move the latch from the first position to the second position, with the latch being restrained from moving to the third position by an outer-ring. The triggering means, which functions by moving the latch so that it is no longer restrained by the outer-ring, is then restricted from operating by a tear-off band, which physically stops the movement of the latch with respect to the outer ring, the band being removed prior to triggering the device. As an alternative to the above, it may be advantageous to store the devices in the first position, with the original safety mechanism engaged. The devices are stored for up to three years before use and from both a general safety and device performance perspective there are advantages to keeping the safety mechanism engaged. Then following storage, just prior to triggering, an attachment to the device is used to disengage the safety mechanism. In addition, the orifice must be kept sealed during storage to ensure stability and sterility of the drug product. The removal of the orifice seal is preferably combined with the disengagement of the safety mechanism, to ensure the system is easy to use, and to ensure that the orifice seal is removed prior to the disengagement of the safety mechanism, so that it is not possible that the act of removing the orifice seal triggers the delivery of the drug. SUMMARY OF THE INVENTION According to the present invention, there is provided a device for readying a needle free injector for delivery. The injector comprises a energy store, such as a pyrotechnic charge, a mechanical spring, or preferably a pressurized gas spring, and a dispensing member movable, to effect dispensing, under the force of the spring. The invention provides a cap comprising a seal covering the injection orifice to ensure stability and sterility of the contents, and a mechanism for removing said cap. The invention also provides a mechanism for changing the state of the device from a safe state to a ready to deliver state. The safe state is characterized by an inability to accidentally deliver the contents, when for example, the device is dropped, the cap is removed, or the device is otherwise affected. The invention also provides for a linkage between the two mechanisms, such that they must be completed in the correct order, ie the cap is removed while the device is in the safe state. It is preferred that the act of removing the cap and placing the device in the ready to deliver state be accomplished in a single motion, for example by (but not limited to) having a lever, the end of which is attached to the cap, and the base of the lever actuating the safety mechanism. However, it could also be accomplished in two motions, for example wherein the removal of the cap exposes a safety mechanism which is subsequently actuated by the user, or alternatively wherein the cap is removed, exposing the end of the lever to allow the lever to be pivoted, placing the device in the ready to deliver state. In one embodiment, the removal of the cap and the placing of the device into the ready state exposes a button, said button being pushed by the user to deliver the contents. However, it is preferred that the act of pressing the delivery orifice against the delivery site is what triggers the device to deliver. An advantage of the invention is that the cap keeps the contents sterile until the delivery It is another advantage of the invention that the cap maintains the stability of the contents, especially to evaporation. It is another advantage that the device keeps the injector in the safe state until it is ready to deliver. It is another advantage that the device ensures that the injector is in the safe state until after the cap is removed, to ensure that the act of removing the cap does not lead to accidental delivery, by for example, accidentally pressing on a trigger button or accidentally pressing the end of the injector in a way that mimics pressing the injector into the skin, causing premature delivery. These and other advantages will be readily apparent to those skilled in the art. In the preferred embodiment, the invention provides a latch means having a first position wherein the device is safe, and cannot trigger until the latch is forcibly moved. The latch also has a second position, which it restrains movement of the dispensing member, a third position which releases the device to cause delivery, and a trigger means operable by the user for causing the latch means to move from said second position to said third position. Moreover, there is provided a second safety mechanism which engages and disables the trigger until after the cap has been removed and as the device is placed into the ready to trigger state. The invention is linked such that it cannot be activated to move the latch from the first to the second position or disengage the second safety mechanism until the cap providing a sterile barrier to the formulation within drug capsule has been removed. These and other objects, advantages, and features of the invention will become apparent to those persons skilled in the art upon reading the details of the embodiments as more fully described below. BRIEF DESCRIPTION OF THE DRAWINGS The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures: A number of different embodiments of the invention are described in the following section making reference to the accompanying drawings, in which: FIG. 1 presents a longitudinal cross-section through the preferred embodiment of the invention; FIGS. 2 a, b and c show the latch 6 and dispensing member 2 part of the injector from FIG. 1 in the three stages ending in triggering. In (a) the latch 6 is in the first, or safe position. In (b) the latch 6 is in the second position, the non-safety, ready to trigger position. In (c), the latch 6 is in the third position, following triggering; FIG. 3 illustrates a needle free injector with one embodiment of the attachment for disengaging the safety mechanism; FIGS. 4 a and b show the latch 6 , dispensing member 2 and collar 33 components of FIG. 3 with the latch 6 in the first, safe position (a) and the second, ready to trigger position (b) respectively; FIGS. 5 a and b present end on views of the device in FIG. 3 showing a second safety mechanism comprising block sections, with the (a) the block sections 38 engaged and (b) the block sections 38 disengaged; FIGS. 6 a, b and c illustrate another embodiment of the attachment for disengaging the safety mechanism (a) with the outer cap 31 in place, (b) with the outer cap 31 inverted to cover the seal carrier 20 and (c) with the seal carrier 20 snapped off by applying pressure to the outer cap 31 . FIGS. 7 a, b, c present the third embodiment of the attachment for disengaging the safety mechanism (a) with the outer cap 31 in place, (b) with the outer cap 31 removed, removing the seal carrier 20 and (c) on rotating the ring section 39 . FIGS. 8 a and b present a cross-section view of the injector in FIG. 7 showing a) the safe position and (b) the ready trigger position; and FIG. 9 shows the needle-free injector as shown within FIG. 3 but with the button firing mechanism. DETAILED DESCRIPTION OF THE INVENTION Before the present device and method are described, 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. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention. 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. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. 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 storage means” includes a plurality of such storage means and reference to“the spring” includes reference to one or more springs and equivalents thereof known to those skilled in the art, and so forth. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. The embodiments of the invention disclosed are based on Aradigm's (formerly Weston Medical's) Intraject needle-free injector, described in WO 95/03844. FIG. 1 presents a longitudinal section through the Intraject needle-free injector prior to integration with the device of the present invention. In FIG. 1 , the injection force is provided by a compressed gas spring, which comprises a cylinder 1 enclosed at one end containing a gas, typically nitrogen, typically at a pressure between 150 and 300 bar. Contained within the cylinder is a dispensing member 2 . The end of the dispensing member has a frusto-conical, truncated cone-portion 3 and a flange 4 . There is a double o-ring seal 5 situated between the truncated cone section 3 and the flange 4 . Prior to triggering the device, the dispensing member 2 is held in the position illustrated in FIG. 1 by a latch 6 which sits in a groove in the dispensing member. The upper surface of the groove forms a cam surface 7 . Consequently, there is force urging the latch to move to the left. In the configuration shown in FIG. 1 , the latch is restricted from moving by the outer ring 8 . At the lower end of the cylinder 1 , there is an outwardly directed flange 9 . The cylinder is held in place by crimping the flange 9 to another outwardly directed flange 10 on the upper end on a coupling 11 . The sleeve 8 consists of an upper sleeve portion 12 within which the cylinder is situated, and a lower sleeve portion 13 . The lower sleeve portion 13 is connected to the coupling 11 by inter-engaging screw threads 14 formed on the inner and outer walls of the lower sleeve portion 13 and the coupling respectively 11 . The injector has a cartridge 15 which contains the medicament. In the cartridge there is a piston 16 , slidingly and sealingly located therein. The piston 16 may comprise a cylindrical portion containing two larger diameter ribs, and a frusto-conical portion. The piston 16 is in contact with the medicament 17 and at the other end of the cartridge 15 there is a discharge orifice 18 . Adjacent to the orifice 18 there is an interface seal 19 contained within a seal carrier 20 . The interface seal 19 is required for filling the needle-free device as described in PCT/GB9700889. A stopper 20 a seals the medicament into the capsule. Seal 19 , seal carrier 20 , and stopper 20 a , comprise the cap that must be removed prior to delivery. To place the device in the ready to deliver state, the cap must be snapped off at the frangible joint 21 . This removes the seal 19 and exposes the orifice 18 . The trigger blocking mechanism 22 , which prevents the medication cartridge from moving back toward the upper sleeve portion 22 , thereby preventing delivery, is removed. Finally, latch 6 must be moved from the first (safe) position, to the second (ready to deliver) position, The latch 6 is incorporated into a groove in the dispensing member 2 —not only does the groove have a cam surface 7 but also a locking surface 27 which is perpendicular to the dispensing member axis and is located radially inward of the cam surface 7 . Additionally, to access the latch 6 there is an opening 28 in the upper sleeve 12 , which prior to triggering is aligned with the latch 6 . FIGS. 2 a, b and c illustrate the operation of the safety mechanism. When the latch and dispensing member are initially assembled, the latch occupies the first (safe) position, as shown in FIG. 2 a . In this position, the dispensing member-engaging latch portion 29 is acted on by the locking surface 27 . Frictional force ensures that the latch is held rigid by the locking surface—typically the dispensing member exerts a force of at least 100N. The latch is placed in the second (ready to deliver) position using a pin which fits through opening 28 to push the latch in the direction of the arrow P into the position shown in FIG. 2 b , (and in FIG. 1 ). In this position the dispensing member engaging latch portion 29 is in contact with the radially inner end of the cam surface 7 . To cause delivery, the orifice 18 is then placed against the skin of the patient. Practically, this involves holding the device by the upper sleeve 12 portion. The upper sleeve 12 is then moved downwards with respect to the lower sleeve 13 , bringing aperture 25 in the wall of the upper sleeve portion 8 into alignment with the latch 6 . The latch then moves to the left into the aperture 25 , under the force exerted on it by the cam surface 7 formed in the dispensing member 3 into the position shown in FIG. 2 c . The injector then delivers. It is advantageous to have a mechanism that places the device in the ready to deliver state in a simple motion or motions. FIG. 3 illustrates one embodiment of the combined needle-free injector plus means for disengaging the safety mechanism 30 . In this Figure, the means for disengaging the safety mechanism consists of a cap 31 enclosing, and holding rigidly, the seal carrier 20 , a lever 32 and a collar 33 . The lever 32 and collar 33 are presented in more detail in FIGS. 4 a and 4 b . The lever contains a lip 34 at the far end, over which the cap 31 is positioned. This ensures that the lever 32 cannot be moved before the outer cap 31 is removed, which in turn ensures that the user cannot move the latch or disengage the safety mechanism until the cap has been removed. The lever 32 is pivoted around the pivot axis 35 , with the pivoted surface in contact with injector being a cam surface 36 . The force required to pivot lever 32 is in the range from about 2N to about 30N. The collar 33 contains a pin 37 which extends into the device through the opening 28 in the upper sleeve 12 to impinge on the far side of the latch 6 , see FIG. 4 a . The force required to move the latch is in the range from about 20N to about 120N. To stop the upper sleeve section 12 moving with respect to the lower sleeve section 13 , there are block sections 38 between the upper and lower sleeves, which form part of the collar 33 . The relative position of the block sections 38 with respect to the lever 32 is more clearly presented in the end-on view of the device shown in FIG. 5 a. To deliver the device contents, the cap 31 is removed, exposing the injection orifice 18 . With the outer cap 31 removed, the lip 34 is exposed, enabling the lever 32 to rotate about the pivot axis 35 . Only when the outer cap 31 is removed can the lever 32 be rotated. As the lever 32 rotates, the cam surface 36 forces the collar 33 to move in the direction Q in FIGS. 3 , 4 a and 5 b pushing the pin 37 against the latch 6 . When the lever 32 has rotated through a complete cycle, approximately 180° as shown in FIG. 4 b , the latch 6 moves to the second position, as shown in FIG. 2 b . The blocks 38 no longer restrict the movement of the upper sleeve 12 with respect to the lower sleeve 13 and the device can trigger as described above. The relative movement of the block 38 with respect to the sleeve section 12 and 13 is seen in the end on view presented in FIG. 5 b . By integrating the cap 31 to the lever 32 with a flexible joint at the tip 34 , the mechanism can also be configured to ensure that the user removes the stopper and sets the safety in a single action. FIG. 9 shows an alternate embodiment from FIG. 3 wherein rather than using the blocks 38 , the movement of the lever 32 exposes a trigger button 42 , the trigger button 42 subsequently being pressed by the subject to delivery the medication. Another embodiment of the invention is shown in FIGS. 6 a, b and c . In FIG. 6 a the as-received device is presented. To operate the device the outer cap 31 is removed, leaving the seal carrier 20 intact. The outer cap 31 is then inverted and placed back over the seal carrier 20 , as shown in FIG. 6 b . Pressure is then applied to the outer cap 31 to break the frangible seal between the seal carrier and the lower sleeve, as shown in FIG. 6 c . The device is then placed in the ready to deliver state by rotating the lever 32 as described above and presented in FIGS. 4 a and b. A third embodiment of the invention is shown in FIGS. 7 a, b and c . This version of the attachment for disengaging the safety mechanism consists of an outer cap 31 covering and holding rigid the seal carrier 20 —not shown in FIG. 7 a -, a collar section 39 and a barrel section 40 . The needle-free device fits within the barrel section 40 upper sleeve portion 12 first, so that the longitudinal axis of the device is aligned with the longitudinal axis of the barrel section 40 . The needle-free device is held rigidly within the barrel section 40 . The collar section 39 fits over and is attached to the barrel 40 , so that the collar section 39 is free to rotate about the axis of the device in a clockwise direction when the outer cap 31 has been removed. The outer cap 31 contains a locking mechanism 41 which locks the collar 39 rigid when the cap 31 is in place. To trigger the device the outer cap 31 is removed, which in turn removes the seal carrier 20 , exposing the injection orifice 8 . The collar section 39 is now free to rotate clockwise about the axis of the needle free device. Because the cap 31 is locked into the collar section 39 , this ensures that the user cannot move the latch or disengage the safety mechanism until the cap has been removed so forcing the user to prepare the device in the correct order. There is a lip 42 on the collar section 39 , which is aligned so that the lip fits under the lip of the tear-off band 22 . As the collar section rotates clockwise the tear-off band 22 is torn off, so that after a complete revolution, 360°, the tear-off band 22 is completely removed. Simultaneously the safety mechanism is disengaged. This is illustrated by the cross-sections through the collar section shown in FIGS. 8 a and b . In FIG. 8 a the safety mechanism is engaged—that is the latch is in the safe position shown in FIG. 2 a . On the inside of the collar section there is a pin 37 which extends into the device through the opening 28 in the upper sleeve 12 to impinge on the far side of the latch 6 . The pin is in contact with the inner surface of the collar section. The inner surface of the ring section is a cam surface 43 , so that as the collar rotates the action of the cam surface pushes the pin against the latch moving the latch from the safe position to the first position as shown in FIG. 8 b . With the tear-off band 22 removed, the device can deliver as outlined above. The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims.

1a

BACKGROUND [0001] 1. Field of Invention [0002] This invention relates to compositions of matter used as sources of vitamin C in dietary supplementation, skin care products, therapy, research, and manufacturing. More specifically, the invention relates to stable liquid compositions containing the oxidized form of vitamin C known as dehydroascorbic acid. [0003] 2. Prior Art [0004] Ever since the elucidation of the chemical structure of vitamin C in the mid-1930's it has been known that vitamin C occurs naturally as two different compounds, namely, ascorbic acid (AA) and an oxidized form of AA called dehydroascorbic acid (DHAA). It also is known that AA and DHAA are unstable compounds. In aqueous solutions, some factors which affect the rate of their destruction include the pH of the solution, and exposure to various metal ions, heat, light and air. It also is known that DHAA is considerably less stable than AA when subjected to comparable conditions. ‘Deutsch J C. Dehydroascorbic acid. Review Journal of Chromatography A, 881 (2000) 299-307 ’ (Deutsch), incorporated here by reference, states en-equivocally “DHA is more reactive and unstable in solution than AA.” Therefore, as a supplement to the diet, or as an ingredient of a topically applied product such as a skin lotion, AA has been the preferred chemical form of vitamin C because of its greater stability. In fact, we do not know of any commercially available dietary or topically applied product wherein DHAA specifically has been utilized as a substantial source of vitamin C. [0005] Also known is that solid AA is far more easily dissolved in water than is solid DHAA, as noted in ‘Pecherer B J. The Preparation of Dehydro-L-ascorbic Acid and its Methanol Complex. Am Chem Soc 73 (1951) 3827-3830’ (Pecherer) and ‘Koliou E K and Ioannou P V. Preparation of dehydro-L-ascorbic acid dimer by air oxidation of L-ascorbic acid in the presence of catalytic amounts of copper(II) acetate and pyridine. Carbohydrate Research 340 (2005) 315-318 ’ (Koliou) which are incorporated here by reference. To prepare aqueous solutions of DHAA from the solid form requires prolonged mixing at temperatures well above 37 degrees centigrade. Thus solutions of DHAA are much more difficult to manufacture than solutions of AA. Also, since the conditions to solubilize it efficiently do not exist in the gut of human or other animals, substantial doubt exists about whether the dry, solid form of DHAA can be absorbed when ingested. These are also reasons why DHAA has not been utilized as the source of vitamin C for dietary supplements or topical products. [0006] Around the same time as the chemical structures of AA and DHAA were elucidated in the mid-1930's, the antiscorbutic properties (ability to prevent the disease called scurvy) of both compounds were recognized and generally accepted as being equal or nearly so. The oxidation of AA to DHAA was shown to be reversible both in vitro and in biological systems, so the equivalence of the two compounds could easily be attributed to simple interconversion within an organism. Although a few early investigators did note some peculiar differences in the biological utilization of these two compounds, at least as essential dietary ingredients for humans and certain other species, AA and DHAA were generally considered bioequivalent. The dietary supplement and skin care product industries developed their products using AA (and various more stable derivatives of AA) because of the stability and solubility issues with DHAA, and DHAA has essentially been ignored and forgotten in these industries. [0007] Since the mid-1930's, the volume of research in vitamin C has been enormous, and it is possible that no single subject in the field of biology has been the focus of more research and more scientific journal articles than vitamin C. And since about the mid-1990's, many new discoveries about DHAA have been made. Among these discoveries, those of particular pertinence to the present invention include those which demonstrate that, although the two compounds are equivalent in their antiscorbutic properties, AA and DHAA are not “bioequivalent” in any broad definition of the word. Specifically it is known today that AA and DHAA are absorbed by different mechanisms in the gut; that they accumulate differently in the various tissues of an animal when ingested; that they are absorbed into living cells by completely different mechanisms utilizing different receptors on the cell surface; that the cells of certain important tissues of the human body (e.g., brain) have a very high concentration of vitamin C but completely lack cell surface receptors for AA; that DHAA is absorbed into cells by the same receptors as glucose, which are present on every cell in the human body; that in human skin cells, DHAA is absorbed up to 5 times faster and to levels 2 times higher than is AA; that DHAA is almost instantly converted into AA once it has been absorbed into a cell; that both AA and DHAA have antiviral effects in vitro against viruses that cause disease in humans such as HSV-1 (herpes simplex virus type 1 that causes oral herpes and can cause genital herpes), influenza virus, and poliovirus; and that DHAA has much stronger antiviral effects than does AA. Literature that supports these statements, and is incorporated here by reference, includes ‘Savini et al. Dehydroascorbic acid uptake in a human keratinocyte cell line (HaCaT) is glutathione-independent. Biochem J 345 (2000) 665-672 ’ (Savini) and ‘Furuya et al. Antiviral effects of ascorbic and dehydroascorbic acids in vitro. Int J Mol Med 22 (2008) 541-545’ (Furuya). [0008] Thus it can be seen that a solution of DHAA for oral ingestion or topical application, while being a source of vitamin C much like numerous other available products that contain AA, also can provide specific benefits and uses unavailable in any other product on the market today. What is needed is a stable liquid solution of DHAA in an orally and topically acceptable medium. [0009] U.S. Pat. No. 5,140,043 (Dan) discloses topical compositions of ascorbic acid (or a reducing analog of ascorbic acid) in a water-(glycol or polyol) carrier, wherein the ratio of water to glycol/polyol carrier is high (e.g., at least 1:1). These solutions of Darr do not contain DHAA, and Darr is silent as to the stability of the non-reducing compound DHAA in this carrier. We have found that DHAA is not stable in polyol solutions containing such high concentrations of water, which points out that no assumptions about the chemical and physical behavior of DHAA in polyol solutions should be drawn from the behavior of AA in those solutions. While AA and DHAA share certain biological functions, they are two different molecules in regard to their physical and chemical behavior, including stability. [0010] U.S. Pat. No. 6,197,813 (Hegenauer) discloses stable vitamin C compositions of mineral ascorbates in liquid organic polyol solvents having pH values of about 5 to 7, but is silent as to the stability of the non-mineral DHAA in those solvents. These compositions of Hegenaur do not contain DHAA. In fact, these compositions do not even contain a naturally-occurring form of vitamin C, and therefore if these compositions were applied to the skin, vitamin C would not be expected to be absorbed by either the ascorbic acid receptors or the glucose receptors of skin cells. [0011] US Patent Application 2009/0016974 A1 (Pruche et al) discloses DHAA-containing compositions formed “in situ” from ascorbic acid via chemical oxidation and/or via enzymatic oxidation, and a two-component agent thereof. These compositions attempt to overcome the instability of DHAA by preparing it fresh as needed, but they require handling and mixing steps of the two-component agent. The two components must be stored separately. Chemical oxidizers are harsh and can be dangerous, and enzymes are unstable, thus these compositions are problematic in regard to safety and reliability. Since the two components are intended to be combined by the end user, the temperature of the reaction and other conditions necessary for reliable oxidation processes are beyond the control of the manufacturer. Without some separate indicator, the final consumer cannot be assured that the solution prepared by the two-component system actually contains DHAA, because the oxidation of AA to DHAA is not visually or otherwise simply detected. These compositions do not contain DHAA pre-prepared in a stable solution, and Pruche et al is silent as to the stability of DHAA in the disclosed compositions. OBJECTS AND ADVANTAGES [0012] Several objects and advantages of the present invention are: a. To provide compositions containing DHAA in a stable form. b. To provide stable DHAA-containing compositions for topical application to the skin of a human or animal as a source of highly absorbable vitamin C. c. To provide compositions for topical application that are pharmacologically acceptable and pleasant to use. d. To provide compositions for topical application that can be applied alone, or mixed with water to provide greater humidifying effect, or mixed with another skin care product to enhance the vitamin C content of that product. e. To provide compositions containing DHAA for topical application that can also solubilize other skin-enhancing substances that are insoluble in water, such as vitamin E. f. To provide stable DHAA-containing compositions for dietary supplementation of a human or animal as a source of highly absorbable vitamin C. g. To provide compositions for dietary supplementation that are pharmacologically acceptable and pleasant to use. h. To provide compositions for dietary supplementation that can be taken orally alone, or mixed with water or some other liquid, or applied to solid food. i. To provide stable DHAA-containing concentrates for manufacturing of other products. j. To provide stable DHAA-containing compositions that can be conveniently used in research, for example in chemical studies, or in microbial culture or tissue culture. k. To provide stable DHAA-containing compositions that do not require the addition of chemical stabilizers or preservatives. DRAWING FIGURES [0024] FIGS. 1 to 8 show the DHAA stability of the various compositions described in Example 1 as compared with DHAA prepared similarly in water. [0025] FIG. 9 shows the DHAA stability of the composition described in Example 2 as compared with DHAA prepared in water. [0026] FIGS. 10 to 15 show the DHAA stability of the compositions described in Example 3 as compared with DHAA prepared similarly in water. DESCRIPTION [0027] We have discovered that DHAA is stable in solutions of pure polyol solvents and in solutions wherein the polyol content is greater than about 50 percent. By “stable” is meant that DHAA in these solutions deteriorates very slowly over a sufficient period of time that it can be stored and sold as a dietary supplement or as a skin care product, or as a concentrate for preparing or manufacturing them, with a reasonable shelf life. The solutions are made by oxidizing ascorbic acid that is first dissolved in a pure polyol solvent, or in water, or in some mixture of these liquids. The polyol concentration may be adjusted to about 50% or greater prior to oxidizing the AA or afterwards. [0028] The solutions can also be made by oxidizing AA that is dissolved in an alcohol (e.g., ethanol), and then combining the DHAA-containing alcohol with a polyol solvent. If it is desired that the final solution does not contain alcohol, the alcohol can be removed by evaporating the alcohol from the polyol solvent solution using heat or vacuum, or both. [0029] The solutions can also be made by dissolving solid DHAA in a pure polyol solvent, or in water, or in some mixture of these liquids. The polyol concentration may be adjusted to about 50% or greater prior to dissolving the DHAA or afterwards. [0030] The organic polyol solvents are chosen for pharmaceutical and dietary acceptability, their ability to solubilize the AA and DHAA component, water content, and effect on the stability of the DHAA component. At present we prefer to employ commercially available glycerol which generally contains 5% or less water. In general, we prefer to minimize the water content of the solvent(s), consistent with economic and functional considerations. Other polyols which can be employed include propylene glycol, hexylene glycol, butylene glycol and the almost infinite molecular weight range of polyethylene glycols, as well as so-called sugar alcohols, e.g., sorbitol and xylitol, and mixtures thereof with other polyols. [0031] These solutions can be prepared entirely with one polyol solvent, e.g., glycerol, or mixtures of polyol solvents. The final choice of solvent will depend on economics and other relevant factors. [0032] Methods we have successfully applied for oxidizing the ascorbic acid include the use of halogen or ozone or oxygen/activated charcoal or Fenton's Reagent or ascorbic acid oxidase enzyme. All of these methods are known in the art, as are other methods; the previously cited references Pecherer and Koliou show typical applications of various methods for example. The method by which the oxidation is accomplished is not the determinant factor of the long term stability of the DHAA in the solution, and other methods of oxidation are within the scope of the invention. [0033] AA concentration in solution is commonly measured as the reducing activity of the solution using starch-iodine titration methods that are well-known in the art. AA is also measured by ultra-violet spectrophotometry using a wavelength at which AA absorbs strongly and DHAA does not, typically about 265 nm. This method is also well known in the art. DHAA in solution can be converted into AA by reducing agents such as dithiothreitol (DTT) or tris(2-carboxyethyl)phosphine (TCEP), and its concentration is commonly measured spectrophotometrically as the difference in absorbance of a solution subjected to reduction by DTT or TCEP versus a similar solution that is not subjected to a reducing agent. These methods are also well-known in the art, but see Deutsch for examples. In the description, claims, and the following examples, DHAA in the compositions of the invention is the vitamin C that can be measured by the difference in absorbance at 262 nm using TCEP reducing agent. [0034] The following embodiments are exemplary of the invention: Example 1 [0035] In a preferred embodiment of the invention, AA dissolved in glycerol and/or water is oxidized using ozone to produce DHAA solutions. Water-based solutions and glycerol-based solutions may be combined to yield stable DHAA compositions having the desired polyol concentration. [0036] A 15% AA solution in water was prepared by adding 15 grams AA per 100 mL purified water with stirring. A 15% solution of AA in glycerol was prepared by adding 15 grams AA per 100 mL pure USP glycerol and stirring with heat. A corona-discharge type ozone generator with feed-gas of pure oxygen was used to supply an oxidizing gas containing about 5% ozone, and each of the 15% AA solutions was subjected to oxidizing conditions by bubbling the oxidizing gas through the solution using a glass diffuser. The progress of AA oxidation in each solution was monitored by the disappearance of reducing activity as measured by starch-iodine titration. Each solution was subjected to the oxidizing conditions until all (>99%) of the original reducing activity had disappeared. The solution made with pure glycerol was labeled “100% Glycerol,” and the solution made with purified water was labeled “100% Water.” Portions of these two solutions were combined to produce solutions of various glycerol concentrations by weight, specifically “99% Glycerol,” “98% Glycerol,” “97% Glycerol,” “96% Glycerol,” “95% Glycerol”, “90% Glycerol,” and “50% Glycerol.” For example, 99 parts by weight of “100% Glycerol” was combined with 1 part by weight “100% Water” to produce the “99% Glycerol” solution. [0037] Aliquots of each of the solutions prepared above were placed in translucent, screw-capped polyethylene vials and were stored at room temperature. No attempt was made to further protect the vials from ambient indoor light, and each vial contained a headspace of normal air. Each vial was periodically opened to remove a sample for stability testing over the next 229 days. The concentration of DHAA in each sample was measured by spectrometry on each testing day. The initial DHAA concentration of each solution on Day 1 was recorded and assigned a value of 100%, and the concentration on each subsequent stability test day was calculated as the percent remaining of the initial concentration. [0038] FIGS. 1 through 8 show the results of stability testing of the various glycerol-containing solutions; each graph also shows the result of the “100% Water” solution for comparison. It can be seen that DHAA decomposes rapidly in water. By the time the water solution was tested at 20 days, less than 10 percent of the initial amount of DHAA remained. By contrast, DHAA is preserved very well in solutions containing high concentrations of glycerol. In pure glycerol for example, greater than 80% of the initial DHAA concentration remains even after approximately 8 months of storage at room temperature. As the glycerol concentration is reduced, stability is reduced, until only minor improvement is gained at 50% glycerol concentration. Example 2 [0039] In another embodiment, a stable DHAA composition is produced by oxidation of AA dissolved in glycerol using exposure to activated charcoal and oxygen as the oxidation method. [0040] A solution of AA in pure USP glycerol was subjected to oxidizing conditions by suspending activated charcoal in the solution and then bubbling pure oxygen through the solution. Oxidation of AA during this process was monitored by starch-iodine titration. After the desired amount of AA had been oxidized, the activated charcoal was removed from the solution by centrifugation and filtration. This solution was labeled “100% Glycerol.” A portion of the solution was then placed in a translucent, screw-capped polyethylene vial and was stored at room temperature. No attempt was made to further protect the vial from ambient indoor light, and the vial contained a headspace of normal air. The vial was periodically opened to remove a sample for stability testing over the next 191 days. The concentration of DHAA in the sample was measured by spectrometry on each testing day. The initial DHAA concentration of the solution on Day 1 was recorded and assigned a value of 100%, and the concentration on each subsequent stability test day was calculated as the percent remaining of the initial concentration. [0041] FIG. 9 shows the results of the stability testing of this solution, and for comparison also shows the stability of a DHAA solution prepared in purified water (labeled “100% Water”). It can be seen that DHAA in glycerol produced by an alternative oxidation method shows excellent long-term stability. Example 3 [0042] In another embodiment, stable DHAA compositions are produced by oxidizing AA dissolved in water using Fenton's Reagent as the oxidizing method, and then combining the water solution with propylene glycol such that the final concentration of polyol is 50% or greater. [0043] AA was dissolved in purified water to give a highly concentrated solution, and then sufficient 30% hydrogen peroxide was added to oxidize about half of the AA. Iron to catalyze the reaction was provided by addition of ferrous sulfate. Oxidation of the AA was monitored by spectrometry until the expected amount of AA had been oxidized. This solution was labeled “100% Water.” Portions of this solution were combined with portions of pure, USP grade propylene glycol to produce solutions of “97% Propylene Glycol,” “95% Propylene Glycol,” “90% Propylene Glycol,” “80% Propylene Glycol,” “70% Propylene Glycol,” and “50% Propylene Glycol.” For example, 3 parts by volume of the “100% Water” solution were combined with 97 parts by volume propylene glycol to yield the “97% Propylene Glycol” solution. [0044] Aliquots of each of the solutions prepared above were placed in translucent, screw-capped polyethylene vials and were stored at room temperature. No attempt was made to further protect the vials from ambient indoor light, and each vial contained a headspace of normal air. Each vial was periodically opened to remove a sample for stability testing over the next 31 days. The concentration of DHAA in each sample was measured by spectrometry on each testing day. The initial DHAA concentration of each solution was recorded and assigned a value of 100% (Day 0), and the concentration on each subsequent stability test day was calculated as the percent remaining of the initial concentration. [0045] FIGS. 10 through 15 show the results of stability testing of the various propylene glycol-containing solutions; each graph also shows the result of the “100% Water” solution for comparison. It can be seen that DHAA decomposes rapidly in water; after only 5 days, less than 20 percent of the initial amount of DHAA remains. By contrast, DHAA is preserved very well in solutions containing high concentrations of propylene glycol. In fact, the DHAA concentration in many of these solutions actually increased significantly over time, a remarkable and unexpected discovery. We believe this phenomenon can be explained this way: residual AA continues to oxidize while the DHAA is stabilized and therefore accumulates in the solution. The spectrophotometric measurements support this explanation, but we do not wish to be bound by this explanation. [0046] Example 3 demonstrates that stable DHAA compositions may be prepared using a third alternative oxidation method as compared with the first two examples, and also demonstrates that an alternative polyol solvent can be used. CONCLUSION, RAMIFICATIONS, AND SCOPE [0047] While the above description contains many specificities, these should not be construed as limitations on the scope of the invention, but rather as exemplification of preferred embodiments. The compositions can be prepared using various methods and ingredients as mentioned, and their equivalents. Polyol solvents are known to be antimicrobial in high concentrations and therefore the compositions of the invention generally do not require preservatives. Polyol solvents are also capable of dissolving substances that are not soluble in water, so are capable of solubilizing not only AA and DHAA but additional dietary or skin-enhancing ingredients such as vitamin E. Many polyol solvents are excellent skin-enhancing substances in their own right, such as glycerol which is commonly utilized in skin care products as a humectant. Many polyol solvents are not only safe for ingestion, but in fact have a pleasant, sweet flavor. Thus the compositions have favorable properties that are synergistic with their use as dietary supplements, skin-enhancers, concentrates, or research solutions. Accordingly, the scope of the invention should be determined not by the embodiments illustrated, but by the appended claims and their equivalents.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to retractors and more particularly to surgical incision protectors and internal body organ retraction arrangements which permit an operating surgeon proper open surgical access to the surgical site. 2. Prior Art Incisions made during surgical procedures require sterility of the operating field, maintenance of the incision or wound site against malignant or infectious contamination and peripheral retraction to provide a maximum circular exposure as possible with a minimum incision size. Retraction of various body organs out of the way of the surgeon, the surgical tools and the tissue being treated, is also a consideration during any surgical procedure. Retractors which attempt to do this have been around for a long time. Such retractors may be exemplified by U.S. Pat. No. 1,839,726 to Arnold, showing a circular ring with a plurality of clamps mounted thereon. Such retractors are typically attached to the table on which the patient is lying. The actual blades which comprise the retractors are typically supported by long arms attached to the retractor ring. Such a structure is cumbersome and minimizes the ability of the surgical team to readily move about. Such arrangements are typical even to this day, as may be seen in U.S. Pat. No. 5,520,610 to Giglio et al. The incision itself, as aforementioned, is desirably protected by an incision liner and retractor, as may be seen in U.S. Pat. No. 5,524,644 to Crook and incorporated herein by reference. Such a “sleeve-like” liner and retractor is arranged to fit within the incision, having an O-ring along a lowermost peripheral edge, and a further, somewhat more flexible O-ring along its uppermost peripheral edge of the annular liner. The liner is adjustable by virtue of its being able to be rolled-up about its uppermost O-ring, so as to snuggly engage and hence protect the periphery of the incision. A further retractor and liner is shown in U.S. Pat. No. 5,649,550 to Crook, and incorporated herein by reference, which patent discloses a drape assembly, which is integral with the liner. The O-rings on such a retractor arrangement must of necessity be flexible so as to be folded or bent, so as to be inserted within the incision. The upper O-ring must be flexible and resilient enough so as to permit the sleeve material to be rolled-up about the upper O-ring once the sleeve is to be joined against the incision walls. The retraction force of the O-rings, and particularly the upper O-ring, in certain instances, is insufficient to support retractor blades or provide maximum incision retraction. Also, such a retractor does not provide retraction for internal organs. It is an object of the present invention, to improve upon the retractor assemblies of the prior art. It is a further object of the present invention, to provide a retractor assembly that protects the wound or incision periphery while also permitting the attachment of blade retractors into the surgical site of the patient. It is still yet a further object of the present invention to provide an apparatus which will provide rigidity to the uppermost end of a flexible sleeve mated within an incision, while also providing a platform for the suspension of surgical tools and wound treatment apparatus. BRIEF SUMMARY OF THE INVENTION The present invention comprises an adjustable surgical wound protector and incision retractor (protractor) and stiffener ring support arrangement. The protractor comprises a flexible sleeve of thin material, impervious to solids or fluids containing bacteria and other contaminants. The flexible sleeve has an opening at each opposed end thereof, having a first or a lower O-ring at a first end, and a second or upper O-ring at its second end. The portion of the sleeve extending above the wound incision is rolled about the upper or second O-ring, to reduce the longitudinal dimension of the sleeve into a tight contiguous engagement with the sides of the wound incision. In the first preferred embodiment of the present invention, a protractor stiffening ring is placed about the wound periphery, according to the size of the particular incision. The rolled-up uppermost portion of the protractor sleeve is inserted within a channel of the protractor stiffening ring. The protractor stiffening ring comprises an inner flange, a base portion, and an outer flange, which defines the channel into which the rolled-up outer ring is inserted. The channel thus may comprise an interrupted or continuous annular trough defining the periphery of the surgical site. A lip extends radially outwardly from the uppermost edge of the outer flange, to define a support surface for a movable blade-receiving adapter. The peripheral lip has a peripheral edge on its outermost side having a plurality of notches thereon. The movable blade adapter comprises a cylindrically-shaped housing for receipt of a portion of a paddle or blade arm. The paddle or blade arm extends within the opening of the incision on the radially inside of the sleeve. The blade arm has an elbow portion which extends through the movable blade adapter, for engagement therewithin. The adapter has an innermost lip and an outermost tab, for secure engagement within the notches on the peripheral edge of the lip base. Thus, once the protractor sleeve is fully wound up and snuggly engaged within the channel of the protractor stiffening ring, one or more movable blade adapters may be secured to the top side of the stiffening ring, and retractor blades or paddles may be juxtaposed therewithin to hold body organs out of the way of the surgical procedure during the treatment of the patient. A further embodiment shows an L-shaped retractor ring defined by an annular base having an inner flange extending upwardly therefrom. A blade support station may be arranged at various spaced-apart locations about the periphery of the annular base of the L-shaped protractor ring. The upper end of each blade support station has an opening therethrough in radial alignment with the longitudinal axis of the sleeve about which it is disposed. A retractor blade or paddle, is arranged within the sleeve, and has an uppermost arm and elbow portion which extend s through the opening of each blade support station. The sleeve and O-ring, are mated above and below the incision in the patient's abdomen as in the aforementioned embodiment. The sleeve is wound up above about the uppermost O-ring as in the aforementioned embodiment, the wound-up sleeve and upper O-ring mating in with the space between the blade support stantions and the inner flange of the annular base. Frictional engagement between the blade support stantions and the inner flange provides the tautness of the sleeve. The retractor ring provides the stiffness, as in the aforementioned embodiment, to the assembly, for support of the retractor blades and the paddles in a circular pattern about the edge of the incision. In yet a further embodiment of the stiffening ring, an L-shaped base and flange ring is arranged so as to fit about the periphery of an incision or wound site in a generally circular manner. The upper end of the sleeve and upper O-ring is rolled and fitted into the corner of the L-shaped ring for retention thereof and maintenance of the generally circular configuration of the sleeve and incision of the wound site. A further embodiment of the retractor arrangement of the present invention comprises the annular stiffener ring having an annular base portion, similar to the aforementioned embodiment. However, a flexible resilient torroidally shaped chamber is attached to the lower side of the annular base. This torriodally shaped chamber provides an airtight fit between the stiffening ring and the peripheral surface of the abdomen incision about which the retainer ring is placed. The torroidally-shaped chamber may be filled with a resilient material or pressurizably actuated by a fluid pumnpable therewithin. The outermost flange may have a notch circumferentially spaced around its outermost surface, so as to receive an O-ring for sealing purposes. A cover or dome m ay be arranged so as to snap over the outermost flange of the stiffener ring to provide containment, security and cleanliness for the surgical site. The cover or dome may have an instrument opening therein, to permit laparoscopic surgical procedures to be performed within that site. The stiffener ring in this embodiment also contains an annular trough, as in the earlier embodiment, so as to permit the first or uppermost end of a sleeve to be rolled up and inserted within that channel. Thus what has been shown are a number of embodiments of stiffener rings, to provide an oddity to a protractor sleeve so as to both protect the periphery of the incision or wound site as well as to provide a base for support of retractor blades or paddles to hold organs in place or aside during a particular surgical procedure. The invention thus comprises a surgical wound protector apparatus for the protective support of an incision and support of surgical apparatus utilized within the incision, comprising: a flexible resilient wound liner sleeve having an open upper end and an open lower end; and a rigid annular ring arranged to securely receive the upper end of the resilient sleeve when the sleeve the ring are applied to an incision of a patient. The ring includes a channel for receipt of said upper end of said sleeve. A retractor blade and arm may be attached to the annular ring. The channel has a retractor blade arm receiver arranged thereon to controllably support the blade thereon when the apparatus in placed about an incision. The rigid annular ring comprises an annular base and an inner upstanding flange. The rigid annular ring also comprises an outer upstanding flange, extending from the annular base. The inner upstanding flange has a securement lip extending radially outwardly from an upper edge thereof. A resilient torroidally shaped chamber may be attached to a lower side of the rigid annular ring to function as a sealant between a wound site of a patient and the rigid ring. A dome shaped cover may be arranged to mate onto a flange of the rigid ring. The rigid ring may include a second flange. The cover has an annular rim, the flange and the annular rim having an O-ring sealingly arranged therebetween. The dome may have a sealable port thereon to permit access of surgical apparatus therethrough. The chamber on a lower side of the ring may be pressurized. The invention also includes a method of supportively protecting a surgical incision comprising the steps of: placing a resilient wound protecting protractor sleeve within the surgical incision; arranging a rigid ring around the surgical incision, the ring having an annular base and a flange upstanding therefrom; rolling-up an upper end of the sleeve so as to tightly engage the incision by the sleeve; and placing the rolled-up portion of the sleeve securely onto the rigid ring for maintenance of the sleeve about the incision. The method may include one or more of the steps of: arranging a retractor blade arm receiver onto the rigid ring; attaching a retractor blade to the receiver on rigid ring to permit the blade to support and maintain body tissue in the patient being treated; placing a dome cover onto the flange of the ring to enclose the wound site of the patient; arranging a sealably openable port in the dome to permit controlled access to the incision site on the patient; attaching a pressurized torroidally shaped chamber onto a lower side of the ring to sealing mate the ring to a patient being treated. BRIEF DESCRIPTION OF THE DRAWINGS The objects and advantages of the present invention will become more apparent, when viewed in conjunction with the following drawings in which: FIG. 1 is a side elevational view, in section, of a wound incision protective sleeve arranged within a stiffener ring at its uppermost end, and a retractor arrangement associated therewith; FIG. 2 is a view similar to that shown in FIG. 1 with a further arrangement of retractor blade or paddle support members arranged thereabout; FIG. 3A is a side-elevational view, in section, of a simple stiffening ring for a flexible sleeve protractor; FIG. 3B is a view of the protractor stiffening ring shown in FIG. 3A with a protractor sleeve arranged about a portion of a wound site; and FIG. 4 is an exploded side-elevational view, in section, of a further embodiment of a stiffening ring having further patient assisting devices therewith. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings in detail, and particularly to FIG. 1, there is shown a preferred embodiment of the present invention which comprises an adjustable surgical wound protector/incision retractor (protractor) 10 and stiffener ring support arrangement 12 . The protractor 10 comprises a flexible sleeve of thin material, impervious to solids or fluids containing bacteria and other contaminants. The flexible sleeve of the protractor 10 has an opening at each opposed end thereof, having a first or a lower O-ring 14 at a first end 16 , and a second or upper O-ring 18 at its second end 20 . The portion of the protractor sleeve 10 extending above the wound incision “I” is rolled about the upper or second O-ring 18 , to reduce the longitudinal dimension of the sleeve into a tight contiguous engagement with the sides of the wound incision “I”. In the first preferred embodiment of the present invention, a protractor stiffening ring 12 is placed about the wound periphery, according to the size of the particular incision “I”, as may be seen in FIG. 1 . The rolled-up uppermost portion 20 of the protractor sleeve 10 is inserted within a channel 22 of the protractor stiffening ring 12 . The protractor stiffening ring 12 comprises an inner flange 24 , a base portion 26 , and an outer flange 28 , which defines the channel 30 into which the rolled-up outer ring 18 and sleeve 10 is inserted. The channel 30 thus comprises an annular trough defining the periphery of the surgical site. A lip 32 extends radially outwardly from the uppermost edge of the outer flange 28 , as shown in FIG. 1, to define a support surface for a movable blade-receiving adapter 34 . The peripheral lip 32 has a peripheral edge 36 on its outermost side having a plurality of notches 40 thereon. The movable blade-receiving adapter 34 comprises a cylindrically-shaped housing for receipt of a portion of a paddle or blade arm 42 . The paddle or blade arm 42 has a lower end 44 which extends within the opening of the incision “I” on the radially inside of the protractor sleeve 10 . The blade arm 42 has an elbow portion 46 which extends through a bore the movable blade adapter 34 , for engagement therewithin. The adapter 34 has an innermost lip 48 and an outermost tab 50 , for secure engagement within the notches 40 on the peripheral edge 36 of the lip 32 . Thus, once the protractors level 10 is fully wound up and snuggly engaged within the channel 30 of the protractor stiffening, ring 12 , one or more movable blade adapters 34 may be secured to the top side of the stiffening ringer 12 , and retractor blades or paddles 44 may be juxtaposed therewithin to hold body organs out of the way of the surgical procedure during the treatment of the patient. A further embodiment shown in FIG. 2 discloses an L-shaped retractor ring 58 defined by an annular base 60 , having an inner flange 62 extending upwardly therefrom. A blade support station 64 may be arranged at various spaced-apart (i.e. approx. 30 degree) locations about the periphery of the annular base 60 of the L-shaped protractor ring 58 , as may be seen in FIG. 2 . The upper end of each blade support station 64 has an opening 66 therethrough, in radial alignment with the longitudinal axis of the protractor sleeve 10 about which it is disposed. A retractor blade or paddle 68 is arranged within the sleeve 10 , and may have an uppermost arm and elbow portion 70 which extends through the opening 66 of each lade support station 64 . The sleeve 10 and lower O-ring 18 are mated adjacent and below the incision “I” in the patient's abdomen as in the aforementioned embodiment. The sleeve 10 is wound up above about the uppermost 0 -ring 18 as in the aforementioned embodiment, the wound-up sleeve 10 and upper O-ring 18 mating in with the space “S” between the blade support stantions 64 and the inner flange 62 of the annular base 60 . Frictional engagement between the blade support stantions 64 and the inner flange 62 provides the tautness of the sleeve 10 . The retractor ring 58 provides the stiffness, as in the aforementioned embodiment, to the assembly, for support of the retractor blades and the paddles 68 in a circular pattern about the edge of the incision “I”. A further embodiment of the stiffening ring 74 , is shown in FIG. 3 A. The stiffening ring 74 comprises an “L-shaped” combination of an annular base 76 with an upstanding flange ring 78 . The flange ring 78 has an upper lip 80 to act as an anti-slip guard. The ring 74 is arranged so as to fit about the periphery of an incision “I” or wound site in a generally circular manner, as shown in combination with a protractor sleeve 82 in FIG. 3 B. The upper end of the sleeve 82 has an upper O-ring 84 which is rolled-up in the sleeve 82 and fitted over the lip 80 and into the corner of the L-shaped ring 74 for retention thereof and maintenance of the generally circular configuration of the sleeve 82 and incision “I” of the wound site. A further embodiment of the retractor arrangement of the present invention comprises the annular stiffener protractor ring 90 having an annular base portion 92 , similar to the aforementioned embodiment, with an inner upstanding flange wall 94 and an outer upstanding flange wall 96 . An annular channel 98 therebetween defines the trough for securing a rolled-up sleeve, not shown. A flexible resilient torroidally shaped chamber 100 may be attached to the lower side of the annular base 92 . This torriodally shaped chamber 100 provides an airtight fit between the stiffener ring 90 and the peripheral surface of the abdomen incision “I” about which the stiffener retainer ring 90 is placed. The to noidally-shaped chamber 100 may be filled with a resilient material or pressurizably actuated by a fluid fill conduit 102 . The outermost flange 96 may have a notch 104 circumferentially spaced around its outermost surface, so as to receive an O-ring 106 for sealing purposes. A cover or dome 108 may be arranged so as to snap over the outermost flange 96 of the stiffener ring 90 to provide containment, pressure, security and cleanliness for the surgical site. The cover or dome 108 has a peripheral lip 10 and corresponding groove 112 to engage the O-ring 106 on the outer flange 96 . The cover 108 may have a sealable instrument opening 114 therein, to permit laparoscopic instruments and or treatment arrangements or a surgeon's hand(s) to be disposed through the opening 114 to allow surgical procedures to be enclosively performed within that site. Thus what has been shown are a number of embodiments of stiffener rings, to provide rigidity to a protractor sleeve so as to both protect the periphery of the incision or wound site as well as to provide a base for support of retractor blades or paddles to hold organs in place or aside during a particular surgical procedure.

1a

This is a continuation of application Ser. No. 08/076,107 filed on Jun. 14, 1993, abandoned. BACKGROUND OF THE INVENTION This invention relates to an insect repellent and insecticide, particularly for bees and wasps which contains acetic acid and an essential oil such as an edible plant oil soluble in ethyl alcohol or a limonene. Insects breath by means of tubes which open at the body surface in spiracles. The tubes divide into very fine branches leading to all the organs. The spiracles are water repellant but oil may enter through them. U.S. Pat. No. 1,871,949 discloses a composition of matter and the process of preparing it as an insect and rodent repellent. Specifically, this patent teaches the use of mixing oil of peppermint, sodium benzoate, sulphonethylmethane, animal glue, wood alcohol and water. This composition apparently hardens and sets on the material in which it is placed but it is not fully effective in repelling insects. U.S. Pat. No. 3,122,473 discloses a composition of matter for repelling bees, consisting of acetic acid in an aqueous solution. This particular patent does not disclose the use of an essential oil. Insecticides previously used have taken a variety of forms. Some have been oil based and in practically every case, they have contained chemical compositions which, in certain concentrations, can become harmful to the environment. SUMMARY OF THE INVENTION The primary object of the invention is to provide a material for use in repelling and killing insects which is inexpensive to manufacture, is easily sprayed and is non-injurious to plant and animal life. I have discovered a composition of matter which includes certain ingredients which first changes the physiological behavior of the insect by upsetting its respiratory and ultimately all body systems of the insect. It repels and destroys the insect. Essentially the insecticidal and repellant composition consists of: 1. aqueous solution containing 4-8% by volume acetic acid 2. an essential oil in an ethyl alcohol solution A combination of 1 & 2 have a synergistic effect that destroys insects or repels them. This effect is determined by concentrations of formula. The essential oil, may be a hydrocarbon in the form of a derivative of limonene C 10 H 16 , that is present in many plant products such as orange oil, lemon peel, pine needles, peppermint and so forth. All of these components are used for human consumption and the solution is environmental safe and has a pleasant aroma. DESCRIPTION OF THE PREFERRED EMBODIMENT An aqueous solution containing 4-8% glacial acetic acid is commercially available in drug stores as vinegar (CH 3 COOH+H 2 O). It is theorized that the vinegar will upset the physiological balance of the insect and may also be effective in upsetting the circulatory system. Particularly when the vinegar is combined with limonene extract and particularly the mint extract which appears to be more effective, this mixture penetrates the spiracles causing an insult to the body systems of the insect which is incompatible with life. The oil acts as a carrier for the mixture to enable penetration through the spiracles. Practice of the invention is illustrated by the following examples: EXAMPLE 1 The solution I consisted of: 1 part aqueous solution 5% acetic acid; 3 part water; and 0.125 part oil of spearmint & peppermint in ethyl alcohol A collection of 672 active honey bees were taken from a hive and placed in an 11.97 ml glass container with an 11.43 cm diameter opening. The container was covered with a cotton mesh to allow for ventilation. Some bees clustered at various areas of the container while others flew about. A great buzzing noise was audible from the container. The bees were then sprayed through the mesh opening with the named solution I. Within twenty seconds, most of the bees flew to the bottom of the container and after two minutes, forty seconds, two bees maintained flying ability. At three minutes, 22 seconds, only one bee was flying. At four minutes, none of the bees had flying ability. Buzzing noise remained strong. At six minutes, abdomens having rapid in-and-out movement (one hundred ten over a one minute count) exhibited great inability to walk and buzzing noise was less audible. All of the bees exhibited the same behavior, some sooner than others. Some attempted to fly but could only flap their wings. Some attempted to walk but could not hold themselves up and collapsed. They formed an almost perfect ring on the outer portion of the base of the container, piling up on one another. The stronger and more resilient went toward the center base and attempted normal activity. After fifty-two minutes, none of the bees were able to walk and many appeared dead. The active bees continued to crawl over one another, some still attempting to spread their wings. Prior to their death, they took a supine position, had rapid erratic movement of their extremities and curled the distal portion of their bodies inward once or twice. They gradually become more inactive and passive. Total cessation of all movement of the 672 bees took three and one-half hours. EXAMPLE 2 A collection of 127 active honey bees were taken from a hive and placed in a 3.78 liter container with a 9.53 cm opening that was covered with cotton mesh to allow for ventilation. Twenty-five bees clung to the mesh covering, others clustered at various areas of the container. The named solution was sprayed through the mesh opening. The bees at the mesh opening rapidly dropped; some hanging on to one another forming a chain. All but seven bees dropped to the bottom of the container and exhibited the same behavior as described in Example 1. After twenty minutes, three bees remained at the mesh opening. After thirty minutes, one bee remained at the opening. After fifty minutes, the last bee dropped to the bottom of the container. Prior to death, all exhibited the same behavior as described in Example 1. EXAMPLE 3 When named spray was used outdoors and sprayed directly at the Vespa (wasp, yellow jacket) and Apis (bee), they became disoriented and had erratic flying behavior. They were unable to fly straight, some dropping to the ground and others attempting to fly away. They seemed to communicate the danger to one another. Visible insects would not come near the sprayed area. During the late summer, the Vespa (wasp, yellow jacket) were more aggressive, especially when humans would dine outside. They were more difficult to control so spraying became more effective when the dining or sitting area was sprayed prior to human use. When the spray solution was used in this manner, there seemed to be an invisible wall and when the Vespa (wasp, yellow jacket) or Apis (bee) would come close, the area seemed to have an invisible wall which made the insects fly away as soon as they came in contact with the sprayed area. Occasionally one or two bees or wasps would penetrate the sprayed area but would leave immediately when sprayed again, either by dropping or flying away. It was also noted in the open outdoor area that the spray was effective against other insects, including the mosquito which was effected in apparently the same manner in which the honey bees and yellow jackets were effected, although clinical studies were not conducted thereon. EXAMPLE 4 One hundred thirty-eight (138) active bees were taken from a hive and were placed in a 3.78 ml. glass container with a 9.53 cm diameter opening that was covered with cotton gauze to allow ventilation. The bees were flying about. A loud buzzing noise was audible. The bees were mist sprayed once with a solution II: 1 part pure glacial acetic acid; 1 part oil of anise in ethyl alcohol; and 1 part H 2 O. After 5 seconds, bees were dropping and flying to base of container. After 1 minute, eleven (11) of the bees were at the center of base of container. The remaining bees formed a ring at the outer aspects of the base of container and took a supine position. After 2 minutes, all the bees were exhibiting the same pre-death behavior as described in Example Number 1. After 3 minutes, all but six (6) of the bees appear dead. These six bees had slight movement of extremities. After 9 minutes, two (2) bees continue slight movement of extremities. After 10 minutes there was no movement. They had a shrivelled appearance. Death was instant for all but six of the bees. The anise mixture had a very pleasant aroma. EXAMPLE 5 One hundred twenty-seven (127) honey bees were taken from a hive and placed in a 3.78 ml. glass container with a 9.53 cm diameter opening that was covered with cotton gauze to allow ventilation. The bees were loudly buzzing and flying about. Solution III consisted of: 10 cc of sesame oil was blended with; 10 cc of 70% solution of C 2 H 5 OH. There was a slight separation of the mixture. This mixture was further blended with 10 cc 5% acetic acid and 10 cc of H 2 O. The mixture, while not foul smelling, did not have a pleasant aroma. The bees were mist sprayed with Solution III. After 2 minutes, all bees remain active. Six (6) bees remain at top of container at gauze opening. After 3 minutes, bees were sprayed a second time. Two remain at top of container. Most remain active. One bee attempting to fly. All bees have rapid erratic movement. After 7 minutes, two (2) bees remain at gauze of container opening. One (1) bee was attempting to fly. After 8 minutes, one (1) bee at container opening. After 9 minutes, no bees at top of container. Buzzing noise less audible. The bees formed a ring at outer aspects of base of container. After 10 minutes faint buzzing noise audible. After 12 minutes, two (2) bees attempting to walk. After 13 minutes none of the bees attempting normal activity. After 15 minutes movement decreasing. After 20 minutes ring formation at base of container unchanged. All of the bees appear to be dying. All are in supine position exhibiting the same pre-death behavior as described in Example Number 1. After 30 minutes many appear dead. After 36 minutes the bees appear to be shrivelling, all in a supine position. Slight audible buzzing noise. After 61 minutes, one (1) bee attempted to fly. After 90 minutes, eight (8) bees have slight movement. One (1) bee attempted to walk. All others are dead. EXAMPLE 6 One hundred twenty-one (121) active honey bees were taken from a hive and placed in a glass 3.78 ml. container with a 9.53 cm diameter opening that was covered with cotton gauze to allow ventilation. Loud buzzing noise was audible. Bees were then sprayed with Solution IV: 1 part of oil of lemon in ethyl alcohol; and 1 part glacial acetic acid. Within five (5) minutes the buzzing noise decreased. Some bees attempted flying. Bees were mist sprayed a second time. Fourteen (14) minutes later, bees had formed a ring at base of container and exhibited the same behavior prior to death as described in Example Number 1. After 41 minutes all bees were dead. EXAMPLE 7 One hundred twenty-eight (128) active honey bees were taken from a hive and placed in a 3.78 ml. glass container with a 9.53 cm diameter opening that was covered with cotton gauze to allow ventilation. Loud buzzing sound was audible. The bees were then sprayed with Solution V: 50% pure mint and pure peppermint extract (essential oils in ethyl alcohol solution) and 50% H 2 O. After 3 minutes, loud buzzing noise was audible and some bees attempted to fly. After 5 minutes buzzing continued. Activity slowed, but all bees are active. After 1 minute activity resumed. Within 30 minutes bees actively flying about. EXAMPLE 8 One hundred twenty-one (121) active honey bees were taken from a hive and placed in a 3.78 ml. glass container that was covered with cotton gauze to allow ventilation. Bees were then sprayed with Solution VI: 1.0 cc of pure glacial acetic acid; 1 cc oil of peppermint in 89% ethyl alcohol/water solution; 30 cc of H 2 O. After spraying bees, noise remained loud. All the bees were active, none were flying, some were falling to base of container. After 1 minute, bees were given three mist sprays. All bees were active, crawling on all areas of jar making a great humming noise; none are grouped together. After 3 minutes some bees are clustering on bottom of container. After 5 minutes, more bees dropped to base of container. Noise very audible. Bees continue to drop, cluster, and crawl over one another, remaining active. Many remain at top of container opening clinging to gauze. After 10 minutes bees were again sprayed. After 13 minutes, more bees clustering at base grouping together at left of base, some bees flying. After 15 minutes all bees continue to have active movement. After 20 minutes, bees seem to have some recovery. After 24 minutes bees were given 10 mist sprays. After 25 minutes, all but eleven (11) bees were at the base of container. After 26 minutes, fifteen (15) bees actively climbing sides of container; none are flying. Seven (7) bees remain at top of container; buzzing noise decreasing. After 29 minutes most of bees at base of container, crawling over one another. After 30 minutes, five (5) bees at top of container clinging to cotton gauze. After 34 minutes, one (1) active bee at top of container, buzzing audible, some bees attempting to fly. After 36 minutes, one (1) bee flying and one (1) bee remaining at cotton gauze. After 38 minutes, seven (7) bees attempting to crawl up sides of container. After 39 minutes, bees clustering in an oval formation at container base and up one side of container. After 40 minutes, zero (0) bees at top of container. After 41 minutes, ten mist sprays were given. After 46 minutes all bees clustered together. One bee attempting to fly. After 54 minutes, three (3) bees attempting activity. All remaining bees clustered at base. After 55 minutes, two (2) bees attempting activity. After 57 minutes, four (4) bees away from group attempting normal activity. After 64 minutes, eight (8) bees left cluster and attempted activity. Bees were given 10 mist sprays. One bee attempted flying, nine (9) bees attempting activity. All other bees clustered on half of base of container. After 1 hour 17 minutes, one (1) bee attempting great activity, two (2) bees attempting activity. All other bees forming smaller clusters. After 1 hour 22 minutes, clustering in two groups at base of container-some attempting to leave their cluster and trying to attempt normal activity. After 1 hour 25 minutes, seven (7) bees attempting activity, they remained clustered at base, many have movement. After 1 hour 38 minutes, seven (7) bees still attempting activity, remaining bees have little movement. One bee is flying. After 1 hour 55 minutes, the bees are gradually making recovery. Bees are moving and clustering up side of container. After 6 hours bees becoming more active with greater attempt at normal activity. No bees appear dead. After 9 hours 30 minutes all bees have fully attained and resumed normal activity, flying about and buzzing loudly. EXAMPLE 9 One hundred fifty-three (153) active honey bees were taken from a hive and placed in a 3.78 ml. glass container with 9.53 diameter opening which was covered with cotton gauze to allow ventilation. Solution VII: 1 cc pure olive oil was dissolved in 5 cc of 190% proof pure C 2 H 5 OH. This mixture was further combined with 5 cc pure glacial acetic acid and 200 cc of H 2 O. The bees were then sprayed with Solution VII. After 1 minute all bees sat in the base of container. After 4 minutes, five (5) bees returned to top of container. After 6 minutes bees have less activity, very audible buzzing noise. After 10 minutes, two (2) bees at top of container. Remaining bees formed two clusters at base of container. Noise less audible. After 17 minutes, one bee attempted flying. Many attempting to spread wings. After 25 minutes exhibiting less activity. One bee flying. Twelve bees are now in one cluster, remaining bees had clustered at opposite side of container. Eight bees are attempting activity. After 34 minutes, six bees are attempting activity. Two bees attempting to fly in short spans. After 35 minutes bees were sprayed again. Fourteen bees attempted to climb opposite side of container where bees are clustered. After 45 minutes, all bees clustered on one side of container. Two bees attempting activity. One bee attempting to fly. After 1 hour 10 minutes, three bees appeared dead in supine position, exhibiting the same pre-death behavior as described in Example Number 1. After 1 hour 20 minutes, all bees completely immobilized, all grouped together at outer aspects of base of container having very little movement. After 4 hours 40 minutes, three bees died. All remaining 150 bees resumed normal activity, flying about and buzzing loudly. Bees were then placed outside to fly away. Some bees did not leave container. Some flew away and three bees died after leaving container. EXAMPLE 10 Approximately 90 active honey bees were taken from a hive and were placed in a 3.78 ml glass container that was covered with cotton gauze to allow for ventilation. The following solution was used for this experiment: 30 parts H 2 O 1 part pure mint extract 1 part pure glacial acetic acid Bees were mist sprayed with this solution. Many of the bees flew to the base of the container. Many bees clung to gauze at the top of the container. Bees remained active at base of container. None flying. After 1 minute, three additional mist sprays were given. Bees very active, crawling over all areas of container. Audibly loud buzzing. None of the bees grouped. After 3 minutes, some bees were clustered at the base of the container. None are flying. After 5 minutes, bees continue to drop from cotton gauze covering to the base of the container. Many still remain clinging to cotton gauze. After 10 minutes, bees were mist sprayed again. After 14 minutes, more bees clustering at one side of base. More of the bees are grouped together. Some flying activity. After 20 minutes, bees are having some recovery. After 30 minutes, recovery activity increasing. Ten (10) mist sprays given through mesh gauze. All but nine (9) bees flew and fell to the base of container. Grouping and crawling over one another. After 50 minutes, no bees at top of container. One bee attempting to fly. Two bees attempting activity. After 1 hour, bees are clustered and quiet. Three bees away from others--attempting normal activity. No flying ability. After 1 hour 30 minutes, one bee flying. After 1 hour 55 minutes, bees gradually starting to recover. Bees moving in a cluster up one side of glass container. After 2 hours 30 minutes, bees becoming more active. Normal activity increasing. None of the bees appear dead. After 3 hours 30 minutes, all of the bees have recovered. Flying about container, buzzing loudly. Normal activity resumed. The initial spray of this solution repelled the bees. Additional sprays immobilized them. Bees were taken outside to fly away. Two bees stayed initially in the glass container; three bees flew out of container to the ground and died. The remaining bees flew into the environment. EXAMPLE 11 One hundred twenty-four (124) active honey bees were taken from a hive and placed in a 3.78 ml glass container with an opening of 9.53 cm that was covered with cotton gauze to allow for ventilation. Bees very active, buzzing loudly and flying about glass container. Bees were mist sprayed once with a mixture of: 1 part pure mint extract 1 part pure glacial acetic acid 1 part water Within five (5) seconds, bees dropped and flew to the base of container forming a ring at the outer aspects of container. All of the bees took a supine position. After 1 minute 50 seconds, all of the bees were exhibiting pre-death behavior. After 2 minutes 45 seconds, five (5) bees have slight movement of their extremities; remaining bees appear dead. After 4 minutes, three (3) bees continue to have slight movement of extremities. After 8 minutes, all movement had ceased. All of the bees had a shriveled appearance. With one mist spray of above described solution, death was instant for all but five (5) bees, who maintained slight movement.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57 and should be considered a part of this specification. BACKGROUND Field [0002] The present invention is directed to a sleeping garment and more particularly to a bed sheet with an integrated sleeping garment. Description of the Related Art [0003] Bed sheets are commonly known. With respect to infants and toddlers, sleeping garments, such as zip-up pajamas or body suits, sleep sacks and swaddle wraps are known. However, such sleeping garments do not inhibit the infant or toddler from moving (e.g., coming near the edges of cribs, bassinets, etc.), which is discouraged as being potentially dangerous, nor do they prevent the infant or toddler from trying to climb out of the crib or bed. Additionally, use of several separate sleeping components, such as bedding sheets, pajamas, blankets, can be expensive. Moreover, use of blankets or separate coverings has been discouraged to avoid suffocation hazards for infants. SUMMARY [0004] Accordingly, there is a need for an improved bedsheet with integrated garment that can allow a user (e.g., newborn baby, infant, toddler, child) to sleep comfortably and securely, while reducing the number of components and addressing some of the deficiencies noted above. Optionally, the garment can be a swaddle. [0005] In another aspect, there is a need for a bedsheet with integrated garment that can be used in hospitals (e.g., for newborn babies, premature babies) to hold babies securely while allowing access to the baby for medical procedures without having to take the baby out of the garment. The bedsheet can be fitted over a mattress (e.g., at home, in a hospital) and the baby (newborn baby, premature baby, infant) can be placed in a cavity or pocket in the blanket and portions of the garment fastened to secure the baby or infant within the garment. The garment can be a swaddle. [0006] In accordance with one aspect a bed sheet with an integrated swaddle garment is provided. The bed sheet comprises a bottom layer configured to extend over and removably attach to at least a portion of a mattress and a top layer configured to extend over at least a portion of the mattress, the top layer attached to the bottom layer and defining a cavity between the top layer and the bottom layer, the cavity configured to receive at least a portion of a baby or infant therein. The bed sheet also comprises a swaddle garment integrally attached to the top layer and comprising a pair of garment portions configured to wrap about at least a portion of a body of the baby or infant to enclose arms of the baby or infant. The pair of garment portions are configured to fasten to one another or to the top layer to securely hold the baby or infant in a swaddled position. The pair of garment portions are configured to define an opening at the proximal end of the swaddle garment to extend at least partially around a neck of the baby or infant when in use. The swaddle garment is configured to hold the baby or infant such that at least a portion of the baby or infant is disposed in the cavity between the top and bottom layers, the swaddle garment also configured to secure the baby or infant on the mattress while allowing the baby or infant to move while on the mattress without dislodging the bottom layer from the mattress. [0007] In accordance with another aspect, a bed sheet with an integrated swaddle garment is provided. The bed sheet comprises a bottom layer configured to extend over and removably attach to at least a portion of a mattress and a top layer configured to extend over at least a portion of the mattress, the top layer attached to the bottom layer and defining a cavity between the top layer and the bottom layer, the cavity configured to receive at least a portion of a baby or infant therein. The bed sheet also comprises a swaddle garment integrally attached to the top layer and comprising a pair of garment portions configured to wrap about at least a portion of a body of the baby or infant to enclose arms of the baby or infant. The pair of garment portions are configured to fasten to one another or to the top layer to securely hold the baby or infant in a swaddled position. The pair of garment portions are configured to define an opening at the proximal end of the swaddle garment to extend at least partially around a neck of the baby or infant when in use. At least one of the garment portions has one or more flaps that selectively cover a corresponding opening under the flap, the one of more flaps selectively movable between a closed position over the opening to cover the opening and an opened position to uncover the opening and allow access to at least a portion of the baby's or infant's body via the opening while swaddled within the swaddle garment. The swaddle garment is configured to hold the baby or infant such that at least a portion of the baby or infant is disposed in the cavity between the top and bottom layers, the swaddle garment also configured to secure the baby or infant on the mattress while allowing the baby or infant to move while on the mattress without dislodging the bottom layer from the mattress. [0008] In accordance with another aspect, a bed sheet with an integrated swaddle garment is provided. The bed sheet comprises a layer configured to extend over and removably attach to at least a portion of a mattress and define a cavity between the layer and the mattress, the cavity configured to receive at least a portion of a baby or infant therein. The bed sheet also comprises a swaddle garment integrally attached to the layer and comprising a pair of garment portions configured to wrap about at least a portion of a body of the baby or infant to enclose arms of the baby or infant. The pair of garment portions are configured to fasten to one another or to the layer to securely hold the baby or infant in a swaddled position. The pair of garment portions are configured to define an opening at the proximal end of the swaddle garment to extend at least partially around a neck of the baby or infant when in use. At least one of the garment portions has one or more flaps that selectively cover a corresponding opening under the flap, the one of more flaps selectively movable between a closed position over the opening to cover the opening and an opened position to uncover the opening and allow access to at least a portion of the baby's or infant's body via the opening while swaddled within the swaddle garment. The swaddle garment is configured to hold the baby or infant such that at least a portion of the baby or infant is disposed in the cavity, the swaddle garment also configured to secure the baby or infant on the mattress while allowing the baby or infant to move while on the mattress without dislodging the bottom layer from the mattress. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 shows one embodiment of a bed sheet with integrated garment. [0010] FIG. 2 shows another view of the bed sheet with integrated garment of FIG. 1 . [0011] FIG. 3 shows another embodiment of a bed sheet with integrated garment. [0012] FIG. 4 shows another view of the bed sheet with integrated garment of [0013] FIG. 3 . [0014] FIG. 5 shows another view of the bed sheet with integrated garment of FIG. 3 . [0015] FIG. 6 shows another view of the bed sheet with integrated garment of FIG. 3 . [0016] FIG. 7 shows another view of the bed sheet with integrated garment of FIG. 3 . [0017] FIG. 8 shows another view of the bed sheet with integrated garment of FIG. 3 . [0018] FIG. 9 shows another view of the bed sheet with integrated garment of FIG. 3 . [0019] FIG. 10 shows a cross-sectional side view of a bedsheet with integrated garment on a mattress. [0020] FIG. 11 shows a bottom view of a bedsheet with integrated garment on a mattress. DETAILED DESCRIPTION [0021] As used herein, a “mattress” is meant to encompass any cushioned sleeping pad, where the sleeping pad can be filled with resilient material, such as cotton, feathers, foam rubber, or can have one or more springs, as in a common mattress of a bed, or can be filled with water or air. As used herein, a “mattress” is meant to encompass different sized mattresses, such as crib size, twin size, full size, queen size and king size, as well as mattresses of different thickness, such as bassinet pads, crib mattresses and up to king size mattresses. [0022] FIGS. 1-2 show one embodiment of a bed sheet 100 . The bed sheet 100 can have a top layer 10 generally sized to extend along a length L and width W of a mattress 200 (see FIG. 11 ). The top layer 10 can at least partially define a sleeping garment 60 , which is further described below. [0023] The top layer 10 is attached to a bottom layer 20 (see FIG. 10 ) so as to define a pocket or cavity 30 therebetween into which a wearer of the sleeping garment can at least partially extend. In the illustrated embodiment, the top layer 10 is generally co-extensive with the bottom layer 20 . However, in other embodiments, the bottom layer 20 can extend over a larger area than the top layer 10 . In the illustrated embodiment, the top layer 10 is sewn to the bottom layer 20 along at least a portion of the periphery of the top layer 10 . In one embodiment, the periphery of the top layer 10 is sized to substantially correspond to the periphery of a top surface 210 of the mattress 200 (see FIG. 10 ) on which the top layer 10 rests. In another embodiment, the periphery of the top layer 10 is larger than the periphery that defines the top surface 210 of the mattress 200 so that the top layer 10 extends past the edges of said top surface and onto a side surface 220 of said mattress 200 . [0024] The bed sheet 100 can optionally include a generally water-resistant layer or water proof layer 40 disposed below the bottom layer 20 , so that the waterproof layer 40 is adjacent and in contact with the mattress 200 when the sheet 100 is placed on the mattress 200 , and so the bottom layer 20 is disposed between the waterproof layer 40 and the top layer 10 . In one embodiment, the top layer 10 is generally co-extensive with the bottom layer 20 and the waterproof layer 40 , and the three layers 10 , 20 , 40 are sewn together along at least a portion of the periphery of the top layer 10 . In one embodiment, the waterproof layer 40 extends along an area smaller than the top layer 10 , where the waterproof layer 40 extends along substantially the top surface 210 of the mattress 200 . In another embodiment, the waterproof layer 40 can extend along the same area as the top layer 10 , and can extend to the sides 220 or underside surface 230 of the mattress 200 . Advantageously, the waterproof layer 40 can at least partially stick or adhere to the mattress 200 during use (e.g., due to the affinity between the mattress material and material of the waterproof layer 40 ), which advantageously helps to maintain the bed sheet 100 in place on the mattress 200 and inhibits dislodgement of the sheet 100 during use (e.g., due to the user moving around, sitting up or standing up). In another embodiment, the water proof layer 40 can be excluded from the bed sheet 100 . In one embodiment, where the water proof layer 40 is excluded from the bed sheet 100 , the bottom layer 20 can be water resistant or water proof. [0025] In one embodiment, the top layer 10 can be made of a breathable fabric, such as cotton. However, in other embodiments, the top layer 10 can be of a stretchable material, such as 100% jersey cotton stretch material, which advantageously allows the user to comfortably move while having the sleeping garment 60 on. However, in other embodiments, the top layer 10 can be made of other suitable fabrics or textiles, including those made from natural or synthetic fibers (e.g., polyester). In one embodiment, the bottom layer 20 can be made of fabric. For example, in one embodiment, the bottom layer 20 can be made of 100% cotton flannel. However, in other embodiments, the top layer 10 can be made of other suitable fabrics or textiles, including those made from natural or synthetic fibers (e.g., polyester, terrycloth, bamboo). In one embodiment, the waterproof layer 40 can be made of a polymer material, such as plastic or vinyl coated polyester. However, in other embodiments, the waterproof layer 40 can be made of other suitable materials, such as a plastic material (e.g., natural, synthetic or semi-synthetic plastic material). [0026] The bed sheet 100 can have a side portion 50 configured to extend from the top layer 10 , along the sides 220 of the mattress 200 and to an underside 230 of the mattress 200 . In one embodiment, the side portion 50 and top layer 10 are one piece. In another embodiment, the side portion 50 and top layer 10 are separate pieces that are sewn together at said periphery. In one embodiment, the side portion 50 can be made of the same material as the top layer 10 . In another embodiment, the side portion 50 can be made of a different material than the top layer 10 . [0027] The side portion 50 can extend to the underside 230 of the mattress 200 and define an edge 52 (see FIG. 11 ). A resilient (e.g., elastic) band 54 can optionally be attached to at least a portion of said edge 52 or be integrated in the edge 52 (e.g., the side portion 50 can overlap the band 54 at said edge 52 so as to enclose the band 54 ). In the illustrated embodiment, the elastic band 54 can extend along the entire edge 52 . In one embodiment, the band 54 can have a generally oval shape when in the relaxed or unstretched condition. Advantageously, the band 54 substantially maintains the sheet 100 in place on the mattress 200 and inhibits the sheet 100 from dislodging or coming off the mattress 200 during use of the sheet 100 by a user, as further discussed below. In one embodiment, the band 54 has a thickness 54 t of about three inches. However, in other embodiments, the thickness 54 t can be less than or greater than three inches. [0028] With continued reference to FIGS. 1-2 , a garment 60 can be integrated into the bed sheet 100 so that the garment 60 and top layer 10 are a single piece. In the illustrated embodiment, the garment 60 is a swaddle with two portions 61 a, 61 b (e.g., two halves) that wrap around the baby or infant's torso and lower body so that the baby's or infant's arms are completely enclosed by the two portions 61 a, 61 b of the swaddle garment 60 . The two portions 61 a, 61 b can attach to each other, or to another portion of the garment 60 or top layer 10 with one or more fasteners. In one embodiment, the one or more fasteners can be hook and loop fasteners (e.g., VELCRO® or APLIX™). In another embodiment, the one or more fasteners can include one or more snaps. In still another embodiment, the one or more fasteners can include one or more zippers or buttons and button holes. The sleeping garment 60 can optionally have a waist band of a resilient and stretchable material. In use, the baby or infant can be placed in the pocket or cavity 30 of the bed sheet 100 and the two portions 61 a, 61 b of the swaddle garment 60 wrapped around the baby's or infant's torso so that his or her arms are completely covered by the swaddle portions 61 a, 61 b. [0029] FIGS. 3-9 show another embodiment of a garment 60 A integrated with the bed sheet 100 . The garment 60 A is similar to the garment 60 shown in FIGS. 1-2 , except as noted below. Thus, the reference numerals used to designate the various components of the garment 60 A are identical to those used for identifying the corresponding components of the garment 60 in FIGS. 1-2 , except that the reference numerals of the garment 60 A end with an “A”. Therefore the description for the various components of the garment 60 shown in FIGS. 1-2 is understood to apply to the corresponding components of the garment 60 A in FIGS. 3-9 , except as described below. [0030] As shown in FIGS. 3-9 , the garment 60 A is a swaddle with two swaddle portions 61 a, 61 b (e.g., swaddle halves) that wrap at least partially around the torso of the baby or infant, and which fasten to each other or to another portion of the garment 60 A or top layer 10 with one or more fasteners. As discussed above, the one or more fasteners can be hook and loop fasteners (e.g., VELCRO® or APLIX™). In another embodiment, the one or more fasteners can include one or more snaps. In still another embodiment, the one or more fasteners can include one or more zippers or buttons and button holes. The garment 60 A also has two flaps 63 A, 63 B that can be pulled to uncover corresponding openings 65 A, 65 B. In the illustrated embodiment, the openings 65 A, 65 B are sized to allow at least a portion of the baby's or infant's hand or arm to pass therethrough. In another embodiment, the openings 65 A, 65 B can be sized to not allow the baby's hands or arms to pass therethrough, but to allow access to a portion of the baby's hand or arm (e.g., to connect an iv line, as discussed further below). The flaps 63 A, 63 B can removably close the openings 65 A, 65 B via fasteners 67 B on the flap 63 B that releasably attach to fasteners 69 B on the opening. The fasteners 67 B, 69 B can be hook and loop fasteners (e.g., VELCRO® or APLIX™), though other suitable fasteners can be used. [0031] In the illustrated embodiment, the openings 65 A, 65 B are located on the swaddle portions 61 a, 61 b at a location that allows a portion of the baby's or infant's arms to pass through the opening, but lower than openings for sleeves would normally be (e.g., in a garment that has sleeves or openings that align with the baby's or infant's shoulders). This allows the swaddle garment 60 A to maintain the baby's or infant's shoulders and upper arms wrapped and swaddled. Advantageously, the flaps 63 A, 63 B and openings 65 A, 65 B allow access to the baby's arms, which can allow a caregiver, nurse or doctor to access the baby's arms, such as to check their pulse or to apply an iv (e.g., intravenous fluid delivery). As shown in FIGS. 3-4 , one flap 63 B can be open to allow access to the baby's left arm, while the other flap 63 A can be closed. In another embodiment, shown in FIG. 8 , the second flap 63 A can be opened to allow access to the baby's other arm through the opening 65 A. In still another embodiment, shown in FIG. 9 , the flap 63 B can be partially closed (via the fasteners 67 B, 69 B) to hold the baby's hand in place, for example, after an iv line has been attached to the baby's arm. [0032] Though the garment 60 A only shows two flaps 63 B, 65 B, one of skill in the art will recognize that the garment 60 A can in one embodiment only have one flap and corresponding opening. In another embodiment, the garment 60 A can have one or two additional flaps over openings located further down on the garment 60 A to allow access to the baby's or infant's legs or feet. [0033] Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above. [0034] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. [0035] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a sub combination. [0036] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. [0037] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. [0038] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment. [0039] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z. [0040] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree. [0041] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

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